Bulk Manufacturing definition

Bulk Manufacturing means the process of producing Bulk Drug Substance.
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Examples of Bulk Manufacturing in a sentence

  • Ophidian shall have principal responsibility for the Bulk Manufacturing Program, and Lilly shall have principal responsibility for the Product Manufacturing Program.

  • As more fully described below, Ophidian will have principal responsibility for the Bulk Drug Substance Process Development Program, the Bulk Manufacturing Program and the manufacture (either itself or through a third party acceptable to Lilly) of Bulk Drug Substance for clinical and commercial supply.

  • Any price movement, either a reduction or increase, in the price of R134a, after that period will be reflected in the Bulk Manufacturing Price and Royalty Fee.

  • The term of this Agreement shall be from the Effective Date until the earlier of the completion of a Formulated Bulk Manufacturing Technology Transfer or termination of the LA.

  • Vertex (assuming it exercises the Vertex Commercial Supply Option referenced in Section 10.1; otherwise Lilly) shall have principal responsibility for the Bulk Manufacturing Program, and Lilly shall have principal responsibility for the Product Manufacturing Program.

  • Except for the qualification, validation and calibration in connection with the Tech Transfer Activities which are part of the Bulk Manufacturing Services, the CDE PM Program shall be considered Non-Bulk Manufacturing Services and the fees for the CDE PM Program shall be set forth in Exhibit F.

Related to Bulk Manufacturing

  • Manufacturing means all activities directed to sourcing of necessary raw materials, producing, processing, packaging, labeling, quality assurance testing, release of a Licensed Product or Licensed Product candidate, whether for Development or Commercialization. When used as a verb, “Manufacture” means to engage in Manufacturing.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

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

  • 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.

  • Distillery manufacturing license means a license issued in accordance with