*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED.
ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
 MASTER MANUFACTURING AGREEMENT
 MASTER MANUFACTURING AGREEMENT Agreement Effective Date Medicis Global Services Corporation Medicis WellSpring Pharmaceutical Canada Corp. Supplier Party Parties
 RECITALS
 WHEREAS
 WHEREAS
 NOW THEREFORE
 ARTICLE 1  INTERPRETATION
 1.1 Definitions Schedule 1.1 (Definitions)
 1.2 Sections and Headings
 1.3 Conflicts in Interpretation
 ARTICLE 2  MANUFACTURE AND SUPPLY OF PRODUCTS
 2.1 Manufacture
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2.2 Product and Product Exhibits Exhibit A
 2.3 Components
 2.4 Medicis-Supplied Material
 2.4.1 Delivery
 2.4.2 Damage/Discrepancies
 2.4.3 Risk of Loss
 2.4.4 Title
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2.4.5 Inventory Report of Medicis-Supplied Material
 2.5 Packaging, Labeling and Lot Numbers/Expiration Dates
   2.6 Special Equipment Special Equipment
 2.7 Supplier Relationship Team Supplier Relationship
Team
 2.8 Subcontracting
 2.9 Medicis Responsibilities
 2.10 Consents and Approvals
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ARTICLE 3  ORDERS, DELIVERY AND CAPACITY
 3.1 Forecast Forecast Firm Order
 3.2 Written Orders
 3.3 Batch Acceptance/Release
  Release Information
 Section 3.4
 3.4 Non-Conforming Orders
 3.4.1 Notification Latent Defect Section 3.4.3 Section 3.3(c)
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3.4.2 Shortages Acceptable Yield Medicis-Supplied Material
Reimbursement Value
 3.4.3 Third-Party Testing Disputed Product
 3.5 Capacity
   Exhibit C
 ARTICLE 4  QUALITY CONTROL AND COMPLIANCE
 4.1 Quality Agreement Exhibit B
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4.2 Quality Control and Assurance
 (a)
    
    Supplier shall perform the Services and perform quality assurance and quality
control testing in accordance with: (i) the applicable NDA and/or regulatory approval
including, without limitation, the detailed chemistry manufacturing control section
thereof; (ii) the applicable Specifications; (iii) the cGMPs; (iv) all other Applicable
Laws; and (v) the mutually approved batch record.(b)
    
    Supplier shall ensure the Products delivered under this Agreement will not be
adulterated or misbranded by Supplier under the Federal Food, Drug and Cosmetic Act
(Act), or under any other Applicable Laws.(c)
    
    Supplier shall perform such quality control and quality assurance testing as is
reasonably required to ensure that the Products comply with all of the Manufacturing
Requirements.
 4.3 Product Change
 4.3.1 Change Control
 4.3.2 Change in Specifications
   4.4 Validation and Testing
    4.5 Product and Process Qualification
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4.6 Safety
 4.6.1 Material Safety Data Sheet
 4.6.2 Product Safety
 4.6.3 Waste Disposal
 4.7 Personnel Training/Qualification
 4.8 Customer Questions, Complaints and Product Inquiries
  Inquiry
 4.9 Product Returns
 4.10 Product Recalls
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4.11 Retention and Record Keeping
 CFR
  4.12 Regulatory Matters
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Annual Product Review
 Inspection Rights
 (a)
    
    Medicis shall have the right to conduct *** Manufacturing Audit (as defined
below) *** according to the terms specified in this Section 4.14 hereof (such annual
Manufacturing Audit to be hereinafter referred to as an Annual MA).(b)
    
    In addition to the Annual MA, in the event that (i) Supplier is conducting
start-up activities, (ii) Supplier receives a FORM FDA 483 or a Warning Letter from
the FDA, Health Canada or any foreign equivalent outside Canada or the United States
relating to the manufacture, packaging or labeling of the Products by Supplier, (iii)
Medicis has rejected a batch of Product where it has been agreed or determined that
such Product failed to meet the Specifications or GMPs, (iv) Medicis or Supplier has
received a series of complaints (i.e., three or more complaints on at least two lots of
a Product) from third parties within any calendar year relating to the manufacture of
the Product, or (v) if there is a quality issue related to the Product, Medicis shall
have the right to conduct additional Manufacturing Audits according to the terms
specified in subsection (d) below (such additional Manufacturing Audit or Audits to be
hereinafter referred to as an Incident MA).(c)
    
    It is agreed that Medicis may arrange routine observational visits to
Suppliers Facility of not longer than *** and in no greater frequency than *** in any
***.(d)
    
    For purposes of this Agreement, the term Manufacturing Audit shall mean an
audit of Suppliers Facility by no more than *** Medicis employees and/or agents for
purposes of reviewing Suppliers procedures and processes used in manufacturing and/or
packaging the Products. Any such agents shall be qualified to conduct manufacturing
audits, shall comply with all Suppliers facility rules regarding safety and security
notified by Supplier to Medicis and its employees and/or agents and shall execute a
written agreement to maintain in confidence all information obtained during the course
of any such audit except for disclosure to Medicis subject to the terms hereof. Each
Manufacturing Audit shall be conducted during Suppliers normal business hours and upon
at *** prior written notice to Supplier in the case of an Annual MA, or *** notice to
Supplier in the case of an Incident MA. In no event shall a Manufacturing Audit exceed
*** in duration, and in all cases Medicis shall ensure that its employees or agents
will conduct each Manufacturing Audit, to the extent reasonably possible, so as not to
interfere with the normal and ordinary operation of Suppliers Facility. During a
Manufacturing Audit, upon Mediciss request, Supplier shall make available for
Mediciss review and inspection all equipment and facilities used in or in relation to
the manufacture and/or packaging of the Products, records and support documents (i.e.,
manufacturing and analytical) with respect to each batch of
 Medicis / Wellspring  Master Manufacturing Agreement
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(e)
    
    In the event Medicis provides Supplier with a written audit report, within
thirty (30) days of receipt of this audit report, Supplier shall provide Medicis in
writing a proposed action plan subject to Mediciss prior written approval to address
the issues described by Medicis in the report.
 4.15 Regulatory Inspections
 4.16 Compliance with Section 6032 of Deficit Reduction Act of 2005 Medicis Employee Education Policy Concerning the Prevention and Detection of Fraud,
Waste, and Abuse in Government Health Care Programs: Compliance Policy Pursuant to the Deficit
Reduction Act of 2005 Deficit Reduction Act Compliance Policy Applicable Agents Federal and State Statutes and Administrative Remedies Related to Preventing and Detecting Fraud,
Waste, and Abuse in Government Health Care Programs
 ARTICLE 5  PRICING AND PAYMENT TERMS
 5.1 General Article 5
 5.2 Price Adjustments
 (a)
    
    ***(b)
    
    ***(c)
    
    ***
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5.3 Delayed Shipment Discount Grace Period Section 13.6 Section 7.2
 5.4 Invoices
 
 5.5 Payment
 ARTICLE 6  REPRESENTATIONS AND WARRANTIES
 6.1 Authority
 6.2 Not Debarred
 6.3 Capacity; Personnel Section 4.7
 6.4 Title
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6.5 Shelf Life
 6.6 Compliance with Laws
    6.7 Components
 6.8 Performance of Obligations
 6.9 Intellectual Property
 6.10 Additional Covenants of Medicis
 (a)
    
    provide all information in Mediciss possession or within its control that is
necessary for Supplier to Manufacture the Products in accordance with the
Specifications and all applicable laws, including GMPs; and
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(b)
    
    make its employees available on a timely basis to respond to questions
concerning such information.
 6.11 Disclaimers
 (a)
    
    EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLE 6, NEITHER PARTY MAKES ANY
REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW,
BY STATUTE OR OTHERWISE, AND BOTH PARTIES EXPRESSLY DISCLAIM ANY AND ALL IMPLIED OR
STATUTORY WARRANTIES, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY,
WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR WARRANTY OF NON-INFRINGEMENT.(b)
    
    IN ADDITION, SUPPLIER MAKES NO WARRANTY REGARDING, AND SHALL HAVE NO LIABILITY
WITH RESPECT TO THE CONDUCT OF MEDICIS OR ANY THIRD PARTY OTHER THAN SUPPLIERS
AFFILIATES, SUBCONTRACTORS AND REPRESENTATIVES.(c)
    
    SUPPLIER WILL NOT BE RESPONSIBLE FOR DELAYS ARISING FROM THE FAILURE OF MEDICIS
TO PROVIDE TO SUPPLIER THOSE MATERIALS, INFORMATION AND CO-OPERATION IN A TIMELY MANNER
THAT SUPPLIER ADVISES MEDICIS IN WRITING ARE REQUIRED IN ORDER FOR SUPPLIER TO PERFORM
ITS OBLIGATIONS ON A TIMELY BASIS INCLUDING THE DATES BY WHICH SUPPLIER REQUIRES SUCH
MATERIALS, INFORMATION AND CO-OPERATION. SUPPLIER WILL USE COMMERCIALLY REASONABLE
EFFORTS TO MEET THE AGREED UPON TIMELINES AND SPECIFICATIONS. SHOULD THE OCCASION
ARISE, SUPPLIER WILL ATTEMPT TO LIMIT THE EFFECT OF SUCH DELAYS AND WILL INFORM MEDICIS
OF THE DELAYS AND THEIR IMPACT TO THE TIMELINE.
 6.12 Application/Survival
 ARTICLE 7  TERM, RENEWAL AND TERMINATION
 7.1 Term Initial Term Renewal Term Term Section 7.2
 7.2 Termination
 (a)
    
    By mutual agreement of the Parties.(b)
    
    Upon failure of either Party to remedy its material breach of any of the
obligations or provisions of this Agreement within *** following receipt of written
notice of said breach, the aggrieved Party shall have the right to terminate this
Agreement immediately by written notice.(c)
    
    Either Party at its sole option may immediately terminate this Agreement upon
written notice, but without prior advance notice, to the other Party in the event that
(i) the other Party is declared insolvent or bankrupt by a court of competent
jurisdiction; (ii) a voluntary petition of bankruptcy
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(d)
    
    By Medicis upon the occurrence of the following and Supplier fails to cure
within *** after receipt of written notice from Medicis identifying the breach. Such
termination shall be without liability to Medicis except for Product or Services
previously delivered and accepted.
 (i)
    
    Supplier fails to make delivery of Products or Services on or before the
delivery date specified on the Product Exhibit, in accordance with the terms of
Section 5.3;(ii)
    
    Supplier materially breaches any material term, provisions, warranty,
representation obligation or condition of this Agreement;(iii)
    
    Supplier, due to its negligence or willful misconduct and excluding Force
Majeure events, fails to make progress as to endanger performance of the applicable
Product Exhibit in accordance with its terms; or(iv)
    
    Supplier ceases to conduct its operations in the normal course of business
(including inability to meet its obligations as they mature).
 (e)
    
    By Supplier upon:
 (i)
    
    a material breach by Medicis of Mediciss obligations of confidentiality under
Article 8of this Agreement if Medicis fails to cure such breach within *** after
receipt of written notice from the Supplier identifying the breach; or(ii)
    
    non-payment of an undisputed amount invoiced by Supplier to Medicis if Medicis
fails to cure such breach within *** after receipt of written notice from Supplier
identifying the non-payment and Suppliers intent to terminate this Agreement
pursuant to this Section.
    7.3 Rights and Obligations Upon Termination
  Section 4.11
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(i)
    
    ***(ii)
    
    ***(iii)
    
    ***
   7.4 Survival Articles 1, 6 8 13 Sections 4.8, 4.9,
4.10, 4.11 7.3
 ARTICLE 8  CONFIDENTIALITY
 8.1 Medicis Confidential Information Medicis Confidential Information
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8.2 Supplier Confidential Information Supplier Confidential Information
 8.3 Permitted Disclosures Sections 8.1 8.2 Section
8.2
 8.4 Exceptions Sections 8.1 8.2
 ARTICLE 9  PROPRIETARY RIGHTS
 9.1 License to Manufacture Product
 9.2 NDAs
 9.3 Intellectual Property
 (a)
    
    Medicis shall retain ownership of all information, documents, and materials that Medicis
provides to Supplier in connection with the performance of this Agreement and all Product
Exhibits. Further,
 Medicis / Wellspring  Master Manufacturing Agreement
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Medicis shall have the right to obtain and use copies of all reports, documents and other
tangible materials generated by Supplier that are related to the Product as part of the
Services rendered under this Agreement.(b)
    
    Medicis shall own, and Supplier hereby assigns to Medicis, all right, title and interest
in and to any Intellectual Property developed by Supplier in the course of Supplier
performing the Services under this Agreement that arise from, are based on, or relate to
Suppliers use of Confidential Information of Medicis or its Affiliates or the Product,
including without limitation, the composition or formulation of, apparatus, system,
processes or method of manufacture for or method of use of Product, any patents, trademarks,
service marks, trade names, slogans, logos, copyrights, trade dress, designs, moral rights,
know-how and goodwill associated with, related to or arises from Product and any
improvements, enhancements, modifications, changes or derivative works thereof
(collectively, the Medicis Owned Developments); provided, however, that Medicis Owned
Developments shall not include Supplier Owned Developments. As used herein, Supplier Owned
Developments means Intellectual Property that ***. With respect to Supplier Owned
Developments, Supplier hereby grants to Medicis a non-exclusive, irrevocable, royalty-free
license, with the right to sublicense, to use such Supplier Owned Developments in connection
with Product. Supplier shall have no rights of ownership or use in any Intellectual
Property owned by Medicis or any Medicis Owned Developments, including without limitation
the Product and related technology. Upon completion or termination of the Services under
the applicable Product Exhibit, Supplier shall disclose to Medicis all Medicis Owned
Developments developed as part of such Services.
 9.4 Trademarks Product Trademark
 9.5 Settlement
 ARTICLE 10  INDEMNITY
 10.1 Indemnification by Medicis Supplier Indemnified Parties Claims
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10.2 Indemnification by Supplier Medicis Indemnified Parties
 10.3 Procedures for Indemnification Sections 10.1 10.2 Sections 10.1 10.2 Claim Section 10.3 Section 10.1 Section 10.2 Indemnified Party Indemnifying Party
 ARTICLE 11  LIMITATION OF LIABILITY
 11.1 No Indirect Damages Section 11.3
 11.2 Direct Damages . Section 11.3
 11.3 Exceptions Sections 11.1 11.2 Article 10 Section 4.10
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ARTICLE 12  DISPUTE RESOLUTION
 12.1 Senior Executives
 12.2 Voluntary, Non-Binding Mediation
 12.3 Continued Performance; No Tolling of Cure Periods
 12.4
 12.5 Equitable Relief
 ARTICLE 13  MISCELLANEOUS
 13.1 Permits
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13.2 Insurance
 13.2.1 Property Damage
 13.2.2 Liability
 13.2.3 Evidence of Coverage; Cancellation
 13.3 Notices
  
   
 13.4 Publicity
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13.5 Relationship Between Parties
 13.6 Force Majeure
 Force Majeure
 Competing Products
   13.7 Binding, Nature, Assignments
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13.8 Costs and Attorneys Fees
 13.9 No Waivers
 13.10 Severability
 13.11 Neither Party Considered Drafter
 13.12 Cumulative Remedies
 13.13 Controlling Law, Jurisdiction and Venue
 13.14 Amendment
 13.15 Counterparts
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13.16 Entire Understanding
  MEDICIS GLOBAL SERVICES CORPORATION
    
    WELLSPRING PHARMACEUTICAL
CANADA CORP.By:
    
    
    
    By:Name: Mark A. Prygocki, Sr.
    
    
    
    Name:Title: CFO and Treasurer
    
    
    
    Title:
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APPENDIX 1
 DEVELOPMENT, TECHNICAL TRANSFER AND OTHER SERVICES
 1. General
 1.1 Performance Milestones Section 1.3 Deadline Default Notice Default Period Section 1.2
 1.2 Remedies for Defective Services
 1.
    
    Except as otherwise set forth in Section 1.3, in the event that Suppliers performance of, or
failure to perform, the Other Services (excluding, but not limited to, Force Majeure, failure
to perform due to sanctions, warnings, orders or penalties imposed by any Governmental Bodies)
results in (a) the Services not being performed in accordance with the Product Exhibit,
including Suppliers failure to meet any applicable Deadlines, (b) the Services and/or
deliverables having to be re-performed to obtain the desired result, and/or (c) the
deliverables containing errors or Defects (subsections (a), (b) and (c) are individually and
collectively referred to as the Defective Services), then in addition to any other rights or
remedies that may be available to Medicis as provided in this Agreement and/or the applicable
Product Exhibit or at law or in equity, Supplier shall, at no additional cost to Medicis and
at Mediciss option (x) repeat the Defective Services until such time as Services have been
provided in accordance with the applicable Product Exhibit; or (y) refund to Medicis all
amounts paid by Medicis to Supplier in connection with the Defective Services and any affected
Services.2.
    
    In addition to each of the foregoing options, if Supplier fails to meet a Deadline in
accordance with Section 1.1above, Medicis shall have the right, to the fullest extent
permitted by law, hold back any fees owed and not yet paid to Supplier pursuant to the Project
Exhibit (the Hold Back Amount). Medicis agrees to notify Supplier of its decision to
exercise its right of hold back, provided, that the failure to give such notice shall not
affect the validity of any such refusal to make payments. If, however, Supplier performs its
obligations within *** of the date of the expiration of the Default Period, Medicis shall
release to Supplier the entire Holdback Amount. If Supplier fails to perform its obligations
within *** following the date of the expiration of the Default Period, Medicis shall have the
right to retain the entire Hold Back Amount.
 1.3 Exceptions to Remedies for Defective Services Third Party Subcontractor
 1.4 Change in Scope of Services
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1.5 Progress Reports
 1.6 Project Managers
 1.7 DISCLAIMER . WITH RESPECT TO FORMULATION DEVELOPMENT SERVICES ONLY, DUE TO THE NATURE
OF THE WORK INVOLVED, RESULTS OF THE DEVELOPMENT CANNOT BE GUARANTEED, HOWEVER, SUPPLIER WILL USE
GOOD FAITH AND COMMERCIALLY REASONABLE EFFORTS IN PERFORMING THE WORK OUTLINED IN THE APPLICABLE
PRODUCT EXHIBITS THAT INCLUDE DEVELOPMENT SERVICES TO ACHIEVE MEDICISS OBJECTIVE. MEDICIS
ACKNOWLEDGES THAT THE RESULTS OF SUCH DEVELOPMENT SERVICES ARE INHERENTLY UNCERTAIN AND THAT
ACCORDINGLY, THERE CAN BE NO ASSURANCE, REPRESENTATION OR WARRANTY BY SUPPLIER THAT THE SERVICES
PROVIDED THEREUNDER CAN OR WILL RESULT IN A FORMULATION THAT WILL RECEIVE THE REQUIRED APPROVAL(S)
FROM THE FDA, OR OTHER REGULATORY AGENCY OR AUTHORITY.
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SCHEDULE 1.1  DEFINITIONS
  Affiliate
 Applicable Laws
 Business Day
 Calendar Quarter Quarterly
 cGMPs
 Components
 Defect Defective
 Deficiency Notice
 Facility
 Fees
 FDA
 Intellectual Property
 Inventory
 Labeling
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Manufacture
 Manufacturing Requirements
 Medicis Patents
 Medicis-Supplied Material
 Medicis-Supplied Material Specifications
 Medicis Technical Information
 (i)
    
    a detailed description of the Product and any Medicis-Supplied Material,
including their respective physical and chemical characteristics and stability;(ii)
    
    the Labeling;(iii)
    
    shipping and storage requirements; and(iv)
    
    all environmental, health and safety information relating to the Product
including material safety data sheets, incident reports, risk analyses, health
concerns, preventative measures and procedures for waste disposal, all as updated,
amended and revised from time to time by Medicis.
 Minimum Yield
 NDA
 Other Services
 Person
 Price
 Product
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Product Exhibit Section 2.3
 Quality Agreement Exhibit B
 Reimbursement Value
 Representatives
 Services
 Specifications
 Sublicensee
 Supplier Technical Information
 Third Party
 United States
 Yield
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EXHIBIT A  PRODUCT EXHIBIT # [__]
 PRODUCT EXHIBIT #[___] Product Exhibit  Effective Date Medicis Global Services Corporation Medicis WellSpring Pharmaceutical Canada Corp. Supplier Party Parties
 Agreement
 1.
    
    Medicis-Supplied Material. The Medicis-Supplied Material is described on Attachment
1to this Product Exhibit.2.
    
    Product Specifications. The Product Specifications are described on Attachment 2to
this Product Exhibit.3.
    
    Medicis Obligations. Medicis shall provide the following to Supplier in accordance with
the following time periods:
 i.
    
    At least  (___) weeks prior to the Commencement Date, any
Labeling to be printed by Supplier on the Finished Product, all of which shall be
in conformity with the regulations of the United States Food and Drug
Administration and any other applicable federal, state or local Governmental Bodyii.
    
    At least  (___) weeks prior to the Commencement Date, any
Medicis-Supplied Materials;iii.
    
    At least  (___) weeks prior to the Commencement Date, the
lot and expiry information of the Products;iv.
    
    At least  (___) weeks prior the Commencement Date, the
Medicis-Supplied Material Specifications;v.
    
    At least  (___) weeks prior the Commencement Date, the
Medicis Technical Information; andvi.
    
    At least  (___) weeks prior the Commencement Date, the
Specifications.
 4.
    
    Start-Up Activities. Start-Up Activities means those activities required by the
Medicis or Supplier that are necessary to commence the Manufacture of Products as set forth on
Attachment 3to this Product Exhibit.5.
    
    Minimum Batch Size. The minimum batch size is  ().6.
    
    Minimum Yield. Minimum Yield shall mean the yield set forth in writing by the
Supplier Relationship
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 Page
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7.
    
    NDA. NDA shall mean the New Drug Application Number  and any subsequent
submissions, supplements or amendments thereto.8.
    
    Product. Product shall mean various presentations of the finished product
containing Medicis-Supplied Material and as described in the Specifications.9.
    
    Product Specifications. The Specifications for Manufacturing and testing the Product
are set forth on Attachment 2to this Product Exhibit.10.
    
    Shelf Life and Storage Requirements. Product shipped to Medicis or other location of
Mediciss designation shall have a shelf life of at least  () months from the date
of shipment. The storage requirements for the Product are set forth on Attachment 4to this
Product Exhibit.11.
    
    Price Schedule.12.
    
    Minimum Order Quantities.
 MEDICIS GLOBAL SERVICES CORPORATION
    
    WELLSPRING PHARMACEUTICAL
CANADA CORP.By:
    
    
    
    By:Name:
    
    
    
    Name:Title:
    
    
    
    Title:
 Exhibit A  Product Exhibit #[_]  Medicis/Wellspring Master manufacturing Agreement
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ATTACHMENT 1
 MEDICIS-SUPPLIED MATERIAL SPECIFICATIONS
 [TO BE PROVIDED]
 Attachment
1 to Product Exhibit #[_]  Medicis / Wellspring Master manufacturing Agreement
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ATTACHMENT 2
 PRODUCT SPECIFICATIONS
 [TO BE PROVIDED]
 Attachment 2 to Product Exhibit #[___]  Medicis / Wellspring Master Manufacturing Agreement
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ATTACHMENT 3
 START-UP ACTIVITIES
 [TO BE PROVIDED]
 Attachment 3 to Product Exhibit #[___]  Medicis / Wellspring Master Manufacturing Agreement
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ATTACHMENT 4
 SHELF LIFE AND STORAGE REQUIREMENTS
 [TO BE PROVIDED]
 Attachment 4 to Product Exhibit #[___]  Medicis / Wellspring Master Manufacturing Agreement
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EXHIBIT B:
 QUALITY AGREEMENT (QA)
 [TO BE PROVIDED BY MEDICIS]
 Exhibit B  Medicis / Wellspring Master Manufacturing Agreement
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EXHIBIT B: QUALITY AGREEMENT (QA)
 Overview
 WellSpring Pharmaceutical Canada Corp Medicis Global Services
Corporation
  Term of Quality Agreement
  Revisions to Agreement
  Communication
  Responsibilities
 X o X
 1




---



##### 



AREA OF RESPONSIBILITY  GENERAL
 WPCC
    
    MEDICIS1.
    
    
    Provide Specifications to Manufacture Product in compliance with regulations,
FDA guidelines, industry standards and product processing documents.
    
    ***
    
    ***2.
    
    
    Manufacture Product in strict adherence to the approved Specifications,
Applicable Laws, applicable site SOPs, cGMPs and NDA/ANDA submissions.
    
    ***
    
    ***3.
    
    
    As per the Generic Drug Enforcement Act of 1992, is not debarred nor shall
employ or use the services of any individual who is debarred.
    
    ***
    
    ***4.
    
    
    Not to subcontract any work, including raw material, bulk and/or finished
Product laboratory testing, to any Third Party, other than those listed in Appendix
III, without prior written approval from *** in accordance with Section 13.7(a) of
the MMA.
    
    ***
    
    ***5.
    
    
    Provide tabulated information and a cGMP annual product review report in
compliance with 21 CFR 211.180(e).
    
    ***
    
    ***6.
    
    
    Provide to *** required information for annual reports and other documents to
support Medicis regulatory filings and commitments upon request including
qualification documentation.
    
    ***
    
    ***7.
    
    
    Notify *** within one (1) Business Day of receipt of an governmental or
regulatory inquiry, communication, audit or inspection of the Services, Facilities,
or Manufacturing processes relating to a Product.
    
    ***
    
    ***8.
    
    
    Responsible for the registration of the Drug Establishment and maintaining the
site manufacturing license for the production of the Product.
    
    ***
    
    ***9.
    
    
    Review and approve responses to regulatory authorities directly related to the
Product prior to submission to the regulatory authority and *** shall cooperate
with *** in accordance with the MMA, including without limitation Section 4.12].
    
    ***
    
    ***
 AREA OF RESPONSIBILITY  QUALITY SYSTEMS
 WPCC
    
    MEDICIS10.
    
    
    Notify ***as soon as possible and not longer than one (1) business day of
areas of concern identified during the review of any Medicis product documents,
requests for Medicis product samples or notice of inspections for a Medicis
product.
    
    ***
    
    ***11.
    
    
    Liaise with regulatory authorities for approval and ongoing maintenance of
submissions as it pertains to the product .
    
    ***
    
    ***12.
    
    
    Perform services, quality assurance and quality control testing in accordance
with applicable nda, regulatory approvals, the batch records, all applicable laws,
specifications, and cgmps.
    
    ***
    
    ***
 QUALITY SYSTEMS  CHANGE CONTROL
 WPCC
    
    MEDICIS13.
    
    
    Notification of all changes to product including, process and controls (e.g.
Changes in raw materials/packaging materials specifications, test methods,
manufacturing processes, product specifications, master batch records etc.) In
accordance to the provisions of the mma including without limitation section 4.3.1.
    
    ***
    
    ***14.
    
    
    Approve any changes impacting regulatory submissions, specifications and/or
impacting the identity, strength, quality, purity, potency, safety, efficacy and
availability of the product.
    
    ***
    
    ***15.
    
    
    Provide regulatory input on timing of changes for appropriate products.
    
    ***
    
    ***16.
    
    
    Update relevant documents affected by changes described in section 12 of this
quality agreement.
    
    ***
    
    ***17.
    
    
    Approve relevant documents provided under section 15 of this quality agreement.
    
    ***
    
    ***18.
    
    
    Provide copies of approved, implemented documents within 15 days of approval.
    
    ***
    
    ***
 2




---



##### 



QUALITY SYSTEMS  DOCUMENTATION
    
    WPCC
    
    MEDICIS19.
    
    
    Create master batch record (includes formulation, filling and packaging) based
on Medicis technical information.
    
    ***
    
    ***20.
    
    
    Approve master batch record.
    
    ***
    
    ***21.
    
    
    Generate, issue and execute accurate copies of the master batch record.
    
    ***
    
    ***22.
    
    
    Create raw material, product, packaging and testing specifications based on
Medicis technical information.
    
    ***
    
    ***23.
    
    
    Approve raw material, product, packaging and testing specifications.
    
    ***
    
    ***24.
    
    
    Maintain records and evidence of the testing of components for ***after the
components are last used in the manufacture of the product
    
    ***
    
    ***25.
    
    
    Retain originals of non-validation and non-developmental batch documentation
and representative samples from each product lot as required by the cfr or in any
event for at least ***past the expiry of the product.
    
    ***
    
    ***26.
    
    
    Maintain executed batch records for validation and developmental batches for
the life of the product and product line. Provide copies to ***.
    
    ***
    
    ***27.
    
    
    Provide copies of entire batch records to ***for their files, submissions or
for investigative purposes as requested.
    
    ***
    
    ***28.
    
    
    Submit field alert reports.
    
    ***
    
    ***
 QUALITY SYSTEMS  DEVIATIONS AND INVESTIGATIONS
    
    WPCC
    
    MEDICIS29.
    
    
    Notify ***of any major deviation impacting the quality, strength, purity,
safety and compliance of a product lot or methods used for the manufacture, of a
product within ***of its occurrence.
    
    ***
    
    ***30.
    
    
    Conduct investigation of major and minor deviations.
    
    ***
    
    ***31.
    
    
    Create deviation/investigation report for major and minor deviations.
    
    ***
    
    ***32.
    
    
    Review and approve the final deviation/investigation report for major
deviations.
    
    ***
    
    ***33.
    
    
    Provide copies of final major and minor deviation/investigation report with
batch documentation.
    
    ***
    
    ***
 QUALITY SYSTEMS - COMMERCIAL PRODUCT RELEASE & RECALL
    
    WPCC
    
    MEDICIS34.
    
    
    No less than ***prior to the requested shipment date, provide ***a
certificate of conformance, certificate of analysis, copies of labeling, applicable
sections of the batch records or upon ***request the complete batch record, copy
of investigations and deviations for each bulk and finished product in accordance
with the mma including without limitation section 3.3(b).
    
    ***
    
    ***35.
    
    
    All deviations and oos investigations must be closed prior to batch release and
a copy of the closed investigation included in the batch record. Long-term capa
items may remain open with agreement from Medicis.
    
    ***
    
    ***36.
    
    
    Release of bulk product for filling and packaging.
    
    ***
    
    ***37.
    
    
    Release of finished product for commercial distribution.
    
    ***
    
    ***38.
    
    
    Initiate product recall.
    
    ***
    
    ***39.
    
    
    Participate in product recall investigations at ***request.
    
    ***
    
    ***
 QUALITY SYSTEMS - LAB TESTING
    
    WPCC
    
    MEDICIS40.
    
    
    Supply/develop and validate analytical test methods for finished product and
raw materials if non-compendial.
    
    ***
    
    ***41.
    
    
    Verify compendial methods as per internal sops.
    
    ***
    
    ***42.
    
    
    Coordinate all bulk and finished product testing activities, including
stability.
    
    ***
    
    ***43.
    
    
    Develop test method transfer protocols.
    
    ***
    
    ***44.
    
    
    Test method transfer protocol execution  raw materials, bulk & finished
product analytical methodology.
    
    ***
    
    ***45.
    
    
    Review & approve test method transfer protocols, data and final report for raw
materials, bulk and finished product.
    
    ***
    
    ***
 3




---



##### 



QUALITY SYSTEMS  OUT OF SPECIFICATIONS (OOS) INVESTIGATIONS
    
    WPCC
    
    MEDICIS46.
    
    
    Out of specification investigation provide report to ***.
    
    ***
    
    ***47.
    
    
    Notify ***in writing within ***of a batch failure, deviation, or within ***
of a confirmed oos test result for commercial release testing. It is understood by
both parties that ***may complete an internal laboratory investigation without
requiring a ***quality signature, but shall place a copy of the completed report
in the batch record as part of ***final batch record review and disposition prior
to release.
    
    ***
    
    ***48.
    
    
    Review and approve any confirmed oos or non-conformance reports (ncr).
    
    ***
    
    ***
 QUALITY SYSTEMS - STABILITY PROGRAM
    
    WPCC
    
    MEDICIS49.
    
    
    Responsibility for stability programs complying with applicable regulatory
guidance & product filings, including the suitability of the expiry period to the
formulation and packaging system.
    
    ***
    
    ***50.
    
    
    Assign expiration dating.
    
    ***
    
    ***51.
    
    
    Designate which lots are to be placed on stability.
    
    ***
    
    ***52.
    
    
    Provide validated stability indicating assay.
    
    ***
    
    ***53.
    
    
    Generate stability protocol.
    
    ***
    
    ***54.
    
    
    Approve stability protocol.
    
    ***
    
    ***55.
    
    
    Execute stability protocol testing.
    
    ***
    
    ***56.
    
    
    Notify ***of any stability failure for product within ***of discovery.
    
    ***
    
    ***57.
    
    
    Provide stability data reports within ***of completion of testing.
    
    ***
    
    ***58.
    
    
    All missed stability test stations will be properly investigated and
documented. ***will be notified of missed test stations. (provide copy of
deviation investigation)
    
    ***
    
    ***
 QUALITY SYSTEMS - RESERVE SAMPLES
    
    WPCC
    
    MEDICIS59.
    
    
    Retain reserve samples of finished product for ***beyond product expiry.
    
    ***
    
    ***60.
    
    
    Perform annual reserve sample inspection as per 21cfr 211.170. Provide reports
at time of annual product review per product.
    
    ***
    
    ***
 QUALITY SYSTEM  CUSTOMER COMPLAINTS INVESTIGATION
    
    WPCC
    
    MEDICIS61.
    
    
    Complete an investigation of a complaint within ***of receipt of a request by
***.
    
    ***
    
    ***62.
    
    
    Investigate complaints related to the manufacture of the products.
    
    ***
    
    ***63.
    
    
    Investigate complaints related to the effectiveness of product.
    
    ***
    
    ***64.
    
    
    Investigate complaints related to the adverse effects of the product.
    
    ***
    
    ***65.
    
    
    Reply to complainant.
    
    ***
    
    ***
 QUALITY SYSTEMS  AUDITS
    
    WPCC
    
    MEDICIS66.
    
    
    Permit audits of all relevant premises, processes, procedures and documentation
by ***or its representatives and notify ***of any inspection by regulatory
authorities in accordance with the provisions in the mma.
    
    ***
    
    ***67.
    
    
    Audit api manufacturer.
    
    ***
    
    ***68.
    
    
    Approval of component manufacturers.
    
    ***
    
    ***
 AREA OF RESPONSIBILITY-MANUFACTURING
 MANUFACTURING  RAW MATERIALS
    
    WPCC
    
    MEDICIS69.
    
    
    Establish & approve specifications for the raw materials
    
    ***
    
    ***70.
    
    
    Prepare documents for change control for any matters related to the raw
materials.
    
    ***
    
    ***71.
    
    
    Select vendor for components.
    
    ***
    
    ***72.
    
    
    Approve vendor for components.
    
    ***
    
    ***73.
    
    
    Procurement of components.
    
    ***
    
    ***74.
    
    
    Procurement of API.
    
    ***
    
    ***75.
    
    
    Inspection, testing documents, testing & release/rejection of components.
    
    ***
    
    ***76.
    
    
    Inspection, testing documents, testing & release/rejection of API.
    
    ***
    
    ***77.
    
    
    Retention of components raw material samples for one (1) year beyond product
expiry.
    
    ***
    
    ***78.
    
    
    Retention of Api Raw material samples in accordance with 21 C.F.R. §211.170.
    
    ***
    
    ***
 4




---



##### 



MANUFACTURING - PACKAGING MATERIALS
    
    WPCC
    
    MEDICIS79.
    
    
    Artwork development, review and approval.
    
    ***
    
    ***80.
    
    
    Establish and approve packaging specifications.
    
    ***
    
    ***81.
    
    
    Prepare packaging specification documentation for review through change control.
    
    ***
    
    ***82.
    
    
    Vendor selection.
    
    ***
    
    ***83.
    
    
    Vendor approval.
    
    ***
    
    ***84.
    
    
    Packaging materials procurement.
    
    ***
    
    ***85.
    
    
    Inspection, inspection documents, testing & release/rejection of packaging
materials.
    
    ***
    
    ***86.
    
    
    Notify ***of material rejections of packaging materials for ***products.
    
    ***
    
    ***
 MANUFACTURING- BULK FORMULATION
    
    WPCC
    
    MEDICIS87.
    
    
    Provide the specifications for product.
    
    ***
    
    ***88.
    
    
    Prepare master manufacturing batch record.
    
    ***
    
    ***89.
    
    
    Approve master manufacturing batch record.
    
    ***
    
    ***90.
    
    
    Manufacture bulk products per approved specifications.
    
    ***
    
    ***91.
    
    
    Control & review all process deviations.
    
    ***
    
    ***92.
    
    
    Review and approve major and minor process deviations.
    
    ***
    
    ***93.
    
    
    Establish & approve bulk product specifications.
    
    ***
    
    ***94.
    
    
    Prepare change control bulk product specifications documentation.
    
    ***
    
    ***95.
    
    
    Provide bulk product sampling plan.
    
    ***
    
    ***96.
    
    
    Bulk product sampling.
    
    ***
    
    ***97.
    
    
    Bulk product testing as per approved specification.
    
    ***
    
    ***98.
    
    
    Review of manufacturing batch documents.
    
    ***
    
    ***99.
    
    
    Release/rejection of bulk product for internal filling and packaging.
    
    ***
    
    ***100.
    
    
    Approval of bulk product rejections.
    
    ***
    
    ***
 MANUFACTURING  FILLING & PACKAGING
    
    WPCC
    
    MEDICIS101.
    
    
    Master packaging work order preparation.
    
    ***
    
    ***102.
    
    
    Master packaging work order approval.
    
    ***
    
    ***103.
    
    
    Expiry date determination.
    
    ***
    
    ***104.
    
    
    Application of lot number and expiry date to products.
    
    ***
    
    ***105.
    
    
    Filling and packaging of released bulk products per approved packaging work
orders.
    
    ***
    
    ***106.
    
    
    Packaging in-process line inspection and sampling.
    
    ***
    
    ***107.
    
    
    Establish & approve finished product specifications.
    
    ***
    
    ***108.
    
    
    Prepare finished product specifications documents.
    
    ***
    
    ***109.
    
    
    Provide finished product sampling plan.
    
    ***
    
    ***110.
    
    
    Finished product sampling.
    
    ***
    
    ***111.
    
    
    Finished product testing as per approved specification.
    
    ***
    
    ***112.
    
    
    Review of packaging batch documents.
    
    ***
    
    ***
 MANUFACTURING  VALIDATION
    
    WPCC
    
    MEDICIS113.
    
    
    Facility validation.
    
    ***
    
    ***114.
    
    
    Consult with ***regarding selection of equipment used in the manufacture of
medicis products.
    
    ***
    
    ***115.
    
    
    Approve of changes in equipment used in the manufacture of medicis products.
    
    ***
    
    ***116.
    
    
    Manufacturing equipment validation (iq, oq, pq).
    
    ***
    
    ***117.
    
    
    Preparation and approval of cleaning procedures.
    
    ***
    
    ***118.
    
    
    Cleaning validation.
    
    ***
    
    ***119.
    
    
    Review and approve validation protocols and summary reports of validation
activities relating to the product.
    
    ***
    
    ***120.
    
    
    Confirm that validation protocol complies with product filings.
    
    ***
    
    ***121.
    
    
    Develop manufacturing protocol.
    
    ***
    
    ***122.
    
    
    Validation summary report development.
    
    ***
    
    ***
 5




---



##### 



MANUFACTURING  SHIPPING
    
    WPCC
    
    MEDICIS123.
    
    
    Notification of special storage conditions for intermediate materials and/or
finished product.
    
    ***
    
    ***124.
    
    
    Release/rejection of finished goods for shipping to market
    
    ***
    
    ***125.
    
    
    Selection of carrier for shipping and shipping conditions.
    
    ***
    
    ***126.
    
    
    Preparation of shipping documents.
    
    ***
    
    ***127.
    
    
    Arrangement of shipping details including, but not limited to, pick up.
    
    ***
    
    ***128.
    
    
    Transmittal of production batch documents.
    
    ***
    
    ***
 6




---



##### 



Approval Signatures
 . ,
 WellSpring Pharmaceutical Canada Corp.Garnet ThompsonAssociate Director, Quality Assurance and ComplianceWellSpring Pharmaceutical Canada Corp.
    
    DateJames BookerDirector, Quality and Regulatory AffairsMedicis Global Services CorporationTom MillerExecutive Director of Quality OperationsMedicis Global Services CorporationTerri MageeDirector of Quality Control
 7




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##### 



Appendix I
 PRODUCT LIST
 Laboratory*Packaging
    
    (or noted inProduct Code
    
    Product Name
    
    Dosage
    
    Configuration
    
    Appendix III)***
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
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    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ***
  1of 1




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##### 



Appendix II
 CONTACT LIST
 WellSpring
    
    Medicis***
    
    ******
    
    ***
  1 of 2




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##### 



Appendix II
 CONTACT LIST
 WELLSPRING CANADAS PRIMARY QUALITY CONTACTS
 Contact Name
    
    Title
    
    Telephone Number
    
    e-mail***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
 MEDICIS PRIMARY QUALITY CONTACTS
 Contact Name
    
    Title
    
    Telephone Number
    
    e-mail***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
  2 of 2




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##### 



Appendix III
 APPROVED OUTSIDE LABORATORIES
 Additional Lab
    
    Tests by Nucro-
    
    Tests by Bodycote-Raw Material
    
    Analytical Lab
    
    Reqd?
    
    Technics,
    
    ORTECH Inc.***
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ***
 Additional Lab
    
    Tests by Nucro-
    
    Tests by Bodycote-Packaging Material
    
    Analytical Lab
    
    Reqd?
    
    Technics
    
    ORTECH, Inc.***
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ******
    
    ***
    
    ***
    
    ***
    
    ***
  Appendix IIIPage 1 of 1




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##### 



EXHIBIT C
 FORM OF CERTIFICATION REQUIRED PURSUANT TO SECTION 3.5
 Agreement WellSpring Pharmaceutical Canada Corp. Supplier Medicis
 [title]
  By:Title:
 Exhibit C
Medicis/Wellspring Master manufacturing AgreementPage 1 of 1