Manufacturing Standards definition

Manufacturing Standards means the specifications for manufacturing, packaging, labeling and storing the Products set forth in the Product Specifications, the master batch record, cGMPs, MSDSs, and all other applicable U.S. laws and regulations.

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Manufacturing Standards means, with respect to the API or any Finished Product, cGMP and such additional manufacturing specifications or standards as may be established by mutual agreement of the Company and ERS from time to time.

Manufacturing Standards has the meaning set forth in Section 5.2.

Examples of Manufacturing Standards in a sentence

Upon request from Buyer, Seller shall provide Buyer with such documents reasonably necessary for Buyer to document and duplicate the Manufacturing Standards for the Products.
Seller shall exclusively own all IP Rights in all know-how, technology, processes, procedures, ideas and concepts developed by Seller or its employees, agents, affiliates or contractors in the course of manufacturing the Products, any modifications, enhancements, improvements to the manufacturing processes for the Products, and any other idea, design, concept, technique, invention or discovery related to the manufacture of the Products during the Term of this Agreement ("Manufacturing Standards").
ERS has no obligation to pay for any shipment of API that (i) ERS and the Company agree does not to meet the Specifications and/or Manufacturing Standards, or (ii) in accordance with Section 8.8(b), ERS has found not to meet the Specifications and/or Manufacturing Standards while such findings have not been contradicted by independent laboratory testing.
Except as provided in Section 1.6(c) below, if Unity fails to notify Ascentage within such [***] ([***]) [***] period of any non-conformity, the Product shall be deemed to conform to the applicable Specifications and Manufacturing Standards.
The Parties shall, at [***] before commencement of deliveries of the Product to Unity, conclude a separate quality agreement in a format suitable for submission to the Regulatory Authorities in all countries of the Territory, recording the agreed-upon Specifications and Manufacturing Standards and measures to assure compliance with cGMP regarding manufacturing, storage, transportation and release of Product (“Quality Agreement”).

More Definitions of Manufacturing Standards

Manufacturing Standards means the specifications for manufacturing process steps and manufacturing conditions set forth in Attachment 2.

Manufacturing Standards means, with respect to a Product, cGMP and such additional manufacturing specifications or standards as may be established by the JMC from time to time.

Manufacturing Standards means information that describes the processes, procedures and requirements specifically related to the manufacture of any Product. Without limiting the foregoing, a "Manufacturing Standard" may include assembly machine programs; reflow profiles; assembly aids; process flows; standard assembly instructions; process control plan; overall process definition; work instructions; process and machine capabilities; design review report; first article inspection reports; and Quality Improvement Plan.

Manufacturing Standards shall have the meaning set forth in Section 7(b)(ii).

Manufacturing Standards means GMP and/or QSR, as applicable to a particular Supplied Item.

Manufacturing Standards means the following standards: IPC-A 610, Class 2.

Manufacturing Standards means, with respect to the Manufacture of a Product that the Product: (i) has been Manufactured in accordance with the Master Batch Documentation and in accordance with the applicable Quality Agreement; (ii) at the time of delivery conforms to the agreed upon Product Specifications; and (iii) has been prepared for shipment in accordance with the procedures and requirements mutually agreed upon by the Parties; (iv) has been Manufactured in accordance with Applicable Laws including, cGMP (if applicable).