AIT Therapeutics, Inc. Enters into a License, Development and Commercialization Agreement with Circassia Limited
January 29, 2019 at 09:05 pm
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AIT Therapeutics, Inc. and Circassia Limited entered into a License, Development and Commercialization Agreement, pursuant to which the company granted Circassia an exclusive royalty-bearing license to distribute, market and sell the company’s nitric oxide generator and delivery system in the United States and China. In consideration of the rights and licenses granted to Circassia by the Company, Circassia shall pay the Company the following milestone amounts are $7.35 million upon signing; $3.15 million payable within five business days following the successful completion of a Food and Drug Administration pre-submission meeting; $12.6 million payable on the sooner of ninety days post FDA approval of the Product or the launch of the Product in the United States, subject to certain requirements; $8.4 million payable within five business days following the approval by the FDA of the Product in certain hospital and clinic settings for use in cardiac surgery; and $1.05 million payable within five business days following approval by the FDA equivalent in China for marketing and sale of the Product. In addition, Circassia shall pay the Company the following royalty amounts until expiration of all of the applicable patents a one-time 5% royalty on the first cumulative $50 million in gross profit in the United States; a one-time 5% royalty on the first cumulative $20 million in gross profit in China; Thereafter, running royalty amounts of 15% of annual gross profit (United States & China combined) up to and including $100 million and 20% of annual gross profit (United States & China combined) exceeding $100 million. Following expiration of the patents, Circassia shall pay for the continued of Company technology a 14% royalty on annual gross profits up to and including $100 million and a 19% royalty on annual gross profits exceeding $100 million.
Beyond Air, Inc. is a commercial stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. The Company has received United States Food and Drug Administration (FDA) approval for its first system, LungFit PH, for the treatment of term and near-term neonates with hypoxic respiratory failure. It is advancing its other LungFit systems in clinical trials for the treatment of severe lung infections such as viral community-acquired pneumonia (including COVID-19), and nontuberculous mycobacteria (NTM) among others. It has also partnered with The Hebrew University of Jerusalem to advance a pre-clinical program dedicated to the treatment of autism spectrum disorder (ASD) and other neurological disorders. Its approved product and active pipeline of product candidates include LungFit PH, LungFit PRO and LungFit GO.