Failed Batch definition

Failed Batch means any cGMP Batch that fails to conform with the Specifications and/or is not manufactured in accordance with cGMP and/or the Quality Agreement.
Failed Batch means any batch of Product Manufactured by Regeneron or the Third Party Fill/Finish Provider that fails to generate adequate yields of Product or fails to meet quality requirements, including failure to Manufacture any Product in compliance with Specifications or applicable Good Practices, in each case which were not released by Regeneron. If a Failed Batch does not result from the gross negligence, recklessness, bad faith or intentional wrongful acts, or omissions committed by Regeneron or its Affiliates (or their respective agents, contractors, representatives or other persons or entities working on their behalf), then, to the extent such Failed Batch was Manufactured, in whole or in part to fulfill Kiniksa’s Firm Order, the costs of the Failed Batch (or a pro rata allocation thereof if the Failed Batch was not Manufactured solely to fulfill Kiniksa’s Firm Order) will be included as Manufacturing Costs of Product as set forth in the LA (in the definition of Manufacturing Costs), otherwise KINIKSA shall not be responsible for the costs of such Failed Batch.
Failed Batch means [***].

Examples of Failed Batch in a sentence

  • The Parties agree that with respect to meeting the quality and safety specifications of a Batch, a Batch that does not meet the Specifications will be deemed a Failed Batch.

  • In the event Passage Bio, at its discretion, elects to delay the restart of a Failed Batch thereby pushing out the anticipated restart date, the additional time to push out the restart shall not count against [*].

  • Customer shall notify Lonza in writing of any rejection of a Batch based on any claim that it is a Failed Batch within [Redacted] after Release, after which time all unrejected Batch(es) shall be deemed accepted.

  • Without prejudice to the indemnities set out in Section 14.1.1 (Provider Indemnification), the remedies under this Section 10.6 (Remedies) shall be Senti’s sole remedies and Provider’s sole liability in connection with any Failed Batch or Nonconforming Product.

  • Lonza shall exercise best commercial efforts to immediately reprocess or replace a Failed Batch.

  • Within the timeframe specified for inspection pursuant to Section 6.1 of this Agreement, SuperGen may inspect the submitted documentation and test API samples to determine if the API is a Failed Batch.

  • Provider shall have no obligation to remedy a Failed Batch or Product Nonconformity under this Section 10.6 (Remedies) if [***].

  • In the event of a Failed Batch due to Lonza’s breach of its obligations in this CMSA, negligence or intentional misconduct, [***].

  • In the event of a Failed Batch or a Nonconforming Product [***], subject to Section 5.4 (Supply Failure), Provider will, at Senti’s option, either (a) [***], or (b) [***]In the event of a Failed Batch or a Nonconforming Product [***], Provider will, upon Senti’s request, [***].

  • Vaxcyte shall notify Lonza in writing of any Failed Batch within [***] of Batch release, after which time an unrejected Batch shall be deemed accepted.


More Definitions of Failed Batch

Failed Batch is defined in Section 10.4 (Batch Failure).
Failed Batch shall have the meaning set out in Clause 7.3.3.
Failed Batch means any Batch (a) which does not conform to the requirements of the Specifications, or (b) fails to meet a cGMP requirement, or (c) was not Processed in accordance with the Master Production Record as allowed by cGMP, such that identity, purity, strength or potency is compromised.

Related to Failed Batch

  • Failed Bank has the meaning set forth in Recital A.

  • Spoiled ballot means each ballot that:

  • Inventories means “Inventories” as defined in the Uniform System of Accounts, such as provisions in storerooms, refrigerators, pantries and kitchens, beverages in wine cellars and bars, other merchandise intended for sale, fuel, mechanical supplies, stationery, and other supplies and similar items.

  • Account Records is defined in Section 1(a)(i) of the Administration Agreement.

  • Harvest batch means a specifically identified quantity of dried flower or trim, leaves, and other cannabis plant matter that is uniform in strain, harvested at the same time, and, if applicable, cultivated using the same pesticides and other agricultural chemicals, and harvested at the same time.

  • Client Records has the meaning set forth in Section 3.14.

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • Student Records Means both of the following: (1) Any information that directly relates to a student that is maintained by LEA and (2) any information acquired directly from the student through the use of instructional software or applications assigned to the student by a teacher or other LEA employee. For the purposes of this Agreement, Student Records shall be the same as Educational Records, and Covered Information, all of which are deemed Student Data for the purposes of this Agreement. Service Agreement: Refers to the Contract or Purchase Order to which this DPA supplements and modifies.

  • Production Period is the period that for winter cereal advances commences October 1, 2021 and terminates September 30, 2023; for advances on all other field crops, honey, hogs, goats, sheep and lambs commences April 1, 2022 and terminates September 30, 2023; and for advances on cattle, continuous flow cattle, and bison commences on April 1, 2022 and terminates on March 31, 2024.

  • Contaminated site means a site where there is a confirmed presence, caused by man, of hazardous substances of such a level that they pose a significant risk to human health or the environment taking into account current and approved future use of the land;

  • Relevant Assets means all of the following:

  • related service means any service or benefit provided or made available by an insurer or any associate of that insurer, together with or in connection with any policy or policy benefit, and includes a loyalty benefit and a no-claim bonus;

  • Eligible business means a business located within the counties of Cook, DuPage, Kane, Lake, McHenry or Will in the State of Illinois (the “Six County Region”), and as to which: (1) a majority of the business' fleet is located and used within the Six County Region; and (2) a majority of those vehicles located and used within the Six County Region are alternatively powered vehicles.

  • Inventory is all “inventory” as defined in the Code in effect on the date hereof with such additions to such term as may hereafter be made, and includes without limitation all merchandise, raw materials, parts, supplies, packing and shipping materials, work in process and finished products, including without limitation such inventory as is temporarily out of Borrower’s custody or possession or in transit and including any returned goods and any documents of title representing any of the above.

  • Product Backlog means a list of those Stories that do not form part of the current Sprint Plan at that time and which are to form the subject of a future Sprint, either in the current Release at that time or a subsequent Release;

  • gross tonnage means the gross tonnage calculated in accordance with the tonnage measurement regulations contained in Annex I to the International Convention on Tonnage Measurement of Ships, 1969 or any successor Convention.

  • Major medical equipment means medical equipment which is used for the provision of medical and other health services and which costs in excess of the capital expenditure minimum, except that such term does not include medical equipment acquired by or on behalf of a clinical laboratory to provide clinical laboratory services if the clinical laboratory is independent of a physician's office and a hospital and it has been determined under Title XVIII of the Social Security Act to meet the requirements of paragraphs (10) and (11) of Section 1861(s) of such Act. In determining whether medical equipment has a value in excess of the capital expenditure minimum, the value of studies, surveys, designs, plans, working drawings, specifications, and other activities essential to the acquisition of such equipment shall be included.

  • Analytical x-ray equipment means equipment used for x-ray diffraction or fluorescence analysis.

  • shipped includes removal from the work sites by ship or any other means;

  • Contaminated soil means soil that meets all of the following criteria:

  • Doubtful Loss", "Classified", "Criticized", "Watch list" or words of similar import, together with the principal amount of and accrued and unpaid interest on each such Loan and the identity of the obligor thereunder, (4) where a reasonable doubt exists as to the timely future collectibility of principal and/or interest, whether or not interest is still accruing or the loans are less than 90 days past due, (5) where the interest rate terms have been reduced and/or the maturity dates have been extended subsequent to the agreement under which the loan was originally created due to concerns regarding the borrower's ability to pay in accordance with such initial terms, or (6) where a specific reserve allocation exists in connection therewith, and (G) all assets classified by Innes Street or Citizens Bank as real estate acquired through foreclosure or in lieu of foreclosure, including in-substance foreclosures, and all other assets currently held that were acquired through foreclosure or in lieu of foreclosure.

  • Merchandise means any personal property offered or sold for use in connection with the funeral, final disposition, memorialization, or interment of human remains, but which is exclusive of interment rights.

  • Client Assets means assets which a bank has undertaken to hold for a client (whether or not on trust, and whether or not the undertaking has been complied with);

  • Receivables Records means (i) all original copies of all documents, instruments or other writings or electronic records or other Records evidencing the Receivables, (ii) all books, correspondence, credit or other files, Records, ledger sheets or cards, invoices, and other papers relating to Receivables, including, without limitation, all tapes, cards, computer tapes, computer discs, computer runs, record keeping systems and other papers and documents relating to the Receivables, whether in the possession or under the control of Grantor or any computer bureau or agent from time to time acting for Grantor or otherwise, (iii) all evidences of the filing of financing statements and the registration of other instruments in connection therewith, and amendments, supplements or other modifications thereto, notices to other creditors or secured parties, and certificates, acknowledgments, or other writings, including, without limitation, lien search reports, from filing or other registration officers, (iv) all credit information, reports and memoranda relating thereto and (v) all other written or nonwritten forms of information related in any way to the foregoing or any Receivable.

  • Subject Receivables has the meaning assigned to such term in the Asset Representations Review Agreement.