Item
1.01 ENTRY INTO A MATERIAL DEFINITVE AGREEMENT.
On
February 23, 2023, the Company entered into a Commercial License Agreement (the “License Agreement”) with Inspirevax Inc.
(“Inspirevax”) pursuant to which Inspirevax granted the Company an exclusive worldwide license to use Inspirevax’s
inventions, patents, trade secrets, know-how, copyright, biological material, designs, and/or technical information created by or on
behalf of Inspirevax (the “Inspirevax Technologies”) relating to its novel lipid-protein based intranasal adjuvants, to make,
research, and develop an intra-nasal vaccine in combination with an antigen (“Combination Product”) to be used in an intranasal
vaccine for use against diseases caused by coronaviruses and any genetic variants thereof to be sold by us.
As
consideration for the grant of the license, the Company will pay an upfront signing fee of $50,000. The Company will be subject to certain
milestone payments as follows: (a) $75,000 upon the Company’s decision on an appropriate nasal spray device, (b) $100,000 upon
a first patient being dosed in a phase 2a clinical trial, (c) $200,000 upon a first patient being dosed in a Phase 2b/3 clinical trial,
(d) $800,000 upon a biologics License Application being submitted to the FDA, (e) $400,000 upon first filing of marketing authorization
outside of the United States, and $200,000 for each such additional filing up to five filings, (f) $2,000,000 upon first commercial sale
in the United States, (g) $1,000,000 upon first commercial sale in Europe, (h) $500,000 upon first commercial sale outside of United
States and Europe and $250,000 for each other country or region up to five. Additionally, during the term the Company will pay to Inspirevax
a 7% royalty on net sales subject to certain gross revenue limitations at which time the royalty will decrease to 4%.
The
Company will be required to use its best efforts to develop a product using the Inspirevax technology including the following: (a) first
subject enrollment in first clinical study by December 31, 2023, (b) the first subject enrolled in a Phase 2a study by September 30,
2024, (c) first subject enrolled in a phase 3 registration trial by December 31, 2026, and (d) first marketing approval application submitted
by June 30, 2028.
Pursuant
to the License Agreement, Inspirevax is required to bear the responsibility and pay the costs to obtain and maintain patents related
to the Inspirevax Technologies.
Pursuant
to the License Agreement, any and all intellectual property rights in any invention conceived, reduced to practice, or developed during
the Term of the License Agreement solely arising from or solely related to the Combination Product or the antigen will be owned by the
Company, and the Company will bear the responsibility and pay the costs to obtain and maintain patents related to these inventions.
Pursuant
to the License Agreement, the Company is required to indemnify and hold Inspirevax and its employees and agents harmless from and against
all liability and damages in connection with or arising out of all claims, demands, losses, damages, costs including solicitor and client
costs, actions, suits or proceedings brought by any third party that are in any manner based upon, arising out of, related to, occasioned
by, or attributable to the manufacturing, distribution, shipment, offering for sale, sale, or use of Products, services based on the
Inspirevax Technologies and product liability and infringement of intellectual property rights other than copyright, if any, licensed
under the License Agreement.
Unless
terminated earlier, the License Agreement will terminate the later of (i) twenty (20) years from the first commercial sale of a product,
(ii) the last date a product is covered by a valid patent claim, or (iii) the expiration of regulatory exclusivity. The Company may terminate
the License Agreement, by giving thirty (30) days written notice to Inspirevax. Either party may terminate, if the other party defaults
or is in breach of the License Agreement, provided that if the defaulting party cures the breach within sixty (60) days after the notice
is given, the License Agreement shall continue in full force and effect. The License Agreement contains customary confidentiality obligations.
The
companies will form a Joint Development Committee (JDC) comprising representatives of both companies to oversee the development efforts
collaboratively. Additionally, the agreement provides a certain period of time for the companies to expand their collaboration to pursue
the development of additional intranasal vaccine candidates using Inspirevax’s adjuvants.
On
March 1, 2023, Oragenics, Inc. issued a press release announcing an exclusive Global License Agreement with Inspirevax to Develop Intranasal
Covid Vaccine Candidate. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.