By Prometheus Sample Clauses
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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 S...
By Prometheus. Under the terms and subject to the conditions of this Agreement, Prometheus hereby grants GSK and its Affiliates the non-exclusive, royalty-free right under the Prometheus Intellectual Property and the Product Developments (collectively, the "Prometheus Rights") to utilize the Prometheus Rights, solely to perform GSK's obligations hereunder.
By Prometheus. If The Regents should violate or fail to perform any term or covenant of this Agreement, then Prometheus may give written notice of such default ("Notice of Default") to The Regents. If The Regents should fail to repair such default within 90 days after the date such notice takes effect, Prometheus will have the right to terminate this Agreement and the licenses herein by a second written notice ("Notice of Termination") to The Regents. If a Notice of Termination is sent to The Regents, this Agreement will automatically terminate on the date such notice takes effect. Such termination will not impair any accrued right of Prometheus. These notices will be subject to Article 15 (Notices).
By Prometheus. During the Term of this Agreement, neither Prometheus nor any of its Affiliates shall, directly or indirectly, Exploit a Significant Direct Competitor that is not a Licensed Product in the Prometheus Territory, or otherwise assist or transfer or license rights to any business that Prometheus knows intends to use such assistance or rights to Exploit a Significant Direct Competitor in the Prometheus Territory. Each of the Parties hereto recognizes that the restrictions contained in, and the terms of, this Section 2.4.2 are properly required for the adequate protection of Rosetta’s rights hereunder, and agree that if any provision in this Section 2.4.2 is determined by any court to be unenforceable by reason of its extending for too great a period of time or over too great a geographic area, or by reason of its being too extensive in any other respect, such covenant shall be interpreted to extend only for the longest period of time and over the greatest geographic area, and to otherwise have the broadest application as shall be enforceable. [***]. If Prometheus or any of its Affiliates are acquired by or merge with a Third Party that has a Significant Direct Competitor that is not a Licensed Product, neither Prometheus nor any of its Affiliates will have any obligations under this Section 2.4.2 with respect to such Significant Direct Competitor; provided that the division, subsidiary or business group of the surviving party in such change of control that pursues such Significant Direct Competitor shall not have access to, and shall not refer to, rely upon or use in any manner, the Licensed Intellectual Property with respect to such Significant Direct Competitor, except with Rosetta’s prior written consent and on the condition that such Significant Direct Competitor be treated as a Licensed Product hereunder.