Document:

EXHIBIT 10.65

 

Portions Subject to Confidential Treatment Request Under Rule 406

 

 

LICENSE
AGREEMENT

 

 

by and between

 

VGX
PHARMACEUTICALS, INC.,

 

 

and

 

GENETRONICS,
INC.

 

 

November 9, 2006

 

 

TABLE OF CONTENTS

 

	
   

  	
   

  	
  Page(s)

  
	
   

  	
   

  	
   

  
	
  1.

  	
  DEFINITIONS

  	
  1

  
	
   

  	
   

  	
   

  
	
  1.1.

  	
  Additional Third Party License

  	
  1

  
	
   

  	
   

  	
   

  
	
  1.2.

  	
  Affiliate(s)

  	
  1

  
	
   

  	
   

  	
   

  
	
  1.3.

  	
  Applicator

  	
  2

  
	
   

  	
   

  	
   

  
	
  1.4.

  	
  Calendar Quarter

  	
  2

  
	
   

  	
   

  	
   

  
	
  1.5.

  	
  Calendar Year

  	
  2

  
	
   

  	
   

  	
   

  
	
  1.6.

  	
  Change of Control

  	
  2

  
	
   

  	
   

  	
   

  
	
  1.7.

  	
  Clinical Trial

  	
  2

  
	
   

  	
   

  	
   

  
	
  1.8.

  	
  Commercialize

  	
  2

  
	
   

  	
   

  	
   

  
	
  1.9.

  	
  Confidential Information

  	
  2

  
	
   

  	
   

  	
   

  
	
  1.10.

  	
  Control or Controlled

  	
  3

  
	
   

  	
   

  	
   

  
	
  1.11.

  	
  Develop

  	
  3

  
	
   

  	
   

  	
   

  
	
  1.12.

  	
  Development Term

  	
  3

  
	
   

  	
   

  	
   

  
	
  1.13.

  	
  Device

  	
  3

  
	
   

  	
   

  	
   

  
	
  1.14.

  	
  EP

  	
  4

  
	
   

  	
   

  	
   

  
	
  1.15.

  	
  Existing EP Intellectual Property

  	
  4

  
	
   

  	
   

  	
   

  
	
  1.16.

  	
  Existing Genetronics Know-How

  	
  4

  
	
   

  	
   

  	
   

  
	
  1.17.

  	
  Existing Genetronics Patent Rights

  	
  4

  
	
   

  	
   

  	
   

  
	
  1.18.

  	
  Existing Genetronics Patents

  	
  4

  
	
   

  	
   

  	
   

  
	
  1.19.

  	
  FDA

  	
  4

  
	
   

  	
   

  	
   

  
	
  1.20.

  	
  FD&C Act

  	
  4

  
	
   

  	
   

  	
   

  
	
  1.21.

  	
  First Commercial Sale

  	
  4

  
	
   

  	
   

  	
   

  
	
  1.22.

  	
  FTE

  	
  4

  

 

 

	
  1.23.

  	
  GAAP

  	
  4

  
	
   

  	
   

  	
   

  
	
  1.24.

  	
  Genetic
  Construct

  	
  4

  
	
   

  	
   

  	
   

  
	
  1.25. 

  	
  Generator

  	
  4

  
	
   

  	
   

  	
   

  
	
  1.26.

  	
  Genetronics Competitor

  	
  5

  
	
   

  	
   

  	
   

  
	
  1.27.

  	
  Genetronics Costs

  	
  5

  
	
   

  	
   

  	
   

  
	
  1.28.

  	
  Genetronics Product Enhancements

  	
  5

  
	
   

  	
   

  	
   

  
	
  1.29.

  	
  Genetronics EP Technology

  	
  5

  
	
   

  	
   

  	
   

  
	
  1.30.

  	
  Genetronics Know-How

  	
  5

  
	
   

  	
   

  	
   

  
	
  1.31.

  	
  Genetronics Licensed Technology

  	
  5

  
	
   

  	
   

  	
   

  
	
  1.32.

  	
  Genetronics Patent Rights

  	
  5

  
	
   

  	
   

  	
   

  
	
  1.33.

  	
  Genetronics Third Party Agreement

  	
  5

  
	
   

  	
   

  	
   

  
	
  1.34.

  	
  IND

  	
  5

  
	
   

  	
   

  	
   

  
	
  1.35.

  	
  Indication

  	
  6

  
	
   

  	
   

  	
   

  
	
  1.36.

  	
  Joint IP

  	
  6

  
	
   

  	
   

  	
   

  
	
  1.37.

  	
  Joint Know-How

  	
  6

  
	
   

  	
   

  	
   

  
	
  1.38.

  	
  Joint Patent Right

  	
  6

  
	
   

  	
   

  	
   

  
	
  1.39.

  	
  Joint Collaboration Technology

  	
  6

  
	
   

  	
   

  	
   

  
	
  1.40.

  	
  Know-How

  	
  6

  
	
   

  	
   

  	
   

  
	
  1.41.

  	
  Licensed Fields

  	
  6

  
	
   

  	
   

  	
   

  
	
  1.42.

  	
  Licensed Product

  	
  6

  
	
   

  	
   

  	
   

  
	
  1.43.

  	
  Major Market Country

  	
  6

  
	
   

  	
   

  	
   

  
	
  1.44.

  	
  Manufacture

  	
  6

  
	
   

  	
   

  	
   

  
	
  1.45.

  	
  Marketing Application

  	
  6

  
	
   

  	
   

  	
   

  
	
  1.46.

  	
  Net Sales

  	
  6

  
	
   

  	
   

  	
   

  
	
  1.47.

  	
  Patent Rights

  	
  7

  

 

 

	
  1.48.

  	
  Person

  	
  7

  
	
   

  	
   

  	
   

  
	
  1.49.

  	
  Phase I Clinical Trial

  	
  7

  
	
   

  	
   

  	
   

  
	
  1.50.

  	
  Phase II Clinical Trial

  	
  7

  
	
   

  	
   

  	
   

  
	
  1.51.

  	
  Phase III Clinical Trial

  	
  7

  
	
   

  	
   

  	
   

  
	
  1.52.

  	
  Product Data

  	
  8

  
	
   

  	
   

  	
   

  
	
  1.53.

  	
  Promotion

  	
  8

  
	
   

  	
   

  	
   

  
	
  1.54.

  	
  Recall

  	
  8

  
	
   

  	
   

  	
   

  
	
  1.55.

  	
  Registrational Filing

  	
  8

  
	
   

  	
   

  	
   

  
	
  1.56.

  	
  Regulatory Approval

  	
  8

  
	
   

  	
   

  	
   

  
	
  1.57.

  	
  Regulatory Authority

  	
  8

  
	
   

  	
   

  	
   

  
	
  1.58.

  	
  Regulatory Marketing Authorization

  	
  8

  
	
   

  	
   

  	
   

  
	
  1.59.

  	
  Right of Reference

  	
  8

  
	
   

  	
   

  	
   

  
	
  1.60.

  	
  Samples

  	
  9

  
	
   

  	
   

  	
   

  
	
  1.61.

  	
  Sublicense

  	
  9

  
	
   

  	
   

  	
   

  
	
  1.62.

  	
  Sublicensee

  	
  9

  
	
   

  	
   

  	
   

  
	
  1.63.

  	
  Term

  	
  9

  
	
   

  	
   

  	
   

  
	
  1.64.

  	
  Territory

  	
  9

  
	
   

  	
   

  	
   

  
	
  1.65.

  	
  Third Party

  	
  9

  
	
   

  	
   

  	
   

  
	
  1.66.

  	
  Trademark

  	
  9

  
	
   

  	
   

  	
   

  
	
  1.67.

  	
  Valid Claim

  	
  9

  
	
   

  	
   

  	
   

  
	
  1.68.

  	
  VGX Device Improvements

  	
  9

  
	
   

  	
   

  	
   

  
	
  1.69.

  	
  VGX Know-How

  	
  9

  
	
   

  	
   

  	
   

  
	
  1.70.

  	
  VGX Licensed Technology

  	
  9

  
	
   

  	
   

  	
   

  
	
  1.71.

  	
  VGX Patent Rights

  	
  9

  
	
   

  	
   

  	
   

  
	
  1.72.

  	
  VGX Product Data

  	
  10

  

 

 

	
  1.73.

  	
  VGX Regulatory Approvals

  	
  10

  
	
   

  	
   

  	
   

  
	
  1.74.

  	
  VGX Sublicensee

  	
  10

  
	
   

  	
   

  	
   

  
	
  2.

  	
  LICENSE GRANTS

  	
  10

  
	
   

  	
   

  	
   

  
	
  2.1.

  	
  Licenses to VGX

  	
  10

  
	
   

  	
   

  	
   

  
	
  2.2.

  	
  Product Enhancements

  	
  11

  
	
   

  	
   

  	
   

  
	
  2.3.

  	
  Direct Licenses to Affiliates

  	
  11

  
	
   

  	
   

  	
   

  
	
  2.4.

  	
  Right of Reference

  	
  11

  
	
   

  	
   

  	
   

  
	
  2.5.

  	
  No Other Rights

  	
  12

  
	
   

  	
   

  	
   

  
	
  3.

  	
  COORDINATION

  	
  12

  
	
   

  	
   

  	
   

  
	
  3.1.

  	
  Development Liaison Representative

  	
  12

  
	
   

  	
   

  	
   

  
	
  3.2.

  	
  Responsibiloites of Development Liaison Representatives

  	
  12

  
	
   

  	
   

  	
   

  
	
  4.

  	
  PRODUCT DEVELOPMENT AND COMMERCIALIZATION

  	
  12

  
	
   

  	
   

  	
   

  
	
  4.1.

  	
  General

  	
  12

  
	
   

  	
   

  	
   

  
	
  4.2.

  	
  Diligence

  	
  12

  
	
   

  	
   

  	
   

  
	
  4.3.

  	
  Regulatory Responsibilities

  	
  13

  
	
   

  	
   

  	
   

  
	
  4.4

  	
  Regulatory Documentation-Device

  	
  13

  
	
   

  	
   

  	
   

  
	
  4.5

  	
  Commercialization Responsibilities

  	
  14

  
	
   

  	
   

  	
   

  
	
  5.

  	
  MANUFACTURING AND SUPPLY

  	
  15

  
	
   

  	
   

  	
   

  
	
  5.1.

  	
  General

  	
  15

  
	
   

  	
   

  	
   

  
	
  5.2.

  	
  Diligence

  	
  15

  
	
   

  	
   

  	
   

  
	
  5.3.

  	
  Genetic Construct Manufacture

  	
  15

  
	
   

  	
   

  	
   

  
	
  5.4.

  	
  Device Manufacture

  	
  15

  
	
   

  	
   

  	
   

  
	
  6.

  	
  CONSIDERATION

  	
  15

  
	
   

  	
   

  	
   

  
	
  6.1.

  	
  Upfront Payment

  	
  15

  
	
   

  	
   

  	
   

  
	
  6.2.

  	
  Development Payments

  	
  15

  
	
   

  	
   

  	
   

  
	
  6.3.

  	
  Royalty Payments

  	
  16

  

 

 

	
  6.4.

  	
  Reports and Payments

  	
  17

  
	
   

  	
   

  	
   

  
	
  7.

  	
  MUTUAL COVENANTS

  	
  19

  
	
   

  	
   

  	
   

  
	
  7.1.

  	
  Confidentiality

  	
  19

  
	
   

  	
   

  	
   

  
	
  7.2.

  	
  Compliance with Law

  	
  20

  
	
   

  	
   

  	
   

  
	
  8.

  	
  REPRESENTATIONS AND WARRANTIES

  	
  21

  
	
   

  	
   

  	
   

  
	
  8.1.

  	
  Representations and Warranties of Each Party

  	
  21

  
	
   

  	
   

  	
   

  
	
  8.2.

  	
  Additional Representations and Warranties of Genetronics

  	
  21

  
	
   

  	
   

  	
   

  
	
  8.3.

  	
  Representation by Legal Counsel

  	
  21

  
	
   

  	
   

  	
   

  
	
  8.4.

  	
  Disclaimer

  	
  22

  
	
   

  	
   

  	
   

  
	
  9.

  	
  INTELLECTUAL PROPERTY

  	
  22

  
	
   

  	
   

  	
   

  
	
  9.1.

  	
  Disclosure

  	
  22

  
	
   

  	
   

  	
   

  
	
  9.2.

  	
  Ownership

  	
  22

  
	
   

  	
   

  	
   

  
	
  9.3.

  	
  Prosecution and Maintenance of Patent Rights

  	
  23

  
	
   

  	
   

  	
   

  
	
  9.4.

  	
  Trademarks

  	
  23

  
	
   

  	
   

  	
   

  
	
  9.5.

  	
  Enforcement of Technology Rights

  	
  24

  
	
   

  	
   

  	
   

  
	
  9.6.

  	
  Third Party Claims

  	
  25

  
	
   

  	
   

  	
   

  
	
  9.7.

  	
  Patent Marking, Certification and Term Restoration

  	
  26

  
	
   

  	
   

  	
   

  
	
  10.

  	
  GOVERNMENT APPROVALS

  	
  26

  
	
   

  	
   

  	
   

  
	
  10.1.

  	
  Each Party’s Obligations

  	
  26

  
	
   

  	
   

  	
   

  
	
  10.2.

  	
  Additional Approvals

  	
  26

  
	
   

  	
   

  	
   

  
	
  11.

  	
  TERM AND TERMINATION

  	
  26

  
	
   

  	
   

  	
   

  
	
  11.1.

  	
  Term

  	
  26

  
	
   

  	
   

  	
   

  
	
  11.2.

  	
  Termination

  	
  27

  
	
   

  	
   

  	
   

  
	
  11.3.

  	
  Insolvency

  	
  27

  
	
   

  	
   

  	
   

  
	
  11.4.

  	
  Change of Control

  	
  29

  

 

 

	
  11.5.

  	
  Accrued Rights

  	
  30

  
	
   

  	
   

  	
   

  
	
  11.6.

  	
  Disposition of Inventory

  	
  30

  
	
   

  	
   

  	
   

  
	
  11.7.

  	
  Survival

  	
  30

  
	
   

  	
   

  	
   

  
	
  12.

  	
  INDEMNIFICATION AND INSURANCE

  	
  30

  
	
   

  	
   

  	
   

  
	
  12.1.

  	
  Indemnification by VGX

  	
  30

  
	
   

  	
   

  	
   

  
	
  12.2.

  	
  Indemnification by Genetronics

  	
  31

  
	
   

  	
   

  	
   

  
	
  12.3.

  	
  Procedure

  	
  31

  
	
   

  	
   

  	
   

  
	
  12.4.

  	
  Insurance

  	
  32

  
	
   

  	
   

  	
   

  
	
  13.

  	
  MISCELLANEOUS

  	
  32

  
	
   

  	
   

  	
   

  
	
  13.1.

  	
  Assignment

  	
  32

  
	
   

  	
   

  	
   

  
	
  13.2.

  	
  Further Actions

  	
  32

  
	
   

  	
   

  	
   

  
	
  13.3.

  	
  Force Majeure

  	
  32

  
	
   

  	
   

  	
   

  
	
  13.4.

  	
  Correspondence and Notices

  	
  33

  
	
   

  	
   

  	
   

  
	
  13.5.

  	
  Amendment

  	
  34

  
	
   

  	
   

  	
   

  
	
  13.6.

  	
  Waiver

  	
  34

  
	
   

  	
   

  	
   

  
	
  13.7.

  	
  Severability

  	
  34

  
	
   

  	
   

  	
   

  
	
  13.8.

  	
  Descriptive Headings

  	
  34

  
	
   

  	
   

  	
   

  
	
  13.9.

  	
  Governing Law; Venue

  	
  34

  
	
   

  	
   

  	
   

  
	
  13.10.

  	
  Entire Agreement

  	
  35

  
	
   

  	
   

  	
   

  
	
  13.11.

  	
  Independent Contractors

  	
  35

  
	
   

  	
   

  	
   

  
	
  13.12.

  	
  Counterparts

  	
  35

  
	
   

  	
   

  	
   

  
	
  13.13.

  	
  Future Relationships

  	
  35

  
	
   

  	
   

  	
   

  
	
  13.14.

  	
  Interpretation

  	
  35

  
	
   

  	
   

  	
   

  
	
  13.15.

  	
  No Third Party Rights or Obligations

  	
  35

  

 

 

	
  SCHEDULES

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Schedule 1.18

  	
  Existing Genetronics Patents

  	
   

  
	
   

  	
   

  	
   

  
	
  Schedule 5.4.1

  	
  Clinical Supply Terms

  	
   

  
	
   

  	
   

  	
   

  
	
  Schedule 6.1

  	
  Upfront Payments

  	
   

  
	
   

  	
   

  	
   

  
	
  Schedule 6.2

  	
  Development Payments

  	
   

  
	
   

  	
   

  	
   

  
	
  Schedule 6.3.2

  	
  Royalty Payments

  	
   

  

 

 

LICENSE AND DEVELOPMENT AGREEMENT

 

This License and Development Agreement (the “Agreement”)
is entered into this 9th day of November, 2006 (the “Effective Date”),
by and between Genetronics, a corporation organized and existing under the laws
of the State of California and having a principal place of business at 11494
Sorrento Valley Road, San Diego, California 92121 (“Genetronics”), and
VGX Pharmaceuticals, Inc., a corporation organized and existing under the
laws of the State of Delaware and having a principal place of business at 450
Sentry Parkway, Blue Bell, PA 19422 (“VGX”).  VGX and Genetronics may each be referred to
herein individually as a “Party” and collectively as the “Parties.”

 

WHEREAS, Genetronics is engaged in the development and
commercialization of human applications of electroporation and possesses rights
to certain patents thereto; and

 

WHEREAS, VGX is engaged in the research, development
and commercialization of human pharmaceutical and biologic products related to
certain nucleic acid-based Genetic Constructs potentially useful in the
treatment of cancer; and

 

WHEREAS, VGX and Genetronics wish to collaborate, on
the terms and conditions set forth in this Agreement, on the development and
commercialization of products combining those Genetic Constructs with
Genetronics’s intratumoral electroporation delivery technology;

 

NOW THEREFORE, in consideration of the mutual promises
and covenants set forth below and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties hereby
agree as follows:

 

1.             DEFINITIONS.

 

Capitalized Terms not otherwise defined herein shall
have the following meanings:

 

1.1.               Additional Third Party License.  “Additional Third Party License” shall have
the meaning set forth in Section 9.6.2 hereof.

 

1.2.               Affiliate(s).  “Affiliate(s)” shall mean 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 Genetronics, agreeing to be
bound by all of the terms and conditions of this Agreement, as if such
Affiliate 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 (50%) of the profits or earnings of a legal entity, and/or the
right to control the policy decisions of a legal entity.   Any reference to VGX Affiliates or VGX and
its Affiliates shall mean Affiliate under this paragraph.   As for Genetronic’s Affiliates the following
shall apply:   Affiliate shall mean, as,
as of any point in time and for so long as such relationship continues to exist
with respect to any Person (as defined below), any other Person which controls,
is controlled by or is under common control with such Person.  A Person shall be regarded as in control of
another Person if it owns or controls at least fifty percent (50%) of the
equity securities of the subject Person entitled to vote in the election of
directors (or, in 

 

 

the case of a Person that is not a corporation, for the election of the
corresponding managing authority); provided, however, that the term “Affiliate”
shall not include subsidiaries or other entities in which a Person owns a
majority of the ordinary voting power necessary to elect a majority of the
board of directors or other governing board, but is restricted from electing
such majority by contract or otherwise, until such time as such restrictions
are no longer in effect.

 

1.3.               Applicator. 
“Applicator” shall mean an existing 6-needle, high voltage (>800V/cm)
Genetronics product designed for use solely with the Generator to deliver a
Genetic Construct by means of intratumoral electroporation, and which product
is intended to be disposed of after one administration to a patient of a
Licensed Product, or after a defined number of such administrations of a
Licensed Product.

 

1.4.               Calendar Quarter.  “Calendar Quarter” shall mean the respective
periods of three (3) consecutive calendar months ending on March 31, June 30,
September 30 or December 31 of each Calendar Year.

 

1.5.               Calendar Year.  “Calendar Year” shall mean any calendar year,
for so long as this Agreement is in effect.

 

1.6.               Change of Control.  “Change of Control” shall mean a transaction
in which VGX: (a) sells, conveys or otherwise disposes of all or
substantially all of its property or business; or (b)(i) merges or
consolidates with any other entity (other than an Affiliate of VGX); or (ii) effects
any other transaction or series of transactions; in each case of clause (i) or
(ii), such that the stockholders of VGX immediately prior thereto, in the
aggregate, no longer own, directly or indirectly, beneficially or legally, at
least fifty percent (50%) of the outstanding voting securities or capital stock
of the surviving entity following the closing of such merger, consolidation,
other transaction or series of transactions.

 

1.7.               Clinical Trial.  “Clinical Trial” shall mean a clinical study
conducted by or for VGX on human subjects pursuant to a protocol approved by an
appropriate regulatory authority, which study is designed to support the
Marketing Application for the Licensed Product that is the subject of such
study.

 

1.8.               Commercialize.  “Commercialize” or “Commercializing” shall
mean to use, import, export, market, Promote, distribute, offer for sale, sell,
have sold or otherwise commercialize or prepare to commercialize.  When used as a noun, “Commercialization”
shall mean any and all activities involved in Commercializing.  “Commercialization” does not include
Development or Manufacturing and to “Commercialize” does not include to Develop
or to Manufacture.

 

1.9.               Confidential Information.  “Confidential Information” means, with
respect to a Party, all information (and all tangible and intangible
embodiments thereof), which is Controlled by such Party, including, without
limitation, (i) scientific or medical information, material, results and
data of any type whatsoever, in any tangible or intangible form whatsoever,
including databases, inventions, practices, methods, techniques,
specifications, formulations, formulae, cell lines, cell media, knowledge,
know-how, skill, 

 

2

 

experience,
manufacturing materials, financial data, test data including pharmacological,
biological, chemical, biochemical, toxicological and clinical test data,
analytical and quality control data, quality assurance data, stability data,
and studies and procedures, (ii) all regulatory filings and communications
or any kind, and patent and other legal information or descriptions and (iii) commercial
information of any kind, including product forecasts and sales information,
sales force information, marketing studies and marketing materials, comparative
analysis of competing products, physician education materials, customer and
distribution channel information, and any information regarding post-approval trials,
adverse event reports, or other product information.  Notwithstanding the foregoing, Confidential
Information of a Party which is disclosed by such Party to the other Party or
otherwise received by the receiving Party shall not include information which
the receiving Party can establish by written documentation (a) was
publicly known prior to its disclosure to or receipt by the receiving Party, (b) became
publicly known, without breach of this Agreement on the part of the receiving
Party or an agent thereof, subsequent to its disclosure to or receipt by the
receiving Party, (c) was received by the receiving Party at any time from
a source, other than the disclosing Party, rightfully having possession of and
the right to disclose such information free of confidentiality obligations, (d) was
otherwise known by the receiving Party free of confidentiality obligations to
the disclosing Party prior to its disclosure to or receipt by the receiving
Party, or (e) was independently developed by employees or others on behalf
of the receiving Party without the aid, application or use of the information
disclosed to or received by the receiving Party.

 

1.10.             Control or Controlled.  “Control” or “Controlled” shall mean with
respect to any material, item of information, or intellectual property right,
the possession, whether by ownership, license or otherwise, of the right to
grant a license or other right with respect thereto to the extent set forth
herein.

 

1.11.             Develop.  “Develop”
or “Developing” shall mean to discover, research, have researched, develop,
have developed or use for development purposes, including conducting
non-clinical and clinical research and development activities such as
toxicology, pharmacology and other discovery efforts, test method development
and stability testing, process development, formulation development, delivery
system development, quality assurance and quality control development,
statistical analysis, clinical studies (including pre- and post-approval
studies), regulatory affairs, pharmacovigilance and Regulatory Approval and
Clinical Trial regulatory activities (including regulatory activities directed
to obtaining pricing and reimbursement approvals).  When used as a noun, “Development” shall mean
any and all activities involved in Developing. 
Development shall not include Manufacturing or Commercialization and to “Develop”
does not include to Commercialize or to Manufacture.

 

1.12.             Development Term.  “Development Term” shall mean the period of
time from the Effective Date until the First Commercial Sale of the first
Licensed Product to be sold in any country in the Territory.

 

1.13.             Device. 
“Device” shall mean a Generator or Applicator.  “Devices” shall mean Generators or
Applicators, or both.

 

3

 

1.14.             EP.  “EP”
shall mean intratumoral electroporation.

 

1.15.             Existing EP Intellectual Property.  “Existing EP Intellectual Property” shall
mean the Existing Genetronics Patent Rights and Existing Genetronics Know-How.

 

1.16.             Existing Genetronics Know-How.  “Existing Genetronics Know-How” shall mean
any Genetronics Know-How Controlled by Genetronics or its Affiliates as of the
Effective Date in the Licensed Field.

 

1.17.             Existing Genetronics Patent Rights.  “Existing Genetronics Patent Rights” shall
mean any Genetronics Patent Rights Controlled by Genetronics or its Affiliates
as of the Effective Date.

 

1.18.             Existing Genetronics Patents.  “Existing Genetronics Patents” shall mean the
patents and patent applications listed on Schedule 1.18 attached hereto.

 

1.19.             FDA. 
“FDA” shall mean the United States Food and Drug Administration or any
successor agency thereto.

 

1.20.             FD&C Act.  “FD&C Act” shall mean the United States
Federal Food, Drug, and Cosmetic Act, as amended from time to time, and the rules and
regulations promulgated thereunder.

 

1.21.             First Commercial Sale.  “First Commercial Sale” shall mean, with
respect to any Licensed Product and with respect to any country of the
Territory, the first sale of such Licensed Product to a Third Party in such
country after such Licensed Product has been granted Regulatory Marketing
Authorization by a competent Regulatory Authority for such country.

 

1.22.             FTE. 
“FTE” shall mean a full time equivalent scientific person year,
consisting of a minimum of a total of one thousand eight hundred (1800) hours
per year of scientific work by an appropriately educated, qualified and
experienced employee of Genetronics or VGX directly related to activities under
the Agreement.

 

1.23.             GAAP. 
“GAAP” shall mean United States generally accepted accounting principles
consistently applied.

 

1.24.             Genetic Construct.  “Genetic Construct” shall mean any
pharmaceutical or biologic preparation comprising a nucleic acid sequence
encoding a peptide or protein, including, but not limited to, antigen(s),
adjuvant(s), expression vectors, and/or formulations that VGX Develops,
Manufactures, or Commercializes in the Licensed Field.

 

1.25.             Generator. 
“Generator” shall mean an intratumoral EP device, including any software
that is not custom designed for use with a Genetic Construct, for which the
manufacture and/or use with a Genetic Construct in the Licensed Field would
infringe the Genetronics Patent Rights or utilize the Genetronics Licensed
Technology, including but not limited to pulse generation equipment.

 

4

 

1.26.             Genetronics Competitor.  “Genetronics Competitor” means any company
(other than Genetronics or VGX) that is either (i) significantly engaged
in the manufacturing, commercialization, and/or marketing of EP Applicators
and/or Generators or (ii) is a Sublicensee of Genetronics or its parent
company.

 

1.27.             Genetronics Costs.  “Genetronics Costs” means all fully burdened
FTE costs incurred by Genetronics that are related to the performance by
Genetronics of its assigned activities under this agreement that have been
approved in writing in advance by VGX.

 

1.28.             Genetronics Product Enhancements.  “Genetronics Product Enhancements” shall mean
any Genetronics Patent Rights or Genetronics Know-How Controlled by Genetronics
or its Affiliates developed or obtained by Genetronics during the Term that
enhances or technically improves a Licensed Product.

 

1.29.             Genetronics EP Technology.  “Genetronics EP Technology” shall mean
Genetronics’s intratumoral EP delivery technology related to the Licensed
Field, including but not limited to Devices and any other electroporation
equipment, designs thereof, and methods of use thereof.

 

1.30.             Genetronics Know-How.  “Genetronics Know-How” shall mean all
EP-related Know-How Controlled by Genetronics or its Affiliates, now or at any
time during the Term, necessary for the Development, Manufacture, use, sale or
importation of any Licensed Product in a Licensed Field and in the Territory
(other than Genetronics’s interest in Joint IP).

 

1.31.             Genetronics Licensed Technology.  “Genetronics Licensed Technology” shall mean
Genetronics’s rights in (i) Existing EP Intellectual Property, (ii) Genetronics’s
interest in Genetronics Product Enhancements, and (iii) any other
Genetronics Patent Rights and Genetronics Know-How (other than Genetronics’s
interest in Joint IP) related to the Licensed Products in the Licensed Field
and in the Territory.

 

1.32.             Genetronics Patent Rights.  “Genetronics Patent Rights” shall mean any
EP-related Patent Rights Controlled by Genetronics or its Affiliates now or at
any time during the Term, which would be infringed by the Development,
Manufacture, use, sale or importation of any Licensed Product in the Licensed
Field in the Territory (other than Genetronics’s interest in Joint IP).  Genetronics Patent Rights shall include
Genetronics Existing Patent Rights.

 

1.33.             Genetronics Third Party Agreement.  “Genetronics Third Party Agreement” shall
mean any agreement between Genetronics and any Third Party that involves a
license by such Third Party to Genetronics that comprises Genetronics Licensed
Technology.

 

1.34.             IND. 
“IND” shall mean an Investigational New Drug Application, as defined in
the FD&C Act, that is required to be filed with the FDA before beginning
clinical testing in human subjects, or an equivalent foreign filing.

 

5

 

1.35.             Indication. 
“Indication” means, with respect to any Licensed Product, any indication
for such Licensed Product in the Licensed Field for which Regulatory Marketing
Authorization has been achieved or is being sought.

 

1.36.             Joint IP. 
“Joint IP” shall mean the Joint Know-How and the Joint Patent Rights.

 

1.37.             Joint Know-How.  “Joint Know-How” shall mean any Know-How
covering or embodied by or in any Joint Collaboration Technology.

 

1.38.             Joint Patent Right.  “Joint Patent Right” means any Patent Right
covering any Joint Collaboration Technology.

 

1.39.             Joint Collaboration Technology.  “Joint Collaboration Technology” shall mean
any invention, development or discovery, whether or not patentable, made or
created jointly by (i) employees or agents of Genetronics or any of its
Affiliates, and (ii) employees or agents of VGX or any of its Affiliates in the course of carrying out this
Agreement.

 

1.40.             Know-How. 
“Know-How” shall mean any confidential unpatented or unpatentable
technology, compound, cell line or other biological material, probe, sequence,
technical information, method, or other confidential information or material,
in all cases to the extent, but only to the extent, not in the public domain.

 

1.41.             Licensed Field.  “Licensed Field” shall mean the delivery of
HIV vpr gene sequences via DNA intratumoral electroporation at voltages greater
than 800V/cm and less than 2000 V/cm to treat cancer in humans.

 

1.42.             Licensed Product.  “Licensed Product” shall mean any product
where Therapeutic Genetic Constructs are used together with the Devices in
administering treatments to patients in the Licensed Field.

 

1.43.             Major Market Country.  “Major Market Country” shall mean the United
States, France, Germany, the United Kingdom, and Italy.

 

1.44.             Manufacture.  “Manufacture,” “Manufactured” or “Manufacturing”
means all activities involved in the production, packaging and labeling of a
Licensed Product to be Developed and/or Commercialized under this
Agreement.  “Manufacturing” does not
include Development or Commercialization.

 

1.45.             Marketing Application.  “Marketing Application” means a new drug
application or product license application or its equivalent filed with and
accepted by the FDA after completion of human clinical trials to obtain
marketing approval for a Licensed Product, or any comparable application filed
with and accepted by the Regulatory Authority of a country other than the
United States, including, where applicable, any applications for governmental
pricing and marketing approval.

 

1.46.             Net Sales. 
“Net Sales” shall mean the gross amount invoiced for any sale of any
Licensed Product by VGX, any VGX Affiliate or any VGX Sublicensee, as
appropriate (a “Selling Person”), to a non-Affiliate in a bona fide arm’s
length transaction, less the 

 

6

 

following deductions, in each case to the extent specifically related
to the Licensed Product and taken by the Selling Person or otherwise paid for
or accrued by the Selling Person (“Permitted Deductions”):

 

(i)                  trade,
cash, promotional and quantity discounts and wholesaler fees;

 

(ii)                 taxes
on sales (such as excise, sales or use taxes or value added taxes) to the
extent imposed upon and paid directly with respect to the sales price (and
excluding national, sales or local taxes based on income);

 

(iii)                freight,
insurance, packing costs and other transportation charges to the extent
included in the invoice price to the buyer;

 

(iv)               amounts
repaid or credits taken by reason of damaged goods, rejections, defects,
expired dating, recalls, returns or because of retroactive price reductions;

 

(v)                charge
back payments and rebates granted to (a) managed healthcare organizations,
(b) federal, state and/or provincial and/or local governments or other
agencies, (c) purchasers and reimbursers, or (d) trade customers,
including wholesalers and chain and pharmacy buying groups; and

 

(vi)               documented
custom duties actually paid by the Selling Person.

 

1.47.             Patent Rights.  “Patent
Rights” shall mean any and all (a) U.S. or foreign patents, (b) U.S.
or foreign patent applications, including, without limitation, all provisional
applications, substitutions, continuations, continuations-in-part, divisions,
renewals, and all patents granted thereon, (c) all U.S. or foreign
patents-of-addition, reissues, reexaminations and extensions or restorations by
existing or future extension or restoration mechanisms, including, without
limitation, patent term adjustments, patent term extensions, supplementary
protection certificates or the equivalent thereof, and (d) any other form
of government-issued right substantially similar to any of the foregoing.

 

1.48.             Person.  “Person”
shall mean any individual or legal entity.

 

1.49.             Phase I Clinical Trial.  “Phase I Clinical Trial” shall mean a human
Clinical Trial conducted on sufficient numbers of healthy human volunteers with
the endpoint of determining initial tolerance, safety and/or pharmacokinetic
information in single dose, single ascending dose, multiple dose and/or
multiple ascending dose regimens, and to support its continued testing in Phase
II Clinical Trials.

 

1.50.             Phase II Clinical Trial.  “Phase II Clinical Trial” shall mean a human
Clinical Trial that is designed to determine initial efficacy and dose range
findings and to define warnings, precautions and adverse reactions that may be
associated with the product in such dosage range.

 

1.51.             Phase III Clinical Trial.  “Phase III Clinical Trial” shall mean a human
Clinical Trial that is designed to establish that a treatment is safe and
efficacious for its intended use, and to define warnings, precautions and
adverse reactions that are associated with the 

 

7

 

product in the dosage range to be prescribed, and to support Regulatory
Approval of such treatment or label expansion of such medicinal product.

 

1.52.             Product Data.  “Product Data” shall mean all pre-clinical
data and results, clinical protocols, studies, clinical data and results,
post-marketing data and results, manufacturing data and results, and other
information necessary or useful for obtaining Regulatory Approval of a Licensed
Product in the Licensed Field.

 

1.53.             Promotion. 
“Promotion” shall mean those activities, including, without limitation,
detailing and distributing Samples of Licensed Product, normally undertaken by
a pharmaceutical company’s sales force to implement marketing plans and
strategies aimed at encouraging the approved use of a particular Licensed
Product.  When used as a verb, “Promote”
means to engage in such activities.

 

1.54.             Recall. 
“Recall” shall mean, with respect to any pharmaceutical product, a “recall”
or a “product withdrawal” or a “stock recovery” or any similar term as utilized
by any Regulatory Authority under such Regulatory Authority’s procedures
regarding the recall of pharmaceutical products, as the same may be amended
from time to time, and shall include any post-sale warning or mailing of
information regarding such product, including any warnings or mailings
described in the Regulatory Authority’s product recall procedures.

 

1.55.             Registrational Filing.  “Registrational Filing” shall mean an application
submitted to the appropriate Regulatory Authority seeking a Regulatory
Marketing Authorization.

 

1.56.             Regulatory Approval.  “Regulatory Approval” means any technical,
medical, scientific or other license, registration, authorization or approval
of any Regulatory Authority regarding the research, development, clinical
testing, commercial manufacture, distribution, marketing, pricing,
reimbursement, Promotion, offer for sale, use, import, export or sale of any
pharmaceutical product, proposed pharmaceutical product, medical device,
proposed medical device, or any combination thereof.

 

1.57.             Regulatory Authority.  “Regulatory Authority” shall mean, with
respect to a country in the Territory, any national (e.g., the FDA),
supra-national (e.g., the European Commission, the Council of the European
Union, or the European Agency for the Evaluation of Medicinal Products),
regional, state or local regulatory agency, department, bureau, commission,
council or other governmental entity involved in the granting of a Regulatory
Approval for such country or countries.

 

1.58.             Regulatory Marketing Authorization.  “Regulatory Marketing Authorization” shall
mean, with respect to any Licensed Product in any country or region and in any
indication, Regulatory Approval authorizing the marketing of such Licensed
Product in such country or region for such indication.

 

1.59.             Right of Reference.  “Right of Reference” shall mean the right to
reference, cross-reference, review, have access to, incorporate and use in any
regulatory applications or filings, any patent filings, or for any research,
development or commercialization purpose.

 

8

 

1.60.             Samples. 
“Samples” means a unit of Licensed Product that is not intended to be
sold and is intended to Promote the sale of such Licensed Product.  When used as a verb “Sample” means to provide
Samples to healthcare providers.

 

1.61.             Sublicense. 
When used as a verb, “Sublicense” shall mean to, directly or indirectly,
sublicense, or grant any other right with respect to, or agree not to assert,
any intellectual property right granted to a Party under this Agreement.  When used as a noun, “Sublicense” shall mean
any agreement to Sublicense.

 

1.62.             Sublicensee.  “Sublicensee” shall mean any VGX Sublicensee or any Genetronics Sublicensee.

 

1.63.             Term. 
“Term” shall mean the period of time from the Effective Date until the
expiration or earlier termination of this Agreement.

 

1.64.             Territory. 
“Territory” shall mean worldwide.

 

1.65.             Third Party.  “Third Party” shall mean any Person other
than VGX, Genetronics or their respective
Affiliates.

 

1.66.             Trademark. 
“Trademark” shall mean any trademark used by the Parties in connection
with a Licensed Product, other than the Parties’ trade names and trademarks
used by the Parties to identify their companies generally.

 

1.67.             Valid Claim.  “Valid Claim” shall mean a claim of an issued
and unexpired Patent Right that has not been held permanently revoked,
unenforceable or invalid by a decision of a court or other governmental agency
of competent jurisdiction, unappealed or unappealable within the time allowed
for appeal, and that has not been admitted to be invalid or unenforceable
through reissue, disclaimer or otherwise.

 

1.68.             VGX Device Improvements.  “VGX Device Improvements” shall mean any
invention, development or discovery, whether or not patentable, related solely
to Devices and not related to any other subject matter (including, without
limitation, Genetic Constructs) made solely by VGX or jointly by VGX and
Genetronics and arising under this Agreement.

 

1.69.             VGX Know-How.  “VGX Know-How” shall mean all Know-How
Controlled by VGX or its Affiliates, now or at any time during the term of this
Agreement that relates to the Genetic Construct or to the use of the Genetic
Construct in connection with the Development, Manufacture, or Commercialization
of any Licensed Product.

 

1.70.             VGX Licensed Technology.  “VGX Licensed Technology” shall mean the VGX
Patent Rights and VGX Know-How (other than VGX’s interest in Joint IP).

 

1.71.             VGX Patent Rights.  “VGX Patent Rights” shall mean any Patent
Right (other than a Genetronics Patent Right) Controlled by VGX or its
Affiliates, now or at any time during the term of this Agreement, that relate
to the Genetic Construct or to the use of the 

 

9

 

Genetic Construct in connection with the Development, Manufacture, or
Commercialization of any Licensed Product.

 

1.72.             VGX Product Data.  “VGX Product Data” shall mean all Product
Data Controlled by VGX or its Affiliates at any time during the term of this
Agreement.

 

1.73.             VGX Regulatory Approvals.  “VGX Regulatory Approvals” means those
Regulatory Approvals Controlled by VGX or its Affiliates related to the
Development or Commercialization of a Licensed Product.

 

1.74.             VGX Sublicensee.  “VGX Sublicensee” shall mean any Person to
whom VGX has granted, directly or indirectly, any Sublicense of any right
granted to VGX by Genetronics under this Agreement.

 

2.             LICENSE GRANTS.

 

2.1.               Licenses to VGX.

 

2.1.1.          Non-Exclusive License
from Genetronics to VGX. 
Subject to the terms and conditions of this Agreement, Genetronics
hereby grants to VGX and its Affiliates a
non-exclusive license, with the right to grant sublicenses pursuant to Section 2.1.3,
under the Genetronics Licensed Technology to Develop, Manufacture, and
Commercialize Licensed Products in the Licensed Field in the Territory.

 

2.1.2.          Trademark License
from Genetronics to VGX.  Upon VGX’s
written request at any time during the Term and subject to the terms and
conditions of this Agreement, Genetronics shall grant to VGX and its Affiliates a non-exclusive, fully
paid-up, royalty-free, non-transferable Trademark license, with the right to
grant sublicenses, to use Genetronics’s Trademarks and/or trade names in
connection with Genetronics Technology solely to Commercialize and Manufacture
Licensed Products in the Licensed Field in the Territory.  If granted, such Trademark license shall
become perpetual and irrevocable upon expiration of the Term, but shall remain
non-transferable and solely useable by VGX
in connection with Genetronics Technology solely to Manufacture, Commercialize
and Sell Licensed Products in the Licensed Fields in the Territory The
Trademark license will terminate with the Technology License in the event of
early termination.

 

2.1.3.          VGX Sublicenses to Third Parties.  Subject to the payment and other provisions
of Section 6, VGX may, upon written
consent from Genetronics, which consent shall not be unreasonably withheld or
delayed, Sublicense any rights licensed or otherwise granted to VGX under this Agreement to (i) VGX’s Affiliates; (ii) VGX’s distributors of Licensed Products pursuant to
bona fide arm’s length distribution agreements; and (iii) any Third Party other
than a Genetronics Competitor or sublicensee, in each case that enters into a
bona fide license and/or collaboration agreement with VGX to Develop, Manufacture, or Commercialize Licensed
Products in the Licensed Field in the Territory.  Any Sublicense by VGX shall be subject to the provisions of this
Agreement and may, at Genetronics’ sole discretion, survive termination of the
licenses or other rights granted to VGX under this
Agreement in accordance with Section 

 

10

 

11.2.2(iii) hereof;
provided, however, that in no event shall Genetronics be required to accept any
sublicense on terms less favorable to it than the terms of this Agreement, and
provided, further, that VGX shall remain
legally liable to Genetronics for the performance by each such sublicensee of
its obligations thereunder.

 

2.1.4        VGX Sublicenses from Third Parties.  In the event that any of the rights licensed or
otherwise granted by Genetronics to VGX under this Agreement comprise rights also
licensed or otherwise granted by Genetronics to a Third Party, then neither VGX
nor any VGX Affiliate shall enter into any arrangement with that Third Party
whereby the Third Party would sublicense such rights to VGX or a VGX Affiliate
on terms any different from those contained herein.

 

2.2.               Product Enhancements.

 

2.2.1.          Non-Exclusive License
for Product Enhancements to VGX. 
Subject to the terms and conditions of this Agreement, Genetronics hereby grants to VGX a non-exclusive, fully paid-up, royalty-free, non-sublicensable
license to Genetronics Product Enhancements under the Genetronics Licensed Technology and Genetronics’
interest in the Joint IP solely for use by VGX with Licensed Products in the
Licensed Field in the Territory.

 

2.2.2.          License for VGX Device Improvements.  Subject to the terms and conditions of this
Agreement, VGX hereby grants to
Genetronics an exclusive, fully paid-up, royalty-free, sublicensable license in
the Territory under VGX’s rights in the VGX Device Improvements to Develop,
Commercialize and Manufacture Devices and methods in any field.

 

2.3.               Direct Licenses to Affiliates.  VGX may
at any time request and authorize Genetronics to grant licenses directly to
Affiliates of VGX by giving written
notice designating to whom a direct license is to be granted.  Upon receipt of any such notice, Genetronics
shall enter into and sign a separate direct license agreement with such
designated Affiliate of VGX.  All such direct license agreements shall be
consistent with the terms and conditions of this Agreement, except for such
modifications as may be required by the laws and regulations in the country in
which the direct license will be exercised; provided,
however, that Genetronics shall have no obligation to enter into any
such direct license agreement if the effect of entering into such agreement
(and continuing as a party to this Agreement) would be to increase the level of
obligations owed by or risks assumed by Genetronics, or decrease the
consideration owed to Genetronics, relative to the obligations owed by, risks
assumed by, or consideration owed to Genetronics under this Agreement; and
provided, further, that in no event shall a direct license of rights to a VGX Affiliate relieve VGX of its primary liability to Genetronics for all obligations
(including but not limited to obligations of payment, confidentiality, and
diligence) hereunder In countries where validity of the direct license
agreement requires prior government approval or registration, such direct
license agreement shall not become binding between the parties thereto until
such approval or registration is granted, which approval or registration shall
be obtained by VGX or its Affiliate.

 

2.4.               Right of Reference. 
Genetronics hereby grants to VGX
a Right of Reference to any Product Data, regulatory filings, and Regulatory
Approvals Controlled by Genetronics or its Affiliates that relates to Licensed
Products in the Licensed Field for VGX’s
use in the Development, Manufacture, and Commercialization of Licensed
Products, all to the extent that 

 

11

 

they are directly related to VGX’s obligations under the Agreement.  VGX
hereby grants to Genetronics a Right of Reference to any Product Data,
regulatory filings, and Regulatory Approvals Controlled by VGX or its Affiliates that relates to Licensed
Products in the Licensed Field solely for Genetronics’s use in preparing
regulatory filings related to any Device, required safety reporting to
Regulatory Authorities, and any other internal purposes, all to the extent that
they are directly related to Genetronics’s obligations under the Agreement.

 

2.5.               No Other Rights.  No rights, other than those expressly set
forth in this Agreement, are granted to either Party hereunder, and no additional
rights shall be deemed granted to either Party by implication, estoppel or
otherwise.

 

3.             COORDINATION.

 

3.1.             Development Liaison Representative.   VGX and Genetronics shall designate one of
its representatives to serve as Development Liaison Representative (“DLR”).  Each Party shall be free to change its DLR on
written notice to the other Party.

 

3.2.             Responsibilities of the Development Liaison
Representatives.  The DLR’s
shall be responsible for the coordination of certain activities under the Collaboration,
including

 

(i)         coordinating the supply
of any Device under any Development Agreement along with any activities in
support of obtaining Regulatory Approval in the Licensed Field for such Device;

 

(ii)        providing general
oversight of the entire collaboration between VGX
and Genetronics, including Development and Commercialization of each Licensed
Product and determination of when milestones have been reached with respect to
any Licensed Product;

 

(iii)       fostering the collaborative
relationship between the Parties;

 

(iv)       facilitating all required
technology transfer;

 

(v)        reaching mutual agreement
as to termination of the Agreement due to failure of purpose or science; and

 

(vi)       such other matters as the
Parties may assign to the DLR’s from time to time.

 

4.             PRODUCT DEVELOPMENT AND COMMERCIALIZATION.

 

4.1.             General.  Except as set forth in Section 4.3
(Regulatory Responsibilities), VGX shall be solely responsible for Developing
and Commercializing Licensed Products in the Licensed Field during the Term.

 

4.2.             Diligence.  VGX shall use Commercially
Reasonable Efforts to Develop, Manufacture and Commercialize a Licensed Product
in the Licensed Field in the Major Market Countries.  In the event that VGX does not use
commercially reasonable efforts to develop Licensed Product in the Field by
failing to initiate a clinical study within two (2) years of the 

 

12

 

effective date or failure to initiate a
pivotal Phase III clinical trial within six (6) years of the effective
date, then, unless otherwise agreed by the Parties in writing, the License
Grant shall terminate and all rights granted herein shall revert to
Genetronics.

 

4.3.             Regulatory Responsibilities.  VGX shall have overall responsibility for developing a
registration strategy for each Licensed Product and for coordinating all
regulatory matters under the Collaboration.  
Anything in this Section 4.3 notwithstanding, however, the
Parties expressly agree that under no circumstances shall VGX make any
regulatory filing, seek any Regulatory Approval, or otherwise communicate with
or submit information to any Regulatory Authority regarding any regulatory
filing or Regulatory Approval, in connection with any Device without the prior
review and written approval of Genetronics.

 

4.4.             Regulatory Documentation-Device.  Genetronics shall provide all regulatory
documentation and support related to the Device necessary for VGX to obtain
approval of Licensed Product using such Device and any related enhancements or
technical improvements or changes thereto. 
In the event that VGX requires special documentation, testing or
regulatory support not already existing at Genetronics or that can not be
generated based on the IL-12 study currently carried out at the Moffitt Cancer
Center, VGX shall reimburse Genetronics for the FTE cost associated with
generating such documentation.

 

4.4.1.       Regulatory Filing and Approvals.  VGX shall file, in its own name (or the name of
its designated Affiliate), all applications for any form of Regulatory Approval
in the Licensed Field for each Licensed Product in all countries in the
Territory and shall own all Regulatory Approvals resulting from such
applications.  If VGX determines in
its sole discretion that Regulatory Approval for a Device would be necessary or
useful to the registration strategy for any Licensed Product in the Licensed
Field, upon VGX ‘s written request Genetronics shall prepare and file, in its own
name, applications for Regulatory Approval in the Licensed Field for such
Device.  VGX shall have the
opportunity to review and comment on all such filings prior to submission.  All Regulatory Approvals related to the
device (e.g., CE mark, PMA or 510k) resulting from such applications shall be
the property of Genetronics.  VGX or its
designated Affiliate shall be the named sponsor of any Clinical Trial to be
conducted during Development of the Licensed Products.

 

4.4.2.       Reporting.  VGX shall be responsible for filing all
reports required to be filed in order to maintain any Regulatory Marketing
Authorizations granted for Licensed Products in all countries of the Territory
in the Licensed Field.  VGX shall be
responsible for the adverse experience and safety reporting for all Licensed
Products in compliance with the requirements of the FD&C Act and the
regulations promulgated thereunder and the equivalent regulations in other
countries in the world.  Genetronics
shall cooperate with VGX in preparing and filing all such reports and, upon VGX’s
request, provide VGX with any information in Genetronics’s possession or
Control which VGX reasonably deems to be relevant to any such report.  Genetronics shall be responsible for filing
all reports required to be filed in order to maintain any Regulatory Marketing
Authorizations granted for Devices.  VGX
shall cooperate with Genetronics in preparing and filing all such reports and,
upon Genetronics’ request, provide Genetronics with any information in VGX’s
possession or Control which Genetronics reasonably deems to be relevant to any
such report.

 

13

 

4.4.3.                              Communications with
Regulatory Authorities; Genetronics Assistance.  VGX shall have the primary responsibility for
communicating with any Regulatory Authority regarding any regulatory filing or
any Regulatory Approval related to any Licensed Product prior to submission,
during registration/review by a Regulatory Authority or post approval in the
Territory in the Licensed Field.  At VGX’s
written request, and at VGX’s expense pursuant to Section 5.4.6 below,
Genetronics shall (a) provide VGX with advice and reasonable assistance in
(i) developing a Regulatory Approval filing strategy for Licensed
Products, (ii) reviewing study reports from Clinical Studies of Licensed
Products, (iii) preparing applications for Regulatory Approval for
Licensed Products, (iv) preparing supplements to applications for
Regulatory Approval for Licensed Products, (v) responding to questions
from Regulatory Authorities regarding applications for Regulatory Approval or
any supplement thereto and (b) participate in interactions with Regulatory
Authorities concerning the Licensed Products.

 

4.4.4.                              Product Recalls.  VGX shall be solely responsible for all
contact with Regulatory Authorities relating to any Recall of any Licensed
Product.  VGX shall be solely responsible
for implementing, directing and administering any Recall of any such Licensed
Product required or recommended by any Regulatory Authority or court of
competent jurisdiction, or determined by VGX, in its sole discretion, to be
necessary or advisable.  VGX shall bear the
expense of any such recall except for those cases that are determined to be
caused by Device malfunctions resulting from manufacturing defects.  Gentronics shall bear the expense of a recall
of the Devices that malfunction due to manufacturing defects.

 

4.4.5.                              Inspections.  The Parties shall cooperate in good faith
with respect to the conduct of any inspections by any Regulatory Authority of a
Party’s site and facilities related to Licensed Products.

 

4.4.6.                              Expenses.  VGX shall be responsible for its own expenses
(both internal expenses and out-of-pocket costs paid to a Third Party) incurred
in performing its responsibilities in making any filing or otherwise seeking
any Regulatory Approval for the Licensed Products in the Licensed Field or in
responding to any Regulatory Authority including post approval
commitments.  VGX shall reimburse
Genetronics for its fully burdened FTE costs in performing its regulatory
activities pursuant to Sections 4.4.1 and 4.4.3 including but not limited to
reimbursement for FTE’s actually employed by Genetronics in such activities, as
agreed in advance by VGX, at a rate of **** per FTE; provided,
however, that such regulatory activities were approved in writing by
VGX prior to being performed by Genetronics.

 

4.5.                                              Commercialization Responsibilities.

 

4.5.1.                              General. 
VGX shall have sole responsibility and exclusive control over all matters
relating to the Commercialization of Licensed Products.  Without limiting the generality of the
foregoing, VGX (or its designated Affiliates) shall:

 

(i)                           be the exclusive distributor for Licensed Products in
the Territory for its own account and risk;

 

14

 

(ii)                        be
responsible for invoicing and booking sales for, warehousing, and distributing
all Licensed Products in the Territory and shall perform related distribution
activities; and

 

(iii)                     have the right and responsibility for establishing
and modifying the terms and conditions with respect to the sale of Licensed
Products (including any Device sold as a part of a Licensed Product) in the
Territory, including any terms and conditions relating to or affecting the
price at which Licensed Products will be sold; discounts available to managed
care providers; any discount attributable to payments on receivables; any
conditions of local reimbursement; distribution of Licensed Products; and
credits, price adjustments, other discounts, and allowances to be granted or
refused.

 

5.                                       MANUFACTURING AND SUPPLY.

 

5.1.                                              General. 
Except as set forth in Section 5.4, VGX
(or its designated Affiliates or Third Parties) shall be responsible for the
Manufacture and supply of Genetic Constructs and Licensed Products in the
Licensed Field in the Territory.

 

5.2.                                              Diligence. 
Genetronics shall use Commercially Reasonable Efforts to fulfill its
obligations under any Clinical Supply Agreement and the Commercial Supply
Agreement.

 

5.3.                                              Genetic Construct Manufacture.  VGX
shall have sole responsibility and exclusive control over all matters relating
to the Manufacture of Genetic Constructs for Licensed Products.  Without limiting the foregoing, VGX may contract with its Affiliates or Third
Parties of its sole choice to perform any or all of the activities relating to
the Manufacture of such Genetic Constructs.

 

5.4.                                              Device Manufacture.  Subject to execution of a Clinical Supply
Agreement and Commercial Supply Agreements as set forth below, Genetronics
shall be responsible for the Manufacture and supply of the quantities of each
Device needed for Development and Commercialization of Licensed Products in the
Field in the Territory as described below.

 

5.4.1.                              Clinical Supply.  For all clinical trials required to obtain
regulatory approval of Licensed Product, Genetronics will supply
electroporation applicators and generators and any technical advancements
thereto, to VGX at the price indicated in Schedule 5.4.1.

 

5.4.2.                              Commercial Supply.  Upon reaching commercial level production
volumes of its electroproation-assisted DNA delivery devices, Genetronics will
enter good faith negotiations with regard to the per unit price to VGX, such
per unit price to be established at commercially reasonable terms.

 

6.                                       CONSIDERATION.

 

6.1.                              Upfront Payment.  Within thirty (30) days of the Effective
Date, VGX shall pay to Genetronics the sum indicated in Schedule 6.1.

 

6.2.                              Development Payments.  In partial consideration for Genetronics’s
development of the Genetronics Technology and performance of Genetronics’s
obligations under this 

 

15

 

Agreement, VGX shall pay to
Genetronics the amounts set forth in Schedule 6.2  (each, a “Development Payment”) within
thirty (30) days of the first occurrence of each event described below for any
Licensed Product in the Licensed Field (each, a “Development Event”).  A Licensed Product shall be considered to
have “entered” a Clinical Trial when, following all applicable Regulatory
Approvals, the Licensed Product is first administered to a subject enrolled in
such Clinical Trial.

 

For the avoidance of doubt, in the event that
a Licensed Product bypasses an earlier Development Event and achieves a later
Development Event, then upon achievement of the later Development Event,
Development Payments shall be made at that time both for the Development Event
achieved and any earlier Development Events bypassed.

 

6.2.1.                              Each of the Development
Payments above shall be payable when the Development Event is achieved and
shall be due in its entirety regardless of the number or configuration of the
studies.

 

6.2.2.                              If one or more subsequent
Licensed Product candidates replaces the first or subsequent Licensed Product
candidate in Development, such replacement Licensed Product candidate(s) shall
only be subject to those Development Payments that have not previously been
achieved by the replaced Licensed Product candidate(s).

 

6.3.                                              Royalty Payments.

 

6.3.1.                              Patent Royalty Period.   The Patent Royalty Period will be, with
respect to any particular Licensed Product in any country, the period of time
beginning on the First Commercial Sale of such Licensed Product in such country
and extending until the earlier of (i) the date when there is not any
Valid Claim included in any Genetronics Patent Right in any country which would
be infringed by the sale of the Licensed Product in any country but for a
license granted by Genetronics to VGX hereunder, or (ii) ten (10) years
from the date of First Commercial Sale of such Licensed Product in such
country.  Thereafter, no further
royalties shall be payable in respect of sales of such Licensed Product in such
country and, thereafter, the license granted to VGX under Section 2.1 with
respect to such Licensed Product in such country shall become fully paid-up,
perpetual, irrevocable, non-exclusive, royalty-free licenses.

 

6.3.2.                              Royalties.  VGX, on a Licensed Product-by-Licensed
Product and country-by-country basis, shall pay to Genetronics royalties in the
amount of the Applicable Net Sales Percentage of the Net Sales obtained by VGX,
its Affiliates or VGX Sublicensees from the sale of each Licensed Product in
the Licensed Fields in the Territory in any Calendar Year during the Patent
Royalty Period, as set forth in Schedule 6.3.2.

 

6.3.3.                                      Royalty
Adjustments.  The following
adjustments shall be made, on a Licensed Product-by-Licensed Product and
country-by-country basis, to the royalties payable pursuant to Section 6.3.1
hereof.

 

No Patent Coverage.  In the case of any Net Sales of any Licensed
Product in the Licensed Fields in any country where such Licensed Product is
not covered by an issued Valid Claim of the Genetronics Licensed Technology,
the royalty payable by VGX to Genetronics on such Net Sales shall be reduced to
**** of the amount that would 

 

16

 

otherwise have been payable during the Patent
Royalty Period with respect to such Net Sales pursuant to Section 6.3.1.

 

6.4.                                              Reports and Payments.

 

6.4.1.                              Cumulative Royalties.  The obligation to pay royalties under this
Agreement shall be imposed only once with respect to any sale of any Licensed
Product.

 

6.4.2.                              Royalty Statements and
Payments.  Within sixty (60) days of
the end of each Calendar Quarter, VGX shall deliver to Genetronics a report
setting forth for such Calendar Quarter, the following information, on a
Licensed Product-by-Licensed Product, country-by-country and worldwide basis: (a) the
Net Sales of each Licensed Product, (b) the basis for any adjustments to
the royalty payable for the sale of any such Licensed Product, and (c) the
royalty due hereunder for the sale of each such Licensed Product.  No such reports shall be due for any such
Licensed Product before the First Commercial Sale of such Licensed
Product.  The total royalty due for the
sale of all such Licensed Products during such Calendar Quarter shall be
remitted at the time such report is made.

 

6.4.3.                              Taxes and Withholding.  All payments under this Agreement will be
made without any deduction or withholding for or on account of any tax, duties,
levies, or other charges unless such deduction or withholding is required by
applicable laws or regulations to be assessed against Genetronics.  If VGX is so required to deduct or withhold,
VGX will (i) promptly notify Genetronics of such requirement, (ii) pay
to the relevant authorities the minimum amount actually required by law or
treaty to be deducted or withheld promptly upon the earlier of determining that
such deduction or withholding is required or receiving notice that such amount
has been assessed against Genetronics, and (iii) promptly forward to
Genetronics an official receipt (or certified copy) or other documentation
reasonably acceptable to Genetronics evidencing such payment to such
authorities.

 

6.4.4.                              Currency.  All amounts payable and calculations
hereunder shall be in United States dollars. 
As applicable, Net Sales and any royalty deductions shall be translated
into United States dollars at the exchange rate used by VGX for public
financial accounting purposes in accordance with generally accepted accounting
principles.  If, due to restrictions or
prohibitions imposed by national or international authority, payments cannot be
made as provided in this Section 6.4.4, then VGX shall nonetheless remain
fully liable to Genetronics for payment hereunder.

 

6.4.5.                              Record Keeping.  VGX shall keep and shall cause its Affiliates
and Sublicensees to keep books and accounts of record in connection with the
sale of Licensed Products, in accordance with GAAP and in sufficient detail to
permit accurate determination of all figures necessary for verification of
royalties to be paid hereunder.  VGX and
its Affiliates shall maintain such records for a period of at least three (3) years
after the end of the Calendar Quarter in which they were generated, provided,
however, that if any records are in dispute and VGX has received written notice
from Genetronics of the records which are in dispute, VGX shall keep such
records until the dispute is resolved.

 

17

 

6.4.6.                              Audits.  Upon thirty (30) days prior written notice
from Genetronics, VGX shall permit an independent certified public accounting
firm of nationally recognized standing selected by Genetronics and reasonably
acceptable to VGX, to examine, at Genetronics’s sole expense, the relevant
books and records of VGX and its Affiliates as may be reasonably necessary to
verify the amounts reported by VGX in accordance with Section 6.4.2 and
the payment of royalties hereunder.  An
examination by Genetronics under this Section 6.4.6 shall occur not more
than once in any Calendar Year and shall be limited to the pertinent books and
records for any Calendar Year ending not more than three (3) years before
the date of the request.  The accounting
firm shall be provided access to such books and records at VGX’s facility(ies)
where such books and records are normally kept and such examination shall be
conducted during VGX’s normal business hours. 
VGX may require the accounting firm to sign a standard non-disclosure
agreement before providing the accounting firm access to VGX’s facilities or
records.  Upon completion of the audit,
the accounting firm shall provide both VGX and Genetronics a written report
disclosing any discrepancies in the reports submitted by VGX or the royalties
paid, and, in each case, the specific details concerning any discrepancies.  No other information shall be provided to
Genetronics.

 

6.4.7.                              Underpayments/Overpayments.  If such accounting firm correctly concludes
that additional royalties were due to Genetronics, VGX shall pay to Genetronics
the additional royalties within forty-five (45) days of the date VGX receives
such accountant’s written report. 
Notwithstanding any other provision in this Section 6.4 to the
contrary, if such underpayment exceeds three percent (3%) of the royalties that
were to be paid to Genetronics, VGX also shall reimburse Genetronics for the
out-of-pocket expenses incurred in conducting the audit.  Neither Genetronics nor VGX shall reveal to
such accounting firm the conditions under which the audit expenses are to be
reimbursed hereunder.  If such accounting
firm correctly concludes that VGX over paid royalties to Genetronics,
Genetronics will refund such overpayments to VGX, within forty-five (45) days
of the date Genetronics receives such accountant’s report.

 

6.4.8.                              Confidentiality.  All reports and financial information of VGX
which is subject to review under this Section 6 shall be deemed to be VGX’s
Confidential Information subject to the provisions of Section 7.1 hereof,
and Genetronics shall not disclose such Confidential Information to any Third
Party or use such Confidential Information for any purpose other than verifying
payments to be made by VGX to Genetronics hereunder; provided, however, that
such Confidential Information may be disclosed by Genetronics to Third Parties
only to the extent necessary to enforce Genetronics’s rights under this
Agreement.

 

6.4.9.                              Disclaimer.  Genetronics acknowledges and agrees that
nothing in this Agreement (including any exhibits or attachments hereto) shall
be construed as representing an estimate or projection of either (a) the
number of Licensed Products that will or may be successfully Developed or
Commercialized or (b) anticipated sales or the actual value of any
Licensed Product.  The foregoing
disclaimer shall not mitigate VGX’s obligation to use Commercially Reasonable
due diligence to develop the Licensed Products in the Licensed Field.

 

18

 

7.                                       MUTUAL COVENANTS.

 

7.1.                                              Confidentiality.

 

7.1.1.                              Confidentiality.  During the term of this Agreement and for a
period of five years following the expiration or earlier termination thereof,
each Party shall maintain in confidence the Confidential Information of the
other Party, and shall not disclose, use or grant to a Third Party the right to
use any of the Confidential Information of the other Party except on a
need-to-know basis to such Party’s directors, officers and employees, and to
such Party’s consultants working on such Party’s premises, to the extent such
disclosure is reasonably necessary in connection with such Party’s activities
as expressly authorized by this Agreement. 
To the extent that disclosure to any person is authorized by this
Agreement, prior to disclosure, a Party shall obtain written agreement of such
person to hold in confidence and not disclose, use or grant the use of the
Confidential Information of the other Party except as expressly permitted under
this Agreement.  Each Party shall notify
the other Party promptly upon discovery of any unauthorized use or disclosure
of the other Party’s Confidential Information.

 

7.1.2.                              Terms
of Agreement.  Neither Party shall
disclose any terms or conditions of this Agreement to any Third Party without
the prior written consent of the other Party; provided, however, that a Party
may disclose the terms or conditions of this Agreement, (a) on a
need-to-know basis to its legal and financial advisors, who are obligated to
maintain such information in confidence, and (b) to a Third Party (who is
obligated to maintain such information in confidence) in connection with (i) an
equity investment in Genetronics by such Third Party (so long as such
investment is not by a pharmaceutical company the market capitalization of
which makes it a competitor of VGX), (ii) a
merger, consolidation or similar transaction by such Party, or (iii) the
sale of all or substantially all of the assets of such Party relating to the
subject matter of this Agreement. 
Notwithstanding the foregoing, prior to execution of this Agreement, the
Parties have agreed upon the substance of information that can be used to
describe the terms and conditions of this transaction, and each Party may
disclose such information, as modified by mutual written agreement of the
Parties, without the consent of the other Party.

 

7.1.3.                              Permitted
Disclosures.  The confidentiality
obligations under this Section 7 shall not apply (a) to the extent
that a Party is required to disclose information by applicable law, regulation
or order of a governmental agency or a court of competent jurisdiction, or (b) to
the extent necessary or desirable to allow either Party (where possible, with
adequate safeguards for confidentiality) to defend against litigation or to
file and prosecute patent applications; provided, however, in either such case
that such Party shall provide written notice thereof to the other Party,
consult with the other Party with respect to such disclosure and provide the
other Party sufficient opportunity to object to any such disclosure or to
request that the disclosing Party seek confidential treatment thereof, in which
event, the disclosing Party shall use all reasonable efforts to accommodate the
other Party’s requests.

 

7.1.4.                              Announcements.  Except as may be expressly permitted under Section 7.1.3,
neither Party will make any public announcement regarding this Agreement
without the prior written approval of the other Party.  For the sake of clarity, nothing in this
Agreement shall prevent VGX from making
any scientific publication or public announcement concerning VGX’s Commercialization activities with respect
to any Licensed Product under this Agreement; provided, however, that VGX shall not disclose any of Genetronics’s
Confidential Information in any such publication or announcement without
obtaining Genetronics’s prior written consent to do so.  The Parties expressly agree that both parties
may release a press release upon the execution of this Agreement subject to each other’s prior review and written approval.

 

19

 

7.1.5.                              Publications.  During the term of this Agreement, each Party
shall submit to the other Party for review and approval all proposed academic,
scientific, and medical publications and public presentations relating to the
Licensed Product for review in connection with preservation of Patent Rights
and/or to determine whether Confidential Information of the other Party should
be modified or deleted, provided, however that after the approval of an
academic, scientific or medical publication and/or public presentation has been
given, then such Party shall not have to resubmit any such information for
re-approval should it be republished or publicly disclosed in another
form.  The parties agree not to
unreasonably withhold such consent. Written copies of such proposed publications
and presentations shall be submitted to the other Party no later than 60 days
before submission for publication or presentation and such other Party shall
provide its comments with respect to such publications and presentations within
30 days following its receipt of such written copy; provided, however, that if
it is determined by the reviewing Party that publication or presentation would
jeopardize the intellectual property rights of such Party, then publication or
presentation will be delayed for a period of time reasonably sufficient to
allow the reviewing Party to apply for patent protection with respect to such
intellectual property.  Genetronics and VGX shall each comply with standard academic
practice regarding authorship of scientific publications and recognition of
contribution of other parties in any publications relating to the development
of the Licensed Products.

 

7.2.                                              Compliance with Law.  Each Party here covenants and agrees to
comply with all laws and regulations applicable to its activities connected
with the Development, Manufacture and Commercialization (as applicable) of
Licensed Products.  Without limiting the
generality of the foregoing:

 

7.2.1.                              Patient
Information.  Each Party agrees to
abide by all laws, rules, regulations, and orders of all applicable supranational,
national, federal, state, provincial, and local governmental entities
concerning the confidentiality or protection of patient identifiable
information and/or patients’ protected health information, as defined by U.S.
C.F.R. Part 160 or personal data as defined by EU Directive 95/46/EC or
any other applicable legislation, in the course of their performance under this
Agreement.

 

7.2.2.                              Export
Controls.  This Agreement is made
subject to any restrictions concerning the export of products or technical information
from the United States or other countries which may be imposed upon or related
to VGX or Genetronics from time to
time.  Each Party agrees that it shall
not export, directly or indirectly, any technical information acquired from the
other Party under the Agreement or any products using such technical
information to a location or in a manner that at the time of export requires an
export license or other governmental approval, without first obtaining the
written consent to do so from the appropriate agency or other governmental
entity.

 

7.2.3.                              Debarment.  Each Party agrees that it shall not use, in
any capacity, in connection with any of its obligations to be performed under
the Agreement any individual who has been debarred under the FD&C Act or
the Generic Drug Enforcement Act.

 

20

 

8.                                       REPRESENTATIONS AND WARRANTIES.

 

8.1.                                              Representations and Warranties of Each Party.  As of the Effective Date, each of Genetronics
and VGX hereby represents and warrants to
the other Party hereto as follows:

 

(a)                                  it is a corporation
or entity duly organized and validly existing under the laws of the state or
other jurisdiction of its incorporation or formation;

 

(b)                                 the execution,
delivery and performance of this Agreement by such Party has been duly
authorized by all requisite corporate action and does not require any
shareholder action or approval;

 

(c)                                  it has the power and
authority to execute and deliver this Agreement and to perform its obligations
hereunder;

 

(d)                                 the execution,
delivery and performance by such Party of this Agreement and its compliance
with the terms and provisions does not and shall not conflict with or result in
a breach of any of the terms and provisions of or constitute a default under (i) a
loan agreement, guaranty, financing agreement, agreement affecting a product or
other agreement or instrument binding or affecting it or its property; (ii) the
provisions of its charter or operative documents or bylaws; or (iii) any
order, writ, injunction or decree of any court or governmental authority
entered against it or by which any of its property is bound; and

 

(e)                                  it has the full
right, power and authority to grant all of the right, title and interest in the
licenses granted to the other Party under this Agreement.

 

8.2.                                              Additional Representations and Warranties of
Genetronics.  Genetronics
hereby represents, warrants, and covenants to VGX
that:

 

(a)                                  it has the full
right, power and authority to grant all of the right, title and interest in the
licenses in Existing Genetronics Patents granted to VGX under this Agreement;

 

(b)                                 except as provided in
the Genetronics Third Party Agreements, Genetronics is the owner of or
otherwise Controls the Existing Genetronics Patents, all of which are free and
clear of any liens, charges and encumbrances;

 

(c)                                  as of the Effective
Date, there are no claims, judgments or settlements against or owed by
Genetronics or, to the best of its knowledge, pending claims or litigation, in
either case relating to the Existing Genetronics Patents.

 

8.3.                                              Representation by Legal Counsel.  Each Party hereto represents that it has been
represented by legal counsel in connection with this Agreement and acknowledges
that it has participated in the drafting. 
In interpreting and applying the terms and provisions of this Agreement,
the Parties agree that no presumption shall exist or be implied against the
Party which drafted such terms and provisions.

 

21

 

8.4.                                              Disclaimer. 
THE FOREGOING WARRANTIES OF EACH PARTY ARE IN LIEU OF ANY OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED
WARRANTIES OF NONINFRINGEMENT, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR ANY
IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE ALL OF WHICH ARE HEREBY
SPECIFICALLY EXCLUDED AND DISCLAIMED.

 

9.                                       INTELLECTUAL PROPERTY.

 

9.1.                                              Disclosure. 
During the Term, each Party shall promptly disclose to the other Party
all Know-How Controlled by the first Party that is conceived, reduced to
practice, or developed by any employee of the first Party (or its Affiliates),
or by or on behalf of any Third Party retained by the first Party, in the
course of fulfilling such Party’s obligations under the Collaboration (whether
patentable or not) (“Collaboration Know-How”).  Any Patent Rights (“Collaboration Patent
Rights”) derived from such Know-How, together with such Know-How,
constitute “Collaboration Technology”.

 

9.2.                                              Ownership.

 

9.2.1.                              Genetic
Constructs.  Notwithstanding any
other provision of the Agreement, VGX
shall own all interest in and to any Collaboration Technology which constitutes
an improvement, modification, or enhancement to, or further development of, any
Genetic Constructs Controlled by VGX, and
such Collaboration Technology shall be deemed VGX
Collaboration Technology.  Genetronics
shall sign or have its employees and agents sign such documentation as may be
necessary to obtain, perfect or maintain assignment of any such Collaboration
Technology to VGX.

 

9.2.2.                              Collaboration
Technology.  Subject to the license
grants in Section 2, as between the Parties, VGX shall own all Collaboration Know-How (and related Collaboration
Patent Rights) conceived, reduced to practice and developed either (a) solely
by VGX, its Affiliates or any of their
employees or consultants or (b) by VGX,
its Affiliates or any of their employees or consultants together with a third
party or a third party’s employees or consultants (“VGX Collaboration Technology”), and Genetronics shall own
all Collaboration Know-How (and related Collaboration Patent Rights) conceived,
reduced to practice and developed either (a) solely by Genetronics, its
Affiliates or any of their employees or consultants or (b) by Genetronics,
its Affiliates or any of their employees or consultants together with a third
party or a third party’s employees or consultants (“Genetronics
Collaboration Technology”).  All
Collaboration Know-How (and related Collaboration Patent Rights) conceived,
reduced to practice or developed jointly by VGX,
its Affiliates or any of their employees or consultants and by Genetronics, its
Affiliates or any of their employees or consultants (“Joint Collaboration
Technology”) shall be owned jointly by VGX
and Genetronics except as set forth above in Section 9.2.1.

 

9.2.3.                              Non-Collaboration
Technology.  Each Party shall retain
all intellectual property owned or Controlled by such Party that is not
Collaboration Technology, including without limitation, all intellectual
property owned by a Party prior to the Execution Date and all 

 

22

 

intellectual property conceived, reduced to
practice or developed by a Party outside of the scope of this Agreement (“Non-Collaboration
Technology”).

 

9.2.4.                              Rights
of Use to Joint Collaboration Technology.  Subject to the rights granted hereunder,
either Party may use or license its interest in any Joint Collaboration
Technology without accounting to the other Party.

 

9.2.5.                              Inventorship.  Determinations as to which Party has invented
any Patent Right or Know-How shall be made in accordance with the standards of
inventorship and conception under U.S. patent law.

 

9.3.                                              Prosecution and Maintenance of Patent Rights.

 

9.3.1.                              Each
Party’s Own Patent Rights.

 

(i)                           Each
Party shall have the initial right, but not the obligation, to file, prosecute,
and maintain any Patent Right covering intellectual property owned by such
Party, other than any Patent Right covering Joint Collaboration Technology (a “Joint
Patent Right”), and to determine in which countries to do so, in all cases
at its own expense.

 

9.3.2.                              Joint
Patent Rights.  Upon the
identification of Joint Collaboration Know-How, the Parties shall (i) promptly
discuss such Joint Collaboration Know-How, (ii) promptly discuss the
desirability of filing a United States patent application covering such Joint
Collaboration Know-How, as well as any foreign counterparts, and (iii) make
the final decision with respect to any such filings as soon as practicable,
including the allocation of expenses therefore.

 

9.3.3.                              Costs
and Expenses.  Each Party shall bear
the costs and expenses of filing, prosecuting, and maintaining Patent Rights as
provided for in this Section 9.3.

 

9.4.                                              Trademarks.

 

9.4.1.                              Licensed
Product Trademarks.  All Licensed
Products shall be sold in the Territory under Trademarks and trade dress
selected by VGX.  Except with respect to Trademarks licensed by
Genetronics to VGX pursuant to Section 2.1.2,
VGX shall own such Trademarks, trade
dress, domain names and copyrights, along with all goodwill associated therewith,
and shall be responsible for the filing, prosecution and maintenance at its own
expense of such Trademarks, trade dress and copyrights in the Territory.  VGX may
select and use its own Trademarks and trade dress in connection with the
Commercialization of Licensed Products under this Agreement.  Except with respect to Trademarks licensed by
Genetronics to VGX pursuant to Section 2.1.2,
Genetronics shall neither use nor seek to register, anywhere in the world, any
trademarks which are confusingly similar to any Trademarks, trade names, trade
dress or logos used by or on behalf of VGX,
its Affiliates or Sublicensees in connection with any Licensed Product.  Except with respect to Trademarks licensed by
Genetronics to VGX pursuant to Section 2.1.2,
VGX shall neither use nor seek to
register, anywhere in the world, any trademarks which are confusingly similar
to any Trademarks, trade names, trade dress or logos used by or on behalf of
Genetronics, its Affiliates or Sublicensees in connection with any Licensed
Product.

 

23

 

9.4.2.          Costs.  Except with respect to Trademarks licensed by
Genetronics to VGX pursuant to Section 2.1.2,
VGX shall bear the costs of obtaining and
maintaining Trademarks and trade dress used in the Commercialization of
Licensed Products.

 

9.4.3.          Party Names on Product
Promotional Material.  VGX shall have sole control and sole regulatory
responsibility over the packaging and labeling of Licensed Products, but shall
provide for Genetronics to be appropriately identified in accordance with
applicable law on all packaging, labels, packaging inserts and other
promotional materials used in connection with any Licensed Product.

 

9.5.               Enforcement of Technology Rights.

 

9.5.1.          Notice.  If VGX
or Genetronics becomes aware that any VGX
Licensed Technology, Genetronics Licensed Technology or Joint IP is being
infringed or misappropriated by a Third Party in the Licensed Field or is
subject to a declaratory judgment action, nullity action or similar proceedings
arising from such infringement (collectively, an “Infringement”), VGX or Genetronics, as the case may be, shall
promptly notify the other Party thereof in writing reasonably detailing the
Infringement.

 

9.5.2.          Enforcement by Genetronics.

 

(i)         Genetronics
Licensed Technology in the Licensed Field and Joint IP Generally.   Genetronics shall have the first right
(but not the obligation), at its sole expense, to enforce any Genetronics
Licensed Technology in the Licensed Field or Joint IP inside or outside the
Licensed Field against any Infringement; provided, however, that (i) VGX
shall have the right to join such proceeding at any time at its own expense and
shall do so at any time if it is deemed to be a necessary party, and (ii)  however, whether or not joined, VGX shall not
admit the invalidity or unenforceability of any Genetronics Licensed Technology
or Joint IP without Genetronics’s prior written consent.   Genetronics shall keep VGX reasonably
informed prior to and during any such enforcement.  VGX agrees in any event to assist Genetronics, upon Genetronics’ request and at Genetronics’
expense, in taking any action to enforce such Joint IP or Genetronics Licensed
Technology.

 

(ii)        Genetronics
Licensed Technology Outside the Licensed Field.  Genetronics shall have the right (but not the
obligation), at its sole expense, to enforce any Genetronics Licensed
Technology outside the Licensed Field against any Infringement.

 

9.5.3.          Enforcement by VGX.

 

(i)         Genetronics
Licensed Technology in the Licensed Field and Joint IP Generally.  If Genetronics
fails to abate an Infringement of the Genetronics Licensed Technology in the
Licensed Field or Joint IP inside the Licensed Field, or to file an action to
abate such Infringement within six (6) months after a written request from
VGX to do so (or earlier if delay will prejudice Genetronics’s rights to take
action, or if Genetronics discontinues
the prosecution of any such action, VGX at its expense shall have the right, in
its discretion, to undertake such action as it determines appropriate to
enforce such Joint IP or Genetronics Licensed Technology.  VGX shall keep Genetronics reasonably informed on a quarterly basis, in person or
by telephone, prior to and during any such enforcement.  In such case, Genetronics
shall assist VGX, upon VGX’s 

 

24

 

request and at
VGX’s sole expense, in taking any action to enforce such Joint IP or
Genetronics Licensed Technology.

 

9.5.4.          Recoveries.  All monies recovered upon the final judgment
or settlement of any such action described in Section 9.5.2(i) shall
be used first to reimburse the costs and expenses (including reasonable
attorneys’ fees and costs) of Genetronics and VGX.  Thereafter, (a) to the extent that any
final judgment, award or settlement payment is based on or specified as lost
revenues or lost profits from sale of Licensed Products, such award or payment
will be deemed Net Sales, and royalties will be paid pursuant to Section 6.3;
and (b) to the extent that any final judgment or settlement is other than
lost revenues or lost profits from sale of Licensed Products, the parties will
share any such award or payment equally.

 

9.5.5.          No Liability for Unfavorable
Outcome to Litigation.  Neither Party
shall incur any liability to the other Party as a consequence of any litigation
brought as provided above or any unfavorable decision resulting therefrom,
including any decision holding any Patent Right invalid or unenforceable.

 

9.6.               Third Party Claims.

 

9.6.1.          Third Party Claims – Course
of Action.  If the Development,
Manufacture, use, sale or importation of a Licensed Product is alleged by a
Third Party to infringe a Third Party’s Patent Right(s) or misappropriate
a Third Party’s trade secret, the Party becoming aware of such allegation shall
promptly notify the other Party thereof, in writing, reasonably detailing the
claim.

 

9.6.2.          Additional Third Party
Licenses.  If VGX is required or
deems it is desirable to license one or more Patent Rights from one or more
Third Parties in order to make, have made, use, sell, offer for sale, import or
otherwise exploit a Licensed Product in the Licensed Field under the terms of
this Agreement, VGX, after good faith consultation with Genetronics, and at VGX’s
own expense, shall have the right, but not the obligation, to negotiate and
obtain a license under such Patent Right(s) (each such Third Party license
referred to herein as an “Additional Third Party License”).

 

9.6.3.          Third Party Suit.  If a Third Party sues a Party (the “Sued
Party”) alleging that the Sued Party’s Development, Manufacture, or
Commercialization of any Licensed Product infringes or would infringe such
Third Party’s Patent Right(s) or misappropriates such Third Party’s trade
secret(s), then upon the Sued Party’s request and in connection with the Sued
Party’s defense of any such Third Party suit, the other Party shall provide
reasonable assistance to the Sued Party for such defense and shall join such
suit if deemed a necessary party, all at the Sued Party’s expense.  The Sued Party shall keep the other Party, if
such other Party has not joined in such suit, reasonably informed prior to and
during the pendency of any such suit. 
The Sued Party shall not admit the invalidity of any patent within the VGX Patent Rights (if the Sued Party is
Genetronics), Genetronics Patent Rights (if the Sued Party is VGX) or Joint Patent Rights, nor settle any
such suit, without written consent of the other Party.

 

25

 

9.7.               Patent Marking, Certification and Term Restoration.

 

9.7.1.          Patent Marking.  To the extent it is commercially feasible to
do so, each Party agrees to mark and have its Affiliates and all Sublicensees
mark all Licensed Products (or their containers or labels) sold pursuant to
this Agreement in the country or countries of Manufacture and sale thereof
where failure to mark adversely affects the recovery of damages, and taking
into account manufacturing efficiencies in relation to non-U.S. markets.

 

9.7.2.          Patent Certifications.  Each Party shall immediately give written
notice to the other that any certification of which it becomes aware has been
filed pursuant to 21 U.S.C. § 355(b)(2)(A), or § 355(j)(2)(A)(vii) (or
any amendment or successor statute thereto) claiming that the VGX Patent Rights, Genetronics Patent Rights,
or Collaboration Patent Rights covering any Licensed Product are invalid or
that infringement would not arise from the Development, Manufacture or
Commercialization of such product by a Third Party.

 

9.7.3.          Patent Term Restoration.  The Parties shall cooperate with each other
in obtaining patent term restoration or extension anywhere in the Territory,
including under 35 U.S.C. § 156, where applicable to any Patent Right covering
the Development, Manufacture, or Commercialization of any Licensed Product.  If any election with respect to obtaining
such patent term restoration is to be made with respect to any such Patent
Right, which election in VGX’s reasonable
judgment would materially affect the Commercialization of such Licensed
Product, then VGX shall make such
election (after consultation with Genetronics).

 

10.           GOVERNMENT APPROVALS.

 

10.1.             Each Party’s Obligations.  Each of Genetronics and VGX shall use its good faith efforts to
eliminate any concern on the part of any court or government authority
regarding the legality of the proposed transaction, including, if required by
federal or state antitrust authorities, promptly taking all steps to secure
government antitrust clearance, including, without limitation, cooperating in
good faith with any government investigation including the prompt production of
documents and information demanded by a second request for documents and of
witnesses if requested.

 

10.2.             Additional Approvals.  Genetronics and VGX shall cooperate and use respectively all reasonable efforts to
make all other registrations, filings and applications, to give all notices and
to obtain as soon as practicable all governmental or other consents, transfers,
approvals, orders, qualifications authorizations, permits and waivers, if any,
and to do all other things necessary or desirable for the consummation of the
transactions as contemplated hereby. 
Neither Party shall be required, however, to divest or out-license
products or assets or materially change its business if doing so is a condition
of obtaining approval under governmental approvals of the transactions
contemplated by this Agreement.

 

11.           TERM AND TERMINATION.

 

11.1.             Term. 
The term of this Agreement (“Term”) shall commence on the
Effective Date and extend unless this Agreement is terminated earlier in accordance
with this Section 11, until the last to expire of any Royalty Period for
any Licensed Product.

 

26

 

11.2.             Termination.

 

11.2.1.        Termination For Cause.  This Agreement may be terminated effective immediately
by written notice by either Party at any time during the Term if the other
Party materially breaches any provision of this Agreement, which breach remains
uncured for sixty (60) days measured from the date written notice of such
breach is given to the breaching Party, provided, however,
that if such breach is not susceptible of cure within the stated period and the
breaching Party uses diligent good faith efforts to cure such breach, the
stated period shall be extended by an additional sixty (60) days.

 

11.2.2.        Effects of Termination.

 

(i)         Termination
for Cause by Genetronics.  In
the event Genetronics terminates this Agreement in its entirety or with respect
to any Licensed Product for cause pursuant to Section 12.2.1, (i) the
license for VGX Device Improvements
granted by VGX to Genetronics under Section 2.2.2
shall become perpetual and irrevocable, and (ii) except as otherwise
expressly provided herein, all rights and obligations of each Party hereunder
in their entirety or with respect to such Licensed Product, as applicable,
shall cease, including, all rights and licenses granted by either Party to the
other Party hereunder.

 

(ii)        Termination
for Cause by VGX  In the event of an uncured material breach by
Genetronics, VGX may elect, at its discretion,
(a) to terminate all or any portion of this Agreement for cause pursuant
to Section 12.2.1, in which case licenses to those VGX Device Improvements granted by Genetronics to VGX under Section 2.2.2 shall become fully
paid-up, perpetual, non-exclusive, irrevocable and royalty-free, except as
otherwise expressly provided herein, all other rights and obligations of each
Party so terminated shall cease; or (b) not to terminate, but to pay
royalties reduced by fifty (50) percent on those Licensed Product(s) that
are the subject of the breach for the remainder of the relevant Royalty Term.

 

(iii)       Effect of
Termination on Sublicenses. 
Upon any termination of this Agreement, all Sublicenses granted by VGX prior to such termination may, at
Genetronics’ sole discretion on a case-by-case basis, be assumed by Genetronics
in accordance with their terms, except that Genetronics shall not be required
in connection with any such assumption to take on obligations greater than
those of Genetronics under this Agreement.

 

(iv)       Effect of
Termination on Manufacturing-Related Agreements.  Unless otherwise stated therein, a
termination of this Agreement shall result in termination of any and all
provisions of any Clinical Supply Agreement or the Commercial Supply Agreement
between the parties herein and in effect at the time of termination of this
Agreement.

 

11.3.             Insolvency.

 

11.3.1.        Termination for Insolvency.  This Agreement may be terminated by written
notice by either Party at any time during the Term upon the declaration by a
court of competent jurisdiction that the other Party is bankrupt and, pursuant
to the U.S. Bankruptcy Code such other Party’s assets are to be liquidated, the
filing or institution of bankruptcy, liquidation or receivership proceedings
(other than reorganization proceedings under Chapter 11 of the U.S. Bankruptcy
Code), or upon an assignment of a substantial portion of the assets for the
benefit of creditors by the other Party, or in the event a receiver or
custodian is appointed for such Party’s 

 

27

 

business, or
if a substantial portion of such Party’s business is subject to attachment or
similar process; provided, however, that in the case of any involuntary
bankruptcy proceeding such right to terminate shall only become effective if
the proceeding is not dismissed within 60 days after the filing thereof.

 

11.3.2.        Effect on Licenses.  All rights and licenses granted under or
pursuant to this Agreement by one Party to the other Party are, for all purposes
of Section 365(n) of Title 11 of the United States Code (“Title 11”),
licenses of rights to “intellectual property” as defined in Title 11.  Each Party agrees that the other Party, as
licensee of such rights under this Agreement shall retain and may fully
exercise all of its rights and elections under Title 11.  Each Party further agrees and acknowledges
that the upfront payment and Development Payments, and all other payment by VGX to Genetronics hereunder, other than
royalty payments pursuant to Section 6.3.1 (and subject to reduction
pursuant to Section 6.3.3) do not constitute royalties within the meaning
of Section 365(n) of Title 11 or relate to licenses of intellectual
property hereunder.  Each Party agrees
during the term of this Agreement to create and maintain current copies or, if
not amenable to copying, detailed descriptions or other appropriate
embodiments, to the extent feasible, of all such intellectual property.  If a case is commenced by or against a Party
under Title 11 (the “Title 11 Party”), such Party (in any capacity,
including debtor-in-possession) and its successors and assigns (including,
without limitation, a Title 11 Trustee) shall,

 

(i)         as the other Party may
elect in a written request, immediately upon such request:

 

(a)          perform all of the obligations
provided in this Agreement to be performed by the Title 11 Party including,
where applicable and without limitation, providing to the other Party portions
of such intellectual property (including embodiments thereof) held by the Title
11 Party and such successors and assigns or otherwise available to them; or

 

(b)         provide
to the other Party all such intellectual property (including all embodiments
thereof) held by the Title 11 Party and such successors and assigns or
otherwise available to them; and

 

(ii)        not interfere with the
rights of the other Party under this Agreement, or any agreement supplemental
hereto, to such intellectual property (including such embodiments), including
any right to obtain such intellectual property (or such embodiments) from
another entity.

 

11.3.3.        Rights to Intellectual
Property.  If a Title 11 case is
commenced by or against Genetronics, and this Agreement is rejected as provided
in Title 11, and VGX elects to retain its
rights hereunder as provided in Title 11, then Genetronics (in any capacity,
including debtor-in-possession) and its successors and assigns (including,
without limitation, a Title 11 Trustee) shall grant to VGX a non-exclusive right of access to, and the right to obtain
possession of and to benefit from, each of the following, which the Parties
expressly agree constitute “embodiments” of intellectual property licensed to VGX under the Agreement for the purposes of Section 365(n) of
the Bankruptcy Code:  (i) copies of
pre-clinical and clinical research data and results regarding Licensed
Products, (ii) any tools, dyes, drawings, designs or specifications
relating to Licensed Products customized by Genetronics at VGX’s request, (iii) copies of laboratory
notes 

 

28

 

and notebooks
related to any Licensed Product, (iv) Regulatory Filings and Regulatory
Approvals related to any Licensed Product or its Manufacture, (vii) rights
of reference in respect of Regulatory Filings and Regulatory Approvals, and (viii) all
other embodiments of such intellectual property, in Genetronics’s possession or
Control.  The Parties agree that (i) Genetronics’s
obligations to Manufacture and supply any Device are supplementary rights to
the intellectual property rights licensed to VGX
under the Agreement and are entitled to the protection of Section 365(n) and
(ii) only the payments specifically characterized as royalties under the
Agreement, and no other obligations, constitute royalties within the meaning of
Section  §365(n).

 

11.3.4.        Additional Rights.  All rights, powers and remedies of a Party
provided herein are in addition to and not in substitution for any and all
other rights, powers and remedies now or hereafter existing at law or in equity
(including, without limitation, Title 11) in the event of the commencement of a
Title 11 case by or against the Title 11 Party. 
A non-Title 11 Party, in addition to the rights, power and remedies
expressly provided herein, shall be entitled to exercise all other such rights and
powers and resort to all other such remedies as may now or hereafter exist at
law or in equity (including, without limitation, Title 11) in such event.  The Parties agree that they intend the
foregoing rights to extend to the maximum extent permitted by law, including,
without limitation, for purposes of Title 11:

 

(i)         the right of access to
any intellectual property (including all embodiments thereof) of the Title 11
Party, or any Third Party with whom the Title 11 Party contracts to perform an
obligation of the Title 11 Party under this Agreement, and, in the case of the
Third Party, which is necessary for the Development, Manufacture and
Commercialization of Licensed Products; and

 

(ii)        the right to contract
directly with any Third Party described in Section 2.1.3 (Sublicensing to
Third Parties) to complete the contracted work.

 

11.4.             Change of Control.

 

11.4.1.        Change of Control Notice.  Each Party shall notify the other Party in
writing, referencing this Section of the Agreement, immediately upon any
Change of Control, and shall provide such notice where possible at least sixty
(60) days prior to the Change of Control.

 

11.4.2.        Right to Terminate if
Confirmation of Continued Priority Not Received.  Genetronics may terminate this Agreement upon
any Change of Control of VGX unless prior to sixty (60) days following such
Change of Control, Genetronics has received from the other Party, and any Third
Party who is acquiring or has acquired Control of VGX, written confirmation
reasonably satisfactory to Genetronics to the effect that (i) after such
Change of Control, the Development, Manufacture, and Commercialization of
Licensed Products as contemplated by the Agreement will have a priority for the
other Party following such Change of Control which is equal to or greater than
the priority that such Development, Manufacture, and Commercialization had for
VGX upon signing this Agreement; and (ii) that the other Party will
continue to meet all of its obligations under the Agreement following such
Change of Control.

 

29

 

11.5.             Accrued Rights.  Expiration or termination of this Agreement
for any reason shall be without prejudice to any right which shall have accrued
to the benefit of either Party prior to such termination, including, without
limitation, damages arising from any breach under this Agreement.  Expiration or termination of this Agreement
shall not relieve either party from any obligation which is expressly indicated
to survive such expiration or termination.

 

11.6.             Disposition of Inventory.  VGX
shall have the right to continue to sell Licensed Product inventory
Manufactured prior to the effective date of termination of this Agreement for a
reasonable time after the effective date of such termination (not to exceed
twelve (12) months), provided that VGX
makes any required royalty payments with respect to such sales pursuant to Section 6.

 

11.7.             Survival. 
Expiration or termination of this Agreement shall not relieve the
Parties of any obligation accruing before such expiration or termination.  The provisions of this Agreement that must,
by their nature, survive expiration or termination of this Agreement to give
effect to their intent, shall so survive, including without limitation Section 6.4
(Reports and Payments), Section 7.1 (Confidentiality); Section 12
(Indemnification and Insurance) and Section 11 (Term and
Termination).  Any expiration or early
termination of this Agreement shall be without prejudice to the rights of
either Party against the other accrued or accruing under this Agreement before
termination.  In the event that either
Party has license rights following termination that require the payment of
royalties based on Net Sales of Licensed Products, the provisions of this
Agreement regarding the calculation of Net Sales and the reporting and auditing
of amounts payable with respect to such Net Sales shall apply, with appropriate
substitution for Genetronics for VGX or
vice versa if the royalties are payable by Genetronics to VGX.

 

12.           INDEMNIFICATION AND INSURANCE.

 

12.1.             Indemnification by VGX.  VGX
shall indemnify, defend and hold harmless Genetronics, each of its Affiliates,
and each of its and its Affiliates’ employees, officers, directors and agents
(each, a “Genetronics Indemnified Party”) from and against any and all
liability, loss, damage, expense (including reasonable attorneys’ fees and
expenses) and cost (collectively, a “Liability”) that the Genetronics
Indemnified Party may be required to pay to one or more Third Parties resulting
from or arising out of:

 

(a)          any
claims of any nature arising out of the Manufacture of Genetic Constructs
pursuant to Section 5.3 by, on behalf of, or under the authority of VGX;

 

(b)         any
claims of any nature arising out of the Development or Commercialization of any
Licensed Product by, on behalf of, or under the authority of, VGX (other than claims by any Genetronics
Indemnified Party), other than claims by Third Parties relating to patent
infringement arising out of the exercise of rights under the Genetronics
Licensed Technology ; or

 

30

 

(c)          the
breach by VGX of any of its
representations, warranties or covenants set forth herein;

 

except, in each case, to the extent caused by the
negligence or willful misconduct of Genetronics or any Genetronics Indemnified
Party or is otherwise subject to indemnification by Genetronics.  Notwithstanding the foregoing, VGX shall have no obligation to defend,
indemnify or hold harmless any Genetronics Indemnified Party from and against
any Liability arising out of or resulting from the infringement of a Third
Party patent.

 

12.2.             Indemnification by Genetronics.  Genetronics shall indemnify, defend and hold
harmless VGX, each of its Affiliates,
Sublicensees, distributors and each of its and their respective employees,
officers, directors and agents (each, a “VGX
Indemnified Party”) from and against any and all Liabilities that the VGX Indemnified Party may be required to pay to
one or more Third Parties resulting from or arising out of:

 

(a)          any
claims of any nature arising out of the Manufacture of Devices pursuant to Section 5.4
by, on behalf of, or under the authority of Genetronics (except to the extent
such claims relate to specifications for the Devices provided by VGX, which claims shall fall under VGX’s obligations under Section 13.1); or

 

(b)         the
breach by Genetronics of any of its representations, warranties or covenants
set forth herein;

 

except, in each case, to the extent caused by the
negligence or willful misconduct of VGX
or any VGX Indemnified Party or is
otherwise subject to indemnification by VGX.  Notwithstanding the foregoing, Genetronics
shall have no obligation to defend, indemnify or hold harmless any VGX Indemnified Party from and against any
Liability arising out of or resulting from the infringement of a Third Party
patent.

 

12.3.             Procedure. 
Each Party shall notify the other in the event it becomes aware of a
claim for which indemnification may be sought hereunder.  In case any proceeding (including any governmental
investigation) shall be instituted involving any Party in respect of which
indemnity may be sought pursuant to this Section 12, such Party (the “Indemnified
Party”) shall promptly notify the other Party (the “Indemnifying Party”)
in writing and the Indemnifying Party and Indemnified Party shall meet to
discuss how to respond to any claims that are the subject matter of such
proceeding.  The Indemnifying Party, upon
request of the Indemnified Party, shall retain counsel reasonably satisfactory
to the Indemnified Party to represent the Indemnified Party and shall pay the
fees and expenses of such counsel related to such proceeding.  In any such proceeding, the Indemnified Party
shall have the right to retain its own counsel, but the fees and expenses of
such counsel shall be at the expense of the Indemnified Party unless (i) the
Indemnifying Party and the Indemnified Party shall have mutually agreed to the
retention of such counsel or (ii) the named parties to any such proceeding
(including any impleaded parties) include both the Indemnifying Party and the
Indemnified Party and representation of both Parties by the same counsel would
be inappropriate due to actual or potential differing interests between
them.  All such fees and expenses shall
be reimbursed as they are incurred.  The
Indemnifying Party shall not be liable for any settlement of any proceeding
effected without 

 

31

 

its written consent, but if settled with such
consent or if there be a final judgment for the plaintiff, the Indemnifying
Party agrees to indemnify the Indemnified Party from and against any loss or
liability by reason of such settlement or judgment.  The Indemnifying Party shall not, without the
written consent of the Indemnified Party, effect any settlement of any pending
or threatened proceeding in respect of which the Indemnified Party is, or
arising out of the same set of facts could have been, a party and indemnity
could have been sought hereunder by the Indemnified Party, unless such
settlement includes an unconditional release of the Indemnified Party from all
liability on claims to which the indemnity relates that are the subject matter
of such proceeding.

 

12.4.             Insurance. 
Each Party further agrees to obtain and maintain, [once the Licensed
Product enters clinical trials], Commercial General Liability Insurance in the
United States, including Products Liability coverage with carriers having A.M.
Best rating of A-VII or better to cover its indemnification obligations under
Sections 12.1 or 12.2, as applicable, with limits of not less than $1
million per occurrence and $3 million in the aggregate, or during any period in
which such Party has a market capitalization of at least $500 million, a
program of self-insurance.  In the event
that clinical trials are to be conducted outside of the United States, the
Parties shall discuss commercially reasonable and appropriate insurance
coverage, which in any case shall not be unduly burdensome to the Parties.

 

13.           MISCELLANEOUS.

 

13.1.             Assignment. 
Neither this Agreement, nor any right or obligation hereunder may be
assigned or delegated, in whole or part, by either Party without the prior
express written consent of the other (which consent shall not be unreasonably
withheld or delayed) except as expressly set forth below in this Section 13.1.  Notwithstanding the foregoing, either Party
may, without the written consent of the other Party, assign (i) any or all
of this Agreement and its rights and delegate its obligations hereunder to any
of its Affiliates or (ii) the Agreement as a whole to a Third Party in
connection with the transfer or sale of all or substantially all of its
business relating to the subject matter of this Agreement (provided that any
such assignment by VGX to a Third Party shall be deemed a Change of Control of
VGX for purposes of Section 11.4. 
Each Party shall promptly notify the other Party of any assignment or
transfer under the provisions of this Section. 
This Agreement shall be binding upon the successors and permitted
assigns of the Parties and the name of a Party appearing herein shall be deemed
to include the names of such Party’s successors and permitted assigns to the
extent necessary to carry out the intent of this Agreement.  Any assignment not in accordance with this Section 13.1
shall be void.

 

13.2.             Further Actions.  Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of the
Agreement.

 

13.3.             Force Majeure.  Nonperformance of a Party under this
Agreement (other than for the payment of money) shall be excused to the extent
that performance is rendered impossible by strike, fire, earthquake, flood,
governmental acts or orders or restrictions, failure of suppliers, or any other
reason where failure to perform, is beyond the reasonable control and not
caused by the negligence, intentional conduct or misconduct of the 

 

32

 

nonperforming Party.  The nonperforming Party shall notify the
other Party promptly should such circumstances arise, giving an indication of
the likely extent and duration thereof, and shall use all Commercially Reasonable
Efforts to resume performance of its obligations as soon as practicable,
provided, however, that neither Party shall be required to settle any labor
dispute or disturbance.

 

13.4.             Correspondence and Notices.

 

13.4.1.        Ordinary Notices.  Correspondence, reports, documentation, and
any other communication in writing between the Parties in the course of
ordinary implementation of this Agreement shall be delivered by hand, sent by
facsimile transmission (receipt verified), or by nationally recognized
overnight delivery service to the employee or representative of the other Party
who is designated by such other Party to receive such written
communication.  In the absence of a
specific designation, such notices shall be addressed as follows:

 

To Genetronics:                                                           Genetronics, Inc.

11494 Sorrento Valley Road

San Diego, California 92121

Attn: President

 

To VGX:                                                                                                  VGX Pharmaceuticals, Inc.

450 Sentry Parkway

Blue Bell, PA 19422

Attn: President

 

13.4.2.        Extraordinary Notices.  Extraordinary notices and communications
(including, without limitation, notices of termination, force majeure, material
breach, change of address) shall be in writing and delivered by hand or sent by
nationally recognized overnight delivery service, prepaid registered or
certified air mail, or by facsimile confirmed by prepaid first class,
registered or certified mail letter, and shall be deemed to have been properly
served to the addressee upon receipt of such written communication.

 

All correspondence to VGX
shall be addressed as follows:

 

VGX Pharmaceuticals, Inc.

450 Sentry Parkway

Blue Bell, PA 19422

Attn:President

Fax: 267-440-4242

 

with a copy to:

 

VGX Pharmaceuticals, Inc.

450 Sentry Parkway

Blue Bell, PA 19422

Attn: Senior Vice
President, Business Development

Fax:  267-440-4208

 

33

 

All correspondence to
Genetronics shall be addressed as follows:

 

Genetronics, Inc.

11494 Sorrento Valley Road

San Diego, California 92121

Attn: President

Fax:  858-597-0451

 

with a copy to:

 

Genetronics, Inc.

11494 Sorrento Valley Road

San Diego, California 92121

Attn: Director, Intellectual Property 

Fax:  858-597-0451

 

13.5.             Amendment. 
No amendment, modification or supplement of any provision of this
Agreement shall be valid or effective unless made in writing and signed by a
duly authorized officer of each Party.

 

13.6.             Waiver. 
No provision of the Agreement shall be waived by any act, omission or
knowledge of a Party or its agents or employees except by an instrument in
writing expressly waiving such provision and signed by a duly authorized
officer of the waiving Party.

 

13.7.             Severability.  If any clause or portion thereof in this
Agreement is for any reason held to be invalid, illegal or unenforceable, the
same shall not affect any other portion of this Agreement, as it is the intent
of the Parties that this Agreement shall be construed in such fashion as to
maintain its existence, validity and enforceability to the greatest extent
possible.  In any such event, this
Agreement shall be construed as if such clause or portion thereof had never
been contained in this Agreement, and there shall be deemed substituted
therefor such provision as shall most nearly carry out the intent of the
Parties as expressed in this Agreement to the fullest extent permitted by
applicable law.

 

13.8.             Descriptive Headings.  The descriptive headings of this Agreement
are for convenience only and shall be of no force or effect in construing or
interpreting any of the provisions of this Agreement.

 

13.9.             Governing Law; Venue.  This Agreement, and all claims arising under
or in connection therewith, shall be governed by and interpreted in accordance
with the substantive laws of the State of Delaware, without regard to conflict
of law principles thereof and without giving effect to the United Nations
Convention on Contracts for the International Sale of Goods, the 1974
Convention on the Limitation Period in the 

 

34

 

International Sale of Goods (the “1974
Convention”) and the Protocol amending the 1974 Convention, done at Vienna April 11,
1980, except for the interpretation of patent law, which shall be interpreted
in accordance with the patent laws of each country in which a patent has been
granted or patent application has been filed. 
Venue for any action brought under this Agreement shall lie exclusively
in the state courts of the State of Delaware, United States of America and both
Parties hereby consent to such venue.

 

13.10.           Entire Agreement.  This Agreement constitutes and contains the
complete, final and exclusive understanding and agreement of the Parties with
respect to the subject matter hereof and cancels and supersedes any and all
prior negotiations, correspondence, understandings and agreements, whether oral
or written, between the Parties respecting the subject matter hereof.

 

13.11.           Independent Contractors.  Both Parties are independent contractors
under this Agreement.  Nothing herein
contained shall be deemed to create an employment, agency, joint venture or
partnership relationship between the Parties hereto or any of their agents or
employees, or any other legal arrangement that would impose liability upon one
Party for the act or failure to act of the other Party.  Neither Party shall have any express or
implied power to enter into any contracts or commitments or to incur any
liabilities in the name of, or on behalf of, the other Party, or to bind the
other Party in any respect whatsoever.

 

13.12.           Counterparts.  This Agreement may be executed in any number
of counterparts, each of which need not contain the signature of more than one
Party but all such counterparts taken together shall constitute one and the
same agreement.

 

13.13.           Future Relationships.  Nothing contained in this Agreement shall be
construed, by implication or otherwise, as an obligation of any Party hereto to
enter into a further agreement regarding the subject matter of this Agreement.

 

13.14.           Interpretation.  The use of any gender herein shall be deemed
to be or include the other genders and the use of the singular herein shall be
deemed to include the plural (and vice versa), wherever appropriate. The words “include”,
“includes” and “including” shall be deemed to be followed by the phrase “without
limitation.” The word “will” shall be construed to have the same meaning and
effect as the word “shall.” Unless the context requires otherwise (a) any
definition of or reference to any agreement, instrument or other document
herein shall be construed as referring to such agreement, instrument or other
document as from time to time amended, supplemented or otherwise modified
(subject to any restrictions on such amendments, supplements or modifications
set forth herein), (b) any reference herein to any Person shall be
construed to include the Person’s successors and assigns, (c) the words “herein”,
“hereof” and “hereunder”, and words of similar import, shall be construed to
refer to this Agreement in its entirety and not to any particular provision
hereof, and (d) all references herein to Articles, Sections, or Schedules
shall be construed to refer to Articles, Sections, and Schedules of this
Agreement.

 

13.15.           No Third Party Rights or Obligations.  No provision of this Agreement shall be
deemed or construed in any way to result in the creation of any rights or
obligation in any Person not a Party to this Agreement.

 

35

 

IN WITNESS WHEREOF, duly
authorized representatives of the Parties have duly executed this Agreement to
be effective as of the Effective Date.

 

	
  VGX PHARMACEUTICALS, INC.

  	
   

  	
  GENETRONICS, INC.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By 

  	
   /s/ J. Joseph Kim

  	
   

  	
  By 

  	
   /s/ Avtar Dillon

  
	
  Name: J. Joseph Kim

  	
   

  	
  Name: Avtar Dillon

  
	
  Title: President & CEO

  	
   

  	
  Title: President & CEOExhibit 10.66

 

OMB Approval
0990-0115

 

	
   

  	
  1.               THIS CONTRACT IS A RATED ORDER

  	
  RATING

  	
  PAGE OF PAGES

  
	
  AWARD/CONTRACT

  	
  UNDER DPAS (15 CFR 350)                               

  	
  N/A

  	
  1

  	
  45

  
	
   

  	
   

  	
   

  
	
  2.               CONTRACT (Proc. Inst. Ident.) NO.

  HHSN272200800063C

  	
  3.               EFFECTIVE DATE

  September 30, 2008

  	
  4.               REQUISITION/PURCHASE REQUEST/PROJECT NO.

  750904

  
	
   

  	
   

  	
   

  
	
  5.               ISSUED BY

  	
  CODE

  	
   

  	
  6.               ADMINISTERED BY (If
  other than Item 6)

  	
  CODE

  
	
  Office of
  Acquisitions, DEA

  National Institute of Allergy and Infectious Diseases

  National Institutes of Health, DHHS

  6700-B Rockledge Dr., Room 3214, MSC 7612

  Bethesda, Maryland 20892-7612

  	
   

  AIDS RCB

  RFP NUMBER:
  NIH-NIAID-DAIDS-BAA-08-16

  NIAID Contract # N01-AI-80063

  
	
   

  	
   

  
	
  7.               NAME AND ADDRESS OF CONTRACTOR (No. street, county, state and ZIP Code)

  	
  8.               DELIVERY

  
	
   

  	
  o 
  FOB ORIGIN

  	
  x  OTHER (See below)

  FOB Destination

  
	
   

  	
   

  	
   

  
	
  VGX
  Pharmaceuticals, Inc.

  	
  VIN#1150944

  	
  9.               DISCOUNT FOR PROMPT PAYMENT

  
	
  450 Sentry
  Parkway East

  	
  N/A

  
	
  Blue Bell,
  Pennsylvania 19422

  	
   

  
	
   

  	
  10.          SUBMIT INVOICES

  	
  ITEM

  
	
   

  	
   

  	
   

  
	
  CODE

  	
  FACILITY CODE

  	
  ADDRESS SHOWN IN:

  	
  Art. G.3.

  
	
   

  	
   

  	
   

  	
   

  
	
  11.  SHIP
  TO/MARK FOR

  	
  CODE

  	
  N/A

  	
  12.   PAYMENT
  WILL BE MADE BY

  	
  CODE

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
    Article
  F.1.

  	
   

  	
   

  	
    See
  Article G.3.

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  13.         AUTHORITY FOR USING OTHER FULL AND OPEN
  COMPETITION:

  	
  14.         ACCOUNTING AND APPROPRIATION DATA

  
	
   

  	
   

  	
  TIN# 51-0404886

  	
  SOC 25.55

  	
  DUNS 063784784

  
	
  o 
  10 U.S.C. 2304(c)(     )

  	
  o 
  41 U.S.C. 253(c)(     )

  	
  CAN 8-8470035

  	
  $4,663,588

  	
   

  
															

 

	
  15A.          ITEM NO.

  	
  15B.           SUPPLIES/SERVICES

  	
  15C.  QUANTITY

  	
  15D.  UNIT

  	
  15E.  UNIT PRICE

  	
  15F.  AMOUNT

  
	
  Title: HIV Vaccine
  Design and Development Teams project Entitled “Development of Improved DNA
  Vaccines and Electroporation Delivery Devices for HIV Prophylactic HIV
  Vaccines”

   

   

  Period:  September 30, 2008 through September 29,
  2015

  Contract Type: Cost
  Reimbursement with Options (Completion)

  	
   

  	
   

  	
  FY 08 Base

  FY 09 Option

  FY 10 Option

  FY 11 Option

  FY 12 Option

  FY 14 Option

  FY 15 Option

  	
  $4,663,588

  $6,573,776

  $5,258,144

  $2,717,534

  $2,056,112

  $1,193,230

  $1,132,465

  
	
   

  	
  15G.    
  TOTAL AMOUNT OF CONTRACT        

  	
  $23,594,849

  
	
   

  	
   

  	
   

  
	
  16.  TABLE OF CONTENTS

  

 

	
  x

  	
  SEC.

  	
  DESCRIPTION

  	
  PAGE(S)

  	
  x

  	
  SEC.

  	
  DESCRIPTION

  	
  PAGE(S)

  
	
  PART I - THE SCHEDULE

  	
  PART II - CONTRACT
  CLAUSES

  
	
  x

  	
  A

  	
  SOLICITATION/CONTRACT FORM

  	
  1

  	
  x

  	
  I

  	
  CONTRACT CLAUSES

  	
  35

  
	
  x

  	
  B

  	
  SUPPLIES OR SERVICES AND PRICE/COST

  	
  4

  	
  PART III - LIST OF
  DOCUMENTS, EXHIBITS AND OTHER ATTACH.

  
	
  x

  	
  C

  	
  DESCRIPTION/SPECS./WORK STATEMENT

  	
  12

  	
  x

  	
  J

  	
  LIST OF ATTACHMENTS

  	
  44

  
	
  x

  	
  D

  	
  PACKAGING AND MARKING

  	
  17

  	
  PART IV -
  REPRESENTATIONS AND INSTRUCTIONS

  
	
  x

  	
  E

  	
  INSPECTION AND ACCEPTANCE

  	
  18

  	
  x

  	
  K

  	
  REPRESENTATIONS, CERTIFICATIONS AND

  	
  45

  
	
  x

  	
  F

  	
  DELIVERIES OR PERFORMANCE

  	
  19

  	
   

  	
   

  	
  OTHER STATEMENTS OF OFFERORS

  	
   

  
	
  x

  	
  G

  	
  CONTRACT ADMINISTRATION DATA

  	
  22

  	
  o

  	
  L

  	
  INSTRS., CONDS., AND NOTICES TO OFFERORS

  	
   

  
	
  x

  	
  H

  	
  SPECIAL CONTRACT REQUIREMENTS

  	
  26

  	
  o

  	
  M

  	
  EVALUATION FACTORS FOR AWARD

  	
   

  

 

	
  CONTRACTING
  OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE

  
	
   

  
	
  17.  x CONTRACTOR’S NEGOTIATED AGREEMENT (Contractor is required to sign this document and
  return            copies to
  issuing office.)  Contractor
  agrees to furnish and deliver all items or perform all the services set forth
  or otherwise identified above and on any continuation sheets for the
  consideration stated herein.  The
  rights and obligations of the parties to this contract shall be subject to
  and governed by the following documents: 
  (a) this award/contract, (b) the solicitation, if any, and (c) such
  provisions, representations, certifications, and specifications, as are
  attached or incorporated by reference herein. 
  (Attachments are listed herein.)

  	
   

  	
  18.  o  AWARD  (Contractor is not required to sign this document.)  Your offer on Solicitation Number                                            ,
  including the additions or changes made by you which additions or changes are
  set forth in full above, is hereby accepted as to the items listed above and
  on any continuation sheets.  This award
  consummates the contract which consists of the following documents:  (a) the Government’s solicitation and your
  offer, and (b) this award/contract.  No
  further contractual document is necessary.

  
	
   

  	
   

  
	
  19A.          NAME AND TITLE OF SIGNER   (Type or print)

  	
  20A.          NAME OF CONTRACTING OFFICER

  
	
  NIRANJAN Y. SARDESAI, SR.
  VP, R&D

  	
  Eileen D. Webster-Cissel

  Contracting Officer, Office of Acquisitions, DEA, NIAID, NIH, DHHS 

  
	
   

  	
   

  
	
  19B.           NAME OF CONTRACTOR

  	
  19C.           DATE SIGNED

  	
  20B.           UNITED STATES OF AMERICA

  	
  20C.           DATE SIGNED

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  9/25/08

  	
   

  	
  9/26/08

  
	
  VGX Pharmaceuticals,
  Inc.   /S/Niranjan Y. Sardesai

  	
   

  	
  BY

  	
  /s/ Eileen D. Webster-Cissel

  	
   

  
	
  (Signature
  of person authorized to sign)

  	
   

  	
  (Signature of Contracting
  Officer)

  	
   

  
							

 

	
  NSN
  7540-01-152-8069

  	
  26-107

  	
  STANDARD
  FORM 26 (REV. 4-85)

  
	
  PREVIOUS EDITION
  UNUSABLE

  	
  Computer Generated

  	
  Prescribed by GSA

  
	
   

  	
   

  	
  FAR (48 CFR)
  53.214(a)

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