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.
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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.
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Failed Batch is defined in Section 10.4 (Batch Failure).
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Examples of Failed Batch in a sentence

  • Lonza shall not be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed Batch except to the extent set forth in this Clause 7.3.3.

  • If any replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***].

  • Customer acknowledges and agrees that its [***] with respect to a Failed Batch that is a Lonza Responsibility is [***].

  • Year around subsistence resource distribution, abundance, movement and associated seasonal harvest activities could be affected by seismic exploration, exploratory drilling and infrastructure and development/production activities.

  • If any replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications due to Lonza’s Responsibility, then the Steering Committee shall decide in its sole discretion, if Lonza shall either replace such cGMP Batch or refund the amounts paid by Customer for such cGMP Batch.

  • Customer acknowledges and agrees that its sole remedy with respect to a Failed Batch that is a Lonza Responsibility is as set forth in this Clause 7.3.3, and in furtherance thereof, Customer hereby waives all other remedies at law or in equity regarding the foregoing claims.

  • 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.

  • The Government has allocated £5 million to support the Stimulating Physics Network (SPN) to reach more schools and widen participation in physics by groups that are currently under-represented, including girls and those living in disadvantaged areas.

  • Regardless of the remedy elected by Customer under this Section 7.3.3, for the purpose of calculating whether Customer has purchased the Minimum Quantity in accordance with Section 6.4, a Failed Batch shall be considered a Batch “purchased” on the Commencement Date of such Batch as specified in the Purchase Order.

  • In the event that such failure of the Failed Batch is determined by the Parties or the independent laboratory in accordance with Section 7.3.2 to be attributable to the Manufacturing Process supplied to Lonza by Customer (“AMAG Failed Batch”), then such Reprocessing, Reworking or replacement will be at [***] cost, including the cost of Raw Materials and Necessary Consumables, according to a schedule mutually agreed to by the Parties, which shall in any event be as promptly as practicable.


More Definitions of Failed Batch

Failed Batch shall have the meaning set out in Clause 7.3.3.
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Failed Batch means [***].
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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.
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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, but not limited to, provisions in storerooms, refrigerators, pantries and kitchens; beverages in wine cellars and bars; other merchandise intended for sale; fuel; mechanical supplies; stationery; and other expensed 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.

  • 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;

  • MONTHLY KILOMETREAGE STATEMENT CUM BILL means the format specified by the Company.

  • related service , means the services incidental to the supply of the Goods, such as transportation, insurance, installation, training and initial maintenance and other such obligations of the Supplier under the Contract.

  • 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.

  • patient record means a written account of all services provided to a patient by the home health agency, as well as other pertinent information necessary to provide care.

  • gross tonnage means the gross tonnage (GT) 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;

  • 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.

  • Review Receivable has the meaning designated in Section 1.02 of the Asset Representations Review Agreement.

  • 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.

  • Medical Records the Study Subjects’ primary medical records kept by the Institution on behalf of the Study Subjects, including, without limitation, treatment entries, x-rays, biopsy reports, ultrasound photographs and other diagnostic images. Zdravotní záznamy: primární zdravotní záznamy Subjektů studie vedené Zdravotnickým zařízením ve vztahu k Subjektu studie, zejména záznamy o poskytnuté péči, zázanym o RTG vyšetřeních, protokoly o provedených biopsiích, snímky z ultrazvukových vyšetření a další snímky diagnostické povahy. Study Data: all records and reports, other than Medical Records, collected or created pursuant to or prepared in connection with the Study including, without limitation, reports (e.g., CRFs, data summaries, interim reports and the final report) required to be delivered to Sponsor pursuant to the Protocol and all records regarding inventories and dispositions of all Investigational Product. Studijní data a údaje: veškeré záznamy, zprávy a protokoly, jež jsou odlišné od Zdravotních záznamů, a které jsou získány, shromážděny či vytvořeny v návaznosti na či připraveny v souvislosti se Studií, zejména zprávy, záznamy a protokoly (např., CRFs, datové přehledy, mezitímní zprávy a protokoly, a závěrečná zpráva), které jsou požadovány, aby byly poskytnuty Zadavateli v souladu s Protokolem a veškerými záznamy ohledně inventurní evidence a nakládání s veškerým množstvím Hodnoceného léčiva.

  • Product Inventory means all inventory owned as of the Closing by Seller of finished Compound or Product or works in progress or materials used in the manufacture of finished Product, whether held at a location or facility of Seller (or of any other Person on behalf of Seller, including in any of Seller’s warehouses, blenders, toll manufacturers, suppliers, distributors or consignees) or in transit to or from Seller (or any such other Person), including active pharmaceutical ingredient; provided that such Product is listed by Seller in Section 6.09 of the Seller Disclosure Schedule.

  • Contract File means with respect to each Contract, the physical and/or electronic files in which Credit Acceptance maintains the fully executed original counterpart or “authoritative copy” (in each case, for UCC purposes) of the Contract (to the extent required in accordance with Section 3.03 of this Agreement), either a standard assurance in the form commonly used in the industry relating to the provision of a certificate of title or other evidence of lien, the original or electronic instruments modifying the terms and conditions of such Contract and the original or electronic endorsements or assignments of such Contract.

  • Balance billing means charging or collecting an amount in excess of the Medicaid, Medicare, or contracted reimbursement rate for services covered under a Medicaid, Medicare or employer sponsored beneficiary’s plan. “Balance Billing” does not include charging or collecting deductibles or copayments and coinsurance required by the beneficiary’s plan.