Development Batch definition
Examples of Development Batch in a sentence
Client shall be responsible for the cost of each Development Batch, even if such batch fails to meet the specifications therefor, unless Catalent was grossly negligent in the manufacture of the out-of-specification batch.
This work is an extension of the Development Batch - Inquiry No. 807836c Currently, [ * ] of [ * ] intermediate [ * ] ([ * ]) was prepared and [ * ] shipped to GTx for development work.
The Additional Centrifuge Work shall be set forth in a Programme Amendment Order, such Programme Amendment Order to include revised timings for Development Batch Manufacture and Validation Campaign, as appropriate.
Client shall be responsible for the cost of each Development Batch that fails to meet the Specifications unless Cardinal Health was negligent in the manufacture of the out of Specification batch..
Paragon shall provide analytical testing of the Process Development Batch as agreed by the Parties in each SOW/Project Plan and will report the results to Client.
Client shall be responsible for the cost of each Development Batch, even if such batch fails to meet the specifications, unless Catalent was grossly negligent in the manufacture of the out-of-specification batch.
Further, Patheon shall not be responsible for any loss or damage to any API where such loss or damage occurs during a batch implementing a new process or procedure (a “Development Batch”); provided, however, that both Parties shall agree, prior to commencement of manufacture of a batch, whether such batch shall be deemed a Development Batch.
A Batch manufactured during Development Batch Manufacture, specifically including the Engineering Batch.
Nuvelo shall have an option to, and otherwise may as a result of an Avecia Default, delay commencement of, or cancel Development Batch Manufacture or the Validation Campaign.
For each Development Batch [*]manufactured by not later than [*]and in compliance with this Agreement, and conformance to cGMP, the Bulk Drug Specifications, and the warranties in Section 7.1, Genentech shall pay Lonza an amount equal to [*] per Batch and, subject to Section 4.5, the Acquisition Cost of raw materials used to manufacture such Batch.