Item
1.01 Entry into a Material Definitive Agreement
On
June 26, 2023 SYBLEU INC. ( the “Company”) was granted an exclusive worldwide license by DYO Biotechnologies, Pty, Ltd (“DYO”)
to (a) to make, have made, use, offer for sale, sell, perform, have performed export and import Licensed Products and Licensed Services;
(b) to practice Licensed Methods; and (c) to use Technology, all in the Field, within the Territory and during the Term (the “License”).
“Technology”
is defined in the License as” Artificial intelligence/machine learning engine designed to utilize existing chemical library structures
in an integrated model to predict highly specific and sensitive novel chemical structures for molecular targets.”
“Licensed Products” are defined in the License as “any product, kit, composition, or part thereof: (a) that incorporates,
uses, or is enabled or derived from the use of the Technology; or (b) that is produced or enabled by a Licensed Method.”
“Licensed
Services” are defined in the License as “any service performed by Company or Sublicensee for the benefit of a third party
that, in whole or in part, (a) uses Technology; (b) uses Licensed Product(s); or (c) that practices or is enabled by a Licensed Method.”
“Licensed
Method” is defined in the License as “any method or process that uses Technology”
“Field”
is defined in the License as small molecule drug development and commercialization for human and/or animal health.
“Territory” is defined in the License as “worldwide”.
The Term of the License is the period of time beginning on the effective date of this Agreement which shall be June 26, 2023 and terminating
on the last to expire Royalty Term .
“Royalty
Term” is defined in the License as that period of time beginning on the first commercial sale of a Licensed Product in a given
country and, expires on a country-by-country basis with respect to each Licensed Product, upon the later of: (a) the expiration, abandonment,
or invalidation of the last to expire, abandoned or invalidated Valid Claim of the Patent Rights in such country; (b) the expiration
of any granted statutory period of marketing exclusivity within a country; and (c) 12 years from of the date of the first commercial
sale of such Licensed Product in such country.
Pursuant
to the terms and conditions of the License the Company shall raise $2,000,000 US through either debt or equity financing within 2 years
of execution of this Agreement (“Funding”). The Company shall enter into a research collaboration agreement with DYO upon
mutually acceptable terms and conditions within 30 days of Funding (“Research Agreement).
Substantially
all of the Funding shall be utilized to enable the Technology for the benefit of developing Company’s existing and future small
molecule drug intellectual property. It is anticipated that this research agreement will utilize substantially all of these funds over
two years. It is agreed that the Company shall exclusively possess all right, title and interest in and to including, but not limited
to, the copyrights, trade secrets, trademarks and associated good will and patent rights to any and all inventions, discoveries, intellectual
property and chemical structures resulting from this Research Agreement.
Pursuant
to the terms and conditions of the License the Company shall pay to DYO a Royalty equal to five percent (5%) of the Net Sales ( as such
term is defined in the License) of any Licensed Method, Service or Product per annum. The License also imposes an obligation upon the
Company to make minimum royalty payments to DYO over the course of the Term.
Pursuant
to the terms and conditions of the License the l Company shall pay to DYO , at the Company’s sole discretion, either (a) 309,000
common shares of the Company or (b) 309,000 shares of a newly authorized class of stock which shall automatically convert on a one to
one basis into common shares of the Company on that date which shall be two years from the date of issuance (“Stock Payment”).
DYO
shall not, directly or indirectly, offer, issue, sell, contract to sell (including without limitation short sale), grant any option for
the sale of, pledge or otherwise dispose of or transfer any or all of the Stock Payment for a period of two years from the date of issuance.
Pursuant
to the terms and conditions of the License Upon the occurrence of each of the following events (each a “Milestone”)), the
Company shall make a cash payment (“Milestone Payment”) in the amount corresponding to such Milestone within thirty days
after achievement of each Milestone:
| Milestone |
AMOUNT |
| 1.
Dosing of a first human patient in a Phase I or Phase I/II Clinical Trial for Licensed Product |
$150,000
US |
| 2.
Dosing of a first patient in a Phase III Clinical Trial for Licensed Product |
$500,000
US |
| 3.
FDA (US) Approval of a Licensed Product |
$3,000,000
US |
| 4.
EMA (EU) Approval of a Licensed Product |
$1,500,000
US |
| 5.
PMDA (JPN) Approval of a Licensed Product |
$1,000,000
US |
| 6.
Cumulative Net Sales of Licensed Products reach $100 Million |
$2,000,000
US |
This
License may be terminated by DYO in the event:
No
licensed Method, Service or Product has been granted Patent Protection in at least one jurisdiction after the expiration of four years
from execution
The
sum of $2,000,000 shall not have been raised within 2 years of execution of the license
The
Research Agreement shall not have been entered into as of thirty days subsequent to the Funding.
The
Company shall not have achieved cumulative Net Sales of Licensed Product, Service and Methods of at least $10,000,000 as of a date that
is ten years from the execution of the license
The
Company shall fail to pay any consideration required under the license and such failure remains uncured for thirty days.
This
License may be terminated by the Company in the event:
DYO
shall be determined to not have exclusive unencumbered Patent Rights to the Technology in whole or in part.
Any
other entity shall be determined to have the right- exercised or not- to utilize the Technology ( in whole or in part) to develop make,
use, offer for sale, sell, perform, have performed export and import and sell products, methods and services which can reasonably be
expected to be similar to or competitive with products, methods and services to be developed by the Company utilizing the rights granted
by the License. .
DYO
shall have failed to demonstrate during the course of due diligence to the satisfaction of the Company that the Technology can be effectively
utilized for the purposes intended by this License
In
the event that the Agreement is terminated pursuant to the any of the abovementioned the Stock Payment shall be promptly returned by
DYO to the Company for cancellation.
Dr.
Harry Lander serves as Chief Scientific Officer of the Company and is a shareholder of the Company. Dr. Harry Lander also serves as Managing
Director of DYO and is a controlling shareholder of DYO.
The
foregoing description of the abovementioned License Agreement is not complete and is qualified in its entirety by reference to the text
of the abovementioned License Agreement, which is attached to this Current Report on Form 8-K as Exhibit 10.1 and incorporated in this
Item 1.01 by reference.
Item
9.01 Exhibits.