Quality Responsibilities Table. Table Key: N = Not Applicable § Responsibilities No Wyeth Supplier
Quality Responsibilities Table. The detailed listing of activities associated with manufacture, supply, analysis, and release of Product(s), specifying the respective individual responsibilities of the Parties is attached hereto as appendix 1.
Quality Responsibilities Table. Unless otherwise indicated, responsibility for each activity is assigned to either PCI, or Customer, or is assigned to both PCI and Customer. Table Key: N = Not Applicable C= Customer S = PCI (Supplier) § Responsibilities N C S A. Compliance Requirements
Quality Responsibilities Table. Responsibilities Pfizer Contractor Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of 11 pages were omitted. [**] CONFIDENTIAL Controlled ActiveUS 167576635v.1 Execution Version APPENDIX 1: Definition of Product, Materials or Service X Services. CTM = Clinical Trial Material X Services. CTM = Clinical Trial Material CTM – Drug Substance Manufacture Laboratory - Analytical Biological X [**] X Drug Substance X [**] X [**] X [**] X [**] X [**] X [**] X [**] NOTE: Contractor to inform Pfizer Quality Assurance if changes need to be made to this appendix. CONFIDENTIAL Controlled ActiveUS 167576635v.1 Execution Version APPENDIX 2: Contacts and Responsibilities CONTACT PERSON (S) FOR NOTIFICATIONS REQUIRED IN QUALITY RESPONSBILITIES TABLE CONTRACTOR PFIZER QUALITY ASSURANCE QUALITY ASSURANCE Name [**] [**] Title [**] [**] Phone [**] [**] Address (mail/delivery) [**] [**] E-mail [**] [**] BUSINESS MANAGER BUSINESS MANAGER Name [**] [**] Title [**] [**] Phone [**] [**] Address (mail/delivery) [**] [**] E-mail [**] [**] Contact Person for Notices, including notices of Changes, Assignment, Termination, & Resolution of Quality Issues Head of Quality Organization or equivalent CONTRACTOR PFIZER Name [**] [**] Title [**] [**] Phone [**] [**] Address (mail/delivery) [**] [**] E-mail [**] [**] CONFIDENTIAL Controlled ActiveUS 167576635v.1 Execution Version NOTE: Contractor to inform Pfizer Quality Assurance if changes need to be made to this appendix. CONFIDENTIAL Controlled ActiveUS 167576635v.1 Execution Version APPENDIX 3: Examples of Significant Deviations Requiring Notification to Pfizer Significant Deviations that require notification to PharmSci (minimum expectations) [**] Significant Deviations List of specific examples (but not limited to) [**] • [**] • [**] [**] • [**] • [**] [**] • [**] • [**] [**] • [**] • [**] CONFIDENTIAL Controlled ActiveUS 167576635v.1 Execution Version APPENDIX 4: Change Control Notification Guidelines [**]. Examples of Changes that Do Require Notification to Pfizer (but not limited to): Examples of Changes that Do NOT Require Notification to Pfizer: [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] CONFIDENTIAL Controlled ActiveUS 167576635v.1 Execution Version
Quality Responsibilities Table. Responsibilities Client Supplier
Quality Responsibilities Table. Responsibilities Not Applicable BioPharmX UPM
Quality Responsibilities Table. Note: if inconsistencies exist between the text of the Quality Agreement and this table, the text of the Quality Agreement takes precedent. Responsibilities XERIS PYRAMID A Compliance Requirements
Quality Responsibilities Table. A. Compliance Requirements
Quality Responsibilities Table. Table Key: N = Not Applicable § Responsibilities N Transcept Sharp [***] [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. § Responsibilities N Transcept Sharp [***] [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. § Responsibilities N Transcept Sharp [***] [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. § Responsibilities N Transcept Sharp [***] [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. § Responsibilities N Transcept Sharp [***] [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. § Responsibilities N Transcept Sharp [***] [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. § Responsibilities N Transcept Sharp [***] [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. § Responsibilities N Transcept Sharp [***] [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. § Responsibilities N Transcept Sharp [***] [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. APPENDIX 1: (Contacts and Responsibilities) Sharp Transcept Quality Assurance Quality Assurance Name Xxxxxx Harakai Xxxxx Xxxxxxxxx Title Director of Quality Assurance Associate Director, Quality Systems Phone/Fax 000-000-0000/000-000-000...
