54 Numerous U.S. and foreign issued patents and pending patent applications owned by third parties exist relating to ABC technology and in the fields in which we are developing our product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our ABC Platform, product candidates and other technologies may give rise to claims of infringement of the patent rights of others. We cannot assure you that our ABC Platform, product candidates and other technologies that we have developed, are developing or may develop in the future will not infringe existing or future patents owned by third parties. We may not be aware of patents that have already been issued or that a third party, including a competitor in the fields in which we are developing our ABC Platform, product candidates and other technologies, might assert are infringed by our current or future ABC Platform, product candidates or other technologies. Such a dispute may concern claims to compositions, formulations, methods of manufact f ur t e or methods of use or treatment that cover our ABC Platform, product candidates or other technologies. It is also possible that patents owned by third parties of which we are aware, but which we do not believe are relevant to our ABC Platform, product candidates or other technologies, could be found to be infringed by our ABC Platform, product candidates or other technologies. In addition, because patent applications can take many years to issue, there may be currently pending patent applications that later result in issued patents that our ABC Platform, product candidates or other technologies may infringe. Third parties may have patents or obtain patents in the future and claim that the manufact f ur t e, use or sale of our ABC Platform, product candidates or other technologies infringes these patents. If a third party alleges that we infringe their patents or that we are otherwise employing their proprietary technology without authorization and initiates litigation against us, a court of competent jurisdiction could hold that such patents are valid, enforceable and infringed by our ABC Platform, product candidates or other technologies, even if we believe such claims are without merit. In that event, the successful plaintifff may be able to impede our ability to commercialize the applicable product candidate or technology unless we obtain a license under the applicable patents, or such patents expire or are finally determined to be invalid or unenfor f ceable. Such a license may not be availabl a e on commercially reasonabl a e terms or at all. Even if we are able to obtain a license, the license would likely obligate us to pay license fees, royalties or both. Any license granted to us might be nonexclusive, which could result in our competitors gaining access to the same intellectua t l property. If we are unabl a e to obtain a necessary license to a third-party patent on commercially reasonabl a e terms, we may be unabl a e to commercialize our ABC Platform, product candidates or other technologies, or our commercialization effo f rts may be significantly delayed, which could in turn significantly harm our business. We are aware of a number of patents and patent applications that are directed to one or more aspects of tarcocimab a and KSI-501. Our intent is to maintain our development effo f rts under 35 U.S.C. Section 271(e)(1) (which provides a safe harbor from patent infringement claims related to certain drug r development activities) through to at least the launch of any tarcocimab a and KSI-501 product. We are aware of at least one pending patent application with claims that are directed to some aspect of tarcocimab a and KSI-501, and that could, if issued, result in a patent term beyond a potential launch date for tarcocimab a or KSI-501. If this were to occur, we may be required to challenge the validity of the claims, obtain a license, modify tarcocimab a or KSI-501, or delay launch. We are also aware of at least one issued patent family with claims that may be related to some potential future aspect(s) of KSI-501 and that has a patent term beyond a potential launch date for KSI-501. If this or any other patent family were perceived relevant, we may be required to challenge the validity of the claims, obtain a license, modify KSI-501, or delay launch. If we choose to further the pipeline and develop a different product, such a product would be delayed until the expiration of any valid patent that is still in force on such product. Alternatively, our options for addressing any such patents relating to these non- tarcocimab a and KSI-501 products would include the following: challenge the validity of the claims, obtain a license, or modify the non- tarcocimab a and non-KSI-501 products. Defending against infringement claims, regardless of their merit, would involve subs u tantial litigation expense, would be a subs u tantial diversion of management and other employee resources from our business and may adversely impact our reputation. We may be subj u ect to an inju n nction that prevents or delays us from commercializing our ABC Platform technology, product candidates or other technologies during on-going litigation even if we ultimately prevail in the litigation proceedings or the litigation is settled in our favor. We may be subj u ect to an inju n nction that prevents or delays us from commercializing our ABC Platform, product candidates or other technologies during on-going litigation even if we ultimately prevail in the litigation proceedings or the litigation is settled in our favor. In the event of a successful f claim of infringement against us, we may be enjo n ined from further developing or commercializing our infringing ABC Platform, product candidates or other technologies. In addition, we may have to pay subs u tantial damages (including treble damages and attorneys’ fees for willful f infringement) obtain one or more licenses from third parties, pay royalties and/or redesign our infringing product candidates or technologies, which may be impossible or require subs u tantial time and monetary expenditure. If we were unabl a e to further develop and commercialize our ABC Platform, product candidates or other technologies, it would harm our business significantly.
Kodiak: 2023 Annual Report Page 63 Page 65