Quarterly report pursuant to Section 13 or 15(d)

COMMITMENTS AND CONTINGENCIES

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COMMITMENTS AND CONTINGENCIES
3 Months Ended
Jul. 31, 2021
Commitments and Contingencies Disclosure [Abstract]  
COMMITMENTS AND CONTINGENCIES

 

9. COMMITMENTS AND CONTINGENCIES

 

Contractual Obligations

 

On May 1, 2016, the Company entered into a Standard Exclusive License Agreement for AL002 with Sublicensing Terms with the University of South Florida Research Foundation, Inc., as licensor, pursuant to which the licensor granted the Company a royalty bearing exclusive worldwide license limited to the field of Alzheimer’s Immunotherapy and Diagnostics, under United States Patent No. 8,188,046, entitled “Amyloid Beta Peptides and Methods of Use,” filed April 7, 2009 and granted May 29, 2012.

 

In addition to royalty payments of 4% on net sales of products developed from the licensed technology, the Company was required to pay a license fee of $100,000 on June 25, 2016, and December 31, 2016. As an additional licensing fee for the license of the AL001 technologies, the licensor received 2,227,923 shares of the Common Stock. Additionally, the Company is required to pay milestone payments on the due dates to the licensor for the license of the technology, as follows:

Schedule of payment and due date to the licensor for the license 

Original AL001 License:

 

Payment     Due Date   Event
$ 50,000      Completed September 2019    Pre-IND meeting
             
$ 65,000      6 months from the June 30, 2021 IND filing date    IND application filing
             
$ 190,000      12 months from the June 30, 2021 IND filing date    Upon first dosing of patient in a clinical trial
             
$ 500,000      12 months from first patient dosing    Upon Completion of first clinical trial
             
$ 1,250,000      12 months from completion of the first Phase II clinical trial    Upon first patient treated in a Phase III clinical trial
             
$ 10,000,000      8 years from the effective date of the agreement    Upon FDA approval

 

 

 AL002 License:

  

Payment     Due Date   Event
$ 50,000      Upon IND application filing    Upon IND application filing
             
$ 50,000      12 months from IND application filing date    Upon first dosing of patient in first Phase I clinical trial
             
$ 175,000      12 months from first patient dosed in Phase I    Upon completion of first Phase I clinical trial
             
$ 500,000      24 months from completion of first Phase I clinical trial    Upon completion of first Phase II clinical trial
             
$ 1,000,000      12 months from completion of the first Phase II clinical trial    Upon first patient treated in a Phase III clinical trial
             
$ 10,000,000      7 years from the effective date of the agreement    Upon FDA BLA approval

 

 

The Company has met the Pre-IND meeting and IND application filing milestones encompassing AL001. If the Company fails to meet a milestone by its specified date, the licensor may terminate the license agreement. 

 

The licensor was also granted a preemptive right to acquire such shares or other equity securities that may be issued from time to time by the Company while the licensor remains the owner of any equity securities of the company.

 

 

There are certain license fees and milestone payments required to be paid pursuant to the terms of the Standard Exclusive license agreements with Sublicensing Terms, both effective July 2, 2018, (the “AL001 license agreements”) with the licensor and the University of South Florida. In addition, a royalty payment of 3% is required pursuant to License #18110 while License #1811 requires a royalty payment of 1.5% on net sales of products developed from the licensed technology. For the two AL001 licenses, in the aggregate, the Company was required to pay initial license fees of $50,000 no later than July 31, 2018, and $150,000 no later than October 31, 2018. As an additional licensing fee, the licensor is entitled to receive that number of shares of the Company’s common stock equal to 3% of the sum of the total number of issued and outstanding shares. Additionally, the Company is required to pay milestone payments on the due dates to the licensor for the license of the technology, as follows:

 

Additional AL001 Licenses:

 

Payment     Due Date   Event
$ 30,000      Completed September 2019    Pre-IND meeting
             
$ 50,000      December 31, 2022    IND application filing
             
$ 150,000      12 months from IND filing date    Upon first dosing of patient in a clinical trial
             
$ 400,000      12 months from first patient dosing    Upon Completion of first clinical trial
             
$ 1,000,000      36 months from completion of the first Phase II clinical trial    Upon first patient treated in a Phase III clinical trial
             
$ 8,000,000      8 years from the effective date of the agreement    First commercial sale