TABLE OF CONTENTS 1. QUALITY AGREEMENT 1 1.1 Purpose 1 1.2 Relationship to License Agreement 1 2. DEFINITIONS 1 3. ADMINISTRATIVE INFORMATION 1 3.1 ORPHAN Contact Names 1 3.2 CELLTECH Contact Names 1 3.3 Emergency Contacts Names 1 4. TERM OF AGREEMENT 2 5. MANUFACTURING GMP COMPLIANCE 2 5.1 General 2 5.2 Premises 2 5.3 GMP Guidelines 3 5.4 Materials 3 5.5 Master Production Records 4 5.6 Standard Operation Procedures and documentation 4 5.7 Methods Validation/Certification 4 5.8 Batch Numbers 4 5.9 Dates of Manufacture and Expiration 4 5.10 Manufacturing and Equipment Data 5 5.11 Storage and Shipment 5 6. QUALITY CONTROL 6 6.1 General 6 6.2 In-Process and Product Testing 6 6.3 Retain Samples 6 6.4 Routine Stability Program 7 6.5 Out-of-Specification (OOS) Investigations 7 6.6 Contract Quality Control Laboratories 7 7.1 Deviations and Investigations 8 7.2 Lot Disposition 8 7.3 Quality Assurance Certificate of Compliance/Analysis 8 7.4 Product Release 9 7.5 Product Complaints and Recalls 9 7.6 Records Retention 9 7.7 Quality Assurance Presence in the Manufacturing Facility 10 8. REGULATORY COMPLIANCE 10 8.1 Regulatory Compliance 10 8.2 Regulatory Actions 11 8.3 Regulatory Affairs 11 9. DISPUTE RESOLUTION 11 9.1 Non-Conformity Dispute 11 9.2 Other Disputes 12 10. CHANGE MANAGEMENT 12 10.1 Technical & cGMP Impact Assessment 12 11. PRODUCT AND PROCESS VALIDATION 13 11.1 Process Validation 13 11.2 Equipment, Computer, Facility and Utilities Qualification 13 11.3 Laboratory Qualification 13 12. ANNUAL PRODUCT REVIEW AND ANNUAL REPORT 14 12.1 Annual Product Review 14 Appendix 1 : ORPHAN and CELLTECH's responsibilities Appendix 2 : Formula and European Product Specifications Appendix 3 : Contact Names Appendix 4 : Release Documentation Appendix 5 : Specifications • Bulk Packaged Drug Product • Analytical Specifications Once Approved by EMEA * APPENDIX F CELLTECH FIRST COMMERCIAL YEAR FORECAST * APPENDIX G COMPONENTS OF STANDARD MANUFACTURING COST AND TRANSFER PRICE * APPENDIX H REGULATORY ASSISTANCE
