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. During 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 were 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 had 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 condensed 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 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 11036114 Canada Inc. (initially dba VJO Non-Clinical Development and now dba Strategy Point Innovations ("SPI")) 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 SPI were sub-contracted to ITR under substantially the same terms as the initial contract with ITR, with fees payable for services under statements of work that are currently open totaling $3,607,000, as amended. During the three and nine months ended September 30, 2020, the Company recorded research and development costs of approximately $0 and $779,000, respectively. During the three and nine months ended September 30, 2019, the Company recorded research and development costs of approximately $843,000 and $2,597,000, 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 approximately $3,089,000, as amended, with additional pass-through costs. During the three and nine months ended September 30, 2020, the Company recorded research and development costs of approximately $249,000 and $1,266,000, respectively. During the three and nine months ended September 30, 2019, the Company recorded research and development costs of approximately $288,000 and $346,000, respectively. 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 approximately $1,079,000, as amended, with additional pass-through costs. During the three and nine months ended September 30, 2020, the Company recorded research and development costs of approximately $384,000 and $626,000, respectively. During the three and nine months ended September 30, 2019, the Company recorded research and development costs of approximately $177,000 and $295,000, respectively. In August 2019, the Company entered into a master services agreement and associated individual study contracts with Conform Clinical Development, Inc. and its affiliates, Les Entreprises Envie Inc. (dba Envie Ventures) and Desire Ventures LLC, which sub-contracted with Inflamax Research Limited (dba Cliantha Research) to perform a Phase I study of one of the Company's drug candidates, Voriconazole. The fees payable for the services under this contract total approximately $1,483,000, as amended. During the three and nine months ended September 30, 2020, the Company recorded research and development costs of approximately $709,000 and $934,000, respectively. During the three and nine months ended September 30, 2019, the Company recorded research and development costs of approximately $281,000. In January 2020, TFF Australia entered into a master consultancy agreement with Novotech (Australia) Pty Ltd. (formally known as Clinical Network Services Pty Ltd.) to provide initial contract clinical research and development services for the Company's drug product candidates. The fees payable for clinical research and development services under these study contracts totaled AUD$1,942,981, as amended. During the three and nine months ended September 30, 2020, the Company recorded research and development costs of approximately AUD$139,000 (US$99,000) and AUD$323,000 (US$218,000), respectively. In May 2020, TFF Australia entered into an amended clinical trial research agreement with Nucleus Network Pty Ltd. to provide a Phase I study of one of the Company's drug candidates, Tacrolimus. The fees payable for services under this contract totaled AUD$1,392,805, as amended. During the three and nine months ended September 30, 2020, the Company recorded research and development costs of approximately AUD$61,000 (US$44,000) and AUD$437,000 (US$295,000), respectively. In August 2020, TFF Australia entered into a clinical trial research agreement with Q-Pharm Pty Ltd. to provide a Phase I study of one of the Company's drug candidates, Tacrolimus. The fees payable for services under this contract totaled AUD$704,600. During the three and nine months ended September 30, 2020, the Company recorded research and development costs of approximately AUD$327,000 (US$234,000). On August 12, 2020, the Company entered into a licensing and collaboration agreement with UNION therapeutics A/S in which UNION acquired an option to obtain a worldwide exclusive license for the TFF technology in combination with niclosamide. Pursuant to the terms of the license agreement, UNION can exercise its option to obtain the license within 45 days after the complete data has been received by UNION from investigator-initiated trials. Upon exercise of the option, UNION shall be responsible to pay all expenses incurred in the development of any licensed product. The Company will be eligible to receive milestone payments upon the achievement of certain milestones in the development the licensed products, based on completion of clinical trials, pre-marketing approvals and/or the receipt of at least $25,000,000 of grant funding. The Company will receive a single-digit tiered royalty on net sales. The Company will also be entitled to receive sales-related milestone payments based on the commercial success of the licensed products. |