Specifications; Testing. All Clinical Material supplied hereunder shall conform to the Specifications, and Biocon shall verify such conformity in accordance with the testing standards and procedures specified in the Quality Agreement. Biocon will test each Batch of Clinical Material to be delivered hereunder and supply Equillium with a Certificate of Analysis and a Certificate of Compliance. Equillium shall have the right to rely upon the Certificate of Analysis and the Certificate of Compliance provided by Biocon.
Specifications; Testing. Xxxxxx Xxxxx will perform standard analytical testing that is mutually acceptable to the parties on each lot of API prior to shipment. Xxxxxx Xxxxx shall provide a Certificate of Analysis to Cypress or its designated agent with each shipment of the API supplied hereunder. Such Certificate of Analysis shall certify with respect to each shipment and lot (identified by batch or lot number): (a) the quantity of the shipment, and (b) that the API delivered was manufactured in accordance with the API Specifications and in conformance with current good manufacturing practices (cGMPs), as well as any further information required by the relevant regulatory authorities that Cypress may have previously notified Xxxxxx Xxxxx is necessary. Cypress shall be under no obligation to accept any shipment of the API without an accompanying Certificate of Analysis.
Specifications; Testing. Subject to Section 9 below, CMO shall Manufacture Biologic that will conform to the Specifications for such Biologic as set forth in the applicable SOW or Quality Agreement or any Change Orders or amendments thereto. CMO shall test each Batch in accordance with the Specifications set forth in the applicable SOW or Quality Agreement (if applicable) and supply Client with batch-specific documentation (“Batch Documentation”) to be specified in the applicable Quality Agreement and which includes, but is not limited to: (a) a Certificate of Analysis for such Batch; (b) if such Batch is a GMP Batch, a Certificate of Compliance for such GMP Batch; (c) a summary report regarding the manufacture of such Batch in CMO’s standard form; and (d) other Batch-specific documents including analytical records (Quality Control), packaging records, material and component release records, master label templates, packaging configurations, etc. Batch Documentation shall be provided to Client at least 10 days prior to delivery of the Batch as set forth below in Section 5.2. Client shall take full responsibility for the suitability of the Specifications for Manufacturing a Biologic which possesses all desired characteristics and is suitable for the Manufacture of Client Product. CMO assumes no responsibility for any deficiency of the Specifications in this regard.
Specifications; Testing. In the event that the Specifications include a functional requirement requiring in accordance with Standard Operating Procedures an assay utilizing any reagent that is generally commercially available from TWTI or otherwise not available from any Third Party, then TWTI shall provide, at no charge to ACLA, reasonable quantities of such reagents to perform such assay reasonably sufficient for ACLA to analyze shipments of Cleavage Enzyme to ACLA for conformance with Specifications hereunder. If TWTI does not provide such reagents for any particular shipment of Cleavage Enzymes hereunder, then such shipment shall be deemed to fail such functional requirement. Likewise, if the Specifications include a functional requirement requiring in accordance with Standard Operating Procedures an eTag Functional Assay (as defined in Section 2.4(e) above), then ACLA shall provide, at no charge to TWTI, such software and reasonable quantities of such reagents reasonably sufficient for TWTI to perform such eTag Assay to analyze Cleavage Enzyme for shipment to ACLA for conformance with Specifications hereunder. If ACLA does not provide such software or reagents for quantities of Cleavage Enzyme to be supplied hereunder, then such functional requirement shall be deemed to be excluded from the Specification for such quantities. Reagents and software provided by one Party to the other Party pursuant to this Section 2.8(b) shall be used solely by the receiving Party for purposes of analyzing Cleavage Enzyme to be supplied or supplied hereunder, as applicable, for conformance with the applicable Specifications and for no other purpose.
Specifications; Testing. Supplier shall perform Manufacturing process verification and validation of the Products, as well quality control testing and quality oversight on Products to be delivered to Buyer or its designee hereunder, in accordance with the Specifications and cGMP. Products supplied hereunder will conform to the Specifications. The parties agree that, should Buyer wish to implement any amendment to the Specifications, Buyer shall provide written notice thereof to Supplier for Supplier’s review and approval, which approval shall not be unreasonably withheld, delayed or conditioned. The parties acknowledge that the Specifications may need to be refined and modified as the parties gain experience with the manufacture, testing and use of the Products. Accordingly, Buyer and Supplier agree to negotiate in good faith to modify the Specifications from time to time as the parties’ experience with the manufacture, testing and use of the Products warrants. Supplier further agrees that it will facilitate changes to the Specifications that are necessary or appropriate in light of FDA or other regulatory requirements as updated by Buyer from time to time. The parties agree to allocate on an equitable basis any special costs of developing and implementing revised procedures.
Specifications; Testing. 6.1 MPX shall cause the System to satisfy the specifications set forth in Exhibit B. MPX and SouthernNet may from time to time review these --------- specifications and make modifications thereto by written consent; provided, however, that nothing contained in this Section or in Exhibit B shall permit MPX --------- to provide to SouthernNet a System operating at performance standards lower than those imposed on SouthernNet by a state or federal regulatory authority having subject matter jurisdiction.
6.2 Upon written notice by SouthernNet to MPX requesting such testing, MPX shall perform, or shall cause the Utility Companies to perform performance or service tests beyond those tests required for the normal maintenance, restoration, and fault isolation on the System. If such requested testing reveals no deficiencies in the System, then SouthernNet shall reimburse MPX for the cost of such testing.
6.3 MPX shall provide, or shall cause the Utility Companies to provide appropriate alarm monitoring and test equipment, spare parts, and qualified personnel to properly maintain the System. Upon the request of MPX, SouthernNet agrees to perform joint testing on an as-requested basis within four (4) hours of any such request. MPX and SouthernNet shall provide each other a technical contact (including name, address, office and home telephone numbers) for coordination of testing covered under this Agreement. Two
Specifications; Testing. (a) If Buyer provides the formulas, formulations and/or specifications for blending or manufacture of the Deliverables (collectively, “Specifications”), Buyer represents and warrants to Seller that the Specifications are complete, accurate, and free from any error or defect.
(b) Xxxxx acknowledges that various factors outside of Seller’s control may affect the final content and formulation of the Goods. As a result, Seller reserves the right to test (or have a third-party designated by Seller test) the Goods prior to delivery to determine whether the Goods conform to the Specifications. Seller will provide Buyer with copies of any Certificates of Analysis generated as a result of such testing. In addition, Xxxxxx will notify Buyer in writing if testing reveals any discrepancies between the final formulation of the Goods and the Specifications (each, a “Deviation). Notwithstanding anything in this Agreement to contrary, Seller shall not be deemed in breach of this Agreement in the event of a Deviation unless the Deviation resulted solely from Seller’s reckless or willful misconduct. For the avoidance of doubt, Deviations resulting from naturally occurring variations in raw materials or from new or untested ingredient formulations and/or blending procedures will be considered to be outside of Seller’s reasonable control.
(c) If, after notification from Seller, Xxxxx wishes to take delivery of any Goods subject to Deviation, Buyer will notify Seller of such fact in writing and Xxxxx agrees to defend with counsel acceptable to Seller, indemnify and hold Seller and its owners, members, managers, officers, employees, representatives, successors and assigns harmless from and against all claims, actions, causes of action, proceedings, lawsuits, losses, injuries, damages, liabilities, costs and/or expenses (which include actual attorneys’ fees and other litigation expenses) arising from or connected with the Deviations (individually, a “Claim” and collectively, the “Claims”), including, without limitation, any Claim for recall, bodily injuries, discrepancies between the Goods and their labels and/or packaging, nutritional content claims, or failure of the Goods and/or their labels or packaging to comply with applicable law as a result of the Deviations. Buyer shall not, in the defense of any Claim, consent to entry of any judgment, award, stipulation or order, or enter into any settlement, except with the prior written consent of Seller. If, upon written notice fro...
Specifications; Testing. Pierre Fabre will perform standard analytical testing that is mutualxx xxxxxxxxxe to the parties on each lot of API prior to shipment. Pierre Fabre shall provide a Certificate of Analysis to Cypress or ixx xxxxxxxxxd agent with each shipment of the API supplied hereunder. Such Certificate of Analysis shall certify with respect to each shipment and lot (identified by batch or lot number): (a) the quantity of the shipment, and (b) that the API delivered was manufactured in accordance with the API Specifications and in conformance with *Confidential Treatment Requested
Specifications; Testing. For Work Orders for GMP Manufacturing, WuXi ATU shall Manufacture Product in accordance with the Batch Records and assess (through testing and Batch record review) whether such Product conforms to the Specifications established for such Product and as set forth in the applicable Work Order.
Specifications; Testing. (a) Batch Testing. MannKind will have standard analytical testing performed on each Manufactured batch of Product to be shipped to Sanofi to verify that it meets Product Specifications, according to the procedure described in the corresponding documentation, and that Product was Manufactured in accordance with Applicable Laws.
