Bulk Tablets definition

Bulk Tablets means the Licensed Product in bulk tablet form packaged in drums.
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Bulk Tablets means the product listed on Schedule A;
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Bulk Tablets means the Product containing Compound in tablet form, supplied in bulk (not packaged) quantities, the formulation and specification of such tablets to be as used in the Ongoing Clinical Studies or in such other form(s) as the PDC deems appropriate. For the avoidance of doubt, the Bulk Tablets formulation excludes, and is different from, the Product in the “flash-melt” formulation.
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Examples of Bulk Tablets in a sentence

  • Esperion shall provide all assistance reasonably requested by Otsuka in connection with such preparation and filing of Regulatory Documentation and communications with Regulatory Authorities, and, at the request of Otsuka, Esperion shall send representative(s) of Esperion to attend in-person meetings with Regulatory Authorities in the Otsuka Territory relating to the Manufacture of API(s) or Bulk Tablets, all at Esperion’s cost and expense.

  • Esperion shall use Commercially Reasonable Efforts to include in each agreement between Esperion and its CMOs and other Third Party Manufacturers that Manufacture Bulk Tablets or API(s) for the Otsuka Territory [***].

  • Otsuka shall be responsible, at its sole cost and expense, for the primary and secondary packaging of the Bulk Tablets for clinical and commercial use in the Otsuka Territory.

  • A copy of the responses will be provided to Otsuka for review and comment on such responses in advance of the date such responses are due, to the extent such responses pertain to the Manufacture of Bulk Tablets or API(s) for the Otsuka Territory, and Esperion shall consider Otsuka’s comments in good faith prior to responding.

  • The Parties anticipate that the specifications for Bulk Tablets for the Otsuka Territory as set forth in the Supply Agreement will be the same in all material respects as the then-current FDA-approved specifications for Bulk Tablets.

  • Fourth, the exokernel provides robust crit- ical sections: inexpensive critical sections that are implemented by disabling software interrupts [3].

  • Thereafter, Sepracor shall not appoint any other third party manufacturer nor change the location of any part of the manufacturing process for the manufacture of Bulk Tablets for GSK without GSK’s prior written consent, not to be unreasonably withheld, and subject to the change control procedure set out in the Quality Agreement.

  • Following receipt of the inspection results or audit observations of the Governmental Authority from such inspection or audit (a redacted copy of which Esperion will promptly provide to Otsuka to the extent it relates to the Bulk Tablets or API(s) Manufactured for the Otsuka Territory), Esperion will prepare any appropriate responses.

  • For commercial use, Esperion shall supply the API(s) or Bulk Tablets on an [***] basis at [***].

  • In the event Otsuka sends Esperion written notice requesting technology transfer to enable Otsuka, or the applicable CMOs selected by mutual agreement of the Parties, to Manufacture Bulk Tablets from API(s) supplied by Esperion for the Otsuka Territory, then the Parties shall mutually agree on a technology transfer plan for such technology transfer and shall implement the technology transfer activities in accordance with such mutually agreed technology transfer plan.


More Definitions of Bulk Tablets

Bulk Tablets means finished tablets containing the Active Ingredient which meets the relevant specifications, to be defined more specifically in the Supply Agreement, and to be shipped to GSK by Sepracor in bulk in the manner set forth in the Supply Agreement, and then to be packaged as the Product by or on behalf of GSK.
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Bulk Tablets means Bulk Substance formulated into finished tablets.
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Bulk Tablets means Licensed Product in its formulated, bulk (un-packaged) tablet form (without bottle or blister packaging).
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Related to Bulk Tablets

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

  • 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;

  • 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.

  • 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.

  • Polystyrene foam means blown polystyrene and expanded and

  • Feed ingredient means each of the constituent materials making up a commercial feed.

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

  • Bottle means any vessel intended to contain liquids and having a capacity of not more than 43

  • Hydrofluorocarbons means compounds that only contain hydrogen, fluorine, and carbon.

  • Bulk gasoline terminal means a gasoline storage facility which receives gasoline from its supply source primarily by pipeline, ship, or barge, and delivers gasoline to bulk gasoline plants or to commercial or retail accounts primarily by tank truck; and has an average daily throughput of more than 76,000 liters (20,000 gallons) of gasoline.

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

  • Milk means the produce of the milking of one or more cows;

  • Diesel means a distillate oil which can be used as fuel for the operation of a compression ignition engine and which has an approximate boiling temperature of between 150 °C to 400 °C;

  • Packaged means bottled, canned, cartoned, or securely wrapped.

  • Labeling means all labels and other written, printed, or graphic matter on an article or any of its

  • 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;

  • Aerosol cooking spray means any aerosol product designed either to reduce sticking on cooking and baking surfaces or to be applied on food, or both.

  • Contract Quantity means the quantity of Delivered Energy expected to be delivered by Seller during each Contract Year as set forth in the Cover Sheet.

  • Sewage sludge weight means the weight of sewage sludge, in dry U.S. tons, including admixtures such as liming materials or bulking agents. Monitoring frequencies for sewage sludge parameters are based on the reported sludge weight generated in a calendar year (use the most recent calendar year data when the NPDES permit is up for renewal).

  • Consumables means where the context permits, Digital Print Consumables, Inkjet Printing System Consumables and Prepress Consumables.

  • Bill of Quantities means the priced and completed Bill of Quantities forming part of the tender.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

  • Normal form radioactive material means radioactive material that has not been demonstrated to qualify as special form radioactive material.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.