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. (a) Patheon shall manufacture, package, test and ship the Products in accordance with (i) the current good manufacturing practices as described in Division 2 of Part C of the Food and Drug Regulations (Canada) and Parts 210 and 211 of Title 21 of the United States Code of Federal Regulations, together with the latest Health Canada and FDA guidance documents pertaining to manufacturing and quality control practices all as updated, amended and revised from time to time (collectively “GMPs”), and (ii) the Specifications. Patheon’s responsibilities and obligations described in the foregoing sentence are hereinafter referred to as the “Patheon Manufacturing Requirements”.
(b) Patheon shall perform the quality control and quality assurance testing specified in the Quality Agreement.
(c) If the Products as manufactured by Patheon do not satisfy Patheon’s quality control and quality assurance testing due to Patheon’s failure to produce the Products in accordance with the Patheon Manufacturing Requirements, Patheon shall, at its sole cost and expense, manufacture additional Products to replace such defective Products. In such circumstances, Client shall have no obligation to purchase or pay for any rejected Products.
(d) Notwithstanding any provisions of this Agreement to the contrary, the parties agree that Patheon shall not be liable or have any responsibility for any deficiencies in, or other liabilities associated with: (i) the formulae and procedures specified by Client; (ii) the safety (except to the extent due to the fault of Patheon as determined in accordance with the provisions of this Agreement), efficacy or marketability of the Products; (iii) distribution risk; (iv) Components, provided that any such deficiency was not reasonably discoverable using the test methods detailed in the Specifications and applying such test methods in accordance with GMP; or (v) services provided by third parties in connection with the packaging of the bulk Product.
(e) Each time Patheon ships Products to Client, it shall provide Client with a certificate of analysis that sets out the actual test results for each lot of Products and which certifies that the Products shipped to Client have been evaluated by Patheon’s Quality Control/Quality Assurance department and that the Products comply with the Patheon Manufacturing Requirements. * Redacted text has been omitted and filed separtely pursuant to a request for confidential treatment. Patheon shall not under any circumstances...
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. 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. 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. 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. 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 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. (a) ANSYS shall manufacture the Device in accordance with the then current product specifications as set forth on Exhibit A, as may be modified from time to time in accordance with Section 1.3 above, as well as with the then current quality control specifications, which, at RDS's discretion, it may modify from time to time, subject to the reasonable approval of ANSYS. A copy of the quality control specifications will be provided by RDS within a reasonable period after execution of this Agreement and shall be attached hereto as Exhibit D.
(b) ANSYS shall manufacture the Device in compliance with all federal, state and local laws and regulations.
(c) ANSYS shall perform quality control and quality assurance testing and verification to ensure that the Device complies with the requirements set forth in Section 3.9(a) and (b).
(d) Each time ANSYS ships the Device to RDS, ANSYS shall provide RDS with a Certificate of Analysis at the time of shipment, certifying that the products have been evaluated by ANSYS's Quality Control and Quality Assurance departments and that the product complies with the requirements set forth in Sections 3.9(a) and (b). Within a reasonable period after execution of this Agreement RDS shall provide ANSYS with a sample Certificate of Analysis which ANSYS shall use pursuant to this Section.
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.
(b) Personnel from JMED shall, upon reasonable advance notice to Lilly, have access during normal business hours to Lilly's premises where the Product is being manufactured, tested, inspected, packaged and/or stored in order to observe and inspect the manufacturing, quality control and testing processes for, and the records of all production and quality assurance data related to, the Product.
