Common use of By Prometheus Clause in Contracts

By Prometheus. This Quality Agreement takes the form of a detailed checklist of the activities associated with the distribution, warehousing and promotion of the Product. Responsibility for each activity is assigned to either AstraZeneca and/or Prometheus in the appropriate box in the Delegation Responsibility Checklist that follows. To facilitate routine communications between the parties, a list of contacts is provided in Attachment A. For each responsibility listed, the respective party is required to put into effect all applicable procedures and take all necessary actions to effectuate such responsibility in accordance with cGMPs and applicable local, state and federal laws. This Quality Agreement is subject to the terms of the Agreement. In the event of any inconsistency between this Quality Agreement and the Agreement, the Agreement shall control, except that any dispute arising out of or relating to this Quality Agreement (other than a dispute regarding an inconsistency as aforesaid) shall be governed by Article 7 of this Quality Agreement. Nothing in this Quality Agreement shall limit, diminish, or affect in any way a party's obligation to comply with cGMPs and applicable local, state and federal laws including, without limitation, the guidance and directives set forth in: (i) FDA regulations for current good manufacturing practices as contained in 21 CFR Parts 210, 211; ii) 21 CFR Part 11; (iii) FDA Regulatory Inspection Guides; (iv) FDA Guidance for Industry; (v) Applicable State Boards of Pharmacy; and (vi) the Prescription Drug Marketing Act, as amended. This Quality Agreement shall continue in effect until the termination of the Agreement; or such time that Prometheus no longer has the right to market, distribute, and promote the Product. Table of Contents RESPONSIBILITY DELEGATION CHECKLIST 2 1.0 REGULATORY AUTHORIZATIONS AND COMMUNICATIONS 2 2.0 GMP COMPLIANCE 2 2.1 Organization and Personnel 2 2.2 Buildings and Facilities 3 2.3 Equipment and Utility Services 3 3.0 PROCESS CONTROLS 3 3.1 PRODUCT Retains 4 3.2 Change Control 4 4.0 QUALITY ASSURANCE/CONTROL 5 4.1 Records Retention 5 4.2 Customer Complaints and Adverse Events 5 4.3 Market Actions 6 4.4 Annual Product Reviews 7 5.0 PRODUCT DISTRIBUTION 7 5.1 Stop Shipment 8 5.2 PRODUCT Disposition/Rejection/Destruction 8 6.0 ASTRAZENECA OVERSIGHT 8 6.1 Audits 8 6.2 Regulatory Inspections/Notifications 9 6.3 SITE Presence 10 6.4 Review & Revision of Quality Agreement 10 7.0 DISPUTE RESOLUTION 10 8.0 STABILITY STUDIES 10 ATTACHMENTS ROUTINE COMMUNICATION CONTACTS CHANGE REQUEST NOTIFICATION AND APPROVAL FORM REQUIREMENTS FOR CERTIFICATE OF COMPLIANCE STOP SHIPMENT ORDER DEFINITIONS Terms used and defined in the Agreement will be shown in all capital letter format within this Quality Agreement. References to specific sections of the Agreement are provided for guidance and are not intended to be exclusive references. Capitalized terms that are not otherwise defined herein shall have the meaning set forth in the Agreement. CMC—shall mean the Chemistry, Manufacturing and Controls section of the New Drug Application. CGMP—shall mean the current good manufacturing practices applicable to the manufacture, testing, packaging, storage, handling and/or transportation of the PRODUCT pursuant to all applicable laws, rules or regulations in force in the Territory including the Code of Federal Regulations Title 21.

By Prometheus. This Quality Agreement takes the form of a detailed checklist of the activities associated with the distribution, warehousing and promotion of the Product. Responsibility for each activity is assigned to either AstraZeneca and/or Prometheus in the appropriate box in the Delegation Responsibility Checklist that follows. To facilitate routine communications between the parties, a list of contacts is provided in Attachment A. For each responsibility listed, the respective party is required to put into effect all applicable procedures and take all necessary actions to effectuate such responsibility in accordance with cGMPs and applicable local, state and federal laws. This Quality Agreement is subject to the terms of the Agreement. In the event of any inconsistency between this Quality Agreement and the Agreement, the Agreement shall control, except that any dispute arising out of or relating to this Quality Agreement (other than a dispute regarding an inconsistency as aforesaid) shall be governed by Article 7 of this Quality Agreement. Nothing in this Quality Agreement shall limit, diminish, or affect in any way a party's obligation to comply with cGMPs and applicable local, state and federal laws including, without limitation, the guidance and directives set forth in: (i) FDA regulations for current good manufacturing practices as contained in 21 CFR Parts 210, 211; ii) 21 CFR Part 11; (iii) FDA Regulatory Inspection Guides; (iv) FDA Guidance for Industry; (v) Applicable State Boards of Pharmacy; and (vi) the Prescription Drug Marketing Act, as amended. This Quality Agreement shall continue in effect until the termination of the Agreement; or such time that Prometheus no longer has the right to market, distribute, and promote the Product. Table of Contents RESPONSIBILITY DELEGATION CHECKLIST 2 1.0 REGULATORY AUTHORIZATIONS AND COMMUNICATIONS 2 2.0 GMP COMPLIANCE 2 2.1 Organization and Personnel 2 2.2 Buildings and Facilities 3 2.3 Equipment and Utility Services 3 3.0 PROCESS CONTROLS 3 4 3.1 PRODUCT Retains 4 3.2 Change Control 4 4.0 QUALITY ASSURANCE/CONTROL 5 4.1 Records Retention 5 4.2 Customer Complaints and Adverse Events 5 4.3 Market Actions 6 4.4 Annual Product Reviews 7 5.0 PRODUCT DISTRIBUTION 7 5.1 Stop Shipment 8 7 5.2 PRODUCT Disposition/Rejection/Destruction 8 6.0 ASTRAZENECA OVERSIGHT 8 6.1 Audits 8 6.2 Regulatory Inspections/Notifications 9 6.3 SITE Presence 10 6.4 Review & Revision of Quality Agreement 10 7.0 DISPUTE RESOLUTION 10 8.0 STABILITY STUDIES 10 ATTACHMENTS ROUTINE COMMUNICATION CONTACTS CHANGE REQUEST NOTIFICATION AND APPROVAL FORM REQUIREMENTS FOR CERTIFICATE OF COMPLIANCE STOP SHIPMENT ORDER DEFINITIONS Terms used and defined in the Agreement will be shown in all capital letter format within this Quality Agreement. References to specific sections of the Agreement are provided for guidance and are not intended to be exclusive references. Capitalized terms that are not otherwise defined herein shall have the meaning set forth in the Agreement. CMC—shall mean the Chemistry, Manufacturing and Controls section of the New Drug Application. CGMP—shall mean the current good manufacturing practices applicable to the manufacture, testing, packaging, storage, handling and/or transportation of the PRODUCT pursuant to all applicable laws, rules or regulations in force in the Territory including the Code of Federal Regulations Title 21.