EXHIBIT
10.33


 


Portions Subject
to Confidential Treatment Request Under Rule 406


 


Pfenex Expression
TechnologyTM


 


COMMERCIAL LICENSE AGREEMENT


 


This Agreement is effective
as of the latest date of signing below and is by and between Dow Global Technologies
Incorporated (“Dow”), a Delaware corporation having its principal offices at
2030 Dow Center, Midland, MI, 48674 USA and VGX Pharmaceuticals, Inc, a Delaware
corporation (“VGX”) having a principal place of business at 450 Sentry Parkway,
Blue Bell, PA 19422.


 


VGX further desires to secure a non-exclusive license to Dow’s Pfenex Expression TechnologyTM for the clinical and commercial
production of Product.


 


Accordingly, in
consideration of the premises and the mutual covenants of this Agreement, the
parties hereto agree as follows:


 


Article 1                DEFINITIONS


 


1.01         Affiliates:  “Affiliates” shall mean any entity that, directly
or indirectly through one or more intermediates, controls, is controlled by or
is under common control with either VGX or Dow, where “controls”, “controlled
by”, and “is under common control” means ownership, directly or indirectly, of
fifty percent (50%) or more of the voting equity interest in the entity or the
possession, direct or indirect, of the power to direct or cause the direction
of the management and policies of that entity, whether through ownership or
voting securities, by contract or otherwise.


 


1.02         Biological Material:  “Biological Material” shall mean Dow proprietary
strains of transformed Pseudomonas fluorescens
genetically engineered to express Product. 
It includes Dow proprietary strains of Pseudomonas
fluorescens, Dow proprietary plasmids and expression vectors for
transforming Pseudomonas fluorescens, Dow
proprietary nucleic acid and protein based probes relating to genetic
transformation of Pseudomonas fluorescens, and Dow
proprietary plasmids and expression vectors for transforming Pseudomonas fluorescens to express Product, and Dow proprietary
nucleic acid and protein based probes relating to genetic transformation of Pseudomonas fluorescens that express Product.


 


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1.03         Calendar Year:  “Calendar Year” shall mean January 1st and ending December 31st.


 


1.04         Calendar Quarter:  “Calendar Quarter” shall mean a three month period
ending March 31, June 30, September 30 or December 31.


 


1.05         Commercially Reasonable Efforts:  “Commercially Reasonable Efforts” shall mean,
with respect to the development, manufacture, or commercialization of a
Product, that level of effort and resources customarily applied in the research-based
biopharmaceutical industry to a product of similar commercial potential at a
similar stage in its lifecycle, taking into consideration its safety and efficacy,
cost to develop, the competitiveness of alternative products, its proprietary
position, likelihood of regulatory approval, profitability and all other relevant
factors.


 


1.06         Confidential Information:  “Confidential Information” shall mean any and
all proprietary information including know-how, data, intellectual property,
trade secrets, and other physical materials, and information (including without
limitation, information related to technical, business, including customer names,
information or addresses, and intellectual property matters), including
information contained in Royalty Reports, Status Reports, Termination Royalty Report,
Biological Material, Patent Rights, Know-How Technology, Product, information
and know-how related to the Product owned or held by either party to this Agreement,
now and in the future which is disclosed by either party to the other party in
connection with this Agreement.  The
Confidential Information shall include proprietary information disclosed in
writing or other tangible form, including samples of materials.  If Confidential Information is disclosed
orally, the Confidential Information shall be summarized in written form within
thirty (30) days by the disclosing party and a copy provided to the recipient.


 


1.07         Contract Manufacturer:  “Contract Manufacturer” shall mean anyone under
an agreement with VGX for the manufacture of Product.


 


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1.08         Effective Date:  “Effective Date” shall mean the last date of execution
of this Agreement.


 


1.09         Field: “Field” shall mean
production, clinical and commercial activities related to Product as it relates
to human therapeutic use.


 


1.10         Foreign Regulatory Authority:  “Foreign Regulatory Authority” means any applicable regulatory agency, or other governmental entity or authority of any country or regulatory jurisdiction having responsibility in such country or regulatory jurisdiction for any regulatory approvals of any kind necessary for the development, pre-clinical and/or human clinical testing, manufacture, supply, marketing and/or sale of Product in such country or regulatory jurisdiction.  Such approvals include, but are not limited to, a new drug study or clinical license certificate under the Special Access Programme (SAP), the Medicines and Healthcare products Regulatory Agency, or the Federal Institute for Drugs and Medical Devices.
 


1.11         Improvements:  “Improvements” shall mean all discoveries
and/or inventions (whether patented or not) made during the term of this Agreement
by VGX which constitute (i) a modification of Biological Material; (ii) a
modification of Know-How Technology; or (iii) which, if practiced, would
infringe any of the claims of Patent Rights or which relate directly or indirectly
to the Pfenex Expression TechnologyTM.  Made as used herein means the discovery or
invention was conceived or reduced to practice.   Improvements do not include any inventions
or discoveries related to Product alone.


 


1.12         Improvement Report:  “Improvement Report” shall mean a written report
that provides sufficient information so that Dow may practice such Improvement
and if necessary such report shall also include the transfer of material necessary
to practice Improvements.  Such report
will be made January 31st of each year.


 


1.13         Know-How Technology:  “Know-How Technology” shall mean Dow’s technical



 


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information and materials,
including without limitation, technology, data, bacterial strains, genetic
constructs, computer software and algorithms for controlling fermentation vessels
and related equipment, chemicals, inventions (patentable or otherwise), practices,
methods, knowledge, know-how, skill, and experience related directly or indirectly
to the Biological Material.


 


1.14         Licensed Territory:  “Licensed Territory” shall mean worldwide.


 


1.15         Net Sales:  “Net Sales” shall mean ******.


 


“Net sales” shall not
include any consideration received with respect to a sale, use or other
disposition of any Product as part of a clinical trial prior to the receipt of
applicable Regulatory Approval for the Product.


 


Sales of a Product to an
Affiliate or VGX Partner shall be excluded from Net Sales calculations, it being
understood and agreed that sales of a Product by such Persons shall be included
in Net Sales, as provided above.


 


******.


 


1.16         Parties:  “Parties” shall mean collectively Dow and
VGX.


 


1.17         Party:  “Party” shall mean either Dow or VGX as the
case may be.


 


1.18         Patent Rights:  “Patent Rights” shall mean Dow owned or
controlled patent
applications U.S. Application No. 10/590,095, 10/590,185, 10/994,138,
10/996,007, 11/400,840, 11/189,375 and U.S. Provisional Application titled “Codon
Optimization Method” and  any
divisional, continuation, foreign equivalent, substitute, renewal, extension, reissue,
reexamination, patents of addition, supplemental protection certificate, or
application therefore or patent issuing therefrom.


 


1.19         Pfenex Expression
TechnologyTM:  “Pfenex
Expression TechnologyTM” shall mean Patent Rights and Know-How Technology related
to or using directly or indirectly the Biological Material.


 


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1.20         Product:  “Product” shall mean the Vpr protein produced by the
Production Strain as defined in the IND filing that shall be provided to DOW by
VGX within ten (10) business days of the IND filing, expressed utilizing
DOW’s proprietary Pfenex Expression TechnologyTM,
DOW Know-How Technology and/or the Production Strain. For the avoidance of
doubt this Commercial License shall be for a single product. The amino acid sequence
of the Product is defined in Appendix B of this Agreement.


 


1.21         Production Strain:  “Production
Strain” shall mean a codon optimized Pseudomonas fluorescens
strain that is derived from the Pfenex Expression TechnologyTM provided by Dow to
VGX pursuant to this Agreement including VGX’s gene encoding for the Vpr protein
and is the strain designated CS469-002 (cytoplasmic) created as part of the Services
under the Letter Agreement between VGX and DOW with an effective date of February 9,
2006. Additionally, the five (5) other strains designated CS469-001,
CS469-003, CS469-007, CS469-008, CS469-009 and developed under the services performed
as part of the Letter Agreement between VGX and DOW (dated February 9,
2006) are also included under “Production Strain”.  The nucleotide sequences of each Production
Strain are listed in Appendix C of this Agreement.


 


1.22         Royalty Report:  “Royalty Report” shall mean the written report
due under this Agreement that report Royalties due under the Agreement.  The Royalty Report is due at the end of each
Calendar Quarter.


 


1.23         Termination Royalty Report:  “Termination Royalty Report” shall mean the
Royalty Report that is due after termination of this Agreement.


 


1.24         Third Party:  “Third Party” shall mean any person,
organization, firm, corporation, partnership or entity other than Dow, VGX and
their respective Affiliates.


 


1.25         VGX Partner:  “VGX Partner” shall mean anyone under an agreement
with VGX relating to the development, marketing, promotion or distribution of
Product.


 


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Article 2                                               LICENSE
GRANT AND TRANSFER OF BIOLOGICAL MATERIAL


 


2.01         Grant to VGX:


 


(a)          Dow
hereby grants to VGX and its Affiliates a non-exclusive, non-sublicensable,
royalty-bearing license under the Patent Rights and Know-How Technology to use
said Pfenex Expression TechnologyTM to make,
have-made, use and sell Product for clinical and commercial use. In the exercise
of its have-made rights under this section, VGX shall obtain Dow’s prior consent
to VGX’s selection of a Contract Manufacturer, such consent not to be unreasonably
withheld, delayed, or conditioned.  For
the avoidance of doubt, it is understood that the purpose of requiring Dow’s
consent is to provide reasonable assurance to Dow that the proposed Contract
Manufacturer or VGX Partner is subject to enforceable agreements imposing the
same confidentiality and limited use obligations with respect to Dow’s Confidential
Information and the Pfenex Expression
TechnologyTM as are undertaken by VGX under this Agreement, that the proposed
Contract Manufacturer or VGX Partner is located in a country or countries subject
to the rule of law and having functioning judicial systems for the enforcement,
if necessary, of such obligations, and such parties agree in writing to be
bound by terms and conditions at least as restrictive as those contained in
this Agreement.  VGX, VGX Partner, and/or
Contract Manufacturer shall not use any Biological Materials or Know-How Technology
for research or production that is not specifically related to Product.   VGX shall not have any right to sublicense
or transfer its rights under this Agreement. 
Except for production of Product using the Pfenex
Expression TechnologyTM, VGX shall not use any Biological Materials or Know-How
Technology for research or production.


 


(b)         Dow
hereby grants to VGX and its Affiliates an exclusive, non-sublicensable,
royalty-bearing license under the Patent Rights and Know-How Technology to the Pfenex Expression TechnologyTM to use the Production Strain
to make and/or have made Product. In the exercise of its have-made rights under
this section, VGX shall obtain Dow’s prior consent to VGX’s selection of a
Contract Manufacturer, such consent not to be unreasonably withheld, 


 


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delayed, or
conditioned.


 


2.02         Notwithstanding the foregoing, VGX reserves the right to sublicense the Product to a Third Party.  Licensee shall assure the performance of the confidentiality and limited use obligations
by its Contract Manufacturer or Licensee Partner and any such agreement shall include terms and conditions at least
as restrictive as the terms and conditions in this Agreement.


 


2.03         Transfer of Biological Material and
Technical Support:  Upon execution of
this Agreement, Dow shall transfer Biological Material and the Know-How Technology
package to VGX and the Know-How Technology package will be added as Appendix
A.  Dow shall provide commercially reasonable
technical assistance to VGX in the use of Biological Material and Know-How Technology
at Dow’s prevailing hourly rate at the time technical assistance is provided.


 


2.04         Parties’ Roles:  VGX shall have complete control of purchasing
and the detailed design, construction and operation (including maintenance) of the equipment necessary to
produce Product using Pfenex Expression TechnologyTM.  Dow’s role is a technical advisor.  Among other things, this means that VGX is
solely responsible for all of the following: 
(i) safety, (ii) the selection, retention, supervision, performance,
and payment of qualified engineer(s), constructor(s) and/or contractor(s),
(iii) the detailed design, and the construction, operation and maintenance
of the equipment necessary to produce Product using Pfenex Expression TechnologyTM and all of its component parts, (iv) the
inspection and the structural and mechanical conditions of any and all equipment
and materials included in or added to the equipment
necessary to produce Product using Pfenex Expression TechnologyTM,
and (v) the training of the operating and maintenance personnel.


 


Article 3                                               MILESTONE
AND MAINTENANCE PAYMENTS, ROYALTIES, AND ROYALTY REPORTS


 


3.01         Milestone & Maintenance  Payments:  As partial consideration for the 


 


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granting
of this license, VGX agrees to pay Dow:


 


(a)           the sum of ****** payable annually on each anniversary of
the acceptance of an Investigational New Drug Application (IND) or the equivalent
filing with a Foreign Regulatory
Authority for the Product ******


 


(b)           the sum of ****** payable within thirty (30) days of
submission for the Product of a Biologics License Application (BLA) or a New
Drug Application (NDA) or the equivalent foreign regulatory authority anywhere
in the world. ******;


 


(c)           the sum of ****** payable within thirty (30) days of receipt of marketing approval for the
Product by the Food and Drug Administration or the equivalent foreign regulatory
authority anywhere in the world.


 


For the avoidance of
doubt these sums shall not be applied against any royalty payments due under Article IV
hereof.


 


3.02         ******


 


3.03         Royalty and Royalty Reports:  Commencing in the calendar year in which the
Product receives regulatory approval, VGX agrees to make written Royalty Reports
to Dow quarterly, where Royalty Reports and Royalties are due quarterly, and
VGX shall use commercially reasonable efforts to provide Royalty Reports within
thirty (30) days of the end of each Calendar Quarter.  The Royalty Report must be submitted within
sixty (60) days after the end of each Calendar Quarter.  Royalty
Reports shall provide the total Net Sales of Product sold or value received
during the preceding three (3) calendar months.  The first Royalty Report shall include all Net
Sales of Product sold from the Effective Date of this Agreement to the date of
said Royalty Report.  Such quarterly
Royalty Reports shall provide the particulars of the sale of Product during
such Calendar Quarter conducted by VGX during the preceding three (3) month
period under this Agreement as are pertinent to a royalty
accounting.  These shall include at least
the following:


 


a.             total sale or transfer of Product and country of sale or
transfer;


b.             deductions applicable, if any;


c.             total Royalties due on such sales or transfers; and


d.             payment of Royalty for the period
of the Royalty Report based on Net Sales of Product.


 


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3.04         Royalty Report after Termination:  VGX shall provide a Termination Royalty Report
to Dow within sixty (60) days after the date of any termination of this Agreement.  The Termination Royalty Report shall provide
the total Product Net Sales up to such date of termination which were not previously
reported to Dow.  Concurrently with the
making of this Termination Royalty Report, VGX will pay to Dow all Royalties due.


 


3.05         Methods for Payment of Milestone Fees
and Royalties:


 


(a)                      Each payment
to Dow shall be made by wire transfer to the following destination:


 


Citibank NA, New York


ABA # 021000089


Account # 4074 – 8654


The Account of DGTI


Ref: royalty payment


 


(b)           Royalty reports shall be addressed to
the following address:


 


DGTI


North American Financial
and Statutory Accounting


2020 Dow Center


Midland, MI 48674


Attn: Treasury Accounting-MISC C.D.


 


or another location in the
United States which Dow may subsequently designate from time to time by notice
to VGX.


 


3.06         Late Payments:  If VGX fails to pay on the due date any amount
which is payable under this Agreement, then, without prejudice to other sections
of this Agreement, that amount shall bear interest compounded quarterly from the
due date until payment is made in full, both before and after any judgment, at
an annual rate of two (2) percentage points above the prime commercial lending
rate quoted by Citibank, New York, NY on the day payment was due, until paid.


 


3.07         Status Reports:  Status reports shall be provided to Dow
annually on January 31st 


 


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of each Calendar Year. In
each report VGX shall provide Licensor a clinical status report detailing the
clinical status and projected commercialization date of each Product. VGX shall
also provide the identity in each report of any research and development
activities that employ the Patent Rights, Pfenex Expression
Technology, Biological Material, or Know-How Technology.  These reports shall be sent to the address
provided in Section 12.01, with a copy to the address provide in Section 3.05(b).


 


Article 4                                               RETENTION
BY VGX AND ACCESS TO RECORDS


 


4.01         Records:  VGX shall keep records in accordance with
customary accounting practices and in sufficient detail showing the amount of
Products sold or otherwise transferred to Third Parties to permit the determination
of royalties due to Dow.  VGX shall keep
complete records relating to the activities and requirements under Article 3
such that records shall be in sufficient detail to enable the Royalties payable
hereunder by VGX to be clearly and fully determined.  VGX further agrees to permit its books and records
relating to the activities and requirements under Article 3, including
without limitation such books and records relating to VGX Partner, to be examined
no more than once in any two consecutive Calendar Quarters to verify the reports
provided under this Agreement, such confidential examination to be made at Dow’s
discretion by either: (i) an independent auditing firm appointed by and at
the expense of Dow, which firm shall be reasonably acceptable to VGX, or (ii) Dow’s
internal auditors.  Such records shall be
kept and examination thereof shall be limited to a period of time no more than
three (3) Calendar Years after the close of the fiscal year to which the records
pertain.  In the event that VGX shall
include a VGX Partner to the extent permitted hereunder, VGX shall (a) cause
such VGX Partner to incorporate audit rights in favor of VGX substantially identical
to the provisions of this Section 4.01, and (b) use commercially reasonable
efforts to enforce such audit rights with respect to such VGX Partner.


 


4.02         Financial Information.  VGX shall provide to Dow annual audited
financial statements, as may be prepared by or on behalf of VGX, within ninety
(90) days after the close of each fiscal year during the Agreement Term, subject
to assumption by Dow of customary and reasonable confidentiality obligations regarding
such information.


 


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Article 5                                               CONFIDENTIALITY


 


5.01                       Confidential
Information:  It is anticipated that
it will be necessary, in connection with their obligations under this
Agreement, for VGX and Dow to disclose to each other Confidential Information.


 


5.02                       Confidentiality
and Limited Use:  With respect to all
Confidential Information, both VGX and Dow agree as follows, it being
understood that “recipient” indicates the Party receiving the confidential,
proprietary information from the other “disclosing” Party. Confidential Information,
Biological Material and Know-How Technology provided or disclosed to the
recipient shall remain the property of the disclosing Party and shall be
maintained in confidence by the recipient and shall not be provided or
disclosed to Third Parties by the recipient and, further, shall not be used
except for purposes contemplated in this Agreement.  Parties may disclose Confidential Information
to officers, directors, employees, associates, agents, consultants, contractors,
and Affiliates.  All confidentiality and
limited use obligations with respect to the Confidential Information shall
terminate fifteen (15) years after the termination date of this Agreement.


 


5.03                       Confidentiality
Exceptions:  Notwithstanding any
provision to the contrary, a Party may disclose Confidential Information of the
other Party provided that the disclosing Party notifies the other Party and
allows the other Party’s attorneys the chance to respond to the request to
disclose Confidential Information directly with the court or government body,
through the disclosing Party’s attorneys if necessary: (i) in connection with an order of a court or
other government body or as otherwise required by or in compliance with law or
regulations; provided that the disclosing Party provides the other Party with
notice and cooperates with the other party in taking reasonable measures
to obtain confidential treatment thereof; (ii) in confidence to recipient’s
attorneys, accountants, banks and financial sources and its advisors, who are
under an obligation of confidentiality; or (iii) in confidence, in
connection with the sale of substantially all the business assets to which this
Agreement relates, so long as, in the case of a disclosure under (ii) or (iii) hereof,
the person or entity to which disclosure is made is bound to confidentiality on
terms consistent with the terms set forth herein. The obligations of


 


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confidentiality and
limited use shall not apply to any of the Confidential Information which:


 


(a)                              is
publicly available by publication or other documented means or later becomes
likewise publicly available through no act or fault of recipient; or


 


(b)                             is
already known to recipient before receipt from the disclosing party, as
demonstrated by recipient’s written records; or


 


(c)                              is
made known to recipient by a Third Party who did not obtain it directly or
indirectly from the disclosing party and who does not obligate recipient to
hold it in confidence; or


 


(d)                             is
independently developed by the recipient as evidenced by credible written
research records of recipient’s employees or agents who did not have access to
the disclosing party’s Confidential Information.


 


Specific information
should not be deemed to be within any of these exclusions merely because it is
embraced by more general information falling within these exclusions.


 


5.04                       Disclosures
to Personnel:  Recipient agrees to
advise those of its officers, directors, employees, associates, agents,
consultants, contractors and Affiliates who become aware of the Confidential
Information, of these confidentiality and limited use obligations and agrees,
prior to any disclosure of Confidential Information to such individuals or
entities, to make them bound by obligations of confidentiality and limited use
no less onerous as those contained in this Agreement.  If VGX requests that Dow send information
and/or materials to a third party contractor, VGX must make such request in
writing to Dow and confirm that the third party contractor is bound by obligations
of confidentiality and limited use no less onerous as those contained in this
Agreement. If Dow requests that VGX send information and/or materials to a
third party contractor, DOW must make such request in writing to VGX and
confirm that the third party contractor is bound by obligations of
confidentiality and limited use no less onerous


 


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as those contained in the
agreement.


 


5.05                       Return
of Confidential Information:  Upon
termination of this Agreement, originals and copies of Confidential Information
in written or other tangible form and all Biological Material shall be returned
to the disclosing party by recipient or destroyed by recipient.  One copy of each document may be retained in
the custody of the recipient’s legal counsel solely to provide a record of what
disclosures were made.


 


5.06                       Confidential
Status of Agreement:  Except insofar
as required to be disclosed by law, rule, regulation, or order (including any
of the rules and regulations of a relevant stock exchange or other
governing body, specifically including the Securities & Exchange
Commission (SEC)):  (a) this
Agreement, the terms of this Agreement, and all financial records and reports
kept and made in accordance with this Agreement, shall be deemed to be
Confidential Information subject to the requirements of Sections 5.02, 5.03,
and 5.04; and (b) neither Party shall (i) make public disclosures
concerning this Agreement, its terms, or financial rights and obligations
without obtaining the prior written consent of the other Party, which consent
shall not be unreasonably withheld, conditioned, or delayed, (ii) respond
to a request for information concerning this Agreement without informing the
other Party before responding to such request, or (iii) publicly disclose
financial terms, payments, records or reports kept or made hereunder unless
under court order or under regulatory order, in each case after all appeals
have been exhausted by the Parties.


 


5.07                       Remedies: Each Party acknowledges and agrees
that due to the unique nature of the other Party’s Confidential Information,
there may be no adequate remedy at law for any breach of its obligations
hereunder, that any such breach may allow such Party or third parties to
unfairly compete with such other Party resulting in irreparable harm to such
other Party, except as otherwise noted in this Agreement.  Therefore, the
breaching Party agrees to grant to the non-breaching Party, a world-wide,
non-exclusive, sublicensable, irrevocable royalty-free license to make, use, or
sell any patentable discovery resulting from breaching Party filing patent
applications related to the unauthorized use of non-breaching Party’s
Confidential Information.  Futhermore, upon


 


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any breach or any threat thereof, such other Party shall be
entitled to seek appropriate equitable relief in addition to whatever remedies
it might have at law.  Each Party will
notify the other Party in writing immediately upon the occurrence of any such
unauthorized release or other breach of which it is aware.


 


Article 6                                               DISCLAIMERS, INDEMNIFICATION,
HOLD HARMLESS AND INSURANCE


 


6.01                       Representations
and Warranties:  Dow has the right to
license Patent Rights and Know-How Technology to the extent required for the
grant of rights contained herein and has the power and authority to enter into
this Agreement.


 


6.02                        No
Other Warranties:


 


EXCEPT FOR THE EXPRESS
WARRANTIES IN SECTION 6.01, DOW MAKES NO REPRESENTATIONS OR WARRANTIES,
EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, REGARDING:


 


PATENT RIGHTS, KNOW-HOW
TECHNOLOGY, IMPROVEMENTS, PFENEX
EXPRESSION TECHNOLOGYTM, PRODUCT AND BIOLOGICAL MATERIAL (INCLUDING, WITHOUT
LIMITATION, THE VALIDITY OR SCOPE OF THE PATENT RIGHTS) OR INCLUDING, WITHOUT
LIMITATION, PERFORMANCE, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR
THE NON-INFRINGEMENT OF ON THIRD PARTY PROPERTY RIGHTS.


 


6.03                       VGX
Indemnification:  Except to the
extent caused by the negligence or willful misconduct of Dow, VGX will defend
and indemnify against, and hold Dow and its employees, directors, officers and
agents harmless from, any loss, cost, liability or expense (including court
costs and reasonable fees of attorneys and other professionals) incurred from
any claim arising or alleged to arise out of the manufacture, use, distribution
or sale of product by VGX; provided, however, that (i) VGX shall have sole
control of such defense, (ii) Dow shall provide notice promptly to VGX of
any actual or threatened claim of which Dow becomes aware, (iii) and VGX
has no indemnification


 


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obligations or liability
for any claim that is based solely upon the use by VGX of patent rights,
biological material or Pfenex
Expression TechnologyTM.  In no event shall Dow be liable for
any consequential, special, punitive,
exemplary, indirect or incidental damages arising from this agreement or
performance under this Agreement (including loss of anticipated profits, loss
of use, or loss of product).  VGX
will bear responsibility with regard to any matter arising out of or related to
the VGX’s use of Dow’s Patent Rights, Know-How Technology, Improvements, Pfenex Expression TechnologyTM, and Biological Material,
except to the extent that such liability is due to negligence or willful
misconduct of Dow. VGX has the duty to promptly notify Dow of any claim
relating to Dow’s Patent Rights, Know-How Technology, Improvements, Pfenex Expression TechnologyTM, and Biological Material or
the Product.  Additionally, Dow has the
right to assume and/or participate in the defense of any claim.


 


6.04                       Dow
Indemnification:   Except to the
extent caused by the negligence or willful misconduct of VGX, Dow will defend
and indemnify against, and hold VGX, and its employees, officers, directors and
agents harmless from any loss, cost, liability or expense *****.  Dow shall have sole control of such defense.  In
no event shall VGX be liable for any consequential, special, punitive,
exemplary, indirect or incidental damages arising from this agreement or
performance under this Agreement (including loss of anticipated profits, loss
of use, or loss of product).  This waiver
applies regardless of whether or not the damages were foreseeable, and
regardless of the theory or cause of action upon which the damages might be
based.


 


6.05                       Limited
Liability:  Neither party shall be
liable to the other for any loss of profits, loss of business, interruption of
business, indirect, special or consequential damages of any kind suffered by
such other party for breach hereof, whether based on contract or tort claims or
otherwise, even if such party has been advised of the possibility of such loss.


 


6.06                       VGX Insurance:  At
all times while this Agreement is in effect, VGX will procure and maintain, at
its own expense and for its own benefit, Comprehensive/Commercial General
Liability Insurance, including coverage for Contractual Liability and Products
Liability (including coverage for human clinical 


 


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trials),
having a bodily injury, death, and property damage combined single limit of at
least ****** per occurrence.  Prior to
commencement of any commercial product sales, VGX will procure and maintain, at
its own expense and for its own benefit, Product Liability insurance having a
bodily injury, death, and property damage combined single limit of at least
****** per occurrence.  The scope of the
Product Liability coverage to be provided is to be similar to standard ISO
forms (e.g. 1998 Commercial General Liability ISO form #CG 00 01 01 98 or CG 00
02 01 98). If the insurance to be provided is in a form similar to ISO policy
form CG 00 02 01 98 (claims made form), then the policy shall contain an
extended reporting period; of at least three (3) years; any Retroactive
Date under said policy shall be no later than the Effective Date of this
Agreement.


 


(a) 
VGX will furnish Dow a certificate(s) from an insurance carrier or
carriers (having a minimum AM Best rating of A-) showing all insurance set forth
above.  The certificate(s) will
include the following statement:  “The
insurance certified hereunder is applicable to contracts between Dow Global
Technologies Inc. and the Insured.  This
insurance may be canceled or altered only after thirty (30) days written notice
to Dow Global Technologies Inc.”  The
insurance will be endorsed and the certificate(s) will confirm that the
insurance (1) names Dow Global Technologies Inc. and its affiliates as
additional insureds with respect to the liability of VGX arising from this
Agreement; (2) provides that such insurance is primary and
non-contributing to any liability insurance carried by Dow Global Technologies
Inc.; and (3) provides that underwriters and insurance companies of VGX
may not have any right of subrogation against Dow Global Technologies Inc. and
its affiliates.  The insurance will
contain no more than a typical industry deductible/SIR.


 


6.07                           Dow
Insurance: At all times
while this Agreement is in effect, Dow will maintain, at its own expense and
for its own benefit, Comprehensive/Commercial General Liability (CGL)
Insurance, including coverage for Contractual Liability, having a bodily
injury, death, and property damage combined single limit of at least ******  per occurrence.  Upon request Dow will furnish VGX a
certificate(s) from an insurance carrier or carriers (having a minimum AM
Best rating of A-) showing all insurance set forth above.  The certificate(s) will include the


 


16

















 


following
statement:  “The insurance certified
hereunder is applicable to contracts between VGX Pharmaceuticals, Inc. and
the Insured.  This insurance may be
canceled or altered only after thirty (30) days written notice to VGX
Pharmaceuticals, Inc.”  The
insurance will be endorsed and the certificate(s) will confirm that (1) the
insurance names VGX Pharmaceuticals, Inc and its Affiliates as additional
insureds with respect to the liability of Dow arising from this Agreement; (2) provides
that such insurance is primary and non-contributing to any liability insurance
carried by VGX Pharmaceuticals, Inc.; and (3) provides that
underwriters and insurance companies of Dow may not have any right of
subrogation against VGX Pharmaceuticals, Inc. and its affiliates.  The insurance will contain no more than a
typical industry deductible/SIR.


 


6.08                       Dow
and VGX each agree to waive any right of recovery against the other and their
respective Affiliates for any loss or damage of the type covered by the
insurance to be procured and maintained under this Agreement regardless of
whether or not such insurance is so maintained.


 


6.09                       Failure
of any of the terms and conditions of the Insurance provision will be deemed a
material breach of this Agreement.


 


Article 7                                               PATENTS, IMPROVEMENTS AND
INFRINGEMENT OF DOW’S PATENT RIGHTS BY THIRD PARTIES


 


7.01 Grant-Back:


 


(a)  When an
Improvement is made or discovered by VGX and/or its Affiliates, and such
Improvement would not have arisen but for the presence of Pfenex
Expression TechnologyTM,
Biological Material, or Know-How Technology, and such Improvement relates to Pfenex Expression TechnologyTM, Biological Material, or Know-How
Technology and do not include Product, VGX and its employees and/or its
Affiliates hereby assign its entire right, title and interest in such
Improvement to Dow and agree to cooperate with Dow in obtaining patent
protection therefore at Dow’s cost, including, but not limited to the execution
of any and all lawful papers in the U.S. and foreign patent offices.  Dow hereby grants VGX the ability to use such
Improvement under the terms of


 


17

















 


this Agreement to the
extent Dow has the right to convey the right to practice the Improvement to
Licensee.


 


(b) Notwithstanding
the foregoing, VGX shall not file any patent applications which disclose,
describe or require the presence of Pfenex
Expression TechnologyTM,
Biological Material, or Know-How Technology absent consent from Dow.  For the avoidance of doubt, Dow agrees that
it shall consent to disclosure in patent applications filed by VGX concerning
VGX’s Product and the use of Dow’s Confidential Information as may be
reasonably necessary to comply with the legal standards of disclosure and
description.  Dow will have the right to
review all sections and examples relating to Pfenex
Expression TechnologyTM,
Biological Material, or Know-How Technology thirty (30) days before the filing
of such patent application.  If VGX files
such an application outside the scope of 7.01(a), VGX and/or its Affiliates
hereby grant Dow and its Affiliates irrevocable world-wide, exclusive,
royalty-free licenses to such Improvement with the right to sublicense such
rights to Third Parties, with the right to further sublicense.


 


7.02                       Patent
Infringement:  Should VGX become
aware of any infringement or alleged infringement of any Patent Rights, VGX
shall promptly notify Dow in writing of the name and address of the alleged
infringer and of the alleged acts of infringement, and provide any available
evidence of the alleged acts of infringement. 
Dow shall not be obligated to prosecute against any Third Party any suit
for infringement of the aforesaid Patent Rights.  In the event that Dow decides to bring a
patent infringement suit against the alleged Third Party infringer, VGX shall
cooperate with Dow in the prosecution of any legal infringement action and
agrees to provide Dow with pertinent data and evidence which may be helpful in
the prosecution of such action of which it may have knowledge or which may be
readily available to it.    Dow shall
reimburse VGX for reasonable expenses incurred by VGX in assisting Dow in this
matter.  Dow shall have the exclusive
right (but not the obligation) to institute and conduct legal action against
Third Party infringers of the Patent Rights, and to enter into such settlement
agreements as may be deemed appropriate by Dow. 
Dow shall receive the full benefits of any compensatory or punitive
damages it obtains pursuant to bringing such suit.


 


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7.03                       Invalidity
of Patent Rights:  If, at any time
during this Agreement, Dow shall be unable to uphold the validity of any of the
Patent Rights against any alleged infringer, VGX shall not have or assert any
damage claim or a claim for refund or reimbursement against Dow.  In the event that Patent Rights are not
upheld, royalties shall continue under this Agreement for VGX’s rights under Pfenex Expression TechnologyTM.  However, in the event Patent Rights are not
upheld and VGX is required to pay duplicate royalties to a Third Party, VGX
shall pay Dow a reduced royalty rate of the royalty rate minus the duplicate
royalty rate.  For the purpose of clarity
any patent that has not been withdrawn, cancelled, abandoned, disclaimed,
revoked or held unpatentable, invalid or unenforceable by a final decision of a
court or other governmental agency of competent jurisdiction, which decision is
unappealable or unappealed within the time allowed for appeal is considered to
be valid and upheld.


 


7.04                       Challenges:
VGX, VGX affiliates, VGX Partners, or sublicensees are not permitted directly
or indirectly, to challenge the validity or enforceability of any of Patent
Rights.  Such breach shall result in
termination of this license.


 


Article 8                                               ASSIGNABILITY/SUCCESSION/CHANGE
IN CONTROL


 


8.01                       VGX
Assignability:  The rights acquired
herein by VGX are not assignable or transferable in whole or part (by
assignment, merger, succession, operation of law or otherwise) to any Third
Party, without prior written permission from Dow, which Dow may withhold in its
absolute discretion.  A change of control shall be considered for
purposes of this paragraph a transfer of the Agreement.  A “change of control” means a change in the
direct or indirect power to direct or cause the direction of the management and
policies of VGX, whether through ownership or voting securities, by contract or
otherwise, or the sale of fifty percent (50%) or more of the equity interest of
VGX.  Any attempted assignment in
violation of this provision shall be void. 
In the event of a “change
in control” of VGX, VGX shall promptly notify Dow of such change in control and
Dow shall be permitted to terminate the Agreement subject to the provisions of Section 10.05.  Notwithstanding the foregoing, in the event
that all of the equity and assets of VGX are acquired by a Third Party, Dow
will provide its written permission for


 


19

















 


the
Agreement to be transferred, provided such Third Party agrees in writing to be
bound by the terms and conditions of this Agreement.


 


8.02                       Dow
Assignability:   Dow shall have the
right to assign this Agreement in connection with the reorganization,
consolidation, spin-off, sale or transfer of assets related to that portion of
its business pertaining to the subject matter of this Agreement, either alone
or in conjunction with other Dow businesses. 
In addition, Dow shall have the right to assign its respective rights or
obligations and delegate its performance hereunder, in whole or in part, to any
of its Affiliates.  In either event, the
assignee shall agree in writing to be bound by all the terms of this Agreement.


 


Article 9                                               UNITED
STATES GOVERNMENT EXPORT CONTROL REGULATIONS


 


9.01                       Export
Control Regulations:  The Parties
acknowledge that, in the course of performing under this Agreement, they may
have access to certain information about the production and/or development of
certain materials that are subject to export control regulations of the U.S.
Department of Commerce and require a specific license from that agency before
such technology can be transferred outside the United States or disclosed in
the United States to nationals of other countries (unless such individuals have
been granted U.S. citizenship, permanent residence, or legal status) (the “Controlled
Technology”).  In addition to the
obligations imposed by Article 5, each Party agrees not to release
Controlled Technology that it may obtain from the other Party unless it is
released to (i) a U.S. citizen, (ii) an individual who currently
holds permanent resident or asylee status in the United States, or (iii) pursuant
to a license granted by the U.S. Department of Commerce.


 


Article 10                                        TERM
AND TERMINATION


 


10.01                 Term:  Unless
previously terminated in accordance with the following provisions of this Article 10,
this Agreement is effective as of the Effective Date of this Agreement and
shall expire, on a country-by-country basis, (i) ten (10) years from
the date of first sale of a Product, or (ii) expiration of the last to
expire patent in the Patent Rights licensed hereunder, whichever is longer.
Upon such expiration, all rights and licenses


 


20














 


granted to VGX hereunder
shall become irrevocable and fully paid-up.


 


10.02                   VGX’s Right
to Terminate:  VGX shall have the
right to terminate this Agreement one (1) Calendar Year after the
Effective Date, provided VGX provides thirty (30) days written notice of such
termination. Notwithstanding the previous sentence, in the event VGX withdraws
its IND or no longer seeks regulatory approval for the Product, VGX shall have
the right to terminate this agreement by providing thirty (30) days written
notice of such termination.


 


10.03                   Dow’s Right
to Terminate:  Dow shall have the
right to terminate this Agreement by giving thirty (30) days written notice to
VGX if substantial health and safety risks associated with the Pfenex Expression TechnologyTM used by VGX create a material
risk to Dow (after taking into account VGX’s indemnification obligations, any
insurance coverage provided by VGX or held by Dow, and defenses available to
VGX (including without limitation product liability defenses and
indemnification of government contractors) that cannot be mitigated short of
termination.


 


10.04                   Termination
of Agreement for Breach:


 


(a)                      Either
Party may terminate this Agreement upon at least thirty (30) days written
notice to the other Party should the other party commit a material breach of
its obligations or be in default under any of the provisions of this Agreement
if: (i) the Party in breach has failed to cure the breach or default
within the same thirty (30) day notice period; (ii) if such breach or
default cannot be cured within the thirty (30) day period, and the Party in
breach has not taken reasonable steps to cure the breach or default.  If the breach or default can not be cured
within the thirty (30) day period, the Party in breach shall notify the
non-breaching Party of the steps taken toward curing such default or breach and
the plans to totally cure such default or breach as soon as reasonably
possible.  If the Party in breach fails
to provide such notice, the non-breaching Party shall be free to terminate with
immediate effect by notice to the Party in breach.


 


21

















 


(b)                     If VGX shall at any time default in the payment of any license fee,
milestone fee or royalty or in the making of any report hereunder, or shall
commit any material breach of any covenant herein contained, and shall fail to
remedy any such default or breach within thirty (30) days after written notice
thereof by DOW, then DOW may, at its option, terminate the license and all
other rights herein granted, by giving notice to VGX in writing to such effect.


 


(c)                      Notwithstanding
a Party’s right to terminate this Agreement as a result of a non-cured material
breach by the other Party, the non-breaching Party shall not be prevented from
seeking any other remedy which may be available to it in equity, including
specific performance on the part of the party in breach.


 


(d)                     In
the event that reasonable grounds for insecurity arise with respect to the
performance of VGX’s obligations to timely pay any Royalty hereunder, Dow may
in writing demand adequate assurance of due performance and, if VGX does not
provide such adequate assurance in a manner reasonably satisfactory to Dow
within thirty (30) days of such demand, Dow may, at it’s option, terminate this
Agreement upon written notice to VGX.


 


10.05                   Insolvency:  Either Party may terminate this Agreement if,
at any time:


 


(a)                      the
other Party makes an assignment for the benefit of creditors or admits in
writing its inability generally to pay or is generally not paying its debts as
such debts become due;


 


(b)                     any
decree or order for relief is entered against the other Party under any
bankruptcy, reorganization, compromise, arrangement, insolvency, readjustment
of debt, dissolution or liquidation or similar law;


 


(c)                      the
other Party petitions or applies to any tribunal for, or consents to, the 


 


22

















 


appointment of, or taking
possession by, a trustee, receiver, custodian, liquidator or similar official,
of such other Party or any substantial part of its assets, or commences a
voluntary case under the bankruptcy law of any jurisdiction;


 


(d)                     any
such petition or application is filed, or any such proceedings are commenced,
against the other Party and such other Party by any act indicates its approval
thereof, consent thereto or acquiescence therein, or an order, judgment or
decree is entered appointing any such trustee, receiver, custodian, liquidator
or similar official, or approving the petition in any such proceedings, and
such order for relief, order, judgment or decree remains unstayed and in effect
for more than sixty (60) days; or


 


(e)                      any
order, judgment or decree is entered in any proceedings against the other Party
decreeing the dissolution of such other Party and such order, judgment or
decree remains unstayed and in effect for more than sixty (60) days.


 


10.06                   Effects of Termination/Survival:


 


(a)                      Expiration
or termination of this Agreement shall not relieve the Parties of any
obligation accruing prior to or upon such expiration or termination.  Accordingly, Dow rights under Article [7]
shall survive expiration of termination of this Agreement for any reason.  Sections [3.04, Articles 5 and Article 6]
shall survive expiration or termination of this Agreement and VGX shall not be
relieved of any payment obligation that may have accrued prior to such
expiration or termination.


 


(b)                     Upon
an early termination of this Agreement due to a change of control of VGX, VGX
shall, except in the case of a breach by VGX, insolvency by VGX as specified in
this Article, be entitled to sell, for a period of twelve (12) months,
remaining inventories of any Product(s) which are already in its
possession.  Such sales shall be in
accordance with this Agreement and 


 


23

















 


the Parties shall
continue to be obligated to make all applicable payments hereunder.


 


(c)                      After
termination, except as provided in (b) above, any remaining Product and
all Biological Material and Confidential Information relating, if any, shall be
destroyed or shall be returned, respectively, and the destruction shall be
certified to Dow by a representative of VGX.


 


10.07                   Termination
for Violations:    Violation of the
U.S. Export Control laws or regulations by VGX shall constitute grounds for
Dow, in its sole discretion, to terminate this license agreement.  Failure to obtain any needed export control
license may result in criminal liability under the United States law.


 


Article 11                                        ADVERTISING/PUBLICITY


 


11.01                   Neither the
granting of the license herein granted by Dow nor the acceptance of the
milestone payments or royalties hereunder by Dow shall constitute Dow’s
approval of, or acquiescence in, advertising or other business practices of
VGX, nor an approval of or acquiescence in any use of the corporate name of
Dow, use of the name(s) of the inventors of the Patent Rights licensed, in
connection with the manufacture, advertising, use or sale of Product, and Dow
hereby expressly reserves all rights of actions with respect thereto.


 


11.02                   Dow and VGX
hereby agree to issue a joint press release upon signing of this
Agreement.  The wording of said press
release shall be mutually agreed by both parties prior to issuance.


 


Article 12                                        NOTICES


 


12.01 Notices:  Any notice or other communication required or
permitted to be given by either party under this Agreement shall be given in
writing and shall be effective when delivered, if delivered by hand, reputable
courier service or five days after mailing if mailed by registered or certified
mail, postage prepaid and return receipt requested, addressed to each party at
the following addresses or such other address as may be 


 


24

















 


designated by written
notice by either Party:


For Dow Global Technologies
Inc.:


Dowpharma – Business
Leader


The Dow Chemical Company


5501 Oberlin Drive


San Diego, CA 92121


 


With a copy to:


The
Dow Chemical Company


9330
Zionsville Road


Indianapolis,
IN 46268


Attention:
General Patent Counsel


 


For VGX:


 


VGX Pharmaceuticals, Inc.


450 Sentry Parkway


Blue Bell, PA 19422


Attention: J. Joseph Kim


 


Article 13                                        MISCELLANEOUS


 


13.01                   Severability:  If any clause, provision, or section of this
Agreement attached hereto, shall, for any reason, be held illegal, invalid or
unenforceable, the parties shall negotiate in good faith and in accordance with
reasonable standards of fair dealing, a valid, legal, and enforceable
substitute provision or provisions that most nearly reflect the original intent
of the parties under this Agreement in a manner that is commensurate in
magnitude and degree with the changes arising as a result of any such
substitute provision or provisions.  All
other provisions in this Agreement shall remain in full force and effect and shall
be construed in order to carry out the original intent of the parties as nearly
as possible (consistent with the necessary reallocation of benefits) and as if
such invalid, illegal, or unenforceable provision had never been contained
herein.


 


25

















 


13.02                   Merger of
Understanding:  Except for the
Confidentiality Agreement signed December 12, 2005 and the Services
agreement signed on February 8, 2006 this Agreement constitutes the entire
Agreement between the Parties regarding the subject matter hereof and all prior
negotiations and understandings between the parties are deemed to be merged
into this Agreement.


 


13.03                   Force
Majeure:  Neither of the Parties
shall be liable for any default or delay in performance of any obligation under
this Agreement caused by any of the following: Act of God, war, terrorism,
riot, fire, explosion, accident, flood, sabotage, compliance with governmental
requests, laws, regulations, orders or actions, national defense requirements
or any other event beyond the reasonable control of such Party; or labor
trouble, strike, lockout or injunction (provided that neither of the Parties
shall be required to settle a labor dispute against its own best
judgment).   The party invoking the provisions
of this Section shall give the other Party written notice and full
particulars of such force majeure event. 
Both Dow and VGX shall use reasonable business efforts to mitigate the
effects of any force majeure on their respective part.


 


13.04                   Relationship
of the Parties: The
relationship of Dow and VGX is strictly one of independent contractors and the
parties acknowledge that this Agreement does not create a joint venture,
partnership, or the like, between them. 
VGX and DOW shall always remain independent contractors in its
performance of this Agreement.  Neither
party to this Agreement shall have any authority to employ any person as an
employee or agent for or on behalf of the other party to this Agreement for any
purpose, and neither party to this Agreement, nor any person performing any
duties or engaging in any work at the request of such party, shall be deemed to
be an employee or agent of the other party to this Agreement.


 


13.05                   Choice of
Law; Submission to Jurisdiction:  All
questions with respect to the construction of this Agreement and the rights and
liabilities of the Parties hereto shall be determined in accordance with the
laws of the State of Delaware applicable to business arrangements entered into
and performed entirely within the State of Delaware.  The 


 


26

















 


Parties hereto
irrevocably (a) submit to the exclusive personal jurisdiction of any state
court or federal court in the State of Delaware in any suit, action or other
legal proceeding relating to this Agreement; (b) agree that all claims in
respect of any such suit, action or other legal proceeding may be heard and
determined in, and enforced in and by, any such court; and (c) waive any
objection that they may now or hereafter have to venue in any such court or
that such court is an inconvenient forum.


 


13.06                   Provisions
Contrary to Law:  In performing this
Agreement, the Parties shall comply with all applicable laws and
regulations.  Nothing in this Agreement
shall be construed so as to require the violation of any law, and wherever
there is any conflict between any provision of this Agreement and any law the
law shall prevail, but in such event the affected provision of this Agreement
shall be affected only to the extent necessary to bring it within the
applicable law.


 


13.07                   Remedies:  Except as otherwise expressly stated in this
Agreement, the rights and remedies of a party set forth herein with respect to
failure of the other to comply with the terms of this Agreement (including,
without limitation, rights of full termination of this Agreement) are not
exclusive, the exercise thereof shall not constitute an election of remedies
and the aggrieved party shall in all events be entitled to seek whatever
additional remedies may be available in law or in equity.


 


13.08                   Fees:  Except as otherwise provided herein, each
Party shall bear its own legal fees incurred in connection with the
transactions contemplated hereby.


 


13.09                   Headings:  Headings herein are for convenience of
reference only and shall in no way affect interpretation of this Agreement.


 


13.10                   Counterparts:  This Agreement may be executed in any number
of counterparts with the same effect as if all parties had signed the same
document. All such counterparts shall be deemed an original, shall be construed
together and shall constitute one and the same instrument.


 


27

















 


13.11                   Appendices:  The appended Appendices and any modifications
or amendments thereof form an integral part of this Agreement.


 


IN WITNESS
WHEREOF, the Parties hereto have understood, agreed to and caused this
Agreement to be executed in duplicate originals by their duly authorized
representatives as of the date written beneath their respective signatures.


 


	
  Dow Global Technologies Inc.

  	
   

  	
  VGX Pharmaceuticals, Inc.

  
	
  (Licensor)

  	
   

  	
  (VGX)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By: 

  	
  /s/ James M. Blatt

  	
   

  	
  By: 

  	
  /s/ J. Joseph Kim

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name: 

  	
  James M. Blatt

  	
   

  	
  Name: 

  	
  J. Joseph Kim

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title: 

  	
  President

  	
   

  	
  Title: 

  	
  President and C.E.O.

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date: 

  	
  April 18, 2007

  	
   

  	
  Date: 

  	
  March 13, 2007

  



 


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