Exhibit 10.1

 

17 March 2020

 

Ms. Noreen Griffin

President & Chief Executive Officer

Cytocom, Inc.

3001 Aloma Ave., Winter Park, FL 32792

 

SUBJECT: BINDING LETTER OF INTENT

 

Dear Ms. Noreen Griffin:

 

Immune Therapeutics Inc. (“IMUN”) and Cytocom, Inc. (“CYTO”) have been
discussing a possible collaboration between the two companies to create a
program to develop Lodonal™ (IRT-103) and IRT-101 as a therapeutic intervention
for COVID-19 infections and also as a potential prophylactic agent to attenuate
the spread of the disease. Both parties are interested in entering into a
definitive collaboration agreement (the “Agreement”) between IMUN and CYTO to
combat the COVID-19 pandemic.

 

In order to expedite the development and execution of the Agreement, we propose
signing of this Letter of Intent (“LOI”) we enter into an exclusive period of
negotiation for one hundred and twenty (120) days to complete the definitive
Agreement. Accordingly, on behalf of IMUN, I am pleased to provide you with this
binding LOI.

 

1. Collaboration. The goal of this collaboration is to leverage IMUN ’s
expertise in drug development, regulatory and clinical trials to assist CYTO in
bringing Lodonal™ and IRT-101 to market as a therapeutic intervention for
COVID-19 and also as a prophylactic agent to attenuate the spread of the
disease.

 

2. Consideration. For consideration for IMUN ’s assistance in their drug
development programs, CYTO agrees to the following:

 

2.1 Michael Handley will assume the role of Interim CEO of CYTO.

 

2.2 IMUN will collaborate with CYTO on the development of Lodonal (IRT-103) and
IRT-101 for the therapeutic intervention of COVID-19 in patients and also as a
prophylactic agent to attenuate the spread of the disease (in addition to other
potential indications as the parties will agree on from time-to-time).

 

2.3 IMUN will be responsible for filing New Drug Application for Lodonal and
IRT-101 with the FDA.

 

2.4 IMUN will be responsible Type C Meeting with the FDA on behalf of CYTO.

 

2.5 IMUN will be responsible for providing final briefing package and protocols
for COVID-19 prophylaxis and treatment.

 

2.6 IMUN will provide funding for COVID-19 treatment and prophylaxis under the
Agreement

 

2.7 IMUN will develop and file the IND for Lodonal and IRT101 for the
prophylaxis and treatment of COVID-19.

 

   

 

 

3. Collaboration Agreement. IMUN will draft the Collaboration Agreement (the
“Agreement”) among IMUN and CYTO, and the parties will continue to negotiate, in
good faith, the terms thereof.

 

4. Due Diligence. CYTO will continue to extend its full cooperation to IMUN and
its development team. IMUN, its management team, scientists and clinicians shall
to have full access to CYTO’s data, protocols and reports for Lodonal™ or
IRT-101 use.

 

5. Public Announcements. Subject to applicable law, neither party hereto shall
make any additional public announcement relating to this transaction until the
signing of the collaboration agreement, and any announcements made thereafter
will be mutually agreed upon and jointly made by the parties.

 

6. Filings and Applications. Each party shall continue to cooperate fully with
the other party in furnishing any necessary information required in connection
with (i) the preparation, distribution and filing with the Securities and
Exchange Commission (“SEC”), in each case, if necessary, of a proxy statement,
an information statement, and any other filing or document required by the SEC,
and (ii) the preparation, distribution and filing of any filings, applications
and notices which may be required by other federal, state and local governmental
or regulatory agencies or stock exchanges in any jurisdiction, including the
United States and Canada.

 

7. Brokers. Neither IMUN , CYTO, nor any of their officers, directors, employees
or stockholders has retained or used, and none of them will retain or use, the
services of any broker, finder or investment banker which would result in the
imposition of a fee or any other compensation of any kind to any third- parties
in connection with this LOI or the collaboration agreement.

 

8. Responsibility and Costs. Each party will be responsible for their own costs
and expenses associated with the transactions contemplated hereby, including,
but not limited to, legal fees and costs, and the costs associated with
obtaining shareholder, governmental and other third-party approvals. Also, CYTO
will be responsible the funding of the developmental work, including but not
limited to, clinical trials, GMP manufacturing and regulatory filings.

 

9. Exclusivity. In consideration of IMUN ’s undertaking the effort of , CYTO
agrees that for a period of one hundred and twenty (120) days after the date
hereof, it shall not consider, seek or solicit, negotiate with, or engage anyone
to seek, solicit, or negotiate on behalf of CYTO or its stockholders, or provide
or cause to be provided information to, any third party in connection with any
proposal or offer with respect to the acquisition of CYTO, or all or
substantially all of its assets.

 

10. Governing Law/Jurisdiction. This Letter of Intent shall be governed by, and
construed in accordance with, the laws of the State of Florida, without regard
to such State’s principles of conflicts of law. The parties’ consent to the
jurisdiction of the courts of the United States and Florida located in such
state for the resolution of any dispute relating to this LOI.

 

11. Confidentiality. IMUN and CYTO have strict respect for the significant value
of each other’s confidential information. IMUN and CYTO are parties to a
Confidential Nondisclosure Agreement dated 17 March 2020 (“CDA”). By the
execution hereof, IMUN and CYTO agree that the CDA are and remain in effect in
accordance with the respective terms, and they reaffirm their respective rights
and duties thereunder. If both parties enter into the Agreement, the Agreement
will supersede the CDA.

 

12. Third Parties. This Letter of Intent is intended for the sole and exclusive
benefit of the parties hereto and their respective successors and controlling
persons, and no other person, firm or corporation shall have any third-party
beneficiary or other rights hereunder.

 

13. Approval and Authority. The individuals signing this LOI on behalf of the
parties have all authority needed to execute this document on their respective
behalves.

 

   

 

 

14. Binding Provisions. Notwithstanding the non-binding nature of this LOI,
Sections 9 “Exclusivity” and 11 “Confidentiality” hereof are binding upon the
parties and shall be enforceable by them.

 

15. Next Steps. Negotiation Period will begin upon execution of this document.
IMUN will prepare a first draft of the Agreement. Following the signing of this
LOI, the Agreement will be negotiated (the Negotiation Period). The Negotiation
Period will begin at the signing of the LOI and will end when the Agreement is
fully signed. It is foreseen that the Negotiation Period will last for one
hundred and twenty (120) days, however it is noted that this period may be
longer than one hundred and twenty (120) days, depending on the efficiency of
both parties in the activities to be conducted during the Negotiation Period. If
the Parties haven't executed the Agreement by the end of the Negotiation Period,
the Parties may mutually agree to extend the Negotiation Period upon the payment
of appropriate consideration. Both parties agree to negotiate the Agreement in
good faith, as expeditiously as reasonable

 

This letter is intended to constitute an offer that is binding upon acceptance.
Except as specified above, neither party is under any obligation with respect to
the subject matter hereof until such time that both parties have executed the
Agreement and related agreements, if any, and all conditions set forth therein
have been satisfied.

 

If the foregoing represents your understanding of the terms of our preliminary
agreement, please sign this LOI on the below-designated line and return a copy
to the undersigned no later than 5:00 p.m. (Eastern time) on 18 March 2020.

 

CYTOCOM, INC. IMMUNE THERAPEUTICS, INC.      Signature of Authorized Officer
Signature of Authorized Officer      Noreen Griffin (CEO and President) Michael
K. Handley (CEO & President) Name of Authorized Officer (Title) Name of
Authorized Officer (Title)      Date Signed (day/month/year) Date Signed
(day/month/year)