TABLE OF CONTENTS 1 Sample Clauses

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
Sample 1
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Related to TABLE OF CONTENTS 1

  • TABLE OF CONTENT 0 Abstract 6 1 Introduction 7

  • Table of Contents Page ARTICLE I GENERAL 3 Section 1.1 Defined Terms 3 ARTICLE II VOTING 5 Section 2.1 Agreement to Vote 5 Section 2.2 Grant of Proxy 6 ARTICLE III REPRESENTATIONS AND WARRANTIES 7 Section 3.1 Representations and Warranties of the Company T Shareholder 7 Section 3.2 Representations and Warranties of Company Y 8 ARTICLE IV OTHER COVENANTS 9 Section 4.1 Prohibition on Transfers of Company T Shares 9 Section 4.2 Prohibition on Transfers of Company Y Shares 9 Section 4.3 Additional Shares 10 Section 4.4 Share Dividends, etc. 10 Section 4.5 No Solicitation 10 Section 4.6 No Inconsistent Agreements 10 Section 4.7 Waiver of Appraisal and Dissenters’ Rights 11 Section 4.8 Documentation and Information 11 Section 4.9 Registration of ADS 11 Section 4.10 Further Assurances 11 ARTICLE V MISCELLANEOUS 12 Section 5.1 Interpretation 12 Section 5.2 Termination 13 Section 5.3 Governing Law and Venue 13 Section 5.4 Notices 14 Section 5.5 Amendment 14 Section 5.6 Extension; Waiver 15 Section 5.7 Entire Agreement 15 Section 5.8 No Third-Party Beneficiaries 15 Section 5.9 Severability 15 Section 5.10 Rules of Construction 15 Section 5.11 Assignment 16 Section 5.12 Specific Performance 16 Section 5.13 Company T Shareholder Capacity 16 Section 5.14 No Ownership Interest 16 Section 5.15 Costs and Expenses 16 Section 5.16 Counterparts; Effectiveness 17 EXHIBIT A JOINDER AGREEMENT 21 INDEX OF DEFINED TERMS Term Section Acquisition Proposal 4, 5 Additional Shares 4 Affiliate 3 Agreement 3 Bankruptcy and Equity Exception 7 Beneficial Owner 4 Beneficial Ownership 4 Beneficially Own 4 Beneficially Owned 4 Company T 3 Company T ADSs 4 Company T Shareholder 3 Company T Shares 4 Company Y 3 control 4 controlled by 4 controlling 4 Covered Shares 5 Effective Time 7 Exchange Act 4 Existing Shares 5 Governmental Entities 8 Merger 3 Merger Agreement 3 Merger Sub 3 Permitted Transfer 5 Transfer 5 under common control with 4 VOTING AGREEMENT VOTING AGREEMENT, dated as of March 11, 2012 (this “Agreement”), by and among Youku Inc., an exempted company with limited liability incorporated under the laws of the Cayman Islands (“Company Y”), and the Person listed on Schedule 1 hereto (the “Company T Shareholder”).

  • Captions; Table of Contents The captions or headings in this Agreement and the Table of Contents are for convenience only and in no way define, limit or describe the scope and intent of any provisions of this Agreement.

  • Headings; Table of Contents The headings of the sections of this Agreement and the table of contents have been inserted for convenience of reference only and shall not be deemed a part of this Agreement.

  • Table of Contents; Headings The table of contents, cross-reference sheet and headings of the Articles and Sections of this Indenture have been inserted for convenience of reference only, are not intended to be considered a part hereof and shall not modify or restrict any of the terms or provisions hereof.

  • Table of Contents, Headings, etc The table of contents and the titles and headings of the articles and sections of this Indenture have been inserted for convenience of reference only, are not to be considered a part hereof, and shall in no way modify or restrict any of the terms or provisions hereof.

  • Headings and Table of Contents The inclusion of headings and a table of contents in this Agreement are for convenience of reference only and will not affect the construction or interpretation hereof.

  • Table of Contents, Headings and Captions The table of contents, headings, subheadings and captions contained in this Agreement are included for convenience of reference only, and in no way define, limit or describe the scope of this Agreement or the intent of any provision hereof.

  • Table of Contents and Section Headings The table of contents and the Section and subsection headings herein are intended for convenience only and shall be ignored in construing this Agreement.

  • Effect of Headings and Table of Contents The Article and Section headings herein and the Table of Contents are for convenience only and shall not affect the construction hereof.

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