Quality Tests and Checks. Pfizer shall perform all bulk holding stability, manufacturing trials, validation (including, but not limited to, method, process and equipment cleaning validation), raw material, in- process, bulk finished product and stability (chemical or microbial) tests or checks required to assure the quality of the Product and tests or checks required by the Specifications and cGMP.
Quality Tests and Checks. Manufacturer shall perform all bulk holding stability, manufacturing trials, validation (including, but not limited to, method, process and equipment cleaning validation), raw material, in-process, bulk finished product and stability (chemical and/or microbial) tests or checks required to assure the quality of a given Product and any tests or checks required by the Specifications, the Quality Agreement, applicable Facility Addendum or applicable Laws. With respect to any Product manufactured prior to Closing or located at a Facility as of Closing, Manufacturer shall maintain, continue and complete any and all such activities, tests and checks, including, without limitation, all ongoing stability testing. All costs associated with the performance of Manufacturer’s obligations under this Section 4.6 (including with respect to any Product manufactured prior to Closing or located at a Facility as of Closing) are included in the Price of each Product and, accordingly, Manufacturer shall perform the foregoing at its cost and expense, without further reimbursement from Customer. Manufacturer shall obtain Product for these tests from batches of Product manufactured under this Agreement, and Manufacturer is responsible for providing all necessary technical, quality and operational resources. All tests and test results shall be performed, documented and summarized by Manufacturer in accordance with the Specifications, Quality Agreement, applicable Facility Addendum, applicable Laws and reasonable quality assurance requirements provided by Customer to Manufacturer in writing. Manufacturer shall maintain all production Records and disposition of each batch of Product.
Quality Tests and Checks. Quality tests and checks for the Product will be conducted in accordance with the Quality Agreement and the Product Supplement (Attachment 1).
Quality Tests and Checks. In accordance with paragraph 3.7 hereof, Wellness shall perform all in-process and tests required of its Water Technology or checks required by the Specifications, if applicable. For purposes of this Agreement, such tests shall be considered routine and shall, where internal testing is required, be performed by FCL at its facilities. All tests and test results shall be performed, documented and summarized by Wellness in accordance with the Specifications. Test results shall be reviewed by Wellness prior to release of test results to Mannatech.
Quality Tests and Checks. CID Lines shall perform all tests or checks necessary to assure the quality of the Licensed Product and any tests or checks required by the Specifications, applicable laws, rules and regulations or as reasonably requested by the Company. For purposes of this Agreement, all such tests shall be considered routine and shall be performed at CID Lines' expense. All tests and test results shall be performed, documented and summarized by CID Lines in accordance with applicable law. [suggested revised language inserted in Section 5.07]
Quality Tests and Checks. Sharp shall perform all in-process and finished product tests or checks necessary to assure the quality of the Packaged Products and any tests or checks required by the Specifications or Applicable Law. For purposes of this Agreement, such tests shall be considered routine and shall be performed at Sharp’s expense. All tests and test results shall be performed, documented and summarized by Sharp in accordance with the Specifications and Applicable Law. The parties hereto will negotiate in good faith any unanticipated burdens resulting from changes made to any Applicable Law after the date hereof.
Quality Tests and Checks. In order to assure the conformity of the Products to the Specifications, the Supplier shall deliver or cause to be delivered to CUTANEA, at the time of shipment, a certificate of analysis and compliance or other batch documentation upon reasonable request (such as, deviations, investigations, batch records) with respect to each batch of Product supplied hereunder in the form required by the Quality Agreement.
Quality Tests and Checks. Orchid, at its expense, shall perform all stability, validation, API and other raw material and in-process and finished product tests or checks required by the Specifications and Applicable Laws in order to assure the conformity of the API and raw materials and the Products to the Specifications and the quality of the Products manufactured and supplied hereunder. Orchid shall supply to Alpharma a certificate of analysis and a certificate of compliance with respect to each batch of Product supplied hereunder in the form and at the time required by the Quality Agreement. Non-
Quality Tests and Checks. CEPH shall perform all stability, validation, Raw Material and in-process and finished product tests or checks required by the Specifications and Applicable Laws as set forth in Schedule B. For purposes of this Agreement, such tests and/or checks shall be considered routine and shall be performed at CEPH’s expense. All tests and test results shall be carefully performed, documented and summarized by CEPH in accordance with the Specifications and Applicable Laws. Without limiting the foregoing, CEPH shall test and inspect each lot of the Products for compliance with the Specifications prior to release and shipment of such Products to Advancis. Each release of Products by CEPH shall include all documents specified in Section 2.4. CEPH also shall provide to Advancis all necessary material safety data sheets. [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED.
Quality Tests and Checks. Finished Product release and stability testing shall be the responsibility and at the expense of Axcan Pharma and Paddock shall not perform nor shall it have any responsibility for such finished Product release testing or stability testing. Paddock shall perform such in-process tests or checks necessary to assure the quality of the Products and any tests or checks required by the Specifications, the Quality Agreement and applicable Law The parties hereto will negotiate in good faith any unanticipated burdens resulting from changes to applicable Laws after the date hereof, which changes affect the Specifications.
