Batch

Batch. Means a single run of Product produced by a single execution of the procedures specified in the Master Production and Control Record.

Batch. Shall mean a specific quantity of Product that is intended to have uniform character and quality, within the limits specified in the Product Specifications, and is produced during one cycle of manufacture.

Batch. Means the quantity of total bulk purified Product (including samples taken during the 5000 Liter Process) which is produced as a result of the completion of one operation of the 5000 Liter Process for the [*****] REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. 4 Product in the 5000 Liter Manufacturing Suite in... accordance with the Specifications and with cGMP. View More

Batch. Means a specific quantity of Product Manufactured by Corden under cGMP in accordance with the Manufacturer's Release Specifications and Service related requirement(s) stated herein or in any applicable Product Addendum, the Parties' Quality Agreement, and using the Manufacturing Process.

Batch. Shall mean that quantity of units of Product produced from a single homogeneous mix in a single cycle of manufacture.

Batch. Means a specific quantity of API, Manufactured according to the terms of this Agreement, that is intended to be of uniform character and quality and is produced during the same cycle of Manufacture as defined by the applicable batch production record. Confidential Information ****** — Material has been omitted and filed separately with the Commission.

Batch. All material intended to have uniform character and quality that is produced in accordance with established parameters and according to a single manufacturing order during that same cycle of manufacture;

Batch. Means that number of individual Products that requires the Company to devote a full day to production thereto, which the parties hereto estimate shall equal approximately 20,000 individual units of the Products.

Batch. A defined quantity of Product which has been produced during a defined cycle of manufacture, and which is identified by a unique production number

Batch. The entire amount of Product yielded from a manufacturing event using a specific quantity of API, Excipients, and components Processed in accordance with the Master Batch Record