2/2/2021

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

EX-10.4 5 ex10-4.htm
EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBITTHAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND(II) WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.
EXHIBIT 10.4
CLINICAL TRIAL AGREEMENTTHIS 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 hereinas 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;” andWHEREAS, AIM is providing Rintatolimod, also known as Ampligen® (“Study Drug”), information, and funding toInstitution 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 clinicalresearch 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; andWHEREAS, 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 byreference 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 theInstitution’s Institutional Review Board or another designated Institutional Review Board (“IRB”). Institution will provide AIM withthe final Protocol, which shall be considered Confidential Information pursuant to section 8 of this Agreement before commencementof the Study. Thereafter, the Protocol may be amended only following consultation with AIM and consent of the Institution andsubsequent approval by the IRB.
-1-

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

1/12

2/2/2021

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBITTHAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND(II) WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.
2. Conduct of Studya.

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 (“ApplicableLaws”). 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 andInstitution agree that errant information posted on clinicaltrial.gov website regarding this Study, Institution will submit andrequest 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 andtemplate 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 arecompetent 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 shallnot 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: casereport 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 clinicalobservations 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 initialcohort before implementing the combination cohorts. For the avoidance of doubt, such communication shall be treatedas Confidential Information, ( as defined below) by the Parties-2-

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

2/12

2/2/2021

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBITTHAT 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:
●
●
●

x.

an individual who has been debarred by the FDA pursuant to 21 U.S.C. §335a(a) or (b) from providing services inany 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; ora 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; oran individual or corporation, partnership, or association that has been barred from participation in a Federal HealthCare Program (as defined in 42 U.S.C. § 1320a (7b (f)), as amended from time to time or in any other governmental
payment program.

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.
b.
c.

d.
e.

AIM will furnish an agreed upon number of vials of Study Drug, approximately *** vials, *** to the Institution pursuant tothis Agreement solely for use in the Protocol. ***Institution will store, handle and administer Study Drug under adequately controlled conditions and in accordance with theProtocol, and Study Drug information provided by AIM.
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 madeavailable by the Institution to any other party for any other purpose, without the written consent of AIM, which writtenconsent shall not be unreasonably withheld.
Institution will not bill any Study subject or any third parties for any service or activity that is funded in accordance with thisAgreement or any Study Drug that is supplied by AIM under this Agreement.
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 norepresentation and provides no ‘warranty that the use of the Study Drug in the Study will not infringe any patent or otherproprietary right of third parties.
-3-

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

3/12

2/2/2021

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBITTHAT 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 theInstitution’s behalf will comply with all applicable federal and New York state laws and regulations governing privacy andconfidentiality of health information, including without limitation, the Health Insurance Portability and Accountability Act of1996 and implementing regulations (“HIPAA”), as well as confidentiality agreements entered into by the Parties.
5. Adverse Eventsa.

Adverse Events. Institution will ensure that its personnel comply with notification procedures provided in the Protocol andApplicable 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 thewritten 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 toother 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 shallprovide IND Safety Reports to AIM at the time of report to FDA or as soon as possible thereafter, according to FDA Reportingtime 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 Investigatora.

Term. This Agreement shall commence on the Effective Date and shall continue until the completion of the Study or suchother date as may be agreed to by the Parties (“Term”).
-4-

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

4/12

2/2/2021

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBITTHAT 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 expirationof 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 orother 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 disbarrediv. 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 ofthis 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 theduties 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 Informationa.

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 notpatentable) identified in writing as “Confidential.” In addition, Confidential Information includes, but is not limited toclinical data expressly required to be collected by the Study Protocol or pursuant to the terms of this Agreement, theInvestigational 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-

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

5/12

2/2/2021

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBITTHAT 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 discloseor 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 aneed-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 suchinformation: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; oriv. is independently developed by receiving personnel without reliance on Confidential Information, as shown byprior written recordsd.

Allowable Disclosures. Confidential information may be disclosed to the extent it is required by Applicable Laws to bedisclosed 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 thedisclosure 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 theexpiration 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 thisAgreement 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-

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

6/12

2/2/2021

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBITTHAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND(II) WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.
9. Publication
a,
b.

c.

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.
Scientific Publications should be published in a timely manner, in accordance with industry standards, and present scientificinformation in an accurate and balanced way that does not exclude or inappropriately downplay negative safety or healthinformation. Authorship related to Scientific Publications shall be determined in accordance with and governed by thecriteria defined by the International Committee of Medical Journal Editors (ICMJE) Recommendations for the Conduct,
Reporting, Editing, and Publication of Scholarly Work in Medical Journals.
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 patentablesubject 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 appropriatescientific 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 Propertya.

Pre-existing Property. Institution understands and acknowledges that the Study Drug, Ampligen® (rintatolimod) is theproperty 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 executionof this Agreement (“Pre-existing Property”) shall remain the separate property of that party and nothing contained in thisAgreement 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-

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

7/12

2/2/2021

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBITTHAT 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 otherintellectual property arising from the performance of the Protocol (hereinafter “Other Inventions”) shall be determined by theapplication of U.S. patent laws.

11. Audits and Inspectionsa.

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 meetingor 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 suchrecords. Information regarding Institution’s systems, the information therein, and any incidental information that would beunderstood by a reasonable professional in the field to be confidential shall remain the property of Institution and will betreated 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 orlaw. No news release, publicity or other public announcement, either written or oral, regarding this Agreement or performancehereunder 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 theStudy 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 tobe 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-

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

8/12

2/2/2021

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBITTHAT 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 thisAgreement shall be valid unless reduced to writing and signed by the Parties. Any requests for changes or amendments or othernotices 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 thefollowing:
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 accordancewith 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 tomaintain the integrity of the Study as required by the Protocol. Reports shall be considered Confidential Information and shallnot be disclosed for any public dissemination without Institution’s prior written consent.
-9-

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

9/12

2/2/2021

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBITTHAT 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 fordisclosure 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 besubmitted without Institution’s consent by AIM to the FDA (or other regulatory agency or governmental authority) for purposesof Emergency Approval, Orphan Drug Status, Fast Track Status and New Drug Approval consideration upon receipt due to theurgency 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, EffectThis Agreement shall be binding upon the Parties, their legal representatives, successors, and assigns. The obligations of theParties 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 orrelinquishment 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-

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

10/12

2/2/2021

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBITTHAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND(II) WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.
21. Force Majeure21.1 Non-fulfillment, delay or omission by any of the Parties as regards of any and all of the obligations imposed by thisAgreement 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, suchas labor disputes, fire, mobilization, public health emergencies, insurrection, war, natural disasters, the prohibition of agovernment 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 thisAgreement. 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 adocument 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 thanninety (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 thesituation, 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, theParty affected by the non-fulfillment may request the termination of the Agreement, and must be accepted by the other Party andwill 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 suchright or remedy deriving from it.
-11-https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

11/12

2/2/2021

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBITTHAT 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 thisAgreement, 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-

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-4.htm

12/12