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                                                                   Exhibit 10.15

          Confidential Materials omitted and filed separately with the
         Securities and Exchange Commission. Asterisks denote omissions.

                             MANUFACTURING AGREEMENT

                                 BY AND BETWEEN

                         XANODYNE PHARMACEUTICALS, INC.

                                       AND

                             J.B. LABORATORIES, INC.

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                             MANUFACTURING AGREEMENT
                                 BY AND BETWEEN
           XANODYNE PHARMACEUTICALS, INC. AND J.B. LABORATORIES, INC.

THIS MANUFACTURING AGREEMENT is made this 30th day of April 2007 by and between:

(1)  J.B. LABORATORIES, INC., a corporation organized under the laws of the
     State of Michigan and having a principal place of business at 13295
     Reflections Drive, Holland, Michigan 49424 ("Manufacturer"); and

(2)  XANODYNE PHARMACEUTICALS, INC., a corporation organized under the laws of
     the State of Delaware and having a principal place of business at One
     Riverfront Place, Newport, Kentucky 41071 ("Xanodyne"):

RECITALS:

WHEREAS Xanodyne now wishes to appoint Manufacturer as a manufacturer of the
products set forth in Attachment A and Manufacturer wishes to be appointed as a
manufacturer of said products; and

NOW, THEREFORE, in consideration of the premises and of the mutual covenants and
agreements set forth herein, Manufacturer and Xanodyne (individually a "Party",
collectively the "Parties") covenant and agree as follows:

ARTICLE 1: DEFINITIONS

In this Agreement the following expressions shall have the following meanings:

     "Actions" shall have the meaning set forth in Section 10.1.

     "Active Ingredient(s)" means the ingredients set forth in Attachment B for
     use in the Manufacture of Product.

     "Active Ingredient Specifications" means the specifications for the Active
     Ingredients as set forth in, referenced in or delivered pursuant to the
     Quality Agreement, as such specifications may be amended from time to time
     by mutual written agreement of the Parties.

     "Acquisition Cost" shall mean the actual invoiced price paid by
     Manufacturer to any Third Party for acquiring Raw Material for purposes of
     the Manufacturing of Product, including, but not limited to, shipping,
     handling and testing costs and customs duties incurred and paid by
     Manufacturer to any Third Party in connection with the acquisition of Raw
     Materials.

     "Affiliate" means any company, partnership or other entity which directly
     or indirectly controls, is controlled by or is under common control with
     the Party in question. For this purpose, "control" means the power to
     direct actions, management or policies whether

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     through the ownership of more than 50% of the issued share capital or other
     equity interest, by contract, declaration of trust or otherwise.

     "Agreement" means this Manufacturing Agreement as amended, restated or
     otherwise modified from time to time.

     "Aggrieved Party" shall have the meaning set forth in Section 10.1.

     "Applicable Laws" means all applicable federal, state, local and foreign
     laws, rules and regulations, including, without limitation, the United
     States Federal Food, Drug and Cosmetic Act, as amended, FDA regulations and
     those laws, rules and regulations concerning environmental requirements and
     the transportation of the Product if Manufacturer is responsible for
     shipment.

     "Batch" shall mean batches of Product in the sizes set forth in Attachment
     A hereto.

     "CGMP's" means the industry standards with regard to the interpretation and
     implementation of the regulations described in 21 CFR 210 and 211, as such
     may be amended from time to time.

     "Competing Product" means, with respect to a Product, (i) any
     pharmaceutical product which contains some or all of the Active Ingredients
     which directly competes with such Product; or (ii) any pharmaceutical
     product that an industry recognized data source, such as, by way of example
     and not exclusion, First DataBank, Gold Standard or Medispan, classifies as
     a substitutable product for such Product.

     "Confidential Information" shall be broadly construed and shall include,
     but is not limited to, any and all current and future proprietary product
     information, technical, financial, employment related, regulatory or
     legally sensitive information, customer names, addresses and related data,
     contracts, practices, procedures, software, hardware, files and other
     business information including but not limited to specifications,
     compounds, ingredients, formulae, recipes, samples, reports, methods,
     strategies, plans, documents, drawings, machines, tools, models inventions,
     patent disclosures, Know-How and materials that may be disclosed between
     the Parties heretofore or hereafter whether received or obtained prior to
     or after the Effective Date or developed as a result of entering into or
     performing this Agreement and whether in written, oral, electronic,
     website-based or other form including information obtained during facility
     tours, but shall not include information which:

          (a)  is in the public domain at the date of this Agreement or
               subsequently comes into the public domain otherwise than through
               breach of the terms of this Agreement by the recipient;

          (b)  the receiving Party can prove was in its possession at the date
               of disclosure or which subsequently comes into its possession
               without in either case being subject to any obligation of
               confidentiality to the disclosing Party; or


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          (c)  can be demonstrated to have been developed independently by the
               recipient without the aid of or reference to information
               disclosed to the recipient hereunder.

     "Cost" means the actual cost incurred by Manufacturer calculated in
     accordance with U.S. GAAP (United States generally accepted accounting
     principles) and using the normal standard cost accounting and allocation
     methods and procedures of Manufacturer consistently applied.

     "Delivery Date" means the date for the delivery of a Product shipment, as
     stated in the applicable purchase order for such shipment.

     "Effective Date" means the date first written above.

     "Expert" means a Third Party with expertise in pharmaceutical product
     manufacturing who is appointed by written agreement of Manufacturer and
     Xanodyne.

     "FDA" means the United States Food and Drug Administration or any successor
     thereto.

     "Force Majeure" means any circumstances beyond the reasonable control of a
     Party including, without limitation, flood, war, terrorism, insurrection,
     acts of God, governmental action or inaction, accident, strike, fire or
     explosion which are not the result of the Party's negligence.

     "Improved Technology" shall mean any development, improvement, modification
     or extension of a Party's Intellectual Property Rights arising under or
     resulting from performance of this Agreement or otherwise developed during
     the Term.

     "Intellectual Property Rights" means all rights in and to Confidential
     Information and Know-How, patents (including applications therefor and
     supplementary protection certificates) copyrights, trademarks, service
     marks or similar rights.

     "Know-How" means data, knowledge, techniques, inventions, designs,
     drawings, health and safety information including without limitation
     material safety data sheets, tests, reports, procedures, processes, models,
     manuals, formulae, systems, experiments, samples, specimens, results,
     statistics, research, tables of operating conditions and the like and all
     other know-how and information and including without limitation:

          (a)  analytical standards for analysis of Products and Raw Materials
               and/or the manufacture thereof;

          (b)  in-process quality assurance standards and methods of production;

          (c)  hazard data, storage requirements and manufacturing records;

          (d)  safety procedures, manuals and systems, process parameters; and

          (e)  Batch records.


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     "Liability" shall have that meaning set forth in Section 10.2.

     "Manufacture" shall have the meaning set forth in Section 2.1.

     "Manufacturer Know-How" means all Know-How owned by Manufacturer prior to
     the Effective Date and, subject to Section 8.2, developed by Manufacturer
     after the Effective Date without reliance on the Xanodyne Intellectual
     Property provided to Manufacturer hereunder.

     "Manufacturer Improved Technology" means any Improved Technology based upon
     Manufacturer's Intellectual Property.

     "Manufacturer Intellectual Property" means all Intellectual Property Rights
     owned by Manufacturer from time to time, including without limitation
     Manufacturer Improved Technology.

     "Manufacturing Problem" shall have that meaning set forth in Section 11.1.

     "Packaging Specifications" means the packaging and labelling specifications
     for the Product set forth in, referenced in or delivered pursuant to the
     Quality Agreement, as such specifications may be amended from time to time
     by mutual written agreement of the Parties.

     "Plant" means the premises of Manufacturer situated at 13295 Reflections
     Drive, Holland, Michigan or such other cGMP compliant facility of
     Manufacturer approved by Xanodyne for the purpose of Manufacture hereunder.

     "Product(s)" means Xanodyne's pharmaceutical product(s) identified in
     Attachment A in finished form to the relevant Product Specifications in
     both finished packaged product and bulk packaged product; provided,
     however, that any pharmaceutical products that would otherwise constitute a
     "Product" pursuant to the foregoing definition shall not constitute a
     "Product" if such pharmaceutical product is reformulated or is manufactured
     using Intellectual Property Rights and/or Know-How different than that used
     as of the date hereof.

     "Product Specifications" means the specifications for the Products set
     forth in, referenced in or delivered pursuant to the Quality Agreement
     including master batch records, process specifications and analytical
     methods, as such specifications may be amended from time to time by mutual
     written agreement of the Parties.

     "Quality Agreement" means the Quality Agreement between the Parties dated
     April 30, 2007 as may be amended, restated or otherwise modified from time
     to time, which is hereby incorporated herein by reference. The Quality
     Agreement is attached hereto as Attachment C.

     "Quarter" means a period of three (3) calendar months commencing January 1,
     April 1, July 1 and October 1 in each year during the Term of this
     Agreement provided however that if the Effective Date is a date other than
     the first day of a Quarter, the first Quarter


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     shall be that period beginning on the Effective Date and ending immediately
     before the next Quarter.

     "Raw Materials" means, in relation to each Product, the Active Ingredients,
     excipients and packaging materials used in the Manufacture thereof.

     "Raw Material Specifications" means the specifications relating to the
     handling, warehousing, and storage of Raw Materials as set forth in,
     referenced in or delivered pursuant to the Quality Agreement, as such
     specifications may be amended from time to time by mutual written agreement
     of the Parties.

     "Regulatory Authority" means any relevant government authority (or
     successor agency thereof) responsible for granting any regulatory approval
     or marketing authorization in connection with the Products or otherwise
     having jurisdiction over the Products or its marketing, manufacture or
     shipment, as applicable.

     "Renewal Term" shall have the meaning set forth in Section 12.1.

     "Specification" means each of the following as they relate to Active
     Ingredients, Raw Materials and/or Products as appropriate:

          (a)  the Product Specifications,

          (b)  the Raw Material Specifications,

          (c)  the Packaging Specifications, or

          (d)  the Active Ingredient Specifications,

     "Stock-out" means any point in time that Xanodyne has no inventory of
     Product on hand. "Term" shall have the meaning as set forth in Section
     12.1.

     "Third Party" means any person, or entity other than the Parties to this
     Agreement or any of their respective Affiliates, officers or employees.

     "Unit" shall mean the quantity of Product referred to in Attachment A.

     "Unit Price" means the Price of a Unit identified in Attachment A and
     established pursuant to Article 5 and includes the sole cost for
     Manufacturer to Manufacture and supply the Product to Xanodyne, including,
     without limitation the Cost of Raw Materials.

     "Xanodyne Improved Technology" means any Improved Technology based upon
     Xanodyne's Intellectual Property.

     "Xanodyne Intellectual Property" means all Intellectual Property Rights
     owned or used by Xanodyne or its Affiliates in relation to the Product(s)
     prior to the Effective Date or developed for or by Xanodyne after the
     Effective Date, including without limitation Xanodyne Improved Technology.


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     "Xanodyne Know-How" means any and all Know-How owned or used by Xanodyne or
     its Affiliates in relation to the Product(s) or Active Ingredients or the
     Manufacture thereof prior to the Effective Date and developed for or by
     Xanodyne after the Effective Date.

     "Year" means the period from the Effective Date to December 31, 2007 and
     each subsequent calendar year beginning January 1, 2008 thereafter during
     the Term of this Agreement.

ARTICLE 2: MANUFACTURE AND SUPPLY OF PRODUCTS AND RAW MATERIALS

2.1  Manufacture of Product. Manufacturer shall conduct exclusively for Xanodyne
     and its Affiliates the following activities in relation to each Product:
     blending, compressing, coating, testing and packaging and all activities
     related thereto, including, without limitation, warehousing and storage
     ("Manufacture") and shall supply Product to Xanodyne and Xanodyne's
     Affiliates pursuant to purchase orders delivered by Xanodyne to
     Manufacturer subject to the terms and conditions of this Agreement.
     Xanodyne shall purchase at least [**] percent ([**]%) of Xanodyne's annual
     requirements for each Product from Manufacturer, subject to the terms and
     conditions of this Agreement and in accordance with the following
     provisions.

     2.1.1 Manufacturer shall, subject to Section 3.2.2, Manufacture the
          quantity of Product ordered by Xanodyne and its Affiliates, and
          Manufacturer shall not manufacture, supply or sell the Products for or
          to any Third Party.

     2.1.2 All Product shall be Manufactured by Manufacturer at its Plant in
          accordance with the Specifications, using Xanodyne Intellectual
          Property where appropriate.

     2.1.3 Manufacturer shall have responsibility for the manufacture,
          processing, testing, storage, treatment and handling of all Product in
          accordance with the Specifications and the Quality Agreement,
          including processing, testing, storage, treatment and handling of Raw
          Materials. Manufacturer shall also have sole responsibility for
          disposing of all Product and wastes arising from Manufacturer's
          failure to comply with the Specifications and for performance of all
          of its obligations hereunder in accordance with all Applicable Laws.

2.2  Active Ingredient. At a minimum, Manufacturer shall order the necessary
     quantities of Active Ingredients at appropriate intervals to meet
     Xanodyne's Purchase Orders. Manufacturer will accommodate up to [**]% of
     Xanodyne's forecast, provided Purchase Orders are delivered pursuant to
     Section 4.1.

2.3  Raw Materials. Raw Materials, including Active Ingredients, excipients and
     packaging materials, shall be acquired by Manufacturer from Third Parties
     designated and approved by Xanodyne in writing pursuant to the Quality
     Agreement.

2.4  Expiry. All Finished Packaged Product Manufactured pursuant to this
     Agreement shall have an expiry period of not less than [**] months after
     shipment of the Product by Manufacturer. All Bulk Packaged Product
     Manufactured pursuant to this Agreement


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     shall be shipped to Xanodyne's designated warehouse or affiliates within
     [**] months from the date of manufacture.

ARTICLE 3: FORECASTS; ORDERS

3.1  Twelve Month Forecast. Simultaneously with the submission of the first
     purchase order for the Products and within 30 days of the beginning of each
     Quarter thereafter, Xanodyne shall deliver to Manufacturer for its review a
     forecast of Xanodyne's Unit requirements for each Product for each of the
     following 12 months. Except as provided in Section 3.2 and 2.1, the
     forecasts provided by Xanodyne pursuant to this Section 3.1 shall not be
     binding on Manufacturer or Xanodyne in any way.

3.2  Forecast Variances. The forecast for Product requirement for the first
     Quarter given pursuant to Section 3.1 shall constitute a binding obligation
     of Manufacturer to Manufacture and of Xanodyne to accept and purchase,
     quantities of Product set forth in such forecast as follows:

     3.2.1 Xanodyne shall be required to purchase no less than [**] percent
          ([**]%) of forecasted quantities in the first Quarter.

     3.2.2 Manufacturer shall be required, if requested by Xanodyne, to
          Manufacture and supply to Xanodyne up to [**] percent ([**]%) of
          forecasted quantities in the first Quarter, provided that purchase
          orders are issued pursuant to Section 4.1.

     All other forecasts under this Agreement and updates thereof shall be for
     the sole purpose of assisting Manufacturer in its planning and will not
     constitute an obligation of Xanodyne to purchase the quantities of Product
     indicated. Notwithstanding the foregoing, in the event a product that an
     industry recognized data source, such as, by way of example and not
     exclusion, First DataBank, Gold Standard or Medispan, classifies as a
     substitutable product for a Product is sold by a Third Party, Xanodyne's
     obligations set forth in Sections 3,2.1 with respect to such Product shall
     immediately terminate, except to the extent that Xanodyne will be obligated
     with respect to all open purchase orders.

ARTICLE 4: PURCHASE OF PRODUCT; DELIVERIES

4.1  Purchase Orders. Except to the extent the Parties may otherwise agree with
     respect to a particular shipment, Product shall be ordered by Xanodyne
     pursuant to written purchase orders, which shall be sent to Manufacturer
     with not less than [**]days' "lead time" prior to the Delivery Dates.
     Manufacturer shall supply Product in such quantities on the Delivery Dates
     therefor. Any increase in the quantities beyond the [**]% increase
     allowable pursuant to Section 3.1, or any acceleration of the Delivery
     Dates for any Product, shall be subject to Manufacturer's prior approval;
     provided that Xanodyne shall be responsible for any cost increases or
     incremental costs which may be incurred by Manufacturer in meeting such
     requests.

     4.1.1 Except to the extent Applicable Laws otherwise require, quantities
          actually shipped pursuant to a given purchase order may vary from the
          quantities reflected in such purchase order by up to [**]% and still
          be deemed to be in compliance


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          with such purchase order. Xanodyne shall only be invoiced and required
          to pay for the quantities of Product which Manufacturer actually
          delivers to Xanodyne.

     4.1.2 If a particular shipment is not delivered within 30 days of the
          Delivery Date, Xanodyne may in its sole discretion, on or after the
          31st day after such Delivery Date, impose a [**]% reduction in the
          Unit Price for such shipment. In addition, if such shipment has not
          been delivered within 60 days or 90 days after the Delivery Date,
          Xanodyne may in its sole discretion, on or after the 61st and 91st day
          after such Delivery Date, as applicable, impose additional [**]%
          reductions in the Unit Price for such shipment. Xanodyne will not be
          entitled to price reductions if any delay is solely attributable to
          actions or non-performance on Xanodyne's part.

4.2  Manufacturer shall furnish to Xanodyne with each shipment of Product
     ordered by Xanodyne hereunder, (i) a certificate of analysis; (ii) a
     certificate of conformance, reflecting that such Product conforms to the
     relevant Specifications, and (iii) all documentation required by Applicable
     Laws or any Regulatory Authority.

4.3  Xanodyne shall not be required to take receipt of a Batch of Finished
     Packaged Product with less than [**] months' expiry and Bulk Packaged
     Product past [**] months from the date of manufacture; provided that
     Xanodyne and Manufacturer may nonetheless negotiate in good faith for
     Xanodyne to purchase the Batch.

4.4  Delivery Terms. The terms of delivery for the Product shall be Free On
     Board (Incoterms 2000) Manufacturer's Plant. When designated for shipment
     to Xanodyne's designated warehouse, Xanodyne will designate the carrier for
     shipment from the Plant provided that Manufacturer has approved such
     carrier for the Plant, such approval not to be unreasonably withheld or
     delayed. Risk of loss and transfer of title shall stay with Manufacturer
     and shall not pass to Xanodyne until the carrier's receipt of the Product.

     When designated for shipment to other than Xanodyne's designated warehouse,
     Manufacturer shall pre-pay freight and add such amount to the invoice for
     the Product shipped. Xanodyne reserves the right to designate the carrier
     for shipment from the Plant provided that Manufacturer has approved such
     carrier for the Plant, such approval not to be unreasonably withheld or
     delayed. Risk of loss and transfer of title shall stay with Manufacturer
     and shall not pass to Xanodyne until the carrier's receipt of the Product.

ARTICLE 5: FINANCIAL PROVISIONS

5.1  Unit Price

     5.1.1 Subject to adjustments set forth in this Agreement, Xanodyne shall
          pay to Manufacturer the Unit Price for each Unit Manufactured and
          delivered by Manufacturer in accordance with the terms of this
          Agreement and the provisions set forth in Attachment A.

     5.1.2 All payments due hereunder to Manufacturer are due [**] days from the
          date of Xanodyne's receipt of Manufacturer's invoice, which invoice
          shall be sent out concurrently with shipment of Product.


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5.2  Raw Material/Active Ingredient Costs. The Cost of all Raw Materials and
     Active Ingredient acquired by Manufacturer for the Manufacture of Product
     shall be paid by Manufacturer and shall be incorporated into the Unit Price
     paid by Xanodyne for the Product.

5.3  Miscellaneous Costs. The following Costs shall be borne or allocated as
     follows:

     5.3.1 the Costs of auditing alternative suppliers shall be borne by
          Manufacturer unless the requirement of such additional supplier arises
          as a result of the direction or request of Xanodyne; in which case
          such Costs shall be borne by Xanodyne;

     5.3.2 the Costs of routine stability testing by Manufacturer shall be
          billed on an annual basis. Should additional stability testing beyond
          routine testing be required or requested by one of the Parties, the
          Parties shall negotiate in good faith regarding who shall bear the
          costs related to any such additional testing;

     5.3.3 Costs for Manufacturer to develop validation methodology as requested
          by Xanodyne shall be reasonably negotiated between the Parties for the
          account of Xanodyne.

5.4  Price Adjustments.

     5.4.1 Subject to the limitations set forth in Sections 5.4.2, 5.4,3 and
          5.4.5, Manufacturer shall have the right to adjust the Unit Price as
          of January 1, 2008 and each succeeding January 1 during the Term to
          reflect:

          5.4.1.1 the net percentage change in the Manufacturer's Costs of
               manufacture due to change in the Costs of Raw Materials
               (excluding (i) Raw Materials owned by Manufacturer previous to
               its change in purchase Costs of same and (ii) those Costs that
               are covered under one or more of Manufacturer's long-term
               purchasing agreements); and

          5.4.1.2 changes in (i) [**], (ii) [**], (iii) [**] or (iii) [**]
               (which costs are included in the Unit Price).

     5.4.2 Any Unit Price adjustment pursuant to Section 5.4,1 shall be
          effective on the first day of each January of the Term and applicable
          for such Year. Notwithstanding the immediately preceding sentence, no
          Unit Price increase shall be effective unless and until Xanodyne shall
          have received from Manufacturer at least 90 days prior written notice
          ("Unit Price Adjustment Notice"), which notice shall include
          reasonable supporting detail of the basis and calculations of
          Manufacturer's Cost changes. On or before October 1 of each Year,
          Manufacturer shall deliver such Unit Price Adjustment Notice to
          Xanodyne.

     5.4.3 In no event shall any increase in Unit Price pursuant to Section
          5.4.1 exceed [**] percent ([**]%) of the Unit Price for the Product in
          question for the previous Year. The Unit Price shall not be adjusted
          more than once per Year.


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          Notwithstanding the foregoing, in the case of an abnormal increase in
          one or more of the Raw Materials used by Manufacturer in manufacturing
          Product for Xanodyne, the two parties agree to negotiate in good faith
          a revised Unit Price. Manufacturer agrees to notify Xanodyne within 30
          calendar days of any abnormal increases in Raw Material costs that
          will necessitate such negotiations.

     5.4.4 The Unit Price may be adjusted to reflect the increase in Costs to
          Manufacture Product incurred by Manufacturer in respect of and at the
          time of implementing new material and mandatory safety or
          environmental requirements or any new material and mandatory FDA
          requirements, and which arise directly as a result of Manufacture for
          Xanodyne of Product and are not related to the Plant generally or to
          other products manufactured by Manufacturer at the Plant. Manufacturer
          shall initiate any anticipated variation in the Unit Price pursuant to
          this Section 5.4.4 by the delivery of a notice at least 30 days prior
          to the intended effective date of the proposed variation. This Section
          5.4.4 shall apply without regard to the limitations otherwise imposed
          by Sections 5.4.1, 5.4.2, and 5.4.3.

     5.4.5 No Unit Price adjustment pursuant to Section 5.4.1 or 5.4.4 shall
          apply to the quantities shown on those purchase orders which were
          issued to Manufacturer before the announced effective date of any
          adjustment. Manufacturer shall keep complete and accurate records,
          consistent with US GAAP, of the Costs associated with any Unit Price
          adjustment pursuant to Section 5.4.1 or 5.4.4. Manufacturer shall
          provide to Xanodyne reasonable supporting detail of the basis and
          calculations of Manufacturer's Costs upon proposing a Unit Price
          adjustment pursuant to Section 5.4.1 or 5.4,4.

     5.4.6 The Unit Price may be adjusted to reflect the increase in Costs to
          Manufacture Product incurred by Manufacturer which arise as a result
          of Xanodyne instructing Manufacturer to implement a change to a
          Specification. Xanodyne and the Manufacturer, prior to implementing
          any change to a Specification, shall agree upon any anticipated
          adjustment in the Unit Price pursuant to this Section 5.4.6 before
          Manufacturer shall be required to implement a change in the
          Specifications.

ARTICLE 6: CONFIDENTIAL INFORMATION AND PUBLICITY

6.1  Subject to Section 6.2 and 6.3 below, during the term of this Agreement and
     for a period often years following the expiration or termination for any
     reason of this Agreement each Party agrees that it will not (i) disclose to
     any Third Party any Confidential Information of the other Party received in
     relation to this Agreement during the Term, (ii) use such Confidential
     Information for any purpose other than in accordance with its rights
     hereunder and to carry out its obligations under this Agreement, or (iii)
     disclose such Confidential Information to or permit its use by any person
     other than such of the receiving Party's officers, employees,
     sub-contractors and agents who reasonably require access to the
     Confidential Information for the purpose of carrying out its rights and
     obligations under this Agreement and who have an enforceable legal
     obligation to the


                                      -10-

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     receiving Party of confidentiality and non-use of the Confidential
     Information substantially similar to the terms hereof.

6.2  The foregoing notwithstanding, the Confidential Information may be
     disclosed by the receiving Party in the event that it is required to do so
     by operation of law or by a governmental authority, but only to the extent
     that such disclosure has been so required or requested and provided that
     the disclosing Party has been given prompt notice to enable it to seek
     legal protection or confidential treatment of the Confidential Information.

6.3  Absent written authorization from the other Party, neither Xanodyne nor
     Manufacturer shall originate any publicity, news release or public
     announcement, written or oral, whether to the public or press, relating to
     this Agreement including its existence, the subject matter to which it
     relates or performance under it save only such announcement as in the
     opinion of counsel for the Party making such announcement is required by
     law to be made. Any such announcements shall be factual and as brief as
     possible.

ARTICLE 7: RECALLS

7.1  The decision to initiate a recall, market withdrawal or other corrective
     action (collectively, a "Recall") shall be made by Xanodyne in its sole
     discretion.

7.2  Xanodyne shall be responsible for conducting all Recalls and shall bear the
     cost of all Recalls of Product unless such Recall shall have arisen as a
     result of Manufacturer's breach of this Agreement or the negligence or
     wilful misconduct of Manufacturer, its Affiliates or their respective
     employees, agents, or contractors, in which case Manufacturer shall bear
     the cost of such Recall. For purposes of this Agreement, the cost of the
     Recall shall include amounts credited to Third Parties by Xanodyne with
     respect to Recalled Product.

ARTICLE 8: INTELLECTUAL PROPERTY RIGHTS

8.1  Manufacturer acknowledges and agrees that all Xanodyne Intellectual
     Property is the exclusive property of and belongs to Xanodyne or its
     Affiliates. Likewise, Xanodyne acknowledges that all Manufacturer
     Intellectual Property is the exclusive property of and belongs to
     Manufacturer or its Affiliates. Manufacturer shall be permitted to use the
     Xanodyne Intellectual Property exclusively and strictly for the purpose of
     carrying out its obligation to Manufacture the Product for Xanodyne or
     Xanodyne's designee under this Agreement.

8.2  Xanodyne Improved Technology whether solely developed by Xanodyne or
     jointly developed with Manufacturer, shall be the exclusive property of,
     and belong to Xanodyne. Likewise, Manufacturer Improved Technology, whether
     solely developed by Manufacturer or jointly developed with Xanodyne, shall
     be the exclusive property of and belong to Manufacturer; provided however
     that as to any. Improved Technology, each party shall grant to the other an
     irrevocable, transferable, non-exclusive, royalty-free license to utilize
     such technology or to sublicense such technology for the production of
     Product. Each Party covenants that it shall, upon the request of the other
     Party, assign


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     and transfer to the other Party any and all right, title and interest in
     any Improved Technology belonging to the other Party pursuant to this
     Section 8.2 without payment of additional consideration by such other
     Party.

8.3  For purposes of, and for the duration of this Agreement, each Party hereby
     grants to the other a non-exclusive, royalty-free, non-transferable license
     to use such Party's Intellectual Property Rights, including each Party's
     Improved Technology relating thereto, for the production, sale and
     distribution of Product supplied hereunder. In no event shall either Party
     be permitted to make use of the other Party's Intellectual Property or the
     other Party's Improved Technology for any other purpose or in the case of
     Xanodyne's Intellectual Property or Improved Technology for any other
     customer of Manufacturer, without the express written consent of the Party
     owning the Intellectual Property Rights or the Improved Technology, which
     consent may be withheld for any reason and which consent may be subject to
     a royalty to be agreed upon by the Parties.

ARTICLE 9: WARRANTIES AND COVENANTS

9.1  Manufacturer represents and warrants to Xanodyne that Product supplied to
     Xanodyne will be in strict compliance with the Specifications, at the time
     of sale and shipment to Xanodyne by Manufacturer, and will have been
     manufactured in compliance with cGMP and all provisions of this Agreement,
     the Quality Agreement and all Applicable Laws. Manufacturer will replace
     defective Products, provided that written notice of the defect is received
     by Manufacturer within [**] days after discover of such defect by Xanodyne,
     but not later than [**] months after deliver of the Products to Xanodyne;
     provided however that in the case of Product having a latent defect that
     could not have been discovered upon reasonable examination, Xanodyne must
     only give written notice of the defect within [**] business days of
     discovery of such defect.

9.2  Manufacturer represents and warrants to Xanodyne that Manufacturer is in
     material compliance with all Applicable Laws with respect to each facility
     and site to be used in Manufacture of Product and, to Manufacturer's
     knowledge, there are no circumstances or conditions which would reasonably
     be expected to prevent compliance from continuing during the duration of
     this Agreement or interfere with Manufacturer's ability to Manufacture
     Product, in each case, or create any financial liability on Xanodyne or its
     Affiliates.

9.3  Manufacturer represents and warrants to Xanodyne that at all times during
     the Term of this Agreement, Manufacturer will comply with and maintain in
     force all licenses, consents, permits and authorizations which may be
     required with respect to the Plant and Manufacturer's performance of its
     obligations hereunder, including without limitation, licenses and permits
     issued or required by the FDA and those required in relation to the
     generation, storage, treatment, transport, possession, handling and
     disposal of any waste and Manufacturer will Manufacture Product in strict
     compliance with all such licenses, consents, permits and authorizations.

9.4  Manufacturer represents and warrants to Xanodyne that all corporate action
     on the part of Manufacturer and its officers and directors necessary for
     the authorization, execution and


                                      -12-

<PAGE>

     delivery of this Agreement and the performance of all obligations of
     Manufacturer hereunder has been taken.

9.5  MANUFACTURER EXPRESSLY DISCLAIMS ANY WARRANTY THAT THE PRODUCT WILL BE
     MERCHANTABLE OR WILL BE FIT FOR ANY PARTICULAR PURPOSE; AND EXCEPT AS
     OTHERWISE STATED HEREIN, MANUFACTURER EXPRESSLY DISCLAIMS ANY OTHER
     WARRANTIES WITH RESPECT TO THE PRODUCT, EXPRESS OR IMPLIED, EXCEPT AS
     EXPRESSLY STATED IN THIS AGREEMENT.

9.6  Manufacturer and Xanodyne each represent and warrant that, as of the
     Effective Date of the Agreement, neither the Manufacturer Intellectual
     Property nor the Xanodyne Intellectual Property, respectively, currently
     infringes or violates any patent, trademark, trade name, copyright, trade
     secret or other proprietary right of any Third Party. Each Party represents
     and warrants that it shall take no action to intentionally infringe any
     patent, trademark, trade name, copyright, trade secret or other proprietary
     right of any Third Party during the Term.

9.7  Xanodyne represents and warrants to Manufacturer that, except to the extent
     that any of the following are the obligations(s) of Manufacturer, (a) the
     formulation, composition, use, distribution, marketing, and/or sale of
     Product shall comply in all material respects with regulatory requirements
     and Applicable Laws, and that Xanodyne will maintain all obligations with
     respect thereto; and (b) that Product manufactured in accordance with the
     Specifications will not infringe any patent or other Intellectual Property
     Right of any Third Party.

9.8  Manufacturer covenants that Manufacturer shall not, during the Term,
     modify, alter or otherwise change any manufacturing, processing or other
     component of the Manufacture, including without limitation, the
     installation of new or upgraded equipment used in the Manufacture, from
     that utilized on the Effective Date without first receiving Xanodyne's
     prior written consent to such modification, alteration or change, and
     subject to the penultimate sentence of the Section, which consent shall not
     be unreasonably withheld or delayed. Manufacturer shall deliver written
     notice of such proposed modification, alteration or change to Xanodyne at
     least [**] days prior to Manufacturer's intended implementation of such
     modification, alteration or change; provided, however, that in the case of
     an emergency Manufacturer shall only be required to provide such advance
     written notice as is practicable under the circumstances. Xanodyne shall
     have the right to reject and direct Manufacturer not to undertake any such
     proposed modification, alteration or change if, in Xanodyne's sole opinion,
     such modification, alteration or change will conflict with the
     Specifications or with any Applicable Laws. Xanodyne may, in connection
     with any modification proposed by Manufacturer, alteration or change
     initiated by Manufacturer, require Manufacturer to produce, at
     Manufacturer's sole cost and expense, validation verification batches and
     any records, reports or other documentation which may be reasonably
     required by Xanodyne for submission to the FDA or other Regulatory
     Authority having jurisdiction over such matters.


                                      -13-

<PAGE>

ARTICLE 10: LIABILITY AND INDEMNITIES

10.1 Each Party shall promptly notify the other, in writing, if it learns of any
     litigation, claim, administrative or criminal proceedings (collectively
     "Actions"), asserted or threatened against such Party (the "Aggrieved
     Party") for which such Party is entitled to indemnification hereunder from
     the other Party. With respect to any such Action, the other Party shall
     reasonably cooperate with and provide reasonable assistance to the
     Aggrieved Party as the Aggrieved Party may reasonably request. Such
     reasonable assistance may include, without limitation, providing copies of
     all relevant correspondence and other materials that the Aggrieved Party
     may reasonably request; provided, however, that any Confidential
     Information so provided shall be treated in accordance with the provisions
     of Article 6 hereof.

10.2 Xanodyne hereby agrees to defend, indemnify and hold harmless Manufacturer
     and each of its Affiliates and their respective officers, director and
     employees from and against any liabilities, claims, costs, expenses
     (including reasonable legal fees), loss or damage (each a "Liability") to
     the extent arising from (i) the, marketing, distribution, sale or use of
     Product, or (ii) Xanodyne's material breach of its representations,
     warranties or covenants under this Agreement or the Quality Agreement,
     (iii) any proceedings instituted by or on behalf of a Third Party based
     upon a claim that the manufacture, use or sales of the Products infringes a
     Third Parry's Intellectual Property Rights, except, in each case, to the
     extent that such Liability arises as a result of the breach of this
     Agreement or the Quality Agreement by Manufacturer, except in each case, to
     the extent that such liability arises as a result of the negligence or
     wilful misconduct of Manufacturer, its Affiliates or their respective
     employees, agents, or contractors..

10.3 Manufacturer hereby agrees to defend, indemnify and hold harmless Xanodyne
     and each of its Affiliates and their respective officers, directors, and
     employees from and against any Liabilities to the extent arising from (i)
     Manufacturer's breach of its representations, warranties or covenants under
     this Agreement or the Quality Agreement or (ii) the negligence or wilful
     misconduct of Manufacturer, its affiliates or their respective employees,
     agents, or contractors.

10.4 No indemnity may be claimed by or given to the Party seeking to rely on
     such indemnity:

     10.4.1 unless the Party claiming indemnity shall have notified the other
          Party of the relevant potential Liability upon becoming aware of such
          potential Liability except to the extent the failure to provide such
          notice does not prejudice the indemnifying Party's ability to defend
          or contest any suit or claim relating to such potential Liability,

     10.4.2 where the Party seeking indemnification has made any offer or any
          settlement without the prior written consent of the indemnifying
          Party, which consent shall not be unreasonably withheld or delayed,
          and

     10.4.3 unless the Party seeking indemnification has allowed the
          indemnifying Party to assume full control of all proceedings in
          relation to any such potential Liability


                                      -14-

<PAGE>

          within 30 days of having been given notice of such proceedings;
          provided, that (i) the Party seeking indemnification shall have the
          right to appoint independent counsel at its own cost to participate
          therein and (ii) no compromise or settlement may be effected by the
          indemnifying Party without the prior written consent of the other
          Party.

     10.4.4 The Party seeking indemnification shall cooperate fully with the
          indemnifying Party and its legal representatives in the investigation
          and defense of any action or claim with respect to which
          indemnification is sought hereunder.

10.5 Limitation of Liability. Neither Party shall be liable to the other Party
     for indirect, incidental, special or consequential damages, including
     without limitation any claim for damages based upon lost profits or lost
     business opportunity.

10.6 Insurance. Manufacturer and Xanodyne shall each maintain, throughout the
     Term of this Agreement, the following insurance: (i) products liability in
     amounts of not less than $6,000,000; and (ii) such property insurance and
     carrier insurance in amounts to cover the replacement value of Product and
     any and all property used in relation to Manufacture of Product. Each Party
     shall arrange for the other to be named as an additional insured under the
     relevant policies without liability for premiums. Each Party shall submit
     certificates of insurance, evidencing such insurance coverage, upon
     execution and delivery of this Agreement and thereafter when requested by
     the other Party.

ARTICLE 11: ANTICIPATORY BREACH

11.1 In the event that Manufacturer or Xanodyne becomes aware at any time of any
     matter, circumstance or event (a "Manufacturing Problem") which (i) would
     reasonably be expected to give rise to material delays in the shipment of
     Product, or (ii) reasonably indicate that the quality standards set forth
     herein and in the Quality Agreement have been materially compromised, or
     (iii) may reasonably give rise to Xanodyne's right to terminate under
     Article 12, such Party shall forthwith give written notice to the other
     Party of such matter, circumstance or event, the cause thereof, the
     anticipated length of such delay or shortfall, and the action to be taken
     to reduce, minimize or remove the adverse effects of any such delay. The
     matters, circumstances or events which shall give rise to the remedies set
     forth in this Section 11.1 include without limitation: (i) receipt by
     Manufacturer of a warning letter from a Regulatory Authority or a 483
     containing significant and meaningful findings affecting Product, (ii)
     continuous errors or inadequacies in batch processing or documentation as
     determined by Xanodyne's quality assurance department, (iii) circumstances
     which could in the opinion of Xanodyne reasonably lead to a warning letter
     from a Regulatory Authority, and (iv) release of one or more Batches of
     Product which do not meet quality standards for releasing Product as set
     forth in this Agreement, the Quality Agreement, the Specifications or
     Applicable Laws.

     11.1.1 Within fifteen (15) days of receipt of the notice given pursuant to
          Section 11.1, Xanodyne and Manufacturer shall cause a meeting to take
          place with a view to


                                      -15-

<PAGE>

          agreeing to such action as may be necessary to ensure that no
          interruption to supply or shortfall in quantities of Product occurs.

     11.1.2 Following the meeting referred to in Section 11.1.1, in the event
          that Xanodyne in its reasonable opinion determines that a
          Manufacturing Problem (not caused by the act, omission, or breach of
          any agreement by Xanodyne or its Affiliates) would be reasonably
          expected to occur and cannot be cured within [**] days of such
          meeting, Xanodyne shall have the right to reappoint Manufacturer as
          the secondary Manufacturer of the Product, reduce Xanodyne's
          purchasing obligation as set forth in Section 2.1 to the lesser of (i)
          [**]% of Xanodyne's total requirements for Product and (ii) the
          percentage of [**] supply, and arrange for an increase in the
          proportion of Product manufactured by any existing alternate
          manufacturer, or otherwise appoint an alternate manufacturer, for such
          time and in such quantities as may in its opinion be appropriate and
          necessary. Manufacturer shall provide such assistance and transfer
          Know-How as may be necessary for Xanodyne to have Product supplied at
          and by an alternate manufacturer of Xanodyne's choice, except that
          nothing shall be deemed to require Manufacturer to transfer
          Manufacturer's Intellectual Property Rights or Manufacturer's Improved
          Technology to the alternate manufacturer.

11.2 Specification Changes. In the event that Xanodyne or the FDA requires any
     change, alteration or modification to the Specifications, Xanodyne shall
     promptly advise Manufacturer in writing of such change, alteration or
     modification and Manufacturer shall promptly advise Xanodyne as to any
     scheduling and/or Unit Price adjustments which may reasonably and
     necessarily result therefrom. Prior to implementation of such change,
     alteration or modification, the Parties agree to negotiate in good faith in
     an attempt to reach agreement on (i) the new Unit Price for any Product
     Manufactured hereunder by Manufacturer which embodies such change,
     alteration or modification, giving due consideration to the effect thereof
     on Manufacturer's direct Manufacturing Costs for the Product, and (ii) any
     other amendments to this Agreement which may be necessitated by such
     changes (i.e. an adjustment to the lead time for purchase orders).
     Notwithstanding the foregoing, the Unit Cost shall not be increased as a
     result of any change, alteration or modification in the event such change,
     alteration or modification is related generally to the Plant or other
     products manufactured by Manufacturer in the Plant. Xanodyne agrees to
     reimburse Manufacturer for the reasonable expenses incurred by Manufacturer
     as a result of such change, alteration or modification, including, but not
     limited to, reimbursing Manufacturer for its validation and development
     costs, capital expenditure costs and costs for any packaging components or
     other materials rendered unusable as a result of such change, alteration or
     modification. If during the term of this Agreement Xanodyne amends or is
     required by law to amend the Specifications so as to render the Raw
     Materials for the Products obsolete, Xanodyne shall purchase from
     Manufacturer, at Manufacturer's Acquisition Cost, that amount of inventory
     of Raw Materials and/or Products, as the case may be, so rendered obsolete.

11.3 Non-conforming Product. In the event that any Product shall fail to
     strictly conform with any purchase order, warranty or term set forth in
     this Agreement, the Quality Agreement and/or the Specifications (referred
     to herein as Product that is "Defective," subject to a


                                      -16-

<PAGE>

     "Defect" or "Defective Product"), Xanodyne shall reject such Product by
     giving written notice to Manufacturer in accordance with Section 9,1. Any
     notice given hereunder shall specify the manner in which the Product is
     Defective. If it is determined by agreement of the Parties (or in the
     absence of agreement of the Parties, by a mutually acceptable independent
     laboratory or consultant whose fees shall be paid by the non-prevailing
     Party) that the Product was not Defective as of delivery to Xanodyne in
     accordance with Section 4,4., Manufacturer shall have no liability to
     Xanodyne with respect thereto. Otherwise (i) if Xanodyne has not yet paid
     for such Defective Product, Xanodyne shall not be required to pay for such
     Defective Product and Manufacturer shall credit Xanodyne's account the
     costs incurred by Xanodyne to return or destroy the Defective Product and
     (ii) if payment therefor has previously been made by Xanodyne, at
     Xanodyne's option, Manufacturer shall (i) pay Xanodyne the amount of such
     payment, (ii) offset the amount thereof against other amounts then due
     Manufacturer hereunder or (iii) replace such non-conforming Product with
     conforming Product at no additional cost to Xanodyne. In any case where
     Xanodyne expects to make a claim against Manufacturer with respect to
     Defective Product, Xanodyne shall not dispose of such Product without
     written authorization and instructions of Manufacturer either to dispose of
     the Product or to return the Product to Manufacturer, except for disposal
     for safety or regulatory reasons and except for retention of samples
     thereof for the purpose of determining any dispute, the costs of which
     shall be borne by the Party responsible for such non-conforming Product.

ARTICLE 12: TERM AND TERMINATION

12.1 Subject to Sections 12.2, 12.3 and 12.4, this Agreement shall commence on
     the Effective Date and shall expire five years from such date (the "Initial
     Term"). Manufacturer hereby grants to Xanodyne options to extend the term
     of the Agreement for further periods of one year (each a "Renewal Term")
     which options may be exercised by Xanodyne by giving notice to Manufacturer
     12 months prior to the expiration of the Initial Term or any Renewal Term,
     as applicable. Upon exercise of the option hereby granted, the term of the
     Quality Agreement shall be extended for the duration of this Agreement as
     extended. The Initial Term along with any Renewal Terms shall be referred
     to herein as the "Term."

12.2 Either Party shall be entitled to terminate this Agreement by notice given
     in writing to the other if:

     12.2.1 the other Party commits any material breach of any of the provisions
          of this Agreement and (in the case of a breach which is capable of
          remedy) fails to remedy the same within [**] days [**] days in the
          case of a breach involving the failure to pay a sum of money owed)
          after receipt of a written notice giving full particulars of the
          breach and requiring it to be so remedied; or

     12.2.2 the other Party becomes or is adjudged insolvent, makes an
          assignment for the benefit of its creditors, has a petition filed in
          bankruptcy for or against it (which petition is not dismissed within
          [**] days of filing) or goes into liquidation (except for the purposes
          of a bona fide amalgamation or other reorganization) or a


                                      -17-

<PAGE>

          receiver is appointed over al! or a major part of the property or
          assets of the other Party.

12.3 Xanodyne shall be entitled in its sole discretion to terminate this
     Agreement upon sixty (60) days notice given in writing to Manufacturer if:

     12.3.1 Manufacturer causes more than [**] Stock-outs per Year or an
          extended Stock-out of more than 30 days,

     12.3.2 Manufacturer's cumulative on-time delivery on the Delivery Date
          falls below [**] percent ([**]%) during any three (3) month period,

     12.3.3 one or more of Manufacturer's employees, agents or contractors is
          debarred by the PDA, or

     12.3.4 Xanodyne determines that it will no longer develop or market the
          Products; provided, however, that in the event Xanodyne determines to
          no longer develop or market less than all of the Products, Xanodyne
          may terminate this Agreement only as it relates to the Products it
          will no longer develop or market.

ARTICLE 13: CONSEQUENCES OF TERMINATION

13.1 Upon the expiration or termination for any reason of this Agreement:

     13.1.1 the terms of Articles 6, 7, 8, 9, 10 and 15 and Section 13.1 shall
          continue in full force and effect in accordance with their respective
          terms;

     13.1.2 Manufacturer and Xanodyne shall, upon request of the other, return
          to the other all Confidential Information received from it in relation
          to the Products, along with all records or copies thereof; or
          alternatively each Party may destroy Confidential Information upon the
          request of the other Party or may elect to destroy Confidential
          Information thirty (30) days following notice to the other if the
          other Party does not object to the destruction. In all events each
          Party or its counsel may retain one copy of the Confidential
          Information in a secure location for the purpose of complying with the
          Party's obligations hereunder, and in the event of destruction of
          Confidential Information shall certify to such destruction upon
          request of the other Party;

     13.1.3 Unless this Agreement is terminated by Manufacturer under Section
          12.2, if this Agreement is terminated prior to the expiration of the
          Term, Manufacturer shall continue the Manufacture of Product in
          accordance with the terms of this Agreement for such period as may be
          reasonably necessary for Xanodyne to transfer production to an
          alternative manufacturer including without limitation time to
          negotiate terms and qualify and validate any such Manufacturer; and
          Manufacturer shall otherwise Manufacture all outstanding orders;
          provided, however, that in no event shall Manufacturer be required to
          do any of the foregoing for any period beyond the earlier of (i) 18
          months after termination and (ii) the expiration of the Term.


                                      -18-

<PAGE>

     13.1.4 Manufacturer shall provide to Xanodyne, its Affiliates and/or any
          Third Party to which Manufacture of a Product is to be transferred
          such support as may be reasonably necessary to transfer technology and
          Manufacture in a timely manner to ensure no loss of or interruption in
          supply of Product in accordance with the following provisions:

          13.1.4.1 where termination occurs by Manufacturer pursuant to Section
               12.2 then Manufacturer will not be obligated to provide such
               support; and

          13.1.4.2 where termination occurs by reason of the termination by
               Xanodyne pursuant to Section 12.2 or 12.3, then reasonable
               support for such transfer will be provided by Manufacturer
               without charge to Xanodyne except for pre-approved out-of-pocket
               expenses incurred by Manufacturer in effecting the transfer for
               Xanodyne; and

          13.1.4.3 where termination occurs by reason of expiration then such
               support shall be provided by Manufacturer at reasonable charges
               to be agreed.

     13.1.5 In the event this Agreement is terminated by Manufacturer pursuant
          to Section 12.2 or by Xanodyne pursuant to Section 12.3.4, at the
          termination of this Agreement, Manufacturer shall invoice to Xanodyne,
          and Xanodyne shall pay, an amount equal to the cost of all Raw
          Materials, whether or not in the form of finished Product, in
          Manufacturer's possession or in transit to Manufacturer as of such
          date of expiration or termination, provided that Manufacturer
          demonstrates that such Raw Materials (i) were purchased in reasonable
          quantities in reliance on Xanodyne's most recently submitted forecast
          pursuant to Section 3.1 and (ii) are in compliance with all relevant
          Specifications and otherwise fit for commercial use; provided,
          however, that Manufacturer agrees to offset the amount due from
          Xanodyne pursuant to this Section 14.1.5 by the Acquisition Cost of
          any Raw Materials which Manufacturer may use for production of other
          products during the six months immediately following the date of such
          termination.

ARTICLE 14: FORCE MAJEURE

14.1 If either Party is unable to perform its obligations hereunder due to an
     event or occurrence constituting Force Majeure, it shall promptly notify
     the other Party of the nature and extent of the circumstances in question.

14.2 In the event of any delay in the performance of its obligations under this
     Agreement or the non-performance thereof by either Party due to Force
     Majeure, the Party so affected shall be under no liability for loss or
     injury suffered by the other Party thereby and the time for performance of
     the relevant obligations shall be extended accordingly provided it uses its
     reasonable endeavors to minimize the effect of and overcome or remove the
     cause of such Force Majeure.

14.3 In the event that either Party is prevented or delayed in performing any of
     its obligations under this Agreement due to Force Majeure for an aggregate
     period in excess of ninety


                                      -19-

<PAGE>

     (90) days in any twelve month period, then both Parties shall meet as soon
     as reasonably practicable to discuss in good faith how best to alleviate
     the circumstances in question.

ARTICLE 15: OTHER PROVISIONS

15.1 Agreement Controls. In the event of a conflict between the terms set forth
     in this Agreement and the terms contained in any purchase order or other
     documentation related to the supply of Product or the subject matter
     hereof, including without limitation, the Quality Agreement, the terms of
     this Agreement shall control.

15.2 Notices. Any notices, requests, estimates or other communications hereunder
     shall be deemed to have been properly given upon receipt thereof when sent
     via facsimile or nationally recognized next business day courier addressed
     to a Party at the respective following address.

          To Xanodyne:                       To Manufacturer:

          General Counsel                    Kelly DeVries, General Manager
          Xanodyne Pharmaceuticals Inc.      J.B. Laboratories Inc
          One Riverfront Place               13295 Reflections Drive
          Newport, KY 41071-4563             Holland, Michigan 49424
          Fax No: 859 371-6391               Fax No: 616-738-8709

15.3 Entirety. This Agreement and the Quality Agreement incorporated herein by
     reference constitute the entire agreement between the Parties with respect
     to the supply of Product; and these agreements shall supersede all previous
     arrangements and agreements between the two Parties in respect thereof.

15.4 Governing Law. This Agreement and the Quality Agreement shall be governed
     by and construed in all respects in accordance with the laws of the State
     of Michigan. Each of Xanodyne and Manufacturer consents to submit to the
     personal jurisdiction of the Federal Court for the Western District of
     Michigan or the courts of the State of Michigan located in Ottawa or Kent
     Counties if any dispute arises out of this Agreement.

15.5 Severability. If any term or provision of this Agreement or the Quality
     Agreement is held by any court or other competent authority to be void or
     unenforceable, the other provisions of this Agreement or the Quality
     Agreement and the remainder of the affected provision shall continue to be
     valid.

15.6 No Waiver. Failure by either Party on one or more occasions to avail itself
     of a right conferred by this Agreement or the Quality Agreement shall not
     be construed as a waiver of such Party's right to enforce such right or any
     other right.

15.7 No Agency. Nothing in this Agreement or the Quality Agreement shall create
     or be deemed to create any relationship of agency, partnership or joint
     venture between the Parties.

15.8 Assignment.


                                      -20-

<PAGE>

     15.8.1 Neither Party may assign or transfer or delegate the performance of
          this Agreement or any rights or obligations thereunder to any Third
          Party without the prior written consent of the other Party which
          consent shall not be unreasonably withheld or delayed.

     15.8.2 In the event that Manufacturer wishes to assign this Agreement,
          Manufacturer shall, prior to such assignment, procure an undertaking
          from the assignee in writing that, should Xanodyne consent to such
          assignment, such assignee would assume Manufacturer's obligations
          under this Agreement and be bound by all the terms and provisions of
          this Agreement. In addition, Manufacturer shall ensure that the
          assignee:

          15.8.2.1 is experienced in or has, or will have as a condition to such
               assignment, senior and operating management, together with
               personnel retained at the Facility, who are experienced in
               pharmaceutical manufacturing under cGMP, including finished
               pharmaceutical products;

          15.8.2.2 has reasonably sufficient financial resources and liquidity
               (including lines of credit) to satisfy the requirements for
               working capital necessary to operate the Facility in the manner
               required to Manufacture and supply Product and perform all the
               obligations of Manufacturer under this Agreement;

          15.8.2.3 is in good standing with the FDA and has, for the five year
               period prior to the proposed assignment of this Agreement, a
               satisfactory record of regulatory compliance with the FDA, the
               U.S. Environmental Protection Agency, the U.S. Occupational
               Safety and Health Administration and the counterpart state
               agencies or divisions thereof (as demonstrated to the reasonable
               satisfaction of Xanodyne), except to the extent any non
               compliance would not reasonably be expected to have a material
               adverse effect on the ability of such assignee to operate a
               pharmaceutical manufacturing facility like the Plant.

15.9 Expenses. Except as otherwise provided herein, each Party shall be solely
     responsible for its respective costs and expenses incurred in connection
     with preparation of this Agreement and the performance of its obligations
     hereunder, including, without limitation, any and all attorneys' or
     accountants' fees.

15.10 Use of Name. Neither Party shall have any right, express or implied, to
     use in any manner, the name or other designation of the other Party, or any
     other trade name or trademark of the other Party for any purpose, except as
     may be required by applicable law or regulation.

15.11 Counterparts. This Agreement and the Quality Agreement may be executed in
     any number of counterparts, each of which shall be considered an original
     and all of which taken together shall constitute one instrument.


                                      -21-

<PAGE>

IN WITNESS WHEREOF, the duly authorized representatives of the parties have
executed this agreement the day and year first above written:

XANODYNE/PHARMACEUTICALS INC.


By: /s/ S.A. Stamp
    ---------------------------------
Name: S.A. STAMP
Title: CHIEF FINANCIAL OFFICER


J.B. LABORATORIES INC.


By: /s/ Kelly DeVries
    ---------------------------------
Name: Kelly DeVries
Title: General Manager


                                      -22-

<PAGE>

                                  ATTACHMENT A

<TABLE>
<CAPTION>
Product                                Batch Size   Unit Cost
-------                                ----------   ---------
<S>                                    <C>          <C>
FINISHED PACKAGED PRODUCT
Duet tablets 100ct Bottle                 [**]      $[**]
Duet Chewable tablets 90 ct Bottle        [**]      $[**]
Stuart Prenatal tablets 100ct Bottle      [**]      $[**]

BULK PACKAGED PRODUCT
Duet tablets Bulk                         [**]      $[**]per [**] tablets
</TABLE>


                                      -23-

<PAGE>

                                  ATTACHMENT B
                               ACTIVE INGREDIENTS

DUET TABLETS

<TABLE>
<CAPTION>
Ingredients                         mg
-----------                        ----
<S>                                <C>
Acacia                             [**]
Ascorbic Acid                      [**]
Ascorbyl Palmitate                 [**]
Beta Carotene                      [**]
BHT                                [**]
Calcium Carbonate                  [**]
Cholecalciferol                    [**]
Corn Starch                        [**]
Croscarmeliose Sodium              [**]
Cupric Oxide                       [**]
Cyanocobaiamin                     [**]
Dicalcium Phosphate                [**]
dl-alpha Tocopherol                [**]
ferrous BisgSycinate               [**]
Iron Aid                           [**]
Folic Acid                         [**]
Gelatin (pork)                     [**]
HPMC                               [**]
Magnesium Oxide                    [**]
Magnesium Stearate                 [**]
Microcrystalline Cellulose         [**]
Mixed glycerides                   [**]
Niacinamide                        [**]
PEG                                [**]
Polysorbate 80                     [**]
Pyridoxine HCI                     [**]
Riboflavin                         [**]
Silicon Dioxide                    [**]
Sodium Aluminum Silicate           [**]
Sodium Ascorbate                   [**]
Sodium Benzoate                    [**]
Sorbic Acid                        [**]
Sucrose                            [**]
Thiamin Mononitrate                [**]
Titanium Dioxide                   [**]
Vitamin E Acetate                  [**]
Zinc Oxide                         [**]
</TABLE>


                                      -24-

<PAGE>

                                  ATTACHMENT B
                           ACTIVE INGREDIENTS (CONT.D)

<TABLE>
<CAPTION>
Duet Chewable Ingredients           mg
-------------------------          ----
<S>                                <C>
Acacia                             [**]
Ascorbic Acid                      [**]
Ascorbyl Palmitate                 [**]
Aspartame                          [**]
Beta Carotene                      [**]
BHT                                [**]
Calcium Carbonate                  [**]
Calcium Silicate                   [**]
Cholecalciferol                    [**]
Citric Acid                        [**]
Corn Starch                        [**]
Cupric Oxide                       [**]
Cyanocobalamin                     [**]
Dicalcium Phosphate                [**]
dl-alpha Tocopherol                [**]
dl-alpha Tocopheryl Acetate        [**]
FD&C Yellow #6 Lake                [**]
Ferrochel Amino Acid Chelate 20%   [**]
Ferrous Fumarate                   [**]
Flavor Debittering                 [**]
Flavor Orange                      [**]
Flavor Vanilla                     [**]
Folic Acid                         [**]
Fructooligosaccharides             [**]
Gelatin (fish)                     [**]
Hypromellose                       [**]
Magnesium Oxide                    [**]
Magnesium Stearate                 [**]
Mannitol                           [**]
Mixed glycerides                   [**]
Niacinamide                        [**]
Pyridoxine HCI                     [**]
Riboflavin                         [**]
Silicon Dioxide                    [**]
Sodium Aluminum Silicate           [**]
Sodium Ascorbate                   [**]
Sodium Benzoate                    [**]
Sodium Citrate                     [**]
Sorbic Acid                        [**]
Sorbitol                           [**]
Sucrose                            [**]
Thiamine Mononitrate               [**]
Xylitol                            [**]
Zinc Oxide                         [**]
</TABLE>


                                      -25-

<PAGE>

                                  ATTACHMENT B
                           ACTIVE INGREDIENTS (CONT.D)

<TABLE>
<CAPTION>
Stuart Prenatal Ingredients         mg
---------------------------        ----
<S>                                <C>
Xylitol                            [**]
Zinc Oxide                         [**]
Acacia                             [**]
Ascorbic Acid                      [**]
Ascorbyl Palmitate                 [**]
Beta Carotene                      [**]
BHT                                [**]
Calcium Carbonate                  [**]
Carnauba Wax                       [**]
Cholecalciferol                    [**]
Corn Starch                        [**]
Croscarmellose Sodium              [**]
Cyanocobalamin                     [**]
Dicalcium Phosphate                [**]
dl-alpha Tocopherol                [**]
Ferrous Fumarate                   [**]
Folic Acid                         [**]
Gelatin (pork)                     [**]
HPMC                               [**]
iron Oxide Red                     [**]
Magnesium Stearate                 [**]
Microcrystalline Cellulose         [**]
Mixed glycerides                   [**]
Niacinamide                        [**]
PEG                                [**]
Polysorbate 80                     [**]
Pyridoxine HC!                     [**]
Riboflavin (core)                  [**]
Silicon Dioxide                    [**]
Sodium Aluminum Silicate           [**]
Sodium Ascorbate                   [**]
Sodium Benzoate                    [**]
Sorbic Acid                        [**]
Sucrose                            [**]
Thiamin Mononitrate                [**]
Titanium Dioxide                   [**]
Vitamin E Acetate                  [**]
Zinc Oxide                         [**]
</TABLE>


                                      -26-

<PAGE>

                                  ATTACHMENT C
                                QUALITY AGREEMENT


                                      -27-

<PAGE>

                            QUALITY AGREEMENT BETWEEN

                          XANODYNE PHARMACEUTICALS INC.

                                       AND

                             J.B. LABORATORIES, INC.


                                        1

<PAGE>

                                QUALITY AGREEMENT

CONTENTS

<TABLE>
<S> <C>
1.  PARTIES
2.  QUALITY AGREEMENT
3.  ADMINISTRATIVE INFORMATION
4.  PRODUCTS
5.  DURATION OF AGREEMENT
6.  CONFIDENTIALITY
7.  SECURITY
8.  SUPPLY
    8.1  Premises
    8.2  Product Specification and Master Production Records
    8.3  GMP Guidelines
    8.4  Materials
    8.5  Master Production Record Approval
    8.6  Production
    8.7  Methodology
    8.8  Standard Operating Procedure
    8.9  Dates of Manufacture and Expiration
    8.10 Manufacturing and Equipment Data
9.  QUALITY ASSURANCE
    9.1  QC of Materials
    9.2  In-Process and Finished Product Testing
    9.3  Release Procedures
    9.4  Documentation
    9.5  Sampling
    9.6  Stability
    9.7  Deviations and Investigations
    9.8  Rejection of Product
    9.9  Dispute Resolution
    9.10 Regulatory Inspection
    9.11 Regulatory Actions at Xanodyne US
    9.12 Regulatory Investigations
    9.13 Manufacturing Audits
    9.14 Right to Audit
    9.15 Product Complaints, Recall
    9.16 Compliance Deficiencies
10. CHANGE MANAGEMENT
11. PRODUCT PROCESS VALIDATION
    11.1 Process
    11.2 Cleaning Validation
    11.3 Equipment, Computer, Facility, and Utilities Qualification
    11.4 Laboratory Qualifications
12. ANNUAL PRODUCT REVIEW, DRUG LISTING, AND ANNUAL REPORTS
    12.1 Annual Product Review
    12.2 Drug Listing
    12.3 Annual Reports
13. STORAGE AND SHIPPING
    13.1 Storage
    13.2 Packing and Labeling
    13.3 Mixing of Product
    13.4 Shipment of Product to Xanodyne
</TABLE>


                                        2

<PAGE>

<TABLE>
<S> <C>
14. CONTRACTUAL AGREEMENT
    APPENDIX I
    APPENDIX II
    APPENDIX III
</TABLE>


                                        3

<PAGE>

1.   PARTIES

     This Quality Agreement is effective as of April 30, 2007, by and between
     Xanodyne Pharmaceuticals, Inc., a Delaware Corporation having its
     corporate offices at One Riverfront Place, Newport, Kentucky 41071-4563
     (hereinafter referred to as "Xanodyne") and J.B Laboratories, Inc., a
     Michigan corporation having its principal offices at 13295 Reflections
     Drive Holland, Michigan 49424 (herein after referred to as "JB Labs").

2.   QUALITY AGREEMENT

     2.1 This Agreement supplements and is hereby incorporated by reference
     into, that certain Manufacturing Agreement between the Parties dated as of
     April 30, 2007 (the "Manufacturing Agreement") for each of the Products to
     which this Agreement relates. If such Manufacturing Agreements are not in
     place, the roles and responsibilities in this Agreement stand-alone.

     2.2 This agreement defines certain roles and responsibilities of JB Labs
     for services or materials supplied to Xanodyne or Affiliates, for
     commercial distribution to ensure compliance with applicable cGMPs. This
     Agreement is supplemental to and constitutes a part of the Manufacturing
     Agreement. The provisions of this Agreement are intended to be supplemental
     to and not in derogation from the terms of the Manufacturing Agreement and
     provisions contained herein shall be treated as supplemental to the
     Manufacturing Agreement and in particular but without limitation in
     relation to the application, compliance, verification and implementation of
     cGMP. To the extent any terms set forth in this Agreement conflict with the
     terms of any Manufacturing Agreement, the terms of the Manufacturing
     Agreement shall control. Defined terms used in this Agreement shall have
     the meaning set forth in Appendix I or as otherwise defined herein. Defined
     terms used in this Agreement that are not defined herein shall have the
     meaning set forth in the Manufacturing Agreement.

3.   ADMINISTRATIVE INFORMATION

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

4.   PRODUCTS

     A Product list is provided in Appendix I.

5    DURATION OF AGREEMENT

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


                                        4

<PAGE>

6.   CONFIDENTIALITY

     Confidential Information shall be governed by the terms of the applicable
     Manufacturing Agreement.

7.   SECURITY

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

8.   SUPPLY

     8.1  Premises

          8.1.1 JB Labs will Manufacture the Products at the Plant and will not
               use or transfer at a later date any of the Manufacturing
               operations for the Product(s) to Third Parties or other sites
               without the prior written agreement of Xanodyne Corporate Quality
               Assurance.

          8.1.2 JB Labs 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 Xanodyne
               Corporate Quality Assurance.

     8.2  Product Specification and Master Production Records

          8.2.1 JB Labs will Manufacture 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 Xanodyne. All
               such documentation must be approved by Xanodyne Corporate Quality
               Assurance (see section 11).

          8.2.2 JB Labs will select approved suppliers using quality assurance
               and purchasing evaluations, which verify compliance by the supply
               company with cGMP and Specifications. Where appropriate, an
               on-site audit of the supplier site by JB Labs and/or Xanodyne may
               be required. JB Labs will be responsible for auditing these
               suppliers, according to their written procedures, and perform any
               other task to confirm that the supplier is operating within cGMP
               and supplying Product that meets the Specifications. JB Labs will
               notify Xanodyne of any change with regards to an approved
               supplier.

               8.2.2.1 Raw Material Specification

                    If JB Labs has the responsibility in the Manufacturing
                    Agreement for providing Raw Material (excipients and active
                    ingredients), JB Labs will obtain from approved suppliers as
                    defined in 8.2.2. JB Labs will test Raw Materials to the
                    full Specification unless a supplier Certificate of Analysis
                    ("COA") is available from an approved supplier, in which
                    case, reduced testing may be employed upon mutual agreement
                    with Xanodyne Corporate Quality Assurance. Full testing must
                    be performed on a one lot per year minimum. Any reference
                    standards for testing that are supplied by Xanodyne or its
                    Affiliates must be accompanied by a COA listing expiration
                    date and any correction factors that need to be applied.


                                        5

<PAGE>

                    If Raw Material is provided by Xanodyne, JB Labs will obtain
                    and test Raw Materials to the full Specification unless a
                    Certificate of Analysis (COA) is available from an approved
                    supplier, in which case, reduced testing may be employed
                    upon mutual agreement with Xanodyne Corporate Quality
                    Assurance.

               8.2.2.2 Label Component Specifications

                    JB Labs will use only labels and labeling approved in
                    compliance with standards and Specifications provided or
                    approved by Xanodyne Corporate Quality Assurance.

               8.2.2.3 Packaging Component Specifications

                    JB Labs will obtain from approved suppliers as defined in
                    the appropriate Regulatory documentation and test-packaging
                    components to the full Specification unless a validated
                    supplier COC is available from a certified supplier. If a
                    COC is available, complete testing may not be necessary upon
                    written approval by Xanodyne Corporate Quality Assurance.
                    Packaging Specifications must be provided by Xanodyne
                    Corporate Quality Assurance.

     8.3  GMP Guidelines

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

     8.4  Materials

          8.4.1 Materials Procured by JB Labs

               JB Labs is responsible for ensuring that all Raw Materials
               procured for use in the Product(s) are in full compliance with
               the Specifications in accordance with 8.2. Where appropriate, Raw
               Materials shall be given a repass date upon the satisfactory
               completion of all-initial testing. Repass testing will be
               performed at defined time intervals to ensure the chemical and
               physical stability of the Raw Materials unless Xanodyne or the
               supplier provides an official expiration date. Xanodyne Corporate
               Quality Assurance may audit any JB Labs program that allows
               retesting or repassing of Raw Materials.

          8.4.2 Materials Provided by Xanodyne

               Raw Materials provided by Xanodyne may require acceptance testing
               by JB Labs to confirm that the Raw Materials are in full
               compliance with the Specifications. Where Xanodyne requires
               acceptance testing to be performed by JB Labs to ensure full
               compliance with Specifications then JB Labs shall undertake such
               acceptance testing. Should Xanodyne perform this testing it will
               be the responsibility of Xanodyne for ensuring that these Raw
               Materials are in full compliance with the Specifications. JB
               Labs is responsible for ensuring that all Raw Materials are used
               correctly, have the correct identity by testing identity on
               receipt, and have met the relevant analytical testing or COA
               requirements for the Batch.


                                        6

<PAGE>

     8.5  Master Production Record Approval

          JB Labs may transcribe the information (i.e. formulation, filling work
          order, packaging work order) into its own format and must obtain
          written approval from Xanodyne US Corporate Quality Assurance for each
          master document version before Manufacturing. JBL will provide a cover
          sheet for Xanodyne signature. Signed approval must be returned to JBL
          within [**] working days, unless otherwise agreed.

     8.6  Production

          The Products will be Manufactured in accordance with the manufacturing
          and packaging procedures set forth in the Specifications and Master
          Batch Records and additional internal JB Labs' site procedures. Such
          procedures must be made available for scrutiny during audits by
          authorized personnel of Xanodyne Corporate Quality Assurance.

     8.7  Methodology

          JB Labs will test using the approved methodology listed in the
          appropriate Specification.

     8.8  Standard Operating Procedures

          JB Labs is responsible for maintaining any Standard Operating
          Procedures (SOPs) required to make the Product in accordance with
          cGMPs and as described in compendial documentation as well as any
          other regulatory requirements. If JB Labs and Xanodyne agree that
          deviation from specific SOP's is appropriate, Xanodyne Corporate QA
          will provide written authorization for the deviation.

     8.9  Dates of Manufacture and Expiration

          8.9.1 Date of Manufacture

               JB Labs will determine the date of manufacture based on the first
               day of blending the Product (the first day the API is
               introduced).

          8.9.2 Expiration Date

               Xanodyne Corporate Quality Assurance will provide the appropriate
               formulas so JB Labs can calculate expiration dates for Batches to
               be manufactured.

     8.10 Manufacturing and Equipment Data

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


                                        7

<PAGE>

9.   QUALITY ASSURANCE AND CONTROL

     9.1  Laboratory Control of Materials

          9.1.1 Quality control of Raw Materials supplied by JB Labs or by
               suppliers to JB Labs will be undertaken by JB Labs in accordance
               with the Specifications and methods approved by Xanodyne
               Corporate Quality Assurance.

          9.1.2 JB Labs is responsible for investigating any laboratory out of
               specification (OOS) results per JB Labs' internal procedures.
               Each OOS investigation must be reviewed and approved by JB Labs'
               designated quality person and must evaluate if the failure has
               jeopardized the safety, efficacy or quality of the Product.
               Xanodyne Corporate Quality Assurance must be notified in writing
               as soon as is feasible, of a confirmed OOS value and JB Labs must
               forward the completed package to Xanodyne Corporate Quality
               Assurance upon conclusion of the investigation. The investigation
               process should be completed in a timely manner.

     9.2  In-Process and Finished Product Testing

          9.2.1 Raw Materials and packaging components

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

          9.2.2 JB Labs will perform all in-process and finished Product testing
               using the Specifications, finished Product attribute Acceptable
               Quality Level ("AQL"), and Methods of analysis listed in the
               release documentation list provided and approved by Xanodyne's
               Corporate Quality Assurance. JB Labs may subcontract testing in
               accordance with section 11.4.4.

     9.3  Release Procedures

          9.3.1 Product

               JB Labs is responsible for ensuring and certifying that the
               Product has been made according to cGMPs, as well as the
               Specifications and procedures documented in the Master Batch
               Record. This includes, but is not limited to, a complete and
               thorough review of the executed batch records. Upon Xanodyne
               request, copies of executed batch records will be forwarded to
               Xanodyne Corporate Quality Assurance by JB Labs upon completion
               of JB Labs review and approval process.

          9.3.2 Certificate of Compliance/Analysis

               Prior to release, a JB Labs Quality Assurance Representative will
               sign a Certificate of Compliance/Analysis confirming that the
               Product has been Manufactured, packaged and tested in accordance
               with cGMP and Applicable Laws and meets the requirements of the
               Master Batch Record and Specifications including a statement that
               any deviations identified during the manufacturing process have
               been satisfactorily closed. These documents will also include the
               lot numbers, reference to any associated deviations, associated
               batch expiry dates, and quantities in each shipment. The specific
               lot number will be the lot number identified on the executed
               batch record for the finished Product being released.


                                        8

<PAGE>

          9.3.3 Xanodyne Confirmatory Testing

               Xanodyne or its Affiliates may perform confirmatory testing to
               validate JB Labs' data.

     9.4  Documentation

          9.4.1 Requests for Full Documentation

               JB Labs agrees to supply Xanodyne or its Affiliates with any
               completed Manufacturing, packaging, testing, or stability data
               within a reasonable time period. Should the documentation be
               necessary to fulfill a regulatory agency request, the
               documentation should be provided within 1 business day of
               Xanodyne's written request.

          9.4.2 JB Labs will retain, at minimum, batch production records,
               quality control testing records, all records of shipments of the
               Product from JB Labs, all validation data and other documentation
               relating to the Product for the time periods required by
               Applicable Laws with respect to the Product plus one year.

               9.4.2.1 JB Labs shall make such records and data available for
                    review by Xanodyne at JB Labs' Plant upon at least [**] days
                    prior written notice from Xanodyne to JB Labs.

          9.4.3 JB Labs shall, upon Xanodyne's request, supply to Xanodyne a
               copy of its document retention policy. Upon termination or
               expiration of this Agreement, JB Labs will, upon Xanodyne's
               written request and at Xanodyne's expense, make copies of any
               records and data for Xanodyne.

     9.5  Retain Sampling

          9.5.1 Retain Samples - Raw Materials

               JB Labs will retain samples of active ingredient for at least one
               year beyond the expiry period of the Products in which used. The
               amount of sample retained will be twice the quantity required to
               carry out all of the tests required to determine of the material
               meets, its Specifications.

          9.5.2 Retain Samples - Products

               JB Labs will retain samples of the Products for at least one year
               beyond the expiry period. The amount of sample retained will be
               twice the quantity required to carry out all of the tests
               required to determine if the material meets it's Specifications.

     9.6  Stability

          9.6.1 Routine/Commercial Stability Program

               9.6.1.1 JB Labs is responsible for maintaining a routine
                    stability-testing program for the Products, and will provide
                    a stability summary to Xanodyne on reasonable request
                    intervals. Data will be provided to Xanodyne as requested.

               9.6.1.2 The stability program will be in compliance with any
                    license commitments as notified by Xanodyne. At a minimum
                    one lot of each Product, at each strength and in each
                    package type (largest to smallest) will be placed on
                    stability each year unless otherwise agreed to in writing by
                    JB Labs and Xanodyne. Bulk


                                        9

<PAGE>


                    stability will be performed once during the life of the
                    product to establish a repack date. The stability protocol
                    or any changes must be approved by Xanodyne Corporate
                    Quality Assurance.

          9.6.2 Development (Registration, R&D) Stability Program

               JB Labs will be responsible for performing any development
               stability required to support the Products. If that development
               stability is to support projects initiated by JB Labs, then JB
               Labs will design, execute and write reports for the program. All
               protocols for and reports from such work must be approved by
               Xanodyne Corporate Quality Assurance. If that development
               stability is to support projects initiated by Xanodyne, then
               Xanodyne will establish the protocols and JB Labs will develop,
               execute and write protocols and reports for the program when
               requested by Xanodyne.

          9.6.3 Stability Failures

               Any confirmed problems or out of Specification results which
               arise as a result of or during any of the stability programs will
               be communicated in writing to Xanodyne Corporate Quality
               Assurance in sufficient time for Xanodyne to comply with any
               regulatory requirements.

          9.6.4 JB Labs will supply Xanodyne's Corporate Quality Assurance
               department with completed stability results upon receipt of a
               written request.

     9.7  Deviations and Investigations

          9.7.1 Deviations

               Although no deviation from the approved Master Batch Record
               should occur, any deviation from the process during Manufacture
               must be carefully explained and documented in the batch records,
               justified and approved by JB Labs' Quality Assurance and
               production management, and included in the documentation package.
               Any process deviations will be forwarded to Xanodyne Corporate
               Quality Assurance via JB Labs after discovery of the occurrence.

               NOTE: A deviation is defined as any anomalous event that may
               occur during the processing of a Batch that is a departure from
               Specifications, approved procedures or validated processes.

          9.7.2 Failure Investigations and Out Of Specification (OOS) Results

               JB Labs is responsible for investigating any test result or
               in-process test that fails to meet Specification per their
               internal procedures. Each investigation will be reviewed and
               approved by JB Labs' designated Quality person. The investigation
               must evaluate if the failure has jeopardized the safety, efficacy
               or quality of the Product. Xanodyne must be notified in writing
               of a confirmed OOS value and JB Labs must forward the
               investigation results to Xanodyne Corporate Quality Assurance
               upon conclusion of the investigation.

          9.7.3 JB Labs will notify Xanodyne Corporate Quality Assurance
               forthwith if any problems are discovered that may impact Product
               Batch(s) previously shipped to Xanodyne or its Affiliates
               identifying the Batches in question.


                                       10

<PAGE>

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

     9.8  Rejection of Product

          9.8.1 JB Labs will notify Xanodyne Corporate Quality Assurance in
               writing of any Batch rejected by JB Labs. This communication
               shall be accompanied by a completed investigation with regard to
               the failure and include evaluation of effect of failure on other
               Batches.

          9.8.2 Xanodyne or its affiliates will notify JB Labs of any problems
               thought to be due to Manufacture or stability, which are found
               during the distribution of the Product. When requested by
               Xanodyne, JB Labs will promptly perform investigations for these
               problems. Investigation results will be forwarded to Xanodyne as
               required.

     9.9  Dispute Resolution

          In the event that a dispute arises between JB Labs and Xanodyne or its
          Affiliates in the analysis of the Products, the resolution will
          proceed in stages. The first stage requires direct communication
          between analysts from both Parties to determine that the Methods of
          analysis are the same and are being executed in the same manner at
          both sites. Second, carefully controlled and split samples should be
          sent from one site to the other in an attempt to reach an agreement.
          Should there be a failure to achieve resolution, analysts from both
          Parties will be required to meet to work through the analysis of a
          mutually agreeable sample. Notwithstanding the foregoing, Xanodyne
          Corporate Quality Assurance retains at all times the right to
          determine Product release status for commercial distribution.

     9.10 Regulatory Inspections

          Xanodyne's Vice President or Director of Corporate Quality Assurance
          will be notified, as soon as is feasible, of any inspections by a
          Regulatory Authority related to Xanodyne Products. Should the FDA
          issue a warning letter or any observations related to Product to JB
          Labs, a copy of these documents will be forwarded to Xanodyne
          Corporate Quality Assurance as soon as is feasible.. Examples of
          observations related to Product include without limitation,
          observations issued regarding a packaging line, or quality control
          testing laboratory. If necessary, JB Labs may black out names of other
          customers or products to protect confidentiality. Copies of formal
          response letters from JB Labs including the 483 observations to the
          FDA that relate to the Product impact will also be forwarded to
          Xanodyne Corporate Quality Assurance. JB Labs will consider Xanodyne's
          comments and suggestions regarding any citations or observations that
          specifically relate to the manufacture of Xanodyne's products.

     9.11 Regulatory Actions at Xanodyne

          Xanodyne or its Affiliates will notify JB Labs of any inspections or
          regulatory actions on the Products that may impact JB Labs.
          Additionally, Xanodyne will immediately forward any regulatory
          correspondence concerning the Manufacture of the Products to JB Labs.

     9.12 Regulatory Investigations

          JB Labs is responsible for supporting all Batch record investigations
          associated with regulatory actions. Xanodyne Corporate Quality
          Assurance must be notified of any such events.


                                       11

<PAGE>

     9.13 Manufacturing Audits (MA)

          9.12.1 Annual MA: Xanodyne shall have the right to conduct [**]
               Manufacturing Audit as defined in section 9.13.4) per year (such
               annual Manufacturing Audit to be hereinafter referred to as an
               "Annual MA").

          9.12.2 Event MA: In addition to the Annual MA, in the event that (i)
               JB Labs receives 483 Observations or a "Warning Letter" from the
               FDA or any foreign equivalent outside the USA relating to the
               Manufacture of the Product by JB Labs, (ii) JB Labs has received
               a DEA "Letter of Admonishment" or similar notice alleging
               non-compliance, (iii) Xanodyne has rejected a Batch of Product
               where it has been agreed or determined that such Product failed
               to meet Specifications or cGMP or (iv) Xanodyne or JR Labs shall
               have received a series of complaints (i.e. [**] complaints on at
               least [**] lots of Product determined to have been a result of
               operations at JB Labs) from Third Parties within any year
               relating to the Manufacture of a Product (individually or
               collectively, an "Event"); Xanodyne shall have the right to
               conduct additional Manufacturing Audits according to the terms
               specified in Section 9.13.4 below (such Manufacturing Audit or
               Audits to be hereinafter referred to as an "Event MA").

          9.12.3 Routine Visits. It is agreed that Xanodyne may arrange, routine
               observational visit to the Plant(s).

          9.13.4 Manufacturing Audit: For purposes of this Agreement, the term
               "Manufacturing Audit" shall mean an audit of JB Labs' Plant for
               the Product by no more than [**] employees and/or [**]agents of
               Xanodyne for purposes of reviewing JB Labs' procedures and
               processes used in Manufacturing the Products, unless otherwise
               agreed. Any such agents shall be qualified to conduct
               manufacturing audits, shall comply with all JB Labs' facility
               rules regarding safety and security notified by JB Labs to
               Xanodyne and its employees and agents. Each Manufacturing Audit
               shall be conducted during JB Labs' normal business hours and upon
               at least fifteen (15) days' prior written notice to JB Labs in
               the case of an Annual MA, or with prior notice to JB Labs in the
               case of an Event MA. In all cases Xanodyne 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 JB Labs' Plant. During a
               Manufacturing Audit, upon Xanodyne's request, JB Labs shall make
               available for Xanodyne'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,
               Xanodyne shall have the right to obtain copies of such batch
               records with respect to the Product(s), provided however, that
               Xanodyne pays JB Labs for its reasonable costs associated with
               making such copies. All costs of an Event MA shall be borne by
               Xanodyne unless the requirement for audit arises as a result of
               the negligence of JB Labs or the breach of the terms of this
               Agreement or the Manufacturing Agreement by JB Labs, in which
               case JB Labs shall absorb all costs associated with the audit.

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


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<PAGE>

               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;

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

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

     9.14 Right to Audit

          9.14.1 Xanodyne or Xanodyne Affiliate representatives will be escorted
               at all times by JB Labs personnel.

          9.14.2 Audit Procedures

               9.14.2.1 An exit meeting will be held with representatives from
                    JB Labs and Xanodyne to discuss significant audit
                    observations.

               9.14.2.2 Xanodyne will provide a written report of all
                    observations within 30 days to JB Labs. Within 30 days of
                    audit report receipt, JB Labs will provide a written
                    response to all findings that details corrective action to
                    be implemented. JB Labs will follow up to ensure that all
                    corrective actions are implemented. Xanodyne may confirm
                    follow-up action by performing a follow-up audit separate
                    from the Annual MA or through documentation exchange.

     9.15 Product Complaints, Recall

          9.15.1 Product Complaints

               Xanodyne Corporate Quality Assurance shall maintain complaint
               files with respect to the Product (s) in accordance with cGMP's.
               Xanodyne Corporate Quality Assurance is responsible for receiving
               and initially investigating any complaints and will notify JB
               Labs of any complaint potentially resulting from any
               manufacturing defect that may impact the Product quality. JB Labs
               will investigate any Product complaints and provide a report to
               Xanodyne within 30 days. The investigation shall be completed in
               accordance with all cGMP regulations and any other Applicable
               Laws. Xanodyne shall have responsibility for reporting all
               complaints relating to the Product to the FDA and any other
               Regulatory Authority, including, but not limited to, complaints
               relating to the Manufacture of the Product as well as adverse
               drug experience (ADE) reports.

          9.15.2 Product Recall

               If Product Recall is related to product manufactured by JB Labs,
               JB Labs, in conjunction with Xanodyne Corporate Quality Assurance
               will be responsible for instituting a Product Recall. Prior to
               initiation of any recall, Xanodyne will notify JB Labs of any
               Recall that may be due to JB Labs. In the event that the
               companies disagree about the need for a recall, every effort will
               be made to resolve the issue. If no resolution is reached, both
               JB Labs Quality and Xanodyne Quality will consult with the
               regulatory authorities together to obtain the agency's
               recommendation concerning the need for a recall. The companies
               will abide by the agency's recommendation. JB Labs will work with
               Xanodyne and


                                       13

<PAGE>

               Xanodyne's Affiliates to investigate and coordinate the Recall.
               JB Labs will provide a rapid initial response and a full report
               within [**] working days. Should JB Labs have a Recall for a
               product other than a Xanodyne product, the investigation should
               extend to the procedures and practices associated with the
               manufacture of that product and JB Labs will promptly notify
               Xanodyne should the procedures or practices impact the
               manufacture of Xanodyne's products.

     9.16 Compliance Deficiencies

          Should JB Labs become aware of any issues that could affect the
          quality, safety, identity or efficacy of any Product produced at their
          facility, JB Labs will notify Xanodyne Corporate Quality Assurance in
          writing as soon as is feasible.

10.  CHANGE MANAGEMENT

     Product specific Master Batch Records, and Specifications will be approved
     by both Xanodyne's Corporate Quality Assurance Department and JB Labs'
     Quality Department. No changes to the above documents may be implemented
     without the signed authorization from an authorized member of the Xanodyne
     Corporate Quality Assurance Department. A signature will be required within
     [**] working days for documents sent to Xanodyne for change approval. All
     required regulatory approvals will be obtained prior to implementation.
     Variations to established production procedures may be initiated by either
     Party, but must be agreed to in writing by the authorized members of the
     Quality Assurance Departments of both Parties before implementation. The
     release status of the Product produced under a variation will be decided as
     part of the variation approval process. Quality Assurance Departments of JB
     Labs or Xanodyne will have the right to assign a final disposition of
     "rejected" to the batch should they conclude that such action is
     appropriate. Changes to the facility or equipment which have significant
     impact on Xanodyne's products shall be forwarded for review by Xanodyne's
     Corporate Quality Assurance prior to implementation.

11.  PRODUCT AND PROCESS VALIDATION

     11.1 Process

          JB Labs is responsible for ensuring that the process for Manufacture
          is validated. The validation should ensure that the process is capable
          of consistently achieving the Product's Specifications. JB Labs will
          not use any validation protocol or issue a report unless Xanodyne
          technical personnel and Xanodyne Quality Assurance have first approved
          them. Xanodyne will approve or reject all protocols and validation
          reports within 5 working days of receipt. Process validation batches
          may be shipped prior to completion of the validation reports, if a
          letter of authorization is provided by Xanodyne Corporate Quality
          Assurance.

     11.2 Cleaning Validation

          11.2.1 JB Labs is responsible for ensuring that adequate cleaning is
               carried out between batches of different products to prevent
               contamination.

          11.2.2 JB Labs will establish cleaning validation limits for the
               Product. The cleaning procedure and analytical methodology may be
               reviewed by Xanodyne upon request. Xanodyne will disposition all
               protocols and cleaning validation reports within [**] business
               days of receipt.

          11.2.3 JB Labs is responsible for having appropriate cleaning
               procedures for Product(s) Manufactured on non-dedicated
               equipment. JB Labs must provide evidence of appropriate


                                       14

<PAGE>


               equipment cleaning results as soon as is feasible upon receipt of
               request from Xanodyne. Cleaning data must be made available
               during an Annual or Event MA.

          11.2.4 JB Labs is responsible for having appropriate cleaning
               procedures for product(s) manufactured on dedicated equipment.

          11.2.5 The manufacture of any cytotoxin, penicillin, steroid, or other
               hormone product should not be allowed in a non-segregated area,
               which is used to manufacture Xanodyne products without mutual
               approval of JB Labs and Xanodyne.

     11.3 Equipment, Computer, Facility, and Utilities Qualification

          JB Labs is responsible for the safe and efficient working of all
          equipment, computer, utility, and facility qualification activities
          associated with the Products, including maintenance. Should an issue
          become evident; JB Labs will notify Xanodyne Corporate Quality
          Assurance. JB Labs must make available equipment, computer, facility,
          and utilities qualification data during an Annual or Event MA.

     11.4 Laboratory Qualifications

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

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

          11.4.3 JB Labs is responsible for ensuring all methodology associated
               with the prescription status of the Product(s) is appropriately
               qualified and/or validated. If analytical work is performed at JB
               Labs, then Xanodyne will also provide any existing analytical
               documentation to assist in Methods transfer or Methods
               validation.

          11.4.4 If analytical work is not performed at JB Labs' site, JB Labs
               may elect to perform an audit on vendors to be used for
               analytical testing. Should JB Labs decide to sub-contract out any
               quality control work, prior approval from Xanodyne Corporate
               Quality Assurance will be required.

12.  ANNUAL PRODUCT REVIEW, DRUG LISTING, AND ANNUAL REPORTS

     12.1 Annual Product Review

          JB Labs will perform an annual product review on the Products and will
          issue a report to Xanodyne no later than [**] months after the
          conclusion of an annual manufacturing cycle. This report will be a
          review of any changes in the Manufacturing of the Product in the
          previous year; a summary of lots made, released, and rejected and a
          stability report. Also, control charting or trend analysis of key
          Product parameters will be performed on an annual basis. Any
          abnormalities will be explained in the annual review. This review will
          be conducted in accordance with 21CFR211.180(e) and any other
          Applicable Laws.

     12.2 Drug Listing


                                       15

<PAGE>

          JB Labs is responsible for drug listing as the Manufacturer of the
          Product(s) while Xanodyne is responsible for drug listing as the
          distributor of the Product(s). Xanodyne will provide JB Labs copies of
          all Product labeling including package insert, and NDC code which
          includes labeler code, product code, and packaging code, Xanodyne will
          notify JB Labs of the scheduled Product launch.

     12.3 Annual Reports, IND Updates or Other Regulatory Filings Where
          Applicable

          Xanodyne is responsible for preparing any Annual Report, IND update or
          other regulatory filing as required by Applicable Laws, including 21
          CFR 314.7 (g)(3), 314.81 (b)(2), and/or 601.12 (d), (f)(3). At least
          [**] calendar days before the regulatory due date, Xanodyne may
          request in writing from JB Labs the chemistry, manufacturing and
          controls data required for submission of the filing. JB Labs will
          provide the requested information to Xanodyne within [**] days of
          request.

13.  STORAGE AND SHIPPING

     13.1 Storage

          JB Labs will ensure that during storage of the Product(s) that there
          is no possibility of deterioration, interference, theft, Product
          contamination or admixture with any other materials. Xanodyne
          Corporate Quality Assurance will provide details of any labeling
          requirements and container sealing and integrity requirements.

     13.2 Packing and Labeling for Transit

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

     13.3 Mixing of Product

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

     13.4 Shipment of Product to Xanodyne

          Only approved, finished (unless required otherwise by Xanodyne),
          labeled Products will be shipped by JB Labs to Xanodyne. Any shipment
          of Product from JB Labs, which is unapproved, or under quarantine
          requires prior written consent by Xanodyne's Corporate Quality
          Assurance. This authorization will be on a lot by lot basis.

14   CONTRACTUAL AGREEMENT

     Established at Xanodyne Pharmaceuticals, Inc., One Riverfront Place,
     Newport, Kentucky 41071-4563

     For and on behalf of XANODYNE PHARMACEUTICALS INC:


     S. A. Stamp               CHIEF FINANCIAL OFFICER           /s/ S. A. Stamp
     ---------------------------------------------------------------------------
     NAME                      TITLE                             SIGNATURE


     For and on behalf of J.B. LABORATORIES INC:


     Kelly Devries             General Manager                   /s/ S. A. Stamp
     ---------------------------------------------------------------------------
     NAME                      TITLE                             SIGNATURE


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<PAGE>

                                   APPENDIX I

                                LIST OF PRODUCTS

                                    Products

Duet Tablets 100ct Bottle
Duet Tablets Bulk
Duet Chewable Tablets 90ct Bottle
Stuart Prenatal Tablets 100ct Bottle

DEFINITIONS:

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

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

"NDC" means National Drug Code.


                                       17

<PAGE>

                                   APPENDIX II
                                LIST OF CONTACTS
                           (NAME, PHONE, FAX, E-MAIL)

<TABLE>
<CAPTION>
ISSUE                    XANODYNE PHARMACEUTICALS INC    JB LABORATORIES, INC
-----                    ----------------------------    --------------------
<S>                      <C>                             <C>
Product Release          Contact: Keith Arvin            Contact: Paresh Hansji
                         Phone: (859) 547-3880           Phone : (616) 738-8500
                         Fax: (859) 371-1737             Fax : (616) 738-8709
                         E-mail: karvin@xanodync.com     E-mail: phansji@jblabs.com

Investigations           Contact: Keith Arvin            Contact; JParesh Hansji
                         Phone: (859) 547-3880           Phone : (616) 738-8500
                         Fax: (859) 371-1737             Fax : (616) 738-8709
                         E-mail: karvin@xanodyne.com     E-mail: phansji@jblabs.com

Regulatory Inspections   Contact: Keith Arvin            Contact: Kathy Olgers
                         Phone: (859) 547-3880           Phone : (616) 738-8500
                         Fax: (859) 371-1737             Fax : (616) 738-8709
                         E-mail: karvin@xanodyne.com     E-mail: kolgers@jblabs.com

Stability                Contact: Keith Arvin            Contact: Candi Schneider
                         Phone: (859) 547-3880           Phone : (616) 738-8500
                         Fax:(859)371-1737               Fax : (616) 738-8709
                         E-mail: karvin@xanociyrte.com   E-mail: cschneider@jbiabs.com

Validation               Contact: Keith Arvin            Contact: Michelle Johnson
                         Phone: (859) 547-3880           Phone: (616)738-8500
                         Fax: (859) 371-1737             Fax : (616) 738-8709
                         E-mail: karvin@xanodyne.com     E-mail: nijohnson@jblabs.com

Complaints               Contact: Keith Arvin            Contact: Kathy Olgers
                         Phone: (859) 547-3880           Phone : (616) 738-8500
                         Fax: (859) 371-1737             Fax : (616) 738-8709
                         E-mail: karvin@xanodyne.com     E-mail: kolgers@jblabs.com

Change Management        Contact: Keith Arvin            Contact: Paresh Hansji
                         Phone: (859) 547-3880           Phone : (616) 738-8500
                         Fax: (859) 371-1737             Fax : (616) 738-8709
                         E-mail: karvin@xanodyne.com     E-mail : phansji@jbiabs.com

Audits                   Contact: Keith Arvin            Contact: Kathy Olgers
                         Phone: (859)547-3880            Phone : (616) 738-8500
                         Fax: (859) 371-1737             Fax : (616) 738-8709
                         E-maikkarvin@xanodyne.com       E-mail: kolgers@jblabs.com
</TABLE>


                                       18

<PAGE>

                                  APPENDIX III
                              RELEASE DOCUMENTATION

The release documentation for all Batches will include a Certificate of Analysis
(COA) and a Certificate of Conformance (COC).

A Certificate of Analysis (COA)

This document will list the following:

-    The Product Name

-    The Batch Number

-    The Date of Manufacture

-    All Analytical Test Results and Specifications

-    All Microbiological Test Results

-    Certification that all Specifications have been met.

A Certificate of Conformance (COC)

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

     -    Product name

     -    Lot number

     -    Batch quantity approved

     -    Expiry date

     -    A statement confirming that the batch record conforms to cGMP
          requirements and has been reviewed and approved by JB Labs' Quality
          Assurance.

JB Labs' authorized Quality Assurance personnel will sign the above
certificates.


                                       19