35 Our product candid d at d es t may a face competiti t on from biologi l cal productst that are biosimilar to or interchangeablel with i our product candid d at d es t sooner than anticipated t .d The Biologics Price Competition and Innovation Act of 2009, or BPCIA, created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product. Under the BPCIA, an application for a biosimilar product may not be subm u itted to the FDA until four years following the date that the reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effe f ctive by the FDA until 12 years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their product. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation and meaning are subj u ect to uncertainty. We believe that any of our product candidates approved as a biological product under a BLA should qualify f for the 12- year period of exclusivity. However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider our product candidates to be reference products for competing products, potentially creating the opportunity for generic competition sooner than anticipated. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subj u ect of recent litigation. Moreover, the extent to which a biosimilar, once approved, will be subs u tituted for any one of our reference products in a way that is similar to traditional generic subs u titution for non-biological products is not yet clear, and will depend on a number of marketpl t ace and regulatory r factors that are still developing. The developm o ent program and timeline i of tarcocimab may a impact our abili i ty i to use the Ursu r s facility i as intended d ,d which couldl result in an excess of capi a ta i l expe x nditu d res. In August 2020, we, together with our wholly owned subs u idiary Kodiak Sciences GmbH, entered into a manufact f ur t ing agreement with Lonza Ltd for the clinical and commercial suppl u y of the Company’s antibody biopolymer conjugate drug r subs u tance, which included a custom-built manufac f turing facility for the potential clinical and commercial suppl u y of tarcocimab, a or the Ursus facility. Fixed assets of $81.7 million, consisting of leasehold improvements and machinery r and equipment, were placed in service and capi a talized as of January 31, 2023. In October 2023, payment was made for the remaining $26.8 million of these fixed assets. In July 2023, we announced a decision to pause further development of tarcocimab, a and then in November 2023, following additional positive clinical trial results, we announced a decision to resume the development of tarcocimab. The development plan, and any further changes thereto, as well as the timeline and success of tarcocimab, a may impact our ability to fully utilize the Ursus facility. We may not realize any benefit from the capi a tal expenditures to date, and we may incur subs u tantial additional expenses and capital expenditures to repurpos r e the Ursus facility for our other product candidates or for use by third parties, any of which may negatively impact our operating results and financial condition. Even if we are successful f utilizing the Ursus facility, our manufact f ur t ing capabilities could be affe f cted by cost-overruns r , additional changes in our development plans, unexpected delays, equipment failures, labor a shortages, natural disasters, power failures and numerous other factors that could prevent us from realizing the intended benefits of our manufact f ur t ing strategy and have a material adverse effe f ct on our business. Any problems in our manufact f ur t ing process or facilities could make us a less attractive collaborator for potential partners, including larger pharmaceutical companies and academic research institut t ions, which could limit our access to additional attractive development programs. If pr f oduct liabili i ty i lawsuits i are brough u t agains i t us,s we may a incur substantia t l liabili i tie i s and may a be required to lil m i iti commercializatio t n of our product candid d at d es t . We face an inherent risk of product liabi a lity as a result of the clinical testing of our product candidates and will face an even greater risk when and if we commercialize any products. For example, we may be sued if our product candidates cause or are perceived to cause inju n ry or are found to be otherwise unsuitabl a e during clinical testing, manufact f ur t ing, marketing or sale. Any such product liabi a lity claims may include allegations of defects in manufact f ur t ing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liabi a lity or a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successful f ly defend ourselves against product liability claims, we may incur subs u tantial liabi a lities or be required to limit testing and commercialization of our product candidates. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in: • decreased or interrupt r ed demand for our products; • inju n ry to our reputation; • withdrawal of clinical trial participants and inability to continue clinical trials; • initiation of investigations by regulators;