Document:

EXHIBIT
10.77

 

EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND

(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.

 

MATERIAL
TRANSFER AND RESEARCH AGREEMENT

 

This
Agreement is made as of November 29, 2020 (“Effective Date”) by and between AIM IMMUNOTECH INC. (“AIM”),
a corporation incorporated under the laws of Delaware, having an Offices at 2117 SW Hwy 484 Ocala Fl 34473 as the supplier of
the experimental drug Ampligen® and Ronald Brus, individually and on behalf of Leyden Laboratories, B.V. (“Leyden
Labs”) having an office at Keizersgracht 290A, 1016 EW Amsterdam, The Netherlands, (together referred to as “Companies”).
AIM and Leyden Labs shall be referred to individually as a “Party” and together as the “Parties.”

 

WHEREAS,
the Leyden Labs wishes to receive Confidential Information (as defined below) pertaining to AIM’s inventions and know-how
and also receive samples of AIM’s drug Ampligen®, solely for purposes of conducting studies described in
Exhibits A and B (“Research Projects”). It is the shared goal of the Parties to translate what is learned into clinical
research projects involving patients. This, it is understood, would require a separate license agreement, and

 

WHEREAS,
AIM is willing to provide Ampligen® to Leyden Labs solely for purposes of conducting Research Projects on the
following terms and conditions, and

 

WHEREAS,
the Parties agree that the commitments under this Agreement are not exclusive and that any Party may enter into similar agreements
with third parties.

 

WHEREAS,
AIM is providing Rintatolimod, also known as Ampligen® (“Study Drug”) and information to Leyden Labs
to perform the two experiments attached as Exhibits A and B (Research Projects).

 

WHEREAS,
this study is specific to a broad spectrum anti-viral prophylaxis principally intranasally and not as a part of any vaccine
program.

 

NOW
THEREFORE, in consideration of the premises and the mutual agreements and undertakings herein set forth, Leyden Labs and AIM hereby
agree as follows:

 

1.
DEFINITIONS. Whenever used in this Agreement, the following terms will have the following meanings:

 

1.1
“Confidential Information” means any confidential or proprietary information, knowledge, intellectual property including
but not limited to trade secrets and unpublished patent applications, pre-clinical and clinical information or data, technical
and/or non-technical material or property, relating to RNA pharmaceutical products and technologies, including but not limited
to double-stranded RNA compounds and in particular the double-stranded RNA compound trademarked Ampligen® provided
under this Agreement. A party disclosing Confidential Information shall be a “disclosing party” and a party receiving
same shall be a “receiving party.” The Confidential Information disclosed or provided by the disclosing party under
this Agreement is additionally governed by the Mutual Confidentiality Agreement between the Parties, dated as of October 23, 2020
(“Confidentiality Agreement”) which is incorporated by reference herein. Confidential Information also includes Trade
Secret. Trade Secret means any information, including a formula, pattern, compilation, program, device, method, technique, or
process that (i) derives independent economic value, actual or potential, from not being generally known to, and not being readily
ascertainable by proper means by, other persons who can derive economic value from its disclosure or use and (ii) is the subject
of efforts that are reasonable under the circumstances to maintain its secrecy.

 

    	1

    	 

    

 

1.2
“Material Events” means events, as AIM is a public company therefore, any agreements in AIM’s judgement, that
are required to be publicly disclosed under Federal and state securities laws, rules and regulations, including events that AIM
has customarily disclosed in the past, including this agreement, will be considered material and as such reports will be filed
in AIMs 8K, 10K and 10Qs that address AIM’s contractual relationships.

 

2.
PROVIDING OF MATERIAL FOR THE RESEARCH PROJECTS.

 

2.1
AIM shall provide to the Company such Ampligen® [***] as described in Exhibits A and B which as may
be reasonably requested by the Company from time to time for purposes of the Research Projects, and shall be used by Leyden Labs
solely for the purpose of conducting the Research Projects ( exhibits A&B).

 

2.2
The Parties shall provide to each other such Confidential Information as is necessary for purposes of the Research Projects. The
Parties shall exercise reasonable efforts to maintain the confidentiality of the Confidential Information.

 

2.3
Leyden Labs will utilize the Confidential Information exchanged and Ampligen provided solely for the purposes of conducting the
Research Projects and will not provide Ampligen to other entities outside of Leyden Labs without the express permission of AIM.

 

2.4
Leyden Labs will promptly and diligently pursue the Research Projects in a scientific manner, documenting in reproducible form
the work performed and results achieved in pursuing the Research Projects and disclose updates on the Research Projects to AIM
as described in Article 5 herein.

 

2.5
Due to research regulations Ampligen will be shipped as frozen Aliquots directly to Leyden Labs with appropriate instructions
for storage and use.

 

3.
INTELLECTUAL PROPERTY.

 

3.1
Ownership of and title to all trademarks, patents and other intellectual property rights in all inventions, discoveries, and other
intellectual property (all herein “Intellectual Property”) which are made, conceived, reduced to practice, generated
by or arising out of the Research Projects under this Agreement shall follow inventorship under U.S. patent and trademark law.
Inventions made solely by Leyden Labs shall be owned solely by the Leyden Labs. Inventions made by the Parties shall be owned
by the Parties jointly.

 

3.2
Nothing in the Agreement should be construed as a license or authorization from AIM for any use of any of AIM’s trademarks
including the trademark Ampligen®.

 

    	2

    	 

    

 

3.3
Inventions made solely by AIM include, at least, all patents and patent applications including provisional patent applications,
whether published or unpublished, filed by AIM, assigned to AIM, or issued to AIM in the United States, Holland and worldwide.
These inventions made solely by AIM, including multiple patents and applications, and including patents and patent applications
comprising Ampligen®, and also including any composition comprising Ampligen® or a therapeutic double-stranded
RNA, are owned solely by AIM. Nothing in this Agreement should be construed as a license to any intellectual property, patents,
and patent applications owned solely by AIM. However, AIM is willing to negotiate a license to these intellectual property and
developments.

 

3.4
AIM currently has Ampligen and therapeutic double-stranded RNA, as a broad spectrum anti-viral prophylaxis, as part of provisional
patent applications and any rights to it for this purpose would have to part of a separate commercial agreement and it is understood
by Leyden that AIM has the priority associated with the existing provisional patents. Further, it is understood that AIM may have
“provisional rights” in existing patent applications, for example, after their publication.

 

4.
CONFIDENTIALITY.

 

4.1
Please see the attached Mutual Confidentiality Agreement signed and dated by all Parties which remains in full force and effect
and which is incorporated by reference in Section 1.1.

 

5.
DISCLOSURE 

 

5.1
Results of the Research Projects (“Results”) including efficacy and safety data are provided without warranty of any
type and Leyden Labs shall not be liable to AIM in any way for use of such Results. AIM is authorized to use updates of data as
they are made available to AIM, including data from pre-clinical studies which is needed for submission to the FDA, other regulatory
bodies and timely disclosure of Material Events to the public or where it is needed to comply with applicable laws and regulations.
The Parties shall not publish or present the Results without prior written consent of the other Party, which consent shall not
be unreasonably withheld.

 

5.2
Leyden Labs will provide AIM with a report every three (3) months and with a final written report within sixty (60) days after
the conclusion of Research Projects described in Exhibits A and B. If requested by AIM, Leyden Labs will confirm within a reasonable
period of time, but no later than thirty (30) days, any oral progress reports with follow-up summary written reports. The written
reports will include descriptions of the methods used and results obtained together with any other pertinent findings from the
Research Projects.

 

6.
INDEMNIFICATION

 

6.1
The Parties shall indemnify, defend and hold harmless the other Party, its directors, officers, employees against any third party
claims, including reasonable attorney’s fees for defending those claims (each, a “Claim”), to the extent a Claim
arises out of improper use, storage, or disposal of the drug(s), unless such Claim is solely due to the gross negligence or material
and willful misconduct of the indemnified Party.

 

    	3

    	 

    

 

7.
TERMINATION.

 

7.1
This Agreement shall terminate upon the earlier of (a) the completion of the Research Projects, (b) the written agreement signed
by authorized representatives of the Company, or (c) one (1) year from the Effective Date; provided that, the provisions of Articles
3, 4 and 6, and Section 8.5 and 8.6 shall survive the termination of this Agreement indefinitely.

 

8.
MISCELLANEOUS.

 

8.1
Notices. All notices required or permitted to be given under this Agreement will be given in writing and will be effective
when either personally delivered (including delivery by Federal Express or other internationally recognized courier), or when
sent by facsimile, addressed as follows:

 

To
Leyden Laboratories, B.V.:

Dennis
de Vlaam

Keizersgracht
290 A

1016
EW Amsterdam

The
Netherlands

+31-652-643-650

Dennis.devlaam@Leydenlabs.com

 

To
AIM ImmunoTech Inc.:

Thomas
K. Equels

AIM
ImmunoTech Inc.

2117
SW Highway 484

Ocala,
Florida 34473

 

Or
such other address as each Party may hereinafter specify by written notice to the other under this Section 8.1. Such notices and
communications will be deemed effective on the date of personal delivery or upon confirmed answer back by facsimile.

 

8.2
Entire Agreement; Amendment and Waivers. This Agreement, including the Confidentiality Agreement incorporated in this Agreement,
is the entire agreement between Leyden Labs and AIM with respect to the specific subject matter hereof. This Agreement may not
be modified, amended or terminated, nor may any term hereof be waived, except by an instrument in writing, signed by authorized
representatives of both Leyden Labs and AIM.

 

8.3
Severability; Enforcement. If any provision of this Agreement, or the application thereof to any person, place, or circumstance,
is held by a court of competent jurisdiction to be invalid, unenforceable, or void, as written, in whole or in part, such provision
will be deemed to be amended to the extent necessary to be enforceable and applied by such court in the broadest possible manner,
consistent with enforceability, and the remainder of this Agreement and such provisions as applied to other persons, places, and
circumstances will remain in full force and effect.

 

8.4
Assignment; Binding Effect. This Agreement may not be assigned, nor may any of the rights or obligations be delegated,
without the prior approval of both Parties.

 

    	4

    	 

    

 

8.5
Remedies. The Parties agree that in the event of any breach or threatened breach of any of the covenants herein, the damage
or imminent damage to the value and the goodwill of a Party may be irreparable and extremely difficult to estimate, making any
remedy extremely difficult to estimate, and/or making any remedy at law or in damages inadequate. Accordingly, the Parties agree
that they will be entitled to seek injunctive relief against the other Party in the event of any breach of any such terms of this
Agreement, in addition to any other relief (including damages) available under this Agreement or under law.

 

8.6
Governing Law. The validity, interpretation, enforceability, and performance of this Agreement will be governed by and
construed in accordance with the laws of the State of Florida, U.S.A. without regard to the application of conflict laws.

 

8.7
Force Majeure. No Party will be liable to the other for any failure or delay in the performance of its obligations to the
extent such failure or delay is caused by fire, flood, earthquakes, other elements of nature, acts of war, terrorism, riots, civil
disorders, rebellions or revolutions, disease, epidemics, quarantines, pandemics, acts of government, a declared state of emergency,
delays in visas, changes in laws and governmental policies, or other conditions beyond its reasonable control following execution
of this Agreement. If the performance by either Party of any of its obligations under this Agreement (including making a payment)
is prevented by any such circumstances, then such Party shall communicate the situation to the other as soon as possible, and
the Parties shall endeavor to limit the impact to the Projects. The Parties agree to mitigate risks to the Research Projects and
personnel, and to amend Research Projects period of performance and milestones if possible.

 

IN
WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.

 

	AIM
    ImmunoTech, Inc.	 	 
	 	 	 	 
	By:	/s/
    Peter W. Rodino	 	Date:
    November 27, 2020
	Name: 	Peter.
    W. Rodino	 	 
	Title:	General
    Counsel	 	 
	 	 	 	 
	Leyden
    Labs & Co., Ltd.	 	 
	 	 	 	 
	By:	/s/
    Ronald Brus	 	Date:
    26 November 2020
	Name:	Ronald
    Brus	 	 
	Title:	jointly
    authorized director	 	 
	 	 	 	 
	By:	/s/
    Dinko Valerio	 	Date: 23
    November 2020
	Name:	Dinko
    Valerio	 	 
	Title:	jointly
    authorized director	 	 

 

	Ronald
    Brus	 	 
	 	 	 	 
	By:	/s/Ronald
    Brus	 	Date:
    26 November 2020 
	Name: 	Ronald
    Brus	 	 
	Title:	 	 	 

 

    	5

    	 

    

 

Exhibit
A – Research Projects

 

Assessment
of protective potential of intranasal administration of Ampligen in SARS-CoV-2 Syrian hamster challenge model.

 

Following
intranasal infection of hamsters SARS-CoV-2 virus replicates efficiently in the lungs, causing severe pathological lung lesions
sharing characteristics with SARS-CoV-2−infected human lung. We will perform a dose-finding study with Ampligen in Syrian
hamsters. (Dose and Schedule to be discussed and agreed upon with AIM)

 

Hamsters
[***]

 

    	6

    	 

    

 

Exhibit
B – Research Project

 

Research
outline for Ampligen dose finding studies in mouse influenza challenge model. 

 

Assessment
of protective potential of intranasal administration of Ampligen in lethal influenza mouse challenge model. 

 

Study
Outline:

 

[***]

 

    	7

    	 

    

 

CONFIDENTIALITY
AGREEMENT

 

This
Mutual Confidentiality Agreement (“Agreement”) is entered into as of October 23, 2020 (the “Effective Date”)
between Leyden Laboratories B.V., located at Keizersgracht 290 A. 1016 EW Amsterdam, the Netherlands (“Leyden Labs”)
and AIM ImmunoTech Inc located at 2117 SW Highway 484, Ocala FL 34473 (“AIM”). Leyden Labs and AIM shall be hereinafter
sometimes referred to individually as a “Party” and collectively as the “Parties.”

 

RECITALS

 

WHEREAS,
both Parties are in possession of certain information, more specifically related to vaccine technologies, adjuvant technologies
and the combination of these technologies that each Party believes might be of interest to the other and each Party desires to
disclose such information to explore possible opportunities to exploit this information in a mutually beneficial manner (the “Purpose
of this Agreement”).

 

WHEREAS,
in accomplishing the Purpose of this Agreement Leyden and AIM may exchange information which (1) defined below and (2) is related
to the Purpose of this Agreement, (hereinafter “Confidential Information”); and

 

WHEREAS,
Leyden Labs and AIM wish to set forth their understanding as to how Confidential Information will be treated in achieving the
Purpose of this Agreement.

 

NOW,
THEREFORE, in consideration of the premises set forth above and the mutual covenants hereinafter set forth and other good and
valuable consideration the sufficiency of which is hereby acknowledged, Leyden Labs and AIM, intending to be legally hereby agree
as follows:

 

AGREEMENT

 

	1.	Disclosure.
                                         Leyden Labs and AIM may each disclose to the other certain Confidential Information in
                                         accomplishing the Purpose of this Agreement. All Confidential Information shall be deemed
                                         proprietary information.
	 	 
	2.	Confidential
                                         Information. The term Confidential Information means all technical data, information,
                                         reports, presentation materials, interpretations, forecasts and other records to the
                                         extent they contain information which is not available to the general public and which
                                         either party provides to the other under this Agreement (including, without limitation,
                                         descriptions, discoveries, know-how, trade secrets, inventions, patent disclosures and
                                         applications, drawings, tests, results, recombinant DNA vectors, genes, cell lines, experimental
                                         designs and protocols, biological materials, application devices, samples, design prototypes,
                                         and related information). To the extent practicable, confidential information may be
                                         disclosed, orally or visually, in documentary, tangible, intangible, or electronic form.
                                         Confidential Information also shall include any opinions, judgments or recommendations
                                         developed or information derived from Confidential Information.

 

    	8

    	 

    

 

	3.	Exceptions.
                                         The obligations regarding Confidential Information under this Agreement shall not apply
                                         to any information which:

 

		(a)	Is
                                         or becomes available to the general public without fault of the party which received
                                         such information;
	 	 	 
		(b)	Was
                                         previously known to the party receiving the information through no fault of the Party
                                         to the Agreement disclosing the information, as evidenced by tangible, or electronic
                                         records or other competent evidence and the receiving party is not subject to a Confidentiality
                                         Agreement with the nondisclosing Party of this Agreement;
	 	 	 
		(c)	Subsequently
                                         is rightfully obtained from a third party who lawfully possessed the information and
                                         who had the right to make such disclosures;
	 	 	 
		(d)	Is
                                         independently developed by the Party receiving the information without the assistance
                                         of Confidential Information as evidenced by tangible, or electronic records or other
                                         competent evidence.
	 	 	 
	 	The
                                         disclosing party’s Confidential Information may be disclosed by the receiving party
                                         as required to be disclosed to the public directly or be accessed by a freedom of information
                                         request as a result of an order of a court of law or other governmental body, provided
                                         the receiving party gives the disclosing party prompt written notice of such requirement
                                         prior to such disclosure and assistance in obtaining an order protecting the information
                                         from public disclosure.

 

	4.	Use
                                         and Obligations. Confidential Information shall be used exclusively for accomplishing
                                         the Purpose of this Agreement. Confidential Information shall not become the property
                                         of the Party receiving the Confidential Information, shall be kept confidential and shall
                                         be protected from disclosure by that Party exercising at least the same degree of care
                                         as it uses to protect its own proprietary information. Furthermore, no right is granted
                                         to make, sue, or sell materials described in the Confidential Information. Any employee,
                                         consultant or other agent to whom a recipient Party discloses Confidential Information
                                         must be subject to confidentiality obligations covering the Confidential Information
                                         to the same or greater extent as the recipient Party is obligated by this Agreement.
                                         Each Party will keep a record of the location of the Confidential Information.
	 	 
	5.	Procedure
                                         for Required Disclosure. In the event that Leyden Labs or AIM is requested or
                                         required to disclose (i) any Confidential Information or (ii) any opinions, judgments
                                         or recommendations developed from the Confidential Information, the Party holding the
                                         Confidential Information will, prior to disclosing such Confidential Information, provide
                                         the other Party with prompt notice of such requests(s) or requirements(s) so that the
                                         other Party may seek appropriate legal protection or waive compliance with the provisions
                                         of this Agreement. If no legal protection or waiver is obtained and the Party holding
                                         the Confidential Information is, in the opinion of its counsel, compelled by law to disclose
                                         certain Confidential Information, it may disclose that Confidential Information. The
                                         Party holding the Confidential Information will not oppose action by and will cooperate
                                         with the Party to obtain legal protection or other reliable assurance that confidential
                                         treatment will be accorded the Confidential Information.
	 	 
	6.	Return
                                         of Confidential Information. At the request of either Party, the other Party
                                         and its representatives shall (a) within fourteen (14) days return or destroy all physical
                                         representations of the Confidential Information; and (b) not retain any copies, extracts
                                         or reproductions in whole or in part of such written Confidential Information, except
                                         for one copy retained for legal archival purposes. The obligation to destroy or return
                                         does not apply to Confidential Information that is stored on back-up tapes and similar
                                         media that are not readily accessible to the receiving Party.

 

    	9

    	 

    

 

	7.	Accuracy
                                         and Completeness. Neither the Party providing the Confidential Information nor
                                         any of its representatives make any representation, express or implied, as to the accuracy
                                         or completeness of the Confidential Information. The Party providing the Confidential
                                         Information and its representatives shall not have any liability relating to or resulting
                                         from the use of the Confidential Information or any errors therein or omissions therefrom.
	 	 
	8.	Confidentiality
                                         of the Exchange. Neither Leyden Labs nor AIM shall disclose that Confidential
                                         Information has been made available, that discussions or negotiations are taking place
                                         concerning a possible transaction involving the Parties or any of the terms, conditions
                                         or other facts with respect thereto.
	 	 
	9.	No
                                         Rights or License Granted. No disclosure to either Party hereunder shall be construed
                                         to grant to the receiving Party any rights whatever to or license to the providing Parties
                                         Confidential Information, patents, inventions and proprietary information, or any innovation,
                                         invention, technological development, product, or materials or information that is the
                                         result of either Parties use of such Confidential Information, in all events except as
                                         otherwise provided in a separate express written agreement between and among the Parties
                                         hereto.
	 	 
	10.	No
                                         Formal Business Obligations. Each Party agrees that unless and until a definitive
                                         agreement between the parties with respect to any business relationship or transaction
                                         has been executed and delivered, neither Party shall be under any legal obligation to
                                         the other Party of any kind whatsoever with respect to any business arrangement or transaction
                                         by virtue of this Agreement or any written or oral expression with respect to such business
                                         arrangement or transaction by any of its directors, officers, employees, agents or any
                                         other representatives or its advisors, except for the matters specifically agreed to
                                         in this Agreement. Each Party further agrees that neither Party shall have any obligation
                                         to authorize or pursue with the other or any other Party any business arrangement or
                                         transaction. Each Party understands that the other Party has, as of the date hereof,
                                         not authorized any such arrangement or transaction.
	 	 
	11.	Term;
                                         Termination. This Agreement will be effective as of the Effective Date and continue
                                         for a term of five (5) years. This agreement may be terminated by either Leyden Labs
                                         or AIM at any time upon thirty (30) days written notice to the other. Upon termination
                                         of this Agreement, all Confidential Information and any copies shall be returned or destroyed
                                         pursuant to Paragraph 6. Notwithstanding termination of this Agreement, the obligations
                                         of confidentiality in the Agreement will remain in effect for a period of five (5) years
                                         from the date any Confidential Information is received by either Leyden Labs or AIM.
	 	 
	12.	Modification
                                         and Assignment. This Agreement may only be modified by written agreement signed
                                         by both Leyden Labs and AIM and shall be binding upon both Leyden Labs and AIM, their
                                         representatives, successors and assigns. This Agreement shall not be assignable by either
                                         Leyden Labs or AIM without the prior written consent of the other provided, however,
                                         either Party may assign this Agreement in conjunction with the sale of all or substantially
                                         all of its assets to a third-party acquirer.
	 	 
	13.	Applicable
                                         Laws. This Agreement shall be interpreted in accordance with the laws of the
                                         State of Florida.
	 	 
	14.	Reservation
                                         of Rights. Nothing in this Agreement shall be construed to prevent, during the
                                         term hereof or thereafter, either Leyden Labs or AIM from (1) using in any manner, or
                                         disclosing in any way to one or more third parties, any and all of its own Confidential
                                         Information or (2) entering into negotiations or agreements with third parties concerning
                                         its own Confidential Information.

 

    	10

    	 

    

 

	15.	Access
                                         to Evaluation. Either Leyden Labs or AIM shall have a right to obtain a copy
                                         of opinions, judgments or recommendations developed from the Confidential Information
                                         or from information derived therefrom, the results of any research and testing performed
                                         in the course of evaluating the Confidential Information pursuant to this Agreement.
                                         All information obtained pursuant to this Paragraph 15 shall be subject to the confidentiality
                                         provisions of this Agreement during the term of this Agreement and for a full year period
                                         following termination thereof.
	 	 
	16.	Breach
                                         of Agreement. In the event of any breach of this agreement by the receiving Party,
                                         the non-breaching Party, in addition to any other remedy to which it may be entitled
                                         in law or equity, shall be entitled to an injunction or injunctions to prevent breaches
                                         of this agreement. The breaching party agrees to waive and use its best efforts to cause
                                         the other recipients to waive, any requirement for the securing or posting of any bond
                                         in connection with such remedy. The breaching party also agrees to reimburse all costs
                                         and expenses, including attorney’s fees, incurred by the other party in successfully
                                         enforcing this agreement in the event a court of competent jurisdiction determines that
                                         the breaching party has willingly breached this agreement.
	 	 
	 	No
                                         Warranty. All Confidential Information is provided “as is” without warranty
                                         of any kind, whether express or implied herein. The disclosing Party does not represent
                                         or warrant the accuracy or completeness of the Confidential Information. Accordingly,
                                         the entire risk of using the Confidential Information remains with the receiving Party.
	 	 
	 	No
                                         failure or delay by either Leyden Labs or AIM in exercising any right, power or privilege
                                         hereunder shall operate as a waiver thereof, nor shall any single or partial exercise
                                         thereof or the exercise of any other right, power or privilege hereunder.

 

IN
WITNESS WHEREOF, Leyden Labs and AIM have executed this Agreement on this the 23rd day of October 2020.

 

	For
    Leyden Labs:	 	For
    AIM ImmunoTech Inc.:
	 	 	 	 	 
	/s/
    Dennis de Vlaam	 	/s/
    Peter W. Rodino
	Name: 	D.
    de Vlaam	 	Name: 
    	Peter
    W. Rodino, III
	Its:	Head
    of Operations	 	Its:
    	General
    Counsel

 

    	11Exhibit
10.78

 

 

EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND

(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.

 

Amendment
01 to Project AIM02

Statement
of Work and Budget for

 

Original
Amarex Project No.:

AIM02_Phase
1 & 2

 

Prepared
for:

AIM
ImmunoTech Inc.

2117
SW Highway 484

Ocala,
FL 34473

 

Prepared
by:

Amarex
Clinical Research, LLC

20201
Century Boulevard

Germantown,
MD 20874

Phone:
(301) 528-7000

Fax:
(301) 528-2300

 

Amendment
Date: December 30, 2020

 

 

This Amendment 1 to the Amarex Project AIM02 is prepared for the
exclusive use of AIM, for the work indicated herein. It is proprietary and not to
be copied or distributed outside of AIM.

 

 

    	Amarex Confidential and Proprietary
	
	Amendment 01 to AIM02 Contract	12/30/20

	Additional Services	Page 1

     

    

 

1.
Terms and Conditions

 

 

Made
this 30th day of December, 2020 (the “Effective Date”) to the Project Agreement made on the 6th day of
August, 2020 (the “Agreement) by and between:

 

AIM
Immunotech Inc., a corporation with its principal place of business at 2117 SW Highway 484, Ocala, FL 34473 (hereinafter “AIM”),
AND

 

Amarex
Clinical Research, LLC, a for-profit Maryland limited liability company with its principal place of business at 20201 Century
Boulevard, Germantown, Maryland 20874. (hereinafter “Amarex”).

 

WHEREAS
AIM has requested and Amarex has agreed to provide certain Services in addition to those in the Agreement relating to additional
services.

 

NOW
THEREFORE, the parties hereby agree to amend the Agreement as follows:

 

		1.	Amarex
                                         agrees to provide the Services as listed in Section 2, Project Statement of Work.
	 	 	 
		2.	AIM
                                         agrees to pay Amarex the costs noted in Section 4, Amendment Budget.
	 	 	 
		3.	AIM
                                         will pay the costs associated with the Amendment according to Section 5, Payment Schedule.

 

This
Amendment may be signed in any number of counterparts, which, when taken together, will constitute one and the same Amendment.

 

IN
WITNESS WHEREOF, the authorized representatives of the parties have duly executed this agreement as of the Effective Date.

 

FOR
AND BEHALF OF:

 

	For and on behalf of AIM Immunotech Inc.:	 	For
    and on behalf of Amarex Clinical Research, LLC:
	 	 	 
	Print
    Name: 	Peter
    W. Rodino	 	Print
    Name: 	Kazem
    Kazempour
	 	 	 	 	 
	Signature:
    	/s/
    Peter W. Rodino	 	Signature:
    	/s
    /Kazem Kazempour
	 	 	 	 	 
	Title:
    	COO	 	Title:
    	President
    and CEO (Member)
	 	 	 	 	 
	Date:	1/5/2021	 	 Date:	1/6/2021

 

    	Amarex Confidential and Proprietary
	
	Amendment 01 to AIM02 Contract	12/30/20

	Additional Services	Page 2

     

    

 

2.
Project Statement of Work

 

 

Amarex
will support AIM in clinical trial work, to include:

 

	 	●	Monitoring
    of the Phase I Unit in the Netherlands by a local Dutch monitor.
	 	 	 
	 	●	Setup
    and maintenance of a shadow TMF, and investigator site files can be provided if the Phase I Unit does not do this itself.
    Training of a backup CRA can be conducted, if needed.

 

Assumptions

 

	Activity
    / resource	 	Unit
	Patients,
    territories and sites	 	 
	Enrolled
    patients 	 	40
	Sites
    	 	1
	Countries
    	 	1
    (NL)
	CRAs	 	1

        (backup
        CRA training billed if required)

	Study
    duration (months)	 	 
	Set
    up duration	 	1.0
	Conduct
    	 	5
	Closure
    duration	 	1.0
	Meetings
    and visits	 	 
	KO
    TC	 	1
	Investigator
    meetings 	 	NA
    
	Sponsor/CRO
    Study Team Teleconferences	 	9x
        1hr TCs in total

        Fortnightly
        during set up

        Monthly
        during Conduct

        Fortnightly
        during closure

	Site
    visits	 	 
	PSVs	 	0
	SIVs	 	1
	MVs
    - Conduct 	 	6
    (1x 1 day visit and 5x 2 day visits)
	COVs	 	1

 

3.
Timelines

 

 

Amarex
will begin working upon approval of this Amendment.

 

    	Amarex Confidential and Proprietary
	
	Amendment 01 to AIM02 Contract	12/30/20

	Additional Services	Page 3

     

    

 

4.
Amendment Budget

 

 

Services

 

	CLINICAL SITE SERVICES	 
	Bid ID	 	Service	 	Unit Description	 	 	Unit Cost $	 	 	No. 
 Units
	 	 	Total 
 Cost $ 
	 	 	 	Category 
 Total $ 
	 
	 	 	Study start-up (1 months)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1	 	Study familiarisation	 	Once	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	 	 
	2	 	Study KO meeting (TC)	 	Once	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	 	 
	3	 	Preparation of PM Plans	 	Plans	 	 	$ [***]	 	 	4	 	 	$ [***]	 	 	 	 	 
	4	 	Site initiation	 	Sites	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	 	 
	5	 	In-house SCRA activities - set up including site communication	 	Site / months	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	 	 
	6	 	Sponsor TCs - set up	 	Alternate Weeks	 	 	$ [***]	 	 	2	 	 	$ [***]	 	 	 	$ [***]	 
	 	 	Conduct (5 months)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	7	 	Monitoring Visits	 	IMV	 	 	$ [***]	 	 	6	 	 	$ [***]	 	 	 	 	 
	8	 	In-house SCRA activities - conduct 
including site communication	 	cohorts	 	 	$ [***]	 	 	4	 	 	$ [***]	 	 	 	 	 
	9	 	Sponsor TCs - Conduct	 	monthly	 	 	$ [***]	 	 	5	 	 	$ [***]	 	 	 	$ [***]	 
	 	 	Study closure (1 months)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	10	 	Close-Out	 	COVs	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	 	 
	11	 	In-house SCRA activities - closure 
including site communication	 	Site / months	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	 	 
	12	 	Sponsor TCs - closure	 	Alternate Weeks	 	 	$ [***]	 	 	2	 	 	$ [***]	 	 	 	$ [***]	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	TOTAL	 	 	 	 	 	 	 	 	 	 	$ [***]	 	 	 	 	 

 

Optional
Services

 

	OPTIONAL SERVICES	 
	Bid ID	 	Service	 	Unit Description	 	Unit Cost $	 	 	No. 
 Units
	 	Total 
 Cost $ 
	 	 	Category 
 Total $ 
	 
	 	 	Study start-up (1 months)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	13	 	Backup CRA familiarization and training	 	per CRA	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	 	 
	14	 	Set up shadow TMF	 	Sites	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	 	 
	15	 	Set up ISFs	 	Sites	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	$ [***]	 
	 	 	Conduct (5 months)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	16	 	Maintenance of TMF - Conduct	 	Site / months	 	 	$ [***]	 	 	5	 	 	$ [***]	 	 	 	$ [***]	 
	 	 	Study closure (1 months)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	17	 	Return of TMF to sponsor	 	Sites	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	$ [***]	 

 

    	Amarex Confidential and Proprietary
	
	Amendment 01 to AIM02 Contract	12/30/20

	Additional Services	Page 4

     

    

 

Estimated
Pass-Through

 

	Estimated Pass-Through Costs	 
	Bid ID	 	Service	 	Unit Description	 	 	Unit Cost $ 	 	 	No. 
 Units
	 	 	Total 
 Cost $ 
	 	 	 	Category 
 Total $ 
	 
	1	 	Printing/Shipping	 	site months	 	 	$ [***]	 	 	7	 	 	$ [***]	 	 	 	 	 
	2	 	Communications	 	TCs	 	 	$ [***]	 	 	9	 	 	$ [***]	 	 	 	$ [***]	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	ESTIMATED TOTAL	 	 	 	 	 	 	 	 	 	 	$ [***]	 	 	 	 	 

 

5.
Payment Schedule

 

 

	Payment Description	 	Percentage Due	 	Amount
	Monthly Unit-Based Billing	 	TBD	 	TBD

 

AIM
will be billed according to the same terms and provisions as outlined in the Agreement.

 

    	Amarex Confidential and Proprietary
	
	Amendment 01 to AIM02 Contract	12/30/20

	Additional Services	Page 5

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