EXHIBIT 10.31


 


Portions Subject to
Confidential Treatment Request Under Rule 406


 


 


R&D
ALLIANCE AGREEMENT


 


 


BETWEEN


 


 


GANIAL
IMMUNOTHERAPEUTICS, INC.


 


(“GIT”)


 


 


AND


 


 


VIRAL
GENOMIX, INC.


 


(VGX)


 

















 


TABLE OF CONTENTS


 


	
   

  	
   

  	
  Page

  
	
   

  	
   

  	
   

  
	
  1.

  	
  DEFINITIONS

  	
  1

  
	
   

  	
   

  	
   

  
	
  2.

  	
  R&D GRANT

  	
  3

  
	
   

  	
   

  	
   

  
	
  3.

  	
  FEES AND ROYALTIES

  	
  3

  
	
   

  	
   

  	
   

  
	
  4.

  	
  CONFIDENTIALITY

  	
  5

  
	
   

  	
   

  	
   

  
	
  5.

  	
  TERM AND TERMINATION

  	
  6

  
	
   

  	
   

  	
   

  
	
  6.

  	
  REPRESENTATIONS AND WARRANTIES OF GIT; DISCLAIMER OF ADDITIONAL
  WARRANTIES; INDEMNIFICATION

  	
  8

  
	
   

  	
   

  	
   

  
	
  7.

  	
  USE OF GIT’S AND VGX’S
  NAME

  	
  10

  
	
   

  	
   

  	
   

  
	
  8.

  	
  ADDITIONAL PROVISIONS

  	
  10

  



 


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R&D
ALLIANCE AGREEMENT


 


This R&D Agreement (“AGREEMENT”) is between Viral Genomix, Inc.
(“VGX”), a Delaware corporation, with offices located at 450 Sentry Parkway
East, Blue Bell, Pennsylvania 19422, and GANIAL
IMMUNOTHERAPEUTICS, INC (“GIT”), a Delaware corporation, having a
place of business at 24 High Street, Locust Valley, NY 11560.


 


BACKGROUND


 


A. GIT controls certain intellectual property related
to GIT027 (3-phenyl-4,5-dihydro-5-isoxazoleacetic acid) (hereinafter referred
to as “GIT027”) as drugs for treating all and any disease indications in humans
and animals, not limited to listed in Attachment I;


 


B. VGX desires to obtain EXCLUSIVE, WORLDWIDE rights
to conduct research and development activities and to market GIT027 for all
indications;


 


C. GIT will also grant VGX future rights, but not an
obligation to attain additional derivative compounds/technology of GIT027 from
GIT on the same terms as those of GIT027.


 


NOW, THEREFORE, in consideration of the promises and covenants
contained in this AGREEMENT and intending to be legally bound, the parties
agree as follows:


 


1.             DEFINITIONS


 


1.1   AFFILIATE of VGX means any
legal entity directly or indirectly controlling, controlled by or under common
control with VGX that has executed (a) this AGREEMENT, or (b) a
written joinder agreement, in a form reasonably satisfactory to GIT, agreeing
to be bound by all of the terms and conditions of this AGREEMENT, as if such
AFFILIATE of VGX were an original party to this AGREEMENT.  For purposes of this AGREEMENT, “control”
means the direct or indirect ownership of more than fifty percent (50%) of the
outstanding voting securities of a legal entity, and/or the right to receive
more than fifty percent (50%) of the profits or earnings of a legal entity,
and/or the right to control the policy decisions of a legal entity.


 


1.2   AFFILIATE OF GIT means any
legal entity directly or indirectly controlling, controlled by or under the
common control with GIT that has executed (a) this AGREEMENT, or (b) a
written joinder agreement, in a form reasonably satisfactory to VGX, agreeing
to be bound by all of the terms and conditions of this AGREEMENT, as if such
AFFILIATE of GIT were an original party to this AGREEMENT.  For purposes of this AGREEMENT, “control”
means the direct or indirect ownership of more than fifty percent (50%) of the
outstanding voting securities of a legal entity, and/or the right to receive
more than fifty percent (50%) of the profits or earnings of a legal entity,
and/or the right to control the policy decisions of a legal entity.


 


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1.3   CALENDAR QUARTER means each
three-month period, or any portion thereof, beginning on January 1, April 1,
July 1 and October 1.


 


1.4   CALENDAR YEAR means each
12-month period beginning on January 1.


 


1.5   EFFECTIVE DATE means the date
on which VGX and GIT have both fully executed this AGREEMENT.


 


1.6   FAIR MARKET VALUE means the
cash consideration which VGX thereof would realize from an unaffiliated,
unrelated buyer in an arm’s length sale of an identical item sold in the same
quantity and at the same time and place of the transaction.


 


1.7   NET SALES is defined as the
gross amount of monies or cash equivalent or other consideration which is paid
by unrelated third parties to VGX for GIT027 by sale or other mode of transfer,
less all qualifying costs directly attributable to such sales, which are made,
made for, used or sold by VGX, its agents, employees and/or independent contractors.


 


NET SALES of a commercial
product comprising one or more GIT R&D PRODUCTS and one or more other
active ingredients (a “COMBINATION PRODUCT”) shall be calculated as set forth
above, subject to the provisions of Section 3.1.3.


 


1.8   GIT R&D PRODUCT(S) means
product(s) which is/are made, made for, used by, imported by or for, sold
by or offered for sale by VGX for each indication and/or any affiliate(s) of
VGX to unrelated third parties which (1) in the absence of this AGREEMENT
would infringe at least one claim of GIT PATENT RIGHTS described in patents
listed in Attachment I, or (2) use a process and/or machine covered by at
least one claim of GIT PATENT RIGHTS described in patents listed in Attachment
I.


 


1.9   PHASE III CLINICAL TRIALS means
a series of expanded controlled and uncontrolled, pivotal, multi-center
(generally) clinical studies, after adequate completion of preliminary efficacy
and dose-ranging studies, and after safety data has been established for a GIT
R&D PRODUCT, comprising patients with the disease or condition of interest,
to whom the GIT R&D PRODUCT is administered in order to obtain sufficient
efficacy and safety data (and better understand drug-related adverse effects)
to support regulatory submissions and labeling of the GIT R&D PRODUCT.


 


1.10 SALE means any bona fide
transaction for which consideration payment is received or expected for the
sale, use, lease, transfer or other disposition of GIT R&D PRODUCT(S) to
an unrelated third party.  A SALE of GIT
R&D PRODUCT (S) shall be deemed completed at the time VGX or its
affiliate receives payment for such GIT R&D PRODUCT (S).


 


1.11 GIT PATENT RIGHTS means all of
GIT’s interest in the rights represented by or issuing from (including all
claims referenced within) those patent applications listed in 


 


2

















 


ATTACHMENT I and
all future interests in such rights anywhere in the world of the GIT027
intellectual property.


 


2.             R&D GRANT


 


Subject
to the terms and conditions of this AGREEMENT, GIT grants to VGX for the term
of this AGREEMENT EXCLUSIVE WORLD-WIDE rights to research, develop and market
GIT R&D PRODUCTS. VGX has the rights to freely choose any and/or all of the
product types. No other rights are granted by either party hereunder.  This agreement shall not impair VGX’s freedom
(without any restriction or any obligation to GIT) to research, develop, and
market products that do not infringe GIT PATENT RIGHTS.


 


2.1   , GIT shall deliver GIT027
(3-phenyl-4,5-dihydro-5-isoxazoleacetic acid) (GIT027) necessary for the
production or intended for production of GIT R&D PRODUCTS upon VGX’s
request. GIT shall provide technical assistance/expertise to, share
pre-clinical testing data, and clinical results with VGX for product
development and clinical development. GIT shall also provide relevant
documentation, including the history and generation of GIT027, established
assay protocols, summary for pre-clinical testing procedures and results, and
to assist VGX’s regulatory filing.   GIT
will provide technical assistance and expertise related to the production and
development of GIT027 at a mutually agreed timeline.


 


3.             FEES AND ROYALTIES


 


3.1   Fees and Royalties .


 


3.1.1        VGX shall
pay to GIT within thirty days (30) days of the EFFECTIVE DATE a payment of ****** in cash, certified funds, or by wire transfer.


 


3.1.2        VGX shall
pay GIT an additional ******  issuing
******  of VGX common stock (par value $.0001 per
share) to GIT or its assignees within thirty (30) days of the EFFECTIVE DATE.


 


3.1.3        Within first
5 years from the Effective Date, VGX also agrees to provide an amount equal to
******  of total funds from EACH funded
government grant directly received by VGX involving research and development of
GIT027.  The amount provided to GIT per
EACH funded grant shall not exceed a total of ******.


 


3.1.4        In further
consideration of the exclusive worldwide R&D granted to VGX, VGX shall pay
to GIT, on a quarterly basis, a royalty of ******  of
the NET SALES of each GIT R&D PRODUCT, which is sold by VGX and any
affiliate(s), agent(s), and/or independent contractor(s) of VGX. Such
royalty payments shall terminate on a product-by-product basis upon the date,
which is ten (10) years after the date of the first SALE of such GIT
R&D PRODUCT but not to exceed the date when effective patent protection on
individual product is lost in each respective country.


 


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3.1.5        In the event
one or more GIT R&D PRODUCTS are sold in a COMBINATION PRODUCT, the amount
of royalties and affiliate(s) revenues paid to GIT pursuant to this Section 3.1
shall be based on the portion of the FAIR MARKET VALUE of such combination of
products reasonably attributable to the GIT R&D PRODUCT(S).


 


3.2   Diligence and Milestone Fees.


 


3.2.1        VGX shall
use commercially reasonable efforts to develop for SALE and to market GIT
R&D PRODUCTS as drugs for treating all and any disease indications in
humans and animals.


 


3.2.2        The
following R&D milestone payments are payable by VGX to GIT within sixty
(60) days after the achievement of the respective milestone event:


 


	
  Due Date

  	
   

  	
  Payment

  
	
  Upon completion of patient accrual for the initial
  Phase II clinical trial for GIT027 in the United States for the FIRST disease
  indication

  	
   

  	
  $

  	
  50,000

  
	
  Upon completion of patient accrual for Phase III
  clinical trial for GIT027 in the United States for the FIRST disease
  indication

  	
   

  	
  $

  	
  250,000

  
	
  Upon NDA approval for GIT027 for EACH disease
  indication

  	
   

  	
  $

  	
  2,000,000

  



 


3.3   Option to Purchase Rights.


 


3.3.1        Within first
7 years from the Effective Date, VGX shall have the option to purchase all of
GIT’s worldwide rights to GIT027 for ******. VGX shall provide thirty (30) days
written notice of its intention to purchase such rights any time during the
first ******  years. The
payment for worldwide rights for GIT027 shall be made forty five (45) days
after VGX notifies GIT of its intention to purchase such rights and no further
payment of any kind, including but not limited to any royalty payments,
milestone payments, etc. under this Agreement shall be due to GIT upon
completion of such purchase. In addition, if VGX or its Affiliates fails 


 


4

















 


to
lead GIT027 to Phase I Human Clinical trial study in the United States within
five (5) years from the effective date, VGX will return the rights to
develop GIT027 back to GIT. In such case, all further obligations of VGX to GIT
will be terminated.


 


3.4   Currency, Payment Method.


 


3.4.1        All dollar
amounts referred to in this AGREEMENT are United States dollars.  All payments to GIT under this AGREEMENT
shall be made in United States dollars by check or wire-transfer.  If VGX receives revenues from SALES of GIT
R&D PRODUCTS in currency other than United States dollars, revenues shall
be converted into United States dollars at the conversion rate for the foreign
currency as published in the eastern edition of The Wall Street Journal as of
the last business day of the applicable CALENDAR QUARTER.


 


4.             CONFIDENTIALITY


 


4.1   CONFIDENTIAL INFORMATION means
and includes all technical and business information, plans, inventions,
developments, discoveries, improvements, software, know-how, procedures,
methods, techniques, formulae, data, processes, studies, and other proprietary
ideas, whether or not patentable or copyrightable, that a party hereto
identifies as confidential or proprietary at the time it is delivered or
communicated to the other party hereto, or any other information that should
reasonably be recognizable by its nature to be confidential or trade secret
information of a party (including, without limitation, information respecting
such party’s business plans, sales and sales methods, customers and prospective
customers). CONFIDENTIAL INFORMATION should be in writing and marked
confidential or, if oral, should be reduced to writing within thirty (30) days
of disclosure and marked confidential.


 


4.2   Each party shall maintain in
confidence and not disclose to any third party any CONFIDENTIAL INFORMATION of
the other party during the term of this Agreement and for five (5) years
after the date of termination of this Agreement.  Each party shall ensure that its employees
have access to CONFIDENTIAL INFORMATION of the other party only on a
need-to-know basis, and are obligated to abide by such party’s obligations
under this Agreement.  The foregoing
obligation shall not apply to:


 


4.2.1        information
that is known to the receiving party prior to the time of disclosure, and was
not received directly or indirectly from the disclosing party hereunder in
violation of a confidentiality obligation, unless independently developed by or
for the receiving party, without exposure to or benefit of the disclosing party’s
CONFIDENTIAL INFORMATION, in each case, to the extent evidenced by written
records;


 


4.2.2        information
disclosed to the receiving party, without restriction, by a third party that
has a right to make such disclosure;


 


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4.2.3        information
that was or becomes patented, published or otherwise part of the public domain
as a result of acts by the disclosing party or a third person developing or
obtaining such information as a matter of right; and


 


4.2.4        information,
which the disclosing party permits, in writing, the receiving party to publicly
disclose.


 


If a receiving
party is required to disclose any of the disclosing party’s CONFIDENTIAL
INFORMATION by order of a governmental authority or a court of competent
jurisdiction; the receiving party shall timely inform its disclosing party,
reasonably cooperate at the disclosing parties expense with any reasonable
action the disclosing party takes to attempt to obtain confidential treatment
of such information by the authority or court, and limit its disclosure of such
information to the extent practical.


 


Note: Confidential
information shall not be disclosed to third party and this rule shall
apply to both VGX and GIT. This is particularly true for process development
data.


 


5.             TERM AND TERMINATION


 


5.1   This AGREEMENT, unless sooner
terminated as provided in this AGREEMENT, shall terminate upon the earlier of: (a) expiration
of the last-to-expire or become abandoned of the GIT PATENT RIGHTS in United
States; or (b) twenty (20) years after the EFFECTIVE DATE.


 


5.2   VGX may terminate this
Agreement (a) upon thirty (30) days written notice to GIT, if the sale or
other exploitation of the GIT R&D PRODUCT(s) becomes technologically
or commercially unfeasible; or (b) upon thirty (30)-days written notice to
GIT, and by doing all of the following:


 


5.2.1                        ceasing to
make, have made, use, import, sell and offer for sale all GIT R&D PRODUCTS;
and


 


5.2.2        paying all
monies owed to GIT up to the date of the termination excluding any future
obligation under this AGREEMENT.


 


5.3   GIT may terminate this
AGREEMENT, upon thirty (30)-days written notice to VGX, if any of the following
events of default (“Default”) occur:


 


5.3.1        VGX is more
than sixty (60) days late in paying to GIT royalties, expenses or any other
monies due under this AGREEMENT and VGX does not immediately pay GIT in full
any amounts due upon demand; or


 


5.3.2        VGX
experiences a Trigger Event (defined below);


 


5.3.3        VGX
materially breaches this AGREEMENT and does not cure the material breach within
sixty (60) days after the receipt of the written notice of such breach.


 


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5.4   “Trigger Event” means any of
the following:


 


5.4.1        If VGX:


 


5.4.1.1             becomes
insolvent, bankrupt or generally fails to pay its material debts as such debts
become due;


 


5.4.1.2             is
adjudicated insolvent or bankrupt; admits in writing its inability to pay its
debts; or shall suffer a custodian, receiver or trustee for it or substantially
all of its property to be appointed and, if appointed without its consent, is
not discharged within thirty (30) days of such appointment; or


 


5.4.1.3             makes an
assignment for the benefit of creditors; or suffers proceedings under any law
related to bankruptcy, insolvency, liquidation or the reorganization,
readjustment or the release of debtors to be instituted against it and, if
contested by it, not dismissed or stayed within thirty (30) days;


 


5.4.2        If
proceedings under any International law related to bankruptcy, insolvency,
liquidation, or the reorganization, readjustment or the release of debtors are
instituted or commenced by VGX;


 


5.4.3        If any order
for relief is entered relating to any of the proceedings described in Sections
5.4.2 ;


 


5.4.4        If VGX shall
call a meeting of its creditors with a view to arranging a composition or
adjustment of its debts; or


 


5.4.5        If VGX
shall, by any act or failure to act, indicate its consent to, approval of or
acquiescence in any of the proceedings described in Sections 5.4.2, 5.4.3,
5.4.4.


 


5.5   The provisions of Sections 5.3
and 5.4 shall apply to a Default of, or a Trigger Event experienced by, any
affiliate(s) of VGX’s rights hereunder if and to the extent that such
Default of, or Trigger Event experienced by, the affiliate(s) causes VGX
to fail to meet its diligence obligations under Section 3.2.


 


5.6   In the event of a termination
under Section 5.1 or 5.3, all duties of GIT (other than under Sections
5.11) and all rights (but not duties) of VGX (other than under Section 5.11)
under this AGREEMENT immediately terminate without the necessity of any action
being taken either by GIT or by VGX, provided, however, that in no event shall
the foregoing be construed to obligate VGX to pay any amounts accruing under
Sections 3.1  after the date of
termination except under Section 5.10. 
Upon and after any termination of this AGREEMENT, the rights covered by
this agreement for VGX and any affiliate thereof to manufacture, sale,
marketing, importation and/or distribution of GIT 


 


7

















 


R&DPRODUCT(s) shall
terminate on the same date of the termination of the agreement, except
otherwise specified in this agreement or agreed upon by both parties.


 


5.7   Upon termination of this
AGREEMENT, each (receiving) party shall, at the other (disclosing) party’s
request, return to the other party all CONFIDENTIAL INFORMATION (except for one
copy for archival purposes) of the other party provided hereunder.


 


5.8   Upon termination of this
AGREEMENT under section 5.2 and 5.3, VGX shall cause physical inventories to be
taken as soon as commercially practicable and in any event no later than sixty
(60) days after termination of: (a) all completed GIT R&D PRODUCT(s) on
hand, under the control of VGX or affiliate(s) thereof; and (b) such GIT
R&D PRODUCT(s) as are in the process of manufacture and component
parts thereof as of the date of termination of this AGREEMENT, which
inventories shall be reduced to writing. 
VGX shall deliver copies of such written inventories, verified by an
officer of VGX, forthwith to GIT.  GIT
shall have forty five (45) days after receipt of such verified inventories
within which to challenge the inventory and request an audit thereof.


 


5.9   Upon termination of this
agreement under section 5.1, VGX shall pay all monies owe to GIT up to the date
of the termination.


 


5.10 Notwithstanding the foregoing, if
this AGREEMENT terminates other than pursuant to Section 5.3.1 or 5.3.2,
VGX shall have a period of six (6) months to sell off its inventory of GIT
R&D PRODUCT(s) existing on the date of termination of this AGREEMENT
and shall pay royalties to GIT with respect to such GIT R&D PRODUCT(s) within
thirty (30) days following the expiration of such six-month period.


 


5.11 Each party’s obligation to pay
all monies owed and accruing as of the date of termination under this AGREEMENT
shall survive termination of this AGREEMENT. 
In addition, the provisions of Articles 4, 5, 6, 7 and 8 shall survive
such termination.


 


6.                                       REPRESENTATIONS
AND WARRANTIES OF GIT AND VGX; DISCLAIMER OF ADDITIONAL WARRANTIES;
INDEMNIFICATION


 


6.1   GIT represents and warrants to
VGX that:


 


6.1.1        GIT has the
full authority to execute and deliver this AGREEMENT.


 


6.1.2        No material
claim by any third party contesting the validity, enforceability,
collaborations, use or ownership of any of such GIT PATENT RIGHTS has been
made, is currently outstanding or is threatened against GIT.


 


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6.2   GIT and VGX will work together
to file the patents and/or patent applications listed in ATTACHMENT I before
the deadline permitted by the international and US patent laws.


 


6.3   GIT shall defend and indemnify
and hold VGX (and its Affiliates, and their respective officers, directors and
employees) harmless against any and all Losses, arising out of, relating to,
based on, or caused by (A) the breach by GIT of any representation or
warranty contained in this Agreement, (B) a claim that the formulation or
manufacture of the GIT027 by GIT for VGX or other activities of GIT under this
Agreement infringe on the patent or other intellectual property rights of a
third party, (C) any governmental or regulatory action arising out of GIT,
or (D) any negligence or intentional misconduct by GIT in connection with
performing its obligations under this Agreement, in each case except to the
extent that such Losses arise from or are aggravated in any substantial respect
by the negligent acts of or failure to act by VGX or its Affiliates.  VGX will promptly notify GIT of any such
Losses which come to VGX’s attention, but failure to do so will not relieve GIT
of its indemnification obligations under this Section 6.3 except to the
extent any such delay results in a material prejudice to GIT.  Notwithstanding anything to the contrary in
this Agreement, GIT shall not be liable for any Losses to the extent that the
Losses suffered by VGX (and its Affiliates, and their respective officers,
directors and employees) are the result of or in consequence of any failure by
the indemnified party to take reasonable and prudent action to mitigate any
Losses.


 


6.4   VGX shall defend and indemnify
and hold GIT (and its Affiliates, and their respective officers, directors and
employees) harmless against any Losses, arising out of, relating to, based on,
or caused by (A) the breach by VGX of any representation or warranty
contained in this Agreement or (B) any negligence or intentional
misconduct by VGX in connection with performing its obligations under this
Agreement, in each case except to the extent that such Losses arise from or are
aggravated by the negligent acts of or failure to act by GIT or its Affiliates.  GIT will promptly notify VGX of any such
Losses which come to GIT’s attention, but failure to do so will not relieve VGX
of its indemnification obligations under this Section 6.4 except to the
extent any such delay results in a material prejudice to VGX.  Notwithstanding anything to the contrary in
this Agreement, VGX shall not be liable for any Losses where the Losses
suffered by GIT (and its Affiliates, and their respective officers, directors
and employees) are the result of or in consequence of any failure by the
indemnified party to take reasonable and prudent action to mitigate any Losses.


 


6.5   There are no pending or
threatened suits, claims, or actions of any type whatsoever against GIT with
respect to the GIT027.


 


6.6   All necessary corporate
authorizations, consents and approvals which are necessary or required for GIT
to enter into this Agreement have been duly obtained;


 


6.7   To the best of its knowledge,
the entering into of this Agreement by GIT will not (i) violate any
Applicable Law or(ii) conflict with or result in any breach of any of the
terms, conditions or provisions of, or constitute a default (or give rise to
any right of termination,


 


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cancellation or
acceleration) under, or result in the creation of any lien, security interest,
charge or encumbrance upon any of the properties or assets of GIT, under its
organizational documents, as amended to date, or any material note, indenture,
mortgage, lease, agreement, contract, purchase order or
other instrument, document or agreement to which GIT is a party or by which it
or any of its properties or assets is bound or affected.


 


7.           USE
OF GIT’S AND VGX’S NAME


 


7.1   VGX and its employees and agents shall not
use and VGX shall not permit its affiliate(s) to use GIT’s name or any
adaptation thereof, or any GIT seal, logotype, trademark, or service mark, or
the name, mark, or logotype of any GIT representative or organization in any
way without the prior written consent of GIT. However, GIT shall not
unreasonably withhold such written consent.


 


7.2   GIT and its employees and agents shall not
use and GIT shall not permit its affiliate(s) to use the VGX’s name or any
adaptation thereof, or any VGX seal, logotype, trademark, or service mark, or
the name, mark, or logotype of any VGX representative or organization in any
way without the prior written consent of the VGX. However, VGX shall not
unreasonably withhold such written consent.


 


8.           ADDITIONAL
PROVISIONS


 


8.1   Nothing in this AGREEMENT shall be deemed to
establish a relationship of principal and agent between GIT and VGX, or between
or among any of either party’s agents or employees for any purpose whatsoever,
nor shall this AGREEMENT be construed as creating any other form of legal
association or arrangement which would impose liability upon one party for the
act or failure to act of the other party.


 


8.2   From EFFECTIVE DATE, VGX will pay all fees
charged by the patent office (including application fees and maintenance fees
for patents listed in Attachment I and future patents selected by VGX according to section 3.1.4)
and by patent application agencies (including translation fees, agency fees,
and lawyer fees for patents
listed in Attachment I and future
patents selected by VGX according to section 3.1.4) if these expenses
incurred after the effective date of the agreement. VGX shall control,
prosecute and maintain the patent rights related to this AGREEMENT.


 


8.3   VGX is permitted to assign this AGREEMENT or
any part of it to any person or entity, either directly or by operation of law,
without the prior written consent of GIT in its sole discretion.  VGX has the rights to contract out the
manufacturing of the products covered in this agreement and rights to establish
collaboration, development, and marketing partnership with a third party. In
case any products covered in this agreement is sold by a marketing partnership,
VGX shall have the responsibility to pay royalty that is calculated on the
bases of the combined net sales of VGX and its marketing partners. No
assignment relieves VGX of responsibility for the performance of any accrued
obligations, which it has prior to such assignment.


 


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8.4   A waiver by either party of a breach of any
provision of this AGREEMENT will not constitute a waiver of any subsequent
breach of that provision or a waiver of any breach of any other provision of
this AGREEMENT.


 


8.5   Notices, payments, statements, reports and other
communications under this AGREEMENT shall be in writing and shall be deemed to
have been received as of the day after the date sent if sent by public courier
(e.g., Federal Express) or by Express Mail, receipt requested, and addressed as
follows:


 


If for VGX:


 


Viral Genomix, Inc.


VGX
Pharmaceuticals


450 Sentry Parkway
East


Blue Bell, PA
19422


Attention: Chief
Executive Officer


 


If for GIT:


 


Ganial
Immunotherapeutics, Inc.


24 High Street


Locust Valley, NY
11560


Attention: Chief
Executive Officer


 


Either party may
change its official address upon written notice to the other party.


 


8.6   This AGREEMENT shall be construed and
governed in accordance with the laws of the Commonwealth of Pennsylvania,
without giving effect to conflict of law provisions.  In the event that a party to this AGREEMENT
perceives the existence of a dispute with the other party concerning any right
or duty provided for herein, the parties will, as soon as practicable, confer
in an attempt to resolve the dispute.  If
the parties are unable to resolve such dispute amicably, then the parties
hereby submit to the exclusive jurisdiction of and venue in the courts located
in the Eastern District of the Commonwealth of Pennsylvania with respect to any
and all disputes concerning the subject of this AGREEMENT.


 


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8.7   VGX shall comply with all prevailing laws, rules and
regulations that apply to its activities or obligations under this
AGREEMENT.  Without limiting the
foregoing, it is understood that this AGREEMENT may be subject to United States
laws and regulations controlling the export of technical data, computer
software, laboratory prototypes and other commodities, articles and
information, including the Arms Export Control Act as amended in the Export
Administration Act of 1979, and that the parties’ obligations are contingent
upon compliance with applicable United States export laws and regulations.


 


8.8   If any provision of this AGREEMENT shall be
held to be illegal, invalid or unenforceable, then such illegality, invalidity
or unenforceability shall attach only to such provision, and shall not in any
manner affect or render illegal, invalid or unenforceable any other provision
of this AGREEMENT, and this AGREEMENT shall be carried out as if any such
illegal, invalid or unenforceable provision were not contained herein.


 


8.9   This AGREEMENT may not be changed, modified,
extended or terminated except by written amendment executed by an authorized
representative of each party.


 


[SIGNATURE PAGE FOLLOWS]


 


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IN WITNESS WHEREOF, the parties, intending to be legally bound, have
caused this AGREEMENT to be executed by their duly-authorized representatives.


 


 


	
  GANIAL IMMUNOTHERAPEUTICS, INC.

  	
  VIRAL GENOMIX, INC.

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
        /s/ Ferdinando
  Nicoletti

  	
   

  	
  By:

  	
         /s/ J.
  Joseph Kim

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
   Dr. Ferdinando Nicoletti

  	
   

  	
  Name:

  	
  J. Joseph Kim, Ph.D.

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
      President and CEO

  	
   

  	
  Title:

  	
        President and
  CEO

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
     December 19,2005

  	
   

  	
  Date:

  	
      December 19, 2005

  
												



 


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