Quality Control and Assurance. Supplier shall manufacture the Products in accordance with the Specifications, Applicable Laws and with proper standards of quality control and quality assurance. Supplier shall permit Silk Road Medical or its designated representative to perform such reasonable audits and inspections as may be requested by Silk Road Medical of the facilities, procedures and records that are relevant to Supplier’s manufacturing of the Products, and to the extent reasonably obtainable by Supplier, of facilities, procedures and records that are relevant to such reasonable audits or inspections of unaffiliated parties with responsibility for testing, analyzing, labeling or packaging the Products. Supplier shall maintain such records for a period of no less than seven (7) years following the manufacture of any particular Product. Supplier shall notify Silk Road Medical immediately upon receipt of all warning letters, 483s and other correspondence with the Competent Authority, Notified Body or other governmental authority related to the Product.
Quality Control and Assurance. Eurand will manufacture the Product in compliance with the NDA, the Specifications, cGMP and the Quality Agreement. Eurand will perform quality control testing on the Product to be delivered to Reliant or the Designated Facility in accordance with the NDA, the Specifications, cGMP and the Quality Agreement.
Quality Control and Assurance. Lilly will use its Commercially Reasonable Efforts to Manufacture the Devices in compliance with the Specifications. Lilly will perform quality control testing and quality oversight on the Devices to be delivered to Amylin hereunder in accordance with the MRD, Quality Agreement, Specifications, cGMP and cQSRs.
Quality Control and Assurance. Quality Control - The device shall incorporate a mechanism which enables the operator to perform a validation check before each test to verify that the device and all its associated components are working. It shall be possible to perform a regular test to check that the device is correctly calibrated. Quality Assurance - it shall be possible to perform a self-check of all electrical devices before each test to ensure that they are functioning correctly.
Quality Control and Assurance. Company shall establish and maintain a Quality Control Plan (“QC Plan”) to ensure that Company meets or exceeds the requirements of this Agreement. Company’s QC Plan shall be subject to Xxxxxx’x approval and Xxxxxx may evaluate all elements of Company’s actual performance during the Term to ensure that the specifications and other conditions of this Agreement are being met.
Quality Control and Assurance. Alien shall perform such quality control and quality assurance tests and procedures as are required to ensure the Products meet the Specifications or as may be mutually agreed between the parties hereafter. Upon completion of the manufacture of each shipment lot of Products, Alien shall provide Buyer with a written report of the results of said quality control and quality assurance tests and procedures with respect to that shipment lot. It is understood that, for all purposes, Buyer may rely on said written report of results of quality control and quality assurance tests and procedures.
Quality Control and Assurance. (a) Lilly shall ----------------------------- manufacture the Product in compliance with the NDA and in accordance with all Applicable Laws including, where required, Good Manufacturing Practices and the related provisions of the Federal Food, Drug and Cosmetic Act. Lilly shall perform quality control and quality assurance testing on Product to be delivered to JMED hereunder in accordance with the Specifications and the Requirements Document.
Quality Control and Assurance. Lilly will manufacture the Marketed Product in compliance with the Specifications. Lilly will perform quality control and quality assurance testing on the Marketed Product to be delivered to ViroPharma hereunder in accordance with the Specifications, cGMP and the MRD/Quality Agreement.
Quality Control and Assurance. The Parties shall enter into an appropriate Quality Agreement contemporaneously with this Agreement and shall comply with their respective obligations therein. PATHEON will perform the quality control and quality assurance testing and other activities specified in the Quality Agreement. Release to RELYPSA will be the responsibility of PATHEON. PATHEON will perform its Release responsibilities in accordance with PATHEON’s standard operating procedures and the Quality Agreement. For each Batch, a certificate of analysis and certificate of compliance will be delivered to RELPSA that includes a statement that the Batch of Bulk or Finished Product, as applicable, has been manufactured and tested in [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. accordance with Specifications, the Master Batch Record, PATHEON’s standard operating procedures and cGMP and meets the applicable Specifications. PATHEON will give RELYPSA copies of the Batch records for [***] Batches and complete Batch records for Batches [***] Batch will be provided to RELYPSA upon request. The form and style of Batch documents, including [***] are the exclusive property of PATHEON. The information about API, Bulk and Finished Product contained in those Batch documents and other records is RELYPSA’s exclusive property and RELYPSA Confidential Information.
Quality Control and Assurance. VGX shall manufacture Product in compliance and in accordance with the Specifications and all applicable laws and regulations. Prior to each shipment of Product, VGX shall perform quality control testing on Product in accordance with Specifications as outlined in the Purchase Order. VGX shall, during and after the term of this Agreement, maintain such records and data that document its compliance with this Section 4.2 as is required by law and regulation applicable to the manufacture of the Product. In performing its obligations under this Agreement, VGX shall comply with all applicable environmental and health and safety laws. VGX shall be solely responsible for determining how to carry out these obligations.
