Document:

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.

 

EXHIBIT
10.3

 

MATERIAL
TRANSFER AND RESEARCH AGREEMENT

 

This
Agreement is made as of June 22, 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 a collaborative group consisting of Japanese National Institute of Infectious Disease (“NIID”)
with its address at 4-7-1 Gakuen, Musashimurayama-shi, Tokyo, 208-0011 Japan, and Shionogi & Co., Ltd. (including its
affiliates, “Shionogi”) with its address at 1-8, Doshomachi 3-chome Chuo-ku, Osaka 541-0045 Japan (together referred
to as the “Companies”). AIM, Shionogi and NIID shall be referred to individually as a “Party” and together
as the “Parties.” 

 

WHEREAS,
the Companies wish 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 Exhibit A (“Research
Projects”). It is the shared goal of all 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 Shionogi and NIID 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. 

 

NOW
THEREFORE, in consideration of the premises and the mutual agreements and undertakings herein set forth, Companies 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but not limited to trade secrets and unpublished patent applications, pre-clinical and clinical information or data, technical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 April 21, 2020 (“Confidentiality
Agreement”) which is incorporated by reference herein.

 

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 AlMs 8K, 10K
and 10Qs that address AIM’s contractual relationships. For clarity, it is agreed by the Parties that such reports shall not contain
the detailed description of the Research Project including contents of Exhibit A. 

 

2.
PROVIDING OF MATERIAL FOR THE RESEARCH PROJECTS.

 

2.1
AIM shall provide to the Companies such Ampligen® free of charge as described in Exhibit A and which as may be reasonably
requested by the Companies from time to time for purposes of the Research Projects, and shall be used by the Companies solely
for the purpose of conducting the Research Projects.

 

     

     

    

 

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.

 

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

 

2.3
The Companies will utilize the Confidential Information exchanged solely for the purposes of conducting the Research Projects.

 

2.4
The Companies 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. 

 

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 the Companies shall be owned solely by the Companies. Inventions made by multiple 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®. 

 

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, Japan, 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.

 

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 Companies 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. 

 

     

     

    

 

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.

 

5.2
The Companies will provide AIM with an oral report every three (3) months and with a final written report within sixty (60) days
after the conclusion of Research Projects described in the Exhibit A. If requested by AIM, the Companies 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.

 

5.3
It is understood that Research Projects is currently ongoing at NIID and it is a preliminary experiment utilizing aliquots of
Ampligen® already sent to NIID. The additional aliquots of Ampligen® mentioned in this Agreement are for follow up experimental
activity to continue the Research Projects. In addition, by mutual agreement, this Agreement may be amended to add or revise Exhibits
as new experiments and related activities are undertaken. Each revision and amendment shall be agreed to and signed by all the
Parties as added. 

 

5.4
Other than the initial request by NIID for 30 aliquots of Ampligen® 1.0 ml at 2.5 mg/ml, which was already received by NIID,
additional Ampligen will be supplied by AIM to Shionogi or NIID in the amount as listed in Exhibit A. Any Ampligen® aliquots
delivered pursuant to this Agreement shall not be sold, distributed or otherwise made available by Companies to any other party
for any other purpose. There is no obligation to supply any further amounts of Ampligen® unless the Parties mutually agree
it is needed to complete 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.

 

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
National Institute of Infectious Disease: 

 

Hideki
Hasegawa, M.D., Ph.D.

4-7-1Gakuen,Musashimurayama-shi,

Tokyo, 208-0011 JAPAN

 

     

     

    

 

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.

 

To
Shionogi & Co., Ltd.: 

 

Yasuyoshi
Isou, Ph.D.

1-8,
Doshomachi 3-chome Chuo-ku,

Osaka 541-0045 Japan 

 

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 the Companies 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 the Companies 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. 

 

8.5
Remedies. The Companies 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.

 

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.

 

     

     

    

 

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.

  

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

 

	AIM  ImmunoTech,
    Inc. 	 	 
	 	 	 	 
	By:
       	 /s/
    Thomas K. Equels	 	Date:
    06/26/2020
	Name:  	Thomas  K.  Equels
    	 	 
	Title:   	Chief  Executive  Officer
    	 	 

 

	Japanese  National  Institute  of  Infectious  Disease 
	 	 	 	 
	By:
       	/s/
    Hideki Hasegawa	 	Date:
    07/01/2020
	Name:  	Hideki  Hasegawa,  M.D.,  Ph.D.
    	 	 
	Title:   	Director,  Influenza  Virus  Research  Center
    	 	 

 

	Shionogi  &  Co.,  Ltd.
    	 	 
	 	 	 	 
	By:
       	/s/
    Yasuyoshi Isou 	 	Date:
    06/26/2020
	Name:  	Yasuyoshi
    Isou, Ph.D.	 	 
	Title:   	Corporate  Officer	 	 
	 	Senior
    Vice President, CMC R&D Division	 	 

 

     

     

    

 

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.

 

Exhibit
A — Research Projects

 

I.
Studies to be conducted evaluating Ampligen as an *** vaccine adjuvant:

 

***

 

II.
Necessary Amounts of Ampligen®:

 

***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.

 

EXHIBIT
10.4

 

CLINICAL
TRIAL AGREEMENT

 

THIS
AGREEMENT (“Agreement”), made as of the date of last signature (“Effective Date”), by and between
ROSWELL PARK CANCER INSTITUTE CORPORATION D/B/A ROSWELL PARK COMPREHENSIVE CANCER CENTER (“Institution”),
a New York State public benefit corporation, with its principal office located at Elm and Carlton Streets, Buffalo, NY 14263,
employer of, Brahm Segal, MD (“Principal Investigator”), and AIM ImmunoTech Inc. (hereinafter “AIM”),
a corporation with its principal place of business at 2117 SW Highway 484, Ocala, Florida 34473. The Institution and AIM together
are referred to herein as the Parties.

 

WITNESSETH:

 

WHEREAS,
institution is conducting a clinical Study (“Study”) to “Phase 1b Trial of Rintatolimod and IFNα Regimen
in Cancer Patients with Mild or Moderate COVID-19 infection;” and

 

WHEREAS,
AIM is providing Rintatolimod, also known as Ampligen® (“Study Drug”), information, and funding to Institution
as a collaborator and partner of the Study and in support of the Study; and,

 

WHEREAS,
Institution is a National Cancer Institute-designated Comprehensive Cancer Center and conducts clinical research studies designed
to test, inter alia, methods of preventing cancer and

 

WHEREAS,
AIM is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancer;
and

 

WHEREAS,
Institution has reviewed sufficient information regarding the Study Drug and has prepared the Protocol for the Study, and
desires to conduct the Study as Study Sponsor.

 

NOW,
THEREFORE, in consideration of the premises and for other good and lawful consideration, receipt of which is acknowledged,
the Parties agree as follows:

 

1.
Study Protocol

 

Institution
will conduct the Study in accordance with “***” and any, subsequent amendments thereto, incorporated by reference
herein (the “Protocol”). The Protocol fully details the clinical research activities and responsibilities to
be undertaken, pursued, and followed with all due diligence, by Institution. The Protocol will be considered final after it is
approved by the Institution’s Institutional Review Board or another designated Institutional Review Board (“IRB”).
Institution will provide AIM with the final Protocol, which shall be considered Confidential Information pursuant to section 8
of this Agreement before commencement of the Study. Thereafter, the Protocol may be amended only following consultation with AIM
and consent of the Institution and subsequent approval by the IRB.

 

    	 	-1-	 

     

    

 

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.

 

2.
Conduct of Study

 

	 	a.
    	Standards.
    Institution agrees to conduct the Study in accordance with generally accepted standards of professional medical practice,
    and in compliance with: (i) applicable standards of good clinical practice (“GCP”), (ii) the Protocol, and (iii)
    any and all applicable federal, state, and local laws, regulations, and any other relevant professional standards (“Applicable
    Laws”). Institution may subcontract its responsibilities under this Agreement to subsites (“Subsites”),
    provided that such Subsite shall be bound by the same or comparable obligations that Institution has agreed to assume in this
    Agreement for those specific obligations the Subsite agrees to undertake.
	 	 	 
	 	b.
    	ClinicalTrial.gov.
    AIM shall be listed on the clinicaltrial.gov website as a collaborator on this study. In the event, AIM and Institution
    agree that errant information posted on clinicaltrial.gov website regarding this Study, Institution will submit and request
    corrections in a timely manner.
	 	 	 
	 	c.
    	Conduct
    of Study. Institution further agrees that in the performance of the Study their employees and agents shall:

 

	 	i.	Obtain
    from each Study subject a signed consent form (“Informed Consent Form”) in accordance with the Protocol and template
    informed consent form which has been approved by the IRB in accordance with 21 CFR §56, et, seq., or any successor thereto.
	 	ii.	Perform
    the Study with reasonable care, diligence and skill and ensure that personnel participating in the Study are competent and
    have appropriate professional qualifications, training and experience.
	 	iii.
    	Promptly
    notify the IRB of any failures to comply with the Protocol ( deviation where necessary to eliminate an immediate hazard(s)
    to Study subjects or from the Protocol arising out of medical necessity for Study subject safety shall not be deemed a failure
    to adhere to the Protocol),
	 	iv.
    	Maintain
    complete and accurate records of the status and progress of the Study as required by the Protocol and with sufficient legibility
    and detail for use by regulatory agencies (“Study Records”). The Study Records shall include: case report
    forms; records reflecting the receipt and disposition of the Study Drug, including all dates, quantity and use by Study subjects;
    Study safety data required by the Protocol; records of Study subject identification; and clinical observations and laboratory
    tests as required in the Protocol.
	 	v.
    	Institution
    will notify AIM within two (2) business days of receiving FDA authorization to initiate the Study.
	 	vi.
    	Institution
    shall notify AIM within two (2) business days of when first treatment of Study Drug is administered and when first combination
    cohort Study Drug plus IntronA is administered pursuant to the Protocol. However, Institution is obligated to confirm in a
    confidential communication whether any dose-limiting toxicity was observed in the initial cohort before implementing the combination
    cohorts. For the avoidance of doubt, such communication shall be treated as Confidential Information, ( as defined below)
    by the Parties

 

    	 	-2-	 

     

    

 

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.

 

	 	vii.
    	Ensure
    that Confidential Information (as defined below) generated by Institution, or its respective employees or agents is accurate,
    complete, and legible.
	 	viii.
    	Ensure
    that Principal Investigator is not currently participating, and shall not participate, in any study which by its nature will
    preclude Principal Investigator from conducting the Study.
	 	ix.
    	Ensure
    that neither it, nor any of its employees directly involved with the conduct of the Study, including the Principal Investigator,
    has ever been, or is currently:

 

	 	●	an
    individual who has been debarred by the FDA pursuant to 21 U.S.C. §335a(a) or (b) from providing services in any capacity
    to a person that has an approved or pending drug product application (a “Debarred Individual”), or an employer,
    employee, or partner of a Debarred Individual; or
	 	●	 a
    corporation, partnership, or association that has been debarred by the FDA pursuant to 21 U.S.C. § 33% (a) or (b) from
    submitting or assisting in the submission of any abbreviated drug application (a “Debarred Entity”), or an employee,
    partner, shareholder, member, subsidiary, or affiliate of a Debarred Entity; or
	 	●	an
    individual or corporation, partnership, or association that has been barred from participation in a Federal Health Care Program
    (as defined in 42 U.S.C. § 1320a (7b (f)), as amended from time to time or in any other governmental payment program.

 

	 	x.
    	Nothing
    in this agreement shall prevent AIM from conducting other clinical research studies intravenously or otherwise at other institutions
    and in other countries related to Ampligen for Cancer, or as an early onset Therapy /Prophylaxis or vaccine adjuvant for SARS-CoV-2/COVID
    19. For the avoidance of doubt, nothing in this provision shall be construed as allowing AIM to utilize the protocols drafted
    by and belonging to Roswell Park and its employees.

 

3.
Study Drug

 

	 	a.	AIM
    will furnish an agreed upon number of vials of Study Drug, approximately *** vials, *** to the Institution pursuant to this
    Agreement solely for use in the Protocol. ***
	 	b.	Institution
    will store, handle and administer Study Drug under adequately controlled conditions and in accordance with the Protocol, and
    Study Drug information provided by AIM.
	 	c.
    	Institution
    will return or destroy Study Drug in accordance with written directions of AIM and with Institution’s drug destruction
    policies. The Study Drug delivered pursuant to this Agreement shall not be sold, distributed or otherwise made available by
    the Institution to any other party for any other purpose, without the written consent of AIM, which written consent shall
    not be unreasonably withheld.
	 	d.
    	Institution
    will not bill any Study subject or any third parties for any service or activity that is funded in accordance with this Agreement
    or any Study Drug that is supplied by AIM under this Agreement.
	 	e.
    	The
    Parties acknowledge that the Study Drug is being provided “as is,” without any warranties or representations of
    any sort, express or implied, including without limitation warranties of merchantability and fitness for a particular use.
    AIM makes no representation and provides no ‘warranty that the use of the Study Drug in the Study will not infringe
    any patent or other proprietary right of third parties.

  

    	 	-3-	 

     

    

 

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.

 

4.
Privacy Laws

 

Institution
will ensure that any of its employees, including Principal Investigator, and persons performing the Study on the Institution’s
behalf will comply with all applicable federal and New York state laws and regulations governing privacy and confidentiality of
health information, including without limitation, the Health Insurance Portability and Accountability Act of 1996 and implementing
regulations (“HIPAA”), as well as confidentiality agreements entered into by the Parties.

 

5.
Adverse Events

 

	 	a.
    	Adverse
    Events. Institution will ensure that its personnel comply with notification procedures provided
    in the Protocol and Applicable Law, including time limits in the reporting of adverse events of pregnancy, serious
    adverse events including death, unexpected adverse events and severe adverse events determined
    to be related or possibly related to the Study Drug. Institution shall notify IRB and AIM's Medical Monitor (email at SAE@aimimmuno.com)
    of any of the above "Adverse Events" on a quarterly basis. Adverse event reporting to AIM shall be completed
    on a quarterly basis and will be initiated upon the written request of AIM to the Institution's counsel.
	 	 	 
	 	b.	Reporting
    by AIM. AIM shall notify Institution promptly and in writing of any information that could affect the safety of Study
    subjects or their willingness to continue participation, influence the conduct of the Study, or alter the IRB’s approval
    to continue the Study. AIM shall communicate such information to Institution and Principal Investigator that may directly
    affect the Study subject’s safety or medical care for a period of at least two (2) years following the end of the Study.
    Subject to other terms of this Agreement, Institution, through its Principal Investigator and/or IRB, as appropriate, will
    inform Study subjects of additional information in accordance with IRB direction.
	 	 	 
	 	e.	Reporting
    by Institution: Institution shall notify AIM of adverse events in section 5.a above. In addition, Institution shall provide
    IND Safety Reports to AIM at the time of report to FDA or as soon as possible thereafter, according to FDA Reporting time
    frame specified in Protocol. At study completion, Institution will provide final safety data / listing of all adverse events
    (including but not limited to severity, relationship to each study medication, to the COVID-19, or to baseline co-morbidities,
    i.e., cancer, and start and stop dates of each event). Adverse events that result in death shall also capture the above information.

 

6.
Term, Termination, and Replacement of Principal Investigator

 

	 	a.
    	Term.
    This Agreement shall commence on the Effective Date and shall continue until the completion of the Study or such other
    date as may be agreed to by the Parties (“Term”).

 

    	 	-4-	 

     

    

 

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.

 

	 	b.
    	Termination
    Prior to Expiration. This Agreement may be terminated, in whole or in part, by the Parties prior to the expiration of
    its Term upon written notice, if any of the following conditions occur:

 

	 	i.
    	By
    either party, effective upon notice, if authorization and approval to conduct the Study is withdrawn by the FDA or other regulatory
    authority.
	 	ii.
    	By
    either party, effective upon notice, if in the reasonable and good faith opinion of Principal Investigator, Institution, and/or
    AIM the Study should be terminated for safety reasons.
	 	iii.
    	By
    AIM, effective upon notice, if Principal Investigator or Institution becomes disbarred
	 	iv.
    	Upon
    written mutual agreement or upon thirty (30) days’ notice for uncured breach of this Agreement.

 

	 	c.
    	Termination
    of this Agreement shall not affect any rights or obligations of the Parties that occurred prior to termination of this Agreement
    or rights or remedies of either party available at law or in equity.
	 	 	 
	 	d.	 Replacement
    of Principal Investigator. In the event Principal Investigator becomes either unwilling or unable to perform the duties
    required by this Agreement, upon request by AIM, Institution will cooperate, in good faith and expeditiously, to find a replacement.
    The Institution’s cooperation in finding an acceptable replacement does not negate their obligations to perform this
    Agreement up to the effective date of termination.

 

7.
Payment

 

The
Parties acknowledge that Health Research Inc., Roswell Park Division, a New York non-profit corporation, is authorized to manage
funds from clinical research, on behalf of Institution, has an office of Elm and Carlton Streets, Buffalo, New York 14263 and
is the Institution’s payee (“Payee”), In consideration for performance of the Study and as a collaborator of
this Study, AIM will provide funding to Institution, through its Payee and will provide Institution $***. Payments to be distributed
as follows:

 

Study:
***

 

8.
Confidential Information

 

		a.	Definition.
                                         “Confidential Information” will mean all information or data provided
                                         by one party to another that a reasonable person familiar with the area would recognize
                                         as confidential or proprietary information and materials (whether or not patentable)
                                         identified in writing as “Confidential.” In addition, Confidential Information
                                         includes, but is not limited to clinical data expressly required to be collected by the
                                         Study Protocol or pursuant to the terms of this Agreement, the Investigational Drug/Device
                                         Brochure, Study Records, preclinical data and formulation information, patent applications,
                                         audit reports, study reports, formulas and manufacturing processes, provided or made
                                         available to either party.

  

    	 	-5-	 

     

    

 

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.

 

		b.	Obligations.
                                         Each party shall maintain in strict confidence all of the other party’s Confidential
                                         Information and not disclose or disseminate to any third party or use for any purpose
                                         other than the performance of the Study. Such Confidential Information shall remain the
                                         confidential and proprietary property of the disclosing party, and, shall be disclosed
                                         only on a need-to-know basis to employees and agents who are bound by confidentiality
                                         terms at least as strict as those herein. 

 

		c,	Non-applicability.
                                         The foregoing obligation of non-disclosure shall not apply to Confidential Information
                                         to the extent such information:

 

	 	i.
    	was
    available in the public domain at the time of disclosure or subsequently becomes publicly available through no fault of the
    receiving party;
	 	 	 
	 	ii.	 is
    disclosed to receiving party by a third party entitled to disclose such information not subject to any obligation of confidentiality,
    as shown by prior written records
	 	 	 
	 	iii.	is
    already known to receiving party prior to disclosure hereunder, as shown by prior written records; or
	 	iv.	 is
    independently developed by receiving personnel without reliance on Confidential Information, as shown by prior written records

 

	 	d.	Allowable
                                         Disclosures. Confidential information may be disclosed to the extent it is required by
                                         Applicable Laws to be disclosed to US federal, state, or local authorities and agencies
                                         including the Food and Drug Administration (“FDA”) or the Securities and
                                         Exchange Commission (“SEC”), provided that such disclosure is subject to
                                         all applicable governmental or judicial protection available for like material and reasonable
                                         advance notice of such request is given to the other party.
	 	 	 
		e.	Equitable
                                         Remedies. Parties acknowledge and agree that ally violation of the terms of this
                                         Agreement relating to the disclosure or use of Confidential Information may result in
                                         irreparable injury and damage to disclosing party not adequately compensable in money
                                         damages, and for which disclosing party will have no adequate remedy at law. Nondisclosing
                                         party acknowledges and agrees that if those disclosure terms are violated, then disclosing
                                         party has a right to seek injunctions, orders, or decrees to protect the Confidential
                                         Information.
	 	 	 
	 	f.	Period
                                         of Confidentiality. The obligations of the Parties under this Section 8 shall continue
                                         until ten (10) years from the expiration or termination of this Agreement.
	 	 	 
	 	g.	Recordkeeping.
                                         In accordance with Applicable Law, upon completion of the Study or earlier termination
                                         of this Agreement pursuant to section 6, all Study Drug and related materials and all
                                         Confidential Information that were furnished under this Agreement will be returned, except
                                         for record copies which nondisclosing Party is required to retain and a copy maintained
                                         to monitor compliance with this Agreement, Neither Party shall be required to delete
                                         or destroy any electronic back-up tapes or other electronic back-up files that have been
                                         created solely by their automatic or routine archiving and back-up procedures, to the
                                         extent created and retained in a manner consistent with its or their standard archiving
                                         and back-up procedures.

 

    	 	-6-	 

     

    

 

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.

 

9.
Publication

 

	 	a,
    	For
    purposes of this Agreement, Scientific Publication means any scientific publication or medical communication regarding Study
    results in any form that is intended for disclosure to third parties, including, without limitation, manuscripts, abstracts,
    posters, slides or other materials used for presentations.
	 	b.
    	Scientific
    Publications should be published in a timely manner, in accordance with industry standards, and present scientific information
    in an accurate and balanced way that does not exclude or inappropriately downplay negative safety or health information. Authorship
    related to Scientific Publications shall be determined in accordance with and governed by the criteria defined by the International
    Committee of Medical Journal Editors (ICMJE) Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly
    Work in Medical Journals.
	 	c.
    	Institution shall provide and shall require Principal Investigator
to provide AIM with a draft of
    any proposed Scientific Publication at least thirty (30) days prior to submission of such publication for AIM to ascertain
    whether any patentable subject matter or Confidential Information (other than the results of the Study generated hereunder)
    are disclosed therein. AIM shall provide a response to Institution within thirty (30) days after receipt of the draft Scientific
    Publication ( “Review Period”). Institution shall delay any proposed Scientific Publication an additional sixty
    (60) days in addition to the Review Period in the event AIM so requests to enable AIM to secure patent or other proprietary
    protection (“Delay Period”). Institution agrees to (i) keep the proposed Scientific Publication confidential until
    expiration of the Review Period and any Delay Period, and (ii) delete Confidential Information (other than the results of
    the Study generated hereunder) from any Scientific Publication. In the event that Institution and AIM differ in their conclusions
    or interpretation of data in the Scientific Publication, the Parties shall use good faith efforts to attempt to resolve such
    differences through appropriate scientific debate, but, subject to the removal of Confidential Information (other than the
    results of the Study generated hereunder), Institution, as applicable, shall retain control over the final version of the
    Scientific Publication. 
	 	 	Nothing
    herein affords AIM editorial rights with respect to Institution’s publications.

 

10.
Intellectual Property

 

	 	a.	Pre-existing
    Property. Institution understands and acknowledges that the Study Drug, Ampligen® (rintatolimod) is the property of
    AIM and/or that it may be subject to certain intellectual property rights owned by or licensed to AIM including patents, patent
    applications that may issue as patents in the future, trademarks and trademark applications. All rights to Ampligen® (rintatolimod)
    belong to AIM. This Agreement shall not be deemed or construed to convey, transfer, or license any of such intellectual property
    rights to Institution, other than the limited rights necessary to permit Institution to conduct the Study during the term
    of this Agreement, Further, all intellectual property belonging to either party prior to the execution of this Agreement (“Pre-existing
    Property”) shall remain the separate property of that party and nothing contained in this Agreement shall be deemed
    to grant either directly or by implication, estoppel or otherwise any license under any patents, patent applications, trademarks,
    trade secrets, or other proprietary interests to Pre-existing Property of the other party. 

 

    	 	-7-	 

     

    

 

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.

 

	 	b.
    	New
    Inventions. Ownership and rights to any new and patentable or unpatentable discovery, technology, know-how or other intellectual
    property arising from the performance of the Protocol (hereinafter “Other Inventions”) shall be determined by
    the application of U.S. patent laws.

 

11.
Audits and Inspections

 

	 	a.
    	Institution
    shall notify AIM, or if instructed, its representative, promptly if the FDA or other duly authorized authority requests permission
    to or does inspect Institution’s facilities or research records during the term of this Agreement. Institution will
    make reasonable efforts to ensure the Principal Investigator and other requested personnel, are available for any meeting
    or conference calls with the FDA concerning the approval of the Study Drug.

	 	 	 
	 	b.	Institution
    will permit AIM or AIM’s representatives to examine or audit the financial records related to such work, agreed upon
    times during regular business hours. , Institution shall provide AIM’s representatives with reasonable access to such
    records. Information regarding Institution’s systems, the information therein, and any incidental information that would
    be understood by a reasonable professional in the field to be confidential shall remain the property of Institution and will
    be treated as Institution’s Confidential Information by AIM’s representatives.

  

12.
Use of Names

 

AIM
and Institution shall not disclose publicly the terms of this Agreement, except to the extent required by academic policies or
law. No news release, publicity or other public announcement, either written or oral, regarding this Agreement or performance
hereunder or results arising from the Study, shall be made by a Party without the prior written approval of the other except as
set forth in this section. Written approval shall not be required for the purposes of (i) announcing FDA authorization to initiate
the Study following disclosure by Institution to AIM in a press release or (ii) when stating in part that the Study is supported
by AIM in a press release.

 

13.
Independent Contractors

 

Each
party to this Agreement shall act as an independent contractor and shall not be construed for any purpose as the partner, agent,
employee, servant, or representative of the other party. Accordingly, the employee(s) of one party shall not be considered to
be employee(s) of the other party, and neither party shall enter into any contract or Agreement with a third party which purports
to obligate or bind the other party.

 

    	 	-8-	 

     

    

 

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.

 

14.
Complete Agreement. Amendment. Notice

 

The
Parties agree that this Agreement constitutes the sole, full, and complete Agreement by and between the Parties concerning the
Protocol and supersedes all other written and oral agreements and representations between the Parties with respect to the items
herein, except where in conflict with the Protocol, No amendments, changes, additions, deletions, or modifications to or of this
Agreement shall be valid unless reduced to writing and signed by the Parties. Any requests for changes or amendments or other
notices or communications concerning this Agreement should be in writing or shall be deemed to have been given when mailed by
personal delivery, nationally recognized courier, and shall be deemed effective only upon receipt, and forwarded to the following:

 

	 	To
    AIM: 	AIM
    ImmunoTech Inc,
	 	 	2117
    SW Highway 484
	 	 	Ocala,
    Florida 34473
	 	 	Attn:
    David Strayer, MD
	 	 	 
	 	To
    Institution: 	Roswell
    Park Cancer Institute Corporation d/b/a Roswell Park
	 	 	Comprehensive
    Cancer Center
	 	 	Elm
    and Carlton Streets Buffalo NY 14263
	 	 	Attn:
    VP, Clinical Research Services
	 	 	 
	 	With
    a copy to:	Attn:
    General Counsel (same address)
	 	 	 
	 	To
    Investigator: 	Brahm
    Segal, MD
	 	 	Pawel
    Kalinski, MD, PhD (same address)

 

15.
Compliance with 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 without regard to the application of conflict laws.

 

16.
Reporting

 

Institution
will provide AIM with the final study report (including all adverse events with severity and relationship to Study Drug) and any
interim reports, such interim reports are prepared by Institution in its sole discretion (“Reports”). In order to
maintain the integrity of the Study as required by the Protocol. Reports shall be considered Confidential Information and shall
not be disclosed for any public dissemination without Institution’s prior written consent.

 

    	 	-9-	 

     

    

 

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.

 

Such
interim data reports may include, interim efficacy data necessary to maintain the integrity of the study as dictated by the protocol
and interim analysis conducted by a statistician to inform on futility. Such interim and final reports are not intended for disclosure
other than to AIM employees who require the information in order to complete their duties. For the avoidance of doubt, such interim
and final data reports shall not be disclosed publicly and shall not be disclosed to non-AIM employees or consultants or for broad
public dissemination without Institution’s prior written consent; in addition all such reports may be submitted without
Institution’s consent by AIM to the FDA (or other regulatory agency or governmental authority) for purposes of Emergency
Approval, Orphan Drug Status, Fast Track Status and New Drug Approval consideration upon receipt due to the urgency of the current
COVID-I9 pandemic.

 

In
addition, upon completion of the Study once the results are finalized, the results will be published in accordance with Section
9 of this Agreement in a fashion that is publicly available. AIM will be entitled to use the published results as they deem necessary.
Nothing in this provision shall be deemed to provide AIM with editorial rights on the nature of the results that will be published.

 

Additionally,
Institution agrees that to the extent that there is positive data that would support FDA Fast Track status or an Emergency Approval,
Institution will submit the interim data to AIM, in Institution’s reasonable discretion and to allow AIM to submit and file
for necessary approval with the appropriate agencies.

 

17.
Insurance

 

The
Parties shall maintain insurance or a program of self-insurance in commercially reasonable amounts for the nature of services
being performed.

 

18.
Binding, Effect

 

This
Agreement shall be binding upon the Parties, their legal representatives, successors, and assigns. The obligations of the Parties
contained in Sections 5 (Adverse Events and Study subject Injury), 8 (Confidential Information), 9 (Publication), 10 (Intellectual
Property), shall survive the termination or expiration of this Agreement.

 

19.
Waiver

 

Failure
to insist upon compliance with any of the terms and conditions of this Agreement shall not constitute a general waiver or relinquishment
of any such terms or conditions, and the same shall remain at all times in full force and effect.

 

20.
Assignment

 

Neither
Party shall assign or transfer any rights, obligations or duties under this Agreement.

 

    	 	-10-	 

     

    

 

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.

 

21.
Force Majeure

 

21.1
Non-fulfillment, delay or omission by any of the Parties as regards of any and all of the obligations imposed by this Agreement
will not be considered a breach of the Agreement, nor will it entail any liability when it is the result of Force Majeure. Force
Majeure will be understood to comprise any extraordinary event, unforeseeable, or if foreseeable, an inevitable event, such as
labor disputes, fire, mobilization, public health emergencies, insurrection, war, natural disasters, the prohibition of a government
to not supply to a national company or organization, damages caused by the application of extraterritorial laws, embargoes and
blockades imposed by third countries to any of the Parties, among others, that may occur or remain in force after the signing
of this Agreement which may impede the partial or total fulfillment by the Parties of the obligations pursuant to this Agreement.
The Party that invokes Force Majeure must notify the other Party in writing, within a period of thirty (30) days following the
date of occurrence of the event or events constituting Force Majeure. This notification must be supported by a document issued
for a competent authority and shall be duly certified. The document containing the above-mentioned information will be sent by
courier delivery service within a period of thirty (30) days following the date of the initial notification.

 

21.2
If the event or events defined as causes determining an exemption from responsibility or Force Majeure persist for more than ninety
(90) consecutive days, the Parties will, within the following sixty (60) days, meet in the most convenient place to examine all
issues in the spirit of finding the best solution, and agree on all the steps, terms and conditions required to normalize the
situation, without prejudice to the contracted obligations thus affected.

 

21.3
In the event that no such Agreement is reached on the steps, terms or conditions within the aforementioned period of sixty (60)
days or in the event that such an Agreement is reached but not fulfilled under the terms and conditions agreed upon, the Party
affected by the non-fulfillment may request the termination of the Agreement, and must be accepted by the other Party and will
be in force the fulfillment of the pending payments.

 

22.
Severability

 

If
any term or condition of this Agreement, the deletion of which would not adversely affect the receipt of any material benefit
by a party hereunder, shall be held illegal, invalid or unenforceable, the remaining terms and conditions of this Agreement shall
not be affected thereby and such terms and conditions shall be valid and enforceable to the fullest extent permitted by law.

 

23.
Miscellaneous

 

No
delay by a Party to exercise any right or a non-exercise of it by the Party under this Agreement or the applicable law shall operate
as a waiver of such right. The exercise in part of a right shall not preclude any other exercise or future exercise of such right
or remedy deriving from it.

 

    	 	-11-	 

     

    

 

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.

 

24.
Authority

 

Each
of the Parties hereto certifies that the person signing below on such party’s behalf has the authority to enter into this
Agreement, and that this Agreement does not violate any existing agreement or obligation of such party.

 

IN
WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed as of the last date and year below written.

 

	 	AIM
    ImmunoTech, Inc.	 
	 	 	 
	 	Name:	s/Thomas
    K. Equels	 
	 	 	 	 
	 	Title:
    	CEO,
    President	 
	 	 	 	 
	 	Date:
    	7/6/2020	 

 

Roswell
Park Cancer Institute Corporation d/b/a Roswell Park Comprehensive Cancer Center

 

	 	Name:	s/Michael
    B. Sexton, Esq.	 
	 	 	 	 
	 	Title:
    	Chief
    Administration Officer and General Counsel	 
	 	 	 	 
	 	Date:
    	June
    24, 2020	 

 

Read
and Acknowledged as Payee:

Health
Research Inc., Roswell Park Division

 

	 	Name:	s/John
    Blandino	 
	 	 	 	 
	 	Title:
    	Director
    of Health Research, Inc.	 
	 	 	Roswell
    Park Division	 
	 	Date:
    	7/3/2020	 

 

    	 	-12-

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