Batch Run definition

Batch Run means the production and purification process performed by ImmunoGen to generate a Batch of Drug Substance pursuant to this Agreement.
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Examples of Batch Run in a sentence

  • The Parties acknowledge that these Draft Specifications are subject to change with the collection of Batch Run manufacturing data.

  • ImmunoGen shall bear the responsibility for a failed Batch Run if such failure is attributable to the [ * ] or [ * ] of ImmunoGen.

  • ImmunoGen shall issue a written request for BIWA4 to BI Pharma (a “Shipment Order”) including, but not limited to, amount and delivery date not later than [ * ] prior to the scheduled initiation of the Batch Run.

  • If the parties, acting reasonably, are not able to agree the position on final QA release of BLA Batch Run 1 or a replacement BLA Batch Run, either party may refer the matter to an independent expert to determine whether BLA Batch Run 1 or replacement BLA Batch Run should achieve final QA release.

  • In the event that Auxilium exercises the BLA Batch Option, Auxilium shall provide written or electronic (email) notice to Cobra, and Cobra shall have ninety (90) days from the date it receives such notice to complete a new BLA Batch Run that achieves final QA release as a replacement for BLA Batch Run 1.

  • Auxilium’s right to exercise the BLA Batch Option shall expire on the earlier of (a) the date the BLA Batch Run 1 or any new BLA Batch Run achieves final QA release, or (b) December 31, 2007.

  • ImmunoGen shall issue a written request for BIWA4 to BI Pharma (a "Shipment Order") including, but not limited to, amount and delivery date not later than [ * ] prior to the scheduled initiation of the Batch Run.

  • BI Pharma shall deliver the necessary quantities of BIWA4, at BI Pharma’s sole cost, for a Batch Run no less than [ * ] days prior to the scheduled initiation of the Batch Run.

  • In the event the BLA Batch Run 1 currently in progress (Batch Identification Number CTL2006#1583I) does not achieve final QA release, Auxilium shall have the option to require Cobra to manufacture a new BLA Batch Run that achieves final QA release (hereinafter “BLA Batch Option”).

  • ImmunoGen shall bear the responsibility for a failed Batch Run if such failure is attributable to the negligence or misconduct of ImmunoGen.

Related to Batch Run

  • Master Batch Record or “MBR” shall mean, with respect to each Presentation of Clinical Product or Commercial Product to be Produced hereunder, a formal set of instructions for the Production of each Presentation of such Product. The MBR shall be developed and maintained in Xxxxxx’x standard format by Baxter, using Celator’s master formula and technical support.

  • 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.

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.

  • API means American Petroleum Institute.

  • cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • technical specification means, with respect to any Software, the document setting forth the technical specifications for such Software and included in the Statement of Work.

  • Acceptance Test Document means a document, which defines procedures for testing the functioning of installed system. The document will be finalized with the contractor within 7 days of issuance of the Letter of Award.

  • 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.

  • Manufacturing Process means any process for—

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

  • Quality Agreement has the meaning set forth in Section 9.6.

  • QA means quality assurance.

  • Drug test means a test designed to detect the illegal use of a controlled substance.

  • Project Plan means the document to be developed by the Contractor and approved by Webel Technology Ltd., based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalized Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by Webel Technology Ltd. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • Double Phase Aerosol Air Freshener means an aerosol air freshener with the liquid contents in two or more distinct phases that requires the product container be shaken before use to mix the phases, producing an emulsion.

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”