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License Agreements

12 Months Ended

Dec. 31, 2019

Note 3—License agreements

The following summarizes the Company's research and development expenses for licenses acquired during the years ended December 31, 2019 and 2018:

	For the Years Ended December 31,
	2019		2018
Chelexa BioSciences, Inc.	$	-	$	132,164
The George Washington University		2,500		-
University of Maryland and Isoprene Pharmaceuticals, Inc.		10,000		-
North Carolina State University		25,000		-
University of Cincinnati		7,500		7,500
Zylö Therapeutics Inc.		50,000		-
Other		-		91,029
	$	95,000	$	230,693

Chelexa BioSciences, Inc.

On May 26, 2017, the Company entered into a sublicense agreement with Chelexa, as amended on August 22, 2018 and August 29, 2018, pursuant to which Chelexa granted the Company an exclusive sublicense to make, use, have made, import, offer for sale, and sell products based upon or involving the use of (i) topical compositions comprising a zinc chelator and gentamicin and (ii) zinc chelators to inhibit biofilm formation (the "BioLexa Platform" or "BioLexa"), which rights were originally granted to Chelexa pursuant to an exclusive license agreement with the University of Cincinnati. In addition, Chelexa granted the Company the right to issue exclusive and nonexclusive sublicenses (with the right to further sublicense to third parties) to make, use, have made, import, offer for sale, and sell products based upon the BioLexa Platform. The term of such agreement will expire on the later of April 16, 2034 and the last to expire patent in the patent rights granted to the Company (the "Term"). The Company shall, in its sole discretion, have the first right of refusal to renew the Term. The Company is subject to total milestone payments of $3.5 million royalty payments and has agreed to fund all development and commercialization costs related to the licensed products.

During the year ended December 31, 2018, the Company recorded an expense of approximately $0.1 million related to the issuance of 213,166 shares of its common stock pursuant to the sublicense agreement with Chelexa. There were no expenses incurred for the year ended December 31, 2019.

The George Washington University

Effective as of June 1, 2019, the Company and The George Washington University ("GWU") entered into a sponsored research agreement (the "Sponsored Research Agreement"), as amended on July 29, 2019, with respect to the exploration of the potential use of Aprepitant for topical and/or systemic therapy to counter the dermatological related side-effects of Erlotinib therapy in cancer patients. Pursuant to the terms of the Sponsored Research Agreement, GWU granted the Company a non-exclusive, license to certain of GWU's intellectual property. The Company has agreed to pay GWU for all costs incurred in connection with the research; provided, however, such costs shall not exceed approximately $0.3 million. The Sponsored Research Agreement shall terminate on June 30, 2020 unless extended by the parties. The Sponsored Research Agreement may be terminated by either party upon 30 days written notice.

On June 28, 2019 (the "Effective Date"), the Company and GWU entered into a research option agreement (the "Research Option Agreement") pursuant to which GWU granted the Company an option (the "Option") until April 30, 2020 to acquire an exclusive license to certain products made or used by the Company (the "GWU Licensed Product") that involve certain patents owned by GWU (the "Licensed Patents"). On February 1, 2020, the Company exercised the Option and entered into a patent license agreement with GWU. On the Effective Date, the Company paid GWU $2,500, and on February 27, 2020, the Company paid GWU $10,000 as a license initiation fee. Until the first commercial sale of the GWU Licensed Product, the Company shall pay (i) $75,000 per year for the development and commercialization of the GWU Licensed Product, (ii) $2,000 for license maintenance fees on the first anniversary of the Effective Date and (iii) $5,000 for license maintenance fees commencing on the second anniversary of the Effective Date and thereafter. Furthermore, the Company shall be required to pay GWU a sublicense fee equal to a certain percentage of the sum of payments plus the fair market value of all other consideration of any kind received by the Company from sublicensees during each quarter as follows: a 40% sublicense fee until the first anniversary of the Effective Date, a 30% sublicense fee until the third anniversary of the Effective Date and a 20% sublicense fee after the third anniversary of the Effective Date; provided, however, such sublicense fee shall exclude certain fees paid to the Company such as certain royalties, equity investments, loan proceeds and sponsored research funding. Subject to the execution of a definitive license agreement with GWU, the Company shall also pay GWU milestone payments of up to an aggregate of $90,000 and sales based royalties at a low single digit percentage, subject to certain minimum royalty requirements. In addition, during each Option Exercise Period and Renewal Period (as defined in the Research Option Agreement) the Company shall pay GWU, on a quarterly basis, for all costs and expenses related to the GWU Licensed Patents (the "Patent Costs").

In July 2019, after the signing of the Research Option Agreement, the Company recorded an expense of $2,500 for the option fee.

University of Maryland and Isoprene Pharmaceuticals, Inc.

On March 8, 2019, the Company entered into a commercial evaluation sublicense and option agreement with the University of Maryland, Baltimore ("UMD") and Isoprene Pharmaceuticals, Inc. ("Isoprene"). Pursuant to the agreement, the Company paid an initial option and material access fee of $5,000 to UMD and $5,000 to Isoprene. In the event that Isoprene enters into a master license agreement with UMD (the "MLA"), UMD shall permit Isoprene to grant an exclusive option to the Company to negotiate and obtain an exclusive sublicensable, worldwide royalty-bearing license to the subject technology (the "Isoprene-Hoth Option"); provided, however, in the event Isoprene does not enter into the MLA, UMD may grant the Company an option to negotiate and obtain an exclusive sublicensable, worldwide royalty-bearing license to the subject technology (the "UMD-Hoth Option"). If the Company exercises the Isoprene-Hoth Option, it shall pay Isoprene an option exercise fee of $20,000. If the Company exercises the UMD-Hoth Option, it shall pay UMD an option exercise fee of $20,000.

In March 2019, the Company recorded an expense of an aggregate of $10,000 for the initial option and materials access fee.

North Carolina State University

On November 20, 2019 (the "NCSU Effective Date"), the Company entered into a license agreement with North Carolina State University ("NCSU") pursuant to which NCSU granted the Company an exclusive license to, among other things, develop, make, use, offer and sell certain licensed products throughout the world with respect to NCSU's exon skipping approach for treating allergic diseases. The term of the license agreement shall commence on the NCSU Effective Date and shall continue until the date of the expiration of the last to expire patent right granted pursuant to the license agreement unless terminated earlier pursuant to the terms of the agreement. Pursuant to the terms of the license agreement, the Company paid NCSU a one-time license fee $25,000 and is also required to pay (i) sales based royalties at a low single digit percentage, (ii) minimum royalties ranging from $0 to $50,000 and (iii) milestone payments of up to $585,000.

In December 2019, the Company recorded an expense of $25,000 for the license fee.

University of Cincinnati

On May 18, 2018, the Company entered into an exclusive license agreement with the University of Cincinnati for a patented, novel genetic marker for food allergies. The genetic marker licensed by the Company from the University of Cincinnati may be used to (i) identify at risk infants in predicting food allergies, including peanut and milk allergies, (ii) identify a person's predisposition to an allergic reaction, thereby avoiding such reaction and (iii) determine an individual's propensity to develop atopic dermatitis, such as eczema. The Company intends to utilize the genetic marker for purposes of determining an individual's propensity to develop eczema as well as to identify and treat allergies in at-risk infants.

Pursuant to the terms of the exclusive license agreement, the Company agreed to pay the University of Cincinnati a one-time initial fee of $5,000 within 30 days of the date of the exclusive license agreement in addition to an annual license fee of $5,000 initially due and payable within 30 days of the one year anniversary of the exclusive license agreement and every year thereafter. In addition, the Company agreed to pay the University of Cincinnati a yearly annual license maintenance fee of $2,500 and a yearly minimum annual royalty of $5,000 and milestone payments of up to $120,000. The exclusive license agreement will continue until the later of (i) the date upon which a valid claim pursuant to the terms of the exclusive license agreement expires or (ii) 10 years after the first commercial sale or unless earlier terminated pursuant to the terms of the exclusive license agreement.

In August 2018 and July 2019, respectively, the Company recorded an expense of $2,500 for annual license maintenance fee and $5,000 for yearly minimum annual royalty fee, respectively.

Zylö Therapeutics Inc.

On August 19, 2019 (the "Zylö Effective Date"), the Company entered into an exclusive sublicense agreement (the "Sublicense Agreement") with Zylö Therapeutics, Inc. ("Zylö") pursuant to which Zylö granted to the Company an exclusive sublicense to the Licensed Patent Rights (as defined in the Sublicense Agreement) and the Licensed Technology (as defined in the Sublicense Agreement) to, among other things, develop, make and sell the Licensed Products (as defined in the Sublicense Agreement) and to practice the Licensed Technology in the United States and Canada for any and all uses within the Field. "Field" means all therapeutic uses related to lupus in human beings, subject to the Field Expansion Rights (as defined in the Sublicense Agreement). The term of the Sublicense Agreement shall commence on the Zylö Effective Date and shall continue until the latest of (i) ten years from the date of First Commercial Sale (as defined in the Sublicense Agreement) of the Licensed Product in such country and (ii) expiration of the last to expire Valid Claim (as defined in the Sublicense Agreement) of the Licensed Patent Rights that would be infringed by the composition, use or sale of such Licensed Product in such country. Pursuant to the terms of the Sublicense Agreement, the Company and Zylö shall establish a joint development committee to plan, review, coordinate and oversee the Company's development activities with respect to the Licensed Products in the Field. Pursuant to the Sublicense Agreement, the Company paid Zylö (i) an upfront license fee of $50,000; (ii) sales-based royalties at percentages which range from high single digits to low double digits, with low sales volumes being subject to lower royalty rates; and total milestone payments of up to $13.5 million. In addition, within 45 days of the Company's next equity financing pursuant to which the Company receives gross proceeds of at least $1 million, the Company shall purchase equity securities of Zylö in an amount equal to $60,000.

In May 2019 and September 2019, the Company recorded an expense of $10,000 and $40,000, respectively, for upfront license fee.