yields, difficulties obtaining necessary raw materials on favorable terms or at all, quality control, product testing, operator error, lack of availability of qualified personnel, as well as failure to comply with strictly enforced regulations. We may also experience complications or delays in the construction of our J.POD® facilities, as well as unforeseen manufacturing issues with the J.POD® facilities once operational.
We have limited redundancy among our manufacturing facilities, and if any of our manufacturing facilities experience difficulties, including but not limited to manufacturing, product release, shelf life, testing, storage and supply chain management or shipping, any production may be delayed or suspended until we can resume operations. In order to resolve such difficulties, we may also be required to incur significant expenditures. If we were to encounter any of these difficulties, our ability to satisfy our partners’ requirements could be jeopardized.
Furthermore, if microbial, viral or other contaminations are discovered in our laboratories or manufacturing facilities, such facilities may need to be closed for an extended period of time to investigate and remedy the contamination. We cannot assure you that any of these or other issues relating to our manufacturing operations will not occur in the future. Any delay or interruption in the supply of products for clinical trials could delay the completion of clinical trials and, depending upon the period of delay, require our partners to begin new clinical trials or terminate clinical trials completely, where Evotec may be liable for such additional expenses depending on the relevant services agreement.
Our manufacturing facilities also require certification and validation activities to demonstrate that they operate as designed. In addition, our manufacturing facilities are subject to regulatory inspections by the FDA, the national competent authorities in EU member states (including AIFA in Italy), the Medicines and Healthcare products Regulatory Agency (“MHRA”) in the UK, and other comparable regulatory authorities. If we are unable to reliably manufacture products in accordance with the legal and regulatory requirements of the relevant regulatory authorities, we may not obtain or maintain the necessary approvals. Further, our facilities may fail to pass regulatory inspections, which would cause significant delays and additional costs required to remediate any deficiencies identified by the regulatory authorities. Any of these challenges could delay completion of clinical trials, require bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay regulatory approval, impair commercialization efforts, increase our cost of goods, and have an adverse effect on our business, financial condition, results of operations and growth prospects.
Any failure, unauthorized access, security breaches, loss of data and other disruptions to our information technology systems could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability.
We collect and maintain information in digital form that is necessary to conduct our business, particularly for purposes of our EVOpanOmics, EVOpanHunter, J.DESIGN and our iPSC-based drug discovery platforms, and we are highly dependent on our information technology systems. In the ordinary course of our business, we collect, store, and transmit large amounts of confidential information, including intellectual property, proprietary business information, human samples, personal information, and data to comply with current Good Manufacturing Practice (“GMP”), similar foreign requirements and data integrity requirements. We have also outsourced elements of our information technology infrastructure, and as a result a number of third-party vendors may or could have access to confidential information. Despite the implementation of security measures and safeguards, our information technology systems and data and those of our current or future contractors and consultants are vulnerable to compromise or damage.
Our internal computer systems and those of our current and any future partners, vendors, and other contractors or consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, cybersecurity threats, war, and telecommunication and electrical failures. Furthermore, because the techniques used to obtain unauthorized access to, or to sabotage, systems change frequently and often are not recognized until launched against a target, we may be unable to anticipate these techniques or
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