HEMISPHERX BIOPHARMA INC (Form: 10-Q/A, Received: 08/29/2016 15:16:21)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q/A

(Amendment No. 1)

Quarterly Report Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

For the Quarterly Period Ended March 31, 2016

Commission File Number: 1-13441

HEMISPHERX BIOPHARMA, INC.

(Exact name of registrant as specified in its charter)

Delaware		52-0845822
(State or other jurisdiction of		(I.R.S. Employer
incorporation or organization)		Identification No.)

1617 JFK Boulevard, Suite 500, Philadelphia, PA 19103

(Address of principal executive offices) (Zip Code)

(215) 988-0080

(Registrant's telephone number, including area code)

(Former name, former address and former fiscal year, if changed since last report)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

x Yes ¨ No

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was required to submit and post such files).

x Yes ¨ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definition of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

¨	Large accelerated filer	¨	Accelerated filer
¨	Non-accelerated filer	x	Smaller reporting company

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ¨ Yes x No

247,918,529 shares of common stock were outstanding as of May 6, 2016.

EXPLANATORY NOTE

This Amendment No. 1 on Form 10-Q/A ("Amendment No. 1") amends our Quarterly Report on Form 10-Q for the quarter ended March 31, 2016 that was filed with the Securities and Exchange Commission, or SEC, on May 16, 2016 (the "Original Filing"). We are filing this Amendment No. 1 solely for the purpose of attaching as Exhibits 10.1 and 10.2 amended redacted copies of the Sales, Marketing, Distribution and Supply Agreement dated March 3, 2016 with Scientific Products Pharmaceutical Co. LTD and the Licensing agreement dated April 13, 2016 with Lonza Sales AG.

As required by Rule 12b-15 under the Securities Exchange Act of 1934, as amended, Item 15 of Part IV of the Original Filing has been amended to contain currently dated certifications from our Chief Executive Officer and Chief Financial Officer. The currently dated certifications are attached hereto as Exhibits 31.1 and 31.2. Because no financial statements of Hemispherx Biopharma, Inc. are contained in this Amendment No. 1, we are not including certifications pursuant to 18 U.S.C. 1350.

No other changes, other than described above, are made to the Original Filing other than to update the cover page and Exhibit Index of the Original Filing. Unless expressly stated, this Amendment No. 1 does not reflect events occurring after the filing of the Original Filing, nor does it modify or update in any way the disclosures contained in the Original Filing. Accordingly, this Amendment No. 1 should be read in conjunction with our Original Filing and our other filings made with the SEC subsequent to the filing of the Original Filing.

- 2 -

Part II – OTHER INFORMATION

ITEM 6: Exhibits

(a)

Exhibits

10.1		Sales, Marketing, Distribution and Supply Agreement dated March 3, 2016 with Scientific Products Pharmaceutical Co. LTD (1)

10.2		Licensing Agreement dated April 13, 2016 with Lonza Sales AG. (1)

31.1		Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the Company's Chief Executive Officer.

31.2		Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the Company's Chief Financial Officer.

32.1		Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the Company's Chief Executive Officer.

32.2		Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the Company's Chief Financial Officer.

101		The following materials from Hemispherx’ Quarterly Report on Form 10-Q for the period ended March 31, 2016 formatted in eXtensible Business Reporting Language (“XBRL”): (i) Condensed Balance Sheets; (ii) Condensed Consolidated Statements of Comprehensive Loss; (iii) Changes in Stockholders' Equity; (iv) Condensed Consolidated Statements of Cash Flows; and (v) Notes to Condensed Consolidated Financial Statements.

(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.

- 3 -

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	HEMISPHERX BIOPHARMA, INC.

	/s/ Thomas K. Equels
	Thomas K. Equels, Esq.
	Chief Executive Officer & President

	/s/ Adam Pascale
	Adam Pascale
	Chief Financial Officer

Date: August 29, 2016

- 4 -

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 THE 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

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.

Page 2 of 28

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

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.

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.

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.

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.

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).

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.

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.

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

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

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.

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.

Page 4 of 28

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.

REPORTS AND PAYMENTS

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.

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.

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.

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

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

Termination for breach will include:

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

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.

Page 5 of 28

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.

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.

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.

INDEMNIFICATION AND WARRANTIES

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.

Page 6 of 28

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.

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.

Page 7 of 28

XI. CONFIDENTIALITY

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.

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.

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

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

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

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 .

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.

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.

Page 8 of 28

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.

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.

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.

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.

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)".

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.

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.

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.

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.

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.

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

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.

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.

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.

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

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.

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.

Page 10 of 28

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/ Saleh Al-Abdullah Al-Rasheed		S/ Thomas K. Equels
Saleh Al-Abdullah Al-Rasheed		Thomas K. Equels
CEO & Owner		President and CEO

Date:		Date:

3-29-2016		3-31-16

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

Page 12 of 28

Certificate of Analysis

{***}

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:

{***}

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)

{***}

Page 15 of 28

Exhibit 3 Business Plan

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.

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.

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:

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.

Page 19 of 28

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.

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.

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:

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

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

Page 20 of 28

confirming the product labelling requirements in the territory

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

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

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

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

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

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:

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

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

ensuring product intended for supply in territory is labelled accordingly

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.).

informing SCIEN of any changes requested by regulatory agencies

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

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

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

Page 21 of 28

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.

CLN-009 Handling Adverse Event Reports and Records

RA-001 Post Marketing Adverse Experience Reporting

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.

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: _________________________________________________________________________

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

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

Page 25 of 28

Attachment 2

QA-007-Product Recall

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.

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.

Page 27 of 28

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

Purchasers Name and Mailing Address

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.

Page 28 of 28

Exhibit 10.2

CONFIDENTIAL

LONZA

{***} LICENSE

LICENCE AGREEMENT

between

LONZA SALES AG

and

Hemispherx Biopharma, Inc

CONFIDENTIAL

LONZA

INDEX

ARTICLE	TITLE	PAGE

1.	Definitions and Interpretation	3
2.	Supply of mATERIALS AND PrROCESS Know-How	5
3.	Ownership of Property and Intellectual Property	6
4.	Licences	6
5.	Payments	7
6.	Royalty Procedures	7
7.	Liability and Warranties	8
8.	Confidentiality	10
9.	TERM AND TERMINaTION	11
10.	Assignment	12
11.	Governing Law and Dispute Resolution	13
12.	Force Majeure	13
13.	Illegality	14
14.	Miscellaneous	14
15.	Notice	15

APPENDIX

Materials and Process Know-How

Permitted Sublicensee

CONFIDENTIAL

LONZA

THIS AGREEMENT is made the 13 ^th day of April 2016

BETWEEN

LONZA SALES AG incorporated and registered in Switzerland whose registered office is at Muenchensteinerstrasse 38, CH-4002, Basel, Switzerland (hereinafter referred to as "Lonza"),

and

HEMISPHERX BIOPHARMA, INC of One Penn Center, 1617 JFK Blvd., Suite 500, Philadelphia, PA 19103, USA (hereinafter referred to as " Licensee ")

The Licensee and Lonza shall hereinafter jointly be referred to as the “ Parties ” and individually as the “ Party ”.

WHEREAS

Lonza is the licensed proprietor of the {***} and related process know-how for manufacture of the {***} and has the right to grant certain Intellectual Property Rights in relation thereto (all as hereinafter defined), and

The Licensee wishes to take a sub licence under Lonza Intellectual Property Rights to use the {***} in its internal processes for the commercial manufacture and subsequent exploitation of Product (as hereinafter defined).

Lonza has agreed to grant Licensee a sub license to the {***} and the {***} for the purpose of the commercial manufacture and sale of Product subject to the terms of this Agreement

NOW THEREFORE the Parties hereby agree as follows:

Definitions and Interpretation

1.1

In this Agreement the following words and phrases shall have the following meanings:

1.1.1

“ Affiliate ” means any company, corporation, limited liability company, partnership or other entity which directly or indirectly controls, is controlled by or is under common control, directly or indirectly, with the relevant Party to this Agreement. "Control" means the ownership of more than fifty percent (50%) of the issued share capital of the party in question or the legal power to direct or cause the direction of the general management and policies of the party in question. Such entity shall be deemed an Affiliate only so long as it satisfies the foregoing definition.

1.1.2

“ {***} ” means {***}

1.1.3

“ {***} " means {***} .

CONFIDENTIAL

LONZA

1.1.4

“Confidential Information” means any Know-How and confidential information disclosed by one Party to the other in connection with this Agreement including for the avoidance of doubt the terms of this Agreement itself. In the case of Lonza, Confidential Information shall mean all information relating to the {***} , the {***} and any other materials, specifications or information which is provided and/or disclosed by Lonza, its Affiliates and their respective officers, employees, agents and advisors to the Licensee and its officers, employees, agents and advisors, whether directly or indirectly.

1.1.5

“Effective Date” means the date first above written.

1.1.6

“Intellectual Property Rights” means all rights, title and interests, vested and/or arising out of any industrial or intellectual property, whether protected at common law or under statute, which includes (without limitation) any rights and interests in copyrights, designs, trademarks, servicemarks, trade-names, technology, business names, logos, commercial symbols, processes, developments, licenses, trade secrets, goodwill, drawings, computer software, formulae, technical information, research data, procedures, designs, Confidential Information and any other knowledge of any nature whatsoever throughout the world whether in existence today or which will come into existence in the future, and including all applications for patents, copyrights, trademarks, trade names, rights to apply and any amendments/modifications or renewals thereto; and all other intellectual property rights.

1.1.7

“ Materials ” means the materials relating to the {***} particulars of which are set out in Appendix 1 hereto.

1.1.8

“Know-How” means any technical and other information, whether patented or unpatented, including, but without prejudice to the generality of the foregoing, ideas, concepts, trade secrets, know-how, inventions, discoveries, data, formulae, specifications, processes, procedures for experiments and tests and other protocols, results of experimentation and testing, fermentation and purification techniques and assay protocols.

1.1.9

“Net Sale” {***} .

1.1.10

“ Permitted Sublicensee ” means one or more of the third parties listed in Appendix 2 to which Licensee grants a sublicence of the rights granted to Licensee pursuant to this Agreement.

1.1.11

“Product” means the therapeutic agent of which Licensee is the proprietor manufactured utilizing Materials.

1.1.12

“Process” means the process for producing the {***} from the {***} as developed by Lonza.

1.1.13

“Process Know-How” means Know-How relating directly or indirectly to the Process known to Lonza from time to time, of which Lonza is the proprietor or licensed proprietor as set out in Appendix 1 hereto to the extent that Lonza is able to locate and provide the same to Licensee without incurring material cost or significant consumption of resources and labour.

CONFIDENTIAL

LONZA

1.1.13

“Territory” means world-wide.

1.2

The headings of this Agreement are inserted only for convenience and shall not affect the construction hereof.

1.3

Where appropriate words denoting a singular number only shall include the plural and vice versa.

1.4

References to the recitals, clauses and appendix shall be deemed to be a reference to the recitals, clauses and appendix to this Agreement and shall form an integral part of this Agreement.

1.5

References to any statute or statutory provision include a reference to the statute or statutory provision as from time to time amended, extended or re-enacted.

1.6

Reference in this Agreement to Lonza shall, unless repugnant to the subject or context thereof, include its Affiliates, successors and assigns.

Supply of Materials and Process Know-How

2.1

Unless previously supplied by Lonza under a separate agreement, Lonza shall, if requested by Licensee in writing, arrange for the supply ex-works Lonza’s premises, Lonza to Licensee of the following:

2.1.1

Process Know-How, including transfer of ownership of the DMF pertaining to the Product on file with the U.S. Food and Drug Administration, solely for the purpose of obtaining and supporting approval to manufacture and sell the Product in the Territory.

2.1.2

the Materials for use by Licensee in accordance with the terms of this Agreement.

2.2

In the event that Licensee requires any additional quantities of the Materials and if Lonza at its sole discretion is willing to supply such additional Materials, such supply shall be subject to the payment of an additional fee by Licensee to Lonza in accordance with Lonza’s prices at the time.

2.3

For the avoidance of doubt, any Materials or Process Know How supplied prior to the Effective Date shall be deemed to be Materials and Process Know How (as applicable) hereunder and shall be treated accordingly with effect from the Effective Date.

2.4

Any transportation of the Materials by Lonza on behalf of Licensee shall be made at sole risk of the Licensee who shall be deemed to have full knowledge of the carrier’s terms and conditions of carriage (“Carriage Terms” ). The Licensee shall, as appropriate, observe, perform, and be subject to the Carriage Terms in relation to the transportation of the Materials and shall indemnify Lonza against all losses, expenses, demands, claims, actions, judgements, assessments, damages, liabilities, fines, penalties, costs and fees incurred by Lonza by reason of Licensee’s failure to observe and perform the Carriage Terms.

CONFIDENTIAL

LONZA

Ownership of Property and Intellectual Property

3.1

It is hereby acknowledged and agreed that as between the Parties any and all property and Intellectual Property Rights in the {***} , the {***} , the Process and Process Know-How is vested in Lonza. Similarly it is hereby acknowledged as between the Parties any and all Intellectual Property Rights in the Product, and the Licensee’s manufacturing process utilizing the {***} or the {***} as part of the process for manufacturing the Product, is vested in Licensee, or its applicable licensors and sublicensees.

3.2

The provisions of this Clause 3 shall survive termination of this Agreement.

Licences

4.1

Lonza hereby grants to Licensee and its Affiliates on the Effective Date

(a)

a non-exclusive licence to use the Process Know-How to develop, manufacture, market, and sell Product in the Territory; and

(b)

a non-exclusive licence in the Territory to use the Materials to develop, manufacture, market and sell Product in the Territory.

4.2

The Licensee shall not use the Materials or cause or permit the Materials to be used other than for the manufacture of Product and undertakes not to make any modifications or adaptations to the Materials.

4.3

Save as provided and permitted in clauses 4.4 and 4.5 below the Licensee shall not be entitled to grant a sublicence to the rights granted by Clause 4.1 which are otherwise deemed to be personal to Licensee and its Affiliates

4.4

Notwithstanding the restriction in Clause 4.3 but subject to the requirements in Clause 4.6 Licensee shall be entitled to sublicense the rights granted in Clause 4.1 to one or more of the Permitted Sublicensee’s listed in Part 1 of Appendix 2 for the sole purpose of undertaking testing of the Product on behalf of Licensee. .

4.5

Notwithstanding the restriction in Clause 4.3 but subject to the requirements in Clause 4.6 Licensee shall be entitled to sublicense the rights granted in Clause 4.1 to one or more of the Permitted Sublicensees listed in Part II of Appendix 2 for the development and/or manufacture of Product for and on behalf of Licensee.

4.6

The following terms and conditions shall apply in respect of any sublicense granted by the Licensee to a Permitted Sublicensee:

(a)

Licensee shall ensure that the Permitted Sublicensee’s use of the Process Know-How and Materials is undertaken solely for activities permitted by Clauses 4.4 and 4.5 above and only on behalf of Licensee; and

(b)

The Permitted Sublicensee shall not, by virtue of this Agreement, be granted any right or licence, either express or implied, under any patent or proprietary right vested in Lonza or otherwise, to use the Process Know-How or Materials other than for undertaking the activities permitted by Clauses 4.4 and 4.5 above and only for or on behalf Licensee and Licensee agrees to ensure that such Permitted Sublicensee shall not assign, transfer, further sublicense or otherwise make over the benefit or the burden of the rights granted to it pursuant to this Agreement; and

CONFIDENTIAL

LONZA

(c)

Any sublicence granted shall be granted expressly subject to the terms of this Agreement, and it shall be Licensee’s responsibility to ensure the strict adherence by Permitted Sublicensee hereunder to the terms and conditions of this Agreement and Licensee shall be fully responsible to Lonza and shall indemnify Lonza for any loss, claim or expense resulting from Permitted Sublicensee’s failure to so comply with the obligations in this Clause 4.6.

4.7

No licence is granted save as expressly provided herein and no licence in addition thereto shall be deemed to have arisen or be implied by way of estoppel or otherwise.

Payments

5.1

Signature and Royalty and Signature Fees

In consideration of the licence granted to Licensee pursuant to Clause 4.1 above, Licensee shall pay to Lonza a one-time fee of $ {***} ( {***} dollars) (“Signature Fee”) within 35 (thirty five) days of the Effective Date of this Agreement.

5.2

In consideration of the licence granted to Licensee pursuant to Clause 4.1 above, Licensee shall pay to Lonza in respect of Product manufactured a royalty of {***} percent ( {***} %) of Net Sales of Product.

5.3

The provisions of this Clause 5 shall remain in full force and effect notwithstanding the expiry or sooner determination of this Agreement until the settlement of all subsisting claims under this Clause 5.

Royalty Procedures

6.1

Licensee shall, and shall ensure that its Affiliates shall, keep true and accurate records and books of account containing all data necessary for the calculation of royalties payable to Lonza. Such records and books of account shall, upon reasonable notice having been given by Lonza (which in no event shall be less than thirty (30) days prior notice), be open at all reasonable times during regular business hours for inspection by independent auditors selected by Lonza and reasonably acceptable to Licensee. Such independent auditors shall agree to maintain the confidentiality of the information and materials disclosed during the audit. Any such audit shall be conducted in a manner that does not interfere unreasonably with the operations of Licensee’s business. Lonza may perform an audit once each calendar year. Each audit shall begin upon the date specified by Lonza and shall be completed as soon as reasonably practicable. Lonza shall pay the costs of the independent auditors conducting such audit, unless the results of the audit reveal an underpayment of 5% or more by Licensee, in which case, Licensee shall pay the reasonable costs of the independent auditors. If an audit concludes that an overpayment or underpayment has occurred during the audited period, such payment shall be remitted by the Party responsible for such payment to the other Party within thirty (30) days after the date such auditor’s written report identifying the overpayment or underpayment is delivered to the Party responsible for such payment.

CONFIDENTIAL

LONZA

6.2

Licensee shall prepare a statement within 20 days after the last days of March and September in each year for the six months ended on such date (or part thereof in the first and last year of this Agreement) showing separately in respect of each immediately preceding period details of the sales of Product on a country by country basis and the royalty due and payable to Lonza thereon and where sales relate to a country other than the United Kingdom the rate of exchange used by the Licensee.

Such statement shall be submitted to Lonza together with a remittance for the royalties due to Lonza to which Lonza shall issue a receipted invoice in return.

6.3

All sums due under this Agreement:

6.3.1

shall (save in respect of the Signature Fee) be paid in pounds sterling to Lonza.

6.3.2

are exclusive of any Value Added Tax or of any other applicable taxes, levies, imposts, duties and fees of whatever nature imposed by or under the authority of any government or public authority, and shall be paid by Licensee (other than taxes on Lonza’s income). The parties agree to co-operate in all respects reasonably necessary to take advantage of such double taxation treaties as may be available.

6.4

To the extent that Licensee reports Net Sales otherwise than in pounds sterling then royalty payments due to Lonza shall be first calculated in the local currency in which Net Sales are reported and then shall be converted to a pounds sterling value at the rate of exchange equivalent to the pound spot rate in London first published in the Financial Times on the first business day after the relevant quarterly reporting period.

6.5

Where Lonza does not receive payment of any sum by the due date, interest shall accrue thereafter on the sum due and owing to Lonza at the rate of four percent (4%) per annum over the base rate from time to time of National Westminster Bank plc, interest to accrue on a day-to-day basis without prejudice to Lonza’s right to receive payment on the due date.

Liability and Warranties

7.1

Lonza gives no representation or warranty that the exercise of the rights granted to Licensee hereunder will not infringe intellectual property rights vested in Lonza or any third party provided however that Lonza warrants that Licensee has all necessary rights from Lonza to operate the Process as a stand-alone process meaning in isolation from the Product and other third party know-how and intellectual property.

7.2

As at the date of this Agreement, Lonza has not received notice of any claim by a third party, (a) which affects Lonza’s ability to grant the rights specified in Clause 4.1, or (b) that the use of the Process Know How or the Materials infringes intellectual property rights vested in any third party.

CONFIDENTIAL

LONZA

7.3

The Licensee hereby acknowledges that in order to exploit the rights granted herein the Licensee may require licences under Lonza patent rights (other than those herein licensed) or under Third Party patent rights (including those vested in Affiliates of Lonza) that may be infringed by the use by the Licensee of the rights licensed herein and it is hereby agreed that it shall be the Licensee's responsibility to satisfy itself as to the need for such licences and if necessary to obtain such licences; provided that any such patent rights vested in Lonza or its Affiliates which are necessary for Licensee and its Affiliates to operate the Process as permitted by the terms of this Agreement shall be automatically included within the Intellectual Property Rights licensed to Licensee hereunder.

7.4

Licensee expressly acknowledges and understands that the Materials and the Process Know How are vested in Lonza or Lonza is otherwise entitled thereto and the Materials and the Process Know How have been used by Lonza for the purposes of operating the Process at Lonza’s premises. Licensee further acknowledges and agrees that, in order to develop or manufacture Product at its own or its Affiliate’s premises, additional development work may be required to be undertaken at the cost and expense of Licensee.

No warranties are given by Lonza as to the suitability of the Process Know How or the Materials for use at Licensee’s or its sublicensee’s premises or the extent of development work which may be required in order to enable Licensee to operate the Process and no guarantees are given by Lonza that such development work will succeed in facilitating the operation of the Process to produce Product which meets any particular technical parameters or specifications. All such development work shall be performed at the sole risk and expense of Licensee and/or its sublicensee. Lonza’s sole responsibility hereunder shall be to supply the Process Know How and the Materials in accordance with this Agreement.

7.5

Each Party ( “Indemnifying Party” ) shall indemnify and hold harmless the other Party and its Affiliates, and their respective officers, employees and agents (each an “Indemnified Party”) at all times in respect of any and all losses, damages, costs and expenses (collectively “Losses”) suffered or incurred as a result of any contractual, tortious or other claims or proceedings by Third Parties (collectively “Third Party Claims”) against Indemnified Party arising out of the Indemnifying Party’s breach of this Agreement, including breach of representations and warranties, violation of applicable law, negligence or wilful misconduct; provided that with respect to any Third Party Claim for which each Party is entitled hereunder to seek indemnification from the other Party, each Party as the Indemnifying Party shall indemnify the other Party for its Losses only to the extent of the Indemnifying Party’s relative responsibility for the facts underlying the Third Party Claim .

7.6

With respect to product liability claims or proceedings, the following shall apply: (a) except to the extent provided in (b) below, Licensee shall indemnify and hold harmless Lonza, its Affiliates and their respective officers, employees and agents at all times in respect of any and all losses, damages, costs and expenses suffered or incurred as a result of any tortious claims or proceedings of death or bodily injury relating to the Product, and (b) Lonza shall indemnify and hold harmless Licensee, and its Affiliates and their respective officers, employees and agents at all times in respect of any and all losses, damages, costs and expenses suffered or incurred as a result of any tortious claims or proceedings of death or bodily injury relating to the Product to the extent such claims or proceedings result from defects in the {***} or from Lonza’s breach of this Agreement.

CONFIDENTIAL

LONZA

7.7

Any condition or warranty other than those relating to title which might otherwise be implied or incorporated within this Agreement by reason of statute or common law or otherwise is hereby expressly excluded.

7.8

EXCEPT FOR EITHER PARTY’S BREACH OF CLAUSE 8 HEREOF IN NO EVENT SHALL EITHER PARTY OR THEIR RESPECTIVE AFFILIATES BE LIABLE TO THE OTHER PARTY, THEIR AFFILIATES AND THEIR RESPECTIVE OFFICERS, EMPLOYEES AND AGENTS WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT WHETHER IN CONTRACT IN TORT IN NEGLIGENCE OR FOR BREACH OF STATUTORY DUTY OR OTHERWISE FOR LOSS OF PROFITS, SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES. Nothing in this Agreement shall exclude or limit the liability of either Party for fraud or for death or personal injury caused by its negligence or for any other liability that may not be limited or excluded as a matter of law.

7.9

The terms of this Clause 7 shall survive expiration or termination of this Agreement for whatever reason.

Confidentiality

8.1

Licensee expressly acknowledges that Confidential Information disclosed by Lonza pursuant to this Agreement is supplied in circumstances imparting an obligation of confidence and Licensee shall keep such Confidential Information secure, secret and confidential and undertakes to respect Lonza’s proprietary rights therein and to use the same for the sole purpose of this Agreement and not during the period of this Agreement or at any time for any reason whatsoever to disclose, cause or permit to be disclosed such Confidential Information to any Third Party other than its Affiliates hereunder for use in accordance with the terms of this Agreement. Licensee shall procure that only its employees and employees of its Affiliates hereunder shall have access to Confidential Information and then only on a need to know basis and that all such employees shall be informed of their secret and confidential nature and shall be subject to the same obligations as Licensee and its Affiliates hereunder pursuant to this Clause 8.1.

8.2

Lonza expressly acknowledges and undertakes that any Confidential Information disclosed by the Licensee to Lonza pursuant to this Agreement is disclosed in circumstances imparting an obligation of confidence and Lonza shall keep such Licensee's Confidential Information secure, secret and confidential and undertakes to respect Licensee’s proprietary rights therein and to use the same for the sole purpose of this Agreement and not during the period of this Agreement or at any time for any reason whatsoever disclose and/or cause and/or permit to be disclosed such Licensee's Confidential Information to any Third Party.

8.3

Each Party will restrict the disclosure of Confidential Information to such officers, employees, professional advisers, finance-providers, and consultants of itself and its Affiliates ( “Representatives”) who have been informed of the confidential nature of the Confidential Information and who have a need to know such Confidential Information for the purpose of this Agreement. Prior to disclosure to such persons, the Party in receipt of the Confidential Information shall bind its and its Affiliates’ Representatives to confidentiality and non-use obligations no less stringent than those set forth herein. The receiving Party shall notify the disclosing Party as promptly as practicable of any unauthorized use or disclosure of the Confidential Information.

CONFIDENTIAL

LONZA

8.4

The obligations of confidence referred to in this Clause 8 shall not extend to any information which the receiving Party demonstrates:

8.4.1

is or shall become generally available to the public otherwise than by reason of a breach by the recipient Party of such information of the provisions of this Clause 8;

8.4.2

is known to the recipient Party of such information and is at its free disposal prior to its receipt from the other;

8.4.3

is subsequently disclosed to the recipient Party without obligations of confidence by a Third Party owing no such obligation of confidentiality to the disclosing Party; or

8.4.4

can be demonstrated by competent written evidence as having been independently developed by the recipient of the information in question without access to or use or knowledge of the information of the disclosing Party.

8.5

Notwithstanding the foregoing it is acknowledged between the Parties that Lonza or Licensee may be required to disclose Confidential Information to a government agency for the purpose of any statutory, regulatory or similar legislative requirement applicable to the production of Product, or to a court of law or to meet the requirements of any Stock Exchange to which the Parties may be subject. In such circumstances the disclosing Party will inform the other Party prior to disclosure being made as to the nature of the required disclosure, shall only make the disclosure to the extent legally required and shall seek to impose obligations of secrecy wherever possible.

8.6

Each Party hereto expressly agrees that any breach or threatened breach of the undertakings of confidentiality provided hereunder by a Party may cause irreparable harm to the other Party ( “Non-Breaching Party”) and that money damages may not provide a sufficient remedy to the Non-Breaching Party for any breach or threatened breach. In the event of any breach and/or threatened breach, then in addition to all other remedies available at law or in equity, the Non-Breaching Party shall be entitled to seek injunctive relief and any other relief deemed appropriate by the Non-Breaching Party.

8.7

The obligations of both Parties under this Clause 8 shall survive the expiration or termination of this Agreement for whatever reason.

Term and Termination

9.1

Unless terminated earlier in accordance with the provisions of this Clause 9 or Clause 12, this Agreement shall continue in force in each country of the world, until the earlier of (i) date on which the Licensee decides to terminate the sale of Product and confirms the same to Lonza and (ii) the date on which Lonza notifies the Licensee that its licensed rights to the Materials and the Know-How have ceased and/or been determined.

CONFIDENTIAL

LONZA

9.2

Licensee may terminate this Agreement by giving sixty (60) days’ notice in writing to Lonza.

9.3

Either Lonza or Licensee may terminate this Agreement forthwith by notice in writing to the other upon the occurrence of any of the following events:

9.3.1

if the other (which in respect of the Licensee shall include a breach by a Permitted Sublicensee) commits a breach of this Agreement which in the case of a breach capable of remedy shall not have been remedied within thirty (30) days of the receipt by the other of a notice identifying the breach and requiring its remedy

9.3.2

if the other is unable to pay its debts or enters into compulsory or voluntary liquidation (other than for the purpose of effecting a reconstruction or amalgamation in such manner that the company resulting from such reconstruction or amalgamation if a different legal entity shall agree to be bound by and assume the obligations of the relevant Party under this Agreement) or compounds with or convenes a meeting of its creditors or has a receiver or administrator appointed over all or any part of its assets or takes or suffers any similar action in consequence of a debt, or ceases for any reason to carry on business.

9.4

If this Agreement expires or is terminated for any reason any and all licences granted hereunder shall terminate with effect from the date of termination and Licensee shall destroy all Materials and all Confidential Information which is provided by Lonza (including all Process Know-How) forthwith and shall certify such destruction immediately thereafter in writing to Lonza provided however that the Licensee and its Affiliates shall have the right to sell or otherwise dispose of all Product then on hand, subject to the payment of royalties and the other terms of this Agreement.

9.5

Termination for whatever reason or expiration of this Agreement shall not affect the accrued rights of the Parties arising in any way out of this Agreement as at the date of termination. The right to recover damages against the other and all provisions which are expressed to survive this Agreement shall remain in full force and effect.

10.

Assignment

10.1

The Licensee shall not be entitled to assign, transfer, charge or in any way make over the benefit and/or the burden of this Agreement. Lonza shall not be entitled to assign, transfer, charge or in any way make over the benefit and/or the burden of this Agreement without the prior written consent of the Licensee which consent shall not be unreasonably withheld or delayed, save that Lonza shall be entitled without the prior written consent of the Licensee to assign, transfer, charge, sub-contract, deal with or in any other manner make over the benefit and/or burden of this Agreement (i) to an Affiliate or (ii) to any joint venture company of which Lonza is the beneficial owner of at least fifty percent (50%) of the issued share capital thereof or (iii) to any company with which Lonza may merge or (iv) to any company to which Lonza may transfer its assets and undertaking.

CONFIDENTIAL

LONZA

10.2

This Agreement shall be binding upon the successors and assigns of the parties and the name of a Party appearing herein shall be deemed to include the names of its successors and assigns provided always that nothing herein shall permit any assignment by either Party except as expressly provided herein.

11.

Governing Law and Dispute Resolution

11.1

The validity, construction and performance of this Agreement shall be governed by English law to which the Parties submit.

11.2

Subject to Clause 11.3, the Courts of England and Wales shall have exclusive jurisdiction in relation to this Agreement provided that the Parties shall have the right to proceed to a suitable jurisdiction for the purpose of enforcing a judgment, award, or order (including without limitation seeking specific performance) and injunctive reliefs.

11.3

Any dispute arising between the Parties under this Agreement may upon the mutual agreement of the Parties be referred to and finally settled by arbitration under the Rules of Arbitration of the International Chamber of Commerce by a single arbitrator knowledgeable in biopharmaceutical research and development related matters and familiar with the biopharmaceutical industry, appointed in accordance with the said Rules. The place of arbitration shall be London, England and the arbitration shall be conducted in the English language. The arbitrator’s award shall be final and binding. The Parties covenant and agree that they will participate in the arbitration in good faith and that they will share equally the costs of the arbitration, except as otherwise provided herein. Any Party refusing to comply with an order of the arbitrator will be liable for costs and expenses, including attorney’s fees, incurred by the other Party in enforcing an award.

12.

Force Majeure

Neither Party shall be in breach of this Agreement if there is any total or partial failure of performance by it of its duties and obligations under this Agreement occasioned by any act of God (including without limitation, fire), act of government or state, war, civil commotion, insurrection, embargo, epidemic, terrorism or earthquake, prevention from or hindrance in obtaining any raw materials, energy or other supplies, labour disputes of whatever nature and any other reason beyond the control of either Party. If either Party is unable to perform its duties and obligations under this Agreement as a direct result of the effect of one of the reasons set out in this Clause 12 such Party shall give written notice to the other of such inability stating the reason in question. The operation of this Agreement shall be suspended during the period (and only during the period) in which the reason continues. Forthwith upon the reason ceasing to exist the Party relying upon it shall give written notice to the other of this fact. If the reason continues for a period of more than ninety (90) days and substantially affects the commercial basis of this Agreement the Party not claiming under this Clause 12 shall have the right to terminate this Agreement by giving written notice of such termination to the other Party.

CONFIDENTIAL

LONZA

13.

Illegality

13.1

If any provision or term of this Agreement or any part thereof shall become or be declared illegal, invalid or unenforceable for any reason whatsoever including but without limitation by reason of the provisions of any legislation or other provisions having the force of law or by reason of any decision of any Court or other body or authority having jurisdiction over the parties hereto or this Agreement including the EC Commission or the European Court of Justice:

(i)

such provision shall, so far as it is illegal, invalid or unenforceable, be given no effect by the Parties and shall be deemed not to be included in this Agreement;

(ii)

the other provisions of this Agreement shall be binding on the Parties as if such provision was not included therein; and

(iii)

the Parties agree to negotiate in good faith to amend such provision to the extent possible for incorporation herein in such reasonable manner as most closely achieves the intention of the Parties without rendering such provision invalid or unenforceable.

14.

Miscellaneous

14.1

This Agreement embodies and sets forth the entire agreement and understanding of the parties and supersedes all prior oral and written agreements, representations, misrepresentations (where innocently or negligently made), understandings or arrangements relating to the subject matter of this Agreement ( “Understandings”). Neither Party shall be entitled to rely on any Understandings which are not expressly set forth in this Agreement.

14.2

This Agreement shall not be amended, modified, varied or supplemented except in writing signed by duly authorised representatives of the Parties.

14.3

No failure or delay on the part of either Party hereto to exercise any right or remedy under this Agreement shall be construed or operated as a waiver thereof nor shall any single or partial exercise of any right or remedy under this Agreement preclude the exercise of any other right or remedy or preclude the further exercise of such right or remedy as the case may be. The rights and remedies provided in this Agreement are cumulative and are not exclusive of any rights or remedies provided by law.

14.4

Except as required by law, the text of any press release or other communication to be published by or in the media whether of a scientific nature or otherwise and concerning this Agreement shall require the prior written approval of Lonza and Licensee.

14.5

Each of the Parties shall be responsible for its respective legal and other costs incurred in relation to the preparation of this Agreement.

14.6

The Parties do not intend that any term hereof should be enforceable by virtue of the Contracts (Rights of Third Parties) Act 1999, or by any other statute or common-law principle, by any person who is not a party to this Agreement.

CONFIDENTIAL

LONZA

15.

Notice

15.1

Any notice or other document to be given under this Agreement shall be in writing and shall be deemed to have been duly given if left at or sent by registered post or by a reputable overnight courier to a Party or delivered in person to a Party at the address set out below for such Party or such other address as the Party may from time to time designate by written notice to the other(s):

Address of Lonza

LONZA SALES AG, Muenchensteinerstrasse 38 CH-4402, Basel, Switzerland

	With a copy to:	Lonza Biologics Plc
		228 Bath Road, Slough, Berkshire SL1 4DX
		Facsimile: 01753 777001
		For the attention of the Head of Legal Services

Address of Licensee

HEMISPHERX BIOPHARMA, INC of One Penn Center, 1617 JFK Blvd., Suite 500, Philadelphia, PA 19103, USA Facsimile: (215) 988-1739

For the attention of: Wayne Springate

15.2

All such notices and documents shall be in the English language. Any such notice or other document shall be deemed to have been received by the addressee seven (7) working days following the date of dispatch of the notice or other document by post or, where the notice or other document is sent by hand, at the time of such delivery. To prove the giving of a notice or other document it shall be sufficient to show that it was dispatched.

CONFIDENTIAL

LONZA

AS WITNESS the hands of the duly authorised representatives of the parties hereto

Signed for and on behalf of	s/JG
LONZA SALES AG
	Julien Gender,
	Senior Legal Counsel	TITLE

Signed for and on behalf of	s/CA
LONZA SALES AG
	Cordula Alterkruger,
	Senior Legal Counsel	TITLE

Signed for and on behalf of	s/WS
HEMISPHERX BIOPHARMA, INC
	Wayne Springate
	Senior Vice President of Operations

CONFIDENTIAL

LONZA

APPENDIX 1

MATERIALS AND PROCESS KNOW-HOW

Materials

{***}

Process Know-How

The following Process Know-How will be made available to Licensee for use in accordance with the terms of the Agreement: {***}

CONFIDENTIAL

LONZA

APPENDIX 2

PERMITTED SUBLICENSEE

PART I

(TESTING LABORATORIES)

{***}

PART II

(THIRD PARY CONTRACT MANUFACTURERS)

EXHIBIT 31.1

CERTIFICATIONS PURSUANT TO SECTION 302 OF SARBANES-OXLEY ACT OF 2002

I, Thomas K. Equels certify that:

I have reviewed this this amendment No. 1 to the quarterly report on Form 10-Q of Hemispherx Biopharma, Inc. (the “Registrant”);

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;

The Registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

Evaluated the effectiveness of the Registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

Disclosed in this report any change in the Registrant's internal control over financial reporting that occurred during the Registrant's most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Registrant's internal control over financial reporting; and

The Registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant's auditors and the audit committee of the Registrant's board of directors (or persons performing the equivalent functions):

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant's ability to record, process, summarize and report financial information; and

Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant's internal control over financial reporting.

Date: August 29, 2016

	/s/ Thomas K. Equels
	Thomas K. Equels, Esq.
	Chief Executive Officer

EXHIBIT 31.2

CERTIFICATIONS PURSUANT TO SECTION 302 OF SARBANES-OXLEY ACT OF 2002

I, Adam Pascale, certify that:

I have reviewed this this amendment No. 1 to the quarterly report on Form 10-Q of Hemispherx Biopharma, Inc. (the “Registrant”);

Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant's internal control over financial reporting.

Date: August 29, 2016

	/s/ Adam Pascale
	Adam Pascale
	Chief Financial Officer