On January 25, 2022, Bolt Biotherapeutics, Inc. (the "Company") reported that entered into an amended and restated supply agreement with EirGenix, Inc. (the "Amended Supply Agreement"), which amends the original supply agreement with EirGenix, Inc. ("EirGenix") dated March 10, 2019, pursuant to which EirGenix agreed to supply to the Company, on a non-exclusive basis, bulk drug substance of EG12014, its monoclonal antibody being developed as a biosimilar of trastuzumab, which the Company uses in the manufacture of its BDC-1001 HER2 Boltbody ISAC (Filing, 8-K, Bolt Biotherapeutics, JAN 25, 2022, View Source [SID1234606766]). The Amended Supply Agreement, among other things, requires the constitution of a joint steering committee, amends the forecasting schedules and methods of addressing any order delays or cancellations, and adjusts supply pricing based on the scale of production. The remaining terms and conditions under the Amended Supply Agreement remained substantially the same as the original supply agreement.
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Under the Amended Supply Agreement, EirGenix provides the Company with its regulatory data package containing the sections of chemistry, manufacturing and control of drug substance EG12014 to facilitate the Company’s development and commercialization efforts, and the Company is required to make milestone payments to EirGenix up to an aggregate of $2.0 million based upon achievement of certain regulatory milestones by the Company’s HER2 Boltbody ISAC. The agreement will remain in effect as long as the Company, or any of its affiliates or licensees, continue to pursue the development or commercialization of any Boltbody ISAC containing drug substance EG12014, unless earlier terminated in accordance with the terms of the Amended Supply Agreement.