Document:

Clinical Trial Agreement

 

CLINICAL
TRIAL AGREEMENT

 

THIS
AGREEMENT (“Agreement”), made as of October 9, 2018 (the “Effective Date”), by and between ROSWELL
PARK CANCER INSTITUTE CORPORATION (“Institution”), a New York State public benefit corporation, with its principal
office located at Elm and Carlton Streets, Buffalo, NY 14263 and employer of Pawel Kalinski, MD (“Principal Investigator”),
and HEMISPHERX BIOPHARMA, INC. a corporation organized under the laws of Delaware, having an office at 2117 SW Highway 484, Ocala,
FL 34473 (hereinafter “Hemispherx”).

 

WITNESSETH:

 

WHEREAS,
Institution is a National Cancer Institute-designated Comprehensive Cancer Center and conducts clinical research studies; and

 

WHEREAS,
Hemispherx is a pharmaceutical company in the business of developing certain drugs including natural immune system enhancing technologies;

 

WHEREAS,
Institution is conducting a clinical study pursuant to a protocol entitled “A Phase IIa Study of Cytokine Modulation (CKM)
Regime in Combination with Checkpoint Inhibitors in Patients with Primary Resistance to Checkpoint Inhibitor Therapy” (the
“Protocol”) involving up to 100 subjects in bladder carcinoma, renal cell carcinoma and melanoma (the “Study”);

 

WHEREAS,
Institution has reviewed sufficient information regarding Hemispherx’s product, Ampligen€ (rintatolimod) (the “Study
Drug”), and desires to sponsor a clinical study involving the use of the Study Drug as more fully detailed herein; 

 

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. Protocol 

 

a.
Institution Sponsor. Institution and/or Principal Investigator have developed the Protocol, which details the clinical
research activities, instructions and responsibilities for the Study. Hemispherx will review the Protocol in order to ensure the
Protocol is consistent with Hemispherx’ instructions for receiving, storing, and using the Study Drug. This Agreement and
the effectiveness of the Protocol are contingent on the Institution successfully obtaining Institution’s Institutional Review
Board (“IRB”) approval as applicable to the scope of the Study including compliance with all Institution human subject
policies, as well as any required Food and Drug Administration (FDA) and/or other regulatory approvals for the conduct of the
Study (“Conditions Precedent”). Institution shall provide to Hemispherx written documentation of MB and FDA approval
of the Study including a copy of the MB approved Clinical Trial Agreement consent form and a signed 1572 form for each study site.
Hemispherx understands that the IRB may approve the Protocol subject to conditions or other requirements that would result in
amendment to the Protocol. Institution shall have the right, in its sole discretion, to reject the IRB’s conditions or other
requirements and to terminate this Agreement upon thirty (30) days prior written notice of such rejection to Hemispherx. Upon
final agreement of the parties with respect to the Study, and IRB and FDA approvals of the Protocol, the Protocol and any subsequent
duly approved amendments thereto shall be incorporated by reference as Exhibit A to this Agreement.

 

2.
Conduct of the Study

 

a.
Standards of Performance. Institution will use reasonable efforts to perform the Study in accordance with: the Protocol;
all applicable laws, rules, regulations, and guidelines relating to the conduct of clinical studies including the applicable standards
of good clinical practices (“Applicable Laws”); and generally accepted standards of professional medical practice.

 

b.
Study Team. Institution may appoint sub-investigators and other personnel as it may deem appropriate to assist in the
conduct of the Study (“Study Personnel”). 

 

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c.
Subsites. Institution intends to subcontract with third party clinical subsites to participate in the conduct of the
Study (“Subsites”).

 

d.
Provision of Study Drug. Hemispherx shall provide to Institution and Subsites, at Hemispherx’s sole expense, quantities
of the Study Drug sufficient for the conduct of the Study in accordance with the Protocol. Hemispherx shall, at its sole expense,
ship the Study Drug to Institution and any Subsite designated by Institution at the address(es) to be provided under separate
cover.

 

3.
Representations. Institution represents that:

 

a.
Principal Investigator is qualified by training and experience with appropriate expertise to conduct the Study;

 

b.
Study Personnel have all credentials necessary to safely, adequately, and lawfully perform the Study; and

 

c.
It, Principal Investigator, and Study Personnel, as applicable, is/are not:

 

		i.	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
	 	 	 
		ii.	a
                                         corporation, partnership, or association that has been debarred by the FDA pursuant to
                                         21 U.S.C. § 335a (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 
	 	 	 
		iii.	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. 

 

4.
Study Drug

 

	a.	Hemispherx
                                         will furnish Study Drug for the Study pursuant to this Agreement solely for use in the
                                         performance of the Protocol.
	 	 
	b.	Institution
                                         will receive, store, prepare, and administer the Study Drug consistent with institutional
                                         guidelines for handling of the Study Drug, the Protocol and Hemispherx documents entitled
                                         “Procedures for receiving, storing and using Ampligen° (rintatolimod) (Poly
                                         I: Poly C12U) liquid solution”, and “The Clinical Investigator’s
                                         Brochure — Rintatolimod — Trade name Ampligen® (Poly I : Poly
                                         C12U)” (together the “Hemispherx Instructions”). In the
                                         event of inconsistency between the Hemispherx Instructions and the Protocol, the instructions
                                         in the Protocol shall prevail.
	 	 
	c.	Institution
                                         will destroy Study Drug in accordance with Institution’s drug destruction policies.
                                         Hemispherx’ approval will be required prior to destruction of any Ampligen®.
                                         Written documentation of any Ampligen° destruction, including number of vials, will
                                         be sent to Hemispherx.
	 	 
	d.	Institution
                                         will not bill any Study Subject or any third parties for Study Drug that is supplied
                                         by Hemispherx under this Agreement.
	 	 
	e.	Hemispherx
                                         represents and warrants that: the Study Drug, and Institution’s use thereof, does
                                         not infringe on any third party’s rights, including intellectual property rights;
                                         the Study Drug has been prepared/manufactured in accordance with all applicable regulatory
                                         requirements and good manufacturing practices; and Hemispherx has advised Institution
                                         of any and all known contraindications and/or known side effects for the use of the Study
                                         Drug. If Hemispherx at any time becomes aware of additional actual or possible contraindications
                                         and/or side effects of the Study Drug, Hemispherx will promptly notify Institution of
                                         all such information. 

 

5.
Privacy Laws

 

	a.	Institution
                                         will ensure that Principal Investigator and Study Personnel will comply with all applicable
                                         federal and 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”). 
	 	 
	b.	Hemispherx
                                         acknowledges that Institution is a patient care facility and, as such, has a legal and
                                         regulatory obligation to protect and secure patient care information. Hemispherx
                                         hereby agrees to comply with Institution’s security policies and procedures relating
                                         to third-party access to patient information and records. In the event Hemispherx comes
                                         into contact or otherwise has access to a Study Subject’s identifiable information,
                                         then Hemispherx shall ensure such information and the identity of the Study Subject is
                                         held in confidence and treated in accordance with Institution’s instructions and
                                         all applicable laws and regulations. Hemispheric shall not attempt to identify or contact
                                         any Study Subject. 

 

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6.
Adverse Events and Study Subject Injury 

 

	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 event of
                                         the occurrence of serious adverse events. Each original serious adverse event report
                                         and each report of a pregnancy in a female subject participating in the Study must be
                                         communicated to the IRB and to Hemispherx within 24 hours of the first investigator knowledge
                                         of the serious adverse event or pregnancy, or as set forth in the Protocol. Any follow-up
                                         reports to the IRB regarding serious adverse events or pregnancy in a Study subject must
                                         be copied to Hemispherx. 
	 	 
	b.	Safety
                                         Monitoring Reporting. Hemispherx shall notify Institution promptly and in writing
                                         of any information that could affect the safety of subjects or their willingness
                                         to continue participation, influence the conduct of the Study, or alter the IRB’s
                                         approval to continue the Study. Hemispheric shall communicate results of studies to Institution
                                         and Principal Investigator that may directly affect the Study subject’s safety
                                         or medical care, Institution, through its Principal Investigator and/or IRB, as appropriate,
                                         will inform Study subjects of additional information in accordance with IRB direction.
                                         
	 	 
	c.	Adverse
                                         Long-Term Results. Hemispherx will notify Institution promptly in the event that
                                         adverse long-term results that may be discovered after conclusion of the Study show
                                         the health of Subjects in the Study may be adversely affected because of Study participation.
                                         Institution will review results provided by Hemispherx and, through its IRB, will determine
                                         whether and how to disseminate information to Study subjects.
	 	 
	d.	Study
                                         Subject Injury. Hemispherx agrees that it, and not Institution, is responsible and
                                         shall reimburse Institution for the costs of diagnosis, care and treatment of any
                                         undesirable side effects, adverse reactions, illness or injury to a participant in the
                                         Study which, in the reasonable judgment of the Principal Investigator or Institution,
                                         definitely resulted from the Study Drug, Ampligen®, except for such costs that arise
                                         directly from the reckless or intentional misconduct of Institution, Principal Investigator
                                         or Study Personnel. 

 

7.
Term and Termination

 

	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, unless
                                         otherwise terminated in accordance with this Agreement (“Term”). The parties
                                         agree that no work shall begin until all Conditions Precedent are fully met. 
	 	 
	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 the emergency of any adverse event with
                                         the Study Drug or any other product(s) administered in the Study is of such magnitude
                                         or incidence in the reasonable and good faith opinion of Principal Investigator, Institution,
                                         and/or Hemispherx to support termination.
	 	 	 
		iii.	Upon
                                         written mutual agreement. 

 

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. 

 

8.
Confidential Information

 

	a.	Definition.
                                         “Confidential Information” will mean the terms and conditions of this
                                         Agreement and all information or data provided by one party to another related to the
                                         Study that is marked as confidential or that a reasonable person knowledgeable in the
                                         field would recognize as confidential or proprietary. 

 

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	b.	Obligations.
                                         Each party shall maintain in strict confidence all of the other party’s Confidential
                                         Information and not disclose or disseminate such Confidential Information to any third
                                         party or use such Confidential Information for any purpose other than the performance
                                         of or monitoring 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 who has a right to make such disclosure
                                         in a non-confidential manner; 
	 	 	 
		iii.	is
                                         already known to receiving party prior to disclosure hereunder, as shown by prior written
                                         records; or
	 	 	 
		iv.	is
                                         independently developed by receiving party without reliance on or incorporation of the
                                         disclosing party’s Confidential Information. 

 

	d.	Disclosure
                                         Required by Law. Confidential Information may be disclosed to the extent it is required
                                         by law or court order or other governmental order, 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. The parties acknowledge and agree that any violation of the terms of this
                                         Agreement relating to the disclosure or use of Confidential Information will result in
                                         irreparable injury and damage to disclosing party not adequately compensable in money
                                         damages, and for which the disclosing party may have no adequate remedy at law. The receiving
                                         party acknowledges and agrees that if those disclosure terms are violated, then the disclosing
                                         party has a right to obtain 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 five (5) 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 Termination section, all Confidential Information that
                                         was furnished under this Agreement will be returned or destroyed at the direction of
                                         the disclosing party, except for record copies that the non-disclosing 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 such party’s 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, including without limitation,
                                         proprietary information and materials (whether or not patentable) identified in writing
                                         as “Confidential.”

 

9.
Publication

 

Notwithstanding
any other provision of this Agreement to the contrary, Institution and Principal Investigator may present or publish the results
of the Study, after an opportunity for review and comment by Hemispherx, Institution will submit to Hemispherx material intended
for publication, including abstracts and presentation materials (collectively, “Proposed Publication”) at least thirty
(30) days prior to submitting to a publisher or other outside persons. If Hemispherx reasonably believes that any Proposed Publication
contains information relating to a patentable invention, Institution shall delay the disclosure of such Proposed Publication for
an additional thirty (30) days to permit Hemispherx to file patent applications. If any Proposed Publication contains Hemispherx
Confidential Information, Hemispherx shall have the right to require that Institution delete any reference to Hemispherx Confidential
Information, excluding the results of the Study. Nothing herein affords Hemispherx editorial rights with respect to the Proposed
Disclosure.

 

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10.
Intellectual Property

 

	a.	Pre-existing
                                         Property. Institution understands and acknowledges that the Study Drug, Ampligen®
                                         (rintatolimod) is the property of Hemispherx and/or that it may be subject to certain
                                         intellectual property rights owned by or licensed to Hemispherx. All rights to Ampligen®
                                         (rintatolimod) belong to Hemispherx. 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 or other proprietary interests to Pre-existing
                                         Property of the other party. 
	 	 
	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 governed by the following
                                         provisions: Other Inventions made solely by the Principal Investigator or employees of
                                         Institution shall be the property of Institution (hereinafter “Institution Inventions”);
                                         Other Inventions made jointly by employees or agents of Hemispherx and Institution shall
                                         be the joint property of Hemispherx and Institution (hereinafter “Joint Inventions”).
                                         Inventorship of Other Inventions conceived or reduced to practice in the course of performing
                                         the Study shall be determined by the application of U.S. patent laws. 

 

11.
Indemnification 

 

	a.	Indemnification
                                         by Hemispherx. Hemispherx shall defend, indemnify, and hold harmless Principal Investigator,
                                         Institution, IRB, and/or its or their officers, directors, employees, consultants, agents
                                         and independent contractors (hereinafter “Institution Indemnitees”) from
                                         and against any and all demands, claims, actions, suits, losses, damages, costs, and
                                         expenses (including reasonable attorneys’ fees and court costs), alleged to be
                                         caused by or arising from: (1) the use of the Study Drug; (2) negligence, willful misconduct,
                                         or breach of this Agreement by Hemispherx regardless of the legal theory asserted; or
                                         (3) any claim that the use of the Study Drug in the Study infringes the proprietary rights
                                         of a third party. Hemispherx shall have no obligation to provide such indemnification
                                         to the extent that such Claim is directly caused by Institution lndemnitees’ negligence,
                                         gross negligence or willful misconduct. 
	 	 
	b.	Indemnification
                                         by Institution. To the extent permitted by law, Institution shall defend, indemnify
                                         and hold harmless Hemispherx and its respective officers, directors, employees, and its
                                         successors or permitted assigns (“Hemispherx Indemnitees”) from and against
                                         any and all liability, loss, damage or expense (including reasonable attorneys’
                                         fees and expenses of litigation) incurred by or imposed upon Hemispherx Indemnitees in
                                         connection with any third party claims to the extent such claims are directly attributable
                                         to: (i) Institution Indemnitees’ negligent activities, reckless misconduct, intentional
                                         misconduct or omissions; or (ii) failure of the Institution Indemnitees to comply with
                                         Applicable Laws. Institution shall have no obligation to provide such indemnification
                                         to the extent that such Claim is directly caused by Hemispherx Indemnitees’ negligence,
                                         gross negligence or willful misconduct. 
	 	 
	c.	Notice.
                                         The party seeking indemnification will promptly notify the other party of any actual
                                         or prospective claim for which indemnification is sought, provided, however, that failure
                                         to give such notice shall not relieve the indemnifying party of its obligations under
                                         this Section except to the extent that the indemnifying party is materially prejudiced
                                         by such failure. 
	 	 
	d.	Defense.
                                         In the event that any third-party claim is made, the indemnifying party shall undertake
                                         and control the defense using qualified counsel with demonstrable experience defending
                                         claims of the type to be defended and approved by the indemnified party, which approval
                                         shall not be unreasonably withheld.
	e.	No
                                         Settlement without Consent. Under no circumstances shall the party seeking indemnification
                                         pursuant to this Section compromise, settle or otherwise admit any liability with respect
                                         to any Claim without the prior written consent of the party providing indemnification,
                                         which consent shall not be unreasonably withheld.

 

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12.
Use of Names

 

Hemispherx
and Institution shall not disclose publicly the terms of this Agreement, except to the extent required by academic policies or
law including legally required disclosure of the existence of the Agreement. No party to this Agreement shall use the name of
any other party hereto in connection with any advertising or promotion of any product or service without the prior written permission
of such party, as appropriate except that: Hemispherx may publically disclose its contribution of Study Drug, and identify Institution
as the primary Study site and Principal Investigator as the Institution employee having primary responsibility for conduct of
the Study; and Institution may disclose the title of the Study, the supply of Study Drug and the identity of Hemispherx in order
to complete grant applications or to fulfill internal reporting requirements. Institution acknowledges and understands that Hemispherx,
being a public company, is required by law to publicly disclose certain information and agrees that Hemispherx may publically
disclose such information to the extent necessary to comply with such applicable laws. Notwithstanding anything in this Paragraph
to the contrary, all Hemispherx press releases, public announcements or similar public disclosures related to this Agreement shall
be provided to Institution at least three (3) business days prior to release and Hemispherx shall consider, in good faith, any
of Institution’s requests for revision to the disclosure prior to publication. In no event may Hemispherx disclose Institution’s
Confidential Information without Institution’s express written consent. 

 

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. 

 

14.
Complete Agreement, Amendment

 

The
parties agree that this Agreement constitutes the sole, full, and complete Agreement by and between the parties concerning the
Study 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. In the event of a conflict between the Protocol and this Agreement,
the terms of this Agreement shall govern, except in the case of matters relating to clinical procedures, with respect to which
the terms of the Protocol shall prevail. 

 

15.
Notice

 

Any
notice required and/or permitted to be given under this Agreement must: (i) be given in writing; (ii) be delivered either personally
(by hand delivery), by certified mail (postage prepaid, return receipt requested), express mail, by a commercial overnight courier,
or transmitted by facsimile; and (iii) be addressed as follows: 

 

	If to
    Roswell Park:	 	If to
    Hemispherx:
	 	 	 
	Roswell Park Cancer Institute Corporation	 	Hemispherx Biopharma Inc.
	Elm and Carlton Streets	 	2117 SW Highway 484
	Buffalo, NY 14263	 	Ocala, FL 34473
	Attention: Camille Wicher, VP, Clinical	 	Attention: Thomas Equels, CEO
	Research Services	 	 

 

	With a copy to:	 	With a copy to:
	Office of General Counsel (same address)	 	Peter Rodino, Esq., General Counsel
	Pawel Kalinski, MO (same address)	 	(at same address)

 

Any
such notice shall be deemed to have been received on (i) the day such notice is personally delivered, (ii) three (3) days after
such notice is mailed by prepaid certified or registered mail, (iii) one (1) business day after such notice is sent by overnight
courier, or (iv) the day such notice or communication is faxed provided the sender has received a confirmation of such fax. 

 

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16.
Binding Effect

 

This
Agreement shall be binding upon the parties, their legal representatives, successors, and permitted assigns. The obligations of
the parties contained in Sections 6 (Adverse Events and Subject Injury), 8 (Confidential Information), 9 (Publication), 10
(Intellectual Property), 11 (Indemnification), and18 (Insurance) shall survive the termination or expiration of this Agreement.

 

17.
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. 

 

18.
Insurance

 

Each
party shall maintain a program of self-insurance and/or liability insurance in the type and amount appropriate and customary for
the undertaking of the obligations hereunder, and, upon request, will provide the other party a certificate of insurance evidencing
such insurance. 

 

19.
Assignment 

 

Neither
Party shall assign or transfer any rights, obligations or duties under this Agreement without the prior written consent of the
other party. 

 

20.
Force Majeure

 

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,
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. 

 

21.
Authority 

 

Each
of the parties hereto represents and warrants 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. 

 

22.
Governing Law and Jurisdiction

 

This
Agreement shall be governed and interpreted in accordance with the laws of the State of New York without regard to conflicts of
laws principles. The Parties agree that any claim or controversy arising out of or relating to this Agreement or any breach hereof
shall be exclusively submitted to a court of competent jurisdiction in the State of New York, and each Party hereby irrevocably
consents to the exclusive jurisdiction and venue of such court. 

 

23.
Counterparts and Electronic Signatures

 

This
Agreement may be executed in counterparts, each of which shall be deemed an original but all of which together shall constitute
one and the same binding Agreement. The parties agree to accept a signed facsimile or portable document format (.pdf) copy of
this Agreement as a fully biding original. 

 

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

 

	Hemispherx Biopharma, Inc.	 	Roswell Park Cancer Institute Corporation

	 	 	 	 	 
	By:	/s/
    Thomas K. Equels	 	By:	/s/
    Michael B. Sexton
	Name: 	Thomas
    K. Equels	 	Name:	Michael
        B. Sexton, Esq.

        

	Title:	Chief
    Executive Officer	 	Title:	Chief
    Administrative Officer and General Counsel
	 	 	 	 	 
	Date: 10/9/2018	 	Date: 10/9/2018
	 	 	 	 	 
	READ AND ACKNOWLEDGED BY:	 	 	 
	 	 	 	 	 
	Principal Investigator	 	Health Research, Inc., Roswell Park Division as payment assignee
	 	 	 
	By:	/s/
    Pawel Kalinski	 	By:	/s/
    John Blandino
	Name: 	Pawel
    Kalinski,	 	Name:	John
    Blandino
	Title:	Vice
Chair for Translational Research	 	Title:	Director
	 	 	 	 	 
	Date: 10/5/2018	 	Date: 10/9/2018

 

    	Confidential	 	Page 8 of 8FIRST
AMENDMENT TO PURCHASE AND SALE AGREEMENT

 

THIS
FIRST AMENDMENT TO PURCHASE AND SALE AGREEMENT (“Amendment”) is made as of this __ day of March, 2018,
by and between HEMISPHERX BIOPHARMA, INC., a Delaware corporation (the “Seller”), and 783 JERSEY
AVENUE, LLC, a New Jersey limited liability company, successor-by-assignment to Capital Realty & Investment Co., LLC (the
“Purchaser”).

 

WITNESSETH:

 

WHEREAS,
Seller and Purchaser entered into a Purchase and Sale Agreement dated as of January 8, 2018 (the “Original Agreement”)
with respect to the “Property” defined therein located at 783 Jersey Avenue, New Brunswick, New Jersey; and

 

WHEREAS,
Seller and Purchaser have agreed to amend the Original Agreement as set forth in this Amendment.

 

NOW,
THEREFORE, In consideration of the mutual covenants and agreements set forth herein, for valuable consideration, the receipt of
which is hereby acknowledged, the parties hereto do hereby agree as follows:

 

ARTICLE
I. definitions

 

All
capitalized terms not defined in this Amendment shall have the meanings ascribed to them in the Original Agreement. All references
to the “Agreement” contained in this Amendment and in the Original Agreement shall hereafter be deemed to refer to
the Original Agreement, as modified and amended by this Amendment. The Recitals above shall be a part of this Amendment, and are
incorporated by reference.

 

ARTICLE
II. Amendment of original agreement

 

	2.1	Purchase
    Price. Section 2.1 of the Original Agreement is hereby modified to increase the Purchase Price to FOUR MILLION
    EIGHTY THOUSAND AND 00/100 DOLLARS ($4,080,000.00).
	 	 
	2.2	Inventory
    of Personal Property. Exhibit B-1 attached to the Original Agreement is hereby replaced with Exhibit
    B-1 attached to this Amendment.
	 	 
	2.3	Seller
    Lease. Exhibit B-3 attached to the Original Agreement is hereby replaced with Exhibit B-3
    attached to this Amendment.

 

    	-1-

    	 

    

 

ARTICLE
III. MISCELLANEOUS

 

	3.1	Other
    Provisions Unaffected. Except as modified hereby, all other provisions of the Original Agreement shall remain in in full
    force and effect, unmodified by this Amendment, and are hereby fully ratified, confirmed and adopted by Purchaser and Seller.
	 	 
	3.2	Entire
    Agreement. The Original Agreement, as modified by this Amendment, together with the Exhibits hereto, constitutes the entire
    understanding between the parties with respect to the Transaction and all prior agreements, understandings, representations
    and statements, oral or written, are merged into this Amendment.
	 	 
	3.3	Governing
    Law. This Amendment shall be governed by, and construed in accordance with, the law of the State of New Jersey.
	 	 
	3.4	Severability.
    If any term or provision of this Amendment or the application thereof to any persons or circumstances shall, to any extent,
    be invalid or unenforceable, the remainder of this Amendment or the application of such term or provision to persons or circumstances
    other than those as to which it is held invalid or unenforceable shall not be affected thereby, and each term and provision
    of this Amendment shall be valid and enforced to the fullest extent permitted by Law.
	 	 
	3.5	Counterparts.
    This Amendment may be executed in counterparts, each of which shall be an original and all of which counterparts taken together
    shall constitute one and the same agreement. Any executed counterpart delivered by electronic mail or telephone facsimile
    shall have the same force and effect as an original counterpart.

 

[REMAINDER
OF THIS PAGE LEFT INTENTIONALLY BLANK]

 

    	-2-

    	 

    

 

IN
WITNESS WHEREOF, each party hereto has caused this Amendment to be duly executed on its behalf on the day and year first
above written.

 

	 	SELLER:
	 	 	 
	 	HEMISPHERX
    BIOPHARMA, INC. A Delaware corporation
	 	 	 
	 	By:	/s/
    Wayne Springate
	 	Name:
    	Wayne
    Springate
	 	Title:
    	Sr.
    VP     of Operations
	 	 	 
	 	PURCHASER:
	 	 	 
	 	783
    JERSEY AVENUE, LLC, a New Jersey limited liability
	 	 	 
	 	By:	Kerron,
    LLC, a New Jersey limited liability company, an authorized manager
	 	 	 
	 	By:	/s/
    Aaron T. Feiler
	 	Name:
    	Aaron
    T. Feiler
	 	Title:
    	Member

 

    	-3-

    	 

    

 

EXHIBIT
B-1

 

INVENTORY
OF PERSONAL PROPERTY

 

	RM#
    129	Equipment
    Description
	HB#
    2222	Thermo
    Electron -70C Freezer
	HB#2051	Forma
    Scientific -70C Freezer
	HB#
    2262	Thermo
    Electron -70C Freezer
	HB#2294	Thermo
    Electron -70C Freezer
	HB#2261	Thermo
    Electron -70C Freezer
	HB#2223	Thermo
    Electron -70C Freezer
	HB#
    2245	Leer
    -20C Walk In Freezer
	HB#3256	VWR
    Symphony -70C Freezer
	HB#
    3346	Whirlpool
    -20C Freezer
	HB#
    3255	VWR
    Symphony -70C Freezer
	HB#
    2334	Dometic
    -70C Freezer
	HB#
    3341	Thermo
    Scientific -70C Freezer
	HB#
    3005	Darwin
    Stability Refrigerator
	HB#
    3340	Thermo
    Scientific -70C Freezer
	HB#
    2265	Thermo
    Electron -70C Freezer
	HB#
    1995	Magic
    Chef -20C Freezer
	HB#
    2333	Dometic
    -70C Freezer
	HB#
    2244	Leer
    -20C Walk In Freezer
	HB#
    3006	VWR
    Humidity Stability Chamber
	HB#2335	Dometic
    -70C Freezer
	 	 
	RM
    #330	Equipment
    Description
	HB#
    1958	Forma
    Scientific Dry Incubator
	HB#
    3148	Thermo
    Scientific Dry Incubator
	HB#
    3149	Thermo
    Scientific Dry Incubator
	HB#
    1666	SterilGARD
    Biological Safety Cabinet
	HB#
    1789	SterilGARD
    Biological Safety Cabinet
	HB#
    1278	Quebec
    Colony Counter
	HB#
    1997	Met
    One Particle Counter
	HB#
    1779	RCS
    Air Sampler
	HB#
    1260	Leitz
    Microscope
	 	 
	RM#325	Equipment
    Description
	HB#
    2221	Thermo
    Electron -70C Freezer
	HB#
    1883	Gibson
    -20C Freezer
	HB#
    2214 (Top & Bottom)	Forma
    Scientific Water Jacketed CO2 Incubator
	HB#
    3151/ HB#3150	Thermo
    Scientific Water Jacketed CO2 Incubator
	HB#
    2231	Mettler
    Toledo pH meter
	HB#3207	Thermo
    Scientific UV Spectrophotometer
	HB#
    3363	Fisher
    Scientific Dry Incubator
	HB#2186	Mettler
    PM 200 Balance

 

    	B1-1

    	 

    

 

	RM
    323	Equipment
    Description
	HB#
    2343	SterilGARD
    Biological Safety Cabinet
	HB#
    2344	SterilGARD
    Biological Safety Cabinet
	HB#
    2282	VWR
    Waterbath
	HB#3174	VWR
    Waterbath
	HB#1204	Wild
    M40 Microscope
	N/A	DELL
    Computer for CPE Calculations
	HB#
    3283	TRUE
    Refrigerator
	HB#
    3296	TRUE
    Refrigerator
	HB#
    3168	Fisher
    Depyrogenation Oven
	HB#
    3362	Kenmore
    Freezer
	 	 
	RM
    327	Equipment
    Description
	HB#
    1131	Forma
    Quick Glassware Dryer
	HB#
    2306	Primus
    Sterilizer
	HB#
    2300	Miele
    Professional Laboratory Equipment Washer
	 	 
	RM#
    322	Equipment
    Description
	HB#
    2330	Tecan
    Plate Reader
	HB#
    1101	Mettler
    Toledo Balance
	Computer
    #55	DELL
    Computer for Tecan Plate Reader
	HB#
    1228	Bellco
    Glass Biological Safety Cabinet
	HB#
    3325	Nuaire
    Biological Safety Cabinet
	HB#
    1289	Bausch
    & Lomb Microscope
	HB#
    1127	Beckman
    Centrifuge
	HB#
    1631	Titertek
    Plate Reader
	HB#
    3001	Chromate
    Plate Reader
	HB#
    3404	Plate
    Gyratory Shaker
	Computer
    # 54	DELL
    Computer for CPE Calculation
	 	 
	RM#324	Equipment
    Description
	HB#
    3054	VWR
    Waterbath
	HB#
    1269	Diavert
    Microscope
	HB#
    1205	BioGARD
    Biological Safety Cabinet
	HB#
    3262/ 3263	Forma
    Scientific Water Jacketed CO2 Incubator
	HB#
    3291	SANYO
    Water Jacketed CO2 Incubator
	HB#1255	Bransonic
    Sonicator
	 	 
	RM#310
    (SSI)	Equipment
    Description
	HB#
    2353	Millipore
    Filter Integrity Tester
	HB#
    2354	Guava
    Cell counter
	HB#
    2251	Mettler
    Toledo Balance
	HB#
    3154	Fisher
    Scientific IsoTemp Water Bath
	HB#
    2345	SterilGARD
    Biological Safety Cabinet
	HB#
    1646	Sorvall
    Centrifuge
	HB#
    1677	Waterbath

 

    	B1-2

    	 

    

 

	RM
    #226	Equipment
    Description
	HB#
    3349	Sievers
    M-9 TOC Analyzer
	Computer
    #53	DELL
    Computer for TOC Analyzer
	HB#
    3232	Mettler
    Toledo Conductivity Meter
	HB#3332	Mettler
    Toledo Conductivity Meter
	HB#
    2104	Fisher
    Scientific Oven
	HB#
    3098	Desiccator
	HB#
    2347	Glas-Col
    Heating Mantle
	HB#
    2346	Maflar
    Furnace
	HB#
    1498	Sartorius
    Balance
	HB#
    1502	UV-160
    Shimadzu UV Spectrophotometer
	HB#
    1776	Perkin
    Elmer 1420 Infrared Spectrophotometer
	HB#
    1589	Fume
    Hood
	 	 
	RM#
    225	Equipment
    Description
	HB#2359	Agilent
    HPLC
	HB#
    1824	RCA
    Refrigerator
	HB#
    2172	Agilent
    HPLC
	HB#
    3008	Agilent
    GC
	HB#
    3372	Advance
    Osmometer
	Computer
    #47	DELL
    Computer for HPLC & GC
	HB#1888	Savant
    Speed Vac
	 	 
	RM#218	Equipment
    Description
	HB#
    2212	Bally
    Walk In Refrigerator
	HB#
    1919	Frigidaire
    -20C Freezer
	HB#3369	Eppendorf
    Centrifuge
	HB#
    2215	Edge
    Gard Hood
	HB#
    2216	Edge
    Gard Hood
	HB#
    2274	Denver
    Conductivity Meter
	HB#
    1518	Shimadzu
    Densitometer
	HB#
    2283	Brookfield
    Viscometer
	HB#
    2291	JASCO
    CD Spectrophotometer
	HB#
    2289	Mettler
    Toledo pH meter
	HB#
    3146	VWR
    Viscometer (waterbath)
	HB#
    2340	Malvern
    GPC
	HB#
    2227	Precision
    Waterbath
	HB#
    2275	Beckman
    HPLC
	HB#
    2242	Beckman
    HPLC
	HB#
    2318	Beckman
    Microfuge 12
	Computer
    # 48	DELL
    Computer for JASCO CD
	Computer
    # 49	IBM
    Computer for Beckman HPLCs
	Computer
    # 50	DELL
    Computer for GPC

 

    	B1-3

    	 

    

 

	RM#221	Equipment
    Description
	HB#
    3299	Labconco
    Freezer dry System
	HB#
    3417	UVP
    UVGL-58 Paper Chromatography
	HB#
    3448	Fotodyne
    Gel Imaging System
	HB#2277	Beckman
    Ultracentrifuge
	HB#
    2246	Beckman
    Ultracentrifuge
	HB#
    2188	Mettler
    Toledo Balance
	HB#
    2187	Mettler
    Toledo Balance
	HB#
    1588	Labconco
    Hood
	HB#
    3152	Mettler
    Toledo Karl Fisher
	HB#
    2349	UVP
    Gel Imaging System
	Computer
    #33	ACER
    Computer for UVP
	Computer
    #44	IBM
    Computer for Beckman
	Computer
    #44	IBM
    Computer for Beckman
	 	 
	RM#
    222	Equipment
    Description
	HB#
    1799	Fisher
    Scientific Incubator
	HB#
    3046	Thermo
    Scientific Nanodrop
	HB#
    2219	Sartorius
    Balance
	HB#
    3274	Sorvall
    Centrifuge
	HB#
    3002	Horiba
    Spectrofluorometer
	HB#
    1894	GE
    Refrigerator/Freezer
	HB#
    3430	Centromix
    Microcentrifuge
	HB#
    3438	Pharmacia
    Electrophoresis Power Supply
	HB#
    3185	Invitrogen
    Electrophoresis Power Supply
	HB#
    1507	Thermolyne
    Heating Block
	HB#
    1800	Thermolyne
    Heating Block
	HB#
    3067	Fisher
    Scientific Heating Block
	HB#
    1908	Bio
    Rad Electrophoresis Power Supply
	HB#
    3432	Bio
    Rad Electrophoresis Power Supply
	HB#
    2289	Benchmark
    Shaker
	HB#
    3433	Labline
    Plate Rotator
	Computer
    #46	Dell
    computer for Horiba Spectrofluorometer
	 	 

	RM
    #130	Equipment
    Description
	HB#
    2174	Ludlum
    Geiger Counter
	HB#
    3350	Ludlum
    Geiger Counter
	HB#
    1593	Fume
    Hood
	 	 
	RM#131	Equipment
    Description
	HB#
    2005	Sorvall
    Centrifuge
	N/A	Controlled
    Environment Incubator Shaker
	HB#
    3300	GE
    Freezer
	HB#
    1891	Admiral
    Double door Refrigerator
	 	 
	Polymer
    Manufacturing	Equipment
    Description
	HB#
    3317	Thermo
    Scientific Liquid Nitrogen Tank

 

    	B1-4

    	 

    

 

Administrative
Offices (Inventory List)

 

	 	● 	Front
    Office Conf. Rm- Chairs-7, Desk-1, Phone-1, Chalkboard-1 Table-1
	 	●	Front
    Rec Area - Chairs-3, Desk-1, Phone-1 , File Cabinets-2, Scanner-1/(Fujitsu), Monitor-1, Laptop-1/(#LT-02), Shredder-1/(Fellowes),
    Glass Table-1
	 	● 	Open
    Area Chairs-3, Desk-1 (with 2 corner extensions), Printer-1/(Sharp MX-624ON), Shredmaster-1/(6550X), File Cabinets-5, Bulletin
    Boards-2, Monitors-3, Computers-3 (#76, # 12, no #)
	 	● 	Open
    Area/Back) File Cabinet-1, Mail slots/For employees/(Large) 
	 	●	Rm
    107 Chairs-2, Desks-2, Monitors-3, Computer-1 (#15), Laptops-2 (#lt-07), (Laptop #36), File Cabinets-2
	 	●	Rm-104
    Chairs-2, Desks-2, Monitors-2, Computer-1(#16), Laptop-1(#93), Phones-2, File Cabinets-2, DVD Player/(Samsung), Laminating
    Machine-1 (Royal Sovereign)
	 	●	Rm-108
    File Cabinets-7
	 	●	Rm-114
    File Cabinets-28
	 	●	Rm-115
    File Cabinets-15
	 	●	Rm-117
    Chairs-2, Desks-3, Monitor-1, Laptop-1/(#79), Phone-1, File Cabinets-2
	 	●	Rm-118
    Chairs-2, Desks-2, Computer-1(#35), File Cabinet-1, Phone-1, Bulletin Board-1
	 	● 	Rm-119
    Chairs-2, Desk-1(with 2 corner extensions), File Cabinets-2, Monitor-1, Laptops-3/Computer #73, (no #’s for the other
    2, Phone-1
	 	● 	Rm-120
    Chairs-2, Desk-1 (with 2 corner extensions), Monitor-1, Laptop-1/(computer# 69), File Cabinet-1 Phone-1
	 	● 	Rm-121
    Chairs-2, Desk-1 (with 2 corner extensions), Phone-1, File Cabinets-2, Monitor-1, Computer-1 (#14) Printer-1 (MFC-8480DN)
	 	● 	Rm-122
    Chairs-2, Desk-1(with -2 corner extensions), Phone-1, Printer-1, Monitor-1 Laptop(no #)
	 	● 	Rm-205
    Chairs-2, Desk-1(with 2 corner extensions) Phone-1, File Cabinets-3, Monitor-1, Printer-1
	 	● 	Rm-206
    Chairs-2, Desk-1 (with 2 corner extensions) Phone-1 File Cabinets-2, Monitor-1, Laptop-1, Printer-1, Bulletin Boards-2 , Small
    cart-1
	 	● 	Rm-207
    Chairs-2, Desk-1 (with 2 corner extensions) Phone-1 File Cabinets-3, Monitor-1, Laptop-1,(Computer #78)
	 	● 	Rm-208
    Chairs-5, Desk-1, Table-1, Phone-1, File Cabinets-1, Monitor-1, Laptop-1,(no #), Printer-1
	 	● 	Rm-209
    Chairs-3, Desk-1, File Cabinets-3, Cart-1, Phone-1, Monitor-1, Laptop-1(Computer #29), Bulletin Board-1
	 	● 	Rm-214
    Chairs-7, Desks-2, Table-1, Phone-1
	 	● 	Upstairs
    Conf Area/Open.......Chairs-8, Table-1, File Cabinets-8, Phone-2/(wall mounted), Lockers-18
	 	● 	Upstairs
    Conf Rm-502 Chairs-17, Table-3/(1 Large/2 Small), Sofa-1, File Cabinets-3, Polycom-1, Printer-1/(Brother MFC-9460CDN), Flatscreen
    TV,(Panasonic)-1, Presentation Board-1, Large Chalkboard-1, Bullentin Board-1, Extra Cabinets-2/wood
	 	● 	Rm-503-
    Chairs-6, Table-1, Sharp TV-1, Large Cart-1, Presentation Board/Chalkboard-1, Bulletin Board-1
	 	● 	Boiler
    Area Chair-1, Desk-1, File Cabinet-1, Phone-1, Monitor-1, Laptop-1(no #),
	 	● 	Rm-604
    Chairs-3, Desks-3, Monitors-4, Phone-1, File Cabinets-2, Laptops-2/(no #’s), Computer-1(#13), Bulletin Board-1
	 	● 	Rm-605
    Chairs-3, Desks-2, Phone-2, FileCabinet-1,Computer-1(no #), Laptop-1(no #)
	 	● 	Rm-606
    Printer-2/(Hp Officejet 7310,), (Ricoh SPC410DN)/ Monitors-4, Phone-1, Laptops-2/(#40/no # for other laptop), Computer-8 (#42,
    #11, #61,#22, #37, #25, #31,/no # )
	 	● 	Rm-607
    Desk-1, Phone-1, Bulletin Boards-3, Printer-1/(Hewlett Packard Design Jet 750C Plus Plotter
	 	● 	Rm
    608 Desk-1, Phone-1, Chairs-3, Bulletin Boards-2, mail slots-2/small
	 	● 	 Rm-609
    Desks-2, Chairs-2, File Cabinets-3, Laptops-3(computer # 21/no # for the other 2), Computer-10 (#33, #60, #26, #30, #22, #10,
    #9, #28, #8, #27), Servers-6
	 	● 	Rm-610
    Chairs-3, Desks-2, Phone-1, File Cabinets-4,Monitors-2, Bulletin boards-2, Laptop-1(no #)
	 	● 	Rm-611
    Chairs-10, Desk-1, Bulletin boards-2, Phone-1 File cabinets-2, Laptops-3/(computer# 26/no #’s for the other 2)
	 	● 	Rm
    -612 Chairs-4, Desk-1, Phone-1, File Cabinets-4, Bulletin board-1
	 	● 	Rm-613
    Chairs-2, Desk-1, File cabinets-6, Phones-2, Printer-1(Hp), Laminating Machine/(Epson 4490 Photo Perfection, Monitors-11,
    Computer-12 (#17, #7, #77, #75,#2, #19, #3., #4/the other 4 no #’s)

 

    	B1-5

    	 

    

 

 

 

    	B1-6

    	 

    

 

 

    	B1-7

    	 

    

 

EXHIBIT
B-3

 

FORM
OF SELLER LEASE

 

[Attached]

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