UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
April 27, 2020 (April 21, 2020)
AIM IMMUNOTECH INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001 - 27072 | 52-0845822 | ||
| (state or other jurisdiction | (Commission | (I.R.S. Employer | ||
| of incorporation) | File Number) | Identification No.) |
| 2117 SW Highway 484, Ocala FL | 34473 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (352) 448-7797
AIM ImmunoTech Inc.
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company [ ]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol | Name of each exchange on which registered | ||
| Common Stock, par value $0.001 per share | AIM | NYSE American |
Item 1.01 Entry into a Material Definitive Agreement.
On April 21, 2020, AIM entered into a Mutual Confidentiality Agreement with UMN Pharma Inc., Japan National Institute of Infectious Diseases, and Shionogi & Co., Ltd. (collectively, the “Entities”) for the purpose of evaluation and discussion for certain business relationships concerning a COVID-19 therapeutic and vaccine. Current discussions with the Entities are preliminary and we anticipate that, if the parties determine to proceed, initial activity will consist of preclinical animal studies of Ampligen.
We have filed herewith as Exhibit 10.1, the Mutual Confidentiality Agreement, which is incorporated herein by reference, and the foregoing description of the Agreement is qualified in its entirety by reference thereto.
Cautionary Statement
This report and the Mutual Confidentiality Agreement filed as Exhibit 10.1 contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. For example, the Agreement with the Entities, along with other confidentiality agreements we have entered into or may enter into in the future, are just the first step in seeking to work with parties that we believe can further the development of Ampligen and we cannot assure that any activities with these parties will proceed further. While the Company anticipates that the Entities will proceed and that initial activity will consist of preclinical animal studies of Ampligen, no assurance can be given that the parties will proceed or that any preliminary studies will prove promising. Moreover, substantial additional testing will be required, and no assurance can be given that any such studies will demonstrate that Ampligen will be effective in as a COVID-19 therapeutic or vaccine. Generally, with regard to COVID-19, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen will be efficacious in humans. Some of the world’s largest pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. With regard to the Company’s activities with Ampligen generally, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. There also is the potential for delays in clinical trial enrollment and reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency. Any forward-looking statements set forth herein speak only as of the date hereof. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 10.1 | April 21, 2020 Mutual Confidentiality Agreement with UMN Pharma Inc., National Institute of Infectious Diseases, and Shionogi & Co., Ltd. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AIM IMMUNOTECH INC. | ||
| April 27, 2020 | By: | /s/ Thomas K. Equels |
| Thomas K. Equels, CEO | ||
Exhibit 10.1
Mutual Confidentiality Agreement
This Mutual Confidentiality Agreement (Agreement) is made as of 21st April 2020 (“Effective Date”) between AIM ImmunoTech with its address at 2117 SW Hwy 484 Ocala Fl 34473 (“AIM”), and UMN Pharma Inc with its address at Nisso17 Bldg. 8F, 2-14-30, Shin-Yokohama, Kohoku-ku, Yokohama, Kanagawa 222-0033, Japan (“UMN”) and National Institute of Infectious Diseases with its address Toyama 1-23-1, Shinjuku-ku Tokyo 162-8640, Japan (“NIID”), and Shionogi & Co., Ltd, with its address at 1-8, Doshomachi 3-chome Choku-ku, Osaka 541-0045 Japan (“SHIONOGI”) (each a Party and together the Parties). The terms Recipients and Discloser refer to either Party, or the Parties, as the case may be.
RECITALS
WHEREAS, all Parties (“Recipient”) will have access to and be provided certain confidential and proprietary information of the other Parties (“Discloser”) for the purpose of evaluation and discussion for certain business relationship concerning the COVID-19 vaccine among the Parties (“Purpose”); and
WHEREAS, it is the desire of all Parties hereto that the confidentiality of all Discloser’s confidential information provided to Recipients pursuant to this Agreement be maintained.
NOW, THEREFORE, in consideration of the mutual covenants, conditions and promises herein contained, and other good and valuable consideration the sufficiency of which is hereby acknowledged, the Parties hereto agree as follows:
Definition of Confidential Information.
The term “Confidential Information” shall be defined as all oral and written information (irrespective of the means of the writing, e.g., hardcopy, fax, electronic writing, etc.) disclosed by Discloser or any employee, director, shareholder, agent, representative or consultant of Discloser to Recipient relating to the following:
a. Trade secrets, business, technical, financial and other confidential information pertaining to Discloser which is not generally available to the public, including without limitation, information concerning the customers, suppliers, contacts, and employees of Discloser; terms and conditions of Discloser’s agreements and arrangements with its customers, employees, suppliers and others; customer and supplier list, information concerning Discloser’s manufacturing processes and methods, inventory pricing, sales volumes and profits, procedures, marketing strategies, know-how, systems, developments and suggestions; data, drawings, plans, documents and specifications; and all other information about Discloser’s operations and business (as presently conducted and as proposed to be conducted); and
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b. Any and all information, agreements and documents in any form whatsoever regarding the capitalization, organization or ownership of Discloser; and
c. Any information generated or produced from Confidential Information given by Discloser to Recipient; provided however; it is expressly understood and agreed that Confidential Information shall not include any information which at the time of disclosure to Recipient is in the public domain, or information which, after disclosure to Recipient, becomes part of the public domain by publication or otherwise without breach of this Agreement by Recipient, or information which Recipient obtained from third parties, provided such information was not wrongly obtained by such third parties, or information which is independently developed by Recipient without reference to, or use of, Confidential Information.
Products currently owned by AIM include Ampligen and Alferon.
Recipient agrees to maintain in confidence all Confidential Information disclosed by Discloser and to never divulge or disseminate said Confidential Information, in whole or in part, to any third party, and to never make use of said Confidential Information other than for the Purpose without the prior written consent of Discloser.
In the event that Recipient has prepared or created, or does prepare or create, any document, memorandum, or other writing or determination relative to, resulting from, or in any way utilizing, in whole or in part, any of the Confidential Information, such document, research, or other writing or determination created or prepared by or for Recipient shall also constitute Confidential Information and such information shall be governed by the provisions of this Agreement.
In the event that any Confidential Information or any other information as described herein are required to be disclosed by any federal, state or local governmental body or agency, having the legal authority to require such disclosure by Recipient, such disclosure shall be in a manner which maintains confidentiality to the greatest extent permitted by law.
The Confidential Information shall remain or become the property of Discloser at all times. No rights or licenses, expressed or implied, are hereby granted to Recipient under any patents, copyrights or trade secrets of Discloser as a result of or related to this Agreement.
Upon request by Discloser, Recipient shall forthwith return to such Discloser all Confidential Information received by Recipient.
In the event Recipient violates or breaches this Agreement, Discloser shall be entitled to all damages proximately caused thereby. Further, Recipient acknowledges and agrees that monetary damages are unlikely to be an adequate remedy therefore, and without waiving any right to monetary damages, it is expressly agreed that Discloser is authorized and entitled to obtain temporary and permanent injunctive relief from any court of competent jurisdiction to restrain any breach of this Agreement, and any and all actions of Recipient relative to the Confidential Information. Any and all rights and remedies shall be cumulative and in addition to any other rights or remedies to which Discloser may be entitled.
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In the event of any action at law or equity, including arbitration to enforce or interpret any provision of this Agreement, the prevailing Party shall be entitled to costs incurred including reasonable fees for expert witnesses and reasonable attorney’s fees.
The Parties acknowledge that AIM is a public company and that any agreements including this Agreement that are reached between the Parties and AIM will be considered material and as such AIM will be filing reports in AIMs 8K, 10K and 10Qs that address AIM contractual relationships. This is an ongoing obligation that is required in order for AIM to adhere to SEC regulations.
This Agreement constitutes the entire understanding of the Parties with regard to the subject matter hereof and may not be amended, modified, supplemented or rescinded, except by a written instrument executed by all Parties hereto.
This Agreement shall be governed by and construed in accordance with the laws of the State of New York, United States of America.
If it shall subsequently be determined by a court of competent jurisdiction, that any portion of this Agreement is void, voidable or unenforceable, (including, but not limited to, any time or geographical limitation) it shall not necessarily affect the validity of the remaining provisions of this Agreement. Any such determination and its effect on this Agreement shall be to reform this Agreement so as to allow the terms and provisions of this Agreement to apply to the maximum permitted by applicable law, and this Agreement shall continue in full force and effect with regard to all other provisions.
This Agreement may be executed as one or more counterparts, each of which will be deemed an original agreement, but all of which will be considered one instrument and will become a binding agreement when one or more counterparts have been signed by all Parties. A signed facsimile of this document or an electronically transmitted signature of the original signed document shall have the same legal force and effect as an original of such signature and shall be treated as an original document for evidentiary purposes.
Recipient hereby agrees to indemnify, defend and hold Discloser harmless from any and all liabilities, expenses, causes of action, claims and liabilities arising out of or resulting, to any degree, from the unauthorized disclosure of Confidential Information of Discloser.
The obligations set forth in this Agreement shall continue for a period of five years following disclosure of such Confidential Information to Recipient.
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IN WITNESS WHEREOF, the Parties to this Agreement have duly executed it on the date set opposite their respective executions.
AIM ImmunoTech Inc
2117 SW Highway 484
Ocala FL 34473
| By: | /s/ Thomas K Equels | Date: | 4/21//2020 | |
| Thomas K Equels | ||||
| Title: | Chief Executive Officer |
UMN Pharma, Inc.
4-2-3, Gosyonoyumoto, Akita
Akita 010-1415
Japan
| By: | /s/ Fumihisa Nakata | Date: | 4/22//2020 | |
| Fumihisa Nakata | ||||
| Title: | Chief Executive Officer |
NATIONAL INSTITUTE OF INFECTIOUS DISEASES GAKUEN4-7-1,
Musashimurayama-shi,
Tokyo 208-0771,
Japan
| By: | /s/ Hideki Hasegawa | Date: | 4/22//2020 | |
| Hideki Hasegawa | ||||
| Title: | Director | |||
| Influenza Virus Research Center |
SHIONOGI & CO., LTD.
1-8, DOSHOMACHI 3-CHOME, CHUO-KU
OSAKA 541-0045,
JAPAN
| By: | /s/ Ryuichi Kiyama | Date: | 4/23//2020 | |
| Ryuichi Kiyama, Ph.D. | ||||
| Title: | Senior Executive Officer | |||
| Senior Vice President | ||||
| Pharmaceutical Research Division |
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