INOVIO PHARMACEUTICALS, INC. (Form: 10-Q, Received: 08/09/2021 16:02:24)

Jun 30, 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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q


☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2021


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE TRANSITION PERIOD FROM TO

COMMISSION FILE NO. 001-14888

INOVIO PHARMACEUTICALS, INC.

(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)


Delaware						33-0969592
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)

660 W. GERMANTOWN PIKE, SUITE 110

PLYMOUTH MEETING, PA 19462

(Address of principal executive offices)

REGISTRANT’S TELEPHONE NUMBER, INCLUDING AREA CODE: (267) 440-4200

SECURITIES REGISTERED PURSUANT TO SECTION 12(B) OF THE ACT:


Title of Each Class	Trading Symbol(s)	Name of Each Exchange on Which Registered
COMMON STOCK, $0.001 PAR VALUE	INO	Nasdaq Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and "emerging growth company" in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer

☒

Accelerated filer

☐

Non-accelerated filer

☐

Smaller reporting company

☐

Emerging growth company

☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

The number of shares outstanding of the Registrant’s Common Stock, $0.001 par value, was 210,356,896 as of August 6, 2021.

INOVIO PHARMACEUTICALS, INC.

FORM 10-Q

For the Quarterly Period Ended June 30, 2021

INDEX


Part I. Financial Information			1
Item 1. Financial Statements			1
a) Condensed Consolidated Balance Sheets			2
b) Condensed Consolidated Statements of Operations			3
c) Condensed Consolidated Statements of Comprehensive Loss			4
d) Condensed Consolidated Statements of Stockholders' Equity			5
e) Condensed Consolidated Statements of Cash Flows			7
f) Notes to Condensed Consolidated Financial Statements			9
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations			31
Item 3. Quantitative and Qualitative Disclosures About Market Risk			36
Item 4. Controls and Procedures			36

Part II. Other Information			38
Item 1. Legal Proceedings			38
Item 1A. Risk Factors			39
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			59
Item 3. Defaults Upon Senior Securities			59
Item 4. Mine Safety Disclosures			59
Item 5. Other Information			59
Item 6. Exhibits			59
Signatures			61

SUMMARY OF THE MATERIAL RISKS ASSOCIATED WITH OUR BUSINESS

Our business is subject to a number of risks, including risks that may prevent us from achieving our business objectives or may adversely affect our business, financial condition, results of operations, cash flows and prospects. These risks are discussed more fully in Item 1A. Risk Factors herein. These risks include, but are not limited to, the following:

•Our business could be adversely affected by the effects of health epidemics, including the global COVID-19 pandemic.

•We have incurred significant losses in recent years, expect to incur significant net losses in the foreseeable future and may never become profitable.

•We are currently subject to litigation and may become subject to additional litigation, which could harm our business, financial condition and reputation.

•Our planned Phase 3 clinical trial of INO-4800 in the United States as a potential COVID-19 vaccine has been placed on partial clinical hold by the U.S. FDA, which may cause delays in our ability to conduct a Phase 3 clinical trial in the United States.

•There can be no assurance that the product we are developing for COVID-19 would be granted an Emergency Use Authorization by the FDA or similar authorization by regulatory authorities outside of the United States if we were to decide to apply for such an authorization. The option of seeking an Emergency Use Authorization may no longer exist if the public health emergency has expired or if a sufficient supply of COVID-19 vaccines have obtained full Biologics License Approval, or foreign equivalent, by the time we are ready to submit an application. If we do not timely apply for such an emergency use authorization or, if we do apply and no authorization is granted or, once granted, it is terminated, we will be unable to sell our product in the near future and instead, will be required to pursue the biologic licensure process in order to sell our product, which is lengthy and expensive.

•Delays in the commencement or completion of clinical testing could result in increased costs to us and delay or limit our ability to generate revenues.

•None of our human vaccine candidates, including INO-4800, or our immunotherapy and DNA encoded monoclonal antibody product candidates have been approved for sale, and we may never develop commercially successful vaccine, immunotherapy or monoclonal antibody products.

•We will need substantial additional capital to develop our DNA vaccines, DNA immunotherapies and dMAb programs and electroporation delivery technology.

•If we lose or are unable to secure collaborators or partners, or if our collaborators or partners do not apply adequate resources to their relationships with us, our product development and potential for profitability will suffer.

•A small number of licensing partners and government contracts account for a substantial portion of our revenue.

•We have agreements with government agencies, which are subject to termination and uncertain future funding.

•We face intense and increasing competition and many of our competitors have significantly greater resources and experience.

•If we and the contract manufacturers upon whom we rely fail to produce our electroporation devices and product candidates in the volumes that we require on a timely basis, or at all, or fail to comply with their obligations to us or with stringent regulations, we may face delays in the development and commercialization of our electroporation equipment and product candidates.

•It is difficult and costly to generate and protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection.

•If we are sued for infringing intellectual property rights of third parties, it will be costly and time-consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.

Part I. Financial Information

Item 1. Financial Statements

INOVIO PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS


	June 30, 2021		December 31, 2020
	(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	58,925,302	$	250,728,118
Short-term investments	384,752,382		160,914,935
Accounts receivable	13,128,330		18,559,967
Accounts receivable from affiliated entities	722,941		503,782
Prepaid expenses and other current assets	84,592,179		40,357,456
Prepaid expenses and other current assets from affiliated entities	303,491		106,432

Total current assets	542,424,625		471,170,690
Fixed assets, net	18,111,288		11,348,144
Investment in affiliated entity	3,908,709		4,460,366
Investment in Geneos	—		434,387
Intangible assets, net	2,879,896		3,146,770
Goodwill	10,513,371		10,513,371
Operating lease right-of-use assets	12,173,414		12,741,296
Other assets	1,830,866		25,957,448
Total assets	$	591,842,169	$	539,772,472
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued expenses	$	30,095,578	$	21,203,808
Accounts payable and accrued expenses due to affiliated entities	1,773,846		642,969
Accrued clinical trial expenses	10,416,164		9,950,345
Deferred revenue	109,128		46,628

Operating lease liability	2,463,878		2,329,394
Grant funding liability	6,859,155		7,474,310
Grant funding liability from affiliated entities	31,250		58,500

Total current liabilities	51,748,999		41,705,954
Deferred revenue, net of current portion	71,788		79,214

Convertible senior notes	14,536,448		14,139,988
Convertible bonds	—		4,515,834
Operating lease liability, net of current portion	16,797,476		18,063,515
Deferred tax liabilities	32,046		32,046
Grant funding liability from affiliated entity, net of current portion	37,500		37,500
Other liabilities	64,141		57,663
Total liabilities	83,288,398		78,631,714
Stockholders’ equity:
Preferred stock	—		—
Common stock	210,146		186,851
Additional paid-in capital	1,551,348,435		1,367,406,869
Accumulated deficit	(1,042,738,901)		(906,196,812)
Accumulated other comprehensive loss	(265,909)		(256,150)
Total Inovio Pharmaceuticals, Inc. stockholders’ equity	508,553,771		461,140,758


Total liabilities and stockholders’ equity	$	591,842,169	$	539,772,472

See accompanying notes to unaudited condensed consolidated financial statements.

INOVIO PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)


	Three Months Ended June 30,				Six Months Ended June 30,
	2021		2020		2021		2020
Revenues:
Revenue under collaborative research and development arrangements	$	82,923	$	74,102	$	122,538	$	145,602
Revenue under collaborative research and development arrangements with affiliated entities	74,787		95,146		124,736		1,267,272
Other revenue	115,114		97,939		396,671		181,587


Total revenues	272,824		267,187		643,945		1,594,461
Operating expenses:
Research and development	70,808,418		22,376,575		109,852,836		41,487,763
General and administrative	12,666,341		11,071,510		26,547,535		18,519,864

Total operating expenses	83,474,759		33,448,085		136,400,371		60,007,627
Loss from operations	(83,201,935)		(33,180,898)		(135,756,426)		(58,413,166)
Other income (expense):
Interest income	928,111		1,067,399		1,697,347		1,483,968
Interest expense	(466,726)		(2,846,641)		(979,760)		(5,650,396)

Change in fair value of derivative liability	—		(97,755,000)		—		(110,976,977)
Gain (loss) on investment in affiliated entities	278,818		(3,883,176)		(551,657)		9,298,443
Net unrealized gain (loss) on available-for-sale equity securities	136,493		4,358,634		(711,465)		(691,458)
Other income (expense), net	185,281		(152,102)		194,259		(577,602)
Gain on deconsolidation of Geneos	—		4,121,075		—		4,121,075



Net loss before share in net loss of Geneos	(82,139,958)		(128,270,709)		(136,107,702)		(161,406,113)

Share in net loss of Geneos	—		(901,757)		(434,387)		(901,757)
Net loss	(82,139,958)		(129,172,466)		(136,542,089)		(162,307,870)
Net loss attributable to non-controlling interest	—		469,407		—		1,063,757
Net loss attributable to Inovio Pharmaceuticals, Inc.	$	(82,139,958)	$	(128,703,059)	$	(136,542,089)	$	(161,244,113)
Net loss per share attributable to Inovio Pharmaceuticals, Inc. stockholders
Basic and diluted	$	(0.39)	$	(0.83)	$	(0.66)	$	(1.15)

Weighted average number of common shares outstanding
Basic and diluted	209,561,064		155,807,054		206,007,497		140,215,158

See accompanying notes to unaudited condensed consolidated financial statements.

INOVIO PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(Unaudited)


	Three Months Ended June 30,				Six Months Ended June 30,
	2021		2020		2021		2020
Net loss	$	(82,139,958)	$	(129,172,466)	$	(136,542,089)	$	(162,307,870)
Other comprehensive income (loss):

Foreign currency translation	2,478		—		(11,941)		—
Unrealized gain (loss) on short-term investments, net of tax	(2,679)		846,900		2,182		(1,082,638)


Comprehensive loss	(82,140,159)		(128,325,566)		(136,551,848)		(163,390,508)
Comprehensive loss attributable to non-controlling interest	—		469,407		—		1,063,757
Comprehensive loss attributable to Inovio Pharmaceuticals, Inc.	$	(82,140,159)	$	(127,856,159)	$	(136,551,848)	$	(162,326,751)

See accompanying notes to unaudited condensed consolidated financial statements.

INOVIO PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY

(Unaudited)


	Three and Six Months Ended June 30, 2021
	Preferred stock			Common stock
	Number of shares	Amount		Number of shares	Amount		Additional paid-in capital		Accumulated deficit		Accumulated other comprehensive income (loss)		Total stockholders’ equity
Balance at December 31, 2020	9	$	—	186,851,493	$	186,851	$	1,367,406,869	$	(906,196,812)	$	(256,150)	$	461,140,758
Issuance of common stock for cash, net of financing costs of $531,000		—		20,355,000	20,355		162,084,675		—		—		162,105,030
Conversion of December 2019 Bonds to common stock	—	—		1,009,450	1,009		4,376,883		—		—		4,377,892
Exercise of stock options for cash and vesting of RSUs, net of tax payments	—	—		1,118,093	1,118		(1,202,907)		—		—		(1,201,789)
Stock-based compensation	—	—		—	—		9,595,947		—		—		9,595,947
Net loss attributable to common stockholders	—	—		—	—		—		(54,402,131)		—		(54,402,131)
Unrealized gain on short-term investments	—	—		—	—		—		—		4,861		4,861
Foreign currency translation	—	—		—	—		—		—		(14,419)		(14,419)
Balance at March 31, 2021	9	$	—	209,334,036	$	209,333	$	1,542,261,467	$	(960,598,943)	$	(265,708)	$	581,606,149

Exercise of stock options for cash and vesting of RSUs, net of tax payments	—	—		812,844	813		3,440,610		—		—		3,441,423
Stock-based compensation	—	—		—	—		5,646,358		—		—		5,646,358
Net loss attributable to common stockholders	—	—		—	—		—		(82,139,958)		—		(82,139,958)
Unrealized loss on short-term investments	—	—		—	—		—		—		(2,679)		(2,679)
Foreign currency translation	—	—		—	—		—		—		2,478		2,478
Balance at June 30, 2021	9	$	—	210,146,880	$	210,146	$	1,551,348,435	$	(1,042,738,901)	$	(265,909)	$	508,553,771


	Three and Six Months Ended June 30, 2020
	Preferred stock			Common stock
	Number of shares	Amount		Number of shares	Amount		Additional paid-in capital		Accumulated deficit		Accumulated other comprehensive income (loss)		Non- controlling interest		Total stockholders’ equity






























Balance at December 31, 2019	23	$	—	101,361,034	$	101,361	$	742,646,785	$	(739,785,655)	$	472,608	$	1,969,759	$	5,404,858
Issuance of common stock for cash	—	—		43,148,952	43,149		208,198,784		—		—		—		208,241,933
Exercise of stock options for cash and vesting of RSUs, net of tax payments	—	—		1,405,114	1,405		3,099,298		—		—		—		3,100,703
Stock-based compensation	—	—		—	—		4,017,761		—		—		(16,208)		4,001,553
Acquisition of non-controlling interest in Geneos	—	—		—	—		—		—		—		2,169,998		2,169,998
Net loss attributable to common stockholders	—	—		—	—		—		(32,541,054)		—		(594,350)		(33,135,404)
Unrealized loss on short-term investments	—	—		—	—		—		—		(1,929,538)		—		(1,929,538)
Balance at March 31, 2020	23	$	—	145,915,100	$	145,915	$	957,962,628	$	(772,326,709)	$	(1,456,930)	$	3,529,199	$	187,854,103
Issuance of common stock for cash	—	—		12,041,178	12,041		121,706,881		—		—		—		121,718,922
Conversion of preferred stock to common stock	(14)	—		5,147	5		(5)		—		—		—		—
Exercise of stock options for cash and vesting of RSUs, net of tax payments	—	—		794,986	795		4,421,449		—		—		—		4,422,244
Stock-based compensation	—	—		—	—		3,654,289		—		—		8,146		3,662,435
Acquisition of non-controlling interest in Geneos	—	—		—	—		—		—		—		209,971		209,971
Deconsolidation of Geneos	—	—		—	—		—		—		—		(3,181,640)		(3,181,640)
Net loss attributable to common stockholders	—	—		—	—		—		(128,703,059)		—		(469,407)		(129,172,466)
Unrealized gain on short-term investments	—	—		—	—		—		—		846,900		—		846,900
Balance at June 30, 2020	9	$	—	158,756,411	$	158,756	$	1,087,745,242	$	(901,029,768)	$	(610,030)	$	96,269	$	186,360,469

See accompanying notes to unaudited condensed consolidated financial statements.

INOVIO PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)


	Six Months Ended June 30,
	2021		2020
Cash flows from operating activities:
Net loss	$	(136,542,089)	$	(162,307,870)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	1,361,595		1,608,060
Amortization of intangible assets	266,874		273,540

Change in fair value of derivative liability	—		110,976,977
Stock-based compensation	15,242,305		7,663,988


Non-cash interest expense	435,445		3,013,942

(Gain) loss on short-term investments	(153,252)		576,001

Settlement of receivable with shares of common stock from affiliated entity (PLS)	—		(1,713,770)
Gain on deconsolidation of Geneos	—		(4,121,075)
Gain (loss) on equity investment in affiliated entities	551,657		(9,298,443)
Share of net loss in Geneos	434,387		901,757


Net unrealized loss on available-for-sale equity securities	711,465		691,458
Non-cash lease expense	567,882		517,865


Unrealized transaction gain on foreign-currency denominated debt	(176,927)		(474,071)
Changes in operating assets and liabilities:
Accounts receivable	5,431,637		(2,813,086)
Accounts receivable from affiliated entities	(219,159)		865,832
Prepaid expenses and other current assets	(51,944,060)		(3,084,082)
Prepaid expenses and other current assets from affiliated entities	(197,059)		(1,330,601)

Other assets	24,126,582		116,242
Accounts payable and accrued expenses	8,891,770		(732,774)
Accrued clinical trial expenses	465,819		2,882,486
Accounts payable and accrued expenses due to affiliated entities	1,130,877		4,634
Deferred revenue	55,074		(92,426)
Deferred revenue from affiliated entities	(6,250)		62,500

Operating lease right-of-use assets and liabilities, net	(1,131,555)		(1,022,951)
Grant funding liability	(615,155)		4,265,023
Grant funding liability from affiliated entities	(21,000)		(63,050)

Other liabilities	6,478		29,686
Net cash used in operating activities	(131,326,659)		(52,604,208)
Cash flows from investing activities:
Purchases of investments	(307,857,113)		(138,698,249)
Proceeds from sale or maturity of investments	83,466,967		47,455,067
Purchases of capital assets	(418,734)		(176,534)




Decrease in cash resulting from the deconsolidation of Geneos	—		(2,774,851)
Net cash used in investing activities	(224,808,880)		(94,194,567)
Cash flows from financing activities:


Proceeds from issuance of common stock, net of issuance costs	162,105,030		329,960,855
Proceeds from stock option exercises	6,154,794		9,599,514
Taxes paid related to net share settlement of equity awards	(3,915,160)		(2,076,567)
Acquisition of non-controlling interest	—		2,379,969
Proceeds from Geneos issuance of note payable	—		171,620
Net cash provided by financing activities	164,344,664		340,035,391
Effect of exchange rate changes on cash and cash equivalents	(11,941)		—


(Decrease) Increase in cash and cash equivalents	(191,802,816)		193,236,616
Cash and cash equivalents, beginning of period	250,728,118		22,196,097
Cash and cash equivalents, end of period	$	58,925,302	$	215,432,713

Supplemental disclosures:
Amounts accrued for purchases of property and equipment	$	—	$	1,620
Interest paid	$	544,315	$	2,636,454

See accompanying notes to unaudited condensed consolidated financial statements.

INOVIO PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

1. Organization and Operations

Inovio Pharmaceuticals, Inc. (the “Company” or “INOVIO”), is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with human papillomavirus ("HPV"). INOVIO's DNA medicines pipeline is comprised of three types of product candidates: DNA vaccines, DNA immunotherapies and DNA encoded monoclonal antibodies ("dMAbs"). In clinical trials, INOVIO has demonstrated that DNA medicines can be delivered directly into cells in the body through its proprietary smart device to consistently activate robust and fully functional T cell and antibody responses against targeted pathogens and cancers.

The Company's novel DNA medicine candidates are made using its proprietary SynCon® technology that creates optimized plasmids, which are circular strands of DNA that instruct a cell to produce antigens to help the person’s immune system recognize and destroy cancerous or virally infected cells.

INOVIO's patented CELLECTRA® smart delivery devices provide optimized uptake of its DNA medicines within the cell, overcoming a key limitation of other DNA-based technology approaches.

Human clinical trial data to date have shown a favorable safety profile of INOVIO's DNA medicines delivered directly into cells in the body using the CELLECTRA® smart device in more than 7,000 administrations across more than 3,000 patients.

INOVIO's corporate strategy is to advance, protect and, once approved, commercialize its novel DNA medicines to meet urgent and emerging global health needs. The Company continues to advance and clinically validate an array of DNA medicine candidates that target HPV-associated diseases, cancer, and infectious diseases, such as COVID-19. The Company aims to advance these candidates through commercialization and continue to leverage third-party resources through collaborations and partnerships, including product license agreements.

The Company's partners and collaborators include ApolloBio Corporation., AstraZeneca, Beijing Advaccine, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations ("CEPI"), The U.S. Department of Defense ("DoD"), Defense Advanced Research Projects Agency ("DARPA"), GeneOne Life Science, HIV Vaccines Trial Network, the U.S. Defense Threat Reduction Agency’s Medical CBRN Defense Consortium ("MCDC"), International Vaccine Institute ("IVI"), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron Pharmaceuticals, Inc., Richter-Helm BioLogics, Thermo Fisher Scientific, the University of Pennsylvania, the Walter Reed Army Institute of Research, and The Wistar Institute.

The Company and its collaborators are currently conducting or planning clinical studies of its DNA medicines for COVID-19; Middle East Respiratory Syndrome, or MERS; Lassa fever; HIV; Ebola; as well as HPV-associated precancers, including cervical, vulvar, and anal dysplasia; HPV-associated cancers, including head & neck, cervical, anal, penile, vulvar, and vaginal; other HPV-associated disorders, such as recurrent respiratory papillomatosis, or RRP; glioblastoma multiforme, or GBM; and prostate cancer.

INOVIO was incorporated in Delaware in June 2001 and has its principal executive offices in Plymouth Meeting, Pennsylvania.

2. Basis of Presentation, Liquidity and Risks and Uncertainties

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements of Inovio have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) as contained in the Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") for interim financial information and with instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The condensed consolidated balance sheet as of June 30, 2021, the condensed consolidated statements of operations, the condensed consolidated statements of comprehensive loss and the condensed consolidated statements of stockholders' equity for the three and six months ended June 30, 2021 and 2020 and the condensed consolidated statements of cash flows for the six months ended June 30, 2021 and 2020 are unaudited, but include all adjustments (consisting of normal recurring adjustments) that the Company considers necessary for a fair presentation of the financial position, results of operations, cash flows and changes in stockholders' equity for the periods presented. The results of operations for the three and six months ended June 30, 2021 shown herein are not necessarily indicative of the results that may be expected for the year ending December 31, 2021, or for any other period. These unaudited financial statements, and notes thereto, should be read in

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conjunction with the audited consolidated financial statements for the year ended December 31, 2020, included in the Company's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on March 1, 2021. The balance sheet at December 31, 2020 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements.

In June 2020, the Company formed a wholly-owned subsidiary, Inovio Asia LLC, under the laws of South Korea, through which the Company intends to advance its corporate development projects and other functions in South Korea and other Asian countries.

These unaudited condensed consolidated financial statements include the accounts of Inovio Pharmaceuticals, Inc. and its subsidiaries. As of June 30, 2021, the Company consolidated its wholly-owned subsidiary Inovio Asia LLC. On December 31, 2020, former wholly-owned subsidiaries Genetronics, Inc. and VGX Pharmaceuticals Inc. and former majority-owned subsidiary VGX Animal Health, Inc. were merged into Inovio Pharmaceuticals, Inc. All intercompany accounts and transactions were eliminated upon consolidation. As of June 1, 2020, the Company deconsolidated its former subsidiary Geneos Therapeutics, Inc. ("Geneos"), as the Company no longer held a controlling financial interest. Refer to Footnote 17 for further discussion.

Liquidity

The Company incurred a net loss attributable to common stockholders of $82.1 million and $136.5 million for the three and six months ended June 30, 2021, respectively. The Company had working capital of $490.7 million and an accumulated deficit of $1.0 billion as of June 30, 2021. The Company has incurred losses in each year since its inception and expects to continue to incur significant expenses and operating losses for the foreseeable future in connection with the research and preclinical and clinical development of its product candidates. The Company’s cash, cash equivalents and short-term investments of $443.7 million as of June 30, 2021 are sufficient to support the Company's operations for a period of at least 12 months from the date of issuance of these financial statements.

In order to continue to fund future research and development activities, the Company will need to seek additional capital. This may occur through strategic alliance and licensing arrangements, grant agreements and/or future public or private debt or equity financings including use of potential future At-the-Market Equity Offering Sales Agreements (“Sales Agreements”). The Company has a history of conducting debt and equity financings, including the receipt of net proceeds of $162.1 million from a January 2021 underwritten public offering and net proceeds of $454.5 million under past Sales Agreements for the year ended December 31, 2020. However, sufficient funding may not be available in the future, or if available, may be on terms that significantly dilute or otherwise adversely affect the rights of existing stockholders. If adequate funds are not available, the Company may need to delay, reduce the scope of or put on hold one or more of its clinical and/or preclinical programs.

The Company’s ability to continue its operations is dependent upon its ability to obtain additional capital in the future and achieve profitable operations. The Company expects to continue to rely on outside sources of financing to meet its capital needs and the Company may never achieve positive cash flow. These condensed consolidated financial statements do not include any adjustments to the specific amounts and classifications of assets and liabilities, which might be necessary should Inovio be unable to continue as a going concern. The Company's condensed consolidated financial statements as of and for the three and six months ended June 30, 2021 have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business for the foreseeable future. The Company has evaluated subsequent events after the balance sheet date through the date it issued these condensed consolidated financial statements.

The Company is and, from time to time, may in the future be subject to various legal proceedings and claims arising in the ordinary course of business. The Company assesses contingencies to determine the degree of probability and range of possible loss for potential accrual in its consolidated financial statements. An estimated loss contingency is accrued in the consolidated financial statements if it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Legal proceedings, including litigation, government investigations and enforcement actions, could result in material costs, occupy significant management resources and entail civil and criminal penalties, even if the Company ultimately prevails. Any of the foregoing consequences could result in serious harm to the Company’s business, results of operations and financial condition.

Risks and Uncertainties

The global pandemic resulting from COVID-19, caused by a novel strain of coronavirus, SARS-CoV-2, has caused national and global economic and financial market disruptions. The impact of this pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will continue to cause significant disruptions to the global economy, as well as businesses and capital markets around the world.

The Company continues to closely monitor the impact of the COVID-19 pandemic on its employees, collaborators and service providers. The extent to which the pandemic will continue to impact the Company's business and operations will depend on future developments, including travel restrictions and social distancing in the United States and other countries, and the

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effectiveness of actions taken in the United States and other countries to contain and treat the disease, including mass vaccination efforts, that are highly uncertain as of the date the Company is issuing these financial statements.

3. Critical Accounting Policies

Collaboration Agreements

The Company assesses whether its collaboration agreements are subject to ASC Topic 808: Collaborative Arrangements (“Topic 808”) based on whether they involve joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. To the extent that the arrangement falls within the scope of Topic 808 and the Company concludes that its collaboration partner is not a customer, the Company presents such payments as a reduction of research and development expense. If payments from the collaboration partner to the Company represent consideration from a customer, then the Company accounts for those payments within the scope of Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (“Topic 606”).

Revenue Recognition

The Company recognizes revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies its performance obligations. At contract inception, the Company assesses the goods or services agreed upon within each contract and assess whether each good or service is distinct and determine those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

Collaborative Arrangements

The Company enters into collaborative arrangements with partners that typically include payment of one or more of the following: (i) license fees; (ii) product supply services; (iii) milestone payments related to the achievement of developmental, regulatory, or commercial goals; and (iv) royalties on net sales of licensed products. Where a portion of non-refundable, upfront fees or other payments received are allocated to continuing performance obligations under the terms of a collaborative arrangement, they are recorded as deferred revenue and recognized as revenue when (or as) the underlying performance obligation is satisfied.

As part of the accounting for these arrangements, the Company must develop estimates and assumptions that require judgment of management to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligation. The standalone selling price may include items such as forecasted revenues, development timelines, discount rates and probabilities of technical and regulatory success. The Company evaluates each performance obligation to determine if it can be satisfied at a point in time or over time. In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price.

License Fees

If a license to intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company will recognize revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company will utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

Product Supply Services

Arrangements that include a promise for future supply of drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options. The Company will assess if these options provide a material right to the licensee and if so, they will be accounted for as separate performance obligations. The Company evaluates whether it is the principal or agent in the arrangement. The Company had determined that it is the principal in the current arrangements as the Company controls the product supply before it is transferred to the customer.

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Milestone Payments

At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company's or its collaboration partner’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achieving such milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration or other revenues and earnings in the period of adjustment.

Royalties

For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its collaborative arrangements.

Grants

The Company accounts for various grant agreements under the contributions guidance under Subtopic 958-605, Not-for-Profit Entities-Revenue Recognition, which is outside the scope of Topic 606, as the government agencies granting the Company funds are not receiving reciprocal value for their contributions. All contributions received from current grant agreements are recorded as a contra-expense as opposed to revenue on the condensed consolidated statement of operations.

Leases

For its long-term operating leases, the Company recognizes an operating lease right-of-use asset and an operating lease liability on its condensed consolidated balance sheets. The lease liability is determined as the present value of future lease payments using an estimated rate of interest that the Company would pay to borrow equivalent funds on a collateralized basis at the lease commencement date. The right-of-use asset is based on the liability adjusted for any prepaid or deferred rent. The Company determines the lease term at the commencement date by considering whether renewal options and termination options are reasonably assured of exercise.

Fixed rent expense for the Company's operating leases is recognized on a straight-line basis over the term of the lease and is included in operating expenses on the condensed consolidated statements of operations. Variable lease payments including lease operating expenses are recorded as incurred.

Research and Development Expenses

The Company’s activities have largely consisted of research and development efforts related to developing electroporation delivery technologies, DNA vaccines, DNA immunotherapies and dMABs. Research and development expenses consist of expenses incurred in performing research and development activities including salaries and benefits, facilities and other overhead expenses, clinical trials, contract services and other outside expenses. Research and development expenses are charged to operations as they are incurred. These expenses result from the Company's independent research and development efforts as well as efforts associated with collaborations and licensing arrangements. The Company reviews and accrues clinical trial expense based on work performed, which relies on estimates of total costs incurred based on patient enrollment, completion of studies and other events. Accrued clinical trial costs are subject to revisions as trials progress. Revisions are charged to expense in the period in which the facts that give rise to the revision become known. Historically, revisions have not resulted in material changes to research and development expense; however, a modification in the protocol of a clinical trial or cancellation of a trial could result in a charge to the Company's results of operations.

Advance payments for goods or services to be rendered in the future for use in research and development activities are deferred and included in prepaid expenses and other assets. The deferred amounts are expensed as the related goods are delivered or the services are performed.

Valuation of Intangible Assets and Goodwill

Intangible assets are amortized over their estimated useful lives ranging from two to 18 years. Acquired intangible assets are continuously being developed for the future economic viability contemplated at the time of acquisition. The Company is concurrently conducting preclinical studies and clinical trials using the acquired intangibles and has entered into licensing agreements for the use of these acquired intangibles.

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License costs are recorded based on the fair value of consideration paid and are amortized using the straight-line method over the shorter of the expected useful life of the underlying patents or the term of the related license agreement to the extent the license has an alternative future use. As of June 30, 2021 and December 31, 2020, the Company’s intangible assets resulting from the acquisition of Inovio AS and Bioject Medical Technologies, Inc. ("Bioject"), and additional intangibles including license costs, net of accumulated amortization, totaled $2.9 million and $3.1 million, respectively.

The determination of the value of intangible assets requires management to make estimates and assumptions that affect the Company’s condensed consolidated financial statements. The Company assesses potential impairments to intangible assets when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. The Company’s judgments regarding the existence of impairment indicators and future cash flows related to intangible assets are based on operational performance of its acquired businesses, market conditions and other factors. If impairment is indicated, the Company will reduce the carrying value of the intangible asset to fair value. While current and historical operating and cash flow losses are potential indicators of impairment, the Company believes the future cash flows to be received from its intangible assets will exceed the intangible assets’ carrying value, and accordingly, the Company has not recognized any impairment losses through June 30, 2021.

Goodwill represents the excess of acquisition cost over the fair value of the net assets of acquired businesses. Goodwill is reviewed for impairment at least annually at November 30, or more frequently if an event occurs indicating the potential for impairment. During its goodwill impairment review, the Company may assess qualitative factors to determine whether it is more likely than not that the fair value of its reporting unit is less than its carrying amount, including goodwill. The qualitative factors include, but are not limited to, macroeconomic conditions, industry and market considerations, and the overall financial performance of the Company. If, after assessing the totality of these qualitative factors, the Company determines that it is not likely that the fair value of its reporting unit is less than its carrying amount, then no additional assessment is deemed necessary. Otherwise, the Company will proceed to perform the impairment test in which the fair value of the reporting unit is compared with its carrying amount, and an impairment charge will be recorded for the amount by which the carrying amount exceeds the reporting unit's fair value, if any. The Company performed its annual assessment for goodwill impairment as of November 30, 2020, identifying no impairment.

Although there are inherent uncertainties in this assessment process, the estimates and assumptions the Company is using are consistent with its internal planning. If these estimates or their related assumptions change in the future, the Company may be required to record an impairment charge on all or a portion of its goodwill and intangible assets. Furthermore, the Company cannot predict the occurrence of future impairment triggering events nor the impact such events might have on its reported asset values. Future events could cause the Company to conclude that impairment indicators exist and that goodwill or other intangible assets associated with its acquired businesses are impaired. Any resulting impairment loss could have an adverse impact on the Company’s results of operations. See Note 8 for further discussion of the Company’s goodwill and intangible assets.

Foreign Currency Translation

The functional and presentation currency of the Company is the U.S. dollar. Transactions denominated in a currency other than the functional currency are recorded on the initial recognition at the exchange rate at the date of the transaction. After initial recognition monetary assets and liabilities denominated in foreign currency are translated at the end of each reporting period into the functional currency at the exchange rate at that date. The cumulative translation adjustment is included in the accumulated other comprehensive income (loss) within the statement of stockholders' equity. Exchange differences are included in general and administrative expenses in the condensed consolidated statement of operations. Non- monetary assets and liabilities measured at cost are translated at the exchange rate at the date of the transaction.

Variable Interest Entities (VIE)

The Company evaluates its ownership, contractual and other interests in entities that are not wholly-owned to determine if these entities are VIEs, and, if so, whether the Company is the primary beneficiary of the VIE. In determining whether the Company is the primary beneficiary of a VIE and therefore required to consolidate the VIE, the Company applies a qualitative approach that determines whether it has both (1) the power to direct the activities of the VIE that most significantly impact the VIE’s economic performance and (2) the obligation to absorb losses of, or the rights to receive benefits from, the VIE that could potentially be significant to that VIE. The Company will continuously perform this assessment, as changes to existing relationships or future transactions may result in the consolidation or deconsolidation of a VIE.

Equity Investments

Under ASC Topic 321, Investments - Equity Securities, the Company must measure equity investments (except those accounted for under the equity method, those that result in consolidation of the investee and certain other investments) at fair value and recognize any changes in fair value in the condensed consolidated statement of operations. The Company can elect a measurement alternative for equity investments that do not have readily determinable fair values and do not qualify for the practical expedient in ASC 820, Fair Value Measurement, to estimate fair value using the net asset value per share (or its

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equivalent). The Company's equity investments that do not have readily determinable fair values and do not qualify for the net asset value practical expedient for estimating fair value are measured at cost, less any impairments, plus or minus changes resulting from observable price changes in orderly transactions for identifiable or similar investments of the same issuer.

4. Impact of Recently Issued Accounting Standards

The recent accounting pronouncements below may have a significant effect on the Company's financial statements. Recent accounting pronouncements that are not anticipated to have an impact on or are unrelated to the Company's financial condition, results of operations, or related disclosures are not discussed.

Accounting Standards Pending Adoption

ASU No. 2020-06. In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies the guidance on an issuer’s accounting for convertible instruments and contracts in its own equity. The standard is effective for the Company beginning in the first quarter of 2022, with early adoption permitted in the first quarter of 2021. The Company did not elect to early adopt the standard and does not expect ASU 2020-06 to have a material impact to its condensed consolidated financial statements.

5. Revenue Recognition

During the three and six months ended June 30, 2021, the Company recognized total revenue under collaborative research and development arrangements of $75,000 and $125,000, respectively, from its affiliated entity Plumbline Life Sciences, Inc. ("PLS") and $198,000 and $519,000, respectively, from various other contracts as a result of performance obligations being satisfied. Of the total revenue recognized during the three and six months ended June 30, 2021, $35,000 and $39,000, respectively, were in deferred revenue as of December 31, 2020.

6. Short-term Investments

Short-term investments at June 30, 2021 consisted of mutual funds, U.S. treasury securities, certificates of deposit and U.S. agency mortgage-backed securities. Short-term investments at December 31, 2020 consisted of mutual funds, certificates of deposit and U.S. agency mortgage-backed securities. Short-term investments are recorded at fair value, based on current market valuations. Unrealized gains and losses on the Company's short-term debt investments are excluded from earnings and reported as a separate component of other comprehensive loss until realized. Realized gains and losses and unrealized gains and losses on available-for-sale equity securities are included in non-operating other income (expense) on the condensed consolidated statements of operations and are derived using the specific identification method for determining the cost of the securities sold.

During the three and six months ended June 30, 2021, the Company recorded gross realized gain on investments of $358,000 and $358,000, respectively, and gross realized loss on investments of $194,000 and $204,000, respectively. During the three and six months ended June 30, 2020, the Company recorded gross realized gain on investments of $585,000 and $635,000, respectively, and gross realized loss on investments of $686,000 and $1.2 million, respectively. During the three and six months ended June 30, 2021, the Company recorded net unrealized gain (loss) on available-for-sale equity securities of $136,000 and $(711,000), respectively. During the three and six months ended June 30, 2020, the Company recorded net unrealized gain (loss) on available-for-sale equity securities of $4.4 million and $(691,000), respectively. No material balances were reclassified out of accumulated other comprehensive income (loss) for the three and six months ended June 30, 2021 and 2020. Interest and dividends on investments classified as available-for-sale are included in interest income in the condensed consolidated statements of operations. As of June 30, 2021, the Company had 22 available-for-sale securities in an unrealized loss position, of which four with an aggregate total unrealized loss of $211,000 were in such position for longer than 12 months.

The following is a summary of available-for-sale securities as of June 30, 2021 and December 31, 2020:


		As of June 30, 2021
	Contractual Maturity (in years)	Cost		Gross Unrealized Gains		Gross Unrealized Losses		Fair Market Value
Mutual funds	---	$	207,475,699	$	1,563,089	$	(579,056)	$	208,459,732
U.S. treasury securities	Less than 1	170,203,940		10,943		(4,754)		170,210,129

Certificates of deposit	Less than 1	2,972,816		25,684		—		2,998,500
U.S. agency mortgage-backed securities	*	3,130,877		2,782		(49,638)		3,084,021

		$	383,783,332	$	1,602,498	$	(633,448)	$	384,752,382


		As of December 31, 2020
	Contractual Maturity (in years)	Cost		Gross Unrealized Gains		Gross Unrealized Losses		Fair Market Value
Mutual funds	---	$	153,177,675	$	2,339,639	$	(644,140)	$	154,873,174
Certificates of deposit	Less than 1	3,000,000		26,260		(10,000)		3,016,260
U.S. agency mortgage-backed securities	*	3,062,256		—		(36,755)		3,025,501


Total investments		$	159,239,931	$	2,365,899	$	(690,895)	$	160,914,935

*No single maturity date.

The Company periodically reviews its portfolio of available-for-sale debt securities to determine if any investment is impaired due to credit loss or other potential valuation concerns. For the debt securities where the fair value of the investment is less than the amortized cost basis, the Company has assessed at the individual security level for various quantitative factors including, but not limited to, the nature of the investments, changes in credit ratings, interest rate fluctuations, industry analyst reports, and the severity of impairment. Unrealized losses on available-for-sale debt securities as of June 30, 2021 were primarily due to changes in interest rates, and not due to increased credit risks associated with specific securities. The Company does not intend to sell these investments and it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost basis, which may be at maturity. Based on the credit quality of the available-for-sale debt securities that are in an unrealized loss position, and the Company’s estimates of future cash flows to be collected from those securities, the Company believes the unrealized losses are not credit losses. Accordingly, at June 30, 2021, the Company has not recorded an allowance for credit losses related to its available-for-sale debt securities.

7. Fair Value Measurements

The guidance regarding fair value measurements establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets that are accessible at the measurement date; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions.

Assets are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain securities within the fair value hierarchy. The Company does not have any liabilities measured at fair value on a recurring basis and did not have any transfer of assets or liabilities between Level 1, Level 2 and Level 3 of the fair value hierarchy during the six months ended June 30, 2021 or 2020.

The following table presents the Company’s assets that were measured at fair value on a recurring basis, determined using the following inputs as of June 30, 2021:


	Fair Value Measurements at
	June 30, 2021
	Total		Quoted Prices in Active Markets (Level 1)		Significant Other Unobservable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Assets:




Short-term investments
Mutual funds	$	208,459,732	$	208,459,732	$	—	$	—
U.S. treasury securities	170,210,129		170,210,129		—		—

Certificates of deposit	2,998,500		—		2,998,500		—
U.S. agency mortgage-backed securities	3,084,021		—		3,084,021		—
Total short-term investments	384,752,382		378,669,861		6,082,521		—

Investment in affiliated entity	3,908,709		3,908,709		—		—

Total assets measured at fair value	$	388,661,091	$	382,578,570	$	6,082,521	$	—

The following table presents the Company’s assets that were measured at fair value on a recurring basis, determined using the following inputs as of December 31, 2020:


	Fair Value Measurements at
	December 31, 2020
	Total		Quoted Prices in Active Markets (Level 1)		Significant Other Unobservable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Assets:
Cash and cash equivalents
U.S. treasury securities	$	59,996,800	$	59,996,800	$	—	$	—

Short-term investments
Mutual funds	154,873,174		154,873,174		—		—
Certificates of deposit	3,016,260				3,016,260		—
U.S. agency mortgage-backed securities	3,025,501		—		3,025,501		—

Total short-term investments	160,914,935		154,873,174		6,041,761		—

Investment in affiliated entity	4,460,366		4,460,366		—		—

Total assets measured at fair value	$	225,372,101	$	219,330,340	$	6,041,761	$	—

Level 1 assets at June 30, 2021 consisted of mutual funds and U.S. treasury securities held by the Company that are valued at quoted market prices, as well as the Company’s investment in its affiliated entity, PLS. The Company accounts for its investment in 597,808 common shares of PLS based on the closing price of the shares on the Korea New Exchange Market on the applicable balance sheet date. Unrealized gains and losses on the Company's equity securities are reported in the condensed consolidated statement of operations as unrealized gain (loss) on available-for-sale equity securities or as a gain (loss) on investment in affiliated entities.

Level 2 assets at June 30, 2021 consisted of certificates of deposit and U.S. agency mortgage-backed securities held by the Company that are initially valued at the transaction price and subsequently valued, at the end of each reporting period, typically utilizing market observable data. The Company obtains the fair value of its Level 2 assets from a professional pricing service, which may use quoted market prices for identical or comparable instruments, or inputs other than quoted prices that are observable either directly or indirectly. The professional pricing service gathers quoted market prices and observable inputs from a variety of industry data providers. The valuation techniques used to measure the fair value of the Company's Level 2 financial instruments were derived from non-binding market consensus prices that are corroborated by observable market data, quoted market prices for similar instruments, or pricing models such as discounted cash flow techniques. The Company validates the quoted market prices provided by the primary pricing service by comparing the service's assessment of the fair values of the Company's investment portfolio balance against the fair values of the Company's investment portfolio balance obtained from an independent source.

There were no Level 3 assets held as of June 30, 2021.

8. Goodwill and Intangible Assets

The following sets forth the goodwill and intangible assets by major asset class:


		June 30, 2021						December 31, 2020
	Weighted Average Useful Life (Yrs)	Gross		Accumulated Amortization		Net Book Value		Gross		Accumulated Amortization		Net Book Value
Indefinite lived:
Goodwill		$	10,513,371	$	—	$	10,513,371	$	10,513,371	$	—	$	10,513,371
Definite lived:

Licenses	10	1,323,761		(1,291,226)		32,535		1,323,761		(1,276,852)		46,909


Bioject(a)	12	5,100,000		(2,608,889)		2,491,111		5,100,000		(2,468,889)		2,631,111
Other(b)	18	4,050,000		(3,693,750)		356,250		4,050,000		(3,581,250)		468,750
Total intangible assets	11	10,473,761		(7,593,865)		2,879,896		10,473,761		(7,326,991)		3,146,770
Total goodwill and intangible assets		$	20,987,132	$	(7,593,865)	$	13,393,267	$	20,987,132	$	(7,326,991)	$	13,660,141

(a)Bioject intangible assets represent the estimated fair value of developed technology and intellectual property which were recorded from an asset acquisition.

(b)Other intangible assets represent the estimated fair value of acquired intellectual property.

Aggregate amortization expense on intangible assets for the three and six months ended June 30, 2021 was $130,000 and $267,000, respectively. Aggregate amortization expense on intangible assets for the three and six months ended June 30, 2020 was $137,000 and $274,000, respectively. Estimated aggregate amortization expense is $254,000 for the remainder of fiscal year 2021, $493,000 for 2022, $276,000 for 2023, $253,000 for 2024, $253,000 for 2025 and $1.4 million for 2026 and subsequent years combined.

9. Convertible Debt

Convertible Senior Notes

On February 19, 2019 and March 1, 2019, the Company completed a private placement of $78.5 million aggregate principal amount of its 6.50% convertible senior notes due 2024 (the “Notes”). The Notes were sold in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. Net proceeds from the offering were approximately $75.7 million.

The Notes are senior unsecured obligations of the Company and accrue interest payable in cash semi-annually in arrears on March 1 and September 1 of each year, beginning on September 1, 2019, at a rate of 6.50% per annum. The Notes will mature on March 1, 2024, unless earlier converted, redeemed or repurchased. Prior to the close of business on the business day immediately preceding November 1, 2023, the Notes will be convertible at the option of the holders only upon the satisfaction of certain circumstances. Thereafter, the Notes will be convertible at the option of the holders at any time until the close of business on the scheduled trading day immediately before the maturity date. Upon conversion, the Company will pay or deliver, as the case may be, cash, shares of its common stock or a combination of cash and shares of its common stock, at its election. The initial conversion rate will be 185.8045 shares per $1,000 principal amount of Notes (equivalent to an initial conversion price of approximately $5.38 per share), subject to adjustment upon the occurrence of specified events.

The Company may not redeem the Notes prior to March 1, 2022. On or after March 1, 2022, the Company may redeem all, or any portion, of the Notes for cash if the last reported sale price per share of the Company's common stock exceeds 130% of the conversion price on (i) each of at least 20 trading days (whether or not consecutive) during the 30 consecutive trading days ending on, and including, the trading day immediately before the Company sends the related redemption notice; and (ii) the trading day immediately before the date the Company sends such redemption notice. The redemption price will be equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

The Company evaluated the accounting for the issuance of the Notes and concluded that the embedded conversion features meet the requirements for a derivative scope exception for instruments that are both indexed to an entity’s own stock and classified in stockholders’ equity in its condensed consolidated balance sheet, and that the cash conversion guidance applies. Therefore, the Notes issuance proceeds of $78.5 million are allocated first to the liability component based on the fair

value of non-convertible debt with otherwise identical residual terms with the residual proceeds allocated to equity for the conversion features. The Company determined that the fair value of the non-convertible debt upon issuance of the Notes was $62.2 million and recorded this amount as a liability and the offsetting amount as a debt discount as a reduction to the carrying value of the Notes on the closing date. The debt issuance costs associated with the Notes of $2.8 million are allocated to the liability and equity component in the same proportion as the issuance proceeds.

The Company determined that all other features of the Notes were clearly and closely associated with a debt host and did not require bifurcation as a derivative liability, or the fair value of the feature was immaterial to the Company's condensed consolidated financial statements.

The Company determined that the expected life of the Notes was equal to the period through November 1, 2023 as this represents the point at which the Notes are initially subject to repurchase by the Company at the option of the holders. Accordingly, the total debt discount of $18.6 million, inclusive of the fair value of the embedded conversion feature derivative at issuance, is being amortized using the effective interest method through November 1, 2023. The effective interest rate of the liability component is 13.1%.

During the year ended December 31, 2020, the Company received notices for the conversion of $62.1 million of principal amount of the Notes, which were settled for an aggregate of 11,535,660 shares of the Company's common stock. The fair value of the Notes at the date of conversion was $43.7 million compared to the carrying value of $52.5 million, resulting in a $8.8 million gain on extinguishment of debt. This gain was recorded in the condensed consolidated statement of operations. To measure the fair value of the converted Notes as of the conversion dates, the Company engaged a third-party valuation expert and utilized a binomial lattice model.

The balance of the Notes at June 30, 2021 is as follows:


Original principal amount	$	78,500,000
Principal amount converted into common shares	(62,085,000)
Unamortized debt discount on the liability component	(1,963,908)
Unamortized debt issuance cost	(270,302)
Accrued interest	355,658
Net carrying amount	$	14,536,448

For the three and six months ended June 30, 2021, the Company recognized $467,000 and $930,000, respectively, of interest expense related to the Notes, of which $267,000 and $533,000, respectively, related to the contractual interest coupon. For the three and six months ended June 30, 2020, the Company recognized $2.1 million and $4.2 million, respectively, of interest expense related to the Notes, of which $1.3 million and $2.6 million, respectively, related to the contractual interest coupon.

As of June 30, 2021, future minimum payments due under the Notes, representing contractual amounts due, including interest based on the fixed rate of 6.5% per annum, are as follows:



Remainder of 2021	$	534,000
2022	1,067,000
2023	1,067,000
2024	16,948,000

Total	$	19,616,000

August 2019 Convertible Bonds

On August 1, 2019, the Company closed a private placement of the August 2019 Bonds with an aggregate principal amount of 18 billion Korean Won (KRW) (approximately USD $15.0 million based on the exchange rate on the date of issuance) issued to institutional investors led by Korea Investment Partners (KIP), a global venture capital and private equity firm based in Seoul, Korea. Net proceeds from the offering were approximately $14.5 million.

The August 2019 Bonds, which were unsecured obligations of the Company, were issued on August 1, 2019 and accrued interest at a coupon rate of 1.00% per annum, payable quarterly. The August 2019 Bonds were scheduled to mature on July 31, 2024, unless earlier converted or repurchased. On August 3, 2020 the August 2019 Bonds were converted in full into an aggregate of 4,962,364 shares of the Company's common stock, leaving no further August 2019 Bonds outstanding. The initial conversion rate was 211.0595 shares per KRW1,000,000 in principal amount (equivalent to an initial conversion price of

approximately USD $4.00 per share based on the exchange rate as of July 30, 2019), subject to adjustment upon the occurrence of specified events. The conversion rate was reset on January 2, 2020 and was subject to reset quarterly thereafter if the current market price was lower than the conversion price then in effect. The conversion rate as of the date of conversion on August 1, 2020 was 275.69 shares per KRW 1,000,000 in principal amount (equivalent to a conversion price of approximately USD $3.14 per share).

The Company evaluated the accounting for the issuance of the August 2019 Bonds and concluded that the embedded conversion feature was considered a derivative requiring bifurcation from the August 2019 Bonds as it did not meet the equity scope exception due to the fact that it was denominated in a currency other than the Company's functional currency. The fair value of the conversion feature at August 1, 2019 was $7.1 million, which was recorded as a reduction to the carrying value of the debt. This debt discount was being amortized to interest expense over the term of the debt using the effective interest method. The conversion option was accounted for as a derivative liability, which was revalued each reporting period with the resulting change in fair value reflected in other income (expense), net, in the condensed consolidated statements of operations.

The Company determined that all other features of the August 2019 Bonds were clearly and closely associated with a debt host and did not require bifurcation as a derivative liability, or the fair value of the feature was immaterial to the Company's condensed consolidated financial statements.

At their issuance, the Company determined that the expected life of the August 2019 Bonds was equal to the period through August 1, 2022 as this represented the point at which the August 2019 Bonds were initially subject to repurchase by the Company at the option of the holders. Accordingly, the total debt discount of $7.3 million, inclusive of the fair value of the embedded conversion feature derivative at issuance, was being amortized using the effective interest method through August 1, 2022. For the three and six months ended June 30, 2020, the Company recognized $672,000 and $1.3 million, respectively, of interest expense related to the August 2019 Bonds, of which $37,000 and $75,000, respectively, related to the contractual interest coupon.

Immediately prior to the August 2020 conversion in full of the August 2019 Bonds, the derivative liability associated with the August 2019 Bonds was revalued at $84.5 million. The change in fair value of the derivative liability was an increase of $75.7 million, which was recorded on the consolidated statement of operations for the year ended December 31, 2020. To measure the fair value of the derivative liability as of the conversion date, the Company engaged a third-party valuation expert.

Upon conversion, a loss on extinguishment of $8.2 million was recorded on the consolidated statement of operations for the year ended December 31, 2020. This loss represents the difference between (a) the calculated fair value of the derivative liability immediately prior to its derecognition plus the carrying amount of the debt component including any unamortized debt discount and issuance costs and (b) the fair value of the 4,692,364 shares of the Company's common stock issued upon conversion.

December 2019 Convertible Bonds

On December 26, 2019, the Company closed a private placement of convertible promissory notes (the “December 2019 Bonds”) with an aggregate principal amount of 4.7 billion KRW (approximately USD $4.1 million based on the exchange rate on the date of issuance) issued to a Korea-based institutional investor. Net proceeds from the offering were approximately $4.0 million.

The December 2019 Bonds, which were unsecured obligations of the Company, were issued on December 31, 2019 and accrued interest at a coupon rate of 1.00% per annum, payable quarterly. The December 2019 Bonds were scheduled to mature on December 31, 2024, unless earlier converted or repurchased. On March 17, 2021, the December 2019 Bonds were converted in full into an aggregate of 1,009,450 shares of the Company's common stock, leaving no further December 2019 Bonds outstanding. The initial conversion rate was 214.7766 shares per KRW1,000,000 principal amount of Bonds (equivalent to an initial conversion price of approximately USD $4.00 per share based on the exchange rate as of December 19, 2019), subject to adjustment upon the occurrence of certain events. As of the conversion date of March 17, 2021, the conversion rate had not been reset from the initial conversion rate.

The Company evaluated the accounting for the issuance of the December 2019 Bonds and concluded that the embedded conversion feature does not require bifurcation from the December 2019 Bonds. Although the embedded conversion feature meets the definition of a derivative, it qualifies for the equity scope exception for instruments that are both indexed to an entity’s own stock and classified in stockholders’ equity in its consolidated balance sheet. The December 2019 Bonds were denominated in a foreign currency other than the Company’s functional currency, which would typically violate the settlement provision criteria when analyzing whether the conversion option is indexed to an entity’s own stock. However, per the terms of the agreement, the functional currency rate required to be used in a conversion scenario was fixed as of the date preceding the date of issuance of the Bonds. Therefore, the fluctuation in functional currency did not impact the settlement of the conversion option. Further, as there was no cash conversion feature or beneficial conversion feature on the date of issuance, and the Bonds were not issued at a substantial premium, all of the proceeds were recorded as a liability.

The Company determined that all other features of the December 2019 Bonds were clearly and closely associated with a debt host and did not require bifurcation as a derivative liability, or the fair value of the feature was immaterial to the Company's condensed consolidated financial statements.

At their issuance, the Company determined that the expected life of the December 2019 Bonds was equal to the period through December 31, 2022 as this represented the point at which the December 2019 Bonds were initially subject to repurchase by the Company at the option of the holders. The effective interest rate of the December 2019 Bonds was 6.2%. For the six months ended June 30, 2021, the Company recognized $50,000 of interest expense related to the December 2019 Bonds, of which $9,000 related to the contractual interest coupon. For the three and six months ended June 30, 2020, the Company recognized $60,000 and $122,000, respectively, of interest expense related to the December 2019 Bonds, of which $10,000 and $20,000, respectively, related to the contractual interest coupon.

As of June 30, 2021, all outstanding December 2019 Bonds were converted into 1,009,450 shares of the Company's common stock. Upon conversion, the $4.4 million carrying value of the December 2019 Bonds was reclassified to stockholders' equity.

10. Stockholders’ Equity

The following is a summary of the Company's authorized and issued common and preferred stock as of June 30, 2021 and December 31, 2020:


			Outstanding as of
	Authorized	Issued	June 30, 2021	December 31, 2020
Common Stock, par value $0.001 per share	600,000,000	210,146,880	210,146,880	186,851,493


Series C Preferred Stock, par value $0.001 per share	1,091	1,091	9	9

Preferred Stock

In June 2020, 14 shares of the Company’s Series C preferred stock were converted into an aggregate of 5,147 shares of the Company’s common stock.

Common Stock

On January 25, 2021, the Company closed an underwritten public offering of 20,355,000 shares of common stock at a public offering price of $8.50 per share. The net proceeds to the Company, after deducting the underwriters' discounts and commissions and other estimated offering expenses, were $162.1 million.

In May 2018, the Company entered into a Sales Agreement with an outside placement agent (the “Placement Agent”) to sell shares of its common stock with aggregate gross proceeds of up to $100.0 million, from time to time, through an “at-the-market” equity offering program under which the Placement Agent acted as sales agent. During the first quarter of 2020, the Company and the Placement Agent entered into a first and second amendment to the Sales Agreement (the "Prior Sales Agreement") to increase the amount of common stock that may be sold under the Sales Agreement from $100.0 million to $250.0 million. As of March 31, 2020, there was no remaining capacity under the Prior Sales Agreement. On April 3, 2020, the Company and the Placement Agent entered into a new Sales Agreement (the "New Sales Agreement") to sell shares of its common stock. On April 3, 2020 and May 12, 2020, the Company filed prospectus supplements pursuant to the New Sales Agreement for the offer and sale of its Common Stock for aggregate gross proceeds of up to an aggregate of $250.0 million.

During the three months ended March 31, 2020, the Company sold 43,148,952 shares of its common stock under the Prior Sales Agreement. The sales were made at a weighted average price of $4.92 per share, resulting in aggregate net proceeds of $208.2 million. As of March 31, 2020, there was no remaining capacity under the Prior Sales Agreement.

During the year ended December 31, 2020, the Company sold a total of 22,919,934 shares of its common stock under the New Sales Agreement. The sales were made at a weighted average price of $10.91 per share resulting in aggregate net proceeds of $246.2 million. As of December 31, 2020, there was no remaining capacity under the New Sales Agreement.

Stock Options and Restricted Stock Units

The Company has a stock-based incentive plan, the 2016 Omnibus Incentive Plan (as amended to date, the "2016 Incentive Plan"), pursuant to which the Company may grant stock options, restricted stock awards, restricted stock units and other stock-based awards or short-term cash incentive awards to employees, directors and consultants.

The 2016 Incentive Plan was originally approved by the Company's stockholders on May 13, 2016, and an amendment to the plan to increase the number of shares available for issuance was approved by the stockholders on May 8, 2019. As of June 30, 2021, the maximum number of shares of the Company’s common stock available for issuance over the term of the

2016 Incentive Plan was 20,000,000 shares. On the first business day of each calendar year, such maximum number of shares is further increased by 2,000,000 shares of common stock unless the Board determines, prior to January 1 for any such calendar year, to increase such maximum amount by a fewer number of shares or not to increase the maximum amount at all for such year. On January 1, 2021, the maximum number of shares increased by 2,000,000. At June 30, 2021, the Company had 4,998,253 shares of common stock available for future grant under the 2016 Incentive Plan, 2,516,102 shares underlying outstanding but unvested restricted stock units and options outstanding to purchase 7,814,677 shares of common stock under the 2016 Incentive Plan. The awards granted and available for future grant under the 2016 Incentive Plan generally vest over three years and have a maximum contractual term of ten years. The 2016 Incentive Plan terminates by its terms on March 9, 2026.

The Amended and Restated 2007 Omnibus Incentive Plan (the "2007 Incentive Plan") was adopted on March 31, 2007 and terminated by its terms on March 31, 2017. At June 30, 2021, the Company had options outstanding to purchase 2,516,141 shares of common stock under the 2007 Incentive Plan. The awards granted under the 2007 Incentive Plan generally vest over three years and have a maximum contractual term of ten years.

11. Net Loss Per Share

Basic net loss per share is computed by dividing the net loss for the period by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share is calculated in accordance with the treasury stock method for the outstanding stock options and restricted stock units and reflects the potential dilution that would occur if securities or other contracts to issue common stock were exercised or converted to common stock. The dilutive impact of the outstanding Notes and Bonds issued by the Company (discussed in Note 9) has been considered using the "if-converted" method. The calculation of diluted net loss per share requires that, to the extent the average market price of the underlying shares for the reporting period exceeds the exercise price of the options or other securities and the presumed exercise of such securities are dilutive to net loss per share for the period, an adjustment to the net loss used in the calculation is required to remove the change in fair value of such securities from the numerator for the period. Likewise, an adjustment to the denominator is required to reflect the related dilutive shares, if any. For the three and six months ended June 30, 2021 and 2020, basic and diluted net loss per share were the same, as the assumed exercise or settlement of stock options and restricted stock units and the potentially dilutive shares issuable upon conversion of the Notes and Bonds would have been anti-dilutive.

The following table summarizes potential shares of common stock that were excluded from the diluted net loss per share calculation because of their anti-dilutive effect for the three and six months ended June 30, 2021 and 2020:



Common Stock Equivalents	2021	2020
Options to purchase common stock	10,330,818	9,193,096
Service-based restricted stock units	2,516,102	2,868,665
Performance-based restricted stock units	663,353	—
Convertible preferred stock	3,309	3,309
Convertible notes	3,049,980	14,585,653
August 2019 Bonds	—	4,962,364
December 2019 Bonds	—	1,009,450
Total	16,563,562	32,622,537

12. Stock-Based Compensation

The Company incurs stock-based compensation expense related to restricted stock units ("RSUs") and stock options. The fair value of restricted stock is determined by the closing price of the Company's common stock reported on the Nasdaq Global Select Market on the date of grant. The Company estimates the fair value of stock options granted using the Black-Scholes option pricing model. The Black-Scholes option pricing model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of subjective assumptions, including the expected stock price volatility and expected option life. The Company amortizes the fair value of the awards on a straight-line basis over the requisite vesting period of the awards. Expected volatility is based on historical volatility. The expected life of options granted is based on historical expected life. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant. The dividend yield is based on the fact that no dividends have been paid historically and none are currently expected to be paid in the foreseeable future. The Company recognizes forfeitures as they occur.

The weighted average assumptions used in the Black-Scholes model for option grants to employees and directors are presented below:


	Three Months Ended June 30,		Six Months Ended June 30,
	2021	2020	2021	2020
Risk-free interest rate	0.99%	0.40%	0.90%	0.67%
Expected volatility	93%	80%	92%	77%
Expected life in years	5.7	5.9	5.8	5.9
Dividend yield	—	—	—	—

Total employee and director stock-based compensation expense recognized in the condensed consolidated statements of operations for the three and six months ended June 30, 2021 was $5.3 million and $14.5 million, respectively, of which $2.7 million and $7.9 million, respectively, was included in research and development expenses, and $2.6 million and $6.6 million, respectively, was included in general and administrative expenses.

Total employee and director stock-based compensation expense recognized in the condensed consolidated statements of operations for the three and six months ended June 30, 2020 was $3.4 million and $7.1 million, respectively, of which $1.8 million and $4.1 million, respectively, was included in research and development expenses, and $1.6 million and $3.0 million, respectively, was included in general and administrative expenses.

At June 30, 2021, there was $19.8 million of total unrecognized compensation expense related to unvested stock options, which is expected to be recognized over a weighted-average period of 2.3 years.

The weighted average grant date fair value per share, calculated using the Black-Scholes option pricing model, was $5.25 and $7.91 for employee and director stock options granted during the three and six months ended June 30, 2021, respectively, and $9.52 and $6.19 for the three and six months ended June 30, 2020, respectively.

At June 30, 2021, there was $16.8 million of total unrecognized compensation expense related to unvested service-based RSUs, which is expected to be recognized over a weighted-average period of 2.1 years.

The weighted average grant date fair value per share was $6.81 and $10.64 for service-based RSUs granted during the three and six months ended June 30, 2021, respectively, and $14.50 and $9.12 for the three and six months ended June 30, 2020, respectively.

The fair value of stock options granted to non-employees was estimated using the Black-Scholes pricing model. Total stock-based compensation expense for stock options and RSUs granted to non-employees for the three and six months ended June 30, 2021 was $308,000 and $737,000, respectively. Total stock-based compensation expense for stock options and RSUs granted to non-employees for the three and six months ended June 30, 2020 was $224,000 and $607,000, respectively.

On August 28, 2020, the Company granted 663,353 performance-based RSUs to executives under the 2016 Incentive Plan. The RSUs will vest in two tranches as follows: 50% of the shares in each tranche will vest upon achievement of the predetermined performance milestones and the remaining 50% of the shares in each tranche will vest upon subsequent completion of a one-year service period. The total grant date fair value of the performance-based RSUs was $8.0 million based on the grant date closing price per share of $12.06. As of June 30, 2021, the underlying performance milestones of the RSUs were not probable of achievement, and no stock-based compensation expense was recognized for the performance-based RSUs for the six months then ended.

13. Related Party Transactions

Plumbline Life Sciences, Inc.

The Company owned 597,808 shares of common stock in PLS as of June 30, 2021, representing a 19.7% ownership interest, and one of the Company's directors, Dr. David B. Weiner, acts as a consultant to PLS.

Revenue recognized from PLS consists of milestone, license and patent fees. For the three and six months ended June 30, 2021, the Company recognized revenue from PLS of $75,000 and $125,000, respectively, and $64,000 and $1.2 million, for the three and six months ended June 30, 2020, respectively. At June 30, 2021 and December 31, 2020, the Company had an accounts receivable balance of $99,000 and $67,000, respectively, related to PLS.

The Wistar Institute

The Company's director Dr. David B. Weiner is a director of the Vaccine Center of The Wistar Institute ("Wistar"). Dr. Weiner is also the Executive Vice President of Wistar.

In March 2016, the Company entered into collaborative research agreements with Wistar for preventive and therapeutic DNA-based immunotherapy applications and products developed by Dr. Weiner and Wistar for the treatment of cancers and infectious diseases. Under the terms of the agreement, the Company reimbursed Wistar for all direct and indirect costs incurred in the conduct of the collaborative research, not to exceed $3.1 million during the five-year term of the agreements. In March 2021, upon expiration of the March 2016 agreements, the Company entered into new collaborative research agreements with Wistar with the same terms. The Company has the exclusive right to in-license new intellectual property developed under the agreements.

In November 2016, the Company received a $6.1 million sub-grant through Wistar to develop a dMAb against the Zika infection, with funding extended through December 2021.

The Company is also a collaborator with Wistar on an Integrated Preclinical/Clinical AIDS Vaccine Development grant from the NIAID, with funding through February 2022.

In 2020, the Company received a $10.7 million sub-grant through Wistar for the preclinical development and translational studies of dMAbs as countermeasures for COVID-19, with funding through September 2022. The sub-grant also includes an option for an additional $6.0 million in funding through September 2024.

Deferred grant funding recognized from Wistar and recorded as contra-research and development expense is related to work performed by the Company on the research sub-contract agreements. For the three and six months ended June 30, 2021, the Company recorded $381,000 and $610,000, respectively, and for the three and six months ended June 30, 2020 the Company recorded $73,000 and $691,000, respectively, as contra-research and development expense from Wistar.

Research and development expenses recorded from Wistar relate primarily to the collaborative research agreements and sub-contract agreements related to the Bill & Melinda Gates Foundation and CEPI (see Note 15). Research and development expenses recorded from Wistar for the three and six months ended June 30, 2021 were $1.2 million and $1.6 million, respectively. Research and development expenses recorded from Wistar for the three and six months ended June 30, 2020 were $408,000 and $770,000, respectively. At June 30, 2021 and December 31, 2020, the Company had an accounts receivable balance of $617,000 and $425,000, respectively, and an accounts payable and accrued liability balance of $1.8 million and $643,000, respectively, related to Wistar. As of June 30, 2021, the Company had a prepaid expense balance of $303,000 and recorded $69,000 as deferred grant funding on the condensed consolidated balance sheet related to Wistar.

14. Leases

The Company leases approximately 82,200 square feet of office, laboratory, and manufacturing space in San Diego, California and 57,360 square feet of office space in Plymouth Meeting, Pennsylvania under various non-cancellable operating lease agreements with remaining lease terms as of June 30, 2021 of 2.4 to 8.5 years, which represent the non-cancellable periods of the leases. The Company has excluded the extension options from its lease terms in the calculation of future lease payments as they are not reasonably certain to be exercised. The Company's lease payments consist primarily of fixed rental payments for the right to use the underlying leased assets over the lease terms as well as payments for common area maintenance and administrative services. The Company has received customary incentives from its landlords, such as reimbursements for tenant improvements and rent abatement periods, which effectively reduce the total lease payments owed for these leases.

The Company performed an evaluation of its contracts with customers and suppliers in accordance with ASC Topic 842 and determined that, except for the real estate leases described above and various copier leases, none of its other contracts contain a right-of-use asset.

Operating lease right-of-use assets and liabilities on the condensed consolidated balance sheet represents the present value of the remaining lease payments over the remaining lease terms. Payments for additional monthly fees to cover the Company's share of certain facility expenses are not included in operating lease right-of-use assets and liabilities. The Company uses its incremental borrowing rate to calculate the present value of its lease payments, as the implicit rates in the leases are not readily determinable.

As of June 30, 2021, the maturities of the Company's operating lease liabilities were as follows:


Remainder of 2021	$	1,994,000
2022	4,045,000
2023	4,023,000
2024	3,001,000
2025	3,063,000
Thereafter	9,888,000
Total remaining lease payments	26,014,000
Less: present value adjustment	(6,753,000)
Total operating lease liabilities	19,261,000
Less: current portion	(2,464,000)
Long-term operating lease liabilities	$	16,797,000

Weighted-average remaining lease term	7.0 years
Weighted-average discount rate	8.5%

Lease costs included in operating expenses in the condensed consolidated statements of operations for the three and six months ended June 30, 2021 were $827,000 and $1.7 million, respectively. Lease costs included in operating expenses in the condensed consolidated statements of operations for the three and six months ended June 30, 2020 were $814,000 and $1.7 million, respectively. Operating lease costs consisting of the fixed lease payments included in operating lease liabilities are recorded on a straight-line basis over the lease terms. Variable lease costs are recorded as incurred.

In the fourth quarter of 2019, the Company entered into two agreements to sublease a total of approximately 13,500 square feet in its Plymouth Meeting headquarters through periods between December 31, 2022 and March 31, 2025.

In the normal course of business, the Company is a party to a variety of agreements pursuant to which it may be obligated to indemnify the other party. It is not possible to predict the maximum potential amount of future payments under these types of agreements due to the conditional nature of the Company's obligations and the unique facts and circumstances involved in each particular agreement. Historically, payments made by the Company under these types of agreements have not had a material effect on its business, consolidated results of operations or financial condition.

15. Collaborative Agreements

Advaccine Biopharmaceuticals Suzhou Co., Ltd.

On December 31, 2020, the Company entered into a Collaboration and License Agreement with Advaccine Biopharmaceuticals Suzhou Co., Ltd. (“Advaccine”), which was amended and restated on June 7, 2021 (as amended and restated, the “Advaccine Agreement”). Under the terms of the Advaccine Agreement, the Company granted to Advaccine the exclusive right to develop, manufacture and commercialize the Company’s vaccine candidate INO-4800 within the territories of China, Taiwan, Hong Kong and Macau (referred to collectively as “Greater China”) and 33 additional countries in Asia. Advaccine does not have the right to grant sublicenses, other than to affiliated entities, without the Company’s express prior written consent. As part of the collaboration, Advaccine also granted to the Company a non-exclusive license to certain DNA vaccine manufacturing processes.

The June 2021 amendment relates to the collaboration between the Company and Advaccine to jointly conduct the global Phase 3 segment of the Company’s ongoing Phase 2/3 trial of INO-4800 and expand the existing collaboration to include the planned global Phase 3 trial. The parties will jointly participate in the trial and will equally share the global development costs for the trial, including the Company’s manufacturing costs to supply INO-4800. In certain instances, the Company will have the right to convert the exclusive license to a non-exclusive license in the licensed territories, other than Greater China, unless Advaccine agrees to pay the Company its full share of development costs in excess of a specified maximum. Notwithstanding the foregoing, Advaccine will be fully responsible for conducting the trial in Greater China, including its costs and expenses incurred in conducting the trial in Greater China. The Company will be fully responsible for its costs and expenses, if any, incurred solely as a result of its activities in connection with the performance of the trial in the United States. The parties may continue to conduct clinical trials of INO-4800 outside of the territories covered by the Advaccine Agreement.

In the event that a global purchasing entity desires to enter into a purchase agreement for INO-4800 in both parties’ territories, the parties will enter into good faith negotiations for an arrangement to supply INO-4800 to such entity. In addition, the Company is permitted to enter into an agreement with a global purchasing entity to authorize the entity to conduct a portion of the global Phase 3 trial in the licensed territory outside of Greater China.

Under the Advaccine Agreement, Advaccine made an upfront payment to the Company of $3.0 million in January 2021. In addition to the upfront payment, the Company is entitled to receive up to an aggregate of $206.0 million upon the achievement of specified milestones related to the development, regulatory approval and commercialization of INO-4800, including the achievement of specified net sales thresholds for INO-4800 in Greater China and the additional covered territories, if approved. As of December 31, 2020 the Company had earned a $2.0 million milestone payment based on the enrollment of the first subject in the Phase 2 clinical trial for the product in the Advaccine territory. The Company will also be entitled to receive a royalty equal to a high single-digit percentage of annual net sales in each region within the licensed territory, subject to reduction in the event of competition from biosimilar products in a particular region and in other specified circumstances. Advaccine’s obligation to pay royalties will continue, on a licensed product-by-licensed product basis and region-by-region basis, for ten years after the first commercial sale in a particular region within Greater China or, if later, until the expiration of the last-to-expire patent covering a given licensed product in a given region.

Beginning in the first calendar year following the first commercial sale of INO-4800 in the licensed territory outside of Greater China, Advaccine will pay the Company an annual maintenance fee of $1.5 million for a period of five years, which fee will be creditable against any royalties payable by Advaccine with respect to sales outside of Greater China.

Under the Advaccine Agreement, the Company will supply Advaccine’s clinical requirements of INO-4800 and devices, although Advaccine may manufacture INO-4800 for its clinical use and may procure alternate suppliers. Advaccine is responsible for the manufacture and supply of INO-4800 itself or through a contract manufacturer for commercial use. Upon Advaccine’s reasonable request, the parties may negotiate a separate clinical and/or commercial supply agreement.

The Advaccine Agreement will continue in force on a region-by-region basis until Advaccine has no remaining royalty obligations in such region. Either party may terminate the Advaccine Agreement (i) in the event the other party shall have materially breached its obligations thereunder and such default shall have continued for a specified period after written notice thereof or (ii) upon the bankruptcy or insolvency of the other party. In addition, the Company may terminate the agreement, upon prior written notice, if Advaccine (i) ceases all development or commercialization activities for at least nine months, subject to certain exceptions, or (ii) challenges the validity, enforceability or scope of any of the patents licensed by the Company to Advaccine under the Advaccine Agreement, subject to certain conditions. Advaccine may terminate the Advaccine Agreement at any time for convenience upon nine months’ written notice to the Company, if such notice is provided before the first commercial sale of INO-4800 in the licensed territory, or 18 months’ written notice thereafter; provided that the Company may accelerate the effectiveness of such termination to the extent permitted by law.

The Company evaluated the terms of the Advaccine Agreement under ASC Topics 606 and 808 at inception and determined that the contract was with a customer and therefore should be accounted for under ASC Topic 606. The license to INO-4800 in the territories was identified as the only distinct performance obligation on a standalone basis as of the inception of the Advaccine Agreement. The Company concluded that the license was distinct from potential future manufacturing and supply obligations. The Company further determined that the transaction price under the Advaccine Agreement consisted of the $3.0 million upfront payment plus the initial $2.0 million milestone payment which was achieved upon contract signing. The future potential milestone amounts were not included in the transaction price, as they were all determined to be fully constrained. As part of the evaluation of the development and regulatory milestones constraint, the Company determined that the achievement of such milestones is contingent upon success in future clinical trials and regulatory approvals, each of which is uncertain. Future potential milestone amounts may be recognized as revenue under the Advaccine Agreement, as well as under other collaborative research and development arrangements, if unconstrained. Reimbursable program costs will be recognized proportionately with the performance of the underlying services or delivery of drug supply and are excluded from the transaction price.

Under Topic 606, the entire transaction price of $5.0 million was allocated to the license performance obligation. The Company determined that as of December 31, 2020, the transfer of technology has occurred for the use and benefit of the license and accordingly, the performance obligation was fully satisfied. The Company accordingly recognized $5.0 million in revenue under collaborative research and development arrangements on the consolidated statement of operations during the year ended December 31, 2020. For the six months ended June 30, 2021, no revenue was recognized from Advaccine. As of June 30, 2021 and December 31, 2020, the Company had an accounts receivable balance of $0 and $7.1 million, respectively, from Advaccine.

The Company reevaluated the Advaccine Agreement under ASC Topics 606 and 808 as of the date of the June 2021 amendments and determined that the Global Phase 3 trial component of the agreement is a collaboration and not a contract with a customer and therefore should be accounted for under ASC Topic 808. Reimbursements from Advaccine will be recognized as contra-research development expense on the condensed consolidated statement of operations once earned and collectibility is assured. As of June 30, 2021, no contra-research and development expense has been recorded from Advaccine.

ApolloBio Corporation

On December 29, 2017, the Company entered into an Amended and Restated License and Collaboration Agreement (the

"ApolloBio Agreement"), with ApolloBio Corporation ("ApolloBio"), with an effective date of March 20, 2018. Under the terms of the ApolloBio Agreement, the Company has granted to ApolloBio the exclusive right to develop and commercialize VGX-3100, its DNA immunotherapy product candidate designed to treat pre-cancers caused by HPV, within the territories of China, Hong Kong, Macao, Taiwan, and potentially Korea in the event that no patent covering VGX-3100 is issued in China within the three years following the effective date of the ApolloBio Agreement.

Under the ApolloBio Agreement, the Company received proceeds of $19.4 million in March 2018 which comprised the upfront payment of $23.0 million less $2.2 million in foreign income taxes and $1.4 million in certain foreign non-income taxes. The foreign income taxes were recorded as a provision for income taxes and the foreign non-income taxes were recorded as a general and administrative expense, on the condensed consolidated statement of operations. The Company also incurred advisory fees of $960,000 in connection with receiving the upfront payment from ApolloBio. These fees were determined to be incremental costs of obtaining the contract. The Company applied the practical expedient that permits a company to expense incremental costs to obtain a contract when the expected amortization period is one year or less and recorded the fees in general and administrative expense during the quarter ended March 31, 2018. No additional advisory fees are due related to the ApolloBio Agreement.

In addition to the upfront payment, the Company is entitled to receive up to an aggregate of $20.0 million, less required income, withholding or other taxes, upon the achievement of specified milestones related to the regulatory approval of VGX-3100 in the United States, China and Korea. In the event that VGX-3100 is approved for marketing, the Company will be entitled to receive royalty payments based on a tiered percentage of annual net sales, with such percentage being in the low- to mid-teens, subject to reduction in the event of generic competition in a particular territory. ApolloBio’s obligation to pay royalties will continue for 10 years after the first commercial sale in a particular territory or, if later, until the expiration of the last-to-expire patent covering the licensed products in the specified territory.

The ApolloBio Agreement will continue in force until ApolloBio has no remaining royalty obligations. Either party may terminate the ApolloBio Agreement in the event the other party shall materially breach or default in the performance of its material obligations thereunder and such default continues for a specified period after written notice thereof. In addition, ApolloBio may terminate the ApolloBio Agreement at any time beginning one year after the effective date for any reason upon 90 days written notice to the Company.

The Company evaluated the terms of the ApolloBio Agreement under ASC Topic 606, and the license to VGX-3100 in the territories was identified as the only distinct performance obligation on a standalone basis as of the inception of the agreement. The Company concluded that the license was distinct from potential future manufacturing and supply obligations. The Company further determined that the transaction price under the agreement consisted of the $23.0 million upfront payment. The future potential milestone amounts were not included in the transaction price, as they were all determined to be fully constrained. As part of the evaluation of the development and regulatory milestones constraint, the Company determined that the achievement of such milestones is contingent upon success in future clinical trials and regulatory approvals, each of which is uncertain at this time. Future potential milestone amounts may be recognized as revenue under the ApolloBio Agreement, as well as under other collaborative research and development arrangements, if unconstrained. Reimbursable program costs will be recognized proportionately with the performance of the underlying services or delivery of drug supply and are excluded from the transaction price. As of June 30, 2021 there have been no significant reimbursable program costs under the ApolloBio Agreement.

Under Topic 606, the entire transaction price of $23.0 million was allocated to the license performance obligation. The Company determined that during the quarter ended June 30, 2018, the transfer of technology occurred and accordingly, the performance obligation was fully satisfied.

AstraZeneca

On August 7, 2015, the Company entered into a license and collaboration agreement with MedImmune, the global biologics research and development arm of AstraZeneca ("AstraZeneca"). Under the agreement, AstraZeneca acquired exclusive rights to the Company's INO-3112 immunotherapy, renamed as MEDI0457, which targets cancers caused by human papillomavirus (HPV) types 16 and 18, with the ability to sublicense those license rights. AstraZeneca made an upfront payment of $27.5 million to the Company in September 2015. AstraZeneca may be obligated to make potential future development and regulatory event-based payments to the Company totaling up to $125 million and potential future commercial event-based payments totaling up to $115 million, in each case upon the achievement of specified milestones related to MEDI0457 set forth in the license and collaboration agreement. AstraZeneca will fund all development costs associated with MEDI0457 immunotherapy. The Company is entitled to receive up to mid-single to double-digit tiered royalties on MEDI0457 product sales. Under the agreement, AstraZeneca can also request the Company to provide certain clinical manufacturing at an agreed upon price. The Company determined these options did not represent material rights at the inception of the agreement.

As of December 31, 2017, the Company had recognized all of the $27.5 million upfront payment as revenue, as all identified material performance obligations had been met with respect to that payment. In both December 2018 and March

2019, the Company recognized as revenue $2.0 million in milestone payments from AstraZeneca triggered by AstraZeneca’s initiation of the Phase 2 portion of ongoing clinical trials in the second and third major indication, respectively, under the agreement.

Coalition for Epidemic Preparedness Innovations

In April 2018, the Company entered into agreements with CEPI, pursuant to which the Company intends to develop vaccine candidates against Lassa fever and MERS. The goal of the collaboration between the Company and CEPI is to conduct research and development so that investigational stockpiles will be ready for clinical efficacy trial testing during potential disease outbreaks. The agreements with CEPI contemplate preclinical studies, as well as Phase 1 and Phase 2 clinical trials, occurring over multiple years. As part of the arrangement between the parties, CEPI has agreed to fund up to an aggregate of $56 million of costs over a five-year period for preclinical studies, as well as planned Phase 1 and Phase 2 clinical trials, to be conducted by the Company and collaborators, with funding from CEPI based on the achievement of identified milestones. During the three and six months ended June 30, 2021, the Company received funding of $2.1 million and $4.4 million, respectively, related to these grants and recorded those payments as contra-research and development expense. During the three and six months ended June 30, 2020, the Company received funding of $1.8 million and $2.9 million, respectively, related to these grants and recorded those payments as contra-research and development expense. As of June 30, 2021, the Company had $316,000 recorded as grant funding liability on the condensed consolidated balance sheet related to these CEPI grants.

In January 2020, CEPI awarded the Company a grant of up to $9.0 million to support preclinical and clinical development of INO-4800 through Phase 1 human testing in the United States. In April 2020, CEPI awarded the Company a grant of $6.9 million to work with the International Vaccine Institute ("IVI") and the Korea National Institute of Health ("KNIH") to conduct clinical trials of INO-4800 in South Korea, a grant of $5.0 million to accelerate development of the Company's next-generation intradermal electroporation device, known as CELLECTRA® 3PSP, for the intradermal delivery of INO-4800, and a grant of $1.3 million to support large-scale manufacturing of INO-4800. During the three and six months ended June 30, 2021, the Company received funding of $1.1 million and $3.5 million, respectively, from CEPI related to these grants for INO-4800 and recorded such amounts as contra-research and development expense. During the three and six months ended June 30, 2020, the Company received funding of $5.8 million and $8.1 million, respectively, from CEPI related to these grants for INO-4800 and recorded such amounts as contra-research and development expense. As of June 30, 2021, the Company had $2.9 million recorded as deferred grant funding on the condensed consolidated balance sheet from the CEPI grants related to INO-4800.

Bill & Melinda Gates Foundation

In October 2018, the Bill & Melinda Gates Foundation (“Gates”) awarded and funded the Company a grant of $2.2 million to advance the development of dMAbs to address issues in infectious disease prevention and therapy. This technology has high relevance for the control of influenza and HIV. This next-generation approach to the delivery of monoclonal antibodies would make the technology accessible to low and middle-income countries. In August 2019, Gates funded an additional $1.1 million for the project. During the three and six months ended June 30, 2020, the Company recorded $36,000 and $170,000, respectively, as contra-research and development expense related to the Gates dMAb grant. During the three and six months ended June 30, 2021, the amounts recorded were minimal. As of June 30, 2021, the Company had $575,000 recorded as deferred grant funding on the condensed consolidated balance sheet related to the grant.

In March 2020, Gates awarded and funded the Company a grant of $5.0 million to accelerate the development of the CELLECTRA® 3PSP device for the intradermal delivery of INO-4800. During the three and six months ended June 30, 2021, the Company recorded $0 and $893,000, respectively, and during the three and six months ended June 30, 2020 recorded $850,000 and $913,000, respectively, as contra-research and development expense related to this Gates grant.

Department of Defense (DoD)

In June 2020, the Company entered into an Other Transaction Authority for Prototype Agreement (the “OTA Agreement”) with the DoD to fund the Company’s efforts in developing the CELLECTRA® 3PSP device and associated arrays to be used for delivery of INO-4800 against COVID-19. Under the OTA Agreement, the Company intends to develop the CELLECTRA® 3PSP device and arrays for use in the U.S. military population and the U.S. population as a whole, subject to approval of the device by the U.S. Food and Drug Administration (the “FDA”). The OTA Agreement is also expected to support large-scale manufacturing of the CELLECTRA® 3PSP device, as well as large-scale DNA plasmid production for manufacture and supply of a specified number of doses of INO-4800 in support of FDA approval of the device. The total amount of funding being made available to the Company under the OTA Agreement is approximately $54.5 million. The Company has determined that the OTA Agreement should be considered under Subtopic 958-605, Not-for-Profit Entities Revenue Recognition, which is outside the scope of Topic 606, as the government agency granting the Company funds is not receiving reciprocal value for their contributions. The Company will record contra-research development expense on the condensed consolidated statement of operations in the same period that the underlying expenses are incurred.

Additionally, in June 2020, the Company was awarded a fixed-price contract (the “Procurement Contract”) from the DoD for the purchase of the Company’s intradermal CELLECTRA® 2000 device and accessories. The CELLECTRA® 2000

devices will be used to inject INO-4800 in the Company’s planned later-stage clinical trials. The total purchase price under the Procurement Contract is approximately $16.6 million. The Company has determined that the Procurement Contract does not currently fall under the scope of ASC 606 as contingencies remain regarding INO-4800 which does not give the Company the ability to satisfy its obligations under the arrangement.

During the three and six months ended June 30, 2021, the Company recorded $13.4 million and $21.2 million, respectively, as contra-research and development expense related to the OTA Agreement. During the three and six months ended June 30, 2020, there was no contra-research and development expense recorded related to the OTA Agreement. As of June 30, 2021 and December 31, 2020, the Company had an accounts receivable balance of $12.9 million and $11.4 million, respectively, on the condensed consolidated balance sheet from the DoD. As of June 30, 2021, the Company had $3.0 million recorded as deferred grant funding on the condensed consolidated balance sheet related to the Procurement Contract.

In April 2021, the Company announced that the DoD had notified the Company that it will discontinue funding for the Phase 3 segment of the Company's clinical trial of INO-4800 in the United States, while continuing to fund the completion of the ongoing Phase 2 segment.

16. Income Taxes

The Company uses an estimated annual effective tax rate, which is based on expected annual income, statutory tax rates and tax planning opportunities available in the various jurisdictions in which the Company operates, to determine its quarterly provision for income taxes. Certain significant or unusual items are separately recognized in the quarter in which they occur and can be a source of variability in the effective tax rates from quarter to quarter. Due to the adoption of ASU 2019-12 which removes the exception under ASC 740-20-45-7 to consider all sources of income in order to determine the tax benefit resulting from a loss from continuing operations, ASC 740-20-45-7 no longer applies.

On March 27, 2020, the United States enacted the Coronavirus Aid, Relief and Economic Security Act (CARES Act). The CARES Act is an emergency economic stimulus package that includes spending and tax breaks to strengthen the United States economy and fund a nationwide effort to curtail the effect of COVID-19. The CARES Act provides sweeping tax changes in response to the COVID-19 pandemic; some of the more significant provisions are removal of certain limitations on utilization of net operating losses, increasing the loss carryback period for certain losses to five years, and increasing the ability to deduct interest expense, as well as amending certain provisions of the previously enacted Tax Cuts and Jobs Act. For the three and six months ended June 30, 2021, the Company has not recorded any income tax provision/(benefit) due to the Company’s history of net operating losses generated and the maintenance of a full valuation allowance against its net deferred tax assets.

17. Geneos Therapeutics, Inc.

In August 2016, the Company formed Geneos to develop and commercialize neoantigen-based personalized cancer therapies. Geneos was considered a variable interest entity (VIE) for which the Company was the primary beneficiary. In February 2019, Geneos completed the initial closing of a Series A preferred stock financing. The Company invested $1.2 million in the Series A preferred stock financing, which was led by an outside investor. Following this transaction, the Company held 61% of the outstanding equity, on an as-converted to common stock basis, of Geneos and continued to consolidate its investment in Geneos under ASC 810, Consolidation.

In January 2020, Geneos completed the second closing of the Series A preferred stock financing, in which the Company invested $800,000. Following this transaction, as of March 31, 2020, the Company held 52% of the outstanding equity, on an as-converted to common stock basis, of Geneos and continued to consolidate its investment in Geneos.

In June 2020, Geneos closed an additional Series A preferred stock financing round, in which the Company invested $800,000. Following this transaction, the Company owned 47% of the outstanding equity of Geneos on an as-converted to common stock basis. This transaction triggered a VIE reconsideration, as the Company no longer held a controlling financial interest. Based on the Company’s assessment, Geneos continued to be a VIE as it did not have sufficient equity at risk to finance its activities without additional subordinated financial support. However, the Company was not the primary beneficiary of Geneos, as it did not have the power to direct the activities that most significantly impact Geneos’ economic performance. Accordingly, the Company deconsolidated its investment in Geneos as of June 1, 2020, resulting in a gain of $4.1 million, of which $2.4 million related to the remeasurement of the retained noncontrolling interest investment to fair value. The gain has been recorded separately on the Company's condensed consolidated statement of operations. The following table shows the amounts related to the deconsolidation accounting:


Working capital (excluding cash)	$	(59,992)
Note payable	171,620
Fixed assets, net of accumulated depreciation	(16,340)
Carrying value of noncontrolling interest	3,181,640
Fair value of investment in Geneos retained	3,618,998
Gain on deconsolidation of Geneos	(4,121,075)
Decrease in cash resulting from the deconsolidation of Geneos	$	2,774,851

The details of the Company’s 47% retained equity investment in Geneos is shown in the table below, with fair values calculated as of June 1, 2020, the date of deconsolidation.


Geneos Share Class	Shares	Price per Share		Fair Value
Common	3,000,000	$	0.273	$	819,000
Preferred	2,113,206	$	1.325	$	2,799,998
Total	5,113,206			$	3,618,998

The fair value of Geneos Series A preferred stock was based on the per share price paid by third-party investors in connection with the most recent closing of the Series A preferred stock financing for Geneos on June 1, 2020. The fair value of Geneos common stock was determined by a third-party valuation, as there is no public market for such stock. Geneos’ enterprise value, which was estimated using a market approach that derived an implied total equity value from a transaction involving its own securities, was allocated to all classes of equity using the option pricing method. Under the option pricing method, each equity class was modeled as having a call option with a distinct claim on the total value of Geneos. Each option’s exercise price was based on the total value available for each participating security holder. The characteristics of each class of ownership determined the claim on the total value for that class of ownership.

The estimated value allocated to common stock included assumptions related to the fair value of the enterprise, expected volatility, expected term, and risk-free interest rate. Expected volatility was based on historical asset volatilities derived from daily stock price changes of guideline public companies. The estimated expected term was based on a weighted average of the estimated time to Geneos's next financing and successful exit timing assumption. The risk-free interest rate was based on the yield of U.S. Treasury with a comparable term. Geneos’s common stock is classified as a Level 3 financial instrument. The assumptions used in the fair value calculation as of June 1, 2020 are presented below:


Expected term (years)			2.92
Volatility			70%
Risk-free interest rate			2.46%
Geneos enterprise value			$4,966,531

The Company applies the equity method to investments in common stock and to other investments in entities that have risk and reward characteristics that are substantially similar to an investment in the investee’s common stock. Since the Company’s Series A preferred stock investment in Geneos has a substantive liquidation preference, it is not substantially similar to the Company’s common stock investment and will therefore be recorded as an equity security under ASC 321.

As of June 1, 2020, the Company accounts for its common stock investment in Geneos, in which the Company lacks control but does have the ability to exercise significant influence over operating and financial policies, using the equity method. Generally, the ability to exercise significant influence is presumed when the investor possesses more than 20% of the voting interests of the investee. This presumption may be overcome based on specific facts and circumstances that demonstrate that the ability to exercise significant influence is restricted. In applying the equity method, the Company records the investment at cost unless the initial recognition is the result of the deconsolidation of a subsidiary, in which case it is recorded at fair value. The Company's proportionate share of net loss of Geneos is recorded in equity in net earnings of Geneos in the Company's condensed consolidated statements of operations. The Company's equity method investments are reviewed for indicators of impairment at each reporting period and are written down to fair value if there is evidence of a loss in value that is other-than-temporary. Any difference between the carrying amount of the Company’s investment and the amount of underlying equity in Geneos’ net assets is amortized into income or expense accordingly. There were no basis differences identified as of the deconsolidation date that would need to be amortized.

Upon deconsolidation, the Company recorded its Series A preferred stock investment at fair value based on the per share price paid by third party investors in connection with the preferred stock financing on June 1, 2020. The Company has determined that its Series A preferred stock investment in Geneos does not have a readily determinable fair value and has

therefore elected the measurement alternative in ASC 321 to subsequently record the investment at cost, less any impairments, plus or minus changes resulting from observable price changes in orderly transactions for identical or similar investments of the same issuer. When fair value becomes determinable, from observable price changes in orderly transactions, the Company’s investment will be marked to fair value. There have been no observable price changes or impairments identified since the deconsolidation date.

In November 2020, Geneos completed the closing of a Series A-1 preferred stock financing. The Company invested $1.4 million in the Series A-1 preferred stock financing, which was led by outside investors. The closing date of this transaction was determined to be a VIE reconsideration event; based on the Company’s assessment, Geneos continues to be a VIE as it does not have sufficient equity at risk to finance its activities without additional subordinated financial support. The Company continues to not be the primary beneficiary of Geneos, as it does not have the power to direct the activities that most significantly impact Geneos’s economic performance and should not consolidate Geneos. Following this transaction, the Company held approximately 36% of the outstanding equity, on an as-converted to common stock basis. Accordingly, the Company continues to account for its common stock investment in Geneos as an equity method investment under ASC 323 and its preferred stock investments as equity securities under ASC 321.

The fair value of Geneos’s Series A-1 preferred stock was based on the per share price paid by third-party investors in connection with the closing on November 12, 2020. The Company has concluded that its Series A-1 preferred stock investment is not similar to its prior Series A preferred stock investment due to certain material rights held solely by Series A preferred stockholders. Therefore, the Company will continue to record its Series A preferred stock investment in Geneos at cost, as there have been no observable price changes or impairments identified since the deconsolidation date.

The Company’s share of net losses of Geneos for the period from June 1, 2020 through December 31, 2020 was $4.6 million and for the three months ended March 31, 2021 was $1.5 million; however, only $434,000 was recorded, reducing the Company's total investment in Geneos to $0. Of the total amount, $819,000 has been allocated to the equity method investment, thereby reducing the balance to $0 as of March 31, 2021. The remaining $4.2 million loss has been allocated to the Company’s Series A and Series A-1 preferred stock investment in Geneos, on a ratable basis, thereby reducing the balance to $0 as of March 31, 2021 as shown in the table below:



Investment in Geneos upon deconsolidation	$	3,618,998
Investment in Geneos Series A-1 preferred stock	1,399,999
Share in net loss of Geneos from June 1, 2020 - December 31, 2020	(4,584,610)
Share in net loss of Geneos for the three months ended March 31, 2021	(434,387)
Investment in Geneos as of March 31, 2021	$	—

The Company will not reduce its investment below $0 and will not record its share of further net losses of Geneos as the Company has no obligation to fund Geneos.

In February 2021, Geneos completed a second closing of the Series A-1 preferred stock financing, in which the Company did not participate. Following this transaction, the Company held approximately 35% of the outstanding equity, on an as-converted to common stock basis.

The Company continues to exclusively license its SynCon® immunotherapy and CELLECTRA® technology platform to Geneos to be used in the field of personalized, neoantigen-based therapy for cancer. The license agreement provides for potential royalty payments to the Company in the event that Geneos commercializes any products using the licensed technology. The Company is not obligated to use any of its assets to fund the future operations of Geneos.

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This Quarterly Report contains forward-looking statements, as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements relate to future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential” or “continue,” the negative of such terms or other comparable terminology. These statements are only predictions. Actual events or results may differ materially.

Although we believe that the expectations reflected in the forward-looking statements are reasonable based on our current expectations and projections, we cannot guarantee future results, levels of activity, performance or achievements. Moreover, neither we, nor any other person, assume responsibility for the accuracy and completeness of the forward-looking statements. We are under no obligation to update any of the forward-looking statements after the filing of this Quarterly Report to conform such statements to actual results or to changes in our expectations.

The following discussion of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the related notes and other financial information appearing elsewhere in this Quarterly Report and our audited consolidated financial statements and related notes for the year ended December 31, 2020 included in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission, or SEC, on March 1, 2021 (our 2020 Annual Report). Readers are also urged to carefully review and consider the various disclosures made by us that attempt to advise interested parties of the factors that affect our business, including without limitation the disclosures made in Item 1A of Part II of this Quarterly Report under the captions “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operations,” and the disclosures made in our 2020 Annual Report under the caption “Risk Factors” and in our audited consolidated financial statements and related notes.

Risk factors that could cause actual results to differ from those contained in the forward-looking statements include but are not limited to: our history of losses; our lack of products that have received regulatory approval; uncertainties inherent in clinical trials and product development programs, including but not limited to the fact that preclinical and clinical results 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 desired results, that preclinical studies and clinical trials may not commence, have sufficient enrollment 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, that results from an animal study may not be indicative of results achievable in human studies, that clinical testing is expensive and can take many years to complete, that the outcome of any clinical trial is uncertain and failure can occur at any time during the clinical trial process, and that our electroporation technology and product candidates may fail to show the desired safety and efficacy traits in clinical trials; the availability of funding; the ability to manufacture our product candidates; the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or our collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that we and our collaborators hope to develop; our ability to receive development, regulatory and commercialization event-based payments under our collaborative agreements; whether our proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity; the impact of government healthcare laws and proposals; and the impact of COVID-19 on us and our third-party contractors and suppliers.

Overview

We are a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with human papillomavirus ("HPV"). Our DNA medicines pipeline is comprised of three types of product candidates: DNA vaccines, DNA immunotherapies and DNA encoded monoclonal antibodies ("dMAbs"). In clinical trials, we have demonstrated that DNA medicines can be delivered directly into cells in the body through our proprietary smart device to consistently activate robust and fully functional T cell and antibody responses against targeted pathogens and cancers.

Our novel DNA medicine candidates are made using our proprietary SynCon® technology that creates optimized plasmids, which are circular strands of DNA that instruct a cell to produce antigens to help the person’s immune system recognize and destroy cancerous or virally infected cells.

Our patented CELLECTRA® smart delivery devices provide optimized uptake of our DNA medicines within the cell, overcoming a key limitation of other DNA-based technology approaches, namely cellular uptake.

Human clinical trial data to date have shown a favorable safety profile of our DNA medicines delivered directly into cells in the body using the CELLECTRA® smart device in more than 7,000 administrations across more than 3,000 patients.

Our corporate strategy is to advance, protect and, once approved, commercialize our novel DNA medicines to meet urgent and emerging global health needs. We continue to advance and clinically validate an array of DNA medicine candidates that target infectious diseases, such as COVID-19, as well as HPV-associated diseases and cancer. We aim to advance these candidates through commercialization and continue to leverage third-party resources through collaborations and partnerships, including product license agreements.

Our partners and collaborators include ApolloBio Corp., AstraZeneca, Advaccine, The Bill & Melinda Gates Foundation (Gates), Coalition for Epidemic Preparedness Innovations ("CEPI"), Defense Advanced Research Projects Agency ("DARPA"), The U.S. Department of Defense ("DoD"), GeneOne Life Science, HIV Vaccines Trial Network, the U.S. Defense Threat Reduction Agency’s Medical CBRN Defense Consortium ("MCDC"), International Vaccine Institute ("IVI"), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron Pharmaceuticals, Richter-Helm BioLogics, Thermo Fisher Scientific, the University of Pennsylvania, the Walter Reed Army Institute of Research, and The Wistar Institute.

We or our collaborators are currently conducting or planning clinical studies of our DNA medicines for COVID-19; Middle East Respiratory Syndrome, or MERS; Lassa fever; HIV; Ebola; as well as HPV-associated precancers, including cervical, vulvar, and anal dysplasia; HPV-associated cancers, including head & neck, cervical, anal, penile, vulvar, and vaginal; other HPV-associated disorders, such as recurrent respiratory papillomatosis, or RRP; glioblastoma multiforme, or GBM; and prostate cancer.

All of our product candidates are in the research and development phase. We have not generated any revenues from the sale of any products, and we do not expect to generate any such revenues for at least the next several years. We earn revenue from license fees and milestone revenue and collaborative research and development agreements. Our product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing. All product candidates that we advance to clinical testing will require regulatory approval prior to commercial use, and will require significant costs for commercialization. We may not be successful in our research and development efforts, and we may never generate sufficient product revenue to be profitable.

As of June 30, 2021, we had an accumulated deficit of $1.0 billion. We expect to continue to incur substantial operating losses in the future due to our commitment to our research and development programs, the funding of preclinical studies, clinical trials and regulatory activities and the costs of general and administrative activities.

Impacts of COVID-19 On Our Business

Operationally, we have experienced some disruptions as a result of the COVID-19 pandemic. Our clinical trial operations have been adversely affected, including our ability to initiate and conduct our planned trials on our expected timelines and our ability to recruit and retain patients in our trials. Our data collection timelines have also been impacted, as an increasing number of trial participants are either not able or do not feel safe going into healthcare facilities, which is necessary for the collection and completion of data samples. As a result, it is taking longer than anticipated to complete the data collection process.

In response to the outbreak, a number of governmental orders and other public health guidance measures were implemented across much of the United States, including in the locations of our offices, laboratories, clinical trial sites and third parties on whom we rely. We have implemented a work from home policy allowing employees who can work from home to do so, while those needing to work in laboratory facilities work in shifts to reduce the number of people gathered together at one time. We have also implemented a mask-wearing mandate for all on-site activities. Non-essential business travel has been suspended, and online and teleconference technology is used to meet virtually rather than in person. We have taken measures to secure our research and development project activities, while work in laboratories has been organized to reduce risk of COVID-19 transmission.

Our liquidity has not been negatively impacted to date by the pandemic. During the year ended December 31, 2020, we raised $454.5 million in net proceeds from the sale of shares of our common stock through our "at-the-market" equity offering program and in January 2021 we closed an underwritten public offering with net proceeds to us of $162.1 million, which further enhanced our liquidity and capital resources. As of June 30, 2021, our cash and cash equivalents and short-term investments were $443.7 million.

We are continuing to closely monitor the impact of the COVID-19 pandemic on our employees, collaborators and service providers. The extent to which the pandemic will impact our business and operations will depend on future developments, including travel restrictions in the United States and other countries, and the effectiveness of actions taken in the United States and other countries to contain and treat the disease, including mass vaccination efforts, that are highly uncertain. For additional information on the potential effects of the COVID-19 pandemic on our business, financial condition and results of operations, see the “Risk Factors” section below in Part II, Item 1A of this Form 10-Q.

Critical Accounting Policies

There have been no significant changes to our critical accounting policies since December 31, 2020. For a description of our critical accounting policies that affect our significant judgments and estimates used in the preparation of our condensed consolidated financial statements, refer to Note 3 to our Condensed Consolidated Financial Statements included in this Quarterly Report, as well as Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2020 Annual Report and Note 2 to our audited Consolidated Financial Statements contained in our 2020 Annual Report.

Adoption of Recent Accounting Pronouncements

Information regarding recent accounting pronouncements is contained in Note 4 to the Condensed Consolidated Financial Statements, included in this Quarterly Report.

Results of Operations

Revenue. Total revenue was $273,000 and $644,000, respectively, for the three and six months ended June 30, 2021, as compared to $267,000 and $1.6 million, respectively, for the three and six months ended June 30, 2020. Revenue primarily consisted of revenues under collaborative research and development arrangements, including arrangements with affiliated entities, for the three and six months ended June 30, 2021 and 2020. The decrease in revenue for the six-month period year over year was primarily due to less milestone revenue earned from our affiliated entity PLS.

Research and development expenses. Research and development expenses for the three and six months ended June 30, 2021 were $70.8 million and $109.9 million, respectively, as compared to $22.4 million and $41.5 million, respectively, for the three and six months ended June 30, 2020. In each case, the significant increase was primarily attributable to manufacturing scale-up activities for INO-4800 in 2021. These INO-4800 activities included:

•expenses related to the acquisition and installation of manufacturing equipment, which increased by $21.9 million for each of the three-month and six-month periods; and

•drug manufacturing, outside services and clinical study expenses, which increased by $16.2 million and $27.9 million for the three-month and six-month periods, respectively.

Other increases for the three-month and six-month periods year over year included:

•$7.9 million and $10.5 million, respectively, in engineering services and expensed equipment related to our CELLECTRA® 3PSP device array automation project;

•$3.5 million and $8.3 million, respectively in employee and contractor compensation;

•$3.0 million and $3.7 million, respectively, in drug manufacturing expenses related to our RRP study; and

•$894,000 and $3.8 million, respectively, in employee stock-based compensation.

These increases were offset by increases in contra-research and development expense recorded from grant agreements of $8.1 million and $16.9 million for the three-month and six-month periods, respectively, among other variances.

Contributions received from current grant agreements and recorded as contra-research and development expense were $17.2 million and $31.0 million, respectively, for the three and six months ended June 30, 2021 as compared to $9.1 million and $14.1 million, respectively, for the three and six months ended June 30, 2020. The increase for the three-month period year over year was primarily due to an increase of $13.4 million earned under the DoD grant, offset by decreases of $4.6 million and $850,000 earned under the grants from CEPI and Gates, respectively, related to INO-4800 and device development activities, among other variances. The increase for the six-month period year over year was primarily due to increases of $21.2 million and $1.5 million earned under the DoD grant and CEPI grants related to our Lassa fever and MERS vaccine candidates, respectively. These increases were offset by decreases of $4.6 million and $1.1 million from our CEPI grants related to INO-4800 and device development and the MCDC grant, respectively, among other variances.

General and administrative expenses. General and administrative expenses, which include business development expenses, the amortization of intangible assets and patent expenses, were $12.7 million and $26.5 million, respectively, for the three and six months ended June 30, 2021, as compared to $11.1 million and $18.5 million, respectively, for the three and six months ended June 30, 2020. Increases for the three-month and six-month periods year over year included:

•$1.1 million and $3.8 million, respectively, in employee and consultant stock-based compensation;

•$1.0 million and $1.4 million, respectively, in employee compensation;

•$84,000 and $2.0 million, respectively, in legal and accounting expenses; and

•$588,000 and $1.0 million, respectively, in insurance expenses.

Table of Contents

These increases were partially offset by lower expenses for work performed related to corporate marketing and communications of $640,000 and $1.3 million, respectively, among other variances.

Stock-based compensation. Stock-based compensation expense is measured at the grant date, based on the fair value of the award, and is recognized as expense over the requisite vesting period. Total employee and director stock-based compensation expense for the three and six months ended June 30, 2021 was $5.3 million and $14.5 million, respectively. Of these amounts, $2.7 million and $7.9 million, respectively, was included in research and development expenses, and $2.6 million and $6.6 million, respectively, was included in general and administrative expenses. Total employee and director stock-based compensation expense for the three and six months ended June 30, 2020 was $3.4 million and $7.1 million, respectively. Of these amounts, $1.8 million and $4.1 million, respectively, was included in research and development expenses, and $1.6 million and $3.0 million, respectively, was included in general and administrative expenses. The year over year increase was primarily related to a higher weighted average grant date fair value for the awards granted in the first quarter 2021 and grants vesting during the period.

Interest income. Interest income for the three and six months ended June 30, 2021 was $928,000 and $1.7 million, respectively, as compared to $1.1 million and $1.5 million, respectively, for the three and six months ended June 30, 2020.

Interest expense. Interest expense for the three and six months ended June 30, 2021 was $467,000 and $980,000, respectively, as compared to $2.8 million and $5.7 million, respectively, for the three and six months ended June 30, 2020. The decrease for the three and six-month periods year over year was due to less interest expense recorded for our convertible senior notes, or the Notes, due to the partial conversions of the Notes into shares of our common stock in the third and fourth quarters of 2020 and full conversion of December 2021 Bonds in March 2021, as well as no interest expense recorded on our August 2019 Bonds due to their full conversion into shares of our common stock in August 2020.

Change in fair value of derivative liability. The change in fair value of derivative liability for the three and six months ended June 30, 2020 was $97.8 million and $111.0 million, respectively. We determined that our August 2019 Bonds included an embedded conversion feature that was considered to be a derivative liability requiring bifurcation from the debt instrument and separate recognition in our financial statements. The conversion feature was revalued at the end of each reporting period and immediately prior to the conversion of the August 2019 Bonds in August 2020, with the resulting changes in fair value reflected in the condensed consolidated statements of operations. There was no change in fair value for the three and six months ended June 30, 2021, as the derivative liability was derecognized upon the conversion in full of the August 2019 Bonds in August 2020.

Gain (loss) on investment in affiliated entities. The gain (loss) results from the change in the fair market value of our investment in PLS for a gain of $279,000 and a loss of $552,000, respectively, for the three and six months ended June 30, 2021 as compared to the change in the fair market value of the investments in PLS and GeneOne for a loss of $3.9 million and gain of $9.3 million, respectively, for the three and six months ended June 30, 2020. During the third quarter of 2020, we sold our full equity interest in GeneOne. We record our investment in PLS at its market value based on the closing price of the shares on the Korea New Exchange Market at each balance sheet date, with changes in fair value reflected in the condensed consolidated statements of operations.

Net unrealized gain (loss) on available-for-sale equity securities. The net unrealized gain (loss) on available-for-sale equity securities for the three and six months ended June 30, 2021 of $136,000 and $(711,000), respectively, as compared to $4.4 million and $(691,000), respectively, for the three and six months ended June 30, 2020, resulted from a change in the fair market value of the investments.

Gain on deconsolidation of Geneos. The gain recorded represents the excess of the fair value of our retained noncontrolling investment in Geneos and the carrying amount of the noncontrolling interest over the carrying amount of Geneos' assets and liabilities as of June 1, 2020, the date of deconsolidation.

Share in net loss of Geneos. The share in net loss of Geneos represents our share of Geneos' losses during the period after deconsolidation in June 2020.

Liquidity and Capital Resources

Historically, our primary uses of cash have been to finance research and development activities including clinical trial activities in the oncology, DNA vaccines and other immunotherapy areas of our business. Since inception, we have satisfied our cash requirements principally from proceeds from the sale of equity securities, indebtedness and grants and government contracts.

Working Capital and Liquidity

As of June 30, 2021, we had cash, cash equivalents and short-term investments of $443.7 million and working capital of $490.7 million, as compared to $411.6 million and $429.5 million, respectively, as of December 31, 2020. The increase in cash and short-term investments during the six months ended June 30, 2021 was primarily due to the net proceeds from the sale of

our common stock in an underwritten public offering in January 2021, offset by expenditures related to our research and development activities, clinical trials and various general and administrative expenses related to legal, consultants, accounting and audit, and corporate development.

Cash Flows

Net cash used in operating activities was $131.3 million and $52.6 million for the six months ended June 30, 2021 and 2020, respectively. Net cash used in operating activities for the six months ended June 30, 2021 consisted of net loss of $136.5 million, less use of net cash in operating assets and liabilities of $14.0 million partially offset by net non-cash adjustments of $19.2 million. The net cash used in operating activities included a $27.8 million increase in prepaid expenses and other assets, primarily made up of prepayments for facilities, equipment and manufacturing related to INO-4800. The primary non-cash adjustments to net loss included stock-based compensation of $15.2 million, depreciation and amortization of $1.6 million, and net unrealized loss on available-for-sale equity securities of $711,000, among other items.

Net cash used in operating activities for the six months ended June 30, 2020 consisted of net loss of $162.3 million, less use of net cash in operating assets and liabilities of $913,000, partially offset by net non-cash adjustments of $110.6 million. The primary non-cash expenses added back to net loss included the increase in fair value of derivative liability of $111.0 million, stock-based compensation of $7.7 million, interest expense of $3.0 million and depreciation and amortization of $1.9 million. These non-cash expenses were offset by non-cash gain on investment in affiliated entities of $9.3 million, gain on deconsolidation of Geneos of $4.1 million and the acquisition of investment in our affiliated entity PLS of $1.7 million through the settlement of accounts receivable with additional shares of PLS common stock.

Net cash used in investing activities was $224.8 million and $94.2 million for the six months ended June 30, 2021 and 2020, respectively. The variance was primarily the result of timing differences in short-term investment purchases, sales and maturities.

Net cash provided by financing activities was $164.3 million and $340.0 million for the six months ended June 30, 2021 and 2020, respectively. The variance was primarily due to the proceeds from the sale of common stock under the ATM sales agreement in 2020, offset by the net proceeds from the January 2021 underwritten public offering.

Issuances of Common Stock

On January 25, 2021, we closed an underwritten public offering of 20,355,000 shares of our common stock at a public offering price of $8.50 per share. The net proceeds, after deducting the underwriters' discounts and commissions and other estimated offering expenses payable by us, were $162.1 million.

In May 2018, we entered into an At-the-Market Equity Offering Sales Agreement, or the Sales Agreement, with an outside placement agent, or the Placement Agent, to sell shares of our common stock with aggregate gross proceeds of up to $100.0 million, from time to time, through an “at-the-market” equity offering program under which the Placement Agent would act as sales agent. In the first quarter of 2020, we entered into amendments to the Sales Agreement to increase the amount of our common stock that could be sold through the Placement Agent under the Sales Agreement to an aggregate offering price of up to $250.0 million. During the three months ended March 31, 2020, we sold 43,148,952 shares of common stock under the Sales Agreement for aggregate net proceeds of $208.2 million. Following these sales, there was no remaining capacity under this Sales Agreement.

On April 3, 2020, we entered into a new sales agreement, or the New Sales Agreement, with the same Placement Agent to sell shares of our common stock. On that same day, we filed a prospectus supplement pursuant to the New Sales Agreement for the offer and sale of our common stock for aggregate gross proceeds of up to $150.0 million. On May 12, 2020 we filed an additional prospectus supplement pursuant to the New Sales Agreement for the offer and sale of our common stock for an additional $100.0 million of gross proceeds, bringing the maximum gross proceeds of sales under the New Sales Agreement to $250.0 million. Through December 31, 2020, we sold 22,915,934 shares of common stock under the New Sales Agreement for aggregate net proceeds of $246.2 million. As of December 31, 2020, there was no remaining capacity under the New Sales Agreement.

During the six months ended June 30, 2021, stock options to purchase 1,194,696 shares of common stock were exercised for aggregate net proceeds to us of $6.2 million, which proceeds were offset by tax payments made related to net share settlement of RSU awards of $3.9 million. During the six months ended June 30, 2020, stock options to purchase 1,649,874 shares of common stock were exercised for aggregate net proceeds to us of $9.6 million, which proceeds were offset by tax payments made related to net share settlement of RSU awards of $2.1 million.

As of June 30, 2021, we had an accumulated deficit of $1.0 billion and we expect to continue to operate at a loss for some time. The amount of the accumulated deficit will continue to increase, as it will be expensive to continue research and development efforts. These activities will require additional financing. If these activities are successful and if we receive approval from the FDA to market our product candidates, then we will need to raise additional funding to market and sell the approved products and equipment. We cannot predict the outcome of the above matters at this time. We are evaluating potential

collaborations as an additional way to fund operations. We believe that our current cash and short-term investments are sufficient to meet our planned working capital requirements for at least the next twelve months from the date of this report.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

Contractual Obligations

During the three months ended March 31, 2021, all outstanding December 2019 Bonds were converted into 1,009,450 shares of our common stock. There were no other significant changes to our contractual obligations and commitments described under Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2020.

ITEM 3. QUALITATIVE AND QUANTITATIVE DISCLOSURES ABOUT MARKET RISK

Interest Rate Risk

Market risk represents the risk of loss that may impact our consolidated financial position, results of operations or cash flows due to adverse changes in financial and commodity market prices and rates. We are exposed to market risk primarily in the area of changes in United States interest rates and conditions in the credit markets, and the recent fluctuations in interest rates and availability of funding in the credit markets primarily impact the performance of our investments. We do not have any material foreign currency or other derivative financial instruments. Under our current policies, we do not use interest rate derivative instruments to manage exposure to interest rate changes. We attempt to increase the safety and preservation of our invested principal funds by limiting default risk, market risk and reinvestment risk. We mitigate default risk by investing in investment grade securities. Due to the short-term maturities of our cash equivalents and the low risk profile of our investments at June 30, 2021, an immediate 100 basis point change in interest rates would not have a material effect on the fair market value of our cash equivalents.

The interest rate on our indebtedness, consisting of the Notes, is fixed and not subject to fluctuations in interest rates.

Fair Value Measurements

The investment in affiliated entity at June 30, 2021 represents our ownership interest in the Korean-based company PLS. We report this investment at fair value on the condensed consolidated balance sheet using the closing price of PLS shares of common stock as reported on the date of determination on the Korea New Exchange Market.

Foreign Currency Risk

We have operated primarily in the United States and most transactions during the three and six months ended June 30, 2021 were made in United States dollars. Accordingly, we have not had any material exposure to foreign currency rate fluctuations, with the exception of certain cash and cash equivalents held in South Korea that are denominated in South Korean Won and the valuation of our equity investment in PLS, which is denominated in South Korean Won and then translated into United States dollars. We do not have any foreign currency hedging instruments in place.

Certain transactions are denominated primarily in foreign currencies, including South Korean Won, Euros, British Pounds and Canadian Dollars. These transactions give rise to monetary assets and liabilities that are denominated in currencies other than the U.S. dollar. The value of these monetary assets and liabilities are subject to changes in currency exchange rates from the time the transactions are originated until settlement in cash. As a result, our financial results could be affected by factors such as changes in foreign currency exchange rates or weak economic conditions in foreign markets where we conduct business.

We do not use derivative financial instruments for speculative purposes and do not engage in exchange rate hedging or hold or issue foreign exchange contracts for trading purposes.

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures, which are designed to ensure that information required to be disclosed in the reports we file or submit under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer, or CEO, and Chief Financial Officer, or CFO, as appropriate to allow timely decisions regarding required disclosures.

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In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.

Based on an evaluation carried out as of the end of the period covered by this Quarterly Report, under the supervision and with the participation of our management, including our CEO and CFO, our CEO and CFO have concluded that, as of the end of such period, our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934) were effective as of June 30, 2021 at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

There have not been any changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2021 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Part II. Other Information

ITEM 1. LEGAL PROCEEDINGS

Securities Litigation

On March 12, 2020, a purported shareholder class action complaint, McDermid v. Inovio Pharmaceuticals, Inc. and J. Joseph Kim, was filed in the United States District Court for the Eastern District of Pennsylvania, naming us and J. Joseph Kim, our Chief Executive Officer, as defendants. The lawsuit alleges that we made materially false and misleading statements regarding our development of a vaccine for COVID-19 in our public disclosures in violation of certain federal securities laws. The plaintiff seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including reasonable attorneys’ fees. On June 18, 2020, the court appointed Manuel Williams to serve as lead plaintiff. On August 3, 2020, Mr. Williams filed a consolidated complaint, naming us and three of our officers as defendants. On September 21, 2020, Mr. Williams and another purported stockholder, Andrew Zenoff filed a first amended complaint, naming us and three of our officers as defendants. Defendants filed a motion to dismiss plaintiff’s first amended complaint on November 5, 2020. On February 16, 2021, the court issued an order granting in part, and denying in part, Defendants’ motion to dismiss. The court granted Defendants’ motion to dismiss, and dismissed with prejudice, the claims premised on the April 30 and June 30, 2020 statements. The court denied Defendants’ motion to dismiss as to the remaining statements. On March 9, 2021, Defendants filed their answer to the complaint. On July 29, 2021, Plaintiffs moved to certify the class action. The case is now in discovery.

On April 20, 2020, a purported shareholder derivative complaint, Behesti v. Kim, et al., was filed in the United States District Court for the Eastern District of Pennsylvania, naming eight current and former directors as defendants. The lawsuit asserts state and federal claims and is based on the same alleged misstatements as the shareholder class action complaint. The lawsuit accuses our board of directors of failing to exercise reasonable and prudent supervision over our management, policies, practices, and internal controls. The plaintiff seeks unspecified monetary damages on behalf of us as well as governance reforms. On June 5, 2020, the court stayed the Beheshti action pending resolution of a forthcoming motion to dismiss the McDermid securities class action or until any party provides notice that they no longer consent to the stay. On June 12 and June 15, 2020, two additional shareholder derivative complaints were filed in the United States District Court for the Eastern District of Pennsylvania, captioned Isman v. Benito, et al. and Devarakonda et al. v Kim, et. al. The complaints assert substantially similar claims as the Beheshti action and name our current directors as defendants. The Devarakonda complaint also names one of our former directors as a defendant. On July 21, 2020, the court consolidated the three derivative cases under the caption In re Inovio Pharmaceuticals, Inc. Derivative Litigation. The consolidated action is stayed pending resolution of a forthcoming motion to dismiss the McDermid securities class action or until any party provides notice that they no longer consent to the stay.

On July 7, 2020, a fourth shareholder derivative complaint, Fettig v. Kim et al., was filed in the United States District Court for the Eastern District of Pennsylvania, naming eight current and former directors as defendants. The complaint asserts substantially similar claims as those in the consolidated derivative action. On August 27, 2020, the Fettig action was consolidated with the other derivative cases, which remain stayed as explained above.

We intend to defend these actions vigorously.

VGXI Litigation

On June 3, 2020, we filed a complaint in the Court of Common Pleas of Montgomery County, Pennsylvania against VGXI, Inc. and GeneOne Life Science, Inc., or GeneOne, and together with VGXI, Inc. collectively referred to as VGXI, alleging that VGXI had materially breached our supply agreement with them. The complaint seeks declaratory judgments, specific performance of the agreement, injunctive relief, an accounting, damages, attorneys’ fees, interest, costs and other relief from VGXI. On June 3, 2020, we filed a petition for preliminary injunction, which was denied on June 25, 2020. On June 26, 2020, we filed notice of appeal of the denial of the petition with the Pennsylvania Superior Court.

On July 7, 2020, VGXI filed an answer, new matter and counterclaims against us, alleging that we had breached the supply agreement, as well as misappropriation of trade secrets and unjust enrichment. The counterclaims seek injunctive relief, damages, attorneys’ fees, interest, costs and other relief from us. Also, on July 7, 2020, VGXI filed a third-party complaint against Ology Bioservices, Inc., a contract manufacturing organization that we had engaged to provide services similar to those that were being provided by VGXI. On July 27, 2020, we filed an answer to VGXI’s counterclaims, disputing the allegations and the claims raised in VGXI’s filing. On October 1, 2020, we filed a notice of discontinuance of appeal with the Pennsylvania Superior Court. A trial date for the litigation has not been set.

We intend to aggressively prosecute the claims set forth in our complaint against VGXI and to vigorously defend ourselves against VGXI’s counterclaims.

On December 7, 2020, GeneOne filed a complaint in the Court of Common Pleas of Montgomery County, Pennsylvania against us, alleging that we had breached the CELLECTRA Device License Agreement, or the Agreement, between us and GeneOne. We terminated the Agreement on October 9, 2020. The complaint asserts claims for breach of contract, declaratory

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judgment, unfair competition, and unjust enrichment. The complaint seeks injunctive relief, an accounting, damages, disgorgement of profits, attorneys’ fees, interest, and other relief from us. We intend to vigorously defend ourselves against GeneOne’s claims. On January 29, 2021, we filed preliminary objections to the complaint.

ITEM 1A. RISK FACTORS

Our business is subject to numerous risks. You should carefully consider and evaluate each of the following factors as well as the other information in this Quarterly Report on Form 10-Q, including our financial statements and the related notes, the risk factors discussed in our 2020 Annual Report, which we filed with the SEC on March 1, 2021, in evaluating our business and prospects. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently consider immaterial may also impair our business operations. If any of the following risks actually occur, our business and financial results could be harmed. In that case, the trading price of our common stock could decline. You should also consider the more detailed description of our business contained in our 2020 Annual Report.

Risks Related to Our Financial Position and Need for Additional Capital

We have incurred losses since inception, expect to incur significant net losses in the foreseeable future and may never become profitable.

We have experienced significant operating losses to date; as of June 30, 2021, our accumulated deficit was approximately $1.0 billion. We have generated limited revenues, primarily consisting of license revenue, grant funding and interest income. We expect to continue to incur substantial additional operating losses for at least the next several years as we advance our clinical trials and research and development activities. We may never successfully commercialize our DNA vaccine, DNA immunotherapy and dMAB product candidates or electroporation-based synthetic vaccine delivery technology and thus may never have any significant future revenues or achieve and sustain profitability.

We have limited sources of revenue and our success is dependent on our ability to develop our DNA vaccines, DNA immunotherapies, dMAbs and electroporation equipment.

We do not sell any products and may not have any other products commercially available for several years, if at all. Our ability to generate future revenues depends heavily on our success in:

•developing and securing United States and/or foreign regulatory approvals for our product candidates, including securing regulatory approval for conducting clinical trials with product candidates;

•developing our electroporation-based DNA delivery technology; and

•commercializing any products for which we receive approval from the FDA and foreign regulatory authorities.

Our electroporation equipment and product candidates will require extensive additional clinical study and evaluation, regulatory approval in multiple jurisdictions, substantial investment and significant marketing efforts before we generate any revenues from product sales. We are not permitted to market or promote our electroporation equipment and product candidates before we receive regulatory approval from the FDA or comparable foreign regulatory authorities. If we do not receive regulatory approval for and successfully commercialize any products, we will not generate any revenues from sales of electroporation equipment and products, and we may not be able to continue our operations.

We will need substantial additional capital to develop our DNA vaccines, DNA immunotherapies and dMAb programs and electroporation delivery technology.

Conducting the costly and time-consuming research, pre-clinical studies and clinical testing necessary to obtain regulatory approvals and bring our product candidates and delivery technology to market will require a commitment of substantial funds in excess of our current capital. Our future capital requirements will depend on many factors, including, among others:

•the progress of our current and new product development programs;

•the progress, scope and results of our pre-clinical and clinical testing;

•the time and cost involved in obtaining regulatory approvals;

•the cost of manufacturing our products and product candidates;

•the cost of prosecuting, enforcing and defending against patent infringement claims and other intellectual property rights;

•debt service obligations;

•competing technological and market developments; and

•our ability and costs to establish and maintain collaborative and other arrangements with third parties to assist in potentially bringing our products to market.

Additional financing may not be available on acceptable terms, or at all. Domestic and international capital markets have from time to time experienced heightened volatility and turmoil, particularly in light of the COVID-19 pandemic, making it more difficult in many cases to raise capital through the issuance of equity securities. Volatility in the capital markets can also negatively impact the cost and availability of credit, creating illiquid credit markets and wider credit spreads. Concern about the stability of the markets generally and the strength of counterparties specifically has led many lenders and institutional investors to reduce, and in some cases cease to provide, funding to borrowers. To the extent we are able to raise additional capital through the sale of equity securities, or we issue securities in connection with another transaction in the future, the ownership position of existing stockholders could be substantially diluted. If additional funds are raised through the issuance of preferred stock or debt securities, these securities are likely to have rights, preferences and privileges senior to our common stock and may involve significant fees, interest expense, restrictive covenants and the granting of security interests in our assets. Fluctuating interest rates could also increase the costs of any debt financing we may obtain. Raising capital through a licensing or other transaction involving our intellectual property could require us to relinquish valuable intellectual property rights and thereby sacrifice long-term value for short-term liquidity.

Our failure to successfully address ongoing liquidity requirements would have a substantially negative impact on our business. If we are unable to obtain additional capital on acceptable terms when needed, we may need to take actions that adversely affect our business, our stock price and our ability to achieve cash flow in the future, including possibly surrendering our rights to some technologies or product opportunities, delaying our clinical trials or curtailing or ceasing operations.

Risks Related to Product Development, Manufacturing and Regulatory Approval

If we are unable to obtain FDA approval of our products, we will not be able to commercialize them in the United States.

We need FDA approval prior to marketing our electroporation equipment and product candidates in the United States. If we fail to obtain FDA approval to market our electroporation equipment and product candidates, we will be unable to sell our products in the United States, which will significantly impair our ability to generate any revenues.

This regulatory review and approval process, which includes evaluation of preclinical studies and clinical trials of our products as well as the evaluation of our manufacturing processes and our third-party contract manufacturers' facilities, is lengthy, expensive and uncertain. To receive approval, we must, among other things, demonstrate with substantial evidence from well-controlled clinical trials that our electroporation equipment and product candidates are both safe and effective for each indication for which approval is sought. To the extent that our product candidates are manufactured at multiple sites or using different processes, we will also need to demonstrate comparability across the manufacturing batches in order to obtain regulatory approval. Satisfaction of the approval requirements typically takes several years and the time needed to satisfy them may vary substantially, based on the type, complexity and novelty of the product. We do not know if or when we might receive regulatory approvals for our electroporation equipment and any of our product candidates currently under development. Moreover, any approvals that we obtain may not cover all of the clinical indications for which we are seeking approval, or could contain significant limitations in the form of narrow indications, warnings, precautions or contra-indications with respect to conditions of use. In such event, our ability to generate revenues from such products would be greatly reduced and our business would be harmed.

The FDA has substantial discretion in the approval process and may either refuse to consider our application for substantive review or may form the opinion after review of our data that our application is insufficient to allow approval of our electroporation equipment and product candidates. If the FDA does not consider or approve our application, it may require that we conduct additional clinical, preclinical or manufacturing validation studies and submit that data before it will reconsider our application. Depending on the extent of these or any other studies, approval of any applications that we submit may be delayed by several years, or may require us to expend more resources than we have available. It is also possible that additional studies, if performed and completed, may not be successful or considered sufficient by the FDA for approval or even to make our applications approvable. If any of these outcomes occur, we may be forced to abandon one or more of our applications for approval, which might significantly harm our business and prospects.

It is possible that none of our products or any product we may seek to develop in the future will ever obtain the appropriate regulatory approvals necessary for us or our collaborators to commence product sales. Any delay in obtaining, or an inability to obtain, applicable regulatory approvals would prevent us from commercializing our products, generating revenues and achieving and sustaining profitability.

Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.

Clinical testing is expensive and can take many years to complete, and its outcome is uncertain. Failure can occur at any time during the clinical trial process. The results of preclinical studies and early clinical trials of our products may not be predictive of the results of later-stage clinical trials. Results from one study may not be reflected or supported by the results of similar studies. Results of an animal study may not be indicative of results achievable in human studies. Human-use equipment and product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having

progressed through preclinical studies and initial clinical testing. The time required to obtain approval by the FDA and similar foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials, depending upon numerous factors. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change. We have not obtained regulatory approval for any human-use products.

Our products could fail to complete the clinical trial process for many reasons, including the following:

•we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our electroporation equipment or product candidate is safe and effective for any indication;

•the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;

•the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;

•we may not be successful in enrolling a sufficient number of participants in clinical trials;

•we may be unable to demonstrate that our electroporation equipment or product candidates' clinical and other benefits outweigh its safety risks;

•we may be unable to demonstrate that our electroporation equipment or product candidate presents an advantage over existing therapies, or over placebo in any indications for which the FDA requires a placebo-controlled trial;

•the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;

•the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a new drug application or other submission or to obtain regulatory approval in the United States or elsewhere;

•the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of us or third-party manufacturers with which we or our collaborators contract for clinical and commercial supplies; and

•the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

Our product candidates are combination products regulated under both the biologic and device regulations of the Public Health Service Act and Federal Food, Drug, and Cosmetic Act. Third-party manufacturers may not be able to comply with cGMP regulations, regulations applicable to biologic/device combination products, including applicable provisions of the FDA’s drug cGMP regulations, device cGMP requirements embodied in the QSR or similar regulatory requirements outside the United States. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could significantly affect supplies of our product candidates.

Clinical trials may also be delayed as a result of ambiguous or negative interim results. In addition, a clinical trial may be suspended or terminated by us, the FDA, the IRB overseeing the clinical trial at issue, any of our clinical trial sites with respect to that site, or other regulatory authorities due to a number of factors, including:

•failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;

•inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;

•unforeseen safety issues; and

•lack of adequate funding to continue the clinical trial.

If we experience delays in completion of, or if we terminate, any of our clinical trials, the commercial prospects for our electroporation equipment and our product candidates may be harmed and our ability to generate product revenues will be delayed. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate. Further, delays in the commencement or completion of clinical trials may adversely affect the trading price of our common stock.

Delays in the commencement or completion of clinical testing could result in increased costs to us and delay or limit our ability to generate revenues.

Delays in the commencement or completion of clinical testing could significantly affect our product development costs. We do not know whether planned clinical trials will begin on time or be completed on schedule, if at all. In addition, ongoing clinical trials may not be completed on schedule, or at all, and could be placed on a hold by the regulators for various reasons. The commencement and completion of clinical trials can be delayed for a number of reasons, including delays related to:

•obtaining regulatory approval to commence a clinical trial;

•adverse results from third party clinical trials involving gene-based therapies and the regulatory response thereto;

•reaching agreement on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

•future bans or stricter standards imposed on clinical trials of gene-based therapy;

•manufacturing sufficient quantities of our electroporation equipment and product candidates for use in clinical trials;

•obtaining institutional review board, or IRB, approval to conduct a clinical trial at a prospective site;

•slower than expected recruitment and enrollment of patients to participate in clinical trials for a variety of reasons, including competition from other clinical trial programs for similar indications or, with respect to our clinical trials for INO-4800, mass vaccination efforts;

•conducting clinical trials with sites internationally due to regulatory approvals and meeting international standards;

•retaining patients who have initiated a clinical trial but may be prone to withdraw due to side effects from the therapy, lack of efficacy or personal issues, or who are lost to further follow-up;

•collecting, reviewing and analyzing our clinical trial data; and

•global unrest, global pathogen outbreaks or pandemics, terrorist activities, and economic and other external factors.

•failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;

•inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;

•unforeseen safety issues; and

•lack of adequate funding to continue the clinical trial.

None of our human vaccine candidates, including INO-4800, or our immunotherapy and DNA encoded monoclonal antibody product candidates have been approved for sale, and we may never develop commercially successful vaccine, immunotherapy or DNA encoded monoclonal antibody products.

Our human vaccine programs, which includes our COVID-19 vaccine candidate INO-4800, our immunotherapy programs and our DNA encoded monoclonal antibodies program are in various stages of research and development, and currently include product candidates in discovery, preclinical studies and Phase 1, 2 and 3 clinical trials. There are limited data regarding the efficacy of synthetic vaccine candidates and immunotherapy candidates compared with conventional vaccines, and we must conduct a substantial amount of additional research and development before the FDA or any comparable foreign regulatory authority will approve any of our vaccine product candidates, including INO-4800. The success of our efforts to develop and commercialize our product candidates, including INO-4800, could be delayed or fail for a number of reasons. For example, we could experience delays in product development and clinical trials. Our product candidates could be found to be ineffective or unsafe, or otherwise fail to receive necessary regulatory clearances to proceed with further clinical development or to be approved for marketing. Our products, even if they are deemed to be safe and effective by regulatory authorities, could be difficult to manufacture on a large scale or uneconomical to market, or our competitors could develop superior products more quickly and efficiently or more effectively market their competing products. The ability to manufacture sufficient quantities of INO-4800 on a large scale is particularly challenging and will require substantial resources and the engagement of third parties, which we may not be able to obtain on a timely basis, or at all.

In addition, adverse events, or the perception of adverse events, relating to vaccine and immunotherapy candidates and delivery technologies may negatively impact our ability to develop commercially successful products. For example, pharmaceutical companies have been subject to claims that the use of some pediatric vaccines has caused personal injuries, including brain damage, central nervous system damage and autism. These and other claims may influence public perception of the use of vaccine and immunotherapy products and could result in greater governmental regulation, stricter labeling requirements and potential regulatory delays in the testing or approval of our potential products.

Our planned Phase 3 clinical trial of INO-4800 in the United States as a potential COVID-19 vaccine has been placed on partial clinical hold by the U.S. FDA, which may cause delays in our ability to conduct clinical trials in the United States.

Our planned clinical development of INO-4800 in the United States as a potential COVID-19 vaccine has been placed on partial clinical hold by the U.S. FDA, which means that we cannot commence a Phase 3 clinical trial in the United States. Although the partial clinical hold does not necessarily prevent us from starting our planned Phase 3 clinical trials outside of the United States, foreign regulatory authorities may require that we satisfactorily resolve the FDA’s remaining questions relating to the CELLECTRA 2000 device, or such foreign regulatory authorities may impose similar requirements, before we can commence or complete the portion of our Phase 3 clinical trial to be conducted in foreign countries. We are actively working to address the FDA’s questions. There can be no assurance, however, regarding the timing of the FDA’s agreement to lift the partial clinical hold or whether we will ultimately be successful in obtaining any such determination from the FDA to do so.

Delays in the commencement of our Phase 3 clinical trial or completion of ongoing clinical testing for INO-4800 could significantly affect our product development costs. We do not know whether our planned Phase 3 clinical trial will begin on time or be completed on schedule, if at all. In addition, our ongoing clinical trials for INO-4800 may not be completed on schedule, or at all, and could be placed on additional holds by regulators either in the United States or in foreign jurisdictions for reasons unrelated to our current hold. If we experience delays in completion of, or if we terminate, any of our clinical trials relating to INO-4800, the commercial prospects for our product candidate may be harmed and our ability to generate product revenues will be delayed. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate. Further, delays in the commencement or completion of clinical trials may adversely affect the trading price of our common stock.

Newly emerging SARS-CoV-2 variants could reduce the immunogenicity and effectiveness of INO-4800 as a potential COVID-19 vaccine.

Multiple variants of the virus that causes COVID-19 have been documented in the United States and globally during this pandemic. The new SARS-CoV-2 variants could be less affected by the immune responses generated by INO-4800 in the vaccine recipients and therefore could reduce the overall efficacy of the vaccine in controlling severe COVID-19 disease.

There can be no assurance that the product we are developing for COVID-19 would be granted an Emergency Use Authorization by the FDA or similar authorization by regulatory authorities outside of the United States if we were to decide to apply for such an authorization. The option of seeking an Emergency Use Authorization may no longer exist if the public health emergency has expired or if a sufficient supply of COVID-19 vaccines have obtained full Biologics License Approval, or foreign equivalent, by the time we are ready to submit an application. If we do not timely apply for such an emergency use authorization or, if we do apply and no authorization is granted or, once granted, it is terminated, we will be unable to sell our product in the near future and instead, will be required to pursue the biologic licensure process in order to sell our product, which is lengthy and expensive.

We may seek an Emergency Use Authorization, or EUA, from the FDA or similar authorization from regulatory authorities outside of the United States, such as conditional marketing authorization from the EMA. If we apply for an EUA and it is granted, an EUA will authorize us to market and sell our COVID-19 vaccine under certain conditions of authorization as long as the public health emergency exists. The FDA expects that companies which receive an EUA for COVID-19 vaccines will proceed to licensure of their vaccine products under a full Biologics License Application. The FDA may issue an EUA during a Public Health Emergency if the agency determines that the potential benefits of a product outweigh the potential risks and if other regulatory criteria are met. There is no guarantee that we will apply for an EUA or other similar authorization or, if we do apply, that we will be able to obtain such authorization. If an EUA or other authorization is granted, we will rely on the FDA or other applicable regulatory authority policies and guidance governing vaccines authorized in this manner in connection with the marketing and sale of our product. If these policies and guidance change unexpectedly and/or materially or if we misinterpret them, potential sales of our product could be adversely impacted. An EUA authorizing the marketing and sale of our product will terminate upon expiration of the Public Health Emergency, which is a determination made by the Secretary of Health and Human Services. The FDA may also terminate an EUA if safety issues or other concerns about our product arise or if we fail to comply with the conditions of authorization. If our competitors obtain full biologics licensure, the FDA or foreign regulatory authorities may no longer grant EUAs for COVID-19 vaccines if the medical need has been met, thereby forcing us to seek full biologics licensure. If we apply for an EUA or similar authorization from regulatory authorities outside of the United States, the failure to obtain such authorization or the termination of such an authorization, if obtained, would adversely impact our ability to market and sell our COVID-19 vaccine, which could adversely impact our business, financial condition and results of operations.

If we and the contract manufacturers upon whom we rely fail to produce our electroporation devices and product candidates in the volumes that we require on a timely basis, or at all, or fail to comply with their obligations to us or with stringent regulations, we may face delays in the development and commercialization of our electroporation equipment and product candidates.

We manufacture some components of our electroporation devices and utilize the services of contract manufacturers to manufacture the remaining components of these devices. We also rely on third party contract manufacturers to produce our product candidates for use in our clinical trials and potentially for commercial distribution, if any product candidate is approved by regulatory authorities. The manufacture of these devices and our product candidates requires significant expertise and capital

investment, including the development of advanced manufacturing techniques and process controls. Manufacturers often encounter difficulties in production, particularly in scaling up for commercial production. These problems include difficulties with production costs and yields, quality control, including stability of the equipment and product candidates and quality assurance testing, shortages of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations.

If we or our manufacturers were to encounter any of these difficulties or our manufacturers otherwise fail to comply with their obligations to us, our ability to provide our electroporation equipment to our partners and to supply product candidates for clinical trials or to commercially launch a product would be jeopardized. For example, we previously relied on VGXI to manufacture DNA plasmids for our product candidates, including INO-4800. In 2020, VGXI notified us that they would be unable to produce the necessary plasmids to meet this timeline due to a lack of manufacturing capacity. As a result, we have engaged several additional third-party contract manufacturers to support the planned large-scale manufacturing of INO-4800. However, there can be no assurance that we will be able to secure adequate additional manufacturing capacity on commercially reasonable terms. Our inability to secured sufficient manufacturing capacity, or our inability to transfer necessary manufacturing know-how to third parties, would adversely affect our commercialization plans and could also harm our reputation.

Furthermore, any delay or interruption in the supply of clinical trial supplies for INO-4800 or any of our other product candidates could delay the completion of our clinical trials, increase the costs associated with maintaining our clinical trial program and, depending upon the period of delay, require us to commence new trials at significant additional expense or terminate the trials completely.

In addition, all manufacturers of our products must comply with cGMP requirements enforced by the FDA through its facilities inspection program. These requirements include, among other things, quality control, quality assurance and the generation and maintenance of records and documentation. Manufacturers of our products may be unable to comply with these cGMP requirements and with other FDA, state and foreign regulatory requirements. We have little control over our manufacturers' compliance with these regulations and standards. A failure to comply with these requirements may result in fines and civil penalties, suspension of production, suspension or delay in product approval, product seizure or recall, or withdrawal of product approval. If the safety of any product is compromised due to our or our manufacturers' failure to adhere to applicable laws or for other reasons, we may not be able to obtain regulatory approval for or successfully commercialize our products, and we may be held liable for any injuries sustained as a result. Any of these factors could cause a delay of clinical trials, regulatory submissions, approvals or commercialization of our products, entail higher costs or result in our being unable to effectively commercialize our products. Furthermore, if our manufacturers fail to deliver the required commercial quantities on a timely basis, pursuant to provided specifications and at commercially reasonable prices, we may be unable to meet demand for our products and would lose potential revenues.

Even if our products receive regulatory approval, they may still face future development and regulatory difficulties.

Even if United States regulatory approval is obtained, the FDA may still impose significant restrictions on a product's indicated uses or marketing or impose ongoing requirements for potentially costly post-approval studies. This governmental oversight may be particularly strict with respect to gene-based therapies. Our products will also be subject to ongoing FDA requirements governing the labeling, packaging, storage, advertising, promotion, record keeping and submission of safety and other post-market information. For example, the FDA strictly regulates the promotional claims that may be made about medical products. In particular, a product may not be promoted for uses that are not approved by the FDA as reflected in the product’s approved labeling. Physicians, on the other hand, may prescribe products for off-label uses. Although the FDA and other regulatory agencies do not regulate a physician’s choice of drug treatment made in the physician’s independent medical judgment, they do restrict promotional communications from companies or their sales force with respect to off-label uses of products for which marketing clearance has not been issued. However, companies may in certain circumstances share truthful and not misleading information that is otherwise consistent with the product’s FDA approved labeling. In addition, manufacturers of drug products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with current good manufacturing practices, or cGMP, regulations. If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturer or us, including requiring withdrawal of the product from the market or suspension of manufacturing. If we, our product candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, a regulatory agency may:

•issue Warning Letters or untitled letters;

•impose civil or criminal penalties;

•suspend regulatory approval;

•suspend any ongoing clinical trials;

•refuse to approve pending applications or supplements to applications filed by us;

•impose restrictions on operations, including costly new manufacturing requirements; or

•seize or detain products or require us to initiate a product recall.

Even if our products receive regulatory approval in the United States, we may never receive approval or commercialize our products outside of the United States.

In order to market any electroporation equipment and product candidates outside of the United States, we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy. Approval procedures vary among countries and can involve additional product testing and additional administrative review periods. The time required to obtain approval in other countries might differ from that required to obtain FDA approval, and the regulatory approval process in other countries may include all of the risks detailed above regarding FDA approval in the United States as well as other risks. For example, in connection with our planned Phase 3 clinical trials of INO-4800 to be conducted outside of the United States, some regulatory authorities have indicated concerns with placebo-controlled efficacy trials of a COVID-19 vaccine, which means that we would not be able to open clinical trial sites in those countries. Furthermore, regulatory approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in others. Failure to obtain regulatory approval in other countries or any delay or setback in obtaining such approval could have the same adverse effects detailed above regarding FDA approval in the United States. Such effects include the risks that our product candidates may not be approved for all indications requested, which could limit the uses of our product candidates and have an adverse effect on their commercial potential or require costly, post-marketing follow-up studies.

We have obtained Orphan Drug Designation for one of our product candidates. As part of our business strategy, we may continue to seek Orphan Drug Designation for additional product candidates, and we may be unsuccessful in obtaining new designations or may be unable to obtain or maintain the benefits associated with Orphan Drug Designation, including the potential for orphan drug exclusivity.

We have obtained Orphan Drug Designation from the FDA for INO-3107 for the treatment of for the treatment of recurrent respiratory papillomatosis. We have sought and may continue to seek Orphan Drug Designation for one or more of our other product candidates, including but not limited to VGX-3100 for the treatment of HPV-16-/18-associated anal dysplasia, although we may be unsuccessful in doing so. Regulatory authorities in some jurisdictions, including the United States and Europe, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a drug as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States. In the United States, Orphan Drug Designation entitles a party to financial incentives such as tax advantages and user fee waivers. Opportunities for grant funding toward clinical trial costs may also be available for clinical trials of drugs for rare diseases, regardless of whether the drugs are designated for the orphan use. In addition, if a product that has Orphan Drug Designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications to market the same product for the same indication for seven years, except in limited circumstances.

Although we have obtained Orphan Drug Designation for INO-3107 for the treatment of for the treatment of recurrent respiratory papillomatosis, and even if we obtain Orphan Drug Designation for our other product candidates in specific indications, we may not be the first to obtain marketing approval of these product candidates for the orphan-designated indication due to the uncertainties associated with developing pharmaceutical products. If a competitor with a product that is determined by the FDA to be the same as one of our product candidates obtains marketing approval before us for the same indication we are pursuing and obtains orphan drug exclusivity, our product candidate may not be approved until the period of exclusivity ends unless we are able to demonstrate that our product candidate is clinically superior. Even after obtaining approval, we may be limited in our ability to market our product. In addition, exclusive marketing rights in the United States may be limited if we seek approval for an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition. Further, even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs with different principal molecular structural features can be approved for the same condition. Even after an orphan product is approved, the FDA can subsequently approve the same drug with the same principal molecular structural features for the same condition if the FDA concludes that the later drug is safer, more effective or makes a major contribution to patient care. Orphan Drug Designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process. In addition, while we may seek Orphan Drug Designation for some of our product candidates, we may never receive such designations.

Tax reform legislation enacted in 2017 reduced the amount of the qualified clinical research costs for a designated orphan product that a sponsor may claim as a credit from 50% to 25%. This reduction could further limit the advantage of, and may impact our future business strategy with respect to, seeking the Orphan Drug Designation.

Risks Related to Reliance on Third Parties

If we lose or are unable to secure collaborators or partners, or if our collaborators or partners do not apply adequate resources to their relationships with us, our product development and potential for profitability will suffer.

We have entered into, and may continue to enter into, distribution, co-promotion, partnership, sponsored research and other arrangements for development, manufacturing, sales, marketing and other commercialization activities relating to our products. For example, in the past we have entered into license and collaboration agreements to develop, obtain regulatory approval for and commercialize our product candidates for specified indications, including in jurisdictions outside of the United States. The amount and timing of resources applied by our collaborators are largely outside of our control.

If any of our current or future collaborators breaches or terminates our agreements, or fails to conduct our collaborative activities in a timely manner, our commercialization of products could be diminished or blocked completely. We may not receive any event-based payments, milestone payments or royalty payments under our collaborative agreements if our collaborative partners fail to develop products in a timely manner or at all. It is possible that collaborators will change their strategic focus, pursue alternative technologies or develop alternative products, either on their own or in collaboration with others. Further, we may be forced to fund programs that were previously funded by our collaborators, and we may not have, or be able to access, the necessary funding. The effectiveness of our partners, if any, in marketing our products will also affect our revenues and earnings.

We desire to enter into new collaborative agreements. However, we may not be able to successfully negotiate any additional collaborative arrangements and, if established, these relationships may not be scientifically or commercially successful. Our success in the future depends in part on our ability to enter into agreements with other highly-regarded organizations. This can be difficult due to internal and external constraints placed on these organizations. Some organizations may have insufficient administrative and related infrastructure to enable collaborations with many companies at once, which can extend the time it takes to develop, negotiate and implement a collaboration. Once news of discussions regarding possible collaborations are known in the medical community, regardless of whether the news is accurate, failure to announce a collaborative agreement or the entity's announcement of a collaboration with another entity may result in adverse speculation about us, resulting in harm to our reputation and our business.

Disputes could also arise between us and our existing or future collaborators, as to a variety of matters, including financial and intellectual property matters or other obligations under our agreements. These disputes could be both expensive and time-consuming and may result in delays in the development and commercialization of our products or could damage our relationship with a collaborator.

A small number of licensing partners and government contracts account for a substantial portion of our revenue.

We currently derive, and in the past we have derived, a significant portion of our revenue from a limited number of licensing partners and government grants and contracts. Revenue can fluctuate significantly depending on the timing of upfront and event-based payments and work performed. If we fail to sign additional future contracts with major licensing partners and the government, if a contract is delayed or deferred, or if an existing contract expires or is canceled and we fail to replace the contract with new business, our revenue would be adversely affected.

We have agreements with government agencies, which are subject to termination and uncertain future funding.

We have entered into agreements with government agencies, such as the NIAID, DARPA and the DoD, and we intend to continue entering into these types of agreements in the future. Our business is partially dependent on the continued performance by these government agencies of their responsibilities under these agreements, including adequate continued funding of the agencies and their programs. We have no control over the resources and funding that government agencies may devote to these agreements, which may be subject to annual renewal and which generally may be terminated by the government agencies at any time. For example, in April 2021 we were notified by the DoD that they will discontinue funding for the Phase 3 segment of our INNOVATE trial.

Government agencies may fail to perform their responsibilities under these agreements, which may cause them to be terminated by the government agencies. In addition, we may fail to perform our responsibilities under these agreements. Many of our government agreements are subject to audits, which may occur several years after the period to which the audit relates. If an audit identifies significant unallowable costs, we could incur a material charge to our earnings or reduction in our cash position. As a result, we may be unsuccessful entering, or ineligible to enter, into future government agreements.

We and our collaborators rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we and our collaborators may not be able to obtain regulatory approval for or commercialize our product candidates.

We and our collaborators have entered into agreements with CROs to provide monitors for and to manage data for our on-going clinical programs. We and the CROs conducting clinical trials for our electroporation equipment and product candidates are required to comply with current good clinical practices, or GCPs, regulations and guidelines enforced by the FDA for all of our products in clinical development. The FDA enforces GCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If we or the CROs conducting clinical trials of our product candidates fail to comply with applicable GCPs, the clinical data generated in the clinical trials may be deemed unreliable and the FDA may require additional clinical trials before approving any marketing applications.

If any relationships with CROs terminate, we or our collaborators may not be able to enter into arrangements with alternative CROs. In addition, these third-party CROs are not our employees, and we cannot control whether or not they devote sufficient time and resources to our on-going clinical programs or perform trials efficiently. These CROs may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical studies or other drug development activities, which could harm our competitive position. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements, or for other reasons, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed. Cost overruns by or disputes with our CROs may significantly increase our expenses.

Risks Related to Commercialization of Our Product Candidates

We currently have no marketing and sales organization. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate product revenues.

We currently do not have a sales organization for the marketing, sales and distribution of our electroporation equipment and product candidates. In order to commercialize any products, we must build our marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services. We contemplate establishing our own sales force or seeking third-party partners to sell our products. The establishment and development of our own sales force to market any products we may develop will be expensive and time consuming and could delay any product launch, and we may not be able to successfully develop this capability. We will also have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train and retain marketing and sales personnel. To the extent we rely on third parties to commercialize our approved products, if any, we will receive lower revenues than if we commercialized these products ourselves. In addition, we may have little or no control over the sales efforts of third parties involved in our commercialization efforts. In the event we are unable to develop our own marketing and sales force or collaborate with a third-party marketing and sales organization, we would not be able to commercialize our product candidates which would negatively impact our ability to generate product revenues.

If products for which we receive regulatory approval do not achieve broad market acceptance, the revenues that we generate from their sales will be limited.

The commercial success of our electroporation equipment and product candidates for which we obtain marketing approval from the FDA or other regulatory authorities will depend upon the acceptance of these products by both the medical community and patient population. Coverage and reimbursement of our product candidates by third-party payors, including government payors, generally is also necessary for optimal commercial success. The degree of market acceptance of any of our approved products will depend on a number of factors, including:

•our ability to provide acceptable evidence of safety and efficacy;

•the relative convenience and ease of administration;

•the prevalence and severity of any actual or perceived adverse side effects;

•limitations or warnings contained in a product's FDA-approved labeling, including, for example, potential “black box” warnings

•availability of alternative treatments;

•pricing and cost effectiveness;

•the effectiveness of our or any future collaborators' sales and marketing strategies;

•the public perception of new therapies and the reputational challenges that the vaccine industry is facing related to the growing momentum of the anti-vaccine movement, including with respect to COVID-19 vaccines;

•our ability to obtain sufficient third-party coverage and adequate reimbursement; and

•the willingness of patients to pay out of pocket in the absence of third-party coverage.

If our electroporation equipment and product candidates are approved but do not achieve an adequate level of acceptance by physicians, healthcare payors and patients, we may not generate sufficient revenue from these products, and we may not become or remain profitable. In addition, our efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources and may never be successful.

We are subject to uncertainty relating to coverage and reimbursement policies which, if not favorable to our product candidates, could hinder or prevent our products' commercial success.

Patients in the United States and elsewhere generally rely on third-party payors to reimburse part or all of the costs associated with their prescription drugs and medical treatments. Accordingly, our ability to commercialize our electroporation equipment and product candidates successfully will depend in part on the extent to which governmental authorities, including Medicare and Medicaid, private health insurers and other third-party payors establish appropriate coverage and reimbursement levels for our product candidates and related treatments. As a threshold for coverage and reimbursement, third-party payors generally require that drug products have been approved for marketing by the FDA.

Significant uncertainty exists as to the coverage and reimbursement status of any products for which we may obtain regulatory approval. Coverage decisions may not favor new products when more established or lower cost therapeutic alternatives are already available. Even if we obtain coverage for a given product, the associated reimbursement rate may not be adequate to cover our costs, including research, development, intellectual property, manufacture, sale and distribution expenses, or may require co-payments that patients find unacceptably high. Patients are unlikely to use our products unless reimbursement is adequate to cover all or a significant portion of the cost of our drug products.

Additionally, some of our products, if approved, will be provided under the supervision of a physician. When used in connection with medical procedures, our product candidates may not be reimbursed separately but their cost may instead be bundled as part of the payment received by the provider for the procedure only. Separate reimbursement for the product itself or the treatment or procedure in which our product is used may not be available. A decision by a third-party payor not to cover or separately reimburse for our product candidates or procedures using our product candidates, could reduce physician utilization of our products once approved.

Coverage and reimbursement policies for drug products can differ significantly from payor to payor as there is no uniform policy of coverage and reimbursement for drug products among third-party payors in the United States. There may be significant delays in obtaining coverage and reimbursement as the process of determining coverage and reimbursement is often time consuming and costly which will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage or adequate reimbursement will be obtained. It is difficult to predict at this time what government authorities and third-party payors will decide with respect to coverage and reimbursement for our products.

A significant trend in the U.S. healthcare industry and elsewhere is cost containment. Third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular products and services. Third-party payors are increasingly challenging the effectiveness of and prices charged for medical products and services. Moreover, the U.S. government, state legislatures and foreign governmental entities have shown significant interest in implementing cost containment programs to limit the growth of government paid healthcare costs, including price controls, restrictions on reimbursement and coverage and requirements for substitution of generic products for branded prescription drugs. We may not be able to obtain third-party payor coverage or reimbursement for our products in whole or in part.

Risks Related to Managing Our Growth and Employee and Operational Matters

We are currently subject to litigation and may become subject to additional litigation, which could harm our business, financial condition and reputation.

We may have actions brought against us by stockholders relating to past transactions, changes in our stock price or other matters. For example, during 2020, numerous purported shareholder class action complaints have been filed against us, naming us and our directors and executive officers as defendants, and alleging that we made materially false and misleading statements regarding the development of our INO-4800 vaccine candidate against COVID-19 in violation of certain federal securities laws. We may also become party to litigation with third parties as a result of our business activities. In 2020, we filed a lawsuit against one of our contract manufacturers, who then filed a counterclaim against us alleging that we had breached our contract with them, among other claims. These litigation matters, described in this report, are ongoing, and even though we intend to vigorously defend ourselves in these actions, there can be no assurance that we will ultimately prevail. These and any potential future actions against us could give rise to substantial damages, which could have a material adverse effect on our financial position, liquidity or results of operations. Even if an action is not resolved against us, the uncertainty and expense associated with litigation could harm our business, financial condition and reputation, as litigation is often costly, time-consuming and disruptive to business operations. The defense of our existing and potential future lawsuits could also result in diversion of our management's time and attention away from business operations, which could harm our business.

Our business could be adversely affected by the effects of health epidemics, including the global COVID-19 pandemic.

In December 2019, a novel strain of coronavirus, since named SARS-CoV-2, causing the disease known as COVID-19, was reported in China. Since then, COVID-19 has spread globally, resulting in the World Health Organization (WHO) declaring the outbreak of COVID-19 as a “pandemic” in March 2020 and United States also declaring a national emergency. In response to the COVID-19 pandemic, a number of governmental orders and other public health guidance measures were implemented across much of the United States, including in the locations of our offices, laboratories, clinical trial sites and third parties on whom we rely. As a result, our expected clinical development timelines could be negatively affected by COVID-19, which could then materially and adversely affect our business, financial condition and results of operations. Further, we have implemented a work from home policy allowing employees who can work from home to do so, while those needing to work in laboratory facilities work in shifts to reduce the number of people gathered together at one time. We have also implemented a mask-wearing mandate for all on-site activities. Non-essential business travel has been suspended and online and teleconference technology is used to meet virtually rather than in person. We have taken measures to secure our research and development project activities, while work in laboratories has been organized to reduce risk of COVID-19 transmission. Our increased reliance on personnel working from home may negatively impact our productivity, or could disrupt, delay or otherwise adversely impact our business. For example, with our personnel working from home, some of our research activities that require our personnel to be in our laboratories could be delayed.

In addition, as local jurisdictions continue to put restrictions in place or reinstitute restrictions they had previously lifted, our ability to continue to conduct and enroll patients in our clinical trials, manufacture our product candidates and pursue collaborations may also be limited. Such events may result in business and manufacturing disruption, and in reduced operations, any of which could materially affect our business, financial condition and results of operations.

The spread of COVID-19, which has caused a broad impact globally, could also affect us economically. While the potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict, it has resulted in significant disruption of global financial markets, which could reduce our ability to access capital. Although we have raised significant funds from the sale of our common stock in the public markets during the pandemic, there can be no guarantee that we will be able to continue to so, which could negative affect our future liquidity. In addition, if a global economic recession results following the spread of COVID-19, including newly emerging SARS-CoV-2 variants, its impact could materially affect our business and the value of our common stock.

The continued spread of COVID-19, including newly emerging SARS-CoV-2 variants, globally has and could continue to adversely affect our clinical trial operations, including our ability to initiate and conduct our planned trials on their expected timelines and to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19 if an outbreak occurs in their geography. For example, COVID-19 has adversely impacted the timeline for data collection for our VGX-3100 program. An increasing number of trial participants are either not able or do not feel safe going into healthcare facilities, which is necessary for the collection and completion of data samples for this trial. As a result, it is taking longer than anticipated to complete the data collection process. Further, the COVID-19 outbreak could result in delays in our clinical trials due to prioritization of hospital resources toward the outbreak, restrictions in travel, potential unwillingness of patients to enroll in trials, patients withdrawing from trials following enrollment as a result of contracting COVID-19 or other health conditions, or the inability of patients to comply with clinical trial protocols as quarantines and travel restrictions impede patient movement or interrupt healthcare services. In addition, we rely on independent clinical investigators, contract research organizations and other third-party service providers to assist us in managing, monitoring and otherwise carrying out our preclinical studies and clinical trials, and the outbreak may affect their ability to devote sufficient time and resources to our programs or to travel to sites to perform work for us. These restrictions may delay the conduct of multiple clinical trials including our Phase 1 through 3 clinical trials.

Additionally, COVID-19 may also result in delays in receiving approvals from local and foreign regulatory authorities, delays in necessary interactions with local and foreign regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees, and refusals to accept data from clinical trials conducted in these affected geographies.

The global outbreak of COVID-19 continues to rapidly evolve. The extent to which COVID-19 may impact our business, operations and clinical trials will depend on future developments, including travel restrictions in the United States and other countries, the effectiveness of actions taken in the United States and other countries to contain and treat the disease, including mass vaccination efforts, and whether the United States and additional countries are required to move to complete lock-down status. The ultimate long-term impact of COVID-19 is highly uncertain.

We face intense and increasing competition and many of our competitors have significantly greater resources and experience.

If any of our competitors develop products with efficacy or safety profiles significantly better than our products, we may not be able to commercialize our products, and sales of any of our commercialized products could be harmed. Some of our

competitors and potential competitors have substantially greater product development capabilities and financial, scientific, marketing and human resources than we do. Competitors may develop products earlier, obtain FDA approvals for products more rapidly, or develop products that are more effective than those under development by us. We will seek to expand our technological capabilities to remain competitive; however, research and development by others may render our technologies or products obsolete or noncompetitive, or result in treatments or cures superior to ours.

Many other companies are pursuing other forms of treatment or prevention for diseases that we target. For example, many of our competitors are working on developing and testing COVID-19 vaccines, cancer vaccines and immunotherapies, and several products such as the CAR-Ts developed by our competitors have been approved for human use. Some of our competitors have already received regulatory approval for their COVID-19 vaccines and have mass vaccination efforts underway in our target markets. The earlier market entry of these other vaccines, and their actual or perceived efficacious or success relative to our own, has led to and may continue to lead to diversion of funding away from us, decreased demand for INO-4800, if approved, and difficulty in finding participants for our clinical trials. All of these factors could substantially impact our ability to complete the development of, commercialize and generate revenues from INO-4800.

In addition, our competitors and potential competitors include large pharmaceutical and more established biotechnology companies. These companies have significantly greater financial and other resources and greater expertise than us in research and development, securing government contracts and grants to support research and development efforts, manufacturing, preclinical and clinical testing, obtaining regulatory approvals and marketing. This may make it easier for them to respond more quickly than us to new or changing opportunities, technologies or market needs. Many of these competitors operate large, well-funded research and development programs and have significant products approved or in development. Small companies may also prove to be significant competitors, particularly through collaborative arrangements with large pharmaceutical companies or through acquisition or development of intellectual property rights. Our potential competitors also include academic institutions, governmental agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for product and clinical development and marketing. Research and development by others may seek to render our technologies or products obsolete or noncompetitive.

Our failure to successfully acquire, develop and market additional product candidates or approved products would impair our ability to grow.

We may acquire, in-license, develop and/or market additional products and product candidates. The success of these actions depends partly upon our ability to identify, select and acquire promising product candidates and products.

The process of proposing, negotiating and implementing a license or acquisition of a product candidate or approved product is lengthy and complex. Other companies, including some with substantially greater financial, marketing and sales resources, may compete with us for the license or acquisition of product candidates and approved products. We have limited resources to identify and execute the acquisition or in-licensing of third-party products, businesses and technologies and integrate them into our current infrastructure. Moreover, we may devote resources to potential acquisitions or in-licensing opportunities that are never completed, or we may fail to realize the anticipated benefits of such efforts. We may not be able to acquire the rights to additional product candidates on terms that we find acceptable, or at all.

In addition, future acquisitions may entail numerous operational and financial risks, including:

•exposure to unknown liabilities;

•disruption of our business and diversion of our management's time and attention to develop acquired products or technologies;

•incurrence of substantial debt or dilutive issuances of securities to pay for acquisitions;

•higher than expected acquisition and integration costs;

•increased amortization expenses;

•difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;

•impairment of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; and

•inability to retain key employees of any acquired businesses.

Further, any product candidate that we acquire may require additional development efforts prior to commercial sale, including extensive clinical testing and approval by the FDA and applicable foreign regulatory authorities. All product candidates are prone to risks of failure typical of product development, including the possibility that a product candidate will not be shown to be sufficiently safe and effective for approval by regulatory authorities.

We depend upon key personnel who may terminate their employment with us at any time and we may need to hire additional qualified personnel in order to obtain financing, pursue collaborations or develop or market our product candidates.

The success of our business strategy will depend to a significant degree upon the continued services of key management, technical and scientific personnel and our ability to attract and retain additional qualified personnel and managers, including personnel with expertise in clinical trials, government regulation, manufacturing, marketing and other areas. Competition for qualified personnel is intense among companies, academic institutions and other organizations. If we are unable to attract and retain key personnel and advisors, it may negatively affect our ability to successfully develop, test, commercialize and market our products and product candidates.

Changes in funding for the FDA and other government agencies could hinder our ability to hire and retain key leadership and other personnel, or otherwise prevent new products from being developed or commercialized in a timely manner, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, including for 35 days from December 2018 to January 2019, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

We are dependent on information technology and our systems and infrastructure face certain risks, including from cybersecurity breaches and data leakage.

We rely to a large extent upon sophisticated information technology systems to operate our businesses, some of which are managed, hosted provided and/or used for third-parties or their vendors. We collect, store and transmit large amounts of confidential information (including personal information and pseudonymized information), and we deploy and operate an array of technical and procedural controls to maintain the confidentiality and integrity of such confidential information. A significant breakdown, invasion, corruption, destruction, interruption, or unavailability of critical information technology systems or infrastructure, by our workforce, others with authorized access to our systems or unauthorized persons could negatively impact operations. Hardware, software, or applications we develop or obtain from third parties may contain defects in design or manufacture or other supply chain problems that could unexpectedly compromise our information and network security. The ever-increasing use and evolution of technology, including cloud-based computing, creates opportunities for the unintentional dissemination or intentional destruction of confidential information stored in our or our third-party providers' systems, portable media or storage devices. We could also experience a business interruption, theft of confidential information or reputational damage from industrial espionage attacks, malware or other cyber-attacks (including ransomware), which may compromise our system infrastructure or lead to data leakage, either internally or at our third-party providers. While we have invested in the protection of data and information technology, there can be no assurance that our efforts will prevent service interruptions or security breaches. Any such interruption or breach of our systems could adversely affect our business operations and/or result in the loss of critical or sensitive confidential information or intellectual property, and could result in financial, legal, business and reputational harm to us. In addition, as the regulatory environment related to information security, data collection and use, and privacy becomes increasingly rigorous, with new and constantly changing requirements applicable to our business, compliance with those requirements could also result in additional costs.

We face potential product liability exposure and, if successful claims are brought against us, we may incur substantial liability.

The use of our electroporation equipment and DNA vaccine, DNA immunotherapy and dMAb candidates in clinical trials and the sale of any products for which we obtain marketing approval expose us to the risk of product liability claims. Product liability claims might be brought against us by consumers, healthcare providers, pharmaceutical companies or others selling or otherwise coming into contact with our products. For example, pharmaceutical companies have been subject to claims that the use of some pediatric vaccines has caused personal injuries, including brain damage, central nervous system damage and autism, and these companies have incurred material costs to defend these claims. If we cannot successfully defend ourselves against product liability claims, we could incur substantial liabilities. In addition, regardless of merit or eventual outcome, product liability claims may result in:

•decreased demand for our product candidates;

•impairment of our business reputation;

•withdrawal of clinical trial participants;

•costs of related litigation;

•distraction of management's attention from our primary business;

•substantial monetary awards to patients or other claimants;

•loss of revenues; and

•inability to commercialize our products.

We have obtained product liability insurance coverage for our clinical trials, but our insurance coverage may not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive, and, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability. On occasion, large judgments have been awarded in class action lawsuits based on products that had unanticipated side effects. A successful product liability claim or series of claims brought against us could cause our stock price to decline and, if judgments exceed our insurance coverage, could adversely affect our business.

Healthcare reform measures could hinder or prevent our products' commercial success.

In both the United States and certain foreign jurisdictions there have been, and we anticipate there will continue to be, a number of legislative and regulatory changes to the healthcare system that could impact our ability to sell any of our products profitably. In the United States, the federal government enacted healthcare reform legislation, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA. Among the ACA’s provisions of importance to the pharmaceutical industry are that it:

•imposed an annual excise tax of 2.3% on any entity that manufactures or imports medical devices offered for sale in the United States, with limited exceptions, although the effective rate paid may be lower. However, the 2020 federal spending package permanently eliminated, effective January 1, 2020, this ACA-mandated medical device tax;

•created an annual, nondeductible fee on any entity that manufactures or imports certain specified branded prescription drugs and biologic agents apportioned among these entities according to their market share in some government healthcare programs;

•increased the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price, or AMP;

•created new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics that are inhaled, infused, instilled, implanted or injected;

•expanded eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability;

•expanded the entities eligible for discounts under the Public Health program;

•created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

•established a Center for Medicare & Medicaid Innovation at the Centers for Medicare & Medicaid Services, or CMS, to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending that began on January 1, 2011; and

•created a licensure framework for follow on biologic products.

There remain judicial and Congressional challenges to certain aspects of the ACA. While Congress has not passed comprehensive repeal legislation, it has enacted laws that modify certain provisions of the ACA such as removing penalties, starting January 1, 2019, for not complying with the ACA’s individual mandate to carry qualifying health insurance coverage for all or part of a year. In addition, the 2020 federal spending package permanently eliminated, effective January 1, 2020, the ACA-mandated “Cadillac” tax on high-cost employer-sponsored health coverage, and, effective January 1, 2021, also eliminated the health insurer tax. On June 17, 2021 the U.S. Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. Thus, the ACA will remain in effect in its current form. Further, prior to the U.S. Supreme Court ruling, on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period from February 15, 2021 through August 15, 2021 for purposes of obtaining health insurance coverage through the ACA marketplace. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. It is possible that the ACA will be subject to judicial or Congressional challenges in the future. It is unclear how such challenges, and the healthcare reform measures of the Biden administration will impact the ACA and our business.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. On August 2, 2011, the Budget Control Act of 2011 was signed into law, which, among other things, included reductions to Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute will remain in effect through 2030 with the exception of a temporary suspension from May 1, 2020 through December 31, 2021 unless additional Congressional action is taken. On January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, reduced Medicare payments to several providers, including hospitals, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

Further there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. At the federal level, the Trump administration used several means to propose or implement drug pricing reform, including through federal budget proposals, executive orders and policy initiatives. The Department of Health and Human Services, or HHS, has solicited feedback on some of these measures and implemented others under its existing authority. For example, on July 24, 2020 and September 13, 2020, the Trump administration announced several executive orders related to prescription drug pricing that seek to implement several of the administration’s proposals. As a result, the FDA released a final rule on September 24, 2020, effective November 30, 2020, providing guidance for states to build and submit importation plans for drugs from Canada. Further, on November 20, 2020, HHS finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The implementation of the rule has been delayed by the Biden administration from January 1, 2022 to January 1, 2023 in response to ongoing litigation. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a new safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers, the implementation of which have also been delayed pending review by the Biden administration until March 22, 2021. On November 20, 2020, CMS issued an interim final rule implementing the Trump administration’s Most Favored Nation (MFN) executive order, which would tie Medicare Part B payments for certain physician-administered drugs to the lowest price paid in other economically advanced countries, effective January 1, 2021. On December 28, 2020, the U.S. District Court for the Northern District of California issued a nationwide preliminary injunction against implementation of the interim final rule. On January 13, 2021, in a separate lawsuit brought by industry groups in the U.S. District of Maryland, the government defendants entered a joint motion to stay litigation on the condition that the government would not appeal the preliminary injunction granted in the U.S. District Court for the Northern District of California and that performance for any final regulation stemming from the MFN Model interim final rule shall not commence earlier than sixty (60) days after publication of that regulation in the Federal Register. Based on a recent executive order, the Biden administration expressed its intent to pursue certain policy initiatives to reduce drug prices. Further, at the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. It is also possible that additional governmental action is taken in response to the COVID-19 pandemic.

The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to make and implement healthcare reforms may adversely affect:

•our ability to set a price we believe is fair for our products;

•our ability to generate revenues and achieve or maintain profitability;

•the availability of capital; and

•our ability to obtain timely approval of our products.

If we fail to comply with applicable healthcare regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected.

Certain federal, state, local and foreign healthcare laws and regulations pertaining to fraud and abuse, transparency, patients' rights, and privacy are applicable to our business. The laws that may affect our ability to operate include:

•the federal healthcare program Anti-Kickback Statute, which prohibits, among other things, people from soliciting, receiving or providing remuneration, directly or indirectly, to induce or reward either the referral of an individual, or ordering, or leasing of an item, good, facility or service, for which payment may be made by a federal healthcare program such as Medicare or Medicaid. The intent standard under the federal healthcare program Anti-Kickback Statute was amended by the ACA to a stricter standard such that a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. Further, the ACA codified case law that a claim including items or services resulting from a violation of the federal healthcare program Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act;

•federal civil and criminal false claims laws, including the civil False Claims Act, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent;

•the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which prohibits, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters. Similar to the federal healthcare program Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

•HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information on certain individuals and entities;

•the Physician Payments Sunshine Act, created under the ACA, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with certain exceptions, to report annually to the Centers for Medicare & Medicaid Services, or CMS, information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members, and which, beginning in 2022, will require applicable manufacturers to report information regarding payments and other transfers of value provided during the previous year to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, anesthesiologist assistants, and certified nurse-midwives;

•the Federal Food, Drug, and Cosmetic Act, which among other things, strictly regulates drug product marketing, prohibits manufacturers from marketing drug products for off-label use and regulates the distribution of drug samples;

•the U.S. Foreign Corrupt Practices Act, which, among other things, prohibits companies issuing stock in the U.S. from bribing foreign officials for government contracts and other business;

•state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, state and local laws requiring the registration of pharmaceutical sales and medical representatives, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts; and

•additional state and local laws such as laws in California and Massachusetts, which mandate implementation of compliance programs, compliance with industry ethics codes, and spending limits, and other state and local laws, such as laws in Vermont, Maine, and Minnesota which require reporting to state governments of gifts, compensation, and other remuneration to physicians.

The shifting regulatory environment, along with the requirement to comply with multiple jurisdictions with different compliance and/or reporting requirements, increases the possibility that a company may run afoul of one or more laws.

We will be required to spend substantial time and money to ensure that our business arrangements with third parties comply with applicable healthcare laws and regulations. Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available, which require strict compliance in order to offer protection, it is possible that governmental authorities may conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable healthcare laws. If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to significant penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, imprisonment, integrity and/or other oversight obligations, contractual damages, reputational harm, and the curtailment or restructuring of our operations. Any such penalties could adversely affect our ability to operate our business and our financial results. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management's attention from the operation of our business.

Our business involves the use of hazardous materials and we and our third-party manufacturers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.

Our and our third-party manufacturers' activities involve the controlled storage, use and disposal of hazardous materials, including the components of our product candidates and other hazardous compounds. We and our manufacturers are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials. In the event of an accident, state or federal authorities may curtail the use of these materials and interrupt our business operations. If we are subject to any liability as a result of our or our third-party manufacturers' activities involving hazardous materials, our business and financial condition may be adversely affected.

We have entered into collaborations with Chinese companies and conduct certain research and development activities in China. Uncertainties regarding the interpretation and enforcement of Chinese laws, rules and regulations, a trade war or political unrest in China could materially adversely affect our business, financial condition and results of operations.

We conduct research and development activities in China through our collaboration with Advaccine, which is conducting and funding the Phase 2 trial of INO-4800 in China. In addition, we are party to a license and collaboration agreement with China-based company ApolloBio, pursuant to which ApolloBio has the exclusive right to develop and commercialize VGX-3100 in China, Hong Kong, Macao and Taiwan. The Chinese legal system is a civil law system based on written statutes. Unlike the common law system, prior court decisions may be cited for reference but have limited precedential value. In addition, the Chinese legal system is based in part on government policies and internal rules, some of which are not published on a timely basis or at all, and which may have a retroactive effect. As a result, we may not be aware of our violation of these policies and rules until after the occurrence of the violation. Any administrative and court proceedings in China may be protracted, resulting in substantial costs and diversion of resources and management attention. Since Chinese administrative and court authorities have significant discretion in interpreting and implementing statutory and contractual terms, it may be more difficult to evaluate the outcome of administrative and court proceedings and the level of legal protection we enjoy than in more developed legal systems. Furthermore, we are exposed to the possibility of disruption of our research and development activities in the event of changes in the policies of the United States or Chinese governments, political unrest or unstable economic conditions in China. For example, a trade war could lead to increased costs for clinical materials that are manufactured in China. These interruptions or failures could also impede commercialization of our product candidates and impair our competitive position. Further, we may be exposed to fluctuations in the value of the local currency in China. These uncertainties may impede our ability to enforce the contracts we have entered into and our ability to continue our research and development activities and could materially and adversely affect our business, financial condition and results of operations.

Risks Related to Our Intellectual Property

It is difficult and costly to generate and protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection.

Our commercial success will depend in part on obtaining and maintaining patent, trademark, trade secret, and other intellectual property protection relating to our electroporation equipment and product candidates, as well as successfully defending these intellectual property rights against third-party challenges.

The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. The laws and regulations regarding the breadth of claims allowed in biotechnology patents have evolved over recent years and continues to undergo review and revision, both in the United States and abroad. The biotechnology patent situation outside the United States can be even more uncertain depending on the country. Changes in either the patent laws or in interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property. Accordingly, we cannot predict the breadth of claims that may be allowed or enforced in our licensed patents, our patents or in third-party patents, nor can we predict the likelihood of our patents surviving a patent validity challenge.

The degree of future protection for our intellectual property rights is uncertain, because legal decision-making can be unpredictable, thereby often times resulting in limited protection, which may not adequately protect our rights or permit us to gain or keep our competitive advantage, or resulting in an invalid or unenforceable patent. For example:

•we, or the parties from whom we have acquired or licensed patent rights, may not have been the first to file the underlying patent applications or the first to make the inventions covered by such patents;

•the named inventors or co-inventors of patents or patent applications that we have licensed or acquired may be incorrect, which may give rise to inventorship and ownership challenges;

•others may develop similar or alternative technologies, or duplicate any of our products or technologies that may not be covered by our patents, including design-arounds;

•pending patent applications may not result in issued patents;

•the issued patents covering our products and technologies may not provide us with any competitive advantages or have any commercial value;

•the issued patents may be challenged and invalidated, or rendered unenforceable;

•given the nature of the COVID-19 pandemic, governments in the United States or abroad may prevent us from enforcing patents on our vaccines, which could prevent us from excluding competitors from those markets;

•the issued patents may be subject to reexamination, which could result in a narrowing of the scope of claims or cancellation of claims found unpatentable;

•we may not develop or acquire additional proprietary technologies that are patentable;

•our trademarks may be invalid or subject to a third party's prior use; or

•our ability to enforce our patent rights will depend on our ability to detect infringement, and litigation to enforce patent rights may not be pursued due to significant financial costs, diversion of resources, and unpredictability of a favorable result or ruling.

We depend, in part, on our licensors and collaborators to protect a portion of our intellectual property rights. In such cases, our licensors and collaborators may be primarily or wholly responsible for the maintenance of patents and prosecution of patent applications relating to important areas of our business. If any of these parties fail to adequately protect these products with issued patents, our business and prospects would be harmed significantly.

We also may rely on trade secrets to protect our technology, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. Although we use reasonable efforts to protect our trade secrets, our employees, consultants, contractors, outside scientific collaborators and other advisors may unintentionally or willfully disclose our trade secrets to competitors. Enforcing a claim that a third-party entity illegally obtained and is using any of our trade secrets is expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.

If we or our licensors fail to obtain or maintain patent protection or trade secret protection for our product candidates or our technologies, third parties could use our proprietary information, which could impair our ability to compete in the market and adversely affect our ability to generate revenues and attain profitability.

From time to time, U.S. and other policymakers have proposed reforming the patent laws and regulations of their countries. In September 2011 the America Invents Act (the Act) was signed into law. The Act changed the current “first-to-invent” system to a system that awards a patent to the “first-inventor-to-file” for an application for a patentable invention. The Act also created a procedure to challenge newly issued patents in the patent office via post-grant proceedings and new inter parties reexamination proceedings. These changes may make it easier for competitors to challenge our patents, which could result in increased competition and have a material adverse effect on our product sales, business and results of operations. The changes may also make it harder to challenge third-party patents and place greater importance on being the first inventor to file a patent application on an invention.

If we are sued for infringing intellectual property rights of third parties, it will be costly and time-consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.

Other companies may have or may acquire intellectual property rights that could be enforced against us. If they do so, we may be required to alter our technologies, pay licensing fees or cease activities. If our products or technologies infringe the intellectual property rights of others, they could bring legal action against us or our licensors or collaborators claiming damages and seeking to enjoin any activities that they believe infringe their intellectual property rights.

Because patent applications can take many years to issue, and there is a period when the application remains undisclosed to the public, there may be currently pending applications unknown to us or reissue applications that may later result in issued patents upon which our products or technologies may infringe. There could also be existing patents of which we are unaware that our products or technologies may infringe. In addition, if third parties file patent applications or obtain patents claiming products or technologies also claimed by us in pending applications or issued patents, we may have to participate in interference or derivation proceedings in the United States Patent and Trademark Office to determine priority or derivation of the invention. If third parties file oppositions in foreign countries, we may also have to participate in opposition proceedings in foreign tribunals to defend the patentability of our filed foreign patent applications.

If a third party claims that we infringe its intellectual property rights, it could cause our business to suffer in a number of ways, including:

•we may become involved in time-consuming and expensive litigation, even if the claim is without merit, the third party's patent is invalid or we have not infringed;

•we may become liable for substantial damages for past infringement if a court decides that our technologies infringe upon a third party's patent;

•we may be enjoined by a court to stop making, selling or licensing our products or technologies without a license from a patent holder, which may not be available on commercially acceptable terms, if at all, or which may require us to pay substantial royalties or grant cross-licenses to our patents; and

•we may have to redesign our products so that they do not infringe upon others' patent rights, which may not be possible or could require substantial investment or time.

If any of these events occur, our business could suffer and the market price of our common stock may decline.

Risks Related to an Investment in Our Common Stock

An active trading market for our common stock may not be sustained.

Although our common stock is listed on the Nasdaq Global Select Market, we cannot assure you that an active trading market for our shares will continue to be sustained. If an active market for our common stock is not sustained, it may be difficult for investors in our common stock to sell shares without depressing the market price for the shares or to sell the shares at all.

The price of our common stock has been and may continue to be volatile, and an investment in our common stock could decline substantially in value.

In light of our small size and limited resources, as well as the uncertainties and risks that can affect our business and industry, our stock price has been and may continue to be highly volatile and has been and may in the future be subject to substantial drops, with or even in the absence of news affecting our business. Period to period comparisons are not indicative of future performance. The following factors, in addition to the other risk factors described in this report, and the potentially low volume of trades in our common stock, may have a significant impact on the market price of our common stock, some of which are beyond our control:

•developments concerning any research and development, clinical trials, manufacturing, and marketing efforts or collaborations, particularly developments concerning the prospects of INO-4800 as a potential vaccine candidate against COVID-19;

•fluctuating public or scientific interest in the potential for our vaccines or other product candidates to address COVID-19 or other diseases;

•our announcement of significant acquisitions, strategic collaborations, joint ventures or capital commitments;

•fluctuations in our operating results;

•announcements of technological innovations;

•new products or services that we or our competitors offer;

•changes in the structure of healthcare payment systems;

•the initiation, conduct and/or outcome of intellectual property and/or litigation matters;

•changes in financial or other estimates by securities analysts or other reviewers or evaluators of our business;

•conditions or trends in bio-pharmaceutical or other healthcare industries;

•regulatory developments in the United States and other countries;

•negative perception of gene-based therapy;

•changes in the economic performance and/or market valuations of other biotechnology and medical device companies;

•additions or departures of key personnel;

•sales or other transactions involving our common stock;

•changes in our capital structure;

•sales or other transactions by executive officers or directors involving our common stock;

•changes in accounting principles;

•global unrest, terrorist activities, and economic and other external factors; and

•catastrophic weather and/or global disease pandemics, including COVID-19.

The stock market in general has recently experienced relatively large price and volume fluctuations, particularly in response to the COVID-19 outbreak. In particular, the market prices of securities of smaller biotechnology and medical device companies have experienced dramatic fluctuations that often have been unrelated or disproportionate to the operating results of these companies. Continued market fluctuations could result in extreme volatility in the price of our common stock, which could cause a decline in the value of our common stock. In addition, price volatility may increase if the trading volume of our common stock remains limited or declines.

Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock.

Our amended and restated certificate of incorporation contains provisions that could delay or prevent a change of control of our company or changes in our board of directors that our stockholders might consider favorable. Some of these provisions include:

•the authority of our board of directors to issue shares of undesignated preferred stock and to determine the rights, preferences and privileges of these shares, without stockholder approval;

•all stockholder actions must be effected at a duly called meeting of stockholders and not by written consent; and

•the elimination of cumulative voting.

In addition, we are governed by the provisions of Section 203 of the Delaware General Corporate Law, which may prohibit certain business combinations with stockholders owning 15% or more of our outstanding voting stock. These and other provisions in our amended and restated certificate of incorporation, amended and restated bylaws and Delaware law could make it more difficult for stockholders or potential acquirers to obtain control of our board of directors or initiate actions that are opposed by the then-current board of directors, including to delay or impede a merger, tender offer or proxy contest involving our company. Any delay or prevention of a change of control transaction or changes in our board of directors could cause the market price of our common stock to decline.

We have never paid cash dividends on our common stock and we do not anticipate paying dividends in the foreseeable future.

We have paid no cash dividends on our common stock to date, and we currently intend to retain our future earnings, if any, to fund the development and growth of our business. In addition, the terms of any future debt or credit facility may preclude or limit our ability to pay any dividends. As a result, capital appreciation, if any, of our common stock will be the sole source of potential gain for the foreseeable future.

General Risk Factors

Our quarterly operating results may fluctuate significantly.

We expect our operating results to be subject to quarterly fluctuations. Our net loss and other operating results will be affected by numerous factors, including:

•variations in the level of expenses related to our electroporation equipment, product candidates or future development programs;

•expenses related to corporate transactions, including ones not fully completed;

•addition or termination of clinical trials or funding support;

•any intellectual property infringement lawsuit in which we may become involved;

•any legal claims that may be asserted against us or any of our officers;

•regulatory developments affecting our electroporation equipment and product candidates or those of our competitors;

•debt service obligations on the Notes;

•changes in the fair value of our investments, including investments in affiliated entities;

•our execution of any collaborative, licensing or similar arrangements, and the timing of payments we may make or receive under these arrangements; and

•if any of our products receives regulatory approval, the levels of underlying demand for our products.

If our quarterly operating results fall below the expectations of investors or securities analysts, the price of our common stock could decline substantially. Furthermore, any quarterly fluctuations in our operating results may, in turn, cause the price of our stock to fluctuate substantially. We believe that quarterly comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of our future performance.

Our results of operations and liquidity needs could be materially affected by market fluctuations and general economic conditions.

Our results of operations could be materially affected by economic conditions generally, both in the United States and elsewhere around the world. Concerns over inflation, energy costs, geopolitical issues, global pathogen outbreaks or pandemics, including COVID-19, and the availability and cost of credit have in the past and may continue to contribute to increased volatility and diminished expectations for the economy and the markets going forward. Market upheavals may have an adverse effect on us. In the event of a market downturn, our results of operations could be adversely affected. Our future cost of equity or debt capital and access to the capital markets could be adversely affected, and our stock price could decline. There may be disruption in or delay in the performance of our third-party contractors and suppliers. If our contractors, suppliers and partners are unable to satisfy their contractual commitments, our business could suffer. In addition, we maintain significant amounts of cash and cash equivalents at one or more financial institutions that are in excess of federally insured limits, and we may experience losses on these deposits.

If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.

The trading market for our common stock is influenced by the research and reports that equity research analysts publish about us and our business, and we have limited research coverage by equity research analysts. Equity research analysts may elect not to initiate or continue to provide research coverage of our common stock, and such lack of research coverage may adversely affect the market price of our common stock. Even if we have equity research analyst coverage, we will not have any control over the analysts or the content and opinions included in their reports. The price of our stock could decline if one or

more equity research analysts downgrade our stock or issue other unfavorable commentary or research. If one or more equity research analysts ceases coverage of our company or fails to publish reports on us regularly, demand for our stock could decrease, which in turn could cause our stock price or trading volume to decline.

The issuance of additional stock in connection with financings, acquisitions, investments, our stock incentive plans or otherwise will dilute all other stockholders.

Our certificate of incorporation authorizes us to issue up to 600,000,000 shares of common stock and up to 10,000,000 shares of preferred stock with such rights and preferences as may be determined by our board of directors. Subject to compliance with applicable rules and regulations, we may issue our shares of common stock or securities convertible into our common stock from time to time in connection with a financing, acquisition, investment, our stock incentive plans or otherwise. Any such issuance could result in substantial dilution to our existing stockholders and cause the trading price of our common stock to decline.

We incur significant costs and demands upon management as a result of being a public company.

As a public company listed in the United States, we incur significant legal, accounting and other costs that could negatively affect our financial results. In addition, changing laws, regulations and standards relating to corporate governance and public disclosure, including regulations implemented by the SEC and stock exchanges, may increase legal and financial compliance costs and make some activities more time-consuming. These laws, regulations and standards are subject to varying interpretations and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative expenses and a diversion of management's time and attention from revenue-generating activities to compliance activities. If notwithstanding our efforts to comply with new laws, regulations and standards, we fail to comply, regulatory authorities may initiate legal proceedings against us and our business may be harmed.

Failure to comply with these rules might also make it more difficult for us to obtain some types of insurance, including director and officer liability insurance, and we might be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. The impact of these events could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, on committees of our board of directors or as members of senior management.

Changes in tax laws could adversely affect our business and financial condition.

In December 2017, the Tax Cuts and Jobs Act of 2017 was enacted, which significantly revised the Internal Revenue Code of 1986, as amended, or the Code. The new federal income tax law, among other things, contains significant changes to corporate taxation, including reduction of the corporate tax rate from a top marginal rate of 35 percent to a flat rate of 21 percent, limitation of the tax deduction for interest expense to 30 percent of adjusted earnings (except for certain small businesses), limitation of the deduction for net operating losses to 80 percent of current-year taxable income and elimination of net operating loss carrybacks, one time taxation of offshore earnings at reduced rates regardless of whether they are repatriated, immediate deductions for certain new investments instead of deductions for depreciation expense over time, and modifying or repealing many business deductions and credits (including reducing the business tax credit for certain clinical testing expenses incurred in the testing of certain drugs for rare diseases or conditions). Notwithstanding the reduction in the corporate income tax rate, the overall impact of the federal tax law is uncertain and our business and financial condition could be adversely affected. In addition, it is uncertain if and to what extent various states will conform to the federal tax law.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Not applicable.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

Not applicable.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5. OTHER INFORMATION

Not applicable.

ITEM 6. EXHIBITS

Table of Contents

(a) Exhibits


Exhibit Number						Description of Document






3.1						Certificate of Incorporation with all amendments (incorporated by reference to Exhibit 3.1 of the registrant’s Form S-3 registration statement, filed on July 23, 2014).

3.2						Amended and Restated Bylaws of Inovio Pharmaceuticals, Inc. dated August 10, 2011 (incorporated by reference to Exhibit 3.2 to the registrant’s Form 8-K current report filed on August 12, 2011).

10.1†						Amended and Restated Collaboration and License Agreement dated June 7, 2021, by and between Inovio Pharmaceuticals, Inc. and Advaccine Biopharmaceuticals Suzhou Co., Ltd. (filed herewith).

31.1						Certification of Chief Executive Officer Pursuant to Item 601(b)(31) of Regulation S-K, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).

31.2						Certification of Chief Financial Officer Pursuant to Item 601(b)(31) of Regulation S-K, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).

32.1 *						Certification of the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).*

101.INS						XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document).

101.SCH						Inline XBRL Taxonomy Extension Schema Document

101.CAL						Inline XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF						Inline XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB						Inline XBRL Taxonomy Extension Label Linkbase Document.

101.PRE						Inline XBRL Taxonomy Extension Presentation Linkbase Document.

104						Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

†						Certain confidential portions of this exhibit (indicated by asterisks) were omitted pursuant to applicable regulations.


*			This exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof and irrespective of any general incorporation language in any filings.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.


		Inovio Pharmaceuticals, Inc.

Date:	August 9, 2021	By	/s/ J. JOSEPH KIM
			J. Joseph Kim President, Chief Executive Officer and Director (On Behalf of the Registrant)

Date:	August 9, 2021	By	/s/ PETER KIES
			Peter Kies Chief Financial Officer (Principal Financial and Accounting Officer)

Exhibit 10.1

AMENDED AND RESTATED

COLLABORATION AND LICENSE AGREEMENT

This Amended and Restated Collaboration and License Agreement (the “Agreement”) is entered into as of June 7, 2021 (the “Effective Date”) by and between Inovio Pharmaceuticals, Inc., a corporation organized and existing under the laws of Delaware and having a place of business at 60 W. Germantown Pike, Suite 110, Plymouth Meeting, PA 19462 USA (“Inovio”), and Advaccine Biopharmaceuticals Suzhou Co., Ltd., a corporation having a place of business at B1-308, No. 218 Xinghu Street, Suzhou 214002, Jiangsu Province, China (“Advaccine”). Inovio and Advaccine are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

RECITALS

Whereas, Inovio is currently conducting research and development of the Vaccine (as defined below) and the Product (as defined below);

Whereas, Advaccine is a pharmaceutical company with experience in developing pharmaceutical products in, among other regions, the Advaccine Territory (as defined below);

Whereas, the Parties have been collaborating in co-development of Vaccine since January 2020, including conducting preclinical studies, early stage clinical trials and other development activities in connection with the Product, and desire to continue the collaboration for the Development, Manufacturing and Commercialization of the Product (with each capitalized term as respectively defined below);

Whereas, in furtherance of such collaboration, the Parties wish to co-develop the Product under a Global Phase 3 Study (as defined below) in accordance with the terms of this Agreement;

Whereas, Inovio and Advaccine previously entered into that certain Collaboration and License Agreement (the “Prior Agreement”) dated as of December 31, 2020 (the “Prior Effective Date”) pursuant to which Inovio granted Advaccine the exclusive right to Develop, Manufacture and Commercialize the Product in Greater China (with each capitalized term as respectively defined below);

Whereas, in furtherance of such collaboration, the Parties wish to expand the scope of territories exclusively licensed to Advaccine; and

Whereas, Advaccine and Inovio have entered into that certain Non-exclusive License Agreement, dated as of December 31, 2020 (the “Non-Exclusive License Agreement”), pursuant to which Advaccine granted Inovio a non-exclusive license to certain DNA vaccine manufacturing processes.

Now, Therefore, in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Agreement, the Parties agree as follows:

ARTICLE 1
DEFINITIONS

1.1“Accounting Standards” means (i) for Inovio, the U.S. generally accepted accounting principles (“GAAP”), and (ii) for Advaccine, the International Financial Reporting Standards (“IFRS”) or any other accounting standards it is required to adopt under the applicable Laws, in either case consistently applied.

1.2“Act” shall mean, as applicable, the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§301 et seq., and/or the Public Health Service Act, 42 U.S.C. §§262 et seq., as such may be amended from time to time.

1.3“Advaccine Patents” means any Patents that claim Advaccine Inventions.

1.4“Advaccine Territory” means, collectively, (a) mainland China, Taiwan, Hong Kong and Macau (“Greater China”) and (b) the countries listed on Schedule 1.4 attached hereto (each of mainland China, Taiwan, Hong Kong, Macau and the countries listed on Schedule 1.4, a “Region”).

1.5“Adverse Risk” means any risk of an adverse effect on the Development, procurement or maintenance of Regulatory Approval, Manufacture or Commercialization of the Products.

1.6“Affiliate” means, with respect to a particular Party, a Person that controls, is controlled by or is under common control with such Party. For the purposes of this definition, the word “control” (including, with correlative meaning, the terms “controlled by” or “under common control with”) means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of such entity, whether by the ownership of fifty percent (50%) or more of the voting stock of such entity, or by contract or otherwise. For clarity, once a Person ceases to be an Affiliate of a Party, then, without any further action, such Person shall cease to have any rights, including license and sublicense rights, under this Agreement by reason of being an Affiliate of such Party.

1.7“Anti-Corruption Laws” means laws, regulations, or orders prohibiting the provision of a financial or other advantage for a corrupt purpose or otherwise in connection with the improper performance of a relevant function, including without limitation, to the extent applicable, the Corruption of Foreign Public Officials Act (CFPOA), the US Foreign Corrupt Practices Act (FCPA), the UK Bribery Act 2010, and similar laws governing corruption and bribery, whether public, commercial or both, to the extent applicable.

1.8“Array” means device arrays used in combination with the Inovio Device.

1.9“Biosimilar Product” means, with respect to a particular Product that has received Regulatory Approval for a particular indication in a particular Region and is being marketed and sold by Advaccine or any of its Affiliates or Sublicensees in the applicable Region, a biologic product that (a) is sold in such region by a Third Party that is not a sublicensee of Advaccine or its Affiliate, and where such Third Party did not purchase or acquire such product in a chain of distribution that included any of Advaccine or its Affiliates or sublicensees, and (b) has received Regulatory Approval (with all references in the definitions for Biosimilar Product and Regulatory Approval to the “Product” to be deemed references to such biologic product) in such Region for the same indication as the applicable Product as a “bioequivalent,” “biosimilar” or similar designation of interchangeability by the applicable Regulatory Authority in such Region pursuant to an expedited or abbreviated approval process, where (i) such Product is the reference product in such Region, and (ii) such Regulatory Approval referred to or relied on the approved Marketing Authorization Application for such Product held by Advaccine or its Affiliate or Sublicensee in such Region or the data contained or incorporated by reference in such approved Marketing Authorization Application for such Product in such Region.

1.10“Business Day” means a day other than Saturday, Sunday or any day that banks in Suzhou, China; Plymouth Meeting, PA; or New York City, New York, are required or permitted to be closed.

1.11“Calendar Quarter” means each successive period of three (3) consecutive calendar months ending on March 31, June 30, September 30, or December 31.

1.12“Calendar Year” means, for the first Calendar Year, the period beginning on the Effective Date and ending on December 31, 2021, and for each Calendar Year thereafter each 12-month period commencing on January 1, and ending on December 31, except that the last Calendar Year will commence on January 1 of the year in which this Agreement expires or terminates and end on the effective date of such expiration or termination.

1.13“Change of Control” means with respect to either Party: (a) the sale of all or substantially all of such Party’s assets or business relating to this Agreement (other than to an Affiliate of such Party); (b) a merger, reorganization or consolidation involving such Party in which the voting securities of such Party outstanding immediately prior thereto cease to represent at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization or consolidation; or (c) a Person, or group of Persons, acting in concert acquire more than fifty percent (50%) of the voting equity securities or management control of such Party.

1.14“Clinical Supply Costs” means Inovio’s Manufacturing Expenses for the clinical supply of Product in connection with the Global Phase 3 Study.

1.15“Clinical Trial” means any clinical testing of a pharmaceutical or biologic product in human subjects.

1.16“CMC Information” means Information related to the chemistry, manufacturing and controls of the Product, as specified by the FDA, NMPA and other applicable Regulatory Authorities.

1.17“Commercialization” means all activities undertaken before and after obtaining Regulatory Approvals relating specifically to the pre-launch, launch, promotion, detailing, medical education and medical liaison activities, marketing, pricing, reimbursement, sale, and distribution of the Products, including strategic marketing, sales force detailing, advertising, market the Product support, all customer support, the Product distribution and invoicing and sales activities; provided, however, “Commercialization” shall exclude any activities relating to the Manufacture of the Product. “Commercialize” and “Commercializing” shall have the correlative meanings.

1.18“Commercially Reasonable Efforts” means, with respect to either Party’s obligations under this Agreement, the carrying out of such obligations with a level of efforts and resources consistent with the commercially reasonable practices of a similarly situated company in the pharmaceutical industry for the active and diligent commercialization of a similarly situated branded pharmaceutical product as the Product at a similar stage of commercialization, taking into account efficacy, safety, patent and regulatory exclusivity, anticipated or approved labeling, present and future market potential, competitive market conditions, the profitability of the product in light of pricing and reimbursement issues, and all other relevant factors. It is understood that in fulfilling any obligation to use Commercially Reasonable Efforts in this Agreement, a Party shall not take into account (i) any other pharmaceutical product such Party is then researching, developing, manufacturing or commercializing outside the scope of this Agreement, (ii) the payments required to be made by such Party to the other Party under this Agreement, (iii) such Party’s access to sufficient personnel, capital or resources to conduct its responsibilities hereunder in accordance with the foregoing standards or (iv) political considerations.

1.19“Common Technical Document” or “CTD” means a set of specifications for application dossier adopted by the ICH for organizing applications of pharmaceuticals for human use to regulatory authorities.

1.20“Competing Product” means any biological or pharmaceutical product, other than the Vaccine or the Product, that is intended for the prevention of the disease caused by SARS-CoV-2.

1.21“Confidential Information” of a Party means any and all Information of such Party or its Affiliates that is disclosed to the other Party or its Affiliates under this Agreement, whether in oral, written, graphic, or electronic form. In addition, all Information disclosed by a Party or its Affiliates pursuant to the mutual non-disclosure agreement between Beijing Advaccine Biotechnology Co., Ltd. and Inovio dated January 27, 2020 (the “Confidentiality Agreement”) shall be deemed to be Confidential Information of such Party disclosed hereunder; provided, however, that any use or disclosure of any such Information that is authorized under

Article 12 shall not be restricted by, or be deemed a violation of, the Confidentiality Agreement. For clarity, Inovio Licensed Know-How shall be deemed Confidential Information of Inovio.

1.22“Control” means, with respect to any material, Information, Patent or other intellectual property right, possession of the right, whether directly or indirectly, and whether by ownership, license, or otherwise, to grant a license, sublicense, or other right to or under, such material, Information, Patent, or intellectual property right without violating the terms of any existing agreement or other arrangement with any Third Party; provided that, with respect to any material, Information, Patent or other intellectual property right obtained by Inovio after the Prior Effective Date from a Third Party, Inovio shall be deemed to Control such material, Information, Patent or other intellectual property right only if it possesses the right to grant such license, sublicense, or other right thereto without being obligated to pay any royalties or other consideration therefor, unless Advaccine agrees in advance of any grant of rights thereto to pay such royalties or other consideration.

1.23“Cover” means, with respect to a Patent and a Product, that the Manufacture, use, offer for sale, sale or import of such Product by an unlicensed Third Party would infringe a Valid Claim in such Patent; provided, however, that in determining whether a claim of a pending Patent application would be infringed, it shall be treated as if issued in the form then currently being prosecuted. “Covered” and “Covering” shall have the correlative meanings.

1.24“CTA” means a Clinical Trial Application which provides comprehensive information about the investigational medicinal product(s) and planned trial, enabling Regulatory Authorities to assess the acceptability of conducting the applicable study.

1.25“Data” means all data, including CMC Information, non-clinical data, preclinical data and clinical data, generated by or on behalf of a Party or its Affiliates or their respective Sublicensees (in the case of Advaccine) or licensees, including Inovio Partners (in the case of Inovio), pursuant to activities conducted under this Agreement. For clarity, Data does not include any patentable Inventions.

1.26“Development” means all activities conducted relating to preclinical and clinical trials, toxicology testing, statistical analysis, publication and presentation of study results with respect to the Products, and the reporting, preparation and submission of regulatory applications (including any CMC Information) for obtaining, registering and maintaining Regulatory Approval of the Products; provided, however, “Development” shall exclude any activities relating to the Manufacture of the Product. “Develop” and “Developing” shall have the correlative meanings.

1.27“Development Costs” means R&D Out-Of-Pocket Costs, R&D Internal Costs, and Clinical Supply Costs.

1.28“Drug Substance” means bulk drug substance that is represented for use in a drug that, when used in the Manufacturing of a drug, becomes an active pharmaceutical ingredient.

1.29“EMA” means the European Medicines Agency or any successor entity.

1.30“FDA” means the U.S. Food and Drug Administration or any successor entity.

1.31“Field” means all prophylactic and therapeutic use in humans.

1.32“First Commercial Sale” means with respect to a Region, the first sale of a Product in such Region to a Third Party by or on behalf of Advaccine, its Affiliates or Sublicensees after Regulatory Approval has been obtained in such Region.

1.33“Fiscal Year” means Advaccine’s fiscal year that starts on January 1 and ends on December 31.

1.34“FTE” means employees of Inovio or its Affiliates, excluding personnel performing administrative and corporate functions (including human resources, finance, legal and investor relations).

1.35“FTE Costs” means, with respect to any period, the FTE Rate multiplied by the number of hours of FTEs expended by Inovio during such period.

1.36“FTE Rate” means a rate of [***] per hour.

1.37“GCP” or “Good Clinical Practices” means the then-current requirements, standards, practices and procedures promulgated or endorsed by the FDA as set forth in 21 Code of Federal Regulations Parts 50, 54, 56, and 312 and the guidelines entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related regulatory requirements imposed by the FDA, and comparable regulatory standards, practices and procedures promulgated by the NMPA or other Regulatory Authority applicable in the Advaccine Territory, as they may be updated from time to time, including applicable quality guidelines promulgated under the ICH.

1.38“Global Development Costs” means those certain Development Costs incurred on or after [***] in connection with either Party’s conduct of the Global Phase 3 Study in accordance with the Global Phase 3 Study Plan. For clarity, Global Development Costs excludes (i) any costs or expenses incurred by Advaccine in connection with its activities under the Global Phase 3 Study in Greater China, and (ii) any costs or expenses incurred by Inovio, its Affiliates, Sublicensees or Third Parties that are solely related to its activities in connection with the performance of the Clinical Trial in the US under the Global Phase 3 Study. For clarity, Global Development Costs shall include costs incurred by Inovio in the US in connection with the conduct of Global Phase 3 Study that are not specific to the dosing of patients in the Clinical Trial in the US, such as trial management and operations costs, pharmacovigilance costs, on-going stability costs, regulatory costs, and analytical testing costs.

1.39“Global Phase 3 Study” means that certain Phase 3 Clinical Trial described in Schedule 1.39, attached hereto, to be conducted by Inovio and Advaccine (other than in Greater China, where such Phase 3 Clinical Trial will be conducted by Advaccine). For clarity, Global

Phase 3 Study does not include any Clinical Trials not specifically described in Global Phase 3 Study Plan and does not include any Clinical Trial that will be conducted by Each Party independently. For additional clarity, Global Phase 3 Study does include any Clinical Trial conducted by a Global Purchasing Entity.

1.40“Global Phase 3 Study Plan” means that certain development plan for the Global Phase 3 Study set forth in Schedule 1.40, attached hereto, , as such development plan may be updated or amended from time to time in accordance with this Agreement.

1.41“GLP” or “Good Laboratory Practices” means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and comparable regulatory standards promulgated by NMPA or other Regulatory Authority applicable to the Advaccine Territory, as may be updated from time to time, including applicable quality guidelines promulgated under the ICH.

1.42“GMP” means (a) the good manufacturing practices required by the FDA and set forth in the FDCA or FDA regulations (including without limitation 21 U.S.C. 351 and 21 CFR Parts 210 and 211), policies, guidances or guidelines, or any applicable equivalent within a regulatory jurisdiction, including, without limitation, any applicable current good manufacturing practices requirements and pharmaceutical industry standards for the manufacture and testing of investigational pharmaceutical materials in force from time-to-time in the European Union (including, without limitation, Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice), the relevant national implementations of these rules and any relevant national and European Commission and EMA guidance and, in particular, Annex 13 of the Guide to Good Manufacturing Practice entitled “Manufacture of investigational medicinal products”, as updated and amended from time-to-time, in each case in effect at any time during the term of this Agreement, for the manufacture, handling and testing of investigational pharmaceutical products; (b) the corresponding requirements of each applicable Regulatory Agency or other governmental authority, and (c) any other guidances, procedures, practices, arrangements, additions or clarifications, as the Parties may agree in writing from time-to-time.

1.43“Government Official” means (a) any official or employee of any Governmental Authority, or any department, agency, or instrumentality thereof (including without limitation commercial entities owned or controlled, directly or indirectly, by a Governmental Authority), (b) any political party or official thereof, or any candidate for political office, or (c) any official or employee of any public international organization.

1.44“Governmental Authority” means any multi-national, national, federal, state, local, municipal, provincial or other governmental authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).

1.45“ICH” means International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

1.46“Information” means any Data, results, technology, business or financial information or information of any type whatsoever, in any tangible or intangible form, including know-how, copyrights, trade secrets, practices, techniques, methods, processes, inventions, developments, specifications, formulae, software, algorithms, marketing reports, expertise, technology, test data (including pharmacological, biological, chemical, biochemical, clinical test data and data resulting from non-clinical studies), CMC Information, stability data and other study data and procedures.

1.47“Initiation” means, with respect to a Clinical Trial, enrollment of the first patient in such Clinical Trial. “Initiate” and “Initiating” shall have the correlative meanings.

1.48“Inovio Device” means Inovio’s proprietary electroporation device CELLECTRA® 2000 and CELLECTRA® 3PSP, including any improvements and variants thereof Controlled by Inovio, and the associated Arrays, applicators and components.

1.49“Inovio Licensed Know-How” means any and all Information (including Data and Regulatory Materials) that (a)(i) is Controlled by Inovio or its Affiliates as of the Prior Effective Date with respect to Greater China and as of the Effective Date outside of Greater China or (ii) becomes Controlled by Inovio or its Affiliates during the Term, and (b) is necessary for the Development, Manufacture, or Commercialization of the Vaccine and/ or the Product in the Field in the Advaccine Territory. For clarity, Inovio Licensed Know-How shall include Inovio’s interest in any Information included in Inovio Inventions and Joint Inventions.

1.50“Inovio Licensed Patents” means any and all Patents that (a)(i) are Controlled by Inovio or its Affiliates as of the Prior Effective Date with respect to Greater China and as of the Effective Date outside of Greater China or (ii) become Controlled by Inovio or its Affiliates during the Term, and (b) Cover the Vaccine and/or the Product in the Field in the Advaccine Territory. Inovio Licensed Patents include the Patents listed in Exhibit A and Inovio’s interest in any Joint Patents that may be filed during the Term.

1.51“Inovio Product-Specific Licensed Patents” means any Inovio Licensed Patents specifically claiming the composition of matter of, or the method of making or using, the Vaccine and/the Product in the Field in the Advaccine Territory. The Parties acknowledge and agree that the Patents listed in Exhibit A are Inovio Product-Specific Licensed Patents.

1.52“Inovio Technology” means the Inovio Licensed Know-How and Inovio Licensed Patents.

1.53“Inovio Territory” means the world except for the Advaccine Territory.

1.54“Inovio US Trial” means a Phase 3 Clinical Trial or any other trials that are equivalent or similar to a Pivotal Clinical Trial, as requested by the FDA or at its own initiative, designed or intended to ascertain efficacy of the Product in a larger population, to be conducted by Inovio, itself or by its Affiliate or a Third Party in the U.S. or any other jurisdictions in the Inovio Territory.

1.55“Inventions” means any inventions and/or discoveries, including processes, manufacture, composition of matter, Information, methods, assays, designs, protocols, and formulas, and improvements or modifications thereof, patentable or otherwise, that are generated, developed, conceived or reduced to practice (constructively or actually) by or on behalf of a Party or its Affiliates or their respective Sublicensees (in the case of Advaccine) or licensees, including Inovio Partners (in the case of Inovio) (a) pursuant to activities conducted under this Agreement, or (b) in connection with the Development, Manufacture, and Commercialization of the Product, in each case of (a) and (b), including all rights, title and interest in and to the intellectual property rights therein and thereto; provided, however, that Inventions shall exclude Data.

1.56“Joint Patents” means any Patents that claim Joint Inventions.

1.57“Laws” means all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, municipal, city or other political subdivision, domestic or foreign.

1.58“Manufacture” and “Manufacturing” mean activities directed to manufacturing, processing, filling, finishing, packaging, labeling, quality control, quality assurance testing and release, post-marketing validation testing, inventory control and management, storing and transporting the Vaccine or the Product (as well as the Array), including oversight and management of vendors therefor.

1.59“Manufacturing Cost” means, with respect to a particular drug product supplied by Inovio pursuant to Section 7.1: (a) if Inovio or its Affiliate Manufactures the applicable drug product, the actual manufacturing cost of such drug product (as determined in accordance with U.S. GAAP consistently applied with its other products); or (b) if a Third Party Manufactures such drug product, the actual transfer price paid by Inovio or its Affiliate to such Third Party for the Manufacture of such drug product without any additional mark-up; in each case of (a) and (b), excluding the external costs of insurance and transportation, import and export taxes and fees, and similar charges, for such drug product.

1.60“Manufacturing Expenses” means, with respect to a particular unit of Product or Inovio Device used in connection with the Global Phase 3 Study: (a) if Inovio or its Affiliate Manufactures the applicable Product or Inovio Device, the actual manufacturing cost of such Product or Inovio Device (as determined in accordance with U.S. GAAP consistently applied with its other products); or (b) if a Third Party Manufactures such Product or Inovio Device, the actual transfer price paid by Inovio or its Affiliate to such Third Party for the Manufacture of such Product or Inovio Device without any additional mark-up; in each case of (a) and (b), excluding the external costs of insurance and transportation, import and export taxes and fees, and similar charges, for such Product or Inovio Device.

1.61“Marketing Authorization Application” or “MAA” means new drug application, biologics license application, or other marketing authorization application to the

appropriate Regulatory Authority for approval to market a Product, but excluding pricing approvals.

1.62“Net Sales” means the gross amounts billed or invoiced by Advaccine, its Affiliates and their respective Sublicensees for sales of the Products to Third Parties, less the following deductions to the extent reasonable, customary, and actually allowed and taken with respect to such sales:

(a)trade, cash or quantity discounts not already reflected in the amount invoiced, to the extent related to the gross amount billed or invoiced;

(b)price reductions, rebates and administrative fees (including those paid or credited to pharmacy benefit managers, governmental authorities or otherwise) (provided that, such administrative fees shall not be in excess, in the aggregate of [***] of Net Sales with respect to any given Calendar Quarter);

(c)shipping costs, including freight, insurance and other transportation charges or costs incurred in shipping of the Products to Third Parties (provided that, such shipping costs shall not be in excess of [***] of Net Sales with respect to any given Calendar Quarter);

(d)sales, use, excise, value-added or similar taxes, customs duties and other governmental fees, charges and surcharges imposed on the sale of the Products;

(e)amounts repaid or credited by reason of rejections, defects, recalls or returns;

(f)amounts paid or credited for wholesaler chargebacks; and

(g)any receivables that have been included in gross sales and are deemed to be uncollectible according to Accounting Standards (any such bad debt deductions shall be applied to Net Sales in the period in which such receivables are written off) (provided that, the amount of such receivables shall not be in excess of [***] of Net Sales with respect to any given Calendar Quarter).

Notwithstanding the foregoing, amounts received or invoiced by Advaccine, its Affiliates, or their respective Sublicensees for the sale of the Product among Advaccine, its Affiliates or their respective Sublicensees shall not be included in the computation of Net Sales hereunder unless the purchasing entity is the end-user. For purposes of determining Net Sales, the Product shall be deemed to be sold when billed or invoiced. Net Sales shall be accounted for in accordance with standard Advaccine practices for operation by Advaccine, its Affiliates or their respective Sublicensees, as practiced in the Advaccine Territory, but in any event in accordance with Accounting Standards consistently applied in the Advaccine Territory. For clarity, a particular item may only be deducted once in the calculation of Net Sales. Notwithstanding anything to the contrary in the foregoing, to the extent any amounts deducted pursuant to subsections (d) or (g) above are subsequently recovered by Advaccine, its Affiliates,

or their respective Sublicensees during the Term, such recovered amounts shall be deemed “Net Sales” for the subsequent Calendar Quarter; provided that, if no royalties are owed by Advaccine for such subsequent Calendar Quarter pursuant to Section 8.4, Advaccine shall promptly refund such recovered amounts to Inovio.

The transfer of any Product to an Affiliate, Sublicensee, or other Third Party (x) in connection with the research, development or testing of a Product (including, without limitation, the conduct of Clinical Trials), (y) for purposes of distribution as promotional samples, or (z) at nominal cost for indigent or similar public support or compassionate use programs, will not, in any case, be considered a Net Sale of a Product under this Agreement.

With respect to any transfer of any Product in the Advaccine Territory for any substantive consideration other than monetary consideration on arm’s length terms, for the purposes of calculating the Net Sales under this Agreement, such Product shall be deemed to be sold exclusively for money at the average Net Sales price charged to Third Parties for cash sales in the Advaccine Territory during the applicable reporting period (or if there were only de minimus cash sales in the Advaccine Territory, at the fair market value as determined by comparable markets).

Advaccine, its Affiliates, and their respective Sublicensees shall sell the Product as a standalone product and will not sell the Product as a part of a bundle with other products or offer packaged arrangements to customers that include the Product, except with Inovio’s prior written consent.

In the event that a Product is sold by Advaccine, its Affiliates or their respective Sublicensees in a relevant Region as part of a Combination Product, where “Combination Product” means any unified dose (e.g., not a kit of two separate and distinct drug dosage forms that are priced and sold separately) of pharmaceutical product which is comprised of (x) a Product and (y) other therapeutically active compound(s) not licensed by Inovio to Advaccine hereunder (collectively the “Other Products”), Net Sales of such Product, for the purposes of determining royalty payments, shall be determined by the subsections below:

(i) [***]

(ii) [***]

1.63“NMPA” means the National Medical Products Administration of the People’s Republic of China, formerly known as the China Food and Drug Administration, or any successor agency or authority thereto.

1.64“Patents” means (a) pending patent applications, issued patents, utility models and designs; (b) reissues, substitutions, confirmations, registrations, validations, re-examinations, additions, continuations, continued prosecution applications, continuations-in-part, or divisions of or to any of the foregoing; and (c) extensions, renewals or restorations of any of the foregoing by existing or future extension, renewal or restoration mechanisms, including supplementary protection certificate, patent term additions, patent term extensions or the equivalent thereof.

1.65“Person” means an individual, corporation, partnership, limited liability company, limited partnership, trust, business trust, association, joint stock company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, Governmental Authority or any other form of entity not specifically listed herein.

1.66“Phase 2 Clinical Trial” means any human clinical trial of a Vaccine conducted mainly to test the effectiveness of chemical or biologic agents or other types of interventions for purposes of identifying the appropriate dose for a Phase 3 Clinical Trial for a particular indication or indications that would satisfy the requirements of 21 CFR § 312.21(b) or its non-United States equivalents. A “Phase 2/3 Clinical Trial” shall be deemed to be a Phase 2 Clinical Trial with respect to the portion of that clinical trial that is regarded as its Phase 2 component, in accordance with the applicable protocol.

1.67“Phase 3 Clinical Trial” means any human clinical trial of a Vaccine designed to: (i) establish that such Product is safe and efficacious for its intended use; (ii) define warnings, precautions and adverse reactions that are associated with the Product in the dosage range to be prescribed; and (iii) support regulatory approval of such Product, that would satisfy the requirements of 21 CFR § 312.21(c) or its non-United States equivalents. A “Phase 2/3 Clinical Trial” shall be deemed to be a Phase 3 Clinical Trial with respect to the portion of that clinical trial that is regarded as its Phase 3 component, in accordance with the applicable protocol.

1.68“Pivotal Clinical Trial” means a pivotal study in human patients with a defined dose or a set of defined doses of the Product designed or intended to ascertain efficacy and safety of the Product for the purpose of enabling the preparation and forming the primary basis for submission of a Marketing Authorization Application for the Product to the competent Regulatory Authority in a Region of the Advaccine Territory, which may be a Phase 2 Clinical Trial or a Phase 3 Clinical Trial.

1.69“Product(s)” means any pharmaceutical/biological product in any form comprising the Vaccine, with or without an Inovio Device.

1.70“Proper Conduct Practices” means, Advaccine, its Affiliates and Sublicensees, and each of their Representatives not, directly or indirectly, (a) making, offering, authorizing, providing or paying anything of value in any form, whether in money, property, services or otherwise to any Government Official, or other Person charged with similar public or quasi-public duties, or to any customer, supplier, or any other Person, or to any employee thereof, or failing to disclose fully any such payments in violation of the laws of any relevant jurisdiction to (i) obtain favorable treatment in obtaining or retaining business for it or any of its Affiliates, (ii) pay for favorable treatment for business secured, (iii) obtain special concessions or for special concessions already obtained, for or in respect of it or any of its Affiliates, in each case which would have been in violation of any applicable Laws, (iv) influence an act or decision of the recipient (including a decision not to act) in connection with the Person’s or its Affiliate’s business, (v) induce the recipient to use his or her influence to affect any government act or decision in connection with the Person’s or its Affiliate’s business or (vi) induce the recipient to violate his or her duty of loyalty to his or her organization, or as a reward for having done so;

(b) engaging in any transactions, establishing or maintaining any fund or assets in which it or any of its Affiliates shall have proprietary rights that have not been recorded in the books and records of it or any of its Affiliates; (c) making any unlawful payment to any agent, employee, officer or director of any Person with which it or any of its Affiliates does business for the purpose of influencing such agent, employee, officer or director to do business with it or any of its Affiliates; (d) violating any provision of applicable Anti-Corruption Laws; (e) making any payment in the nature of bribery, fraud, or any other unlawful payment under the applicable Laws of any jurisdiction where it or any of its Affiliates conducts business or is registered; or, (f) if such Person or any of its Representatives is a Government Official, improperly using his or her position as a Government Official to influence the award of business or regulatory approvals to or for the benefit of such Person, its Representatives or any of their business operations, or failing to recuse himself or herself from any participation as a Government Official in decisions relating to such Person, its Representatives or any of their business operations.

1.71 “R&D Out-Of-Pocket Costs” means amounts actually paid by Inovio or Affiliates of Inovio to Third Parties for goods and services required in order for Inovio to conduct the Global Phase 3 Study.

1.72“R&D Internal Costs” means all FTE Costs of Inovio and Affiliates of Inovio incurred directly in connection with the conduct of the Global Phase 3 Study, but for clarity R&D Internal Costs shall not include FTEs associated with the Manufacture of the Product, which shall be calculated and shared, if applicable, based on the Manufacturing Expenses and not separately charged as FTEs.

1.73“Regulatory Approval” means any and all approvals (including marketing authorization approvals, supplements, amendments, pre- and post-approvals, and pricing and reimbursement approvals), licenses, registrations or authorizations of any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, that are necessary for the Manufacture, distribution, marketing, importation, exportation, use or commercial sale of a Product in a given country or regulatory jurisdiction.

1.74“Regulatory Authority” means, in a particular country or jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval in such country or jurisdiction.

1.75“Regulatory Materials” means regulatory applications (including CTA and MAA), submissions, notifications, communications, correspondence, registrations, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Develop, Manufacture, market, sell or otherwise Commercialize the Products in a particular country or jurisdiction.

1.76“Representatives” means, as to any Person, such Person’s Affiliates and its and their successors, controlling Persons, directors, officers and employees.

1.77“Sublicensee” means a Third Party that has received a license or other right under the Inovio Technology in accordance with Section 2.1(c), but shall not include (i) any Third Party wholesaler or distributor engaged for the sale of the Product (even if such wholesaler or distributor is granted a right or license to sell Product) provided that such wholesaler or distributor does not make any royalty, milestone, profit share or other payment to Advaccine or its Affiliate based on such wholesaler’s or distributor’s sale of the Product; or (ii) any Third Party contract research organization or manufacturer providing services to Advaccine or its Affiliate (even if such contract research organization or manufacturer is granted a right or license to make the Vaccine or the Product). For clarity, the gross invoiced price for sale of the Product to any wholesaler, distributor, contract research organization or manufacturer described above shall be included in Net Sales.

1.78“Third Party” means any Person other than a Party or an Affiliate of a Party.

1.79“U.S. Dollar” means a U.S. dollar, and “US$” shall be interpreted accordingly.

1.80“U.S.” or “USA” means the United States of America, including all possessions and territories thereof.

1.81“Vaccine” means INO-4800, which includes the DNA plasmid identified as pGX9501, encoding the Spike protein of SARS-CoV-2.

1.82“Valid Claim” means a claim (including a process, use, or composition of matter claim) of (a) an issued and unexpired patent that has not (i) irretrievably lapsed or been revoked, dedicated to the public or disclaimed or (ii) been held invalid, unenforceable or not patentable by a court, governmental agency, national or regional patent office or other appropriate body that has competent jurisdiction, which holding, finding or decision is final and unappealable or unappealed within the time allowed for appeal, or (b) a pending patent application that has been prosecuted in good faith pending for no more than seven (7) years since its priority date and has not been abandoned or finally disallowed without the possibility of appeal.

1.83“Year” means any period of twelve (12) consecutive months.

1.84Additional Definitions: The following table identifies the location of definitions set forth in various Sections of the Agreement:


Defined Terms			Section
Accused Party			9.5
Advaccine			Preamble
Advaccine Housemarks			9.6(b)
Advaccine Indemnitees			11.1
Advaccine Inventions			9.1(d)(ii)
Advaccine Product Mark			9.6(a)
Advaccine Sublicense Agreement			2.1(c)


Agreement			Preamble
Alliance Manager			3.1
Bankruptcy Laws			15.13
Claims			11.1
Clinical Manufacturing Technology Transfer Agreement			7.1(c)
Clinical Supply Agreement			7.1(a)
Combination Product			1.62
Commercialization Plan			6.2(a)
Confidentiality Agreement			1.21
Development Plan			4.3
Divestiture			2.5
Effective Date			Preamble
Enforcing Party			9.4(c)
Executive Officer			14.1
First Supplemental Development Plan			4.3
GAAP			1.1
Greater China			1.4
IFRS			1.1
Indemnified Party			11.3
Indemnifying Party			11.3
Infringement			9.4(a)
Infringement Action			9.5
Initial Development Plan			4.3
Inovio			Preamble
Inovio Device Commercial Supply Agreement			7.2(a)
Inovio Indemnitees			11.2
Inovio Inventions			9.1(d)(i)
Inovio Partner			2.2
Insolvency Event			13.5
Insolvent Party			15.13
Joint Inventions			9.1(d)(iii)
Joint Steering Committee			3.2(a)
Losses			11.1
Non-Exclusive License Agreement			Recitals
Non-Insolvent Party			15.13
Other Products			1.62
Party			Preamble
PDF			15.12
Pharmacovigilance Agreement			5.8
Prior Agreement			Recitals


Prior Effective Date			Recitals
Product Materials			4.8
Region			1.4
Remedial Action			5.9
Royalty Term			8.4(b)
SEC			12.3(c)
Securities Regulators			12.2(c)
SIAC			14.2
SIAC Rules			14.2
Step-In Rights			9.2(d)
Tax Withholding			8.9(b)
Term			13.1
VAT			8.9(c)
Working Group			3.5

ARTICLE 2
LICENSE

2.1 License to Advaccine.

(a)License Grant. Subject to the terms and conditions of this Agreement, Inovio hereby grants Advaccine an exclusive (even as to Inovio except as provided in Section 2.1(b) below) license, with the right to sublicense (solely as provided in Section 2.1(c)), under the Inovio Technology, to Develop, Manufacture and have Manufactured (solely in accordance with Section 7.2), distribute, market, promote, sell, have sold, offer for sale, import, label, package and otherwise Commercialize the Products in the Field in the Advaccine Territory. For clarity, no rights shall be granted to Advaccine under this Section 2.1(a), with respect to the Development, Manufacture or Commercialization of any product containing or using for administration an Inovio Device without the Vaccine. For further clarity and unless otherwise agreed in Section 2.1(d), no rights shall be granted to Advaccine under this Section 2.1(a) with respect to the Manufacture of the Inovio Device other than the right to Manufacture the Arrays in the Advaccine Territory. As consideration for the foregoing license and access to and transfers of know-how under this Agreement, Advaccine will make certain payments to Inovio as set out in, and subject to the terms and conditions of, Article 8. Notwithstanding the foregoing to the contrary, in the event that Advaccine [***] and the [***]Payment Cap has been reached, Inovio will have the right to convert the foregoing license to a non-exclusive license for all countries in the Advaccine Territory (outside of Greater China), unless Advaccine agrees to pay to Inovio its fifty percent (50%) share of Development Costs pursuant to Section 8.1(b) that are in excess of the [***]Payment Cap, subject to Section 8.1(b)(ii).

(b)Inovio Retained Rights. Notwithstanding the exclusive rights granted to Advaccine in Section 2.1(a), Inovio and its Affiliates shall retain the following:

(i)the right to practice the Inovio Technology within the scope of the license granted to Advaccine under Section 2.1(a) in order to perform, or have performed by a Third Party contractor, Inovio’s obligations under this Agreement;

(ii)the right to Manufacture or have Manufactured the Products anywhere in the world for sale and use in the Inovio Territory, provided that Inovio shall obtain prior written consent, not to be unreasonably withheld, from Advaccine before Manufacturing or having Manufactured the Products in the Advaccine Territory using any rights granted to Inovio under the Non-Exclusive License Agreement for sale and use in the Inovio Territory;

(iii)the right to practice and license the Inovio Technology outside the scope of the license granted to Advaccine under Section 2.1(a); and

(iv)the right to conduct activities under the Global Phase 3 Study Plan in the Advaccine Territory (excluding in Greater China) in accordance with the terms of this Agreement.

(c)Sublicense Rights. Advaccine shall not have the right to grant sublicenses of the license granted in Section 2.1(a) without Inovio’s express prior written consent, except that Advaccine may grant such sublicense without Inovio’s consent to its Affiliates. Upon receiving approval from Inovio for the grant of a sublicense to a Third Party, Advaccine shall, within thirty (30) days after granting any such sublicense, notify Inovio of the grant of such sublicense and provide Inovio with a true and complete copy of the sublicense agreement (which may have financial information and other confidential information redacted, provided that such redacted information is not reasonably necessary for Inovio to assess compliance of the sublicense agreement with this Section 2.1(c)) (each, a “Advaccine Sublicense Agreement”). Each Advaccine Sublicense Agreement shall be consistent with the terms and conditions of this Agreement, and Advaccine shall be solely responsible for all of its Sublicensees’ activities and any and all failures by its Sublicensees to comply with the applicable terms of this Agreement. Without limiting the foregoing, each Advaccine Sublicense Agreement shall include the following additional terms and conditions:

(i)the Sublicensee shall be bound by non-use and non-disclosure obligations no less stringent than those set forth in this Agreement;

(ii)the Sublicensee shall not have any right to grant further sublicenses to the Inovio Technology (excluding sublicenses to Third Party contractors, including distributors and wholesalers);

(iii)the Sublicensee shall not have any right to prosecute or maintain or enforce any Inovio Licensed Patents; and

(iv)the Sublicensee shall assign or license to Advaccine all Data and Inventions generated by such Sublicensee, and shall grant Advaccine all of the rights necessary for Advaccine to fulfill its obligations under Sections 9.1(a) and 9.1(d).

(d)Additional License. Inovio hereby agrees to expand the license granted to Advaccine under Section 2.1 for Advaccine, by itself or through any of its Affiliates or a Third Party, to conduct the Phase 3 Clinical Trial in the Inovio Territory at Advaccine’s own cost and expense for the purpose of obtaining the Regulatory Approval of the Product in the Advaccine Territory, in the event of (i) unless a Phase 3 Clinical Trial in the Inovio Territory has already been completed, a Change of Control of Inovio, where the acquirer of Inovio, by itself or through any of its Affiliates or a Third Party, is developing, manufacturing or commercializing any Competing Product for the Advaccine Territory; (ii) an official request by any Regulatory Authority in the Advaccine Territory; (iii) the occurrence of such circumstances as described in Section 4.2; or (iv) otherwise upon mutual agreement of the Parties; provided, however, that Inovio shall have the right to review and approve the protocols and design of such Phase 3 Clinical Trial. Inovio hereby agrees to expand the license granted to Advaccine under Section 2.1 for Advaccine to have the Inovio Device Manufactured in the U.S. or any other mutually agreed upon country by a Third Party contract manufacturer for use with the Product in the Advaccine Territory in the event of the occurrence of an Insolvency Event of Inovio.

2.2 Inovio Partner. Inovio has the right, in its sole discretion, to enter into one or more agreements with Third Parties and grant such Third Parties the right to Develop, Manufacture and/or Commercialize the Products in one or more countries in the Inovio Territory (each such Third Party, a “Inovio Partner”); provided that (a) Inovio shall remain solely responsible for any Inovio Partner’s activities, and (b) the grant of such rights to such Inovio Partner shall not affect Inovio’s obligations under the Agreement. So long as such Inovio Partner(s) is not actively developing or commercializing any Competing Product in the Advaccine Territory, (i) Inovio shall have the right (but not the obligation) to fulfill any of its obligations under this Agreement through Inovio Partner(s), including Inovio’s obligations under Article 3, and (ii) Inovio shall have the right to disclose to Inovio Partner(s) all Information solely regarding the Products, including all Regulatory Materials relating thereto, disclosed by Advaccine to Inovio under this Agreement, for use by Inovio Partner(s) in their Development, Manufacture and Commercialization of the Product in the Inovio Territory; provided, however, that (A) all such Information disclosed to Inovio Partner(s) by Inovio shall be deemed the Confidential Information of Advaccine, and (B) any Inovio Partner(s) that receive such information shall be obligated to abide by restrictions on disclosure and use substantially similar to the provisions set forth in Section 12.1 and Inovio shall remain responsible for the Inovio Partner(s)’ performance of such obligations and compliance with such restrictions.

2.3 Negative Covenant. Advaccine covenants that, except as explicitly set forth in this Agreement, it will not, and will not permit any of its Affiliates or Sublicensees to, use or practice any Inovio Technology outside the scope of the license granted to it under Section 2.1(a).

2.4 No Implied Licenses. Except as explicitly set forth in this Agreement, neither Party shall be deemed by estoppel or implication to have granted the other Party any license or other right to any intellectual property of such Party.

2.5 Exclusivity.

(a)Exclusivity Covenant. During the Term, Advaccine hereby covenants not to, itself or through any Affiliate or Third Party, Develop, Manufacture or Commercialize any Competing Product in the Field in the Advaccine Territory. For clarity, the foregoing restrictions shall not apply to (i) internal research and internal non good laboratory practices preclinical work by either Party; and (ii) any Development, Manufacture and Commercialization of any Combination Product by Advaccine in the Advaccine Territory upon mutual agreement of the Parties.

(b)Advaccine Change of Control. In the event that, in connection with an Advaccine Change of Control, Advaccine or any of its Affiliates obtains or holds the rights to a Competing Product that would cause Advaccine to be in breach of Section 2.5(a), then upon written notice to Inovio within thirty (30) days after such rights are first obtained, Advaccine shall elect one of the following: (A) to terminate this Agreement pursuant to Section 13.2, in which case such notice will serve as notice of termination under Section 13.2; or (B) to (or have its Affiliate) sell, exclusively license or transfer rights to the Competing Product to a Third Party without Advaccine or any of its Affiliates receiving a continuing share of profit, royalty payments, or other economic interest in the success of such Competing Product in the Advaccine Territory (a “Divestiture”), in which case Advaccine or any of its Affiliates shall, or shall cause the applicable entity to, complete the Divestiture of such Competing Product within twelve (12) months from the date of such Advaccine Change of Control, in which case the conduct of activities with respect to such Competing Product by Advaccine or any of its Affiliates during such 12-month period shall not be deemed a breach of Advaccine’s exclusivity obligations under Section 2.5, provided that such activities with respect to such Competing Product during such 12-month period are conducted independently of the activities conducted under this Agreement and no Inovio Technology or Advaccine Inventions is used in the conduct of such activities.

2.6 Transfer of Inovio Licensed Know-How. Inovio shall provide Advaccine with complete and accurate copies of the Inovio Licensed Know-How directly applicable to the Vaccine, the Product and the Arrays to the extent expressly provided for in Exhibit B and in accordance with the timeline specified therein. The JSC shall establish a reasonable process and schedule for the transfer of additional Inovio Licensed Know-How related to the Vaccine, the Product and the Array as required for the filing of an MAA in the Advaccine Territory and any other necessary Inovio Licensed Know-How that subsequently comes into existence and becomes Controlled by Inovio or its Affiliates during the Term. Inovio shall reasonably cooperate with Advaccine in providing Advaccine only with copies of such Inovio Licensed Know-How directly applicable to the Vaccine, the Product and the Array (but not the Inovio Device) in accordance with the process and schedule agreed upon through the JSC.

ARTICLE 3
GOVERNANCE

3.1 Alliance Managers. Each Party has prior to the Effective Date appointed a representative having the appropriate qualifications, including a general understanding of pharmaceutical development, manufacturing, and commercialization issues, to act as its alliance

manager under this Agreement (the “Alliance Manager”). The Alliance Managers shall serve as the primary contact points between the Parties for the purpose of providing each Party with information on the progress and results of Advaccine’s Development, Manufacturing, and Commercialization of the Products. The Alliance Managers shall also be primarily responsible for facilitating the flow of information and otherwise promoting communication, coordination and collaboration between the Parties with respect to the Products. Each Party may replace its Alliance Manager at any time upon written notice to the other Party.

3.2 Joint Steering Committees.

(a)Formation; Purpose. The Parties have established a joint steering committee under the Prior Agreement (the “Joint Steering Committee” or “JSC”) which JSC shall be responsible for the overall coordination and oversight of the Parties’ activities under this Agreement. The role of the JSC shall be:

(i)to review, discuss and coordinate the overall strategy for the Development, Manufacturing, and Commercialization of the Products in the Field in the Advaccine Territory, including related regulatory activities;

(ii)to review, discuss and approve the Initial Development Plan and any proposed amendments or revisions to the Development Plan, including the First Supplemental Development Plan and those with respect to clinical Development activities set forth in Section 4.4(b);

(iii)to review and discuss (but not approve) the Commercialization Plan and any proposed amendments or revisions to such plan, and review and discuss (but not approve) the Commercialization of the Products in the Field in the Advaccine Territory (including any pricing strategy with respect to the Products);

(iv)to coordinate the Commercialization of the Products in the Advaccine Territory and Inovio Territory to ensure consistent global marketing of the Products in the Field;

(v)to review, discuss and approve the Global Phase 3 Study Plan and any proposed amendments or revisions thereto; and

(vi)to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined by the Parties in writing.

(b)Members. The JSC shall be comprised of an equal number of representatives from each Party. Each Party’s representatives shall be an officer or employee of such Party or its Affiliate having sufficient seniority within the applicable Party to make decisions arising within the scope of the JSC’s responsibilities. In addition, at least one of Advaccine’s JSC representatives must be someone whose job responsibilities within Advaccine include active involvement in the development and implementation of Advaccine’s Development

(including regulatory) strategy with respect to the Products in the Field in the Advaccine Territory (at all times that Advaccine or its Affiliate or sublicensee is conducting such Development) or Advaccine’s Commercialization strategy with respect to the Products in the Field in the Advaccine Territory (at all times that Advaccine or its Affiliate or sublicensee is conducting such Commercialization), and each of Advaccine’s JSC representatives must have up-to-date knowledge of Advaccine’s ongoing and planned Development (including regulatory) and Commercialization activities with respect to the Products in the Field in the Advaccine Territory (at all times that Advaccine is conducting such activities). Each Party shall initially appoint two (2) representatives to the JSC. The JSC may change its size from time to time by unanimous consent of its representatives, and each Party may replace its representatives at any time upon written notice to the other Party. Each Party shall appoint one (1) of its representatives on the JSC to act as the co-chairperson. The role of the co-chairpersons shall be to convene and preside at the JSC meetings and to ensure the circulation of meeting agendas at least five (5) Business Days in advance of JSC meetings and the preparation of meeting minutes and any pre-read materials in accordance with Section 3.2(c), but the co-chairpersons shall have no additional powers or rights beyond those held by other JSC representatives. Employees or consultants of either Party that are not representatives of the Parties on the JSC may attend meetings of the JSC, provided that such attendees shall not vote or otherwise participate in the decision-making process of the JSC and are subject to obligations of confidentiality substantially similar to the provisions set forth in Section 12.1.

(c)Meetings. The JSC shall meet at least once per Calendar Quarter during the Term, unless the Parties mutually agree in writing to a different frequency for such meetings. Either Party may also call a special JSC meeting (by videoconference or teleconference) by at least ten (10) Business Days prior written notice to the other Party in the event such Party reasonably believes that a significant matter must be addressed prior to the next regularly scheduled meeting, and such Party shall provide the JSC no later than ten (10) Business Days prior to the special meeting with materials reasonably adequate to enable an informed decision. The JSC may meet in person, by videoconference or by teleconference. All JSC meetings shall be conducted in English, and all communications, reports and records by and between the Parties under this Agreement shall be in English. The co-chairpersons shall alternate responsibility for preparing reasonably detailed written minutes of the JSC meetings that reflect, without limitation, all material decisions made at such meetings. The co-chairpersons (or their designees) shall send draft meeting minutes to each representative of the JSC for review and approval within ten (10) Business Days after the JSC meeting. Such minutes shall be deemed approved unless one or more JSC representatives object to the accuracy of such minutes within ten (10) Business Days of receipt.

(d)Decision Making. The JSC shall strive to seek consensus in its actions and decision making process and all decisions by the JSC shall be made by consensus, with each Party having collectively one (1) vote in all decisions. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC, the representatives of the Parties cannot reach an agreement as to such matter (to the extent that such matter requires the agreement of the Parties hereunder) within ten (10) Business Days after such matter was brought to the JSC for resolution or after such matter has been referred to the JSC, then,

Advaccine’s Executive Officer shall have the final decision making authority with respect to such matter within the JSC’s authority; provided, however, that Inovio’s Executive Officer shall have the final decision making authority with respect to such matter within the JSC’s authority that relates to the Global Phase 3 Study (including any amendment to the Global Phase 3 Study Plan) and Inovio’s Executive Officer shall have the right in their sole discretion to veto any decision by Advaccine reasonably likely to result in Adverse Risk on the Inovio Technology, or the safety or efficacy of the Product, or the Development or Commercialization of the Product in the Inovio Territory, including any other global Clinical Trial of Product or Regulatory Approval of any Product in the Inovio Territory, and provided, further, that (i) any decision to Develop, Manufacture or Commercialize the Product as a Combination Product in the Advaccine Territory will require the mutual agreement of the Parties, and (ii) Advaccine shall not have the right, by virtue of its decision-making authority, to cause Inovio to violate the terms of any agreement with a Third Party, or cause Inovio to violate any applicable Laws, ethical requirement, or intellectual property right of any Third Party, and Advaccine’s exercise of its decision-making authority shall be subject to the limitations set forth in Section 3.3; provided, that Inovio shall provide Advaccine with an explanation as to why any such decision of Advaccine would cause Inovio to violate the terms of any agreement with a Third Party, or cause Inovio to violate any applicable Laws, ethical requirement, or intellectual property right of any Third Party.

For clarity, the JSC shall be a forum for discussing, but shall not have any decision-making authority with respect to, Inovio’s Development of the Product in the Inovio Territory, and Inovio shall have full control and authority over the Development, Commercialization of the Product in the Inovio Territory.

3.3 Limitation of JSC Authority. The JSC shall only have the powers expressly assigned to it in this Article 3 and elsewhere in this Agreement and shall not have the authority to: (a) modify or amend the terms and conditions of this Agreement; (b) waive or determine either Party’s compliance with the terms and conditions of under this Agreement; or (c) decide any issue in a manner that would conflict with the express terms and conditions of this Agreement.

3.4 Discontinuation of the JSC. The activities to be performed by the JSC shall solely relate to governance under this Agreement, and are not intended to be or involve the delivery of services. The JSC shall continue to exist until the first to occur of: (a) the Parties mutually agree to disband the JSC; or (b) Inovio provides written notice to Advaccine of its intention to disband and no longer participate in the JSC. Thereafter, the JSC shall have no further obligations under this Agreement and each Party shall designate a contact person for the exchange of information relevant to activities that would have been performed by the JSC under this Agreement and decisions of the JSC shall be decisions as between the Parties, subject to the other terms and conditions of this Agreement.

3.5 Working Groups. From time to time, the JSC may establish and delegate duties of the JSC to sub-committees or directed teams (each, a “Working Group”) on an “as-needed” basis to oversee particular projects or activities; provided that in any case neither Party shall be required by the Working Group to assume any responsibility, financial or otherwise, beyond those agreed to in writing by such Party, in particular pursuant to each Party’s respective obligations under this Agreement. Each such Working Group shall be constituted and shall operate as the JSC

determines. Working Groups may be established on an ad hoc basis for purposes of a specific project or on such other basis as the JSC may determine. Each Working Group and its activities shall be subject to the oversight, review and approval of, and shall report to, the JSC. In no event shall the authority of the Working Group exceed that of the JSC. All decisions of a Working Group shall be by consensus. Any disagreement between the members of a Working Group shall be referred to the JSC for resolution.

ARTICLE 4
DEVELOPMENT

4.1 Overview; Diligence of Advaccine. Subject to the terms and conditions of this Agreement (including the diligence obligations set forth below), Advaccine shall be solely responsible for the Development of the Products in the Field in the Advaccine Territory, at its own cost and expense (except as otherwise expressly set forth herein), including (except as set forth in Section 4.8) all non-clinical and clinical studies and collection of CMC Information, as necessary to obtain the Regulatory Approval for the Products in any Region in the Advaccine Territory. Advaccine shall maintain adequate funding and use Commercially Reasonable Efforts to Develop and obtain the Regulatory Approval for the Products in the Field in each Region in the Advaccine Territory. Without limiting the generality of the foregoing, Advaccine shall use Commercially Reasonable Efforts to conduct its Development activities under and in accordance with the Development Plan, as well as Manufacturing activities related to such Development, as set forth in the Initial Development Plan.

4.2 Diligence of Inovio. Inovio shall (i) use Commercially Reasonable Efforts to Develop and obtain the Regulatory Approval for the Products in the Field in the United States, and shall provide all reasonable assistance and cooperation to assist and support Advaccine, at Advaccine’s sole cost and expense, as specified in this Agreement, the Development Plan or as reasonably requested by Advaccine from time to time, in obtaining the Regulatory Approval for the Products (as well as the Inovio Device and the Array for use in connection with the Products) in the Advaccine Territory; (ii) use Commercially Reasonable Efforts, together with Advaccine, to design the Global Phase 3 Study Plan and conduct the activities associated with the Global Phase 3 Study in accordance with the Global Phase 3 Study Plan and applicable Laws; and (iii) use Commercially Reasonable Efforts to achieve the first dosing of the Global Phase 3 Study [***]. Except for circumstances provided in Section 2.1(d) (i), (ii) and (iv), in the event that, within twelve (12) months from the Prior Effective Date, the Inovio US Trial is not Initiated or Inovio decides not to conduct or is not required to conduct the Inovio US Trial, Inovio shall inform Advaccine thereof in writing. In such an event, Advaccine may elect to conduct a Phase 3 Clinical Trial in the Inovio Territory at its own cost and expense for the purpose of obtaining Regulatory Approval of the Product in the Advaccine Territory, subject to Section 2.1(d); provided, however, that Inovio shall have the right to review and approve the protocols and design of such Phase 3 Clinical Trial.

4.3 Development Plan. Advaccine has prepared and submitted to the JSC an initial, summary plan and budget for research and Development of the Vaccine and the Products in the Field in Greater China (the “Initial Development Plan”) within thirty (30) days after the Prior Effective Date, and the Initial Development Plan has been reviewed and approved by the JSC. Within ninety (90) days after the Prior Effective Date, Advaccine has prepared and submitted to the JSC a detailed plan containing the strategy, activities, study designs, timeline, study material needs (including

Inovio Devices and the Vaccine) and budget for research and Development of the Vaccine and the Products in the Field in Greater China (the “First Supplemental Development Plan,” and together with the Initial Development Plan and any subsequent updates pursuant to this Section 4.3, the “Development Plan”). The First Supplemental Development Plan included among other things, all material non-clinical and clinical studies, CMC Information collection activities and regulatory activities with respect to the Vaccine and the Products to be conducted by or on behalf of Advaccine or its Affiliates or their respective Sublicensees in Greater China. From time to time during the Term (but at least once per Fiscal Year), Advaccine shall prepare amendments and updates, as appropriate, to the then-current Development Plan (including for Development activities (other than with respect to the Global Phase 3 Study) in the Advaccine Territory (both in and outside of Greater China)), and shall submit such amendments and updates to the JSC in accordance with Section 4.4. For further clarity, if there are no amendments or updates to the then-current Development Plan that are applicable in a Fiscal Year, Advaccine’s sole responsibility under this Section 4.3 during such Fiscal Year shall be to inform Inovio that the then-current Development Plan is up to date. Advaccine shall be solely responsible for the day-to-day conduct of Development within the Advaccine Territory and all decisions associated therewith, except for the Global Phase 3 Study as otherwise provided in this Agreement.

4.4 Other Development Activities.

(a)Pre-Clinical Development. Advaccine may conduct pre-clinical studies to generate and obtain Data that is reasonably useful for the Development of any Product in the Field in the Advaccine Territory, provided that Advaccine shall promptly amend the Development Plan to include such pre-clinical studies and submit such amendment to the JSC for review and approval.

(b)Clinical Development. If Advaccine wishes to conduct any Clinical Trials for the Development of any Product in the Field other than as set forth in the First Supplemental Development Plan in the Advaccine Territory, Advaccine may propose an amendment to the Development Plan to include such Clinical Trials and submit such amendment to the JSC for review and approval. If and upon receipt of such proposal, the JSC shall promptly (but in any event within thirty (30) days) review and decide on whether to approve such proposal. Upon the JSC’s approval of such amendment, such Clinical Trials shall be included in the amended Development Plan and Advaccine may conduct such Clinical Trials at its own cost. Advaccine shall ensure that any Clinical Trials conducted in the Advaccine Territory, whether by itself or through a subcontractor pursuant to Section 4.10, are conducted only at medical facilities that are qualified and registered with the NMPA or any other applicable Regulatory Authority. For clarity, Advaccine shall not conduct any Clinical Trials of any Product outside of the Field.

(c)Global Phase 3 Study Participation. Subject to oversight by the Parties through the JSC, Inovio will use Commercially Reasonable Efforts to conduct the Global Phase 3 Study jointly with Advaccine in both the Inovio Territory and the Advaccine Territory (other than Greater China) in accordance with the Global Phase 3 Study Plan, and, to the extent expressly set forth in the Global Phase 3 Study Plan, Advaccine will jointly participate in the Global Phase 3 Study with Inovio (except for the Clinical Trial in the US) to the extent the activities to be conducted by Advaccine in support of such Global Phase 3 Study are included in

the Global Phase 3 Study Plan. Advaccine and Inovio will equally share the Global Development Costs in accordance with Section 8.1(b). For clarity, Inovio will be solely responsible for conducting the Clinical Trial in the US. For clarity, the current Global Phase 3 Study Plan does not include Clinical Trial sites in Greater China, where Advaccine will be solely responsible for conducting Development activities in Greater China. To the extent permissible by the applicable Laws or the Regulatory Authorities, Advaccine shall be identified and acknowledged as Inovio’s collaboration partner or co-developer with respect to Vaccine. In the event that Inovio enters into an agreement with a Global Purchasing Entity that authorizes such Global Purchasing Entity to conduct a portion of the Global Phase 3 Study in the Advaccine Territory (other than Greater China) in accordance with Section 6.6, then Inovio will work directly with such Global Purchasing Entity regarding such portion of the Global Phase 3 Study and will update the JSC with respect to such Development activities. For clarity, the Development activities conducted by such Global Purchasing Entity will not be subject to the approval of the JSC. The foregoing provisions shall apply mutatis mutandis in the event that Advaccine enters into an agreement with a Global Purchasing Entity that authorizes such Global Purchasing Entity to conduct a portion of the Global Phase 3 Study in the Inovio Territory.

(d)Cooperation. As agreed to between the Parties, Inovio may provide such technical assistance and cooperation to Advaccine as Advaccine may reasonably request, at Advaccine’s sole cost and expense, as necessary or reasonably useful for Advaccine to Develop or Commercialize the Products in the Field in the Advaccine Territory. The foregoing provisions shall apply mutatis mutandis in the event that Inovio reasonably requests technical assistance and cooperation from Advaccine, which will be at Inovio’s sole cost and expense, as necessary or reasonably useful for Inovio to Develop or Commercialize the Products in the Field in the Inovio Territory.

4.5Development Records.

(a)Advaccine shall maintain complete, current and accurate records of all activities (and all Data and other Information resulting from such activities) conducted with respect to Products by Advaccine, its Affiliates and their respective Sublicensees in the Advaccine Territory. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Advaccine shall document all non-clinical studies and Clinical Trials for the Products in formal written study records according to applicable Laws, including applicable national and international guidelines such as ICH, GCP and GLP, and shall, at Inovio’s reasonable request, provide Inovio English translations thereof (to the extent prepared and originated in a language other than English) at Inovio’s sole cost and expense. Subject to provisions in Section 4.9, Inovio shall have the right to review and copy such records at reasonable times and to obtain access to the original to the extent necessary or useful for regulatory or patent purposes and for legal proceedings in accordance with this Agreement.

(b)Inovio shall maintain, and shall cause its Affiliate, licensees or contractors to maintain complete, current and accurate records of all activities (and all Data and other Information resulting from such activities) in connection with the Global Phase 3 Study

according to the Global Phase 3 Study Plan and applicable Laws, including applicable national and international guidelines such as ICH, GCP and GLP. Advaccine shall have the right to, upon reasonable prior written notice and by itself or through its designees, examine such records, review and copy such records and to obtain access to the original to the extent necessary, and audit the conduct of the Global Phase 3 Study conducted by Inovio, its Affiliates, licensee or Third Party Contractors, solely for the purpose of verifying the compliance of the Global Phase 3 Study with the Global Phase 3 Study Plan and the applicable Laws.

4.6 Development Reports. Advaccine shall keep Inovio reasonably informed as to the progress and results of Advaccine’s, its Affiliates’ and their respective Sublicensees’ Development activities (including prompt reporting of available clinical Data). Without limiting the foregoing, at each regularly scheduled JSC meeting, Advaccine shall provide Inovio with a reasonably detailed written report summarizing its Development activities performed since the last JSC meeting and the results thereof, as reasonably sufficient to enable Inovio to determine Advaccine’s compliance with its diligence obligations under Section 4.1; provided that, even if the JSC does not hold a meeting in one or more Calendar Quarters, Advaccine shall provide such written report to Inovio at least once every Calendar Quarter. At such JSC meeting, the Parties shall discuss the status, progress and results of Advaccine’s, its Affiliates’ and their respective Sublicensees’ Development activities. Advaccine shall promptly respond to Inovio’s reasonable questions or requests for additional information relating to such Development activities. In addition, within thirty (30) days after the end of each Fiscal Year, Advaccine shall provide Inovio with a detailed written annual report regarding the progress of its Development activities and any results therefrom.

4.7 Development Reports for Global Phase 3 Study. Inovio shall keep Advaccine reasonably informed as to the progress and results of Inovio’s Development activities under the Global Phase 3 Study (including prompt reporting of available clinical Data). Without limiting the foregoing, at each JSC meeting during the conduct of the Global Phase 3 Study, Inovio shall provide Advaccine with a reasonably detailed written report summarizing its activities performed since the last JSC meeting and the results thereof, as reasonably sufficient to enable Advaccine to determine Inovio’s compliance with its diligence obligations under Section 4.2; provided that, even if the JSC does not hold any regularly scheduled meeting during the course of the Global Phase 3 Study, Inovio shall provide such written report to Advaccine at least once every Calendar Quarter. At such JSC meeting, the Parties shall discuss the status, progress and results of the Global Phase 3 Study, and Inovio shall promptly respond to Advaccine’s reasonable questions or requests for additional information relating to such activities. In addition and to the extent applicable, within thirty (30) days after the end of each Fiscal Year, Inovio shall provide Advaccine with a detailed written report regarding the progress of the Global Phase 3 Study and any results therefrom.

4.8 Data Exchange. In addition to Inovio’s obligation with respect to the transfer of Inovio Licensed Know-How set forth under Section 2.6 and each Party’s adverse event and safety Data reporting obligations pursuant to Section 5.8, but subject to the remainder of this Section 4.8 and Section 4.9, each Party shall, at its sole cost and expense, promptly provide the other Party with copies of any Data and Regulatory Materials related to the Vaccine or the Products generated by or on behalf of such Party or its Affiliates or Sublicensees in the performance of Development activities hereunder that would be reasonably necessary for the Development, Manufacture and Commercialization of the

Vaccine or the Products in the Field in the other Party’s respective territory (the “Product Materials”). The JSC may establish reasonable policies to effectuate the exchange of additional Product Materials between the Parties. Advaccine shall have the right to use the data provided by Inovio hereunder for the purpose of obtaining and maintaining Regulatory Approval for and Commercializing the Product in the Field in the Advaccine Territory. Inovio shall have the right to use the data provided by Advaccine hereunder for the purpose of obtaining and maintaining Regulatory Approval for and Commercializing the Product in the Inovio Territory.

4.9 Clinical Trial Data. The Parties acknowledge and agree that certain government approval or filing may be required in the Advaccine Territory before certain Data generated from the Clinical Trials in the Advaccine Territory may be provided to or otherwise made available to Inovio or its designee. The Parties agree to use their Commercially Reasonable Efforts to collaborate with each other and with Third Parties in obtaining such approval or filing in the most efficient manner as permitted by the applicable Laws.

4.10 Subcontractors. Advaccine, upon prior express written consent from Inovio, shall have the right to engage subcontractors to conduct any activities necessary for Development or Manufacturing (subject to the terms of Article 7) of the Products, including but not limited to non-clinical studies, Clinical Trials, CMC activities, and regulatory services for the Products, under this Agreement, provided that such subcontractors (a) are bound by written obligations of confidentiality, non-use and compliance with applicable Laws, including Proper Conduct Practices, consistent with this Agreement and have agreed in writing to assign to Advaccine all Data, Information, inventions or other intellectual property generated by such subcontractor in the course of performing such subcontracted work, (b) are capable of producing Data (including non-clinical Data, clinical Data and CMC Information, as applicable) acceptable to the NMPA, the FDA and the EMA (and other applicable Regulatory Authorities in the Advaccine Territory, the United States or the European Union) and (c) as applicable, with respect to matters covered by Article 7, meet the specifications and requirements thereunder. Advaccine shall remain responsible for any obligations that have been delegated or subcontracted to any subcontractor, and shall be responsible for the performance of its subcontractors.

ARTICLE 5
REGULATORY MATTERS

5.1 Regulatory Responsibilities.

(a)Subject to the terms and conditions of this Agreement, Advaccine will be responsible, at its sole cost and expense, for the conduct of all regulatory activities required to obtain and maintain Regulatory Approval of the Products (including the Inovio Device and the Arrays for use in connection with the Products) in the Field in the Advaccine Territory, including the preparation and submission of all Regulatory Materials and all communications and interactions with Regulatory Authorities, as necessary to obtain Regulatory Approval for the Products in any Region in the Field in the Advaccine Territory. Advaccine shall be responsible for filing each CTA in the Field in the Advaccine Territory for each Product. Advaccine shall be responsible for filing each MAA in the Field in the Advaccine Territory for each Product in Advaccine’s name. The Development Plan shall include the regulatory strategy for obtaining

Regulatory Approval of the Products in the Field in the Advaccine Territory. Advaccine shall use Commercially Reasonable Efforts to carry out its regulatory obligations for the Products pursuant to such strategy. Notwithstanding the foregoing to the contrary, Inovio and Advaccine will be jointly responsible for, through the JSC, with Inovio taking the lead in the conduct of all regulatory activities required to obtain and maintain, in connection with Global Phase 3 Study, Regulatory Approval of the Products (including the Inovio Device and the Arrays for use in connection with the Products) in the Field in the Advaccine Territory outside of Greater China until completion of the Global Phase 3 Study. Upon completion of the Global Phase 3 Study, Inovio will promptly transfer to Advaccine (including its Affiliate or Sublicensee) all Regulatory Materials related to the Global Phase 3 Study that are specific to the Advaccine Territory. In the event that any of such Regulatory Materials cannot be transferred to Advaccine (including its Affiliate or their respective Sublicensee), or Advaccine (including its Affiliate or Sublicensee) is not permitted to apply for the MAA of the Product (including the Inovio Device and the Arrays for use in connection with the Products) in reliance on such Regulatory Materials in any Region outside Greater China, due to the requirements of the applicable Laws or the Regulatory Authorities in such Region, Inovio shall continue to hold such Regulatory Materials and to conduct all the necessary regulatory activities to obtain the MAA of the Product (including the Inovio Device and the Arrays for use in connection with the Products) in such Region in the name of itself, its Affiliate or Sublicensee but for the benefit of Advaccine (and subject to reimbursement by Advaccine of Inovio’s costs and expenses with respect thereto); and Inovio shall, subject to reimbursement by Advaccine of Inovio’s costs and expenses, continue working with Advaccine to provide all necessary support to facilitate and achieve the transfer of the Regulatory Materials or the MAA of the Product (including the Inovio Device and the Arrays for use in connection with the Products) to Advaccine (including its Affiliates or their respective Sublicensees) as contemplated in this paragraph.

(b)Inovio shall provide all reasonable assistance and cooperation to Advaccine as Advaccine may reasonably request, at Advaccine’s sole cost and expense, during the Term of this Agreement, with respect to the satisfaction of Advaccine’s obligations under Section 5.1(a), including (i) in connection with the preparation of Regulatory Materials, (ii) (A) making available competent personnel to attend regulatory meetings or join such meetings by teleconference and (B) providing documentation within Inovio’s possession and control, in each case as requested by Regulatory Authorities at Advaccine’s cost, and (iii) providing Advaccine with additional Product Materials in the Inovio Territory as requested by Regulatory Authorities in the Advaccine Territory within a reasonable timeframe commensurate with the volume of Advaccine’s reasonable request. In the event that Inovio believes that such requests are not reasonable or are otherwise burdensome to Inovio, then such matter shall be promptly submitted to the JSC for review and discussion.

5.2 Regulatory Information Sharing. Advaccine shall (a) provide Inovio with copies of the original documents (in the electronic format in which it has been prepared by Advaccine) of draft package inserts, CTA and CTD, and, at Inovio’s request, together with English translations (to the extent originated by Advaccine in Chinese), for Inovio’s review and comment, in connection with obtaining or maintaining any MAA approval for the Products in the Field in the Advaccine Territory, prior to the submission of such documents to the Regulatory Authority in the Advaccine Territory; and

(b) shall keep Inovio informed of any material verbal or written communication or question relating to the Products received by Advaccine from the Regulatory Authority in the Advaccine Territory. Except as required by applicable Law or with Inovio’s express written permission, Advaccine, its Affiliates and Sublicensees shall not submit any Regulatory Materials to, or communicate with, any Regulatory Authority in the Inovio Territory regarding any Products; provided, that if such submission or communication is required by applicable Law, Advaccine shall, if legally permitted, promptly notify Inovio in writing of such requirement and the content of such submission or communication. Except to the extent in connection with the exercise of its retained rights under Section 2.1(b), Inovio, its Affiliate and Sublicensees shall not submit any Regulatory Materials to, or communicate with, any Regulatory Authority in the Advaccine Territory regarding any Products. If such submission or communication is required by applicable Law, Inovio shall, if legally permitted, promptly notify Advaccine in writing of such requirements and the content of such submission or communication. Notwithstanding the foregoing to the contrary, the Parties shall jointly prepare the Regulatory Materials and Inovio shall have the right to lead the submission of such Regulatory Materials with Regulatory Authorities in the Advaccine Territory (other than in Greater China) with respect to the Global Phase 3 Study.

5.3 Meetings with Regulatory Authorities. Advaccine shall lead all interactions with Regulatory Authorities in the Advaccine Territory with respect to the Products for use in the Field. Advaccine shall keep Inovio reasonably informed of any material regulatory developments related to the Products in the Field in the Advaccine Territory. At each regularly scheduled JSC meeting, Advaccine shall provide Inovio with a list and schedule of any in-person meeting or teleconference with the applicable Regulatory Authorities (or related advisory committees) in the Advaccine Territory planned for the next Calendar Quarter that relates to any Product in the Field. In addition, Advaccine shall notify Inovio as soon as reasonably possible (but in no event later than two (2) Business Days if possible) after Advaccine becomes aware of any additional such meetings or teleconferences that become scheduled for such Calendar Quarter. Inovio shall provide all assistance and documentation reasonably requested by Advaccine to prepare for any such meeting or teleconference, including making available competent personnel to attend any such meeting or teleconference at Advaccine’s reasonable request (subject to reimbursement by Advaccine of Inovio’s costs and expenses with respect thereto). To the extent permitted by applicable Laws and by the Regulatory Authorities (as reasonably determined by Advaccine), Inovio shall have the right to participate (whether directly or through a representative) in all such meetings and teleconferences, at Inovio’s cost. Notwithstanding the foregoing to the contrary, Inovio shall have the right to lead all interactions with Regulatory Authorities in the Advaccine Territory (other than in Greater China) with respect to the Global Phase 3 Study, and Inovio shall keep Advaccine reasonably informed of such regulatory activities in a manner similar to Advaccine’s obligations to Inovio under this Section 5.3 mutatis mutandis.

5.4 Regulatory Costs. Unless otherwise provided in this Agreement, Advaccine shall be responsible for the costs and expenses incurred in connection with the preparation and filing of any and all Regulatory Materials and the maintenance of any and all Regulatory Approvals (including MAA approvals) for the Products in the Field in the Advaccine Territory.

5.5 Right of Reference to Regulatory Materials. Each Party hereby grants to the other Party the right of reference to all Regulatory Materials pertaining to the Products submitted by or on behalf of such Party, subject to provisions in Section 4.9. The receiving Party may use such right of

reference solely for the purpose of seeking, obtaining and maintaining Regulatory Approval of the Products in its respective territory. Each Party shall support the other Party, as reasonably requested by such other Party and at such other Party’s expense, in obtaining Regulatory Approvals in such other Party’s territory, including providing necessary documents or other materials required by applicable Laws to obtain Regulatory Approval in such territory, all in accordance with the terms and conditions of this Agreement.

5.6 No Harmful Actions. If either Party believes that the other Party is taking or intends to take any action with respect to any Product that could reasonably be expected to have an Adverse Risk, whether in the Inovio Territory or in the Advaccine Territory, such Party may bring the matter to the attention of the JSC and the Parties shall discuss in good faith to promptly resolve such concern. Without limiting the foregoing, unless the Parties otherwise agree: (a) (i) Advaccine shall not communicate with any Regulatory Authority having jurisdiction outside the Advaccine Territory, unless so ordered by such Regulatory Authority, in which case Advaccine shall immediately notify Inovio of such order; and (ii) Advaccine shall not submit any Regulatory Materials or seek Regulatory Approvals for the Vaccine or the Product in the Inovio Territory; and (b) (i) except to the extent in connection with the exercise of its retained rights under Section 2.1(b), Inovio shall not communicate with any Regulatory Authority having jurisdiction outside the Inovio Territory, unless in connection with the Global Phase 3 Study or so ordered by such Regulatory Authority, in which case Inovio shall immediately notify Advaccine of such order; (ii) except to the extent in connection with the Global Phase 3 Study or with the exercise of its retained rights under Section 2.1(b), Inovio shall not submit any Regulatory Materials or seek Regulatory Approvals for the Vaccine or the Product in the Advaccine Territory.

5.7 Notification of Threatened Action. Each Party shall immediately notify the other Party (including by providing notice to the other Party’s Alliance Manager) of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including without limitation a Regulatory Authority, which may affect the Development, Manufacture, Commercialization or regulatory status of any Product. Upon receipt of such information, the Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

5.8 Adverse Event Reporting and Safety Data Exchange. Before the Initiation of a Clinical Trial with respect to the Development of any Product in the Advaccine Territory by or on behalf of Advaccine, the Parties shall enter into or amend the then current pharmacovigilance agreement to define and finalize the actions that the Parties shall employ with respect to such Product to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”) for the Development of the Product globally. Further, unless otherwise agreed by the JSC, no later than sixty (60) days before the anticipated launch date of any Product in the Advaccine Territory, the Parties shall enter into a separate Pharmacovigilance Agreement for the Commercialization of the Product. Each of the Pharmacovigilance Agreements shall include mutually acceptable guidelines and procedures for the receipt, investigation, recording, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of the Product, and other routine pharmacovigilance reporting requirements. Such guidelines and procedures shall be in accordance with, and enable the Parties to

fulfill, local and national regulatory reporting obligations under applicable Laws. Furthermore, such agreed procedure shall be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory reporting safety reporting requirement, in which case local reporting requirement shall prevail. The Pharmacovigilance Agreement shall provide for an adverse event database for the Products in the Field in the Advaccine Territory to be maintained by Advaccine at Advaccine’s expense, and a global safety database for the Products to be maintained by Inovio at Inovio’s expense. As between the Parties, Advaccine shall be responsible for preparing all adverse event reports and responses to safety issues and requests of Regulatory Authorities relating to the Products in the Field in the Advaccine Territory, and Advaccine shall be responsible for filing such reports and responses with Regulatory Authorities in the Advaccine Territory. As between the Parties, Advaccine shall also be responsible for reporting any quality complaints, adverse events and safety data related to the Products in the Field in the Advaccine Territory to Inovio for inclusion in the global safety database. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted Sublicensees to comply with such obligations. Notwithstanding the foregoing to the contrary, Inovio shall be responsible for the pharmacovigilance activities in the Advaccine Territory (other than Greater China) in connection with the Global Phase 3 Study, provided however that, a copy of any pharmacovigilance-related filings or reporting for the Global Phase 3 Study shall be provided to Advaccine for review and comment pursuant to the Pharmacovigilance Agreement.

5.9 Remedial Actions. Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Product may be subject to any recall, corrective action or other regulatory action taken by virtue of applicable Laws (a “Remedial Action”). The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action. Advaccine shall, and shall ensure that its Affiliates and Sublicensees will, maintain adequate records to permit the Parties to trace the packaging, labeling, distribution, sale and use (to the extent possible) of the Product in the Advaccine Territory. Advaccine shall have sole discretion with respect to any matters relating to any Remedial Action in the Advaccine Territory, including the decision to commence such Remedial Action and the control over such Remedial Action in its territory, at its cost and expense. Notwithstanding the foregoing to the contrary, any Remedial Action in connection with the Global Phase 3 Study in the Advaccine Territory (other than Greater China) shall be jointly decided by the Parties.

ARTICLE 6
COMMERCIALIZATION

6.1 Overview; Diligence. Subject to the terms and conditions of this Agreement (including the diligence obligations set forth below), Advaccine shall have the sole right and responsibility for and have operational control over all aspects of the Commercialization of the Products in the Field in the Advaccine Territory, including: (a) developing and executing a commercial launch and pre-launch plan, (b) negotiating with applicable Governmental Authorities regarding the price and reimbursement status of the Products; (c) marketing, advertising and promotion; (d) booking sales and distribution and performance of related services; (e) handling all aspects of order processing, invoicing and collection, inventory and receivables; (f) providing customer support, including handling medical queries, and performing other related functions; and (g) conforming its practices and procedures to

applicable Laws relating to the marketing, detailing and promotion of the Products in the Field in the Advaccine Territory. Advaccine shall bear all of the costs and expenses incurred in connection with such Commercialization activities. Advaccine shall use Commercially Reasonable Efforts to Commercialize the Products in the Advaccine Territory and to actively market and sell the Products in the Advaccine Territory and to expand annual Net Sales of the Products in the Advaccine Territory. Without limiting the generality of the foregoing, Advaccine shall use Commercially Reasonable Efforts to conduct its Commercialization activities under and in accordance with the Commercialization Plan.

6.2 Commercialization Plan.

(a)General. Advaccine shall Commercialize the Products in the Field in the Advaccine Territory pursuant to a commercialization plan (the “Commercialization Plan”). The Commercialization Plan shall include (i) a detailed description of all key strategic decisions (including messaging, branding, marketing, advertising, sales force positioning, number of representatives and details, pricing strategy, etc.), implementation tactics and pre-launch and post-launch activities; (ii) a reasonably detailed description and timeline of Advaccine’s, its Affiliates’ and their respective Sublicensees’ Commercialization activities for the Products in the Advaccine Territory for the next Fiscal Year, including medical marketing activities, sales forecasts and projections, pricing, reimbursement, market research, sales training, distribution channels, customer service and sales force matters related to the launch and sale of the Products in the Advaccine Territory, and (iii) a strategic plan for Commercialization of the Products in the Advaccine Territory for the following two (2) Fiscal Years. In the event that Advaccine’s Commercialization Plan requires the use of Inovio internal resources to conduct additional activities, the extent of such need shall be clearly specified in the Commercialization Plan and will require the prior written approval of Inovio.

(b)Initial Plan and Amendments. Within a reasonable time (but no less than six (6) months) prior to the anticipated Regulatory Approval of each Product in the Advaccine Territory, Advaccine shall prepare and present to the JSC an initial Commercialization Plan for review and discussion (but not approval) by the JSC. From time to time (but at least on an annual basis) during the Term, Advaccine shall prepare updates and amendments, as appropriate, to the then-current Commercialization Plan (including to take into account changed circumstances that are material to the Commercialization of Product, including changes in the marketplace, relative success of the Product, and other relevant factors influencing such plan and activities), and shall submit all updates and amendments to the Commercialization Plan to the JSC for review and discussion (but not approval). Notwithstanding anything to the contrary contained in this Agreement, the Commercialization Plan, and any updates and amendments thereto, shall not require the approval of the JSC or Inovio.

6.3 Data Exchange. Advaccine shall keep Inovio reasonably informed of Advaccine’s, its Affiliates’ and their respective Sublicensees’ Commercialization activities with respect to the Products in the Field in the Advaccine Territory. Inovio shall provide to Advaccine, upon Advaccine’s request, and no more than once every six (6) months, at Inovio’s cost, copies of any materials prepared by or on behalf of Inovio that are necessary or reasonably useful in connection with Advaccine’s Commercialization of the Products in the Field in the Advaccine Territory (including

relevant training materials, global brand and global market research, in each case, with respect to the Products), and, to the extent elected by Advaccine, Advaccine shall have the right to use such materials in connection with the Commercialization of the Products in the Field in the Advaccine Territory in accordance with the Agreement.

6.4 No Diversion. Each Party hereby covenants and agrees that it shall not, and shall ensure that its Affiliates and Sublicensees (in the case of Advaccine) or licensees, including Inovio Partners (in the case of Inovio) will not, directly or indirectly, promote, market, distribute, import, sell or have sold the Products, including via internet or mail order, in the other Party’s territory. With respect to any country in the other Party’s territory, a Party shall not, and shall ensure that its Affiliates and their respective Sublicensees (in the case of Advaccine) or licensees, including Inovio Partners (in the case of Inovio) will not: (a) establish or maintain any branch, warehouse or distribution facility for the Products in such countries, (b) knowingly engage in any advertising or promotional activities relating to the Products that are directed primarily to customers or other purchaser or users of the Products located in such countries, (c) actively solicit orders for the Products from any prospective purchaser located in such countries, or (d) knowingly sell or distribute the Products to any person in such Party’s territory who intends to sell or has in the past sold the Products in such countries. If either Party receives any order for any Product from a prospective purchaser reasonably believed to be located in a country in the other Party’s territory, such Party shall immediately refer that order to the other Party and such Party shall not accept any such orders. Each Party shall not deliver or tender (or cause to be delivered or tendered) the Products into a country in the other Party’s territory. Each Party shall not, and shall ensure that its Affiliates and their respective Sublicensees (in the case of Advaccine) or licensees, including Inovio Partners (in the case of Inovio) will not, knowingly restrict or impede in any manner the other Party’s exercise of its retained exclusive rights in the other Party’s territory. For the avoidance of doubt, nothing in this Section 6.4 shall limit Inovio’s retained rights under Section 2.1(b).

6.5 Field Restrictions. Advaccine hereby covenants that it shall not, and shall cause its Affiliates and Sublicensees not to, promote or encourage the use of the Products in the Advaccine Territory for any use outside the Field.

6.6 Global Purchasing Agents. In the event that a global purchasing entity such as [***] (each, a “Global Purchasing Entity”) desires to enter into a purchase agreement for the Product in both the Inovio Territory and the Advaccine Territory (outside Greater China), the Parties shall enter into good faith negotiations for an arrangement to supply Product in the Advaccine Territory (excluding Greater China) to such organizations for such commercialization in the Advaccine Territory(outside Greater China). Each Party shall provide reasonable notice to the other Party in advance of submission of any proposal to a Global Purchasing Entity to allow the non-submitting Party to review the proposal. In the event that Inovio enters into any such agreement with such Global Purchasing Entity, Advaccine will use Commercially Reasonable Efforts to provide the Product for use in the Advaccine Territory (outside Greater China) at a reasonable and affordable price which shall be designed to maximize access and shall be negotiated and agreed by the Parties in good faith. In the event Advaccine cannot supply to such sufficient quantities of Product, Inovio (or its designee) will have the right to manufacture and/or supply such quantities of Product to meet the agreed needs of such Global Purchasing Entity in the Advaccine Territory (outside Greater China). Notwithstanding the foregoing, Advaccine shall not

submit a proposal to any Global Purchasing Entity for the Product that includes countries in the Inovio Territory without the prior written approval of Inovio.

ARTICLE 7
MANUFACTURE AND SUPPLY

7.1 Clinical Supply.

(a)Clinical Inovio Device. During the Term, Inovio will supply Advaccine’s clinical requirements of the applicable Inovio Device for clinical use in the Advaccine Territory, at Inovio’s fully burdened manufacturing cost plus an agreed-to profit margin to support preclinical development and clinical studies in the Field in the Advaccine Territory. Upon Advaccine’s reasonable request, the Parties agree to negotiate in good faith the terms and conditions of a supply of Inovio Device manufactured by or on behalf of Inovio under a separate agreement (the “Clinical Supply Agreement”). The Clinical Supply Agreement shall contain commercially reasonable terms as may be agreed upon in good faith by the Parties. Notwithstanding the foregoing, Advaccine shall have the right to Manufacture in the Advaccine Territory any Arrays used with the Inovio Device for use in the Field in the Advaccine Territory.

(b)Vaccine Supply. During the Term, Inovio will supply Advaccine’s clinical requirements of the Vaccine for clinical use in the Advaccine Territory, at Inovio’s fully burdened manufacturing cost plus an agreed-to profit margin to support preclinical development and clinical studies in the Field in the Advaccine Territory. Upon Advaccine’s reasonable request, the Parties agree to negotiate in good faith the terms and conditions of a supply of the Vaccine manufactured by or on behalf of Inovio under a separate agreement.

(c)Vaccine Manufacturing Technology Transfer. Advaccine shall have the right to appoint additional or alternative suppliers (or conduct its own Manufacturing) of the applicable Vaccine for clinical use in the Advaccine Territory. Additionally, Inovio may elect to transfer Manufacturing responsibility for the Vaccine to Advaccine. Upon either Party’s request, the Parties shall enter into a manufacturing technology transfer agreement (“Clinical Manufacturing Technology Transfer Agreement”) as more fully detailed below. Under such Clinical Manufacturing Technology Transfer Agreement, Inovio shall transfer to Advaccine (or its designee) such documents and information, and provide such technical assistance and support, necessary or reasonably useful for Advaccine to Manufacture or have Manufactured the Vaccine or the Products, to the extent Controlled by Inovio as of such date; provided that (i) Advaccine shall notify Inovio of any such Third Party contractor and shall not engage with such Third Party contractor if Inovio believes in good faith that such Third Party contractor is not capable of manufacturing the applicable Vaccine with sufficient quality to satisfy GMP requirements, and (ii) any such Third Party contractor shall (A) be bound by written obligations of confidentiality, non-use and compliance with applicable Laws (including Proper Conduct Practices, GMP and any regulations required by the NMPA, the FDA and the EMA), consistent with this Agreement and have agreed in writing to assign to Advaccine all Data, Information, inventions or other

intellectual property generated by such subcontractor in the course of performing such subcontracted work, and (B) upon reasonable prior written notice given by Inovio to Advaccine, shall permit Inovio or its representatives to audit, during such subcontractor’s normal business hours and without additional charge, the performance of Manufacturing activities hereunder, the facilities used and relevant processes, systems, books, documents and records, in order to determine Advaccine’s compliance with this Agreement. Advaccine shall pay Inovio’s reasonable external costs (including FTEs) incurred in connection with providing such information or assistance pursuant to this Section 7.1(c).

7.2 Commercial Supply.

(a)Commercial Inovio Device. During the Term, Inovio will supply Advaccine’s commercial requirements of the applicable Inovio Device for commercial use in the Field in the Advaccine Territory, at Inovio’s fully burdened manufacturing cost plus an agreed-to profit margin. Upon Advaccine’s reasonable request, the Parties agree to negotiate in good faith the terms and conditions of a supply of Inovio Device manufactured by or on behalf of Inovio under a separate agreement (the “Inovio Device Commercial Supply Agreement”). The Inovio Device Commercial Supply Agreement shall contain commercially reasonable terms as may be agreed upon in good faith by the Parties. Notwithstanding the foregoing, Advaccine shall have the right to Manufacture Arrays used with the Inovio Device for use in the Field in the Advaccine Territory. Notwithstanding the foregoing, in the event that Inovio is unable to supply sufficient quantity of the Inovio Device pursuant to the Inovio Device Commercial Supply Agreement to meet at least eighty-five percent (85%) of Advaccine forecasted requirements of the Products in the Advaccine Territory for a period of six (6) consecutive months, then Inovio shall establish a second source supplier for the Inovio Device in order to Manufacture the Inovio Device for use in the Advaccine Territory for use with the Products.

(b)Manufacture and Supply. Advaccine assumes responsibility for the manufacture and supply of the Vaccine itself or through a contract manufacturer, for commercial use in the Field in the Advaccine Territory. Advaccine assumes responsibility for the manufacture and supply of any Arrays itself or through a contract manufacturer for use in the Field in the Advaccine Territory.

(c)Manufacturing Technology Transfer. In the event that neither Party has already initiated a technology transfer in accordance with Section 7.1(c), then, upon either Party’s request, the Parties shall enter into a manufacturing technology transfer agreement for the applicable Vaccine in the manner set forth in Section 7.1(c). Advaccine shall pay Inovio’s reasonable external costs incurred in connection with providing such information or assistance pursuant to this Section 7.2(c).

7.3 Distribution. Advaccine will be solely responsible for the distribution of the Products in the Field in the Advaccine Territory.

7.4 Brand Security and Anti-Counterfeiting. The Parties will establish contacts for communication regarding brand security issues, and each Party shall reasonably cooperate with the

other Party with respect thereto. Practices around these incidents will comply with Inovio’s then-current standards, where such standards define product security features, warehouse/cargo protection requirements, and response and communication process for such incidents.

ARTICLE 8
COMPENSATION

8.1 Upfront Payment; Global Development Cost Sharing.

(a)Upfront Payment; Annual Maintenance Fee. Inovio hereby acknowledges receipt of the upfront payment paid by Advaccine under the Prior Agreement. Beginning in the first Calendar Year after First Commercial Sale of the Product in the Advaccine Territory (outside of Greater China), Advaccine shall pay to Inovio a non-refundable, non-creditable annual maintenance fee of One Million Five Hundred Thousand U.S. Dollars (US$1,500,000), payable on each anniversary of the date of First Commercial Sale of the Product in the Advaccine Territory (outside of Greater China), for the first five anniversaries thereof the Effective Date; provided, that such annual maintenance fee shall be creditable against royalties payable under Section 8.4 with respect to Net Sales in the Advaccine Territory (outside of Greater China) in such Calendar Year. Notwithstanding the foregoing, Advaccine shall not be subject to such annual maintenance fee if Inovio fails to supply sufficient quantity of the Inovio Device in breach of the Inovio Device Commercial Supply Agreement.

(b)Global Development Cost Sharing.

(i)The Parties shall share on an equal basis all Global Development Costs incurred on or after [***]. Promptly following the end of each Calendar Quarter during which Global Development Costs are incurred by or on behalf of Inovio (but in no event later than thirty (30) days following the end of such Calendar Quarter), Inovio will provide to Advaccine an expense report (in a form which shall be agreed by the Parties through the JSC) disclosing such incurred shared Global Development Costs. Within thirty (30) Business Days following receipt of such expense report by Advaccine, Advaccine will make a payment of its fifty percent (50%) share of such Global Development Costs. For clarity, the Parties desire Advaccine to make payments directly to Third Party service providers of the Global Phase 3 Study, however, in the event that such direct payments are not feasible or permitted by such Third Party service provider, Advaccine shall pay its share of the Global Development Costs directly to Inovio. The provisions of Sections 8.6, 8.7, 8.8(a), and 8.9 shall apply to such payments mutatis mutandis. Notwithstanding the foregoing, the total amount of payments by Advaccine for the Global Development Costs and the payments of Milestone Event #2 defined in Section 8.2 shall be capped at US$[***]prior to [***] (“[***] Payment Cap”). Upon [***], Advaccine and Inovio shall agree upon a payment timeline by which Advaccine will pay to Inovio any amounts that would have been payable by Advaccine to Inovio under this Section 8.1(b) and Section 8.2 but for the [***]Payment Cap (such timeline not to exceed [***]).

(ii)In the event that Advaccine reasonably believes, by exercising its audit rights pursuant to Section 4.5(b) in connection with the records and conduct of the Global

Phase 3 Study, that there are significant deviations from the Global Phase 3 Study Plan or significant non-compliance with applicable Laws in the conduct of the Global Phase 3 Study, it shall have the discretion to discontinue its payments for subsequent Global Development Costs and request Inovio to take corrective and preventive actions.

8.2 Development Milestone Payments. Advaccine shall pay to Inovio the one-time, non-refundable, non-creditable payments set forth in the table below. Advaccine shall notify Inovio in writing within ten (10) days of achievement by a Product of a regulatory milestone event (except for milestone No. 3, which Inovio shall notify Advaccine upon achievement) and Advaccine shall pay to Inovio the required milestone payment within thirty (30) Business Days of the achievement by a Product of the applicable milestone event.


No.	Milestone Event	Milestone Payment
1	Enrollment of first subject in first Phase 2 Clinical Trial or Pivotal Clinical Trial for the Product in the Advaccine Territory	[***]
2	Enrollment of first subject in first Phase 3 Clinical Trial or Pivotal Clinical Trial for the Product in the Advaccine Territory	[***]
3	Marketing Authorization for a Product in the Field by the First Regulatory Authority in the Advaccine Territory	[***]
4	Marketing Authorization for a Product in the Field in the U.S. by the FDA	[***]
5	First Commercial Sale of a Product in the Advaccine Territory	[***]

Notwithstanding the foregoing, Inovio acknowledges receipt of Milestone Payment #1 from Advaccine pursuant to the terms of the Prior Agreement and no further payment is required under this Agreement for Milestone Event #1. Additionally, notwithstanding the earlier achievement of Milestone Event #2, Milestone Payment #2 may be deferred by Advaccine [***] and shall be subject to the [***]Payment Cap. If any development milestone event set forth above is achieved before any prior development milestone event, then such prior development milestone event(s) shall then also be due and payable together with the achieved development milestone event. For the avoidance of doubt, two or more development milestones may be achieved concurrently.

8.3 Commercial Milestone Payments.

(a)Advaccine shall pay to Inovio the additional one-time, non-refundable, non-creditable payments set forth in the table below within forty-five (45) Business Days after the Calendar Quarter in which the aggregate Net Sales of the Products sold in the Advaccine Territory in a Calendar Year of the corresponding threshold value indicated below is first achieved. For clarity, each of the following milestone payments shall be payable only once regardless of the number of times such milestone is achieved.


Commercial Milestone Event			Milestone Payment
The aggregate Net Sales of the Products in the Advaccine Territory in a given Calendar Year first reaches [***]			[***]
The aggregate Net Sales of the Products in the Advaccine Territory in a given Calendar Year first reaches [***]			[***]
The aggregate Net Sales of the Products in the Advaccine Territory in a given Calendar Year first reaches [***]			[***]
The aggregate Net Sales of the Products in the Advaccine Territory in a given Calendar Year first reaches [***]			[***]
The aggregate Net Sales of the Products in the Advaccine Territory in a given Calendar Year first reaches [***]			[***]

8.4 Royalties on Net Sales.

(a)Royalty Rates. Subject to the terms and conditions of this Section 8.4, Advaccine shall pay to Inovio non-creditable, non-refundable royalties equal to [***] Net Sales of all Products in the Advaccine Territory on a Product-by- Product and Region-by-Region basis during the applicable Royalty Term.

(b)Royalty Term. Royalties payable under Section 8.4(a) shall be paid by Advaccine (on a Product-by-Product and Region-by-Region basis) from the period beginning on the date of the First Commercial Sale of each Product in a Region in the Advaccine Territory and continuing until the later of: (i) ten (10) years from the date of First Commercial Sale of such Product in such Region, and (ii) expiration of the last Valid Claim of an Inovio Licensed Patent Covering such Product in such Region (the “Royalty Term”). For clarity, if a Valid Claim of an Inovio Licensed Patent Covers the Manufacture of such Product in such Region, then regardless of whether such Product is actually Manufactured in such Region, such Product shall be deemed to be Covered by a Valid Claim of an Inovio Licensed Patent in such Region.

(c)Royalty Reduction.

(i)Biosimilar Entry. If a Product is generating Net Sales in a Region during the applicable Royalty Term at a time when a Biosimilar Product with respect to such Product is being sold in such Region, and such Biosimilar Product(s) obtain (x) a market share of at least [***] in such Region on a volume basis, then, subject to Section 8.4(c)(iv), the royalty rates applicable to Net Sales of such Product in such Region shall be reduced to [***] of the royalty rate set forth in Section 8.4(a), or (y) a market share of at least [***]in such Region on a volume basis, then, subject to Section 8.4(c)(iv), the royalty rates applicable to Net Sales of such Product in such Region shall be reduced to [***] of the royalty rate set forth in Section 8.4(a), but in each case of (x) and (y) only for so long as the Biosimilar Product with respect to such Product is being sold in such Region with such market share.

(ii)Third Party Royalty Credit. If Advaccine determines (based on advice of outside Patent counsel) that it is necessary to obtain a license to any Patent owned by a Third Party that contains claims that cover the Vaccine in a Region in the Advaccine Territory (i.e., but for such license, the making, having made, using, selling, offering for sale, or importing of the Vaccine, as contained in or comprising a Product, would infringe such Patent owned by such Third Party in such Region) and Advaccine obtains such a license, then, subject to Section 8.4(c)(iv), Advaccine shall have the right to deduct, from the royalty payment that would otherwise be payable to Inovio pursuant to Section 8.4(a) with respect to Net Sales of such Product in such Region in a particular Calendar Quarter, an amount equal to [***] of the payments by Advaccine to such Third Party pursuant to such license on account of the sale of such Product in such Region during such Calendar Quarter; provided that (i) in no event will the royalty payment that would otherwise be payable to Inovio pursuant to this Section 8.4 with respect to Net Sales of such Product in such Region in such particular Calendar Quarter (without regard to any other reductions) be reduced by more than [***] in any given Calendar Quarter as a result of any deduction under this Section 8.4(c)(ii) and (ii) Advaccine will be entitled to carry forward to subsequent Calendar Quarters any amounts with respect to which Advaccine would have been entitled to take a deduction pursuant to this Section 8.4(c)(ii) but is unable to take such deduction pursuant to the foregoing sub-clause (i).

(iii)No Valid Claim. For each Product and for any period during the Royalty Term in which the sale of such Product in a given country is neither: (i) Covered by any Valid Claim of an Inovio Licensed Patent or Joint Patent nor (ii) protected by any data exclusivity right applicable to such Product in such country, then the Royalty rate applicable to Net Sales of such Product in such country during such period shall be equal to [***] of the applicable Royalty rate set forth in this Section 8.4.

(iv)Notwithstanding the foregoing, in no event shall the operation of Section 8.4(c)(i), Section 8.4(c)(ii) or Section 8.4(c)(iii)), individually or in combination, reduce the royalties paid to Inovio with respect to the Net Sales of any Product in any Region in the Advaccine Territory in any Calendar Quarter to less than [***] of the amount that would otherwise have been payable to Inovio pursuant to Section 8.4(a) with respect to such Net Sales.

8.5 Royalty Payments; Reports. Royalties under Section 8.4 shall be calculated and reported for each Calendar Quarter during the Royalty Term and shall be paid within thirty (30) Business Day after the end of the applicable Calendar Quarter, commencing with the Calendar Quarter in which the First Commercial Sale of a Product occurs. Each payment of royalties shall be accompanied by a report of Net Sales of the Products by Advaccine, its Affiliates and their respective Sublicensees in sufficient detail to permit confirmation of the accuracy of the royalty payment made, including: (a) the amount of gross sales and Net Sales of the Products in the Advaccine Territory on a Product-by-Product and Region-by-Region basis, (b) an itemized calculation showing the deductions from gross sales (by major category as set forth in the definition of Net Sales) to determine Net Sales, and (c) a calculation of the amount of royalties due to Inovio in U.S. Dollars, including the application of any exchange rate used.

8.6 Payment Method; Foreign Exchange; Blocked Payments. All payments owed by Advaccine under this Agreement shall be made by wire transfer in immediately available funds to a bank and account designated in writing by Inovio. For clarity, all payments by Advaccine to Inovio pursuant to Sections 8.1, 8.2, 8.3 and 8.4 shall be in U.S. Dollars. The rate of exchange to be used in computing the amount of currency equivalent in U.S. Dollars of any amounts payable in U.S. Dollars by Advaccine to Inovio under this Agreement shall be determined and calculated (i) with respect to the Chinese Yuan, using the middle rate published by the Bank of China for exchange of US dollars with the Chinese Yuan on the date of transfer of the payment, and (ii) with respect to any other currency, the average rate of exchange based on OANDA rates for the Calendar Quarter in which the applicable payment is due. In the event that, by reason of applicable Laws in the Advaccine Territory, it becomes impossible or illegal for Advaccine or its Affiliate to transfer, or have transferred on its behalf, payments to Inovio, Advaccine shall promptly notify Inovio of the conditions preventing such transfer and such payments shall be deposited in local currency in the relevant country to the credit of Inovio in a recognized banking institution designated by Inovio.

8.7 Interest on Late Payments. If Inovio does not receive payment of any sum due to it on or before the due date, interest shall thereafter accrue on the sum due to Inovio until the date of payment at the per annum rate of [***] over the then-current prime rate reported in The Wall Street Journal or the maximum rate allowable by applicable Laws, whichever is lower, with such interest compounded quarterly.

8.8 Records; Audits.

(a)Advaccine shall, and shall cause its Affiliates and their respective Sublicensees to, maintain in accordance with Accounting Standards, reasonably complete and accurate records in sufficient detail to permit Inovio to confirm the accuracy of the calculation of royalty payments and the achievement of the milestone events. All payments and other relevant amounts under this Agreement shall be accounted for in accordance with Accounting Standards. Upon reasonable prior written notice, in any event no less than thirty (30) days prior written notice, such records shall be available for examination during regular business hours and in a manner that does not interfere with Advaccine’s business activities for a period of three (3) years from the end of the Fiscal Year to which they pertain, and not more often than once each Fiscal Year, by an independent certified public accountant selected by Inovio and reasonably acceptable to Advaccine, for the sole purpose of verifying the accuracy of the financial reports furnished by Advaccine pursuant to this Agreement and any payments with respect thereto. Any such auditor shall not disclose Advaccine’s Confidential Information, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by Advaccine or the amount of payments due under this Agreement. Any amounts shown to be owed but unpaid shall be paid within thirty (30) days from the accountant’s report, plus interest (as set forth in Section 8.7) from the original due date. Inovio shall bear the full cost of such audit unless such audit discloses an underpayment by Advaccine of more than [***] of the amount due for the audited period, in which case Advaccine shall bear the full cost of such audit

(b)Inovio shall, and shall ensure that its Affiliates and its and their respective employees, agents and contractors, maintain complete and accurate records with respect to

Inovio’s pharmacovigilance-related obligations set forth in Section 5.8. Upon reasonable prior written notice, such records shall be available for examination during regular business hours for a period of three (3) years from the end of the Fiscal Year to which they pertain, and not more often than once each Fiscal Year by Advaccine or its designee that is reasonably acceptable to Inovio, for the sole purpose of ensuring compliance with NMPA and other Regulatory Authority regulations. Any such records shall be deemed Confidential Information of Inovio.

8.9 Taxes.

(a)Taxes on Income. Except as set forth in this Section 8.9, each Party shall be solely responsible for the payment of all taxes imposed on its share of income arising directly or indirectly from the efforts of the Parties under this Agreement.

(b)Withholding Taxes. Subject to Section 8.9(d), if Advaccine is required by applicable Laws to make any tax deduction, tax withholding or similar payment (other than value-added tax, any goods and services tax, harmonized sales tax and any similar provincial sales tax) from any amount paid or payable by Advaccine to Inovio (a “Tax Withholding”) under this Agreement, then in the case of any payments to be made by Advaccine to Inovio under this Agreement (including pursuant to Sections 8.1, 8.2, 8.3, and 8.4), Advaccine will (A) deduct and withhold the amount of such Tax Withholding for the account of Inovio to the extent required by applicable Laws (such amounts payable to Inovio shall be reduced by the amount of Tax Withholding deducted and withheld) and (B) pay any such Tax Withholding (including any additional Tax Withholding required with respect to Advaccine’s additional payments under this Section 8.9) directly to the proper Governmental Authority.

(c)VAT. All payments due to Inovio from Advaccine pursuant to this Agreement shall be paid exclusive of, and without reduction for, any value-added tax (including, for greater certainty, any goods and services tax, harmonized sales tax and any similar taxes) (“VAT”) (which, if applicable, shall be payable by Advaccine). Advaccine shall be responsible for the payment of all VAT applicable to the payments made by Advaccine to Inovio under this Agreement in the Advaccine Territory and shall file all applicable VAT tax returns or seek any exemption or reduction of such VAT pursuant to any applicable Laws. Inovio shall cooperate, to the extent reasonably required, with the filing of any such VAT tax returns or any application of reduction or exemption of such VAT with the proper Government Authority in the Advaccine Territory. Advaccine shall indemnify Inovio for any VAT imposed on Inovio in the Advaccine Territory with respect to the payments made to it by Advaccine under this Agreement and if Inovio directly pays any such VAT, Advaccine shall promptly reimburse Inovio for such VAT including all reasonable related costs. If Inovio determines that it is required to report any such tax, Advaccine shall promptly provide Inovio with applicable receipts and other documentation necessary or appropriate for such report. For clarity, this Section 8.9(c) is not intended to limit Advaccine’s right to deduct VAT in determining Net Sales.

(d)Tax Cooperation. Without limiting Section 8.9(b) and 8.9(c), the Parties agree to cooperate with one another and use reasonable efforts to reduce or eliminate Tax Withholding or similar obligations in respect of payments made by Advaccine to Inovio under

this Agreement (including pursuant to Sections 8.1, 8.2, 8.3 and 8.4). To the extent Advaccine is required to make any Tax Withholdings for any payment to Inovio, Advaccine shall pay the amounts of such taxes to the proper Governmental Authority in a timely manner and promptly transmit to Inovio an official tax certificate or other evidence of such withholding sufficient to enable Inovio to claim such payment of taxes from any applicable Government Authority. Inovio shall provide Advaccine any tax forms or other similar documentation that may be reasonably necessary in order for Advaccine not to make any Tax Withholdings or to make Tax Withholdings at a reduced rate under an applicable bilateral income tax treaty, and shall update such forms and documentation from time to time as necessary to reflect changes in facts. Each Party shall provide the other with reasonable assistance to enable the recovery, as permitted by applicable Laws, of Tax Withholdings, VAT or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party bearing such withholding tax or VAT. Specifically, in the event that any tax has been withheld upon a payment made under this Agreement or has otherwise been remitted to a Governmental Authority, if requested by either Party, and if, and for so long as, the Parties acting in good faith mutually agree that there is a reasonable prospect of successfully obtaining a refund of such tax, then the other Party shall, at the requesting Party’s sole cost and expense, seek a refund of such tax from the proper Governmental Authority. In the event that any taxes withheld or reimbursed by Advaccine under Section 8.9(a) are subsequently refunded to Advaccine by the appropriate Governmental Authority, Advaccine shall pay over the amount of such refund, less any cash Taxes attributable to the receipt thereof and any reasonable expenses incurred by Advaccine in obtaining such refund. Advaccine agrees to reasonably cooperate with Inovio and its Affiliates in the pursuit of such tax refund (including, if required by applicable Laws or by the applicable Governmental Authority, permitting Inovio to seek such tax refund in Advaccine’s name and participating in any application or appeal that requires that Advaccine be the party applying for such tax refund, solely with Advaccine’s prior written consent); provided that, Inovio agrees to assume responsibility for direct payment of lawyers’ and other advisors’ fees and any other costs associated with seeking such refund. Notwithstanding anything contained in the Agreement to the contrary, in the event that Inovio is unable to utilize any portion of a Tax Withholding as tax credit to effectively lower its income tax for the applicable tax year during which the applicable payment is received, Advaccine shall reimburse Inovio for any such portion thereof within forty-five (45) days after receipt of an invoice from Inovio (and shall gross-up Inovio for any Tax Withholding on such payment).

ARTICLE 9
INTELLECTUAL PROPERTY MATTERS

9.1 Ownership; License Grants.

(a)Data Generated by Inovio. Inovio shall solely own all Data generated by Inovio. For clarity, all Data solely directed to the Vaccine and the Array Controlled by Inovio are included in the Inovio Licensed Know-How and licensed to Advaccine under Section 2.1(a).

(b)Data Generated by Advaccine. Advaccine shall solely own all Data generated by Advaccine in the Development of the Vaccine and the Products in the Field in the

Advaccine Territory. Advaccine hereby grants to Inovio (i) an irrevocable, perpetual, royalty-free, fully paid-up, exclusive license, with the right to grant sublicenses, to use such Data generated and owned by Advaccine for the purpose of seeking and maintaining any Regulatory Approval for the Vaccine or the Product in the Inovio Territory, and (ii) upon expiration or termination of the Agreement (other than termination of the Agreement by Advaccine pursuant to Sections 13.4 or 13.5), an irrevocable, perpetual, royalty-free, fully paid-up, non-exclusive license, with the right to grant sublicenses, to use such Data generated and owned by Advaccine for the Development, Manufacture and Commercialization of the Vaccine or the Product in the Field in the Advaccine Territory.

(c)Product Materials. Subject to the terms and conditions of this Agreement, each Party hereby grants to the other Party a fully-paid up, royalty-free exclusive license, with the right to grant sublicenses under multiple tiers, to use Product Materials generated and owned by such Party, solely to the extent reasonably necessary for the Development, Manufacture (with respect to Advaccine, solely to the extent applicable under Section 7.2) and Commercialization of the Vaccine and the Product in the Field in the other Party’s respective territory during the Term of this Agreement.

(d)Inventions. Inventorship of any Invention will be determined in accordance with the standards of inventorship and conception under U.S. patent laws.

(i)Inovio Inventions. Any Invention generated, developed, conceived or reduced to practice (constructively or actually) solely by or on behalf of Inovio, its Affiliates and their respective licensees (including Inovio Partners), including their employees, agents and contractors (“Inovio Inventions”) shall be solely and exclusively owned by Inovio. For clarity, any and all Inovio Inventions that are Controlled by Inovio and reasonably necessary for the Development, Manufacture and Commercialization of the Vaccine and the Product in the Field in the Advaccine Territory shall be included in the Inovio Technology licensed to Advaccine under Section 2.1(a), including any Patent rights therein.

(ii)Advaccine Inventions. Any Inventions generated, developed, conceived or reduced to practice (constructively or actually) solely by or on behalf of Advaccine, its Affiliates and their respective Sublicensees, including their employees, agents and contractors (“Advaccine Inventions”) shall be solely and exclusively owned by Advaccine. Advaccine shall disclose in writing to Inovio all Advaccine Inventions promptly following the generation, development, conception or reduction to practice thereof. Advaccine hereby grants Inovio (A) an irrevocable, perpetual, royalty-free, fully paid-up, exclusive license, with the right to grant sublicenses, under the Advaccine Inventions in the Inovio Territory, and (B) upon expiration or termination of this Agreement (other than termination of this Agreement by Advaccine pursuant to Sections 13.4 or 13.5) an irrevocable, perpetual, royalty-free, fully paid-up, non-exclusive license, with the right to grant sublicenses, under the Advaccine Inventions in the Advaccine Territory, in each case of (A) and (B), solely for the Development, Manufacture and Commercialization of the Vaccine or the Products in the Field.

(iii)Joint Inventions. Any Invention generated, developed, conceived or reduced to practice (constructively or actually) jointly by or on behalf of Advaccine and Inovio, their Affiliates and respective Sublicensees, including their employees, agents and contractors (“Joint Inventions”) shall be jointly owned by the Parties, and, subject to the licenses set forth in this Agreement, each Party may freely exploit such Joint Inventions without any duty to account to the other Party. Each Party shall disclose in writing to the other Party all Joint Inventions promptly following the generation, development, conception or reduction to practice thereof. Advaccine hereby grants Inovio an irrevocable, perpetual, royalty-free, fully paid-up, exclusive license, with the right to grant sublicenses, under its rights in such Joint Inventions (i) in the Inovio Territory, and (ii) upon termination of the Agreement (other than termination of the Agreement by Advaccine pursuant to Sections 13.4 or 13.5), in the Advaccine Territory, in each case of (i) and (ii), solely for the Development, Manufacture and Commercialization of the Vaccine or the Product in the Field. Inovio hereby grants Advaccine an irrevocable, perpetual, royalty-free, fully paid-up, exclusive license, with the right to grant sublicenses, under its rights in such Joint Inventions in the Advaccine Territory solely for the Development, Manufacture and Commercialization of the Vaccine or the Product in the Field.

(e)Affiliates, Sublicensees and Subcontractors. Each Party shall ensure that each of its Affiliates, Sublicensees and subcontractors under this Agreement has a contractual obligation to disclose to it all Data, Product Materials and Inventions generated, invented, discovered, developed, made or otherwise created by them or their employees, agents or independent contractors, and to provide sufficient rights with respect thereto, so that each Party can comply with its obligations to the other Party under this Section 9.1.

9.2 Patent Prosecution.

(a)Definition. For the purpose of this Article 9, “prosecution” of Patents shall include, without limitation, all communication and other interaction with any patent office or patent authority having jurisdiction over a Patent application throughout the world in connection with any pre-grant proceedings and post-grant proceeding, including opposition proceedings.

(b)Inovio Licensed Patents; Joint Patents. Except as set forth in Section 9.2(d), as between the Parties, Inovio shall have the sole right to prepare, file, prosecute and maintain or abandon the Inovio Licensed Patents on a worldwide basis. Except as set forth in Section 9.2(d), as between the Parties, Inovio shall have the sole right to prepare, file, prosecute and maintain or abandon the Joint Patents on a worldwide basis. Inovio shall provide Advaccine with a copy of the draft prepared for the filing of a Joint Patent, before the filing of such Joint Patent and will consider in good faith comments thereto provided by Advaccine in connection with the filing thereof. Inovio shall, at the request of Advaccine, provide Advaccine with regular updates on the prosecution of the Inovio Product-Specific Licensed Patents and Joint Patents in the Field in the Advaccine Territory. For clarity, Advaccine shall not have any rights pursuant to this Agreement with respect to any Inovio Licensed Patents in the Inovio Territory (including any Step-In Rights relating thereto).

(c)Advaccine Patents. Except as set forth in Section 0(d), as between the Parties, Advaccine shall have the sole right to prepare, file, prosecute and maintain or abandon the Advaccine Patents. Advaccine shall provide Inovio with a copy of the draft prepared for the filing of a Advaccine Patent, before the filing of such Advaccine Patent and will consider in good faith comments thereto provided by Inovio in connection with the filing thereof. Advaccine shall provide Inovio with regular updates on the prosecution of the Advaccine Patents in the Field in the Advaccine Territory.

(d)Step-In Rights. Either Party may cease prosecution and/or maintenance of any Patent that such Party is responsible for prosecuting and maintain pursuant to this Section 0 on a country-by-country basis by providing the other Party written notice reasonably in advance of such due date. If the responsible Party elects to cease prosecution or maintenance of the relevant Patent in a country, the other Party, shall have the right, but not the obligation, at its sole discretion and cost, to continue prosecution or maintenance of such Patent and in such country (“Step-In Rights”), provided that Advaccine may only exercise its Step-In Rights with respect to Joint Patents and Inovio Product-Specific Licensed Patents in the Advaccine Territory. If the other Party elects to continue prosecution or maintenance or elects to file additional applications following the responsible Party’s election to cease prosecution or maintenance pursuant to this Section 0(d), the responsible Party shall transfer the applicable patent files to such other Party or its designee and execute such documents and perform such acts at the responsible Party’s expense as may be reasonably necessary to allow the other Party to initiate or continue such filing, prosecution or maintenance at the other Party’s sole expense.

(e)Cooperation. Each Party shall provide the other Party with all reasonable assistance and cooperation in the patent prosecution efforts set forth in this Section 0, including providing any necessary powers of attorney and executing any other required documents or instruments for such prosecution.

9.3 Patent Term Extensions in the Advaccine Territory. The JSC will discuss and recommend for which, if any, of the Patents within the Inovio Licensed Patents, Advaccine Patents and Joint Patents in the Advaccine Territory the Parties should seek patent term extensions. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC, the representatives of the Parties cannot reach an agreement as which Patents such extensions should be sought for, (a) Inovio, in the case of Inovio Licensed Patents and Joint Patents, and (b) Advaccine, in the case of Advaccine Patents, shall have the final decision-making authority with respect to applying for any such patent term extension in the Advaccine Territory, and will act with reasonable promptness in light of the development stage of the Products to apply for any such patent term extension, where it so elects; provided, however, that if only one such Patent can obtain a patent term extension, the Parties will consult in good faith to determine which such Patent should be the subject of efforts to obtain a patent term extension, and further provided that, if an Inovio Licensed Patent is the only Patent that is eligible for a patent term extension with respect to a Product in the Advaccine Territory, then (i) Advaccine shall have the right, but not the obligation, to request Inovio to apply for such patent term extension at Advaccine’s sole discretion and cost, and (ii) upon Inovio’s receipt of such request, Inovio shall use Commercially Reasonable Efforts to apply for such patent term extension. Each Party will cooperate fully with the other Party in making such filings or actions, for example and

without limitation, making available all required regulatory Data and Information and executing any required authorizations to apply for such patent term extension. All expenses incurred in connection with activities of each Party with respect to the Patent(s) for which such Party seeks patent term extensions pursuant to this Section 9.3 shall be borne by such Party.

9.4 Patent Enforcement.

(a)Notification; Information Sharing. If either Party becomes aware of any existing or threatened infringement of any Inovio Licensed Patent, Advaccine Patent or Joint Patent (“Infringement”), it shall promptly notify the other Party in writing to that effect and the Parties will consult with each other regarding any actions to be taken with respect to such Infringement. Each Party shall share with the other Party all Information available to it regarding such alleged Infringement, pursuant to a mutually agreeable “common interest agreement” executed by the Parties under which the Parties agree to their shared, mutual interest in the outcome of any suit or other action to enforce the Inovio Licensed Patents, Advaccine Patent and Joint Patent against such Infringement.

(b)Enforcement Rights.

(i)Inovio Product-Specific Licensed Patents; Joint Patents.

(1)Inovio shall have the first right, but not the obligation, to bring an appropriate suit or other action against any Person engaged in the Infringement of any Inovio Product-Specific Licensed Patent or Joint Patent in the Advaccine Territory, at Inovio’s cost and expense. If Inovio elects to commence a suit or other action to enforce the applicable Inovio Product-Specific Licensed Patent or Joint Patent against such Infringement in the Advaccine Territory, then Advaccine shall have the right to join such enforcement action upon written notice to Inovio, and the Parties shall share the cost and expense of such enforcement action equally. If Inovio notifies Advaccine in writing that it does not intend to commence a suit or other action to enforce the applicable Inovio Product-Specific Licensed Patent or Joint Patent against such Infringement or to take other action to secure the abatement of such Infringement, or fails to take any such action after a period of forty-five (45) Business Days following either Party’s receipt of the notice of Infringement pursuant to Section 9.4(a), then, to the extent that such Infringement is resulting from a Third Party’s use or sale of a product that competes with a Product in the Field in the Advaccine Territory, Advaccine shall have the right, but not the obligation, to commence such a suit or take such action, at Advaccine’s sole cost and expense; provided that, in the event the Person engaged in the Infringement of any Inovio Product-Specific Licensed Patent or Joint Patent in the Advaccine Territory is also engaged in such Infringement in the Inovio Territory, and Inovio has commenced a suit to secure the abatement of such Infringement in the Inovio Territory, then Inovio shall promptly notify Advaccine thereof and Advaccine shall not have the right to commence such suit or action without the prior written consent of Inovio, not to be unreasonably withheld. In such case, Inovio shall take appropriate actions in order to enable Advaccine to commence a suit or take the actions set forth in the preceding sentence.

(2)Neither Party shall settle any such suit or action under Section 9.4(b)(i)(1) in any manner that would negatively impact the Inovio Product-Specific Licensed Patents or Joint Patents or that would limit or restrict the ability of Advaccine to sell the Products in the Advaccine Territory, without the prior written consent of the other Party. For clarity, Advaccine shall not have the right to commence any such suit or action against any existing or threatened infringement of the Inovio Product-Specific Licensed Patents or Joint Patents outside the Advaccine Territory.

(ii)Advaccine Patents. Advaccine shall have the first right, but not the obligation, to bring an appropriate suit or other action against any Person engaged in the Infringement of any Advaccine Patent, at Advaccine’s cost and expense. If Advaccine elects to commence a suit to enforce the applicable Advaccine Patent against such Infringement, where such Infringement relates to the Commercialization in the Advaccine Territory of unauthorized products containing the Vaccine, then Inovio shall have the right to join such enforcement action upon notice to Advaccine, and in this case the Parties shall share the cost and expense of such enforcement action equally. If Advaccine notifies Inovio that it does not intend to commence a suit to enforce the applicable Advaccine Patent against such Infringement or to take other action to secure the abatement of such Infringement, or fails to take any such action after a period of ninety (90) days, then Inovio shall have the right, but not the obligation, to commence such a suit or take such action, at Inovio’s cost and expense. In such case, Advaccine shall take appropriate actions in order to enable Inovio to commence a suit or take the actions set forth in the preceding sentence.

(c)Collaboration. Each Party shall provide to the Party bringing a claim, suit or action under Section 9.4(b) (the “Enforcing Party”) with reasonable assistance in such enforcement, including joining such action as a party plaintiff if required by applicable Laws to pursue such action. The Enforcing Party shall keep the other Party regularly informed of the status and progress of such enforcement efforts, and shall reasonably consider the other Party’s comments on any such efforts. The non-enforcing Party shall be entitled to separate representation in such matter by counsel of its own choice and at its own expense, but such Party shall at all times cooperate fully with the Enforcing Party.

(d)Expenses and Recoveries. The Enforcing Party shall be solely responsible for any expenses it incurs as a result of such enforcement action, except that the Parties shall share equally the cost and expense of the enforcement action when Inovio is the Enforcing Party and Advaccine elects to join the enforcement action. If the Enforcing Party recovers monetary damages in such claim, suit or action brought under Section 9.4(b), such recovery shall be allocated first to the reimbursement of any documented expenses incurred by the Parties in such enforcement action, and any remaining amounts shall be shared by the Parties as follows:

(i)if (A) Inovio is the Enforcing Party under Section 9.4(b)(i)(1) and Advaccine elects to join the enforcement action and share the cost and expenses related thereto, or (B) Advaccine is the Enforcing Party under Section 9.4(b)(ii) and Inovio elects to join the enforcement action and share the cost and expenses related thereto: [***] of the remaining

amounts shall be retained by Inovio, and [***] of the remaining amounts shall be paid to Advaccine;

(ii)if Inovio is the Enforcing Party (A) under Section 9.4(b)(i)(1) and Advaccine does not elect to join the enforcement action and share the cost and expenses related thereto, or (B) under Section 9.4(b)(ii): [***] of the remaining amounts shall be retained by Inovio, and [***] of the remaining amounts shall be paid to Advaccine;

(iii)if Advaccine is the Enforcing Party (A) under Section 9.4(b)(ii) and Inovio does not elect to join the enforcement action and share the cost and expenses related thereto, or (B) under Section 9.4(b)(i)(1): [***] of the remaining amounts shall be retained by Advaccine, and [***] of the remaining amounts shall be paid to Inovio.

(e)Sections 9.4(c) and 9.4(d) shall survive the termination of this Agreement solely with respect to any pending enforcement action initiated during the Term under this Section 9.4.

9.5 Third Party Infringement Claims. If the Manufacture, use or sale of the Products in the Field in the Advaccine Territory pursuant to this Agreement results in a claim, suit or proceeding alleging patent infringement against Inovio or Advaccine (or their respective Affiliates, licensees or Sublicensees) (collectively, “Infringement Actions”), such Party shall promptly notify the other Party hereto in writing. Subject to Article 11, the Party for which the Infringement Action is brought against (the “Accused Party”) shall have the right to direct and control the defense of such Infringement Action, at its own expense with counsel of its choice; provided, however, that the other Party may participate in the defense and/or settlement thereof, at its own expense with counsel of its choice. In any event, the Accused Party agrees to keep the other Party reasonably informed of all material developments in connection with any such Infringement Action for which the Accused Party exercises its right to direct and control the defense. The Accused Party agrees not to settle such Infringement Action, or make any admissions or assert any position in such Infringement Action, in a manner that would adversely affect the rights or interests of the other Party, without the prior written consent of the other Party, which shall not be unreasonably withheld or delayed. Subject to Article 11, if the Accused Party does not exercise its right to direct and control the defense of an Infringement Action that is brought against the other Party, then the other Party shall have such right and it shall agree to keep the Accused Party reasonably informed of all material developments in connection with such Infringement Action and it shall not settle such Infringement Action, or make any admissions or assert any position in such Infringement Action, in a manner that would materially adversely affect the rights or interests of the Accused Party, without the prior written consent of the Accused Party, which shall not be unreasonably withheld or delayed.

9.6 Trademarks.

(a)Subject to Section 9.6(c) below, Advaccine shall Commercialize the Products in the Field in the Advaccine Territory under any trademark owned or Controlled by Advaccine (the “Advaccine Product Mark”); provided that, prior to finalizing any Advaccine Product Mark, Advaccine shall provide Inovio with such proposed trademark and related trade

dress and shall reasonably consider in good faith Inovio’s comments with respect thereto. Advaccine shall, and shall cause its Affiliates and Sublicensees to, use the Advaccine Product Mark solely in connection with the Development, Manufacturing, and Commercialization of the Products in the Field in the Advaccine Territory. Advaccine shall own all rights in the Advaccine Product Mark, and all goodwill in the Advaccine Product Mark shall accrue to Advaccine. Advaccine shall register and maintain, at Advaccine’s cost and expense, the Advaccine Product Marks in the Advaccine Territory.

(b)Subject to Section 9.6(c) below, Advaccine shall have the right to brand the Products in the Field in the Advaccine Territory with those trademarks of Advaccine that are associated with Advaccine’s name or identity (“Advaccine Housemarks”). Advaccine shall own all rights in the Advaccine Housemarks, and all goodwill in the Advaccine Housemarks shall accrue to Advaccine.

(c)In connection with Advaccine’s use of any Advaccine Product Mark or Advaccine Housemark, subject to Section 9.6(d), Advaccine shall not, and shall cause its Affiliates and their respective Sublicensees to not make any use of trademarks that are confusingly similar to any trademarks or housemarks of Inovio or its Affiliates (including the corporate name of Inovio or any of its Affiliates), without the prior written consent of Inovio.

(d)Notwithstanding anything to the contrary, to the extent required by applicable Laws, (i) Advaccine may include Inovio’s name and corporate logo on the Product label, packaging, promotional/marketing materials to indicate that the Product is in-licensed from Inovio, and shall display Inovio’s name and corporate logo with equal prominence and comparable size, resolution, print quality, and location, as instructed by Inovio from time to time, as Advaccine’s name and corporate logo is displayed, and (ii) Inovio hereby grants to Advaccine a non-exclusive, fully paid-up, royalty free, sublicensable license to use Inovio’s name and corporate logo solely for the Commercialization of the Product in the Field in the Advaccine Territory, to the extent consistent with the foregoing.

ARTICLE 10
REPRESENTATIONS AND WARRANTIES; COVENANTS

10.1 Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party, as follows:

(a)Corporate Existence. As of the Effective Date, it is a company or corporation duly organized, validly existing, and in good standing under the Laws of the jurisdiction in which it is incorporated;

(b)Corporate Power, Authority and Binding Agreement. As of the Effective Date, (i) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (iii) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such

Party that is enforceable against it in accordance with its terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium and similar Laws affecting creditors’ rights and remedies generally;

(c)No Conflict. The execution and delivery of this Agreement, the performance of such Party’s obligations in the conduct of the Development Plan and the license to be granted pursuant to this Agreement (i) do not and will not conflict with or violate any requirement of applicable Laws existing as of the Effective Date; (ii) do not and will not conflict with or violate the certificate of incorporation or by-laws (or other constating documents) of such Party; and (iii) do not and will not conflict with, violate, breach or constitute a material default under any contractual obligations of such Party or any of its Affiliates existing as of the Effective Date;

(d)No Violation. Neither such Party nor any of its Affiliates is under any obligation to any Person, contractual or otherwise, that is in violation of the terms of this Agreement or that would impede the fulfillment of such Party’s obligations hereunder;

(e)No Debarment. Neither such Party nor any of its Affiliates is debarred or disqualified under the Act or comparable applicable Laws outside the U.S.; and

(f)No Consents. No authorization, consent, approval of a Third Party, nor to such Party’s knowledge, any license, permit, exemption of or filing or registration with or notification to any court or Governmental Authority is or will be necessary for the (i) valid execution and delivery of this Agreement by such Party; or (ii) the consummation by such Party of the transactions contemplated hereby.

10.2 Additional Representations and Warranties of Inovio. Inovio represents and warrants to Advaccine, as of the Effective Date, as follows:

(a)License. Inovio (i) has the right to grant the license that it grants in Section 2.1(a); and (ii) has not granted, and will not grant during the Term, any right to any Third Party that would conflict with the License that it grants in Section 2.1(a) or rights granted to Advaccine hereunder;

(b)Notice of Infringement or Misappropriation. It has not received any written notice from any Third Party asserting or alleging that (i) any research, development, manufacture, or commercialization of a Product by Inovio prior to the Effective Date infringed or misappropriated the intellectual property rights of such Third Party, or (ii) the Development, Manufacture, or Commercialization of the Vaccine and the Products in the Advaccine Territory would infringe or misappropriate the intellectual property rights of such Third Party; to Inovio’s actual knowledge, except as otherwise disclosed to Advaccine prior to the Effective Date, the Development, Manufacture or Commercialization of the Vaccine and theProducts does not infringe or misappropriate any intellectual property rights of any Third Party;

(c)Non-Infringement of Rights by Third Parties. To Inovio’s actual knowledge, no Third Party is infringing or has infringed the Inovio Product-Specific Licensed Patents as of the Effective Date;

(d)Non-Assertion by Third Parties. To Inovio’s actual knowledge, no Third Party has asserted in writing that the issued patents within the Inovio Licensed Patents set forth in Exhibit A are invalid or unenforceable;

(e)No Proceeding. There is no pending, and to Inovio’s actual knowledge, no threatened, adverse action, suit or proceeding against Inovio involving any Inovio Technology or the safety (including any product liability claim) of a Product;

(f)Prosecution of Inovio Licensed Patents. Except with respect to any Inovio Product-Specific Licensed Patents for which Inovio has ceased prosecution and/or maintenance and granted Advaccine Step-In Rights therewith pursuant to Section 9.2(d), all maintenance fees, annuity payments, and similar payments relating to the Inovio Product-Specific Licensed Patents in the Advaccine Territory have been made, and during the Term will be made, in a timely manner. To Inovio’s actual knowledge, prior to the Effective Date, Inovio has not taken action or failed to undertake an action, in connection with filing, prosecuting and maintaining the Inovio Product-Specific Licensed Patents set forth in Exhibit A in the Advaccine Territory in violation of any applicable Laws;

(g)Compliance with Laws. To Inovio’s actual knowledge, Inovio has complied with all applicable Laws in connection with the prosecution of the Inovio Product-Specific Licensed Patents, including the duty of candor owed to any patent office pursuant to such Laws;

(h)Inovio Licensed Patents. Inovio does not have actual knowledge of any Information which leads it to believe that any issued patents included in the Inovio Licensed Patents set forth in Exhibit A are invalid or unenforceable; and

(i)No Conflicts. Inovio has not entered, and shall not enter, into any agreement with any Third Party that is in conflict with the rights granted to Advaccine under this Agreement, and has not taken and shall not take any action that would in any way prevent it from granting the rights granted to Advaccine under this Agreement, or that would otherwise materially conflict with or adversely affect Advaccine’s rights under this Agreement.

10.3 Additional Representations and Warranties of Advaccine. Advaccine represents and warrants to Inovio that, to Advaccine’s knowledge as of the Effective Date Advaccine does not Control any Patent that is necessary to make, use, import, offer for sale or sell the Products in the Field.

10.4 Compliance with Laws.

(a)Each Party shall, and shall ensure that its Affiliates and their respective Sublicensees will, comply in all respects with Proper Conduct Practices, and all applicable Laws

(including all applicable Laws regarding data privacy) in the Development, Manufacturing, and Commercialization of the Products and performance of its obligations under this Agreement, including the ICH, GCP, GLP and any Regulatory Authority and Governmental Authority health care programs having jurisdiction in such Party’s respective territory, each as may be amended from time to time.

(b)Each Party shall immediately notify the other Party if it has any information or suspicion that there may be a violation of any applicable Laws (including Anti-Corruption Laws) in connection with its performance under this Agreement or the Development or Commercialization of any Product hereunder. In the event that either Party has violated or been suspected of violating any of its obligations, representations, warranties or covenants in Section 10.4(a), such Party will take reasonable actions to remedy such breach and to prevent further such breaches from occurring.

(c)Notwithstanding the foregoing, each Party will have the right, upon reasonable prior written notice and during the other Party’s regular business hours, to audit the other Party’s books and records in the event that a suspected violation of any Anti-Corruption Law needs to be investigated (in such Party’s reasonable, good-faith discretion). Such audit shall be conducted by such Party’s audit team comprised of qualified auditors who have received anticorruption training. For clarity, a credible finding, after a reasonable investigation, of any breach of Section 10.4(a) or 10.4(b) with respect to any Anti-Corruption Law, shall be deemed a material breach of this Agreement and allow the non-breaching Party to terminate this Agreement in accordance with Section 13.4.

10.5 Additional Covenants. In addition to any covenants made by Advaccine elsewhere in this Agreement:

(a)Advaccine hereby covenants to Inovio that neither Advaccine nor any of its Affiliates or Sublicensees, will employ or use the services of any Person who is debarred or disqualified under the Act, or comparable applicable Laws outside the U.S., in connection with activities relating to any Product; and in the event that Advaccine becomes aware of the debarment or disqualification or threatened debarment or disqualification of any Person providing services to Advaccine or any of its Affiliates with respect to any activities relating to any Product, Advaccine will immediately notify Inovio in writing and Advaccine will cease, or cause its Affiliate to cease (as applicable), employing, contracting with, or retaining any such Person to perform any services relating to any Product; and

(b)Each Party hereby covenants to the other Party that neither such Party nor any of its Affiliates, nor any of their respective employees shall use any confidential information obtained from any Third Party (including any prior employer) to which such Party or any of its Affiliates, or any of their respective employees has a duty to keep in confidence such information, directly or indirectly, whether obtained prior to the Effective Date or during the Term, in connection with activities performed under this Agreement, unless consented to in writing by such Third party, and such Party shall be solely responsible and liable for, and shall

indemnify the other Party pursuant to Article 11 in connection with, any breach of this covenant by such Party, any of its Affiliates, or their respective employees.

10.6 No Other Representations or Warranties. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY OR ITS AFFILIATES, AND ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED. FOR CLARITY AND WITHOUT LIMITING THE FOREGOING, INOVIO MAKES NO REPRESENTATION OR WARRANTY CONCERNING THE PRODUCTS OR INOVIO TECHNOLOGY EXCEPT AS EXPRESSLY SET FORTH IN THIS ARTICLE 10.

ARTICLE 11
INDEMNIFICATION

11.1 Indemnification by Inovio. Inovio shall defend, indemnify, and hold Advaccine and its Affiliates and their respective officers, directors, employees, and agents (the “Advaccine Indemnitees”) harmless from and against any and all losses, damages, liabilities, actually incurred expenses and costs, including reasonable legal expense and attorneys’ fees (“Losses”) to which any Advaccine Indemnitee may become subject as a result of any claim, demand, action or other proceeding by any Third Party (collectively, “Claims”) arising out of, based on, or resulting from (a) the Development, Manufacture, or Commercialization of the Products in the Field in the Advaccine Territory by or on behalf of Inovio or its Affiliates prior to the Prior Effective Date with respect to Greater China and prior to the Effective Date outside of Greater China, (b) the conduct of the Global Phase 3 Study under this Agreement, (c) the Development, Manufacture, or Commercialization of the Products in the Inovio Territory, (d) the breach of any of Inovio’s obligations under this Agreement, including Inovio’s representations, warranties or covenants set forth herein, (e) the conduct of any pharmacovigilance-related activities set forth in Section 5.8 by or on behalf of Inovio (except to the extent that such Claim arises from Advaccine’s provision of false, misleading, inaccurate or incomplete information to Inovio under Section 5.8 or Advaccine’s breach of its obligations under the Pharmacovigilance Agreement) or (f) the willful misconduct or negligent acts of any Inovio Indemnitee. The foregoing indemnity obligation shall not apply to the extent that (i) the Advaccine Indemnitees fail to comply with the indemnification procedures set forth in Section 11.3 and Inovio’s defense of the relevant Claim is materially prejudiced by such failure, or (ii) any Claim arises from, is based on, or results from any activity or occurrence for which Advaccine is obligated to indemnify the Inovio Indemnitees under Section 11.2.

11.2 Indemnification by Advaccine. Advaccine shall defend, indemnify, and hold Inovio and its Affiliates and their respective officers, directors, employees, and agents (the “Inovio Indemnitees”) harmless from and against any and all Losses to which any Inovio Indemnitee may become subject as a result of any Claims arising out of, based on, or resulting from (a) the Development, Manufacture, or Commercialization of the Products by or on behalf of Advaccine or its Affiliates or

Sublicensees on or after the Prior Effective Date with respect to Greater China and on or after the Effective Date outside of Greater China (except to the extent that any such activities are conducted by or on behalf of Inovio or its Affiliates) (including any Infringement Actions), (b) the breach of any of Advaccine’s obligations under this Agreement, including Advaccine’s representations, warranties, or covenants set forth herein, or (c) the willful misconduct or negligent acts of any Advaccine Indemnitee. The foregoing indemnity obligation shall not apply to the extent that (i) the Inovio Indemnitees fail to comply with the indemnification procedures set forth in Section 11.3 and Advaccine’s defense of the relevant Claim is materially prejudiced by such failure, or (ii) any Claim arises from, is based on, or results from any activity or occurrence for which Inovio is obligated to indemnify the Advaccine Indemnitees under Section 11.1.

11.3 Indemnification Procedures. The Party claiming indemnity under this Article 11 (the “Indemnified Party”) shall give written notice to the Party from whom indemnity is being sought (the “Indemnifying Party”) promptly after learning of such Claim and shall offer control of the defense of such Claim to the Indemnifying Party. The Indemnified Party shall provide the Indemnifying Party with reasonable assistance, at the Indemnifying Party’s expense, in connection with the defense of the Claim for which indemnity is being sought. The Indemnified Party may participate in and monitor such defense with counsel of its own choosing at its sole expense; provided, however, the Indemnifying Party shall have the right to assume and conduct the defense of the Claim with counsel of its choice. The Indemnifying Party shall not settle any Claim without the prior written consent of the Indemnified Party, not to be unreasonably withheld, unless the settlement involves only the payment of money. So long as the Indemnifying Party is actively defending the Claim in good faith, the Indemnified Party shall not settle or compromise any such Claim without the prior written consent of the Indemnifying Party. If the Indemnifying Party does not assume and conduct the defense of the Claim as provided above, (a) the Indemnified Party may defend against, consent to the entry of any judgment, or enter into any settlement with respect to such Claim in any manner the Indemnified Party may deem reasonably appropriate (and the Indemnified Party need not consult with, or obtain any consent from, the Indemnifying Party in connection therewith), and (b) the Indemnifying Party shall remain responsible to indemnify the Indemnified Party as provided in this Article 11. Notwithstanding anything contained in this Section 11.3, the provisions of Section 9.5 shall govern the defense of any Infringement Actions. Additionally, in the event that Inovio has elected to defend any such Infringement Action, then Advaccine shall not be obligated to indemnify Inovio for any Claims related to such Infringement Action; rather, the Parties shall share equal responsibility for any Losses resulting therefrom.

11.4 Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 11.4 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 11.1 OR 11.2, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF ITS EXCLUSIVITY OBLIGATIONS IN SECTION 2.5 OR ITS CONFIDENTIALITY OBLIGATIONS IN ARTICLE 12.

11.5 Insurance. Each Party shall procure and maintain insurance, including product liability insurance, adequate to cover its obligations hereunder and consistent with normal business practices of prudent companies similarly situated. It is understood that such insurance shall not be construed to create a limit of either Party’s liability with respect to its indemnification obligations under this Article 11. Each Party shall provide the other Party with written evidence of such insurance upon request. Each Party shall provide the other Party with written notice at least thirty (30) days prior to the cancellation, nonrenewal or material change in such insurance.

ARTICLE 12
CONFIDENTIALITY

12.1 Confidentiality. Each Party agrees that, during the Term and for a period of ten (10) years thereafter, it shall keep confidential and shall not publish or otherwise disclose and shall not use for any purpose other than as provided for in this Agreement (which includes the exercise of any rights or the performance of any obligations hereunder or thereunder) any Confidential Information of the other Party, except to the extent expressly agreed in writing by the Parties. The foregoing confidentiality and non-use obligations shall not apply to any portion of the other Party’s Confidential Information that the receiving Party can demonstrate by competent written proof:

(a)was already known to the receiving Party or its Affiliate, other than under an obligation of confidentiality, at the time of disclosure by the other Party;

(b)was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;

(c)became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party or its Affiliate in breach of this Agreement;

(d)was disclosed to the receiving Party or its Affiliate without any confidentiality obligations by a Third Party who, to the Party’s knowledge, had a legal right to make such disclosure and who did not obtain such information directly or indirectly from the other Party; or

(e)was independently discovered or developed by the receiving Party or its Affiliate without use of or reference to the other Party’s Confidential Information, as evidenced by a contemporaneous writing.

12.2 Authorized Disclosure. Notwithstanding the obligations set forth in Section 12.1, a Party may disclose the other Party’s Confidential Information and the terms of this Agreement to the extent:

(a)such disclosure is reasonably necessary (i) for the filing or prosecuting of Patent rights as contemplated herein; (ii) to comply with the requirements of Regulatory Authorities with respect to obtaining and maintaining Regulatory Approval of the Product; or (iii) for the prosecuting or defending litigation as contemplated herein;

(b)such disclosure is reasonably necessary to its or its Affiliate’s employees, agents, consultants, contractors, licensees or Sublicensees, (including Inovio Partners) on a need-to-know basis for the sole purpose of performing its obligations or exercising its rights hereunder; provided that in each case, the disclosees are bound by written obligations of confidentiality consistent with those contained in this Agreement; or

(c)such disclosure is (i) reasonably necessary to comply with applicable Laws, including regulations or rules promulgated by applicable securities commissions (or other securities regulatory authorities), security exchanges (the “Securities Regulators”, including without limitation to, the Securities and Futures Commission of Hong Kong, The Stock Exchange of Hong Kong Limited, the China Securities Regulatory Commission, the Shanghai Stock Exchange or the U.S. Securities and Exchange Commission), court order, administrative subpoena or order; or (ii) at the request of applicable Securities Regulators, or reasonably anticipated by one Party that such disclosure will be required by applicable Laws or applicable Securities Regulators; and

(d)solely with respect to the terms of this Agreement and excluding disclosure of any other Confidential Information, such disclosure is reasonably necessary to any bona fide potential or actual investor, acquiror, merger partner, or other financial or commercial partner for the sole purpose of evaluating or carrying out an actual or potential investment, acquisition or other business relationship; provided that in connection with such disclosure, such Party shall inform each disclosee of the confidential nature of such Confidential Information and require each disclosee to treat such Confidential Information as confidential.

Notwithstanding the foregoing, in the event a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to Section 12.2(a), 12.2(c) or 12.2(d), such Party shall promptly notify the other Party of such required disclosure, to the extent that it is legally authorized or permitted to so, and shall use reasonable efforts to obtain, or to assist the other Party in obtaining, a protective order preventing or limiting the required disclosure.

12.3 Publicity; Terms of Agreement.

(a)The Parties agree that the existence or terms of this Agreement are the Confidential Information of both Parties, subject to the special authorized disclosure provisions set forth in this Section 12.3.

(b)If either Party desires to make a public disclosure concerning the existence or terms of this Agreement, such Party shall give the proposed text of such disclosure to the other Party reasonably in advance (but in any case no less than three (3) Business Days prior to the disclosure) for its prior review and approval (except as otherwise provided herein), which approval shall not be unreasonably withheld or delayed. A Party commenting on such a proposed disclosure shall provide its comments, if any, within three (3) Business Days after receiving the proposed disclosure for review (or such shorter period of time as necessitated by regulatory requirements). In addition, where required by applicable Laws, including regulations promulgated by applicable security exchanges, either Party shall have the right to make a press

release or other public disclosure regarding the achievement of each milestone under this Agreement as it is achieved, the achievements of Regulatory Approval in the Advaccine Territory as they occur, or the occurrence of other events that affect either Party’s rights or obligations under this Agreement, including the results of any Clinical Trial of the Products, whether in the Advaccine Territory or the Inovio Territory; provided that such Party shall provide the proposed text of such disclosure to the other Party at least one (1) Business Day in advance, and the other Party shall provide its comments thereto within such one (1) Business Day. In relation to the other Party’s review of such an announcement, such other Party may make specific, reasonable comments on such proposed press release within the prescribed time for commentary. Neither Party shall be required to seek the permission of the other Party to repeat any information regarding the terms of this Agreement that has already been publicly disclosed by such Party, or by the other Party, in accordance with this Section 12.3.

(c)The Parties acknowledge that either or both Parties or their Affiliates may be obligated to file under applicable Laws a copy of this Agreement with Governmental Authorities, including, without limitation, the U.S. Securities and Exchange Commission (the “SEC”). Each Party and its Affiliates shall be entitled to make such a required filing, provided that it requests confidential treatment of the commercial terms and sensitive technical terms hereof to the extent such confidential treatment is reasonably available. In the event of any such filing, each Party will provide the other Party with a copy of this Agreement marked to show provisions for which such Party or its Affiliate intends to seek confidential treatment and shall reasonably consider and incorporate the other Party’s timely comments thereon to the extent consistent with the legal requirements, with respect to the filing Party or Affiliate, governing disclosure of material agreements and material information that must be publicly filed.

12.4 Technical Publication. Neither Party may publish peer reviewed manuscripts, or give other forms of public disclosure such as abstracts and presentations, of results of studies carried out under this Agreement or otherwise pertaining to the Development of the Vaccine or the Products in the Advaccine Territory, without the opportunity for prior review and comment by the other Party in accordance with this Section 12.4, except to the extent required by applicable Laws. A Party seeking publication shall provide the other Party the opportunity to review and comment on any such proposed publication at least five (5) calendar days for abstracts ten (10) calendar days for manuscripts prior to its intended submission for publication. The other Party shall provide the Party seeking publication with its comments in writing, if any, within three (3) calendar days for abstracts and seven (7) calendar days for manuscripts after receipt of such proposed publication. The Party seeking publication shall consider in good faith any comments thereto provided by the other Party and shall comply with the other Party’s request to remove any and all of such other Party’s Confidential Information from the proposed publication. Further, if Inovio reasonably determines and notifies Advaccine that a proposed publication is reasonably likely to result in Adverse Risk in the Inovio Territory, Advaccine shall not submit such publication unless and until the Parties agree to a proposal to mitigate such Adverse Risk. In addition, the Party seeking publication shall delay the submission for a period up to thirty (30) calendar days in the event that the other Party can demonstrate reasonable need for such delay for the preparation and filing of a patent application. If the other Party fails to provide its comments to the Party seeking publication within the specified time frame, such other Party shall be deemed to not have any comments, and the Party seeking publication shall be free to publish in accordance with this Section 12.4. The

Party seeking publication shall provide the other Party a copy of the manuscript at the time of the submission. Each Party agrees to acknowledge the contributions of the other Party and its employees in all publications in accordance with scientific practices.

12.5 Equitable Relief. Each Party acknowledges that its breach of this Article 12 will cause irreparable harm to the other Party, which cannot be reasonably or adequately compensated in damages in an action at law. By reasons thereof, each Party agrees that the other Party shall be entitled, in addition to any other remedies it may have under this Agreement or otherwise, to preliminary and permanent injunctive and other equitable relief to prevent or curtail any actual or threatened breach of the obligations relating to Confidential Information set forth in this Article 12 by the other Party.

ARTICLE 13
TERM AND TERMINATION

13.1 Term. The term of this Agreement (the “Term”) shall commence upon the Prior Effective Date and, unless earlier terminated pursuant to this Article 13, shall remain in effect until the expiration of the Royalty Term on a Region-by-Region basis. Upon the expiration (but not early termination) of this Agreement, on a Region-by-Region basis, the licenses granted hereunder by Inovio to Advaccine shall become fully paid-up and royalty free; provided that such licenses shall thereafter be granted on a non-exclusive basis.

13.2 Termination by Advaccine. Advaccine may terminate this Agreement in its entirety for convenience upon (i) nine (9) months prior written notice to Inovio (if such notice is provided before the First Commercial Sale in any Region) or (ii) eighteen (18) months prior written notice to Inovio (if such notice is provided following the First Commercial Sale in any Region); provided, however, that in each case under (i) and (ii) Inovio may, in its discretion, upon prior written notice to Advaccine accelerate the effectiveness of such termination to the extent permitted by Law in the Advaccine Territory.

13.3 Termination by Inovio.

(a)Inovio may terminate this Agreement upon written notice to Advaccine, if Advaccine ceases all Development (including all regulatory activities) or all Commercialization of the Products (including through Sublicensees and contractors) in the Advaccine Territory for a period of nine (9) or more consecutive months, unless Development or Commercialization of the Products was prevented throughout such period by a force majeure for which Advaccine provided notice pursuant to Section 15.2 prior to or at the start of such period and that persisted throughout such period despite Advaccine’s Commercially Reasonable Efforts to remove or mitigate it. Such termination shall go into effect on the date specified in the applicable termination notice. For clarity, a delay by Regulatory Authorities and/or a decision by Regulatory Authorities to suspend a Clinical Trial (e.g., a “regulatory hold”) shall not give Inovio the right to terminate this Agreement under this Section 13.3(a), so long as Advaccine continues to use Commercially Reasonable Efforts to remove such regulatory hold.

(b)Inovio may terminate this Agreement in its entirety upon thirty (30) days’ prior written notice to Advaccine, if Advaccine or its Affiliates or their respective Sublicensees

(directly or indirectly, individually or in association with any other Person) challenges the validity, enforceability or scope of any Inovio Licensed Patent, unless during such thirty (30)-day period the subject challenge is permanently dismissed or withdrawn and is not thereafter reinstituted or continued; provided that in the event a Sublicensee of Advaccine initiates such challenge, Inovio may not terminate this Agreement if (i) Advaccine successfully causes such Sublicensee to abort such challenge within such thirty (30)-day period, or (ii) Advaccine (A) provides Inovio a written notice of its intent to terminate its sublicense with such Sublicensee within such thirty (30)-day period, and (B) successfully terminates such sublicense within such thirty (30)-day period.

13.4 Termination for Breach. Each Party shall have the right to terminate this Agreement in its entirety immediately upon written notice to the other Party if the other Party materially breaches its obligations under this Agreement (including, with respect to Advaccine, any failure to make a payment under Section 8.1(b) (whether to Inovio or directly to any Third Party service provider) when due) and, after receiving written notice identifying such material breach in reasonable detail, fails to cure such material breach within ninety (90) (or thirty (30) days in case of failure to make a payment due under this Agreement for reasons other than that set forth in Section 8.6) days from the date of such notice; provided that, if either Party disputes (a) whether such material breach has occurred, or (b) whether the defaulting Party has cured such material breach, the Parties agree to resolve the dispute as expeditiously as possible under Article 14. It is understood and acknowledged that during the pendency of such a dispute, all of the terms and conditions of this Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations hereunder. Each Party hereby acknowledges that as of the Effective Date such Party is not aware of any material breach by the other Party or any other events of termination under Section 13.3 and 13.5 of the Prior Agreement. Notwithstanding the foregoing, in the event of any failure by Advaccine to make a payment under Section 8.1(b) (whether to Inovio or directly to any Third Party service provider) when due), Inovio’s right to terminate this Agreement shall not include the territory of Greater China, rather such termination right shall be limited to the Advaccine Territory (other than Greater China).

13.5 Termination Due to Bankruptcy. Either Party may terminate this Agreement if, at any time, the other Party files in any court or agency pursuant to any statute or regulation of any state, country or jurisdiction, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of that Party or of its assets, or if the other Party proposes a written agreement of composition or extension of its debts, or if the other Party is served with an involuntary petition against it, filed in any insolvency proceeding, and such petition is not dismissed within sixty (60) days after the filing thereof, or if the other Party proposes or becomes a Party to any dissolution or liquidation, or if the other Party makes an assignment for the benefit of its creditors (each, an “Insolvency Event”).

13.6 Effect of Termination. Upon any termination of this Agreement, the following shall apply (in addition to any other rights and obligations under this Agreement with respect to such termination):

(a)Licenses. All licenses and other rights granted by Inovio to Advaccine under this Agreement shall terminate. Inovio shall have a reversion of all rights previously

licensed to Advaccine hereunder for which the relevant licenses have terminated on a fully paid-up and royalty-free basis, itself or with or through an Affiliate or Third Party, to Develop and Commercialize the Products in the Field in the Advaccine Territory at Inovio’s discretion.

(b)Wind-Down. Advaccine will (i) responsibly wind-down, in accordance with accepted pharmaceutical industry norms and ethical practices, any on-going Clinical Trials for which it has responsibility hereunder in which patient dosing has commenced or, (ii) unless if this Agreement is terminated by Advaccine pursuant to Sections 13.4 or 13.5, at Inovio’s reasonable request, (A) transfer to Inovio of its designee such Clinical Trial to the extent permitted under applicable Laws and accepted pharmaceutical industry norms and ethical practices, or (B) if reasonably practicable and not adverse to patient safety, complete such Clinical Trials and Inovio shall reimburse Advaccine its reasonable, out-of-pocket costs associated therewith. For clarity, except as provided for above, Advaccine may transfer to Inovio or its designee or wind-down any ongoing Clinical Trials prior to the date of termination in accordance with accepted pharmaceutical industry norms and ethical practices and Advaccine will be responsible for any costs associated with such transfer or wind-down. Notwithstanding the foregoing, if this Agreement is terminated by Advaccine pursuant to Sections 13.4 or 13.5, then Inovio will be responsible for any costs associated with such wind-down.

(c)Regulatory Materials; Data. Except if this Agreement is terminated by Advaccine pursuant to Sections 13.4 or 13.5, Advaccine shall (i) provide and assign to Inovio or its designee all Regulatory Materials, including Regulatory Approvals, for the Products to the extent possible under applicable Laws in the Advaccine Territory, (ii) promptly provide to Inovio all Data (to the extent not already provided to Inovio), including pharmacovigilance data, generated by or on behalf of Advaccine, and (iii) promptly return or destroy, at Inovio’s election, all Confidential Information of Inovio.

(d)Trademarks. Except if this Agreement is terminated by Advaccine pursuant to Sections 13.4 or 13.5, upon Inovio’s written request, Advaccine shall grant to Inovio, effective as of the date of such request, an exclusive, transferable, fully paid-up, royalty free, sublicensable license to use Advaccine Product Marks in connection with the Commercialization of the Products in the Advaccine Territory (and excluding, for clarity, any Advaccine Housemarks).

(e)Transition Assistance. Upon Inovio’s reasonable request, (i) Advaccine shall provide such assistance as may be reasonably necessary or useful for Inovio to continue the Development and Commercialization of the Products in the Advaccine Territory, to the extent Advaccine or its Affiliate is then performing or having performed such activities, including upon the reasonable request of Inovio, assigning (to the extent Advaccine has rights to assign) or using Commercially Reasonable Efforts to amend as appropriate any agreements or arrangements Advaccine or its Affiliate have with any Third Party for the Development, distribution, sale or otherwise Commercialization of the Products; and (ii) Advaccine shall provide Inovio with copies of any promotional and marketing materials generated by or on behalf of Advaccine with respect to the Products prior to the effective date of termination. If this Agreement is terminated by Advaccine pursuant to Sections 13.4 or 13.5, Inovio shall bear all costs arising out of any of

the transition assistance activities set forth in clause (i) or (ii) performed by Advaccine. If this Agreement is terminated by Advaccine pursuant to Section 13.2 or by Inovio pursuant to Sections 13.3, 13.4, or 13.5, Advaccine shall bear all costs arising out of any of the transition assistance activities set forth in clause (i) or (ii) performed by Advaccine.

(f)Inventory. In the event that this Agreement is terminated in its entirety, Inovio shall have the right, but not the obligation, to purchase any and all of the inventory of the Products held by Advaccine or its Affiliates as of the date of termination, at a price equal to the transfer price paid by Advaccine to Inovio for such inventory. Notwithstanding the foregoing, if this Agreement is terminated by Advaccine pursuant to Sections 13.4 or 13.5, upon Advaccine’s request, at its sole discretion, Inovio shall re-purchase any and/or all of its inventory of the Products, at a price equal to the transfer price paid by Advaccine to Inovio (if supplied by Inovio) or Advaccine’s manufacturing cost (if manufactured by Advaccine or its subcontractor) therefor. Advaccine shall also have the right to continue to be permitted to sell such inventory for up to at least twelve (12) months after the effective date of termination of this Agreement.

13.7 Survival. Any expiration or termination of this Agreement shall not affect rights or obligations of the Parties under this Agreement that have accrued prior to the date of expiration or termination (including with respect to any payments that have accrued prior to the effective date of expiration or termination of this Agreement). Notwithstanding anything to the contrary, the following provisions shall survive any expiration or termination of this Agreement: Sections 2.4, 4.5, 8.5 through 8.9 (inclusive), 9.1(a), 9.1(b), 9.1(d), 10.6, 13.6, 13.7 and 13.8 and Articles 1, 11, 12, 14 and 15.

13.8 Termination Not Sole Remedy. Termination is not the sole remedy under this Agreement and, whether or not termination is effected and notwithstanding anything contained in this Agreement to the contrary, all other remedies shall remain available except as agreed to otherwise herein.

ARTICLE 14
DISPUTE RESOLUTION

14.1 Disputes; Internal Resolution. The Parties recognize that disputes as to certain matters may from time to time arise that relate to either Party’s rights and/or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation. To accomplish this objective, the Parties agree that, except as otherwise provided in Section 3.2(d), if a dispute arises under or relates to this Agreement, including, without limitation, any alleged breach under this Agreement or any issue relating to the interpretation or application of this Agreement, and the Parties are unable to resolve such dispute within thirty (30) days after such dispute is first identified by either Party in writing to the other, the Parties shall refer such dispute to a senior executive of each of Inovio (or one of its Affiliates) and Advaccine (the “Executive Officers”) for attempted resolution by good faith negotiations within thirty (30) days after notice referring to the dispute is received. If the dispute is not resolved within such thirty (30) days, then the dispute shall be resolved by arbitration in accordance with Section 14.2 and

thereafter neither Party shall have any further obligation under this Section 14.1. Notwithstanding the foregoing, and without waiting for the expiration of any such thirty (30)-day periods, each Party shall each have the right to apply to any court of competent jurisdiction for appropriate interim or provisional relief, as necessary to protect the rights or property of such Party.

14.2 Arbitration. All disputes arising out of or in connection with this Agreement, including any questions regarding its formation, existence, validity or termination, or the scope or applicability of this agreement to arbitrate, shall be referred to and finally resolved by arbitration administered by the Singapore International Arbitration Centre (“SIAC”) under the Arbitration Rules of the Singapore International Arbitration Centre (“SIAC Rules”) for the time being in force and as may be amended by the rest of this clause.

(a)The seat, or legal place, of arbitration shall be the Republic of Singapore. There shall be three (3) arbitrators, with two (2) arbitrators to be respectively nominated by each Party and the third (presiding) arbitrator to be appointed by SIAC. The language of the arbitration shall be English.

(b)Any decision or arbitral award of SIAC shall be final and binding on each Party. If any Party fails to implement the final arbitral award, the other Party may file an application for the enforcement of the arbitral award to a court with competent jurisdiction. The costs of arbitration shall be borne by the losing Party or as otherwise determined by the arbitral tribunal.

(c)In the course of arbitration, the Parties shall make Commercially Reasonable Efforts to continue to implement the Agreement except for those matters subject to arbitration.

(d)Each Party retains the right to apply to any court of competent jurisdiction for interim and/or conservatory measures, including pre-arbitral attachments or preliminary injunctions, and any such request shall not be deemed incompatible with, or a waiver of, this agreement to arbitrate.

(e)The existence and content of the arbitral proceedings and any rulings or awards shall be kept confidential by the Parties and members of the arbitral tribunal except (i) to the extent that disclosure may be required of a Party to fulfill a legal duty, protect or pursue a legal right, or enforce or challenge an award in bona fide legal proceedings before a state court or other judicial authority, (ii) with the consent of all Parties, (iii) where needed for the preparation or presentation of a claim or defense in this arbitration, (iv) where such information is already in the public domain other than as a result of a breach of this clause, or (v) by order of the arbitral tribunal upon application of a Party.

(f)For avoidance of doubt, nothing contained in this Section 14.2 shall operate as a restriction on a Party's rights to terminate this Agreement pursuant to Article 13.

14.3 Governing Law. This Agreement shall be governed by and construed under, and all disputes arising under or in connection with this Agreement shall be resolved in accordance with,

the laws of the State of New York, U.S., without regard to the conflicts of law provisions thereof. The United Nations Convention on International Contracts on the Sale of Goods does not apply to this Agreement and is expressly and entirely excluded.

ARTICLE 15
MISCELLANEOUS

15.1 Entire Agreement; Amendment. This Agreement, including the Schedules and Exhibits hereto, sets forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto with respect to the subject matter hereof and supersedes, as of the Effective Date, all prior and contemporaneous agreements and understandings between the Parties with respect to the subject matter hereof (other than the Non-Exclusive License Agreement, and that certain Research Service Contract dated December 30, 2020), including the Prior Agreement. The foregoing shall not be interpreted as a waiver of any remedies available to either Party as a result of any breach, prior to the Effective Date, by the other Party of its obligations under the Confidentiality Agreement or the Prior Agreement. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth in this Agreement. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.

15.2 Force Majeure. Both Parties shall be excused from the performance of their obligations under this Agreement to the extent that such performance is prevented by force majeure and the nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse shall be continued only for so long as (a) the condition constituting force majeure continues and (b) the nonperforming Party takes all reasonable efforts to remove the condition. For purposes of this Agreement, force majeure shall include conditions beyond the reasonable control of the applicable Party, which may include an act of God, war, civil commotion, terrorist act, labor strike or lock-out, epidemic, pandemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe, action or inaction of any Governmental Authority, and failure of plant or machinery. Notwithstanding the foregoing, a Party shall not be excused from making payments owed hereunder because of a force majeure affecting such Party. If a force majeure persists for more than ninety (90) days, then the Parties will discuss in good faith the modification of the Parties’ obligations under this Agreement in order to mitigate the delays caused by such force majeure.

15.3 Notices. Any notice required or permitted to be given under this Agreement shall be in writing, shall specifically refer to this Agreement, and shall be addressed to the appropriate Party at the address specified below or such other address as may be specified by such Party in writing in accordance with this Section 15.3, and shall be deemed to have been given for all purposes (a) when received, if hand-delivered or sent by a reputable courier service, (b) five (5) Business Days after mailing, if mailed by first class certified or registered airmail, postage prepaid, return receipt requested, or (c) if sent by electronic mail, upon electronic confirmation of receipt.

If to Inovio: Inovio Pharmaceuticals, Inc.

600 W. Germantown Pike, Suite 110

Plymouth Meeting, PA 19462

Attn: [***]

Email : [***]

with copies to (which shall not constitute notice):

Inovio Pharmaceuticals, Inc.

600 W. Germantown Pike, Suite 110

Plymouth Meeting, PA 19462

Attn: [***]

Email : [***]

and

Cooley LLP
500 Boylston Street
Boston, MA 02116-3737
USA

Attn: [***]

Email : [***]

If to Advaccine: Advaccine Biopharmaceuticals Suzhou Co., Ltd.

18 Qingqiu Road

Suzhou, China

Attn: [***]

Email : [***]

with copies to (which shall not constitute notice):

[***]

Partner

Sidley Austin LLP

Suite 608, Tower C2

Oriental Plaza, Beijing

1000738 China

Email: [***]

15.4 No Strict Construction; Headings. This Agreement has been prepared jointly by the Parties and shall not be strictly construed against either Party. Ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision. The headings of each Article and Section in this Agreement have

been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Article or Section. Except where the context otherwise requires, the use of any gender shall be applicable to all genders, and the word “or” is used in the inclusive sense (and/or). The term “including” as used herein means including, without limiting the generality of any description preceding such term.

15.5Assignment; Change of Control.

(a)Except as provided in Section 15.5(b), this Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred, by either Party without the prior written consent of the other Party. Any attempted assignment not in accordance with the foregoing shall be null and void and of no legal effect. Any permitted assignee shall assume all assigned obligations of its assignor under this Agreement. The terms and conditions of this Agreement shall be binding upon, and shall inure to the benefit of, the Parties and their respected successors and permitted assigns.

(b)Notwithstanding the foregoing, Inovio may, without the consent of Advaccine, (i) assign this Agreement and its rights and obligations hereunder in whole or in part to an Affiliate of Inovio, or in whole to its successor-in-interest in connection with the sale of all or substantially all of its stock or its assets to which this Agreement relates, or in connection with a merger, acquisition or similar transaction; (ii) sell or otherwise assign to any Third Party Inovio’s right to receive any payment (or portion thereof) from Advaccine under this Agreement, and/or (iii) grant a security interest in its rights, title and interest in, to and under this Agreement. If Inovio sells or assigns to any Third Party a right to receive a portion or all of its payments under this Agreement, such Third Party shall also have the right to receive the information received by Inovio pursuant to this Agreement and to conduct audits in accordance with Section 8.8 and Advaccine shall, at Inovio’s request, cooperate to facilitate the provision of any such information and the payment of any such amounts directly to such Third Party.

(c)Notwithstanding the foregoing, Advaccine may without consent of Inovio, assign this Agreement or delegate its rights and obligations hereunder in whole or in part to an Affiliate of Advaccine (provided that in such case, Advaccine shall inform Inovio of such assignment or delegation and remain responsible for the performance of its Affiliate under this Agreement), or in whole to its successor-in-interest in connection with the sale of all or substantially all of its stock or its assets to which this Agreement relates, or in connection with a merger, acquisition or similar transaction.

15.6 Performance by Affiliates. Each Party may discharge any obligations and exercise any right hereunder through any of its Affiliates. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement, and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Agreement shall be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate.

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

15.8 Severability. If any one or more of the provisions of this Agreement is held to be invalid or unenforceable by an arbitral tribunal constituted in accordance with Section 14.2, the provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. The Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.

15.9 No Waiver. Any delay in enforcing a Party’s rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, except with respect to an express written and signed waiver relating to a particular matter for a particular period of time.

15.10 Independent Contractors. Each Party shall act solely as an independent contractor, and nothing in this Agreement shall be construed to give either Party the power or authority to act for, bind, or commit the other Party in any way. Nothing herein shall be construed to create the relationship of partners, principal and agent, or joint-venture partners between the Parties.

15.11 English Language. This Agreement was prepared in the English language, which language shall govern the interpretation of, and any dispute regarding, the terms of this Agreement.

15.12 Counterparts. This Agreement may be executed in one (1) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may be executed via electronic signature or via the exchange of signed portable document format (“PDF”) versions of this Agreement. Such electronic signatures, and signatures on PDF versions of this Agreement, will be considered the legally binding equivalent of wet-ink, original, hand-written signatures.

15.13 Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11 of the U.S. Code and other similar laws in any jurisdiction outside the U.S. (collectively, the “Bankruptcy Laws”), licenses of rights to “intellectual property” as defined under the Bankruptcy Laws. Upon the occurrence of any Insolvency Event with respect to a Party (the “Insolvent Party”), the Insolvent Party agrees that the other Party (the “Non-Insolvent Party”), as licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Laws. Each Party shall, during the Term, create and maintain current copies or, if not amenable to copying, detailed descriptions or other appropriate embodiments, to the extent feasible, of all such intellectual property. Each Party agrees and acknowledges that “embodiments” of intellectual property within the meaning of Section 365(n) include, without limitation, laboratory notebooks, cell lines, product samples and inventory, research studies and data, Regulatory Approvals and Regulatory Materials, in each case to the extent related to the Products. If (i) a case is commenced during the Term by or against a Party

under the Bankruptcy Laws, (ii) this Agreement is rejected as provided for under the Bankruptcy Laws, and (iii) the Non-Insolvent Party elects to retain its rights hereunder as provided for under the Bankruptcy Laws, then the Insolvent Party (in any capacity, including debtor-in-possession) and its successors and assigns (including a Title 11 trustee), shall (x) provide to the Non-Insolvent Party immediately upon the Non-Insolvent Party’s written request copies of all such intellectual property (including embodiments thereof) held by the Insolvent Party and such successors and assigns, or otherwise available to them, and (y) not interfere with the Non-Insolvent Party’s rights under this Agreement, or any related agreements between the Parties, to such intellectual property (including such embodiments), including any right to obtain such intellectual property (or such embodiments) from another entity, to the extent provided in the Bankruptcy Laws. Whenever the Insolvent Party or any of its successors or assigns provides to the Non-Insolvent Party any of the intellectual property licensed hereunder (or any embodiment thereof) pursuant to this Section 15.13, the Non-Insolvent Party shall have the right to perform the Insolvent Party’s obligations hereunder with respect to such intellectual property, but neither such provision nor such performance by the Non-Insolvent Party shall release the Insolvent Party from liability resulting from rejection of the license or the failure to perform such obligations. All rights, powers and remedies of the Non-Insolvent Party as provided herein are in addition to and not in substitution for any and all other rights, powers and remedies now or hereafter existing at law or in equity (including the Bankruptcy Laws) in the event of the commencement of a case by or against a Party under the Bankruptcy Laws. In particular, it is the intention and understanding of the Parties that the rights granted to the Parties under this Section 15.13 are essential to the Parties’ respective businesses and the Parties acknowledge that damages are not an adequate remedy. The Parties agree that they intend the following rights to extend to the maximum extent permitted by applicable Laws, and to be enforceable under Section 365(n) of Title 11 of the U.S. Code: (A) the right of access to any intellectual property (including embodiments thereof) of the Insolvent Party, or any Third Party with whom the Insolvent Party contracts to perform an obligation of the Insolvent Party under this Agreement, and, in the case of the Third Party, which is necessary for the Development, Manufacture and Commercialization of Products; and (B) the right to contract directly with any Third Party to complete the contracted work upon failure of the Insolvent Party to comply with its applicable obligations.

{Signature Page Follows}

In Witness Whereof, the Parties have executed this Collaboration and License Agreement in duplicate originals by their duly authorized officers as of the Effective Date.


Inovio Pharmaceuticals, Inc. By: /s/ J. Joseph Kim Name: J. Joseph Kim, PhD Title: President & CEO			Advaccine Biopharmaceuticals Suzhou Co., Ltd. By: /s/ Jane Yu Name: Jane Yu Title: President

LIST OF EXHIBITS

Schedule 1.4: Advaccine Territory

Schedule 1.39: Global Phase 3 Study

Schedule 1.40: Global Phase 3 Study Plan

Exhibit A: Inovio Licensed Patents

Exhibit B: Inovio Licensed Know-How

Schedule 1.4

Advaccine Territory


1.Kazakhstan 2.Uzbekistan 3.Turkmenistan 4.Tajikistan 5.Kyrgyz Republic 6.Afghanistan 7.Mongolia 8.Bangladesh 9.Sri Lanka 10.Nepal 11.Maldives 12.Bhutan			13. Indonesia 14. Thailand 15. Philippines 16. Vietnam 17. Singapore 18. Malaysia 19. Myanmar 20. Cambodia 21. Laos 22. Brunei 23. Timor-Leste			24. Iraq 25. Jordan 26. Azerbaijan 27. Cyprus 28. Yemen 29. Lebanon 30. Georgia 31. Armenia 32. Pakistan 33. Turkey

Schedule 1.39

Global Phase 3 Study

[***]

Schedule 1.40

Global Phase 3 Study Plan

[***]

Exhibit A

Inovio Licensed Patents

[***]

Exhibit B

Inovio Licensed Know-How

[***]

Exhibit 31.1

Certification of CEO Pursuant to

Securities Exchange Act Rules 13a-15(e) and 15d-15(e)

as Adopted Pursuant to

Section 302 of the Sarbanes-Oxley Act of 2002

I, J. Joseph Kim, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Inovio Pharmaceuticals, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.


Date:	August 9, 2021	/s/ J. JOSEPH KIM
		J. Joseph Kim President, Chief Executive Officer and Director (Principal Executive Officer)

Exhibit 31.2

Certification of CFO Pursuant to

Securities Exchange Act Rules 13a-15(e) and 15d-15(e)

as Adopted Pursuant to

Section 302 of the Sarbanes-Oxley Act of 2002

I, Peter Kies, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Inovio Pharmaceuticals, Inc.;

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.


Date:	August 9, 2021	/s/ PETER KIES
		Peter Kies Chief Financial Officer (Principal Financial and Accounting Officer)

Exhibit 32.1

Certification Pursuant to

18 U.S.C. Section 1350,

As Adopted Pursuant to

Section 906 of the Sarbanes-Oxley Act of 2002

In connection with the quarterly report of Inovio Pharmaceuticals, Inc. (the “Company”) on Form 10-Q for the quarter ending June 30, 2021, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned, in the capacities and on the date indicated below, hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.


Date:	August 9, 2021	/s/ J. JOSEPH KIM
		J. Joseph Kim President, Chief Executive Officer and Director (Principal Executive Officer)

Date:	August 9, 2021	/s/ PETER KIES
		Peter Kies Chief Financial Officer (Principal Financial and Accounting Officer)

The foregoing certification is being furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and is not filed with the Securities and Exchange Commission as part of the Form 10-Q or as a separate disclosure document and is not incorporated by reference into any filing of Inovio Pharmaceuticals, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, irrespective of any general incorporation language contained in such filing. A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.