Quality Responsibilities. Supplier's responsibility to Customer for the quality of Products sold by Supplier to Customer under this Agreement shall be limited to its obligations set forth in Subparagraphs (a) and (b) of this Paragraph 13. Anything herein to the contrary notwithstanding, Supplier shall have no responsibility to Customer for the adequacy of the Specifications.
Quality Responsibilities. 19 14. INSPECTIONS............................................................ 19
Quality Responsibilities. The activities for and associated with the Manufacturing of the Product must meet the current cGMPs as set forth in the “Code of Federal Regulations of the U.S. Food and Drug Administration”, 21 CFR Parts 210 & 211, as well as “The Rules Governing Medicinal Products in the European Community”, volume IV, “Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use”, as well as the requirements of any applicable national guidelines to which the Product has been registered. In the event of a conflict in cGMPs, the U.S. Code of Federal Regulations shall apply. BVL is responsible for review and approval of all manufacturing, testing, and support documentation executed in the Manufacture of each Batch of the Product as included or referenced in the Master Production Record and for providing formal release to Customer. Customer is responsible for further release of each Batch of the Product for commercial and any other use. Any dispute between Customer and BVL with regard to acceptance of the Product shall be subject to the procedures as set out in the Agreement between Customer and BVL. Customer’s disposition will be independent of BVL’s review and release. BVL is responsible for maintaining training records for all personnel that perform cGMP functions relating to the Manufacturing operations, including personnel in QA/QC, manufacturing, etc.
Quality Responsibilities. Wellness will ensure that the manufacture of its Water Technology is performed in accordance with all applicable requirements and internal Wellness procedures and practices. Wellness shall ensure that it maintains its facilities to comply with all laws, rules and regulations. Mannatech and Wellness will each designate contact persons relating to manufacture and quality control of the Water Technology.
Quality Responsibilities. Schedule 5.10 outlines responsibilities and key contacts for Bulk Drug Product quality and compliance related issues.
Quality Responsibilities. The activities for and associated with the manufacturing of the Product must meet the current cGMPs as set forth in the “Code of Federal Regulations of the U.S. Food and Drug Administration”, 21 CFR Parts 210 & 211, as well as “The Rules Governing Medicinal Products in the European Community”, volume IV, “Guide to good manufacturing practice for medicinal products”, as well as the requirements of any applicable national guidelines to which the Product has been registered. In the event of a conflict in cGMPs, the U.S. Code of Federal Regulations shall apply. BVL is responsible for review and approval of all manufacturing, testing, and support documentation executed in the Production of each Batch of the Product as included or referenced in the Master Batch Record and for providing formal release to Customer. Customer is responsible for further release of each Batch of the Product for commercial and any other use. Any dispute between Customer and BVL with regard to acceptance of the Product shall be subject to the procedures as set out in the Agreement between Customer and BVL. Customer’s disposition will be independent of BVL’s review and release. Quality Agreement (BVL and Theravance) [*]=CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Quality Responsibilities. In order to facilitate the Release of the Final Product in the Territory, Titan shall provide to Molteni all analytical methods regarding the quality assessment of the Semi-Finished Product (including the specification of the relevant laboratory equipment), as requested by applicable European regulators or as reasonably requested by Molteni to facilitate the Release. Molteni shall be responsible for all testing and quality assessments as required by Applicable Laws and regulations necessary for Release of the Final Product in the Territory.
Quality Responsibilities. 5.1.1 EXELIXIS shall ensure that the level of quality determined by GMP is maintained throughout the manufacturing, packaging and labeling processes.
Quality Responsibilities. Anesiva and Sagent agree on the allocation of quality responsibilities between the Parties as set forth in Exhibit B of this Agreement. Where Sagent has subcontracted operations which would be subject to this Agreement, Sagent shall ensure its subcontractor complies with the applicable terms of this Agreement.
Quality Responsibilities. 5.1.1 EXELIXIS shall ensure that the level of quality determined by GMP is maintained throughout the manufacturing, packaging and labeling processes.
5.1.2 EXELIXIS shall ensure that the level of quality determined by GMP and GDP is maintained throughout manufacturing, testing and the distribution network as set forth in the Commission Guidelines 2013/C 343/01 and any and all related Directives and applicable regulatory requirements, as may be amended from time to time.
5.1.3 Ipsen and EXELIXIS shall each be responsible for:
5.1.3.1 Approving the Quality Technical Agreement,
5.1.3.2 Ensuring that the terms of this Quality Technical Agreement are complied with,
5.1.3.3 Ensuring that the terms of this Quality Technical Agreement are performed in accordance with cGMPs, GDPs and applicable ICH Guidelines.
