Product costs, risk sharing

Risk sharing of production costs and/or electricity output Let s turn to the first barrier to successfully forming a JNOC. 

Beyond these indirect costs, there are future costs associated with new or more stringent variations of existing environmental legislation. We also need to recognize that all operations, especially those within complex industry sectors like petrochemicals, carry liabilities and exposures to potential catastrophic releases. Systems do fail for a variety of reasons, leading to unplarmed and sometimes innocent mistakes, that may result in third-party exposures for environmental damages or health risk exposures. These costs are related to legal fees, loss in consumer confidence, and subsequent losses in market shares for the products a company sells, as well as the clean-up associated with the spill or release. 

The plan will eventually prescribe a likely filing date for a marketing authorisation application (MAA) (product hcence). This date is vital and when the plan becomes public information, any slippage in the date is likely to impact on the share price of the company. Accordingly, senior members of the company must be confident that the date can be met. There will always be pressure to bring the date forward but this has a cost in resources, and risks damaging credibility with investors if the accelerated timelines cannot be met. 

Share the cost and risk of clinical trials—and, of course, lose most of the potential upside—making sure that they license the product of their preclinical research to a company very experienced in the therapeutic area or clinical field. 

The fed-batch and batch cultivation systems share the same cleaning and sterilization process in which the bioreactor operation is stopped and the bioreactor is emptied. This stoppage creates considerable costs and operational downtime. The repeated or cyclic system, which can be applied to both batch and fed-batch cultivation systems, may be installed in order to maximize the productivity. The cyclic cultivation system does not enter the cleaning and sterilization process, but rather empties a portion of the bioreactor while preserving part of the batch for the next cycle. Another method to increase productivity is cell retention techniques such as fluidized beds, membranes, or external separators. These options allow multiple cycles without cleaning and sterilization, which is initiated only if it is deemed that mutation risks exceed tolerable levels (Bellgardt, 2000b). 

---