Bulk Intermediate definition

Bulk Intermediate means the bulk purified monoclonal antibody protein produced using the Cell Line and subsequently purified.
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Bulk Intermediate means the bulk form of [***] whether for use in the Manufacture of Bulk Drug or for delivery to a Third Party. When the context requires, Bulk Intermediate for delivery to Third Parties is referred to herein as “Third Party Intermediate.”
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Bulk Intermediate means * * *.
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Examples of Bulk Intermediate in a sentence

  • Prior to the Manufacture of the first Validation Batches of each of Bulk Intermediate and Bulk Drug under the Initial PO, RELYPSA and LANXESS shall each review and mutually approve the Master Batch Record for the Bulk Intermediate or Bulk Drug, as applicable.

  • Following the completion of the Facility Investments and prior to the commencement of Manufacturing for Product Launch, LANXESS will Manufacture and Release a quantity of Bulk Intermediate and Bulk Drug as specified by RELYPSA to validate Manufacturing at the Facility (the “Validation Batches”).

  • If DSM determines that proper Manufacturing of Bulk Intermediate and/or Bulk Drug requires the retention of one or more subcontractors or consultants, including Affiliates, DSM will obtain the written approval of RELYPSA, which approval will not be unreasonably withheld, delayed or conditioned, and of any applicable Regulatory Authority (if required) before using any Affiliates, subcontractors or consultants.

  • Unless the Parties otherwise agree from time to time with respect to specific Batches, no Bulk Intermediate will be used in the Manufacture of Bulk Drug, and no Bulk Drug will be delivered, unless such Bulk Intermediate or Bulk Drug, as applicable, has first been Released by LANXESS (or any Third Party testing facility qualified by RELYPSA) and, except as otherwise expressly provided herein, RELYPSA shall have no obligation to pay the Base Price for any Batch of Bulk Drug until such Batch is Released.

  • Delivery of Bulk Intermediate or other samples by Laureate shall be deemed to have taken place upon delivery to carrier at the Facility.

  • Pursuant to certain binding terms of the MOU, LANXESS agreed to produce MFA and Manufacture and supply Bulk Intermediate and Bulk Drug for the Initial Term.

  • DSM shall provide the agreed analytical support for Raw Materials, Bulk Intermediate, and/or Bulk Drug, cleaning, potency, controls for impurities in MFA and other Raw Materials, Bulk Intermediate and/or Bulk Drug, cGMP testing and documentation, and the like, according to the Quality Agreement and the Specifications and as required by in this Agreement or each Firm Order.

  • In the event of early termination of this Agreement, any advance payments made under Section 8.5 will be refundable to the extent LANXESS does not deliver such materials (or in the case of Bulk Intermediate, such Bulk Intermediate or any Bulk Drug resulting from use of such Bulk Intermediate) to RELYPSA or its designee in accordance with Section 23.

  • Manufacturing Assumptions: API – API (NCD Meloxicam Bulk Intermediate) will be stored under refrigerated conditions (2-8°C).

  • DSM shall assist RELYPSA in the preparation of documentation in relation to the Manufacture of Bulk Intermediate and/or Bulk Drug as may be reasonably required by RELYPSA in support of RELYPSA's submissions to Regulatory Authorities in respect of the Product and the Manufacture of Bulk Intermediate and Bulk Drug by DSM.


More Definitions of Bulk Intermediate

Bulk Intermediate means, as regards a Plasma Protein, the bulk fraction obtained directly from the application of the related Primary Capture Step of the PPPS Backbone, as applicable, to the Raw Material and containing a high concentration of such plasma protein, before being subjected to a Downstream Process to produce Bulk Active of such product;
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Bulk Intermediate means the bulk form of [***] which has been Manufactured or is to be Manufactured by LANXESS pursuant to this Agreement.
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Related to Bulk Intermediate

  • Bulk means material that is stored or transported in a loose, unpackaged liquid, powder, or granular form capable of being conveyed by a pipe, bucket, chute, or belt system.

  • Bulk plant means a motor fuel storage and distribution facility that is not a terminal and from

  • 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.

  • Parenteral means a method of drug delivery injected into body tissues but not via the gastrointestinal tract.

  • LNG means liquefied natural gas.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Bulk Supply means a supply agreement made under section 40 of the Act;

  • Bulk carrier means a ship which is intended primarily to carry dry cargo in bulk, including such types as ore carriers as defined in SOLAS chapter XII, regulation 1, but excluding combination carriers.

  • Chemical Storage Facility means a building, portion of a building, or exterior area adjacent to a building used for the storage of any chemical or chemically reactive products.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • In-stream Waste Concentration or "(IWC)" means the concentration of a discharge in the receiving water after mixing has occurred in the allocated zone of influence.

  • Cannabis testing facility means an entity registered by

  • Remanufactured means factory rebuilt to original specifications. "Virgin material" means—

  • spare part means a separate part of an EEE that can replace a part of an EEE. The EEE cannot function as intended without that part of the EEE. The functionality of EEE is restored or is upgraded when the part is replaced by a spare part;

  • Bulk mixing plant means machinery, appliances or other similar devices that are assembled in such a manner so as to be able to mix materials in bulk for the purposes of using the mixed product for construction work;

  • 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.

  • Exfiltration means any unauthorized release of data from within an information system. This includes copying the data through covert network channels or the copying of data to unauthorized media.

  • iron ore pellets means iron ore in pellet or other form produced by Pelletisation or more advanced reduction or other more advance treatment process from iron bearing material mined from the mining areas.

  • Process Wastewater means any water which, during manufacturing or processing, comes into direct contact with or results from the production or use of any raw material, intermediate product, finished product, by-product, or waste product.

  • Bulk gasoline plant means a gasoline storage and distribution facility with an average daily throughput of 20,000 gallons (76,000 liters) of gasoline or less on a 30-day rolling average.

  • Transport means the most efficient and available method of conveyance. In all cases, where practical, economy fare will be utilized. If possible, the Insured’s Common Carrier tickets will be used.

  • Filtration means a process for removing particulate matter from water by passage through porous media.

  • Biodiesel means a fuel composed of mono-alkyl esters of long chain fatty acids derived from vegetable oils or animal fats, and, in accordance with standards specified by the American society for testing and materials, designated B100, and meeting the requirements of D-6751, as approved by the department of agriculture.

  • iron ore concentrates means products (whether in pellet or other form) resulting from secondary processing but does not include metallised agglomerates;

  • Clean coal SNG facility means a facility that uses a

  • bulk cargo means any quantity of alumina or the usual bulk materials used in an alumina industry and being bauxite or alumina for shipment or materials consigned for use by the Company or by any subsidiary Company or by any associated Company in connection with its operations in that industry;