Manufacturing Run definition

Manufacturing Run means a manufacturing run for the Product on a [***] scale under cGMP, in accordance with the Services Related Requirements of the Specifications and Quality Agreement and using the Manufacturing Process.
Manufacturing Run means a Run conducted in accordance with the Master Manufacturing Record that is initiated following the commencement of manufacture pursuant to Section 5.1 and is used to create Product for research and development or for clinical trial use by the Client. “Master Batch Record” shall mean master product and control records for the Product, which shall include, without limitation, (i) the manufacturing instructions, (ii) formulation, (iii) Product Specifications, (iv) the Manufacturing Process; and (v) analysis methods for the Product and as further defined in the Quality Agreement. “Master Cell Bank” means the reference deposit or collection of vials of the Cell Line, either as received from Client or as prepared by Paragon under cGMP pursuant to this Agreement, from which the Working Cell Bank is derived for a Project. “Master Manufacturing Record” means, for each Project, the template document proposed by Paragon and approved by Client that defines the final and complete manufacturing methods, test methods, materials, and other procedures, directions and controls associated with the manufacture and testing of Product. Batch Documentation shall be prepared based on the Master Manufacturing Record. The Master Manufacturing Record shall also include or incorporate by reference, without limitation, such information as Materials Specifications, in process and final Product sampling standards, equipment and instrumentation specifications and standard operating procedures, including, without limitation, standard operating procedures for in-process quality control testing. “Materials Specification” means a document detailing the chemical, physical, microbiological and biological test methods and/or specifications required for release of each Raw Material, Resin or Consumable, each as predetermined and mutually approved by the Parties and made a part of the Master Manufacturing Record. “Non-Conforming Product” means Product whose manufacture, analysis and/or packaging fails to conform to all of the warranties set forth in Section 11.2.1. “Paragon” shall have the meaning set forth in the introductory paragraph, or any successor or permitted assign. Paragon shall have the right to cause any of its Affiliates to perform any of its obligations hereunder, and Client shall accept such performance as if it were performed by Paragon. “Paragon Confidential Information” means all technical and other information, whether patented or unpatented, relating to the Paragon Facil...
Manufacturing Run means a manufacturing campaign for the Product on under cGMP, in accordance with the Specifications, a Product Addendum, and Quality Agreement and using the Manufacturing Process.

Examples of Manufacturing Run in a sentence

  • In case the reason for the non-compliance cannot be determined, Merck shall pay Manufacturer [***] of the applicable Price for the respective Manufacturing Run.

  • However, I cannot guarantee that others in the group will maintain confidentiality. Digital voice recorders will be used to record the discussion.

  • Sen1(202) overexpression corrects the snR13 termination defect of the swd2-3 strain at the re- strictive temperature.

  • In order to meet a potential increase of Product demand by Merck from [***] Manufacturing Run in [***] to the [***] Manufacturing Runs from [***] onwards as shown in the table under Section 2.6, Manufacturer undertakes to expand at its own cost its manufacturing capacity accordingly in [***].

  • Merck is aware that the consumption and prices of Materials and consumables vary from Manufacturing Run to Manufacturing Run.

  • The dependency of net earnings on shrinking expenditures, rather than higher revenues, does not bode well for sustained growth, and the reduction in payroll means a loss of valuable jobs in the City’s securities industry.

  • EASTSIDE will retain samples of each Manufacturing Run up to 1 year.

  • For the avoidance of doubt, Manufacturer shall not be responsible for (and Merck shall pay the Price for such Manufacturing Run in full) if the reason for the non-compliance of the Product is for any other reason but for a breach of the warranties set out in Section 9.1, such other reason being for example [***].

  • For the avoidance of doubt, Manufacturer shall not be responsible for (and MoonLake shall pay the Price for such Manufacturing Run in full) if the reason for the non-compliance of the Product is for any other reason but for a breach of the warranties set out in Section 9.1, such other reason being for example [***].

  • For the avoidance of doubt, Section 4.8 shall apply, i.e. MoonLake shall only be obliged to pay part of the Price for a Manufacturing Run set out in a Work Order depending on the time of receipt of MoonLake’s termination notice.


More Definitions of Manufacturing Run

Manufacturing Run means a Run conducted in accordance with the Master Manufacturing Record that is initiated following the commencement of manufacture pursuant to Section 5.1 and is used to create Product for research and development or for clinical trial use by the Client.

Related to Manufacturing Run

  • 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.

  • 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 Process means any process for—

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • 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;

  • 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;

  • 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.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Manufacturing Agreement has the meaning set forth in Section 4.3.

  • Distillery manufacturing license means a license issued in accordance with

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

  • 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.

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • API means the American Petroleum Institute.

  • Product Specifications means those Manufacturing, performance, quality - control release, and Fill/Finish specifications for Drug Substance or Licensed Product in the Territory, which are initially as set forth in the applicable Regulatory Approval for a Licensed Product, as such specifications may be amended from time to time pursuant to the terms of this Agreement.

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

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.

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

  • 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.

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

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

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

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”