HEMISPHERX BIOPHARMA, INC. (NYSEMKT:HEB) Files An 8-K Entry into a Material Definitive Agreement

Item 1.01 Entry into a Material Definitive Agreement.

On May 24, 2016, we entered into an amended and restated five
year agreement (the Impatients Agreement) with Impatients, N.V.
(myTomorrows), a Netherlands based company, for the commencement
and management of an Early Access Program (EAP) in Europe and
Turkey (the Territory) related to CFS. to the agreement,
myTomorrows, as our exclusive service provider and distributor in
the Territory, is performing EAP activities. These activities
will be directed to (a) the education of physicians and patients
regarding the possibility of early access to innovative medical
treatments not yet the subject of a Marketing Authorization
(regulatory approval) through named-patient use, compassionate
use, expanded access and hospital exemption, (b) patient and
physician outreach related to a patient-physician platform, (c)
the securing of Early Access Approvals (exemptions and/or waivers
required by regulatory authorities for medical treatments prior
to Marketing Authorization) for the use of such treatments, (d)
the distribution and sale of such treatments to such Early Access
Approvals, (e) pharmacovigilance (drug safety) activities and/or
(f) the collection of data such as patient-reported outcomes,
doctor-reported experiences and registry data. We are supporting
these efforts and supplying Ampligen to myTomorrows at a
predetermined transfer price. In the event that we receive
Marketing Authorization in any country in the Territory, we will
pay myTomorrows a royalty on products sold. to the Impatients
Agreement, the royalty would be a percentage of Net Sales (as
defined in the Impatients Agreement) of Ampligen sold in the
Territory where Marketing Authorization was obtained, and the
maximum royalty would be a percentage of Net Sales. The formula
to determine the percentage of Net Sales will be based on the
number of patients that are entered into the EAP. The Company
believes that disclosure of the exact maximum royalty rate and
royalty termination date could cause competitive harm. However,
to assist the public in gauging these terms, the actual maximum
royalty rate is somewhere between 2% and 10% and the royalty
termination date is somewhere between 8 and 15 years from the
First Commercial Sale of a product within a specific country. The
parties established a Joint Steering Committee comprised of
representatives of both parties to oversee the EAP. No assurance
can be given that activities under the EAP will result in
Marketing Authorization or the sale of substantial amounts of
Ampligen in the Territory. In 2017, the Company commenced sales
of recently manufactured Ampligen in international programs.

The foregoing description of the Agreement is qualified in its
entirety by reference to the full text of the Agreement, a copy
of which is attached hereto as Exhibit 10.1, and which is
incorporated herein in its entirety by this reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No. Description

10.1May 20, 2016 Amended And Restated Early Access Agreement with
Impatients N.V.*

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

About HEMISPHERX BIOPHARMA, INC. (NYSEMKT:HEB)

Hemispherx Biopharma, Inc. (Hemispherx) is a specialty pharmaceutical company. The Company is engaged in the clinical development of drug therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders. The Company’s segment is engaged in research and development activities related to Ampligen and other drugs under development, and sales and marketing of Alferon. The Company’s products include Alferon N Injection and Ampligen. Alferon N Injection is approved for the use in intralesional treatment of refractory or recurring external genital warts in patients of over 18 years of age. Ampligen is a drug undergoing clinical development for the treatment of Chronic Fatigue Syndrome (CFS). Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) is a low-dose, oral liquid formulation of natural alpha interferon. Alferon LDO is a liquid natural interferon for oral administration.

HEMISPHERX BIOPHARMA, INC. (NYSEMKT:HEB) Recent Trading Information

HEMISPHERX BIOPHARMA, INC. (NYSEMKT:HEB) closed its last trading session down -0.010 at 0.630 with 121,888 shares trading hands.