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.

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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...

Examples of Manufacturing Run in a sentence

Supplier must receive authorization from Ceribell prior to commencing any Manufacturing Run.
A "Manufacturing Run" is a discrete period in which manufacturing of Ceribell Product is performed with the intention of providing a set quantity of Product as specified in a Purchase Order or BPO.
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.
In case the reason for the non-compliance cannot be determined, Merck shall pay Manufacturer [***] of the applicable Price for the respective Manufacturing Run.
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 [***].
Following the completion by ZGEN or its subcontractors of the validation of assays for release of Factor XIII drug substance pursuant to Section 5.3, ZGEN or its subcontractors will test each GMP Manufacturing Run using these validated assays and will provide a certificate of analysis to NN for each GMP Manufacturing Run based upon these validated assays.
For the avoidance of doubt, Section 4.8 shall apply, i.e. Merck 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 Merck’s termination notice.
Manufacturer shall provide Merck with authorized electronic copies of the [***] records, the [***], the [***], and when applicable, the [***] at each time point and the invoice for each Manufacturing Run in accordance with the Delivery Terms on the Delivery Date specified in the relevant Work Order or Purchase Order confirmed by Manufacturer pursuant to ARTICLE 4 above.
For the avoidance of doubt, the aggregate of all amounts that may be creditable pursuant to this Section 5.5(d) against future milestone fees due pursuant to Section 4.2 shall not exceed [ * ]; provided, however, that in the event NN uses any GMP Manufacturing Run material, NN shall not be entitled to a credit pursuant to this Section 5.5(d) and if NN has taken a credit for such material, NN shall pay to ZGEN the amount of such credit.

More Definitions of Manufacturing Run

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.