10-Q
Black Diamond Therapeutics, Inc. (BDTX)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
___________________________________________
FORM 10-Q
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| ☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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FOR THE QUARTERLY PERIOD ENDED March 31, 2025
OR
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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FOR THE TRANSITION PERIOD FROM _ TO _
COMMISSION FILE NUMBER 001-38501
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BLACK DIAMOND THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
________________________________________________________________________________
| Delaware | 81-4254660 |
|---|---|
| (State or other jurisdiction<br><br>of incorporation or organization) | (I.R.S. Employer<br><br>Identification No.) |
| One Main Street, 14th Floor<br><br>Cambridge, Massachusetts<br><br>(Address of principal executive offices) | 02142<br><br>(Zip Code) |
| (617) 252-0848<br><br>(Registrant’s telephone number, including area code) | |
| Not Applicable<br><br>(Former name, former address and former fiscal year, if changed since last report) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common stock, par value $0.0001 | BDTX | The Nasdaq Global Select Market |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
|---|---|---|---|
| Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
| Emerging growth company | ☒ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of May 6, 2025, the registrant had 56,862,635 shares of common stock, $0.0001 par value per share, outstanding.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (this Quarterly Report) contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “could”, “should”, “expects”, “intends”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, “continue” or the negative of these terms or other comparable terminology. These statements are not guarantees of future results or performance and involve substantial risks and uncertainties. Forward-looking statements in this Quarterly Report include, but are not limited to, statements about:
•the progress, timing and success of our clinical trials of BDTX-1535 and any of our future product candidates, including the availability, timing and announcement of data and results of such trials;
•our ability to obtain and maintain regulatory approval for BDTX-1535 or any of our future product candidates that we may identify or develop;
•the scope, timing, progress and results of our clinical trials and investigational new drug (IND) applications, development efforts and other regulatory submissions;
•the effects of competition with respect to BDTX-1535 or any of our other current or future product candidates, as well as innovations by current and future competitors in our industry;
•our partnership with Servier Pharmaceuticals LLC (Servier) and the intended and potential benefits thereof, including the receipt of potential milestone and royalty payments from commercial product sales, along with tiered royalties based on global net sales, if any;
•Servier’s ability to develop and commercialize BDTX-4933, including the ongoing Phase 1 clinical trial of BDTX-4933, and the potential of BDTX-4933 to address the unmet medical need for patients with RAF/RAS-mutant solid tumors, including non-small cell lung cancer (NSCLC);
•our evaluation of strategic alternatives for BDTX-4876, including our ability to execute and realize the anticipated benefits of any strategic alternatives we may pursue;
•the impact of our restructuring plan and the expected cost savings from the restructuring;
•our need to raise additional funding before we can expect to generate any revenues from product sales;
•our ability to develop our current and future product candidates for the treatment of various cancers;
•the rate and degree of market acceptance and clinical utility for any current or future product candidates we may develop;
•the implementation of our strategic plans for our business and our product candidates;
•our ability to successfully develop companion diagnostics for use with our current or future product candidates;
•our intellectual property position, including the scope of protection we are able to establish, maintain and enforce for intellectual property rights covering our product candidates and Mutation-Allostery-Pharmacology (MAP) drug discovery engine;
•our ability to obtain additional funding for our operations, when needed, including funding necessary to complete further development and commercialization of our product candidates, if approved;
•the period over which we expect our existing cash, cash equivalents and investments will be sufficient to fund our operating expenses and capital expenditure requirements;
•the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
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•our future financial performance and our ability to effectively manage our anticipated growth;
•our estimates regarding the market opportunities for our product candidates, including our competitive position and the success of competing therapies that are or may become available;
•our need for and ability to attract and retain key scientific, management and other personnel and to identify, hire and retain additional qualified professionals;
•the potential for our business development efforts to maximize the value of our product candidates;
•the size and growth potential of the markets for our product candidates, and our ability to serve those markets, either alone or in partnership with others;
•our ability to establish or maintain collaborations or strategic relationships and the ability and willingness of our third-party strategic collaborators to undertake research and development activities relating to our current or future product candidates;
•our expectations regarding the period during which we will remain an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (the JOBS Act);
•our ability to maintain an effective system of internal controls; and
•the impact of macroeconomic and geopolitical developments on our business, including rising inflation and capital market disruptions, changes in U.S. governmental agencies, new or increased international tariffs and retaliatory tariffs, trade protection measures, economic sanctions and economic slowdowns or recessions that may result from such developments which could harm our research and development efforts as well as the value of our common stock and our ability to access capital markets.
Any forward-looking statements in this Quarterly Report reflect our current views with respect to future events and with respect to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those described under Part I, Item 1A, “Risk Factors” and elsewhere in our most recent Annual Report on Form 10-K for the year ended December 31, 2024 (the Annual Report) and in other Securities and Exchange Commission (SEC) filings. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
All of our forward-looking statements are as of the date of this Quarterly Report only. In each case, actual results may differ materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence of or any material adverse change in one or more of the risk factors or risks and uncertainties referred to in this Quarterly Report or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the SEC, could materially and adversely affect our business, prospects, financial condition and results of operations. Some of these risks and uncertainties may in the future be amplified by global health crises, macroeconomic conditions and geopolitical developments, and there may be additional risks that we consider immaterial or which are unknown. It is not possible to predict or identify all such risks. Except as required by law, we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us following this Quarterly Report that modify or impact any of the forward-looking statements contained in this Quarterly Report will be deemed to modify or supersede such statements in this Quarterly Report.
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This Quarterly Report contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed as exhibits to this Quarterly Report. In this Quarterly Report, the terms “Black Diamond Therapeutics”, “Black Diamond”, the “Company”, “we”, “us”, “our” and similar designations refer to Black Diamond Therapeutics, Inc. and, where appropriate, our wholly-owned subsidiary.
We may from time to time provide estimates, projections and other information concerning our industry, the general business environment, and the markets for certain diseases, including estimates regarding the potential size of those markets and the estimated incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events, circumstances or numbers, including actual disease prevalence rates and market size, may differ materially from the information reflected in this Quarterly Report. Unless otherwise expressly stated, we obtained this industry, business information, market data, prevalence information and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources, in some cases applying our own assumptions and analysis that may, in the future, prove not to have been accurate.
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| Page | |
|---|---|
| PART I - FINANCIAL INFORMATION | 6 |
| Item 1. Condensed Consolidated Financial Statements (Unaudited) | 6 |
| Condensed Consolidated Balance Sheets | 6 |
| Condensed Consolidated Statements of Operations and ComprehensiveIncome (Loss) | 7 |
| Condensed Consolidated Statements of Cash Flows | 8 |
| Condensed Consolidated Statements of Stockholders’ Equity | 9 |
| Notes to Unaudited Condensed Consolidated Financial Statements | 10 |
| Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations | 24 |
| Item 3. Quantitative and Qualitative Disclosures about Market Risk | 35 |
| Item 4. Controls and Procedures | 35 |
| PART II - OTHER INFORMATION | 36 |
| Item 1. Legal Proceedings | 36 |
| Item 1A. Risk Factors | 36 |
| Item 2. Unregistered Sales of Equity SecuritiesandUse of Proceeds | 39 |
| Item 3. Defaults Upon Senior Securities | 39 |
| Item 4. Mine Safety Disclosures | 40 |
| Item 5. Other Information | 40 |
| Item 6. Exhibits | 41 |
| SIGNATURES | 42 |
We have applied for various trademarks that we use in connection with the operation of our business. This Quarterly Report may also contain trademarks, service marks and trade names of third parties, which are the property of their respective owners. Our use or display of third parties’ trademarks, service marks, trade names or products in this Quarterly Report is not intended to, and does not, imply a relationship with, or endorsement or sponsorship by, us. Solely for convenience, the trademarks, service marks and trade names referred to in this Quarterly Report may appear without the ®, TM or SM symbols, but the omission of such references is not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner of these trademarks, service marks and trade names will not assert, to the fullest extent under applicable law, its rights.
From time to time, we may use our website or our LinkedIn profile at www.linkedin.com/company/black-diamond-therapeutics to distribute material information. Our financial and other material information is routinely posted to and accessible on the Investors section of our website, available at www.blackdiamondtherapeutics.com. Investors are encouraged to review the Investors section of our website because we may post material information on that site that is not otherwise disseminated by us. Information that is contained in and can be accessed through our website or our LinkedIn page is not incorporated into, and does not form a part of, this Quarterly Report.
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Part I - FINANCIAL INFORMATION
Item I. Condensed Consolidated Financial Statements (Unaudited)
Black Diamond Therapeutics, Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands, except share and per share data)
| As of | ||||
|---|---|---|---|---|
| March 31,<br>2025 | December 31,<br>2024 | |||
| Assets | ||||
| Current assets: | ||||
| Cash and cash equivalents | $ | 98,424 | $ | 36,437 |
| Investments | 53,976 | 62,138 | ||
| Prepaid expenses and other current assets | 3,279 | 2,601 | ||
| Total current assets | 155,679 | 101,176 | ||
| Property and equipment, net | 1,300 | 1,387 | ||
| Restricted cash | 821 | 819 | ||
| Right-of-use assets | 18,240 | 19,009 | ||
| Other non-current assets | 205 | 249 | ||
| Total assets | $ | 176,245 | $ | 122,640 |
| Liabilities and Stockholders' Equity | ||||
| Current liabilities: | ||||
| Accounts payable | $ | 2,628 | $ | 4,007 |
| Accrued expenses and other current liabilities | 14,219 | 16,566 | ||
| Total current liabilities | 16,847 | 20,573 | ||
| Non-current operating lease liabilities | 17,882 | 18,782 | ||
| Total liabilities | 34,729 | 39,355 | ||
| Commitments and contingencies (Note 11) | ||||
| Stockholders' equity: | ||||
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized at March 31, 2025 and December 31, 2024; no shares issued or outstanding at March 31, 2025 and December 31, 2024 | — | — | ||
| Common stock; $0.0001 par value; 500,000,000 shares authorized at March 31, 2025 and December 31, 2024; 56,676,716 shares issued and outstanding at March 31, 2025 and 56,644,655 shares issued and outstanding at December 31, 2024 | 7 | 7 | ||
| Additional paid-in capital | 572,093 | 570,361 | ||
| Accumulated other comprehensive (loss) income | (19) | 24 | ||
| Accumulated deficit | (430,565) | (487,107) | ||
| Total stockholders' equity | 141,516 | 83,285 | ||
| Total liabilities and stockholders' equity | $ | 176,245 | $ | 122,640 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Black Diamond Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited)
(in thousands, except share and per share data)
| Three Months Ended<br>March 31, | ||||
|---|---|---|---|---|
| 2025 | 2024 | |||
| License revenue | $ | 70,000 | $ | — |
| Operating expenses: | ||||
| Research and development | $ | 10,506 | $ | 13,545 |
| General and administrative | 4,964 | 6,701 | ||
| Total operating expenses | 15,470 | 20,246 | ||
| Income (loss) from operations | 54,530 | (20,246) | ||
| Other income (expense): | ||||
| Interest income | 595 | 637 | ||
| Other income (expense) | 1,417 | 1,384 | ||
| Total other income (expense), net | 2,012 | 2,021 | ||
| Net income (loss) | $ | 56,542 | $ | (18,225) |
| Net income (loss) per share - basic | $ | 1.00 | $ | (0.35) |
| Net income (loss) per share - diluted | $ | 0.98 | $ | (0.35) |
| Weighted average common shares outstanding - basic | 56,663,798 | 51,808,849 | ||
| Weighted average common shares outstanding - diluted | 57,673,099 | 51,808,849 | ||
| Comprehensive income (loss): | ||||
| Net income (loss) | $ | 56,542 | $ | (18,225) |
| Other comprehensive income (loss): | ||||
| Unrealized gain (loss) on investments, net | (43) | (68) | ||
| Comprehensive income (loss) | $ | 56,499 | $ | (18,293) |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Black Diamond Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows (Unaudited)
(in thousands)
| Three Months Ended<br>March 31, | ||||
|---|---|---|---|---|
| 2025 | 2024 | |||
| Cash flows from operating activities: | ||||
| Net income (loss) | $ | 56,542 | $ | (18,225) |
| Adjustment to reconcile net income (loss) to net cash used in operating activities: | ||||
| Stock-based compensation expense | 1,700 | 1,713 | ||
| Depreciation expense | 87 | 86 | ||
| (Accretion) amortization on investments | (415) | (932) | ||
| Noncash rent expense | 769 | 728 | ||
| (Gain) Loss on sale of equipment | (13) | — | ||
| Changes in current assets and liabilities: | ||||
| Prepaid expenses and other current assets | (678) | (973) | ||
| Other non-current assets | 44 | — | ||
| Accounts payable | (1,379) | (1,128) | ||
| Accrued expenses and other current liabilities | (2,347) | (1,644) | ||
| Non-current operating lease liabilities | (900) | (824) | ||
| Net cash provided by (used in) operating activities | 53,410 | (21,199) | ||
| Cash flows from investing activities: | ||||
| Proceeds from sale of equipment | 13 | — | ||
| Proceeds from sales and maturities of investments | 32,000 | 38,500 | ||
| Purchases of investments | (23,466) | (52,234) | ||
| Net cash provided by (used in) by investing activities | 8,547 | (13,734) | ||
| Cash flows from financing activities: | ||||
| Proceeds from exercise of common stock options and ESPP | 32 | 150 | ||
| Proceeds from issuance of common stock, net of issuance costs | — | 3,980 | ||
| Net cash provided by financing activities | 32 | 4,130 | ||
| Net (decrease) increase in cash and cash equivalents | 61,989 | (30,803) | ||
| Cash, cash equivalents and restricted cash, beginning of period | 37,256 | 57,044 | ||
| Cash, cash equivalents and restricted cash, end of period | $ | 99,245 | $ | 26,241 |
| Cash and cash equivalents, end of period | $ | 98,424 | $ | 25,422 |
| Restricted cash, end of period | 821 | 819 | ||
| Cash, cash equivalents and restricted cash, end of period | $ | 99,245 | $ | 26,241 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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| Black Diamond Therapeutics, Inc.<br><br>Condensed Consolidated Statements of Stockholders' Equity (Unaudited)<br><br>(in thousands, except share data) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Common stock | Additional<br><br>paid-in capital | Accumulated other comprehensive income (loss) | Accumulated deficit | Total<br><br>stockholders’<br><br>equity | |||||||
| Shares | Par Value | ||||||||||
| BALANCE - December 31, 2023 | 51,645,557 | $ | 7 | $ | 534,187 | $ | (27) | $ | (417,431) | $ | 116,736 |
| Issuance of common stock, net of issuance costs | 800,000 | — | 4,000 | — | — | 4,000 | |||||
| Exercise of common stock options | 47,741 | — | 86 | — | — | 86 | |||||
| Vesting of restricted stock units | 1,250 | — | — | — | — | — | |||||
| Issuance of common stock related to ESPP | 26,659 | — | 64 | — | — | 64 | |||||
| Stock-based compensation | 6,419 | — | 1,713 | — | — | 1,713 | |||||
| Unrealized gain (loss) on investments | — | — | — | (68) | — | (68) | |||||
| Net loss | — | — | — | — | (18,225) | (18,225) | |||||
| BALANCE - March 31, 2024 | 52,527,626 | 7 | 540,050 | (95) | (435,656) | 104,306 | |||||
| BALANCE - December 31, 2024 | 56,644,655 | $ | 7 | $ | 570,361 | $ | 24 | $ | (487,107) | $ | 83,285 |
| Issuance of common stock related to ESPP | 17,567 | — | 32 | — | — | 32 | |||||
| Stock-based compensation | 14,494 | — | 1,700 | — | — | 1,700 | |||||
| Unrealized gain (loss) on investments | — | — | — | (43) | — | (43) | |||||
| Net loss | — | — | — | — | 56,542 | 56,542 | |||||
| BALANCE - March 31, 2025 | 56,676,716 | $ | 7 | $ | 572,093 | $ | (19) | $ | (430,565) | $ | 141,516 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Black Diamond Therapeutics, Inc.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
(Amounts in thousands, except share and per share amounts)
1. NATURE OF BUSINESS AND BASIS OF PRESENTATION
Black Diamond Therapeutics, Inc. (the Company) is a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer. The Company was originally organized as a limited liability company in December 2014 under the name ASET Therapeutics LLC. In September 2016, the Company was converted to a corporation under the laws of the State of Delaware under the name ASET Therapeutics, Inc. The Company changed its name to Black Diamond Therapeutics, Inc. in January 2018. Since its inception, the Company has devoted substantially all of its efforts to raising capital, obtaining financing and incurring research and development costs related to the development and advancement of its product candidates identified by its Mutation-Allostery-Pharmacology (MAP) drug discovery engine.
The Company is subject to risks and uncertainties common to clinical-stage companies in the biotechnology industry. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s technology will be obtained, that any products developed will obtain necessary government regulatory approval or that any products, if approved, will be commercially viable. The Company operates in an environment of rapid technological innovation and substantial competition from pharmaceutical and biotechnological companies. In addition, the Company is dependent upon the services of its employees, consultants and service providers. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
On March 18, 2025, the Company entered into a global licensing agreement (the Servier Agreement) with Servier Pharmaceuticals LLC (Servier) for BDTX-4933, a small molecule designed by the Company to address unmet medical needs in RAF/RAS-mutant solid tumors, pursuant to which the Company granted to Servier a worldwide license to develop and commercialize BDTX-4933. Under the terms of the Servier Agreement, Servier will lead the development activities and the worldwide commercialization of BDTX-4933 across multiple indications, including non-small cell lung cancer (NSCLC), with potential applications in other solid tumors. Under the Servier Agreement, the Company received an upfront payment of $70.0 million in March 2025 and will be eligible to receive up to $710.0 million in development and commercial sales milestone payments, along with tiered royalties based on global net sales. The Servier Agreement is discussed in greater detail in Note 14, License Revenue.
The accompanying condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets, and the satisfaction of liabilities and commitments in the ordinary course of business. Historically, the Company has funded its operations primarily with proceeds from the sale of common stock and preferred stock, and through the $70.0 million upfront payment received under the Servier Agreement in March 2025. The Company has had recurring losses and negative cash flows from operations in all periods since inception, except for net income of $56.5 million for the three months ended March 31, 2025, reflecting revenue recognized under the Servier Agreement. The Company had an accumulated deficit of $430.6 million as of March 31, 2025. The Company expects to continue to generate operating losses for the foreseeable future.
As of May 12, 2025, the issuance date of the condensed consolidated financial statements, the Company expects that its cash, cash equivalents and investments will be sufficient to fund its currently planned operations for at least the next 12 months from the filing date of these condensed consolidated financial statements.
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The Company will seek additional funding through private or public equity financings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. The Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into collaborations or other arrangements. The terms of any financing may adversely affect the holdings or the rights of the Company's stockholders. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or commercialization efforts, or reduce headcount and general and administrative costs, which could adversely affect its business prospects. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The following is a summary of significant accounting policies followed in the preparation of these condensed consolidated financial statements.
Principles of consolidation
The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) and include the accounts of the Company and its wholly owned subsidiary, Black Diamond Therapeutics Security Corporation, after elimination of all significant intercompany accounts and transactions.
Unaudited interim financial information
The condensed consolidated financial statements of the Company included herein have been prepared, without audit, pursuant to the rules and regulations of the SEC. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this Quarterly Report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. In the opinion of the Company’s management, all adjustments (consisting of normal and recurring adjustments) considered necessary for a fair statement of the results for the interim periods presented have been included.
Use of estimates
The preparation of the Company’s condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the accrual of research and development expenses and the valuation of stock-based awards. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results may differ from those estimates or assumptions.
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The Company continues to monitor the impact of macroeconomic developments and geopolitical developments, including political unrest, international tariffs, economic sanctions and economic slowdowns or recessions, high inflation, disruptions in capital markets, changes in U.S. governmental agencies, international trade relationships and military conflicts, and health crises, on all aspects of its business, and has considered the impact of these factors on estimates within its financial statements. The extent to which future developments may impact the Company’s business, results of operations or financial condition are uncertain and cannot be predicted with confidence and there may be changes to estimates in future periods. As of the date of issuance of these condensed consolidated financial statements, the Company has not experienced material business disruptions or incurred impairment losses in the carrying value of its assets as a result of these factors and is not aware of any specific related event or circumstance that would require it to update its estimates.
Revenue Recognition
The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers, (ASC 606). This standard applies to all contracts with customers, except for contracts that are within the scope of other standards. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services.
The Company enters into licensing agreements with partners under which it may exclusively license rights to research, develop, manufacture, and commercialize product candidates to third parties. The terms of these arrangements may include payment to the Company of one or more of the following: (1) non-refundable, upfront fees; (2) reimbursement of certain costs; (3) customer option fees for additional goods or services; (4) milestone payments; and (5) royalties on net sales of licensed products.
In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. As part of the accounting for these arrangements, the Company must use its judgment to determine: (a) the number of performance obligations based on the determination under step (ii) above; (b) the transaction price under step (iii) above; (c) the stand-alone selling price for each performance obligation identified in the contract for the allocation of transaction price in step (iv) above; and (d) the contract term and pattern of satisfaction of the performance obligations under step (v) above. The Company also uses judgment to determine whether milestones or other variable consideration, except for royalties, should be included in the transaction price as described further below. The transaction price is allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Amounts due to the Company for satisfying the revenue recognition criteria or that are contractually due based upon the terms of the applicable agreement are recorded as a receivable in the Company’s consolidated balance sheet.
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Milestone payments
The Company measures the transaction price based on the amount of consideration to which the Company expects to be entitled in exchange for transferring the promised goods and/or services to the customer. At the inception of an arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount of variable consideration to be included in the transaction price utilizing either the expected value method or the most likely amount method, depending on which method is expected to better predict the amount of consideration to which the Company will be entitled. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved.
With respect to arrangements that include payments for a development or regulatory milestone, the Company evaluates whether the associated event is considered likely of achievement and estimates the amount to be included in the transaction price using the most likely amount method. Milestone payments that are not within the Company’s control or the control of the counterparty, such as those dependent upon receipt of regulatory approval, are not considered to be likely of achievement until the triggering event occurs. At the end of each reporting period, the Company re-evaluates the probability of achievement of each milestone and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net income (loss) in the period of adjustment. See Note 14 to our condensed consolidated financial statements for additional information on the Company’s license revenue.
For arrangements that include sales-based royalties, including milestone payments based upon the achievement of a certain level of product sales, wherein the license is deemed to be the sole or predominant item to which the payments relate, the Company recognizes revenue upon the later of: (i) when the related sales occur or (ii) when the performance obligation to which some or all of the payment has been allocated has been satisfied (or partially satisfied). Consideration that would be received for optional goods and/or services is excluded from the transaction price at contract inception.
Recently issued accounting pronouncements
In November 2024, the FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which is intended to enhance transparency into the nature and function of expenses. The amendments require that on an annual and interim basis, entities disclose disaggregated operating expense information about specific categories, including purchases of inventory, employee compensation, depreciation, amortization and depletion. This guidance is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. The Company will evaluate the impact of the guidance on its financial statements in advance of the adoption date.
In December 2023, the FASB issued ASU, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09). ASU 2023-09 requires that public business entities on an annual basis (1) disclose specific categories in the rate reconciliation and (2) provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5 percent of the amount computed by multiplying pretax income (or loss) by the applicable statutory income tax rate). The standard is effective for annual periods beginning after December 15, 2024. Adoption of the standard requires certain changes to be made prospectively, with some changes to be made retrospectively. The adoption is not expected to have a material impact on the Company’s consolidated financial statements.
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3. FAIR VALUE MEASUREMENTS
The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy used to determine such fair values:
| Fair value measurements at March 31, 2025 using: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Total | |||||
| Assets: | ||||||||
| Cash equivalents: | ||||||||
| Money market funds | $ | 97,334 | $ | — | $ | — | $ | 97,334 |
| Investments: | ||||||||
| Commercial paper | — | 35,675 | — | 35,675 | ||||
| Corporate bonds | — | 18,301 | — | 18,301 | ||||
| Total | $ | 97,334 | $ | 53,976 | $ | — | $ | 151,310 |
| Fair value measurements at December 31, 2024 using: | ||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Level 1 | Level 2 | Level 3 | Total | |||||
| Assets: | ||||||||
| Cash equivalents: | ||||||||
| Money market funds | $ | 35,345 | $ | — | $ | — | $ | 35,345 |
| Investments: | ||||||||
| Commercial paper | — | 34,914 | — | 34,914 | ||||
| Corporate bonds | — | 27,224 | — | 27,224 | ||||
| Total | $ | 35,345 | $ | 62,138 | $ | — | $ | 97,483 |
When developing fair value estimates, the Company maximizes the use of observable inputs and minimizes the use of unobservable inputs. When available, the Company uses quoted market prices to measure fair value. The valuation technique used to measure fair value for the Company's Level 1 and Level 2 assets is a market approach, using prices and other relevant information generated by market transactions involving identical or comparable assets. If market prices are not available, the fair value measurement is based on models that use primarily market-based parameters including yield curves, volatilities, credit ratings and currency rates. In certain cases where market rate assumptions are not available, the Company is required to make judgments about assumptions market participants would use to estimate the fair value of a financial instrument.
There were no transfers in or out of Level 3 categories in the periods presented.
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4. INVESTMENTS
As of March 31, 2025, investments were comprised of the following:
| Amortized Cost | Unrealized Gains | Unrealized Losses | Fair Value | |||||
|---|---|---|---|---|---|---|---|---|
| Commercial paper | $ | 35,689 | $ | 2 | $ | (16) | $ | 35,675 |
| Corporate bonds | 18,306 | 2 | (7) | 18,301 | ||||
| Total | $ | 53,995 | $ | 4 | $ | (23) | $ | 53,976 |
As of December 31, 2024, investments were comprised of the following:
| Amortized Cost | Unrealized Gains | Unrealized Losses | Fair Value | |||||
|---|---|---|---|---|---|---|---|---|
| Commercial paper | $ | 34,900 | $ | 19 | $ | (5) | $ | 34,914 |
| Corporate bonds | 27,214 | 24 | (14) | 27,224 | ||||
| Total | $ | 62,114 | $ | 43 | $ | (19) | $ | 62,138 |
As of March 31, 2025, all marketable securities held by the Company had remaining contractual maturities of one year or less.
As of December 31, 2024, all marketable securities held by the Company had remaining contractual maturities of one year or less.
As of March 31, 2025, the Company reviewed its investment portfolio to assess the unrealized losses on its available-for-sale investments. The Company evaluated whether it intended to sell the security and whether it was more likely than not that the Company would be required to sell the security before recovering its amortized cost basis. The Company also determined no portion of the unrealized losses relate to a credit loss. There have been no impairments of the Company’s assets measured and carried at fair value during the three months ended March 31, 2025 and the year ended December 31, 2024.
5. PROPERTY AND EQUIPMENT
Property and equipment, net consisted of the following:
| March 31,<br>2025 | December 31,<br>2024 | |||
|---|---|---|---|---|
| Furniture and fixtures | $ | 17 | $ | 17 |
| Leasehold improvements | 2,512 | 2,512 | ||
| Property and equipment | 2,529 | 2,529 | ||
| Less: accumulated depreciation | (1,229) | (1,142) | ||
| Total Property and Equipment, net | $ | 1,300 | $ | 1,387 |
Depreciation expense for the three months ended March 31, 2025 and 2024 was $87 and $86, respectively.
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6. EQUITY METHOD INVESTMENT
In December 2022, the Company received 9,000,000 shares of common stock in a newly formed antibody-focused precision oncology company, Revelio Therapeutics, Inc. (Revelio) (formerly known as Launchpad Therapeutics, Inc.), in exchange for contributing early discovery-stage antibody programs and granting Revelio a license to use its MAP drug discovery engine to discover, develop and commercialize large molecule therapeutics. As of December 31, 2024 and March 31, 2025, the Company had a voting interest in Revelio of 20.8% and 15.1%, respectively, and one seat on Revelio’s Board of Directors, which provide the Company with significant influence over Revelio. Other investors in Revelio include Versant Ventures and New Enterprise Associates (NEA), who are shareholders of the Company.
The Company accounted for the transaction under the equity method. As of March 31, 2025 and the year ended December 31, 2024, the carrying value of the investment in Revelio was zero. Since the Company has no obligation to provide financing support to Revelio, the Company is not required to record further losses exceeding the carrying value of the investment. The Company also determined that its investment in Revelio is not material or significant to its operations or financial position.
7. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
Accrued expenses and other current liabilities consisted of the following:
| March 31,<br>2025 | December 31,<br>2024 | |||
|---|---|---|---|---|
| Contracted research services | $ | 7,879 | $ | 8,226 |
| Payroll and related expenses | 2,024 | 4,373 | ||
| Professional and consulting fees | 611 | 563 | ||
| Current portion of operating lease liability and other | 3,705 | 3,404 | ||
| Total accrued expenses and other current liabilities | $ | 14,219 | $ | 16,566 |
8. STOCK-BASED COMPENSATION
2020 Stock Option and Incentive Plan
The 2020 Stock Option and Incentive Plan (the 2020 Plan) was approved by the Company’s board of directors on December 5, 2019, and the Company’s stockholders on January 14, 2020 and became effective on the date immediately prior to the date on which the registration statement for the Company’s initial public offering (IPO) was declared effective. The 2020 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock units, restricted stock awards, unrestricted stock awards, cash-based awards and dividend equivalent rights to the Company’s officers, employees, directors and consultants. The 2020 Plan provides for an annual increase, to be added on the first day of each fiscal year, by up to 4% of the Company’s outstanding shares of common stock as of the last day of the prior year. On January 1, 2025, 2,265,786 shares of common stock, representing 4% of the Company’s outstanding shares of common stock as of December 31, 2024, were added to the 2020 Plan.
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2020 Employee Stock Purchase Plan
The 2020 Employee Stock Purchase Plan (the 2020 ESPP) was approved by the Company’s board of directors on December 5, 2019, and the Company’s stockholders on January 14, 2020, and became effective on the date immediately prior to the date on which the registration statement for the Company’s IPO was declared effective. The 2020 ESPP provides for an annual increase, to be added on the first day of each fiscal year, by up to 1% of the number of shares of the Company’s common stock outstanding on the immediately preceding December 31. The number of authorized shares reserved for issuance under the 2020 ESPP was increased by 326,364 shares effective as of January 1, 2025.
Stock-based compensation expense
The Company recorded stock-based compensation expense in the following award type categories included within the condensed consolidated statements of operations and comprehensive loss:
| Three Months Ended<br>March 31, | |||||
|---|---|---|---|---|---|
| 2025 | 2024 | ||||
| Stock options | $ | 1,141 | $ | 1,623 | |
| Restricted stock units | 529 | 16 | |||
| Employee Stock Purchase Plan and Other | 30 | 74 | |||
| $ | 1,700 | $ | 1,713 |
For the three months ended March 31, 2025, the Company issued 14,494 shares of common stock under its 2020 Plan in accordance with its policy where non-employee directors may elect to receive their compensation in the form of common stock in lieu of cash.
The Company recorded stock-based compensation expense in the following expense categories of its condensed consolidated statements of operations and comprehensive loss:
| Three Months Ended<br>March 31, | |||||
|---|---|---|---|---|---|
| 2025 | 2024 | ||||
| Research and development | $ | 781 | $ | 635 | |
| General and administrative | 919 | 1,078 | |||
| $ | 1,700 | $ | 1,713 |
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Options
The following table summarizes the stock option activity under the Company’s equity awards plans:
| Options | Weighted<br><br>Average<br><br>Exercise<br><br>Price | Weighted<br><br>Average<br><br>Remaining<br><br>Life<br><br>(in Years) | Intrinsic<br><br>Value<br><br>(in thousands) | |||
|---|---|---|---|---|---|---|
| Outstanding December 31, 2024 | 9,434,742 | $ | 7.48 | 6.6 | $ | 313 |
| Granted | 1,793,300 | $ | 2.52 | |||
| Cancelled or forfeited | (281,396) | $ | 11.52 | |||
| Expired | (106,805) | $ | 16.10 | |||
| Outstanding March 31, 2025 | 10,839,841 | $ | 6.47 | 7.2 | $ | 14 |
| Options vested or expected to vest at March 31, 2025 | 10,839,841 | $ | 6.47 | 7.2 | $ | 14 |
| Options exercisable at March 31, 2025 | 5,701,054 | $ | 9.22 | 5.6 | $ | 14 |
For the three months ended March 31, 2025, total unrecognized compensation cost related to the unvested stock-options was $11,649, which is expected to be recognized over a weighted average period of 2.8 years.
Restricted stock units
The fair values of restricted stock units are based on the market value of the Company’s stock on the date of the grant. Under terms of the time-based restricted stock agreements covering the common stock, shares of restricted common stock are subject to a vesting schedule. The following table summarizes time-based restricted stock activity since January 1, 2025:
| Number of<br><br>shares | Weighted<br><br>average<br><br>grant date<br><br>fair value | ||
|---|---|---|---|
| Unvested restricted common stock as of December 31, 2024 | 540,000 | $ | 3.66 |
| Granted | 450,000 | $ | 2.52 |
| Unvested restricted common stock as of March 31, 2025 | 990,000 | $ | 3.14 |
During the three months ended March 31, 2025 no time-based restricted stock units vested, therefore there was no expense booked.
For the three months ended March 31, 2025, there was $2,167 unrecognized compensation cost related to the time-based unvested restricted stock units.
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9. NET INCOME (LOSS) PER SHARE
Net income (loss) per share
We compute basic net income (loss) per common share by dividing net income (loss) by the weighted-average number of common shares outstanding. We compute diluted net income (loss) per common share by dividing net income (loss) by the weighted-average number of common shares and dilutive potential common share equivalents then outstanding during the period. Potential common shares consist of shares issuable upon the vesting of restricted stock units and the exercise of stock options (the proceeds of which are then assumed to have been used to repurchase outstanding shares using the treasury stock method). Because the inclusion of potential common shares would be anti-dilutive for periods presenting a net loss, diluted net loss per common share is the same as basic net loss per common share.
The following table summarizes the computation of basic and diluted net income (loss) per share attributable to common shareholders of the Company (in thousands, except share and per share amounts):
| Three Months Ended<br>March 31, | ||||
|---|---|---|---|---|
| 2025 | 2024 | |||
| Net income (loss) | $ | 56,542 | $ | (18,225) |
| Weighted average common shares outstanding - basic | 56,663,798 | 51,808,849 | ||
| Effect of dilutive securities: | ||||
| Options to purchase common stock | 10,886 | — | ||
| Restricted stock units | 990,000 | — | ||
| Employee stock purchase program | 8,415 | — | ||
| Weighted average common shares outstanding - diluted | 57,673,099 | 51,808,849 | ||
| Net income (loss) per share - basic | $ | 1.00 | $ | (0.35) |
| Net income (loss) per share - diluted | $ | 0.98 | $ | (0.35) |
The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:
| Three Months Ended<br>March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Options to purchase common stock | 10,828,955 | 10,966,720 |
| Unvested restricted stock | — | 19,549 |
| Shares issuable under employee stock purchase plan | — | 86,858 |
| Unvested performance restricted stock units | — | 19,000 |
| Warrants to purchase common stock | 10,757 | 10,757 |
| 10,839,712 | 11,102,884 |
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10. LEASES
The Company has historically entered into lease arrangements for its facilities. As of March 31, 2025, the Company had two operating leases with required future minimum payments. The Company determined the classification of these leases to be operating leases and recorded right-of-use assets and lease liabilities as of the effective dates. The Company’s leases generally do not include termination or purchase options.
Operating leases
In July 2020, the Company entered into a seven-year agreement with an option to extend for five additional years to lease two floors totaling approximately 25,578 square feet of office space for its principal office, which is located in Cambridge, MA. The lease on the first floor commenced on August 1, 2020 and the lease on the second floor commenced March 9, 2021. The Company recognized the respective lease balances on the condensed consolidated balance sheets when the lease of each floor commenced. Under the terms of the lease, the Company was required to issue a $1,168 letter of credit as security for the lease, which was reduced to $779 in August 2023 pursuant to the terms of the lease agreement. Additionally, on December 12, 2022, the Company entered into a sublease for one floor of its Cambridge, Massachusetts office space. The sublease terminates on August 31, 2028, which is also the date on which the Company's lease terminates. Sublease income is recognized on a straight-line basis over the term of the sublease agreement. The Company was not relieved of its primary obligation under the Cambridge office lease as a result of the sublease.
In December 2020, the Company entered into an eleven-year agreement to lease approximately 18,120 square feet of office and laboratory space in New York, NY. The Company has an option to extend the lease for five additional years. The lease commenced August 26, 2021 and the related lease balance was recognized on the condensed consolidated balance sheet. Additionally, on June 19, 2024, the Company entered into a sublease for its office and laboratory space in New York, NY. The sublease terminates on June 30, 2026, with the option to extend to June 30, 2027. Sublease income is recognized on a straight-line basis over the term of the sublease agreement. The Company was not relieved of its primary obligation under the New York lease as a result of the sublease.
The following table contains a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s operating lease for the three months ended March 31, 2025 and 2024:
| Three Months Ended March 31, | ||||||
|---|---|---|---|---|---|---|
| 2025 | 2024 | |||||
| Lease Cost | ||||||
| Operating lease cost | $ | 1,054 | $ | 1,054 | ||
| Short-term lease cost | — | 17 | ||||
| Variable lease cost | 259 | 237 | ||||
| Sublease income | (990) | (456) | ||||
| Total lease cost | $ | 323 | $ | 852 | ||
| Other Operating Lease Information | March 31, 2025 | March 31, 2024 | ||||
| --- | --- | --- | --- | --- | --- | --- |
| Cash paid for amounts included in the measurement of lease liability | $ | 1,109 | $ | 1,080 | ||
| Weighted-average remaining lease term | 5.8 | 6.7 | ||||
| Weighted-average discount rate | 5.3 | % | 5.3 | % |
The variable lease costs for the three months ended March 31, 2025 and 2024 include common area maintenance and other operating charges. As the Company’s leases do not provide an implicit rate, the Company utilized its incremental borrowing rate to discount lease payments, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment.
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11. COMMITMENTS AND CONTINGENCIES
The Company enters into contracts in the normal course of business with contract research organizations (CROs), contract manufacturing organizations (CMOs) and other third parties for preclinical research studies, clinical trials and testing and manufacturing services. These contracts do not contain minimum purchase commitments and are cancelable upon prior written notice. Payments due upon cancellation consist only of payments for services provided or expenses incurred, including noncancelable obligations of service providers, up to the date of cancellation.
License Agreements
The Company is party to license agreements, which include contingent payments. These payments will become payable if and when certain development, regulatory and commercial milestones are achieved. As of March 31, 2025, the satisfaction and timing of the contingent payments is uncertain and not reasonably estimable.
Indemnification agreements
In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not aware of any indemnification arrangements that could have a material effect on its financial position, results of operations or cash flows, and it has not accrued any liabilities related to such obligations in its consolidated financial statements as of March 31, 2025 or December 31, 2024.
Legal proceedings
The Company is not currently party to and is not aware of any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to such legal proceedings.
12. BENEFIT PLANS
The Company has a tax-qualified 401(k) and Profit Sharing defined contribution plan (the 401(k) Plan). Under the 401(k) Plan, the Company provides an employer safe harbor matching contribution equal to 100% of a participant’s eligible contributions of up to 6% of eligible compensation, subject to limits established by the Internal Revenue Code of 1986, as amended, and any regulations promulgated thereunder (the Code). All matching contributions are fully vested when made. During the three months ended March 31, 2025 and 2024, the Company contributed $154 and $348, respectively, to the 401(k) Plan.
13. SEGMENT REPORTING
Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (CODM) in deciding how to allocate resources to an individual segment and in assessing performance. The Company operates as a single reporting segment, focused on the development of MasterKey therapies that target families of oncogenic mutations in patients with cancer.
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The Company’s measure of segment profit or loss is net income (loss). The CODM is the chief executive officer (CEO). The CODM manages and allocates resources to the operations of the Company on a total company basis. Managing and allocating resources on a consolidated basis enables the CEO to assess the overall level of resources available and how to best deploy these resources across functions and development projects that are in line with the Company’s strategic goals. Consistent with this decision-making process, the CEO uses consolidated financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets. Segment net income (loss) is used to monitor budget versus actual results and in assessing performance of the segment.
The following table is a reconciliation of the significant expense categories to segment net income (loss) regularly provided to the CODM when managing the Company’s single reporting segment:
| Three Months Ended<br>March 31, | ||||
|---|---|---|---|---|
| 2025 | 2024 | |||
| (in thousands) | ||||
| License revenue | $ | (70,000) | $ | — |
| Program expenses: | ||||
| BDTX-1535 research and development expenses | $ | 5,204 | $ | 5,742 |
| BDTX-4933 research and development expenses | 1,018 | 1,507 | ||
| Other research programs and development expenses1 | 562 | 602 | ||
| Non-program expenses2 | 3,546 | 4,156 | ||
| Personnel-related expenses | 3,351 | 6,439 | ||
| Other segment items3 | (223) | (221) | ||
| Segment net (income) loss | $ | (56,542) | $ | 18,225 |
(1) Includes cross-program consulting expenses; (2) Includes facilities, information technology, legal, intellectual property, and other general and administrative expense; (3) Includes stock-based compensation expense, depreciation, sublease income, investment accretion, interest income, and other (income) expense.
14. LICENSE REVENUE
In March 2025, the Company entered into a license agreement with Servier. Pursuant to the Servier Agreement, the Company granted to Servier a worldwide license to develop and commercialize BDTX-4933. Under the terms of the Servier Agreement, Servier will lead the development activities and the worldwide commercialization of BDTX-4933 across multiple indications, including NSCLC, with potential applications in other solid tumors. Under the Servier Agreement, the Company received an upfront payment of $70,000 in March 2025 and will be eligible to receive up to $710,000 in development and commercial sales milestone payments, along with tiered royalties based on global net sales. These milestone and royalty payments will become payable to the Company if and when the development and commercial sales milestones are achieved and commercial sales of the licensed product are made.
Unless earlier terminated, the term of the Servier Agreement continues until expiration of the last royalty term for the applicable product in the applicable country. The Servier Agreement is subject to customary termination provisions, including termination by a party for the other party’s uncured, material breach. The Servier Agreement also includes customary representations and warranties, covenants and indemnification obligations.
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The Company assessed the Servier Agreement in accordance with ASC 606 and concluded that the contract counterparty, Servier, is a customer. In accordance with ASC 606, the Company determined that there is one performance obligation in the Servier Agreement, consisting of the license of the functional IP rights to BDTX-4933 granted to Servier. The transaction price was comprised of the fixed consideration of $70,000 and was recognized upon transfer of control of the license at a point in time upon contract execution. The arrangement includes significant variable consideration primarily in the form of development and commercial sales milestone payments and royalty fees.
The development milestone fees are fully constrained at the inception of the contract. The estimate of variable consideration and the judgements related to the constraints for the development milestones are reassessed each reporting period under the most likely amount method. As of and for the three months ended March 31, 2025, the Company determined the events underlying the milestones were not probable, therefore the variable consideration was fully constrained and no adjustments to the estimates have been made.
The commercial sales milestones and royalty fees are considered variable consideration and will be recognized as revenue as such sales occur. The commercial sales milestones and royalty fees qualify for the sales and usage-based royalty exception because the license of the functional IP rights to BDTX-4933 is the predominant element of the Servier Agreement and therefore does not require an estimate of the future transaction price.
During the three months ended March 31, 2025, the Company recorded $70,000 in license revenue pursuant to the Servier Agreement and none in the three months ended March 31, 2024. Our annual 2025 estimated tax expense associated with this revenue, after the use of net operating losses, is $226 and is reflected in our income statement for the three months ended March 31, 2025.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis should be read in conjunction with the unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report and our audited consolidated financial statements and related notes thereto for the year ended December 31, 2024, as well as Management’s Discussion and Analysis of Financial Condition and Results of Operations, included in our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 6, 2025. This discussion and analysis and other parts of this Quarterly Report contain forward-looking statements based upon current beliefs, plans and expectations that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and projections. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth in our Annual Report on Form 10-K and in other SEC filings.
Overview
We are a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer. The foundation of our company is built upon a deep understanding of cancer genetics, onco-protein structure and function, and medicinal chemistry. Our MasterKey therapies are designed to address a broad spectrum of genetically defined tumors, overcome resistance, minimize wild-type mediated toxicities, and be brain-penetrant to treat central nervous system (CNS) disease. Our compounds target families of oncogenic mutations in clinically validated pathways. Our lead clinical-stage program, BDTX-1535, is a brain-penetrant, fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor targeting epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) and glioblastoma (GBM). In March 2025 we announced a global licensing agreement with Servier for our second clinical-stage asset, BDTX-4933, a potential best-in-class targeted therapy for RAF/RAS-mutant solid tumors, and received an upfront payment of $70.0 million.
We believe that our clinical-stage lead product candidate, BDTX-1535, has the potential to treat newly diagnosed patients with EGFRm NSCLC, as well as those with recurrent disease, based upon BDTX-1535’s ability to address greater than 50 classical and non-classical oncogenic driver mutations with greater potency than other EGFR tyrosine kinase inhibitors (TKIs), as well as uniquely target the C797S resistance mutation which can be acquired after treatment with osimertinib. BDTX-1535 was shown to be well tolerated and achieve durable clinical responses in our Phase 1 trial in patients with recurrent EGFRm NSCLC whose tumors expressed a range of mutation subtypes, including the acquired C797S resistance mutation and a broad spectrum of non-classical mutations. We are currently evaluating BDTX-1535 in a Phase 2 clinical trial in the first-line setting in patients with EGFRm NSCLC harboring non-classical EGFR mutations. Initial results from the first-line cohort are anticipated in the fourth quarter of 2025. We plan to solicit U.S. Food and Drug Administration (FDA) feedback in the fourth quarter of 2025 on a potential pivotal registrational path in newly diagnosed patients with non-classical EGFRm NSCLC.
We recently completed enrollment of BDTX-1535 in a Phase 2 clinical trial of 83 patients with EGFRm NSCLC in the second- and third-line settings. In September 2024, we announced initial Phase 2 data from this trial demonstrating encouraging clinical responses and durability of BDTX-1535. The 200 mg daily dose of BDTX-1535 was selected for pivotal development, showing robust EGFRm target coverage and a favorable tolerability profile with no new safety signals observed. Based on an August 2024 data cutoff, a preliminary overall response rate (ORR) of 42% was seen in 19 patients with known osimertinib resistance EGFR mutations (PACC “P-loop αC-helix compressing” and C797S mutations). Acquisition of C797S was frequently observed in patients who progressed following treatment with osimertinib. PACC mutations represent a structure-function group of non-classical oncogenic driver mutations which may accumulate or be acquired following treatment with osimertinib. Encouraging durability was noted with a duration of response (DOR) of approximately eight months or more in the first three patients who achieved a partial response (PR), while 14 of the 19 patients remained on treatment. We expect to present updated results from this trial in the first half of 2026 and are exploring potential combination opportunities for BDTX-1535 in the recurrent setting.
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In June 2024, at the American Society of Clinical Oncology (ASCO) Annual Meeting, we presented preliminary data from the Phase 1 trial of BDTX-1535 in patients with relapsed/recurrent GBM, demonstrating encouraging duration of treatment and clinical activity, and a tolerability profile consistent with the initial safety data from the dose escalation portion of the Phase 1 trial presented in 2023. At the June 2024 ASCO meeting, our collaborators at the Ivy Brain Tumor Center also presented initial intratumoral pharmacokinetic data from a Phase 0/1 trial in patients with recurrent high-grade glioma with EGFR alterations and/or fusions at initial diagnosis. Initial results from this trial, sponsored by the Ivy Brain Tumor Center, demonstrated that BDTX-1535 exceeded the pre-specified threshold for drug concentration in the brain tumor tissue and was generally well tolerated with expected EGFR-mediated side effects. Additional promising results from this trial were presented by the Ivy Brain Tumor Center at the European Association of Neuro-Oncology meeting in October 2024, at the Society of Neuro-Oncology Annual Meeting in November 2024 and at the American Association for Cancer Research annual meeting in April 2025. The data demonstrated that BDTX-1535 penetrated rarely accessible regions of GBM and suppressed EGFR signaling in patient tumors. In March 2025, the Phase 0/1 trial was initiated by the Ivy Brain Tumor Center in newly diagnosed GBM patients with EGFR alterations.
In March 2025, we entered into a global licensing agreement (the Servier Agreement) with Servier Pharmaceuticals LLC (Servier) for our second clinical-stage asset, BDTX-4933, a small molecule designed to address unmet medical needs in RAF/RAS-mutant solid tumors. Under the terms of the Servier Agreement, we granted to Servier a global license to develop and commercialize BDTX-4933. Pursuant to the terms of the Servier Agreement, Servier will lead the development activities and the global commercialization of BDTX-4933 across multiple indications, including NSCLC, with potential applications in other solid tumors. In consideration for the license granted to Servier, we received an upfront payment of $70.0 million in March 2025 and will be eligible to receive up to $710.0 million in development and commercial sales milestone payments, along with tiered royalties based on global net sales. See Note 14, License Revenue, to the condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information.
Since our inception in 2014, we have devoted substantially all of our efforts and financial resources to organizing and staffing our company, business planning, raising capital, discovering product candidates and securing related intellectual property rights while conducting research and development activities for our programs. We do not have any products approved for sale and have not generated any revenue from product sales. We may never be able to develop or commercialize a marketable product. We have not yet successfully completed any pivotal clinical trials, obtained any regulatory marketing approvals, manufactured a commercial-scale drug, or conducted sales and marketing activities.
To date, we have funded our operations with proceeds from the sale of common stock and preferred stock, and through the $70.0 million upfront payment received under the Servier Agreement in March 2025. Since inception, we have incurred significant operating losses. Our net income was $56.5 million and our net loss was $18.2 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $430.6 million. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of our current or future product candidates. We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:
•advance clinical development of BDTX-1535;
•obtain, maintain, expand, enforce and protect our intellectual property portfolio;
•attract and retain key clinical, scientific, management and commercial personnel;
•seek marketing approvals for our product candidates that successfully complete clinical trials, if any; and
•acquire or in-license additional product candidates.
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As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings or other capital sources, which may include collaborations with other companies or other strategic transactions. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates, and reduce headcount and general and administrative costs.
Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
Additionally, we continue to actively monitor macroeconomic conditions and market volatility resulting from global economic developments, political unrest, high inflation, disruptions in capital markets, changes in international trade relationships and military conflicts, and health crises. While we believe such factors have had no significant impact on our business or financial results during the periods presented, future developments and potential impacts on our business are uncertain and cannot be predicted with confidence.
As of March 31, 2025, we had cash, cash equivalents and investments of approximately $152.4 million, which we believe will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and capital resources.” To finance our operations beyond that point, we will need to raise additional capital, which cannot be assured. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives.
Components of our results of operations
Revenue
Since our inception, we have not generated any product revenue and do not expect to generate any revenue from the sale of products for the foreseeable future. To date, we have generated revenue solely from licensing of intellectual property. If our development efforts for our product candidates are successful and result in regulatory approval, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from such collaboration or license agreements. However, there can be no assurance as to when we will generate such revenue, if at all.
Operating expenses
Research and development expenses
Research and development expenses consist primarily of costs incurred for our research activities, including the development of our product candidates. We expense research and development costs as incurred, which include:
•expenses incurred to conduct the necessary preclinical studies and clinical trials required to obtain regulatory approval;
•expenses incurred under agreements with contract research organizations (CROs) that are primarily engaged in the oversight and conduct of our drug discovery efforts, preclinical studies, and clinical trials as well as under agreements with contract manufacturing organizations (CMOs) that are primarily engaged to provide preclinical and clinical drug substance and product for our research and development programs;
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•other costs related to the conduct of preclinical studies, and clinical trials, including acquiring and manufacturing materials, manufacturing validation batches, fees to investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development support services;
•payments made in cash or equity securities under third-party licensing, acquisition and option agreements;
•employee-related expenses, including salaries and benefits, travel and stock-based compensation expense for employees engaged in research and development functions;
•costs related to compliance with regulatory requirements; and
•allocated facilities-related costs, depreciation and other expenses, which include rent and utilities.
We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. Any nonrefundable advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are expensed as the related goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered.
Our direct external research and development expenses consist primarily of external costs, such as fees paid to outside consultants, CROs, CMOs and research laboratories in connection with our preclinical development, process development, manufacturing and clinical development activities. Our direct research and development expenses also include fees incurred under license, acquisition and option agreements. We do not allocate employee costs, costs associated with our development efforts, and facilities, including depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified. We use internal resources primarily to conduct our research as well as for managing our preclinical development, process development, manufacturing and clinical development activities. These employees work across multiple programs and, therefore, we do not track their costs by program.
Development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect that our research and development expenses will increase substantially over the next several years as we continue our clinical development of BDTX-1535. In addition, we may incur additional expenses related to milestone and royalty payments payable to third parties with whom we may enter into license, acquisition and option agreements to acquire the rights to future product candidates.
At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the clinical development of any of our product candidates or when, if ever, material net cash inflows may commence from any of our product candidates. The successful development and commercialization of our product candidates is highly uncertain. This uncertainty is due to the numerous risks and uncertainties associated with product development and commercialization, including the uncertainty of the following:
•the scope, progress, outcome and costs of our clinical trials and other development activities;
•successful patient enrollment in and the initiation and completion of clinical trials;
•the timing, receipt and terms of any marketing approvals from applicable regulatory authorities including the FDA and non-U.S. regulators;
•the extent of any required post-marketing approval commitments to applicable regulatory authorities;
•establishing clinical and commercial manufacturing capabilities or making arrangements with third-party manufacturers in order to ensure that we or our third-party manufacturers are able to make product successfully;
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•development and timely delivery of clinical-grade and commercial-grade drug formulations that can be used in our clinical trials and for commercial launch;
•obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;
•significant and changing government regulation;
•launching commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others; and
•maintaining a continued acceptable tolerability profile of our product candidates following approval, if any, of our product candidates.
Any changes in the outcome of any of these variables with respect to the development of our product candidates could mean a significant change in the costs and timing associated with the development of these product candidates. For example, if the FDA or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate.
General and administrative expenses
General and administrative expenses consist primarily of salaries and benefits, travel and stock-based compensation expense for personnel in executive, business development, finance, human resources, legal, information technology, pre-commercial and support personnel functions. General and administrative expenses also include direct and allocated facility-related costs as well as insurance costs and professional fees for legal, patent, consulting, investor and public relations, accounting and audit services.
We anticipate that our general and administrative expenses will increase in the future as we support continued development of our product candidates and prepare for potential commercialization activities. Additionally, if and when we believe a regulatory approval of a product candidate appears likely, we anticipate an increase in payroll and other employee-related expenses as a result of our preparation for commercial operations, especially as it relates to the sales and marketing of that product candidate.
Other income (expense)
Other income (expense) consists primarily of interest income earned on our cash equivalents and investment balances, sublease income, and realized and unrealized foreign currency transaction gains and losses.
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Results of operations
Comparison of the three months ended March 31, 2025 and 2024
The following table summarizes our results of operations for the three months ended March 31, 2025 and 2024:
| Three Months Ended<br>March 31, | ||||||
|---|---|---|---|---|---|---|
| 2025 | 2024 | Change | ||||
| (in thousands) | ||||||
| License revenue | $ | 70,000 | $ | — | $ | 70,000 |
| Operating expenses: | ||||||
| Research and development | 10,506 | 13,545 | (3,039) | |||
| General and administrative | 4,964 | 6,701 | (1,737) | |||
| Total operating expenses | 15,470 | 20,246 | (4,776) | |||
| Income (loss) from operations | 54,530 | (20,246) | 74,776 | |||
| Other income (expense): | ||||||
| Interest income | 595 | 637 | (42) | |||
| Other (expense) income | 1,417 | 1,384 | 33 | |||
| Total other income (expense), net | 2,012 | 2,021 | (9) | |||
| Net income (loss) | $ | 56,542 | $ | (18,225) | $ | 74,767 |
Revenue
Revenue was $70.0 million for the three months ended March 31, 2025 compared to none for the three months ended March 31, 2024. The increase was a result of the upfront payment we received from Servier under the Servier Agreement.
Research and development
Research and development expenses were $10.5 million for the three months ended March 31, 2025, compared to $13.5 million for the three months ended March 31, 2024. The following table summarizes our research and development expenses for the three months ended March 31, 2025 and 2024:
| Three Months Ended<br>March 31, | ||||||
|---|---|---|---|---|---|---|
| 2025 | 2024 | Change | ||||
| (in thousands) | ||||||
| BDTX-1535 research and development expenses | $ | 5,204 | $ | 5,742 | $ | (538) |
| BDTX-4933 research and development expenses | 1,018 | 1,507 | (489) | |||
| Other research programs and platform development expenses | 562 | 602 | (40) | |||
| Personnel expenses | 2,708 | 4,528 | (1,820) | |||
| Allocated facility expenses | 877 | 860 | 17 | |||
| Other expenses | 137 | 306 | (169) | |||
| $ | 10,506 | $ | 13,545 | $ | (3,039) |
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The decrease of $3.0 million for the three months ended March 31, 2025 was primarily due to a decrease of $0.5 million related to operational efficiencies gained as we progressed our clinical trial for BDTX-1535, combined with decreased spend relating to BDTX-4933 of $0.5 million related to the deprioritization of the program, compared to the three months ended March 31, 2024. In addition, personnel expenses decreased by $1.8 million as we continue to capitalize on workforce efficiencies to focus on advancing and optimizing development plans for BDTX-1535.
General and administrative
General and administrative expenses were $5.0 million for the three months ended March 31, 2025 compared to $6.7 million for the three months ended March 31, 2024. The decrease was primarily a result of operational and workforce efficiencies from our corporate restructuring announced in October 2024.
Other income (expense)
Other income was $2.0 million in each of the three months ended March 31, 2025 and March 31, 2024 as interest income and other income stayed relatively flat.
Liquidity and capital resources
Sources of liquidity
Since our inception, we have not generated any product revenue and do not expect to generate any revenue from the sale of products in the foreseeable future. To date, we have generated revenue solely from licensing of intellectual property. We have incurred significant operating losses and negative cash flows from our operations. We have not yet commercialized any of our product candidates, and we do not expect to generate revenue from sales of any product candidates for several years, if at all. We have funded our operations to date primarily with proceeds from the sale of our common and preferred stock, as well as proceeds from licensing of intellectual property.
On February 3, 2020, we completed an initial public offering (IPO) of 12,174,263 shares of our common stock, including the exercise in full by the underwriters of their option to purchase up to 1,587,947 additional shares of our common stock, for aggregate gross proceeds of $231.3 million. We received $212.1 million in net proceeds after deducting underwriting discounts and commissions and other offering expenses payable by us. Through March 31, 2025, we had received net cash proceeds of $200.6 million from previous sales of our preferred stock.
On November 14, 2022, we filed a shelf registration statement on Form S-3 (the Shelf Registration Statement) with the SEC, which covers the offering, issuance and sale of our common stock, preferred stock, debt securities, warrants and/or units of any combination thereof up to a maximum price of $500.0 million. We simultaneously entered into an Open Market Sale AgreementSM (the Sales Agreement) with Jefferies LLC (Jefferies), as sales agent, to provide for the issuance and sale by us of up to $150.0 million of our common stock (the Shares) from time to time through Jefferies as our sales agent (the ATM Program). The Shelf Registration Statement became effective on November 22, 2022. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, Jefferies may sell the Shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act. We may sell the Shares in amounts and at times to be determined by us from time to time subject to the terms and conditions of the Sales Agreement, but we have no obligation to sell any Shares under the Sales Agreement. We or Jefferies may suspend or terminate the offering of Shares upon notice to the other party and subject to other conditions. As of March 31, 2025, we sold 4,490,853 shares of our common stock pursuant to the ATM Program, resulting in gross proceeds to us of approximately $25.0 million ($24.5 million net of offering costs).
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On July 5, 2023, we completed an underwritten public offering (the Follow-on Offering) of 15,000,000 shares of our common stock at a price to the public of $5.00 per share. The aggregate net proceeds from the Follow-on Offering totaled approximately $71.6 million after deducting underwriting discounts and commissions, as well as other offering expenses. The underwriters did not exercise any portion of their 30-day overallotment option to purchase up to an additional 2,250,000 shares of our common stock at the public offering price, which expired on July 29, 2023, and therefore no additional proceeds from the Follow-on Offering were received.
On March 18, 2025, we entered into the Servier Agreement with Servier for BDTX-4933, a small molecule designed to address unmet medical needs in RAF/RAS-mutant solid tumors, pursuant to which we granted to Servier a global license to develop and commercialize BDTX-4933. Under the terms of the Servier Agreement, Servier will lead the development activities and the global commercialization of BDTX-4933 across multiple indications, including NSCLC, with potential applications in other solid tumors. In consideration for the license granted to Servier, we received an upfront payment of $70.0 million in March 2025 and will be eligible to receive up to $710.0 million in development and commercial sales milestone payments, along with tiered royalties based on global net sales. See Note 14, License Revenue, to the condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information.
As of March 31, 2025, we had cash, cash equivalents and investments of $152.4 million.
Cash flows
The following table summarizes our sources and uses of cash for each of the periods presented (in thousands):
| Three Months Ended<br>March 31, | ||||
|---|---|---|---|---|
| 2025 | 2024 | |||
| Cash provided by (used in) operating activities | $ | 53,410 | $ | (21,199) |
| Cash provided by (used in) investing activities | 8,547 | (13,734) | ||
| Cash provided by financing activities | 32 | 4,130 | ||
| Net increase (decrease) in cash and cash equivalents | $ | 61,989 | $ | (30,803) |
Operating activities
During the three months ended March 31, 2025, we had cash provided by operating activities of $53.4 million, primarily resulting from our net income of $56.5 million, partially offset by the non-cash charge related to stock compensation expense of $1.7 million.
During the three months ended March 31, 2024, we used cash in operating activities of $21.2 million, primarily resulting from our net loss of $18.2 million, partially offset by the non-cash charge related to stock compensation expense of $1.7 million.
Changes in accounts payable and accrued expenses in all periods were generally due to the advancement of our product candidates and the timing of vendor invoicing and payments.
Investing activities
During the three months ended March 31, 2025, we had cash provided by investing activities of $8.5 million primarily from the sales and maturities of investments, netted against our purchase of investments.
During the three months ended March 31, 2024, we had cash used in investing activities of $13.7 million primarily from the sales and maturities of investments, netted against our purchase of investments.
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Financing activities
During the three months ended March 31, 2025, we had cash provided by financing activities of less than $0.1 million, consisting of proceeds from the participation in the employee stock purchase plan.
During the three months ended March 31, 2024, we had cash provided by financing activities of $4.1 million consisting of proceeds from exercise of stock options and participation in the employee stock purchase plan, as well as the sale of shares of our common stock in March 2024 pursuant to the ATM Program.
Funding requirements
We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance clinical trials of BDTX-1535. In addition, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses. The timing and amount of our operating expenditures will depend largely on our ability to:
•advance BDTX-1535 through clinical trials;
•manufacture, or have manufactured on our behalf, our drug material and develop processes for late stage and commercial manufacturing;
•seek regulatory approvals for any product candidates that successfully complete clinical trials;
•establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any product candidates for which we may obtain marketing approval and intend to commercialize on our own; and
•obtain, maintain, expand, enforce and protect our intellectual property portfolio.
As of March 31, 2025, we had cash, cash equivalents and investments of $152.4 million. We believe that our existing cash, cash equivalents and investments will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2027. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We anticipate that we will require additional capital as we seek regulatory approval of our product candidates and if we choose to pursue in-licenses or acquisitions of other product candidates. If we receive regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize.
Because of the numerous risks and uncertainties associated with research, development and commercialization of product candidates, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to further reduce or terminate our operations. Our future funding requirements will depend on and could increase significantly as a result of many factors, including:
•the scope, progress, results and costs of developing our product candidates, and conducting clinical trials;
•the costs, timing and outcome of regulatory review of our product candidates;
•the costs, timing and ability to manufacture our product candidates to supply our clinical development efforts and our clinical trials;
•the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;
•subject to receipt of regulatory approval, the costs of commercialization activities for our product candidates, to the extent such costs are not the responsibility of any future collaborators, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities;
•the ability to receive additional non-dilutive funding;
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•the revenue, if any, received from commercial sale of our product candidates, should any of our product candidates receive marketing approval;
•the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining, expanding and enforcing our intellectual property rights and defending intellectual property-related claims;
•our ability to establish and maintain additional collaborations and license agreements on favorable terms, if at all, and the success of those collaborations and license agreements;
•the extent to which we acquire or in-license other product candidates and technologies; and
•the ongoing costs of operating as a public company and recent increases in inflationary rates.
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time, if ever, as we can generate substantial product revenue from product sales, we expect to finance our operations through a combination of public or private equity offerings, debt financings, collaborations, strategic partnerships and alliances or marketing, distribution or licensing arrangements with third parties or through other sources of financing. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans. However, the trading prices for our common stock and for other biopharmaceutical companies have been highly volatile. As a result, we may face difficulties raising capital through sales of our common stock, and such sales may be on unfavorable terms. Similarly, adverse macroeconomic conditions and market volatility resulting from global economic developments, political unrest, high inflation, global health crises, or other factors could materially and adversely affect our ability to consummate an equity or debt financing on favorable terms or at all. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all.
To the extent that we raise additional capital through the sale of private or public equity or convertible debt securities, the ownership interest of our stockholders may be materially diluted, and the terms of such securities could include liquidation or other preferences and anti-dilution protections that could adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business. In addition, debt financing may involve significant cash payment obligations and specific financial ratios that may restrict our ability to operate our business would result in fixed payment obligations.
If we raise additional funds through collaborations, strategic partnerships and alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves, obtain capital through arrangements with collaborators on terms unfavorable to us or pursue merger or acquisition strategies, all of which could adversely affect the holdings or the rights of our stockholders.
Contractual obligations and commitments
The following summarizes our contractual obligations as of March 31, 2025:
| Payments Due by Period | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Less than 1 Year | 1 to 3 Years | 3 to 5 Years | More than 5 Years | Total | ||||||
| (in thousands) | ||||||||||
| Property leases - commenced | $ | 4,508 | $ | 9,386 | $ | 5,464 | $ | 5,582 | $ | 24,940 |
| Total | $ | 4,508 | $ | 9,386 | $ | 5,464 | $ | 5,582 | $ | 24,940 |
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Property leases – commenced
The amounts reported for property leases represent future minimum lease payments under non-cancelable operating leases in effect as of March 31, 2025. The minimum lease payments do not include common area maintenance charges or real estate taxes.
Other contractual obligations
The contractual obligations table does not include any potential future milestone payments or royalty payments we may be required to make or receive under our existing license agreements due to the uncertainty of the occurrence of the events requiring payment under those agreements.
Critical accounting policies and significant judgments and use of estimates
Our condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States (GAAP). The preparation of our condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses. We base our estimates on historical experience, known trends and events and various other factors that we believe are 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. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations— Critical Accounting Policies and Use of Estimates” in our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 6, 2025, except as described below:
Revenue Recognition
The Company recognizes revenue in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606). This standard applies to all contracts with customers, except for contracts that are within the scope of other standards. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. See Note 2, Summary of Significant Accounting Policies, to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report for additional information.
Recently issued accounting pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report.
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Emerging growth company and smaller reporting company status
The Jumpstart Our Business Startups Act of 2012 (the JOBS Act) permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected to not “opt out” of this provision and, as a result, we will adopt new or revised accounting standards at the time private companies adopt the new or revised accounting standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company.
We are also a “smaller reporting company” meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Effective as of December 31, 2025, the fifth anniversary of the closing of our IPO, we will no longer qualify as an “emerging growth company.” As a result, commencing with our Annual Report on Form 10-K for the fiscal year ending December 31, 2025, we will no longer be eligible to take advantage of certain exemptions from various reporting requirements that are applicable to emerging growth companies.
Item 3. Quantitative and Qualitative Disclosure About Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
Our management, with the participation of our Principal Executive Officer and Principal Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act) as of the end of the period covered by this Quarterly Report. Based on that evaluation, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were effective as of March 31, 2025.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) that occurred during the period covered by this Quarterly Report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II - OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not currently aware of any such proceedings or claims that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk Factors
Our business faces significant risks and uncertainties. Certain important factors may have a material adverse effect on our business prospects, financial condition and results of operations, and you should carefully consider them. Accordingly, in evaluating our business, we encourage you to carefully consider the discussion of risk factors in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, which could materially affect our business, financial condition or future results, in addition to other information contained in or incorporated by reference into this Quarterly Report on Form 10-Q and our other public filings with the Securities and Exchange Commission, or the SEC. The material and other risks and uncertainties described below are not intended to be exhaustive and are not the only ones we face. The material and other risks and uncertainties described below are not intended to be exhaustive and are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business, prospects, financial condition and results of operations. Certain statements in this Quarterly Report are forward-looking statements. Please also see the section entitled “Special Note Regarding Forward-Looking Statements.” There have been no material changes from the risk factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024, except as set forth below.
Inadequate funding for the FDA, other government agencies or comparable foreign regulatory authorities could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
Currently, federal agencies in the U.S. are operating under a continuing resolution that is set to expire on September 30, 2025 and the current U.S. administration is focused on reducing costs of the federal government generally, including significantly reducing the number of government employees. Without appropriation of additional funding to federal agencies, our business operations related to our product development activities for the U.S. market could be impacted. The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of other government agencies or comparable foreign regulatory authorities on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable. The Trump Administration has issued executive orders seeking to greatly reduce the size of the federal workforce, including through layoffs and severance packages offered to employees of federal agencies within the executive branch and independent agencies, including the FDA. Any such reduction in personnel may result in longer review times by the FDA and other agencies.
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Disruptions and personnel turnover, as a result of leadership changes, staff reductions or otherwise, at the FDA, other government agencies or comparable foreign regulatory authorities may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. Changes and cuts in FDA staffing also could result in delays in the FDA’s responsiveness or in its ability to review IND submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all. There is also substantial uncertainty as to how regulatory reform measures being implemented by the current U.S. administration, and other political developments, such as government shutdowns or work stoppages, would impact other U.S. regulatory agencies, such as the FDA, SEC and U.S. Patent and Trademark Office (USPTO), on which our operations rely. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical employees and stop critical activities. If a prolonged government shutdown occurs, including as a result of reaching the debt ceiling or staffing changes, it could significantly impact the ability of the FDA and USPTO to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, government shutdowns could impact our ability to access the public markets and obtain additional capital in the future in order to properly capitalize and continue our operations.
Business, economic or geopolitical disruptions or global health concerns could seriously harm our development efforts and increase our costs and expenses.
Broad-based business, macroeconomic conditions or market volatility resulting from national or global economic developments, political unrest, high inflation, rising interest rates, international tariffs, changes in international trade relationships and military conflicts could adversely affect our ongoing or planned research and development activities. Sanctions imposed by the U.S. and other countries in response to such conflicts may also continue to adversely impact the financial markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability. Tariffs levied by the U.S. and other countries also may adversely affect financial markets and the global economy. For example, the U.S. has recently imposed blanket 10% tariffs on virtually all imports to the U.S. and significantly higher tariffs applicable to imports from many countries, including tariffs aggregating 104% on imports from China, which have resulted in other countries imposing additional tariffs on imports from the U.S., including additional tariffs of 125% on imports from the U.S. announced by China, and is likely to continue to result in more retaliatory tariffs. On April 9, 2025, the U.S. announced a temporary pause on its tariffs applicable to many countries, while increasing the tariffs applicable to imports from China. The current U.S. administration has threatened to continue to broadly impose tariffs, which could lead to corresponding punitive actions by the countries with which the U.S. trades.
Any such disruptions or concerns may impact a broad range of stakeholders, including our target patient populations, the hospitals and clinical sites in which we conduct any of our clinical trials, third parties with whom we engage, including our CROs, suppliers and regulators. Such impacts could materially negatively affect our ability to conduct our business in the manner or on the timelines presently planned by causing delays in the enrollment of our clinical trials, the manufacture and supply of our product candidates, the conduct of experiments and studies and other interruptions and potential limitations on the quality, completeness and interpretability of data we are able to collect.
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Additionally, changes to policy implemented by the U.S. Congress, the Trump administration or any new administration have impacted and may in the future impact, among other things, the U.S. and global economy, international trade relations, unemployment, immigration, healthcare, taxation, the U.S. regulatory environment, inflation and other areas. For example, if the operations of our third-party manufacturers of drug substances and drug products in China were to be negatively affected, it could result in delays or disruptions in the supply of our product candidates and the conduct of our clinical studies. Any negative impact to patient enrollment or treatment or the timing and execution of our clinical trials could cause costly delays to our development programs, which could adversely affect our ability to obtain regulatory approval for and to commercialize our product candidates, increase our operating expenses and have a material adverse effect on our business and financial results. We continue to assess the legislation as it develops to determine whether it could have an effect on our contractual relationships. Also, current inflationary trends in the global economy may impact salaries and wages, costs of goods and transportation expenses, among other things, and recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures may create market and economic instability.
Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.
We have entered into a license agreement, and may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such collaborations, alliances or licensing arrangements.
As part of our strategy, we have entered into a license agreement and may form or seek strategic alliances, create joint ventures or collaborations, or enter into additional licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to our product candidates and any future product candidates that we may develop.
For example, in March 2025, we entered into a global licensing agreement (the Servier Agreement) with Servier Pharmaceuticals LLC (Servier) for our second clinical-stage asset, BDTX-4933, a small molecule designed to address unmet medical needs in RAF/RAS-mutant solid tumors. Under the Servier Agreement, we granted to Servier a worldwide license to develop and commercialize BDTX-4933. Pursuant to the terms of the Servier Agreement, Servier will lead the development activities and the worldwide commercialization of BDTX-4933 across multiple indications, including NSCLC, with potential applications in other solid tumors. Failure by Servier to meet its obligations under the Servier Agreement, to apply sufficient efforts at developing and commercializing licensed products, or to comply with applicable legal or regulatory requirements, may materially adversely affect our business and our results of operations.
Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders or disrupt our management and business. In addition, we face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view our product candidates as having the requisite potential to demonstrate safety, potency, purity and efficacy and obtain marketing approval.
Further, collaborations involving our product candidates are subject to numerous risks, which may include the following:
•collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration;
•collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization of our product candidates based on clinical trial results, changes in their strategic focus due to the acquisition of competitive products, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities;
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•collaborators may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
•collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates;
•a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to their marketing and distribution;
•collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;
•disputes may arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of our product candidates, or that result in costly litigation or arbitration that diverts management attention and resources;
•collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; and
•collaborators may own or co-own intellectual property covering our products that results from our collaborating with them, and in such cases, we would not have the exclusive right to commercialize such intellectual property.
As a result, if we enter into additional collaboration agreements and strategic partnerships or license our product candidates, we may not be able to realize the benefit of such transactions, which could delay our timelines or otherwise adversely affect our business. We also cannot be certain that, following a strategic transaction or license, we will achieve the revenue or specific net income that justifies such transaction. Any delays in entering into new collaborations or strategic partnership agreements related to our product candidates could delay the development and commercialization of our product candidates in certain geographies for certain indications, which would harm our business prospects, financial condition and results of operations.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Recent Sales of Unregistered Equity Securities
None.
Issuer Purchases of Equity Securities
None.
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Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
10b5-1 Plans
From time to time, our officers (as defined in Rule 16a–1(f)) and directors may enter into Rule 10b5-1 or non-Rule 10b5-1 trading arrangements (as each such term is defined in Item 408 of Regulation S-K). During the three months ended March 31, 2025, none of our directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K) during the quarterly period covered by this Quarterly Report on Form 10-Q.
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Item 6. Exhibits
The exhibits listed on the Exhibit Index immediately preceding such exhibits, which is incorporated herein by reference, are filed or furnished as part of this Quarterly Report.
| Exhibit<br><br>No. | Exhibit Index |
|---|---|
| 10.1*† | License Agreement, dated as of March 18, 2025, by and between Servier Pharmaceuticals LLC and the Registrant. |
| 31.1* | Certification of Principal Executive Officer Pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
| 31.2* | Certification of Principal Financial Officer Pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
| 32.1*+ | Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
| 101.INS | Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document. |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document. |
| 101.LAB | Inline XBRL Taxonomy Extension Labels Linkbase Document. |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document. |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document. |
| 104 | Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.) |
| * | Filed herewith. |
| --- | --- |
| + | This certification will not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent specifically incorporated by reference into such filing. |
| † | Portions of this exhibit (indicated by asterisks) were omitted in accordance with the rules of the Securities and Exchange Commission. |
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Black Diamond Therapeutics, Inc. | ||||||
|---|---|---|---|---|---|---|
| Date: May 12, 2025 | By: | /s/ Mark A. Velleca | ||||
| Mark A. Velleca<br><br>President and Chief Executive Officer<br><br>(Principal Executive Officer) | Black Diamond Therapeutics, Inc. | |||||
| --- | --- | --- | ||||
| Date: May 12, 2025 | By: | /s/ Erika Jones | ||||
| Erika Jones<br><br>Senior Vice President, Finance<br><br>(Principal Financial Officer and Principal Accounting Officer) |
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Document
Exhibit 10.1
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. INFORMATION THAT WAS OMITTED HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”.
LICENSE AGREEMENT
by and between
BLACK DIAMOND THERAPEUTICS, INC.
and
SERVIER PHARMACEUTICALS LLC
March 18, 2025
ACTIVE/137201408.8
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| 1. DEFINITIONS. | 2 |
|---|---|
| 2. GRANTS OF LICENSES. | 14 |
| 3. DEVELOPMENT, REGULATORY, MANUFACTURE AND COMMERCIALIZATION. | 15 |
| 4. TRANSITION ACTIVITIES. | 16 |
| 5. GOVERNANCE. | 18 |
| 6. DATA PROTECTION. | 20 |
| 7. CONSIDERATION. | 21 |
| 8. CONFIDENTIALITY. | 28 |
| 9. REPRESENTATIONS AND WARRANTIES. | 30 |
| 10. INTELLECTUAL PROPERTY. | 33 |
| 11. TERM AND TERMINATION. | 36 |
| 12. LIABILITY, INDEMNIFICATION AND INSURANCE. | 40 |
| 13. MISCELLANEOUS. | 43 |
ACTIVE/137201408.8
LICENSE AGREEMENT
This LICENSE AGREEMENT (the “Agreement”) is entered into on March 18, 2025 (the “Effective Date”), by and among Black Diamond Therapeutics, Inc. a company organized under the laws of Delaware, having its principal place of business at One Main Street, 14th Floor, Cambridge, Massachusetts 02142, United States (“Black Diamond”), and Servier Pharmaceuticals, LLC a company incorporated under the laws of Delaware and having its principal place of business at 200 Pier Four Boulevard Boston, Massachusetts 02210 United States (“Servier”). Black Diamond and Servier may each be referred to herein individually as a “Party” and collectively as the “Parties”.
RECITALS
WHEREAS, Black Diamond has developed and owns or otherwise controls all rights to the Licensed Compound and Licensed Product (as defined below);
WHEREAS, Servier is a pharmaceutical group engaged in the research, development and commercialization of pharmaceutical products; and
WHEREAS, subject to the terms of this Agreement, Black Diamond wishes to grant to Servier, and Servier wishes to receive from Black Diamond, a license under the Licensed Technology (as defined below) to further develop, manufacture, commercialize and otherwise exploit the Licensed Compound and Licensed Product in the Field and in the Territory (as defined below).
AGREEMENT
NOW THEREFORE, in consideration of the mutual promises and covenants set forth below and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
1.DEFINITIONS.
1.1.“Accounting Standards” means, with respect to Servier, International Financing Reporting Standards (IFRS) or any successor thereof.
1.2.“Acquired Person” has the meaning set forth in Section 1.23 (Change of Control).
1.3.“Additional Third Party License” has the meaning set forth in Section 7.3.3(a) (Third Party Patents).
1.4.“Adverse Event” means any adverse medical occurrence in a patient or clinical investigation subject that is administered a pharmaceutical product, and which event does not necessarily have to have a causal relationship with the treatment.
1.5.“Affiliate” means any Person directly or indirectly controlled by, controlling, or under common control with, a Party, but only for so long as such control will continue. For purposes of this definition, “control” (including, with correlative
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meanings, “controlled by”, “controlling” and “under common control with”) means (a) possession, direct or indirect, of the power to direct or cause direction of the management or policies of an entity (whether through ownership of securities or other ownership interests, by contract or otherwise), or (b) beneficial ownership of more than fifty percent (50%) of the voting securities or other ownership or general partnership interest (whether directly or pursuant to any option, warrant or other similar arrangement) or other comparable equity interests of an entity; provided, however, that where an entity owns a majority of the voting power necessary to elect a majority of the board of directors or other governing board of another entity, but is restricted from electing such majority by contract or otherwise, such entity will not be considered to be in control of such other entity until such time as such restrictions are no longer in effect. Notwithstanding anything to the contrary herein, [***], and their respective subsidiaries shall not be Affiliates of Servier for purposes of this Agreement, unless Servier provides written notice to Black Diamond of its desire to include any such corporation and its respective subsidiaries as Affiliates of Servier into the scope of this Agreement.
1.6.“Agreement” has the meaning set forth in the preamble.
1.7.“Alliance Manager” has the meaning set forth in Section 5.5 (Alliance Managers).
1.8.“Ancillary Agreements” means the Quality Agreement and, if applicable, the Data Protection Agreement.
1.9.“Annual Net Sales” has the meaning set forth in Section 7.3.1 (Royalty Payments).
1.10.“Applicable Laws” means all applicable laws, statutes, rules, regulations, treaties (including tax treaties), orders, judgments or ordinances having the effect of law of any national, multinational, federal, state, provincial, county, city or other political subdivision, including, to the extent applicable, GCP, GLP and cGMP, as well as all applicable data protection and privacy laws, rules and regulations, in each case that may be in effect from time to time during the Term. For the avoidance of doubt, any specific references to any Applicable Law or any portion thereof, will be deemed to include all amendments thereto or any replacement or successor thereto.
1.11.“Arbitration” has the meaning set forth in Section 13.1.2(c) (Dispute Resolution).
1.12.“Arbitration Request” has the meaning set forth in Section 13.1.2(c) (Dispute Resolution).
1.13.“Assigned Contracts” means the Third Party contracts to be assigned from Black Diamond to Servier as set forth in the Transition Plan.
1.14.“Backup Compounds” means [***]; provided that, [***], then such compound shall be deemed a “Backup Compound” for all intents and purposes hereunder.
1.15.“BDTX-1535” means Black Diamond’s proprietary oral EGFR inhibitor that, as of the Effective Date, is in clinical development for glioblastoma and non-small cell lung cancer.
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1.16.“Black Diamond” has the meaning set forth in the preamble.
1.17.“Black Diamond Indemnified Party” has the meaning set forth in Section 12.2 (Indemnification by Servier).
1.18.“Business Contact” has the meaning set forth in Section 6.1 (Data Protection).
1.19.“Business Contact Data” has the meaning set forth in Section 6.1 (Data Protection).
1.20.“Business Day” means a day other than a Saturday or Sunday on which banking institutions in Paris, France and Cambridge, Massachusetts, United States are not closed.
1.21.“Calendar Quarter” means each of the consecutive three (3) month periods ending on March 31, June 30, September 30, and December 31; provided that the first Calendar Quarter during the Term shall begin on the Effective Date and the last Calendar Quarter during the Term shall end on the date of this Agreement’s termination or expiration.
1.22.“cGMP” means all applicable current Good Manufacturing Practices, including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820; (b) European Directive 2003/94/EC and Eudralex 4; (c) the principles detailed in the ICH Q7 of ICH Guidelines; and (d) the equivalent Applicable Laws in the Territory, each as may be amended and applicable from time to time.
1.23.“Change of Control” means, with respect to a Party (an “Acquired Person”), the occurrence of any of the following events from and after the Effective Date: (a) any Person or group of Persons becomes the beneficial owner (directly or indirectly) of more than fifty percent (50%) of the voting shares of such Acquired Person; (b) such Acquired Person consolidates with or merges into or with another Person pursuant to a transaction in which more than fifty percent (50%) of the voting shares of the acquiring or resulting entity outstanding immediately after such consolidation or merger is not held by the holders of the outstanding voting shares of such Acquired Person immediately preceding such consolidation or merger; or (c) such Acquired Person sells or transfers to a Person other than an Affiliate of such Acquired Person all or substantially all of such Acquired Person’s assets. Notwithstanding the foregoing, the following will not constitute a Change of Control: (i) a sale of capital stock to underwriters in an underwritten public offering of a Party’s capital stock solely for the purpose of financing, (ii) the acquisition of securities of the Acquired Person by any Person or group of Persons that acquires the Acquired Person’s securities in a transaction or series of related transactions the primary purpose of which is to obtain financing for the Acquired Person through the issuance of equity securities, (iii) a transaction solely to change the domicile of a Party; or (iv) a transaction or series of related transactions involving solely the Acquired Person and one or more Affiliates of the Acquired Person.
1.24.“Clinical Data” means all data that are made, collected, or otherwise generated under or in connection with Clinical Trials, including raw data, reports, and results with respect thereto.
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1.25.“Clinical Trial” means a human clinical study conducted on sufficient numbers of human subjects that is designed to (a) establish that a pharmaceutical product is reasonably safe for continued testing, (b) investigate the safety and efficacy of the pharmaceutical product for its intended use, and to define warnings, precautions and adverse reactions that may be associated with the pharmaceutical product in the dosage range to be prescribed or (c) support Regulatory Approval of such pharmaceutical product or label expansion of such pharmaceutical product.
1.26.“Co-Chair” has the meaning set forth in Section 5.4 (Co-Chairs).
1.27.“Combination Licensed Product” means [***].
1.28.“Commercialization” means any and all activities of using, importing, exporting, marketing, promoting, distributing, offering for sale or selling a product including pre-commercial launch market development activities conducted in anticipation of Regulatory Approval of a product, seeking pricing and reimbursement approvals for a product, if applicable, preparing advertising and promotional materials, sales force training, all interactions and correspondence with a Regulatory Authority, medical affairs, and all activities required to fulfill ongoing regulatory obligations, including Adverse Event reporting. Commercialization shall not include Development or Manufacturing. When used as a verb, “Commercialize” means to engage in Commercialization.
1.29.“Commercially Reasonable Efforts” means, [***].
1.30.“Compassionate Use” means the use of a Licensed Product as an investigational drug in accordance with Applicable Law outside of a Clinical Trial to treat a patient with a serious or life-threatening disease or condition who has no comparable or satisfactory alternative treatment options, including any managed access programs.
1.31.“Competing Product” has the meaning set forth in Section 2.4.1 (Exclusivity).
1.32.“Confidential Information” means, with respect to each Party, all Know-How or other information, including proprietary information and materials (whether or not patentable) regarding or embodying such Party’s or its Representatives’ technology, products, business information or objectives, that is communicated by or on behalf of the Disclosing Party to the Receiving Party or its permitted recipients before, on or after the Effective Date. Confidential Information does not include any Know-How or other information that (a) was already known by the Receiving Party (other than under an obligation of confidentiality to the Disclosing Party) at the time of disclosure by or on behalf of the Disclosing Party, (b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party, (c) became generally available to the public or otherwise part of the public domain after its disclosure to the Receiving Party, other than through any act or omission of the Receiving Party in breach of its obligations under this Agreement, (d) was disclosed to the Receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the Disclosing Party not to disclose such information to the Receiving Party or (e) was independently discovered or developed by or on behalf of the Receiving Party without the use of any Confidential Information belonging to the Disclosing Party. [***].
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1.33.“Control” or “Controlled” means, with respect to any Intellectual Property Right, information, documents or materials of a Party, the ability of such Party or its Affiliates to grant a license, sublicense or other right to or under such Intellectual Property Right, information, documents or materials as provided for herein without (a) violating the terms of any agreement or other arrangement with any Third Party, (b) incurring any payment obligation to a Third Party, or (c) violating any Applicable Law. Notwithstanding the foregoing, following the consummation of a Change of Control of a Party, such Party will not be deemed to “Control” any Intellectual Property Right that is owned or in-licensed by an Affiliate that has become an Affiliate of such Party solely as a result of such Change of Control, unless: (i) immediately prior to the consummation of such Change of Control, such Party or any of its Affiliates also Controlled such Intellectual Property Right or (ii) after the consummation of such Change of Control, such Party or any of its Affiliates uses any such Intellectual Property Right in the performance of its obligations or exercise of its rights under this Agreement, and in each of these cases (clauses (i) and (ii)) such Intellectual Property Right will be “Controlled” by such Party for purposes of this Agreement.
1.34.“Cover” means, with respect to a product, that, in the absence of ownership of or a license granted under a particular Patent Right, the Manufacture, Development, Commercialization, including the use, offer for sale, sale or importation, of such product would infringe a Valid Claim of such Patent Right or, in the case of a Valid Claim of a Patent Right that has not yet issued, would infringe such claim if it were to issue without material change. “Covering” will have correlative meaning.
1.35.“Data Protection Agreement” has the meaning set forth in Section 6.2 (Data Processing Agreement).
1.36.“Defaulting Party” has the meaning set forth in Section 11.3.1(a) (Termination for Material Breach).
1.37.“Development” means all activities related to research, preclinical testing, test method development and stability testing, toxicology, formulation, Clinical Trials, seeking Regulatory Approval and otherwise handling regulatory affairs, statistical analysis and report writing. Development shall not include Manufacturing, Commercialization or the performance of medical affairs activities. When used as a verb, “Develop” means to engage in Development.
1.38.“Development and Regulatory Milestone Event” has the meaning set forth in Section 7.2.1 (Development and Regulatory Milestone).
1.39.“Development and Regulatory Milestone Payment” has the meaning set forth in Section 7.2.1 (Development and Regulatory Milestone).
1.40.“Development Data” means [***].
1.41.“Directed To” means [***].
1.42.“Direct License” has the meaning set forth in Section 11.5.10 (Effects of Termination, Sublicenses).
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1.43.“Disclosing Party” has the meaning set forth in Section 8.1 (Confidential Information).
1.44.“Effective Date” has the meaning set forth in the preamble.
1.45.“European Union” means the economic, scientific and political organization of member states of the European Union as it may be constituted from time to time, which as of the Effective Date consists of Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and that certain portion of Cyprus included in such organization.
1.46.“Exclusive Licensed Patent Rights” means [***].
1.47.“Executive Officers” means [***].
1.48.“Export Control Laws” means all Applicable Laws and regulations providing a framework for regulating the export, to a third country, of goods, software, technology, services and Intellectual Property Right, which, depending on their technical specificities, are either likely to be used for military or both civilian and military purposes (so-called “dual-use”) or prohibited from export but for specific authorizations by the competent authorities.
1.49.“FDA” means the United States of America Food and Drug Administration or any successor agency thereto.
1.50.“FD&C Act” means the United States of America Federal Food, Drug, and Cosmetic Act, as amended, and the regulations promulgated thereunder.
1.51.“Field” means all human uses.
1.52.“Financial Records” has the meaning set forth in Section 7.4.5 (Record Keeping).
1.53.“Finished Product” shall mean [***].
1.54.“First Commercial Sale” means, with respect to a Licensed Product [***].
1.55.“Force Majeure” has the meaning set forth in Section 13.2 (Force Majeure).
1.56.“FPI” means, with respect to a Clinical Trial of an investigational drug, that the first human subject enrolled in such Clinical Trial has been dosed with such investigational drug.
1.57.“FTE” means [***] carrying out Development, Manufacturing or Commercialization activities under this Agreement. [***].
1.58.“FTE Rate” means [***]. For the avoidance of doubt, such FTE Rate (a) is [***] and (b) is [***].
1.59.“GCP” means good clinical practices, which are the then-current standards for Clinical Trials for pharmaceuticals, as set forth in the FD&C Act or other Applicable Law, and such standards of good clinical practice as are required by
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the Regulatory Authorities of [***] and other organizations and Governmental Authorities in countries for which the applicable Licensed Product is intended to be Developed.
1.60.“Generic Product” means, on a country-by-country basis, any pharmaceutical product that [***].
1.61.“GLP” means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58 or the successor thereto, or comparable regulatory standards in jurisdictions outside of the United States.
1.62.“Governmental Authority” means any court, agency, department, authority or other instrumentality of any national, state, county, city or other political subdivision.
1.63.“ICH Guidelines” mean the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline.
1.64.“IND” means an investigational new drug application filed with a Regulatory Authority for obtaining the authorization to administer the Licensed Product to humans in a Clinical Trial in a country of the Territory.
1.65.“Indication” means a specific disease, condition, or clinical manifestation for which a product is developed, tested, approved, and marketed. For the purposes of this Agreement, [***].
1.66.“Indemnified Party” has the meaning set forth in Section 12.3 (Procedure).
1.67.“Indemnifying Party” has the meaning set forth in Section 12.3 (Procedure).
1.68.“Inflation Reduction Act” means P.L. 117-169 (Aug. 16, 2022), as codified at 42 U.S.C. § 1320f, 42 U.S.C. § 1395w-3a and 42 U.S.C. § 1395w-114a (inter alia), as may be amended from time to time, together with any rules, regulations, and requirements promulgated thereunder.
1.69.“Infringement” has the meaning set forth in Section 10.4.1 (Third Party Infringement).
1.70.“Infringement Action” has the meaning set forth in Section 10.4.2 (Infringement Actions).
1.71.“Insolvency Event” has the meaning set forth in Section 11.3.2 (Termination for Bankruptcy).
1.72.“Intellectual Property Rights” means all trade secrets, copyrights, Patent Rights, trademarks, moral rights, Know-How and any and all other intellectual property or proprietary rights now known or hereafter recognized in any jurisdiction.
1.73.“Interim Manufacturing” has the meaning set forth in Section 4.1.9 (Transition Plan).
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1.74.“Inventory” means the materials and inventory existing on the Effective Date, as listed on Schedule 1.74.
1.75.“Joint Transition Plan Committee” or “JTPC” has the meaning set forth in Section 5.1.1 (Establishment and Duration).
1.76.“Know-How” means all inventions, discoveries, data, information (including scientific, technical or regulatory information), processes, methods, techniques, materials, samples, technology, results, analyses, data and information contained in Regulatory Materials and other know-how, whether or not patentable, including Development Data.
1.77.“Liability” has the meaning set forth in Section 12.1 (Indemnification by Black Diamond).
1.78.“Licensed Combination Product Patent Rights” means [***].
1.79.“Licensed Compound” means [***].
1.80.“Licensed Know-How” means [***].
1.81.“Licensed Patent Rights” means [***].
1.82.“Licensed Product” means [***].
1.83.“Licensed Technology” means the Licensed Know-How and the Licensed Patent Rights.
1.84.“Major European Markets” means [***] and their respective territories and possessions.
1.85.“Manufacture”, “Manufactured” or “Manufacturing” means all activities associated with the production, manufacture, processing, filling, finishing, packaging, labeling, shipping and storage of a product to be Developed or Commercialized in the Territory under this Agreement, whether such activities are conducted by a Party, its Affiliates or a Third Party contractor of such Party. Manufacture shall not include Development, Commercialization or the performance of medical affairs activities. When used as a verb, “Manufacture” means to engage in Manufacturing.
1.86.“Manufacturing Costs” means, with respect to the Licensed Compound and Licensed Product, contract manufacturer costs for production for drug substance, transportation between drug substance contract manufacturer to drug product contract manufacturer, contract manufacturer costs for production for drug product, and Third Party consulting costs to manage the process, in each case as documented in writing (e.g., by corresponding invoices).
1.87.“Manufacturing Know-How” means all Licensed Know-How that is necessary or reasonably useful for the Manufacture of the Licensed Compound or a Licensed Product.
1.88.“Marketing Authorization” means, with respect to a Licensed Product in a country or jurisdiction in the Territory, those approval(s) of a Regulatory
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Authority that are necessary for the commercial marketing and sale of such Licensed Product in such country or jurisdiction.
1.89.“Maximum Fair Price” means the maximum fair price under the Inflation Reduction Act’s drug price negotiation program as defined in 42 U.S.C. §1320f(c)(3) and all its subsequent amendments and replacements and guidance or regulations promulgated thereunder.
1.90.“Net Sales” means the gross amounts billed or invoiced, or to the extent not billed or invoiced, the gross amount received, by Servier and its Affiliates and Sublicensees for Licensed Products in any country during the Royalty Term for such Licensed Products in such country, less:
[***].
With respect to Combination Licensed Products, the following will apply:
[***].
If the Parties are unable to reach agreement on such adjustment in Net Sales within [***] after the Parties initiate discussions, then Section 13.1.2 (Dispute Resolution) shall apply.
[***].
1.91.“Non-Defaulting Party” has the meaning set forth in Section 11.3.1(a) (Termination for Material Breach).
1.92.“NSCLC” means non-small cell lung cancer.
1.93.“Ongoing Phase 1 Clinical Trial(s)” means the Phase 1 Clinical Trial entitled BDTX-4933 101 Study (NCT05786924).
1.94.“Other Active Ingredient” has the meaning set forth in Section 1.27 (Combination Licensed Product).
1.95.“Party” has the meaning set forth in the preamble.
1.96.“Patent Right” means any and all (a) patent applications filed under Applicable Law in any jurisdiction, including all provisional applications, substitutions, continuations, continuations-in-part, divisionals, renewals, and all patents granted thereon, (b) all patents, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates or the equivalent thereof, and (c) any other form of government-issued right substantially similar to any of the foregoing.
1.97.“Payments” has the meaning set forth in Section 7.4.2(a) (General).
1.98.“Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint
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venture, or similar entity or organization, including a government or political subdivision or department or agency of a government.
1.99.“Phase 1 Clinical Trial” means a Clinical Trial that is intended to initially evaluate the safety and/or pharmacological effect of a product or that would otherwise satisfy the requirements of 21 C.F.R. 312.21(a) or an equivalent Clinical Trial in a country other than the United States.
1.100.“Phase 1 Clinical Trial Expansion Cohort” means that an additional group of study participants is enrolled in the Phase 1 Clinical Trial after the initial dose-escalation phase in order to gather more data on safety, tolerability and preliminary efficacy at the selected Phase 2 dose.
1.101.“Phase 2 Clinical Trial” means a Clinical Trial for which the primary endpoints include a determination of dose ranges or an indication of efficacy of a product in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent Clinical Trial in a country other than the United States.
1.102.“Phase 2a Clinical Trial” means the first Phase 2 Clinical Trial of a product, the principal purpose of which is an initial evaluation of efficacy of the product.
1.103.“Phase 2/3 Clinical Trial” means a combined clinical trial that includes both a Phase 2 part for which the primary endpoints include a determination of dose ranges or an indication of efficacy of a product in patients being studied, and a Phase 3 part designed to demonstrate statistically whether a product is safe and effective for use in humans in the indication being investigated in a manner sufficient to obtain Regulatory Approval to commercialize such product in patients having the disease or condition being studied.
1.104.“Phase 3 Clinical Trial” means a Clinical Trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in the indication being investigated in a manner sufficient to obtain Regulatory Approval to commercialize such product in patients having the disease or condition being studied as described in 21 C.F.R. §312.21(c), or an equivalent Clinical Trial in a country other than the United States.
1.105.“Quality Agreement” has the meaning set forth in Section 4.7 (Quality Agreement).
1.106.“RAF” means Rapidly Accelerated Fibrosarcoma.
1.107.“RAS” means Rat Sarcoma.
1.108.“RAS-RAF Inhibitor” means [***].
1.109.“Receiving Party” has the meaning set forth in Section 8.1 (Confidential Information).
1.110.“Recipients” has the meaning set forth in Section 8.1 (Confidential Information).
1.111.“Regulatory Approval” means, with respect to a Licensed Product in a country or jurisdiction in the Territory, those approval(s), licenses, registration or authorization of a Regulatory Authority that are reasonably necessary to
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Develop, Manufacture or Commercialize a Licensed Product in the Field in a particular country. Regulatory Approvals include, without limitation, IND approvals, and amendments and supplements to any of the foregoing and their foreign counterparts.
1.112.“Regulatory Authority” means any national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in each country of the world involved in the granting of Regulatory Approval for a Licensed Product.
1.113.“Regulatory Communication” means any material communications from any Regulatory Authority, including with respect to: Clinical Trial protocols and amendments thereto, meeting requests and materials, requests for information and responses thereto, clinical hold notices, investigator’s brochures, and INDs.
1.114.“Regulatory Exclusivity” means, with respect to any country in the Territory, an additional market protection, other than Patent Rights protection, granted by a Regulatory Authority in such country which confers an exclusive Commercialization period during which Servier or its Affiliates or Sublicensees have the exclusive right to market and sell the Licensed Product in such country through a regulatory exclusivity right (e.g., new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity, or any applicable data exclusivity).
1.115.“Regulatory Materials” means (a) regulatory applications, submissions, notifications, registrations, or other filings made to or with a Regulatory Authority, and (b) Regulatory Communications and all supporting documents with respect thereto, including all adverse event files, and complaint files, in each case ((a) and (b)), that are reasonably necessary in order to Develop, Manufacture, market, sell or otherwise Commercialize the Licensed Product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs.
1.116.“Representatives” means (a) with respect to Servier, Servier, its Affiliates, its Sublicensees and each of their respective officers, directors, employees, consultants, contractors and agents and (b) with respect to Black Diamond, Black Diamond, its Affiliates, and each of their respective officers, directors, employees, consultants, contractors and agents.
1.117.“Royalty Rates” has the meaning set forth in Section 7.3.1 (Royalty Payments).
1.118.“Royalty Term” has the meaning set forth in Section 7.3.2 (Royalty Term).
1.119.“Rules” has the meaning set forth in Section 13.1.2 (Dispute Resolution).
1.120.“Safety Reason” means [***] reasonable belief, that, based upon scientific data, there are safety and public health issues relating to the Licensed Product such that the medical benefit/risk ratio of such Licensed Product is sufficiently unfavorable as to materially compromise the welfare of patients to Develop or Commercialize or to continue to Develop or Commercialize it. For clarity, [***].
1.121.“Sales Milestone Event” has the meaning set forth in Section 7.2.2 (Sales Milestones).
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1.122.“Sales Milestone Payment” has the meaning set forth in Section 7.2.2 (Sales Milestones).
1.123.“Sanctions” means any individual, economic, financial (or similar) restrictive measures imposed by a state, international or supranational organization against a country, region, sector, individual or legal entity, or goods, software, technology, services and Intellectual Property Rights on which import and export restrictions may be applied.
1.124.“Servier” has the meaning set forth in the preamble.
1.125.“Servier Foreground IP” has the meaning set forth in Section 10.2.1 (Inventions).
1.126.“Servier FY” means the Servier fiscal year starting on 1st October and ending on 30th September of each year.
1.127.“Servier Indemnified Party” has the meaning set forth in Section 12.1 (Indemnification by Black Diamond).
1.128.“Single Active Licensed Product” means [***].
1.129.“Sublicense” means a written agreement pursuant to which a license, sublicense, covenant not to sue or other grant of rights under the licenses granted pursuant to Section 2.1 (License to Servier) of this Agreement has been granted, subject to Section 2.2.1 (Servier’s Right to Sublicense).
1.130.“Sublicensee” means an Affiliate or Third Party that is granted a Sublicense.
1.131.“Territory” means worldwide.
1.132.“Term” has the meaning set forth in Section 11.1 (Term).
1.133.“Terminated Country” means (a) any country in the Territory with respect to which this Agreement is terminated pursuant to Article 11 (Term and Termination), and (b) in the event of termination of this Agreement in its entirety, all countries in the Territory, in each case, other than, for the avoidance of doubt, as a result of expiration.
1.134.“Third Party” means any Person other than Black Diamond and its Affiliates and Servier and its Affiliates.
1.135.“Third Party Manufacturers” shall mean [***].
1.136.“Transition Period” means the period of time starting on the Effective Date and ending on the completion of all activities to be conducted and all services to be provided under the Transition Plan, provided that, with respect to the performance of services, a service will be completed once the respective service period, as set out in the Transition Plan, has expired.
1.137.“Transition Plan” has the meaning set forth in Section 4.1 (Transition Plan).
1.138.“United Kingdom” or “U.K.” means England, Scotland, Wales and Northern Ireland.
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1.139.“United States” or “U.S.” means the United States of America and all of its territories and possessions, including the District of Columbia.
1.140.“Valid Claim” means any claim of any (a) issued and unexpired Patent Right that has not been (i) revoked or held unenforceable, unpatentable or invalid by a Governmental Authority of competent jurisdiction in a decision that is not appealable or that has not been appealed within the time allowed for appeal, (ii) abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise; or (b) pending patent application that continues to be prosecuted in good faith and has not been cancelled, withdrawn or abandoned; provided that such pending applicable has not been pending for more than [***].
1.141.“VAT” has the meaning set forth in Section 7.4.2(c) (VAT).
2.GRANTS OF LICENSES.
2.1.License to Servier. Subject to the terms and conditions of this Agreement, Black Diamond hereby grants to Servier and its Affiliates a royalty-bearing, non-transferable (except in accordance with Section 13.9 (Assignment)) license, with the right to grant sublicenses through multiple tiers (solely in accordance with Section 2.2 (Right to Sublicense)), under the Licensed Technology to Develop, Manufacture, Commercialize and otherwise exploit the Licensed Compound and Licensed Products in the Field in the Territory. [***].
2.2.Right to Sublicense.
2.2.1.Servier’s Right to Sublicense.
(a)Servier shall have the right to grant Sublicenses under the rights granted to Servier in Section 2.1 (License to Servier) to its Affiliates and to Third Parties for the [***] following such execution (which copy may be redacted to the extent not reasonably necessary for Black Diamond to confirm compliance with this Agreement). For the avoidance of doubt, [***].
(b)Notwithstanding any Sublicense, Servier will remain liable and responsible for all of Servier’s duties and obligations contained in this Agreement (including all payments due hereunder), and any act or omission of a Sublicensee which would be a breach of this Agreement if performed (or not performed) by Servier shall be deemed a breach by Servier of this Agreement.
2.2.2.Sublicense Requirements. Each Sublicense or subcontract (a) shall be consistent with the terms and conditions of this Agreement, including the confidentiality requirements set forth in Article 8 (Confidentiality) and the intellectual property provisions set forth in this Agreement; and (b) shall require the Sublicensee(s) or subcontractor(s) to comply with all terms of this Agreement applicable to such Sublicensees and subcontractors (except for the payment obligations, for which Servier shall remain financially responsible).
2.2.3.Contractors. Servier, its Affiliates and Sublicensees shall be entitled to grant rights or licenses under the license granted to Servier and its Affiliates pursuant to Section 2.1 (License to Servier) to any Third Party to provide contract services with respect to the [***], and such contractor or distributor shall not be a “Sublicensee” for purposes of this Agreement. Servier will remain responsible for its obligations under the Agreement and shall be responsible for the performance of each such Affiliate and Third Party contractor. Each grant of
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rights under this Section 2.2.3 (Contractors) shall comply with the requirements in Section 2.2.2 (Sublicense Requirements).
2.3.No Other Rights and Retained Rights. No rights, other than those expressly set forth in this Agreement are granted to either Party hereunder, and no additional rights shall be deemed granted to either Party by implication, estoppel or otherwise, with respect to any Intellectual Property Rights. All rights not expressly granted by either Party to the other hereunder are reserved.
2.4.Exclusivity; Use of Licensed Technology.
2.4.1.Exclusivity. Subject to Section 2.4.2 (Change of Control of Black Diamond) and Section 2.4.3 (Acquisition of a Competing Product), [***], Black Diamond shall not, and shall cause its respective Affiliates not to, either themselves or in collaboration with a Third Party, [***].
2.4.2.Change of Control of Black Diamond. Section 2.4.1 (Exclusivity) shall not apply to any Competing Product that [***].
2.4.3.Acquisition of a Competing Product. In the event that Black Diamond acquires a Third Party (whether by way of a sale of assets, merger, consolidation or similar transaction) (an “Acquired Entity”) that owns or otherwise Controls a Competing Product at the closing of such transaction, [***].
3.DEVELOPMENT, REGULATORY, MANUFACTURE AND COMMERCIALIZATION.
3.1. General Responsibilities. Subject to Servier’s diligence obligations as set out in Section 3.3 (Diligence Obligations), Servier shall have the sole right, control and responsibility, at its own cost and expense, and shall, subject to Section 5.3 (Decision-Making), have full decision-making authority for managing and conducting all Development, Manufacturing and Commercialization activities for the Licensed Compound and Licensed Products in the Field in the Territory.
3.2.Regulatory Materials and Regulatory Interactions. Following the effective date of the transfer of the IND for the Ongoing Phase 1 Clinical Trial, Servier or its designee will hold the Regulatory Approvals for the Licensed Product in the Field in the Territory and will be responsible for all Regulatory Materials, including Regulatory Communications and interactions with Regulatory Authorities in the Territory, at its sole cost and expense.
3.3.Diligence Obligations. During the Term, [***]. The Parties acknowledge and agree [***].
3.4.Progress Reporting. Following the Transition Period, [***], Servier will deliver to Black Diamond a written report (which may be in the form of a slide deck or other format) that (a) prior to the first Marketing Authorization of the Licensed Product, outlines [***] and (b) following the grant of the first Marketing Authorization for the Licensed Product[***].
3.5.Regulatory Inspections. Subject to the terms and conditions of Black Diamond’s agreements with Third Party Manufacturers, Black Diamond shall cooperate in good faith and in a timely manner with Servier, if necessary and appropriate, with respect to Regulatory Authority inspections of any site or facility where activities related to the Licensed Compound or Licensed Product are performed pursuant to this Agreement. With respect to any costs incurred [***]. Furthermore, [***].
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4.TRANSITION ACTIVITIES.
4.1.Transition Plan. Schedule 4.1 (Transition Plan) sets forth the initial plan and timelines for the transition of all Development, Manufacturing and regulatory activities from Black Diamond (or Third Parties acting on its behalf) to Servier (“Transition Plan”). Each Party shall perform the tasks and obligations allocated to such Party under the Transition Plan. Without limiting the foregoing, Black Diamond will perform the following activities under the Transition Plan:
4.1.1.effect a technology transfer of the Licensed Know-How (including Manufacturing Know-How), to the extent set forth in the Transition Plan;
4.1.2.assign or transfer to Servier or its designated Affiliate(s) (a) [***]; (b) [***]; and (c) [***];
4.1.3.until such time as the assignment and transfers contemplated by the foregoing Section 4.1.2 (Transition Plan) have occurred (the “Regulatory Transition Date”), under the direction of, and in accordance with the instructions provided by Servier, handle all regulatory matters involving interactions with a Regulatory Authority;
4.1.4.until the Regulatory Transition Date, promptly (and in any event no later than [***] after receipt) provide Servier with copies of any Regulatory Communications received by Black Diamond in relation to the Licensed Compound, and allow Servier to review and comment on any proposed response to such Regulatory Communication in advance of the transmission of such response to the respective Regulatory Authority (and Black Diamond will implement all comments reasonably provided by Servier in good faith);
4.1.5.following the Regulatory Transition Date, promptly provide Servier with copies of any Regulatory Communications received by Black Diamond in relation to the Licensed Compound;
4.1.6.provide Servier with advance notice of all meetings and teleconferences with Regulatory Authorities pertaining to the Licensed Product, and permit Servier to have representatives attend such formal meetings and teleconferences with the Regulatory Authorities pertaining to the Licensed Product;
4.1.7.support and transfer the Ongoing Phase 1 Clinical Trial in accordance with the modalities and timelines set forth in the Transition Plan;
4.1.8.assign, or otherwise transfer rights under, the Assigned Contracts to Servier (including all existing contract documentation in its possession (or transfer access rights, as applicable) regarding the Assigned Contracts), solely in relation to the Licensed Compound and the Licensed Product, and to the extent and in accordance with the timelines set forth in the Transition Plan, and, in case the assignment of an Assigned Contract requires the consent of the counterparty, use commercially reasonable efforts to obtain such consent; provided that, if any [***];
4.1.9.during the Transition Period, until such time as Servier is able to Manufacture or have Manufactured sufficient quantities of Licensed Compound and Licensed Product to fully support its Development activities in the Territory under this Agreement, Manufacture or have Manufactured and supply Licensed Compound and Licensed Product, including the Finished Product, in the quantities required by Servier to support the Development activities of Servier in the Territory under this Agreement (the “Interim
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Manufacturing”), which Interim Manufacturing will, in all cases, be subject to the terms and conditions of the applicable agreements with Third Party Manufacturers; and
4.1.10.deliver to Servier or its designee (as set forth in the Transition Plan) the Inventory in accordance with the delivery terms, dates and locations set out in the Transition Plan, provided that the terms and conditions governing the condition of (or inspection rights with respect to) such Inventory will in all cases be subject to the applicable agreements with Third Party Manufacturers and the rights and remedies thereunder.
4.2.Updates and Amendments to the Transition Plan. The JTPC shall review the Transition Plan on an ongoing basis and may discuss and agree in writing on updates or amendments to the Transition Plan from time to time in accordance with Section 5.1.3 (Responsibilities), and subject to Section 5.3 (Decision-Making); provided that, [***].
4.3.Transfer of Licensed Know-How. To the extent not already transferred under the Transition Plan, upon the reasonable request of Servier, Black Diamond shall provide or cause to be provided to Servier copies of [***]. Furthermore, Black Diamond will [***]. Following such date, Black Diamond will [***].
4.4.Audits. Subject to the terms and conditions of Black Diamond’s agreements with Third Party contractors, if Black Diamond has an audit right under a Third Party agreement that is an Assigned Contract and Servier desires that Black Diamond exercises such audit right prior to a transfer of the relevant Third Party agreement to confirm compliance with Applicable Laws, including cGMP, GCP and GLP, of any site or facility where Development and Manufacturing activities with respect to the Licensed Compound or Licensed Product have been or will be conducted, then Black Diamond will [***]. If, following the review of such results, Servier determines that any such audited site or facility is not compliant with Applicable Law, the Parties will discuss in good faith a remedy plan, and Black Diamond will require that the applicable Third Party implement such plan in a timely manner, or otherwise exercise the available remedies under such contract, in each case to the extent permitted under such Third Party agreement.
4.5.Timely Performance. The Parties acknowledge that time is of the essence and each Party shall (a) complete all activities and provide all services to be performed under this Article 4 (Transition Activities), (b) complete all activities and provide all services to be performed under the Transition Plan in accordance with the timelines set out in the Transition Plan, and (c) take or cause to be taken such reasonable steps as are necessary to minimize any delay with respect thereto. [***].
4.6.Costs for Transition Activities.
4.6.1.Transition Plan. Except as otherwise expressly set forth in the Transition Plan or in this Section 4.6 (Costs for Transition Activities), each Party shall bear its own costs for the activities assigned to such Party under the Transition Plan.
4.6.2.Assigned Contracts. Black Diamond shall remain solely responsible for [***]. With respect to [***], Servier shall be responsible for such costs and expenses, and will reimburse Black Diamond for any such costs within [***] following receipt of an invoice from Black Diamond.
4.6.3.Transfer of Inventory; Interim Manufacturing. Servier will reimburse Black Diamond for the actual and documented [***]. With respect to any Interim Manufacturing provided by Black Diamond under the Transition Plan, Servier will pay to Black
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Diamond the [***]. Servier will pay Black Diamond for any such costs within [***] following receipt of an invoice from Black Diamond.
4.6.4.Technical Support. Following the date that is [***], any support provided by Black Diamond under this Agreement, including under Section 4.3, shall be at Black Diamond’s cost and expense for the [***], and any support in excess of [***] will be charged at the [***]; provided that Black Diamond will not charge Servier for any [***] and any such support will [***]. Servier will reimburse Black Diamond for any such costs within [***] following receipt of an invoice from Black Diamond.
4.7.Quality Agreement. Within [***] after the Effective Date, and in any event [***], the Parties will enter into a quality agreement (“Quality Agreement”) setting forth the Parties’ [***]. The Quality Agreement is hereby incorporated into this Agreement by reference, as applicable.
5.GOVERNANCE.
5.1.Joint Transition Plan Committee.
5.1.1.Establishment and Duration. Within [***] of the Effective Date, the Parties shall establish a joint transition plan committee (“Joint Transition Plan Committee” or “JTPC”) that will oversee the implementation of the Transition Plan. The JTPC will be dissolved upon expiration of the Transition Period.
5.1.2.Membership. The JTPC will consist of an equal number of representatives from each Party and no fewer than [***] from each Party, [***]. JTPC members shall have such expertise as appropriate to the activities of the JTPC from time to time and the JTPC shall invite personnel of the Parties having relevant expertise to participate in discussions of the JTPC from time to time as appropriate to assist in the activities of the JTPC. The Parties shall appoint Co-Chairs in accordance with Section 5.4 (Co-Chairs).
5.1.3.Responsibilities. The JTPC shall oversee the implementation of the Transition Plan, and shall have solely the roles and responsibilities assigned to it in this Section 5.1.3 (Responsibilities) and as otherwise expressly set forth in this Agreement. The JTPC shall not have the authority to: (i) modify or amend the terms and conditions of this Agreement; or (ii) waive either Party’s compliance with the terms of this Agreement. The JTPC shall be responsible, subject to Section 5.3 (Decision-Making), for:
(a)providing a forum for the discussion of and coordinating the Parties’ activities under the Transition Plan;
(b)reviewing the Transition Plan on an ongoing basis and discussing and agreeing in writing on updates or amendments to the Transition Plan from time to time;
(c)overseeing the implementation of the Transition Plan and any related issues; and
(d)performing such other activities as are expressly allocated to the JTPC under this Agreement.
5.2.Meetings. The JTPC will meet at such frequency as shall be established by the Parties, but not less frequently than [***] unless otherwise mutually agreed by the Parties. Each Party shall have also the right to convene additional JTPC meetings upon reasonable prior
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written notice to the other Party. Meetings may be held telephonically or by video conference or at the offices of the Parties as determined by the JTPC. All meetings will be conducted in English. With the consent of the Parties (not to be withheld unreasonably), [***]. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JTPC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative subject to prior notification to the other Party. The minutes of JTPC meetings shall provide a description in reasonable detail of the discussions held at the meeting and a list of any actions, decisions or determinations approved by the JTPC. Minutes of the JTPC meeting shall be approved or disapproved, and revised as necessary, at the next meeting.
5.3.Decision-Making.
5.3.1.In order to make any decision required of it hereunder with respect to any approval, the JTPC must have present (in person, by videoconference or telephonically) at least the Co-Chair of each Party (or his/her designee for such meeting). The Parties will endeavor to make decisions [***].
5.3.2.If the JTPC is unable to agree on any matter within the scope of its authority, within [***] after such matter was first referred to it, then [***] shall attempt in good faith to resolve such dispute or failure to agree. If the Executive Officers are unable to agree on any such matter within [***] after such matter was first referred to them, [***]; provided that, subject to Section 5.3.3 (Decision-Making), any amendment or update to the Transition Plan that would (a) extend the Transition Period or the length of an activity to be provided thereunder, or (b) increase the resources to be expended by Black Diamond under the Transition Plan, in each case ((a) and (b)), [***]. Section 13.1.2 (Dispute Resolution) shall otherwise apply.
5.3.3.Black Diamond may not refuse its consent to include an activity or service to be performed by Black Diamond or its contractors (subject to the terms and agreements of the respective Third Party agreement) into the Transition Plan, if such activity or service is reasonably required for the transfer of the INDs or is reasonably required by Servier to resume the Ongoing Phase 1 Clinical Trial, provided that [***].
5.4.Co-Chairs. Each Party shall appoint [***] of its members to co-chair the JTPC’s meetings (each, a “Co-Chair”). The Co-Chairs shall (a) ensure the orderly conduct of the JTPC’s meetings, (b) attend each JTPC meeting (either in-person, by videoconference or telephonically, unless otherwise expressly provided herein), and (c) prepare and issue written minutes of each meeting within [***] thereafter accurately reflecting the discussions and decisions of such meeting. In the event the Co-Chair from either Party is unable to attend or participate in a JTPC meeting, the Party who designated such Co-Chair may designate a substitute Co-Chair for the meeting in its sole discretion.
5.5.Alliance Managers. Promptly after the Effective Date, each of Servier and Black Diamond shall appoint a senior representative who possesses a general understanding of research, manufacture and development matters to act as its respective alliance manager (each, an “Alliance Manager”). Each Party may replace its respective Alliance Manager at any time upon written notice to the other in accordance with another senior representative with appropriate qualification. The Alliance Managers shall participate in the JTPC’s meetings. The Alliance Managers shall be responsible for providing a primary point of communication between the Parties.
5.6.Costs. The Parties agree that the costs incurred by [***], under this Article 5 shall be borne solely by such Party.
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6.DATA PROTECTION.
6.1.Data Processing. Each Party is processing business contact details such as the name, email address, phone number (“Business Contact Data”) of the other Party’s employees and attendants (“Business Contact(s)”). The Parties process these Business Contact Data as separate data controllers for the purposes and legal basis described hereinafter:
•Management of the contractual relationship and performance of the Agreement (e.g., negotiation, signature, follow up the performance of the Agreement) based on their legitimate interests which are to facilitate the negotiation and performance of the Agreement;
•Accounting management based on Servier’s legal obligations;
•Compliance with legal and regulatory requirements as well as applicable recommendations, based on Servier’s legal and regulatory obligations or Servier’s legitimate interests which are to comply with any guidelines applicable to pharmaceutical industries.
6.1.1.Each Party may share, under its responsibility, the Business Contact Data with its employees or attendants, as well as its affiliates, if applicable, which are all duly authorized to process these Business Contact Data. The Parties may also provide the Business Contact Data to data processors if need be and competent authorities pursuant to a legal, judicial or regulatory request. In case of transfer of Business Contact Data outside of the European Union in a country that is not recognized as offering an adequate level of protection by the European Commission, the Parties will implement appropriate guarantees to ensure that this processing complies with the applicable legal and regulatory framework.
6.1.2.The Parties warrant that their own Business Contact Data has been and will be obtained and/or disclosed in compliance with applicable data protection regulation requirements. They also commit to use and process the Business Contact Data of the other Party in compliance with these requirements. Therefore, each Party undertakes to (i) implement technical and organizational measures to ensure the protection of these Business Contact Data against any unauthorized access as well as against any breach, loss, unauthorized disclosure or accidental destruction, and (ii) notify the other Party, without undue delay, if any of these hypotheses occurs.
6.1.3.Each Party shall retain the Business Contact Data for a period of time that is no longer than is necessary for the purposes for which the personal data are processed increased by the relevant statutory limitations to fulfil the above-mentioned purposes.
6.1.4.Business Contacts may have rights granted under the applicable data protection regulation such as the right to access, rectify, erase, restrict the processing and object to the processing. To exercise any of their rights, they may send an email to the contact in charge of data protection:
•For Servier at: [***]; or
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•For Black Diamond at the address to be provided by Black Diamond following the Effective Date.
6.1.5.In the event that the Party does not answer to the Business Contact, the latter may also lodge a complaint with the competent supervisory authority.
6.1.6.
6.2.Data Processing Agreement. Promptly following the Effective Date, if and to the extent required by Applicable Laws, the Parties, or their respective Affiliates, will enter into a data protection agreement containing appropriate provisions in respect of the sharing of personal data between the Parties, or their respective Affiliates, which upon such execution will be attached as an exhibit hereto and hereby incorporated into this Agreement by reference (the “Data Protection Agreement”). No personal data, except for the Business Contact Data necessary for the negotiation and performance of the Agreement subject to the terms of Section 6.1 (Data Processing), will be shared between the Parties, or their respective Affiliates, prior the signature of the Data Protection Agreement. The Parties undertake to comply with the provisions of the Data Protection Agreement.
7.CONSIDERATION.
7.1.Upfront Payment. In partial consideration for the rights granted by Black Diamond to Servier under this Agreement, within [***] after the Effective Date and receipt of an invoice from Black Diamond, Servier will pay to Black Diamond a one-time, non-refundable, non-creditable cash payment of seventy million U.S. dollars (USD 70,000,000).
7.2.Milestones.
7.2.1.Development and Regulatory Milestones. Servier will pay to Black Diamond the following one-time, non-refundable, non-creditable cash milestone payments in the amounts set forth in the table below (each, a “Development and Regulatory Milestone Payment”) upon achievement of the respective milestone event set out in the table below (each, a “Development and Regulatory Milestone Event”).
| Development and Regulatory Milestone Event | Development and Regulatory Milestone Payment (in U.S. dollars (USD)) |
|---|---|
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
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| Development and Regulatory Milestone Event | Development and Regulatory Milestone Payment (in U.S. dollars (USD)) |
|---|---|
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
| Total Development Milestones | [***] |
7.2.2.* If Servier conducts a [***].
7.2.3.Each Development and Regulatory Milestone Payment [***]. The maximum amount payable by Servier under this Section 7.2.1 (Development and Regulatory Milestones) if all Development and Regulatory Milestone Events occur (regardless of the number of times they occur or the number of Licensed Products that trigger them) is [***].
7.2.4.Servier will notify Black Diamond of the achievement of each Development and Regulatory Event within [***] following the achievement of such Development and Regulatory Event. Servier will make the corresponding Development and Regulatory Milestone Payment to Black Diamond within [***] following receipt of a corresponding invoice from Black Diamond.
7.2.5.Sales Milestones. Servier will pay to Black Diamond the following one-time, non-refundable, non-creditable sales-related milestone payments in the amounts set forth in the table below (each, a “Sales Milestone Payment”) upon [***] as set out in the table below (each, a “Sales Milestone Event”) during the Royalty Term.
| Sales Milestones Event | Sales Milestones Payments (in U.S. dollars (USD)) |
|---|---|
| [***] | [***] |
| [***] | [***] |
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| Sales Milestones Event | Sales Milestones Payments (in U.S. dollars (USD)) |
|---|---|
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
| Total Sales Milestones Payment | [***] |
7.3.Each of the Sales Milestone Payments shall be paid [***]. The maximum amount payable by Servier under this Section 7.2.2 (Sales Milestones) if all Sales Milestone Events occur [***]. For the avoidance of doubt, Net Sales in a country where the Royalty Term has expired shall not be included for purposes of calculating Sales Milestone Events.
7.4.Servier will notify Black Diamond of the achievement of each Sales Milestone Event within [***] in which the respective Sales Milestone Event is achieved. Servier will make the corresponding Sales Milestone Payment to Black Diamond within [***] following receipt of a corresponding invoice from Black Diamond.
7.5.Royalties. During the Royalty Term, Servier shall pay to Black Diamond the royalties on Net Sales, on a country-by-country and Licensed Product-by-Licensed Product basis, as set forth in this Section 7.3 (Royalties). For purposes of this Section 7.3 (Royalties), [***].
7.5.1.Royalty Payments. Subject to the provisions of Section 7.3.3 (Adjustments in Royalty Rates), Servier will pay Black Diamond tiered royalties at the following royalty rates (the “Royalty Rates”) based on [***] (the “Annual Net Sales”).
| Annual Net Sales of Licensed Product | Royalty Rate (in % of Annual Net Sales) |
|---|---|
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
| [***] | [***] |
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| Annual Net Sales of Licensed Product | Royalty Rate (in % of Annual Net Sales) |
|---|---|
| [***] | [***] |
| [***] | [***] |
7.5.2.Royalty Term. Servier’s obligation to make royalty payments shall, on a country-by-country and Licensed Product-by-Licensed Product basis, commence on the First Commercial Sale of such Licensed Product in such country and shall expire upon the later to occur of: (a) the expiration of the last Valid Claim of an Exclusive Licensed Patent Right Covering such Licensed Product in such country; (b) the date that is [***] from the First Commercial Sale of such Licensed Product in such country; and (c) the expiration of all Regulatory Exclusivity for such Licensed Product in such country (“Royalty Term”).
7.5.3.Adjustments in Royalty Rates.
(a)Third Party Patents. If Servier obtains rights to one or more Patent Rights from a Third Party that are necessary (i.e., blocking) to Develop, Manufacture or Commercialize the Licensed Compound or Licensed Product in a country in the Territory (each such Third Party license referred to herein as an “Additional Third Party License”), then, subject to Section 7.3.3(e) (Cumulative Royalty Reductions), Servier may deduct [***] of any payments paid to such Third Party under such Additional Third Party License from the royalties payable to Black Diamond under this Agreement.
(b)No Patent Right Coverage. On a country-by-country and Licensed Product-by Licensed Product basis, in the event that, in a given country of the Territory, the sale of the Licensed Product in such country is no longer Covered by any Valid Claim of an Exclusive Licensed Patent Right in such country of sale, then subject to Section 7.3.3(e) (Cumulative Royalty Reductions), the Royalty Rate payable to Black Diamond under this Agreement with respect to such Licensed Product in such country shall be reduced by [***].
(c)Generic Competition.
(i)On a country-by-country and Licensed Product-by Licensed Product basis, if a Generic Product is launched in a given country prior to the end of the Royalty Term and following such launch, the Net Sales of such Licensed Product decrease in a [***] by [***] or more as compared to the Net Sales of such Licensed Product in the [***] immediately prior to such Generic Product’s launch in such country, then, subject to Section 7.3.3(e) (Cumulative Royalty Reductions), the Royalty Rate owed by Servier to Black Diamond will be reduced by [***] in such country.
(ii)On a country-by-country and Licensed Product-by Licensed Product basis, if, following such Generic Product entry, the Net Sales of the applicable Licensed Product in a [***] decrease by more than [***] as compared to the Net Sales of such Licensed Product in the [***] immediately prior to such Generic Product’s launch in such country, then the Royalty Rate owed by Servier to Black Diamond will, subject to Section 7.3.3(e) (Cumulative Royalty Reductions), be reduced by [***] in such country.
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(d)Inflation Reduction Act. With respect to the calculation of royalties in the United States, if the Licensed Product becomes eligible for drug price negotiation under the Inflation Reduction Act, then, subject to Section 7.3.3(e) (Cumulative Royalty Reductions), the applicable Royalty Rates for the Net Sales of such Licensed Product in the United States shall be reduced by a percentage equal to [***].
(e)Cumulative Royalty Reductions. In no event will the royalties due to Black Diamond in any [***] with respect to any Licensed Product in the Field in the Territory be reduced by more [***] as a result of the reductions contemplated by Section 7.3.3(a) (Third Party Patents), Section 7.3.3(b) (No Patent Right Coverage), Section 7.3.3(c) (Generic Competition), and Section 7.3.3(d) (Inflation Reduction Act); provided that, (i) if, during the applicable Royalty Term both of the reductions set forth in Section 7.3.3(b) (No Patent Right Coverage) and Section 7.3.3(c)(i) (Generic Competition) apply, then such floor will be lowered to [***] of the amount that would otherwise be due to Black Diamond during such period, and (ii) if, during the applicable Royalty Term, the reduction set forth in Section 7.3.3(c)(ii) (Generic Competition) applies, then such floor will be lowered to [***] of the amount that would otherwise be due to Black Diamond during such period, and (iii) any reduction not fully taken as a result of the application of the foregoing royalty floor may be carried forward into any subsequent [***] and applied against future royalties otherwise owed to Black Diamond for the applicable Licensed Product, but subject in all cases to the royalty floor set forth in this Section 7.3.3(e) (Cumulative Royalty Reductions).
7.5.4.Fully Paid-Up, Royalty Free License. Following the expiration of the Royalty Term for the Licensed Product in a given country of the Territory, no further royalties shall be payable in respect of the Licensed Product in such country and, thereafter, the license granted to Servier under Section 2.1 (License to Servier) with respect to the Licensed Product in such country shall automatically become fully paid-up, perpetual, irrevocable and non-terminable.
7.6.Reports and Payments.
7.6.1.Royalty Reports. Within [***] after the end of each [***], beginning with the [***] in which the First Commercial Sale of a Licensed Product is made in a country following receipt of Regulatory Approval for such Licensed Product in such country, Servier shall deliver to Black Diamond a report that includes [***]. The total royalty due for the sale of Licensed Products during such [***] shall be remitted at the time such report is made. No such reports shall be due for the Licensed Product after the relevant Royalty Term has expired.
7.6.2.Taxes and Withholding.
(a)General. Subject to Section 7.4.2(b) (Withholding Taxes), the amounts payable pursuant to this Agreement (“Payments”) will not be reduced on account of any taxes unless required by Applicable Law. Except as expressly set forth in this Agreement, each Party will be responsible for all taxes imposed on such Party’s net income, or on net income allocated to such Party under Applicable Law, and to the extent one Party pays taxes imposed on net income of the other Party, the other Party will reimburse the paying Party for any such taxes paid.
(b)Withholding Taxes. Notwithstanding the foregoing Section 7.4.2(a) (General), Servier shall be entitled to deduct and withhold from any Payment the amount of any withholding tax required under Applicable Laws, in which case such amount shall be treated for purposes of this Agreement as having been paid to the Person in respect of whom such withholding was made.
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(c)VAT. It is understood and agreed between the Parties that any payments made under this Agreement are exclusive of any value added or similar tax (“VAT”), which will be added thereon as applicable.
(d)Tax Cooperation. To the extent Servier is required to deduct and withhold taxes on any payments to Black Diamond, Servier will pay the amounts of such taxes to the proper Governmental Authority in a timely manner and promptly transmit to Black Diamond an official tax certificate or other evidence of such withholding sufficient to enable Black Diamond to claim such payments of taxes. Black Diamond will provide to Servier any tax forms that may be necessary in order for Servier not to withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty. Each Party will provide the other with reasonable assistance to enable the recovery, as permitted by Applicable Law, of withholding taxes, VAT, or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party bearing such withholding tax or VAT. The Parties agree to cooperate and produce on a timely basis any tax forms or reports reasonably requested by the other Party in connection with any payment made by Servier to Black Diamond under this Agreement.
(e)Tax Action. Notwithstanding anything to the contrary in this Agreement, if Servier (or its assignee) redomiciles or assigns its rights or obligations under this Agreement, or fails to comply with applicable Laws or filing or record retention requirements, or there is a change in the party making payment (each, a “Tax Action”), and, as a result of such Tax Action, the amount of tax required to be withheld under this Section 7.4.2 (Taxes and Withholding) in respect of a payment to Black Diamond is greater than the amount of such tax that would have been required to have been withheld absent such Tax Action, then any such amount payable to Black Diamond will be adjusted to take into account such withholding taxes as may be necessary so that, after making all required withholdings or deductions (as adjusted for any refunds pursuant to Section 7.4.2 (Taxes and Withholding)), Black Diamond receives an amount equal to the sum it would have received had no such Tax Action occurred. For purposes of this Section 7.4.2 (Tax Action), a “redomiciliation” shall mean a reincorporation, acquisition transaction or other action resulting in a change in tax residence of Servier or its assignee. For the avoidance of doubt, if Black Diamond (or its assignee) redomiciles or assigns its rights or obligations under this Agreement, or fails to comply with Applicable Laws or filing or record retention requirements, or there is a change in the party receiving payments, then (a) Servier shall not be liable for a failure to comply with Section 7.4.2(d) (Tax Cooperation), to the extent that Black Diamond’s actions resulted in such inability to comply, and (b) Black Diamond shall reimburse Servier for any reasonable and documented increased costs actually incurred by Servier and its Affiliates under Section 7.4.2(d) (Tax Cooperation).
7.6.3.Currency. All amounts payable and calculations hereunder shall be in United States dollars. As applicable, Net Sales and any royalty deductions shall be translated into United States dollars in accordance with the Wall Street Journal applicable conversion procedures, consistently applied. If, due to restrictions or prohibitions imposed by national or international authority, payments cannot be made as provided in this Section 7 (Consideration), the Parties shall consult with a view to finding a prompt and acceptable solution, and the paying Party shall deal with such monies as the other Party may lawfully direct at no additional costs to the paying Party.
7.6.4.Method of Payment. Except as permitted pursuant to Section 7.4.3 (Currency), each payment hereunder shall be made by electronic transfer in immediately available funds via a bank wire transfer, an automated clearing house (ACH) mechanism or any
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other means of electronic funds transfer, at the paying Party’s election, to the bank account designated by the Party receiving payments under this Article 7 (Consideration) in writing to the paying Party at least [***] before the payment is due. Such account shall be in the name of the Party receiving payments in a bank located in the country in which such Party is incorporated. In addition, except as otherwise set forth herein, all payments due hereunder will be payable within [***] following receipt of an invoice requesting such payment.
7.6.5.Record Keeping. Servier shall keep, and shall cause its Affiliates and Sublicensees to keep, books and accounts of record in connection with the sale of Licensed Products, including records of gross invoiced sales, Net Sales, exchange rates and royalty payments (collectively, the “Financial Records”), in accordance with the Accounting Standards and in sufficient detail to permit accurate determination of all figures necessary for verification of royalties and Sales Milestone Payments to be made by Servier under this Article 7 (Consideration). Servier and its Affiliates and Sublicensees shall maintain such records for a period of at least [***] after the end of the [***] in which they are generated.
7.6.6.Audits. Upon [***] prior written notice from Black Diamond, Servier shall permit an independent certified public accounting firm of nationally recognized standing selected by Black Diamond and reasonably acceptable to Servier, to examine, [***], the relevant Financial Records of Servier and its Affiliates and Sublicensees as may be reasonably necessary to verify the amounts reported by Servier in accordance with Section 7.4.1 (Royalty Reports) and the royalties and Sales Milestone Payments made by Servier in accordance with this Article 7 (Consideration). Black Diamond shall be entitled to conduct an audit in accordance with this Section 7.4.6 (Audits) not more than [***] in any [***] and such audit shall be limited to the pertinent Financial Records from any [***] ending not more than [***] prior to the date of the request. The accounting firm shall be provided access to such Financial Records at Servier’s facility(ies) where such Financial Records are normally kept and such audit shall be conducted during Servier’s normal business hours. Upon completion of the audit, the accounting firm shall provide both Parties with a written report disclosing any discrepancies in the reports submitted by Servier or payments made by Servier, if any, and in each case, the specific details concerning any discrepancies. Any information provided by Servier to the accounting firm and the written report of the accounting firm shall be the Confidential Information of Servier.
7.6.7.Underpayments/Overpayments. If a report of an independent public accounting firm submitted to the Parties in accordance with Section 7.4.6 (Audits) shows any underpayment of royalties or Sales Milestone Payments due under this Article 7 (Consideration), then Servier shall remit to Black Diamond within [***] after receipt of such report by Servier, the amount of such underpayment. Additionally, if such independent public accounting firm’s written report shows an [***], then Servier shall reimburse Black Diamond for its documented and reasonable [***], which reimbursement will be made within [***] after receiving an invoice. If such independent public accounting firm’s written report shows any overpayment of royalties and Sales Milestone Payments due under this Article 7 (Consideration), Servier shall receive a credit equal to such overpayment against the royalties and Sales Milestone Payments due under this Article 7 (Consideration) otherwise payable to Black Diamond. If a Party disagrees with the report of the independent public accounting firm submitted to the Parties in accordance with Section 7.4.6 (Audits), Section 13.1.2 (Dispute Resolution) shall apply.
7.6.8.Interest. Any payment under this Agreement that is past due shall be subject to interest at an annual percentage rate of [***].
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8.CONFIDENTIALITY.
8.1.Confidential Information. Except to the extent expressly permitted by this Agreement and subject to the provisions of Section 8.2 (Authorized Disclosure), at all times during the Term and for [***] following the expiration or termination hereof, each Party (the “Receiving Party”) receiving any Confidential Information of the other Party (the “Disclosing Party”) in connection with this Agreement shall: (a) keep confidential and shall not publish or otherwise disclose any Confidential Information furnished to it by the Disclosing Party, except to those of the Receiving Party’s Representatives who have a need to know such information that are subject to a confidentiality agreement at least as restrictive as the terms set forth in this Article 8 (Confidentiality) (collectively, “Recipients”) to perform such Party’s obligations or exercise its rights hereunder, and (b) not use Confidential Information of the Disclosing Party directly or indirectly for any purpose other than performing its obligations or exercising its rights hereunder. The Receiving Party shall be liable for any breach by any of its Recipients of the restrictions set forth in this Agreement.
8.2.Authorized Disclosure. Notwithstanding the provisions of Section 8.1 (Confidential Information), the Receiving Party and its Recipients may disclose Confidential Information belonging to the Disclosing Party to the extent that such disclosure is reasonably necessary to:
8.2.1.prosecute or defend litigation as permitted under this Agreement;
8.2.2.comply with Applicable Law or the requirements of a national securities exchange or another similar Regulatory Authority;
8.2.3.be disclosed to any bona fide potential or actual licensee, acquirer, merger partner or investor to evaluate or carry out an actual or potential financing (including a royalty monetization) or Change of Control; provided that (a) prior to such disclosure, the Disclosing Party shall inform each recipient of the confidential nature of such Confidential Information, (b) any such disclosure shall be subject to confidentiality obligations that are no less stringent than the confidentiality provisions contained in this Agreement, and (c) each such recipient may only use such Confidential Information for the sole purpose of evaluating or carrying out the actual or potential financing or Change of Control;
8.2.4.make filings and submissions to, or correspond or communicate with, any Governmental Authority (including INDs and submissions to obtain Regulatory Approvals) in relation to the Licensed Patent Rights or Licensed Products;
8.2.5.file, prosecute and defend Patent Rights as permitted under this Agreement; or
8.2.6.for regulatory purposes to the extent such disclosure is required to obtain or maintain Regulatory Approvals.
In the event that the Receiving Party or its Recipients, as applicable, deem it reasonably necessary to disclose Confidential Information belonging to the Disclosing Party pursuant to this Section 8.2 (Authorized Disclosure), the Receiving Party shall, unless prohibited by Applicable Law, provide the Disclosing Party with reasonable advance notice of such disclosure and take reasonable measures, such as a protective order, to ensure confidential treatment of such information and narrowing the scope of such use or disclosure. For clarification, any such limited disclosure shall not cause any such information to cease to be Confidential Information.
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8.3.Notification. The Receiving Party shall notify the Disclosing Party [***] and cooperate with the Disclosing Party as the Disclosing Party may reasonably request, upon the Receiving Party’s discovery of any loss or compromise of the Disclosing Party’s Confidential Information.
8.4.Use of Name; Publicity.
8.4.1.Except as set forth in this Section 8.4 (Use of Name; Publicity), each Party shall keep the existence of, the terms of and the transactions covered by this Agreement confidential and shall not disclose such information to any Third Party through a press release or otherwise, or mention or otherwise use the name, insignia, symbol, trademark, trade name or logotype of the other Party or its Affiliates in any manner without the prior written consent of the other Party in each instance (which shall not be unreasonably withheld). The restrictions imposed by this Section 8.4 (Use of Name; Publicity) shall not prohibit either Party from making any disclosure that is required by Applicable Law, rule or regulation or the requirements of a national securities exchange or another similar regulatory body, including disclosing such information in any Clinical Trial database maintained by or on behalf of a Party, or that is expressly permitted under this Agreement subject to the provisions of Section 8.2 (Authorized Disclosure). Further, the restrictions imposed on each Party under this Section 8.4 (Use of Name; Publicity) are not intended, and shall not be construed, to prohibit a Party from identifying the other Party in its internal business communications, provided that any Confidential Information in such communications remains subject to this Section 8.4 (Use of Name; Publicity).
8.4.2.It is understood that the Parties will issue a joint press release announcing the execution of this Agreement in the form set out in Schedule 8.4.2 (Press Release). Subject to Section 8.4.1 and Section 8.4.3, any subsequent press releases by Black Diamond relating to the Agreement or the activities hereunder requires the prior written consent by Servier, such consent not to be unreasonably withheld.
8.4.3.After a presentation, publication or the issuance of a press release or other public announcement permitted under this Section 8.4 (Use of Name; Publicity), either Party may make subsequent public disclosures reiterating such information without having to obtain the other Party’s prior consent and approval so long as the information in such press release or other public announcement remains true, correct, and the most current information with respect to the subject matters set forth therein, including after a publication has been made available to the public, each Party may post such publication or a link to it on its corporate website or social media platforms (or any website managed by such Party in connection with a Clinical Trial for the Licensed Product, as appropriate) without the prior written consent of the other Party, so long as the information in such publication remains true, correct, and the most current information with respect to the subject matters set forth therein.
8.5.Publications. Following the Effective Date, Servier shall have the sole right to publish peer reviewed manuscripts, or otherwise publicly disclose results of studies carried out in respect of the Licensed Compound or Licensed Product, without the consent of Black Diamond.
8.6.Remedies. The Parties acknowledge and agree that the restrictions set forth in Section 8 (Confidentiality) are reasonable and necessary to protect the legitimate interests of the Parties and that neither Party would have entered into this Agreement in the absence of such restrictions, and that any breach or threatened breach of any provision of Article 8 (Confidentiality) may result in irreparable injury to the other Party for which there will be no adequate remedy at law. In the event of a breach or threatened breach of any provision of Article 8 (Confidentiality) by a Party, [***].
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9.REPRESENTATIONS AND WARRANTIES.
9.1.Representations and Warranties of Each Party. Each Party represents and warrants to the other as of the Effective Date that: (a) it is duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization; (b) the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite action under the provisions of its charter, bylaws and other organizational documents, and does not require any action or approval by any of its shareholders or other holders of its voting securities or voting interests; (c) it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder; (d) this Agreement has been duly executed and is a legal, valid and binding obligation on each Party, enforceable against such Party in accordance with its terms; and (e) the execution, delivery and performance by such Party of this Agreement and its compliance with the terms and provisions hereof does not and will not conflict with or result in a breach of or default under any binding arrangement or agreement with a Third Party existing as of the Effective Date, nor violates any Applicable Law as of the Effective Date.
9.2.Additional Representations and Warranties of Black Diamond. Black Diamond hereby represents and warrants the following to Servier as of the Effective Date:
9.2.1.Intellectual Property
(a)Black Diamond is the sole legal and beneficial owner of the entire right, title and interest in the Licensed Technology.
(b)The Licensed Technology is not subject to any encumbrance or lien or to any claim of ownership by any Third Party and there are no judgements or settlements in effect against Black Diamond relating to the Licensed Technology in the Territory.
(c)The Licensed Patent Rights listed in Schedule 1.81 constitute a true and complete list of all Patent Rights owned or otherwise Controlled by Black Diamond that are necessary or useful for the Development, Manufacture, or Commercialization of the Licensed Compound and the Licensed Product.
(d)To Black Diamond’s knowledge, the Development, Manufacture and Commercialization of the Licensed Product in the Territory does not infringe or misappropriate the Intellectual Property Rights of any Third Party and there is no claim or litigation brought or threatened by written notice to Black Diamond by any Person making such allegations.
(e)No Licensed Patent Rights are issued in the Territory, and all Licensed Patent Rights are currently pending.
(f)The Licensed Patent Rights have been properly filed and diligently prosecuted and maintained in accordance with Applicable Laws and all applicable fees have been paid on or before the due date for payment.
(g) (i) The Licensed Patent Rights properly identify each and every inventor of the claims of the Licensed Patent Rights, and (ii) Black Diamond has obtained from all inventors of Licensed Patent Rights valid and enforceable agreements assigning to Black Diamond each such inventor’s entire right, title and interest in and to all such Licensed Patent Rights or Licensed Know-How. Black Diamond and its Affiliates have made all payments owing to any inventor of any Licensed Technology owned by Black Diamond or such Affiliate that is required in connection with the
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creation or exploitation of or transfer of rights to such Licensed Technology under Applicable Law.
(h)There is no pending, or to Black Diamond’s knowledge, threatened, litigation that seeks to invalidate or challenge the ownership or validity of any of the Licensed Patent Rights set forth on Schedule 1.81 (Licensed Patent Rights), and no Third Party has challenged in writing, or, to the knowledge of Black Diamond, has threatened in writing to challenge, Black Diamond’s ownership of, right to use and license the Licensed Know-How.
(i)Where Licensed Know-How has been disclosed to a Third Party under terms of confidentiality, to Black Diamond’s knowledge, no breach of such confidentiality obligations has been committed by any such Third Party. Black Diamond has taken reasonable precautions to preserve the confidentiality of the Licensed Know-How.
(j)To Black Diamond’s knowledge, no Third Party is infringing or misappropriating any of the Licensed Patents Rights or the Licensed Know-How.
9.2.2.Third Party Agreements
(a)There are no in-license or other agreements with any Third Party pursuant to which Black Diamond Controls any of the Licensed Patent Rights.
(b)All Assigned Contracts are in full force and effect and have not, to Black Diamond’s knowledge, been breached. Black Diamond has no knowledge of any circumstances that may lead to a claim of breach under such agreements. Without limiting the foregoing, Black Diamond has not received any written notices from any counterparty under any Assigned Contract notifying Black Diamond of any intention of such counterparty to terminate the applicable Assigned Contract.
9.2.3.Regulatory and Compliance
(a)To Black Diamond’s knowledge, the Ongoing Phase 1 Clinical Trial can be resumed without regulatory requirements other than IND transfer to Servier in the United States.
(b)There are no material investigations, inquiries, actions, or other proceedings pending before or, to Black Diamond’s knowledge, threatened by any Regulatory Authority or other Governmental Authority with respect to any Licensed Product or Licensed Compound arising from any violation of Applicable Law by Black Diamond or a Third Party acting on behalf of Black Diamond in the Development or Manufacture of a Licensed Product or Licensed Compound, and Black Diamond has not received written notice threatening any such investigation, inquiry, action, or other proceeding.
(c)The Development and Manufacture of the Licensed Compound and Licensed Products prior to the Effective Date has been conducted in all material respects with all Applicable Laws, including cGMP, GLP and GCP.
(d)In the course of the Development of the Licensed Compound and Licensed Products, Black Diamond has not, to its knowledge, used any
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employee or consultant that is debarred by any Regulatory Authority or is the subject of debarment proceedings by any Regulatory Authority.
(e)Neither Black Diamond nor any of its Affiliates is engaged in any litigation, opposition or arbitration related to the Licensed Products and, to Black Diamond’s knowledge, there are no such litigation, opposition or arbitration proceedings pending or threatened by written notice to Black Diamond.
(f)The rights granted to Servier under this Agreement are not subject to any right, license or interest under the Licensed Patent Rights in favor of any government due to funding obtained with respect to Licensed Compounds or Clinical Trials carried out in government owned hospitals which would conflict with the rights granted to Servier under this Agreement.
(g) No information or documentation provided by Black Diamond to Servier as part of the due diligence process contain any untrue or misleading statement of a material fact.
9.3.Representation by Legal Counsel. Each Party hereto represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting. In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption shall exist or be implied against the Party which drafted such terms and provisions.
9.4.No Inconsistent Agreements. Neither Party has in effect, and after the Effective Date neither Party shall enter into, any oral or written agreement or arrangement that would be inconsistent with its obligations under this Agreement or limit the ability of either Party to grant the licenses set forth in Article 2 (Grants of Licenses) of this Agreement.
9.5.Mutual Covenants.
9.5.1.Compliance with Law. Each Party hereby covenants and agrees to comply and to procure that its Affiliates and its/their subcontractors comply, with all Applicable Law in performing its activities under this Agreement. Without limiting the generality of the foregoing:
9.5.2.Export Controls and International Sanctions. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries which may be imposed upon or related to Black Diamond or Servier from time to time. Each Party agrees that it shall not export, directly or indirectly, any technical information acquired from the other Party pursuant to this Agreement or any Licensed Compounds or Licensed Products using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the appropriate agency or other governmental entity. It also warrants that it will not, for the performance of the Agreement, interact with any Third Parties who are subject to Sanctions. Each Party undertakes to inform the other Party immediately of any change in the above declarations which could have an impact on their compliance with Export Control Laws and Sanctions.
9.5.3.Anti-Bribery. Each Party (a) will comply with all Applicable Laws concerning bribery, money laundering, or corrupt practices or which in any manner prohibit the giving of anything of value to any official, agent, or employee of any government, political party, or public international organization, candidate for public office, health care professional,
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or to any officer, director, employee, or representative of any other organization and the U.S. Foreign Corrupt Practices Act, and the U.K. Bribery Act and the French Sapin II Law on transparency, prevention of corruption and the modernization of economic life, in each case, in connection with the activities conducted pursuant to this Agreement, and will require, with respect to agreements entered into after the Effective Date, any contractors, subcontractors, distributors, or other Person that provide services to such Party in connection with this Agreement to comply with such Party’s obligations under this Section 9.5.3 (Anti-Bribery); and (b) will not, with respect to any activities conducted under this Agreement, (i) commit an act, (ii) make a statement, or (iii) fail to act or make a statement, in any case ((i), (ii), or (iii)), that (A) would be or create an untrue statement of material fact or fraudulent statement to the FDA or any other Regulatory Authority with respect to the exercise of the rights granted hereunder, or (B) could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto or any analogous laws or policies in any country in the Territory, with respect to the exercise of the rights granted hereunder.
9.5.4.Debarment. Each Party agrees that it shall not knowingly use, in any capacity, in connection with any of its obligations to be performed under this Agreement any individual who has been disqualified or debarred by the United States Food and Drug Administration, pursuant to 21 U.S.C. §§ 335(a) or (b), or been charged with or convicted under United States law for conduct relating to the development or approval, or otherwise relating to the regulation of Licensed Product under the Generic Drug Enforcement Act of 1992, or any other relevant law, rule, or regulation or been disbarred, disqualified, or convicted under or for any equivalent or similar applicable foreign law, rule, or regulation.
9.6.Disclaimer. NEITHER PARTY MAKES ANY EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, ALL OTHER REPRESENTATIONS AND WARRANTIES WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE ARE EXPRESSLY DISCLAIMED, INCLUDING ANY REPRESENTATION OR WARRANTY REGARDING THE VALIDITY OR SCOPE OF ITS PATENT RIGHTS, THAT THE MANUFACTURE, USE OR SALE OF THE LICENSED COMPOUNDS OR LICENSED PRODUCTS WILL NOT INFRINGE THE PATENT RIGHTS OF THIRD PARTIES, OR ANY REPRESENTATION OR WARRANTY AS TO THE VALUE, ADEQUACY, FREEDOM FROM FAULT OF, OR QUALITY, EFFICIENCY, CHARACTERISTICS OR USEFULNESS OF, OR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF ANY LICENSED COMPOUND OR LICENSED PRODUCT.
10.INTELLECTUAL PROPERTY.
10.1.Background IP. Subject only to the rights expressly granted to the other Party under this Agreement, each Party shall retain all rights, title and interests in and to any Intellectual Property Rights that are owned by, licensed or sublicensed to such Party prior to the Effective Date or developed by a Party independently of this Agreement.
10.2.Inventorship. All determinations of inventorship under this Agreement will be made in accordance with U.S. patent law.
10.2.1.Inventions. Subject to Section 10.1 (Background IP), (a) each Party will own all rights, title, and interests in and to (i) any and all Know-How developed or invented solely by or on behalf of such Party or its Affiliates in connection with the performance of such Party’s activities under this Agreement and (ii) any and all Patent Rights claiming any such Know-How described in clause (a)(i) of this Section 10.2.1 (Inventions), and
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(b) Servier will own (i) any and all Know-How developed or invented jointly by or on behalf of the Parties or their Affiliates in connection with the performance of the Party’s activities under this Agreement and (ii) any and all Patent Rights claiming any such Know-How described in clause (b)(i) of this Section 10.2.1 (Inventions) (any Intellectual Property Rights owned by Servier pursuant to the foregoing (a) and (b), the “Servier Foreground IP”). [***].
10.3.Filing, Prosecution and Maintenance of Patent Rights.
10.3.1.[***] Right to File and Prosecute [***]. Following the Effective Date, [***] will have the first right to, and be responsible for, control of the filing, prosecuting (including in connection with any reexaminations, oppositions, and the like), and maintaining the [***]. [***] may use patent counsel of its own choice and will be responsible for all costs and expenses in connection with such filing, prosecution, and maintenance. [***] will provide [***] a reasonable opportunity to review and provide comment on any filing, maintenance or prosecution documentation with respect to [***] and will reasonably consider [***] comment on such filing, maintenance or prosecution documentation. If [***] determines to abandon, or not file a patent application included in, any of the [***], then at least [***] in advance of the relevant deadline: (a) [***] will notify [***] of its determination in writing; (b) [***] may, or may allow a Third Party to, file, prosecute, and maintain (in its sole discretion) such [***]; (c) upon [***] request, [***] will promptly provide all files related to filing, prosecuting, and maintaining such [***] to counsel designated by [***]; and (d) [***] will no longer be responsible for such costs and expenses relating to filing, prosecuting, and maintaining (as applicable) such [***].
10.3.2.[***] responsibility to File and Prosecute [***]. Following the Effective Date, [***] shall be solely responsible for, control of the filing, prosecuting (including in connection with any reexaminations, oppositions, and the like), and maintaining the [***]. [***] will be responsible for all costs and expenses in connection with such filing, prosecution, and maintenance. [***] will provide [***] a reasonable opportunity to review and provide comment on any filing, maintenance or prosecution documentation with respect to a [***], and will reasonably consider [***] comment on such filing, maintenance or prosecution documentation.
10.3.3.Servier Foreground IP. For the avoidance of doubt, [***].
10.3.4.Coordination and Cooperation. The non-prosecuting Party with respect to a particular Patent Right will cooperate with the prosecuting Party in connection with the filing, prosecution and maintenance of any [***], including by providing timely access to relevant persons, prior art, and executing all documentation reasonably requested by the prosecuting Party.
10.3.5.Patent Term Extensions. The Parties shall cooperate, if necessary and appropriate, with each other in gaining patent term extensions, including supplementary protection certificates and any other extensions that are now or become available in the future wherever applicable to [***]. [***] shall be solely responsible (without the requirement of obtaining [***] consent) for making the filings in respect of the [***]. [***] shall be responsible for making the filings in respect of the [***] and shall consider [***] interests and comments with respect thereto in good faith.
10.3.6.Defense of Patent Rights. As between the Parties, the Party controlling the preparation, filing, prosecution, and maintenance of the [***] as the case may be under this Section 10.3 (Filing, Prosecution and Maintenance of Patent Rights) will have the first right to defend against a declaratory judgment action, inter partes review, opposition proceeding, interference, or other action challenging any such patent, other than with respect to
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(a) any counter claims or defenses in any Infringement Action brought by the other Party pursuant to Section 10.4.2 (Infringement Actions), or (b) any action by a Third Party in response to an Infringement Action brought by the other Party, which, in both cases ((a) and (b)), will be controlled by such other Party.
10.3.7.Unified Patent Court. As regards European Patents pertaining to the Exclusive Licensed Patent Rights, the Parties herein agree to choose the European option and not the Unitary option [***] after the grant of the patent, and to exercise the option to Opt-out of the UPC (Unified Patent Court) in favor of national courts and [***] shall promptly provide [***] all documents necessary to implement this Section 10.3.7 (Unified Patent Court).
10.4.Patent Enforcement.
10.4.1.Third Party Infringement. During the Term, the Parties will promptly inform each other in writing if either Party becomes aware of any suspected, threatened, or actual infringement by any Third Party of any [***] (an “Infringement”), and in any case no later than [***] after becoming aware of such Infringement. In addition, each Party will promptly notify the other in the event such Party becomes aware of any action by a Third Party for a declaration that any of the [***] are infringed or are invalid, or unenforceable. In all cases, each Party will provide any available evidence of such Infringement or other conduct with such notification.
10.4.2.Infringement Actions.
(a)Exclusive Licensed Patent Rights.
(i)During the Term, [***] will have the first right (but not the obligation), to initiate and control an infringement, misappropriation, or other appropriate suit (an “Infringement Action”) with respect to any [***], at [***] sole discretion and at [***] sole cost and expense and using counsel of its own choice. Prior to commencing involvement in any such Infringement Action, [***] will consult with [***] and will consider [***] recommendations regarding the proposed Infringement Action.
(ii)If [***] desires to initiate such Infringement Action but may not do so due to Applicable Law or regulation (even as the assignee or exclusive licensee of such infringed Patent Right), then [***] may request that [***] be named as a party in such action or itself initiate such Infringement Action, at [***] cost and expense. [***] will take the lead in the control and conduct of any such Infringement Action under this Section 10.4.2(a) (Exclusive Licensed Patent Rights) and will keep [***] reasonably informed of any such Infringement Action, and [***] will reasonably assist [***] in any such Infringement Action under this Section 10.4.2(a) (Exclusive Licensed Patent Rights) at [***] expense.
(iii)If [***] fails to initiate an Infringement Action upon the earlier of: (A) expiration of the [***] period following first receipt by either Party of notice from the other Party of such Infringement under Section 10.4.1 (Third Party Infringement); or (B) [***] prior to the deadline for initiating such Infringement Action, then [***] will have the right (but not the obligation) to initiate and control an Infringement Action by counsel of its choice, at its own discretion and [***] sole cost and expense. [***] will have the right, at its own expense, to be represented in any such Infringement Action by counsel of its own choice. [***] will consult with [***] and will consider [***] recommendations regarding the proposed Infringement Action.
(iv)In no event may the Party controlling an Infringement Action under this Section 10.4.2(a) (Exclusive Licensed Patent Rights) settle any such
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Infringement Action in a manner that would limit the rights of the other Party or impose any obligation (monetary or otherwise) on the other Party, in each case, without the other Party’s prior written consent, which consent will not be unreasonably withheld, delayed, or conditioned.
(v)Recoveries. Any amount recovered in any Infringement Action under this Section 10.4.2(a) (Exclusive Licensed Patent Rights), including any amount recovered in any settlement of such Infringement Action, will first be used to reimburse each Party’s costs and expenses with respect to such Infringement Action (which reimbursement will be on a pro rata basis to the extent such costs and expenses exceed such recovered amount). Any remaining recoveries will be shared as follows: (i) if Servier is the enforcing Party, [***]; and (ii) if Black Diamond is the enforcing Party, [***].
(b)Licensed Combination Product Patent Rights. During the Term, [***] shall be solely responsible for initiating and controlling an Infringement Action with respect to [***]. Prior to commencing involvement in any such Infringement Action, [***] will consult with [***] and will consider [***] recommendations regarding the proposed Infringement Action.
10.5.Infringement of Third Party Rights.
10.5.1.Notice. If any Licensed Product becomes the subject of a Third Party’s claim or assertion of infringement of a Patent Right within the Territory, the Party first having notice of the claim or assertion will promptly notify the other Party.
10.5.2.Defense. Except as otherwise provided in Article 12 (Liability, Indemnification and Insurance), [***] shall be solely responsible for defending any such Third Party claim or assertion of infringement of a Third Party Patent Right with respect to [***], or pursue any invalidation proceedings against a Third Party Patent Right [***], at [***] expense. [***] will reasonably cooperate with [***], including if required to conduct such defense or invalidation proceedings, furnishing a power of attorney.
10.6.Settlement; Licenses. Except as otherwise provided in Article 12 (Liability, Indemnification and Insurance), neither Party will enter into any settlement of any claim described in Section 10.4 (Patent Enforcement) or Section 10.5 (Infringement of Third Party Rights) that affects the other Party’s rights or interests without such other Party’s written consent, such consent not to be unreasonably withheld, delayed, or conditioned. Each Party will have the right to decline to defend or to tender the defense of any claim described in this Section 10.5 (Infringement of Third Party Rights) upon reasonable written notice to the other Party, including if the other Party fails to agree to a settlement that the declining Party proposes.
11.TERM AND TERMINATION.
11.1.Term. This Agreement will be effective as of the Effective Date, and will continue, unless terminated earlier in accordance with this Article 11 (Term and Termination), until expiration of the last Royalty Term for the Licensed Product in the Territory on a country-by-country basis (the “Term”).
11.2.Termination for Convenience. [***] may terminate this Agreement in its entirety, or on a region-by-region basis with respect to [***], in each case, without cause upon providing [***] prior written notice to Black Diamond with such termination being effective upon the end of such [***] notice period.
11.3.Termination for Cause.
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11.3.1.Termination for Material Breach.
(a)If either Party believes in good faith that the other is in material breach of this Agreement, then the non-breaching Party (the “Non-Defaulting Party”) may deliver written notice of such breach to the other Party (the “Defaulting Party”). For any such alleged material breach, the allegedly breaching Party will, subject to Section 11.3.1(b) (Termination for Material Breach), have [***] (or, in the case of a payment breach, [***]) from the receipt of the initial notice to cure such breach. If the Party receiving notice of material breach fails to cure the breach within such [***] or [***] period, then the Non-Defaulting Party may terminate this Agreement in its entirety, or with respect to the country to which the breach relates as applicable, effective on written notice of termination to the Defaulting Party.
(b)In case the Defaulting Party disputes the existence or materiality of a material breach alleged by the Non-Defaulting Party within [***] under Section 11.3.1(a) (Termination for Material Breach), then the issue of whether the Non-Defaulting Party may properly terminate this Agreement on expiration of the applicable cure period will be resolved in accordance with Section 13.1 (Governing Law, Jurisdiction; Dispute Resolution) and the cure periods set forth in Section 11.3.1(a) (Termination for Material Breach) will be tolled for the duration of the dispute resolution proceedings until a final disposition is made. If, as a result of such dispute resolution proceeding, it is determined that the Defaulting Party committed a material breach, the Defaulting Party will have after the final disposition the remainder of the cure period plus [***] to cure the material breach. If the Parties dispute whether such material breach was so cured, such dispute will also be determined in accordance with Section 13.1 (Governing Law, Jurisdiction; Dispute Resolution). This Agreement will remain in full force and effect while any such dispute resolution proceeding is pending, such proceeding will not suspend any obligations of either Party hereunder and each Party will use reasonable efforts to mitigate any damage. If, as a result of such dispute resolution proceeding, it is determined that (i) the Defaulting Party did not commit such breach, (ii) such breach was not material or (iii) such breach was cured in accordance with this Section 11.3.1 (Termination for Material Breach), then no termination will be effective, and this Agreement will continue in full force and effect.
11.3.2.Termination for Bankruptcy. To the extent permissible under Applicable Laws, each Party will have the right to terminate this Agreement upon delivery of written notice to the other Party in the event that (a) such other Party files in any court or agency pursuant to any statute or regulation of any jurisdiction a petition in bankruptcy or insolvency or for reorganization or similar arrangement for the benefit of creditors or for the appointment of a receiver or trustee of such other Party or its assets, (b) such other Party is served with an involuntary petition against it in any insolvency proceeding and such involuntary petition has not been stayed or dismissed within [***] of its filing, or (c) such other Party makes an assignment of substantially all of its assets for the benefit of its creditors (each of (a) through (c), an “Insolvency Event”).
11.4.Termination for Safety Reasons. [***] shall be permitted to terminate the Agreement upon [***] prior notice for Safety Reasons.
11.5.Effects of Termination.
11.5.1.Termination of Licenses. Subject to Section 11.7 (Survival) and Section 7.3.4 (Fully paid-up, Royalty Free License), except as expressly set forth in this Agreement, this Agreement and all rights and licenses granted from one Party to the other under this Agreement will immediately terminate, provided however that all rights and licenses
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granted from Black Diamond to Servier will continue following termination solely [***], except that, in case of [***] material breach of [***] pursuant to Section 11.3.1 (Termination for Material Breach), [***] may, at its option, purchase from [***] all remaining inventory.
11.5.2.Reversion Rights. Following a termination of this Agreement for any reason other than [***] request within [***] from the applicable notice of termination, the following shall occur:
(a)Assignment of Regulatory Materials. With respect to the Licensed Compounds and Licensed Products in each Terminated Country, [***] to, assign to [***] all of its rights, title, and interests in and to all Development Data, Regulatory Materials and Regulatory Approvals related to such Licensed Compounds and Licensed Products owned or Controlled by [***] or any of its Affiliates or its Sublicensees (except in case of a Direct License) as of the effective date of termination, and (b) take those steps reasonably necessary to transfer ownership of all such assigned Regulatory Materials and Regulatory Approvals to [***], including submitting to each applicable Regulatory Authority a letter or other necessary documentation notifying such Regulatory Authority of the transfer of such ownership of such Regulatory Materials and Regulatory Approvals. [***] will be responsible for the costs of such assignment, except in the case of a termination due to Servier’s material breach under Section 11.3 (Termination for Cause), in which case [***] shall bear such costs.
(b)
(c)Ongoing Clinical Trials.
(i)Transfer to [***]. If, as of the effective date of termination of this Agreement with respect to the Licensed Products in each Terminated Country, [***] or its Affiliates or its Sublicensees (except in case of a Direct License) are conducting any Clinical Trials involving any Licensed Products, then, unless prohibited by any Regulatory Authority or Applicable Law, [***] written request on a Clinical Trial-by-Clinical Trial basis, [***] will transfer control of all such requested Clinical Trials to [***] or its designees. If [***] so elects, then [***] will continue to conduct such Clinical Trials to minimize interruption of any such Clinical Trials (including the assignment of all related investigator and other agreements relating to such Clinical Trials). [***] will reimburse [***] for the actual and documented out-of-pocket expenses incurred by Servier with respect to any transfer of Clinical Trials in compliance with this Section 11.5.2(b)(i) (Transfer to [***]), unless the Agreement has been terminated by [***] material breach under Section 11.3 (Termination for Cause), in which case [***] shall bear such costs.
(ii)[***] Wind-Down. If [***] does not elect to assume control of any such Clinical Trials, then [***] will, in accordance with accepted pharmaceutical industry norms and ethical practices, wind-down any on-going Clinical Trials of Licensed Products for which it has responsibility in such Terminated Country in an orderly manner.
(iii)Reversion License. Servier will grant to Black Diamond an exclusive, sublicensable (through multiple tiers), royalty-bearing license under the Servier Foreground IP in the Terminated Country(ies) solely to Develop, Manufacture, Commercialize or otherwise exploit the Licensed Compound and Licensed Products in the form such Licensed Compound and Licensed Products exist as of the effective date of termination. The Parties [***] for up to [***] and agree [***] as it exists as of the date of termination of this Agreement. If the Parties cannot agree upon such financial terms within such [***] period, then either Party may submit such dispute for resolution pursuant to 13.1.2 (Dispute Resolution).
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(d)Further Assistance. With respect to the Licensed Compounds and Licensed Products in each Terminated Country, Servier will, and will cause its Affiliates and Sublicensees (except in case of a Direct License) to provide any other assistance or take any other actions, in each case reasonably requested by Black Diamond, as necessary to transfer to Black Diamond the exploitation of such Licensed Compounds and Licensed Products, and will execute all documents as may be reasonably requested by Black Diamond in order to give effect to this Section 11.5.2 (Reversion Rights), provided that [***].
(e)Following a termination by [***] for a material breach of [***] pursuant to Section 11.3.1 (Termination for Material Breach), upon the request of [***], the Parties will discuss in good faith a reversion of rights to [***], provided that [***] shall not be obliged to enter into an agreement with [***] for such reversion.
11.5.3.Modification in Lieu of Termination. If, at any time during the Term, [***] material breach, then [***], by written notice to [***], elect to continue this Agreement as modified by this Section 11.5.3 (Modification in Lieu of Termination), as its sole and exclusive economic remedy in lieu of such termination or any other economic remedy available [***], in which case, effective as of the date [***] delivers such notice of such election to [***]:
11.5.4.with respect to royalties payable by Servier to Black Diamond pursuant to Section 7.3.1 (Royalty Payments) with respect to any Net Sales thereafter, the Royalty Rate set forth in Section 7.3.1 (Royalty Payments) shall be reduced by [***] of the rate set forth therein (and, for clarity, [***] will apply to the foregoing reduced royalty rate, and the royalty floor set forth in Section 7.3.3(e) (Cumulative Royalty Reductions) will be calculated based on such reduced royalty rate as a baseline);
11.5.5.the amount of any milestone payments payable by Servier to Black Diamond pursuant to Section 7.2 (Milestones) for any milestone event achieved thereafter shall be reduced by [***] of the applicable amount set forth therein;
11.5.6.Servier’s diligence obligations under this Agreement shall terminate; and
11.5.7.all other provisions of this Agreement shall remain in full force and effect without change.
11.5.8.Return of Confidential Information. Upon the expiration or termination of this Agreement for any reason with respect to a Licensed Compound or Licensed Product in the Terminated Country(ies), the Receiving Party will return (or, as directed by the Disclosing Party, destroy) all Confidential Information of the Disclosing Party related to such Licensed Compound or Licensed Product, as applicable, to the Disclosing Party that is in the Receiving Party’s possession or control (other than any Confidential Information required to continue to exercise a Party’s rights that survive termination of this Agreement) and immediately cease, and cause its Recipients to cease, use of such Confidential Information, provided, however, copies may be retained and stored solely for the purpose of determining its obligations under this Agreement, subject to the non-disclosure and non-use obligation under Article 8 (Confidentiality). Any agreement relating to archiving of Confidential Information that is returned to the Disclosing Party shall be transferred to the Disclosing Party, which shall solely be responsible for the payment of any related costs. The Receiving Party will have the right to destroy, at the Disclosing Party’s cost, any Confidential Information that the Disclosing Party has not requested to be returned. In addition, the Receiving Party will not be required to
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return or destroy Confidential Information contained in any computer system back-up records made in the ordinary course of business; provided that such Confidential Information may not be accessed without the Disclosing Party’s prior written consent or as required by Applicable Law.
11.5.9.Rights Accruing Prior to Expiration or Termination. Except as expressly set forth hereunder, any expiration or termination of this Agreement will be without prejudice to the rights or obligations of either Party against the other accrued or accruing under this Agreement prior to expiration or termination, including any payment obligation that accrued prior to the effective date of such expiration or termination.
11.5.10.Sublicences. Notwithstanding anything to the contrary herein, in case of termination of this Agreement for any reason, at [***].
11.6.Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by Black Diamond and Servier are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101 of the United States Bankruptcy Code. The Parties agree that each Party shall retain and may fully exercise all of its rights and elections under the United States Bankruptcy Code. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against a Party under the United States Bankruptcy Code, the other Party shall be entitled to a complete duplicate of (or complete access to, as appropriate) any intellectual property licensed to such other Party and all embodiments of such intellectual property, which, if not already in such other Party’s possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon such other Party’s written request therefor, unless the bankrupt Party elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under clause (a), following the rejection of this Agreement by the bankrupt Party upon written request therefor by the other Party.
11.7.Survival. The following provisions, as well as any other provisions that by their nature are intended to survive termination or expiration, will survive termination or expiration of this Agreement: Article 1 (Definitions); Section 7.2 (Milestones) through Section 7.4.8 (Interest) (solely with respect to any payment obligations that have accrued prior to the effective date of termination or expiration); Section 7.3.4 (Fully Paid-Up, Royalty Free License); Article 8 (Confidentiality) (for the duration set forth therein); Section 10.2 (Inventorship); Section 11.5 (Effects of Termination); Section 11.6 (Rights in Bankruptcy); this Section 11.7 (Survival); Section 12.1 (Indemnification by Black Diamond) through Section 12.3 (Procedure); Section 12.4 (Insurance) (for the duration set forth therein); Section 12.5 (Liability Limitations); and Article 13 (Miscellaneous).
12.LIABILITY, INDEMNIFICATION AND INSURANCE.
12.1.Indemnification by Black Diamond. Black Diamond shall indemnify, defend and hold harmless Servier, its Affiliates, and each of its and their respective employees, officers, directors, and agents (each, a “Servier Indemnified Party”) from and against any and all losses, damages, liabilities, settlements, penalties, fines and expenses (including reasonable attorneys’ fees and expenses) (collectively, “Liability”) that a Servier Indemnified Party is required to pay to one (1) or more Third Parties to the extent resulting from or arising out of:
(a)any breach by Black Diamond of any of its representations, warranties or covenants set forth in Article 9 (Representations and Warranties);
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(b)the gross negligence or willful misconduct by or of Black Diamond, its Affiliates and their respective officers, directors, agents and sublicensee;
(c)Black Diamond’s or its Affiliates activities under the Transition Plan, except with respect to any activity undertaken at the express direction of (and in compliance with the instructions of) Servier;
(d)Black Diamond’s, its Affiliates’ or licensees or subcontractors Development of the Licensed Compound or Licensed Product prior to the Effective Date;
(e)an Assigned Contract to the extent resulting during the period prior to the assignment of such contract under the Transition Plan; or
(f)any claims arising from or related to the Commercialization of the Licensed Compound and Licensed Products by Black Diamond in a Terminated Country, to the extent arising from activities conducted following the effective date of termination.
except in each case, to the extent caused by the gross negligence or willful misconduct of Servier or any Servier Indemnified Party, by breach of this Agreement by Servier, or resulting from an action for which Servier has an indemnification obligation pursuant to Section 12.2 (Indemnification by Servier).
12.2.Indemnification by Servier. Servier shall indemnify, defend and hold harmless Black Diamond, its Affiliates, and each of its and their respective employees, officers, directors, and agents (each, a “Black Diamond Indemnified Party”) from and against any and all Liabilities that a Black Diamond Indemnified Party is required to pay to one (1) or more Third Parties to the extent resulting from or arising out of:
(a)any breach by Servier of any of its representations, warranties or covenants set forth in Article 9 (Representations and Warranties);
(b)the gross negligence or willful misconduct by or of Servier, its Affiliates and their respective officers, directors, agents and Sublicensees; or
(c)any claims arising from or related to the Development, Manufacture, Commercialization or other exploitation of the Licensed Compound or Licensed Products by or on behalf of Servier, its Affiliates or Sublicensees;
except in each case, to the extent caused by the gross negligence or willful misconduct of Black Diamond or any Black Diamond Indemnified Party, or by breach of this Agreement by Black Diamond or any Black Diamond Indemnified Party or resulting from an action for which Black Diamond has an indemnification obligation pursuant to Section 12.1 (Indemnification by Black Diamond).
12.3.Procedure. Each Party will notify the other Party in writing if it becomes aware of a claim for which indemnification may be sought hereunder or under the Ancillary Agreements. In case any proceeding (including any governmental investigation) will be instituted involving any Party in respect of which indemnity may be sought pursuant to this Article 12 (Liability, Indemnification and Insurance), such Party (the “Indemnified Party”) will give prompt written notice of the indemnity claim to the other Party (the “Indemnifying Party”)
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and provide the Indemnifying Party with a copy of any complaint, summons or other written or verbal notice that the Indemnified Party receives in connection with any such claim. An Indemnified Party’s failure to deliver notice will relieve the Indemnifying Party of liability to the Indemnified Party under this Article 12 (Liability, Indemnification and Insurance) only to the extent such delay is prejudicial to the Indemnifying Party’s ability to defend such claim. Provided that the Indemnifying Party is not contesting the indemnity obligation, the Indemnified Party will permit the Indemnifying Party to control any litigation relating to such claim and the disposition of such claim by negotiated settlement or otherwise and any failure to contest prior to assuming control will be deemed to be an admission of the obligation to indemnify. The Indemnifying Party will act reasonably and in good faith with respect to all matters relating to such claim and will not settle or otherwise resolve such claim without the Indemnified Party’s prior written consent which will not be withheld, delayed or conditioned unreasonably; provided, that such consent will not be required with respect to any settlement involving only the payment of monetary awards for which the Indemnifying Party will be fully responsible. The Indemnified Party will cooperate with the Indemnifying Party in the Indemnifying Party’s defense of any claim for which indemnity is sought under this Agreement, at the Indemnifying Party’s cost and expense. [***].
12.4.Insurance.
12.4.1.Servier shall, at its own expense, obtain and maintain insurance with a reputable insurance carrier with respect to the Development, Manufacture and Commercialization of Licensed Compound and Licensed Products in the Field in the Territory under this Agreement in such type and amount and subject to such deductibles and other limitations as biopharmaceutical companies in the Territory customarily maintain with respect to the Development, Manufacture and Commercialization of similar compounds and products, but in any event no less than [***]. Such insurance policy shall provide product liability coverage and broad form contractual liability coverage for Servier’s indemnification obligations under this Agreement. Servier shall maintain such insurance policy for a period starting on the Effective Date and ending [***] following the date of termination or expiration of this Agreement. Servier shall provide a copy of such insurance policy to Black Diamond upon reasonable request by Black Diamond. Servier shall provide Black Diamond with written notice at least [***] prior to any cancellation, non-renewal or material change in such insurance.
12.4.2.Black Diamond shall, at its own expense, obtain and maintain insurance with a reputable insurance carrier with respect to the activities under the Transition Plan during the Transition Period and with respect to activities conducted prior to the Effective Date in such type and amount and subject to such deductibles and other limitations as biopharmaceutical companies in the Territory customarily maintain with respect to similar compounds and products, but in any event no less than [***]. Such insurance policy shall provide product liability coverage and broad form contractual liability coverage for Black Diamond’s indemnification obligations under this Agreement. Black Diamond shall maintain such insurance policy or an extended reporting period for such insurance coverage (i.e., a “tail”) for a period starting on the Effective Date and ending [***] after completion of the Transition Plan. Black Diamond shall provide Servier with an insurance certificate upon reasonable request by Servier. Black Diamond shall provide Servier with written notice at least [***] prior to any cancellation, non-renewal or material change in such insurance.
12.4.3.Servier’s obligations under this Section 12.4 (Insurance) shall survive expiration or termination of this Agreement and last until [***]s after the last sale of any Licensed Product in the Field in the Territory by Servier.
12.5.Liability Limitations.
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12.5.1.No Consequential Damages. EXCEPT WITH RESPECT TO ANY BREACH OF SECTION 2.4 (EXCLUSIVITY), ARTICLE 8 (CONFIDENTIALITY) OR ANY BREACH OF REPRESENTATIONS AND WARRANTIES UNDER ARTICLE 9 (REPRESENTATIONS AND WARRANTIES), IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES UNDER THIS AGREEMENT, EXCEPT TO THE EXTENT THE DAMAGES RESULT FROM A PARTY’S GROSS NEGLIGENCE, WILLFUL MISCONDUCT OR ARE PAYABLE IN CONNECTION WITH A PARTY’S INDEMNIFICATION OBLIGATIONS UNDER THIS ARTICLE 12 (LIABILITY, INDEMNIFICATION AND INSURANCE) FOR LIABILITY OWED TO THIRD PARTIES.
13.MISCELLANEOUS.
13.1.Governing Law, Arbitration; Dispute Resolution.
13.1.1.Governing Law. This Agreement, and all claims arising under or in connection therewith, will be governed by and interpreted in accordance with the substantive laws of the State of Delaware, United States, without regard to conflict of law principles thereof.
13.1.2.Dispute Resolution.
(a)In the event of a dispute arising out of or relating to this Agreement, either Party shall provide written notice of the dispute to the other, in which event the dispute shall first be referred [***] for attempted resolution. If the [***] do not resolve such dispute within [***] after such dispute was first referred to them, then such dispute shall be referred the [***] or their successors or designees, for attempted resolution by good faith negotiations within [***] after such notice is received.
(b)In the event the designated [***] do not resolve such dispute within the allotted [***], then except with respect to any matter that requires the mutual agreement of the Parties or for which [***] has final decision-making authority under Section 5.3 (Decision-Making), the Parties shall first refer the dispute to proceedings under the ICC Mediation Rules. Such mediation shall take place in [***] and shall be attended on behalf of each Party for at least one (1) session by a senior business person with authority to resolve the dispute.
(c)Any dispute not resolved under the procedures in Section 13.1.2 (Dispute Resolution) within [***] following the filing of a request for mediation or within such other period as the parties may agree in writing, shall be submitted to arbitration for final resolution by arbitration request (the “Arbitration Request”) under the Rules of Arbitration of the International Chamber of Commerce (the “Rules”) by [***] arbitrators appointed in accordance with the said Rules (each such arbitration, an “Arbitration”). Each Arbitration will be conducted in English and all foreign language documents shall be submitted in the original language and, if so requested by any arbitrator or Party, shall also be accompanied by a translation into English. The place of arbitration shall be [***]. The arbitrators in any Arbitration shall enforce and not modify the terms of this Agreement. The award of the arbitrators [***]. All [***] of any Arbitration, including reasonable attorneys’ fees and expenses and the administrative and arbitrator fees and expenses shall be borne by [***] as determined by the arbitrators. There shall be [***]. The parties agree that the “relevant to the case and material to its outcome” standard for document requests as set forth in Article 3 of the IBA Rules on the
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Taking of Evidence in International Arbitration (2020) shall guide the arbitral tribunal in deciding any issues related to document requests.
(d)Notwithstanding the preceding, the Parties acknowledge that the failure of the Parties to reach consensus as to any matter, which failure does not involve a breach by a Party of its obligations hereunder, shall not be deemed a dispute which may be referred for resolution by the Parties under this Section 13.1 (Governing Law, Arbitration; Dispute Resolution).
13.2.Force Majeure. No liability shall result from, and no right to terminate shall arise, in whole or in part, based upon any delay in performance or non-performance, in whole or in part, by either of the Parties to this Agreement to the extent that such delay or non-performance is caused by an event of Force Majeure. “Force Majeure” means an event that is beyond a non-performing Party’s reasonable control and which the Party could not reasonably anticipate, including an act of God, act of the other Party, strike, lock-out or other industrial/labor dispute not involving the non-performing Party’s own employees, war, riot, civil commotion, terrorist act, malicious damage, epidemic, quarantine, fire, flood, storm, natural disaster or compliance with any law or governmental order, rule, regulation or direction, whether or not it is later held to be invalid or inapplicable. The Force Majeure Party shall within [***] of the occurrence of the Force Majeure event, give written notice to the other Party stating the nature of the Force Majeure event, its anticipated duration and any action being taken to avoid or minimize its effect. Any suspension of performance shall be of no greater scope and of no longer duration than is reasonably required and the Force Majeure Party shall use reasonable effort to remedy its inability to perform; provided, however, if the suspension of performance continues or is anticipated to continue for [***] after the date of the occurrence, the unaffected Party shall have the right but not the obligation to perform on behalf of the Force Majeure Party for a period of such Force Majeure and such additional period as may be reasonably required to assure a smooth and uninterrupted transition of such activities. Notwithstanding the foregoing, [***].
13.3.Additional Approvals. Servier and Black Diamond shall cooperate and use respectively all commercially reasonable efforts to make all other registrations, filings and applications, to give all notices and to obtain as soon as practicable all governmental or other consents, transfers, approvals, orders, qualifications authorizations, permits and waivers, if any, and to do all other things necessary or desirable for the consummation of the transactions as contemplated hereby. Neither Party shall be required, however, to divest or out-license products or assets or materially change its business if doing so is a condition of obtaining any governmental approvals of the transactions contemplated by this Agreement.
13.4.Waiver and Non-Exclusion of Remedies. A Party’s failure to enforce, at any time or for any period of time, any provision of this Agreement, or to exercise any right or remedy shall not constitute a waiver of that provision, right or remedy or prevent such Party from enforcing any or all provisions of this Agreement and exercising any rights or remedies. To be effective any waiver must be in writing. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by law or otherwise available except as expressly set forth herein.
13.5.Notices.
13.5.1.Notice Requirements. Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if (a) delivered by hand, (b) sent by facsimile transmission (with transmission confirmed), (c) by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in Section 13.5.2 (Address for
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Notice) or to such other address as the Party to whom notice is to be given may have provided to the other Party in accordance with this Section 13.5.1 (Notice Requirements), or (d) provided by electronic mail, which electronic mail will be followed by one of the methods specified in the foregoing (a) – (c). Such notice shall be deemed to have been given as of the date delivered by hand or transmitted by facsimile (with transmission confirmed), on the second business day (at the place of delivery) after deposit with an internationally recognized overnight delivery service, or upon receipt of electronic mail. This Section is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement.
13.5.2.Address for Notice.
If to Black Diamond:
Black Diamond Therapeutics, Inc.
Attn: Chief Executive Officer
One Main Street,
14th Floor, Cambridge, MA 02142
Email: [***]
With a copy to:
Black Diamond Therapeutics, Inc.
Attn: General Counsel
One Main Street, 14th Floor, Cambridge, MA 02142
Email: [***]
Ropes & Gray LLP
Attn: [***]
800 Boylston Street
Boston, MA 02199
Email: [***]
If to Servier:
Servier Pharmaceuticals LLC
Attn: Chief Executive Officer
200 Pier Four Boulevard
Boston, MA 02210 USA
Email: [***]
With a copy to:
Servier Monde
Attn: General Counsel/Directeur Juridique
50 rue Carnot
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92284 Suresnes Cedex
Email: [***]
13.6.Entire Agreement. This Agreement, along with the Quality Agreement and any other agreement contemplated hereunder, constitutes the entire agreement between the Parties with respect to the subject matter of the Agreement. This Agreement supersedes all prior agreements, including that certain [***], whether written or oral, with respect to the subject matter hereof. Each Party confirms that it is not relying on any representations, warranties or covenants of the other Party except as specifically set out in this Agreement. Nothing in this Agreement is intended to limit or exclude any liability for fraud. All Schedules referred to in this Agreement are intended to be and are hereby specifically incorporated into and made a part of this Agreement. In the event of any inconsistency between any such Schedules and this Agreement, the terms of this Agreement shall govern.
13.7.Precedence. In the event of any inconsistencies between the provisions of this Agreement and those of any Ancillary Agreements, the provisions of this Agreement shall prevail.
13.8.Amendment. Any amendment or modification of this Agreement must be in writing and signed by authorized representatives of both Parties.
13.9.Assignment. Neither Party may assign its rights or delegate its obligations under this Agreement, in whole or in part without the prior written consent of the other Party, except that (a) each Party shall have the right, without such consent, to assign this Agreement and the Ancillary Agreements to (i) any of its Affiliates, or (ii) a successor to all or substantially all of the business to which this Agreement pertains, and (b) Black Diamond shall have the right, without such consent, to assign its right to receive payments (excluding, for the avoidance of doubt, any other rights, such as the right to receive payment reports) under this Agreement (which assignment may not, for the avoidance of doubt, authorize the assignee to enforce this contract against Servier without Servier’s prior written consent) to one or more Third Parties. Any permitted successor or assignee of rights or obligations hereunder or under the Ancillary Agreements shall, in a writing to the other Party, expressly assume performance of such rights or obligations. Each Party shall remain responsible for any failure to perform on the part of any such Affiliates. Any attempted assignment or delegation in violation of this Section shall be void. For the avoidance of doubt, neither Party will have the right to assign this Agreement, or any rights under this Agreement, to an entity that is listed on the European Union list of non-cooperative jurisdictions for tax purposes adopted by the European Council (as amended and updated from time to time), or an entity that is subject to Sanctions.
13.10.No Benefit to Others. Subject to Section 13.9 (Assignment), the provisions of this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and they shall not be construed as conferring any rights in any other persons except as otherwise expressly provided in this Agreement.
13.11.Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original and all of which taken together shall be deemed to constitute one and the same instrument. An executed signature page of this Agreement delivered by facsimile transmission shall be as effective as an original executed signature page. The Parties agree that execution of this Agreement by electronic signatures or by exchanging executed signature pages in .pdf format shall have the same legal force and effect as the exchange of original signatures.
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13.12.Severability. To the fullest extent permitted by Applicable Law, the Parties waive any provision of law that would render any provision in this Agreement invalid, illegal or unenforceable in any respect. If any provision of this Agreement is held to be invalid, illegal or unenforceable, in any respect, then such provision will be given no effect by the Parties and shall not form part of this Agreement. To the fullest extent permitted by Applicable Law and if the rights or obligations of any Party will not be materially and adversely affected, all other provisions of this Agreement shall remain in full force and effect and the Parties will use their best efforts to negotiate a provision in replacement of the provision held invalid, illegal or unenforceable that is consistent with Applicable Law and achieves, as nearly as possible, the original intention of the Parties.
13.13.Further Assurance. Each Party shall perform all further acts and things and execute and deliver such further documents as may be reasonably necessary or as the other Party may reasonably require to implement or give effect to this Agreement.
13.14.Relationship of the Parties. The status of a Party under this Agreement shall be that of an independent contractor. Nothing contained in this Agreement shall be construed as creating a partnership, joint venture, or agency relationship between the Parties or, except as otherwise expressly provided in this Agreement, as granting either Party the authority to bind or contract any obligation in the name of or on the account of the other Party or to make any statements, representations, warranties, or commitments on behalf of the other Party. All Persons employed by a Party or any of its Affiliates shall be employees of such Party or its Affiliates and not of the other Party or such other Party’s Affiliates and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party or its Affiliates, as applicable.
13.15.Construction. Except where the context requires otherwise, whenever used the singular includes the plural, the plural includes the singular, the use of any gender is applicable to all genders and the word “or” has the inclusive meaning represented by the phrase “and/or”. Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. The headings of this Agreement and any descriptions of Schedules or descriptions of cross references are for convenience of reference only and do not define, describe, extend or limit the scope or intent of this Agreement or the scope or intent of any provision contained in this Agreement. The terms “including,” “include(s),” “such as,” and “for example” as used in this Agreement mean including the generality of any description preceding such term and shall be deemed to be followed by “without limitation.”
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IN WITNESS WHEREOF, duly authorized representatives of the Parties have duly executed this Agreement to be effective as of the Effective Date.
| SERVIER PHARMACEUTICALS LLC | BLACK DIAMOND THERAPEUTICS, INC. |
|---|---|
| By_/s/ David Lee___________________ | By_/s/ Mark A. Velleca________________ |
| Name: David Lee | Name: Mark. A. Velleca |
| Title: Chief Executive Officer | Title: President and Chief Executive Officer |
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Schedule 1.14
Back-Up Compounds
[***]
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Schedule 1.74
Inventory
[***]
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Schedule 1.79
[***]
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Schedule 1.81
Licensed Patent Rights
[***]
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Schedule 1.135
Third Party Manufacturers
[***]
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Schedule 4.1
Transition Plan
[***]
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Schedule 8.4.2
Press release
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Press Release
Servier and Black Diamond Therapeutics Announce Global Licensing Agreement for BDTX-4933, A Targeted Oncology Therapy
▪The partnership underscores Servier’s commitment to developing targeted therapies that address unmet medical needs in oncology
▪Servier will develop and commercialize BDTX-4933, a Phase 1 asset with best-in-class potential targeting both RAS mutations and RAF alterations, in solid tumors, including non-small cell lung cancer
▪Black Diamond will receive an upfront payment of $70 million and up to $710 million in development and commercial sales milestone payments plus royalties
Suresnes (France), Cambridge, Mass. (USA), March [***], 2025 – Servier, an independent global pharmaceutical group governed by a non-profit foundation, and Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today announced a strategic worldwide licensing agreement for BDTX-4933, a potential best-in-class targeted therapy for solid tumors. Under this global agreement, Servier will develop and commercialize BDTX-4933, a small molecule designed by Black Diamond Therapeutics to address unmet medical needs in RAF/RAS-mutant solid tumors.
“At Servier, we are dedicated to transforming patient care in areas with significant unmet needs. Our partnership to develop BDTX-4933 is an important opportunity in targeted cancer therapies, as we believe we can serve more people by helping the right patients find the right treatment, at the right time,” said Claude Bertrand, Executive Vice-President of R&D at Servier. “We look forward to accelerating the development of this therapy as a potential best-in-class treatment for cancer patients.”
“This agreement supports our mission to advance oral cancer therapies designed to give patients the opportunity for longer, healthier, and more active lives,” said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. “Servier’s commitment to innovation and deep expertise in oncology make it an ideal partner for Black Diamond as we work to develop breakthrough cancer treatments.”
Under the terms of the agreement, Servier will lead the development activities and the worldwide commercialization of BDTX-4933 across multiple indications, including non-small cell lung cancer (NSCLC), with potential applications in other solid tumors. Black Diamond Therapeutics will receive an upfront payment of $70 million and will be eligible to receive up to $710 million in development and commercial sales milestone payments, along with tiered royalties based on global net sales.
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Press Release
Currently in Phase 1 development, BDTX-4933 is uniquely designed to target RAS and RAF alterations in solid tumors. The dose escalation and expansion cohort first-in-human study aims at evaluating safety and tolerability, the preliminary recommended Phase 2 dose, and antitumor activity of BDTX-4933 in adults with recurrent advanced/metastatic cancers harboring BRAF, CRAF, or NRAS mutations.
Servier Contact
For Media: presse@servier.com
Black Diamond Therapeutics Contacts
For Investors: investors@bdtx.com
For Media: media@bdtx.com
About Servier
Servier is a global pharmaceutical group governed by a non-profit Foundation that aspires to make a meaningful social impact for patients and for a sustainable world. The Group’s unique governance model preserves its independence while prioritizing long-term innovation for patients by reinvesting 100% of its profit in development of the company.
As a world leader in cardiometabolism and venous diseases, Servier brings transformative innovation in chronic diseases thanks to its holistic approach, making patient adherence a global priority. With the ambition of becoming a leading player in the field of rare cancers, Servier deeply invest in oncology and devotes close to 70% of its R&D budget to this field using precision medicine to create more effective treatments. Building on the Group’s success in oncology, Servier has decided to invest in neurology, a future growth driver for the Group. As such, Servier is focusing on a limited number of neurodegenerative diseases where accurate patient profiling makes it possible to offer a targeted therapeutic response through precision medicine. To promote widespread access to quality care at a lower cost, the Group also offers a range of quality generic drugs covering most pathologies, leveraging well-known brands in France, Eastern Europe, and Brazil. In all these areas, the Group takes patient considerations into account at every stage of the medicine life cycle.
Headquartered in France, Servier medicines are available in close to 140 countries. In 2023/2024, the Group which employs over 22,000 people worldwide, achieved sales revenue of €5.9 billion.
More information on: servier.com. Follow us on social media: LinkedIn, Facebook, Twitter, Instagram
About Black Diamond Therapeutics
Black Diamond Therapeutics is a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer. The Company’s MasterKey therapies are designed to address a broad spectrum of genetically defined tumors, overcome resistance, minimize wild-type mediated toxicities, and be brain penetrant to treat central nervous system disease. The Company is advancing a Phase 2 NSCLC trial of BDTX-1535, a brain-penetrant fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor targeting EGFR-mutant NSCLC and glioblastoma.
For more information, please visit www.blackdiamondtherapeutics.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the partnership with Servier and the intended and potential benefits thereof, including the receipt of potential milestone and royalty
ACTIVE/137201408.8


Press Release
payments from commercial product sales, along with tiered royalties based on global net sales, if any; Servier’s ability to develop and commercialize BDTX-4933, including the ongoing Phase 1 clinical trial of BDTX-4933; and the potential of BDTX-4933 to address the unmet medical need for patients with RAF/RAS-mutant solid tumors, including NSCLC. Any forward-looking statements in this press release are based on Black Diamond’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include those risks and uncertainties set forth in Black Diamond’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the United States Securities and Exchange Commission and in its subsequent filings filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Black Diamond undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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Document
Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO RULE 13a-14(a) OR 15d-14(a)
OF THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
I, Mark A. Velleca, certify that:
1.I have reviewed this Quarterly Report on Form 10-Q for the period ended March 31, 2025 of Black Diamond Therapeutics, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| Date: May 12, 2025 | By: | /s/ Mark A. Velleca |
|---|---|---|
| Mark A. Velleca<br><br>President, Chief Executive Officer<br><br>and Director<br><br>(Principal Executive Officer) |
Document
Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO RULE 13a-14(a) OR 15d-14(a)
OF THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
I, Erika Jones, certify that:
1.I have reviewed this Quarterly Report on Form 10-Q for the period ended March 31, 2025 of Black Diamond Therapeutics, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| Date: May 12, 2025 | By: | /s/ Erika Jones |
|---|---|---|
| Erika Jones<br><br>Senior Vice President, Finance<br><br>(Principal Financial Officer and Principal Accounting Officer) |
Document
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
Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, Mark A. Velleca, the Principal Executive Officer, and Erika Jones, the Principal Financial Officer, of Black Diamond Therapeutics, Inc. (the “Company”), hereby certify, that, to their knowledge:
(1)the Quarterly Report on Form 10-Q for the period ended March 31, 2025 (the “Report”) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| Date: May 12, 2025 | By: | /s/ Mark A. Velleca |
|---|---|---|
| Mark A. Velleca<br><br>President, Chief Executive Officer<br><br>and Director<br><br>(Principal Executive Officer) | ||
| Date: May 12, 2025 | By: | /s/ Erika Jones |
| --- | --- | --- |
| Erika Jones<br><br>Senior Vice President, Finance<br><br>(Principal Financial Officer and Principal Accounting Officer) |