Definition of Pre-Commercial Lots

Pre-Commercial Lots means the API as manufactured for the purpose of conducting human clinical studies as well as for pre-commercial work such as experimental, demonstration and stability lots.
Sample 1

Examples of Pre-Commercial Lots in a sentence

DPC shall be responsible for the testing and release of the Pre-Commercial Lots.
As set forth in Schedule B, DPC shall be responsible for performance of the manufacturing process of the Pre-Commercial Lots.
DPC shall perform: (i) development and validation of all API analytical methods set forth on Schedule A hereto, (ii) Materials USP/NF monograph testing, and (iii) all analytical and microbiological testing for API and for release of Pre-Commercial Lots.
DPC and NovaCardia shall agree on the schedule for manufacture and delivery of API and Pre-Commercial Lots.
DPC shall provide the Materials for the manufacture of the Pre-Commercial Lots.