Burzynski Research Institute Inc 8-K, filed May 22, 2023
Burzynski Research Institute Inc (BZYR)
About this 8-K
Burzynski Research Institute Inc filed this 8-K on May 22, 2023.
Items reported
- Item 1.01: Entered into a material agreement
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 1.01 | Entry into a Material Definitive Agreement. |
License Agreement
On May 22, 2023, Burzynski Research Institute, Inc. (the “Company”) entered into a License Agreement (the “License Agreement”) with Dr. Stanislaw R. Burzynski (“Dr. Burzynski”), pursuant to which Dr. Burzynski licensed to the Company the exclusive rights in the Territory (composed of the United States and Canada) to make, have made, use, sell, offer for sale, and distribute or otherwise exploit the licensed products and services relating to Antineoplastons, including but not limited to any patent rights which may be granted in these countries. The License Agreement currently covers four United States patents owned by Dr. Burzynski (the “US Patents”). The first of these US Patents includes the patent which was originally issued to the Company on May 31, 2022 and re-assigned to Dr. Burzynski in early 2023, covering methods for the treatment of leptomeningeal disease using Antineoplaston. The second of these US Patents includes the patent issued to Dr. Burzynski on March 21, 2023, also covering methods for the treatment of leptomeningeal disease using Antineoplaston. The third of these US Patents includes the patent issued to Dr. Burzynski on April 21, 2020, covering methods for the treatment of recurrent glioblastoma (RGBM). The fourth of these US Patents includes the patent issued to Dr. Burzynski on February 1, 2022, covering methods for the treatment of glioblastoma multiforme. Additionally, there are two pending Canadian patent applications (covering methods for the treatment of leptomeningeal disease and methods for the treatment of recurrent glioblastoma), and one pending United States patent applications (covering methods for the treatment of glioblastoma multiforme).
The License Agreement will terminate upon the earlier of the expiration of the last patent licensed to the Company, or termination by Dr. Burzynski, at his option, if he is removed as a director or officer of the Company without his consent, if the Company files for bankruptcy or is the subject of any proceeding under applicable bankruptcy laws where such proceeding is not dismissed within 90 days from the date a petition is filed, or if any shareholder or group of shareholders acting in concert becomes the beneficial owner of the Company’s securities having voting power equal to or greater than the voting power of the securities Dr. Burzynski holds. The License Agreement grants Dr. Burzynski the limited right to manufacture, use, sell, distribute and otherwise exploit Antineoplastons in the Company’s exclusive territory solely in connection with the treatment of patients in Dr. Burzynski’s medical practice until such date that the FDA may approve the sale of Antineoplastons for the treatment of cancer in the United States.
Amended and Restated Research Funding Agreement
On May 22, 2023, the Company also entered into the amended and restated research funding agreement (the “Amended Research Funding Agreement”) with Dr. Burzynski, pursuant to which the parties amended and restated the original Research Funding Agreement dated March 1, 1997, as amended, in connection with the execution of the License Agreement and to limit the scope of the Amended Research Funding Agreement to the United States and Canada. The term of the Amended Research Funding Agreement was renewed and extended until February 29, 2024, which is also automatically renewable for an additional one year term unless one party notifies the other party at least thirty days prior to the expiration of the term of the agreement of its intention not to renew the agreement.
Amended and Restated Royalty Agreement
On May 22, 2023, the Company also entered into the amended and restated royalty agreement (the “Amended Royalty Agreement”) with Dr. Burzynski, pursuant to which the parties amended and restated the original Royalty Agreement dated March 25, 1997, as amended, in connection with the execution of the License Agreement and to limit the scope of the Amended Research Funding Agreement to the United States and Canada.
Dr. Burzynski currently serves as the Chairman of the Board and the Chief Executive Officer of the Company.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 10.1 | License Agreement, dated May 22, 2023, by and between the Company and Dr. Stanislaw R. Burzynski. | |
| 10.2 | Amended and Restated Research Funding Agreement, dated May 22, 2023, by and between the Company and Dr. Stanislaw R. Burzynski. | |
| 10.3 | Amended and Restated Royalty Agreement, dated May 22, 2023, by and between the Company and Dr. Stanislaw R. Burzynski. | |
| 104 | Cover Page Interactive File (the cover page tags are embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: May 22, 2023 | BURZYNSKI RESEARCH INSTITUTE, INC. | |
| By: | /s/ Stanislaw R. Burzynski | |
| Stanislaw R. Burzynski | ||
| President and Chairman of the Board of Director | ||
Exhibit 10.1
LICENSE AGREEMENT
LICENSE AGREEMENT dated May 22, 2023, by and between Dr. Stanislaw R. Burzynski ("Dr. Burzynski") with offices at 9432 Katy Freeway, Suite 200, Houston, Texas 77055 and Burzynski Research Institute, Inc. (the "Company"), a Delaware corporation with offices located at 9432 Katy Freeway, Suite 200, Houston, Texas 77055.
W I T N E S S E T H :
WHEREAS, Dr. Burzynski owns and controls certain rights, title and interests to patents and patent applications relating to the use of antineoplastons, as well as certain testing procedures to diagnose, treat and evaluate cancer in patients; and
WHEREAS, the Company and Dr. Burzynski desire to enter into a License (“Agreement”) by the terms hereof such that the Company can acquire the Licensed Rights set forth below.
NOW, THEREFORE, in consideration of the foregoing and the mutual covenants and agreements herein contained, the parties hereto agree as follows:
1. For purposes of this Agreement, "Licensed Rights" shall be defined as the Patent Rights and the Technology Rights. The Patent Rights shall be defined as the patents, patent applications and any subsequently issued patents for antineoplastons (“Antineoplastons”) and any testing procedures for Antineoplastons to be set forth on Schedule A hereto as amended from time to time, including any divisions, continuations and continuations-in-part as well as any reexaminations, re-issues, inter partes review of these patent applications and patents issued thereof within the United States and Canada (“Territory”). The Technology Rights shall be defined as the know-how relating to the manufacture, use, sale, and distribution of Antineoplastons and any testing procedures for Antineoplastons within the Territory.
2. “Licensed Products and Services” shall be defined as any product, service, procedure or method covered by one or more valid claims within the Patent Rights within the Territory or that rely upon the Technology Rights within the Territory.
3. Dr. Burzynski hereby grants to the Company a fully paid-up, exclusive license under the Licensed Rights to make, have made, use, sell, offer for sale, and distribute or otherwise exploit the Licensed Products and Services within the Territory. The Company may grant sublicenses to others worldwide but only to the extent that such sublicense directly supports Company’s activities within the Territory under the Licensed Rights and to exploit the Licensed Products and Services.
4. Notwithstanding anything herein contained to the contrary, Dr. Burzynski shall be entitled to manufacture, use, sell, distribute and otherwise exploit Licensed Products and Services in the Territory solely in connection with the treatment of patients in Dr. Burzynski’s medical practice until the date on which the United States Federal Drug Administration approves the sale of Antineoplastons for the treatment of cancer in the United States.
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5. This Agreement shall continue until the earlier of the expiration of the last patent included within the Licensed Rights or the termination of this Agreement according to the provisions of paragraph 7 hereof.
6. During the term of this Agreement, Dr. Burzynski and the Company agree to make available to the other party all research and results thereof, and other information obtained by each party concerning Licensed Products and Services as such relate to the treatment of cancer in compliance with all State and Federal Law regarding patient privacy.
7. This Agreement may be terminated by Dr. Burzynski under the following circumstances:
a) Bankruptcy Proceedings. Dr. Burzynski may terminate this Agreement in the event the Company files for bankruptcy or is the subject of any proceeding under applicable bankruptcy laws and such proceeding against the Company is not dismissed or discharged within ninety (90) days from the date a petition for bankruptcy is filed.
b) Removal as Officer/Director. This Agreement may be terminated in the event Dr. Burzynski is removed as the President and/or director of the Company without his consent, except where he has been removed for cause by a court of competent jurisdiction. If Dr. Burzynski is no longer able to serve as the President and/or director of the Company by reason of death or disability, his departure from such offices shall not be deemed to be removal for the purposes of this subparagraph.
c) Voting Power. This Agreement may be terminated in the event a person acquires the direct or indirect beneficial ownership of securities of the Company having voting power equal to or greater than the voting power of securities of the Company held directly by Dr. Burzynski or his executors, administrators, successors and heirs; however, this provision shall not apply in the event Dr. Burzynski has made a voluntary transfer or sale of more than 20% of the securities held directly by him. For purposes of this subparagraph, the term "person" shall include a natural person, company, government, or instrumentality of a government and any two or more persons with beneficial ownership and acting as a partnership, limited partnership, syndicate, or other group for the purpose of acquiring, holding, controlling, or disposing of any security of the Company. The term "beneficial ownership" shall have the meaning set forth in Rule 13d-3 of the General Rules and Regulations under the Securities Exchange Act of 1934, as such Rule is in effect on the date hereof.
8. Dr. Burzynski shall bear all costs for the filing, prosecution, issuance and maintenance of the patents and patent applications included in the Licensed Rights and the Company may prepare, file, and prosecute at its expense any application for a division, continuation, continuation-in-part, or reissue or inter partes review of the patents and patent applications included in the Licensed Rights.
9. If a third party infringes on a claim of a patent included in the Licensed Rights, Dr. Burzynski has the sole and exclusive right, but not the obligation, to enforce the Licensed Rights and settle any disputes with third parties without regard and without the consent of Company. If necessary to maintain standing in any enforcement action, Company hereby agrees to join any such enforcement action and to provide reasonable cooperation. If Dr. Burzynski fails to exercise his right under this paragraph 9, the Company may enforce the patents against third party infringers at its own expense. If in a Company initiated enforcement action, Dr. Burzynski is a necessary party to establish standing, then Dr. Burzynski will join as a party at Company’s expense.
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10. This Agreement is not assignable by either party without the express written consent of the other party. Anything herein to the contrary notwithstanding, this Agreement shall inure to the benefit of Dr. Burzynski’s executors, administrators, successors and heirs and the provisions of this Agreement, with the exception of paragraph 7(c) shall be binding upon such executors, administrators, successors and heirs to the same extent that it was binding upon Dr. Burzynski at the time of his death.
11. This Agreement is to be governed and construed in accordance with the laws of the State of Delaware.
12. This Agreement constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior understandings or agreements, oral or written, and shall not be changed or terminated orally. There are no understandings, representations or warranties of any kind not expressly set forth herein or incorporated herein by reference.
13. The failure of a party to insist upon strict adherence to any provision of this Agreement on any occasion shall not be considered a waiver or deprive that party of the right thereafter to insist upon strict adherence to that provision or any other provision of this Agreement.
14. If any provision of this Agreement shall be deemed invalid or unenforceable, the balance of this Agreement shall remain in effect, and if any provision shall be deemed inapplicable to any person or circumstance, it shall nevertheless remain applicable to all other persons and circumstances.
15. The Company has full capacity, power and authority to execute, deliver and perform this Agreement. The Company’s execution, delivery and performance of this Agreement has been duly and validly authorized by the Company’s board of directors.
| /s/ Stanislaw R. Burzynski | |
| Stanislaw R. Burzynski | |
| Dated: May 22, 2023 |
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| BURZYNSKI RESEARCH INSTITUTE, INC. | ||
| By: | /s/ Stanislaw R. Burzynski | |
| Stanislaw R. Burzynski, | ||
| President | ||
| Dated: May 22, 2023 | ||
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SCHEDULE A
| Country | Serial No. | Patent No. | Filing Date | Title |
| US | 16/622,230 | 11,607,397 | 12/12/2019 | METHODS FOR THE TREATMENT OF LEPTOMENINGEAL DISEASE |
| US | 17/079,207 | 11,344,521 | 10/23/2020 | METHODS FOR THE TREATMENT OF LEPTOMENINGEAL DISEASE |
| CA | 3,067,026 | N/A | 06/11/2018 | METHODS FOR THE TREATMENT OF LEPTOMENINGEAL DISEASE |
| US | 15/589,887 | 10,624,869 | 05/08/2017 | METHODS FOR THE TREATMENT OF RECURRENT GLIOBLASTOMA (RGBM) |
| CA | 3,062,741 | N/A | 05/07/2018 | METHODS FOR THE TREATMENT OF RECURRENT GLIOBLASTOMA (RGBM) |
| US | 16/843,850 | 11,234,951 | 04/08/2020 | METHODS FOR THE TREATMENT OF GLIOBLASTOMA MULTIFORME |
| US | 17/587,197 | N/A | 01/28/2022 | METHODS FOR THE TREATMENT OF GLIOBLASTOMA MULTIFORME |
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Exhibit 10.2
AMENDED AND RESTATED RESEARCH FUNDING AGREEMENT
THIS AMENDED AND RESTATED AGREEMENT (the "Agreement”) effective as of May 22, 2023, by and between Stanislaw R. Burzynski, M.D. Ph.D (hereinafter "SRB") with offices at 9432 Katy Freeway, Suite 200, Houston, Texas 77055 and Burzynski Research Institute, Inc. (the "Company"), a Delaware corporation with offices located at 9432 Katy Freeway, Suite 200, Houston, Texas 77055:
W I T N E S S E T H :
WHEREAS SRB owns all right, title and interest to certain patents and patent applications directed to, among other things, methods of using antineoplastons in the treatment of cancer (“Patent Rights”); and
WHEREAS SRB has granted BRI an exclusive license under the Patent Rights pursuant to a License Agreement dated May 22, 2023 (the “License Agreement”) to make, have made, use, sell, offer for sale, and distribute or otherwise exploit, antineoplastons for the treatment of cancer in the United States and Canada; and
WHEREAS none of these antineoplastons formulations are currently approved for interstate marketing by the U.S. Food and Drug Administration, ("FDA"); and
WHEREAS it is mutually advantageous that basic science research continue to develop, refine and improve antineoplastons; and
WHEREAS BRI is willing to undertake such research but does not currently have sufficient funds to conduct the research; and
WHEREAS SRB is willing to fund such research until a permanent source of financing is obtained.
NOW THEREFORE the parties agree as follows:
1. BRI to Undertake Research:
BRI agrees to undertake all scientific research (including clinical trials) in connection with the development of (i) new or improved antineoplastons for the treatment of cancer and other diseases, and (ii) methods of treatment for cancer using antineoplastons. BRI will hire and supervise such personnel as is required to fulfill its obligations under this agreement to conduct the research (including clinical trials).
2. SRB to Fund Research:
a. Funding Commitment:
(i) Basic Research costs:
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SRB agrees to fund in its entirety all basic research which BRI undertakes in connection with the development of other antineoplastons or refinements to existing antineoplastons for the treatment of cancer and other diseases.
(ii) FDA related costs:
As FDA approval of antineoplastons will benefit both parties, SRB agrees to pay the expenses for the clinical trials department of BRI.
(iii) Research and lab space SRB agrees to provide BRI such laboratory and research space as BRI needs at the Trinity Drive facility in Stafford, Texas, and such office space as is necessary in the Trinity Drive facility and at his medical facility, at no charge to BRI.
(iv) SRB may fulfill his obligations in part by providing such administrative staff as is necessary for BRI to manage its business, at no cost to BRI.
b. Budget and payment of expenses:
SRB agrees to pay the monthly and annual budget of expenses for the operation of BRI as mutually agreed between the parties, together with such other unanticipated but necessary expenses which BRI incurs. Payments from SRB to BRI of the monthly budget shall be made in two equal installments on the first and fifteenth of each month.
3. Ownership of Future Patents:
In the event the research described herein results in the approval of any additional patents, SRB shall own all such patents, but shall license to BRI the patents based on the same terms, conditions and limitations as is in the License Agreement.
4. SRB's Use of BRI Equipment:
SRB shall have unlimited and free access to all equipment which BRI owns or controls, so long as such use is not in conflict with BRI's use of such equipment, including without limitation all equipment used in the manufacturing of antineoplastons used in the clinical trials.
5. Reductions of Payments and Setoffs:
The amounts which SRB is obligated to pay under this Agreement shall be reduced dollar for dollar by:
a. Any income which BRI receives for services provided to other companies for research and/or development of other products, less such identifiable marginal or additional expenses necessary to produce such income (such as the purchase of chemicals, products or equipment solely necessary to engage in such other research and development activity).
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b. the net proceeds of any stock offering or private placement which BRI receives during the term of this Agreement, up to a maximum of $1,000,000 in a given BRI fiscal year.
6. Term of Agreement:
The initial term of this Agreement shall be one year. This Agreement shall be automatically renewed for successive one-year terms, unless one party notifies the other party at least thirty days prior to the expiration of such term.
7. Automatic Termination:
This Agreement shall automatically terminate in the event that SRB owns less than fifty percent of the outstanding shares of BRI, or is removed as President and or Chairman of the Board of BRI, unless SRB notifies BRI in writing of his intention to continue this Agreement notwithstanding this automatic termination provision.
8. Termination of Prior Agreement:
This Agreement is intended to supersede, amend and restate the Research Funding Agreement between the parties dated March 1, 1997, as amended.
IN WITNESS WHEREOF the parties have executed this Agreement.
EXECUTED this 22nd day of May 2023.
| /s/ Stanislaw R. Burzynski | ||
| Stanislaw R. Burzynski | ||
| BURZYNSKI RESEARCH INSTITUTE, INC | ||
| By: | /s/ Stanislaw R. Burzynski | |
| Stanislaw R. Burzynski, President | ||
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Exhibit 10.3
AMENDED AND RESTATED ROYALTY AGREEMENT
THIS AMENDED AND RESTATED AGREEMENT (the "Agreement") made and entered into May 22, 2023 by and between STANISLAW R. BURZYNSKI, M.D., Ph.D. ("BURZYNSKI") with offices at 9432 Katy Freeway, Suite 200, Houston, Texas 77055 and Burzynski Research Institute, Inc. (the "Company"), a Delaware corporation with offices located at 9432 Katy Freeway, Suite 200, Houston, Texas 77055.
WHEREAS, the parties have heretofore entered into a Royalty Agreement dated March 25, 1997 and a First Amended Royalty Agreement dated September 29, 1997 (collectively, the "Original Agreement"); and
WHEREAS, this Agreement is intended to supersede, amend and restate the Original Agreement in its entirety; and
WHEREAS, BURZYNSKI is the owner of certain patents dealing with certain medical chemical compounds and uses thereof all of which relate to antineop1aston drugs; and
WHEREAS, antineoplastons are still investigational new drugs not approved for interstate marketing by the Federal Food and Drug Administration; and
WHEREAS, on May 22, 2023, BURZYNSKI and BRI entered into a license agreement (the "License Agreement”) wherein BURZYNSKI licensed all of those patents set forth in the License Agreement to BRI so that BRI now has the sole right to make, have made, use, sell, offer for sale, and distribute or otherwise exploit antineoplastons in the United States and Canada; and
WHEREAS, pursuant to said License Agreement, BURZYNSKI has the right to continue to use antineoplastons in his private medical practice until the FDA approves antineoplaston for the treatment of cancer;
WHEREAS, it would be of significant and direct benefit to BRI for antineoplastons to be approved by the FDA for interstate marketing so that BRI could either sell, distribute, license or otherwise exploit antineoplastons on a national scale; and
WHEREAS, BURZYNSKI has in the past and is willing to continue to conduct his medical practice in such a way as to develop the data necessary to support the FDA approval of the drug for interstate marketing; and
WHEREAS, BURZYNSKI is willing to continue in his efforts to provide the FDA the data in order to approve the drug, inter alia, by being the clinical investigator of FDA-approved clinical trials which trials are necessary for the approval of any drug; and
WHEREAS, BURZYNSKI is currently the principal investigator for several FDA-approved clinical trials of antineoplastons, and his undertaking of such clinical trials may significantly shorten the time in which antineoplastons can be approved by the FDA.
NOW, THEREFORE, the parties agree as follows:
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1. BURZYNSKI TO CONTINUE AS PRINCIPAL INVESTIGATOR:
BURZYNSKI agrees to continue in his role as the principal investigator in all current and such future clinical trials as is necessary to create the data to support the approval of antineoplastons for interstate marketing. Furthermore, BURZYNSKI also agrees to conduct such other and additional clinical trials as may be required by the FDA to support a new drug application and approval for interstate marketing. Furthermore, BURZYNSKI agrees to supervise, consult, oversee and otherwise deal with any other matters that come up with the FDA approval process, such as the drafting and oversight of additional clinical trials by other investigators in general, Burzynski agrees to use his best and continuous efforts to ensure that antineoplastons are approved by the FDA as soon as possible.
2. Prior to FDA new drug approval (“NDA”) BURZYNSKI and BRI will operate under the terms of the “Amended and Restated Research Funding Agreement” effective May 22, 2023. After FDA NDA approval or Canadian regulatory approval, BRI shall produce all antineoplaston products to be sold or distributed in the U.S. and Canada, as applicable, for the treatment of cancer.
3. BURZYNSKI shall have the right to either lease or purchase all the manufacturing equipment located at 12707 Trinity Drive, Stafford, Texas at a fair market price to be determined by independent appraisal.
4. BRI shall have the right to lease from BURZYNSKI the entire premise located at 12707 Trinity Drive, Stafford, Texas at arms-length terms at rates competitive with those available in the market at the time, provided that BURZYNSKI does not need the facility for his use.
5. COMPENSATION:
In consideration for BURZYNSKI undertaking and continuing to perform those responsibilities outlined in Paragraph 1 above, BRI hereby assigns and agrees to assign BURZYNSKI a royalty interest equivalent to l0% (ten percent) of BRI's gross income (excluding licensing fees generated by BURZYNSKI licensing payments to BRI), which royalty interest shall include gross receipts from all future sales, distribution and manufacture of antineoplastons. BURZYNSKI will not pay any royalty fees to BRI for the right to produce antineoplaston products for the use in his medical practice. The parties acknowledge that there is no such income at this time and unless antineoplastons are approved for interstate marketing in the United States, there may never be such income.
6. BURZYNSKI CONTINUED USE OF ANTINEOPLASTONS AFTER FDA APPROVAL:
As additional consideration, BRI hereby accords BURZYNSKI the right to continue to use antineoplastons in his private medical practice, after any and all formulations of antineoplastons are approved for interstate marketing by the FDA on the same terms arid conditions, and royalty schedule as is currently in effect under the License Agreement. BURZYNSKI shall retain the right to either a) produce antineoplaston products to use in his medical practice to treat up to 1,000 patients, or b) purchase antineoplaston products from BRI for use in his medical practice to treat up to 1,000 patients, where the price to be paid by BURZYNSKI to BRI will be BRI’s cost plus 10%.
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7. TERM OF AGREEMENT:
The term of this Agreement shall be indefinite and will continue until such time as the parties agree that it is in their mutual interest to terminate such agreement.
EXECUTED this 22nd day of May 2023.
| /s/ Stanislaw R. Burzynski | ||
| Stanislaw R. Burzynski | ||
| BURZYNSKI RESEARCH INSTITUTE, INC. | ||
| By: | /s/ Stanislaw R. Burzynski | |
| Stanislaw R. Burzynski, | ||
| President | ||
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