Commitments and Contingencies | 12. Commitments and Contingencies Lease Commitments The Company has historically entered into lease arrangements for its facilities. The Company has one operating lease for its office and laboratory facility with required future minimum payments as of March 31, 2024 and one operating lease that was terminated in August 2022. On May 16, 2022, the Company entered into an office and laboratory lease in Boston, MA with an initial 10-year term and one renewal option to extend the lease for an additional seven years . The lease commenced on August 1, 2022 , and estimated payments due under the initial term total $ 35.2 million. The lease requires a letter of credit totaling $ 0.8 million which is classified as long-term restricted cash and deposits on the consolidated balance sheet. The landlord will reimburse the Company up to $ 0.5 million for certain costs related to expansion of the laboratory space. As of March 31, 2024, the Company has incurred $ 0.1 million of expenses related to the expansion, and has been reimbursed for $ 0.1 million of these expenses. The following table contains a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s leases for the three months ended March 31, 2024 and 2023 (in thousands): Three Months Ended 2024 2023 Lease Cost Operating lease costs 868 881 Variable lease costs 361 309 Short-term lease costs — 2 Total lease costs $ 1,229 $ 1,192 Cash paid for amounts included in the measurement of lease liabilities—operating leases $ 751 $ 768 Weighted-average remaining lease term—operating leases (years) 8.34 9.34 Weighted-average discount rate—operating leases 10.71 % 10.71 % The following table reconciles the future minimum commitments to the Company’s operating lease liabilities at March 31, 2024 (in thousands): Operating lease payments as of March 31, 2024 2024 $ 2,070 2025 3,306 2026 3,405 2027 3,507 2028 3,612 Thereafter 13,823 Total lease payments 29,723 Less: interest ( 10,403 ) Total lease liabilities at March 31, 2024 19,320 Less: current portion of lease liabilities 2,741 Lease liabilities, net of current portion $ 16,579 License Agreements The Company has entered into the following key agreements that relate to the core technology under development: Rakuten License and Supply Agreement In May 2024, the Company received notice from LI-COR, Inc., or LI-COR, that as of April 16, 2024, LI-COR assigned, and Rakuten Medical, Inc., or Rakuten, assumed, the 2014 Exclusive Agreement and the 2014 Non-Exclusive Agreement (each described below), each originally entered into by and between the Company and LI-COR. The 2014 Exclusive Agreement and 2014 Non-Exclusive Agreement were not otherwise modified by this assignment and assumption and remain in effect. 2014 Exclusive Agreement In January 2014, the Company entered into an Exclusive License and Supply Agreement, or the 2014 Exclusive Agreement, with LI-COR for the license of IRDye 700DC and related licensed patent (now expired) for the treatment and diagnosis of ocular cancers in humans, as amended in January 2016, July 2017, April 2018 and April 2019. The 2014 Exclusive Agreement required a one-time upfront license issue fee of $ 0.1 million and aggregate milestone payments of up to $ 0.2 million upon certain regulatory and development milestones. The Company is also required to pay Rakuten low-single digit royalties on net sales. The term of the 2014 Exclusive Agreement expires on a country-by-country basis, until the longer of (i) ten years from the first commercial sale of a licensed product in such country and (ii) the last to expire valid claim in such country . The Company recognized no expenses related to this agreement and related amendments for the three months ended March 31, 2024 and 2023, respectively. 2014 Non-Exclusive Agreement In December 2014, the Company entered into a Non-Exclusive License Agreement, or the 2014 Non-Exclusive Agreement, with LI-COR for the supply of IRDye 700DX to the Company for the treatment and diagnosis of non-ocular solid tumor cancers in humans. Under the 2014 Non-Exclusive Agreement, the Company paid a license issue fee of $ 0.03 million on the effective date. The Company must also pay Rakuten a non-refundable, non-creditable fee of $ 0.03 million per each licensed product upon pre-IND designation, as defined of such licensed product, aggregate milestone payments of up to $ 0.3 million upon certain regulatory and development milestones; and during the term, the Company must pay Rakuten a low-single digit percentage royalty on net sales. Rakuten receives 10% of all sublicensee income within 30 days of the Company’s receipt from the sublicensee. The 2014 Non-Exclusive Agreement also required the Company to make certain payments upon the achievement of specified development and commercial milestones of up to $ 0.4 million in aggregate . During the three months ended March 31, 2024 and 2023 , the Company recognized no milestones related to this agreement. Life Technologies Corporation License Agreements In December 2014, the Company entered into a non-exclusive, perpetual license agreement with Life Technologies Corporation, or the Life Technologies, which allows for five licensed products. Under this agreement the Company is required to pay an initial license fee of $ 0.1 million for each product. An annual development fee of $ 0.1 million is due within a year from payment of the initial license fee and due annually or earlier of (i) payment of a commercialization fee or (ii) all development work is terminated. The commercialization fee is a one-time, non-refundable, non-creditable fee of $ 0.3 million due upon receipt of approval of a licensed product. In the event of a change of control, there will be a change of control fee of $ 0.2 million. In January 2022, the Company entered into the First Amendment to the non-exclusive, perpetual license agreement with Life Technologies for use of the license in an additional indication. The cost of this amendment was a one-time fee of $ 0.05 million. During the three months ended March 31, 2024 and 2023 , the Company recognized $ 0.02 million of expenses related to this agreement, respectively. Effective in September 2022, the Company entered into a new non-exclusive, perpetual license agreement with Life Technologies for licensed products. Under this agreement, the Company is required to pay an initial license fee of $ 0.4 million for the first licensed product and $ 0.5 million for each additional licensed product. In addition, the agreement allows the Company the right to sublicense which would lead to a $ 0.2 million payment for each sublicense per licensed product and a $ 0.03 million payment for use of the cell line document package. In the event of a change of control, there will be a change of control fee of $ 0.5 million. During the three months ended March 31, 2024 and 2023, the Company recognized no expenses related to this agreement. National Institute of Health (NIH)-Collaboration Research and Development Agreement In July 2011, the Company entered into a Collaboration Research and Development Agreement, or CRADA, with Dr. John Schiller at the NIH, for a period of two years with the rights to an exclusive license to all technology generated within the collaboration. Under this agreement, the Company is required to make annual payments of $ 0.03 million to fund the research activities, the first payment of which was paid within 30 days of the effective date. Subsequent payments are due within 30 days of the anniversary of the effective date. This agreement was first amended in 2012, 2013, 2014, 2015, 2016, 2018 and in September of 2020. During the three months ended March 31, 2024 and 2023, the Company paid no research collaboration fees related to this agreement. A seventh amendment was made in October 2020, requiring payment of $ 0.04 million within 30 days of October 1, 2020, and another $ 0.03 million within 30 days of the 10th anniversary of the CRADA, which was paid in July 2021. This seventh amendment extended the term of the CRADA to September 30, 2022. The Company recognized no milestones related to this agreement and related amendments for the three months ended March 31, 2024 and 2023. An eighth amendment was effective in September 2022, requiring payment of $ 0.04 million within 30 days of November 1, 2022, and payment of another $ 0.03 million within 30 days of the 12th anniversary of the CRADA, which was in August 2023. This eighth amendment extended the term of the CRADA to September 30, 2024. During the three months ended March 31, 2024 and 2023, the Company recognized no expenses related to this agreement. National Institute of Health (NIH)-Exclusive Patent License Agreement In September 2013, the Company entered into an exclusive patent license agreement, or the NIH Exclusive License Agreement, with the NIH, that required the Company to pay a license issue royalty of $ 0.1 million and reimburse the NIH for any patent expenses incurred. Under the agreement, the Company is required to make low single-digit percentage royalty payments based on specified levels of annual net sales of licensed products subject to certain specified reductions. The Company is required to make development and regulatory milestone payments of up to $ 0.7 million in aggregate and sales milestone payments up to $ 0.6 million in the aggregate. The Company is also required to pay the NIH a mid-single to low teen-digit percentage of any sublicensing revenue the Company receives. Additionally, the Company’s payment obligations to the NIH are subject to an annual minimum royalty payment of low five figures. The Company recognized no patent licensing fees for the three months ended March 31, 2024 and 2023, respectively. In 2015, 2018 and 2019, the Company amended its exclusive patent license to include updates on the status of the commercial development and update/expand the list of licensed patents and patent applications. Each of those amendments required a $ 0.03 million payment that the Company paid. Inserm-Transfert License Agreement In November 2009, the Company entered into an exclusive, royalty-bearing patent license agreement with Inserm-Transfert of France. The agreement expires on a country by country basis based on the last to expire any patent encompassed within the scope of the patent rights or 10 years from the date of the first commercial sales by the Company, whichever is later. The IND filing milestone of € 0.01 million was accrued in 2016 and paid in 2017 by the Company. The milestones for the successful Phase I, II and III clinical trials are based on receiving a final report and achieving the primary endpoints defined in that trial, and those milestones have not been achieved as of March 31, 2024. Upon the sublicense by the Company of a product for which royalties are payable under the agreement, low- to mid-single-digit royalty payments would be due by the Company. The non-milestone payments in this agreement are subject to an anti-stacking clause. The Company did no t incur any expense in the three months ended March 31, 2024 and 2023. Clearside License Agreement In July 2019, the Company entered into an exclusive license agreement, or the Clearside License Agreement, with Clearside Biomedical, Inc., or Clearside, for the license of Clearside’s Suprachoroidal Microneedle Technology for use in the treatment of indeterminate lesions and choroidal tumors. Upon execution of the Clearside License Agreement, the Company paid Clearside an upfront payment of $ 0.1 million which was expensed as incurred. Under the Clearside License Agreement, the Company is required to pay milestones up to $ 21.0 million in the aggregate upon the achievement of specified regulatory and development milestones, and upon the achievement of certain commercial sales milestones. The Company is also required to pay low to mid-single digit royalties on net sales. If the Company sublicenses a product for which royalties are payable, then the Company is required to pay the greater of 20 % received or low single digit royalties on net sales . The Clearside License Agreement expires on a country-by-country basis upon the later of the last to expire patent or ten years from the date of the first commercial sale of a product . The Company recognized no expense related to this agreement and related amendments for the three months ended March 31, 2024 and 2023 . |