52 Any future changes to patent laws could increase the uncertainties and costs surrounding the prosecution of our owned or in-licensed patent applications and the enforcement or defense of our owned or in-licensed issued patents. If a third party were to prevail on a legal assertion of invalidity or unenfor f ceabi a lity, we would lose at least part, and perhaps all, of the patent protection on our ABC Platform, product candidates or other technologies. Increased uncertainty with respect to, or loss of,f patent protection would have a material adverse impact on our business, financial condition, results of operations and prospects. If we do not obtai t n i paten t t term extension and datat exclusivityt for any n product candid d at d es t we may a develop, l our busine i ss may a be materially l harmed.d Depending upon the timing, duration and specifics of any FDA marketing approval of any product candidates we may develop, one or more of our owned or in-licensed U.S. patents may be eligible for limited patent term extension under the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent term extension of up to five years as compensation for patent term lost during the FDA regulatory r review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent may be extended and only those claims covering the approved drug, r a method for using it, or a method for manufact f ur t ing it may be extended. Similar extensions as compensation for patent term lost during regulatory r review processes are also availabl a e in certain foreign countries and territories, such as in Europe under a Suppl u ementary Patent Certific f ate. Patent term extension in the United States and/or foreign countries and territories may not be availabl a e if,f among other things, we fail to exercise due diligence during the testing phase or regulatory r review process, fail to apply within applicable deadlines, fail to apply prior to the expiration of relevant patents, or otherwise fail to satisfy f applicable requirements. Moreover, the applicable time period or the scope of patent protection affo f rded could be less than we request. If we are unabl a e to obtain patent term extension or the term of any such extension received is shorter than what we request, our competitors may obtain approval of competing products following our patent expiration, and our business, financial condition, results of operations and prospects could be materially harmed. We may a be subject to clai l ms i challe l nging the inventorship of our paten t ts and othe t r intellectual property. t We may be subj u ect to claims that former employees, collabor a ators or other third parties have an interest in our owned or in-licensed patents, trade secrets or other intellectua t l property as an inventor or co-inventor or owner or co-owner. For example, we may have inventorship disputes arise from conflic f ting obligations of employees, collabor a ators, consultants or others who are involved in developing our ABC Platform, product candidates or other technologies. Litigation may be necessary to defend against these and other claims challenging inventorship or our ownership of our owned or in-licensed patents, trade secrets or other intellectual property. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of,f or right to use, intellectual property that is important to our ABC Platform, product candidates and other technologies. Even if we are successful in defending against such claims, litigation could result in subs u tantial costs and be a distraction to management and other employees. Any of the foregoing could have a material adverse effe f ct on our business, financial condition, results of operations and prospects. If we are unablel to protec t t the confid f en d tiality i of our trade secrets, t our busine i ss and competitiv t e positio t n wouldl be harmed.d In addition to seeking patents for our ABC Platform, product candidates and other technologies, we also rely on trade secrets and confid f entiality agreements to protect our unpatented know-how, technology and other proprietary information and to maintain our competitive position. Trade secrets and know-how can be difficult to protect. Over time, we expect our trade secrets and know-how to be disseminated within the industry r through independent development, the publ u ication of journal articles describing the methodology and the movement of personnel from academic to industry r scientific f positions.
Kodiak: 2023 Annual Report Page 61 Page 63