Common use of Fermentation Clause in Contracts

Fermentation. After the completion and review of the L-DOS47 Engineering batches, the 500-1000 L Clinical batch will commence. The 50 gram conjugate deliverable will require 25 grams of purified AFAIK2. Pending yields this may require 2 × 500 L batches to be performed or a single batch performed at the required volume in a 1000 L fermentor. The fermentation will be performed using batch records revised from the engineering batches to ensure the accepted protocol is followed; additional testing of samples or data collection can be recorded in laboratory notebooks. Site cGMP API Facility Fermentor (s) 30 L (22L working) 500-1000 L (350-650 L working) Time 7 days Documentation Batch records, QC test methods and procedures. Deliverables Completed batch records, QC reports and Development report

Fermentation. After the Upon completion and review of the L-DOS47 Engineering batches30L trial, and concurrent with the work to prepare the purified Urease, the first 500-1000 L Clinical Engineering batch will commence. The 50 gram conjugate deliverable will require 25 grams of purified AFAIK2. Pending yields this may require 2 × 500 L batches to be performed or a single batch performed at the required volume in a 1000 L fermentor. A new continuous centrifuge and microfluidizer will be qualified for the process at this stage. The fermentation will be performed using preliminary batch records revised from the engineering batches to ensure the accepted protocol is followed; additional testing of samples or data collection can be recorded in laboratory notebooks. Site cGMP API Facility Fermentor (s) 30 L (22L working) 500-1000 500 L (350-650 350 L working) Time 7 days Documentation Draft Batch records, draft QC test methods and procedures. notebooks Deliverables Completed batch records, QC reports and Development report

Fermentation. After the completion of the first L-DOS47 engineering batch and review of the L-DOS47 Engineering batchesproduction process, the second 500-1000 L Clinical engineering batch will commence. The 50 gram conjugate deliverable will require 25 grams of purified AFAIK2. Pending yields from the first Engineering batch this may require 2 × 500 L batches to be performed or a single batch performed at the required volume in a 1000 L fermentor. The fermentation will be performed using batch records revised from the first engineering batches batch to ensure the accepted protocol is followed; additional testing of samples or data collection can be recorded in laboratory notebooks. Site cGMP API Facility Fermentor (s) 30 L (22L working) 500-1000 L (350-650 L working) Time 7 days Documentation Batch records, QC test methods records and procedures. notebooks Deliverables Completed batch records, QC reports and Development report