STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
December 13, 2007
HEMISPHERX BIOPHARMA, INC.
(Exact name of registrant as specified in its charter)
Delaware 0-27072 52-0845822
(state or other jurisdiction (Commission File (I.R.S. Employer
of incorporation) Number) Identification No.)
1617 JFK Boulevard, Philadelphia, Pennsylvania 19103
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (215) 988-0080
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(former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Securities Act (17 CFR
230.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act (17 CFR 240-14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange
Act (17CFR 240-13e-4(c))
Section 1 - Registrant's Business and Operations.
Item 1.01 Entry into a Material Definitive Agreement
On December 13,2007 we entered into a licensing/research agreement with BIKEN
(the non-profit operational arm of the Foundation for Microbial Diseases of
Osaka University), to use our experimental drug Ampligen(R)as an immune enhancer
in influenza vaccine. Refer to the attached ehibits for more information.
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits
10.1 Biken Activating Agreement.
10.2 Biken Material Evaluation Agreement.
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 hereunto duly authorized.
HEMISPHERX BIOPHARMA, INC.
December 14, 2007 By: /s/ William A. Carter
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William A. Carter, M.D.
Chief Executive Officer
Exhibit 10.1
Activating Agreement
This Agreement is made by and between Hemispherx Biopharma, Inc. (hereinafter
referred to as "Hemispherx") and The Research Foundation for Microbial Diseases
of Osaka University (hereinafter referred to as "Biken").
RECITALS
WHEREAS, Hemispherx owns intellectual property rights relating to poly I: poly
C12U, with the trade name of Ampligen(R) and possesses proprietary rights and
know-how relating to the manufacture and production of Ampligen(R); and
WHEREAS, Biken is a manufacturer of biologicals in Japan, and has been engaged
for many years mainly in the research and development and manufacture of a
variety of infection-prophylactic vaccine products for human use. As part of the
work activities relating to a research project entitled "The Research Project on
Clinical Application of the Influenza Virus Vaccine in the Intranasal Dosage
Form for Mucosal Administration" (hereinafter referred to as the "Research
Project"), which is subsidized by the Japanese Ministry of Health, Labor and
Welfare (hereinafter referred to as the MHLW") and in which the National
Institute of Infectious Diseases of Japan (hereinafter referred to as the
"NIID") plays a main part and Biken also participates as one of the researchers
and during and in the course of which, at the end of each fiscal year research
results obtained thereby are to be compiled by the NIID into an annual research
report that will be submitted to the MHLW and subsequently place,,, for public
view, Biken has an intention to evaluate the functional capability of
Ampligen(R) in serving as an adjuvant to induce mucosal immune response. In
addition, Biken owns jointly with the NIID the intellectual property rights
relating to the "Novel Vaccine Containing Adjuvant Capable of Inducing Mucosal
Immunity", which is the object substance of the Research Project, and possesses
the technical know-how to prepare prototypes of such adjuvanted vaccine
preparation for experimental and research purposes, and
WHEREAS, Hemispherx and Biken have entered into a Material Evaluation Agreement
of even date herewith ("MEA") which provides for an Evaluation Program as
defined and described therein.
NOW THEREFORE, in consideration of the mutual covenants and agreements made
herein, and for other good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the Parties agrees as follows:
1. The Collaboration Agreement attached hereto as Exhibit 1, together with all
of its terms and provisions, shall, without further act by the parties or either
of them, become activated, operative and effective upon completion of the
Evaluation Program as defined in the MEA with the Evaluation Program's
designated success end points having been achieved.
2. The Parties may at any time by agreement in writing amend the Collaboration
Agreement.
IN WITNESS WHEROF, the Parties have caused this Agreement to be executed by
their duly authorized representatives as of the day and year set forth below.
HEMISPHERX BIOPHARMA, INC. THE RESEARCH FOUNDATION FOR
MICROBIAL DISEASES OF OSAKA UNIVERSITY
/s/ William A. Carter /s/ Yasushi Higashi
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Represented by: Represented by:
Name: William A. Carter, MD Name: Yasushi Higashi, M.D., D.M. Sc.
Title: Chairman of the Board, Title: Chairman , Board of Directors
Chief Executive Officer
Address: Address:
One Penn Center 3-1, Yamada-Oka, Suita,
1617 JFK Blvd. Osaka 565-0871
Philadelphia, PA 19103 Japan
U.S.A.
Date: Dec. 13, 2007 Date: Dec. 12, 2007
Exhibit 1
Collaboration Agreement
This Collaboration Agreement is made as of the Effective Date by and
between The Research Foundation for Microbial Diseases of Osaka University
("Biken") and Hemispherx Biopharma, Inc. ("Hemispherx").
WHEREAS, Hemispherx owns intellectual property rights relating to poly
I: poly C12U, with the trade name Ampligen(R) and possesses proprietary rights
and know-how relating to the manufacture and production of Ampligen(R), and
WHEREAS, Hemispherx and Biken wish to develop and obtain appropriate
regulatory approvals for the commercial sale of "Combined Product(s)"as defined
in Clause 1.5, and following the awarding of appropriate regulatory approvals,
wish to cause the Combined Product(s) to be manufactured, produced and marketed
for administration to patients.
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:
1. Definitions
1.1 "Affiliate" shall mean any entity in whatever country organized
which directly or indirectly owns, is owned by or is under common ownership with
a party to this Collaboration Agreement or any entity actually controlled by,
controlling or under common control of a party to this Collaboration Agreement.
For the purpose of this definition, "ownership" or "control" shall mean where
such entity owns or controls fifty percent (50%) or more of the equity
conferring voting rights and/or otherwise has the ability to direct the business
affairs of another entity.
1.2 "Confidential Information" shall mean and include all present and
future techniques, inventions, practices, knowledge, know-how, skill,
experience, test data, analytical data, pre-clinical and clinical development
data, clinical trial protocols, reports including case report forms, any
applications to any regulatory authority including registration dossiers,
marketing and sales data and descriptions (whether in electronic, documentary,
eye readable or any other form) generated or obtained by either party or
obtained through agreement with a third party with regard to Ampligen(R) and/or
the Prototype Vaccine Preparation and/or Combined Product(s) or disclosed by
either party to the other party and identified as being confidential and
including any reports prepared by either party for the other, excluding,
however, information which:
1.2.1 is or comes into the public domain through no fault of the
receiving party; 1.2.2 is known to the receiving party prior to
the date of disclosure, as evidenced by
written records of that party; or
1.2.3 is lawfully disclosed to the receiving party by a
third party rightfully in possession of it; or
1.2.4 is independently and subsequently developed by an employee
or agent of the receiving party who had no knowledge of the
Confidential Information disclosed under this Collaboration
Agreement or of any Confidential Information derived by the
receiving party therefrom.
1.3 "Ampligen(R)" shall mean poly I: poly C12U.
1.4 "Prototype Vaccine Preparation" shall mean the prototype of
influenza virus vaccine preparation described in Clause (6) of
Article 2 of the Material Evaluation Agreement dated December 13,
2007 by and between Hemispherx and Biken (hereinafter referred
to as "Material Evaluation Agreement").
1.5 "Combined Product(s)" shall mean any influenza virus vaccine in the
form of spray administration, using in any manner Ampligen(R) (either with or
without the addition of other substance(s)) and manufactured, produced, tested
and/or marketed for administration to patients. Of these Combined Products,
"Biken Combined Product(s)" shall mean Combined Product(s) using vaccine
antigens that Biken manufactures by propagating and purifying influenza viral
antigens which Biken produces and that contain inactivated whole virus or HA
antigens (hereinafter referred to as "Biken Vaccine Antigens").
1.6 "Biken Non-Exclusive Licensed Territory" shall mean Japan.
1.7 "Hemispherx Licensed Patents" shall mean:
1.7.1 all Hemispherx patents issued or pending in the Biken
Non-Exclusive Licensed Territory as listed on Exhibit A
attached hereto and made a part hereof.
1.7.2 any division, continuation, or continuation-in-part of any
such application and any patent which shall issue based on
such application, division, continuation or
continuation-in-part;
1.7.3 any patent which is a re-issue or extension of, or patent of
addition or any application maturing into a patent defined
in Clauses 1.7.1 and 1.7.2;
1.7.4 any patent application or patent corresponding to any
patent application or patent defined in Clause 1.7.1, 1.7.2
or 1.7.3 which is hereafter filed or issued in the Biken
Non-Exclusive Licensed Territory.
1.8 "Hemispherx Licensed Know-How" shall mean and be limited to the
information possessed by Hemispherx relating to Ampligen(R) specifications and
its testing in animals and man and the result thereof.
1.9 "Entity" shall mean, and include, any person, firm or company
or group of persons orunincorporated body.
1.10 "Person(s)" include any person, firm or company or group of
persons or unincorporated body.
1.11 Effective Date. "Effective Date" shall mean the date upon which
this Collaboration Agreement is activated and becomes operative and effective in
accordance with the provisions of the Activating Agreement by and between
Hemispherx and Biken.
2. Grant of License
2.1 Hemispherx hereby grants to Biken and Biken hereby accepts a
non-exclusive, non-transferable license to use Hemispherx Licensed Know-How and
the Hemispherx Licensed Patents in order to test, manufacture, have
manufactured, market, have marketed, use and sell Biken Combined Product(s) in
the Biken Non-Exclusive Licensed Territory solely in relation to research for
prevention/treatment of influenza and in relation to prevention/treatment of
influenza.
2.2 Biken may, with prior written notice to and with the written
approval of Hemispherx, which approval shall not be unreasonably withheld,
sub-license the Hemispherx Licensed Know-How and Hemispherx Licensed Patents
under this Collaboration Agreement to any third party in the Biken Non-Exclusive
Licensed Territory for making, using and selling Biken Combined Product(s) or
sub-license the manufacture or marketing thereof, for research for the
prevention/treatment of influenza, and for the prevention/treatment of influenza
in the Biken Non-Exclusive Licensed Territory.
2.3 In the event of sub-licensing as provided for in clauses 2.2, Biken
shall ensure that such third party sub-licensee undertakes in writing to comply
with the terms of this Collaboration Agreement to the extent that such terms are
applicable to it upon the granting of any such sub-license.
2.4 Biken shall guarantee the due and punctual performance of any and
all responsibilities under this Collaboration Agreement as applied to such third
party sub-licensee.
2.5 Hemispherx warrants that Exhibit A attached hereto contains a full
disclosure of the Hemispherx Licensed Patents and all reasonably relevant
information relating thereto and that this disclosure is material to the
execution of this Collaboration Agreement by Biken.
2.6 Hemispherx hereby warrants and represents that it has full right
and power to grant the license set forth in clause 2.1 and that there are no
outstanding agreements, assignments or encumbrances in existence inconsistent
with the provisions of this Collaboration Agreement including without limitation
to generality any obligations to governmental agencies, private foundations,
companies, corporations, individuals or the like resulting from acceptance of
research grant or other monies, or otherwise.
2.7 Hemispherx warrants and undertakes to Biken that it does not know
of any present or proposed litigation in the Biken Non-Exclusive Licensed
Territory concerning Ampligen(R) but it does not warrant that Ampligen(R) will
not infringe the rights of third parties.
2.8 Nothing in this Collaboration Agreement or any Hemispherx license
granted hereunder to Biken is to be construed as a representation or warranty
that Hemispherx Licensed Patents are valid or that use, sale or other dealing or
disposition of Ampligen(R) is not an infringement of any intellectual property
rights in the Biken Non-Exclusive Licensed Territory not owned or controlled by
Hemispherx.
3.0 Know-how
3.1 Hemispherx shall, during the term of this Collaboration Agreement,
supply Biken without any payment by Biken other than the consideration referred
to in Article 5 hereof, all such documents, records, computerized records and/or
other data constituting the Hemispherx Licensed Know-How and Hemispherx hereby
warrants that such Hemispherx Licensed Know-How will be fully disclosed to
Biken.
3.2 The Hemispherx Licensed Know-How supplied by Hemispherx shall be
used by Biken or its sub-licensee solely for the manufacture, use, marketing and
sale of Biken Combined Product(s) in the Biken Non-Exclusive Licensed Territory,
for research for the prevention/treatment of influenza and for the
prevention/treatment of influenza.
3.3 Ownership of the Hemispherx Licensed Know-How supplied by
Hemispherx shall at all times vest in Hemispherx. At Hemispherx's request and
expense, Biken shall either assist Hemispherx in bringing actions against third
parties for an infringement or unlawful appropriation, use or disclosure of the
Hemispherx Licensed Know-How and otherwise in maintaining Hemispherx's rights in
the Hemispherx Licensed Know-How or bring and pursue in its own name all such
actions against the relevant third parties immediately, in the event of its
becoming aware of any such infringement or unlawful appropriation, use or
disclosure, as elected by Biken.
4. Commercial Development and Supply
4.1 Biken shall perform with due diligence its efforts to develop, gain
regulatory approval for commercial sale, commercialize and continue the
commercialization of the Biken Combined Product(s) in the Biken Non-Exclusive
Licensed Territory.
4.2 For a period of three years immediately following the effective
date of this Collaboration Agreement, if reasonably requested in writing by
Biken, Hemispherx shall supply to Biken and/or its sub-licensee at Hemispherx's
cost all Ampligen(R) required by Biken for the development of Biken Combined
Product(s) in the Biken Non-Exclusive Licensed Territory.
5. Consideration
5.1 As consideration for the license hereby granted by Hemispherx to
Biken, Biken shall pay Hemispherx a royalty of two percent (2%) of the amount
received by Biken and any Affiliate of Biken for all sales and/or usage of Biken
Combined Product(s) in the Biken Non-Exclusive Licensed Territory.
5.2 The royalty hereunder shall accrue and be payable to Hemispherx's
designated bank quarterly in arrear, within thirty (30) days after the close of
each calendar quarter following the date of first commercial sales of Biken
Combined Product(s) in the Biken Non-Exclusive Licensed Territory.
5.3 At the same time as payment of any royalties due Biken shall submit
or cause to be submitted to Hemispherx a statement in writing recording the
sales and/or usage of Biken Combined Product(s) within the Biken Non-Exclusive
Licensed Territory during the period to which such royalties relate, the net
invoiced price or value of such sales and/or usages, the direct cost of
production and marketing of such sales and the amount of royalties payable
thereon. In the event that no sales or usage of Biken Combined Product(s) have
been made during any such period in the Biken Non-Exclusive Licensed Territory
Biken shall submit a nil statement.
5.4 Biken shall procure that any sub-licensee shall keep at its usual
place of business, proper detailed records and books of account as may be
necessary to determine the royalties payable hereunder.
5.5 Hemispherx shall have the right, after Biken has received seven (7)
days notice in writing, to instruct a mutually acceptable accountant at any
reasonable time during normal business hours to make such examination of the
books and records of Biken as shall be deemed necessary to verify such records
and books of account pertaining to the sale or use of Biken Combined Product(s)
provided however, that this right may not be exercised twice in any twelve (12)
month period. Said inspection shall disclose to Hemispherx only such information
concerning Biken as pertains to sales of Combined Product(s) and payments or
royalties. Said inspection shall be conducted at the expense of Hemispherx
unless when conducting such an inspection the accountant discovers an error of
more than three percent (3%) in the returns made by Biken since the commencement
of this agreement or the date of the last inspection in which event the cost of
such inspection shall be met by Biken.
5.5.1 Any tax paid or required to be paid or held by Biken for
the account of Hemispherx due to royalty payments to
Hemispherx under this agreement shall be deducted from the
amount of royalty otherwise due. Biken shall secure and
send to Hemispherx proof of any such taxes withheld and
paid by Biken or its sub-licensees for the benefit or on
behalf of Hemispherx.
6. Confidentiality
6.1 Each party undertakes to the other that it shall keep secret and
confidential all Confidential Information communicated to it by the other under
this Collaboration Agreement and shall not disclose the same or any part thereof
to any person whatsoever except as provided in clauses 6.2, 6.3 and 6.4
6.2 Each party may disclose Confidential Information to its directors
or employees or consultants directly or indirectly concerned with Prototype
Vaccine Preparation and Combined Product(s) providing that before any such
disclosure the disclosing party shall procure that each of its directors,
employees and consultants shall execute a confidentiality undertaking in such
form as the other party may reasonably require.
6.3 Biken may disclose Confidential Information to a sub-licensee
properly appointed in accordance with this Collaboration Agreement, provided
that before any such disclosure Biken shall have entered into a confidentiality
undertaking with its sub-licensee on terms no less onerous than the
confidentiality conditions of this Clause 6.
6.4 Biken may disclose to Regulatory Authorities such Confidential
Information as is required to effect the registration of Biken Combined
Product(s).
6.5 In the event that the obligation of confidence imposed by this
Collaboration Agreement is breached by a party to this Collaboration Agreement
either willfully or negligently or carelessly, then the party at fault shall be
responsible to the injured party for all the damages arising from the breach and
communication to the third party of the Confidential Information excluding
indirect, consequential damages and loss of profits.
6.6 Each party shall take all reasonable steps to minimize the risk of
disclosure of Confidential Information and a breach of clause 6:
6.6.1 by ensuring that only employees and representatives whose
duties require them to possess Confidential Information have
access thereto and by instructing such employees and
representatives to treat the same as confidential;
6.6.2 by providing proper and secure storage for papers, drawings
and other confidential material and forbidding unauthorized
persons access to the place or places where these are
stored.
6.7 The provisions in this clause shall remain in force without limit
in time and notwithstanding termination or cancellation of this Collaboration
Agreement.
7. Territorial Restraint
7.1 Biken shall not use the Hemispherx Licensed Know-How or Hemispherx
Licensed Patents, nor sell nor permit the sale of Biken Combined Product(s)
outside the Biken Non-Exclusive Licensed Territory or knowingly sell or have
sold any Biken Combined Product(s) to any party in or outside the Biken
Non-Exclusive Licensed Territory for export or sale outside the Biken
Non-Exclusive Licensed Territory, without Hemispherx's prior written consent.
8. Patents
8.1 Hemispherx agrees to maintain faithfully the licensed patents in
the Biken Non-Exclusive Licensed Territory as reflected in Exhibits A and pay
all taxes, annuities, maintenance fees and the like to ensure that the licensed
patents are legally maintained.
8.2 Biken shall promptly notify Hemispherx of any infringement of the
Hemispherx Licensed Patents, within the Biken Non-Exclusive Licensed Territory,
misappropriation of a trade secret or declaration of an interference proceeding
relating to the Hemispherx Licensed Patents or Hemispherx Licensed Know-How and
shall provide Hemispherx with all available evidence relating thereto.
8.2.1 Biken and Hemispherx will immediately consult with each
other as to the best manner to proceed.
8.2.2 Hemispherx shall have the right, but not the obligation, to
bring, defend and maintain any appropriate suit or action.
If Hemispherx requests Biken to join in such suit or action
and Biken agrees to do so, Biken shall execute all papers
and perform such acts as may be reasonably required and may,
at its option be represented by counsel of its choice.
Hemispherx and Biken shall each be responsible for their own
expenses (including legal fees) in connection with any such
suit or action. Should Hemispherx lack standing to bring any
such action, then Hemispherx may cause Biken to do so upon
first undertaking to indemnify and hold Biken harmless (to
the extent permissible by law) from all consequent liability
and promptly to reimburse all reasonable expenses (including
legal fees) stemming therefrom.
8.2.3 If Hemispherx fails to take action with respect to such
matters within a reasonable period, but in any event, not
more than one hundred and twenty (120) days following
receipt of such notice and evidence, Biken shall have the
right, but not the obligation, to bring, defend and maintain
any appropriate suit or action. If Biken finds it necessary
to join Hemispherx in such suit or actions, Hemispherx shall
execute all papers and perform such acts as may be
reasonably required and may, at its option, be represented
by counsel of its choice. Biken shall pay Hemispherx the
reasonable expenses of Hemispherx (including its legal fees)
in connection with any such suit or action.
8.2.4 In the absence of any agreement between the parties to
jointly bring any action or suit hereunder and share the
expenses thereof, any amount recovered in any such action or
suit shall be retained by the party bearing the expenses
thereof.
9. Improvements
9.1 Any improvement or technical advances made in or grant of further
Letter Patent in respect of the Hemispherx Licensed Patents or Hemispherx
Licensed Know-How by Hemispherx shall forthwith be disclosed to Biken, whether
the subject of Letter Patent or not. For the avoidance of doubt, this disclosure
shall not constitute the grant of a license to use or exploit such improved or
advanced patents or know-how or to manufacture, use or sell improved or advanced
Combined Product(s).
10. Force Majeure
10.1 "Force Majeure" shall be deemed to have prevented,
restricted or interfered with the performance by a party hereto of any of its
obligations hereunder if such event occurs by reason of flood, fire, explosion,
strike, war, revolution, civic commotions, political riot, acts of public
enemies, blockade or embargo or sanctions or any law, interdict, order
proclamation, regulation, ordinance, demand or requirements of any government.
Where the party so affected shall be excused from such of its obligations
hereunder as it is unable to perform to the extent of Force Majeure, it shall be
excused for so long as such prevention, restriction or interference shall remain
in force plus a reasonable period thereafter. Notwithstanding the foregoing,
should Force Majeure continue for an unbroken period of twelve (12) months then
either party shall be entitled to terminate this Collaboration Agreement
forthwith by giving written notice to the other.
10.2 Neither party shall be held responsible for damages
caused by any delay or default due to force majeure.
11. Non Agency
Each party shall operate under this Collaboration Agreement as an
independent contractor. Nothing contained in this Collaboration Agreement or
done hereunder shall be construed as constituting either party the agent or
partner of the other in any sense of that term or for any purpose whatsoever and
neither party shall be entitled to bind the other to any third party.
12. Duration And Termination
12.1 This Collaboration Agreement shall come into effect on the
effective date and shall remain in full force and effect, subject to the
provisions of clause 12.2 hereof, for the life of the Hemispherx Licensed
Patents and for three (3) years after the expiry of the last of the Hemispherx
Licensed Patents in the Biken Non-Exclusive Licensed Territory.
12.2 Anything herein to the contrary notwithstanding, either party
shall have the right to terminate this Collaboration Agreement by notice of
termination in writing to the other party in the event that the commercial sales
of Combined Product(s) prove to be unrealizable both in Biken Non-Exclusive
Licensed Territory. Neither of the parties hereto shall have any responsibility
or liability for or in connection with the termination of this Agreement
pursuant to this clause.
12.3 In the event that Biken or Hemispherx (the "defaulting party")
shall:
12.3.1 default in a material obligation hereunder including
failure to make any
payments, and fail to remedy such default within sixty (60)
days after receipt by the defaulting party of written notice
by the non-defaulting party calling upon it to remedy such
default; or
12.3.2 be voluntarily or compulsorily liquidated, and
whether provisionally or
finally or commit any act of insolvency; or
12.3.3 suffer the appointment of a receiver for any substantial
portion of its business who shall not be discharged
within sixty (60) days after such receiver's
appointment; or
12.3.4 have any judgment granted against it and not have such
judgment set aside within fourteen (14) days after such
judgment has come to its notice;
then and in such event, the non-defaulting party, at its option,
may with immediate effect terminate its obligations to and the rights of the
defaulting party under the license granted in this Collaboration Agreement and
cancel this Collaboration Agreement by written notice to the defaulting party.
12.4 In the event of the cancellation or termination of this
Collaboration Agreement under clause 12.2 or 12.3 howsoever arising.
12.4.1 Biken shall return promptly to Hemispherx all Hemispherx
Licensed Know-How and shall co-operate with Hemispherx in
the cancellation of all or any rights and licenses
registered pursuant hereto and shall execute and do all
such documents, acts and things as may be necessary in
such connection;
12.4.2 Hemispherx shall automatically have the right to take an
absolute assignment of Biken's rights in terms of any
sub-license granted hereunder and Biken hereby irrevocably
appoints Hemispherx its attorney for the purpose of
notifying any sub-licensee of such a change and of signing
any document or doing any act to perfect such assignment.
12.5 Notwithstanding the termination of a party's obligations to or the
rights of the defaulting party under this Collaboration Agreement in accordance
with clauses 12.2 and/or 12.3, the provisions of clause 6 shall survive such
termination and continue in full force and effect without limit in time.
12.6 Nothing contained herein shall limit any remedies available to
either party at law or in equity for the default of the other party under clause
12.3. Termination shall not excuse the obligations of either party to pay money
due to the other party.
13. Successors and Assigns
The rights and obligations of Biken and Hemispherx shall bind and inure
to the benefit of their successors and assigns who shall be bound by the terms
of this Collaboration Agreement.
14. Headings
The headings of the clauses of this Collaboration Agreement have been
inserted only to facilitate reference and shall not be taken as being of any
significance whatsoever in the construction and interpretation of this
Collaboration Agreement.'
15. General
15.1 No waiver by either party of a provision hereof or default
hereunder shall be deemed a waiver of any other provisions or default.
15.2 Any notices or communications to or from the respective parties
required or permitted to be given hereunder shall be deemed to have been
received:
15.2.1 if mailed by registered prepaid airmail to the recipient
at the address given herein and the date of receipt shall
be deemed to be fourteen (14) working days after date of
mailing unless the contrary can be proved;
15.2.2 if sent be telefax to the recipient at the number given
herein and evidence exists of receipt thereof on the next
business day of the recipient after sending unless the
contrary can be proved and provided that such telefax
message is confirmed by registered prepaid post;
15.3 This Collaboration Agreement embodies the entire Collaboration
Agreement between the parties. On the Effective Date hereof, it supersedes any
previous agreement the parties may have in respect of the subject matter.
Neither party shall assert that it had an understanding inconsistent with, or
that goes beyond, or falls short of, any provision herein. No change in terms of
this Collaboration Agreement or the consensual cancellation thereof shall be
effective as to either party hereto unless reduced to writing and signed by all
the parties hereto.
15.4 Biken and Hemispherx shall, at their own expense in the respective
countries, take such steps as may be required to satisfy the laws and
requirements of the respective countries with respect to declaring, recording
and otherwise rendering this Collaboration Agreement valid.
15.5 If any provision of this Collaboration Agreement is found by any
court of competent jurisdiction to be invalid or unenforceable for any reason
whatsoever, this shall not in itself be deemed to affect the other provisions
thereof and such invalid or unenforceable clause shall be severable from the
remaining terms of this Collaboration Agreement.
16. RESOLUTION OF DISPUTE
16.1 Any dispute at any time between the Parties hereto arising out of
or pursuant to this Agreement or its interpretation, rectification, breach or
termination shall, if not resolved through negotiations between the Parties, be
finally settled by arbitration. Arbitration shall be conducted in the United
States pursuant to the rules of the American Arbitration Association in New
York, New York, U.S.A. if Hemispherx is the respondent, and in Tokyo, Japan
pursuant to the Commercial Arbitration Rules of the Japan Commercial Arbitration
Association if BIKEN is the respondent.
16.2 The decision of the arbitrator shall be final and binding and
shall be capable of being made an order of any court having jurisdiction over
any of the Parties.
16.3 This Agreement shall be governed by and construed in accordance
with the laws of the State of Delaware, United States of America without regard
to the conflicts of laws, rules or principles thereof.
17. Domicilia
17.1 The parties hereto choose domicilia citandi et executandi for all
purposes in terms of this Collaboration Agreement as follows:
17.1.1 The Research Foundation for Microbial Diseases of Osaka University
3-1, Yamada-Oka, Suita
Osaka, 565-0871, Japan
Telephone: +81-6-6877-4804
Telefax: +81-6-6876-1984
17.1.2 Hemispherx Biopharma, Inc.
One Penn Center
1617 JFK Blvd.
Philadelphia, PA 19103, U.S.A.
Telephone: 215-988-0080
Telefax: 215-988-0739
Either party shall be entitled to change the domicilia citandi
executandi chosen by it by giving the other party thirty (30) days notice of
such change of address.
This is the last page of the Collaboration Agreement.
Exhibit 10.2
Material Evaluation Agreement
This Agreement is made by and between Hemispherx Biopharma, Inc. (hereinafter
referred to as "Hemispherx") and The Research Foundation for Microbial Diseases
of Osaka University (hereinafter referred to as "Biken").
RECITALS
WHEREAS, Hemispherx owns intellectual property rights relating to poly I: poly
C12U, with the trade name of Ampligen(R) and possesses proprietary rights and
know-how relating to the manufacture and production of Ampligen(R); and
WHEREAS, Biken is a manufacturer of biologicals in Japan, and has been engaged
for many years mainly in the research and development and manufacture of a
variety of infection-prophylactic vaccine products for human use. As part of the
work activities relating to a research project entitled "The Research Project on
Clinical Application of the Influenza Virus Vaccine in the Intranasal Dosage
Form for Mucosal Administration" (hereinafter referred to as the "Research
Project"), which is subsidized by the Japanese Ministry of Health, Labor and
Welfare (hereinafter referred to as the MHLW") and in which the National
Institute of Infectious Diseases of Japan (hereinafter referred to as the
"NIID") plays a main part and Biken also participates as one of the researchers
and during and in the course of which, at the end of each fiscal year research
results obtained thereby are to be compiled by the NIID into an annual research
report that will be submitted to the MHLW and subsequently place,,, for public
view, Biken has an intention to evaluate the functional capability of
Ampligen(R) in serving as an adjuvant to induce mucosal immune response. In
addition, Biken owns jointly with the NIID the intellectual property rights
relating to the "Novel Vaccine Containing Adjuvant Capable of Inducing Mucosal
Immunity", which is the object substance of the Research Project, and possesses
the technical know-how to prepare prototypes of such adjuvanted vaccine
preparation for experimental and research purposes.
NOW THEREFORE, in consideration of the mutual covenants and agreements made
herein, and for other good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the Parties agrees as follows:
1. OBJECTIVE
The objective of this Agreement is to set forth the terms and conditions under
which, as described in the Evaluation Program outlined in Exhibit 1 hereof,
Biken evaluates Ampligen(R) primarily from the aspects of both adjuvant-function
as induction of satisfactory mucosal immune response and its safety, in
collaboration with the Co-Researcher, by using the Prototype Vaccine Preparation
as defined in Paragraph (6) of Article 2 hereof (hereinafter referred to as the
"Evaluation"), in order to select candidates of both viral-antigens and
adjuvant-auxiliaries which are identified as the most promising substances and
determine the formulations of potential influenza virus vaccine candidates
containing such viral-antigens as the active ingredients and such
adjuvant-auxiliaries, during and in the course of the Research Project aimed at
practical use of a newly developed adjuvanted-influenza virus vaccine which is
capable of inducing a cross-protective immunity against seasonal influenza
viruses causing annual influenza epidemics and/or the new influenza viruses with
new pandemic potential.
2. DEFINITIONS
(1) "Ampligen(R)" shall mean poly I: poly C12U.
(2) "Confidential Information" shall mean and include all present and future
techniques, inventions, practices, enforcement, knowledge, know-how, skill,
experience, test data, analytical data, descriptions (including the
explanation set forth in Paragraph (3) of Article 6 hereof), and reports
(whether in electronic, documentary, eye readable or any other form)
generated or obtained by either Party or obtained through agreement with a
third party with regard to Ampligen(R) and/or the Evaluation to be
performed by Biken in cooperation with the Co-Researchers or disclosed by
either Party to the other Party pursuant to or in connection with this
Agreement, and identified as being confidential, and including any reports
prepared by either Party for the other, excluding, however, information
which:
1) is or comes into the public domain through no fault of the receiving
Party;
2) is known to the receiving Party prior to the date of disclosure, as
evidenced by written records of that Party; 3) is lawfully disclosed to
the receiving Party by a third party rightfully in possession of it; or
4) is independently and subsequently developed by an employee or agent
of the receiving Party who had no knowledge of the
Confidential Information disclosed under this Agreement or of any
Confidential Information derived by the receiving Party therefrom.
(3) "Effective Date" means the date on which this Agreement is last executed by
either Party.
(4) "Co-Researcher" means the following researchers, who are involved in the
Research Project as set forth in Recitals Clause hereof, who will cooperate
with Biken on the Evaluation:
------------------- ------------------------------------------------- ---------------------------------------
Name Institution/Organization to which one belongs Title
------------------- ------------------------------------------------- ---------------------------------------
------------------- ------------------------------------------------- ---------------------------------------
Hideki Hasegawa National Institute of Infectious Diseases Chief, Laboratory of Infectious
Diseases Pathology, Department of
Pathology
------------------- ------------------------------------------------- ---------------------------------------
------------------- ------------------------------------------------- ---------------------------------------
Masato Tashiro National Institute of Infectious Diseases
Director, Department of Virology III
------------------- ------------------------------------------------- ---------------------------------------
------------------- ------------------------------------------------- ---------------------------------------
Hiroshi Kida Department of Disease Control, Professor
Hokkaido University Graduate School of
Veterinary Medicine
------------------- ------------------------------------------------- ---------------------------------------
In case of any changes in personnel composition of the aforementioned
Co-Researcher, Biken shall so notify Hemispherx in writing.
(5) "Party" shall mean either Hemispherx or Biken or both, as the case may be.
(6) "Prototype Vaccine Preparation" shall mean the prototype of influenza virus
vaccine preparation in the form of intranasal and/or injectable dosage,
containing primarily of candidates of influenza viral-antigens and
Ampligen(R), which is prepared by Biken for the purpose of performing the
Evaluation as defined in Article 1 hereof.
(7) "Research Adviser" shall mean any of the following specialists, who
dispenses expert advice as required from Biken and/or the Co-Researcher in
a position of adviser on the Research Project during and in the course of
which Biken performs the Evaluation in cooperation with the Co-Researchers:
------------------------ ---------------------------------------------------- -----------------------
Name Institution/Organization to which one belongs Title
------------------------ ---------------------------------------------------- -----------------------
------------------------ ---------------------------------------------------- -----------------------
Koichi Yamanishi National Institute of Biomedical Innovation Director General
------------------------ ---------------------------------------------------- -----------------------
------------------------ ---------------------------------------------------- -----------------------
Takeshi Kurata Toyama Institute of Health Director
------------------------ ---------------------------------------------------- -----------------------
3. PROVISION OF MATERIAL AND RELATED INFORMATION
Provided that Biken agrees to the following terms, Hemispherx shall
provide Biken with Ampligen(R) and the Confidential Information relating
to Ampligen(R):
(1) During the effective term of this Agreement, Hemispherx grants to Biken the
exclusive right to use Ampligen(R) and the Confidential Information
relating to Ampligen(R) for the purpose of performing the Evaluation as
provided in Article 1 hereof in Japan.
(2) Biken shall use Ampligen(R) and the Confidential Information relating to
Ampligen(R) solely for the purpose of performing the Evaluation in
accordance with Paragraph (1) of this Article.
(3) Nothing contained herein shall be construed to grant to Biken any rights in
technology or license of any patent, copyright or trademark now or
hereafter in existence except for the purposes of the Evaluation.
4. SUPPLY OF AMPLIGEN(R) AND PAYMENT
(1) Hemispherx shall supply to Biken, pursuant to Biken's written request, and
Biken shall purchase from Hemispherx, such volume of Ampligen(R) as will be
necessary for Biken in performing the Evaluation in Japan. The price of
Ampligen(R) for such supply and purchase shall be as specified below:
..............................................................................
$200.00 U.S. per 400 mg. Unit
..............................................................................
(2) The payments of the price provided in Paragraph (1) of this Article shall
be made by Biken to Hemispherx within thirty (30) days after Biken's
receipt and inspection of the Ampligen(R) in the United States Dollars by
means of telegraphic transfer to the following bank account, unless
Hemispherx notifies otherwise to Biken in writing:
-------------------------- -----------------------------------------
Bank: Wachovia Bank
-------------------------- -----------------------------------------
-------------------------- -----------------------------------------
Bank Address: Centre Square Branch,
15th and Market Streets,
Philadelphia, PA 19102
Phone: (215) 985-7377
-------------------------- -----------------------------------------
-------------------------- -----------------------------------------
SWIFT No: International Swift Address: FUNB33 INT
-------------------------- -----------------------------------------
-------------------------- -----------------------------------------
Account Number: 2000-009-652305 ABA Number 031201468
-------------------------- -----------------------------------------
-------------------------- -----------------------------------------
Account Name: Hemispherx Biopharma, Inc.
-------------------------- -----------------------------------------
(3) If Biken detects that the Ampligen(R) provided by Hemispherx has any
defect, Biken shall notify Hemispherx of it, and Hemispherx shall recall
such defective items and provide non-defective Ampligen(R) at its cost
within thirty (30) days at the latest after the receipt of said notice from
Biken. In this case, the period of the payment set forth in the above
paragraph shall be thirty (30) days after Biken's receipt and inspection of
the replacement Ampligen.(R)
5. CONFIDENTIALITY
(1) Except as provided elsewhere herein, each Party shall keep in strict
confidence and shall not disclose to any third party any Confidential
Information (including the Ampligen(R) as owned by Hemispherx) provided or
disclosed by the other Party hereunder during the effective period hereof
without first obtaining the written consent of said other Party.
(2) Notwithstanding the provisions of the preceding Paragraph hereof, Biken may
disclose the Confidential Information (including the Ampligen(R) as owned
by Hemispherx) provided or disclosed by Hemispherx hereunder during the
effective period hereof to the Co-Researcher and/or the Research Adviser,
as defined in Paragraphs (4) and (7) of Article 2 of this Agreement,
respectively, provided both are then bound and agree to all provisions of
this Agreement relating to the confidentiality of Ampligen(R) and
Confidential Information.
(3) Each Party shall exercise the same degree of care and safeguards with
respect to the Confidential Information (including Ampligen(R) as owned by
Hemispherx) as used to maintain the confidentiality of its own information
of the similar nature; provided, however, the degree of the care and
safeguard shall not at any time be less than the reasonable degree.
(4) If Biken wishes to publish research papers relating to the use of
Ampligen(R) and the Confidential Information relating to Ampligen(R)
provided by Hemispherx pursuant to or in connection with this Agreement for
the purpose of the Evaluation, or to publicly disclose any information
relating to or resulting from such use, together with the Co-Researchers,
Biken shall notify Hemispherx in writing prior to the publication or
disclosure. As for the research results to be compiled into annual research
reports to be submitted to the MHLW and subsequently placed for public view
in connection with the Research Project referred to in the Recitals hereof,
it is deemed that by virtue of the execution of this Agreement by the
Parties hereto that Hemispherx has consented thereto.
(5) If either Party is required by any governmental agency, court or other
quasi-judicial or regulatory authorities to provide any of the Confidential
Information (including Ampligen(R) as owned by Hemispherx) provided or
disclosed by the other Party hereunder during the effective period hereof,
the Party shall, if possible, promptly notify the other Party in writing
prior to any such disclosure so that said other Party may seek an
appropriate remedy and/or waive compliance with the provisions of this
Agreement.
(6) The provisions in this Article shall remain in force for five (5) years
from the Effective Date notwithstanding termination or cancellation of this
Agreement; it being understood and agreed that the foregoing provisions of
this Article shall not be construed as permitting either Party to
voluntarily disclose any Confidential Information (including Ampligen(R) as
owned by Hemispherx) provided or disclosed by the other Party to it
hereunder during the effective period hereof to any third party subsequent
to the expiration of the aforesaid period of confidentiality.
6. EVALUATION AND TERM OF AGREEMENT
(1) Biken may, by giving prior written notice to Hemispherx, commission a part
of the evaluation tests which are necessitated by the Evaluation Program
outlined in Exhibit 1 hereof, to external specialized testing institutions;
provided, however, that in such a case, Biken shall require said external
specialized testing institutions be bound by and agree to all provision of
this Agreement relating to the confidentiality of Ampligen(R) and
Confidential Information.
(2) This Agreement shall come into force and effect on the Effective Date, and
shall continue to be in force and effect until the expiration of a one year
period from the Effective Date, provided that this Agreement shall be
terminated when any of the following events occurs, and provided further
that Biken may extend the term of this Agreement for a period not exceeding
three (3) months by so notifying Hemispherx in writing not later than
thirty (30) days before the expiration of the original term of this
Agreement, if none of the following events will have occurred:
(a) Completion of the Evaluation Program with the Evaluation Program's
designated success end points having been achieved; (b) Cessation of
funding of the Research Project by MHLW with no alternative source of such
funding identified within ninety (90) days of the cessation of funding
by MHLW; or
(c)Completion of the Evaluation Program with the Evaluation Program's
designated success end points not having been achieved...
(3) Upon termination of this Agreement based on the paragraph (b) and (c) of
the proviso of Clause (2) of this article, unless otherwise agreed, Biken
shall return to Hemispherx or destroy, as instructed by Hemispherx, all
documents and data, whatever the type or media thereof may be, concerning
Ampligen(R) and the Confidential Information relating to Ampligen(R)
provided and disclosed by Hemispherx to Biken pursuant to or in connection
with this Agreement.
(4) Upon termination of this Agreement pursuant to paragraph (b) or (c) of the
proviso of Clause (2) of this article, unless otherwise agreed, Hemispherx
shall return to Biken or destroy, as instructed by Biken, all documents and
data (except for the results of the Evaluation , whatever the type or media
thereof may be, concerning Ampligen(R) and the Confidential Information
relating to Ampligen(R) provided and disclosed by Biken to Hemispherx
pursuant to or in connection with this Agreement.
(5) Notwithstanding paragraphs (3) and (4) of this Article, subject to
compliance with this Agreement, each Party may keep one (1) copy or sample
of the Confidential Information for archival purposes.
7. PATENT INFRINGEMENT
In the event that a third party files claims or suits against either Party, to
whom the other Party has provided and/or disclosed its own Confidential
Information (including Ampligen(R) as owned by Hemispherx) pursuant to this
Agreement during the effective period hereof, on the basis of the alleged
infringement of any patent or other intellectual property right of said third
party in connection with such information, the disclosing Party shall, at its
sole cost and responsibility, deal with, dispose of and settle such claims or
suits brought by said third party and shall pay and bear any and all costs,
damages and liabilities incurred in connection therewith.
8. FORCE MAJEUR
(1) Force Majeur shall be deemed to have prevented, restricted or interfered
with the performance by a Party hereto of any of its obligations hereunder
if such event occurs by reason of flood, fire, explosion, strike, war,
revolution, civic commotions, political riot, acts of public enemies,
blockage or embargo or sanctions or any law, interdict, order proclamation,
regulation, ordinance, demand or requirements of any government.
(2) Neither Party shall be held responsible for damages caused by any delay or
default due to force majeur.
9. SUCCESSORS AND ASSIGNS@
This Agreement and all rights and obligations arising hereunder shall not be
assigned or otherwise transferred by either Party, whether by operation of law
or otherwise, unless the other Party has given its written consent thereto, and
any such purported assignment or transfer without such written consent shall be
null and void.
10. HEADINGS
The headings of the clauses of this Agreement have been inserted only to
facilitate reference and shall not be taken as being of any significance
whatsoever in the construction and interpretation of this Agreement.
11. GENERAL
(1) No waiver by either Party of a provision hereof or default hereunder shall
be deemed as a waiver of any other provisions or default.
(2) Any notices or communications to or from the respective Parties required or
permitted to be given hereunder shall be deemed to have been received:
1) if mailed by registered prepaid airmail to the recipient at the
address as set forth in Article 14 hereof and the date of receipt
shall be deemed to be fourteen (14) working days after date of
mailing unless the contrary can be proved;
2) if sent by telefax to the recipient at the number given herein and
evidence exists of receipt of thereof on the next business day of
the recipient after sending unless the contrary can be proved and
provided that such telefax message is confirmed by registered
prepaid post.
(3) This Agreement including the attached Exhibit hereto constitutes the entire
agreement between the Parties hereof with respect to the subject matter
hereof. This Agreement may only be changed or amended by writing executed
by the authorized representatives of the Parties which refers to this
Agreement and contains a copy thereof as an attached document.
(4) If any provision of this Agreement is found by any court of competent
jurisdiction to be invalid or unenforceable for any reason whatsoever, this
shall not in itself be deemed to affect the other provisions thereof and
such invalid or unenforceable clause shall be severable from the remaining
terms of this Agreement.
12 DRESOLUTION OF DISPUTE
(1) Any dispute at any time between the Parties hereto arising out of or
pursuant to this Agreement or its interpretation, rectification, breach or
termination shall, if not resolved through negotiations between the
Parties, be finally settled by arbitration. Arbitration shall be conducted
in the United States pursuant to the rules of the American Arbitration
Association in New York, New York, U.S.A. if Hemispherx is the respondent,
and in Tokyo, Japan pursuant to the Commercial Arbitration Rules of the
Japan Commercial Arbitration Association if BIKEN is the respondent.
(2) The decision of the arbitrator shall be final and binding and shall be
capable of being made an order of any court having jurisdiction over any of
the Parties.
(3) This Agreement shall be governed by and construed in accordance with the
laws of Japan.
13 DCOUNTERPARTS OF AGREEMENT
This Agreement is prepared and made in the English language in duplicate.
14 DOMICILIA
The Parties hereto choose domicilia citandi et executandi for all purposes in
terms of this Agreement as follows:
(1) Hemispherx Biopharma, Inc.
One Penn Center
1617 JFK Blvd.
Philadelphia, PA 19103
Telephone: 215-988-0080
Telefax : 215-988-0739
(2) The Research Foundation for
Microbial Diseases of Osaka University (Biken)
3-1, Yamada-Oka, Suita
Osaka, 565-0871, Japan
Telephone: +81-6-6877-4804
Telefax : +81-6-6876-1984
Either Party shall be entitled to change the domicilia citandi et executandi
chosen by it giving the other Party thirty (30) days notice of such change of
address.
IN WITNESS WHEROF, the Parties have caused this Agreement to be executed by
their duly authorized representatives as of the day and year set forth below.
HEMISPHERX BIOPHARMA, INC. THE RESEARCH FOUNDATION FOR
MICROBIAL DISEASES OF OSAKA UNIVERSITY
/s/ William A. Carter /s/ Yasushi Higashi
-------------------------- -------------------------------------------------
-------------------------- -------------------------------------------------
Represented by: Represented by:
Name: William A. Carter Name:: Yasushi Higashi, M.D., D.M.Sc.
Title: Chairman of the Board, Title: Chairman, Board of Directors
Chief Executive
Officer
Address: Address:
One Penn Center 3-1, Yamada-Oka, Suita,
1617 JFK Blvd. Osaka 565-0871
Philadelphia, PA 19103 JAPAN
Date: Dec. 13, 2007 Date: Dec. 12, 2007
Exhibit 1
Evaluation Program
The Outline of the Evaluation Program on the Ampligen(R) as a candidate for
Adjuvant incorporated into Potential Influenza Virus Vaccines in the form of
Intranasal Mucosal Administration
1.Evaluation of the Efficacy and Stability of Prototype Vaccines(one-year study)
Evaluate the immunogenicity of intranasal prototype vaccines containing
antigens from 3 sub-type influenza viruses, namely, H1N1, H3N2 and B.
(1) Evaluation of immunogenicity of prototype vaccines in mouse models
1) Step-1
Investigate the immunogenicity of prototype vaccines containing
different-concentrated antigens in combination with the
Ampligen(R) of varying concentration levels.
the needed volume of the Ampligen(R): around 140 mg
2) Step-2
Evaluate antigens prepared with different culture methods for selection
of candidate vaccine strain.
the needed volume of the Ampligen(R): around 100 mg
3) Step-3
Assess the efficacy of prototype vaccines on challenge experiment.
the needed volume of the Ampligen(R): around 100 mg
(2) Evaluation of immunogenicity of prototype vaccines in animal models other
than mice
the needed volume of the Ampligen(R): around 500 mg
(3) Evaluation of stability of prototype vaccines for formulation of
candidate vaccines (preliminary tests) the
needed volume of the Ampligen(R): around 750 mg
The total volume of Ampligen(R)as required for the above-mentioned Efficacy and
Stability Evaluation Studies: around 1600 mg
2. Evaluation of the Safety Profile of the Ampligen(R)(one-year study)
Perform the following testing items through procuring external GLP (Good
Laboratory Practice) study-related services from contract research
organizations:
(1) Single dose toxicity study (FD (fatal dose) in rat models)
the needed volume of the Ampligen(R): around 160 mg
(2) Single dose toxicity study (Setting test for probable maximum
repeat-dose in dog models)
the needed volume of the Ampligen(R): around 160 mg
(3) Repeated dose toxicity study (Toxicity study in rat models)
the needed volume of the Ampligen(R): around 5 mg
The total volume of Ampligen(R)as required for the above-mentioned Safety
Profile Evaluation Studies: around 325 mg