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 Parties shall use reasonable commercial efforts to commence discussions regarding possible key principles of any Supply Agreement after the first successful Release of a Development Batch.
In the case of a delay resulting from an Avecia default, if Nuvelo decides to have Avecia proceed with Development Batch Manufacture and/or the Validation Campaign, Avecia shall carry out the delayed Development Batch Manufacture or Validation Campaign in accordance with the terms and conditions set forth in Clauses 2.3 and 2.4.
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.
Except with respect to a delay resulting from or arising out of an Avecia Default or Nuvelo’s refusal to take a license under a Patented, Licensed Avecia Invention under Clause 5.2(c), Avecia shall not be obliged to carry out the delayed Development Batch Manufacture or the Validation Campaign (as appropriate) until the Parties have reached agreement on the later commencement thereof, but will use reasonable commercial endeavours to reschedule the availability of its facility and appropriate personnel.
Wyeth and Genentech shall collaboratively analyze all appropriate data pertaining to each Development Run to identify any anomalies or errors in each Development Batch and identify possible causes and solutions in order to apply such solutions to the next subsequent Development Run Start.
Additionally, the term Development Batch shall include any Batch manufactured following (i) a change in Specifications, or (ii) a scale-up in the manufacturing process to produce greater quantities of Product, until Catalent has manufactured the required number of consecutive Batches of Product meeting the new Specifications.
All charges shall commence from the Date of Acceptance of the Service at a Location except that: (a) Tail Circuit charges shall commence from the date of installation of the Tail Circuit at a Location by the TO; (b) any Software license fees shall commence from the date of delivery of the Software to Customer.
An employee may be granted no more than 8 hours of leave in a workday.