10-Q

Vaxart, Inc. (VXRT)

10-Q 2025-11-13 For: 2025-09-30
View Original
Added on April 07, 2026

Table of Contents



UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

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

For the quarterly period ended September 30, 2025

OR

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

For the transition period from                      to

Commission file number: 00 1 - 3 52 8 5

Vaxart , Inc.
(Exact Name of Registrant as Specified in its Charter)
Delaware 5 9 - 1212264
--- ---
(State or other jurisdiction of incorporation or organization) (IRS Employer Identification No.)
170 Harbor Way , Suite 300 , South San Francisco, CA 94 080 ( 6 50 ) 550 - 3 5 0 0
--- ---
(Address of principal executive offices, including zip code) (Registrant’s telephone number, including area code)
N/A
---
(Former Name, Former Address and Former Fiscal Year,<br> <br>if Changed Since Last Report)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading symbol Name of each exchange on which registered
Common Stock, $0.0001 par value VXRT *

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, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

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 Exchange Act).   Yes ☐   No ☑

The Registrant had 240,069,844 shares of common stock, $0.0001 par value, outstanding as of November 6, 2025.

* The registrant’s common stock trades exclusively on the OTCQX® Best Market under the symbol “VXRT.”




Table of Contents

FORM 10-Q

FOR THE QUARTER ENDED September 30, 2025

TABLE OF CONTENTS

Page
Part I FINANCIAL INFORMATION 1
Item 1. Financial Statements (Unaudited) 1
Condensed Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024 1
Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2025 and 2024 2
Condensed Consolidated Statements of Stockholders’ Equity for the three and nine months ended September 30, 2025 and 2024 3
Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2025 and 2024 5
Notes to the Condensed Consolidated Financial Statements 6
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 23
Item 3. Quantitative and Qualitative Disclosures About Market Risk 37
Item 4. Controls and Procedures 37
Part II OTHER INFORMATION 38
Item 1. Legal Proceedings 38
Item 1A. Risk Factors 38
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 39
Item 3. Defaults Upon Senior Securities 39
Item 4. Mine Safety Disclosures 39
Item 5. Other Information 39
Item 6. Exhibits 40
SIGNATURES 42

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FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (this “Quarterly Report”) for the quarterly period ended September 30, 2025, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are subject to the “safe harbor” created by those sections, concerning our business, operations, and financial performance and condition as well as our plans, objectives, and expectations for business operations and financial performance and condition. Any statements contained herein that are not of historical facts may be deemed to be forward-looking statements. You can identify these statements by words such as “anticipate,” “assume,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “should,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends. These forward-looking statements are based on current expectations, estimates, forecasts, and projections about our business and the industry in which we operate and management’s beliefs and assumptions and are not guarantees of future performance or development and involve known and unknown risks, uncertainties, and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this Quarterly Report may turn out to be inaccurate. Factors that could materially affect our business operations and financial performance and condition include, but are not limited to, those risks and uncertainties described herein under “Item 1A. Risk Factors.” and those described in our Annual Report on Form 10-K for the year ended December 31, 2024, under “Item 1A. Risk Factors.” You are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are based on information available to us as of the filing date of this Quarterly Report. Unless required by law, we do not intend to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise. You should, however, review the risk factors we describe in the reports we will file from time to time with the Securities and Exchange Commission (the “SEC”) after the date of this Quarterly Report.

This Quarterly Report also contains market data related to our business and industry. These market data include projections that are based on a number of assumptions. If these assumptions turn out to be incorrect, actual results may differ from the projections based on these assumptions. As a result, our markets may not grow at the rates projected by these data, or at all. The failure of these markets to grow at these projected rates may harm our business, results of operations, financial condition and the market price of our common stock.


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PART IFINANCIAL INFORMATION

Item 1.  Financial Statements

VAXART, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts )

(Unaudited)

December 31, 2024
Assets **** ****
Current assets:
Cash and cash equivalents 16,880 $ 25,229
Short-term investments 11,913 26,494
Accounts receivable 42,716 5,761
Unbilled receivable from government contracts 43,229 6,208
Prepaid expenses and other current assets 2,632 4,568
Total current assets 117,370 68,260
Property and equipment, net 6,064 8,705
Prepaid clinical services, long-term 60,116 60,116
Right-of-use assets, net 17,097 20,404
Intangible assets, net 3,009 3,557
Goodwill 4,508 4,508
Other long-term assets 824 839
Total assets 208,988 $ 166,389
Liabilities and Stockholders’ Equity **** ****
Current liabilities:
Accounts payable 53,075 $ 6,963
Deferred government revenue 64,828 65,400
Other accrued current liabilities 44,882 11,378
Current portion of operating lease liability 3,783 3,077
Current portion of liability related to sale of future royalties 2,732 4,060
Total current liabilities 169,300 90,878
Operating lease liability, net of current portion 11,661 14,449
Liability related to sale of future royalties, net of current portion 782 1,698
Other long-term liabilities 489 439
Total liabilities 182,232 107,464
Commitments and contingencies (Note 7)
Stockholders’ equity:
Preferred stock: 0.0001 par value; 5,000,000 shares authorized; none issued and outstanding as of September 30, 2025 and December 31, 2024
Common stock: 0.0001 par value; 350,000,000 shares authorized as of September 30, 2025 and December 31, 2024; 229,471,907 shares issued and 228,957,259 shares outstanding as of September 30, 2025 and 228,203,822 shares issued and 227,774,275 shares outstanding as of December 31, 2024 23 23
Additional paid-in capital 542,346 535,770
Treasury stock at cost, 514,648 shares as of September 30, 2025 and 429,547 shares as of December 31, 2024 (371 ) (350 )
Accumulated deficit (515,240 ) (476,522 )
Accumulated other comprehensive income (loss) (2 ) 4
Total stockholders’ equity 26,756 58,925
Total liabilities and stockholders’ equity 208,988 $ 166,389

All values are in US Dollars.

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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VAXART, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)

Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
Revenue:
Non-cash royalty revenue related to sale of future royalties $ $ 40 $ 1,579 $ 662
Revenue from government contracts 72,413 4,893 131,440 12,853
Total revenue 72,413 4,933 133,019 13,515
Operating expenses:
Research and development 75,947 15,066 156,426 51,559
General and administrative 4,277 4,342 13,942 16,757
Total operating expenses 80,224 19,408 170,368 68,316
Operating loss (7,811 ) (14,475 ) (37,349 ) (54,801 )
Other income (expense):
Interest income 302 1,022 1,049 1,941
Non-cash interest expense related to sale of future royalties (608 ) (631 ) (2,277 ) (2,045 )
Other income (expense), net (7 ) 22 (9 ) 26
Loss before income taxes (8,124 ) (14,062 ) (38,586 ) (54,879 )
Provision for income taxes 17 18 132 84
Net loss $ (8,141 ) $ (14,080 ) $ (38,718 ) $ (54,963 )
Net loss per share - basic and diluted $ (0.04 ) $ (0.06 ) $ (0.17 ) $ (0.28 )
Shares used to compute net loss per share - basic and diluted 228,926,340 227,452,883 228,405,929 193,655,660
Comprehensive loss: **** **** **** ****
Net loss $ (8,141 ) $ (14,080 ) $ (38,718 ) $ (54,963 )
Unrealized gain (loss) on available-for-sale investments, net of tax 5 43 (6 ) 28
Comprehensive loss $ (8,136 ) $ (14,037 ) $ (38,724 ) $ (54,935 )

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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VAXART, INC. AND SUBSIDIARIES

Condensed Consolidated Statement s of Stockholders’ Equity

For the Three and Nine Months Ended September 30, 2025

(In thousands, except share amounts)

(Unaudited)

**** **** **** **** Accumulated ****
**** **** Additional **** Other Total
Treasury Stock Paid-in Accumulated Comprehensive Stockholders’
Three Months Ended September 30, 2025 Amount Shares Amount Capital Deficit Gain (Loss) Equity
Balances as of June 30, 2025 229,417,137 $ 23 (504,574 ) $ (367 ) $ 540,328 $ (507,099 ) $ (7 ) $ 32,878
Release of common stock for vested restricted stock units 54,770
Repurchase of common stock to satisfy tax withholding (10,074 ) (4 ) (4 )
Stock-based compensation 2,018 2,018
Unrealized gain on available-for-sale investments 5 5
Net loss (8,141 ) (8,141 )
Balances as of September 30, 2025 229,471,907 $ 23 (514,648 ) $ (371 ) $ 542,346 $ (515,240 ) $ (2 ) $ 26,756
Nine Months Ended September 30, 2025
Balances as of December 31, 2024 228,203,822 $ 23 (429,547 ) $ (350 ) $ 535,770 $ (476,522 ) $ 4 $ 58,925
Issuance of common stock under June 2025 ATM, net of offering costs of 174 382,700 53 53
Issuance of common stock upon exercise of stock options 3,625 3 3
Issuance of treasury stock under ESPP 215,586 157 (78 ) 79
Release of common stock for vested restricted stock units 881,760
Repurchase of common stock to satisfy tax withholding (300,687 ) (178 ) (178 )
Stock-based compensation 6,598 6,598
Unrealized loss on available-for-sale investments (6 ) (6 )
Net loss (38,718 ) (38,718 )
Balances as of September 30, 2025 229,471,907 $ 23 (514,648 ) $ (371 ) $ 542,346 $ (515,240 ) $ (2 ) $ 26,756

All values are in US Dollars.

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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VAXART, INC. AND SUBSIDIARIES

Condensed Consolidated Statement s of Stockholders’ Equity

For the Three and Nine Months Ended September 30, 2024

(In thousands, except share amounts)

(Unaudited)

**** **** **** **** Accumulated ****
**** **** Additional **** Other Total
Treasury Stock Paid-in Accumulated Comprehensive Stockholders’
Three Months Ended September 30, 2024 Amount Shares Amount Capital Deficit (Loss) Gain Equity
Balances as of June 30, 2024 228,119,936 $ 23 (688,331 ) $ (565 ) $ 531,029 $ (450,457 ) $ (16 ) $ 80,014
Additional offering costs under the June 2024 Offering - - (10 ) (10 )
Issuance of common stock upon exercise of stock options 11,050 9 9
Release of common stock for vested restricted stock units 45,460 -
Repurchase of common stock to satisfy tax withholding (11,791 ) (9 ) (9 )
Stock-based compensation 2,475 2,475
Unrealized gain on available-for-sale investments 43 43
Net loss (14,080 ) (14,080 )
Balances as of September 30, 2024 228,176,446 $ 23 (700,122 ) $ (574 ) $ 533,503 $ (464,537 ) $ 27 $ 68,442
Nine Months Ended September 30, 2024
Balances as of December 31, 2023 153,959,853 $ 15 (507,020 ) $ (366 ) $ 467,731 $ (409,574 ) $ (1 ) $ 57,805
Issuance of common stock under the September 2021 ATM, net of offering costs of 248 7,719,641 1 8,801 8,802
Issuance of common stock under the 2024 Securities Purchase Agreement, net of offering costs of 55 15,384,615 2 9,943 9,945
Issuance of common stock under the June 2024 Offering, net of offering costs of 2,455 50,000,000 5 37,540 37,545
Issuance of common stock upon exercise of stock options 38,030 30 30
Issuance of common stock under ESPP 502,423 312 312
Stock-based compensation 9,146 9,146
Release of common stock for vested restricted stock units 571,884
Repurchase of common stock to satisfy tax withholding (193,102 ) (208 ) (208 )
Unrealized gains on available-for-sale investments 28 28
Net loss (54,963 ) (54,963 )
Balances as of September 30, 2024 228,176,446 $ 23 (700,122 ) $ (574 ) $ 533,503 $ (464,537 ) $ 27 $ 68,442

All values are in US Dollars.

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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VAXART, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

Nine Months Ended September 30,
2025 2024
Cash flows from operating activities: **** ****
Net loss $ (38,718 ) $ (54,963 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 6,524 6,614
Loss on disposal of assets 5
Net (accretion) amortization of (discounts) premiums on investments (207 ) (473 )
Stock-based compensation 6,598 9,146
Non-cash interest expense related to sale of future royalties 2,277 2,045
Non-cash revenue related to sale of future royalties (4,521 ) (3,596 )
Change in operating assets and liabilities:
Accounts receivable (36,955 ) 2,417
Unbilled receivable from government contracts (37,021 ) (3,085 )
Prepaid expenses and other assets 1,951 (1,170 )
Prepaid clinical services, long-term (60,116 )
Accounts payable 46,218 940
Deferred government revenue (572 ) 65,447
Other accrued liabilities 31,472 (625 )
Net cash used in operating activities (22,949 ) (37,419 )
Cash flows from investing activities: **** ****
Purchases of property and equipment (144 ) (510 )
Proceeds from sale of property and equipment 5
Purchases of investments (19,218 ) (48,717 )
Proceeds from maturities of investments 34,000 17,500
Net cash provided by (used in) investing activities 14,643 (31,727 )
Cash flows from financing activities: **** ****
Net proceeds from issuance of common stock in the June 2024 Offering 37,545
Net proceeds from issuance of common stock through at-the-market facilities 53 8,802
Net proceeds from issuance of common stock through the 2024 Securities Purchase Agreement 9,945
Proceeds from issuance of common stock upon exercise of stock options 3 30
Shares acquired to settle employee tax withholding liabilities (178 ) (208 )
Proceeds from issuance of common stock under the employee stock purchase plan 312
Proceeds from issuance of treasury stock under the employee stock purchase plan 79
Net cash (used in) provided by financing activities (43 ) 56,426
Net decrease in cash and cash equivalents (8,349 ) (12,720 )
Cash and cash equivalents at beginning of the period 25,229 34,755
Cash and cash equivalents at end of the period $ 16,880 $ 22,035
Supplemental disclosure of non-cash investing and financing activity:
--- --- --- --- ---
Acquisition of property and equipment included in accounts payable and accrued expenses $ $ 87

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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VAXART , INC. AND SUBSIDIARIES

Notes to the Condensed Consolidated Financial Statements (Unaudited)

NOTE 1.  Organization and Nature of Business

General

Vaxart Biosciences, Inc. was originally incorporated in California in March 2004, under the name West Coast Biologicals, Inc. The Company changed its name to Vaxart, Inc. (“Private Vaxart”) in July 2007, and reincorporated in the state of Delaware. In February 2018, Private Vaxart completed a business combination with Aviragen Therapeutics, Inc. (“Aviragen”), pursuant to which Aviragen merged with Private Vaxart, with Private Vaxart surviving as a wholly-owned subsidiary of Aviragen (the “Merger”). Pursuant to the terms of the Merger, Aviragen changed its name to Vaxart, Inc. (together with its subsidiaries, the “Company” or “Vaxart”) and Private Vaxart changed its name to Vaxart Biosciences, Inc.

In March 2025, the Company entered into an At the Market Offering Agreement (the “March 2025 ATM”) with Citizens JMP Securities, LLC (“Citizens”) and B. Riley Securities, Inc. (“B. Riley” and, together with Citizens, the “Managers”), pursuant to which the Company may offer and sell, from time to time through the Managers, shares of its common stock having an aggregate offering price of up to $50.0 million. The shares will be sold pursuant to an effective registration statement on Form S-3 (Registration Statement No. 333-270671) (the “2023 Shelf Registration Statement”), as previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The Company filed a prospectus supplement, dated March 21, 2025, with the SEC in connection with the offer and sale of the shares under the March 2025 ATM. The Company will pay the Managers a placement fee of up to 3% of the gross sale price from each sale of shares under the March 2025 ATM. During the nine months ended September 30, 2025, 382,700 shares were issued and sold under the March 2025ATM for gross proceeds of $0.2 million, which, after deducting sales commissions and expenses incurred to date, resulted in net proceeds of $0.1 million.

In June 2024, the Company entered into an underwriting agreement with Oppenheimer & Co. Inc., relating to the issuance and sale by the Company in an underwritten registered direct offering of 50,000,000 shares of the Company’s common stock, at a price of $0.80 per share. The gross proceeds to the Company from such offering were $40.0 million, and after deducting the underwriting discounts and commissions and estimated offering expenses payable by the Company, the net proceeds were $37.5 million.

In January 2024, the Company entered into a securities purchase agreement (the “2024 Securities Purchase Agreement”) with RA Capital Healthcare Fund, L.P. pursuant to which 15,384,615 shares of the Company's common stock were sold to RA Capital Healthcare Fund, L.P. at an offering price of $0.65 per share pursuant to the 2023 Shelf Registration Statement. The gross proceeds from the 2024 Securities Purchase Agreement were $10.0 million and, after deducting offering expenses, the net proceeds were $9.9 million.

The Company’s principal operations are based in South San Francisco, California, and it operates in one reportable segment, which is the discovery and development of oral recombinant protein vaccines, based on its proprietary oral vaccine platform.

NOTE 2.  Summary of Significant Accounting Policies

Basis of Presentation, Liquidity and Going Concern – The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the accounting and disclosure rules and regulations of the SEC assuming the Company will continue as a going concern.

The Company is a clinical-stage biotechnology company with no product sales. The Company’s primary source of financing is from the sale and issuance of common stock as well as funding from the Biomedical Advanced Research and Development Authority (“HHS BARDA”), a division of the Administration for Strategic Preparedness and Response (“ASPR”) within the United States (“U.S.”) Department of Health and Human Services. In the past, the Company has also financed its operations through the issuance of secured debt securities and preferred stock, proceeds from the exercise of warrants, and payments under collaboration and license agreements. As of September 30, 2025, the Company had cash, cash equivalents and short-term investments of $28.8 million. The Company’s cash, cash equivalents and investments are not sufficient to fund the Company’s planned operations for a period of 12 months from the date the unaudited condensed consolidated financial statements are issued.

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VAXART , INC. AND SUBSIDIARIES

Notes to the Condensed Consolidated Financial Statements (Unaudited)

The Company will be dependent upon raising additional capital through placement of its common stock, notes or other securities, borrowings, or entering into a partnership with a strategic party in order to implement its business plan. There can be no assurance that the Company will be successful raising additional capital in order to continue as a going concern.

Based on management’s current plan, including updated assumptions around the continued execution under the 2024 ATI-RRPV Contract, and considering events occurring after the balance-sheet date, the Company reassessed its liquidity and going-concern evaluation. On November 4, 2025, the Company entered into (i) an Exclusive License and Collaboration Agreement (the “License Agreement”) and (ii) a Securities Purchase Agreement (the “Purchase Agreement”) with Dynavax Technologies Corporation (“Dynavax”). Under the License Agreement, the Company granted Dynavax an exclusive, worldwide license to develop and commercialize its investigational oral COVID-19 vaccine candidate. Dynavax agreed to pay the Company an up-front license fee of

$25.0

million and, pursuant to the Purchase Agreement, to purchase

$5.0

million of the Company’s common stock at $0.45 per share. The Company received a total of approximately $30.0 million from these transactions. See Note 12. Together with the Company’s updated operating plan and ongoing cost-management initiatives, these proceeds extend the Company’s cash runway into the second quarter of 2027. Accordingly, management concluded that the conditions and events that previously raised substantial doubt about the Company’s ability to continue as a going concern have been alleviated. The accompanying unaudited condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business.

These unaudited condensed consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

The condensed consolidated balance sheet as of December 31, 2024, included in this document, was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. Certain information and footnote disclosures normally included in consolidated financial statements have been condensed or omitted pursuant to these rules and regulations. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and footnotes related thereto for the year ended December 31, 2024, included in the Company’s Annual Report on Form 10-K filed with the SEC on *March 20, 2025 (*the “Annual Report”). Unless noted below, there have been no material changes to the Company’s significant accounting policies described in Note 2 to the condensed consolidated financial statements included in the Annual Report. In the opinion of management, the unaudited condensed consolidated financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the Company’s financial position and the results of its operations and cash flows. The results of operations for such interim periods are not necessarily indicative of the results to be expected for the full year or any future periods.

Basis of Consolidation – The unaudited condensed consolidated financial statements include the financial statements of Vaxart, Inc. and its subsidiaries. All significant transactions and balances between Vaxart, Inc. and its subsidiaries have been eliminated in consolidation.

Use of Estimates – The preparation of financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and disclosure of contingent assets and liabilities in the condensed consolidated financial statements and accompanying notes. Actual results and outcomes could differ from these estimates and assumptions.

Concentration of Credit Risk – Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash, cash equivalents, available-for-sale investments and accounts receivable. The Company places its cash, cash equivalents and available-for-sale investments at financial institutions that the Company believes are of high credit quality. The Company is exposed to credit risk in the event of default by the financial institutions holding the cash and cash equivalents to the extent such amounts are in excess of the federally insured limits. Losses incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial condition, results of operations, and cash flows.

The primary focus of the Company’s investment strategy is to preserve capital and meet liquidity requirements. The Company’s investment policy addresses the level of credit exposure by limiting the concentration in any one corporate issuer or sector and establishing a minimum allowable credit rating.

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VAXART , INC. AND SUBSIDIARIES

Notes to the Condensed Consolidated Financial Statements (Unaudited)

Revenue Recognition

Revenue from Government Contracts

Under firm fixed-price milestone contracts, the Company recognizes the firm fixed-price revenue as the milestones are substantially complete and the firm fixed-price for the milestone is earned (“firm fixed-price milestone”). Cash received in advance of the completion of a firm fixed-price milestone will be recorded as deferred revenue until the milestone has been substantially completed and earned.

Under cost reimbursable contracts, the Company recognizes revenue as allowable costs are incurred and the fixed fee is earned (“cost-plus-fixed-fee”). Reimbursable costs under the contract primarily include direct labor, subcontract costs, materials, equipment, travel, and approved overhead and indirect costs. Fixed fees under cost reimbursable contracts are earned in proportion to the allowable costs incurred in performance of the work relative to total estimated contract costs, with such costs incurred representing a reasonable measurement of the proportional performance of the work completed, as detailed in Note 5.

Payments to the Company under cost reimbursable contracts are provisional payments subject to adjustment upon annual audit by the government. The Company believes that revenue for periods not yet audited has been recorded in amounts that are expected to be realized upon final audit and settlement. When the final determination of the allowable costs for any year has been made, revenue and billings  maybe adjusted accordingly in the period that the adjustment is known.

Recent Accounting Pronouncements

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which enhances the annual income tax disclosures for the effective tax rate reconciliation and income taxes paid. ASU 2023-09 is effective for annual reporting periods beginning after December 15, 2024, with early adoption permitted. The Company is currently assessing the impact ASU 2023-09 will have on the consolidated financial statement disclosures.

In November 2024, the FASB issued ASU 2024-03, Income StatementReporting Comprehensive IncomeExpense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires new disclosures to disaggregate prescribed natural expenses underlying any income statement caption. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027, with early adoption permitted. The Company is currently assessing the impact ASU 2024-03 will have on the consolidated financial statement disclosures.

In July 2025, the FASB issued ASU 2025-05, Measurement of Credit Losses for Accounts Receivable and Contract Assets, introducing a practical expedient and an accounting policy election for certain entities in estimating expected credit losses for current accounts receivable and current contract assets arising from transactions within the scope of ASC 606, Revenue from Contracts with Customers. Under the practical expedient, entities may assume that current conditions as of the balance sheet date remain unchanged for the remaining life of the asset when developing forecasts. ASU 2025-05 is effective for the Company beginning in the first quarter of 2026, with early adoption permitted, and should be applied prospectively. The Company is currently assessing the impact of the new guidance on its consolidated financial statement disclosures; however, no material effect is expected based on the current nature of the Company’s receivables and contract assets.

NOTE 3 . Fair Value of Financial Instruments ****

Fair value accounting is applied for all financial assets and liabilities and nonfinancial assets and liabilities that are recognized or disclosed at fair value in the condensed consolidated financial statements on a recurring basis (at least annually). Financial instruments include cash and cash equivalents, marketable securities, accounts receivable, accounts payable and accrued liabilities that approximate fair value due to their relatively short maturities.

Assets and liabilities recorded at fair value on a recurring basis in the condensed consolidated balance sheets are categorized based upon the level of judgment associated with inputs used to measure their fair values. The accounting guidance for fair value provides a framework for measuring fair value and requires certain disclosures about how fair value is determined. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance also establishes a three-level valuation hierarchy that prioritizes the inputs to valuation techniques used to measure fair value based upon whether such inputs are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions made by the reporting entity.

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VAXART , INC. AND SUBSIDIARIES

Notes to the Condensed Consolidated Financial Statements (Unaudited)

The three-level hierarchy for the inputs to valuation techniques is briefly summarized as follows:

Level 1 – Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date;

Level 2 – Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and

Level 3 – Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data.

The following table sets forth the fair value of the Company’s financial assets that are measured on a recurring basis as of  September 30, 2025 and  December 31, 2024 (in thousands):

Level 1 Level 2 Level 3 Total
September 30, 2025
Financial assets:
Money market funds $ 5,727 $ $ $ 5,727
U.S. Treasury securities 16,892 16,892
Commercial paper 2,653 2,653
Total assets $ 5,727 $ 19,545 $ $ 25,272
Level 1 Level 2 Level 3 Total
--- --- --- --- --- --- --- --- ---
December 31, 2024
Financial assets:
Money market funds $ 16,489 $ $ $ 16,489
U.S. Treasury securities 23,805 23,805
Commercial paper 2,689 2,689
Total assets $ 16,489 $ 26,494 $ $ 42,983

The Company held no financial liabilities measured on a recurring basis as of  September 30, 2025 or December 31, 2024.

NOTE 4 . Balance Sheet Components

(a) Cash, Cash Equivalents a nd Short-Term Investments

Cash, cash equivalents and investments consisted of the following (in thousands):

Amortized Gross Unrealized Estimated Cash and Cash Short-Term
Cost Gains Losses Fair Value Equivalents Investments
September 30, 2025 ****
Cash at banks $ 3,521 $ $ $ 3,521 $ 3,521 $
Money market funds 5,727 5,727 5,727
U.S. Treasury securities 16,894 (2 ) 16,892 4,979 11,913
Commercial paper 2,653 2,653 2,653
Total $ 28,795 $ $ (2 ) $ 28,793 $ 16,880 $ 11,913

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VAXART , INC. AND SUBSIDIARIES

Notes to the Condensed Consolidated Financial Statements (Unaudited)

Amortized Gross Unrealized Estimated Cash and Cash Short-Term
Cost Gains Losses Fair Value Equivalents Investments
December 31, 2024 ****
Cash at banks $ 8,740 $ $ $ 8,740 $ 8,740 $
Money market funds 16,489 16,489 16,489
U.S. Treasury securities 23,802 7 (4 ) 23,805 23,805
Commercial paper 2,688 1 2,689 2,689
Total $ 51,719 $ 8 $ (4 ) $ 51,723 $ 25,229 $ 26,494

As of September 30, 2025 and December 31, 2024, all investments were available-for-sale debt securities with remaining maturities of 12 months or less. As of  September 30, 2025 and  December 31, 2024, the Company held 9 and 5 securities, respectively, in an unrealized loss position for 12 months or less. Interest receivable as of September 30, 2025 and December 31, 2024, was $0.1 million and $0.2 million, respectively, and is recorded as a component of prepaid expenses and other current assets on the condensed consolidated balance sheets.

At each reporting date, the Company performs an evaluation of impairment to determine if any unrealized losses are due to credit-related factors. The Company records an allowance for credit losses when unrealized losses are due to credit-related factors. Factors considered when evaluating available-for-sale investments for impairment include the severity of the impairment, changes in underlying credit ratings, the financial condition of the issuer, the probability that the scheduled cash payments will continue to be made and the Company’s intent and ability to hold the investment until recovery of the amortized cost basis. The Company has the ability, if necessary, to liquidate any of its cash equivalents and marketable securities to meet its liquidity needs.

As of  September 30, 2025 and December 31, 2024, there were no material declines in the market value of the Company’s available-for-sale investments due to credit-related factors. The Company does not intend to sell the 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. As of  September 30, 2025 and *December 31, 2024,*no allowance for credit losses was recorded and the Company did not recognize any impairment losses related to investments.

(b) Accounts Receivable

As of September 30, 2025, accounts receivable consists of $42.7 million government contract receivable from 2024 ATI-RRPV Contract. As of  December 31, 2024, accounts receivable balance of $5.7 million consisted of $2.7 million of government contract receivables from HHS BARDA and $3.0 million royalty receivable. See Note 5.

The Company has provided no allowance for credit losses as of  September 30, 2025 and December 31, 2024 based on historical collection experience, customer credit worthiness, the age of accounts receivable balances, regulatory changes and current economic conditions and trends that  mayaffect a customer’s ability to pay.

(c) Unbilled Receivable from Government Contracts

Unbilled receivable, which was earned and not yet billed, consists of government contracts from HHS BARDA of $43.2 million and $6.2 million as of September 30, 2025 and December 31, 2024, respectively, as detailed in Note 5.


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VAXART , INC. AND SUBSIDIARIES

Notes to the Condensed Consolidated Financial Statements (Unaudited)

(d) Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following (in thousands):

September 30, 2025 December 31, 2024
Prepaid clinical and manufacturing expenses $ 750 $ 1,998
Prepaid insurance 394 282
Prepaid rent 539 521
Other prepaid 861 1,449
Other current assets 88 318
Prepaid expenses and other current assets $ 2,632 $ 4,568

As of September 30, 2025 there was a significant concentration by one contract research organization (“CRO”), which represented 24% of the Company’s total prepaid expenses balance. As of  December 31, 2024, there was a significant concentration by one CRO, which represented 28% of the Company’s total prepaid expenses balance.

(e) Property and Equipment, Net

Property and equipment, net consists of the following (in thousands):

September 30, 2025 December 31, 2024
Laboratory equipment $ 13,897 $ 13,806
Office and computer equipment 1,142 1,140
Leasehold improvements 4,000 4,107
Construction in progress 11 160
Total property and equipment 19,050 19,213
Less: accumulated depreciation (12,986 ) (10,508 )
Property and equipment, net $ 6,064 $ 8,705

Depreciation expense was $0.9 million and $1.0 million for the three months ended  September 30, 2025 and 2024, respectively, and $2.7 million and $2.8 million, respectively, for the nine months ended September 30, 2025 and 2024. There were no impairments of the Company’s property and equipment recorded in the three and nine months ended September 30, 2025 and 2024.

(f) Prepaid Clinical Services, Long-Term

Prepaid clinical services, long-term was $60.1 million as of September 30, 2025 and  December 31, 2024. The long-term prepaid clinical services represent amounts the Company has paid to a single CRO that will be utilized beyond one year.

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VAXART , INC. AND SUBSIDIARIES

Notes to the Condensed Consolidated Financial Statements (Unaudited)

(g) Right-of-Use Assets , Net

Right-of-use assets, net comprises facilities of $17.1 million and $20.4 million as of September 30, 2025 and December 31, 2024, respectively.

(h) Intangible Assets, Net

Intangible assets are comprised of developed technology and intellectual property. Intangible assets are carried at cost less accumulated amortization. As of September 30, 2025, developed technology and intellectual property had remaining lives of 4.1 years and 2.3 years, respectively. As of September 30, 2025, there have been no indicators of impairment.

Intangible assets consist of the following (in thousands):

September 30, 2025 December 31, 2024
Developed technology $ 5,000 $ 5,000
Intellectual property 80 80
Total cost 5,080 5,080
Less: accumulated amortization (2,071 ) (1,523 )
Intangible assets, net $ 3,009 $ 3,557

Intangible asset amortization expense was $0.1 million for each of the three months ended September 30, 2025 and 2024, and $0.5 million for each of the nine months ended September 30, 2025 and 2024.

As of September 30, 2025, the estimated future amortization expense by year is as follows (in thousands):

Year Ending December 31, Amount
2025 (three months remaining) $ 184
2026 731
2027 731
2028 727
2029 636
Total $ 3,009
(i) Goodwill
--- ---

Goodwill, which represents the excess of the purchase price over the fair value of assets acquired, was $4.5 million as of  September 30, 2025 and December 31, 2024. As of September 30, 2025, there have been no indicators of impairment.

(j) Accounts Payable

Accounts payable were $53.1 million and $7.0 million as of September 30, 2025 and December 31, 2024, respectively. As of September 30, 2025, there was a significant concentration by one CRO, which represented 86% of the Company’s total accounts payable balance. As of  December 31, 2024, there was a significant concentration by one CRO, which represented 67% of the Company’s total accounts payable balance.

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VAXART , INC. AND SUBSIDIARIES

Notes to the Condensed Consolidated Financial Statements (Unaudited)

(k) Deferred Government Revenue

Deferred government revenue represents amounts received from HHS BARDA contracts where the earnings process is not yet complete. The Company will recognize deferred government revenue once the earnings process is complete, in accordance with its revenue recognition policies.

The following table represents the Company’s deferred government revenue during the nine months ended September 30, 2025 (in thousands):

September 30, 2025
Balance at December 31, 2024 $ 65,400
Revenue recognized (753 )
Amounts collected or invoiced 181
Balance at September 30, 2025 $ 64,828

The Company recognized $0.7 million and zero revenue during the three months ended  September 30, 2025 and 2024, respectively, and $0.8 million and zero revenue during the nine months ended September 30, 2025 and 2024, respectively. Amounts collected or invoiced during the nine months ended September 30, 2025, primarily relate to amounts received on the 2024 ATI-RRPV Contract (as defined in Note 5), but for which revenue cannot yet be recognized due to contractual milestones not being achieved.

(l) Other Accrued Current Liabilities

Other accrued current liabilities consist of the following (in thousands):

September 30, 2025 December 31, 2024
Accrued compensation $ 3,643 $ 5,087
Accrued clinical and manufacturing expenses 40,216 5,134
Accrued professional and consulting services 561 623
Other liabilities, current portion 462 534
Total $ 44,882 $ 11,378

As of September 30, 2025 and December 31, 2024, there was a significant concentration by one CRO, which represented 80% and 42% of the Company’s total other accrued liabilities balances, respectively.

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VAXART , INC. AND SUBSIDIARIES

Notes to the Condensed Consolidated Financial Statements (Unaudited)

NOTE 5 . Revenue

Royalty Revenue Related to Sale of Future Royalties

The Company generates royalty revenue from the sale of Inavir in Japan, pursuant to a collaboration and license agreement that Aviragen entered into with Daiichi Sankyo Company, Limited (“Daiichi Sankyo”) in 2009. In September 2010, laninamivir octanoate was approved for sale by the Japanese Ministry of Health and Welfare for the treatment of influenza in adults and children, which Daiichi Sankyo markets as Inavir. Under the agreement, the Company currently receives a 4% royalty on net sales of Inavir in Japan. Based on information provided by Daiichi Sankyo, the Company believes the expiration of the last patent related to Inavir is in  August 2036, at which time royalty revenue will cease. The Company’s royalty revenue is seasonal, in line with the flu season, so the majority of the Company’s royalty revenue and non-cash royalty revenue related to the sale of future royalties are earned in the first and fourth fiscal quarters. The royalty revenue related to Inavir recognized for the three and nine months ended September 30, 2025 and 2024 was zero. The non-cash royalty revenue related to the sale of future royalties was zero and $40,000 for the three months ended September 30, 2025 and 2024, respectively, and $1.6 million and $0.7 million for the nine months ended September 30, 2025 and 2024, respectively. Both royalty revenue and the non-cash royalty revenue related to the sale of future royalties are subject to a 5% withholding tax in Japan, for which zero and $2,000 was included in income tax expense for the three months ended September 30, 2025 and 2024, respectively, and $79,000 and $33,000 for the nine months ended September 30, 2025 and 2024, respectively, further detailed in Note 6.

Revenue from Government Contracts

The Company recognized revenue from government contracts with HHS BARDA of $72.4 million and $4.9 million for the three months ended September 30, 2025 and 2024, respectively, and $131.4 million and $12.9 million for the nine months ended September 30, 2025 and 2024, respectively, consisting of revenue from the 2024 ASPR-BARDA Contract (as defined below) and the 2024 ATI-RRPV Contract (as defined below) described in more detail below. Unbilled receivable from government contracts consists of government revenue from HHS BARDA, which was earned and not yet billed. As of September 30, 2025 and December 31, 2024, the amount of unbilled receivable was $43.2 million and $6.2 million, respectively, and deferred revenue was $64.8 million and $65.4 million, respectively.

2024 ATI-RRPV Contract (See Note 12)

In June 2024, the Company entered into an agreement (as modified or amended from time to time the “2024 ATI-RRPV Contract”) with Advanced Technology International (“ATI”), the Rapid Response Partnership Vehicle’s Consortium Management Firm funded by HHS BARDA, which was modified in the first quarter of 2025 to increase funding and provide for the manufacturing of a vaccine candidate targeting the KP.2 strain and acquire an approved mRNA vaccine targeting the KP.2 strain. Pursuant to the 2024 ATI-RRPV Contract, the Company was to receive funding of up to $460.7 million to conduct a Phase 2b comparative study evaluating the Company’s oral pill COVID-19 vaccine candidate against an mRNA vaccine comparator approved by the U.S. Food and Drug Administration (“FDA”). The 2024 ATI-RRPV Contract makes available an aggregate amount of up to $305.0 million, consisting of firm fixed price amounts totaling $67.9 million and reimbursement of costs incurred in trial preparation and execution activities. The 2024 ATI-RRPV Contract further contemplates additional funding up to $155.7 million if the Company and HHS BARDA decide to continue with the Phase 2b comparative study. This additional funding under the 2024 ATI-RRPV Contract is currently under review in light of the August 2025 stop work order and is likely to be reduced in line with the reduced enrollment of approximately 5,000 participants versus the original planned enrollment of 10,000 participants in the main cohort of the Phase 2b study.

The Company accounts for the 2024 ATI-RRPV Contract under Accounting Standards Codification 958-605 (“ASC 958-605”) and recognizes revenue as the firm fixed-price milestone is earned and allowable cost-plus-fixed-fees are incurred. Reimbursable costs under the 2024 ATI-RRPV Contract primarily include direct labor, subcontract costs, materials, travel, and approved overhead and indirect costs. The 2024 ATI-RRPV Contract contains terms and conditions that are customary for contracts with HHS BARDA of this nature, including the U.S. government having the right to terminate the contract for convenience or to terminate for default if the Company fails to meet its obligations as set forth in the statement of work. Revenue from government contracts recognized on the 2024 ATI-RRPV Contract was $71.8 million, comprised entirely of the cost-plus-fixed-fee, for the three months ended September 30, 2025, and $130.8 million, comprising of a cost-plus-fixed-fee of $130.0 million and a firm fixed-price milestone of  $0.8 million, for the nine months ended September 30, 2025, based on costs incurred and the achievement of firm fixed-price milestones under the 2024 ATI-RRPV Contract. Revenue from government contracts recognized on the 2024 ATI-RRPV Contract was $4.0 million for the three months ended September 30, 2024, and $4.2 million for the nine months ended September 30, 2024, based on costs incurred and the achievement of a firm fixed-price milestone under the 2024 ATI-RRPV Contract. Deferred government revenue represents amounts that have been received from HHS BARDA and the earnings process is not yet complete. Deferred government revenue in current liabilities was $64.8 million as of September 30, 2025 and December 31, 2024, respectively. The remaining deferred government revenue as of September 30, 2025, will be recognized as revenue once the earnings process is complete.

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VAXART , INC. AND SUBSIDIARIES

Notes to the Condensed Consolidated Financial Statements (Unaudited)

The Company believes that if the 2024 ATI-RRPV Contract were to be terminated prior to completion of the Phase 2b comparative study, the costs incurred through the effective date of such termination and any settlement costs resulting from such termination would be allowable costs. Cost reimbursement payments to the Company are provisional payments subject to adjustment upon annual audit by the government. The Company believes that revenue for periods not yet audited will be recorded in amounts that are expected to be realized upon final audit and settlement. When the final determination of the allowable costs for any year has been made, revenue and billings may be adjusted accordingly in the period that the adjustment becomes known.

2024 ASPR-BARDA Contract

In January 2024, the Company was awarded a contract (as modified or amended, the “2024 ASPR-BARDA Contract”) by HHS BARDA with a base and all options value of $9.3 million. Under the 2024 ASPR-BARDA Contract, the Company received an award to support clinical trial planning activities for a Phase 2b clinical trial that would compare the Company’s XBB vaccine candidate to an mRNA comparator to evaluate efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and adverse events. The 2024 ASPR-BARDA Contract originally had a period of performance term that was set to expire in July 2024, but the Company entered into an amendment in July 2024 that extended the period of performance expiration date into October 2024. The Company accounts for the 2024 ASPR-BARDA Contract under ASC 958-605 and recognizes revenue as donor-imposed conditions are met. Revenue from government contracts recognized on the 2024 ASPR-BARDA Contract was $0.6 million and $0.9 million for the three months ended September 30, 2025 and 2024, respectively, and $0.6 million and $8.7 million for the nine months ended September 30, 2025 and 2024, respectively. Deferred government revenue represents amounts that have been received from HHS BARDA and the earnings process is not yet complete. Deferred government revenue in current liabilities was zero and $0.6 million as of September 30, 2025 and December 31, 2024, respectively.

NOTE 6 . **** Liabilities Related to Sale of Future Royalties

In April 2016, Aviragen entered into a Royalty Interest Acquisition Agreement (the “RIAA”) with HealthCare Royalty Partners III, L.P. (“HCRP”). Under the RIAA, HCRP made a $20.0 million cash payment to Aviragen in consideration for acquiring certain royalty rights (“Royalty Rights”) related to the approved product Inavir in the Japanese market. The Royalty Rights were obtained pursuant to the collaboration and license agreements (the “License Agreement”) and a commercialization agreement that the Company entered into with Daiichi Sankyo. Per the terms of the RIAA, during the first royalty interest period of April 1, 2016through March 31, 2025, HCRP is entitled to the first $3.0 million and any cumulative remaining shortfall amount plus 15% of the next $1.0 million in royalties earned in each year commencing on April 1, with any excess revenue being retained by the Company. Further, during the second royalty interest period beginning April 1, 2025 and ending on December 24, 2029, HCRP is entitled to the first $2.7 million and any cumulative remaining shortfall amount, plus 15% of the next $1.0 million in royalties, with any excess revenue being retained by the Company. A shortfall occurs when, during an annual period ending on  March 31^st^, for the first royalty interest period of April 1, 2016 through March 31, 2025, the Company’s royalty payments fall below $3.0 million; and $2.7 million for the second royalty interest period of April 1, 2025 and ending on December 24, 2029, excluding the period of April 1, 2028 through December 24, 2029. In the event there shall remain any cumulative remaining shortfall amount as of December 24, 2029, any royalties received from Daiichi Sankyo subsequently by the Company would be payable to HCRP until the cumulative remaining shortfall amount has been paid.

For avoidance of doubt, the RIAA states, in the event there is a remaining cumulative remaining shortfall amount as of December 24, 2029, the Company shall not be obligated to pay HCRP any royalty payment beyond what the Company is paid from Daiichi Sankyo. The cumulative remaining shortfall amount is the aggregate amount of the remaining shortfall for each annual period, which was $4.4 million and $6.0 million as of September 30, 2025 and December 31, 2024, respectively.

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VAXART , INC. AND SUBSIDIARIES

Notes to the Condensed Consolidated Financial Statements (Unaudited)

Under the relevant accounting guidance, due to a limit on the amount of royalties that HCRP can earn under the RIAA, this transaction was accounted for as a liability that is being amortized using the effective interest method over the life of the arrangement. The Company has no obligation to pay any amounts to HCRP other than to pass through to HCRP its share of royalties as they are received from Daiichi Sankyo. To record the amortization of the liability, the Company is required to estimate the total amount of future royalty payments to be received under the License Agreement and the payments that will be passed through to HCRP over the life of this agreement. Consequently, the Company imputes interest on the unamortized portion of the liability and records non-cash interest expense using an estimated effective interest rate. The royalties earned in each period that will be passed through to HCRP are recorded as non-cash royalty revenue related to sale of future royalties, with any excess not subject to pass-through being recorded as royalty revenue. When the pass-through royalties are paid to HCRP in the following quarter, the imputed liability related to sale of future royalties is commensurately reduced. The Company periodically assesses the expected royalty payments, and to the extent such payments are greater or less than the initial estimate, the Company adjusts the amortization of the liability and interest rate. As a result of this accounting, even though the Company does not retain HCRP’s share of the royalties, it will continue to record non-cash revenue related to those royalties until the amount of the associated liability, including the related interest, is fully amortized.

The following table shows the activity within the liability account during the nine months ended September 30, 2025 (in thousands):

Total liability related to sale of future royalties, start of period $ 5,758
Non-cash royalty revenue paid to HCRP (4,521 )
Non-cash interest expense recognized 2,277
Total liability related to sale of future royalties, end of period 3,514
Current portion (2,732 )
Long-term portion $ 782

NOTE 7 .  Commitments and Contingencies

(a) Purchase Commitments

As of September 30, 2025, the Company had approximately $24.5 million of non-cancelable purchase commitments, principally for clinical services which are expected to be paid within the next year. Approximately $23.4 million of non-cancelable purchase commitments are attributable to a third-party vendor that provides clinical services, that is reimbursable at approximately $25.2 million under a cost-plus-fixed-fees arrangement in the ATI-RRPV Contract.

(b) Indemnifications

In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend indemnified parties for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. The Company has also entered into indemnification agreements with certain officers and directors which provide, among other things, that the Company will indemnify and advance expenses incurred in connection with certain actions, suits or proceedings to such officer or director, under the circumstances and to the extent provided for therein, for expenses, damages, judgments, fines and settlements he or she may be required to pay in actions or proceedings which he or she is or may be made a party by reason of his or her position as a director, officer or other agent of the Company, and otherwise to the fullest extent permitted under Delaware law and the Company’s Bylaws. The Company currently has directors’ and officers’ insurance.

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Notes to the Condensed Consolidated Financial Statements (Unaudited)

(c) Litigation

From time to time the Company may be involved in legal proceedings arising in connection with its business. Based on information currently available, the Company believes that the amount, or range, of reasonably possible losses in connection with any pending actions against it in excess of established reserves, in the aggregate, is indeterminable to its consolidated financial condition or cash flows. However, any current or future dispute resolution or legal proceeding, regardless of the merits of any such proceeding, could result in substantial costs and a diversion of management’s attention and resources that are needed to run the Company successfully, and could have a material adverse impact on its business, financial condition and results of operations.

In August and September 2020, two substantially similar securities class actions were filed in the U.S. District Court for the Northern District of California. The first action, titled Himmelberg v. Vaxart, Inc. et al. was filed on August 24, 2020. The second action, titled Hovhannisyan v. Vaxart, Inc. et al. was filed on *September 1, 2020 (*together, the “Putative Class Action”). By Order dated September 17, 2020, the two actions were deemed related. On December 9, 2020, the court appointed lead plaintiffs and lead plaintiffs’ counsel.

On January 29, 2021, lead plaintiffs filed their consolidated amended complaint. On May 14, 2021, the court granted lead plaintiffs’ request to amend the consolidated amended complaint and denied defendants’ motions to dismiss as moot. On June 10, 2021, lead plaintiffs filed a first amended consolidated complaint, and on August 9, 2021, lead plaintiffs filed a corrected first amended consolidated complaint. The first amended consolidated complaint, as corrected, named certain of Vaxart’s current and former executive officers and directors, as well as Armistice Capital, LLC (“Armistice”), as defendants. It claimed three violations of federal civil securities laws; violation of Section 10(b) of the Exchange Act and SEC Rule 10b-5, as against the Company and all individual defendants; violation of Section 20(a) of the Exchange Act, as against Armistice and all individual defendants; and violation of Section 20A of the Exchange Act against Armistice. The first amended consolidated complaint, as corrected, alleged that the defendants violated securities laws by misstating and/or omitting information regarding the Company’s development of a norovirus vaccine, the vaccine manufacturing capabilities of a business counterparty, and the Company’s involvement with Operation Warp Speed (“OWS”); and by engaging in a scheme to inflate Vaxart’s stock price. The first amended consolidated complaint sought certification as a class action for similarly situated shareholders and sought, among other things, an unspecified amount of damages and attorneys’ fees and costs. On July 8, 2021, all defendants moved to dismiss the first amended consolidated complaint. By Order dated December 22, 2021, the court granted the motion to dismiss by Armistice with leave to amend and otherwise denied the motions to dismiss. On July 27, 2022, lead plaintiffs filed a notice announcing that they had reached a partial settlement (the “Partial Settlement”) to resolve all claims against the Company and its current or former officers and/or directors in their capacity as officers and/or directors of the Company (the “Settling Defendants”). Pursuant to the Partial Settlement, the Company agreed to a settlement amount of $12.0 million with $2.0 million to be paid by the Company and the remainder to be paid by the Company’s insurers. On November 2, 2022, the Company paid the $2.0 million settlement amount with respect to the Putative Class Action pursuant to the terms of the settlement agreement reached in that case. On November 14, 2022, lead plaintiffs filed a second amended consolidated class action complaint that purported to include new allegations to support claims against Armistice. By Orders dated January 25, 2023, the court approved the Partial Settlement and entered judgment dismissing with prejudice all claims asserted in the Putative Class Action against the Settling Defendants.

On October 23, 2020, a complaint was filed in the U.S. District Court for the Southern District of New York, entitled Roth v. Armistice Capital LLC, et al. The complaint names Armistice and certain Armistice-related parties as defendants, asserting a violation of Exchange Act Section 16(b) and seeking the disgorgement of short-swing profits. The complaint purports to bring the lawsuit on behalf of and for the benefit of the Company and names the Company as a “nominal defendant” for whose benefit damages are sought. Following discovery, a motion for summary judgment was filed by Armistice and the Armistice-related party defendants to dismiss the complaint. On March 27, 2024, the court granted the motion for summary judgment and dismissed all claims in the complaint in their entirety. On April 11, 2024, the Plaintiff timely filed a notice of appeal of the court’s decision to the Second Circuit Court of Appeals, commencing appellate proceedings. In June 2024, Plaintiff filed a motion to the court of appeals to stay the appeal pending efforts to re-instate the complaint in the district court, which was granted by the court of appeals.  In July 2024, Plaintiff filed a motion with the district court seeking to set aside the judgment and to re-instate the complaint. On August 15, 2024, the district court denied Plaintiff’s motion to set aside the judgment. On September 10, 2024, Plaintiff re-filed its appeal with the Second Circuit Court of Appeals, which is currently pending.

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Notes to the Condensed Consolidated Financial Statements (Unaudited)

On January 8, 2021, a purported shareholder, Phillip Chan, commenced a pro se lawsuit in the U.S. District Court for the Northern District of California titled Chan v. Vaxart, Inc. et al. (the “Opt-Out Action”), opting out of the consolidated Himmelberg v. Vaxart, Inc. et al. and Hovhannisyan v. Vaxart, Inc. et al. class actions, (together, the “Putative Class Action”). Because this complaint is nearly identical to an earlier version of a complaint filed in the Putative Class Action, the Opt-Out Action has been stayed while the Putative Class Action is pending.

NOTE 8.  Stock holders’ Equity


(a) P referred Stock

The Company is authorized to issue 5,000,000 shares of preferred stock, $0.0001 par value per share. The Company’s board of directors may, without further action by the stockholders, fix the rights, preferences, privileges and restrictions of up to an aggregate of 5,000,000 shares of preferred stock in one or more series and authorize their issuance. These rights, preferences and privileges could include dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting any series or the designation of such series, any or all of which may be greater than the rights of the Company's common stock. The issuance of preferred stock could adversely affect the voting power of holders of common stock and the likelihood that such holders will receive dividend payments and payments upon liquidation. In addition, the issuance of preferred stock could have the effect of delaying, deterring or preventing a change of control or other corporate action. No shares of preferred stock are currently outstanding, and the Company has no present plan to issue any shares of preferred stock.

(b) Common Stock

As of September 30, 2025, the Company was authorized to issue 350,000,000 shares of common stock, $0.0001 par value per share. Except as otherwise required by law or as otherwise provided in any certificate of designation for any series of preferred stock, the holders of common stock possess all voting power for the election of the Company’s directors and all other matters requiring stockholder action. Holders of common stock are entitled to one vote per share on matters to be voted on by stockholders. Holders of common stock are entitled to receive such dividends, if any, as may be declared from time to time by the Company’s board of directors in its discretion out of funds legally available therefor. In no event will any stock dividends or stock splits or combinations of stock be declared or made on common stock unless the shares of common stock at the time outstanding are treated equally and identically. As of September 30, 2025, no dividends had been declared by the board of directors.

In March 2025, the Company entered into the March 2025 ATM with Citizens and B. Riley, pursuant to which the Company may offer and sell, from time to time through the Managers, shares of its common stock having an aggregate offering price of up to $50 million. The shares will be sold pursuant to the 2023 Shelf Registration Statement. The Company filed a prospectus supplement, dated March 21, 2025, with the SEC in connection with the offer and sale of the shares under the March 2025 ATM. The Company will pay the Managers a placement fee of up to 3% of the gross sale price from each sale of the shares under the March 2025 ATM. During the three and nine months ended September 30, 2025, 382,700 shares were issued and sold under the March 2025ATM for gross proceeds of $0.2 million, which, after deducting sales commissions and expenses incurred to date, resulted in net proceeds of $0.1 million.

In June 2024, the Company entered into an underwriting agreement with Oppenheimer & Co. Inc., relating to the issuance and sale by the Company in an underwritten registered direct offering of 50,000,000 shares of the Company’s common stock, at a price of $0.80 per share. The gross proceeds to the Company from such offering were $40.0 million, and after deducting the underwriting discounts and commissions and estimated offering expenses payable by the Company, the net proceeds were $37.5 million.

In January 2024, the Company entered into the 2024 Securities Purchase Agreement with RA Capital Healthcare Fund, L.P. pursuant to which 15,384,615 shares of the Company's common stock were sold to RA Capital Healthcare Fund, L.P. at an offering price of $0.65 per share pursuant to the Company’s 2023 Shelf Registration Statement. The gross proceeds from the 2024 Securities Purchase Agreement were $10.0 million and, after deducting offering expenses, the net proceeds were $9.9 million.

In the event of the Company’s voluntary or involuntary liquidation, dissolution, distribution of assets or winding-up, the holders of the common stock will be entitled to receive an equal amount per share of all the Company’s assets of whatever kind available for distribution to stockholders, after the rights of the holders of the preferred stock have been satisfied. There are no sinking fund provisions applicable to the common stock.

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VAXART , INC. AND SUBSIDIARIES

Notes to the Condensed Consolidated Financial Statements (Unaudited)

The Company had shares of common stock reserved for issuance as follows:

September 30, 2025 December 31, 2024
Stock options issued and outstanding 25,668,404 20,405,239
RSUs, issued and outstanding 5,779,522 3,016,481
2019 Equity Incentive Plan common stock available for future issuance 10,684,202 18,046,374
2024 Inducement Award Plan common stock available for future issuance 43,250 1,603,750
Common stock warrants, issued and outstanding 10,914 140,596
2022 Employee Stock Purchase Plan common stock available for future issuance 2,147,316 2,362,902
Total common stock reserved 44,333,608 45,575,342
(c) Warrants
--- ---

The following warrants were outstanding as of September 30, 2025, all of which contain standard anti-dilution protections in the event of subsequent rights offerings, stock splits, stock dividends or other extraordinary dividends, or other similar changes in the Company’s common stock or capital structure, and none of which have any participating rights for any losses:

Securities into which warrants are convertible Warrants Outstanding Exercise Price Expiration Date
Common Stock 10,914 $ 22.99 December 2026

NOTE 9. Equity Incentive Plan s

The Company has maintained the 2019 Equity Incentive Plan and the 2024 Inducement Award Plan for the issuance of stock options, stock appreciation rights, restricted stock awards, restricted stock units (“RSUs”), other stock awards and performance awards that may be settled in cash, stock, or other property to employees, directors and consultants. The terms of the 2024 Inducement Award Plan are substantially similar to the terms of the 2019 Equity Incentive Plan, with the exception that incentive stock options may not be issued under the 2024 Inducement Plan and equity awards under the 2024 Inducement Plan (including nonqualified stock options, restricted stock, restricted stock units, and other stock-based awards) may be issued only to an employee who is commencing employment with the Company or any subsidiary or who is being rehired following a bona fide interruption of employment by the Company or any subsidiary, in either case if he or she is granted such award in connection with his or her commencement of employment and such grant is an inducement material to his or her entering into employment with the Company or such subsidiary. The Company also maintains the 2022 Employee Stock Purchase Plan (“ESPP”) for its employees.

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Notes to the Condensed Consolidated Financial Statements (Unaudited)

A summary of stock option and RSU transactions during the nine months ended September 30, 2025, is as follows:

**** **** Weighted **** Weighted
Shares Number of Option Average Unvested RSU Average
Available Options Exercise RSU Shares Grant Date
For Grant Outstanding Price Outstanding Fair Value
Balance as of January 1, 2025 19,650,124 20,405,239 $ 2.49 3,016,481 $ 1.19
Granted (12,758,895 ) 8,258,792 $ 0.53 4,500,103 $ 0.52
Exercised (3,625 ) $ 0.78 $
Released $ (881,760 ) $ 1.26
Forfeited 2,596,182 (1,740,880 ) $ 0.94 (855,302 ) $ 0.81
Canceled 1,240,041 (1,251,122 ) $ 2.34 $
Balance as of September 30, 2025 10,727,452 25,668,404 $ 1.97 5,779,522 $ 0.71

As of September 30, 2025, there were 25,668,404 options outstanding with a weighted average exercise price of $1.97, a weighted average remaining term of 7.52 years, and an aggregate intrinsic value of $5,000. Of these options, 14,383,244 were vested, with a weighted average exercise price of $2.88, a weighted average remaining term of 6.35 years, and an aggregate intrinsic value of $5,000.

The Company received $3,000 for the 3,625 options exercised during the nine months ended September 30, 2025, which had a minimal intrinsic value. The Company received $30,000 for the 38,030 options exercised during the nine months ended September 30, 2024, which had an intrinsic value of $7,000. The aggregate intrinsic value represents the total pre-tax value (i.e., the difference between the Company’s stock price and the exercise price) of stock options outstanding as of September 30, 2025 and 2024, respectively, based on the Company’s common stock closing price of $0.36 on September 30, 2025 and $0.85 on September 30, 2024, which would have been received by the option holders had all their in-the-money options been exercised as of that date.

The weighted average grant date fair value of options awarded in the nine months ended September 30, 2025 and 2024, was $0.47 and $1.01, respectively. Their fair values were estimated using the following assumptions:

Nine Months Ended September 30,
2025 2024
Risk-free interest rate 4.1% - 4.4% 3.7% - 4.4%
Expected term (in years) 5.5 - 6.0 6.0
Expected volatility 125.8% - 128.6% 128.9% - 130.8%
Dividend yield % %

The Company measures the fair value of all stock-based awards on the grant date and records the fair value of these awards, net of estimated forfeitures, to compensation expense over the service period. Total stock-based compensation recognized for options, RSUs and ESPP was as follows (in thousands):

Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
Research and development $ 1,329 $ 1,814 $ 4,525 $ 5,489
General and administrative 689 661 2,073 3,657
Total stock-based compensation $ 2,018 $ 2,475 $ 6,598 $ 9,146

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VAXART , INC. AND SUBSIDIARIES

Notes to the Condensed Consolidated Financial Statements (Unaudited)

As of September 30, 2025, the unrecognized stock-based compensation cost related to outstanding unvested stock options and RSUs expected to vest was $11.0 million, which the Company expects to recognize over an estimated weighted average period of 2.5 years.

NOTE 10 .  Net Loss **** Per Share Attributable to Common Stockholders

The following table presents the calculation of basic and diluted net loss per share (in thousands, except share and per share amounts):

Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
Net loss $ (8,141 ) $ (14,080 ) $ (38,718 ) $ (54,963 )
Shares used to compute net loss per share – basic and diluted 228,926,340 227,452,883 228,405,929 193,655,660
Net loss per share – basic and diluted $ (0.04 ) $ (0.06 ) $ (0.17 ) $ (0.28 )

No adjustment has been made to the net loss in the three and nine months ended September 30, 2025 and 2024, as the effect would be anti-dilutive due to the net loss.

The following potentially dilutive weighted average securities were excluded from the computation of weighted average shares outstanding because they would have been antidilutive:

Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
Options to purchase common stock 26,231,501 21,568,098 24,698,785 19,869,813
Restricted stock units to purchase common stock 5,854,854 3,090,220 5,025,022 2,600,499
Warrants to purchase common stock 10,914 140,596 10,914 175,928
Employee Stock Purchase Plan 415,948 368,002 437,533 235,819
Total potentially dilutive securities excluded from denominator of the diluted earnings per share computation 32,513,217 25,166,916 30,172,254 22,882,059

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Notes to the Condensed Consolidated Financial Statements (Unaudited)

NOTE 11. Segment Reporting

The Company operates in one reportable segment, which is the discovery and development of oral recombinant protein vaccines, based on its proprietary oral vaccine platform. The accounting policies of the segment are the same as those described in the summary of significant accounting policies. The determination of a single business segment is consistent with the consolidated financial information regularly reviewed by the Chief Executive Officer as chief operating decision maker (the “CODM”) in assessing segment performance and deciding how to allocate resources on a consolidated basis.

The CODM uses consolidated net loss to evaluate the Company’s spend and monitor budget versus actual results. The monitoring of budgeted versus actual results is used in assessing performance of the segment and in establishing resource allocation across the organization. The measure of segment assets is reported on the consolidated balance sheets as total assets.

The Company's segment revenue, segment loss, significant segment expenses, and other segment items consist of the following (in thousands):

Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
Revenue $ 72,413 $ 4,933 $ 133,019 $ 13,515
Less:
Research and development
External program costs:
Norovirus program 519 821 3,227 2,560
COVID-19 program 66,220 1,513 118,413 7,849
Other programs - 2 346 16
Preclinical research 98 216 722 1,596
Process Development 106 46 189
Internal research and development costs 9,110 12,408 33,672 39,349
General and administrative 4,277 4,342 13,942 16,757
Interest income (302 ) (1,022 ) (1,049 ) (1,941 )
Non-cash interest expense related to sale of future royalties 608 631 2,277 2,045
Other segment items^(A)^ 7 (22 ) 9 (26 )
Provision for income taxes 17 18 132 84
Segment net loss $ (8,141 ) $ (14,080 ) $ (38,718 ) $ (54,963 )
Reconciliation of net loss **** **** **** ****
Adjustments and reconciling items
Net loss $ (8,141 ) $ (14,080 ) $ (38,718 ) $ (54,963 )

(A) Other segment items included in other income (expense), net.

Note 12. Subsequent Events

Stop Work Order Follow-Up Notice Received for the 2024 ATI-RRPV Contract

On October 8, 2025, the Company received written notification (the “Follow-Up Notice”) from ATI. The Follow-Up Notice clarifies the scope of the 2024 ATI-RRPV Contract and BARDA’s intention to conclusively delimit the provisions of the 2024 ATI-RRPV Contract to exclude work that has been subject to the August 5, 2025stop work order.  For details of the August 5, 2025 stop work order, see Note 5.

The Dynavax License Agreement and Securities Purchase Agreement

On November 4, 2025, the Company entered into (i) an Exclusive License and Collaboration Agreement (the “License Agreement”) with Dynavax Technologies Corporation (“Dynavax”) relating to Vaxart’s investigational oral vaccine candidate for COVID-19 based on Vaxart’s oral delivery platform and (ii) a Securities Purchase Agreement (the “Purchase Agreement”) with Dynavax for the sale of the Company’s common stock. Pursuant to the License Agreement, the Company granted Dynavax an exclusive, worldwide license to develop and commercialize the Company’s oral pill COVID-19 vaccine candidate for SARS-CoV-2, SARS coronavirus, or MERS coronavirus, including COVID-19 and all variants of SARS-CoV-2, SARS coronavirus, or MERS coronavirus. In turn, Dynavax has agreed to pay Vaxart an upfront license fee of $25.0 million and to purchase $5.0 million of the shares of the Company’s common stock, pursuant to the terms of the Purchase Agreement. The License Agreement includes a collaboration component to efficiently develop, obtain regulatory approval, and commercialize products for such limited field of use as described in greater detail in the Current Report on Form 8-K filed by the Company with the SEC on November 5, 2025. On the terms and subject to the conditions set forth in the Purchase Agreement, the Company sold and issued 11,111,111 shares of common stock at a per share purchase price of $0.45 pursuant to the shelf registration statement filed by the Company with the SEC on Form S-3, including the prospectus dated May 5, 2025, contained therein, and the prospectus supplement dated *November 4, 2025.*As of the date of the report, the Company has received the upfront license fee and the purchase price for the shares in an aggregate amount of $30.0 million from Dynavax pursuant to the License Agreement and the Purchase Agreement.

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Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations shoul d be read in conjunction with our condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and with our audited consolidated financial statements included in our Annual Report on Form 10-K filed with the SEC on March 20, 2025. This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “goal,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “predict,” “potential” and similar expressions intended to identify forward-looking statements and reflect our beliefs and opinions on the relevant subject. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and in this Quarterly Report on Form 10-Q. The forward-looking statements included in this Quarterly Report on Form 10-Q are made only as of the date hereof. These statements are based upon information available to us as of the filing date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and we caution investors against unduly relying upon these statements. In all events, we undertake no obligation to revise or update any forward-looking statements, whether as a result of new information, change in circumstances, future events or otherwise, and you are advised to consult any additional disclosures that we may make directly to you or through reports that we, in the future, may file with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K.

Company Overview and Background

We are a clinical-stage biotechnology company primarily focused on the development of oral recombinant vaccines based on our Vector-Adjuvant-Antigen Standardized Technology (“VAAST”) proprietary oral vaccine platform. We are developing prophylactic vaccine candidates that target a range of infectious diseases, including norovirus (a widespread cause of acute gastroenteritis), coronavirus including SARS-CoV-2 (the virus that causes coronavirus disease 2019 (“COVID-19”)), and influenza. In addition, we have generated preclinical data for our first therapeutic vaccine candidate targeting cervical cancer and dysplasia caused by human papillomavirus (“HPV”). Our oral vaccines are designed to generate broad and durable immune responses that may protect against a wide range of infectious diseases and may be useful for the treatment of chronic viral infections and cancer. Our investigational vaccines are administered using a room temperature-stable tablet, rather than by injection.

Vaxart Biosciences, Inc. was originally incorporated in California under the name West Coast Biologicals, Inc. in March 2004 and changed its name to Vaxart, Inc. (“Private Vaxart”) in July 2007, when it reincorporated in the state of Delaware. On February 13, 2018, Private Vaxart completed a reverse merger (the “Merger”) with Aviragen Therapeutics, Inc. (“Aviragen”), pursuant to which Private Vaxart survived as a wholly owned subsidiary of Aviragen. Under the terms of the Merger, Aviragen changed its name to Vaxart, Inc. and Private Vaxart changed its name to Vaxart Biosciences, Inc.

Our Product Pipeline

We are developing the following tablet vaccine candidates, which are all based on our proprietary platform:

Norovirus Vaccine***.*** Norovirus is the leading cause of acute gastroenteritis symptoms, such as vomiting and diarrhea, among people of all ages in the United States. Each year, on average in the United States, norovirus causes 19 to 21 million cases of acute gastroenteritis and contributes to 109,000 hospitalizations and 900 deaths, mostly among young children and older adults. Virtually all norovirus disease is caused by norovirus GI and GII genotypes, and we are developing a bivalent vaccine candidate designed to protect against both.

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Adult and Elderly. In September 2023, we announced that our Phase 2 GI.1 norovirus challenge study evaluating the safety, immunogenicity, and clinical efficacy of the GI.1 component of our first-generation bivalent norovirus vaccine candidate met five of six primary endpoints based on preliminary topline data. The study achieved its primary endpoints of a statistically significant 30% relative reduction in the rate of norovirus infection between the vaccinated and placebo arms, a strong induction of norovirus-specific immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies, and other immune response endpoints.

Vaccination also led to a 21% relative reduction in norovirus acute gastroenteritis in the vaccine arm compared to placebo, but this finding did not reach statistical significance. In other prespecified analyses, the study showed an 85% relative decrease in viral shedding in the vaccine arm compared with placebo and no statistically significant difference in disease severity in the vaccinated cohort compared with placebo. The vaccine candidate was safe and well tolerated with no vaccine-related serious adverse events.

Based on our norovirus clinical data findings to date, our norovirus oral vaccination induces mucosal and systemic immune responses. Norovirus oral vaccination reduced infection and viral shedding in a rigorous human challenge model. Based on our machine learning models and evaluation of more than 13 different immune parameters, norovirus vaccination protection most tightly associates with making a functional antibody response to norovirus in the serum (“NBAA”) and norovirus specific fecal IgA antibodies. Because of the strong induction of mucosal IgA due to the oral vaccination and potential read through into the serum, we believe that this likely means that a functional fecal IgA response is probably critical for protection against norovirus infection.

In the second half of 2024, we received constructive feedback from the U.S. Food and Drug Administration (“FDA”) on our data for potential correlates of protection and next steps for our norovirus program. While we believe we have identified a functional antibody response that may be associated with protection for norovirus, the FDA requested new clinical data before proceeding with further review of our potential correlate.

In 2024, we also created new, second-generation norovirus GI.1 and GII.4 constructs. Based on preclinical data, the second-generation norovirus GI.1 and GII.4 constructs are more potent than the first-generation norovirus constructs we previously evaluated in clinical trials.

In June 2025, we reported positive topline results from a Phase 1 clinical trial (Study VXA-109) evaluating our second-generation bivalent norovirus vaccine constructs head-to-head against our first-generation bivalent norovirus vaccine constructs. The open-label, Phase 1 trial was conducted in 60 healthy volunteers who were randomized to receive the first-generation vaccine constructs, an equivalent dose of the second-generation GI.1 and GII.4 vaccine constructs, or a lower dose of the second-generation vaccine constructs (n=20 for each group). The primary immunological endpoint was norovirus blocking antibody assay (NBAA) titer at Day 0 and Day 28. In a Phase 2 challenge study of the first-generation vaccine constructs, these functional NBAA titers were identified as correlates of protection against norovirus infection. Although the study was not powered to determine superiority by statistical methods, the increase in NBAA titers with the second-generation vaccine candidates was sufficiently large (141% for the GI.1 vaccine candidate and 94% for the GII.4 vaccine candidate) to demonstrate statistical significance at the equivalent dose.

Following the successful outcome of the VXA-109 trial, the next step, pending a partnership or other funding, would be to advance the program to the next stage of clinical development in 2026.

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Breastfeeding Mothers. In 2022, we partnered with the Bill & Melinda Gates Foundation to execute a Phase 1 norovirus bivalent vaccine candidate study in 76 healthy, lactating post-partum, women volunteers, to determine the impact of our norovirus vaccine on breast milk norovirus-specific IgA and its potential presence, post-breastfeeding, within infant fecal samples. The study was randomized, double-blinded, and placebo controlled and evaluated the safety, tolerability, and immunogenicity of the placebo cohorts and two vaccine cohorts: medium dose (1×10^11^ IU) and high dose (2×10^11^ IU). Passive transfer of antibodies from mother to infant that are induced in milk may protect breastfeeding infants from infectious pathogens. We initiated this study in the fourth quarter of 2023 and announced positive top line results in April 2024. Top line results showed antibodies rose in lactating mothers who received the high dose of our bivalent vaccine candidate. Specifically, serum antibodies to norovirus rose on average 5.6 fold in response to the GI.1 virus strain and 4.4 fold in response to the GII.4 virus strain and breast milk antibodies to norovirus rose on average 4.0 fold in response to the GI.1 virus strain and 6.0 fold in response to the GII.4 virus strain. The vaccine was well tolerated with no vaccine-related serious adverse events and no dose-limiting pharmacotoxicity. As a grant recipient from the Bill & Melinda Gates Foundation, Vaxart has agreed to a global access commitment for use of its bivalent norovirus vaccine candidate, if proven effective and approved, in breastfeeding mothers from low- and middle-income countries.

Coronavirus Vaccine. COVID-19, a severe respiratory tract infection caused by the virus SARS-CoV-2, is a major cause of hospitalization and death in the U.S. and worldwide. According to the CDC, an outbreak of COVID-19 began in Wuhan, China, in late 2019 and rapidly spread worldwide. While most COVID-19 restrictions have been lifted, COVID-19 continues to spread and remains a public health threat, not least due to the continuing emergence of new variants.

In January 2024, we were awarded a contract by the U.S. Biomedical Advanced Research and Development Authority (“HHS BARDA”), a division of the Administration for Strategic Preparedness and Response (“ASPR”) within the U.S. Department of Health and Human Services (“HHS”), for $9.3 million to fund preparation for a Phase 2b clinical study involving 10,000 participants. Vaxart executed on the deliverables and received all $9.3 million of cash payments related to this contract in 2024.

In June 2024, we entered into an agreement (as modified or amended from time to time, the “2024 ATI-RRPV Contract”) with Advanced Technology International (“ATI”), the Rapid Response Partnership Vehicle’s Consortium Management Firm funded by HHS BARDA for a Phase 2b clinical study. This Phase 2b clinical study is designed as a double-blind, multi-center, randomized, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19 infection. The 2024 ATI-RRPV Contract initially provided for funding of up to $460.7 million to conduct this Phase 2b study, manufacture a COVID-19 vaccine candidate targeting the KP.2 strain, and acquire an approved mRNA vaccine targeting the KP.2 strain.

In the second half of 2024, we initiated and completed enrollment of the sentinel cohort of the Phase 2b study consisting of 400 participants comparing our XBB COVID-19 vaccine candidate against an approved mRNA XBB comparator. In January 2025, an independent data safety monitoring board (“DSMB”) recommended the study to proceed without modifications based on initial safety assessment of 30-day data from the sentinel cohort. Additional data regarding the 12-month follow-up for these 400 individuals is anticipated to be shared in the first half of 2026.

In February 2025, we received written notification from ATI in the form of a stop work order (the “February 2025 SWO”) directing the Company to stop work on the 2024 ATI-RRPV Contract, with the exception that we could continue efforts associated with the per protocol follow-up for the 400-participant sentinel cohort. The February 2025 SWO was to be in effect for a period of 90 days.

Subsequently, in April 2025, the Company received written notification from ATI in the form of a stop work order lift (the “Lift Notice”) that the February 2025 SWO had been lifted and that the Company may resume incurring costs, participating in meetings, and communicating with the Government and ATI concerning the project award.

In May 2025, following additional discussion between the Company and HHS BARDA regarding costs, timelines, and regulatory pathway, we received approval from HHS BARDA to initiate dosing. We subsequently proceeded to dose patients in the 10,000-participant portion of the Phase 2b clinical study.

In August 2025, the Company received written notification from ATI in the form of a second stop work order (the “August 2025 stop work order”) directing the Company to stop work on screening and enrollment for the 10,000-person cohort of the Phase 2b clinical study. The Company was, however, permitted to continue efforts associated with the per protocol follow-up to the extent study participants were already dosed. As of the notification date, the Company had enrolled approximately half of the targeted number of participants for the study. The funding under the 2024 ATI-RRPV Contract is currently under review in light of the August 2025 stop work order and is likely to be reduced in line with the reduced enrollment of approximately 5,000 participants vs. the original planned enrollment of 10,000 participants in the main cohort of the Phase 2b study.

In September 2025, ATI increased the total amount of funding available for payment to approximately $305.0 million.

On October 8, 2025, the Company received another notice (the “Follow-Up Notice”) from ATI, clarifying the scope of the 2024 ATI-RRPV Contract. The Follow-Up Notice sets forth that BARDA intends to stop all work under the 2024 ATI-RRPV Contract except for efforts in support of participants already enrolled in the study, who will continue to be followed.

Based on our understanding of the currently agreed scope, we anticipate that the Phase 2b study, which enrolled healthy adults 18 years and older in the U.S. with 400 participants from the sentinel cohort and approximately 5,000 participants enrolled from the main cohort as of our receipt of the August stop work order, will continue to collect participant data over a 12 month period post-vaccination and will continue to be funded under the 2024 ATI-RRPV Contract. Out of the approximately 5,400 total participants, we expect approximately 2,700 to have received our COVID-19 vaccine candidate and approximately 2,700 to have received an approved strain-matched mRNA comparator. The study has been conducted to enroll participants in line with U.S. demographics, as well as to include at least 25% over the age of 65.

The Phase 2b study will measure efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and the incidence of adverse events. The primary endpoint is relative efficacy of Vaxart’s COVID-19 vaccine candidate compared to an approved mRNA comparator for the prevention of symptomatic disease. Primary efficacy analysis will be performed when all participants have either discontinued or completed a study visit 12 months post-vaccination.

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Influenza Vaccine. Flu is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and sometimes the lungs. An estimated one billion cases of seasonal influenza occur annually worldwide, of which three to five million cases are considered severe, causing 290,000 to 650,000 deaths per year. In the United States, between 9,000,000 to 41,000,000 people catch influenza annually, between 140,000 and 710,000 people are hospitalized with complications of influenza, and between 12,000 and 52,000 people die from influenza and its complications each year.

Monovalent influenza vaccine. **** In 2018, we completed a Phase 2 challenge study of our H1N1 flu vaccine candidate, which was funded through a $15.7 million contract with HHS BARDA. We announced that, in healthy volunteers immunized and then experimentally infected with H1 influenza, our H1 influenza oral tablet vaccine candidate reduced clinical disease by 39% relative to placebo. Fluzone, the market-leading injectable quadrivalent influenza vaccine, reduced clinical disease by 27%. Our tablet vaccine candidate also showed a favorable safety profile, indistinguishable from placebo.

We also presented data from the study demonstrating that our vaccine candidate elicited a significant expansion of mucosal homing receptor plasmablasts to approximately 60% of all activated B cells. We believe these mucosal plasmablasts are a key indicator of a protective mucosal immune response and a unique feature of our vaccine candidates.

***Avian influenza vaccine.***We continue to advance our avian influenza program. We previously published data demonstrating protection in a preclinical model against avian influenza after oral immunization (Clin Vaccine Immunol 2013). We recently created a new avian influenza vaccine candidate to cover the latest clade 2.3.4.4b. The new avian influenza vaccine was 100% protective against death in a robust ferret clade 2.3.4.4b challenge model compared to 0% survival in placebo treated animals. Additional details will be presented in upcoming scientific conferences and published in a scientific paper.

Next Steps

The Company intends to work with governments around the world to create pandemic monovalent influenza vaccines for emergency use or stockpiling, if requested. We are also continuing development of our preclinical tri-valent seasonal influenza vaccine candidate.

HPV Therapeutic Vaccine**.** Cervical cancer is the fourth most common cancer in women worldwide and in the United States with about 13,000 new cases diagnosed annually in the United States according to the National Cervical Cancer Coalition. Our first therapeutic oral vaccine candidate targets HPV 16 and HPV 18, the two strains responsible for 70% of cervical cancers and precancerous cervical dysplasia.

We are in the early stages of developing a bivalent HPV vaccine against HPV-16 and HPV-18, the strains responsible for approximately 70% of cases of cervical cancer. We plan to target the E6 and E7 gene products of each strain, which are the primary oncogenic proteins responsible for progression through the stages of CIN to invasive cervical cancer. In pre-clinical studies, we have demonstrated immunogenicity for both our HPV-16 and our HPV-18 vaccine candidates. Specifically, mice given our HPV-16 or HPV-18 vaccines induced T cell responses to HPV as measured by IFN gamma ELISPOT. In addition, our HPV-16 vaccine has demonstrated tumor growth suppression as well as increased survival in a robust HPV tumor model in mice.

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Next Steps

We will need to make a regulatory filing to proceed with clinical trials for an HPV vaccine candidate. Our clinical plan is to test the vaccine candidate in subjects with cervical dysplasia related to HPV-16 or HPV-18, and to evaluate the ability of the vaccine candidate to clear HPV infection, reduce the cervical dysplasia score, and induce T cells known to be important in the clearance of HPV. The primary endpoint will be safety and the secondary endpoint will be immunogenicity by examining T cell responses.

Antivirals

Through the Merger, we acquired two royalty earning products, Relenza and Inavir. We also acquired three Phase 2 clinical stage antiviral compounds, of which we have discontinued independent clinical development. However, for one of these, Vapendavir, we have entered into an exclusive worldwide license agreement with Altesa Biosciences, Inc. (“Altesa”) in July 2021, permitting Altesa to develop and commercialize this capsid-binding broad-spectrum antiviral. In May 2025, Altesa announced positive topline results from its Phase 2 placebo-controlled study examining the effects of Vapendavir in chronic obstructive pulmonary disease (“COPD”) patients challenged with rhinovirus. In September 2025, Altesa announced its intent to proceed, in collaboration with bioMérieux, with a randomized, double-blind, placebo-controlled study examining the safety and efficacy of Vapendavir to treat rhinovirus infections in patients with COPD.
Relenza and Inavir are antivirals for the treatment of influenza, marketed by GlaxoSmithKline, plc (“GSK”) and Daiichi Sankyo Company, Limited (“Daiichi Sankyo”), respectively. We have earned royalties on the net sales of Relenza and Inavir in Japan. The last patent for Relenza expired in July 2019 based on information provided by Daiichi Sankyo, and the last patent for Inavir expires in August 2036. Sales of these antivirals vary significantly by quarter, because influenza virus activity displays strong seasonal cycles, and by year depending on the intensity and duration of the flu season, the impact COVID-19 has had, and may continue to have, on seasonal influenza, and competition from other antivirals such as Tamiflu and Xofluza.
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Financial Operations Overview

Revenue

Non-Cash Royalty Revenue Related to S al e of Future R oyalties

In April 2016, Aviragen sold certain royalty rights related to Inavir in the Japanese market for $20.0 million to HealthCare Royalty Partners III, L.P. (“HCRP”). Under the terms of our agreement with HCRP, during the first royalty interest period of April 1, 2016 through March 31, 2025, HCRP is entitled to the first $3.0 million and any cumulative remaining shortfall amount plus 15% of the next $1.0 million in royalties earned in each year commencing on April 1, with any excess revenue being retained by us. Further, during the second royalty interest period beginning April 1, 2025 and ending on December 24, 2029, HCRP is entitled to the first $2.7 million and any cumulative remaining shortfall amount plus 15% of the next $1.0 million in royalties, with any excess revenue being retained by us. A shortfall occurs when, during an annual period ending on March 31^st^, for the first royalty interest period of April 1, 2016 through March 31, 2025, royalty payments fall below $3.0 million; and $2.7 million for the second royalty interest period of April 1, 2025 and ending on December 24, 2029, excluding the period of April 1, 2028 through December 24, 2029. In the event there is a remaining cumulative remaining shortfall amount as of December 24, 2029, then, for so long as the Company continues to receive royalties from Daiichi Sankyo Company Limited (“Daiichi Sankyo”), the sum of those royalties will be paid to HCRP until the cumulative remaining shortfall amount has been paid in full.

We are not obligated to pay HCRP any royalty payment beyond what we are paid by Daiichi Sankyo. The cumulative remaining shortfall amount is the aggregate amount of the shortfall for each annual period, which was $4.4 million as of September 30, 2025.

Even though we do not currently retain the related royalties under the transaction, as the amounts are remitted to HCRP, we will continue to record revenue related to these royalties until the amount of the associated liability and related interest is fully amortized.

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Revenue from Government Contracts

In January 2024, we were awarded the 2024 ASPR-BARDA Contract by HHS BARDA, with a base and all options value of $9.3 million. Under the 2024 ASPR-BARDA Contract, we received an award to support clinical trial planning activities for a Phase 2b clinical trial that would compare our XBB vaccine candidate to an mRNA comparator to evaluate efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and adverse events. Revenue from government contracts recognized on the 2024 ASPR-BARDA Contract was $0.6 and $0.9 million for the three months ended September 30, 2025 and 2024, respectively, and $0.6 and $8.7 million for the nine months ended September 30, 2025 and 2024, respectively, based on the achievement of certain milestones under the 2024 ASPR-BARDA Contract.

In June 2024, we entered into the 2024 ATI-RRPV Contract. In the second half of 2024, the 2024 ATI-RRPV Contract was modified to increase funding and expand the scope to include the manufacture of a vaccine candidate targeting the KP.2 strain and acquire an approved mRNA vaccine targeting the KP.2 strain. Pursuant to the 2024 ATI-RRPV Contract (as modified or amended from time to time), we were to receive funding of up to $460.7 million to conduct a Phase 2b comparative study evaluating our oral pill COVID-19 vaccine candidate against an mRNA vaccine comparator approved by the FDA. The 2024 ATI-RRPV Contract makes available an aggregate amount of up to $305.0 million, consisting of firm fixed price amounts totaling $67.9 million and reimbursement of costs incurred in trial preparation and execution activities. The 2024 ATI-RRPV Contract further contemplates additional funding up to $155.7 million if we and HHS BARDA decide to continue with the Phase 2b comparative study. This additional funding under the 2024 ATI-RRPV Contract is currently under review in light of the August 2025 stop work order and is likely to be reduced in line with the reduced enrollment of approximately 5,000 participants vs. the original planned enrollment of 10,000 participants in the main cohort of the Phase 2b study. Revenue from government contracts recognized on the 2024 ATI-RRPV Contract was $71.8 million and $4.0 million for the three months ended September 30, 2025 and 2024, respectively, and $130.8 million and $4.2 million for the nine months ended September 30, 2025 and 2024, respectively, based on costs incurred and the achievement of firm fixed-price milestones under the 2024 ATI-RRPV Contract. For further information about the August 5, 2025 stop work order relating to the 2024 ATI-RRPV Contract, see the section above titled “—Our Product Pipeline” in the “Coronavirus Vaccine” discussion.

Research and Development Expenses

Research and development expenses represent costs incurred on conducting research, such as developing our tablet vaccine platform, and supporting preclinical and clinical development activities of our tablet vaccine candidates. We recognize all research and development costs as they are incurred. Research and development expenses consist primarily of the following:

employee-related expenses, which include salaries, benefits and stock-based compensation;
expenses incurred under agreements with contract research organizations (“CROs”), that conduct clinical trials on our behalf;
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expenses incurred under agreements with contract manufacturing organizations (“CMOs”), that manufacture product used in the clinical trials;
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expenses incurred in procuring materials and for analytical and release testing services required to produce vaccine candidates used in clinical trials;
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process development expenses incurred internally and externally to improve the efficiency and yield of the bulk vaccine and tablet manufacturing activities;
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laboratory supplies and vendor expenses related to preclinical research activities;
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consultant expenses for services supporting our clinical, regulatory and manufacturing activities; and
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facilities, depreciation and allocated overhead expenses.
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We do not allocate our internal expenses to specific programs. Our employees and other internal resources are not directly tied to any one research program and are typically deployed across multiple projects. Internal research and development expenses are presented as one total.

We have incurred significant external costs for CROs that conduct clinical trials on our behalf. We have captured these external costs for each vaccine program. We do not allocate external costs incurred on preclinical research or process development to specific programs.

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The following table shows our period-over-period research and development expenses, identifying external costs that were incurred in each of our vaccine programs and, separately, on preclinical research and process development for the three and nine months ended September 30, 2025 and 2024 (in thousands):

Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
External program costs:
Norovirus program $ 519 $ 821 $ 3,227 $ 2,560
COVID-19 program 66,220 1,513 118,413 7,849
Other programs 2 346 16
Preclinical research 98 216 722 1,596
Process development 106 46 189
Total external costs 66,837 2,658 122,754 12,210
Internal costs 9,110 12,408 33,672 39,349
Total research and development $ 75,947 $ 15,066 $ 156,426 $ 51,559

We expect to incur significant research and development expenses in the remainder of 2025 and beyond as we advance our tablet vaccine candidates into and through clinical trials, pursue regulatory approval of our tablet vaccine candidates and prepare for a possible commercial launch, all of which will also require a significant investment in manufacturing and inventory related costs. To the extent that we enter into licensing, partnering or collaboration agreements, a significant portion of such costs may be borne by third parties.

The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in achieving marketing approval for our tablet vaccine candidates. The probability of successful commercialization of our tablet vaccine candidates may be affected by numerous factors, including clinical data obtained in future trials, competition, manufacturing capability and commercial viability. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our tablet vaccine candidates.

General and Administrative Expense

General and administrative expenses consist of personnel costs, insurance, allocated expenses and expenses for outside professional services, including legal, audit, accounting, public relations, market research and other consulting services. Personnel costs consist of salaries, benefits and stock-based compensation. Allocated expenses consist of rent, depreciation and other facilities-related expenses.

Results of Operations

As we continue to explore commercial opportunities, and plan to work with business partners, in both U.S. and international markets, we remain attentive to evolving global economic conditions, including uncertainties related to international trade policies, tariffs, and supply chain dynamics. Although these factors have not had a material impact on our operations to date, future changes in trade regulations, tariff structures, or logistical constraints could influence the cost, availability, or timing of materials, services and other components associated with the development of our tablet vaccines and manufacturing capabilities. We continue to monitor these developments closely to maintain operational efficiency and help mitigate potential future impacts.

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The following table presents period-over-period changes in selected items in the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2025 and 2024 (in thousands, except percentages):

Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 % Change 2025 2024 % Change
Revenue $ 72,413 $ 4,933 1,368 % $ 133,019 $ 13,515 884 %
Operating expenses 80,224 19,408 313 % 170,368 68,316 149 %
Operating loss (7,811 ) (14,475 ) (46 )% (37,349 ) (54,801 ) (32 )%
Net non-operating expense (313 ) 413 (176 )% (1,237 ) (78 ) 1,486 %
Loss before income taxes (8,124 ) (14,062 ) (42 )% (38,586 ) (54,879 ) (30 )%
Provision for income taxes 17 18 (6 )% 132 84 57 %
Net loss $ (8,141 ) $ (14,080 ) (42 )% $ (38,718 ) $ (54,963 ) (30 )%

Total Revenue

The following table summarizes the period-over-period changes in our revenues for the three and nine months ended September 30, 2025 and 2024 (in thousands, except percentages):

Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 % Change 2025 2024 % Change
Non-cash royalty revenue related to sale of future royalties $ $ 40 (100 )% $ 1,579 $ 662 139 %
Revenue from government contracts 72,413 4,893 1,380 % 131,440 12,853 923 %
Total revenue $ 72,413 $ 4,933 1,368 % $ 133,019 $ 13,515 884 %

Non-cash R oyalty R evenue Related to Sale of Future Royalties

For the three months ended September 30, 2025 and 2024, non-cash royalty revenue related to sale of future royalties from Daiichi Sankyo was zero and $40,000, respectively, and for the nine months ended September 30, 2025 and 2024, was $1.6 million and $0.7 million, respectively. We continue to have non-cash royalty revenue as all royalties received for the three and nine months ended September 30, 2025 and 2024 were required to be paid to HCRP.

Revenue from Government Contracts

For the three months ended September 30, 2025 and 2024, revenue from government contracts was $72.4 million and $4.9 million, respectively, and for the nine months ended September 30, 2025 and 2024, was $131.4 million and $12.9 million, respectively. The revenue from government contracts consists of the 2024 ASPR-BARDA Contract awarded to us in January 2024 and the 2024 ATI-RRPV Contract awarded to us in June 2024. Revenue from the 2024 ASPR-BARDA Contract was $0.6 million and $0.9 million for the three months ended September 30, 2025 and 2024, respectively, and $0.6 million and $8.7 million for the nine months ended September 30, 2025 and 2024, respectively. Revenue from the ATI-RRPV Contract was $71.8 million and $4.0 million for the three months ended September 30, 2025 and 2024, respectively, and $130.8 million and $4.2 million for the nine months ended September 30, 2025 and 2024, respectively.

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Total Operating Expenses

The following table summarizes the period-over-period changes in our operating expenses for the three and nine months ended September 30, 2025 and 2024 (in thousands, except percentages):

Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 % Change 2025 2024 % Change
Research and development $ 75,947 $ 15,066 404 % $ 156,426 $ 51,559 203 %
General and administrative 4,277 4,342 (1 )% 13,942 16,757 (17 )%
Total operating expenses $ 80,224 $ 19,408 313 % $ 170,368 $ 68,316 149 %

Re search and Development

For the three months ended September 30, 2025, research and development expenses increased by $60.9 million, or 404%, compared to the three months ended September 30, 2024. The increase was primarily due to an increase in clinical trial expenses related to our COVID-19 vaccine candidate, partially offset by a decrease in preclinical, manufacturing expenses and personnel costs.

For the nine months ended September 30, 2025, research and development expenses increased by $104.9 million, or 203%, compared to the nine months ended September 30, 2024. The increase was primarily due to an increase in clinical trial expenses related to our COVID-19 and norovirus vaccine candidates, partially offset by a decrease in manufacturing and personnel costs.

General and Administrative

For the three months ended September 30, 2025, general and administrative expenses decreased by $0.1 million, or 1%, compared to the three months ended September 30, 2024. The net decrease was primarily due to a decrease in insurance, recruiting costs, and legal fees, partially offset by an increase in professional fees.

For the nine months ended September 30, 2025, general and administrative expenses decreased by $2.8 million, or 17%, compared to the nine months ended September 30, 2024. The decrease was primarily due to a decrease in personnel costs, legal and professional fees.

Non-Operating Income (Expense)

The following table summarizes the period-over-period changes in our non-operating income for the three and nine months ended September 30, 2025 and 2024 (in thousands, except percentages):

Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 % Change 2025 2024 % Change
Interest income $ 302 $ 1,022 (70 )% $ 1,049 $ 1,941 (46 )%
Non-cash interest expense related to sale of future royalties (608 ) (631 ) (4 )% (2,277 ) (2,045 ) 11 %
Other income (expense), net (7 ) 22 (132 )% (9 ) 26 (135 )%
Net non-operating expense $ (313 ) $ 413 (176 )% $ (1,237 ) $ (78 ) 1,486 %

For the three months ended September 30, 2025, we recorded interest income of $0.3 million, a 70% decrease from the $1.0 million interest income recorded in the three months ended September 30, 2024. For the nine months ended September 30, 2025, we recorded interest income of $1.0 million, a 46% decrease from the $1.9 million of interest income recorded in the nine months ended September 30, 2024. The decrease is primarily due to the decrease in our cash, cash equivalents and investments balance.

Non-cash interest expense related to sale of future royalties representing imputed interest on the unamortized portion of the sale of future royalties liability, was $0.6 million for the three months ended September 30, 2025, comparable with the $0.6 million for the three months ended September 30, 2024, and increased to $2.3 million for the nine months ended September 30, 2025, from the $2.0 million for the nine months ended September 30, 2024, due to an increase in non-cash royalty revenue payable to HCRP.

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Provision for Income Taxes

The following table summarizes the period-over-period changes in our provision for income taxes for the three and nine months ended September 30, 2025 and 2024 (in thousands, except percentages):

Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 % Change 2025 2024 % Change
Foreign withholding tax on royalty revenue $ $ 2 (100 )% $ 79 $ 33 139 %
Foreign taxes payable on intercompany interest 17 16 6 % 50 48 4 %
State income taxes % 3 3 %
Provision for income taxes $ 17 $ 18 (6 )% $ 132 $ 84 57 %

The provision for income taxes was $17,000 and $18,000 for the three months ended September 30, 2025 and 2024, respectively, and $132,000 and $84,000 for the nine months ended September 30, 2025 and 2024, respectively. The tax charge relates to interest on an intercompany loan from a foreign subsidiary, and a 5% withholding tax on royalty revenue earned on sales of Inavir in Japan, which is potentially recoverable as a foreign tax credit but expensed because we record a 100% valuation allowance against our deferred tax assets. The amount of foreign withholding tax expense recorded is directly proportional to Inavir royalties, including the portion that we pass through to HCRP.

In July 2025, the One Big Beautiful Bill Act ("OBBBA") was enacted, introducing a series of corporate tax changes in the U.S., including 100% bonus depreciation on qualified property and full expensing for research and development expenditures. The impacts of the OBBBA, are reflected in our results for the quarter ended September 30, 2025. The Act is not expected to have a material impact on the Company’s effective income tax rate and its net deferred federal income tax assets as the Company maintains a full valuation allowance.

Liquidity and Capital Resources

We are a clinical-stage biotechnology company with no product sales. Our primary source of financing is from the sale and issuance of common stock as well as funding from HHS BARDA. In the past, we have also obtained funds from the issuance of common stock warrants, secured debt and preferred stock and from collaboration agreements.

In March 2025, the Company entered into an At the Market Offering Agreement (the “March 2025 ATM”) with Citizens JMP Securities, LLC (“Citizens”) and B. Riley Securities, Inc. (“B. Riley” and, together with Citizens, the “Managers”), pursuant to which the Company may offer and sell, from time to time through the Managers, shares of its common stock having an aggregate offering price of up to $50 million. The shares will be sold pursuant to an effective registration statement on Form S-3 (Registration Statement No. 333-270671), as previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The Company filed a prospectus supplement, dated March 21, 2025, with the SEC in connection with the offer and sale of the shares under the March 2025 ATM. The Company will pay the Managers a placement fee of up to 3% of the gross sale price from each sale of the shares under the March 2025 ATM. During the nine months ended September 30, 2025, 382,700 shares were issued and sold under the March 2025 ATM for gross proceeds of $0.2 million, which, after deducting sales commissions and expenses incurred to date, resulted in net proceeds of $0.1 million. As of September 30, 2025, approximately $48.4 million of our common stock remained available for issuance and sale pursuant to the March 2025 ATM. However, we are unable to leverage the ATM at this time because our common stock has been suspended from trading on The Nasdaq Capital Market.

On September 19, 2025, the Company was notified that its securities will be delisted from The Nasdaq Stock Market (“Nasdaq”) due to the Company’s noncompliance with certain conditions set forth by the Nasdaq Hearings Panel (the “Panel”) to continue the Company’s listing on Nasdaq, one of which was to receive shareholder approval for a reverse stock split. The Company withdrew its proposal to effect a reverse stock split of its common stock on September 18, 2025. The National Securities Markets Improvement Act of 1996 prevents or preempts the states from regulating the sale of certain securities, which are referred to as “covered securities.” Once Nasdaq has officially delisted our securities, our securities would not be covered securities since OTCQX-traded securities are not considered covered securities, and we will need to follow each state’s blue sky laws for offers and sales of our securities made to residents of that state. This state level regulation introduces additional compliance requirements for brokers to consider when trading in our securities and will further negatively impact any trading liquidity in our securities.

In January 2024, we entered into a securities purchase agreement (the “2024 Securities Purchase Agreement”) with RA Capital Healthcare Fund, L.P. pursuant to which 15,384,615 shares of our common stock were sold to RA Capital Healthcare Fund, L.P. at an offering price of $0.65 per share. The gross proceeds from the 2024 Securities Purchase Agreement were $10.0 million and, after deducting offering expenses, the net proceeds were $9.9 million.

In January 2024, we were awarded the 2024 ASPR-BARDA Contract with a base and all options value of $9.3 million. Under the 2024 ASPR-BARDA Contract, we received an award to support clinical trial planning activities for a Phase 2b clinical trial that would compare our XBB vaccine candidate to an mRNA comparator to evaluate efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and adverse events. The 2024 ASPR-BARDA Contract originally had a period of performance term that was set to expire in July 2024, but we entered into an amendment in July 2024 that extended the period of performance expiration date into October 2024. During 2024, we received approximately $9.3 million of cash payments under the 2024 ASPR-BARDA Contract.

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In June 2024, we entered into an underwriting agreement with Oppenheimer & Co. Inc., relating to the issuance and sale by us in an underwritten registered direct offering (the “June 2024 Offering”) of 50,000,000 shares of our common stock at a price of $0.80 per share. The gross proceeds to us from such offering were $40.0 million, and after deducting the underwriting discounts and commissions and other offering expenses paid by us, the net proceeds were $37.5 million.

In June 2024, we entered into the 2024 ATI-RRPV Contract. Pursuant to the 2024 ATI-RRPV Contract, we were to receive funding of up to $460.7 million to conduct a Phase 2b comparative study evaluating our oral pill COVID-19 vaccine candidate against an mRNA vaccine comparator approved by the FDA, manufacture a COVID-19 vaccine candidate targeting the KP.2 strain, and acquire an approved mRNA vaccine targeting the KP.2 strain. As of September 30, 2025, we have received $125.9 million of cash payments under the 2024 ATI-RRPV Contract. Subsequent to September 30, 2025, through the filing date of this Quarterly Report on Form 10-Q, we have received $42.7 million under the 2024 ATI-RRPV Contract. On August 5, 2025, the Company received written notification from ATI in the form of a stop work order directing the Company to stop work on screening and enrollment for the COVID-19 Phase 2b trial under the 2024 ATI-RRPV Contract as of the notification date. On October 8, 2025, the Company received a follow-up notice from ATI, which indicated that BARDA intends to conclusively exclude work subject to the foregoing stop work order from the 2024 ATI-RRPV Contract. The Company may, however, continue efforts associated with the per protocol follow-up of all participants dosed as of the notification date in the study under the terms of the 2024 ATI-RRPV Contract. As of the August notification date, the Company had enrolled approximately half of the targeted number of participants for the study. Management is currently evaluating the effect of the stop work order on its liquidity and capital resources.

As of September 30, 2025, we had approximately $28.8 million of cash, cash equivalents and short-term investments. Our cash, cash equivalents and investments are not sufficient to fund our planned operations for a period of 12 months from the date of issuance of this Quarterly Report. To continue operations, we expect that we will need to raise further capital, through the sale of additional securities or otherwise; however, adequate funding may not be available to us on acceptable terms, or at all, particularly in light of current economic uncertainty, high interest rates, rising inflation, tariffs, and the potential for local and/or global economic recession. Our future capital requirements and the adequacy of our available funds will depend on many factors, most notably our ability to successfully commercialize our products and services.

We may fund a significant portion of our ongoing operations through partnering and collaboration agreements which, while reducing our risks and extending our cash runway, will also reduce our share of eventual revenues, if any, from our vaccine candidates. We may be able to fund certain activities with assistance from government programs. The sale of additional equity would result in additional dilution to our stockholders. We may also fund our operations through debt financing, which would result in debt service obligations, and the instruments governing such debt could provide for operating and financing covenants that would restrict our operations. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we may be required to delay, limit, reduce, or terminate our product development or future commercialization efforts or grant rights to develop and market vaccine candidates that we would otherwise prefer to develop and market ourselves. Any of these actions could harm our business, results of operations and prospects.

Based on management’s current plan, which reflects updated assumptions based on events occurring after September 30, 2025, we expect to have cash runway into the second quarter of 2027. See Note 12 to the Condensed Consolidated Financial Statements in Part I, Item 1 for further details. Accordingly, management concluded that the conditions and events that previously raised substantial doubt about our ability to continue as a going concern have been alleviated. The accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business.

Our future funding requirements will depend on many factors, including the following:

the timing and costs of our planned preclinical studies for our product candidates;
the timing and costs of our planned clinical trials of our product candidates;
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our manufacturing capabilities, including the availability of contract manufacturing organizations to supply our product candidates at reasonable cost;
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the amount and timing of royalties received on sales of Inavir;
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the number and characteristics of product candidates that we pursue;
the outcome, timing and costs of seeking regulatory approvals;
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revenue received from commercial sales of our future products, which will be subject to receipt of regulatory approval;
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the terms and timing of any future collaborations, licensing, consulting or other arrangements that we may enter into;
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the amount and timing of any payments that may be required in connection with the licensing, filing, prosecution, maintenance, defense and enforcement of any patents or patent applications or other intellectual property rights;
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the current economic uncertainty, high interest rates, rising inflation, tariffs, and the potential for local and/or global economic recession;
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our ability to maintain an active trading market for our common stock that would provide adequate liquidity to investors; and
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the extent to which we in-license or acquire other products and technologies.
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Cash Flows

The following table summarizes our cash flows for the periods indicated (in thousands):

Nine Months Ended September 30,
2025 2024
Net cash used in operating activities $ (22,949 ) $ (37,419 )
Net cash provided by (used in) investing activities 14,643 (31,727 )
Net cash (used in) provided by financing activities (43 ) 56,426
Net decrease in cash and cash equivalents $ (8,349 ) $ (12,720 )

Net Cash Used in Operating Activities

We experienced negative cash flow from operating activities for the nine months ended September 30, 2025 and 2024, in the amounts of $22.9 million and $37.4 million, respectively. The cash used in operating activities in the nine months ended September 30, 2025, was due to cash used to fund a net loss of $38.7 million, partially offset by an increase in working capital of $5.1 million (consisting of an increase in accounts payable and clinical accruals and partially offset by an increase in receivables from government contracts), and adjustments for net non-cash expenses related to depreciation and amortization, accretion of discount on investments, net, stock-based compensation, non-cash interest expense related to sale of future royalties and non-cash revenue related to sale of future royalties totaling $10.7 million. The cash used in operating activities in the nine months ended September 30, 2024, was due to cash used to fund a net loss of $55.0 million and an increase in working capital of $3.8 million, partially offset by adjustments for net non-cash income related to depreciation and amortization, amortization of discount on investments, net, stock-based compensation, non-cash interest expense related to sale of future royalties and non-cash revenue related to sale of future royalties totaling $13.7 million.

Net Cash Provided by (Used in) Investing Activities

In the nine months ended September 30, 2025, we received $14.8 million from maturities of investments, net of purchases, and used $0.1 million to purchase property and equipment, net of proceeds. In the nine months ended September 30, 2024, we used $31.2 million to purchase investments, net of maturities, and used $0.5 million of cash to purchase property and equipment.

Net Cash (Used in) Provided by Financing Activities

In the nine months ended September 30, 2025, we used $0.2 million to acquire common stock to settle employee tax withholding liabilities, and received net proceeds of $53,000 from the sale of our common stock under the March 2025 ATM. In the nine months ended September 30, 2024, we received net proceeds of $37.5 million from the sale of our common stock under the June 2024 Offering, net proceeds of $8.8 million from the sale of our common stock under the September 2021 ATM and net proceeds of $9.9 million from the sale of our common stock under the 2024 Securities Purchase Agreement, partially offset by $0.2 million from common stock acquired to settle employee tax withholding liabilities.

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Contractual Obligations and Commercial Commitments

We have the following contractual obligations and commercial commitments as of September 30, 2025 (in thousands):

Contractual Obligation Total < 1 Year 1 - 3 Years 3 - 5 Years > 5 Years
Long Term Debt, HCRP $ 17,000 $ 2,732 $ 5,520 $ 5,520 $ 3,228
Operating Leases 18,214 4,998 10,506 2,710
Purchase Obligations 24,561 24,561
Total $ 59,775 $ 32,291 $ 16,026 $ 8,230 $ 3,228

Long Term Debt, HCRP. Under an agreement executed in 2016, during the first royalty interest period of April 1, 2016 through March 31, 2025, we are obligated to pay HCRP the first $3.0 million and any cumulative remaining shortfall amount plus 15% of the next $1.0 million in royalties earned in each year commencing on April 1, with any excess revenue being retained by us. Further, during the second royalty interest period beginning April 1, 2025 and ending on December 24, 2029, HCRP is entitled to the first $2.7 million and any cumulative remaining shortfall amount plus 15% of the next $1.0 million in royalties, with any excess revenue being retained by us. See Note 6 to the Condensed Consolidated Financial Statements in Part I, Item 1 for further details.

Operating leases. Operating lease amounts include future minimum lease payments under all our non-cancelable operating leases with an initial term in excess of one year.

Purchase obligations. As of September 30, 2025, the Company had approximately $24.5 million of non-cancelable purchase commitments, principally for clinical services which are expected to be paid within the next year. Approximately $23.4 million of non-cancelable purchase commitments are attributable to a third-party vendor that provides clinical services, that is reimbursable at approximately $25.2 million under a cost-plus-fixed-fees arrangement in the ATI-RRPV Contract.

Critical Accounting Policies and Estimates

Our management’s discussion and analysis of financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. On an ongoing basis, we evaluate these estimates and judgments. We base our estimates on historical experience and on various assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially from these estimates. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.

Accrued Research and Development Expenses

We record accrued expenses for estimated costs of research and development activities conducted by third-party service providers, which include the conduct of preclinical studies and clinical trials, and contract manufacturing activities. We record the estimated costs of research and development activities based upon the estimated amount of services provided and include the costs incurred but not yet invoiced within other accrued liabilities in the condensed consolidated balance sheets and within research and development expense in the condensed consolidated statements of operations and comprehensive loss. These costs can be a significant component of our research and development expenses.

We estimate the amount of work completed through discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services. We make significant judgments and estimates in determining the accrued balance in each reporting period. As actual costs become known, we adjust our accrued estimates.

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Intangible Assets

Intangible assets comprise developed technology and intellectual property. Intangible assets are carried at cost less accumulated amortization. Amortization is computed using the straight-line method over useful life of 11.75 years for developed technology and 20 years for intellectual property. The fair value as of September 30, 2025 is being amortized on a straight-line basis over the remaining period of 4.1 years and 2.3 years for developed technology and intellectual property, respectively.

Revenue from Government Contracts

Under firm fixed-price milestone contracts, we recognize the firm fixed-price revenue as the milestones are substantially complete and the firm fixed-price for the milestone is earned (“firm fixed-price milestone”). Cash received in advance of the completion of a firm fixed-price milestone will be recorded as deferred revenue until the milestone has been substantially completed and earned. Under cost reimbursable contracts, we recognize revenue as allowable costs are incurred and the fixed fee is earned (“cost-plus-fixed-fee”). Reimbursable costs under the contract primarily include direct labor, subcontract costs, materials, equipment, travel, and approved overhead and indirect costs. Fixed fees under cost reimbursable contracts are earned in proportion to the allowable costs incurred in performance of the work relative to total estimated contract costs, with such costs incurred representing a reasonable measurement of the proportional performance of the work completed.

Payments to us under cost reimbursable contracts are provisional payments subject to adjustment upon annual audit by the government. Management believes that revenue for periods not yet audited has been recorded in amounts that are expected to be realized upon final audit and settlement. When the final determination of the allowable costs for any year has been made, revenue and billings may be adjusted accordingly in the period that the adjustment is known.

Stock-Based Compensation

We measure the fair value of all stock option awards to employees, non-executive directors and consultants on the grant date, and record the fair value of these awards, net of estimated forfeitures, as compensation expense over the service period. The fair value of options is estimated using the Black-Scholes valuation model and the expense recorded is affected by subjective assumptions regarding a number of variables, as follows:

Expected term – This represents the period that our stock-based awards granted are expected to be outstanding and is determined using the simplified method (the arithmetic average of its original contractual term and its average vesting term). We have very limited historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for our stock-based awards. Based on the weighted average applied to options awarded in the nine months ended September 30, 2025, a notional 10% decrease in expected term would have reduced the fair value and the related compensation expense by approximately 2.2%.

Expected volatility – This is a measure of the amount by which our common stock price has fluctuated or is expected to fluctuate. Since the beginning of 2020, we have measured volatility based on the historical volatility of our own stock over the retrospective period corresponding to the expected term of the options on the measurement date. Based on the weighted average applied to options awarded in the nine months ended September 30, 2025, a notional 10% decrease in expected volatility (from 126.6% to 113.9%) would have reduced the fair value and the related compensation expense by approximately 4.2%.

Risk-free interest rate – This is based on the U.S. Treasury yield curve on the measurement date corresponding with the expected term of the stock-based awards.

Expected dividend – We have not made any dividend payments and do not plan to pay dividends in the foreseeable future. Therefore, we use an expected dividend yield of zero.

Forfeiture rate – This is a measure of the number of awards that are expected to not vest and is reassessed quarterly. An increase in the estimated forfeiture rate will cause a small decrease to the related compensation expense early in the service period, but since the final expense recorded for each award is the number of options vested times their grant date fair value, it has no impact on the total expense recorded.

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Recent Accounting Pronouncements

See the “Recent Accounting Pronouncements” in Note 2 to the Condensed Consolidated Financial Statements in Part I, Item 1 for information related to the issuance of new accounting standards to date. We are currently assessing the impact those new standards will have on the consolidated financial statements.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Interest Rate Sensitivity

Our exposure to market risk for changes in interest rates relates primarily to our investments in marketable debt securities. The primary objective of our investment activities is to preserve principal, maintain liquidity that is sufficient to meet cash needs and maximize total return without significantly increasing risk. To achieve this goal, we maintain our excess cash and cash equivalents in money market funds and marketable debt securities. We do not enter into investments for trading or speculative purposes and we hold no equity securities. We presently have no borrowings or lines of credit.

Specifically, as of September 30, 2025, we had cash, cash equivalents and short-term investments of approximately $28.8 million, which consist of primarily bank deposits, money market funds and U.S. government securities. All of our investments must satisfy high credit rating requirements at the time of purchase. Such interest-earning instruments carry a degree of interest rate risk, however, because our investments are rated highly and mostly short-term, we believe that our exposure to risk of loss due to interest rate changes is not significant.

Exchange Rate Sensitivity

Our royalty revenue, which is calculated in U.S. dollars, is based on sales in Japanese yen, so a 1% increase in the strength of the U.S. dollar against the yen would lead to a 1% reduction in royalty revenue and related accounts receivable. All our other revenue and substantially all of our expenses, assets and liabilities are denominated in U.S. dollars and, as a result, we have not experienced significant foreign exchange gains or losses recently and do not anticipate that foreign exchange gains or losses will be significant in the near future.

Item 4.  Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our principal executive officer and principal accounting and financial officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on such evaluation, our management has concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of September 30, 2025.

Changes in Internal Control over Financial Reporting

There was no material change in our internal control over financial reporting that occurred during the quarter ended September 30, 2025, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitations on Effectiveness of Controls

Our management, including our principal executive officer and principal accounting and financial officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within Vaxart have been detected.

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PART IIOTHER INFORMATION

Item 1.  Legal Proceedings

The information included in “Note 7. Commitments and Contingencies—(c)Litigation” to the Condensed Consolidated Financial Statements in Part I, Item 1 is incorporated by reference into this Item.

We may also from time to time be involved in legal proceedings arising in connection with our business. Based on information currently available, we believe that the amount, or range, of reasonably possible losses in connection with any pending actions against us in excess of established reserves, in the aggregate, is not material to our condensed consolidated financial condition or cash flows. However, any current or future dispute resolution or legal proceeding, regardless of the merits of any such proceeding, could result in substantial costs and a diversion of management’s attention and resources that are needed to run our business successfully, and could have a material adverse impact on our business, financial condition and results of operations.

Item 1A.  Risk Factors

You should consider the risks and uncertainties described under Item 1A of Part I of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which we filed with the Securities and Exchange Commission on March 20, 2025, together with all other information contained or incorporated by reference in this Quarterly Report on Form 10-Q, when evaluating our business and our prospects. There are no material changes to the risk factors set forth in Part I, Item 1A, in our Annual Report on Form 10-K for the year ended December 31, 2024, except as described below.

Currently, a significant portion of the funds to study our COVID vaccine candidate is expected to come from HHS BARDA. If HHS BARDA were to further reduce, eliminate, delay, or object to funding available to us under the 2024 ATI-RRPV Contract, this could have a significant, negative impact on our revenues and cash flows, and we may be forced to suspend or terminate the continued development of the product candidate or obtain alternative sources of funding.

In June 2024, we entered into the 2024 ATI-RRPV Contract with ATI, the Rapid Response Partnership Vehicle’s Consortium Management Firm funded by HHS BARDA. The 2024 ATI-RRPV Contract, as modified and amended to date, provides for a funding ceiling of approximately $460.7 million. In September 2025, ATI increased the total amount of funding available for payment to approximately $305.0 million.

We anticipate that a significant portion of the funding to further develop our COVID-19 vaccine candidate will come from the remaining amounts to be received under the 2024 ATI-RRPV Contract. The 2024 ATI-RRPV Contract provides that the government has the right to determine whether to fund the continued performance of the study after the initial funding. In February 2025, we received written notification directing the Company to stop work on the 2024 ATI-RRPV Contract, with the exception that we could continue efforts associated with the per protocol follow-up for the 400-participant cohort. Subsequently, in April 2025, the Company received written notification from ATI in the form of the Lift Notice that the stop work order had been lifted and that the Company may resume incurring costs, participating in meetings, and communicating with the Government and ATI concerning the project award. The Lift Notice required further discussion between the Company and HHS BARDA regarding costs, timelines, and regulatory pathway agreement. In May 2025, the Company received approval from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services to initiate dosing in the 10,000-participant portion of its ongoing Phase 2b clinical trial. The Company announced the first participant dosed in 10,000-participant portion of the trial later that month.

On August 5, 2025, the Company received written notification from ATI in the form of a stop work order directing the Company to stop work on screening and enrollment for the COVID-19 Phase 2b trial under the 2024 ATI-RRPV Contract as of the notification date. On October 8, 2025, the Company received a follow-up notice from ATI, which indicated that BARDA intends to conclusively delimit the project agreement to exclude work subject to the foregoing stop work order from the 2024 ATI-RRPV Contract. The Company may, however, continue efforts associated with the per protocol follow-up of all participants dosed as of the notification date in the study under the terms of the 2024 ATI-RRPV Contract. As of the August notification date, the Company had enrolled approximately half of the targeted number of participants for the study. The funding under the 2024 ATI-RRPV Contract is currently under review in light of the August 2025 stop work order and is likely to be reduced in line with the reduced enrollment of approximately 5,000 participants vs. the original planned enrollment of 10,000 participants in the main cohort of the Phase 2b study.

Even as we continue to receive funds under the 2024 ATI-RRPV Contract, the terms of the grant may unfavorably change, or the amount of funding may further decrease. If there is any government decision to discontinue funding under the 2024 ATI-RRPV Contract, our revenues and cash flows would be significantly and negatively impacted and we may be forced to seek alternative sources of funding, which may not be available on non-dilutive terms, terms favorable to us, or at all.

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Changes in the regulatory environment for vaccines could adversely impact our product development and commercialization efforts.

Recent developments in U.S. vaccine oversight, including increased involvement by the FDA Commissioner’s office in approval decisions and changes to the Advisory Committee on Immunization Practices (ACIP), may create additional uncertainty in the regulatory process. These changes could result in new or heightened requirements for clinical data, slower review timelines, or altered recommendations for use, any of which could adversely affect the timing, likelihood of approval, and market acceptance of our vaccine candidates.

Our common stock has been suspended from Nasdaq, and we have been notified our common stock will be delisted. There can therefore be no assurance that it will trade on a national exchange again***.***

Effective July 8, 2025, Nasdaq suspended trading in our common stock and subsequently informed the company on September 19, 2025 that the Company’s common stock will be delisted from The Nasdaq Capital Market due to the Company’s ongoing failure to comply with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2). Our common stock is currently quoted on the OTCQX under the ticker symbol “VXRT.” We can provide no assurance that our common stock will continue to trade on this market, whether broker-dealers will continue to provide public quotes for our common stock, and whether the trading volume of our common stock will be sufficient to provide for an efficient trading market in the future. Stocks trading in the OTC Markets generally have substantially less liquidity, hence, decreasing our ability to issue additional securities or obtain additional financing. The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the sale of certain securities, which are referred to as “covered securities.” If we are no longer listed on Nasdaq, our securities would not qualify as covered securities under the statute and we would be subject to regulation in each state in which we offer our securities.

We may not be able to retain coverage by securities or industry analysts because our common stock is not traded on a national securities exchange.

The trading in our common stock is influenced by independent research and reports that securities or industry analysts publish about us or our business from time to time. Because our common stock trades on the OTCQX Best Market rather than a national securities exchange, our exposure to media and coverage by securities and industry analysts may be limited. Further, if one or more of the analysts who cover us should downgrade our shares or change their opinion of our business prospects, our share price may be adversely impacted.

We may be unable to realize the potential benefits of our collaboration with Dynavax Technologies Corporation.

On November 4, 2025, we have entered into the License Agreement with Dynavax, pursuant to which we have granted Dynavax an exclusive, worldwide license to develop and commercialize our investigational oral vaccine candidate for COVID-19 based on our oral delivery platform for COVID Indications. Under the License Agreement, we have agreed to, among other things, continue to develop our oral pill COVID-19 vaccine candidate through completion of the ongoing Phase 2b clinical trial of such vaccine candidate. Following a planned for end-of-Phase 2 meeting (“EOP2 Meeting”) with the FDA, Dynavax will have the choice, in its sole discretion, to assume responsibility for the continued development of the vaccine candidate. If Dynavax elects to undertake the continued development of our oral pill COVID-19 vaccine candidate, then we will be entitled to receive from Dynavax a fee of $50 million, subject to the terms and conditions of the License Agreement. The License Agreement further contemplates specific milestone payments payable by Dynavax to us, subject to the terms and conditions of the License Agreement. If Dynavax does not elect to assume responsibility for such continued development of the vaccine candidate, then the License Agreement will terminate pursuant to its terms.

There can be no guarantee that the collaboration with Dynavax will be successful, and we may be unable to realize in full or in part the potential benefits of such collaboration if the results of the Phase 2b clinical trial and EOP2 Meeting are unfavorable or Dynavax does not elect to assume responsibility for the continued development of our oral pill COVID-19 vaccine candidate. Even if Dynavax elects to assume responsibility for such continued development, our collaboration with Dynavax may not result in the successful development or commercialization of products or product candidates in light of the following risks:

collaborators often have significant discretion in determining the efforts and resources that they will apply to the collaboration, and may not commit sufficient resources to the development, marketing or commercialization of the product or products that are subject to the collaboration;
collaborators may not perform their obligations as expected;
any such collaboration may significantly limit our share of potential future profits from the associated program, and may require us to relinquish potentially valuable rights to our current product candidates, potential products or proprietary technologies or grant licenses on terms that are not favorable to us;
collaborators may cease to devote resources to the development or commercialization of product candidates being jointly developed if the collaborators view such product candidates as competitive with their own products or product candidates;
disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the course of development, might cause delays or termination of the development or commercialization of product candidates, and might result in legal proceedings, which would be time consuming, distracting and expensive;
collaborators may be impacted by changes in their strategic focus or available funding, or business combinations involving them, which could cause them to divert resources away from the collaboration;
collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;
the collaborations may not result in us achieving revenues to justify such transactions; and
collaborations may be terminated and, if terminated, may result in a need for us to raise additional capital to pursue further development or commercialization of the applicable product candidate.

Item 2. **** Unregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3 . Defaults Upon Senior Securities

Not applicable.

Item 4 . Mine Safety Disclosure s

Not applicable.

Item 5 . Other Information

During the quarter ended September 30, 2025, no director or officer, as defined in Rule 16a-1(f), adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” each as defined in Item 408 of Regulation S-K.

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Item 6.  Exhibits

Incorporated by Reference
Exhibit Number Description of Document Schedule/Form File Number Exhibit Filing Date
3.1 Restated Certificate of Incorporation of Aviragen Therapeutics, Inc. Form 10-K 001-35285 3.1 September 13, 2016
3.2 Certificate of Amendment to Restated Certificate of Incorporation of Aviragen Therapeutics, Inc. Form 8-K 001-35285 3.1 February 20, 2018
3.3 Certificate of Amendment to Restated Certificate of Incorporation of Vaxart, Inc. Form 8-K 001-35285 3.2 February 20, 2018
3.4 Certificate of Amendment to Restated Certificate of Incorporation of Vaxart, Inc. Form 8-K 001-35285 3.1 April 24, 2019
3.5 Certificate of Amendment to Restated Certificate of Incorporation of Vaxart, Inc. Form 8-K 001-35285 3.1 June 9, 2020
3.6 Certificate of Amendment to Restated Certificate of Incorporation of Vaxart, Inc. Form 10-Q 001-35285 3.3 August 8, 2022
3.7 Amended and Restated Bylaws of Vaxart, Inc., effective as of October 18, 2023 Form 8-K 001-35285 3.1 October 23, 2023
3.8 Certificate of Amendment to Restated Certificate of Incorporation of Vaxart, Inc. Form 8-K 001-35285 3.1 June 13, 2024
10.1*^ Exclusive License and Collaboration Agreement, dated November 4, 2025, between Vaxart, Inc. and Dynavax Technologies Corporation.
10.2*# Securities Purchase Agreement, dated November 4, 2025, between Vaxart, Inc. and Dynavax Technologies Corporation.

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31.1 * Certification of Principal Executive Officer pursuant to Exchange Act Rule, 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2 * Certification of Principal Financial Officer pursuant to Exchange Act Rule, 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1 § Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS * Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File as 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)
* Filed herewith.
--- ---
§ In accordance with Item 601(b)(32)(ii) of Regulation S-K and SEC Release Nos. 33-8238 and 34-47986, Final Rule: Management’s Reports on Internal Control Over Financial Reporting and Certification of Disclosure in Exchange Act Periodic Reports, the certification furnished in Exhibit 32.1 hereto is deemed to accompany this Quarterly Report on Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Exchange Act. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent that the registrant specifically incorporates it by reference.
^ Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted as (i) the Company has determined the omitted information is not material and/or (ii) the Company customarily and actually treats the omitted information as private or confidential.
# Certain schedules and exhibits have been omitted in compliance with Regulation S-K Item 601(a)(5) or certain personal information has been redacted from this exhibit pursuant to Item 601(a)(6) of Regulation S-K. The Company agrees to furnish a copy of any omitted schedule or exhibit to the SEC upon its request.

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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.

VAXART, INC.
Dated: November 13, 2025 By:  /s/ STEVEN LO
Steven Lo
President and Chief Executive Officer
(Principal Executive Officer)
Dated: November 13, 2025 By:  /s/ JEROEN GRASMAN
Jeroen Grasman
Chief Financial Officer
(Principal Financial and Accounting Officer)

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ex_887368.htm

Exhibit 10.1

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT (I) IS NOT MATERIAL AND (II) IS OF THE TYPE THAT THE REGISTRANT CUSTOMARILY AND ACTUALLY TREATS AS PRIVATE OR CONFIDENTIAL.

Execution Version

EXCLUSIVE LICENSE AND COLLABORATION AGREEMENT

between

VAXART, INC.

and

DYNAVAX TECHNOLOGIES CORPORATION


EXCLUSIVE LICENSE AND COLLABORATION AGREEMENT

THIS EXCLUSIVE LICENSE AND COLLABORATION AGREEMENT (this “Agreement”), dated as of November 4, 2025 (the “Effective Date”), is entered into by and between VAXART, INC., a Delaware corporation (“Vaxart”), having an address of 170 Harbor Way, Suite 300, South San Francisco, California 94080, and DYNAVAX TECHNOLOGIES CORPORATION, a Delaware corporation (“Dynavax”), having an address of 2100 Powell Street, Suite 720, Emeryville, California 94608.  Vaxart and Dynavax are each sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

RECITALS

WHEREAS, Vaxart is engaged in the development of oral recombinant vaccines based on Vaxart’s VAAST® (Vector-Adjuvant-Antigen Standardized Technology) proprietary oral vaccine platform (the “Vaxart Platform”) and targeting a range of infectious diseases, and is developing, and possesses intellectual property rights and technology directed to, novel prophylactic vaccine candidates using the Vaxart Platform that target SARS-CoV-2, including its oral pill COVID-19 vaccine candidate VXA-CoV2-3.3 (as more fully defined below, the “Vaccine Candidate”);

WHEREAS, Dynavax has experience and expertise in the research, development, manufacture and commercialization of vaccine products; and

WHEREAS, Dynavax and Vaxart desire to enter into this Agreement, pursuant to which, among other things: (a) Vaxart will conduct and complete the ongoing Phase 2b clinical trial of the Vaccine Candidate, otherwise perform its obligations under its Project NextGen/BARDA award and related ATI-RRPV Base Agreement and Project Award Agreement, and conduct additional development and manufacturing activities related to the Vaccine Candidate; and (b) Vaxart will grant to Dynavax an exclusive, worldwide license under certain Vaxart intellectual property rights and technology to develop and commercialize Compounds and Products; in each case, upon the terms and subject to the conditions set forth herein.

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, the receipt and sufficiency of which are hereby acknowledged, Vaxart and Dynavax hereby agree as follows:

1.         Definitions

The terms in this Agreement with initial letters capitalized, whether used in the singular or the plural, shall have the meanings set forth below or, if not listed below, the meanings designated where first used in this Agreement.

1.1         “Accounting Standards” shall mean (a) U.S. generally accepted accounting principles or (b) International Financial Reporting Standards; in each case, as applicable, consistently applied throughout the organization of a particular Entity and its Affiliates.

1


1.2         “Acquirer” shall mean any Third Party that is a counterparty in any Change of Control transaction and any of such Third Party’s Affiliates as of immediately prior to the consummation of such Change of Control transaction.

1.3         “Act” shall mean, as applicable, the U.S. Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et seq., or the Public Health Service Act, 42 U.S.C. §§ 262 et seq.

1.4         “Affiliate” shall mean, with respect to any Entity (including a Party), any other Entity controlled by, controlling, or under common control with such Entity at the time of the determination of affiliation. For the purposes of this definition, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to an Entity shall mean: (a) direct or indirect ownership of more than 50% of the voting securities, capital stock or other equity interests of such Entity; or (b) possession, directly or indirectly, of the power to direct the management and policies of such Entity, whether through the ownership of voting securities, by contract or otherwise.

1.5         “Anti-Corruption Laws” shall mean the U.S. Foreign Corrupt Practices Act (15 U.S.C. §§ 78dd-1, et seq.), the Organization for Economic Co-operation and Development (OECD) Convention on combating bribery of foreign public officials in international business transactions, and any other applicable anti-corruption laws.

1.6         “Applicable Law” shall mean all applicable laws, statutes, code, ordinances, regulations, rules, enforceable guidelines, injunctions, judgments, orders, writs, stipulations, awards, arbitration awards, decrees, constitutions, treaties and other pronouncements having the effect of law, in each case, enacted, promulgated, issued, enforced or entered by any Governmental Authority applicable to any Party or such Party’s business, properties or assets, including, as applicable, the Act, Prescription Drug Marketing Act of 1987 (21 U.S.C. §§ 331, 333, 353, 381), the Generic Drug Enforcement Act of 1992 (21 U.S.C. § 335(a) et seq.), the U.S. Patent Act (35 U.S.C. § 1 et seq.), the Federal False Claims Act (31 U.S.C. § 3729 et seq.), the Anti-Kickback Statute (42 U.S.C. § 1320a-7b et seq.), and Anti-Corruption Laws.

1.7         “ASPR-BARDA Contract” shall mean the ASPR-BARDA Award/Contract dated January 12, 2024, between Vaxart and the U.S. Government through the Department of Health and Human Services (Contract 75A50124C00002).

1.8         “ATI-RRPV Base Agreement” shall mean the agreement between Vaxart and Advanced Technology International, dated as of May 6, 2024, and designated as agreement no. 2024-606.

1.9         “Average Net Selling Price” shall mean, on a Product-by-Product (or Other Active-by-Other Active, as applicable) and country-by-country basis in the Territory, the aggregate Net Sales for such Product (or Other Active, as applicable) in such country divided by the number of units of such Product (or Other Active, as applicable) sold in such country during the applicable reporting period, expressed in the applicable local currency.

1.10         “BARDA Obligations” shall mean Vaxart’s obligations under its Project NextGen/BARDA award and related ATI-RRPV Base Agreement and Project Award Agreement related to the Vaccine Candidate.

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1.11         “Biosimilar Product” shall mean, with respect to a Product and on a country-by-country basis in the Territory, a product that (a) is marketed for sale in such country by a Third Party (not directly or indirectly licensed, supplied or otherwise authorized by Dynavax or any of its Affiliates or Sublicensees); and (b) has received Marketing Approval in such country by means of a procedure that relies in whole or in part on the safety and efficacy data contained in the BLA or MAA for such Product submitted by or on behalf of Dynavax or its Affiliate or Sublicensee in such country to establish bioequivalence to such Product.

1.12         “Business Day” shall mean a day other than Saturday, Sunday or any other day on which banking institutions in San Francisco, California, USA, are authorized or required to be closed for business.

1.13         “Calendar Quarter” shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31, during the Term, or the applicable part thereof during the first or last calendar quarter of the Term.

1.14         “Calendar Year” shall mean any calendar year ending on December 31, or the applicable part thereof during the first or last year of the Term.

1.15         “Change of Control” shall mean, with respect to a Party, (a) a merger or consolidation of such Party with a Third Party that results in the voting securities of such Party outstanding immediately prior thereto, or any securities into which such voting securities have been converted or exchanged, ceasing to represent at least 50% of the combined voting power of the surviving entity or the parent of the surviving entity immediately after such merger or consolidation; (b) a transaction or series of related transactions in which a Third Party, together with its Affiliates, becomes the beneficial owner of 50% or more of the combined voting power of the outstanding securities of such Party; or (c) the sale or other transfer to a Third Party of all or substantially all of such Party’s assets or business to which the subject matter of this Agreement relates.

1.16         “China” shall mean the People’s Republic of China, excluding, for purposes of this Agreement, Hong Kong, Macau, and Taiwan.

1.17         “Clinical Trial” shall mean any study in which human subjects are dosed or treated with a pharmaceutical or biological product, whether approved or investigational.

1.18         “CMC” shall mean chemistry, manufacturing and controls.

1.19         “CMC Development” shall mean Development activities related to the CMC of drug substance and drug product intended to ensure the proper identification, quality, purity and strength of the drug, including test method development and stability testing, process development, drug substance development, delivery system development, technology transfer, process validation, process scale-up, formulation development, quality assurance and quality control development.

1.20         “CMO” shall mean a Third Party contract manufacturing organization.

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1.21         “Combination Product” shall mean (a) a product that contains a Compound and at least one Other Active in the same therapeutic preparation or formulation, or (b) a Product co‑packaged with at least one Other Active, sold and invoiced as a single unit for a single price in a single package or container. For clarity, the presence of any drug delivery vehicle or excipient in either of the foregoing (clause (a) or (b)) in itself shall not be deemed to create a Combination Product.

1.22         “Commercialization” shall mean any activities directed to marketing, promoting, detailing, distributing, importing, exporting, using, offering to sell or selling a drug or biologic product, including activities directed to obtaining Pricing and Reimbursement Approvals, conducting pre- and post-Regulatory Approval activities and launching and promoting such drug or biologic products in each country, as applicable. When used as a verb, “Commercialize” means to engage in Commercialization activities.

1.23         “Commercialization Approval” shall mean, with respect to a Product and any country or regulatory jurisdiction, receipt of both: (a) Marketing Approval for such Product from the applicable Regulatory Authority in such country or regulatory jurisdiction; and (b) any pricing and reimbursement approvals that are reasonably necessary for Dynavax or its Affiliate or Sublicensee to Commercialize such Product in such country (“Pricing and Reimbursement Approvals”), even if such approvals are not legally required for Dynavax to conduct a launch of such Product in such country.

1.24      **** “Commercially Reasonable Efforts” shall mean, with respect to the efforts to be expended by a Party with respect to any objective, those reasonable, diligent, good faith efforts to accomplish such objective that a similarly situated pharmaceutical or biotechnology company in the exercise of its reasonable business discretion would normally use to accomplish a similar objective under similar circumstances.  With respect to any objective relating to the Development or Commercialization of a Product by a Party, “Commercially Reasonable Efforts” shall mean those efforts and resources normally used by a similarly situated pharmaceutical or biotechnology company in the exercise of its reasonable business discretion with respect to a product owned or controlled by such Party, or to which such Party has similar rights, which product has similar product characteristics, is of similar market potential and is at a similar stage in its development or life as is such Product, taking into account all relevant scientific, technical, legal, clinical, operational, economic and commercial factors that may affect the Development or Commercialization of a product, including (as applicable): actual and potential issues of safety, efficacy or stability; expected and actual product profile; stage of development or life cycle status; actual and projected Development, regulatory, Manufacturing and Commercialization costs; timelines and budgets; any issues regarding the ability to Manufacture or have Manufactured the product; the likelihood of and timing for obtaining Regulatory Approval or Commercialization Approval; approved labeling or anticipated labeling; the then-current competitive environment and the likely competitive environment at the time of projected entry into the market, including the expected and actual competitiveness of alternative products in the marketplace; past performance of the product or similar products; present and future market potential; existing or projected pricing, sales, reimbursement and profitability; and expected and actual proprietary position, strength and duration of patent protection and anticipated regulatory or other exclusivity as such company would normally use to accomplish a similar objective under similar circumstances.  To the extent that [***].

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1.25         **** “Competing Product” shall mean any [***] in the Field.

1.26         **** “Competing Program” shall mean activities in furtherance of the [***] of a Competing Product.

1.27      **** “Compound” shall mean any vaccine, including any vaccine candidate, using the Vaxart Platform that is intended for use, or designed for potential use, or under investigation for use, in each case, in the Field, including the Vaccine Candidate.  For clarity, a Compound [***].

1.28         “Confidential Information” of a Party shall mean any confidential or proprietary information provided orally, visually, in writing or other form by or on behalf of such Party (or an Affiliate or representative of such Party) to the other Party (or to an Affiliate or representative of such Party) in connection with this Agreement or related to the scientific, regulatory or business affairs or other activities of either Party.

1.29      “Control” (including, with correlative meanings, “Controls” or “Controlled by”) shall mean, with respect to any Know-How, Patent Right, other intellectual property right, material or Confidential Information, possession by a Party (whether by ownership or license or otherwise, other than pursuant to a license or other rights granted to such Party under this Agreement), directly or through an Affiliate of such Party, of the ability to transfer or disclose, or grant a license or sublicense under, such right, material or Confidential Information, as applicable, as provided for herein without violating the terms of any agreement or binding arrangement with any Third Party; provided, however, that any Know-How, Patent Right, other intellectual property right, material or Confidential Information that is owned or licensed by an Acquirer of Vaxart or any Affiliate of such Acquirer (excluding any Affiliate that was an Affiliate of Vaxart prior to a Change of Control and became an Affiliate of such Acquirer as a result of such Change of Control) shall not be deemed to be Controlled by Vaxart for purposes of this Agreement, except to the extent, and only to the extent that, such Know-How, Patent Right, other intellectual property right, material or Confidential Information (i) is actually used by Vaxart, the Acquirer or any of their respective Affiliates in the performance of Vaxart’s obligations under this Agreement with respect to any Compound or Product following the consummation of the Change of Control of Vaxart, (ii) is made, conceived or reduced to practice by the Acquirer or any such Affiliates through the use of the Vaxart Technology or Joint Technology following the consummation of the Change of Control of Vaxart or (iii) was transferred, disclosed or otherwise licensed or sublicensed to Vaxart prior to the consummation of the Change of Control of Vaxart.

1.30         “Cover(s)” (including, with correlative meanings, “Covering” and “Covered”) shall mean, with respect to a Patent Right and a product, invention or technology, that, in the absence of ownership of or a license under such Patent Right, the manufacture, use, sale, offer for sale or importation of such product or the practice of such invention or technology would Infringe one or more claims of such Patent Right.

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1.31         “CRO” shall mean a Third Party contract research organization.

1.32         “Data” shall mean any and all results of research, preclinical and non-clinical studies, including in vitro, in vivo, and ex vivo studies, Clinical Trials and other testing of a Compound or Product, and any and all other data generated by or on behalf of a Party related to the Development, Manufacture or Commercialization of a Compound or Product, including biological, chemical, pharmacological, toxicological, safety, pharmacokinetic, clinical, CMC, analytical, quality control, mechanical, software, electronic and other data, results and descriptions.

1.33         “Development” shall mean all research and non-clinical and clinical drug development activities and processes, including toxicology, pharmacology, project management and other non-clinical efforts, formulation development, delivery system development, statistical analysis, Manufacturing development, the performance of Clinical Trials (including the Manufacturing of products for use in Clinical Trials), or other activities reasonably necessary in order to obtain and maintain Marketing Approval of a pharmaceutical or biologic product. When used as a verb, “Develop” shall mean to engage in Development activities.

1.34         “Development Program Activities” shall mean the Development and Manufacturing activities to be conducted by or on behalf of Vaxart under the Development Program.

1.35         “Development Program Term” shall mean the period beginning on the Effective Date and, subject to earlier termination of this Agreement in accordance with Article 12, ending upon the completion of all Development Program Activities and delivery by Vaxart to Dynavax of the deliverables specified in the Development Plan and of the EOP2 Data Package. For clarity, the Parties acknowledge that (a) not all Development Program Activities will necessarily have been completed as of the date of delivery by Vaxart to Dynavax of the EOP2 Data Package or Dynavax’s payment to Vaxart of the Dynavax Election Payment, and (b) subject to earlier termination of this Agreement in accordance with Article 12, the Development Program Term will continue after delivery of the EOP2 Data Package and Dynavax’s payment to Vaxart of the Dynavax Election Payment until completion of all Development Program Activities.

1.36         “Dynavax Housemark” shall mean the corporate name or logo of Dynavax or any of its Affiliates, together with any derivative marks of such name or logo.

1.37         “Dynavax Invention” shall mean any Invention made solely by one or more employees, consultants or contractors of Dynavax or its Affiliates.

1.38         “Dynavax Know-How” shall mean Know-How generated by or on behalf of Dynavax or any of its Affiliates in the exercise of the License and Controlled by Dynavax or its Affiliates during the Term that is necessary for, or actually used by Dynavax or any of its Affiliates or Sublicensees in, the Development, Manufacture or Commercialization of any Compound or Product; but excluding any Dynavax Patent and Joint Technology.

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1.39         “Dynavax Patent” shall mean any Patent Right Controlled by Dynavax or any Affiliate of Dynavax as of the Effective Date or during the Term that Covers a Dynavax Invention that is necessary for, or actually used by or on behalf of Dynavax or any of its Affiliates or Sublicensees in, the Development, Manufacture or Commercialization of a Compound or Product; but excluding any Joint Patent.

1.40         “Dynavax Technology” shall mean the Dynavax Know-How and the Dynavax Patents.

1.41         “EMA” shall mean the European Medicines Agency or any successor agency thereto in the EU having substantially the same function.

1.42         “Entity” shall mean any corporation, general partnership, limited partnership, limited liability partnership, joint venture, estate, trust, company (including any limited liability company or joint stock company), firm or other enterprise, association, organization or entity.

1.43         “EU” shall mean the European Union, as its membership may be constituted from time to time, and any successor thereto.

1.44         “FDA” shall mean the U.S. Food and Drug Administration or any successor agency thereto in the U.S. having substantially the same function.

1.45         “Field” shall mean the prevention and treatment of any or all of: (a) SARS-CoV-2 infection; (b) the respiratory illness caused by SARS-CoV-2 infection, i.e., COVID‑19; (c) the chronic, systemic condition commonly referred to as “Long COVID” that may occur after SARS-CoV-2 infection, including any or all of the post-acute sequelae of SARS-CoV-2 infection and/or COVID‑19; (d) SARS coronavirus infection; (e) the respiratory illness caused by SARS coronavirus infection, i.e., SARS-CoV; (f) MERS coronavirus infection; (g) the respiratory illness caused by MERS coronavirus infection, i.e., Middle East respiratory syndrome, or MERS; (f) infection by any coronavirus other than SARS-CoV-2, SARS coronavirus and MERS coronavirus; and (g) any respiratory illness caused by any such other coronavirus infection. For purposes of this Section 1.45, references to SARS-CoV-2, SARS coronavirus, or MERS coronavirus shall include all variants of SARS-CoV-2, SARS coronavirus, or MERS coronavirus, respectively.

1.46        **** “Firewall Period” shall mean (a) in respect of an Acquired Competing Product, the period commencing on the date of the consummation of applicable transaction in which Vaxart acquires such Acquired Competing Product and ending on the date that is [***] after the date of the consummation of such acquisition, and (b) in respect of a Change of Control of Vaxart, the period commencing on the date of the consummation of a Change of Control of Vaxart and ending on the expiration or termination of the Term.

1.47         “Firewalls” shall mean reasonable walls and screens (whether technical, physical or procedural) established by Vaxart and any Acquirer of Vaxart, or by Vaxart and any Acquired Entity, as applicable: (a) to ensure that no non-public information or materials (such as lab notebooks, document management systems or other documented or memorialized non-public Know-How) or other non-personnel resources relating to Compounds, Products or non-public Vaxart Know-How (but excluding any Vaxart Know-How relating to the Vaxart Platform) are accessible by personnel of such Acquirer or such Acquired Entity during the applicable Firewall Period; and (b) to ensure that no Confidential Information of Dynavax is accessible by personnel of the Acquirer or Acquired Entity, in each case (clauses (a) and (b)), excluding, solely with respect to an Acquirer of Vaxart, executive management personnel, solely as necessary to review high level information to facilitate the making of managerial decisions across programs.

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1.48         “First Commercial Sale” shall mean, with respect to a Product in a country, the first commercial sale in an arm’s-length transaction of such Product to a Third Party or Governmental Authority in such country after Marketing Approval of such Product has been granted, or such marketing and sale is otherwise permitted, by the Regulatory Authority of such country. Sales for Clinical Trial purposes, early access programs, named patient, registration samples or compassionate use shall not constitute a First Commercial Sale. In addition, sales of a Product by and between Dynavax and its Affiliates and Sublicensees for eventual resale to a Third Party shall not constitute a “First Commercial Sale.”

1.49         “Good Clinical Practice” or “GCP” shall mean the current standards for good clinical practice and clinical trials of pharmaceuticals, as set forth in the FDA’s Good Clinical Practice regulations and in the ICH guidelines, in each case, as amended from time to time, and such standards of good clinical practice as are required by the EU and other organizations and Governmental Authorities in countries other than the U.S. in which a pharmaceutical product is intended to be sold, to the extent such standards are not less stringent than U.S. Good Clinical Practice.

1.50         “Good Laboratory Practice” or “GLP” shall mean the current standards for laboratory activities for pharmaceuticals, as set forth in the FDA’s Good Laboratory Practice regulations or the Good Laboratory Practice principles of the Organization for Economic Co-Operation and Development, as amended from time to time, and such standards of good laboratory practice as are required by the EU and other organizations and Governmental Authorities in countries in which a pharmaceutical product is intended to be sold, to the extent such standards are not less stringent than U.S. Good Laboratory Practice.

1.51         “Good Manufacturing Practice” or “GMP” shall mean the part of quality assurance that ensures that pharmaceutical products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use as defined in 21 C.F.R. § 210, 211 and 610, European Directive 2003/94/EC, Eudralex 4, Annex 16, and applicable U.S., EU, Canadian and ICH guidance or equivalent laws in other jurisdictions.

1.52         “Governmental Authority” shall mean any applicable government authority, court, tribunal, arbitrator, panel, agency, department, legislative body, commission or other instrumentality of (a) any government of any country or territory, (b) any nation, state, province, county, city or other political subdivision thereof or (c) any supranational body.

1.53         **** “High Risk Market” shall mean [***].

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1.54         “IND” shall mean (a) any Investigational New Drug Application, as defined in the U.S. Federal Food, Drug and Cosmetics Act, filed with the FDA pursuant to Part 312 of Title 21 of the U.S. Code of Federal Regulations, including any amendments thereto; or (b) any comparable filing(s) outside the U.S. (such as a clinical trial authorization in the EU) necessary to commence or conduct Clinical Trials, including any amendments thereto.

1.55         “Infringe” (including, with correlative meanings, “Infringed” or “Infringement”) shall mean any infringement as determined by Applicable Law (subject to the immediately following sentence), including direct infringement, contributory infringement or any inducement **** to infringe. However, in determining whether a claim of a pending patent application would be “Infringed,” such claim shall be treated as if issued as then currently being prosecuted.

1.56         “Insolvency Proceeding” shall mean (a) any voluntary case or proceeding commenced by any Person under any state, federal or foreign law for, or any agreement of such Person to, the entry of an order for relief under the Bankruptcy Code of the United States of America, or any other insolvency, debtor relief or debt adjustment law, (b) any involuntary case or proceeding commenced against a Person under any state, federal or foreign law for the entry of an order for relief under the Bankruptcy Code of the United States of America, or any other insolvency, debtor relief or debt adjustment law, and such involuntary case or proceeding is not dismissed within 90 days after the filing thereof, (c) the appointment of a receiver, trustee, liquidator, administrator, conservator or other custodian for a Person or any part of its property or assets, or (d) the dissolution or liquidation of a Person, or an assignment or trust of a Person or any part of its property or assets for the benefit of creditors.

1.57         “Invention” shall mean any invention, whether or not patented, that is made, conceived, generated or reduced to practice, in whole or in part, by or on behalf of either Party or jointly by or on behalf of the Parties in the course or as a result of the conduct of activities under this Agreement, including the Development Program Activities and the practice of any license granted under this Agreement.

1.58         “Investment Agreements” shall mean: (a) that certain Securities Purchase Agreement between Vaxart and Dynavax dated as of the Effective Date (the “Securities Purchase Agreement”); and (b) the “Transaction Documents” (as such term is defined in the Securities Purchase Agreement).

1.59         “Joint Invention” shall mean any Invention made jointly by, on the one hand, one or more employees, consultants or contractors of Vaxart or any Affiliate of Vaxart, and, on the other hand, one or more employees, consultants or contractors of Dynavax or any of its Affiliates.

1.60         “Joint Patent” shall mean any Patent Right that Covers a Joint Invention.

1.61         “Joint Technology” shall mean Joint Inventions and Joint Patents.

1.62         “Know-How” shall mean commercial, technical, scientific and other information and know-how, including: (a) biological, chemical, pharmacological, toxicological, clinical, nonclinical, preclinical, manufacturing, safety, analytical, quality control and clinical Data; (b) assays; (c) trade secrets; (d) methods; (e) techniques, skills, instructions and formulae; (f) processes and practices; (g) procedures; (h) specifications; (i) sourcing information and (j) inventions; in each case (clauses (a)-(j)), that are not generally known to the public.

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1.63         **** “Major European Countries” shall mean the following [***] (without regard to whether or not any of the foregoing is an EU member state at any given time).

1.64       “Manufacturing” shall mean any activities directed to producing, manufacturing, processing, sourcing, filling, finishing, packaging, labeling, quality assurance testing and release, shipping and storage of a pharmaceutical or biologic product. When used as a verb, “Manufacture” shall mean to engage in Manufacturing activities.

1.65         “Marketing Approval” shall mean approval of a Marketing Approval Application by the applicable Regulatory Authority.

1.66         “Marketing Approval Application” shall mean: (a) a Biologics License Application submitted to the FDA pursuant to Section 351(a) of the Public Health Service Act (“BLA”) or a New Drug Application (as more fully defined in 21 CFR 314.5, et seq.) filed with the FDA, or any successor application thereto in the U.S. (“NDA”); (b) an application for authorization to market or sell a pharmaceutical or biological product submitted to a Regulatory Authority in any country or jurisdiction other than the U.S., including, with respect to the EU, a marketing authorization application filed with the EMA pursuant to the Centralized Approval Procedure or with the applicable Regulatory Authority of a country in the European Economic Area with respect to the decentralized procedure, mutual recognition or any national approval procedure (“MAA”); or (c) with respect to any product for which a BLA, NDA or MAA has been approved by the applicable Regulatory Authority, an application to supplement or amend such BLA, NDA or MAA to expand the approved label for such pharmaceutical or biological product.

1.67         “Material Safety Issue” shall mean the occurrence of any significant safety-related event, incident or circumstance with respect to a Compound or Product that leads a Party to reasonably determine that the continued use of such Compound or Product by patients may result in patients being exposed to a product for which the risks outweigh the benefits. Examples of Material Safety Issues include the issuance of a clinical hold order (or similar requirement or recommendation) by a Regulatory Authority, where the clinical hold is not resolvable in the ordinary course, or an IRB/EC requirement or recommendation to terminate or suspend a Clinical Trial.

1.68         **** “MNDA” shall mean that certain Mutual Non-Disclosure Agreement between Vaxart and Dynavax dated [***].

1.69      “Net Sales” shall mean, with respect to a Product, the gross amounts invoiced on sales of such Product by Dynavax or its Affiliates or Sublicensees (each, a “Selling Entity”) to a Third Party that is not a Sublicensee in arm’s-length transactions, less the following deductions, determined in accordance with the Selling Entity’s Accounting Standards and standard internal policies and procedures, in each case, consistently applied throughout such Selling Entity to calculate revenue for financial reporting purposes, to the extent actually incurred, allowed, paid, accrued or specifically allocated to sales of such Product:

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(a)        [***];

(b)        **** [***];

(c)        **** [***];

(d)        **** [***];

(e)        **** [***];

(f)        **** [***]; and

(g)        **** [***].

All aforementioned deductions shall only be allowable to the extent they are commercially reasonable, and shall be determined, on a country-by-country basis, as incurred in the ordinary course of business in type and amount consistent with Dynavax’s, its Affiliate’s or Sublicensee’s (as the case may be) business practices consistently applied across its product lines and its Accounting Standards, consistently applied, and verifiable. All such discounts, allowances, credits, rebates and other deductions shall be fairly and equitably allocated to such Product and other products of Dynavax and its Affiliates and Sublicensees such that such Product does not bear a disproportionate portion of such deductions. In no event will any particular amount identified above be deducted more than once in calculating Net Sales.

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Sales of a Product by and between Dynavax and its Affiliates and Sublicensees for eventual resale to Third Parties are not sales to Third Parties and shall be excluded from Net Sales calculations.

In the event that a Product is sold as part of a Combination Product in a country, the Net Sales with respect to the Combination Product in such country (for all financial terms pursuant to Article 7) shall be determined by multiplying the Net Sales amount for the Combination Product during the applicable reporting period, calculated as set forth above, by [***].  If the Other Active(s) in the Combination Product is not sold separately in such country during the applicable reporting period, Net Sales shall be calculated by multiplying actual Net Sales of such Combination Product by [***].  If neither the Product nor the Other Active(s) were sold separately in such country during the applicable reporting period, then the respective Average Net Selling Prices during the most recent reporting period in which sales of both occurred in the same country as the Combination Product shall be used.  In the event that the Average Net Selling Price of the Product is not available in a given country for any reporting period, then [***].

1.70         “Other Active” shall mean any active pharmaceutical ingredient that is not a Compound or a product containing any such active pharmaceutical ingredient (and not containing a Compound). For clarity, drug delivery vehicles and excipients are hereby deemed not to be “Other Actives.”

1.71         “Patent Rights” shall mean any and all (a) patents, (b) pending patent applications, including all provisional applications, substitutions, continuations, continuations-in-part, divisions and renewals, and all patents granted thereon, (c) all patents-of-addition, reissues, reexaminations and extensions, restorations or adjustments by existing or future extension, restoration or adjustment mechanisms, including supplementary protection certificates or the equivalent thereof, (d) inventor’s certificates, (e) other forms of government-issued right substantially similar to any of the foregoing, and (f) all U.S. and foreign counterparts of any of the foregoing.

1.72         “Person” shall mean any natural person or Entity.

1.73         “Phase 2b Trial” shall mean the Clinical Trial of the Vaccine Candidate described in Vaxart Clinical Protocol No. NCT 06672055, titled “A Study to evaluate VXA-COV2-3.3 COVID-19 Vaccine against currently approved/authorized mRNA COVID-19 Injectable Booster Vaccine in Adults Previously Immunized against COVID-19 Infection,” as amended from time to time in accordance with this Agreement.^^

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1.74         “Phase 2b Trial Completion Date” shall mean the date of database lock for the Phase 2b Trial.

1.75         “Product” shall mean any product comprising or containing a Compound, in any and all forms, presentations, delivery systems, dosage forms and strengths, and formulations. For the avoidance of doubt, all pharmaceutical preparations containing the same Compound, regardless of the presentation, formulation, and method of dosing thereof, shall constitute the same Product.

1.76         “Product Domain Names” shall mean any and all domain names registered for use in association solely with a Product and the Product Trademarks.

1.77         “Product Trademark” shall mean any Trademark used to Commercialize a Product, but excluding any Dynavax Housemark.

1.78         “Project Award Agreement” shall mean the award agreement between Vaxart and Advanced Technology International, dated as of June 13, 2024, and designated as agreement No. RRPV-24-04-NGVx-003, including all amendments, modifications, revisions and supplements thereto.

1.79         “Regulatory Approval” shall mean, with respect to any product in any jurisdiction, any and all approvals (including INDs, Marketing Approvals and Commercialization Approvals), licenses (including import licenses), registrations and authorizations from any Regulatory Authority that are required under Applicable Law or reasonably necessary for the Development, Manufacture or Commercialization of such product in such jurisdiction for one or more uses, and all amendments and supplements thereto.

1.80         “Regulatory Authority” shall mean any Governmental Authority, including the FDA and EMA, that has authority over the Development, Manufacture or Commercialization of pharmaceutical or biological products in a given jurisdiction in the Territory.

1.81         “Regulatory Documentation” shall mean: (a) all applications for Regulatory Approval (including Marketing Approval Applications); (b) all Regulatory Approvals, including INDs and Marketing Approvals; (c) all supporting documents created for, referenced in, submitted to or received from an applicable Regulatory Authority relating to any of the applications or Regulatory Approvals described in clauses (a) and (b), including drug master files (or any equivalent thereof outside the U.S.), annual reports, regulatory drug lists, advertising and promotion documents shared with Regulatory Authorities, adverse event files, complaint files and Manufacturing records; and (d) all correspondence made to, made with or received from any Regulatory Authority (including written and electronic mail correspondence and minutes from meetings, discussions or conferences (whether in person or by audio conference or videoconference)).

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1.82         “Regulatory Exclusivity” shall mean any exclusive marketing rights or data protection or other exclusivity rights conferred by any Regulatory Authority with respect to a pharmaceutical or biological product that prevent such Regulatory Authority from granting any Regulatory Approval of a Third Party product that has a composition that is the same as or substantially identical to the composition of such pharmaceutical or biological product, including orphan drug exclusivity, pediatric exclusivity, rights conferred in the U.S. under Section 351 of the Public Health Service Act, 42 U.S.C. § 262, the Drug Price Competition and Patent Term Restoration Act (21 U.S.C. § 355), the PPACA or in the EU under Directive 2001/83/EC and Regulation (EC) No. 1901/2006 or rights similar thereto in other countries or regulatory jurisdictions. If a Regulatory Authority confers more than one type of exclusivity with respect to a pharmaceutical or biological product in a country or jurisdiction (e.g., the FDA grants both biologic drug reference product exclusivity and pediatric exclusivity with respect to such biological product), “Regulatory Exclusivity” will be deemed to apply to such pharmaceutical or biological product in such country or jurisdiction so long as any exclusivity granted to such pharmaceutical or biological product prevents such Regulatory Authority from granting any regulatory approval of a Third Party product that is a Biosimilar Product.

1.83         “Right of Reference” shall mean: (a) in the U.S., a “right of reference or use,” as such term is defined in 21 C.F.R. 314.3(b); or (b) in any other country or jurisdiction, the equivalent authority to rely upon, and otherwise use, an investigation for the purpose of filing, and conducting a Clinical Trial under, an IND, or obtaining approval of a Marketing Approval Application or Regulatory Approval, including the ability to make available the underlying raw data from the investigation for audit by the applicable Regulatory Authority in such country or other jurisdiction, if necessary.

1.84         “Subcommittee” shall mean the JMC or any other subcommittee established by the JSC pursuant to Section 3.2.

1.85         “Sublicense” shall mean (a) a sublicense under the License or any portion thereof, or (b) a right to market, promote and sell Product in the Field in the Territory.

1.86         “Sublicensee” shall mean (a) any Third Party to which Dynavax (or its Affiliate) grants a Sublicense, or (b) another Third Party to which a Third Party described in the preceding clause (a) grants a further Sublicense.

1.87         “Tax” or “Taxes” shall mean any present or future taxes, levies, imposts, duties, charges, assessments or fees of any nature (including any interest thereon).

1.88         “Territory” shall mean the entire world.

1.89         “Third Party” shall mean any Person other than a Party or any of its Affiliates.

1.90         “Trademark” shall mean any word, name, symbol, color, designation, or device or any combination thereof, whether registered or unregistered, including any trademark, trade dress, service mark, service name, brand mark, trade name, brand name, logo or business symbol.

1.91         “U.S.” shall mean the United States of America, including its territories and possessions.

1.92         “U.S. Dollars,” “US$,” or “$” shall mean legal tender in the U.S.

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1.93         “Vaccine Candidate” shall mean that certain novel oral pill COVID-19 vaccine candidate using the Vaxart Platform referred to by Vaxart as VXA-CoV2-3.3 that is the investigational new drug described in the Vaccine Candidate IND.

1.94         “Vaccine Candidate IND” shall mean U.S. IND No. 27602.

1.95         “Valid Claim” shall mean a claim of an issued, unexpired patent that has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not taken within the time allowed for appeal, and that has not been disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise.

1.96         “Vaxart IND” shall mean any IND filed with the FDA or any other Regulatory Authority for any Compound, including the Vaccine Candidate, that is held in the name of Vaxart or any of its Affiliates as of the Effective Date or at any time on or before Dynavax’s payment to Vaxart of the Dynavax Election Payment, including the Vaccine Candidate IND.

1.97         “Vaxart Invention” shall mean any Invention made solely by one or more employees, consultants or contractors of Vaxart or any Affiliate of Vaxart.

1.98         “Vaxart Know-How” shall mean Know-How Controlled by Vaxart or any Affiliate of Vaxart as of the Effective Date or during the Term that is necessary or useful for the Development, Manufacture, or Commercialization of a Compound or Product, including any such Know-How related to the use of the Vaxart Platform in a Compound; but excluding any Vaxart Patents and Joint Technology.

1.99         “Vaxart Patent” shall mean any Patent Right Controlled by Vaxart or any Affiliate of Vaxart as of the Effective Date or during the Term that Covers any invention (including any Vaxart Invention) that is necessary or useful for the Development, Manufacture, or Commercialization of a Compound or Product, including any such invention directed to the use of the Vaxart Platform in a Compound. The Vaxart Patents as of the Effective Date include the patents and patent applications set forth on Exhibit A hereto.

1.100       **** “Vaxart Product-Specific Patents” shall mean all Vaxart Patents, [***].  The Vaxart Product-Specific Patents as of the Effective Date include the patents and patent applications set forth on Exhibit B.

1.101         “Vaxart Technology” shall mean the Vaxart Know-How and the Vaxart Patents. For clarity, the Vaxart Technology shall include the Vaxart Platform.

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1.102         Additional Definitions. The definition of each of the following terms is set forth in the section of this Agreement indicated below:

Defined Term Section
AAA 14.3(a)
AAA Rules 14.3(a)
[***] 6.2(a)
[***] 6.2(b)
[***] 6.2(b)
Agreement Preamble
Alliance Manager 3.5
Audit 4.5(f)(i)
Audit Observation 4.5(f)(iii)
Audited Site 4.5(f)(i)
Biosimilar Application 9.3(a)
BLA 1.66
CAPA 4.5(f)(iii)
Claim 13.1
Development Plan 4.2(a)
Development Program 4.1
Disclosing Party 10.1
Disputes 14.1
Dynavax Preamble
Dynavax Election Payment 7.3(b)
Dynavax Indemnitee 13.2
Election Period 4.7(b)
[***] 4.7(b)
Election to Proceed Notice 4.7(b)
Enforcing Party 9.3(e)
EOP2 Data Package 4.7(a)
EOP2 Meeting 2.3(a)(i)
[***] 7.3(a)
Existing Vaxart Product-Specific Patents 11.2(b)
Existing Vaxart Patents 11.2(a)
Indemnified Party 13.3
Indemnifying Party 13.3
Indirect Tax 8.4
Information Request Notice 4.7(b)
Infringement Action 9.3(c)(i)
IRB/EC 4.3
JMC 3.2
JSC 3.1(a)
License 2.1
Losses 13.1
MAA 1.66
Manufacturing Technology Transfer 4.3(b)
Manufacturing Technology Transfer Plan 4.3(b)
NDA 1.66
Party/Parties Preamble
Patent Certification 9.3(a)

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[***] 1.69
Pricing and Reimbursement Approvals 1.23
Product Infringement 9.3(a)
Protocol 14.3(d)
PHSA 9.3(a)
Receiving Party 10.1
Regulatory Audit 4.5(f)(ii)
Regulatory Milestone Event 7.4
Regulatory Milestone Payment 7.4
Remainder 9.3(g)
Representatives 10.1
Royalty Term 7.7
Sales Milestone Event 7.5
Sales Milestone Payment 7.5
SEC 10.5(a)
Securities Purchase Agreement 1.58
Selling Entity 1.69
Senior Executive 3.1(f)
Term 12.1
Third Party Competitive Product 9.3(a)
Transferred IND 5.4(b)(ii)
Upfront Payment 7.1
Vaxart Preamble
Vaxart Indemnitee 13.1
Vaxart Manufacturing Personnel 4.3(b)(iv)
Vaxart Platform Recitals

2.         License Grants

2.1         License Grant to Dynavax. Subject to the terms and conditions of this Agreement, Vaxart hereby grants to Dynavax an exclusive (even as to Vaxart), worldwide, royalty-bearing license, including the right to sublicense through multiple tiers in accordance with Section 2.2, under the Vaxart Technology and Vaxart’s interest in Joint Technology, solely to Develop, Manufacture, have Manufactured, use, sell, have sold, offer for sale, import, and otherwise Commercialize Compounds (including the Vaccine Candidate) and Products in the Field in the Territory (the “License”).

2.2         Sublicenses. The License shall include the right to grant Sublicenses through multiple tiers of Sublicense; provided that (a) each such Sublicense shall be in writing and shall be subject to, and consistent with, the terms and conditions of this Agreement, and (b) Dynavax shall be fully responsible for the compliance of its Sublicensees with the terms and conditions of this Agreement and for the performance of Dynavax’s obligations hereunder. Dynavax shall promptly notify Vaxart in writing of the execution of any Sublicense agreement with a Sublicensee; except that Dynavax may freely sublicense its rights under the License to Affiliates, distributors or Third Parties working under Dynavax’s direction or control without notifying Vaxart of any such Sublicense.

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2.3         License Grants to Vaxart; Retained Rights.

(a)         Subject to the terms and conditions of this Agreement, Dynavax hereby grants to Vaxart a non-exclusive, royalty-free, fully-paid license, without the right to grant sublicenses (but with the right to delegate or subcontract to Vaxart’s Affiliates or Third Party contractors, subject to Section 2.4), under the Vaxart Technology and Joint Technology, solely to the extent necessary:

(i)         to conduct and complete the Phase 2b Trial and such other Development activities with respect to the Vaccine Candidate as are necessary or advisable to prepare for and conduct an end-of-Phase 2 meeting with the FDA regarding the Vaccine Candidate (the “EOP2 Meeting”) and otherwise to perform Vaxart’s obligations with respect to the Vaccine Candidate under the Development Plan, in each case, during the Development Program Term;

(ii)         to perform Vaxart’s obligations under its ATI‑RRPV Base Agreement and Project Award Agreement for the Vaccine Candidate, each as modified to date, during the term of such agreements;

(iii)       **** [***] to make and have made the Vaccine Candidate and Product comprising or containing the Vaccine Candidate for use in the conduct of the activities described in Sections 2.3(a)(i) and 2.3(a)(ii); and

(iv)       **** [***] to develop, make, have made, and use the Vaccine Candidate and Product comprising or containing the Vaccine Candidate as necessary to perform its technology transfer and transition obligations to Dynavax under Section 4.3.

(b)         For clarity, and notwithstanding anything contained herein to the contrary, Vaxart retains all rights to practice, and to grant licenses under, the Vaxart Technology for any and all purposes outside of the Field.

2.4         Use of Affiliates, Contractors and Sublicensees. Each Party may perform any or all of its obligations or exercise any or all of its rights under this Agreement, through one or more of its Affiliates or Third Party contractors, or, in the case of Dynavax and subject to Section 2.2, Sublicensees; provided, in each case, that: (a) none of the other Party’s rights hereunder are diminished or otherwise adversely affected as a result of such delegation or contracting; (b) each such Affiliate, Third Party contractor, and, in the case of Dynavax, Sublicensee, undertakes in writing obligations of confidentiality and non-use regarding Confidential Information of the other Party which are at least as stringent as those undertaken by such Party pursuant to Article 10; and (c) each such Affiliate and Third Party contractor of a Party makes a written present assignment, and agrees in writing to assign, to such Party any and all Inventions generated or made by such Affiliate or contractor in the course of performing the delegated or contracted activities, as necessary for such Party to comply with its obligations under Section 9.2(c); provided, further, that such Party shall at all times be fully responsible for the performance of such Affiliate, Third Party contractor or Sublicensee and the compliance of such Affiliate, Third Party contractor or Sublicensee with this Agreement; and provided, further, that Vaxart will obtain Dynavax’s prior written consent (not to be unreasonably withheld, conditioned or delayed) before performing any Development Program Activity through a CMO or CRO other than a CMO or CRO listed on Exhibit E.

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2.5         No Implied Licenses. No right or license under any Patent Rights, Know-How or other intellectual property rights or information is granted or shall be granted by implication. All such rights or licenses are or shall be granted only as expressly provided in this Agreement.

3.         Governance

3.1         Joint Steering Committee.

(a)        Establishment and Composition.  Within [***] after the Effective Date, the Parties shall establish a joint steering committee (the “JSC”) composed of an equal number of (but in no event less than [***]) representatives of each of Vaxart and Dynavax, and each Party shall designate its initial JSC representatives by written notice to the other Party.  Each Party shall be free to change its JSC representatives on written notice to the other Party, provided that each Party shall ensure that, at all times during the existence of the JSC, its representatives on the JSC have appropriate expertise for the then-current stage of Development of Compounds and Products and appropriate seniority (including at least one member of senior management) and have the authority to bind such Party with respect to matters requiring approval of the JSC.

(b)         Responsibilities and Authority. The JSC’s overall responsibility shall be to encourage and facilitate collaboration and communication between the Parties regarding the Development Program and the Manufacturing Technology Transfer, to oversee the Manufacturing Technology Transfer, and to consider and address issues that may arise in the Development Program or the Manufacturing Technology Transfer, as more fully described in this Article 3. The specific responsibilities of the JSC shall be:

(i)         **** to periodically ([***]) review the Development Plan and, subject to Sections 3.1(e) and 3.1(f), approve updates or amendments thereto from time to time;

(ii)         to provide a forum for review and discussion of the progress and results of Development Program Activities, including Data generated in such activities;

(iii)       **** to review on a [***] basis the expenditure to date on Development Program Activities, including against Vaxart’s cost estimates as of the Effective Date;

(iv)         to encourage and facilitate ongoing cooperation and communication between the Parties with respect to the Development Program and in planning, and, following Dynavax’s payment to Vaxart of the Dynavax Election Payment, executing the transfer of responsibility for further Development of Compounds and Products to Dynavax upon completion of the Development Program;

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(v)         to serve as the principal means (in addition to the reports each Party is obligated to deliver to the other Party pursuant to Section 4.6) by which (A) Vaxart keeps Dynavax reasonably informed regarding the progress and results of Development Program Activities, and (B) the Parties discuss technical or other issues arising in the course of the foregoing activities;

(vi)         to facilitate the Manufacturing Technology Transfer;

(vii)         to establish Subcommittees (in addition to the JMC) as it deems necessary or advisable to further the purposes of the Development Program; and, in each case, to delegate to such Subcommittees such of the JSC’s responsibilities as the JSC deems appropriate, subject to Sections 3.1(f) and 3.3;

(viii)         to resolve disputes referred to it by Subcommittees; and

(ix)         to carry out such other obligations as are expressly delegated to it under this Agreement.

Each Party shall be responsible for ensuring that, at all times, its representatives attending any meeting of the JSC (and any Subcommittee thereof) act reasonably and in good faith in carrying out their respective responsibilities hereunder or, as applicable, in conducting themselves at such meeting.

c)         Meetings.  The JSC shall meet on at least a [***] basis or at such greater frequency as mutually agreed by the Parties during the Development Program Term and for [***] thereafter.  JSC meetings may be conducted in person at times and places to be determined by the JSC members.  Alternatively, the JSC may meet by means of teleconference, videoconference or other similar communications equipment.  A reasonable number of additional representatives of a Party may attend meetings of the JSC in a non‑voting capacity.  Each Party shall bear its own expenses of participating in meetings of the JSC.  [***] shall be responsible for chairing JSC meetings.  The chair for a JSC meeting shall set and circulate an agenda for such JSC meeting reasonably in advance thereof, provided that the agenda shall include any matter requested by either Party.  The chair for any JSC meeting shall not have any greater authority than any other representative of either Party on the JSC.

(d)       Minutes.  The JSC chair for a meeting shall be responsible for preparing minutes of such meeting and shall circulate a draft of the minutes of such meeting to all members of the JSC for comments within [***] Business Days after such meeting.  Such minutes shall provide a description, in reasonable detail, of the discussions at the meeting and shall document all actions and determinations approved by the JSC at such meeting.  In addition, in the event of discussion at any JSC meeting of any amendment or update to the Development Plan, the applicable document shall be attached to the minutes as an exhibit.  The Parties shall promptly discuss any comments on such minutes and finalize the minutes no later than the date of the next JSC meeting or within [***] of the first circulation of the draft minutes, whichever is earlier.

(e)        Decision-Making.  Decisions within the scope of the JSC’s authority shall be made by [***] vote.  The presence of at least one of each Party’s JSC representatives constitutes a quorum for the conduct of business at any JSC meeting, and no vote of the JSC may be taken without a quorum present.  If the JSC is unable to decide or resolve unanimously any matter within the scope of its authority and responsibilities, then such matter shall be resolved in accordance with Section 3.1(f).

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(f)        Dispute Resolution.  If the JSC is unable to decide or resolve unanimously any matter properly presented to it for action, then, at the written request of either Party, the issue shall be referred to the Chief Executive Officer of Vaxart and the Chief Executive Officer of Dynavax, or their respective designees with decision-making authority (in each case, such Party’s “Senior Executive”), who shall promptly meet and attempt in good faith to resolve such issue within [***] after such referral.  If the Senior Executives cannot resolve such matter within [***] after the date such matter is first referred to them, then, subject to the remainder of this Section 3.1(f) and to Section 3.3:

(i)         **** [***] shall have final decision-making authority with respect to any matter relating to [***]; provided, however, that unanimous approval of both Parties’ JSC representatives (without resort to [***]’s final decision-making authority) shall be required:

(1)        **** [***]; or

(2)        **** [***];

(ii)        **** [***] shall have final decision-making authority with respect to [***]; provided, however, that unanimous approval of both Parties’ JSC representatives (without resort to [***]’s final decision-making authority) shall be required to [***]; and

(iii)       **** in the case of any matter relating to the [***], [***] shall have final decision-making authority on the matter;

in each case, provided, however, that a Party having any final decision-making authority as expressly set forth above in Section 3.1(f)(i), Section 3.1(f)(ii), or Section 3.1(f)(iii) shall give good faith consideration to the other Party’s position and make reasonable efforts to take the other Party’s position into account in making its decision.

(g)         No Arbitration. The Parties intend that all matters within the scope of the JSC’s decision-making authority shall be resolved by the Parties in accordance with Sections 3.1(e) and 3.1(f), and no matter within the scope of the JSC’s authority shall be subject to the dispute resolution mechanisms set forth in Article 14.

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3.2       Subcommittees.  Within [***] after the Effective Date, the Parties shall establish a joint manufacturing committee (the “JMC”) (a) to monitor Vaxart’s performance of CMC Development activities with respect to the Vaccine Candidate and related Product during the Development Program Term, (b) to oversee and facilitate Vaxart’s performance of its Manufacturing Technology Transfer support and technical assistance obligations under Section 4.3(b), subject to Sections 3.1(f)(iii) and 3.3, and (c) to share and discuss information related to or resulting from the foregoing activities.  In addition, from time to time, the JSC may establish additional subcommittees to oversee particular projects or activities within the scope of authority of the JSC, as it deems necessary or advisable.  Each Subcommittee shall be composed of an equal number of representatives of each Party as the JSC determines is appropriate from time to time and shall meet with such frequency as the JSC shall determine.  Matters relating to the composition (other than the number of representatives), meetings, minutes, and decision-making and dispute resolution authority of each Subcommittee shall be as set forth in Sections 3.1(a), 3.1(c), 3.1(d) and 3.1(e), respectively, mutatis mutandis.  If, with respect to a matter that is subject to a Subcommittee’s decision-making authority, the Subcommittee cannot reach unanimity, the matter shall be referred to the JSC for resolution.

3.3       Scope of Authority; Exclusions.  Notwithstanding the establishment and existence of the JSC or any Subcommittee, each Party shall retain the rights, powers and discretion granted to it hereunder, and neither the JSC nor any Subcommittee shall be delegated or vested with rights, powers or discretion unless such delegation or vesting is expressly provided herein.  In addition to any other exclusions from or limitations on its authority set forth in this Article 3 or elsewhere in this Agreement, neither the JSC (including [***] in the exercise of its final decision-making authority under Section 3.1(f)) nor any Subcommittee shall have any right or authority:

(a)         to interpret, modify, amend, or waive compliance with any provision of, or any right or remedy under, this Agreement;

(b)         to determine whether or not a Party has complied with any of its obligations under this Agreement;

(c)         to determine any issue in a manner that would conflict with the express terms of this Agreement; or

(d)         to make any decision or approve any matter that is expressly stated to require the mutual written agreement of the Parties or the written consent of one or both Parties.

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3.4       Discontinuation of JSC.  The activities to be performed by the JSC shall solely relate to governance and information-sharing under this Agreement, and are not intended to constitute, or involve the delivery of, services.  The JSC shall continue to exist until the first to occur of: (a) the Parties mutually agreeing in writing to disband the JSC; (b) acceptance for filing by the FDA of a U.S. BLA for the Vaccine Candidate filed by Dynavax; or (c) Dynavax’s delivery to Vaxart, at any time after completion of the Manufacturing Technology Transfer to Dynavax’s reasonable satisfaction, of notice that Dynavax elects to disband the JSC.  Upon the occurrence of the first to occur of the foregoing (clause (a), clause (b), or clause (c)), the JSC shall have no further authority or duties under this Agreement; provided, however, that, notwithstanding the foregoing, the JMC shall continue in existence, and continue to perform its responsibilities and functions described in Section 3.2, thereafter until [***].  After the JSC ceases to exist, (i) each Party shall designate a contact person for the exchange of information previously exchanged through the JSC (and, after the JMC ceases to exist, information previously exchanged through the JMC), and (ii) any decisions that are designated under this Agreement as being subject to the review or approval of the JSC shall be made by mutual written agreement of the Parties directly (other than any matter that was subject to the final decision-making authority of [***] under Section 3.1(f) of this Agreement, which shall be decided directly by [***]), subject to the other terms and conditions of this Agreement.

3.5       Alliance Managers.  Within [***] after the Effective Date, each Party shall appoint (and notify the other Party of the identity of) a representative of such Party to act as the primary point of contact for the Parties with responsibility for the smooth functioning of the alliance by creating and maintaining collaborative, efficient, and responsive communications within and between Vaxart and Dynavax (each, an “Alliance Manager”).  A Party may replace its Alliance Manager on written notice to the other Party and may designate a substitute to temporarily perform the functions of that Alliance Manager by written notice to the other Party.  The Alliance Managers shall support alliance governance activities and shall attend all JSC meetings (except as otherwise determined by the JSC) and support their chairperson of the JSC in the discharge of their responsibilities but shall be non-voting participants in such JSC meetings.

3.6       [***].  For purposes of this Section 3.6, [***].

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4.         Development Program and Dynavax Election

4.1       Overview.  During the Development Program Term, under the oversight of the JSC and subject to the terms and conditions of this Agreement, Vaxart shall retain sole control of, and have sole responsibility for, (a) the Development of the Vaccine Candidate through the completion of the Phase 2b Trial and the EOP2 Meeting, including the performance of Vaxart’s BARDA Obligations, and (b) the Vaccine Candidate and related Product Manufactured by Vaxart for the Phase 2b Trial (collectively, the “Development Program”).  Notwithstanding the foregoing, during the Development Program Term: (i) Dynavax, in consultation with Vaxart, shall have the right, at Dynavax’s sole expense, to conduct, or have conducted by Third Parties on Dynavax’s behalf, CMC Development and Manufacturing activities with respect to the Vaccine Candidate and related Product (including the right to Manufacture, or have Manufactured, the Vaccine Candidate and related Product) in preparation for future Clinical Trials thereof and for the purpose of generating Data in support of Marketing Approval Applications for the Vaccine Candidate and related Product; and (ii) [***], (2) neither any of the BARDA Obligations nor any other activities for which Vaxart is responsible under the ATI-RRPV Base Agreement and Project Award Agreement shall be subcontracted or delegated to, or performed by, Dynavax, and (3) none of the funding provided to Vaxart pursuant to its Project NextGen/BARDA award, the ATI-RRPV Base Agreement, or the Project Award Agreement will be provided or made available by Vaxart to Dynavax.

4.2         Development Plan.

(a)         The activities to be undertaken by Vaxart as part of the Development Program shall be set forth in a written development plan (the “Development Plan”), which shall describe in reasonable detail the Development Program Activities and shall include a non‑binding estimate of the timeline for conducting the Development Program Activities and a reasonably detailed non-binding budget for the conduct of Development Program Activities over the Development Plan Term, including Vaxart’s good faith estimate of the costs and expenses to be incurred in conducting Development Program Activities and the anticipated timing thereof, broken out by calendar month (the “Development Program Budget”). The initial Development Plan agreed to by the Parties as of the Effective Date is attached hereto as Exhibit C.

(b)         The Development Plan shall be subject to amendment and update from time to time in accordance with Article 3, including amendments and updates to take into account completion, commencement, or cessation of Development Program Activities.

(c)        **** Vaxart shall use [***] to complete all Development Program Activities in accordance with the timeline set forth in the Development Plan and shall perform all BARDA Obligations in accordance with the terms and conditions of Vaxart’s Project NextGen/BARDA award and related ATI-RRPV Base Agreement and Project Award Agreement related to the Vaccine Candidate.

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4.3         Technology Transfer.

(a)        Vaxart Know-How.  As soon as practicable, and in any event within [***] after the Effective Date, and without limiting Vaxart’s obligation to perform the Manufacturing Technology Transfer contemplated by Section 4.3(b), Vaxart shall, at no additional charge to Dynavax, disclose and transfer to Dynavax or its designated Affiliate such existing and available (in recorded form) Vaxart Know-How in the possession or control of Vaxart or any Affiliate of Vaxart as of the Effective Date as may be necessary or useful for Dynavax (i) to exercise the License in accordance with this Agreement, including, without limitation, to Develop and Manufacture, or have Manufactured, the Vaccine Candidate and Products containing or comprising the Vaccine Candidate, including the Vaxart Platform components thereof; (ii) to use and incorporate the Vaxart Platform in Compounds; (iii) to prepare and file INDs and Marketing Approval Applications for Compounds and Product, and to obtain and maintain Commercialization Approvals for Products, in each case, in the Field; and (iv) otherwise exercise Dynavax’s rights and perform Dynavax’s obligations under this Agreement.  On a prompt and regular basis from time to time after such initial delivery of Vaxart Know-How to Dynavax or its designated Affiliate, Vaxart shall disclose and transfer to Dynavax from such additional Vaxart Know-How arising during the Development Program Term as is necessary or useful for the conduct of the activities described in the preceding sentence; provided that Vaxart shall disclose and transfer Vaxart Know-How arising after the Effective Date to Dynavax (A) no later than [***] after the generation or acquisition of such Vaxart Know-How or (B) promptly, and no later than [***], after any reasonable request by Dynavax.  Without limiting the generality of the foregoing, Vaxart shall provide to Dynavax true and complete copies of (1) all written, graphic, or electronic embodiments of Data generated by or on behalf of Vaxart with respect to Compounds and Products promptly (and in any event within [***]) following the first availability thereof, (2) draft and final protocols of each preclinical study and Clinical Trial of any Compound or Product conducted by or on behalf of Vaxart or any of its Affiliates before or after the Effective Date, including any amendment thereto, in each case, promptly (and in any event within [***]) following the first availability thereof, and (3) draft and final reports of all research, preclinical and non-clinical studies, including in vitro, in vivo, and ex vivo studies, Clinical Trials, and other testing (including CMC testing) of any Compound or Product conducted by or on behalf of Vaxart or any of its Affiliates before or after the Effective Date promptly (and in any event within [***]) following the first availability thereof.  In addition to disclosing and transferring Vaxart Know-How to Dynavax in accordance with this Section 4.3(a), Vaxart and its personnel will provide Dynavax with reasonable technical assistance with respect to such Vaxart Know-How, at Dynavax’s reasonable request and at no additional charge to Dynavax, during the Development Program Term and for [***] thereafter.

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(b)       Manufacturing Technology Transfer.  Vaxart [***] of Vaxart Technology used by or on behalf of Vaxart in the Manufacture of the Vaccine Candidate and related Product, including transfer of the Manufacturing process for each of the Vaccine Candidate (including the Vaxart Platform components thereof) and related Product (the “Manufacturing Technology Transfer”), and Vaxart shall [***] (as may be updated from time to time by the Parties, the “Manufacturing Technology Transfer Plan”) at [***].  The Manufacturing Technology Transfer Plan:

(i)         shall include, and shall be performed in accordance with, a timeline that Dynavax in good faith determines is necessary for initiation of Manufacture of Phase 3 Trial clinical material of the Vaccine Candidate and related Product;

(ii)        **** shall include [***] (“Phase 2b Material”), the master batch record for Manufacture of the Phase 2b Material, documentation of all analytical methods used to test the Phase 2b Material for conformity to the applicable specifications, and all Regulatory Documentation submitted or received by Vaxart regarding the Manufacture of the Vaccine Candidate and related Product;

(iii)       **** shall provide for Vaxart to provide [***]; and

(iv)       **** shall identify by name in writing those personnel of Vaxart possessing expertise in the Manufacture of the Vaccine Candidate and related Product who will support the Manufacturing Technology Transfer (the “Vaxart Manufacturing Personnel”).  [***]

Notwithstanding any of the foregoing provisions of this Section 4.3(b) to the contrary, [***] after the Effective Date (whether or not the Manufacturing Technology Transfer Plan has yet been prepared or approved), Dynavax may, by written notice to Vaxart, require Vaxart to disclose and transfer to Dynavax or the Dynavax CMO(s) true and complete copies of any or all existing written and electronic documentation in the possession or control of Vaxart or any of its Affiliates relating to the Manufacture of the Vaccine Candidate or related Product, including any or all of the items listed in clause (ii) above in this Section 4.3(b), in which event Vaxart shall disclose and transfer the requested documentation within [***] after Dynavax’s written request therefor.  For clarity, Dynavax shall be responsible for conducting or having conducted all CMC Development for the Vaccine Candidate and related Product after the Effective Date, at Dynavax’s sole cost and expense, but excluding CMC Development of the Vaxart Platform generally or the Vaxart Platform for use or incorporation in compounds that are not Compounds or products that are not Products, for which Vaxart shall be solely responsible at Vaxart’s sole cost and expense.

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4.4       Regulatory Matters.  Vaxart shall maintain the open/active status of the Vaccine Candidate IND at all times during the conduct of the Development Program.  Vaxart shall be responsible for all regulatory responsibilities relating to the Vaccine Candidate and Product containing the Vaccine Candidate during the conduct of the Development Program as required by Applicable Law, including safety reporting obligations to Regulatory Authorities, institutional review boards or ethics committees (each, an “IRB/EC”) and investigators, and submission of all other reporting and publication requirements under Applicable Law.  Subject to the terms of this Section 4.3, Vaxart shall have the sole responsibility for, and sole authority with respect to, communications with Regulatory Authorities regarding the Vaccine Candidate and Product containing the Vaccine Candidate during the conduct of the Development Program, provided that Dynavax shall have the right to attend all scheduled meetings between Vaxart and Regulatory Authorities pertaining to the Vaccine Candidate and Product containing the Vaccine Candidate, including the EOP2 Meeting, unless the Parties have agreed otherwise in writing in advance of such meeting.  Vaxart shall provide Dynavax with reasonable advance notice of all scheduled meetings with Regulatory Authorities regarding the Vaccine Candidate or Product containing the Vaccine Candidate and, as available, advance copies of documents relating to such meetings.  In addition, in the event that Vaxart is notified of any material inquiries from Regulatory Authorities that relate to the Vaccine Candidate and Product containing the Vaccine Candidate during the conduct of the Development Program, Vaxart shall promptly (but in no event later than [***] after Vaxart’s receipt of such inquiries) notify Dynavax of such inquiries.  Vaxart will (i) provide Dynavax for review and comment at least [***] in advance of any deadline for comments (or if any Regulatory Authority deadline is sooner, as reasonably in advance as possible), copies of all Regulatory Documentation with respect to the Vaccine Candidate or Product containing the Vaccine Candidate to be submitted by or on behalf of Vaxart prior to the relevant submission during the Development Program Term; (ii) incorporate reasonable comments thereto provided by Dynavax; and (iii) promptly notify and provide Dynavax any Regulatory Documentation received from any Regulatory Authority with respect to the Vaccine Candidate or Product containing the Vaccine Candidate.

4.5         Performance Standards; Compliance. Vaxart shall perform the Development Program Activities in accordance with the terms and conditions of this Agreement, in good scientific manner and in compliance with Applicable Law, including, as applicable, those relating to GLP, GCP, GMP, pharmacovigilance and safety reporting, and requirements for the protection of human subjects. Without limiting the generality of the foregoing:

(a)         Notifications. Vaxart shall notify Dynavax immediately in the event that it becomes aware of any of the following with respect to the Phase 2b Trial or any other Clinical Trial of the Vaccine Candidate: (i) changes that may be required by any Regulatory Authority; (ii) any safety or technical issue; (iii) an expected or actual delay, or any issue that may reasonably be expected to give rise to a delay; (iv) any stop work order issued by any Governmental Authority with respect to the Phase 2b Trial or any termination, reduction, or other change in status of the funding of the Phase 2b Trial by the U.S. Biomedical Advanced Research and Development Authority, pursuant to the ATI-RRPV Base Agreement and Project Award Agreement; or (v) any other substantive issue. Following receipt of notice of any such event, the Parties shall promptly meet to discuss the circumstance and Vaxart shall inform the Dynavax of its intended action plan to remedy (where possible) the issue or mitigate the delay risk to the Development Program. In determining an action plan, each Party shall take the other Party’s comments into consideration in good faith.

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(b)       Clinical Data.  Vaxart shall disclose to Dynavax in writing all Data generated in the Phase 2b Trial or any other Clinical Trial of the Vaccine Candidate, including safety data, data related to the sentinel cohort, topline data, and final data, in each case, promptly (and in any event within [***]) following the first availability thereof.

(c)         Informed Consent and Patient Authorization. In connection with the Phase 2b Trial and any other Clinical Trial of the Vaccine Candidate, Vaxart shall be responsible for obtaining all (i) informed consent documents, which shall have been approved by the IRB/EC, signed by or on behalf of each human study subject prior to the subject’s participation in the Phase 2b Trial; and (ii) HIPAA patient authorizations signed by or on behalf of each human study subject, as described in 45 C.F.R. Part 164 (or for sites outside of the U.S., the foreign equivalent), which authorizations shall contain such provisions as are necessary for Dynavax to have access to patient data to the extent reasonably necessary to exercise its rights and fulfill its obligations hereunder and as allowed under Applicable Law.

(d)         Clinical Study Registration and Results Reporting. Vaxart shall be responsible for registering the Phase 2b Trial and each other Clinical Trial of the Vaccine Candidate contemplated by the Development Plan and conducted by or on behalf of Vaxart during the Development Program Term in the appropriate clinical study registry and reporting the results thereof as may be required under Applicable Law.

(e)         Samples. Vaxart shall accept, to the extent permitted by Applicable Law, responsibility for the retention of documentation and storage of samples of Vaccine Candidate and Product used in the Phase 2b Trial and each other Clinical Trial of the Vaccine Candidate contemplated by the Development Plan and conducted by or on behalf of Vaxart during the Development Program Term according to Applicable Law.

(f)         Audits.

(i)         Co-Audits.  Any facility or site at which Vaxart conducts, or has conducted by a Third Party, any Development Program Activity shall be referred to herein as an “Audited Site”.  Vaxart shall permit Dynavax, at Dynavax’s own expense, upon reasonable (but in no event less than [***]’) written notice to Vaxart, and during normal business hours, to accompany Vaxart to inspect the Audited Site and any records relating to Development Program Activity conducted by the Audited Site to verify Vaxart’s compliance with Applicable Law in carrying out its obligations under this Agreement (each, an “Audit”).  Each Audit of an Audited Site may be conducted no more frequently than once every year without cause, and more frequently in the event of a “for cause” Audit.  Dynavax shall execute any such confidentiality or other agreements as may be reasonably required by each Audited Site as a condition precedent to the Parties’ conduct of the Audit.

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(ii)        Audits by Regulatory Authorities.  Vaxart shall inform Dynavax within [***] following its receipt of notice of an inspection of an Audited Site of Vaxart (including Vaxart itself) by a Regulatory Authority that relates to any Development Program Activity conducted at such Audited Site (“Regulatory Audit”).  Each Party shall cooperate in good faith with the Regulatory Authority during a Regulatory Audit of Vaxart.  Vaxart shall provide [***] updates to Dynavax regarding its knowledge of the status of a Regulatory Audit and, to the extent not prohibited by Applicable Law, provide to Dynavax any materials received by Vaxart from the Regulatory Authority or an Audited Site in relation thereto.

(iii)         Audit Observations. Vaxart shall provide Dynavax with written information received by Vaxart regarding results of an Audit or Regulatory Audit that relate to or impact any Development Program Activity conducted by such Audited Site (each, an “Audit Observation”). Vaxart shall provide the other Party an opportunity to review and comment on proposed corrective and preventative actions (“CAPA”) for Audit Observations of Vaxart (as the Audited Site), which Vaxart shall consider in good faith. Vaxart shall also provide the other Party with a copy of any proposed CAPA for Audit Observations received by Vaxart from an Audited Site, and allow the other Party to review and comment on such CAPA to the same extent as Vaxart. Vaxart shall use Commercially Reasonable Efforts to implement any such CAPAs pertaining to Vaxart (as the Audited Site) and shall provide information received by such Party from an Audited Site regarding the status of such CAPAs at such Audited Site. Notwithstanding the foregoing, Vaxart’s obligations related to Regulatory Audits in this Section 4.5(f) shall be limited to the extent the performance of such obligations is prohibited by Applicable Law or to the extent necessary to allow Vaxart to timely comply with Applicable Law.

4.6         Reports. During the existence of the JSC, Vaxart shall provide updates on its progress with respect to the Development Program Activities and a summary of the Data and results from such activities at each meeting of the JSC. During the existence of the JMC, Vaxart shall provide updates on its progress with respect to Development Program Activities related to manufacturing and a summary of the Data and results from such activities at each meeting of the JMC.

4.7         Delivery and Evaluation of EOP2 Data Package.

(a)        Delivery of EOP2 Data Package.  Vaxart shall prepare and deliver to Dynavax: (i) as promptly as practicable following the Phase 2b Trial Completion Date, a complete data package for the Vaccine Candidate, including the Data from the Phase 2b Trial, all related correspondence with the FDA, and additional data and information as further described in Exhibit D; and (ii) within [***] after Vaxart’s receipt of the minutes from the EOP2 Meeting, a true and complete copy of such minutes (clauses (i) and (ii), collectively, the “EOP2 Data Package”). For clarity, delivery of the EOP2 Data Package to Dynavax shall not relieve Vaxart of its obligations with regard to Development Program Activities to be conducted or completed after the Phase 2b Trial Completion Date during the Development Program Term or its obligations under Section 4.3.

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(b)       Evaluation of Data Package; Decision to Proceed to Further Clinical Development.  Within [***] after Dynavax’s receipt of the EOP2 Data Package, the JSC (together with, if necessary, appropriate Vaxart representative(s) with relevant knowledge and information regarding the Development Program Activities and the Vaccine Candidate but who are not JSC members) shall meet to discuss the EOP2 Data Package, to determine whether any document or information described in Section 4.7(a) is missing from the EOP2 Data Package delivered to Dynavax (in which case, Vaxart shall promptly deliver the same to Dynavax), and to discuss the results from the Phase 2b Trial.  The Parties acknowledge that the decision for Dynavax to assume responsibility for continued clinical Development of the Vaccine Candidate shall be made solely by Dynavax in its absolute discretion; provided, however, that Dynavax shall communicate such decision to Vaxart in writing (the “Election to Proceed Notice”) no later than [***] after, as applicable, (i) [***] or (ii) [***] (such Business Day, in each case (clause (i) or clause (ii)), the “Election Period Commencement Date”, and the [***] period commencing on the Election Period Commencement Date, the “Election Period”); provided, however, that [***], and, for the avoidance of doubt, [***].  Without limiting the generality of the foregoing, at any time following Dynavax’s receipt of the EOP2 Data Package and the date which is [***] prior to the end of the Election Period, Dynavax may provide Vaxart with one or more written notices requesting information with respect to the Development Program and the Vaccine Candidate that is available as of the Phase 2b Trial Completion Date but has not previously been provided to Dynavax or the JSC or JMC, or requesting a discussion with Vaxart representative(s) who have the relevant knowledge and information regarding such Development Program and Vaccine Candidate (each, an “Information Request Notice”).  Vaxart will provide such information or hold such discussion as promptly as practicable, provided that Vaxart will provide any information reasonably accessible to or Controlled by Vaxart and hold any such discussion regarding such information no later than [***] following receipt of such Information Request Notice but in any event no later than [***] prior to expiration of the Election Period.  If the Election Period expires without Dynavax having delivered to Vaxart an Election to Proceed Notice, then, provided that Vaxart has timely responded to all Information Request Notices, upon the expiration of such Election Period (or upon such earlier date as Dynavax notifies Vaxart in writing that Dynavax does not intend to deliver an Election to Proceed Notice), (A) Vaxart shall have the right to terminate this Agreement immediately upon written notice to Dynavax, pursuant to Section 12.4 and (B) the License granted to Dynavax under this Agreement shall terminate.

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4.8         Records. Vaxart shall prepare and maintain, or cause to be prepared and maintained, complete and accurate records of all Development Program Activities, including all Data, results and information arising therefrom and any Invention made in whole or in part by or on behalf of Vaxart in connection therewith. All such records shall be prepared and maintained in conformity with standard pharmaceutical and biotechnology industry practices and in sufficient detail appropriate for patent and regulatory purposes. Upon reasonable prior written notice, Vaxart shall permit the Dynavax to review such records (including, to the extent permitted by Applicable Law related to data privacy, the clinical study reports and case report forms) to the extent reasonably required for the performance of Dynavax’s obligations or the exercise of the Dynavax’s rights under this Agreement. Dynavax shall maintain such records of Vaxart and the information contained therein in confidence in accordance with Article 10 hereof and shall not use such records or information except to the extent permitted by this Agreement.

4.9         Material Safety Issues. If, during the Development Program Term, either Party determines that there is a Material Safety Issue, such Party shall promptly notify the other Party, and the JSC shall promptly meet to discuss such Material Safety Issue. In the event of a Material Safety Issue that arises prior to Dynavax’s payment to Vaxart of the Dynavax Election Payment and the assignment by Vaxart to Dynavax of the Vaccine Candidate IND, Vaxart may suspend or delay any Development Program Activity to the extent such activity is affected by such Material Safety Issue, and shall, to the extent required, take all actions as may be required by Applicable Law (e.g., regulatory reporting) and such other actions as Vaxart determines are appropriate to address such Material Safety Issue. In the event of a Material Safety Issue that arises after Dynavax’s payment to Vaxart of the Dynavax Election Payment and the assignment by Vaxart to Dynavax of the Vaccine Candidate IND, Dynavax may require the suspension or delay of any Development Program Activity to the extent such activity is affected by such Material Safety Issue, and shall, to the extent required, take all actions as may be required by Applicable Law and such other actions as Dynavax determines are appropriate to address such Material Safety Issue.

5.         Development and Commercialization Following Election

5.1         Responsibility. From and after Dynavax’s payment to Vaxart of the Dynavax Election Payment, Dynavax shall be solely responsible for the Development, Manufacture and Commercialization of Compounds and Products in the Field in the Territory, all at Dynavax’s sole expense, provided that Vaxart shall perform: (a) its obligations under Sections 4.3(a), 4.4, 4.5, 4.6, 4.8, and 5.4 at no cost to Dynavax; and (b) its obligations under Section 4.3(b) at no cost to Dynavax, except as expressly set forth in the Manufacturing Technology Transfer Plan.

5.2       Diligence.  During the Term, after Dynavax’s payment to Vaxart of the Dynavax Election Payment, Dynavax (itself and through its Affiliates and Sublicensees) shall use Commercially Reasonable Efforts to [***].

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5.3         Compliance. Dynavax shall conduct, and require its Affiliates, Third Party contractors and Sublicensees to conduct, all activities contemplated by this Article 5 in compliance with all Applicable Law, including, as applicable, those relating to GLP, GCP, GMP, pharmacovigilance and safety reporting, and requirements for the protection of human subjects.

5.4         Regulatory.

(a)         Dynavax Responsibility. Without limiting the generality of Section 5.1, after Dynavax’s payment to Vaxart of the Dynavax Election Payment, Dynavax shall be solely responsible for preparing and submitting all INDs and Marketing Approval Applications, and obtaining and maintaining all Regulatory Approvals, for Compounds and Products in the Field in the Territory, at Dynavax’s sole expense. All of such submissions and Regulatory Approvals shall be in the name of, and owned by, Dynavax (or its Affiliate or Sublicensee, as applicable).

(b)         Rights of Reference; Transfer of Regulatory Documentation.

(i)         Drug Master Files.  In the event Vaxart or its Affiliate maintains a drug master file related to a Compound or Product, Vaxart hereby grants to Dynavax Rights of Reference thereto, and the right to access and copy all information and data included in such drug master file, to the extent necessary or reasonably useful for the purposes of (A) filing and maintaining INDs and other Regulatory Approvals for the conduct by or on behalf of Dynavax of Clinical Trials of such Compound or Product in the Field in the Territory, (B) filing MAAs and obtaining Marketing Approvals for Compounds and Products in the Field in the Territory, and (C) Developing, Manufacturing and Commercializing Compounds and Products in the Field in the Territory.  Vaxart shall, promptly upon (and in any event within [***] after) request of Dynavax, file with applicable Regulatory Authorities such letters of authorization, access or cross-reference as may be necessary to accomplish the intent of this Section 5.4(b)(i), provided that, except as contemplated by the Development Plan or mutually agreed by the Parties in writing, Dynavax shall not file any IND or MAA for a Compound or Product that references or relies upon any such drug master file or related letter of authorization, access or cross-reference prior to Dynavax’s payment to Vaxart of the Dynavax Election Payment.

(ii)         INDs, Marketing Approval Applications and Regulatory Approvals.

(1)         During the period prior to any assignment and transfer to Dynavax of any Vaxart IND and related Regulatory Documentation pursuant to Section 5.4(b)(ii)(2), Vaxart hereby grants to Dynavax Rights of Reference to such Vaxart IND and related Regulatory Documentation, solely to the extent necessary or reasonably useful for the purposes of, after Dynavax’s delivery to Vaxart of an Election to Proceed Notice in accordance with Section 4.7(b), filing and maintaining INDs and other Regulatory Approvals for the conduct by or on behalf of Dynavax of Clinical Trials of Compound or Product in the Field in the Territory.

(2)        **** Promptly (and in any event within [***]) following Dynavax’s payment to Vaxart of the Dynavax Election Payment: (A) Vaxart will assign and transfer to Dynavax each Vaxart IND (such transferred IND, the “Transferred IND”) and provide copies of all related Regulatory Documentation not previously provided to Dynavax.

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(3)        **** Vaxart shall, promptly upon (and in any event within [***] after) request of Dynavax, file with applicable Regulatory Authorities such letters of authorization, access or cross-reference as may be necessary to accomplish the intent of this Section 5.4(b)(ii).

(4)         For clarity, Vaxart shall have the right to retain a copy of any Transferred IND, provided that, upon assignment and transfer to Dynavax of a Transferred IND, such Transferred IND shall become the Confidential Information of Dynavax.

(c)         Global Safety Database. Vaxart shall retain global safety reporting obligations for the Vaccine Candidate or Product containing Vaccine Candidate as required by Applicable Law during the Development Program Term. After completion of the Development Program, Dynavax shall establish a global safety database for each Compound or Product, as applicable, and shall maintain such safety database in accordance with Applicable Law. In a timeframe to be agreed upon by the Parties, Vaxart shall disclose all safety information arising from the performance of the Phase 2b Trial to Dynavax for inclusion in the global safety database.

5.5         Records. Dynavax shall prepare and maintain, or cause to be prepared and maintained, complete and accurate records of all activities conducted by or on behalf of Dynavax pursuant to this Article 5, including all Data, results and information arising therefrom and any Invention made in whole or in part by or on behalf of Dynavax in connection therewith. All such records shall be prepared and maintained in conformity with Dynavax’s standard practices and in sufficient detail appropriate for patent and regulatory purposes.

5.6         Manufacturing. From and after payment of the Dynavax Election Payment, Dynavax shall have the sole right and authority, at its sole cost and expense, to Manufacture, or have Manufactured, clinical and commercial supplies of Compounds and Products for use in the Field.

6.         Exclusivity

6.1       Exclusivity Covenant.  Subject to Section 6.2. during the Term, Vaxart, on behalf of itself and its Affiliates, covenants that neither Vaxart nor any of Affiliates shall, directly or indirectly, independently, or for, with or through any Third Party, (a) conduct or participate in a Competing Program, (b) grant any right, including by assignment of or granting of a license or covenant not to sue under any intellectual property rights, that would have the effect of enabling a Third Party to [***] any Competing Product, or (c) otherwise enable any Third Party to conduct or participate in a Competing Program, in each case (clauses (a)-(c)), except in the performance of Vaxart’s obligations under, and in accordance with, this Agreement.

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6.2         Exceptions.

(a)         [***].

(b)         [***].  If, after the Effective Date and during the Term, [***], then [***]:

(i)         **** [***]; or

(ii)        **** [***].

In the event of [***], (1) [***], and (2) [***], (A) [***], and (B) [***].

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6.3         Enforceability. Vaxart acknowledges and agrees that (a) this Article 6 has been negotiated by the Parties, (b) the limitations on activities set forth in this Article 6 are reasonable, valid, and necessary in light of the Parties’ circumstances and necessary for the adequate protection of the business of the Compounds and Products and (c) Dynavax would not have entered into this Agreement without the protection afforded it by this Article 6. Dynavax and Vaxart believe that the restrictive covenants in this Article 6 are valid and enforceable and it is the desire and intent of the Parties that the restrictive covenants contained in this Article 6 be enforced to the fullest extent permissible under Applicable Law and public policies applied in each jurisdiction in which enforcement is sought. However, if any such restrictive covenant should for any reason become or be declared by a competent court or competition authority to be invalid or unenforceable in any jurisdiction, such restrictive covenant shall be deemed to have been amended to the extent necessary in order that such provision be valid and enforceable, and such amendment shall apply only with respect to the operation of such provision of this Article 6 in the particular jurisdiction in which such declaration is made. In furtherance of the foregoing, the court or competition authority is hereby requested and authorized by the Parties to revise this Article 6 to include the maximum restrictions allowable under Applicable Law in the applicable jurisdiction.

6.4         Other Activities. Except as expressly provided in this Article 6, Vaxart may engage in research, Development, Manufacturing, Commercialization or other exploitation activities that utilize technologies similar to or involve compounds, biologics or products similar to those contemplated by this Agreement. Except as expressly provided in this Agreement (including as provided in this Article 6), nothing in this Agreement, including any restriction on the use of Confidential Information, shall impose on Vaxart any obligation not to research, Develop, Manufacture, Commercialize or otherwise exploit any product.

7.         Financial Terms

7.1         Upfront Payment. Within [***] following the Effective Date, Dynavax shall pay to Vaxart a non-refundable, non-creditable upfront payment in the amount of $25,000,000 (the “Upfront Payment”).

7.2         Common Stock Purchase. On the Effective Date, the Parties would enter into the Investment Agreements, pursuant to which Vaxart will issue and sell to Dynavax, and Dynavax will purchase, $5,000,000 of Vaxart common stock, on the terms and subject to the conditions set forth in the Investment Agreements.

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7.3         [***] Dynavax Election Payment.

(a)         [***]:

(i)         [***].

(ii)        [***].

In the event that Dynavax delivers an Election to Proceed Notice to Vaxart, [***]. In the event that Dynavax does not [***].

(b)         Dynavax Election Payment. If Dynavax delivers to Vaxart an Election to Proceed Notice prior to the expiration of the Election Period, then Dynavax shall pay to Vaxart a non-refundable, non-creditable payment of $50,000,000, [***] (the “Dynavax Election Payment”), within [***] after such delivery; provided, however, that [***].

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7.4         Regulatory Milestone Payments. Within [***] following the first achievement (whether by Dynavax, its Affiliate or a Sublicensee) of each of the milestone events set forth in the table below (each, a “Regulatory Milestone Event”), Dynavax shall provide Vaxart with written notice of such achievement and shall pay to Vaxart the corresponding one-time, non‑refundable, non‑creditable milestone payment set forth in such table (each, a “Regulatory Milestone Payment”) within [***].

No. Milestone Event Milestone Payment
1 [***] US$[***]
2 [***] US$[***]
3 [***] US$[***]
4 [***] US$[***]
5 [***] US$[***]

Each Regulatory Milestone Payment shall be payable only one time, for the first achievement of the applicable Regulatory Milestone Event, regardless of the number of Products that may achieve such Regulatory Milestone Event. Accordingly, the maximum amount payable pursuant to this Section 7.4 shall be $195,000,000. For avoidance of doubt, [***].

7.5         Sales Milestone Payments. The first time that aggregate Net Sales of all Products in a single Calendar Year by Dynavax, its Affiliates and Sublicensees in the Territory equal or exceed the amounts set forth in the following table (each, a “Sales Milestone Event”), Dynavax shall pay to Vaxart the corresponding one-time, non‑refundable, non‑creditable milestone payment set forth in the table below (each, a “Sales Milestone Payment”) within [***] after the end of the Calendar Quarter in such Calendar Year in which such Sales Milestone Event is achieved in accordance with Section 8.1.

Milestone Event Milestone Payment
First Calendar Year in which aggregate annual Net Sales of all Products in the Territory equal or exceed US$[***] in such Calendar Year US$[***]
First Calendar Year in which aggregate annual Net Sales of all Products in the Territory equal or exceed US$[***] in such Calendar Year US$[***]
First Calendar Year in which aggregate annual Net Sales of all Products in the Territory equal or exceed US$[***] in such Calendar Year US$[***]
First Calendar Year in which aggregate annual Net Sales of all Products in the Territory equal or exceed US$[***] in such Calendar Year US$[***]
First Calendar Year in which aggregate annual Net Sales of all Products in the Territory equal or exceed US$[***] in such Calendar Year US$[***]
First Calendar Year in which aggregate annual Net Sales of all Products in the Territory equal or exceed US$[***] in such Calendar Year US$[***]

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Each Sales Milestone Payment shall be payable only one time, for the first Calendar Year in which aggregate Net Sales of all Products in the Territory for such Calendar Year exceed the specified amount. Accordingly, the maximum amount payable pursuant to this Section 7.5 shall be US$425,000,000. If multiple Sales Milestone Events are first achieved in a single Calendar Quarter during the same Calendar Year, the Sales Milestone Payments corresponding to all of such achieved Sales Milestone Events shall be payable within [***] after the end of such Calendar Quarter in accordance with Section 8.1.

7.6         Royalties. Subject to Sections 7.8, 7.9, 7.10 and 7.11 below, on a Product-by-Product and country-by-country basis, Dynavax shall pay to Vaxart tiered royalties on aggregate annual Net Sales of each Product by Dynavax, its Affiliates and Sublicensees in the Territory in each Calendar Year at the royalty rates set forth in the table below:

Aggregate Annual Net Sales of Each Product in the Territory Royalty Rate
On that portion of aggregate annual Net Sales of each Product by Dynavax, its Affiliates and Sublicensees in the Territory in a Calendar Year that is less than or equal to US$[***] [***]%
On that portion of aggregate annual Net Sales of such Product by Dynavax, its Affiliates and Sublicensees in the Territory in a Calendar Year that is greater than US$[***] and less than or equal to US$[***] [***]%
On that portion of aggregate annual Net Sales of such Product by Dynavax, its Affiliates and Sublicensees in the Territory in a Calendar Year that is greater than US$[***] [***]%

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7.7         Royalty Term. Royalties under Section 7.6 shall be payable, on a Product-by-Product basis, with respect to a Product in a country from the First Commercial Sale of such Product in such country until [***]: [***] (the “Royalty Term”). On a Product-by-Product and country-by-country basis, upon expiration of the Royalty Term for a Product in a country, the License with respect to such Product in such country shall become royalty-free, fully-paid, irrevocable and perpetual.

7.8         Reduction for No Valid Claim or Biosimilar Competition.

(a)         No Valid Claim. On a Product-by-Product and country-by-country basis, during any portion of the Royalty Term for a Product in a country when no Valid Claim of a Vaxart Patent or Joint Patent in such country Covers (i) the composition of matter of the Compound incorporated in such Product or (ii) any method of use of such Compound for an indication within the Field for which such Product has received Marketing Approval in such country, the royalties that would otherwise be payable to Vaxart under Section 7.6 with respect to Net Sales of such Product in such country shall be reduced by [***]%, subject to the application of the royalty floor under Section 7.11.

(b)         Biosimilar Competition. On a Product-by-Product and country-by-country basis, (i) upon the first sale in a country of the Territory of a Biosimilar Product with respect to a Product being sold by Vaxart or any other Selling Entity in such country during the Royalty Term for such Product in such country, the royalties due Vaxart under Section 7.6 with respect to Net Sales of such Product in such country shall immediately be reduced to [***]% of the amount otherwise payable; and (ii) if, after the Calendar Quarter during which the first sale of a Biosimilar Product for such Product in such country occurred, Net Sales of such Product in such country during the applicable Royalty Term [***] are less than [***]% of Net Sales of such Product in such country during the Calendar Quarter immediately preceding the Calendar Quarter during which the first sale of a Biosimilar Product for such Product in such country occurred, the royalties due Vaxart under Section 7.6 with respect to Net Sales of such Product in such country shall be reduced to [***]% of the amount otherwise payable; in each case of the foregoing clauses (i) and (ii), for such applicable Calendar Quarter and each subsequent Calendar Quarter during the Royalty Term.

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7.9         Third Party Payments. Subject to Section 7.11, in the event that Dynavax or its Affiliate or Sublicensee (as applicable) obtains one or more licenses under Patent Rights of Third Parties (excluding Sublicensees) that Cover, or are reasonably necessary or useful to make, use or sell, the Compound contained in a Product sold in a country (“Third Party Licenses”), then Dynavax may credit against the royalties payable by Dynavax to Vaxart with respect to Net Sales of such Product in such country for a Calendar Quarter [***]% of the royalties actually paid by Dynavax or such Affiliate or Sublicensee (as applicable) under such Third Party Licenses with respect to sales of such Product in such country for such Calendar Quarter; provided, however, that in no event will the royalties payable by Dynavax to Vaxart hereunder with respect to Net Sales of such Product in such country for such Calendar Quarter be reduced pursuant to this Section 7.9 by more than [***]% as a result of any and all such credits in the aggregate, [***]; and provided, further, that [***].

7.10         [***].

7.11         [***].

8.         Payment; Reports; Audits

8.1         Payment; Reports. Commencing with the First Commercial Sale of a Product by Dynavax or its Affiliates or Sublicensees, royalties shall be due and payable [***] after the end of each Calendar Quarter in which royalties are applicable. Each payment shall be accompanied with a report setting forth, on a Product-by-Product and country-by-country basis, the Net Sales of Products during such Calendar Quarter, the applicable royalty rate, the calculation and amount of the royalties due on such Net Sales (including the details of any Combination Product adjustment to such Net Sales and any reductions or offsets applied pursuant to Section 7.8 or Section 7.9) and the exchange rates used in calculating such royalties. All reports delivered by Dynavax under this Section 8.1 shall be Confidential Information of Dynavax.

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8.2         Exchange Rate. All invoice and payment amounts specified in this Agreement are expressed in U.S. Dollars, and all payments by Dynavax to Vaxart under this Agreement shall be paid in U.S. Dollars. When conversion of any amount invoiced, received, paid, incurred, or otherwise denominated in any foreign currency into U.S. Dollars is required for purposes of calculating amounts payable hereunder, such conversion shall be made at the rate of exchange for such currency used throughout Dynavax’s accounting system for financial reporting purposes for the Calendar Quarter for which payment is due.

8.3         Income Tax Withholding. The amounts payable by Dynavax to Vaxart to this Agreement will be paid free and clear of any and all taxes, except for any withholding taxes required by Applicable Law. Vaxart shall be solely responsible for paying any and all taxes (other than withholding taxes required by Applicable Law to be deducted from payments by Dynavax and remitted by Dynavax) levied on account of, or measured in whole or in part by reference to, any payments it receives from Dynavax. Dynavax shall deduct or withhold from such payments any taxes that it is required by Applicable Law to deduct or withhold. Notwithstanding anything to the contrary in the foregoing, if Vaxart is entitled under any applicable tax treaty to a reduction of rate of, or the elimination of, applicable withholding tax, then Vaxart may deliver to Dynavax or the appropriate Governmental Authority (with the assistance of Dynavax to the extent reasonably required and expressly requested by Vaxart in writing) the prescribed forms necessary to reduce the applicable rate of withholding or to relieve Dynavax of its obligation to withhold such tax and Dynavax shall apply the reduced rate of withholding or dispense with withholding as the case may be, provided that Dynavax has received evidence, in a form satisfactory to Dynavax, of Vaxart’s delivery of all applicable forms (and, if necessary, its receipt of appropriate governmental authorization) at least [***] prior to the time Payments are due. If, in accordance with the foregoing, Dynavax withholds any amounts of tax, then Dynavax shall pay to Vaxart the balance when due, make timely payment to the proper tax authority of the withheld amount and send to Vaxart proof of such payment within [***] following such payments.

8.4         Indirect Taxes. Amounts payable under this Agreement do not include any sales, use, excise, value added or other applicable taxes, tariffs or duties. If any taxing authority imposes a VAT, GST, sales, use, service, consumption, business or similar tax (any such tax, an “Indirect Tax”) with respect to the work undertaken under this Agreement, then Dynavax agrees to pay that amount if specified in a valid invoice or supply exemption documentation. For avoidance of doubt, Vaxart will not be entitled to pass on to Dynavax, and Dynavax will not be obligated to pay or bear, any tax that is based on Vaxart’s real, personal or intangible property (whether owned or leased), corporate structure, franchise, continuing business operations, income, gross receipts, capital stock, net worth or imposed with respect to Vaxart’s engagement of employees or independent contractors or that Vaxart incurs upon subcontracting any work hereunder, in whole or in part, to any Affiliate or Third Party. Vaxart is solely responsible, to the extent required by Applicable Law, for identifying, billing, and collecting any Indirect Tax payable by Dynavax with respect to payments under this Agreement in all relevant federal, state, county, municipal and other taxing jurisdictions and for filing all required tax returns in a timely manner. To the extent that Vaxart does not provide Dynavax a valid invoice (i.e., an invoice compliant with this Agreement and the rules and regulations of the jurisdictions of both Vaxart and Dynavax, including separate identification of the tax where legally required), Vaxart shall be responsible for any penalty resulting directly from such noncompliance. The Parties will cooperate in good faith to minimize taxes to the extent legally permissible.

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8.5         Records; Audits. Dynavax shall keep, and shall cause its Affiliates and Sublicensees to keep, complete and accurate records pertaining to the sale or other disposition of Products in sufficient detail to permit Vaxart to confirm the accuracy of all payments due hereunder, for at least three (3) full Calendar Years following the end of the Calendar Year to which they pertain. Vaxart shall have the right, once annually, to cause an independent, certified public accountant of international standing selected by Vaxart and reasonably acceptable to Dynavax to audit such records to confirm Net Sales, royalties, and the timing of achievement of Sales Milestone Events for a period covering not more than the preceding [***]. No Calendar Year shall be subject to audit under this section more than once. Such audits may be exercised during normal business hours upon no less than [***]’ prior written notice to Dynavax. The auditor will execute a reasonable written confidentiality agreement with Dynavax and will disclose to Vaxart only such information as is reasonably necessary to provide Vaxart with information regarding any discrepancies between amounts reported and actually paid and amounts payable under this Agreement. The auditor will send a copy of the report to Dynavax at the same time as it is sent to Vaxart. The report sent to both Parties will include the methodology and calculations used to determine the results. If such audit reveals that Dynavax has failed to accurately report information pursuant to Section 8.1 or to make any payment (or portion thereof) when due under this Agreement, then Dynavax, within [***] after receipt of the final audit report, shall pay to Vaxart any underpaid amounts due under this Agreement, together with interest on such underpaid or late amounts calculated in accordance with Section 8.6. Vaxart shall bear the full cost of such audit unless such audit discloses an underpayment by Dynavax of more than [***]% of the amount due for any Calendar Year under this Agreement, in which case Dynavax shall bear the full cost of such audit. If such audit discloses an overpayment by Dynavax, then Dynavax will deduct the amount of such overpayment from amounts otherwise owed to Vaxart under this Agreement.

8.6         Late Payments. In the event that any payment due under this Agreement (other than any portion thereof that is subject to a good faith dispute between the Parties during the pendency of dispute resolutions pursuant to Article 14) is not made when due, interest shall accrue on the late payment at a rate per month of [***]% or the maximum rate allowable by Applicable Law, whichever is lower, and shall be compounded monthly. The payment of such interest shall not limit a Party from exercising any other rights it may have as a consequence of the lateness of any payment.

9.         Intellectual Property

9.1         Ownership.

(a)         Inventorship. Inventorship of Inventions in the Territory shall be determined in accordance with U.S. patent laws; provided, however, that constructive reduction to practice through the mere filing or prosecution of a patent application shall not constitute inventorship or give rise to any ownership rights.

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(b)         Ownership of Inventions. Vaxart shall solely own all Vaxart Inventions. Dynavax shall solely own all Dynavax Inventions. The Parties shall jointly own all Joint Inventions. Except to the extent Vaxart has granted Dynavax the License under Vaxart’s joint ownership interest in Joint Technology, and subject to Dynavax’s payment, reporting and accounting obligations with respect to Products under this Agreement, each Party shall have the right to practice and use, and to grant licenses under, such Party’s own joint ownership interest in Joint Technology without the other Party’s consent, and shall have no duty to account to the other Party for such practice, use or license, and each Party hereby waives any right it may have under the laws of any country to require such consent or accounting.

9.2         Patent Prosecution and Maintenance. For purposes of this Section 9.2, the terms “prosecution” and “maintenance” (including variations such as “prosecute” and “maintain”) shall mean, with respect to a Patent Right, the preparation, filing, prosecution and maintenance (including payment of any patent annuity fees) of such Patent Right, as well as re-examinations, reissues, appeals, post grant reviews (PGR), inter partes reviews (IPR) and requests for patent term adjustments and patent term extensions with respect to such Patent Rights, together with the initiation or defense of interferences, oppositions and other similar proceedings with respect to the particular Patent Right, and any appeals therefrom. For clarification, “prosecution” and “maintenance” (including variations such as “prosecute” and “maintain”) shall not include any other enforcement actions taken with respect to a Patent Right.

(a)         Vaxart Patents and Joint Patents.

(i)         Vaxart Product-Specific Patents and Joint Patents.

(1)         Before Payment of Dynavax Election Payment. Prior to Dynavax’s payment to Vaxart of the Dynavax Election Payment, Vaxart shall have the sole right, and the obligation (except as expressly set forth below in this Section 9.2(a)(i)(1)), to prosecute and maintain Vaxart Product-Specific Patents and the first right but not the obligation to prosecute and maintain Joint Patents, in each case, by outside counsel selected by Vaxart and reasonably acceptable to Dynavax (and Dynavax hereby agrees that Vaxart’s outside counsel as of the Effective Date is acceptable to Dynavax), and Dynavax shall reimburse Vaxart for the reasonable and documented out-of-pocket costs incurred by it in such prosecution and maintenance within [***] of receipt of invoice from Vaxart. For clarity, Vaxart’s obligation to prosecute and maintain the Vaxart Product-Specific Patents under the preceding sentence shall not be construed to prohibit ordinary course prosecution actions, including amending, or agreeing to amend, the scope of a claim of a pending patent application within the Vaxart Product-Specific Patents, or filing a terminal disclaimer with respect to or abandoning a claim of a pending patent application within the Vaxart Product-Specific Patents in favor of a related claim contained in another patent application filed by Vaxart that would constitute a Vaxart Product-Specific Patent. Vaxart shall consult with Dynavax as to the prosecution and maintenance of Vaxart Product-Specific Patents and Joint Patents reasonably prior to any deadline or action with any patent office, shall furnish to Dynavax copies of all relevant drafts and documents reasonably in advance of such consultation, and shall consider in good faith Dynavax’s reasonable comments thereon. Vaxart shall keep Dynavax reasonably informed of progress with regard to the prosecution and maintenance of Vaxart Product-Specific Patents and Joint Patents and shall provide to Dynavax copies of all material patent office submissions within a reasonable amount of time following submission thereof by Vaxart. In the event that Vaxart desires to abandon or cease the prosecution or maintenance of any such Vaxart Product-Specific Patent or Joint Patent in any country, Vaxart shall provide reasonable prior written notice to Dynavax of such intention to abandon (which notice shall, to the extent possible, be given no later than [***] prior to the next deadline for any action that must be taken with respect to any such Vaxart Product-Specific Patent or Joint Patent in the relevant patent office). In such case, at Dynavax’s sole discretion, upon written notice to Vaxart, Dynavax may elect to assume responsibility for prosecution and maintenance of such Vaxart Product-Specific Patent or Joint Patent, at Dynavax’s sole cost and expense and by counsel of its own choice. For clarification, if a Vaxart Product-Specific Patent is licensed to Vaxart by a Third Party, Vaxart’s rights and obligation to prosecute and maintain such Vaxart Product-Specific Patent shall be subject to the applicable provisions of the applicable license agreement between Vaxart and such Third Party.

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(2)         After Payment of Dynavax Election Payment. From and after Dynavax’s payment to Vaxart of the Dynavax Election Payment, Dynavax shall have the first right, but not the obligation, to prosecute and maintain Vaxart Product-Specific Patents and Joint Patents, at Dynavax’s sole cost and expense and by outside counsel selected by Dynavax and reasonably acceptable to Vaxart. Dynavax shall consult with Vaxart as to the prosecution and maintenance of the Vaxart Product-Specific Patents and Joint Patents reasonably prior to any deadline or action with any patent office, shall furnish to Vaxart copies of all relevant drafts and documents reasonably in advance of such consultation, and shall consider in good faith Vaxart’s reasonable comments thereon. Dynavax shall keep Vaxart reasonably informed of progress with regard to the prosecution and maintenance of the Vaxart Product-Specific Patents and Joint Patents and shall provide to Vaxart copies of all material patent office submissions within a reasonable amount of time following submission thereof by Dynavax. In the event that Dynavax desires to abandon or cease the prosecution or maintenance of any Vaxart Product-Specific Patent or Joint Patent in any country, Dynavax shall provide reasonable prior written notice to Vaxart of such intention to abandon (which notice shall, to the extent possible, be given no later than [***] prior to the next deadline for any action that must be taken with respect to any such Vaxart Product-Specific Patent or Joint Patent in the relevant patent office). In such case, at Vaxart’s sole discretion, upon written notice to Dynavax, Vaxart may elect to assume responsibility for prosecution and maintenance of, as applicable: (A) such Vaxart Product-Specific Patent, at Vaxart’s sole cost and expense and by counsel of its own choice, and such Vaxart Product-Specific Patent shall cease to constitute a “Vaxart Patent” for purposes of this Agreement, including the License granted to Dynavax hereunder; or (B) such Joint Patent, at Vaxart’s sole cost and expense and by counsel of its own choice. For clarification, if a Vaxart Product-Specific Patent is licensed to Vaxart by a Third Party, Dynavax’s rights to prosecute and maintain such Vaxart Product-Specific Patent shall be subject to the applicable provisions of the applicable license agreement between Vaxart and such Third Party.

(ii)         Other Vaxart Patents. Vaxart shall have the sole right, but not the obligation, to prosecute and maintain Vaxart Patents other than Vaxart Product-Specific Patents, at Vaxart’s sole cost and expense and by counsel selected by Vaxart.

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(b)         Dynavax Patents. Dynavax shall have the sole right, but not the obligation, to prosecute and maintain Dynavax Patents, at Dynavax’s sole cost and expense and by counsel selected by Dynavax.

(c)         Cooperation of the Parties. Each Party agrees to cooperate fully in the preparation, filing, prosecution and maintenance of Patent Rights pursuant to this Section 9.2. Such cooperation includes, but is not limited to: (i) executing all papers and instruments, or requiring its employees or contractors, to execute such papers and instruments, so as to effectuate the ownership of Inventions set forth in Section 9.1(b), and Patent Rights Covering such Inventions, and to enable the applicable Party to apply for and to prosecute patent applications in any country as permitted by this Section 9.2, and (ii) promptly informing the other Party of any matters coming to such Party’s attention that may affect the prosecution and maintenance of any such patent applications.

9.3         Patent Enforcement.

(a)         Notice of Product Infringement. Each Party shall notify the other Party in writing within [***] (except as expressly set forth below) of becoming aware of any actual infringement or threat of infringement of any Vaxart Patent, Dynavax Patent or Joint Patent: (i) on account of a Third Party’s Manufacture, use or sale of a Third Party Competitive Product or a Biosimilar Product with respect to any Compound or Product; (ii) either, as applicable (1) a Party’s receipt of an application submitted to the FDA under subsection (k) of Section 351 of the Public Health Service Act (“PHSA”) or equivalent in any other jurisdiction pertaining to and naming a Product as a reference product (a “Biosimilar Application”) or otherwise becoming aware that such a Biosimilar Application has been filed (such as in an instance described in Section 351(l)(9)(C) of the PHSA); or (2) any certification filed in the U.S. under 21 U.S.C. § 355(b)(2) or 21 U.S.C. § 355(j)(2) or similar provisions in other jurisdictions in connection with an ANDA (an Abbreviated New Drug Application in the U.S. or a comparable application for Marketing Approval under Applicable Law in any country other than the U.S.) or other Marketing Approval Application for a Third Party Competitive Product (a “Patent Certification”); or (iii) if any Vaxart Patent, Dynavax Patent or Joint Patent is challenged in any action or proceeding (other than any oppositions, cancellations, interferences, reissue proceedings or reexaminations, which are addressed above) as invalid or unenforceable (such infringements, Biosimilar Application filings, Patent Certifications and challenges described in clauses (i) through (iii), collectively, “Product Infringement” with respect to such Compound or Product); provided, however, that: (1) within [***] of receipt or becoming aware of any Biosimilar Application, such Party shall notify the other Party so that the other Party may seek permission to view the application and related confidential information from the filer of the Biosimilar Application under Section 351(l)(1)(B)(iii) of the PHSA or equivalent in any other jurisdiction; and (2) within [***] of receipt of any Patent Certification, such Party shall notify the other Party and provide the other Party with a copy thereof. Promptly following such notification, the Parties shall confer. As used in this Section 9.3(a), a “Third Party Competitive Product” shall mean any product of a Third Party that directly competes with a Product and is approved for at least one of the same indications as such Product.

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(b)         Conduct of Patent Litigation Under the Biologics Price Competition and Innovation Act. Before Dynavax’s payment of the Dynavax Election Payment, Vaxart shall have the sole right, but not the obligation, to initiate an Infringement Action against the filer of the Biosimilar Application to enforce any Vaxart Patent or Joint Patent, including whether or not to utilize, in whole or in part, the procedures provided in Section 351 of the PHSA or equivalent in any other jurisdiction. After Dynavax’s payment of the Dynavax Election Payment, Dynavax shall have the sole right, but not the obligation, to initiate an Infringement Action against the filer of the Biosimilar Application to enforce any Vaxart Product-Specific Patent or Joint Patent, including whether or not to utilize, in whole or in part, the procedures provided in Section 351 of the PHSA or equivalent in any other jurisdiction. If Dynavax institutes any such Infringement Action to enforce any Vaxart Product-Specific Patent or Joint Patent, then Vaxart shall join as a party to such claim, suit or proceeding requiring it as a party at Dynavax’s sole cost and expense. With respect to a Vaxart Patent that is not a Vaxart Product-Specific Patent and to the extent the action is under this Section, Vaxart shall determine in its sole discretion whether any Infringement suit or other action shall be initiated shall have the sole right to initiate and undertake such action and other matters pertaining to such action.

(c)         Enforcement of Vaxart Product-Specific Patents and Joint Patents.

(i)         Before Payment of Dynavax Election Payment. Before Dynavax’s payment of the Dynavax Election Payment, Vaxart shall have the sole right to institute infringement suits or take other action under the Vaxart Product-Specific Patents and Joint Patents, in each case, to the extent the same is directed to a Product Infringement, including defense of a declaratory judgment action with respect to a potential Product Infringement, whether prior to or after the First Commercial Sale of such Product (each, an “Infringement Action”).

(ii)         After Payment of Dynavax Election Payment. After Dynavax’s payment of the Dynavax Election Payment, Dynavax shall have the first right to institute an Infringement Action under the Vaxart Product-Specific Patents and Joint Patents, in each case, to the extent the same is directed to a Product Infringement, and in each case, Dynavax shall have the right to institute such Infringement Action in the name of Vaxart or of Dynavax, or in the names of both of them. In the event that Dynavax institutes or undertakes an Infringement Action in accordance with Section 9.3(c)(ii), Vaxart shall cooperate fully with Dynavax in its efforts to protect such Patent Rights and shall agree to be a party in any suit, if required, in each case, with respect to such Infringement Action, in each case, at Dynavax’s sole expense. Further, Vaxart shall have a right, in Vaxart’s sole discretion and at Vaxart’s expense, to join or otherwise participate in such Infringement Action with legal counsel selected by Vaxart. Dynavax shall notify and keep Vaxart apprised in writing of such Infringement Action and shall consider and take into account Vaxart’s reasonable interests and requests regarding such Infringement Action. In the event that Dynavax does not institute or undertake an Infringement Action in accordance with Section 9.3(c)(ii) for a period of [***], or (if sooner) at least [***] prior to the last date such Infringement Action may be brought, Vaxart may institute or undertake and thereafter control such Infringement Action, subject to Dynavax’s prior written consent. In such event, Vaxart shall have the right, but not the obligation, to institute or undertake such suit or other appropriate Infringement Action in the name of Vaxart or of Dynavax or in the names of both of them. Dynavax shall cooperate fully with Vaxart in its efforts to protect such Patent Rights and shall agree to be a party in any suit, if required, in each case, with respect to such Infringement Action, in each case, at Vaxart’s sole expense.

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(d)         Enforcement of Vaxart Patents (Other Than Vaxart Product-Specific Patents).

(i)         Vaxart shall have the first right to institute an Infringement Action directed to a Product Infringement of Vaxart Patents that are not Vaxart Product-Specific Patents, including defense of a declaratory judgment action with respect to a potential Product Infringement, and Vaxart shall have the right to institute such Infringement Action in the name of Vaxart or of Dynavax, or in the names of both of them. Dynavax shall cooperate fully with Vaxart in its efforts to protect such Patent Rights and shall agree to be a party in any such Infringement Action, if required, at Vaxart’s sole expense. Vaxart shall notify and keep Dynavax apprised in writing of such Infringement Action and shall consider and take into account Dynavax’s reasonable interests and requests regarding such action.

(ii)         In the event that Vaxart does not institute or undertake an Infringement Action directed to a Product Infringement of Vaxart Patents other than Vaxart Product-Specific Patents in accordance with Section 9.3(d)(i) for a period of [***], or (if sooner) at least [***] prior to the last date such action may be brought, then upon Vaxart’s written consent, which may be granted or withheld in Vaxart’s sole discretion, Dynavax may institute or undertake and thereafter control such action, in the name of Vaxart or of Dynavax or in the names of both of them; provided that Vaxart’s consent shall not be required if there is no Vaxart Product-Specific Patent Covering the Product in the country in which such Product Infringement is occurring. If Vaxart consents to such action, Dynavax shall cooperate fully with Vaxart in its efforts to protect such Patent Rights and shall agree to be a party in any suit, if required, at Dynavax’s sole expense.

(e)         Enforcement of Dynavax Patents. Dynavax shall have the sole right to institute an Infringement Action directed to a Product Infringement under the Dynavax Patents [***].

(f)         Cooperation. In the event a Party brings an Infringement Action in accordance with this Section 9.3 (such Party, the “Enforcing Party”), the other Party shall cooperate fully, including, if required to bring such action, the furnishing of a power of attorney or being named as a party. The Enforcing Party shall not enter into any settlement or compromise of any action under Section 9.3 that: (i) would in any manner alter, diminish, or be in derogation of the other Party’s rights under this Agreement without the prior written consent of such other Party, which shall not be unreasonably withheld; or (ii) would impose any cost or liability on the other Party, or admit the invalidity or unenforceability of any Patent Right Controlled by the other Party, without such other Party’s prior written consent, which may be withheld in such other Party’s sole discretion.

(g)         Recoveries. Except as otherwise agreed by the Parties in connection with a cost-sharing arrangement, any recovery as a result of any action or proceeding pursuant to Section 9.3, whether by way of settlement or otherwise, shall first be used to reimburse the Enforcing Party for its documented, unreimbursed out-of-pocket costs and expenses (including court, attorneys’ and professional fees) incurred in connection with such action or proceeding and then, following payment in full of all such costs to the Enforcing Party, to reimburse the non-Enforcing Party for its documented, unreimbursed out-of-pocket costs and expenses (including court, attorneys’ and professional fees) incurred in connection with such action or proceeding. Any remainder of the recovery after reimbursement of the litigation costs and expenses of the Parties (“Remainder”) shall be retained by the Enforcing Party; provided, however, that:

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(i)         any Remainder of a recovery realized by [***]; and

(ii)         any Remainder of a recovery realized by [***].

(h)         Other Enforcement. Vaxart shall have the sole right, in its sole discretion, to enforce any Vaxart Patent that is not a Vaxart Product-Specific Patent against any infringement that is not a Product Infringement, and to retain all related recoveries. Dynavax shall have the sole right, in its sole discretion, to enforce any Dynavax Patent against any infringement that is not a Product Infringement and to retain all related recoveries. If there is any infringement of any Joint Patent that is not a Product Infringement, then the Parties shall mutually agree in good faith on a case-by-case basis whether to jointly bring and control any action or proceeding to enforce such Joint Patent, or whether one Party will bring and control any action or proceeding to enforce such Joint Patent, and, in each case, how the costs and expenses of such action or proceeding, and any recovery from such action or proceeding, will be allocated between the Parties.

9.4         Patent Term Extension. Dynavax shall have the sole discretion, after consultation with Vaxart, to determine which Vaxart Product-Specific Patents, Dynavax Patents or Joint Patents, if any, are extended with respect to any Product pursuant to U.S. Drug Price Competition and Patent Term Restoration Act of 1984, the Supplementary Certificate of Protection of Member States of the EU and other similar measures in other jurisdictions worldwide. Vaxart and Dynavax shall each cooperate and use reasonable efforts to gain any such patent term extension permitted under this Section 9.4. All filings for such extensions shall be made by the Party responsible for the prosecution of such Patent Rights. For clarity, and notwithstanding the foregoing or any other provision of this Agreement, Dynavax shall have no right to extend any Vaxart Patent that is not a Vaxart Product-Specific Patent with respect to a Product, and Vaxart shall have no obligation to allow, or consider allowing, any Vaxart Patent that is not a Vaxart Product-Specific Patent to be extended with respect to any Product.

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9.5         Infringement of Third Party Rights. Each Party shall promptly notify the other in writing of any allegation by a Third Party that Manufacture, use or sale of Product infringes or may infringe the intellectual property rights of such Third Party. Vaxart shall have the sole right to control any defense of any such claim involving alleged infringement of Third Party rights by Vaxart’s activities at its own expense and by counsel of its own choice, and Dynavax shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. Dynavax shall have the sole right to control any defense of any such claim involving alleged infringement of Third Party rights by Dynavax’s activities at its own expense and by counsel of its own choice, and Vaxart shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. Neither Party shall have the right to settle any patent infringement litigation under this Section 9.5 in a manner that diminishes the rights or interests of the other Party without the written consent of such other Party (which shall not be unreasonably withheld).

9.6         Patent Marking. Dynavax shall mark (or cause to be marked) Product marketed and sold hereunder with appropriate Vaxart Patent numbers or indicia to the extent required by Applicable Laws.

9.7         Trademarks. Dynavax shall have the sole and exclusive right to develop, clear, and select the Product Trademarks. As between the Parties, Dynavax shall own all rights in and to the Product Trademarks and shall register and maintain, in its sole discretion and at its own cost and expense, the Product Trademarks in the countries and regions in the Territory that it determines to be appropriate. Dynavax shall have the sole right, in its discretion and at its expense, to defend and enforce the Product Trademarks.

10.         Confidentiality

10.1         Confidentiality. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties, each Party agrees that, during the Term and for [***] thereafter, a Party (the “Receiving Party”) receiving or otherwise in possession of (itself or through its Affiliates) Confidential Information of the other Party (the “Disclosing Party”) or its Affiliates shall keep confidential and shall not publish or otherwise disclose and shall not use for any purpose, other than as expressly provided for in this Agreement, any such Confidential Information. The Receiving Party may use Confidential Information only to the extent expressly authorized by, or required to accomplish the purposes of, this Agreement, including exercising its rights and performing its obligations under this Agreement. The Receiving Party shall use at least the same standard of care as it uses to protect proprietary or confidential information of its own, but no less than reasonable care, to ensure that its, and its Affiliates’, employees, agents, consultants, advisors, contractors and other representatives (“Representatives”) do not disclose or make any unauthorized use of the Confidential Information. The Receiving Party will promptly notify the Disclosing Party upon discovery of any unauthorized use or disclosure of the Confidential Information. All Data generated during the Development Program Term will be considered (i) prior to Dynavax’s payment to Vaxart of the Dynavax Election Payment, the Confidential Information of both Parties, (ii) following Dynavax’s payment to Vaxart of the Dynavax Election Payment, the Confidential Information of Dynavax, and (iii) following termination (but not expiration) of this Agreement, the Confidential Information of Vaxart.

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10.2         Exceptions. Confidential Information shall not include any information that the Receiving Party can prove by competent evidence: (a) is now, or hereafter becomes, through no act or failure to act on the part of the Receiving Party in breach of this Agreement, generally known or available; (b) is known by the Receiving Party at the time of receiving such information, as evidenced by its records; (c) is hereafter furnished to the Receiving Party on a non-confidential basis by a Third Party, as a matter of right (i.e., without breaching any obligation such Third Party may have to the Disclosing Party); or (d) is independently discovered or developed by the Receiving Party, independently of the activities undertaken by the Receiving Party pursuant to this Agreement and without the use of, or reference to, the Confidential Information of the Disclosing Party, as evidenced by the Receiving Party’s contemporaneously-maintained written records. For purposes of clause (a) of this Section 10.2, no combination of elements within the Confidential Information shall be deemed to be generally known or available merely because the individual elements of such combination are generally known or available, unless the entire combination itself, or the entire principle of use or operation of such combination (if any), is generally known or available. In addition, no element within the Confidential Information shall be deemed to be generally known or available merely because it is embraced by more general information or data that is generally known or available.

10.3         Authorized Disclosure. The Receiving Party may disclose Confidential Information as expressly permitted by this Agreement, or if and to the extent such disclosure is necessary in the following instances:

(a)         filing or prosecuting Patent Rights as permitted by this Agreement;

(b)         enforcing such Party’s rights under this Agreement and performing its obligations under this Agreement;

(c)         prosecuting or defending litigation as permitted by this Agreement;

(d)         complying with applicable court orders or Applicable Laws, or the listing rules of any exchange on which such Party’s securities are traded;

(e)         in INDs, Marketing Approval Applications and other applications for Regulatory Approvals that the Receiving Party has the right to file, or holds, as expressly set forth in this Agreement;

(f)         disclosure to the Receiving Party’s Affiliates and, in the case of Dynavax, to Sublicensees and potential Sublicensees, and to the Receiving Party’s and its Affiliates’ Representatives who, in each case, need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee, or Representative agrees to be bound by terms of confidentiality and non-use at least as restrictive as those set forth in this Article 10; and

(g)         disclosure to potential Third Party investors or other financing sources in connection with due diligence or similar investigations by such Third Parties or in confidential financing documents, provided, in each case, that any such Third Party agrees to be bound by reasonable obligations of confidentiality and non-use.

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Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 10.3(c) or 10.3(d), it will, except where impracticable or legally impermissible, (i) give reasonable advance notice to the Disclosing Party of such disclosure, (ii) use efforts to secure confidential treatment of such information at least as diligent as the Receiving Party would use to protect its own confidential information, but in no event less than reasonable efforts, and (iii) cooperate with any efforts by the Disclosing Party, at the Disclosing Party’s request and expense, to secure confidential treatment of such Confidential Information. Disclosure by the Receiving Party of Confidential Information in accordance with any of the foregoing provisions of this Section 10.3 shall not, in and of itself, cause the information so disclosed to cease to be treated as Confidential Information under this Agreement, except to the extent that, by virtue of disclosure by the Receiving Party in full compliance with this Section 10.3, such information becomes generally known or available.

10.4         Confidentiality of this Agreement. Except as otherwise provided in this Article 10, each Party agrees not to disclose to any Third Party the terms of this Agreement without the prior written consent of the other Party hereto, except that each Party may disclose the terms of this Agreement that are otherwise made public as contemplated by Section 10.5 or to the extent such disclosure is permitted under Section 10.3.

10.5         Public Announcements.

(a)         No public announcement concerning this Agreement, its subject matter or the transactions described herein shall be made, either directly or indirectly, by either Party or its Affiliates, except as may be required by Applicable Law (including disclosure requirements of the U.S. Securities and Exchange Commission (“SEC”)), judicial order, or stock exchange or quotation system rule, without first obtaining the approval of the other Party and agreement upon the nature, text and timing of such announcement, which approval and agreement shall not be unreasonably withheld or delayed. The Party desiring to make a voluntary public announcement shall provide the other Party with a written copy of the proposed announcement in reasonably sufficient time (which in no event shall be less than [***]) prior to public release to allow the other Party to comment upon such announcement, prior to public release. In the case of press releases or other public communications required to be made by law, judicial order or stock exchange or quotation system rule, the Party making such press release or public announcement shall provide to the other Party a copy of the proposed press release or public announcement in written or electronic form upon such advance notice as is practicable under the circumstances for the purpose of allowing the notified Party to review and comment upon such press release or public announcement. Under such circumstances, the releasing Party shall not be obligated to delay making any such press release or public communication beyond the time when the same is required to be made. Neither Party shall be required to seek the permission of the other Party to repeat any information regarding the terms of this Agreement or any amendment hereto that has already been publicly disclosed by such Party or by the other Party in accordance with this Section 10.5(a); provided that such information remains accurate as of such time and provided the frequency and form of such disclosure are reasonable.

(b)         Each Party may make public statements regarding this Agreement in response to questions by the press, analysts, investors or those attending industry conferences or financial analyst calls, provided that any such public statement or press release: (i) is not inconsistent with prior public disclosures or public statements made in accordance with Section 10.5(a) or as permitted by Section 10.3; and (ii) does not reveal (A) information regarding the terms of this Agreement that have not previously been disclosed in accordance with Section 10.5(a) or as permitted by Section 10.3 or (B) non‑public information about the other Party.

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(c)         The Parties shall coordinate in advance with each other in connection with the filing of this Agreement (including redaction of certain provisions of this Agreement) with the SEC or other governmental agency or any stock exchange on which securities issued by a Party or its Affiliate are traded, and neither Party shall make any such filing unless the Parties have mutually agreed upon the provisions to be redacted (such agreement not to be unreasonably withheld). Each Party shall use reasonable efforts to seek and obtain confidential treatment for the provisions of this Agreement that the Parties mutually agree to redact from such filing; provided that each Party shall ultimately retain ultimate discretion to disclose such information to the SEC or any stock exchange or other governmental agency (as the case may be) as such Party determines, based on advice of legal counsel, is required to be so disclosed. Except as expressly set forth in this Article 10, neither Party (or its Affiliates) shall be obligated to consult with or obtain approval from the other Party with respect to any filings with the SEC or any stock exchange or other governmental agency where such filings do not disclose Confidential Information of the other Party.

10.6         Publication. Dynavax shall be entitled to publicly present or publish results of studies, including those carried out under the Development Program, with respect to the Compounds and Products, in its sole discretion, subject to the remainder of this Section 10.6. Dynavax will deliver a complete draft of any such proposed publication that describes the Vaxart Platform or Vaxart Technology at least [***] (or the maximum period between the completion of data collection and the deadline for submission, if less than [***]) before submitting the material to a publisher or initiating any other release. Vaxart will review any such material and give its comments to Dynavax as quickly as possible, and no later than [***] after the delivery of such draft to Vaxart. Upon reasonable request by Vaxart, Dynavax shall (a) [***], and (b) delay any submission or release for a period of up to an additional [***] (or the maximum period prior to a submission deadline, if less than [***]) to permit Vaxart to prepare and file, or have prepared and filed, any patent applications for any inventions as contemplated under this Agreement. Dynavax will ascribe authorship of any proposed publication and acknowledge the contributions of Vaxart using accepted standards used in peer-reviewed, academic journals at the time of the proposed publication. For the avoidance of doubt, Vaxart may not make any public presentations or publications of the Vaxart Technology that reference Compounds or Products without the prior review and written consent of Dynavax. Each Party recognizes that the publication of papers regarding results of and other information regarding Products, including oral presentations and abstracts, may be beneficial to both Parties, provided that such publications are subject to reasonable controls to protect Confidential Information. Accordingly (i) with respect to activities conducted prior to delivery of an Election to Proceed Notice, publications [***], and [***] shall have the right to review and comment on any material proposed for disclosure or publication by [***], such as by oral presentation, manuscript or abstract, relating to the Development or Manufacture of Compounds, and (ii) with respect to activities conducted following delivery of an Election to Proceed Notice, [***]. Before any such material is submitted for publication or disclosure (other than oral presentation materials and abstracts, which are addressed below), and subject to the foregoing, [***] shall deliver a complete copy of such material proposed for publication to [***] at least [***] prior to submitting the material to a publisher or initiating such other disclosure, and [***] shall review any such material and give its comments to [***]. With respect to oral presentation materials and abstracts, [***] shall deliver a complete copy of such material or abstracts proposed for publication to [***] at least [***] prior to the anticipated date of the submission or presentation, and [***] shall make reasonable efforts to expedite review of such materials and abstracts, and shall return such items as soon as practicable to [***] with appropriate comments, if any, but in no event later than [***] from the date of delivery to [***]. The [***] shall comply with [***]’s request to delete references to [***]’s Confidential Information in any such material and agrees to delay any submission for publication or other public disclosure for a period of up to an additional [***] for the purpose of preparing and filing appropriate patent applications.

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11.         Representations and Warranties

11.1         Mutual Representations and Warranties. Each of Dynavax and Vaxart represent and warrant to the other Party, as of the Effective Date, that:

(a)         it is duly organized and validly existing under the Applicable Laws of the jurisdiction of its incorporation or formation, as applicable, has full corporate, limited liability company or other power and authority, as applicable, to enter into this Agreement and to carry out the provisions hereof, and has sufficient facilities, experienced personnel or other capabilities (including via Affiliates or Third Parties) to enable it to perform its obligations under this Agreement;

(b)         it is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the individual executing this Agreement on its behalf has been duly authorized to do so by all requisite corporate, limited liability company or other action, as applicable; and

(c)         this Agreement is legally binding upon it and enforceable in accordance with its terms (except as the enforceability thereof may be limited by bankruptcy, bank moratorium or similar laws affecting creditors’ rights generally and laws restricting the availability of equitable remedies and may be subject to general principles of equity whether or not such enforceability is considered in a proceeding at law or in equity) and the execution, delivery and performance of this Agreement by it have been duly authorized by all necessary corporate action and do not and will not: (i) conflict with, or constitute a default or result in a breach under, any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, or violate any Applicable Laws; or (ii) require any consent or approval of its stockholders or similar corporate action (or, if any such consent or approval is required, it has already been obtained by such Party).

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11.2         Vaxart Representations and Warranties. Vaxart hereby represents and warrants to Dynavax, as of [***]:

(a)         Exhibit A attached hereto contains a true and complete list of the existing Vaxart Patents as of the Effective Date (the “Existing Vaxart Patents”), but, for clarity, Exhibit A need not include any patent application that has been abandoned, finally rejected or expired;

(b)         Exhibit B attached hereto contains a true and complete list of the existing Vaxart Product-Specific Patents as of the Effective Date (the “Existing Vaxart Product-Specific Patents”), but, for clarity, Exhibit B need not include any patent application that has been abandoned, finally rejected or expired;

(c)         All Existing Vaxart Patents are: (i) to the extent issued, subsisting and, to Vaxart’s knowledge, not invalid or unenforceable, in whole or in part, or confer a valid right to claim priority thereto; and (ii) solely and exclusively owned by Vaxart, free of any encumbrance, lien or claim of ownership by any Third Party, other than non-exclusive licenses granted to service providers in the ordinary course of business. All Existing Vaxart Patents are (A) to the extent subject to a pending application for issuance, being diligently prosecuted in the respective patent offices in which such applications have been filed in accordance with Applicable Law, and Vaxart and its Affiliates have presented all required references, documents and information to the relevant patent examiner at the relevant patent office; and (B) filed and maintained properly and correctly, and all fees applicable thereto have been paid on or before any final due date for payment, except, in each case, as would not reasonably be expected to have a material adverse effect on the Existing Vaxart Patents;

(d)         Vaxart has not assigned, transferred, conveyed or granted any license or other rights under the Vaxart Technology that would conflict with or limit the scope of any of the rights or licenses granted to Dynavax hereunder or Vaxart’s performance of its obligations hereunder;

(e)         all of Vaxart’s rights, title, and interests to the Vaxart Technology are free of any lien or security interest;

(f)         Vaxart has not granted to any Third Party or Affiliate any license, or option or other right to obtain a license, to Develop or Commercialize any Compound or Product in the Field in the Territory, other than to Third Party contractors for the purpose of performing Development or Manufacturing activities on Vaxart’s behalf;

(g)         neither Vaxart nor any of its Affiliates has been a party to any, and is not a party to any pending, litigation, and Vaxart has not received written notice of any threatened claims or litigation, in each case, seeking to invalidate or otherwise challenge the enforceability of the claims of the issued patents within the Vaxart Patents;

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(h)         neither Vaxart nor any of its Affiliates has been a party to any, and is not a party to any pending, litigation, and Vaxart has not received written notice from any Third Party, in each case, claiming that the Manufacture, use, sale, offer for sale or import of any Compound or Vaxart’s practice of the Vaxart Technology infringes or would infringe the patent or other intellectual property rights of any Third Party;

(i)         to Vaxart’s knowledge as of the Effective Date, no Third Party is infringing or misappropriating, or threatening to infringe or misappropriate, the Vaxart Technology;

(j)         all fees required to be paid by Vaxart in any jurisdiction where a Vaxart Patent has issued in order to maintain such Vaxart Patent in such jurisdiction have been timely paid and the Vaxart Patents that have issued are subsisting and, to Vaxart’s knowledge, valid and enforceable;

(k)         Vaxart has obtained, or caused all Affiliates of Vaxart, as applicable, to obtain, assignments from the inventors of any Vaxart Technology who were employees of Vaxart or any Affiliate of Vaxart at the time of the invention, of all inventorship rights to such Vaxart Technology, and all such assignments are valid and enforceable;

(l)         all tangible or recorded information and data provided by or on behalf of Vaxart to Dynavax related to Compounds on or before the Effective Date in contemplation of this Agreement was and is true, accurate and complete in all material respects, and Vaxart has not failed to disclose, or failed to cause to be disclosed, any such information or data related to Compounds in its possession and Control and that was generated or obtained on or before the Effective Date that would cause the information and data that has been disclosed to be misleading in any material respect;

(m)         neither Vaxart nor any of its Affiliates is a party to any legal action, suit or proceeding relating to the Vaxart Technology or any Compound or Product, and neither Vaxart nor any of its Affiliates has received written notice of any threatened legal action, suit or proceeding relating to the Vaxart Technology or any Compound or Product;

(n)         there are no claims, judgments, or settlements against or pending with respect to the Vaxart Technology, or amounts with respect thereto, owed by Vaxart or any Affiliate of Vaxart, and neither Vaxart nor any of its Affiliates has received written notice threatening any such claims;

(o)         neither Vaxart nor any of its Affiliates is or has been debarred or suspended under 21 U.S.C. § 335(a) or § 335(b) or any foreign equivalent thereof, or is the subject of a conviction described in such section or any foreign equivalent thereof;

(p)         none of the Vaxart Technology is licensed to Vaxart or any Affiliate of Vaxart by a Third Party, and no Third Party has any rights, title or interests in or to, or any license under, any of the Vaxart Technology that would conflict with the rights and licenses granted to Dynavax hereunder;

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(q)         [***]:

(i)         [***]:

(1)         [***]

(2)         [***]

(ii)         [***];

(r)        [***];

(s)        [***];

(t)         [***];

(u)         [***];

(v)         [***]; and

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(w)         [***].

11.3         Dynavax Representations and Warranties. Dynavax represents and warrants to Vaxart, as of the Effective Date, that neither Dynavax nor any of its Affiliates has been debarred or suspended under 21 U.S.C. § 335(a) or § 335(b) or any foreign equivalent thereof, or is the subject of a conviction described in such section or any foreign equivalent thereof.

11.4         Mutual Covenants. In addition to any covenants made by it elsewhere in this Agreement, each Party hereby covenants to the other Party that:

(a)         such Party will, and will ensure that its Affiliates and Third Party contractors, obtain written agreements from any and all Persons involved in or performing any Development Program Activities by or on behalf of such Party that assign, to the extent legally permissible (or exclusively license, with a right to grant sublicenses), such Persons’ rights, title and interests in and to any Inventions or other intellectual property developed or invented in the performance of such activities that specifically relate to the Compounds or Products, or their use, Manufacture or sale, to such Party prior to any such Person performing such activities; provided that if a Party engages a CRO or clinical trial site for the conduct of Clinical Trials of Compounds or Products hereunder, then the obligations regarding ownership of intellectual property, including Patent Rights, or of confidentiality and non-use of confidential information set forth in the agreement between such Party and such Person may be those customarily entered into with such a Third Party by such Party for the Development and Commercialization of its own valuable products.

(b)         such Party will not assign, in whole or in part, any of its rights, title or interests in and to the Vaxart Technology (in the case of Vaxart) or the Dynavax Technology (in the case of Dynavax); provided that such Party may assign all of its rights, title and interests in and to the Vaxart Technology (in the case of Vaxart) or the Dynavax Technology (in the case of Dynavax) to any permitted assignee of this Agreement as set forth in Section 15.6, if such Vaxart Technology (in the case of Vaxart) or Dynavax Technology (in the case of Dynavax) is assigned together to such assignee;

(c)         in the event that such Party becomes aware that it or any of its Affiliates has been debarred, suspended or is the subject of a conviction described in 21 U.S.C. § 335(a) or § 335(b) or any foreign equivalent thereof, or if any action, suit, claim, investigation, or legal or administrative proceeding is pending or, to its actual knowledge, is threatened, relating to such debarment, suspension or conviction, such Party will immediately notify the other Party in writing, in which case the other Party may terminate this Agreement immediately upon written notice to the other Party;

(d)         in the event that such Party becomes aware that any Person that is performing activities hereunder on its behalf has been debarred, suspended or is the subject of a conviction described in 21 U.S.C. § 335(a) or § 335(b) or any foreign equivalent thereof, or if any action, suit, claim, investigation, or legal or administrative proceeding is pending or, to its actual knowledge, is threatened, relating to such debarment, suspension or conviction, such Party will immediately notify the other Party in writing and such Party will cease, or cause its Affiliate to cease (as applicable), employing, contracting with, or retaining any such Person to perform any services relating to Product;

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(e)         any payments made to health care practitioners (HCPs) under or in connection with this Agreement will be on arm’s length terms at no greater than fair market value;

(f)         neither such Party nor any of its Affiliates will, in connection with the exercise of such Party’s rights or performance of its obligations under this Agreement, directly or indirectly through Affiliates or Third Parties, pay, promise or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize the giving of anything of value to a public official or entity or other Person for purpose of obtaining or retaining business for or with, or directing business to, any Person, including such Party and its Affiliates, nor will such Party or any of its Affiliates directly or indirectly promise, offer or provide any corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other illegal or unethical benefit to a public official or entity or any other Person in connection with the exercise of such Party’s rights or performance of such Party’s obligations under this Agreement;

(g)         neither such Party nor any of its Affiliates (or any of their respective employees and contractors), in connection with the exercise of such Party’s rights or performance of such Party’s obligations under this Agreement, shall cause the other Party to be in violation of Anti-Corruption Laws; and

(h)         such Party shall immediately notify the other Party if such Party has any information or suspicion that there may be a violation of Anti-Corruption Laws in connection with the exercise of such Party’s rights or performance of such Party’s obligations under this Agreement.

11.5         Vaxart Covenants.

(a)         During the Term, Vaxart shall not grant any Third Party any license or other right with respect to any Compound, Product or Vaxart Technology in derogation of the licenses and rights expressly granted to Dynavax hereunder.

(b)         During the Term, Vaxart will not, and will cause all Affiliates of Vaxart not to incur or permit to exist, with respect to any Vaxart Technology, any lien, encumbrance, charge, security interest, mortgage, liability or other restriction (including in connection with any indebtedness) that would conflict with any of the rights or licenses granted to Dynavax hereunder, and without limiting the foregoing, in the event that Vaxart or any of its Affiliates incurs or permits to exist, with respect to its interest in any Vaxart Technology, any such lien or security interest, Vaxart shall cause the holder of such lien or security interest to enter into a non-disturbance or similar agreement with respect to such interest in such Vaxart Technology and this Agreement that provides it shall not disturb Dynavax’s interest in such Vaxart Technology in the event of foreclosure of such lien or security interest for so long as Dynavax is in compliance with the terms and conditions of this Agreement.

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(c)         Vaxart will not [***], in a manner that would conflict with licenses and rights expressly granted to Dynavax under this Agreement or the obligations of Vaxart under this Agreement or materially adversely impact the rights and licenses granted to Dynavax under this Agreement.

(d)         [***].

(e)         [***].

(f)         [***].

(g)         [***] If Dynavax [***], Vaxart shall: [***]

(i)         as soon as practicable, but in any event within [***] after the end of each Calendar Quarter:

(1)         an unaudited balance sheet as of the end of such Calendar Quarter,

(2)         unaudited statements of income and cash flows for such Calendar Quarter,

(3)         an unaudited statement of stockholders’ equity for such period, and

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(4)         a detailed trial balance as of the end of such Calendar Quarter, all prepared in accordance with applicable Accounting Standards, consistently applied, except that such financial statements may:

a.         be subject to year-end audit adjustments; and

b.         not contain all notes thereto that may be required in accordance with applicable Accounting Standards;

and thereafter shall promptly provide such other information as Dynavax may reasonably request;

(ii)         as soon as practicable, but in any event within [***] after the end of each Calendar Year:

(1)         an audited balance sheet as of the end of such Calendar Year;

(2)         audited statements of income and cash flows for such Calendar Year;

(3)         an audited statement of stockholders’ equity for such Calendar Year; and

(4)         a detailed trial balance as of the end of such Calendar Year, together with related footnotes all prepared in accordance with applicable Accounting Standards, consistently applied, and audited and certified by a nationally recognized independent public accounting firm;

(iii)         on or prior to [***] of each Calendar Year, Vaxart shall perform a 409A analysis of the fair value of Vaxart’s stock as of [***] of such year as prepared by an independent valuation expert; provided that if Vaxart has not performed such 409A analysis independent of this Agreement, Dynavax shall promptly reimburse Vaxart for its reasonable costs in performing (including engaging an outside firm to perform) such 409A analysis; and

(iv)         any other information or agreements requested by Dynavax and reasonably necessary for the purposes of its quarterly and annual financial statements.

11.6         Disclaimer. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, THE TECHNOLOGY AND INTELLECTUAL PROPERTY RIGHTS PROVIDED BY EACH PARTY HEREUNDER ARE PROVIDED “AS IS.” EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND, AND EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES. VAXART EXPRESSLY ACKNOWLEDGES AND AGREES THAT, DESPITE THE EFFORTS AND OBLIGATIONS REQUIRED BY THIS AGREEMENT, THE DEVELOPMENT MILESTONE EVENTS, THE REGULATORY MILESTONE EVENTS, THE SALES MILESTONE EVENTS, OR NET SALES OF PRODUCT MAY NOT BE ACHIEVED AND VAXART, IN THAT CASE, WOULD NOT BE ENTITLED TO RECEIVE THE DEVELOPMENT MILESTONE PAYMENTS, REGULATORY MILESTONE PAYMENTS, SALES MILESTONE PAYMENTS OR ROYALTIES, AS THE CASE MAY BE, CORRESPONDING TO SUCH UNACHIEVED EVENTS OR UNACHIEVED NET SALES, AS THE CASE MAY BE. IN ADDITION, EACH PARTY EXPRESSLY ACKNOWLEDGES THAT, DESPITE THE EFFORTS AND OBLIGATIONS REQUIRED BY THIS AGREEMENT, THE PARTIES MAY BE UNABLE TO MEET EXPECTED OR INTENDED TIMELINES FOR THE DEVELOPMENT OR COMMERCIALIZATION OF COMPOUNDS OR PRODUCTS.

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11.7         Limitation of Liability. EXCEPT IN THE CASE OF BREACH OF ARTICLE 10, A PARTY’S INDEMNIFICATION OBLIGATIONS UNDER ARTICLE 13, OR A PARTY’S NEGLIGENCE, WILFUL MISCONDUCT OR FRAUD, NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY OR PUNITIVE DAMAGES, INCLUDING ANY LOST PROFITS OR REVENUE OF ANY KIND EVEN IF DEEMED DIRECT DAMAGES, IN CONNECTION WITH THIS AGREEMENT, REGARDLESS OF WHETHER A PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

12.         Term and Termination

12.1         Term. The term of this Agreement (the “Term”) shall commence on the Effective Date and, unless earlier terminated pursuant to Section 11.4(c) or this Article 12, shall expire upon the expiration of the last-to-expire Royalty Term with respect to all Products in all countries.

12.2         Termination for Material Breach.

(a)         Either Party shall have the right to terminate this Agreement in its entirety (except as expressly set forth below in this Section 12.2(a) or in Section 12.2(b)) upon written notice to the other Party if such other Party is in material breach of this Agreement and has not cured such breach within [***] (or [***] with respect to any payment breach) after notice from the first Party requesting cure of the breach. Any such termination shall become effective at the end of such period unless the breaching Party has cured such breach prior to the end of such period. Any right to terminate under this Section 12.2(a) shall be stayed and the cure period tolled in the event that, during any cure period, the Party alleged to have been in material breach shall have initiated dispute resolution in accordance with Article 14 with respect to the alleged breach, which stay and tolling shall continue until such dispute has been resolved in accordance with Article 14.

(b)         For clarity, in the event of material breach of this Agreement by Vaxart that is not cured within the applicable notice period set forth in Section 12.2(a), Dynavax, at its sole discretion, may either: (i) terminate this Agreement in accordance with Section 12.2(a) (in addition to pursuing any remedy that may be available to Dynavax at law or in equity as a result of Vaxart’s breach of this Agreement); or (ii) elect (A) not to terminate this Agreement, (B) to retain the License, subject to all terms and conditions of this Agreement, and (C) pursue any remedy that may be available to Dynavax at law or in equity as a result of Vaxart’s breach of this Agreement, without prejudice to Dynavax’s right to terminate this Agreement at a later date pursuant to Section 12.2(a) (for that uncured material breach or any other uncured material breach of this Agreement by Vaxart).

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12.3         Termination for Bankruptcy. Either Party may terminate this Agreement in its entirety upon written notice to the other Party if the other Party becomes subject to an Insolvency Proceeding.

12.4         Termination for Failure to Deliver Election to Proceed Notice. Vaxart shall have the right to terminate this Agreement in its entirety upon written notice to Dynavax if Dynavax fails to deliver the Election to Proceed Notice to Vaxart in accordance with Section 4.7(b) prior to expiration of the Election Period.

12.5         Termination by Dynavax for Safety Concern. Dynavax may terminate this Agreement by written notice to Vaxart in the event that Dynavax determines, in its reasonable and good-faith judgment, that continued Development or Commercialization of a Product would be unethical or unreasonable due to a Material Safety Issue. Such termination shall be effective immediately upon Dynavax’s written notice to Vaxart.

12.6         Discretionary Termination by Dynavax. Dynavax may unilaterally terminate this Agreement for any reason upon [***]’ written notice to Vaxart.

12.7         Effect of Expiration or Termination.

(a)         Expiration. Upon expiration (but not earlier termination) of this Agreement pursuant to Section 12.1: (i) the License shall automatically become fully-paid, royalty-free, irrevocable and perpetual; and (ii) all other rights and obligations of the Parties under this Agreement shall terminate, except as provided in Section 12.8.

(b)         Termination by Dynavax Pursuant to Section 12.2(a) or 12.5. Solely in the event of termination of this Agreement by Dynavax pursuant to Section 12.2(a) or Section 12.5: (i) the License shall automatically terminate and revert to Vaxart; and (ii) all other rights and obligations of the Parties under this Agreement shall terminate, except as provided elsewhere in this Section 12.7 or in Section 12.8.

(c)         Termination by Vaxart Pursuant to Section 12.2(a) or 12.4 or by Dynavax Pursuant to Section 12.6. Solely in the event of termination of this Agreement by Vaxart pursuant to Section 12.2(a) or Section 12.4, or termination of this Agreement by Dynavax pursuant to Section 12.6, the following provisions shall apply:

(i)         [***], the License shall automatically terminate and revert to Vaxart, except that the License shall survive on a non‑exclusive basis solely for the purpose and duration of any wind-down activities to be conducted by Dynavax in accordance with the remainder of this Section 12.7(c);

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(ii)         Dynavax shall take such actions as reasonably necessary to [***]; provided, however, that [***]; and *provided, further,*that [***];

(iii)         As promptly as practicable (and in any event within [***]) after such termination, [***];

(iv)         Without limiting the generality of Section 12.7(c)(ii), at Vaxart’s request, Dynavax shall promptly transfer all safety data from Development or Commercialization of any Product in the possession or Control of Dynavax or its Affiliates to Vaxart, and Vaxart shall accept such transfer of such data. Vaxart shall assume all pharmacovigilance responsibility for such Products, including but not limited to serious adverse event and pregnancy reporting, in accordance with Applicable Law;

(v)         Dynavax shall, at Vaxart’s option, either: (i) promptly wind-down any ongoing Development activities with respect to a Compound or Product in the Field in the Territory in an orderly fashion; or (ii) promptly transition such activities to Vaxart or its designee, in which event Vaxart shall assume any and all liability for such activities arising after the completion of such transition; in either case (clause (i) or (ii)), with due regard for patient safety and in compliance with all Applicable Laws and international guidelines. In addition, Dynavax shall, as directed by Vaxart, assign to Vaxart or its designee any or all clinical trial agreements or commercial agreements with respect to Product (or to the extent not so assignable, take all reasonable actions to make available to Vaxart or its designee the benefits of such agreements);

(vi)         Dynavax shall reasonably cooperate, at Vaxart’s request and expense, with Vaxart and its designee(s) to facilitate a smooth, orderly and prompt transition of any or all ongoing Development and Manufacturing activities with respect to Product to Vaxart or its designee(s);

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(vii)         Vaxart shall have the first right, but not the obligation, to prosecute and maintain all Joint Patents, at Vaxart’s sole expense and by counsel selected by Vaxart. In the event that, after the effective date of such termination, Vaxart desires to abandon or cease prosecution or maintenance of any Joint Patent, Vaxart shall provide written notice to Dynavax of such intention to abandon promptly after Vaxart makes such determination (which notice shall be given no later than [***] prior to the next deadline for any action that must be taken with respect to such Joint Patent in the relevant patent office). In such case, Dynavax shall have the right, in its discretion, exercisable upon written notice to Vaxart, to assume responsibility for prosecution and maintenance of such Joint Patent, at its sole cost and expense and by counsel of its own choice. Dynavax will cooperate with Vaxart and provide Vaxart with reasonable assistance with such prosecution and maintenance activities with respect to Joint Patents;

(viii)         Vaxart shall have the first right, but not the obligation, to bring and control any action or proceeding to enforce any Joint Patent with respect to Product Infringement, at its own expense and by counsel of its own choice. If Vaxart fails to bring and control any such action or proceeding within (A) [***] following the notice of alleged infringement, or (B) [***] before the time limit, if any, set forth in the Applicable Laws for the filing of such actions, whichever comes first, then Dynavax shall have the right to bring and control any such action, at its own expense and by counsel of its own choice, and Vaxart shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. In the event a Party brings an infringement action in accordance with this paragraph, the other Party shall cooperate fully, including, if required to bring such action, the furnishing of a power of attorney or being named as a party. The Party that brings such infringement action shall not enter into any settlement or compromise of any action under this paragraph: (1) in a manner that would diminish the rights or interests of the other Party without the written consent of such other Party, which shall not be unreasonably withheld; or (2) that would impose any cost or liability on the other Party, or admit the invalidity or unenforceability of any Patent Right Controlled by the other Party, without such other Party’s prior written consent, which may be withheld in such other Party’s sole discretion. Except as otherwise agreed by the Parties in connection with a cost-sharing arrangement, any recovery as a result of any action or proceeding pursuant to this paragraph, whether by way of settlement or otherwise, shall first be used first to reimburse Party that brought and controlled such action or proceeding for its documented, out-of-pocket costs and expenses (including court, attorneys’ and professional fees) incurred in connection with such action or proceeding, and then to reimburse the other Party for its documented, out-of-pocket costs and expenses (including court, attorneys’ and professional fees) incurred in connection with such action or proceeding (to the extent not previously reimbursed by the Enforcing Party), and any remainder of the recovery after reimbursement of the litigation costs and expenses of the Parties, shall be retained by the Enforcing Party. In the case of infringement of a Joint Patent other than Product Infringement, the Parties shall mutually agree in good faith on a case-by-case basis whether to jointly bring and control any action or proceeding to enforce such Joint Patent, or whether one Party will bring and control any action or proceeding to enforce such Joint Patent, and, in each case, how the costs and expenses of such action or proceeding, and any recovery from such action or proceeding, will be allocated between the Parties;

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(ix)         Dynavax shall assign to Vaxart all right, title and interest in and to all Product Trademarks for Products, including all trademark applications and registrations and all goodwill therein, and all Product Domain Names for Products. For clarity, Product Trademarks do not include the Dynavax Housemarks. Vaxart shall be solely responsible for all costs and expenses related to the assignments, including recordation of the same. For a period of up to [***] after the termination date, at Vaxart’s cost and expense, (1) Dynavax shall provide to Vaxart the necessary information to permit Vaxart to effect and perfect the transfer of the applications and registrations of the Product Trademarks and Product Domain Names and (2) Dynavax shall reasonably cooperate with Vaxart in executing appropriate documents to effectuate the transfer or assignment of the Product Trademarks and Product Domain Names that are in the name of Dynavax or any of its Affiliates. After such period, Dynavax shall have no further obligation with respect to the matters covered by this Section 12.7(c)(ix);

(x)         Subject to Section 12.7(c)(xi), Vaxart shall have the right, but not the obligation, to purchase from Dynavax any or all usable inventory of Compound and Product in Dynavax’s or its Affiliates’ possession as of the date of termination at a supply price equal to Dynavax’s reasonable internal and Third Party costs incurred in Manufacturing or acquisition of (and to the extent directly attributable to) such inventory, determined in accordance with Dynavax’s accounting policies that are in accordance with applicable Accounting Standards, consistently applied. Any packaging, transport, insurance and other costs relating to delivery shall be at Vaxart’s expense;

(xi)         Dynavax will have the right to sell or otherwise dispose of any inventory of any Product on hand at the time of such termination or in the process of Manufacturing for a period of [***] following the effective date of termination; provided that any revenue obtained from such disposal will be treated as Net Sales and the provisions of Article 7 will apply to such Net Sales; and

(xii)         Dynavax shall, at Vaxart’s request, use Commercially Reasonable Efforts (provided that, for clarity, such efforts shall not require Dynavax to make any payments unless Vaxart agrees in writing to reimburse Dynavax for such payments) to facilitate negotiations between Vaxart and any of Dynavax’s Third Party contractors performing any ongoing Development, Manufacturing, or Commercialization activities with respect to any Compound or Product, or, at Vaxart’s reasonable request, and to the extent permissible under any agreement between Dynavax and such Third Party subcontractor, provided that such agreement relates only to Compound or Product and subject to Vaxart’s agreement to bear any associated costs, assign such agreement related solely to Compound or Product to Vaxart.

12.8         Accrued Obligations; Survival. Neither expiration nor termination of this Agreement shall relieve either Party of any obligation or liability accruing prior to such expiration or termination, nor shall expiration or termination of this Agreement preclude either Party from pursuing all rights and remedies it may have under this Agreement, at law or in equity, with respect to breach of this Agreement. The Parties’ rights and obligations under Article 1 (Definitions), Section 2.2 (Sublicenses, solely with respect to applicable licenses hereunder that survive expiration or termination of this Agreement), Section 2.5 (No Implied Licenses), Section 4.5(f) (Audits, to the extent necessary for a Party to comply with Applicable Law, or, in the case of Vaxart, to the extent necessary to exercise any licenses and rights granted to it under Section 12.7(c), if applicable), Section 4.8 (Records, to the extent necessary for a Party to comply with Applicable Law, or, in the case of Vaxart, to the extent necessary to exercise any licenses and rights granted to it under Section 12.7(c), if applicable), Section 5.5 (Records), Article 7 (Financial Terms, to the extent that any payment accrued prior to expiration or termination of this Agreement or accrues after termination of this Agreement pursuant to Section 12.7(c)(xi)), Article 8 (Payment; Reports; Audits, to the extent that any payment accrued prior to expiration or termination of this Agreement or accrues after termination of this Agreement pursuant to Section 12.7(c)(xi)), Section 9.1 (Ownership), Section 10.1 (Confidentiality), Section 10.2 (Exceptions), Section 10.3 (Authorized Disclosure), Section 10.4 (Confidentiality of this Agreement), Section 10.6 (Publication), Section 11.6 (Disclaimer), Section 11.7 (Limitation of Liability), Section 12.7 (Effect of Expiration or Termination), this Section 12.8 (Accrued Obligations; Survival), Article 13 (Indemnification), Article 14 (Dispute Resolution) and Article 15 (Miscellaneous) of this Agreement shall survive expiration or termination of this Agreement.

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13.         Indemnification

13.1         By Dynavax. Subject to Section 13.3, Dynavax will indemnify, defend and hold harmless Vaxart and its Affiliates and its and their respective directors, officers, employees and agents (each, a “Vaxart Indemnitee”) from and against any and all costs, fees, damages, liabilities, expenses or losses, including reasonable legal expense and attorneys’ fees (collectively, “Losses”) to which any Vaxart Indemnitee may become subject as a result of any claim, demand, action or other proceeding, in each case, by any Third Party (“Claim”) to the extent such Losses arise directly or indirectly out of: (a) the practice by Dynavax or any of its Affiliates or Sublicensees of the License; (b) the Development, Manufacture or Commercialization of Compounds or Products by or on behalf of Dynavax or any of its Affiliates or Sublicensees; (c) the breach by Dynavax of any provision of this Agreement (including any warranty, representation, covenant or agreement made by Dynavax herein); or (d) the negligence, willful misconduct, or fraud of any Dynavax Indemnitee (defined below), except, in each case (clauses (a)-(d)), to the extent such Losses result from the negligence, willful misconduct, or fraud of any Vaxart Indemnitee or the breach by Vaxart of any provision of this Agreement (including any warranty, representation, covenant or agreement made by Vaxart herein).

13.2         By Vaxart. Subject to Section 13.3, Vaxart will indemnify, defend and hold harmless Dynavax and its Affiliates and its and their respective directors, officers, employees and agents (each, a “Dynavax Indemnitee”) from and against any and all Losses to which any Dynavax Indemnitee may become subject as a result of any Claim to the extent such Losses arise directly or indirectly out of: (a) the Development, Manufacture or Commercialization of any Compounds or Products by or on behalf of Vaxart or any of its Affiliates or licensees or sublicensees prior to the Effective Date; (b) the breach by Vaxart of any provision of this Agreement (including any warranty, representation, covenant or agreement made by Vaxart herein); (c) the negligence, willful misconduct or fraud of any Vaxart Indemnitee; or (d) in the event of termination of this Agreement, the Development, Manufacture or Commercialization of Compounds or Products by or on behalf of Vaxart or any of its Affiliates, licensees or sublicensees after such termination of this Agreement, except, in each case (clauses (a)-(d)), to the extent such Losses result from the negligence, willful misconduct, or fraud of any Dynavax Indemnitee or the breach by Dynavax of any provision of this Agreement (including any warranty, representation, covenant or agreement made by Dynavax herein).

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13.3         Procedure. In the event that a Party (the “Indemnified Party”) seeks indemnification under Section 13.1 or 13.2, the Indemnified Party shall: (a) inform the other Party (the “Indemnifying Party”) of a Claim [***] after it receives notice of the Claim (it being understood and agreed, however, that the failure by an Indemnified Party to give notice of a Claim as provided in this Section 13.3 shall not relieve the Indemnifying Party of its indemnification obligation under this Agreement except and only to the extent that such Indemnifying Party is actually damaged as a result of such failure to give notice); (b) permit the Indemnifying Party to assume direction and control of the defense of the Claim (including the right to settle the Claim solely for monetary consideration); and (c) cooperate as requested (at the expense of the Indemnifying Party) in the defense of the Claim. If the Indemnifying Party does not assume control of such defense within [***] after receiving notice of the Claim from the Indemnified Party, the Indemnified Party may control such defense and, without limiting the Indemnifying Party’s indemnification obligations, the Indemnifying Party shall reimburse the Indemnified Party for all reasonable and documented costs, including reasonable attorney fees, incurred by the Indemnified Party in defending itself within [***] after receipt of any invoice therefor from the Indemnified Party. The Party not controlling such defense may participate therein at its own expense. The Party controlling such defense shall keep the other Party advised of the status of such Claim and the defense thereof and shall consider recommendations made by the other Party with respect thereto. The Indemnified Party shall not agree to any settlement of such Claim without the prior written consent of the Indemnifying Party. The Indemnifying Party shall not agree to any settlement of such Claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Indemnified Party from all liability with respect thereto, that imposes any liability or obligation on the Indemnified Party or that acknowledges fault by the Indemnified Party without the prior written consent of the Indemnified Party.

13.4         Insurance. During the Term, each Party shall maintain such types and amounts of liability insurance (and with respect to Dynavax, all such insurance may be self-insurance) as is normal and customary in the industry generally for similarly situated parties and adequate to cover its obligations under this Agreement, and each Party will upon reasonable request from time-to-time provide the other Party with a certificate of insurance in that regard, along with any amendments and revisions thereto existing and relevant at the time of such request. Vaxart represents and warrants to Dynavax that, as of the Effective Date, Vaxart maintains the types and amounts of insurance covering its activities with respect to Compounds and Products specified in Exhibit F.

14.         Dispute Resolution

14.1         Exclusive Dispute Resolution Mechanism. The Parties agree that, except as expressly set forth in Article 3 or Section 4.9 or 14.4, the procedures set forth in this Article 14 shall be the exclusive mechanism for resolving any dispute, controversy, or claim between the Parties that may arise from time to time pursuant to, arising out of or in connection with this Agreement, including any Party’s rights or obligations hereunder or any questions regarding the formation, existence, validity, enforceability, performance, interpretation, tort, breach or termination hereof (collectively, “Disputes”) that cannot be resolved through good faith negotiation between the Parties.

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14.2         Resolution by Senior Executives. In the event of any Dispute, the Parties shall first attempt in good faith to resolve such Dispute by negotiation and consultation. In the event that such Dispute is not resolved through such negotiation within [***] after either Party’s request, either Party may, by written notice to the other Party, refer the Dispute for attempted resolution by good faith negotiation between the Senior Executives within [***] after such notice is received. Except as set forth in Section 14.4, if any Dispute is not resolved by the Senior Executives within the above [***] period (or such other period of time as mutually agreed by the Senior Executives), either Party may, in its sole discretion, seek resolution of such Dispute in accordance with Section 14.3.

14.3         Arbitration.

(a)         With respect to any Disputes that are not resolved by the Senior Executives in accordance with Section 14.2, either Party shall have the right to submit the Dispute for resolution in arbitration administered by the American Arbitration Association (“AAA”) pursuant to its then current Commercial Arbitration Rules (“AAA Rules”), except where they conflict with this Section 14.3, in which case this Section 14.3 shall control.

(b)         The arbitration shall be conducted in accordance with the AAA Rules by an arbitral tribunal of three (3) independent and impartial arbitrators; provided that: (i) no such arbitrator shall be current or former employee or director, or current stockholder, of either Party, any of their respective Affiliates or any Sublicensee; (ii) each arbitrator shall have experience and familiarity with commercial licensing practices in the pharmaceutical and biotechnology industries; and (iii) each arbitrator shall be a lawyer with at least [***]’ experience with a law firm or corporate law department of over [***] lawyers or who was a judge of a court of general jurisdiction. Each Party shall be entitled to nominate one arbitrator within [***] after the initiation of the arbitration. The other Party may object to the nomination on grounds of bias, lack of subject matter experience, or any other legitimate grounds. AAA will be the final decision maker if there is a dispute over the objection. Once the Party-nominated arbitrators are established, the two (2) Party-nominated arbitrators shall nominate a third arbitrator, who shall act as chairperson, within [***] after the appointment of the second arbitrator. If any of the three (3) arbitrators are not selected within the time period prescribed above, then the AAA shall appoint the arbitrators in accordance with the Rules. Each arbitrator shall abide by the Code of Ethics for Arbitrators in Commercial Disputes.

(c)         The seat, or legal place, of arbitration shall be New York, New York, and the language used in any such proceeding shall be English.

(d)         Any arbitration conducted pursuant to the terms of this Agreement shall be governed by the Federal Arbitration Act (9 U.S.C. §§ 1 et. seq.). The arbitrator(s) shall be guided, but not bound, by the CPR Protocol on Disclosure of Documents and Presentation of Witnesses in Commercial Arbitration (www.cpradr.org) (“Protocol”). The Parties will attempt to agree on modes of document disclosure, electronic discovery, witness presentation, etc. within the parameters of the Protocol. If the Parties cannot agree on discovery and presentation issues, the arbitrator(s) shall decide on presentation modes and provide for discovery within the Protocol, understanding that the Parties contemplate reasonable discovery. The arbitral tribunal shall, in rendering an award, apply the substantive law of the State of New York, USA, without giving effect to any conflicts of law provisions thereof that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction, and without giving effect to any of its rules or laws relating to arbitration. The award shall include a written statement describing the essential findings and conclusions upon which the award is based, including the calculation of any damages awarded. The arbitral tribunal’s authority to award special, incidental, consequential or punitive damages or lost profits shall be subject to the limitation set forth in Section 11.7, except to the extent the substantive laws of the State of New York, USA, do not permit such limitation.

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(e)         Except to the extent necessary to confirm or enforce an award or as may be required by Applicable Law, neither a Party nor the arbitral tribunal may disclose the existence, content, or results of an arbitration without the prior written consent of both Parties.

(f)         The award rendered by the arbitral tribunal shall be final, binding and non‑appealable (subject only to the Parties’ right to request correction of any errors in computation, clerical or typographical errors, or other errors of a similar nature, and the arbitral tribunal’s right to make any such correction on its own initiative, in each case, in accordance with the AAA Rules), and judgment upon the award may be entered in any court of competent jurisdiction.

(g)         Each Party shall bear its own costs and attorney’s fees, and the Parties shall equally bear the fees, costs, and expenses of the arbitrators and the arbitration proceedings, including costs and expenses of translators for the arbitration proceedings; provided, however, that the arbitrators may exercise discretion to award arbitration costs and translation costs, excluding attorney’s fees, to the prevailing Party.

(h)         All activities undertaken by the arbitrator(s) or the Parties pursuant to this Section 14.3 shall be conducted subject to obligations of confidentiality and non-use no less restrictive than those set forth in Article 10. Further, the Parties acknowledge and agree that their respective conduct during the course of the arbitration, their respective statements and all information exchanged in connection with the arbitration, and the contents of the arbitration and any information produced thereunder is Confidential Information of the applicable Party and subject to the provisions of Article 10 (provided that, for clarity, disclosure by a Party is permitted to the extent permitted pursuant to Article 10, including in connection with actions to enforce or challenge an arbitral award as provided therein).

14.4         Injunctive Relief; Court Actions. Notwithstanding the foregoing in this Article 14, nothing contained in this Agreement shall in any way limit or preclude a Party from, at any time, seeking or obtaining equitable relief hereunder, whether preliminary or permanent, including a temporary or permanent restraining order, preliminary or permanent injunction, specific performance or any other form of equitable relief, from any court of competent jurisdiction if necessary to protect the interests of such Party. Either Party may apply to the arbitral tribunal for interim injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved. Each Party agrees that any breach or threatened breach of Articles 9 or 10 may cause irreparable damage to other Party for which recovery of damages would be inadequate, and that such other Party shall be entitled to seek timely injunctive relief with respect to such breach, without the need to show irreparable harm or the inadequacy of monetary damages as a remedy, as well as any further relief that may be granted by a court of competent jurisdiction. In addition, either Party may bring an action in any court of competent jurisdiction to resolve disputes pertaining to the scope, construction, validity, and enforceability of any patent, and no such claim shall be subject to arbitration pursuant to Section 14.3.

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15.         Miscellaneous

15.1         Rights Upon Bankruptcy. The Parties acknowledge and agree that all rights and licenses granted under or pursuant to this Agreement to Dynavax or Dynavax are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code and other similar foreign laws, licenses of rights to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code or other similar foreign laws. The Parties agree that the Parties shall retain and may fully exercise all of their rights and elections under the U.S. Bankruptcy Code (or any comparable provision of the laws applicable to bankruptcies or insolvencies), and other similar foreign laws. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against a Party under the U.S. Bankruptcy Code, the non‑debtor Party shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property and the same, which, if not already in the non‑debtor Party’s possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon the non‑debtor Party’s written request therefor, unless the debtor Party continues to perform all of its obligations under this Agreement or (b) if not delivered under clause (a) above, following the rejection of this Agreement by or on behalf of the debtor Party upon written request therefor by the non‑debtor Party. Whenever a debtor Party or any of its successors or assigns provides to the non-debtor Party any of the intellectual property licensed hereunder (or any embodiment thereof) pursuant to this Section 15.1, the non-debtor Party shall have the right to perform the debtor Party’s obligations hereunder with respect to such intellectual property, but neither such provision nor such performance by such non-debtor Party shall release the debtor Party from liability resulting from rejection of the license or the failure to perform such obligations. Each Party acknowledges and agrees that the payments under Sections 7.4, 7.5 and 7.6 constitute royalties within the meaning of Section 365(n) of the U.S. Bankruptcy Code.

15.2         Governing Law. This Agreement and any disputes, claims, or actions related thereto shall be governed by and construed in accordance with the laws of the State of New York, USA, without regard to any conflicts of law provisions thereof that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction.

15.3         Entire Agreement; Amendment. This Agreement, including the Exhibits hereto, together with the Investment Agreements, is both a final expression of the Parties’ agreement and a complete and exclusive statement with respect to all of its terms. This Agreement supersedes all prior and contemporaneous agreements and communications, whether oral, written or otherwise, concerning any and all matters contained herein, other than the Investment Agreements. The Parties agree that the MNDA is hereby terminated, but each Party’s information that was the subject of confidentiality obligations under the MNDA shall been deemed to be Confidential Information of such Party under this Agreement. This Agreement may only be amended, modified or supplemented in a writing expressly stated for such purpose and signed by an authorized representative of each Party.

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15.4         Relationship Between the Parties. The Parties’ relationship, as established by this Agreement, is solely that of independent contractors. This Agreement does not create any partnership, joint venture, employment, agency or similar business relationship between the Parties. Neither Party is a legal representative of the other Party, and neither Party can assume or create any obligation, representation, warranty or guarantee, express or implied, on behalf of the other Party for any purpose whatsoever. Neither Party (including any successor, assignee, transferee, or Affiliate of a Party) shall treat or report the relationship between the Parties arising under this Agreement as a partnership for U.S. tax purposes without the prior written consent of the other Party, unless required by Applicable Law.

15.5         Non-Waiver. The failure of a Party to insist upon strict performance of any provision of this Agreement or to exercise any right arising out of this Agreement shall neither impair that provision or right nor constitute a waiver of that provision or right, in whole or in part, in that instance or in any other instance. Any waiver by a Party of a particular provision or right shall be in writing, shall be as to a particular matter and, if applicable, for a particular period of time and shall be signed by an authorized representative of such Party.

15.6         Assignment. Except as expressly provided hereunder, neither this Agreement nor any rights or obligations hereunder may be assigned or otherwise transferred by either Party without the prior written consent of the other Party (which consent shall not be unreasonably withheld, conditioned or delayed); provided, however, that either Party may assign this Agreement and its rights and obligations hereunder without the other Party’s consent:

(a)         in connection with the transfer or sale of all or substantially all of such Party’s business related to the Compounds and Products to a Third Party, whether by merger, consolidation, sale of stock, sale of assets, operation of law or otherwise, subject, in the case of Vaxart, to Section 15.7; and

(b)         to an Affiliate of such Party, provided that the assigning Party shall remain liable and responsible to the non‑assigning Party hereto for the performance and observance of all such duties and obligations by such Affiliate.

The rights and obligations of the Parties under this Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties, and the name of a Party appearing herein shall be deemed to include the name of such Party’s successors and permitted assigns to the extent necessary to carry out the intent of this Section 15.6. Any assignment not in accordance with this Agreement shall be void.

15.7         [***].

(a)         [***].

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(b)         [***].

(c)         [***].

(d)         [***].

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15.8         No Third Party Beneficiaries. This Agreement is neither expressly nor impliedly made for the benefit of any party other than those executing it.

15.9         Severability. If, for any reason, any part of this Agreement is adjudicated invalid, unenforceable or illegal by a court of competent jurisdiction, such adjudication shall not affect or impair, in whole or in part, the validity, enforceability or legality of any remaining portions of this Agreement. All remaining portions shall remain in full force and effect as if this original Agreement had been executed without the invalidated, unenforceable or illegal part.

15.10         Notices. Any notice to be given under this Agreement must be in writing and delivered either in person, by any method of mail (postage prepaid) requiring return receipt, or by overnight courier, to the Party to be notified at its address(es) given below, or at any address such Party has previously designated by prior written notice to the other. Notice shall be deemed sufficiently given for all purposes upon the earlier of: (a) the date of actual receipt; or (b) if delivered by overnight courier, the next Business Day the overnight courier regularly makes deliveries.

If to Dynavax: Dynavax Technologies Corporation<br><br> <br>2100 Powell Street, Suite 720<br><br> <br>Emeryville, CA 94608<br><br> <br>Attention: President<br><br> <br>Email: [***]
With a copy (which shall not constitute notice) to: Dynavax Technologies Corporation<br><br> <br>2100 Powell Street, Suite 720<br><br> <br>Emeryville, CA 94608<br><br> <br>Attention: General Counsel<br><br> <br>Email: legal@dynavax.com
If to Vaxart: Vaxart, Inc.<br><br> <br>170 Harbor Way, Suite 300<br><br> <br>South San Francisco, CA 94080<br><br> <br>Attention: [***], Chief Executive Officer;<br><br> <br>[***], General Counsel<br><br> <br>Email: [***]

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With a copy (which shall not constitute notice) to: Thompson Hine, LLP<br><br> <br>300 Madison Ave., 27^th^ Floor<br><br> <br>New York, NY 10017-6232<br><br> <br>Attention: [***]<br><br> <br>Email: [***]

15.11         Force Majeure. Each Party shall be excused from liability for the failure or delay in performance of any obligation under this Agreement if such failure is caused by reason of any event beyond such Party’s reasonable control including but not limited to acts of nature, fire, flood, explosion, earthquake, or other natural forces, war, civil unrest, acts of terrorism, accident, destruction or other casualty, any lack or failure of transportation facilities, any lack or failure of supply of raw materials, or any other event similar to those enumerated above. Such excuse from liability shall be effective only to the extent and duration of the event(s) causing the failure or delay in performance and provided that the Party has not caused such event(s) to occur. Notice of a Party’s failure or delay in performance due to force majeure must be given to the other Party within [***] after its occurrence. All delivery dates under this Agreement that have been affected by force majeure shall be tolled for the duration of such force majeure.

15.12         Further Assurances. Each Party will execute, acknowledge and deliver such further instruments, and do all such other ministerial, administrative or similar acts, as may be reasonably necessary or appropriate in order to carry out the expressly stated purposes and the clear intent of this Agreement. Without limiting the generality of the foregoing, the Parties shall cooperate in good faith to obtain such acknowledgments, confirmations, authorizations, approvals, or consents from governmental agencies as may be reasonably necessary or appropriate to carry out such purposes and intent.

15.13         Interpretation. The headings of clauses contained in this Agreement preceding the text of the sections, subsections, paragraphs and exhibits hereof are inserted solely for convenience and ease of reference only and shall not constitute any part of this Agreement, or have any effect on its interpretation or construction. All references in this Agreement to the singular shall include the plural where applicable. The word “including” (and variations thereof) as used in this Agreement shall mean including, without limiting the generality of any description preceding such term, and the word “or” has the inclusive meaning represented by the phrase “and/or.” Unless otherwise specified, references in this Agreement to any Article shall include all Sections, subsections and paragraphs in such Article, references to any Section shall include all subsections and paragraphs in such Section, and references in this Agreement to any subsection shall include all paragraphs in such subsection. All references in this Agreement to any agreement, instrument or other document will be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified. All references in this Agreement to any specific law, rule or regulation, or article, section or other division thereof, will be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof. All references to days in this Agreement shall mean calendar days, unless otherwise specified. Ambiguities and uncertainties in this Agreement, if any, shall not be interpreted against either Party, irrespective of which Party may be deemed to have caused the ambiguity or uncertainty to exist. This Agreement has been prepared in the English language and the English language shall control its interpretation. In addition, all notices required or permitted to be given hereunder, and all written, electronic, oral or other communications between the Parties regarding this Agreement shall be in the English language.

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15.14         Counterparts; Electronic Delivery. This Agreement may be executed in counterparts with the same effect as if both Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument. Signatures to this Agreement transmitted by facsimile, by email in “portable document format” (“.pdf”), or by any other electronic means intended to preserve the original graphic and pictorial appearance of this Agreement shall have the same effect as physical delivery of the paper document bearing original signature.

[Remainder of this page intentionally left blank.]

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In Witness Whereof, the Parties hereto have duly executed this Exclusive License and Collaboration Agreement as of the Effective Date.

Vaxart, Inc. Dynavax Technologies Corporation
By: /s/ [***]<br><br> <br><br><br> <br>Name: [***]<br><br> <br><br><br> <br>Title: [***] By: /s/ [***]<br><br> <br><br><br> <br>Name: [***]<br><br> <br><br><br> <br>Title: [***]

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Exhibit A

Vaxart Patents as of the Effective Date

[***]

A-1


Exhibit B

Vaxart Product-Specific Patents as of the Effective Date

[***]

B-1


Exhibit C

Initial Development Plan

[***]

C-1


Exhibit D

Contents of EOP2 Data Package

[***]

D-1


Exhibit E

Pre-Approved CMOs and CROs

[***]

E-1


Exhibit F

Vaxart Insurance

[***]

F-1

ex_887369.htm

Exhibit 10.2

SECURITIES PURCHASE AGREEMENT

This Securities Purchase Agreement (this “Agreement”) is dated as of November 4, 2025, between Vaxart, Inc., a Delaware corporation (the “Company”), and the purchaser identified on the signature pages hereto (including its successors and assigns, the “Purchaser”)

WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to an effective registration statement under the Securities Act (as defined below), the Company desires to issue and sell to the Purchaser, and the Purchaser desires to purchase from the Company, securities of the Company as more fully described in this Agreement.

NOW, THEREFORE, IN CONSIDERATION of the mutual covenants contained in this Agreement, and for other good and valuable consideration the receipt and adequacy of which are hereby acknowledged, the Company and the Purchaser agree as follows:

ARTICLE I

DEFINITIONS

1.1 Definitions. In addition to the terms defined elsewhere in this Agreement, for all purposes of this Agreement, the following terms have the meanings set forth in this Section 1.1:

“Affiliate” means any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person as such terms are used in and construed under Rule 405 under the Securities Act.

“Applicable Laws” shall have the meaning ascribed to such term in Section 3.1(bb).

“Authorizations” shall have the meaning ascribed to such term in Section 3.1(bb).

“Base Prospectus” means the prospectus included in the Registration Statement at the time it became effective, including documents incorporated therein by reference.

“BHCA” shall have the meaning ascribed to such term in Section 3.1(z).

“Board of Directors” means the board of directors, or any authorized committee thereof, of the Company.

“Business Day” means any day except any Saturday, any Sunday, any day which is a federal legal holiday in the United States or any day on which banking institutions in the State of New York are authorized or required by law to remain closed.

“Closing” means the closing of the purchase and sale of the Securities pursuant to Section 2.1.

“Closing Date” means the Trading Day on which all of the Transaction Documents have been executed and delivered by the applicable parties thereto, and all conditions precedent to (i) the Purchaser’s obligations to pay the Subscription Amount and (ii) the Company’s obligations to deliver the Securities, in each case, have been satisfied or waived.

“Code” means the United States Internal Revenue Code of 1986, as amended.

“Commission” means the United States Securities and Exchange Commission.

“Common Stock” means the common stock of the Company, par value $0.0001 per share, and any other class of securities into which such securities may hereafter be reclassified or changed.


“Common Stock Equivalents” means any securities of the Company or the Subsidiaries which would entitle the holder thereof to acquire at any time Common Stock, including, without limitation, any debt, preferred stock, right, option, warrant or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock.

“Company Counsel” means Thompson Hine LLP, with offices located at 300 Madison Avenue, 27th Floor, New York, New York 10017-6232.

“Disclosure Time” means, (i) if this Agreement is signed on a day that is not a Trading Day or after 9:25 a.m. (New York City time) and before midnight (New York City time) on any Trading Day, 9:26 a.m. (New York City time) on the Trading Day immediately following the date hereof, and (ii) if this Agreement is signed between midnight (New York City time) and 9:25 a.m. (New York City time) on any Trading Day, no later than 9:26 a.m. (New York City time) on the date hereof.

“Environmental Law” shall have the meaning ascribed to such term in Section 3.1(j).

“Evaluation Date” shall have the meaning ascribed to such term in Section 3.1(s).

“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

“FCPA” means the Foreign Corrupt Practices Act of 1977, as amended, and the rules and regulations thereunder.

“Federal Reserve” shall have the meaning ascribed to such term in Section 3.1(z).

“GAAP” shall have the meaning ascribed to such term in Section 3.1(f).

“Intellectual Property Rights” shall have the meaning ascribed to such term in Section 3.1(m).

“Lien” means a lien, charge, mortgage, pledge, security interest, claim, right of first refusal, pre-emptive right, or other encumbrance of any kind whatsoever.

“Material Adverse Effect” shall have the meaning assigned to such term in Section 3.1(b).

“Material Permits” shall have the meaning assigned to such term in Section 3.1(l).

“Money Laundering Laws” shall have the meaning assigned to such term in Section 3.1(aa).

“OFAC” means the Office of Foreign Assets Control of the U.S. Treasury Department.

“Offering” means the offering of the Securities hereunder.

“Person” means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.

“Per Share Purchase Price” equals $0.45, subject to adjustment for reverse and forward stock splits, stock dividends, stock combinations and other transactions of the Common Stock that occur after the date of this Agreement and before the Closing Date.

“Proceeding” means an action, claim, suit, investigation or proceeding (including, without limitation, an informal investigation or partial proceeding, such as a deposition) pending or, to the Company’s knowledge, threatened in writing against or affecting the Company, a Subsidiary or any of their respective properties before or by any court, arbitrator, governmental or administrative agency or regulatory authority (federal, state, county, local or foreign).

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“Prospectus” means the Prospectus Supplement together with the Base Prospectus, including all documents incorporated therein by reference.

“Prospectus Supplement” means the supplement to the Base Prospectus complying with Rule 424(b) of the Securities Act that is filed with the Commission and delivered by the Company to the Purchaser at the Closing.

“Registration Statement” means the Registration Statement on Form S-3 (File No. 333-270671), filed by the Company with the Commission and declared effective on May 5, 2023, including the information incorporated by reference therein.

“Required Approvals” shall have the meaning ascribed to such term in Section 3.1(e).

“Sanctioned Person” means at any time any person or entity with whom dealings are prohibited under any Sanctions, including as a result of being: (a) listed on any Sanctions-related list of designated or blocked or restricted persons; (b) that is a national of, the government of, or any agency or instrumentality of the government of, or resident in, or organized under the laws of, a country or territory that is the target of comprehensive Sanctions from time to time (as of the date of this Agreement, Cuba, Iran, North Korea, Syria (prior to July 1, 2025), and the Crimea region); or (c) a relationship of ownership, control, or agency with any of the foregoing.

“SEC Reports” shall have the meaning ascribed to such term in Section 3.1(e).

“Securities” means the Shares.

“Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

“Shares” means the shares of Common Stock issued or issuable to the Purchaser pursuant to this Agreement.

“Shell Bank” shall have the meaning ascribed to such term in Section 3.2(f).

“Subscription Amount” means the aggregate amount to be paid for the Shares purchased hereunder as specified below the Purchaser’s name on Annex A of this Agreement and next to the heading “Subscription Amount*,*” in United States dollars and in immediately available funds.

“Subsidiary” and “Subsidiaries” shall have the meanings ascribed to such terms in Section 3.1(a).

“Trading Day” means a day on which trading occurs on the Trading Market or, if trading does not occur on the Trading Market, any Business Day.

“Trading Market” means OTCQX® Best Market, operated by the OTC Markets Group, Inc.; provided, however, that in the event the Company’s Common Stock is ever listed or traded on The Nasdaq Capital Market, The Nasdaq Global Market, The Nasdaq Global Select Market, the New York Stock Exchange, the NYSE Arca, or the NYSE American (or any nationally recognized successor to any of the foregoing), then the “Trading Market” shall mean such other market or exchange on which the Company’s Common Stock is then listed or traded.

“Transaction Documents” means this Agreement, all exhibits and schedules hereto and any other documents or agreements executed in connection with the transactions contemplated hereunder.

“Transfer Agent” means Equiniti Trust Company, LLC, the current transfer agent of the Company and any successor transfer agent of the Company.

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ARTICLE II

PURCHASE AND SALE

2.1 Closing. On the Closing Date, upon the terms and subject to the conditions set forth herein, the Company agrees to sell, and the Purchaser agrees to purchase, 11,111,111 Shares for an aggregate consideration of $4,999,999.95. The Purchaser’s Subscription Amount shall be made available for Delivery Versus Payment (“DVP”) settlement with the Company or its designees. Upon satisfaction of the covenants and conditions set forth in Sections 2.2 and 2.3, the Closing shall take place remotely by electronic transfer of the Closing documentation. Upon receipt of the Subscription Amount, the Company shall issue the Shares registered in the Purchaser’s name and address and released by the Transfer Agent directly to the account identified by the Purchaser.

2.2 Deliveries

(a)          On or prior to the Closing Date, the Company shall deliver or cause to be delivered to the Purchaser the following:

(i)          this Agreement duly executed by the Company;

(ii)          a legal opinion of Company Counsel, directed to the Purchaser, in form and substance reasonably acceptable to the Purchaser;

(iii)          a copy of the irrevocable instructions to the Transfer Agent instructing the Transfer Agent to deliver on an expedited basis via DTC’s Deposit and Withdrawal at Custodian system the Shares registered in the Purchaser’s name;

(iv)          the Company’s wire instructions, on Company letterhead and executed by the Chief Executive Officer or Chief Financial Officer of the Company;

(v)         a certificate of the Company, dated as of the Closing Date, signed by the Chief Executive Officer and Chief Financial Officer of the Company, substantially in the form attached hereto as Exhibit A-1;

(vi)         a certificate of the Company’s secretary in substantially the form attached hereto as Exhibit A-2, certifying (i) that the Company’s certificate of incorporation and bylaws are true and complete, and have not been modified and are in full force and effect, (ii) that the resolutions of the Board of Directors relating to the Offering are in full force and effect and have not been modified, and (iii) as to the incumbency of the officers of the Company; and

(vii)         the Prospectus and Prospectus Supplement.

(b)          On or prior to the Closing Date, the Purchaser shall deliver or cause to be delivered to the Company the following:

(i)          this Agreement duly executed by the Purchaser; and

(ii)         the Subscription Amount by wire transfer to the account specified in writing by the Company.

2.3 Closing Conditions

(a) The obligations of the Company hereunder in connection with the Closing are subject to the following conditions being met:

(i)         the accuracy in all material respects (or, to the extent representations or warranties are qualified by materiality or Material Adverse Effect, in all respects) when made and on the Closing Date of the representations and warranties of the Purchaser contained herein (unless as of a specific date therein in which case they shall be accurate as of such date);

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(ii)         all obligations, covenants and agreements of the Purchaser required to be performed at or prior to the Closing Date shall have been performed; and

(iii)         the delivery by the Purchaser of the items set forth in Section 2.2(b) of this Agreement.

(b) The respective obligations of the Purchaser hereunder in connection with the Closing are subject to the following conditions being met:

(i)         the accuracy in all material respects (or, to the extent representations or warranties are qualified by materiality or Material Adverse Effect, in all respects) when made and on the Closing Date of the representations and warranties of the Company contained herein (unless as of a specific date therein in which case they shall be accurate as of such date); and

(ii)         all obligations, covenants and agreements of the Company required to be performed at or prior to the Closing Date shall have been performed.

(iii)         the delivery by the Company of the items set forth in Section 2.2(a) of this Agreement;

(iv)         there shall have been no Material Adverse Effect with respect to the Company; and

(v)         from the date hereof to the Closing Date, trading in the Common Stock shall not have been suspended by the Commission or the Company’s principal Trading Market, and, at any time prior to the Closing Date, trading in securities generally as reported by Bloomberg L.P. shall not have been suspended or limited, or minimum prices shall not have been established on securities whose trades are reported by such service, or on any Trading Market, nor shall a banking moratorium have been declared either by the United States or New York State authorities nor shall there have occurred any material outbreak or escalation of hostilities or other national or international calamity of such magnitude in its effect on, or any material adverse change in, any U.S. financial market which, in each case, in the reasonable judgment of such Purchaser, makes it impracticable or inadvisable to purchase the Securities at the Closing.

ARTICLE III

REPRESENTATIONS AND WARRANTIES

3.1 Representations and Warranties of the Company. Except as set forth in the SEC Reports, which SEC Reports shall qualify any representation or warranty made herein, the Company hereby makes the following representations and warranties to the Purchaser:

(a) Subsidiaries. All of the direct and indirect subsidiaries of the Company are set forth in the SEC Reports (each, a “Subsidiary”, and collectively, the “Subsidiaries”). The Company owns, directly or indirectly, all of the capital stock or other equity interests of each Subsidiary free and clear of any Liens, and all of the issued and outstanding shares of capital stock or equity interests, as applicable, of each Subsidiary are validly issued and are fully paid, non-assessable and free of preemptive and similar rights to subscribe for or purchase securities.

(b) Organization and Qualification. Each of the Company and the Subsidiaries is an entity duly incorporated or otherwise organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation or organization, with the requisite power and authority to own and use its properties and assets and to carry on its business as currently conducted. Neither the Company nor any Subsidiary is in violation nor default of any of the provisions of its respective articles of association, certificate or articles of incorporation, bylaws or other organizational or charter documents. Each of the Company and the Subsidiaries is duly qualified to conduct business and is in good standing as a foreign corporation or other entity in each jurisdiction in which the nature of the business conducted or property owned by it makes such qualification necessary, except where the failure to be so qualified or in good standing, as the case may be, would not have or reasonably be expected to result in (i) a material adverse effect on the legality, validity or enforceability of any Transaction Document, (ii) a material adverse effect on the results of operations, properties, assets, management, stockholders’ equity, business or condition (financial or otherwise) of the Company and the Subsidiaries, taken as a whole, or (iii) a material adverse effect on the Company’s ability to perform in any material respect on a timely basis its obligations under any Transaction Document (any of (i), (ii) or (iii), “Material Adverse Effect”). No proceeding has been instituted in any jurisdiction revoking, limiting or curtailing or seeking to revoke, limit or curtail such power and authority or qualification.

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(c) Authorization; Enforcement. The Company has the requisite corporate power and authority to enter into and to consummate the transactions contemplated by this Agreement and each of the other Transaction Documents and otherwise to carry out its obligations hereunder and thereunder. The execution and delivery of this Agreement and each of the other Transaction Documents by the Company and the consummation by it of the transactions contemplated hereby and thereby have been duly authorized by all necessary action on the part of the Company and no further action is required by the Company, the Board of Directors or the Company’s stockholders or others in connection herewith or therewith other than in connection with the Required Approvals.

(d) No Conflicts. The execution, delivery and performance by the Company of this Agreement, the issuance and sale of the Securities and the consummation by it of the transactions contemplated hereby do not and will not (i) conflict with or violate any provision of the Company’s or any Subsidiary’s certificate or articles of incorporation, bylaws or other organizational or charter documents, or (ii) conflict with, or constitute a default (or an event that with notice or lapse of time or both would become a default) under, result in the creation of any Lien upon any of the properties or assets of the Company or any Subsidiary, or give to others any rights of termination, amendment, anti-dilution or similar adjustments, acceleration or cancellation (with or without notice, lapse of time or both) of, any agreement, credit facility, debt or other instrument (evidencing a Company or Subsidiary debt or otherwise) or other understanding to which the Company or any Subsidiary is a party or by which any property or asset of the Company or any Subsidiary is bound or affected and is required to be filed as an exhibit to the SEC Reports, or (iii) subject to the Required Approvals, conflict with or result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction of any court or governmental authority, to which the Company or a Subsidiary is subject (including federal and state securities laws and regulations), or by which any property or asset of the Company or a Subsidiary is bound or affected; except in the case of each of clauses (ii) and (iii), such as would not have a Material Adverse Effect.

(e) Filings, Consents and Approvals. The Company is not required to obtain any consent, waiver, authorization or order of, give any notice to, or make any filing or registration with, any court or other federal, state (including state blue sky law), local or other governmental authority or other Person in connection with the execution, delivery and performance by the Company of this Agreement, other than: (i) the filings required pursuant to Section 4.4 of this Agreement, (ii) such filings as are required to be made under applicable state securities laws, and (iii) the filing with the Commission of the Prospectus Supplement (collectively, the “Required Approvals”).

(f) Issuance of the Securities. The Shares are duly authorized and, when issued and paid for in accordance with this Agreement, will be validly issued, fully paid and nonassessable, free and clear of all Liens. The Company has reserved from its duly authorized capital stock the maximum number of shares of Common Stock issuable pursuant to this Agreement. The Company has prepared and filed the Registration Statement in conformity with the requirements of the Securities Act, which became effective on May 5, 2023, including the Base Prospectus, and such amendments and supplements thereto as may have been required to the date of this Agreement. The Registration Statement is effective under the Securities Act. No stop order preventing or suspending the effectiveness of the Registration Statement or the use of the Prospectus Supplement has been issued by the Commission, and no proceedings for that purpose have been instituted or, to the knowledge of the Company, are threatened by the Commission. At the time the Registration Statement and any amendments thereto became effective, and on the date hereof and the Closing Date, the Registration Statement and any amendments thereto conformed and will conform in all material respects to the requirements of the Securities Act and did not and will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein not misleading. The Prospectus and any amendments or supplements thereto, at the time the Prospectus or any amendment or supplement thereto was issued and on the Closing Date, conformed and will conform in all material respects to the requirements of the Securities Act and did not and will not contain an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The Securities conform in all material respects to all statements with respect thereto contained in the Registration Statement and the Prospectus. The Company was at the time of filing of the Registration Statement eligible to use Form S-3. The Company meets the requirements for use of Form S-3 under the Securities Act.

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(g) Capitalization. The equity capitalization of the Company is as set forth in the SEC Reports as of the dates indicated therein. As of the date hereof, the Company has authorized 350,000,000 shares of its Common Stock, 228,958,733 shares of which are issued and outstanding. The Company has not issued any capital stock since its most recently filed SEC Report, other than pursuant to the exercise of stock options under the Company’s stock option plans. Except as set forth in the SEC Reports, the Company has no outstanding options, warrants, scrips or rights to subscribe to, calls or commitments of any character whatsoever relating to, or securities, rights or obligations convertible into or exercisable or exchangeable for, or giving any Person any right to subscribe for or acquire, any Common Stock, or contracts, commitments, understandings or arrangements by which the Company is or may become bound to issue additional Common Stock or Common Stock Equivalents, and no Person has any right of first refusal, pre-emptive right, right of participation, or any similar right to participate in the transactions contemplated hereby. Except as set forth in the SEC Reports, the issuance and sale of the Securities will not obligate the Company to issue Common Stock or other securities to any Person (other than the Purchaser). There are no outstanding securities or instruments of the Company with any provision that adjusts the exercise, conversion, exchange or reset price of such security or instrument upon an issuance of securities by the Company. There are no outstanding securities or instruments of the Company that contain any redemption or similar provisions, and there are no contracts, commitments, understandings or arrangements by which the Company is or may become bound to redeem an equity security of the Company. The Company does not have any stock appreciation rights or “phantom share” plans or agreements or any similar plan or agreement. Except as set forth in the SEC Reports, there are no stockholders agreements, voting agreements or other similar agreements with respect to the Company’s capital stock to which the Company is a party or, to the knowledge of the Company, between or among any of the Company’s stockholders.

(e) SEC Reports. The Company has filed all reports, schedules, forms, statements and other documents required to be filed by the Company under the Exchange Act, including pursuant to Section 13(a) or 15(d) thereof, for the twelve (12) month period through the date hereof (or such shorter period as the Company was required by law or regulation to file such material) (the foregoing materials, including the exhibits thereto and documents incorporated by reference therein, being collectively referred to herein as the “SEC Reports”) on a timely basis or has received a valid extension (or waiver from the Commission) of such time of filing and has filed any such SEC Reports prior to the expiration of any such extension. As of their respective dates, the SEC Reports complied in all material respects with the requirements of the Securities Act and the Exchange Act, as applicable, and none of the SEC Reports, when filed, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading.

(f) Financial Statements. The financial statements of the Company included in the SEC Reports comply in all material respects with applicable accounting requirements and the rules and regulations of the Commission with respect thereto as in effect at the time of filing. Such financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”), except as may be otherwise specified in such financial statements or the notes thereto and except that unaudited financial statements may not contain all footnotes required by GAAP, and fairly present in all material respects the financial position of the Company and its consolidated Subsidiaries as of and for the dates thereof and the results of operations and cash flows for the periods then ended, subject, in the case of unaudited statements, to normal, immaterial, year-end audit adjustments. Since the date of the latest audited financial statements included within the SEC Reports, (i) there has been no event, occurrence or development that has had or that would reasonably be expected to result in a Material Adverse Effect, (ii) the Company has not incurred any liabilities (contingent or otherwise) other than (A) trade payables and accrued expenses incurred in the ordinary course of business consistent with past practice and (B) liabilities not required to be reflected in the Company’s financial statements pursuant to GAAP or disclosed in filings made with the Commission, (iii) the Company has not altered its method of accounting, (iv) the Company has not declared or made any dividend or distribution of cash or other property to its stockholders or purchased, redeemed or made any agreements to purchase or redeem any shares of its capital stock and (v) the Company has not issued any equity securities to any officer, director or Affiliate, except pursuant to existing Company stock option plans.

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(g) Litigation. Except as set forth in the SEC Reports, there is no action, suit, inquiry, notice of violation, Proceeding or investigation pending or, to the knowledge of the Company, threatened against or affecting the Company, any Subsidiary or any of their respective properties before or by any court, arbitrator, governmental or administrative agency or regulatory authority (federal, state, county, local or foreign) (collectively, an “Action”) which (i) adversely affects or challenges the legality, validity or enforceability of any of the Transaction Documents or the Securities or (ii) would, if there were an unfavorable decision, have or reasonably be expected to result in a Material Adverse Effect. Neither the Company nor any Subsidiary, nor any director or executive officer thereof, is or has been the subject of any Action involving a claim of violation of or liability under federal or state securities laws or a claim of breach of fiduciary duty, which could result in a Material Adverse Effect. There has not been, and to the knowledge of the Company, there is not pending or contemplated, any investigation by the Commission involving the Company or any current or former director or executive officer of the Company. The Commission has not issued any stop order or other order suspending the effectiveness of any registration statement filed by the Company or any Subsidiary under the Exchange Act or the Securities Act.

(h) Labor Relations. The Company and its Subsidiaries have complied with all U.S. federal, state, local and foreign laws and regulations relating to employment and employment practices, terms and conditions of employment and wages and hours, except where the failure to comply would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

(i) Compliance. Neither the Company nor any Subsidiary: (i) is in default under or in violation of (and no event has occurred that has not been waived that, with notice or lapse of time or both, would result in a default by the Company or any Subsidiary under), nor has the Company or any Subsidiary received notice of a claim that it is in default under or that it is in violation of, any indenture, loan or credit agreement or any other agreement or instrument to which it is a party or by which it or any of its properties is bound (whether or not such default or violation has been waived), (ii) is in violation of any judgment, decree or order of any court, arbitrator or other governmental authority or (iii) is or has been in violation of any statute, rule, ordinance or regulation of any governmental authority, including without limitation all foreign, federal, state and local laws relating to taxes, environmental protection, occupational health and safety, product quality and safety and employment and labor matters, except in each case as would not have or reasonably be expected to result in a Material Adverse Effect.

(j) Environmental Law. There has been no storage, generation, transportation, handling, use, treatment, disposal, discharge, emission, contamination, release or other activity involving any kind of hazardous, toxic or other wastes, pollutants, contaminants, petroleum products or other hazardous or toxic substances, chemicals or materials by, due to, on behalf of, or caused by the Company or any Subsidiary (or, to the Company’s knowledge, any other entity for whose acts or omissions the Company is or may be liable) upon any property now or previously owned, operated, used or leased by the Company or any Subsidiary, or upon any other property, which would be a violation of or give rise to any liability under any applicable law, rule, regulation, order, judgment, decree or permit, common law provision or other legally binding standard relating to pollution or protection of human health and the environment (“Environmental Law”), except for violations and liabilities which, individually or in the aggregate, would not have a Material Adverse Effect. The Company and each Subsidiary has all permits, authorizations and approvals required under any applicable Environmental Laws and are each in compliance with their requirements.

(k) Title to Assets. The Company and the Subsidiaries have good and marketable title in fee simple to all real property owned by them and good and marketable title in all personal property owned by them that is material to the business of the Company and the Subsidiaries, in each case free and clear of all Liens, except for (i) Liens as do not materially affect the value of such property and do not materially interfere with the use made and proposed to be made of such property by the Company and the Subsidiaries and (ii) Liens for the payment of federal, state or other taxes, for which adequate accruals or reserves have been made therefor in accordance with GAAP and the payment of which is neither delinquent nor subject to penalties. Any real property and facilities currently held under lease by the Company and the Subsidiaries are held by them under valid, subsisting and enforceable leases with which the Company and the Subsidiaries are in compliance in all material respects, except where the failure to so comply would not reasonably be expected to have a Material Adverse Effect.

(l) Regulatory Permits. The Company and the Subsidiaries possess all material certificates, authorizations and permits issued by the appropriate federal, state, local or foreign regulatory authorities necessary to conduct their respective businesses as described in the SEC Reports, except where the failure to possess such permits could not reasonably be expected to result in a Material Adverse Effect (“Material Permits”), and neither the Company nor any Subsidiary has received any notice of proceedings relating to the revocation or modification of any Material Permit.

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(m) Intellectual Property. Except as set forth in the SEC Reports, to the Company’s knowledge, the Company and the Subsidiaries have, or have rights to use (or can acquire on reasonable terms), all patents, patent applications, trademarks, trademark applications, service marks, trade names, trade secrets, inventions, copyrights, licenses and other intellectual property rights and similar rights necessary or required for use in connection with their respective businesses as described in the SEC Reports and which the failure to so have could have a Material Adverse Effect (collectively, the “Intellectual Property Rights”). To the knowledge of the Company, all such Intellectual Property Rights are enforceable, and there is no existing infringement by another Person of any of the Intellectual Property Rights. The Company and its Subsidiaries have taken reasonable security measures to protect the secrecy, confidentiality and value of all of their intellectual properties, except where failure to do so would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

(n) Insurance. The Company and the Subsidiaries are insured by insurers of recognized financial responsibility against such losses and risks and in such amounts as are prudent and customary in the businesses in which the Company and the Subsidiaries are engaged, including, but not limited to, directors and officers insurance coverage at least equal to the aggregate Subscription Amount. Neither the Company nor any Subsidiary has any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business without a significant increase in cost.

(n) Transactions With Affiliates and Employees. Except as set forth in the SEC Reports, none of the executive officers or directors of the Company or any Subsidiary and, to the knowledge of the Company, none of the employees of the Company or any Subsidiary is presently a party to any transaction with the Company or any Subsidiary (other than for services as employees, executive officers and directors), including any contract, agreement or other arrangement providing for the furnishing of services to or by, providing for rental of real or personal property to or from, providing for the borrowing of money from or lending of money to or otherwise requiring payments to or from any executive officer, director or such employee or, to the knowledge of the Company, any entity in which any executive officer, director, or any such employee has a substantial interest or is an officer, director, trustee, stockholder, member or partner, in each case in excess of $120,000 other than for (i) payment of salary or consulting fees for services rendered, (ii) reimbursement for expenses incurred on behalf of the Company and (iii) other employee benefits, including stock option agreements under any stock option plan of the Company.

(o) Sarbanes-Oxley; Internal Accounting Controls. The Company and the Subsidiaries are in compliance with all applicable provisions of the Sarbanes-Oxley Act of 2002, as amended, except as disclosed in the Company’s SEC Reports. The Company and the Subsidiaries maintain a system of internal accounting controls sufficient to provide reasonable assurance that: (i) transactions are executed in accordance with management’s general or specific authorizations, (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with applicable securities laws and GAAP and to maintain asset accountability, (iii) access to assets is permitted only in accordance with management’s general or specific authorization, and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. The Company and the Subsidiaries have established disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the Company and the Subsidiaries and designed such disclosure controls and procedures to ensure that information required to be disclosed by the Company in the reports it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Commission’s rules and forms. The Company’s certifying officers have evaluated the effectiveness of the disclosure controls and procedures of the Company and the Subsidiaries as of applicable dates specified under the Exchange Act (such date, the “Evaluation Date”). The Company presented in its most recently filed periodic report under the Exchange Act the conclusions of the certifying officers about the effectiveness of the disclosure controls and procedures based on their evaluations as of the Evaluation Date. Except as set forth in SEC Reports, since the Evaluation Date, there have been no changes in the internal control over financial reporting (as such term is defined in the Exchange Act) of the Company and the Subsidiaries that have materially affected, or is reasonably likely to materially affect, the internal control over financial reporting of the Company and the Subsidiaries.

(p) Investment Company. The Company is not, and immediately after receipt of payment for the Securities, will not be required to register as an “investment company” within the meaning of the Investment Company Act of 1940, as amended. The Company shall conduct its business in a manner so that it will not be required to register as an “investment company” subject to registration under the Investment Company Act of 1940, as amended.

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(q) Registration Rights. Except as set forth in the SEC Reports, no Person has any right to cause the Company or any Subsidiary to effect the registration under the Securities Act of any securities of the Company or any Subsidiary.

(r) Listing and Maintenance Requirements. The Common Stock is registered pursuant to Section 12(b) or 12(g) of the Exchange Act, and the Company has taken no action designed to, or which to its knowledge is likely to have the effect of, terminating the registration of the Common Stock under the Exchange Act nor has the Company received any notification that the Commission is contemplating terminating such registration. The Common Stock is currently eligible for electronic transfer through the Depository Trust Company or another established clearing corporation, and the Company is current in payment of the fees to the Depository Trust Company (or such other established clearing corporation) in connection with such electronic transfer.

(s) Solvency. The Company hereby represents and warrants to Purchaser, as of the Closing Date, that after giving effect to the transactions contemplated herein, (i) the fair value of the assets of the Company is greater than the total amount of liabilities, including contingent liabilities, of the Company, (ii) the Company has not incurred, and does not currently intend to incur or contemplate incurring, debts or liabilities beyond its ability to pay its own debts and liabilities as they mature, and (iii) the Company is not engaged in a business or a transaction, and is not about to engage in a business or a transaction, for which its property would constitute unreasonably small capital.

(t) Tax Status. Except for matters that would not, individually or in the aggregate, have or reasonably be expected to result in a Material Adverse Effect, the Company and its Subsidiaries each (i) has made or filed all United States federal, state and local income and all foreign tax returns, reports and declarations required by any jurisdiction to which it is subject, (ii) has paid all taxes and other governmental assessments and charges that are material in amount, shown or determined to be due on such returns, reports and declarations and (iii) has set aside on its books provision reasonably adequate for the payment of all material taxes for periods subsequent to the periods to which such returns, reports or declarations apply. There are no unpaid taxes in any material amount claimed to be due by the taxing authority of any jurisdiction, and the officers of the Company or of any Subsidiary know of no basis for any such claim.

(u) Foreign Corrupt Practices; Criminal Acts. Neither the Company nor any Subsidiary has (i) directly or indirectly, used any funds for unlawful contributions, gifts, entertainment or other unlawful expenses related to foreign or domestic political activity, (ii) directly or indirectly made, offered, provided, paid, or authorized the provision of, any unlawful payment or anything of value to foreign or domestic government officials or employees, officials or employees of state-owned or controlled entities, or to any foreign or domestic political candidates or parties or campaigns from corporate funds, (iii) failed to disclose fully any contribution made by the Company or any Subsidiary (or made by any person acting on its behalf of which the Company is aware) which is in violation of law, or (iv) violated any provision of the FCPA or other applicable anti-corruption and anti-bribery laws.

(v) Accountants. The Company’s independent registered public accounting firm is as set forth in the SEC Reports. To the knowledge and belief of the Company, such accounting firm is a registered public accounting firm as required by the Exchange Act.

(w) Office of Foreign Assets Control. Neither the Company nor any Subsidiary nor, to the Company's knowledge, any director, officer, agent, employee or Affiliate of the Company or any Subsidiary is currently subject to any “Sanctions,” which shall include but are not limited to any U.S. sanctions administered by the Office of Foreign Assets Control of the U.S. Treasury Department (“OFAC”), and the Company will not, directly or indirectly, use the proceeds of the Offering hereunder, or lend, contribute or otherwise make available such proceeds to any subsidiary, joint venture partner or other person or entity, for the purpose of financing the activities of any person currently subject to any Sanctions, including but not limited to U.S. sanctions administered by OFAC.

(x) Stock Option Plans. Each stock option granted by the Company under the Company’s stock option plan, or as an inducement grant outside of a stock option plan, was granted (i) in accordance with the terms of such plan, or under its terms, respectively, and (ii) with an exercise price at least equal to the fair market value of the Common Stock on the date such stock option would be considered granted under GAAP and applicable law. No stock option granted under the Company’s stock option plan or omnibus long-term incentive plan has been backdated. The Company has not knowingly granted, and there is no and has been no Company policy or practice to knowingly grant, stock options prior to, or otherwise knowingly coordinate the grant of stock options with, the release or other public announcement of material information regarding the Company or the Subsidiaries or their financial results or prospects.

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(y) U.S. Real Property Holding Corporation. The Company is not and has never been a United States real property holding corporation within the meaning of Section 897 of the Code, and the Company shall so certify upon Purchaser’s request.

(z) Bank Holding Company Act. Neither the Company nor any of its Subsidiaries or Affiliates is subject to the Bank Holding Company Act of 1956, as amended (the “BHCA”) and to regulation by the Board of Governors of the Federal Reserve System (the “Federal Reserve”). Neither the Company nor any of its Subsidiaries owns or controls, directly or indirectly, five percent (5%) or more of the outstanding shares of any class of voting securities or twenty-five percent (25%) or more of the total equity of a bank or any entity that is subject to the BHCA and to regulation by the Federal Reserve. Neither the Company nor any of its Subsidiaries exercises a controlling influence over the management or policies of a bank or any entity that is subject to the BHCA and to regulation by the Federal Reserve.

(aa) Money Laundering. The operations of the Company and its Subsidiaries are and have been conducted at all times in compliance with applicable financial record-keeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, applicable money laundering statutes and applicable rules and regulations thereunder (collectively, the “Money Laundering Laws”), and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company or any Subsidiary with respect to the Money Laundering Laws is pending or, to the knowledge of the Company or any Subsidiary, threatened.

(bb) Regulatory. Except as described in the SEC Reports, the Company and its Subsidiaries (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company including, without limitation the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, the regulations promulgated pursuant to such laws, and any successor government programs and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices and all other local, state, federal, national, supranational and foreign laws, manual provisions, policies and administrative guidance relating to the regulation of the Company (collectively, the “Applicable Laws”); (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations; (iv) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) have not received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

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(cc) No Integrated Offering. Assuming the accuracy of the Purchaser’s representations and warranties set forth in Section 3.2, neither the Company, nor any of its Affiliates, nor any Person acting on its or their behalf has, directly or indirectly, made any offers or sales of any security or solicited any offers to buy any security, under circumstances that would cause this offering of the Securities to be integrated with prior offerings by the Company for purposes of the Securities Act or any applicable shareholder approval provisions.

(dd) Disclosure. Except with respect to the material terms and conditions of the transactions contemplated by the Transaction Documents, the Company confirms that neither it nor any other Person acting on its behalf has provided any of the Purchasers or their agents or counsel with any information that it believes constitutes or might constitute material, non-public information. The Company understands and confirms that the Purchasers will rely on the foregoing representation in effecting transactions in securities of the Company. All of the disclosure furnished by or on behalf of the Company to the Purchasers regarding the Company and the Subsidiaries, their respective businesses and the transactions contemplated hereby, is true and correct and does not contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading. The Company acknowledges and agrees that no Purchaser makes or has made any representations or warranties with respect to the transactions contemplated hereby other than those specifically set forth in Section 3.2 hereof.

3.2 Representations and Warranties of the Purchaser. The Purchaser hereby represents and warrants, as of the date hereof and as of the Closing Date to the Company as follows (unless as of a specific date therein, in which case they shall be accurate as of such date):

(a) Organization; Authority. The Purchaser is an entity duly incorporated or formed, validly existing and in good standing under the laws of the jurisdiction of its incorporation or formation with full right, corporate, partnership, limited liability company or similar power and authority to enter into and to consummate the transactions contemplated by the Transaction Documents and otherwise to carry out its obligations hereunder and thereunder. The execution and delivery of the Transaction Documents and performance by the Purchaser of the transactions contemplated by the Transaction Documents have been duly authorized by all necessary corporate, partnership, limited liability company or similar action, as applicable, on the part of the Purchaser. Each Transaction Document to which it is a party has been duly executed by the Purchaser, and when delivered by the Purchaser in accordance with the terms hereof or thereof, will constitute the valid and legally binding obligation of the Purchaser, enforceable against it in accordance with its terms, except: (i) as limited by general equitable principles and applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally; (ii) as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies; and (iii) insofar as indemnification and contribution provisions may be limited by applicable law.

(b) Informed Investment Decision. Based on the information the Purchaser has deemed appropriate, it has independently made its own analysis and decision to enter into the Transaction Documents. The Purchaser has sought its own accounting, legal and tax advice as it has considered necessary to make an informed decision with respect to its acquisition of the Securities.

(c) Understandings or Arrangements. The Purchaser is acquiring the Securities as principal for its own account and has no direct or indirect arrangement or understandings with any other persons to distribute or regarding the distribution of such Securities.

(d) Purchaser Status. The Purchaser is a corporation that has a net worth on a consolidated basis according to its most recent audited financial statement of not less than $14,000,000.

(e) Access to Information. Such Purchaser acknowledges that it has had the opportunity to review the Transaction Documents (including all exhibits and schedules thereto) and the SEC Reports and has been afforded, (i) the opportunity to ask such questions as it has deemed necessary of, and to receive answers from, representatives of the Company concerning the terms and conditions of the offering of the Securities and the merits and risks of investing in the Securities; (ii) access to information about the Company and its financial condition, results of operations, business, properties, management and prospects sufficient to enable it to evaluate its investment; (iii) the opportunity to obtain such additional information that the Company possesses or can acquire without unreasonable effort or expense that is necessary to make an informed investment decision with respect to the investment; and (iv) the opportunity to ask questions of management and any such questions have been answered to such Purchaser’s reasonable satisfaction.

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(f) Sanctioned Persons; BSA/PATRIOT Act. **** Purchaser is not 50% or more owned or otherwise controlled by or acting on behalf of (in connection with this Agreement), a Person that is the subject or target of Sanctions. Purchaser is not an institution that accepts currency for deposit and that (a) has no physical presence in the jurisdiction in which it is incorporated or in which it is operating and (b) is unaffiliated with a regulated financial group that is subject to consolidated supervision (a “Shell Bank”) or providing banking services to a Shell Bank. Purchaser represents that if it is a financial institution subject to the Bank Secrecy Act (31 U.S.C. Section 5311 et seq.), as amended by the USA PATRIOT Act of 2001 and its implementing regulations (collectively, the “BSA/PATRIOT Act”), that Purchaser maintains policies and procedures reasonably designed to comply with applicable obligations under the BSA/PATRIOT Act. Purchaser further represents and warrants that (a) the funds held by Purchaser and used to purchase the Securities were not directly or indirectly derived from or related to any activities that may contravene U.S. federal, state or applicable non-U.S. anti-money laundering, anti-corruption or Sanctions and (b) any returns from the Purchaser’s investment will not be used in violation of applicable anti-money laundering, anti-corruption, or Sanctions.

The Company acknowledges and agrees that the representations contained in this Section 3.2 shall not modify, amend or affect the Purchaser’s right to rely on the Company’s representations and warranties contained in this Agreement or any other document or instrument executed and/or delivered in connection with this Agreement or the consummation of the transactions contemplated hereby.

ARTICLE IV

OTHER AGREEMENTS OF THE PARTIES

4.1 Legends. The Shares shall be issued free of all restrictive legends.

4.2 Reservation of Common Stock. As of the Closing Date, the Company has reserved and shall continue to reserve and keep available at all times, free of preemptive rights, a sufficient number of shares of Common Stock for the purpose of enabling the Company to issue the Shares pursuant to this Agreement.

4.2 Furnishing of Information. Until the Purchaser no longer owns Securities, the Company covenants to timely file (or obtain extensions in respect thereof and file within the applicable grace period) all reports required to be filed by the Company after the date hereof pursuant to the Exchange Act even if the Company is not then subject to the reporting requirements of the Exchange Act.

4.3 Integration. The Company shall not sell, offer for sale or solicit offers to buy or otherwise negotiate in respect of any security (as defined in Section 2 of the Securities Act) that would be integrated with the offer or sale of the Securities for purposes of the rules and regulations of any Trading Market such that it would require shareholder approval prior to the closing of such other transaction unless shareholder approval is obtained before the closing of such subsequent transaction.

4.4 Securities Laws Disclosure; Publicity. The Company shall (a) by the Disclosure Time, issue a press release disclosing the material terms of the transactions contemplated hereby, and (b) file a Current Report on Form 8-K, including the Transaction Documents as exhibits thereto, with the Commission within the time required by the Exchange Act. From and after the issuance of such press release, the Company represents to the Purchaser that it shall have publicly disclosed all material, non-public information delivered to any of the Purchaser by the Company or any of its Subsidiaries, or any of their respective officers, directors, employees or agents in connection with the transactions contemplated by the Transaction Documents. In addition, effective upon the issuance of such press release, the Company acknowledges and agrees that any and all confidentiality or similar obligations under any agreement, whether written or oral, between the Company, any of its Subsidiaries or any of their respective officers, directors, agents, employees or Affiliates on the one hand, and any of the Purchaser or any of their Affiliates, on the other hand, shall terminate. The Company and the Purchaser shall consult with each other in issuing any other press releases with respect to the transactions contemplated hereby, and neither the Company nor the Purchaser shall issue any such press release nor otherwise make any such public statement without the prior consent of the Company, with respect to any press release of the Purchaser, or without the prior consent of the Purchaser, with respect to any press release of the Company, which consent shall not unreasonably be withheld or delayed, except if such disclosure is required by law, in which case the disclosing party shall promptly provide the other party with prior notice of such public statement or communication. Notwithstanding the foregoing, the Company shall not publicly disclose the name of the Purchaser, or include the name of the Purchaser in any filing with the Commission or any regulatory agency or Trading Market, without the prior written consent of such Purchaser, except (a) as required by federal securities law in connection with the filing of final Transaction Documents with the Commission and (b) to the extent such disclosure is required by law or Trading Market regulations, in which case the Company shall provide the Purchaser with prior notice of such disclosure permitted under this clause (b).

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4.5 Non-Public Information. Except with respect to the material terms and conditions of the transactions contemplated by the Transaction Documents, which shall be disclosed pursuant to Section 4.3, the Company covenants and agrees that neither it, nor any other Person acting on its behalf will provide the Purchaser or its agents or counsel with any information that constitutes, or the Company reasonably believes constitutes, material non-public information, unless prior thereto such Purchaser shall have consented to the receipt of such information and agreed with the Company to keep such information confidential. The Company understands and confirms that the Purchaser shall be relying on the foregoing covenant in effecting transactions in securities of the Company. To the extent that the Company delivers any material, non-public information to the Purchaser without such Purchaser’s consent, the Company hereby covenants and agrees that such Purchaser shall not have any duty of confidentiality to the Company, any of its Subsidiaries, or any of their respective officers, directors, agents, employees or Affiliates, or a duty to the Company, any of its Subsidiaries or any of their respective officers, directors, agents, employees or Affiliates not to trade on the basis of, such material, non-public information, provided that the Purchaser shall remain subject to applicable law. To the extent that any notice provided pursuant to any Transaction Document constitutes, or contains, material, non-public information regarding the Company or any Subsidiaries, the Company shall simultaneously file such notice with the Commission pursuant to a Current Report on Form 8-K. The Company understands and confirms that the Purchaser shall be relying on the foregoing covenant in effecting transactions in securities of the Company.

4.6 Listing of Common Stock. The Company hereby agrees to use commercially reasonable efforts to maintain the listing or quotation of the Common Stock on the Trading Market on which it is currently listed. The Company further agrees, if the Company applies to have the Common Stock traded on any other Trading Market, it will then include in such application all of the Shares, and will take such other action as is necessary to cause all of the Shares to be listed or quoted on such other Trading Market as promptly as possible. The Company will then take all action reasonably necessary to continue the listing and trading of its Common Stock on a Trading Market and will comply in all respects with the Company’s reporting, filing and other obligations under the bylaws or rules of the Trading Market. The Company agrees to maintain the eligibility of the Common Stock for electronic transfer through the Depository Trust Company or another established clearing corporation, including, without limitation, by timely payment of fees to the Depository Trust Company or such other established clearing corporation in connection with such electronic transfer.

4.7 Indemnification of the Purchaser. The Company will indemnify and hold the Purchaser and its directors, officers, shareholders, members, partners, employees and agents (and any other Persons with a functionally equivalent role of a Person holding such titles notwithstanding a lack of such title or any other title), each Person who controls such Purchaser (within the meaning of Section 15 of the Securities Act and Section 20 of the Exchange Act), and the directors, officers, shareholders, agents, members, partners or employees (and any other Persons with a functionally equivalent role of a Person holding such titles notwithstanding a lack of such title or any other title) of such controlling persons (each, a “Purchaser Party”) harmless from any and all losses, liabilities, obligations, claims, contingencies, damages, costs and expenses, including all judgments, amounts paid in settlements, court costs and reasonable attorneys’ fees and costs of investigation that any such Purchaser Party may suffer or incur as a result of or relating to (a) any breach of any of the representations, warranties, covenants or agreements made by the Company in this Agreement or in the other Transaction Documents, or (b) any action instituted against the Purchaser Parties in any capacity, or any of them or their respective Affiliates, by any stockholder of the Company who is not an Affiliate of such Purchaser Party, with respect to any of the transactions contemplated by the Transaction Documents (unless such action is solely based upon a material breach of such Purchaser Party’s representations, warranties or covenants under the Transaction Documents or any agreements or understandings such Purchaser Party may have with any such stockholder or any violations by such Purchaser Party of state or federal securities laws or any conduct by such Purchaser Party which is finally judicially determined to constitute fraud, gross negligence or willful misconduct). If any action shall be brought against any Purchaser Party in respect of which indemnity may be sought pursuant to this Agreement, such Purchaser Party shall promptly notify the Company in writing, and the Company shall have the right to assume the defense thereof with counsel of its own choosing reasonably acceptable to the Purchaser Party. Any Purchaser Party shall have the right to employ separate counsel in any such action and participate in the defense thereof, but the fees and expenses of such counsel shall be at the expense of such Purchaser Party except to the extent that (x) the employment thereof has been specifically authorized by the Company in writing, (y) the Company has failed after a reasonable period of time to assume such defense and to employ counsel or (z) in such action there is, in the reasonable opinion of counsel, a material conflict on any material issue between the position of the Company and the position of such Purchaser Party, in which case the Company shall be responsible for the reasonable fees and expenses of no more than one such separate counsel. The Company will not be liable to any Purchaser Party under this Agreement (1) for any settlement by a Purchaser Party effected without the Company’s prior written consent, which shall not be unreasonably withheld or delayed; or (2) to the extent, but only to the extent that a loss, claim, damage or liability is attributable to any Purchaser Party’s breach of any of the representations, warranties, covenants or agreements made by such Purchaser Party in this Agreement or in the other Transaction Documents. The indemnification required by this Section 4.7 shall be made by periodic payments of the amount thereof during the course of the investigation or defense, as and when bills are received or are incurred. The indemnity agreements contained herein shall be in addition to any cause of action or similar right of any Purchaser Party against the Company and any liabilities the Company may be subject to pursuant to law.

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ARTICLE V

MISCELLANEOUS

5.1 Termination. This Agreement may be terminated by the Company or the Purchaser by written notice to the other party, if the Closing has not been consummated on or before the 30th Trading Day following the date hereof.

5.2 Fees and Expenses. Except as expressly set forth in the Transaction Documents to the contrary, each party shall pay the fees and expenses of its advisers, counsel, accountants and other experts, if any, and all other expenses incurred by such party incident to the negotiation, preparation, execution, delivery and performance of this Agreement. The Company shall pay all Transfer Agent fees (including, without limitation, any fees required for same-day processing of any instruction letter delivered by the Company and any exercise notice delivered by a Purchaser). The Company shall pay any issuance, stamp or documentary taxes (other than transfer taxes) or charges imposed by any governmental body, agency or official (other than income taxes) by reason of the issuance of Shares to the Purchaser.

5.3 Entire Agreement. The Transaction Documents, together with the exhibits and schedules thereto, and the Prospectus Supplement contain the entire understanding of the parties with respect to the subject matter hereof and thereof and supersede all prior agreements and understandings, oral or written, with respect to such matters, which the parties acknowledge have been merged into such documents, exhibits and schedules.

5.4 Notices. Any and all notices or other communications or deliveries required or permitted to be provided hereunder shall be in writing and shall be deemed given and effective on the time of transmission by electronic mail.

5.5 Amendments; Waivers. No provision of this Agreement may be waived, modified, supplemented or amended except in a written instrument signed by the Company and the Purchaser. No waiver of any default with respect to any provision, condition or requirement of this Agreement shall be deemed to be a continuing waiver in the future or a waiver of any subsequent default or a waiver of any other provision, condition or requirement hereof, nor shall any delay or omission of any party to exercise any right hereunder in any manner impair the exercise of any such right. Any amendment effected in accordance with this Section 5.5 shall be binding upon the Purchaser and the Company.

5.6 Headings. The headings herein are for convenience only, do not constitute a part of this Agreement and shall not be deemed to limit or affect any of the provisions hereof.

5.7 Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the parties and their successors and permitted assigns. No party hereto may assign this Agreement or any rights or obligations hereunder without the prior written consent of the Company and the Purchaser.

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5.8 Third-Party Beneficiaries. This Agreement is intended for the benefit of the parties hereto and their respective successors and permitted assigns and is not for the benefit of, nor may any provision hereof be enforced by, any other Person.

5.9 Governing Law. All questions concerning the construction, validity, enforcement and interpretation of the Transaction Documents shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles of conflicts of law thereof. Each party agrees that all legal proceedings concerning the interpretations, enforcement and defense of the transactions contemplated by this Agreement and any other Transaction Documents (whether brought against a party hereto or its respective affiliates, directors, officers, shareholders, partners, members, employees or agents) shall be commenced exclusively in the state and federal courts sitting in the City of New York. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in the City of New York, Borough of Manhattan for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein (including with respect to the enforcement of any of the Transaction Documents), and hereby irrevocably waives, and agrees not to assert in any action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such action or proceeding is improper or is an inconvenient venue for such proceeding. Each party hereby irrevocably waives personal service of process and consents to process being served in any such action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Agreement and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by law. If any party shall commence an action or proceeding to enforce any provisions of the Transaction Documents, then the prevailing party in such action or proceeding shall be reimbursed by the non-prevailing party for its reasonable attorneys’ fees and other costs and expenses incurred with the investigation, preparation and prosecution of such action or proceeding.

5.10 Survival. The representations and warranties contained herein shall survive the Closing and the delivery of the Securities.

5.11 Execution. This Agreement may be executed in two or more counterparts, all of which when taken together shall be considered one and the same agreement and shall become effective when counterparts have been signed by each party and delivered to each other party, it being understood that the parties need not sign the same counterpart. In the event that any signature is delivered by facsimile transmission or by e-mail delivery of a “.pdf” format data file, by other electronic signing created on an electronic platform (such as DocuSign) or by digital signing (such as Adobe Sign), such signature shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or “.pdf” signature page were an original thereof.

5.12 Severability. If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction to be invalid, illegal, void or unenforceable, the remainder of the terms, provisions, covenants and restrictions set forth herein shall remain in full force and effect and shall in no way be affected, impaired or invalidated, and the parties hereto shall use their commercially reasonable efforts to find and employ an alternative means to achieve the same or substantially the same result as that contemplated by such term, provision, covenant or restriction. It is hereby stipulated and declared to be the intention of the parties that they would have executed the remaining terms, provisions, covenants and restrictions without including any of such that may be hereafter declared invalid, illegal, void or unenforceable.

5.13 Saturdays, Sundays, Holidays, etc. If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall not be a Trading Day, then such action may be taken or such right may be exercised on the next succeeding Trading Day.

5.14 Construction. The parties agree that each of them and/or their respective counsel have reviewed and had an opportunity to revise the Transaction Documents and, therefore, the normal rule of construction to the effect that any ambiguities are to be resolved against the drafting party shall not be employed in the interpretation of the Transaction Documents or any amendments thereto. In addition, each and every reference to share prices and Common Stock in any Transaction Document shall be subject to adjustment for reverse and forward stock splits, stock dividends, stock combinations and other similar transactions of the Common Stock that occur after the date of this Agreement.

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5.16 WAIVER OF JURY TRIAL. IN ANY ACTION, SUIT, OR PROCEEDING IN ANY JURISDICTION BROUGHT BY ANY PARTY AGAINST ANY OTHER PARTY, THE PARTIES EACH KNOWINGLY AND INTENTIONALLY, TO THE GREATEST EXTENT PERMITTED BY APPLICABLE LAW, HEREBY ABSOLUTELY, UNCONDITIONALLY, IRREVOCABLY AND EXPRESSLY WAIVES FOREVER TRIAL BY JURY.

(Signature Pages Follow)

17


IN WITNESS WHEREOF, the parties hereto have caused this Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.

VAXART, INC.
By: /s/ [***]
Name: [***]
Title: [***]
Address for Notice:<br><br> <br>170 Harbor Way, Ste 300<br><br> <br>South San Francisco, California 94080<br><br> <br>Email: [***]<br><br> <br>Phone: (650) 550-3500<br><br> <br><br><br> <br>With a copy to (which shall not constitute notice):<br><br> <br><br><br> <br>Faith L. Charles, Esq.<br><br> <br>300 Madison Avenue, 27th Floor<br><br> <br>New York, New York 10017-6232<br><br> <br>Email: [***]<br><br> <br>Phone: (212) 344-5680

[COMPANY SIGNATURE PAGE TO

SECURITIES PURCHASE AGREEMENT]


IN WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.

DYNAVAX TECHNOLOGIES CORPORATION
By: /s/ [***]
Name: [***]
Title: [***]

Address for Notice:

2100 Powell Street, Suite 720

Emeryville, California 94608

Email: [***]

Phone: (510) 848-5100

With a copy to (which shall not constitute notice):

Steven M. Przesmicki

Cooley LLP

10265 Science Center Dr

San Diego, CA 92121

Email: [***]

Phone: (858) 550-6070

[COMPANY SIGNATURE PAGE TO

SECURITIES PURCHASE AGREEMENT]


ANNEX A

Subscription Amount

Name of Purchaser: Dynavax Technologies Corporation

Subscription Amount: $5,000,000

Shares: 11,111,111 Shares

Price Per Share: $0.45


EXHIBIT A-1

Form of Officers Certificate

(See attached)


EXHIBIT A-2

Form of Secretarys Certificate

(See attached)

ex_856471.htm

Exhibit 31.1

CERTIFICATION


I, Steven Lo, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Vaxart, 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: November 13, 2025 By: /s/ STEVEN LO
--- --- ---
**** Steven Lo
President and Chief Executive Officer
( P rincipal E xecutive O fficer )

ex_856472.htm

Exhibit 31.2

CERTIFICATION


I, Jeroen Grasman, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Vaxart, 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: November 13, 2025 By: /s/ JEROEN GRASMAN
--- --- ---
**** Jeroen Grasman
Chief Financial Officer
( P rincipal Financial and Accounting O fficer )

ex_856473.htm

Exhibit 32.1

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, Steven Lo, President and Chief Executive Officer of Vaxart, Inc. (the “Company”), and Jeroen Grasman, Chief Financial Officer of the Company, hereby certify that, to their knowledge:

(1) The Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2025, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
--- ---
Date: November 13, 2025 By: /s/ STEVEN LO
--- --- ---
**** Steven Lo
President and Chief Executive Officer
( P rincipal E xecutive O fficer )
Date: November 13, 2025 By: /s/ JEROEN GRASMAN
--- --- ---
**** Jeroen Grasman
Chief Financial Officer
( P rincipal Financial and Accounting **** O fficer )

A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to Vaxart, Inc. and will be retained by Vaxart, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.