Exhibit 10.10
  SECOND AMENDED AND RESTATED MANUFACTURING AND SUPPLY AGREEMENT
 THIS SECOND AMENDED AND RESTATED MANUFACTURING AND SUPPLY AGREEMENT Agreement th Effective Date Santarus, Inc. Santarus Patheon Inc. Patheon Party Parties
 RECITALS
       ARTICLE 1
DEFINITIONS
 1.1 Affiliate




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1.2 Annual OME Cap *  *  *
 1.3 Applicable Laws
 1.4 Bulk OME
 1.5 Business Day
 1.6 Capital Agreement
 1.7 Certificates of Compliance
 1.8 cGMP
 
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Food and Drug Regulations
  1.9 Commencement of Commercial Manufacturing
 1.10 Deficiency Notice
 1.11 Effective Date
 1.12 Existing Line Capacity
 1.13 Facility
 1.14 FDA
 1.15 FFDCA
 1.16 Financial Penalty
 1.17 Finished Product
 1.18 Firm Purchase Order
 1.19 Forecast
 1.20 Foreign Regulatory Authority
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1.21 Government Authority
 1.22 INDA
 1.23 Invention
 1.24 Laws
 1.25 Line
 1.26 Long Forecast
 1.27 Minimum Run Quantity Exhibit A
 1.28 NDA
 1.29 OME
 1.30 OME Reimbursement Value *  *  *
 1.31 Other Invention
 1.32 Patheon Manufacturing Responsibilities
 1.33 Patheon Powder Supply Commitment
 1.34 Price
 1.35 Product Invention
 
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1.36 Product Patents
 1.37 Quality Agreement
 1.38 Raw Materials
 1.39 Regulatory Approval
 1.40 Responsible Executive
 1.41 Specifications
 1.42 Term
 1.43 Territory
 1.44 Third Party
 ARTICLE 2
SUPPLY, STORAGE, AND DELIVERY OF FINISHED PRODUCT
 2.1 Supply of Finished Product.
 *  *  *
 
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2.2 Commercial Supply.
 Supply Obligations * * *
 Forecasts
 * * * Forecast * * *
 * * * *  *  * Long Forecast * * * * * *
 Firm Purchase Orders Firm Purchase Order * * *
 Patheon Powder Supply Commitment * * *
 Firm Purchase Order Amendments * * * * * * * * *
 
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*  *  *
 2.3 Shipping and Delivery of Finished Product.
 2.4 Title and Risk of Loss.
 2.5 Documentation and Customs. Pre-shipping Documentation
 
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2.6 Invoices. *  *  *
 2.7 Late Delivery/Shortages and Overages.
 * * * * * * * * * * * * * * *
 * * * * * * * * *
  * * *
 * * *
 * * *
 * * *
 
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* * *
 * * *
 2.8 Key Performance Indicators.
 * * * * * * * * * KPIs * * * * * * * * * * * *
  * * * Remediation Plan * * * Stage 1 Failure
 [* * *] * * * Stage 2 Failure
 *  *  *
   
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(i)
    
    Santarus failure to have delivered to Patheon adequate
supplies of Bulk OME;(ii)
    
    Santarus failure to deliver Forecasts in accordance with
Section 2.2.2;(iii)
    
    Santarus failure to timely deliver amended Specifications in
the event that the Specifications are amended pursuant to Section 3.6.1 or
3.6.2;(iv)
    
    Santarus failure to deliver the Firm Purchase Orders in
accordance with Sections 2.2.3 and 2.2.5; or(v)
    
    Santarus failure to timely complete the final release of the
Finished Product in the absence of any production or quality issues.
 2.9 Storage of Finished Product.
 2.10 Multi-Country Packaging Requirements.
 2.11 OME Reconciliation and Yield.
 Inventory Reports * * * * * * *  *  * * * * * * * * * *
 Quantity Received:
 Quantity Dispensed:
 
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Quantity Converted:
 [ * * * ] Physical Inventory. * * * * * * * * * * * *
 Annual Average Yield * * * Annual Average Yield AAY Exhibit B Target Yield AAY AAY AAY * * * * * * * * *
 * * *
 AAY
 Other OME Losses
 * * *
 2.12 Cooperation and * * * Review. Relationship Team *  *  *
 ARTICLE 3
STANDARDS OF MANUFACTURE
 3.1 Finished Product.
 
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* * * * * * Patheon Manufacturing Responsibilities
 3.2 Manufacturing Facility.
 3.3 Testing and Release by Patheon. [* * *] * * * *  *  * (Patheon Release Testing)
 
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3.4 Stability Studies.
 3.5 Acceptance Procedures.
 Finished Product Claims Deficiency Notice * * * * * * * * * * * * * * *
 Determination of Deficiency *  *  * * * * * * * * * *
 
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*  *  *
 Patheon Responsibility * * *
 3.6 Specification Amendments.
 Cooperation
 Santarus Request for Change
 Patheons Request for Change
 Price Adjustments
 3.7 Records. provided, however
 
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3.8 Audit.
 ARTICLE 4
REGULATORY MATTERS AND QUALITY CONTROL
 4.1 Compliance by Patheon.
 4.2 Santarus Regulatory Responsibility.
 4.3 Manufacturing Process.
 4.4 Communications.
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4.5 Government Inspection.
  *  *  * * * *
 * * *
  
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4.6 Environmental and Other Laws and Regulations.
 4.7 End-User Inquiries and Complaints.
 4.8 Quality Agreement *  *  *
 ARTICLE 5
ADVERSE EVENTS; RECALL
 5.1 Adverse Experience Reporting. * * * Adverse Experience
 
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* * * * * * * * *
 5.2 Notification and Recall. Recalls *  *  *
 5.3 Recall Expense. * * *
 ARTICLE 6
COMPENSATION; PAYMENT
 6.1 Price of Finished Product.
 
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* * *
 6.2 Changes in Price of Finished Product.
 (a)
    
    Annual Review. On or about [***] of
each year Patheon and Santarus will meet (in person or by telephone or video
conference) to consider whether any adjustment to the Price in respect of the Finished
Product upward or downward is appropriate to account for increases or decreases in the
cost of manufacture and/or the cost of Raw Materials. In considering whether a change
in the Price is justified, the Parties may consider all published economic data,
including without limitation, price indices that are demonstrated to have a rational
connection to the cost of Raw Materials or Patheons cost of manufacturing the Finished
Product.(b)
    
    Extraordinary Changes in Raw Material Costs. If at any time market
conditions result in Patheons cost of Raw Materials being materially greater than
normal forecasted increases, then Patheon shall be entitled to request an adjustment to
the Price to compensate it for such increased Raw Material costs. If at any time
market conditions result in Patheons cost of Raw Materials being materially lesser
than anticipated, then Santarus shall be entitled to request an adjustment to the Price
to compensate it for such reduced Raw Material costs. For the purposes of this Section
6.2(b), changes materially greater than normal forecasted increases or materially
lesser than anticipated shall be considered to have occurred if: (i) the cost of a Raw
Material increases or decreases, as applicable, by [* * *] or more of
the cost for that Raw Material upon which the Price then in effect was based; or (ii)
the aggregate cost for all Raw Materials required to manufacture the Finished Product
increases or decreases, as applicable, by [* * *] or more of the
total Raw Material costs for the Finished Product upon which the Price then in effect
was based. To the extent that the Price has been previously adjusted
pursuant to this Section 6.2(b) to reflect an increase or decrease in the cost of
one or more Raw Materials, the adjustments provided for in (i) and (ii) above shall
operate based on the costs attributed to such Raw Material (or Raw Materials) at the
time the last such adjustments were made.
  
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*  *  *
 * * *
 6.3 Payment Terms.
 6.4 Form of Payment.
 6.5 Taxes.
 6.6 Disputed Invoices.
 
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ARTICLE 7
RAW MATERIALS
 7.1 Purchase of Raw Materials.
 7.2 Storage of Bulk OME and Raw Materials. * * *
 7.3 Responsibility for Cost of Raw Materials.
 *  *  *
 * * *
 * * * [* * *]
 
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7.4 Disposal of Raw Materials. *  *  *
 ARTICLE 8
CONFIDENTIALITY
 8.1 Confidentiality; Exceptions. Confidential Information Disclosing Party Receiving Party
 8.2 Exceptions.
 
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8.3 Authorized Disclosure.
 8.4 Return of Confidential Information. provided however
 8.5 Equitable Relief.
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ARTICLE 9
INTELLECTUAL PROPERTY MATTERS
 9.1 Ownership of Intellectual Property.
 Product Inventions Other
Inventions
    9.2 Assignment.
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9.3 Assistance.
 ARTICLE 10
REPRESENTATIONS, WARRANTIES AND COVENANTS
 10.1 Representations and Warranties of the Parties.
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10.2 Additional Representations, Warranties and Covenants of Patheon.
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10.3 Additional Representations, Warranties and Covenants of Santarus.
    10.4 Disclaimer.
 ARTICLE 11
TERM AND TERMINATION
 11.1 Term Initial Term
 11.2 Termination for Cause. Remediation Period
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11.3 Termination for Bankruptcy.
 11.4 Regulatory Proceedings.
 11.5 Government Action.
 11.6 Termination for Discontinuation.
 11.7 Effect of Termination. *  *  *
 
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11.8 Accrued Rights.
 ARTICLE 12
INDEMNIFICATION; INSURANCE; LIMITATION OF LIABILITY
 12.1 Indemnification by Santarus. Claims
 12.2 Further Indemnification by Santarus
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12.3 Indemnification by Patheon. *  *  *
 12.4 Indemnification Procedure. Indemnitee Indemnitor
 provided however
  
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provided however
  12.5 No Consequential Damages. UNDER NO CIRCUMSTANCES SHALL EITHER PARTY BE RESPONSIBLE OR
LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, PUNITIVE
OR OTHER LIKE DAMAGES, OR FOR ANY LOSS OF PROFITS, LOSS OF REVENUE, LOSS RESULTING FROM
INTERRUPTION OF BUSINESS OR LOSS OF USE OR DATA , EVEN IF SUCH PARTY, OR ANY OF ITS DIRECTORS,
OFFICERS, EMPLOYEES, OR AGENTS HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND
NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY OF ANY KIND, UNDER ANY
CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER THEORY, ARISING OUT OF OR RELATING IN ANY WAY TO
THIS AGREEMENT OR ITS IMPLEMENTATION. FOR THE AVOIDANCE OF DOUBT, NOTHING IN THIS SECTION 12.5
SHALL BE INTERPRETED TO LIMIT THE INDEMNIFICATION OBLIGATION OF EITHER PARTY IN CONNECTION WITH A
PRODUCT LIABILITY CLAIM WITH RESPECT TO THE CHARACTERIZATION OF DAMAGES OR LOSSES CLAIMED BY A
THIRD PARTY AS BEING INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, PUNITIVE OR OTHER
LIKE DAMAGES OR LOSSES.
 12.6 Insurance. *  *  * * * *
 
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12.7 Limitation of Liability.
 Active Materials
 Recall Expenses *  *  *
 ARTICLE 13
GOVERNING LAW; DISPUTE RESOLUTION
 13.1 Governing Law.
 13.2 Dispute Resolution/Injunctive Relief.
 Negotiation Between Responsible Executives
 Arbitration
 
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Exceptions
 Continuation of Performance
 ARTICLE 14
CAPITAL CONTRIBUTIONS
 14.1 Capital Reimbursement Agreement. Capital Agreement *  *  *
 14.2 Manufacturing Tools. Manufacturing Tools
 14.3 Personnel.
 
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ARTICLE 15
MISCELLANEOUS
 15.1 Assignment.
 15.2 Force Majeure.
 15.3 Further Actions.
 15.4 Compliance With Laws.
 15.5 Notices.
 If to Patheon:
    
    Patheon Inc.2100 Syntex CourtMississauga, OntarioCanada L5N 7K9Attn: President
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With a copy to:
    
    Patheon Inc.2100 Syntex CourtMississauga, OntarioCanada L5N 7K9Attn: General CounselIf to Santarus
    
    Santarus, Inc.3721 Valley Centre Drive, Suite 400San Diego CA 92130Phone: 858-314-5700Fax: 858-314-5701Attn: Sr. Vice President, Manufacturing and Product
DevelopmentWith a copy to:
    
    Santarus, Inc.3721 Valley Centre Drive, Suite 400San Diego CA 92130Phone: 858-314-5700Fax: 858-314-5702Attn: Legal Affairs
  15.6 Waiver. Right
 15.7 Disclaimer of Agency.
 15.8 Severability.
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15.9 Entire Agreement.
 15.10 Modification.
 15.11 Trademarks and Trade names.
 15.12 Construction.
 15.13 Counterparts.
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Patheon Inc.
    
    Santarus, Inc.By:
    
    /s/ Eric Evans
    
    By:
    
    /s/ Gerald T. ProehlName:
    
    Eric Evans
    
    Name:
    
    Gerald T. ProehlTitle:
    
    Chief Financial Officer
    
    Title:
    
    President & CEO
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EXHIBIT A
 MINIMUM RUN QUANTITY
 Minimum Run Quantity
  *  *  *
 * * *
 * * *
 * * *
 * * *
 * * *
 * * *
 * * *
 
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EXHIBIT B
 TARGET OME YIELDS
 Target OME Yields * * *
  *  *  *
 * * *
 
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