XML 41 R11.htm IDEA: XBRL DOCUMENT v3.19.3.a.u2
License and Agreements
9 Months Ended
Sep. 30, 2019
License and Agreements [Abstract]  
License and Agreements

Note 5 — License and Agreements

 

In July 2015, the University of Texas at Austin ("UT") granted to TFF'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 assigned to TFF 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, TFF and UT amended the patent license agreement to expand TFF's exclusive patent rights to the TFF platform to all fields of use. The patent license agreement requires TFF 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 nine months ended September 30, 2019, the Company did not achieve any of the milestones and, as such, was not required to make any milestone payments. As of the date of these financial statements, the Company is in compliance with the patent license 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 $270,000, with no minimum fee requirement. During the three and nine months ended September 30, 2019, the Company recorded costs associated with this agreement of $3,000 and $81,000, respectively. During the three and nine months ended September 2018, the Company recorded costs associated with this agreement of $52,450 as research and development costs. There is no additional work ongoing at this time.

 

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 totalled $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 totalling $4,104,000, as amended. During the three and nine months ended September 30, 2019, the Company recorded research and development costs of $843,280 and $2,596,535, respectively. During the three and nine months ended September 30, 2018, the Company recorded research and development costs of $7,525 and $495,409, 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 $420,000, with additional pass-through costs. During the three and nine months ended September 30, 2019, the Company recorded costs associated with this agreement of $288,000 and $346,000, respectively, 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 $812,232, with additional pass-through costs. During the three and nine months ended September 30, 2019, the Company recorded costs associated with this agreement of $177,000 and $295,000, respectively, 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 $1,258,000, as amended. During the three and nine months ended September 30, 2019, the Company recorded costs associated with this contract of $281,000, as research and development costs.