##### 



EXHIBIT
10.2
 CONFIDENTIAL TREATMENT REQUESTED
 QUALITY AGREEMENT
 THIS AGREEMENT th
  AVANIR PHARMACEUTICALS,
 Avanir
  PATHEON INC.
  ***
 ***
 ***
 Patheon
 MSA
  
 ***
    
    Certain confidential portions of
this Exhibit were omitted by means of blackout of the text (the
Mark). This Exhibit has been filed separately with the Secretary
of the Commission without the Mark pursuant to the Companys
Application Requesting Confidential Treatment under Rule 24b-2
under the 1934 Act.




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##### 



- 2 -    ARTICLE 1
 RESPONSIBILITIES
 1.1
  Avanir
    
    Patheon1.
    
    Provide Specifications.
    
    X2.
    
    Manufacture and package Product in strict adherence
to the Specifications.
    
    
    
    X3.
    
    Permit audits of all relevant premises, procedures
and documentation by Avanir, and permit inspection by
regulatory authorities.
    
    
    
    X4.
    
    Patheon may arrange for subcontractors to perform specific
testing services for Products and Components; provided
that (1) all such subcontractors will be duly qualified by
Patheon under GMP and Applicable Laws to perform such
testing; (2) Patheon will at all times remain fully
responsible to Avanir for the performance of all
obligations pursuant to the MSA related to such
subcontracted testing services; and (3) no subcontractors
will be utilized to perform release testing of the
Product.
    
    
    
    X5.
    
    Provide copies of all information and correspondence
regarding Annual Product Reviews when requested by Avanir.
    
    
    
    X6.
    
    Notify and obtain approval from Avanir prior to
implementation of any proposed changes to the process,
materials, testing, equipment or premises that may affect
the Product, such Avanir approval not to be unreasonably
withheld.
    
    
    
    X




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##### 



- 3 - Avanir
    
    Patheon7.
    
    Notify Avanir within *** of
receipt of any Form 483s, warning letters or the like
from applicable regulatory agencies relating to: (i) the
Product; or (ii) if the supply of Products will be
affected, the facilities used to produce, test or package
the Product. Responses related to the Product shall be
reviewed and approved by Avanir prior to submission to the
applicable regulatory agency, provided that Patheon
reserves the right to respond to such regulatory agencies
without approval, if, in the reasonable opinion of
Patheons counsel, it is required to do so.
    
    
    
    X8.
    
    Notify Avanir within ***of any
regulatory authority requests for Product samples, Batch
documentation, or other information related to the
Product.
    
    
    
    X9.
    
    Conduct operations in compliance with applicable
environmental, occupational health and safety laws and
cGMP regulations.
    
    
    
    X10.
    
    Investigate and resolve all medical and nonmedical
Product complaints.
    
    X
    
    (X)11.
    
    Investigate all manufacturing type Product complaints.
    
    
    
    X12.
    
    Initiate and control a Product recall.
    
    X
    
    (X)13.
    
    Liaise with Regulatory Authorities for approval,
maintenance and updating of marketing approval in a timely
manner.
    
    X
    
    (X)
  Avanir
    
    Patheon1.
    
    Establish applicable master validation plans and
maintain a validation program for the Product.
    
    X
    
    X2.
    
    Qualify (IQ/OQ) facilities, utilities and process
equipment.
    
    
    
    X3.
    
    Calibrate instrumentation and qualify computer
systems used in the manufacture and testing of the
Product.
    
    
    
    X
 
 ***
    
    Certain confidential portions of
this Exhibit were omitted by means of blackout of the text (the
Mark). This Exhibit has been filed separately with the Secretary
of the Commission without the Mark pursuant to the Companys
Application Requesting Confidential Treatment under Rule 24b-2
under the 1934 Act.




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##### 



- 4 - 4.
    
    Prepare and approve all performance qualification and
process validation protocols and reports, for
manufacturing, packaging, and analytical testing
operations.
    
    (X)
    
    X5.
    
    Review and approve master validation plan,
performance qualification and process validation
protocols and reports for the Product.
    
    X
    
    X6.
    
    Maintain an appropriate cleaning and cleaning
validation program.
    
    
    
    X7.
    
    Provide toxicological information to be used in the
development of a cleaning program.
    
    X8.
    
    Validate analytical test methods for finished Product.
    
    (X)
    
    X
  Avanir
    
    Patheon1.
    
    Provide the master formula.
    
    X2.
    
    Provide approved supplier list. Avanir to audit and approve
Component and Active Material suppliers and ensure cGMP compliance
where Avanir stipulates the supplier. Avanir stipulated supplier shall
be included on Avanirs approved supplier list (attached hereto as
Schedule D). Patheon to audit and approve Component and Active
Material suppliers and ensure cGMP compliance as per Patheon SOP where
Patheon stipulates the supplier. Patheon stipulated supplier shall be
included on Patheons approved supplier list (Schedule C). Avanir to
audit and approve, in its sole discretion, all Patheon stipulated
suppliers.
    
    X
    
    X3.
    
    Qualify and approve Active Materials supplier(s).
    
    X
    
    (X)4.
    
    Provide Active Materials specifications (including Certificates of
Analysis).
    
    X5.
    
    Procure Active Materials (including Certificates of Analysis).
    
    X6.
    
    Provide test methods for Active Materials (if non-Compendial).
    
    X7.
    
    Validate non-Compendial testing methods for Active Materials.
    
    (X)
    
    X8.
    
    Analyze and release Active Materials (including documentation and
Certificates of Analysis).
    
    (X)
    
    X




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##### 



- 5 - Avanir
    
    Patheon9.
    
    Retain reference sample of Active Materials for ***
past the expiration date of the last Batch of Product manufactured
with that material in the Product or such longer period required by
law.
    
    
    
    X10.
    
    Procure inactive ingredients (including Certificates of Analysis).
    
    
    
    X11.
    
    Provide test methods and method validation for inactive
ingredients (if non-Compendial).
    
    X12.
    
    Analyze and release inactive ingredients (including documentation
and Certificates of Analysis).
    
    
    
    X13.
    
    Retain reference samples of inactive ingredients for
*** past the expiration date of the last Batch
manufactured with that material in the Product or such longer period as
required by law.
    
    
    
    X14.
    
    Provide to Avanir, at Avanirs request, by means of a BSE/TSE
certificate of compliance from the raw material vendor, confirmation of
any bovine, caprine, or ovine derived raw materials purchased by
Patheon for the manufacture of Products.
    
    
    
    X
  Avanir
    
    Patheon1.
    
    Create, control, issue and execute master batch record.
    
    
    
    X2.
    
    Approve master batch record.
    
    X
    
    X3.
    
    Document, investigate and resolve deviations from
approved manufacturing instructions or Specifications.
Report and obtain approval from Avanir QA regarding Quality
Deviation Report (QDR) type deviations (incidents where
there is a potential to affect Product quality). Provide
copies of all QDRs to Avanir as part of master batch
record.
    
    
    
    X
  Avanir
    
    Patheon1.
    
    Create, control, issue and execute master batch record.
    
    
    
    X
 
 ***
    
    Certain confidential portions of
this Exhibit were omitted by means of blackout of the text (the
Mark). This Exhibit has been filed separately with the Secretary
of the Commission without the Mark pursuant to the Companys
Application Requesting Confidential Treatment under Rule 24b-2
under the 1934 Act.




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##### 



- 6 - Avanir
    
    Patheon2.
    
    Approve master packaging batch record.
    
    X
    
    X3.
    
    Provide specifications for packaging components.
    
    
    
    X4.
    
    Qualify and approve packaging component suppliers.
Patheon to audit and approve packaging component suppliers and
ensure cGMP compliance as per Patheon SOP where Patheon stipulates
the supplier. Patheon stipulated supplier shall be included on its
approved supplier list (Schedule C). Avanir to audit and approve, in
its sole discretion, all Patheon stipulated suppliers.
    
    (X)
    
    X5.
    
    Provide test methods and method validation for packaging
components. Where applicable, Patheon will provide such test
methods and validation for packaging components purchased from
suppliers on the Patheon approved supplier list only (Schedule C).
    
    (X)
    
    X6.
    
    Procure packaging components.
    
    
    
    X7.
    
    Analyze and release packaging components.
    
    
    
    X8.
    
    Retain reference samples of bulk Product for ***
past Product expiry or such longer period as required by law.
Avanir to retain legal sample of finished Product.
    
    (X)
    
    X9.
    
    Document, investigate and resolve any deviation from approved
packaging instructions or specifications. Report and obtain
approval from Avanir QA regarding QDR type deviations. Provide
copies of all QDRs to Avanir as part of master batch packaging
record.
    
    (X)
    
    X
  Avanir
    
    Patheon1.
    
    Provide finished Product specifications.
    
    X2.
    
    Supply / develop analytical test
methods for finished Product.
    
    X
    
    X3.
    
    Test finished Product.
    
    
    
    X4.
    
    Maintain all Batch records for a
minimum of ***past
Product expiry date and supply all such
records to Avanir upon request.
    
    
    
    X5.
    
    Maintain records and evidence on the
testing of raw materials and
packaging/labelling materials for
***after the materials
were last used in the manufacture or
    
    
    
    X
 
 ***
    
    Certain confidential portions of
this Exhibit were omitted by means of blackout of the text (the
Mark). This Exhibit has been filed separately with the Secretary
of the Commission without the Mark pursuant to the Companys
Application Requesting Confidential Treatment under Rule 24b-2
under the 1934 Act.




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##### 



- 7 - Avanir
    
    Patheonpackaging/labelling of the Product.6.
    
    Notify Avanir QA of confirmed
out-of-Specification results (OOS) within
***; Patheon to
generate QDR and obtain approval of the QDR
from Avanir QA.
    
    (X)
    
    X
  Avanir
    
    Patheon1.
    
    Store stability samples.
    
    
    
    X2.
    
    Develop and validate stability indicating assay.
    
    (X)
    
    X3.
    
    Provide stability testing protocol for finished Product.
    
    X4.
    
    Perform stability testing.
    
    
    
    X5.
    
    Notify the Avanir of any stability failure for Product
supplied to the Avanir.
    
    
    
    X
 ARTICLE 2
 COMPLIANCE BETWEEN PRODUCT REGISTRATION AND THE MANUFACTURING PROCESS
  (a)
    
    All proposed process changes shall be communicated to the Avanir for initial
review and approval, such Avanir approval not to be unreasonably withheld. The Avanir
shall be responsible for determining whether or not to initiate registration variation
procedures and for maintaining adequate control over the quality commitments of the
marketing authorization made to the regulatory authorities by the Avanir for Products.(b)
    
    Following validation of a process change, Patheon shall deliver a copy of the
related validation report to the Avanir and the associated stability data, if
applicable, as it becomes available.
 
 ***
    
    Certain confidential portions of
this Exhibit were omitted by means of blackout of the text (the
Mark). This Exhibit has been filed separately with the Secretary
of the Commission without the Mark pursuant to the Companys
Application Requesting Confidential Treatment under Rule 24b-2
under the 1934 Act.




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##### 



- 8 - 2.2
    
    Labelling / Packaging Material ChangesThe Avanir may initiate changes and shall review and approve any Patheon-proposed changes to
labelling or packaging, including a change in the supplier of any labelling or packaging
materials before any such change may be implemented.2.3
    
    Other ChangesPatheon will not make any changes in storage, shipping, facilities or equipment that affect
the Product, or process or procedure used to manufacture the Product, without first
obtaining written approval from Avanir (such approval not to be unreasonably withheld.2.4
    
    PermitsThe Avanir shall be solely responsible for obtaining or maintaining, on a timely basis, any
permits or other regulatory approvals in respect of the Products or the Specifications,
including, without limitation, all marketing and post-marketing approvals.
 ARTICLE 3
 BATCH RELEASE
   ***
 
 ***
    
    Certain confidential portions of
this Exhibit were omitted by means of blackout of the text (the
Mark). This Exhibit has been filed separately with the Secretary
of the Commission without the Mark pursuant to the Companys
Application Requesting Confidential Treatment under Rule 24b-2
under the 1934 Act.




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##### 



- 9 - ARTICLE 4
 BATCH DOCUMENTATION
 ***
 ***
 ARTICLE 5
 STABILITY
  ***
   ARTICLE 6
 VALIDATION
   
 ***
    
    Certain confidential portions of
this Exhibit were omitted by means of blackout of the text (the
Mark). This Exhibit has been filed separately with the Secretary
of the Commission without the Mark pursuant to the Companys
Application Requesting Confidential Treatment under Rule 24b-2
under the 1934 Act.




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##### 



- 10 -  ARTICLE 7
 GENERAL
    ARTICLE 8
 ADDITIONAL PROVISIONS
 8.1 Reporting ***
 8.2 Adverse Experience Reporting ***
 Adverse Experience
 
 ***
    
    Certain confidential portions of
this Exhibit were omitted by means of blackout of the text (the
Mark). This Exhibit has been filed separately with the Secretary
of the Commission without the Mark pursuant to the Companys
Application Requesting Confidential Treatment under Rule 24b-2
under the 1934 Act.




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##### 



- 11 -    ***
    Batch Documents Batch Documents
 
 ***
    
    Certain confidential
portions of this Exhibit were omitted by means of blackout of the
text (the Mark). This Exhibit has been filed separately with the
Secretary of the Commission without the Mark pursuant to the
Companys Application Requesting Confidential Treatment under Rule
24b-2 under the 1934 Act.




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##### 



- 12 - AVANIR PHARMACEUTICALS
    
    PATHEON INC.Name:
    
    
    
    Name:Signature:
    
    
    
    Signature:Date:
    
    
    
    Date:
 SCHEDULE A
 PRODUCT(S)
 Product(s)
    
    
    
    
    
    
    Galenic Form
    
    
    
    
    Dosage (strength)[***]
Bulk
    
    
    
    
    
    
    *
    **
    
    
    
    
    
    Dextromethorphan HBr/Quinidine
Sulfate ***[***]
Capsules
 
 ***
    
    Certain confidential
portions of this Exhibit were omitted by means of blackout of the
text (the Mark). This Exhibit has been filed separately with the
Secretary of the Commission without the Mark pursuant to the
Companys Application Requesting Confidential Treatment under Rule
24b-2 under the 1934 Act.




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##### 



SCHEDULE B
 QUALITY CONTACTS
 ***
 ***
 
 ***
    
    Certain confidential
portions of this Exhibit were omitted by means of blackout of the
text (the Mark). This Exhibit has been filed separately with the
Secretary of the Commission without the Mark pursuant to the
Companys Application Requesting Confidential Treatment under Rule
24b-2 under the 1934 Act.




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##### 



- 14 - SCHEDULE C
 PATHEON APPROVED SUPPLIER LIST
 ***
    
    
    *
    **
    
    
    *
    *****
    
    
    *
    **
    
    
    *
    *****
    
    
    *
    **
    
    
    *
    *****
    
    
    *
    **
    
    
    *
    **
 
 ***
    
    Certain confidential
portions of this Exhibit were omitted by means of blackout of the
text (the Mark). This Exhibit has been filed separately with the
Secretary of the Commission without the Mark pursuant to the
Companys Application Requesting Confidential Treatment under Rule
24b-2 under the 1934 Act.




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##### 



- 15 - SCHEDULE D
 AVANIR APPROVED SUPPLIER LIST
 ***
    
    
    *
    **
    
    
    *
    *****
    
    
    *
    **
    
    
    *
    *****
    
    
    *
    **
    
    
    *
    *****
    
    
    *
    **
    
    
    *
    *****
    
    
    *
    **
    
    
    *
    *****
    
    
    *
    **
    
    
    *
    *****
    
    
    *
    **
    
    
    *
    *****
    
    
    *
    **
    
    
    *
    *****
    
    
    *
    **
    
    
    *
    **
 
 ***
    
    Certain confidential
portions of this Exhibit were omitted by means of blackout of the
text (the Mark). This Exhibit has been filed separately with the
Secretary of the Commission without the Mark pursuant to the
Companys Application Requesting Confidential Treatment under Rule
24b-2 under the 1934 Act.