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DOCUMENT TITLE:  COMMERCIAL MANUFACTURING AGREEMENT Salix Pharmaceuticals, Inc., Mesalamine Controlled Release Capsules .
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Clause Heading
ARTICLE 1 - DEFINITIONS
2.1 - Validation Services.
2.2 - Supply and Purchase of Product.
2.3 - Product Maintenance Services.
2.4 - Other Related Services.
ARTICLE 3 - MATERIALS
3.2 - Raw Materials.
3.3 - Artwork and Packaging.
3.4 - Reimbursement for Materials.
4.2 - Forecast.
4.3 - Purchase Orders.
4.4 - Postponement of Processing Date.
4.5 - Modification of Purchase Orders.
4.6 - Delivery.
4.7 - Observation of Processing.
4.8 - Inability to Supply.
4.9 - Back-Up Trigger.
5.1 - Testing; Releasing; Rejection.
5.2 - Discrepant Results.
5.3 - Defective Processing.
5.4 - Supply of Material for Defective Product.
6.1 - Delivery.
6.2 - Failure to Take Delivery.
7.1 - Fees.
(C) - Other Fees.
7.2 - Unit Pricing Adjustments.
7.4 - Payment Terms.
7.5 - Taxes.
7.6 - Client and Third Party Expenses.
7.7 - Development Batches.
ARTICLE 8 - CHANGES TO SPECIFICATIONS
9.1 - Batch Records and Data.
9.2 - Recordkeeping.
9.3 - Regulatory Compliance.
9.4 - Governmental Inspections and Requests.
9.5 - Client Inspections and Audits.
9.6 - Recall.
9.7 - Quality Agreement.
10.1 - Mutual Obligation.
10.2 - Definition.
10.3 - Exclusions.
10.4 - No Implied License.
10.5 - Return of Confidential Information.
10.6 - Survival.
ARTICLE 11 - INTELLECTUAL PROPERTY
12.1 - Catalent.
12.2 - Client.
12.3 - Limitations.
13.1 - Indemnification by Catalent.
13.2 - Indemnification by Client.
13.3 - Indemnification Procedures.
14.1 - CATALENTS LIABILITY UNDER THIS AGREEMENT FOR ANY AND ALL CLAIMS FOR LOST, DAMAGED OR DESTROYED API OR OTHER CLIENT-SUPPLIED
15.1 - Catalent Insurance.
16.3 - Effect of Termination.
15.2 - Client Insurance.
16.1 - Term.
16.2 - Termination.
16.4 - Survival.
ARTICLE 17 - NOTICE
18.1 - Entire Agreement; Amendments.
18.2 - Captions; Certain Conventions.
18.3 - Further Assurances.
18.4 - No Waiver.
18.5 - Severability.
18.6 - Independent Contractors.
18.7 - Successors and Assigns.
18.8 - No Third Party Beneficiaries.
18.9 - Governing Law.
18.10 - Alternative Dispute Resolution.
18.11 - Prevailing Party.
18.12 - Publicity.
18.13 - Force Majeure.
18.14 - Counterparts.