Bulk Substance definition

Bulk Substance means any Licensed Product manufactured in accordance with the specifications agreed to by the Parties and cGMP, which has undergone all processing steps except the steps of formulation, filling and packaging.
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Bulk Substance means the pharmaceutically active substance of a Product in bulk form.
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Bulk Substance means the bulk active Licensed Compound, manufactured in accordance with cGMP.
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Examples of Bulk Substance in a sentence

  • At the time the Product Development Committee is reviewing a Finished Dosage Form Product or Bulk Substance, Schein and Cheminor will inform the other as to any Know-How or Technical Information which is subject to any agreement with a third party, including the details of any such restrictions on use or transfer contained in such agreement.

  • If required, KaloBios shall support Sanofi in assessing the impact of any reprocessing on such batches of Bulk Substance or its intermediates by providing technical and quality expertise.

  • Centaur will unless otherwise agreed supply the Bulk Product and/or Bulk Substance for galenic (experimental), non-clinical and clinical for its own use and will supply the Bulk Product for commercial use (including without limitation use for promotional purposes) meeting quality standards as set forth below.

  • Some criticism of the Tunisian left was based on its acceptance of the political change that occurred with Ben Ali’s accession to power and its “scrambling” for power by welcoming the promises of the 7 November statement.

  • Sanofi or its subcontractor shall notify KaloBios of any quality related deviations for the Bulk Substance, as per Section 6 of the [***] QTA, including deviations that may impact Bulk Substance batches previously delivered to KaloBios.

  • This shall include routine compliance audits and “for cause” audits to address Bulk Substance quality issues.

  • If an IFM Start-Up is terminated in the Real-Time within the applicable IFM Commitment Period through an Exceptional Dispatch Shut-Down Instruction issued while the Bid Cost Recovery Eligible Resource was starting up, the IFM Start-Up Cost for that IFM Commitment Period shall be prorated by the ratio of the Start-Up Time before termination over the total IFM Start-Up Time.

  • Cheminor and Schein shall monitor the relevant patents for each Finished Dosage Form Product and Cheminor Bulk Substance in each jurisdiction that is the subject of this Agreement and shall promptly notify each other of any events, developments or any other information or knowledge that comes into its possession or to which it has access which may have any potential for claim of infringement of any such patent by virtue of the transactions contemplated hereby.

  • Centaur undertakes to manufacture and -------------------------------- supply Bulk Product and/or Bulk Substance for Lundbeck's initial galenic (experimental), non-clinical use, which shall include supplies in the amounts and at the times stipulated and contemplated in the Plan and Annex B until Lundbeck is itself ready to supply its own needs which is expected mid-1997.

  • Sanofi shall ensure a stability testing program, in compliance with cGMP and ICH requirements, is maintained for intermediate and Bulk Substance as per Section 5 of the [***] QTA, including without limitation design of stability program, review and approval of stability protocols and reports, sampling protocols and execution of stability protocols.


More Definitions of Bulk Substance

Bulk Substance means the pure active substance of CPI-1189 delivered in suitable containers as agreed by the parties in accordance with Annex C or such other material as might be agreed to by the parties.
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Bulk Substance has the meaning ascribed to it in the License Agreement, and for greater certainty as regard this Supply Agreement means KB001-A, Manufactured in accordance with Specifications agreed to by the Parties which has undergone all processing steps except the steps of formulation, filling and packaging.
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Bulk Substance means the bulk active ingredient with the generic name pergolide mesylate.
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Bulk Substance means the bulk active drug substance for the manufacture of the Licensed Products.
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Related to Bulk Substance

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

  • Dangerous Substance means any radioactive emissions and any natural or artificial substance (whether in solid or liquid form or in the form of a gas or vapour and whether alone or in combination with any other substance) which, taking into account the concentrations and quantities present and the manner in which it is being used or handled, it is reasonably foreseeable will cause harm to man or any other living organism or damage to the Environment including any controlled, special, hazardous, toxic, radioactive or dangerous waste.

  • Chemical substance means a substance intended to be used as a precursor in the manufacture of a controlled substance or any other chemical intended to be used in the manufacture of a controlled substance. Intent under this subsection may be demonstrated by the substance's use, quantity, manner of storage, or proximity to other precursors or to manufacturing equipment.

  • Dangerous Substances means a substance or article described in regulation 3 of the Dangerous Substances Regulations;

  • 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.

  • Harmful substance means any substance which, if introduced into the sea, is liable to create hazards to human health, to harm living resources and marine life, to damage amenities or to interfere with other legitimate uses of the sea, and includes any substance subject to control by the present Convention.

  • Hazardous Material means any substance, material or waste that is classified, regulated or otherwise characterized under any Environmental Law as hazardous, toxic, a contaminant or a pollutant or by other words of similar meaning or regulatory effect, including petroleum or any fraction thereof, asbestos, polychlorinated biphenyls and radioactive substances.

  • Hazardous Materials does not include products or materials that are commonly used in construction or industrial practice so long as they are used in accordance with the manufacturer’s instructions or Material Safety Data Sheets issued for the product or materials. (See Article 1.6.3 below.)

  • Hazardous Substance means any substance that is: (i) listed, classified or regulated pursuant to any Environmental Law; (ii) any petroleum product or by-product, asbestos-containing material, lead-containing paint or plumbing, polychlorinated biphenyls, radioactive materials or radon; or (iii) any other substance which is the subject of regulatory action by any Governmental Entity pursuant to any Environmental Law.

  • Hazardous Substances means any hazardous or toxic material, substance or waste, pollutant, contaminant or solid waste as defined under applicable Environmental Laws, including petroleum, petroleum products, asbestos, polychlorinated biphenyls and radioactive materials.

  • Contaminant means any material, substance or waste that is classified, regulated or otherwise characterized under any Environmental Law as hazardous, toxic, a contaminant or a pollutant or by other words of similar meaning or regulatory effect, including any petroleum or petroleum-derived substance or waste, asbestos and polychlorinated biphenyls.

  • Hazardous Materials means all explosive or radioactive substances or wastes and all hazardous or toxic substances, wastes or other pollutants, including petroleum or petroleum distillates, asbestos or asbestos containing materials, polychlorinated biphenyls, radon gas, infectious or medical wastes and all other substances or wastes of any nature regulated pursuant to any Environmental Law.

  • Radioactive substance means a substance that emits ionizing

  • Regulated substance means any substance, material or waste the use, generation, handling, storage, treatment or disposal of which is regulated by any local or state government authority, including any of the same designated by any authority as hazardous, genetic, cloning, fetal, or embryonic.

  • Hazardous Materials Contamination means contamination (whether now existing or hereafter occurring) of the improvements, buildings, facilities, personalty, soil, groundwater, air or other elements on or of the relevant property by Hazardous Materials, or any derivatives thereof, or on or of any other property as a result of Hazardous Materials, or any derivatives thereof, generated on, emanating from or disposed of in connection with the relevant property.

  • Contaminants or "pollutants," or words of similar import, under any Environmental Law and (c) any other substance exposure to which is regulated under any Environmental Law.

  • Requirements of Environmental Law means all requirements imposed by any law (including for example and without limitation The Resource Conservation and Recovery Act and The Comprehensive Environmental Response, Compensation, and Liability Act), rule, regulation, or order of any federal, state or local executive, legislative, judicial, regulatory or administrative agency, board or authority in effect at the applicable time which relate to (i) noise; (ii) pollution, protection or clean-up of the air, surface water, ground water or land; (iii) solid, gaseous or liquid waste generation, treatment, storage, disposal or transportation; (iv) exposure to Hazardous Substances; (v) the safety or health of employees or (vi) regulation of the manufacture, processing, distribution in commerce, use, discharge or storage of Hazardous Substances.

  • fissionable substance means any prescribed substance that is, or from which can be obtained, a substance capable of releasing atomic energy by nuclear fission.

  • Substances means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

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

  • Regulated Substances means pollutants, contaminants, hazardous or toxic substances, compounds or related materials or chemicals, hazardous materials, hazardous waste, flammable explosives, radon, radioactive materials, asbestos, urea formaldehyde foam insulation, polychlorinated biphenyls, petroleum and petroleum products (including, but not limited to, waste petroleum and petroleum products) as regulated under applicable Environmental Laws.

  • Hazardous Material Law(s) means all laws, codes, ordinances, rules, regulations and other governmental restrictions and requirements issued by any federal, state, local or other governmental or quasi-governmental authority or body (or any agency, instrumentality or political subdivision thereof) pertaining to any substance or material which is regulated for reasons of health, safety or the environment and which is present or alleged to be present on or about or used in any facilities owned, leased or operated by any Credit Party, or any portion thereof including, without limitation, those relating to soil, surface, subsurface ground water conditions and the condition of the indoor and outdoor ambient air; any so-called “superfund” or “superlien” law; and any other United States federal, state or local statute, law, ordinance, code, rule, regulation, order or decree regulating, relating to, or imposing liability or standards of conduct concerning, any Hazardous Material, as now or at any time during the term of the Agreement in effect.

  • toxic a “pollutant”, a “contaminant”, or words of similar meaning and regulatory effect pursuant to any Environmental Law and also including any petroleum product or by-product, asbestos-containing material, lead-containing paint, mold, polychlorinated biphenyls or radioactive materials.