Special Samples and Requests Clause Samples
Special Samples and Requests. [*] Certain portions denoted with an asterisk have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. GDSVF&H\1814591 Page 42 of 46 CONFIDENTIAL The ABDG system is an acronym for Alpha (correct execution), Beta (incorrect execution), Gamma (meets specifications), Delta (Failed specifications). It is a data classification tool that identifies correct process control and experimental data sets. The purpose of applying the tool is to enable calculation of operational performance (control) and process robustness (capability). The system provides clarity across a number of projects, programs, and facilities. Fermentation processes are performed by following a set of instructions. These instructions are in the form of written description in the scope of work. The instructions must include the key process variables and their target set points, acceptable ranges, and concern limits. The key parameters are monitored throughout the process and any deviations are noted. This assessment may be manual or be automated. In Amyris’s fermentation lab and pilot plant we are operating mainly an auto tagging system that is based on the MFCS process control system measurements and the process parameter targets. There are also a small number of manual assessments that are inputted by the operations team. These operational events or discrepancies in execution, or deviations from target, are referred to as tags. In addition to the operational execution tagging there is a further level of assessment of the batch outcomes. This evaluates the ability of the method executed to deliver data and product quality that is within agreed range according to the specifications. The overall system is illustrated in Figure 1. [*] Certain portions denoted with an asterisk have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. GDSVF&H\1814591 Page 43 of 46 CONFIDENTIAL In summary an alpha lot is a batch that has the following basic elements:- • Equipment was set up correctly • The correct raw materials were used • The process operations were conducted correctly • No mechanical issues Beta lots would be batches that exhibit the following elements:- • Contamination • Excursions from set points • Noisy measurements leading to poor control • Equipment or electronic failures • Utility fai...
