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DOCUMENT TITLE:
DATA TRANSFER, CLINICAL TRIAL AND MARKET SUPPLY AGREEMENT
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Here are the clause headings in the document. To view the clause, click the clause heading.To view the full document, click the "View Document" button.
Clause Heading
2.1.1 - Documentation
2.1.2 - Material
2.1.3 - Data
2.1.4 - Support
2.1.5 - Contact with HEALTH AUTHORITIES
2.1.6 - Shipment of Material by InterMune
2.2.1 - Scope of Services.
2.2.2 - Comparison of Documentation and Materials
2.2.3 - Production Runs
2.2.4 - Additional Runs
2.2.5 - Additional Documentation
2.2.6 - Regulatory Support
2.2.7 - Format and Content of Documents
2.2.8 - Standard of Performance
3.1 - General
3.2 - Forecasts
3.3 - Purchase Orders
3.4 - Shipment of DRUG PRODUCT and Material by BI Austria
3.5 - Testing and Rejection
3.6 - Increase of Manufacturing Capacity
3.7 - Second Source Manufacturer
3.8 - MATERIAL SUPPLY BREACH
3.9 - Quality Agreement
4 - Prices and Payment
5.1 - RELEASE of Product
5.2 - Storage of Records and Batch Samples
5.3 - Final Release
5.4 - Third Party Services
5.5 - Consent to Changes
5.6 - Inspections by HEALTH AUTHORITIES
5.7 - Audits by InterMune
5.8 - Manufacturing Facilities
5.9 - Compliance with Law
5.10 - Environmental
6.1 - PROJECT TEAM
6.2 - Steering Committee
6.3 - Limitation of Powers
8 - Complaints; Adverse Events; Recalls
8.4 - Insurance
9 - Representations And Warranties
10 - Indemnification
11 - Limitations On Liability
12 - Confidentiality
13.1 - Duration
13.2 - Early Termination
13.3 - Effect of Termination
14.1 - Performance by AFFILIATES
14.2 - Force Majeure
14.3 - Assignment
14.4 - Notices
14.5 - Dispute Resolution; Governing Law
14.6 - Independent Contractor
14.7 - Waiver
14.8 - Severability
14.9 - Entire Agreement
14.10 - Headings
14.11 - Ambiguities
14.12 - Counterparts
14.13 - English Language