12. LICENSE AGREEMENTS AND DISCOVERY COLLABORATIONS License Agreements Lerociclib – G1 In July 2020, the Company entered into a license agreement with G1 Therapeutics (“G1”), under which it acquired an exclusive license for the research, development, and commercialization of lerociclib for the treatment, using an oral-only dosage administration by continuous administration, for any and all indications in humans through the inhibition of CDK4/6 worldwide, with the exception of Australia, Bangladesh, Hong Kong Special Administration Region, India, Indonesia, Macau Special Administration Region, Malaysia, Myanmar, New Zealand, Pakistan, mainland China, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand and Vietnam (the “G1 Territory”). The license agreement also provided the Company with a non-exclusive license in the G1 Territory to manufacture lerociclib for purposes of obtaining regulatory approval for, and commercialization of lerociclib for the treatment, using an oral-only dosage administration, by continuous administration for any and all indications in humans through the inhibition of CDK4/6 outside of the G1 Territory. On August 1, 2023, the Company provided written notice to G1 of its termination of the license agreement. The parties have commenced transition activities. Under the terms of the license agreement, the Company received an exclusive license to develop lerociclib using an oral-only dosage administration by continuous administration for any and all indications in humans through the inhibition of CDK4/6 at its own cost and expense in the Company’s territory. The Company is also required to reimburse G1 for any costs G1 incurs in the Company’s territory during the term of the license agreement for development activities that were ongoing at the time the license agreement became effective. The Company was required to make an upfront non-refundable, non-creditable payment of $20.0 million to G1. If the Company had succeeded in developing and commercializing lerociclib, G1 would have been eligible to receive (i) up to $40.0 million in development and regulatory milestone payments, and (ii) up to $250.0 million in sales milestone payments. G1 was also eligible to receive royalties on worldwide net sales of any products containing lerociclib, which ranged from mid-single digits to mid-teens, subject to potential reduction following the launch of certain generic products. The royalties would have expired on a product-by-product and country-by-country basis until the later to occur of (i) the expiration of all valid patent claims covering lerociclib in a country, and (ii) 10 years following the first commercial sale of lerociclib in a country. The Company had the right to terminate the license agreement with G1 for any or no reason upon at least 90 days prior written notice to G1, which it did on August 1, 2023. Either party could have also terminated the license agreement in its entirety for the other party’s material breach if such other party had failed to cure the breach. Either party could have also terminated the agreement in its entirety upon certain insolvency events involving the other party. The Company evaluated the license agreement with G1 under ASC 805, Business Combinations, and concluded that the transaction did not meet the requirements to be accounted for as a business combination and therefore was accounted for as an asset acquisition. Aumolertinib — Hansoh In July 2020, the Company entered into a collaboration and license agreement with Hansoh (Shanghai) Healthtech Co., LTD. and Jiangsu Hansoh Pharmaceutical Group Company LTD. (“Hansoh”) (as amended on December 14, 2021) under which it acquired an exclusive license for the research, development, and commercialization of aumolertinib, a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), worldwide, with the exception of mainland China, Hong Kong, Macau and Taiwan (the “Hansoh Territory”). The license agreement also provided the Company with a non-exclusive license in the Hansoh Territory to research, develop and export aumolertinib for purposes of obtaining regulatory approval for, and commercialization of aumolertinib for use outside of the Hansoh Territory. On August 1, 2023, the Company provided written notice to Hansoh of its termination of the license agreement. The parties have commenced transition activities. Under the terms of the license agreement, the Company received an exclusive license to develop aumolertinib for any and all uses for the treatment of cancer, cancer-related and immune-inflammatory diseases in humans at its own cost and expense in the Company’s territory. The Company was obligated to make an upfront, non-refundable, non-creditable payment of $25.0 million. If the Company had succeeded in developing and commercializing aumolertinib, Hansoh would have been eligible to receive (i) up to $90.0 million in development and regulatory milestone payments, and (ii) up to $420.0 million in sales milestone payments. In the event that Hansoh elected to opt out of sharing certain global development costs in accordance with the terms of the license agreement, the total potential development and regulatory payments Hansoh would have been eligible to receive would have been reduced to $55.0 million, and the total potential sales milestone payments would have been reduced to $350.0 million. Hansoh would have also been eligible to receive royalties on worldwide net sales of any products containing aumolertinib, which ranged from mid-single digits to low teens, subject to potential reduction following the launch of certain generic products. The royalties for aumolertinib would have expired on a product-by-product and country-by-country basis upon the latest to occur of (i) the expiration of all valid patent claims covering the compounds in a country, (ii) the expiration of all regulatory exclusivities for aumolertinib in a country, and (iii) 11 years following the first commercial sale of aumolertinib in a country. The Company had the right to terminate the license agreement with Hansoh for any or no reason upon at least 180 days prior written notice to Hansoh, which it did on August 1, 2023. Either party could have also terminated the license agreement in its entirety for the other party’s material breach if such other party failed to cure the breach. Either party could also have terminated the agreement in its entirety upon certain insolvency events involving the other party. The Company evaluated the license agreement with Hansoh under ASC 805 and concluded that the transaction did not meet the requirements to be accounted for as a business combination and therefore was accounted for as an asset acquisition. During the six months ended June 30, 2023, the Company recognized $0.5 million of research and development expenses in the condensed consolidated statement of operations and comprehensive income (loss) upon the achievement of certain development milestones. Sugemalimab/Nofazinlimab — CStone In October 2020, the Company entered into a license agreement with CStone Pharmaceuticals (“CStone”) (as amended on August 15, 2022) under which it acquired an exclusive license for the research, development, and commercialization of CStone’s sugemalimab, an anti-PD-L-1 monoclonal antibody, and nofazinlimab, an anti-PD-1 monoclonal antibody, worldwide, with the exception of mainland China, Taiwan, Hong Kong and Macau (the “CStone Territory”). The Company had the right to terminate the license agreement with CStone for any or no reason upon providing prior written notice to CStone, which it did on May 8, 2023. In June 2023, the Company and CStone entered into a transition agreement altering the effects of termination under the CStone license agreement and terminating the license agreement as of June 5, 2023, subject to certain agreed upon transition activities to be performed after such date. The Company has estimated and recorded contract termination costs in the restructuring line in the Company’s condensed consolidated statements of operations and comprehensive income (loss), refer to note 8. Other Licenses Prior to the three months ended June 30, 2023, the Company had two other license agreements under which it had acquired exclusive licenses for the research, development and commercialization of preclinical and clinical compounds from pharmaceutical and/or biotechnology companies. During the three months ended June 30, 2023, the Company terminated the two other license agreements. The Company has estimated and recorded contract termination costs in the restructuring line in the Company’s condensed consolidated statements of operations and comprehensive income (loss), refer to note 8. Discovery Collaboration Agreements The Company entered into a number of discovery collaboration agreements with leading drug engineering companies pursuant to which the Company agreed to collaborate with certain collaboration partners (the “Partners”) to identify, discover and develop innovative therapeutics for agreed upon targets, with the goal of expanding the Company’s pipeline of therapies (the “Collaboration Agreements”). Pursuant to the Merger Agreement, the Company is taking steps to terminate or opt-out of all of its existing Collaboration Agreements. Pursuant to the Collaboration Agreements, as between the parties, the Partners generally perform the discovery, profiling, preclinical and investigational new drug application (“IND”) enabling studies (the “Research Activities”) for all potential candidates. Once a candidate was identified and selected for further development (the “Collaboration Product”), the Company would have been generally responsible for all activities required to develop and commercialize the Collaboration Product. In general, the Company and the Partners would have equally shared costs (including research, development, and commercialization) and profits (losses) with respect to each Collaboration Product. All activities performed under the Collaboration Agreements are overseen by joint steering committees established under each Collaboration Agreement and made up of an equal number of participants from the Partner and the Company. Decisions by the joint steering committee are generally made by consensus. Pursuant to each Collaboration Agreement, the term generally continues throughout the development and commercialization of the Collaboration Products, on a product-by-product basis, until the expiration of the last payment obligation by one of the parties to the other or their earlier termination. The Collaboration Agreements are considered to be within the scope of ASC 808, Collaborative Arrangements, as the agreements represent a joint operating activity and both the Partners and the Company are active participants and exposed to the risks and rewards. The Company has evaluated the Collaboration Agreements and determined they do not fall within the scope of ASC 606, Revenue from Contracts with Customers, as the Partners do not meet the definition of a customer. The Company recognized approximately $6.2 million and $5.6 million of research and development expenses associated with Collaboration Agreements in its condensed consolidated statements of operations and comprehensive income (loss) during the three months ended June 30, 2023 and 2022, respectively, and $13.8 million and $11.4 million, during the six months ended June 30, 2023 and 2022, respectively.
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