Collaboration, Option and License Agreement

EX-10.1 2 d596693dex101.htm EX-10.1 EX-10.1

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

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	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

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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

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	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

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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.

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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

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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

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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.

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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.

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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

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.

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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.

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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.

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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.

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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.

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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.

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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:

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);

governmental price reductions and government mandated rebates;

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

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

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.

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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

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

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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.

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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

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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.

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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

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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:

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

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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

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.

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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

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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.

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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.

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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.

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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.

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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 ‘’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’’’’’’’ ‘’’’’’’’’’’’’.

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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.

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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

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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

‘’’’’’’’ ‘’’’’ ‘’’’’’

‘’’’’’’’ ‘’’’ ‘’’’’’’’’’’

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

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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 10^th 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

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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

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		‘’’’’’ ‘’’’ ‘’’’’

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

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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

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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.

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.

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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.

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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.

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

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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.

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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.

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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.

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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

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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.

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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

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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

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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

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.

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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.

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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

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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.

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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.

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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.

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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.

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.

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.

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.

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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

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.

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

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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

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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

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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.

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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 ###-###-####

And:		Attn: Legal Department Facsimile No.: 267 ###-###-####

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 ###-###-####

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]

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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

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Appendix 1.54

Inovio Background Patent Rights

INOVIO PATENT/IP SCHEDULE

1	PATENT RIGHTS TO DELIVERY DEVICES

A.	Electroporation

1)	CELLECTRA^®

2)	SKIN/MUSCLE

SKIN

MUSCLE

5)	ONCOLOGY - TUMORS

OTHER

2	PATENT RIGHTS TO ENABLING TECHNOLOGIES

A.	Vaccine Additives

ADJUVANTS

IL-15

IL-15 R-ALPHA

CTACK, MEK, TECK

RANTES

IL-28

IL-12

FORMULATIONS

PLG - LIPID ADDITIVES

PLG - LYOPHILIZATION FORMULA

B.	Functional DNA

PLASMIDS

2.	LEADER SEQUENCES

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

Granted

2009251157

23-Dec-2009

2009251157

09-Aug-2012

AVSI0010

Published

2477870

06-Mar-2003

AVSI0010

Published

03717937.1

06-Mar-2003

AVSI0010

Granted

PA/A/2004/008670

06-Mar-2003

263479

06-Jan-2009

AVSI0010

Granted

200405195-9

06-Mar-2003

106747

29-Sep-2006

AVSI0010

Granted

92104867

06-Mar-2003

239855

21-Sep-2005

AVSI0010

Granted

10/360768

07-Mar-2002

7245963

17-Jul-2007

AVSI0010

Granted

11/495021

28-Jul-2006

7664545

16-Feb-2010

AVSI0010

Reportable

PCT/US03/06833

06-Mar-2003

AVSI0010 P1

Allowed

2578847

03-Sep-2004

AVSI0010 P1

Published

04788598.3

03-Sep-2004

AVSI0010 P1

Granted

93127152

08-Sep-2004

246930

11-Jan-2006

AVSI0010 P1

Granted

10/657725

08-Sep-2003

8209006

26-Jun-2012

AVSI0010 P1

Reportable

PCT/US04/28998

03-Sep-2004

AVSI0048

Granted

2007313203

17-Oct-2007

2007313203

29-Nov-2012

AVSI0048

Published

2666501

17-Oct-2007

AVSI0048

Published

200780046652.7

17-Oct-2007

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AVSI0048

Published

07839621.5

17-Oct-2007

AVSI0048

Published

11184546.7

10-Oct-2011

AVSI0048

Published

09111461.8

08-Dec-2009

AVSI0048

Pending

2366/DELNP/2009

17-Oct-2007

AVSI0048

Published

2009-533358

15-Jun-2009

AVSI0048

Pending

2009 ###-###-####

17-Oct-2007

AVSI0048

Pending

200902629-5

17-Oct-2007

AVSI0048

Granted

201107493-7

12-Oct-2011

175627

15-Apr-2013

AVSI0048

Published

11/874072

17-Oct-2007

AVSI0048

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

Granted

49883/99

13-Jul-1999

770092

27-May-2004

GTI-1130

Granted

2337652

13-Jul-1999

2337652

26-Mar-2013

GTI-1130

Published

99933937.7

13-Jul-1999

GTI-1130

Published

11180420.9

07-Sep-2011

GTI-1130

Published

11180419.1

07-Sep-2011

GTI-1130

Granted

09/352809

13-Jul-1999

6697669

24-Feb-2004

GTI-1130

Granted

10/165657

07-Jun-2002

6678556

13-Jan-2004

GTI-1130

Granted

10/756946

13-Jan-2004

7570992

04-Aug-2009

GTI-1130

Granted

09/625825

26-Jul-2000

6654636

25-Nov-2003

GTI-1130

Granted

10/233007

30-Aug-2002

6972013

06-Dec-2005

GTI-1130

Granted

11/291459

30-Nov-2005

7922709

12-Apr-2011

GTI-2010

Published

2009205643

16-Jan-2009

GTI-2010

Published

2710408

16-Jan-2009

GTI-2010

Published

200980103021.3

16-Jan-2009

GTI-2010

Published

09702445.9

16-Jan-2009

GTI-2010

Published

11106149.4

15-Jun-2011

- 64 -

GTI-2010

Published

4726/DELNP/2010

30-Jun-2010

GTI-2010

Published

2010-543139

16-Jan-2009

GTI-2010

Pending

10 ###-###-####

16-Aug-2010

GTI-2010

Published

12836163

14-Jul-2010

GTI-2010

Published

PCT/US2009/000273

16-Jan-2009

VGX0118

Published

2011223768

01-Mar-2011

VGX0118

Published

2789733

01-Mar-2011

VGX0118

Published

11751203.8

01-Mar-2011

VGX0118

Pending

10 ###-###-####

01-Mar-2011

VGX0118

Expired

61309423

01-Mar-2010

VGX0118

Expired

61309860

02-Mar-2010

VGX0118

Published

13581700

29-Aug-2012

VGX0118

Published

PCT/US2011/026688

01-Mar-2011

SPHERG1

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

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

Granted

99966432.9

17-Dec-1999

1140283

08-Mar-2006

- 65 -

GTI-1530

Granted

14354/95

13-Dec-1994

691237

27-Aug-1998

GTI-1530

Granted

68821/98

02-Apr-1998

741399

14-Mar-2002

GTI-1530

Granted

21969/00

17-Dec-1999

763535

06-Nov-2003

GTI-1530

Granted

2185024

13-Dec-1994

2185024

08-May-2001

GTI-1530

Granted

2311474

02-Apr-1998

2311474

02-Oct-2012

GTI-1530

Granted

99966432.9

17-Dec-1999

1140283

08-Mar-2006

GTI-1530

Granted

95905926.2

13-Dec-1994

P69426210.2

25-Oct-2000

GTI-1530

Granted

98914475.3

02-Apr-1998

69806794.0

24-Jul-2002

GTI-1530

Granted

99966432.9

17-Dec-1999

1140283

08-Mar-2006

GTI-1530

Granted

95905926.2

13-Dec-1994

0751802

25-Oct-2000

GTI-1530

Granted

98914475.3

02-Apr-1998

1028777

24-Jul-2002

GTI-1530

Granted

99966432.9

17-Dec-1999

1140283

08-Mar-2006

GTI-1530

Granted

99966432.9

17-Dec-1999

1140283

08-Mar-2006

GTI-1530

Granted

95905926.2

13-Dec-1994

0751802

25-Oct-2000

GTI-1530

Granted

98914475.3

02-Apr-1998

1028777

24-Jul-2002

GTI-1530

Granted

99966432.9

17-Dec-1999

1140283

08-Mar-2006

GTI-1530

Granted

95905926.2

13-Dec-1994

0751802

25-Oct-2000

GTI-1530

Granted

98914475.3

02-Apr-1998

1028777

24-Jul-2002

GTI-1530

Granted

99966432.9

17-Dec-1999

1140283

08-Mar-2006

GTI-1530

Granted

95905926.2

13-Dec-1994

0751802

25-Oct-2000

GTI-1530

Granted

99966432.9

17-Dec-1999

1140283

08-Mar-2006

GTI-1530

Granted

525651/95

13-Dec-1994

3554935

21-May-2004

- 66 -

GTI-1530

Granted

99966432.9

17-Dec-1999

1140283

08-Mar-2006

GTI-1530

Granted

87106879

05-May-1998

NI-108036

01-Sep-1999

GTI-1530

Granted

08/310647

22-Sep-1994

5464386

07-Nov-1995

GTI-1530

Granted

08/552200

02-Nov-1995

5688233

18-Nov-1997

GTI-1530

Granted

08/964436

04-Nov-1997

6009345

28-Dec-1999

GTI-1530

Granted

09/213782

17-Dec-1998

5968006

19-Oct-1999

GTI-3010

Published

2756276

16-Apr-2010

GTI-3010

Published

10765277.8

16-Apr-2010

GTI-3010

Pending

10 ###-###-####

16-Apr-2010

GTI-3010

Published

13263802

10-Oct-2011

GTI-3010

Published

PCT/US10/31431

16-Apr-2010

VGX0117

Published

2011223753

01-Mar-2011

VGX0117

Pending

11 2012 0218050

01-Mar-2011

VGX0117

Published

2789736

01-Mar-2011

VGX0117

Published

201180011473.6

01-Mar-2011

VGX0117

Pending

201201203

01-Mar-2011

VGX0117

Published

11751208.7

01-Mar-2011

VGX0117

Pending

201180011473.6

01-Mar-2011

VGX0117

Pending

7555/DELNP/2012

01-Mar-2011

VGX0117

Published

2012556176

01-Mar-2011

VGX0117

Pending

10 ###-###-####

01-Mar-2011

VGX0117

Pending

MX/a/2012/009986

01-Mar-2011

- 67 -

VGX0117

Expired

61309422

01-Mar-2010

VGX0117

Published

13581702

05-Oct-2012

VGX0117

Pending

201206478

01-Mar-2011

VGX0117

Published

PCT/US11/26701

01-Mar-2011

VGX0123

Expired

61402712

28-Jun-2011

VGX0123

Published

PCT/US12/44539

28-Jun-2012

USF-A3

Published

2478614

13-Mar-2002

USF-A3

Granted

10605126

10-Sep-2003

7769440

03-Aug-2010

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

Granted

41771/00

23-Mar-2000

778736

14-Apr-2005

GTI-1370

Published

00921451.1

23-Mar-2000

GTI-1370

Granted

89105497

11-Apr-2000

NI-153798

06-Aug-2002

GTI-1370

Granted

10/215963

08-Aug-2002

7054685

30-May-2006

GTI-1370

Granted

09/535683

23-Mar-2000

6678558

13-Jan-2004

- 68 -

GTI-5000

Granted

98909691.2

03-Apr-1998

1023107

30-Aug-2006

GTI-5000

Granted

69906/98

03-Apr-1998

733628

30-Aug-2001

GTI-5000

Granted

98909691.2

03-Apr-1998

1023107

30-Aug-2006

GTI-5000

Granted

2285056

03-Apr-1998

2285056

14-Dec-2004

GTI-5000

Granted

98909691.2

03-Apr-1998

1023107

30-Aug-2006

GTI-5000

Granted

98803980.X

03-Apr-1998

ZL98803980

24-Apr-2006

GTI-5000

Granted

98909691.2

03-Apr-1998

69835761.2

30-Aug-2006

GTI-5000

Granted

98909691.2

03-Apr-1998

1023107

30-Aug-2006

GTI-5000

Granted

199900882

03-Apr-1998

002087

24-Dec-2001

GTI-5000

Granted

98909691.2

03-Apr-1998

1023107

30-Aug-2006

GTI-5000

Granted

98909691.2

03-Apr-1998

1023107

30-Aug-2006

GTI-5000

Granted

98909691.2

03-Apr-1998

1023107

30-Aug-2006

GTI-5000

Granted

98909691.2

03-Apr-1998

1023107

30-Aug-2006

GTI-5000

Granted

98909691.2

03-Apr-1998

1023107

30-Aug-2006

GTI-5000

Granted

98909691.2

03-Apr-1998

1023107

30-Aug-2006

GTI-5000

Granted

1999 ###-###-####

03-Apr-1998

427786

07-Apr-2004

GTI-5000

Granted

199900882

03-Apr-1998

2087

24-Dec-2001

GTI-5000

Granted

98909691.2

03-Apr-1998

1023107

30-Aug-2006

GTI-5000

Granted

999026

03-Apr-1998

253159

09-Jan-2008

GTI-5000

Granted

98909691.2

03-Apr-1998

1023107

30-Aug-2006

GTI-5000

Granted

19994820

03-Apr-1998

327806

28-Sep-2009

GTI-5000

Granted

337853

03-Apr-1998

337853

08-Jul-2002

GTI-5000

Granted

199900882

03-Apr-1998

2087

24-Dec-2001

- 69 -

GTI-5000

Granted

98909691.2

03-Apr-1998

1023107

30-Aug-2006

GTI-5000

Granted

09/565140

05-May-2000

6261281

17-Jul-2001

GTI-5000

Granted

09/055084

03-Apr-1998

6110161

29-Aug-2000

GTI-5000

Granted

10/141561

07-May-2002

6610044

26-Aug-2003

GTI-5000

Granted

10/620271

14-Jul-2003

6958060

25-Oct-2005

GTI-5000

Granted

12/070233

15-Feb-2008

7931640

26-Apr-2011

GTI-5000

Reportable

IB9800487

03-Apr-1998

GTI-5000

Reportable

2001GB01970

04-May-2001

GTI-5001

Granted

2009202678

01-Jul-2009

2009202678

29-Nov-2012

GTI-5001

Published

2491000

04-Jul-2003

GTI-5001

Granted

03820724.9

04-Jul-2003

03820724.9

28-Apr-2010

GTI-5001

Granted

200401558

04-Jul-2003

009203

28-Dec-2007

GTI-5001

Allowed

03762794.0

04-Jul-2003

GTI-5001

Published

05108751.7

04-Jul-2003

GTI-5001

Pending

4137/DELNP/2004

04-Jul-2003

GTI-5001

Granted

2004-518966

04-Jul-2003

4461012

19-Feb-2010

GTI-5001

Published

2009-279074

09-Dec-2009

GTI-5001

Granted

PA/A/2005/000155

04-Jul-2003

277428

21-Jul-2010

GTI-5001

Granted

562306

04-Jul-2003

562306

08-Oct-2009

GTI-5001

Granted

566578

04-Jul-2003

566578

12-Nov-2009

GTI-5001

Granted

200401558

04-Jul-2003

9203

28-Dec-2007

GTI-5001

Granted

10/612304

03-Jul-2003

7328064

05-Feb-2008

- 70 -

GTI-5001

Published

11/985825

16-Nov-2007

GTI-5001

Reportable

PCT/GB2003/002887

04-Jul-2003

GTI-5001

Granted

2005/0058

04-Jul-2003

2005/0058

29-Mar-2006

GTI-7001

Granted

2007215263

09-Feb-2007

2007215263

20-Oct-2011

GTI-7001

Published

2635437

09-Feb-2007

GTI-7001

Pending

2686855

16-May-2008

GTI-7001

Granted

200780002313.9

09-Feb-2007

200780002313.9

25-Dec-2012

GTI-7001

Published

07750450.4

09-Feb-2007

GTI-7001

Published

08767759.7

20-Nov-2009

GTI-7001

Pending

6100/DELNP/2008

11-Jul-2008

GTI-7001

Granted

2008-554405

09-Feb-2007

5059786

10-Aug-2012

GTI-7001

Published

7019463/2008

09-Feb-2007

GTI-7001

Granted

MX/a/2008/008981

09-Feb-2007

311676

24-Jul-2013

GTI-7001

Pending

20083811

09-Feb-2007

GTI-7001

Published

11/704591

09-Feb-2007

GTI-7001

Reportable

PCT/US2007/003615

09-Feb-2007

GTI-7001

Reportable

PCT/US2008/006311

16-May-2008

SPHERG2

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

Granted

10677214

01-Oct-2003

7181271

20-Feb-2007

GTI-1160

Granted

2216131

10-Apr-1995

2216131

05-Feb-2002

GTI-1160

Granted

2218255

22-May-1996

2218255

20-Nov-2001

GTI-1160

Granted

96194608.3

22-May-1996

ZL96194608.3

26-May-2004

GTI-1160

Granted

02008920.7

10-Apr-1995

1240917

23-Jun-2004

GTI-1160

Granted

96916550.5

22-May-1996

69604509.5

29-Sep-1999

GTI-1160

Granted

02008920.7

10-Apr-1995

1240917

23-Jun-2004

GTI-1160

Granted

96916550.5

22-May-1996

0874663

29-Sep-1999

GTI-1160

Granted

02008920.7

10-Apr-1995

1240917

23-Jun-2004

GTI-1160

Granted

96916550.5

22-May-1996

0874663

29-Sep-1999

GTI-1160

Granted

02008920.7

10-Apr-1995

1240917

23-Jun-2004

GTI-1160

Granted

96916550.5

22-May-1996

0874663

29-Sep-1999

GTI-1160

Granted

530968/96

10-Apr-1995

3338880

16-Aug-2002

GTI-1160

Granted

706014/97

10-Apr-1995

247255

10-Dec-1999

GTI-1160

Granted

708424/97

22-May-1996

260238

04-Apr-2000

GTI-1160

Granted

PA/A/1997/006929

10-Apr-1995

218786

21-Jan-2004

- 72 -

GTI-1160

Granted

PA/A/1997/008316

22-May-1996

248023

13-Aug-2007

GTI-1160

Granted

08/467566

06-Jun-1995

5702359

30-Dec-1997

GTI-1160

Granted

09/427151

25-Oct-1999

6451002

17-Sep-2002

GTI-1160

Granted

10/053861

17-Jan-2002

6567694

20-May-2003

GTI-1160

Granted

09/551327

18-Apr-2000

6418341

09-Jul-2002

GTI-1160

Granted

90/005590

15-Dec-1999

5702359C1

28-Mar-2006

GTI-1160

Granted

08/930168

10-Apr-1995

5810762

22-Sep-1998

GTI-1160

Granted

08/042039

01-Apr-1993

5439440

08-Aug-1995

GTI-1160

Granted

08/537265

29-Sep-1995

5993434

30-Nov-1999

GTI-1160

Granted

10/177560

21-Jun-2002

6569149

27-May-2003

GTI-1160

Granted

10/213514

06-Aug-2002

6763264

13-Jul-2004

GTI-1200

Granted

P990105331

21-Oct-1999

AR020932B1

30-May-2006

GTI-1200

Granted

86823/98

31-Jul-1998

734343

27-Sep-2001

GTI-1200

Granted

17074/00

21-Oct-1999

767814

11-Mar-2004

GTI-1200

Granted

2268026

31-Jul-1998

2268026

29-Jul-2003

GTI-1200

Granted

98801461.0

31-Jul-1998

98801461.0

07-Sep-2005

GTI-1200

Granted

200510084733.9

31-Jul-1998

1768873

28-Jan-2011

GTI-1200

Granted

98938256.9

31-Jul-1998

999867

08-Sep-2010

GTI-1200

Granted

98938256.9

31-Jul-1998

999867

08-Sep-2010

GTI-1200

Granted

98938256.9

31-Jul-1998

999867

08-Sep-2010

GTI-1200

Granted

98938256.9

31-Jul-1998

999867

08-Sep-2010

GTI-1200

Granted

00106147.9

31-Jul-1998

1027049

28-Apr-2006

- 73 -

GTI-1200

Granted

2002-57679

31-Jul-1998

4180285

05-Sep-2008

GTI-1200

Granted

10 ###-###-####

31-Jul-1998

756252

31-Aug-2007

GTI-1200

Granted

09/177678

22-Oct-1998

6241701

05-Jun-2001

GTI-1200

Granted

09/861016

18-May-2001

6516223

04-Feb-2003

GTI-1200

Granted

09/189062

09-Nov-1998

6233482

15-May-2001

GTI-1200

Granted

09/189360

09-Nov-1998

6181964

30-Jan-2001

GTI-1200

Granted

09/189070

09-Nov-1998

6068650

30-May-2000

GTI-1200

Granted

08/905240

01-Aug-1997

6055453

25-Apr-2000

GTI-1200

Granted

09/900601

05-Jul-2001

7412284

12-Aug-2008

GTI-1200

Granted

09/227417

08-Jan-1999

6216034

10-Apr-2001

GTI-1200

Granted

09/227416

08-Jan-1999

6014584

11-Jan-2000

GTI-1200

Granted

98/7596

21-Aug-1998

98/7596

31-Aug-1999

GTI-1230

Granted

09969367

01-Oct-2001

6865416

08-Mar-2005

GTI-1230

Granted

09307216

07-May-1999

6347247

12-Feb-2002

GTI-1250

Granted

09/206635

07-Dec-1998

6120493

19-Sep-2000

GTI-1250

Granted

09/014291

27-Jan-1998

6009347

28-Dec-1999

GTI-1250

Granted

09/234770

21-Jan-1999

6208893

27-Mar-2001

GTI-1360

Granted

10/339708

08-Jan-2003

7171264

30-Jan-2007

GTI-1360

Granted

09/567404

08-May-2000

6520950

18-Feb-2003

- 74 -

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

Pending

2795547

28-Apr-2011

GTI-4010

Published

201180021234.9

28-Apr-2011

GTI-4010

Published

11775553.8

28-Apr-2011

GTI-4010

Pending

13108500.1

28-Apr-2011

GTI-4010

Pending

10 ###-###-####

28-Apr-2011

GTI-4010

Published

13641977

18-Oct-2012

GTI-4010

Published

PCT/US11/34277

28-Apr-2011

GTI-9000

Allowed

2007322075

16-Nov-2007

GTI-9000

Pending

2013206520

16-Nov-2007

GTI-9000

Published

2668649

16-Nov-2007

GTI-9000

Published

200780037742.X

16-Nov-2007

GTI-9000

Published

07840065.2

16-Nov-2007

GTI-9000

Published

10101823.9

22-Feb-2010

GTI-9000

Published

2009-537218

16-Nov-2007

GTI-9000

Published

7007135/2009

07-Apr-2009

GTI-9000

Published

11/985871

16-Nov-2007

GTI-9000

Reportable

PCT/US2007/24051

16-Nov-2007

- 75 -

2.	Patent rights to enabling technologies

A.	Vaccine Additives

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

Granted

2007208452

12-Jan-2007

2007208452

18-Oct-2012

UPVG0017

Published

2636867

12-Jan-2007

UPVG0017

Granted

7762574.7

12-Jan-2007

1976871

16-Nov-2011

UPVG0017

Granted

7762574.7

12-Jan-2007

1976871

16-Nov-2011

UPVG0017

Granted

7762574.7

12-Jan-2007

1976871

16-Nov-2011

UPVG0017

Granted

7762574.7

12-Jan-2007

1976871

16-Nov-2011

UPVG0017

Granted

7762574.7

12-Jan-2007

1976871

16-Nov-2011

UPVG0017

Granted

7762574.7

12-Jan-2007

1976871

16-Nov-2011

UPVG0017

Granted

7762574.7

12-Jan-2007

1976871

16-Nov-2011

UPVG0017

Pending

2971/KOLNP/2008

12-Jan-2007

UPVG0017

Allowed

2008-550435

12-Jan-2007

UPVG0017

Pending

10 ###-###-####

12-Jan-2007

- 76 -

UPVG0017

Granted

7762574.7

12-Jan-2007

1976871

16-Nov-2011

UPVG0017

Granted

7762574.7

12-Jan-2007

1976871

16-Nov-2011

UPVG0017

Granted

MX/A/2008/008928

12-Jan-2007

296941

09-Mar-2012

UPVG0017

Granted

7762574.7

12-Jan-2007

1976871

16-Nov-2011

UPVG0017

Granted

12160766

30-Mar-2009

8178660

15-May-2012

UPVG0017

Reportable

PCT/US07/000886

12-Jan-2007

UPVG0028

Pending

PCT/US10/48827

14-Sep-2010

UPVG0028

Pending

PCT/US10/48827

14-Sep-2010

UPVG0028

Published

PCT/US10/48827

14-Sep-2010

UPVG0028

Published

10816292.6

14-Sep-2010

UPVG0028

Pending

406/MUMNP/2012

14-Sep-2010

UPVG0028

Published

PCT/US10/48827

14-Sep-2010

UPVG0028

Pending

10 ###-###-####

14-Sep-2010

UPVG0028

Published

13391615

21-Feb-2012

UPVG0028

Published

PCT/US10/48827

14-Sep-2010

UPVG0018

Pending

13284824

28-Oct-2011

UPVG0018

Reportable

PCT/US05/42231

18-Nov-2005

UPVG0029

Pending

2011213559

08-Feb-2011

UPVG0029

Pending

2788902

08-Feb-2011

UPVG0029

Published

201180008582.2

08-Feb-2011

UPVG0029

Published

11740539.9

08-Feb-2011

UPVG0029

Pending

7013/DELNP/2012

08-Feb-2011

UPVG0029

Published

2012-552154

08-Feb-2011

UPVG0029

Pending

10 ###-###-####

08-Feb-2011

UPVG0029

Published

13577387

04-Ocy-2012

- 77 -

UPVG0029

Published

PCT/US11/24098

08-Feb-2011

UPVG0031

Pending

2009231598

06-Apr-2009

UPVG0031

Pending

2720168

06-Apr-2009

UPVG0031

Published

200980112452.6

06-Apr-2009

UPVG0031

Published

09726983.1

06-Apr-2009

UPVG0031

Pending

11110692.7

10-Oct-2011

UPVG0031

Published

3545/KOLNP/2010

06-Apr-2009

UPVG0031

Published

2011-503239

06-Apr-2009

UPVG0031

Pending

10 ###-###-####

06-Apr-2009

UPVG0031

Pending

12936192

01-Oct-2010

UPVG0031

Published

PCT/US2009/039648

06-Apr-2009

UPVG0041

Published

PCT/US12/69017

11-Dec-2012

UPVG0041

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

Granted

200406924-1

23-May-2003

108408

29-Dec-2006

AVSI0021 P2

Pending

10 ###-###-####

15-Jun-2010

VAL1001

Granted

08/971951

17-Nov-1997

5902802

11-May-1999

VAL1002

Granted

08/480923

07-Jun-1995

5932241

03-Aug-1999

VAL1003

Granted

08/825854

04-Apr-1997

5958894

28-Sep-1999

VAL1004

Granted

09/054769

03-Apr-1998

6235310

22-May-2001

VAL1005

Granted

09/183634

30-Oct-1998

6121457

19-Sep-2000

VAL1005

Granted

09/626268

25-Jul-2000

6245520

12-Jun-2001

VAL1006

Granted

08/184547

21-Jan-1994

5792751

11-Aug-1998

VAL1008

Granted

08/372213

13-Jan-1995

6040295

21-Mar-2000

VAL1008

Granted

08/798974

11-Feb-1997

6514947

04-Feb-2003

VAL1010

Granted

99939113.9

10-Aug-1999

1104309

03-May-2006

- 79 -

VAL1010

Granted

CA19992340416

10-Aug-1999

2340416

25-Aug-2009

VAL1010

Granted

99939113.9

10-Aug-1999

1104309

03-May-2006

VAL1010

Granted

99939113.9

10-Aug-1999

1104309

03-May-2006

VAL1010

Granted

99939113.9

10-Aug-1999

1104309

03-May-2006

VAL1010

Granted

99939113.9

10-Aug-1999

1104309

03-May-2006

VAL1010

Granted

99939113.9

10-Aug-1999

1104309

03-May-2006

VAL1010

Granted

2000-564589

10-Aug-1999

4538150

25-Jun-2010

VAL1010

Granted

99939113.9

10-Aug-1999

1104309

03-May-2006

VAL1010

Granted

09/371619

10-Aug-1999

6534483

18-Mar-2003

VAL1012

Published

2401327

02-Mar-2001

VAL1012

Granted

01918339

02-Mar-2001

1259265

01-Jun-2011

VAL1012

Granted

01918339

02-Mar-2001

1259265

01-Jun-2011

VAL1012

Granted

01918339

02-Mar-2001

1259265

01-Jun-2011

VAL1012

Granted

01918339

02-Mar-2001

1259265

01-Jun-2011

VAL1012

Granted

01918339

02-Mar-2001

1259265

01-Jun-2011

- 80 -

VAL1012

Granted

01918339

02-Mar-2001

1259265

01-Jun-2011

VAL1012

Granted

01918339

02-Mar-2001

1259265

01-Jun-2011

VAL1012

Granted

2001-564801

02-Mar-2001

5253499

17-Apr-2012

VAL1012

Granted

01918339

02-Mar-2001

1259265

01-Jun-2011

VAL1012

Granted

01918339

02-Mar-2001

1259265

01-Jun-2011

VAL1012

Granted

01918339

02-Mar-2001

1259265

01-Jun-2011

VAL1012

Granted

10/234406

03-Sep-2002

7173116

06-Feb-2007

VAL1012

Granted

11/561847

20-Nov-2006

7491537

17-Feb-2009

- 81 -

INOVIO PATENT/IP SCHEDULE

B)	Functional DNA

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

Granted

08/472809

07-Jun-1995

5925564

20-Jul-1999

AVSI0015

Granted

08/372213

13-Jan-1995

6,040,295

21-Mar-2000

AVSI0023

Granted

2003249208

15-Jul-2003

2003249208

18-Jun-2010

AVSI0023

Granted

03764596.7

15-Jul-2003

1543020

13-Apr-2011

AVSI0023

Granted

03764596.7

15-Jul-2003

1543020

13-Apr-2011

AVSI0023

Granted

03764596.7

15-Jul-2003

1543020

13-Apr-2011

AVSI0023

Granted

03764596.7

15-Jul-2003

1543020

13-Apr-2011

AVSI0023

Granted

10/619939

15-Jul-2003

7316925

08-Jan-2008

AVSI0043

Granted

11339894

26-Jan-2006

7846720

07-Dec-2010

AVSI0043

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

Granted

01979579.8

04-Oct-2001

1328653

01-Aug-2012

UPVG0044

Granted

01979579.8

04-Oct-2001

1328653

01-Aug-2012

- 82 -

UPVG0044

Granted

01979579.8

04-Oct-2001

1328653

01-Aug-2012

UPVG0044

Granted

01979579.8

04-Oct-2001

1328653

01-Aug-2012

UPVG0044

Granted

01979579.8

04-Oct-2001

1328653

01-Aug-2012

UPVG0044

Granted

2002-532657

04-Oct-2001

4472250

12-Mar-2010

UPVG0044

Granted

09971806

04-Oct-2001

6733994

11-May-2004

UPVG0044

Published

PCT/US01/31451

04-Oct-2001

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

Granted

09/115407

14-Jul-1998

6,410,228

25-Jun-2002

AVSI0027

Granted

2003295366

30-Oct-2003

2003295366

08-Mar-2012

AVSI0027

Published

2504593

30-Oct-2003

AVSI0027

Granted

92130336

30-Oct-2003

290174

21-Nov-2007

VAL1009

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

Published

PCT/US12/24905

13-Feb-2012

UPVG0037

Expired

61442162

11-Feb-2011

UPVG0037

Published

13622965

09-Sep-2012

UPVG0037

Pending

13984771

09-Aug-2013

UPVG0037

Filed

13-Feb-2012

UPVG0037

Filed

13-Feb-2012

UPVG0037

Filed

13-Feb-2012

UPVG0037

Filed

13-Feb-2012

UPVG0037

Filed

13-Feb-2012

UPVG0037

Filed

13-Feb-2012

UPVG0037

Filed

13-Feb-2012

UPVG0037

Filed

13-Feb-2012

UPVG0037

Filed

13-Feb-2012

UPVG0037

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

Filed

14-Nov-2011

UPVG0036

Pending

BR11 2013 011705.2

14-Nov-2011

UPVG0036

Pending

2720277

14-Nov-2011

UPVG0036

Filed

14-Nov-2011

UPVG0036

Pending

201390689

14-Nov-2011

UPVG0036

Pending

11839215.8

14-Nov-2011

UPVG0036

Pending

4088/KOLNP/2013

14-Nov-2011

UPVG0036

Pending

100078282

14-Nov-2011

UPVG0036

Pending

10 ###-###-####

14-Nov-2011

UPVG0036

Pending

MX/a/2013/005195

14-Nov-2011

UPVG0036

Expired

61413176

12-Nov-2010

UPVG0036

Expired

61417817

29-Nov-2010

UPVG0036

Pending

13883978

29-Jul-2013

UPVG0036

Reportable

PCT/US11/60592

14-Nov-2011

UPVG0036

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)

Appendix 14.3

Form of Press Release


*Media Release*

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

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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, ***@***

Inovio

Investors: Bernie Hertel, Inovio Pharmaceuticals, +1858 ###-###-####, ***@***

Media: Jeff Richardson, Inovio Pharmaceuticals, +1 ###-###-####, ***@***

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