ACCEPTANCE AND REJECTION OF DRUG PRODUCT Sample Clauses

ACCEPTANCE AND REJECTION OF DRUG PRODUCT. 5.2.1 PCYC may reject any Batch delivered hereunder that does not conform with the applicable Project Plan, Master Batch Record, Contractor's standard operating procedures, certificate of analysis, Drug Product Specifications or Packaging Specifications (collectively, the "Specifications") based upon PCYC's testing of the QC Sample in accordance with the Testing Standards and Procedures. Any such notice of rejection shall be in writing and shall indicate the reasons for such rejection. Such notice is to be delivered to Contractor within fifteen (15) days from PCYC's receipt of the QC Sample from the designated carrier. If no such notice of rejection is received, then PCYC shall be deemed to have accepted such Batch at the end of such fifteen-day period and to have waived its right to revoke acceptance, subject to Section 7.3.
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Related to ACCEPTANCE AND REJECTION OF DRUG PRODUCT

  • Acceptance and Rejection Jubilant shall be entitled to reject any shipment of Products that fails to conform to the Product Specifications or Packaging Specifications at the time of delivery to Jubilant. Jubilant shall notify Cadista of such rejection within thirty (30) days after delivery of such Products shipment to Jubilant, and shall set forth in such notification the basis under this Agreement for such rejection, including any testing or inspection results, provided, however, that in the event any such non-conformity is latent or was not obvious and could not be readily discovered from a physical inspection of the Products shipment, Jubilant may give written notice to Cadista of its rejection of such shipment within thirty (30) days after Jubilant's discovery of such non-conformance. Failure to so notify Cadista, or failure to identify the basis under this Agreement for rejection of any Product, shall constitute acceptance of such Product, except to the extent the Product fails to conform to the Product Specifications or Packaging Specifications as the case may be. After such failure to notify, Jubilant shall be obligated to make payment for such Product in accordance with pricing provisions of this Agreement. If the parties disagree as to whether any Product meets the Product Specifications or Packaging Specifications and the parties are unable to negotiate a commercially reasonable resolution, then samples and/or batch records, as appropriate, from the disputed shipment shall promptly be submitted for testing and evaluation to an independent Third Party as shall be agreed to in writing by both parties. The determination of such Third Party as to whether the disputed Product shipment meets the Product Specifications or Packaging Specifications shall be final and binding. The cost of the testing and evaluation by the independent third party shall be borne by the party whose position is found to be erroneous. If, pursuant to this Section 3.2, any Products are found not to conform to the Product Specifications or Packaging Specifications, as a result of a cause occurring prior to placement thereof with the carrier (and not arising as a result of the Materials being defective or failing to meet their respective specifications), at Cadista’s option, Jubilant shall either (i) deliver such non-conforming Products to Cadista or (ii) destroy such non-conforming Products in accordance with applicable laws, rules and regulations. Cadista shall reimburse Jubilant for all reasonable costs and expenses in connection such delivery or destruction, and, at Cadista’s option and as Jubilant’s exclusive remedy, Cadista shall either: (i) credit Jubilant for the amount paid or payable by Jubilant to Cadista for such rejected Product shipment (and reimburse Jubilant for the Material of such rejected batch at Jubilant’s cost for such Materials), or (ii) replace such rejected Product shipment (with Cadista paying Jubilant for all Materials or such replacement shipment in an amount equal to Jubilant’s cost), at no additional cost to Jubilant, as promptly as reasonably practicable, but in no event later than forty-five (45) days from receipt of notice of non-conformity of such shipment from Jubilant. Jubilant shall notify Cadista in writing of any claim relating to quantitative deficiencies in any shipment of Product that Jubilant considers to have been caused prior to shipment hereunder within thirty (30) days following receipt of any such shipment. Any claim for a quantitative deficiency which is not made within such thirty (30) days shall be deemed to have been waived by Jubilant and Jubilant shall be obligated to make payment for such Product in accordance with Section 5 of this Agreement. In the event Jubilant determines there is a quantitative deficiency from the applicable shipping documentation, the parties shall investigate such deficiency and, if the parties agree that such deficiency occurred prior to shipment, Cadista shall, at Jubilant’s option and as Jubilant’s exclusive remedy for such quantitative deficiency, (a) credit Jubilant for the amount paid by Jubilant to Cadista in excess of the aggregate price for actual quantities shipped; or (b) subject to Cadista having Product on hand at the time of request by Jubilant, rectify any such deficiency by promptly shipping the appropriate quantities of any relevant Product to Jubilant, but in no event later than fifteen (15) calendar days following the occurrence of such a deficiency, in which case Jubilant shall be obligated to pay for any such quantities pursuant to Section 5 of this Agreement.

  • Acceptance; Rejection A holder of Notes may accept the offer to prepay made pursuant to this Section 8.3 by causing a notice of such acceptance to be delivered to the Company not later than 15 days after receipt by such holder of the most recent offer of prepayment. A failure by a holder of Notes to respond to an offer to prepay made pursuant to this Section 8.3 shall be deemed to constitute a rejection of such offer by such holder.

  • Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Non-Conforming Product If Reliant notifies Cardinal Health during the Review Period that the Manufacturing Sample does not conform to the warranty set forth in Section 13.1 and Cardinal Health agrees with Client’s determination, Client shall not be responsible to pay for such batch (the “Defective Product”), and Cardinal Health shall, at Reliant’s option, either (A) replace any Batch of non-conforming Product, or (B) credit any payments made by Reliant for such Batch. If Cardinal Health does not agree with Reliant’s determination that such Product fails to meet the warranty set forth in Section 13.1, then after reasonable efforts to resolve the disagreement, the Parties shall cause a mutually acceptable independent third party to review records, test data and to perform comparative tests and/or analyses on the Manufacturing Sample. The results of the independent review shall be final and binding. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the non-prevailing Party. THE OBLIGATION OF CARDINAL HEALTH TO (A) REPLACE DEFECTIVE PRODUCT IN ACCORDANCE WITH THE SPECIFICATIONS OR CREDIT PAYMENTS MADE BY RELIANT FOR DEFECTIVE PRODUCT AND (B) REIMBURSE RELIANT FOR API LOST IN THE DEFECTIVE BATCH, SUBJECT TO THE LIMITATIONS IN ARTICLE 15.1, SHALL BE RELIANT’S SOLE AND EXCLUSIVE REMEDY (WITHOUT PREJUDICE TO ANY INDEMNIFICATION OBLIGATIONS UNDER SECTION 14.1 OR THE OBLIGATIONS OF SECTION 10.6 (RECALL)) UNDER THIS ARTICLE FOR DEFECTIVE PRODUCT AND IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED.

  • Technical Specifications Each Bloom System is an integrated system comprised of a fuel cell stack assembly and associated balance of plant components that converts a fuel into electricity using electrochemical means that (i) has a Nameplate Capacity of at least 0.5 kilowatts of electricity using an electrochemical process and (ii) has an electricity-only generation efficiency greater than thirty percent (30%).

  • Defective Product If Client rejects Products under Section 6.1 and the deviation is determined to have arisen from Patheon’s failure to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, Patheon will credit Client’s account for Patheon’s invoice price for the defective Products. If Client previously paid for the defective Products, Patheon will promptly, at Client’s election, either: (i) refund the invoice price for the defective THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Products; (ii) offset the amount paid against other amounts due to Patheon hereunder; or (iii) replace the Products with conforming Products without Client being liable for payment therefor under Section 3.1, contingent upon the receipt from Client of all Active Materials and Client-Supplied Components required for the manufacture of the replacement Products. For greater certainty, Patheon’s responsibility for any loss of Active Materials in defective Product will be captured and calculated in the Active Materials Yield under Section 2.2.

  • Changes to Specifications All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment.

  • Quality Agreement Each Party will comply with the terms of the Quality Agreement in the performance of its obligations hereunder including record retention, audits and inspections, change control, adverse events and product recall. The Parties will conduct periodic Product quality reviews in accordance with the terms of the Quality Agreement.

  • Defective Products None of the Group Companies has manufactured, sold or supplied products which are, or were, in any material respect, faulty or defective, or which do not comply in any material respect with any representations or warranties expressly made by such Group Company, or with all applicable regulations, standards and requirements.

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