Replacement Batches Sample Clauses

Replacement Batches. (a) In the event a Disputed Batch is determined to have failed the applicable Finished Product Specifications (“Nonconforming Batch”), the whole of such Nonconforming Batch shall be either returned to Protiva or destroyed, at Dicerna’s option and, if returned pursuant to Section 4.11(b) or 4.11(d), at Protiva’s expense. ***** THE COMPANY HAS REQUESTED AN ORDER FROM THE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”.
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Replacement Batches. Whether or not DOTTIKON accepts PCYC's basis for rejection of a Batch under Section 4.2, promptly following receipt of a notice of such rejection and receipt of the applicable PCYC Materials from PCYC, DOTTIKON shall use its best efforts at PCYC's written request to replace such rejected Batch. PCYC shall purchase such replacement Batch at the applicable Purchase Price, subject to its acceptance of such Batch pursuant to Section 4.2.
Replacement Batches. Whether or not LONZA accepts PCYC's basis for rejection of a Batch under Section 4.2, promptly following receipt of a notice such rejection and receipt of the applicable PCYC Materials from PCYC, LONZA shall use its best efforts at PCYC's written request to replace such rejected Batch. PCYC shall purchase such replacement Batch at the applicable Purchase Price, subject to its acceptance of such Batch pursuant to Section 4.2.
Replacement Batches. Whether or not XXXXX accepts PCYC's basis for rejection of a Batch under Section 4.2, promptly following receipt of a notice of such rejection and receipt of the applicable PCYC Materials from PCYC, XXXXX shall use its reasonable commercial efforts at PCYC's written request to replace such rejected Batch. PCYC shall purchase such replacement Batch at the applicable Purchase Price, subject to its acceptance of such Batch pursuant to Section 4.2.
Replacement Batches. 5.3.1 Whether or not Contractor accepts PCYC's basis for rejection under Section 5.2, promptly on receipt of a notice of rejection of a Batch and receipt of API from PCYC, Contractor shall use reasonable efforts at PCYC's written request to replace such rejected Batch, and PCYC shall purchase such replacement Batch at the applicable Purchase Price, subject to its acceptance of such Batch pursuant to Section 5.2. If Contractor does not accept PCYC's basis for such rejection, then Contractor shall initially bear the expenses of the independent third party laboratory or consultant described in Section 5.2.2(b), subject to Section 5.2.2(b)(iii). 5.3.2 In the event that Contractor does not give PCYC written notice, within fifteen (15) days of its receipt of PCYC's written request, that it will be able to replace such rejected Batch within a period of time reasonably acceptable to PCYC, the Secondary Source Contract Requirements shall be increased by the amount of such Batch, and the Primary Contract Source Requirements for such Drug Product for that Calendar Year shall be commensurately reduced. Notwithstanding the foregoing, if it is subsequently determined pursuant to Section 5.2.2 that the rejected Batch does conform to the applicable Specifications, then the Secondary Source Contract Requirements shall be reduced, and the Primary Source Contract Requirements shall be increased, by the amount of such Batch; provided that PCYC's purchase of a replacement Batch from a Secondary Source shall not be deemed a breach of this Agreement.
Replacement Batches. 21 5.4 Destruction of Drug Product..................................................21 5.5 Delivery of Drug Product.....................................................21 5.6 PCYC Component Non-Conformity................................................21 ARTICLE 6 QUALITY ASSURANCE; REGULATORY ....................................................22

Related to Replacement Batches

  • REPAIRED OR REPLACED PARTS / COMPONENTS Where the Contractor is required to repair, replace or substitute Product or parts or components of the Product under the Contract, the repaired, replaced or substituted Products shall be subject to all terms and conditions for new parts and components set forth in the Contract including Warranties, as set forth in the Additional Warranties Clause herein. Replaced or repaired Product or parts and components of such Product shall be new and shall, if available, be replaced by the original manufacturer’s component or part. Remanufactured parts or components meeting new Product standards may be permitted by the Commissioner or Authorized User. Before installation, all proposed substitutes for the original manufacturer’s installed parts or components must be approved by the Authorized User. The part or component shall be equal to or of better quality than the original part or component being replaced.

  • Nonconforming Work 5.6.1 Rejection, Removal and Replacement of Nonconforming Work

  • Non-Conforming Product (a) In the event Patheon discovers a potential Non-Conforming Product prior to delivery of such Product to Flexion, Patheon shall provide written notice to Flexion as soon as practicable describing in detail the Non-Conforming Product and the potential cause of such Non-Conforming Product. Flexion (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will not be obliged to perform any testing of the Product. Flexion shall within (i) […***…] days after delivery thereof by Patheon or (ii) within […***…] days after Flexion discovers or is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of such Non-Conforming Product, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon shall have no liability under this Section 2.8 for Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day period. (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] days after either discovery of the Non-Conforming Product or receipt of such Deficiency Notice from Flexion, as applicable. Such notification shall include Patheon’s good faith determination of the cause of the Non-Conforming Product.

  • 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 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.

  • Replacement Parts Replacement parts for goods purchased by Buyer are for the purpose of this Section defined as “Parts” (and are also considered “goods” under this Order). Unless specified otherwise by Buyer in writing, Supplier shall provide Parts (or upon Buyer’s written consent, an alternative replacement part that provides the same form, fit and function as the Part(s)) for a period of twenty (20) years after production of the goods (into which the applicable Parts are incorporated) ceases. Supplier shall continue to supply such Parts past the twenty (20) year period if Buyer orders at least twenty (20) Parts per year during such twenty-year period. The prices for any Parts purchased in the first two (2) years of the twenty-year period shall not exceed those prices in effect at the time production of the goods ceases, and no set up charges shall be permitted by Supplier or paid by Xxxxx during this two-year period. Thereafter, the prices for Parts shall be negotiated based on Supplier’s actual cost of production of such Parts plus any special packaging costs. No minimum order requirements shall apply unless the parties mutually agree in advance. After the end of the twenty-year period, Supplier shall continue to maintain in good working condition all Supplier-owned tooling required to produce the Parts and shall not dispose of such tooling without offering Buyer the right of first refusal to purchase such tooling.

  • RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.

  • Benchmark Replacement Conforming Changes In connection with the use, administration, adoption or implementation of a Benchmark Replacement, the Administrative Agent will have the right to make Conforming Changes from time to time and, notwithstanding anything to the contrary herein or in any other Loan Document, any amendments implementing such Conforming Changes will become effective without any further action or consent of any other party to this Agreement or any other Loan Document.

  • Replacement The term “

  • Replacement Parts Warranty If during the regular or extended warranty period’s faults develop, the Contractor shall promptly repair or, upon demand, replace the defective unit or component part affected. All costs for labor and material and transportation incurred to repair or replace defective Product during the warranty period shall be borne solely by the Contractor, and the State or Authorized User shall in no event be liable or responsible therefor. Any part of component replaced by the Contractor under the Contract warranty shall be replaced at no cost to the Authorized User and guaranteed for the greater of: a) the warranty period under paragraph (d) above; or b) if a separate warranty for that part or component is generally offered by the manufacturer, the standard commercial warranty period offered by the manufacturer for the individual part or component.

  • Bidder Supplied Samples The Commissioner reserves the right to request from the Bidder/Contractor a representative sample(s) of the Product offered at any time prior to or after award of a contract. Unless otherwise instructed, samples shall be furnished within the time specified in the request. Untimely submission of a sample may constitute grounds for rejection of Bid or cancellation of the Contract. Samples must be submitted free of charge and be accompanied by the Bidder’s name and address, any descriptive literature relating to the Product and a statement indicating how and where the sample is to be returned. Where applicable, samples must be properly labeled with the appropriate Bid or Contract reference. A sample may be held by the Commissioner during the entire term of the Contract and for a reasonable period thereafter for comparison with deliveries. At the conclusion of the holding period the sample, where feasible, will be returned as instructed by the Bidder, at the Bidder’s expense and risk. Where the Bidder has failed to fully instruct the Commissioner as to the return of the sample (i.e., mode and place of return, etc.) or refuses to bear the cost of its return, the sample shall become the sole property of the receiving entity at the conclusion of the holding period.

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