Exhibit
10.1


 


AMENDMENT NO. 1 TO


MATERIAL TRANSFER AND RESERACH
AGREEMENT


 


This First Amendment to the
Material Transfer and Research Agreement (the “Agreement”) dated July 11, 2017,
by and between AIM ImmunoTech Inc. (“AIM”), formerly Hemispherx
Biopharma, Inc., and ROSWELL PARK CANCER INSTITUTE (“INSTITUTE”),
who are each a “Party” and together the “Parties”
to the Agreement, is entered into as of March 20, 2020 (the “Amendment
No. l Effective Date”).


 


RECITALS


 


WHEREAS, AIM and INSTITUTE
are Parties to the Agreement for the transfer of Ampligen (rintatolimod) from AIM to Institute ;


 


WHEREAS,
the Parties wish to further amend the Agreement to include an Exhibit listing the current Clinical Studies, as set
forth in the attached Exhibit A;


 


NOW, THEREFORE, the
Parties hereby agree as follows :


 


Definitions and References.
Except as set forth herein, capitalized terms not otherwise defined or amended in the Amendment shall have the meaning ascribed
to them in the Agreement. References to Articles or Sections are the same with all of their subparts as they appear in the Agreement.


 


	1.	Name Change: Effective
September 3, 2019, the company name Hemispherx Biopharma
, Inc. (“Hemispherx”) has been changed to AIM lmmunoTech, Inc. (“AIM”
). All references to Hemispherx shall be deleted and replaced with AIM.
	 	 
	2.	All references to
    Roswell Park Cancer Institute shall be deleted and replaced with Roswell Park Cancer Institute Corporation d/b/a Roswell Park
    Comprehensive Cancer Center.
	 	 
	3.	All references to
    Exhibit A shall mean the attached exhibit dated March 19, 2020 .
	 	 
	4.	Effect of the Amendment. From and after the Amendment No. I Effective Date, all references to the
    Agreement shall mean the Agreement as amended by this Amendment. Except as expressly amended by the Amendment, all of the
    provisions of the original Material Transfer and Research Agreement shall remain in full force and effect .


 







    	 	 	 



     


    

 





	Exhibit
    A
	Pl	 	Study

        Number
	 	ClinicalTrial.gov

                                                                                Identifier
	 	Description
	Gandhi-
                                         Kalinski
	 	

        

        I
        62218
	 	

        NCT03599453
	 	Pilot
    Open Label Clinical Trial Evaluating the Safety and Efficacy of Rintatolimod (Ampligen) based Chemokine Modulation to Enhance
    the Effectiveness of Pembrolizumab in Patients with Metastatic Triple- Negative Breast Cancer.
		 		 	 	 	 
	Puzanov
    - Kalinski	 	I
    82419*	 	

        

        NCT04093323
	 	A
    Phase II Study of Type-1 Polarized Dendritic Cell (αDC1) Vaccine in Combination with Tumor-Selective Chemokine Modulation
    (CMK: Interferon Alpha-2b, Rintatolimod (Ampligen), and Celecoxib) in Melanoma Patients with Primary PD-1/PD-Ll Resistance
	 	 	 	 	 	 	 
	Gandhi
    - Kalinski	 	I
    73718	 	

        

        NCT04081389
	 	Phase
    I Clinical Trial Assessing the Combination of Rintatolimod (Ampligen) based Chemokine Modulation with Neoadjuvant Chemotherapy
    in Triple Negative Breast Cancer.
	 	 	 	 	 	 	 
	Chatta
    - Kalinski	 	

        

        I
        77318
	 	

        

        NCT03899987
	 	Randomized
    Phase 2 Study: Neoadjuvant Conditioning of Prostate Cancer Tumor Microenvironment using a Novel Rintatolimod (Ampligen) based
    Chemokine-modulating Regimen
	 	 	 	 	 	 	 
	

        Fountzilas
        - Kalinski
	 	

        

        I
        74118*
	 	

        

        NCT04119830
	 	A
    Phase II Study of Rintatolimod (Ampligen) plus Pembrolizumab (Keytruda) in Refractory Metastatic Colorectal Cancer
	 	 	 	 	 	 	 
	

        

        Mukherjee
        - Kalinski
	 	

        

        I
        52917
	 	

        

        NCT03403634
	 	Phase
    2 Study Evaluating a Rintatolimod (Ampligen) based Chemokine-Modulatory Regimen in Patients with Colorectal Cancer Metastatic
    to the Liver
























 


* Study is not yet active as of 03/19/20


 




    	 	Page 2	 



     


    

 


IN WITNESS WHEREOF,
the respective Parties hereto have duly executed this Amendment as of the Amendment No.1
Effective Date above. The persons executing this Amendment represent and warrant that they have the full power and authority to
enter into this Amendment on behalf of the persons or entities for whom they are signing.


 


 


 







    	 	Page 3	 



    

 










  








		


 


July
14, 2017


 


Thomas
K. Equels, CEO


Hemispherx Biopharma, Inc.


860 N. Orange Ave., Ste. 8


Orlando,
FL 32801


 


Re:
Material Transfer and Research Agreement with RPCI


 


Dear
Mr. Equels:


 


Enclosed
is a fully executed original of the Material Transfer And Research Agreement between Hemispherx Biopharma, Inc. and Roswell Park
Cancer Institute, effective July 11, 2017. You will note that you executed it on July 11, 2017 and it was countersigned by Dr.
Victor A. Filadora, Chief of Clinical Services on July 14, 201 7. This document replaces the Material Transfer And Research Agreement
that you signed on July 11, 2017, which was countersigned by Dr. Thomas Schwaab, Chief of Strategy, Outreach and Business development
on July 11, 2017. That document should be destroyed to avoid confusion. As we discussed the Agreement that was countersigned by
Dr. Schwaab included minor redline changes that are apparent on the signature page. The redlines were simply accepted by Roswell
so that there is a clean Agreement. A comparison of the two documents will show that no substantive changes were made, but Roswell
preferred to have a clean document. Thank you for accommodating this request and apologies for the inconvenience.





 


	Very
        truly yours,

        
	 
	 	 
		 
	Elizabeth
        A.Ollinick

        
	 
	Associate
        General Co uns el

        
	 


 


Enc.


 


A
National Cancer Institute-designated Comprehensive Cancer Center ● A National Comprehensive Cancer Network Member A Blue
Distinction Center for Complex and Rare Cancerssm


 




    	 	 	 



     


    

 


MATERIAL
TRANSFER AND RESEARCH AGREEMENT


 


This
Agreement is made as of July 11, 2017, (“Effective Date”) by and between HEMISPHERX BIOPHARMA, INC. (“Hemispherx”),
a corporation incorporated under the laws of Delaware, and ROSWELL PARK CANCER INSTITUTE (“Institute”), having an
Office of Research at Elm & Carlton Streets, Buffalo, NY 14263 on behalf of Dr. Pawel Kalinski, an employee of the Institute.
Hemispherx and Institute shall be referred to individually as a “party” and together as the “parties.”


 


WHEREAS,
Institute wishes to receive Confidential Information pertaining to Hemispherx’s inventions and knowhow and also receive
samples of Hemispherx’s drug Ampligen® free of charge, solely for purposes of conducting clinical scientific research,
and


 


WHEREAS,
Hemispherx is willing to provide Confidential Inforrmation and Ampligen® to Institute solely for purposes of conducting clinical
scientific research on the following terms and conditions,


 


NOW
THEREFORE, in consideration of the premises and the mutual agreements and undertakings herein set forth, Institute and Hemispherx
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, 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.”


 


1.2
The “Research Project(s)”, described in the Exhibit(s) section, and appended by reference, are to be conducted by
Institute utilizing Confidential Information and Ampligen®, and are being funded by various entities independent of Hemispherx,
such as the National Institutes of Health, foundations, Department of Defense, or University support, etc. Parties agree that
each Research Project(s) described in the Exhibit(s) section under the Agreement is individually severable.


 


2.
PROVIDING OF MATERIAL, CONFIDENTIAL INFORMATION, AND PERFORMANCE OF THE RESEARCH PROJECT.


 


2.1
Hemispherx shall provide to Institute such Ampligen® as described in Exhibit(s) and which as may be reasonably requested by
Institute from time to time for purposes of the Research Project, and shall be used by Institute solely for the purpose of conducting
the Research Project.


 


2.2
The parties shall provide to each other such Confidential Information as is necessary for purposes of the Research Project.


 


2.3
The parties will utilize the Confidential Information exchanged solely for the purposes of conducting the Research Project.


 


2.4
Institute will promptly and diligently pursue the Research Project in a scientific manner, documenting in reproducible form the
work performed and results achieved in pursuing the Research Project.


 




    	 	2	 



     


    

 


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 arise out of the Research Project under this Agreement shall follow inventorship under U.S. patent law. Inventions made
solely by Institute shall be owned solely by the Institute. Inventions made solely by Hemispherx shall be owned solely by Hemispherx.
Inventions made by both parties shall be owned jointly. Institute shall grant to Hemispherx a non-exclusive, fully paid up right
to use Institute inventions for (i) internal research, development and regulatory purposes. Additionally, the Institute shall
grant a time limited right for a period of one hundred eighty (180) days to negotiate a commercial, royalty bearing license under
terms to be negotiated in good faith. If the parties fail to enter into license for the commercial use Invention(s) after said
one hundred eighty (180) day negotiation period, then Institute shall have no further obligation to Hemispherx regarding lnvention(s).
Hemispherx agrees to indemnify and hold harmless the Institute against any claim or loss that results from Hemispherx use of data
or licenses granted under this Agreement. The provisions of this Article 3 shall survive any termination or expiry of this Agreement.


 


4.
CONFIDENTIALITY.


 


4.1
The parties will employ the same degree of care to keep all Confidential Information confidential as they employ with respect
to their own information of like importance, which shall not constitute less than a reasonable standard of care, and will not
use any Confidential Information except for the express purposes of this Agreement and will not disclose any Confidential Information
received from the other party to any third party, except to consultants (employees are not third parties as this is a Institute
agreement) who are entitled to know such Confidential Information for the purposes of canying out the object of this Agreement,
and who are obligated to abide by all of the provisions of this Agreement. Nothing in this paragraph shall prevent a disclosing
party from disclosing or using its own Confidential Information as it wishes.


 


4.2
All Confidential Information shall remain the properly of the disclosing party. Upon the written request of a disclosing party
or upon termination or expiration of this Agreement, all tangible Confidential Information received from the disclosing party
(including all copies thereof and samples) shall be promptly returned to the disclosing party; provided that the receiving pai1y
may retain one (1) copy of such tangible Confidential Information in a secure location for purposes of identifying its obligations
under this Agreement.


 


4.3
The obligations of confidentiality and non-use set forth in this Article 4 of this Agreement shall not apply to any portion of
the Confidential Information that:


 


	 	(a)	is
    or becomes public or available to the general public without being wrongfully obtained or through breach of Agreement or is
    developed independently of Confidential Information received from the disclosing party; or
	 	(b)	was
    known to and evidenced by the receiving party’s written records prepared prior to the date of this Agreement; or
	 	(c)	is
    properly obtained by the receiving party from a third party with a valid legal right to disclose such Confidential Information
    and such third party is not under a confidentiality obligation to the disclosing party; or
	 	(d)	is
    released by the disclosing party to a third party without restriction.



 









    	 	3	 



     


    




 


4.4
In the event that a receiving party is requested or required (by deposition, interrogatories, request
for information or documents in legal proceedings, subpoena, civil investigative demand or other similar process) to disclose
any of the Confidential Information, the receiving party shall provide the disclosing party with prompt written notice of any
such request or requirement so the disclosing party may seek a protective order or other appropriate remedy and/or waive compliance
with the provisions of this Confidentiality Agreement. If, in the absence of a protective order or other remedy or the receipt
of a signed written waiver, the receiving party or its representatives ate nonetheless, in the written opinion of their
counsel, legally compelled to disclose Confidential Information to any governmental or regulatory body or else stand liable for
contempt or suffer such other censure or penalty, receiving party may, without liability hereunder, disclose to such body only
that portion of the Confidential Information which such counsel advises the receiving party is legally required to be disclosed,
provided that the receiving party exercised efforts to allow the disclosing party to use its reasonable efforts to preserve the
confidentiality of the Confidential Information.


 


4.5
Nothing in this Agreement shall be construed as giving a receiving party any right, title, interest in or ownership of the Confidential
Information.


 


4.6
The provisions of this Article 4 shall survive any termination or expiry of this Agreement for a period of five (5) years.


 


5.
DISCLOSURE


 


5.1
Institute shall, on a semi-annual basis provide information in writing to Hemispherx regarding the progress, status and results
of the Research Project including efficacy and safety data; and in addition any reports related to the Research Project submitted
to any IRB or the FDA. Such results are provided without warranty of any type and Institute shall not be liable to Hemispherx
in any way for use of such results.


 


5.2
If requested by Hemispherx, Institute Principal Investigator(s) will confirm within a reasonable period of time any oral progress
reports with follow-up summary written reports. Principal Investigator(s) will provide Hemispherx with a final written report
within sixty (60) days after the conclusion of each study described in the Exhibit(s) section. The written reports will include
descriptions of the methods used and results obtained together with any other pertinent findings from the Project.


 


5.3
During and for a period of at least two years after the completion of the Research Project, Hemispherx shall promptly (or in a
timely manner appropriate to the level of risk) report to the Research Project participants any information that could directly
affect the health or safety of past or current Research Project participants or influence the conduct of study, including but
not limited to the results and information in site monitoring reports. In each case, the Institute and Principal Investigator
shall be free to communicate these findings to each Research Project participant and the IRB.


 


6.
INDEMNIFICATION.


 


6.01
Research Project Participant Injury. Institute will offer, and if accepted, provide necessary emergency medical treatment to Research
Project participants who suffer adverse reaction or injury during participation in the Research Project. Hemispherx will reimburse
Institute for providing such medical treatment, to the extent the adverse reaction, treatment of any injury or illness directly
related to the Ampligen®, but only to the extent that such illness or injury is not due to (i) any other drug or treatment
that the Research Project participant is receiving, which includes commonly recognized side effects of such other drug or treatment;
(ii) the normal progression of the disease; or (iii) the negligence or malfeasance of the Research Project participant or the
failure of any one or more of them to comply with good clinical practice, the protocol, or any applicable law or regulation. Hemispherx
will not reimburse the Institute to the extent that any illness/injury is due to the negligence of the Institute,
including improper administration of the drug.


 




    	 	4	 



     


    

 


Indemnification.
Hemispherx shall indemnify, defend and hold harmless Institute, its trustees, directors, officers, employees (collectively,
the “Institute Indemnitees”) 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 any side effect, adverse reaction,
illness or injury occurring to any Research Project participant as a direct result of the proper use of the Ampligen® in
the Research Project. The foregoing indemnity will not apply to the extent (i) a Claim arises out of or relates to the
Institution’s negligence or willful misconduct; (ii) failure to adhere to any written instructions from Hemispherx or
its designee. The Institute will indemnify, defend and hold harmless Hemipherx where the aforementioned (i) and/or (ii) are
the grounds for Institution’s liability.


 


7.
TERMINATION.


 


7.1
This Agreement shall terminate upon the earlier of (a) the completion of the Research Project, (b) the written agreement signed
by authorized representatives of the parties, or (c) three years from the Effective Date.


 


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 Fedex or other courier), or when sent by facsimile, addressed as follows:


 


To
Institute:


Clinical
Research Services


Elm & Carlton Streets


Buffalo, NY 14263


Attn:
Laurie Musial


 


To
Hemispherx:


David
R. Strayer, MD


Hemispherx Biopharma, Inc.


1617 JFK Boulevard, Suite 500


Philadelphia,
PA 19103


 


Or
such other address as either 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 is the entire agreement between Institute and Hemispherx 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 Institute and Hemispherx.


 


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.


 




    	 	5	 



     


    

 


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.


 


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 New York, U.S.A. without regard to the application of conflict laws.


 


IN
WITNESS WHERE OF, the parties have executed this Agreement as of the Effective Date.