Manufacturing Stage definition

Manufacturing Stage means one or more sequential unit operations and which are followed by a quality assessment of the material resulting from that stage;
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Manufacturing Stage has the meaning set forth in Section 7.2(a).
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Manufacturing Stage has the meaning ascribed to such term in the Manufacturing Agreement.
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Examples of Manufacturing Stage in a sentence

  • Manufacturing Stage is defined as the completion of: [**] Upon receipt of test results and internal release by Quality Assurance/Quality Control, the material is advanced to the Formulation Stage.

  • In addition, Zai shall reimburse Entasis for all out-of-pocket expenses and costs incurred by Entasis to assist Zai in connection with such Manufacturing Stage transfer.

  • Zai shall reimburse Entasis’s good faith estimate of internal expenses and costs at the FTE Rate for FTEs engaged to assist Zai in connection with a Manufacturing Stage transfer initiated by Zai pursuant to this Section 7.2(a).

  • MSU will be responsible for an initial financial investment (“Contribution in Aid of Construction” or “CIAC”) based on 4- County’s total infrastructure investment minus the following: (a) TVA Transmission Line Agreement Deposit: Part or all of the line extension cost associated with the transmission line improvements will be credited back to 4-County by TVA upon the facility taking delivery of power in the Manufacturing Stage.

  • If a Batch is a Non-Conforming Batch and the cause of that Batch being a Non-Conforming Batch is not a failure by Fujifilm to comply with clause 4.1 [***] then the Customer shall pay the Charges relating to the Non-Conforming Batch in full and the relevant Manufacturing Stage, Disposition and all related and ancillary activities shall be deemed to have been completed under the Scope of Work.

  • The Company and Union agree that, if a new classification of employee is created by the DHS/FPS or Department of Labor and such classification of employee is employed pursuant to a contract between the Company and DHS/FPS, and are otherwise an "employee" under Section 1.2, the Company and Union shall negotiate over the health and welfare benefits to be set for that new classification of employee.

  • The evolution of a developed nation is generally said to be in the following stages: Manufacturing (Stage 1), R&D (Stage 2), and Branding (Stage 3).

  • If (a) KB or KB USA waives its right to submit a bid pursuant to Section I.A.2 or (b) TR waives such right and KB or KB USA, as the case may be, does not elect to perform the relevant Manufacturing Stage, and (c) no other conforming bids are received, subject to the provisions of Section 3.01(d)(iii), KBI shall secure a Producer for such Manufacturing Stage and the Transfer Price for the relevant Manufacturing Stage of that Product will be computed as provided in Section 5.01(c).

  • In such event, KB USA may elect to perform the Packaging Manufacturing Stage, and the Transfer Price therefor will be computed in accordance with Exhibit IVB.

  • At least thirty (30) days prior to the beginning of Calendar Year 2010 (and each Calendar Year thereafter), Gilead shall provide to Tibotec an estimated Manufacturing Fee for each Manufacturing Stage for such Calendar Year, together with reasonable documentation with respect thereto.


More Definitions of Manufacturing Stage

Manufacturing Stage a Stage of a Program during which production, testing and Disposition (if applicable) of Engineering Batches or cGMP Batches are intended to take place, including pre and post manufacturing activities; Facility change–over, setup, and cleaning before, between and after Batch manufacturing;
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Manufacturing Stage means, with respect to a Unit of Territory Combination Product, either of the following Manufacturing activities: (a) tableting or (b) placing tablets into unlabeled bottles, as applicable.
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Manufacturing Stage. Any of the following stages in the manufacture of a Product: (i) manufacture/synthesis of the Bulk Chemical Form of the applicable Compound or Compounds, (ii) Formulation and (iii) the Packaging of the Finished Dosage Form.
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Manufacturing Stage means, with respect to a Unit of Territory Combination Product, either of the following Manufacturing activities:
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Manufacturing Stage or “Manufacturing Stages” shall mean a Stage or Stages of a Program identified in the applicable Scope during which production, testing and Disposition (where applicable) of an Engineering Batch or cGMP Batch is intended to take place, including preproduction activities; Facility change–over, setup, and cleaning before, between and after Batch manufacturing.
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Related to Manufacturing Stage

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

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

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • 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.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

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

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

  • Manufacturing Process means any process for—

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

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

  • Other Product means Product which an End User acquired from sources other than Integrator.

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • 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.

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Nicotine product means a product that contains nicotine and is not any of the following: