Exhibit 10.85
 
 1
 Supply Agreement
 Client Name:
    
    
    QUESTCORAgreement Effective Date:
    
    
    01/21/2010
 1111 South Palm Street
Baltimore, MD 21230
(Ph) 410-843-51100
(Fax) 410-843-4414
 
 1
    
    [***]: Certain confidential information contained in this document marked
with [***] has been omitted and filed separately with the Securities and Exchange Commission
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




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PROJECT PROPOSAL
 Contact Information:
 TO
    
    Dave Medeiros
    
    FROM
    
    Greg MinoSVP, Manufacturing
    
    
    
    Director, BD & PMQuestcor Pharmaceuticals, Inc.
    
    
    
    Cangene bioPharma, Inc.3260 Whipple Road
    
    
    
    1111 South Paca StreetUnion City, CA 94587
    
    
    
    Baltimore, MD 21230DMedeiros@questcor.com
    
    
    
    mingog@cblinc.comPh: (510) 400-0772
    
    
    
    Ph: 410- 843-5005 x 2088Fax: (510) 400-0715
    
    
    
    Fax: 410-843-4414
 Product info:
 Product Name
    
    HP Acthar GelPresentation
    
    Vial/liquid presentationRegulatory Status
    
    Commercial
 General Assumptions:
  1
    
    Provide processing and laboratory equipment for each manufacturing run.2
    
    Perform all work under approved Cangene bioPharma SOPs and/or protocols.3
    
    Ensure that all product contact equipment is either virgin, product
dedicated, or released as clean by validated cGMP methods.4
    
    Perform validation work as listed within this proposal, which will, in
general, precede the sterile fill.5
    
    Fill product gravimetrically with density data obtained during development.6
    
    Write a Cangene bioPharma batch record, which is developed from
information provided by the Client.7
    
    Provide Client with a copy of the completed Batch Production Record,
including a Certificate of Analysis.
  1
    
    Provide to Cangene bioPharma the Signed Proposal Acceptance Sheet
prior to project commencement (commencement activities include
development of timeline, ordering of any project-related materials or
development of protocols/batch records).2
    
    Provide all pertinent product information such that Cangene bioPharma
can assure employee safety. For small molecules and polymers, Cangene
bioPharma requires the chemical structure of the API. For peptides,
proteins or nucleic acids, Cangene bioPharma is looking for suitable
chemical characterization data. For biologicals, safety documentation
must include testing for viral markers and validation of viral
clearance steps in the manufacture of API.3
    
    Provide those items as agreed upon and which may include container and
closures, pre-released bulk product, MSDS, Certificate of Analysis,
label text, assay methods, reference standard and other documentation.4
    
    Approve the batch record by signature.5
    
    Secure any necessary approvals for the use of the product.6
    
    Perform all additional testing necessary for release of the product
not performed by Cangene bioPharma.
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Agreement purpose :
  RECITALS
 A.
    
    Questcor is in the business of developing and commercializing drug products.B.
    
    Cangene bioPharma is in the business of formulating, sterilizing, filling, and
packaging liquid injectable drug products.C.
    
    Questcor and Cangene bioPharma desire to enter into this Agreement in order to
establish the terms and conditions under which Cangene bioPharma will formulate, fill,
and package for Questcor the various Products included in the Product Descriptions at
Exhibit A hereto.
  ARTICLE I
  ARTICLE II
   ARTICLE III
  3




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ARTICLE IV
 †
 
 [***]
    
    CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION 4




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Project Activities :
 Equipment & Materials
 Project Specific Direct Expenses
  Laboratory Support Activities
 Manufacturing Support Activities
 Engineering Run
    Documentation Support Activities
 Master Batch Record Revision
  5




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Other Documentation
  ‡
 Manufacturing Activities
 Fill Price
  a)
    
    Purchase and GMP receipt of excipients, components, other materialsb)
    
    Sufficient trained operators using [***] clean room and necessary ancillary
equipment and facilities [***] for the express purpose of manufacturing client
product according to a batch record that has been pre-determined and agreed to
by Cangene bioPharma and the client.c)
    
    A [***] room and trained [***] personnel [***] as may be required by the
agreed batch record and inclusive of the filling time overlap.d)
    
    Standby, on call laboratory personnel to perform in process QC testing.e)
    
    Environmental monitoring before, during and after the fill and trained
environmental personnel.f)
    
    Post process cleaning and metrology overhead such as equipment maintenance,
calibration, and sterile filter integrity testing.g)
    
    Visual inspection of [***].h)
    
    Finished product analytical testing that is performed at Cangene bioPharma.i)
    
    Sterility Testingj)
    
    Quality assurance review of all GMP paperwork.k)
    
    One copy of the completed batch record on file at Cangene bioPharma,
including all associated CofAs, environmental reporting, and analytical and
microbiological results.
 QA/Regulatory Requirements & Support
 Investigations
  
 [***]
    
    CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION 6




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Regulatory Affairs Support
  
    
    Meetings with government (US or foreign) authorities, whether in person or by phone.
    
    Preparation of documents in anticipation of a pre-Approval Inspection (PAI).
    
    Audits of Cangene bioPharma by or on the behalf of the client in excess of one per
year.
    
    All audit correspondence beyond the initial response, including client requested
revisions to Cangene bioPharmas audit response.
    
    Letters of reference from Cangene bioPharma or Cangene bioPharmas vendors that are
requested by the client. (e.g. Master file reference letters, rubber or glass component vendor
letters)
    
    Documentation provided to regulatory authorities on behalf of the client. (e.g. GMP
compliance and Debarment letters)
    
    All correspondence and documentation generated for or on the behalf of the client.
    
    Annual product reviews for commercial products, as required by the controlling
regulatory authority.
    
    All time used for collecting and photocopying client documentation. One copy of a
complete batch record is exempted from support charges.
 7




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Pricing Page :
 Equipment & Materials
 Qty
    
    Activity
    
    Deliverable
    
    Price
    
    Estimated Total(***§)
    
    Project Specific
Direct Expenses
(invoiced with each
fill)
    
    Invoice
    
    [***]
    
    [***]
 Laboratory Support Activities
 Cangene bioPharma will notify N/A should testing yield aberrant or
out-of-specification data. All work (including time spent reviewing the
investigation with Laboratory management and quality assurance personnel)
associated with Laboratory investigations that are not deemed laboratory error
will be charged to N/A at the hourly rate. N/A also agrees to pay for any
retests that confirm the original test results including marginal pass/fail
results. Cangene bioPharma will revise transfer protocols and/or final reports
once at no additional charge upon N/A request. Additional revisions to
protocols or final reports will be conducted at the hourly rate. N/A will not
be charged for revisions required due to Cangene bioPharma error.
 Manufacturing Support Activities
 Qty
    
    Activity
    
    Deliverable
    
    Price
    
    Estimated Total[***]
    
    Engineering Run *
- If required
    
    Report
    
    [***]
    
    [***]
 
 *
    
    Unanticipated results may result in the need for additional Engineering runs or other studies. Documentation Support Activities
 Qty
    
    Activity
    
    Deliverable
    
    Price
    
    Estimated Total[***]
    
    Master Batch Record Revision
    
    Master Batch Record
    
    [***]
    
    [***][***]
    
    Other Documentation
    
    TBD
    
    [***]
    
    [***]
 Manufacturing Activities
 Qty
    
    Activity
    
    Deliverable
    
    Price
    
    Estimated Total[***]
    
    Fill Price  [***]
[***]
    
    Batch Record
    
    [***]
    
    [***]
 QA/Regulatory Requirements & Support
 Qty
    
    Activity
    
    Deliverable
    
    Price
    
    Estimated Total[***]
    
    Investigations
    
    Report
    
    [***]
    
    [***][***]
    
    Regulatory Affairs Support
    
    Support
    
    [***]
    
    [***]
 
 [***]
    
    CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY
WITH THE COMMISSION 8




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Terms : Purchase Orders for any work under this agreement are to be issued.
 
    
    (*****). at shipment of executed batch record, [***]
    
    Qualification/Validation Studies will be invoiced when each report is sent to
the client completed or for signature (if required), [***]
    
    [***]
    
    Cangene bioPharmas Cancellation and Terms and Conditions policies apply.
    
    Hazardous or medical waste will be manifested and discarded as required by state
and federal laws. [***]
 Cangene bioPharma Scheduling Policy
  
    
    Clients will provide to Cangene bioPharma a [***] forecast [***].
    
    Clients will provide [***] materials identified as being client supplied materials to
Cangene bioPharma with proper documentation [***] in advance of a fill.
    
    Clients shall supply a Purchase Order for batches to be filled [***].
    
    Cangene bioPharma requires that an approved master batch record for the fill along with
any other project specific materials be in place prior to a firm fill date being assigned.
  
 [***]
    
    CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY
WITH THE COMMISSION 9




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[***]
 Cangene bioPharma Cancellation Policy
 1.
    
    Clean room [***] will not be assigned without a valid purchase order.2.
    
    All purchase orders must be accompanied by the requisite prepayment.3.
    
    If a fill is CANCELLED, the fee schedule in effect at the time of the cancellation will
apply. [***]4.
    
    If the project or a project vignette is terminated by the client, all hours obligated against
the project will be billed [***]. Additionally, an early project termination fee [***]
applies to project cancellation.5.
    
    Once a fill is cancelled, a new quote and purchase order will be required to renew the order.
 Cangene bioPharma Document Approval Policy
   
    
    Master Batch Records: [***]
    
    (Routine Validation or Laboratory Reports: [***]
    
    Technical Transfer and Process Validation Reports: [***]
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
    
    Deviations: [***] (Failure to return deviations promptly will affect executed batch
release times)
    
    Investigations: [***]
  Cangene bioPharma Project Completion Policy
    Cangene bioPharma Inventory Return Policy
  ††
  
 [***]
    
    CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY
WITH THE COMMISSION 11




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PROPOSAL ACCEPTANCE SHEET
   Accounts Payable
    
    
    
    Optional additional Addressee:Name:
    
    
    
    
    
    Name:Telephone No.:
    
    
    
    
    
    Address:Address:
  Questcor Pharmaceuticals, Inc.
    
    
    
    Cangene bioPharma, Inc.Signature
    
    
    
    SignatureGeneral ManagerTitle
    
    
    
    TitleVicki Wolff-LongName (type or print)
    
    
    
    NameDate
    
    
    
    Date
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Cangene bioPharma, INC.  Terms and Conditions Precedent w the Acceptance of a Purchase Order
 1.
    
    Cangene bioPharma will be responsible for dutifully performing instructions according to a
batch record, which has been jointly agreed to by the Customer and Cangene bioPharma. The
customer acknowledges that the work to be performed by Cangene bioPharma is experimental in
nature and portions of the work may not have been fully validated within generally accepted
standards of the pharmaceutical industry. As such, Cangene bioPharma will not be responsible
for unexpected results that can be attributed to a process or procedure either supplied by, or
requested by the Customer, that has not been fully validated.2.
    
    All documentation and submissions to regulatory authorities in support of the Customers
product are the responsibility of the Customer. No documentation will be provided by Cangene
bioPharma except as specifically contracted between the Customer and Cangene bioPharma.3.
    
    Cangene bioPharma makes no representation or warranties regarding the suitability of the
Customers product for any purpose whatsoever, or for the efficacy of such product.4.
    
    The Customer is solely responsible for providing complete and accurate scientific data to
Cangene bioPharma regarding Customers product and Customers requirements for formulation,
fill and finish of Customers product.5.
    
    In accepting its obligations under the terms of the Purchase Order, Cangene bioPharma has
relied upon the accuracy, completeness and correctness of the data and information provided by
the Customer in developing the project, any associated time line and the estimated or fixed
cost for the project. It is understood by the Customer that additional charges may be billed
to the Customer in the event that any data or information provided by the customer proves to
be incorrect, incomplete or in error and as a result requires more effort by Cangene bioPharma
than anticipated in the original project proposal.6.
    
    The Customer warrants to Cangene bioPharma that all substances delivered by Customer to
Cangene bioPharma will be free of hazardous or toxic material and that no specific safe
handling instructions are applicable to any such substance or materials, except as disclosed
to Cangene bioPharma in writing by Customer in sufficient time for review by Cangene bioPharma
and prior to delivery to Cangene bioPharma.7.
    
    The Customer represents and warrants to Cangene bioPharma that all finished product delivered
by Cangene bioPharma to Customer will be held and/or used or disposed of by Customer in a safe
and responsible manner, and in accordance with all applicable laws, rules and regulations.8.
    
    Prepayment fees (not including Commencement/Project initiation fees), where applicable, are
refundable less charges under Cangene bioPharmas Cancellation and Postponement Policyand/or
the expenses incurred by Cangene bioPharma prior to the cancellation or postponement. Other
payments including Commencement/Project Initiation fees are non-refundable.9.
    
    The specific work to be invoiced by Cangene bioPharma is set forth in the quote. The
Customer acknowledges that the quote may be inadequate due to unforeseen circumstances which
increase the amount of work required to complete the project. Cangene bioPharma will notify
the customer immediately if the costs to complete the project exceed the proposed budget. No
additional work involving charges in excess of the project quote will commence without
customer approval.10.
    
    The Customer acknowledges and agrees that Cangene bioPharmas liability to Customer is
limited to the value of the amounts invoiced by Cangene bioPharma and that Cangene bioPharmas
obligations to Customer are limited to performance by Cangene bioPharma of services
(formulation, sterilization, fill and finish) in accordance with the master batch record and
applicable Good Manufacturing Practices (GMPs). Accordingly, except to the extent of value
of the work invoiced, notwithstanding. Cangene bioPharmas negligence or failure to perform
in accordance with applicable GMPs and the batch record, Cangene bioPharma shall have no
responsibility or obligation to Customer for Customers pharmaceutical product delivered to
Cangene bioPharma, or for any delay encountered by Customer in its product development or
product approval process, resulting from Cangene bioPharmas actions or inactions.11.
    
    In the course of performing its obligation under the terms of the Purchase Order, Cangene
bioPharma may purchase materials in anticipation of events identified by the Quotation to
which the Purchase Order has authorized work or by Customer signed change orders to the same.
Should those materials become unusable to the project as a consequence of delays in or changes
to the project, including but not limited to postponement or cancellation, and whether such
delays or changes can be attributed to the actions or inactions of Cangene bioPharma, the cost
of such materials will be invoiced to the customer and the customer agrees to pay to Cangene
bioPharma the amounts so invoiced.12.
    
    The arrangement between Cangene bioPharma and Customer is one of service provider and
Customer. No joint venture, partnership or agency is to be created or deemed as between
Cangene bioPharma and Customer.13.
    
    The Customer agrees to indemnify and hold Cangene bioPharma and its employees and agents
harmless from any claim or liability, including attorneys fees, incurred or made against
Cangene bioPharma arising out of or relating to any breach of any representation or warranty
made by Customer to Cangene bioPharma hereunder, or otherwise, including, without limitation,
any claim or liability asserted by any participant in any clinical trial of Customers
product.14.
    
    Cangene bioPharma shall not be liable for the replacement or for the cost or value of any
Active Ingredient, Materials or production equipment supplied to Cangene bioPharma by the
Customer including but not limited to any Active Ingredient Materials or production equipment
lost or damaged or incorporated into any rejected or nonconforming batch of product.
 13