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 bulk active Licensed Compound, manufactured in accordance with cGMP.

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.

Examples of Bulk Substance in a sentence

Should the other party so request due to insufficiency of its own such supplies and if agreed to by the other party, the parties will supply each other with amounts of Bulk Substance and/or Bulk Product for development purposes.
AHP agrees that, upon AHP and its supplier of Substance entering into the Bulk Substance Supply Agreement, AHP shall waive its rights under the Confidentiality Agreement among AHP, Horizon, EJ Financial and Mikart, the License Agreement and this Agreement to the extent such agreements prohibit Horizon from communicating with such supplier and entering into agreement(s) regarding the Substance with such supplier.
KaloBios is responsible for arranging for shipment of Bulk Substance from the site of manufacture and all quality matters related thereto in accordance with the Supply Agreement.
Reprocessing of Bulk Substance will only be permitted based on the criteria defined in Section 4 of the [***] QTA.
The purpose of such an arrangement would be for Horizon to obtain price, quantity, destination and delivery date terms comparable to AHP's rights under the Bulk Substance Supply Agreement.
Sanofi or its subcontractor shall ensure all retention samples are stored in secure conditions consistent with the specified Bulk Substance storage conditions and the samples shall be retained for the minimum period according to cGMP, or as per request from KaloBios if a longer retention period is required.
The parties will on a regular basis coordinate and exchange -------- information related to producing Bulk Product and Bulk Substance.
Such individuals as designated shall use due diligence and best efforts in conducting such Quality Control activities so as not to delay STEROIDS ability to release Bulk Substance or Product and secure payment therefore on a regularly scheduled basis.
Subsequent to this initial period, Lundbeck undertakes to manufacture or have manufactured and supply Bulk Product and/or Bulk Substance for its own galenic (experimental), non-clinical and clinical use.
As defined in Sections 5 and 6 of the [***] QTA, Sanofi or its subcontractor shall test Bulk Substance and other materials, including raw materials, in-process materials, intermediates, and stability samples in accordance with the current approved Specifications, using analytical methods that have been qualified and/or validated, as appropriate for products for use in human clinical trials.

More Definitions of Bulk Substance

Bulk Substance means the pharmaceutically active substance of a Product in bulk form.

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.

Bulk Substance means the bulk active drug substance for the manufacture of the Licensed Products.

Bulk Substance means the bulk active ingredient with the generic name pergolide mesylate.