MANUFACTURING AND QUALITY CONTROL. 12.1 RTI shall establish and maintain a quality system for all stages of manufacture of the Implants, including donor eligibility and procurement of tissue, in compliance with Applicable Laws and Applicable Industry Standards, such as 21 CFR 1271, parts 820 and ISO 13485.
MANUFACTURING AND QUALITY CONTROL. 6.1 The Peretti Trademarks will not be applied to, or used in connection with the sale of, any products which have not been manufactured in strict conformance with the Peretti Designs and with the standards of quality in materials and workmanship established by Peretti and in use as of the Restatement Date.
MANUFACTURING AND QUALITY CONTROL. (1) Seller will conduct incoming quality control inspections on all Components and materials or to have such controls adequate to ensure the conformance of purchased materials and services to Seller's specifications.
MANUFACTURING AND QUALITY CONTROL. 5.1 SCHERING shall supply all raw materials and packaging components for the product of pilot batches according to specifications provided by BUYER. The pilot batches shall be manufactured in accordance with Good Manufacturing Procedures (GMP's). All pilot production is on a best efforts basis. As SCHERING has no experience with the manufacture of Product, there can be no guarantees as to the success of pilot production. SCHERING and BUYER agree that BUYER's manufacturing representative be present to review manufacturing procedures and witness the manufacture of all pilot batches.
MANUFACTURING AND QUALITY CONTROL. 5.1 For manufacture of Products, IFP shall supply all raw material and packaging components according to specifications provided by BUYER.
MANUFACTURING AND QUALITY CONTROL. 4.1Lifecore shall Manufacture the Product in accordance with the Master Services Agreement or any other subsequent written agreement executed between Lifecore and Semnur. Without limiting the scope of the foregoing in any way, Lifecore shall, among other things: · Manufacture the Product in accordance with written Batch records, the Product Specifications, Lifecore SOPs, and Applicable Law. · Validate in accordance with Applicable Law all analytical methods, equipment, Facilities, processes, computerized systems, software, and cleaning used in connection with the Manufacture of the Product. · Retain Batch documentation and maintain such other original manufacturing records as required by the Master Production Record, Lifecore SOPs, Semnur requirements and Applicable Law. · Provide adequate personnel with appropriate education, training, and experience, or any combination thereof, to Manufacture, test, and release Product and to fulfill Lifecore’s obligations under this Agreement. · Obtain and maintain during the term hereof, as relating to the Facility, all government and regulatory authority licenses, permits, registrations, and approvals required by Applicable Law in order to Manufacture the Product pursuant to the terms hereof.
MANUFACTURING AND QUALITY CONTROL. 5.1 API and Clinical Supplies delivered by Servier to XOMA shall be released by Servier’s quality control unit and shall be accompanied by a certificate of analysis and compliance signed by an authorized representative of Servier certifying that each lot of API and Clinical Supplies has been manufactured in accordance with Servier’s batch record documentation and in compliance with US cGMPs (in the case of API), EU cGMPs (in the case of Clinical Supplies), the Specifications, the Quality Agreement and the representations and warranties contained herein that relate to API or Clinical Supplies, as the case may be.
