Exhibit 10.1


 


AMENDED AND RESTATED EARLY ACCESS AGREEMENT


 


This exclusive Early Access Agreement
(“Agreement”) is made and entered into the 20th day of May, 2016, (“Effective Date”)
by and between


 


Hemispherx
Biopharma, Inc, a company formed and registered under the laws of Delaware and located at One Penn Center, 1617 JFK Boulevard,
Suite 500, Philadelphia, PA 19103, U.S.A. (hereinafter
referred to as “HEMISPHERX”),


 


and


 


Impatients N.V., a company formed
and registered under the laws of the Netherlands, and located at Pilotenstraat 45, 1059 CH, Amsterdam, The Netherlands (hereinafter
referred to as “IMPATIENTS”),  


 


hereinafter each of HEMISPHERX and IMPATIENTS,
referred individually as a “Party” and collectively as the “Parties”.


 


RECITALS


 


WHEREAS,
HEMISPHERX has developed, and is developing the Product (as defined below), and owns or controls certain patent rights, and technical
and scientific information relating to, and the global exclusive rights to distribute, market and sell Product,


 


WHEREAS,
IMPATIENTS specialises under the brand myTomorrows in services related to the supply
and distribution of products to patients in Early Access Programs (also referred to as EAP and as defined below) through a patient
and physician platform (hereinafter referred to as the “myTomorrows platform”),


 


WHEREAS,
HEMISPHERX is willing to grant IMPATIENTS the exclusive right to develop and execute Early Access Programs in the Territory (as
defined below) and to supply quantities of Product to IMPATIENTS for these Early Access Programs in the Territory,


 


WHEREAS,
IMPATIENTS agrees to accept such right and to use the Product for Early Access Programs from
HEMISPHERX pursuant to the terms of this Agreement, and


 


WHEREAS,
the Parties wish to set forth the terms and conditions under which HEMISPHERX grants the exclusive right and supplies the Product
and IMPATIENTS implements the Early Access Program.


 


NOW THEREFORE, in consideration of the
foregoing premises and the mutual covenants set forth below, the Parties hereto, intending to be legally bound, agree as follows:


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




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1. Definitions


 


The following
terms when used in this Agreement, shall have the meanings set forth in this clause:


 


		1.1	“Accounting Standards”
                                         with respect to a Party means that such Party shall maintain records and books of accounts
                                         in accordance with International Financial Reporting Standards as issued by the International
                                         Accounting Standards Board.



 


		1.2	“Affiliate” means,
                                         as to any person or entity, any other person or entity, which controls, is controlled
                                         by, or is under common control with such person or entity. A person or entity shall be
                                         regarded as in control of another entity only if it owns or controls, directly or indirectly,
                                         at least fifty percent (50%) of the equity securities or other ownership interests in
                                         the subject entity entitled to vote in the election of directors or with the power to
                                         direct or elect management of such subject entity.



 


		1.3	“HEMISPHERX Patents”
                                         means all of the Patents that are (a) under Control by HEMISPHERX or any of its Affiliates
                                         as of the Effective Date or at any time during the Term, and (b) reasonably necessary
                                         or useful (or, with respect to Patent applications, would be reasonably necessary or
                                         useful if such Patent applications were to issue as Patents) for the development, manufacture,
                                         or use or sale of the Product.



 


		1.4	“Applicable Law”
                                         means federal, state, local, national and supra-national laws, statutes, rules, and regulations,
                                         including any rules, regulations, guidelines, or other requirements of the Regulatory
                                         Authorities, major national securities exchanges or major securities listing organizations,
                                         that may be in effect from time to time during the Term and applicable to a particular
                                         activity and/or country or other jurisdiction hereunder.



 


		1.5	“Confidential Information”
                                         means any Information provided orally, visually, in writing or other form by or on behalf
                                         of one Party to the other Party in connection with this Agreement, whether prior to,
                                         on, or after the Effective Date, including information relating to the terms of this
                                         Agreement, the Product (including the Regulatory Documentation and Regulatory Data),
                                         any use of the Product, any know-how with respect thereto developed by or on behalf of
                                         the disclosing Party or its Affiliates, or the scientific, regulatory or business affairs
                                         or other activities of either Party. Notwithstanding the foregoing, (a) jointly
                                         owned Know-How shall be deemed to be the Confidential Information of both Parties, and
                                         both Parties shall be deemed to be the receiving Party and the disclosing Party with
                                         respect thereto; and (b) after IMPATIENTS proceeds with the EAP, all Regulatory
                                         Documentation developed by IMPATIENTS shall be deemed to be the Confidential Information
                                         of HEMISPHERX, and HEMISPHERX shall be deemed to be the disclosing Party and IMPATIENTS
                                         shall be deemed to be the receiving Party with respect thereto.



 


		1.6	“Control” means,
                                         with respect to any item of Information, Regulatory Documentation, material, Patent,
                                         or other property right existing on or after the Effective Date and during the Term,
                                         the possession of the right, whether directly or indirectly, and whether by ownership,
                                         license, covenant not to sue, or otherwise (other than by operation of the license and
                                         other grants herein), to grant a license, sublicense or other right (including the right
                                         to reference Regulatory Documentation) to or under such Information, Regulatory Documentation,
                                         material, Patent, or other property right as provided for herein without violating the
                                         terms of any agreement or other arrangement with any third party; provided, however,
                                         neither Party shall be deemed to Control any item of Information, Regulatory Documentation,
                                         material, Patent, or other property right of a third party if access requires or triggers
                                         a payment obligation.



 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




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		1.7	“Early Access Program”
                                         or “EAP” means the activities directed to (a) the education of physicians
                                         and patients regarding the possibility of early access to innovative medical treatments
                                         not yet the subject of a Marketing Authorization through named-patient use, compassionate
                                         use, expanded access and hospital exemption (b) patient and physician outreach related
                                         to the platform, (c) the securing of Early Access Approvals, for the use of such treatments,
                                         (d) the distribution and sale of such treatments pursuant to such Early Access Approvals,
                                         (e) pharmacovigilance activities in accordance with the Pharmacovigilance agreement,
                                         attached as Exhibit 6 and/or (f) to the extent permitted by Applicable Law, the collection
                                         of data, including but not limited to patient-reported outcomes, doctor-reported experiences
                                         and registry data as set out in more detail in Exhibit 9.



 


		1.8	“EAP Plan” means
                                         the plan to be agreed by the JSC for the initiation and performance of an Early Access
                                         Program for Product in the Field. The EAP Plan will be attached hereto as Exhibit 1.



 


		1.9	“Early Access Approvals”
                                         means the permissions, exemptions, approvals, authorizations and/or waivers required
                                         by Regulatory Authorities for medical treatments, not subject of a Marketing Authorization
                                         in the relevant country, to be sold to a pharmacy or wholesaler, to be dispensed to a
                                         physician, to be administered to and/or used by a patient.



 


		1.10	“Field” means treatment
                                         of chronic fatigue syndrome.



 


		1.11	“First Commercial Sale”
                                         means, with respect to a Product and a country, the first sale for monetary value for
                                         ultimate use by the patient of such Product in such country after Marketing Authorization
                                         for such Product has been obtained in such country. Sales prior to receipt of Marketing
                                         Authorization for such Product, such as so-called “treatment IND sales,”
                                         “named patient sales,” or other “compassionate use sales,” shall
                                         not be construed as a First Commercial Sale.



 


		1.12	“Good Manufacturing Practice”
                                         or “GMP” means the current good manufacturing practices applicable
                                         from time to time to the manufacturing of a Product or any intermediate thereof pursuant
                                         to Applicable Law.



 


		1.13	“Information” means
                                         knowledge of a technical, scientific, business, and other nature, including know-how,
                                         technology, means, methods, processes, practices, formulae, instructions, skills, techniques,
                                         procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures,
                                         computer programs, apparatuses, specifications, data, results and other material, Regulatory
                                         Data, and other biological, chemical, pharmacological, toxicological, pharmaceutical,
                                         physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control
                                         data and information, including study designs and protocols; assays, and biological methodology;
                                         in each case (whether or not confidential, proprietary, patented or patentable, of commercial
                                         advantage or not) in written, electronic or any other form now known or hereafter developed.



 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




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		1.14	“Joint Steering Committee
                                         or JSC” means the joint steering committee to be established by the Parties
                                         as referred to in Clause 2.



 


		1.15	“Know How” means
                                         information and materials, whether or not confidential, including, but not limited to,
                                         pharmaceutical, chemical, products, economic and commercial information, including and
                                         not limited to all market information, strategies and tactics relevant to the Product
                                         in the Territory and any lists of physicians and/or clinicians active in the Field in
                                         the Territory, technical and non-technical manufacturing process and equipment data and
                                         information, product and process validation data, the results of tests on products, reports
                                         and results of product assays, pre-clinical and clinical studies, and drawings, plans,
                                         diagrams, specifications and/or other documents containing said information relating
                                         to the Product.



 


		1.16	“Manufacturer“
                                         means the legal entity that physically manufactures and/or fills and/or finishes and/or
                                         labels and/or stockpiles cGMP grade Product.



 


		1.17	“Marketing Authorization”
                                         means, with respect to a country, region or other jurisdiction in the Territory and in
                                         the Field, any and all approvals (including Drug Approval Applications), licenses, registrations,
                                         or authorizations of any Regulatory Authority necessary to commercially distribute, sell,
                                         or market Product in the Field in such country or other jurisdiction, including, where
                                         applicable, (a) pre- and post-approval regulatory approvals (including any prerequisite
                                         manufacturing approval or authorization related thereto), and (b) approval of Product
                                         labeling in the Field.



 


		1.18	“Material Event”
                                         means, in the context of the EAP, any event which would, in HEMISPHERX’s reasonable
                                         opinion, (a) adversely affect HEMISPHERX’s ability to market and distribute the
                                         Product outside of the EAP, including but not limited to its ability to obtain Marketing
                                         Authorisation in any country or region, (b) adversely effect HEMISPHERX’s ability
                                         to use its intellectual property relating to its brand or the Product, or (c) bring HEMISPHERX’s
                                         business into disrepute. For the avoidance of doubt, a Material Event shall not include
                                         any event relating to the performance of pharmacovigilance activities in relation to
                                         which the Parties have entered into the Pharmacovigilance Agreement.



 


		1.19	“Net EAP Sales”
                                         means the gross amount invoiced by IMPATIENTS or its affiliates to non-affiliated third
                                         parties for the sale of Product, less the following reasonable and customary deductions
                                         consistent with IMPATIENTS’ cash or accrual accounting method to the extent applicable
                                         to such invoiced amounts (to the extent each is actually incurred and included in the
                                         invoiced gross sales price) in accordance with Accounting Standards:



 


		(a)	all mutually agreed trade discounts
                                         or rebates;



 


		(b)	amounts for claims, allowances or
                                         credits for rejections or returns;



 


		(c)	packaging, handling fees and costs
                                         of freight, insurance, sales taxes, duties and other governmental charges (including
                                         value added tax), but excluding what is commonly known as income taxes.



 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 







    	 	 	4



     


    

 


The specific
deductions, as set out in Exhibit 8, taken under, and the general provision of, (a) through (c) above may be adjusted periodically
after agreement between both Parties as necessary to reflect amounts actually incurred.


 


		1.20	“Net Sales” means
                                         the gross amount invoiced by HEMISPHERX or its affiliates to non-affiliated third parties
                                         for the sale of Product, less the following reasonable and customary deductions consistent
                                         with HEMISPHERX’s cash or accrual accounting method to the extent applicable to
                                         such invoiced amounts (to the extent each is actually incurred and included in the invoiced
                                         gross sales price) in accordance with Accounting Standards:



 


		(a)	all mutually agreed trade discounts,
                                         or rebates;



 


		(b)	amounts for claims, allowances or
                                         credits for rejections or returns;;



 


		(c)	packaging, handling fees and costs
                                         of freight, insurance, sales taxes, duties and other governmental charges (including
                                         value added tax), but excluding what is commonly known as income taxes.



 


The specific
deductions taken under, and the general provision of, (a) through (c) above may be adjusted periodically after agreement between
both Parties as necessary to reflect amounts actually incurred.


 


For the avoidance
of doubt, Net Sales shall not include sales for resale to Affiliates of HEMISPHERX.


 


For purpose
of this definition 1.20, a sale shall also include a transfer or other disposition for consideration other than cash, in which
case such consideration shall be valued at the fair market value thereof. Transfers or dispositions for charitable purposes or
for pre-clinical, clinical, regulatory or governmental purposes prior to receiving Marketing Authorization are not considered
a "sale".


 


		1.21	“Patents”
                                         means (a) all national, regional and international patent applications, including provisional
                                         patent applications, and all applications claiming priority therefrom, including divisionals,
                                         continuations, continuations-in-part, provisionals, converted provisionals and continued
                                         prosecution applications; (b) any and all national patents issued or granted from
                                         the foregoing patent applications, including utility patents, utility models, petty patents
                                         and design patents and certificates of invention; (c) any and all extensions or
                                         restorations by existing or future extension or restoration mechanisms, including revalidations,
                                         reissues, re-examinations and extensions (including any supplementary protection certificates
                                         and the like) of the foregoing patents or patent applications ((a) and (b)); and (d)
                                         any similar rights, including so-called pipeline protection or any importation, revalidation,
                                         confirmation or introduction patent or registration patent or patent of additions to
                                         any of such foregoing patent applications and patents. 



 


		1.22	“Patient on Treatment”
                                         means patients that have met all the criteria to receive the Product under an EAP as
                                         set out in the EAP Plan and who have had the Product prescribed for them.



 


		1.23	Pharmacovigilance Agreement”
                                         or “PhVA” means the pharmacovigilance agreement attached as Exhibit 6.



 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




    	 	 	5



     


    

 


		1.24	“Price” means
                                         the price of Product invoiced by IMPATIENTS to third parties other than Affiliates of
                                         IMPATIENTS in accordance with Exhibit 4 excluding any VAT or other taxes or levies that
                                         are applicable.



 


		1.25	“Product”
                                         means all available stock-keeping units (SKU)’s of the product referred to as of
                                         the Effective Date, as Ampligen®, a double-stranded RNA product, supplied
                                         ready packed and labeled, such labeling to include the Ampligen Trademark and the fact
                                         that the Product is manufactured and supplied by HEMISPHERX on both primary and secondary
                                         containers, quality tested and QP released in accordance with applicable pharmaceutical
                                         law and regulations.



 


		1.26	“Quality Agreement
                                         or QA ” means the quality agreement attached as Exhibit 5 to this Agreement.



 


		1.27	“Regulatory Authority”
                                         means any applicable supra-national, federal, national, regional, state, provincial,
                                         or local governmental or regulatory authority, agency, department, bureau, commission,
                                         council, or other entities (e.g., the FDA, EMA and PMDA) regulating or otherwise exercising
                                         authority with respect to activities contemplated in this Agreement.



 


		1.28	“Regulatory Data”
                                         shall have the meaning given to it in Clause 4.2 of this Agreement.



 


		1.29	“Regulatory Documentation”
                                         means all (a) applications (including all INDs and Drug Approval Applications and
                                         other regulatory filings), registrations, licenses, authorizations, and approvals (including
                                         Regulatory Approvals); (b) correspondence and reports submitted to or received from
                                         Regulatory Authorities (including minutes and official contact reports relating to any
                                         communications with any Regulatory Authority) and all supporting documents with respect
                                         thereto, including all regulatory drug lists, advertising and promotion documents, adverse
                                         event files, and complaint files; and (c) pre-clinical and clinical data, and data
                                         contained or relied upon in any of the foregoing, in each case (a), (b), and (c) relating
                                         to Product.



 


		1.30	“Specifications”
                                         means all data necessary to manufacture the Product and contained in the most recent
                                         version of the product specification file, IMPD or IND.



 


		1.31	“Territory”
                                         means all the countries of the European Union and Turkey.



 


		1.32	“Trademark”
                                         means any word, name, symbol, color, designation or device or any combination thereof
                                         that functions as a source identifier, including any trademark, trade dress, brand mark,
                                         service mark, trade name, brand name, logo, business symbol or domain names whether or
                                         not registered.



 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 






    	 	 	6



     


    

  


			2     –
EAP activities & management




  


		2.1	EAP Activities.



 


IMPATIENTS shall perform EAP
activities, including selling and distributing the Product in the Territory. IMPATIENTS shall use reasonable commercial efforts
to assure that all requested and relevant information is presented to regulatory authorities, decision makers, patients and/or
responsible medical specialists, including informing patients and health care practitioners in general about their opportunities
to apply for Early Access Approvals in the Territory.


 


		2.2	Collaborative Committees.



 


As soon as practical after the
Effective Date, but no later than thirty (30) days thereafter, the Parties shall establish a joint steering committee (the “Joint
Steering Committee” or “JSC”), which shall (a) oversee the EAP plan for the Product in the Territory, (b) resolve
Disputes that may arise in any subcommittees formed by the JSC, (c) coordinate the Parties’ activities under this Agreement,
including oversight of any subcommittees formed by the JSC, and (d) perform such other functions as are set forth herein
or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement. The details of
the composition, operating procedures and responsibilities of the Collaborative Committees are described in Exhibit 2.


 


		2.3	Packaging.



 


Subject to the provision by HEMISPHERX
of appropriately labeled and packaged Product and associated materials, IMPATIENTS shall ensure that such amounts of the Product
and its associated materials as are supplied and distributed under the EAP Program shall prominently display the Product Trademark,
together with the information that the Product is manufactured and supplied by HEMISPHERX.


 


			3    –
                                         Grants of rights, disclosure of know how



 


		3.1	Appointment.



 


		3.1.1	HEMISPHERX
                                         hereby appoints IMPATIENTS as its exclusive service provider to perform EAP activities
                                         for Product in the Field in the Territory. 



 


		3.1.2	HEMISPHERX hereby grants IMPATIENTS
                                         an exclusive, non-transferable, royalty-free right to reproduce and use the Product’s
                                         Trademarks solely in connection with performing the EAP activities for Product in the
                                         Field in the Territory, subject to the terms and conditions set forth herein, including
                                         in Exhibit 3.



 


		3.2	IMPATIENTS
                                         Know How Contribution. 



 


IMPATIENTS
undertakes to contribute its Know How to perform the EAP, including but not limited its EAP technical and business knowledge regarding
patient and physician outreach, regulatory and legal support, pharmacovigilance, reimbursement, data collection, logistics and
marketing.


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


  




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		3.3	HEMISPHERX
                                         Know How Disclosure. 



 


Immediately
after the Effective Date, HEMISPHERX shall collaborate with IMPATIENTS make available to IMPATIENTS, in whatever form IMPATIENTS
may reasonably request, Regulatory Documentation, HEMISPHERX Know How, and any other Information relating directly or indirectly
to the Product and reasonably required to implement and manage the EAP in the Territory (including, but not limited to, information
related to Manufacturing), to the extent not done so already, and thereafter immediately upon the availability of such Regulatory
Documentation, HEMISPHERX Know How, or other Information. For the avoidance of doubt, where necessary, HEMISPHERX will and shall
cause its Affiliates and collaborators, without additional compensation, to make available to IMPATIENTS relevant information
agreed upon with IMPATIENTS under this Clause 3.3.


 


		3.4	HEMISPHERX
                                         Know How Assistance. 



 


HEMISPHERX,
at its sole cost and expense, shall provide IMPATIENTS with reasonable assistance required in order to transfer to IMPATIENTS
the Regulatory Documentation, HEMISPHERX Know How and other Information required to be produced hereunder, in each case in a timely
manner. HEMISPHERX shall reasonably assist IMPATIENTS with respect to the implementation of the EAP for the Product. 


 


			4    - Regulatory matters



 


		4.1	Regulatory
                                         Activities.



 


		4.1.1	IMPATIENTS
                                         shall have the sole and exclusive right to make contact with patients and physicians
                                         relating to the EAP of Product, and to file applications for Early Access Approvals therefor
                                         (including the setting of the overall regulatory strategy therefor), and to communicate
                                         with the Regulatory Authorities to secure Early Access Approvals for Product in the Territory.
                                         HEMISPHERX shall support IMPATIENTS as may be reasonably necessary in obtaining Early
                                         Access Approvals for the Product, and in the activities in support thereof, including
                                         providing necessary documents or other materials required by Applicable Law to obtain
                                         Early Access Approvals, in each case in accordance with the terms and conditions of this
                                         Agreement.



 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 


 




    	 	 	8



     


    

  


		4.1.2	HEMISPHERX
                                         shall collaborate with IMPATIENTS to provide IMPATIENTS with (a) access to or copies
                                         of all material written or electronic correspondence (other than regulatory filings)
                                         relating to the development of Product in the Field received by HEMISPHERX or its Affiliates,
                                         collaborators or licensees from, or filed by HEMISPHERX or its Affiliates, collaborators
                                         or licensees with, the Regulatory Authorities, and (b) copies of all meeting minutes
                                         and summaries of all meetings, conferences, and discussions held by HEMISPHERX or its
                                         Affiliates, collaborators or licensees with the Regulatory Authorities relating to the
                                         development or commercialization of Product in the Field, including copies of all contact
                                         reports produced by HEMISPHERX or its Affiliates or licensees, in each case ((a) and
                                         (b)) within fifteen (15) Business Days of its receipt, forwarding or production of the
                                         foregoing, as applicable. If such written or electronic correspondence received from
                                         any such Regulatory Authority relates to the withdrawal, suspension, or revocation of
                                         a Regulatory Approval or Early Access Approval for Product in the Field, the prohibition
                                         or suspension of the supply of a Product in the Field, or the initiation of any investigation,
                                         review, or inquiry by such Regulatory Authority concerning the safety and quality of
                                         a Product in the Field, the notified Party shall notify the other Party and provide the
                                         other Party with copies of such written or electronic correspondence as soon as practicable.



 


		4.1.3	HEMISPHERX
                                         shall, in accordance with the Quality Agreement, make every reasonable effort to notify
                                         IMPATIENTS promptly following its determination that any event, incident, or circumstance
                                         has occurred that may result in the need for a recall, market suspension, or market withdrawal
                                         of a Product in the Territory in the Field, and shall include in such notice the reasoning
                                         behind such determination, and any supporting facts. HEMISPHERX (or its licensee) shall
                                         have the right to make the final determination whether to voluntarily implement any such
                                         recall, market suspension, or market withdrawal in the Territory. If a Regulatory Authority
                                         in the Territory mandates a recall, market suspension, or market withdrawal, then HEMISPHERX
                                         (or its licensee) shall initiate such a recall, market suspension, or market withdrawal
                                         in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals
                                         undertaken pursuant to this Section 4.1.3, HEMISPHERX or its licensee, whichever responsible
                                         for the recall, market suspension, or market withdrawal, shall be solely responsible
                                         for the execution thereof, and IMPATIENTS shall reasonably cooperate in all such recall
                                         efforts.



 


		4.2	Regulatory
                                         Data.



 


Within the Field, each
Party shall promptly provide to the other Party copies of, or access to all non-clinical and clinical data, and other information,
results, and analyses with respect to any development activities that are carried out by on or behalf of or otherwise controlled
by such Party or any of its Affiliates, collaborators or licensees (collectively, “Regulatory Data”), when such Regulatory
Data becomes available. For the avoidance of doubt, the requirements under this Clause 4.2 shall include that HEMISPHERX shall
provide IMPATIENTS with copies of up-to-date versions of (a) the EU GMP certificate of the manufacturing site, (b) if applicable,
the Product’s GMP certificate, (c) the Manufacturer’s manufacturing license for the Product, (d) Product stability
data and certificate of analysis, together with all other Know How that IMPATIENTS is required to include, or may need to include,
in its Early Access Approval applications.


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




    	 	 	9



     


    

 


		4.3	Pharmacovigilance.



 


Parties shall enter into a separate
agreement related to the responsibility and performance of pharmacovigilance activities related to the Product. This Pharmacovigilance
Agreement is attached as Exhibit 6.


 


		4.4	Compliance.



 


Each Party shall perform or
cause to be performed, any and all of its development activities, in good scientific manner and in compliance with all Applicable
Law.


 


		4.5	Records.



 


		4.5.1	Each
                                         of HEMISPHERX and IMPATIENTS shall, and shall ensure that its third party providers shall,
                                         maintain records in sufficient detail and in good scientific manner appropriate for regulatory
                                         purposes, and in compliance with Applicable Law, which shall be complete and accurate
                                         and shall properly reflect all work done and results achieved in the performance of its
                                         activities. HEMISPHERX or IMPATIENTS shall and retain all such records, as the case may
                                         be, for at least three (3) years after termination of this Agreement, or for such longer
                                         period as may be required by Applicable Law.



 


		4.5.2	Each
                                         Party shall have the right, during normal business hours and upon reasonable notice,
                                         to inspect and make copies of all records of the other Party that pertain to the subject
                                         matter of this Agreement and that are reasonably required by such Party, except, without
                                         limitation, for files that cannot be shared due to applicable privacy regulations or
                                         that are subject to the attorney-client privilege. The inspecting Party shall maintain
                                         such records and the information disclosed therein in accordance with the confidentiality
                                         clauses of Clause 9 of this Agreement.



 


		4.5.3	Without
                                         prejudice to the provisions of Clause 2, the JSC shall determine what reports shall be
                                         generated to track the EAP activities, including the content and timing thereof. 



 


			5   – Exclusive distribution,
                                         supply and manufacture 



 


		5.1	Distribution.



 


HEMISPHERX hereby appoints IMPATIENTS
as its sole and exclusive distributor in respect of EAP use of Product for use in the Field in the Territory, limited to EAP use
of Product in accordance with Early Access Approvals.


 


		5.2	Product Supply.



 


		5.2.1	HEMISPHERX undertakes and agrees
                                         to supply to IMPATIENTS on an exclusive basis, IMPATIENTS’
                                         requirements of Product ordered in accordance with the terms of this Agreement, for distribution
                                         and sale in the Territory, limited to EAP use of Product in accordance with Early Access
                                         Approvals.



 


		5.2.2	IMPATIENTS
                                         undertakes and agrees to obtain its requirements of Product for use in the Field
                                         from HEMISPHERX in accordance with the terms of this Agreement.



 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




    	 	 	10



     


    

 


		5.3	Product Manufacturing.



 


		5.3.1	Manufacturing.



 


HEMISPHERX shall solely be
responsible for the manufacturing, fill & finish, labeling and, if applicable, stockpiling of cGMP grade Product in compliance
with the Quality Agreement attached as Exhibit 5, and shall exert its reasonable commercial best efforts to provide quantities
of cGMP Product sufficient to meet the requirements of the EAP. If HEMISPHERX contracts the manufacturing and/or filling and/or
finishing and/or labeling and/or stockpiling of Product to a third party, such third party shall be considered a Manufacturer.
HEMISPHERX will ensure that all relevant obligations deriving from this Agreement (including the Quality Agreement) between Parties
are part of the contractual relationship between HEMISPHERX and any Manufacturer. HEMISPHERX shall provide all required documentation
to IMPATIENTS related to the manufacturing for purposes of furthering the activities of the EAP.


 


		5.3.2	Interruption of Supply.



 


If HEMISPHERX is unable to
meet IMPATIENTS’ requirements for Product, HEMISPHERX will notify IMPATIENTS and the JSC will meet as soon as possible to
negotiate a possible resolution.


 


			6   - Supply of Product and Invoicing



 


		6.1	Notification of Requirements.



 


IMPATIENTS shall notify HEMISPHERX
of its estimated Product requirements for the following {***} months {***}  days before the start of {***}
(“Rolling Forecast”). Said estimate shall not constitute a firm commitment by IMPATIENTS. HEMISPHERX shall, within
10 business days of receipt of such Rolling Forecast, indicate to IMPATIENTS if it agrees to such Rolling Forecast. The enrollment
of patients into the EAP and the Rolling Forecast shall be mutually agreed between the Parties.


 


		6.2	Available Stock.



 


HEMISPHERX shall use its best
efforts to ensure that sufficient quantities of Product for 6 months of treatment for all patients then enrolled in the EAP are
in stock at the warehouse of IMPATIENTS’s logistics service provider (“LSP”). In addition, HEMISPHERX shall
use reasonable commercial efforts to ensure that sufficient quantities of Product for the following six months projected sales,
based on the most recent Rolling Forecast, as agreed in accordance with Clause 6.1, are in stock at the warehouse of IMPATIENTS’
LSP. The legal ownership of the stock in the warehouse of IMPATIENTS’ LSP (further referred to as “Consignment Stock”)
shall remain with HEMISPHERX and will at no time be transferred to IMPATIENTS or the LSP. At the time of IMPATIENTS’ delivery
of the Product through its LSP to its clients, legal ownership of the Product will directly transfer from HEMISPHERX to the relevant
client of IMPATIENTS. Any costs related to the keeping Consignment Stock shall be at the expense of IMPATIENTS.


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




    	 	 	11



     


    

 


		6.3	Product Shipment.



 


HEMISPHERX shall deliver the
Product DDP (INCOTERMS 2010) at the Consignment Stock warehouse address of IMPATIENTS’ LSP. At the warehouse of IMPATIENTS’
LSP, Product will be made ready for delivery to IMPATIENTS’ clients, in a manner controlled by IMPATIENTS and in accordance
with the Quality Agreement.


 


		6.4	Shipment Authorization.



 


HEMISPHERX hereby authorizes
IMPATIENTS to order its LSP to use Product from the Consignment Stock for the fulfilling of orders from IMPATIENTS’ clients
without further approval from HEMISPHERX. HEMISPHERX shall make sure the Consignment Stock is replenished in a timely manner to
comply with the stock level requirement as mentioned in Clause 6.2.


 


		6.5	Invoice.



 


IMPATIENTS shall notify HEMISPHERX
at the beginning of {***} of all fulfilled Product orders and Net EAP Sales (in Euros (€)) of Product from the preceding
{***}. HEMISPHERX shall send IMPATIENTS an invoice in Euros (€) for 65% of Net EAP Sales in such {***} and
IMPATIENTS shall pay the amount of such invoice to HEMISPHERX in Euros (€) within {***} days of receipt.


 


		6.6	Product Pricing.



 


The Price of the Product is specified
in Exhibit 4. Prices are stated excluding VAT or other taxes or levies.


 


			7   – Compensation to IMPATIENTS
                                         for agreed services



 


		7.1	Royalty Obligation.



 


		7.1.1.1	During the EAP, IMPATIENTS
                                         shall, to the extent permitted by Applicable Law, collect information and data, including
                                         but not limited to patient-reported outcomes, doctor-reported experiences and registry
                                         data, and shall provide support services useful for Marketing Authorization applications
                                         in the Territory. As a compensation for the collection of such information and data,
                                         and/or the performance of such services, HEMISPHERX will pay to IMPATIENTS a royalty
                                         as further provided in this Clause 7.1.



 


		7.1.1.2	In
                                         the event that HEMISPHERX or any of its Affiliates receives Marketing Authorization in
                                         the Field for the Product in any country in the Territory, then HEMISPHERX shall pay
                                         IMPATIENTS (or its successors or assigns) a royalty of up to a maximum of {***}%
                                         of Net Sales of Product in the countries in the Territory for which Marketing Authorization
                                         is granted. In the event that {***} patients
                                         are entered into the EAP, such royalty percentage shall be calculated in accordance with
                                         the following formula:



 


{***}


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




    	 	 	12



     


    

 


Exhibit
7 sets out a number of worked examples for this calculation.


 


		7.1.2	Royalties
                                         payable in respect of Net Sales shall be payable on a {***}
                                         basis for a period starting from the receipt of Marketing Authorization and ending the
                                         date{***} years from the {***}
                                         of such Product {***}.



 


		7.1.3	HEMISPHERX shall not be entitled
                                         to assign, sell or dispose of its rights in respect of the Product in the Field to a
                                         third party (including granting a third party the right to file for a Marketing Authorization
                                         based on HEMISPHERX’s rights and know how) unless such third party undertakes in
                                         writing to IMPATIENTS to be bound by the provisions of this Clause 7 as if such third
                                         party were a party to this Clause 7 instead of HEMISPHERX. For the avoidance of doubt,
                                         by third party in this Clause 7 is meant any person or entity that is not a Party to
                                         this agreement, including any Affiliate of HEMISPHERX.



 


		7.1.4	For
                                         the purposes of the calculation of the royalty payment under this Clause 7.1, Product
                                         Net Sales shall be reported, and royalties based on such Product Net Sales shall be paid,
                                         to IMPATIENTS within {***} after the end
                                         of each {***}
                                         during which Product has been sold. HEMISPHERX,
                                         its Affiliates, licensees, successors and/or assigns shall maintain accurate records
                                         of Product sales for a period of no less than seven years. Such records may be audited
                                         for accuracy once a year by an independent public accounting firm, acceptable to both
                                         Parties, which accounting firm would be allowed reasonable access at reasonable times
                                         to review all relevant records.



 


			8   – Warranties and Undertakings,
                                         Liability and Indemnity



 


		8.1	Mutual Representations and Warranties.



 


The Parties
represent and warrant and, where relevant, undertake to each other, as of the Effective Date, as follows:


 


		8.1.1	Organization.
                                         



 


It
is a corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization,
and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform this Agreement.


 


		8.1.2	Authorization.
                                         



 


The
execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorized
by all necessary corporate action, and do not violate (a) such Party’s charter documents, bylaws, articles of association
or other organizational documents, (b) any material respect, any agreement, instrument, or contractual obligation to which such
Party is bound, (c) any requirement of any Applicable Law, or (d) any order, writ, judgment, injunction, decree, determination,
or award of any court or governmental agency presently in effect applicable to such Party.


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 


 




    	 	 	13



     


    

 


 


		8.1.3	Binding
                                         Agreement. 



 


This
Agreement is a legal, valid, and binding obligation of such Party, enforceable against it in accordance with its terms and conditions,
subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights,
judicial principles affecting the availability of specific performance, and general principles of equity (whether enforceability
is considered a proceeding at law or equity).


 


		8.1.4	No
                                         Inconsistent Obligation. 



 


It
is not under any obligation, contractual or otherwise, to any person that conflicts with or is inconsistent in any material respect
with the terms of this Agreement, or that would impede the diligent and complete fulfillment of its obligations hereunder.


 


		8.2	Product Warranty and Undertaking.



 


HEMISPHERX warrants and undertakes
that all Product supplied to IMPATIENTS under this Agreement shall comply with the Specifications; be manufactured, filled, finished,
labeled and packed in GMP facilities and in accordance with the Quality Agreement and all Applicable Laws; be free from contamination
or adulteration; be adequately packed to withstand transportation. At the time of delivery, each Product shall have no less than
9 (nine) months of the Product’s registered shelf life remaining.


 


		8.3	Product Liability.



 


HEMISPHERX represents and warrants
to IMPATIENTS that HEMISPHERX is legally bound to retain responsibility and liability for the manufacture of the Product at all
times and undertakes that it shall maintain product and general liability insurance covering any loss, costs, expenses, liability,
actions, demands, claims or proceedings relating to the Product.


 


		8.4	Indemnity.
                                         



 


Each Party shall indemnify and
hold the other Party harmless from any claims, suits, demands, judgments, actions, liabilities, (including strict liability and
infringement of a third party’s patent rights) expenses (including reasonable attorney’s fees) and damages relating
to the Product and caused directly or indirectly by any act or omission of the other Party and its officers, directors,
employees, subcontractors, agents or suppliers, or (in the case of HEMISPHERX only) the Manufacturer. This indemnity shall
not apply if any such liability, loss, damage, cost or expense is due to the gross negligence or default in performance by the
indemnified Party, its officers, directors, employees, subcontractors, agents or suppliers.


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




    	 	 	14



     


    

 


		8.5	Waiver
                                         of consequential or punitive damages.



 


Save as for intentional wrongdoing
by a Party, neither Party, nor any of their respective directors, officers, employees or agents shall have any liability towards
the other Party, for any indirect or consequential damages claimed by the other Party, including, but not limited to the loss
of opportunity, loss of use, and/or loss of revenue or profit, in connection with or arising out of this Agreement or breach thereof.


 


		8.6	Insurance



 


Each Party shall maintain at its
own cost at all times during the term of this Agreement, policies of insurance in such amounts and to cover such risks as are
reasonable, prudent and/or potentially foreseeable hereunder. Maintenance of such insurance coverage will not relieve a Party
of any responsibility under this Agreement for damages in excess of insurance limits or otherwise.


 


			9   - Confidentiality



 


		9.1	The Parties will continue to abide
                                         by the confidentiality agreement signed by both Parties dated 11 June 2015, provided
                                         that the term of the confidentiality agreement shall be extended as long as necessary
                                         so as not to expire before the expiration or termination of this Agreement. The
                                         terms of confidentiality respecting Information shall not impede the appropriate use
                                         thereof in IMPATIENTS’s submission of Information in Early Access Approvals applications
                                         with Regulatory Authorities, in HEMISPHERX’s submission of Information in Marketing
                                         Authorization Applications with Regulatory Authorities, or in execution of the EAP of
                                         Product according to the EAP Plan.



 


		9.2	HEMISPHERX acknowledges that the EAP
                                         Plan involves the publication of safety and efficacy information relating to the Product,
                                         including HEMISPHERX Confidential Information included in the Regulatory Documentation,
                                         and the patient- and doctor-reported outcomes and registry data generated and collected
                                         during the performance of the EAP. Therefore, HEMISPHERX hereby consents to IMPATIENTS
                                         publishing such HEMISPHERX’s Confidential Information as is required in accordance
                                         with Applicable Laws.



 


		9.3	HEMISPHERX and IMPATIENTS agree to
                                         use all Confidential Information received under this Agreement solely for the purpose
                                         set forth herein and agree not to otherwise interfere in the business of the other in
                                         any respect.



 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




    	 	 	15



     


    

 


			10   - Duration, termination



 


		10.1	This
                                         Agreement will become legally effective on the Effective Date and, unless earlier terminated
                                         pursuant to the terms hereof, shall continue in full force and effect for an initial
                                         period of {***} years. This initial period
                                         may be extended upon mutual written agreement between the Parties and in the absence
                                         of a notice to the other Party (to be given with at least 90 days notice) from a Party
                                         that it does not agree to the extension of this Agreement under this Clause 10.1, shall
                                         be extended each anniversary by 12 months until commercial availability of the Product
                                         in the Territory following receipt by HEMISPHERIX or one of its Affiliates of appropriate
                                         Marketing Authorization. 



 


		10.2	Subject to any mandatory provision
                                         of law, this Agreement may be terminated by a Party, without any liability to the other,
                                         if the other Party is dissolved or liquidated, files or has filed against it a petition
                                         under any applicable bankruptcy or insolvency law, makes a general assignment for the
                                         benefit of its creditors, or has a receiver appointed for substantially all of its assets.



 


		10.3	Following
                                         expiry of the initial {***}-year term as
                                         set out in Clause 10.1, either Party may terminate this Agreement, provided the non-terminating
                                         Party is provided with 6 (six) months written notification.



 


		10.4	HEMISPHERX shall have the right to
                                         terminate this agreement at any time during the Term provided that it shall provide IMPATIENTS
                                         with ninety (90) days written notification.



 


		10.5	In the event that HEMISPHERX does
                                         not provide notification of ability to supply the Product for the EAP under Clause 6.2
                                         within twelve (12) months of the Effective Date, IMPATIENTS shall be entitled to terminate
                                         this Agreement with thirty (30) days written notification.



 


		10.6	Each Party reserves the right to immediately
                                         terminate this Agreement if the other Party is in breach of its material obligations
                                         under this Agreement and fails to remedy such breach within 6 (six) months written notification
                                         by the other Party of said breach. In the event of a breach not being capable of remedy
                                         within 6 (six) months of written notification, the parties shall negotiate in good faith
                                         to agree a period for remedy after which, if the breach remains, the Party whose obligations
                                         are not in such continuing breach shall be entitled to terminate this Agreement.



 


		10.7	Consequences of Termination.



 


		10.7.1	In the event of a termination of
                                         this Agreement under Clauses 10.1 to 10.5 (inclusive), HEMISPHERX shall permit IMPATIENTS
                                         to continue to distribute and sell the Product until such time that the entire quantity
                                         of the Consignment Stock has been sold.



 


		10.7.2	In
                                         the event of termination of this Agreement pursuant to Clause 10.1, termination by HEMISPHERX
                                         pursuant to Clause 10.3 or by IMPATIENTS pursuant to Clause 10.5, Clause 7.1 shall
                                         survive such termination and the royalty rate to be applied to Net Sales of Product shall
                                         be the percentage as calculated in accordance with such Clause 7.1{***}.



 


		10.7.3	In the event of termination of this
                                         Agreement by HEMISPHERX pursuant to Clause 10.4, Clause 7.1 shall survive such termination
                                         and the royalty rate to be applied to Net Sales of Product shall be set according to
                                         the Termination Algorithm outlined in Exhibit 7.



 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




    	 	 	16



     


    

 


		10.7.4	Upon termination of this Agreement
                                         by IMPATIENTS pursuant to Clause 10.3 or by HEMISPHERX pursuant to Clauses 10.5 or 10.6,
                                         Clause 7.1 shall not survive termination and no royalty shall be payable to IMPATIENTS
                                         under such provision.



 


		10.8	Survival.



 


In addition to and subject to
the provisions of Clause 10.6, Clause 1, Clauses 4.5.1 and 4.5.2, Clause 6.5 and Clauses 8 to 11 shall survive termination of
this Agreement.


 


			11   – Miscellaneous



 


		11.1	Entire Agreement.



 


This Agreement, together with
the Confidentiality Agreement dated 11 June 2015 and signed by the Parties prior to the Effective Date, constitutes the entire
agreement between the Parties as regards the Product, and any former agreement relating to the same subject matter hereby becomes
null and void. In the event of any inconsistencies between the terms of these Agreements, the terms of this Agreement shall prevail.


 


		11.2	Amendments.



 


Modifications to this Agreement
shall be made in writing only, and shall only take effect when signed by both Parties.


 


		11.3	Press releases



 


Each Party shall have the right
to disclose the existence of this Agreement, but not any of its material terms (which shall remain Confidential Information of
both Parties), provided that such disclosing Party shall provide to the other Party the proposed text of any press release for
review not less than five (5) days prior to public disclosure.


 


		11.4	Independent Contractors.



 


It is understood that both Parties
hereto are independent contractors and engage in the operation of their own respective businesses. Neither Party hereto is to
be considered the agent of the other Party for any purpose whatsoever, and neither Party has any authority to enter into any contract
or assume any obligation for the other Party or to make any warranty or representation on behalf of the other Party. Each Party
shall be fully responsible for its own employees, servants and agents, and the employees, servants and agents of one Party shall
not be deemed to be employees, servants and agents of the other Party for any purpose whatsoever.


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




    	 	 	17



     


    

 


		11.5	Remedy; Waiver.



 


Exercise by any Party of any
of its rights under this Agreement shall not be deemed to limit any other right or remedy that such Party may have in law or equity.
The waiver by either Party of a breach of any of the provisions of this Agreement by the other Party shall not be construed as
a waiver of any succeeding breach of the same or other provisions, nor shall any delay or omission by either Party in exercising
any right that it may have under this Agreement operate as a waiver of any breach or default by the other Party.


 


		11.6	Formalities.



 


Each Party agrees to execute
deliver and/or do such further papers, agreements or acts as may be necessary or desirable to give effect to this Agreement and
its purpose and to carry out its provisions.


 


		11.7	Choice of Law and Dispute
                                         Resolution.



 


This Agreement shall be governed
by and interpreted under the laws of the Netherlands. All disputes arising out of or in connection with this Agreement shall be
submitted to the International Court of Arbitration of the International Chamber of Commerce and shall be finally settled under
the Rules of Arbitration of the International Chamber of Commerce by three arbitrators appointed in accordance with the said Rules.
Any such arbitration shall take place in Amsterdam, the Netherlands and in the English language.


 


		11.8	Language.



 


This Agreement is executed in
the English language. The language used in this Agreement shall be deemed to be the language chosen by the Parties hereto to express
their mutual intent and no rule of strict construction against either Party shall apply to any term or condition of this Agreement.
The definitive language of this Agreement is English and no reliance shall be placed upon any translation into any other language.


 


		11.9	Assignment; Assumption.



 


Subject to the provisions of
Clause 7.1.3, neither this Agreement nor any rights or obligations hereunder may be assigned or duties delegated (other than specified
in the EAP Plan) by either Party without the prior written consent of the other Party, which consent shall not be unreasonably
withheld. Any assignment in violation of this clause shall be null and void. Any permitted assignee shall, upon the request of
the other Party hereto, expressly acknowledge, by written agreement, its assumption of all obligations and liabilities under this
Agreement.


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




    	 	 	18



     


    

 


		11.10	Force Majeure.



 


Should a Party be unable to perform
any of its obligations under this Agreement due to an event of force majeure as determined by law such Party shall be excused
to perform its obligation during the period of such force majeure event provided always that it gives the other Party prompt written
notice of such force majeure event. If the event of force majeure were to prevent such Party performing its obligations in connection
with this Agreement for a continuous period of more than three (3) months, the other Party may terminate the Agreement at its
sole option by giving written notice thereof, without any indemnity to be paid by either Party. The termination would then take
effect without further notice, at the date of receipt of the above notice. In no event shall this provision relieve either Party
of its obligation to make payment when owing.


 


		11.11	Severability.



 


If any provision of this Agreement
is found to be invalid or unenforceable by any court or administrative body of competent jurisdiction, then the invalidity or
unenforceability of such provision shall not affect the other provisions of this Agreement, and all provisions not affected by
such invalidity or unenforceability shall remain in full force and effect. The Parties agree to attempt to substitute for any
invalid or unenforceable provision a valid or enforceable provision, which achieves to the greatest extent possible the economic
objectives of the invalid or unenforceable provision. If any provision of this Agreement conflicts with applicable legislation,
then the Parties shall modify such provision in order to comply with said legislation. This modification shall not affect the
other provisions of this Agreement.


 


		11.12	Notice.



 


All formal notices to be given
pursuant to this Agreement shall be in writing and in English and shall be delivered by hand, sent by registered mail return receipt,
or by express courier service to the address of the Party to receive such notice as set out below (or such other address as may
be notified by a Party to the other from time to time). Notices shall be deemed to have been received at the time of delivery
by hand, at the date affixed on the return receipt or 3 (three) business days after sending if sent by express courier service.


 


	For
    HEMISPHERX:	For
    IMPATIENTS:
	 	 
	HEMISPHERX:	Impatients N.V.:
	Attn: Thomas Equels	Attn.: {***}
	1617 JFK Boulevard	Pilotenstraat 45
	Suite 500	1059 CH
	Philadelphia, Pa. 19013	Amsterdam
	 	The Netherlands
	 	Email:
    {***}


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




    	 	 	19



     


    

 


		11.13	Construction. 



 


Except where the context otherwise
requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable
to all genders and the word “or” is used in the inclusive sense (and/or). Whenever this Agreement refers to a number
of days, unless otherwise specified, such number refers to calendar days. The captions of this Agreement are for convenience of
reference only and in no way define, describe, extend, or limit the scope or intent of this Agreement or the intent of any provision
contained in this Agreement. The term “including,” “include,” or “includes” as used herein
shall mean “including, but not limited to,” and shall not limit the generality of any description preceding such term.
The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction
shall be applied against either Party hereto. Each Party represents that it has been represented by legal counsel in connection
with this Agreement and acknowledges that it has participated in the drafting hereof. In interpreting and applying the terms and
provisions of this Agreement, the Parties agree that no presumption will apply against the Party which drafted such terms and
provisions.


 


IN WITNESS WHEREOF, the Parties
have executed this Agreement by their respective, duly authorized, representatives:


 


	For
    HEMISPHERX: 	 	For
    IMPATIENTS:
	 	 	 
	s/Thomas Equels	 	s/Ronald Brus
	Thomas Equels	 	Ronald
    Brus
	CEO	 	CEO


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




    	 	 	20



     


    

 


Exhibit 1. – EAP Plan 


 


(to be inserted after being agreed by
JSC)


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 


 




    	 	 	21



     


    

 


Exhibit 2 – JSC and subcommittees


 


		1	JSC.



 


		1.1	Composition.



 


The
JSC shall consist of{***}, each with the requisite experience and seniority to enable
such person to make decisions on behalf of a Party with respect to the issues falling within the jurisdiction of the JSC. From
time to time, each Party may substitute one or more of its representatives to the JSC on written notice to the other Party. {***}.
The chairperson shall appoint a secretary of the Joint Steering Committee, who shall be {***}.


 


		1.2	Specific Responsibilities.



 


The JSC shall oversee the EAP
for the Product in the Territory, and shall serve as a forum for the coordination of activities for the Product for the Territory.
In particular, the JSC shall:


 


		(a)	periodically
                                         (no less often than annually) review and serve as a forum for discussing the EAP, and
                                         review and approve amendments thereto;



		(b)	oversee
                                         the conduct of EAP activities;



		(c)	serve
                                         as a forum for discussing and coordinating strategies for obtaining Early Access Approvals
                                         and Regulatory Approvals for the Product in the Territory;



		(d)	establish
                                         secure access methods (such as secure databases) for each Party to access Regulatory
                                         Documentation and other JSC related Information as contemplated under this Agreement;
                                         and



		(e)	perform
                                         such other functions as are set forth herein or as the Parties may mutually agree in
                                         writing, except where in conflict with any provision of this Agreement.



		(f)	Approve
                                         HEMISPHERX Know-How and Regulatory Documentation to be shared with Regulatory Authorities
                                         and physicians both under relevant confidentiality mechanisms.



 


		1.3	Disbandment.
                                         



 


Upon
Marketing Authorization of the Product in all countries of the Territory, unless otherwise mutually agreed in writing, the JSC
shall have no further responsibilities or authority under this Agreement and will be considered dissolved by the Parties. 


 


		1.4	Subcommittees.
                                         



 


From
time to time, the JSC may establish and delegate duties to sub-committees or directed teams (“Subcommittees(s)”) on
an “as-needed” basis to oversee particular projects or activities (for example, joint project team, joint finance
group, and/or joint intellectual property group). Each such Subcommittee shall be constituted and shall operate as the JSC determines;
provided that each Subcommittee shall have equal representation from each Party, unless otherwise mutually agreed. Subcommittees
may be established on an ad hoc basis for purposes of a specific project or on such other basis as the JSC may determine.
Each Subcommittee and its activities shall be subject to the oversight, review and approval of, and shall report to, the JSC.
In no event shall the authority of the Subcommittee exceed that specified for the JSC. All decisions of a Subcommittee shall be
by unanimous agreement.


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




    	 	 	22



     


    

 


		2	General Provisions Applicable to committees.



 


		2.1	Meetings and Minutes.



 


The committees shall meet quarterly
by telephonic or tele video means, or, when necessary as agreed between the Parties, face-to-face, with the location of such face-to-face
meetings alternating between locations designated by HEMISPHERX and locations designated by IMPATIENTS. The chairperson of the
applicable committee shall be responsible for calling meetings on no less than thirty (30) Business Days’ notice. Each Party
shall make all proposals for agenda items and shall provide all appropriate information with respect to such proposed items at
least ten (10) Business Days in advance of the applicable meeting; provided that under exigent circumstances requiring
input by the committee, a Party may provide its agenda items to the other Party within a shorter period of time in advance of
the meeting, or may propose that there not be a specific agenda for a particular meeting, so long as the other Party consents
to such later addition of such agenda items or the absence of a specific agenda for such meeting, such consent not to be unreasonably
withheld or delayed. The chairperson of the committee shall prepare and circulate for review and approval of the Parties minutes
of each meeting within thirty (30) days after the meeting. The Parties shall agree on the minutes of each meeting promptly, but
in no event later than the next meeting of the committee. If the Parties cannot agree on the content of the minutes the objecting
party shall append a notice of objection with the specific details of the objection to the proposed minutes.


 


		2.2	Procedural Rules.



 


Each committee shall have the
right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with
this Agreement. A quorum of the committee shall exist whenever there is present at a meeting at least one (1) representative appointed
by each Party. Representatives of the Parties on a committee may attend a meeting either in person or by telephone, video conference
or similar means in which each participant can hear what is said by, and be heard by, the other participants. Representation by
proxy shall be allowed. Each committee shall take action by unanimous agreement of the representatives present at a meeting at
which a quorum exists, with each Party having a single vote irrespective of the number of representatives of such Party in attendance,
or by a written resolution signed by at least one (1) representative appointed by each Party. Employees or consultants of either
Party that are not representatives of the Parties on a Committee may attend meetings of such committee; provided, however,
that such attendees (a) shall not vote or otherwise participate in the decision-making process of the Committee, and (b) are
bound by obligations of confidentiality and non-disclosure equivalent to those set forth in Section 11.1 of the Agreement.


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




    	 	 	23



     


    

 


		2.3	Committee Dispute Resolution.



 


If a subcommittee cannot, or
does not, reach unanimous agreement on an issue at a meeting or within a period of ten (10) Business Days thereafter or such other
period as the Parties may agree, then the dispute shall be referred to the JSC for resolution and a special meeting of the JSC
may be called for such purpose. If the JSC cannot, or does not, reach unanimous agreement on an issue, including any dispute arising
from the JSC, then the dispute shall first be referred to the senior officers of the Parties, who shall confer in good faith on
the resolution of the issue. Any final decision mutually agreed to by the senior officers shall be conclusive and binding on the
Parties.


 


		2.4	Limitations on Authority.



 


Each Party shall retain the
rights, powers, and discretion granted to it under this Agreement and no such rights, powers, or discretion shall be delegated
to or vested in a committee unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties
expressly so agree in writing. No committee shall have the power to amend, modify, or waive compliance with this Agreement, which
may only be amended or modified as provided in Section 11.2 of the Agreement.


 


		2.5	Alliance Manager.



 


Each Party shall appoint a person(s)
who shall oversee contact between the Parties for all matters between meetings of each committee and shall have such other responsibilities
as the Parties may agree in writing after the Effective Date (each, an “Alliance Manager”). Each Party may replace
its Alliance Manager at any time by notice in writing to the other Party.


 


		3	Discontinuation of Participation on
                                         a Committee.



 


Each committee shall continue
to exist until the first to occur of: (i) the Parties mutually agreeing to disband the committee; or (ii) upon receipt
of Marketing Authorization of the Product in the last country of the Territory.


 


		4	Expenses.



 


Each Party shall be responsible
for all travel and related costs and expenses for its members and other representatives to attend meetings of, and otherwise participate
on, a committee.


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 


 




    	 	 	24



     


    

 


Exhibit 3 – Trademark usage conditions


 


		1.	Product Trademark License Terms.



 


		1.1.	IMPATIENTS acknowledges HEMISPHERX’s
                                         exclusive right, title, and interest in and to the Product Trademarks and acknowledges
                                         that (i) neither this Agreement, nor its use of the Product Trademarks hereunder, shall
                                         be construed to accord to IMPATIENTS any rights in the Product Trademarks other than
                                         the limited license rights granted herein, and (ii) the goodwill generated thereby will
                                         inure solely and entirely to the benefit of HEMISPHERX.



 


		1.2.	Should it be necessary to record
                                         IMPATIENTS as a registered licensee of the Product Trademarks in any jurisdiction, HEMISPHERX
                                         shall do so at IMPATIENTS's expense, and IMPATIENTS will cooperate with HEMISPHERX to
                                         effect such recordation.



 


		2.	Trademark Use.



 


IMPATIENTS may use the Product
Trademarks solely in conjunction with the Product EAP.


 


		2.1.	Product Trademarks Usage Requirements.



 


IMPATIENTS agrees to comply
with the Product Trademarks usage requirements of this Exhibit 2.1.


 


		2.2.	The Product Trademarks may not
                                         be used in connection with the display, advertising, or promotion of Product for any
                                         purpose IMPATIENTS has not been appointed for.



 


		2.3.	The Product Trademarks may not
                                         to be altered. The Product Trademarks are not to be used in conjunction with any other
                                         mark or design, i.e., the Product Trademarks must stand alone in terms of the commercial
                                         impression generated by the particular usage; provided, however, that IMPATIENTS’s
                                         trademarks may be used along with the Product Trademarks as long as such trademarks do
                                         not combine, superimpose or overlap with the Product Trademarks.



 


		2.4.	IMPATIENTS must exercise care
                                         in the use of the Product Trademarks so as not to indicate to the public that IMPATIENTS
                                         is a division or affiliate of HEMISPHERX or otherwise related to HEMISPHERX.



 


		2.5.	IMPATIENTS shall not use as its
                                         own trademark any word(s) or design(s) confusingly similar to the Product Trademarks.



 


		3.	Protection of Interest.



 


If IMPATIENTS becomes aware of any unauthorized
use of the Product Trademarks by a third party, IMPATIENTS, subject to its confidentiality obligations to other parties, agrees
to promptly notify HEMISPHERX and to cooperate fully, at HEMISPHERX's expense, in the enforcement of HEMISPHERX's rights against
such a third party. Nothing contained in this Section shall be construed as to require HEMISPHERX to enforce any rights against
a third party or to restrict HEMISPHERX's rights to license or consent to such a third party's use of the Product Trademarks.


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




    	 	 	25



     


    

 


Exhibit 4 – Price of Product


 


Product Price to be invoiced by IMPATIENTS
to third parties (excluding VAT):


 


USD {***}
for a {***} course of treatment of {***}
vials {***}. Meaning{***}
vials in total, with an equivalent price of USD {***} per vial 


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




    	 	 	26



     


    

 


Exhibit 5 - Quality Agreement


 


(to be inserted after being agreed by
JSC)


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 




    	 	 	27



     


    

 


Exhibit 6 -Pharmacovigilance
Agreement


 


(to be inserted after being agreed by
JSC)


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


  




    	 	 	28



     


    

 


Exhibit 7 –Royalty
Payment Example Calculations


 


For the purposes of illustration of the calculation
of the royalty payments under Clause 7.1, the formula(s) would be calculated in the following situations as follows:


 


{***}


 


This demonstrates
that if, during the course of the EAP, {***} patients have been admitted to the EAP
the maximum royalty percentage will have been reached.


 


In the event of termination of this Agreement
by HEMISPHERX pursuant to Clause 10.4, Clause 7.1 shall survive such termination and the royalty rate to be applied to Net Sales
of Product shall be set according to the following Termination Algorithm:


 


If Hemispherx terminates without cause:


 


Royalty Rate on Hemispherx Commerical
Sales As a Function of EAP Performance and Time


 


Cumulative EAP Patients    >6
mos <1 year    >1 yr <2 yrs    >2 yrs <3yrs    >3
yrs <4 yrs    >4 yrs <5 yrs


 


{***}


 


For the
avoidance of doubt, where the Termination Algorithm matrix above provides that, on termination by Hemispherx in accordance with
clause 10.4, the royalty rate shall be calculated in accordance with the formula, then such formula shall be the formula set out
in Clause 7.1 {***}.


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


  




    	 	 	29



     


    

 


Exhibit 8 –List
of Deductions


 


Trade discounts or rebates, mutually agreed
between the Parties


 


Amounts reserved for claims, allowances or
credits connected with rejections or returns of Product


 


Packaging, handling fees and costs of
freight, insurance, sales taxes duties and other governmental charges (which sums shall include value added tax and its equivalents,
but shall not include income taxes)


 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


 


 




    	 	 	30



     


    

Exhibit 9 – Data
to be collected


 


To the extent permitted by Applicable
Law, IMPATIENTS shall use it reasonable commercial efforts to collect the following data in relation to the EAP:


 


		1)	Patient completed SF-36 questionnaire
                                         and Karnofsky Performance questionnaire every 8 weeks



 


		2)	Physician’s Karnofsky performance
                                         score (based on patient questionnaire) every 8 weeks.



 


		3)	Physician completed
                                         Chronic Fatigue Syndrome questionnaire



 


		4)	Safety / adverse
                                         events in accordance with the Pharmacovigilance Agreement



 


{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 


  








    	 	 	31