definiens: or means the document agreed on by the Parties in a signed writing that defines the Manufacturing Process of a particular Product, and pertains to the manufacture and supply of each Batch of Product, as may be amended from time to time by a signed writing of the Partie s. The Master Batch Record shall include, without limitation, the appropriate applicable requirements for components ( such as Raw Materials, [COMPANY] -supplied Materials, intermediates, in -process materials, and packaging materials and labels ) and quantitie s of each as used ; major production equipment ; detailed production instructions, including sequences to be followed ; sampling instructions and in -process controls with their acceptance criteria ; time limits for completion of individual processing steps and /or the total process ; expected yield ranges at appropriate phases of processing or of time ; special notations and precautions to be followed ; and instructions for storage of the intermediate, in -process material, Product to assure its viability for use . T he Master Batch Record shall be presented in the English language . The Master Batch Record shall also incorporate by reference, without limitation, such additional information as may be required under the Quality Agreement