EXHIBIT 10.1

Portions Subject to Confidential Treatment Request Under Rule 24b-2

Collaboration, Option and

License Agreement

This Agreement is entered into with effect as of the Effective Date (as defined
below)

by and between

F. Hoffmann-La Roche Ltd

with an office and place of business at Grenzacherstrasse 124, 4070 Basel,
Switzerland (“Roche Basel”)

and

Hoffmann-La Roche Inc.

with an office and place of business at 340 Kingsland Street, Nutley, New Jersey
07110, U.S.A. (“Roche Nutley”; Roche Basel and Roche Nutley together referred to
as “Roche”)

on the one hand

and

Inovio Pharmaceuticals, Inc.

with an office and place of business at 1787 Sentry Parkway West, Building 18,
Suite 400, Blue Bell, Pennsylvania 19422 U.S.A. (“Inovio”),

on the other hand.

--------------------------------------------------------------------------------

Table of Contents

 

1.   Definitions      6      1.1  

5150 Product

     6      1.2  

Adjuvant

     6      1.3  

Affiliate

     7      1.4  

Agreement

     7      1.5  

Agreement Term

     7      1.6  

Antigen

     7      1.7  

Bioequivalent Product

     7      1.8  

BLA

     7      1.9  

Calendar Quarter

     7      1.10  

Calendar Year

     7      1.11  

Change of Control

     7      1.12  

Change of Control Group

     8      1.13  

Clinical Study

     8      1.14  

Collaboration IP

     8      1.15  

Combination Product

     8      1.16  

Commercially Reasonable Efforts

     8      1.17  

Companion Diagnostic

     9      1.18  

Compulsory Sublicense

     9      1.19  

Compulsory Sublicensee

     9      1.20  

Confidential Information

     9      1.21  

Continuation Election Notice

     9      1.22  

Control

     10      1.23  

Cover

     10      1.24  

Data Package

     10      1.25  

Delivery Device

     10      1.26  

Delivery Device Patents

     10      1.27  

Development Plan

     10      1.28  

DNA Plasmid

     10      1.29  

Effective Date

     10      1.30  

EMA

     11      1.31  

Enabling Technologies

     11      1.32  

Enabling Technology Patents

     11      1.33  

EU

     11      1.34  

Existing Agreements

     11      1.35  

Expert

     11      1.36  

FBMC

     11      1.37  

FDA

     11      1.38  

FDCA

     11      1.39  

Field

     11      1.40  

First Commercial Sale

     11      1.41  

FTE

     11      1.42  

FTE Rate

     12      1.43  

GLP Tox

     12      1.44  

GMP

     12      1.45  

Group Sublicensee

     12      1.46  

Handle

     12      1.47  

HBV

     12      1.48  

HBV Product

     12      1.49  

IFRS

     12      1.50  

IND

     12   

 

- 2 -

--------------------------------------------------------------------------------

  1.51  

Initiation

     13      1.52  

Inovio 5150 Trial

     13      1.53  

Inovio 5150 Trial Plan

     13      1.54  

Inovio Background Patent Rights

     13      1.55  

Inovio IP Rights

     13      1.56  

Inovio Know-How

     13      1.57  

Inovio Patent Rights

     13      1.58  

Insolvency Event

     13      1.59  

Invention

     13      1.60  

Joint IP

     13      1.61  

Joint Know-How

     14      1.62  

Joint Patent Rights

     14      1.63  

JSC

     14      1.64  

Know-How

     14      1.65  

Net Sales

     14      1.66  

Oncology Product

     14      1.67  

Option Period

     14      1.68  

Option Right

     14      1.69  

Orphan Drug Product

     15      1.70  

Party

     15      1.71  

Patent Rights

     15      1.72  

Phase I Study

     15      1.73  

Phase II Study

     15      1.74  

Phase III Study

     15      1.75  

Product

     15      1.76  

RC Product

     15      1.77  

Regulatory Approval

     15      1.78  

Regulatory Authority

     16      1.79  

Research Plan

     16      1.80  

Research Program

     16      1.81  

Roche Group

     16      1.82  

Roche IP Rights

     16      1.83  

Roche Know-How

     16      1.84  

Roche Patent Rights

     16      1.85  

Royalty Term

     16      1.86  

Sales

     17      1.87  

Sphergen Cross-License

     17      1.88  

Sublicensee

     17      1.89  

Territory

     17      1.90  

Third Party

     18      1.91  

Third Party Product

     18      1.92  

UPenn Agreement

     18      1.93  

UPenn Patent Rights

     18      1.94  

US

     18      1.95  

US$

     18      1.96  

Valid Claim

     18      1.97  

VGXI Supply Agreement

     18      1.98  

Additional Definitions

     18    2.   Research Collaboration      19      2.1  

Conduct of the Research Programs

     19      2.2  

Records; Reports

     21   

 

- 3 -

--------------------------------------------------------------------------------

3.   Licenses and Exclusive Option Right      22      3.1  

Research Cross License

     22      3.2  

5150 Product Development and Commercialization License

     22      3.3  

License to Inovio for Improvements to Inovio Background Technology

     22      3.4  

Option Right

     23      3.5  

Retained Rights

     24    4.   Governance      24      4.1  

Joint Steering Committee

     24      4.2  

Members

     25      4.3  

Responsibilities of the JSC

     25      4.4  

Meetings

     25      4.5  

Minutes

     26      4.6  

Decisions

     26      4.7  

Alliance Director

     26      4.8  

Limitations of Authority

     26      4.9  

Expenses

     27      4.10  

Lifetime

     27    5.   Clinical Development and Commercialization      27      5.1  

Development

     27      5.2  

Regulatory Responsibility

     28      5.3  

Supply in General

     28      5.4  

Development and Supply of Delivery Devices

     30      5.5  

GMP

     32      5.6  

Commercialization

     32      5.7  

Diligence

     32      5.8  

Updates to Inovio

     32    6.   Payment      32      6.1  

Option Signing and Exclusivity Fee

     32      6.2  

Research and Development Support Payments

     33      6.3  

Development Event Payments

     33      6.4  

First Commercial Sale Event Payments

     35      6.5  

Sales Based Payments

     35      6.6  

Roche Royalty Payments

     36      6.7  

Disclosure of Payments

     39    7.   Accounting and reporting      39      7.1  

Invoices

     39      7.2  

DSRP Reports for Development Support Payments

     39      7.3  

Timing of Payments

     39      7.4  

Late Payment

     39      7.5  

Method of Payment

     40      7.6  

Currency Conversion

     40      7.7  

Royalty Reports

     40    8.   Taxes      40    9.   Auditing      40      9.1  

Right to Audit

     40      9.2  

Audit reports

     41      9.3  

Over-or Underpayment

     41      9.4  

Duration of Audit Rights

     41    10.   Intellectual Property      42      10.1  

Disclosure of Inventions

     42      10.2  

Ownership of Inventions

     42      10.3  

German Statute on Employee’s Inventions

     42      10.4  

Prosecution of Patent Rights Covering Inventions

     42   

 

- 4 -

--------------------------------------------------------------------------------

  10.5  

CREATE Act

     43      10.6  

Infringement

     43      10.7  

Defense

     44      10.8  

Common Interest Disclosures

     44      10.9  

Hatch-Waxman

     45      10.10  

Biosimilar or interchangeable biological products

     45      10.11  

Patent Term Extensions

     45    11.   Representations, Warranties and Covenants      46      11.1  

Inovio Representations, Warranties and Covenants

     46      11.2  

Roche Representations, Warranties and Covenants

     47    12.   Indemnification      48    13.   Liability      49    14.  
Obligation Not to Disclose Confidential Information      49      14.1  

Non-Use and Non-Disclosure

     49      14.2  

Permitted Disclosure

     49      14.3  

Press Releases

     49      14.4  

Publications

     50      14.5  

Commercial Considerations

     50    15.   Term and Termination      51      15.1  

Commencement and Term

     51      15.2  

Termination

     51      15.3  

Consequences of Termination

     52      15.4  

Survival

     56    16.   Miscellaneous      56      16.1  

Bankruptcy

     56      16.2  

Change of Control

     56      16.3  

Governing Law

     57      16.4  

Disputes

     57      16.5  

Arbitration

     57      16.6  

Assignment

     57      16.7  

Debarment

     57      16.8  

Independent Contractor

     57      16.9  

Unenforceable Provisions and Severability

     58      16.10  

Waiver

     58      16.11  

Appendices

     58      16.12  

Entire Understanding

     58      16.13  

Amendments

     58      16.14  

Invoices

     58      16.15  

Notice

     59   

 

- 5 -

--------------------------------------------------------------------------------

Collaboration, Option and License Agreement

WHEREAS, Inovio has developed novel SynCon® DNA vaccine construct technology
that may enable development of synthetic DNA vaccines targeted against, among
other things, cancers (including the DNA vaccine known as INO-5150) and
hepatitis B virus (including the DNA vaccine known as INO-1800); and

WHEREAS, Inovio has expertise in the research, development, and manufacture of
electroporation-based DNA delivery technology; and

WHEREAS, Roche has expertise in the research, development, manufacture and
commercialization of pharmaceutical and diagnostic products; and

WHEREAS, Roche and Inovio are willing to conduct a research program in the field
of oncology, with a focus on prostate cancer, for the development of a DNA
vaccine for potential development and commercialization by Roche; and

WHEREAS, Inovio is willing to grant to Roche an exclusive option for an
exclusive license for Roche to make, use, offer for sale, sell and import and
export certain DNA vaccines, including the use of Inovio’s electroporation-based
DNA delivery technology; and

WHEREAS, Inovio is willing to grant to Roche an exclusive license for Roche to
make, use, offer for sale, sell and import and export DNA vaccines based on
INO-1800 that are directed to hepatitis B viral infections and INO-5150 that are
directed to prostate cancer, including the use of Inovio’s electroporation-based
DNA delivery technology, as contemplated herein.

NOW, THEREFORE, in consideration of the mutual covenants and promises contained
in this Agreement and other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Parties hereto, intending to
be legally bound, do hereby agree as follows:

 

1. Definitions

As used in this Agreement, the following terms, whether used in the singular or
plural, shall have the following meanings:

 

1.1 5150 Product

The term “5150 Product” shall mean a product that contains as an active
ingredient at least one (1) DNA Plasmid that encodes for an engineered PSA
and/or PSMA found in the Inovio DNA vaccine known as INO-5150.

 

1.2 Adjuvant

The term “Adjuvant” shall mean a substance contained in a vaccine or delivered
separately to increase a patient’s immune response to the antigen(s) found in or
encoded by such vaccine. Adjuvants include, but are not limited to, DNA plasmids
encoding an immunomodulatory molecule, such as IL-12.

 

- 6 -

--------------------------------------------------------------------------------

1.3 Affiliate

The term “Affiliate” shall mean any individual, corporation, association or
other business entity that directly or indirectly controls, is controlled by, or
is under common control with the Party in question. As used in this definition
of Affiliate, the term “control” shall mean the direct or indirect ownership of
more than fifty percent (>50%) of the stock having the right to vote for
directors thereof or the ability to otherwise control the management of the
corporation or other business entity whether through the ownership of voting
securities, by contract, resolution, regulation or otherwise. Anything to the
contrary in this paragraph notwithstanding, Chugai Pharmaceutical Co., Ltd, a
Japanese corporation (“Chugai”), shall not be deemed an Affiliate of Roche
unless Roche provides written notice to Inovio of its desire to include Chugai
as an Affiliate of Roche.

 

1.4 Agreement

The term “Agreement” shall mean this document including any and all appendices
and amendments to it as may be added and/or amended from time to time in
accordance with the provisions of this Agreement.

 

1.5 Agreement Term

The term “Agreement Term” shall mean the period of time commencing on the
Effective Date and, unless this Agreement is terminated sooner as provided in
Article 15, expiring on the date when no royalty or other payment obligations to
Inovio under this Agreement are or will become due.

 

1.6 Antigen

The term “Antigen” shall mean a distinct and uniquely identifiable macromolecule
that is capable, under appropriate conditions, of inducing a specific immune
response, and shall include peptides, proteins, protein-constructs, and
post-translational modifications or variants of such macromolecules, as well as
other immunogens derived therefrom.

 

1.7 Bioequivalent Product

The term “Bioequivalent Product” shall mean, with respect to a given Product
sold in a given country of the Territory by Roche, its Affiliate or Sublicensee,
a product sold by a Third Party in such country that is approved as a biosimilar
or interchangeable biological product under 42 U.S.C. 262(k) or equivalent
Regulatory Approval outside the US.

 

1.8 BLA

The term “BLA” shall mean a Biologics License Application, or similar
application for marketing approval of the Products for use in the Field
submitted to the FDA, or a foreign equivalent of the FDA.

 

1.9 Calendar Quarter

The term “Calendar Quarter” shall mean each period of three (3) consecutive
calendar months, ending March 31, June 30, September 30, and December 31.

 

1.10 Calendar Year

The term “Calendar Year” shall mean the period of time beginning on January 1
and ending December 31, except for the first year which shall begin on the
Effective Date and end on December 31.

 

1.11 Change of Control

The term “Change of Control” shall mean, with respect to a Party: (a) the
acquisition by any Third Party of beneficial ownership of fifty percent (50%) or
more of the then outstanding common shares or voting power of such Party, other
than acquisitions by employee benefit

 

- 7 -

--------------------------------------------------------------------------------

plans sponsored or maintained by such Party; (b) the consummation of a business
combination involving such Party, unless, following such business combination,
the stockholders of such Party immediately prior to such business combination
beneficially own directly or indirectly more than fifty percent (50%) of the
then outstanding common shares or voting power of the entity resulting from such
business combination; or (c) the sale of all or substantially all of such
Party’s assets or business relating to the subject matter of the Agreement.

 

1.12 Change of Control Group

The term “Change of Control Group” shall mean with respect to a Party, the
person or entity, or group of persons or entities, that is the acquirer of, or a
successor to, a Party in connection with a Change of Control, together with
affiliates of such persons or entities that are not Affiliates of such Party
immediately prior to the completion of such Change of Control of such Party.

 

1.13 Clinical Study

The term “Clinical Study” shall mean a Phase I Study, a Phase II Study or a
Phase III Study, as applicable.

 

1.14 Collaboration IP

The term “Collaboration IP” shall mean all information, Inventions, Know-How
(whether or not patentable), including but not limited to, data and results and
deliverables, which are first conceived, reduced to practice, or otherwise first
made, discovered, or created pursuant to the activities conducted under a
Research Program or pursuant to a Development Plan either by (i) Inovio or its
Affiliates, and/or their employees, contractors or agents (including Inovio
Inventions), or (ii) jointly by the Parties, and/or their Affiliates, and/or
their employees, contractors or agents (including Joint Inventions).

 

1.15 Combination Product

The term “Combination Product” shall mean

 

a) a single pharmaceutical formulation containing as its active ingredients both
(i) the DNA Plasmid(s) found in a Product and (ii) one or more other
therapeutically or prophylactically active ingredients,

 

b) a combination therapy comprised of (i) the DNA Plasmid(s) found in a Product
and (ii) one or more other therapeutically or prophylactically active products,
priced and sold in a single package containing such multiple products, or

 

c) a combination therapy comprised of (i) the DNA Plasmid(s) found in a Product
and (ii) one or more other therapeutically or prophylactically active products,
packaged separately but sold together for a single price,

in each case, including all dosage forms, formulations, presentations, line
extensions, and package configurations. All references to Product in this
Agreement shall be deemed to include Combination Product.

 

1.16 Commercially Reasonable Efforts

The term “Commercially Reasonable Efforts” shall mean such level of efforts
required to carry out such obligation in sustained manner consistent with the
efforts Roche or Inovio, as applicable, devotes at the same stage of research,
development or commercialization, as applicable, for its own internally
developed pharmaceutical products in a similar area with similar market
potential, at a similar stage of their product life taking into account the
existence of other competitive products in the market place or under
development, the proprietary position of the product, the regulatory structure
involved, the anticipated profitability of the product and other relevant
factors. It is understood that such product potentially may change from time to
time based upon changing scientific, business and marketing and return on
investment considerations, and that Roche and its Affiliates do not always seek
to market its own products

 

- 8 -

--------------------------------------------------------------------------------

in every country or seek to obtain regulatory approval in every country or for
every potential indication. As a result, the exercise of diligence by Roche is
to be determined by judging Roche’s commercially reasonable efforts, taken as a
whole.

 

1.17 Companion Diagnostic

The term “Companion Diagnostic” shall mean any product that is used for
predicting and/or monitoring the response of a human being to treatment with a
Product (e.g. device, compound, kit, biomarker or service that contains a
component that is used to detect or quantify the presence or amount of an
analyte in body or tissue that affects the pathogens of the disease, etc.).

 

1.18 Compulsory Sublicense

The term “Compulsory Sublicense” shall mean a sublicense granted to a Third
Party, through an order, decree or grant of a governmental authority having
competent jurisdiction, authorizing such Third Party to manufacture, use, sell,
offer for sale, import or export a Product in a country or countries in the
Territory.

 

1.19 Compulsory Sublicensee

The term “Compulsory Sublicensee” shall mean the sublicensee of a Compulsory
Sublicense.

 

1.20 Confidential Information

The term “Confidential Information” shall mean any and all information, data or
know-how (including Know-How), whether technical or non-technical, oral or
written, that is disclosed by one Party or its Affiliates (“Disclosing Party”)
to the other Party or its Affiliates (“Receiving Party”). Confidential
Information shall not include any information, data or know-how that:

 

  (i) was generally available to the public at the time of disclosure, or
information that becomes available to the public after disclosure by the
Disclosing Party other than through fault (whether by action or inaction) of the
Receiving Party or its Affiliates,

 

  (ii) can be evidenced by written records to have been already known to the
Receiving Party or its Affiliates prior to its receipt from the Disclosing
Party,

 

  (iii) is obtained at any time lawfully from a Third Party under circumstances
permitting its use or disclosure,

 

  (iv) is developed independently by the Receiving Party or its Affiliates as
evidenced by written records other than through knowledge of Confidential
Information,

 

  (v) is required to be disclosed by the Receiving Party of its Affiliates to
comply with a court or administrative order providing the Receiving Party or its
Affiliates furnishes prompt notice (in no event less than three (3) days) to the
Disclosing Party to enable it to resist such disclosure, or

 

  (vi) is approved in writing by the Disclosing Party for release by the
Receiving Party.

Subject to (i)-(vi) above, the terms of this Agreement and Collaboration IP
shall be considered Confidential Information of all Parties.

 

1.21 Continuation Election Notice

The term “Continuation Election Notice” shall mean the notice Inovio provides to
Roche under to Section 15.3.1 or 15.3.3 describing (i) Inovio’s bona fide
intention to continue ongoing development and commercialization of Termination
Product(s) and (ii) Inovio’s request for Roche’s continuation of activities
during the termination period and/or transfer of the data, material and
information relating to the Termination Product(s) in accordance with
Section 15.3.1 or 15.3.3.

 

- 9 -

--------------------------------------------------------------------------------

1.22 Control

The term “Control” shall mean (as an adjective or as a verb including
conjugations and variations such as “Controls” “Controlled” or “Controlling”)
(a) with respect to Patent Rights and/or Know-How, the possession by a Party of
the ability to grant a license or sublicense of such Patent Rights and/or
Know-How without violating the terms of any agreement or arrangement between
such Party and any other party and (b) with respect to proprietary materials,
the possession by a Party of the ability to supply such proprietary materials to
the other Party as provided herein without violating the terms of any agreement
or arrangement between such Party and any other party.

 

1.23 Cover

The term “Cover” shall mean (as an adjective or as a verb including conjugations
and variations such as “Covered,” “Coverage” or “Covering”) that the developing,
making, using, offering for sale, promoting, selling, exporting or importing of
a given compound, formulation or product would infringe a Valid Claim in the
absence of a license under the Patent Rights to which such Valid Claim pertains.
The determination of whether a compound, formulation, process or product is
Covered by a particular Valid Claim shall be made on a country-by-country basis.

 

1.24 Data Package

The term “Data Package” shall mean, with respect to a Termination Product, all
material information in Roche’s Control that relates to the safety, efficacy,
toxicity and potential adverse effects related to the Termination Product, and
all Regulatory Approvals and filings therefor for the Termination Product.

 

1.25 Delivery Device

The term “Delivery Device” shall mean an electroporation-based DNA delivery
device developed using Inovio’s proprietary DNA delivery technology necessary or
useful for the delivery of a Product. Delivery Device shall include all future
versions and delivery devices developed by Inovio, jointly by the Parties, or by
Roche in connection with the exercise of Roche’s option to optimize the Delivery
Device in accordance with Section 5.4.3.

 

1.26 Delivery Device Patents

The term “Delivery Device Patents” shall mean all patent rights owned or
Controlled by Inovio which Cover the Delivery Device.

 

1.27 Development Plan

The term “Development Plan” shall mean any plan for collaborative clinical
development of a Product outlining the work expected to be performed by Inovio
and Roche, as such plan may be updated from time to time as provided in this
Agreement. There may be more than one (1) Development Plan, including, for
example: (i) a 5150 Product Development Plan, (ii) RC Product Development
Plan(s), and (iii) an HBV Product Development Plan.

 

1.28 DNA Plasmid

The term “DNA Plasmid” shall mean a plasmid that encodes for at least one
(1) Antigen and was either (i) selected by Inovio and provided to Roche under
this Agreement, or (ii) was synthesized by or on behalf of a Party in the course
of a Research Program hereunder. For example, the DNA Plasmids in the 5150
Product encode engineered PSA and PSMA, and the DNA Plasmids in the HBV Product
encode HBV consensus core protein, HBV clade A consensus large surface antigen,
and HBV clade C surface consensus large surface antigen.

 

1.29 Effective Date

The term “Effective Date” shall mean September 9, 2013.

 

- 10 -

--------------------------------------------------------------------------------

1.30 EMA

The term “EMA” shall mean the European Medicines Agency or any successor agency
with responsibilities comparable to those of the European Medicines Agency.

 

1.31 Enabling Technologies

The term “Enabling Technologies” shall mean (a) DNA leader sequences, (b) DNA
Adjuvants, and/or (c) DNA vectors.

 

1.32 Enabling Technology Patents

The term “Enabling Technology Patents” shall mean all Patent Rights owned or
Controlled by Inovio which Cover the Enabling Technologies, a complete list of
Enabling Technology Patents as of the Effective Date is set forth in Appendix
1.54.

 

1.33 EU

The term “EU” shall mean the European Community and all its then current member
countries.

 

1.34 Existing Agreements

The term “Existing Agreements” shall mean the UPenn Agreement, Sphergen
Cross-License, and VGXI Supply Agreement.

 

1.35 Expert

The term “Expert” shall mean a person with no less than ten (10) years of
pharmaceutical industry experience and expertise having occupied at least one
senior position within a large pharmaceutical company relating to product
development and/or licensing but excluding any current or former employee or
consultant of either Party. Such person shall be fluent in the English language.

 

1.36 FBMC

The term “FBMC” shall mean Inovio’s fully burdened manufacturing cost as such
calculated on a consistent basis by Inovio in accordance with generally accepted
accounting practices.

 

1.37 FDA

The term “FDA” shall mean the US Food and Drug Administration.

 

1.38 FDCA

The term “FDCA” shall mean the US Food, Drug and Cosmetics Act.

 

1.39 Field

The term “Field” shall mean all uses.

 

1.40 First Commercial Sale

The term “First Commercial Sale” shall mean, on a country-by-country basis, the
first invoiced sale of a Product to a Third Party by the Roche Group following
the receipt of any Regulatory Approval required for the sale of such Product, or
if no such Regulatory Approval is required, the date of the first invoiced sale
of a Product to a Third Party by the Roche Group in such country.

 

1.41 FTE

The term “FTE” shall mean a full-time equivalent person-year, based upon a total
of no less than one thousand eight hundred (1,800) working hours per year,
undertaken in connection with the conduct of research in the Research Program.
In no circumstance can the work of any given person exceed one (1) FTE.

 

- 11 -

--------------------------------------------------------------------------------

1.42 FTE Rate

The term “FTE Rate” shall mean a fully burdened rate ‘’’’ ‘’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’ ‘’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’ ‘’’’’’’’’’’ ‘’’’’’’’’ ‘’’’’’’’’’’’, and
incorporates all of Inovio’s internal costs for performing its obligations under
the Research Plan. The FTE Rate includes the costs of infrastructure and
supplies used in the ordinary course of providing such services (including
consumables).

 

1.43 GLP Tox

The term “GLP Tox” shall mean a toxicology study that is conducted in compliance
with Good Laboratory Practice and is intended to be used or is actually used to
meet the requirements for filing an IND.

 

1.44 GMP

The term “GMP” shall mean Good Manufacturing Practice according to the then
current guidelines of the ICH (International Conference on Harmonization of
Technical Requirement for Registration of Pharmaceuticals for Human Use).

 

1.45 Group Sublicensee

The term “ Group Sublicensee” shall mean any Sublicensee that is (i) not an
Affiliate of Roche; (ii) directly or indirectly controlled by Roche; and
(iii) consolidated within Roche’s externally published audited financial
statements. The term “control” in the previous sentence means the direct or
indirect ownership of more than fifty percent (>50%) of the stock having the
right to vote for directors thereof or the ability to otherwise control the
management of the corporation or other business entity whether through the
ownership of voting securities, by contract, resolution, regulation or
otherwise.

 

1.46 Handle

The term “Handle” shall mean preparing, filing, prosecuting (including
interference and opposition proceedings) and maintaining (including
interferences, reissue, re-examination, post grant reviews, inter partes
reviews, and opposition proceedings), whether in-house or through an external
law firm.

 

1.47 HBV

The term “HBV” shall mean hepatitis B virus.

 

1.48 HBV Product

The term “HBV Product” shall mean a product that contains as an active
ingredient at least one (1) DNA Plasmid that encodes for HBV consensus core
protein and/or HBV clade A consensus large surface antigen and/or HBV clade C
consensus large surface antigen found in the Inovio DNA vaccine known as
INO-1800.

 

1.49 IFRS

The term “IFRS” shall mean International Financial Reporting Standards.

 

1.50 IND

The term “IND” shall mean an application as defined in the FDCA and applicable
regulations promulgated by the FDA, or the equivalent application to the
equivalent agency in any other country or group of countries, the filing of
which is necessary to commence clinical testing of the Products in humans.

 

- 12 -

--------------------------------------------------------------------------------

1.51 Initiation

The term “Initiation” shall mean with respect to a Clinical Study, the date that
a human is first dosed with the Product in a Clinical Study approved by the
respective Regulatory Authority.

 

1.52 Inovio 5150 Trial

The term “Inovio 5150 Trial” shall mean that Phase I Study conducted in
accordance with the Inovio 5150 Trial Plan and consistent with Section 5.1.1.

 

1.53 Inovio 5150 Trial Plan

The term “Inovio 5150 Trial Plan” shall mean the plan for the conduct of the
Inovio 5150 Trial, including the budget, which is current and agreed as of the
Effective Date .

 

1.54 Inovio Background Patent Rights

The term “Inovio Background Patent Rights” shall mean all Patent Rights owned or
Controlled by Inovio as of the Effective Date and during the Agreement Term
which are useful or necessary to research, develop, manufacture or commercialize
Products and Delivery Devices, including the Delivery Device Patents and
Enabling Technology Patents, associated therewith, a complete listing of these
patent rights as of the Effective Date are set forth in Appendix 1.54 in which
such Patent Rights are categorized as Product Patents, Device Patents, and
Enabling Technology Patents.

 

1.55 Inovio IP Rights

The term “Inovio IP Rights” shall mean the Inovio Patent Rights and Inovio
Know-How.

 

1.56 Inovio Know-How

The term “Inovio Know-How” shall mean the Know-How that Inovio Controls at the
Effective Date and during the Agreement Term.

 

1.57 Inovio Patent Rights

The term “Inovio Patent Rights” shall mean the Inovio Background Patent Rights
and any Patent Rights claiming an Inovio Invention.

 

1.58 Insolvency Event

The term “Insolvency Event” shall mean circumstances under which a Party (i) has
a receiver or similar officer appointed over all or a material part of its
assets or undertaking; (ii) passes a resolution for winding-up (other than a
winding-up for the purpose of, or in connection with, any solvent amalgamation
or reconstruction) or a court makes an order to that effect or a court makes an
order for administration (or any equivalent order in any jurisdiction);
(iii) enters into any composition or arrangement with its creditors (other than
relating to a solvent restructuring); (iv) ceases to carry on business; (v) is
unable to pay its debts as they become due in the ordinary course of business.

 

1.59 Invention

The term “Invention” shall mean an invention that is conceived or reduced to
practice in connection with any activity carried out pursuant to this Agreement.
Under this definition, an Invention may be made by employees or consultants of
Inovio solely or jointly with a Third Party (an “Inovio Invention”), by
employees or consultants of the Roche Group solely or jointly with a Third Party
(a “Roche Invention”), or jointly by employees or consultants of Inovio and a
member of the Roche Group with or without a Third Party (a “Joint Invention”).

 

1.60 Joint IP

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

 

- 13 -

--------------------------------------------------------------------------------

1.61 Joint Know-How

The term “Joint Know-How” shall mean Know-How that is made jointly by the
Parties or their Affiliates or their Sublicensees in connection with any
activity carried out pursuant to this Agreement.

 

1.62 Joint Patent Rights

The term “Joint Patent Rights” shall mean all Patent Rights Covering a Joint
Invention or an Inovio Invention jointly owned by Inovio and Roche.

 

1.63 JSC

The term “JSC” shall mean, as applicable, one or both of the joint steering
committees described in Article 4.

 

1.64 Know-How

The term “Know-How” shall mean data, knowledge and information, including
materials, samples, chemical manufacturing data, toxicological data,
pharmacological data, preclinical data, assays, platforms, formulations,
specifications, quality control testing data, that are necessary or useful for
the discovery, manufacture, development or commercialization of Products.

 

1.65 Net Sales

The term “Net Sales” shall mean, for a Product in a particular period, the
amount calculated by subtracting from the Sales of such Product for such period:
(i) a lump sum deduction of four percent (4%) of Sales in lieu of those
deductions that are not accounted for on a Product-by-Product basis (e.g.,
freight, postage charges, transportation insurance, packing materials for
dispatch of goods, custom duties); (ii) uncollectible amounts accrued during
such period based on a proportional allocation of the total bad debts accrued
during such period and not already taken as a gross-to-net deduction in
accordance with the then currently used IFRS in the calculation of Sales of such
Product for such period; (iii) credit card charges (including processing fees)
accrued during such period on such Sales and not already taken as a gross-to-net
deduction in accordance with the then currently used IFRS in the calculation of
Sales of such Product for such period; and (iv) government mandated fees and
taxes and other government charges accrued during such period not already taken
as a gross-to-net deduction in accordance with the then currently used IFRS in
the calculation of Sales of such Product for such period, including, for
example, any fees, taxes or other charges that become due in connection with any
healthcare reform, change in government pricing or discounting schemes, or other
action of a government or regulatory body.

 

1.66 Oncology Product

The term “Oncology Product” shall mean a 5150 Product or an RC Product.

 

1.67 Option Period

The term “Option Period” shall mean the period of time beginning on the
Effective Date and continuing until six (6) months after Roche receives a final
report following expiration or termination of the Oncology Research Program.

 

1.68 Option Right

The term “Option Right” shall mean the option right granted to Roche in
Section 3.4.1 of this Agreement.

 

- 14 -

--------------------------------------------------------------------------------

1.69 Orphan Drug Product

The term “Orphan Drug Product” shall mean, with respect to a given Product sold
in a given country of the Territory by Roche, its Affiliate or Sublicensee, a
product sold by a Third Party in such country that is approved as an orphan drug
under the Orphan Drug Action of 1983, as amended (or successor law or
regulation), or equivalent regulatory approval granted by another Regulatory
Authority.

 

1.70 Party

The term “Party” shall mean Inovio or Roche, as the case may be, and “Parties”
shall mean Inovio and Roche collectively.

 

1.71 Patent Rights

The term “Patent Rights” shall mean all rights under any patent or patent
application, in any country of the Territory, including any patents issuing on
such patent application, and further including any substitution, extension or
supplementary protection certificate, reissue, reexamination, renewal, division,
continuation or continuation-in-part of any of the foregoing.

 

1.72 Phase I Study

The term “Phase I Study” shall mean a human clinical trial in any country that
would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from
time to time, and the foreign equivalent thereof.

 

1.73 Phase II Study

The term “Phase II Study” shall mean a human clinical trial, for which the
primary endpoints include a determination of dose ranges and/or a preliminary
determination of efficacy in patients being studied as described in 21 C.F.R. §
312.21(b) (FDCA), as amended from time to time, and the foreign equivalent
thereof.

 

1.74 Phase III Study

The term “Phase III Study” shall mean a human clinical trial that is
prospectively designed to demonstrate statistically whether a product is safe
and effective for use in humans in a manner sufficient to obtain regulatory
approval to market such product in patients having the disease or condition
being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time
to time, and the foreign equivalent thereof.

 

1.75 Product

The term “Product” shall mean any product that is a 5150 Product, RC Product,
and/or HBV Product, regardless of its finished form or formulation or dosage. A
Product may optionally include one or more Adjuvants. Product does not include
the Delivery Device.

 

1.76 RC Product

The term “RC Product” means a product containing or comprising a vaccine first
reduced to practice under the Oncology Research Collaboration, which is directed
to an RC Target for which Roche has exercised its Option Right and does not
contain a DNA Plasmid that encodes for the engineered PSA and/or PSMA encoded by
the Inovio DNA vaccine known as INO-5150.

 

1.77 Regulatory Approval

The term “Regulatory Approval” shall mean any approvals (including pricing and
reimbursement approvals), licenses, registrations or authorizations by
Regulatory Authority, necessary for the manufacture and sale of a Product in the
Field in a regulatory jurisdiction in the Territory.

 

- 15 -

--------------------------------------------------------------------------------

1.78 Regulatory Authority

The term “Regulatory Authority” shall mean any national, supranational (e.g.,
the European Commission, the Council of the European Union, the European
Medicines Agency), regional, state or local regulatory agency, department,
bureau, commission, council or other governmental entity including the FDA, in
each country involved in the granting of Regulatory Approval for the Product.

 

1.79 Research Plan

The term “Research Plan” shall mean the plans of research and preclinical
development that is current and agreed as of the Effective Date, outlining the
work expected to be performed by Inovio and Roche, as such plan may be updated
from time to time as provided in this Agreement. There shall be two (2) Research
Plans: (i) Oncology Research Plan, and (ii) HBV Research Plan.

 

1.80 Research Program

The term “Research Program” shall mean the activities undertaken by the Parties
pursuant to a Research Plan to identify and preclinically develop DNA vaccines,
and such other activities as the Parties may agree in writing. There are
envisaged two (2) Research Programs: (i) an Oncology Research Program, and
(ii) an HBV Research Program. As used herein, the term “Research Program” shall
be deemed to mean either or both the Oncology Research Program and the HBV
Research Program, as applicable.

 

1.81 Roche Group

The term “Roche Group” shall mean collectively Roche, its Affiliates and its
Sublicensees.

 

1.82 Roche IP Rights

The term “Roche IP Rights” shall mean the Roche Know-How and Roche Patent
Rights.

 

1.83 Roche Know-How

The term “Roche Know-How” shall mean all Know-How that Roche Controls during the
Agreement Term and which is necessary for the development or commercialization
of Products.

 

1.84 Roche Patent Rights

The term “Roche Patent Rights” shall mean all Patent Rights Covering a Product
or Improvements to Inovio Background Technology that Roche Controls (excluding
via licenses granted to Roche from Inovio under this Agreement) during the
Agreement Term. For purposes of clarity, the Patent Rights identified in
Appendix 1.84 are specifically excluded from the Roche Patent Rights.

 

1.85 Royalty Term

The term “Royalty Term” shall mean, with respect to a Product and for a given
country, the period of time commencing on the date of First Commercial Sale of
the Product in such country and ending on the later of the date that is (a) ten
(10) years after the date of the First Commercial Sale of the Product in such
country, or (b) the expiration of the last to expire Inovio Patent Right or
Joint Patent Right in such country Covering the use, import, offering for sale,
or sale of the Product in such country. With regard to the calculation of the
ten (10) year period, the EU shall be considered as one country, provided there
is a centralized EMA regulatory filing.

 

- 16 -

--------------------------------------------------------------------------------

1.86 Sales

The term “Sales” shall mean, for a Product in a particular period, the sum of
(i) and (ii):

i) the amount stated in Roche “Sales” line of its externally published audited
financial statements with respect to such Product for such period (excluding
sales to any Sublicensees that are not Affiliates of Roche). This amount
reflects the gross invoice price at which such Product was sold or otherwise
disposed of (other than for use as clinical supplies or free samples) by Roche,
its Affiliates and Group Sublicensees to such Third Parties (excluding sales to
any Sublicensees that are not Affiliates of Roche) in such period reduced by
gross-to-net deductions, if not previously deducted from such invoiced amount,
taken in accordance with the then currently used IFRS.

By way of example, the gross-to-net deductions taken in accordance with IFRS as
of the Effective Date include the following:

 

  a) credits, reserves or allowances granted for (i) damaged, outdated,
returned, rejected, withdrawn or recalled Product, (ii) wastage replacement and
short-shipments; (iii) billing errors and (iv) indigent patient and similar
programs (e.g., price capitation);

 

  b) governmental price reductions and government mandated rebates;

 

  c) chargebacks, including those granted to wholesalers, buying groups and
retailers;

 

  d) customer rebates, including cash sales incentives for prompt payment, cash
and volume discounts; and

 

  e) taxes, duties and any other governmental charges or levies imposed upon or
measured by the import, export, use, manufacture or sale of a Product (excluding
income or franchise taxes).

For the purpose of clarity, sales by Roche and its Affiliates to any Third Party
Sublicensee and Group Sublicensee shall be excluded from “Sales”.

ii) for Sublicensees, excluding Compulsory Sublicensees, that are not Roche
Affiliates, the sales amounts reported to Roche and its Affiliates in accordance
with the Sublicensee’s contractual terms and their then-currently used
accounting standards. Sales under a Compulsory Sublicense shall be excluded from
Sales, and instead shall be addressed in accordance with Section 6.6.2.7.

 

1.87 Sphergen Cross-License

The term “Sphergen Cross-License” shall mean the agreement between Sphergen,
having its registered office at Genopole Enterprise 4 rue Pierre Fontaine 91058
Evry cedex, and Genetronics, Inc., a wholly owned subsidiary of Inovio, dated
May 3, 2006, as amended.

 

1.88 Sublicensee

The term “Sublicensee” shall mean an entity to which Roche or its Affiliates
have licensed rights pursuant to this Agreement.

 

1.89 Territory

The term “Territory” shall mean all countries of the world.

 

- 17 -

--------------------------------------------------------------------------------

1.90 Third Party

The term “Third Party” shall mean a person or entity other than (i) Inovio or
any of its Affiliates or (ii) a member of the Roche Group.

 

1.91 Third Party Product

The term “Third Party Product” shall mean a Bioequivalent Product or Orphan Drug
Product.

 

1.92 UPenn Agreement

The term “UPenn Agreement” shall mean the agreement between VGX Pharmaceuticals,
Inc. (a fully owned subsidiary of Inovio) and the Trustees of the University of
Pennsylvania dated April 16, 2007, as amended.

 

1.93 UPenn Patent Rights

The term “UPenn Patent Rights” shall mean all Patent Rights Controlled by Inovio
by virtue of the UPenn Agreement.

 

1.94 US

The term “US” shall mean the United States of America and its territories and
possessions.

 

1.95 US$

The term “US$” shall mean US dollars.

 

1.96 Valid Claim

The term “Valid Claim” shall mean, as applicable, a claim in any (i) unexpired
and issued patent encompassed by the Inovio Patent Rights that has not been
disclaimed, revoked or held invalid by a final nonappealable decision of a court
of competent jurisdiction or government agency or (ii) pending patent
application in any country of the Territory that (a) is on file with the
applicable patent office and has shown evidence of reasonably consistent
activity to advance to issuance of a patent and (b) which application is on file
with the applicable patent office for no more than seven (7) years from the
earliest date to which the patent application claims its earliest priority.

 

1.97 VGXI Supply Agreement

The term “VGXI Supply Agreement” shall mean the agreement among VGXI, Inc., VGX
International, Inc., and VGX Pharmaceuticals, Inc. dated June 28, 2008, as
amended.

 

1.98 Additional Definitions

Each of the following definitions is set forth in the Section of this Agreement
indicated below:

 

Definition

  

Section

5150 Development Support Payments    5.1.2.1 Accounting Period    7.1 Alliance
Director    4.7 Bankruptcy Code    16.1 Breaching Party    15.2.1 CAPA Plan   
5.4.1 Chairperson    4.2 Decision Period    10.5 Development and
Commercialization License    3.2 Device Supply Agreements    5.4.2 Disclosing
Party    1.18 DSRP Report    7.2

 

- 18 -

--------------------------------------------------------------------------------

Definition

  

Section

EEC    1.52 EH&S    5.5 Enabling Technologies    1.31 HBV Development and
Commercialization License    3.4.4 H-W Suit Notice    10.9 Improvements to
Inovio Background Patent Rights    3.3 Indemnified Party    12.3 Indemnifying
Party    12.3 Initiating Party    10.5 Joint Invention    1.59 Members    4.2
Inovio Invention    1.59 Non-Breaching Party    15.2.1 Option Period    1.66
Patent Term Extensions    10.11 Payment Currency    7.5 Peremptory Notice Period
   15.2.1 Product Supply Agreements    5.3.1 Publishing Notice    14.4
Publishing Party    14.4 RC Adjuvant    2.1.3.1 RC Development and
Commercialization License    3.4.3 RC Targets    2.1.3.1 Receiving Party    1.18
Reference Product Sponsor    10.10 Research Term    2.1.6 Roche Invention   
1.59 Samples    15.3.1(a) Sensitive Information    16.2 Settlement    10.5 SPCs
   10.11 Suit Notice    10.5 Termination Product    15.3.1 Third Party Offset   
6.6.2.6

 

2. Research Collaboration

 

2.1 Conduct of the Research Programs

 

2.1.1 Scope

Roche and Inovio shall conduct mutually agreed Research Programs pursuant to the
Research Plans. There shall be an Oncology Research Program and an HBV Research
Program. The activities conducted in connection with the Research Program will
be overseen by the applicable JSC.

 

- 19 -

--------------------------------------------------------------------------------

2.1.2 Diligent Efforts

Roche and Inovio shall each use Commercially Reasonable Efforts to perform their
respective tasks and obligations in conducting all activities ascribed to it in
the then-current Research Plan, in accordance with the time parameters set forth
therein.

 

2.1.3 Research Plans

The appropriate JSC will agree upon any updates or changes to the relevant
Research Plan, including required deliverables from Inovio. Each Research Plan
will set forth (i) the scope of the relevant Research Program and the resources
that will be dedicated to the activities contemplated within the scope of the
relevant Research Program, including the responsibilities of each Party,
(ii) specific objectives for each year, which objectives will be updated or
amended, as appropriate, by the appropriate JSC as research progresses,
(iii) detailed budgets for such activities, (iv) Inovio personnel assigned to
the core team and the assignment of other Inovio personnel from specified
functional areas, and (v) any activities to be performed by Third Party
contractors. The appropriate JSC shall review the relevant Research Plan on an
ongoing basis and may amend the Research Plan. Any such changes shall be
reflected in written amendments to the relevant Research Plan

 

  2.1.3.1 Oncology Research Plan

The objective of the Oncology Research Plan is to establish a research
collaboration on up to five (5) Antigen targets (“RC Targets”) with primary
activity in oncology indications and up to two (2) Adjuvants (“RC Adjuvants”) to
be nominated by Roche and mutually agreed by the Parties. If, during the
Research Term, the Parties discontinue work on one or more RC Targets or RC
Adjuvants, then Roche may nominate an Antigen target or Adjuvant to replace each
discontinued RC Target or Adjuvant, as applicable. Roche and Inovio shall
collaborate to develop DNA vaccines directed to the RC Targets in accordance
with the mutually agreed Oncology Research Plan.

 

  2.1.3.2 HBV Research Plan

The objective of the HBV Research Plan is to further research and develop the
INO-1800 DNA vaccine and potentially backup DNA vaccines based thereon.

 

  2.1.3.3 Funded Inovio FTEs.

‘’’’’’’’’’’’’’ ‘’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’ ‘’’’’’’
‘’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’ ‘’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’ of the
research and other activities for which Inovio is responsible under the Oncology
Research Plan. Each individual included in the funded FTEs shall possess a
bachelor’s degree or higher in a relevant scientific discipline and shall be
experienced in the type of research or other activities to be performed by such
individual under the Research Plan. At Roche’s request, Inovio shall provide
resumes or curricula vitae for funded FTEs in order for Roche to ensure such
individuals have the appropriate qualifications.

 

  2.1.3.4 Third Party Contractors.

If specified in the Research Plan, or agreed to in writing by the JSC, Inovio
may use Third Party contractors to perform Inovio’s activities under the
Research Plan, provided Inovio shall ensure such activities are subject to a
written agreement under which such third party contractor assigns and/or
exclusively licenses all right, title and interest in the results of such
activities to Inovio.

 

2.1.4 Personnel

The Inovio personnel assigned to work on the Research Plan shall comprise a core
team which will be dedicated to such plan. Inovio shall use the collaboration
funding it receives from Roche

 

- 20 -

--------------------------------------------------------------------------------

solely to carry out its activities under a Research Program in accordance with
this Agreement. Roche, upon request of Inovio and at Roche’s discretion, may
provide in-kind contributions to Inovio.

 

2.1.5 Exclusivity

Inovio shall work exclusively with Roche on the RC Targets and Products during
the Research Term and, if applicable, the Option Period. For clarity, RC Target
exclusivity extends beyond the uniquely identifiable gene product encoded by a
DNA Plasmid to post-translational modifications or variants of such product, as
well as proteins, protein-constructs, peptides and other immunogens derived
therefrom. This Section 2.1.5 shall not limit Inovio’s right to use the Delivery
Device or Enabling Technologies in connection with other products that are not
Products.

 

2.1.6 Research Term

Each Research Program shall commence on the Effective Date and shall continue
until (i) for the Oncology Research Program, three (3) years unless terminated
earlier in accordance with the other provisions of this Agreement, or (ii) for
the HBV Research Program, until the completion or cessation of the activities
under the HBV Research Plan. The duration of each Research Program is its
research term (“Research Term”).

 

2.2 Records; Reports

 

2.2.1 Progress Reports

At least quarterly during the Research Term for each Research Program, Inovio
shall prepare and provide to the JSC a detailed written report summarizing the
progress of the work performed by Inovio in the course of the Research Program
during the preceding Calendar Quarter. Within sixty (60) days after completion
or cessation of the HBV Research Program, Inovio shall provide to Roche a final
written report summarizing its activities under the HBV Research Program,
including any material data and information generated in the course of the HBV
Research Program not previously provided to Roche. With regard to the Oncology
Research Program, with respect to each RC Target, within sixty (60) days after
completion or cessation of the Oncology Research Plan activities related to such
RC Target, Inovio will provide to Roche a written final report summarizing its
activities under the Oncology Research Program related to such RC Target,
including any material data and information generated in the course of the
Oncology Research Program not previously provided to Roche.

 

2.2.2 Materials

During the Research Term and, if applicable, the Option Period, at Roche’s
request, Inovio will provide Roche with reasonable quantities of those vaccines
or other materials generated during the Oncology Research Program to allow Roche
to conduct activities related to the Research Program and as necessary or useful
for determining whether to exercise its option for a RC Target.

 

2.2.3 Research Records

Each Party shall maintain records of the Research Programs (or cause such
records to be maintained) in sufficient detail and in good scientific manner as
will properly reflect all work done and results achieved by or on behalf of such
Party in the performance of the Research Programs. All laboratory notebooks
shall be maintained for no less than the term of any Patent Rights issuing
therefrom.

 

- 21 -

--------------------------------------------------------------------------------

3. Licenses and Exclusive Option Right

 

3.1 Research Cross License

Each Party grants to the other Party, on a Research Program-by-Research Program
basis, a non-exclusive right and license under Know-How and Patent Rights
Controlled by such Party and that are necessary or useful for performing the
activities assigned under the applicable Research Plan.

 

3.2 5150 Product Development and Commercialization License

Inovio hereby grants to Roche:

a) a sole and exclusive (even as to Inovio), worldwide, irrevocable,
royalty-bearing right and license (with the right to sublicense through multiple
tiers) under the Inovio IP Rights and Inovio’s interest in the Joint Patent
Rights and Joint Know-How to research, have researched, develop, have developed,
register, have registered, use, have used, make, have made import, have
imported, export, have exported, market, have marketed, distribute, have
distribute, offer to sell, sell and have sold 5150 Products in the Field in the
Territory; and

b) an exclusive, worldwide, irrevocable, royalty-free right and license (with
the right to sublicense through multiple tiers) under the Inovio IP Rights and
Inovio’s interest in the Joint Patent Rights and Joint Know-How to research,
have researched, develop, have developed, register, have registered, use, have
used, make, have made import, have imported, export, have exported, market, have
marketed, distribute, have distribute, offer to sell, sell and have sold
Delivery Devices and Enabling Technologies for the sole purpose of use in
connection with 5150 Product(s) in the Field in the Territory; and

c) a sole and exclusive (even as to Inovio), worldwide, irrevocable,
royalty-free right and license (with the right to sublicense through multiple
tiers) under the Inovio Patent Rights and Inovio Know-How and Inovio’s interest
in the Joint Patent Rights and Joint Know-How to research, have researched,
develop, have developed, register, have registered, use, have used, make, have
made import, have imported, export, have exported, market, have marketed,
distribute, have distribute, offer to sell, sell and have sold Companion
Diagnostics for 5150 Products in the Field in the Territory.

d) Roche hereby grants to the Inovio a non-exclusive right and license under
Know-How and Patent Rights Controlled by Roche and that are necessary or useful
for performing the activities assigned to Inovio under the 5150 Product
Development Plan.

 

3.3 License to Inovio for Improvements to Inovio Background Technology

Roche hereby grants to Inovio a non-exclusive, worldwide, irrevocable, sub
licensable license under those patent rights Controlled by Roche that claim a
Roche Invention, to make, use, sell, offer for sale and import inventions that
are both (i) improvements to inventions Covered by Device Patents and Enabling
Technology Patents within the Inovio Background Patent Rights and
(ii) conceived, reduced to practice, or otherwise first made, discovered, or
created pursuant to the activities conducted under a Research Program or
pursuant to a Development Plan by Roche or its Affiliates, and/or their
employees, contractors or agents (“Improvements to Inovio Background Patent
Rights”). This license shall be royalty-free unless Roche has expended more than
‘’’’’’’’’’’ ‘’’’’’’’’’’’’’ ‘’’’’’’ ‘’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ in the development of the Delivery
Device, in which case the license shall be on commercially reasonable terms to
be negotiated in good faith by the Parties. Inovio shall have the right to use
Improvements to Inovio Background

 

- 22 -

--------------------------------------------------------------------------------

Patent Rights in Third Party collaborations provided that ‘’’’’
‘’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’ ‘’’’’’’’’’’ ‘’’’’
‘’’’’’’’’’’’’’ ‘’’ ‘’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’ ‘’’’’’’’’’
‘’’’’ ‘’’’’’’’’’’’ ‘’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’ ‘’’’’’’’’’’’’’’’’’’ ‘’’’’
‘’’’’’’’’ ‘’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’
‘’’’’’ ‘’’’’ ‘’’’’’ ‘’’’’’’’’’’’’’’ ‘’’’ ‘’’’’’’’’’ ‘’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’ ‘’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’ ‘’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’ ‘’’’’
‘’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’ ‘’’’’’’’’’ ‘’’’’’ ‘’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’ ‘’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’ ‘’’’’’’
‘’’’’’’’’’’’’ ‘’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’ ‘’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’ ‘’’’’’’’’’ ‘’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’ ‘’’’’’’’’ ‘’’’’’’’’’’ ‘’’’’’’’’’’’’’’’
‘’’’’’’’’’ ‘’’’’’’’’’’ ‘’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’ ‘’’’’’’ ‘’’’’’’’’’’’’’’ ‘’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’ ‘’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’
Notwithstanding anything to the contrary, Improvements to Inovio Background
Patent Rights exclude the right to research, have researched, develop, have
developed, register, have registered, use, have used, make, have made import,
have imported, export, have exported, market, have marketed, distribute, have
distribute, offer to sell, sell and have sold Products and Companion
Diagnostics.

 

3.4 Option Right

 

3.4.1 Grant of Option Right

For each RC Target included under the Oncology Research Program, Inovio hereby
grants to Roche during the Option Period an exclusive right to obtain the RC
Development and Commercialization License set forth in Section 3.4.3 (the
“Option Right”).

 

3.4.2 Exercise of Option Right

On a RC Target-by-RC Target basis, Roche shall have the right to exercise the
Option Right at any time during the Option Period by giving a written notice to
Inovio indicating the RC Target(s) (including any associated Product(s))
selected by Roche to be included in the RC Development and Commercialization
License. At the end of the exclusive Option Period (including any extensions
thereof), Roche’s Option Right shall expire.

 

3.4.3 RC Development and Commercialization License

For any RC Target(s) that Roche selects to exercise its Option Right in
accordance with Section 3.4.2, which upon exercise, Products directed to each
such RC Target then shall be referred to as an RC Product; Inovio hereby grants
to Roche:

a) a sole and exclusive (even as to Inovio), worldwide, irrevocable,
royalty-bearing right and license (with the right to sublicense through multiple
tiers) under the Inovio IP Rights and Inovio’s interest in the Joint Patent
Rights and Joint Know-How to research, have researched, develop, have developed,
register, have registered, use, have used, make, have made import, have
imported, export, have exported, market, have marketed, distribute, have
distribute, offer to sell, sell and have sold (i) such RC Products and/or
(ii) Products directed to such RC Target, in each case (i) and (ii) in the Field
in the Territory; and

b) an exclusive, worldwide, irrevocable, royalty-free right and license (with
the right to sublicense through multiple tiers) under the Inovio Patent Rights
and Inovio Know-How and Inovio’s interest in the Joint Patent Rights and Joint
Know-How to research, have researched, develop, have developed, register, have
registered, use, have used, make, have made import, have imported, export, have
exported, market, have marketed, distribute, have distribute, offer to sell,
sell and have sold Delivery Devices and Enabling Technologies for the sole
purpose of use in connection with (i) such RC Product(s) and/or (ii) Products
directed to such RC Target in each case (i) and (ii) in the Field in the
Territory; and

 

- 23 -

--------------------------------------------------------------------------------

c) a sole and exclusive (even as to Inovio), worldwide, irrevocable,
royalty-free right and license (with the right to sublicense through multiple
tiers) under the Inovio IP Rights and Inovio’s interest in the Joint Patent
Rights and Joint Know-How to research, have researched, develop, have developed,
register, have registered, use, have used, make, have made import, have
imported, export, have exported, market, have marketed, distribute, have
distribute, offer to sell, sell and have sold Companion Diagnostics for (i) such
RC Products and/or (ii) Products directed to such RC Target, in each case
(i) and (ii) in the Field in the Territory (a, b, and c, collectively, the “RC
Development and Commercialization License”).

 

3.4.4 HBV Development and Commercialization License

Inovio hereby grants to Roche:

a) a sole and exclusive (even as to Inovio), worldwide, irrevocable,
royalty-bearing right and license (with the right to sublicense through multiple
tiers) under the Inovio IP Rights and Inovio’s interest in the Joint Patent
Rights and Joint Know-How to research, have researched, develop, have developed,
register, have registered, use, have used, make, have made, import, have
imported, export, have exported, market, have marketed, distribute, have
distribute, offer to sell, sell and have sold HBV Products in the Field in the
Territory; and

b) an exclusive, worldwide, irrevocable, royalty-free right and license (with
the right to sublicense through multiple tiers) under the Inovio IP Rights and
Inovio’s interest in the Joint Patent Rights and Joint Know-How to research,
have researched, develop, have developed, register, have registered, use, have
used, make, have made import, have imported, export, have exported, market, have
marketed, distribute, have distribute, offer to sell, sell and have sold
Delivery Devices and Enabling Technologies for the sole purpose of use in
connection with HBV Product(s) in the Field in the Territory; and

c) a sole and exclusive (even as to Inovio), worldwide, irrevocable,
royalty-free right and license (with the right to sublicense through multiple
tiers) under the Inovio IP Rights and Inovio’s interest in the Joint Patent
Rights and Joint Know-How to research, have researched, develop, have developed,
register, have registered, use, have used, make, have made import, have
imported, export, have exported, market, have marketed, distribute, have
distribute, offer to sell, sell and have sold Companion Diagnostics for HBV
Products in the Field in the Territory (a, b, and c, collectively, the “HBV
Development and Commercialization License”).

 

3.5 Retained Rights

At the end of the Option Period, Inovio shall retain all rights under Inovio’s
interest in the Inovio IP Rights; and Inovio’s interest in the Joint Patent
Rights and Joint Know-How to any RC Targets generated by Inovio under the
Oncology Research Program and not selected by Roche in exercising its Option
Right.

 

4. Governance

 

4.1 Joint Steering Committee

Within thirty (30) days after the Effective Date of this Agreement, the Parties
shall establish a JSC for each of the Oncology Research Program and the HBV
Research Program to oversee the research activities under this Agreement. If a
Research Program moves to development, and the Parties agree to conduct joint
development activities, then the JSC for such Research Program shall continue
for the duration of any joint development activities related to such development
activities. For clarity, the JSC shall oversee the presently planned Phase I
Study and the timing of the transition of clinical activities to Roche.

 

- 24 -

--------------------------------------------------------------------------------

4.2 Members

Each JSC shall be composed of an equal number of persons (“Members”) from each
Party. Roche and Inovio each shall appoint Members with appropriate seniority
and functional expertise. The number of Members on the JSC shall be decided by
the mutual agreement of the Parties based on the needs of the JSC. Each Party
may replace any of its Members and appoint a person to fill the vacancy arising
from each such replacement. A Party that replaces a Member shall notify the
other Party at least ten (10) days prior to the next scheduled meeting of the
JSC. Both Parties shall use Commercially Reasonable Efforts to keep an
appropriate level of continuity in representation. Both Parties may invite a
reasonable number of additional experts and/or advisors to attend part or the
whole JSC meeting with prior notification to the JSC. Members may be represented
at any meeting by another person designated by the absent Member. The JSC shall
be chaired by a Roche Member (“Chairperson”).

 

4.3 Responsibilities of the JSC

Each JSC shall have the responsibility and authority to:

 

a) approve the Research Plan and Development Plan, if applicable, and associated
budgets;

 

b) revise and approve any revisions to the Research Plan and Development Plan,
if applicable, and associated budgets;

 

c) review and oversee the Research Program and execution of the Research Plan,
and the development activities under any agreed upon Development Plan, if
applicable;

 

d) revise and approve any revisions to the CAPA Plan;

 

e) review and oversee the execution of the CAPA Plan, and the implementation of
any activities under the CAPA Plan and subsequent auditing and rectifying
activities, if applicable;

 

f) discuss in-kind contributions from Roche;

 

g) review all data arising out of the Research Program or joint development
activities;

 

h) review manufacturing activities and plans directed to developing
manufacturing capability and capacity;

 

i) monitor and advise on activities related to the development, manufacture and
supply of the Delivery Device;

 

j) make decisions on the Research Plan and Development Plan, if applicable, and
associated budgets;

 

k) monitor and implement the transfer of Inovio Know-How to Roche;

 

l) create subcommittees to the extent necessary for the governance and operation
of the activities under this Agreement; and

 

m) attempt to resolve any disputes on an informal basis.

The JSC shall have no responsibility and authority other than that expressly set
forth in this section.

 

4.4 Meetings

The Chairperson or his/her delegate shall be responsible for sending invitations
and agendas for all JSC meetings to all Members at least ten (10) days before
the next scheduled meeting of

 

- 25 -

--------------------------------------------------------------------------------

the JSC. The venue for the meetings shall be agreed by the JSC. The JSC shall
hold meetings at least four (4) times per Calendar Year, either in person or by
tele-/video-conference, and in any case as frequently as the Members of the JSC
may agree shall be necessary.

 

4.5 Minutes

The Chairperson shall be responsible for designating a Member to record in
reasonable detail and circulate draft minutes of JSC meetings to all members of
the JSC for comment and review within twenty (20) days after the relevant
meeting. The Members of the JSC shall have ten (10) days to provide comments.
The Party preparing the minutes shall incorporate timely received comments and
distribute finalized minutes to all Members of the JSC within thirty-five
(35) days of the relevant meeting. The Chairperson shall approve the final
version of the minutes before its distribution.

 

4.6 Decisions

 

4.6.1 Decision Making Authority

The JSC shall decide matters within its responsibilities set forth in
Section 4.3.

 

4.6.2 Consensus; Good Faith

The Members of the JSC shall act in good faith to cooperate with one another and
seek agreement with respect to issues to be decided by the JSC. The Parties
shall endeavor to make decisions by consensus.

 

4.6.3 Failure to Reach Consensus

If the JSC is unable to decide a matter by consensus, then

a) Roche shall have the final decision authority on any matter with respect to
Products that are subject to a Development and Commercialization License; and

b) Roche shall have the final decision authority on any matter under a Research
Plan or Development Plan that Roche is funding; and

c) all other matters shall be referred to the Chief Executive Officer of Inovio
or equivalent position or his/her nominee and the Head of Roche Partnering or
equivalent position or his/her nominee for resolution, who together shall use
reasonable and good faith efforts to reach a decision by consensus within thirty
(30) days after the date such matter is referred to them. If the Parties still
fail to reach a decision within such thirty (30) days, then the final decision
shall be Roche’s, which shall be exercised in good faith. Any such decision
shall constitute a decision of the JSC.

 

4.7 Alliance Director

Each Party shall appoint one person to be the point of contact within each Party
with responsibility for facilitating communication and collaboration between the
Parties (each, an “Alliance Director”). The Alliance Directors shall facilitate
resolution of potential and pending issues and potential disputes to enable the
JSC to reach consensus and avert escalation of such issues or potential
disputes.

 

4.8 Limitations of Authority

The JSC shall have no authority to amend or waive any terms of this Agreement.

 

- 26 -

--------------------------------------------------------------------------------

4.9 Expenses

Each Party shall be responsible for its own expenses including travel and
accommodation costs incurred in connection with the JSC.

 

4.10 Lifetime

The JSC shall exist during the Option Period and for so long as the Parties
agree to conduct joint development activities.

 

5. Clinical Development and Commercialization

 

5.1 Development

 

5.1.1 Standards for Development

Inovio shall conduct all development activities assigned to it under this
Agreement using Commercially Reasonable Efforts in compliance with all
applicable laws and regulations. If Inovio files an IND for any clinical study
contemplated by this Agreement, then Inovio shall (i) provide Roche with an
opportunity to review the IND prior to Inovio’s initial submission and (ii) make
any reasonable revision or amendment to the IND requested by Roche. At the
conclusion of any such clinical study, Inovio shall prepare and deliver to Roche
a clinical study report detailing the data generated and summarizing the results
of such clinical study. Inovio shall keep Roche informed of all communications
with Regulatory Authorities and any data and results associated with all such
clinical studies, whether generated in such study or peripheral to such study.
At Roche’s written request, Inovio shall transfer those INDs it has filed for
the clinical studies contemplated by this Agreement to Roche and thereafter
Roche shall be responsible for running the study in cooperation with Inovio and
the appropriate JSC. At Roche’s request and expense, Inovio shall cooperate and
assist Roche as reasonably requested in providing feedback or performing agreed
upon activities in accordance with the relevant Development Plan.

 

5.1.2 Development of Oncology Products

 

  5.1.2.1 Development of 5150 Product

Inovio shall be responsible for filing the mutually agreed IND for the Inovio
5150 Trial and for operational execution of the Inovio 5150 Trial in cooperation
with Roche via the JSC. If, after filing the IND, additional toxicology studies
are required for the 5150 Product, then Inovio shall conduct these studies, in
cooperation with Roche, at Inovio’s expense. Roche shall reimburse Inovio for
(a) actual costs and expenses incurred for activities performed in the conduct
of the Inovio 5150 Trial, provided that in no event shall the total amount
reimbursed by Roche exceed one hundred ten percent (110%) of the total budget
amount that is current and agreed as of the Effective Date, or as otherwise
approved by the JSC, for the conduct of the Inovio 5150 Trial; and (b) costs and
expenses actually incurred by Inovio in the conduct of any other development
activities expressly authorized by the JSC under the 5150 Product Development
Plan and set forth in the budget provided that in no event shall the total
amount reimbursed by Roche exceed one hundred ten percent (110%) of such budget
(which costs will not include the aforementioned toxicology study) ((a) and
(b) together, the “5150 Development Support Payments”).

 

  5.1.2.2 Development of RC Products

Unless otherwise agreed by the Parties in writing, Roche shall be solely
responsible, at its own expense, for filing the IND and for all other
development and commercialization activities concerning RC Products, including
conducting clinical trials, regulatory submissions, sales and marketing. At
Roche’s request and expense, Inovio shall cooperate and assist Roche as
reasonably requested in the clinical development of such Products in accordance
with the relevant Development Plan.

 

- 27 -

--------------------------------------------------------------------------------

5.1.3 Development of HBV Products

Unless otherwise agreed by the Parties in writing, Roche shall be solely
responsible, at its own expense, for all clinical and commercial development and
commercialization activities concerning HBV Products, including conducting
clinical trials, regulatory submissions, sales and marketing, except Inovio
shall be responsible for filing the mutually agreed IND for the first INO-1800
Phase I Study, and for operational execution of the first INO-1800 Phase I Study
in cooperation with Roche via the JSC. Roche shall reimburse Inovio for
(a) actual costs and expenses incurred for activities performed in the conduct
of the first INO-1800 Phase I Study and approved by the JSC together with a
budget, provided that in no event shall the total amount reimbursed by Roche
exceed one hundred ten percent (110%) of such budget; and (b) costs and expenses
actually incurred by Inovio in the conduct of any other development activities
expressly authorized by the JSC under the HBV Development Plan and its
associated budget, provided that in no event shall the total amount reimbursed
by Roche exceed one hundred ten percent (110%) of such budget.

 

5.2 Regulatory Responsibility

Except as set forth in Section 5.1.1, Roche, at its sole cost, shall pursue all
regulatory affairs related to Products in the Territory including the
preparation and filing of applications for regulatory approval, as well as any
or all governmental approvals required to develop, have developed, make, have
made, use, have used, manufacture, have manufactured, import, have imported,
sell and have sold Products. Roche shall be responsible for pursuing, compiling
and submitting all regulatory filing documentation, and for interacting with
regulatory agencies, for all Products in the Territory. Roche or its Affiliates
shall own and file in their discretion all regulatory filings and regulatory
approvals for all Products in the Territory. Roche, at its sole cost, shall
report to appropriate authorities in accordance with local requirements all
adverse events related to use of Products in the Territory.

 

5.3 Supply in General

 

5.3.1 In General

Roche shall have the right to assume any and all manufacturing and supply
responsibilities for Products at its sole discretion. Manufacture by Inovio
pursuant to this agreement may be conducted by Inovio or by Inovio’s Third Party
manufacturer provided (i) such Third Party manufacturer is obligated to supply
in a manner consistent with the terms and conditions of this Agreement and
(ii) Inovio shall be responsible for any breach of these obligations by such
Third Party manufacturer. The Parties anticipate that they and/or the Third
Party manufacturer and/or their Affiliates will enter into additional agreements
that are reasonable and customary in connection with supplying the Products
(“Product Supply Agreements”), including manufacturing and quality agreements.
The Product Supply Agreements shall contain terms and conditions consistent with
this Agreement, in addition to other terms that are reasonable and customary,
including provisions to ensure quality and audit by or on behalf of Roche.

 

5.3.2 Oncology Product Supply

 

  5.3.2.1 Preclinical Supply

Unless otherwise expressly stated in the applicable Research Plan and associated
budget, Inovio shall be responsible, at its own expense, for the preclinical
manufacture (and, if requested or contemplated by the Research Plan, supply to
Roche) of DNA Plasmid (i.e. the active pharmaceutical ingredient), Adjuvant, and
the Delivery Device, for use under the Oncology Research Plan.

 

- 28 -

--------------------------------------------------------------------------------

  5.3.2.2 Early Clinical Supply

 

  5.3.2.2.1 5150 Product

Inovio shall be responsible for the manufacture and supply of the 5150 Product
and the Delivery Device for use in the clinical development of the 5150 Product,
including the completion of the Inovio 5150 Trial. For 5150 Product and Delivery
Device manufactured after the Effective Date, Roche shall reimburse Inovio for
such manufacture and supply at Inovio’s FBMC or the actual amount paid by Inovio
to its current Inovio’s Third Party manufacturer.

 

  5.3.2.2.2 RC Product

At Roche’s Request, Inovio shall be responsible for the manufacture and supply
of DNA Plasmid (i.e. the active pharmaceutical ingredient), Adjuvant, and/or the
Delivery Device to Roche, an Affiliate, or to a Third Party identified by Roche
for use in the clinical development of any RC Product. Such manufacture and
supply shall be provided at Inovio’s FBMC or the actual amount paid by Inovio to
its current Inovio’s Third Party manufacturer.

 

  5.3.2.3 Pivotal Trial and Commercial Supply

Roche shall consider Inovio as a supplier for the commercial manufacture of DNA
Plasmid and/or Adjuvant and/or the Delivery Device, provided that Inovio can
demonstrate that it is able to supply Roche with its commercial requirements on
commercially reasonable terms. If Inovio is not chosen as a supplier for Roche,
and, even if Inovio is chosen as a supplier in order to enable a manufacturing
process for DNA Plasmid, Adjuvant and/or the Delivery Device to Roche, or to an
Affiliate or Third Party identified by Roche, technology transfer activities
will be governed by a technology transfer agreement under commercially
reasonable terms.

 

5.3.3 HBV Product Supply

 

  5.3.3.1 Preclinical Supply

Unless otherwise expressly stated in the applicable Research Plan and associated
budget with regard to external costs, Inovio shall be responsible, at its own
expense, for the preclinical manufacture (and, if requested or contemplated by
the Oncology Research Plan, supply to Roche) of DNA Plasmid (i.e. the active
pharmaceutical ingredient), Adjuvant, and the Delivery Device.

 

  5.3.3.2 Early Clinical Supply

Inovio shall manufacture and supply HBV Product and the Delivery Device for
Roche for use in the clinical development of the HBV Product. Roche shall
reimburse Inovio for such manufacture and supply at Inovio’s FBMC and/or the
actual amount paid by Inovio to its current Inovio’s Third Party manufacturer.

 

  5.3.3.3 Pivotal Trial and Commercial Supply

Roche shall consider Inovio as a supplier for the commercial manufacture of DNA
Plasmid and/or Adjuvant and/or the Delivery Device, provided that Inovio can
demonstrate that it is able to supply Roche with its commercial requirements on
commercially reasonable terms. If Inovio is not chosen as a supplier for Roche,
and, even if Inovio is chosen as a supplier in order to enable a manufacturing
process for DNA Plasmid and the Delivery Device to Roche, or to an Affiliate or
Third Party identified by Roche, technology transfer activities will be governed
by a technology transfer agreement under commercially reasonable terms.

 

- 29 -

--------------------------------------------------------------------------------

5.3.4 Transfer of Manufacturing Technology

At any time during the term, following notice from Roche, (i) Inovio shall use
diligent efforts to transfer to Roche and/or its Affiliates and/or a Third Party
manufacturer designated by Roche, ‘’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’ ‘’’’’’’’’’’’’’’’ ‘’’’’ ‘’’’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’ ‘’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’ ‘’’’’ ‘’’’’’’
‘’’’’’’’’’ ‘’’’’ ‘’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’ ‘’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’ ‘’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’
‘’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’ ‘’’’’’ ‘’’’’’’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’ ‘’’’ ‘’’’’’’’’’’’ ‘’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’ ‘’’’’’’’’’’’’’’ ‘’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’ and
(ii) Inovio shall use diligent efforts to assign or license to Roche and/or its
Affiliates and/or a Third Party manufacturer designated by Roche’’ ‘’’’’
‘’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’ ‘’’’’’’’’’’’’’
‘’’’’’ ‘’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’ ‘’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’ ‘’’’’ ‘’’’’’’’ ‘’’’’’’’’’’ ‘’’’’
‘’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’ ‘’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’ ‘’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’
‘’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’ ‘’’’’’ ‘’’’’’’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’ ‘’’’ ‘’’’’’’’’’’’ ‘’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’ ‘’’’’’’’’’’’’’’’ ‘’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’ to manufacture Product and Delivery Device. In
addition, at Roche’s request Inovio shall use diligent efforts to assist Roche
with obtaining additional manufacturing services from ‘’’’’’’’’’’’’’’’’’
‘’’’’’’’’’’’ ‘’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ for use in the
conduct of clinical trials, ‘’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’ ‘’’’’’
‘’’’’’’’’’’’’’’ ‘’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’ ‘’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’ ‘’’’’’ ‘’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’ ‘’’’’’
‘’’’’’’’’’’’ ‘’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’ ‘’’’’ ‘’’’’’’’’’’’’’’ ‘’’’’ ‘’’’’’’
‘’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’ ‘’’’’’ ‘’’’’’’’’’’ ‘’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’ ‘’’’’ ‘’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’ ‘’’’’
‘’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’ ‘’’’
‘’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’ ‘’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’ ‘’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’ ‘’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’ ‘’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’ ‘’’’
‘’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’ ‘’’’’’’’’ ‘’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’
‘’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’.

 

5.4 Development and Supply of Delivery Devices

 

5.4.1 CAPA Plan. Inovio shall implement and maintain those response and action
items identified in the corrective and preventative action plan that is current
and agreed as of the Effective Date (the “CAPA Plan”). Inovio shall provide
Roche, through the JSC with regular updates on its ongoing compliance with the
CAPA Plan. During any time period in which Inovio is supplying the Delivery
Device to Roche or is optimizing the Delivery Device that will be supplied to
Roche, Roche shall have the right, on reasonable notice to Inovio, to audit
Inovio and any Third Party contractors of Inovio to the extent Roche determines
is necessary to confirm compliance with the CAPA plan.

 

5.4.2 Delivery Device Optimization and Supply by Inovio.

 

  5.4.2.1 Subject to Roche’s options set forth in Section 5.4.3 below, the
Parties currently anticipate that Inovio will be responsible for the further
development and supply to Roche of Delivery Devices that are useful or necessary
to deliver any Product and/or conduct activities under this Agreement. The
Parties or their Affiliates will enter into a separate Delivery Device supply
agreement (“Device Supply Agreements”), including manufacturing and quality
agreements, within six (6) months after the Effective Date outlining the terms
and conditions of the development, manufacturing and supply of the Delivery
Device. The Device Supply Agreement shall contain terms and conditions
consistent with this Agreement, in addition to other terms that are reasonable
and customary, including provisions to ensure quality and audit by or on behalf
of Roche. All costs incurred in such optimization and development shall be
shared equally by Inovio and Roche. Delivery Devices shall be provided (i) for
clinical trial supply, at Inovio’s FBMC and (ii) for commercial supply, at
Inovio’s FBMC plus ‘’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’.

 

- 30 -

--------------------------------------------------------------------------------

  5.4.2.2 Unless Roche opts to internalize development and optimization of the
Delivery Device, commencing on the Effective Date, Inovio will provide Roche
with regular updates on the further development and optimization of the Delivery
Device by Inovio. Updates shall be provided at least every eight (8) weeks and
otherwise at Roche’s request. In addition, on reasonable notice, Inovio shall
allow representatives of Roche (including Third Party consultants) to be on-site
at Inovio to the extent necessary or useful for Roche to monitor and comment on
such further development and optimization. Inovio shall endeavor to include or
promptly update a Roche representative in Inovio’s meetings and discussions
around the further development of the Delivery Device such that Roche has a
meaningful opportunity to understand the current status and further timelines
for such development

 

5.4.3 Roche Options for Development and Supply of Delivery Devices. Roche shall
have the right, at any time, in its sole discretion, to choose from the
following two (2) options with regard to the development and supply of the
Delivery Device. Until Roche exercises such right, Inovio shall be responsible
for the manufacture and supply of Delivery Devices. Under either option, the
Parties or their Affiliates will promptly enter into a separate Delivery Device
supply agreement (which agreement shall supersede and replace the then current
Device Supply Agreement) outlining the terms and conditions of the development,
manufacturing and supply of the Delivery Device The Device Supply Agreement
shall contain terms and conditions consistent with this Agreement, in addition
to other terms that are reasonable and customary, including provisions to ensure
quality and audit by or on behalf of Roche.

 

  5.4.3.1 Option 1: At any time, in its sole discretion and at no additional
upfront cost, Roche may opt to co-develop the Delivery Device for supply to
Roche hereunder. Each Party shall bear its own expenses related to such
co-development. The Parties will share equally any Third Party costs incurred
after Roche exercises such option. Each Party shall have the right to oversee
and to comment on such development and manufacturing activities, which comments
shall be considered in good faith. While the Parties will endeavor to make
decisions by consensus, Roche shall retain final decision making authority.
Co-developed Delivery Devices supplied to Roche by Inovio shall be provided at
Inovio’s FBMC.

 

  5.4.3.2 Option 2: At any time, in its sole discretion and at no additional
upfront cost to Roche, Roche may opt to solely develop and supply the Delivery
Device. All cost incurred in development shall be borne by Roche. Inovio shall
support Roche in such development, including by providing promptly after such
election the transfer of technology set forth in Section 5.3.4, and by providing
ongoing FTE support to Roche at the FTE Rate. Roche shall keep Inovio reasonably
informed about the ongoing development of Delivery Devices.

 

5.4.4 For clarity, any Roche Inventions resulting from the development by Roche
of Delivery Devices under this Section 5.4.3, or under a related Device Supply
Agreement, shall be subject to the license granted by Roche to Inovio under
Section 3.3.

 

- 31 -

--------------------------------------------------------------------------------

5.5 GMP

The Parties and/or their Affiliates and/or Third Party manufacturers shall
execute, as requested by Roche, agreements, such as a quality agreement,
necessary or useful to ensure that all Products and their intermediates and
manufacturing facilities comply with GMP and all applicable laws and
regulations. Before any supplier or manufacturer implements any changes having
regulatory relevance, they shall require Roche’s approval before making such
changes. Roche shall have the opportunity to conduct full CMC due diligence and
environmental, health and safety (“EH&S”) audits of all suppliers and
manufacturers prior to entering into any agreement under this Section 5.5 and
any party to an agreement under this Section 5.5 shall implement the changes and
improvements stemming from such GMP and EH&S audits.

 

5.6 Commercialization

Roche, at its own expense, shall have sole responsibility and decision making
authority for the marketing, promotion, sale and distribution of Products in the
Territory.

 

5.7 Diligence

Roche shall use Commercially Reasonable Efforts to pursue further development
and commercialization of Products in the Territory. For each Research Program,
Roche shall be deemed to use Commercially Reasonable Efforts if it respectively
pursues development of at least one Oncology Product in at least one indication
and at least one HBV Product in one indication. Inovio shall use Commercially
Reasonable Efforts to conduct its activities under the Research Plans,
Development Plans, manufacturing and supply obligations, and technology transfer
obligations.

 

5.8 Updates to Inovio

For each Research Program, after the Research Term until Initiation of the first
Phase II Study for a Product from such Research Program, and upon request of
Inovio, Roche shall update Inovio regarding the development and
commercialization of Products in the Territory by Roche, its Affiliates and
Sublicensees. If Inovio requests an update, Roche shall provide a high level
summary, in writing and/or through a meeting (face to face/
tele-presence/videoconference or telephone). Inovio shall not request an update
more frequently than twice per Calendar Year.

 

6. Payment

 

6.1 Option Signing and Exclusivity Fee

Within thirty (30) days after the Effective Date and receipt of an invoice from
Inovio, in consideration for rights granted herein, Roche shall pay to Inovio a
one-time, non-refundable, non-creditable signing and exclusivity fee of Ten
Million US Dollars (US$10,000,000), attributable as follows:

 

a) ‘’’’’’’’’’ ‘’’’’’’’’’’’’’’’ ‘’’’’’’ ‘’’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ in consideration for the rights and licenses
in the 5150 Product;

 

b) ‘’’’’’’’’’’ ‘’’’’’’’’’’’’’’ ‘’’’’’’ ‘’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ in consideration for the rights and licenses
under the Oncology Research Program; and

 

c) ‘’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’ ‘’’’’’’ ‘’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ in consideration for the rights and
licenses in and to INO-1800 and the HBV Research Program

 

- 32 -

--------------------------------------------------------------------------------

6.2 Research and Development Support Payments

 

6.2.1 Oncology

 

  6.2.1.1 5150 Development Support Payments

Roche shall reimburse Inovio for the 5150 Development Support Payments in
accordance with Section 5.1.1 and Article 7.

 

  6.2.1.2 Oncology

Roche shall reimburse Inovio for those costs and expenses related to research
and development of DNA vaccines directed to the RC Targets under the Oncology
Research Plan and the Oncology Development Plan as agreed under the associated
budget’’ ‘’’’ ‘’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’ ‘’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’ ‘’’’ ‘’’’’’’ ‘’’’’’’’’’’’ ‘’’’’’’’’’’
‘’’’’’ ‘’’’’’’’ ‘’’’’’’’’’’ ‘’’’’ ‘’’’’’ ‘’’’ ‘’’’’’’’’’’’’’ ‘’’’’’
‘’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’ ‘’’’’’ ‘’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’
‘’’’’’’’’’’’ ‘’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’
‘’’’’’’’’’’’’’ ‘’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’

 

6.2.2 HBV

Roche shall reimburse Inovio for those costs and expenses related to the conduct
of HBV Research Plan and any associated Development Plan as agreed under the
associated budget in the Research Plan or Development Plan, as applicable.

 

6.3 Development Event Payments

 

6.3.1 Oncology Product Development Event Payments

‘’’’’’’’’’’’’’’’ ‘’’’’’’’’’’ ‘’’’’’’’’’ ‘’’’’’ ‘’’’ ‘’’’ ‘’’’’’’’’’’ ‘’’’
‘’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’
‘’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’
‘’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’
‘’’’’’’’’’’’’’’’’ to the achievements of development events with respect to all
Oncology Products. The development event payments under this Section 6.3.1 shall
be paid by Roche according to the following schedule of development events.

 

Development Event

   Payment for 5150
Product in Prostate
Cancer (in US$M)      Payment for RC
Product in Prostate
Cancer (in US$M)      Payment for
5150 Product
or RC Product
in up to two  (2)
Non-Prostate
Cancer
Indications (in US$M)        (Column 1)      (Column 2)      (Column 3)  

Initiation Phase I Study

     ‘’’’’’’         ‘’’’’’’         ‘’’’’’’   

Initiation Phase II Study

     ‘’’’’’         ‘’’’’’’’         ‘’’’’’’’   

Initiation Phase III Study

     ‘’’’’’         ‘’’’’’         ‘’’’’’   

BLA filing in US

     ‘’’’’’’         ‘’’’’’         ‘’’’’   

BLA filing in EU

     ‘’’’’’         ‘’’’’’’’         ‘’’’’’’   

BLA filing in ROW

     ‘’’’’’’’         ‘’’’’’’         ‘’’’’’’’   

BLA filing in Japan

     ‘’’’’’’         ‘’’’’’’         ‘’’’’’’      

 

 

    

 

 

    

 

 

 

Total

     ‘’’’’’’’ ‘’’’’  ‘’’’’’         ‘’’’’’’’ ‘’’’ ‘’’’’’’’’’’       
  ‘’’’’’’’ ‘’’’’ ‘’’’’’ ‘’’’’  ‘’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’   
     

 

 

    

 

 

    

 

 

 

 

- 33 -

--------------------------------------------------------------------------------

Each development event payment in Column 1 and Column 2 shall be paid only once
regardless of the number of Oncology Products achieving these development
events. Each development event payment in Column 3 shall be paid up to twice for
the first two indications other than prostate cancer whether achieved by a 5150
Product or an RC Product. As used herein, the indication “prostate cancer” shall
mean all indications within a given sub-block of the International Statistical
Classification of Diseases and Related Health Problems 10th Revision (ICD-10)
Version for 2010, e.g. sub-block C61 “Malignant neoplasm of prostate.” With
regard to other indications, each indication shall require treatment of a
separate organ. For example, breast cancer and colon cancer are separate
indications but metastatic versus adjuvant breast cancer would be considered a
single indication and not trigger a second set of Column 3 development event
payments. Upon reaching development events, Roche shall timely notify Inovio and
development event payments shall be paid by Roche to Inovio within ninety
(90) days from occurrence of the applicable event and receipt of an invoice from
Inovio. If development of a given Oncology Product is discontinued for any
reason, then the development event payments paid for such discontinued Oncology
Product shall be creditable against development event payments due for the next
Oncology Product in development.

 

6.3.2 HBV Product Development Event Payments

Roche shall pay up to a ‘’’’’’’’’’ ‘’’’’ ‘’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’
‘’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’ ‘’’’’’’’ ‘’’’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ in relation to the achievements of
development events with respect to all HBV Products in the first two
(2) indications developed for HBV Products (the “Initial Indications”). The
development event payments under this Section 6.3.2 shall be paid by Roche
according to the following schedule of development events in up to two
(2) indications.

 

Development Event

   Payment (in US$M)  

Initiation Phase I Study

     ‘’’’’’’   

Initiation Phase II Study

     ‘’’’’’’   

Initiation Phase III Study

     ‘’’’’’’   

BLA filing in US

     ‘’’’’’   

BLA filing in EU

     ‘’’’’’’   

BLA filing in ROW

     ‘’’’’’’   

BLA filing in Japan

     ‘’’’’’’      

 

 

 

Total per Initial Indication

    
 
 
  ‘’’’’’’ ‘’’’’ ‘’’’’’
‘’’’’’’’’’’ ‘’’ ‘’’’’’’’’
‘’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’   
  
  
     

 

 

 

For the two (2) Initial Indications developed for HBV Products, each development
event payment for a given Initial Indication shall be paid only once for the
first HBV Product that reaches such development event for such Initial
Indication. Upon reaching development events, Roche shall timely notify Inovio
and development event payments shall be paid by Roche to Inovio within ninety
(90) days from occurrence of the applicable event and receipt of an invoice from
Inovio. If development of a given HBV Product is discontinued for any reason in
a given

 

- 34 -

--------------------------------------------------------------------------------

Initial Indication, then the development event payments paid for such
discontinued HBV Product in such Initial Indication shall be creditable against
development event payments due for the next HBV Product in development for such
Initial Indication.

 

6.4 First Commercial Sale Event Payments

 

6.4.1 Oncology Product Commercial Sale Event Payments

Roche shall pay up to a total ‘’’’’ ‘’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’ ‘’’’’’’
‘’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ in relation to the
achievements of the first commercial sale events with respect to all Oncology
Products. The First Commercial Sale event payments under this Section 6.4.1
shall be paid by Roche according to the following schedule.

 

First Commercial Sale Event

   5150 Product (in US$M)      RC Product (in US$M)  

First Commercial Sale US

     ‘’’’’’         ‘’’’’’   

First Commercial Sale EU

     ‘’’’’’         ‘’’’’’   

First Commercial Sale ROW

     ‘’’’’’’         ‘’’’’’’   

First Commercial Sale Japan

     ‘’’’’’’’         ‘’’’’’’’      

 

 

    

 

 

 

Total All First Commercial Sale Events

     ‘’’’’’ ‘’’’’ ‘’’’’’         ‘’’’’’ ‘’’’ ‘’’’’      

 

 

    

 

 

 

 

6.4.2 HBV Product Commercial Sale Event Payments

Roche shall pay up to a total ‘’’’’ ‘’’’’’’’’’ ‘’’’’’’’’’’’’’’ ‘’’’’’’
‘’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ in relation to the
achievements of the first commercial sale events with respect to each HBV
Product. The First Commercial Sale event payments under this Section 6.4.2 shall
be paid by Roche according to the following schedule.

 

First Commercial Sale Event

   Payment
(US$ Millions)  

First Commercial Sale US

     ‘’’’’   

First Commercial Sale EU

     ‘’’’’’’   

First Commercial Sale ROW

     ‘’’’’’   

First Commercial Sale Japan

     ‘’’’’’’      

 

 

 

Total All First Commercial Sale Events per Product

     ‘’’’’’ ‘’’’ ‘’’’’      

 

 

 

 

6.5 Sales Based Payments

 

  i) Oncology Sales Based Payments

Roche shall pay up to a ‘‘‘‘‘‘‘‘‘ ‘‘‘‘‘ ‘‘‘‘‘‘‘‘‘‘ ‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘ ‘‘‘‘‘‘‘
‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘ ‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘‘ in relation to the
achievements of the following Net Sales levels with respect to the first
Oncology Product achieving such Net Sales levels in a single Calendar Year.

 

First achievement of Calendar Year Net Sales of an Oncology Product (US$
Billions)

   Payment
(US$ Millions)  

> 1.0

     ‘’’’’   

> 1.5

     ‘’’’’’’      

 

 

 

Total All Oncology Sales Based Payments

     ‘’’’’’ ‘’’’ ‘’’’’      

 

 

 

 

- 35 -

--------------------------------------------------------------------------------

6.5.1 HBV Product Commercial Sale Event Payments

Roche shall pay up to a total of ‘’’’’’’’’’’ ‘’’’’’’’’’’’’’ ‘’’’’’’
‘’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ in relation to the
achievements of the following Net Sales levels with respect to the first HBV
Product achieving such Net Sales levels in a single Calendar Year.

 

First achievement of Calendar Year Net Sales of an HBV Product (US$ Billions)

   Payment
(US$ Millions)  

> 1.0

     ‘’’’’’   

> 1.5

     ‘’’’’’      

 

 

 

Total All HBV Sales Based Payments

     ‘’’’’’ ‘’’’ ‘’’’’      

 

 

 

 

6.6 Roche Royalty Payments

 

6.6.1 Royalty Term

Royalties shall be payable by Roche on Net Sales of Products on a
Product-by-Product and country-by-country basis until the expiry of the Royalty
Term. Thereafter, the licenses shall be fully paid up and royalty-free.

 

6.6.2 Royalty Rates

 

  6.6.2.1 Royalty Rates for Oncology Products

The following royalty rates shall apply to the respective portions of aggregate
Calendar Year Net Sales of an Oncology Product in the Territory, on an
incremental basis, as follows:

 

a) For a 5150 Product:

 

Portion of Calendar Year Net Sales in million US$

   Percent (%) of Net Sales  

‘’’ ‘’’’ ‘’’’’’’’’

     ‘’’’’’’’   

‘’’ ‘’’’’’’’’’ ‘’’’ ‘’’’’’’’’’’’’’’

     ‘’’’’’’   

‘’’ ‘’’’’’’’’’’’ ‘’’ ‘’’’’’’’’’’’’

     ‘’’’’’   

‘’’ ‘’’’’’’’’’’’’’

     ‘’’’’’’   

 

b) For an RC Product:

 

Portion of Calendar Year Net Sales in million US$

   Percent (%) of Net Sales  

‘’’’ ‘’’ ‘’’’’’’’’’’’’’’

     ‘’’’’’’’   

‘’’’ ‘’’’’’’’’’’’ ‘’’ ‘’’’’’’’’’’’’’

     ‘’’’’’’   

‘’’ ‘’’’’’’’’’’’

     ‘’’’’’’’   

 

- 36 -

--------------------------------------------------------------------------------

For example’’ ‘’’ ‘’’’’’’’’ ‘’’’’’’’’’’’’ ‘’’’ ‘’’ ‘’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’
‘’’’’ ‘’’’’’’’ ‘’’’’’’’’’’’’’’’’’’ ‘’’’’’ ‘’’ ‘’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’ ‘’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’ ‘’’’’’’ ‘’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’
‘’’’’’ ‘’’’’’’’’’’ ‘’’’’’’’’ ‘’’’’’’’’’’’’’’ ‘’’’’ ‘’’’’’’’’’’ ‘’’’’’’’’’’’’’’’
‘’’’’’ ‘’’’’’’’’ ‘’’’’’’’’’ ‘’’’’’’’’’’’ ‘’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’
‘’’’’’’’’’’’’’’’’’’

‘’’’’’’’’’’’’ ‘’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’
‘’’’’’’’’’’’’ ‘’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’ ‘’’’’’’’’’’ ‘’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’ ‘’’’’’’’’’’’’ ‘’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’

 

  6.6.2.2 Royalty Rates for HBV Products

The following royalty rates shall apply to the respective portions of aggregate
Calendar Year Net Sales of an HCV Product in the Territory, on an incremental
basis, as follows:

 

Portion of Calendar Year Net Sales in million US$

   Percent (%) of Net Sales  

‘’’ ‘’’’ ‘’’’’’’’’’

     ‘’’’’’’’   

‘’’ ‘’’’’’’’’ ‘’’ ‘’’’’’’’’’’’

     ‘’’’’’’   

‘’’ ‘’’’’’’’’’’’’ ‘’’’ ‘’’’’’’’’’’’’

     ‘’’’’’’   

‘’’ ‘’’’’’’’’’’’’

     ‘’’’’’’   

For example’’ ‘’’ ‘’’’’’’’’ ‘’’’’’’’’’’’’ ‘’’’’ ‘’’’ ‘’’’’’’’’’’’’’’’’’’’ ‘’’’
‘’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’ ‘’’ ‘’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’
‘’’’’’’’’’’’’ ‘’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’ ‘’’’’’’’’’’’
‘’’’’’’ ‘’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’ ‘’’’’’’’’’’ ‘’’’’’’’’
‘’’’’’’’’’’’’’’ ‘’’’’ ‘’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’ ‘’’’’’’ ‘’’’’’’’’’
‘’’’’’’’’’’’ ‘’’’’’’’’’ ‘’’’’’ ‘’’’’’’’’’’’’’’’’’’’’ ‘’’’’ ‘’’’’’’’’’’’’’’’

‘’’’’’’’’’’’’ ‘’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’ ‘’’’’’’’’’’’
‘’’ ‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’ ‘’’’’’’’’’’ ‘’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’ ‘’’’’’’’’’’’ ‘’’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’
‘’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’
‘’’’’’’’’’’’’’’’’’’’’’’

For the purpose of calculating royalties of a Product, Calendar Year Net Sales
and the royalty rates, as applicable, shall be subject to the following
adjustments:

 

  6.6.2.3 Combination Product

If Roche, its Affiliates or Sublicensees intend to sell a Combination Product,
then the Parties shall meet approximately one (1) year prior to the anticipated
First Commercial Sale of such Combination Product to negotiate in good faith and
agree to an appropriate adjustment to Net Sales to reflect the relative
pharmaceutical activity of the Product and the other pharmaceutically active
agent(s) contained in the Combination Product. If, after such good faith
negotiations not to exceed ninety (90) days, the Parties cannot agree to an
appropriate adjustment to Net Sales, the dispute shall be initially referred to
the executive officers of the Parties in accordance with Section 16.2. Should
the Parties fail to agree within sixty (60) days of such referral, then the Net
Sales shall equal such portion of the Net Sales of the Combination Product that
is equivalent to the relative commercial value contributed by the components of
the Combination Product, as determined by an Expert jointly appointed by the
Parties within a further thirty (30) days. In the absence of an agreement on the
appointment of the Expert, each Party will select an Expert and the two Experts
shall select a third Expert, and the three Experts will determine the relative
commercial value contributed by the components of the Combination Product. The
decision of the Expert(s) shall be final and binding on the Parties and the fees
of the Expert(s) shall be shared equally between the Parties.

 

  6.6.2.4 Third Party Product

Upon the first entry in a given country of a Third Party product, the royalties
in such country for such Product shall be reduced as follows:

 

a)

If in any two (2) consecutive Calendar Quarters at any time after entry of a
Third Party Product there has been a decline of the sales of the applicable
Product in such country

 

- 37 -

--------------------------------------------------------------------------------

  greater than ‘’’’’’’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’ of
the level of the average Calendar Quarter sales of such Product achieved in the
Calendar Year immediately prior to such entry (divided by four per Calendar
Quarter), then (i) if there is a Valid Claim that Covers such Product, the
royalty payments due to Inovio for such Product in such country shall (unless
the Royalty Term had expired prior to such time for such Product in such
country) be reduced by ‘’’’’’’’ ‘’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’ and (ii) if
there is no Valid Claim that Covers such Product (or at such time as there is no
Valid Claim that Covers such Product), then the Royalty Term for such Product in
such country shall end (unless the Royalty Term had expired prior to such time
for a given Product in a given country), royalties shall no more be due by Roche
in such country for such Product, and the license in that country for such
Product shall be fully paid-up and irrevocable.

 

b) If in any two (2) consecutive Calendar Quarters at any time after entry of a
Third Party Product there has been a decline of the sales of the applicable
Product in such country greater than ‘’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’
of the level of the average Calendar Quarter sales of such Product achieved in
the Calendar Year immediately prior to such entry for each such Calendar
Quarter, then the royalty payments due to Inovio for such Product in such
country shall be ‘’’’’’’’’’’’ (unless the Royalty Term had expired prior to such
time for such Product in such country) and ‘’’’’’ ‘’’’’’’’’’’’’’’’’’’’’ shall be
due by Roche in such country for such Product.

 

  6.6.2.5 No Valid Claim

Notwithstanding Section 6.6.2.4, if no Valid Claim in the Inovio Background
Patent Rights or Joint Patent Rights Covers using, selling, offering for sale or
importing a Product in a country, then the royalties on such Product in such
country shall be reduced by fifty percent (50%).

 

  6.6.2.6 Third Party Payments

Inovio shall be responsible for any consideration owed or payable to any Third
Party in relation to Third Party intellectual property rights related to the
licenses and rights granted pursuant to this Agreement that, to the best of
Inovio’s knowledge, exists as of the Effective Date, including any amounts due
under the Existing Agreements (as currently written or as amended either prior
to or after the Effective Date) payable based on the development, manufacture or
sale of Products or Delivery Devices by either Party under this Agreement. The
foregoing obligation includes the obligation to pay any amounts imposed on
either Roche or Inovio resulting from any delay or failure by Inovio to pay any
amounts due in accordance with the foregoing sentence. Inovio shall be
responsible and liable to maintain the Existing Agreements. Otherwise, Roche
shall be responsible for and pay or have paid any consideration owed to any
Third Party in relation to Third Party intellectual property rights for
Products. Roche shall have the right to deduct fifty percent (50%) of such
consideration actually paid to a Third Party from payments otherwise due and
payable by Roche to Inovio under this Agreement (“Third Party Offset”). Any such
deduction shall be permitted on a Product-by-Product and country-by-country
basis; however, in no event shall the Third Party Offset reduce the amounts
payable to Inovio under Sections 6.6.2.1 or 6.6.2.2 by more than fifty percent
(50%). For clarity, the foregoing does not limit further reductions that may be
applicable under Section 6.6.2.4.

 

  6.6.2.7 Apportionment of Compulsory Sublicensee Consideration

At such time as Roche or any of its Affiliates or Sublicensees enters into a
sublicense with a Compulsory Sublicensee, the Parties will discuss and mutually
agree upon an adjustment of the royalty due to Inovio under Section 6.6 of this
Agreement with respect to sales of Products by such Compulsory Sublicensee.

 

- 38 -

--------------------------------------------------------------------------------

6.7 Disclosure of Payments

Inovio acknowledges that Roche may be obligated to disclose this financial
arrangement, including all fees, payments and transfers of value, as may be
advisable or required under applicable law, including the US Sunshine Act,
provided that, to the extent possible, Roche gives Inovio reasonable timely
notice in order for Inovio to meet its disclosure requirements, if any.

 

7. Accounting and reporting

 

7.1 Invoices

Inovio shall send invoices to Roche at the end of each Calendar Quarter for any
payments due by Roche to Inovio hereunder. Each invoice be accompanied by a DRSP
Report and shall identify the trigger for the payment obligation. Unless
otherwise requested by Roche in writing, Inovio shall send invoices to Roche as
provide for under Section 16.14, with a copy to the appropriate Roche Alliance
Director.

 

7.2 DSRP Reports for Development Support Payments

Within thirty (30) calendar days after the end of each Calendar Quarter, Inovio
shall provide to Roche a report for such Calendar Quarter detailing the expenses
incurred by Inovio pursuant to its performance of its obligations under Sections
2.1 and 5.1, including (a) expenses incurred pursuant to the Development Plan
for the Inovio 5150 Trial, provided that the cumulative total of such expenses
that Roche is obligated to pay shall not exceed one hundred ten percent
(110%) of the amount budgeted for the conduct of the Inovio 5150 Trial that is
current and agreed as of the Effective Date, (b) such FTEs committed under the
Oncology Research Plan and the HBV Research Plan during that Calendar Quarter
(provided that the cumulative total of such expenses that Roche is obligated to
pay shall not exceed one hundred ten percent (110%) of the amount budgeted by
the JSC, the identity of the individuals included within those FTEs, the
percentage of an FTE that each individual represents, and a brief summary of the
work performed, and (c) detail around any other reimbursable costs or expenses
incurred in the conduct of a Research Plan (such report a “DSRP Report”). Upon
Roche’s request, Inovio will provide an annual budget of its anticipated
development and/or research support costs and such costs shall be subject to JSC
approval.

 

7.3 Timing of Payments

 

7.3.1 Payment under a DSRP Report

Payments detailed in a DSRP Report shall be paid by Roche within thirty
(30) days after receipt by Roche of (i) an Invoice and (ii) the DSRP Report from
Inovio.

 

7.3.2 Royalties

Roche shall calculate royalties on Net Sales quarterly as of
March 31, June 30, September 30 and December 31 (each being the last day of an
“Accounting Period”) and shall pay royalties on Net Sales within the ninety
(90) days after the end of each Accounting Period in which such Net Sales occur.

 

7.4 Late Payment

Any payment under this Agreement that is not paid on or before the date such
payment is due shall bear interest, to the extent permitted by applicable law,
at two (2) percentage points above the average one-month Euro Interbank Offered
Rate (EURIBOR), as reported by Reuters from time to time, calculated on the
number of days such payment is overdue.

 

- 39 -

--------------------------------------------------------------------------------

7.5 Method of Payment

Royalties on Net Sales and all other amounts payable by Roche hereunder shall be
paid by Roche in US$ (the “Payment Currency”) to account(s) designated by
Inovio.

 

7.6 Currency Conversion

When calculating the Sales and Net Sales of any royalty-bearing Product that
occur in currencies other than the Payment Currency, Roche shall convert the
amount of such sales into Swiss Francs and then into the Payment Currency using
Roche’s then-current internal foreign currency translation actually used on a
consistent basis in preparing its audited financial statements (currently YTD
average rate as reported by Thomson Reuters).

 

7.7 Royalty Reports

With each royalty payment Roche shall provide Inovio in writing for the relevant
Calendar Quarter on a Product-by-Product basis the following information:

 

a) Sales in Swiss Francs on a country-by-country basis;

 

b) Net Sales in Swiss Francs on a country-by-country basis;

 

c) Adjustments made pursuant to Sections 6.6.2.3 - 6.6.2.6 in Swiss Francs on a
country by country basis;

 

d) Net Sales in Swiss Francs after adjustments made pursuant to Sections 6.6.2.3
- .6.2.6, on a country by country basis;

 

e) Total Net Sales in the Territory after adjustments made pursuant to Sections
6.6.2.3 - 6.6.2.6, in Swiss Francs;

 

f) Exchange rates used for the conversion of Net Sales from Swiss Francs to the
Payment Currency made under Section 7.6;

 

g) Total Net Sales in the Territory after adjustments made pursuant to Sections
6.6.2.3 - 6.6.2.6 in the Payment Currency;

 

h) Royalty rate pursuant to Section 6.4; and

 

i) Total royalty payable to Inovio in the Payment Currency.

For illustrative purposes only, a royalty report template is attached as
Appendix 7.7.

 

8. Taxes

Inovio shall pay all sales, turnover, income, revenue, value added, and other
taxes levied on account of any payments accruing or made to Inovio under this
Agreement.

If provision is made in law or regulation of any country for withholding of
taxes of any type, levies or other charges with respect to any royalty or other
amounts payable under this Agreement to Inovio, then Roche shall promptly pay
such tax, levy or charge for and on behalf of Inovio to the proper governmental
authority, and shall promptly furnish Inovio with receipt of payment. Roche
shall be entitled to deduct any such tax, levy or charge actually paid from
royalty or other payment due Inovio or be promptly reimbursed by Inovio if no
further payments are due Inovio. Each Party agrees to reasonably assist the
other Party in claiming exemption from such deductions or withholdings under
double taxation or similar agreement or treaty from time to time in force and in
minimizing the amount required to be so withheld or deducted.

 

9. Auditing

 

9.1 Right to Audit

Inovio shall keep complete and accurate records for a period of at least three
(3) years for each reporting period during which payments are due for research
or development activities

 

- 40 -

--------------------------------------------------------------------------------

hereunder, showing the particulars necessary in sufficient detail to enable DRSP
Reports to be verified. Roche shall keep, and shall require its Affiliates and
Sublicensees to keep, full, true and accurate books of account containing all
particulars that may be necessary for the purpose of calculating all royalties
payable under this Agreement. Such books of accounts shall be kept at their
principal place of business. At the expense of the auditing Party, the auditing
Party has the right to engage an independent public accountant reasonably
acceptable to the selling Party to perform, on behalf of the auditing Party an
audit of such books and records of the audited Party and its Affiliates, its
licensees and Sublicensees, that are deemed necessary by the auditing Party’s
independent public accountant to report on Net Sales of Product for the period
or periods requested by the auditing Party and the correctness of any financial
report or payments made or invoiced under this Agreement.

Upon timely request and at least sixty (60) working days’ prior written notice
from the auditing Party, such audit shall be conducted in the countries
specifically requested by the auditing Party, during regular business hours in
such a manner as to not unnecessarily interfere with the selling Party’s normal
business activities, and shall be limited to results in the three (3) calendar
years prior to audit notification.

Such audit shall not be performed more frequently than once per Calendar Year
nor more frequently than once with respect to records covering any specific
period of time.

All information, data documents and abstracts herein referred to shall be used
only for the purpose of verifying the applicable invoice or statement or
payment, shall be treated as the selling Party’s Confidential Information
subject to the obligations of this Agreement and need neither be retained more
than one (1) year after completion of an audit hereof, if an audit has been
requested; nor more than three (3) years from the end of the calendar year to
which each shall pertain; nor more than one (1) year after the date of
termination of this Agreement.

 

9.2 Audit reports

The auditors shall only state factual findings in the audit reports and shall
not interpret the agreement. The auditors shall share all draft audit reports
with the selling Party before the draft report is shared with the auditing Party
and before the final document is issued. The final audit report shall be shared
with the selling Party at the same time it is shared with the auditing Party.

 

9.3 Over-or Underpayment

If the audit reveals an overpayment, the auditing Party shall reimburse the
audited Party for the amount of the overpayment within thirty (30) days. If the
audit reveals an underpayment, the audited Party shall make up such underpayment
with the next royalty payment or, if no further royalty payments are owed to the
auditing Party, the audited Party shall reimburse the auditing Party for the
amount of the underpayment within thirty (30) days. The audited Party shall pay
for the audit costs if the underpayment of the audited Party exceeds five
percent (5%) of the aggregate amount of payments owed with regard to the
invoices or statements subject of the audit. Section 7.4 shall apply to this
Section 9.3.

 

9.4 Duration of Audit Rights

The failure of an auditing Party to request an audit within the period during
which corresponding records must be maintained under this Article 9 will be
deemed to be acceptance of the payments, invoices and reports.

 

- 41 -

--------------------------------------------------------------------------------

10. Intellectual Property

 

10.1 Disclosure of Inventions

Inovio shall promptly disclose to Roche in writing any Collaboration IP created,
discovered, conceived or reduced to practice pursuant to the activities
conducted under a Research Program or Development Plan. During the Term, Inovio
shall disclose to Roche all Patents within Inovio Patent Rights and Joint IP
Rights, including any such Patents which Inovio Controls after the Effective
Date.

 

10.2 Ownership of Inventions

Roche shall own all Roche Inventions. Inovio shall own all Inovio Inventions.

All Collaboration IP, and the Inventions contained therein, shall be jointly
owned by the Parties. Subject to the licenses granted by one Party to the other
under this Agreement, each Party retains a full, undivided, one-half interest
ownership right (including as provided under 35 U.S.C. §262) in and to such
Collaboration Inventions, for any field, and including the right to license and
sublicense, and to freely exploit, transfer or encumber its ownership interest,
without the consent of, or payment or accounting to, the other Party. Each Party
hereby waives any right it may have under the laws of any jurisdiction to
require such payment, accounting, or consent with respect to Collaboration
Inventions. Each Party hereby agrees to take such action as necessary to
evidence, and shall require all of its employees, contractors, sublicensees and
agents, and any Affiliates and permitted Third Parties working on its behalf
under this Agreement (and their respective employees, contractors and agents) to
take such action as necessary to evidence the foregoing joint ownership rights
in and to any and all Collaboration IP.

The determination of inventorship for Inventions shall be in accordance with US
inventorship laws as if such Inventions were made in the US.

 

10.3 German Statute on Employee’s Inventions

In accordance with the German Statute on Employees’ Inventions, each Party
agrees to claim the unlimited use of any Invention conceived, reduced to
practice, developed, made or created in the performance of, or as a result of,
any Research Program by its German employees or any other German person acting
on its behalf. The Party which is the ultimate assignee of the German employee’s
or other person’s Invention under this Agreement shall pay any royalty or other
compensation payable to the employee or other person, and the Parties agree that
the Party which is the ultimate assignee must agree to the royalty or other
compensation negotiated with the employee or other person.

 

10.4 Prosecution of Patent Rights Covering Inventions

Roche shall, at its own expense and discretion, Handle all Roche Patent Rights
and Joint Patent Rights.

To the extent that Roche has an exclusive license under a Development &
Commercialization License to any Inovio Patent Rights, Roche shall have the
right to Handle all such Inovio Patent Rights unless Inovio is prohibited from
granting Roche the right to Handle those Inovio Patent Rights Controlled
pursuant to the Existing Agreements, in which case Inovio shall use diligent
efforts to amend the Existing Agreements to secure Roche’s right to Handle the
Inovio Patent Rights Controlled pursuant to the Existing Agreements, which shall
be subject to Third Party agreement. Inovio shall, at its own expense and
discretion, Handle Inovio Patent Rights that are not subject to the
exclusively-licensed portion of the Development & Commercialization License. For
clarity, if Roche is Handling Patent Rights, then Roche will pay for such
Handling; otherwise, Inovio shall pay for the Handling of Patent Rights.

 

- 42 -

--------------------------------------------------------------------------------

Roche shall furnish Inovio with copies of all documents relevant to any such
Handling of Inovio Patent Rights and Joint Patent Rights. At Roche’s reasonable
request, Inovio shall cooperate, in all reasonable ways with Roche’s Handling of
Inovio Patent Rights and Joint Patent Rights.

 

10.5 CREATE Act

It is the intention of the Parties that this Agreement is a “joint research
agreement” as that phrase is defined in 35 USC §103(c)(3).

 

10.6 Infringement

Each Party shall promptly provide written notice to the other Party during the
term of this Agreement of any (i) known infringement or suspected infringement
by a Third Party of any Inovio Patent Rights, Roche Patent Rights or Joint
Patent Rights, or (ii) known or suspected unauthorized use or misappropriation
by a Third Party of any Inovio Know-How, Roche Know-How or Joint Know-How, and
shall provide the other Party with all evidence in its possession supporting
such infringement or unauthorized use or misappropriation.

Within sixty (60) days after Roche provides or receives such written notice
(“Decision Period”), Roche, in its sole discretion, shall decide whether or not
to initiate such suit or action in the Territory and shall notify Inovio in
writing of its decision in writing (“Suit Notice”).

If Roche decides to bring a suit or take action, once Roche provides Suit
Notice, Roche may immediately commence such suit or take such action. In the
event that Roche (i) does not in writing advise Inovio within the Decision
Period that Roche will commence suit or take action, or (ii) fails to commence
suit or take action within a reasonable time after providing Suit Notice, then,
solely to the extent such suit or action relates to an Inovio Patent Right or a
Joint Patent Right, Inovio shall thereafter have the right to commence suit or
take action in the Territory and shall provide written notice to Roche of any
such suit commenced or action taken by Inovio.

Upon written request, the Party bringing suit or taking action (“Initiating
Party”) shall keep the other Party informed of the status of any such suit or
action and shall provide the other Party with copies, to the extent the
Initiating Party is lawfully permitted to do so, of all substantive documents or
communications filed in such suit or action. The Initiating Party shall have the
sole and exclusive right to select counsel for any such suit or action.

The Initiating Party shall, except as provided below, pay all expenses of the
suit or action, including the Initiating Party’s attorneys’ fees and court
costs. Any damages, settlement fees or other consideration received as a result
of such suit or action shall be allocated as follows:

 

a) First, to reimburse the Initiating Party for its costs and, if any remains,
to the other Party for any advisory counsel fees and costs; and

 

b) Second, the balance, if any, shall be allocated seventy five percent (75%) to
the Initiating Party, and twenty five percent (25%) to the other Party.

If the Initiating Party believes it is reasonably necessary or desirable to
obtain an effective remedy, upon written request the other Party agrees to be
joined as a party to the suit or action but shall be under no obligation to
participate except to the extent that such participation is required as the
result of its being a named party to the suit or action. At the Initiating
Party’s written request, the other Party shall offer reasonable assistance to
the Initiating Party in connection therewith at no charge to the Initiating
Party. The other Party shall have the right to participate and be represented in
any such suit or action by its own counsel at its own expense.

 

- 43 -

--------------------------------------------------------------------------------

The Initiating Party may settle, consent judgment or otherwise voluntarily
dispose of the suit or action (“Settlement”) without the written consent of the
other Party but only if such Settlement can be achieved without adversely
affecting the other Party (including any of its Patent Rights). If a Settlement
could adversely affect the other Party, then the written consent of the other
Party would be required, which consent shall not be unreasonably withheld.

For any patent that is not an Inovio Patent Right, Roche, in its sole
discretion, shall decide whether or not to initiate such suit or action in the
Territory. Roche shall have full discretion as to how it wishes to handle such
suit and may reach Settlement and retain all damages, settlement fees or other
consideration under any terms and conditions it desires and retain whatever.
Only if a Settlement could adversely affect Inovio shall the written consent of
Inovio be required, which consent shall not be unreasonably withheld.

 

10.7 Defense

If an action for infringement is commenced against either Party, its licensees
or its sublicensees related to Inovio’s conduct of the Research Program or its
activities within the scope of a Research Plan or Development Plan or the
discovery, development, manufacture, use or sale of a Product, then Roche shall
defend such action at its own expense, and Inovio shall assist and cooperate
with Roche to the extent necessary in the defense of such suit. Roche shall have
the right to settle the suit or consent to an adverse judgment thereto, in its
sole discretion, so long as such settlement or adverse judgment does not
adversely affect the rights of Inovio and its Affiliates (including any patent
rights Controlled by any of them). Roche shall assume full responsibility for
the payment of any award for damages, or any amount due pursuant to any
settlement entered into by it with such Third Party.

If the manufacture, use, importation, offer for sale or sale of any Product
pursuant to this Agreement results in any claim, suit or proceeding alleging
patent infringement or trade secret misappropriation against Inovio or a member
of the Roche Group, then such Party shall promptly notify the other Party
hereto. The Parties shall cooperate with each other in connection with any such
claim, suit or proceeding and shall keep each other reasonably informed of all
material developments in connection with any such claim, suit or proceeding.

If a Third Party asserts that Patent Rights owned by or licensed to it are
infringed by the development, manufacture, use, importation, offer for sale or
sale of Products by a member of the Roche Group, or that its trade secrets were
misappropriated in connection with such activity, then Roche shall have the
exclusive right and responsibility to resolve any such claim, whether by
obtaining a license from such Third Party, by defending against such Third
Party’s claims or otherwise, and shall be solely responsible for the defense of
any such action, any and all costs incurred in connection with such action
(including, without limitation, attorneys’ and expert fees) and all liabilities
incurred in connection therewith. Notwithstanding the above, Roche shall not
enter into any settlement of any such claim without the prior written consent of
Inovio if such settlement would require Inovio to be subject to an injunction or
to make any monetary payment to Roche or any Third Party, or admit any wrongful
conduct by Inovio or its Affiliates, or would limit or restrict the claims of or
admit any invalidity and/or unenforceability of any of the Patent Rights
Controlled by Inovio.

 

10.8 Common Interest Disclosures

With regard to any information or opinions disclosed pursuant to this Agreement
by one Party to each other regarding intellectual property and/or technology
owned by Third Parties, the Parties agree that they have a common legal interest
in determining whether, and to what extent, Third Party intellectual property
rights may affect the conduct of the activities under this Agreement and/or DNA
Plasmids and/or Adjuvants and/or Products and/or Delivery Devices, and have a

 

- 44 -

--------------------------------------------------------------------------------

further common legal interest in defending against any actual or prospective
Third Party claims based on allegations of misuse or infringement of
intellectual property rights relating to the conduct of the activities under
this Agreement and/or DNA Plasmids and/or Adjuvants and/or Products and/or
Delivery Devices. Accordingly, the Parties agree that all such information and
materials obtained by Inovio and Roche from each other will be used solely for
purposes of the Parties’ common legal interests with respect to the conduct of
the Agreement. All information and materials will be treated as protected by the
attorney-client privilege, the work product privilege, and any other privilege
or immunity that may otherwise be applicable. By sharing any such information
and materials, neither Party intends to waive or limit any privilege or immunity
that may apply to the shared information and materials. Neither Party shall have
the authority to waive any privilege or immunity on behalf of the other Party
without such other Party’s prior written consent, nor shall the waiver of
privilege or immunity resulting from the conduct of one Party be deemed to apply
against any other Party.

 

10.9 Hatch-Waxman

Notwithstanding anything herein to the contrary, should a Party receive a
certification for a Product pursuant to the Drug Price Competition and Patent
Term Restoration Act of 1984 (Public Law 98-417, known as the Hatch-Waxman Act),
as amended, or its equivalent in a country other than the US, then such Party
shall immediately provide the other Party with a copy of such certification.
Roche shall have thirty (30) days from date on which it receives or provides a
copy of such certification to provide written notice to Inovio (“H-W Suit
Notice”) whether Roche will bring suit, at its expense, within a forty-five
(45) day period from the date of such certification. Should such thirty (30) day
period expire without Roche bringing suit or providing such H-W Suit Notice,
then Inovio shall be free to immediately bring suit in its name.

 

10.10 Biosimilar or interchangeable biological products

Notwithstanding anything herein to the contrary, within four (4) years after the
approval of a Product that has been licensed in the US as a biological product
under 42 USC 262(a), and as may be needed from time to time thereafter, the
Parties shall consult as to potential strategies with respect to unexpired US
Patent Rights that Cover the Product. Specifically, in anticipation of a receipt
by the Product’s reference product sponsor (“Reference Product Sponsor”) of a
biosimilar or interchangeable product application pursuant to the Biologics
Price Competition and Innovation Act of 2009 (Public Law 111-148), the Parties
will discuss the Reference Product Sponsor’s likely course of action with regard
to each such US Patent Right in the procedural steps set forth under 42 USC
§262(l), including a general plan for timely communication between the Parties
in light of the statutory response deadlines.

 

10.11 Patent Term Extensions

The Parties shall use Commercially Reasonable Efforts to obtain all available
patent term extensions, adjustments or restorations, or supplementary protection
certificates (“SPCs”, and together with patent term extensions, adjustments and
restorations, “Patent Term Extensions”). Inovio shall execute, or shall cause
its licensor to execute, such authorizations and other documents and take such
other actions as may be reasonably requested by Roche to obtain such Patent Term
Extensions, including designating Roche as its agent for such purpose as
provided in 35 U.S.C. Section 156. All filings for such Patent Term Extensions
shall be made by Roche; provided, that in the event that Roche elects not to
file for a Patent Term Extension, Roche shall (a) promptly inform Inovio of its
intention not to file and (b) grant Inovio the right to file for such Patent
Term Extension. Each Party shall execute such authorizations and other documents
and take such other actions as may be reasonably requested by the other Party to
obtain such extensions. The Parties shall cooperate with each other in gaining
patent term restorations, extensions and/or SPCs wherever applicable to such
Inovio Patent Rights.

 

- 45 -

--------------------------------------------------------------------------------

11. Representations, Warranties and Covenants

 

11.1 Inovio Representations, Warranties and Covenants

 

11.1.1 Existing Agreements

Inovio is not currently in material breach of any of its obligations under the
Existing Agreements and the Existing Agreements are in full force and effect,
and Inovio covenants that it shall use diligent efforts not to materially breach
any of its obligations under the Existing Agreements after the Effective Date.

 

11.1.2 Safety Data

Inovio has disclosed to Roche and will immediately continue to disclose to Roche
(i) the results of all preclinical testing of DNA Plasmids, Adjuvants, Products
and Delivery Devices in its possession or control and (ii) all information in
its possession or control concerning side effects, injury, toxicity or
sensitivity reaction and incidents or severity thereof with respect to DNA
Plasmids, Adjuvants, Products and Delivery Devices.

 

11.1.3 Third Party Rights

Inovio has no knowledge of the existence of any patent or patent application
owned by or licensed to any Third Party or contractual obligations to Third
Parties that could prevent Roche from making, having made, using, offering for
sale, selling or importing DNA Plasmids, Adjuvants, Products and Delivery
Devices generally in the Territory. Inovio is not aware of any infringement or
misappropriation of the Inovio IP Rights existing as of the Effective Date by
any Third Party.

 

11.1.4 Control of Patent Rights

Inovio is the exclusive owner of all right, title and interest in, or is the
exclusive licensee of the Inovio IP Rights, free and clear of any liens or
encumbrances. Appendix 1.54 is a complete and accurate list of all Patent Rights
owned by or Controlled by Inovio as of the Effective Date that are useful or
necessary to research, develop manufacture and commercialize Products, including
the DNA Plasmids, Adjuvants and Delivery Devices associated therewith.

 

11.1.5 Inventors

All of Inovio’s employees, officers and consultants have executed agreements
requiring assignment to Inovio of all Inventions made by such individuals during
the course of and as a result of their association with Inovio.

 

11.1.6 Grants

Inovio warrants that it has the full right, power and authority, and has
obtained all approvals, permits or consents necessary, to enter into this
Agreement and to perform all of its obligations and to grant the licenses
provided hereunder.

 

11.1.7 Authorization

The execution, delivery and performance of this Agreement by Inovio and all
instruments and documents to be delivered by Inovio hereunder: (i) are within
the corporate power of Inovio; (ii) have been duly authorized by all necessary
or proper corporate action; (iii) are not in contravention of any provision of
the certificate of formation or limited liability company agreement of Inovio;
(iv) to the knowledge of Inovio, will not violate any law or regulation or any
order or decree of any court of governmental instrumentality; (v) will not
violate the terms of any indenture, mortgage, deed of trust, lease, agreement,
or other instrument to which Inovio is a

 

- 46 -

--------------------------------------------------------------------------------

party or by which Inovio or any of its property is bound, which violation would
have an adverse effect on the financial condition of Inovio or on the ability of
Inovio to perform its obligations hereunder; and (vi) do not require any filing
or registration with, or the consent or approval of, any governmental body,
agency, authority or any other person, which has not been made or obtained
previously (other than Regulatory Approvals required for the sale of Products
and filings with Regulatory Authorities required in connection with Products).

 

11.1.8 Ownership and Validity of Know-How

Inovio’s Know-How is legitimately in the possession of Inovio and has not been
misappropriated from any Third Party. Inovio Controls the Patents and Know-How
necessary to (i) use the Adjuvants’’ ‘’’’’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’ in
the manner contemplated by this Agreement, and (ii) grant to Roche the right to
use such Adjuvants. Inovio has taken reasonable measures to protect the
confidentiality of its Know-How. To the knowledge of Inovio, none of the Patents
within the Inovio Patent Rights existing as of the Effective Date are invalid or
unenforceable.

 

11.1.9 No Claims

There are no claims or investigations pending or threatened against Inovio or
any of its Affiliates, at law or in equity, or before or by any governmental
authority relating to the matters contemplated under this Agreement or that
would materially adversely affect Inovio’s ability to perform its obligations
hereunder. No claims of infringement, misappropriation or other conflict with
any intellectual property rights or other rights owned or controlled by any
Third Party have been made or threatened with respect to the Inovio IP Rights
existing as of the Effective Date.

 

11.1.10 No Conflict

Neither Inovio nor any of its Affiliates is or will be under any obligation to
any person, contractual or otherwise, that is conflicting with the terms of this
Agreement or that would impede the fulfillment of Inovio’s obligations
hereunder.

 

11.1.11 No Other Representations

EXCEPT AS OTHERWISE PROVIDED IN THIS AGREEMENT, THE FOREGOING REPRESENTATIONS
AND WARRANTIES ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS
OR IMPLIED, INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE OF PRODUCTS.

 

11.2 Roche Representations, Warranties and Covenants

 

11.2.1 Inventors

All of Roche’s employees, officers and consultants shall be required to assign
to Roche of all Inventions made by such individuals during the course of and as
a result of their activities pursuant to this Agreement.

 

11.2.2 Grants

Roche warrants that it has the full right, power and authority, and has obtained
all approvals, permits or consents necessary, to enter into this Agreement and
to perform all of its obligations hereunder.

 

11.2.3 Authorization

The execution, delivery and performance of this Agreement by Roche and all
instruments and documents to be delivered by Roche hereunder: (i) are within the
corporate power of Roche; (ii) have been duly authorized by all necessary or
proper corporate action; (iii) are not in

 

- 47 -

--------------------------------------------------------------------------------

contravention of any provision of the certificate of formation or limited
liability company agreement of Roche; (iv) to the knowledge of Roche, will not
violate any law or regulation or any order or decree of any court of
governmental instrumentality; (v) will not violate the terms of any indenture,
mortgage, deed of trust, lease, agreement, or other instrument to which Roche is
a party or by which Roche or any of its property is bound, which violation would
have an adverse effect on the financial condition of Roche or on the ability of
Roche to perform its obligations hereunder; and (vi) do not require any filing
or registration with, or the consent or approval of, any governmental body,
agency, authority or any other person, which has not been made or obtained
previously (other than Regulatory Approvals required for the sale of Products
and filings with Regulatory Authorities required in connection with Products).

 

11.2.4 No Claims

There are no claims or investigations pending or threatened against Roche or any
of its Affiliates, at law or in equity, or before or by any governmental
authority relating to the matters contemplated under this Agreement or that
would materially adversely affect Roche’s ability to perform its obligations
hereunder.

 

11.2.5 No Conflict

Neither Roche nor any of its Affiliates is or will be under any obligation to
any person, contractual or otherwise, that is conflicting with the terms of this
Agreement or that would impede the fulfillment of Roche’s obligations hereunder.

 

11.2.6 No Other Representations

EXCEPT AS OTHERWISE PROVIDED IN THIS AGREEMENT, THE FOREGOING REPRESENTATIONS
AND WARRANTIES ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS
OR IMPLIED, INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE OF PRODUCTS.

 

12. Indemnification

 

12.1 Indemnification by Roche

Roche shall indemnify, hold harmless and defend Inovio and its directors,
officers, employees and agents from and against any and all losses, expenses,
cost of defense (including without limitation attorneys’ fees, witness fees,
damages, judgments, fines and amounts paid in settlement) and any amounts Inovio
becomes legally obligated to pay because of any claim or claims against it to
the extent that such claim or claims arise out of activities related to the
Products (e.g. product liability claims) conducted by or on behalf of Roche,
except to the extent such losses, expenses, costs and amounts are due to the
gross negligence or willful misconduct or failure to act of Inovio, its
Affiliates or Third Party manufacturers.

 

12.2 Indemnification by Inovio

Inovio shall indemnify, hold harmless and defend Roche and its directors,
officers, employees and agents from and against any and all losses, expenses,
cost of defense (including without limitation attorneys’ fees, witness fees,
damages, judgments, fines and amounts paid in settlement) and any amounts Roche
becomes legally obligated to pay because of any claim or claims against it to
the extent that such claim or claims arise out of activities related to (i) the
Products (e.g. product liability claims) conducted by or on behalf of Inovio,
and/or (ii) DNA Plasmids and/or Adjuvants conducted by or on behalf of Inovio or
Roche, except to the extent such losses, expenses, costs and amounts are due to
the gross negligence or willful misconduct or failure to act of Roche, its
Affiliates or Third Party manufacturers.

 

- 48 -

--------------------------------------------------------------------------------

12.3 Procedure

In the event of a claim by a Third Party against a Party entitled to
indemnification under this Agreement (“Indemnified Party”), the Indemnified
Party shall promptly notify the other Party (“Indemnifying Party”) in writing of
the claim and the Indemnifying Party shall undertake and solely manage and
control, at its sole expense, the defense of the claim and its settlement. The
Indemnified Party shall cooperate with the Indemnifying Party and may, at its
option and expense, be represented in any such action or proceeding by counsel
of its choice. The Indemnifying Party shall not be liable for any litigation
costs or expenses incurred by the Indemnified Party without the Indemnifying
Party’s written consent. The Indemnifying Party shall not settle any such claim
unless such settlement fully and unconditionally releases the Indemnified Party
from all liability relating thereto, unless the Indemnified Party otherwise
agrees in writing.

 

13. Liability

Neither Party shall be liable to the other Party as a result of failure or delay
to develop and/or commercialize the Product, including but not limited to, a) a
delay in timelines, or b) delay or failure to recruit patients, or c) a change
in its respective study protocols, or d) failure of the other Party to obtain
regulatory approval for Products.

Except for breach of Section 14.1, NO PARTY SHALL BE ENTITLED TO RECOVER FROM
ANOTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES IN
CONNECTION WITH THIS AGREEMENT OR ANY LICENSE GRANTED HEREUNDER.

 

14. Obligation Not to Disclose Confidential Information

 

14.1 Non-Use and Non-Disclosure

During the Term of this Agreement and for five (5) years thereafter, a Receiving
Party shall (i) treat Confidential Information provided by Disclosing Party as
it would treat its own information of a similar nature, (ii) take all reasonable
precautions not to disclose such Confidential Information to Third Parties,
without the Disclosing Party’s prior written consent, and (iii) not use such
Confidential Information other than for fulfilling its obligations under this
Agreement.

 

14.2 Permitted Disclosure

Notwithstanding the obligation of non-use and non-disclosure set forth in
Section 14.1, the Parties recognize the need for certain exceptions to this
obligation, specifically set forth below, with respect to press releases, patent
rights, publications, and certain commercial considerations.

 

14.3 Press Releases

The Parties may issue a press release announcing the existence and selected key
terms of this Agreement, in a form substantially similar to the template
attached as Appendix 14.3.

Roche shall issue press releases in accordance with its internal policy that
typically does not issue a second press release until proof of concept has been
achieved for a Product. Roche shall provide Inovio with a copy of any draft
press release related to the activities contemplated by this Agreement at least
two (2) weeks prior to its intended publication for Inovio’s review. Inovio may
provide Roche with suggested modification to the draft press release. Roche
shall consider Inovio’s suggestions in issuing its press release.

 

- 49 -

--------------------------------------------------------------------------------

Inovio shall only issue press releases related to the activities contemplated by
this Agreement that have either (i) been approved by Roche or (ii) are required
to be issued by Inovio as a matter of law. In all circumstances, Inovio shall
provide Roche with a draft press release at least two (2) weeks prior to its
intended publication for Roche’s review. During such period, Roche shall
(i) approve the draft press release and permit Inovio to issue the press
release, (ii) contact Inovio to discuss modification to the draft press release,
or (iii) contact Inovio and disapprove the press release. If Roche asks for
modification, then Inovio shall either make such modification or work with Roche
to arrive at a press release that Roche approves. If Inovio issues a press
release without Roche’s approval, then Inovio’s decision must be based on a
legal opinion (either written or oral) that the release was required to be
issued by Inovio as a matter of law.

 

14.4 Publications

During the Term of this Agreement, the following restrictions shall apply with
respect to disclosure by any Party of Confidential Information relating to DNA
Plasmids, Adjuvants (to the extent specific to a Product), Products and Delivery
Devices Adjuvants (to the extent specific to a Product) in any publication or
presentation:

a) Both Parties acknowledge that it is their policy for the studies and results
thereof to be registered and published in accordance with their internal
guidelines. Roche, in accordance with its internal policies and procedures,
shall have the right to publish all studies, clinical trials and results thereof
on the clinical trial registries that are maintained by or on behalf of Roche.
Unless authorized by Roche in writing, Inovio shall not publish any studies,
clinical trials or results thereof on its clinical trial registry, provided
however, that Roche’s clinical trial registry can be accessed via a link from
Inovio’s clinical trial registry.

b) A Party (“Publishing Party”) shall provide the other Party with a copy of any
proposed publication or presentation at least thirty (30) days (or at least
twenty (20) days in the case of oral presentations) prior to submission for
publication so as to provide such other Party with an opportunity to recommend
any changes it reasonably believes are necessary to continue to maintain the
Confidential Information disclosed by the other Party to the Publishing Party in
accordance with the requirements of this Agreement. The incorporation of such
recommended changes shall not be unreasonably refused; and If such other Party
notifies (“Publishing Notice”) the Publishing Party in writing, within thirty
(30) days after receipt of the copy of the proposed publication or presentation
(or at least twenty (20) days in the case of oral presentations), that such
publication or presentation in its reasonable judgment (i) contains an
invention, solely or jointly conceived and/or reduced to practice by the other
Party, for which the other Party reasonably desires to obtain patent protection
or (ii) could be expected to have a material adverse effect on the commercial
value of any Confidential Information disclosed by the other Party to the
Publishing Party, the Publishing Party shall prevent such publication or delay
such publication for a mutually agreeable period of time. In the case of
inventions, a delay shall be for a period reasonably sufficient to permit the
timely preparation and filing of a patent application(s) on such invention, and
in no event less than ninety (90) days from the date of the Publishing Notice.

 

14.5 Commercial Considerations

Nothing in this Agreement shall prevent Roche or its Affiliates from disclosing
Confidential Information of Inovio to (i) governmental agencies to the extent
required or desirable to secure government approval for the development,
manufacture or sale of Product in the Territory, (ii) Third Parties acting on
behalf of Roche, to the extent reasonably necessary for the development,
manufacture or sale of Product in the Territory, or (iii) Third Parties to the
extent reasonably

 

- 50 -

--------------------------------------------------------------------------------

necessary to market the Product in the Territory. The Receiving Party may
disclose Confidential Information of the Disclosing Party to the extent that
such Confidential Information is required to be disclosed by the Receiving Party
to comply with applicable law, to defend or prosecute litigation or to comply
with governmental regulations, provided that the Receiving Party provides prior
written notice of such disclosure to the Disclosing Party and, to the extent
practicable, takes reasonable and lawful actions to minimize the degree of such
disclosure.

 

15. Term and Termination

 

15.1 Commencement and Term

This Agreement shall commence upon the Effective Date and continue for the
Agreement Term.

 

15.2 Termination

 

15.2.1 Termination for Breach

A Party (“Non-Breaching Party”) shall have the right to terminate this Agreement
in its entirety or on a country-by-country, Research Program-by-Research
Program, or Product-by-Product basis in the event the other Party (“Breaching
Party”) is in breach of any of its material obligations under this Agreement
related thereto. The non-Breaching Party shall provide written notice to the
Breaching Party, which notice shall identify the breach and the countries,
Research Program and/or Product in which the Non-Breaching Party intends to have
this Agreement terminate. The Breaching Party shall have a period of ninety
(90) days after such written notice is provided (“Peremptory Notice Period”) to
cure such breach. If the Breaching Party has a dispute as to whether such breach
occurred or has been cured, it will so notify the Non-Breaching Party, and the
expiration of the Preemptory Notice Period shall be tolled until such dispute is
resolved pursuant to Section 16.2. Upon a determination of breach or failure to
cure, the Breaching Party may have the remainder of the Preemptory Notice Period
to cure such breach. If such breach is not cured within the Peremptory Notice
Period, then absent withdrawal of the Non-Breaching Party’s request for
termination, this Agreement shall terminate in such countries effective as of
the expiration of the Preemptory Notice Period. Inovio’s failure to comply with
the CAPA Plan, Product Supply Agreements and/or Device Supply Agreements in all
material regards would be a material breach of this Agreement by Inovio. Inovio
shall have the Peremptory Notice Period to cure the first material breach of
compliance with the CAPA Plan. However, any subsequent failure to comply with
the CAPA Plans shall give Roche the right to immediately terminate this
Agreement upon written notice to Inovio.

 

15.2.2 Insolvency

A Party shall have the right to terminate this Agreement, if the other Party
incurs an Insolvency Event; provided, however, in the case of any involuntary
bankruptcy proceeding, such right to terminate shall only become effective if
the Party that incurs the Insolvency Event consents to the involuntary
bankruptcy or such proceeding is not dismissed within ninety (90) days after the
filing thereof.

 

15.2.3 Termination by Roche without Cause

Roche shall have the right to terminate this Agreement at any time on a Research
Program-by-Research Program, Product-by-Product and/or country-by-country basis
(i) upon ninety (90) days prior written notice before First Commercial Sale of
the Product to which the termination applies, and (ii) upon one hundred eighty
(180) days prior written notice after the First Commercial Sale of the Product
to which the termination applies. The effective date of termination under this
Section 15.2.3 shall be (i) ninety (90) days after, or (ii) one hundred eighty
(180) days after, as the case may be, Roche providing written notice to Inovio.

 

- 51 -

--------------------------------------------------------------------------------

15.3 Consequences of Termination

 

15.3.1 Termination by Inovio for Breach by Roche

Upon any termination by Inovio for breach by Roche, any ongoing Research Program
or development activities related to the subject matter of such breach shall
cease, and all rights and licenses granted by Inovio to Roche under this
Agreement shall also terminate in their entirety or on a country-by-country
basis, Research Program-by-Research Program, and/or Product-by-Product basis, as
applicable, on the effective date of termination. Roche will pay Inovio for any
unpaid Research and Development Support Payments actually incurred or committed
to be incurred under Section 6.2.

Any existing, permitted sublicense granted by Roche under this Agreement shall
continue in full force and effect, provided that the permitted Sublicensee did
not cause the breach that gave rise to a termination under Section 15.2.1, no
default exists under the sublicense with such permitted Sublicensee and such
permitted Sublicensee agrees to be bound by all the terms and conditions of this
Agreement that are applicable to such permitted Sublicensee including rendering
directly to Inovio all payments and other obligations due to Inovio related to
such sublicense (including all event payments and royalty payments).

If Inovio desires to continue development and/or commercialization of Product
(s), Inovio shall give a Continuation Election Notice to Roche within ninety
(90) days of Inovio’s notice of termination for breach by Roche. If Roche
receives such a timely Continuation Election Notice:

a) After the effective date of termination Roche shall, to the extent Roche has
the right to do so, assign and transfer to Inovio, at no expense to Inovio, the
Data Package to support the continued development and commercialization of
Products that were being developed and/or commercialized by Roche as of the
effective date of termination (each a “Termination Product”) . All documents
shall be transferred in the form and format in which such materials are
maintained by Roche. Original paper copies shall only be transferred, if legally
required. Roche shall not be required to prepare or finalize any new data,
reports or information solely for purposes of transfer to Inovio. In connection
with research studies or clinical trials, Roche may have collected human samples
and related clinical information for additional limited research and development
programs (“Samples”). Legal and contractual restrictions may apply to such
Samples, in particular as Samples may qualify as personal identifiable
information. Inovio acknowledges and accepts that notwithstanding anything
herein, Roche shall not be obliged to transfer any such Samples to Inovio.

b) At Inovio’s request, Roche shall assign all clinical trial agreements between
Roche and a Third Parties, to the extent such agreements (i) have not been
cancelled and are assignable without Roche paying any consideration or
commencing litigation in order to effect an assignment of any such agreement and
(ii) relate solely to the development of such Termination Products and/or the
management and continued performance of any clinical trials for such Termination
Product ongoing as of the effective date of such termination; provided that,
Inovio assumes all of Roche’s obligations (including payment obligations)
following the effective date of such assignment under such assigned agreement
and pays any fees payable to such Third Party in connection with such
assignment.

c) Inovio shall, upon transfer, have the right to disclose such filings,
approvals and data to (i) governmental agencies of the country to the extent
required or desirable to secure government approval for the development,
manufacturing or sale of Product(s) in the country, (ii) Third Parties acting on
behalf of Inovio, its Affiliates or licensees, to the extent reasonably
necessary for the development, manufacture, or sale of Product(s) in the
country, and (iii) Third Parties to the extent reasonably necessary to market
Product(s) in the country.

 

- 52 -

--------------------------------------------------------------------------------

d) Inovio shall have a ‘’’’’’’’’’’’’’’’’’’’’’’’’, non-exclusive license under
the Roche IP Rights, including Roche’s interest in the Joint Patent Rights and
Joint Know-How, solely to the extent necessary to allow Inovio, its Affiliates
or licensees to develop, manufacture, have manufactured, use, export and import
the applicable Termination Product(s) in the applicable country(ies), provided
that with respect to any Roche IP Rights obtained pursuant to an agreement with
a Third Party, Inovio assumes all of Roche’s obligations (including payment
obligations) under such agreement to the extent applicable to the Termination
Product(s). Inovio shall have a ‘’’’’’’’’’’’’’’’’’’’’’’’’’’, exclusive license
under the Roche IP Rights, including Roche’s interest in the Joint Patent Rights
and Joint Know-How, solely to the extent necessary to allow Inovio, its
Affiliates or licensees to offer for sale and sell the applicable Termination
Product(s) in the applicable country(ies), provided that with respect to any
Roche IP Rights obtained pursuant to an agreement with a Third Party, Inovio
assumes all of Roche’s obligations (including payment obligations) under such
agreement to the extent applicable to the Termination Product(s). For clarity,
the licenses under this Section 15.3.1(d) shall not include any licenses that
Roche has with a Third Party for which such grant would be prohibited or under
which a member of the Roche Group would incur financial obligations to such
Third Party.

 

15.3.2 Termination by Roche for Breach by Inovio or Inovio Insolvency

Upon any termination of this Agreement for breach by Inovio or Inovio’s
Insolvency pursuant to Section 15.2.1 or Section 15.2.2, as applicable, all
rights and licenses granted by Roche to Inovio under this Agreement shall
terminate in their entirety or on a Research Program-by Research Program,
country-by-country, and/or Product-by-Product basis, as applicable, on the
effective date of termination (except to the extent necessary to conduct any
additional activities as contemplated under this Article 15). All rights and
licenses granted to Roche under Article 3 shall become perpetual and
irrevocable, provided that Roche must exercise its Option Right for any RC
Targets within thirty (30) days after notice of an applicable termination.
Inovio’s obligations of exclusivity set forth in Section 2.1.5 shall continue
for Products and RC Targets (for those RC Targets subject to the Option Right,
such exclusivity shall only apply to those RC Targets for which Roche exercises
its Option Right). Inovio will promptly disclose to or provide Roche with any
Collaboration Invention not previously provided or disclosed to Roche.
Section 6.6 shall survive provided that all payments required to be paid shall
be reduced by fifty percent (50%) of what would otherwise have been owned. In
addition, if Inovio is responsible for conducting a Clinical Study for a
Terminated Product hereunder, then Section 15.3.4 shall apply.

 

15.3.3 Termination by Roche without Cause

Upon any termination by Roche without cause, any ongoing Research Program or
development activities related to the subject matter of such termination shall
cease, and all rights and licenses granted by Inovio to Roche under this
Agreement shall terminate in its entirety or on a country-by-country, Research
Program-by-Research Program, and/or Product-by Product basis, as applicable, on
the effective date of termination, provided that Roche shall have a fully
paid-up, non-exclusive license for Roche and its Affiliates to use the Inovio
Know-How for research purposes only. Roche will pay Inovio for any unpaid
Research and Development Support Payments actually incurred or committed to be
incurred under Section 6.2.

 

- 53 -

--------------------------------------------------------------------------------

If Inovio desires to continue development and/or commercialization of
Product(s), Inovio shall give a Continuation Election Notice to Roche within
ninety (90) days of receipt of Roche’s notice of termination without cause. If
Roche receives such a timely Continuation Election Notice:

a) After the effective date of termination Roche shall, to the extent Roche has
the right to do so, transfer to Inovio, at no expense to Inovio, the Data
Package to support the continued development and commercialization of
Termination Product(s). All documents shall be transferred in the form and
format in which such materials are maintained by Roche. Original paper copies
shall only be transferred, if legally required. Roche shall not be required to
prepare or finalize any new data, reports or information solely for purposes of
transfer to Inovio. In connection with research studies or clinical trials,
Roche may have collected Samples for additional limited research and development
programs. Legal and contractual restrictions may apply to such Samples, in
particular as Samples may qualify as personal identifiable information. Inovio
acknowledges and accepts that notwithstanding herein, Roche shall not be obliged
to transfer any such Samples to Inovio.

 

b) At Inovio’s request, Roche shall assign all clinical trial agreements between
Roche and a Third Parties, to the extent such agreements (i) have not been
cancelled and are assignable without Roche paying any consideration or
commencing litigation in order to effect an assignment of any such agreement and
(ii) relate solely to the development of such Termination Products and/or the
management and continued performance of any clinical trials for such Termination
Product ongoing as of the effective date of such termination; provided that,
Inovio assumes all of Roche’s obligations (including payment obligations)
following the effective date of such assignment under such assigned agreement
and pays any fees payable to such Third Party in connection with such
assignment.

 

c) Inovio shall, upon transfer, have the right to disclose such filings,
approvals and data to (i) governmental agencies of the country to the extent
required or desirable to secure government approval for the development,
manufacture or sale of Product(s) in the country; (ii) Third Parties acting on
behalf of Inovio, its Affiliates or licensees, to the extent reasonably
necessary solely for the development, manufacture, or sale of Product(s) in the
country, or (iii) Third Parties to the extent reasonably necessary to market
Product(s) in the country.

 

d) Inovio shall have a ‘’’’’’’’’’’’’’’’’’’’’’’’, non-exclusive license under the
Roche IP Rights, including Roche’s interest in the Joint Patent Rights and Joint
Know-How, solely to the extent necessary to allow Inovio, its Affiliates or
licensees to develop, manufacture, have manufactured, use, export and import the
applicable Termination Product(s) in the applicable country(ies), provided that
with respect to any Roche IP Rights obtained pursuant to an agreement with a
Third Party, Inovio assumes all of Roche’s obligations (including payment
obligations) under such agreement to the extent applicable to the Termination
Product(s). Inovio shall have a ‘’’’’’’’’’’’’’’’’’’’’’’’’’’, exclusive license
under the Roche IP Rights, including Roche’s interest in the Joint Patent Rights
and Joint Know-How, solely to the extent necessary to allow Inovio, its
Affiliates or licensees to offer for sale and sell the applicable Termination
Product(s) in the applicable country(ies), provided that with respect to any
Roche IP Rights obtained pursuant to an agreement with a Third Party, Inovio
assumes all of Roche’s obligations (including payment obligations) under such
agreement to the extent applicable to the Termination Product(s). For clarity,
the licenses under this Section 15.3.3(d) shall not include any licenses that
Roche has with a Third Party for which such grant would be prohibited or under
which a member of the Roche Group would incur financial obligations to such
Third Party.

 

- 54 -

--------------------------------------------------------------------------------

15.3.4 Other Obligations

 

  15.3.4.1 Obligations Related to Ongoing Activities

If Inovio does not provide timely Continuation Election Notice, then Roche shall
have the right to cancel all ongoing obligations.

If Inovio provides such timely Continuation Election Notice, then from the date
of notice of termination until the effective date of termination, Roche shall
continue activities, including preparatory activities, ongoing as of the date of
notice of termination. However, Roche shall not be obliged to initiate any new
activities not ongoing at the date of notice of termination.

After the effective date of termination, Roche shall not have any obligation to
perform and/or complete any activities or to make any payments for performing or
completing any activities under this Agreement, except as expressly stated
herein.

Notwithstanding the foregoing, in case of any termination, upon the request of
the Party taking responsibility for a Termination Product, if the other Party is
conducting a Clinical Study for such Termination Product, then such Party shall
complete any Clinical Study related to the Termination Product that is being
conducted under its IND for the Termination Product and is ongoing as of the
effective date of termination; provided, however, that

 

a) both Inovio and Roche in their reasonable judgment have concluded that
completing any such Clinical Studies does not present an unreasonable risk to
patient safety;

 

b) neither Party shall have any obligation to recruit or enroll any additional
patients after the date of termination; and

 

c) the Party taking responsibility for the Termination Product agrees to
reimburse the other Party for all of its development costs that arise after the
effective date of termination in completing such Clinical Studies.

 

  15.3.4.2 Obligations Related to Manufacturing

 

  a) Clinical Supplies

In the case of termination by Inovio according to Section 15.2.1 or 15.2.2 or by
Roche under Section 15.2.3, if Inovio elects to develop the Product(s), to the
extent that Roche is the party responsible for the manufacture of the
Termination Product, Roche shall transfer all existing and available clinical
material to Inovio at Roche’s fully burdened manufacturing cost. Roche shall
have no obligation to perform any additional activities concerning the clinical
supplies (e.g. retesting, analyses). Inovio shall assume all liability for the
use of such material. In the case of termination by Roche according to
Section 15.2.1 or 15.2.2, to the extent that Inovio is responsible for
manufacture of a Termination Product, Inovio will continue to manufacture such
Terminated Product for Roche, on the terms agreed to herein, unless Roche elects
to exercise its right of portability set forth in Section 5.3.4, which right
shall survive.

 

  b) Commercial Supplies

In the case of termination by Inovio according to Section 15.2.1 or 15.2.2 or by
Roche under Section 15.2.3, if a Product is marketed in any country of Territory
on the date of the notice of termination of this Agreement, upon the request of
Inovio, to the extent that Roche is the party responsible for the manufacture of
the Termination Product, Roche shall manufacture and supply such Product to
Inovio for a period that shall not exceed eighteen (18) months from the
effective date of the termination of this Agreement at a price to be agreed by
the Parties in good faith. Inovio shall use Commercially Reasonable Efforts to
take over the manufacturing as soon as possible after the effective date of
termination. In the case of termination by Roche according to Section 15.2.1 or
15.2.2, to the extent that Inovio is

 

- 55 -

--------------------------------------------------------------------------------

responsible for manufacture of a Termination Product, Inovio will continue to
manufacture such Terminated Product for Roche, on the terms agreed to herein,
unless Roche elects to exercise its right of portability set forth in
Section 5.3.4, which right shall survive.

Unless otherwise agreed by the Parties, the termination of this Agreement shall
cause the automatic termination of all ancillary agreements related hereto, if
any.

 

  15.3.4.3 Royalty and Payment Obligations

Termination of this Agreement by a Party, for any reason, shall not release
Roche from any obligation to pay royalties or make any payments to Inovio that
were due and payable prior to the effective date of termination. Unless
otherwise expressly provided for herein, termination of this Agreement by a
Party, for any reason, will release Roche from any obligation to pay royalties
or make any payments to Inovio that would otherwise become due or payable after
the effective date of termination.

 

15.4 Survival

Section 3.5 (Retained Rights), Section 10.1 (Ownership of Inventions); Article
12 (Indemnification), Article 14 (Obligation Not to Disclose Confidential
Information), Article 15 (Term and Termination), Section 16.2 (Governing Law)
and Section 16.5 (Arbitration) shall survive any expiration or termination of
this Agreement for any reason.

 

16. Miscellaneous

 

16.1 Bankruptcy

All licenses (and to the extent applicable rights) granted under or pursuant to
this Agreement by Inovio to Roche are, and shall otherwise be deemed to be, for
purposes of Section 365(n) of Title 11, US Code (the “Bankruptcy Code”) licenses
of rights to “intellectual property” as defined under Section 101(60) of the
Bankruptcy Code. Unless Roche elects to terminate this Agreement, the Parties
agree that Roche, as a licensee or sublicensee of such rights under this
Agreement, shall retain and may fully exercise all of its rights and elections
under the Bankruptcy Code, subject to the continued performance of its
obligations under this Agreement.

 

16.2 Change of Control

If there is a Change of Control of Inovio, then Inovio shall provide written
notice to Roche at least thirty (30) days prior to completion of such Change of
Control, subject to any confidentiality obligations of Inovio then in effect
(but in any event shall notify Roche within fifteen (15) days after completion
of such Change of Control).

The Change of Control Group in connection with such Change of Control shall
agree in writing with Roche that it will not utilize any of Roche’s Know-How,
Patent Rights, Inventions, Materials or Confidential Information or Joint
Know-How, Joint Patent Rights or Collaboration IP (collectively, “Sensitive
Information”) for the research, development or commercialization of any product
for the treatment of any indication or patient population for which a Product
may be developed or commercialized.

Following consummation of the Change of Control, Roche and the Change of Control
Group shall adopt in writing reasonable procedures to prevent the disclosure of
Sensitive Information beyond Inovio’s personnel who need to know the Sensitive
Information solely for the purpose of fulfilling the Acquired Party’s
obligations under this Agreement.

If there is a Change of Control of Inovio then Roche may, in its sole
discretion, cause Inovio to immediately cease any work under the Research Plans.
Upon any such ceasation, Inovio will

 

- 56 -

--------------------------------------------------------------------------------

immediately cease all activity, transfer to Roche all data developed by Inovio,
and reconcile actual FTE costs in the quarter against the quarterly prepayment
made by Roche. Within thirty (30) days of such reconciliation, Inovio will
refund to Roche the difference between the quarterly prepayment by Roche and
Inovio actual FTE expenditures in the quarter. All licenses granted by Roche to
Inovio shall terminate, except the license granted by Roche to Inovio under
Section 3.3, above, shall survive . In addition, Roche shall have the right to
suspend Inovio or its successor’s participation and rights under Article 4, and
Roche shall have the right to make all decisions under the Agreement
unilaterally and without consultation with Inovio or its successor.

 

16.3 Governing Law

This Agreement shall be governed by and construed in accordance with the laws of
New Jersey, without reference to its conflict of laws principles.

 

16.4 Disputes

Unless otherwise set forth in this Agreement, in the event of any dispute in
connection with this Agreement, such dispute shall be referred to the respective
executive officers of the Parties designated below or their designees, for good
faith negotiations attempting to resolve the dispute. The designated executive
officers are as follows:

 

For Inovio:    CEO For Roche:    Head of Roche Partnering

 

16.5 Arbitration

Should the Parties fail to agree within two (2) months after such dispute has
first arisen, it shall be finally settled by arbitration in accordance with the
Rules of American Arbitration Association (AAA) as in force at the time when
initiating the arbitration. The tribunal shall consist of three arbitrators.
Each Party shall select one (1) arbitrator and the arbitrators shall select the
third arbitrator. The place of arbitration shall be Newark, New Jersey, US. The
language to be used shall be English.

 

16.6 Assignment

Neither Party may assign its rights or obligations under this Agreement absent
the prior written consent of the other Party, except to any of its Affiliates or
in the context of a merger, acquisition, sale or other transaction involving all
or substantially all of the assets of the Party seeking to assign, provided
that, in the case of an assignment to an Affiliate, the assigning Party shall be
responsible for the actions of its Affiliates, in which case such Party in its
sole discretion may assign its rights and obligations under this Agreement. Any
permitted assignment shall be binding on the successors of the assigning Party.

 

16.7 Debarment

Inovio represents and warrants that it has never been debarred under 21 U.S.C.
§335a, disqualified under 21 C.F.R. §312.70 or §812.119, sanctioned by a Federal
Health Care Program (as defined in 42 U.S.C §1320 a-7b(f)), including without
limitation the federal Medicare or a state Medicaid program, or debarred,
suspended, excluded or otherwise declared ineligible from any other similar
Federal or state agency or program. In the event Inovio receives notice of
debarment, suspension, sanction, exclusion, ineligibility or disqualification
under the above-referenced statutes, Inovio shall immediately notify Roche in
writing and Roche shall have the right, but not the obligation, to terminate
this Agreement, effective, at Roche’s option, immediately or at a specified
future date.

 

16.8 Independent Contractor

No employee or representative of either Party shall have any authority to bind
or obligate the other Party to this Agreement for any sum or in any manner
whatsoever or to create or impose

 

- 57 -

--------------------------------------------------------------------------------

any contractual or other liability on the other Party without said Party’s prior
written approval. For all purposes, and notwithstanding any other provision of
this Agreement to the contrary, Inovio legal relationship to Roche under this
Agreement shall be that of independent contractor.

 

16.9 Unenforceable Provisions and Severability

If any of the provisions of this Agreement are held to be void or unenforceable,
then such void or unenforceable provisions shall be replaced by valid and
enforceable provisions that will achieve as far as possible the economic
business intentions of the Parties. However the remainder of this Agreement will
remain in full force and effect, provided that the material interests of the
Parties are not affected, i.e. the Parties would presumably have concluded this
Agreement without the unenforceable provisions.

 

16.10 Waiver

The failure by either Party to require strict performance and/or observance of
any obligation, term, provision or condition under this Agreement will neither
constitute a waiver thereof nor affect in any way the right of the respective
Party to require such performance and/or observance. The waiver by either Party
of a breach of any obligation, term, provision or condition hereunder shall not
constitute a waiver of any subsequent breach thereof or of any other obligation,
term, provision or condition.

 

16.11 Appendices

All Appendices to this Agreement shall form an integral part to this Agreement.

 

16.12 Entire Understanding

This Agreement contains the entire understanding between the Parties hereto with
respect to the within subject matter and supersedes any and all prior
agreements, understandings and arrangements, whether written or oral.

 

16.13 Amendments

No amendments of the terms and conditions of this Agreement shall be binding
upon either Party hereto unless in writing and signed by both Parties.

 

16.14 Invoices

All invoices that are required or permitted hereunder shall be in writing and
sent by Inovio to Roche at the following address or other address as Roche may
later provide:

F. Hoffmann-La Roche Ltd

Kreditorenbuchhaltung

4070 Basel

Switzerland

With a copy to the Roche Alliance Director as directed by Roche.

 

- 58 -

--------------------------------------------------------------------------------

16.15 Notice

All notices that are required or permitted hereunder shall be in writing and
sufficient if delivered personally, sent by facsimile (and promptly confirmed by
personal delivery, registered or certified mail or overnight courier), sent by
nationally recognized overnight courier or sent by registered or certified mail,
postage prepaid, return receipt requested, addressed as follows:

 

if to Inovio, to:      

Inovio Pharmaceuticals, Inc.

1787 Sentry Parkway West, Building 18, Suite 400

Blue Bell, Pennsylvania 19422 U.S.A.

Attn: Niranjan Sardesai, COO

Facsimile No.: 267-440-4242

And:   

Attn: Legal Department

Facsimile No.: 267-440-4242

if to Roche, to:   

F. Hoffmann-La Roche Ltd

Grenzacherstrasse 124

4070 Basel

Switzerland

Attn: Legal Department

Facsimile No.: +41 61 688 13 96

And:   

Hoffmann-La Roche Inc.

340 Kingsland Street

Nutley, New Jersey 07110

U.S.A.

Attn. Corporate Secretary

Facsimile No.: +1 973 235-3500

or to such other address as the Party to whom notice is to be given may have
furnished to the other Party in writing in accordance herewith.

[Signature Page Follows]

 

- 59 -

--------------------------------------------------------------------------------

IN WITNESS WHEREOF, the Parties have entered into this Agreement as of the
Effective Date.

 

Inovio Pharmaceuticals, Inc.      

/s/ J. Joseph Kim

      Name:   J. Joseph Kim, Ph.D.       Title:   President and CEO       F.
Hoffmann-La Roche Ltd      

/s/ Christophe Carissimo

   

/s/ Melanie Frey Wick

Name:   Christophe Carissimo     Name:   Dr. Melanie Frey Wick Title:   Global
Licensing Director     Title:   Vice Director Hoffmann-La Roche Inc.      

/s/ John P. Parise

      Name:   John J. Parise       Title:   Authorized Signatory      

 

- 60 -

--------------------------------------------------------------------------------

Appendix 1.54

Inovio Background Patent Rights

INOVIO PATENT/IP SCHEDULE

 

1 PATENT RIGHTS TO DELIVERY DEVICES

 

A. Electroporation

 

1) CELLECTRA®

 

2) SKIN/MUSCLE

 

3) SKIN

 

4) MUSCLE

 

5) ONCOLOGY - TUMORS

 

6) OTHER

 

2 PATENT RIGHTS TO ENABLING TECHNOLOGIES

 

A. Vaccine Additives

 

1. ADJUVANTS

IL-15

IL-15 R-ALPHA

CTACK, MEK, TECK

RANTES

IL-28

IL-12

 

  1. FORMULATIONS

PLG - LIPID ADDITIVES

PLG - LYOPHILIZATION FORMULA

 

B. Functional DNA

 

1. PLASMIDS

 

2. LEADER SEQUENCES

 

3. PROMOTERS

 

3 Patent rights to ProducTs

 

1 Hepatitis B

 

2 Prostate cancer

--------------------------------------------------------------------------------

1 PATENT RIGHTS TO DELIVERY DEVICES

 

A. Electroporation

 

1. CELLECTRA®

AVSI-0010 - ELECTRODE ASSEMBLY FOR CONSTANT-CURRENT ELECTROPORATION AND USE

AVSI-0048 - ELECTROPORATION DEVICES AND METHODS OF USING SAME FOR
ELECTROPORATION OF CELLS IN MAMMALS

 

Inovio Ref

 

Country

 

Status

 

Serial Number

 

Filing Date

 

Patent No.

 

Issue Date

AVSI0010   AU   Granted   2009251157   23-Dec-2009   2009251157   09-Aug-2012
AVSI0010   CA   Published   2477870   06-Mar-2003     AVSI0010   EP   Published
  03717937.1   06-Mar-2003     AVSI0010   MX   Granted   PA/A/2004/008670  
06-Mar-2003   263479   06-Jan-2009 AVSI0010   SG   Granted   200405195-9  
06-Mar-2003   106747   29-Sep-2006 AVSI0010   TW   Granted   92104867  
06-Mar-2003   239855   21-Sep-2005 AVSI0010   US   Granted   10/360768  
07-Mar-2002   7245963   17-Jul-2007 AVSI0010   US   Granted   11/495021  
28-Jul-2006   7664545   16-Feb-2010 AVSI0010   WO   Reportable   PCT/US03/06833
  06-Mar-2003     AVSI0010 P1   CA   Allowed   2578847   03-Sep-2004    
AVSI0010 P1   EP   Published   04788598.3   03-Sep-2004     AVSI0010 P1   TW  
Granted   93127152   08-Sep-2004   246930   11-Jan-2006 AVSI0010 P1   US  
Granted   10/657725   08-Sep-2003   8209006   26-Jun-2012 AVSI0010 P1   WO  
Reportable   PCT/US04/28998   03-Sep-2004     AVSI0048   AU   Granted  
2007313203   17-Oct-2007   2007313203   29-Nov-2012 AVSI0048   CA   Published  
2666501   17-Oct-2007     AVSI0048   CN   Published   200780046652.7  
17-Oct-2007    

 

- 62 -

--------------------------------------------------------------------------------

AVSI0048   EP   Published   07839621.5   17-Oct-2007     AVSI0048   EP  
Published   11184546.7   10-Oct-2011     AVSI0048   HK   Published   09111461.8
  08-Dec-2009     AVSI0048   IN   Pending   2366/DELNP/2009   17-Oct-2007    
AVSI0048   JP   Published   2009-533358   15-Jun-2009     AVSI0048   KR  
Pending   2009-7007847   17-Oct-2007     AVSI0048   SG   Pending   200902629-5  
17-Oct-2007     AVSI0048   SG   Granted   201107493-7   12-Oct-2011   175627  
15-Apr-2013 AVSI0048   US   Published   11/874072   17-Oct-2007     AVSI0048  
WO   Reportable   PCT/US07/022139   17-Oct-2007    

 

- 63 -

--------------------------------------------------------------------------------

2. SKIN/MUSCLE

GTI-1130 - SKIN AND MUSCLE-TARGETED GENE THERAPY BY PULSED ELECTRICAL FIELD

GTI-2010 - VARIABLE CURRENT DENSITY SINGLE NEEDLE ELECTROPORATION SYSTEM AND
METHOD

VGX0118 - Multiple Tissue Layer Electroporation Applicator and Device

SPHERG1 - method of transferring nucleic acid into multicelled eukaryotic cells
and combination therefor

 

Inovio Ref

 

Country

 

Status

 

Serial Number

 

Filing Date

 

Patent No.

 

Issue Date

GTI-1130   AU   Granted   49883/99   13-Jul-1999   770092   27-May-2004 GTI-1130
  CA   Granted   2337652   13-Jul-1999   2337652   26-Mar-2013 GTI-1130   EP  
Published   99933937.7   13-Jul-1999     GTI-1130   EP   Published   11180420.9
  07-Sep-2011     GTI-1130   EP   Published   11180419.1   07-Sep-2011    
GTI-1130   US   Granted   09/352809   13-Jul-1999   6697669   24-Feb-2004
GTI-1130   US   Granted   10/165657   07-Jun-2002   6678556   13-Jan-2004
GTI-1130   US   Granted   10/756946   13-Jan-2004   7570992   04-Aug-2009
GTI-1130   US   Granted   09/625825   26-Jul-2000   6654636   25-Nov-2003
GTI-1130   US   Granted   10/233007   30-Aug-2002   6972013   06-Dec-2005
GTI-1130   US   Granted   11/291459   30-Nov-2005   7922709   12-Apr-2011
GTI-2010   AU   Published   2009205643   16-Jan-2009     GTI-2010   CA  
Published   2710408   16-Jan-2009     GTI-2010   CN   Published   200980103021.3
  16-Jan-2009     GTI-2010   EP   Published   09702445.9   16-Jan-2009    
GTI-2010   HK   Published   11106149.4   15-Jun-2011    

 

- 64 -

--------------------------------------------------------------------------------

GTI-2010   IN   Published   4726/DELNP/2010   30-Jun-2010     GTI-2010   JP  
Published   2010-543139   16-Jan-2009     GTI-2010   KR   Pending  
10-2010-7018104   16-Aug-2010     GTI-2010   US   Published   12836163  
14-Jul-2010     GTI-2010   WO   Published   PCT/US2009/000273   16-Jan-2009    
VGX0118   AU   Published   2011223768   01-Mar-2011     VGX0118   CA   Published
  2789733   01-Mar-2011     VGX0118   EP   Published   11751203.8   01-Mar-2011
    VGX0118   KR   Pending   10-2012-7025737   01-Mar-2011     VGX0118   US  
Expired   61309423   01-Mar-2010     VGX0118   US   Expired   61309860  
02-Mar-2010     VGX0118   US   Published   13581700   29-Aug-2012     VGX0118  
WO   Published   PCT/US2011/026688   01-Mar-2011     SPHERG1   US   Granted    
2000-02-02   6528315   04-Mar-2003 SPHERG1  

EP BE,

CH,DE, FR, GB, IT

  Granted   1998935066   1998-06-30   EP0991425   12-Apr-2000

 

3. SKIN

GTI-1530 - Applicator for the electroporation of drugs and genes into surface
cells

GTI-3010 - Contactless Electropermeabilization Electrode and Method

VGX0117 - A Tolerable and Minimally Invasive Skin Electroporation Device

VGX0123 - A NONINVASIVE DERMAL ELECTROPORATION DEVICE

USF-A3 - ELECTROMANIPULATION DEVICE AND METHOD

 

Inovio Ref

 

Country

 

Status

 

Serial Number

 

Filing Date

 

Patent No.

 

Issue Date

GTI-1530   AT   Granted   99966432.9   17-Dec-1999   1140283   08-Mar-2006

 

- 65 -

--------------------------------------------------------------------------------

GTI-1530   AU   Granted   14354/95   13-Dec-1994   691237   27-Aug-1998 GTI-1530
  AU   Granted   68821/98   02-Apr-1998   741399   14-Mar-2002 GTI-1530   AU  
Granted   21969/00   17-Dec-1999   763535   06-Nov-2003 GTI-1530   CA   Granted
  2185024   13-Dec-1994   2185024   08-May-2001 GTI-1530   CA   Granted  
2311474   02-Apr-1998   2311474   02-Oct-2012 GTI-1530   CH   Granted  
99966432.9   17-Dec-1999   1140283   08-Mar-2006 GTI-1530   DE   Granted  
95905926.2   13-Dec-1994   P69426210.2   25-Oct-2000 GTI-1530   DE   Granted  
98914475.3   02-Apr-1998   69806794.0   24-Jul-2002 GTI-1530   DE   Granted  
99966432.9   17-Dec-1999   1140283   08-Mar-2006 GTI-1530   EP   Granted  
95905926.2   13-Dec-1994   0751802   25-Oct-2000 GTI-1530   EP   Granted  
98914475.3   02-Apr-1998   1028777   24-Jul-2002 GTI-1530   EP   Granted  
99966432.9   17-Dec-1999   1140283   08-Mar-2006 GTI-1530   ES   Granted  
99966432.9   17-Dec-1999   1140283   08-Mar-2006 GTI-1530   FR   Granted  
95905926.2   13-Dec-1994   0751802   25-Oct-2000 GTI-1530   FR   Granted  
98914475.3   02-Apr-1998   1028777   24-Jul-2002 GTI-1530   FR   Granted  
99966432.9   17-Dec-1999   1140283   08-Mar-2006 GTI-1530   GB   Granted  
95905926.2   13-Dec-1994   0751802   25-Oct-2000 GTI-1530   GB   Granted  
98914475.3   02-Apr-1998   1028777   24-Jul-2002 GTI-1530   GB   Granted  
99966432.9   17-Dec-1999   1140283   08-Mar-2006 GTI-1530   IT   Granted  
95905926.2   13-Dec-1994   0751802   25-Oct-2000 GTI-1530   IT   Granted  
99966432.9   17-Dec-1999   1140283   08-Mar-2006 GTI-1530   JP   Granted  
525651/95   13-Dec-1994   3554935   21-May-2004

 

- 66 -

--------------------------------------------------------------------------------

GTI-1530   NL   Granted   99966432.9   17-Dec-1999   1140283   08-Mar-2006
GTI-1530   TW   Granted   87106879   05-May-1998   NI-108036   01-Sep-1999
GTI-1530   US   Granted   08/310647   22-Sep-1994   5464386   07-Nov-1995
GTI-1530   US   Granted   08/552200   02-Nov-1995   5688233   18-Nov-1997
GTI-1530   US   Granted   08/964436   04-Nov-1997   6009345   28-Dec-1999
GTI-1530   US   Granted   09/213782   17-Dec-1998   5968006   19-Oct-1999
GTI-3010   CA   Published   2756276   16-Apr-2010     GTI-3010   EP   Published
  10765277.8   16-Apr-2010     GTI-3010   KR   Pending   10-2011-7027142  
16-Apr-2010     GTI-3010   US   Published   13263802   10-Oct-2011     GTI-3010
  WO   Published   PCT/US10/31431   16-Apr-2010     VGX0117   AU   Published  
2011223753   01-Mar-2011     VGX0117   BR   Pending   11 2012 0218050  
01-Mar-2011     VGX0117   CA   Published   2789736   01-Mar-2011     VGX0117  
CN   Published   201180011473.6   01-Mar-2011     VGX0117   EA   Pending  
201201203   01-Mar-2011     VGX0117   EP   Published   11751208.7   01-Mar-2011
    VGX0117   HK   Pending   201180011473.6   01-Mar-2011     VGX0117   IN  
Pending   7555/DELNP/2012   01-Mar-2011     VGX0117   JP   Published  
2012556176   01-Mar-2011     VGX0117   KR   Pending   10-2012-7025208  
01-Mar-2011     VGX0117   MX   Pending   MX/a/2012/009986   01-Mar-2011    

 

- 67 -

--------------------------------------------------------------------------------

VGX0117   US   Expired   61309422   01-Mar-2010     VGX0117   US   Published  
13581702   05-Oct-2012     VGX0117   ZA   Pending   201206478   01-Mar-2011    
VGX0117   WO   Published   PCT/US11/26701   01-Mar-2011     VGX0123   US  
Expired   61402712   28-Jun-2011     VGX0123   WO   Published   PCT/US12/44539  
28-Jun-2012     USF-A3   CA   Published   2478614   13-Mar-2002     USF-A3   US
  Granted   10605126   10-Sep-2003   7769440   03-Aug-2010

 

4. MUSCLE

GTI-1370 - METHOD AND APPARATUS FOR REDUCING ELECTROPORATION-MEDIATED MUSCLE
REACTION AND PAIN RESPONSE

GTI-5000 - METHOD FOR INTRODUCING PHARMACEUTICAL DRUGS AND NUCLEIC ACIDS INTO
SKELETAL MUSCLE

GTI-5001 - ELECTROPORATION DEVICE AND INJECTION APPARATUS

GTI-7001 - DEVICE AND METHOD FOR SINGLE-NEEDLE IN VIVO ELECTROPORATION

spherg2 - method of transferring nucleic acid into straited muscles

 

Inovio Ref

 

Country

 

Status

 

Serial Number

 

Filing Date

 

Patent No.

 

Issue Date

GTI-1370   AU   Granted   41771/00   23-Mar-2000   778736   14-Apr-2005 GTI-1370
  EP   Published   00921451.1   23-Mar-2000     GTI-1370   TW   Granted  
89105497   11-Apr-2000   NI-153798   06-Aug-2002 GTI-1370   US   Granted  
10/215963   08-Aug-2002   7054685   30-May-2006 GTI-1370   US   Granted  
09/535683   23-Mar-2000   6678558   13-Jan-2004

 

- 68 -

--------------------------------------------------------------------------------

GTI-5000   AT   Granted   98909691.2   03-Apr-1998   1023107   30-Aug-2006
GTI-5000   AU   Granted   69906/98   03-Apr-1998   733628   30-Aug-2001 GTI-5000
  BE   Granted   98909691.2   03-Apr-1998   1023107   30-Aug-2006 GTI-5000   CA
  Granted   2285056   03-Apr-1998   2285056   14-Dec-2004 GTI-5000   CH  
Granted   98909691.2   03-Apr-1998   1023107   30-Aug-2006 GTI-5000   CN  
Granted   98803980.X   03-Apr-1998   ZL98803980   24-Apr-2006 GTI-5000   DE  
Granted   98909691.2   03-Apr-1998   69835761.2   30-Aug-2006 GTI-5000   DK  
Granted   98909691.2   03-Apr-1998   1023107   30-Aug-2006 GTI-5000   EA  
Granted   199900882   03-Apr-1998   002087   24-Dec-2001 GTI-5000   EP   Granted
  98909691.2   03-Apr-1998   1023107   30-Aug-2006 GTI-5000   ES   Granted  
98909691.2   03-Apr-1998   1023107   30-Aug-2006 GTI-5000   FR   Granted  
98909691.2   03-Apr-1998   1023107   30-Aug-2006 GTI-5000   GB   Granted  
98909691.2   03-Apr-1998   1023107   30-Aug-2006 GTI-5000   IE   Granted  
98909691.2   03-Apr-1998   1023107   30-Aug-2006 GTI-5000   IT   Granted  
98909691.2   03-Apr-1998   1023107   30-Aug-2006 GTI-5000   KR   Granted  
1999-7009009   03-Apr-1998   427786   07-Apr-2004 GTI-5000   KZ   Granted  
199900882   03-Apr-1998   2087   24-Dec-2001 GTI-5000   LU   Granted  
98909691.2   03-Apr-1998   1023107   30-Aug-2006 GTI-5000   MX   Granted  
999026   03-Apr-1998   253159   09-Jan-2008 GTI-5000   NL   Granted   98909691.2
  03-Apr-1998   1023107   30-Aug-2006 GTI-5000   NO   Granted   19994820  
03-Apr-1998   327806   28-Sep-2009 GTI-5000   NZ   Granted   337853  
03-Apr-1998   337853   08-Jul-2002 GTI-5000   RU   Granted   199900882  
03-Apr-1998   2087   24-Dec-2001

 

- 69 -

--------------------------------------------------------------------------------

GTI-5000   SE   Granted   98909691.2   03-Apr-1998   1023107   30-Aug-2006
GTI-5000   US   Granted   09/565140   05-May-2000   6261281   17-Jul-2001
GTI-5000   US   Granted   09/055084   03-Apr-1998   6110161   29-Aug-2000
GTI-5000   US   Granted   10/141561   07-May-2002   6610044   26-Aug-2003
GTI-5000   US   Granted   10/620271   14-Jul-2003   6958060   25-Oct-2005
GTI-5000   US   Granted   12/070233   15-Feb-2008   7931640   26-Apr-2011
GTI-5000   WO   Reportable   IB9800487   03-Apr-1998     GTI-5000   WO  
Reportable   2001GB01970   04-May-2001     GTI-5001   AU   Granted   2009202678
  01-Jul-2009   2009202678   29-Nov-2012 GTI-5001   CA   Published   2491000  
04-Jul-2003     GTI-5001   CN   Granted   03820724.9   04-Jul-2003   03820724.9
  28-Apr-2010 GTI-5001   EA   Granted   200401558   04-Jul-2003   009203  
28-Dec-2007 GTI-5001   EP   Allowed   03762794.0   04-Jul-2003     GTI-5001   HK
  Published   05108751.7   04-Jul-2003     GTI-5001   IN   Pending  
4137/DELNP/2004   04-Jul-2003     GTI-5001   JP   Granted   2004-518966  
04-Jul-2003   4461012   19-Feb-2010 GTI-5001   JP   Published   2009-279074  
09-Dec-2009     GTI-5001   MX   Granted   PA/A/2005/000155   04-Jul-2003  
277428   21-Jul-2010 GTI-5001   NZ   Granted   562306   04-Jul-2003   562306  
08-Oct-2009 GTI-5001   NZ   Granted   566578   04-Jul-2003   566578  
12-Nov-2009 GTI-5001   RU   Granted   200401558   04-Jul-2003   9203  
28-Dec-2007 GTI-5001   US   Granted   10/612304   03-Jul-2003   7328064  
05-Feb-2008

 

- 70 -

--------------------------------------------------------------------------------

GTI-5001   US   Published   11/985825   16-Nov-2007     GTI-5001   WO  
Reportable   PCT/GB2003/002887   04-Jul-2003     GTI-5001   ZA   Granted  
2005/0058   04-Jul-2003   2005/0058   29-Mar-2006 GTI-7001   AU   Granted  
2007215263   09-Feb-2007   2007215263   20-Oct-2011 GTI-7001   CA   Published  
2635437   09-Feb-2007     GTI-7001   CA   Pending   2686855   16-May-2008    
GTI-7001   CN   Granted   200780002313.9   09-Feb-2007   200780002313.9  
25-Dec-2012 GTI-7001   EP   Published   07750450.4   09-Feb-2007     GTI-7001  
EP   Published   08767759.7   20-Nov-2009     GTI-7001   IN   Pending  
6100/DELNP/2008   11-Jul-2008     GTI-7001   JP   Granted   2008-554405  
09-Feb-2007   5059786   10-Aug-2012 GTI-7001   KR   Published   7019463/2008  
09-Feb-2007     GTI-7001   MX   Granted   MX/a/2008/008981   09-Feb-2007  
311676   24-Jul-2013 GTI-7001   NO   Pending   20083811   09-Feb-2007    
GTI-7001   US   Published   11/704591   09-Feb-2007     GTI-7001   WO  
Reportable   PCT/US2007/003615   09-Feb-2007     GTI-7001   WO   Reportable  
PCT/US2008/006311   16-May-2008     SPHERG2   US   Granted     2001-11-07  
6939862   06-Sep-2005 SPHERG2  

EP BE,

CH,DE, FR, GB, IT

  Granted   1998935067   1998-06-30   EP0991426   12-Apr-2000

 

- 71 -

--------------------------------------------------------------------------------

5. ONCOLOGY-TUMORS

GTI-1110 - Synergism of photodynamic and electropermeation effect on cell
vitality as a novel cytotoxic agent

GTI-1160 - ELECTROPORATION SYSTEM WITH VOLTAGE CONTROL FEEDBACK FOR CLINICAL
APPLICATIONS

GTI-1200 - Apparatus for addressing needle array electrodes for electroporation
therapy

GTI-1230 - Electrically induced vessel vasodilation

GTI-1250 - ELECTROPORATION APPARATUS WITH CONNECTIVE ELECTRODE TEMPLATE

GTI-1360 - Method of electroporation-enhanced delivery of active agents

 

Inovio Ref

 

Country

 

Status

 

Serial Number

 

Filing Date

 

Patent No.

 

Issue Date

GTI-1110

  US   Granted   10677214   01-Oct-2003   7181271   20-Feb-2007

GTI-1160

  CA   Granted   2216131   10-Apr-1995   2216131   05-Feb-2002

GTI-1160

  CA   Granted   2218255   22-May-1996   2218255   20-Nov-2001

GTI-1160

  CN   Granted   96194608.3   22-May-1996   ZL96194608.3   26-May-2004

GTI-1160

  DE   Granted   02008920.7   10-Apr-1995   1240917   23-Jun-2004

GTI-1160

  DE   Granted   96916550.5   22-May-1996   69604509.5   29-Sep-1999

GTI-1160

  EP   Granted   02008920.7   10-Apr-1995   1240917   23-Jun-2004

GTI-1160

  EP   Granted   96916550.5   22-May-1996   0874663   29-Sep-1999

GTI-1160

  FR   Granted   02008920.7   10-Apr-1995   1240917   23-Jun-2004

GTI-1160

  FR   Granted   96916550.5   22-May-1996   0874663   29-Sep-1999

GTI-1160

  GB   Granted   02008920.7   10-Apr-1995   1240917   23-Jun-2004

GTI-1160

  GB   Granted   96916550.5   22-May-1996   0874663   29-Sep-1999

GTI-1160

  JP   Granted   530968/96   10-Apr-1995   3338880   16-Aug-2002

GTI-1160

  KR   Granted   706014/97   10-Apr-1995   247255   10-Dec-1999

GTI-1160

  KR   Granted   708424/97   22-May-1996   260238   04-Apr-2000

GTI-1160

  MX   Granted   PA/A/1997/006929   10-Apr-1995   218786   21-Jan-2004

 

- 72 -

--------------------------------------------------------------------------------

GTI-1160

  MX   Granted   PA/A/1997/008316   22-May-1996   248023   13-Aug-2007

GTI-1160

  US   Granted   08/467566   06-Jun-1995   5702359   30-Dec-1997

GTI-1160

  US   Granted   09/427151   25-Oct-1999   6451002   17-Sep-2002

GTI-1160

  US   Granted   10/053861   17-Jan-2002   6567694   20-May-2003

GTI-1160

  US   Granted   09/551327   18-Apr-2000   6418341   09-Jul-2002

GTI-1160

  US   Granted   90/005590   15-Dec-1999   5702359C1   28-Mar-2006

GTI-1160

  US   Granted   08/930168   10-Apr-1995   5810762   22-Sep-1998

GTI-1160

  US   Granted   08/042039   01-Apr-1993   5439440   08-Aug-1995

GTI-1160

  US   Granted   08/537265   29-Sep-1995   5993434   30-Nov-1999

GTI-1160

  US   Granted   10/177560   21-Jun-2002   6569149   27-May-2003

GTI-1160

  US   Granted   10/213514   06-Aug-2002   6763264   13-Jul-2004

GTI-1200

  AR   Granted   P990105331   21-Oct-1999   AR020932B1   30-May-2006

GTI-1200

  AU   Granted   86823/98   31-Jul-1998   734343   27-Sep-2001

GTI-1200

  AU   Granted   17074/00   21-Oct-1999   767814   11-Mar-2004

GTI-1200

  CA   Granted   2268026   31-Jul-1998   2268026   29-Jul-2003

GTI-1200

  CN   Granted   98801461.0   31-Jul-1998   98801461.0   07-Sep-2005

GTI-1200

  CN   Granted   200510084733.9   31-Jul-1998   1768873   28-Jan-2011

GTI-1200

  DE   Granted   98938256.9   31-Jul-1998   999867   08-Sep-2010

GTI-1200

  EP   Granted   98938256.9   31-Jul-1998   999867   08-Sep-2010

GTI-1200

  FR   Granted   98938256.9   31-Jul-1998   999867   08-Sep-2010

GTI-1200

  GB   Granted   98938256.9   31-Jul-1998   999867   08-Sep-2010

GTI-1200

  HK   Granted   00106147.9   31-Jul-1998   1027049   28-Apr-2006

 

- 73 -

--------------------------------------------------------------------------------

GTI-1200

  JP   Granted   2002-57679   31-Jul-1998   4180285   05-Sep-2008

GTI-1200

  KR   Granted   10-1999-7002781   31-Jul-1998   756252   31-Aug-2007

GTI-1200

  US   Granted   09/177678   22-Oct-1998   6241701   05-Jun-2001

GTI-1200

  US   Granted   09/861016   18-May-2001   6516223   04-Feb-2003

GTI-1200

  US   Granted   09/189062   09-Nov-1998   6233482   15-May-2001

GTI-1200

  US   Granted   09/189360   09-Nov-1998   6181964   30-Jan-2001

GTI-1200

  US   Granted   09/189070   09-Nov-1998   6068650   30-May-2000

GTI-1200

  US   Granted   08/905240   01-Aug-1997   6055453   25-Apr-2000

GTI-1200

  US   Granted   09/900601   05-Jul-2001   7412284   12-Aug-2008

GTI-1200

  US   Granted   09/227417   08-Jan-1999   6216034   10-Apr-2001

GTI-1200

  US   Granted   09/227416   08-Jan-1999   6014584   11-Jan-2000

GTI-1200

  ZA   Granted   98/7596   21-Aug-1998   98/7596   31-Aug-1999

GTI-1230

  US   Granted   09969367   01-Oct-2001   6865416   08-Mar-2005

GTI-1230

  US   Granted   09307216   07-May-1999   6347247   12-Feb-2002

GTI-1250

  US   Granted   09/206635   07-Dec-1998   6120493   19-Sep-2000

GTI-1250

  US   Granted   09/014291   27-Jan-1998   6009347   28-Dec-1999

GTI-1250

  US   Granted   09/234770   21-Jan-1999   6208893   27-Mar-2001

GTI-1360

  US   Granted   10/339708   08-Jan-2003   7171264   30-Jan-2007

GTI-1360

  US   Granted   09/567404   08-May-2000   6520950   18-Feb-2003

 

- 74 -

--------------------------------------------------------------------------------

6. OTHER

GTI-4010 - Oral Mucosal Electroporation Device and Use Thereof

GTI-9000 - METHODS OF ENHANCING IMMUNE RESPONSE USING ELECTROPORATION-ASSISTED
VACCINATION AND BOOSTING

 

Inovio Ref

 

Country

 

Status

 

Serial Number

 

Filing Date

 

Patent No.

 

Issue Date

GTI-4010

  CA   Pending   2795547   28-Apr-2011    

GTI-4010

  CN   Published   201180021234.9   28-Apr-2011    

GTI-4010

  EP   Published   11775553.8   28-Apr-2011    

GTI-4010

  HK   Pending   13108500.1   28-Apr-2011    

GTI-4010

  KR   Pending   10-2012-7027162   28-Apr-2011    

GTI-4010

  US   Published   13641977   18-Oct-2012    

GTI-4010

  WO   Published   PCT/US11/34277   28-Apr-2011    

GTI-9000

  AU   Allowed   2007322075   16-Nov-2007    

GTI-9000

  AU   Pending   2013206520   16-Nov-2007    

GTI-9000

  CA   Published   2668649   16-Nov-2007    

GTI-9000

  CN   Published   200780037742.X   16-Nov-2007    

GTI-9000

  EP   Published   07840065.2   16-Nov-2007    

GTI-9000

  HK   Published   10101823.9   22-Feb-2010    

GTI-9000

  JP   Published   2009-537218   16-Nov-2007    

GTI-9000

  KR   Published   7007135/2009   07-Apr-2009    

GTI-9000

  US   Published   11/985871   16-Nov-2007    

GTI-9000

  WO   Reportable   PCT/US2007/24051   16-Nov-2007    

 

- 75 -

--------------------------------------------------------------------------------

2. Patent rights to enabling technologies

 

A. Vaccine Additives

 

1. ADJUVANTS

UPVG0017 - VACCINES AND IMMUNOTHERAPEUTICS USING CODON OPTIMIZED IL-15 AND
METHODS FOR USING THE SAME

upVG0028 - VACCINES AND IMMUNOTHERAPEUTICS COMPRISING IL-15 RECEPTOR ALPHA
AND/OR NUCLEIC ACID MOLECULES ENCODING THE SAME, AND METHODS FOR USING THE SAME

UPVG0018 - IMPROVED VACCINES AND METHOD FOR USING THE SAME (CTACK, MEK, TECK)

UPVG0029 - Nucleic Acid Molecules Encoding Rantes, and Compositions and Methods
of Using The Same

UPVG0031 - Vaccines and Immunotherapeutics Comprising IL-28 and/or Nucleic Acid
Molecules Encoding the Same, and Methods for Using the Same

UPVG0041 - COMPOSITIONS, COMPRISING IMPROVED IL-12 GENETIC CONSTRUCTS AND
VACCINES, IMMUNOTHERAPEUTICS AND METHODS OF USING THE SAME

 

Inovio Ref

 

Country

 

Status

 

Serial Number

 

Filing Date

 

Patent No.

 

Issue Date

UPVG0017

  AU   Granted   2007208452   12-Jan-2007   2007208452   18-Oct-2012

UPVG0017

  CA   Published   2636867   12-Jan-2007    

UPVG0017

  CH   Granted   7762574.7   12-Jan-2007   1976871   16-Nov-2011

UPVG0017

  DE   Granted   7762574.7   12-Jan-2007   1976871   16-Nov-2011

UPVG0017

  DK   Granted   7762574.7   12-Jan-2007   1976871   16-Nov-2011

UPVG0017

  EP   Granted   7762574.7   12-Jan-2007   1976871   16-Nov-2011

UPVG0017

  ES   Granted   7762574.7   12-Jan-2007   1976871   16-Nov-2011

UPVG0017

  FR   Granted   7762574.7   12-Jan-2007   1976871   16-Nov-2011

UPVG0017

  GB   Granted   7762574.7   12-Jan-2007   1976871   16-Nov-2011

UPVG0017

  IN   Pending   2971/KOLNP/2008   12-Jan-2007    

UPVG0017

  JP   Allowed   2008-550435   12-Jan-2007    

UPVG0017

  KR   Pending   10-2008-7019727   12-Jan-2007    

 

- 76 -

--------------------------------------------------------------------------------

UPVG0017

  LU   Granted   7762574.7   12-Jan-2007   1976871   16-Nov-2011

UPVG0017

  MC   Granted   7762574.7   12-Jan-2007   1976871   16-Nov-2011

UPVG0017

  MX   Granted   MX/A/2008/008928   12-Jan-2007   296941   09-Mar-2012

UPVG0017

  NL   Granted   7762574.7   12-Jan-2007   1976871   16-Nov-2011

UPVG0017

  US   Granted   12160766   30-Mar-2009   8178660   15-May-2012

UPVG0017

  WO   Reportable   PCT/US07/000886   12-Jan-2007    

UPVG0028

  AU   Pending   PCT/US10/48827   14-Sep-2010    

UPVG0028

  CA   Pending   PCT/US10/48827   14-Sep-2010    

UPVG0028

  CN   Published   PCT/US10/48827   14-Sep-2010    

UPVG0028

  EP   Published   10816292.6   14-Sep-2010    

UPVG0028

  IN   Pending   406/MUMNP/2012   14-Sep-2010    

UPVG0028

  JP   Published   PCT/US10/48827   14-Sep-2010    

UPVG0028

  KR   Pending   10-2012-7006494   14-Sep-2010    

UPVG0028

  US   Published   13391615   21-Feb-2012    

UPVG0028

  WO   Published   PCT/US10/48827   14-Sep-2010    

UPVG0018

  US   Pending   13284824   28-Oct-2011    

UPVG0018

  WO   Reportable   PCT/US05/42231   18-Nov-2005    

UPVG0029

  AU   Pending   2011213559   08-Feb-2011    

UPVG0029

  CA   Pending   2788902   08-Feb-2011    

UPVG0029

  CN   Published   201180008582.2   08-Feb-2011    

UPVG0029

  EP   Published   11740539.9   08-Feb-2011    

UPVG0029

  IN   Pending   7013/DELNP/2012   08-Feb-2011    

UPVG0029

  JP   Published   2012-552154   08-Feb-2011    

UPVG0029

  KR   Pending   10-2012-7020794   08-Feb-2011    

UPVG0029

  US   Published   13577387   04-Ocy-2012    

 

- 77 -

--------------------------------------------------------------------------------

UPVG0029

  WO   Published   PCT/US11/24098   08-Feb-2011    

UPVG0031

  AU   Pending   2009231598   06-Apr-2009    

UPVG0031

  CA   Pending   2720168   06-Apr-2009    

UPVG0031

  CN   Published   200980112452.6   06-Apr-2009    

UPVG0031

  EP   Published   09726983.1   06-Apr-2009    

UPVG0031

  HK   Pending   11110692.7   10-Oct-2011    

UPVG0031

  IN   Published   3545/KOLNP/2010   06-Apr-2009    

UPVG0031

  JP   Published   2011-503239   06-Apr-2009    

UPVG0031

  KR   Pending   10-2010-7024735   06-Apr-2009    

UPVG0031

  US   Pending   12936192   01-Oct-2010    

UPVG0031

  WO   Published   PCT/US2009/039648   06-Apr-2009    

UPVG0041

  WO   Published   PCT/US12/69017   11-Dec-2012    

UPVG0041

  US   Expired   61569600   12-Dec-2011    

 

1. FORMULATIONS

PLG - AVSI-0021 - PLASMID MEDIATED GENE SUPPLEMENTATION AND IN VIVO EXPRESSION
OF THE POLY-L-GLUTAMATE SYSTEM

PLG - VAL1008 - FORMULATED NUCLEIC ACID COMPOSITIONS AND METHODS OF
ADMINISTERING THE SAME FOR GENE THERAPY

PLG - VAL1012 NUCLEIC ACID FORMULATIONS FOR GENE DELIVERY AND METHODS OF USE

PLG - VAL1001 - CATIONIC AMPHIPHILES

PLG - VAL1002 - CATIONIC LIPID: DNA COMPLEXES FOR GENE TARGETING

PLG - VAL1003 - AMPHIPHILIC BIGUANIDE DERIVATIVES

PLG - VAL1004 - IMPROVED METHODS OF DELIVERY USING CATIONIC LIPIDS AND HELPER
LIPIDS

PLG - VAL1005 - COMPOSITIONS AND METHODS USING NOVEL SUBSTITUTED IMIDAZOLIUM
LIPIDS

 

- 78 -

--------------------------------------------------------------------------------

PLG - VAL1006 - TRANSFORMATION OF CELLS ASSOCIATED WITH FLUID SPACES

PLG - VAL1010 PROTECTED ONE-VIAL FORMULATION FOR NUCLEIC ACID MOLECULES

 

Inovio Ref

 

Country

 

Status

 

Serial Number

 

Filing Date

 

Patent No.

 

Issue Date

AVSI0021 P1

  SG   Granted   200406924-1   23-May-2003   108408   29-Dec-2006

AVSI0021 P2

  KR   Pending   10-2010-7013178   15-Jun-2010    

VAL1001

  US   Granted   08/971951   17-Nov-1997   5902802   11-May-1999

VAL1002

  US   Granted   08/480923   07-Jun-1995   5932241   03-Aug-1999

VAL1003

  US   Granted   08/825854   04-Apr-1997   5958894   28-Sep-1999

VAL1004

  US   Granted   09/054769   03-Apr-1998   6235310   22-May-2001

VAL1005

  US   Granted   09/183634   30-Oct-1998   6121457   19-Sep-2000

VAL1005

  US   Granted   09/626268   25-Jul-2000   6245520   12-Jun-2001

VAL1006

  US   Granted   08/184547   21-Jan-1994   5792751   11-Aug-1998

VAL1008

  US   Granted   08/372213   13-Jan-1995   6040295   21-Mar-2000

VAL1008

  US   Granted   08/798974   11-Feb-1997   6514947   04-Feb-2003

VAL1010

  AT   Granted   99939113.9   10-Aug-1999   1104309   03-May-2006

 

- 79 -

--------------------------------------------------------------------------------

VAL1010

  CA   Granted   CA19992340416   10-Aug-1999   2340416   25-Aug-2009

VAL1010

  DE   Granted   99939113.9   10-Aug-1999   1104309   03-May-2006

VAL1010

  EP   Granted   99939113.9   10-Aug-1999   1104309   03-May-2006

VAL1010

  FR   Granted   99939113.9   10-Aug-1999   1104309   03-May-2006

VAL1010

  GB   Granted   99939113.9   10-Aug-1999   1104309   03-May-2006

VAL1010

  IE   Granted   99939113.9   10-Aug-1999   1104309   03-May-2006

VAL1010

  JP   Granted   2000-564589   10-Aug-1999   4538150   25-Jun-2010

VAL1010

  NL   Granted   99939113.9   10-Aug-1999   1104309   03-May-2006

VAL1010

  US   Granted   09/371619   10-Aug-1999   6534483   18-Mar-2003

VAL1012

  CA   Published   2401327   02-Mar-2001    

VAL1012

  CH   Granted   01918339   02-Mar-2001   1259265   01-Jun-2011

VAL1012

  DE   Granted   01918339   02-Mar-2001   1259265   01-Jun-2011

VAL1012

  DK   Granted   01918339   02-Mar-2001   1259265   01-Jun-2011

VAL1012

  EP   Granted   01918339   02-Mar-2001   1259265   01-Jun-2011

VAL1012

  ES   Granted   01918339   02-Mar-2001   1259265   01-Jun-2011

 

- 80 -

--------------------------------------------------------------------------------

VAL1012

  FR   Granted   01918339   02-Mar-2001   1259265   01-Jun-2011

VAL1012

  GB   Granted   01918339   02-Mar-2001   1259265   01-Jun-2011

VAL1012

  JP   Granted   2001-564801   02-Mar-2001   5253499   17-Apr-2012

VAL1012

  LU   Granted   01918339   02-Mar-2001   1259265   01-Jun-2011

VAL1012

  MC   Granted   01918339   02-Mar-2001   1259265   01-Jun-2011

VAL1012

  NL   Granted   01918339   02-Mar-2001   1259265   01-Jun-2011

VAL1012

  US   Granted   10/234406   03-Sep-2002   7173116   06-Feb-2007

VAL1012

  US   Granted   11/561847   20-Nov-2006   7491537   17-Feb-2009

 

- 81 -

--------------------------------------------------------------------------------

INOVIO PATENT/IP SCHEDULE

 

B) Functional DNA

 

1. PLASMIDS

AVSI-0013 - EXPRESSION VECTOR SYSTEMS AND METHOD OF USE

AVSI-0015 - FORMULATED NUCLEIC ACID COMPOSITIONS AND METHODS OF ADMINISTERING
THE SAME FOR GENE THERAPY

AVSI-0023 - CODON OPTIMIZED SYNTHETIC PLASMIDS

AVSI-0043 - OPTIMIZED HIGH YIELD SYNTHETIC PLASMIDS

 

Inovio Ref

 

Country

 

Status

 

Serial Number

 

Filing Date

 

Patent No.

 

Issue Date

AVSI0013

  US   Granted   08/472809   07-Jun-1995   5925564   20-Jul-1999

AVSI0015

  US   Granted   08/372213   13-Jan-1995   6,040,295   21-Mar-2000

AVSI0023

  AU   Granted   2003249208   15-Jul-2003   2003249208   18-Jun-2010

AVSI0023

  DE   Granted   03764596.7   15-Jul-2003   1543020   13-Apr-2011

AVSI0023

  EP   Granted   03764596.7   15-Jul-2003   1543020   13-Apr-2011

AVSI0023

  FR   Granted   03764596.7   15-Jul-2003   1543020   13-Apr-2011

AVSI0023

  GB   Granted   03764596.7   15-Jul-2003   1543020   13-Apr-2011

AVSI0023

  US   Granted   10/619939   15-Jul-2003   7316925   08-Jan-2008

AVSI0043

  US   Granted   11339894   26-Jan-2006   7846720   07-Dec-2010

AVSI0043

  US   Published   12948061   17-Nov-2010    

 

2. LEADER SEQUENCES

UPVG0044 - HIGHLY EXPRESSIBLE GENES (IgE)

 

Inovio Ref

 

Country

 

Status

 

Serial Number

 

Filing Date

 

Patent No.

 

Issue Date

UPVG0044

  DE   Granted   01979579.8   04-Oct-2001   1328653   01-Aug-2012

UPVG0044

  EP   Granted   01979579.8   04-Oct-2001   1328653   01-Aug-2012

 

- 82 -

--------------------------------------------------------------------------------

UPVG0044

  FR   Granted   01979579.8   04-Oct-2001   1328653   01-Aug-2012

UPVG0044

  GB   Granted   01979579.8   04-Oct-2001   1328653   01-Aug-2012

UPVG0044

  IE   Granted   01979579.8   04-Oct-2001   1328653   01-Aug-2012

UPVG0044

  JP   Granted   2002-532657   04-Oct-2001   4472250   12-Mar-2010

UPVG0044

  US   Granted   09971806   04-Oct-2001   6733994   11-May-2004

UPVG0044

  WO   Published   PCT/US01/31451   04-Oct-2001    

 

3. PROMOTERS

AVSI-0012 - METHOD FOR THE IDENTIFICATION OF SYNTHETIC CELL-OR TISSUE- SPECIFIC
TRANSCRIPTIONAL REGULATORY REGIONS

AVSI-0027 - SYNTHETIC MUSCLE PROMOTERS WITH ACTIVITIES EXCEEDING NATURALLY
OCCURRING REGULATORY SEQUENCES IN CARDIAC CELLS

VAL1009 - METHOD FOR THE IDENTIFICATION OF SYNTHETIC CELL-OR TISSUE-SPECIFIC
TRANSCRIPTIONAL REGULATORY REGIONS C5/C12

 

Inovio Ref

 

Country

 

Status

 

Serial Number

 

Filing Date

 

Patent No.

 

Issue Date

AVSI0012

  US   Granted   09/115407   14-Jul-1998   6,410,228   25-Jun-2002

AVSI0027

  AU   Granted   2003295366   30-Oct-2003   2003295366   08-Mar-2012

AVSI0027

  CA   Published   2504593   30-Oct-2003    

AVSI0027

  TW   Granted   92130336   30-Oct-2003   290174   21-Nov-2007

VAL1009

  US   Granted   11/080827   14-Mar-2005   7960536   14-Jun-2011

 

- 83 -

--------------------------------------------------------------------------------

3. Patent rights to ProducTs

 

1. Hepatitis B

hepb - upvg0037 - NUCLEIC ACID MOLECULE ENCODING HEPATITIS B VIRUS CORE PROTEIN
AND VACCINE COMPRISING THE SAME

 

Inovio Ref

 

Country

 

Status

 

Serial Number

 

Filing Date

 

Patent No.

 

Issue Date

UPVG0037

  WO   Published   PCT/US12/24905   13-Feb-2012    

UPVG0037

  US   Expired   61442162   11-Feb-2011    

UPVG0037

  US   Published   13622965   09-Sep-2012    

UPVG0037

  US   Pending   13984771   09-Aug-2013    

UPVG0037

  AU   Filed   *   13-Feb-2012    

UPVG0037

  BR   Filed   *   13-Feb-2012    

UPVG0037

  CA   Filed   *   13-Feb-2012    

UPVG0037

  EA   Filed   *   13-Feb-2012    

UPVG0037

  EP   Filed   *   13-Feb-2012    

UPVG0037

  IN   Filed   *   13-Feb-2012    

UPVG0037

  JP   Filed   *   13-Feb-2012    

UPVG0037

  KR   Filed   *   13-Feb-2012    

UPVG0037

  MX   Filed   *   13-Feb-2012    

UPVG0037

  ZA   Filed   *   13-Feb-2012    

* -Cases filed during Aug.–Sept. 2013

 

- 84 -

--------------------------------------------------------------------------------

2. PROSTATE CANCER

prostate - upvg0036 - CONSENSUS PROSTATE ANTIGENS, NUCLEIC ACID MOLECULE
ENCODING THE SAME AND VACCINE AND USES COMPRISING THE SAME

 

Inovio Ref

 

Country

 

Status

 

Serial Number

 

Filing Date

 

Patent No.

 

Issue Date

UPVG0036

  AU   Filed     14-Nov-2011    

UPVG0036

  BR   Pending   BR11 2013 011705.2   14-Nov-2011    

UPVG0036

  CA   Pending   2720277   14-Nov-2011    

UPVG0036

  CN   Filed     14-Nov-2011    

UPVG0036

  EA   Pending   201390689   14-Nov-2011    

UPVG0036

  EP   Pending   11839215.8   14-Nov-2011    

UPVG0036

  IN   Pending   4088/KOLNP/2013   14-Nov-2011    

UPVG0036

  JP   Pending   100078282   14-Nov-2011    

UPVG0036

  KR   Pending   10-2013-7014954   14-Nov-2011    

UPVG0036

  MX   Pending   MX/a/2013/005195   14-Nov-2011    

UPVG0036

  US   Expired   61413176   12-Nov-2010    

UPVG0036

  US   Expired   61417817   29-Nov-2010    

UPVG0036

  US   Pending   13883978   29-Jul-2013    

UPVG0036

  WO   Reportable   PCT/US11/60592   14-Nov-2011    

UPVG0036

  ZA   Pending   201303390   14-Nov-2011    

 

- 85 -

--------------------------------------------------------------------------------

August 9. 2013

Appendix 1.84

Excluded Patent Rights

Cabilly Patent Rights, which means (a) U.S. Patent No. 4,816,567, issued
March 28, 1989, and any and all patents issuing from divisionals, continuations,
or continuations-in part of any application from which U.S. Patent No. 4,816,567
claims priority, as well as reissues, reexaminations, extensions, and foreign
patent counterparts, including inventors certificates, of any of the foregoing,
and including any related supplemental protection certificates; and (b) U.S.
Patent No. 6,331,415, issued December 18, 2001, and any and all patents issuing
from divisionals, continuations, or continuations-in-part of any application
from which U.S. Patent No. 6,331,415 claims priority, as well as reissues,
reexaminations, extensions, and foreign patent counterparts, including inventors
certificates, of any of the foregoing, and including any related supplemental
protection certificates.

Itakura/Riggs Patent Rights, which means any of the U.S. patents listed below
and any and all patents issuing from divisionals, continuations or
continuations-in-part, and any reissues, reexaminations or extensions, of these
patents or of any application from which these U.S. patents claim priority, as
well as foreign counterparts, including inventors certificates, of the
foregoing, and including any related supplemental protection certificates:

U.S. Patent No. 4,356,270

U.S. Patent No. 4,366,246

U.S. Patent No. 4,425,437

U.S. Patent No. 4,431,739

--------------------------------------------------------------------------------

U.S. Patent No. 4,563,424

U.S. Patent No. 4,571,421

U.S. Patent No. 4,704,362

U.S. Patent No. 4,812,554

U.S. Patent No. 5,221,619

U.S. Patent No. 5,420,020

U.S. Patent No. 5,583,013

Capon/Lasky Patent Rights, which means any of the U.S. patents/patent
application listed below and any and all patents issuing from divisionals,
continuations or continuations-in-part, and any reissues, reexaminations or
extensions, of these patents or of any application from which these U.S. patents
claim priority, as well as foreign counterparts, including inventors
certificates, of the foregoing, and including any related supplemental
protection certificates:

U.S. Patent No. 5,428,130

U.S. Patent No. 5,514,582

U.S. Patent No. 6,406,697

Presta Patents, which means the following U.S. patent and any and all
divisionals, continuations, continuations-in-part of any application from which
these U.S patents claim priority, including reissues, reexaminations or
extensions of these patents and foreign counterparts and supplementary
protection certificates of the foregoing:

U.S. Patent No. 6,737,056

 

- 87 -

--------------------------------------------------------------------------------

Appendix 7.7

Royalty Report Template

(for illustrative purposes only - subject to change)

 

LOGO [g596693ex10_1pg088.jpg]

--------------------------------------------------------------------------------

Appendix 14.3

Form of Press Release

 

Media Release    LOGO [g596693ex10_1pg089.jpg]

Basel, Switzerland and Blue Bell, PA, USA - 10 September 2013

Roche and Inovio Pharmaceuticals partner on Inovio’s prostate cancer and
hepatitis B immunotherapy products

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Inovio Pharmaceuticals, Inc. (NYSE MKT:
INO) announced today that they have entered into an exclusive worldwide license
agreement to research, develop and commercialize Inovio’s highly-optimized,
multi-antigen DNA immunotherapies targeting prostate cancer and hepatitis B. The
licensed compounds are currently in preclinical development and have generated
robust T-cell responses in animal models.

Roche acquired an exclusive license for Inovio’s DNA-based vaccines INO-5150
(targeting prostate cancer) and INO-1800 (targeting hepatitis B) as well as the
use of Inovio’s CELLECTRA® electroporation technology for delivery of the
vaccines. Roche also obtained an option to license additional vaccine
opportunities in connection with a collaborative research program in oncology.
Roche and Inovio will collaborate to further develop INO-5150 and INO-1800.

Under the terms of the agreement, Roche will make an upfront payment of USD $10
million to Inovio. Roche will also provide preclinical R&D support and payments
for near-term regulatory milestones as well as payments upon reaching certain
development and commercial milestones potentially up to USD $412.5 million.
Additional development milestone payments could also be made to Inovio if Roche
pursues other indications with INO-5150 or INO-1800. In addition, Inovio is
entitled to receive up to double-digit tiered royalties on product sales.

--------------------------------------------------------------------------------

Commenting on the deal, Hy Levitsky, Head of Cancer Immunology Experimental
Medicine at Roche, said: “At Roche we are always interested in finding
first-in-class and best-in-class therapies that may become the next generation
treatments for patients with different types of cancer. INO-5150 will allow
promising combination opportunities with the Roche portfolio, particularly with
our emerging cancer immunotherapy molecules.” Janet Hammond, Head of Infectious
Diseases Discovery & Translational Area at Roche, added: “We are very excited to
have this potentially very important and novel mechanism of action as part of
our portfolio as we seek to address the significant unmet medical need in
chronic hepatitis B infection.”

“This partnership represents an important milestone in Inovio’s growth and
maturing product portfolio. Roche brings to our immunotherapy candidates its
leadership position and track record for developing and marketing innovative
first-in-class therapies,” said Dr. J. Joseph Kim, Inovio’s President and CEO.
“Collaborating with the world’s preeminent oncology development partner allows
us to rapidly advance two of our promising near-clinical stage immunotherapy
products from our product pipeline as we continue development of our phase II
lead product, VGX-3100, for treatment of HPV-related cancers and dysplasia.”

- ### -

About INO-5150 for Prostate Cancer

Inovio’s dual-antigen synthetic DNA vaccine (INO-5150) targets prostate-specific
membrane antigen (PSMA) and prostate-specific antigen (PSA). A study in monkeys
showed that vaccination with INO-5150 generated strong and robust T-cell immune
responses that were the highest generated by a PSA-based immunotherapy in animal
studies and were similar to the immune responses generated by VGX-3100, Inovio’s
phase II-stage therapeutic HPV vaccine that generated best-in-class T-cell
responses in a phase I study.

Inovio’s SynCon® DNA vaccine for prostate cancer was designed with PSA and PSMA
synthetic consensus immunogens based on human and macaque sequences, resulting
in amino acid sequences that differ slightly from the native human protein. In
humans, this novel approach is utilized to help the body’s immune system
recognize cancerous cells created in the body as ‘foreign’, overcoming the
body’s self-tolerance of these cells and mounting an immune response to clear
them.

 

- 90 -

--------------------------------------------------------------------------------

About INO-1800 for Hepatitis B

Inovio has reported preclinical data showing its hepatitis B vaccine (INO-1800)
generated strong T-cell and antibody responses that led to the elimination of
targeted liver cells in mice. These results indicate this DNA vaccine’s
potential to treat hepatitis B infection and prevent further development of the
infection into liver cancer in humans.

In a preclinical study, researchers found the vaccine-specific T-cells exhibited
a killing function, and could migrate to and stay in the liver and cause
clearance of target cells without evidence of liver injury. This was the first
study to provide evidence that intramuscular immunization can induce killer
T-cells that can migrate to the liver and eliminate target cells.

To provide worldwide rights to Roche, Inovio has re-acquired its hepatitis B,
Asian-country rights from Inovio’s international affiliate.

Disease Background

Prostate Cancer

Prostate cancer is the second most frequently diagnosed cancer of men. Nearly
three-quarters of the registered cases occur in developed countries. Accounting
for nearly 300,000 deaths each year, prostate cancer is the sixth leading cause
of death from cancer in men. The development of a new treatment for prostate
cancer would be a significant medical advancement given that present treatment
options (surgery, radiation and hormone deprivation), while somewhat effective,
all carry deleterious side effects and are often not a long-term cure.

Hepatitis B and Liver Cancer

Hepatitis B is a disease characterized by inflammation of the liver. The virus
is extremely infectious - 100 times more so than HIV - and 400 million people
are chronically infected worldwide. Hepatitis B contributes to an estimated
1 million deaths worldwide each year.

Liver cancer is the third most common cancer and the most deadly, killing most
patients within five years of diagnosis. About 600,000 new cases arise each
year. One of the major causes and risk factors for liver cancer is infection by
hepatitis B.

 

- 91 -

--------------------------------------------------------------------------------

About Inovio Pharmaceuticals, Inc.

Inovio is revolutionizing vaccines to prevent and treat today’s cancers and
challenging infectious diseases. Its SynCon® vaccines, in combination with its
proprietary electroporation delivery, are generating best-in-class immune
responses, with therapeutic T-cell responses exceeding other technologies in
terms of magnitude, breadth, and response rate. Human data to date have shown a
favorable safety profile. Inovio’s lead vaccine, a therapeutic against
HPV-caused pre-cancers and cancers, is in phase II. Other phase I and
preclinical programs target prostate, breast, and lung cancers as well as HIV,
influenza, malaria and hepatitis C virus. Partners and collaborators include the
University of Pennsylvania, Merck, NIH, HIV Vaccines Trial Network, National
Cancer Institute, U.S. Military HIV Research Program, University of Southampton,
US Dept. of Homeland Security, University of Manitoba and PATH Malaria Vaccine
Initiative. More information is available at www.inovio.com.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused
healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is
the world’s largest biotech company, with truly differentiated medicines in
oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche
is also the world leader in in vitro diagnostics and tissue-based cancer
diagnostics, and a frontrunner in diabetes management. Roche’s personalised
healthcare strategy aims at providing medicines and diagnostic tools that enable
tangible improvements in the health, quality of life and survival of patients.
In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion
Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs.
Genentech, in the United States, is a wholly owned member of the Roche Group.
Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more
information, please visit www.roche.com.

This press release contains certain forward-looking statements relating to
Inovio’s partnership with Roche related to Inovio’s Hepatitis B and prostate
cancer immunotherapeutic products, in addition to Inovio’s business, including
our plans to develop other electroporation-based drug and gene delivery
technologies and DNA vaccines and our capital resources. Actual events or
results may differ from the expectations set forth herein, including realization
of any and all projected development or sales milestone payments, as a result of
a number of factors, including Roche’s change in business resulting in the
amendment or termination of the Agreement, uncertainties inherent in
pre-clinical

 

- 92 -

--------------------------------------------------------------------------------

studies, clinical trials and product development programs (including, but not
limited to, the fact that pre-clinical and clinical results referenced in this
release may not be indicative of results achievable in other trials or for other
indications, that the studies or trials may not be successful or achieve the
results desired, that pre-clinical studies and clinical trials may not commence
or be completed in the time periods anticipated, that results from one study may
not necessarily be reflected or supported by the results of other similar
studies and that results from an animal study may not be indicative of results
achievable in human studies), the availability of funding to support continuing
research and studies in an effort to prove safety and efficacy of
electroporation technology as a delivery mechanism or develop viable DNA
vaccines, the adequacy of our capital resources, the availability or potential
availability of alternative therapies or treatments for the conditions targeted
by the company or its collaborators, including alternatives that may be more
efficacious or cost-effective than any therapy or treatment that the company and
its collaborators hope to develop, evaluation of potential opportunities, issues
involving product liability, issues involving patents and whether they or
licenses to them will provide the company with meaningful protection from others
using the covered technologies, whether such proprietary rights are enforceable
or defensible or infringe or allegedly infringe on rights of others or can
withstand claims of invalidity and whether the company can finance or devote
other significant resources that may be necessary to prosecute, protect or
defend them, the level of corporate expenditures, assessments of the company’s
technology by potential corporate or other partners or collaborators, capital
market conditions, the impact of government healthcare proposals and other
factors set forth in our Annual Report on Form 10-K for the year ended
December 31, 2012, our Form 10-Q for the quarter ended June 30, 2013, and other
regulatory filings from time to time. There can be no assurance that any product
in Inovio’s pipeline will be successfully developed or manufactured, that final
results of clinical studies will be supportive of regulatory approvals required
to market licensed products, or that any of the forward-looking information
provided herein will be proven accurate.

For further information:

Roche Partnering

Emilie Vincent, Head of Roche Partnering Communications,
emilie.vincent@roche.com

Inovio

Investors: Bernie Hertel, Inovio Pharmaceuticals, +1858-410-3101,
bhertel@inovio.com

Media: Jeff Richardson, Inovio Pharmaceuticals, +1 267-440-4211,
jrichardson@inovio.com

 

- 93 -