Exhibit 10.1


 


 


 


Sales,
Marketing, Distribution, and Supply Agreement {***}


 


WHEREAS HEMISPHERX is a biopharmaceutical company with headquarters
at One Penn Center, 1617 JFK Boulevard, Suite 500, Philadelphia, PA 19103, U.S. ("HEMISPHERX") and Scientific
Products Pharmaceutical Co. LTD is a pharmaceutical company with its primary offices located at Tahlia Street, P.O Box 10485,
Riyadh 11433 Saudi Arabia (" SCIEN”), each a “Party” together, “Parties”, and


 


WHEREAS HEMISPHERX owns intellectual proprietary rights relating
to Interferon alfa-n3 (human leukocyte derived), and


 


WHEREAS HEMISPHERX desires to have Interferon alfa-n3 (human
leukocyte derived) provided to physicians to treat genital warts and other infections and diseases, including MERS, in the GCC
(Gulf Cooperation Council) states , as appropriate, prior to regulatory approval in such countries and to have Interferon alfa-n3
(human leukocyte derived) approved by the regulatory authorities in each GCC country (Kingdom of Saudi Arabia, Bahrain, Qatar,
Kuwait, United Arab emirates (UAE) and Sultanate of Oman)), and


 


WHEREAS SCIEN has sales, marketing, distribution capabilities
in the GCC states, and


 


WHEREAS, AFTER A SUCCESSFUL CLINICAL TRIAL IN MERS, SCIEN affirms
it has the ability to supply Interferon alfa-n3 (human leukocyte derived) in the GCC States prior to regulatory approval and simultaneously
seek to gain regulatory approval in each of the GCC States. After the clinical trial in MERS has been conducted, in the event
it is successful and the Hemispherx manufacturing site requires approved by the GCC / SFDA, the cost of any post-clinical trial
inspection of the facility to be the responsibility of Scien or the regulatory authority, and subsequently to market, sell and
distribute Interferon alfa-n3 (human leukocyte derived) in the GCC, and


 


WHEREAS, SCIEN desires to supply Interferon alfa-n3 (human
leukocyte derived) under special approval from the Saudi Ministry of Health and for other GCC states where applicable, and


 


WHEREAS, HEMISPHERX desires to supply and sell Interferon alfa-n3
(human leukocyte derived)) to SCIEN, and SCIEN is willing to purchase Interferon alfa-n3 (human leukocyte derived) from HEMISPHERX
for the purposes described in this agreement.


 


NOW THEREFORE, in consideration of the mutual covenants and
agreements made herein, and for other good and valuable consideration, the receipt of which is hereby acknowledged, the Parties
agree as follows:


 


I.           DEFINITIONS


 


"Affiliate" means any corporation or other business
entity, which controls, is controlled by, or is under the common control of a Party.


 


"End User" means a physician, medical facility or
institution, or government agency that purchases Product with the intent of administering it to a patient.


 


"Field" means refractory/recurrent genital warts,
recombinant interferon refractory patients and patients with other infectious diseases, e.g., MERS, influenza, West Nile Virus,
and cancer, etc.


 


"HEMISPHERX Intellectual Property" means all HEMISPHERX
patents, patent applications, know-how, and trademarks owned or controlled by HEMISPHERX up to the termination or expiration of
this Agreement.


 


“List Price” means ${***}/Product Unit.


 


“Product” means an injectable formulation of clinical
grade Interferon alfa-n3 (human leukocyte derived).


 


{***} 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.


 




    	 	Page 1 of 28	 



     


    

 


"Product Data" means all data possessed by HEMISPHERX
relating to the use of Interferon alfa-n3 (human leukocyte derived) to treat patients in the Field and which is needed to obtain
regulatory approval in the Territory.


 


"Product Unit" means 1 x1ml vial containing 5 million
international units (I.U.) of Interferon alfa-n3 (human leukocyte derived)


 


"Sales Price" means the price SCIEN and/or its Affiliates
charge an End User for a Product Unit.


 


"Territory" means the GCC States


 


“Transfer Price” means
a discounted price of ${***}/ Product Unit. 


 


II.          LICENSE



 


CONDITION PRECEDENT: THE GRANTING OF ANY AND ALL LICENSES
OR PRIVILEGES HEREIN IS SUBJECT TO THE SUCCESSFUL COMPLETION OF A FIVE PERSON MINIMUM CLINICAL TRIAL IN THE KINGDOM OF SAUDI
ARABIA TREATING EARLY ONSET PATIENTS INFECTED WITH MERS.


 


A.           Subject
to the condition above, HEMISPHERX hereby grants SCIEN the exclusive license to sell, market, and distribute Product for use
in the Field in the Territory for Direct Access/EAP and Regulatory Agency-Approved (RAA) purposes.


 


B.           SCIEN
shall not use HEMISPHERX Intellectual Property nor sell nor permit the sale of any products that use the HEMISPHERX Intellectual
Property outside the Territory or knowingly sell or have sold any products that use the HEMISPHERX Intellectual Property to any
party in or outside the Territory for export or sale outside the Territory, without HEMISPHERX's prior written consent.


 


C.           SCIEN
will have six 6) months after the date of this Agreement to Purchase at least 50 vials to be used by the MOH in treating patients
with MERS. Scien will thereafter, based on the outcome of the initial treatment for MERS by the MOH trial, aggressively promote
to all stakeholders in Saudi Arabia and the other GCC states (“First Performance Milestone”).


 


III.         COMMERCIAL
DEVELOPMENT


 


A.          HEMISPHERX has or will provide SCIEN:


 


1.          As
an Integral Part of this Agreement and in order for HEMISPHERX to ship Product to SCIEN, the letter with attachments (Exhibit
1) must be signed by an officer of SCIEN. A protocol is also provided (Exhibit 2).


 


2.          All
the appropriate information about Products that will assist with the education of physicians about the Product in the Territory.


 


3.          Ongoing
scientific and medical support.


 


4.          Product
Units in quantities sufficient for SCIEN's Direct Access/EAP and RAA commercial needs in the Territory, subject to availability
from HEMISPHERX.


 


{***} 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.


 




    	 	Page 2 of 28	 



     


    

 


B.           SCIEN
will:


 


1.
         Within 60 days after this Agreement becomes effective, prepare and
provide a Business Plan, to be attached to this Agreement as Exhibit 3, to make aware and educate physicians and patients about
Product both prior to and following approval of Product.


 


2.          Assist
in determining reimbursable End User pricing of Product and gain reimbursement for Product under Direct Access/EAP program and
RAA sales of the Product in the Territory.


 


3.          Assist
physicians who desire to administer Product with the required paperwork under any Direct Access/EAP program.


 


4.          Manage
the logistics within the Territory from arrival to End User supply.


 


6.          Assist
HEMISPHERX to gain regulatory approval of Product in the Field in the Territory


 


7.          Prepare
and provide a 3-year post regulatory approval Sales, Marketing, and Distribution Plan including a 3-year minimum sale forecast
and a committed-dollar field sales force, product manager and marketing budget to be agreed by both Parties and a non-binding
12 month Product forecast no later than six (6) months prior to the anticipated registration and subsequent launch date for each
Product, also to be agreed by both parties,


 


8.          Pay
for all the above Sales Marketing and Distribution activities and related expenses.


 


9.          Hold
3 months inventory of the forecasted sales once the product is registered.


 


10.         If
needed, assist in recruiting clinical trial sites and principal investigators in the Field in the Territory.


 


11.         Provide
HEMISPHERX a monthly written report of SCIEN's efforts and status thereof under this Agreement.


 


IV.          SUPPLY


 


A.           Subject
to the terms and conditions of this Agreement, HEMISPHERX agrees to exclusively supply Product to SCIEN in the Territory with
a minimum expiry of 6 months from the date of shipment.


 


B.           The
price that SCIEN will pay for Product under this Agreement is the Transfer Price, CIF. Taxes, duties, and other expenses to be
paid by SCIEN.


 


C.           SCIEN
shall pay HEMISPHERX for each order of Product within 75 days after receipt of the goods except for the for first purchase order
which will be for 50 vials of Interferon alfa-n3 (human leukocyte derived) (“First Order”) and paid once the MOH approves
the use for Interferon alfa-n3 (human leukocyte derived) on 5 MERS patients. All purchase orders are final.


 


D.           SCIEN
will ensure all necessary QA testing / approval for use occurs in the Territory and that each Product is stored under the conditions
stipulated in a Quality Agreement (QA) to be executed and appended to this Agreement as Exhibit 4.


 


E.           Forecasts,
Orders, Payment, and Delivery.


 


Direct Access/EAP Distribution


 


Following the signing of this Agreement, SCIEN will start a
full and comprehensive market analysis of the potential of each Product for Direct Access/ EAP distribution. This will be from
a market potential and willingness to pay point of view and will be completed within 3 months of the signature of this Agreement.
A forecast will then be provided for Product for Direct Access/ EAP distribution and this will be added as a supplement to the
Business Plan (Exhibit 3).


 


{***} 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.


 




    	 	Page 3 of 28	 



     


    

 


RAA Distribution 


 


Six (6) months prior to the estimated regulatory approval for
commercial sale of Product in each country in the Territory:


 


1.
         SCIEN will provide HEMISPHERX a rolling 12-month forecast of
the estimated sales of Product Units, the first 3 months of which will be firm and the second three (3) months of which cannot
vary by more than 25% when these become the first three (3) months. This forecast will be updated at 3-month intervals thereafter.


 


2.
         In accordance with this forecast, SCIEN agrees to order Product
from HEMISPHERX under this Agreement by submitting to HEMISPHERX written purchase orders specifying the quantity, packaging, delivery
dates, and delivery location.


 


3.
         HEMISPHERX shall manufacture Product as described in the purchase
order from SCIEN and HEMISPHERX shall make all shipments to the location specified on SCIEN's purchase order as follows:


 


4.
         Hemispherx shall pack, mark and ship Products in accordance with
temperature thermometer specifications for the drug product. Hemispherx shall package Products so as to prevent damage or deterioration
and shall comply with all applicable temperature and packaging laws. Unless otherwise stipulated, Products shall be packaged,
marked, crated and otherwise prepared in accordance with HEMISPHERX's current packaging and crating practices, and good commercial
practices.


 


5.
         SCIEN will prominently display on all Product that the Product
is a product of HEMISPHERX and be so noted and on a visible surface thereof and/or on tags, labels, manuals, and other materials
with which Product is sold, the fact that the Product is manufactured and supplied to SCIEN by HEMISPHERX for use and/or sale
in the Territory shall be clearly displayed.


 


F.           If,
for any reason, at any time, HEMISPHERX shall be unable, or should reasonably anticipate being unable to deliver any part or all
of the ordered Product in accordance with the terms hereof or the accompanying purchase order, HEMISPHERX shall notify SCIEN of
such inability at the earliest possible time (but no later than five (5) workings after HEMISPHERX becomes aware of this their
inability to supply Product, whereupon HEMISPHERX and SCIEN will devise a plan to manage the situation.


 


		G.	HEMISPHERX warrants that the Product (i) shall conform to
                                         the specifications set out in the SCIEN purchase order for Product and (ii) shall meet
                                         all, if any, reasonably applicable regulatory requirements in the Territory once Product
                                         is approved. In the Direct Access/ EAP setting, the Product that HEMISPHERX supplies
                                         must confirm with all manufacturing and regulatory requirements (including labelling)
                                         for the country in which said Product is intended to be sold. SCIEN's acceptance of the
                                         Product shall relieve HEMISPHERX from the obligations arising from this warranty



 


		H.	SCIEN shall have the right to return and demand replacement
                                         of any Product which violates this warranty.



 


		I.	HEMISPHERX and/or SCIEN shall have the right to cancel, without
                                         further obligation to the other party, one or more orders for Product(s) if HEMISPHERX's
                                         or SCIEN's business is interrupted because of an event of force majeure beyond the control
                                         of HEMISPHERX or SCIEN.



 


		J.	HEMISPHERX shall permit SCIEN or its agent, at SCIENs' expense,
                                         to conduct periodic audits of HEMISPHERX's Quality System and Manufacturing records relating
                                         to HEMISPHERX's performance under this Agreement. The audits shall be conducted upon
                                         reasonable advance notice during regular business hours at HEMISPHERX's principal office
                                         and in such a manner as not to unduly interfere with HEMISPHERX's operations.



 


{***} 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.


 




    	 	Page 4 of 28	 



     


    

 


		K.	SCIEN will provide HEMISPHERX with copies of Product specification
                                         sheets, Product inserts, user manuals, user bulletins, and user Product updates and any
                                         other customer materials such as brochures, educational materials, web pages or other
                                         electronic information relating to SCIEN's efforts to sell, market and distribute Product
                                         under this Agreement at least 10 (ten) days prior to the public release or use of such
                                         information.



 


		V.	REPORTS
                                         AND PAYMENTS



 


		A.	Within 30 days following the end of each calendar quarter
                                         after execution of the Agreement, SCIEN will provide HEMISPHERX with quarterly reports
                                         on the number of Product Units sold and the Sales Price during the preceding three months,
                                         key market place issues and successes, regulatory and reimbursement subjects and revisions
                                         to the sales and marketing plans.



 


		B.	Product (s) will be considered sold by SCIEN on the date
                                         it is shipped or invoiced to an End User, whichever is earlier. All shipping, taxes,
                                         duties and other expenses in the Territory is the responsibility of SCIEN.



 


		C.	Price Increase: Beginning on the second year anniversary
of the signing of this Agreement (“Effective Date”) and on each succeeding anniversary of the Effective Date during
the term of this agreement and in consideration of a varies of economic factors such as for example, costs of labour, costs of
material and costs the price paid by SCIEN for Product(s) shall be renegotiated. Any price increase will need to be justified
by HEMISPHERX. Both parties shall, in good faith, attempt to agree upon a reasonable price increase. In the event agreement cannot
be reached the Agreement shall terminate.



 


		D.	All payments hereunder will be made by SCIEN in United States
                                         Dollars by wire transfer of immediately available funds to an account designated by HEMISPHERX.
                                         The following is wire transfer information:



 


Domestic (U.S.):


{***}




International:


{***}


 


		VI.	TERM/TERMINATION



 


		A.	The Term will be 3 years from Effective Date with an automatic
                                         2 year term extensions unless otherwise advised by one of the Parties.



 


		B.	Termination for breach will include:



 


		1.	Failure to purchase Product and distribute to End Users
as called for in II D.



 


		2.	Failure of SCIEN achieving less than 50% achievement
                                         of the minimum Purchases as in III B.7. for two (2) consecutive years,



 


3.          
Insolvency, or the filing for protection under either Party’s bankruptcy laws. Upon the filing of a petition in bankruptcy,
insolvency or reorganization against or by either Party, or either Party becoming subject to a composition for creditors , whether
by law or agreement, or either party going into receivership or otherwise becoming insolvent (such party hereinafter referred
to as the "insolvent party"), this Agreement may be terminated by the other Party by giving written notice of termination
to the insolvent Party, such termination immediately effective upon the giving of such notice of termination.


 


		C.	Upon the occurrence of a breach or default as to any obligation
                                         hereunder by either Party and the failure of the breaching Party to cure (within thirty
                                         (30) days after receiving written notice thereof from the non-breaching Party) such breach
                                         or default, this Agreement may be terminated by the non- breaching Party by giving written
                                         notice of termination to the breaching Party, such termination being immediately effective
                                         upon the giving of such notice of termination.



 


{***} 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.


 




    	 	Page 5 of 28	 



     


    

 


		D.	In the event this Agreement is terminated by either Party
                                         for any reason whatsoever, HEMISPHERX agrees to reasonable efforts to make Product available
                                         to SCIEN for a period of three (3) months after the termination date at the same Transfer
                                         Price and under the same terms of payment.



 


		E.	In the event of termination of this Agreement, SCIEN will
                                         have the right to complete all contracts for the sale or disposition of Product) under
                                         which SCIEN is obligated on the date of termination, provided SCIEN pays the associated
                                         Transfer Price and provided all such sales or dispositions are completed within three
                                         (3) months after the date of termination. Thereafter, HEMISPHERX shall purchase from
                                         the SCIEN all remaining stock of Product that is of merchantable quality at the same
                                         price as was paid by SCIEN.



 


		VII.	ASSIGNMENT



 


Neither this Agreement nor any rights or obligations or licenses
hereunder may be assigned, pledged, transferred or encumbered by either party without the express prior written approval of the
other party, except that either HEMISPHERX or SCIEN may assign this Agreement to any successor by merger or sale of substantially
all of its business or assets to which this Agreement pertains, without any such consent. Any assignment in violation hereof is
void.


 


		VIII.	AUTHORITY



 


SCIEN and HEMISPHERX each warrant and represent that it has
the full right and power to make the promises set forth in this Agreement and that there are no outstanding agreements, assignments,
or encumbrances inconsistent with the provisions of this Agreement.


 


IX.          EXCEPT
AS EXPRESSLY SET FORTH IN THIS SECTION IX, HEMISPHERX MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESSED OR
IMPLIED, REGARDING THE DEVELOPMENT, VIABILITY, COMMERCIAL OR OTHER USEFULNESS OR SUCCESS OF PRODUCT) AND THAT NO WARRANTY OR REPRESENTATION
THAT ANYTHING MADE, USED, SOLD OR OTHERWISE PRACTICED OR ANY SERVICE PROVIDED UNDER THIS AGREEMENT WILL NOT INFRINGE ANY PATENT,
COPYRIGHT, TRADE SECRET, OR OTHER PROPRIETARY RIGHT, FOREIGN OR DOMESTIC, OF ANY THIRD PARTY AND MAKES NO WARRANTIES OR REPRESENTATIONS
AS TO THE VALIDITY, ENFORCEABILITY OR SCOPE OF ANY HEMISPHERX INTELLECTUAL PROPERTY.


 


		X.	INDEMNIFICATION AND WARRANTIES



 


		A.	INDEMNIFICATION



 


SCIEN and HEMISPHERX (each an "Indemnifying
Party") shall indemnify, defend and hold harmless and the other Party's subsidiaries or affiliates, their agents, directors,
officers, employees and assigns (the "Indemnified Parties") from and against all losses, liabilities, damages, demands
and expenses (including reasonable attorneys' fees and expenses) arising out of, as a result of, or in connection with (i) the
negligent actions of the Indemnifying Party, its employees or any third party acting on behalf of or under authority of the Indemnifying
Party in the performance of this Agreement and/or (ii) the violation of any representation or warranty of Indemnifying Party in
this Agreement. Each Party's obligations under this provision shall be subject to the other Party providing reasonable notice
of any such claim. Each Party shall defend with competent counsel and pay all costs of defence, including attorneys' fees, and
any and all damages and court costs awarded in respect to such claim, action or proceeding regarding the claim of infringement.
The Indemnified Parties agree to permit the Indemnifying Party to defend, compromise, or settle any such claim, action or proceeding
and further agree to provide all available information, and reasonable assistance to enable the other Indemnifying Party to do
so. However, neither party will be liable under this indemnity for any losses, liabilities, damages, demands or expenses arising
out of the gross negligence or wilful misconduct of the other party or any of its affiliates, agents, directors, officers, employees
or assigns. Limitation of Liability. IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES
RESULTING FROM THE LICENSE GRANTED PURSUANT TO THIS AGREEMENT OR THE USE OR COMMERCIAL DEVELOPMENT OF PRODUCT.


 


{***} 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.


 




    	 	Page 6 of 28	 



     


    

 


		B.	WARRANTIES



Subject as herein provided
HEMISPHERX warrants to SCIEN that:


 


		·	All
                                         Product(s) supplied hereunder will comply with the Dossier and with any specification
                                         agreed for them in the Quality Agreement;



		·	It
                                         is not aware of any rights of any third party in the Territory which would or might render
                                         the sale of the Product, or the use of any of the Trademarks on or in relation to the
                                         Products, unlawful;



		·	It
                                         is the owner or the permitted licensee of all Intellectual Property Rights and it is
                                         not aware of any claims of any third party in the Territory or worldwide related to the
                                         fact that the Products infringes any intellectual property of such third party.



		·	Nothing
                                         in this Agreement shall exclude either party’s liability for death or personal
                                         injury.



 


Subject to the above WARRANTIES, HEMISPHERX shall
indemnify and hold harmless SCIEN and its respective employees from any loss, damage or claim made by a third party in respect
of (i) the death or personal injury arising from the manufacture or use of the Products in the Territory or (ii) infringement
of third party intellectual property, if and to the extent such loss, damage or claim is caused by any act or omission of HEMISPHERX
and is not attributable directly or indirectly to the breach of any of the material terms of this Agreement by SCIEN or by any
wilful default or negligent act or omission of SCIEN, its employees or its agents.


 


		1.	The indemnity given by HEMISPHERX shall be subject to the
following conditions:



 


		·	No
                                         indemnity shall be claimed unless notice is given by SCIEN claiming the indemnity to
                                         HEMISPHERX together with details of the claim promptly on notice of such claim being
                                         received by the SCIEN;



		·	No
                                         admissions of liability or compromise or offer of settlement of any claim shall be made
                                         by SCIEN without the prior written consent of HEMISPHERX; and



		·	HEMISPHERX
                                         shall have full control over any claim, proceedings or settlement negotiations in respect
                                         of which it is providing the indemnity.



 


Subject to clause X.B 1.), SCIEN shall defend and
indemnify HEMISPHERX and its Affiliates and hold each of them harmless against all claims, demands, actions, losses, expenses,
damages, liabilities, costs (including interest, penalties and reasonable attorneys' fees) and judgements suffered by each of
them, which arise out of SCIEN’s negligent or wilful acts or omissions or which otherwise arise out of SCIEN’s breach
of the Agreement.


 


Survivability. The obligations set forth in this
Section X. shall survive the termination of this Agreement for the legal periods of limitation provided by US law.


 


{***}
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.


 




    	 	Page 7 of 28	 



     


    

 


		XI.	CONFIDENTIALITY



 


		A.	SCIEN and HEMISPHERX agree to keep secret and confidential
                                         all confidential, proprietary or non-public information ("Confidential Information")
                                         of the other Party .This provision shall survive termination or expiration of this Agreement.



 


		B.	Such Confidential Information will be kept confidential until
                                         5 years after the expiration of termination of this Agreement. Notwithstanding the foregoing
                                         , Confidential Information of a Party shall not include information which the other Party
                                         can establish by written documentation was (a) to have been publicly known prior to disclosure
                                         of such information by the disclosing Party to the other Party, (b) to have become publicly
                                         known, without fault on the part of the other Party, subsequent to disclosure of such
                                         information by the disclosing Party to the other Party, (c) to have been received by
                                         the other Party at any time from a source , other than the disclosing Party, rightfully
                                         having possession of and the right to disclose such information, (d) to have been otherwise
                                         known by the other Party prior to disclosure of such information by the disclosing Party
                                         to the other Party, or (e) to have been independently developed by employees or agents
                                         of the other Party without access to or use of such information disclosed by the disclosing
                                         Party to the other Party.



 


		C.	The confidentiality obligations contained in this section
                                         XI shall not apply to the extent that the receiving Party (the "Recipient")
                                         is required (a) to disclose information by law, order or regulation of a governmental
                                         agency or a court of competent jurisdiction , or (b) to disclose information to any governmental
                                         agency for purposes of obtaining approval to test or market a Product , provided in either
                                         case that the Recipient shall provide written notice thereof to the other Party and sufficient
                                         opportunity to object to any such disclosure or to request confidential treatment thereof.



 


		XII.	PROSECUTION, INFRINGEMENT, AND DEFENSE OF HEMISPHERX
INTELLECTUAL PROPERTY



 


		A.	HEMISPHERX will be responsible for and shall control, at
its expense, the preparation, filing, prosecution and maintenance of HEMISPHERX Intellectual Property.



 


		B.	SCIEN will cooperate in all reasonable ways to establish
and protect HEMISPHERX Intellectual Property in the Territory.



 


		C.	HEMISPHERX, at its expense, will have the right to determine
the appropriate course of action to enforce its HEMISPHERX Intellectual Property against infringement or otherwise abate the infringement
thereof , to take (or refrain from taking) appropriate action to enforce its HEMISPHERX Intellectual Property, to control any
litigation or other enforcement action and to enter into, or permit, the settlement of any such litigation or other enforcement
action with respect to its Intellectual Property .



 


		D.	Each Party shall promptly notify the other Party in writing
if any claim, action, demand or other proceeding (a "Claim") is brought against or is threatened to be brought against
such Party alleging that the sale of Product violates another party's intellectual property.



 


		E.	SCIEN will promptly notify HEMISPHERX of any Third party
SCIEN knows or believes may be infringing HEMISPHERX Intellectual Property and will, to the greatest extent reasonably possible,
provide to HEMISPHERX any information SCIEN has in support of such belief. HEMISPHERX will have the right, but not the obligation,
to use such information in an infringement action against such third Party. SCIEN agrees to cooperate with HEMISPHERX in any action
for infringement of HEMISPHERX, and HEMISPHERX will reimburse SCIEN for all reasonable costs incurred by it in providing cooperation
requested by HEMISPHERX.



 


		F.	HEMISPHERX is and shall remain the sole legal and registered
owner for any trademark or trade name of “Interferon alfa-n3 (human leukocyte derived)". The parties shall work together,
upon commercial approval in the Territory to secure a trade name in the Territory.



 


{***} 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.


 




    	 	Page 8 of 28	 



     


    

 


		G.	HEMISPHERX hereby grants to SCIEN and SCIEN hereby accepts
the right, privilege and exclusive license to use of “Interferon alfa-n3 (human leukocyte derived)” solely in connection
with the terms of the Sales, Marketing, Distribution and Supply Agreement of Product in the Territory for the Term of this Agreement.
Should the Agreement expire or terminate, the right to use the trademark shall also terminate. SCIEN shall use “Interferon
alfa-n3 (human leukocyte derived)” at all times for the sole purpose of marketing of Product for no other purpose.



 


		H.	The terms of the intellectual property license hereby granted
shall be effective upon the Effective Date of this Agreement and during the term of this Agreement, unless sooner terminated in
accordance with the provisions of the Sales, Marketing, Distribution and Supply Agreement between the parties.



 


1.          Good
Will. SCIEN recognizes that there exists great value and good will associated with the Intellectual Property of Interferon alfa-n3
(human leukocyte derived)”


 


2.
          SCIEN agrees that it will not during the term of this Agreement,
or thereafter, attack the title or any rights of HEMISPHERX in and to Interferon alfa-n3 (human leukocyte derived) or attack the
validity of the license granted herein by HEMISPHERX and solely owned by HEMISPHERX.


 


		I.	SCIEN agrees to assist HEMISPHERX to the extent necessary
                                         in the procurement of any protection or to protect any of HEMISPHERX's right to Interferon
                                         alfa-n3 (human leukocyte derived) and HEMISPHERX, if it so desires, may commence or prosecute
                                         any claims or suits in its own name or in the name of SCIEN or join SCIEN as a party
                                         thereto. SCIEN shall notify HEMISPHERX in writing of any infringements or imitations
                                         by others of “Interferon alfa-n3 (human leukocyte derived) which may come to SCIEN
                                         's attention, and HEMISPHERX shall have the sole right to determine whether or not any
                                         action shall be taken on account of any such infringements or imitations. SCIEN shall
                                         not institute any suit or take any action on account of any such infringements or imitation
                                         without first obtaining the written consent of the HEMISPHERX so to do.



 


		J.	SCIEN agrees to cooperate fully and in good faith with
HEMISPHERX for the purpose of securing and preserving HEMISPHERX's rights.



 


K.          It
is agreed that nothing contained in this Sales, Marketing, Distribution, and Supply Agreement shall be construed as an assignment
or grant to the SCIEN of any rights, title or interest in or to “Interferon alfa-n3 (human leukocyte derived)".


 


		L.	It is further understood that all rights relating thereto
                                         are reserved by HEMISPHERX, except for the license hereunder to SCIEN of the right to
                                         use and utilize the name Interferon alfa-n3 (human leukocyte derived) only as specifically
                                         and expressly provided in this Agreement.



 


		M.	In the event of termination of this license for any reason,
                                         SCIEN shall within 6months (as described in the Termination clause), cease all use of
                                         the “Interferon alfa-n3 (human leukocyte derived)”. SCIEN shall not thereafter
                                         use any names, mark or trade name similar thereto belonging to HEMISPHERX. Termination
                                         of the license under the provisions of this Agreement shall be without prejudice to any
                                         rights which HEMISPHERX may otherwise have against SCIEN.



 


		N.	SCIEN shall, and shall cause its shareholders, officers,
                                         directors, and managing personnel to, comply with all laws, rules and government regulations
                                         pertaining to its business and shall not violate any laws which would create an adverse
                                         effect on “Interferon alfa-n3 (human leukocyte derived)” in the U.S. and/or
                                         the Territory.



 


		O.	Relationship of Parties. SCIEN shall not in any manner
or respect be the legal representative or agent of HEMISPHERX and shall not enter into or create any contracts, Agreements, or
obligations on the part of HEMISPHERX, either expressed or implied, nor bind HEMISPHERX in any manner or respect whatsoever regarding
its intellectual property; it being understood that this Agreement is only a contract for the licensed use of the product names
in connection with the terms in 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.


 




    	 	Page 9 of 28	 



     


    

 


		XIII.	BUYOUT



 


HEMISPHERX will have the option at any time to buy out this
Agreement. If exercised within the first two (2) years HEMISPHERX will pay SCIEN three (3) times the Product sales for the preceding
12 months. If exercised after year 3, HEMISPHERX will pay SCIEN two (2) times the Product sales for the preceding 12 months.


 


XIV.         MISCELLANEOUS.


 


		A.	Notices. Notices sent pursuant to this Agreement are valid
if in writing and addressed to the parties at the respective addresses given below or at such other addresses as either party
shall notify the other in writing and sent by registered or certified mail, postage prepaid and return receipt requested, or by
Federal Express or other comparable courier providing proof of delivery, and shall be deemed duly given and received (i) if mailed,
on the third business day following the mailing thereof, or (ii) if sent by courier, the date of its receipt (or if not on a business
day, the next succeeding business day).



 


If to HEMISPHERX:


 


Thomas K. Equels, President and CEO


One Penn Center


1617 JFK Boulevard


Suite 500


Philadelphia, PA 19103 United States


 


If to SCIEN:


Abdelrhman Mofeed Zhreldin


Business Development Manager


Scientific Products Pharmaceutical Co. Ltd


Tahlia Street, P.O Box 10485,


Riyadh 11433 Saudi Arabia


 


		B.	This Agreement and the transactions contemplated herein
shall be governed by, and construed in accordance with, the laws of the State of Delaware, USA and disputes, if not resolved by
the Parties, will be settled by binding arbitration in and under the rules of arbitration in London, England.



 


		C.	This Agreement constitutes the entire understanding of
the parties with respect to the purchase and sale of Products and supersedes all prior discussions, agreements, and understandings
between HEMISPHERX and SCIEN.



 


		D.	Each party an independent contractor to the other and the
relationship between the parties shall not be construed to be that of an employer and employee, or to constitute a partnership,
joint venture, or agency of any kind.



 


		E.	This Agreement may only be amended in a writing signed
by both parties hereto.



 


		F.	If any provision of this Agreement is declared invalid
or unenforceable by a court having competent jurisdiction, it is mutually agreed that this Agreement shall endure except for the
part declared invalid or unenforceable by order of such court.



 


		G.	This Agreement may be executed in one or more counterparts,
each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.



 


{***} 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.


 




    	 	Page 10 of 28	 



     


    

 


		H.	Prior to their release, the parties must agree on press
releases or market communication that utilises the other Party’s name.



 


Counterparts; Integration; Effectiveness; Electronic Execution


 


This Agreement may be executed in counterparts (and by different
parties hereto in different counterparts), each of which shall constitute an original, but all of which when taken together shall
constitute a single contract. This Agreement constitutes the entire contract among the parties relating to the subject matter
hereof and supersede any and all previous agreements and understandings, oral or written, relating to the subject matter hereof.


 


This Agreement shall become effective when it shall have been
executed by all parties and upon receipt of all counterparts hereof that, when taken together, bear the signatures of each of
the other parties hereto. Delivery of an executed counterpart of a signature page of this Agreement by e-mail and/or telecopy
shall be effective as delivery of a manually executed counterpart of this Agreement.


 


The words "execution," "signed," "signature,"
and words of like shall be deemed to include electronic signatures or the keeping of records in electronic form, each of which
shall be of the same legal effect, validity or enforceability as a manually executed signature or the use of a paper-based recordkeeping
system, as the case may be, to the extent and as provided for in any applicable law, including the Federal Electronic Signatures
in Global and National Commerce Act, and any other similar State laws based on the Uniform Electronic Transactions Act.


 


IN WITNESS WHEREOF, the parties have executed this Agreement
as of the last date below and in so doing acknowledge that they have a corporate authority to bind their respective organizations
to this Agreement.


 


	SCIENTIFIC PRODUCTS PHARMACEUTICAL
    CO. LTD:	 	HEMISPHERX BIOPHARMA, INC:
	 	 	 
	S/	 	S/
	Saleh Al-Abdullah Al-Rasheed	 	Thomas K. Equels
	CEO & Owner	 	President and CEO
	 	 	 
	Date:	 	Date:
	 	 	 
	 	 	 


 


{***} 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.


 




    	 	Page 11 of 28	 



     


    

 


 


 


Exhibit 1


 


The drug, Interferon Alfa-n3, is intended for investigational
use in the countries in which it is distributed prior to receipt of RAA;


 


The drug, Interferon Alfa-n3, meets your specifications as
reflected on the attached Certificate of Analysis;


 


The drug, Interferon Alfa-n3, is not in conflict with the laws
of the countries in which it is distributed;


 


The investigation will be conducted in accordance with good
clinical practices, including review and approval of the study by an independent ethics panel and informed consent of the study
subjects;


 


The drug, Interferon Alfa-n3, does not present an imminent
hazard to public health, either in the United States, if the drug were to be reimported, or in the countries in which it is distributed;


 


The drug, Interferon Alfa-n3, is labelled in accordance with
the laws of the countries in which it is distributed.


 


I have reviewed the attached labels and the current Certificate
of Analysis against the specifications and agree with the above statements that these meet the laws of the countries in which
the product will be distributed.


 


	Signature: 	 	Date: 	 	 


 


Printed Name: Saleh Al- Rashid


 


Title: Chairman and CEO


 


Company: Scientific Products Pharmaceutical Co. LTD


 


{***} 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.


 




    	 	Page 12 of 28	 



     


    

 


Certificate of Analysis


 


{***}


 


{***} 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.


 




    	 	Page 13 of 28	 



     


    

 


Label information enlarged for ease of read.


 


{***}


 


Enlarged Label:


 


{***}


 


Caution: Limited by Federal (US)


 


Law to Investigational Use.


 


Manufactured For:


 


Hemispherx Biopharma, Inc.


 


Philadelphia, PA 19103


 


(U.S.A.)


 


Actual Label:


 


{***}


 


{***} 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.


 




    	 	Page 14 of 28	 



     


    

 


Exhibit 2 Study Protocol Synopsis


 


A Compassionate Use Protocol Using Natural
Leukocyte Interferon (Alfa-n3) for Individual Treatment of Symptomatic Patients with Middle East Respiratory Syndrome (MERS)


 


{***}


 


{***} 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.


 




    	 	Page 15 of 28	 



     


    

 


Exhibit 3 Business Plan


 


{***} 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.


 




    	 	Page 16 of 28	 



     


    

 


Exhibit 4


 


TECHNICAL / QUALITY AGREEMENT 


 


1.          Parties


 


This Quality Agreement is entered by and between Scientific
Products Pharmaceutical Co. LTD., a pharmaceutical company with its primary offices located at Tahlia Street, P.O Box 10485, Riyadh
11433 Saudi Arabia (“SCIEN”) and Hemispherx Biopharma, Inc. 783 Jersey Avenue, New Brunswick, New Jersey 08901(HEMISPHERX).


 


2.          Purpose


 


The purpose of this Quality Agreement is to clearly define
the quality operating procedures, duties and responsibilities to be employed by SCIEN and HEMISPHERX in the conduct of
activities by SCIEN for Hemispherx Biopharma, Inc. The objective of these procedures and this Quality Agreement is assurance
that services are conducted in a timely, consistent and uniform manner and in accordance with current laws, directives, regulations
and guidelines, as may be applicable to the specific project(s). These requirements may include those defined by the U.S. FDA’s
regulations At 21CFR314.80 (Post-marketing reporting of adverse drug experiences for drugs), 21CFR312.32 (IND safety reporting)
21CFR600.80 (Post marketing reporting of adverse experiences for biologics) 21CFR Parts 210 and 211 (“current Good Manufacturing
Practices” or “cGMPs”) with particular interest in 21CFR211.1.42 (Warehousing), 21CFR211.150 (Distribution),
21CFR211.204 (Returned drug) and 21CFR211.208 (Drug product salvaging), ICH Guidance for Industry: E6 Good Clinical Practice Consolidated
Guidance and/or others that may be appropriate for the particular project.


 


3.          Scope


 


This Quality Agreement is to be applied to the activities performed
by SCIEN, for HEMISPHERX as specifically defined by the Sales, Marketing, Distribution, and Supply Agreement January ___, 2016
(“Agreement”) to which this Quality Agreement is an integral Exhibit. In the event of a conflict between the terms
of the Agreement and this Quality Agreement, the terms of the Agreement shall control. Unless
otherwise stated in these documents, SCIEN shall follow its Standard Operating Procedures (“SOPs”) with respect to
the activities it shall carry out in accordance with the Agreement. Copies of all relevant SOPs shall be provided to HEMISPHERX
for review during audits.


 


4.          Confidentiality


 


The information and procedures contained in this Quality Agreement
are confidential and subject to the terms and conditions of the confidentiality provisions as set forth in the Confidential Disclosure
Agreement September 22, 2014 (“CDA”) executed by HEMISPHERX and SCIEN.


 


5.          Terms



 


This Agreement between HEMISPHERX and SCIEN shall be in effect
beginning the last date of execution set forth on the signature page to the Agreement (the “Effective Date”) to which
this Quality Agreement is Exhibit 2 and remain in effect until HEMISPHERX and SCIEN terminate the Agreement or it is superseded
by a revised Quality Agreement executed by both parties. This Quality Agreement should be reviewed periodically by both
parties for any needed updating, revisions, amendments, and the like. Regular periodic review of this Quality Agreement should
be conducted to ensure it is up-to-date.


 


{***} 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.


 




    	 	Page 17 of 28	 



     


    

 


HEMISPHERX may perform audits for initial qualification of
SCIEN as well as periodic audits and “for cause” audits. At mutually agreed upon times, HEMISPHERX may review
standard operating and other quality control procedures and records and the records of SCIEN relating to the Agreement.
Such routine and general oversight review is to be requested at least twenty (20) business days in advance, limited to two (2)
persons, completed within one (1) to two (2) business days and shall be offered to HEMISPHERX one (1) time each calendar year.
SCIEN will make every reasonable effort to accommodate the special circumstances that may arise pursuant to “for
cause” audits. The following applies to all audits:


 


		·	Prior to an audit
                                         HEMISPHERX will communicate to SCIEN the scope of the audit.



		·	HEMISPHERX will
                                         prepare a written report of the results of the audit and forward a copy to SCIEN.



 


SCIEN will provide a written response to HEMISPHERX’s
written audit report within twenty (20) business days of receipt of such report setting forth the corrective actions to be taken
by SCIEN, if any, and a timeline for such implementation.


 


In the event of an inspection by any governmental
or regulatory authority concerning the activities carried out under the Agreement, SCIEN shall notify HEMISPHERX promptly
upon learning of such an inspection, shall supply HEMISPHERX with copies of any correspondence or portions of correspondence relating
to HEMISPHERX’s materials and shall inform HEMISPHERX of the general findings and outcomes of such inspections.


 


SCIEN and HEMISPHERX shall cooperate with each other during
any such inspection, investigation or other inquiry, including applying reasonable effort, as might be practical, at allowing,
upon reasonable request, a representative of HEMISPHERX to be on site during such inspection, investigation or other inquiry,
and providing copies of all documents related to the inspection. Each party acknowledges that it may not direct the manner in
which the other party fulfills its obligations to permit inspection by governmental entities


 


6.          Dispute
Resolution


 


If a dispute arises between the parties under this Agreement,
the parties agree that, prior to either pursuing other available remedies, decision-making individuals from each party will promptly
meet, either in person or by telephone, to attempt in good faith to negotiate a resolution of the dispute. If, within sixty days
after such meeting, the parties are unable to resolve the dispute (or such longer time as the parties may agree) either party
is free to pursue its legal remedies.


 


7.          Definitions


 


Adverse experience: Any adverse event associated
with the use of a biological or drug product in humans, whether or not considered product related, including the following: an
adverse event occurring in the course of the use of a biological or drug product in professional practice; an adverse event occurring
from overdose of the product whether accidental or intentional; an adverse event occurring from abuse of the product; an adverse
event occurring from withdrawal of the product; and any failure of expected pharmacological action.


 


Disability: A substantial disruption of a person’s
ability to conduct normal life functions.


 


Life-threatening adverse experience: Any adverse
experience that places the patient, in the view of the initial reporter, at immediate risk of death from the adverse experience
as it occurred, i.e., it does not include an adverse experience that, had it occurred in a more severe form, might have caused
death.


 


Labeled event: An adverse experience that is listed
on the product insert as having been observed in patients who are receiving the drug product.


 


{***} 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.


 




    	 	Page 18 of 28	 



     


    

 


Drug Product: A finished dosage form, for example, tablet,
capsule, or solution that contains an active ingredient generally, but not necessarily, in association with inactive ingredients


 


Serious adverse experience: Any adverse experience
occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse experience, inpatient hospitalization
or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth
defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered
a serious adverse experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may
require medical or surgical intervention to prevent one of the outcomes listed in this definition.


 


Unexpected adverse experience: Any adverse experience
that is not listed in the current labelling for the biological or drug product. This includes events that may be symptomatically
and pathophysiologically related to an event listed in the labelling, but differ from the event because of greater severity or
specificity.


 


For example, under this definition, hepatic necrosis would
be unexpected (by virtue of greater severity) if the labeling only referred to elevated hepatic enzymes or hepatitis. Similarly,
cerebral thromboembolism and cerebral vasculitis would be unexpected (by virtue of greater specificity) if the labeling only listed
cerebral vascular accidents. “Unexpected,” as used in this definition, refers to an adverse experience that has not
been previously observed (i.e., included in the labeling) rather than from the perspective of such experience not being anticipated
from the pharmacological properties of the pharmaceutical product.


 


Call report: A list of all questions, requests for circulars,
and physician/patient complaints received by SCIEN's Clinical Support Department is prepared monthly by SCIEN staff
and is forwarded to HEMISPHERX RA/QA Department.


 


Audit: A systematic examination of processes, controls
and systems, operating procedures, reports, records and/or data to assess SCIEN’s compliance with standards, regulatory
submissions, SOPs; applicable laws, regulations, directives, standards and guidelines; the terms of this Agreement and other contracts
in place defining the services being provided and to verify data integrity.


 


Good Clinical Practices (“GCPs”): Good clinical
practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting
trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights,
safety, and wellbeing of trial subjects are protected, consistent with the principles that have their origin in the Declaration
of Helsinki, and that the clinical trial data are credible. ICH Guidance for Industry: E6 Good Clinical Practice Consolidated
Guidance.


 


Good Manufacturing Practices (“GMPs”): The
recognized pharmaceutical regulations and requirements of regulatory authorities such as those defined by the U.S. FDA’s
regulations at 21CFR Parts 210 and 211.


 


Key Contacts:  Persons at SCIEN and HEMISPHERX
assigned to assure proper communication and follow-up in a timely manner within both parties’ organizations. Names, titles
and full contact information for Key Contacts shall be appended to this Agreement as Attachment 1 and should be maintained up-to-date
during the course of the project.


 


Observation: A statement of fact made during an audit
that is substantiated by objective evidence. HEMISPHERX categorizes observations as follows:


 


		o	Critical: May pose risk to patient or consumer or otherwise
                                         compromise the integrity or quality of the material, product, process, or service being
                                         provided. Other instances that could be defined as a critical observation include: A
                                         practice that poses an immediate safety risk to personnel; Quality System(s) missing
                                         or not in compliance with regulations, guidelines, or corporate policies.



		o	Major:  Does not fully comply with regulations, guidelines
                                         or corporate policies and may pose unnecessary risks to the integrity or quality of material,
                                         product, process or service being provided. Other instances that could be defined as
                                         a major observation include: Likely or probable safety risk to personnel; Quality System(s)
                                         weak or needing improvement; repeated Minor deficiencies of a similar nature that indicate
                                         a systemic problem and therefore may be classified as Major.



 


{***} 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.


 




    	 	Page 19 of 28	 



     


    

 


		o	Minor:  Does not comply with regulations, guidelines,
                                         or corporate policies but does not directly impact the integrity or quality of the material,
                                         product, process, or service being provided.



		o	Comment:  Compliant with regulations, guidelines and/or
                                         corporate policies; however, the auditor comment serves as a recommendation relative
                                         to maintaining or improving a specific condition noted.



 


Out-of-Specification / Out-of-Trend (“OOS / “OOT”):
 A result that is not within the established specifications or trend, whether these are qualitative or quantitative.


 


Standard Operating Procedures (“SOPs”):
Procedures in effect at SCIEN that define the processes and controls by and under which activities are to be conducted
to assure compliance with the appropriate Code of Federal Regulations.


 


7.          Communications


 


To assure proper communication, notification
and follow-up in a timely manner by both parties, “Key” contacts are listed in Attachment 1 of this Agreement. Key
contacts shall have access to project managers and technical staff and, upon reasonable notice and as required, facilitate resolution
of any issues. Every effort will be made by SCIEN to accommodate timely communications, including face-to-face meetings,
with HEMISPHERX.


 


8.          Change
of Control 


 


SCIEN will maintain and follow change control SOP(s)
to ensure that changes to equipment, procedures, processes, etc. occur in a controlled manner and in compliance with requirements
e defined by the U.S. FDA’s regulations (see Section 2). The implementation of any change that may directly impact the integrity
of the activities conducted or data being supplied for HEMISPHERX will require prior written approval of HEMISPHERX. SCIEN
and HEMISPHERX will advise the appropriate organization’s staff member (See Attachment 1) before implementation of a
change, by either party, to equipment, procedures, specifications, processes, clinical protocols, product claims or facilities
directly related to HEMISPHERX’s specific products and processes. Each party agrees to review the proposed change in a timely
manner and, at its discretion, may audit and/or request an alternative or additional change prior to the implementation of the
proposed change. The respective party will review the proposed change, determine if it is reasonably practicable to implement
the change and can suggest alternative or additional changes prior to the implementation of the proposed change. Change control
requirements should be articulated within the specific operation’s documentation practices.


 


HEMISPHERX is responsible for assuring changes are in accordance
with and/or reported to the investigational, marketing and/or any other filing with regulatory agencies (IND, IMPD, CTA, NDA,
MA, etc.) and for informing SCIEN of any changes requested by regulatory agencies. SCIEN agrees to keep HEMISPHERX
fully informed of any and all communications with regulatory agencies that may affect the services being provided to HEMISPHERX
by SCIEN.


 


This Agreement is not meant to supersede or replace controlled
documents typically used to define and record the work to be conducted by SCIEN for HEMISPHERX. Specific requirements of this
Agreement and/or any service contracts shall be articulated within SCIEN’s current operating procedures and documentation
systems.


 


9.          Responsibilities


 


SCIEN is responsible for:


		1)	case management support services
                                         to patients and maintain a 24-hour/365-day a year telephone service for assistance of
                                         prescription drug-related medical emergencies to patients



		2)	the distribution of product, including
                                         the shipping, handling and storage and all rules and regulations of every governmental
                                         authority having jurisdiction over the shipping, handling, storage, distribution, and
                                         dispensing of Product



 


{***} 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.


 




    	 	Page 20 of 28	 



     


    

 


		3)	confirming the product labelling
                                         requirements in the territory



		4)	conforming to all labeled specifications
                                         concerning the shipping, handling and storage of Product



		5)	notifying HEMISPHERX of any unacceptable
                                         storage or handling deviation within one (1) business day



		6)	inspecting all product shipments
                                         received by SCIEN from HEMISPHERX and reporting any damage, defect, loss in transit,
                                         or other shipping errors to HEMISPHERX within one (1) business days of receipt by SCIEN



		7)	administering recalls, field alerts,
                                         warning letters, quarantines or withdrawals in accordance with HEMISPHERX instructions
                                         (See Attachment 2)



		8)	administering HEMISPHERX’s
                                         Returned Goods Policy (See Attachment 3)



		9)	immediately (within 24 hours of
                                         becoming aware of event) notifying HEMISPHERX of any serious and unexpected side effects
                                         (Adverse Experiences reported to SCIEN, as defined by 21CFR 314.80 and 21CFR 312.32))



		10)	providing HEMISPHERX with written
                                         Adverse Experience Reports (at the latest day 4 after becoming aware of event)



		11)	notifying the Regulatory Authorities
                                         within the Territory of any reportable adverse experiences



		12)	notifying the Regulatory Authorities
                                         within the Territory of any suspected counterfeiting or tampering except as required
                                         different by law



		13)	obtaining program approval from
                                         appropriate regulatory agencies in the Territory



		14)	keeping HEMISPHERX fully informed
                                         of any and all communications with regulatory agencies that may affect the services being
                                         provided to HEMISPHERX by SCIEN



		15)	receiving and processing complaints



		16)	notifying HEMISPHERX of complaints
                                         and actions taken or to be taken to address the complaints



		17)	the performance of all services
                                         provided by SCIEN’s subcontractors



		18)	communicating to HEMISPHERX any
                                         events of non-conformance that impact the quality of HEMISPHERX’s product. Examples
                                         of non-conformances may include, but are not limited to: equipment failure, shipping
                                         error or documentation error, labeling error, improper storage, facilities system error,
                                         and unplanned study protocol deviations. When a non-conformance event occurs that is
                                         specific to HEMISPHERX’s product, SCIEN will conduct an investigation and provide
                                         copies of all investigation documentation to HEMISPHERX for review and input



		19)	for initiating, monitoring and
                                         completing CAPA tasks related to discrepancies, errors and incidents involving services
                                         that are under SCIEN’s control



 


HEMISPHERX is responsible for:


		1)	release of product following review
                                         of all manufacturing and quality control testing requirements to confirm the batch has
                                         been manufactured according to approved processes and specifications



		2)	supply all necessary quality documentation
                                         with shipments to allow product importation and release



		3)	ensuring product intended for
                                         supply in territory is labelled accordingly



		4)	assuring changes to the established
                                         operations are in accordance with and/or reported to the investigational, marketing and/or
                                         any other filing with regulatory agencies (IND, IMPD, CTA, NDA, MA, etc.).



		5)	informing SCIEN of any changes
                                         requested by regulatory agencies



		6)	assist with/address any Agencies
                                         requests relating to manufacture of product



		7)	providing SCIEN any information
                                         that could result in a field alert or recall of a product under a HEMISPHERX NDA or ANDA
                                         immediately, but no more than one (1) business day after discovery. HEMISPHERX interprets
                                         FDA 21 CFR 314.81, “Other Post-Marketing Reports,” to require a Field Alert
                                         Report to be made within three (3) days of an occurrence of an OOS result, whether that
                                         result is confirmed or not. The only exception to this would be where the original result
                                         was invalidated within the three (3) days. In that case, no field alert would be required



		8)	making the proper reports to the
                                         FDA regarding a field alert or recall



 


{***} 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.


 




    	 	Page 21 of 28	 



     


    

 


		9)	making the proper reports to the
                                         FDA regarding any serious and unexpected side effects



		10)	communicating to SCIEN any events
                                         of non-conformance that impact the quality of HEMISPHERX’s product. Examples of
                                         non-conformances may include, but are not limited to: contamination, calculation or documentation
                                         error, labeling error. When a non-conformance event occurs HEMISPHERX will conduct an
                                         investigation and inform SCIEN of any appropriate action to be taken



		11)	for initiating, monitoring and
                                         completing CAPA tasks related to discrepancies, errors and incidents involving services
                                         that are under HEMISPHERX’s control



		12)	contribute to customer complaint
                                         investigations where possible issues due to manufacturing process may have contributed
                                         to complaint



 


HEMISPHERX and SCIEN are separately responsible for securing
and maintaining all required licenses, permits and certificates applicable to their respective operations and each shall comply
with any and all applicable federal, state and local laws, including but not limited to (i) the Federal Food Drug and Cosmetic
Act; (ii) the Social Security Act; (iii) HIPAA; (iv) all federal and state health care anti-fraud and abuse laws, and (v) all
state privacy, and consumer protection laws, including those relating to the use of medical and prescription information for commercial
purposes.


 


10.         Subcontractors


 


SCIEN may enter into agreements between SCIEN
and a subcontractor. SCIEN will identify the services performed by each such subcontractor. SCIEN is responsible
for the performance of all services provided on behalf HEMISPHERX and the compliance of each subcontractor to the terms of this
Agreement. HEMISPHERX will be permitted to conduct periodic audits of the subcontractors to assure compliance to applicable GMP’s,
GLP’s and federal regulations (CFR’s).


 


11.         Standard
Operating Procedures (SOP’s)


 


The following HEMISPHERX SOP’s are relevant to this Quality
Agreement and interactions between HEMISPHERX and SCIEN and affiliates.


		A.	CLN-009 Handling Adverse Event Reports and Records



		B.	RA-001 Post Marketing Adverse Experience Reporting



		C.	QC-006 Investigation of Out of Specification Results



 


12.         Laboratory
Controls-N/A


 


13.         Documentation
and Record Maintenance


 


SCIEN shall preserve all records in accordance with any applicable
federal, state or local requirements. Raw data, documentation, batch records, source documents, product disposition records and
reports (collectively, “Documentation”) shall be retained by SCIEN for a minimum period of two (2) years after termination
or expiration of the Specialty Distributor Purchase and Service Agreement between HEMISPHERX and SCIEN. SCIEN shall, upon written
receipt of a written request from HEMISPHERX, finish such Documentation in a format reasonably acceptable to HEMISPHERX with thirty
(30) days of receipt of such request. In this case, the Documentation will be shipped to the Quality Assurance Manager named in
this Agreement (see Key Contact List, Attachment 1). It is the responsibility of HEMISPHERX to notify SCIEN of any changes in
this contact. During the retention period, documentation shall be available for inspection by HEMISPHERX, its authorized agents
and authorized government agencies.


 


14.         Complaints


 


In the event SCIEN is notified of a complaint, SCIEN will receive,
investigate and respond to the complaint following its internal procedures. A copy of all complaint investigation documentation
will be provided to HEMISPHERX.


 


{***} 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.


 




    	 	Page 22 of 28	 



     


    

 


15.         Contact
List of Key Personnel. See Attachment 1


 


IN WITNESS WHEREOF, the parties hereto have executed this Quality
Agreement as of the Effective Date.


 


Hemispherx Biopharma Inc.         


 


	Quality Assurance Signature: 	 	 


 


Printed Name: Victoria Scott


 


Title: Associate Director Quality and Regulatory


 


	Date: 	 	 


 


	Management Signature: 	 	 


 


Printed Name: Wayne Springate


 


Title: Senior Vice President Operations


 


	Date: 	 	 


 


SCIEN.


 


	Quality Assurance Signature: 	 	 


 


	Printed Name: 	 	 


 


	Title: 	 	 


 


	Date: 	 	 


 


	Management Signature: 	 	 


 


Printed Name: Abdelrhman Mofeed Zhreldin


 


Title: Business Development Manager


 


	Date: 	 	 


 


{***} 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.


 




    	 	Page 23 of 28	 



     


    

 


 


 


Attachment 1


List of Key Contacts


 


	SUBJECT	 	HEMISPHERX
    CONTACT	 	SCIEN
    CONTACT
	Regulatory Compliance Requirements

         

        Notification of Regulatory Agencies and Regulatory
        Submissions
	 	Victoria Scott

        Associate Director/Quality and Regulatory

        Phone: 732-249-3250

        Fax:732-249-6895

        Email:Regulatory@Hemispherx.net
	 	 
	Recall of Marketed Product	 	Victoria Scott

        Associate Director/Quality and Regulatory

        Phone: 732-249-3250

        Fax:732-249-6895

        Email:Regulatory@Hemispherx.net
	 	 
	Adverse Drug Events	 	David Strayer, MD

        Medical Director

        Phone:215-988-0880

        Fax: 215-988-1739

        Email: SAE@Hemispherx.net
	 	 
	Product Complaint	 	Victoria Scott

        Associate Director/Quality and Regulatory

        Phone: 732-249-3250

        Fax:732-249-6895

        Email:Victoria.Scott@Hemispherx.net
	 	 
	Field Alert Reports/Biological Product Deviation
    Reports	 	Victoria Scott

        Associate Director/Quality and Regulatory

        Phone: 732-249-3250

        Fax:732-249-6895

        Email:Victoria.Scott@Hemispherx.net
	 	 
	Change Control	 	Victoria Scott

        Associate Director/Quality and Regulatory

        Phone: 732-249-3250

        Fax:732-249-6895

        Email:Victoria.Scott@Hemispherx.net
	 	 
	Clinical Study Protocol Changes	 	David Strayer, MD

        Medical Director

        Phone:215-988-0880

        Fax: 215-988-1739

        Email: David.Strayer@Hemispherx.net
	 	 
	New or Revised Product Claims	 	David Strayer, MD

        Medical Director

        Phone:215-988-0880

        Fax: 215-988-1739

        Email: David.Strayer@Hemispherx.net
	 	 
	Documentation

        Quality Records

        Record Retention
	 	Victoria Scott

        Associate Director/Quality and Regulatory

        Phone: 732-249-3250

        Fax:732-249-6895

        Email:Victoria.Scott@Hemispherx.net
	 	 


 


{***} 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.


 




    	 	Page 24 of 28	 



     


    

 


	SUBJECT	 	HEMISPHERX
    CONTACT	 	 
	Product Testing and Release	 	Victoria Scott

        Associate Director/Quality and Regulatory

        Phone: 732-249-3250

        Fax:732-249-6895

        Email:Victoria.Scott@Hemispherx.net
	 	 
	Control of Components, Labelling and Packaging Materials

         
	 	Chris Cavalli

        VP Quality and Process Development

        Phone: 732-249-3250

        Email:Chris.Cavalli@Hemispherx.net

        Fax:732-249-6895
	 	 
	Product Storage and Shipping	 	Victoria Scott

        Associate Director/Quality and Regulatory

        Phone: 732-249-3250

        Fax:732-249-6895

        Email:Victoria.Scott@Hemispherx.net
	 	 
	Returned Goods	 	Victoria Scott

        Associate Director/Quality and Regulatory

        Phone: 732-249-3250

        Fax:732-249-6895

        Email:Victoria.Scott@Hemispherx.
	 	 
	Deviations/Investigations

         

        Nonconforming or Rejected Material
	 	Victoria Scott

        Associate Director/Quality and Regulatory

        Phone: 732-249-3250

        Fax:732-249-6895

        Email:Victoria.Scott@Hemispherx.net
	 	 
	Supplier Qualification	 	Victoria Scott

        Associate Director/Quality and Regulatory

        Phone: 732-249-3250

        Fax:732-249-6895

        Email:Victoria.Scott@Hemispherx.net
	 	 
	Quality Audits & Regulatory Inspections	 	Victoria Scott

        Associate Director/Quality and Regulatory

        Phone: 732-249-3250

        Fax:732-249-6895

        Email:Victoria.Scott@Hemispherx.net
	 	 


 


{***} 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.


 




    	 	Page 25 of 28	 



     


    

 


Attachment 2


QA-007-Product Recall


 


{***} 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.


 




    	 	Page 26 of 28	 



     


    

 


Attachment 3


HEMISPHERX Return Goods Policy


 


This Return Goods Policy us for all HEMISPHERX product, Interferon
alfa-n3 (human leukocyte derived) distributed by SCIEN.


 


The following products are eligible for return and reimbursement:


 


		·	Outdated
                                         Product: Product within two (2) months prior or six (6) months past expiration date and
                                         noted on product;



 


AND


 


		·	Product
                                         in its original container and bearing its original label.



 


OR


 


		·	Product
                                         which HEMISPHERX has specified be returned



 


The following products are not eligible for return and reimbursement:


 


		·	Product
                                         that is not outdated.



 


		·	Product
                                         in which the lot number and/or expiration date is missing, illegible, covered, and/or
                                         unreadable on original container.



 


		·	Product
                                         that has been damaged due to improper storage handling, fire, flood, or catastrophe.



 


		·	Product
                                         that has been sold expressly on a non-returnable basis.



 


		·	Product
                                         that is not in its original container and/or not bearing its original label.



 


		·	Product
                                         that is in its original container with a prescription label attached.



 


		·	Product
                                         that has been repackaged



 


		·	Partial
                                         Vials



 


		·	Product
                                         obtained illegally or via diverted means



 


		·	Product
                                         purchased on the “secondary source” market or from a distributor other than
                                         SCIEN.



 


		·	Product
                                         that HEMISPHERX determines, in its sole discretion, is otherwise adulterated, misbranded,
                                         or counterfeit.



 


HEMISPHERX will only accept returns shipped to SCIEN.
All eligible products shall be shipped in a safe, secure, and reliable manner, and in compliance with all applicable federal,
state and local laws, regulations and statutes. It is the shipper’s responsibility to securely package all return goods
to prevent to prevent breakage during transit and otherwise comply with the laws and regulations applicable to the packaging,
shipping, and transport of return goods shipments.


 


HEMISPHERX is not responsible for shipments lost and/or damaged
in transit. HEMISPHERX recommends that all customers insure return goods shipments.


 


HEMISPHERX will audit the quantities of return goods and final
reimbursement will be based on HEMISPHERX count. All products will be reimbursed based on the price paid direct purchasing customers
reimbursement will be issued in the form of credit or product replacement to the appropriate 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.


 




    	 	Page 27 of 28	 



     


    

 







To assist in accurate credit memo processing, please include
the following information:


 


1.          Purchasers
Name and Mailing Address


 


2.          Date
and Quantity


 


Return goods shipments which are deemed to be outside of this
policy will not be returned to the customer or the third party processor and no reimbursement will be issued by HEMISPHERX. HEMISPHERX
return goods policy is subject to change at any time and without prior notices to other parties.


 


{***} 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.


 



    	 	Page 28 of 28