Batch Failures Sample Clauses

Batch Failures. Bulk and Finished Product shall be produced by PATHEON in compliance with cGMP and shall conform to the Specifications as defined in the Quality Agreement and the warranties in Section 6.1. Internal process specifications will be defined and agreed upon in the Quality Agreement. If a Batch of Bulk or Finished Product is Non-Conforming and is not Released by PATHEON or is Released by PATHEON and rejected by RELYPSA in accordance with Section 8.1, and the joint investigation demonstrates or determines that PATHEON manufactured Bulk or Finished Product in compliance with cGMP, the Quality Agreement, this Agreement and PATHEON’s standard operating procedures for manufacturing and that, [***], the Non-Conformance in the Batch of Bulk or Finished Product, as applicable, is caused by defects in the API not discoverable through examination and testing required by the Quality Agreement and cGMP (a “Nonconformance Exception”), RELYPSA will pay PATHEON the applicable fee for the Batch of Non-Conforming Bulk or Finished Product, as applicable. If any Batch of Bulk or Finished Product is Non-Conforming and is not Released by PATHEON or is rejected by RELYPSA, and such Non-Conforming Batch is not a Nonconformance Exception, PATHEON shall, utilizing RELYPSA’s existing procurement and logistics process, replace the API [***], including [***], used in such Batch and either (i) promptly (subject to receipt of API) replace such Non-Conforming Bulk or Finished Product, as applicable, at PATHEON’s sole expense, including the cost of Components, or (ii), upon mutual agreement of the Parties, refund to RELYPSA or issue a credit note to RELYPSA for the Price. API in a Non-Conforming Batch shall be [***].
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Batch Failures. GSK shall pay for good in-specification batches only, delivered in accordance with the requirements of the GSK firm order and terms of the Supply Agreement.
Batch Failures. OraSure shall notify Xxxxxx as soon as practicable and in no event later than five (5) business days after discovery of any batch failure that could result in OraSure’s inability to meet Xxxxxx’x requested delivery dates. OraSure shall notify Xxxxxx as soon as practicable and in no event later than three (3) business days after any failure of a released batch of Products distributed to Xxxxxx.
Batch Failures. In the event that any run results in nonconforming Product for which Catalytica bears liability under the Agreement, such failed Batch shall be counted in determining whether the [CONFIDENTIAL TREATMENT REQUESTED] has been met hereunder, but such failed Batch shall not be counted in determining whether the [CONFIDENTIAL TREATMENT REQUESTED] has been exceeded hereunder.

Related to Batch Failures

  • Equipment Failures In the event of equipment failures beyond the Administrator's control, the Administrator shall take reasonable and prompt steps to minimize service interruptions but shall have no liability with respect thereto. The Administrator shall develop and maintain a plan for recovery from equipment failures which may include contractual arrangements with appropriate parties making reasonable provision for emergency use of electronic data processing equipment to the extent appropriate equipment is available.

  • Epidemic Failure “Epidemic Failure” for any particular Product shall mean a failure resulting from defects in material, workmanship, and manufacturing process, including but not limited to the use of Components with known defects. The Epidemic Failure clause shall be invoked [***]. The failure rate may be calculated [***], as determined by BUYER. Epidemic failures do not supersede the requirements of any expressed or implied warranty defined herein. In the case of an epidemic failure, SUPPLIER’s obligation is to propose an action plan to fix the failure of any affected Product within seventy-two (72) hours of discovery. SUPPLIER shall implement this action plan upon BUYER’s acceptance thereof. If the action plan is not acceptable to BUYER, BUYER can require SUPPLIER to repair or replace, at BUYER’s option, the affected Product. In addition to bearing the costs associated therewith, if requested by BUYER, SUPPLIER shall support and provide at SUPPLIER’s expense a sufficient number of units of the Product to permit the field exchange or “hot swap” of Products at customer sites. The parties agree to make all reasonable efforts to complete the repair or replacement of all affected Products within eight (8) Business Days after written notice of epidemic failure by BUYER to SUPPLIER. SUPPLIER also agrees that BUYER will be supported with accelerated shipments of replacement Product to cover BUYER’s supply requirements. If an Epidemic Failure is caused by (i) a design, including a BUYER-provided test process, as required by the Specifications or (ii) a failure by a Component required by the Specifications, (iii) misuse or damage during transit or damage by a third party at no fault of SUPPLIER, SUPPLIER shall perform the obligations in this Section 10.5 and BUYER shall pay to SUPPLIER the fees mutually agreed upon by the parties in writing. If an Epidemic Failure is caused by any other reason other than as set forth in the immediately preceding sentence, SUPPLIER shall perform the obligations set forth in this Section free of charge. Confidential treatment is being requested for portions of this document. This copy of the document filed as an exhibit omits the confidential information subject to the confidentiality request. Omissions are designated by the symbol [***]. A complete version of this document has been filed separately with the Securities and Exchange Commission.

  • Epidemic Failure Warranty Supplier warrants all Products against Epidemic Failure for a period of three years after DXC’s Acceptance. Epidemic Failure means the occurrence of the same failure, defect, or non-conformity with an Order in 2% or more of Products within any three-month period.

  • Power Failure Power Failure means the failure of power or other utility service if the failure takes place off the "residence premises". But if the failure results in a loss, from a Peril Insured Against on the "residence premises", we will pay for the loss caused by that peril.

  • Payment Failure Any Credit Party (i) fails to pay any principal when due under this Agreement or (ii) fails to pay, within three Business Days of when due, any other amount due under this Agreement or any other Credit Document, including payments of interest, fees, reimbursements, and indemnifications;

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Correction No corrections shall be made in the tender documents. Any corrections that are to be made shall be made by crossing the incorrect portion and writing the correct portions above with the initials of tenderer.

  • CLEC OUTAGE For a problem limited to one CLEC (or a building with multiple CLECs), BellSouth has several options available for restoring service quickly. For those CLECs that have agreements with other CLECs, BellSouth can immediately start directing traffic to a provisional CLEC for completion. This alternative is dependent upon BellSouth having concurrence from the affected CLECs. Whether or not the affected CLECs have requested a traffic transfer to another CLEC will not impact BellSouth's resolve to re-establish traffic to the original destination as quickly as possible.

  • Drug Testing (A) The state and the PBA agree to drug testing of employees in accordance with section 112.0455, F.S., the Drug-Free Workplace Act. (B) All classes covered by this Agreement are designated special risk classes for drug testing purposes. Special risk means employees who are required as a condition of employment to be certified under Chapter 633 or Chapter 943, F.S. (C) An employee shall have the right to grieve any disciplinary action taken under section 112.0455, the Drug-Free Workplace Act, subject to the limitations on the grievability of disciplinary actions in Article 10. If an employee is not disciplined but is denied a demotion, reassignment, or promotion as a result of a positive confirmed drug test, the employee shall have the right to grieve such action in accordance with Article 6.

  • Lenders’ Failure to Perform All Advances (other than Swing Loans and Agent Advances) shall be made by the Lenders contemporaneously and in accordance with their Pro Rata Shares. It is understood that (i) no Lender shall be responsible for any failure by any other Lender to perform its obligation to make any Advance (or other extension of credit) hereunder, nor shall any Commitment of any Lender be increased or decreased as a result of any failure by any other Lender to perform its obligations hereunder, and (ii) no failure by any Lender to perform its obligations hereunder shall excuse any other Lender from its obligations hereunder.

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