Common use of Fermentation Clause in Contracts

Fermentation. After the completion of the first L-DOS47 engineering batch and review of the production process, the second 500-1000 L 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 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 and 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 production processL-DOS47 Engineering batches, the second 500-1000 L engineering Clinical 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 batch 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 records, QC test methods and notebooks procedures. Deliverables Completed batch records, QC reports and Development report

Fermentation. After the Upon completion of the first L-DOS47 engineering batch 30L trial, and review of concurrent with the production processwork to prepare the purified Urease, the second first 500-1000 L engineering 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. 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 first engineering 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 500 L (350-650 350 L working) Time 7 days Documentation Draft Batch records records, draft QC methods and notebooks Deliverables Completed batch records, QC reports and Development report