PPQ Batches Sample Clauses

PPQ Batches. Lonza shall manufacture and deliver PPQ Batches sufficient to document the operability and reproducibility of the Manufacturing Process and permit the Parties to complete and file the necessary regulatory documents.
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PPQ Batches. If it is determined that a process performance qualification (“PPQ”) Batch does not meet the Product specifications set forth in the master batch record (“Specifications”) as a result of Service Provider’s failure to follow cGMP, then Service Provider shall, at AstraZeneca’s request and option, and as AstraZeneca’s sole and exclusive remedy (subject to Clause 12.5.5), and as soon as it is commercially practical to do so following receipt of any required materials at Service Provider’s sole cost and expense (excluding, subject to Clause 12.5.1, costs or expenses for AstraZeneca’s Materials including shipping and transport costs), either (i) re-perform such PPQ Batch; or (ii) provide AstraZeneca a credit for the amounts paid by AstraZeneca to Service Provider for such PPQ Batch. If a PPQ Batch fails to meet Specifications for any cause other than Service Provider’s gross negligence, willful misconduct or failure to follow cGMP, then Service Provider shall have no liability to AstraZeneca with respect to such Batch and AstraZeneca shall pay Service Provider for such Batch.
PPQ Batches. As requested by Company and covered in a Work Order, Supplier will produce PPQ Batches to be used in clinical trials in US and ex US. Product can be filled in either [*]or [*]. Assuming that PPQ Batches are run at Full Scale, the cost of the PPQ will be billed to Company at a rate of $[*]/[*]. If a smaller scale Batch is requested by Company, the per vial price will be adjusted appropriately. Under no circumstances will the per Batch price be less than $[*]. Testing, raw materials (excluding [*] and [*]) and Batch Record Documentation will be covered in this pricing. The cost of any required process characterization and/or process validation documentation is not covered in the per [*] pricing and will be agreed upon by the Parties in the relevant Work Order. The price of these [*] will count toward the Monthly Fees covered in Section 10.7. If the PPQ Batch Product is out-of-specification, Company will still be responsible for the price of Batch unless the root cause of the OOS is material and is directly related to Supplier’s failure to follow the manufacturing process or testing instructions that are covered in the agreed upon Batch Records or transferred test methods, respectively. For clarity, no scale-up or process characterization activities are included in the PPQ Batches. Any required scale-up or process characterization activities will be covered and agreed upon in writing by the Parties in a Work Order.
PPQ Batches. Vir will designate [***] batches from the Campaign that will be used to Manufacture process performance qualification batches (“PPQ Batches”) intended (a) [***] and (b) [***] . Vir will notify WuXi Biologics by [***] if Vir elects to Manufacture all PPQ Batches in 2020 and shall designate which Campaign batches shall be PPQ Batches. [***].

Related to PPQ Batches

  • Shipment If any of the Major Components associated with any Unit is not Shipped on or before (with the prior approval of the Buyer) the Scheduled Major Component Shipment Date set forth in Attachment 1 for reasons attributable to the Seller and not excused elsewhere in this Contract, the Seller shall pay as liquidated damages, and not as a penalty, a sum calculated in accordance with the table below for each Unit for each day of delay after the Scheduled Major Component Shipment Date as set forth in Attachment 1 until actual Shipment of the last Major Component for such Unit: Days after Scheduled Major Component Shipment Date Liquidated Damages (per day or partial day) *** *** *** *** *** *** Such liquidated damages, if any, shall be computed based on the date of Shipment of the last Major Component for a given Unit and such computations shall disregard any part of or accessory to the Major Component which may be shipped separately and arrive later unless such part of or accessory to the Major Component is necessary for the installation of the Major Component.

  • API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.

  • Product The term “

  • 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.

  • 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.

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

  • Product Recall (a) If any governmental agency with jurisdiction over the recall of any goods supplied hereunder provides written notice to Buyer or Seller, or Buyer or Seller has a reasonable basis to conclude, that any goods supplied hereunder could possibly create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a defect or a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal requirement so as to make it advisable, or required, that such goods be recalled and/or repaired, Seller or Buyer will promptly communicate such relevant facts to each other. Buyer shall determine whether a recall of the affected goods is warranted or advisable, unless Buyer or Seller has received notice to that effect from any governmental agency with jurisdiction over the recalled goods.

  • Manufacture (a) Manufacturer shall only manufacture the specific number of Products as requested by Company and at no time shall manufacture excess goods or overruns. Manufacturer shall not sell any Products bearing the Trademarks to any third parties without the express written consent of Company.

  • Product Testing Upon request, Customer shall provide Operator a laboratory report for each Product delivery by Customer or Customer’s supplier. Operator will not be obligated to receive Contaminated Product for throughput through the Pipelines, nor will Operator be obligated to accept Product that fails to meet the applicable quality specifications for the Berths under the BAUTA and any Terminal Service Orders issued thereunder.

  • Manufacturing Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Products, then Intrexon shall provide to AquaBounty or a contract manufacturer selected by AquaBounty and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty Products for use in the Field and (b) reasonably necessary to enable AquaBounty or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any AquaBounty Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty to switch manufacturers.

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