GeoVax Labs, Inc 10-Q for FY2024 Q2
GeoVax Labs, Inc. (GOVX)
About this 10-Q
GeoVax Labs, Inc filed this 10-Q on August 6, 2024, covering the quarter ended June 30, 2024 (FY2024 Q2).
Headline figures
Quarter ended June 30, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $300.68K
- compared with $0 a year earlier
- Net loss
- $5.06M
- compared with a net loss of $5.93M a year earlier
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
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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:
(Exact name of registrant as specified in its charter)
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(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
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Name of each Exchange on which Registered |
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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.
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).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non‑accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ | |
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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
As of August 6, 2024,
TABLE OF CONTENTS
Page
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PART I – FINANCIAL INFORMATION |
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Item 1 |
Condensed Consolidated Financial Statements: |
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Condensed Consolidated Balance Sheets as of June 30, 2024 (unaudited) and December 31, 2023 |
1 |
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Condensed Consolidated Statements of Operations for the three-month and six-month periods ended June 30, 2024 and 2023 (unaudited) |
2 |
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Condensed Consolidated Statements of Changes in Stockholders’ Equity for the three-month and six-month periods ended June 30, 2024 and 2023 (unaudited) |
3 |
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Condensed Consolidated Statements of Cash Flows for the six-month periods ended June 30, 2024 and 2023 (unaudited) |
4 |
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Notes to Condensed Consolidated Financial Statements (unaudited) |
5 |
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Item 2 |
Management's Discussion and Analysis of Financial Condition and Results of Operations |
9 |
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Item 3 |
Quantitative and Qualitative Disclosures about Market Risk |
15 |
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Item 4 |
Controls and Procedures |
15 |
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PART II – OTHER INFORMATION |
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Item 1 |
Legal Proceedings |
16 |
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Item 1A |
Risk Factors |
16 |
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Item 2 |
Unregistered Sales of Equity Securities and Use of Proceeds |
16 |
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Item 3 |
Defaults Upon Senior Securities |
16 |
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Item 4 |
Mine Safety Disclosures |
16 |
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Item 5 |
Other Information |
16 |
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Item 6 |
Exhibits |
17 |
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SIGNATURES |
18 |
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Part I -- FINANCIAL INFORMATION
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Item 1 |
Financial Statements |
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GEOVAX LABS, INC. |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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June 30, |
December 31, |
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2024 |
2023 |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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Accounts receivable |
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Prepaid expenses |
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Total current assets |
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Property and equipment, net |
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Other assets |
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Total assets |
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LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) |
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Current liabilities: |
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Accounts payable |
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Notes payable and accrued interest – related parties |
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Accrued expenses |
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Total current liabilities |
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Commitments (Note 5) |
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Stockholders’ equity (deficit): |
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Common stock, $ par value: |
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Authorized shares – |
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Issued and outstanding shares – |
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Additional paid-in capital |
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Accumulated deficit |
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Total stockholders’ equity (deficit) |
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Total liabilities and stockholders’ equity (deficit) |
$ | $ | ||||||
See accompanying notes to condensed consolidated financial statements.
GEOVAX LABS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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Three Months Ended June 30, |
Six Months Ended June 30, |
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2024 |
2023 |
2024 |
2023 |
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Revenue from government contract |
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Operating expenses: |
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Research and development |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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Other income (expense): |
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Interest income |
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Interest expense |
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Total other income (expense) |
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Net loss |
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Basic and diluted: |
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Net loss per common share |
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Weighted average shares outstanding |
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See accompanying notes to condensed consolidated financial statements.
GEOVAX LABS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
(Unaudited)
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Three-Month and Six-Month Periods Ended June 30, 2024 |
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Total |
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Common Stock |
Additional |
Accumulated |
Stockholders’ |
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Shares |
Amount |
Paid-in Capital |
Deficit |
Equity |
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Balance at December 31, 2023 |
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Issuance of common stock for services |
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Issuance of common stock upon warrant exercises |
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Fractional share roundup following reverse split |
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Stock option expense |
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Net loss for the three months ended March 31, 2024 |
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Balance at March 31, 2024 |
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Sale of common stock and warrants for cash |
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Issuance of common stock upon warrant exercises |
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Stock option expense |
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Net loss for the three months ended June 30, 2024 |
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Balance at June 30, 2024 |
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Three-Month and Six-Month Periods Ended June 30, 2023 |
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Total |
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Common Stock |
Additional |
Accumulated |
Stockholders’ |
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Shares |
Amount |
Paid-in Capital |
Deficit |
Equity |
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Balance at December 31, 2022 |
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Issuance of common stock for services |
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Stock option expense |
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Net loss for the three months ended March 31, 2023 |
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Balance at March 31, 2023 |
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Stock option expense |
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Net loss for the three months ended June 30, 2023 |
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Balance at June 30, 2023 |
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See accompanying notes to condensed consolidated financial statements.
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GEOVAX LABS, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) |
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Six Months Ended June 30, |
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2024 |
2023 |
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Cash flows from operating activities: |
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Net loss |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization expense |
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Stock-based compensation expense |
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Changes in assets and liabilities: |
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Accounts receivable |
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Prepaid expenses and other current assets |
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Other assets |
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Accounts payable and accrued expenses |
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Total adjustments |
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Net cash used in operating activities |
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Cash flows from investing activities: |
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Purchase of equipment |
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Net cash used in investing activities |
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Cash flows from financing activities: |
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Net proceeds from issuance of notes payable – related parties |
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Net proceeds from sale of common stock and warrants |
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Net proceeds from warrant exercise |
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Net cash provided by financing activities |
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Net decrease in cash and cash equivalents |
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period |
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Supplemental disclosure of non-cash financing activities:
During the six months ended June 30, 2024, we issued 2,549 shares of common stock upon the cashless exercise of 4,000 warrants.
See accompanying notes to condensed consolidated financial statements.
GEOVAX LABS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2024
(unaudited)
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1. |
Nature of Business |
GeoVax Labs, Inc., headquartered in the Atlanta, Georgia metropolitan area, is a clinical-stage biotechnology company incorporated under the laws of the State of Delaware. GeoVax Labs, Inc. and its wholly owned subsidiary, GeoVax, Inc., a Georgia corporation, are collectively referred to herein as “GeoVax” or “the Company”.
The Company is focused on developing human vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers using novel proprietary platforms. GeoVax’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which it was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In addition, the lead oncological clinical program is Gedeptin®, a novel oncolytic solid tumor gene-directed therapy, which is currently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. Additional preclinical research and development programs include preventive vaccines against Mpox (formerly known as monkeypox), hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, and Marburg), and Zika virus, as well as immunotherapies for solid tumors.
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2. |
Summary of Significant Accounting Policies |
We disclosed in Note 2 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023 those accounting policies that we consider significant in determining our results of operations and financial position. During the six months ended June 30, 2024, there have been no material changes to, or in the application of, the accounting policies previously identified and described in the Form 10-K.
Basis of Presentation
The accompanying financial statements include the accounts of GeoVax Labs, Inc. and GeoVax, Inc. All intercompany transactions have been eliminated in consolidation. The financial statements are unaudited, but include all adjustments, consisting of normal recurring entries, which we believe to be necessary for a fair presentation of interim periods presented. Interim results are not necessarily indicative of results for a full year. The financial statements should be read in conjunction with our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023. We expect our operating results to fluctuate for the foreseeable future; therefore, period-to-period comparisons should not be relied upon as predictive of the results in future periods.
We are devoting substantially all of our present efforts to research and development of our vaccine and immunotherapy candidates and will require additional funding to continue our research and development activities. Our existing cash resources are insufficient to continue our planned operations beyond the third quarter of 2024 without additional funding, which we are actively pursuing. We plan to pursue additional cash resources through public or private equity or debt financings, government grants/contracts, arrangements with strategic partners, or from other sources. There can be no assurance that additional funding will be available on favorable terms or at all. These factors collectively raise substantial doubt about the Company’s ability to continue as a going concern. Management believes that we will be successful in securing the additional capital required to continue the Company’s planned operations, but that our plans do not fully alleviate the substantial doubt about the Company’s ability to operate as a going concern.
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.
The accompanying consolidated financial statements, and all share and per share information contained herein, have been retroactively restated to reflect the reverse stock split described in Note 6.
Recent Accounting Pronouncements
During the six months ended June 30, 2024, there have been no new accounting pronouncements or changes in accounting pronouncements which we expect to have a material impact on our financial statements.
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3. |
Balance Sheet Components |
Prepaid Expenses – Prepaid expenses consist of the following:
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June 30, 2024 |
December 31, 2023 |
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Prepaid clinical trial costs (current portion) |
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Prepaid insurance premiums |
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Prepaid rent |
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Other prepaid expenses |
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Total prepaid expenses |
$ | $ | ||||||
Property and Equipment – Property and equipment consist of the following:
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June 30, 2024 |
December 31, 2023 |
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Equipment and furnishings |
$ | $ | ||||||
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Leasehold improvements |
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Total property and equipment |
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Accumulated depreciation and amortization |
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Total property and equipment, net |
$ | $ | ||||||
Other Assets – Other assets consist of the following:
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June 30, 2024 |
December 31, 2023 |
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Prepaid clinical trial costs (noncurrent portion) |
$ | $ | ||||||
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Prepaid technology license fees |
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Deposits |
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Total other assets |
$ | $ | ||||||
Accrued Expenses – Accrued expenses consist of the following:
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June 30, 2024 |
December 31, 2023 |
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Payroll-related liabilities |
$ | $ | ||||||
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Accrued clinical trial costs |
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Accrued contract manufacturing costs |
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Other accrued expenses |
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Total accrued expenses |
$ | $ | ||||||
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4. |
Notes Payable – Related Parties |
On May 10, 2024, we issued
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5. |
Commitments |
Operating Lease. We lease approximately
License Agreements. We have entered into license agreements for various technologies and patent rights associated with our product development activities. These agreements may contain provisions for upfront payments, milestone fees due upon the achievement of selected development and regulatory events, minimum annual royalties or other fees, and royalties based on future net sales. Due to the uncertainty of the achievement and timing of the contingent events requiring payment under these agreements, the amounts to be paid by us in the future are not determinable.
Other Commitments. In the normal course of business, we enter into various contracts and purchase commitments including those with contract research organizations (“CROs”) for clinical trial services, contract manufacturing organizations (“CMOs”) for production of materials for use in our clinical trials, and other independent contractors or academic institutions for preclinical research activities and other services and products. Most contracts are generally cancellable, with notice, at the Company’s option. Payments due upon cancellation may consist of payments for services provided or expenses incurred to date, or cancellation penalties depending on the time of cancellation.
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6. |
Stockholders’ Equity |
Reverse Stock Split and Reduction of Authorized Shares of Common Stock
At a special meeting of our stockholders held on January 16, 2024, our stockholders approved an amendment to our certificate of incorporation to (i) reduce our authorized shares of common stock from
May 2024 Offering
On May 21, 2024, we closed a registered direct offering of
Warrant Exercises
During the first quarter of 2024, we issued
Other Common Stock Transactions
During January 2024, we issued
Stock Options
We have stock-based incentive plans (the “Plans”) pursuant to which our Board of Directors may grant stock options and other stock-based awards to our employees, directors and consultants. During the six months ended June 30, 2024,
Stock Purchase Warrants
The table below summarizes information concerning warrants outstanding as of June 30, 2024.
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Issue Date |
Number of Shares |
Exercise Price |
Expiration |
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June 2020 |
$ |
June 2025 |
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September 2020 |
September 2025 |
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February 2021 |
August 2024 |
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September 2021 |
September 2026 |
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December 2023 |
June 2029 |
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May 2024 |
May 2029 |
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Outstanding at June 30, 2024 |
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7. |
Stock-Based Compensation Expense |
Stock-based compensation expense related to stock options is recognized on a straight-line basis over the requisite service period for the award and is allocated to research and development expense or general and administrative expense based upon the classification of the individual to whom the award is granted. Stock-based compensation expense related to stock option grants was $
We have also issued shares of our restricted common stock to consultants and recognize the related expense over the terms of the related agreements. During the three-month and six-month periods ended June 30, 2024 we recorded stock-based compensation expense of $-
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8. |
Revenue from Government Contract |
On June 12, 2024, GeoVax was awarded a contract (the “BARDA Contract”) through the Rapid Response Partnership Vehicle (RRPV) to advance the clinical development of GEO-CM04S1, the Company’s next-generation COVID-19 vaccine. The RRPV is a consortium funded by 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 (HHS).
Under the BARDA Contract, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to assess the clinical efficacy, safety, and immunogenicity of GEO-CM04S1 compared with a U.S. Food and Drug Administration (FDA)-approved mRNA COVID-19 vaccine. The direct award to GeoVax of approximately $
GeoVax’s role in the project is being funded in whole or in part with federal funds from BARDA under Other Transaction 75A50123D00005. Allucent’s role in the project is being funded in whole or in part with federal funds from BARDA under contract 75A50120D00016/75A50123F33005.
During the three-month and six-month periods ending June 30, 2024, GeoVax recognized revenue of $
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9. |
Net Loss Per Share |
Basic and diluted loss per common share are computed based on the weighted average number of common shares outstanding. The Company’s potentially dilutive securities, which include stock options and stock purchase warrants, have been excluded from the computation of diluted net loss per share as the effect would be antidilutive. The securities that could potentially dilute basic earnings per share in the future and that have been excluded from the computation of diluted net loss per share totaled
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10. |
Income Taxes |
provision for income taxes was recorded in either of the six-month periods ended June 30, 2024 and 2023. The Company remains in a cumulative loss position with a full valuation allowance recorded against its net deferred income tax assets as of June 30, 2024.
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11. |
Subsequent Events |
July 2024 Offering. On July 12, 2024, we closed a registered direct offering of
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Item 2 |
Management’s Discussion and Analysis of Financial Condition And Results of Operations |
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) is intended to help the reader understand our results of operations and financial condition. This MD&A is provided as a supplement to, and should be read in conjunction with, our condensed consolidated financial statements and the accompanying notes thereto and other disclosures included in this Quarterly Report on Form 10-Q (this “Quarterly Report”), and our audited financial statements and the accompanying notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the Securities and Exchange Commission (the “SEC”) on February 29, 2024.
Forward-Looking Statements
Information included in this Quarterly Report 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 (the “Exchange Act”). Forward-looking statements are not statements of historical facts, but rather reflect our current expectations concerning future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. All statements in this Quarterly Report, other than statements of historical facts, including statements regarding our strategy, future operations, future financial position, future revenues, future governmental grants, projected costs, prospects, plans, intentions, expectations and objectives could be forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. We operate in a highly competitive, highly regulated and rapidly changing environment and our business is constantly evolving. Therefore, it is likely that new risks will emerge, and that the nature and elements of existing risks will change, over time. It is not possible for management to predict all such risk factors or changes therein, or to assess either the impact of all such risk factors on our business. We assume no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this Quarterly Report.
Overview
GeoVax is a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases using novel vector vaccine platforms. GeoVax’s product pipeline includes ongoing human clinical trials for a next-generation COVID-19 vaccine and a gene-directed therapy against advanced head and neck cancer. Additional preclinical research and development programs include preventive vaccines against Mpox (formerly known as monkeypox), hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, and Marburg), and Zika virus, as well as immunotherapies for solid tumors.
Our corporate strategy is to advance, protect and exploit our differentiated vaccine/immunotherapy technologies leading to the successful development of preventive and therapeutic vaccines and immunotherapies against infectious diseases and various cancers. Our goal is to advance products through to human clinical testing, and to seek partnership or licensing arrangements for achieving regulatory approval and commercialization. We also leverage third party resources through collaborations and partnerships for preclinical and clinical testing with multiple government, academic and corporate entities.
Our programs are in various stages of development, the most significant of which are summarized below along with recent developments:
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GEO-CM04S1 – Next Generation COVID-19 Vaccine: |
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○ |
On June 12, 2024, GeoVax was awarded a contract (the “BARDA Contract”) through the Rapid Response Partnership Vehicle (RRPV) to advance the clinical development of GEO-CM04S1. The RRPV is a Consortium funded by 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 (HHS). Under the agreement, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to assess the clinical efficacy, safety, and immunogenicity of GEO-CM04S1 compared with a U.S. Food and Drug Administration (FDA)-approved mRNA COVID-19 vaccine. The original direct award to GeoVax of approximately $24.3 million, which may increase to as much as $45 million, will fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities. BARDA has made a separate award of approximately $343 million through its Clinical Studies Network to Allucent, a global clinical research organization, to execute the clinical trial as part of BARDA’s Clinical Studies Network. |
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○ |
GEO-CM04S1 is currently undergoing a Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04977024), evaluating its safety and efficacy as a preventive COVID-19 vaccine in high-risk immunocompromised patients (i.e. patients with blood cancers who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy). Data published from the safety lead-in portion of the trial indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing broad and durable neutralizing antibody and T cell responses. |
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○ |
GEO-CM04S1 is also undergoing the Phase 2 portion of a Phase 1/2 trial (ClinicalTrials.gov Identifier: NCT04639466), evaluating two vaccine dose levels as a heterologous COVID-19 booster vaccine to current FDA-approved mRNA vaccines from Pfizer/BioNTech and Moderna. In February 2024, we announced positive interim safety and immune responses findings following vaccine administration. Consolidated data (blinded to vaccine dose) from all subjects tested one-month post-vaccination, documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5. |
|
○ |
An investigator-initiated Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT05672355) of GEO-CM04S1 is evaluating its use as a COVID-19 vaccine booster in patients with chronic lymphocytic leukemia (CLL) compared to the Pfizer/BioNTech mRNA-based vaccine. |
|
● |
Gedeptin® - Advanced Head and Neck Cancer Phase 1/2 Trial: |
|
○ |
Gedeptin recently completed a Phase 1/2 clinical trial (PNP-002) (ClinicalTrials.gov Identifier: NCT03754933) for treatment of patients with advanced head and neck squamous cell carcinoma (HNSCC). This trial is being funded in part by the U.S. Food & Drug Administration (FDA) pursuant to its Orphan Products Clinical Trials Grants Program. |
|
○ |
We recently convened a special clinical advisory board to conduct a comprehensive review of the PNP-002 trial results, together with the previously completed Phase 1 trial (PNP-001). This review concluded that Gedeptin demonstrated an acceptable safety and efficacy profile to support continued development. In addition, the therapy has demonstrated sufficient tumor stabilization/reduction activity to support plans to advance clinical development of Gedeptin therapy in an expanded Phase 2 clinical trial. |
|
○ |
We have initiated activities in support of a Phase 2 trial in first-recurrence head and neck cancer. The primary goal of this trial will be to establish efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in squamous cell head and neck cancer. This trial is anticipated to be a single cycle trial with surgery to follow in approximately 36 patients with pathologic response rate as the primary endpoint. We have initiated the necessary planning activities, including protocol development, manufacturing and CRO selection, with the trial activation anticipated during the first half of 2025. |
|
● |
Our additional research programs for vaccines and immunotherapies at various stages of preclinical development. |
|
● |
General Corporate: |
|
○ |
On May 23, 2024, we received a notice from the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) notifying the Company that it no longer complied with the $2,500,000 minimum stockholders’ equity required for continued listing pursuant to Nasdaq Listing Rule 5550(b)(1) (the “Stockholders’ Equity Requirement”), because the Company’s stockholders’ equity as reported in its Form 10-Q for the period ended March 31, 2024 did not meet the required minimum. On July 18, 2024, we received notice from Nasdaq granting our request for an extension of time to regain compliance with the Stockholders’ Equity Requirement until November 19, 2024. We are currently reviewing potential transactions that, if implemented, could remedy the shortfall in our stockholders’ equity. There can be no assurance, however, whether we will be able to remedy the non-compliance. |
Financial Overview
Revenue
Our revenues to date have been related to government grants and contracts and other collaborative arrangements in support of our product development activities. We have not generated any revenue to date from the sale of the products we are developing. Our product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing. All product candidates that we advance to clinical testing will require regulatory approval prior to commercial use and will require significant costs for commercialization.
Research and development expenses
Since our inception, we have focused and we continue to focus significant resources on our research and development activities, including developing our vector platform and analytical testing methods, conducting preclinical studies, developing manufacturing processes, and conducting clinical trials. Research and development costs are expensed as incurred and consist primarily of the following:
|
• |
personnel costs in our research, development and regulatory functions, which include salaries, benefits and stock-based compensation; |
|
• |
expenses incurred under agreements with contract research organizations (“CROs”), that conduct clinical trials on our behalf; |
|
• |
expenses incurred under agreements with contract manufacturing organizations (“CMOs”), that manufacture product used in the clinical trials; |
|
• |
expenses incurred in procuring materials and for analytical and release testing services required to produce vaccine candidates used in clinical trials; |
|
• |
process development expenses to improve the efficiency and yield of the bulk vaccine; |
|
• |
laboratory supplies, vendor expenses and other third-party contract expenses related to preclinical research activities; |
|
• |
technology license fees; |
|
• |
consultant expenses for services supporting our clinical, regulatory and manufacturing activities; and |
|
• |
facilities, depreciation and other general overhead expenses. |
We expect our research and development expenditures to increase as we advance our existing and future product candidates into and through clinical trials and pursue regulatory approval, especially with regard to the Gedeptin and GEO-CM04S1 clinical programs. We do not provide forward-looking estimates of costs and time to complete our research programs due to the many uncertainties associated with biotechnology research and development. Due to these uncertainties, our future expenditures are likely to be highly volatile in future periods depending on the outcomes of the trials and studies. As we obtain data from preclinical studies and clinical trials, we may elect to discontinue or delay certain development programs to focus our resources on more promising product candidates. Completion of preclinical studies and human clinical trials may take several years or more, but the length of time can vary substantially depending upon several factors. The duration and the cost of future clinical trials may vary significantly over the life of the project because of differences arising during development of the human clinical trial protocols, including the length of time required to enroll suitable patient subjects, the number of patients that ultimately participate in the clinical trial, the duration of patient follow-up, and the number of clinical sites included in the clinical trials.
General and administrative expenses
Our general and administrative expenses consist primarily of personnel costs in our executive, finance and investor relations, business development and administrative functions, including stock-based compensation. Other general and administrative expenses include consulting fees, professional service fees for accounting and legal services, lease expenses related to our offices, insurance premiums, intellectual property costs incurred in connection with filing and prosecuting patent applications, depreciation and other costs. We expect our general and administrative expenses to continue to increase in the future as we support expanded research and development activities, prepare for potential commercialization of our current and future product candidates, maintain compliance with requirements of Nasdaq and the SEC, and other general corporate activities.
Critical Accounting Policies and Estimates
This discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates and adjusts the estimates as necessary. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.
For a description of critical accounting policies that require significant judgments and estimates during the preparation of our financial statements, refer to the Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2023. There have been no significant changes to our critical accounting policies from those disclosed in our 2023 Annual Report.
Recent Accounting Pronouncements – Information regarding recent accounting pronouncements is contained in Note 2 to the condensed consolidated financial statements, included in this Quarterly Report.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements that are likely or reasonably likely to have a material effect on our financial condition or results of operations, other than the operating lease for our office and laboratory space.
Results of Operations
The following table summarizes our results of operations for the three-month and six-month periods ended June 30, 2024 and 2023:
|
Three Months Ended June 30, |
||||||||||||
|
2024 |
2023 |
Change |
||||||||||
|
Revenue from government contract |
$ | 300,677 | $ | - | $ | 300,677 | ||||||
|
Operating expenses: |
||||||||||||
|
Research and development |
4,276,868 | 4,719,728 | (442,860 | ) | ||||||||
|
General and administrative |
1,086,030 | 1,459,093 | (373,063 | ) | ||||||||
|
Total operating expenses |
5,362,898 | 6,178,821 | (815,923 | ) | ||||||||
|
Loss from operations |
(5,062,221 | ) | (6,178,821 | ) | 1,116,600 | |||||||
|
Interest income |
5,471 | 251,201 | (245,730 | ) | ||||||||
|
Interest expense |
(7,292 | ) | - | (7,292 | ) | |||||||
|
Net loss |
$ | (5,064,042 | ) | $ | (5,927,620 | ) | $ | 863,578 | ||||
|
Six Months Ended June 30, |
||||||||||||
|
2024 |
2023 |
Change |
||||||||||
|
Revenue from government contract |
$ | 300,677 | $ | - | $ | 300,677 | ||||||
|
Operating expenses: |
||||||||||||
|
Research and development |
8,702,596 | 7,538,917 | 1,163,679 | |||||||||
|
General and administrative |
2,543,383 | 2,910,518 | (367,135 | ) | ||||||||
|
Total operating expenses |
11,245,979 | 10,449,435 | 796,544 | |||||||||
|
Loss from operations |
(10,945,302 | ) | (10,449,435 | ) | (495,867 | ) | ||||||
|
Interest income |
38,420 | 483,899 | (445,479 | ) | ||||||||
|
Interest expense |
(7,292 | ) | - | (7,292 | ) | |||||||
|
Net loss |
$ | (10,914,174 | ) | $ | (9,965,536 | ) | $ | (948,638 | ) | |||
Revenue from Government Contract
During the three-month and six-month periods ending June 30, 2024, we reported $300,677 of revenues associated with the BARDA Contract. There were no revenues reported during the comparable 2023 periods.
Research and Development Expenses
For the three-month and six-month periods ending June 30, 2024, research and development expenses decreased by $442,860 (9.4%) and increased by $1,163,679 (15.4%), respectively, versus the comparable 2023 periods. The overall increase during the six-month period of 2024 versus 2023 relates primarily to costs of manufacturing materials for use in our clinical trials of GEO-CM04S1 and Gedeptin and costs of various contracted research activities. Research and development expenses for the three-month and six-month periods of 2024 includes stock-based compensation expense of $51,170 and $104,269, respectively; as compared to $76,770 and $154,643, respectively, for the comparable 2023 periods.
General and Administrative Expenses
For the three-month and six-month periods ending June 30, 2024, general and administrative expenses decreased by $373,063 (25.6%) and $367,135 (12.6%), respectively, versus the comparable 2023 periods. The overall decrease during the 2024 periods relates primarily to lower stock-based compensation expense, consulting costs, legal and patent costs and travel costs. General and administrative expenses for the three-month and six-month periods of 2024 includes stock-based compensation expense of $50,471 and $155,107, respectively; as compared to $192,743 and $360,909, respectively, for the comparable periods of 2023.
Other Income
Interest income for the three-month and six-month periods ended June 30, 2024 was $5,471 and $38,420, respectively, as compared to $251,201 and $483,899, respectively, for comparable periods of 2023. The overall decrease during the 2024 periods is primarily attributable to cash available for investment. Interest expense for the three-month and six-month periods ended June 30, 2024 was $7,292, associated with certain notes payable issued during May 2024. There was no interest expense during the comparable periods of 2023.
Liquidity and Capital Resources
The following tables summarize our liquidity and capital resources as of June 30, 2024 and December 31, 2023, and our cash flows for the six-month periods ended June 30, 2024 and 2023:
|
Liquidity and Capital Resources |
June 30, 2024 |
December 31, 2023 |
||||||
|
Cash and cash equivalents |
$ | 1,561,712 | $ | 6,452,589 | ||||
|
Working capital (deficit) |
(2,560,773 | ) | 4,365,861 | |||||
|
Six Months Ended June 30, |
||||||||
|
Cash Flow Data |
2024 |
2023 |
||||||
|
Net cash provided by (used in): |
||||||||
|
Operating activities |
$ | (7,624,778 | ) | $ | (9,800,016 | ) | ||
|
Investing activities |
- | (23,805 | ) | |||||
|
Financing activities |
2,733,901 | - | ||||||
|
Net decrease in cash and cash equivalents |
$ | (4,890,877 | ) | $ | (9,823,821 | ) | ||
Operating Activities – Net cash used in operating activities of $7,624,778 for the six months ended June 30, 2024, was primarily due to our net loss of $10,914,174, offset by non-cash items such as depreciation and amortization expense and stock-based compensation expense, and by changes in our working capital accounts. Net cash used in operating activities of $9,800,016 for the six months ended June 30, 2023, was primarily due to our net loss of $9,965,536, offset by non-cash items such as depreciation expense and stock-based compensation expense, and by changes in our working capital accounts.
Investing Activities – Net cash used in investing activities was $-0- and $23,805 for the six-month periods ended June 30, 2024 and 2023, respectively, and relates primarily to purchases of laboratory equipment.
Financing Activities – Net cash provided by financing activities was $2,733,901 and $-0- for the six-month periods ended June 30, 2024 and 2023, respectively. Net cash provided by financing activities for the 2024 period relates to net proceeds from issuance of notes payable, offerings of our common stock and warrants, and exercise of previously issued warrants.
Funding Requirements and Sources of Capital
To date, we have not generated any product revenue. We do not know when, or if, we will generate any product revenue and we do not expect to generate significant product revenue unless and until we obtain regulatory approval and commercialize one of our current or future product candidates. We anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates, and begin to commercialize any approved products. We are subject to all of the risks incident to the development of new products, and may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. We anticipate that we will need substantial additional funding in connection with our continuing operations. We have funded our operations to date primarily from sales of our equity securities and from government grants and clinical trial assistance.
On July 12, 2024, we closed an offering of our common stock and warrants (see footnote 11 to the financial statements included in this Quarterly Report). Net proceeds to us after deducting placement agent commissions and other offering expenses were approximately $2.8 million.
As of the date of this Quarterly Report, our existing cash and cash equivalents are insufficient to fund our operations beyond the third quarter of 2024 without additional funding, which we are actively pursuing. We plan to pursue additional cash resources through public or private equity or debt financings, government grants/contracts, arrangements with strategic partners, or from other sources.
There can be no assurance that necessary funding will be available on favorable terms or at all. These factors collectively raise substantial doubt about the Company’s ability to continue as a going concern. Management believes that we will be successful in securing the additional capital required to continue the Company’s planned operations, but that our plans do not fully alleviate the substantial doubt about the Company’s ability to operate as a going concern.
We will need to continue to raise additional capital to support our future operating activities, including progression of our development programs, preparation for commercialization, and other operating costs. 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.
Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties and is based on assumptions that may prove to be wrong; actual results could vary materially. Our projection takes into consideration contractual commitments we have made, and expect to make, in the normal course of operating our business, which include (i) obligations to our employees, (ii) our lease obligations, (iii) payments due under license agreements for various technologies and patent rights associated with our product development activities, (iv) arrangements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and other third-party vendors for clinical trials services and production of materials for use in our clinical trials, and (v) other various firm purchase commitments and contractual obligations related to production and testing of our product candidates and the general operation of our business.
We have based our projections of operating capital requirements on assumptions that may prove to be incorrect, and we may use our available capital resources sooner than we expect. Our future capital requirements will depend on many factors, which include but are not limited to:
|
● |
the timing and costs of our ongoing and planned clinical trials; |
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● |
the timing and costs of manufacturing material for use in clinical trials; |
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● |
the number and scope of our research programs and the speed at which they are advanced; |
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● |
the progress and success of our preclinical and clinical development activities; |
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● |
the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; |
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● |
the costs to attract and retain skilled personnel; |
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● |
the costs to maintain and expand our infrastructure to support our operations, our product development, and planned future commercialization efforts; |
|
● |
the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; |
|
● |
the costs associated with any products or technologies that we may in-license or acquire; and |
|
● |
the costs and timing of regulatory approvals. |
|
Item 3 |
Quantitative and Qualitative Disclosures About Market Risk |
Not applicable to smaller reporting companies.
|
Item 4 |
Controls and Procedures |
Evaluation of disclosure controls and procedures
Disclosure controls and procedures are controls and other procedures that are designed to ensure that the information required to be disclosed in reports filed or submitted under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is (1) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to management, including the Chief Executive Officer and Principal Financial and Accounting Officer, as appropriate to allow timely decisions regarding required disclosure.
Our management has carried out an evaluation, under the supervision and with the participation of our Principal Executive Officer and our Principal Financial and Accounting Officer, of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Exchange Act Rules 13a-15 or 15d-15 as of the end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of the period covered by this report, our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms.
Changes in internal control over financial reporting
There were no significant changes in our internal control over financial reporting that occurred during the three months ended June 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations on Controls
Management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all error and fraud. Any control system, no matter how well designed and operated, is based upon certain assumptions and can provide only reasonable, not absolute, assurance that its objectives will be met. Further, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, within the Company have been detected.
PART II -- OTHER INFORMATION
|
Item1 |
Legal Proceedings |
None.
|
Item 1A |
Risk Factors |
For information regarding factors that could affect our results of operations, financial condition or liquidity, see the risk factors discussed under “Risk Factors” in Item 1A of our most recent Annual Report on Form 10-K. See also “Forward-Looking Statements,” included in Part I - Item 2 of this Quarterly Report on Form 10-Q. As a smaller reporting company (as defined in Rule 12b-2 of the Exchange Act), we are not required to provide the information called for by this Item 1A concerning any material changes from the risk factors previously disclosed in our most recent Annual Report on Form 10‑K.
|
Item 2 |
Unregistered Sales of Equity Securities and Use of Proceeds |
There were no sales of unregistered equity securities during the period covered by this report that have not previously been reported on Form 8-K.
|
Item 3 |
Defaults Upon Senior Securities |
None.
|
Item 4 |
Mine Safety Disclosures |
Not applicable.
|
Item 5 |
Other Information |
During the period covered by this report, of our directors or executive officers adopted or terminated any “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement” (as each term is defined in Item 408(a) of Regulation S-K).
During the period covered by this report, there was no information required to be disclosed by us in a Current Report on Form 8-K that was not so reported, nor were there any material changes to the procedures by which our security holders may recommend nominees to our board of directors.
|
Item 6 |
Exhibits |
|
Exhibit |
|
|
Number |
Description |
|
3.1 |
Restated Certificate of Incorporation filed April 12, 2024 (3) |
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3.2. |
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4.1 |
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4.2 |
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4.3 |
|
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4.4 |
|
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10.1* |
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10.2* |
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10.3 |
|
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10.4 |
|
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31.1* |
Certification pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934 |
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31.2* |
Certification pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934 |
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32.1* |
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32.2* |
|
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101.INS |
Inline XBRL Instance Document (1) |
|
101.SCH |
Inline XBRL Taxonomy Extension Schema Document (1) |
|
101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document (1) |
|
101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document (1) |
|
101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase Document (1) |
|
101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document (1) |
|
104 |
Inline XBRL for the cover page of this Quarterly Report on Form 10-Q and included in the Exhibit 101 Inline XBRL Document Set (1) |
|
* |
Filed herewith |
|
** |
Indicates a management contract or compensatory plan or arrangement |
|
(1) |
These interactive data files shall not be deemed filed or a part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, or Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability under these sections. |
|
(2) |
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 (ii) the Company customarily and actually treats the omitted information as private or confidential. |
|
(3) |
Incorporated by reference from the registrants Quarterly Report on Form 10-Q filed May 14, 2024. |
|
(4) |
Incorporated by reference from the registrant’s Current Report on Form 8-K filed May 21, 2024. |
|
(5) |
Incorporated by reference from the registrant’s Current Report on Form 8-K filed May 23, 2024. |
|
(6) |
Incorporated by reference from the registrant’s Current Report on Form 8-K filed July 12, 2024. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this quarterly report on Form 10-Q to be signed on its behalf by the undersigned thereunto duly authorized.
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|
|
GEOVAX LABS, INC. (Registrant) |
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|
|
Date: August 6, 2024 |
By: |
/s/ Mark W. Reynolds |
|
|
|
|
Chief Financial Officer (duly authorized officer and principal |
|
Exhibit 10.1
RRPV BASE AGREEMENT
BETWEEN
ADVANCED TECHNOLOGY INTERNATIONAL
315 SIGMA DRIVE
SUMMERVILLE, SC 29486
AND
RRPV Member Organization
GEOVAX, INC.
1900 Lake Park DR SE STE 380
Smyrna, Georgia 30080
UEI: CEF5ULT44LF5
RRPV Base Agreement No: 2024-564
Authority: RRPV Other Transaction Agreement 75A50123D00005 and 42 USC § 247d–7e(c)(5).
| Page 1 of 37 | October 2023 |
This Agreement is entered into between Advanced Technology International, hereinafter referred to as the “Consortium Management Firm (CMF)” and GEOVAX, INC. hereinafter referred to as “RRPV Member” or “Project Awardee”. This Agreement constitutes the entire understanding and agreement between the parties with respect to the subject matter hereof and supersedes all prior representations and agreements. It shall not be varied except by an instrument in writing of subsequent date duly executed by an authorized representative of each of the parties. The validity, construction, scope and performance of this Agreement shall be governed by the laws of the state of South Carolina, excluding its choice of laws rules.
| GEOVAX, INC. | Advanced Technology International | ||||
| By: | By: | ||||
| Name: | Mark Reynolds | Name: | |||
| Title: | Chief Financial Officer | Title: | |||
| Date: | April 1, 2024 | Date: | |||
| Page 2 of 37 | October 2023 |
Table of Contents
|
ARTICLE 1. PREAMBLE |
4 |
|
ARTICLE 2. DEFINITIONS |
5 |
|
ARTICLE 3. TECHNICAL FOCUS AREAS |
8 |
|
ARTICLE 4. REPORTS |
8 |
|
ARTICLE 5. FUNDING OBLIGATIONS AND PAYMENTS |
9 |
|
ARTICLE 6. ADMINISTRATION |
12 |
|
ARTICLE 7. PROPRIETARY INFORMATION |
15 |
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ARTICLE 8. RIGHTS IN DATA |
17 |
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ARTICLE 9. INVENTIONS |
19 |
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ARTICLE 10. FOREIGN ACCESS TO TECHNOLOGY |
23 |
|
ARTICLE 11. PUBLICATION AND PUBLICITY |
24 |
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ARTICLE 12. TERM OF AGREEMENT AND TERMINATION |
24 |
|
ARTICLE 13. CONSORTIUM MEMBERSHIP TERMS AND PROJECT AWARDS |
25 |
|
ARTICLE 14. REPRESENTATIONS AND WARRANTIES |
27 |
|
ARTICLE 15. LIABILITY OF THE PARTIES |
28 |
|
ARTICLE 16. DISPUTES |
29 |
|
ARTICLE 17. REGULATORY TERMS |
29 |
|
ARTICLE 18. GENERAL PROVISIONS |
34 |
ARTICLE 1. PREAMBLE
1.1. The Biomedical Advanced Research and Development Authority (BARDA) has entered into an Other Transaction Agreement (OTA) with Advanced Technology International (ATI) to form the Rapid Response Partnership Vehicle (RRPV) Consortium. The RRPV is a multiple-purpose acquisition vehicle designed to facilitate research and development (R&D) of future medical countermeasure (MCM) products, from early-stage development, through advanced development, procurement, sustainment, and commercialization, including manufacturing infrastructure development.
1.2. Under the RRPV OTA, the Government has partnered with the Consortium Management Firm (CMF), ATI, to establish and manage a consortium of pharmaceutical, medical, scientific, biomanufacturing, technology, and other related organizations working toward successful initiation and delivery of MCM materials and products to improve BARDA’s preparedness and response capabilities for future pandemics. The CMF facilitates cooperative partnerships with industry to ensure that the product and materials will be available to produce or be procured in advance of and during a public health incident (PHI) such that MCMs will be readily available to civilian populations.
1.3. The scope of the RRPV OTA collaborative effort includes:
1.3.1. Overseeing establishment and a new dynamic BARDA partnership vehicle centered around establishing a consortium built for the speed of response, leveraged for preparedness, and appropriately staffed;
1.3.2. Providing a vehicle to conduct projects for research & development (R&D), testing, related work, procurement, maintenance and improvement of domestic manufacturing surge capacity and capabilities, and any other activity BARDA is authorized to support, and
1.3.3. Providing comprehensive services to help rapidly advance BARDA mission-relevant technologies to address unmet needs and priorities from both the USG and entrepreneurial community.
1.4. The RRPV OTA is an Other Transaction Agreement as defined in 42 USC § 247d–7e(c)(5). The Federal Acquisition Regulations (“FAR”) does not apply to the OTA or this Agreement unless noted otherwise within this Agreement. The Parties agree that the principal purpose of this Agreement is to support all advancement of technology that falls within scope of the BARDA Mission and may result in projects to include any activity BARDA authorized under BARDA’s OT Authority.1
1.5. The applicable provisions of the OTA have been incorporated by the CMF into this Agreement and any forthcoming Project Awards with RRPV Members whose proposals have been selected by the Government for a Project Award.
1.6. In consideration of the foregoing, the Government, the CMF, and the Project Awardee agree to the mutual covenants and promises contained in this Agreement.
1 See 42 USC § 247d–7e(c)(5); 42 U.S.C. 247d-7e(c)(4)(D); 42 USC § 247d-7e(c)(4)(F)
ARTICLE 2. DEFINITIONS
2.1 When used in this Agreement, the following terms, whether used in the singular or plural, shall have the meanings set forth herein.
2.2 “Agreement” or "Base Agreement" means the agreement between the RRPV CMF and RRPV member that serves as the baseline agreement for all future funded Project Awards and flows down applicable terms and conditions from the Other Transaction Agreement between the Government and the CMF.
2.3 “BARDA Mission” means technology or action which BARDA is authorized by law2 to support. The BARDA Mission generally includes technologies which support the acceleration of countermeasures and advanced research and development against a broad array of public health threats, whether natural or intentional in origin. Specific detail of the BARDA Mission at the time of Agreement execution can be found in BARDA’s Strategic Plan (2022-2026), National Health Security Strategy (2023-2026), National Biodefense Strategy (2018), and the PHEMCE Strategy and Implementation Plan (2022), and by working directly with BARDA for specific information. The BARDA Mission is subject to change as laws, regulations and authorizations shift. Any statutory or regulatory updates to this authority are considered to be automatically incorporated into this Agreement.
2.4 “Cash Contribution” means the Project Awardee (or Awardees’ lower tier subawards) financial resources expended to perform a Project Award. The cash contribution may be derived from the Project Awardee (or a Project Awardees’ subawards) funds, outside sources, nonfederal contract or grant revenues, or from profit or fee on a federal procurement contract. A Project Awardee’s own source of funds may include corporate retained earnings, current or prospective Independent Research and Development (IR&D) funds or any other indirect cost pool allocation. New or concurrent (committed after Project Award) IR&D funds may be utilized as a cash contribution provided those funds identified by the Project Awardee will be spent on performance of the Statement of Work (SOW) of a Project Award or specific tasks identified within the SOW of a Project Award. Prior (committed before Project Award) IR&D funds will not be considered as part of the Project Awardee's cash or in- kind contributions, nor will prospective fees be considered on a Project Awardee’s cost sharing portion. Cash contributions include the funds a Project Awardee will spend for labor (including benefits and direct overhead), materials, new equipment (prorated if appropriate), awardees’ subaward efforts expended on the SOW of a Project Award, and restocking the parts and material consumed.
2.5 “Consortium” means the consortium established by the CMF and Government, comprised of a group of organizations collaborating to accomplish the objectives of the OTA, whose members represent industry, academia, for-profit organizations, non-profit organizations, and other entities.
2.6 “Consortium Management Firm” (CMF) means the organization funded by the Government to execute and administer the efforts under the OTA for this program between the Government and the CMF.
2.7 “Consortium Member” or “Consortium Members" means the individual organizations that are members of the RRPV and signatories to the Consortium Member Agreement.
2.8 “Consortium Member Agreement” (CMA) means the document signed by the Consortium members and CMF governing the rights and obligations of the Consortium Members as they relate to the Consortium and each other.
2 See 42 USC § 247d–7e
2.9 “Days” means calendar days unless otherwise noted.
2.10 “Effective Date” means the date of last signature.
2.11 “Field” means any work performed that relates to or falls within the scope of this Agreement or the BARDA mission.
2.12 “Government” means the United States of America herein represented by BARDA to include all BARDA personnel, both federal and non-federal.
2.13 “Government Fiscal Year” (“FY”) means the period commencing on October 1 and ending September 30 of the following calendar year.
2.14 “Government Purpose Rights” means the right by the Government to—
2.14.1 Use, modify, reproduce, release, perform, display, or disclose technical data within the Government without restriction; and
2.14.2 Release or disclose technical data outside the Government and authorize persons to whom release, or disclosure has been made to use, modify, reproduce, release, perform, display, or disclose that data for United States Government Purpose.
2.15 “Independent Research and Development (IR&D)” means a Project Awardee’s cost relative to projects falling within the four following areas: (a) basic research, (b) applied research, (c) development, and (d) system and other concept formulation studies. The term does not include the cost of effort sponsored by a grant or required in the performance of a contract. IR&D effort shall not include technical effort expended in developing and preparing technical data specifically to support submitting a bid and proposal.
2.16 “In-Kind Contribution” means the Project Awardees' non-financial resources expended by the Project Awardees to perform a Project Award such as wear-and-tear on in-place capital assets like machinery or the prorated value of space used for performance of the Project Award, and the reasonable fair market value (appropriately prorated) of equipment, materials, IP, and other property used in the performance of the SOW of the Project Award.
2.17 “Limited Rights” mean the rights to use, modify, reproduce, perform, display, or disclose data in whole or in part, within the Government. Government will ensure that disclosed information is safeguarded in accordance with the restrictions of this Agreement. The Government may not, without the prior written permission of the Project Awardee, release or disclose the data outside the Government, use the data for competitive procurement or manufacture, release or disclose the data for commercial purposes, or authorize the data to be used by another party. The Parties shall maintain the confidentiality of all data subject to or designated as falling within Limited Rights.
2.18 “Other Transaction Agreement” or “OTA” refers to the 42 USC § 247d–7e(c)(5) Other Transaction Agreement between the Government and, Advanced Technology International (ATI) for the Rapid Response Partnership Vehicle, Agreement No. 75A50123D00005.
2.19 “Other Transaction Agreements Officer” (OTAO) means the person identified by the Government in the OTA authorized to (1) obligate the Government under the OTA and any Project Award issued hereunder, and (2) modify the OTA and any Project Award issued hereunder.
2.20 “Other Transaction Technical Representative” (OTTR) means the person designated by BARDA to be responsible for managing the scientific and technical aspects of the OTA and assisting with agreement administration.
2.21 “Other Transaction Agreements Specialist” (OTAS) means technical representative identified by the Government to assist the OTAO on the OTA.
2.22 “Parties” means the RRPV member and the CMF collectively.
2.23 “Principal Investigator” mean the individual, provided by the Project Awardee, responsible for the conduct of the project.
2.24 “Project Approval Letter” (PAL) means the Project Awardee selection decision from BARDA to the CMF and authorizes the CMF to execute a Project Award. A PAL will include approved Statement of Work, award value, current funding, specific key Project Award considerations, and designated Project Award Representative (PAR). A PAL may be used for a modification to an existing Project Award.
2.25 “Project Awardee” means the RRPV consortium member that is issued a Project Award by the CMF.
2.26 “Project Award” means an agreement between the CMF and Project Awardee, as authorized by the Government, whose proposal is evaluated and selected by the Government for funding, establishing the scope of work, terms and conditions for the RRPV member’s performance and payment under the Government funded project. All Project Awards will be issued by the CMF. These awards may be of any appropriate type to include, but not limited to, fixed price, expenditure- based, cost share, milestone based, prize payments, etc.
2.27 “Project Award Representative” (PAR) means the individual designated by the Government on a per project basis to monitor all technical aspects and assist in agreement administration of a Project Award.
2.28 “Project OTAO” means the person identified by the Government in the OTA authorized to (1) obligate the Government under the respective Task Order and any Project Award issued thereunder, and (2) modify the subject Task Order and any Project Award issued thereunder. This may or may not be the same person as the OTAO for the OTA.
2.29 “Project Proposal” means a proposal submitted by the RRPV Member, through the CMF, to the Government for consideration for a Project Award by the Government Request for Project Proposal.
2.30 “Request for Project Proposal” means the Government’s request for proposals issued by the CMF to RRPV members, based on the focus areas or other mission requirements determined by the Government. Such request will include the technical, management, and cost factors as appropriate that will be used as the Government’s basis for award selection.
2.31 “Subject Invention” means any Invention conceived or first actually reduced to practice in the performance of work under a Project Award.
2.32 “Subject Matter Expert (“SME”)” means members of the Government RRPV team who provide technical insights into development activities being undertaken by Project Awardees to satisfy the terms of the OTA. BARDA enters into agreements with outside entities for the technical services of SMEs. As non-federal personnel, SMEs are subject to non-disclosure agreements as determined by each contract or agreement that they support.
2.33 “Task Order” or “OT Task Order” means an award issued under the OTA from the Government to the CMF which provides funding and scope for Project Awards.
2.34 “Unlimited Rights” means the rights of the Government to use, disclose, reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, in any manner and for any purpose, and to have or permit others to do so.
ARTICLE 3. TECHNICAL FOCUS AREAS
3.1 General. Under the Other Transaction Agreement, the CMF supports the Government in executing the dynamic needs of distinct and equally important technical focus areas. This approach is designed to enable targeted product development expertise and to ensure that, during a response event, sufficient dedicated resources are available to meet bold timelines, and avoid one technical focus area diverting resources from another. The initial focus areas are identified as follows:
3.1.1 Medical Technology (MedTech). MedTech refers to tools, equipment, and devices to diagnose and treat patients.
3.1.2 Vaccines and Therapeutics (Vx/Tx). Vx refers to a biological preparation that is used to stimulate the body's immune response against viruses or diseases. Tx refers to medical intervention intended to treat a health issue, viruses, or disease.
3.2 Revision of Focus Areas. The Focus Areas will be provided by the Government to the CMF, and the CMF will post the Focus Areas on its website for RRPV Consortium Members. The Government may revise or add Focus Areas at any time and will provide the RRPV CMF any such updates which will be posted on its website for RRPV members.
ARTICLE 4. REPORTS
4.1 Reports will be provided at the Project Award level.
4.2 The Government, at its discretion, will have access to and the right to examine records of the CMF per normal course of the Agreement. BARDA may periodically request information from the CMF, including information from Consortium Members and Project Awardees, that include technology, financial, and IP progress in order to track impact, performance, and progress. These updates and reports will be considered confidential and shared on a need-to-know basis within USG.
4.3 The Project Awardees shall submit documentation as prescribed by individual Project Awards. The documentation described below is the minimum reporting requirements that the CMF must include in each award:
4.3.1 Quarterly/Monthly3 and Annual Reports: One (1) copy shall be submitted or otherwise provided to the PAR and the CMF. The report will have two (2) major sections:
● Technical Status Report. The technical status report will detail technical progress to date and report on all problems, technical issues, major developments, and the status of external collaborations during the reporting period.
● Business Status Report. The business status report shall provide summarized details of the resource status of the Project Award, including the status of Project Awardee contributions. This report will include a quarterly accounting of current expenditures (or total amount of paid milestones, if FFP).
4.3.2 Final Report: One (1) copy shall be submitted or otherwise provided to the PAR and the CMF. Unless otherwise directed, any format may be used for the final report will have two (2) major sections:
● Final Technical Report. The Project Awardee shall submit or otherwise provide a Final Report making full disclosure of all major developments by Project Awardee upon completion of the Project Award or within sixty (60) calendar days of termination of the Project Award. With the approval of the PAR, reprints of published articles may be attached to the Final Report. One (1) copy shall be submitted or otherwise provided to the PAR.
● Final Business Status Report. The final business status report shall summarize details of the resource status of the Project Award, including the status of the contributions by all participants. This report will include a final accounting of incurred expenditures (or total amount of paid milestones, if FFP).
ARTICLE 5. FUNDING OBLIGATIONS AND PAYMENTS
5.1 Project Award Invoicing. Each Project Award shall identify the Payment Method for that project. The Project Awardee shall submit an invoice with the required level of detail, as well as the latest progress report to the CMF, who shall review and submit payment requests to the Project Award OTAO and PAR for the relevant work. After the PAR reviews the invoice and report, they will approve the invoice via signature and return to the CMF, allowing the CMF to issue payment to the Project Awardee.
5.2 Invoicing Instructions. Invoices may be submitted no more than monthly, unless Firm Fixed Price. The Project Awardee shall submit invoices and any necessary supporting documentation via email to RRPV-invoices@ati.org
5.3 Payment Method Types:
a. Fixed Price Milestone Payment Method: Payments shall be made in accordance with the Payable Milestone Schedule of each Project Award, provided the designated PAR has verified compliance with the Statement of Work and accomplishment of the stated effort. An acceptable invoice for fixed price milestone payments is one that:
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i. |
is addressed to the CMF and contains the CMF’s address: |
Advanced Technology International
315 Sigma Drive
Summerville, SC 29486
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ii. |
contains the date of invoice, invoice number, and the Base Agreement number and Project Award number (20XX-XXX #X); |
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iii. |
identifies the milestone number and description for any milestone(s) that are complete; and |
3 The decision to require progress reports at quarterly or monthly intervals will be determined by the PAR during RPP and project development phases.
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iv. |
lists the milestone cost negotiated and contained in the Project Award |
b. Expenditure-Based Milestone Payment Method (with not to exceed ceiling): Payment shall be made based on actual expenditures in completing milestones up to the total maximum amount allowable under the applicable Project Award, provided the designated PAR has verified compliance with the Statement of Work and accomplishment of the stated effort. Per (iii) below, a progress report identifying associated progress toward completion of each technical milestone is required with the invoice. An acceptable invoice for expenditure-based payment is one that:
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i. |
is addressed to the CMF and contains the CMF’s address: |
Advanced Technology International
315 Sigma Drive
Summerville, SC 29486
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ii. |
contains the date of invoice, invoice number, and the Base Agreement number and Project Award number (20XX-XXX #X); |
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iii. |
identifies any associated technical milestones and the progress toward completion of each technical milestone; |
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iv. |
includes a description of supplies and services, labor costs, subcontractor costs, material costs, travel costs, other direct costs, and extended totals; |
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v. |
indicates the current period and cumulative man-hours and costs incurred through the period indicated on the invoice; and |
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vi. |
contains the following certification statement: |
“I certify that the amounts invoiced are for costs incurred in accordance with the agreement, the work reflected has been performed, and prior payment has not been received.”
Authorized Signature ___________________________________
c. Expenditure-Based with Fixed Fee Milestone Payment Method (with not to exceed ceiling): Payment shall be made based on actual expenditures in completing milestones up to the total maximum amount allowable under the applicable Project Award, provided the designated PAR has verified compliance with the Statement of Work and accomplishment of the stated effort. Per (iii) below, a progress report identifying associated progress toward completion of each technical milestone is required with the invoice. An acceptable invoice for expenditure-based payment is one that:
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i. |
is addressed to the CMF and contains the CMF’s address: |
Advanced Technology International
315 Sigma Drive
Summerville, SC 29486
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ii. |
contains the date of invoice, invoice number, and the Base Agreement number and Project Award number (20XX-XXX #X); |
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iii. |
identifies any associated technical milestones and the progress toward completion of each technical milestone; |
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iv. |
includes a description of supplies and services, labor costs, subcontractor costs, material costs, travel costs, other direct costs, fixed fee and extended totals; |
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v. |
indicates the current period and cumulative man-hours and costs incurred through the period indicated on the invoice; and |
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vi. |
contains the following certification statement: |
“I certify that the amounts invoiced are for costs incurred in accordance with the agreement, the work reflected has been performed, and prior payment has not been received.”
Authorized Signature ___________________________________
d. Expenditure-Based, Cost Sharing Milestone Payment Method (with not to exceed ceiling): Payment shall be made based on actual costs incurred in completing milestones up to the maximum amount allowable under the applicable Project Award, provided the designated PAR has verified compliance with the Statement of Work and accomplishment of the stated effort. Per (iii) below, a progress report identifying associated the progress toward completion of each technical milestone is required with the invoice. An acceptable invoice for expenditure-based payment is one that:
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i. |
is addressed to the CMF and contains the CMF’s address: |
Advanced Technology International
315 Sigma Drive
Summerville, SC 29486
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ii. |
contains the date of invoice, invoice number, and the Base Agreement number and Project Award number (20XX-XXX #X); |
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iii. |
identifies any associated technical milestones and the progress toward completion of each technical milestone; |
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iv. |
includes a report of the cost share expended towards the accomplishment of the SOW tasks and/or milestones. This cost share report may be attached to the invoice if the Project Awardee’s practices make inclusion of such information on the invoice itself impractical. If the cost share report is separate from the invoice, it must be signed by an authorized representative. This cost share report must contain a breakout of the cost share by cost element similar to the level of detail required on the invoice and any in-kind contributions. The preferred method of reporting cost share is to provide an invoice for actual cost incurred with a value for the cost shared amount and the value to be reimbursed by the Government through the CMF; |
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v. |
includes a description of supplies and services, labor costs, subcontractor costs, material costs, travel costs, other direct costs, and extended totals; |
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vi. |
indicates the current period and cumulative man-hours and costs incurred through the period indicated on the invoice; and |
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vii. |
contains the following certification statement: |
“I certify that the amounts invoiced are for costs incurred in accordance with the agreement, the work reflected has been performed, and prior payment has not been received.”
Authorized Signature ___________________________________
5.4 Final Invoices. The Project Awardee’s final invoice (completion invoice) will be clearly indicated as such and shall indicate the cumulative amounts incurred and billed to completion, and a written certification of the total hours expended. Actual project costs incurred and cost share performance, if applicable, of each project shall be reported and reviewed in accordance with the Project Award reporting requirements.
5.5 Limitation of Funds. In no case shall the Government’s or the CMF’s or Consortium Members’ financial liability exceed the amount obligated by the Government or committed as a Cash Contribution or in-kind Contribution by the CMF or a Consortium Member under the Project Award. Nothing in this Article shall be construed to create the basis of a claim or suit where none would otherwise exist. In no event is the Government obligated to reimburse the recipient for expenditures in excess of the total funds allotted by the Government under a Project Award, regardless of any language to the contrary in any Termination clause herein or in any Project Award.
5.6 Payment Terms. Payment terms are NET 30 days after CMF’s receipt of an acceptable invoice. An acceptable invoice is one that meets the conditions described in Section 5.3 Payment Method Types and approved by the PAR.
ARTICLE 6. ADMINISTRATION
6.1 Financial Records and Audit Access. The costs incurred under any expenditure-based Project Award shall be those costs that are reasonable and prudent. Actual costs under expenditure-based Project Awards, including those direct costs associated with the research project as well as any indirect costs, are reimbursable to the extent they have a significant relationship to providing the goods or service under the Project Award.
The Project Awardee shall ensure that, for each Project Award, the Project Awardee’s relevant financial records are available and subject to examination or audit on behalf of the Government for a period not to exceed three (3) years after final payment of the Project Award.
Unless otherwise notified by the OTAO, these records are also subject to examination or audit by the Government’s General Accountability Office (GAO). Such audit, examination, or access shall be performed during business hours on business days upon prior written notice and shall be subject to the security requirements of the audited Party. Any audit required during the course of this Agreement may be conducted by the Government using Government auditors or, at the request of the Project Awardee, by the Project Awardee’s external CPA accounting firm at the expense of the Project Awardee. The terms of this paragraph shall be included in all sub-agreements to the Project Award.
6.2 Accounting System. The Project Awardee shall have and maintain an established accounting system, which complies with Generally Accepted Accounting Principles, or comparable approved standards, and shall ensure that appropriate arrangements have been made for receiving, distributing, and accounting for federal funds. An adequate accounting system for an expenditure-based Project Award is normally accomplished through a job order cost accounting system, whereby the books and records segregate direct costs by agreement and includes an established allocation method for the equitable allocation of indirect costs among agreements/contracts.
6.3 Administrative Matters. Administrative matters under this Agreement shall be referred to the following representatives:
RRPV Member Organization:
Mark Reynolds
Chief Financial Officer
GeoVax, Inc.
1900 Lake Park Drive, Suite 380
Smyrna, GA 30080
678-384-7220
mreynolds@geovax.com
RRPV Consortium Management Firm:
Rebecca Harmon
Sr. Contracts Manager
Advanced Technology International
315 Sigma Drive
Summerville, SC 29486
(843) 760-3358
RRPV-contracts@ati.org
6.4 Technical Matters. Technical matters under this Agreement shall be referred to the following representative:
RRPV Member Organization:
Kelly T. McKee, Jr., MD, MPH
Chief Medical Officer
GeoVax, Inc.
1900 Lake Park Drive, Suite 380
Smyrna, GA 30080
678-384-7220
kmckee@geovax.com
RRPV Consortium Management Firm:
Wendy Rehman
Program Manager
Advanced Technology International
315 Sigma Drive
Summerville, SC 29486
(843) 760-3362
RRPV-deliverables@ati.org
A Project Award Representative (PAR) will be identified on each Project Award.
6.5 System for Award Management (SAM). The RRPV member will be required to obtain a Unique Entity Identifier (UEI) from SAM.gov prior to award of a Project Award. A full SAM.gov registration is not required. See www.sam.gov for more information.
6.6 Invoicing. All invoice submissions are to be in accordance with Article 5.
6.7 Management of Project Awards. Performance of the work on Project Awards is subject to the technical oversight of the PAR designated in the Project Award.
6.7.1 For the purposes of this clause, technical oversight includes the following:
a. Direction to the Project Awardee, which shifts work emphasis between work areas or tasks, requires pursuit of certain lines of inquiry, fills in details or otherwise serves to accomplish the objectives described in the statement of work;
b. Guidelines to the Project Awardee that assists in the interpretation of drawings, specifications or technical portions of work description.
c. Review and, where required by the Project Award, approval of technical reports, drawings, specifications, or technical information to be delivered by the Project Awardee under the Project Award.
The PAR shall monitor the Project Awardee’s performance with respect to compliance with the technical requirements of the Project Award.
6.7.2 Technical direction must be within the general scope of work stated in the Project Award. Technical direction may not be used to:
a. Assign additional work under the Project Award;
b. Increase or decrease the estimated Project Award cost, fee (if any), or the time required for the project period of performance;
c. Change any of the terms, conditions or specifications of the Project Award; or
d. Accept non-conforming work.
6.7.3 As such, no verbal or written request, notice, authorization, direction or order received by the Project Awardee shall be binding upon the CMF or Government, or serve as the basis for a change in the Project Award cost or any other provision of the Project Award, unless issued (or confirmed) in writing by the CMF.
6.7.4 The Project Awardee shall immediately notify the Project Award CMF Contractual Representative whenever a verbal or written change notification has been received from anyone other than the CMF, which would affect any of the terms, conditions, cost, schedules, etc. of the Project Award, and the Project Awardee is not to perform any work or make any changes in response to any such notification or make any claim on the CMF or Government, unless the CMF directs the Project Awardee, in writing, to implement such change notification.
6.8 Modifications. The only method by which this Agreement or Project Award may be modified is by a formal, written modification signed by the CMF, and, if necessary, additionally by the Project Awardee.
6.8.1 Bilateral Modifications. Project Awardees may propose modifications to any Project Award in which they are involved, including justifications to support any proposed changes, by submitting a written request through the CMF to the Government. The modification request shall detail the technical, chronological, and financial impact of the proposed change to the Project Award.
6.8.2 Unilateral Modifications. The CMF may unilaterally issue minor or administrative modifications, which do not materially change the obligations of the CMF or Project Awardee, such as incremental funding increases , or changes to personnel identified in the Agreement or Project Award. Unilateral modifications will be signed by only the CMF.
6.8.3 Modification Communications. No other communications, whether oral or in writing, that purport to change this Agreement or a Project Award are valid.
6.9 Pre-Award Costs. Pre-Award costs supporting a Project Award are impermissible unless a written approval is authorized by the OTAO, through the CMF, or contained in the RPP.
Project Subaward Approval. Subawards that are proposed and agreed to during negotiations for a Project Award are considered as having OTAO approval. Modifications to approved subawards and/or new subawards, under a Project Award that will significantly impact the teaming arrangement and/or technical approach proposed and accepted require OTAO, through the CMF, approval prior to being executed.
6.10 Title and Disposition of Property. In this paragraph, “property” means any tangible personal property other than consumable property, which is not consumed during the execution of effort under a Project Award (e.g., equipment).
6.10.1 Title to Property, General. Title to property under Project Awards shall be determined per the below guidance.
6.10.2 Title to Property: Fixed Price Project Awards. Project Awardee retains title to all property acquired as necessary to execute the work under the Project Award, unless otherwise dictated in the Project Award.
6.10.3 Title to Property: Expenditure-Based (and other) Project Awards. Items of property with an acquisition value equal to or less than $10,000 vest with the Project Awardee upon acquisition. For items greater than $10,000, the Project Awardee must obtain approval from the OTAO, through the CMF, prior to purchasing property using Government funds in order to retain title. Property listed in the cost proposal is considered as having received OTAO approval. For those items of real property or nonexpendable personal property having a unit acquisition cost of $10,000 or more, which will be acquired with Government funds received through the CMF, the Government reserves the right to transfer the title to the Federal Government or to a third Party named by the Government. If a Project Award includes the use of real property or equipment that is purchased with non-federal funds or that is donated by a third party to meet a portion of any required cost sharing or matching, the Government will have a financial interest in the property equal to the Federal funding in the project and such property shall be subject to this Article.
6.10.4 Disposition of Property. At the completion of Project Awards containing property in which title does not vest with the Project Awardee, property shall be disposed of in the following manner:
6.10.4.1 Purchased by the Project Awardee at an agreed-upon price, the price to represent fair market value, with the proceeds of the sale being returned as a credit to the Government; or,
6.10.4.2 Transferred to a Government research facility with title and ownership being transferred to the Government or to an eligible third party; or
6.10.4.3 Any other Government approved disposition procedures as approved by the Project OTAO, through the CMF. The Government shall provide disposition procedures within 120 days of being requested by the CMF to provide disposition.
ARTICLE 7. PROPRIETARY INFORMATION
7.1 Definitions for Article 7.
7.1.1. “Disclosing Party” means the CMF, a Consortium Member, Project Awardee, or the Government which discloses Proprietary Information as contemplated by the subsequent paragraphs.
7.1.2. “Receiving Party” means the CMF, a Consortium Member, Project Awardee, or the Government which receives Proprietary Information disclosed by a Disclosing Party.
7.1.3. “Proprietary Information” means information and materials of a Disclosing Party which are designated as Proprietary Information or as a Trade Secret or subject to export control in writing by such Disclosing Party, whether by letter or by use of an appropriate stamp or legend, prior to or at the same time any such information or materials are disclosed by such Disclosing Party to the Receiving Party. Notwithstanding the foregoing, materials and other information that are orally, visually, or electronically disclosed by a Disclosing Party, or are disclosed in writing without an appropriate letter, stamp, or legend, shall constitute Proprietary Information or a Trade Secret or be subject to export control if such Disclosing Party, within thirty (30) calendar days after such disclosure, delivers to the Receiving Party a written document or documents describing the material or information and indicating that it is proprietary or a Trade Secret or subject to export control. Any disclosure of information by the Receiving Party prior to receipt of such notice shall not constitute a breach by the Receiving Party of its obligations under this Article.
7.1.4. “Trade Secret” means all forms and types of financial, business, scientific, technical, economic, or engineering information, including patterns, plans, compilations, program devices, formulas, designs, prototypes, methods, techniques, processes, procedures, programs, or codes, whether tangible or intangible, and whether or how stored, compiled, or memorialized physically, electronically, graphically, photographically, or in writing if,
7.1.4.1. The owner thereof has taken reasonable measures to keep such information secret; and
7.1.4.2. The information derives independent economic value, actual or potential, from not being generally known to, and not being readily ascertainable through proper means by, the public.
7.2 Exchange of Information. Consortium Members may from time to time disclose Trade Secrets to the Government or to other Consortium Member(s) in connection with the Projects Awards. Neither the Government, nor the CMF, nor any Consortium Member, nor any Project Awardee, shall be obligated to transfer Proprietary Information or Trade Secrets independently developed unless a condition of the Project Award.
7.3 Confidentiality and Authorized Disclosure. The Receiving Party agrees, to the extent permitted by law, that Proprietary Information and Trade Secrets shall remain the property of the Disclosing Party (no one shall disclose such information unless they have the right to do so), and that, unless otherwise agreed to by the Disclosing Party, Proprietary Information and Trade Secrets shall not be disclosed, divulged, or otherwise communicated by the Receiving Party to third parties (including without limitation, other Consortium Members) or used by the Receiving Party for any purposes other than in connection with the Project Awards and the licenses granted via this Agreement; provided that the terms “Proprietary Information “and “Trade Secrets” shall exclude materials or information that:
7.3.1 Are received or become available without restriction to the Receiving Party under separate agreement;
7.3.2 Are not identified with a suitable notice or legend prescribed under this Agreement;
7.3.3 Are in possession of the Receiving Party at the time of disclosure thereof as demonstrated by prior written records;
7.3.4 Are or later become part of the public domain through no fault of the Receiving Party;
7.3.5 Are received by the Receiving Party from a third Party having no obligation of confidentiality to the Disclosing Party that made the disclosure;
7.3.6 Are developed independently by the Receiving Party without use of Proprietary Information or Trade Secrets as evidenced by written records;
7.3.7 Are required by law or regulation to be disclosed; provided, however, that the Receiving Party has provided written notice to the Disclosing Party promptly so as to enable such Disclosing Party to seek a protective order or otherwise prevent disclosure of such information.
7.4 Term. The obligations of the Receiving Party under this Article shall continue for a period of two (2) years after the expiration or termination of this Agreement.
7.5 Flow down. The Project Awardee shall include this Article, suitably modified, to identify all parties, in all subawards. This Article shall, in turn, be included in all other forms of lower tier awards, regardless of tier. The Government will be a third party in interest for purposes of this Article in any agreement where flow down of rights and obligations is required.
ARTICLE 8. RIGHTS IN DATA
8.1 General. The Data Rights in this Article are specifically tailored for this Agreement to address respective rights of the Government and the Project Awardees to be included in Project Award Agreements to such Data as is owned, developed, to be developed or used by an actual or prospective Project Awardee (1) as identified in a Project Proposal submitted to the Government through the CMF in response to a Request for Proposals, and (2) when such proposal is selected by the Government for funded performance and the Project Award is issued by the CMF to that Project Awardee for performance of such Project Award.
8.2 Allocation of Principal Rights.
8.2.1 The Government shall have Unlimited Rights for use in the Field in:
8.2.1.1 Preexisting data funded by the Government. For clarity, Government rights in any preexisting data produced by Project Awardee and funded by the Government under a separate agreement shall be governed by such separate agreement, and this Agreement shall not alter any Government rights in such data produced outside of this Agreement;
8.2.1.2 Data first produced in the performance of this Agreement exclusively with Government funds;
8.2.1.3 Form, fit, and function data delivered under this Agreement; and
8.2.1.4 Data delivered under this Agreement (except for restricted computer software) that constitute manuals or instructional and training material for installation, operation, or routine maintenance and repair of items, components, or processes delivered or furnished for use under this Agreement.
8.2.2 The Government shall have Government Purpose Rights to all data produced in performance of this Agreement that was funded jointly by both parties under a cost sharing arrangement. The Government also reserves the right to negotiate for Government Purpose Rights for data described in 8.2.1.
8.2.3 The Government shall have Limited Rights to (a) all data, other than restricted computer software, that embody trade secrets or are commercial or financial and confidential or privileged, that pertains to items, components, or processes developed at private expense in the performance of this Agreement, and (b) data contained in a disclosure of a Subject Invention provided to the agency prior to the filing of a patent application.
8.3 Parties' Obligations Regarding Data.
8.3.1 The Project Awardee agrees to retain and maintain in good condition all data necessary to achieve Practical Application of any Subject Invention in accordance with the Project Awardee’s established record retention practices. In the event of exercise of the Compulsory Licensing Rights as set forth under this Agreement, Project Awardee agrees, upon written request from the Government, to deliver, as mutually agreed between the Parties, all existing Data necessary to achieve Practical Application of the relevant Subject Invention within sixty (60) calendar days from the date of the written request. Unless otherwise negotiated, the Government shall obtain Government Purpose Rights to this delivered Data, except for Data subject to Limited Rights as identified herein.
8.3.2 The Project Awardee’s right to use Data includes the right under Project Awardee’s established business policies to make public research data (especially human research data) by publication in the scientific literature, by making trial protocols, trial results summaries, and clinical studies reports publicly available, and by making trial patient-level data available for third-party analysis. Project Awardee’s publication of Data disclosing any Subject Invention shall trigger Project Awardee’s obligation to file an application for a patent to such Subject Invention under this Agreement.
8.4 Marking of Data.
8.4.1 The Project Awardee will mark any Data delivered under a Project Award with Limited Rights with the following legend:
“LIMITED RIGHTS”
These data are submitted with limited rights under Agreement No. 75A50123D00005. These data may be reproduced and used by the Government with the express limitation that they will not, without written permission of the CMF, be used for purposes of manufacture nor disclosed outside the Government; except that the Government may disclose these data outside the Government for purposes defined in the Project Award, if any, provided that the Government makes such disclosure subject to prohibition against further use and disclosure.
8.4.2 Identification and Disposition of Data. The Project Awardee shall keep copies of all Data required by the FDA relevant to the Project Award for the time specified by the FDA. In addition, the Project Awardee shall provide regulatory data to the OTTR and OTAS (through the CMF) in accordance with the deliverable schedules in the Project Award’s Statement of Work. The Government reserves the right to review any other data determined by the Government to be relevant to this Agreement. The Government further acknowledges that Project Awardee holds the commercialization rights for all products developed under the Project Award and will be responsible for their registration with the FDA.
8.5 Negotiating Other Rights. Notwithstanding the paragraphs in this Article, differing rights in Data may be negotiated among the Parties to each individual Project Award on a case-by-case basis as memorialized in the Project Award.
8.6 Survival Rights. Provisions of this Article will survive termination of this Agreement.
8.7 Copyright
8.7.1 The Project Awardee, reserves the right to protect by copyright original works developed under this Agreement. All such copyrights will be in the name of the individual Project Awardee. The Project Awardee hereby grants to the U.S. Government a non-exclusive, non-transferable, royalty-free, fully paid-up license to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, for governmental purposes, any copyrighted materials developed under this Agreement, and to authorize others to do so.
8.7.2 In the event Data is exchanged with a notice indicating that the Data is protected under copyright as a published, copyrighted work and it is also indicated on the Data that such Data existed prior to, or was produced outside of this Agreement, the Party receiving the Data and others acting on its behalf may reproduce, distribute, and prepare derivative works for the sole purpose of carrying out that Party’s responsibilities under this Agreement with the written permission of the Copyright holder.
8.7.3 Data that existed or was produced outside of this Agreement and is unpublished - having only been provided under licensing agreement with restrictions on its use and disclosure - and is provided under this Agreement shall be marked as unpublished copyright in addition to the appropriate license rights legend restricting its use and treated in accordance with such license rights legend markings restricting its use.
8.7.4 The Project Awardee is responsible for affixing appropriate markings indicating the rights of the Government on all Data delivered under this Agreement.
8.7.5 The Government agrees not to remove any copyright notices placed on Data and to include such notices on all reproductions of the Data.
ARTICLE 9. INVENTIONS
9.1 Allocation of Principal Rights and Obligations.
9.1.1 Ownership. The Project Awardee shall retain ownership of each Subject Invention throughout the world, unless (i) Project Awardee shall have notified the OTAO, through the CMF, that Project Awardee does not intend to retain ownership of such Subject Invention in accordance with of this Article, (ii) Project Awardee fails to disclose such Subject Invention to the OTAO, through the CMF, in accordance with terms defined herein, or (iii) Project Awardee fails to file a patent application for such Subject Invention in accordance with the terms of this Agreement, in which case ownership shall vest with the Government.
9.1.2 License to Government for Subject Inventions to Which Project Awardee Retains Ownership. With respect to any Subject Invention made under a Project Award in which the Project Awardee retains title, the Government shall have a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced on behalf of the United States the Subject Invention throughout the world. For clarity, this license does not include the right to use or allow others to use the Subject Invention for commercial purposes.
9.2 Project Awardee’s Obligations.
9.2.1 The Project Awardee shall disclose in writing each Subject Invention to the OTAO, through the CMF, within one (1) year after the inventor discloses it in writing to Recipient personnel responsible for patent matters. The disclosure shall identify the inventor(s) and the Project Award under which the Subject Invention was made. It shall be sufficiently complete in technical detail to convey a clear understanding of the Subject Invention. The parties agree that the information contained in the disclosure shall qualify as limited rights data as defined under this Agreement and is not subject to further disclosure without mutual agreement. Parties agree that such disclosure remains confidential pending filing of a patent application as detailed below.
9.2.2 The Project Awardee shall elect in writing whether or not to retain ownership of any Subject Invention by notifying the OTAO, through the CMF, within two (2) years of disclosure to the agency. In the event that the Project Awardee’s publication or use of the data has initiated the one-year statutory period during which valid patent protection can be obtained in the United States, the period for election of title may be shortened by the agency to a date that is no more than 60 calendar days prior to the end of the statutory period.
9.2.3 The Project Awardee shall file either a provisional or a non-provisional patent application on an elected Subject Invention within one year after election. If the Project Awardee files a provisional application, it shall file a non-provisional application within 12 months of the filing of the provisional application. The Project Awardee shall file patent applications in additional countries (or international patent offices within either 12 months of the first filed patent application or 6 months from the date permission is granted by the Commissioner of Patents to file foreign patent applications, where such filing has been prohibited by a Secrecy Order.
9.2.4 The Project Awardee may request extensions of time for disclosure, election, or filing under this Article.
9.3 Conditions When the Government May Obtain Title. Upon the Government’s written request, the Project Awardee shall convey title to any Subject Invention to the Government under any of the following conditions:
9.3.1 If the Project Awardee fails to disclose or elects not to retain title to the Subject Invention within the times specified under this Article.
9.3.2 In those countries in which the Project Awardee fails to file patent applications within the times specified in this Article; provided, that if Project Awardee has filed a patent application in a country after the times specified in this Article, but prior to its receipt of the written request by the Government, Project Awardee shall continue to retain title in that country; or
9.3.3 In any country in which the Project Awardee decides not to continue the prosecution of any application for, to pay the maintenance fees on, or defend in reexamination or opposition proceedings on, a patent on a Subject Invention.
9.3.4 License to Project Awardee for Subject Inventions to which the Project Awardee Does Not Elect to Retain Ownership.
9.3.4.1 In the event that the Project Awardee does not elect to retain ownership in a Subject Invention pursuant to this Article, the Project Awardee shall retain a nonexclusive royalty-free license throughout the world in such Subject Invention to which the Government obtains title pursuant to 9.3 of this Article, unless the Project Awardee fails to disclose the invention within the times specified in this Article. The Project Awardee’s license extends to any domestic subsidiaries and affiliates within the corporate structure of which the Project Awardee is a part and includes the right to grant sublicenses to the extent the Project Awardee was legally obligated to do so at award of the Project Award. The license is transferable only with the written approval of the Government, except when transferred to the successor of that part of the Recipient’s business to which the invention pertains. The Government approval for license transfer shall not be unreasonably withheld.
9.3.4.2 The Project Awardee’s license may be revoked or modified by the Government to the extent necessary to achieve expeditious practical application of the Subject Invention in a particular country in accordance with the procedures outlined under this Agreement.
9.3.5 Third Party Application.
9.3.5.1 In response to a third party’s proper application for an exclusive license, the Project Awardee’s domestic license may be revoked or modified to the extent necessary to achieve expeditious practical application of the Subject Invention. The application shall be submitted in accordance with the applicable provisions in 37 CFR part 404 and agency licensing regulations. The Project Awardee’s license will not be revoked in that field of use or the geographical areas in which the Project Awardee has achieved practical application and continues to make the benefits of the Subject Invention reasonably accessible to the public. The license in any foreign country may be revoked or modified to the extent the Project Awardee, its licensees, or its domestic subsidiaries or affiliates have failed to achieve practical application in that country.
9.3.5.2 Revocation or modification of the Project Awardee’s minimum rights. Before revoking or modifying the Project Awardee’s license in accordance this Article, the OTAO, through the CMF, shall furnish the Project Awardee a written notice of intention to revoke or modify the license. The Government shall allow the Project Awardee at least 30 days (or another time as may be authorized for good cause by the OTAO) after the notice to show cause why the license should not be revoked or modified. The Project Awardee has the right to appeal, in accordance with applicable regulations in 37 CFR part 404 and agency licensing regulations, any decisions concerning the revocation or modification.
9.3.6 License to the Project Awardee for Subject Inventions to Which the Project Awardee Has Elected to Retain Ownership but Does Not File a Patent Application or does Not Prosecute a Patent Application.
9.3.6.1 In the event that Project Awardee has elected to retain ownership of a Subject Invention but subsequently elects not to file a patent application for the Subject Invention or elects not to prosecute a patent application for the Subject Invention, the Project Awardee shall retain a fully paid up, sub- licensable, nonexclusive, royalty-free license throughout the world in each Subject Invention to which the Government obtains title, except if the Project Awardee fails to disclose the Subject Invention within the times specified in this Article. The Project Awardee’s license extends to the Project Awardee’s subsidiaries and Affiliates, if any, within the corporate structure of which the Project Awardee is a party and includes the right to grant licenses of the same scope to the extent that the Project Awardee was legally obligated or permitted to do so at the time the Project Award was executed. The license is otherwise transferable only with the approval of the Government, except when transferred to an Affiliate or successor of that part of the Project Awardee’s business to which the Subject Invention pertains. The Government approval for license transfer shall not be unreasonably withheld.
9.3.6.2 The Project Awardee’s license under this Paragraph may be revoked or modified by the Government to the extent necessary to achieve expeditious Practical Application of the Subject Invention pursuant to an application for an exclusive or nonexclusive license submitted consistent with appropriate provisions at 37 CFR Part 404. The Project Awardee’s license shall not be revoked in that field of use or the geographical areas in which the Project Awardee has achieved Practical Application of the Subject Invention and continues to make the benefits of the Subject Invention accessible to the public.
9.3.6.3 Before revocation or modification of the Project Awardee’s license under this Paragraph, the Government shall furnish the Project Awardee with a written notice of its intention to revoke or modify the license, and the Project Awardee shall be allowed thirty (30) calendar days (or such other time as may be authorized for good cause shown) after the notice to show cause why the license should not be revoked or modified.
9.4 Actions to Protect the Government’s Interests. The Project Awardee agrees to execute or to have executed and promptly deliver to the Government all instruments necessary to (i) establish or confirm the rights the Government has throughout the world in those Subject Inventions to which the Project Awardee elects to retain title and (ii) convey title to the Government when requested pursuant to this Article and to enable the Government to obtain patent protection throughout the world in that Subject Invention.
9.4.1 The Project Awardee shall require, by written agreement, its employees, other than clerical and non-technical employees, to disclose promptly in writing to personnel identified as responsible for the administration of patent matters and in a format suggested by the Project Awardee, each Subject Invention made under this Agreement so the Project Awardee can comply with the disclosure provisions of this Article. The Project Awardee shall instruct employees, through employee agreements or other suitable educational programs, on the importance of reporting inventions in sufficient time to permit the filing of patent applications prior to U.S. or foreign statutory bars. The Project Awardee shall also instruct all employees, in accordance with its regular business practices, on the need to maintain confidentiality of any information covered by the disclosure under this Article.
9.4.2 The Project Awardee shall notify the Government of any decisions not to continue the prosecution of a patent application for a Subject Invention, pay maintenance fees, or defend in a reexamination or opposition proceedings on a patent of a Subject Invention, in any country, not less than sixty (60) calendar days before the expiration of the response period required by the relevant patent office.
9.4.3 The Project Awardee shall include, within the specification of any United States patent application and any patent issuing thereon covering a Subject Invention, the following statement: “This invention was made with Government support under Agreement 75A50123D00005 awarded by The Department of Health and Human Services. The Government has certain rights in the invention.”
9.5 Reporting on Utilization of Subject Inventions.
9.5.1 Upon Government request, the Project Awardee agrees to submit, during the Term of the Project Award, an annual report on the utilization of a Subject Invention or on efforts at obtaining such utilization that is being made by the Project Awardee or its licensees or assignees. Such reports shall include information regarding the status of development, date of first commercial sale or use, and such other data and information as the agency may reasonably specify. The Project Awardee also agrees to provide additional reports as may be requested by the Government in connection with any compulsory licensing proceedings undertaken by the Government in accordance with this Article. The Government agrees it shall not disclose such information to persons outside of the Government, and non-federal Government personnel, and the CMF, without permission of the Project Awardee.
9.5.2 All required reports shall be submitted to the OTAS, OTAO (through the CMF), and PAR.
9.6 Compulsory Licensing Rights. The Project Awardee agrees that, with respect to any Subject Invention in which it has retained title, the Government has the right to require the Project Awardee through the CMF, an assignee, or exclusive licensee of a Subject Invention to grant a non-exclusive license to a responsible applicant or applicants, upon terms that are reasonable under the circumstances, and if the Project Awardee refuses such a request, the Government has the right to grant such a license within the Field itself only if the Government determines that:
9.6.1 Such action is necessary because the Project Awardee or assignee has not taken effective steps, consistent with the intent of this Agreement, to achieve practical application of the subject invention; or
9.6.2 Such action is necessary to alleviate health or safety needs, which are not reasonably satisfied by the Project Awardee, assignee, or their licensees; or
9.6.3 Such action is necessary to meet requirements for public use specified by Federal regulations and such requirements are not reasonably satisfied by the CMF, assignee, or licensees; or
9.6.4 Such action is necessary because the agreement required by 35 U.S. Code § 204 has not been obtained or waived or because a licensee of the exclusive right to use or sell any subject invention in the United States is in breach of its agreement obtained pursuant to section 35 U.S. Code § 204.
9.7 Differing Patent Rights. Notwithstanding the paragraphs of this Article, differing patent rights may be negotiated among the Parties to each individual Project Award on a case-by-case basis as memorialized in the Project Award.
ARTICLE 10. FOREIGN ACCESS TO TECHNOLOGY
10.1 Foreign Access to Technology. The Parties agree that research findings and technology developments arising under this Agreement may constitute a significant enhancement to the national security, and to the economic vitality of the United States. Accordingly, access to important technology developments under this Agreement by foreign firms or institutions must be carefully controlled. The controls contemplated in this Article are in addition to, and are not intended to change or supersede, existing law or regulation.
10.2 Restrictions on Sale or Transfer of Technology to Foreign Firms or Institutions. In order to promote the national security and economic interests of the United States and to effectuate the policies that underlie the regulations cited above, the procedures stated in this Article below shall apply to any transfer of technology. For purposes of this paragraph, a transfer includes a sale of the company, and sales or licensing of Technology.
10.2.1 Transfers do not include:
10.2.1.1 Sales of products or components;
10.2.1.2 Licenses of software or documentation related to sales of products or components;
10.2.1.3 Transfer to foreign subsidiaries for purposes related to this Agreement; or
10.2.1.4 Transfer which provides access to Technology to a Foreign Firm or Institution which is an approved source of supply or source for the conduct of research under this Agreement provided that such transfer shall be limited to that necessary to allow the firm or institution to perform its approved role under this Agreement.
10.2.2 The Project Awardee shall provide timely notice to HHS of any proposed transfers from the Project Awardee of Technology developed under this Agreement to Foreign Firms or Institutions. If HHS determines that the transfer may have adverse consequences to the national security interests of the United States, HHS shall jointly endeavor to find alternatives to the proposed transfer which obviate or mitigate potential adverse consequences of the transfer, but which provide substantially equivalent benefits.
10.2.3 In any event, Project Awardee shall provide written notice to the CMF of any proposed transfer from a Project Awardee to a foreign firm or institution at least sixty (60) calendar days prior to the proposed date of transfer. Such notice shall cite this Article and shall state specifically what is to be transferred and the general terms of the transfer. Within thirty (30) calendar days of receipt of written notification, the OTAO shall advise CMF whether it consents to the proposed transfer. No transfer shall take place until a decision is rendered.
10.2.4 In the event a transfer of Technology to Foreign Firms or Institutions which is NOT approved by HHS takes place, Project Awardee shall (a) refund to HHS funds paid pursuant to the Project Agreement for the development of the Technology and (b) the Government shall have a non-exclusive, nontransferable, irrevocable, paid-up license to practice or have practiced on behalf of the United States the Technology throughout the world for Government and any and all other purposes, particularly to effectuate the intent of the Project Agreement. Upon request of the Government, the Project Awardee shall provide written confirmation of such licenses.
ARTICLE 11. PUBLICATION AND PUBLICITY
11.1 Review of Press Releases. All Parties agree to accurately and factually represent the work conducted under this Agreement in all press releases. Misrepresenting results or releasing information that is injurious to the integrity of a Party may be construed as improper conduct. Press releases shall be defined as the public release of information via any medium, excluding peer- reviewed scientific publications. The Project Awardee agrees to provide the Government and the CMF with an advance copy of any press release related to this Agreement for review and approval not less than ten (10) business days prior to the issuance of the press release. The PAR or OTAO will provide approval. The review time may be expedited for press releases issued to address safety concerns or issues of significant internal importance to the Project Awardee, when possible. Federal funds received through support shall be acknowledged in all such press releases substantially as follows:
“This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50123D00005.”
11.2 Publication of Data. No Data or other information obtained, delivered, or produced under this Agreement or Project Award shall be released or publicized without concurrence from the Government. For purposes of this Agreement, “publication” is defined as an issue of printed material offered for distribution or any communication or oral presentation of information, including any manuscript or scientific meeting abstract. Any publication containing Data generated under this Agreement, or Project Award, must be submitted to the CMF and the Government for review and comment no less than thirty (30) calendar days before submission of any manuscript for public presentation or publication, and no less than fifteen (15) calendar days before submission of any abstract for public presentation or publication. The Government’s support shall be acknowledged in all such publications substantially as follows:
“This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50123D00005.”
ARTICLE 12. TERM OF AGREEMENT AND TERMINATION
12.1 Term of the Agreement. The Agreement is effective upon the Effective Date, which is the date of last signature, to September 20, 2033. The term of each project will be as stated in each individual Project Award. The terms of individual Project Awards may extend beyond the term of this Agreement.
12.2 Termination of This Agreement by Mutual Agreement. This Agreement shall terminate by written agreement of the CMF and the Project Awardee or upon completion of all Project Awards. Rights and obligations with respect to proprietary information and/or specific intellectual property agreements between or amongst the Government and the CMF and the Project Awardee shall survive any such mutual termination agreement unless otherwise agreed to in writing.
ARTICLE 13. CONSORTIUM MEMBERSHIP TERMS AND PROJECT AWARDS
13.1 Membership.
13.1.1 Addition of Members to the Consortium. The consortium shall operate as an open model with a continuous membership application and approval process. Membership applications will be received by the CMF and subsequently submitted to the Government who will make the final decision if applicants will be permitted to join the consortium. OTAO will provide Government approval.
13.1.2 Minimum Requirements to Join the Consortium.
13.1.2.1 Organization shall possess a technology relevant to the RRPV mission of advancing medical countermeasures.
13.1.2.2 Organization shall not be suspended or barred from conducting business with or receiving funds from the USG.
13.1.3 Withdrawal of Consortium Members. Any consortium member may voluntarily withdraw from the Consortium at any time by providing notice to the CMF of this decision at least 30 days in advance. The Government reserves the right to unilaterally remove any member from the consortium if it determines their removal to be in the best of interest of the Government and provides the member with 10 days’ notice of its decision. The CMF will immediately notify the Government of any member’s withdrawal from the consortium.
13.1.4 Rights of a Consortium Member Following Withdrawal. Except for rights and obligations specified at the individual Project Award level, such as specific property or IP rights, from and after the effective withdrawal date, the former consortium member shall cease to have any rights or obligations as a consortium member under the RRPV. In the event of a withdrawal, in which the consortium member is currently executing any Project Award, the consortium member’s obligation shall continue in accordance with the previously agreed-to schedule until its completion or the Government and consortium member come to an agreement to terminate the task, whichever is first.
13.2 Term. The term of the Project Awards will be as stated in the terms and conditions of each individual Project Award.
13.3 Stop Work
13.3.1 As directed by the OTAO, the CMF may, at any time, by written order to the Project Awardee, require the Project Awardee to stop all, or any part, of the work called for under any Project Award for a period directed by the OTAO after the written order is delivered to the Project Awardee. The order shall be specifically identified as a stop-work order issued under this Article. Upon receipt of the order, the Project Awardee shall immediately comply with its terms and take all reasonable steps to minimize the incurrence of costs allocable to the work covered by the order during the period of work stoppage. Within a period of 90 days after a stop-work is delivered to the Project Awardee, or within any extension of that period to which the Parties shall have agreed, the Government shall direct the RRPV CMF to either:
13.3.1.1 Cancel the stop-work order; or
13.3.1.2 Terminate the work covered by the Project Award.
13.3.2 If a stop work order issued under this Article is canceled, the Project Awardee shall resume work. The Government through the RRPV CMF shall make an equitable adjustment in the delivery schedule or Project Award estimated cost/price, or both, and the Government’s share of the Project Award shall be modified, in writing, accordingly, if—
13.3.2.1 The stop-work order results in an increase in the time required for, or in the Project Awardee's cost properly allocable to, the performance of any part of the Project Award; and
13.3.2.2 The Project Awardee asserts its right to the adjustment within 30 days after the end of the period of work stoppage; provided that, if the Government decides the facts justify the action, the Government through the CMF may receive and act upon a proposal submitted at any time before final payment under the Project Award.
13.3.3 If a stop work order is not canceled and the work covered by the Project Award is terminated in accordance with this article, at the direction of the OTAO, the CMF shall work with the Project Awardee to negotiate an equitable reimbursement.
13.4 Termination of Project Award. Any Project Award awarded pursuant to this Agreement may be terminated in whole or in part as set forth below:
13.4.1 By the OTAO unilaterally, should insufficient funds be available to accomplish the goals or intent of the Project Award or for other convenience to the Government. Such termination will be effective immediately upon written notice notwithstanding any prior notice requirement of this Agreement. In any event, thirty (30) calendar days prior written notice will be provided to the maximum extent practicable;
13.4.2 By the OTAO, with the consent of the Project Awardee through the CMF, based on an agreement by the Government and Project Awardee that the Project Award will not produce beneficial results commensurate with the expenditure of resources;
13.4.3 By the OTAO, with the consent of the Project Awardee through the CMF. In this case, the Parties shall agree upon the termination conditions, including the effective date and, in the case of partial termination, the portion to be terminated; or
13.4.4 By the Project Awardee, upon sending the OTAO through the RRPV CMF, a written notification, setting forth the reasons for such termination, the effective date and, in the case of partial termination, the portion to be terminated. The notice shall also include the total costs incurred or committed to date as well as projected costs for closeout. The Project Awardee must provide such notice at least sixty (60) calendar days prior to the effective date of the termination. No costs shall be incurred beyond those listed in the termination notice, unless otherwise agreed to by the OTAO. Upon receipt of the termination notice, the OTAO in consultation with the OTTR and PAR, will determine the appropriate path forward, which may include a full or partial transfer of tasks to another Project Awardee or Government entity, full or partial termination of the Project Award, or other mutual agreement between the Parties. If the OTAO determines, in the case of partial termination, that the reduced or modified portion of the Project Award will not accomplish the purposes for which the Project Award was awarded, the OTAO, through the CMF, may terminate the Project Award in its entirety.
13.5 Termination Caused by Material Breach by the Project Awardee. If the Project Awardee materially fails to comply with the provisions of a Project Award, the Project OTAO, after issuance of a notice through the RRPV CMF and failure of the Project Awardee to cure the defect within ten (10) days or the time allowed by the AO after receipt of the notice, may take one or more of the following actions as appropriate:
13.5.1 Temporarily withhold payments pending correction of the deficiency;
13.5.2 Disallow all or part of the cost of the activity or action not in compliance;
13.5.3 Wholly or partly suspend or terminate the current Project Award;
13.5.4 Withhold further funding for the Project Award; and
13.5.5 Take any other legally available remedies.
13.6 Termination Costs. The Parties will negotiate in good faith an equitable settlement for work performed under the Project Award, as appropriate. Costs incurred by the Project Awardee during a suspension or after termination of a Project Award are not allowable unless the OTAO, through the CMF, expressly authorizes them in either the notices of suspension, termination or subsequently. Other costs incurred during a suspension or after termination which are necessary and not reasonably avoidable may be allowable, as determined by the OTAO.
13.7 Close-out Procedures. If any Project Awards issued pursuant to this Agreement are completed or terminated, the following closeout procedures apply.
13.7.1 “Close-out” is the process by which the Government determines that all applicable administrative actions and all required work have been completed by the Project Awardee, the CMF, and the Government for a given project.
13.7.2 The Government shall obtain from the Project Awardee through the CMF within ninety (90) calendar days after the date of completion of the Project Award all financial, performance, and other reports required as the condition of the Project Award. The Government may grant extensions when requested by the RRPV CMF on behalf of the Project Awardee.
13.7.3 Quick close-out procedures similar to those found at FAR 42.708 shall be followed when possible.
13.7.4 When authorized at the Project Award level, the Government will make a settlement for any upward or adjustments to the Government’s share of costs, not to exceed the Government’s obligated amount, after these reports are received.
13.7.5 The Project Awardee, through the RRPV CMF, shall account for any property received from the Government.
ARTICLE 14. REPRESENTATIONS AND WARRANTIES
14.1 Representations and Warranties of All Parties. The Project Awardee represents that:
14.1.1 It is a validly existing legal or Government entity;
14.1.2 It is free to enter into this Agreement;
14.1.3 In so doing, it will not violate any other agreement to which it is a Party; and
14.1.4 It has taken all action necessary to authorize the execution and delivery of this Agreement and the performance of its obligations under this Agreement.
14.2 Limitations. Except as expressly provided herein, neither the Project Awardee, the CMF nor the Government makes any warranty, express or implied, either in fact or by operation of law, by statute or otherwise, relating to (a) any research conducted under this Agreement or (b) any invention conceived and/or reduced to practice under this Agreement or (c) any other intellectual property developed under this Agreement, and each one specifically disclaims any implied warranty of merchantability or warranty of fitness for a particular purpose.
ARTICLE 15. LIABILITY OF THE PARTIES
15.1 Waiver of Liability. With regard to the activities undertaken pursuant to this Agreement, no Party shall make any claim against another Party, another Party’s employees, another Party’s related entities (e.g., lower tier awardees, etc.) or employees of another Party’s related entities, or the Government, for any injury to or death of its own employees or employees of its related entities, or for damage to or loss of its own property or that of its related entities, whether such injury, death, damage, or loss arises through negligence or otherwise, except in the case of willful misconduct.
15.2 Damages. To the extent that a risk of damage or loss is not dealt with expressly in this Agreement, the Government and/or the Parties’ liability to the other Parties arising out of this Agreement whether or not arising as a result of an alleged breach of this Agreement, shall be limited to direct damages only, and shall not include any consequential, punitive, special and incidental damages, claims for lost profits, re-procurement costs, or other indirect or consequential damages.
15.3 Extension of Waiver of Liability. The Project Awardee agrees to extend the waiver of liability as set forth above to its sub-tier awards at any tier under the Project Award, and requiring them, by contract or otherwise, to agree to waive all claims against the Government and the CMF.
15.4 Applicability. Notwithstanding the other provisions of this article, this waiver of liability shall not be applicable to:
15.4.1 Claims between the CMF, Project Awardee, and/or the Government regarding a material breach or non-payment of funds for a Project Award,
15.4.2 Claims for damage caused by willful misconduct, or
15.4.3 IP claims.
15.5 Limitation of Liability. In no case will the financial liability of the Government, the CMF, or the Project Awardee exceed the amount obligated by the Government in connection to that Project Award. In no event shall the Parties be liable for claims for consequential, punitive, special and incidental damages, claims for lost profits, re-procurement costs, or other indirect damages. Each of the foregoing limitations on damages shall not apply to an action against the Government brought under 28 USC §1498. Nothing in this Article shall be construed to create the basis of a claim or suit where none would otherwise exist.
ARTICLE 16. DISPUTES
16.1 General. The Parties shall communicate with one another in good faith and in a timely and cooperative manner when raising issues under this Article. Whenever disputes, disagreements, or misunderstandings arise, the Parties shall attempt to resolve the issue(s) involved by discussion and mutual agreement as soon as practicable.
Any claim or dispute between the Parties concerning questions of fact or law arising from or in connection with this Agreement, and, whether or not involving an alleged breach of this Agreement, shall only be raised under this Article.
In no event shall a dispute, disagreement or misunderstanding that arose more than three (3) months prior to the notification made under this article constitute the basis for relief under this article unless the BARDA OTAO, in the interests of justice, waives this requirement.
Failing resolution by mutual agreement, the aggrieved Party shall document the dispute, disagreement, or misunderstanding by notifying the other Party in writing of the relevant facts, identifying unresolved issues, and specifying the clarification or remedy sought. Within ten (10) working days after providing notice to the other Party, the aggrieved Party may, in writing and through the CMF, request a decision to be rendered from a position at least one level above the BARDA OTAO.
The other Party shall conduct a review of the matter(s) in dispute and submit a written response on the matter(s) within thirty (30) calendar days after being notified that a decision has been requested. Any such decision is final and binding, unless a Party, within thirty calendar days, requests further joint review by senior officials (e.g., the CMF Chief Operating Officer, an ASPR official at least two levels above the OTAO, and/or senior executive of the Project Awardee). In such case, the senior officials shall conduct a review of the matter(s) in dispute and the senior Government official shall render a decision in writing within thirty (30) calendar days of receipt of such written position.
In the absence of a joint decision, or after appropriate exhaustion of the administrative and other remedies identified in this Agreement, either party may pursue any right or remedy provided by law in a court of competent jurisdiction. Alternatively, the parties may agree to explore and establish an Alternate Disputes Resolution procedure to resolve this dispute.
ARTICLE 17. REGULATORY TERMS
Specific regulations will be identified by the Government in Project Award documentation on a case-by- case basis, but may include:
17.1 Protection of Human Subjects.
17.1.1 The Project Awardee agrees that the rights and welfare of human subjects involved in research under this Agreement shall be protected in accordance with 45 CFR Part 46 and with the Project Awardee’s current Assurance of Compliance on file with the Office for Human Research Protections (OHRP), Office of Public Health and Science (OPHS). The Project Awardee further agrees to provide certification that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects, in accordance with 45 CFR Part 46 and the Assurance of Compliance.
17.1.2 The Project Awardee shall bear full responsibility for the performance of its work and services involving the use of human subjects under this Agreement and shall ensure that work is conducted in a proper manner and as safely as is feasible. The Project Awardee shall retain the right to control and direct the performance of all its work under this Agreement. Nothing in this Agreement shall be deemed to constitute any Project Awardee or any lower tier awardee, agent or employee of Project Awardee, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The Project Awardee agrees that it has entered into this Agreement and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent organization without imputing liability on the part of the Government for its acts or its employees.
17.1.3 If at any time during the performance of this Agreement, the HHS OTAO determines, in consultation with the OHRP, OPHS, and ASH, that the Project Awardee is not in compliance with any of the requirements and/or standards stated in Subparagraphs (1) and (2) above, the HHS OTAO may immediately direct the CMF to suspend, in whole or in part, work and further payments under this Agreement until the Project Awardee corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Project Awardee fails to complete corrective action within the period of time designated in the OTAO’s written notice of suspension, the HHS OTAO may, in consultation with OHRP, OPHS, and ASH, terminate the Project Award under this Agreement in a whole or in part, and the Project Awardee’s name may be removed from the list of those performers with approved Health and Human Services Human Subject Assurances.
17.2 Human Materials (Assurance of OHRP Compliance).
17.2.1 The acquisition and supply of all human specimen material (including fetal material) used under this Agreement shall be obtained by the Project Awardee in full compliance with applicable Federal, state and local laws and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.
17.2.2 The Project Awardee shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under this Agreement, by collaborating sites, or by sub-tier awardees, were obtained with prior approval by the Office for Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46 to protect human research subjects. This restriction applies to all collaborating sites without OHRP-approved Assurances, whether domestic or foreign, and compliance must be ensured by the Project Awardee.
17.2.3 Provision by the Project Awardee to the HHS OTAO, through the CMF, of a properly completed “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly Optional Form 310), certifying IRB review and approval of the protocol from which the human materials were obtained constitutes the written documentation required. The human subject certification can be met by submission of a self-designated form provided that it contains the information required by the “Protection of Human Subjects Assurance Identification/IRB Certification/ Declaration of Exemption”, Form OMB No. 0990-0263 (formerly Optional Form 310).
17.3 Research Involving Human Fetal Tissue. All research involving human fetal tissue shall be conducted in accordance with the Public Health Service Act, 42 U.S.C. 289g-1 and 289g-2. Implementing regulations and guidance for conducting research on human fetal tissue may be found at 45 CFR 46, Subpart B. The Project Awardee shall make available, for audit by the Secretary, HHS, the physician statements and informed consents required by 42 USC 289g-1(b) and (c), or ensure HHS access to those records, if maintained by an entity other than the Project Awardee.
17.4 Needle Exchange. The Project Awardee shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.
17.5 Care of Live Vertebrate Animals.
17.5.1 Before undertaking performance of any Project Award involving animal related activities, the Project Awardee shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR 2.25 through 2.28. The Project Awardee, through the CMF, shall furnish evidence of the registration to the OTAO.
17.5.2 The Project Awardee shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR 2.1 through 2.11, or from a source that is exempt from licensing under those sections.
17.5.3 The Project Awardee agrees that the care and use of any live vertebrate animals used or intended for use in the performance of this Agreement will conform with the PHS Policy on Humane Care of Use of Laboratory Animals, the current Animal Welfare Assurance, the Guide for the Care and Use of Laboratory Animals prepared by the Institute of Laboratory Animal Resources and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 1 - 4). In case of conflict between standards, the more stringent standard shall be used.
17.5.4 If at any time during performance of this Agreement, the OTAO determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Project Awardee is not in compliance with any of the requirements and/or standards stated above, the OTAO may immediately direct the CMF to suspend, in whole or in part, work and further payments under the Project Award until the Project Awardee corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Project Awardee fails to complete corrective action within the period of time designated in the OTAO’s written notice of suspension, the OTAO may, in consultation with OLAW, NIH, terminate the Project Award in whole or in part, and the Project Awardee’s name may be removed from the list of those entities with approved PHS Animal Welfare Assurances.
17.5.5 Note: The Project Awardee may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737.
17.6 Animal Welfare. All Project Awardee research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals. This policy may be accessed at: https://olaw.nih.gov/policies-laws/phs- policy.htm.
17.7 Protection of Personnel Who Work with Nonhuman Primates. All Project Awardee personnel who work with nonhuman primates or enter rooms or areas containing nonhuman primates shall comply with the procedures set forth in NIH Policy Manual 3044-2, entitled, "Protection of NIH Personnel Who Work with Nonhuman Primates," located at the following URL: https://policymanual.nih.gov/3044-2.
17.8 Information on Compliance with Animal Care Requirements.
17.8.1 Registration with the U. S. Dept. of Agriculture (USDA) is required to use regulated species of animals for biomedical purposes. USDA is responsible for the enforcement of the Animal Welfare Act (7 U.S.C. 2131 et. seq.), located at https://www.nal.usda.gov/animal-health- and-welfare/animal-welfare-act.
17.8.2 The Public Health Service (PHS) Policy is administered by the Office of Laboratory Animal Welfare (OLAW), located at https://olaw.nih.gov/. An essential requirement of the PHS Policy, available at https://olaw.nih.gov/policies-laws/phs-policy.htm, is that every institution using live vertebrate animals must obtain an approved assurance from OLAW before they can receive funding from any component of the U. S. Public Health Service.
17.8.3 The PHS Policy requires that Assured institutions base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals, available at https://grants.nih.gov/grants/olaw/guide-for-the-care-and-use-of-laboratory-animals.pdf, and that they comply with the regulations (9 CFR, Subchapter A), available at https://www.ecfr.gov/current/title-9/chapter-I/subchapter-A, issued by the U.S. Department of Agriculture (USDA) under the Animal Welfare Act. The Guide may differ from USDA regulations in some respects. Compliance with the USDA regulations is an absolute requirement of this Policy.
17.8.4 The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) http://www.aaalac.org is a professional organization that inspects and evaluates programs of animal care for institutions at their request. Those that meet the high standards are given the Accredited status. As of the 2002 revision of the PHS Policy, the only accrediting body recognized by PHS is the AAALAC. While AAALAC Accreditation is not required to conduct biomedical research, it is highly desirable. AAALAC uses the Guide as their primary evaluation tool. They also use the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching. It is published by the Federation of Animal Science Societies, available at https://www.fass.org/.
17.9 Approval of Required Assurance by Law. Under governing regulations, federal funds which are administered by BARDA shall not be expended by the Project Awardee for research involving live vertebrate animals, nor shall live vertebrate animals be involved in research activities under this award, unless a satisfactory assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 is submitted within 30 days of the date of each Project Award under this award and approved by OLAW. Each performance site (if any) must also assure compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 with the following restriction: Only activities that do not directly involve live vertebrate animals (i.e., are clearly severable and independent from those activities that do involve live vertebrate animals) may be conducted by the Project Awardee individual performance sites pending OLAW approval of their respective assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28. Additional information regarding OLAW may be obtained via the Internet at https://olaw.nih.gov/.
17.10 Registration with the Select Agent Program for Work Involving the Possession, Use, and/or Transfer of Select Biological Agents or Toxins
17.10.1 Work involving select biological agents or toxins shall not be conducted under this Agreement until the Project Awardee and any affected subawards are granted a certificate of registration or are authorized to work with the applicable select agents.
17.10.2 For Project Awards or sub-tier awards to domestic institutions who possess, use, and/or transfer Select Agents under this Agreement, the institution must complete registration with the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS) or the Animal and Plant Health Inspection Services (APHIS), U.S. Department of Agriculture (USDA), as applicable, before performing work involving Select Agents, in accordance with 42 CFR 73. No Government funds can be used for work involving Select Agents, as defined in 42 CFR 73, if the final registration certificate is denied.
17.10.3 For Project Awards or sub-tier awards to foreign institutions who possess, use, and/or transfer Select Agents under this contract, the Project Awardee must provide information satisfactory to the Government that a process equivalent to that described in 42 CFR 73 (https://www.ecfr.gov/current/title-42/chapter-I/subchapter-F/part-73) for U.S. institutions is in place and will be administered on behalf of all Select Agent work sponsored by these funds before using these funds for any work directly involving the Select Agents. The Project Awardee must provide information addressing the following key elements appropriate for the foreign institution: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the Select Agents, and any applicable laws, regulations and policies equivalent to 42 CFR 73. The Government will assess the policies and procedures for comparability to the U.S. requirements described in 42 CFR Part 73. When requested by the OTAO, through the CMF, the Project Awardee shall provide key information delineating any laws, regulations, policies, and procedures applicable to the foreign institution for the safe and secure possession, use, and transfer of Select Agents. This includes summaries of safety, security, and training plans, and applicable laws, regulations, and policies. For the purpose of security risk assessments, the Project Awardee must provide the names of all individuals at the foreign institution who will have access to the Select Agents and procedures for ensuring that only approved and appropriate individuals have access to Select Agents under the Project Agreement.
17.10.4 Listings of HHS select agents and toxins, biologic agents and toxins, and overlap agents or toxins as well as information about the registration process, can be obtained on the Select Agent Program web site at https://www.selectagents.gov/.
17.11 Product Licensure.
17.11.1 Any vaccines purchased, stored and distributed under this Agreement shall be manufactured under a current establishment and product licensure issued by the Food and Drug Administration.
17.11.2 The Project Awardee agrees to comply with cGMP guidelines (21 CFR Parts 210-211, 600) for manufacturing, processing and packing of drugs, chemicals, biological, and reagents.
17.11.3 The Project Awardee agrees to advise the OTAO, through the CMF, and OTTR immediately of any relocation of their manufacturing facility or the relocation of any sub-tier awardee’s facility. The Project Awardee also agrees to advise the OTAO, through the CMF, and OTTR immediately if at any time during the life of the Project Awards, the items under this Agreement fail to comply with cGMP guidelines and/or the facility receives a negative FDA Quality Assurance Evaluation (Form 483).
17.12 Final Distribution. Prior to expiration or termination of any Project Award, the Government may affect final distribution of any vaccines remaining in storage by any one or combination of the following methods:
17.12.1 The Government may elect to require shipment of the vaccine to US Government facilities or to state and local health agencies and/or other providers;
17.12.2 The Government may direct the Project Awardee to destroy all quantities remaining in storage at a charge to be negotiated between the parties. Such charges shall not exceed the actual costs incurred by the Project Awardee (or milestone value, if fixed price), and agreed to by the Government in advance of the destruction and/or disposal.
17.12.3 The Project Awardee cannot reclaim title to product upon acceptance.
17.13 Manufacturing Standards. The Current Good Manufacturing Practice Regulations (cGMP) (21 CFR 210-211) will be the standard applied for manufacturing, processing and packing of any therapeutic product developed under this Agreement. If at any time during the life of this contract, the Project Awardee fails to comply with cGMP in the manufacturing, processing and packaging of this therapeutic product and such failure results in a material adverse effect on the safety, purity or potency of this therapeutic product (a material failure) as identified by CBER and CDER, the Project Awardee shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure. If the Project Awardee fails to take such an action within the thirty (30) calendar day period, then the Project Award may be terminated.
17.14 Notwithstanding the paragraphs in this Article, updates to the regulatory requirements must be incorporated into Project Awards and may be discussed by the Parties to each individual Project Award on a case-by-case basis.
ARTICLE 18. GENERAL PROVISIONS
18.1 Consortium Members and the CMF. The relationship of the CMF and its Members established by the Consortium Member Agreement is of an independent nature and nothing contained in this Agreement shall be construed to (a) give the CMF or any Consortium Member hereto the power to direct or control the day to day activities of the Consortium or another Consortium Member hereto, (b) constitute the Consortium or Consortium Members as partners, joint ventures, co-owners or otherwise as participants in a joint or common undertaking, or (c) allow the Consortium or any of the Consortium Members hereto to create or assume any obligation on behalf of another Consortium Member hereto for any purpose whatsoever.
18.2 Parties Bound. This Agreement shall be binding upon and inure to the benefit of the Parties hereto, their respective successors, assigns, and legal representatives. Nothing herein shall be construed to give any Project Awardee subawards rights as a Party to or third-Party beneficiary of this Agreement.
18.3 Assignment. The Project Awardee may not transfer or assign this Agreement to any party without the Government’s written consent. Requests for consideration must be submitted to the Government, through the CMF, at least 30 calendar days prior to any proposed transfer or assignment.
18.4 Flow-Down Requirements. The Project Awardee shall include all relevant Articles in this Agreement, suitably modified in all subawards. These Articles shall, in turn, be included in all other forms of lower tier agreements, regardless of tier. The Government will be a third party in interest for purposes of these flow-down Articles of (5) Funding Obligation and Payments; (6) Administration; (7) Proprietary Information; (8) Rights in Data; (9) Inventions; (10) Foreign Access to Technology; (11) Publication and Publicity; (12) Term of the Agreement and Termination; (13) Consortium Membership Terms and Project Awards; (14) Representations and Warranties; (15) Liability of the Parties; (16) Disputes; and (18) General Provisions in any agreement where flow-down of rights and obligations is required.
18.5 Affiliates. The Parties hereto acknowledge that the Project Awardee’s Affiliates may carry out certain activities required or permitted pursuant to this Agreement. The Parties hereby represent and warrant that this Agreement shall be binding on their Affiliates in accordance with this Agreement as if such Affiliates were Parties to this Agreement. In the event that any Party to this Agreement is acquired by another company, the technology and programs of the acquiring company in existence at the time of such transactions shall not be subject to this Agreement, however the provisions of this Agreement shall continue with respect to all business conducted by the successor organization in connection to this Agreement.
18.6 Civil Rights Act. This Agreement is subject to the compliance requirements of Title VI of the Civil Rights Act of 1964 as amended (42 U.S.C. 2000-d) relating to the nondiscrimination in federally assisted programs.
18.7 Anti-Bribery and Anti-Corruption. Each Party agrees to perform its obligations under this Agreement in accordance with the applicable anti-bribery and anti-corruption laws of the territory in which such Party conducts business with the other Party as set forth herein. Each Party shall be entitled to exercise its termination right, under and in accordance with the terms of this Agreement, to terminate this Agreement immediately on written notice to the other Party, if the other Party fails to perform its material obligations in accordance with this Article.
18.8 Reporting Matters Involving Fraud, Waste, and Abuse. Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in ASPR funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll-free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing address is:
Office of Inspector General
Department of Health and Human Services TIPS HOTLINE
P.O. Box 23489
Washington, D.C. 20026
18.9 Prohibition on Involvement with Terrorist Activities. The Project Awardee acknowledges that U.S. Executive Orders and Laws, including but not limited to E.O. 13224 and P.L. 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the Project Awardee to ensure compliance with these Executive Orders and Laws. The Project Awardee shall ensure that any agreements entered into after the execution of this Agreement with an affiliate or subaward (regardless of tier) for any experimental, developmental, or research work that will be submitted for reimbursement under this Agreement are consistent with this Paragraph.
18.10 Foreign Owned Influence. The Project Awardee will ensure that no foreign entities from the Government’s prohibited sources list of embargoed and sanctioned countries, as defined by U.S. Departments of Treasury and Commerce, are utilized by the Project Awardee, or any of its Affiliates or subawards.
18.11 Entire Agreement. Unless otherwise specifically provided, this Agreement embodies the entire understanding between the Parties, and any prior or contemporaneous representations, either oral or written, are superseded. No amendments or changes to this Agreement’s terms shall be effective unless made in writing and signed by authorized representatives of the Parties as prescribed in Section 6.8.
18.12 Further Assurances. At any time or from time to time, the Project Awardee shall, at the request of the Government through the CMF:
18.12.1 Deliver to the CMF or the Government, such records, data, or other documents consistent with the provisions of this Agreement;
18.12.2 Execute, and deliver, or cause to be delivered, all such assignments, consents, documents, or further instruments of transfer or license; and
18.12.3 Take or cause to be taken all such other actions, as the Government may reasonably deem necessary or desirable in order for the Government to obtain the full benefits of the OTA and the transactions contemplated hereby.
18.13 Principal Investigator. The Project Award shall identify a Principal Investigator for each Project Award. This individual shall be continuously responsible for the conduct of the Project Award. The Project Awardee, through the CMF, shall obtain the OTAO’s approval to change the Principal Investigator or to continue the research work during a continuous period in excess of three months without the participation of an approved Principal Investigator. Each Project Award is based upon the Principal Investigator devoting a defined percentage of effort to the project over the term of the Project Award. The Project Awardee shall advise the OTAO, through the CMF, if the Principal Investigator will, or plans to, revise the level of effort estimated in the Project Proposal. A curriculum vitae shall be provided for professional associates added to the Project Award or substituted during the course of work.
18.14 Notices. Any notice or other communication required or permitted under this Agreement shall be in writing and (a) personally delivered or (b) sent by electronic mail to the appropriate Party or Parties at the addresses as set forth herein, or at such other addresses as may be given from time to time in accordance with the terms of this notice provision. Any notice or other communication given by personal delivery or electronic mail shall be deemed given on the date personally or electronically delivered. Appropriate points of contact to provide notice are listed in Article 6.
18.15 Non-Federal USG Personnel. The Project Awardee acknowledges and consents to the participation in this Agreement and subsequent Project Awards by non-federal Government personnel supporting this program (e.g., SME's). All non- federal USG personnel who participate in RRPV are strictly bound by appropriate non-disclosure requirements and comply with applicable law and regulation. By executing this Agreement, the Project Awardee consents to this participation throughout the Term of the Agreement.
18.16 Severability. In the event that any provision of this Agreement becomes or is declared by a court of competent jurisdiction to be illegal, unenforceable or void, this Agreement shall continue in full force and effect without said provision; provided that no such severability shall be effective if the result of such action materially changes the economic benefit of this Agreement to the Parties.
18.17 Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. The Project Awardee shall receive a copy of this executed Agreement and modifications thereto with the CMF retaining the originals.
18.18 Order of Precedence. In the event of any inconsistency between the terms of this Agreement and the terms of any Project Award made pursuant to this Agreement, the inconsistency shall be resolved by giving precedence in the following order: (1) the Project Award and the applicable Statements of Work, drawings, and specifications then (2) this Agreement.
18.19 Organizational Conflict of Interest (OCI). The Project Awardee will be expected to implement and maintain a comprehensive set of policies to address potential conflicts of interest, ethics, and disclosures to accomplish the work required by this Agreement and subsequent Project Awards. The Project Awardee shall notify the CMF of any real or potential Organization Conflicts of Interest throughout the Term of this Agreement.
18.20 Salary Rate Limitation.
Payment of the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date Government funding was initially obligated to the Project Award is an unallowable cost under this Agreement and shall be addressed in accordance with this paragraph.
For purposes of the salary rate limitation, the terms “direct salary,” “salary”, and “institutional base salary”, have the same meaning and are collectively referred to as “direct salary”, in this clause. An individual’s direct salary is the annual compensation that the Managing Entity pays for an individual’s direct effort (costs). Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Managing Entity. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative [F&A] costs).
Note: The salary rate limitation does not restrict the salary that an organization may pay an individual working under a Government contract, order, or Other Transaction; it merely limits the portion of that salary that may be paid with Federal funds.
The salary rate limitation also applies to individuals under subawards except to the extent that that a subaward is awarded on a fixed-price basis without analysis of labor costs. If a Project Award is a multiple-year agreement, it may be subject to unilateral modification by CMF, only as directed by the OTAO, to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act in effect when the expense is incurred regardless of the rate initially used to establish Project Award funding.
See the salaries and wages pay tables on the U.S. Office of Personnel Management (“OPM”) Web site for Federal Executive Schedule salary levels that apply to the current period.
Exhibit 10.2
THE SYMBOL “[***]” DENOTES PLACES WHERE CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE:
(i) THE COMPANY HAS DETERMINED THE OMITTED INFORMATION IS NOT MATERIAL, AND
(ii) THE COMPANY CUSTOMARILY AND ACTUALLY TREATS THE OMITTED INFORMATION AS PRIVATE OR CONFIDENTIAL
| RRPV Project Award Number: | 001 |
| RRPV Project Title: | RRPV-24-04-NGVx-006; Phase 2b study to evaluate GEO-CM04S1 COVID-19 Vaccine |
| UEI Number: | CEF5ULT44LF5 |
| PARTIES: | Advanced Technology International (RRPV Consortium Management Firm or CMF) and GeoVax, Inc. (Project Awardee) |
This RRPV Project Award is issued under the authority of the RRPV Base Agreement No. 2024-564, and incorporates all the terms and conditions thereof.
NOW, THEREFORE, the Parties hereto agree as follows:
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1. |
Payment Method |
The Payment Method for this Project Award is Expenditure-Based Milestone with a not to exceed ceiling.
|
2. |
Term of the Project Award |
The period of performance for this Project Award is from the effective date, which is the date of last signature, through November 29, 2027.
|
3. |
Obligation |
The CMF’s liability to make payments to the Project Awardee is limited to only those funds obligated under this Project Award or by modification to the Project Award. The CMF may incrementally fund this Project Award.
|
4. |
Estimated Cost |
The total estimated costs amount for the services to be provided by the Project Awardee are as follows:
| Estimated Cost | $24,321,841 |
The United States Government (USG) and GeoVax, Inc agree that the current award amount will be $24,321,841. Billable costs for the duration of the agreement will not exceed the total amount of $24,321,841 as any additional effort would require additional funds from the USG. Additional funds can be requested and may be approved, provided GeoVax, Inc has an acceptable technical justification. However, GeoVax, Inc acknowledges that any costs above an agreed upon contract ceiling amount of $45,000,000.00, to include potential indirect rate adjustments, will be the sole responsibility of GeoVax, Inc.
|
5. |
Limitation of Costs |
The total amount of funding currently allotted to this Project Award and available for payment is $24,321,841. Any work performed in excess thereof shall be at the Project Awardee’s risk. The Project Awardee shall notify the CMF if at any time the Project Awardee has reason to believe that the costs accrued in the next sixty (60) days will exceed seventy-five percent (75%) of the current total authorized funding. Such notice should confirm that the remaining funding is sufficient to perform the remaining work. The Project Awardee is not obligated to continue performance under this Project Award (including actions under the Termination clause of the RRPV Base Agreement) or otherwise incur costs in excess of the amount identified in this clause.
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6. |
Milestone Payment Schedule |
The Project Awardee shall segregate and track all Project Award costs separately and shall document the accomplishments of each milestone under each Project Award. Acceptance of milestones shall be contingent upon approval from the Government's Project Award Representative (PAR) detailed in the Technical and Administrative Representatives clause below. The Project Awardee shall invoice on a monthly basis based on actual incurred costs.
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7. |
Statement of Work |
The Statement of Work, Attachment A, provides a detailed description of the work and reports to be accomplished and delivered. All changes to Attachment A must be incorporated via written modification to this Project Award.
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8. |
Technical and Administrative Representatives |
The following technical and contractual representatives of the Parties are hereby designated for this Project Award. Either party may change their designated representatives by written notification to the other.
RRPV Consortium Management Firm Representative:
|
Rebecca Harmon, Sr. Contracts Manager |
|
Advanced Technology International |
|
315 Sigma Drive |
|
Summerville, SC 29486 |
|
Email: RRPV-contracts@ati.org |
|
Phone: (843) 760-3358 |
Project Award Representative (PAR):
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Lindsay Odell |
|
Email: Lindsay.Odell@hhs.gov |
|
Phone: 202-774-2413 |
RRPV Project Awardee’s Representatives:
|
Contractual Representative: |
Principal Investigator: |
|
Mark Reynolds, Chief Financial Officer |
Kelly T. McKee, Jr. MD, MPH, Chief Medical Officer |
|
GeoVax, Inc. |
GeoVax, Inc. |
|
1900 Lake Park Drive, Suite 380 Smyrna, GA 30080 |
1900 Lake Park Drive, Suite 380 Smyrna, GA 30080 |
|
Email: mreynolds@geovax.com |
Email: kmckee@geovax.com |
|
Phone: (678) 384-7220 |
Phone: (678) 384-7220 |
|
9. |
Marking of Deliverables |
Any Data delivered under this Project Award by the Awardee shall be marked with a suitable notice or legend.
|
10. |
Attachments |
Attachments listed herein are hereby incorporated by reference into this RRPV Project Award.
|
A. |
Statement of Work, “Phase 2b study to evaluate GEO-CM04S1 COVID-19 Vaccine” and Milestone Payment Schedule |
|
B. |
Key Tenets |
|
11. |
Government Furnished Property |
At this time, Government Furnished Property is not provided for use under this Project Award.
|
12. |
Publication and Publicity |
In accordance with Article 11 of the RRPV Base Agreement, any written announcements, press releases, or similar publicity with respect to the execution of this Project Award shall be agreed upon by the RRPV Consortium Manager, the Government, and the affected Consortium Member in advance of such Announcement. Refer to Article 11 of the RRPV Base Agreement for further information.
|
13. |
Data Rights |
The Offeror shall comply with the terms and conditions defined in the Base Agreement regarding Data Rights. It is anticipated that anything delivered under this proposed effort will be delivered to the Government with Unlimited Rights in technical data.
GeoVax elected to assert “limited data rights” for this project. Technical data to be furnished with restrictions are ***, ***, ***, ***, ***, and ***. Basis for the assertation is that the aforementioned technical data was previously developed exclusively at private expense.
|
14. |
Special Research Considerations |
Human Subjects – Offeror is to conduct all Human Subject Trials in accordance with Article 17.1 of the RRPV Base Agreement, entitled Protection of Human Subjects.
Human Specimen Material - Offeror is to conduct all trials pertaining to Human Specimen Material in accordance with Article 17.2 of the RRPV Base Agreement, entitled Human Materials (Assurance of OHRP Compliance).
|
15. |
Key Tenets |
The Project Awardee agrees that the Phase 2b clinical trial will be conducting in alignment with the Attachment B, “Key Tenets”.
|
16. |
Fair Pricing |
If, and for so long as, the product developed from this SOW is commercialized in the United States, in consideration of the Government’s investment, the parties intend for GeoVax to commercialize the product in accordance with the following principles:
If GeoVax commercializes a product in the United States for prevention of SARS-CoV-2 comprised solely of a COVID-19 vaccine for which BARDA invests $150,000,000 or more (in combination with this Agreement and in-kind support through partnerships with the Clinical Services Network), then, subject to applicable law, the list price (at wholesale acquisition cost) for commercial sales of such product in the United States following full licensure of the product, shall be substantially equivalent to or less than the approved price for commercial sales in High Income Countries outside of the United States; provided that such sales are comparable sales taking place within the same time period. GeoVax is permitted to take into account all relevant factors in determining whether sales are comparable sales, including volume commitments, timing of purchase and supply, the terms and conditions of purchase and supply, market conditions and epidemiology of SARS-CoV-2. Notwithstanding the foregoing, in the event any other manufacturer enters into an agreement with the Government providing for a similar investment from the Government for its anti-SARS-CoV-2 product and such agreement does not contain a substantially similar (or more onerous) requirement for commercial sales of its product, then the Government shall notify GeoVax of such other agreement and this clause shall cease to apply and shall be of no further force and effect, effective upon the execution of such other agreement. For purposes of this provision, High Income Countries shall mean Canada, France, Germany, Italy, Japan, Poland, Spain, United Kingdom, Australia, Chile, Saudi Arabia, South Korea and Taiwan, which are countries that, as of the date of award of this Contract, are World Bank high income countries (https://datahelpdesk.worldbank.org/knowledgebase/articles/906519) with populations greater than 20,000,000. The parties acknowledge that, over time, the foregoing criteria may result in a different list of High Income Countries. In any such case, the parties shall discuss and, upon mutual agreement, may change the countries included in the definition of High Income Countries.
|
17. |
Entire Agreement |
This Project Award and the RRPV Base Agreement under which it is issued constitute the entire understanding and agreement between the parties with respect to the subject matter hereof.
Except as provided herein, all Terms and Conditions of the RRPV Base Agreement and its modifications remain unchanged and in full force and effect.
The Project Awardee is required to sign this document and return to Advanced Technology International to finalize this action.
| GeoVax, Inc. | Advanced Technology International | |||
| By: | By: | |||
| Name: | Mark W. Reynolds | Name: | ||
| Title: | Chief Financial Officer | Title: | ||
| Date: | June 12, 2024 | Date: | ||
Attachment A
Statement of Work
Request for Project Proposals RPP: 24-04-NGVx
Project Identifier: RRPV-24-04-NGVx-006
Project Title: Phase 2b study to evaluate GEO-CM04S1 COVID-19 Vaccine
Organization Name: GeoVax, Inc.
Primary Place of Performance: GeoVax, Inc. Facilities, 1900 Lake Park Drive, Suite 380, Smyrna, GA 30080
1.0. Introduction/Background
The overarching goal of the outlined work is to demonstrate the efficacy of the GeoVax GEO-CM04S1 vaccine as a heterologous Coronavirus Disease 2019 (COVID-19) vaccine candidate, compared to that of a Food and Drug Administration (FDA) approved and commercially available COVID-19 vaccine. GeoVax plans to accomplish this through a Phase 2b randomized, double- blind, active-controlled study to evaluate clinical efficacy, immunogenicity, and safety. Individuals recruited for this clinical study will be highly diverse with respect to age, ethnicity and comorbidities, reflecting both healthy adults and populations at risk for serious or fatal disease associated with SARS-CoV-2 infections. GeoVax proposes conducting this work in two periods:
1) Phase 2b trial execution (base period) and 2) additional exploratory analyses and other unplanned analyses (option 1). The work will be executed over the course of approximately 42 months (3 years, 6 months). It is expected that the base period and option period will be executed concurrently.
GeoVax is the Prime Offeror (Sponsor) and will hold the ultimate responsibility for activities supporting the on-time and on-budget completion of the effort by the CRO within the scope. GeoVax will work with the assigned partners from the Clinical Studies Network (CSN). The CSN will be responsible for clinical trial execution. GeoVax will contract with EverGlade, an organization that specializes in the management of government contracts that will support project management, budget monitoring, invoicing, and contract compliance efforts. GeoVax will contract with Oxford Biomedica SAS (France) for manufacturing activities.
GeoVax will also partner with vendors for the execution of analytical analyses. GeoVax will work with Adaptive Biotechnologies to conduct T-cell receptor (TCR) beta chain immunosequencing and with Revvity for all other cellular immunogenicity assays. GeoVax will also work with Cerba Research USA, Inc for live virus neuralization analysis.
GeoVax will partner with additional vendors for the JN.1 lineage scope. Southern Research Institute will conduct toxicity and immunogenicity animal studies and City of Hope will conduct immune testing on already collected Wuhan samples.
2.0. Scope/Project Objective
GeoVax proposes to advance the clinical development of next-generation vaccine (the GeoVax GEO-CM04S1 or the JN.1 lineage construct) into a Phase 2b clinical trial. The efficacy and immunogenicity of the GeoVax GEO-CM04S1 vaccine as a heterologous COVID-19 vaccine candidate will be compared to that of an FDA approved and commercially available COVID-19 vaccine. GeoVax will conduct the work in two periods:
|
1. |
Base Period: Support clinical trial execution primary and secondary endpoint analyses, and immunogenicity endpoint analyses |
|
2. |
Option Period 1: Execution of exploratory endpoints analyses & unplanned analyses. It is expected that both periods will take place concurrently. |
GeoVax will perform this work with support of two subcontractors and five key vendors:
|
● |
EverGlade (Subcontractor 1 – Base/Option 1): Support of project management, budget monitoring, invoicing, and contract compliance efforts |
|
● |
Oxford Biomedica SAS (FR) (Subcontractor 2 – Base): Manufacturing |
|
● |
Cerba Research USA, Inc. (Key Vendor 1 - Base): Live Virus Neutralization Analysis |
|
● |
Southern Research Institute (Key Vendor 2 – Base): Toxicity and Immunogenicity Animal Studies |
|
● |
City of Hope (Key Vendor 3 – Base): Immune Testing for Current Clinical Samples (Wuhan) |
|
● |
Adaptive Biotechnologies (Key Vendor 4 – Option 1): TCR Beta-Chain Immunosequencing |
|
● |
Revvity (Key Vendor 5 – Option 1): All Other Cellular Immunogenicity Assays |
3.0. Requirements
|
1. |
Base Period: Clinical Trial Planning and Readiness |
|
1.1. |
Technical Project Management |
The Performer shall collaborate with the CSN to provide the following as outlined below and in the contract deliverables list:
The overall management, integration, and coordination of all contract activities, including a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and direction of all contract activities.
1.1.1. A Principal Investigator (PI), in conjunction with the CSN, is responsible for oversight and coordination of the project, ensuring that communication, tracking, monitoring, and reporting on status, progress, and modification to the project requirements and timelines, including projects undertaken by subcontractors are executed and delivered on time and within budget. The contract deliverables list identifies all contract deliverables and reporting requirements for this statement of work.
1.1.2. A Project Manager (PM) is responsible for managing and administering project activities, for monitoring and tracking day-to-day progress and timelines, coordinating communication and project activities, costs incurred, and program management. The contract deliverables list identifies all contract deliverables and reporting requirements for this statement of work.
1.1.3. A liaison with responsibility for effective communication with the Agreements Officer (AO) and Project Agreement Representative (PAR). The liaison may be the PI or PM.
1.1.4. Administrative and legal staff with responsibility for developing compliant subcontracts, consulting, and other legal agreements; ensuring timely acquisition of all proprietary rights, including intellectual property (IP) rights; and reporting all inventions made in the performance of the contract.
1.1.5. Administrative staff with responsibility for financial management and reporting on all activities conducted by the Performer and any subcontractors.
1.1.6. Contract Meetings
1.1.6.1. Contract Initiation Meeting
1.1.6.2. The Performer shall participate in regular meetings to coordinate and oversee the contract effort conjointly with BARDA. Such meetings may include, but are not limited to, meeting of the Performers and subcontractors as well as BARDA CSN partners to discuss clinical manufacturing progress, product development, product assay development, scale-up manufacturing development, clinical sample assays development, preclinical/clinical study designs and regulatory issues; meetings with individual Performers and other government officials to discuss the technical, regulatory, and ethical aspects of the program; and meetings with technical consultants to discuss technical data provided by the Performer.
1.1.6.3. The Performer shall participate in teleconferences every month with the AO and PAR to discuss the performance of the contract. Teleconferences or additional face-to- face meetings may be more frequent at the request of the AO.
1.1.7. Integrated Master Schedule (IMS): Within 30 calendar days of the effective date of the contract, GeoVax shall contribute to and review a first draft of an updated IMS in a format agreed upon by BARDA and the CSN to the Project Officer and the Agreements Officer for review and comment. The IMS shall be used to monitor the performance of the contract relative to the SOW. The key milestones and Go/No Go decision gates shall be included. The IMS for the period of performance will be accepted by BARDA.
1.1.8. Integrated Master Plan (IMP): Within 90 calendar days of the effective date of the contract, GeoVax shall submit an IMP in a format agreed upon by RRPV to the Project Agreement Representative and the Agreements Officer.
1.1.9. Go/No-Go Decision Gates: The IMP outlines key milestones with “Go/No-Go” decision criteria (entrance and exit criteria for each phase of the project). The project plan will include, but not be limited to, milestones in manufacturing, non-clinical and clinical studies, and regulatory submissions. Trial start will depend on both GeoVax and CSN readiness.
1.1.9.1. Decision Gate Reporting: Upon completion of a stage of the product development, as defined in the agreed upon IMS and IMP, GeoVax and relevant CSN contributors (specific to each decision gate), shall prepare and submit to the AO and PAR a Decision Gate Report that contains (i) sufficient detail, documentation, and analysis to support successful completion of the stage according to the predetermined qualitative and quantitative criteria that were established for Go/No-Go decision making; and (ii) a description of the next stage of product development to be initiated and a request for approval to proceed to the next stage of product development.
1.1.10. Risk Management Plan: GeoVax will work with the assigned clinical partners to develop a risk management plan within 90 days of contract award highlighting potential problems and/or issues that may arise during the life of the contract; their impact on cost, schedule, and performance; and appropriate remediation plans. This plan should reference relevant WBS elements where appropriate. Updates to this plan shall be included, at a minimum, on a quarterly basis (every three months) in the monthly Project Status Report (see 1.1.14). PMBR: Performer shall submit a plan for a PMBR to occur within 90 days of contract award. At the PMBR, Performer and the government shall mutually agree upon the budget, schedule, and technical plan baselines (Performance Measurement Baseline [PMB]). These baselines shall be the basis for monitoring and reporting progress throughout the life of the contract. The PMBR is conducted to achieve confidence that the baselines accurately capture the entire technical scope of work, are consistent with contract schedule requirements, are reasonably and logically planned, and have adequate resources assigned.
1.1.11. Deviation Request: During the course of contract performance, in response to a need to change IMS activities as baselined at the PMBR, GeoVax shall submit a Deviation Report. This report shall request a change in the agreed upon IMS and timelines. This report shall include: (i) discussion of the rationale/justification for the proposed change;
(ii) options for addressing the needed changes from the agreed upon timelines, including a cost-benefit analysis of each option; and (iii) recommendations for the preferred option that includes a full analysis and discussion of the effect of the change on the entire product development program, timelines, and budget.
1.1.12. Monthly and Annual Reports: GeoVax shall contribute to Project Status Reports on a monthly basis. The reports shall address the items below cross referenced to the SOW, WBS, and IMS or other Project Management Plan tool(s): i. Executive summary highlighting the progress, issues, and relevant manufacturing, non-clinical, clinical, and regulatory activities; ii. Progress in meeting contract milestones, detailing the planned progress and actual progress during the reporting period, explaining any differences between the two and corrective steps; iii. Updated IMS; iv. Updated EVM/other Project Monitoring Tool(s); v. Updated Risk Management Plan (every three months); vi. Three- month rolling forecast of planned activities; vii. Progress of regulatory submissions; and
viii. Estimated and actual expenses.
1.1.13. Final Technical and Business Status Report: GeoVax will submit a draft final project status report to BARDA for review. Reports shall include Technical and Business Status sections. GeoVax will make subsequent revisions to the draft for finalization.
|
1.2. |
JN.1 Lineage Construct |
1.1.1. Pre-Master Virus Seed (MVS): GeoVax will produce pre-MVS (including gene synthesis, virus rescue, isolation of single clones, and amplification of virus clones). GeoVax will qualify the material and complete an in-house expansion.
1.1.2. Manufacturing
1.2.1.1. Order Supplies: GeoVax will partner with Oxford Biomedica (France) (OXB FR) for manufacturing activities. GeoVax will work with OXB FR to order supplies needed for GMP (Good Manufacturing Practice) Manufacturing.
1.2.1.2. Pre-MVS Testing: Pre-MVS stock will be tested at OXB FR for sterility, mycoplasma, and titer, and full genomic sequencing will be performed.
1.2.1.3. GMP Manufacture of 1 MVA COVID GMP MVS Batch: OXB FR will use the tested pre-MVS produced by GeoVax for the manufacture of a JN.1 GMP MVS batch using the full scale (*** m2) CEF DS (Drug Substance) production process. Release testing will be performed by OXB FR.
1.2.1.4. GMP Manufacture of MVA COVID GMP Drug Substance (DS) Batches: OXB FR will manufacture *** JN.1 GMP DS batches using the full scale (*** m2) CEF DS production process. Release testing will be performed by OXB FR.
1.2.1.5. GMP Manufacture of MVA COVID GMP Drug Product (DP) Batches: OXB FR will manufacture *** JN.1 GMP DP batches using the process according to the defined procedures and material and manufacturing specifications previously approved by GeoVax and OXB FR to produce GEO-CM04S1 (Wuhan). Release testing will be performed by OXB FR. DP vials will be labeled and packaged.
1.2.1.6. Analytical Methods Feasibility Studies and/or Qualification: Additional feasibility and qualification of analytical methods will be performed as needed.
1.2.1.7. Stability Studies: Real-time stability studies for the GMP MVS, GMP DS and GMP DP will be performed. Accelerated stability will be performed on GMP DP. In addition, intermediate short-term stability will be performed.
1.1.1. Non-GLP Immunogenicity Mouse Study: GeoVax will work with Southern Research Institute to conduct an immunogenicity study in C57BL/6 mice. GeoVax will seek appropriate protocol approvals before performing the study.
1.1.2. GLP Toxicology & Immunogenicity: GeoVax will work with Southern Research Institute to conduct a GLP compliant repeat dose acute toxicokinetic study in New Zealand White Rabbits. Assay validation will be performed. GeoVax will seek appropriate protocol approvals before performing the study.
1.1.3. Regulatory (JN.1 Lineage): GeoVax will submit a Chemistry, Manufacturing, and Control (CMC) Investigational New Drug (IND) for each batch. GeoVax will provide any IND updates required for the study as its role as the Sponsor to include safety reporting.
1.2. Clinical
1.2.1. Immune Testing – Current Clinical (Wuhan) Samples: GeoVax will work with City of Hope to perform immune analysis (pseudovirus neutralization testing) on previously collected Phase 1 and Phase 2a clinical samples.
1.2.2. Clinical Operations/Management: GeoVax will provide information needed for a ClinicalTrials.Gov registration and confirm and contribute to project plans, including the data management plan, sample management plan, monitoring plan, statistical analysis plan, and recruitment, enrollment, and diversity plan. The monitoring plan will be the responsibility of the CSN with GeoVax providing input. GeoVax will also confirm all needed study tracking systems are in place.
1.2.2.1. Go/No-Go Milestone: BARDA Review & Approval of Project Plans & Final Protocol
1.2.3. Develop Study-Specific Documents: GeoVax will develop and finalize an Investigational Brochure (IB). GeoVax will work with CSN to develop and finalize an informed consent form (ICF).
1.2.4. Safety Oversight Committee (SOC): GeoVax will support the CSN in the development of a Safety Oversight Committee (SOC). GeoVax will participate in an initial SOC meeting and all future meetings, as appropriate.
1.2.5. Site Readiness Activities: GeoVax will provide any input to the CSN in the performance of site evaluation visits (SEV) / site qualification visits.
1.2.6. Site Activation: GeoVax will support the CSN in the completion of site initiation visits (SIVs) if needed.
1.2.7. Study Execution: GeoVax will participate in regular meetings with the study execution team.
1.2.8. Analytical Assays: GeoVax will confirm desired analytical assays, specifications, and parameters. Once analytical assays are confirmed, GeoVax will ensure databases for assay outputs are established by all relevant partners and vendors. The central laboratory (as part of the CSN) will conduct analytical assays. Other assays, if agreed upon in writing by the PAR and AO, may be conducted by external vendors.
1.2.9. Site Close-Out Activities: GeoVax will support the CSN in completion of site Close-Out Visits (COVs) as needed.
1.2.10. Post-Trial Support and Follow-Up Activities: GeoVax will assist in the coordination of sending samples for reconciliation and submission of final vendor invoices/payments/contract close-outs. GeoVax shall submit, with collaboration from the CSN, a final status report on clinical activities. GeoVax will ensure a quality check of the electronic trial master file (eTMF) is performed.
1.2.11.
1.3. Regulatory
1.3.1. Clinical Trial Material Readiness: GeoVax will release the clinical material from GMP manufacturer.
1.3.2. IND Activities: GeoVax will submit a CMC IND update report as well as an IND Amendment . GeoVax will submit annual IND updates. GeoVax will provide any IND updates required for the study as its role as the Sponsor to include safety reporting.
1.3.3. Investigational Review Board (IRB): GeoVax will support the CSN as needed to facilitate an initial IRB submission and receive a study-level IRB approval.
2. Option Period 1: Additional Analytical Analysis
2.1. Technical Project Management: Project management activities in Option Period 1 will be similar to those performed in the Base Period.
2.2. Clinical
2.2.1. Analytical Analysis: GeoVax will partner with key vendors, Revvity, Adaptive Biotechnologies and Cerba Research USA, Inc, who will perform assays that support secondary/exploratory immunogenicity and live virus serology endpoints of the clinical trial as determined in the base period. Assays to be performed include live virus neutralization on serum samples (Cerba), FluoroSpot and Flow Cytometry on local and centrally processed PBMCs (Revvity), and TCR sequencing from whole blood (Adaptive). Activities will include an interim data analysis and final data readouts/report for secondary/exploratory endpoints. Any additional unplanned analyses will also be performed.
4.0. Deliverables Table
|
1. |
Meetings |
|
# |
Deliverable |
Deliverable Description |
Reporting Procedures and Due Dates |
|
1.1 |
Post Award Teleconference |
The Performer must complete an initial teleconference after the initiation of the period of performance.
1. Outline activities for the next 30 days 2. Discuss agenda items for the post-award Kickoff Meeting |
● Within 5 business days after the initiation of the Project Award period of performance ● Performer must submit agenda and establish a teleconference number at least 3 business days in advance of the teleconference unless notified that BARDA will supply a teleconference number ● PAR edits/approves and instructs Performer to distribute agenda at least 2 business days prior to meeting ● Performer submits meeting minutes to PAR within 3 business days after the meeting ● PAR reviews, comments, and approves minutes within 10 business days
|
|
1.2 |
Kickoff Meeting |
The Performer must complete a Kickoff meeting after the initiation of the period of performance. |
● Within 10 business days after the initiation of the period of performance, pending concurrence by the OTAO ● Performer must submit agenda and itinerary, if applicable, at least 5 business days in advance of in-person meeting or teleconference ● PAR edits/approves and instructs Performer to distribute agenda at least 3 business days prior to meeting ● Performer submits meeting minutes to PAR within 3 business days after the meeting ● PAR reviews, comments, and approves minutes within 10 business days
|
|
1.3 |
Weekly Teleconference |
The Performer must participate in teleconferences weekly with BARDA to discuss the technical performance on the project. Meeting frequency may be increased or decreased as needed during the course of the project. |
● Performer must submit agenda to PAR no later than 3-4 business days in advance of meeting ● PAR edits/approves and instructs Performer to distribute agenda prior to meeting ● Performer must distribute agenda and presentation materials at least 2 calendar days in advance of meeting ● Performer must submit meeting minutes to PAR within 3 business days of the meeting ● PAR reviews, comments, and approves minutes within 6 business days
|
|
1.4 |
Technical, Subgroup, Ad Hoc Teleconference(s) |
The Performer must participate in technical, subgroup, or ad hoc teleconferences as needed or upon BARDA request to discuss the technical performance on the Project Award.
Meeting frequency may be defined as needed during the course of the project. |
● Performer must submit agenda to PAR no later than 2 business days in advance of Technical or Subgroup meeting ● PAR edits/approves and instructs Performer to distribute agenda prior to meeting ● Performer must distribute agenda and presentation materials at least 24 hours in advance of meeting ● Performer must submit meeting minutes to PAR within 3 business days of the meeting ● PAR reviews, comments, and approves minutes within 6 business days
|
|
1.5 |
Periodic Review Meetings |
At the discretion of the Government, the Performer must hold up to four per year recurring Project Review Meetings, held by teleconference or face-to face either in Washington, D.C. or at work sites of the Performer or subperformer. Face-to-face meetings may alternate between Washington, D.C. and Performer, subperformer sites. The meetings will be used to discuss project progress in relation to the Program Management deliverables described in this Project Award as well as nonclinical, clinical, technical, regulatory, and ethical aspects of the program. |
● Performer must submit an agenda and itinerary, if applicable, at least 5 business days in advance of meeting, and Performer must provide presentation materials at least 3 business days in advance of the meeting ● PAR edits/approves and instructs Performer to distribute agenda at least 3 business days prior to meeting ● Performer provides meeting minutes to PAR within 3 business days after the meeting ● PAR reviews, comments, and approves minutes within 10 business days |
|
1.6 |
FDA Meetings and Interactions |
The Performer must forward the dates and times of any meeting with the FDA to BARDA, including formal meetings, site visits, inspections, audits, ad hoc meetings, technical meetings, etc.
The Performer must arrange for up to four (4) BARDA staff to attend any FDA meeting. (BARDA staff typically include the PAR and three (3) subject matter experts). |
● Performer must notify BARDA of any and all upcoming FDA meetings at minimum within 24 hours of meeting request. This includes formal (Type A, B, or C meetings or any and all other technical meetings). ● Performer must provide advance copies of any PAR respondence it plans to send to FDA. ● Performer must provide within 24 hours of its receipt, unredacted copies of all written communications it receives from the FDA. ● Performer must notify BARDA within 24 hours of any informal or ad hoc meeting occurrence. ● The Performer must forward initial Performer-issued draft minutes AND final minutes of any meeting with the FDA to BARDA within 2 business days of receipt. |
|
1.7 |
Daily check-in with BARDA in the event of a PHE |
Upon request of the Government, the Performer must participate in a daily check-in update with the project staff (via teleconference or email).
The updates will address key cost, schedule, and technical updates. Daily updates may be shared with senior Government leaders and should be provided on a non- confidential basis, unless the update includes confidential information in which case Performer must provide the update in both confidential and non-confidential formats.
Daily check-ins may occur on weekdays, excluding federal holidays.
Upon request of the Government, check-ins may also occur on weekends and on federal holidays, provided at least 24 hours’ notice |
● A standing agenda must be used, to include key cost, schedule, technical updates, as well as updates on ad hoc communications between the USG and the Performer. ● No meeting minutes are required ● Performer must provide bulleted email updates following any call or in lieu of a call by 2:00PM ET for that day. |
|
2. |
Technical Reporting: General |
|
# |
Deliverable |
Deliverable Description |
Reporting Procedures and Due Dates |
|
2.1 |
Project Management Plan (PMP) |
The Project Management Plan should define the overall plan for how the project will be executed, monitored, and controlled and must include a Study Responsibility Assignment Matrix for Performer and Subperformer team(s).
The PMP may be a single detailed document or composed of one or more subsidiary planning documents. These additional planning documents provide guidance and direction for specific management, planning, and control activities such as schedule, cost, risk, staffing, change control, communications, quality, procurement, deployment, etc. Each of the subsidiary planning documents should be detailed to the extent required by the specific project. |
● The Performer must submit a Project Management Plan (PMP) o Within 30 calendar days after the initiation of the period of performance o Updates should be provided to reflect any key changes and the PMP shall be reviewed at least annually. |
|
2.2 |
Gantt Chart/Timeline of the project |
The Gantt Chart/Timeline should be detailed to the extent required by the specific project. |
At first project meeting and as updated no later than every 30 calendar days. Provided in pdf. |
|
2.3 |
Communication Plan |
The Performer must develop and implement an effective Communication Plan that details the flow of information between BARDA, Performers, collaborators, vendors, and other organizations, including communications with all parties, as appropriate, regarding label contents, expiry dating, and healthcare provider educational materials.
The Communication Plan must also include a press release review process. |
● Performer must submit a Communication Plan o Within 30 calendar days after the initiation of the period of performance o Updates should be provided to reflect any key changes and be reviewed at least annually from the date of award |
|
2.4 |
Performer Locations |
Using BARDA-defined template, the Performer must submit detailed data regarding locations where work will be performed under this Project Award, including addresses, points of contact, and work performed per location, to include SubPerformers and critical vendors of reagents and supplies. |
● Performer must submit Work Locations Report: o Within 5 business days after the initiation of the period of performance o Within 30 business days after a substantive location or capabilities change
|
|
Performer must include vendors for critical infrastructure protection. |
● Within 2 business days of a substantive change if the work performed supports medical countermeasure development that addresses a threat that has been declared a Public Health Emergency by the HHS Secretary or a Public Health Emergency of International Concern (PHEIC) by the WHO |
||
|
2.5 |
Pandemic/Public Health Emergency Facility and Operational Management Plan |
Performer must develop a Pandemic Facility and Operational Management Plan, including change procedures from normal to pandemic operations and continuity of operations in the event of a declared pandemic emergency. Performer must identify critical infrastructure. |
● The Performer must submit Pandemic Management Plan: o Draft within 15 days of award o Final within 30 days of award |
|
2.6 |
Request for Information (RFI) Responses |
Upon request of the Government, the Performer must provide complete responses to ad hoc RFIs.
RFIs may address key cost, schedule, and technical updates. Responses may be shared with senior Government leaders and should be provided on a non- confidential basis, unless the response includes confidential information in which case Performer must provide the response in both confidential and non-confidential formats. |
● Performer must submit an RFI response to BARDA by email within 24 hours after Performer receipt of the RFI. |
|
2.7 |
Monthly & Annual Technical Progress Reports/Annual Meeting |
The Monthly and Annual Technical Progress reports must address each of the below items and be cross- referenced to the Work Breakdown Structure (WBS), Statement of Work (SOW), and Integrated Master Schedule (IMS), and Contract Performance Report (CPR) – or as applicable. 1. An Executive Summary highlighting the progress, issues, and relevant manufacturing, nonclinical, clinical, regulatory, and publication activities. The Executive Summary should highlight all critical issues for that reporting period and resolution approach; limited to 2 pages 2. The Performer must submit monthly detailed clinical reports during active clinical trial enrollment to include at a minimum: ● Central Institutional Review Board (IRB)approval status ● Site IRB approval status ● Site information (Federal Wide Assurance (FWA) number, site type (e.g., commercial site, academic site), site activation status) |
● The Performer must submit monthly reports on the 15th day of the month covering the preceding month; Annual Reports submitted on the last calendar day of the month after each contract anniversary. Monthly progress reports are not required for the months when the Annual Report(s) are due, and Monthly/Annual Report(s) are not due during a month when the Final Report (final version, not draft) is due. The PAR and OATO will review the monthly reports with the Performer and provide feedback ● Performer must provide FINAL versions of reports within 10 business days after receiving BARDA comments/edits ● Performer must provide notification of designated safety events to the OTAO and PAR within 24 hours of being notified of the event. The PAR and OTAO will review the monthly reports with the Performer and provide feedback ● Performer must provide FINAL versions of reports within 10 business days after receiving BARDA comments/edits |
|
● Number of subjects screened and enrolled by age, race, ethnicity, geographic distribution ● Investigational Product status (receipt at depot and receipt on site) ● Safety reporting (Serious Adverse Event) ● Protocol deviations ● Database management ● Status of ancillary supplies e.g., Personal Protection Equipment, swabs, syringes, tubes on site ● Specimen collection status ● Pharmacy manuals
The Performer must inform BARDA of any upcoming site visits and/or audits of Clinical Research Organization (CRO) facilities funded under this effort. BARDA reserves the right to accompany the Performer on site visits and/or audits of CROs as BARDA deems necessary.
3. Progress in meeting milestones organized by WBS, overall project assessment, problems encountered and recommended solutions. The reports must detail the planned and actual progress during the period covered, explaining any differences between the two and the corrective steps 4. A three-month rolling forecast of the key planned activities, referencing the WBS/IMS 5. A tracking log of progress on regulatory submissions with the FDA number, description of submission, date of submission, status of submission, and next steps |
● Performer must provide notification of designated safety events to the OTAO and PAR within 24 hours of being notified of the event |
|
6. Estimated and Actual Expenses ● This report must also contain a narrative or table detailing whether there is a significant discrepancy (>10%) at this time between the % of work completed and the cumulative costs incurred to date. Monthly and actual expenses should be broken down to theappropriate WBS level. This section of the report should also contain estimates for the Subperformers’ expenses from the previous month if the Subperformer did not submit a bill in the previous month. If the Subperformer(s) was not working or did not incur any costs in the previous month, then a statement to this effect should be included in this report for those respective SubPerformers. If the PAR and OTAO are satisfied that the Performer’s reporting is sufficient to convey this information, this section may be waived.
Publication activities and progress for any manuscript, scientific meeting abstract, poster, presentation, and other public-facing material or information containing data generated under this Project Award
|
|||
|
2.8 |
Draft and Final Technical Progress Report |
A draft Final Technical Progress Report must contain a summation of the work performed and the results obtained over the entire period of performance. This report must be in sufficient detail to fully describe the progress achieved under all milestones. Report must contain a timeline of originally planned and baselined activities and milestones overlaid with actual progress attained during the Project Award. Descriptions and rationale for activities and milestones that were not completed as planned should be provided. The draft report must be duly marked as ’Draft.’
The Final Technical Progress Report should incorporate feedback received from BARDA and contain a summation of the work performed and the results obtained for the entire Project Award Period of Performance (PoP). The final report must document the results of the entire Project Award. The final report must be duly marked as ’Final’. A cover letter with the report will contain a summary (not to exceed 200 words) of salient results achieved during the period of performance. |
● The Performer must submit the Draft Final Technical Progress Report 75 calendar days before the end of the PoP and the Final Technical Progress Report on or before the completion date of the PoP ● PAR will provide feedback on draft report within 21 calendar days of receipt, which the Performer must consider incorporating into the Final Report |
|
3. |
Physical Inventory Deliverables |
|
# |
Deliverable |
Deliverable Description |
Reporting Procedures and Due Dates |
|
3.1 |
Draft and Final Nonclinical Study Report(s) |
Performer must provide Draft and Final Nonclinical Study Reports to BARDA for review and comment. |
● Draft report due within 45 calendar days after completion of analysis and at least 15 business days prior to submission to FDA ● Performer must submit SubPerformer- prepared reports received by the Performer to the PAR and OTAO for review and comment no later than 5 business days after receipt by Performer. ● The Government will provide written comments to the Draft Report for Nonclinical Study Reports within 15 business days after the submission ● Final report due 30 calendar days after receiving comments on the Draft Final Report for Non-Clinical Studies; If corrective action is recommended, Performer must address all concerns raised by BARDA in writing ● Performer must consider revising reports to address BARDA’s recommendations prior to FDA submission |
|
3.2 |
Nonclinical Study Protocols |
The Performer must submit draft and final nonclinical study protocols to PAR. |
● The Performer must submit Draft nonclinical study protocols to PAR electronically prior to finalization. o BARDA will provide comments within 10 business days of receipt of draft protocol o Performer must respond in writing to BARDA comments and recommendations within 10 business days of receipt and must be addressed prior to finalization of protocol. o OTAO must approve the final protocol ● The Performer must submit Final nonclinical study protocols to PAR electronically no later than 10 business days prior to FDA submission. |
|
3.3 |
Nonclinical Study Final Data Submission Package |
BARDA must have access to methods and reagents. BARDA must have unlimited rights to all nonclinical-related protocols, data generated from the execution of these protocols, and final reports, funded by BARDA under this contract At BARDA’s request, the Performer must provide any nonclinical-related contract deliverable without any restrictive legends to ensure BARDA has the ability to review and distribute the nonclinical-related deliverables, as BARDA deems necessary. |
● Performer must submit at least 15 business days prior to contract end date. Partial datasets may also be requested for delivery prior to submission of the Final Data Submission Package. |
|
4. |
Technical Reporting: Clinical Trials |
|
# |
Deliverable |
Deliverable Description |
Reporting Procedures and Due Dates |
|
4.1 |
Clinical Trial Protocols |
The Performer must collaborate with BARDA and the CSN partner to provide a protocol agreeable to all parties. |
o ● The Performer must submit Final study protocols to PAR electronically no later than 10 business days prior to FDA submission.
|
|
4.2 |
Clinical Trial Documentation1 |
The Performer will collaborate with BARDA and the CSN partner to provide documents agreeable to all parties: ● Investigational Product Accountability Plan ● Study Supplies Procurement Plan ● Site selection questionnaire ● Overall Recruitment and Retention plan ● Informed Consent Form (ICF) template ● eConsent ● Data Management Plan ● Data Validation/Quality Plan ● Statistical Analysis Plan ● Sample/Specimen Management` Plan ● Diversity inclusion plan to enroll based on US demographic based on most recent census ● Investigator Brochure ● electronic Case Report Form (eCRF) ● Community engagement materials, posters, media advertisements, animations, graphics, etc. ● Clinical Trial Agreements ● Monitoring Plan ● Safety Monitoring Plan (processes to provide 24-7 pharmacovigilance and safety monitoring) |
o ● The Performer must submit Final study documents, including the Statistical Analysis Plan to PAR electronically no later than 10 business days prior to FDA submission. ● ● Performer must submit final version Investigational Product and Clinical Supplies Management Plan as time agreed upon by BARDA and the CSN at least 6 weeks prior to investigational product shipments to clinical depot. ● Performer must retain the capability to procure, ship, deliver, install, and train on the use of all required supplies, including, but not limited to, documents, files, and equipment. ● Final TLFs must be submitted to the PAR 3 weeks after database lock. |
1To be added at the discretion of the Agreements Officer and the Project Agreement Representative and PCT as appropriate for the contract, e.g., if the clinical trial utilizes NIH-funded clinical sites: The Performer must participate in and provide information to a USG-oversight and review committee(s) outside of BARDA. The Performer must submit protocol, ICF, and IB to a Protocol Science Review Committee (PSRC) four (4) business days before the review to the PSRC Chair and USG-designated reviewers.
|
● SAE Reconciliation SOP (if safety database is separate from clinical database) ● Processes to manage and support an independent DSMB ● DSMB Charter ● DSMB template reports and DSMB reports ● Draft and Final Tables, Listings, and Figures (TLFs), ad hoc TLFs ● Plan for notifying participants of his/her treatment assignment ● Essential Regulatory Documents that demonstrate compliance with the standards of ICH E6 (R2) Good Clinical Practice and with all applicable regulatory requirements ● Pharmacy Manual
|
|||
|
4.3 |
ClinicalTrials.Gov Posting and Results Reporting |
Per clinicaltrials.gov registration and reporting requirements. |
● Performer must post results: o 3 months from any interim analysis o 3 months from primary analysis o 3 months from final analysis |
|
4.4 |
Draft and Final Clinical Study Report(s) |
Performer must collaborate with CSN partner to provide Draft and Final Clinical Study Reports to BARDA for review and comment. |
GeoVax will review draft Report for Clinical Studies Reports within 15 business days after submission |
|
4.5 |
Project-Specific First Site Activated for First Subject First Visit |
Performer should collaborate with CSN to have all pre-study planning complete and be ready to enroll subjects. |
After IND is in effect, within five days of IRB approval |
|
4.6 |
Clinical Report During Active Enrollment Periods |
N/A |
N/A |
|
4.7 |
Access to Electronic Systems Used in Trial Conduct |
The Performer must provide access to systems used in trial conduct. |
Due within 20 calendar days of PAR request, no later than ten calendar days prior to first site activated |
|
4.8 |
Blinded Safety Reports, Medical Data Listing, CIOMS Report, Pharmacovigilance Database Listing |
N/A |
N/A |
|
4.9 |
Specimen Collection for Future Use |
The CSN will collect and store clinical samples at key immune time points for future use in immune assays to be conducted at a central laboratory(s) as determined by BARDA.
For additional assays, the performer must provide an agreed upon plan for additional sample needs and shipment plans.
These samples and associated clinical data (metadata) will be-managed by the CSN
The CSN will remove any personal identifying information (PII) from the samples and assign each with a unique subject identification number and unique specimen identifier that links the Visit ID, Subject ID, and the clinical data before transferring to Geovax. |
● ● Specimens and associated clinical data will be transferred from the CSN to Geovax upon request by BARDA |
|
4.10 |
Clinical Trial Final Study Package |
BARDA must have unlimited rights to all clinical-related protocols, data generated from the execution of these protocols, and final reports, funded by BARDA under this contract. At BARDA’s request, the Performer must provide any clinical-related contract deliverable without any restrictive legends to ensure BARDA has the ability to review and distribute the clinical-related deliverables, as BARDA deems necessary. If clinical trial data is included, that data must be provided consistent with applicable privacy laws to protect personally identifiable information (PII). |
Performer must submit the Clinical Trial Final Study Package at least 15 business days prior to contract end date. Partial datasets may also be requested for delivery prior to submission of the Final Data Submission Package. |
|
4.11 |
Data Exchange Package(s) Submitted to Regulatory Agency(s) |
As part of Final or Draft Submission Package(s), upon BARDA request, and also as part of deliverables, the Performer must provide raw data, Tabulation Data (e.g., CDISC- compliant SDTM SAS XPT datasets), Analysis Datasets (e.g., CDISC- compliant ADaM SAS XPT datasets), and any additional documents including but not limited to Reviewer’s Guide (PDF), SDTM annotated CRF(s) (PDF), and data definition file(s) (XML) to BARDA. Other data exchange standards or file formats might be used if discussed with and agreed by BARDA. The Performer must provide the software programs (e.g., SAS programs, R programs) used to create any ADaM datasets and generate tables and figures associated with all analyses, including primary and secondary efficacy analyses. List of abbreviations: XPT = SAS Transport Format (XPORT) Version 5;PDF = Portable Document Format; XML = Extensible Mark-up Language; CDISC = Clinical Data Interchange Standards Consortium |
Performer must provide the Technical Documents and/or datasets within 20 business days of request from the OTAO or PAR |
|
4.12 |
Clinical Trial Datasets |
Performer must make clinical trial datasets publicly available. |
● Performer must post clinical trial datasets on a web-based platform easily accessible by the public: o 3 months from any interim analysis o 3 months from primary analysis o 3 months from final analysis |
|
4.13 |
Additional Data Package(s) |
Upon request, the Performer must provide raw data, tabulation Data and/or analysis data in a BARDA- agreed upon format and supporting documents that might be including but not limit to the list of files in package, technical specification documents, data analysis programs. Data exchange standards and file formats must be discussed and agreed upon with BARDA. |
● Performer must provide the data package(s) within 20 business days of request from the PAR or OTAO. |
|
5. |
Technical Reporting: Quality Assurance |
|
# |
Deliverable |
Deliverable Description |
Reporting Procedures and Due Dates |
|
5.1 |
Quality Management Plan (QMP) |
Performer must develop an overall project Quality Management Plan to include a description of all quality activities and personnel involved in ensuring all activities are conducted and data are maintained under cGXP, and all products are managed to ensure that GMP requirements are met. All quality management plans must include subPerformer quality management plans specifically addressing how subPerformer quality will be managed. All subPerformers must have a current quality agreement with the Performer and a recent vendor qualification audit. |
● Performer must submit a Quality Management Plan o Within 30 calendar days after the initiation of the contract period of performance o On the 6th month agreement anniversary to include any updates. |
|
5.2 |
BARDA Audit |
Performer must accommodate periodic or ad hoc site visits, auditing, inspection and review of release documents, test results, equipment and facilities when requested by HHS. If BARDA, the Performer, or other parties identify any issues during an audit, the Performer must capture the issues, identify potential solutions and submit a report to BARDA detailing the finding and corrective action(s). HHS reserves the right to conduct an audit, either by HHS and/or HHS designee(s), of the facilities used under this contract and all records related to the manufacture, testing (including but not limited to analytical testing, nonclinical study, clinical trial), and storage of the product. |
● If issues are identified during the audit, Performer must submit a report to BARDA detailing the finding and corrective action(s) within 10 business days of the audit ● PAR and OTAO will review the report and provide a response to the Performer with 10 business days ● Once corrective action is completed, the Performer will provide a final report to BARDA |
|
5.3 |
FDA Inspections/Site visits |
In the event of an FDA inspection that occurs in relation to this agreement and for the product, or for any other FDA inspection that has the reasonable potential to impact the performance of this agreement, including, but not limited to clinical trials and manufacturing facilities, the Performer must provide the USG with an exact copy (non- redacted) of the FDA Form 483 or summary and the Establishment Inspection Report (EIR). The Performer must provide the PAR and OTAO with copies of the plan and FDA submissions for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines as identified in the inspection report, status updates during the plan’s execution and a copy of all final responses to the FDA. The Performer must also provide redacted copies of any FDA inspection reports received from subPerformers that occur as a result of this contract or for this product. The Performer must make arrangements for up to four (4) BARDA representative(s) to be present during the opening, any daily debriefs, and the final debrief by the regulatory inspector. |
● Draft report due within 45 calendar days after completion of analysis and at least 15 business days prior to submission to FDA ● Performer must notify PAR and OTAO within 10 business days of the scheduling of a scheduled FDA inspection/site visit or within 24 hours after inspection/site visit if the FDA does not provide advanced notice ● Performer must provide copies of any FDA inspection report received from subPerformers that occur as a result of this contract or for this product within 1 business day of receiving correspondence from the FDA, a subPerformer, or third party ● Within 10 business days of inspection report, Performer must provide OTAO with a plan for addressing areas of nonconformance, if any are identified |
|
5.4 |
Quality Assurance Audits and SubPerformer Monitoring Visits |
BARDA reserves the right to participate in QA audits performed by the Performer. Upon completion of the audit/site visit the Performer must provide a report capturing the findings, results and next steps in proceeding with the subPerformer. If action is requested of the subPerformer, detailed concerns for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to BARDA. The Performer must provide responses from the subPerformers to address these concerns and plans for corrective action. The Performer must allow for up to four (4) USG representative(s) to be present during the audit as necessary for appropriate oversight, including manufacturing person in plant, at nonclinical sites, at clinical sites, CROs, and any other clinical vendor involved in the conduct of the nonclinical study or clinical trial under contract. |
● Performer must notify AO and PAR a minimum of 10 business days in advance of upcoming, audits/site visits of subPerformers ● Performer must notify the PAR and AO within 5 business days of report completion and provide Draft Report. ● PAR and AO will review the report and provide a response to the Performer with 10 business days before audit can be finalized. ● Performer must provide a final audit report and corrective and preventive actions (CAPAs) to address all findings in the report. ● Performer must provide a final closeout report that all CAPAs were addressed to PAR and OATO ● Performer must notify BARDA within 24 hours of any critical and/or major findings |
|
5.5 |
Risk Management Plan (RMP) |
The Performer must provide an RMP that outlines the impacts of each risk in relation to the cost, schedule, and performance objectives. |
● A Draft is due within 45 calendar days after the initiation of the contract period of performance; updates to the RMP are due concurrent with Monthly Technical Progress Reports but may be communicated more frequently. The Performer may choose to notify the government up to two times every three months if there are no changes from the prior submission, and not submit an update ● BARDA will provide Performer with a list of concerns in response plan submitted ● Performer must address, in writing, all concerns raised by BARDA within 20 business days of Performer’s receipt of BARDA’s concerns ● The Performer must submit updates at minimum of every three months. |
|
5.6 |
Integrated Master Schedule (IMS) |
The Performer must provide an IMS that illustrates project tasks, dependencies, durations throughout the period of performance, and milestones (GO/NO-GO). The IMS must map to the WBS, and provide baseline, and actual or forecast dates for completion of tasks. |
● The Performer must submit the IMS in both PDF and an agreed-upon electronic format (e.g., Microsoft Project) to the PAR ● The first Draft of the IMS is due within 30 business days after the initiation of the contract period of performance ● The Government will request revisions within 10 business days, at which point the schedule baseline for the period of performance will be set ● Thereafter an updated IMS is due concurrent with Monthly Technical Progress Reports ● During a declared Public Health Emergency, the Performer must submit the IMS within 10 business days after the initiation of the contract period of performance, updates are due weekly, and any significant change (i.e., a change which would impact the schedule by greater than one week) must be reported immediately to the PAR and/or designee. |
|
5.7 |
Deviation Notification and Mitigation Strategy |
Process for changing IMS activities associated with cost and schedule as baselined. Performer must notify BARDA of significant proposed changes the IMS defined as increases in cost above 5% or schedule slippage of more than 30 days, which would require a PoP extension. Performer must provide a high- level management strategy for risk mitigation. |
● The Performer must submit Deviation Notification and Mitigation Strategy at least 10 business days prior to the Performer anticipating the need to implement changes |
|
5.8 |
Incident Report |
Performer must communicate to BARDA and document all critical programmatic concerns, issues, or probable risks that have or are likely to significantly impact project schedule and/or cost and/or performance. “Significant” is defined as a 10% or greater cost or schedule variance within a control account, but should be confirmed in consultation with the PAR. Incidents that present liability to the project even without cost/schedule impact, such as breach of GCP during a clinical study, must also be reported. |
● Due within 48 hours of activity or incident or within 24 hours for a security activity or incident ● Email or telephone with written follow-up to PAR and AO ● Additional updates due to PAR and AO within 48 hours of additional developments ● Performer must submit within 5 business days a Corrective Action Plan (if deemed necessary by either party) to address any potential issues ● If corrective action is deemed necessary, Performer must address in writing, its consideration of concerns raised by BARDA within 5 business days of receiving such concerns |
|
6. |
Advanced R&D Products |
|
# |
Deliverable |
Deliverable Description |
Reporting Procedures and Due Dates |
|
6.1 |
Technical Documents |
Upon request, Performer must provide the PAR with deliverables from the following activities: quality agreements between Performers and sub-Performer, process Development Reports, Assay Qualification Plan/Report, Assay Validation Plan/Report, Assay Technology Transfer Report, Batch Records, SOPs, Master Production Records, Certificate of Analysis, Clinical Studies Data or Reports, clinical trial documents. The OTAO and PAR reserve the right to request within the PoP a non-proprietary technical document for distribution within the Government3. |
● Performer must provide technical document within 10 business days of OTAO or PAR request. Performer can request additional time on an as needed basis ● If corrective action is recommended, the Performer must address, in writing, concerns raised by BARDA in writing |
| 6.2 | Publications |
The Performer must submit any manuscript, scientific meeting abstract, poster, presentation, and any other public-facing material or information disseminated outside the purview of other deliverables, containing data generated under this contract, to BARDA for review prior to submission. Acknowledgment of BARDA funding must be included as noted in contract article X. |
● Performer must submit all manuscript or scientific meeting abstracts to PAR and OATO prior to submission/presentation by 30 business days for manuscripts and 15 business days for abstracts, posters, or any other material ● Performer must address in writing all concerns raised by BARDA in writing ● Final submissions must be submitted to BARDA concurrently or no later than within one (1) calendar day of its submission ● Performer must list all publication material in the Monthly Technical Progress Report |
|
6.3 |
Performer Clinical Publication Timeline and USG Right to Publish Data |
The Performer and Government are committed to transparent and timely publication of clinical trial data to ensure rapid distribution of information during a Public Health Emergency. Within 30 days of the primary analysis, results from clinical studies funded in whole or in part under this Project Agreement and consistent with Good Publications Practices. Sponsor, Performer must submit clinical study primary endpoint analysis for publication to a peer reviewed journal. Within 90 days of the of study end date [last subject last visit] for studies funded in part or whole under this contract and consistent with Good Publication Practices, Performer must submit clinical study data for publication to a peer reviewed journal. If the Performer does not elect to publish data, Performer must provide OTAO and PAR with clinical trial data to support the government publication of data as deemed appropriate by the government, without the Performer’s involvement. The government reserves the right to publish a counter-analysis of the data. |
● Performer must notify OTAO and PAR within 30 calendar days of primary analysis results and study end date [last subject last visit] if they plan not to publish data. ● Within 10 calendar days of a request for clinical data from the OTAO, the Performer must provide OTAO with requested data, information and materials in the form(s) requested by the government, to support the government publication of the clinical trial data funded in part or whole under this Project Agreement |
|
6.4 |
Performer Nonclinical Publication Timeline and USG Right to Publish Data |
The Performer and Government are committed to transparent and timely publication of nonclinical data to ensure rapid distribution of information, particularly during a Public Health Emergency. Within 90 days of the of study end date [audited or quality-controlled draft final report prepared and reviewed by the Government] for studies funded in part or whole under this Project Agreement and consistent with Good Publication Practices, The Performer must submit nonclinical study data for publication to a peer-reviewed journal. If the Performer does not elect to publish data, Performer must provide OTAO and PAR with nonclinical data to support the government publication of data as deemed appropriate by the government, without the Performer involvement. The government reserves the right to publish a counter-analysis of the data. |
● Performer must notify OTAO within 30 calendar days of study end date [audited or quality-controlled draft final report prepared and submitted for Government review] if they plan not to publish data. ● Within 10 calendar days of a request for nonclinical data from the OTAO, the Performer must provide OTAO with requested data, information and materials in the form(s) requested by the government, to support the government publication of the nonclinical trial data funded in part or whole under this contract |
|
7. |
Regulatory Deliverables |
|
# |
Deliverable |
Deliverable Description |
Reporting Procedures and Due Dates |
|
7.1 |
Regulatory Strategy/Plan |
The Performer must provide a Regulatory Plan that outlines the regulatory strategy for the product. The plan must include information leading to commercialization readiness. |
● The Performer must submit a Draft within 45 calendar days after the initiation of the contract period of performance; updates to the Regulatory Strategy/Plan must be submitted concurrently with Monthly Technical Progress Reports. The Performer may choose to notify the government up to two times every three months if there are no changes from the prior submission, and not submit an update ● BARDA will provide Performer with a list of concerns in response to plan submitted ● Performer must address, in writing, all concerns raised by BARDA within 20 business days of Performer’s receipt of BARDA’s concerns |
|
7.2 |
FDA Correspondence |
The Performer must memorialize all original and unredacted correspondence between Performer and FDA and submit to BARDA, including formal and informal emails, correspondence, telephone calls, and official information requests (IRs). |
● Performer must provide copies of all original and unredacted FDA correspondence within 2 business days of correspondence |
|
7.3 |
FDA Submissions |
The Performer must provide BARDA the opportunity to review and comment upon all draft submissions before submission to the FDA. Performer must provide BARDA with an electronic copy of the final FDA submission. All documents must be duly marked as either “Draft” or “Final.” |
● Performer must submit draft FDA submissions to BARDA at least 15 business days prior to FDA submission ● BARDA will provide feedback to Performer within 10 business days of receipt ● The Performer must address, in writing, its consideration of all concerns raised by BARDA prior to FDA submission ● The Performer must submit Final FDA submissions to BARDA concurrently or no later than five (5) calendar days of submission |
5.0. Milestone Schedule
|
GeoVax, Inc. Milestone Payment Schedule1 |
|||||
|
RRPV Milestone Number |
Task Number |
Significant Event/ |
Due Date |
Government Funds |
Total Funding |
|
1 |
1.1 |
Contract Initiation Meeting |
7/1/2024 |
*** |
$ 3,653,206 |
|
2 |
N/A |
Monthly Report (Technical and Business Reports) |
7/15/2024 |
*** |
*** |
|
3 |
1.3 |
Go/No-Go Milestone: Analytical Assays Confirmed |
8/5/2024 |
*** |
*** |
|
4 |
N/A |
Monthly Report (Technical and Business Reports) |
8/15/2024 |
*** |
*** |
|
5 |
1.4 |
Go/No-Go Milestone: IND Amendment in Approved |
8/26/2024 |
*** |
*** |
|
6 |
N/A |
Monthly Report (Technical and Business Reports) |
9/15/2024 |
*** |
*** |
|
7 |
1.4 |
Go/No-Go Milestone: IRB Approval Received (Study Level) |
9/23/2024 |
*** |
*** |
|
8 |
1.3 |
Go/No-Go Milestone: RRPV Review & Approval of Project Plans & Final Protocol |
9/30/2024 |
*** |
*** |
|
9 |
1.4 |
Milestone: First Site IRB Approval Received |
10/8/2024 |
*** |
*** |
|
10 |
1.3 |
Go/No-Go Milestone: All Lab Qualification Visits Complete |
10/14/2024 |
*** |
*** |
|
11 |
N/A |
Monthly Report (Technical and Business Reports) |
10/15/2024 |
*** |
*** |
|
12 |
1.3 |
Go/No-Go Milestone: Final Study Materials Developed & Ready |
11/1/2024 |
*** |
*** |
|
13 |
N/A |
Monthly Report (Technical and Business Reports) |
11/15/2024 |
*** |
*** |
|
14 |
N/A |
Monthly Report (Technical and Business Reports) |
12/15/2024 |
*** |
*** |
|
15 |
N/A |
Monthly Report (Technical and Business Reports) |
1/15/2025 |
*** |
*** |
|
16 |
1.4 |
Milestone: All Sites IRB-Approved |
2/19/2025 |
*** |
*** |
|
17 |
N/A |
Monthly Report (Technical and Business Reports) |
2/15/2025 |
*** |
*** |
|
18 |
N/A |
Monthly Report (Technical and Business Reports) |
3/15/2025 |
*** |
*** |
|
19 |
N/A |
Monthly Report (Technical and Business Reports) |
4/15/2025 |
*** |
*** |
|
20 |
1.2 |
Go/No-Go Milestone: Analytical Assays Confirmed |
5/12/2025 |
*** |
*** |
|
21 |
N/A |
Monthly Report (Technical and Business Reports) |
5/15/2025 |
*** |
*** |
|
22 |
1.3 |
Milestone: First Site Activated |
5/21/2025 |
*** |
*** |
|
23 |
1.3 |
Milestone: First Participant In |
5/29/2025 |
*** |
*** |
|
24 |
N/A |
Monthly Report (Technical and Business Reports) |
6/15/2025 |
*** |
*** |
|
25 |
N/A |
Annual Report |
7/31/2025 |
*** |
*** |
|
26 |
N/A |
Monthly Report (Technical and Business Reports) |
8/15/2025 |
*** |
*** |
|
27 |
N/A |
Monthly Report (Technical and Business Reports) |
9/15/2025 |
*** |
*** |
|
28 |
1.3 |
Go/No-Go Milestone: All site readiness & site activation activities |
10/3/2025 |
*** |
*** |
|
29 |
1.3 |
Milestone: 50% Participants Enrolled |
10/6/2025 |
*** |
*** |
|
30 |
N/A |
Monthly Report (Technical and Business Reports) |
10/15/2025 |
*** |
*** |
|
31 |
N/A |
Monthly Report (Technical and Business Reports) |
11/15/2025 |
*** |
*** |
|
32 |
N/A |
Monthly Report (Technical and Business Reports) |
12/15/2025 |
*** |
*** |
|
33 |
N/A |
Monthly Report (Technical and Business Reports) |
1/15/2026 |
*** |
*** |
|
34 |
N/A |
Monthly Report (Technical and Business Reports) |
2/15/2026 |
*** |
*** |
|
35 |
N/A |
Monthly Report (Technical and Business Reports) |
3/15/2026 |
*** |
*** |
|
36 |
N/A |
Monthly Report (Technical and Business Reports) |
4/15/2026 |
*** |
*** |
|
37 |
N/A |
Monthly Report (Technical and Business Reports) |
5/15/2026 |
*** |
*** |
|
38 |
N/A |
Monthly Report (Technical and Business Reports) |
6/15/2026 |
*** |
*** |
|
39 |
N/A |
Annual Report |
7/31/2026 |
*** |
*** |
|
40 |
N/A |
Monthly Report (Technical and Business Reports) |
8/15/2026 |
*** |
*** |
|
41 |
N/A |
Monthly Report (Technical and Business Reports) |
9/15/2026 |
*** |
*** |
|
42 |
N/A |
Monthly Report (Technical and Business Reports) |
10/15/2026 |
*** |
*** |
|
43 |
N/A |
Monthly Report (Technical and Business Reports) |
11/15/2026 |
*** |
*** |
|
44 |
N/A |
Monthly Report (Technical and Business Reports) |
12/15/2026 |
*** |
*** |
|
45 |
1.3 |
Milestone: Last Participant In |
12/30/2026 |
*** |
*** |
|
46 |
N/A |
Monthly Report (Technical and Business Reports) |
1/15/2027 |
*** |
*** |
|
47 |
N/A |
Monthly Report (Technical and Business Reports) |
2/15/2027 |
*** |
*** |
|
48 |
1.3 |
Milestone: Database Lock |
3/11/2027 |
*** |
*** |
|
49 |
N/A |
Monthly Report (Technical and Business Reports) |
3/15/2027 |
*** |
*** |
|
50 |
N/A |
Monthly Report (Technical and Business Reports) |
4/15/2027 |
*** |
*** |
|
51 |
N/A |
Monthly Report (Technical and Business Reports) |
5/15/2027 |
*** |
*** |
|
52 |
2.2 |
Milestone: Final Data Readouts / Data Analysis |
6/18/2027 |
*** |
*** |
|
53 |
N/A |
Monthly Report (Technical and Business Reports) |
6/15/2027 |
*** |
*** |
|
54 |
N/A |
Annual Report |
7/31/2027 |
*** |
*** |
|
55 |
2.1 |
Milestone: Final Additional Analytical Analyses Report |
7/23/2027 |
*** |
*** |
|
56 |
1.3 |
Milestone: Final CSR |
8/6/2027 |
*** |
*** |
|
57 |
N/A |
Monthly Report (Technical and Business Reports) |
8/15/2027 |
*** |
*** |
|
58 |
N/A |
Monthly Report (Technical and Business Reports) |
9/15/2027 |
*** |
*** |
|
59 |
N/A |
Monthly Report (Technical and Business Reports) |
10/15/2027 |
*** |
*** |
|
60 |
N/A |
Final Reports (POP End) |
11/29/2027 |
*** |
*** |
|
Total: |
$ 24,321,841 |
$ 24,321,841 |
|||
|
Contract Type: |
CR |
||||
Footnote:
1. GeoVax, Inc. is proposing a cost reimbursable agreement. This milestone payment schedule should not be interpreted as what may or may not be invoiced to the Government for reimbursement on a monthly basis. GeoVax, Inc. is not proposing a fixed priced agreement.
6.0. INTELLECTUAL PROPERTY, DATA RIGHTS, AND COPYRIGHTS
|
Technical Data to Be Furnished with Restrictions |
Basis for Assertion |
Asserted Rights Category |
Name of Asserting Organization |
Milestone Affected |
|
*** |
Previously developed exclusively at private expense
|
Limited |
GeoVax, Inc |
5 |
Attachment B
Key Tenets
Next Generation COVID-19 Vaccines Tenets
The largest effort in the Next Generation COVID-19 Vaccines Area of Interest will focus on generation of proof-of-concept Phase IIb efficacy data from multiple development partners to de-risk further development of successful vaccine candidates that are delivered via mucosal administration, target other non-spike proteins, or target multiple SARS-CoV-2 receptor binding domains that Chanmay strengthen vaccine breadth, durability, and transmission-blocking. As part of this effort, BARDA plans to conduct correlate of protection (COP) and immunogenicity analyses, as well as meta-analyses using aggregate data to inform a better understanding of mechanistic correlates to further development of COVID-19 vaccines and improve responses to future pandemics or public health threats. Alignment of objectives/endpoints, implementation of a Diversity Plan, use of a Data Safety Monitoring Board (DSMB), standardized data collection, and a uniform approach to the collection and analysis of immunogenicity data across the Next Generation COVID-19 Vaccines initiative facilitates a harmonized strategy that ensures BARDA’s strategic goals for the program are met. Adherence with the requirements set forth below to provide samples and data are critical for BARDA to strengthen its assays and analytical infrastructure to advance COPs and accelerate licensure of NextGen vaccines. The following conditions pertaining to operationalization of the Phase 2b clinical trials have been set as a requirement to entering into an agreement whereby the USG collaborates and helps finance the development of Next Generation COVID-19 Vaccines.
|
1) |
The vaccine developer to the collaboration will be the sole Sponsor and holder of the IND. |
Responsibilities:
|
Clinical Studies Network Partnership |
BARDA Broad Agency Announcement/Rapid Response Partnership Vehicle |
|
Responsibility and accountability for the operational execution of the trial |
Responsibility and accountability for the operational execution of the trial |
|
Final selection, approval, and activation of sites |
Final selection, approval, and activation of sites |
|
Fulfilling monitoring responsibilities in all sites |
Fulfilling monitoring responsibilities in all sites |
|
Sponsor Transfer of Regulatory Obligations (TORO); assume BARDA CRO SOPs will be followed |
Sponsor TORO as needed |
|
2) |
The study protocols will be harmonized with respect to the defined primary efficacy endpoint, the minimal common set of secondary endpoints, and statistical analysis plans (SAPs). Specific secondary or exploratory endpoints can be included for each program. Execution of each Phase 2b clinical trial requires written authorization from BARDA. |
|
3) |
Awardees must provide protocol development and writing support services, including the development of protocol-related documents such as sample informed consents. Protocol development and subsequent trial enrollment must take into consideration and align with diversity of the clinical trial population and as applicable take into account principles outlined in ‘Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry’ https://www.fda.gov/regulatory-information/search-fda-guidance- documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices- and-trial |
|
4) |
Awardees must provide a Diversity Plan to improve enrollment of participants based on ‘Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry’ (Draft January 2024) https://www.fda.gov/regulatory- information/search-fda-guidance-documents/collection-race-and-ethnicity-data-clinical-trials-and- clinical-studies-fda-regulated-medical?utm_medium=email&utm_source=govdelivery. The Diversity Plan must include proposed targets to achieve deliverable. The Diversity Plan should include how PBMCs will be collected from a diverse population. |
| 5)
|
The Phase 2b clinical trials must be overseen by a Data and Safety Monitoring Board (DSMB) fulfilling all standard duties of DSMBs. The criteria for voting members and non-voting observer members of the DSMB as well as the final composition of the DSMB will be set by BARDA in consultation with the vaccine developer and finalization will require agreement from BARDA. 1-2 BARDA representatives will attend all safety committee meeting open sessions as non-voting observers. |
| 6)
|
Protocols will be harmonized with respect to using the FDA Guidance ‘Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials’ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/toxicity-grading- scale-healthy-adult-and-adolescent-volunteers-enrolled-preventive-vaccine-clinical for the purpose of grading adverse events. |
| 7)
|
Clinical Data Collection will be harmonized with respect to using the latest Clinical Data Interchange Standards Consortium (CDISC) Clinical Data Acquisition Standards Harmonization (CDASH) Model for eCRF design. The current version of CDASH can be downloaded at: https://www.cdisc.org/standards/foundational/cdash. This will allow a standard way to collect data consistency across the Phase 2b clinical trials. This also ensures an easy submission to regulatory agencies (e.g. FDA) and efficient data analyses. |
| 8) |
The Sponsor is responsible to ensure medical case management during the trial, including the specific approach to care of participants with COVID-19. |
| 9)
|
Each Phase 2b clinical trial will obtain samples and data required for analysis of primary endpoint, secondary endpoints, and correlates of protection (COP) analysis1. The primary efficacy endpoint and certain secondary immunogenicity endpoints will be specified by BARDA. BARDA will provide an immune assay capability through a centralized network of laboratories that will perform the tests for the immunogenicity-related secondary endpoints on the specified number of samples for either COP or immunogenicity analyses. A sample analysis plan, including associated timelines for assay completion, will be developed through BARDA’s Centralized Laboratory Network, and will be approved by BARDA in consultation with the developer. Samples and data from Phase 2b trials are intended to be used in COP and cross-trial metanalyses; data will be shared with parties and published. Data analyses for immunogenicity, COP, and metanalysis based on assays provided through BARDA’s Centralized Laboratory Network (BCLN)2 will be conducted according to an SAP that is developed jointly by the vaccine developer and BARDA and approved by BARDA. |
|
a) |
Primary efficacy endpoint. The vaccine developer will be responsible for clinical assessment and assays (RT-PCR for virologically confirmed SARS-CoV-2) per the defined primary efficacy endpoint. The vaccine developer must share all clinical data with the USG in accordance with any requirements to ensure timely and complete transfer to the BARDA database resource. The BCLN will provide a resource for viral genomic sequencing of samples where SARS-CoV-2 infection was virologically confirmed with a positive RT-PCR result; these samples must be provided by the vaccine developer to the BARDA resource according to BARDA requirements. |
|
b) |
Immune assays. BARDA will be responsible for a minimum set of immunogenicity assays as defined herein. Immunogenicity assay data from the BCLN will constitute the secondary immunogenicity endpoint data. Immunogenicity assay data and analysis conducted by BARDA will be shared with the vaccine developer and released via publication. As our understanding of immunologic COPs and assay technology evolves in the near future, the approach described below may be modified to accommodate updated information. See item 10 for information on the number of subjects from which to collect samples. |
|
i) |
The minimal set of immunogenicity assays required for any trial includes assessment of sera samples by pseudovirus neutralization assay (PsVNA) and IgG binding antibody (bAb) assay; and peripheral blood mononuclear cells (PBMCs) by flow cytometry for intracellular cytokine and cell surface marker staining (ICS). |
|
ii) |
Any trial that includes a candidate administered via a mucosal route must include additional assays for assessment of: sera by IgA bAb assay; nasal samples by PsVNA, IgG bAb, and IgA bAb; and saliva samples by PsVNA, IgG bAb, and IgA bAb. Phase 2b trials that only include parenterally administered vaccines do not require these mucosal sample or IgA assays; however, these assays will be available at the request of the vaccine developer for testing at the partner’s expense. |
|
iii) |
Timepoints for immune assays will include samples collected at baseline (D1), day D31, D91, D181, and D366. Timepoints where BARDA-run assays will only be used for immunogenicity analysis will include D91 and D366 for all antibody assays and D91, D181 and 366 for testing of PBMCs by ICS; 200 randomly sampled subjects will be assessed for immunogenicity at each timepoint. Randomization requirements will be determined by BARDA. For requirements on timepoints for COP analysis see item 9c and for details for sample collection requirements, see item 10. |
1 Additional details for sample collection and processing protocols related to testing performed through the BARDA Central Laboratory Network (BCLN) including immune assays and virus sequencing are provided in the BARDA LAB SAMPLE PROCESSING GUIDANCE: Project Next Generation COVID-19 Phase 2B Vaccine Trials (Ver. 2.0)
2 BARDA has partnered with multiple organizations to establish the BARDA Central Laboratory Network (BCLN) to provide standardized immunological assay testing, sample storage and viral sequencing services to support the development of the next generation of COVID-19 vaccines (Project NextGen).
|
c) |
Correlates of Protection. Immune assays for COP analysis align with sample type and assay type requirements defined in item 9.b.i-ii. Timepoints and samples (for details on sample collection, see item 10) for COP analysis will include: baseline (D1) and D31 for sera, PBMCs*, nasal, and saliva samples and for sera only at D181. For mucosal sample COP, whether COP assays and analysis are run for mucosal samples, and on which mucosal sample type (either nasal or saliva, but not both) will be determined by BARDA based on the outcome of immunogenicity analysis (i.e., on 200 samples). Possibly 10% (roughly 1,000 samples based on a total Phase 2b enrollment target of 10,000) subjects will be assayed for COP analysis. BARDA will provide a centralized statistical and data coordinating center to conduct the COP analysis across all Phase 2b trials. Clinical data will be shared by BARDA’s Centralized Laboratory Network. The mix of sampled subjects and COP analysis will be defined in and conducted according to the SAP. The SAP will be developed in collaboration with and agreed to by BARDA. COP data analysis will be shared with the vaccine developer and released via publication. See item 10 for information on the number of subjects from which to collect samples. |
*Please note: if insufficient COVID-19 symptomatic cases (as defined per protocol primary endpoint) are identified in the PBMC collected samples to enable CoP analysis, BARDA may test 200 samples at all time points for immunogenicity assessment only.
|
d) |
Assays will be run with a minimum of three strains/variants, including (for example): |
|
i) |
Ancestral Wuhan strain |
|
ii) |
The currently recommended variant for COVID-19 vaccines (e.g., XBB 1.5 https://www.fda.gov/vaccines-blood-biologics/updated-covid-19-vaccines-use-united- states-beginning-fall- 2023#:~:text=Based%20on%20the%20totality%20of,a%20monovalent%20XBB%201.5%20co mposition) |
|
iii) |
A variant, to be determined by BARDA in consultation with the vaccine developer, based on the most prevalent circulating SARS-COV-2 strain/virus at the time and place of Phase 2b trial conduct. |
Assessment of any additional SARS-CoV-2 strains/variants will be decided by BARDA based on scientific justification, program priorities, and available funding. The vaccine developer may conduct their own independent additional assays with other SARS-CoV-2 variants; however, associated costs will be incurred by the vaccine developer.
|
10) |
Sample Draws for Immune Assays. Each Phase 2b trial will obtain samples required for testing in assays as defined under item 9. Samples from the trials will be used in assays for primary endpoint analysis, immunogenicity analysis, COP analyses, and metanalyses. Samples must be collected according to requirements defined by BARDA and, where required, must be delivered to the BARDA sample acquisition and storage resource. BARDA will share documentation that describes harmonized sample collection, processing, and storage procedures and requirements. Subject randomization and sample size for immunogenicity samples will occur according to the COP SAP, which will be determined by BARDA in coordination with the vaccine developer and finalized by BARDA. |
|
a) |
Blood samples. The vaccine developer must collect blood samples for the preparation of sera and PBMCs for immune assays. |
|
i) |
Sera. Sera samples must be collected from the total enrolled subjects at the baseline (D1), D31, and D181 timepoints; these timepoints will be used for COP analysis and must be collected from all subjects to ensure any future COVID-19 cases are captured. Sera samples must be collected from 200 randomly selected subjects at the D91 and D366 timepoints. A total sera volume of 4mL (8 mL of whole blood), in 8 x 0.5mL aliquots, must be collected from required subjects at the defined timepoints for the BARDA assays. Standard red-top tubes (i.e., contains no anticoagulant or preservative) should be used to collect sera samples. Additional sample volume for assays run by the industrial party should be accounted for in addition to the required volume for BARDA assays. Samples that will be shipped to the BARDA sample storage resource must be collected, aliquoted, stored, and shipped according to BARDA requirements. |
|
ii) |
PBMCs. PBMC samples should be collected from a minimum of 1000 subjects at baseline (D1) and D31; however, companies are encouraged to collect PBMC from at least 1667 and up to 2,000 subjects at these timepoints to maximize possibility of capturing enough COVID- 19 cases (as defined per protocol primary endpoint) for BARDA to conduct COP analysis. PBMCs must be collected from at least 200 randomly selected subjects at the D91, D181, and D366 timepoints. A total of 15x106 PBMCs, in three aliquots each of 5x106 PBMCs, must be collected from required subjects at the defined timepoints for the BARDA assays. Additional sample volume for assays run by the industrial party should be accounted for in addition to the required volume for BARDA assays. Samples that will be shipped to the BARDA sample storage resource must be collected, stored, and shipped according to BARDA requirements. PBMCs must be collected according to the Standard Operating Procedure: Peripheral Blood Mononuclear Cells (PBMC) and Associated Plasma Collection (No.: DMID- OCRR-SOP-002; Effective Date: 30-SEP-2021), BARDA preference is the option that defines the protocol specific to collection using Cellular Preparation Tubes (CPTs). |
|
b) |
Mucosal samples. The vaccine developer must collect nasal and saliva samples if required by BARDA or requested by the vaccine developer per item 9.b.ii. Both nasal and saliva samples must be collected from the total enrolled subjects at the baseline (D1), D31, and D181 timepoints; these timepoints will be used for COP analysis and must be collected from all subjects to ensure any future COVID-19 cases are captured. Nasal and saliva samples must be collected from 200 randomly selected subjects at the D91 and D366 timepoints. Nasal samples must be collected using the Nasosorption device and saliva samples much be collected using the Oracol device. Samples must be collected per the device instructions for use and specific collection procedure requirements as defined by BARDA; Nasal samples must be diluted up to a final volume of 1mL with 1X Mucosal Buffer and divided into four aliquots of 0.25mL. Saliva samples will be diluted at a 1:1 ratio with 2x Mucosal Buffer for a final volume of 1 ml and aliquoted into four x 0.25 mL aliquots. Additional sample volume for assays run by the industrial party should be accounted for in addition to the required volume for BARDA assays. Samples that will be shipped to the BARDA sample storage resource must be collected, stored, and shipped according to BARDA requirements. |
|
c) |
Informed Consent. The clinical trial informed consent developed by the vaccine developer or CSN partner must capture how clinical immune samples collected during the study will be used – both for per protocol use and future non-per protocol use. Long term storage of these samples will occur at the BARDA Biological Specimen and Investigational Product storage facility (BSIP). |
Exhibit 31.1
CERTIFICATION
PURSUANT TO RULE 13a-14(a) or 15d-14(a)
OF THE
SECURITIES EXCHANGE ACT OF 1934
I, David A. Dodd, President and Chief Executive Officer of GeoVax Labs, Inc. certify that:
|
(1) |
I have reviewed this quarterly report on Form 10-Q of GeoVax Labs, 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 controls 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 registrant’s board of directors (or persons performing the equivalent functions): |
|
a. |
All significant deficiencies or 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. |
|
Dated: August 6, 2024 |
/s/ David A. Dodd David A. Dodd President & Chief Executive Officer |
|
Exhibit 31.2
CERTIFICATION
PURSUANT TO RULE 13a-14(a) or 15d-14(a)
OF THE
SECURITIES EXCHANGE ACT OF 1934
I, Mark W. Reynolds, Chief Financial Officer of GeoVax Labs, Inc. certify that:
|
(1) |
I have reviewed this quarterly report on Form 10-Q of GeoVax Labs, 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 controls 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 registrant’s board of directors (or persons performing the equivalent functions): |
|
a. |
All significant deficiencies or 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. |
| Dated: August 6, 2024 |
/s/ Mark W. Reynolds Mark W. Reynolds Chief Financial Officer |
Exhibit 32.1
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
In connection with the quarterly report of GeoVax Labs, Inc. (the "Company") on Form 10-Q for the three months ended June 30, 2024, I, David A. Dodd, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes - Oxley Act of 2002, that to the best of my knowledge:
1. The quarterly report fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934; and
2. The information contained in the quarterly report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| Dated: August 6, 2024 |
/s/ David A. Dodd David A. Dodd President & Chief Executive Officer |
Exhibit 32.2
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
In connection with the quarterly report of GeoVax Labs, Inc. (the "Company") on Form 10-Q for the three months ended June 30, 2024, I, Mark W. Reynolds, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes - Oxley Act of 2002, that to the best of my knowledge:
1. The quarterly report fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934; and
2. The information contained in the annual report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| Dated: August 6, 2024 |
/s/ Mark W. Reynolds Mark W. Reynolds Chief Financial Officer |