LICENSE AND AGREEMENTS | NOTE 5 - LICENSE AND AGREEMENTS In July 2015, the University of Texas at Austin ("UT") granted to the Company's former parent, LTI, an exclusive worldwide, royalty bearing license to the patent rights for the TFF platform in all fields of use, other than vaccines for which LTI received a non-exclusive worldwide, royalty bearing license to the patent rights for the TFF platform. In March 2018, LTI completed an assignment to the Company all of its interest to the TFF platform, including the patent license agreement with UT, at which time the Company paid UT an assignment fee of $100,000 in accordance with the patent license agreement. In November 2018, the Company and UT entered into an amendment to the patent license agreement pursuant to which, among other things, the Company's exclusive patent rights to the TFF platform were expanded to all fields of use. The patent license agreement requires the Company to pay royalties and milestone payments and conform to a variety of covenants and agreements, and in the event of the Company's breach of agreement, UT may elect to terminate the agreement. For the period ended December 31, 2018, the Company did not achieve any of the milestones and, as such, was not required to make any milestone payments. For the year ended December 31, 2019, the Company achieved one milestone by gaining IND approval on first indication of a licensed product on November 24, 2019. The milestone fee associated with this achievement to be paid is $50,000 and the Company must issue UT common shares equal to 1% of the Company's outstanding shares of common stock, on a fully diluted basis, as of 30 days after IND approval, which was December 24, 2019. The total amount of common shares due and payable on December 31, 2019 to UT are 220,666 common shares, which have a fair value of approximately $1,132,000 based on the closing stock price of $5.13 on December 24, 2019. As of December 31, 2019, the Company has not paid the $50,000 or issued the shares and has included the $50,000 in accounts payable and the share amount due as a research and development expense payable. The Company paid the $50,000 and issued the shares in January 2020. As of the date of these consolidated financial statements, the Company is in compliance with the patent license agreement as all required amounts have been paid in accordance with the agreement. In June 2018, the Company entered into a one-year agreement with Patheon Development Services, Inc. to provide initial contract manufacturing services for the Company's drug product candidates. The fees payable for contract manufacturing services under this agreement total $273,000, with no minimum fee requirement. During the years ended December 31, 2019 and 2018, the Company recorded costs associated with this agreement of $81,000 and $192,000, respectively, as research and development costs. In May 2018, the Company entered into a master services agreement and associated individual study contracts with ITR Canada, Inc. ("ITR") to provide initial contract pre-clinical research and development services for the Company's drug product candidates. The fees payable for pre-clinical research and development services under these study contracts totaled $1,790,000, with no minimum fee requirement. In January 2019, the Company cancelled all of the individual study contracts with ITR and entered into a contract with Canada Inc. (dba VJO Non-Clinical Development ("VJO")) to complete additional pre-clinical research and development services in order to take advantage of eligible Canadian Tax Credits. The services related to the contract with VJO were sub-contracted to ITR under substantially the same terms as the initial contract with ITR, with fees payable for the services under this contract totaling $4,412,000, as amended. During the years ended December 31, 2019 and 2018, the Company recorded research and development costs of approximately $2,745,000 and $273,000, respectively. In April 2019, the Company entered into a master services agreement with Irisys, LLC to provide contract manufacturing services for one of the Company's drug product candidates, Voriconazole. The fees payable for contract manufacturing services under this agreement total $1,352,000, as amended, with additional pass-through costs. During the year ended December 31, 2019, the Company recorded costs associated with this agreement of approximately $886,000 as research and development costs. In June 2019, the Company entered into a master services agreement with CoreRx to provide contract manufacturing services for one of the Company's drug product candidates, Tacrolimus. The fees payable for contract manufacturing services under this agreement total $918,794, as amended, with additional pass-through costs. During the year ended December 31, 2019, the Company recorded costs associated with this agreement of approximately $290,000 as research and development costs. In August 2019, the Company entered into a master services agreement and associated individual study contracts with Conform Clinical Development, Inc. and its affiliate, Les Entreprises Envie Inc. (dba Envie Ventures), which sub-contracted with Inflamax Research Limited (dba Cliantha Research ("Cliantha")) to perform a Phase 1 study of one of the Company's drug candidates, Voriconazole. The fees payable for the services under this contract total approximately $1,258,400, as amended, as amended. During the year ended December 31, 2019, the Company recorded costs associated with this contract of approximately $977,000 as research and development costs. |