# EDGAR Filing Document

**Accession Number:** 0001829802
**File Stem:** 0001193125-26-132014
**Filing Date:** 2026-3
**Character Count:** 1475483
**Document Hash:** e123cb89b2fe47499e6eecbfac6ba92d
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-26-132014.hdr.sgml**: 20260330

**ACCESSION NUMBER**: 0001193125-26-132014

**CONFORMED SUBMISSION TYPE**: 10-K

**PUBLIC DOCUMENT COUNT**: 112

**CONFORMED PERIOD OF REPORT**: 20251231

**FILED AS OF DATE**: 20260330

**DATE AS OF CHANGE**: 20260330

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Sensei Biotherapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001829802
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 10-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39980
- **FILM NUMBER:** 26813638

**BUSINESS ADDRESS:**
- **STREET 1:** 1405 RESEARCH BLVD, SUITE 125
- **CITY:** ROCKVILLE
- **STATE:** MD
- **ZIP:** 20850
- **BUSINESS PHONE:** (240) 243-8000

**MAIL ADDRESS:**
- **STREET 1:** 1405 RESEARCH BLVD, SUITE 125
- **CITY:** ROCKVILLE
- **STATE:** MD
- **ZIP:** 20850

?xml version='1.0' encoding='ASCII'? 10-K

**UNITED STATES** 

**SECURITIES AND EXCHANGE COMMISSION** 

**Washington, D.C. 20549** 

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**FORM** 10-K

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**(Mark One)** 

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

**For the fiscal year ended** December 31**,** 2025

**OR** 

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

**Commission File Number:** 001-39980

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Sensei Biotherapeutics, Inc.

**(Exact name of Registrant as specified in its Charter)** 

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| | |
|:---|:---|
| Delaware | 83-1863385 |
| **(State or other jurisdiction of**<br>**incorporation or organization)** | **(I.R.S. Employer**<br>**Identification No.)** |
| 1405 Research Boulevard**,** Suite 125<br>Rockville**,** MD | 20850 |
| **(Address of principal executive offices)** | **(Zip Code)** |

---

**Registrant's telephone number, including area code: (**240**)** 243-8000

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

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading Symbol(s)** | **Name of each exchange on which registered** |
| Common Stock, $0.0001 par value per share | SNSE | The Nasdaq Stock Market LLC |

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Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒

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, 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.

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| | | | |
|:---|:---|:---|:---|
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
| Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
|  |  | Emerging growth company | ☒ |

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

Indicate by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

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 June 30, 2025 (the last business day of the Registrant's second fiscal quarter), the Registrant's aggregate market value of its voting common equity held by non-affiliates was approximately $7.1 million based on the closing sale price of $8.58 per share as reported on the Nasdaq Capital Market on that date. The number of shares of Registrant's Common Stock outstanding as of March 23, 2026 was 1,340,281.

**DOCUMENTS INCORPORATED BY REFERENCE**

Portions of the Registrant's definitive proxy statement, to be filed pursuant to Regulation 14A under the Securities Exchange Act of 1934, for its 2026 Annual Meeting of Stockholders are incorporated by reference in Part III of this Form 10-K.

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**Table of Contents**

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| | | |
|:---|:---|:---|
|  |  | **Page** |
| **PART I** |  |  |
| &nbsp;&nbsp;Item 1. | [<u>Business</u>](#item_1_business) | 1 |
| &nbsp;&nbsp;Item 1A. | [<u>Risk Factors</u>](#item_1a_risk_factors) | 36 |
| &nbsp;&nbsp;Item 1B. | [<u>Unresolved Staff Comments</u>](#item_1b_unresolved_staff_comments) | 91 |
| &nbsp;&nbsp;Item 1C. | [<u>Cybersecurity</u>](#item_1c_cybersecurity) | 91 |
| &nbsp;&nbsp;Item 2. | [<u>Properties</u>](#item_2_properties) | 93 |
| &nbsp;&nbsp;Item 3. | [<u>Legal Proceedings</u>](#item_3_legal_proceedings) | 93 |
| &nbsp;&nbsp;Item 4. | [<u>Mine Safety Disclosures</u>](#item_4_mine_safety_disclosures) | 93 |
| **PART II** |  |  |
| &nbsp;&nbsp;Item 5. | [<u>Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities</u>](#item_5_market_for_registrants_common_equ) | 94 |
| &nbsp;&nbsp;Item 6. | [<u>Reserved</u>](#item_6_selected_financial_data) | 95 |
| &nbsp;&nbsp;Item 7. | [<u>Management's Discussion and Analysis of Financial Condition and Results of Operations</u>](#item_7_managements_discussion_analysis_f) | 96 |
| &nbsp;&nbsp;Item 7A. | [<u>Quantitative and Qualitative Disclosures About Market Risk</u>](#item_7a_quantitative_qualitative_disclos) | 105 |
| &nbsp;&nbsp;Item 8. | [<u>Financial Statements and Supplementary Data</u>](#item_8_financial_statements_supplementar) | 105 |
| &nbsp;&nbsp;Item 9. | [<u>Changes in and Disagreements With Accountants on Accounting and Financial Disclosure</u>](#item_9_changes_in_disagreements_with_acc) | 105 |
| &nbsp;&nbsp;Item 9A. | [<u>Controls and Procedures</u>](#item_9a_controls_procedures) | 105 |
| &nbsp;&nbsp;Item 9B. | [<u>Other Information</u>](#item_9b_or_information) | 106 |
| &nbsp;&nbsp;Item 9C. | [<u>Disclosure Regarding Foreign Jurisdictions that Prevent Inspections</u>](#item_9c) | 106 |
| **PART III** |  |  |
| &nbsp;&nbsp;Item 10. | [<u>Directors, Executive Officers and Corporate Governance</u>](#item_10_directors_executive_ficers_corpo) | 108 |
| &nbsp;&nbsp;Item 11. | [<u>Executive Compensation</u>](#item_11_executive_compensation) | 108 |
| &nbsp;&nbsp;Item 12. | [<u>Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters</u>](#item_12_security_ownership_certain_benef) | 108 |
| &nbsp;&nbsp;Item 13. | [<u>Certain Relationships and Related Transactions, and Director Independence</u>](#item_13_certain_relationships_related_tr) | 108 |
| &nbsp;&nbsp;Item 14. | [<u>Principal Accounting Fees and Services</u>](#item_14_principal_accounting_fees_servic) | 108 |
| **PART IV** |  |  |
| &nbsp;&nbsp;Item 15. | [<u>Exhibits, Financial Statement Schedules</u>](#item_15_exhibits_financial_statement_sch) | 109 |
| &nbsp;&nbsp;Item 16 | [<u>Form 10-K Summary</u>](#item_16_form_10k_summary) | 111 |

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**Cautionary Notice Regarding Forward-Looking Statements**

All statements other than statements of historical fact included in this Annual Report on Form 10-K, or the Report, including, without limitation, statements under "Business" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" regarding our financial position, business strategy and the plans and objectives of management for future operations, are forward-looking statements. When used in this Report, words and phrases such as "aim," "anticipate," "assume," "believe," "can," "continue," "could," "designed to," "estimate," "evaluate," "expect," "explore," "intend," "intended to," "likely," "may," "might," "objective," "ongoing," "plan," "potential," "predict," "project," "pursue," "seek," "should," "to be," "will," and "would," or the negative of such terms or other similar expressions, as they relate to us or our management, identify forward-looking statements.

Any statements in this Report, or incorporated herein, about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include statements regarding:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the ability of our preclinical studies and clinical trials to demonstrate acceptable safety and efficacy of our product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our beliefs regarding the scientific rationale for multi-node inhibition of the PI3K/AKT/mTOR pathway, including the potential for deeper and more durable pathway suppression compared to single-node inhibition, and the clinical utility of our approach across patient populations regardless of mutational status;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our beliefs regarding PIKTOR's efficacy and tolerability profile relative to other PI3K/AKT/mTOR pathway agents, which are based on cross-trial comparisons involving differences in trial design, patient populations, endpoints, and grading criteria;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•business disruptions affecting the initiation, patient enrollment, development and operation of our clinical trials;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the timing, progress and results of preclinical studies and clinical trials for our current and future product candidates, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and our research and development programs;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the timing, scope and likelihood of regulatory filings and approvals, including Investigational New Drug, or IND, submissions for our product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our ability to develop and advance our current product candidates and programs into, and successfully complete, clinical trials;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our ability to successfully integrate the operations of the Company and Faeth Therapeutics and to realize the anticipated benefits of the merger, including the advancement of the combined pipeline and retention of key personnel;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our manufacturing, commercialization, and marketing capabilities and strategy;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the need to hire additional personnel and our ability to attract and retain such personnel;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the size of the market opportunity for our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our expectations regarding the approval and use of our product candidates as first, second or subsequent lines of therapy or in combination with other drugs;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our expectations regarding the competitive landscape for PI3K/AKT/mTOR pathway therapies, including the anticipated clinical development, regulatory outcomes, and commercial positioning of competing product candidates, and our ability to compete effectively against such products, including other multi-node inhibitors and mutant-selective inhibitors;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the characteristics and therapeutic effects of our product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our ability to obtain and maintain regulatory approval of our product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our ability to recognize the benefits of our acquisition of Faeth Therapeutics;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our plans relating to the further development of our product candidates, including additional indications we may pursue;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering product candidates we may develop, including the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our reliance on third parties to manufacture and conduct clinical trials of our product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our ability to obtain, and negotiate favorable terms of, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the pricing and reimbursement of our product candidates we may develop, if approved;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the rate and degree of market acceptance and clinical utility of our current and future product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our financial performance and our ability to effectively manage our anticipated growth;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the impact of laws and regulations;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our expectations regarding the period during which we will qualify as an emerging growth company under the JOBS Act; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our anticipated use of our existing resources and the proceeds of any offerings of our securities.

These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to revise any forward-looking statements to reflect events or developments occurring after the date of this Report, even if new information becomes available in the future. You should refer to the Risk Factors section of this Report for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements.

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**PART I**

**Item 1. Business.**

*In this Annual Report, unless the context otherwise dictates, the terms (i) "we," "us," "our," "Sensei," the "Company" and other similar terms refer to the business and operations of Sensei Biotherapeutics, Inc. and its consolidated subsidiaries for periods prior to the Acquisition (as defined below) and to Sensei Biotherapeutics, Inc. and its consolidated subsidiaries, including Faeth Therapeutics for periods after the Acquisition; (ii) "Faeth HoldCo" refers to Faeth Holdings Therapeutics, Inc., (iii) "Faeth Subsidiary" refers to Faeth Therapeutics, LLC, a wholly owned subsidiary of Faeth HoldCo, (iv) "Faeth" or "Faeth Therapeutics" refer collectively to Faeth HoldCo and Faeth Subsidiary and (v) "Acquisition" refers to the acquisition by the Company of Faeth Therapeutics pursuant to that Agreement and Plan of Merger, dated February 17, 2026, by and among the Company, Sapphire First Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of the Company, Sapphire Second Merger Sub, LLC, a Delaware limited liability company and wholly owned subsidiary of the Company, Faeth HoldCo and Faeth Subsidiary.* 

**Overview**

We are a clinical-stage biotechnology company focused on improving outcomes for cancer patients through multi-node inhibition of critical oncogenic pathways. On February 17, 2026, we completed the acquisition of Faeth Therapeutics, a clinical-stage biotechnology company developing multi-node therapies that target tumor metabolism and signaling. The Acquisition brought Faeth's lead asset, PIKTOR, a proprietary investigational all-oral combination of serabelisib and sapanisertib that inhibits multiple nodes of the PI3K/AKT/mTOR pathway, into our pipeline. In connection with the Acquisition, we received $200 million in gross proceeds from a private placement financing, or the 2026 Private Placement, from a broad syndicate of investors, including several leading life sciences funds, including B Group Capital, Balyasny Asset Management, Columbia Threadneedle Investments, Cormorant Asset Management, Fairmount, Logos Capital, RA Capital Management, and Vivo Capital, to advance PIKTOR through key clinical milestones. For additional information regarding the terms of the Acquisition and the 2026 Private Placement, see Note 15 to the consolidated financial statements and "Management's Discussion and Analysis of Financial Condition and Results of Operations" included in this Annual Report.

Following the Acquisition, our lead program is PIKTOR, an investigational multi-node inhibitor, or MNI, of the PI3K/AKT/mTOR pathway in development for endometrial and breast cancer. The PI3K/AKT/mTOR pathway is dysregulated in up to 50% of all solid tumors, making it one of the most prevalent therapeutic targets in oncology. Despite this, currently approved therapies — all of which target only a single pathway node — have produced limited clinical benefits, often accompanied by toxicities that have constrained their utilization. Our core scientific thesis is that simultaneously suppressing multiple nodes of a pathway produces deeper, more durable tumor suppression than targeting any single-node alone, which we believe may also enable lower drug dosing, potentially contributing to an improved tolerability profile.

PIKTOR is currently being evaluated in an ongoing Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201), with topline data anticipated by year-end 2026, and we intend to initiate a Phase 1b trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101) by the first half of 2026.

Faeth was co-founded in 2019 by Anand Parikh and Oliver Maddocks, PhD, together with scientific founders Lewis Cantley, PhD, the discoverer of the PI3K pathway, Siddhartha Mukherjee, MD, DPhil, Karen Vousden, PhD, Scott Lowe, PhD, and Greg Hannon, PhD. We are led by an experienced management team with expertise spanning cancer biology, translational research, clinical drug development, regulatory affairs and corporate strategy gained through prior roles within both biotechnology and large pharmaceutical companies as well as academia.

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**Our Pipeline**

![img84782739_0.jpg](img84782739_0.jpg)

**Corporate Strategy**

Our mission is to improve the lives of patients by developing novel therapeutics to treat some of the most devastating types of cancer. Our strategy to achieve these goals centers on the following development priorities:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•We intend to establish PIKTOR's initial therapeutic proof of concept in endometrial cancer through our ongoing Phase 2 trial (FTH-PIK-201), with topline data anticipated by year-end 2026 and longer-term follow-up data in 2027.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Concurrently, we plan to broaden PIKTOR's development into advanced HR+/HER2- breast cancer through Study FTH-PIK-101, with trial initiation targeted for the first half of 2026, interim dose escalation data and expansion cohort initiation in 2027, and expansion cohort data in 2028.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Beyond these near-term priorities, we intend to explore PIKTOR's potential as a first-line treatment across our targeted indications. We believe that PIKTOR's convenient oral formulation, potentially differentiated therapeutic profile and demonstrated synergy in combination with many relevant agents in our targeted tumor types may benefit patients at the earliest stages of disease.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•We may also pursue development in additional indications, including ovarian cancer and genetically defined subtypes of lung cancer, as well as advance additional pipeline candidates beyond PIKTOR, including our NEAAR and IEM programs. In the future we intend to utilize our deep expertise in cancer and metabolic disease to identify additional compelling development opportunities.

**The PI3K/AKT/mTOR Pathway and the Case for Multi-Node Inhibition**

***Pathway Biology***

The PI3K/AKT/mTOR pathway is a vital, complex intracellular signaling network that plays a central role in regulating cellular metabolism, proliferation and survival by activating either pro-growth or regulatory signals in response to nutrient availability and extracellular stimuli. Given its importance to these key functions of healthy cells, it is not surprising that dysregulated pathway activity can play an integral role in tumorigenesis, proliferation and treatment resistance as many validated cancer targets, in their natural state, govern these processes. It is estimated that the growth of up to 50% of all solid tumors is driven or amplified by the aberrant activation of the PI3K/AKT/mTOR pathway, as depicted below.

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![img84782739_1.jpg](img84782739_1.jpg)

*Source: cBioPortal for Cancer Genomics (approximately 21,000 patients). Cerami et al., Cancer Discov. 2012; Gao et al., Sci. Signal, 2013. NSCLC: non-small cell lung cancer.*

The key components of the pathway are:

**Phosphoinositide 3-kinase (PI3K)**, an upstream node in the pathway which is activated by various growth factor receptors in response to extracellular stimuli to produce either growth or regulatory signals. PI3K is further broken down into four subtypes, or isoforms, that are expressed in different cell types. The PI3K alpha isoform (PI3Kα, encoded by the *PIK3CA* gene) is responsible for either initiating or regulating cellular proliferation.

**AKT serine/threonine kinase (AKT)**, a central coordinator that receives the signals from PI3K and ensures that the cell responds in the appropriate manner based on the nature of the signal.

**Mechanistic target of rapamycin (mTOR)**, which orchestrates cell growth, proliferation and survival by determining whether cells grow and divide or conserve their resources in response to signals from PI3K/AKT. mTOR operates through two distinct complexes: mTORC1 and mTORC2. mTORC1 is activated when nutrients are abundant, driving cell growth and proliferation. mTORC2 plays a role in controlling the full activation of AKT in either a proliferative or regulatory state.

**Phosphatase and tensin homolog (PTEN)**, a pathway regulator that counteracts PI3K's pro-growth actions to ensure the PI3K/AKT pathway's pro-growth activities are appropriately controlled in healthy tissues.

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![img84782739_2.jpg](img84782739_2.jpg)

***The PI3K/AKT/mTOR Pathway***

Mutation of the *PIK3CA* gene is the most common oncogenic alteration of the PI3K/AKT/mTOR pathway, encompassing approximately 40% of total pathway mutations. However, mutations in any pathway component, which collectively outnumber those to PI3Kα, can also lead to oncogenic activity and the pathway can also be aberrantly activated in support of tumor growth in its non-mutated, "wild type" state either by dysregulated upstream signaling or as an adaptive response to therapy. The pathway's ability to support tumors without its own mutation suggests its clinical relevance may extend beyond those patients with direct pathway mutations.

![img84782739_3.jpg](img84782739_3.jpg)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Broader pathway mutations outnumber PI3Kα** 

*Source: cBioPortal for Cancer Genomics (approximately 21,000 patients). Cerami et al., Cancer Discov. 2012; Gao et al., Sci. Signal, 2013. The "PIKTOR = 85%" figure represents the estimated percentage of PI3K/AKT/mTOR pathway-mutated tumors, across the tumor types depicted, that harbor mutations within the broad pathway nodes addressable by PIKTOR*'*s multi-node mechanism (PI3Kα, mTORC1, mTORC2 and associated pathway components). The "Mut Spec = 8%" figure represents the estimated average percentage of endometrial tumors harboring a PIK3CA mutation as the sole pathway alteration, reflecting the narrower population that may be addressable by mutant-specific PI3Ka inhibitors. The percentages in the Venn diagram relate to all ten tumor types reflected in the bar chart. These estimates are based on the Company's analysis of publicly available genomic data. NSCLC: non-small cell lung cancer.*

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***Approved Single-Node Inhibitors (SNI) Therapies and Their Limitations***

Given the relevance of the PI3K/AKT/mTOR pathway in the context of cancer, considerable effort and resources have been expended to develop pathway inhibitors. These efforts have resulted in the approval of five agents for the treatment of PI3K/AKT/mTOR pathway-associated solid tumors, each of which is a single-node inhibitor, or SNI, of the pathway:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Alpelisib: selective PI3Kα inhibitor

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Inavolisib: selective PI3Kα inhibitor

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Capivasertib: pan-AKT inhibitor

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Everolimus: mTORC1 inhibitor

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Temsirolimus: mTORC1 inhibitor

The currently approved therapies have focused on single-node inhibition and PI3Kα isoform selectivity in an attempt to improve the class's therapeutic window. Earlier pan-PI3K isoform inhibitors produced numerous trial failures, and one withdrawn approval, due to weak efficacy or immunologic and metabolic toxicities.

The primary factor limiting the effectiveness of these approved treatments is that inhibition of a single pathway node can produce only partial pathway suppression, leaving the remaining nodes available to sustain or reroute oncogenic signaling. This approach, common in cancer drug development and successful in other settings where tumor growth is driven by a single mutated "on/off switch," is inadequate in this setting due to the redundant, distributed signaling capabilities of the PI3K/AKT/mTOR pathway. SNIs, therefore, have only limited impact on many key oncogenic dysregulations and are circumvented by the acute adaptive rerouting of signaling, and due to emergence of additional pathway mutations, both of which arise in response to treatment. SNIs have also been associated with elevated on-target toxicities that have led to either clinical trial discontinuations or restricted commercial uptake.

***The MNI Thesis***

The discovery and development of targeted therapies for cancer in the early 2000s marked a major innovative breakthrough in cancer treatment and has improved the lives of millions of patients over the past two decades. More than twenty years of experience with these treatments, however, has taught us that cancer's biology is often far too complex to be vanquished by the blockade of single oncogenic mutations.

Our core scientific thesis is that simultaneously suppressing multiple nodes of complex signaling pathways can produce deeper, more durable tumor suppression than targeting any single node alone because it not only can block initial oncogenic mutations but also restrict the development of adaptive resistance mechanisms that emerge in response to treatment. Emerging clinical evidence suggests that SNI-driven suppression may itself promote acquired resistance, further underscoring the need for a more comprehensive approach.

In contrast to single-node inhibition, MNIs are designed to better match the biologic architecture of the PI3K/AKT/mTOR pathway to maintain durable suppression, as they not only inhibit initial dysregulated oncogenic signaling at multiple points but also shut down the "escape routes" that tumors often employ to resist treatment. Because MNI suppresses the pathway more comprehensively, emerging evidence suggests its clinical benefit may extend beyond patients with direct pathway mutations to include tumors where the pathway is aberrantly activated as a resistance mechanism rather than a primary oncogenic driver. This differentiated capability has been reflected in clinical trial data generated by some development stage MNIs relative to the approved SNIs, as discussed further below.

**PIKTOR — Our Lead Clinical Candidate**

***Composition and Mechanism of Action***

PIKTOR, our lead clinical candidate, is an oral MNI of the PI3K/AKT/mTOR pathway. PIKTOR is comprised of two independently dosed inhibitors of discrete pathway nodes:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Serabelisib**, a selective phosphoinositide 3-kinase alpha (PI3Kα) inhibitor

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Sapanisertib**, a mammalian target of rapamycin complexes (mTORC) 1 and 2 inhibitor

PIKTOR's design reflects a strategy of vertical pathway blockade, targeting PI3Kα upstream and mTORC1 and mTORC2 downstream, simultaneously addressing oncogenic pathway activation and the adaptive escape routes tumors employ to resist treatment,

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while suppressing downstream signaling regardless of mutational status. In addition, the selectivity of serabelisib for PI3Kα versus other PI3K isoforms may reduce the risk of off-target toxicities associated with pan-PI3K inhibition.

![img84782739_4.jpg](img84782739_4.jpg)

**PIKTOR's Multi-node Mechanism of Action**

*Source: Tyrakis et al., British Journal of Cancer, 2025; 133: 144–154. Hopkins BD, Pauli C, Du X, Wang DG, Li X, Wu D, et al. Suppression of insulin feedback enhances the efficacy of PI3K inhibitors. Nature. 2018;560:499–503.* 

***Differentiated Product Profile***

We believe PIKTOR may have a substantially differentiated clinical profile versus both currently available and developmental treatments for multiple solid tumors, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Oral MNI mechanism of action**, providing convenient administration relative to IV-based alternatives

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Favorable emerging tolerability profile**, with rates of hyperglycemia and stomatitis observed in clinical trials to date that compare favorably to those reported for both approved SNIs and other MNIs in development, as described in the "Emerging Safety Profile" section below

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Potentially best-in-class-potency,** with preclinical data suggesting PIKTOR may achieve pathway suppression at lower concentrations than either approved or developmental competitors

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Broad anti-tumor impact**, with responses observed across multiple tumor types and mutational profiles, including in patients with no detectable PI3K/AKT/mTOR pathway mutations, suggesting that multi-node inhibition may confer clinical benefit independent of mutational status

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Selective PI3Kα inhibition** that may avoid immunologic toxicity that has been historically associated with pan-PI3K inhibitors

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Synergistic activity** with CDK4/6 inhibitors, taxane-based chemotherapy, and potentially selective estrogen receptor degraders, or SERDs, as observed in preclinical models — all of which are important components of current treatment regimens across our targeted tumor types

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Tunability** that may potentially enable indication-specific dose optimization of each component through independent dosing of serabelisib and sapanisertib

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![img84782739_5.jpg](img84782739_5.jpg)

![img84782739_6.jpg](img84782739_6.jpg)

**PIKTOR achieves pathway suppression at lower concentrations than other PI3K/AKT/mTOR targeted agents** 

*Source: Tyrakis et al., British Journal of Cancer, 2025; 133: 144–154. IC50 values represent the concentration required to achieve 50% reduction in cell number versus control in each cell line. PIKTOR values reflect the sapanisertib IC50 for the combination of serabelisib and sapanisertib at fixed ratio representing clinical exposure. ¹ Tyrakis et al., British Journal of Cancer, 2025; 133: 144–154. ² The Company's internal data. Gedatolisib IC50 values in the endometrial cancer cell lines and data for the paclitaxel-resistant cell line variants are based on the Company's internal preclinical analyses and have not been independently published. ND = not done. Note: When comparing serabelisib and alpelisib, the clinically relevant human exposure for serabelisib is 3-4-fold higher than alpelisib. The IC50 values shown above are derived from in vitro preclinical studies conducted under varying experimental conditions, including differences in cell lines, assay protocols, drug concentrations and combination ratios. No head-to-head preclinical or clinical studies have been conducted among the agents shown. In vitro results may not be predictive of clinical outcomes, and these comparisons should be interpreted with caution.*

***PK/PD Profile and Phase 2 Dose for Study FTH-PIK-201***

Findings from prior development work have led to the characterization of PIKTOR's differentiated pharmacokinetic/pharmacodynamic, or PK/PD, profile and the identification of PIKTOR's phase 2 dose, or RP2D, of 3mg sapanisertib/200mg serabelisib administered on an intermittent dosing schedule of three days per week on a continuous monthly cycle that we are utilizing in our ongoing Phase 2 trial in endometrial cancer, study FTH-PIK-201. We believe this PK/PD-enabled dosage level and frequency combination is important to PIKTOR's potentially differentiated clinical profile because it is designed to maximize the amount of time that plasma concentrations of PIKTOR are at or above in vitro IC90 concentration — potentially as much as two to three times longer per month than competitors — while being within levels that have been generally well tolerated by patients in previous studies.

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![img84782739_7.jpg](img84782739_7.jpg)

**Oral PIKTOR dosing designed to enable sustained exposure and limit risk of potential Cmax-related toxicity**

*Plot shows ratio of human plasma drug concentration to in vitro (cellular) IC90 for sapanisertib (cellular IC90 determined in HR+ breast cancer cell lines for sapanisertib + serabelisib). Pharmacokinetic (PK) data is modeled from Faeth internal human PK studies and represents Sapanisertib oral capsule 3 mg given once a day with food for 3 days with serabelisib.*

***Emerging Safety Profile***

Beyond the potential efficacy advantages of PIKTOR, we believe clinical data to date suggest a tolerability profile that may compare favorably to both currently approved SNIs and other MNIs in development. The management of treatment-related adverse events, particularly hyperglycemia and stomatitis, has been a meaningful challenge with existing PI3K/AKT/mTOR pathway therapies and has in some cases limited their commercial uptake. Both toxicities have to date been observed at substantially lower rates in our ongoing Phase 2 clinical trial of PIKTOR in advanced endometrial cancer (Study FTH-PIK-201) relative to rates reported in published clinical trials of several other PI3K/AKT/mTOR pathway agents, as depicted below. These comparisons are derived from different clinical trials conducted at different points in time with differences in trial design, including different grading criteria. No head-to-head trials have been conducted among the agents shown, and cross-trial comparisons must be interpreted with caution.

![img84782739_8.jpg](img84782739_8.jpg)

**Hyperglycemia Adverse Event rates of selected PI3K pathway compounds**

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![img84782739_9.jpg](img84782739_9.jpg)

**Stomatitis Adverse Event Rates of selected PI3K pathway compounds**

*Source: Inavolisib: Jhaveri et al. JCO 2024;42(33):3947-3956 (n=20). RLY-2608: ASCO Poster 2025, 600 mg BID, RP2D Cohort (n=64). STX-478: Juric D. et al., ESMO Presentation 2025 (n=205). Gedatolisib (Ph3): Celcuity VIKTORIA-1 Phase 3 Results Presentation, Doublet Arm, Oct 2025 (n=130). PIKTOR Ph2 Endo: Data snapshot, FTH-PIK-201, PIKTOR + Paclitaxel in patients with advanced endometrial cancer, data as of January 5, 2026, ongoing Faeth-sponsored multicenter Phase 2 trial (n=22). Alpelisib: Andre, F. et al., N Engl J Med 2019;380:1929-40 (n=284). Gedatolisib (Ph1b): Layman et al., 2022, SABCS 2022 Poster (n=103).*

PIKTOR has several characteristics that we believe may contribute to this emerging tolerability profile. Its PI3Kα isoform specificity may reduce the potential risk of immune compromising toxicities that have been previously associated with pan-PI3K inhibitors. Its oral formulation and intermittent dosing schedule are designed to maintain plasma concentrations within a therapeutic range while avoiding the extreme peak concentrations that may be associated with certain adverse events. In addition, by achieving more complete pathway suppression across multiple nodes, PIKTOR can be administered at substantially lower doses of each component than are required for monotherapy, which we believe may confer deeper efficacy within a more tolerable clinical profile.

**Clinical Development History and Evidence to Date**

***Development History***

Both serabelisib and sapanisertib have been studied either alone or in combination, including in combination with other agents, in multiple preclinical studies and in clinical trials involving approximately 1,050 patients at a range of doses. Within the completed studies, 152 patients have received PIKTOR at doses ranging from 2mg to 8mg of sapanisertib and from 100mg to 400mg of serabelisib and in either daily or intermittent schedules in three clinical trials, one of which included both dose escalation and dose expansion cohorts. Across these studies, PIKTOR was generally well tolerated with most AEs considered possibly drug related being mild or moderate in severity. A total of 13 drug-related significant adverse events, or SAEs, all non-fatal, were reported across the three trials. SAEs reported by more than one participant were: increased transaminases (4), nausea (2), vomiting (2), and hyperglycemia (2).

The data that have emerged from these clinical trials — each component demonstrating anti-tumor activity as monotherapy, and the combination generally well tolerated at low doses with clinical activity alongside other agents — support our belief that PIKTOR has the potential to provide more comprehensive and tolerable PI3K/AKT/mTOR pathway inhibition than current SNIs, and may be differentiated from other MNIs in development.

***Phase 1b Study X31025 — Results***

Study X31025 was an investigator-initiated, Phase 1, open-label, single center, dose-escalation trial of PIKTOR in combination with weekly paclitaxel in 19 heavily pretreated patients (averaging four prior lines of therapy) with advanced breast (3), endometrial (6) and ovarian (10) tumors. All but one patient had been previously treated with taxane-based chemotherapy. The study consisted of five dose cohorts which were administered via a three days per week/four weeks per month intermittent dosing schedule. Doses ranged from 2mg to 4mg of sapanisertib, 100mg to 200mg of serabelisib and 60 mg/m² to 80 mg/m² of paclitaxel.

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***Efficacy Results***

At the conclusion of the study, 15 patients were evaluable for efficacy. The objective response rate (ORR) was 47% and the Clinical Benefit Rate, or CBR, was 73%. Amongst patients expressing at least one PI3K/AKT/mTOR pathway mutation, the ORR increased to 71%. Individual patient responses were:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•3 Complete Responses, or CRs, all in endometrial cancer patients who had failed previous taxane treatment

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•4 Partial Responses, or PRs, 1 breast, 2 ovarian, and 1 endometrial

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•4 Stable Disease, or SD, all ovarian, for greater than or equal to 6 months

At the time of the data cutoff for the publication, median Progression-Free Survival, or PFS, was 11 months, and overall survival, or OS, was 17 months. The genetic profiles of the tumors revealed that 2 patients had direct PI3Kα mutations, 5 had broader PI3K/AKT/mTOR pathway mutations, and 8 had no pathway mutations. Responses were observed across all tumor types and in all mutational classifications.

![img84782739_10.jpg](img84782739_10.jpg)

**Patient tumor types, mutations and response status from Phase 1b trial, X31025**

*Source: Starks DC, Rojas-Espaillat L, Meissner T, Williams CB. Phase I dose escalation study of dual PI3K/mTOR inhibition by Sapanisertib and Serabelisib in combination with paclitaxel in patients with advanced solid tumors. Gynecologic Oncology. 2022 Jul 15. n=19 enrolled (15 response evaluable, 13 RECIST evaluable). Data cutoff per publication October 1, 2021. All but one subject had prior platinum and taxane-based chemotherapy. Seven subjects (36%) had prior mTORC1 inhibitor therapy (temsirolimus/everolimus).*

*Abbreviations: LOT = Lines of Therapy; ORR = Objective Response Rate; CBR = Clinical Benefit Rate; PFS = Progression-Free Survival.*

***Tolerability Results***

PIKTOR was generally well tolerated in the trial. Most treatment emergent adverse events were classified as mild or moderate and only one dose-limiting toxicity (DLT), which occurred at dose level 5, was observed. The most frequent grade 3 or 4 adverse events were decreased white blood cells, nonfebrile neutropenia, hyperglycemia, anemia, and elevated liver enzymes.

***FTH-PIK-201 January 2026 Data Snapshot***

PIKTOR's tolerability profile was further informed by the results of a data snapshot we conducted in January 2026 of 22 advanced endometrial cancer patients enrolled in Study FTH-PIK-201. The data showed that PIKTOR continued to be generally well tolerated. Patients experienced stomatitis (13.6% any grade, 0% grade 3/4) and hyperglycemia (13.6% any grade and 4.5% grade 3/4) at levels that compare favorably to existing SNIs and development-stage MNIs. Of note, patients in the PIK-201 study are not required to use any steroid mouthwash prophylaxis.

**Clinical Development Plans by Indication**

PIKTOR's development is advancing in large, urgent areas of unmet need where dysregulated PI3K/AKT/mTOR pathway activity is strongly implicated in oncogenesis and tumor progression and patients often face a dire prognosis.

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***Advanced HR+/HER2- Breast Cancer***

***Disease Overview and Unmet Need***

Breast cancer is the most common cancer diagnosed among women in the United States, where it is projected there will be approximately 325,000 new diagnoses in 2026. The most common form of breast cancer is HR+/HER2-, a hormonally driven tumor subtype, which accounts for approximately 70% of overall breast cancer incidence. Amongst total HR+/HER2- cases, approximately 60% express PI3K/AKT/mTOR pathway mutations.

In 2026, an estimated 58,000 HR+/HER2- breast cancer patients are expected to be diagnosed with or progress to advanced disease stages in the United States. For these patients, the current standard of care first-line regimen is endocrine based therapy, either an aromatase inhibitor, or AI, or a SERD in combination with a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. Together, these agents can slow tumor growth by blocking dysregulated signaling from the hormone receptors on tumors (SERD, AI), as well as the downstream cellular division processes that translate these oncogenic signals into uncontrolled proliferation (CDK4/6). Despite the anti-tumor benefits of this regimen, however, most patients will still experience disease progression within three years from diagnosis, with an expected survival rate at five years of 34%.

***Approved SNIs in HR+/HER2- Advanced Disease***

Given the strong implication of the PI3K/AKT/mTOR pathway in tumor progression in this setting, the addition of a SNI is recommended for subsequent rounds of endocrine/CDK4/6 therapy following initial progression. There are currently four agents approved for PI3K/AKT/mTOR pathway-altered HR+/HER2- advanced breast cancer, spanning both first- and second-line settings:

**First-line (endocrine-resistant, PIK3CA-mutated)**: Inavolisib (selective PI3Kα inhibitor/degrader), approved in October 2024 in combination with palbociclib and fulvestrant, is the first targeted therapy approved specifically for the first-line treatment of endocrine-resistant, PIK3CA-mutated HR+/HER2- advanced breast cancer. In its pivotal Phase 3 trial, INAVO120, the inavolisib-based triplet more than doubled median PFS compared to palbociclib and fulvestrant alone (15.0 months vs. 7.3 months), reducing the risk of disease progression or death by 57% (HR 0.43). Updated overall survival data have demonstrated a statistically significant survival benefit as well.

**Second-line and beyond (post-CDK4/6 progression)**: Three additional agents are approved for use following progression on CDK4/6 inhibitor-based therapy: alpelisib (selective PI3Kα inhibitor), capivasertib (pan-AKT inhibitor), and everolimus (mTORC1 inhibitor). Of these, the best data generated to date was shown by capivasertib in combination with fulvestrant, a SERD. In its pivotal trial, CAPItello-291, the combination improved median PFS in the PIK3CA/AKT1/PTEN-altered subgroup to 7.3 months vs. 3.1 months for fulvestrant alone, reducing the risk of disease progression or death (hazard ratio) by 50%.

Notably, all four approved agents are single-node inhibitors, each targeting only one component of the PI3K/AKT/mTOR pathway. Three of the four (inavolisib, alpelisib, and capivasertib) also require the presence of specific activating mutations for their approved indications, limiting their addressable patient populations.

***MNI Class Validation via Gedatolisib***

Recent clinical trial results from the VIKTORIA-1 trial (PIK3CA-wild-type cohort) of the PI3K/AKT/mTOR pathway MNI gedatolisib (an IV pan PI3K/mTORC1/2 inhibitor) in combination with fulvestrant alone and fulvestrant and palbociclib in combination in advanced HR+/HER2- breast cancer patients with no PIK3CA mutation who are post endocrine therapy/CDK4/6 progression have offered compelling clinical validation for the thesis that an MNI approach can improve outcomes relative to SNIs.

Gedatolisib's results to date have compared favorably relative to the currently approved SNIs, including: PFS of 9.3 months for the gedatolisib triplet (gedatolisib plus fulvestrant plus palbociclib) (HR 0.24) and 7.4 months for the gedatolisib doublet (gedatolisib plus fulvestrant) (HR 0.33) versus fulvestrant alone. Both of these results are superior to any data generated to date in comparable patients by an SNI. We believe these results further validate the superiority of MNI to SNI.

***PIKTOR's Development Rationale***

Beyond gedatolisib's MNI class-validating results, we believe PIKTOR's substantial body of preclinical evidence demonstrating deep pathway suppression and activity in multiple breast tumor models, including in synergistic combination with palbociclib, provides evidence that PIKTOR has the potential to produce a meaningful benefit to patients in this setting.

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![img84782739_11.jpg](img84782739_11.jpg)

**PIKTOR's impact on the MDA-MB-361 breast cancer model**

*Source: Tyrakis et al., British Journal of Cancer, 2025; 133: 144–154 / Faeth Internal Data. Serabelisib dosed at 75 mg/kg (mouse equivalent of 200mg in humans), PO QD, 3 days on / 4 days off. Sapanisertib dosed at 0.5 mg/kg (mouse equivalent of 3mg in humans), PO QD, 3 days on / 4 days off. MDA-MB-361 cell line mutations: PIK3CA, MTOR, BRCA2, BRAF, CDKN2A, TP53. The human-equivalent doses correspond to the RP2D of 200mg serabelisib / 3mg sapanisertib utilized in the Company's ongoing clinical trials.*

In addition, results from a Phase 2 clinical trial (Garcia-Saenz et al., 2022) showing that sapanisertib, administered daily and at higher doses than we are contemplating in our future clinical development plans due to tolerability risks, in combination with fulvestrant, could produce comparable results to gedatolisib plus fulvestrant (21.3% Objective Response Rate, or ORR, PFS 7.2 months for sapanisertib plus fulvestrant vs. 28.3% ORR and 7.4 months PFS for gedatolisib plus fulvestrant) in advanced HR+/HER2- breast cancer patients. These are cross-trial comparisons involving different patient populations and trial designs, and should be interpreted with caution.

***PIKTOR's Potential for Differentiation Amongst MNIs in HR+/HER2- Breast Cancer***

In addition to the general safety and PK/PD profile advantages described in the "Emerging Safety Profile" and "Differentiated Product Profile" sections above, we believe PIKTOR has several characteristics that may combine to create a differentiated profile within the MNI class specifically in the HR+/HER2- breast cancer setting:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Its oral formulation may enable the establishment of an all oral MNI-based treatment regimen for advanced HR+/HER2- breast cancer that would untether patients from mandatory in-patient infusion treatment

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Low levels of stomatitis at the RP2D — 6% any grade observed in the Phase 1b trial and 13.6% any grade in the January 2026 FTH-PIK-201 data snapshot — that may reduce the need for four times daily prophylactic treatment with a corticosteroid mouthwash

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•A PK/PD profile that we believe, based on our analysis of publicly available data, may offer two key advantages over other developmental MNIs: first, PIKTOR's oral intermittent dosing schedule is designed to maintain plasma concentrations at or above the IC90 efficacy threshold for approximately two to three times longer per month; and second, PIKTOR's lower required dose levels result in a substantially lower ratio of peak drug concentration (Cmax) to IC90, which we believe may reduce the risk of concentration-dependent toxicities

***Planned Study FTH-PIK-101***

Study FTH-PIK-101 is our planned Phase 1b open-label, dose escalation trial of PIKTOR in advanced HR+/HER2- breast cancer. The purpose of this study is to evaluate PIKTOR's safety and preliminary efficacy in combination with fulvestrant, +/- palbociclib, in advanced HR+/HER2- metastatic breast cancer patients who have failed prior systemic therapies.

We expect that the study will evaluate escalating doses of PIKTOR (between 2mg and 4mg of sapanisertib and between 200mg and 300mg of serabelisib) administered three days per week/four weeks per month over 28-day cycles with:

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Cohort A:** 500mg of fulvestrant alone

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Cohort B:** 500mg fulvestrant plus 125mg of palbociclib

The Phase 1b component of the study is anticipated to enroll up to six adult participants per dose level in each cohort, up to a total of 36 patients. Pending the successful establishment of the RP2D for each cohort in the Phase 1b portion of the trial, we intend to subsequently enroll at least two expansion cohorts of approximately 30 patients each under a future amendment in Phase 2. We may initiate additional dose escalation cohorts with other investigational agents under a future amendment.

We intend to initiate this trial in the first half of 2026. We anticipate announcing interim data from the dose escalation portion of the trial, and initiating the expansion cohorts, in 2027 and announcing data from the expansion cohorts in 2028.

***Advanced Endometrial Cancer***

***Disease Overview and Unmet Need***

Endometrial cancer is the fourth most common cancer in women in the United States, with approximately 62,000 new diagnoses expected in 2026. Between 10,000 and 15,000 women annually will experience advanced disease either at initial diagnosis or due to progression. For these patients, the expected survival rate at five years is 18%.

At least one PI3K/AKT/mTOR pathway mutation is present in approximately 80% of endometrial tumors, however, there are currently no approved PI3K/AKT/mTOR pathway inhibitors for endometrial cancer.

***Current Treatment Options***

The current first-line standard of care regimen for advanced endometrial cancer is chemotherapy, carboplatin plus paclitaxel, combined with an immune checkpoint inhibitor. For patients who progress, second-line treatment consists of pembrolizumab combined with the multi kinase inhibitor lenvatinib, which demonstrated an ORR of 30% with PFS of 6.6 months (HR 0.60) in its pivotal trial, KEYNOTE-775, for which the first-line regimen did not yet include checkpoint inhibitors. If patients cannot tolerate lenvatinib/pembrolizumab or are not expected to respond to a second course of checkpoint inhibitor therapy, the use of single agent chemotherapy, which produced an ORR of 14.7% and PFS of 3.8 months as the control arm in KEYNOTE-775, is recommended.

***PIKTOR's Development Rationale***

As described in the Phase 1b results above, PIKTOR demonstrated an 80% ORR in five heavily pretreated endometrial cancer patients in Study X31025, including three complete responses, with median PFS of 11 months. We believe these results, combined with preclinical data demonstrating dose dependent inhibitory activity in four endometrial cancer preclinical models (HEC1B, MFE280, MFE296, and AN3CA) in combination with paclitaxel, support our plans to further evaluate PIKTOR in this setting.

![img84782739_12.jpg](img84782739_12.jpg)

**Endometrial tumor mutations and response status from Phase 1b trial, X31025**

*Source: Starks DC, Rojas-Espaillat L, Meissner T, Williams CB. Phase I dose escalation study of dual PI3K/mTOR inhibition by Sapanisertib and Serabelisib in combination with paclitaxel in patients with advanced solid tumors. Gynecologic Oncology. 2022 Jul 15. Data cutoff per publication October 1, 2021. \*Updated follow-up data obtained through unpublished communication with the study investigators. Single-agent chemotherapy reference line (~4 months PFS) represents the approximate median PFS for the chemotherapy control arm (investigator's choice of doxorubicin 60 mg/m² IV every 3 weeks or paclitaxel 80 mg/m² IV weekly, 3 weeks on/1 week off) in the pMMR population of KEYNOTE-775 (Makker et al., NEJM* 

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*2022). Abbreviations: LOT = Lines of Therapy; ORR = Objective Response Rate; CBR = Clinical Benefit Rate; PFS = Progression-Free Survival; OS = Overall Survival.*

![img84782739_13.jpg](img84782739_13.jpg)

**Preclinical dose-dependent inhibitory activity in endometrial cancer models in combination with paclitaxel**

*Source: Tyrakis et al., British Journal of Cancer, 2025; 133: 144–154. Cell lines tested: HEC1B, MFE280, MFE296, AN3CA. Dose-response curves: Serabelisib dosed at 0 - 6uM, sapanisertib dosed at 0 - 30nM, paclitaxel dosed within the range 0.001nmol/L-100umol/L. Cells exposed to drugs for 3 days (72 hours). Resorufin Fluorescence at 600-620 nm used to quantify cell number. PI3K-pathway mutation status of the cell lines is shown in the IC50 table above.*

Based on these results, we believe PIKTOR may offer improved outcomes for second-line advanced endometrial cancer patients.

We also see a potential first-line opportunity for PIKTOR in the genetically defined subpopulation of patients whose tumors are classified as mismatch repair proficient, or MMR-p. These patients constitute approximately 70% of the overall advanced endometrial cancer population and their tumors have been shown to respond less favorably to immune therapy in multiple trials across tumor types than patients whose tumors are classified as mismatch repair deficient, or MMR-d.

***Study FTH-PIK-201***

Study FTH-PIK-201 is our ongoing single arm Phase 2 study of 3mg/200mg of PIKTOR (3 days a week) in combination with 80 mg/m² of paclitaxel (weekly) in endometrial cancer. The study consists of 40 endometrial cancer patients with a confirmed PI3K/AKT/mTOR pathway mutation who have previously been treated with checkpoint inhibitors and carboplatin. There is also an optional sub-study available to enrollees to combine an insulin suppressing diet with their treatment.

The primary endpoint of the trial is ORR with key secondary endpoints: PFS, OS, CBR, Duration of Response, or DOR, and safety/tolerability.

We have initiated this Phase 2 trial, with topline data currently anticipated by year-end 2026. We anticipate dosing the last patient in this trial and announcing longer term follow-up data in 2027.

***Potential Future Indications***

Beyond advanced HR+/HER2- breast cancer and advanced endometrial cancer, we may also consider developing PIKTOR in additional indications where there are large unmet needs, PI3K/AKT/mTOR pathway activity is implicated in disease progression, and PIKTOR or its components have displayed clinical activity.

Our potential interest in ovarian cancer is driven by encouraging activity in the ovarian patients in the investigator-initiated Phase 1b trial (Study X31025), described above, as well as the results of the Phase 2 "DICE" trial. The DICE trial was a randomized controlled investigator-initiated trial of 134 ovarian cancer patients designed to evaluate the addition of 4 mg of sapanisertib in combination with 80 mg/m² of paclitaxel versus 80 mg/m² of paclitaxel alone. The results of the trial, which were presented as a late-breaking oral presentation at the annual meeting of the European Society for Medical Oncology, or ESMO, in 2025, met the trial's pre-specified primary endpoint. Addition of sapanisertib to paclitaxel was associated with a 34% decrease in risk of disease progression (HR=0.66; pre-specified 90% CI: 0.45–0.96; one-sided p=0.07). Mean PFS was 5.8 months for patients treated with sapanisertib and paclitaxel versus 4.0 months for patients treated with paclitaxel alone. The combination of sapanisertib and paclitaxel was generally well tolerated, with Grade 3/4 adverse events occurring in 7% of patients in the combination arm compared to 6.6% of patients in the paclitaxel monotherapy arm.

PIKTOR has also demonstrated clinical activity in certain genetically defined subtypes of lung cancer. Depending on discussions with regulatory authorities, we intend to explore the possibility of initiating future clinical trials of PIKTOR in this setting.

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We have not yet initiated an independent clinical trial of PIKTOR in either ovarian cancer or lung cancer, and any future development in these settings will depend on further discussions with regulatory authorities and the results of our ongoing trials in our lead indications.

**Other Pipeline Programs**

***Faeth Pipeline Programs***

We have created a multi-asset development portfolio utilizing our expertise in cancer biology and metabolic disease to generate compelling pipeline assets by identifying additional opportunities to address significant unmet needs. Our platform seeks to identify and exploit potential cancer cell vulnerabilities to create integrated treatment regimens to deny tumors the signaling pathways and nutrients they depend upon to proliferate.

***NEAAR (Non Essential Amino Acid Restriction)***

We call our second pipeline program NEAAR. This regimen restricts patient intake of specific non-essential amino acids that we have determined tumors use to support proliferation. NEAAR has demonstrated pre-clinically that, by itself, it can suppress tumor growth and increase survival, and in combination, can increase the sensitivity of cancer cells to chemotherapies, radiotherapy and targeted therapies.

***IEM (Inborn Errors of Metabolism)***

Our broad understanding of metabolic disease has enabled our third program, IEM, which may improve treatment options for a rare inherited metabolic disease, Type I Tyrosinemia, by eliminating an off-target effect of the current standard of care drug that we believe may cause neurocognitive impairment. In preclinical models, our IEM program has shown equivalence to current standard of care in rescuing underlying disease pathology while maintaining normal neurocognitive function.

***Sensei Legacy Programs***

In addition to PIKTOR and the Faeth pipeline programs described above, our pipeline includes programs that preceded the Acquisition. We are completing a Phase 1/2 trial of solnerstotug (formerly SNS-101), our conditionally active monoclonal antibody targeting the immune checkpoint VISTA. As of March 23, 2026, seven patients remain on study in the expansion portion of the trial. We also have three preclinical-stage conditionally active antibody programs: SNS-102 (targeting VSIG4), SNS-103 (targeting CD39), and SNS-201, a bispecific antibody designed to conditionally activate CD28 through monovalent CD28 engagement and bivalent pH-selective VISTA binding.

**Competition**

The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on intellectual property. While we believe our deep scientific knowledge of oncology paired with our differentiated lead product candidate, PIKTOR, provides a strong competitive advantage, we face competition from many different sources, including pharmaceutical and biotechnology companies, academic institutions, governmental agencies and public and private research institutions.

Our competitors may have significantly greater financial resources, established presence in the market and expertise in research and development, manufacturing, preclinical and clinical testing, obtaining regulatory approvals and reimbursement and marketing approved products than we do. They may also compete in recruiting and retaining qualified scientific, sales, marketing and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to or necessary for our product candidates. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

Our commercial opportunity can be reduced or eliminated if competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop. Competitors also may obtain U.S. Food and Drug Administration, or FDA, or other regulatory approval for their products more rapidly or earlier than us, which could result in our competitors establishing a strong market position before we are able to enter the market. Additionally, technologies developed by our competitors may render our potential product candidates uneconomical or obsolete and we may not be successful in marketing our product candidates against competitors.

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***PI3K/AKT/mTOR Competitive Landscape***

In addition to the five approved SNI agents described above, our comprehensive search of available resources and databases revealed there are several additional product candidates in clinical development which could pose a direct competitive threat to PIKTOR, particularly for the treatment of advanced HR+/HER2- breast cancer. These product candidates include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Pan-PI3K/mTOR Inhibitors**

o**Gedatolisib**, an IV pan-PI3K/mTOR inhibitor from Celcuity, whose New Drug Application for HR+/HER2-, PIK3CA wild-type metastatic breast cancer was accepted by the FDA in January 2026 with Priority Review and a Prescription Drug User Fee Act goal date of July 17, 2026. Gedatolisib's clinical efficacy data is discussed in the context of MNI class validation in the breast cancer development section above.

o**Paxalisib**, an oral brain penetrant pan-PI3K/mTOR inhibitor from Kazia Therapeutics, currently in Phase 3 trials in glioblastoma.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Mutant-PI3K**α **Inhibitors**

o**Zovegalisib**, an oral inhibitor of mutant PI3Kα from Relay Therapeutics, currently in Phase 3 trials for advanced HR+/HER2- breast cancer.

o**Tersolisib**, an oral inhibitor of mutant PI3Kα from Eli Lilly, currently in Phase 3 trials for HR+/HER2- breast cancer.

o**SNV4818**, an oral inhibitor of mutant PI3Kα acquired by Novartis from Synnovation Therapeutics in March 2026, currently in Phase 1/2 trials for HR+/HER2- breast cancer and other advanced solid tumors.

o**OKI-219**, an oral inhibitor of mutant PI3Kα from OnKure Therapeutics, currently in Phase 1a/1b trials for HR+/HER2- metastatic breast cancer and other advanced solid tumors as monotherapy, in combination with fulvestrant, and in triplet combinations with fulvestrant/ribociclib and trastuzumab/tucatinib.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**AKT Inhibitor**

o**Afuresertib**, an oral pan AKT inhibitor from Laekna Therapeutics, currently in Phase 3 trials for advanced HR+/HER2- breast cancer.

**Intellectual Property**

Intellectual property is of vital importance in our field and in biotechnology generally. We seek to protect and enhance proprietary technology, inventions, and improvements that are commercially important to the development of our business by seeking, maintaining, and defending patent rights, whether developed internally or licensed from third parties. We will also seek to rely on regulatory protection afforded through inclusion in expedited development and review, data exclusivity, market exclusivity and patent term extensions where available.

Wherever possible, we pursue claims directed to the clinical product or product candidates. Such applications may not result in issued patents and, even if patents do issue, such patents may not be in a form that will provide us with meaningful protection for our product. We also rely on trade secrets that may be important to the development of our business. Trade secrets are difficult to protect and provide us with only limited protection.

***PIKTOR***

We hold our rights to serabelisib and sapanisertib under exclusive license and asset purchase agreements with Takeda Pharmaceutical Company Limited, or Takeda, and its subsidiary Millennium Pharmaceuticals, Inc., or Millennium Takeda, as described in the "Material Agreements" section below. We are actively building our intellectual property portfolio around PIKTOR to protect the composition of matter of both serabelisib and sapanisertib as well as for its method of use in the types of cancer in which we intend to develop it. Our patent portfolio for PIKTOR, as of March 23, 2026, contains 13 issued U.S. patents, four pending U.S. applications, and three pending patent cooperation treaty applications that are either solely owned by us or in-licensed, as well as certain foreign counterparts of a subset of these patent applications in foreign countries, including in Algeria, Australia, Brazil, Canada, Chile, China, Colombia, Europe, Eurasia, Georgia, Hong Kong, India, Indonesia, Israel, Japan, Kazakhstan, Macao, Malaysia, Mexico, Morocco, New Zealand, Nigeria, Peru, Philippines, Russia, Singapore, South Africa, South Korea, Tunisia, Ukraine, Uzbekistan, and Vietnam. For PIKTOR, these patents and patent applications are directed to compositions, methods of manufacturing, and methods of treating cancer. If issued, the 20-year term expiration dates from which our patents will expire are between 2027 and 2046, not including any extension of the patent term that may be available in certain jurisdictions. We continue to seek to maximize the scope of our patent protection for PIKTOR.

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***Sensei Legacy Programs***

Prior to the Acquisition, we developed a portfolio of intellectual property relating to our TMAb conditionally active biologic platform and product candidates. As of March 23, 2026, our solely owned legacy patent estate included one issued U.S. patent, one pending U.S. patent application, and nine international patent applications. We also co-own five pending U.S. patent applications and five pending international patent applications.

We own one U.S. non-provisional and eight international patent applications relating to composition of matter of our solnerstotug product candidate and method claims including use in combination with immune checkpoint protein inhibitors. Subject to payment of required maintenance fees, annuities, and other charges, any patents, if issued, are projected to expire in 2042.

***Takeda License Agreement***

We are party to a license agreement with Takeda that was originally entered into in March 2019, or the Takeda License Agreement, between Takeda and Petra Pharma Corporation, or Petra, which was subsequently assigned by Petra to Ravenna Pharmaceuticals, Inc., or Ravenna, and later acquired by Faeth in February 2021 in connection with its acquisition of assets related to serabelisib pursuant to an asset purchase agreement with Ravenna.

Under the Takeda License Agreement, we are granted an exclusive, royalty-bearing license, with the right to grant sublicenses, under certain patents and know-how controlled by Takeda to research, develop, make, have made, import, export, use, have used, sell, have sold, offer for sale, or otherwise dispose of and commercialize serabelisib and certain back-up compounds, and analogs, derivatives, fragments or modifications that we obtain from serabelisib or such back-up compounds, or, collectively, the Serabelisib Compounds, and products comprising Serabelisib Compounds, or Serabelisib Products, for all human therapeutic uses excluding certain non-oncology indications, or the Serabelisib Field, throughout the world.

We are solely responsible, at our cost, for the development, manufacture, and commercialization of the Serabelisib Compounds and Serabelisib Products in the Serabelisib Field. We are obligated to use commercially reasonable efforts to develop and commercialize at least one Serabelisib Product.

We are obligated to pay Takeda tiered single-digit royalties on annual net sales of Serabelisib Products (except for PIKTOR Products, the royalties for which are set forth in the Takeda Letter Agreements described below). The royalty payments are subject to reduction under certain customary circumstances. On a Serabelisib Product-by-Serabelisib Product and country-by-country basis, our royalty payment obligations commence on the first commercial sale of such Serabelisib Product in the applicable country until the latest to occur of (a) the last-to-expire valid claim within the licensed patents covering such Serabelisib Product in the applicable country, (b) the expiration of any applicable regulatory exclusivity for such Serabelisib Product in the applicable country and (c) ten (10) years after the first commercial sale of such Serabelisib Product in the applicable country. We are obligated to pay Takeda development, regulatory and sales milestone payments for Serabelisib Products under the Takeda Letter Agreements, as described below.

The Takeda License Agreement will remain in effect on a Serabelisib Product-by-Serabelisib Product and country-by-country basis until expiration of all royalty payment obligations, unless earlier terminated. Following expiration, the licenses granted to us become fully-paid, royalty-free, irrevocable and perpetual.

Either party may terminate the Takeda License Agreement in whole or, to the extent applicable to the subject matter of the breach, on a Serabelisib Product-by-Serabelisib Product or country-by-country basis, in the event of the other party's uncured material breach. Either party may also terminate the Takeda License Agreement in its entirety in connection with the other party's insolvency. Takeda may terminate the Takeda License Agreement if we challenge a licensed patent.

If we abandon development and commercialization of all Serabelisib Compounds and Serabelisib Products, Takeda has the right to terminate the Takeda License Agreement and assume development and commercialization responsibilities for the Serabelisib Compounds and Serabelisib Products. If Takeda elects to take over development and commercialization responsibilities, we are required to engage in good faith discussions to grant Takeda a license under certain patents and know-how that we control that are related to the Serabelisib Products or necessary or useful for the exploitation of the Serabelisib Products, but we are not obligated to grant such a license.

***Amended and Restated Asset Purchase Agreement with Millennium Takeda***

We are party to an amended and restated asset purchase agreement with Millennium Takeda that was originally entered into in May 2023, or the Millennium Takeda Asset Purchase Agreement, between Millennium Takeda and Calithera Biosciences, Inc., or Calithera, which was acquired by Faeth in May 2023 in connection with its acquisition of assets related to sapanisertib pursuant to an asset purchase agreement with Calithera.

Pursuant to the Millennium Takeda Asset Purchase Agreement, Millennium Takeda assigned to Calithera certain know-how and certain patents and patent applications, or the Assigned Patent Rights, related to sapanisertib that Faeth subsequently acquired from

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Calithera in May 2023 under the asset purchase agreement. Under the Millennium Takeda Asset Purchase Agreement, we are also granted a non-exclusive license, with the right to grant sublicenses, under certain patent rights and know-how controlled by Millennium Takeda to research, develop, make, have made, use and import sapanisertib, compounds that are disclosed or claimed in any Assigned Patent Right that also discloses sapanisertib and certain other pharmaceutical forms of sapanisertib or such compounds, or, collectively, the Sapanisertib Program Molecules, and to research, develop, make, have made, use, sell, offer for sale, and import products containing or comprising Sapanisertib Program Molecules, or the Sapanisertib Products, in any therapeutic, prophylactic, preventative or diagnostic use in or for animals, including humans, or the Sapanisertib Field, throughout the world.

We are obligated to use commercially reasonable efforts to research and develop, including to obtain regulatory approval for, and upon obtaining regulatory approval to commercialize at least one Sapanisertib Product in each of the United States, Japan and at least three countries selected from United Kingdom, Germany, France, Spain and Italy.

We are obligated to pay Millennium Takeda tiered high single-digit to low double-digit royalties on annual net sales of all Sapanisertib Products (except for PIKTOR Products, the royalties for which are set forth in the Takeda Letter Agreements described below). On a Sapanisertib Product-by-Sapanisertib Product and country-by-country basis, our obligation to pay Millennium Takeda royalties commences on the first commercial sale of such Sapanisertib Product in the applicable country until the latest to occur of (a) the last-to-expire valid claim within the Assigned Patents and licensed patents covering such Sapanisertib Product in the applicable country, (b) the expiration of any applicable regulatory exclusivity for such Sapanisertib Product in the applicable country and (c) ten (10) years after the first commercial sale of such Sapanisertib Product in the applicable country. The royalty payments are subject to reduction under certain customary circumstances. Upon expiration of our royalty payment obligations with respect to a Sapanisertib Product and a country, the license granted to us for such Sapanisertib Product in such country will become fully-paid, perpetual, and irrevocable. We are also obligated to pay Takeda development, regulatory and sales milestone payments for Sapanisertib Products under the Takeda Letter Agreements described below.

The Millennium Takeda Asset Purchase Agreement will remain in effect until expiration of our obligations to make royalty payments to Takeda, unless earlier terminated. Either party may terminate the Millennium Takeda Asset Purchase Agreement in connection with the other party's uncured material breach or insolvency. Upon termination of the Millennium Takeda Asset Purchase Agreement, all licenses granted by Millennium Takeda to us automatically terminate. Upon Millennium Takeda's request after termination, we are required to assign to Millennium Takeda the acquired assets and certain intellectual property generated in the performance of the agreement that solely relate to, or were used by us or on our behalf, Sapanisertib Program Molecules and Sapanisertib Products and all regulatory materials that are needed to continue fully exploiting Sapanisertib Program Molecules and Sapanisertib Products.

***Letter Agreements with Takeda and Millennium Takeda***

We are party to a letter agreement with Millennium Takeda that was entered into in May 2023, or the First Takeda Letter Agreement, to amend the Millennium Takeda Asset Purchase Agreement and to a letter agreement with Takeda and Millennium Takeda that was entered into in January 2026, or the Second Takeda Letter Agreement, to amend the Takeda License Agreement, the Millennium Takeda Asset Purchase Agreement, and the First Takeda Letter Agreement. The First Takeda Letter Agreement and the Second Takeda Letter Agreement are referred to collectively as the "Takeda Letter Agreements."

Pursuant to the Takeda Letter Agreements, we are obligated to pay Takeda and Millennium Takeda up to an aggregate of $119.0 million in development, regulatory, and commercial launch milestone payments and up to an aggregate of $250.0 million in sales milestone payments for PIKTOR and any other products that contain both a Serabelisib Compound and a Sapanisertib Program Molecule as the only active ingredients, or collectively PIKTOR Products, Serabelisib Products, and Sapanisertib Products.

We are also obligated to pay Takeda and Millennium Takeda tiered single-digit royalties on annual net sales of PIKTOR Products. On a PIKTOR Product-by-PIKTOR Product and country-by-country basis, our obligation to pay royalties commences on the first commercial sale of such PIKTOR Product in the applicable country and continues until the latest to occur of (a) the last-to-expire valid claim within the Assigned Patents under the Millennium Takeda Asset Purchase Agreement or the licensed patents under the Millennium Takeda Asset Purchase Agreement or the Takeda License Agreement, in each case, covering such PIKTOR Product in the applicable country, (b) the expiration of any regulatory exclusivity for such PIKTOR Product in the applicable country and (c) ten (10) years after the first commercial sale of such PIKTOR Product in the applicable country. The royalty payments for PIKTOR Products are subject to reduction under certain customary circumstances.

The Second Takeda Letter Agreement specifies that PIKTOR Products are considered Serabelisib Products under the Takeda License Agreement and Sapanisertib Products under the Millennium Takeda Asset Purchase Agreement. The Second Takeda Letter Agreement also amends the Takeda License Agreement and the Millennium Takeda Asset Purchase Agreement to add certain specific IND-related materials for PIKTOR Products controlled by Takeda or Millennium Takeda to the know-how licensed to us under those agreements.

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***University of California License Agreement***

We are party to an exclusive license agreement with The Regents of the University of California, or The Regents, that was originally entered into in August 2007 between The Regents and Intellikine, Inc., or Intellikine, and amended in March 2009, July 2009, November 2010, September 2014, August 2021 and February 2022, or the UC License Agreement, which was subsequently assigned by Intellikine to Millennium Takeda, which was subsequently assigned by Millennium Takeda to Calithera and later acquired by Faeth Therapeutics in May 2023 in connection with its acquisition of assets related to sapanisertib pursuant to its asset purchase agreement with Calithera.

Under the UC License Agreement, we are granted a license, with the right to grant sublicenses, to make, have made, use, sell, offer for sale and import (a) products that are covered by the claims of certain patent rights controlled by The Regents, or the UC Licensed Products, or that are produced by methods covered by such patent rights, or the UC Licensed Methods, and services that involve UC Licensed Products or UC Licensed Methods or that involve certain materials or know-how controlled by The Regents, or the UC Licensed Services, and (b) to practice the UC Licensed Methods, in each case, (a) and (b), in the United States and all other countries where The Regents may grant such licenses, or the UC Licensed Territory, for all fields and all uses, or the UC Licensed Field. The license granted to us is exclusive with respect to such patent rights and is non-exclusive with respect to such know-how.

We are obligated to proceed diligently with the development, manufacture, and sale of UC Licensed Products and UC Licensed Services and earnestly and diligently to market UC Licensed Products and UC Licensed Services in quantities intended to be sufficient to meet market demand. We are also required to meet specific development diligence timelines for certain UC Licensed Products, which may be extended subject to payment of an extension fee. If we fail to meet, subject to a cure period, or extend such timelines, The Regents have the right to terminate the UC License Agreement or to convert the licenses to a non-exclusive basis with respect to the relevant UC Licensed Products.

We are required to pay The Regents an annual license maintenance fee of $25,000 until we begin paying royalties under the UC License Agreement. We are also required to pay The Regents a low double-digit percentage of income that we receive from our sublicensees if we sublicense the rights granted to us under the UC License Agreement. We are also obligated to pay The Regents tiered low single-digit royalties based on cumulative net sales of UC Licensed Products, UC Licensed Services and UC Licensed Methods. Beginning with the year of the first commercial sale of the UC Licensed Product and continuing until expiration of all licensed patent rights, we are required to pay The Regents a minimum annual royalty of $25,000, which will be credited against the royalties owed to The Regents. The royalty payments owed to The Regents are subject to reduction under certain customary circumstances. On a UC Licensed Product-by-UC Licensed Product, UC Licensed Service-by-UC Licensed Service, UC Licensed Method-by-UC Licensed Method and country-by-country basis, our obligation to pay royalties commences on the first commercial sale of such UC Licensed Product, UC Licensed Service, or UC Licensed Method, as applicable, in the relevant country and continues until expiration of the last-to-expire valid claim within the licensed patent rights that covers such UC Licensed Product, UC Licensed Service, or UC Licensed Method, as applicable, in the relevant country. We are also obligated to pay The Regents up to $800,000 in development and regulatory milestones payments for certain UC Licensed Products.

The UC License Agreement will remain in effect until expiration or abandonment of the licensed patents. The UC License Agreement will automatically terminate in connection with our insolvency. The Regents have the right to terminate the UC License Agreement in its entirety or with respect to specific licensed patents based on our uncured material breach. We have the right to terminate the UC License Agreement in its entirety or with respect to specific licensed patents on a country-by-country basis, upon advance written notice to The Regents.

***Adimab Agreement***

On July 14, 2021, we entered into a First Amended and Restated Collaboration Agreement, or the Adimab Agreement, with Adimab, LLC, or Adimab. Under the Adimab Agreement, we selected a number of biological targets against which Adimab used its proprietary platform technology to discover and/or optimize antibodies based upon mutually agreed upon research plans, and we have the ability to select a specified number of additional biological targets against which Adimab will provide additional antibody discovery and optimization services. During the research term and evaluation term for a given research program with Adimab, or Research Program, we have a non-exclusive worldwide license under Adimab's technology to perform certain research activities and to evaluate the program antibodies to determine whether we want to exercise our option to obtain an exclusive license to exploit such antibodies, referred to herein as a "Development and Commercialization Option."

Pursuant to the Adimab Agreement, we previously paid Adimab a one-time, non-creditable, non-refundable technology access fee of $50,000. We are also obligated to make certain technical milestone payments to Adimab for each Research Program up to $275,000. Upon exercise of a Development and Commercialization Option, we are obligated to pay to Adimab a non-creditable, nonrefundable option exercise fee of $500,000 plus an amount equal to any technical milestone payment which was not previously paid with respect to such Research Program and less any option extension fees paid with respect to such Research Program. On a product-by-product basis, we will pay Adimab upon the achievement of various clinical and regulatory milestone events with total milestone payments up to an aggregate of $13.3 million for the first product from a Research Program and up to an aggregate of $6.6 million for

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each subsequent product from a Research Program. For any product that is commercialized, on a country-by-country and product-by-product basis, we are obligated to pay to Adimab a low-to-mid single-digit percentage of annual worldwide net sales of such product during the applicable royalty period in each country.

Solnerstotug is subject to the terms of the Adimab Agreement, and in December 2022 we exercised our Development and Commercialization Option for the Research Program from which solnerstotug was generated. To date, we have paid $1,875,000 to Adimab pursuant to the Adimab Agreement for the technology access fee, Development and Commercialization Option, program delivery fees and a milestone payment for the first patient dosed in our Phase 1/2 clinical trial of solnerstotug.

**General**

The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained. In most countries in which we file, including the United States, the patent term is 20 years from the earliest date of filing a non-provisional patent application. In the United States, a patent's term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the U.S. Patent and Trademark Office, or USPTO, in examining and granting a patent, or may be shortened if a patent is terminally disclaimed over an earlier filed patent. In the United States, the patent term of a patent that covers an FDA-approved drug may also be eligible for patent term extension, which permits patent term restoration as compensation for the patent term lost during the FDA regulatory review process. The Hatch-Waxman Act permits a patent term extension of up to five years beyond the expiration of the patent. The length of the patent term extension is related to the length of time the drug is under regulatory review. Patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent applicable to an approved drug may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended. Similar provisions are available in Europe and other foreign jurisdictions to extend the term of a patent that covers an approved drug. In the future, if and when our products receive FDA approval, we expect to apply for patent term extensions on patents covering those products. We plan to seek patent term extensions to any issued patents we may obtain in any jurisdiction where such patent term extensions are available, however there is no guarantee that the applicable authorities, including the FDA in the United States, will agree with our assessment of whether such extensions should be granted, and if granted, the length of such extensions.

We expect to file additional patent applications in support of current and new clinical candidates as well as new platform and core technologies. Our commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of our current and future product candidates and the methods used to develop and manufacture them, as well as successfully defending these patents against third-party challenges and operating without infringing on the proprietary rights of others. Our ability to stop third parties from making, using, selling, offering to sell or importing our products depends on the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities. We cannot be sure that patents will be granted with respect to any of our pending patent applications or with respect to any patent applications filed by us in the future, nor can we be sure that any patents that may be granted to us in the future will be commercially useful in protecting our product candidates, discovery programs and processes. For this and more comprehensive risks related to our intellectual property, please see "Risk Factors—Risks Related to Our Intellectual Property."

We maintain a portfolio of registered and pending trademarks to protect our brand identity. In addition to patent and trademark protection, we rely upon unpatented trade secrets and know-how and continuing technological innovation to develop and maintain our competitive position. We seek to protect our proprietary information, in part, using confidentiality agreements with our commercial partners, collaborators, employees, and consultants. These and other agreements, such as invention assignment agreements, grant us ownership of technologies that are developed through a relationship with a third party. It is our policy to require our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. These agreements provide that all confidential information concerning our business or financial affairs developed or made known to the individual during the course of the individual's relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances. Our agreements with employees also provide that all inventions conceived by the employee in the course of employment with us or from the employee's use of our confidential information are our exclusive property. However, such confidentiality agreements and invention assignment agreements can be breached and we may not have adequate remedies for any such breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors.

**Chemistry, Manufacturing, and Controls**

We believe the quality and amount of the current sapanisertib and serabelisib drug supply (DS) and drug product (DP) is appropriate for our current and expected clinical trials. Further CMC development is ongoing, including activities leading to the manufacture of batches in support of potential future registrational trials, New Drug Application, or NDA, submissions, and required regulatory validation of DS/DP manufacturing processes in anticipation of any potential commercial launch.

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**Commercial Opportunity**

We believe the commercial potential for PIKTOR, if approved, in advanced HR+/HER2- breast cancer and endometrial cancer is substantial given the prevalence of the conditions, the urgency of the unmet medical need and the potential breadth of PIKTOR's benefit across these substantial patient populations. In the United States alone, we believe the total addressable market for our currently targeted indications, second-line HR+/HER2- breast cancer and second-line advanced endometrial cancer, is approximately $6 billion based on our analysis of the patient populations and current pricing paradigms for these treatment settings, as of 2026, as well as third party estimates of these markets and the publicly disclosed sales totals achieved by currently available treatments for these settings. Within this overall total, HR+/HER2- breast cancer accounts for approximately $5 billion and advanced endometrial cancer the remaining $1 billion. Given our stage of development, however, we have not yet established either a commercial organization or distribution capabilities.

**Government Regulation**

Government authorities in the United States, at the federal, state and local level and other countries extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, marketing and export and import of products such as those we are developing. A new drug must be approved by the FDA through the New Drug Application, or NDA, process before it may be legally marketed in the United States.

***U.S. Drug Development Process***

In the United States, the FDA regulates drugs under the federal Food, Drug and Cosmetic Act, or FDCA, and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state and local statutes and regulations require the expenditure of substantial time and financial resources. The process required by the FDA before a drug may be marketed in the United States generally involves the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•completion of preclinical laboratory tests, animal studies and formulation studies in accordance with Good Laboratory Practice regulations and other applicable regulations;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•submission to the FDA of an Investigational New Drug application, or IND, which must become effective before human clinical trials may begin;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•approval by an Institutional Review Board, or IRB, or ethics committee at each clinical site before each trial may be initiated;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•performance of adequate and well-controlled human clinical trials in accordance with Good Clinical Practice, or GCP, regulations to evaluate the safety and efficacy of the product candidate for its intended use;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•submission to the FDA of an NDA after completion of all pivotal trials;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•satisfactory completion of an FDA advisory committee review, if applicable;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with current Good Manufacturing Practice, or cGMP, regulations to assure that the facilities, methods and controls are adequate to preserve the drug's identity, strength, quality and purity;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•satisfactory completion of potential inspection of selected clinical investigation sites to assess compliance with GCP regulations; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•FDA review and approval of the NDA to permit commercial marketing of the product for particular indications for use in the United States.

Once a product candidate is identified for development, it enters the preclinical testing stage. Preclinical tests include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies. An IND sponsor must submit the results of the preclinical tests, together with manufacturing information and analytical data, to the FDA as part of an IND. An IND is a request for allowance from the FDA to administer an investigational drug product to humans. An IND will also include a protocol detailing, among other things, the objectives of the clinical trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated, if the trial includes an efficacy evaluation. Some preclinical testing may continue even after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, places the clinical trial on a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Clinical holds also may be imposed by the FDA at any time before or during clinical trials due to safety concerns about

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ongoing or proposed clinical trials or non-compliance with specific FDA requirements, and in such case, the trials may not begin or continue until the FDA notifies the sponsor that the hold has been lifted.

All clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with GCP regulations, which include the requirement that all research subjects provide their informed consent in writing for their participation in any clinical trial. Clinical trials must be conducted under protocols detailing the objectives of the trial, dosing procedures, subject selection and exclusion criteria and the safety and effectiveness criteria to be evaluated. Each protocol must be submitted to the FDA as part of the IND, and a separate submission to the existing IND must be made for each successive clinical trial conducted during product development and for any subsequent protocol amendments. While the IND is active, progress reports summarizing the results of the clinical trials and nonclinical studies performed since the last progress report, among other information, must be submitted at least annually to the FDA and written IND safety reports must be submitted to the FDA and investigators for serious and unexpected suspected AEs, findings from other studies suggesting a significant risk to humans exposed to the same or similar drugs, findings from animal or *in vitro* testing suggesting a significant risk to humans and any clinically important increased incidence of a serious suspected adverse reaction compared to that listed in the protocol or investigator brochure.

Furthermore, an IRB at each institution participating in the clinical trial must review and approve each protocol before a clinical trial commences at that institution and must also approve the information regarding the trial and the consent form that must be provided to each trial subject or his or her legal representative, monitor the trial until completed and otherwise comply with IRB regulations. The FDA or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB's requirements or if the drug has been associated with unexpected serious harm to patients. In addition, some clinical trials are overseen by an independent group of qualified experts organized by the sponsor, known as a data safety monitoring board or committee. Depending on its charter, this group may determine whether a trial may move forward at designated check points based on access to certain data from the trial. There are also requirements governing the reporting of ongoing clinical trials and clinical trial results to public registries, including *clinicaltrials.gov*.

Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Phase 1: The product candidate is initially introduced into healthy human subjects or patients with the target disease or condition, and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion and, if possible, to gain an early indication of its effectiveness.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Phase 2: The product candidate is administered to a limited patient population with a specified disease or condition to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product candidate for specific targeted diseases and to determine dosage tolerance and appropriate dosage.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Phase 3: The product candidate is administered to an expanded patient population to further evaluate dosage, to provide substantial evidence of efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk-benefit ratio of the product candidate and provide an adequate basis for product labeling.

Post-approval trials, sometimes referred to as Phase 4 trials, may be conducted after initial marketing approval. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of approval of an NDA.

Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP regulations. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final drug. In addition, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

***FDA Regulatory Framework for Fixed-Combination Prescription Drugs for Humans***

The FDA's regulation at 21 CFR § 300.50 governing fixed-combination drug products provides, among other things, that two or more drugs may be combined in a single dosage form when each component contributes to the claimed effects and the dosage of each component (amount, frequency, duration) is such that the combination is safe and effective for a significant patient population requiring such concurrent therapy as defined in the labeling for the drug. This rule is meant to ensure that any fixed-dose combination

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drug provides an advantage to the patient over and above that obtained when one of the individual ingredients is used in the usual safe and effective dose.

***U.S. Review and Approval Process***

The results of product development, preclinical and other non-clinical studies and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the drug, proposed labeling and other relevant information are submitted to the FDA as part of an NDA requesting approval to market the product. The submission of an NDA is subject to the payment of substantial user fees; a waiver of such fees may be obtained under certain limited circumstances.

Once an NDA has been submitted, the FDA conducts a preliminary review of the application within the first 60 days after submission, before accepting it for filing, to determine whether it is sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an NDA for filing. In this event, the NDA must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing. Once filed, the FDA reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and whether its manufacturing is cGMP-compliant to assure and preserve the product's identity, strength, quality and purity. Under the Prescription Drug User Fee Act, or PDUFA, guidelines that are currently in effect, the FDA has a goal of ten months from the date of "filing" of a standard NDA for a new molecular entity to review and act on the submission. This review typically takes twelve months from the date the NDA is submitted to FDA because the FDA has approximately two months to make a "filing" decision after the application is submitted.

The FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. Before approving an NDA, the FDA will typically inspect the facility or facilities where the product is manufactured. Additionally, before approving an NDA, the FDA may inspect one or more clinical trial sites to assure compliance with GCP regulations.

After the FDA evaluates an NDA and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will be produced, the FDA may issue an approval letter or a Complete Response Letter, or CRL. An approval letter authorizes commercial marketing of the drug with prescribing information for specific indications. A CRL indicates that the review cycle of the application is complete, and the application will not be approved in its present form. A CRL usually describes the specific deficiencies in the NDA identified by the FDA and may require additional clinical data, such as additional clinical trials or other significant and time-consuming requirements related to clinical trials, nonclinical studies or manufacturing. If a CRL is issued, the sponsor must resubmit the NDA addressing all of the deficiencies identified in the letter or withdraw the application. Even if such data and information are submitted, the FDA may decide that the NDA does not satisfy the criteria for approval.

If a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. In addition, the FDA may require a sponsor to conduct "Phase 4" testing, which involves clinical trials designed to further assess a drug's safety and/or effectiveness following NDA approval, and may require additional testing and surveillance programs to monitor the safety of approved products that have been commercialized. The FDA may also place other conditions on approval including the requirement for a risk evaluation and mitigation strategy, or REMS, to assure the safe use of the drug. If the FDA concludes a REMS is needed, the sponsor of the NDA must submit a proposed REMS. The FDA will not approve the NDA without an approved REMS, if required. A REMS could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of products.

In addition, the Pediatric Research Equity Act, or PREA, requires a sponsor to conduct pediatric clinical trials for most drugs, for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration. Under PREA, original NDAs and certain supplements must contain a pediatric assessment unless the sponsor has received a deferral or waiver. The required assessment must evaluate the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations and support dosing and administration for each pediatric subpopulation for which the product is deemed safe and effective. The sponsor or FDA may request a deferral of pediatric clinical trials for some or all of the pediatric subpopulations. A deferral may be granted for several reasons, including a finding that the drug is ready for approval for use in adults before pediatric clinical trials are complete or that additional safety or effectiveness data needs to be collected before the pediatric clinical trials begin. The FDA must send a non-compliance letter to any sponsor that fails to submit the required assessment, keep a deferral current or fails to submit a request for approval of a pediatric formulation.

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***Expedited Development and Review Programs***

The FDA has a number of programs intended to expedite the development or review of a marketing application for an investigational drug. For example, the fast track designation program is intended to expedite or facilitate the process for developing and reviewing product candidates that meet certain criteria. Specifically, investigational drugs are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition. The sponsor of a fast track product candidate has opportunities for more frequent interactions with the applicable FDA review team during product development and, once an NDA is submitted, the application may be eligible for priority review. With regard to a fast track product candidate, the FDA may consider for review sections of the NDA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable and the sponsor pays any required user fees upon submission of the first section of the NDA.

A product candidate intended to treat a serious or life-threatening disease or condition may also be eligible for breakthrough therapy designation to expedite its development and review. A product candidate can receive breakthrough therapy designation if preliminary clinical evidence indicates that the product candidate, alone or in combination with one or more other drugs or biologics, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. The designation includes all of the fast track program features, as well as more intensive FDA interaction and guidance beginning as early as Phase 1 and an organizational commitment to expedite the development and review of the product candidate, including involvement of senior managers.

Any product candidate submitted to the FDA for approval, including a product candidate with a fast track designation or breakthrough designation, may also be eligible for other types of FDA programs intended to expedite development and review, such as priority review and accelerated approval. An NDA is eligible for priority review if the product candidate is designed to treat a serious condition and, if approved, would provide a significant improvement in safety or efficacy compared to available therapies. The FDA will attempt to direct additional resources to the evaluation of a NDA designated for priority review in an effort to facilitate the review. The FDA endeavors to review applications with priority review designations within six months of the filing date as compared to ten months for review of new molecular entity NDAs under its current PDUFA review goals.

In addition, a product candidate may be eligible for accelerated approval. Drugs intended to treat serious or life-threatening diseases or conditions may be eligible for accelerated approval upon a determination that the product candidate has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments. As a condition of approval, the FDA generally requires that a sponsor of a drug receiving accelerated approval perform adequate and well-controlled confirmatory clinical trials, and may require that such confirmatory trials be underway prior to granting accelerated approval. Drugs receiving accelerated approval may be subject to expedited withdrawal procedures if the sponsor fails to conduct the required confirmatory trials in a timely manner or if such trials fail to verify the predicted clinical benefit. In addition, the FDA currently requires as a condition of accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product.

Fast track designation, breakthrough therapy designation, priority review, and accelerated approval do not change the standards for approval but may expedite the development or approval process. Even if a product candidate qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

***Post-Approval Requirements***

Any products manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution and advertising and promotion of the product. After approval, most changes to the approved product, such as adding new indications, certain manufacturing changes and additional labeling claims, are subject to further FDA review and approval. Drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP regulations and other laws and regulations. Changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMP regulations and other aspects of regulatory compliance.

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The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events, or AEs, of unanticipated severity or frequency, or with manufacturing processes or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of requirements for post-market trials or clinical trials to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•fines, warning letters or untitled letters;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•clinical holds on ongoing or planned clinical trials;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of approvals;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•product seizure or detention, or refusal to permit the import or export of products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•mandated modification of promotional materials and labeling and the issuance of corrective information;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information about the product; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•injunctions or the imposition of civil or criminal penalties.

In addition, the FDA closely regulates the marketing, labeling, advertising and promotion of drug products. A company can make only those claims relating to safety and efficacy that are approved by the FDA and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians may prescribe legally available products for uses that are not described in the product's labeling and that differ from those tested by us and approved by the FDA. Such off-label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturer's communications on the subject of off-label use of their products.

***Hatch-Waxman Act***

Section 505 of the FDCA describes three types of marketing applications that may be submitted to the FDA to request marketing authorization for a new drug. A Section 505(b)(1) NDA is an application that contains full reports of investigations of safety and efficacy. A 505(b)(2) NDA is an application that contains full reports of investigations of safety and efficacy but where at least some of the information required for approval comes from investigations that were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted. This regulatory pathway enables the applicant to rely, in part, on the FDA's prior findings of safety and efficacy for an existing product, or published literature, in support of its application. Section 505(j) establishes an abbreviated approval process for a generic version of approved drug products through the submission of an Abbreviated New Drug Application, or ANDA. An ANDA provides for marketing of a generic drug product that has the same active ingredients, dosage form, strength, route of administration, labeling, performance characteristics and intended use, among other things, to a previously approved product. ANDAs are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and efficacy. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent to, or performs in the same manner as, the innovator drug through in vitro, in vivo, or other testing. The generic version must deliver the same amount of active ingredients into a subject's bloodstream in the same amount of time as the innovator drug and can often be substituted by pharmacists under prescriptions written for the reference listed drug. In seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent with claims that cover the applicant's drug or a method of using the drug. Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. Drugs listed in the Orange Book can, in turn, be cited by potential competitors in support of approval of an ANDA or 505(b)(2) NDA.

Upon submission of an ANDA or a 505(b)(2) NDA, an applicant must certify to the FDA that (1) no patent information on the drug product that is the subject of the application has been submitted to the FDA; (2) such patent has expired; (3) the date on which

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such patent expires; or (4) such patent is invalid or will not be infringed upon by the manufacture, use or sale of the drug product for which the application is submitted. Generally, the ANDA or 505(b)(2) NDA cannot be approved until all listed patents have expired, except where the ANDA or 505(b)(2) NDA applicant challenges a listed patent through the last type of certification, also known as a paragraph IV certification. If the applicant does not challenge the listed patents or indicates that it is not seeking approval of a patented method of use, the ANDA or 505(b)(2) NDA application will not be approved until all of the listed patents claiming the referenced product have expired. If the ANDA or 505(b)(2) NDA applicant has provided a Paragraph IV certification to the FDA, the applicant must send notice of the Paragraph IV certification to the NDA and patent holders once the application has been accepted for filing by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the Paragraph IV certification. If the Paragraph IV certification is challenged by an NDA holder or the patent owner(s) asserts a patent challenge to the Paragraph IV certification, the FDA may not approve that application until the earlier of 30 months from the receipt of the notice of the Paragraph IV certification, the expiration of the patent, when the infringement case concerning each such patent was favorably decided in the applicant's favor or settled or such shorter or longer period as may be ordered by a court. This prohibition is generally referred to as the 30-month stay. In instances where an ANDA or 505(b)(2) NDA applicant files a Paragraph IV certification, the NDA holder or patent owner(s) regularly take action to trigger the 30-month stay, recognizing that the related patent litigation may take many months or years to resolve. Thus, approval of an ANDA or 505(b)(2) NDA could be delayed for a significant period of time depending on the patent certification the applicant makes and the reference drug sponsor's decision to initiate patent litigation.

***Marketing Exclusivity***

Market exclusivity provisions under the FDCA can delay the submission or the approval of certain marketing applications. The FDCA provides a five-year period of non-patent data exclusivity within the United States to the first applicant to obtain approval of an NDA for a new chemical entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not accept for review an ANDA or 505(b)(2) NDA submitted by another company for another drug based on the same active moiety, regardless of whether the drug is intended for the same indication as the original innovative drug or for another indication, where the applicant does not own or have a legal right of reference to all the data required for approval. However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement to one of the patents listed with the FDA by the innovator NDA holder.

The FDCA alternatively provides three years of non-patent exclusivity for an NDA or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the modification for which the drug received approval on the basis of the new clinical investigations and does not prohibit the FDA from approving ANDAs or 505(b)(2) NDAs for drugs containing the active agent for the original indication or condition of use. Five-year and three-year exclusivity will not delay the submission or approval of a full NDA. However, an applicant submitting a full NDA would be required to conduct, or obtain a right of reference to, all of the preclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.

Pediatric exclusivity is another type of marketing exclusivity available in the United States. Pediatric exclusivity provides for an additional six months of marketing exclusivity attached to another period of existing exclusivity or an available patent term if a sponsor conducts clinical trials in children in response to a "written request" from the FDA. The issuance of a written request does not require the sponsor to undertake the described clinical trials, and the FDA's grant of pediatric exclusivity does not require the FDA to approve labeling containing information on pediatric use based on the studies conducted.

***Other U.S. Healthcare Laws***

Manufacturing, sales, promotion and other activities following product approval are also subject to regulation by numerous regulatory authorities in the United States in addition to the FDA, including but not limited to the Centers for Medicare & Medicaid Services, or CMS, other divisions of the Department of Health and Human Services, or HHS, the Department of Justice, the Drug Enforcement Administration, and state and local governments.

Healthcare providers, including physicians, and third-party payors in the United States and elsewhere play a primary role in the recommendation and prescription of pharmaceutical products. Arrangements with third-party payors and customers can expose pharmaceutical manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act, or FCA, which may constrain the business or financial arrangements and relationships through which companies sell, market and distribute pharmaceutical products. In addition, transparency laws and patient privacy regulations by federal and state governments and by governments in foreign jurisdictions can

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apply to the manufacturing, sales, promotion and other activities of pharmaceutical manufacturers. The applicable federal, state and foreign healthcare laws and regulations that can affect a pharmaceutical company's operations include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under the Medicare and Medicaid programs, or other federal healthcare programs. A person or entity can be found guilty of violating the statute without actual knowledge of the statute or specific intent to violate it. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA. The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary managers on the other. Although there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection. Practices that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor. Failure to meet all of the requirements of an applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the federal Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all relevant facts and circumstances.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The federal civil and criminal false claims laws and civil monetary penalty laws, including the FCA, which prohibit any person or entity from, among other things, knowingly presenting, or causing to be presented, a false, fictitious or fraudulent claim for payment to, or approval by, the federal government or knowingly making, using or causing to be made or used a false record or statement, including providing inaccurate billing or coding information to customers or promoting a product off-label, material to a false or fraudulent claim to the federal government. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes "any request or demand" for money or property presented to the federal government. In addition, manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to "cause" the submission of false or fraudulent claims. The FCA also permits a private individual acting as a "whistleblower" to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The anti-inducement law, which prohibits, among other things, the offering or giving of remuneration, which includes, without limitation, any transfer of items or services for free or for less than fair market value (with limited exceptions), to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary's selection of a particular provider, practitioner or supplier of items or services reimbursable, whole or in part, by a federal or state governmental program;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate it;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose, among other things, specified requirements relating to the privacy, security and transmission of individually identifiable health information held by covered entities, including certain healthcare providers, health plans, and healthcare clearinghouses, as well as their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, and their subcontractors that use, disclose or otherwise process individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys' fees and costs associated with pursuing federal civil actions;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The federal legislation commonly referred to as the Physician Payments Sunshine Act, created under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively the ACA, and its implementing regulations, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children's Health Insurance Program (with certain exceptions) to report annually to CMS, information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professions (such as physicians assistants and nurse

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practitioners), and teaching hospitals, as well as information regarding ownership and investment interests held by physicians and their immediate family members;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Federal government price reporting laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Analogous state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including, but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require drug manufacturers to file reports with states regarding pricing and marketing information, such as the tracking and reporting of gifts, compensations and other remuneration and items of value provided to healthcare professionals and entities; state and local laws requiring certain regulatory licenses to manufacture or distribute products commercially and/or the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

Pricing and rebate programs must comply with the Medicaid rebate requirements of the U.S. Omnibus Budget Reconciliation Act of 1990 and more recent requirements in the ACA. If products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. Products must meet applicable child-resistant packaging requirements under the U.S. Poison Prevention Packaging Act.

The distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products.

Violations of the aforementioned laws can result in civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, possible exclusion from participation in federal and state funded healthcare programs, contractual damages and the curtailment or restricting of our operations, as well as additional reporting obligations and oversight under a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Additionally, private individuals have the ability to bring actions on behalf of the U.S. government under the federal FCA as well as under the false claims laws of several states against a pharmaceutical manufacturer. The approval and commercialization of a pharmaceutical manufacturer's product candidates outside the United States will also likely subject it to foreign equivalents of the healthcare laws mentioned above, among other foreign laws. Lastly, if any of the physicians or other healthcare providers or entities with whom we expect to do business are found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs, which may also adversely affect our business. Any action for violation of these laws, even if successfully defended, could cause a pharmaceutical company to incur significant legal expenses and divert management's attention from the operation of the business.

***U.S. Healthcare Reform*** 

In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs. For example, in March 2010, the ACA was passed, which substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacts the U.S. pharmaceutical industry.

There have been amendments and executive, judicial and congressional challenges to the ACA. For example, on July 4, 2025, the One Big Beautiful Bill Act, or the OBBBA, was signed into law, which narrowed access to ACA marketplace exchange enrollment and declined to extend the ACA enhanced advanced premium tax credits that expired at the end of 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance. The OBBBA also is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program. Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired ACA subsidies.

Other legislative changes have been proposed and adopted in the United States since the ACA was enacted. These changes include aggregate reductions to Medicare payments to providers of 2% per fiscal year, which began in 2013 and will remain in effect until 2032 unless additional Congressional action is taken.

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Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives which could limit the amounts that federal and state governments will pay for healthcare products and services and result in reduced demand for certain pharmaceutical products or additional pricing pressures.

The current administration is pursuing policies to reduce regulations and expenditures across government agencies including at HHS, the FDA, CMS and related agencies. These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business. For example, the current administration has announced agreements with several pharmaceutical companies that require the drug manufacturers to offer, through a direct to consumer platform, U.S. patients and Medicaid programs prescription drug Most-Favored Nation pricing equal to or lower than those paid in other developed nations, with additional mandates for direct-to-patient discounts and repatriation of foreign revenues. Other recent actions, for example, include (1) directing agencies to reduce agency workforce and cut programs; (2) directing HHS and other agencies to lower prescription drug costs through a variety of initiatives; (3) imposing tariffs on imported pharmaceutical products; and (4) as part of the Make America Healthy Again Commission's Strategy Report released in September 2025, working across government agencies to increase enforcement on direct-to-consumer pharmaceutical advertising. Additionally, the current administration recently called on Congress to enact "The Great Healthcare Plan," to codify and expand Most-Favored Nation pricing, lower government subsidies to private insurance companies, increase healthcare price transparency, expand pharmaceutical drugs available for over-the-counter purchase, and enact restrictions on pharmacy benefit manager payment methodologies, among other things. These actions and policies may significantly reduce U.S. drug prices, potentially impacting manufacturers' global pricing strategies and profitability, while increasing their operational costs and compliance risks. In June 2024, the U.S. Supreme Court's Loper Bright decision greatly reduced judicial deference to regulatory agencies, which could increase successful legal challenges to federal regulations affecting our operations. Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program.

At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In addition, regional health care authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other health care programs. These measures could reduce the ultimate demand for our products, once approved, or put pressure on our product pricing.

We expect that additional foreign, federal and state healthcare reform measures will be adopted in the future.

***U.S. Patent-Term Restoration and Marketing Exclusivity*** 

Depending upon the timing, duration and specifics of the FDA approval of our drug candidates, if any, some of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process. However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product's approval date. The patent term restoration period is generally one-half the time between the effective date of an IND and the submission date of an NDA, or the testing phase, plus the time between the submission date of an NDA and the approval of that application, or the approval phase. This patent term restoration period may be reduced by the FDA if it finds that applicant did not act with due diligence during the testing phase or the approval phase. Only one patent applicable to an approved drug is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent. The USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration. In the future, if circumstances permit, we intend to apply for restoration of patent term for one of our then owned or licensed patents, if any, to add patent life beyond its current expiration date, depending on the expected length of the clinical trials and other factors involved in the filing of the relevant NDA. Even if, at the relevant time, we have a valid issued patent covering our product, we may not be granted an extension if we were, for example, to fail to apply within applicable deadlines, to fail to apply prior to expiration of relevant patents or otherwise to fail to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than we request. If we are unable to obtain patent term extension or restoration or the term of any such extension is less than we request, and we do not have any other exclusivity, our competitors may obtain approval of competing products following our patent expiration and our ability to generate revenues could be materially adversely affected.

Some of our products may also be entitled to certain non-patent-related data exclusivity under the FDCA. The FDCA provides a five-year period of non-patent data exclusivity within the U.S. to the first applicant to obtain approval of an NDA for a new chemical entity ("NCE"). A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same

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active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, an abbreviated new drug application ("ANDA"), or a 505(b)(2) NDA may not be submitted by another company for another drug containing the same active moiety, regardless of whether the drug is intended for the same indication as the original innovator drug or for another indication, where the applicant does not own or have a legal right of reference to all the data required for approval. However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement to one of the patents listed with the FDA Orange Book by the innovator NDA holder. The FDCA also provides three years of marketing exclusivity for a full NDA, or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example, for new indications, dosages or strengths of an existing drug. Three-year exclusivity prevents the FDA from approving ANDAs and 505(b)(2) applications that rely on the information that served as the basis of granting three-year exclusivity. This three-year exclusivity covers only the modification for which the drug received approval on the basis of the new clinical investigations, and does not prohibit the FDA from approving ANDAs for drugs containing the active agent for the original indication or condition of use. Five-year and three-year exclusivity will not delay the submission or approval of a full NDA. However, an applicant submitting a full NDA would be required to conduct or obtain a right of reference to all of the non-clinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and efficacy.

Certain additional periods of exclusivity may be available if a product is indicated for use in a rare disease or condition or is studied for pediatric indications. If a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan product exclusivity, which the FDA has interpreted to preclude approving for seven years any other sponsor's application to market the same drug for the same use for which the drug has been granted orphan drug designation, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity. Orphan exclusivity operates independently from other regulatory exclusivities and other protection against generic competition, including patents that we hold for our products. A sponsor of a product application that has received an orphan drug designation may also be granted tax incentives for clinical research undertaken to support the application.

Orphan drug exclusivity does not block approval of competing products intended for the orphan-protected indication but containing a different active moiety, or containing the same moiety but intended for a different use. Orphan product exclusivity that could block a competitor to one of our products also could block the approval of one of our products for seven years if a competitor obtains approval of the product containing the same moiety for the same orphan disease or condition.

Pediatric exclusivity is another type of marketing exclusivity available in the United States. The FDASIA made permanent the Best Pharmaceuticals for Children Act, or BPCA, which extends any existing regulatory exclusivity and patent periods by an additional six months if the sponsor conducts clinical trials in children in response to a Written Request from the FDA. If the Written Request does not include studies in neonates, the FDA is required to include its rationale for not requesting those studies. The FDA may request studies on approved or unapproved indications in separate Written Requests. The issuance of a Written Request does not require the sponsor to undertake the described studies.

***U.S. regulation of companion diagnostics*** 

Our product candidates may require use of an *in vitro* diagnostic to identify appropriate patient populations. These diagnostics, often referred to as companion diagnostics, are regulated as medical devices. In the United States, the FDCA and its implementing regulations, and other federal and state statutes and regulations govern, among other things, medical device design and development, preclinical and clinical testing, premarket clearance or approval, registration and listing, manufacturing, labeling, storage, advertising and promotion, sales and distribution, export and import and post-market surveillance. Unless an exemption applies, companion diagnostic tests require marketing clearance or approval from the FDA prior to commercial distribution. The two primary types of FDA marketing authorization applicable to a medical device are premarket notification, also called 510(k) clearance, and premarket approval, or PMA approval.

If use of companion diagnostic is essential to safe and effective use of a drug or biologic product, then the FDA generally will require approval or clearance of the diagnostic contemporaneously with the approval of the therapeutic product. On August 6, 2014, the FDA issued a final guidance document addressing the development and approval process for "*In Vitro* Companion Diagnostic Devices." According to the guidance, for novel candidates such as our product candidates, a companion diagnostic device and its corresponding drug or biologic candidate should be approved or cleared contemporaneously by FDA for the use indicated in the therapeutic product labeling. The guidance also explains that a companion diagnostic device used to make treatment decisions in clinical trials of a biologic product candidate generally will be considered an investigational device, unless it is employed for an intended use for which the device is already approved or cleared. If used to make critical treatment decisions, such as patient selection, the diagnostic device generally will be considered a significant risk device under the FDA's Investigational Device Exemption, or IDE, regulations. Thus, the sponsor of the diagnostic device will be required to comply with the IDE regulations. According to the guidance, if a diagnostic device and a drug are to be studied together to support their respective approvals, both products can be studied in the same investigational study, if the study meets both the requirements of the IDE regulations and the IND regulations. The

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guidance provides that depending on the details of the study plan and subjects, a sponsor may seek to submit an IND alone, or both an IND and an IDE. In July 2016, the FDA issued a draft guidance document intended to further assist sponsors of therapeutic products and sponsors of *in vitro* companion diagnostic devices on issues related to co-development of these products.

The FDA generally requires companion diagnostics intended to select the patients who will respond to cancer treatment to obtain approval of a PMA for that diagnostic contemporaneously with approval of the therapeutic. The review of these *in vitro* companion diagnostics in conjunction with the review of therapeutic candidates involves coordination of review by the FDA's Center for Biologics Evaluation and Research and by the FDA's Center for Devices and Radiological Health. The PMA process, including the gathering of clinical and preclinical data and the submission to and review by the FDA, can take several years or longer. It involves a rigorous premarket review during which the applicant must prepare and provide the FDA with reasonable assurance of the device's safety and effectiveness and information about the device and its components regarding, among other things, device design, manufacturing and labeling. PMA applications are also subject to an application fee.

PMAs for certain devices must generally include the results from extensive preclinical and adequate and well-controlled clinical trials to establish the safety and effectiveness of the device for each indication for which FDA approval is sought. In particular, for a diagnostic, the applicant must demonstrate that the diagnostic produces reproducible results when the same sample is tested multiple times by multiple users at multiple laboratories. In addition, as part of the PMA review, the FDA will typically inspect the manufacturer's facilities for compliance with the Quality System Regulation, or QSR, which imposes elaborate testing, control, documentation and other quality assurance requirements.

If the FDA evaluations of both the PMA application and the manufacturing facilities are favorable, the FDA will either issue an approval letter or a not-approvable letter, which usually contains a number of conditions that must be met in order to secure the final approval of the PMA, such as changes in labeling, or specific additional information, such as submission of final labeling, in order to secure final approval of the PMA. If the FDA concludes that the applicable criteria have been met, the FDA will issue a PMA for the approved indications, which can be more limited than those originally sought by the applicant. The PMA can include post-approval conditions that the FDA believes necessary to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale and distribution.

If the FDA's evaluation of the PMA or manufacturing facilities is not favorable, the FDA will issue an order denying approval of the PMA or issue a not approvable order. A not approvable letter will outline the deficiencies in the application and, where practical, will identify what is necessary to make the PMA approvable. The FDA may also determine that additional clinical trials are necessary, in which case the PMA approval may be delayed for several months or years while the trials are conducted and then the data submitted in an amendment to the PMA. Once granted, PMA approval may be withdrawn by the FDA if compliance with post approval requirements, conditions of approval or other regulatory standards is not maintained or problems are identified following initial marketing. PMA approval is not guaranteed, and the FDA may ultimately respond to a PMA submission with a not approvable determination based on deficiencies in the application and require additional clinical trial or other data that may be expensive and time-consuming to generate and that can substantially delay approval.

After a device is placed on the market, it remains subject to significant regulatory requirements. Medical devices may be marketed only for the uses and indications for which they are cleared or approved. Device manufacturers must also establish registration and device listings with the FDA. A medical device manufacturer's manufacturing processes and those of its suppliers are required to comply with the applicable portions of the QSR, which cover the methods and documentation of the design, testing, production, processes, controls, quality assurance, labeling, packaging and shipping of medical devices. Domestic facility records and manufacturing processes are subject to periodic unscheduled inspections by the FDA. The FDA also may inspect foreign facilities that export products to the United States.

***European Union Drug Development*** 

In the European Union, or EU, clinical and commercial drug products are subject to extensive regulatory requirements. As in the United States, medicinal products can be marketed only if a marketing authorization from the competent regulatory agencies has been obtained.

Similar to the United States, the various phases of preclinical and clinical research in the European Union are subject to significant regulatory controls. Although the EU Clinical Trials Directive 2001/20/EC has sought to harmonize the EU clinical trials regulatory framework, setting out common rules for the control and authorization of clinical trials in the EU, the EU member states have transposed and applied the provisions of the Directive differently. This has led to significant variations in the member state regimes. Under the current regime, before a clinical trial can be initiated it must be approved in each of the EU countries where the trial is to be conducted by two distinct bodies: the National Competent Authority, or NCA, and one or more Ethics Committees, or

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ECs. Under the current regime all suspected unexpected serious adverse reactions to the investigated drug that occur during the clinical trial have to be reported to the NCA and ECs of the member state where they occurred.

The EU clinical trials legislation currently is undergoing a transition process mainly aimed at harmonizing and streamlining clinical-trial authorization, simplifying adverse-event reporting procedures, improving the supervision of clinical trials and increasing their transparency. Recently enacted Clinical Trials Regulation EU No 536/2014 ensures that the rules for conducting clinical trials in the EU will be identical.

***European Union Drug Review and Approval*** 

In the European Economic Area, or EEA, which is comprised of the 27 member states of the EU and Iceland, Liechtenstein, Norway, medicinal products can only be commercialized after obtaining a Marketing Authorization, or MA. There are two types of marketing authorizations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The Community MA is issued by the European Commission through the Centralized Procedure, based on the opinion of the Committee for Medicinal Products for Human Use, or CHMP, of the EMA and is valid throughout the entire territory of the EEA. The Centralized Procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, advanced-therapy medicines such as gene-therapy, somatic cell-therapy or tissue-engineered medicines and medicinal products containing a new active substance indicated for the treatment of HIV, AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and other immune dysfunctions and viral diseases. The Centralized Procedure is optional for products containing a new active substance not yet authorized in the EEA, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public health in the EU.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•National MAs, which are issued by the competent authorities of the member states of the EEA and only cover their respective territory, are available for products not falling within the mandatory scope of the Centralized Procedure. Where a product has already been authorized for marketing in a member state of the EEA, this National MA can be recognized in other member states through the Mutual Recognition Procedure. If the product has not received a National MA in any member state at the time of application, it can be approved simultaneously in various member state through the Decentralized Procedure. Under the Decentralized Procedure an identical dossier is submitted to the competent authorities of each of the member state in which the MA is sought, one of which is selected by the applicant as the Reference Member State, or RMS. The competent authority of the RMS prepares a draft assessment report, a draft summary of the product characteristics, or SPC, and a draft of the labeling and package leaflet, which are sent to the other member state, referred to as the Member States Concerned, for their approval. If the Member States Concerned raise no objections, based on a potential serious risk to public health, to the assessment, SPC, labeling, or packaging proposed by the RMS, the product is subsequently granted a national MA in all the member states (i.e., in the RMS and the Member States Concerned). Under the above described procedures, before granting the MA, the EMA or the competent authorities of the member states of the EEA make an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.

***European Union Orphan Designation and Exclusivity*** 

In the European Union, the EMA's Committee for Orphan Medicinal Products grants orphan drug designation to promote the development of products that are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than five in 10,000 persons in the European Union community (or where it is unlikely that the development of the medicine would generate sufficient return to justify the investment) and for which no satisfactory method of diagnosis, prevention or treatment has been authorized (or, if a method exists, the product would be a significant benefit to those affected).

In the European Union, orphan drug designation entitles a party to financial incentives such as reduction of fees or fee waivers and ten years of market exclusivity is granted following medicinal product approval. This period may be reduced to six years if the orphan drug designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity. Orphan drug designation must be requested before submitting an application for MA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

***European Union Drug Marketing*** 

Much like the Anti-Kickback Statute prohibition in the United States, the provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is also

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prohibited in the EU. The provision of benefits or advantages to physicians is governed by the national anti-bribery laws of European countries, such as the U.K. Bribery Act 2010. Infringement of these laws could result in substantial fines and imprisonment.

Payments made to physicians in certain EU member states must be publicly disclosed. Moreover, agreements with physicians often must be the subject of prior notification and approval by the physician's employer, his or her competent professional organization as well as the regulatory authorities of the individual EU member states. These requirements are provided in the national laws, industry codes or professional codes of conduct, applicable in the EU member states. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment.

***Data Protection*** 

In the ordinary course of our business, we process personal data (including sensitive health-related data). Accordingly, we are, and may in the future become, subject to numerous data privacy and security obligations, including federal, state, local, and foreign laws, regulations, guidance, and industry standards related to data privacy, security, and protection. Such obligations may include, without limitation, the European Union's General Data Protection Regulation 2016/679 ("EU GDPR") and the EU GDPR as it forms part of United Kingdom ("UK") law by virtue of section 3 of the European Union (Withdrawal) Act 2018 ("UK GDPR"). Several states within the United States have enacted or proposed data privacy laws. Additionally, we are, or may become, subject to various U.S. federal and state consumer protection laws which require us to publish statements that accurately and fairly describe how we handle personal data and choices individuals may have about the way we handle their personal data.

Numerous U.S. states have enacted comprehensive consumer privacy laws that impose certain obligations on covered businesses, including the provision of specific disclosures in privacy notices and affording residents with certain rights concerning their personal data. As applicable, such rights may include the right to access, correct, or delete certain personal data, and to opt-out of certain data processing activities, such as targeted advertising, profiling, and automated decision-making. The exercise of these rights may impact our business. Certain states also impose stricter requirements for processing certain personal data, including sensitive health data, such as conducting data privacy impact assessments. These state laws often allow for the imposition of statutory fines for noncompliance. Outside the United States, under the GDPR, companies may face temporary or definitive bans on data processing and other corrective actions; fines of up to 20 million Euros under the EU GDPR, 17.5 million pounds sterling under the UK GDPR or, in each case, 4% of annual global revenue, whichever is greater; or private litigation related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to represent their interests. See the section titled "We and the third parties with whom we work are subject to rapidly changing and increasingly stringent U.S. and foreign laws, regulations, and rules; contractual obligations; industry standards; policies and other obligations relating to privacy, data protection and information security. Our actual or perceived failure (or that of the third parties with whom we work) to comply with these obligations could lead to regulatory investigations or actions; litigation (including class claims) and mass arbitration demands; fines and penalties; disruptions of business operations; reputational harm; loss of revenue or profits; and other adverse business consequences." for additional information about the laws and regulations to which we may become subject and about the risks to our business associated with such laws and regulations.

***Rest of the World Regulation*** 

For other countries outside of the EU and the United States, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. Additionally, the clinical trials must be conducted in accordance with GCP requirements and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.

If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

***Coverage and Reimbursement*** 

Sales of our products, when and if approved, will depend, in part, on the extent to which our products will be covered by third-party payors, such as government health programs, commercial insurance and managed healthcare organizations. In the United States, no uniform policy of coverage and reimbursement for drug or biological products exists. Accordingly, decisions regarding the extent of coverage and amount of reimbursement to be provided for any of our products will be made on a payor-by-payor basis. As a result, coverage determination is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained. Additionally, we, or our collaborators, will be required to obtain coverage and reimbursement for our companion diagnostic tests separate and apart from the coverage and reimbursement we may seek for our product candidates.

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The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost containment programs to limit the growth of government-paid health care costs, including price-controls, restrictions on reimbursement and requirements for substitution of biosimilars for branded prescription drugs. For example, HHS imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation on an annual basis. HHS has also been empowered to negotiate the price of certain single-source drugs that have been on the market for at least seven (7) years and biologics that have been on the market for at least eleven (11) years covered under Medicare as part of the Medicare Drug Price Negotiation Program. Each year up to twenty (20) products will be selected by HHS for the Medicare Drug Price Negotiation Program. Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis.

As noted above, the marketability of any products for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide coverage and reimbursement. Obtaining coverage and adequate reimbursement for newly approved drugs and biologics is a time-consuming and costly process, and coverage may be more limited than the purposes for which a drug is approved by the FDA or comparable foreign regulatory authorities. Assuming coverage is obtained for a given product by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. Additionally, coverage policies and third-party reimbursement rates may change at any time. Patients who are prescribed medications for the treatment of their conditions, and their prescribing physicians, generally rely on third-party payors to reimburse all or part of the costs associated with their prescription drugs. Patients are unlikely to use products unless coverage is provided and reimbursement is adequate to cover all or a significant portion of the cost of prescribed products.

In addition, in most foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing and reimbursement vary widely from country to country. For example, the EU provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products. Historically, products launched in the European Union do not follow price structures of the United States and generally prices tend to be significantly lower.

**Employees and Human Capital Resources** 

In November 2025, as part of cash preservation measures associated with our previously announced strategic review process, our Board of Directors approved a reduction in force of approximately 65% of our workforce, or the 2025 Restructuring. The 2025 Restructuring was substantially completed during the fourth quarter of 2025. We incurred total charges of approximately $1.7 million in connection with the 2025 Restructuring, consisting primarily of one-time employee termination costs, including severance payments and other employee termination-related expenses, that were contingent upon the impacted employees' execution and non-revocation of separation agreements. Substantially all of the 2025 Restructuring costs were recorded in 2025, with none expected to be recorded in 2026.

As of March 23, 2026, we had 29 full-time employees, including 23 employees who joined in connection with our acquisition of Faeth. We consider our relationship with our employees to be good.

Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants. In connection with the Acquisition, our near-term human capital priorities include the successful integration of former Faeth personnel and the continued development of our organization to support the advancement of our clinical programs, including our planned breast cancer trial. We anticipate selectively expanding our workforce as our clinical and operational needs evolve. The principal purposes of our equity incentive plans are to attract, retain and reward personnel through the granting of stock-based compensation awards in order to increase stockholder value and the success of our Company by motivating such individuals to perform to the best of their abilities and achieve our objectives.

**Corporate Information**

Our common stock is listed on The Nasdaq Capital Market under the symbol "SNSE".

We were originally incorporated as Panacea Pharmaceuticals, Inc., or Panacea, under the laws of the state of Maryland in 1999. In December 2017, we reincorporated in Delaware and changed our name to Sensei Biotherapeutics, Inc. Our principal executive offices are located at 1405 Research Blvd, Rockville, MD 20850. Our telephone number is (240) 243-8000.

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The Faeth design logo, "Faeth", "Faeth Therapeutics," and our other registered or common law trademarks, service marks, or trade names appearing in this Report are the property of Sensei Biotherapeutics, Inc. Other trade names, trademarks and service marks used in this Report are the property of their respective owners. Solely for convenience, trademarks and trade names referred to in this Report exclude the® or TM symbols.

**Available Information**

Our website address is www.senseibio.com. Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to reports filed pursuant to Sections 13(a) and 15(d) of the Exchange Act are made available free of charge on or through our website as soon as reasonably practicable after such reports are filed with, or furnished to, the United States Securities and Exchange Commission, or SEC. The information contained on, or that can be accessed through, our website is not incorporated by reference into this Annual Report on Form 10-K or in any other report or document we file with the SEC, and any references to our website are intended to be inactive textual references only.

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**Item 1A. Risk Factors.** 

*You should carefully consider the risks described below, as well as general economic and business risks and the other information in this Report. The occurrence of any of the events or circumstances described below or other adverse events could have a material adverse effect on our business, results of operations and financial condition and could cause the trading price of our common stock to decline. Additional risks or uncertainties not presently known to us or that we currently deem immaterial may also harm our business.*

**SUMMARY OF RISK FACTORS**

The risk factors summarized below could materially harm our business, operating results, and/or financial condition, impair our future prospects, and/or cause the price of our common stock to decline. These risks are discussed more fully below. Material risks that may affect our business, financial condition, results of operations, and trading price of our common stock include the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•We have a limited operating history, have incurred net losses since our inception, and anticipate that we will incur significant losses for the foreseeable future. We may never generate any revenue or become profitable or, if we achieve profitability, may not be able to sustain it.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•If we are unable to raise additional capital when needed, we may be forced to delay, reduce or eliminate our product development programs or other operations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•We need substantial additional funding to complete the development of our product candidates. A failure to obtain this necessary capital when needed could force us to further delay, limit, reduce or terminate our product development or commercialization efforts.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•We have incurred significant losses in every year since our inception. We expect to continue to incur losses over the next several years and may never achieve or maintain profitability.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Our development efforts are in the early stages. If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Our business is highly dependent on the success of our product candidates that we advance into the clinic. All our product candidates will require significant additional preclinical, clinical and manufacturing development before we may be able to seek regulatory approval for and launch a product commercially. If the clinical trials of any of our product candidates fail to demonstrate safety and efficacy to the satisfaction of the FDA or other comparable regulatory authorities, or do not otherwise produce favorable results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Interim data from our clinical trials that we announce or publish from time to time may change as more patients are enrolled and additional data become available.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•We will depend on timely enrollment of patients in our clinical trials for our product candidates. If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Clinical trials are difficult to design and implement, can be lengthy and expensive, involve uncertain outcomes and may not ultimately be successful.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•We were not involved in the early development of PIKTOR; therefore, we are dependent on third parties having accurately generated, collected, interpreted and reported data from certain preclinical and clinical trials of PIKTOR.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•While emerging clinical data from a competitor has provided evidence supporting the multi-node inhibition concept, there is no guarantee that PIKTOR's specific approach will produce comparable results, and a competitor's first-mover advantage could limit our commercial opportunity.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•We rely, and expect to continue to rely, on third parties to conduct the preclinical and clinical trials for our product candidates, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials or failing to comply with applicable regulatory requirements.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•If we are unable to establish sales, marketing and distribution capabilities for our product candidates, or enter into sales, marketing and distribution agreements with third parties, we may not be successful in commercializing our product candidates, if approved.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•We operate in a rapidly changing industry and face significant competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Even if any of our product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The success of our product candidates will depend on several factors, including obtaining and maintaining patent and trade secret protection and/or regulatory exclusivity for our product candidates.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•If we are unable to obtain and maintain patent protection for our technologies and product candidates, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and product candidates may be impaired.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could significantly harm our business.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•There is no guarantee that the Acquisition will increase stockholder value.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Pursuant to the terms of the Acquisition and related 2026 Private Placement, we are required to recommend that our stockholders approve the conversion of all outstanding shares of our Series B Preferred Stock into shares of our common stock. We must also obtain stockholder approval of an amendment to our certificate of incorporation to increase the number of shares we are authorized to issue. We cannot guarantee that our stockholders will approve these matters, and if they fail to do so we may be required to settle such shares in cash and our operations would be materially harmed.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The failure to successfully integrate the businesses of Sensei and Faeth in the expected timeframe could adversely affect our results of operations, financial condition, and future results.

**Risks Related to Our Financial Position** 

***We have a limited operating history and have incurred significant losses in every year since our inception. We expect to continue to incur losses over the next several years and may never achieve or maintain profitability.*** 

We are a clinical-stage biotechnology company with a limited operating history that may make it difficult to evaluate the success of our business to date and to assess the future viability of our business prospects. Our operations to date have been limited to business planning, including the Acquisition, organizing and staffing our company, raising capital, identifying potential product candidates, conducting clinical trials and preclinical studies for our development programs, entering into licensing agreements, establishing and enhancing our intellectual property portfolio, and providing general and administrative support for these operations.

We have incurred significant net losses since our inception. Our net loss was $21.1 million and $30.2 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $283.1 million. We have funded our operations to date primarily with proceeds from the sale of our equity securities and borrowings of convertible debt.

We have no products approved for commercial sale, have not generated any revenue from commercial sales of our product candidates, and are devoting substantially all of our financial resources and efforts to the research and development of PIKTOR. Investment in clinical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and/or become commercially viable.

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We expect that it will take at least several years until any of our product candidates receive marketing approval and are commercialized, and we may never be successful in obtaining marketing approval and commercializing product candidates. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. These net losses will adversely impact our stockholders' equity and net assets and may fluctuate significantly from quarter to quarter and year to year.

To become and remain profitable, we must succeed in developing and eventually commercializing products that generate significant revenue. Achievement will require us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials of our product candidates, obtaining regulatory approval, manufacturing, marketing and selling any products for which we may obtain regulatory approval, as well as discovering and developing additional product candidates. We may never succeed in these activities and, even if we do, may never generate revenues that are significant enough to achieve profitability.

Because of the numerous risks and uncertainties associated with the development and commercialization of therapeutic product candidates, we are unable to accurately predict the timing or amount of expenses or when, or if, we will be able to achieve and maintain profitability. If we are required by regulatory authorities to perform studies in addition to those currently expected, or if there are any delays in the initiation and completion of our clinical trials or the development of any of our product candidates, our expenses could increase and profitability could be further delayed.

Even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the value of our common stock and could impair our ability to raise capital, expand our business, maintain our research and development efforts or continue our operations. A decline in the value of our common stock could also cause you to lose all or part of your investment.

***Our operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.*** 

As an organization, we have not demonstrated an ability to successfully complete clinical trials, obtain regulatory approvals, manufacture our product candidates at commercial scale or arrange for a third party to do so on our behalf, conduct sales and marketing activities necessary for successful commercialization, or obtain reimbursement in the countries of sale. We may encounter unforeseen expenses, difficulties, complications, and delays in achieving our business objectives. Our operating history makes any assessment of our future success or viability subject to significant uncertainty, particularly with respect to the Acquisition. If we do not address these risks successfully or are unable to transition at some point from a company with a research and development focus to a company capable of supporting commercial activities, then our business will suffer.

***We will need substantial additional funding to complete the development of our product candidates. A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts.*** 

Since our inception, we have used substantial amounts of capital to fund the development of our product candidates and operations. We expect our research and development expenses to increase in connection with our ongoing activities, particularly as our product candidates enter and advance through preclinical studies and clinical trials. We will require substantial additional funding to meet our financial needs and to pursue our business objectives. We will require significant additional capital to, among other things:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•complete our ongoing and planned clinical trials, preclinical studies and IND-enabling activities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•initiate, enroll, and complete additional clinical trials for our product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•seek and obtain regulatory approvals for our product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•build and maintain our manufacturing capabilities or enter into third-party manufacturing arrangements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•expand and protect our intellectual property portfolio; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•fund our general and administrative operations.

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In addition, if we obtain marketing approval for any of our product candidates, we will incur significant commercialization expenses related to marketing, sales, manufacturing and distribution.

Failure to raise capital as and when needed would have a negative impact on our financial condition and ability to develop our product candidates. Furthermore, we cannot be certain that additional funding will be available on acceptable terms. 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, and any of our current or future license agreements may be terminated if we are unable to meet the payment or other obligations under the agreements.

***Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.***

We expect that significant additional capital may be needed in the future to continue our planned operations, including conducting clinical trials, commercialization efforts, research and development activities and costs associated with operating a public company. Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through any or a combination of securities offerings, debt financings, license and collaboration agreements and research grants. If we raise capital through securities offerings, such sales are likely to result in material dilution to our existing stockholders, and new investors could gain rights, preferences and privileges senior to the holders of our common stock.

To the extent that we raise additional capital through the sale of equity, warrants to purchase equity, and/or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder. Debt financing and preferred equity financing, if available, could result in fixed payment obligations, and we may be required to accept terms that restrict our ability to incur additional indebtedness, force us to maintain specified liquidity or other ratios or restrict our ability to pay dividends or make acquisitions.

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. In addition, we could also be required to seek funds through arrangements with collaborators or others at an earlier stage than otherwise would be desirable. If we raise funds through research grants, we may be subject to certain requirements, which may limit our ability to use the funds or require us to share information from our research and development. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to a third party to develop and market product candidates that we would otherwise prefer to develop and market ourselves. Raising additional capital through any of these or other means could adversely affect our business and the holdings or rights of our stockholders, and may cause the market price of our common stock to decline.

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. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquish some rights to our technologies or our product candidates on terms that are not favorable to us. Any additional capital raising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our current and future product candidates, if approved. If we are unable to raise capital when needed or on attractive terms, we could be forced to further delay, reduce or altogether cease our research and development programs or future commercialization efforts.

***Our business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises such as pandemics, political crises, geopolitical events, or other macroeconomic conditions, which have in the past and may in the future negatively impact our business and financial performance.***

The global economy, including credit and financial markets, has experienced extreme volatility and disruptions, including, among other things, severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, supply chain shortages, increases in inflation rates, higher interest rates and uncertainty about economic stability, due to reasons including, among other things, geopolitical conflicts, political changes and trends such as protectionism, economic nationalism resulting in government actions

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impacting international trade agreements or imposing trade restrictions such as tariffs and retaliatory counter measures.

A widespread public health crisis such as a pandemic could result in significant disruption of global financial markets, reducing our ability to access capital, which could negatively affect our liquidity. In addition, a recession or market correction resulting from the effects of public health crises could materially affect our business and the value of our common stock. It may have further negative impacts, such as (a) a global or U.S. recession or other economic crisis; (b) credit and capital markets volatility (and access to these markets, including by our suppliers and customers); (c) manufacturing supply disruption due to travel restrictions or other government actions; (d) disruptions in raw material supply, our manufacturing operations, or in our distribution and supply chain; and (e) our ability to conduct planned clinical trials and commercialization activities. The ultimate impact of a public health crisis is highly uncertain.

Fluctuating interest rates, coupled with reduced government spending and volatility in financial markets, may increase economic uncertainty and affect consumer spending. If the equity and credit markets deteriorate, including as a result of political unrest or war, it may make any necessary debt or equity financing more difficult to obtain in a timely manner or on favorable terms, more costly or more dilutive. Increased inflation rates can adversely affect us by increasing our costs, including labor and employee benefit costs.

**Risks Related to the Development of our Product Candidates** 

***Our development efforts are in the early stages. If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.***

There is no assurance that any clinical trials of our product candidates will be successful or will generate positive clinical data and we may not receive marketing approval from the FDA or other regulatory agencies for any of our product candidates. All our product candidates are in the early stages of our development efforts, and if any of our product candidates encounter safety or efficacy problems, development delays, regulatory issues or other problems, our development plans and forecasted timelines and business could be significantly harmed. While the FDA has not objected to our protocol for PIKTOR in HR+/HER2- breast cancer and we intend to initiate a Phase 1b clinical trial in the first half of 2026, there can be no assurance that the FDA will permit any future IND or protocol for our other product candidates or additional indications to go into effect in a timely manner or at all. We would not be permitted to conduct further clinical trials in the United States without future INDs and approved protocols for our other product candidates.

Biopharmaceutical development is a long, expensive and uncertain process, and delay or failure can occur at any stage of any of our clinical trials. Failure to obtain regulatory approval for our product candidates will prevent us from commercializing and marketing our product candidates. The success in the development of our product candidates will depend on many factors, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•initiating, enrolling, and completing clinical trials;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•submission of INDs for and receipt of allowance to proceed with our clinical trials or other future clinical trials;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•completing preclinical studies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•obtaining positive results from our preclinical studies and clinical trials that support a demonstration of efficacy, safety, and durability of effect for our product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•receiving approvals for commercialization of our product candidates from applicable regulatory authorities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•establishing sales, marketing and distribution capabilities and successfully launching commercial sales of our products, if and when approved, whether alone or in collaboration with others;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•acceptance of our products, if and when approved, by patients, the medical community and third-party payors;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•manufacturing our product candidates at an acceptable cost; and

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•maintaining and growing an organization of scientists, medical professionals and business people who can develop and commercialize our product candidates and technology.

Many of these factors are beyond our control, including the time needed to adequately complete clinical testing and the regulatory submission process. It is possible that none of our product candidates will ever obtain regulatory approval, even if we expend substantial time and resources seeking such approval. If we do not achieve one or more of these factors in a timely manner or at all, or any other factors impacting the successful development of biopharmaceutical products, we could experience significant delays or an inability to successfully develop our product candidates, which could materially harm our business.

***The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.*** 

We do not have any products that have gained regulatory approval. Our business is substantially dependent on our ability to obtain regulatory approval for our preclinical programs. We cannot commercialize product candidates in the United States without first obtaining regulatory approval for the product from the FDA. Before obtaining regulatory approvals for the commercial sale of any product candidate for a particular indication, we must demonstrate with substantial evidence gathered in preclinical and clinical studies that the product candidate is safe and effective for that indication and that the manufacturing facilities, processes and controls are adequate with respect to such product candidate. Prior to seeking approval for any of our product candidates, we will need to confer with the FDA and other regulatory authorities regarding the design of our clinical trials and the type and amount of clinical data necessary to seek and gain approval for our product candidates.

The time required to obtain approval by the FDA and other regulatory authorities is unpredictable and typically takes many years following the commencement of preclinical studies and clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate's clinical development and may vary among jurisdictions. It is possible that none of our existing product candidates or any future product candidates will ever obtain regulatory approval.

Our product candidates could fail to receive regulatory approval from the FDA or other comparable regulatory authorities for many reasons, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•disagreement with the design, protocol or conduct of our clinical trials;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•failure to demonstrate that a product candidate is safe and effective for its proposed indication;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•failure of clinical trials to meet the level of statistical significance required for approval;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•failure to demonstrate that a product candidate's clinical and other benefits outweigh its safety risks;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•disagreement with our interpretation of data from preclinical studies or clinical trials;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•insufficiency of data collected from clinical trials of our product candidates to support the submission and filing of an NDA or other submission or to obtain regulatory approval;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•failure to obtain approval of the manufacturing processes or our facilities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•changes in the approval policies or regulations that render our preclinical and clinical data insufficient for approval; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•lack of adequate funding to complete a clinical trial in a manner that is satisfactory to the applicable regulatory authority.

Many of these risks are beyond our control, including the risks related to clinical development. If we are unable to develop, receive regulatory approval for, or successfully commercialize our product candidates, or if we experience delays as a result of any of these risks or otherwise, our business could be materially harmed.

The FDA or a comparable regulatory authority may require more information, including additional preclinical or clinical data to support approval, including data that would require us to perform additional clinical trials or modify our manufacturing processes, which may delay or prevent approval and our commercialization plans, or we may decide to abandon the development program. If we change our manufacturing processes, we may

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be required to conduct additional clinical trials or other studies, which also could delay or prevent approval of our product candidates. If we were to obtain approval, regulatory authorities may approve any of our product candidates for fewer indications than we request (including failing to approve the most commercially promising indications), may limit indications, may grant approval contingent on the performance of costly post-marketing clinical trials or other post-marketing commitments, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate.

Even if a product candidate were to successfully obtain approval from the FDA or other comparable regulatory authorities in other jurisdictions, any approval might contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, or may be subject to burdensome post-approval study or risk management requirements. If we are unable to obtain regulatory approval for one of our product candidates in one or more jurisdictions, or any approval contains significant limitations, we may not be able to obtain sufficient funding to continue the development of that product candidate or generate revenues attributable to that product candidate. Also, any regulatory approval of our current or future product candidates, once obtained, may be withdrawn.

***Our business is highly dependent on the success of our product candidates that we advance into the clinic, particularly PIKTOR. All of our product candidates, including PIKTOR, will require significant additional preclinical, clinical and manufacturing development before we may be able to seek regulatory approval for and launch a product commercially and we may not be successful in our efforts.*** 

We currently have no products that are approved for commercial sale and may never be able to develop marketable products. We are devoting substantially all our resources to the development of PIKTOR. Our existing clinical data for PIKTOR is derived from a Phase 1b open-label, uncontrolled study with a limited number of evaluable patients. If PIKTOR encounters safety or efficacy problems, development delays, regulatory issues or other problems, our development plans and forecasted timelines and business could be significantly harmed. Because substantially all of our resources are concentrated on a single product candidate, any failure or significant delay in PIKTOR's development would have a disproportionate impact on our business, financial condition and prospects, and we do not have other clinical-stage programs that could offset such a setback.

We cannot provide you with any assurance that we will be able to successfully advance PIKTOR or any additional product candidates through the development process. Our research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical development or commercialization for many reasons, including the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our product candidates may not succeed in preclinical or clinical testing;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•a product candidate may on further study be shown to have harmful side effects, or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•competitors may develop alternatives that render our product candidates obsolete or less attractive;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•product candidates we develop may nevertheless be covered by third parties' patents or other exclusive rights;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the market for a product candidate may change during our development program so that the continued development of that product candidate is no longer reasonable;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•a product candidate may not be accepted as safe and effective by patients, the medical community or third-party payors, if applicable.

If any of these events occur, we may be forced to abandon our development efforts for a program or programs, or we may not be able to identify, discover, develop, or commercialize additional product candidates, which could have a material adverse effect on our business and could potentially cause us to cease operations.

If we do not successfully develop and commercialize product candidates or collaborate with others to do so, we will not be able to obtain product revenue in future periods, which could significantly harm our financial position and adversely affect the trading price of our common stock.

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***While emerging clinical data from third parties has provided evidence supporting the multi-node inhibition concept for the PI3K/AKT/mTOR pathway, there is no guarantee that PIKTOR's specific approach will produce comparable clinical results, and earlier approvals for third party drugs in this class could limit our commercial opportunity.***

Our development strategy for PIKTOR is premised on the hypothesis that simultaneous inhibition of multiple nodes of the PI3K/AKT/mTOR signaling pathway — specifically, concurrent PI3Kα inhibition and mTORC1/2 inhibition — will provide deeper, more durable and more tolerable pathway suppression than currently approved single-node inhibitors. We refer to this approach as multi-node inhibition, or MNI. While recent Phase 3 data for the IV pan-PI3K and mTORC1/2 inhibitor gedatolisib provide clinical evidence supporting the broader MNI concept, there can be no assurance that PIKTOR will produce comparable efficacy or tolerability results in clinical trials.

If gedatolisib receives regulatory approval, it would become the first approved MNI therapy for HR+/HER2- advanced breast cancer and could establish a significant market position before PIKTOR completes clinical development. In that event, PIKTOR would need to demonstrate meaningful differentiation — whether through oral convenience, a favorable tolerability profile, broader patient applicability, or other clinical advantages — in order to compete effectively. There can be no assurance that PIKTOR will be able to demonstrate such differentiation. Furthermore, the PI3K/AKT/mTOR pathway is the subject of intense research, and new modalities or approaches could emerge that are superior to both gedatolisib and PIKTOR, rendering our competitive position obsolete.

In addition, if gedatolisib or another MNI receives regulatory approval and is incorporated into the standard of care for any of our target indications, regulatory authorities may require that future clinical trials of PIKTOR, including any registrational trials, use the newly approved MNI as part of the comparator arm rather than the current standard of care. Such a change could require us to conduct larger, more expensive, and longer clinical trials than currently planned, raise the efficacy threshold that PIKTOR must demonstrate to achieve regulatory approval, and materially increase our development costs and delay our anticipated development timelines. Even if we are able to demonstrate superiority or non-inferiority to a newly approved MNI, the cost, complexity, and duration of the required trials could substantially exceed our current projections, and we may need to raise additional capital to fund such trials. There can be no assurance that we would be able to obtain such additional capital on acceptable terms, or at all.

***If the clinical trials of any of our product candidates fail to demonstrate safety and efficacy to the satisfaction of the FDA or other comparable regulatory authorities, or do not otherwise produce favorable results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.*** 

Before obtaining regulatory approvals for the commercial sale of our product candidates, we must demonstrate through lengthy, complex and expensive preclinical testing and clinical trials that our product candidates are safe, pure and effective for use in each target indication, and failures can occur at any stage of testing. Preclinical studies and clinical trials often fail to demonstrate safety or efficacy of the product candidate studied for the target indication. A failure of one or more clinical trials can occur at any stage of testing. Any side effects or patient deaths could affect the development of our product candidates, even if deemed to not be drug related.

If any such adverse events occur, our clinical trials could be suspended or terminated. If we cannot demonstrate that any adverse events were not caused by the drug, the FDA or foreign regulatory authorities could order us to cease further development of, or deny approval of, our product candidates for any or all targeted indications. Even if we are able to demonstrate that all future serious adverse events are not product-related, such occurrences could affect patient recruitment or the ability of enrolled patients to complete the trial. Moreover, if we elect, or are required, to not initiate, delay, suspend or terminate any future clinical trial of any of our product candidates, the commercial prospects of such product candidates may be harmed and our ability to generate product revenues from any of these product candidates may be delayed or eliminated. Any of these occurrences may harm our ability to develop other product candidates, and may harm our business, financial condition and prospects significantly.

We may experience numerous unforeseen events prior to, during, or as a result of, clinical trials that could delay or prevent our ability to receive marketing approval or commercialize any of our product candidates, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the FDA or other comparable regulatory authority may disagree as to the number, design or implementation of our clinical trials, or may not interpret the results from clinical trials as we do;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•we may not reach agreement on acceptable terms with prospective clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different clinical trial sites;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•clinical trials of our product candidates may produce negative or inconclusive results;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•we may decide, or regulators may require us, to conduct additional preclinical studies or clinical trials or abandon our product development programs;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate, participants may drop out of these clinical trials at a higher rate than we anticipate or we may fail to recruit suitable patients to participate in a trial;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•regulators may issue a clinical hold, or regulators or institutional review boards may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the cost of clinical trials of our product candidates may be greater than we anticipate;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the FDA or other comparable regulatory authorities may fail to approve our manufacturing processes or facilities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or institutional review boards to suspend or terminate the clinical trials; and

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

To the extent that the results of the trials are not satisfactory for the FDA or regulatory authorities in other countries or jurisdictions to approve our NDAs or other comparable applications, the commercialization of our product candidates may be significantly delayed, or we may be required to expend significant additional resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates.

***Clinical trials are difficult to design and implement, can be lengthy and expensive, involve uncertain outcomes and may not ultimately be successful.*** 

It is impossible to predict when or if any of our current or future product candidates will prove effective and safe in humans or will receive regulatory approval. Before obtaining marketing approval from regulatory authorities for the sale of any product candidate, we must complete preclinical studies and then conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Human clinical trials are expensive, can take many years to complete, and are difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The design of a clinical trial can determine whether its results will support approval of a product and flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced. As an organization, we have limited experience designing clinical trials and may be unable to design and execute a clinical trial to support regulatory approval. There is a high failure rate for oncology product candidates proceeding through clinical trials. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results in preclinical testing and earlier-stage clinical trials. Data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory approval. In addition, we may experience regulatory delays or rejections as a result of many factors, including changes in regulatory policy during the period of our

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product candidate development. Any such delays could negatively impact our business, financial condition, results of operations and prospects.

In addition, our ongoing Phase 2 trial in advanced endometrial cancer, Study FTH-PIK-201, includes an optional sub-study in which enrolled patients may combine an insulin-suppressing diet with their PIKTOR plus paclitaxel treatment regimen. Because participation in the diet sub-study is optional, patients who elect to participate may differ in meaningful ways from those who do not, and the resulting patient subgroups may not be balanced with respect to baseline characteristics or other factors that could influence clinical outcomes. If a significant proportion of patients participate in the diet sub-study, or if the diet has any effect — whether positive or negative — on efficacy or tolerability endpoints, it may be difficult to attribute observed clinical outcomes solely to PIKTOR. This could complicate our ability to interpret the trial's results, could raise questions from regulatory authorities, and could reduce the evidentiary value of the trial for purposes of supporting future regulatory submissions or clinical development decisions.

***Negative outcomes or data integrity failures by competitors in the oncology space could adversely affect our business, reputation, and the regulatory and commercial environment in which we operate.***

The clinical and commercial success of PIKTOR may be influenced not only by our own data and results, but also by the outcomes and perceived integrity of data generated by competitors operating in the same therapeutic area, including other multi-node inhibitors. If a competitor's product or product candidate is withdrawn from the market, subject to a safety recall, or associated with serious adverse events, whether in clinical trials or following regulatory approval, patients, physicians, payers, and the broader medical community may develop a generalized skepticism or loss of confidence in the underlying treatment modality or target mechanism. This loss of confidence could reduce patient enrollment in our clinical trials, dampen physician adoption of our products, or cause payers to impose more restrictive coverage and reimbursement policies, regardless of whether our products share the specific deficiencies identified in the competitor's product.

We have no control over the research, development, manufacturing, or commercial practices of our competitors in the oncology space, and we cannot predict whether their data or products will meet the standards expected by regulators, the medical community, or the public. Any of the foregoing events could have a material adverse effect on our business, financial condition, results of operations, and prospects.

***We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or have a greater likelihood of success.*** 

Because we have limited financial and management resources, we focus on research programs and product candidates that we identify for specific indications. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential. For example, we are currently focusing the majority of our efforts on the development of PIKTOR. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate. Our spending on current and future research and development programs and product candidates for specific indications may not yield any commercially viable products.

***Success in preclinical studies or clinical trials may not be predictive of results in future clinical trials.*** 

Results from preclinical studies and early clinical trials may not be predictive of the success of later clinical trials, and interim results of clinical trials are not necessarily predictive of final results. We do not know whether our candidates will be effective for the intended indications or safe in humans. Our product candidates may fail to show the desired safety and efficacy in preclinical or clinical development despite positive results observed in early preclinical studies or having successfully advanced through initial clinical trials. Any failure to establish sufficient efficacy and safety could cause us to abandon clinical development of our product candidates. Further, our clinical trials to date have involved small patient populations. Because of the small sample sizes, the results of these trials may not be indicative of results of future clinical trials.

***We were not involved in the early development of PIKTOR; therefore, we are dependent on third parties having accurately generated, collected, interpreted and reported data from certain preclinical and clinical trials of PIKTOR.***

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We had no involvement with or control over the initial preclinical and clinical development of PIKTOR. We are dependent on third parties having conducted their research and development in accordance with the applicable protocols and legal, regulatory and scientific standards; having accurately reported the results of all preclinical studies and clinical trials conducted with respect to such drug product; and having correctly collected and interpreted the data from these trials. If these activities were not compliant, accurate or correct, the clinical development, regulatory approval or commercialization of PIKTOR will be delayed and may be adversely affected.

***Interim topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patients are enrolled and additional data become available, and are subject to audit and verification procedures that could result in material changes in the final data.*** 

We expect to publish from time to time interim topline or preliminary data from our clinical trials. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the topline or preliminary results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Preliminary or topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. From time to time, we may also disclose interim data from our clinical trials. Interim data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available or as patients from our clinical trials continue other treatments for their disease. Adverse differences between preliminary or interim data and final data could significantly harm our reputation and business prospects. Further, disclosure of interim data by us or by our competitors could result in volatility in the price of our common stock.

Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the potential of the particular program, the likelihood of marketing approval or commercialization of the particular product candidate, any approved product, and our company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is derived from information that is typically extensive, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure.

If the interim, topline, or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.

***The cross-trial comparisons we present regarding PIKTOR's safety and efficacy profile relative to other PI3K/AKT/mTOR pathway agents are subject to significant limitations and may not be predictive of PIKTOR's relative performance in future controlled studies.***

In this Report and in our other public communications, we present data comparing PIKTOR's emerging clinical profile, including rates of hyperglycemia and stomatitis, pharmacokinetic and pharmacodynamic characteristics, and preclinical potency, to published data from clinical trials of approved single-node inhibitors and other multi-node inhibitors in development. These comparisons are derived from different clinical trials conducted at different times, with differences in trial design, patient populations, disease settings, dosing regimens, endpoints, sample sizes, follow-up periods, and adverse event grading criteria. No head-to-head clinical trials have been conducted comparing PIKTOR to any of the agents referenced in these comparisons, and cross-trial comparisons are inherently limited and may not accurately reflect the relative safety or efficacy of the agents being compared.

Physicians, patients, investors, and regulatory authorities may draw conclusions from these cross-trial comparisons that are not supported by the underlying data, or may discount PIKTOR's potential based on the inherent limitations of such comparisons. If PIKTOR's clinical profile does not compare as favorably to competing agents in head-to-head or registrational trials as our cross-trial analyses suggest, the commercial prospects and perceived differentiation of PIKTOR could be materially diminished.

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***We depend on timely enrollment of patients in our clinical trials for our product candidates. If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.*** 

Identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion. The enrollment of patients depends on many factors, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the patient eligibility criteria defined in the protocol;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the number of patients with the disease or condition being studied;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the perceived risks and benefits of the product candidate in the trial, including with respect to PIKTOR, perceived risks related to results of prior trials of serabelisib and sapanisertib alone or in combination;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•clinicians' and patients' perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating or drugs that may be used off-label for these indications;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•clinicians' and patients' perceptions as to any risks associated with our competitors' product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the size and nature of the patient population required for analysis of the trial's primary endpoints;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the proximity of patients to study sites;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the design of the clinical trial;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our ability to recruit clinical trial investigators with the appropriate competencies and experience;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•competing clinical trials for similar therapies or other new therapeutics;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our ability to obtain and maintain patient consents;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the risk that patients enrolled in clinical trials will drop out of the clinical trials before completion of their treatment; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•factors we may not be able to control, such as pandemics, that may limit patients, principal investigators or staff or clinical site available.

In addition, because the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which could further reduce the number of patients who are available for our clinical trials in these clinical trial sites.

Delays in patient enrollment may result in increased costs or may affect the timing or outcome of the clinical trials, which could prevent completion of these clinical trials and adversely affect our ability to advance the development of our product candidates. In addition, many of the factors that may lead to a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

***The market opportunities for certain of our product candidates may be limited to those patients who are ineligible for or have failed prior treatments and, therefore, may be small, and our projections regarding the size of the addressable market may be incorrect.*** 

Our approach is based on multi-node inhibition of the PI3K/AKT/mTOR pathway. While emerging Phase 3 data from a competitor have provided clinical evidence supporting this broader concept, our specific product candidate, PIKTOR, has not been evaluated in registrational clinical trials, which makes it difficult for us to predict the time and cost of product development and potential for regulatory approval. Cancer therapies are sometimes characterized as first line, second line or third line, and the FDA often approves new therapies initially only for third line use. When cancers are detected they are treated with first line of therapy with the intention of curing the cancer.

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This treatment generally consists of chemotherapy, radiation, antibody drugs, tumor targeted small molecules, or a combination of these. If the patient's cancer relapses, then the patient is given a second line or third line therapy, which can consist of more chemotherapy, radiation, antibody drugs, tumor targeted small molecules, or a combination of these. Generally, the higher the line of therapy, the lower the chance of a cure. With third or higher line, the goal of the therapy is to control the growth of the tumor and extend the life of the patient, as a cure is unlikely to happen. Patients are generally referred to clinical trials in these situations.

There is no guarantee that any of our product candidates, even if approved, would be approved for an early line of therapy. In addition, we may have to conduct additional large randomized clinical trials prior to gaining approval for the earlier line of therapy.

Our projections of both the number of people who have the cancers we are targeting, as well as the size of the patient population subset of people with these cancers in a position to receive first, second, third and fourth line therapy and who have the potential to benefit from treatment with our product candidates, are based on our beliefs and estimates. These estimates have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations, or market research and may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these cancers. The number of patients may turn out to be fewer than expected. Additionally, the potentially addressable patient population for our product candidates may be limited or may not be amenable to treatment with our product candidates. Even if we obtain significant market share for our product candidates, because the potential target populations are small, we may never achieve significant revenues without obtaining regulatory approval for additional indications or as part of earlier lines of therapy.

***Our projections of addressable market opportunity for PIKTOR are based on estimates and assumptions that may prove incorrect, and the actual commercial opportunity may be substantially smaller than we expect.***

We have made internal estimates of the total addressable market for PIKTOR and other product candidates targeting the PI3K/AKT/mTOR pathway, including estimates of patient populations, treatment penetration rates, and potential pricing. These estimates are based on a variety of sources, including published scientific literature, epidemiological data, market research and our own assumptions about competitive dynamics. However, these estimates are inherently uncertain and may prove to be materially incorrect.

The actual addressable market for PIKTOR may be smaller than we estimate for several reasons, including: the number of patients with actionable alterations in the PI3K/AKT/mTOR pathway may be lower than projected; physicians may not adopt PIKTOR over established therapies; payors may restrict reimbursement; PIKTOR may initially be approved only for later-line treatment settings with smaller patient populations; competing products may capture significant market share before PIKTOR reaches the market; and advances in precision oncology may further segment the patient population. If the actual market opportunity for PIKTOR is materially smaller than our estimates, we may not be able to generate sufficient revenue to justify our development investment, which could have a material adverse effect on our business and financial condition.

In particular, our estimates of PIKTOR's addressable market include an assumption that multi-node inhibition may confer clinical benefit to patients whose tumors are activated through the PI3K/AKT/mTOR pathway in its non-mutated, or "wild-type," state, either through dysregulated upstream signaling or as an adaptive response to prior therapy. This belief is based on limited clinical data from a small number of patients in an open-label, uncontrolled Phase 1b study in which responses were observed across multiple mutational classifications, including in patients with no detectable pathway mutations, and on our interpretation of PIKTOR's mechanism of action. These observations have not been confirmed in larger or controlled clinical trials and may not be replicated in our ongoing or planned studies. If multi-node inhibition does not demonstrate meaningful clinical benefit in patients without direct PI3K/AKT/mTOR pathway alterations, the addressable patient population for PIKTOR could be significantly smaller than we currently estimate, which would reduce our anticipated commercial opportunity and could have a material adverse effect on our business, financial condition, and prospects.

***Adverse side effects or other safety risks associated with our product candidates could delay or preclude approval, cause us to suspend or discontinue clinical trials, cause us to abandon product candidates, could limit the commercial profile of an approved label, or could result in significant negative consequences following any potential marketing approval.*** 

Our clinical trials will include cancer patients who are very sick and whose health is deteriorating. It is possible that some of these patients may experience side effects during our clinical trials. For example, in a prior clinical trial of PIKTOR, it was reported that one patient had Grade 3 septic shock that was determined to be

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drug-related. In addition, PI3K and mTOR inhibitors as a class are associated with known adverse effects including hyperglycemia, stomatitis, diarrhea, rash and hepatotoxicity. These class-effect toxicities have been observed with approved drugs targeting this pathway and may also be associated with PIKTOR. If these or other adverse effects occur with unacceptable frequency or severity in our clinical trials, our ability to develop and commercialize PIKTOR could be materially impaired. Further, patients may die during our clinical trials for various reasons. The causes of death could include receiving our product candidates because the patient's disease is too advanced or because the patient experiences medical problems that may not be related to our product candidate. Even if the patient deaths are not related to our product candidate, the deaths could affect perceptions regarding the safety of our product candidates. Patient deaths and severe side effects caused by our product candidates, or by products or product candidates of other companies that are thought to have similarities with our product candidates, could result in the delay, suspension, clinical hold or termination of our clinical trials, the FDA or other regulatory authorities for a number of reasons. If we elect or are required to delay, suspend or terminate any clinical trial of any product candidates that we develop, the commercial prospects of such product candidates will be harmed and our ability to generate product revenues from any of these product candidates would be delayed or eliminated. Serious adverse events observed in clinical trials could hinder or prevent market acceptance of the product candidate at issue. Any of these occurrences may harm our business, prospects, financial condition and results of operations significantly.

Additionally, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, including during any long-term follow-up observation period recommended or required for patients who receive treatment using our products, a number of potentially significant negative consequences could result, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•regulatory authorities may withdraw or limit their approval of such products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•regulatory authorities may require the addition of labeling statements, such as a "boxed" warning or a contraindication;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•we may be required to create a Risk Evaluation and Mitigation Strategy, or REMS, plan, which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for healthcare providers, and/or other elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•we may decide to remove such products from the marketplace;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•we could be sued and held liable for harm caused to patients; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our reputation may suffer.

Any of the foregoing could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm our business, results of operations, and prospects.

***Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming and uncertain and may prevent us or any future collaboration partners from obtaining approvals for the commercialization of any other product candidate we develop.*** 

Any product candidate we may develop and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, and distribution, are subject to comprehensive regulation by the FDA and other regulatory authorities in the United States and by comparable authorities in other countries. Failure to obtain marketing approval for a product candidate will prevent us from commercializing the product candidate in a given jurisdiction. We have not received approval to market any product candidates from regulatory authorities in any jurisdiction and it is possible that none of the product candidates we may seek to develop in the future will ever obtain regulatory approval. We have no experience in filing and supporting the applications necessary to gain marketing approvals and expect to rely on third-party contract research organizations, or CROs, or regulatory consultants to assist us in this process. Securing regulatory approval requires the submission of extensive preclinical and clinical data and supporting information to the various regulatory authorities for each therapeutic indication to establish the product candidate's safety and efficacy. Securing regulatory approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authority. Any product candidates we develop may not be effective, may be only moderately effective, or

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may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use.

The process of obtaining marketing approvals, both in the United States and abroad, is expensive, may take many years if additional clinical trials are required, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity, and novelty of the product candidates involved. Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application. The FDA and comparable authorities in other countries have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit, or prevent marketing approval of a product candidate. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

If we experience delays in obtaining approval or if we fail to obtain approval of any product candidates we may develop, the commercial prospects for those product candidates may be harmed, and our ability to generate revenues may be materially impaired.

**Risks Related to Manufacturing and our Dependence on Third Parties** 

***We currently rely, and expect to continue to rely, on third parties to conduct, supervise, and monitor our preclinical studies and clinical trials. If those third parties do not perform satisfactorily, including failing to meet deadlines for the completion of such clinical trials or failing to comply with regulatory requirements, we may be unable to obtain regulatory approval for our product candidates.***

We currently rely on third-party CROs, academic institutions, study sites, clinical investigators and others to conduct, supervise, and monitor our preclinical studies and clinical trials. We expect to continue to rely on third parties, such as CROs, clinical data management organizations, medical institutions, and clinical investigators, to conduct our preclinical studies and clinical trials. Although we currently have or plan to enter into agreements governing the activities of these third parties, we have limited influence over their actual performance and control only certain aspects of their activities. The failure of these third parties to successfully carry out their contractual duties or meet expected deadlines could substantially harm our business because we may be delayed in completing or unable to complete the studies required to develop PIKTOR and other current and future product candidates, or we may not obtain marketing approval for, or commercialize, PIKTOR or our other current and future product candidates in a timely manner or at all.

Moreover, these agreements might terminate for a variety of reasons, including a failure to perform by the third parties. If we need to enter into alternative arrangements our product development activities could be delayed and our business, financial condition, results of operations, stock price and prospects may be materially harmed.

Our reliance on these third parties for development activities reduces our control over these activities. Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards and our reliance on third parties does not relieve us of our regulatory responsibilities. For example, we will remain responsible for ensuring that each of our trials is conducted in accordance with the general investigational plan and protocols for the trial. We must also ensure that our preclinical studies are conducted in accordance with the FDA's Good Laboratory Practice, or GLP, regulations, as appropriate. Moreover, the FDA and comparable foreign regulatory authorities require us to comply with GCPs for conducting, recording, and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial participants are protected. Regulatory authorities enforce these requirements through periodic inspections of trial sponsors, clinical investigators, and trial sites. If we or any of our third parties fail to comply with applicable GCPs or other regulatory requirements, we or they may be subject to enforcement or other legal actions, the data generated in our trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional studies.

In addition, we will be required to report certain financial interests of our third-party investigators if these relationships exceed certain financial thresholds or meet other criteria. The FDA or comparable foreign regulatory authorities may question the integrity of the data from those clinical trials conducted by investigators who may have conflicts of interest.

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We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with the applicable regulatory requirements. In addition, our clinical trials must be conducted with product candidates that were produced under cGMP regulations. Failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process. We also are required to register certain clinical trials and post the results of certain completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within specified timeframes. Failure to do so can result in enforcement actions and adverse publicity.

The third parties with which we work may also have relationships with other entities, some of which may be our competitors, for whom they may also be conducting trials or other therapeutic development activities that could harm our competitive position. In addition, such third parties are not our employees, and except for remedies available to us under our agreements with such third parties we cannot control whether or not they devote sufficient time and resources to the development of our product candidates. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our preclinical studies or clinical trials in accordance with regulatory requirements or our stated protocols, if these parties are adversely impacted by a pandemic limiting or materially affecting their ability to carry out their contractual duties, if they need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our protocols, regulatory requirements or for other reasons, our trials may be repeated, extended, delayed, or terminated; we may not be able to obtain, or may be delayed in obtaining, marketing approvals for current and future product candidates; we may not be able to, or may be delayed in our efforts to, successfully commercialize current and future product candidates; or we or they may be subject to regulatory enforcement actions. As a result, our results of operations and the commercial prospects for current and future product candidates may be harmed, our costs could increase and our ability to generate revenues could be delayed. To the extent we are unable to successfully identify and manage the performance of third-party service providers in the future, our business, financial condition, results of operations, stock price and prospects may be materially harmed.

We may enter into collaborations for our current or future product candidates or technologies. We cannot control the timing or quantity of resources that our existing or future collaborators will dedicate to research, preclinical and clinical development. Our collaborators may not perform their obligations according to our expectations or standards of quality. Our collaborators could terminate our existing agreements for a number of reasons.

We will also rely on other third parties to store and distribute our product candidates for the clinical trials that we plan to conduct. Any performance failure on the part of our distributors could delay clinical development, marketing approval, or commercialization of current and future product candidates, which could result in additional losses and deprive us of potential product revenue.

If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative providers or to do so on commercially reasonable terms. Switching or adding additional third parties involves additional cost and requires management's time and focus. In addition, there is a natural transition period when a new third party commences work. As a result, delays could occur, which could compromise our ability to meet our desired development timelines.

***Certain of our current and future product candidates will be evaluated in combination with third-party drugs, and we will have limited or no control over the supply, regulatory status, or regulatory approval of such drugs.***

Our ability to develop and ultimately commercialize current and future product candidates used in combination with other compounds will depend on our ability to access such drugs on commercially reasonable terms for clinical trials and their availability for use with the commercialized product, if approved. Any failure to enter into successful commercial relationships, or inability to source or purchase other potential combination agents in the market, may delay our development timelines, increase our costs and jeopardize our ability to develop current and future product candidates as potential combination therapies, which may materially harm our business, financial condition, results of operations, stock price and prospects. Moreover, the development of product candidates for use in combination with another product or product candidate may present challenges that are not encountered when developing single-agent product candidates. For example, the FDA may require us to use more complex clinical trial designs in order to evaluate the contribution of each product and product candidate to any observed effects. Additionally, following product approval, the FDA may require that products used in conjunction with each other be cross labeled for combined use. To the extent that we do not have rights to the other product, this may require us to work with a third party under terms unfavorable to us to satisfy such a requirement. Moreover, developments related

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to the other product may impact our clinical trials for the combination as well as our commercial prospects should we receive marketing approval. Such developments may include changes to the other product's safety or efficacy profile, changes to the availability of the approved product, and changes to the standard of care.

***We currently rely on CMOs for the production of PIKTOR and we expect to rely on CMOs for our other product candidates. This reliance on CMOs increases the risk that we will not have sufficient quantities of such materials, product candidates, or any therapies that we may develop and commercialize, or that such supply will not be available to us at an acceptable cost, which could delay, prevent, or impair our development or commercialization efforts.***

Because PIKTOR is a combination of two active pharmaceutical ingredients, our manufacturing and supply chain for PIKTOR requires coordination across two separate drug substances, and any disruption to the supply of either component could halt our entire development program. The need to maintain parallel supply chains for two drug substances increases our operational complexity and our vulnerability to supply disruptions compared to single-agent product candidates. We may not be able to secure backup suppliers for both components on commercially reasonable terms. Any significant delay in the supply of either serabelisib or sapanisertib could considerably delay our clinical development, increase our costs, and have a material adverse effect on our business.

We currently have no plans to build our own clinical or commercial scale manufacturing capabilities for our product candidates. Instead, we expect to rely on third parties for the manufacture of our product candidates and related raw materials for future preclinical and clinical development, as well as for commercial manufacture if any of our product candidates receive marketing approval. We have entered into arrangements with a limited number of third-party contract manufacturing organizations, or CMOs, as part of our development of our product candidates. These CMOs will provide drug substance intermediate and drug product that will be subsequently labeled, packaged and distributed to our CROs. We may also enter into agreements with additional companies for the supply of substances for use in the development of our product candidates or any future product candidates or for the manufacture of such product candidates.

We or our third-party suppliers or manufacturers may encounter shortages in the raw materials or active pharmaceutical ingredient, or API, necessary to produce product candidates we may develop in the quantities needed for our clinical trials or, if any current or future product candidates we may develop are approved, in sufficient quantities for commercialization or to meet an increase in demand, as a result of capacity constraints or delays or disruptions in the market for the raw materials or API, including shortages caused by the purchase of such raw materials or API by our competitors or others. Even if raw materials or API are available, we may be unable to obtain sufficient quantities at an acceptable cost or quality. The need to synchronize the procurement of two APIs for our fixed combination drug product candidate PIKTOR presents additional risk since any imbalance in availability and timing of one API would prevent the manufacture of finished drug product for clinical trials or commercial use. The failure by us or our third-party suppliers or manufacturers to obtain the raw materials or API necessary to manufacture sufficient quantities of any current or future product candidates we may develop could delay, prevent or impair our development efforts and may have a material adverse effect on our business.

The facilities used by third-party manufacturers to manufacture current or future product candidates must be authorized by the FDA pursuant to inspections that will be conducted after we submit a NDA to the FDA. We do not control the manufacturing process of, and are completely dependent on, third-party manufacturers for compliance with cGMP requirements for manufacture of drug products and other laws and regulations. If these third-party manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others, they will not be able to secure and maintain regulatory approval for their manufacturing facilities. In addition, we have no control over the ability of third-party manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which could significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved.

Finding new CMOs or third-party suppliers involves additional cost and requires our management's time and focus. In addition, there is typically a transition period when a new CMO commences work. Although we do not intend to begin a clinical trial unless we believe we have on hand, or will be able to obtain, a sufficient supply of our product candidates to complete the clinical trial, any significant delay in the supply of our product candidates or the raw materials needed to produce our product candidates, could considerably delay conducting our clinical trials and potential regulatory approval of any of our product candidates. Additionally, any changes implemented by a new

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CMO could delay completion of clinical trials, require the conduct of bridging clinical trials or studies, require the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our current and future product candidates and jeopardize our ability to commence product sales and generate revenue.

If any CMO with whom we contract fails to perform its obligations, we may be forced to manufacture the materials ourselves, for which we may not have the capabilities or resources, or enter into an agreement with a different CMO, which we may not be able to do on reasonable terms, if at all. In either scenario, our clinical trials or commercial supply could be delayed significantly as we establish alternative supply sources. In some cases, the technical skills required to manufacture our products or product candidates may be unique or proprietary to the original CMO and we may have difficulty, or there may be contractual restrictions prohibiting us from, transferring such skills to a back-up or alternate supplier, or we may be unable to transfer such skills at all. In addition, if we are required to change CMOs for any reason, we will be required to verify that the new CMO maintains facilities and procedures that comply with quality standards and with all applicable regulations. We will also need to verify, such as through a manufacturing comparability study, that any new manufacturing process will produce our product candidate according to the specifications previously submitted to or approved by the FDA or another regulatory authority. The delays associated with the verification of a new CMO could negatively affect our ability to develop product candidates or commercialize our products in a timely manner or within budget. Furthermore, a CMO may possess technology related to the manufacture of our product candidates that such CMO owns independently. This would increase our reliance on such CMO or require us to obtain a license from such CMO in order to have another CMO manufacture our product candidates or products. In addition, in the case of CMOs that supply our product candidates, changes in manufacturers often involve changes in manufacturing procedures and processes, which could require that we conduct bridging studies between our prior clinical supply used in our clinical trials and that of any new manufacturer. We may be unsuccessful in demonstrating the comparability of clinical supplies which could require the conduct of additional clinical trials.

As part of their manufacture of our product candidates, our CMO and third-party suppliers are expected to comply with and respect the intellectual property and proprietary rights of others. If our CMO or third-party supplier fails to acquire the proper licenses or otherwise infringes, misappropriates or otherwise violates the intellectual property or proprietary rights of others in the course of providing services to us, we may have to find alternative CMOs or third-party suppliers or defend against applicable claims, either of which could significantly impact our ability to develop, obtain regulatory approval for or commercialize our product candidates, if approved.

Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, seizures or recalls of product candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products. In addition, we may be unable to establish any agreements with third-party manufacturers or to do so on acceptable terms.

Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•failure of third-party manufacturers to comply with regulatory requirements and maintain quality assurance;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•breach of the manufacturing agreement by the third party;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•failure to manufacture our product according to our specifications;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•failure to manufacture our product according to our schedule or at all;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•production difficulties caused by unforeseen events that may delay the availability of one or more of the necessary raw materials or delay the manufacture of any current or future product candidates for use in clinical trials or for commercial supply;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•misappropriation of our proprietary information, including our trade secrets and know-how; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

Any product candidates that we may develop may compete with other product candidates and products for access to manufacturing facilities. Any performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval, and any related remedial measures may be costly or

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time-consuming to implement. We do not currently have arrangements in place for redundant supply or second sources of supply with alternative suppliers or CMOs to supplement or supply the raw materials, drug substances, intermediates, and drug product necessary for the manufacture of our product candidates, including PIKTOR. If our current third-party CMO cannot perform as agreed, we may be required to replace such manufacturer and we may be unable to replace them on a timely basis or at all.

***Because we rely on a limited number of suppliers for the raw materials used in our drug candidates, any delay, shortage or interruption in the supply of such raw materials or contamination in our manufacturing process could lead to delays in the manufacture and supply of our drug candidates.***

We rely on third-parties to supply certain raw materials necessary to produce our drug candidates for preclinical studies and clinical trials. For example, we rely on third-parties to supply certain reagents, which are substances used in our manufacturing processes to bring about chemical or biological reactions, and other specialty materials and equipment, some of which are manufactured or supplied by small companies with limited resources. There are a small number of suppliers for certain raw materials that we use to manufacture our drug candidates. Certain of our suppliers or their sub-suppliers are based in China, which exposes us to additional risks including trade restrictions, tariffs, export controls, geopolitical tensions, and potential disruptions to the supply chain that are beyond our control. We work with our CMOs to purchase these materials from our suppliers who may not always have long-term supply agreements in place, which could expose us to a variety of risks, including a potential inability to obtain critical materials and reduced control over production costs, delivery schedules, reliability and quality. Any unanticipated disruption to our contract manufacturing caused by problems at suppliers could delay shipment of our product candidates, increase our cost of goods sold and result in lost sales with respect to any approved products. Any significant delay in the supply of raw materials for our drug candidates for a preclinical study or a clinical trial due to the need to replace a third-party supplier could considerably delay completion of certain preclinical studies and/or clinical trials. Moreover, if we are unable to purchase sufficient raw materials after regulatory approval for our drug candidates, the commercial launch of our drug candidates could be delayed, or there could be a supply shortage, each of which could impair our ability to generate revenues from their sale.

In addition, a material shortage, contamination, recall or restriction on the use of substances in the manufacture of our drug candidates, or the failure of any of our key suppliers to deliver necessary components required for the manufacture of our drug candidates, could adversely impact or disrupt the commercial manufacture or the production of clinical material, which could materially and adversely affect our development timelines and our business, financial condition, results of operations, and future prospects.

***Our employees, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.*** 

We are exposed to the risk that our employees, principal investigators, CROs and consultants may engage in fraudulent conduct or other illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violate the regulations of the FDA and other regulatory authorities, including those laws requiring the reporting of true, complete and accurate information to such authorities; healthcare fraud and abuse laws and regulations in the United States and abroad; or laws that require the reporting of financial information or data accurately. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Activities subject to these laws also involve the improper use of information obtained in the course of clinical trials or creating fraudulent data in our preclinical studies or clinical trials, which could result in regulatory sanctions and cause serious harm to our reputation. We have a code of conduct applicable to all of our employees, but it is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. Additionally, we are subject to the risk that a person could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs,

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contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

**Risks Related to Regulatory Approval of our Product Candidates and Other Legal Compliance Matters**

***If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates, we will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired.*** 

Our product candidates and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, distribution, import and export are subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by comparable authorities in other countries. Before we can commercialize any of our product candidates, we must obtain marketing approval. Currently, all of our product candidates are in development, and we have not received approval to market any of our product candidates from regulatory authorities in any jurisdiction. It is possible that our product candidates, including any product candidates we may seek to develop in the future, will never obtain regulatory approval. Whether the results from our clinical trials will suffice to obtain approval will be a review issue and the FDA may not grant approval and may require that we conduct one or more controlled clinical trials to obtain approval. Additionally, even if FDA does grant approval for one or more of our product candidates, it may be for a more narrow indication than we seek. Regulatory authorities, including the FDA, also may impose significant limitations in the form of narrow indications, warnings or a REMS. These regulatory authorities may require labeling that includes precautions or contra-indications with respect to conditions of use, or they may grant approval subject to the performance of costly post-marketing clinical trials. In addition, regulatory authorities may not approve the labeling claims that are necessary or desirable for the successful commercialization of any product candidates we may develop.

We have only limited experience in filing and supporting the applications necessary to gain regulatory approvals and expect to rely on third-party CROs and/or regulatory consultants to assist us in this process. Securing regulatory approval requires the submission of extensive preclinical and clinical data and supporting information to the various regulatory authorities for each therapeutic indication to establish the product candidate's safety and efficacy. Securing regulatory approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authority. Our product candidates may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use. In addition, regulatory authorities may find fault with our manufacturing process or facilities or that of third-party contract manufacturers. We may also face greater than expected difficulty in manufacturing our product candidates.

The process of obtaining regulatory approvals, both in the United States and abroad, is expensive and often takes many years. If the FDA or a comparable foreign regulatory authority requires that we perform additional preclinical studies or clinical trials, approval, if obtained at all, may be delayed. The length of such a delay varies substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted NDA, premarket approval application, or equivalent application types, may cause delays in the approval or rejection of an application. The FDA and comparable authorities in other countries have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies. Our product candidates could be delayed in receiving, or fail to receive, regulatory approval for many reasons, including the following:

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

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•we may not be able to enroll a sufficient number of patients in our clinical studies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication or a related companion diagnostic is suitable to identify appropriate patient populations;

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

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•we may be unable to demonstrate that a product candidate's clinical and other benefits outweigh its safety risks;

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

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the data collected from clinical trials of our product candidates may not be sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the United States or elsewhere;

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

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change such that our clinical data are insufficient for approval.

Even if we were to obtain approval, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request, thereby narrowing the commercial potential of the product candidate. In addition, regulatory authorities may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates.

If we experience delays in obtaining approval or if we fail to obtain approval of our product candidates, the commercial prospects for our product candidates may be harmed and our ability to generate revenues will be materially impaired.

***Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.*** 

We may submit marketing applications in countries other than the United States. Regulatory authorities in jurisdictions outside of the United States have requirements for approval of product candidates with which we must comply prior to marketing in those jurisdictions. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. If we fail to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.

Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional nonclinical studies or clinical trials as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In short, the foreign regulatory approval process involves all of the risks associated with FDA approval. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we may intend to charge for our products will also be subject to approval.

***Even if we receive regulatory approval for any of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to post-market study requirements, marketing and labeling restrictions, and even recall or market withdrawal if unanticipated safety issues are discovered following approval. In addition, we may be subject to penalties or other enforcement action if we fail to comply with regulatory requirements.*** 

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If the FDA or a comparable foreign regulatory authority approves any of our product candidates, the manufacturing processes, labeling, packaging, distribution, storage, advertising, promotion, import, export, recordkeeping, monitoring, and reporting for our product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, establishment registration and listing, as well as continued compliance with cGMPs and GCPs for any clinical trials that we conduct post-approval. Any regulatory approvals that we receive for our product candidates may also be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing studies, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product.

The FDA may require a REMS in order to approve our product candidates, which could entail requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•revision to the labeling, including limitations on approved uses or the addition of additional warnings, contraindications or other safety information, including boxed warnings;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•imposition of a REMS, which may include distribution or use restrictions;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•requirements to conduct additional post-market clinical trials to assess the safety of the product;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•fines, warning letters or other regulatory enforcement action;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•refusal by the FDA to approve pending applications or supplements to approved applications filed by us;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•product seizure or detention, or refusal to permit the import or export of products; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•injunctions or the imposition of civil or criminal penalties.

The FDA's and other regulatory authorities' policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, which could adversely affect our business, prospects and ability to achieve or sustain profitability.

***If we are unable to successfully validate, develop and obtain regulatory approval for any required companion diagnostic tests for our product candidates or experience significant delays in doing so, we may fail to obtain approval or may not realize the full commercial potential of these product candidates.*** 

In connection with the clinical development of our product candidates for certain indications, we may develop or engage third parties to develop or obtain access to in vitro companion diagnostic tests to identify patient subsets within a disease category who may derive benefit from our product candidates. Such companion diagnostics may be used during our clinical trials and may be required in connection with the FDA approval of our product candidates. To be successful, we or our collaborators will need to address a number of scientific, technical, regulatory and logistical challenges. Companion diagnostics are subject to regulation by the FDA, EMA and other regulatory authorities as medical devices and require separate regulatory approval prior to commercialization.

We may rely on third parties for the design, development and manufacture of companion diagnostic tests for our therapeutic product candidates that may require such tests. If we enter into such collaborative agreements, we will be dependent on the sustained cooperation and effort of our future collaborators in developing and obtaining approval for these companion diagnostics. We and our future collaborators may encounter difficulties in developing and obtaining approval for the companion diagnostics, including issues relating to selectivity/specificity, analytical validation, reproducibility, or clinical validation of companion diagnostics. We and our future collaborators also may encounter difficulties in developing, obtaining regulatory approval for, manufacturing and commercializing companion diagnostics similar to those we face with respect to our therapeutic product candidates themselves, including issues with achieving regulatory clearance or approval, production of sufficient quantities at commercial

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scale and with appropriate quality standards, and in gaining market acceptance. If we are unable to successfully develop companion diagnostics for these therapeutic product candidates, or experience delays in doing so, the development of these therapeutic product candidates may be adversely affected, these therapeutic product candidates may not obtain marketing approval or such approval may be delayed, and we may not realize the full commercial potential of any of these therapeutics that obtain marketing approval. As a result, our business, results of operations and financial condition could be materially harmed. In addition, a diagnostic company with whom we contract may decide to discontinue developing, selling or manufacturing the companion diagnostic test that we anticipate using in connection with development and commercialization of our product candidates or our relationship with such diagnostic company may otherwise terminate. We may not be able to enter into arrangements with another diagnostic company to obtain supplies of an alternative diagnostic test for use in connection with the development and commercialization of our product candidates or do so on commercially reasonable terms, which could adversely affect and/or delay the development or commercialization of our therapeutic product candidates.

***Our relationships with customers, healthcare professionals, and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to significant penalties, including criminal sanctions, administrative civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm and diminished profits and future earnings.*** 

Our current and future business operations and activities may subject us to additional healthcare statutory and regulatory requirements and enforcement by the federal government and the states and foreign governments in which we conduct our business. Healthcare providers and third-party payors play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing approval. Our current and future arrangements with healthcare professionals, third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we research as well as market, sell and distribute our product candidates for which we obtain marketing approval. These laws and regulations may restrict or prohibit a wide range of ownership, pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Restrictions under applicable federal and state healthcare laws and regulations, include the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the federal Anti-Kickback Statute prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal and state healthcare programs such as Medicare and Medicaid. The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers, on the one hand, and prescribers, purchasers and formulary managers, on the other. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the federal civil and criminal false claims, including the federal FCA, which can be enforced through civil whistleblower or qui tam actions, and civil monetary penalties laws, which impose criminal and civil penalties against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. In addition, the government may assert that a claim including items and services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•HIPAA, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the federal physician payment transparency requirements, sometimes referred to as the "Sunshine Act" under the ACA, require certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children's Health Insurance Program to report to the Centers for Medicare & Medicaid Services, or CMS, information related to transfers of value made to physicians (currently defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other

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healthcare professionals (such as nurse practitioners and physicians assistants), and teaching hospitals, as well as information regarding ownership and investment interests of such physicians and their immediate family members;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•HIPAA, as amended by HITECH and its implementing regulations, impose obligations on certain covered entity healthcare providers, health plans, and healthcare clearinghouses and their business associates that perform certain services involving the use or disclosure of individually identifiable health information as well as their covered subcontractors, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•analogous state laws and regulations, such as state anti-kickback and false claims laws may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers. Some state laws require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments to physicians and other health care providers or marketing expenditures. Some state and local laws require certain regulatory licenses to manufacture or distribute our products commercially and/or the registration of pharmaceutical sales representatives. Further, many state laws governing the privacy and security of health information in certain circumstances, differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available, it is possible that some of our business activities, including compensation of physicians with stock or stock options, could, despite efforts to comply, be subject to challenge under current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. Ensuring that our business arrangements with third parties comply with applicable healthcare laws and regulations could involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations were to be found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, contractual damages, integrity oversight and reporting obligations, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. If any of the physicians or other providers or entities with whom we expect to do business is found not to be in compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs. In addition, the approval and commercialization of any of our product candidates outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.

***Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.*** 

The U.S. and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that could prevent or delay marketing approval of our current or future product candidates or any future product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell a product for which we obtain marketing approval. Changes in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example: (i) changes to our manufacturing arrangements, (ii) additions or modifications to product labeling, (iii) the recall or discontinuation of our products or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business. In the U.S., there have been and continue to be a number of legislative initiatives to contain healthcare costs. For example, in March 2010, Patient Protection and ACA was passed, which substantially changed the way healthcare is financed by both governmental and private insurers.

There have been executive, judicial and congressional challenges to certain aspects of the ACA. For example, on July 4, 2025, the OBBBA was signed into law, which narrowed access to ACA marketplace exchange enrollment and declined to extend the ACA enhanced advanced premium tax credits that expired at the end of 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance. The

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OBBBA also is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program. Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired ACA subsidies.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. These changes include aggregate reductions to Medicare payments to providers of 2% per fiscal year, which began in 2013 and will remain in effect until 2032 unless additional Congressional action is taken.

The current administration is pursuing policies to reduce regulations and expenditures across government agencies including at the U.S. Department of Health and Human Services, or HHS, the FDA, CMS and related agencies. These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business. For example, the current administration has announced agreements with several pharmaceutical companies that require the drug manufacturers to offer, through a direct to consumer platform, U.S. patients and Medicaid programs prescription drug Most-Favored Nation pricing equal to or lower than those paid in other developed nations, with additional mandates for direct-to-patient discounts and repatriation of foreign revenues. Other recent actions, for example, include (1) directing agencies to reduce agency workforce and cut programs; (2) directing HHS and other agencies to lower prescription drug costs through a variety of initiatives; (3) imposing tariffs on imported pharmaceutical products; and (4) as part of the Make America Healthy Again Commission's Strategy Report released in September 2025, working across government agencies to increase enforcement on direct-to-consumer pharmaceutical advertising. Additionally, the current administration recently called on Congress to enact "The Great Healthcare Plan," to codify and expand Most-Favored Nation pricing, lower government subsidies to private insurance companies, increase healthcare price transparency, expand pharmaceutical drugs available for over-the-counter purchase, and enact restrictions on pharmacy benefit manager payment methodologies, among other things. These actions and policies may significantly reduce U.S. drug prices, potentially impacting manufacturers' global pricing strategies and profitability, while increasing their operational costs and compliance risks. In June 2024, the U.S. Supreme Court's Loper Bright decision greatly reduced judicial deference to regulatory agencies, which could increase successful legal challenges to federal regulations affecting our operations. Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program. At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In addition, regional health care authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other health care programs. These measures could reduce the ultimate demand for our products, once approved, or put pressure on our product pricing.

Our revenue prospects could be affected by changes in healthcare spending and policy in the U.S. and abroad. We operate in a highly regulated industry and new laws, regulations or judicial decisions, or new interpretations of existing laws, regulations or decisions, related to healthcare availability, the method of delivery or payment for healthcare products and services could negatively impact our business, operations and financial condition.

There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the demand for our current or future product candidates, if we obtain regulatory approval;

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

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our ability to obtain coverage and reimbursement approval for a product;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our ability to generate revenue and achieve or maintain profitability;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the level of taxes that we are required to pay; and

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the availability of capital.

Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors, which may adversely affect our future profitability.

***We are subject to the U.K. Bribery Act 2010, or the Bribery Act, the U.S. Foreign Corrupt Practices Act of 1977, as amended, or the FCPA, and other anti-corruption laws, as well as export control laws, import and customs laws, trade and economic sanctions laws and other laws governing our operations.***

Our operations are subject to anti-corruption laws, including the Bribery Act, the FCPA, the U.S. domestic bribery statute contained in 18 U.S.C. §201, the U.S. Travel Act, and other anti-corruption laws that apply in countries where we do business. The Bribery Act, the FCPA and these other laws generally prohibit us and our employees and intermediaries from authorizing, promising, offering, or providing, directly or indirectly, improper or prohibited payments, or anything else of value, to government officials or other persons to obtain or retain business or gain some other business advantage. Under the Bribery Act, we may also be liable for failing to prevent a person associated with us from committing a bribery offense. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls. We and our commercial partners operate in a number of jurisdictions that pose a high risk of potential Bribery Act or FCPA violations, and we participate in collaborations and relationships with third parties whose corrupt or illegal activities could potentially subject us to liability under the Bribery Act, FCPA or local anti-corruption laws, even if we do not explicitly authorize or have actual knowledge of such activities. In addition, we cannot predict the nature, scope or effect of future regulatory requirements to which our international operations might be subject or the manner in which existing laws might be administered or interpreted.

We are also subject to other laws and regulations governing our international operations, including regulations administered by the governments of the United Kingdom and the United States, and authorities in the European Union, including applicable export control regulations, economic sanctions and embargoes on certain countries and persons, anti-money laundering laws, import and customs requirements and currency exchange regulations, collectively referred to as the Trade Control laws. Compliance with Trade Control laws may create delays in the introduction of our products in international markets or, in some cases, prevent the export of our products to some countries altogether. Furthermore, Trade Control laws prohibit the provision of certain products and services to countries, governments and persons targeted by sanctions.

There is no assurance that we will be completely effective in ensuring our compliance with all applicable anti-corruption laws, including the Bribery Act, the FCPA or other legal requirements, including Trade Control laws. If we are not in compliance with the Bribery Act, the FCPA and other anti-corruption laws or Trade Control laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses, which could have an adverse impact on our business, financial condition, results of operations and liquidity. Likewise, any investigation of any potential violations of the Bribery Act, the FCPA, other anti-corruption laws or Trade Control laws by United Kingdom, United States or other authorities could also have an adverse impact on our reputation, our business, results of operations and financial condition.

***If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.***

We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammable materials, including chemicals and biological materials. Our operations also produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties. Furthermore, environmental laws and regulations are complex, change frequently and have tended to become more stringent. We cannot predict the impact of such changes and cannot be certain of our future compliance. In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our

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research, development or production efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Although we maintain workers' compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials or other work-related injuries, this insurance may not provide adequate coverage against potential liabilities. In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or production efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions or liabilities, which could materially adversely affect our business, financial condition, results of operations and prospects.

**Risks Related to the Commercialization of our Product Candidates**

***If we are unable to establish sales, marketing and distribution capabilities for our product candidates, or enter into sales, marketing and distribution agreements with third parties, we may not be successful in commercializing our product candidates, if approved.*** 

We currently plan to work to build our commercialization capabilities internally over time such that we are able to commercialize any product candidate for which we may obtain regulatory approval. However, we currently have no sales, marketing or distribution capabilities and have no experience in marketing or distributing pharmaceutical products. To achieve commercial success for any product candidate for which we may obtain marketing approval, we will need to expand our sales and marketing organization and establish logistics and distribution processes to commercialize and deliver our product candidates to patients and healthcare providers. These activities will be expensive and time-consuming and will require significant attention of our executive officers to manage. There are risks involved in establishing our own sales and marketing capabilities, as well as with entering into arrangements with third parties to perform these services. Additionally, our beliefs that our products will be commercially viable have not been tested.

If we are unable or decide not to establish internal sales, marketing and distribution capabilities, we would have to pursue collaborative arrangements regarding the sales and marketing of our products. However, we may not be successful in entering into arrangements with third parties to sell, market and distribute our product candidates or may be unable to do so on terms that are favorable to us, or if we are able to do so, that they would be effective and successful in commercializing our products. Our product revenues and our profitability, if any, would likely to be lower than if we were to sell, market and distribute any product candidates that we develop ourselves. In addition, we would have limited control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our product candidates effectively.

If we do not establish sales, marketing and distribution capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates in the United States or overseas.

***We operate in a rapidly changing industry and face significant competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.*** 

The development and commercialization of new biopharmaceutical products is highly competitive and subject to rapid and significant technological advancements. We face competition from major multi-national pharmaceutical companies, biotechnology companies and specialty pharmaceutical companies with respect to our current and future product candidates that we may develop and commercialize in the future. There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of product candidates for the treatment of cancer. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Potential competitors also include academic institutions, government agencies and other public and private research organizations.

We anticipate that we will compete with Alpelisib, Inavolisib, Capivasertib, Everolimus and Temsirolimus, all of which are approved drugs that target the PI3K/AKT/mTOR pathway. In addition, we are aware of several additional product candidates in clinical development that could potentially pose a direct competitive threat to PIKTOR, particularly for the treatment of advanced HR+/HER2- breast cancer. These product candidates include Gedatolisib, an IV pan-PI3K + mTORC1/2 inhibitor from Celcuity, whose New Drug Application for HR+/HER2-, PIK3CA wild-type metastatic breast cancer was accepted by the FDA with Priority Review and a Prescription Drug

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User Fee Act goal date of July 17, 2026; Tersolisib, an oral mutant-specific PI3Kα inhibitor from Eli Lilly currently in Phase 3 trials for HR+/HER2- breast cancer; Zovegalisib, an oral mutant-selective PI3Kα inhibitor from Relay Therapeutics currently in Phase 3 trials for advanced HR+/HER2- breast cancer; Afuresertib, an oral pan AKT inhibitor from Laekna Therapeutics currently in Phase 3 trials for advanced HR+/HER2- breast cancer; Paxalisib, an oral brain penetrant PI3K/mTOR inhibitor from Kazia Therapeutics currently in Phase 3 trials in glioblastoma; SNV4818, an oral pan-mutant-selective PI3Kα inhibitor acquired by Novartis from Synnovation Therapeutics in March 2026, currently in Phase 1/2 trials for HR+/HER2- breast cancer and other solid tumors; and OKI-219, an oral mutant-specific PI3Kα inhibitor from OnKure Therapeutics, currently in Phase 1/2 trials for HR+/HER2- breast cancer and other solid tumors. Our competitive thesis is that multi-node inhibition is a superior mechanism to provide deeper, more tolerable suppression of the PI3K/AKT/mTOR pathway than is currently available in approved therapeutics. If our thesis is incorrect, or if new modalities are developed that better suppress the PI3K/AKT/mTOR pathway, our business would be materially and adversely impacted.

Several of these competing product candidates are in Phase 3 registrational trials with potential approval timelines that are ahead of our development timeline for PIKTOR. In particular, Celcuity recently had its New Drug Application for gedatolisib in HR+/HER2-, PIK3CA wild-type metastatic breast cancer accepted by the FDA with Priority Review and a Prescription Drug User Fee Act goal date of July 17, 2026. If one or more competitors obtains regulatory approval and establishes a market position before we are able to enter the market, it could significantly diminish the commercial opportunity for PIKTOR, particularly if the approved product addresses the same patient population or demonstrates a superior safety or efficacy profile. Additionally, mutant-selective PI3Ka inhibitors being developed by Eli Lilly (tersolisib) and Relay Therapeutics (zovegalisib) are also in Phase 3 development and, if approved, could reduce the addressable market for PIKTOR by providing an alternative targeted approach for patients with PI3K-mutant tumors. Large pharmaceutical companies are making significant investments in the PI3K/AKT/mTOR space. For example, in March 2026, Novartis announced the acquisition of Synnovation Therapeutics' pan-mutant-selective PI3Kα inhibitor program, including SNV4818, which is currently in Phase 1/2 clinical development for HR+/HER2- breast cancer. This and similar acquisitions could result in additional well-resourced competitors with established commercial infrastructure entering the market ahead of or concurrent with PIKTOR, which could significantly diminish our commercial opportunity.

Our competitors with development-stage programs may obtain marketing approval from the FDA or other comparable regulatory authorities for their product candidates more rapidly than we do, and they could establish a strong market position before we are able to enter the market. In addition, our competitors may succeed in developing, acquiring or licensing technologies and products that are more effective, more effectively marketed and sold or less costly than any product candidates that we may develop, which could render our product candidates non-competitive and obsolete.

Many of our competitors, either alone or with their strategic collaborators, have substantially greater financial, technical and human resources than we do. Accordingly, our competitors may be more successful than we are in obtaining approval for treatments and achieving widespread market acceptance, which may render our treatments obsolete or non-competitive. Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of our competitors. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical studies, as well as in acquiring technologies complementary to, or necessary for, our programs. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive or better reimbursed than any products that we may commercialize. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position for either their product or a specific indication before we are able to enter the market.

***Even if any of our product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.*** 

Even if we obtain approvals from the FDA or other comparable regulatory agencies and are able to initiate commercialization of our product candidates or any other product candidates we develop, the product candidate may

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not achieve market acceptance among physicians, patients, hospitals, including pharmacy directors, and third-party payors and, ultimately, may not be commercially successful. The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the clinical indications for which our product candidates are approved;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•physicians, hospitals, cancer treatment centers, and patients considering our product candidates as a safe and effective treatment;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the potential and perceived advantages of our product candidates over alternative treatments;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the prevalence and severity of any side effects;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•product labeling or product insert requirements of the FDA or other regulatory authorities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•limitations or warnings contained in the labeling approved by the FDA;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the timing of market introduction of our product candidates as well as competitive products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the cost of treatment in relation to alternative treatments;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the amount of upfront costs or training required for physicians to administer our product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the availability of coverage, adequate reimbursement from, and our ability to negotiate pricing with, third-party payors and government authorities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the willingness of patients to pay out-of-pocket in the absence of comprehensive coverage and reimbursement by third-party payors and government authorities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the effectiveness of our sales and marketing efforts and distribution support.

Our efforts to educate physicians, patients, third-party payors and others in the medical community on the benefits of our product candidates, if approved, may require significant resources and may never be successful. Because we expect sales of our product candidates, if approved, to generate substantially all of our product revenue for the foreseeable future, the failure of our product candidates to find market acceptance could harm our business and could require us to seek additional financing.

Even if our product candidates, if approved, achieve market acceptance, we may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than our products, are more cost effective or render our products obsolete.

***Coverage and adequate reimbursement may not be available for our current or any future product candidates, which could make it difficult for us to sell profitably, if approved.*** 

Market acceptance and sales of any product candidates, if approved, that we commercialize will depend in part on the extent to which reimbursement for these products and related treatments will be available from third-party payors, including government health administration authorities, managed care organizations and private health insurers. Third-party payors decide which therapies they will pay for and establish reimbursement levels. In the United States, the principal decisions about reimbursement for new medicines are typically made by CMS, an agency within HHS. CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare and private payors tend to follow CMS to a substantial degree. However, decisions regarding the extent of coverage and amount of reimbursement to be provided for any product candidates that we develop will be made on a payor-by-payor basis. Further, no uniform policy for coverage and reimbursement exists in the United States, and coverage and reimbursement can differ significantly from payor to payor. As a result, one payor's determination to provide coverage for a drug does not assure that other payors will also provide coverage and adequate reimbursement for the drug. Additionally, a third-party payor's decision to provide coverage for a therapy does not imply that an adequate reimbursement rate to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investment will be approved. Third-party payors are increasingly challenging the price, examining the medical necessity and reviewing the cost-effectiveness of medical products, therapies and services, in addition to questioning their safety and efficacy. We may incur significant costs to conduct expensive

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pharmaco-economic studies in order to demonstrate the medical necessity and cost-effectiveness of our product candidates, in addition to the costs required to obtain FDA approvals. Our product candidates may not be considered medically necessary or cost-effective. Each payor determines whether or not it will provide coverage for a therapy, what amount it will pay the manufacturer for the therapy, and on what tier of its list of covered drugs, or formulary, it will be placed. The position on a payor's formulary generally determines the co-payment that a patient will need to make to obtain the therapy and can strongly influence the adoption of such therapy by patients and physicians. Patients who are prescribed treatments for their conditions and providers prescribing such services generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Patients are unlikely to use our products, and providers are unlikely to prescribe our products, unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our products and their administration. Therefore, coverage and adequate reimbursement is critical to new medical product acceptance.

In addition, companion diagnostic tests require coverage and reimbursement separate and apart from the coverage and reimbursement for their companion pharmaceutical or biological products. Similar challenges to obtaining coverage and reimbursement, applicable to pharmaceutical or biological products, will apply to companion diagnostics. Additionally, if any companion diagnostic provider is unable to obtain reimbursement or is inadequately reimbursed, that may limit the availability of such companion diagnostic, which could negatively impact prescriptions for our product candidates, if approved.

A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. We cannot be sure that coverage and reimbursement will be available for any drug that we commercialize and, if reimbursement is available, what the level of reimbursement will be. For example, HHS imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation on an annual basis. HHS has also been empowered to negotiate the price of certain single-source drugs that have been on the market for at least seven (7) years and biologics that have been on the market for at least eleven (11) years covered under Medicare as part of the Medicare Drug Price Negotiation Program. Each year up to twenty (20) products will be selected by HHS for the Medicare Drug Price Negotiation Program. Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis. Even if favorable coverage and reimbursement status is attained for one or more product candidates for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. Inadequate coverage and reimbursement may impact the demand for, or the price of, any drug for which we obtain marketing approval. If coverage and adequate reimbursement are not available, or are available only to limited levels, we may not be able to successfully commercialize our current and any future product candidates that we develop. In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health systems. In general, the prices of medicines under such systems are substantially lower than in the United States. Other countries allow companies to fix their own prices for medicines, but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our product candidates. Accordingly, in markets outside the United States, the reimbursement for products may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenues and profits.

In addition, our NEAAR program, which seeks to restrict patient intake of specific non-essential amino acids to suppress tumor growth, represents a novel therapeutic approach for which there is limited regulatory precedent. Dietary interventions are not subject to the same well-established regulatory approval pathways as pharmaceutical products, and it is unclear how the FDA or comparable foreign regulatory authorities would evaluate a dietary regimen as a component of a cancer treatment regimen. Even if we are able to generate clinical evidence supporting the use of NEAAR in combination with our other product candidates, third-party payors may be unwilling to provide coverage or reimbursement for a prescribed dietary intervention, which could limit patient adoption and reduce any potential commercial value of the program.

We cannot be sure that coverage and reimbursement in the United States or elsewhere will be available for any product that we may develop, and any reimbursement that may become available may be decreased or eliminated in the future.

***Our business, operational and financial goals may not be attainable if the market opportunities for our products are smaller than we expect. Our internal research and third-party estimates may not accurately reflect the market opportunities for PIKTOR or our other product candidates today or in the future.*** 

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The total market opportunities that we believe exist are based on a variety of assumptions and estimates, including the size of the addressable patient population in applicable jurisdictions, the penetration of other drugs in these markets, the number of potential companion diagnostic programs we will be able to successfully pursue, the amount of potential milestone payments that we could receive in companion diagnostic programs, the number of patients we will test in clinical trials, the price we will be able to charge for our products and the total annual number of cancer patients with undiagnosed abnormal cell signaling. In addition, we have relied on third-party publications, research, surveys and studies for information related to determining market opportunities, including without limitation, information on the number of cancer patients and those receiving various forms of treatment, the cost of drug therapy, the amount of revenue generated from various types of drug therapy, the objective response rates of drug therapies, the number of deaths caused by cancer and the expected growth in cancer drug therapy and diagnostic markets. Our internal research and estimates on market opportunities have been verified by independent sources, but any or all of our assumptions and/or estimates may prove to be incorrect for several reasons, such as inaccurate reports or information that we have relied on, potential patients or providers not being amenable to using our products or such patients becoming difficult to identify and access, limited reimbursement for our products, pricing pressure due to availability of alternative drugs or an inability to obtain the necessary regulatory approvals for new indications. If any or all of our assumptions and estimates prove inaccurate, we may not attain our business, operational and financial goals.

***Inadequate funding for the FDA, the SEC and other government agencies 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.*** 

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 the SEC and other government agencies 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.

Disruptions at the FDA and other agencies may also slow the time necessary for product candidates to be reviewed and/or approved by necessary government agencies, which could adversely affect our business. 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, or if global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

**Risks Related to Our Intellectual Property** 

***If we are unable to obtain and maintain effective patent protection for our technology and product candidates, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets***

We rely upon a combination of patents, trade secret protection, trademarks, and confidentiality agreements to protect the intellectual property related to our product candidates and development programs. Our success depends in large part on our ability to obtain and maintain patents and other intellectual property protection in the United States and in other countries with respect to various proprietary elements of our product candidates, such as, for example, our product formulations and processes for manufacturing our products and our ability to maintain and control the confidentiality of our trade secrets and confidential information critical to our business.

We have sought to protect our proprietary position by filing patent applications in the United States and abroad related to our products that are important to our business. The patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. There is no guarantee that any patent application

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we file will result in an issued patent having claims that protect our products; and, as a result, we may not be able to effectively prevent others from commercializing competitive products. Additionally, while the basic requirements for patentability are similar across jurisdictions, each jurisdiction has its own specific requirements for patentability. We cannot guarantee that we will obtain identical or similar patent protection covering our products in all jurisdictions where we file patent applications. If the patent applications we hold or have in-licensed with respect to our development programs and product candidates fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for any product candidate, it could dissuade companies from collaborating with us to develop product candidates and threaten our ability to commercialize any product candidates that are approved. Any such outcome could have a materially adverse effect on our business.

The patents and patent applications that we own or in-license may fail to result in issued patents with claims that protect our present and future product candidates in the United States or in other foreign countries. There is no assurance that all of the potentially relevant prior art relating to our patents and patent applications has been found, which can prevent a patent from issuing from a pending patent application, or be used to invalidate a patent. Even if patents do successfully issue and even if such patents cover our present or future product candidates, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowed, invalidated or held unenforceable. Any successful opposition to these patents or any other patents owned by or licensed to us could deprive us of rights necessary for the successful commercialization of any present or future product candidates or methods of using such. Further, if we encounter delays in regulatory approvals, the period of time during which we could market a product candidate under patent protection could be reduced.

The patent position of biopharmaceutical companies are generally uncertain and involve complex legal and factual questions and has been and will continue to be the subject of litigation and new legislation. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. For example, many countries restrict the patentability of methods of treatment of the human body. Publications of discoveries in scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we were the first to file for patent protection of such inventions. As a result of these and other factors, the issuance, scope, validity, enforceability and commercial value of our patent rights are uncertain. The pending patent applications that we own or license may fail to result in issued patents with claims that cover our product candidates in the United States or in other countries for many reasons. Our pending and future patent applications may not result in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection. There is no assurance that all potentially relevant prior art relating to our patents and patent applications has been found, considered or cited during patent prosecution, which can be used to invalidate a patent or prevent a patent from issuing from a pending patent application.

Moreover, we have in the past, and may in the future be subject to a third-party pre-issuance submission of prior art to the USPTO. We may also become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our patent rights or the patent rights of others. For example, patents granted by the European Patent Office may be opposed by any person within nine months from the publication of their grant and, in addition, may be challenged before national courts at any time. The costs of defending our patents or enforcing our proprietary rights in post-issuance administrative proceedings and litigation can be substantial and the outcome can be uncertain. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

Furthermore, even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property, provide exclusivity for our product candidates or prevent others from designing around our claims. Any of these outcomes could impair our ability to prevent competitors from using the technologies claimed in any patents issued to us, which may have an adverse impact on our business. If the breadth or strength of protection

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provided by the patents and patent applications we hold, license or pursue with respect to our product candidates is threatened, it could threaten our ability to prevent third parties from using the same technologies that we use in our product candidates.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products. Generally, issued patents are granted a term of 20 years from the earliest claimed non-provisional filing date. In certain instances, patent term can be adjusted to recapture a portion of delay by the USPTO in examining the patent application (patent term adjustment) or extended to account for term effectively lost as a result of the FDA regulatory review period (patent term extension), or both. The scope of patent protection may also be limited. Without patent protection for our current or future product candidates, we may be open to competition from generic versions of such products. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

Method of use patents protect the use of a product for the specified method or indication. In the absence of separate composition of matter protection, this type of patent does not prevent a competitor from making and marketing a product that is identical to our product candidate(s) for an indication that is outside of the methods of use claimed in our patents. Moreover, even if competitor products are not approved for use in our patented indications, and our competitors do not actively promote their products for indications that are covered by our patents, clinicians may prescribe these competitor products "off-label." Although off-label prescriptions may infringe or contribute to the infringement of method of use patents, such infringement is difficult to prevent or prosecute.

***We may not identify relevant patents or may incorrectly interpret the relevance, scope or expiration of a patent, which might adversely affect our ability to develop and market our products.***

We cannot guarantee that patent searches, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete and thorough, nor can we be certain that we have identified each and every patent and pending application in the United States and abroad that is relevant to or necessary for the commercialization of our product candidates in any jurisdiction.

The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent's prosecution history. Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect, which may negatively impact our ability to market our products or pipeline candidates. We may incorrectly determine that our products are not covered by a third-party patent. Further, we may conclude that a well-informed court or other tribunal would find the claims of a relevant third-party patent to be invalid based on prior art, enablement, written description, or other ground, and that conclusion may be incorrect, which may negatively impact our ability to market our products or pipeline molecules.

Many patents may cover a marketed product, including the composition of the product, methods of use, formulations, cell line constructs, vectors, growth media, production processes and purification processes. The identification of all patents and their expiration dates relevant to the production and sale of a reference product is extraordinarily complex and requires sophisticated legal knowledge in the relevant jurisdiction. It may be impossible to identify all patents in all jurisdictions relevant to a marketed product. We may not identify all relevant patents, or incorrectly determine their expiration dates, which may negatively impact our ability to develop and market our products.

Failure to identify and correctly interpret relevant patents may negatively impact our ability to develop, market and commercialize our products.

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***Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.***

The United States has enacted and implemented wide-ranging patent reform legislation. The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on actions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce patents that we have licensed or that we might obtain in the future. For example, recent decisions raise questions regarding the award of patent term adjustment, or PTA, for patents in families where related patents have issued without PTA. Thus, it cannot be said with certainty how PTA will/will not be viewed in future and whether patent expiration dates may be impacted.

Similarly, changes in patent law and regulations in other countries or jurisdictions or changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we have licensed or that we may obtain in the future. For example, the complexity and uncertainty of European patent laws have also increased in recent years. In Europe, a new unitary patent system took effect on June 1, 2023, which will significantly impact European patents, including those granted before the introduction of such a system. Under the unitary patent system, all European patents, including those issued prior to June 1, 2023, now by default automatically fall under the jurisdiction of a new European Unified Patent Court, or the UPC, for litigation involving such patents. As the UPC is a relatively new court system, there is uncertainty regarding litigation at the UPC. Our European patent applications, if issued, could be challenged in the UPC. During the first seven years of the UPC's existence, the UPC legislation allows a patent owner to opt its European patents out of the jurisdiction of the UPC. We may decide to opt out our future European patents from the UPC, but doing so may preclude us from realizing the benefits of the UPC. Moreover, if we do not meet all of the formalities and requirements for opt-out under the UPC, our future European patents could remain under the jurisdiction of the UPC. The UPC will provide our competitors with a new forum to centrally revoke our European patents and allow for the possibility of a competitor to obtain a pan-European injunction. It is uncertain how the UPC will impact granted European patents in the pharmaceutical industry.

Additionally, recent reforms and changes at government agencies of the United States and those of non-U.S. jurisdictions could increase the uncertainties and costs surrounding the prosecution or maintenance of our patent applications, and the maintenance, enforcement, or defense of our issued patents. For example, the ability of the USPTO and other applicable patent authorities to properly administer their functions is highly dependent on the levels of funding available to the agency and their ability to retain key personnel and fill key leadership appointments, among various factors. Termination of employees or delays in replacing or hiring for key positions could significantly impact the ability of the USPTO and other applicable patent authorities to fulfill their functions and could greatly impact our ability to timely and adequately prosecute or maintain our patent applications, and our ability to timely and adequately maintain, enforce, or defend our issued patents.

***Third-party claims or litigation alleging infringement of patents or other proprietary rights, or seeking to invalidate our patents or other proprietary rights, may delay or prevent our development and commercialization efforts.***

Our commercial success depends in part on avoiding infringement of the patents and proprietary rights of third parties. There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the pharmaceutical industry, including patent infringement lawsuits, interferences, reexamination, derivation and administrative law proceedings, inter partes review and post-grant review before the USPTO, as well as oppositions and similar processes in foreign jurisdictions. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing product candidates. As the biopharmaceutical industry expands and more patents are issued, the risk increases that our product candidates or other business activities may be subject to claims of infringement of the patent rights of third parties. Third parties may assert that we are employing their proprietary technology without authorization.

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There may be third-party patents or patent applications with claims to compositions, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our product candidates. Moreover, because patent applications can take many years to issue, there may be currently pending patent applications that may later result in issued patents covering our product candidates. The existence of any patent with valid and enforceable claims covering one or more of our product candidates could cause substantial delays in our ability to introduce a candidate into the U.S. market if the term of such patent extends beyond our desired product launch date.

There may also be patent applications that have been filed but not published and if such applications issue as patents, they could be asserted against us. For example, in most cases, a patent filed today would not become known to industry participants for at least 18 months given patent rules applicable in most jurisdictions that do not require publication of patent applications until 18 months after filing.

In addition, third parties may obtain patent rights in the future and claim that use of our technologies infringes upon these rights. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of any of our product candidates, any molecules formed during the manufacturing process or any final product itself, the holders of any such patents may be able to block our ability to commercialize such product candidate unless we obtained a license under the applicable patents, or until such patents expire. Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of our formulations, processes for manufacture or methods of use, the holders of any such patent may be able to block our ability to develop and commercialize the applicable product candidate unless we obtained a license or until such patent expires. In either case, such a license may not be available on commercially reasonable terms.

Furthermore, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our technologies, product candidate(s), or the use of our product candidate(s). As such, there may be applications of others now pending or recently revived patents of which we are unaware. These patent applications may later result in issued patents, or the revival of previously abandoned patents, that may be infringed by the manufacture, use, or sale of our technologies or product candidate(s) or will prevent, limit, or otherwise interfere with our ability to make, use, or sell our technologies and product candidate(s).

Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize one or more of our product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful infringement or other intellectual property claim against us, we may have to pay substantial damages, including treble damages and attorneys' fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our affected products, which may be impossible or require substantial time and monetary expenditure. We cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms.

In addition to infringement claims against us, we may become a party to other patent litigation and other proceedings, including interference, derivation or post-grant proceedings declared or granted by the USPTO and similar proceedings in foreign countries, regarding intellectual property rights with respect to our products. An unfavorable outcome in any such proceedings could require us to cease using the related technology or to attempt to license rights to it from the prevailing party or could cause us to lose valuable intellectual property rights. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms, if any license is offered at all. Litigation or other proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees. We may also become involved in disputes with others regarding the ownership of intellectual property rights.

Third parties may submit applications for patent term extensions in the United States or other jurisdictions where similar extensions are available and/or Supplementary Protection Certificates in the EU states seeking to extend certain patent protection that, if approved, may interfere with or delay the launch of one or more of our product candidates.

The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. Patent litigation and other proceedings may fail, and even if successful, may result in substantial costs and distract our management and other employees. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could impair our ability to compete in the marketplace.

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Furthermore, as the patent landscape is crowded and highly competitive, even in the absence of litigation we may need to obtain licenses from third parties to advance our research or allow commercialization of our product candidates. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. Even if we are able to obtain a license, it may be non-exclusive, which means that our competitors may also receive access to the same technologies licensed to us. In that event, we may face commercial competition, which could harm our business. We cannot provide any assurances that third-party patents do not exist which might be enforced against product candidates resulting in either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties or other forms of compensation to third parties.

***We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.*** 

A third party may hold intellectual property rights, including patent rights, that are important or necessary to the development or manufacture of our product candidates. It may be necessary for us to use the patented or proprietary technology of third parties to commercialize our product candidates, in which case we would be required to obtain a license from these third parties. Such a license may not be available on commercially reasonable terms, or at all, and we could be forced to accept unfavorable contractual terms. If we are unable to obtain such licenses on commercially reasonable terms, our business could be harmed.

The licensing and acquisition of third-party intellectual property rights is a competitive practice, and companies that may be more established, or have greater resources than we do, may also be pursuing strategies to license or acquire third-party intellectual property rights that we may consider necessary or attractive in order to commercialize our product candidates. More established companies may have a competitive advantage over us due to their larger size and cash resources or greater clinical development and commercialization capabilities. We may not be able to successfully complete such negotiations and ultimately acquire the rights to the intellectual property surrounding the additional product candidates that we may seek to acquire.

***We may develop or license intellectual property for which development was funded or otherwise assisted by, the U.S. government and/or government agencies, such as the National Institutes of Health, for development of our technology and product candidates. Failure to meet our own obligations to future licensors or upstream licensors, including such government agencies, may result in the loss of our rights to such intellectual property, which could harm our business.***

The U.S. government and/or government agencies may provide funding, facilities, personnel, or other assistance in connection with the development of the intellectual property rights owned by or licensed to us. The U.S. government and/or government agencies may retain rights in such intellectual property, including the right to grant or require us to grant mandatory licenses or sublicenses to such intellectual property to third parties under certain specified circumstances, including if it is necessary to meet health and safety needs that we are not reasonably satisfying or if it is necessary to meet requirements for public use specified by federal regulations, or to manufacture products in the United States. Any exercise of such rights, including with respect to any such required sublicense of these licenses, could result in the loss of significant rights and could harm our ability to commercialize licensed products. For example, research resulting in future in-licensed patent rights and technology that was funded in part by the U.S. government could result in the government having certain rights, or march-in rights, to such patent rights and technology which may permit the government to disclose our confidential information to third parties and to exercise march-in rights to use or allow third parties to use our licensed technology, potentially on unfavorable terms or without adequate compensation.

***We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time-consuming and unsuccessful.***

Competitors may infringe or otherwise violate our patents, the patents of our licensors or our other intellectual property rights. To counter infringement or unauthorized use, we may be required to file legal claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours or our licensors is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing. The initiation of a claim against a third party may also cause the third party to bring counter claims against us such as claims asserting that our patents are invalid

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and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, non-enablement, written description, or lack of patentable subject matter. Grounds for an unenforceability assertion could be an allegation that someone connected with the prosecution of the patent withheld relevant material information from the USPTO or made a materially misleading statement during prosecution. Third parties may also raise similar validity claims before the USPTO in post-grant proceedings such as ex parte reexaminations, inter partes review or post-grant review, or oppositions or similar proceedings outside the United States, in parallel with litigation or even outside the context of litigation. Because of a lower evidentiary standard in these USPTO post-grant proceedings compared to the evidentiary standard in United States federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. The outcome following legal assertions of invalidity and unenforceability is unpredictable, and there is a risk that a court will decide that a patent of ours is invalid or unenforceable, in whole or in part, and that we do not have the right to stop the other party from using the invention at issue. There is also a risk that, even if the validity of such patents is upheld, the court will construe the patent's claims narrowly and decide that we do not have the right to stop the other party from using the invention at issue on the grounds that our patent claims do not cover the invention or that the other party's use of our patented technology falls under the safe harbor to patent infringement under 35 U.S.C. § 271(e)(1). An adverse outcome in a litigation or proceeding involving our patents could limit our ability to assert our patents against those parties or other competitors and may curtail or preclude our ability to exclude third parties from making and selling similar or competitive products. Any of these occurrences could adversely affect our competitive business position, business prospects and financial condition. Even if we establish infringement, the court may decide not to grant an injunction against further infringing activity and instead award only monetary damages, which may or may not be an adequate remedy.

We cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. For the patents and patent applications that we have licensed, we may have limited or no right to participate in the defense of any licensed patents against challenge by a third party. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of any future patent protection on our current or future product candidates. Such a loss of patent protection could harm our business.

We may not be able to prevent, alone or with our licensors, misappropriation of our intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the United States. Our business could be harmed if in litigation the prevailing party does not offer us a license on commercially reasonable terms. Any litigation or other proceedings to enforce our intellectual property rights may fail, and even if successful, may result in substantial costs and distract our management and other employees.

Similarly, if we assert trademark infringement claims, a court may determine that the marks we have asserted are invalid or unenforceable, or that the party against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimately be forced to cease use of such trademarks.

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Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have an adverse effect on the market price of common shares. Moreover, there can be no assurance that we will have sufficient financial or other resources to file and pursue such infringement claims, which typically last for years before they are concluded. Even if we ultimately prevail in such claims, the monetary cost of such litigation and the diversion of the attention of our management and scientific personnel could outweigh any benefit we receive as a result of the proceedings.

***We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.***

We employ individuals and retain independent contractors and consultants who were previously employed at universities or other pharmaceutical companies, including our competitors or potential competitors. Although we seek to protect our ownership of intellectual property rights by ensuring that our agreements with our employees, independent contractors, consultants, collaborators and other third parties with whom we do business include provisions requiring such parties to assign rights in inventions to us, we may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information of such persons' former companies or other third parties. We may also be subject to claims that such persons or other third parties have an ownership interest in our intellectual property. Litigation may be necessary to defend against these claims. There is no guarantee of success in defending these claims, and if we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

In addition, while we require our employees, consultants and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that we regard as our own, which may result in claims by or against us asserting ownership of such intellectual property. If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights. Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction to our senior management and scientific personnel.

***If we fail to comply with our obligations in the agreements under which we license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.***

We are party to certain license agreements (e.g. with Takeda and The Regents) pursuant to which we were granted rights to intellectual property in connection with the development, manufacture and commercialization of certain product candidates. If we fail to comply with our obligations under these agreements or if we are subject to a bankruptcy, we may be required to make certain payments to the licensor of our license or the licensor may have the right to terminate the license, and in the event of termination we may not be able to develop or market products covered by the license. In the event we breach any of our obligations under these agreements, we may incur significant liability to our research and licensing partners. Disputes may arise regarding intellectual property subject to a licensing agreement, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the scope of rights granted under the license agreement and other interpretation-related issues;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the sublicensing of patents and other rights;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our diligence obligations under the license agreement and what activities satisfy those diligence obligations;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and our collaborators;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the priority of invention of patented technology.

If disputes over intellectual property and other rights that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates and that could harm our business.

In addition, our license agreements do, and we expect that future license agreements will, impose various diligence, milestone payment, royalty, insurance and/or other obligations on us. If we breach any material obligations, or use the intellectual property licensed to us in an unauthorized manner, we may be required to pay damages and the licensor(s) may have the right to terminate the license, which could result in us being unable to develop, manufacture and sell products that are covered by the licensed technology or enable a competitor to gain access to the licensed technology, and could compromise our development and commercialization efforts for our product candidates.

***We may be subject to claims challenging the inventorship of our patent filings and other intellectual property.***

We may in the future be subject to claims that former employees, collaborators or other third parties have an interest in our patent applications or patents we may be granted or other intellectual property as an inventor or co-inventor. For example, we may have inventorship or ownership disputes arise from conflicting obligations of consultants or others who are involved in developing our product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship or ownership. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of or right to use valuable intellectual property. Such an outcome could harm our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

***Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business.*** 

We expect to rely on trademarks as one means to distinguish any of our product candidates that are approved for marketing from the products of our competitors. We have not yet selected trademarks for our product candidates and have not yet begun the process of applying to register trademarks for our product candidates. Once we select trademarks and apply to register them, our trademark applications may not be approved. Third parties may oppose our trademark applications, or otherwise challenge our use of the trademarks. In the event that our trademarks are successfully challenged, we could be forced to rebrand our products, which could result in loss of brand recognition and could require us to devote resources to advertising and marketing new brands. Our competitors may infringe our trademarks and we may not have adequate resources to enforce our trademarks.

In addition, any proprietary name we propose to use with our product candidates or any other product candidate in the United States must be approved by the FDA, regardless of whether we have registered it, or applied to register it, as a trademark. The FDA typically conducts a review of proposed product names, including an evaluation of the potential for confusion with other product names. If the FDA objects to any of our proposed proprietary product names, we may be required to expend significant additional resources in an effort to identify a suitable proprietary product name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA.

***Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.***

While we have filed patent applications to protect certain aspects of our own proprietary formulation and process developments, we also rely on trade secret protection and confidentiality agreements to protect proprietary scientific, business and technical information and know-how that is not or may not be patentable or that we elect not to patent. However, confidential information and trade secrets can be difficult to protect. We may need to share our trade secrets and proprietary know-how with current or future partners, collaborators, contractors, and others located in countries at heightened risk of theft of trade secrets, including through direct intrusion by private parties or foreign actors, and

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those affiliated with or controlled by state actors. Moreover, the information embodied in our trade secrets and confidential information may be independently and legitimately developed or discovered by third parties without any improper use of or reference to information or trade secrets. We seek to protect the scientific, technical and business information supporting our operations, as well as the confidential information relating specifically to our product candidates by entering into confidentiality agreements with parties to whom we need to disclose our confidential information, such as, our employees, consultants, board members, contractors, potential collaborators and financial investors. However, we cannot be certain that such agreements have been entered into with all relevant parties. We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems, but it is possible that these security measures could be breached. While we have confidence in these individuals, organizations and systems, agreements or security measures may be breached and we may not have adequate remedies for any breach. Our confidential information and trade secrets thus may become known by our competitors in ways we cannot prove or remedy.

Although we require all of our employees and consultants to assign their inventions to us, and all of our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information or technology to enter into confidentiality agreements, we cannot provide any assurances that all such agreements have been duly executed. We cannot guarantee that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. For example, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.

Misappropriation or unauthorized disclosure of our trade secrets could impair our competitive position and may harm our business. Additionally, if the steps taken to maintain our trade secrets are deemed inadequate, we may have insufficient recourse against third parties for misappropriating any trade secret. We cannot guarantee that our employees, former employees or consultants will not file patent applications claiming our inventions. Because of the "first-to-file" laws in the United States, such unauthorized patent application filings may defeat our attempts to obtain patents on our own inventions.

***We may not be able to protect our intellectual property rights throughout the world, which could impair our business.***

Filing, prosecuting, defending and enforcing patents and trademarks on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Further, licensing partners may choose not to file patent or trademark applications in certain jurisdictions in which we may obtain commercial rights, thereby precluding the possibility of later obtaining patent protection in these countries. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States or importing products made using our inventions into the United States or other jurisdictions and we may not be able to use our trademarks in all countries or prevent others from using or registering similar trademarks. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and may also export infringing products to territories where we have patent protection, but the ability to enforce our patents is not as strong as that in the United States. These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not being approved, and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages

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or other remedies awarded, if any, may not be commercially meaningful. Governments of some foreign countries may force us to license our patents to third parties on terms that are not commercially reasonable or acceptable to us. In addition, many countries limit the enforceability of patents against government agencies or government contractors. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Further, the standards applied by the USPTO and foreign patent offices in granting patents are not always applied uniformly or predictably. As such, we do not know the degree of future protection that we will have on our technologies and product candidate(s). While we will endeavor to try to protect our technologies and product candidate(s) with intellectual property rights such as patents, as appropriate, the process of obtaining patents is time-consuming, expensive, and unpredictable.

In addition, geopolitical actions in the United States and in other countries could increase the uncertainties and costs surrounding the prosecution or maintenance of our patent applications or those of any future licensors and the maintenance, enforcement, or defense of our issued patents or those of any future licensors. As a result, our competitive position may be impaired, and our business, financial condition, results of operations, and prospects may be adversely affected.

***Obtaining and maintaining our patent protection depends on compliance with various procedural requirements, document submissions, fee payment and other requirements imposed by governmental patent agencies. Our patent protection could be reduced or eliminated for non-compliance with these requirements.***

Periodic maintenance fees on any issued patent are due to be paid to the USPTO and other foreign patent agencies in several stages over the lifetime of the patent. We rely on our outside counsel or third-party vendors to pay these fees. The USPTO, CIPO and various foreign national or international patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While, in many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of patent rights include, but are not limited to, failure to timely file national and regional stage patent applications based on our international patent application, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If we or our licensors fail to maintain the patents and patent applications covering our present and future product candidates, our competitors might be able to enter the market, which would have an adverse effect on our business.

**Risks Related to our Business Operations** 

***We will be required to expand our development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.***

As our development and commercialization plans and strategies develop, and as we continue operating as a public company, we expect to need and to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of drug development, regulatory affairs and, if our product candidate receives marketing approval, sales, marketing and distribution. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial and human resources, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel, as the competition for individuals in oncology product development is high. Our future financial performance and our ability to commercialize our product candidates will depend, in part, on our ability to effectively manage any future growth, and the expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

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***Our future success depends on our ability to retain key members of senior management and to attract, retain and motivate qualified personnel.*** 

Our ability to compete in the highly competitive biopharmaceutical industry depends upon our ability to attract and retain highly qualified management, research and development, clinical, financial and business development personnel. Our senior management may terminate their employment with us at any time, and we do not maintain "key person" insurance for any of our employees.

The Acquisition resulted in a combined management team that is small relative to our development ambitions. We are heavily dependent on a limited number of individuals with specialized expertise in PI3K/AKT/mTOR pathway biology, metabolic oncology, and clinical development of combination products. The loss of one or more of these individuals, particularly during the critical post-Acquisition integration period, could significantly delay our clinical development programs. Competition for individuals with this specialized expertise is intense, and we may not be able to recruit suitable replacements on acceptable terms or in a timely manner.

Recruiting and retaining qualified scientific and clinical personnel and, if we progress the development of any of our product candidates, commercialization, manufacturing and sales and marketing personnel, will be critical to our success. The loss of the services of members of our senior management or other key employees could impede the achievement of our research, development and commercialization objectives and seriously harm our ability to successfully implement our business strategy. Furthermore, replacing members of our senior management and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval of and commercialize our product candidates. Our success also depends on our ability to continue to attract, retain and motivate highly skilled junior, mid-level and senior managers, as well as junior, mid-level and senior scientific and medical personnel. Competition to hire from this limited candidate pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to continue to attract and retain high-quality personnel, our ability to pursue our growth strategy will be limited.

***Following the Acquisition, certain of our employees who previously worked at a private company are now subject to public company compliance obligations, and any failure to comply with these obligations could expose us to regulatory risk and reputational harm.***

As a result of the Acquisition, a number of individuals who previously operated in a private company environment are now employees or officers of a publicly traded company and are subject to public company compliance obligations, including compliance with our insider trading policy, Section 16 reporting requirements under the Securities Exchange Act of 1934, Regulation FD restrictions on selective disclosure of material nonpublic information, and quiet period restrictions around SEC filings. These individuals may not have prior experience with public company compliance requirements.

We have implemented onboarding and training programs to educate former Faeth employees regarding these obligations. However, there can be no assurance that all individuals will fully understand or consistently comply with these requirements, particularly during the initial post-Acquisition integration period. Any inadvertent violation of insider trading laws, Section 16 reporting obligations, or Regulation FD could result in SEC enforcement action, personal liability for the individuals involved, and reputational harm to the company. Such violations could also undermine investor confidence in our corporate governance practices and adversely affect the trading price of our common stock.

***If we engage in future acquisitions or strategic collaborations, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities and subject us to other risks.*** 

From time to time, we may evaluate various acquisitions and strategic collaborations, including licensing or acquiring complementary products, intellectual property rights, technologies or businesses, as we may deem appropriate to carry out our business plan. Any potential acquisition or strategic collaboration may entail numerous risks, including:

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•increased operating expenses and cash requirements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the assumption of additional indebtedness or contingent liabilities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•assimilation of operations, intellectual property and products of an acquired company, including difficulties associated with integrating new personnel;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the diversion of our management's attention from our existing programs and initiatives in pursuing such a strategic partnership, merger or acquisition;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory approvals; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our inability to generate revenue from acquired technology sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.

Additionally, if we undertake future acquisitions, we may issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire intangible assets that could result in significant future amortization expenses. Moreover, we may not be able to locate suitable acquisition opportunities and this inability could impair our ability to grow or obtain access to technology or products that may be important to the development of our business.

***Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.*** 

We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk if we commercially sell any products that we may develop. If we cannot successfully defend ourselves against claims that our product candidates or products caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•reduced resources of our management to pursue our business strategy;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•decreased demand for any product candidates or products that we may develop;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•injury to our reputation and significant negative media attention;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•withdrawal of clinical trial participants;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•initiation of investigations by regulators;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•product recalls, withdrawals or labeling, marketing or promotional restrictions;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•significant costs to defend the resulting litigation;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•substantial monetary awards paid to clinical trial participants or patients;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•loss of revenue; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the inability to commercialize any products that we may develop.

We do not currently maintain product liability insurance because we have determined that the cost of available coverage is not justified relative to our current stage of clinical development. Once we are ready for a product launch, we intend to bind a policy with product liability insurance coverage in the aggregate and a per incident limit at an amount adequate to cover estimated liabilities that we may incur. We may need to increase our insurance coverage if we re-initiate our clinical trials or if we commence commercialization of our product candidates. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

**Risks Related to our Securities and our Status as a Public Company** 

***The trading price of our common stock may be volatile, and you could lose all or part of your investment.*** 

The trading price of our common stock is likely to be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control, including limited trading volume. The stock market in general and the market for biopharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, investors may not be able to sell their common stock at or above the price paid for the common stock. In addition to the factors discussed elsewhere in this "Risk Factors" section, these factors include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the commencement, enrollment or results of our clinical trials;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•positive or negative results from, or delays in, testing and clinical trials by us, collaborators or competitors;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the loss of any of our key scientific or management personnel;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•regulatory or legal developments in the United States and other countries;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the success of competitive products or technologies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•adverse actions taken by regulatory agencies with respect to our clinical trials or manufacturers;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•changes or developments in laws or regulations applicable to our product candidates and preclinical program;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•changes in the structure and scope of health care payment systems;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•changes to our relationships with collaborators, manufacturers or suppliers;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•concerns regarding the safety of our product candidates ;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•announcements concerning our competitors or the pharmaceutical industry in general;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•actual or anticipated fluctuations in our operating results;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•changes in financial estimates or recommendations by securities analysts;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•potential acquisitions, financing, collaborations or other corporate transactions;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the results of our efforts to discover, develop, acquire or in-license additional product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the trading volume of our common stock on Nasdaq;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•sales of our common stock by us, members of our senior management and directors or our stockholders or the anticipation that such sales may occur in the future;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•general economic, political, and market conditions and overall fluctuations in the financial markets in the United States;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•stock market price and volume fluctuations of comparable companies and, in particular, those that operate in the biopharmaceutical industry;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•investors' general perception of us and our business; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•other events and factors, many of which are beyond our control.

These and other market and industry factors may cause the market price and demand for our common stock to fluctuate substantially, regardless of our actual operating performance, which may limit or prevent investors from selling their common stock at or above the price paid for the common stock and may otherwise negatively affect the liquidity of our common stock. In addition, the stock market in general, and biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.

Some companies that have experienced volatility in the trading price of their shares have been the subject of securities class action litigation. From time to time, we have been, and may continue to be, subject to legal proceedings and claims in the ordinary course of business. We also may decide to settle lawsuits on unfavorable terms.

Any such negative outcome could result in payments of substantial damages or fines, damage to our reputation or adverse changes to our business practices. Defending against litigation is costly and time-consuming, and could divert our management's attention and our resources. Furthermore, during the course of litigation, there could be negative public announcements of the results of hearings, motions or other interim proceedings or developments, which could have a negative effect on the market price of our common stock.

***Our business and operations could be negatively affected by any securities litigation or stockholder activism, which could cause us to incur significant expense, hinder execution of business and growth strategies and impact our share price.***

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In the past, following periods of volatility in the market price of a company's securities, securities class action litigation has often been brought against that company. Stockholder activism, which could take many forms or arise in a variety of situations, has been increasing recently. Volatility in the stock price of our common stock or other securities or other reasons may in the future cause us to become the target of securities litigation or stockholder activism.

Securities litigation and stockholder activism, including proxy contests, could result in substantial costs and divert management's and the Board's attention and resources from our business. The potential of a proxy contest or other stockholder activism could interfere with our ability to execute on our strategic plan, give rise to perceived uncertainties as to our future direction, result in the loss of potential business opportunities or make it more difficult to attract and retain qualified personnel, any of which could materially and adversely affect our business and operating results. Further, our share price could be subject to significant fluctuation or otherwise be adversely affected by the events, risks and uncertainties of any securities litigation and stockholder activism.

***A significant portion of our total outstanding shares may be sold into the market, which could cause the market price of our common stock to drop significantly, even if our business is doing well.*** 

Sales of a substantial number of shares of our common stock in the public market could occur at any time. If our stockholders sell, or the market perceives that our stockholders intend to sell, substantial amounts of our shares of common stock in the public market, the market price of our common stock could decline significantly.

In addition, we have filed registration statements registering the issuance of all shares of common stock subject to options or other equity awards issued or reserved for future issuance under our equity incentive plans. Shares registered under these registration statements will be available for sale in the public market subject to vesting arrangements and exercise of options and, in the case of our affiliates, the restrictions of Rule 144 under the Securities Act.

Furthermore, certain holders of our common stock, or their transferees, have rights, subject to some conditions, to require us to file one or more registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders. If we were to register the resale of these shares, they could be freely sold in the public market. If these additional shares are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could decline.

Finally, in connection with the execution of the Agreement and Plan of Merger, or the Merger Agreement, dated as of February 17, 2026, by and among the Company, Sapphire First Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of the Company, Sapphire Second Merger Sub, LLC, a Delaware limited liability company and wholly owned subsidiary of the Company, Faeth Subsidiary and Faeth HoldCo, certain of our directors and officers, as well as certain of the directors, officers and stockholders of Faeth Therapeutics, each as of immediately prior to the Acquisition, entered into lock-up agreements, pursuant to which each such stockholder will be subject to a 180-day lockup on the sale or transfer of shares of our common stock and Series B Preferred Stock held by each such stockholder, including those shares received by directors and officers in the Acquisition, subject to certain limited exceptions as set forth in such lock-up agreements. Upon expiration of this 180-day lockup period, these shares will become eligible for sale in the public market. Pursuant to the Merger Agreement and the registration rights agreement that we entered into pursuant to the 2026 Private Placement, we are obligated to prepare and file a resale registration statement with the SEC to register the resale of shares of our common stock underlying the Series B Preferred Stock and warrant to purchase shares of Series B Preferred Stock. We will use commercially reasonable efforts to cause this registration statement to be declared effected by the SEC. Once the registration statement is declared effective, the shares subject to the registration statement will no longer constitute restricted securities and may be sold freely in the public markets, subject to (i) the approval of the Company Stockholder Matters (as defined below), (ii) the approval of the Nasdaq Listing Application (as defined below) and (iii) any beneficial ownership limitations set by the holder of Series B Preferred Stock. If our stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after legal restrictions on resale lapse, the trading price of our common stock could decline.

***If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud.***

Effective internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, are designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their implementation, could cause us to

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fail to meet our reporting obligations. In addition, any testing by us conducted in connection with Section 404 of the Sarbanes-Oxley Act, or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement. Ineffective internal controls could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our common stock.

***We are an "emerging growth company" and a "smaller reporting company," and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our shares of common stock less attractive to investors.***

We are an "emerging growth company," as defined in Section 2(a) of the Securities Act. For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including the auditor attestation requirements in the assessment of our internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act, compliance with any new requirements adopted by the PCAOB, disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and the requirements of holding advisory "say-on-pay" votes on executive compensation and stockholder advisory votes on golden parachute compensation not previously approved. Certain of these reduced reporting requirements and exemptions are also available to us due to the fact that we qualify as a "smaller reporting company" under SEC rules. For instance, smaller reporting companies are not required to obtain an auditor attestation and report regarding management's assessment of internal control over financial reporting, are not required to provide a compensation discussion and analysis, are not required to provide a pay-for-performance graph or CEO pay ratio disclosure and may present only two years of audited financial statements and related MD&A disclosure.

Under the JOBS Act, we will remain an emerging growth company until the earliest of (1) the last day of the fiscal year in which we have more than $1.235 billion in annual revenue; (2) the date we qualify as a "large accelerated filer," with at least $700.0 million of equity securities held by non-affiliates; (3) the issuance, in any three-year period, by our company of more than $1.0 billion in non-convertible debt securities; and (4) December 31, 2026, which is the last day of the fiscal year following the fifth anniversary of the date of the first sale of our common stock pursuant to an effective registration statement filed under the Securities Act. Under current SEC rules, however, we will continue to qualify as a "smaller reporting company" for so long as (i) we have a public float (i.e., the market value of common equity held by non-affiliates) of less than $250 million or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our common stock held by non-affiliates is less than $700 million.

We cannot predict if investors will find our shares of common stock to be less attractive because we may rely on these exemptions. If some investors find our shares of common stock less attractive as a result, there may be a less active trading market for our shares of common stock, and our share price may be more volatile.

Under the JOBS Act, emerging growth companies also can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have elected not to "opt out" of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised 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. Therefore, the reported results of operations contained in our consolidated financial statements may not be directly comparable to those of other public companies.

***We do not anticipate paying any cash dividends on our common stock in the foreseeable future.*** 

We do not intend to pay any cash dividends on our common stock in the foreseeable future and we currently intend to retain our future earnings, if any, to fund the development and growth of our business. Therefore, you should not rely on an investment in our common stock to provide dividend income. Our board of directors has complete discretion as to whether to distribute dividends. Even if our board of directors decides to declare and pay dividends, the timing, amount and form of future dividends, if any, will depend on, among other things, our future results of operations and cash flow, our capital requirements and surplus, the amount of distributions, if any, received by us from our subsidiaries, our financial condition, contractual restrictions and other factors deemed

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relevant by our board of directors. As a result, capital appreciation, if any, on our common stock will be your sole source of gains for the foreseeable future.

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

We are subject to federal, state and local income and other taxes in the United States and in foreign jurisdictions because of the scope of our operations. New tax laws, statutes, rules, regulations or ordinances could be enacted at any time. Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted differently, changed, repealed or modified at any time. Any such enactment, interpretation, change, repeal or modification could adversely affect us, possibly with retroactive effect. For example, the U.S. government recently enacted legislation commonly referred to as the One Big Beautiful Bill Act that (along with prior U.S. federal tax reform legislation) has resulted in significant changes to the taxation of business entities, including, among other changes, the imposition of minimum taxes and excise taxes, changes to the taxation of income derived from international operations, changes in the deduction and amortization of research and development expenditures, and limitations on the deductibility of business interest. Future guidance from the Internal Revenue Service and other taxing authorities with respect to this and other legislation may affect us, and certain aspects of such legislation could be repealed or modified in future legislation or sunset in future years. In addition, it is uncertain if and to what extent various states will conform to federal law. We continue to evaluate the impact that these and other tax reforms may have on our business. To the extent that any such changes in tax laws and regulations have a negative impact on us, including as a result of related uncertainty, our business, financial condition, results of operations and cash flows may be materially and adversely impacted and we may be required to implement changes to minimize increases in our tax liability.

***Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations.*** 

Our net operating loss, or NOL, carryforwards could expire unused and be unavailable to offset future income tax liabilities because of their limited duration or because of restrictions under U.S. tax law. U.S. federal NOLs generated in taxable years beginning before January 1, 2018 are permitted to be carried forward for only 20 taxable years under applicable U.S. federal income tax law. Under the Tax Cuts and Jobs Act of 2017, or the Tax Act, as modified by the Coronavirus Aid, Relief, and Economic Security Act, or the CARES Act, NOLs arising in taxable years beginning after December 31, 2017 may be carried forward indefinitely, but the deductibility of such NOLs generally will be limited in taxable years beginning after December 31, 2020 to 80% of current year taxable income. As of December 31, 2025, we had NOL carryforwards for federal and state income tax purposes of approximately $170.5 million and $98.9 million, respectively, a portion of which expired beginning in 2025. Net operating loss carryforwards generated after December 31, 2017 for federal tax reporting purposes of $137.2 million have an indefinite life. The remaining federal net operating losses are subject to a 20-year carryforward period.

In general, under Section 382 of the Internal Revenue Code of 1986, as amended, or the Code, a corporation that undergoes an "ownership change" (as defined under Section 382 of the Code and applicable Treasury Regulations) is subject to limitations on its ability to utilize its pre-change NOLs to offset future taxable income. Following the approval of the Company Stockholder Matters, the Acquisition will result in an ownership change for us and, accordingly, our NOL carryforwards and certain other tax attributes will be subject to limitations (or disallowance) on their use after approval of the Company Stockholder Matters. Faeth's NOL carryforwards may also be subject to limitations as a result of prior shifts in equity ownership and/or the Acquisition. We may also have experienced an ownership change in the past, and may experience ownership changes in the future as a result of subsequent shifts in our stock ownership, some of which are outside our control. Furthermore, our ability to utilize NOLs of Faeth we have acquired as a result of the Acquisition may be subject to limitations. There is also a risk that due to regulatory changes, such as suspensions on the use of NOLs or other unforeseen reasons, our existing NOLs could expire or otherwise be unavailable to reduce future income tax liabilities, including for state tax purposes. For these reasons, we may not be able to utilize a material portion of the NOLs reflected on our balance sheet, even if we attain profitability, which could potentially result in increased future tax liability to us and could adversely affect our operating results and financial condition.

***We have incurred and expect to continue incurring significantly increased costs as a result of operating as a company whose common stock is publicly traded, and our management will be required to devote substantial time to new compliance initiatives.***

As a public company, we have incurred significant legal, accounting and other expenses that we did not incur previously, as a private company. These expenses will likely be even more significant after we no longer qualify as

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an emerging growth company. The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of Nasdaq and other applicable securities rules and regulations impose various requirements on public companies in the United States, including the establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our senior management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance, which in turn could make it more difficult for us to attract and retain qualified senior management personnel or members for our board of directors.

However, these rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

Pursuant to Section 404, we are required to furnish a report by our senior management on our internal control over financial reporting. Depending upon our filer status, we could also be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm as required by Section 404(b). To prepare for eventual compliance with Section 404, we will be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is a risk that we will not be able to conclude, within the prescribed timeframe or at all, that our internal control over financial reporting is effective as required by Section 404.

***Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and, to the extent enforceable, the federal district courts of the United States of America, will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders' ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.*** 

Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and, to the extent enforceable, the federal district courts of the United States of America, will be the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•any derivative claim or cause of action brought on our behalf;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•any claim or cause of action for breach of a fiduciary duty owed by any of our current or former directors, officers or other employees to us or our stockholders;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•any claim or cause of action against us or any of our current or former directors, officers or other employees, arising out of or pursuant to any provision of the Delaware General Corporation Law, or DGCL, our certificate of incorporation or our bylaws;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•any claim or cause of action seeking to interpret, apply, enforce or determine the validity of our certificate of incorporation or our bylaws;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•any action or proceeding as to which the DGCL confers jurisdiction to the Court of Chancery of the State of Delaware; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•any claim or cause of action against us or any of our current or former directors, officers or other employees that is governed by the internal-affairs doctrine, in all cases to the fullest extent permitted by law and subject to the court having personal jurisdiction over the indispensable parties named as defendants.

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These exclusive-forum provisions may limit a stockholder's ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers, or other employees, which may discourage lawsuits against us and our directors, officers, and other employees. If any other court of competent jurisdiction were to find either exclusive-forum provision in our amended and restated certificate of incorporation to be inapplicable or unenforceable, we may incur additional costs associated with resolving the dispute in other jurisdictions, which could seriously harm our business.

***Insiders have substantial influence over us and could cause us to take actions that may not be, or refrain from taking actions that may be, in our best interest or in the best interest of our stockholders.***

We believe that our directors, executive officers and principal stockholders, together with their affiliates, own, in the aggregate, a substantial portion of our outstanding common stock. As a result, if these or certain of these stockholders were to choose to act together, they may be able to affect the outcome of matters submitted to our stockholders for approval, as well as our management and affairs, such as:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the composition of our board of directors;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the adoption of amendments to our certificate of incorporation and bylaws;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the approval of mergers or sales of substantially all of our assets;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our capital structure and financing; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the approval of contracts between us and these stockholders or their affiliates, which could involve conflicts of interest.

This concentration of ownership could harm the market price of our common stock by:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•delaying, deferring or preventing a change in control of our company and making some transactions more difficult or impossible without the support of these stockholders, even if such transactions are beneficial to other stockholders;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•impeding a merger, consolidation, takeover or other business combination involving our company; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•requiring us to engage in transactions that may not be agreeable to or in the best interest of us or other stockholders.

**Risks Related to the Acquisition**

***Pursuant to the terms of the Acquisition, we are required to recommend that our stockholders approve the conversion of all outstanding shares of our Series B preferred stock into shares of our common stock. We must also obtain stockholder approval of an amendment to our certificate of incorporation to increase the number of shares we are authorized to issue. We cannot guarantee that our stockholders will approve these matters, and if they fail to do so we may be required to settle such shares in cash and our operations may be materially harmed.***

Under the terms of the Merger Agreement and the 2026 Private Placement purchase agreement, as promptly as practicable following the date of the Merger Agreement and pursuant to the Nasdaq Stock Market Rules, we will call and hold a meeting of our stockholders to obtain the requisite approval from our legacy stockholders for, among other things, (i) the approval, in accordance with certain of the rules of Nasdaq of the conversion of the Series B Preferred Stock into shares of our common stock, or the Conversion Proposal, (ii) the approval of a "change of control" under Nasdaq Listing Rules 5110 and 5635(b), or the Change in Control Proposal, (iii) the amendment of our certificate of incorporation to authorize an increase of up to 300,000,000 shares of our common stock, or the Charter Amendment Proposal and, together with the Conversion Proposal and the Change in Control Proposal, the Company Stockholder Matters, (iv) the approval of (A) the 2026 Equity Incentive Plan, which will provide for new awards for a number of shares of our common stock not exceeding 10% of our fully diluted shares of capital stock outstanding immediately after the 2026 Private Placement, and subject to approval by our Board, and which will include an annual increase pursuant to an "evergreen" provision providing for an annual increase of up to 5% of the total number of our fully diluted shares of capital stock outstanding as of the day prior to such increase and (B) the 2026 Employee Stock Purchase Plan, with a total pool of shares of our common stock not exceeding 1% of our fully

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diluted shares of capital stock outstanding immediately after the 2026 Private Placement, and which shall include an annual increase pursuant to an "evergreen" provision providing for an annual increase of up to 1% of the total number of our fully diluted shares of capital stock outstanding as of the day prior to such increase. If we fail to receive sufficient proxies to constitute a quorum or to obtain the required vote on the Company Stockholder Matters and/or our Nasdaq Listing Application is not approved, we would be required to adjourn the meeting one or more times for up to 30 days per adjournment. If stockholder approval of the Company Stockholder Matters or approval of the Nasdaq Listing Application are still not obtained following such adjournment(s), we will be obligated to continue soliciting stockholder approval at subsequent annual or special meetings of our stockholders, held at intervals of no more than six months, until such approvals are obtained, which would be time consuming and costly.

There can be no assurance that our legacy stockholders will approve the Company Stockholder Matters. If our legacy stockholders do not approve the Charter Amendment Proposal, we would be unable to issue the additional shares of our common stock necessary to complete the conversion of Series B Preferred Stock into our common stock, and may be unable to satisfy our other capital needs, which could have a material adverse effect on our business, financial condition, and prospects.

Additionally, if the Company Stockholder Matters are not approved by the date that is six months following the initial issuance date of the Series B Preferred Stock, the holders of the Series B Preferred Stock would be entitled to require us to settle their shares of our common stock underlying the Series B Preferred Stock for cash at a price per share equal to the fair value of our common stock at such time as described in the Certificate of Designation or Preferences, Rights and Limitations of the Series B Preferred Stock, or the Certificate of Designation. If we are forced to cash settle a significant amount of the shares of our common stock underlying the Series B Preferred Stock, it could materially affect our results of operations, business and financial condition.

***Failure to obtain approval of the Nasdaq Listing Application could materially affect our results of operations, business and financial condition.***

Pursuant to the Merger Agreement, in order to permit the waiver of the beneficial ownership limitations applicable to the Series B Preferred Stock and take other actions following the consummation of the Acquisition, which would constitute a "change of control" under Nasdaq Listing Rule 5110(a), we are required to use our reasonable best efforts to file an initial listing application for our common stock on Nasdaq (the "Nasdaq Listing Application"). The Nasdaq Listing Application must be conditionally approved prior to the date of our stockholder meeting to approve the Company Stockholder Matters. If we fail to meet the Nasdaq listing requirements and Nasdaq does not approve the Nasdaq Listing Application, we will be required to adjourn our stockholder meeting to approve the Company Stockholder Matters one or more times for up to 30 days per adjournment, continue to use our reasonable best efforts to obtain approval of the Nasdaq Listing Application and to continue soliciting stockholder approval of the Company Stockholder Matters at subsequent annual or special meetings of our stockholders, held at intervals of no more than six months, until such approval and the approval of the Company Stockholder Matters are obtained, which would be time consuming and costly. Additionally, if the Company Stockholder Matters are not approved by the date that is six months following the initial issuance date of the Series B Preferred Stock, the holders of the Series B Preferred Stock would be entitled to require us to settle their shares of Series B Preferred Stock for cash at a price per share equal to the fair value of the Series B Preferred Stock at such time as described in the Certificate of Designation or Preferences, Rights and Limitations of the Series B Preferred Stock. If we are forced to cash settle a significant amount of the shares of our common stock underlying the Series B Preferred Stock, it could materially affect our results of operations, business and financial condition. We cannot assure you that we will be able to meet Nasdaq's initial listing standards. Furthermore, if we fail to obtain approval of the Nasdaq Listing Application, we may be unable to execute on our plans for the Company following the Acquisition, which could materially affect our results of operations, business and financial condition.

***There is no guarantee that the Acquisition will increase stockholder value.***

In February 2026, we consummated the Acquisition, pursuant to which we acquired Faeth, and we closed the 2026 Private Placement. We cannot guarantee that implementing the Acquisition and related transactions will not impair stockholder value or otherwise adversely affect our business. The Acquisition poses significant integration challenges between our businesses and employees which could result in management and business disruptions, any

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of which could harm our results of operation, business prospects, and impair the value of the Acquisition to our stockholders.

***The failure to successfully integrate the businesses of the Company and Faeth Therapeutics in the expected timeframe could adversely affect our results of operations, financial condition, and future results.***

Our ability to successfully integrate the operations of the Company and Faeth Therapeutics will depend, in part, on our ability to realize the anticipated benefits from the Acquisition. If we are not able to achieve these objectives within the anticipated time frame, or at all, the anticipated benefits of the Acquisition may not be realized fully, or at all, or may take longer to realize than expected, and the value of our common stock may be adversely affected. In addition, the integration of the Company's and Faeth's respective businesses will be a time-consuming and expensive process. Proper planning and effective and timely implementation will be critical to avoid any significant disruption to our operations. There can be no assurance that we will effectively manage the increased complexity of our business without experiencing operating inefficiencies or control deficiencies. Delays encountered in the integration process could have a material adverse effect on our expenses, operating results and financial condition, including the value of shares of our common stock.

***We expect to incur substantial expenses related to the integration of Faeth.***

We have incurred, and expect to continue to incur, substantial expenses in connection with the Acquisition and the integration of Faeth. There are a large number of processes, policies, procedures, operations, technologies and systems that must be integrated, including accounting and finance, billing, payroll, and benefits. Both the Company and Faeth have incurred significant transaction expenses in connection with the drafting and negotiation of the Merger Agreement, and the related ancillary agreements. While we have assumed that a certain level of expenses will be incurred, there are many factors beyond our control that could affect the total amount or the timing of the integration expenses. Moreover, many of the expenses that will be incurred are, by their nature, difficult to estimate accurately. These integration expenses likely will result in our taking significant charges against earnings following the completion of the Acquisition, and the amount and timing of such charges are uncertain at present.

**General Risk Factors** 

***Our business, operations and clinical development plans and timelines, as well as the manufacturing, clinical trial and other business activities performed by us or by third parties with whom we conduct business, including our contract manufacturers, CROs, shippers, equipment suppliers and others, could be adversely affected by the effects of health epidemics.***

Our business could be adversely affected by health epidemics wherever we have clinical trial sites or other business operations. In addition, health epidemics could cause significant disruption in the operations of third-party manufacturers, CROs and other third parties upon whom we rely. The effects of government orders may negatively impact productivity, disrupt our business and delay our clinical programs and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course.

If our relationships with our suppliers or other vendors are terminated or scaled back as a result of health epidemics, we may not be able to enter into arrangements with alternative suppliers or vendors or do so on commercially reasonable terms or in a timely manner. Switching or adding additional suppliers or vendors involves substantial cost and requires management time and focus. In addition, there is a natural transition period when a new supplier or vendor commences work. As a result, delays may occur, which could adversely impact our ability to meet our desired clinical development and any future commercialization timelines. Although we carefully manage our relationships with our suppliers and vendors, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not harm our business.

In addition, our preclinical studies and clinical trials may be affected by health epidemics. Clinical site initiation, patient enrollment and activities that require visits to clinical sites, including data monitoring, may be delayed due to prioritization of hospital resources toward the pandemic or concerns among patients about participating in clinical trials during a pandemic. Some patients may have difficulty following certain aspects of clinical trial protocols if quarantines impede patient movement or interrupt healthcare services. These challenges may also increase the costs of completing our clinical trials. Similarly, if we are unable to successfully recruit and

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retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure or experience additional restrictions by their institutions, city or state, our clinical trial operations could be adversely impacted.

***If our information systems or data, or those of our collaborators, contractors, consultants or other third parties with whom we work, are or were compromised, we could experience adverse consequences, including but not limited to regulatory investigations or actions; litigation; fines and penalties; significant disruption of our product development programs and our ability to operate our business effectively; reputational harm; and other adverse consequences.*** 

In the ordinary course of our business, we and the third parties with whom we work, process, collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share, or, collectively, process, proprietary, confidential, and sensitive data, including personal data, intellectual property, trade secrets and clinical trial data, or, collectively, sensitive information.

Cyber-attacks, malicious internet-based activity, online and offline fraud, and other similar activities threaten the confidentiality, integrity, and availability of our sensitive information and information technology systems, and those of the third parties with whom we work. Such threats are prevalent and continue to rise, are increasingly difficult to detect, and come from a variety of sources, including traditional computer "hackers," threat actors, "hacktivists," organized criminal threat actors, personnel (such as through theft or misuse), sophisticated nation states, and nation-state-supported actors. Some threat actors now engage and are expected to continue to engage in cyber-attacks, including without limitation nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities. During times of war and other major conflicts, we, the third parties with whom we work may be vulnerable to a heightened risk of these attacks, including retaliatory cyber-attacks, that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our goods and services.

We and the third parties with whom we work are subject to a variety of evolving threats, including but not limited to computer viruses, malicious or unintentional actions or inactions that cause vulnerabilities, malware, software or hardware failure, supply chain attacks, social engineering (including through deep fakes, which may be increasingly more difficult to identify as fake, and phishing), credential stuffing, ransomware, unauthorized access, attacks enhanced or facilitated by artificial intelligence, or AI, natural disasters, terrorism, war and telecommunication and electrical failures. In particular, ransomware attacks, including those perpetrated by organized criminal threat actors, nation-states, and nation-state-supported actors, are becoming increasingly prevalent and severe, and can lead to significant interruptions in our operations, loss of data and income, reputational harm, and diversion of funds. Extortion payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such payments due to, for example, applicable laws or regulations prohibiting such payments.

It may be difficult and/or costly to detect, investigate, mitigate, contain, and remediate a security incident. Our efforts to do so may not be successful. Actions taken by us or the third parties with whom we work to detect, investigate, mitigate, contain, and remediate a security incident could result in outages, data losses, and disruptions of our business. Threat actors may also gain access to other networks and systems after a compromise of our networks and systems. For example, threat actors may use an initial compromise of one part of our environment to gain access to other parts of our environment, or leverage a compromise of our networks or systems to gain access to the networks or systems of third parties with whom we work, such as through phishing or supply chain attacks.

Future or past business transactions (such as acquisitions or mergers) expose us to additional cybersecurity risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities' systems and technologies. Furthermore, we may discover security issues that were not found during due diligence of such acquired or integrated entities, and it may be difficult to integrate companies into our information technology environment and security program.

In addition, our reliance on third-party service providers could introduce new cybersecurity risks and vulnerabilities, and other threats to our business operations. For example, we rely on third parties to operate critical business systems and process sensitive data in a variety of contexts, including, without limitation, cloud-based infrastructure, data center facilities, encryption and authentication technology, personnel email, and other functions. We also rely on third parties, including CROs, clinical trial sites and clinical trial vendors, to collect, store, and transmit sensitive data as part of our research activities. Our ability to monitor these third parties is limited, and

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these third parties may not have adequate information security measures. If our third-party service providers experience a security incident or other interruption, we could experience adverse consequences. While we may be entitled to damages if our third-party service providers fail to satisfy their privacy or security-related obligations to us, any award may be insufficient to cover damages, or we may be unable to recover such awards. Supply-chain attacks have also increased in frequency and severity, and we cannot guarantee that third parties' infrastructure in our supply chain or our third-party partners' supply chains have not been compromised.

Remote work has increased risks to our information systems and data, as personnel utilize network connections, computers and devices outside of our premises or network.

While we have implemented security measures designed to protect against security incidents, there can be no assurance that these measures will be effective. We take steps designed to detect, mitigate, and remediate vulnerabilities in our information systems (such as our hardware and/or software, including that of third parties with whom we work). We have not and may not in the future, however, detect and remediate all such vulnerabilities, including on a timely basis. Further, we have and may in the future experience delays in developing and deploying remedial measures and patches designed to address identified vulnerabilities. Vulnerabilities could be exploited and result in a security incident.

Any of the previously identified or similar threats have in the past and may in the future cause a security incident or other interruption that have in the past and may in the future result in unauthorized, unlawful, or accidental acquisition, modification, destruction, loss, alteration, encryption, disclosure of, or access to our sensitive information or our information technology systems, or those of the third parties with whom we work. A security incident or other interruption could disrupt our ability (and that of third parties with whom we work) to operate our business.

We have in the past and may in the future expend significant resources or modify our business activities (including our clinical trial activities) in an effort to protect against security incidents, particularly where required by applicable data privacy and security laws or regulations or industry standards. Certain data privacy and security obligations require us to implement and maintain certain security measures.

Applicable data privacy and security obligations may require us, or we may voluntarily choose, to notify relevant stakeholders, including affected individuals, customers, regulators, and investors, of security incidents, or to take other actions, such as providing credit monitoring and identity theft protection services. Such disclosures and related actions can be costly, and the disclosure or the failure to comply with such applicable requirements could lead to adverse consequences.

If we (or a third party with whom we work) experience a security incident or are perceived to have experienced a security incident, this could result in a disruption of our development programs and our business operations, whether due to a loss of our trade secrets or other proprietary information, significant delays or setbacks in our research, or other similar disruptions. For example, the loss of clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Such an actual or perceived security incident could also cause us to experience other adverse consequences, such as: loss of, or damage to, our data or applications, inappropriate disclosure of confidential or proprietary information, legal liability, exposure to litigation (including class claims) and regulatory enforcement action (for example, investigations, fines, penalties, audits and inspections), additional reporting requirements and/or oversight, fines, penalties, indemnification obligations, harm to our competitive position, reputational damage, and delay in the further development and commercialization of our product candidates.

Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations. Additionally, we cannot be certain that our insurance coverage will be adequate for data security liabilities actually incurred, will continue to be available to us on economically and commercially reasonable terms, or at all, or that any insurer will not deny coverage as to any future claim.

In addition to experiencing a security incident, third parties may gather, collect, or infer sensitive information about us from public sources, data brokers, or other means that reveal competitively sensitive details about the company and could be used to undermine our competitive advantage or market position. Additionally, sensitive information of ours could be leaked, disclosed, or revealed as a result of or in connection with our employees', personnel's, or vendors' use of generative AI technologies.

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***We and the third parties with whom we work are subject to rapidly changing and increasingly stringent U.S. and foreign laws, regulations, and rules; contractual obligations; industry standards; policies and other obligations relating to privacy, data protection and information security. Our actual or perceived failure (or that of the third parties with whom we work) to comply with these obligations could lead to regulatory investigations or actions; litigation (including class claims) and mass arbitration demands; fines and penalties; disruptions of business operations; reputational harm; loss of revenue or profits; and other adverse business consequences.*** 

In the ordinary course of business, we process personal data and other sensitive information. Our data processing activities subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations relating to data privacy and security.

In the United States, federal, state and local governments have enacted numerous privacy and data security laws, including federal and state health information privacy laws, federal and state security breach notification laws, federal and state consumer protection laws, and other similar laws (e.g., wiretapping laws). For example, at the federal level, HIPAA, as amended by HITECH, imposes specific requirements relating to the privacy, security and transmission of individually identifiable health information. Additionally, many states have enacted comprehensive privacy laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording residents with certain rights concerning their personal data. As applicable, such rights may include the right to access, correct, or delete certain personal data, and to opt-out of certain data processing activities, such as targeted advertising, profiling, and automated decision-making. The exercise of these rights may impact our business and ability to provide our products and services if we become subject to these laws. Certain states also impose stricter requirements for processing certain personal data, including sensitive information, such as conducting data privacy impact assessments. These state laws allow for statutory fines for noncompliance. For example, the California Consumer Privacy Act ("CCPA") applies to personal data of consumers, business representatives, and employees who are California residents and requires businesses subject to the CCPA to provide specific disclosures in privacy notices and respond to requests of such individuals to exercise certain rights concerning their personal data. The CCPA provides fines for noncompliance and a limited private right of action in connection with certain data breaches. While the CCPA and other U.S. state comprehensive consumer privacy laws exempt certain personal data processed in connection with clinical trials, these developments could further complicate compliance efforts, and increase legal risk and compliance costs for us and the third parties with whom we work should we become subject to these laws. Similar laws have been passed or are being considered in several other states, as well as at the federal and local levels, and we expect more governments to pass similar laws in the future. The evolving patchwork of local, state and federal privacy and data security laws increases the cost and complexity of operating our business and increases our exposure to liability, including from third party litigation and regulatory investigations, enforcement, fines, and penalties.

Outside the United States, an increasing number of laws, regulations, and industry standards govern data privacy and security. For example, the European Union's General Data Protection Regulation ("EU GDPR") the United Kingdom's General Data Protection Regulation ("UK GDPR") (collectively, "GDPR"), Brazil's General Data Protection Law (Lei Geral de Proteção de Dados Pessoais, or "LGPD") (Law No. 13,709/2018), and India's Information Technology Act and supplementary rules, impose strict requirements for processing personal data. The EU GDPR governs the collection, use, disclosure, transfer or other processing of personal data of European Economic Area ("EEA") residents. Among other things, the EU GDPR imposes requirements regarding the security of personal data and notification of data processing obligations to the competent national data processing authorities, changes the lawful bases on which personal data can be processed, expands the definition of personal data over prior EU law and requires changes to informed consent practices, as well as more detailed notices for clinical trial subjects and investigators. The EU GDPR also provides for substantial fines for breaches and violations (up to the greater of €20 million or 4% of annual global revenue). The EU GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies and obtain compensation for damages resulting from violations of the EU GDPR.

We increasingly use artificial intelligence and machine learning tools across our operations and business functions, and we expect our use of such tools to expand over time. While we believe that the responsible use of AI tools can enhance our operational efficiency, these tools present risks that could adversely affect our business. AI-generated outputs may be inaccurate, incomplete, or misleading, and reliance on such outputs without adequate human oversight could result in errors in regulatory submissions, clinical or scientific analyses, contractual provisions, or public disclosures. In addition, the input of proprietary, confidential, or sensitive information into

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third-party AI platforms could result in the inadvertent disclosure of trade secrets, attorney-client privileged materials, or material nonpublic information. The regulatory landscape governing the use of AI in the life sciences and pharmaceutical industries is rapidly evolving, and new laws, regulations, or guidance — including those arising from the current administration's policy initiatives — could impose additional compliance obligations, restrict certain uses of AI tools, or increase our exposure to regulatory enforcement actions or litigation. Any failure to adequately govern our use of AI tools could result in reputational harm, regulatory scrutiny, or legal liability. In the ordinary course of business, we transfer personal data from Europe and other jurisdictions to the United States or other countries. Europe and other jurisdictions have enacted laws requiring data to be localized or limiting the transfer of personal data to other countries. In particular, the EEA and the UK have significantly restricted the transfer of personal data to the United States and other countries whose privacy laws it generally believes are inadequate. Other jurisdictions may adopt or have already adopted similarly stringent data localization and cross-border data transfer laws. Although there are currently various mechanisms that may be used to transfer personal data from the EEA and UK to the United States in compliance with law, such as the EEA standard contractual clauses, the UK's International Data Transfer Agreement / Addendum, and the EU-U.S. Data Privacy Framework and the UK extension thereto (which allows for transfers to relevant U.S.-based organizations who self-certify compliance and participate in the Framework), these mechanisms are subject to legal challenges, and there is no assurance that we can satisfy or rely on these measures to lawfully transfer personal data to the United States. If there is no lawful manner for us to transfer personal data from the EEA, the UK or other jurisdictions to the United States, or if the requirements for a legally-compliant transfer are too onerous, we could face significant adverse consequences, including the interruption or degradation of our operations, the need to relocate part of or all of our business or data processing activities to other jurisdictions (such as Europe) at significant expense, increased exposure to regulatory actions, substantial fines and penalties, the inability to transfer data and work with partners, vendors and other third parties, and injunctions against our processing or transferring of personal data necessary to operate our business. Additionally, companies that transfer personal data out of the EEA and UK to other jurisdictions, particularly to the United States, are subject to increased scrutiny from regulators, individual litigants, and activist groups. Some European regulators have ordered certain companies to suspend or permanently cease certain transfers out of Europe for allegedly violating the GDPR's cross-border data transfer limitations.

Additionally, the U.S. Department of Justice issued a rule entitled Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons, which places additional restrictions on certain data transactions involving countries of concern (e.g., China, Russia, Iran) and covered persons (i.e., individuals and entities who are designated as such by the U.S. Attorney General or are considered "foreign persons" and majority owned by, organized under the laws of, primarily resident in, or a contractor of a covered person or country of concern, as applicable) that impacts certain business activities such as vendor engagements, sale or sharing of data, employment of certain individuals, and investor agreements. Violations of the rule could lead to significant civil and criminal fines and penalties. The rule applies regardless of whether data is anonymized, key-coded, pseudonymized, de-identified or encrypted, which presents particular challenges for companies like ours and may impact our ability to transfer data in connection with certain transactions or agreements.

In addition to data privacy and security laws, we are and may in the future become bound by contractual obligations and industry standards related to data privacy and security, and our efforts to comply with such obligations may not be successful. We publish privacy policies and other statements regarding data privacy and security. Regulators are increasingly scrutinizing these statements, and if these statements are found to be deficient, lacking in transparency, deceptive, unfair, misleading or misrepresentative of our practices, we may be subject to investigation, enforcement actions by regulators or other adverse consequences.

Obligations related to data privacy and security (and consumers' data privacy obligations) are quickly changing, becoming increasingly stringent, and creating uncertainty. These obligations may be subject to differing applications and interpretations, which may be inconsistent or in conflict among jurisdictions. Monitoring, preparing for and complying with these obligations requires us to devote significant resources (including, without limitation, financial and time-related resources). These obligations have in the past and may in the future necessitate changes to our information technologies, systems and practices and to those of any third parties that process personal data on our behalf. In addition, these obligations may require us to change aspects of our business model or our clinical trials.

Although we endeavor to comply with applicable data privacy and security obligations, we may at times fail (or be perceived to have failed) to do so. Moreover, despite our efforts, our personnel or third parties upon whom we

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rely may fail to comply with such obligations, which could negatively impact our business operations. If we (or third parties with whom we work) fail, or are perceived to have failed, to address or comply with data privacy, protection and security obligations, we could face significant consequences, including (without limitation): government enforcement actions (e.g., investigations, fines, penalties, audits, inspections and similar); litigation (including class claims) and mass arbitration demands; additional reporting requirements and/or oversight; bans or restrictions on processing personal data; orders to destroy or not use personal data; and/or imprisonment of company officials. In particular, plaintiffs have become increasingly active in bringing privacy-related claims against companies, including class claims and mass arbitration demands. Some of these claims allow for the recovery of statutory damages on a per violation basis, and, if viable, carry the potential for monumental statutory damages, depending on the volume of data and the number of violations. Any of these events could have a material adverse effect on our reputation, business, or financial condition, including but not limited to: interruptions or stoppages in our business operations (including our clinical trials); inability to process personal data or to operate in certain jurisdictions; limited ability to develop or commercialize our products; expenditure of time and resources to defend any claim or inquiry; adverse publicity; or substantial changes to our business model or operations.

***Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.*** 

Our operations, and those of our vendors and suppliers, could be subject to power shortages, telecommunications failures, water shortages, civil unrest, labor disputes, violence, earthquakes, floods, hurricanes, typhoons, fires, extreme weather conditions, infectious disease, medical epidemics and other natural or man-made disasters or business interruptions, for which we are predominantly self-insured. The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costs and expenses. We currently rely on third-party suppliers to produce and process our product candidates on a patient-by-patient basis. Our ability to obtain clinical supplies of our product candidates could be disrupted if the operations of these suppliers are affected by a man-made or natural disaster or other business interruption.

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

The trading market for our common stock will be influenced by the research and reports that equity research analysts publish about us and our business. As a public company, we have only limited research coverage by equity research analysts. Equity research analysts may elect not to initiate or continue to provide research coverage of our common stock, and such lack of research coverage may adversely affect the market price of our common stock. Even if we continue to have equity research analyst coverage, we will not have any control over the analysts or the content and opinions included in their reports. The price of our common stock could decline if one or more equity research analysts downgrade our common stock or issue other unfavorable commentary or research about us. If one or more equity research analysts ceases coverage of us or fails to publish reports on us regularly, demand for our common stock could decrease, which in turn could cause the trading price or trading volume of our common stock to decline.

**Item 1B. Unresolved Staff Comments.** 

Not applicable.

**Item 1C. Cybersecurity.** 

***Risk Management and Strategy***

We have established policies and processes designed for assessing, identifying, and managing material risk from cybersecurity threats to our critical computer networks, third party hosted services, communications systems, hardware and software, and our critical data, including clinical trial data, intellectual property, confidential information that is proprietary, strategic, financial or competitive in nature, and personal data.

Our legal team as well as the Vice Presidents of Product and Engineering are responsible for identifying, assessing and managing the Company's cybersecurity threats and risks. These functions use various methods such as automated tools, reports of threats and threat actors, third-party threat assessments, and vulnerability assessments in an effort to identify, monitor and assess cybersecurity threats.

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Depending on the environment, system and data, we implement and maintain various technical, physical, and organizational measures, processes, standards and policies designed to manage and mitigate material risks from cybersecurity threats, including, for example, cybersecurity testing and cybersecurity awareness training, encryption of certain data, network security controls, data segregation, access controls, asset management processes, and systems monitoring tools.

We retain third-party service providers in an effort to help identify, assess and manage the Company's cybersecurity threats and risks, including for example, professional services firms (such as outside legal counsel) and cybersecurity consultants.

We use third-party service providers to perform a variety of functions throughout our business, including, for example, application providers, hosting companies, contract research organizations, and contract manufacturing organizations. Depending on the nature of the services provided, the sensitivity of the systems and data at issue, and the identity of the provider, our vendor engagement processes may include risk assessments, security evaluations, audit requirements, and imposition of cybersecurity obligations.

We have integrated our assessment and management of material risks from cybersecurity threats into our overall risk management systems and processes. For example, our senior management evaluates material risks from cybersecurity threats against our overall business objectives and reports to the board or the board's audit committee which evaluates our overall enterprise risks.

For a description of the risks from cybersecurity threats that may materially affect the Company and how they may do so, see our risk factors under Part 1. Item 1A. Risk Factors in this Annual Report on Form 10-K, including the risk entitled "If our information systems or data, or those of our collaborators, contractors, consultants or other third parties with whom we work, are or were compromised, we could experience adverse consequences, including but not limited to regulatory investigations or actions; litigation; fines and penalties; significant disruption of our product development programs and our ability to operate our business effectively; reputational harm; and other adverse consequences."

***Governance*** 

Our board of directors addresses our cybersecurity risk management as part of its general oversight function. The board of directors' audit committee is responsible for overseeing our cybersecurity risk management processes, including oversight and mitigation of risks from cybersecurity threats.

Our Vice President of Engineering, Vice President of Product, and General Counsel integrate cybersecurity risk considerations into the Company's overall risk management strategy, communicate key priorities to relevant personnel, help prepare for cybersecurity incidents, approve cybersecurity processes, and review security assessments and other security-related reports.

Our Vice President of Engineering has approximately 15 years of experience in healthcare technology, including prior roles at Flatiron Health and Epic Systems involving systems that process sensitive patient data. He has expertise in designing and operating systems subject to HIPAA and SOC 2 compliance requirements, including security architecture review, access control and authentication design, and participation in SOC 2 and HIPAA audit and incident response processes.

Our Vice President of Product has over 20 years of experience delivering products across the healthcare ecosystem, including digital health products used in clinical trial management and pharmaceutical ordering. He has experience managing products subject to HIPAA and 21 CFR Part 11 regulatory requirements and maintains training related to HIPAA, data privacy, and security practices in regulated healthcare environments.

Our General Counsel oversees the Company's cybersecurity incident response processes and evaluates cybersecurity risks in the context of SEC disclosure obligations. He has prior experience advising public and private companies on regulatory compliance and risk management, including matters involving data privacy and information security.

Our cybersecurity incident response processes are designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including our General Counsel. The General Counsel works with the Company's incident responders in an effort to help mitigate and remediate cybersecurity incidents of

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which he is notified. In addition, our incident response processes include reporting to our disclosure committee and audit committee of the board of directors for certain cybersecurity incidents.

Our audit committee receives periodic reports from management concerning the Company's significant cybersecurity threats and risks and the processes designed to address them. The audit committee also receives various reports, summaries or presentations related to cybersecurity threats, risk and mitigation.

**Item 2. Properties.** 

We have leased office and laboratory space in Boston, Massachusetts pursuant to a lease that expires in September 2026. We also lease office and laboratory space in Rockville, Maryland at 1405 Research Blvd, Suite 125, which serves as our principal executive office. The Rockville research operations were wound down in connection with the 2024 Restructuring, and the space is currently used on a limited basis for administrative purposes. The lease expires in 2027. We believe that our current facilities are adequate to meet our ongoing needs, and that, if we require additional space, we will be able to obtain additional facilities on commercially reasonable terms.

**Item 3. Legal Proceedings.** 

We are not currently a party to any material legal proceedings. From time to time, we may become involved in other litigation or legal proceedings relating to claims arising from the ordinary course of business.

**Item 4. Mine Safety Disclosures.**

Not applicable.

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**PART II**

**Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.** 

**Dividend Policy**

We have never declared or paid cash dividends on our capital stock. We currently intend to retain all available funds and future earnings, if any, to fund the development and expansion of our business, and we do not anticipate paying any cash dividends in the foreseeable future. Any future determination regarding the declaration and payment of dividends, if any, will be at the discretion of our board of directors and will depend on then-existing conditions, including our financial condition, operating results, contractual restrictions, capital requirements, business prospects and other factors our board of directors may deem relevant. Our future ability to pay cash dividends on our capital stock may also be limited by the terms of any future debt or preferred securities or future credit facility.

**Stockholders**

Our common stock is listed on the Nasdaq Capital Market under the symbol "SNSE". As of March 23, 2026, we had 1,340,281 shares of common stock outstanding held by 193 holders of record. The actual number of stockholders is greater than this number of record holders and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees. This number of holders of record also does not include stockholders whose shares may be held in trust by other entities.

**Use of Proceeds from Initial Public Offering of Common Stock**

Not applicable.

**Recent Sales of Unregistered Securities**

On February 17, 2026, we completed the Acquisition pursuant to the Merger Agreement. In connection with the closing of the Acquisition, we issued to the stockholders of Faeth HoldCo an aggregate of 10,497.0980 shares of our Series B Non-Voting Convertible Preferred Stock. Each share of Series B Preferred Stock is convertible into 1,000 shares of our common stock, representing 10,497,098 shares on an as-converted-to-common-stock basis (without giving effect to any beneficial ownership limitations), subject to stockholder approval of the Company Stockholder Matters and certain beneficial ownership limitations established by each holder. The shares of Series B Preferred Stock issued as Acquisition consideration were offered and sold in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated thereunder.

On February 20, 2026, we completed a private placement of 14,440.395 shares of our Series B Preferred Stock at a purchase price of approximately $13,850 per share (or approximately $13.85 per share on an as-converted-to-common-stock basis) for aggregate gross proceeds of approximately $200 million. The investors in the 2026 Private Placement included B Group Capital, Balyasny Asset Management, Columbia Threadneedle Investments, Cormorant Asset Management, Fairmount, Logos Capital, RA Capital Management, Vivo Capital and other institutional investors. The Series B Preferred Stock issued in the 2026 Private Placement was offered and sold in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated thereunder, as a transaction by an issuer not involving a public offering. Each of the investors represented that it was an "accredited investor" as defined in Regulation D and acquired the securities for investment only and not with a view to or for sale in connection with any distribution thereof.

Subject to stockholder approval of the Company Stockholder Matters, each share of Series B Preferred Stock will automatically convert into 1,000 shares of common stock, subject to certain beneficial ownership limitations established by each holder; provided that such beneficial ownership limitations may be waived by each holder of Series B Preferred Stock at any time following the approval by Nasdaq of the Nasdaq Listing Application

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and approval of the Company Stockholder Matters upon notice to the Company. We have agreed to file a registration statement on Form S-3 to register the resale of shares of common stock issuable upon conversion of the Series B Preferred Stock within 75 calendar days following the closing of the 2026 Private Placement.

For additional information regarding the Acquisition and the 2026 Private Placement, see the Current Report on Form 8-K filed with the SEC on February 18, 2026 and Note 15 to the consolidated financial statements included elsewhere in this Annual Report.

**Purchases of Equity Securities by the Issuer and Affiliated Parties**

None.

**Item 6. Reserved.** 

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**Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations.** 

*You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and the related notes and other financial information included elsewhere in this Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. You should review the "Risk Factors" section of this Report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.* 

*In this section, we discuss our financial condition, changes in financial condition and results of our operations for the year ended December 31, 2025, compared to the year ended December 31, 2024. For a discussion and analysis comparing our results for the year ended December 31, 2024, to the year ended December 31, 2023, see our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 28, 2025, under Part II, Item 7 "Management's Discussion and Analysis of Financial Condition and Results of Operations."*

*Unless otherwise indicated, all information in this Annual Report on Form 10-K gives effect to a 1-for-20 reverse stock split of our common stock that became effective on June 16, 2025 (the "Reverse Stock Split"), and all references to historical share and per share amounts give effect to the Reverse Stock Split.*

**Overview** 

We are a clinical-stage biotechnology company focused on improving outcomes for cancer patients through multi-node inhibition of critical oncogenic pathways. On February 17, 2026, we completed the Acquisition of Faeth Therapeutics, a clinical-stage biotechnology company developing multi-node therapies targeting tumor metabolism and signaling, and received $200 million in gross proceeds from the 2026 Private Placement from a broad syndicate of institutional investors. The acquisition brought Faeth's lead asset, PIKTOR, a proprietary investigational all-oral combination of serabelisib and sapanisertib that inhibits multiple nodes of the PI3K/AKT/mTOR pathway, into our pipeline. Because the Acquisition and 2026 Private Placement closed subsequent to the balance sheet date, the consolidated financial statements included in this Report reflect only the pre-acquisition operations of Sensei Biotherapeutics. For additional information regarding the terms of the acquisition and the concurrent financing, see Note 15 to the consolidated financial statements.

Following the acquisition, our lead program is PIKTOR, an oral multi-node inhibitor of the PI3K/AKT/mTOR pathway in development for endometrial and breast cancer. The PI3K/AKT/mTOR pathway is dysregulated in up to 50% of all solid tumors, making it one of the most prevalent therapeutic targets in oncology. Our core thesis is that simultaneously suppressing multiple pathway nodes can produce deeper, more durable tumor suppression than approved therapies that target only a single node. PIKTOR is currently being evaluated in an ongoing Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201), with topline data anticipated by year-end 2026, and we intend to initiate a Phase 1b trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101) by the first half of 2026. We believe the $200 million in financing proceeds, together with our existing cash and cash equivalents, will be sufficient to fund operations through these key clinical milestones.

Prior to the Acquisition, we were primarily focused on the development of solnerstotug (formerly SNS-101), our conditionally active monoclonal antibody targeting the immune checkpoint VISTA. In November 2025, our Board of Directors approved a reduction in force of approximately 65% of our pre-acquisition workforce, referred to herein as the 2025 Restructuring, to preserve capital while we evaluated strategic alternatives, including the Acquisition. We are completing the remaining portions of the solnerstotug Phase 1/2 trial with patients currently on study.

We have incurred significant operating losses since our inception and expect to continue to incur losses for the foreseeable future. Our net loss was $21.1 million and $30.2 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $283.1 million and cash, cash equivalents and marketable securities of $21.2 million, which does not include the $200 million in gross proceeds received in the February 2026 Private Placement. The decrease in our net loss in 2025 was primarily attributable to reduced research and development spending resulting from the wind-down of our legacy programs, together with the 2024 Restructuring and the 2025 Restructuring. We expect our research and development expenses to increase significantly in future periods as we advance the clinical development of PIKTOR and other candidates acquired in the Acquisition. We also expect to incur increased general and administrative expenses related to the integration of

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Faeth's operations and the support of our expanded product pipeline. We have not generated any product revenue and do not expect to do so for the foreseeable future, if ever.

**Components of Our Results of Operations** 

***Operating Expenses*** 

*Research and Development Expense* 

Our research and development expense consists of expenses incurred in connection with the discovery and development of our product candidates. These expenses include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•expenses incurred under agreements with CROs, as well as investigative sites and consultants that conduct our preclinical studies and clinical trials;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the cost of manufacturing our product candidates including the cost of CMOs that manufacture product for use in our preclinical studies and clinical trials and perform analytical testing, scale-up and other services in connection with our development activities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the cost of outsourced professional scientific development services;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•employee-related expenses, including salaries, benefits and stock-based compensation for employees engaged in the research and development function;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•expenses relating to regulatory activities, including filing fees paid to regulatory agencies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•fees for maintaining licenses and other amounts due under our third party licensing agreements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•laboratory materials and supplies used to support our research activities; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•allocated expenses for utilities and other facility-related costs.

We expense all research and development costs in the periods in which they are incurred. Costs for certain research and development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and third-party service providers.

Our direct external research and development expenses consist primarily of third party costs, such as fees paid to CROs, CMOs, research/testing laboratories and outside consultants in connection with our preclinical development, process development, manufacturing and clinical development activities. We do not allocate these costs to specific product candidates because many of them are deployed across several of our development programs and, as such, are not separately classified. We have historically used internal resources primarily to conduct research and manage our preclinical development, process development, manufacturing and clinical development activities. These employees have worked across multiple development programs and, therefore, we have not historically tracked their costs by program and, as such, are not separately classified. Research and 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 of the Acquisition in February 2026, we generally expect that our research and development expenses will increase as we initiate and advance clinical development of PIKTOR and other candidates acquired.

The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the remainder of the development of, or when, if ever, material net cash inflows may commence from any of our product candidates. This uncertainty is due to the numerous risks and uncertainties associated with the duration and cost of clinical trials, which vary significantly over the life of a project as a result of many factors, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the scope, progress, outcome and costs of our preclinical studies, our current product candidates and any other product candidates we may acquire or develop;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•manufacturing of our product candidates or making arrangements with third-party manufacturers for both clinical and commercial supplies of these product candidates;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•successful patient enrollment in, and the initiation, duration and completion of clinical trials;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the cost of gaining regulatory approvals for our product candidates, subject to the successful outcome of ongoing and future clinical trials; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the extent of any required post-marketing approval commitments to applicable regulatory authorities.

Our expenditures are subject to additional uncertainties, including the terms and timing of regulatory approvals. We may never succeed in achieving regulatory approval for any of our product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate, or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development. Product commercialization will take several years and significant additional development costs.

*General and Administrative Expense* 

General and administrative expenses consist principally of salaries and related costs for personnel in executive, administrative, finance and legal functions, including stock-based compensation, travel and recruiting expenses. Other general and administrative expenses include facility related costs, patent filing and prosecution costs and professional fees for legal, auditing and tax services, and insurance costs.

We anticipate that our general and administrative expenses will increase due to costs incurred to integrate Faeth's operations and to support the expanded product pipeline. These anticipated increases include higher personnel-related costs as we integrate the Faeth team and the ongoing requirements of managing an expanded clinical-stage pipeline.

*Long-Lived Asset Impairment*

Our long-lived asset impairments consisted of charges related to the write-down of certain equipment and finance right-of-use assets due to streamlining operations and focusing resources on advancing the clinical development of our former lead product solnerstotug in 2024. There were no long-lived asset impairment charges recorded during the year ended December 31, 2025.

*Other Income (Expense)*

Our other income (expense) consists of accretion on short-term investments, interest expense and gain or loss on fixed asset disposals.

*Income Taxes* 

Since our inception, we have not recorded any income tax benefits for the net losses we have incurred or for the research and development tax credits earned in each year, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credit carryforwards will not be realized.

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***Comparison of Years Ended December 31, 2025 and 2024***

The following sets forth our results of operations for the years ended December 31, 2025 and 2024:

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| | | | |
|:---|:---|:---|:---|
|  | **For the Twelve Months Ended December 31,** | **For the Twelve Months Ended December 31,** |  |
| **(in thousands)** | **2025** | **2024** | **Change** |
| Operating expenses: |  |  |  |
| &nbsp;&nbsp;&nbsp;Research and development | $10960 | $18627 | $(7667) |
| &nbsp;&nbsp;&nbsp;General and administrative | 11328 | 13036 | (1708) |
| &nbsp;&nbsp;&nbsp;Long-lived asset impairment |  | 951 | (951) |
| Total operating expenses | 22288 | 32614 | (10326) |
| Loss from operations | (22288) | (32614) | 10326 |
| Total other income | 1203 | 2457 | (1254) |
| Net loss | $(21085) | $(30157) | $9072 |

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*Research and Development Expenses* 

Research and development expenses were $11.0 million for the year ended December 31, 2025, compared to $18.6 million for the year ended December 31, 2024. The decrease of $7.7 million was primarily attributable to $3.1 million of lower personnel costs, including non-cash stock-based compensation and incentives, $1.4 million of lower facilities and equipment cost, $1.1 million less expense relating to lab supply purchases, $0.9 million of lower expense associated with clinical trials, $0.5 million of lower manufacturing cost, $0.4 million less outside research fees, $0.3 million of lower preclinical research expense and $0.2 million of decreased restructuring costs, partially offset by $0.2 million of higher consulting expense.

*General and Administrative Expenses* 

General and administrative expenses were $11.3 million for the year ended December 31, 2025, compared to $13.0 million for the year ended December 31, 2024. The decrease of $1.7 million was primarily attributable to $3.0 million of lower personnel costs, including recruiting, non-cash stock-based compensation and incentives and $0.1 million of lower board fees, partially offset by $1.0 million for higher restructuring costs, $0.3 million of higher consulting cost and $0.1 million higher cost for external administrative fees.

*Long-Lived Asset Impairment*

Long-lived asset impairment expenses were $1.0 million for the year ended December 31, 2024, related to $0.6 million of financing right-of-use equipment lease impairments and $0.4 million of fixed asset impairments.

*Other Income (Expense)*

Other income was $1.2 million and $2.5 million for the years ended December 31, 2025 and 2024, respectively, primarily attributable to interest and accretion on investments.

**Liquidity and Capital Resources** 

*Sources of Liquidity* 

Since our inception, we have not generated any product revenue and have incurred net losses and negative cash flows from our operations. As of December 31, 2025, we had cash, cash equivalents and marketable securities of $21.2 million. We have financed our operations through sales of our common stock, convertible preferred stock and convertible debt. Through the date of this Report, we have raised an aggregate of $123.4 million of gross proceeds from private placements of our equity and convertible debt securities, net proceeds of $138.5 million from our initial public offering in February 2021 and gross proceeds of $200 million from the 2026 Private Placement completed in February 2026. Our net loss was $21.1 million and $30.2 million for the years ended December 31,

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2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $283.1 million. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures.

***Cash Flows*** 

The following table summarizes our sources and uses of cash for each of the periods below:

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| | | |
|:---|:---|:---|
|  | **For the Twelve Months Ended December 31,** | **For the Twelve Months Ended December 31,** |
| **(in thousands)** | **2025** | **2024** |
| Net cash used in operating activities | $(20453) | $(24670) |
| Net cash provided by investing activities | 19772 | 22440 |
| Net cash used in financing activities | (645) | (787) |
| Net decrease in cash and cash equivalents | $(1326) | $(3017) |

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*Operating Activities* 

During the year ended December 31, 2025, our operating activities used $20.5 million of cash, resulting from our $21.1 million net loss and a $1.6 million decrease related to changes in our operating assets and liabilities partially offset by increases in non-cash charges of $2.2 million, primarily related to $1.5 million of non-cash lease expense, $1.3 million of stock compensation expense and $0.1 million of depreciation partially offset by $0.7 million of accretion on marketable securities. During the year ended December 31, 2024, our operating activities used $24.7 million of cash, resulting from our $30.2 million net loss and a $0.5 million decrease related to changes in our operating assets and liabilities partially offset by increases in non-cash charges of $6.0 million primarily related to $3.1 million of stock compensation expense, $1.6 million of non-cash lease expense, $0.8 million of amortization of financing lease right-of-use assets, $0.6 million for financing right-of-use asset impairments, $0.6 million of depreciation and $0.3 million of loss on fixed asset impairments, partially offset by $1.0 million of accretion on marketable securities.

*Investing Activities* 

During the year ended December 31, 2025, net cash provided by investing activities was $19.8 million, primarily due to $44.7 million in maturities of short-term investments and $0.3 million in proceeds from the sale of property and equipment, partially offset by $25.2 million in purchases of short-term investments. During the year ended December 31, 2024, net cash used in investing activities was $22.4 million primarily due to $67.2 million in maturities of short-term investments partially offset by $44.6 million in purchases of short-term investments and $0.2 million in purchases of property and equipment.

*Financing Activities* 

During the year ended December 31, 2025, net cash used in financing activities was $0.6 million, primarily from $0.8 million of principal payments under our financing leases, partially offset by $0.1 million in proceeds from the sale of financing leased assets. During the year ended December 31, 2024, net cash used in financing activities was $0.8 million, consisting of $0.8 million of principal payments under our financing leases.

***Material Cash Requirements*** 

Our material cash requirements will have an impact on our future liquidity. Our material cash requirements represent material expected or contractually committed future payment obligations.

*Operating Leases*

We have operating lease arrangements for our corporate offices, lab facilities and an executive residence. As part of our adoption of Accounting Standards Codification, or ASC, 842, we recorded operating right-of-use assets

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and operating lease liabilities for these agreements. As of December 31, 2025, we had operating lease payment obligations of $1.5 million, with $1.4 million payable within twelve months. See Note 6 in our annual financial statements included elsewhere in this Report for additional information.

*Finance Leases*

We lease research equipment, furniture and a vehicle under finance leases. As part of our adoption of ASC 842, we recorded financing right-of-use assets and financing lease liabilities for these leases as of January 1, 2022. As of December 31, 2025, we had finance lease payment obligations of $0.1 million, with $0.1 million payable within 12 months. See Note 6 in our annual financial statements included elsewhere in this Report for additional information.

In the biopharmaceutical industry, it can take a significant amount of time and capital resources to successfully complete all stages of research and development and commercialize a product candidate. The ultimate length of time and spend required cannot be accurately estimated as it varies substantially according to the type, complexity, novelty and intended use of a product candidate. Please see the "Funding Requirements" section below for further details.

In addition, our future capital requirements will depend on many factors, including, without limitation, the timing of stockholder approval of the Company Stockholder Matters and the potential cash settlement obligations that may arise if we are unable to timely deliver shares of our common stock upon conversion of the Series B Preferred Stock. In connection with the Acquisition, we issued 24,937.493 shares of Series B Preferred Stock, each share of which is convertible into 1,000 shares of our common stock, subject to certain beneficial ownership limitations and receipt of approval of the Company Stockholder Matters. The shares of Series B Preferred Stock will automatically convert upon the third business day following receipt of approval of the Company Stockholder Matters stockholder approval in accordance with Nasdaq listing rules up to the beneficial ownership limitations set by each holder; provided that such beneficial ownership limitations may be waived by each holder of Series B Preferred Stock at any time following the approval by Nasdaq of the Nasdaq Listing Application and approval of the Company Stockholder Matters.

The Certificate of Designation contains a provision that, at any time following the earlier of (i) approval of the Company Stockholder Matters or (ii) six months after the initial issuance of the Series B Preferred Stock, if we fail to deliver shares of our common stock to a converting holder within the time periods required by the Certificate of Designation, such holder may require us to pay, in lieu of delivering the applicable conversion shares, an amount of cash equal to the fair value of the undelivered shares based on the last reported closing sale price of our common stock on the principal trading market on which our common stock is listed as of the trading day immediately prior to the date on which the applicable notice of conversion was delivered to us. Such payment would be required within two business days of the holder's request.

If we are unable to obtain approval of the Company Stockholder Matters or approval of the Nasdaq Listing Application, or if we are otherwise unable to timely deliver shares of our common stock upon conversion — whether due to an insufficient number of authorized shares, Nasdaq listing requirements, or other factors — we could become obligated to make significant cash settlement payments to holders of Series B Preferred Stock who submit conversion notices after the applicable trigger date. Given the number of shares of Series B Preferred Stock outstanding and the potential magnitude of such cash settlement obligations, which would be determined by reference to the then-current trading price of our common stock, any such payments could require us to use a substantial portion of our available cash resources or to seek additional financing to satisfy these obligations, which could materially limit the amount of cash available to fund our operations and advance our clinical programs.

Additionally, even following stockholder approval of the Company Stockholder Matters, certain holders may be unable to convert their shares of Series B Preferred Stock due to the application of beneficial ownership limitations set by such holder. Shares of Series B Preferred Stock that are not converted in the automatic conversion on account of beneficial ownership limitations will remain outstanding until converted at the option of the applicable holder, and the cash settlement provisions described above would apply to any failure to timely deliver conversion shares in connection with any such optional conversion.

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***Funding Requirements*** 

We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, initiate clinical trials of, and potentially seek marketing approval for, our product candidates. In addition, we expect to continue to incur significant 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:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the initiation, progress, timing, costs and results of current and future preclinical studies and clinical trials for our current and future product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the cost and timing of the manufacture of additional clinical trial material as well as any costs related to the scale-up of manufacturing activities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the costs to seek regulatory approvals for any product candidates that successfully complete clinical trials;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the need to hire additional clinical, quality assurance, quality control and other scientific personnel;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the number and characteristics of product candidates that we develop or may in-license;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the outcome, timing and cost of meeting and maintaining compliance with regulatory requirements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the terms of any collaboration agreements we may choose to enter into, including the achievement of milestones or occurrence of other developments that trigger payments under any license or collaboration agreements we might have at such time;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the cost associated with the expansion of our operational, financial and management systems and increased personnel, including personnel to support our operations as a public company; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products, if approved, on our own.

We expect our existing cash and cash equivalents, together with the proceeds from the 2026 Private Placement, will enable us to fund our operating expenses and capital expenditure requirements through topline data readouts from both our ongoing Phase 2 trial of PIKTOR in advanced endometrial cancer (Study FTH-PIK-201) and our planned Phase 1b trial of PIKTOR in HR+/HER2- advanced breast cancer (Study FTH-PIK-101). We have based this estimate on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the scope, progress, results and costs of product discovery, preclinical studies and clinical trials;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the scope, prioritization and number of our research and development programs;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the costs, timing and outcome of regulatory review of our product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•our ability to establish and maintain collaborations on favorable terms, if at all;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under collaboration agreements, if any;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the extent to which we acquire or in-license other product candidates and technologies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the costs of securing manufacturing arrangements for commercial production; and

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory approvals to market our product candidates.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest may be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely affect your rights as a common stockholder. 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. In addition, debt financing would result in fixed payment obligations.

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our 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.

**Critical Accounting Estimates**

This Management's Discussion and Analysis of Financial Condition and Results of Operations is based on our financial statements, which are prepared in accordance with US GAAP. The preparation of our financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, costs and expenses. We base our estimates and assumptions on historical experience and other factors that we believe to be reasonable under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates.

We define our critical accounting policies as those accounting principles that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. While our significant accounting policies are described in Note 2 to our annual financial statements beginning on page F-1 of this Report, we believe the following are the critical accounting policies used in the preparation of our financial statements that require significant estimates and judgments.

***Accrued Research and Development Expenses*** 

We incur expenses associated with preclinical development and clinical trials. Accounting for preclinical or clinical activities relating to work performed by CROs and other external vendors requires management to exercise significant estimates in regard to the timing and accounting for these expenses. We estimate costs of research and development activities conducted by service providers, which include, the conduct of sponsored research, preclinical studies and contract manufacturing activities. The diverse nature of services being provided under CRO and other arrangements, the different compensation arrangements that exist for each type of service and the lack of timely information related to certain clinical activities complicates the estimation of accruals for services rendered by CROs and other vendors in connection with clinical trials. We record the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced and include these costs in the accrued and other current liabilities or prepaid expenses on the balance sheets and within research and development expense on the consolidated statements of operations. We determine the estimated costs through discussions with the internal personnel and external service providers as to the progress, or stage of completion of the services and the agreed-upon fees to be paid for such services. This process involves a thorough review of open contracts and evaluation by internal personnel to identify services received that have been performed for us and estimating the associated cost incurred for these services for which we have not yet been invoiced or otherwise notified of the actual cost. In estimating the duration of a clinical study, we evaluate the start-up, treatment and

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wrap-up periods, compensation arrangements and services rendered attributable to each clinical trial and fluctuations are regularly tested against payment plans and trial completion assumptions.

Our expenses related to clinical trials are based on estimates of patient enrollment and related expenses at clinical investigator sites as well as estimates for the services received and efforts expended pursuant to contracts with multiple research institutions and CROs that may be used to conduct and manage clinical trials on our behalf. We determine the estimated costs through discussions with internal personnel and external service providers as to the progress, or stage of completion of the services and the agreed-upon fees to be paid for such services. We generally accrue expenses related to clinical trials based on contracted amounts applied to the level of patient enrollment and activity. If timelines or contracts are modified based upon changes in the clinical trial protocol or scope of work to be performed, we modify our estimates of accrued expenses accordingly on a prospective basis.

***Stock-Based Compensation*** 

We measure all stock-based awards granted based on their estimated fair value on the date of the grant and recognize the corresponding compensation expense for those awarded to employees and directors over the requisite service period, which is generally the vesting period of the respective award, and for those awarded to nonemployees over the period during which services are rendered by nonemployees until completed. We have typically issued stock options and warrants with service-based vesting conditions and we record the expense for these awards using the straight-line method.

We estimate the fair value of each stock option grant using the Black-Scholes option-pricing model, which uses as inputs the closing price of our common stock and assumptions we make for the volatility of our common stock, the expected term of our stock options and warrants, the risk-free interest rate for a period that approximates the expected term of our stock options and warrants and our expected dividend yield. The fair value of our stock options and warrants on the date of grant, prior to February 3, 2021, was determined by us with the assistance of a third-party valuation specialist in accordance with the guidance in the American Institute of Certified Public Accountants Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation, as our common stock was not actively traded.

**Recent Accounting Pronouncements** 

See Note 2 in our annual financial statements included elsewhere in this Report for a description of recent accounting pronouncements applicable to our financial statements. Other than as disclosed in our financial statements, we do not expect that any recently issued accounting standards will have a material impact on our financial statements or will otherwise apply to our operations.

**Emerging Growth Company and Smaller Reporting Company Status** 

We qualify as an Emerging Growth Company, or EGC, as defined in the JOBS Act. As an EGC, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies, including reduced disclosure about our executive compensation arrangements, exemption from the requirements to hold non-binding advisory votes on executive compensation and golden parachute payments and exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting.

We may take advantage of these exemptions until the last day of the fiscal year following the fifth anniversary of our initial public offering or such earlier time that we are no longer an emerging growth company. We would cease to be an EGC earlier if we have more than $1.235 billion in annual revenue, we have more than $700.0 million in market value of our stock held by non-affiliates (and we have been a public company for at least 12 months and have filed one annual report on Form 10-K) or we issue more than $1.0 billion of non-convertible debt securities over a three-year period. For so long as we remain an EGC, we are permitted, and intend, to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not EGCs. We may choose to take advantage of some, but not all, of the available exemptions.

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In addition, the JOBS Act provides that an EGC can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an EGC to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected not to "opt out" of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised 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 EGC. Therefore, the reported results of operations contained in our consolidated financial statements may not be directly comparable to those of other public companies.

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 is 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 EGC, 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 on Form 10-K and, similar to EGCs, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

**Item 7A. Quantitative and Qualitative Disclosures About Market Risk.** 

We are a smaller reporting company as defined by Item 10 of Regulation S-K and are not required to provide the information otherwise required under this item.

**Item 8. Financial Statements and Supplementary Data.** 

The financial statements required to be filed pursuant to this Item 8 are appended to this Annual Report on Form 10-K. An index of those financial statements is found in Item 15, Exhibits and Financial Statement Schedules, of this Annual Report on Form 10-K.

**Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.**

None.

**Item 9A. Controls and Procedures.**

*Evaluation of Disclosure Controls and Procedures*

Our management, with the participation of our Principal Executive Officer, or PEO, and Principal Financial Officer, or PFO, evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act as of December 31, 2025. Our disclosure controls and procedures are designed to provide reasonable assurance that information we are required to disclose in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our PEO and PFO, as appropriate to allow timely decisions regarding required disclosures, and is recorded, processed, summarized, and reported within the time periods specified in the SEC's rules and forms. Based on this evaluation, our PEO and PFO have concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2025.

*Management's Report on Internal Control over Financial Reporting and Attestation Report of the Registered Public Accounting Firm*

Our management is responsible for establishing and maintaining an adequate system of internal control over financial reporting, as defined in the Exchange Act Rule 13a-15(f). Management conducted an assessment of our

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internal control over financial reporting based on the framework established in 2013 by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control—Integrated Framework. Based on the assessment, management concluded that, as of December 31, 2025, our internal control over financial reporting was effective.

This Report does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting as required by Section 404(b) of the Sarbanes Oxley Act of 2002. Because we qualify as an emerging growth company under the JOBS Act, management's report was not subject to attestation by our independent registered public accounting firm.

*Changes in Internal Control Over Financial Reporting*

There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2025, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

*Inherent Limitations on Effectiveness of Controls*

Management recognizes that a control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud or error, if any, have been detected. These inherent limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

**Item 9B. Other Information.** 

*Rule 10b5-1 Trading Plans*

During the fiscal quarter ended December 31, 2025, none of our officers or directors, as defined in Rule 16a-1(f), adopted, modified or terminated a "Rule 10b5-1 trading arrangement" or a "non-Rule 10b5-1 trading arrangement," as those terms are defined in Item 408 of Regulation S-K.

*Elimination of Series A Preferred Stock* 

As previously reported, on March 7, 2023, the Special Committee of the Board of Directors of the Company adopted a stockholder rights plan and declared a dividend of one right, or a Right, for each outstanding share of common stock of the Company. Each Right entitled the registered holder thereof under certain circumstances to purchase from the Company one ten-thousandth of a share of Series A Junior Participating Cumulative Preferred Stock. The terms of the Rights were set forth in a Stockholder Rights Agreement, dated as of March 7, 2023, between the Company and American Stock Transfer & Trust Company, LLC, as rights agent, or, as amended, the Rights Agreement.

The Rights expired pursuant to the terms of the Rights Agreement on March 7, 2025. Accordingly, on March 26, 2025, the Company filed with the Secretary of State of the State of Delaware a Certificate of Elimination eliminating from its Amended and Restated Certificate of Incorporation, as amended, the designation of certain shares of its preferred stock as Series A Junior Participating Cumulative Preferred Stock, which had been designated for potential use in connection with the Rights Agreement. As a result, all shares of preferred stock previously

------

designated as Series A Junior Participating Cumulative Preferred Stock were eliminated and returned to the status of authorized but unissued shares of preferred stock, without designation.

The foregoing description of the Certificate of Elimination does not purport to be complete and is subject to and qualified in its entirety by reference to the full text of the Certificate of Elimination, which is included as Exhibit 3.4 hereto, and is incorporated by reference herein.

**Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections**

Not applicable.

------

**PART III** 

We will file a definitive Proxy Statement for our 2026 Annual Meeting of Stockholders, or the 2026 Proxy Statement, with the SEC, pursuant to Regulation 14A, not later than 120 days after the end of our fiscal year. Accordingly, certain information required by Part III has been omitted under General Instruction G(3) to Form 10-K. Only those sections of the 2026 Proxy Statement that specifically address the items set forth herein are incorporated by reference.

**Item 10. Directors, Executive Officers and Corporate Governance.** 

The information required by Item 10 is hereby incorporated by reference to the sections of the 2026 Proxy Statement under the captions "Information Regarding the Board of Directors and Corporate Governance," "Election of Directors," "Executive Officers" and "Section 16(a) Beneficial Ownership Reporting Compliance."

*Code of Business Conduct and Ethics*

We have adopted a Code of Business Conduct and Ethics, or the Code of Conduct, applicable to all of our employees, executive officers and directors. The Code of Conduct is available on our website at www.senseibio.com. The Audit Committee is responsible for overseeing the Code of Conduct and must approve any waivers of the Code of Conduct for executive officers and directors. If we make any substantive amendments to the Code of Conduct or grant any waiver from a provision of the Code of Conduct to any executive officer or director, we will promptly disclose the amendment or waiver on our website.

*Insider Trading Policy*

We have adopted an insider trading policy governing the purchase, sale, and other dispositions of our securities and those of public companies in which we have business dealings by our directors, executive officers, employees and consultants, that we believe is reasonably designed to promote compliance with insider trading laws, rules and regulations, and the exchange listing standards applicable to us. This policy also prohibits directors, officers, and other employees from engaging in short sales, transactions in put or call options, hedging transactions, margin accounts or other inherently speculative transactions with respect to our stock at any time. In addition, it is the Company's intent to comply with applicable laws and regulations relating to insider trading. A copy of our insider trading policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K.

**Item 11. Executive Compensation.** 

The information required by Item 11 is hereby incorporated by reference to the sections of the 2026 Proxy Statement under the captions "Executive Compensation" and "Non-Employee Director Compensation."

**Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.** 

The information required by Item 12 is hereby incorporated by reference to the sections of the 2026 Proxy Statement under the captions "Security Ownership of Certain Beneficial Owners and Management" and "Securities Authorized for Issuance under Equity Compensation Plans."

**Item 13. Certain Relationships and Related Transactions, and Director Independence.** 

The information required by Item 13 is hereby incorporated by reference to the sections of the 2026 Proxy Statement under the captions "Transactions with Related Persons" and "Independence of the Board of Directors."

**Item 14. Principal Accounting Fees and Services.** 

The information required by Item 14 is hereby incorporated by reference to the sections of the 2026 Proxy Statement under the caption "Ratification of Selection of Independent Registered Public Accounting Firm."

------

**PART IV** 

**Item 15. Exhibits, Financial Statement Schedules.**

(1)Exhibits

------

---

| | |
|:---|:---|
| **Exhibit**<br>**Number** | **Description** |
| 2.1‡ | [<u>Agreement and Plan of Merger, dated February 17, 2026, by and among Sensei Biotherapeutics, Inc., Sapphire First Merger Sub, Inc., Sapphire Second Merger Sub, LLC, Faeth Holdings Therapeutics, Inc. and Faeth Therapeutics, LLC (incorporated by reference to Exhibit 2.1 to the Registrant's Current Report on Form 8-K (File No. 001-39980), filed with the SEC on February 18, 2026)</u>](https://www.sec.gov/Archives/edgar/data/1829802/000119312526056135/d112826dex21.htm) |
| 3.1 | [<u>Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Registrant's Current Report on Form 8-K (File No. 001-39980), filed with the SEC on February 11, 2021).</u>](https://www.sec.gov/Archives/edgar/data/1829802/000119312521037280/d95909dex31.htm) |
| 3.2 | [<u>Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the Registrant's Current Report on Form 8-K (File No. 001-39980), filed with the SEC on December 9, 2022).</u>](https://www.sec.gov/Archives/edgar/data/1829802/000119312522301836/d514100dex31.htm) |
| 3.3 | [<u>Certificate of Designations of the Series A Junior Participating Cumulative Preferred Stock of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant's Current Report on Form 8-K (File No. 001-39980), filed with the SEC on March 7, 2023).</u>](https://www.sec.gov/Archives/edgar/data/1829802/000119312523063093/d470819dex31.htm) |
| 3.4 | [<u>Certificate of Elimination of the Series A Junior Participating Cumulative Preferred Stock of the Registrant (incorporated by reference to Exhibit 3.4 to the Registrant's Annual Report on Form 10-K (File No. 001-39980), filed with the SEC on March 28, 2025).</u>](https://www.sec.gov/Archives/edgar/data/1829802/000095017025046338/snse-ex3_4.htm) |
| 3.5 | [<u>Certificate of Designation of Series B Non-Voting Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Registrant</u>](https://www.sec.gov/Archives/edgar/data/1829802/000119312526056135/d112826dex31.htm)'[<u>s Current Report on Form 8-K (File No. 001-39980), filed with the SEC on February 18, 2026)</u>](https://www.sec.gov/Archives/edgar/data/1829802/000119312526056135/d112826dex31.htm) |
| 4.1\* | [<u>Description of Securities</u>](snse-ex4_1.htm). |
| 4.2‡\* | [<u>Warrant to Purchase Stock, dated as of September 7, 2021, by and between Faeth Therapeutics, Inc. and Western Alliance Bank.</u>](snse-ex4_2.htm) |
| 10.1# | [<u>Form of Indemnification Agreement entered into by and between Sensei Biotherapeutics, Inc. and each director and executive officer (incorporated by reference to Exhibit 10.4 to the Registrant's Registration Statement on Form S-1 (File No. 333-252138)).</u>](https://www.sec.gov/Archives/edgar/data/0001829802/000119312521010054/d43789dex104.htm) |
| 10.2 | [<u>Sensei Biotherapeutics, Inc. 2018 Equity Incentive Plan, as amended, and forms of agreements thereunder (incorporated by reference to Exhibit 10.1 to the Registrant's Registration Statement on Form S-1 (File No. 333-252138)).</u>](https://www.sec.gov/Archives/edgar/data/0001829802/000119312521010054/d43789dex101.htm) |
| 10.3 | [<u>Sensei Biotherapeutics, Inc. 2021 Equity Incentive Plan and forms of agreements thereunder (incorporated by reference to Exhibit 10.2 to the Registrant's Registration Statement on Form S-1 (File No. 333-252138)).</u>](https://www.sec.gov/Archives/edgar/data/0001829802/000119312521023615/d43789dex102.htm) |
| 10.4 | [<u>Sensei Biotherapeutics, Inc. 2021 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.10 to the Registrant's Registration Statement on Form S-1 (File No. 333-252138)).</u>](https://www.sec.gov/Archives/edgar/data/0001829802/000119312521023615/d43789dex1010.htm) |
| 10.5 | [<u>Form of Stock Option Grant Notice and Stock Option Agreement for Inducement Grants Outside of the Sensei Biotherapeutics, Inc. 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.4 to the Registrant's Current Report on Form 8-K (File No. 001-39980), filed with the SEC on February 18, 2026)</u>](https://www.sec.gov/Archives/edgar/data/1829802/000119312526056135/d112826dex104.htm). |
| 10.6#\* | [<u>Faeth Therapeutics, Inc. 2019 Stock Incentive Plan and forms of agreements thereunder.</u>](snse-ex10_6.htm) |
| 10.7# | [<u>Non-Employee Director Compensation Policy (incorporated by reference to Exhibit 10.12 to the Registrant's Annual Report on Form 10-K (File No. 001-39980) filed with the SEC on March 15, 2022).</u>](https://www.sec.gov/Archives/edgar/data/1829802/000095017022003646/snse-ex10_12.htm) |
| 10.8 | [<u>Lease Agreement, by and between Sensei Biotherapeutics, Inc. and Are-Maryland No. 8 Corp., dated as of October 22, 2020 (incorporated by reference to Exhibit 10.9 to the Registrant's Registration Statement on Form S-1 (File No. 333-252138)).</u>](https://www.sec.gov/Archives/edgar/data/0001829802/000119312521010054/d43789dex109.htm) |
| 10.9 | [<u>Lease Agreement, by and between Sensei Biotherapeutics, Inc. and RREF II 451D, LLC, dated as of January 13, 2021 (incorporated by reference to Exhibit 10.14 to the Registrant's Annual Report on Form 10-K (File No. 001-39980) filed with the SEC on March 15, 2022).</u>](https://www.sec.gov/Archives/edgar/data/1829802/000095017022003646/snse-ex10_14.htm) |

---

------

---

| | |
|:---|:---|
| 10.10#\* | [<u>Employment Agreement, dated July 31, 2024, by and between the Registrant and Christopher Gerry</u>](snse-ex10_10.htm) |
| 10.11# | [<u>Employment Agreement dated July 12, 2024, by and between the Registrant and Josiah Craver (incorporated by reference to Exhibit 10.1 to the Registrant's Quarterly Report on Form 10-Q (File No. 001-39980) filed with the SEC on November 11, 2024).</u>](https://www.sec.gov/Archives/edgar/data/1829802/000095017024126748/snse-ex10_1.htm) |
| 10.12# | [<u>Employment Letter between the Company and Anand Parikh, effective February 17, 2026 (incorporated by reference to Exhibit 10.3 to the Registrant's Current Report on Form 8-K (File No. 001-39980), filed with the SEC on February 18, 2026)</u>](https://www.sec.gov/Archives/edgar/data/1829802/000119312526056135/d112826dex103.htm) |
| 10.13# | [<u>Form of Consulting Agreement, dated November 14, 2025, entered into with John Celebi, Edward van der Horst and Stephanie Krebs. (incorporated by reference to Exhibit 10.1 to the Registrant's Quarterly Report on Form 10-Q (File No. 001-39980) filed with the SEC on November 14, 2025).</u>](https://www.sec.gov/Archives/edgar/data/1829802/000119312525281590/snse-ex10_1.htm) |
| 10.14\* | [<u>Amended Retention Agreement, dated as of February 17, 2025, entered into with Christopher Gerry.</u>](snse-ex10_14.htm) |
| 10.15\* | [<u>Amended Retention Agreement, dated as of February 17, 2025, entered into with Josiah Craver.</u>](snse-ex10_15.htm) |
| 10.16 | [<u>Open Market Sales Agreement</u><sup>SM</sup><u>, dated March 15, 2022, by and between the Registrant and Jefferies LLC (incorporated by reference to Exhibit 1.2 to the Registrant's Registration Statement on Form S-3 (File No. 333-263567), filed with the SEC on March 15, 2022).</u>](https://www.sec.gov/Archives/edgar/data/1829802/000119312522076072/d296045dex12.htm) |
| 10.17‡ | [<u>Form of Securities Purchase Agreement, dated as of February 17, 2026, by and among Sensei Biotherapeutics, Inc. and each investor listed on Exhibit A thereto (incorporated by reference to Exhibit 10.1 to the Registrant's Current Report on Form 8-K (File No. 001-39980), filed with the SEC on February 18, 2026)</u>](https://www.sec.gov/Archives/edgar/data/1829802/000119312526056135/d112826dex101.htm) |
| 10.18 | [<u>Form of Registration Rights Agreement, by and among Sensei Biotherapeutics, Inc. and certain investors signatory thereto (incorporated by reference to Exhibit 10.2 to the Registrant's Current Report on Form 8-K (File No. 001-39980), filed with the SEC on February 18, 2026)</u>](https://www.sec.gov/Archives/edgar/data/1829802/000119312526056135/d112826dex102.htm) |
| 10.19†\* | [<u>Exclusive License Agreement, dated as of August 10, 2007, between Faeth Therapeutics, Inc. (as successor in interest to Calithera Biosciences, Inc., Millennium Pharmaceuticals, Inc. and Intellikine, Inc.) and The Regents of the University of California and acting through its Office of Technology Management, University of California San Francisco, as amended by Amendment No. 1 dated as of March 13, 2009, Amendment No. 2 dated as of July 8, 2009, Amendment No. 3 dated as of November 30, 2010, Amendment No. 4 dated September 8, 2014, Amendment No. 5 dated August 4, 2021, and Amendment No. 6 dated as of February 1, 2022.</u>](snse-ex10_19.htm) |
| 10.20†\* | [<u>License Agreement, dated as of March 18, 2019, between Faeth Therapeutics, Inc. (as successor in interest to Petra Pharma Corporation and Ravenna Pharmaceuticals, Inc.) and Takeda Pharmaceutical Company Limited.</u>](snse-ex10_20.htm) |
| 10.21†\* | [<u>Amended and Restated TAK-228 Asset Purchase Agreement, dated as of May 15, 2023, between Faeth Therapeutics, Inc. (as successor in interest to Calithera Biosciences, Inc.) and Millennium Pharmaceuticals, Inc.</u>](snse-ex10_21.htm) |
| 10.22†\* | [<u>Letter Agreement, dated as of May 15, 2023, between Millennium Pharmaceuticals, Inc. and Faeth Therapeutics, Inc.</u>](snse-ex10_22.htm) |
| 10.23†\* | [<u>Letter Agreement dated as of January 29, 2026, between Millennium Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited and Faeth Therapeutics, Inc.</u>](snse-ex10_23.htm) |
| 10.24\* | [<u>Retention Agreement, dated as of December 22, 2025, entered into with Christopher Gerry.</u>](snse-ex10_24.htm) |
| 10.25\* | [<u>Retention Agreement, dated as of December 22, 2025, entered into with Josiah Craver.</u>](snse-ex10_25.htm) |
| 19.1 | [<u>Insider Trading Policy(incorporated by reference to Exhibit 19.1 to the Registrant's Annual Report on Form 10-K (File No. 001-39980), filed with the SEC on March 28, 2025).</u>](https://www.sec.gov/Archives/edgar/data/1829802/000095017025046338/snse-ex19_1.htm) |
| 21.1\* | [<u>Subsidiaries of the Registrant.</u>](snse-ex21_1.htm) |
| 23.1\* | [<u>Consent of Deloitte & Touche LLP, independent registered public accounting firm.</u>](snse-ex23_1.htm) |
| 24.1\* | Power of Attorney (included on signature page). |
| 31.1\* | [<u>Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.</u>](snse-ex31_1.htm) |
| 31.2\* | [<u>Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.</u>](snse-ex31_2.htm) |
| 32.1\*\* | [<u>Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.</u>](snse-ex32_1.htm) |

---

------

---

| | |
|:---|:---|
| 97.1 | [<u>Incentive Compensation Recoupment Policy, adopted on October 2, 2023 (incorporated by reference to Exhibit 97 to the Registrant's Annual Report on Form 10-K (File No. 001-39980) filed with the SEC on February 29, 2024).</u>](https://www.sec.gov/Archives/edgar/data/1829802/000095017024023148/snse-ex97.htm) |
| 101.INS | Inline XBRL Instance Document.  |
| 101.SCH | Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

---

------

\* Filed herewith.

\*\* This certification is being furnished solely to accompany this Report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

# Indicates management contract or compensatory plan.

† Pursuant to Item 601(b)(10) of Regulation S-K, portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the omitted information is (i) not material and (ii) the type of information that the registrant customarily and actually treats as private or confidential.

‡ Certain schedules, annexes and attachments have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant agrees to provide, on a supplemental basis, a copy of any omitted schedules, annexes and attachments to the SEC or its staff upon request.

**Item 16. Form 10-K Summary.**

None.

------

**SIGNATURES**

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized**.**

---

| | | | |
|:---|:---|:---|:---|
|  |  | Sensei Biotherapeutics, Inc. | Sensei Biotherapeutics, Inc. |
| Date: | March 30, 2026 | By: | /s/ Christopher W. Gerry |
|  |  |  | **Christopher W. Gerry** |
|  |  |  | **President and General Counsel** |

---

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Christopher W. Gerry and Josiah Craver, jointly and severally, as his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign this Annual Report on Form 10-K of Sensei Biotherapeutics, Inc., and any or all amendments thereto, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents full power and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises hereby ratifying and confirming all that said attorneys-in-fact and agents, or his, her or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons on behalf of the Registrant in the capacities and on the dates indicated.

---

| | | |
|:---|:---|:---|
| **Name** | **Title** | **Date** |
| /s/ Christopher W. Gerry | President and General Counsel (*Principal Executive Officer*) | March 30, 2026 |
| **Christopher W. Gerry** |  |  |
| /s/ Josiah Craver | Senior Vice President of Finance (*Principal Financial and Accounting Officer)* | March 30, 2026 |
| **Josiah Craver** |  |  |
| /s/ Bob Holmen | Director | March 30, 2026 |
| **Bob Holmen** |  |  |
| /s/ Thomas Ricks | Director | March 30, 2026 |
| **Thomas Ricks** |  |  |
| /s/ Kristian Humer | Director | March 30, 2026 |
| **Kristian Humer** |  |  |
| /s/ Phillip Donenberg | Director | March 30, 2026 |
| **Phillip Donenberg** |  |  |
| /s/ Anand Parikh | Director | March 30, 2026 |
| **Anand Parikh** |  |  |

---

------

**SENSEI BIOTHERAPEUTICS, INC.** 

**INDEX TO CONSOLIDATED FINANCIAL STATEMENTS** 

---

| | |
|:---|:---|
|  | &nbsp;&nbsp;&nbsp;**Page** |
| &nbsp;&nbsp;&nbsp;[<u>Report of Independent Registered Public Accounting Firm</u>](#report_independent_registered_public_acc)(PCAOB ID No. 34) | &nbsp;&nbsp;F-2 |
| &nbsp;&nbsp;&nbsp;&nbsp;[<u>Consolidated Balance Sheets as of December 31, 2025 and 2024</u>](#consolidated_balance_sheets) | &nbsp;&nbsp;F-3 |
| &nbsp;&nbsp;&nbsp;&nbsp;[<u>Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2025 and 2024</u>](#consolidated_statements_operations) | &nbsp;&nbsp;F-4 |
| &nbsp;&nbsp;&nbsp;&nbsp;[<u>Consolidated Statements of Common Stock and Stockholders' Equity for the Years Ended December 31,</u>](#consolidated_statements_convertible_pref)[<u>2025 and 2024</u>](#consolidated_balance_sheets) | &nbsp;&nbsp;F-5 |
| &nbsp;&nbsp;&nbsp;&nbsp;[<u>Consolidated Statements of Cash Flows for the Years Ended December 31,</u>](#consolidated_statements_cash_flows)[<u>2025 and 2024</u>](#consolidated_balance_sheets) | &nbsp;&nbsp;F-6 |
| &nbsp;&nbsp;&nbsp;&nbsp;[<u>Notes to Consolidated Financial Statements</u>](#notes_to_consolidated_financial_statemen) | &nbsp;&nbsp;F-7 |

---

------

**REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM**

To the stockholders and the Board of Directors of Sensei Biotherapeutics, Inc.

**Opinion on the Financial Statements** 

We have audited the accompanying consolidated balance sheets of Sensei Biotherapeutics, Inc. and subsidiaries (the "Company") as of December 31, 2025 and 2024, the related consolidated statements of operations and comprehensive loss, common stock and stockholders' equity, and cash flows, for each of the two years in the period ended December 31, 2025, and the related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.

**Going Concern**

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company may be required to make significant cash payments to holders of Series B Non-Voting Convertible Preferred Stock that could substantially reduce the Company's available cash resources which raises substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

**Basis for Opinion** 

These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ Deloitte & Touche LLP

Baltimore, Maryland

March 30, 2026

We have served as the Company's auditor since 2016.

------

**SENSEI BIOTHERAPEUTICS, INC.** 

**CONSOLIDATED BALANCE SHEETS** 

**(In thousands, except share and per share data)** 

---

| | | |
|:---|:---|:---|
|  | **December 31,<br>2025** | **December 31,<br>2024** |
| **Assets** |  |  |
| Current assets: |  |  |
| &nbsp;&nbsp;&nbsp;Cash and cash equivalents | $8668 | $9994 |
| &nbsp;&nbsp;&nbsp;Marketable securities | 12516 | 31341 |
| &nbsp;&nbsp;&nbsp;Prepaid expenses | 231 | 474 |
| &nbsp;&nbsp;&nbsp;Other current assets | 92 | 120 |
| Total current assets | 21507 | 41929 |
| Right-of-use assets - operating leases, net | 1294 | 2804 |
| Right-of-use assets - financing leases, net | 1 | 163 |
| Property and equipment, net | 82 | 417 |
| Other non-current assets | 18 | 48 |
| Total assets | $22902 | $45361 |
| **Liabilities and stockholders' equity** |  |  |
| Current liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;Accounts payable and accrued liabilities | $1481 | $1248 |
| &nbsp;&nbsp;&nbsp;Compensation and employee benefits liabilities | 1320 | 1882 |
| &nbsp;&nbsp;&nbsp;Operating lease liabilities, current | 1370 | 1586 |
| &nbsp;&nbsp;&nbsp;Financing lease liabilities, current | 80 | 732 |
| Total current liabilities | 4251 | 5448 |
| Operating lease liabilities, non-current | 59 | 1429 |
| Financing lease liabilities, non-current |  | 98 |
| Total liabilities | $4310 | $6975 |
| Commitments and contingencies (Note 6) |  |  |
| Stockholders' equity: |  |  |
| Preferred stock, $0.0001 par value and 10,000,000 shares authorized as of December 31, 2025 and December 31, 2024; zero shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively |  |  |
| Common stock, $0.0001 par value and 12,500,000 shares authorized as of December 31, 2025 and December 31, 2024; 1,261,685 and 1,258,940 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively |  |  |
| Additional paid-in capital | 301728 | 300451 |
| Accumulated deficit | (283137) | (262052) |
| Accumulated other comprehensive loss | 1 | (13) |
| Total stockholders' equity | 18592 | 38386 |
| Total liabilities and stockholders' equity | $22902 | $45361 |

---

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

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**SENSEI BIOTHERAPEUTICS, INC.** 

**CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS** 

**(In thousands, except share and per share data)** 

---

| | | |
|:---|:---|:---|
|  | **For the Year<br>Ended December 31,** | **For the Year<br>Ended December 31,** |
|  | **2025** | **2024** |
| Operating expenses: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Research and development | $10960 | $18627 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;General and administrative | 11328 | 13036 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Long-lived asset impairment |  | 951 |
| Total operating expenses | 22288 | 32614 |
| Loss from operations | (22288) | (32614) |
| Other income (expense): |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Interest income | 1239 | 2550 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Interest expense | (32) | (90) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Other expense, net | (4) | (3) |
| Net loss | (21085) | (30157) |
| Net loss per common share, basic and diluted | $(16.72) | $(24.01) |
| Weighted-average number of shares used in computing net loss per common share, basic and diluted | 1260772 | 1255776 |
| Comprehensive loss: |  |  |
| Net loss | $(21085) | $(30157) |
| Other comprehensive items: |  |  |
| Unrealized gain on marketable securities | 14 | 196 |
| &nbsp;&nbsp;&nbsp;Total other comprehensive income | 14 | 196 |
| Total comprehensive loss | $(21071) | $(29961) |

---

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

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**SENSEI BIOTHERAPEUTICS, INC.** 

**CONSOLIDATED STATEMENTS OF COMMON STOCK AND STOCKHOLDERS' EQUITY** 

**(In thousands, except share data)** 

---

| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
|  | **Common Stock** | **Common Stock** | **Additional Paid-In** | **Accumulated** | **Accumulated Other** | **Total Stockholders'** |
|  | **Shares** | **Amount** | **Capital** | **Deficit** | **Comprehensive Loss** | **Equity** |
| **Balance at December 31, 2023** | 1251432 | $— | $296999 | $(231895) | $(209) | $64895 |
| &nbsp;&nbsp;&nbsp;&nbsp;Stock-based compensation expense |  |  | 3135 |  |  | 3135 |
| &nbsp;&nbsp;&nbsp;&nbsp;Issuance of equity in exchange for compensation |  |  | 293 |  |  | 293 |
| &nbsp;&nbsp;&nbsp;&nbsp;Surrender of shares for tax withholding | (616) |  | (10) |  |  | (10) |
| &nbsp;&nbsp;&nbsp;&nbsp;Vesting of restricted stock shares | 4498 |  |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Employee stock purchase plan expense | 3626 |  | 34 |  |  | 34 |
| &nbsp;&nbsp;&nbsp;&nbsp;Unrealized gain on marketable securities |  |  |  |  | 196 | 196 |
| &nbsp;&nbsp;&nbsp;&nbsp;Net loss |  |  |  | (30157) |  | (30157) |
| **Balance at December 31, 2024** | 1258940 | $— | $300451 | $(262052) | $(13) | $38386 |
| &nbsp;&nbsp;&nbsp;&nbsp;Stock-based compensation expense |  |  | 1274 |  |  | 1274 |
| &nbsp;&nbsp;&nbsp;&nbsp;Surrender of shares for tax withholding | (390) |  | (3) |  |  | (3) |
| &nbsp;&nbsp;&nbsp;&nbsp;Vesting of restricted stock shares | 1768 |  |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Employee stock purchase plan expense | 1004 |  | 5 |  |  | 5 |
| &nbsp;&nbsp;&nbsp;&nbsp;Cash-in-lieu of fractional shares for reverse stock split | (32) |  | (1) |  |  | (1) |
| &nbsp;&nbsp;&nbsp;&nbsp;Exercise of stock options into common stock | 395 |  | 2 |  |  | 2 |
| &nbsp;&nbsp;&nbsp;&nbsp;Unrealized gain on marketable securities |  |  |  |  | 14 | 14 |
| &nbsp;&nbsp;&nbsp;&nbsp;Net loss |  |  |  | (21085) |  | (21085) |
| **Balance at December 31, 2025** | 1261685 | - | 301728 | (283137) | 1 | 18592 |

---

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

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**SENSEI BIOTHERAPEUTICS, INC.** 

**CONSOLIDATED STATEMENTS OF CASH FLOWS** 

**(In thousands)** 

---

| | | |
|:---|:---|:---|
|  | **For the Year Ended December 31,** | **For the Year Ended December 31,** |
|  | **2025** | **2024** |
| **Operating activities** |  |  |
| Net loss | $(21085) | $(30157) |
| Adjustments to reconcile net loss to net cash used in operating activities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Stock-based compensation expense | 1274 | 3135 |
| &nbsp;&nbsp;&nbsp;&nbsp;Depreciation and amortization | 122 | 551 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accretion on marketable securities | (699) | (986) |
| &nbsp;&nbsp;&nbsp;&nbsp;Impairment of financing right-of-use asset assets |  | 609 |
| &nbsp;&nbsp;&nbsp;&nbsp;Impairment of equipment |  | 342 |
| &nbsp;&nbsp;&nbsp;&nbsp;Non-cash lease expense | 1510 | 1554 |
| &nbsp;&nbsp;&nbsp;&nbsp;Amortization of financing lease right-of-use assets | 17 | 771 |
| &nbsp;&nbsp;&nbsp;&nbsp;Changes in operating assets and liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Prepaid expenses | 243 | 694 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Other assets | 80 | 244 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accounts payable and accrued liabilities | 233 | (445) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Compensation and employee benefits | (562) | 666 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Operating lease liabilities | (1586) | (1581) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Other liabilities |  | (67) |
| Net cash used in operating activities | (20453) | (24670) |
| **Investing activities** |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Purchases of property and equipment | (16) | (146) |
| &nbsp;&nbsp;&nbsp;&nbsp;Purchases of short-term investments | (25155) | (44595) |
| &nbsp;&nbsp;&nbsp;&nbsp;Maturities of short-term investments | 44693 | 67181 |
| &nbsp;&nbsp;&nbsp;&nbsp;Proceeds from sale of property and equipment | 250 |  |
| Net cash provided by investing activities | 19772 | 22440 |
| **Financing activities** |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Principal payments for financing leases | (790) | (811) |
| &nbsp;&nbsp;&nbsp;&nbsp;Proceeds from the sale of financing lease assets | 142 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Payment of employee restricted stock tax withholdings | (3) | (10) |
| &nbsp;&nbsp;&nbsp;&nbsp;Employee stock purchase plan proceeds | 5 | 34 |
| &nbsp;&nbsp;&nbsp;&nbsp;Cash in lieu of fractional shares for reverse stock split | (1) |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Exercise of options into common stock | 2 |  |
| Net cash used in financing activities | (645) | (787) |
| Net decrease in cash and cash equivalents | (1326) | (3017) |
| Cash and cash equivalents at beginning of period | 9994 | 13011 |
| Cash and cash equivalents at end of period | $8668 | $9994 |
| **Supplemental disclosure of noncash financing information:** |  |  |
| Issuance of equity in exchange for compensation included in compensation and employee benefits | $— | $293 |
| Initial measurement of operating lease right-of-use assets | $— | $28 |
| Initial measurement of operating lease liabilities | $— | $28 |
| Initial measurement of finance lease right-of-use assets | $— | $1 |

---

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

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**SENSEI BIOTHERAPEUTICS, INC.** 

**NOTES TO consolidated FINANCIAL STATEMENTS** 

**1. ORGANIZATION AND OPERATIONS** 

***Business*** 

Sensei Biotherapeutics, Inc. (the "Company" or "Sensei"), a clinical-stage biotechnology company, was incorporated in 1999 as a Maryland corporation until being incorporated in Delaware on December 1, 2017. The Company is focused on the discovery and development of next-generation therapeutics for cancer patients.

***Liquidity and capital resources***

Since its inception, the Company has devoted substantially all of its resources to advancing development of its portfolio of programs, establishing and protecting its intellectual property, conducting research and development activities, organizing and staffing the Company, business planning, raising capital and providing general and administrative support for these operations. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry including, but not limited to, technical risks associated with the successful research, development and manufacturing of product candidates, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Current and future programs will require significant research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure. Even if the Company's drug development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.

Since its inception, the Company has incurred substantial losses and had a net loss of $21.1 million for the year ended December 31, 2025. As of December 31, 2025, the Company had an accumulated deficit of $283.1 million. The Company expects to generate operating losses and negative operating cash flows for the foreseeable future.

The Company will need additional financing to support its continuing operations and pursue its current strategy. Until such time as the Company can generate significant revenue from product sales, if ever, it expects to finance its operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. The Company may be unable to raise additional funds or enter into such other agreements when needed on favorable terms or at all. The inability to raise capital as and when needed would have a negative impact on the Company's financial condition and its ability to pursue its business strategy. The Company will need to generate significant revenue to achieve profitability, and it may never do so.

As of December 31, 2025, the Company had $21.1 million of cash, cash equivalents and marketable securities. In February 2026, the company completed a private placement financing through the sale of Series B Non-Voting Convertible Preferred Stock, resulting in gross proceeds of $200 million.

The Series B Preferred Stock is subject to automatic conversion into Common Stock upon the third business day following the Company's receipt of stockholder approval in accordance with Nasdaq listing rules. The Certificate of Designation of Preferences, Rights and Limitations of the Series B Non-Voting Convertible Preferred Stock (the "Certificate of Designation") provides that, at any time following the earlier of (i) stockholder approval or (ii) six months after the initial issuance of the Series B Preferred Stock, if the Company fails to timely deliver shares of Common Stock to a converting holder in accordance with the terms of the Certificate of Designation, such holder may require the Company to pay cash in an amount equal to the fair value of the undelivered shares.

The Company's ability to satisfy these potential cash settlement obligations is not entirely within its control, as it is contingent on, among other things, the Company's ability to obtain stockholder approval and to deliver shares of Common Stock upon conversion within the timeframes required by the Certificate of Designation. If the Company is unable to obtain stockholder approval in a timely manner, or is otherwise unable to timely deliver shares of Common Stock upon conversion, holders who submit conversion notices after the applicable trigger date could require the Company to make significant cash payments that could substantially reduce the Company's available cash resources.

After evaluating the conditions described above in the aggregate, the Company has concluded that there is substantial doubt about its ability to continue as a going concern. The accompanying consolidated financial statements have been prepared on the basis that the Company will continue to operate as a going concern, which contemplates it will be able to realize assets and settle liabilities and commitments in the normal course of business for the foreseeable future. Accordingly, the accompanying consolidated financial statements do not include any adjustments that may result from the outcome of these uncertainties.

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***Reverse stock split***

On June 16, 2025, at 5:00 p.m. Eastern Time, the Company effected a 1-for-20 reverse stock split of the Company's issued and outstanding shares of common stock and a corresponding reduction in the total number of authorized shares of its common stock from 250,000,000 shares to 12,500,000 shares, as authorized at the Company's 2025 annual meeting of stockholders held on May 21, 2025 and approved by the Company's board of directors on June 3, 2025. As a result of the Reverse Stock Split, every 20 shares of issued and outstanding common stock were automatically combined into one issued and outstanding share of common stock, without any change in the par value of $0.0001 per share. No fractional shares were issued as a result of the Reverse Stock Split. Stockholders entitled to a fractional share received a cash payment based on the average closing sales price of the Company's common stock on The Nasdaq Stock Market for the five trading days immediately preceding the filing date of the Certificate of Amendment. All historical share and per share amounts reflected throughout the financial statements have been adjusted to reflect the Reverse Stock Split. Proportionate adjustments were made to the per share exercise price and the number of shares of common stock that may be purchased upon exercise of outstanding stock options and warrants, the number of shares of common stock reserved for future issuance under the 2021 Equity Incentive Plan (the "2021 Plan") and the 2021 Employee Stock Purchase Plan (the "2021 ESPP").

**2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES** 

***Basis of Presentation and Principles of Consolidation*** 

The Company has prepared the accompanying consolidated financial statements in conformity with generally accepted accounting principles in the United States ("US GAAP"). The consolidated financial statements include those accounts of the Company and its subsidiaries after elimination of all intercompany accounts and transactions.

***Use of Estimates*** 

The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of expenses during the reporting periods presented. Estimates are used for, but are not limited to, stock-based compensation, accrued research and development expenses, depreciation of equipment, fair value of financial instruments, the Company's ability to continue as a going concern and contingencies. Actual results may differ from those estimates.

***Cash and Cash Equivalents*** 

Cash equivalents are highly liquid investments with an original maturity of 90 days or less at the date of purchase and consist of time deposits and investments in money market funds with commercial banks and financial institutions. As of December 31, 2025, cash and cash equivalents included cash on deposit at commercial banks, and a money market fund that invests in U.S. Government securities.

***Marketable Securities***

Investments consist of marketable securities with original maturities greater than 90 days at the date of purchase. The Company has classified its investments with maturities beyond one year as short-term, based on their highly liquid nature and because such marketable securities represent the investment of cash that is available for current operations. The Company considers its investment portfolio of marketable securities to be available-for-sale. Accordingly, these investments are recorded at fair value (Level 2). Unrealized gains and losses are reported as the accumulated other comprehensive items in stockholders' equity. Amortization and accretion of premiums and discounts are recorded in other income (expense). Realized gains or losses on debt securities are included in interest income or interest expense, respectively. If any adjustment to fair value reflects a decline in value of the investment, the Company considers all available evidence to evaluate the extent to which the decline is other than temporary and, if so, marks the investment to market on the Company's statement of operations and comprehensive loss.

Balance Sheet Risk

The Company maintains each of its cash, cash equivalents and available-for-sale securities balances with high-quality and accredited financial institutions and accordingly, such funds are not exposed to significant credit risk. Periodically the Company maintains deposits in accredited financial intuitions in excess of the federally insured limits. The Company does not believe that it is subject to the unusual credit risk beyond the normal credit risk associated with the commercial banking relationships.

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***Leases*** 

At lease inception, the Company determines if an arrangement is or contains a lease, and if so, assesses the lease for classification as either an operating or finance lease. A lease is classified as a finance lease if any one of the following criteria are met: (i) the lease transfers ownership of the asset by the end of the lease term, (ii) the lease contains an option to purchase the asset that is reasonably certain to be exercised, (iii) the lease term is for a major part of the remaining useful life of the asset, (iv) the present value of the lease payments equals or exceeds substantially all of the fair value of the asset, or (v) the leased asset is of such a specialized nature that it is expected to have no alternative use to the lessor at the end of the lease. A lease is classified as an operating lease if it does not meet any of these criteria.

Leases with a term greater than one year are recognized on the balance sheet as right-of-use ("ROU") assets and current and non-current lease liabilities, as applicable. Leases with a term of one year or less are expensed as rent in the period incurred. The Company elected not to separate lease and non-lease components for all underlying assets. As most of the Company's leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The incremental borrowing rate is determined by using the rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment. Lease terms include options to extend or terminate the lease when it is reasonably certain that the Company will exercise the options. For leases that existed prior to the adoption of Accounting Standards Update No. 2016-02, Leases (Topic 842) ("ASC 842"), the Company used the remaining lease term to determine the appropriate incremental borrowing rate.

***Property and Equipment*** 

Property and equipment are recorded at cost and depreciated or amortized over the estimated useful lives of the assets. Repairs or maintenance costs are expensed as incurred. Depreciation is computed using the straight-line method over the following estimated useful lives:

Office equipment and furniture 3—7 years <br> Research equipment 1—7 years

Leasehold improvements are depreciated over the shorter of their useful life or the life of the lease.

***Fair Value of Financial Instruments*** 

US GAAP requires disclosure of fair value information about financial instruments, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. The framework provides a fair value hierarchy that prioritizes the inputs for the valuation techniques. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements) and minimizes the use of unobservable inputs. The most observable inputs are used, when available. The three levels of the fair value hierarchy are described as follows:

***Level 1***—Inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities in active markets that the Company has the ability to access.

***Level 2***—Inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; inputs other than quoted prices that are observable for the asset or liability; and inputs that are derived from, or corroborated by, observable market data by correlation or other means.

***Level 3***—Inputs to the valuation methodology are unobservable and significant to the fair value measurement.

***Impairment of Long-Lived Assets***

Long-lived assets, such as property and equipment and right of use assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted cash flows expected to be generated by the asset. Impairment losses are then measured by comparing the fair value of assets to their carrying amounts. The Company recorded impairments of $1.0 million for the year ended December 31, 2024, consisting of $0.4 million related to property and equipment and $0.6 million related to right-of-use assets. There were no impairments recorded for the year ended December 31, 2025.

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***Research and Development Costs*** 

Research and development costs are expensed in the period incurred. Research and development costs include payroll and personnel expense; consulting costs; external contract research and development costs; raw materials and allocated overhead such as depreciation and amortization, rent and utilities. Advance payments for goods and services to be used in future research and development activities are recorded as prepaid expenses and are expensed over the service period as the services are provided or when the goods are consumed.

Clinical trial costs are a component of research and development expenses. The Company estimates expenses incurred for clinical trials that are in process based on services performed under contractual agreements with clinical research organizations and actual clinical investigators. Included in the estimates are (1) the fee per patient enrolled as specified in the clinical trial contract with each institution participating in the clinical trial and (2) progressive data on patient enrollments obtained from participating clinical trial sites and the actual services performed. Changes in clinical trial assumptions, such as the length of time estimated to enroll all patients, rate of screening failures, patient drop-out rates, number and nature of adverse event reports, and the total number of patients enrolled can impact the average and expected cost per patient and the overall cost of the clinical trial. The Company monitors the progress of the trials and their related activities and adjusts, when appropriate, the accruals accordingly. Adjustments to accruals are charged to expense in the period in which the facts that give rise to the adjustment become known. In the event of early termination of a clinical trial or site, the Company would accrue an amount based on estimates of the remaining noncancellable obligations associated with winding down the clinical trial or cancelation of a participating site.

***Stock-Based Compensation*** 

The Company accounts for all stock-based compensation, including stock options, restricted stock units and warrants, at fair value and recognizes stock-based compensation expense for those equity awards, net of actual forfeitures, over the requisite service period, which is generally the vesting period of the respective award. Stock-based compensation is classified in the accompanying consolidated statements of operations and comprehensive loss based on the function to which the related services are provided.

The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The assumptions used in calculating the fair value of stock-based payment awards represent management's best estimates. The Company lacks sufficient company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies in addition to its own historical volatility and will continue to do so until it has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company's stock options has been determined utilizing the "simplified" method for awards that qualify as "plain-vanilla" options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. The fair value of restricted stock units are equal to the closing sale price of the Company's common stock on the date of grant.

***Income Taxes*** 

Income taxes are accounted for using the asset and liability method of accounting for taxes. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases, including operating loss carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

A valuation allowance is established when necessary to reduce net deferred tax assets to the amount expected to be realized through future operations. Income tax expense consists of taxes payable for the current period and the net change during the period in deferred tax assets and liabilities.

The Company evaluates its uncertain tax positions based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized. Potential interest and penalties associated with any uncertain tax positions are recorded as a component of income tax expense. Management has evaluated the Company's tax position and concluded that the Company has taken no uncertain tax positions that would require adjustment or disclosure in the consolidated financial statements.

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***Net Loss Per Share*** 

The Company follows the two-class method when computing net loss per share as the Company has issued shares that meet the definition of participating securities. The two-class method determines net loss per share for each class of common and participating securities according to dividends declared or accumulated, and participation rights in undistributed earnings. The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed.

Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period. Diluted net loss attributable to common stockholders is computed by adjusting net loss attributable to common stockholders to reallocate undistributed earnings based on the potential impact of dilutive securities. Diluted loss per share attributable to common stockholders is computed by dividing the diluted net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period, including potential dilutive common stock. For purpose of this calculation, outstanding stock options, stock warrants and convertible preferred stock are considered potential dilutive common stock and are excluded from the computation of net loss per share as their effect is anti-dilutive.

The Company's convertible preferred stock contractually entitles the holders of such shares to participate in dividends but does not contractually require the holders of such shares to participate in losses of the Company. Accordingly, in periods in which the Company reports a net loss, such losses are not allocated to such participating securities. In periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders, since dilutive shares of common stock are not assumed to be outstanding if their effect is anti-dilutive. The Company reported a net loss attributable to common stockholders for the years ended December 31, 2025 and 2024.

***Segments*** 

The Company manages its operations as a single segment, dedicated to improving outcomes for cancer patients by developing novel therapeutics, including through multi-node inhibition of critical oncogenic pathways. The Company's Chief Operating Decision Maker ("CODM"), the President, reviews the operating results on an aggregate basis and manages the operations as a single operating segment. The CODM oversees performance assessment and resource allocation by reviewing net loss, from our consolidated statement of operations, to guide operational decisions, strategic planning, and forecasting for future periods. To support this oversight, operating expenses are closely tracked to compare budget against actual results. As a single reporting segment, the significant operating expense categories regularly provided to the CODM include research and development, and general and administrative expenses. These expense categories are reported as separate line items in our consolidated statements of operations. All segment assets are reflected as 'total assets' in the consolidated balance sheet. All equipment, leasehold improvements, and fixed assets are located in the United States, and agreements with partners are denominated in U.S. dollars, unless otherwise noted.

***Emerging Growth Company Status***

The Company is an "emerging growth company," as defined in the Jumpstart Our Business Startups Act of 2012 ("the JOBS Act"), and may take advantage of reduced reporting requirements that are otherwise applicable to public companies. Section 107 of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies are required to comply with those standards. The Company has elected to use the extended transition period for complying with new or revised accounting standards unless otherwise stated.

The Company will remain an "emerging growth company" until the earliest of (i) December 31, 2026, (ii) the last day of the fiscal year in which it has total annual gross revenues of $1.235 billion or more, (iii) the date on which it has issued more than $1.0 billion in nonconvertible debt during the previous three years or (iv) the date on which it is deemed to be a large accelerated filer under the rules of the Securities and Exchange Commission ("SEC"), which generally is when it has more than $700 million in market value of its stock held by non-affiliates.

***Recently Adopted New Accounting Standard***

In December 2023, the Financial Accounting Standards Board ("FASB") issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which focuses on the rate reconciliation and income taxes paid. ASU No. 2023-09 requires a public business entity (PBE) to disclose, on an annual basis, a tabular rate reconciliation using both percentages and currency amounts, broken out into specified categories with certain reconciling items further broken out by nature and jurisdiction to the extent those items exceed a specified threshold. In addition, all entities are required to disclose income taxes paid, net of refunds received disaggregated by federal, state/local, and foreign and by jurisdiction if the amount is at least 5% of total income tax payments, net of refunds received. For PBEs, the new standard is effective for annual periods beginning after December 15, 2024, with early adoption

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permitted. For entities other than PBEs, the requirements will be effective for annual periods beginning after December 15, 2025. An entity may apply the amendments in this ASU prospectively by providing the revised disclosures for the period ending December 31, 2025 and continuing to provide the pre-ASU disclosures for the prior periods, or may apply the amendments retrospectively by providing the revised disclosures for all periods presented. For the year ended December 31, 2025, the Company early adopted this ASU retrospectively. The adoption only impacted the Company's income tax disclosures and had no impact on its results of operations, cash flows, or financial condition.

***Recently Issued Accounting Standards*** 

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." The standard is intended to require more detailed disclosures about specified categories of expenses (including employee compensation, depreciation, and amortization) included in certain expense captions presented on the face of the income statement. This ASU is effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to all prior periods presented in the financial statements. The Company is currently assessing the impact this standard will have on its consolidated financial statements.

**3. MARKETABLE SECURITIES**

Marketable securities consist of the following as of December 31, 2025 and 2024 (in thousands):

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **As of December 31, 2025** | **As of December 31, 2025** | **As of December 31, 2025** | **As of December 31, 2025** |
|  | **Amortized Cost** | **Unrealized Gains** | **Unrealized Losses** | **Fair Value** |
| Commercial paper | $9772 | $1 | $(1) | $9772 |
| Corporate bonds | 2743 | 1 |  | 2744 |
| Total | $12515 | $2 | $(1) | $12516 |

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **As of December 31, 2024** | **As of December 31, 2024** | **As of December 31, 2024** | **As of December 31, 2024** |
|  | **Amortized Cost** | **Unrealized Gains** | **Unrealized Losses** | **Fair Value** |
| Commercial paper | $25875 | $2 | $(16) | $25861 |
| Corporate bonds | 5479 | 2 | (1) | 5480 |
| Total | $31354 | $4 | $(17) | $31341 |

---

As of December 31, 2025, all marketable securities held by the Company had remaining contractual maturities of one year or less.

There were no impairments of the Company's assets measured and carried at fair value during the year ended December 31, 2025 and 2024.

As of December 31, 2025, an immaterial amount of unrealized losses were associated with marketable securities with contractual maturities of one year or less.

------

**4. 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 (in thousands):

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Fair value measurements at December 31, 2025** | **Fair value measurements at December 31, 2025** | **Fair value measurements at December 31, 2025** | **Fair value measurements at December 31, 2025** |
|  | **Level 1** | **Level 2** | **Level 3** | **Total** |
| Assets: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Cash equivalents: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp; Money market funds | $7896 | $— | $— | $7896 |
| &nbsp;&nbsp;&nbsp;&nbsp;Investments: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp; Commercial paper |  | 9772 |  | 9772 |
| &nbsp;&nbsp;&nbsp;&nbsp; Corporate bonds |  | 2744 |  | 2744 |
| Total | $7896 | $12516 | $— | $20412 |

---

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Fair value measurements at December 31, 2024** | **Fair value measurements at December 31, 2024** | **Fair value measurements at December 31, 2024** | **Fair value measurements at December 31, 2024** |
|  | **Level 1** | **Level 2** | **Level 3** | **Total** |
| Assets: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Cash equivalents: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp; Money market funds | $9220 | $— | $— | $9220 |
| &nbsp;&nbsp;&nbsp;&nbsp;Investments: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp; Commercial paper |  | 25861 |  | 25861 |
| &nbsp;&nbsp;&nbsp;&nbsp; Corporate bonds |  | 5480 |  | 5480 |
| Total | $9220 | $31341 | $— | $40561 |

---

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 among Level 1, Level 2 or Level 3 categories in the years ended December 31, 2025 and 2024.

**5. PROPERTY AND EQUIPMENT, NET** 

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

---

| | | |
|:---|:---|:---|
|  | **December 31,<br>2025** | **December 31,<br>2024** |
| Research equipment | $— | $1306 |
| Office equipment and furniture | 369 | 354 |
| Leasehold improvement | 253 | 253 |
| &nbsp;&nbsp;&nbsp;Total property and equipment | 622 | 1913 |
| Less accumulated depreciation and amortization | (540) | (1496) |
| Property and equipment, net | $82 | $417 |

---

Depreciation and amortization expense for the years ended December 31, 2025 and 2024 was $0.1 million and $0.6 million, respectively.

For the year ended December 31, 2025 the Company disposed of all research equipment through the sale of fixed assets, resulting in a reduction of the gross carrying amount to zero. The related accumulated depreciation of $1.1 million was written off in connection with this disposal. A gain of $42 thousand was recognized on the sale and is included in the other expense line in the consolidated statements of operations and comprehensive loss for the period.

------

For the year ended December 31, 2024, the Company recorded a charge of $0.4 million in the long-lived asset impairment line in the consolidated statements of operations and comprehensive loss, resulting from streamlining operations and focusing resources on advancing the clinical development of solnerstotug. This charge is comprised of gross write-downs of $0.9 million for research equipment and $0.2 million for office equipment and furniture, and the write-off of associated accumulated depreciation and amortization amounting to $0.6 million and $0.1 million for research equipment and office equipment and furniture, respectively. These amounts were removed from the balance sheet.

**6. COMMITMENTS AND CONTINGENCIES** 

***Operating Lease*** 

As of December 31, 2025, the Company leased office and laboratory facilities under operating leases, which expire at various dates through 2027. The Company had $678 thousand in letters of credit outstanding as security on certain of these leases. As part of its adoption of ASC 842, the Company recorded operating right-of-use assets and operating lease liabilities for these leases as of January 1, 2022.

The Company entered into an operating sublease agreement on January 18, 2023 (the "Sublease") with respect to part of its existing Boston office and laboratory facilities (the "Head Lease"). The Company accounted for the Head Lease and the Sublease as separate contracts and there was no effect on the right-of-use asset or lease liability associated with the Head Lease. The Sublease ended on December 31, 2024. The Head Lease rent expense is presented separately from income related to the Sublease and both are reported as components of operating expenses on the consolidated statements of operations and comprehensive loss. The Company recorded $0 and $385 thousand of income related to the Sublease for the years ended December 31, 2025 and 2024, respectively.

***Finance Leases***

The Company leases research equipment and furniture under finance leases.

The following table contains a summary of the lease costs recognized under ASC 842 pertaining to the Company's finance and operating leases (in thousands):

---

| | | |
|:---|:---|:---|
|  | **For the Twelve Months Ended December 31,** | **For the Twelve Months Ended December 31,** |
|  | **2025** | **2024** |
| Lease Cost: |  |  |
| &nbsp;&nbsp;&nbsp;Amortization of finance ROU assets | $17 | $771 |
| &nbsp;&nbsp;&nbsp;Interest on finance lease liabilities | 32 | 90 |
| &nbsp;&nbsp;&nbsp;Operating lease cost | 1672 | 1849 |
| &nbsp;&nbsp;&nbsp;Variable lease cost | 847 | 601 |
| Total lease costs | 2568 | 3311 |
| &nbsp;&nbsp;&nbsp;Operating Sublease income |  | (385) |
| Total lease costs, net | $2568 | $2926 |

---

During the year ended December 31, 2025, the Company disposed of research equipment classified as a ROU asset under a lease agreement. The ROU asset was sold, resulting in a loss of $43 thousand, which is included in the other expense line in the consolidated statements of operations and comprehensive loss for the period.

During the year ended December 31, 2024, the Company recognized impairment charges on certain finance right-of-use assets due to streamlining operations and focusing resources on advancing the clinical development of solnerstotug. These charges amounted to $0.6 million, which are not included in the regular amortization expense shown in the table above. The amount related to the right-of-use asset impairment is recorded in the long-lived asset impairment charges line in the consolidated statements of operations and comprehensive loss.

The following table contains a summary of other information pertaining to the Company's finance and operating leases (in thousands, except lease term and discount rate):

------

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **For the Twelve Months Ended December 31,** | **For the Twelve Months Ended December 31,** | **For the Twelve Months Ended December 31,** | **For the Twelve Months Ended December 31,** |
|  | **2025** | **2025** | **2024** | **2024** |
| Other Operating Lease Information: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Operating cash outflows for operating leases | $| 1748 | $| 1875 |
| &nbsp;&nbsp;&nbsp;Operating cash inflows for operating subleases | $|  | $| (401) |
| &nbsp;&nbsp;&nbsp;Operating cash outflows for finance leases | $| 32 | $| 90 |
| &nbsp;&nbsp;&nbsp;Financing cash outflows from finance leases | $| 790 | $| 811 |
| &nbsp;&nbsp;&nbsp;Weighted average remaining lease term |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Operating leases | 0.9 years | 0.9 years | 1.8 years | 1.8 years |
| &nbsp;&nbsp;&nbsp;Financing leases | 0.4 years | 0.4 years | 1.1 years | 1.1 years |
| &nbsp;&nbsp;&nbsp;Weighted average discount rate |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Operating leases | 7.6% | 7.6% | 7.7% | 7.7% |
| &nbsp;&nbsp;&nbsp;Financing leases | 9.4% | 9.4% | 8.6% | 8.6% |

---

The following table presents the maturity of the Company's operating and finance lease liabilities as of December 31, 2025 (in thousands):

---

| | | |
|:---|:---|:---|
|  | **Operating** | **Financing** |
| 2026 | $1413 | $81 |
| 2027 | 59 |  |
| Total future minimum lease payments | 1472 | 81 |
| Less amount representing interest | 43 | 1 |
| Total lease liabilities | $1429 | $80 |

---

***License Agreements*** 

In the normal course of business, the Company enters into licensing agreements with various parties to obtain the right to make, use, and sell licensed products currently in development.

***Litigation*** 

The Company records estimated losses from loss contingencies, such as a loss arising from a litigation, when it determines that it is probable a liability has been incurred and the amount of loss can be reasonably estimated. Litigation is subject to many factors that are difficult to predict so that there can be no assurance, in the event of a material unfavorable result in one or more claims, the Company will not incur material costs.

**7. ACCOUNTS PAYABLE AND CURRENT ACCRUED LIABILITIES**

Accounts payable and accrued liabilities consist of the following (in thousands):

---

| | | |
|:---|:---|:---|
|  | **December 31,<br>2025** | **December 31,<br>2024** |
| Accounts payable | $689 | $244 |
| Accrued expenses | 715 | 847 |
| Accrued restructuring (Note 14) |  | 31 |
| Other current liabilities | 77 | 126 |
| Total | $1481 | $1248 |

---

**8. Equity**

Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company's stockholders. Common stockholders are not entitled to receive dividends, unless declared by the board of directors.

***Common Stock Warrants***

------

There was no common stock warrant activity related to common stock warrants issued in conjunction with equity and debt fundraising events for the years ended December 31, 2025 and 2024. The following is a summary of the common stock warrants outstanding at December 31, 2025 and 2024:

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Number<br>of Common <br>Stock <br>Warrants** | **Weighted-<br>Average<br>Exercise<br>Price** | **Weighted-<br>Average<br>Remaining<br>Contractual<br>Term<br>(in years)** | **Aggregate<br>Intrinsic<br>Value (in<br>thousands)** |
| Outstanding at December 31, 2024 | 20609 | $195.80 | 2.70 | $— |
| &nbsp;&nbsp;&nbsp;Expired | (19466) | $79.00 |  |  |
| Outstanding at December 31, 2025 | 1143 | $2185.04 | 3.15 | $— |

---

**9. STOCK-BASED COMPENSATION** 

***2018 Equity Incentive Plan***

The Company's 2018 Stock Incentive Plan (the "2018 Plan"), provided for the Company to grant qualified incentive options, nonqualified options, stock grants and other stock-based awards to employees and non-employees to purchase the Company's common stock. Upon the effectiveness of the 2021 Plan, the Company ceased issuing new awards under the 2018 Plan.

***2021 Equity Incentive Plan***

The 2021 Plan became effective in February 2021. The 2021 Plan provides for the grant of incentive stock options to employees, including employees of any parent or subsidiary corporations, and for the grant of nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards and other forms of stock awards to employees, directors, and consultants, including employees and consultants of the Company's affiliates. The number of shares initially reserved for issuance under the 2021 Plan was 250,000 (5,000,000 prior to Reverse Stock Split), which began automatically increasing on January 1 of each calendar year, starting on January 1, 2022 through January 1, 2031, in an amount equal to 4.0% of the total number of shares of the Company's capital stock outstanding on the last day of the calendar month before the date of each automatic increase, or a lesser number of shares determined by the board of directors. As of December 31, 2025, 101,824 shares remained available for issuance pursuant to the 2021 Plan.

***2021 Employee Stock Purchase Plan***

The 2021 ESPP became effective in February 2021. A total of 16,666 shares (333,333 prior to Reverse Stock Split) of common stock were initially reserved for issuance under the 2021 ESPP, which will automatically increase on January 1 of each calendar year, beginning on January 1, 2022 through January 1, 2031, by an amount equal to 1.0% of the total shares of common stock outstanding on December 31st of the preceding calendar year. The purchase price of the shares under the 2021 ESPP are at 85% of the lower of the fair market value of the Company's common stock on the first trading day of the offering period or on the purchase date. As of December 31, 2025, the Company had issued 12,220 shares under the 2021 ESPP, and 60,237 shares were available to be issued under the same plan.

***Stock Options*** 

The Company has granted options to purchase shares of common stock to employees and nonexecutive directors pursuant to the 2021 Plan at a weighted average fair value of $7.17 per share and $9.78 per share during the years ended December 31, 2025 and 2024, respectively. The Company uses the Black-Scholes option-pricing model to estimate the fair value of the stock options on the applicable grant dates.

------

The following is a summary of the stock option award activity during the year ended December 31, 2025:

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Number<br>of Stock<br>Options** | **Weighted-<br>Average<br>Exercise<br>Price** | **Weighted-<br>Average<br>Remaining<br>Contractual<br>Term<br>(in years)** | **Aggregate<br>Intrinsic<br>Value<br>(in thousands)** |
| Outstanding at December 31, 2024 | 264741 | $95.96 | 7.22 | $41 |
| &nbsp;&nbsp;&nbsp;Granted | 47224 | $9.21 |  |  |
| &nbsp;&nbsp;&nbsp;Exercised | (395) | $6.40 |  |  |
| &nbsp;&nbsp;&nbsp;Forfeited | (11105) | $13.02 |  |  |
| &nbsp;&nbsp;&nbsp;Expired | (28221) | $133.22 |  |  |
| &nbsp;&nbsp;&nbsp;Outstanding at December 31, 2025 | 272244 | $80.56 | 6.98 | $138 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Vested or expected to vest as of December 31, 2025 | 272244 | $80.56 | 6.98 | $138 |
| &nbsp;&nbsp;&nbsp;Exercisable at December 31, 2025 | 203451 | $103.39 | 6.41 | $87 |

---

The aggregate intrinsic value of the outstanding stock option awards is calculated as the difference between the exercise price and the market price of the Company's common stock at December 31, 2025. The aggregate intrinsic value of stock options exercised in the year ended December 31, 2025 was $1 thousand and there were no option exercises for the year ended December 31, 2024.

The total fair value of options vested during the years ended December 31, 2025 and 2024 was $1.3 million and $3.3 million, respectively.

At December 31, 2025, there was approximately $0.6 million of unrecognized stock-based compensation expense associated with the stock options, which is expected to be recognized over a weighted-average period of 2.26 years.

At December 31, 2024, there was approximately $1.5 million of unrecognized stock-based compensation expense associated with the stock options, which is expected to be recognized over a weighted-average period of 1.62 years.

***Restricted Stock Units***

The Company has granted restricted stock units with service-based vesting conditions.

The following is a summary of the restricted stock unit activity during the year ended December 31, 2025:

---

| | | |
|:---|:---|:---|
|  | **Restricted Stock Units** | **Weighted-<br>Average<br>Grant Date Fair Value** |
| Unvested at December 31, 2024 | 4178 | $55.01 |
| &nbsp;&nbsp;&nbsp;&nbsp;Vested | (1768) | $61.07 |
| &nbsp;&nbsp;&nbsp;&nbsp;Forfeited | (274) | $38.03 |
| Unvested at December 31, 2025 | 2136 | $52.17 |

---

Pursuant to the 2021 Plan, the Company granted restricted stock units which vest annually over a period of one, two, three or four years.

At December 31, 2025, there was approximately $30 thousand of unrecognized stock-based compensation expense associated with the restricted stock units which is expected to be recognized over a weighted-average period of 0.81 years.

At December 31, 2024, there was approximately $0.1 million of unrecognized stock-based compensation expense associated with the restricted stock units which is expected to be recognized over a weighted-average period of 1.44 years.

***Common Stock Warrants*** 

The following is a summary of the common stock warrant activity during the years ended December 31, 2025:

------

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Number<br>of Common<br>Stock<br>Warrants** | **Weighted-<br>Average<br>Exercise<br>Price** | **Weighted-<br>Average<br>Remaining<br>Contractual<br>Term<br>(in years)** | **Aggregate<br>Intrinsic<br>Value (in<br>thousands)** |
| Outstanding and exercisable at December 31, 2024 | 229 | $217.49 | 2.98 | $— |
| Outstanding and exercisable at December 31, 2025 | 229 | $217.49 | 1.98 | $— |

---

As of December 31, 2025, there was no unrecognized stock-based compensation expense associated with the common stock warrants.

During the years ended December 31, 2025 and 2024, the Company utilized the Black-Scholes option-pricing model for estimating the fair value of the stock options and common stock warrants granted. The following table presents the assumptions and the Company's methodology for developing each of the assumptions used:

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| | | |
|:---|:---|:---|
|  | **For the Year Ended December 31,** | **For the Year Ended December 31,** |
|  | **2025** | **2024** |
| Volatility | 94%-96% | 91%-94% |
| Expected term (years) | 5.5-6.0 | 4.9-6.0 |
| Risk-free interest rate | 4.2%-4.4% | 3.8%–4.6% |
| Dividend rate | —% | —% |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Volatility—The Company lacks sufficient Company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies in addition to its own historical volatility and will continue to do so until it has adequate historical data regarding the volatility of its own traded stock price.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Expected term—The Company calculates the expected term of options using the simplified method, as the Company lacks relevant historical data due to the Company's limited operating experience.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Risk-free interest rate—The risk-free rate for periods within the estimated life of the stock award is based on the U.S. Treasury yield curve in effect at the time of grant.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Dividend rate—The assumed dividend yield is based upon the Company's expectation of not paying dividends in the foreseeable future.

Stock-based compensation expense was recorded in the following line items in the consolidated statements of operations (in thousands):

---

| | | |
|:---|:---|:---|
|  | **Year Ended December 31,** | **Year Ended December 31,** |
|  | **2025** | **2024** |
| Research and development | $358 | $846 |
| General and administrative | 916 | 2289 |
| Total stock-based compensation expense | $1274 | $3135 |

---

**10. EMPLOYEE RETIREMENT PLAN** 

The Company maintains a defined contribution 401(k) plan (the "Plan") for all employees. Under the Plan, participants may make voluntary contributions up to the maximum amount allowable by law. The Plan is based on employees' salary deferral, and the Company matches employees' contributions up to 4% of the employees' base salary. Employees are 100% vested in the Company's match contributions. During the years ended December 31, 2025 and 2024, the Company's matching contributions were $160 thousand and $238 thousand, respectively.

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**11. COMPENSATION AND EMPLOYEE BENEFITS**

Compensation and employee benefits consist of the following (in thousands):

---

| | | |
|:---|:---|:---|
|  | **December 31,<br>2025** | **December 31,<br>2024** |
| Accrued incentive compensation | $111 | $1379 |
| Accrued restructuring - compensation (Note 14) | 1159 | 445 |
| Other compensation related liabilities | 50 | 58 |
| Total | $1320 | $1882 |

---

**12. INCOME TAXES** 

The components of net loss before income tax expense are as follows (in thousands):

---

| | | |
|:---|:---|:---|
|  | **December 31,<br>2025** | **December 31,<br>2025** |
|  | **2025** | **2024** |
| Domestic | $(21085) | $(30157) |
| Foreign |  |  |
| Total | $(21085) | $(30157) |

---

Income tax expense consists of the following (in thousands):

---

| | | |
|:---|:---|:---|
|  | **Year Ended December 31,** | **Year Ended December 31,** |
|  | **2025** | **2024** |
| Current: |  |  |
| &nbsp;&nbsp;&nbsp;Federal | $— | $— |
| &nbsp;&nbsp;&nbsp;State |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Current tax provision |  |  |
| Deferred: |  |  |
| &nbsp;&nbsp;&nbsp;Federal | (3414) | (5559) |
| &nbsp;&nbsp;&nbsp;State | 795 | (1627) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Deferred tax benefit | (2619) | (7186) |
| Less change in valuation allowance | 2619 | 7186 |
| Total income tax provision | $— | $— |

---

The components of the Company's loss before income tax expense is comprised solely of domestic sources. The effective income tax rate for the years ended December 31, 2025 and 2024 was different from the federal statutory income tax rate primarily due to the change in valuation allowance against deferred tax assets and permanent differences primarily related to equity based compensation. The reconciliation of the federal statutory income tax rate to the Company's effective income tax rate is as follows:

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Year Ended December 31,** | **Year Ended December 31,** | **Year Ended December 31,** | **Year Ended December 31,** |
|  | **2025** | **2025** | **2024** | **2024** |
|  | Amount | Percent | Amount | Percent |
| Pretax Loss | $(21085) |  | $(30157) |  |
| US federal statutory tax rate | (4428) | 21% | (6333) | 21% |
| State and local income taxes, net of federal benefit |  | 0.0% |  | 0.0% |
| Change in valuation allowance | 3414 | -16.2% | 5559 | -18.4% |
| Nontaxable or nondeductible items: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Equity-based compensation | 399 | -1.9% | 343 | -1.1% |
| &nbsp;&nbsp;&nbsp;&nbsp;Other | 10 | 0.0% | 42 | -0.2% |
| Other adjustments: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Net operating loss expiration | 605 | -2.9% | 389 | -1.3% |
| Total | $- | 0% | $- | 0% |

---

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The Company's effective tax rate differs from the statutory rate primarily due to continued losses and the maintenance of a full valuation allowance on deferred tax assets, resulting in zero income tax expense for the period.

Significant components of the Company's deferred tax assets and liabilities consist of the following (in thousands):

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| | | |
|:---|:---|:---|
|  | **December 31,** | **December 31,** |
|  | **2025** | **2024** |
| Net operating loss carryforwards | $42095 | $37026 |
| Equity-based compensation | 3353 | 3815 |
| Research and development tax credit carryforwards | 1364 | 1364 |
| Capitalized R&D expenditures | 13241 | 14889 |
| Lease liabilities | 379 | 896 |
| Other accruals | 706 | 1038 |
| &nbsp;&nbsp;&nbsp;Total deferred tax assets | $61138 | $59028 |
| Valuation allowance | (60796) | (58180) |
| Net deferred tax assets | $342 | $848 |
| Deferred tax liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Right-of-use assets | $(342) | $(848) |
| &nbsp;&nbsp;&nbsp;&nbsp;Total deferred tax liabilities | $(342) | $(848) |
| &nbsp;&nbsp;&nbsp;&nbsp;Net deferred tax assets (liability) | $— | $— |

---

As of December 31, 2025, the Company has net operating loss carryforwards for federal and state tax reporting purposes of $170.5 million and $98.9 million, respectively, a portion of which expired beginning in 2025. Net operating loss carryforwards generated after December 31, 2017 for federal tax reporting purposes of $137.2 million have an indefinite life. The remaining federal net operating losses are subject to a 20-year carryforward period. As of December 31, 2025, the Company has research and development tax credit carryforwards of approximately $1.4 million, which expire beginning in 2034.

The utilization of NOLs and tax credit carryforwards to offset future taxable income may be subject to an annual limitation as a result of ownership changes that have occurred previously or may occur in the future. Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, ("IRC"), a corporation that undergoes an ownership change may be subject to limitations on its ability to utilize its pre-change NOLs and other tax attributes otherwise available to offset future taxable income and/or tax liability. An ownership change is defined as a cumulative change of 50% or more in the ownership positions of certain stockholders during a rolling three-year period. The Company has not completed a formal study to determine if any ownership changes within the meaning of IRC Section 382 and 383 have occurred as of December 31, 2025. An ownership change would restrict its ability to use its NOLs or tax credit carryforwards and could require the Company to pay federal or state income taxes earlier than would be required if such limitations were not in effect.

For tax years beginning after December 31, 2024, OBBBA ("One Big Beautiful Bill Act") enacted a new rule under Section 174A allowing companies to immediately expense any domestic research and developmental ("R&D") expenditures. For domestic R&D, companies may either immediately expense or elect to capitalize and amortize over at least 60 months under Section 174A. However, foreign R&D continues to require capitalization subject to the mandatory 15-year amortization period under Section 174.

The Company has elected to continue amortizing the previously capitalized costs over their remaining life. Beginning in tax year 2025, instead of immediately expensing domestic R&D expenditures under Section 174A, the Company elected to capitalize and amortize its domestic R&D expenditures under Section 59(e) over a 10 year period. Any foreign R&D costs will continue to be capitalized and amortized over 15 years in accordance with the requirements of Section 174.

A valuation allowance is required to be established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain. The Company has reviewed its positive and negative evidence and has concluded that it is more likely than not that the net deferred tax assets will not be realized; therefore, the Company continues to maintain a valuation allowance. The Company's valuation allowance increased by $2.6 million for the year ended December 31, 2025, primarily due to the generation of net operating losses.

The Company evaluates its uncertain tax positions under ASC 740-10, which requires that realization of an uncertain income tax position be recognized in the financial statements. The benefit to be recorded in the financial statements is the amount most likely to be realized assuming a review by tax authorities having all relevant information and applying current conventions. The Company concluded that there are no uncertain tax positions in any of the periods presented.

------

The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. The earliest tax years that remain subject to examination by jurisdiction is 2022 for both federal and state. However, to the extent the Company utilizes net operating losses from years prior to 2022, the statute remains open to the extent of the net operating losses or other credits are utilized.

**13. NET LOSS PER SHARE** 

Basic and diluted net loss per share attributable to common stockholders is calculated as follows (in thousands except share and per share amounts):

---

| | | |
|:---|:---|:---|
|  | **For the Twelve Months Ended December 31,** | **For the Twelve Months Ended December 31,** |
|  | **2025** | **2024** |
| Net loss | $(21085) | $(30157) |
| Net loss per share—basic and diluted | $(16.72) | $(24.01) |
| Weighted-average number of shares used in computing net loss per share—basic and diluted | 1260772 | 1255776 |

---

The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per share, as their effect is anti-dilutive:

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| | | |
|:---|:---|:---|
|  | **For the Year Ended December 31,** | **For the Year Ended December 31,** |
|  | **2025** | **2024** |
| Stock options to purchase common stock | 272244 | 264741 |
| Unvested restricted stock units | 2136 | 4178 |
| Warrants issued to employees and contractor to purchase common stock | 229 | 229 |
| Warrants issued related to convertible notes and other equity agreements | 1143 | 20609 |

---

**14. RESTRUCTURING AND RELATED CHARGES**

In November 2024, the Company announced a restructuring initiative to streamline operations and focus resources on advancing the clinical development of solnerstotug (the "2024 Restructuring"). As part of the 2024 Restructuring, the Company closed its research site in Rockville, Maryland, and reduced its workforce by approximately 46%, with the majority of reductions occurring in the preclinical research and development group. These actions were intended to extend the Company's cash runway.

In October 2025, the Company announced it was exploring strategic alternatives. In November 2025, the Company's Board of Directors approved a reduction in force of approximately 65% of the Company's workforce (together with the October 2025 actions, the "2025 Restructuring") to preserve capital while the Company evaluated potential mergers, asset sales, or other strategic transactions.

The 2024 Restructuring and 2025 Restructuring costs are primarily related to one-time termination benefits and ongoing benefit arrangements, both of which included severance payments and extended benefits coverage. Aggregate costs also included certain contract termination costs.

The following table summarizes the accrued liabilities activity recorded in connection with the 2024 Restructuring and 2025 Restructuring as of December 31, 2025 (in thousands):

------

---

| | | | |
|:---|:---|:---|:---|
|  | **Personnel** | **Other** | **Total** |
| Balance at January 1, 2024 | $— | $— | $— |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Restructuring and other costs | 723 | 31 | 754 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Cash payments | (278) |  | (278) |
| Balance at December 31, 2024 | 445 | 31 | 476 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Restructuring and other costs, net | 25 | (2) | 23 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Cash payments | (346) | (16) | (362) |
| Balance at March 31, 2025 | 124 | 13 | 137 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Restructuring and other costs, net |  | (3) | (3) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Cash payments | (124) | (6) | (130) |
| Balance at June 30, 2025 |  | 4 | 4 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Restructuring and other costs, net |  | (4) | (4) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Cash payments |  |  |  |
| Balance at September 30, 2025 |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Restructuring and other costs, net | 1671 |  | 1671 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Cash payments | (512) |  | (512) |
| Balance at December 31, 2025 | $1159 | $— | $1159 |

---

**15. SUBSEQUENT EVENTS**

*Merger Agreement and Private Placement*

On February 17, 2026, the Company acquired Faeth Holdings Therapeutics, Inc. ("Faeth HoldCo") and its wholly owned subsidiary Faeth Therapeutics, LLC ("Faeth Subsidiary" and, together with Faeth HoldCo, "Faeth Therapeutics") pursuant to an Agreement and Plan of Merger (the "Merger Agreement"), dated as of February 17, 2026, by and among the Company, its merger subsidiaries, Faeth HoldCo and Faeth Subsidiary. The acquisition was structured as a stock-for-stock transaction pursuant to which all of Faeth HoldCo's outstanding shares of capital stock were exchanged based on a fixed exchange ratio for 10,497.0980 shares of Series B Non-Voting Convertible Preferred Stock (representing 10,497,098 shares on an as-converted-to-common basis and without giving effect to any beneficial ownership limitations), (ii) the outstanding warrant to purchase shares of Faeth Subsidiary capital stock was converted into a warrant to purchase an aggregate of 2.1020 shares of Series B Non-Voting Preferred Stock (representing a warrant to purchase 2,102 shares of Common Stock on an as-converted-to-common basis and without giving effect to any beneficial ownership limitations) and (iii) all outstanding options to purchase Faeth Subsidiary common stock were assumed by the Company and converted into options to purchase an aggregate of 252,210 shares of Common Stock. While the Company continues to evaluate the accounting for the transaction, the Company currently expects to account for it as an asset acquisition.

Concurrently with the acquisition of Faeth Therapeutics, the Company entered into a definitive agreement for a private placement financing with new and returning investors to raise $200 million of gross proceeds in which the investors were issued an aggregate of 14,440.395 shares of Series B Non-Voting Convertible Preferred Stock (or 14,440,395 on an as-converted-to-common basis and without giving effect to any beneficial ownership limitations) at a price of approximately $13,850 per share (or approximately $13.85 per share on an as-converted-to-common basis). The private placement financing closed on February 20, 2026.

Subject to the receipt of stockholder approval of the Parent Stockholder Matters (as defined in the Merger Agreement), each share of Series B Non-Voting Convertible Preferred Stock will automatically convert into 1,000 shares of Common Stock, subject to certain beneficial ownership limitations established by each holder. As a result of the transactions, equityholders of the Company immediately prior to the acquisition owned approximately 4.9% of the Common Stock, equityholders of Faeth Therapeutics immediately prior to the acquisition owned approximately 40.6% of the Common Stock and investors in the private placement financing owned approximately 54.5% of the Common Stock, in each case, calculated on a fully-diluted, as-converted-to-common basis (and without giving effect to any beneficial ownership limitations) using the treasury stock method and based on the implied equity values of the Company and Faeth Therapeutics.

------

## Exhibit 4.1

**Exhibit 4.1**

**DESCRIPTION OF SENSEI BIOTHERAPEUTICS, INC. CAPITAL STOCK**

*The following description of the capital stock of Sensei Biotherapeutics, Inc. (the "Company," "we," "us" or "our") is a summary and does not purport to be complete. This summary is qualified in its entirety by reference to the provisions of the Delaware General Corporation Law (the "DGCL"), and the complete text of our amended and restated certificate of incorporation (our "certificate of incorporation") and our amended and restated bylaws (our "bylaws") which, along with amendments to our certificate of incorporation, are incorporated by reference as Exhibits 3.1, 3.2, 3.3, 3.4 and 3.5 of the Company's Annual Report on Form 10-K to which this description is also an exhibit. The Company encourages you to read that law and those documents carefully.*

**General**

Under our certificate of incorporation, our authorized capital stock consists of 12,500,000 shares of common stock, $0.0001 par value per share ("common stock"), and 10,000,000 shares of preferred stock, $0.0001 par value per share ("preferred stock"), 15,045 shares of which are undesignated and 25,045 shares of which are designated as Series B Non-Voting Convertible Preferred Stock. Our board of directors may establish the rights and preferences of the undesignated preferred stock from time to time.

**Common Stock**

***Voting Rights***

Holders of our common stock are entitled to one vote per share of common stock. Our common stock does not have cumulative voting rights. Accordingly, the holders of a majority of the outstanding shares of common stock entitled to vote in any election of directors can elect all of the directors standing for election, if they so choose, other than any directors that holders of any preferred stock we may issue may be entitled to elect.

***Dividends***

Subject to preferences that may be applicable to any then outstanding preferred stock, holders of our common stock are entitled to receive ratably those dividends, if any, as may be declared by our board of directors out of legally available funds.

***Liquidation***

In the event of our liquidation, dissolution or winding up, the holders of our common stock will be entitled to share ratably in the assets legally available for distribution to stockholders after the payment of or provision for all of our debts and other liabilities, subject to the prior rights of any preferred stock then outstanding.

***Rights and Preferences***

Holders of our common stock have no preemptive rights or other subscription rights and there are no redemption or sinking funds provisions applicable to our common stock. All outstanding shares of our common stock are duly authorized, validly issued, fully paid and nonassessable. The rights, preferences and privileges of holders of our common stock are subject to and may be adversely affected by the rights of the holders of shares of any series of preferred stock that we may designate and issue in the future.

**Preferred Stock**

Under the terms of our certificate of incorporation, our board of directors has the authority, without further action by our stockholders, to issue up to 10,000,000 shares of preferred stock in one or more series, to establish from time to time the number of shares to be included in each such series, to fix the dividend, voting and other rights, preferences and privileges of the shares of each wholly unissued series and any qualifications, limitations or

------

**Exhibit 4.1**

restrictions thereon, and to increase or decrease the number of shares of any such series, but not below the number of shares of such series then outstanding.

Our board of directors may authorize the issuance of preferred stock with voting or conversion rights that could adversely affect the voting power or other rights of the holders of the common stock. The issuance of preferred stock, while providing flexibility in connection with possible acquisitions and other corporate purposes, could, among other things, have the effect of delaying, deferring or preventing a change in our control and may adversely affect the market price of the common stock and the voting and other rights of the holders of common stock. We have no current plans to issue any shares of preferred stock.

***Preferred Stock Purchase Rights***

On March 7, 2023, a special committee of the board of directors adopted a stockholder rights plan and declared a dividend of one right (a "Right") for each outstanding share of common stock of the Company. Each Right entitled the registered holder thereof under certain circumstances to purchase from the Company one ten-thousandth of a share of Series A Junior Participating Cumulative Preferred Stock. The terms of the Rights were set forth in a Stockholder Rights Agreement, dated as of March 7, 2023, between the Company and American Stock Transfer & Trust Company, LLC, as rights agent (as amended, the "Rights Agreement").

The Rights expired pursuant to the terms of the Rights Agreement on March 7, 2025. Accordingly, on March 26, 2025, the Company filed with the Secretary of State of the State of Delaware a Certificate of Elimination eliminating from its Amended and Restated Certificate of Incorporation, as amended, the designation of certain shares of its preferred stock as Series A Junior Participating Cumulative Preferred Stock, which had been designated for potential use in connection with the Rights Agreement. As a result, all shares of preferred stock previously designated as Series A Junior Participating Cumulative Preferred Stock were eliminated and returned to the status of authorized but unissued shares of preferred stock, without designation.

***Series B Non-Voting Convertible Preferred Stock***

On February 17, 2026, the Company filed with the Secretary of State of the State of Delaware a Certificate of Designation of Preferences, Rights and Limitations of Series B Non-Voting Convertible Preferred Stock (the "Certificate of Designation"), which designated 25,045 shares of undesignated preferred stock as "Series B Non-Voting Convertible Preferred Stock." Each share of Series B Non-Voting Convertible Preferred Stock is convertible into 1,000 shares of Common Stock, subject to and in accordance with the terms and conditions of the Certificate of Designation.

**Anti-Takeover Effects of Delaware Law and Our Certificate of Incorporation and Bylaws**

Some provisions of Delaware law, our certificate of incorporation and our bylaws contain provisions that could make the following transactions more difficult: an acquisition of us by means of a tender offer; an acquisition of us by means of a proxy contest or otherwise; or the removal of our incumbent officers and directors. It is possible that these provisions could make it more difficult to accomplish or could deter transactions that stockholders may otherwise consider to be in their best interest or in our best interests, including transactions which provide for payment of a premium over the market price for our shares.

These provisions, summarized below, are intended to discourage coercive takeover practices and inadequate takeover bids. These provisions are also designed to encourage persons seeking to acquire control of us to first negotiate with our board of directors. We believe that the benefits of the increased protection of our potential ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure us outweigh the disadvantages of discouraging these proposals because negotiation of these proposals could result in an improvement of their terms.

***Stockholder Meetings***

Our bylaws provide that a special meeting of stockholders may be called only by our chairman of the board, chief executive officer or president, or by a resolution adopted by a majority of our board of directors.

------

**Exhibit 4.1**

***Requirements for Advance Notification of Stockholder Nominations and Proposals***

Our bylaws establish advance notice procedures with respect to stockholder proposals to be brought before a stockholder meeting and the nomination of candidates for election as directors, other than nominations made by or at the direction of the board of directors or a committee of the board of directors.

***Elimination of Stockholder Action by Written Consent***

Our certificate of incorporation and bylaws eliminate the right of stockholders to act by written consent without a meeting.

***Staggered Board***

Our board of directors is divided into three classes. The directors in each class serve for a three-year term, one class being elected each year by our stockholders. This system of electing and removing directors may tend to discourage a third-party from making a tender offer or otherwise attempting to obtain control of us, because it generally makes it more difficult for stockholders to replace a majority of the directors.

***Removal of Directors***

Our certificate of incorporation provides that no member of our board of directors may be removed from office by our stockholders except for cause and, in addition to any other vote required by law, upon the approval of not less than two thirds of the total voting power of all of our outstanding voting stock then entitled to vote in the election of directors.

***Stockholders Not Entitled to Cumulative Voting***

Our certificate of incorporation does not permit stockholders to cumulate their votes in the election of directors. Accordingly, the holders of a majority of the outstanding shares of our common stock entitled to vote in any election of directors can elect all of the directors standing for election, if they choose, other than any directors that holders of our convertible preferred stock may be entitled to elect.

***Delaware Anti-Takeover Statute***

We are subject to Section 203 of the DGCL, which prohibits persons deemed to be "interested stockholders" from engaging in a "business combination" with a publicly held Delaware corporation for three years following the date these persons become interested stockholders unless the business combination is, or the transaction in which the person became an interested stockholder was, approved in a prescribed manner or another prescribed exception applies. Generally, an "interested stockholder" is a person who, together with affiliates and associates, owns, or within three years prior to the determination of interested stockholder status did own, 15% or more of a corporation's voting stock. Generally, a "business combination" includes a merger, asset or stock sale, or other transaction resulting in a financial benefit to the interested stockholder. The existence of this provision may have an anti-takeover effect with respect to transactions not approved in advance by the board of directors.

***Choice of Forum***

Our certificate of incorporation provides that the Court of Chancery of the State of Delaware (or, if and only if the Court of Chancery of the State of Delaware lacks subject matter jurisdiction, any state court located within the State of Delaware or, if and only if all such state courts lack subject matter jurisdiction, the federal district court for the District of Delaware) and any appellate court therefrom is the sole and exclusive forum for the following claims or causes of action under the Delaware statutory or common law: (i) any derivative claim or cause of action brought on our behalf; (ii) any claim or cause of action for a breach of fiduciary duty owed by any of our current or former directors, officers, or other employees to us or our stockholders; (iii) any claim or cause of action against us or any of our current or former directors, officers or other employees arising out of or pursuant to any provision of the DGCL, our certificate of incorporation, or our bylaws (as each may be amended from time to time); (iv) any claim or cause of action seeking to interpret, apply, enforce or determine the validity of our certificate of incorporation or our bylaws (as each may be amended from time to time, including any right, obligation, or remedy thereunder); (v)

------

**Exhibit 4.1**

Securities Act. Additionally, our certificate of incorporation provides that any person or entity holding, owning or otherwise acquiring any interest in any of our securities shall be deemed to have notice of and consented to these provisions.

***Amendment of Certificate of Incorporation Provisions***

The amendment of any of the above provisions, except for the provision making it possible for our board of directors to issue convertible preferred stock, would require approval by holders of at least two thirds of the total voting power of all of our outstanding voting stock.

The provisions of Delaware law, our certificate of incorporation and our bylaws could have the effect of discouraging others from attempting hostile takeovers and, as a consequence, they may also inhibit temporary fluctuations in the market price of our common stock that often result from actual or rumored hostile takeover attempts. These provisions may also have the effect of preventing changes in the composition of our board of directors and management. It is possible that these provisions could make it more difficult to accomplish transactions that stockholders may otherwise deem to be in their best interests.

**Transfer Agent and Registrar**

The transfer agent and registrar for our common stock is Equiniti Trust Company, LLC. The transfer agent's address is 28 Liberty Street, Floor 53, New York, NY 10005.

**Exchange Listing**

Our common stock is listed on the Nasdaq Capital Market under the symbol "SNSE".

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## Exhibit 4.2

Exhibit 4.2

**THIS WARRANT AND THE SHARES ISSUABLE HEREUNDER HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, AND MAY NOT BE SOLD, PLEDGED, OR OTHERWISE TRANSFERRED WITHOUT AN EFFECTIVE REGISTRATION THEREOF UNDER SUCH ACT OR PURSUANT TO RULE 144 OR AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE CORPORATION AND ITS COUNSEL, THAT SUCH REGISTRATION IS NOT REQUIRED.**

**WARRANT TO PURCHASE STOCK**

---

| | |
|:---|:---|
| **Issuer:** | Faeth Therapeutics, Inc., a Delaware corporation |
| **Number of Shares:** | As set forth in Paragraph A below |
| **Class of Stock:** | Series Seed-3 Preferred Stock, $0.0001 par value per share |
| **Exercise Price:** | $1.42177 per Share, subject to adjustment |
| **Issue Date:** | September 7, 2021 |
| **Expiration Date:** | September 6, 2031 |

---

**THIS WARRANT CERTIFIES THAT**, for the agreed upon value of $1.00 and for other good and valuable consideration, **WESTERN ALLIANCE BANK**, or its assignees (*"***Holder***"*) is entitled to purchase up to the number of fully paid and non-assessable shares of the above-stated Class of the above-stated Company's capital stock (the "**Class**") determined pursuant to Paragraph A below, at the exercise price per Share set forth above (the "**Exercise Price**"), as the same may be from time to time adjusted pursuant to Article 2 hereof and subject to the provisions and upon the terms and conditions set forth in this Warrant.

**A.** <u>Number of Shares.</u> This Warrant shall be exercisable for the Initial Shares, plus the Additional Shares, if any (collectively, and as may be adjusted from time to time in accordance with the provisions of this Warrant, the "**Shares**").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) <u>Initial Shares.</u> As used herein, "**Initial Shares**" means 21,100 shares of the Class, subject to adjustment from time to time in accordance with the provisions of this Warrant.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) <u>Additional Shares.</u> Upon the making, if any, of each Term Loan Advance (as defined in the Loan Agreement) to the Company, this Warrant automatically shall become exercisable for such number of additional shares of the Class (cumulatively and collectively, and as may be adjusted from time to time in accordance with the provisions of this Warrant, the "**Additional Shares**") as shall equal (a)(i) 0.01, multiplied by (ii) the amount of such Term Loan Advance, divided by (b) the Exercise Price in effect on and as of the date of such Term Loan Advance, subject to adjustment thereafter from time to time in accordance with the provisions of this Warrant.

**ARTICLE 1. EXERCISE.**

**1.1 Method of Exercise.** This Warrant is exercisable, in whole or in part, at any time and from time to time on or before the Expiration Date set forth above. Holder may exercise this Warrant by delivering a duly executed Notice of Exercise, in substantially the form attached hereto as Appendix 1, to the principal office of the Company. Unless Holder is exercising by net issuance as set forth in Section 1.2, Holder shall also deliver to the Company an amount equal to the aggregate Exercise Price for Shares being purchased, by check or wire.

------

Exhibit 4.2

**1.2 Net Issuance.** The purchase price may be paid at the Holder's election either (i) by cash or check, or (ii) by surrender of all or a portion of the Warrant for shares of the Shares to be exercised under this Warrant and, if applicable, an amended Warrant representing the remaining number of Shares purchasable hereunder, as determined below ("**Net Issuance**"). If the Holder elects the Net Issuance method, the Company will issue Shares in accordance with the following formula:

**X = Y(A-B)**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**A**

Where:

---

| | |
|:---|:---|
| **X =** | the number of shares of Shares to be issued to the Holder. |
| **Y =** | the number of shares of Shares requested to be exercised under this Warrant (including Shares surrendered in payment of the aggregate Exercise Price) |
| **A =** | the fair market value of one (1) Share at the time of exercise. The fair market value of a Share shall be determined pursuant to Section 1.3. |
| **B =** | the Exercise Price. |

---

Upon partial exercise by either cash or Net Issuance, the Company shall promptly issue an amended Warrant representing the remaining number of shares purchasable hereunder. All other terms and conditions of such amended Agreement shall be identical to those contained herein, including, but not limited to the Effective Date hereof.

**1.3 Fair Market Value.** If the Company's common stock is then traded or quoted on a nationally recognized securities exchange, inter-dealer quotation system or over-the-counter market (a "**Trading Market**") and the Class is common stock, the fair market value of a Share shall be the closing price or last sale price of a share of common stock reported for the Business Day immediately before the date on which Holder delivers this Warrant together with its Notice of Exercise to the Company. If the Company's common stock is then traded in a Trading Market and the Class is a series of the Company's convertible preferred stock, the fair market value of a Share shall be the closing price or last sale price of a share of the Company's common stock reported for the Business Day immediately before the date on which Holder delivers this Warrant together with its Notice of Exercise to the Company multiplied by the number of shares of the Company's common stock into which a Share is then convertible. If the Company's common stock is not traded in a Trading Market, the Board of Directors of the Company shall determine the fair market value of a Share in its reasonable good faith judgment.

**1.4 Delivery of Certificate and New Warrant.** Promptly (and in no event more than 3 business days after exercise) after Holder exercises this Warrant, the Company shall deliver to Holder certificates (or evidence of book entry) for the Shares acquired and, if this Warrant has not been fully exercised and has not expired, a new warrant of like tenor representing the Shares not so acquired (or surrendered in payment of the aggregate Exercise Price).

**1.5 Replacement of Warrant.** On receipt of evidence reasonably satisfactory to the Company of the loss, theft, destruction or mutilation of this Warrant and, in the case of loss, theft or destruction, on delivery of an indemnity agreement reasonably satisfactory in form and amount to the Company or, in the case of mutilation, on surrender and cancellation of this Warrant, the Company at its expense shall execute and deliver a replacement Warrant.

**1.6 Sale, Merger, or Consolidation of Company.**

------

Exhibit 4.2

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)** <u>Acquisition.</u> For the purpose of this Warrant, "**Acquisition**" means any transaction or series of related transactions involving: (i) the sale, lease, exclusive license, or other disposition of all or substantially all of the assets of the Company (ii) any merger or consolidation of the Company into or with another person or entity (other than a merger or consolidation effected exclusively to change the Company's domicile), or any other corporate reorganization, in which the stockholders of the Company in their capacity as such immediately prior to such merger, consolidation or reorganization, own less than a majority of the Company's (or the surviving or successor entity's) outstanding voting power immediately after such merger, consolidation or reorganization (or, if such Company stockholders beneficially own a majority of the outstanding voting power of the surviving or successor entity as of immediately after such merger, consolidation or reorganization, such surviving or successor entity is not the Company); or (iii) any sale or other transfer by the stockholders of the Company of shares representing at least a majority of the Company's then-total outstanding combined voting power.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** <u>Treatment of Warrant at Acquisition.</u> In the event of an Acquisition in which the consideration to be received by the Company's stockholders consists solely of cash, solely of Marketable Securities or a combination of cash and Marketable Securities (a "**Cash/Public Acquisition**"), either (i) Holder shall exercise this Warrant pursuant to Section 1.1 and/or 1.2 and such exercise will be deemed effective immediately prior to and contingent upon the consummation of such Acquisition or (ii) if Holder elects not to exercise the Warrant, this Warrant will expire immediately prior to the consummation of such Acquisition.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c)** The Company shall provide Holder with written notice of its request relating to the Cash/Public Acquisition (together with such reasonable information as Holder may reasonably require regarding the treatment of this Warrant in connection with such contemplated Cash/Public Acquisition giving rise to such notice), which is to be delivered to Holder not less than seven (7) Business Days prior to the closing of the proposed Cash/Public Acquisition. In the event the Company does not provide such notice, then if, immediately prior to the Cash/Public Acquisition, the fair market value of one Share (or other security issuable upon the exercise hereof) as determined in accordance with Section 1.3 above would be greater than the Exercise Price in effect on such date, then this Warrant shall automatically be deemed on and as of such date to be exercised pursuant to Section 1.2 above as to all Shares (or such other securities) for which it shall not previously have been exercised, and the Company shall promptly notify the Holder of the number of Shares (or such other securities) issued upon such exercise to the Holder and Holder shall be deemed to have restated each of the representations and warranties in Section 4 of the Warrant as the date thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(d)** Upon the closing of any Acquisition other than a Cash/Public Acquisition defined above, the acquiring, surviving or successor entity shall assume the obligations of this Warrant, and this Warrant shall thereafter be exercisable for the same securities and/or other property as would have been paid for the Shares issuable upon exercise of the unexercised portion of this Warrant as if such Shares were outstanding on and as of the closing of such Acquisition, subject to further adjustment from time to time in accordance with the provisions of this Warrant.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(e)** As used in this Warrant, "**Marketable Securities**" means securities meeting all of the following requirements: (i) the issuer thereof is then subject to the reporting requirements of Section 13 or Section 15(d) of the Securities Exchange Act of 1934, as amended (the "**Exchange Act**"), and is then current in its filing of all required reports and other information under the Securities Act of 1933, as amended (the "**Act**") and the Exchange Act; (ii) the class and series of shares or other security of the issuer that would be received by Holder in connection with the Acquisition were Holder to exercise this Warrant on or prior to the closing thereof is then traded in a Trading Market, and (iii) following the closing of such Acquisition, Holder would not be restricted from publicly re-selling all of the issuer's shares and/or other securities that would be received by Holder in such Acquisition were Holder to exercise or convert this Warrant in full on or prior to the closing of such Acquisition.

------

Exhibit 4.2

**1.7 Automatic Cashless Exercise upon Expiration.** In the event that, upon the Expiration Date or other termination of this Warrant, the fair market value of one Share (or other security issuable upon the exercise hereof) as determined in accordance with Section 1.3 above is greater than the Exercise Price in effect on such date, then this Warrant shall automatically be deemed on and as of such date to be exercised pursuant to Section 1.2 above as to all Shares (or such other securities) for which it shall not previously have been exercised, and the Company shall, within a reasonable time, deliver a certificate (or evidence of book entry) representing the Shares (or such other securities) issued upon such exercise to Holder.

**ARTICLE 2. ADJUSTMENTS.**

**2.1 Stock Dividends, Splits, Etc.** If the Company declares or pays a dividend on the outstanding shares of the Class payable in additional shares of the Class or other securities or property (other than cash), or subdivides the outstanding shares of the Class into a greater number of shares, then upon exercise of this Warrant, for each Share acquired, Holder shall receive, without additional cost to Holder, the total number and kind of securities and other property to which Holder would have been entitled had Holder owned the Shares on the record date the dividend or subdivision occurred since the original issue date of this Warrant.

**2.2 Reclassification, Recapitalization, Exchange or Substitution.** Upon any reclassification, recapitalization, exchange, substitution, or other event that results in a change of the number and/or class of the securities issuable upon exercise or conversion of this Warrant, Holder shall be entitled to receive, upon exercise or conversion of this Warrant, the number and kind of securities and property that Holder would have received for Shares if this Warrant had been exercised immediately before such reclassification, recapitalization, exchange, substitution, or other event. The Company or its successor shall promptly issue to Holder a new warrant of like tenor for such new securities or other property. The new warrant shall provide for adjustments which shall be as nearly equivalent as may be practicable to the adjustments provided for in this Article 2 including, without limitation, adjustments to the Exercise Price. Class and number of securities or property issuable upon exercise of the new warrant. The provisions of this Section 2.2 shall similarly apply to successive reclassifications, recapitalizations, exchanges, substitutions, or other events.

**2.3 Adjustments for Combinations, Etc.** If the outstanding shares of the Class are combined or consolidated, by reclassification or otherwise, into a lesser number of shares, the Exercise Price shall be proportionately increased and the number of Shares as to which this Warrant is exercisable shall be proportionately decreased.

**2.4 Conversion of Preferred Stock.** If the Class is a class and series of the Company's convertible preferred stock, in the event that all outstanding shares of the Class are converted, automatically or by action of the holders thereof, into common stock pursuant to the provisions of the Company's Certificate of Incorporation, including, without limitation, in connection with the Company's initial, underwritten public offering and sale of its common stock pursuant to an effective registration statement under the Act (the "**IPO**"), then from and after the date on which all outstanding shares of the Class have been so converted, this Warrant shall be exercisable for such number of shares of common stock into which the Shares would have been converted had the Shares been outstanding on the date of such conversion, and the Exercise Price shall equal the Exercise Price in effect as of immediately prior to such conversion divided by the number of shares of common stock into which one Share would have been converted, all subject to further adjustment thereafter from time to time in accordance with the provisions of this Warrant.

**2.5 Adjustments for Diluting Issuances.** In the event of the issuance (a "**Diluting Issuance**") by Company, after the Issue Date of the Warrant, of any Additional Shares of Common Stock (as defined in the Company's Certificate of Incorporation) at a price per share less than the then Exercise Price, then the number of shares of common stock issuable upon conversion of the Shares, and the conversion price, shall be adjusted in accordance with those provisions (the "**Provisions**") of Company's Certificate of Incorporation which apply to Diluting Issuances with the same effect as though the shares were outstanding at the time of the diluting issuance. Company agrees that the

------

Exhibit 4.2

Provisions, as in effect on the Issue Date, shall be deemed to remain in full force and effect during the term of the Warrant notwithstanding any subsequent amendment, waiver or termination thereof by Company's shareholders. Under no circumstances shall the aggregate Exercise Price payable by Holder upon exercise of the Warrant increase as a result of any adjustment arising from a Diluting Issuance.

**2.6 Adjustment for Pay-to-Play Transactions.** In the event that the Company's Certificate of Incorporation provides, or is amended to so provide, for the amendment or modification of the rights, preferences or privileges of the Shares, or the reclassification, conversion or exchange of the outstanding Shares in the event that a holder of shares thereof fails to participate in an equity financing transaction (a "**Pay-to-Play Provision**"), and in the event that such Pay-to-Play Provision becomes operative in a transaction occurring after the date hereof, this Warrant shall automatically and without any action required become exercisable for that number and type of shares of equity securities as would have been issued or exchanged, or would have remained outstanding, in respect of the Shares issuable hereunder had this Warrant been exercised in full prior to such event, and had the Holder participated in the equity financing to the maximum extent permitted.

**2.7 No Impairment.** The Company shall not, by amendment of its Certificate of Incorporation or through a reorganization, transfer of assets, consolidation, merger, dissolution, issue, or sale of securities or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms to be observed or performed under this Warrant by Company, but shall at all times in good faith assist in carrying out of all the provisions of this Article 2 and in taking all such action as may be necessary or appropriate to protect Holder's rights under this Article against impairment. If the Company takes any action affecting the Shares or the Class as described above that adversely affects Holder's rights under this Warrant, the Exercise Price shall be adjusted downward and the number of Shares issuable upon exercise of this Warrant shall be adjusted upward in such a manner that such action is offset and the aggregate Exercise Price of this Warrant is unchanged. Notwithstanding the foregoing, the Company shall not be deemed to have impaired Holder's rights hereunder if: (a) it amends its Certificate of Incorporation, and the holders of the Company's preferred stock waive rights thereunder, in a manner that does not affect the Shares differently from the effect that such amendments or waivers have generally on the rights, preferences or restrictions of other shares of the same series of stock, or (b) the Shares are not differently affected than other shares of the same series of stock in connection with any reorganization, transfer of assets, consolidation, merger, dissolution, issue or sale of securities or any other voluntary action.

**2.8 Fractional Shares.** No fractional Shares shall be issuable upon exercise or conversion of the Warrant and the number of Shares to be issued shall be rounded down to the nearest whole Share. If a fractional share interest arises upon any exercise or conversion of the Warrant, the Company shall eliminate such fractional share interest by paying Holder an amount computed by multiplying the fractional interest by the fair market value of a full Share.

**2.9 Certificate as to Adjustments.** Upon each adjustment of the Exercise Price, Class and/or number of Shares, the Company at its expense shall promptly compute such adjustment, and furnish Holder with a certificate of its Chief Financial Officer setting forth the Exercise Price, Class and number of Shares in effect upon the date thereof and the series of adjustments leading to such Exercise Price, Class and number of Shares, and the facts upon which such adjustment is based.

**ARTICLE 3. REPRESENTATIONS, WARRANTIES AND COVENANTS OF COMPANY.**

**3.1 Representations and Warranties.** The Company hereby represents and warrants to, and agrees with, the Holder as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)** The initial Exercise Price referenced on the first page of this Warrant is not greater than the price per share for which shares of the Class were last sold and issued by the Company prior to the Issue Date hereof in an arms-length transaction in which at least $500,000 of such shares were sold.

------

Exhibit 4.2

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** As of the date hereof, the Company has sufficient authorized shares of capital stock reserved for the issuance of all Shares which may be issued upon the exercise of this Warrant and upon the conversion of all such Shares.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c)** The Company's capitalization table attached to this Warrant as Appendix 2 is true and complete as of the Issue Date.

**3.2 Valid Issuance.** The Company shall take all steps necessary to insure that all Shares which may be issued upon the exercise of this Warrant, and all securities which may be issued on conversion of such Shares, shall, upon issuance, be duly authorized, validly issued, fully paid and non-assessable, and free of any liens and encumbrances except for restrictions on transfer provided for herein or under applicable federal and state securities laws.

**3.3 Notice of Certain Events.** If the Company proposes at any time (a) to declare any dividend or distribution upon the outstanding shares of the Class, whether in cash, property, stock, or other securities and whether or not a regular cash dividend; (b) to offer for subscription pro rata to all holders of the outstanding shares of the Class any additional shares of stock of any class or series or other rights; (c) to effect any reclassification or recapitalization of the outstanding shares of the Class; (d) to merge or consolidate with or into any other corporation, or sell, lease, license, or convey all or substantially all of its assets, or to liquidate, dissolve or wind up; or (e) offer holders of registration rights the opportunity to participate in an underwritten public offering of the Company's securities for cash, then, in connection with each such event, the Company shall give Holder (1) in the case of the matters referred to in (a) and (b) above at least 20 days prior written notice of the date on which a record will be taken for such dividend, distribution, or subscription rights (and specifying the date on which the holders of common stock will be entitled thereto) or for determining rights to vote, if any, in respect of the matters referred to in (c) and (d) above; (2) in the case of the matters referred to in (c) and (d) above at least 20 days prior written notice of the date when the same will take place (and specifying the date on which the holders of common stock will be entitled to exchange their common stock for securities or other property deliverable upon the occurrence of such event); and (3) in the case of the matter referred to in (e) above, the same notice as is given to the holders of such registration rights.

**3.4 (a) Information.** So long as Holder holds this Warrant and/or any of the Shares, the Company shall deliver to Holder (a) promptly, copies of all notices or other written communications to which Holder would be entitled if it held Shares as to which this Warrant was then exercisable, and (b) such other financial statements required under and in accordance with any loan documents between Holder and the Company, or if there are no such requirements or if the subject loan(s) are no longer are outstanding, then within 45 days after the end of each of the first three quarters of each fiscal year, the Company's quarterly, unaudited financial statements and within 90 days after the end of each fiscal year, the Company's annual, audited financial statements. The Company shall also supply documentation to Holder reasonably necessary for Holder to evaluate whether to exercise (in cash or on a net issuance basis) this Warrant, including without limitation, (i) any merger/purchase/asset sale agreement and related documents and estimated payout allocations to each of the respective equityholders, warrant and option holders in connection with an Acquisition, (ii) the most recent capitalization tables, 409A valuations (if any), and board/member determination of share value (including any waterfall or per share allocations provided to the equityholders), and (iii) most recent certificate of incorporation/organization.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b) Exempt Transaction.** The issuance of this Warrant and of the Shares on exercise hereof will each constitute a transaction exempt from (i) the registration requirements of Section 5 of the Act, in reliance upon Section 4(a)(2) thereof and/or Regulation D thereunder, and (ii) the qualification requirements of applicable state securities laws.

------

Exhibit 4.2

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c) Compliance with Rule 144.** If Holder proposes to sell the Shares issuable upon the exercise of this Warrant in compliance with Rule 144 promulgated by the SEC, then, upon Holder's written request to the Company, the Company shall furnish to Holder, within ten days after receipt of such request, a written statement confirming the Company's compliance with the filing requirements of the SEC as set forth in such rule (as may be amended from time to time).

**3.5 Registration Rights.** The shares of common stock issuable on conversion of the Shares shall have the same "piggyback" registration rights as are set forth in the Company's Second Amended and Restated Investors' Rights Agreement dated November 13, 2020, as amended and in effect from time to time (the "**Investor Rights Agreement**"). The Company has provided Holder with a true and correct copy of the Investor Rights Agreement, which is in full force and effect on the date hereof. The Company agrees that no amendments will be made to the Investor Rights Agreement, which would have an adverse and disproportionate impact on Holder's registration rights thereunder.

**ARTICLE 4. REPRESENTATIONS, WARRANTIES AND COVENANTS OF HOLDER.**

Holder represents and warrants to, and agrees with, the Company as follows:

**4.1 Purchase for Own Account.** This Warrant and the securities to be acquired upon exercise of this Warrant by Holder are being acquired for investment for Holder's account, not as a nominee or agent, and not with a view to the public resale or distribution within the meaning of the Act. Holder also represents that it has not been formed for the specific purpose of acquiring this Warrant or the Shares.

**4.2 Disclosure of Information.** Holder is aware of the Company's business affairs and financial condition and has received or has had full access to all the information it considers necessary or appropriate to make an informed investment decision with respect to the acquisition of this Warrant and its underlying securities. Holder further has had an opportunity to ask questions and receive answers from the Company regarding the terms and conditions of the offering of this Warrant and its underlying securities and to obtain additional information (to the extent the Company possessed such information or could acquire it without unreasonable effort or expense) necessary to verify any information furnished to Holder or to which Holder has access.

**4.3 Investment Experience.** Holder understands that the purchase of this Warrant and its underlying securities involves substantial risk. Holder has experience as an investor in securities of companies in the development stage and acknowledges that Holder can bear the economic risk of such Holder's investment in this Warrant and its underlying securities and has such knowledge and experience in financial or business matters that Holder is capable of evaluating the merits and risks of its investment in this Warrant and its underlying securities and/or has a preexisting personal or business relationship with the Company and certain of its officers, directors or controlling persons of a nature and duration that enables Holder to be aware of the character, business acumen and financial circumstances of such persons.

**4.4 Accredited Investor Status.** Holder is an "accredited investor" within the meaning of Regulation D promulgated under the Act.

**4.5 The Act.** Holder understands that this Warrant and the Shares issuable upon exercise hereof have not been registered under the Act in reliance upon a specific exemption therefrom, which exemption depends upon, among other things, the bona fide nature of the Holder's investment intent as expressed herein. Holder understands that this Warrant and the Shares issued upon any exercise hereof must be held indefinitely unless subsequently registered under the Act and qualified under applicable state securities laws, or unless exemption from such registration and qualification are otherwise available. Holder is aware of the provisions of Rule 144 promulgated under the Act.

------

Exhibit 4.2

**4.6 Market Stand-off Agreement.** Holder agrees that the Shares shall be subject to the Market Standoff provisions in Section 2.11 of the Investor Rights Agreement.

**4.7 No Voting Rights.** Holder, as a Holder of this Warrant, will not have any voting rights until the exercise of this Warrant.

**4.8 Restrictions on Resales.** Holder acknowledges that this Warrant and the Shares issued upon any exercise hereof must be held indefinitely unless subsequently registered under the Securities Act or an exemption from such registration is available. Holder is aware of the provisions of Rule 144 promulgated under the Securities Act, which permit resale of shares purchased in a private placement subject to the satisfaction of certain conditions, which may include, among other things, the availability of certain current public information about the Company; the resale occurring not less than a specified period after a party has purchased and paid for the security to be sold; the number of shares being sold during any three-month period not exceeding specified limitations; the sale being effected through a "broker's transaction," a transaction directly with a "market maker" or a "riskless principal transaction" (as those terms are defined in the Securities Act or the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder); and the filing of a Form 144 notice, if applicable. Holder acknowledges and understands that the Company may not be satisfying the current public information requirement of Rule 144 at the time Holder wishes to sell this Warrant and the Shares issued upon any exercise hereof and that, in such event, Holder may be precluded from selling this Warrant and the Shares issued upon any exercise hereof under Rule 144 even if the other applicable requirements of Rule 144 have been satisfied. Holder acknowledges that, in the event the applicable requirements of Rule 144 are not met, registration under the Securities Act or an exemption from registration will be required for any disposition of this Warrant and the Shares issued upon any exercise hereof. Holder understands that, although Rule 144 is not exclusive, the Securities and Exchange Commission has expressed its opinion that persons proposing to sell restricted securities received in a private offering other than in a registered offering or pursuant to Rule 144 will have a substantial burden of proof in establishing that an exemption from registration is available for such offers or sales and that such persons and the brokers who participate in the transactions do so at their own risk.

**4.9 No Public Market.** Holder understands and acknowledges that no public market now exists for any of the securities issued by the Company and that the Company has made no assurances that a public market will ever exist for the Company's securities.

**4.10 Brokers and Finders.** Holder has not engaged any brokers, finders or agents in connection with this Warrant and the Shares issued upon any exercise hereof, and the Company has not incurred nor will incur, directly or indirectly, as a result of any action taken by Holder, any liability for brokerage or finders' fees or agents' commissions or any similar charges in connection with this Warrant and the Shares issued upon any exercise hereof.

**4.11 Advisors.** Holder has had the opportunity to review this Warrant and the transactions contemplated by this Warrant with its own legal counsel. Holder is not relying on any statements or representations of the Company or its agents for legal advice with respect to this investment or the transactions contemplated by this Warrant. Holder has reviewed with its own tax advisors the U.S. federal, state and local and non-U.S. tax consequences of this investment and the transactions contemplated by this Warrant. With respect to such matters, Holder relies solely on any such advisors and not on any statements or representations of the Company or any of its agents, written or oral. Holder understands that it (and not the Company) shall be responsible for its own tax liability that may arise as a result of this investment and the transactions contemplated by this Warrant.

**ARTICLE 5. MISCELLANEOUS.**

------

Exhibit 4.2

**5.1 Legends.** This Warrant and the Shares shall be imprinted with a legend in substantially the following form:

**THIS SECURITY HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, AND MAY NOT BE SOLD, PLEDGED OR OTHERWISE TRANSFERRED WITHOUT AN EFFECTIVE REGISTRATION THEREOF UNDER SUCH ACT OR PURSUANT TO RULE 144 OR AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO COMPANY AND ITS COUNSEL THAT SUCH REGISTRATION IS NOT REQUIRED.**

**5.2 Compliance with Securities Laws on Transfer.** This Warrant and the Shares issuable upon exercise of this Warrant may not be transferred or assigned in whole or in part without compliance with applicable federal and state securities laws by the transferor and the transferee (including, without limitation, the delivery of investment representation letters and legal opinions reasonably satisfactory to the Company, as reasonably requested by the Company). Company shall not require Holder to provide an opinion of counsel if (i) the transfer is to Holder's parent company, Western Alliance Bancorporation, or any other affiliate of Holder provided that such affiliate is an "accredited investor" within the meaning of Regulation D promulgated under the Act, or (ii) there is no material question as to the availability of current information as referenced in Rule 144(c), Holder represents that it has complied with Rule 144(d) and (e) in reasonable detail, the selling broker represents that it has complied with Rule 144(f), and the Company is provided with a copy of Holder's notice of proposed sale.

**5.3 Transfer Procedure.** After receipt by Holder of the executed Warrant, Holder may transfer all of this Warrant to Holder's parent company, Western Alliance Bancorporation, or an affiliate thereof or successor thereto (the "**Subsequent Holder**"), by execution of an Assignment substantially in the form of Appendix 3. Subject to the provisions of Article 5.2 and upon providing Company with written notice (except that such notice shall not be required of Holder or a Subsequent Holder in connection with a transaction described in clause (ii) of this Section 5.3), the Subsequent Holder may transfer all or part of this Warrant or the Shares issuable upon exercise of this Warrant (or the Shares issuable directly or indirectly, upon conversion of the Shares, if any) to any transferee, provided, however, in connection with any such transfer, the Subsequent Holder will give the Company notice of the portion of the Warrant being transferred with the name, address and taxpayer identification number of the transferee and Holder will surrender this Warrant to the Company for reissuance to the transferee(s) (and Holder if applicable). Notwithstanding any contrary provision herein, at all times prior to the IPO, Holder may not, without the Company's prior written consent, transfer this Warrant or any portion hereof, or any Shares issued upon any exercise hereof, or any shares or other securities issued upon any conversion of any Shares issued upon any exercise hereof, to any person or entity who directly competes with the Company, except in connection with (i) an Acquisition of the Company by such a direct competitor, or (ii) any sale, transfer, negotiation, or grant of participation in all or any part of, or any interest in, Bank's (as defined in the Loan Agreement) obligations, rights and benefits under the Loan Agreement.

**5.4 Notices.** All notices and other communications from the Company to Holder, or vice versa, shall be in writing and shall be deemed delivered and effective when given personally or mailed by first-class registered or certified mail, postage prepaid, or by overnight courier, at such address as may have been furnished to the Company or Holder, as the case may be, in writing by the Company or such Holder from time to time.

**5.5 Attorneys' Fees.** In the event of any dispute between the parties concerning the terms and provisions of this Warrant, the party prevailing in such dispute shall be entitled to collect from the other party all costs incurred in such dispute, including reasonable attorneys' fees.

**5.6 Governing Law.** This Warrant shall be governed by and construed in accordance with the laws of the State of Delaware, without giving effect to its principles regarding conflicts of law.

------

Exhibit 4.2

**5.7 Counterparts.** This Warrant may be executed by one or more of the parties hereto in any number of separate counterparts, all of which together shall constitute one and the same instrument.

**5.8 Taxes.** In no event shall the Company be required to pay any tax which may be payable in respect of any transfer involved in the issue and delivery of any certificate in a name other than that of Holder, and the Company shall not be required to issue or deliver any such certificate unless and until the person or persons requesting the issue thereof shall have paid to the Company the amount of such tax or shall have established to the satisfaction of the Company that such tax has been paid or is not payable.

[BALANCE OF PAGE INTENTIONALLY LEFT BLANK]

------

Exhibit 4.2

**IN WITNESS WHEREOF**, the undersigned has executed this Warrant to Purchase Stock as of the day and year first above written.

**COMPANY:**

**FAETH THERAPEUTICS, INC.**

By: <u>/s/ Anand Parikh</u>____________________________

Name: Anand Parikh

Title: CEO

*[Signature Page to Warrant to Purchase Stock]*

------

## Exhibit 10.6

Exhibit 10-6

**2019 Stock Incentive Plan**

**of**

**Faeth Therapeutics, Inc.**

------

table of contents

Page

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| | |
|:---|:---|
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1. Purpose | 3 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2. Eligibility | 3 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3. Administration and Delegation | 3 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Administration by the Board | 3 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Appointment of Committees | 3 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4. Stock Available for Awards | 3 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Number of Shares | 4 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Substitute Awards | 4 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5. Stock Options | 4 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) General | 4 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Incentive Stock Options | 4 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) Exercise Price | 4 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Duration of Options | 5 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) Exercise of Options | 5 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) Payment Upon Exercise | 5 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6. Stock Appreciation Rights | 6 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) General | 6 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Measurement Price | 6 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) Duration of SARs | 6 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Exercise of SARs | 6 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7. Restricted Stock; Restricted Stock Units | 6 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) General | 6 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Terms and Conditions for All Restricted Stock Awards | 7 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) Additional Provisions Relating to Restricted Stock. | 7 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Additional Provisions Relating to Restricted Stock Units. | 7 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8. Other Stock-Based Awards | 7 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) General | 7 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Terms and Conditions | 8 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9. Adjustments for Changes in Common Stock and Certain Other Events | 8 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Changes in Capitalization | 8 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Reorganization Events. | 8 |

---

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---

| | |
|:---|:---|
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10. General Provisions Applicable to Awards. | 10 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Transferability of Awards | 10 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Documentation | 10 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) Board Discretion | 10 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Termination of Status | 10 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) Withholding | 10 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) Amendment of Award. | 11 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g) Conditions on Delivery of Stock | 11 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h) Acceleration | 11 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11. Miscellaneous. | 11 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) No Right To Employment or Other Status | 11 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) No Rights As Stockholder | 12 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) Effective Date and Term of Plan | 12 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Amendment of Plan | 12 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) Authorization of Sub-Plans (including Grants to non-U.S | 12 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) Compliance with Section 409A of the Code | 12 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g) Limitations on Liability | 12 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h) Governing Law | 13 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1. Additional Limitations on Options. | 14 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Maximum Duration of Options | 14 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Minimum Exercise Period Following Termination | 14 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2. Additional Limitations for Other Stock-Based Awards | 14 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3. Additional Limitations on Timing of Awards | 14 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4. Additional Restriction Regarding Recapitalizations, Stock Splits, Etc | 14 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5. Additional Limitations on Transferability of Awards | 14 |

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**2019 Stock Incentive Plan**

**of**

**Faeth Therapeutics, Inc.**

1. <u>Purpose</u>

The purpose of this 2019 Stock Incentive Plan (the "**Plan**") of Faeth Therapeutics, Inc., a Delaware corporation (the "**Company**"), is to advance the interests of the Company's stockholders by enhancing the Company's ability to attract, retain and motivate persons who are expected to make important contributions to the Company and by providing such persons with equity ownership opportunities and performance-based incentives that are intended to better align the interests of such persons with those of the Company's stockholders. Except where the context otherwise requires, the term "**Company**" shall include any of the Company's present and future parent or subsidiary corporations as defined in Sections 424(e) or (f) of the Internal Revenue Code of 1986, as amended, and any regulations thereunder (the "**Code**") and any other business venture (including, without limitation, joint venture or limited liability company) in which the Company has a controlling interest, as determined by the Board of Directors of the Company (the "**Board**"); *provided*, *however*, that such other business ventures shall be limited to entities that, where required by Section 409A of the Code, are eligible issuers of service recipient stock (as defined in Treas. Reg. Section 1.409A-1(b)(5)(iii)(E), or applicable successor regulation).

2. <u>Eligibility</u>

All of the Company's employees, officers and directors, as well as consultants and advisors to the Company (as such terms consultants and advisors are defined and interpreted for purposes of Rule 701 under the Securities Act of 1933, as amended (the "**Securities Act**") (or any successor rule)) are eligible to be granted Awards under the Plan. Each person who is granted an Award under the Plan is deemed a "**Participant.**" "**Award**" means Options (as defined in Section 5), SARs (as defined in Section 6), Restricted Stock (as defined in Section 7), Restricted Stock Units (as defined in Section 7) and Other Stock-Based Awards (as defined in Section 8).

3. <u>Administration and Delegation</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) <u>Administration by the Board</u>. The Plan will be administered by the Board. The Board shall have authority to grant Awards and to adopt, amend and repeal such administrative rules, guidelines and practices relating to the Plan as it shall deem advisable. The Board may construe and interpret the terms of the Plan and any Award agreements entered into under the Plan. The Board may correct any defect, supply any omission or reconcile any inconsistency in the Plan or any Award in the manner and to the extent it shall deem expedient to carry the Plan into effect and it shall be the sole and final judge of such expediency. All actions and decisions by the Board with respect to the Plan and any Awards shall be made in the Board's discretion and shall be final and binding on all Participants and any other persons having or claiming any interest in the Plan or in any Award.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) <u>Appointment of Committees</u>. To the extent permitted by applicable law, the Board may delegate any or all of its powers under the Plan to one or more committees or subcommittees of the Board (each, a "**Committee**"). All references in the Plan to the "**Board**" shall mean the Board or a Committee to the extent that the Board's powers or authority under the Plan have been delegated to such Committee.

4. <u>Stock Available for Awards</u>

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Number of Shares. Subject to adjustment under Section 9, Awards may be made under the Plan for up to 3,636,410 shares of common stock, $0.0001 par value per share, of the Company (the "**Common Stock**"), any or all of which Awards may be in the form of Incentive Stock Options (as defined in Section 5(b)). If any Award expires or is terminated, surrendered or canceled without having been fully exercised, is forfeited in whole or in part (including as the result of shares of Common Stock subject to such Award being repurchased by the Company at the original issuance price pursuant to a contractual repurchase right), or results in any Common Stock not being issued, the unused Common Stock subject to such Award shall again be available for the grant of Awards under the Plan. Further, shares of Common Stock tendered to the Company by a Participant to exercise an Award or to satisfy tax withholding obligations arising with respect to an Award shall be added to the number of shares of Common Stock available for the grant of Awards under the Plan. However, in the case of Incentive Stock Options, the two immediately preceding sentences shall be subject to any limitations under the Code. Shares issued under the Plan may consist in whole or in part of authorized but unissued shares or treasury shares.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) <u>Substitute Awards</u>. In connection with a merger or consolidation of an entity with the Company or the acquisition by the Company of property or stock of an entity, the Board may grant Awards in substitution for any options or other stock or stock-based awards granted by such entity or an affiliate thereof. Substitute Awards may be granted on such terms as the Board deems appropriate in the circumstances, notwithstanding any limitations on Awards contained in the Plan. Substitute Awards shall not count against the overall share limit set forth in Section 4(a), except as may be required by reason of Section 422 and related provisions of the Code.

5. <u>Stock Options</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) <u>General</u>. The Board may grant options to purchase Common Stock (each, an "**Option**") and determine the number of shares of Common Stock to be subject to each Option, the exercise price of each Option and the conditions and limitations applicable to the exercise of each Option, including conditions relating to applicable federal or state securities laws, as it considers necessary or advisable.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) <u>Incentive Stock Options</u>. An Option that the Board intends to be an "**incentive stock option**" as defined in Section 422 of the Code (an "**Incentive Stock Option**") shall only be granted to employees of Faeth Therapeutics, Inc., any of Faeth Therapeutics, Inc.'s present and future parent or subsidiary corporations as defined in Sections 424(e) or (f) of the Code, and any other entities the employees of which are eligible to receive Incentive Stock Options under the Code, and shall be subject to and shall be construed consistently with the requirements of Section 422 of the Code. An Option that is not intended to be an Incentive Stock Option shall be designated non-statutory stock option (a "**Nonstatutory Stock Option).**" The Company shall have no liability to a Participant, or any other person, if an Option (or any part thereof) that is intended to be an Incentive Stock Option is not an Incentive Stock Option or if the Company converts an Incentive Stock Option to a Nonstatutory Stock Option.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) <u>Exercise Price</u>. The Board shall establish the exercise price of each Option and specify the exercise price in the applicable Option agreement. The exercise price shall be not less than 100% of the Grant Date Fair Market Value (as defined below) of the Common Stock on the date the Option is granted; provided that if the Board approves the grant of an Option with an exercise price to be determined on a future date, the exercise price shall not be less than 100% of the Grant Date Fair Market Value on such future date. The "**Grant Date Fair Market Value**" of a share of Common Stock for purposes of the Plan will be determined as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) if the Common Stock is not publicly traded, the Board will determine the Fair Market Value for purposes of the Plan using any measure of value it determines to be appropriate (including,

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as it considers appropriate, relying on appraisals) in a manner consistent with the valuation principles under Code Section 409A, except as the Board may expressly determine otherwise;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) if the Common Stock is listed on a national securities exchange, the closing sale price (for the primary trading session) on the date of grant; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(3) if the Common Stock is not listed on any such exchange, the average of the closing bid and asked prices as reported by an authorized OTCBB market data vendor as listed on the OTCBB website (otcbb.com) on the date of grant.

For any date that is not a trading day, the Grant Date Fair Market Value of a share of Common Stock for such date will be determined by using the closing sale price or average of the bid and asked prices, as appropriate, for the immediately preceding trading day and with the timing in the formulas above adjusted accordingly. The Board can substitute a particular time of day or other measure of "**closing sale price**" or "**bid and asked prices**" if appropriate because of exchange or market procedures or can, in its discretion, use weighted averages either on a daily basis or such longer period as complies with Code Section 409A.

The Board has discretion to determine the Grant Date Fair Market Value for purposes of the Plan, and all Awards are conditioned on the applicable Participant's agreement that the Board's determination is conclusive and binding even though others might make a different determination.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) <u>Duration of Options</u>. Each Option shall be exercisable at such times and subject to such terms and conditions as the Board may specify in the applicable option agreement; provided, however, that no Option will be granted with a term in excess of 10 years.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) <u>Exercise of Options</u>. Options may be exercised by delivery to the Company of a notice of exercise in a form of notice (which may be electronic) approved by the Company, together with payment in full (in the manner specified in Section 5(f)) of the exercise price for the number of shares for which the Option is exercised. Shares of Common Stock subject to the Option will be delivered by the Company as soon as practicable following exercise.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) <u>Payment Upon Exercise</u>. Common Stock purchased upon the exercise of an Option granted under the Plan shall be paid for as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) in cash or by check, payable to the order of the Company;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) when the Common Stock is registered under the Securities Exchange Act of 1934, as amended (the "**Exchange Act**"), except as may otherwise be provided in the applicable Option agreement or approved by the Board, in its discretion, by (i) delivery of an irrevocable and unconditional undertaking by a creditworthy broker to deliver promptly to the Company sufficient funds to pay the exercise price and any required tax withholding or (ii) delivery by the Participant to the Company of a copy of irrevocable and unconditional instructions to a creditworthy broker to deliver promptly to the Company cash or a check sufficient to pay the exercise price and any required tax withholding;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(3) when the Common Stock is registered under the Exchange Act and to the extent provided for in the applicable Option agreement or approved by the Board, in its discretion, by delivery (either by actual delivery or attestation) of shares of Common Stock owned by the Participant valued at their fair market value (valued in the manner determined by (or in a manner approved by) the Board), *provided* (i) such method of payment is then permitted under applicable law, (ii) such Common Stock, if acquired directly from the Company, was owned by the Participant for such minimum period of time, if

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any, as may be established by the Board in its discretion and such Common Stock is not subject to any repurchase, forfeiture, unfulfilled vesting or other similar requirements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(4) to the extent provided for in the applicable Nonstatutory Stock Option agreement or approved by the Board in its discretion, by delivery of a notice of "**net exercise**" to the Company, as a result of which the Participant would receive (i) the number of shares underlying the portion of the Option being exercised, less (ii) such number of shares as is equal to (A) the aggregate exercise price for the portion of the Option being exercised divided by (B) the fair market value of the Common Stock (valued in the manner determined by (or in a manner approved by) the Board) on the date of exercise;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(5) to the extent permitted by applicable law and provided for in the applicable Option agreement or approved by the Board, in its discretion, by (i) delivery of a promissory note of the Participant to the Company on terms determined by the Board, or (ii) payment of such other lawful consideration as the Board may determine; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(6) by any combination of the above permitted forms of payment.

6. <u>Stock Appreciation Rights</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) <u>General</u>. The Board may grant Awards consisting of stock appreciation rights ("**SARs**") entitling the Participant, upon exercise, to receive an amount of Common Stock or cash or a combination thereof (such form to be determined by the Board) determined by reference to appreciation, from and after the date of grant, in the fair market value of a share of Common Stock (valued in the manner determined by (or in a manner approved by) the Board) over the measurement price established pursuant to Section 6(b). The date as of which such appreciation is determined shall be the exercise date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) <u>Measurement Price</u>. The Board shall establish the measurement price of each SAR and specify it in the applicable SAR agreement. The measurement price shall not be less than 100% of the Grant Date Fair Market Value of a share of Common Stock on the date the SAR is granted; *provided*, that if the Board approves the grant of an SAR effective as of a future date, the measurement price shall not be less than 100% of the Grant Date Fair Market Value on such future date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) <u>Duration of SARs</u>. Each SAR shall be exercisable at such times and subject to such terms and conditions as the Board may specify in the applicable SAR agreement; provided, however, that no SAR will be granted with a term in excess of 10 years.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) <u>Exercise of SARs</u>. SARs may be exercised by delivery to the Company of a notice of exercise in a form (which may be electronic) approved by the Company, together with any other documents required by the Board.

7. <u>Restricted Stock; Restricted Stock Units</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) <u>General</u>. The Board may grant Awards entitling Participants to acquire shares of Common Stock ("**Restricted Stock**"), subject to the right of the Company to repurchase all or part of such shares at their issue price or other stated or formula price (or to require forfeiture of such shares if issued at no cost) from the Participant in the event that conditions specified by the Board in the applicable Award are not satisfied prior to the end of the applicable restriction period or periods established by the Board for such Award. The Board may also grant Awards entitling the Participant to receive shares of Common Stock or cash to be delivered at the time such Award vests ("**Restricted Stock Units**") (Restricted Stock and Restricted Stock Units are each referred to herein as a "**Restricted Stock Award**").

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) <u>Terms and Conditions for All Restricted Stock Awards</u>. The Board shall determine the terms and conditions of a Restricted Stock Award, including the conditions for vesting and repurchase (or forfeiture) and the issue price, if any.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) <u>Additional Provisions Relating to Restricted Stock</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) <u>Dividends</u>. Unless otherwise provided in the applicable Award agreement, any dividends (whether paid in cash, stock or property) declared and paid by the Company with respect to shares of Restricted Stock ("**Accrued Dividends**") shall be paid to the Participant only if and when such shares become free from the restrictions on transferability and forfeitability that apply to such shares. Each payment of Accrued Dividends will be made no later than the end of the calendar year in which the dividends are paid to stockholders of that class of stock or, if later, the 15th day of the third month following the lapsing of the restrictions on transferability and the forfeitability provisions applicable to the underlying shares of Restricted Stock.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) <u>Stock Certificates</u>. The Company may require that any stock certificates issued in respect of shares of Restricted Stock, as well as dividends or distributions paid on such Restricted Stock, shall be deposited in escrow by the Participant, together with a stock power endorsed in blank, with the Company (or its designee). At the expiration of the applicable restriction periods, the Company (or such designee) shall deliver the certificates no longer subject to such restrictions to the Participant or if the Participant has died, to Participant's Designated Beneficiary. "**Designated Beneficiary**" means (i) the beneficiary designated, in a manner determined by the Board, by a Participant to receive amounts due or exercise rights of the Participant in the event of the Participant's death or (ii) in the absence of an effective designation by a Participant, "**Designated Beneficiary**" means the Participant's estate.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) <u>Additional Provisions Relating to Restricted Stock Units</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) <u>Settlement</u>. Upon the vesting of and/or lapsing of any other restrictions (i.e., settlement) with respect to each Restricted Stock Unit, the Participant shall be entitled to receive from the Company the number of shares of Common Stock specified in the Award agreement or (if so provided in the applicable Award agreement or otherwise determined by the Board) an amount of cash equal to the fair market value (valued in the manner determined by (or in a manner approved by) the Board) of such number of shares of Common Stock or a combination thereof. The Board may, in its discretion, provide that settlement of Restricted Stock Units shall be deferred, on a mandatory basis or at the election of the Participant in a manner that complies with Section 409A of the Code.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) <u>Voting Rights</u>. A Participant shall have no voting rights with respect to any Restricted Stock Units.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(3) <u>Dividend Equivalents</u>. The Award agreement for Restricted Stock Units may provide Participants with the right to receive an amount equal to any dividends or other distributions declared and paid on an equal number of outstanding shares of Common Stock ("**Dividend Equivalents**"). Dividend Equivalents may be paid currently or credited to an account for the Participants, may be settled in cash and/or shares of Common Stock and may be subject to the same restrictions on transfer and forfeitability as the Restricted Stock Units with respect to which paid, in each case to the extent provided in the applicable Award agreement.

8. <u>Other Stock-Based Awards</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) <u>General</u>. The Board may grant other Awards of shares of Common Stock, and other Awards that are valued in whole or in part by reference to, or are otherwise based on, shares of Common

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Stock or other property ("**Other Stock-Based Awards**"). Such Other Stock-Based Awards shall also be available as a form of payment in the settlement of other Awards granted under the Plan or as payment in lieu of compensation to which a Participant is otherwise entitled. Other Stock-Based Awards may be paid in shares of Common Stock or cash, as the Board shall determine.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) <u>Terms and Conditions</u>. Subject to the provisions of the Plan, the Board shall determine the terms and conditions of each Other Stock-Based Award, including any purchase price applicable thereto.

9. <u>Adjustments for Changes in Common Stock and Certain Other Events</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) <u>Changes in Capitalization</u>. In the event of any stock split, reverse stock split, stock dividend, recapitalization, combination of shares, reclassification of shares, spin-off or other similar change in capitalization or event, or any dividend or distribution to holders of Common Stock other than an ordinary cash dividend, (i) the number and class of securities available under the Plan, (ii) the number and class of securities and exercise price per share of each outstanding Option, (iii) the share and per-share provisions and the measurement price of each outstanding SAR, (iv) the number of shares subject to and the repurchase price per share subject to each outstanding Award of Restricted Stock and (v) the share and per-share-related provisions and the purchase price, if any, of each outstanding Award of Restricted Stock Unit and each outstanding Other Stock-Based Award, shall be equitably adjusted by the Company (or substituted Awards may be made, if applicable) in the manner determined by the Board. Without limiting the generality of the foregoing, in the event the Company effects a split of the Common Stock by means of a stock dividend and the exercise price of and the number of shares subject to an outstanding Option are adjusted as of the date of the distribution of the dividend (rather than as of the record date for such dividend), then an optionee who exercises an Option between the record date and the distribution date for such stock dividend shall be entitled to receive, on the distribution date, the stock dividend with respect to the shares of Common Stock acquired upon such Option exercise, notwithstanding the fact that such shares were not outstanding as of the close of business on the record date for such stock dividend.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) <u>Reorganization Events</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) <u>Definition</u>. A "**Reorganization Event**" shall mean: (a) any merger or consolidation of the Company with or into another entity as a result of which all of the Common Stock of the Company is converted into or exchanged for the right to receive cash, securities or other property or is cancelled, (b) any transfer or disposition of all of the Common Stock of the Company for cash, securities or other property pursuant to a share exchange or other transaction or (c) any liquidation or dissolution of the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) <u>Consequences of a Reorganization Event on Awards Other than Restricted Stock</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) In connection with a Reorganization Event, the Board may take any one or more of the following actions as to all or any (or any portion of) outstanding Awards other than Restricted Stock on such terms as the Board determines (except to the extent specifically provided otherwise in an applicable Award agreement or another agreement between the Company and the Participant): (i) provide that such Awards shall be assumed, or substantially equivalent Awards shall be substituted, by the acquiring or succeeding corporation (or an affiliate thereof), (ii) upon written notice to a Participant, provide that all of the Participant's unexercised and/or unvested Awards will terminate immediately prior to the consummation of such Reorganization Event unless exercised by the Participant (to the extent then exercisable) within a specified period following the date of such notice, (iii) provide that outstanding Awards shall become exercisable, realizable, or deliverable, or restrictions applicable to an Award shall lapse, in whole or in part prior to or upon such Reorganization Event, (iv) in the event of a Reorganization Event under the terms of which holders of Common Stock will receive upon consummation thereof a cash

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payment for each share surrendered in the Reorganization Event (the "**Acquisition Price**"), make or provide for a cash payment to Participants with respect to each Award held by a Participant equal to (A) the number of shares of Common Stock subject to the vested portion of the Award (after giving effect to any acceleration of vesting that occurs upon or immediately prior to such Reorganization Event) multiplied by (B) the excess, if any, of (I) the Acquisition Price over (II) the exercise, measurement or purchase price of such Award and any applicable tax withholdings, in exchange for the termination of such Award, (v) provide that, in connection with a liquidation or dissolution of the Company, Awards shall convert into the right to receive liquidation proceeds (if applicable, net of the exercise, measurement or purchase price thereof and any applicable tax withholdings) and (vi) any combination of the foregoing. In taking any of the actions permitted under this Section 9(b)(2), the Board shall not be obligated by the Plan to treat all Awards, all Awards held by a Participant, or all Awards of the same type, identically.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) Notwithstanding the terms of Section 9(b)(2)(i), in the case of outstanding Restricted Stock Units that are subject to Section 409A of the Code: (i) if the applicable Restricted Stock Unit agreement provides that the Restricted Stock Units shall be settled upon a "**change in control event**" within the meaning of Treasury Regulation Section 1.409A- 3(i)(5)(i), and the Reorganization Event constitutes such a "**change in control event**", then no assumption or substitution shall be permitted pursuant to Section 9(b)(2)(i) and the Restricted Stock Units shall instead be settled in accordance with the terms of the applicable Restricted Stock Unit agreement; and (ii) the Board may only undertake the actions set forth in clauses (iii), (iv) or (v) of Section 9(b)(2)(i) if the Reorganization Event constitutes a "**change in control event**" as defined under Treasury Regulation Section 1.409A-3(i)(5)(i) and such action is permitted or required by Section 409A of the Code; if the Reorganization Event is not a "**change in control event**" as so defined or such action is not permitted or required by Section 409A of the Code, and the acquiring or succeeding corporation does not assume or substitute the Restricted Stock Units pursuant to clause (i) of Section 9(b)(2)(i), then the unvested Restricted Stock Units shall terminate immediately prior to the consummation of the Reorganization Event without any payment in exchange therefor.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii) For purposes of Section 9(b)(2)(i), an Award (other than Restricted Stock) shall be considered assumed if, following consummation of the Reorganization Event, such Award confers the right to purchase or receive pursuant to the terms of such Award, for each share of Common Stock subject to the Award immediately prior to the consummation of the Reorganization Event, the consideration (whether cash, securities or other property) received as a result of the Reorganization Event by holders of Common Stock for each share of Common Stock held immediately prior to the consummation of the Reorganization Event (and if holders were offered a choice of consideration, the type of consideration chosen by the holders of a majority of the outstanding shares of Common Stock); provided, however, that if the consideration received as a result of the Reorganization Event is not solely common stock of the acquiring or succeeding corporation (or an affiliate thereof), the Company may, with the consent of the acquiring or succeeding corporation, provide for the consideration to be received upon the exercise or settlement of the Award to consist solely of such number of shares of common stock of the acquiring or succeeding corporation (or an affiliate thereof) that the Board determined to be equivalent in value (as of the date of such determination or another date specified by the Board) to the per share consideration received by holders of outstanding shares of Common Stock as a result of the Reorganization Event.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(3) <u>Consequences of a Reorganization Event on Restricted Stock</u>. Upon the occurrence of a Reorganization Event other than a liquidation or dissolution of the Company, the repurchase and other rights of the Company with respect to outstanding Restricted Stock shall inure to the benefit of the Company's successor and shall, unless the Board determines otherwise, apply to the cash, securities or other property which the Common Stock was converted into or exchanged for pursuant to such Reorganization Event in the same manner and to the same extent as they applied to such Restricted Stock; *provided*, *however*, that the Board may provide for termination or deemed satisfaction of such repurchase or other rights under the instrument evidencing any Restricted Stock or any other agreement between a

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Participant and the Company, either initially or by amendment, or provide for forfeiture of such Restricted Stock if issued at no cost. Upon the occurrence of a Reorganization Event involving the liquidation or dissolution of the Company, except to the extent specifically provided to the contrary in the instrument evidencing any Restricted Stock or any other agreement between a Participant and the Company, all restrictions and conditions on all Restricted Stock then outstanding shall automatically be deemed terminated or satisfied.

10. <u>General Provisions Applicable to Awards</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) <u>Transferability of Awards</u>. Awards (or any interest in an Award, including, prior to exercise, any interest in shares of Common Stock issuable upon exercise of an Option or SAR) shall not be sold, assigned, transferred (including by establishing any short position, put equivalent position (as defined in Rule 16a-1 issued under the Exchange Act) or call equivalent position (as defined in Rule 16a-1 issued under the Exchange Act)), pledged, hypothecated or otherwise encumbered by the person to whom they are granted, either voluntarily or by operation of law, and, during the life of the Participant, shall be exercisable only by the Participant; except that Awards, other than Awards subject to Section 409A of the Code, may be transferred to family members (as defined in Rule 701(c)(3) under the Securities Act) through gifts or (other than Incentive Stock Options) domestic relations orders or to an executor or guardian upon the death or disability of the Participant. The Company shall not be required to recognize any such permitted transfer until such time as such permitted transferee shall deliver to the Company a written instrument, as a condition to such transfer, in form and substance satisfactory to the Company confirming that such transferee shall be bound by all of the terms and conditions of the Award. References to a Participant, to the extent relevant in the context, shall include references to authorized transferees. For the avoidance of doubt, nothing contained in this Section 10(a) shall be deemed to restrict a transfer to the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) <u>Documentation</u>. Each Award shall be evidenced in such form (written, electronic or otherwise) as the Board shall determine. Each Award may contain terms and conditions in addition to those set forth in the Plan.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) <u>Board Discretion</u>. Except as otherwise provided by the Plan, each Award may be made alone or in addition or in relation to any other Award. The terms of each Award need not be identical, and the Board need not treat Participants uniformly.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) <u>Termination of Status</u>. The Board shall determine the effect on an Award of the disability, death, termination or other cessation of employment, authorized leave of absence or other change in the employment or other status of a Participant and the extent to which, and the period during which, the Participant, or the Participant's legal representative, conservator, guardian or Designated Beneficiary, may exercise rights under the Award.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) <u>Withholding</u>. The Participant must satisfy all applicable federal, state, and local or other income and employment tax withholding obligations before the Company will deliver stock certificates or otherwise recognize ownership of Common Stock under an Award. The Company may elect to satisfy the withholding obligations through additional withholding on salary or wages. If the Company elects not to or cannot withhold from other compensation, the Participant must pay the Company the full amount, if any, required for withholding or have a broker tender to the Company cash equal to the withholding obligations. Payment of withholding obligations is due before the Company will issue any shares on exercise, vesting or release from forfeiture of an Award or at the same time as payment of the exercise or purchase price unless the Company determines otherwise. If provided for in an Award or approved by the Board in its discretion, a Participant may satisfy such tax obligations in whole or in part by delivery (either by actual delivery or attestation) of shares of Common Stock, including shares retained from the Award creating the tax obligation, valued at their fair market value (valued in the manner determined by (or in a manner

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approved by) the Company); *provided*, *however*, except as otherwise provided by the Board, that the total tax withholding where stock is being used to satisfy such tax obligations cannot exceed the Company's minimum statutory withholding obligations (based on minimum statutory withholding rates for federal and state tax purposes, including payroll taxes, that are applicable to such supplemental taxable income), *except that*, to the extent that the Company is able to retain shares of Common Stock having a fair market value (valued in the manner determined by (or in a manner approved by) the Company) that exceeds the statutory minimum applicable withholding tax without financial accounting implications or the Company is withholding in a jurisdiction that does not have a statutory minimum withholding tax, the Company may retain such number of shares of Common Stock (up to the number of shares having a fair market value (valued in the manner determined by (or in a manner approved by) the Company) equal to the maximum individual statutory rate of tax) as the Company shall determine in its discretion to satisfy the tax liability associated with any Award. Shares used to satisfy tax withholding requirements cannot be subject to any repurchase, forfeiture, unfulfilled vesting or other similar requirements.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) <u>Amendment of Award</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) The Board may amend, modify or terminate any outstanding Award, including but not limited to, substituting therefor another Award of the same or a different type, changing the date of exercise or realization, and converting an Incentive Stock Option to a Nonstatutory Stock Option. The Participant's consent to such action shall be required unless (i) the Board determines that the action, taking into account any related action, does not materially and adversely affect the Participant's rights under the Plan or (ii) the change is permitted under Section 9.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) The Board may, without stockholder approval, amend any outstanding Award granted under the Plan to provide an exercise price per share that is lower than the then- current exercise price per share of such outstanding Award. The Board may also, without stockholder approval, cancel any outstanding award (whether or not granted under the Plan) and grant in substitution therefor new Awards under the Plan covering the same or a different number of shares of Common Stock and having an exercise price per share lower than the then-current exercise price per share of the cancelled award.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g) <u>Conditions on Delivery of Stock</u>. The Company will not be obligated to deliver any shares of Common Stock pursuant to the Plan or to remove restrictions from shares previously issued or delivered under the Plan until (i) all conditions of the Award have been met or removed to the satisfaction of the Company, (ii) in the opinion of the Company's counsel, all other legal matters in connection with the issuance and delivery of such shares have been satisfied, including any applicable securities laws and regulations and any applicable stock exchange or stock market rules and regulations, and (iii) the Participant has executed and delivered to the Company such representations or agreements as the Company may consider appropriate to satisfy the requirements of any applicable laws, rules or regulations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h) <u>Acceleration</u>. The Board may at any time provide that any Award shall become immediately exercisable in whole or in part, free of some or all restrictions or conditions, or otherwise realizable in whole or in part, as the case may be.

11. <u>Miscellaneous</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) <u>No Right To Employment or Other Status</u>. No person shall have any claim or right to be granted an Award by virtue of the adoption of the Plan, and the grant of an Award shall not be construed as giving a Participant the right to continued employment or any other relationship with the Company. The Company expressly reserves the right at any time to dismiss or otherwise terminate its relationship with a Participant free from any liability or claim under the Plan, except as expressly provided in the applicable Award.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) <u>No Rights As Stockholder</u>. Subject to the provisions of the applicable Award, no Participant or Designated Beneficiary shall have any rights as a stockholder with respect to any shares of Common Stock to be distributed with respect to an Award until becoming the record holder of such shares.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) <u>Effective Date and Term of Plan</u>. The Plan shall become effective on the date on which it is adopted by the Board. No Awards shall be granted under the Plan after the expiration of 10 years from the earlier of (i) the date on which the Plan was adopted by the Board or (ii) the date the Plan was approved by the Company's stockholders, but Awards previously granted may extend beyond that date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) <u>Amendment of Plan</u>. The Board may amend, suspend or terminate the Plan or any portion thereof at any time; provided that if at any time the approval of the Company's stockholders is required as to any modification or amendment under Section 422 of the Code or any successor provision with respect to Incentive Stock Options, the Board may not effect such modification or amendment without such approval. Unless otherwise specified in the amendment, any amendment to the Plan adopted in accordance with this Section 11(d) shall apply to, and be binding on the holders of, all Awards outstanding under the Plan at the time the amendment is adopted, provided the Board determines that such amendment, taking into account any related action, does not materially and adversely affect the rights of Participants under the Plan.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) <u>Authorization of Sub-Plans (including Grants to non-U.S. Employees)</u>. The Board may from time to time establish one or more sub-plans under the Plan for purposes of satisfying applicable securities, tax or other laws of various jurisdictions. The Board shall establish such sub-plans by adopting supplements to the Plan containing (i) such limitations on the Board's discretion under the Plan as the Board deems necessary or desirable or (ii) such additional terms and conditions not otherwise inconsistent with the Plan as the Board shall deem necessary or desirable. All supplements adopted by the Board shall be deemed to be part of the Plan, but each supplement shall apply only to Participants within the affected jurisdiction and the Company shall not be required to provide copies of any supplement to Participants in any jurisdiction which is not the subject of such supplement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) <u>Compliance with Section 409A of the Code</u>. If and to the extent (i) any portion of any payment, compensation or other benefit provided to a Participant pursuant to the Plan in connection with Participant's employment termination constitutes "**nonqualified deferred compensation**" within the meaning of Section 409A of the Code and (ii) the Participant is a specified employee as defined in Section 409A(a)(2)(B)(i) of the Code, in each case as determined by the Company in accordance with its procedures, by which determinations the Participant (through accepting the Award) agrees that the Participant is bound, such portion of the payment, compensation or other benefit shall not be paid before the day that is six months plus one day after the date of "**separation from service**" (as determined under Section 409A of the Code) (the "**New Payment Date**"), except as Section 409A of the Code may then permit. The aggregate of any payments that otherwise would have been paid to the Participant during the period between the date of separation from service and the New Payment Date shall be paid to the Participant in a lump sum on such New Payment Date, and any remaining payments will be paid on their original schedule.

The Company makes no representations or warranty and shall have no liability to the Participant or any other person if any provisions of or payments, compensation or other benefits under the Plan are determined to constitute nonqualified deferred compensation subject to Section 409A of the Code but do not to satisfy the conditions of that section.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g) <u>Limitations on Liability</u>. Notwithstanding any other provisions of the Plan, no individual acting as a director, officer, other employee, or agent of the Company will be liable to any Participant, former Participant, spouse, beneficiary, or any other person for any claim, loss, liability, or expense incurred

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in connection with the Plan, nor will such individual be personally liable with respect to the Plan because of any contract or other instrument such individual executes in such individual's capacity as a director, officer, other employee, or agent of the Company. The Company will indemnify and hold harmless each director, officer, other employee, or agent of the Company to whom any duty or power relating to the administration or interpretation of the Plan has been or will be delegated, against any cost or expense (including attorneys' fees) or liability (including any sum paid in settlement of a claim with the Board's approval) arising out of any act or omission to act concerning the Plan unless arising out of such person's own fraud or bad faith.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h) <u>Governing Law</u>. The provisions of the Plan and all Awards made hereunder shall be governed by and interpreted in accordance with the laws of the State of Delaware, excluding choice-of-law principles of the law of such state that would require the application of the laws of a jurisdiction other than the State of Delaware.

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**FAETH THERAPEUTICS, INC.**

**2019 STOCK INCENTIVE PLAN**

**CALIFORNIA SUPPLEMENT**

Pursuant to Section 11(e) of the Plan, the Board has adopted this supplement for purposes of satisfying the requirements of Section 25102(o) of the California Law:

Any Awards granted under the Plan to a Participant who is a resident of the State of California on the date of grant (a "California Participant") shall be subject to the following additional limitations, terms and conditions:

1. <u>Additional Limitations on Options</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) <u>Maximum Duration of Options</u>. No Options granted to California Participants shall have a term in excess of 10 years measured from the Option grant date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) <u>Minimum Exercise Period Following Termination</u>. Unless a California Participant's employment is terminated for cause (as defined by applicable law, the terms of the Plan or option grant or a contract of employment), in the event of termination of employment of such Participant, such Participant shall have the right to exercise an Option, to the extent that such Participant is entitled to exercise such Option on the date employment terminated, until the earlier of: (i) at least six months from the date of termination, if termination was caused by such Participant's death or disability, (ii) at least 30 days from the date of termination, if termination was caused other than by such Participant's death or disability and (iii) the Option expiration date.

2. <u>Additional Limitations for Other Stock-Based Awards</u>. The terms of all Awards granted to a California Participant under Section 8 of the Plan shall comply, to the extent applicable, with Section 260.140.46 of the California Code of Regulations.

3. <u>Additional Limitations on Timing of Awards</u>. No Award granted to a California Participant shall become exercisable, vested or realizable, as applicable to such Award, unless the Plan has been approved by the holders of a majority of the Company's outstanding voting securities by the later of (i) within 12 months before or after the date the Plan was adopted by the Board, or (ii) prior to or within 12 months of the granting of any Award to a California Participant.

4. <u>Additional Restriction Regarding Recapitalizations, Stock Splits, Etc.</u> For purposes of Section 9 of the Plan, in the event of a stock split, reverse stock split, stock dividend, recapitalization, combination, reclassification or other distribution of the Company's securities underlying the Award without the receipt of consideration by the Company, the number of securities purchasable, and in the case of Options, the exercise price of such Options, shall be proportionately adjusted.

5. <u>Additional Limitations on Transferability of Awards</u>. Notwithstanding the provisions of Section 10(a) of the Plan, an Award granted to a California Participant may not be transferred to an executor or guardian upon the disability of the Participant.

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**Faeth Therapeutics, Inc.<br>Stock Option Agreement<br>Granted Under 2019 Stock Incentive Plan**

This Stock Option Agreement (this "**Agreement**") is made between Faeth Therapeutics, Inc., a Delaware corporation (the "**Company**"), and the Participant pursuant to the 2019 Stock Incentive Plan (the "**Plan**").

**Notice of Grant**

**I. Participant Information**

<u>Participant:</u>   <br> <u>Participant Address:</u>  

**II. Grant Information**

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| | |
|:---|:---|
| &nbsp;&nbsp;Grant Date: |  |
| &nbsp;&nbsp;Number of Shares: |  |
| &nbsp;&nbsp;Exercise Price Per Share: |  |
| &nbsp;&nbsp;Vesting Commencement Date: |  |
| &nbsp;&nbsp;Type of Option: | &nbsp;&nbsp;[Incentive Stock Option][Nonstatutory Stock Option] |

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**III. Vesting Table**

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| |
|:---|
| &nbsp;&nbsp;Vesting Date<sup>1</sup> |
| &nbsp;&nbsp;[First] anniversary of the Vesting Commencement Date<br> &nbsp;&nbsp;[# of Shares]<sup>2</sup> |
| &nbsp;&nbsp;End of each successive [one] month period following the [First] anniversary of the Vesting Commencement Date until the [Fourth] anniversary of the Vesting Commencement Date<br> &nbsp;&nbsp;[# of Shares]<sup>3</sup> |

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<sup>(1)</sup> The number of shares is subject to adjustment for any changes in the Company's capitalization as set forth in Section 9 of the Plan.

**IV. Final Exercise Date**

<u>5:00 pm Eastern time on Date:</u> <u>[Date is ten years minus one day from Grant Date]</u>

This Agreement includes this Notice of Grant and the following Exhibits, which are expressly incorporated by reference in their entirety herein:

Exhibit A – General Terms and Conditions

Exhibit B – Notice of Stock Option Exercise

Exhibit C – Faeth Therapeutics, Inc. 2019 Stock Incentive Plan

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<sup>1</sup> Note: This is drafted assuming a four-year vesting schedule with a one-year cliff. If a different schedule is used, this table will need to be adjusted accordingly.

<sup>2</sup> Note: Number of Shares to equal 25% of total grant.

<sup>3</sup> Note: Number of Shares to equal 2.0833% of total grant.

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IN WITNESS WHEREOF, the parties hereto have executed this Agreement.

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| | | |
|:---|:---|:---|
| &nbsp;&nbsp;**FAETH THERAPEUTICS, INC.**<br>Name:<br>Title: | &nbsp;&nbsp;PARTICIPANT<br>Name:<br>| &nbsp;&nbsp;SPOUSAL CONSENT<sup>1</sup><br>Name:<br>|

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<sup>1</sup> If the Participant resides in a community property state, it is desirable to have the Participant's spouse also accept the option. The following are community property states: Arizona, California, Idaho, Louisiana, Nevada, New Mexico, Texas, and Washington. Although Wisconsin is not formally a community property state, it has laws governing the division of marital property similar to community property states and it may be desirable to have a Wisconsin Participant's spouse accept the option.

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**<u>Stock Option Agreement<br>2019 Stock Incentive Plan</u>**

**Exhibit A**

**General terms and Conditions**

For valuable consideration, receipt of which is acknowledged, the parties hereto agree as follows:

1. <u>Grant of Option</u>. This Agreement evidences the grant by the Company, on the grant date (the "**Grant Date**") set forth in the Notice of Grant that forms part of this Agreement (the "**Notice of Grant**"), to the Participant of an option to purchase, in whole or in part, on the terms provided herein and in the Company's 2019 Stock Incentive Plan (the "**Plan**"), the number of shares set forth in the Notice of Grant (the "**Shares**") of common stock, $0.0001 par value per share, of the Company ("**Common Stock**") at the exercise price per Share set forth in the Notice of Grant (the "**Exercise Price**"). Unless earlier terminated, this option shall expire at the time and on the date set forth in the Notice of Grant (the "**Final Exercise Date**").

It is intended that the option evidenced by this Agreement shall be an incentive stock option as defined in Section 422 of the Internal Revenue Code of 1986, as amended, and any regulations promulgated thereunder (the "**Code**") solely to the extent set forth in the Notice of Grant. To the extent not designated as an incentive stock option, or to the extent that the option does not qualify as an incentive stock option, the option shall be a nonstatutory stock option. Except as otherwise indicated by the context, the term "Participant", as used in this option, shall be deemed to include any person who acquires the right to exercise this option validly under its terms.

2. <u>Vesting Schedule</u>.

This option will become exercisable ("**vest**") in accordance with the Vesting Table set forth in the Notice of Grant.

The right of exercise shall be cumulative so that to the extent the option is not exercised in any period to the maximum extent permissible it shall continue to be exercisable, in whole or in part, with respect to all Shares for which it is vested until the earlier of the Final Exercise Date or the termination of this option under Section 3 hereof or the Plan.

3. <u>Exercise of Option</u>.

4. <u>Form of Exercise</u>. Each election to exercise this option shall be accompanied by a completed Notice of Stock Option Exercise in the form attached hereto as <u>Exhibit B</u>, signed by the Participant, and received by the Company at its principal office, accompanied by this Agreement, and payment in full in the manner provided in the Plan. The Participant may purchase less than the number of Shares covered hereby, provided that no partial exercise of this option may be for any fractional share or for fewer than ten whole shares (unless the

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number of Shares that remain subject to this option at the time of exercise is less than ten whole shares, in which case the Participant may purchase the total number of whole shares that remain subject to this option).

5. <u>Continuous Relationship with the Company Required</u>. Except as otherwise provided in this Section 3, this option may not be exercised unless the Participant, at the time he or she exercises this option, is, and has been at all times since the Grant Date, an employee, officer or director of, or consultant or advisor to, the Company or any parent or subsidiary of the Company as defined in Section 424(e) or (f) of the Code or any other entity the employees, officers, directors, consultants, or advisors of which are eligible to receive option grants under the Plan (an "**Eligible Participant**").

6. <u>Termination of Relationship with the Company</u>. If the Participant ceases to be an Eligible Participant for any reason, then, except as provided in paragraphs (d) and (e) below, the right to exercise this option shall terminate three months after such cessation (but in no event after the Final Exercise Date), <u>provided</u> <u>that</u> this option shall be exercisable only to the extent that the Participant was entitled to exercise this option on the date of such cessation. Notwithstanding the foregoing, if the Participant, prior to the Final Exercise Date, violates the non-competition or confidentiality provisions of any employment contract, confidentiality and nondisclosure agreement or other agreement between the Participant and the Company, the right to exercise this option shall terminate immediately upon such violation.

7. <u>Exercise Period Upon Death or Disability</u>. If the Participant dies or becomes disabled (within the meaning of Section 22(e)(3) of the Code) prior to the Final Exercise Date while he or she is an Eligible Participant and the Company has not terminated such service relationship for "**cause**" as specified in paragraph (e) below, this option shall be exercisable, within the period of one year following the date of death or disability of the Participant, by the Participant (or in the case of death by an authorized transferee), provided that this option shall be exercisable only to the extent that this option was exercisable by the Participant on the date of his or her death or disability, and further provided that this option shall not be exercisable after the Final Exercise Date.

8. <u>Termination for Cause</u>. If, prior to the Final Exercise Date, the Participant's service relationship with the Company is terminated by the Company for Cause (as defined below), the right to exercise this option shall terminate immediately upon the effective date of such termination. If, prior to the Final Exercise Date, the Participant is given notice by the Company of the termination of his or her service relationship by the Company for Cause, and the effective date of such termination is subsequent to the date of the delivery of such notice, the right to exercise this option shall be suspended from the time of the delivery of such notice until the earlier of (i) such time as it is determined or otherwise agreed that the Participant's service relationship shall not be terminated for Cause as provided in such notice or (ii) the effective date of such termination (in which case the right to exercise this option shall, pursuant to the preceding sentence, terminate immediately upon the effective date of such termination). If the Participant is party to an employment, consulting or severance agreement with the Company or subject to a severance plan maintained by the Company, in either case, that contains a definition of "cause" for termination of service, "Cause" shall have the meaning ascribed to such term in such agreement or plan. Otherwise, "Cause" shall

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mean willful misconduct by the Participant or willful failure by the Participant to perform his or her responsibilities to the Company (including, without limitation, breach by the Participant of any provision of any employment, consulting, advisory, nondisclosure, non-competition or other similar agreement between the Participant and the Company), as determined by the Company, which determination shall be conclusive. The Participant's service relationship shall be considered to have been terminated for "Cause" if the Company determines, within 30 days after the Participant's termination of service, that termination for Cause was warranted.

9. Company Right of First Refusal.

10. <u>Notice of Proposed Transfer</u>. If the Participant proposes to sell, assign, transfer, pledge, hypothecate or otherwise dispose of, by operation of law or otherwise (collectively, "**transfer**") any Shares acquired upon exercise of this option, then the Participant shall first give written notice of the proposed transfer (the "**Transfer Notice**") to the Company. The Transfer Notice shall name the proposed transferee and state the number of such Shares the Participant proposes to transfer (the "**Offered Shares**"), the price per share and all other material terms and conditions of the transfer.

11. <u>Company Right to Purchase</u>. For 30 days following its receipt of such Transfer Notice, the Company shall have the option to purchase all or part of the Offered Shares at the price and upon the terms set forth in the Transfer Notice. In the event the Company elects to purchase all or part of the Offered Shares, it shall give written notice of such election to the Participant within such 30-day period. Within 10 days after his or her receipt of such notice, the Participant shall tender to the Company at its principal offices the certificate or certificates representing the Offered Shares to be purchased by the Company, duly endorsed in blank by the Participant or with duly endorsed stock powers attached thereto, all in a form suitable for transfer of the Offered Shares to the Company. Promptly following receipt of such certificate or certificates, the Company shall deliver or mail to the Participant a check in payment of the purchase price for such Offered Shares; <u>provided</u> <u>that</u> if the terms of payment set forth in the Transfer Notice were other than cash against delivery, the Company may pay for the Offered Shares on the same terms and conditions as were set forth in the Transfer Notice; and <u>provided</u> <u>further</u> that any delay in making such payment shall not invalidate the Company's exercise of its option to purchase the Offered Shares.

12. <u>Shares Not Purchased By Company</u>. If the Company does not elect to acquire all of the Offered Shares, the Participant may, within the 30-day period following the expiration of the option granted to the Company under subsection (b) above, transfer the Offered Shares which the Company has not elected to acquire to the proposed transferee, <u>provided</u> <u>that</u> such transfer shall not be on terms and conditions more favorable to the transferee than those contained in the Transfer Notice. Notwithstanding any of the above, all Offered Shares transferred pursuant to this Section 4 shall remain subject to the right of first refusal set forth in this Section 4 and such transferee shall, as a condition to such transfer, deliver to the Company a written instrument confirming that such transferee shall be bound by all of the terms and conditions of this Section 4.

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13. <u>Consequences of Non-Delivery</u>. After the time at which the Offered Shares are required to be delivered to the Company for transfer to the Company pursuant to subsection (b) above, the Company shall not pay any dividend to the Participant on account of such Offered Shares or permit the Participant to exercise any of the privileges or rights of a stockholder with respect to such Offered Shares, but shall, insofar as permitted by law, treat the Company as the owner of such Offered Shares.

14. <u>Exempt Transactions</u>. The following transactions shall be exempt from the provisions of this Section 4:

15. any transfer of Shares to or for the benefit of any spouse, child or grandchild of the Participant, or to a trust for their benefit;

16. any transfer pursuant to an effective registration statement filed by the Company under the Securities Act of 1933, as amended (the "**Securities Act**"); and

17. the sale of all or substantially all of the outstanding shares of capital stock of the Company (including pursuant to a merger or consolidation); <u>provided</u>, <u>however</u>, that in the case of a transfer pursuant to clause (1) above, such Shares shall remain subject to the right of first refusal set forth in this Section 4.

18. <u>Assignment of Company Right</u>. The Company may assign its rights to purchase Offered Shares in any particular transaction under this Section 4 to one or more persons or entities.

19. <u>Termination</u>. The provisions of this Section 4 shall terminate upon the earlier of the following events:

20. the closing of the sale of shares of Common Stock in an underwritten public offering pursuant to an effective registration statement filed by the Company under the Securities Act; or

21. the sale of all or substantially all of the outstanding shares of capital stock, assets or business of the Company, by merger, consolidation, sale of assets or otherwise (other than a merger or consolidation in which all or substantially all of the individuals and entities who were beneficial owners of the Company's voting securities immediately prior to such transaction beneficially own, directly or indirectly, more than 50% (determined on an as-converted basis) of the outstanding securities entitled to vote generally in the election of directors of the resulting, surviving or acquiring corporation in such transaction).

22. <u>No Obligation to Recognize Invalid Transfer</u>. The Company shall not be required (1) to transfer on its books any of the Shares which shall have been sold or transferred in violation of any of the provisions set forth in this Section 4, or (2) to treat as owner of such Shares or to pay dividends to any transferee to whom any such Shares shall have been so sold or transferred.

23. <u>Legends</u>. The certificate representing Shares shall bear a legend substantially in the following form (in addition to, or in combination with, any legend required by applicable federal and state securities laws and agreements relating to the transfer of the Company securities):

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"The shares represented by this certificate are subject to a right of first refusal in favor of the Company, as provided in a certain stock option agreement with the Company."

24. <u>Agreement in Connection with Initial Public Offering</u>.

The Participant agrees, in connection with the initial underwritten public offering of the Common Stock pursuant to a registration statement under the Securities Act, (i) not to (a) offer, pledge, announce the intention to sell, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any shares of Common Stock or any other securities of the Company or (b) enter into any swap or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of shares of Common Stock or other securities of the Company, whether any transaction described in clause (a) or (b) is to be settled by delivery of securities, in cash or otherwise, during the period beginning on the date of the filing of such registration statement with the Securities and Exchange Commission and ending 180 days after the date of the final prospectus relating to the offering (plus up to an additional 34 days to the extent requested by the managing underwriters for such offering in order to address NASD Rule 2711(f)(4) or NYSE Rule 472(f)(4) or any similar successor provision), and (ii) to execute any agreement reflecting clause (i) above as may be requested by the Company or the managing underwriters at the time of such offering. The Company may impose stop-transfer instructions with respect to the shares of Common Stock or other securities subject to the foregoing restriction until the end of the "lock-up" period.

25. <u>Tax Matters</u>.

26. <u>Withholding</u>. No Shares will be issued pursuant to the exercise of this option unless and until the Participant pays to the Company, or makes provision satisfactory to the Company for payment of, any federal, state or local withholding taxes required by law to be withheld in respect of this option.

27. <u>Disqualifying Disposition</u>. If this option satisfies the requirements to be treated as an incentive stock option under the Code and the Participant disposes of Shares acquired upon exercise of this option within two years from the Grant Date or one year after such Shares were acquired pursuant to exercise of this option, the Participant shall notify the Company in writing of such disposition.

28. <u>Transfer Restrictions</u>.

29. This option may not be sold, assigned, transferred, pledged or otherwise encumbered by the Participant, either voluntarily or by operation of law, except by will or the - 5 - laws of descent and distribution, and, during the lifetime of the Participant, this option shall be exercisable only by the Participant.

30. The Participant agrees that he or she will not transfer any Shares issued pursuant to the exercise of this option unless the transferee, as a condition to such transfer, delivers to the Company a written instrument confirming that such transferee shall be bound by all of the terms and conditions of Section 4 and Section 5; provided that such a written confirmation

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shall not be required with respect to (1) Section 4 after such provision has terminated in accordance with Section 4(g) or (2) Section 5 after the completion of the lock-up period in connection with the Company's initial underwritten public offering.

31. <u>Provisions of the Plan</u>.

This option is subject to the provisions of the Plan (including the provisions relating to amendments to the Plan), a copy of which is attached hereto as <u>Exhibit C</u>.

[Remainder of Page Intentionally Left Blank]

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**Exhibit B**

**Notice of Stock Option Exercise**

[DATE]<sup>1</sup>

Faeth Therapeutics, Inc.

[Address]

[Address]

Attention: Treasurer

Dear Sir or Madam:

I am the holder of [________]<sup>2</sup> Stock Option granted to me under the Faeth Therapeutics, Inc. (the "**Company**") 2019 Stock Incentive Plan on [________]<sup>3</sup> for the purchase of [________]<sup>4</sup> shares of Common Stock of the Company at a purchase price of $[________]<sup>5</sup> per share.

I hereby exercise my option to purchase [________]<sup>6</sup> shares of Common Stock (the "**Shares**"), for which I have enclosed [________]<sup>7</sup> in the amount of [________]<sup>8</sup> register my stock certificate as follows:

Name(s): <sup>9</sup>

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<sup>1</sup> Enter date of exercise.

<sup>2</sup> Enter either "an Incentive" or "a Nonstatutory" or both.

<sup>3</sup> Enter the date of grant.

<sup>4</sup> Enter the total number of shares of Common Stock for which the option was granted.

<sup>5</sup> Enter the option exercise price per share of Common Stock.

<sup>6</sup> Enter the number of shares of Common Stock to be purchased upon exercise of all or part of the option.

<sup>7</sup> Enter "cash", "personal check" or if permitted by the option or Plan, "stock certificates No. XXXX and XXXX".

<sup>8</sup> Enter the dollar amount (price per share of Common Stock times the number of shares of Common Stock to be purchased), or the number of shares tendered. Fair market value of shares tendered, together with cash or check, must cover the purchase price of the shares issued upon exercise.

<sup>9</sup> Enter name(s) to appear on stock certificate in one of the following formats: (a) your name only (i.e., John Doe); (b) your name and other name (i.e., John Doe and Jane Doe, Joint Tenants with Right to Survivorship); or for Nonstatutory Stock Options only, (c) a child's name, with you as custodian (i.e. Jane Doe, Custodian for Tommy Doe). Note: There may be income and/or gift tax consequences for registering shares in a child's name.

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&nbsp;&nbsp;Address:<br>

I represent, warrant and covenant as follows:

1. I am purchasing the Shares for my own account for investment only, and not with a view to, or for sale in connection with, any distribution of the Shares in violation of the Securities Act of 1933 (the "**Securities Act**"), or any rule or regulation under the Securities Act.

2. I have had such opportunity as I have deemed adequate to obtain from representatives of the Company such information as is necessary to permit me to evaluate the merits and risks of my investment in the Company.

3. I have sufficient experience in business, financial and investment matters to be able to evaluate the risks involved in the purchase of the Shares and to make an informed investment decision with respect to such purchase.

4. I can afford a complete loss of the value of the Shares and am able to bear the economic risk of holding such Shares for an indefinite period.

5. I understand that (i) the Shares have not been registered under the Securities Act and are "restricted securities" within the meaning of Rule 144 under the Securities Act, (ii) the Shares cannot be sold, transferred or otherwise disposed of unless they are subsequently registered under the Securities Act or an exemption from registration is then available; (iii) in any event, the exemption from registration under Rule 144 will not be available for at least six months and even then will not be available unless a public market then exists for the Common Stock, adequate information concerning the Company is then available to the public, and other terms and conditions of Rule 144 are complied with; and (iv) there is now no registration statement on file with the Securities and Exchange Commission with respect to any stock of the Company and the Company has no obligation or current intention to register the Shares under the Securities Act.

[By the execution and delivery of this Notice of Stock Option Exercise, I shall be, and hereby agree to be, bound by the (i) [Amended and Restated] Voting Agreement, dated [_________], by and among the Company and the other signatories thereto (the "**Voting Agreement**"), as a ["Key Holder" and "Stockholder"] (each as defined in the Voting Agreement) for all purposes under the Voting Agreement and (ii) [Amended and Restated] Right of First Refusal and Co-Sale Agreement, dated [_________], by and among the Company and the other signatories thereto (the "**ROFR and Co-Sale Agreement**"), as a ["Key Holder"] (as defined in the ROFR and Co- Sale Agreement) for all purposes under the ROFR and Co-Sale Agreement. In addition to the foregoing, I shall execute and deliver to the Company (i) an [Adoption Agreement] in the form attached to the Voting Agreement, thereby agreeing to be bound by and subject to the terms of the Voting Agreement as a ["Key Holder" and "Stockholder"] (each as defined in the Voting Agreement) and (ii) a [counterpart signature page] to the ROFR and Co-Sale Agreement, thereby agreeing to be bound by and subject to the terms of the ROFR and Co-Sale Agreement as a ["Key Holder"] (as

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defined in the ROFR and Co-Sale Agreement). I acknowledge and agree that I have received a copy of the Voting Agreement and the Right of First Refusal and Co-Sale Agreement.]<sup>1</sup>

Very truly yours,

[Name]

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<sup>1</sup> This provision should be included if the Company is party to a Voting Agreement and/or Right of First Refusal and Co-Sale Agreement and pursuant to the terms of such Voting Agreement and/or Right of First Refusal and Co- Sale Agreement, the Participant is required to be a party to, and be bound by, the Voting Agreement and/or Right of First Refusal and Co-Sale Agreement. The defined terms in this section should be revised to correspond to the defined terms in the Voting Agreement or Right of First Refusal and Co-Sale Agreement (as applicable). In addition, the Participant should receive a copy of the Voting Agreement and/or Right of First Refusal and Co-Sale Agreement and also execute and deliver the Adoption Agreement (or similar agreement) pursuant to the terms of the Voting Agreement and a counterpart signature page to the Right of First Refusal and Co-Sale Agreement.

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**Exhibit C**

**Faeth Therapeutics, Inc. 2019 Stock Incentive Plan**

\* \* \* \*

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**Faeth Therapeutics, Inc.<br>Stock Option Agreement – Non-U.S.<br>Granted Under 2019 Stock Incentive Plan**

This Stock Option Agreement (this "**Agreement**") is made between Faeth Therapeutics, Inc., a Delaware corporation (the "**Company**"), and the Participant pursuant to the 2019 Stock Incentive Plan (the "**Plan**").

**Notice of Grant**

**I. Participant Information**

<u>Participant:</u>   <br> <u>Participant Address:</u>  

**II. Grant Information**

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| | |
|:---|:---|
| &nbsp;&nbsp;Grant Date: |  |
| &nbsp;&nbsp;Number of Shares: |  |
| &nbsp;&nbsp;Exercise Price Per Share (US$): |  |
| &nbsp;&nbsp;Vesting Commencement Date: |  |
| &nbsp;&nbsp;Type of Option: | &nbsp;&nbsp;[Nonstatutory Stock Option] |

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**III. Vesting Table**

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| |
|:---|
| &nbsp;&nbsp;Vesting Date<sup>1</sup> |
| &nbsp;&nbsp;[First] anniversary of the Vesting Commencement Date<br> &nbsp;&nbsp;[# of Shares]<sup>2</sup> |
| &nbsp;&nbsp;End of each successive [one] month period following the [First] anniversary of the Vesting Commencement Date until the [Fourth] anniversary of the Vesting Commencement Date<br> &nbsp;&nbsp;[# of Shares]<sup>3</sup> |

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<sup>(1)</sup> The number of shares is subject to adjustment for any changes in the Company's capitalization as set forth in Section 9 of the Plan.

**IV. Final Exercise Date**

<u>5:00 pm Eastern time on Date:</u> <u>[Date is ten years minus one day from Grant Date]</u>

This Agreement (the definition of which shall include any special terms and conditions for the Participant's country of residence and/or work set forth in the appendix attached hereto (the "**Appendix**")) includes this Notice of Grant and the following Exhibits, which are expressly incorporated by reference in their entirety herein:

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<sup>1</sup> Note: This is drafted assuming a four-year vesting schedule with a one-year cliff. If a different schedule is used, this table will need to be adjusted accordingly.

<sup>2</sup> Note: Number of Shares to equal 25% of total grant.

<sup>3</sup> Note: Number of Shares to equal 2.0833% of total grant.

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Exhibit A – General Terms and Conditions – Non-U.S. (including the Appendix)

Exhibit B – Notice of Stock Option Exercise – Non-U.S.

Exhibit C – Faeth Therapeutics, Inc. 2019 Stock Incentive Plan

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IN WITNESS WHEREOF, the parties hereto have executed this Agreement.

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| | |
|:---|:---|
| &nbsp;&nbsp;**FAETH THERAPEUTICS, INC.**<br>Name:<br>Title: | &nbsp;&nbsp;**PARTICIPANT**<br>Name:<br>|

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**<u>Stock Option Agreement<br>2019 Stock Incentive Plan</u>**

**Exhibit A**

**General terms and Conditions – Non-U.S.**

For valuable consideration, receipt of which is acknowledged, the parties hereto agree as follows:

6. <u>Grant of Option</u>. This Agreement (the definition of which shall include any special terms and conditions for Participant's country of residence and/or work set forth in the appendix attached hereto (the "**Appendix**")) evidences the grant by the Company, on the grant date (the "**Grant Date**") set forth in the Notice of Grant that forms part of this Agreement (the "**Notice of Grant**"), to the Participant of an option to purchase, in whole or in part, on the terms provided herein and in the Company's 2019 Stock Incentive Plan (the "**Plan**"), the number of shares set forth in the Notice of Grant (the "**Shares**") of common stock, $0.0001 par value per share, of the Company ("**Common Stock**") at the exercise price per Share set forth in the Notice of Grant (the "**Exercise Price**"). Unless earlier terminated, this option shall expire at the time and on the date set forth in the Notice of Grant (the "**Final Exercise Date**").

Except as otherwise indicated by the context, the term "**Participant**", as used in this option, shall be deemed to include any person who acquires the right to exercise this option validly under its terms.

7. <u>Vesting Schedule</u>.

This option will become exercisable ("**vest**") in accordance with the Vesting Table set forth in the Notice of Grant.

The right of exercise shall be cumulative so that to the extent the option is not exercised in any period to the maximum extent permissible it shall continue to be exercisable, in whole or in part, with respect to all Shares for which it is vested until the earlier of the Final Exercise Date or the termination of this option under Section 3 hereof or the Plan.

8. <u>Exercise of Option</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) <u>Form of Exercise</u>. Each election to exercise this option shall be accompanied by a completed Notice of Stock Option Exercise in the form attached hereto as <u>Exhibit B</u>, signed by the Participant, and received by the Company at its principal office, accompanied by this Agreement, and payment in full in the manner provided in the Plan. The Participant may purchase less than the number of Shares covered hereby, provided that no partial exercise of this option may be for any fractional share or for fewer than ten whole shares (unless the number of Shares that remain subject to this option at the time of exercise is less than ten whole shares, in which case the Participant may purchase the total number of whole shares that remain subject to this option).

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) <u>Continuous Relationship with the Company Required</u>. Except as otherwise provided in this Section 3, this option may not be exercised unless the Participant, at the time he or she exercises this option, is, and has been at all times since the Grant Date, an employee, officer or director of, or consultant or advisor to, the Company or any parent or subsidiary of the Company as defined in Section 424(e) or (f) of the Code or any other entity the employees, officers, directors, consultants, or advisors of which are eligible to receive option grants under the Plan (an "**Eligible Participant**").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) <u>Termination of Relationship with the Company</u>. If the Participant ceases to be an Eligible Participant for any reason, then, except as provided in paragraphs (d) and (e) below, the right to exercise this option shall terminate three months after such cessation (but in no event after the Final Exercise Date), <u>provided</u> <u>that</u> this option shall be exercisable only to the extent that the Participant was entitled to exercise this option on the date of such cessation. Notwithstanding the foregoing, if the Participant, prior to the Final Exercise Date, violates the non-competition or confidentiality provisions of any employment contract, confidentiality and nondisclosure agreement or other agreement between the Participant and the Company, the right to exercise this option shall terminate immediately upon such violation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) <u>Exercise Period Upon Death or Disability</u>. If the Participant dies or becomes disabled (within the meaning of Section 22(e)(3) of the Code) prior to the Final Exercise Date while he or she is an Eligible Participant and the Company has not terminated such service relationship for "**cause**" as specified in paragraph (e) below, this option shall be exercisable, within the period of one year following the date of death or disability of the Participant, by the Participant (or in the case of death by an authorized transferee), provided that this option shall be exercisable only to the extent that this option was exercisable by the Participant on the date of his or her death or disability, and further provided that this option shall not be exercisable after the Final Exercise Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) <u>Termination for Cause</u>. If, prior to the Final Exercise Date, the Participant's service relationship with the Company is terminated by the Company for Cause (as defined below), the right to exercise this option shall terminate immediately upon the effective date of such termination. If, prior to the Final Exercise Date, the Participant is given notice by the Company of the termination of his or her service relationship by the Company for Cause, and the effective date of such termination is subsequent to the date of the delivery of such notice, the right to exercise this option shall be suspended from the time of the delivery of such notice until the earlier of (i) such time as it is determined or otherwise agreed that the Participant's service relationship shall not be terminated for Cause as provided in such notice or (ii) the effective date of such termination (in which case the right to exercise this option shall, pursuant to the preceding sentence, terminate immediately upon the effective date of such termination). If the Participant is party to an employment, consulting or severance agreement with the Company or subject to a severance plan maintained by the Company, in either case, that contains a definition of "cause" for termination of service, "Cause" shall have the meaning ascribed to such term in such agreement or plan. Otherwise, "Cause" shall mean willful misconduct by the Participant or willful failure by the Participant to perform his or her responsibilities to the Company (including, without limitation, breach by the Participant of any provision of any employment, consulting, advisory, nondisclosure, non-competition or other similar agreement between the Participant and the Company), as determined by the Company, which determination shall be conclusive. The Participant's service

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relationship shall be considered to have been terminated for "Cause" if the Company determines, within 30 days after the Participant's termination of service, that termination for Cause was warranted.

9. <u>Company Right of First Refusal</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) <u>Notice of Proposed Transfer</u>. If the Participant proposes to sell, assign, transfer, pledge, hypothecate or otherwise dispose of, by operation of law or otherwise (collectively, "**transfer**") any Shares acquired upon exercise of this option, then the Participant shall first give written notice of the proposed transfer (the "**Transfer Notice**") to the Company. The Transfer Notice shall name the proposed transferee and state the number of such Shares the Participant proposes to transfer (the "**Offered Shares**"), the price per share and all other material terms and conditions of the transfer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) <u>Company Right to Purchase</u>. For 30 days following its receipt of such Transfer Notice, the Company shall have the option to purchase all or part of the Offered Shares at the price and upon the terms set forth in the Transfer Notice. In the event the Company elects to purchase all or part of the Offered Shares, it shall give written notice of such election to the Participant within such 30-day period. Within 10 days after his or her receipt of such notice, the Participant shall tender to the Company at its principal offices the certificate or certificates representing the Offered Shares to be purchased by the Company, duly endorsed in blank by the Participant or with duly endorsed stock powers attached thereto, all in a form suitable for transfer of the Offered Shares to the Company. Promptly following receipt of such certificate or certificates, the Company shall deliver or mail to the Participant a check in payment of the purchase price for such Offered Shares; <u>provided that</u> if the terms of payment set forth in the Transfer Notice were other than cash against delivery, the Company may pay for the Offered Shares on the same terms and conditions as were set forth in the Transfer Notice; and <u>provided</u> <u>further</u> that any delay in making such payment shall not invalidate the Company's exercise of its option to purchase the Offered Shares.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) <u>Shares Not Purchased By Company</u>. If the Company does not elect to acquire all of the Offered Shares, the Participant may, within the 30-day period following the expiration of the option granted to the Company under subsection (b) above, transfer the Offered Shares which the Company has not elected to acquire to the proposed transferee, <u>provided that</u> such transfer shall not be on terms and conditions more favorable to the transferee than those contained in the Transfer Notice. Notwithstanding any of the above, all Offered Shares transferred pursuant to this Section 4 shall remain subject to the right of first refusal set forth in this Section 4 and such transferee shall, as a condition to such transfer, deliver to the Company a written instrument confirming that such transferee shall be bound by all of the terms and conditions of this Section 4.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) <u>Consequences of Non-Delivery</u>. After the time at which the Offered Shares are required to be delivered to the Company for transfer to the Company pursuant to subsection (b) above, the Company shall not pay any dividend to the Participant on account of such Offered Shares or permit the Participant to exercise any of the privileges or rights of a stockholder with respect to such Offered Shares, but shall, insofar as permitted by law, treat the Company as the owner of such Offered Shares.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) <u>Exempt Transactions</u>. The following transactions shall be exempt from the provisions of this Section 4:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) any transfer of Shares to or for the benefit of any spouse, child or grandchild of the Participant, or to a trust for their benefit;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) any transfer pursuant to an effective registration statement filed by the Company under the Securities Act of 1933, as amended (the "**Securities Act**"); and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(3) the sale of all or substantially all of the outstanding shares of capital stock of the Company (including pursuant to a merger or consolidation); <u>provided</u>, <u>however</u>, that in the case of a transfer pursuant to clause (1) above, such Shares shall remain subject to the right of first refusal set forth in this Section 4.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) <u>Assignment of Company Right</u>. The Company may assign its rights to purchase Offered Shares in any particular transaction under this Section 4 to one or more persons or entities.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g) <u>Termination</u>. The provisions of this Section 4 shall terminate upon the earlier of the following events:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) the closing of the sale of shares of Common Stock in an underwritten public offering pursuant to an effective registration statement filed by the Company under the Securities Act; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) the sale of all or substantially all of the outstanding shares of capital stock, assets or business of the Company, by merger, consolidation, sale of assets or otherwise (other than a merger or consolidation in which all or substantially all of the individuals and entities who were beneficial owners of the Company's voting securities immediately prior to such transaction beneficially own, directly or indirectly, more than 50% (determined on an as-converted basis) of the outstanding securities entitled to vote generally in the election of directors of the resulting, surviving or acquiring corporation in such transaction).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h) No Obligation to Recognize Invalid Transfer. The Company shall not be required (1) to transfer on its books any of the Shares which shall have been sold or transferred in violation of any of the provisions set forth in this Section 4, or (2) to treat as owner of such Shares or to pay dividends to any transferee to whom any such Shares shall have been so sold or transferred.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) <u>Legends</u>. The certificate representing Shares shall bear a legend substantially in the following form (in addition to, or in combination with, any legend required by applicable federal and state securities laws and agreements relating to the transfer of the Company securities):

"The shares represented by this certificate are subject to a right of first refusal in favor of the Company, as provided in a certain stock option agreement with the Company."

10. <u>Agreement in Connection with Initial Public Offering</u>.

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The Participant agrees, in connection with the initial underwritten public offering of the Common Stock pursuant to a registration statement under the Securities Act, (i) not to (a) offer, pledge, announce the intention to sell, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any shares of Common Stock or any other securities of the Company or (b) enter into any swap or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of shares of Common Stock or other securities of the Company, whether any transaction described in clause (a) or (b) is to be settled by delivery of securities, in cash or otherwise, during the period beginning on the date of the filing of such registration statement with the Securities and Exchange Commission and ending 180 days after the date of the final prospectus relating to the offering (plus up to an additional 34 days to the extent requested by the managing underwriters for such offering in order to address NASD Rule 2711(f)(4) or NYSE Rule 472(f)(4) or any similar successor provision), and (ii) to execute any agreement reflecting clause (i) above as may be requested by the Company or the managing underwriters at the time of such offering. The Company may impose stop-transfer instructions with respect to the shares of Common Stock or other securities subject to the foregoing restriction until the end of the "lock-up" period.

11. <u>Tax Matters</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) <u>Withholding</u>. No Shares will be issued pursuant to the exercise of this option unless and until the Participant pays to the Company, or makes provision satisfactory to the Company for payment of, any federal, state or local withholding and social security taxes required by law to be withheld in respect of this option.

12. <u>Transfer Restrictions</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) This option may not be sold, assigned, transferred, pledged or otherwise encumbered by the Participant, either voluntarily or by operation of law, except to the Participant's personal representative on Participant's death, and, during the lifetime of the Participant, this option shall be exercisable only by the Participant or the Participant's personal representative after Participant's death.

13. <u>Option not a Service Contract</u>. By accepting the option, the Participant acknowledges, understands and agrees that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) the Participant's option is not an employment or service contract, and, if the Participant is an employee of the Company or an affiliate, nothing in the Participant's option will be deemed to create in any way whatsoever any obligation on the Participant's part to continue as an employee of the Company or an affiliate, or of the Company or an affiliate to continue Participant's employment. In addition, nothing in the Participant's option will obligate the Company or an affiliate, or their respective stockholders, boards of directors, officers or employees to continue any relationship that the Participant might have as a director or consultant for the Company or an affiliate;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) the Plan is established voluntarily by the Company, it is discretionary in nature, and may be amended, suspended or terminated by the Company at any time, to the extent permitted under the Plan;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) the grant of the Participant's option is voluntary and occasional and does not create any contractual or other right to receive future grants of options (whether on the same or different terms), or benefits in lieu of options, even if options have been granted in the past;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) the Participant's options and any shares of Common Stock acquired under the Plan on exercise of the Participant's options, and the income and value of same, are not part of normal or expected compensation for any purpose, including, without limitation, calculating any severance, resignation, termination, vacation, redundancy, dismissal, end-of-service payments, bonuses, long-service awards, pension or retirement or welfare benefits or similar payments;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) the future value of the shares of Common Stock underlying the option is unknown, indeterminable, and cannot be predicted with certainty;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) neither the Company nor any affiliate shall be liable for any foreign exchange rate fluctuation between the Participant's local currency and the United States Dollar that may affect the value of the Participant's options or of any amounts due to Participant pursuant to the exercise of the Participant's option or the subsequent sale of any shares of Common Stock received;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g) notwithstanding anything to the contrary in the Plan, for the purposes of the option, the Participant's service will be considered terminated as of the date the Participant is no longer actively providing services to the Company or one of its affiliates (regardless of the reason for such termination and whether or not later found to be invalid or in breach of employment laws in the jurisdiction where the Participant is employed or is otherwise providing services, or the terms of the Participant's employment or service agreement, if any), provided that, unless otherwise expressly provided in this Agreement or determined by the Company, the vesting of the Participant's option will not continue during any notice period or any period of "garden leave" or similar period mandated under employment laws in the jurisdiction where the Participant is employed or where the Participant is otherwise providing services, or the terms of the Participant's employment or service agreement, if any (regardless, in each case, of whether or not the Participant is providing services to the Company or one of its affiliates during such notice period, garden leave period, or similar period); and the Board shall have the exclusive discretion to determine when the Participant is no longer actively providing services for purposes of the option (including whether the Participant may still be considered to be providing services while on a leave of absence); and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h) no claim or entitlement to compensation or damages shall arise from forfeiture of this option resulting from the termination of the Participant's service (for any reason whatsoever, whether or not later found to be invalid or in breach of employment laws in the jurisdiction where the Participant is employed or is otherwise providing services, or the terms of the Participant's employment or service agreement, if any), and in consideration of the grant of this option to which Participant is otherwise not entitled, the Participant irrevocably agrees never to institute any claim against the Company or any affiliate, waive the Participant's ability, if any, to bring any such claim, and release the Company and any affiliate from any such claim; if, notwithstanding the foregoing, any such claim is allowed by a court of competent jurisdiction, then, by participating in

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the Plan, the Participant shall be deemed irrevocably to have agreed not to pursue such claim and agree to execute any and all documents necessary to request dismissal or withdrawal of such claim.

14. <u>No Advice Regarding Grant</u>. The Company is not providing any tax, legal or financial advice, nor is the Company making any recommendations regarding the Participant's participation in the Plan, or the Participant's acquisition or sale of the underlying shares of Common Stock. The Participant should consult with the Participant's own personal tax, legal and financial advisors regarding the Participant's participation in the Plan before taking any action.

15. <u>Data Privacy</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) To the extent that the processing of the Participant's personal data by the Company or its affiliates under and/or in connection with this Agreement falls within the territorial scope of (i) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27th April 2016 (the "**EU GDPR**"), (ii) the EU GDPR as it forms part of UK law by virtue of section 3 of the European Union (Withdrawal) Act 2018, as amended (the "**UK GDPR**"), and/or (iii) equivalent legislation and/or legislation implementing and/or supplementing the EU GDPR or UK GDPR in any member state of the European Economic Area or the UK or Switzerland, Company and/or its affiliates will carry out such processing in accordance with their EEA/UK privacy notice from time to time in force, the latest version of which has been provided to the Participant.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Except where (a) above applies, the Participant explicitly and unambiguously acknowledges and consents to the collection, use, transfer and other processing of the Participant's personal data as described in this paragraph (b) by the Company and its affiliates for the purpose of implementing, administering and managing the Participant's participation in the Plan. The Participant understands that the Company and its affiliates hold certain personal data about the Participant, including, but not limited to, the Participant's name, home address, telephone number, date of birth, social security number (or other identification number), salary, nationality, job title, any shares of stock or directorships held by the Participant in the Company, details of all options or any other entitlement to shares of Common Stock awarded, cancelled, purchased, exercised, vested, unvested or outstanding in the Participant's favor for the purpose of implementing, managing and administering the Plan. The Participant understands that this personal data may be transferred to any third parties assisting in the implementation, administration and management of the Plan.

16. <u>Language</u>. The Participant acknowledges that the Participant is sufficiently proficient in the English language, or has consulted with an advisor who is sufficiently proficient in English, so as to allow the Participant to understand the terms and conditions of this Agreement. If the Participant has received this Agreement, or any other document related to the Participant's option and/or the Plan translated into a language other than English and if the meaning of the translated version is different than the English version, the English version will control.

17. <u>Foreign Asset/Account, Exchange Control and Tax Reporting</u>. The Participant may be subject to foreign asset/account, exchange control and/or tax reporting requirements as a result of the acquisition, holding and/or transfer of shares of Common Stock or cash (including dividends and the proceeds arising from the sale of shares of Common Stock) derived from the Participant's participation in the Plan in, to and/or from a brokerage/bank account or legal entity located outside

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the Participant's country of residence. The applicable laws in the Participant's country of residence may require that the Participant reports such accounts, assets and balances therein, the value thereof and/or the transactions related thereto to the applicable authorities in such country. The Participant may also be required to repatriate sale proceeds or other funds received as a result of the Participant's participation in the Plan to the Participant's country of residence through a designated bank or broker within a certain time after receipt. The Participant acknowledges that it is the Participant's responsibility to be compliant with such regulations and the Participant is encouraged to consult with the Participant's personal legal advisor for any details.

18. <u>Applicable Law</u>. In the event applicable laws prevent or hinder the consummation of the actions and transactions contemplated in this Agreement or the Plan, the Company may in its sole discretion agree to vary the terms of the Plan and/or this Agreement so that the Participant receives substantially the same economic result as contemplated herein, such as through a cashless sell to cover exercise (provided that at the time of exercise the shares of Common Stock are publicly traded or otherwise liquid), a cash bonus or phantom stock.

19. <u>Appendix</u>. Notwithstanding any provisions in this Agreement, the Participant's option shall be subject to the special terms and conditions for the Participant's country of residence and/or work set forth in the Appendix attached to this Agreement which, where applicable, shall prevail in the event of conflict between such terms and conditions and the terms of this Agreement, Notice of Grant, and/or the Plan. Moreover, if the Participant relocates to one of the countries included therein, the terms and conditions for such country will apply to the Participant to the extent the Company determines that the application of such terms and conditions is necessary or advisable for legal or administrative reasons. The Appendix constitutes part of this Agreement.

20. <u>Choice of Law</u>. The provisions of the Plan relating to choice of law shall apply to this Agreement and the option.

21. <u>Provisions of the Plan</u>.

This option is subject to the provisions of the Plan (including the provisions relating to amendments to the Plan), a copy of which is attached hereto as Exhibit C.

*[Remainder of Page Intentionally Left Blank]*

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**APPENDIX TO AGREEMENT**

This Appendix includes special terms and conditions that govern the option granted to the Participant under the Plan if the Participant resides and/or works in one of the countries listed below.

The information contained herein is general in nature and may not apply to the Participant's particular situation, and the Participant is advised to seek appropriate professional advice as to how the relevant laws in the Participant's country may apply to the Participant's situation. If the Participant is a citizen or resident of a country other than the one in which the Participant is currently working and/or residing, transfer employment and/or residency to another country after the Grant Date, is a consultant, change employment status to a consultant position, or is considered a resident of another country for local law purposes, the Company shall, in its discretion, determine the extent to which the special terms and conditions contained herein shall be applicable to the Participant. References to the Participant's employer shall include any entity that engages the Participant's services.

**India**

The following provisions govern Participant's participation in the Plan if Participant is a person resident in India. It is clarified that the Company reserves the right to apply any or all of the following provisions to individuals who are not Indian citizens/nationals, but considered as persons resident in India, to the extent it determines necessary or advisable under applicable Indian laws.

**Compliance with Law.** By accepting the option and accepting the terms of the Agreement, Participant acknowledges and agrees to comply with all applicable Indian laws and pay any and all applicable taxes associated with the option, the sale of shares of Common Stock acquired under the Plan, and the receipt of any dividends paid on such shares of Common Stock.

**Exercise Restriction.** The following supplements the Notice of Grant, the Agreement and the Plan.

Participant must comply at the time of exercise with applicable laws and regulations of India, including but not limited to the Foreign Exchange Management Act, 1999 of India and the rules, regulations and amendments thereto, including the Foreign Exchange Management (Overseas Investment) Rules, 2022 and the Foreign Exchange Management (Overseas Investment) Regulations, 2022 ("**FEMA**"). Any payment for the shares purchased on exercise, and any tax required to be withheld by law, will only be made by the payment methods prescribed under Section 5(f)(1) of the Plan in accordance with the Foreign Exchange Management (Overseas Investment) Rules, 2022 read with the Liberalised Remittance Scheme. Further, a cashless exercise method (whereby unless otherwise determined by the Company at the time of exercise, Participant must immediately sell all shares of Common Stock purchased on exercise in order to facilitate the required repatriation of proceeds in connection with shares of Common Stock issued on exercise of the option, with the required amount of the sale proceeds being delivered to the Company) can only be exercised if the acquisition of Common Stock by Participant falls under the Overseas

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Portfolio Investment ("**OPI**")<sup>1</sup> route in accordance with FEMA. The Company reserves the right to prescribe an alternative method of payment that Participant shall use (whether set out in the Agreement and/or the Plan or otherwise) and / or of settling the option other than by issuance of Common Stock depending on the development of local law. This paragraph applies notwithstanding any contrary provision in the Agreement or the Plan.

**Exchange Control Information**. Participant acknowledges that at the time of exercise Participant's acquisition of the Common Stock may be categorized as either OPI or Overseas Direct Investment ("**ODI**")<sup>2</sup> in accordance with FEMA. In case the acquisition is classified as ODI, certain additional investment related restrictions as set out under FEMA may be applicable and further Participant would be required to submit the specified form ("**Form FC***"*) with Participant's authorized dealer bank and provide the necessary details, documents, and declarations, including, if required, submitting to Participant's authorized dealer bank, share certificates or any other relevant documents as an evidence of such investment in the foreign entity within six months from the date of effecting remittance.

On sale of the shares purchased under the Plan or the receipt of any dividends on the Common Stock, Participant acknowledges Participant's obligation and agrees to obtain a foreign inward remittance certificate ("**FIRC**") from the bank in which Participant deposits the foreign currency and maintains the FIRC as evidence of the repatriation of funds in the event the Reserve Bank of India or the Company requests proof of repatriation. Further in case the acquisition of the Common Stock was under the ODI route, Participant would be required to (i) repatriate any proceeds from the sale of shares of Common Stock or the receipt of any dividends to India within 90 days of the date of sale or the date of the dividends falling due (as maybe applicable), and (ii) submit Form FC with Participant's authorized dealer bank and provide the necessary details, documents, and declarations therein within the prescribed timeline. In case the acquisition of the Common Stock was under the OPI route, Participant would be required to repatriate any proceeds from the sale of shares of Common Stock or the receipt of any dividends to India within 180 days of the date of sale or the date of the dividends falling due (as maybe applicable), unless such proceeds are reinvested in compliance with FEMA.

It is Participant's responsibility to comply with all of these requirements. The Company will not be liable for any fines or penalties resulting from Participant's failure to comply with any applicable laws.

**Tax.** By accepting the terms of the Notice of Grant, the Agreement and the Plan, Participant acknowledges and agrees to comply with all applicable Indian laws and report any income and pay any and all applicable taxes, as required by Indian laws, associated with the shares of Common Stock, the sale of shares of Common Stock acquired under the Plan, and the receipt of any dividends paid on such shares of Common Stock. Participant will co-operate with the board of directors of the Company and any affiliate who is Participant's employer, to ensure that the Company and such affiliate are at all times compliant with all applicable laws. Without prejudice

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<sup>1</sup> Acquisition of securities of up to 10 per cent. of the paid-up equity capital (without control) in a foreign listed entity will qualify as an OPI.

<sup>2</sup> Any: (i) acquisition of securities in an unlisted foreign entity; or (ii) an acquisition of securities of more than 10 per cent. or control in a listed foreign entity, will qualify as an ODI.

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to the aforesaid, Participant will forthwith provide all necessary information upon request by such affiliate in order for the affiliate to make necessary filings with the regulatory authorities as required under applicable law. Where necessary and so directed by the affiliate, Participant will make such payments or deposit such amounts with the affiliate so as to enable the affiliate to comply with its tax obligations under applicable laws. Participant acknowledges and confirms that the entitlement to the shares of Common Stock is contingent upon Participant complying with Participant's obligations herein, the Agreement and the Plan.

**Data Privacy.** Section 10(b) (Data Privacy) of the Agreement is deleted and replaced with the following:

"10(b). Participant explicitly and unambiguously consents to the collection, use, disclosure and transfer, in electronic or other form, of Participant's personal information (as such term is defined in the Information Technology Act, 2000 read with the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules, 2011) as described in this document by and among, as applicable, Participant's employer, the Company and its affiliates for the exclusive purpose of implementing, administering and managing Participant's participation in the Plan. Participant understands that the Company, its affiliates and Participant's employer hold certain personal information about Participant, including, but not limited to, name, home address and telephone number, date of birth, social security number (or other identification number), salary, nationality, job title, any shares of stock or directorships held in the Company and/or any affiliate, details of all options or any other entitlement to shares of stock awarded, canceled, purchased, exercised, vested, unvested or outstanding in Participant's favor for the purpose of implementing, managing and administering the Plan ("***Data***"). Participant understands and consents that the Data may be transferred to any third parties assisting in the implementation, administration and management of the Plan, that these recipients may be located in Participant's country or elsewhere, and that the recipient country may have different data privacy laws providing less protections of Participant's personal data than Participant's country. Participant may request a list with the names and addresses of any potential recipients of the Data by contacting the Company. Participant authorizes the recipients to receive, possess, process, use, retain and transfer the Data, in electronic or other form, for the purposes of implementing, administering and managing Participant's participation in the Plan, including any requisite transfer of such Data, as may be required to a broker or other third party with whom Participant may elect to deposit any shares of Common Stock acquired upon the vesting of the options. Participant understands that Data will be held only as long as is necessary to implement, administer and manage Participant's participation in the Plan. Participant may, at any time, view the Data, request additional information about the storage and processing of the Data, require any necessary amendments to the Data or refuse or withdraw the consents herein, in any case without cost, by contacting the Company in writing. Participant understands that refusing or withdrawing consent may affect Participant's ability to participate in the Plan."

**General**. Further, the Plan and the corresponding documents have neither been delivered for registration nor are they intended to be registered with any regulatory authorities in India. These

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documents are not intended for distribution and are meant solely for the consideration of the person to whom they are addressed and should not be reproduced by Participant.

**United Kingdom**

**Option not a Service Contract**. The following supplements Section 8 of the Agreement:

"the Participant waives all rights to compensation or damages in consequence of the termination of the Participant's office or employment with the Company or any affiliate for any reason whatsoever (whether lawful or unlawful and including, without prejudice to the foregoing, in circumstances giving rise to a claim for wrongful dismissal) in so far as those rights arise or may arise from the Participant ceasing to hold or being able to vest the Participant's option, or from the loss or diminution in value of any rights or entitlements in connection with the Plan."

**Withholding Obligations**. The following supplements Section 6(a) of the Agreement:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) As a condition of the vesting of the Participant's option, the Participant unconditionally and irrevocably agrees:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) to place the Company in funds and indemnify the Company in respect of (1) all liability to UK income tax which the Company is liable to account for on the Participant's behalf directly to HM Revenue & Customs; (2) all liability to national insurance contributions which the Company is liable to account for on the Participant's behalf to HM Revenue & Customs (including, to the extent permitted by law, secondary class 1 (employer's) national insurance contributions for which the Participant is liable and hereby agree to bear); and (3) all liability to national insurance contributions for which the Company is liable and which is formally transferred to the Participant, which arises as a consequence of or in connection with the exercise of the Participant's option (the "***UK Tax Liability***"); or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) to permit the Company to sell at the best price which it can reasonably obtain such number of shares of Common Stock allocated or allotted to the Participant following exercise as will provide the Company with an amount equal to the UK Tax Liability; and to permit the Company to withhold an amount not exceeding the UK Tax Liability from any payment made to the Participant (including, but not limited to salary); and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii) if so required by the Company, and, to the extent permitted by law, to enter into a joint election or other arrangements under which the liability for all or part of such employer's national insurance contributions liability is transferred to the Participant; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv) if so required by the Company, to enter into a joint election within Section 431 of (UK) Income Tax (Earnings and Pensions) Act 2003 ("***ITEPA***") in respect of computing any tax charge on the acquisition of "restricted securities" (as defined in Section 423 and 424 of ITEPA); and

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(v) to sign, promptly, all documents required by the Company to effect the terms of this provision, and references in this provision to "the Company" shall, if applicable, be construed as also referring to any affiliate (or the Participant's employer, if different).

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**Exhibit B**

**Notice of Stock Option Exercise – Non-U.S.**

[DATE]<sup>1</sup>

Faeth Therapeutics, Inc.

[Address]

[Address]

Attention: Treasurer

Dear Sir or Madam:

I am the holder of a Nonstatutory Stock Option granted to me under the Faeth Therapeutics, Inc. (the "**Company**") 2019 Stock Incentive Plan on [________]<sup>2</sup> for the purchase of [________]<sup>3</sup> shares of Common Stock of the Company at a purchase price of US$[________]<sup>4</sup> per share.

I hereby exercise my option to purchase [________]<sup>5</sup> shares of Common Stock (the "**Shares**"), for which I have enclosed [________]<sup>6</sup> in the amount of [________]<sup>7</sup>. Please register my stock certificate as follows:

Name(s): <sup>8</sup> Address:

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<sup>1</sup> Enter date of exercise.

<sup>2</sup> Enter the date of grant.

<sup>3</sup> Enter the total number of shares of Common Stock for which the option was granted.

<sup>4</sup> Enter the option exercise price per share of Common Stock.

<sup>5</sup> Enter the number of shares of Common Stock to be purchased upon exercise of all or part of the option.

<sup>6</sup> Enter "cash", "personal check" or if permitted by the option or Plan, "stock certificates No. XXXX and XXXX".

<sup>7</sup> Enter the dollar amount (price per share of Common Stock times the number of shares of Common Stock to be purchased), or the number of shares tendered. Fair market value of shares tendered, together with cash or check, must cover the purchase price of the shares issued upon exercise.

<sup>8</sup> Enter name(s) to appear on stock certificate in one of the following formats: (a) your name only (i.e., John Doe); (b) your name and other name (i.e., John Doe and Jane Doe, Joint Tenants with Right to Survivorship); or for Nonstatutory Stock Options only, (c) a child's name, with you as custodian (i.e. Jane Doe, Custodian for Tommy Doe). Note: There may be income and/or gift tax consequences for registering shares in a child's name.

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I represent, warrant and covenant as follows:

1. I am purchasing the Shares for my own account for investment only, and not with a view to, or for sale in connection with, any distribution of the Shares in violation of the Securities Act of 1933 (the "**Securities Act**"), or any rule or regulation under the Securities Act.

2. I have had such opportunity as I have deemed adequate to obtain from representatives of the Company such information as is necessary to permit me to evaluate the merits and risks of my investment in the Company.

3. I have sufficient experience in business, financial and investment matters to be able to evaluate the risks involved in the purchase of the Shares and to make an informed investment decision with respect to such purchase.

4. I can afford a complete loss of the value of the Shares and am able to bear the economic risk of holding such Shares for an indefinite period.

5. I understand that (i) the Shares have not been registered under the Securities Act and are "restricted securities" within the meaning of Rule 144 under the Securities Act, (ii) the Shares cannot be sold, transferred or otherwise disposed of unless they are subsequently registered under the Securities Act or an exemption from registration is then available; (iii) in any event, the exemption from registration under Rule 144 will not be available for at least six months and even then will not be available unless a public market then exists for the Common Stock, adequate information concerning the Company is then available to the public, and other terms and conditions of Rule 144 are complied with; and (iv) there is now no registration statement on file with the Securities and Exchange Commission with respect to any stock of the Company and the Company has no obligation or current intention to register the Shares under the Securities Act.

[By the execution and delivery of this Notice of Stock Option Exercise, I shall be, and hereby agree to be, bound by the (i) [Amended and Restated] Voting Agreement, dated [__________], by and among the Company and the other signatories thereto (the "**Voting Agreement**"), as a ["Key Holder" and "Stockholder"] (each as defined in the Voting Agreement) for all purposes under the Voting Agreement and (ii) [Amended and Restated] Right of First Refusal and Co-Sale Agreement, dated [__________], by and among the Company and the other signatories thereto (the "**ROFR and Co-Sale Agreement**"), as a ["Key Holder"] (as defined in the ROFR and Co- Sale Agreement) for all purposes under the ROFR and Co-Sale Agreement. In addition to the foregoing, I shall execute and deliver to the Company (i) an [Adoption Agreement] in the form attached to the Voting Agreement, thereby agreeing to be bound by and subject to the terms of the Voting Agreement as a ["Key Holder" and "Stockholder"] (each as defined in the Voting Agreement) and (ii) a [counterpart signature page] to the ROFR and Co-Sale Agreement, thereby agreeing to be bound by and subject to the terms of the ROFR and Co-Sale Agreement as a ["Key Holder"] (as defined in the ROFR and Co-Sale Agreement). I acknowledge and agree that

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I have received a copy of the Voting Agreement and the Right of First Refusal and Co-Sale Agreement.]<sup>1</sup>

Very truly yours,

[Name]

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<sup>1</sup> This provision should be included if the Company is party to a Voting Agreement and/or Right of First Refusal and Co-Sale Agreement and pursuant to the terms of such Voting Agreement and/or Right of First Refusal and Co- Sale Agreement, the Participant is required to be a party to, and be bound by, the Voting Agreement and/or Right of First Refusal and Co-Sale Agreement. The defined terms in this section should be revised to correspond to the defined terms in the Voting Agreement or Right of First Refusal and Co-Sale Agreement (as applicable). In addition, the Participant should receive a copy of the Voting Agreement and/or Right of First Refusal and Co-Sale Agreement and also execute and deliver the Adoption Agreement (or similar agreement) pursuant to the terms of the Voting Agreement and a counterpart signature page to the Right of First Refusal and Co-Sale Agreement.

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**Exhibit C**

**Faeth Therapeutics, Inc. 2019 Stock Incentive Plan**

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**Joint Election under s431 ITEPA 2003 for full or partial disapplication of Chapter 2 Income Tax**

**(Earnings and Pensions) Act 2003**<sup>1</sup>

**One Part Election**

**1. Between**

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| | |
|:---|:---|
| &nbsp;&nbsp;the Employee | &nbsp;&nbsp;*[NAME]* |
| &nbsp;&nbsp;whose National Insurance Number is | &nbsp;&nbsp;*[**]* |
| &nbsp;&nbsp;and |  |
| &nbsp;&nbsp;the Company (who is the Employee's employer)<sup>2</sup> | &nbsp;&nbsp;*[NAME]* |
| &nbsp;&nbsp;of Company Registration Number | &nbsp;&nbsp;*[**]* |

---

**2. Purpose of Election**

This joint election is made pursuant to section 431(1) or 431(2) Income Tax (Earnings and Pensions) Act 2003 (ITEPA) and applies where employment-related securities, which are restricted securities by reason of section 423 ITEPA, are acquired.

The effect of an election under section 431(1) is that, for the relevant Income Tax and NIC purposes, the employment-related securities and their market value will be treated as if they were not restricted securities and that sections 425 to 430 ITEPA do not apply. An election under section 431(2) will ignore one or more of the restrictions in computing the charge on acquisition. Additional Income Tax will be payable (with PAYE and NIC where the securities are Readily Convertible Assets).

**Should the value of the securities fall following the acquisition, it is possible that Income Tax/NIC that would have arisen because of any future chargeable event (in the absence of an election) would have been less than the Income Tax/NIC due by reason of this election. Should this be the case, there is no Income Tax/NIC relief available under Part 7 of ITEPA 2003; nor is it available if the securities acquired are subsequently transferred, forfeited or revert to the original owner.**

**3. Application**

This joint election is made not later than 14 days after the date of acquisition of the securities by the employee and applies to:

Number of securities *[**]* <br> Description of securities Shares of Common Stock

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<sup>1</sup> Note to draft: Relevant for UK employees only.

<sup>2</sup> Note to draft: This form to be entered into between the individual and his/her employer (which may not be the issuer of the securities)

------

Name of issuer of securities *Faeth Therapeutics, Inc.* <br> \* acquired by the Employee on [DATE]

\* to be acquired by the Employee between [*dd/mm/yyyy*] and [*dd/mm/yyyy*]

\* to be acquired by the Employee after [*dd/mm/yyyy*] under the terms of [insert scheme/plan name]

*(\* delete as appropriate)*

**4. Extent of Application**

This election disapplies (\* delete as appropriate):

\* S.431(1) ITEPA: All restrictions attaching to the securities, or

\* S431(2) ITEPA: The following specified restriction : [details of specified restriction]

**5. Declaration**

This election will become irrevocable upon the later of its signing or the acquisition (\* and each subsequent acquisition) of employment-related securities to which this election applies.

*(\* delete as appropriate)*

In signing this joint election, we agree to be bound by its terms as stated above.

---

| | |
|:---|:---|
| &nbsp;&nbsp; <br>Signature (Employee)<br>| &nbsp;&nbsp; / / |
| &nbsp;&nbsp; <br>Signature (for and on behalf of the Company)<sup>1</sup><br>| &nbsp;&nbsp; / / |
| &nbsp;&nbsp; <br>Position in company |  |

---

Note: Where the election is in respect of multiple acquisitions, prior to the date of any subsequent acquisition of a security it may be revoked by agreement between the employee and employer in respect of that and any later acquisition.

------

<sup>1</sup> Note to draft: This form to be entered into between the individual and his/her employer (which may not be the issuer of the securities)

------

## Exhibit 10.10

Exhibit 10.10

# AMENDED AND RESTATED EMPLOYMENT AGREEMENT
This **AMENDED AND RESTATED EMPLOYMENT AGREEMENT** (the

"***Agreement***"), is entered into effective as of July 31, 2024 (the "***Effective Date***"), by and between Sensei Biotherapeutics, Inc. (the "***Company***") and Christopher Gerry (the "***Executive***"). This Agreement amends, restates, and supersedes in its entirety the Employment Agreement between the Company and Executive, dated July 18, 2022 (the "***Prior Agreement***").

The Company desires to continue to employ Executive, now in the capacity of full-time SVP, General Counsel, pursuant to the terms of this Agreement and, in connection therewith, to compensate Executive for Executive's personal services to the Company; and

Executive wishes to continue to be employed by the Company and provide personal services to the Company in return for certain compensation.

Accordingly, in consideration of the mutual promises and covenants contained herein, the parties agree to the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.** **<u>EMPLOYMENT BY THE COMPANY</u>.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.1** **<u>At-Will Employment</u>**. Executive shall be employed by the Company on an "at-will" basis, meaning either the Company or Executive may terminate Executive's employment at any time, with or without cause or advanced notice. Any contrary representations that may have been made to Executive shall be superseded by this Agreement. This Agreement shall constitute the full and complete agreement between Executive and the Company on the "at-will" nature of Executive's employment with the Company, which may be changed only in an express written agreement signed by Executive and a duly authorized officer of the Company. Executive's rights to any compensation following a termination shall be only as set forth in Section 6.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.2** **<u>Position</u>**. Subject to the terms set forth herein, the Company agrees to continue to employ Executive in the position of SVP, General Counsel, and Executive hereby accepts such continued employment. During the term of Executive's employment with the Company, Executive will devote Executive's best efforts and substantially all of Executive's business time and attention to the business of the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.3** **<u>Duties</u>**. Executive will report to the President and Chief Executive Officer ("***CEO****")* performing such duties as are normally associated with Executive's then-current position and such duties as are assigned to Executive from time to time, subject to the oversight and direction of the CEO. In general, and without limitation, Executive will: serve as a senior leader in the organization and be responsible for all legal and compliance affairs of the Company, serve as corporate secretary, and oversee contract management. Executive shall perform Executive's duties under this Agreement principally out of the Company's office in the Boston, Massachusetts area or such other location as assigned. In addition, Executive shall make such business trips to such places as may be necessary or advisable for the efficient operations of the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.4** **<u>Company Policies and Benefits</u>**. The employment relationship between the parties shall also be subject to the Company's personnel policies and procedures as they may

be interpreted, adopted, revised or deleted from time to time in the Company's sole discretion. Executive will be eligible to participate on the same basis as similarly situated employees in the Company's benefit plans in effect from time to time during Executive's employment. All matters of eligibility for coverage or benefits under any benefit plan shall be determined in accordance with the provisions of such plan. The Company reserves the right to change, alter, or terminate any

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Exhibit 10.10

benefit plan in its sole discretion. Notwithstanding the foregoing, in the event that the terms of this Agreement differ from or are in conflict with the Company's general employment policies or practices, this Agreement shall control.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.5** **<u>Insurance</u>**. While this Agreement is in effect, for actions within the scope of Executive's employment, the Company will include Executive as an insured at a level comparable to other officers of the Company in its Directors and Officers Liability insurance policy in effect from time to time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.** **<u>COMPENSATION</u>.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.1** **<u>Salary</u>**. Executive shall receive for Executive's services to be rendered hereunder an initial annualized base salary of $385,000, subject to review and adjustment from time to time by the Company in its sole discretion ("***Base Salary***"). The Base Salary is payable subject to standard federal and state payroll withholding requirements in accordance with the Company's standard payroll practices.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.2** **<u>Annual Bonus</u>**. Executive shall be eligible to receive an annual performance bonus of up to 35% (the "***Target Percentage***") of Executive's then-current Base Salary ("***Annual Bonus***"). The Annual Bonus will be based upon the Company's assessment of Executive's performance, the Company's attainment of targeted goals as set by the Company's Board of Directors (the "***Board***") in its sole discretion, overall economic conditions and forecasts, and related financial factors, all as determined by the Company in its sole discretion. The Annual Bonus, if any, will be subject to applicable payroll deductions and withholdings. Following the close of each calendar year, the Company will determine whether Executive has earned the Annual Bonus, and the amount of any Annual Bonus (which can be less than the Target Percentage), based on the set criteria. No amount of the Annual Bonus is guaranteed, and Executive must be an employee in good standing on the Annual Bonus payment date to be eligible to receive an Annual Bonus; no partial or prorated bonuses will be provided. Executive's eligibility for an Annual Bonus is subject to change in the discretion of the Board (or any authorized committee thereof).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.3** **<u>Future Equity Awards</u><u>.</u>** Executive remains eligible to be considered for future equity awards as may be determined by the Board or a committee of the Board in its discretion in accordance with the terms of any applicable equity plan or arrangement that may be in effect from time to time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.4** **<u>Expense Reimbursement</u>**. The Company will reimburse Executive for all reasonable, documented business expenses incurred in connection with Executive's services hereunder, in accordance with the Company's business expense reimbursement policies and procedures as may be in effect from time to time. For the avoidance of doubt, to the extent that any reimbursements payable to Executive are subject to the provisions of Section 409A (as defined below): (i) any such reimbursements will be paid no later than December 31 of the year following the year in which the expense was incurred, (ii) the amount of expenses reimbursed in one year will not affect the amount eligible for reimbursement in any subsequent year, and (iii) the right to

reimbursement under this Agreement will not be subject to liquidation or exchange for another benefit.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.** **<u>CONFIDENTIAL INFORMATION, INVENTION ASSIGNMENT, NON-SOLICITATION, AND NON-COMPETITION OBLIGATIONS</u>**. As a condition of

------

Exhibit 10.10

continued employment and in consideration of the benefits that Executive is eligible to receive under this Agreement, including, but not limited to, the compensation offered and provided to Executive hereunder, and as an express condition of the offer and provision of such additional compensation to Executive, Executive agrees to continue to abide by that certain Confidential Information, Invention Assignment, Non-Solicitation and Non-Competition Agreement (the "***Covenants Agreement***") previously entered into between the Company and Executive and made effective as of July 18, 2022.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.** **<u>OUTSIDE ACTIVITIES</u>**. Except with the prior written consent of the Board, Executive will not, while employed by the Company, undertake or engage in any other employment, occupation or business enterprise that would interfere with Executive's responsibilities and the performance of Executive's duties hereunder except for (i) reasonable time devoted to volunteer services for or on behalf of such religious, educational, non-profit and/or other charitable organization as Executive may wish to serve; (ii) reasonable time devoted to activities in the non-profit and business communities consistent with Executive's duties; (iii) Executive's participation in professional and academic activities; and (iv) such other activities as may be specifically approved by the Board. This restriction shall not, however, preclude Executive from managing personal investments or owning less than one percent (1%) of the total outstanding shares of a publicly-traded company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.** **<u>NO CONFLICT WITH EXISTING OBLIGATIONS</u>**. Executive represents that Executive's performance of all the terms of this Agreement and as an employee of the Company do not and will not breach any agreement or obligation of any kind made prior to Executive's employment by the Company, including agreements or obligations Executive may have with prior employers or entities for which Executive has provided services. Executive has not entered into, and Executive agrees that Executive will not enter into, any agreement or obligation, either written or oral, in conflict herewith.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.** **<u>TERMINATION OF EMPLOYMENT</u>**. The parties acknowledge that Executive's employment relationship with the Company shall be at-will. Either Executive or the Company may terminate the employment relationship at any time, with or without "Cause" (as defined in Section 6.3(a) below). The provisions in this Section govern the amount of compensation, if any, to be provided to Executive upon termination of employment and do not alter this at-will status.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.1** **<u>Termination by the Company Without Cause or Resignation by</u> <u>Executive for Good Reason (not in Connection with a Change in Control)</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)**The Company shall have the right to terminate Executive's employment with the Company pursuant to this Section 6.1 at any time without Cause by giving notice as described in Section 6.7 of this Agreement. A termination pursuant to Section 6.5 or 6.6 below is not a termination without "Cause" for purposes of receiving the Non-CIC Severance Benefits described in (and as defined in) this Section 6.1 or the CIC Severance Benefits described in (and as defined in) Section 6.2.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)**If the Company terminates Executive's employment at any time without Cause or Executive terminates Executive's employment with the Company for "Good Reason" (as defined in Section 6.1(g) below), in either case, at any time except during the Change in Control Measurement Period (both "Change in Control" and "Change in Control Measurement Period" as defined in Section 6.2 below), then Executive shall be entitled to receive the Accrued Obligations (defined in 6.1(d) below). If such termination without Cause or for Good Reason not occurring during the Change in Control Measurement Period constitutes a "separation from

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Exhibit 10.10

service" (as defined under Treasury Regulation Section 1.409A-1(h), without regard to any alternative definition thereunder, a "***Separation from Service***"), and Executive complies with the obligations in Section 6.1(c) below, Executive shall also be eligible to receive the following "***Non-CIC Severance Benefits***:"

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(i)**The Company will pay Executive an amount equal to Executive's then current Base Salary for six (6) months, less all applicable withholdings and deductions, paid in equal installments beginning on the Company's first regularly scheduled payroll date following the Release Effective Date (as defined in Section 6.1(c) below), with the remaining installments occurring on the Company's regularly scheduled payroll dates thereafter; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(ii)**Provided Executive or Executive's covered dependents, as the case may be, timely elects continued coverage under COBRA, or state continuation coverage (as applicable), under the Company's group health plans following such termination, the Company will pay the portion of the COBRA, or state continuation coverage, premiums which is equal to the cost of the coverage that the Company was paying as of the date of termination, to continue Executive's (and Executive's covered dependents, as applicable) health insurance coverage in effect on the termination date until the earliest of: (1) six (6) months following the termination date; (2) the date when Executive becomes eligible for substantially equivalent health insurance coverage in connection with new employment or self-employment; or (3) the date Executive ceases to be eligible for COBRA or state law continuation coverage for any reason, including plan termination (such period from the termination date through the earlier of (1)-(3), (the "***Non-CIC COBRA Payment Period***")). Notwithstanding the foregoing, if at any time the Company determines that its payment of COBRA, or state continuation coverage, premiums on Executive's behalf would result in a violation of applicable law (including, but not limited to, the 2010 Patient Protection and Affordable Care Act, as amended by the 2010 Health Care and Education Reconciliation Act), then in lieu of paying such premiums pursuant to this Section, the Company shall pay Executive on the last day of each remaining month of the Non-CIC COBRA Payment Period, a fully taxable cash payment equal to the COBRA or state continuation coverage premium for such month, subject to applicable tax withholding, for the remainder of the Non-CIC COBRA Payment Period. Nothing in this Agreement shall deprive Executive of Executive's rights under COBRA or ERISA for benefits under plans and policies arising under Executive's employment by the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c)**Executive will be paid all of the Accrued Obligations on the Company's first payroll date after Executive's date of termination from employment or earlier if required by law. Executive shall receive the Non-CIC Severance Benefits pursuant to Section 6.1(b) or the CIC Severance Benefits pursuant to Section 6.2(a) of this Agreement if: (i) by the sixtieth (60<sup>th</sup>) day following the date of Executive's Separation from Service, Executive has signed and delivered to the Company a separation agreement containing an effective, general release of claims in favor of the Company and its affiliates and representatives, in the form presented by the Company (the "***Release***"), which will include a non-competition clause, which cannot be revoked in whole or part by such date (the date that the Release can no longer be revoked is referred to as the "***Release Effective Date***"); and (ii) if Executive holds any other positions with the Company or any Affiliate, including a position on the Board, Executive resigns such position(s) to be effective no later than the date of Executive's termination date (or such other date as requested by the Board); (iii) Executive returns all Company property; (iv) Executive complies with all post-termination obligations under this Agreement and the Covenants Agreement; and (v) Executive complies with the terms of the Release, including without limitation any non-disparagement and confidentiality provisions contained in the Release.

------

Exhibit 10.10

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(d)**For purposes of this Agreement, "***Accrued Obligations***" are (i) Executive's accrued but unpaid salary and accrued but unused vacation days, each through the date of termination, (ii) any unreimbursed business expenses incurred by Executive payable in accordance with the Company's standard expense reimbursement policies, and (iii) benefits owed to Executive under any qualified retirement plan or health and welfare benefit plan in which Executive was a participant in accordance with applicable law and the provisions of such plan.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(e)**The Non-CIC Severance Benefits provided to Executive pursuant to this Section 6.1 are in lieu of, and not in addition to, any benefits to which Executive may otherwise be entitled under any Company severance plan, policy, program, or prior agreement with the Company. For avoidance of doubt, Executive shall not be eligible for both CIC Severance Benefits and Non-CIC Severance Benefits.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(f)**Any damages caused by the termination of Executive's employment without Cause not in connection with a Change in Control would be difficult to ascertain; therefore, the Non-CIC Severance Benefits for which Executive is eligible pursuant to Section 6.1(b) above in exchange for the Release is agreed to by the parties as liquidated damages, to serve as full compensation, and not a penalty.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(g)**For purposes of this Agreement, "***Good Reason***" shall mean the occurrence of any of the following events without Executive's consent: (i) a material reduction in Executive's Base Salary of at least 10%, other than pursuant to a reduction proportionately affecting all of the Company's other senior level executive employees; (ii) a material reduction in Executive's duties, authority and responsibilities relative to Executive's duties, authority, and responsibilities in effect immediately prior to such reduction; (iii) the relocation of Executive's principal place of employment, without Executive's consent, in a manner that lengthens Executive's one-way commute distance by fifty (50) or more miles from Executive's then-current principal place of employment immediately prior to such relocation; or (iv) any material breach of this Agreement by the Company; *provided, however,* that, any such termination by Executive shall only be deemed for Good Reason pursuant to this definition if: (1) Executive gives the Company written notice of Executive's intent to terminate for Good Reason within thirty (30) days following the first occurrence of the condition(s) that Executive believes constitute(s) Good Reason, which notice shall describe such condition(s); (2) the Company fails to remedy such condition(s) within thirty (30) days following receipt of the written notice (the "***Cure Period***"); (3) the Company has not, prior to receiving such notice from Executive, already informed Executive that Executive's employment with the Company is being terminated; and (4) Executive voluntarily terminates Executive's employment within thirty (30) days following the end of the Cure Period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.2** **<u>Termination by the Company without Cause or Resignation by</u> <u>Executive for Good Reason (in connection with a Change in Control)</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)**In the event that Executive's employment is terminated without Cause or Executive resigns for Good Reason within twelve (12) months following the effective date of a Change in Control ("***Change in Control Measurement Period***") of the Company, then Executive shall be entitled to the Accrued Obligations and, subject to Executive's full compliance with Section 6.1(c) above, including but not limited to the Release requirement and Executive's continued compliance with obligations to the Company under Executive's Covenants Agreement, then Executive will be eligible for the following "***CIC Severance Benefits***:"

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(i)**The Company will pay Executive an amount equal to Executive's then current Base Salary for twelve (12) months, less all applicable withholdings and deductions, paid in equal installments beginning on the Company's first regularly scheduled payroll date following the Release Effective Date, with the remaining installments occurring on

------

Exhibit 10.10

the Company's regularly scheduled payroll dates thereafter;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(ii)**Provided Executive or Executive's covered dependents, as the case may be, timely elects continued coverage under COBRA, or state continuation coverage (as applicable), under the Company's group health plans following such termination, the Company will pay the portion of the COBRA, or state continuation coverage, premiums which is equal to the cost of the coverage that the Company was paying as of the date of termination, to continue Executive's (and Executive's covered dependents, as applicable) health insurance coverage in effect on the termination date until the earliest of: (1) twelve (12) months following the termination date; (2) the date when Executive becomes eligible for substantially equivalent health insurance coverage in connection with new employment or self-employment; or (3) the date Executive ceases to be eligible for COBRA or state law continuation coverage for any reason, including plan termination (such period from the termination date through the earlier of (1)-(3), (the "***CIC COBRA Payment Period***")). Notwithstanding the foregoing, if at any time the Company determines that its payment of COBRA, or state continuation coverage, premiums on Executive's behalf would result in a violation of applicable law (including, but not limited to, the 2010 Patient Protection and Affordable Care Act, as amended by the 2010 Health Care and Education Reconciliation Act), then in lieu of paying such premiums pursuant to this Section, the Company shall pay Executive on the last day of each remaining month of the CIC COBRA Payment Period, a fully taxable cash payment equal to the COBRA or state continuation coverage premium for such month, subject to applicable tax withholding, for the remainder of the CIC COBRA Payment Period. Nothing in this Agreement shall deprive Executive of Executive's rights under COBRA or ERISA for benefits under plans and policies arising under Executive's employment by the Company;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(iii)**The Company will make a lump sum cash payment to Executive in an amount equal to one (1) times the Target Percentage for the year in which the termination occurs, subject to standard deductions and withholdings, which will be paid in a lump sum on the sixtieth (60th) day following Executive's date of Separation from Service; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(iv)**Effective as of Executive's termination date, the vesting and exercisability of all outstanding equity awards held by Executive immediately prior to the termination date (if any) shall be accelerated in full.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)**For purposes of this Agreement, a "***Change in Control***" shall have the meaning set forth in the 2021 Plan, as amended from time to time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c)**The CIC Severance Benefits provided to Executive pursuant to this

Section 6.2 are in lieu of, and not in addition to, any benefits to which Executive may otherwise be entitled under any Company severance plan, policy or program.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(d)**Any damages caused by the termination of Executive's employment without Cause during the Change in Control Measurement Period would be difficult to ascertain; therefore, the CIC Severance Benefits for which Executive is eligible pursuant to Section 6.2(a) above in exchange for the Release are agreed to by the parties as liquidated damages, to serve as full compensation, and not a penalty.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.3** **<u>Termination by the Company for Cause</u>**.

Subject to Section 6.3(b) below, the Company shall have the right to terminate Executive's employment with the Company at any time for Cause by giving notice as described in Section 6.7 of this Agreement.

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Exhibit 10.10

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)**"***Cause***" for termination shall mean that the Company has determined in its sole discretion that Executive has engaged in any of the following: (i) a material breach of any covenant or condition under this Agreement or any other agreement between the parties; (ii) any act constituting dishonesty, fraud, immoral or disreputable conduct; (iii) any conduct which constitutes a felony under applicable law; (iv) material violation of any Company policy or any act of misconduct; (v) refusal to follow or implement a clear and reasonable directive of the Company; (vi) negligence or incompetence in the performance of Executive's duties after the expiration of ten (10) days without cure after written notice of such failure; or (vii) breach of fiduciary duty.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)**In the event Executive's employment is terminated at any time for Cause, Executive will not receive the Non-CIC Severance Benefits, the CIC Severance Benefits, or any other severance compensation or benefit, except that, consistent with the Company's standard payroll policies, the Company shall provide to Executive the Accrued Obligations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.4** **<u>Resignation by Executive (other than for Good Reason)</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)**Executive may resign for any reason from Executive's employment with the Company at any time by giving notice as described in Section 6.7.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)**In the event Executive resigns from Executive's employment with the Company (other than for Good Reason), Executive will not receive the Non-CIC Severance Benefits, the CIC Severance Benefits, or any other severance compensation or benefit, except that, consistent with the Company's standard payroll policies, the Company shall provide to Executive the Accrued Obligations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.5** **<u>Termination by Virtue of Death or Disability of Executive</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)**In the event of Executive's death while employed pursuant to this Agreement, all obligations of the parties hereunder shall terminate immediately, and the Company shall, pursuant to the Company's standard payroll policies, provide to Executive's legal representatives Executive's Accrued Obligations, but neither Executive nor Executive's legal representatives will be eligible for the Non-CIC Severance Benefits, the CIC Severance Benefits, or any other severance compensation or benefit.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)**Subject to applicable state and federal law, the Company shall at all

times have the right, upon written notice to the Executive, to terminate this Agreement based on Executive's Disability (as defined below). Termination by the Company of Executive's employment based on "***Disability***" shall mean termination because Executive is unable due to a physical or mental condition to perform the essential functions of Executive's position with or without reasonable accommodation for six (6) months in the aggregate during any twelve (12) month period or based on the written certification by two licensed physicians of the likely continuation of such condition for such period. This definition shall be interpreted and applied consistent with the Americans with Disabilities Act, the Family and Medical Leave Act, and other applicable law. In the event Executive's employment is terminated based on Executive's Disability, Executive will not receive the Non-CIC Severance Benefits, the CIC Severance Benefits, or any other severance compensation or benefit, except that, pursuant to the Company's standard payroll policies, the Company shall provide to Executive the Accrued Obligations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.6** **<u>Termination Due to Discontinuance of Business</u>**. Anything in this Agreement to the contrary notwithstanding, in the event the Company's business is discontinued because rendered impracticable by substantial financial losses, lack of funding, legal decisions,

------

Exhibit 10.10

administrative rulings, declaration of war, dissolution, national or local economic depression or crisis or any reasons beyond the control of the Company, then this Agreement shall terminate as of the day the Company determines to cease operation with the same force and effect as if such day of the month were originally set as the termination date hereof. In the event this Agreement is terminated pursuant to this Section 6.6, Executive will not receive the Non-CIC Severance Benefits, the CIC Severance Benefits, or any other severance compensation or benefit, except that, pursuant to the Company's standard payroll policies, the Company shall provide to Executive the Accrued Obligations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.7** **<u>Notice; Effective Date of Termination</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)**Termination of Executive's employment (the "***Separation Date***") pursuant to this Agreement shall be effective on the earliest of:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(i)**immediately after the Company gives notice to Executive of Executive's termination, with or without Cause, unless pursuant to Section 6.3(b)(vi) in which case ten (10) days after notice if not cured, or unless the Company specifies a later date, in which case, termination shall be effective as of such later date;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(ii)**immediately upon Executive's death;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(iii)**immediately after the Company gives written notice to Executive of Executive's termination on account of Executive's Disability, unless the Company specifies a later Separation Date, in which case, termination shall be effective as of such later Separation Date, *provided* that Executive has not returned to the full-time performance of Executive's duties prior to such date;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(iv)**except as addressed by Section 6.7(a)(v), thirty (30) days (or such shorter period agreed to by the CEO and Executive in writing) after Executive gives written notice to the Company of Executive's resignation for any reason, *provided* that the Company may set a Separation Date at any time between the date of notice and the date of resignation, in which case Executive's resignation shall be effective as of such other date. Executive will receive compensation through any required notice period; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(v)**for a termination for Good Reason, immediately upon Executive's full satisfaction of the requirements of Section 6.1(g).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)**In the event notice of a termination under subsection (a)(i) is given orally, at the other party's request, the party giving notice must provide written confirmation of such notice within five (5) business days of the request in compliance with the requirement of Section 7.1 below. In the event of a termination for Cause or a resignation for Good Reason, written confirmation shall specify the subsection(s) of the definition of Cause or the definition of Good Reason relied on to support the decision to terminate.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.8** **<u>Cooperation With Company After Termination of Employment</u>**. Following termination of Executive's employment for any reason, Executive shall reasonably cooperate with the Company in all matters relating to the winding up of Executive's pending work including, but not limited to, any litigation in which the Company is involved, and the orderly transfer of any such pending work to such other employees as may be designated by the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.9** **<u>Effect of Termination</u>**. Executive agrees that should Executive's employment be terminated for any reason, Executive shall be deemed to have resigned from any and all positions with the Company and its subsidiaries.

------

Exhibit 10.10

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.10** **<u>Application of Section 409A</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)**It is intended that all of the compensation payable under this Agreement, to the greatest extent possible, either complies with the requirements of Section 409A of the Internal Revenue Code of 1986, as amended (the "***Code***") and the regulations and other guidance thereunder and any state law of similar effect (collectively, "***Section 409A***") or satisfies one or more of the exemptions from the application of Section 409A, and this Agreement will be construed in a manner consistent with such intention, incorporating by reference all required definitions and payment terms.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)**No severance payments will be made under this Agreement unless Executive's termination of employment constitutes a Separation from Service. For purposes of Section 409A (including, without limitation, for purposes of Treasury Regulations Section 1.409A-2(b)(2)(iii)), Executive's right to receive any installment payments under this Agreement (whether severance payments or otherwise) shall be treated as a right to receive a series of separate payments and, accordingly, each installment payment hereunder shall at all times be considered a separate and distinct payment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c)**To the extent that any severance payments are deferred compensation under Section 409A, and are not otherwise exempt from the application of Section 409A, then, to the extent required to comply with Section 409A, if the period during which Executive may consider and sign the Release spans two calendar years, the severance payments will not begin until the second calendar year. If the Company determines that the severance benefits provided under this Agreement constitutes "deferred compensation" under Section 409A and if Executive is a "specified employee" of the Company, as such term is defined in Section 409A(a)(2)(B)(i) of the Code at the time of Executive's Separation from Service, then, solely to the extent necessary to avoid the incurrence of the adverse personal tax consequences under Section 409A, the timing of the severance will be delayed as follows: on the earlier to occur of (a) the date that is six months and one day after Executive's Separation from Service, and (b) the date of Executive's death, the Company will: (i) pay to Executive a lump sum amount equal to the sum of the severance benefits that Executive would otherwise have received if the commencement of the payment of the severance benefits had not been delayed pursuant to this Section 6.10(c); and (ii) commence paying the balance of the severance benefits in accordance with the applicable payment schedule set forth in Sections 6.1 and 6.2. No interest shall be due on any amounts deferred pursuant to this Section 6.10(c).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(d)**To the extent required to avoid accelerated taxation and/or tax penalties under Section 409A, amounts reimbursable to Executive under this Agreement shall be paid to Executive on or before the last day of the year following the year in which the expense was incurred and the amount of expenses eligible for reimbursement (and in-kind benefits provided to Executive) during any one year may not effect amounts reimbursable or provided in any subsequent year.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(e)**Notwithstanding the foregoing, the Company makes no representations that the payments and benefits provided under this Agreement comply with Section 409A, and in no event shall the Company be liable for all or any portion of any taxes, penalties, interest, or other expenses that may be incurred by the Executive on account of non- compliance with Section 409A.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.11** **<u>Excise Tax Adjustment</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)**If any payment or benefit Executive will or may receive from the

------

Exhibit 10.10

Company or otherwise (a "***280G Payment***") would (i) constitute a "parachute payment" within the meaning of Section 280G of the Code, and (ii) but for this Section, be subject to the excise tax imposed by Section 4999 of the Code (the "***Excise Tax***"), then any such 280G Payment provided pursuant to this Agreement (a "***Payment***") shall be equal to the Reduced Amount. The "***Reduced Amount***" shall be either (x) the largest portion of the Payment that would result in no portion of the Payment (after reduction) being subject to the Excise Tax, or (y) the largest portion, up to and including the total, of the Payment, whichever amount (i.e., the amount determined by clause (x) or by clause (y)), after taking into account all applicable federal, state, and local employment taxes, income taxes, and the Excise Tax (all computed at the highest applicable marginal rate), results in Executive's receipt, on an after-tax basis, of the greater economic benefit notwithstanding that all or some portion of the Payment may be subject to the Excise Tax. If a reduction in a Payment is required pursuant to the preceding sentence and the Reduced Amount is determined pursuant to clause (x) of the preceding sentence, the reduction shall occur in the manner (the "***Reduction Method***") that results in the greatest economic benefit for Executive. If more than one method of reduction will result in the same economic benefit, the items so reduced will be reduced pro rata (the "***Pro Rata Reduction Method***").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)**Notwithstanding any provision of this Section 6.11 to the contrary, if the Reduction Method or the Pro Rata Reduction Method would result in any portion of the Payment being subject to taxes pursuant to Section 409A that would not otherwise be subject to taxes pursuant to Section 409A, then the Reduction Method and/or the Pro Rata Reduction Method, as the case may be, shall be modified so as to avoid the imposition of taxes pursuant to Section 409A as follows: (A) as a first priority, the modification shall preserve to the greatest extent possible, the greatest economic benefit for Executive as determined on an after-tax basis;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(B) as a second priority, Payments that are contingent on future events (*e.g.*, being terminated without Cause), shall be reduced (or eliminated) before Payments that are not contingent on future

events; and (C) as a third priority, Payments that are "deferred compensation" within the meaning of Section 409A shall be reduced (or eliminated) before Payments that are not deferred compensation within the meaning of Section 409A.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c)**Unless Executive and the Company agree on an alternative accounting firm or law firm, the accounting firm engaged by the Company for general tax compliance purposes as of the day prior to the effective date of the Change in Control transaction shall perform the foregoing calculations. If the accounting firm so engaged by the Company is serving as accountant or auditor for the individual, entity, or group effecting the Change in Control transaction, the Company shall appoint a nationally-recognized accounting or law firm to make the determinations required by this Section 6.11. The Company shall bear all expenses with respect to the determinations by such accounting or law firm required to be made hereunder. The Company shall use commercially reasonable efforts to cause the accounting or law firm engaged to make the determinations hereunder to provide its calculations, together with detailed supporting documentation, to Executive and the Company within fifteen (15) calendar days after the date on which Executive's right to a 280G Payment becomes reasonably likely to occur (if requested at that time by Executive or the Company) or such other time as requested by Executive or the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(d)**If Executive receives a Payment for which the Reduced Amount was determined pursuant to clause (x) of Section 6.11(a) and the Internal Revenue Service determines thereafter that some portion of the Payment is subject to the Excise Tax, Executive agrees to promptly return to the Company a sufficient amount of the Payment (after reduction pursuant to clause (x) of Section 6.11(a)) so that no portion of the remaining Payment is subject to the Excise Tax. For the avoidance of doubt, if the Reduced Amount was determined pursuant to clause (y) of

------

Exhibit 10.10

Section 6.11(a), Executive shall have no obligation to return any portion of the Payment pursuant to the preceding sentence.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.** **<u>GENERAL PROVISIONS</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.1** **<u>Notices</u>**. Any notices required hereunder to be in writing shall be deemed effectively given: (a) upon personal delivery to the party to be notified, (b) when sent by electronic mail if sent during normal business hours of the recipient, and if not, then on the next business day, (c) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one (1) day after deposit with a nationally-recognized overnight courier, specifying next-day delivery, with written verification of receipt. All communications shall be sent to the Company at its primary office location and to Executive at Executive's address as listed on the Company payroll or Executive's Company-provided email address, or at such other address as the Company or Executive may designate by ten (10) days' advance written notice to the other.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.2** **<u>Severability</u>**. Whenever possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement is held to be invalid, illegal or unenforceable in any respect under any applicable law or rule in any jurisdiction, such invalidity, illegality or unenforceability will not affect any other provision or any other jurisdiction, but this Agreement will be reformed, construed and enforced in such jurisdiction as if such invalid, illegal or unenforceable provisions had never been contained herein.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.3** **<u>Waiver</u>**. If either party should waive any breach of any provisions of this Agreement, such party shall not thereby be deemed to have waived any preceding or succeeding breach of the same or any other provision of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.4** **<u>Complete Agreement</u>**. This Agreement, and the Covenants Agreements, constitute the entire agreement between Executive and the Company with regard to the subject matter hereof. This Agreement is the complete, final, and exclusive embodiment of their agreement with regard to this subject matter and supersedes any prior oral discussions or written communications and agreements, including the Prior Agreement. This Agreement is entered into without reliance on any promise or representation other than those expressly contained herein, and it cannot be modified or amended except in writing signed by Executive and an authorized officer of the Company. The parties have entered into or are entering into a separate Covenants Agreement in connection herewith and have or may enter into separate agreements related to equity awards. These separate agreements govern other aspects of the relationship between the parties, have or may have provisions that survive termination of Executive's employment under this Agreement, may be amended or superseded by the parties without regard to this Agreement and are enforceable according to their terms without regard to the enforcement provision of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.5** **<u>Counterparts</u>**. This Agreement may be executed in separate counterparts, any one of which need not contain signatures of more than one party, but all of which taken together will constitute one and the same agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.6** **<u>Headings</u>**. The headings of the sections hereof are inserted for convenience only and shall not be deemed to constitute a part hereof nor to affect the meaning thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.7** **<u>Successors and Assigns</u>**. The Company shall assign this Agreement and its rights and obligations hereunder in whole, but not in part, to any Company or other entity with or into which the Company may hereafter merge or consolidate or to which the Company may transfer all or substantially all of its assets, if in any such case said Company or other entity shall by operation of law or expressly in writing assume all obligations of the Company hereunder as fully

------

Exhibit 10.10

as if it had been originally made a party hereto, but may not otherwise assign this Agreement or its rights and obligations hereunder. Executive may not assign or transfer this Agreement or any rights or obligations hereunder, other than to Executive's estate upon Executive's death.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.8** **<u>Choice of Law</u>**. All questions concerning the construction, validity and interpretation of this Agreement will be governed by the law of the Commonwealth of Massachusetts.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.9** **<u>Resolution of Disputes</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)**To ensure the timely and economical resolution of disputes that may arise in connection with Executive's employment with the Company, Executive and the Company agree that any and all disputes, claims, or causes of action arising from or relating to the enforcement, breach, performance, negotiation, execution, or interpretation of this Agreement or Executive's employment, or the termination of Executive's employment, including but not limited to all statutory claims, will be resolved pursuant to the Federal Arbitration Act, 9 U.S.C. §1-16, and to the fullest extent permitted by law, by final, binding and confidential arbitration by a single arbitrator conducted in ***Boston, Massachusetts*** by Judicial Arbitration and Mediation Services Inc. ("***JAMS***") under the then applicable JAMS rules (at the following web address: <u>https://</u>www.jamsadr.com/rules-employment-arbitration/); provided, however, this arbitration provision shall not apply to sexual harassment claims to the extent prohibited by applicable law. A hard copy of the rules will be provided to Executive upon request.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** **By agreeing to this arbitration procedure, both Executive and the Company waive the right to resolve any such dispute through a trial by jury or judge or administrative proceeding**. In addition, all claims, disputes, or causes of action under this Section, whether by Executive or the Company, must be brought in an individual capacity, and shall not be brought as a plaintiff (or claimant) or class member in any purported class or representative proceeding, nor joined or consolidated with the claims of any other person or entity. The arbitrator may not consolidate the claims of more than one person or entity, and may not preside over any form of representative or class proceeding. To the extent that the preceding sentences regarding class claims or proceedings are found to violate applicable law or are otherwise found unenforceable, any claim(s) alleged or brought on behalf of a class shall proceed in a court of law rather than by arbitration. The Company acknowledges that Executive will have the right to be represented by legal counsel at any arbitration proceeding.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c)**Questions of whether a claim is subject to arbitration under this Agreement shall be decided by the arbitrator. Likewise, procedural questions which grow out of the dispute and bear on the final disposition are also matters for the arbitrator. The arbitrator shall: (a) have the authority to compel adequate discovery for the resolution of the dispute and to award such relief as would otherwise be permitted by law; (b) issue a written arbitration decision, to include the arbitrator's essential findings and conclusions and a statement of the award; and (c) be authorized to award any or all remedies that Executive or the Company would be entitled to seek in a court of law. Executive and the Company shall equally share all JAMS' arbitration fees. Except as modified in the Covenants Agreements, each party is responsible for its own attorneys' fees.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(d)**Claims with respect to a threatened or actual breach of the Covenants Agreement or with respect to the Company's contractual, common law or statutory rights regarding the protection of trade secrets and/or confidential and proprietary information, are expressly <u>excluded</u> from the requirements of this Section 7.9. Accordingly, nothing in this Section 7.9 is intended to prevent or shall prevent the Company from instituting legal action (including immediately seeking injunctive or other equitable relief) in a court of competent jurisdiction in

------

Exhibit 10.10

connection with Executive's threatened or actual breach of the Covenants Agreement, or otherwise in connection with the Company's contractual, common law or statutory rights regarding the protection of its trade secrets and confidential and proprietary information.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(e)**To the extent applicable law prohibits mandatory arbitration of sexual harassment claims, in the event Executive intends to bring multiple claims, including a sexual harassment claim, the sexual harassment claim may be publicly-filed with a court, while any other claims will remain subject to mandatory arbitration.

# [SIGNATURES TO FOLLOW ON NEXT PAGE]

------

**IN WITNESS WHEREOF**, the parties have executed this Employment Agreement on the day and year first written above.

# SENSEI BIOTHERAPEUTICS, INC.
By: John Celebi

<u>/s/ John Celebi</u>

Its: President and CEO

Executive: <u>/s/ Christopher Gerry</u>

Christopher Gerry

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Date: 08/01/2024

------

## Exhibit 10.14

Exhibit 10.14

February 17, 2026 Christopher W. Gerry

# RE: AMENDMENT TO RETENTION AGREEMENT
Dear Chris:

This letter (this "Amendment") amends that certain Retention Agreement and Offer of Additional Severance Eligibility between you and Sensei Biotherapeutics, Inc. (the "Company") dated December 22, 2025 (the "Retention Agreement"). Capitalized terms not defined in this Amendment shall have the same meanings as set forth in the Retention Agreement or the Employment Agreement (as defined in the Retention Agreement).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.The section of the Retention Agreement titled "Second Retention Bonus" is hereby deleted in its entirety and replaced with the following:

## *Second Retention Bonus* 
If you remain employed by the Company through the date of the Company's next annual or special meeting of stockholders (the "Stockholder Meeting'), and provided you have not tendered your resignation before such date and the Company has not terminated your employment for Cause before the Stockholder Meeting, you will be entitled to receive a retention bonus equal to the sum of: (i) the aggregate of the cash severance payments described in Sections 6.2(a)(i) and 6.2(a)(iii) of the Employment Agreement, plus (ii) an amount equal to 1/12 of the Annual Bonus attributable to the 2026 calendar year, calculated at the full Modified Target Percentage, multiplied by the number of full months that you were employed by the Company in 2026 as of the Stockholder Meeting date (such total amount, the "Second Retention Bonus"). If earned, the Second Retention Bonus will be paid in a lump sum on the next regular payroll date following the Stockholder Meeting and will be subject to applicable payroll withholdings and deductions.

If the Company terminates your employment without Cause or you terminate your employment for Good Reason, in either case, prior to the Stockholder Meeting, then, subject to your full compliance with Section 6.1(c) of the Employment Agreement, including but not limited to the Release requirement, and your continued compliance with your obligations to the Company under the Covenants Agreement, the Company will pay you the Second Retention Bonus (with clause (ii) above calculated based on the number of full months you were employed by the Company in 2026 as of the date of termination of your employment), less applicable taxes and withholdings. Such payment will be made on the next regular payroll date after the Release has become effective. For the avoidance of doubt, the Second Retention Bonus is in addition to (and not in lieu of) any severance benefits payable to you pursuant to the Employment Agreement in connection with such termination of employment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.The section of the Retention Agreement titled "Additional Non-CIC Severance Benefit" is hereby deleted in its entirety.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.Except as expressly modified by this Amendment, all terms and conditions of the Retention Agreement remain in full force and effect.

------

Exhibit 10.14

If you would like to accept this Amendment, please sign below. Sincerely,

/s/ Bob Holmen

Name: Bob Holmen

Title: Chairman of the Board

Accepted and Agreed:

/s/ Christopher Gerry

Christopher W. Gerry

Date:2/17/2026

------

## Exhibit 10.15

Exhibit 10.15

February 17, 2026 Josiah Craver

# RE: AMENDMENT TO RETENTION AGREEMENT
Dear Josiah:

This letter (this "Amendment") amends that certain Retention Agreement and Offer of Additional Severance Eligibility between you and Sensei Biotherapeutics, Inc. (the "Company") dated December 22, 2025 (the "Retention Agreement"). Capitalized terms not defined in this Amendment shall have the same meanings as set forth in the Retention Agreement or the Employment Agreement (as defined in the Retention Agreement).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.The section of the Retention Agreement titled "Second Retention Bonus" is hereby deleted in its entirety and replaced with the following:

## *Second Retention Bonus* 
If you remain employed by the Company through the date of the Company's next annual or special meeting of stockholders (the "Stockholder Meeting'), and provided you have not tendered your resignation before such date and the Company has not terminated your employment for Cause before the Stockholder Meeting, you will be entitled to receive a retention bonus equal to the sum of: (i) the aggregate of the cash severance payments described in Sections 6.2(a)(i) and 6.2(a)(iii) of the Employment Agreement, plus (ii) an amount equal to 1/12 of the Annual Bonus attributable to the 2026 calendar year, calculated at the full Modified Target Percentage, multiplied by the number of full months that you were employed by the Company in 2026 as of the Stockholder Meeting date (such total amount, the "Second Retention Bonus"). If earned, the Second Retention Bonus will be paid in a lump sum on the next regular payroll date following the Stockholder Meeting and will be subject to applicable payroll withholdings and deductions.

If the Company terminates your employment without Cause or you terminate your employment for Good Reason, in either case, prior to the Stockholder Meeting, then, subject to your full compliance with Section 6.1(c) of the Employment Agreement, including but not limited to the Release requirement, and your continued compliance with your obligations to the Company under the Covenants Agreement, the Company will pay you the Second Retention Bonus (with clause (ii) above calculated based on the number of full months you were employed by the Company in 2026 as of the date of termination of your employment), less applicable taxes and withholdings. Such payment will be made on the next regular payroll date after the Release has become effective. For the avoidance of doubt, the Second Retention Bonus is in addition to (and not in lieu of) any severance benefits payable to you pursuant to the Employment Agreement in connection with such termination of employment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.The section of the Retention Agreement titled "Additional Non-CIC Severance Benefit" is hereby deleted in its entirety.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.Except as expressly modified by this Amendment, all terms and conditions of the Retention Agreement remain in full force and effect.

If you would like to accept this Amendment, please sign below.

------

Exhibit 10.15

Sincerely,

/s/ Christopher Gerry

Name: Christopher Gerry

Title: President and General Counsel

Accepted and Agreed:

/s/ Josiah Craver

Josiah Craver

Date: 2/17/2026

------

## Exhibit 10.19

Exhibit 10.19

*CERTAIN INFORMATION HAS BEEN EXCLUDED FROM THIS AGREEMENT (INDICATED BY "[\*\*\*]") BECAUSE SUCH INFORMATION IS BOTH (A) NOT MATERIAL AND (B) THE TYPE THAT THE REGISTRANT CUSTOMARILY AND ACTUALLY TREATS AS PRIVATE OR CONFIDENTIAL.*

EXCLUSIVE LICENSE AGREEMENT

between

THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

and

INTELLIKINE, INC.

for

[\*\*\*]

Intellikine License Agreement SV21274327 v25

------

**<u>Exhibit 10.19</u>**

**TABLE OF CONTENTS**

<u>Article No.</u> <u>Title</u> Page

(N/A) **BACKGROUND 1**

**1. DEFINITIONS 3**

**2. GRANT 11**

**3. SUBLICENSES 13**

**4. PAYMENT TERMS 17**

**5. LICENSE ISSUE FEE 19**

**6. LICENSE MAINTENANCE FEE 19**

**7. SUBLICENSING REVENUE FEE 20**

**8. EARNED ROYALTIES AND MINIMUM ANNUAL ROYALTIES 21**

**9. MILESTONE PAYMENTS 23**

**10. DUE DILIGENCE 24**

**11. PROGRESS AND ROYALTY REPORTS 28**

**12. BOOKS AND RECORDS 32**

**13. TERM OF THIS AGREEMENT 32**

**14. TERMINATION BY THE REGENTS 33**

**15. TERMINATION BY LICENSEE 34**

**16. DISPOSITION OF LICENSED PRODUCTS AND LICENSED SERVICES UPON TERMINATION OR EXPIRATION 34**

**17. USE OF NAMES AND TRADEMARKS 35**

**18. LIMITED WARRANTY 35**

**19. LIMITATION OF LIABILITY 36**

------

**<u>Exhibit 10.19</u>**

**20. PATENT PROSECTUTION AND MAINTENANCE 36**

**21. PATENT MARKING 39**

**22. PATENT INFRINGEMENT 39**

**23. INDEMNIFICATION 41**

**24. NOTICE; PAYMENTS 44**

**25. ASSIGNABILITY 45**

**26. WAIVER 46**

**27. FORCE MAJEURE 46**

**28. GOVERNING LAWS; VENUE; ATTORNEYS FEES 46**

**29. GOVERNMENT APPROVAL OR REGISTRATION 46**

**30. COMPLIANCE WITH LAWS 47**

**31. CONFIDENTIALITY 47**

**32. MISCELLANEOUS 49**

------

**<u>Exhibit 10.19</u>**

EXCLUSIVE LICENSE AGREEMENT

for

[\*\*\*]

This license agreement (the "<u>Agreement</u>") is made effective as of August 10, 2007 (the <u>"Effective Date"</u>), by and between The Regents of the University of California, a California corporation having its statewide administrative offices at 1111 Franklin Street, 12th Floor, Oakland, California 94607-5200 ("<u>The Regents</u>") and acting through its Office of Technology Management, University of California San Francisco, 185 Berry Street, Suite 4603, San Francisco, CA 94107 ("<u>UCSF</u>"), and Intellikine, Inc., a Delaware corporation having a principal place of business at 575 Old Mill Road, San Marino, CA 91108 (the "<u>Licensee</u>").

BACKGROUND

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;A. Certain inventions, generally characterized as [\*\*\*]) (collectively, the "<u>Invention</u>"), were made in the course of research at UCSF, by [\*\*\*], all employees of UCSF, and [\*\*\*], an employee of the Howard Hughes Medical Institute ("<u>HHMI</u>") and a member of the faculty of UCSF, (collectively, the "<u>Inventors</u>") and are claimed in the Patent Rights as defined below.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;B. The development of the Invention was sponsored in part by the United States Department of Health and Human Services and, as a consequence, this license is subject to overriding obligations to the United States Federal Government under 35 U.S.C. §§ 200-212 and applicable regulations including a non-exclusive, non-transferable, irrevocable, paid-up license to practice or have practiced the Invention for or on behalf of the United States Government throughout the world.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;C. HHMI assigned its rights in the Invention to The Regents under the terms of the interinstitutional agreement by The Regents with HHMI having UC Control No. [\*\*\*] (the "<u>HHMI Interinstitutional Agreement</u>"), and accordingly, The Regents has the authority to license the entire interest in the Invention and any patent rights claiming the Invention. Under the terms of the HHMI Interinstitutional Agreement, The Regents will provide HHMI with one copy of the fully executed Agreement, which will be maintained as confidential by HHMI pursuant to the terms of the HHMI Interinstitutional Agreement.

------

**<u>Exhibit 10.19</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;D. Under the terms of the HHMI Interinstitutional Agreement, HHMI has reserved a non-exclusive, paid-up, royalty-free, irrevocable license, with no right to assign or sublicense others, to make and use the Invention for research purposes only.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;E. The Licensee has evaluated the Invention under a Secrecy Agreement with The Regents with an effective date of [\*\*\*] (the "<u>Secrecy Agreement</u>").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;F. The Licensee and The Regents have executed a Letter of Intent (UC Control No. [\*\*\*]) with an effective date of [\*\*\*] (the "<u>Letter of Intent</u>").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;H. The Licensee wishes to obtain certain rights from The Regents for the commercial development of the Invention, in accordance with the terms and conditions set forth herein and The Regents is willing to grant those rights to the Licensee so that the Invention may be developed and the benefits thereof enjoyed by the general public.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;I. The scope of such rights granted by The Regents is intended to extend to the scope of the patents and patent applications in the Patent Rights, but only to the extent that The Regents has proprietary rights in and to the Valid Claims of such Patent Rights.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;J. The Licensee is a "small business firm" as defined in 15 U.S.C. §632.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;K. Both parties hereto recognize and agree that Earned Royalties are due under this Agreement, with respect to Products, services and methods and that such royalties will be paid with respect to both pending patent applications and issued patents, in accordance with the terms and conditions set forth herein.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;L. The Licensee acknowledges that: (i) consideration for Technology Rights is being paid to The Regents due to the grant by The Regents to the Licensee of early access to the Invention; (ii) some of the technology in Technology Rights may become public without a decrease in consideration due to The Regents under this Agreement; and (iii) while the Licensee is subject to restriction as to dissemination of technology in Technology Rights, The Regents may make such technology available to others without restriction.

M. [\*\*\*]

The parties hereto agree as follows:

1. DEFINITIONS; CERTAIN REFERENCES

As used in this Agreement, the following terms, whether used in the singular or plural, will have the following meanings; other initially-capitalized terms used in this Agreement and not defined in this Article 1 will have such meaning for such term as is set forth for such term

------

**<u>Exhibit 10.19</u>**

elsewhere in this Agreement; references in this Agreement to Articles and Sections are to Articles and Sections of this Agreement:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1 "<u>action</u>" means any action, litigation or suit brought in law or in equity.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.2 An "<u>Affiliate</u>" means any entity which, now or at any time during the term of this agreement, directly or indirectly, Controls the Licensee, is Controlled by the Licensee or is under common Control with the Licensee, but only for so long as such Control continues, where "<u>Control</u>" means (a) having the actual, present capacity to elect a majority of the members of the Board of Directors, or other governing body, of such Affiliate; (b) having the power to direct at least fifty percent (50%) of the voting rights entitled to elect members of the Board of Directors or other governing body of such Affiliate, or (c) in any Country where local law will not permit foreign equity participation of a majority of such voting rights, then Control will mean ownership or control, directly or indirectly, of the maximum percentage of such outstanding stock or other equity interest or voting rights as is permitted by local law for foreign equity participation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.3 "<u>Annual License Maintenance Fee</u>" has the meaning assigned to it in Article 6.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.4 "<u>Biological Material</u>" has the meaning assigned to it in Section 31.6.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.5 "<u>Claims</u>" has the meaning assigned to it in Section 23.l.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.6 "<u>Combined Product or Service</u>" means a combined Product or Service that contains or uses a Licensed Product, Licensed Method, or Licensed Service, and at Least one other Product or process (a "<u>Combination Component</u>"), together, where (a) such Combination Component is not itself a Licensed Product, Licensed Method, or Licensed Service, (b) if such Combination Component(s) were removed from such combined Product or Service, the manufacture, use, Sale or import of the resulting Product or Service in or into a particular Country would infringe, but for a license, the same Valid Claim in the Country where such manufacture, use, Sale or import occurs as such combined Product or Service, (c) such Combination Component and such Licensed Product, Licensed Method, or Licensed Service are Sold separately, or if not at the time being Sold by any party can be Sold separately, whether in either case by Licensee or by any Sublicensee or by any other party, (d) such Combination Component does not, by itself or together with a Licensed Product, Licensed Method, or Licensed Service, function so as to achieve the same purpose for which such Licensed Product, Licensed Method, Licensed Service is Sold [\*\*\*].

------

**<u>Exhibit 10.19</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.7 "<u>Country</u>" or "<u>Countries</u>" means a state or nation or other geographically-defined jurisdiction, as relevant.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.8 "<u>dollars</u>" means United States dollars.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.9 "<u>Earned Royalties</u>" has the meaning assigned to it in Article 8.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.10 "<u>Exploitation</u>" or "<u>Exploited</u>" means any use which is permitted by this Agreement but which does not give rise to Net Sales.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.11 "<u>FDA</u>" means the United States Food & Drug Administration.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.12 "<u>Field of Use</u>" means all fields and all uses.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.13 "<u>foreign</u>" means outside of the United Stales.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.14 "<u>Gross Invoice Price</u>" means the Gross Invoice Price charged by, and the value of any other consideration owed to, under legally binding written or oral agreements, the Licensee or Direct Sublicensee or Secondary Sublicensee, as relevant, with respect to the Sale or other disposition of a Licensed Product or Licensed Service, or from a Combined Product or Service, as the case may be.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.15 "<u>HHMI Indemnitees</u>" has the meaning assigned to it in Section 23.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.16 "<u>Infringement Notice</u>" has the meaning assigned to it in Section 22.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.17 "<u>Joint Venture</u>" means any separate entity established pursuant to an agreement between a third party and the Licensee and/or any Sublicensee to constitute a vehicle for a joint venture, in which the separate entity manufactures, uses, purchases, Sells or acquires Licensed Products from the Licensee or front such Sublicensee.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.18 "<u>Know-How</u>" means any unpatented proprietary information that exists as of the Effective Date, including without limitation, ideas, concepts, formulas, methods, designs, plans, and any information relating to research and development plans, preclinical and clinical data, chemical synthesis, scale-up and manufacturing, toxicology, regulatory, stability, and biochemical or cellular screening data obtained in UCSF laboratories as of the Effective Date and which are described in <u>Appendix A</u> with respect to compounds under UC Case Nos. [\*\*\*] which have been synthesized by the Effective Date, and any other information relevant to manufacture, development, commercialization; all of which were developed solely in the laboratory of [\*\*\*], by [\*\*\*] or by others working under [\*\*\*] direct supervision, at UCSF and embodied by the Patent Rights.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.19 "<u>License</u>" has the meaning assigned to it in Section 2.1.

------

**<u>Exhibit 10.19</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.20 "<u>License Issue Fee</u>" has the meaning assigned to it in Section 5.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.21 "<u>Licensed Method</u>" means any process, art or method the use or practice of which in the relevant Country, but for the License, would infringe, or contribute to, or induce the infringement of, any of the Patent Rights if such relevant Patent Rights were issued and in effect and valid at the time of the infringing activity in such Country.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.22 "<u>Licensed Product</u>" means any Product, including, without limitation, a Product for use or used in practicing a Licensed Method and any Product made by practicing a Licensed Method, and including [\*\*\*] Licensed Products and [\*\*\*] Licensed Products, as defined in Section 1.23 and 1.24 respectively, the manufacture, use, Sale, offer for Sale or import of which in each case in the relevant Country, but for the License, would infringe, or contribute to, or induce the infringement of, any of the Patent Rights if such relevant Patent Rights were issued and in effect and valid at the time of such infringing activity in the relevant Country.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.23 "[<u>\*\*\*] Licensed Product</u>" means a Licensed Product covered by a Valid Claim in any of the Patent Rights that claim priority to [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.24 "[<u>\*\*\*] Licensed Product</u>" means a Licensed Product covered by a Valid Claim in any of the Patent Rights that claim priority to [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.25 "<u>Licensed Service</u>" means any Service provided for consideration (whether in cash or any other form), when such Service (a) involves the use of a Licensed Product, and/or (b) involves the practice of a Licensed Method, and/or (c) involves the use of Technology Rights.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.26 "<u>Milestone Payment</u>" has the meaning assigned to it in Section 9.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.27 "<u>Minimum Annual Royalty</u>" has the meaning assigned to it in Section 8.2.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.28 "<u>Net Sales</u>" means, as relevant, (a) all proceeds actually received by the Licensee or by a Sublicensee from the Sale of any Licensed Product, Licensed Method, or Licensed Service, or (b) all proceeds actually received by the Licensee or by a Sublicensee from the Sale of any Combined Product or Service, in the case of both (a) and (b) above subject to the provisions of subsections (1) through (3) which immediately follow subsection 1.28.7; less in each case the following items, but only to the extent that such item in each case actually pertains to the Sale of such Licensed Product, Licensed Method or Licensed Service, or Combined Product or Service, and are separately billed (the "<u>Deductions</u>"):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.28.1 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.28.2 [\*\*\*]

------

**<u>Exhibit 10.19</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.28.3 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.28.4 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.28.5 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.28.6 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.28.7 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) [\*\*\*]

[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(3) [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.29 "<u>New Developments</u>" means inventions, or claims to inventions, which constitute advancements, developments or improvements, whether or not patentable and whether or not the subject of any patent application, which are not sufficiently supported by the specification of a previously-filed patent or patent application within the Patent Rights to be entitled to the priority date of the previously-filed patent or patent application.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.30 "<u>Notice of Default</u>" has the meaning assigned to it in Article 14.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.31 "<u>Original Materials</u>" means physical material of one or more of the chemical compounds listed in <u>Appendix A</u> attached hereto and incorporated herein by reference that exists as of the Effective Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.32 "<u>Patent Prosecution Costs</u>" means the costs of preparing, filing, prosecuting and maintaining all United States and foreign patent applications contemplated by this Agreement including, without limitation, patent prosecution costs for the Invention incurred by The Regents prior to the execution of this Agreement and any patent prosecution costs that may be incurred for patentability opinions, re-examination, re-issue, interferences, oppositions or inventorship determinations, and patent maintenance expenses, in each case during the term of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.33 "<u>Patent Rights</u>" means the Valid Claims of, to the extent assigned to or otherwise obtained by The Regents, the following United States patents and patent applications:

[\*\*\*]

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**<u>Exhibit 10.19</u>**

The Patent Rights will further include (a) the Valid Claims of, to the extent assigned to or otherwise obtained by The Regents, the corresponding foreign patents and patent applications (as may be requested by the Licensee of The Regents pursuant to Section 20.5) and (b) any reexaminations, extensions or restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates or the equivalent thereof, reissues, substitutions, continuations, divisions, and continuation-in-part (but only those Valid Claims in the continuation-in-part that are entirely supported in the specification of the parent application and entitled to the priority date of the parent application), but excludes any rights in and to New Developments.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.34 "<u>Product</u>" means any kit, article of manufacture, composition of matter, material, compound, component or other product.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.35 "<u>Proprietary Information</u>" has the meaning assigned to it in Section 31.1

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.36 "<u>Sale</u>," "<u>Sell,</u>" and "<u>Sold</u>", "<u>Sale</u>" means the act of selling, leasing or otherwise transferring, providing, or furnishing or disposing for use, in each case for any consideration (regardless of the form of the consideration), which if non-cash will have the monetary value in dollars that would be obtained for such consideration in an arms length transaction at the time of such transfer, provision, furnishing, or disposition, and provided that if either party hereto disputes in good faith the determination by the other party hereto as to such monetary value, the parties will discuss and resolve such matter promptly and in good faith. "<u>Sell</u>" means to make a Sale or to cause a Sale to be made. "<u>Sold</u>" means to have made a Sale or to have caused a Sale to be made. Licensed Products provided by the Licensee or any Sublicensee for administration in preclinical trials, and to patients in clinical trials, or to be distributed through a not-for-profit foundation or other not-for-profit organization at no charge or at a nominal charge by such foundation or organization to eligible patients, in each case will not be deemed to be Sold (but will be deemed to be Exploited), if in such case the relevant providing party (as among the Licensee and Sublicensees) receives no consideration from the party conducting such preclinical trials or clinical trials, nor otherwise from such preclinical trials or clinical trials, nor from such not-for-profit foundations or organizations, as relevant, for such use of such Licensed Products, and provided that (a) the obtaining by the providing party (as among the Licensee and

Sublicensees) of rights to data or results of any preclinical trials or clinical trials will not be deemed to be the receipt of consideration by the providing party (as among the Licensee and

------

**<u>Exhibit 10.19</u>**

Sublicensees), and (b) the provision by the providing party (as among the Licensee and Sublicensees) of any Licensed Products to their respective third party consultants and contractors for the purpose of performing research on and/or development of a Licensed Product or Licensed Service for the providing party will not be deemed to be a Sale but will be deemed to be an Exploitation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.37 "<u>Service</u>" means any service provided for consideration (whether in cash or any other form).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.38 "<u>Sublicensee</u>" means any Direct Sublicensee or Secondary Sublicensee.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.39 "<u>Direct Sublicensee</u>" means any person or entity (including any Affiliate or Joint Venture) to which any of the License rights granted to the Licensee hereunder are sublicensed by the Licensee.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.40 "<u>Secondary Sublicensee</u>" mean any party to whom a Direct Sublicensee sublicenses rights under, and to the extent permitted by, such Sublicensee's sublicense from the Licensee pursuant to this Agreement.

1.41 "<u>Sublicensing Revenues</u>" means amounts, whether consisting of cash or any other form of consideration (including, "without limitation, any licensing fees, maintenance fees, or milestone payments), received by or payable to the Licensee from any Direct Sublicensee (including any Affiliate and/or Joint Venture), in each case in consideration of, as relevant, the grant of a sublicense hereunder by the Licensee to such Direct Sublicensee or the grant of a sublicense hereunder by the Direct Sublicensee to a Secondary Sublicensee, provided that Sublicensing Revenues will not include amounts so received by or payable to the Licensee that are reasonably and fairly attributable to any of the following [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.42 "<u>Technology Rights</u>" means (a) The Regents' personal property rights in the Original Materials; and (b) The Regents' personal proprietary rights in Know-How which exist as of the Effective Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.43 "<u>Valid Claim</u>" means (a) a pending claim of a patent application that is included under Patent Rights, that is being prosecuted diligently and in good faith pursuant to Section 20, or (b) an issued claim of any such patent in any Country that (i) has not expired; (ii) has not been disclaimed; (iii) has not been cancelled or superseded, or if cancelled or superseded, has been reinstated; and (iv) has not been revoked, held invalid, or otherwise declared unenforceable or

------

**<u>Exhibit 10.19</u>**

not allowable by a tribunal or patent authority of competent jurisdiction over such claim in such Country from which no further appeal has or may be taken.

2. GRANT

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1 Subject to the limitations and other terms and conditions set forth in this Agreement including the license granted to the United States Government, and those reserved by HHMI, set forth in each case under "Background" at the beginning of this Agreement, and in Section 2.3.1, The Regents grants to the Licensee a license (the "<u>License</u>"), to make, have made, use, Sell, offer for Sale and import Licensed Products and Licensed Services and to practice Licensed Methods, in the United States, and in all other Countries where The Regents may lawfully grant such license rights, in the Field of Use, which grant includes the right of the Licensee to grant sublicenses as set forth in Article 3.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2 Except as otherwise provided for in this Agreement, the License granted under Patent Rights in Section 2.1 (the "<u>Patent Rights License</u>") is exclusive. Except as otherwise provided for in this Agreement, the License granted under Technology Rights in Section 2.1 (the "<u>Technology Rights License</u>") is non-exclusive.

The License is subject to the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.3.1 The obligations to the United States Government under 35 U.S.C. §§ 200-212 and all applicable governmental implementing regulations, as amended from time to time, including the obligation to report on the utilization of the Invention as set forth in 37 CFR. § 401.14(h), and all applicable provisions of any license to the United Stares Government executed by The Regents. The licenses granted hereunder also will be subject to the paid-up, non-exclusive, irrevocable licenses reserved by HHMI to make and use the Invention for its academic research purposes only, but with no right to commercialize itself (where research collaboration agreements between HHMI and non-profit and/or for-profit entities are not considered to be "commercialization"), nor to grant to any sponsor of any work done at HHMI, or done by or on behalf of any such collaborator, any rights to commercialize the results thereof. Such licenses reserved by HHMI specified in the recitals and the immediately prior sentence are non-transferable and do not include the right to sublicense

------

**<u>Exhibit 10.19</u>**

others. Moreover, the Licenses granted to Licensee hereunder also are subject to HHMI's statement of policy on research tools, which can be found at: [\*\*\*]; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.3.2 The National Institutes of Health "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources," 64 F.R. 72090 (Dec. 23, 1999), as amended from time to time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4 Title in and to the Original Materials and any rights, including any and all intellectual property rights, relating thereto is owned by The Regents and is not transferred to the Licensee under this Agreement. The Licensee may receive samples of certain Original Materials from [\*\*\*] or from a representative of The Regents, including other personnel of UCSF, pursuant to this Agreement. The Licensee may use such Original Materials solely as necessary to exercise the rights granted to the Licensee hereunder, provided, however, in no event may the Licensee Sell or otherwise dispose of or provide such Original Materials to any third party except solely as provided for in Section 31.6.2. The Licensee will notify The Regents in writing if the Licensee receives, pursuant to this Agreement, any material from [\*\*\*], or from any representative of The Regents, which is not listed in Appendix A hereto, and if the Licensee receives any such material, the Licensee may not use such material without the written permission of The Regents.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.5 The Regents reserves and retains the right (and the rights granted to the Licensee in this Agreement will be limited accordingly) to make, use and practice the Invention, the Technology Rights and any technology relating to any of the foregoing and to make and use any Products and to practice any process that is the subject of the Patent Rights (and to grant any of the foregoing rights to other educational and non-profit institutions, using the general form of the Material Transfer Agreement attached hereto as <u>Appendix C)</u> for educational and research purposes only, including without limitation, any sponsored research performed for or on behalf of commercial entities and including the right to publish and communicate any research results, but with no right to grant rights to any such sponsor for profit-making or commercial uses under the Patent Rights exclusively licensed to Licensee. To the extent that the Invention, the Technology Rights, the Original Materials, and any technology relating to any of the foregoing are not the subject of the exclusive license granted to the Licensee hereunder, The Regents will

------

**<u>Exhibit 10.19</u>**

be free to make, use, Sell, offer to Sell, import, practice and otherwise commercialize and exploit (including to transfer, license to, or have exercised by, third parties hereto) for any purpose whatsoever and in its sole discretion, such Invention, Technology Rights, Original Materials, and any technology and any Products or processes that are the subject of any of the foregoing.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.6 Because the Invention was made under funding provided by the United States Government, any tangible materials comprising the Invention, and any Products, including any Licensed Products, embodying the Invention that in each case are sold in the United States will be substantially manufactured in the United States.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.7 To the extent The Regents is legally able to do so, and only to the extent of the actual knowledge of the licensing professional within UCSF responsible for management of this Agreement without an affirmative duty to inquire, The Regents will use its commercially reasonable efforts to notify Licensee in writing of any publication made by [\*\*\*] relating to [\*\*\*].

3. SUBLICENSES

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1 The License granted under Article 2 includes the right of the Licensee, for as long as the License is exclusive pursuant to the terms of this Agreement, to sublicense to Direct Sublicensees (including to Affiliates and Joint Ventures) any of the rights granted to the Licensee hereunder, on an exclusive or non-exclusive basis, as to the Patent Rights under the Patent Rights License, as determined by the Licensee, and solely on a non-exclusive basis as to the Technology Rights under the Technology Rights License, and provided that the Licensee may not sublicense any Technology Rights to a Sublicensee except in connection with a sublicense by the Licensee to Patent Rights to the same Sublicensee. Notwithstanding the foregoing, and subject to the further provisions of this Section 3.1 providing for [\*\*\*]. The Licensee may grant its Direct Sublicensee(s) the right to further sublicense to Secondary Sublicensee(s) any of the rights granted to the Licensee hereunder, but not greater than the rights granted by the Licensee to such relevant Direct Sublicensee, provided that if such Secondary Sublicensee is an entity that is not an Affiliate of the Direct Sublicensee and such sublicense would grant rights to the Secondary Sublicensee to uses of the Patent Rights or Technology Rights other than for the development, manufacture, marketing and Sales of Licensed Products (a) that are substantially similar to those that are developed or under development by the Direct Sublicense during the term of the sublicense to such Direct Sublicensee from the Licensee, or (b) that are anticipated, in writing

------

**<u>Exhibit 10.19</u>**

between the Direct Sublicensee and the Licensee, to be developed under the sublicense to the Direct Sublicensee for human therapeutic uses, then [\*\*\*]. Each grant of a sublicense by the Licensee to any Direct Sublicensee, and by any Direct Sublicensee to any Secondary Sublicensee, must be pursuant to a written sublicense agreement, which sublicense agreement will include all of the terms, conditions, obligations and other restrictions of this Agreement that protect or benefit HHMI's and The Regents', and, as applicable, the United States Government's, rights and interests, other than those terms, conditions and obligations specified in [\*\*\*], and which will provide (1) that if any rights under the Patent Rights License [\*\*\*] to the Licensee as provided in this Agreement, then such sublicense, if it is not already [\*\*\*], will automatically [\*\*\*], and (2) for [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2 Affiliates and Joint Ventures will have no licenses or rights under this Agreement unless such Affiliate or Joint Venture is granted a sublicense, as a Direct Sublicensee, by the Licensee hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.3 If The Regents and the Licensee each own an undivided interest in any Patent Rights licensed hereunder (for example, by jointly owning rights in any continuation-in-part under any Patent Rights), the Licensee will not separately grant a license to any third party under such rights of the Licensee without concurrently granting a sublicense to such third party (which third party thus will be a Direct Sublicensee), as to the rights granted to the Licensee under this Agreement, on the terms and conditions described in this Article 3.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.4 The Licensee will notify The Regents in writing, within [\*\*\*] the grant by the Licensee or a sublicense hereunder to a Direct Sublicensee, or after any amendment to any such granted sublicense, and will with such notice provide The Regents with a complete copy of each sublicense or of such, amendment, as relevant. All such notices and copies of such sublicenses made under this Agreement, and of amendments thereto, will be deemed to be Proprietary Information of the Licensee as so delivered to The Regents.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.5 All Net Sales made by Sublicensee will, for the purpose of Earned Royalties and Minimum Annual Royalties due from the Licensee to UCSF under this Agreement by the Licensee, be deemed to be Net Sales by the Licensee, and the Licensee will collect from Direct Sublicensees and, directly from Secondary Sublicensees or through the relevant Direct Sublicensee, and will, subject to the provisions of Section 3.5.1, pay to The Regents when due

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**<u>Exhibit 10.19</u>**

hereunder as if such Net Sales had been made by the Licensee, all fees, payments and royalties due to be paid to The Regents hereunder as if Net Sales were made by the Licensee, such that if the Licensee grants a sublicense that contains a provision for payment of royalties by any Sublicensee in an amount that is less than the Sublicensee Royalty required to be paid under Section 8.1, then the Licensee will pay to The Regents a total amount equal to the Sublicensee Royalty based on the Sublicensees' Net Sales as provided for in Section 8.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.5.1 The Licensee does not guarantee any monies due The Regents from Sublicensees that are not received by the Licensee. Any failure of the Licensee to pay to The Regents any amounts of Net Sales of any Sublicensee before the Licensee receives such amounts from such Sublicensee under the relevant sublicense will not be a breach of the Licensee's obligations under this Agreement to pay to The Regents amounts as to Net Sales of such Sublicensee, provided that the Licensee (a) [\*\*\*], (b) [\*\*\*], (c) will notify The Regents in writing of any such default within [\*\*\*], (d) will, within [\*\*\*] pay to The Regents the amount due hereunder from the Licensee with respect to the Net Sales of such Sublicensee to which such payment by the Sublicensee to the Licensee relates, and (e) will enact a plan, which will be mutually agreed upon by the Licensee and The Regents within [\*\*\*], for addressing such Sublicensee's default if such default has not been cured prior to [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.5.2 If at any time legal restrictions prevent the prompt remittance of Earned Royalties or other consideration owed to The Regents by the Licensee with respect to any Country where a sublicense is issued or a Licensed Product or Licensed Service is Sold, then the Licensee will not be in breach of its obligations of payment hereunder to The Regents so long as (i) the Licensee has notified The Regents in writing of the legal restriction preventing remittance within [\*\*\*], and (ii) the Licensee is enacting a plan, which will be mutually agreed upon by The Regents and Licensee within [\*\*\*], under which Licensee will [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.5.3 The Licensee will require each Sublicensee to provide the Licensee with all progress reports and royalty reports in accordance with the provisions

------

**<u>Exhibit 10.19</u>**

hereof which are applicable to the Licensee, as to Net Sales by such Sublicensee, and the Licensee will deliver to The Regents a copy of all such reports from such Sublicensees. All such reports will be deemed to be Proprietary Information of the Licensee as so delivered to The Regents.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6 If the Licensee licenses to any third party (including any Direct Sublicensee) any patent rights assigned to or otherwise acquired by the Licensee apart from the Patent Rights to which the Licensee has rights under the License ("<u>Licensee's Patent Rights</u>"), and the Licensee believes, in good faith, that such third party licensee will, under such third party licensee's exercise of such rights so licensed to the Licensee's Patent Rights, infringe any of the Patent Rights, then the Licensee will not separately grant a license to such third party licensee under Licensee's Patent Rights without concurrently granting a sublicense to such third party licensee, in such case as a Direct Sublicensee, under the Patent Rights on the terms required under this Agreement for such sublicense to a Direct Sublicensee.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.7 [\*\*\*]

4. PAYMENT TERMS

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.1 Earned Royalties are payable on Net Sales of Licensed Products and Licensed Services covered by a Valid Claim within the Patent Rights. Earned Royalties will accrue in each Country for the duration of the Patent Rights in such Country and will be payable to The Regents when Licensed Products or Licensed Services are invoiced, or if not invoiced, when delivered or otherwise Sold by the Licensee or Sublicensee.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.2 The Licensee will pay to The Regents all Earned Royalties, Sublicensing Revenues Fees and other consideration payable to The Regents under this Agreement [\*\*\*], as to Earned Royalties, Sublicensing Revenues Fees and other consideration which has accrued within the Licensee<u>'</u>s most recently completed [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.3 All consideration due The Regents by the Licensee under this Agreement will be paid in dollars by check payable to "The Regents of the University of California" or by wire transfer to an account designated by The Regents in writing to the Licensee. [\*\*\*]. When Licensed Products or Licensed Services are Sold for monies other than dollars, amounts due to be paid by the Licensees to The Regents under this Agreement will first be determined in the foreign currency of the Country in which such Licensed Products or Licensed Services were Sold

------

**<u>Exhibit 10.19</u>**

and then will be converted into dollars. The exchange rate for such conversion into dollars will be [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.4 Sublicensing Revenues Fees and Earned Royalties on Net Sales of Licensed Products or Licensed Services and other consideration accrued in any Country outside the United States [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.5 If any patent or claim thereof included within the Patent Rights is held invalid in a final decision by a court of competent jurisdiction and last resort and from which no appeal has been taken or can be taken, then all obligation to pay royalties based on that patent or claim or any claim patentably indistinct therefrom will cease as of the date of such final decision, provided that the Licensee will not be relieved from paying any royalties hereunder that accrued before such final decision, and the Licensee will be obligated to pay the full amount of royalties due hereunder to the extent that The Regents licenses one or more Valid Claims within the Patent Rights to the Licensee, under the License, with respect to Licensed Products or Licensed Services.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.6 No Earned Royalties will be collected or paid hereunder to The Regents on Licensed Products or Licensed Services Sold to, or otherwise Exploited for, the account of the United States Government as provided for in the license rights reserved hereunder to the United States Government. The Licensee, and any Sublicensee, will reduce the amount charged for Licensed Products or Licensed Services Sold to the United States Government by an amount equal to the Earned Royalties for such Licensed Products or Licensed Services otherwise due to The Regents hereunder. Such reduction in Earned Royalties will be in addition to any other reductions in price for such Licensed Products and/or Licensed Services required by the United States Government.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.7 In the event that royalties, fees, reimbursements for Patent Prosecution Costs or other monies owed to The Regents under this Agreement have not been received by The Regents when due, the Licensee will pay to The Regents, in addition to such due amounts, interest on such due amounts at the rate of [\*\*\*], with such interest calculated from the date payment was due until such payment actually is received by The Regents. Such accrual of interest will be in addition to and not in lieu of, enforcement of any other rights of The Regents due to such late payment.

5. LICENSE ISSUE FEE

------

**<u>Exhibit 10.19</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.1 The Licensee will pay to The Regents a license issue fee (the "<u>License Issue Fee</u>") in cash of [\*\*\*] for the grant herein of the License. Of such License Issue Fee, the Licensee will pay (a) [\*\*\*)] to The Regents within [\*\*\*]; and (b) [\*\*\*] to The Regents on the date [\*\*\*]; and (c) [\*\*\*] to The Regents on the date [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.2 The License Issue Fee is non-refundable, non-cancelable and is not an advance, or otherwise creditable, against any amounts required to be paid by the Licensee under the terms of this Agreement (excluding any withholding tax due the United States Government).

6. ANNUAL LICENSE MAINTENANCE FEE

The Licensee will also pay to The Regents a license maintenance fee (the "<u>Annual License Maintenance Fee</u>") of [\*\*\*] beginning on, and payable within [\*\*\*], and payable within [\*\*\*] during the term hereof, until such time as the Licensee is Selling or otherwise Exploiting Licensed Products or Licensed Services and is paying Earned Royalties to The Regents. No Annual License Maintenance Fee will be due or payable, other than any such Annual License Maintenance fee which otherwise then is due and payable as to prior periods and which has not yet been paid by the Licensee to The Regents, from and after the date upon which the first obligation of the Licensee hereunder to pay any Earned Royalties to The Regents has accrued. Amounts paid by the Licensee to The Regents as Annual License Maintenance Fees are non-refundable, non-cancelable, and will not be credited as an advance against, or otherwise creditable against, any other amounts due from the Licensee to The Regents under this Agreement.

7. SUBLICENSING REVENUE FEE

The Licensee will pay to The Regents the following fee (the "<u>Sublicensing Revenues</u> <u>Fees</u>") with respect to all Sublicensing Revenues, which amounts will be non-refundable and which will not be credited against any other amounts due from the Licensee to The Regents under this Agreement:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.1.1 [\*\*\*] of all Sublicensing Revenues, received by the Licensee, attributable [\*\*\*], if such sublicense is executed prior to [\*\*\*]; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.1.2 [\*\*\*] of all Sublicensing Revenues, received by the Licensee, attributable to [\*\*\*], if such sublicense is executed after \*\*\*], but prior to [\*\*\*]; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.1.3 [\*\*\*] of all Sublicensing Revenues, received by the Licensee, attributable to [\*\*\*], if such sublicense is executed after [\*\*\*], but prior to [\*\*\*]; or

------

**<u>Exhibit 10.19</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.1.4 [\*\*\*] of all Sublicensing Revenues, received by the Licensee, [\*\*\*], if such sublicense is executed after [\*\*\*]; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.1.5 [\*\*\*] of all Sublicensing Revenues, received by the Licensee, attributable to any sublicense by the Licensee to a Direct Sublicensee, if such sublicense [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.2 [\*\*\*]

8. EARNED ROYALTIES AND MINIMUM ANNUAL ROYALTY

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.1 In addition to the License Issue Fee, the Annual License Maintenance Fee and the Sublicensing Revenues Fees, Licensee will also pay to The Regents, with respect to Net Sales of the Licensee and its Affiliates and Joint Ventures, and of each Direct Sublicensee other than (in order to avoid duplication) an Affiliate or Joint Venture, and of each Secondary Sublicensee, the following Earned Royalties in cash (the "<u>Earned Royalties</u>"); Earned Royalties will be payable on Net Sales covered by pending patent applications and on Net Sales covered by issued patents, in each case as licensed to the Licensee hereunder:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.1.1 [\*\*\*] with respect to cumulative Net Sales by, collectively, the Licensee and Direct Sublicensees and Secondary Sublicensees, from and after the Effective Date, up to and including [\*\*\*]; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.1.2 [\*\*\*] with respect to Cumulative Net Sales by collectively the Licensee and Direct Sublicensee and Secondary Sublicensees, from and after the Effective Date, in excess of [\*\*\*] up to and including [\*\*\*]; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.1.3 [\*\*\*] with respect to cumulative Net Sales by collectively the Licensee and Direct Sublicensees and Secondary Sublicensees, from and after the Effective Dale, above [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.2 The Licensee will also pay to The Regents a Minimum Annual Royalty (the "<u>Minimum</u> <u>Annual Royalty</u>") of [\*\*\*] in cash for [\*\*\*] during the term hereof, beginning with the year in which the first Sale of the first Licensed Product to be Sold occurs. Such Minimum Annual Royalty will be paid to The Regents by [\*\*\*] and will be credited against the Earned Royalties due for the [\*\*\*] in which such payment of the Minimum Annual Royalty was made. The Licensee's obligation to pay the Minimum Annual Royalty in the [\*\*\*] in which such first Sale occurs will be prorated for [\*\*\*] and will be due the next-occurring [\*\*\*] (along with the Minimum Annual Royalty payment for such [\*\*\*]), to allow for crediting of such prorated [\*\*\*]

------

**<u>Exhibit 10.19</u>**

Earned Royalties. Licensee's obligation to pay a Minimum Annual Royalty as defined in this Section 8.2 will cease on [\*\*\*], if on such [\*\*\*] no patent has issued under the Patent Rights, and will not commence again until the [\*\*\*] in which the first patent under the Patent Rights issues.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3 In the event it becomes necessary for the Licensee or any Sublicensee to obtain a license to patent rights owned by an unaffiliated third party (defined as a third party which is not an Affiliate, Joint Venture, or further Sublicensee of the Licensee or of such Sublicensee) in order to make, have made, use, Sell, offer to Sell or import Licensed Products or Licensed Services, and Licensee or Sublicensee is required to pay a royalty to both The Regents under this Agreement and the unaffiliated third party under such separate license agreement in order to practice Licensed Methods and to make, have made, use, Sell, offer to Sell or import Licensed Products, then the Earned Royalty applicable hereunder may be reduced by the excess over [\*\*\*], including in such [\*\*\*] the relevant Earned Royalty payable under Section 8.1 at the time in question, [\*\*\*], provided that in no event will the Earned Royalty due to The Regents be reduced to less than [\*\*\*] of the amount due The Regents as specified in Section 8.1, in any given payment period. The Licensee, or, as relevant, a Sublicensee, may only reduce the Earned Royalty due to The Regents hereunder for licenses to patent rights owed to the same unaffiliated third party once, collectively among the Licensee and all Sublicensees, together. No reduction pursuant to this Section 8.3 will be available with respect to any Combined Product or Service if no such royalty would have been payable to such unaffiliated third party, who is not an Affiliate, Joint Venture, or sublicense of the Licensee or any Sublicensee, if the relevant Combination Component were not included in such Combined Product or Service.

9. MILESTONE PAYMENTS

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1 With respect to each [\*\*\*] Licensed Product, the Licensee will pay to The Regents the following amounts, which will be non-refundable and which may not be credited against any other amounts owed to The Regents by the Licensee under this Agreement (each a "<u>Milestone</u> <u>Payment</u>"):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.1 [\*\*\*];

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.2 [\*\*\*];

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.3 [\*\*\*];

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.4 [\*\*\*] upon [\*\*\*], with [\*\*\*];

------

**<u>Exhibit 10.19</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.5 [\*\*\*];

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.6 [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2 With respect to each [\*\*\*] Licensed Product, the Licensee will pay to The Regents the following amounts, which will be non-refundable and which may not be credited against any other amounts owed to The Regents by the Licensee under this Agreement:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.1 [\*\*\*];

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.2 [\*\*\*];

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.3 [\*\*\*];

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.4 [\*\*\*];

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.5 [\*\*\*];

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.6 [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3 Each of the Milestone Payments set forth in Section 9.1 and 9.2 will be payable with respect to only the first Licensed Product to achieve such milestone, regardless of whether such milestone is achieved by the Licensee, a Direct Sublicensee or a Secondary Sublicensee. Furthermore, each such Milestone Payment will be payable by the Licensee to The Regents regardless of whether the applicable milestone event has been achieved by the Licensee or by a Direct Sublicensee or Secondary Sublicensee.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.4 All Milestone Payments are due to The Regents within [\*\*\*].

10. DUE DILIGENCE

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1 From and after the Effective Date, the Licensee, during the term, of this Agreement, will diligently proceed with the development, manufacture and Sale of Licensed Products and Licensed Services and will earnestly and diligently market the same in quantities intended to be sufficient to meet the market demand therefor.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.2 The Licensee will obtain all necessary governmental approvals in each Country where Licensed Products and Licensed Services are manufactured, used, Sold, offered for Sale or imported by the Licensee.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.3 Subject to the provisions of Sections 10.6 and 10.7, the Licensee will complete the diligence milestones (each a "<u>Diligence Milestone</u>") set forth in Sections 10.4 and 10.5 by the date set forth in such Sections therefor, provided that [\*\*\*], and if [\*\*\*], then the [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.4 with respect to [\*\*\*] Licensed Products, and subject to the provisions of Sections 10.6 and 10.7, the Licensee will:

------

**<u>Exhibit 10.19</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.4.1 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.4.2 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.4.3 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.4.4 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.5 With respect to [\*\*\*] Licensed Products, and subject to the provisions of Sections 10.6 and 10.7, the Licensee will:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.5.1 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.5.2 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.5.3 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.5.4 [\*\*\*]

10.6 If the Licensee believes in good faith that it will be unable to timely complete the clinical development of any Licensed Product because the Licensee believes in good faith, after consultation with its regulatory advisors and/or with regulatory agencies, that there is the possibility of the existence of a safety or efficacy reason not to perform one or more of the steps necessary to allow the completion of such Licensed Product clinical development, then the Licensee will promptly consult with The Regents with respect to such determination, and the parties hereto will in good faith determine whether new Diligence Milestones for such Licensed Product or subsequent Licensed Products, are appropriate, and if The Regents, in its sole discretion, determines that such new Diligence Milestones are appropriate or necessary, the parties hereto will execute and deliver a written confirmation of such new Diligence Milestones, setting forth the new schedule for achievement of such Diligence Milestones within [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.7 If for any reason other than as provided in Section 10.6, the Licensee does not timely complete a Diligence Milestone set forth in Section 10.4 or 10.5, as relevant, The Regents will notify the Licensee in writing of such failure to perform by sending a Notice of Default, as set forth in Section 14, specifying the Diligence Milestone of the Licensee which The Regents believes the Licensee has failed to timely meet. The Licensee will have the right to extend the due date of such Diligence Milestone for a period of [\*\*\*] after the date of the failure to complete such Diligence Milestone, upon the payment by the Licensee to The Regents, within [\*\*\*], of an amount as follows, in each case in cash, (by the Licensee's check), accompanied by written notice from the Licensee to The Regents specifying the Diligence Milestone for which

------

**<u>Exhibit 10.19</u>**

the Licensee is paying for such extension, and setting forth in such notice the [\*\*\*] extended due date for such Diligence Milestone:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) [\*\*\*]

Upon the timely delivery to The Regents from the Licensee of such relevant payment and notice, the due date for the Diligence Milestone for the relevant Licensed Product as specified in such notice from the Licensee and for which payment has been so made by the Licensee to The Regents as provided herein, will be extended to a date which is [\*\*\*] after the relevant original due date therefor. The Licensee may, by complying with the notice and payment provisions of this Section 10.7, make an unlimited number of extensions to the original due date for such relevant Diligence Milestone. The extension payments provided above in this Section 10.7 will apply separately to each Diligence Milestone for a given Licensed Products, such that [\*\*\*]. The payments set forth in this Section 10.7 are in addition to any other payments required to be made by the Licensee to The Regents in this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.8 Upon any failure of the Licensee to meet the due date for a Diligence Milestone, after giving effect to any extension of such relevant due date as provided in Section 10.6 or 10.7, The Regents will have the right either to (a) terminate the License as to, or (b) to cause the License to become non-exclusive as to, in either case, all or any of the Patent Rights relevant solely to [\*\*\*] Licensed Product or [\*\*\*] Licensed Products as relevant, for which the relevant Diligence Milestone was not, after giving effect to the application of Sections 10.6 and 10.7, met, and which right in either case, if exercised by The Regents, supersedes and will control, as to the matters set forth in this Section 10.8, the rights of The Regents set forth in Article 2 and Article 14. Such right of The Regents to so terminate the License or to cause the License to become non-exclusive as to a given Licensed Product will be The Regents' sole remedy for any breach by the Licensee of the Licensee's obligations as to Diligence Milestone for such Licensed Product under, as relevant, Section 10.4 or 10.5. To exercise either the right to terminate the License or to cause the License to become non-exclusive to the relevant Licensed Product as described in this Section 10.8, The Regents will give the Licensee written notice of the relevant deficiency in a Notice of Default, as set forth in Article 14. The Licensee will have [\*\*\*], as set forth in Article 14, of such Notice of Default, to cure the deficiency described in such Notice of Default. If The Regents has not received written evidence satisfactory to The Regents that such deficiency

------

**<u>Exhibit 10.19</u>**

or deficiencies as specified in the Notice of Default have been cured or that steps acceptable to The Regents have been taken by the Licensee to cure such deficiency or deficiencies by the end of such [\*\*\*] period, then The Regents may, at its option, and solely as to the relevant Licensed Products to which such failure to meet the relevant Diligence Milestone applies, terminate the License immediately without the obligation to provide [\*\*\*] notice as set forth in Article 14, or may cause the License to become non-exclusive as to such Licensed Products, in either case by giving written notice to the Licensee (the "<u>Diligence Failure Action Notice</u>") of whichever of such determinations has been made by The Regents, and setting forth in such Diligence Failure Action Notice the effective date of such termination of the License or of such reduction of the License to non-exclusive status (specifying as to which Patent Rights and Licensed Products such termination or conversion to non-exclusive status has been made), which date of termination or conversion to non-exclusive status, as relevant, will not be prior to the date of such Diligence Failure Action Notice.

11. PROGRESS AND ROYALTY REPORTS

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.1 Beginning on [\*\*\*], the Licensee will submit to The Regents a written progress report as described in Section 11.2 covering the-Licensee's (and any Affiliates', Joint Venture's or Direct Sublicensee's or Secondary Sublicensee's) activities related to the development of Licensed Products and Licensed Services, the status of obtaining of the governmental approvals necessary for marketing Licensed Products and Licensed Services, and other activities undertaken in order to meet the diligence requirements set forth in Article 10, as further set forth under Section 11.2. Such progress reports will be required for each Licensed Product and Licensed Service, including with respect to any Exploitation of any Licensed Product and/or Licensed Service, as relevant, until the date the first Sale of such Licensed Product or Licensed Service occurs in the United States and will be again required if, and for so long as, all Sales and Exploitation of such Licensed Product or Licensed Service are suspended or discontinued in any Country during the term of this Agreement.

11.2 Progress reports submitted under Section 11.1 will include, but are not limited to, a detailed summary of the following topics so that The Regents will be able to determine the progress of the development of Licensed Products and Licensed Services and will also be able to determine whether or not the Licensee has met its diligence obligations set forth in Article 10:

------

**<u>Exhibit 10.19</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.2.1 A summary of development activities completed by the Licensee pursuant to the Patent Rights License and the Technology Rights License ("development activities") as of the submission date of the progress report;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.2.2 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.2.3 A summary of development activities in progress by the Licensee as of the submission date of the progress report;

11.2.4 A current schedule of relevant events and milestones in connection with the development activities of the Licensee, including events and milestones specified in Article 10,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.2.5 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.2.6 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.2.7 Information as to each Sublicensee relating to the items in Sections 11.2.1 through 11.2.5, as if such Sublicensee were Licensee, if there are any Sublicensees at the time of the relevant progress report.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.3 [\*\*\*]. If either party terminates this Agreement before any Licensed Products or Licensed Services are Sold, or before the expiration of this Agreement, then a final progress report covering the period prior to termination must be submitted by the Licensee to The Regents within [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.4 The Licensee will keep The Regents informed on at least [\*\*\*] basis, with each [\*\*\*] period running from the Effective Date and thereafter serially, or more frequently as may be required by law or as may be requested in good faith by The Regents in writing to the Licensee, of the business entity status (small business entity status or large business entity status as defined by the United States Patent and Trademark Office) of the Licensee and of any Affiliates, Joint Ventures, or Sublicensees. The Licensee will notify The Regents of any change of the Licensee's status or that of any Affiliate, Joint Venture, or Sublicensee, as a small business entity or large business entity, as defined by the United States Patent and Trademark Office, within [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.5 The Licensee will report to The Regents the date of first Sale, or Exploitation as provided in Section 1.36 with respect to preclinical trials, clinical trials, and certain disposition by not-for-profit foundations and other not-for-profit organizations, of a Licensed Product or

------

**<u>Exhibit 10.19</u>**

Licensed Service in each Country in the Licensee's first progress report and royalty report following such date of first Sale or Exploitation of a Licensed Product or Licensed Service.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.6 Beginning with [\*\*\*], the Licensee will make [\*\*\*] reports to The Regents, as to Earned Royalties due from, and Sublicensing Revenues of, the Licensee, on or before each [\*\*\*]. Each such report will cover Licensee's most recently completed [\*\*\*] and will, at a minimum, show:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.6.1 the Gross Invoice Prices and Net Sales of Licensed Products or Licensed Services Sold or Exploited [\*\*\*], any Sublicensing Revenues [\*\*\*] due to the Licensee;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.6.2 the quantity of each type of Licensed Product and/or Licensed Service which has been Sold or Exploited;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.6.3 the Country in which each Licensed Product and Licensed Service was made, used or Sold or Exploited;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.6.4 the amount of Earned Royalties, in dollars, payable by the Licensee to The Regents with respect to Net Sales and Service Income for such period;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.6.5 the amount of Sublicensing Revenues Fees, in dollars, payable by the Licensee to The Regents with respect to Sublicensing Revenues for such period;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.6.6 the method used by the Licensee to calculate the Earned Royalties, specifying the nature of all Deductions taken from Net Sales and the dollar amount of each such Deduction;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.6.7 currency exchange rates used, if any;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.6.8 the amount of the cash, and the amount of the cash equivalent of any non-cash consideration, within Net Sales, including the method used to calculate such non-cash consideration;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.6.9 [\*\*\*]; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.6.10 any other information reasonably necessary to confirm the Licensee's calculation of its financial obligations hereunder to make payments to The Regents as provided in this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.7 If during any reporting period no Sales of Licensed Products and Licensed Services have been made and no Licensed Products or Licensed Services have been Exploited

------

**<u>Exhibit 10.19</u>**

and no Earned Royalties or Sublicensing Revenues are due to The Regents, then a statement to this effect will be provided by the Licensee in the Licensee's written report to The Regents for such period.

12. BOOKS AND RECORDS

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.1 The Licensee will keep accurate books and records showing all Licensed Products under development, manufactured, used, offered for Sale, imported, Sold and or otherwise Exploited; all Licensed Service Sold or otherwise provided; all Net Sales, all Sublicensing Revenues, all Service Income and other amounts payable hereunder; and all sublicenses granted under the terms of this Agreement. Such books and records will be preserved for [\*\*\*] and will be open to inspection by representatives or agents of The Regents during regular business hours and upon reasonable advance written notice, to determine their accuracy and assess the Licensee's compliance with the terms of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2 The Regents will pay the fees and expenses of such examination, provided that if an error in payment due from the Licensee to The Regents of more than [\*\*\*] of the amount due for any year, from the Licensee to The Regents, is discovered in any such examination, then the Licensee will bear the fees and expenses of such examination and will remit such underpayment to The Regents within [\*\*\*]. The Regents will provide the Licensee with a correct and complete copy of the final results of any such examination.

13. TERM OF THIS AGREEMENT

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.1 Unless otherwise terminated by operation of law, Section 13.2, or by acts of the parties hereto in accordance with the terms of this Agreement, this Agreement will remain in effect from the Effective Date until the expiration or abandonment of the last of the Patent Rights licensed hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.2 This Agreement will automatically terminate without the obligation to provide [\*\*\*] notice as set forth in Article 14, upon the filing of a petition for relief under the United States Bankruptcy Code by or against the Licensee as a debtor or alleged debtor.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.3 Any expiration or termination of this Agreement will not affect the rights and obligations of the parties set forth in the following Articles and Sections:

Article 1 Definitions

Section 4.7 Late Payments

Article 5 License Issue Fee

------

**<u>Exhibit 10.19</u>**

Article 7 Sublicensing Revenues Fee

Article 8 Earned Royalties and Minimum Annual Royalties

Article 12 Books and Records

Article 13 Term of This Agreement

Article 16 Disposition of Licensed Products and Licensed Services Upon Termination or Expiration

Article 17 Use of Names and Trademarks

Article 18 Limited Warranty

Article 19 Limitation of Liability

Sections 20.4 and 20.6 Patent Prosecution and Maintenance

Article 23 Indemnification

Article 24 Notices; Payments

Article 28 Governing Laws; Venue; Attorneys Fees

Article 31 Confidentiality

Section 32.6 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.4 The expiration or termination of this Agreement will not relieve the Licensee of its obligation to pay any fees, royalties or other payments which are due and owed to The Regents under this Agreement at the time of such expiration or termination and will not impair any accrued right of The Regents, including the right to receive Earned Royalties in accordance with Articles 7, 8 and 16.

14. TERMINATION BY THE REGENTS

In addition to the rights of The Regents to terminate this Agreement as set forth under [\*\*\*], if the Licensee fails to perform, or violates, any other term or covenant of this Agreement applicable to the Licensee, then The Regents may give written notice or such default (a "<u>Notice of Default</u>") to the Licensee, specifying therein such claimed failure or violation. The Regents may terminate the License as to all, or, at the election of The Regents, some but not all, of the Patent Rights, as such determination will be set forth in the Notice of Termination For Uncured Default, as next defined. If the Licensee fails to cure such default within [\*\*\*], and if The Regents has not waived such default in writing, The Regents will have the right to immediately terminate this Agreement and the License by providing written notice of termination thereof to the Licensee (the "<u>Notice</u> <u>of Termination for Uncured Default</u>"), specifying therein (a) the date

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**<u>Exhibit 10.19</u>**

of such termination, which will not be prior to the date of the Notice of Termination For Uncured Default, and (b) whether such termination is as to all of the Patent Rights, or, as to which Patent Rights such termination is effective if not as to all of the Patent Rights.

15. TERMINATION BY LICENSEE

The Licensee may terminate this Agreement at any time by providing written notice of termination to The Regents. The Licensee also will be entitled to terminate the License as to specific Patent Rights included within the License on a Country-by-Country basis by giving notice in writing to The Regents of the effective date of such termination and referring specifically to the Patent Rights as to which the Licensee is so terminating the License; any such termination as to specific Patent Rights will not affect the rights of the Licensee as to any other Patent Rights nor otherwise as to the License, [\*\*\*]. Any such termination of this Agreement (but not termination of any patents or patent applications under the Patent Rights, which termination is subject to Section 20.6) will be effective [\*\*\*], or on such earlier or later date as the Licensee and The Regents may agree in writing.

16. DISPOSITION OF LICENSED PRODUCTS AND LICENSED SERVICES UPON TERMINATION OR EXPIRATION

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;16.1 Upon termination (but not expiration) of this Agreement, within a period of [\*\*\*], the Licensee is entitled to (a) dispose of all previously made or partially made Licensed Product, but no more and (b) provide previously contracted-for Licensed Services, provided that the Sale or use of such Licensed Product and the provision of such Licensed Services are subject to the terms of this Agreement, including, but not limited to, the rendering of reports and payment of Earned Royalties, Sublicensing Revenues Fees and any other payments therefore required under this Agreement. The Licensee may not otherwise make, have made, Sell, offer for Sale or import Licensed Products or Licensed Services, or practice the Licensed Method after the date of termination.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;16.2 If applicable Patent Rights exist at the time of any making, Sale, offer for Sale, or import of a Licensed Product or the time of any Sale, offer for Sale, or rendering of a Licensed Service, then Earned Royalties will be paid at the times provided herein and royalty reports will be rendered in connection therewith, notwithstanding the absence of applicable Patent Rights with respect to such Licensed Product or Licensed Service at any later time. Otherwise, no Earned Royalties will be paid on the Sales of such Product or Service. Any fees or other

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**<u>Exhibit 10.19</u>**

payments owed to The Regents at the time of expiration or termination not based on the Sales of a Licensed Product or Licensed Service will be paid to The Regents at the time such fee or other payment would have been due had this Agreement not expired or been terminated.

17. USE OF NAMES AND TRADEMARKS

Nothing contained in this Agreement will be construed as conferring any right to either party to use in advertising, publicity or other promotional activities any name, trade name, trademark or other designation of the other party (including a contraction, abbreviation or simulation of any of the foregoing). Without the Licensee's prior consent on a case by case basis, The Regents may list Licensee's name as a licensee of technology from The Regents without further identifying the technology. Unless required by law or unless consented to in writing by Director, Office of Technology Management of The Regents, the use by the Licensee of the name "The Regents of the University of California" or the name of any campus of the University of California in advertising, publicity or other promotional activities is expressly prohibited. Licensee may not use the name of HHMI or of any HHMI employee (including [\*\*\*]) in a manner that reasonably could constitute an endorsement of a commercial Product or Service; but that use for other purposes, even if commercially motivated, is permitted provided that (1) the use is limited to accurately reporting factual events or occurrences, and (2) any reference to the name of HHMI or any HHMI employees in press releases or similar materials intended for public release is approved by HHMI in advance.

18. LIMITED WARRANTY

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.1 The Regents warrants to the Licensee that it has the lawful right to grant the License.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.2 Except as expressly set forth in this Agreement, the License and the associated Invention, Patent Rights, Licensed Products, Licensed Services, Licensed Methods and any Original Materials and Biological Materials, as relevant, are provided by The Regents WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY Of ANY KIND, EXPRESS OR IMPLIED. THE REGENTS MAKES NO EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY THAT THE INVENTION, PATENT RIGHTS, LICENSED PRODUCTS, LICENSED SERVICES, LICENSED METHODS, BIOLOGICAL MATERIALS, OR ORIGINAL

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**<u>Exhibit 10.19</u>**

MATERIALS WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK OR OTHER RIGHTS.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.3 This Agreement does not:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.3.1 express or imply a warranty or representation as to the validity, enforceability, or scope of any Patent Rights or Technology Rights; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.3.2 express or imply a warranty or representation that anything made, used, Sold, offered for Sale or imported or otherwise Exploited under any license granted in this Agreement is or will be free from infringement of patents, copyrights, trademarks or other rights of third parties; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.3.3 obligate The Regents to bring or prosecute actions against third parties for patent infringement except as provided in Article 22; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.3.4 confer by implication, estoppel or otherwise any license or rights under any patents or other rights of The Regents other than the Patent Rights, regardless of whether such patents are dominant or subordinate to the Patent Rights; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.3.5 obligate The Regents to furnish any New Developments, know-how, technology or information not provided in the Patent Rights or Technology Rights; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.3.6 obligate The Regents to update the technology in the Technology Rights.

19. LIMITATION OF LIABILITY

THE REGENTS WILL NOT BE LIABLE FOR ANY LOST PROFITS, COSTS OF PROCURING SUBSTITUTE GOODS OR SERVICES, LOST BUSINESS, ENHANCED DAMAGES FOR INTELLECTUAL PROPERTY INFRINGEMENT OR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR OTHER SPECIAL DAMAGES SUFFERED BY LICENSEE, SUBLICENSEES, JOINT VENTURES OR AFFILIATES ARISING OUT OF OR RELATED TO THIS AGREEMENT FOR ALL CAUSES OF ACTION OF ANY KIND (INCLUDING TORT, CONTRACT, NEGLIGENCE, STRICT LIABILITY AND BREACH OF WARRANTY) EVEN IF THE REGENTS HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

20. PATENT PROSECUTION AND MAINTENANCE

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**<u>Exhibit 10.19</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20.1 As long as [\*\*\*] as provided for in this Article 20, The Regents will diligently prosecute and maintain the United States and foreign patents comprising the Patent Rights using legal counsel of its choice. The Regents' legal counsel will take instructions only from The Regents. The Regents will provide the Licensee with copies of all relevant documentation so that the Licensee will be informed of the continuing prosecution and may comment upon such documentation sufficiently in advance of any initial deadline for filing a response, provided, however, that if the Licensee has not commented upon such documentation in a reasonable time for The Regents to sufficiently consider the Licensee's comments prior to a deadline with the relevant government patent office, or The Regents must act to preserve the Patent Rights, The Regents will be free to respond without consideration of the Licensee's comments, if any. The Licensee will keep such documentation confidential as provided in Article 31.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20.2 The Regents will use its reasonable efforts to amend any patent application to include claims reasonably requested in writing by the Licensee to protect the Licensed Products and Licensed Services contemplated by the Licensee to be Sold, or the Licensed Method to be practiced, under this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20.3 The Licensee will apply for an extension of the term of any patent included within the Patent Rights if appropriate under the Drug Price Competition and Patent Term Restoration Act of 1984 and/or European, Japanese and other foreign counterparts of such law. The Licensee will prepare all documents, and The Regents will execute such documents and will assist the Licensee with reasonable requests, in connection therewith. [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20.4 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20.5 The Licensee may request that The Regents obtain patent protection on the Invention in foreign Countries, if such patent protection is available in the requested foreign Country or Countries. The Licensee will notify The Regents in writing of the Licensee's desire that The Regents obtain or maintain any such patent(s) in the relevant foreign Country or Countries, not less than [\*\*\*], filing or action to be taken in connection with any such filing. Such notice concerning any foreign filing must be in writing, must identify the Country or Countries desired and the relevant patent(s) for which such filing is desired by the Licensee, and [\*\*\*]. The absence of timely delivery hereunder of such notice from the Licensee to The Regents as to any patent in the relevant foreign Country or Countries will be considered an

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**<u>Exhibit 10.19</u>**

election by the Licensee not to obtain or maintain Patent Rights as to such patent(as) in such relevant foreign Country or Countries.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20.6 [\*\*\*]. The Licensee may terminate its obligation hereunder [\*\*\*] with respect to any given patent application or patent under the Patent Rights in any or all Countries stated in a written notice by the Licensee to The Regents with respect thereto, which must be given to The Regents by the Licensee upon at least [\*\*\*] written notice prior to the date desired by the Licensee for such termination of [\*\*\*]. The Regents may continue prosecution and/or maintenance of such application(s) or patent(s) at The Regents' sole discretion [\*\*\*], provided, however, that the Licensee will have no further right or licenses hereunder with respect to such, as relevant, application(s) or patent(s). The failure of the Licensee to [\*\*\*] may be deemed by The Regents as an election by the Licensee not to maintain such application(s) or patent(s), and The Regents will give the Licensee written notice of any such determination within [\*\*\*] after such determination has been made by The Regents.]-

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20.7 The Regents may file, prosecute or maintain patent applications or patents [\*\*\*] in any Country in which the Licensee has not elected to file, prosecute or maintain patent applications or patents in accordance with this Article 20 and those applications and all patents resulting therefrom will not be subject to this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20.8 If The Regents decides not to file a patent application, which Licensee has requested be filed under this Agreement, or if The Regents decides to discontinue the prosecution or maintenance of any such patent application or patent, which Licensee has requested be prosecuted or maintained under this Agreement, The Regents will notify the Licensee in writing with respect thereto within [\*\*\*] and will, upon Licensee's written request, reasonably discuss with Licensee such decision and alternatives to abandonment of the relevant patent or, as relevant, to such decision to not file or pursue such relevant patent application.

21. PATENT MARKING

The Licensee will mark all Licensed Products made, used or Sold under the terms of this Agreement, or the containers for such Licensed Products, in accordance with applicable patent marking laws.

22. PATENT INFRINGEMENT

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.1 If The Regents (to the extent of the actual knowledge of the licensing professional within UCSF responsible for the administration of this Agreement), or the Licensee, learns of

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**<u>Exhibit 10.19</u>**

infringement or potential infringement of any Patent Rights licensed under this Agreement, the party gaining such knowledge will provide the other party as promptly as possible after becoming aware of such infringement or potential infringement (i) with written notice of such infringement or potential infringement and (ii) with any evidence of such infringement or potential infringement available to the notifying party (an" <u>Infringement Notice</u>"). During the period in which, and in the jurisdiction(s) in which, the Licensee has exclusive rights under the Patent Rights License as to the relevant patent(s) which are being infringed or potentially infringed [neither The Regents nor the Licensee will, after becoming aware of any such infringement or potential infringement, notify the relevant infringer(s) or possible infringer(s) of such infringement or potential infringement, nor put such infringer(s) or possible infringer(s) on notice of the existence of any Patent Rights, without in each case first obtaining the written consent of the other party hereto to making such notification. If the Licensee puts such infringer(s) or possible infringer(s) on notice of the existence of any Patent Rights with respect to such infringement or potential infringement without first obtaining the written consent of The Regents for the giving of such notice, and if a declaratory judgment action then is filed by such infringer(s) or potential infringer(s) against The Regents, Licensee's right to initiate an action against such infringer(s) or possible infringer(s) for infringement or potential infringement under Section 22.2 will terminate immediately without the obligation of The Regents to provide notice to the Licensee. The Regents and the Licensee will use their [\*\*\*] efforts to cooperate with each other to cause such infringement or potential infringement to cease and terminate without litigation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.2 If the relevant infringing or potentially infringing activity by the infringer(s) or possible infringers(s) has not ceased within [\*\*\*], the Licensee may institute an action for patent infringement against the infringer(s) or possible infringer(s). The Regents may voluntarily join such action at The Regents' expense, but may not thereafter commence an action against the infringer(s) or possible infringer(s) for the acts of infringement or potential infringement that are the subject of the Licensee's action or of any judgment rendered in such action. The Licensee may not, without The Regents' prior written consent, join The Regents as a party in any action initiated by the Licensee, pursuant to the Licensee's rights under this Agreement to initiate such action, for infringement or potential infringement. If, in any such action initiated by the Licensee as permitted hereunder, The Regents is involuntarily joined other than by the Licensee, [\*\*\*].

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**<u>Exhibit 10.19</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.3 If, within [\*\*\*], infringing activity by the infringer(s), or as relevant potential infringing activity by the possible infringer(s), has not ceased and if the Licensee has not brought an action against the infringer, The Regents may institute an action against the infringer(s) for patent infringement or an appropriate action against the possible infringer(s). If The Regents institutes such action, the Licensee may not join such action without The Regents' consent and the Licensee may not thereafter commence an action against the infringer(s) for the acts of infringement, or against the possible infringer(s), that are the subject of The Regents' action, or any judgment rendered in such action.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.4 Notwithstanding anything to the contrary in this Agreement, in the event that the relevant infringement or potential infringement pertains to an issued patent included within the Patent Rights and written notice is given under the Drug Price Competition and Patent Term Restoration Act of 1984 (and/or foreign counterparts of this Law), then the party hereto in receipt of such notice under the Act will provide the Infringement Notice to the other party hereto promptly. If the time period is such that the Licensee will lose the right to pursue a legal remedy for infringement by not notifying a third party or by not filing an action, the notification period and the time period to file such action will be accelerated to be within [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.5 Any recovery or settlement received in connection with any action will [\*\*\*]. In any action initiated by the Licensee, any recovery in excess of litigation costs will [\*\*\*]. In any action initiated by The Regents, any recovery in excess of the litigation costs of The Regents and, as applicable, the Licensee, will [\*\*\*]. The Regents and the Licensee will be bound by all determinations of patent infringement, validity and enforceability (but no other issue) resolved by any adjudicated judgment not subject to further appeal, in any action brought in compliance with this Article 22.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.6 Any agreement made by the Licensee with any party for purposes of settling litigation or any other dispute with respect to any of the rights licensed to the Licensee under this Agreement will comply with the requirements of Article 3.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.7 Each party will cooperate with the other in any proceedings in any action instituted hereunder [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.8 Any proceedings of any action instituted hereunder will be controlled by the party bringing the action, except that The Regents may be represented by legal counsel of The Regents' choice in any action brought by the Licensee.

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**<u>Exhibit 10.19</u>**

23. INDEMNIFICATION

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;23.1 The Licensee will, and will require its Sublicensees to, indemnify, hold harmless and defend The Regents and its officers, employees and agents, the sponsors of the research that led to the Invention and the development of the Original Materials, and the inventors of the Original Materials and any invention claimed in patents or parent applications under the Patent Rights (including the Licensed Products, Licensed Services and Licensed Methods contemplated thereunder) and their employers against any and all claims, actions, losses, damage, costs, fees and expenses resulting from, or arising out of, the exercise of this license or any sublicense. This indemnification will include, but not be limited to, any Product liability claims. If The Regents, in its sole discretion, believes that there will be a conflict of interest or it will not otherwise be adequately represented by legal counsel chosen by the Licensee to defend The Regents in accordance with this Section 23.1, then The Regents may retain legal counsel of its choice to represent it [\*\*\*]. HHMI and its trustees, officers, employees, and agents (collectively, "<u>HHMI Indemnitees</u>") will be indemnified, defended by counsel acceptable to HHMI, and held harmless by the Licensee and any Sublicensees from and against any claim, liability, cost, expense, damage, deficiency, loss, or obligation of any kind or nature (including, without limitation, reasonable attorneys' fees and other costs and expenses of defense) based on, resulting from, arising out of, or otherwise relating to this Agreement or the exercise of this License or any sublicense, including without limitation a cause of action relating to product liability (collectively, "<u>Claims</u>"). The previous sentence will not apply to any Claim that is determined with finality by a court of competent jurisdiction to result solely from the gross negligence or willful misconduct of an HHMI Indemnitee. Licensee's indemnification obligation set forth above shall not apply to any claim, liability, cost, expense, damage, deficiency, loss, or obligation of any kind or nature (including, without limitation, reasonable attorneys' fees and other costs and expenses of defense) resulting from any claim, demand or suit between The Regents and HHMI. For clarity, acts conducted under the retained rights and licenses of The Regents and HHMI and the United States Government as set forth in Sections 2.2 and 2.3 are not subject to this indemnification obligation of the Licensee or any Sublicensee. If HHMI reasonably believes that there will be a conflict of interest in the Licensee's defense of such Claims, then HHMI may retain legal counsel of HHMI's choice to represent the HHMI Indemnitees, [\*\*\*].

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**<u>Exhibit 10.19</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;23.2 During the term of this Agreement and for [\*\*\*], the Licensee, [\*\*\*], will insure its activities in connection with any work performed by the Licensee pursuant to this Agreement, and in such regard will maintain at least the following insurance, or an equivalent program of self-insurance:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;23.2.1 Comprehensive or commercial form general liability insurance (contractual liability included) with limits as follows:

[\*\*\*]

[\*\*\*]

[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;23.2 Notwithstanding the above, no later than the earlier of: i) [\*\*\*]; or ii) [\*\*\*], Licensee, [\*\*\*], will insure its activities in connection with any work performed by the Licensee pursuant to this Agreement, and in such regard will maintain at least the following insurance (or an equivalent program of self-insurance) during the term of this Agreement and for [\*\*\*]:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;23.3.1 Comprehensive or Commercial Form General Liability Insurance (contractual liability included) with limits as follows in force by the date specified below:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;23.3.2 The coverage and limits referred to in Section 23.2.1 and 23.3.1 will not in any way limit the liability of the Licensee hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;23.3.3 The Licensee will furnish The Regents with certificates of insurance evidencing compliance with all requirements therefor hereunder. Such certificates will:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Provide for at least [\*\*\*] advance written notice to The Regents of any modification;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) Include a provision that the coverage will be primary and will not participate with, nor will be excess over, any valid and collectable insurance or program of self-insurance maintained by The Regents or HHMI.

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**<u>Exhibit 10.19</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;23.4 The Regents will promptly notify the Licensee in writing of any claim or action brought against The Regents for which The Regents intends to invoke the provisions of this Article 23. The Licensee will keep The Regents informed of the Licensee's defense of any Claims pursuant to this Article 23. In the case of an HHMI Indemnitee, written notice will be given reasonably promptly following actual receipt of written notice thereof by an officer or attorney of HHMI. Notwithstanding the foregoing, the delay or failure of an HHMI Indemnitee to give prompt written notice to the Licensee of any Claim will not affect the rights of such HHMI Indemnitee hereunder unless, and then only to the extent that, such delay or failure is prejudicial to or otherwise adversely affects the Licensee. The Licensee will keep HHMI informed as to the Licensee's defense of any Claims pursuant to this Article 23.

24. NOTICES; PAYMENTS

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;24.1 Any notice required to be given under this Agreement will be in writing and will be deemed to have been properly given and to be effective as of the date specified below if delivered to the respective address given below or to another address as designated by written notice given to the other party in accordance with this Section 24.1:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;24.1.1 on the date of delivery if delivered in person;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;24.1.2 on the date of mailing if mailed by first-class certified mail, postage paid; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;24.1.3 on the date of mailing if mailed by any global express carrier service, such as but not limited to FedEx or DHL, that requires the recipient to sign a document demonstrating the delivery of such notice or payment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;24.1.4 on the date of transmission by facsimile or by electronic mail (email) without failure of transmission, if delivered by the Regents to the Licensee's facsimile number or email address below or to another facsimile number or email address for Licensee as designated by written notice given by the Licensee to The Regents in accordance with this Section 24.1:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) In the case of Licensee:

Intellikine, Inc.

575 Old Mill Road

San Marino, CA 91108

Attention: [\*\*\*]

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**<u>Exhibit 10.19</u>**

Facsimile: 626-403-2560

Email: [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) In the case of The Regents, in each case referring to UC Case Nos. [\*\*\*]:

The Regents of the University of California

Office of Technology Management

Attention: [\*\*\*]

185 Berry Street, Suite 4603

San Francisco, CA 94107

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;24.2 Payments to The Regents due under this Agreement must be directed to the following address, in each case referring to UC Case Nos. [\*\*\*], as relevant:

Office of Technology Transfer

Attn.: [\*\*\*]

University of California

Office of the President

1111 Franklin Street, 5<sup>th</sup> Floor

Oakland, CA 94607-5200

25. ASSIGNABILITY

This Agreement is personal to the Licensee. The Licensee may not assign or transfer this Agreement, including by merger, operation of law, or otherwise, without The Regents' prior written consent, except that such consent will not be required in the case of assignment or transfer to a party that succeeds to all or substantially all of Licensee's business or assets relating to this Agreement, whether by sale, merger, operation of law or otherwise, provided that such assignee or transferee promptly agrees to be bound by the terms and conditions of this Agreement and signs The Regents' standard substitution of party letter (the form of which is attached hereto as Appendix B). Any attempted assignment by the Licensee in violation of this Article 25 will be null and void. This Agreement is binding upon and will inure to the benefit of The Regents and its successors and assigns, and the Licensee and its successors and permitted assigns.

**<br> 26. WAIVER

No waiver by either party of any breach or default of any of the covenants or agreements contained herein will be deemed a waiver as to any subsequent and/or similar breach or default. No waiver will be valid or binding upon the parties hereto unless made in writing and signed by a duly authorized officer of each party.

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**<u>Exhibit 10.19</u>**

27. FORCE MAJEURE

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;27.1 Except for the Licensee's obligation to make any payments to The Regents hereunder, the parties hereto will not be responsible for any failure to perform due to the occurrence of any events beyond their reasonable control which render their performance impossible or onerous, including, but not limited to: accidents (environmental, toxic spill, etc.); acts of God; biological or nuclear incidents; casualties; earthquakes; fires; floods; governmental acts; orders or restrictions; inability to obtain suitable and sufficient labor, transportation, fuel and materials; local, national or state emergency; power failure and power outages; acts of terrorism; strike; and war.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;27.2 Either party to this Agreement, however, will have the right to terminate this Agreement upon [\*\*\*] prior written notice if either party is unable to fulfill its obligations under this Agreement due to any of the causes specified in Section 27.1 for a period of [\*\*\*].

28. GOVERNING LAWS; VENUE; ATTORNEYS FEES

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;28.1 This Agreement will be interpreted and construed in accordance with the laws of the State of California, excluding any choice of law rules that would direct the application of the laws of another jurisdiction and without regard to which party drafted particular provisions of this Agreement, provided that the scope and validity of any patent or patent application will be governed by the applicable laws of the relevant Country in which such patent is issued or in which such patent application has been made as to which such dispute has arisen.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;28.2 Any legal action brought by the parties hereto relating to this Agreement will be conducted in San Francisco, California, and the parties hereto hereby consent to the <u>in</u> <u>personam</u> jurisdiction of, and venue in, the federal and State courts located therein.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;28.3 [\*\*\*]

29. GOVERNEMENT APPROVAL OR REGISTRATION

If this Agreement or any associated transaction is required by the law of any nation to be either approved or registered with any governmental agency, the Licensee will assume all legal obligations to do so. Each party hereto will notify the other party hereto in writing if the first party becomes aware that this Agreement is subject to a United States or foreign government reporting or approval requirement. The Licensee will make all necessary filings [\*\*\*] associated with such reporting or approval process.

30. COMPLIANCE WITH LAWS

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**<u>Exhibit 10.19</u>**

The Licensee will comply with all applicable international, national, state, regional and local laws and regulations in performing its obligations hereunder and in its use, manufacture, Sale or import of the Licensed Products, Licensed Services or practice of the Licensed Method. The Licensee will observe all applicable United States and foreign laws with respect to the transfer of Licensed Products and related technical data and the provision of Licensed Services to foreign Countries, including, without limitation, the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations. The Licensee will manufacture Licensed Products and practice the Licensed Method in compliance with applicable government importation laws and regulations of a particular Country for Licensed Products made outside the particular Country in which such Licensed Products are used, Sold or otherwise exploited.

31. CONFIDENTIALITY

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;31.1 The Licensee and The Regents will treat and maintain the other party's proprietary or confidential information, including without limitation the other party's business, patent prosecution and other intellectual property, software, engineering drawings, process and technical information and other proprietary information, including the terms of this Agreement and any reports and documents to be delivered pursuant to this Agreement (collectively, the relevant party's "<u>Proprietary Information</u>") in confidence using at least the same degree of care as the receiving party uses to protect its own proprietary information of a like nature, from the date of disclosure until [\*\*\*]. This confidentiality obligation will apply to the information defined as "Data" under the Secrecy Agreement and such Data will be treated as Proprietary Information hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;31.2 The Licensee and The Regents may use and disclose Proprietary Information to their employees, agents, consultants, contractors and, in the case of the Licensee, its Direct Sublicensees, provided that such parties hereto are bound by a like duty of confidentiality as that found in this Article 31. Notwithstanding anything to the contrary contained in this Agreement, The Regents may release this Agreement, including any terms contained herein and information regarding royalty payments or other income received in connection with this Agreement to the inventors, senior administrative officials employed by The Regents and individual Regents and to the senior administrative officials employed by HHMI and the individual trustees of HHMI upon their request. If such release is made, The Regents will request that such terms be kept in confidence in accordance with the provisions of this Article 31. In addition, notwithstanding

------

**<u>Exhibit 10.19</u>**

anything to the contrary in this Agreement, if a third party inquires whether a license to the Patent Rights is available, then The Regents may disclose the existence of this Agreement and the extent of the grant in Articles 2 and 3 and related definitions to such third party, but will not disclose the name of the Licensee unless Licensee has already made such disclosure publicly.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;31.3 All written Proprietary Information will be labeled or marked confidential or proprietary. If the Proprietary Information is initially orally disclosed, it will be reduced to writing or some other physically tangible form, marked and labeled as confidential or proprietary by the disclosing party and delivered to the receiving party within [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;31.4 Nothing contained herein will in any way restrict or impair the right of the Licensee or The Regents, as the recipient party, to use or disclose any Proprietary Information of the disclosing party:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;31.4.1 that the recipient party can demonstrate by written records was previously known to it prior to its disclosure by the disclosing party to the recipient party;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;31.4.2 that the recipient party can demonstrate by written records is now, or becomes in the future, public knowledge other than through acts or omissions of the recipient party;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;31.4.3 that the recipient party can demonstrate by written records was lawfully obtained without restrictions on the recipient party, from sources independent of the disclosing party; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;31.4.4 that the recipient party is required to disclose pursuant to the California Public Records Act or other applicable law.

The Licensee or The Regents also may use or disclose Proprietary Information that is required to be disclosed (i) to a governmental entity or agency in connection with seeking any governmental or regulatory approval, governmental audit, or other governmental contractual requirement or (ii)

by law, provided that the recipient uses reasonable efforts to give the party owning the Proprietary Information sufficient written notice of such required disclosure to allow the party owning the Proprietary Information reasonable opportunity to object to, and to take legal action to prevent or limit, such disclosure.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;31.5 The Licensee and The Regents will, within [\*\*\*] following the expiration or termination of this Agreement, destroy or return to the other party any of the disclosing party's

------

**<u>Exhibit 10.19</u>**

Proprietary Information in the relevant recipient party's possession on the date of such expiration or termination, provided that each party may retain one copy of such Proprietary Information of the other party for archival purposes, which retained Proprietary Information will, until destroyed or returned to the other party, remain subject to the provisions of this Article 31. The Licensee and The Regents will provide each other, within [\*\*\*] following expiration or termination of this Agreement, with written notice that such Proprietary Information has been so returned or destroyed, subject to the right of the notifying party to retain an archival copy thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;31.6 With regard to biological material received by the Licensee from The Regents, if any, under this Agreement, including without limitation any cell lines, vectors, genetic material, derivatives, Products, progeny or material in each case derived therefrom ("<u>Biological</u> <u>Material</u>"), the Licensee:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;31.6.1 Will not use Biological Material except for the sole purpose of performing under the terms of this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;31.6.2 Will not transfer Biological Material to others (except to its employees, agents or consultants who are bound to the Licensee by like obligations conditioning and restricting access, use and continued use of Biological Material) without the express written permission of The Regents, except that the Licensee is not prevented from transferring any biological material that is lawfully obtained by the Licensee from sources independent of The Regents;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;31.6.3 Will safeguard Biological Material against disclosure and transmission to others with the same degree of care as the Licensee exercises with its own biological materials of a similar nature; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;31.6.4 Will destroy all copies of Biological Material within [\*\*\*] following the effective date of the expiration or termination of this Agreement.

32. MISCELLANEOUS

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;32.1 The headings of the Articles and Sections herein are for convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement.

------

**<u>Exhibit 10.19</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;32.2 This Agreement will be binding on the parties hereto as of the Effective Date when it has been signed hy each party. This Agreement may be signed in counterparts, each of which will be an original and both of which together will constitute the same instrument.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;32.3 No amendment or modification of this Agreement will be valid or binding on the parties hereto unless made in writing and signed by each party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;32.4 This Agreement, including Appendices A, B and C, each of which is incorporated herein by reference, sets forth the entire understanding of the parties hereto with respect to the specific subject matter hereof, and supersedes in their entirety all previous communications, representations or understandings or agreements, whether oral or written, between the parties hereto relating to the specific subject matter hereof. The Secrecy Agreement dated [\*\*\*] and the Letter of Intent dated [\*\*\*] in each case between The Regents and the Licensee are hereby terminated as of the Effective Date, provided that the provisions of the Secrecy Agreement and the Letter of Intent will survive as to any breach by either party thereof which may have occurred prior to the Effective Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;32.5 If any provision contained in this Agreement is held to be invalid, illegal or unenforceable in any respect by a court of competent jurisdiction, such invalidity, illegality or unenforceability will not affect any other provisions of this Agreement and this Agreement will be construed as if such invalid, illegal or unenforceable provision had never been contained in this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;32.6 No provisions of this Agreement are intended or will be construed to confer upon or give to any person or entity other than The Regents and the Licensee any rights, remedies or other benefits under, or by reason of, this Agreement, [\*\*\*]. In performing their respective duties under this Agreement, each of the parties hereto will be operating as an independent contractor. Nothing contained herein will in any way constitute any association, partnership, or joint venture between the parties hereto, or be construed to evidence the intention of the parties hereto to establish any such relationship. Neither party will have the power to bind the other party or incur obligations on the other party's behalf without the other party's prior written consent.

IN WITNESS WHEREOF, The Regents and the Licensee have executed this Agreement, in duplicate originals, by their respective and duly authorized officers on the respective dates shown below under their signatures.

------

**<u>Exhibit 10.19</u>**

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| | |
|:---|:---|
| &nbsp;&nbsp;INTELLIKINE, INC.<br>By: <u>/s/ Troy Wilson</u><br>(Signature)<br>Name: Troy Wilson<br>Title: Chief Executive Office and President<br>Date signed: August 10, 2007<br>| &nbsp;&nbsp;THE REGENTS OF THE UNIVERSITY<br>OF CALIFORNIA<br>By: <u>/s/ Joel B. Kirschbaum</u><br>(Signature)<br>Name: Joel B. Kirschbaum<br>Title: Director, UCSF Office of<br> Technology Management<br>Date signed: August 10, 2007<br>|

---

------

**<u>Exhibit 10.19</u>**

**<u>APPENDIX A</u>** 

**<u>ORIGIN</u><u>A</u><u>L MATERIALS</u>**

[\*\*\*]

------

**<u>Exhibit 10.19</u>**

**<u>APPENDIX B</u>**

**<u>CONSENT TO SUBSTITUTION OF PARTY</u>**

[\*\*\*]

------

**<u>Exhibit 10.19</u>**

**<u>APPENDIX C</u>**

**<u>MATERIAL TRANSFER AGREEMENT</u>**

[\*\*\*]

------

**<u>Exhibit 10.19</u>**

**AMENDMENT NO. 1**

**to the**

**Exclusive License Agreement**

**dated August 10, 2007**

**between**

**THE REGENTS OF THE UNIVERSITY OF CALIFORNIA**

**and**

**INTELLIIKINE INC.**

Effective March 13, 2009, THE REGENTS OF THE UNIVERSITY OF<br>CALIFORNIA ("The Regents"), a California corporation having its statewide<br>administrative offices at 1111 Franklin Street, Oakland, California, 94607-5200, and<br>acting through its Office of Technology Management, University of California San<br>Francisco, 185 Berry Street Suite 4603, San Francisco, CA 94107, ("UCSF"), and<br>Intellikine, Inc., a Delaware corporation having a principal place of business at 10931<br>North Torrey Pines Road, Suite 103, La Jolla, CA 92037 ("Licensee"), agree as follows:

(hereinafter collectively referred to as the "Parties")

**<u>A. BACKGROUND</u>**

A.1 The Regents and Licensee entered into an Exclusive License Agreement dated<br>August 10, 2007 (hereinafter the "Original Agreement") covering [\*\*\*].

A.2 The Regents and Licensee wish to amend the Original Agreement for the purpose<br>of licensing the rights covered in [\*\*\*] to Intellikine, under the terms of the<br>Original Agreement.

**<u>B. AMENDMENT</u>** 

The Original Agreement is hereby amended as follows:

B.1 Paragraph A in Background should be deleted and replaced with:

"A. Certain inventions, generally characterized as [\*\*\*]

[\*\*\*]), (collectively, the "Invention") were made in the course of research at UCSF,<br>by [\*\*\*], all employees of UCSF, [\*\*\*], an employee of the Howard Hughes Medical Institute<br>("HHMI") and a member of the faculty of UCSF, and [\*\*\*], all employees of [\*\*\*], (collectively, the "Inventors") and are claimed in the Patent Rights as defined below."

B.2 A new Paragraph N should be added to Background as follows:

------

**<u>Exhibit 10.19</u>**

"N. [\*\*\*] assigned its rights in UC Case No. [\*\*\*] to The Regents, and accordingly, The Regents has the authority to license [\*\*\*] interest as well as The Regents' interest in the UC Case No. [\*\*\*] to Licensee."

B.3 Paragraph 1.23 ("[\*\*\*] Licensed Product") should be deleted and replaced by:

"1.23 <u>"[\*\*\*] Licensed Product"</u> means a Licensed Product covered by a<br>Valid Claim in any of the Patent Rights that claim priority to [\*\*\*]."

B.4 Paragraph 1.24 <u>("[\*\*\*] Licensed Product")</u> should be deleted and replaced by:

"l.24 <u>"[\*\*\*] Licensed Product"</u> means a Licensed Product covered by<br>a Valid Claim in any of the Patent Rights that claim priority to [\*\*\*]."

B.5 The table in Paragraph 1.33 <u>("Patent Rights")</u> should be deleted and replaced with the<br>following table:

[\*\*\*]

B.6 Sub-paragraph 24.l.4(a) <u>("Notices")</u> should be deleted and replaced by:

"(a) In the case of Licensee:

Intellikine, Inc.

l0931 North Torrey Pines Road

Suite 103

La Jolla, CA 92037

Facsimile: (858) 558-5988

Email: [\*\*\*]

B.7 Sub-paragraph 24.1.4 (b) <u>("Notices")</u> should be deleted and replaced by:

"(b) In the case of The Regents, in each case referring to UC Case Nos. [\*\*\*], as relevant:

The Regents of the University of California

Office of Technology Management

Attention: [\*\*\*]

185 Berry Street, Suite 4603

San Francisco, California 94107"

B.8 Paragraph 24.2 ("Payments") should be deleted and replaced by:

"Payments to The Regents due under this Agreement must be directed to the<br>following address, in each case referring to UC Case Nos. [\*\*\*], as relevant:

Office of Technology Transfer

Attn.: [\*\*\*]

University of California

Office of the President

1111 Franklin Street, 7th Floor

------

**<u>Exhibit 10.19</u>**

Oakland, CA 94607-5200"

This Amnendment shall be deemed an integral part of the Original Agreement. Except as<br>expressly set forth herein, all provisions of the Original Agreement shall remain<br>unchanged and in full force and effect. The Parties express herein their mutual intention<br>that this Amendment shall constitute a legally binding Amendment to the Original<br>Agreement.

This Amendment shall be construed and interpreted pursuant to the laws stipulated in the<br>Original Agreement.

IN WITNESS WHEREOF, the Parties hereto have executed these presents in<br>duplicate by their duly authorized officers or representatives as of the dates below:

**INTELLIKINE INC. THE REGENTS OF THE UNIVERSITY<br> OF CALIFORNIA**

<u>By: /s/ D. Troy Wilson</u> <u>By: /s/ Joel B. Kirschbaum__</u>

<u>Name: D. Troy Wilson</u> <u>Name: Joel B. Kirschbaum______</u>

<u>Title: President and CEO</u> <u>Title: Director, OTM___________</u>

<u>Date: April 27, 2009</u> <u>Date: 4/30/09_______________</u>

------

**<u>Exhibit 10.19</u>**

**AMENDMENT NO. 2 <br>to the<br>Exclusive License Agreement<br>dated August 10, 2007<br>and Amended on March 13, 2009<br>between**

<br> **THE REGENTS OF THE UNIVERSITY OF CALIFORNIA<br>and<br>INTELLIKINE INC.**

Effective July 8, 2009, THE REGENTS OF THE UNIVERSITY OF CALIFORNIA ("The Regents"), a California corporation having its statewide administrative offices at 1111 Franklin Street, Oakland, California, 94607-5200, and acting through its Office of Technology Management, University of California San Francisco, 185 Berry Street Suite 4603, San Francisco, CA 94107, ("UCSF"), and Intellikine, Inc., a Delaware corporation having a principal place of business at 10931 North Torrey Pines Road, Suite 103, La Jolla, CA 92037 ("Licensee") (hereinafter collectively referred to as the "Parties"), agree as follows:

&nbsp;&nbsp;&nbsp;&nbsp;BACKGROUND

The Regents and Licensee entered into an Exclusive License Agreement dated August 10, 2007 and Amended on March 13, 2009 (hereinafter collectively referred to as the "Original Agreement") covering [\*\*\*].

The Regents and Licensee wish to amend the Original Agreement for the purpose of licensing the rights covered in [\*\*\*] to Licensee.

&nbsp;&nbsp;&nbsp;&nbsp;AMENDMENT

The Original Agreement is hereby amended as follows:

AMENDMENT ISSUE FEE

Licensee will pay to The Regents an Amendment Issue Fee of [\*\*\*]. The Amendment Issue Fee is non-refundable, non-cancelable and is not an advance, or otherwise creditable, against any amounts required to be paid by the Licensee under the terms of the Original Agreement.

Paragraph A in Background should be deleted and replaced with:

"A. Certain inventions, generally characterized as "PI3 Kinase Antagonists" (UC Case No. [\*\*\*]), "Kinase Antagonists" (UC Case No. [\*\*\*]), [\*\*\*], (collectively, the "Invention") were

------

**<u>Exhibit 10.19</u>**

made in the course of research by employees of UCSF, [\*\*\*] Howard Hughes Medical Institute ("HHMI"), [\*\*\*] and/or Intellikine, and are claimed in the Patent Rights as defined below."

A new Paragraph 1.44 is hereby added as follows:

"1.44 <u>"[\*\*\*] Licensed Method"</u> means a Licensed Method covered by a Valid Claim in any of the Patent Rights that claim priority to [\*\*\*]."

The table in Paragraph 1.33 ("Patent Rights") is hereby deleted and replaced with the following table:

[\*\*\*]

Section 6 ("Annual License Maintenance Fee") is hereby deleted and replaced by:

"The Licensee will also pay to The Regents a license maintenance fee (the "<u>Annual License Maintenance Fee</u>") of [\*\*\*] beginning on, and payable within [\*\*\*], the [\*\*\*], and twenty-five thousand dollars ($25,000.00) payable within [\*\*\*] after [\*\*\*], until such time as the Licensee is Selling or otherwise Exploiting Licensed Products or Licensed Services and is paying Earned Royalties to The Regents. No Annual License Maintenance Fee will be due or payable, other than any such Annual License Maintenance Fee which otherwise then is due and payable as to prior periods and which has not yet been paid by the Licensee to The Regents, from and after the date upon which the first obligation of the Licensee hereunder to pay and Earned Royalties to The Regents has accrued. Amounts paid by the Licensee to The Regents as Annual License Maintenance Fees are non-refundable, non-cancelable, and will not be credited as an advance against, or otherwise creditable against, any other amounts due from the Licensee to The Regents under this Agreement."

Paragraph 8.2 is hereby deleted and replaced by:

"8.2 The Licensee will also pay to The Regents a Minimum Annual Royalty (the "<u>Minimum Annual Royalty</u>") of twenty-five thousand dollars ($25,000.00) in cash for the life of the Patent Rights during the term hereof, beginning with the year in which the first Sale of the first Licensed Product to be Sold occurs. Such Minimum Annual Royalty will be paid to The Regents [\*\*\*] and will be credited against the Earned Royalties due for the calendar year in which such payment of the Minimum Annual Royalty was made. The Licensee's obligation to pay the Minimum Annual Royalty in the first calendar year in which such first Sale occurs will be prorated for the number of months remaining in such calendar year and will be due the next-occurring [\*\*\*] (along with the Minimum Annual Royalty payment for such next year), to allow for crediting of such prorated year's Earned Royalties. Licensee's obligation to pay a Minimum Annual Royalty as defined in this Section 8.2 will cease on [\*\*\*]."

Section 9 ("MILESTONE PAYMENTS") is hereby deleted and replaced by:

"9. MILESTONE PAYMENTS

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1 With respect to each [\*\*\*] Licensed Product, [\*\*\*] Licensed Product, and [\*\*\*] Licensed Method, the Licensee will pay to The Regents the following amounts for each milestone below achieved by the Licensee or any Affiliate, Joint Venture, or Sublicensee, which

------

**<u>Exhibit 10.19</u>**

will be non-refundable and which may not be credited against any other amounts owed to The Regents by the Licensee under this Agreement (each a "<u>Milestone Payment</u>"):

9.1.1 [\*\*\*];

9.1.2 [\*\*\*];

9.1.3 [\*\*\*];

9.1.4 [\*\*\*];

9.1.5 [\*\*\*];

9.1.6 [\*\*\*];

9.1.7 [\*\*\*];

9.1.8 [\*\*\*];

9.1.9 [\*\*\*];

9.1.10 [\*\*\*];

9.1.11 [\*\*\*];

9.1.12 [\*\*\*];

9.1.13 [\*\*\*];

9.1.14 [\*\*\*];

9.1.15 [\*\*\*];

9.1.16 [\*\*\*];

9.1.17 [\*\*\*];

9.1.18 [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2 Each of the Milestone Payments set forth in Section 9.1 will be payable by the Licensee to The Regents with respect to only the first Licensed Product or Licensed Method to achieve such milestone and regardless of whether the applicable milestone event has been achieved by the Licensee or any Affiliate, Joint Venture, or Sublicensee. All Milestone Payments are due to The Regents within [\*\*\*]."

A new Paragraph 10.9 is hereby added as follows:

"10.9 The Licensee, upon execution of this Agreement, will engage in efforts that are [\*\*\*], to develop and/or Sell a product covered by the [\*\*\*] Licensed Method. In the event that Licensee ceases to develop or Sell the [\*\*\*] Licensed Products, Licensee and The Regents will meet and amend into this Agreement a mutually agreeable and commercially reasonable development plan, with specific diligence requirements, for the [\*\*\*] Licensed Method within [\*\*\*]."

Sub-paragraph 24.1.4(b) ("<u>Notices</u>") is hereby deleted and replaced by:

"(b) In the case of The Regents, in each case referring to UC Case Nos. [\*\*\*] as relevant:

The Regents of the University of California<br>Office of Technology Management<br>Attention: [\*\*\*]<br>185 Berry Street, Suite 4603<br>San Francisco, California 94107"

Paragraph 24.2 ("Payments") is hereby deleted and replaced by:

------

**<u>Exhibit 10.19</u>**

"Payments to The Regents due under this Agreement must be directed to the following address, in each case referring to UC Case Nos. [\*\*\*] as relevant:

Office of Technology Transfer<br>Attn.: [\*\*\*]<br>University of California<br>Office of the President<br>1111 Franklin Street, 7th Floor<br>Oakland, CA 94607-5200"

This Amendment shall be deemed an integral part of the Original Agreement. Except as expressly set forth herein, all provisions of the Original Agreement shall remain unchanged and in full force and effect. The Parties express herein their mutual intention that this Amendment shall constitute a legally binding Amendment to the Original Agreement.

This Amendment shall be construed and interpreted pursuant to the laws stipulated in the Original Agreement.

IN WITNESS WHEREOF, the Parties hereto have executed these presents in duplicate by their duly authorized officers or representatives as of the dates below:

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| | |
|:---|:---|
| &nbsp;&nbsp;**INTELLIKINE INC.**<br>| &nbsp;&nbsp;**THE REGENTS OF THE UNIVERSITY OF CALIFORNIA** |
| &nbsp;&nbsp;By: *<u>/s/ Paul Resnick</u>*<br>Name: <u>Paul Resnick</u><br>Title: <u>Vice President, Business Development</u><br>Date: <u>July 14, 2009</u><br>| &nbsp;&nbsp;By: *<u>/s/ Joel B. Kirschbaum</u>*<br>Name: <u>Joel B. Kirschbaum</u><br>Title: <u>Director, OTM</u><br>Date: <u>7/20/09</u><br>|

---

------

**<u>Exhibit 10.19</u>**

**AMENDMENT NO. 3**

**to the**

**Exclusive License Agreement**

**dated August 10, 2007**

**and amended on March 13, 2009 and July 8, 2009**

**between**

**THE REGENTS OF THE UNIVERSITY OF CALIFORNIA**

**and**

**INTELLIKINE, INC.**

Effective November 30, 2010, THE REGENTS OF THE UNIVERSITY OF CALIFORNIA ("The Regents"), a California corporation having its statewide administrative offices at 1111 Franklin Street, Oakland, California, 94607-5200, and acting through its Office of Technology Management, University of California San Francisco, 185 Berry Street, Suite 4603, San Francisco, CA 94107 ("UCSF"), and Intellikine, Inc., a Delaware corporation having a principal place of business at 10931 North Torrey Pines Road, Suite 103, La Jolla, CA92037 ("Licensee") (hereinafter collectively referred to as the "Parties"), agree as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**A. <u>BACKGROUND</u>**

A.1 The Regents and Licensee entered into a Exclusive License Agreement dated August 10, 2007 and amended on March 13, 2009 and July 8, 2009 (hereinafter collectively referred to as the "Original Agreement").

A-2 To clarify the original intent of the Parties, The Regents and Licensee wish to amend the Original Agreement for the purpose of authorizing the disclosure of certain Proprietary Information to potential Direct Sublicensees.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**B. <u>AMENDMENT</u>**

The Original Agreement is hereby amended as follows:

B-1 Section 31.2 is amended to add the following sentences immediately after the first sentence: "The Licensee may disclose Proprietary Information, to potential Direct Sublicensees, provided that such potential Direct Sublicensees are bound by a like duty of

------

**<u>Exhibit 10.19</u>**

confidentiality as that found in this Article 31 and Licensee immediately notifies The Regents of such disclosure and the identity of such potential Direct Sublicensees. Potential Direct Sublicensees may only disclose Proprietary Information to those of its employees, agents, consultants and contractors who 1) require such Proprietary Information to assist the potential Direct Sublicensee in its evaluation of the Proprietary Information for the purpose of determining the potential Direct Sublicensee's interest in becoming a Direct Sublicensee and 2) are bound by a like duty of confidentiality as that found in this Article 31 and 3) may not use the Proprietary Information for any other purpose. Such employees, agents, consultants, and contractors may not disclose Proprietary Information to any third party."

B-2 The amendment described in B-1 above shall apply retroactively and be effective as of January 1, 2010.

This Amendment shall be deemed an integral part of the Original Agreement. Except as expressly set forth herein, all provisions of the Original Agreement shall remain unchanged and in full force and effect. The Parties express herein their mutual intention that this Amendment shall constitute a legally binding Amendment to the Original Agreement. This Amendment shall be construed and interpreted pursuant to the laws stipulated in the Original Agreement.

IN WITNESS WHEREOF, the Parties hereto, have executed these presents in duplicate by their duly authorized officers or representatives as of the date below:

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| | |
|:---|:---|
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;INTELLIKINE, INC. | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;THE REGENTS OF THE UNIVERSITY OF CALIFORNIA |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;By:*<u>/s/ Troy Wilson</u>* | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;By:*<u>/s/ Joel B. Kirschbaum</u>* |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Name: <u>Troy Wilson</u> | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Name: <u>Joel B. Kirschbaum</u> |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Title: <u>President and CEO</u> | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Title: <u>Director - OTM</u> |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Date: <u>November 30, 2010</u> | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Date: <u>12/7/10</u> |

---

------

**<u>Exhibit 10.19</u>**

**AMENDMENT NO. 4**

**to the**

**Exclusive License Agreement**

**dated August 10, 2007** 

**and amended on March 13, 2009, July 8, 2009, and November 30, 2010**

**between**

**THE REGENTS OF THE UNIVERSITY OF CALIFORNIA**

**and·**

**TAKEDA PHARMACEUTICALS**

Effective September 8, 2014, THE REGENTS OF THE UNIVERSITY OF CALIFORNIA ("The Regents"), a California corporation having its statewide administrative offices at 1111 Franklin Street, Oakland, California, 94607-5200, and acting through its Office of Innovation, Technology, and Alliances, University of California San Francisco, 3333 California Street, Suite S-11, San Francisco, CA 94143 ("UCSF"), and MILLENIUM PHARMACEUTICALS INC. (doing business as Takeda Pharmaceuticals International Co. "Takeda"), a Delaware corporation having a principal place of business 40 Landsdowne Street, Cambridge, MA 02139 ("Licensee") (hereinafter collectively referred to as the "Parties"), agree as follows:

**A. <u>BACKGROUND</u>**

**A.1** The Regents and Intellikine, Inc. ("Original Licensee") entered into an Exclusive License

Agreement dated August 10, 2007 and amended on March 13, 2009, July 8, 2009, and November 30, 2010 (hereinafter collectively referred to as the "Original Agreement").

**A.2** Takeda has acquired Original Licensee and has executed the Substitution of Parties Agreement per terms of the Original Agreement, as of January 6, 2012. All actions of Licensee under the Original Agreement are henceforth deemed to be actions of Takeda.

**A.3** The Parties would like to further amend the Original Agreement to a) clarify certain Licensed Product naming designations, b) extend certain diligence milestones, c) update Use of Name provisions, and d) update the Notices section.

------

**<u>Exhibit 10.19</u>**

**B. <u>AMENDMENT</u>**

The Original Agreement is hereby amended as follows:

**B.1 AMENDMENT ISSUE FEE**

Licensee will pay to The Regents an Amendment Issue Fee of [\*\*\*]. The

Amendment Issue Fee is non-refundable, non-cancelable and is not an advance, or otherwise creditable, against any amounts required to be paid by the Licensee under the terms of the Original Agreement.

**B.2** In Paragraph 1.24-definition <u>of "[\*\*\*] Licensed Product"</u> - the title is hereby changed to

<u>"[\*\*\*] Licensed Product"</u> without altering the definition as specified in the Amendment #1 dated March 13, 2009. Further, the term <u>"[\*\*\*] Licensed Product",</u> in each occurrence of the Original Agreement, is to be replaced by <u>"[\*\*\*] Licensed Product".</u> 

**B.3** In Paragraph 1.23 - definition <u>of "[\*\*\*] Licensed Product"</u> - the following sentence is added to the definition:

"For clarity, the clinical candidate known as [\*\*\*] is to be considered solely a

[\*\*\*] Licensed Product under this Agreement."

**B.4** In Paragraph 10.4 in **Due Diligence**; the phrase "[\*\*\*]", both

occurrences (at lines 10 and 12), is hereby replaced by "[\*\*\*]".

**B.5** Paragraph 10.5.2 in **Due Diligence** is hereby deleted and replaced by:

[\*\*\*].

**B.6** Article 17 ("**Use of Names and Trademarks**") is hereby deleted and replaced by:

Nothing contained in this Agreement will be construed as conferring any right to either party to use in advertising, publicity or other promotional activities any name, trade name, trademark or other designation of the other party (including a contraction, abbreviation or simulation of any of the foregoing), Without the Licensee's prior consent on a case-by-case basis, The Regents may list Licensee's name as a licensee of technology from The Regents and identify Intellikine, Inc. as a UCSF startup without further identifying the technology. Unless required by law or unless consented to in writing by Director of Technology Management, Office of Innovation, Technology, and Alliances, the use by the Licensee of the name "The Regents of the University of California" or the name of any campus of the University of California in advertising, publicity or other promotional activities is expressly prohibited. Licensee may also not use the name of HHMI or of any HHMI employee (including [\*\*\*]) in a manner that reasonably could constitute an endorsement of a commercial Product or service; but that use for other purposes, even if commercially motivated, is permitted provided that (1) the use is limited to accurately reporting factual events or occurrences, and (2) any reference to the name of HHMI or any HHMI employees in press releases or similar materials intended for public release is approved by HHMI in advance.

------

**<u>Exhibit 10.19</u>**

**B.7** Paragraph 24.1 of the Original Agreement ("**Notices**") is hereby deleted and replaced with:

Any notice or payment hereunder shall be deemed to have been properly given when sent in writing in English to the respective address below and shall be deemed effective:

31on the date of delivery if delivered in person,

32on the date of mailing if mailed by first-class certified mail, postage paid, or

33on the date of mailing if mailed by any global express carrier service that requires the recipient to sign the documents demonstrating the delivery of such notice or payment, or

34in the case of notices, if sent by email, on the date the recipient acknowledges having received that email by either an email sent to the sender or by a notice delivered by another method in accordance with this Paragraph 24.1 (Notices), provided that, automated replies and "read receipts" shall not be considered acknowledgement of receipt.

In the case of Licensee:

Millennium Pharmaceuticals, Inc.

40 Landsdowne Street,

Cambridge, MA 02139

Attention: [\*\*\*]

Email: [\*\*\*]

In the case of The Regents:

*For notices:*

Office of Innovation, Technology, and Alliances

3333 California Street, Suite S-11

San Francisco, CA 94143-1209

(for express mail and deliveries use zip 94118)

Attention: [\*\*\*]

Referring to: UC Case Nos. [\*\*\*] as relevant

Email: [\*\*\*]

*For remittance of payments:*

Innovation Alliances and Services

Attn: [\*\*\*]

University of California

Office of the President

1111 Franklin Street, 5th Floor

Oakland, CA 94607-5200

Referring to: UC Case Nos. [\*\*\*] as relevant

**B.7** This Amendment shall be deemed an integral part of the Original Agreement. Except as

------

**<u>Exhibit 10.19</u>**

expressly set forth herein, all provisions of the Original Agreement shall remain unchanged and in full force and effect. The Parties express herein their mutual intention that this Amendment shall constitute a legally binding Amendment to the Original Agreement. This Amendment shall be construed and interpreted pursuant to the laws stipulated in the Original Agreement.

This Amendment may be executed in one or more counterparts, each of which together shall constitute one and the same Agreement. For purposes of executing this Amendment, a facsimile (including a PDF image delivered via email) copy of this Amendment, including the signature pages, will be deemed an original. The parties agree that neither party will have any rights to challenge the use or authenticity of a counterpart of this Amendment based solely on that its signature, or the signature of the other party, on such counterpart is not an original signature.

IN WITNESS WHEREOF, the Parties have executed this Agreement by their respective and duly authorized officers on the day and year written.

MILLENIUM PHARMACEUTICALS, INC. THE REGENTS OF THE UNIVERSITY<br> CALIFORNIA

By: <u>/s/ Karoline K. Shair</u> <u>By: /s/ Sunita Rajdev</u> 

Name: <u>Karoline K. Shair</u> Name: <u>Sunita Rajdev</u> 

Title: <u>Deputy Chief IP Counsel</u> Title: <u>Associate Director</u> 

Date: <u>10/2/14</u> Date: <u>10/2/14</u> 

------

**<u>Exhibit 10.19</u>**

**AMENDMENT NO. 5**

**to the**

**Exclusive License Agreement**

**dated August 10, 2007**

**and amended on March 13, 2009, July 8, 2009, November 30, 2010 and September 8, 2014**

**between**

**THE REGENTS OF THE UNIVERSITY OF CALIFORNIA**

**and**

**TAKEDA PHARMACEUTICALS**

Effective August 4, 2021, THE REGENTS OF THE UNIVERSITY OF CALIFORNIA ("The Regents"), a California corporation having its statewide administrative offices at 1111 Franklin Street, Oakland, California, 94607-5200, and acting through its Office of Technology Management, University of California San Francisco, 185 Berry Street, Suite 4603, San Francisco, CA 94107 ("UCSF"), and MILLENNIUM PHARMACEUTICALS, INC. (doing business as Takeda Pharmaceuticals International Co.), a Delaware corporation having a principal place of business at 40 Landsdowne Street, Cambridge, MA 02139 ("Licensee") (UCSF and Licensee collectively referred to as the "Parties"), agree as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**A. <u>BACKGOUND</u>**

A-1 The Regents and Intellikine, Inc. entered into an Exclusive License Agreement dated August 10, 2007, as amended on March 13, 2009, July 8, 2009, November 30, 2010 and September 8, 2014 (hereinafter collectively referred to as the "Original Agreement"), which Original Agreement was subject to the Substitution of Parties Agreement between Takeda and The Regents dated January 6, 2012.

A-2 To further clarify the confidentiality section (Section 31) of the Original Agreement, The Regents and Licensee wish to amend the Original Agreement for the purpose of authorizing the disclosure of certain Proprietary Information and provide a copy of the Original Agreement and this Amendment No. 5 to potential acquirer(s) of certain Licensee assets that relate to the Original Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**B. <u>AMENDMENT</u>**

The Original Agreement is hereby amended as follows:

B-1 Section 31.2 of the Original Agreement is amended to add the following sentences at the very end of the section: "Further, notwithstanding anything to the contrary in this Agreement, Licensee may disclose the other party's Proprietary Information and provide a copy of the Original Agreement and this Amendment No. 5 to existing or prospective

------

**<u>Exhibit 10.19</u>**

acquirers and collaboration partners of Licensee (including in the context of an asset sale and not a whole company acquisition) in connection with transactions or prospective transactions under appropriate written confidentiality provisions. Existing or prospective acquirers and collaboration partners may only disclose Proprietary Information to those of its officers, directors, employees, agents, consultants, advisors and contractors who 1) require such Proprietary Information to assist such existing or prospective acquirers and collaboration partners in its evaluation of the Proprietary Information and 2) are bound by appropriate written confidentiality provisions and 3) may not use the Proprietary Information for any other purpose. Such officers, directors, en1ployees, agents, consultants, advisors and contractors may not disclose Proprietary Information to any third party."

This Amendment No. 5 shall be deemed an integral part of the Original Agreement. Except as expressly set forth herein, all provisions of the Original Agreement shall remain unchanged and in full force and effect. The Parties express herein their mutual intention that this Amendment No. 5 shall constitute a legally binding amendment to the Original Agreement. This Amendment No. 5 shall be construed and interpreted pursuant to the laws stipulated in the Original Agreement.

IN WITNESS WHEREOF, the Parties hereto have executed these presents in duplicate by their duly authorized officers or representatives as of the date below:

---

| | |
|:---|:---|
| &nbsp;&nbsp;MILLENNIUM PHARMACEUTICALS, INC.<br>By:<u>/s/ Beth Shafer</u><br>Name: <u>Beth Shafer</u><br>Title: <u>Head, Neuroscience, DDS and Externalization BD</u><br>Date: <u>Aug 4 2021</u><br>| &nbsp;&nbsp;THE REGENTS OF<br>THE UNIVERSITY OF CALIFORNIA<br>By: <u>/s/ Gonzalo Barrera-Hernandez</u><br>Name: <u>Gonzalo Barrera-Hernandez</u><br>Title: <u>Sr. Associate Director</u><br>Date: <u>08/04/2021</u><br>|

---

------

**<u>Exhibit 10.19</u>**

**AMENDMENT NO. 6<br>to the<br>Exclusive License Agreement<br>dated August 10, 2007 between<br>THE REGENTS OF THE UNIVERSITY OF CALIFORNIA<br>and<br>CALITHERA BIOSCIENCES, INC.**

Effective February 1, 2022, THE REGENTS OF THE UNIVERSITY OF CALIFORNIA ("The Regents"), a California corporation having its statewide administrative offices at 1111 Franklin Street, Oakland, California, 94607-5200, and acting through its Office of Technology Management, University of California San Francisco, 600 16th Street, Suite S272, San Francisco, CA 94143 ("UCSF"), and CALITHERA BIOSCIENCES, INC., a Delaware corporation having a principal place of business at 343 Oyster Point Blvd., Suite 200, South San Francisco, CA 94080 ("Licensee") (UCSF and Licensee collectively referred to as the "Parties"), agree as follows:

BACKGROUND

The Regents and Intellikine, Inc. entered into an Exclusive License Agreement dated August 10, 2007, as amended on March 13, 2009, July 8, 2009, November 30, 2010, September 8, 2014, and August 4, 2021 (hereinafter collectively referred to as the "Original Agreement"), which Original Agreement was subject to the Substitution of Parties Agreement between Millennium Pharmaceuticals, Inc. and The Regents dated January 6, 2012, and to the Consent to Substitution of Party Agreement between Millennium Pharmaceuticals, Inc., The Regents, and Licensee dated October 18, 2021.

[\*\*\*] Following the terms of Paragraph 10.6, Licensee has consulted with The Regents, and the Parties have determined that an extension of the Diligence Milestone described in Paragraph 10.5.3 is appropriate. [\*\*\*] Accordingly, The Regents and Licensee wish to amend the Original Agreement to [\*\*\*] extend this diligence timeline, and update the Notices section.

AMENDMENT

The Original Agreement is hereby amended as follows:

Paragraph A in the Background is hereby deleted and replaced by:

------

**<u>Exhibit 10.19</u>**

A. "Certain inventions, generally characterized as [\*\*\*], (collectively, the "Invention") were made in the course of research by employees of UCSF, Howard Hughes Medical Institute, and/or Bioseek, and are claimed in the Patent Rights as defined below."

Paragraph 1.33 ("Patent Rights") is hereby deleted and replaced by the following table:

---

| | | |
|:---|:---|:---|
| &nbsp;&nbsp;UC Case Number | &nbsp;&nbsp;United States Application Number | &nbsp;&nbsp;Filing or Issue Date |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] |

---

Paragraph 1.44 is hereby deleted.

Paragraph 9.1 ("Milestone Payments") is hereby deleted and replaced by:

9.1 With respect to each [\*\*\*] Licensed Product and [\*\*\*] Licensed Product, the Licensee will pay to The Regents the following amounts for each milestone below achieved by the Licensee or any Affiliate, Joint Venture, or Sublicensee, which will be non-refundable and which may not be credited against any other amounts owed to The Regents by the Licensee under this Agreement (each a "Milestone Payment"):

9.1.l [\*\*\*];

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.2 [\*\*\*];

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.3 [\*\*\*];

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.4 [\*\*\*];

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.5 [\*\*\*]; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.6 [\*\*\*].

Paragraph 10.3 in Due Diligence is hereby deleted and replaced by:

10.3 [\*\*\*]

Paragraph 10.4 in Due Diligence is hereby deleted and replaced by:

Left intentionally blank.

Paragraph 10.5.3 in Due Diligence is hereby deleted and replaced by:

[\*\*\*]

Paragraph 10.9 is hereby deleted.

Paragraph 24.1 of the Original Agreement ("Notices") is hereby deleted and replaced with:

Any notice or payment hereunder shall be deemed to have been property given when sent in writing in English to the respective address below and shall be deemed effective:

on the date of delivery if delivered in person, on the date of mailing if mailed by first-class certified mail, postage paid, or on the date of mailing if mailed by any global express carrier

------

**<u>Exhibit 10.19</u>**

service that requires the recipient to sign the documents demonstrating the delivery of such notice or payment, or in the case of notices, if sent by email, on the date the recipient acknowledges having received that email by either an email sent to the sender or by a notice delivered by another method in accordance with this Paragraph 24.1 (Notices), provided that, automated replies and "read receipts" shall not be considered acknowledgement of receipt.

In the case of Licensee:

Calithera Biosciences, Inc.<br>343 Oyster Point Blvd., Suite 200<br>South San Francisco, CA 94080<br>Attention: [\*\*\*]<br>Email: [\*\*\*]

With a copy to:

Calithera Biosciences, Inc.<br>343 Oyster Point Blvd., Suite 200<br>South San Francisco, CA 94080<br>Attention: [\*\*\*]<br>Email: [\*\*\*]

In the case of The Regents:

*For notices:*

University of California, San Francisco<br>Innovation Ventures, Office of Technology Management, Box 2142<br>600 16th Street, Suite S272<br>San Francisco, CA 94143<br>(for Fed-Ex use postal code 94158)<br>Attention: [\*\*\*]<br>Referring to: [\*\*\*]<br>Email: [\*\*\*]

*For remittance of payments:*

Innovation Alliances and Services<br>Attn: Accounts Receivable<br>University of California Office of the President<br>1111 Franklin Street, 5th Floor<br>Oakland, CA 94607-5200<br>Referring to: [\*\*\*]

This Amendment No. 6 shall be deemed an integral part of the Original Agreement. Except as expressly set forth herein, all provisions of the Original Agreement shall remain unchanged and in full force and effect. The Parties express herein their mutual intention that this Amendment No. 6 shall constitute a legally binding amendment to the Original Agreement. This Amendment No. 6 shall be construed and interpreted pursuant to the laws stipulated in the Original Agreement.

This Amendment may be executed in one or more counterparts, each of which together shall constitute one and the same Agreement. For purposes of executing this Amendment, a PDF copy of this Amendment, including signature pages, will be deemed an original.

------

**<u>Exhibit 10.19</u>**

IN WITNESS WHEREOF, the Parties hereto have executed these presents in duplicate by their duly authorized officers or representatives as of the date below:

---

| | |
|:---|:---|
| &nbsp;&nbsp;**The Regents of the University of California** | &nbsp;&nbsp;**Calithera Biosciences, Inc.** |
| &nbsp;&nbsp;By:<br>Name: <u>Gonzalo Barrera-Hernandez</u><br>Title: <u>Director</u><br>Date: <u>2/4/2022</u> | &nbsp;&nbsp;By:<br>Name: <u>Susan M. Molineaux, Ph.D.</u><br>Title: <u>President & Chief Executive Officer</u><br>Date: <u>2/8/2022</u> |

---

------

## Exhibit 10.20

*Exhibit 10.20*

*CERTAIN INFORMATION HAS BEEN EXCLUDED FROM THIS AGREEMENT (INDICATED BY "[\*\*\*]") BECAUSE SUCH INFORMATION IS BOTH (A) NOT MATERIAL AND (B) THE TYPE THAT THE REGISTRANT CUSTOMARILY AND ACTUALLY TREATS AS PRIVATE OR CONFIDENTIAL.*

LICENSE AGREEMENT

BY AND BETWEEN

TAKEDA PHARMACEUTICAL COMPANY LIMITED

AND

PETRA PHARMA CORPORATION

------

Exhibit 10.20

**LICENSE AGREEMENT**

This License Agreement ("**Agreement**") is dated as of March 18, 2019 (the "**Effective Date**") by and between Takeda Pharmaceutical Company Limited having a business address at 1-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo 103-8636, Japan ("**Takeda**"), and Petra Pharma Corporation, having a business address at 450 E 29th St., Suite 506, New York, NY 10016 ("**Petra**"). Each of Takeda and Petra may be referred to herein separately as a "**Party**" or together as the "**Parties**".

**RECITALS**

**WHEREAS**, Takeda owns or Controls certain intellectual property, including patents, know-how and data, and certain materials relating to Takeda's PI3Kα-selective inhibitor known as TAK-117, and the discovery and development thereof, and Takeda has completed certain clinical trials of TAK-117 in patients; and

**WHEREAS**, Petra desires to exclusively license from Takeda and Takeda desires to exclusively license to Petra the right to use and otherwise exploit such intellectual property to develop, manufacture and commercialize the Licensed Compounds and Products in the Field in the Territory (as such terms are defined below).

**NOW, THEREFORE**, in consideration of the mutual promises and undertakings set forth herein, mid intending to be legally bound hereby, the Parties agree as follows:

**Article 1**<br>**DEFINITIONS**

Unless otherwise defined elsewhere in the Agreement, all capitalized terms shall have the following meanings:

**1.1** "**Adverse Event**" means any serious untoward medical occurrence in a patient or subject who is administered any Product, but only if and to the extent that such serious untoward medical occurrence is required under Laws to be reported to applicable Regulatory Authorities.

**1.2** "**Affiliate**" means, with respect to a particular Party, a person, corporation, partnership, or other entity that controls, is controlled by or is under common control with such Party. For the purposes of this definition, the word "control" (including, with correlative meaning, the terms "controlled by" or "under the common control with") means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of such entity, whether by the ownership of fifty percent (50%) or more of the voting stock of such entity, or by contract or otherwise.

**1.3** "**Bankruptcy Event**" means: (a) voluntary or involuntary proceedings by or against a Party are instituted in bankruptcy under any insolvency Law, which proceedings, if involuntary, shall not have been dismissed within [\*\*\*]; (b) a receiver or custodian is appointed for a Party; (c) proceedings are instituted by or against a Party for corporate reorganization, dissolution, liquidation or winding-up of such Party, which proceedings, if involuntary, shall not have been dismissed within [\*\*\*]; or (d) substantially all of the assets of a Party are seized or attached and not released within [\*\*\*].

------

Exhibit 10.20

**1.4** "**Calendar Quarter**" means each three (3) month period commencing January 1, April 1, July 1 or October 1 of any year; provided, however, that (a) the first Calendar Quarter of the Term shall extend from the Effective Date to the end of the first full Calendar Quarter thereafter, and (b) the last Calendar Quarter of the Term shall end upon the expiration or termination of this Agreement.

**1.5** "**Calendar Year**" means the period beginning on January 1 and ending on December 31 of the same year; provided, however, that (a) the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the same year and (b) the last Calendar Year of the Term shall commence on January 1 of the Calendar Year in which this Agreement terminates or expires and end on the date of termination or expiration of this Agreement.

**1.6** "**Commercialization**" or "**Commercialize**" means any and all commercialization activities undertaken for any Product(s) including, but not limited to, the marketing, commercial strategy, pricing, promoting, distributing, physician targeting, reimbursement, branding, importing or exporting for sale, offering for sale and selling of the Product, and interacting with Regulatory Authorities regarding the foregoing.

**1.7** "**Commercially Reasonable Efforts**" means: [\*\*\*]. For clarity, Commercially Reasonable Efforts will not mean that a Party guarantees that it will actually accomplish the applicable task or objective or achieve any particular result.

**1.8** "**Confidential Information**" of a Party means all information relating to the business, operations or products of a Party or any of its Affiliates, including any Know-How, that such Party discloses to the other Party under this Agreement, or otherwise becomes known to the other Party by virtue of this Agreement, without regard as to whether any of the foregoing is marked "confidential" or "proprietary," or that is disclosed in oral, written, graphic, or electronic form. Confidential Information shall include: (a) the terms and conditions of this Agreement; and (b) Confidential Information disclosed by either Party pursuant to the Confidentiality Agreement between Petra and Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, dated [\*\*\*].

**1.9** "**Control**", "**Controlling**" or "**Controlled**" means, with respect to a given Party or its Affiliate and a given (a) Patent Right, (b) Know-How, (c) intellectual property right not otherwise encompassed by (a) or (b), or (d) biological, chemical or physical material, that such Party or its Affiliate owns or has a license or sublicense to such Patent Rights, Know-How, intellectual property right, or material, (and in the case of material, has the right to physical possession of such material) and has the ability (without taking into account any rights granted by one Party to the other Party under the terms of this Agreement) to grant access, a license, or sublicense to, or assign its right, title and interest in and to, such Patent Rights, Know-How, information, intellectual property, or material, as provided for in this Agreement without violating the terms of any agreement or other arrangement with any Third Party.

**1.10** "**Development**" or "**Develop**" means, with respect to any Licensed Compounds or Product: all activities that relate to (a) obtaining, maintaining or expanding Regulatory Approval of a Product for one or more indications in the Field and in the Territory, including (i) the performance of all research and non-clinical development (including toxicology, pharmacology, test method development, formulation development, delivery system development, stability testing, process development, quality control development, and statistical analysis); (ii) the conduct of any clinical trials; (iii) clinical manufacturing and labelling activities; and (iv) regulatory activities that are required to obtain or maintain Regulatory Approval of a Product in the Territory, as well as (b) developing the process for the manufacture of clinical and commercial quantities of Product.

------

Exhibit 10.20

**1.11** "**Exploit**" or "**Exploitation**" means to research, Develop, make, have made, import, export, use, have used, sell, have sold, offer for sale, or otherwise dispose of or Commercialize.

**1.12** "**FDA**" means the United States Food and Drug Administration or a successor federal agency thereto.

**1.13** "**Field**" means all human therapeutic uses except for the excluded Indications set forth in <u>Exhibit A</u> (the "**Excluded indications**") attached hereto.

**1.14** "**First Commercial Sale**" means, on a country-by-country basis, the first commercial transfer or disposition for value of any Product in such country to a Third Party by Petra or any of its Sublicensees. Transfers or dispositions of Product: (a) in connection with patient assistance programs; (b) for charitable or promotional purposes; (c) for preclinical, clinical, regulatory or governmental purposes or under so-called "named patient" or other limited access programs; or (d) for use in any tests or studies reasonably necessary to comply with any Law, regulation or request by a Regulatory Authority shall not, in each case of (a) through (d), be deemed commercial transfers or dispositions for value.

**1.15** "**Generic Competition Percentage**" means, with respect to each Product in a given country in the Territory in a given [\*\*\*], the total number of units of all Generic Products sold by one or more Third Parties divided by the sum of (a) the total number of units of the applicable Product sold by Petra, its Affiliates and Sublicensees and (b) the total number of units of all Generic Products sold by one or more Third Parties in such country.

**1.16** "**Generic Product**" means, with respect to a particular Product in a particular country, any pharmaceutical product (other than the Product sold under authority from Petra) that contains the same active ingredient(s) and route of administration as such Product and has received Marketing Approval in such country.

**1.17** "**Governmental Body**" means any: (a) nation, principality, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature; (b) federal, state, local, municipal, foreign or other government; (c) governmental or quasi-governmental authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, board, instrumentality, officer, official, representative, organization, unit, body or entity and any court or other tribunal); (d) multi-national or supranational organization or body; or (e) individual, entity, or body exercising, or entitled to exercise, any executive, legislative, judicial, administrative, regulatory, police, military or taxing authority or power of any nature.

**1.18** "**IND**" means, in the United States, a Claimed Investigational New Drug Application filed with the FDA as more fully defined in 21 C.F.R. §312.3, and, with respect to every other country in the Territory, the clinical trial notification, clinical trial application or other equivalent application (i.e., a filing that must be made prior to commencing clinical testing of any Product in humans) filed with the applicable Regulatory Authority in such country.

**1.19** "**Indication**" means a generally acknowledged disease or condition, a significant manifestation of a disease or condition, or symptoms associated with a disease or condition or a risk for a disease or condition for which an NDA may be obtained.

**1.20** "**Know-How**" means any: (a) scientific or technical information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, that is not in the public domain or

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Exhibit 10.20

otherwise publicly known, including discoveries, inventions, trade secrets, devices, databases, practices, protocols, regulatory filings, methods. processes (including manufacturing processes, specification and techniques), techniques, concepts, ideas, specifications, formulations, formulae, data (including pharmacological, biological, chemical, toxicological, clinical and analytical information, quality control, trial and stability data), case reports forms, medical records, data analyses, reports, studies and procedures, designs for experiments and tests and results of experimentation and testing (including results of research or development), summaries and information contained in submissions to and information from ethical committees or Regulatory Authorities, and manufacturing process and development information, results and data, whether or not patentable, all to the extent not claimed or disclosed in a patent or patent application; and (b) compositions of matter, assays, animal models and physical, biological or chemical material, including drug substance samples, intermediates of drug substance samples, drug product samples and intermediates of drug product samples. The fact that an item is known to the public shall not be taken to exclude the possibility that a compilation including the item, and/or a development relating to the item, is (and remains) not known to the public. "Know-How" includes any rights including copyright, database or design rights protecting such Know-How. "Know-How" excludes Patent Rights.

**1.21** "**Law**" or "**Laws**" means all applicable laws, statutes, rules, regulations, ordinances and other pronouncements having the binding effect of law of any Governmental Body.

**1.22** "**Licensed Compound**" means: (i) Takeda's PI3Kα-selective inhibitor known as TAK-117 (MLN1117); (ii) the chemical compounds coded by Takeda as [\*\*\*] and [\*\*\*]; and (iii) any analogs, derivatives, fragments or modifications of the aforementioned compounds described in clause (i) or (ii) that are obtained by Petra using the aforementioned compounds.

**1.23** "**MAA**" means a Marketing Authorization Application filed with the European Medicines Agency ("**EMA**").

**1.24** "**Marketing Approval**" shall mean approval from the relevant Regulatory Authority in a given country necessary to market and sell a pharmaceutical product in such country, which for the sake of clarity, shall not include pricing and reimbursement approval.

**1.25** "**NDA**" means a New Drug Application, submitted pursuant to the requirements of the FDA, as more fully defined in 21 US C.F.R. § 3143 et seq., and any equivalent application (e.g., MAA) submitted in any country in the Territory, including all additions, deletions or supplements thereto, and as any and all such requirements may be amended, or supplanted, at any time.

**1.26** "**Net Sales**" means the gross amounts received by Petra or any of its Sublicensees for sales of Products to independent or unaffiliated Third Party purchasers of such Product, less the following deductions with respect to such sales that are either included in the billing as a line item as part of the gross amount invoiced, or otherwise documented as a deduction in accordance with United States generally accepted accounting principles ("**US GAAP**") or International Financial Reporting Standards ("IFRS"), as applicable, to be specifically attributable to actual sales of such Product: [\*\*\*]. For clarity, a particular deduction may only be accounted for once in the calculation of Net Sales.

[\*\*\*]

In the event a Product is sold as a combination or bundled product that consists of a Licensed Compound or Product together with another therapeutically active product (a "**Combination** 

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Exhibit 10.20

**Product**"), the Net Sales from the Combination Products, for the purposes of determining Royalty Payments, will be determined by [\*\*\*].

[\*\*\*]

[\*\*\*]

**1.27** "**Patent Rights**" means any: (a) issued or granted patent, including any extension, supplemental protection certificate, registration, confirmation, reissue, reexamination or renewal thereof; (b) pending patent applications, including, but not limited to, any continuation, divisional, continuation-in-part, substitute or provisional application; and (c) counterparts or foreign equivalents of any of the foregoing filed or issued in any country or jurisdiction.

**1.28** "**Person**" means any individual, sole proprietorship, partnership, corporation, limited liability company, joint stock company, unincorporated association, trust, or any other entity that has legal capacity to own property in their own name or to sue or be sued, including a government or political subdivision, department, or agency of a government.

**1.29** "**Phase I Trials**" means Takeda's clinical trials entitled [\*\*\*].

**1.30** "**Product**" means any product comprising a Licensed Compound, either as the sole active ingredient or in combination with one or more other active ingredients, including all forms, presentations, strengths, doses and formulations (including any method of delivery). For clarity, for the purposes of this Agreement: different dosage strengths of a given Product comprising a given Licensed Compound, regardless of formulation, shall be considered the same Product, but any Product which has a different Licensed Compound from another Product shall be considered a different Product.

**1.31** "**Regulatory Approval**" means any and all approvals, licenses, registrations, or authorizations of the relevant Regulatory Authority, including any pricing and/or pricing reimbursement approval or determination, necessary for the Development, manufacture, use, storage, import, transport or Commercialization of Product in a particular country or jurisdiction.

**1.32** "**Regulatory Authority**" means (a) in the US, the FDA or (b) in any other jurisdiction anywhere in the world, any regulatory body with similar regulatory authority over pharmaceutical products (including without limitation, the EMA).

**1.33** "**Regulatory Exclusivity**" means, with respect to a Product, any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to such Product, other than Patent Rights, that prohibits a Person from (a) relying on pivotal safety or efficacy data generated by or on behalf of the Parties with respect to such Product in an application for Regulatory Approval, (b) Commercializing such Product, including rights conferred in the US under the Hatch Waxman Act or the FDA Modernization Act of 1997 (including pediatric exclusivity and orphan drug exclusivity), or in each case ((a) and (b)), rights similar thereto outside the US.

**1.34** "**Royalty Term**" means, on a Product-by-Product and country-by-country basis, the period from the First Commercial Sale of such Product in such country until the latest of (a) the expiration of the last to expire Valid Claim of a Takeda Patent in such country, (b) the expiration of any applicable Regulatory Exclusivity period for the Product in such country or (c) ten (10) years after the First Commercial Sale of such Product in such country.

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Exhibit 10.20

**1.35** "**Sublicensee**" means a Person which is granted any sublicense rights under any of the license rights granted under <u>Section 2.1</u>; *provided, however*, that "Sublicensee" shall exclude distributors who are independent contractors of Petra.

**1.36** "**Takeda Know-How**" means that Know-How listed in <u>Exhibit B</u>. For clarity, Know-How that relates to a Licensed Compound or Product in combination with any other compound is explicitly excluded.

**1.37** "**Takeda Patents**" means patents and patent applications listed in <u>Exhibit C</u> together with (a) issued or granted patents, including any extension, supplemental protection certificate, registration, confirmation, reissue, reexamination or renewal thereof, and the like of any of the foregoing; (b) pending patent applications, including, but not limited to, any continuation, divisional, continuation-in-part, substitute or provisional application thereof, and the like of any of the foregoing; and (c) counterparts or foreign equivalents thereof filed or issued in any country or jurisdiction.

**1.38** "**Takeda Technology**" means, collectively, the Takeda Patents and the Takeda Know-How.

**1.39** "**Tax**" or "**Taxes**" means any federal, state, local or foreign income, gross receipts, license, payroll, employment, excise, severance, stamp, occupation, premium, windfall profits, environmental, customs duties, capital stock, franchise, profits, withholding, social security, unemployment, disability, real property, personal property, sales, use, transfer, registration, value added, alternative or add-on minimum, estimated, or other tax of any kind whatsoever, including any interest, penalty, or addition thereto, whether disputed or not.

**1.40** "**Territory**" means all the countries of the world.

**1.41** "**Third Party**" means any Person other than Takeda, Petra or any of their respective Affiliates.

**1.42** "**Third Party Action**" means any Action (as defined in Section 6.4(b) below) made by a Third Party against either Party that claims that any Licensed Compounds or any Product, or its use, importation, Development, or Commercialization infringes or misappropriates such Third Party's intellectual property rights.

**1.43** "**United States**" or "**US**" means the United States of America, its territories and possessions.

**1.44** "**USD**" or "**$**" means the lawful currency of the United States.

**1.45** "**Valid Claim**" means with respect to a patent or patent application in a country, any claim of an (a) issued patent that has not (i) expired, irretrievably lapsed or been abandoned, revoked, dedicated to the public or disclaimed or (ii) been found to be unpatentable, invalid or unenforceable by an unreversed and unappealable final decision of a governmental authority in such country or (b) application for a patent that (1) has been pending for less than [\*\*\*], is being prosecuted in good faith, and has not been abandoned or finally disallowed without the possibility of appeal or re-filing and (2) has not been admitted to be invalid or unenforceable through reissue, reexamination, or disclaimer.

**1.46** "**VAT**" means, within the EU, such Tax as may be levied in accordance with (but subject to derogations from) Directive 2006/112/EC and, outside the EU, value added tax or any form of consumption tax levied by a relevant Tax authority, as well as all other forms of consumption taxes levied by the relevant Tax authority on the purchase of a good or a service, including but not limited to sales tax and good and service tax.

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Exhibit 10.20

**Article 2**<br>**LICENSES AND OTHER RIGHTS**

**2.1 Grant of Licenses to Petra**. Subject to the terms and conditions of this Agreement, Takeda on behalf of itself and its Affiliates hereby grants to Petra an exclusive (even as to Takeda and its Affiliates, except as expressly provided in <u>Section 2.2</u> or in <u>Section 10</u>), royalty-bearing and transferable (subject to the provisions of <u>Section 12.2</u>) right and license (with the right to sublicense through multiple tiers, subject to the provisions of <u>Section 2.4</u>) under the Takeda Technology to Exploit the Licensed Compounds and Products in the Territory in the Field.

**2.2 License to Takeda**. Petra hereby grants to Takeda and its Affiliates a non-exclusive, royalty-free, irrevocable, fully paid up, sublicensable through multiple tiers, license to use and practice the Takeda Technology in the Field for internal non-clinical research and non-clinical development purposes only.

**2.3 Covenant Not to Sue; Other Takeda Patents**. In exchange for the consideration described herein, Takeda covenants that it will not, and it will cause its Affiliates not to, initiate, institute, prosecute or pursue any claim, complaint, suit action or other judicial or administrative proceeding anywhere in the world against Petra, its Affiliates or Sublicensees (or their successors in interest), asserting that the use, manufacture (but not methods of manufacture), sale or offer for sale, or import of TAK-117 [\*\*\*], [\*\*\*], or [\*\*\*] (as described in the definition of Licensed Compound) by Petra, its Affiliates or its Sublicensees (or their successors in interest), as the case may be, constitutes infringement (including direct, contributory or inducement of infringement) of a [\*\*\*] claim of a Patent Right (other than a Takeda Patent) owned or Controlled by Takeda or its Affiliates. For clarity, this <u>Section 2.3</u> does not apply to the extent that the Exploitation of the aforementioned compounds by Petra, its Affiliates or its Sublicensees (or their successors in interest), as the case may be, constitutes infringement of any other Patent Right Controlled by Takeda (e.g., [\*\*\*]). To the extent that Petra, in the conduct of the Development or other Exploitation of one or more Products, identifies one or more Patent Rights it believes are owned or Controlled by Takeda or its Affiliates which are not Takeda Patents and which are not included within the foregoing covenant not to sue, but which cover or claim a method of manufacture, or formulation of, or use of, such Product (the "**Other Takeda Patents**"), and requests to discuss with Takeda or its Affiliate obtaining a license under any such Other Takeda Patent(s) for such Product, Takeda agrees to meet and discuss with Petra, in good faith, the grant of such a license on commercially reasonable terms unless Takeda does not in fact have the right to grant any such license under such Other Takeda Patent as of such time, in which case it will inform Petra of such fact.

**2.4 Grant of Sublicenses by Petra**. Prior to such time as Petra has completed the first clinical trial of a Licensed Compound, Petra may not grant sublicenses (with or without the right to grant further sublicenses through multiple tiers), in whole or in part, under the licenses granted in <u>Section 2.1</u> without the prior written consent of Takeda, such approval not to be unreasonably withheld. If Takeda approves any sublicense, such approval shall not relieve Petra of any of its obligations hereunder. If Takeda's prior written consent is required for Petra to sublicense its rights to Exploit any Compounds or Products, in whole or in part, to a Third Party, Takeda may not unreasonably withhold, condition or delay any such consent, and if Takeda fails to reject in writing any such proposed sublicense within [\*\*\*], then Takeda shall be deemed to have consented to such sublicense. Following such time as Petra has completed the first clinical trial of a Licensed Compound, Petra shall have the right to grant sublicenses under any of the licenses granted in <u>Section 2.1</u> (which sublicensed rights shall be further sublicenseable through multiple tiers) to any of its Affiliates or to any Third Party, with prior written notice to Takeda, but without Takeda's consent, and subject to the requirements of this <u>Section 2.4</u>. Any sublicense granted by Petra in

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Exhibit 10.20

accordance with the terms of this <u>Section 2.4</u> shall be in writing and subject to, and consistent with, the terms and conditions of this Agreement to the extent applicable. In addition, any such sublicense shall include an obligation on the Sublicensee to [\*\*\*]. Petra shall provide Takeda with a copy of any sublicense agreement, and any amendment thereto, within [\*\*\*]; *provided* that Petra shall have the right to redact from such copy of the sublicense agreement any (a) Financial terms and (b) other technical or business information which Petra determines in good faith to be necessary to protect any of its or its Sublicensee's confidential or proprietary information unrelated to Petra's obligations under this Agreement.

**2.5 Material Transfer**. Takeda shall transfer to Petra or its designee, upon Takeda's receipt of Petra's reasonable written instructions with respect to shipping method, delivery address and carrier, and at Petra's cost and expense, such amount of the Licensed Compounds as more explicitly set forth on <u>Exhibit D</u>. The Licensed Compounds shall be transferred as-is. Takeda shall use Commercially Reasonable Efforts to conduct such transfer to Petra within [\*\*\*].

**2.6 Patent Transfer**. Except as noted in <u>Section 2.7</u>, Takeda shall use Commercially Reasonable Efforts to transfer to Petra or its designee, within [\*\*\*], and [\*\*\*], a copy of all files related to the Takeda Patents listed on <u>Exhibit C</u>, each in their current form and language.

**2.7 Data Transfer**. Takeda shall transfer to Petra, following receipt by Takeda of written instructions from Petra with respect to the transfer, and [\*\*\*], all Takeda Know-How that may be transferred in accordance with applicable Law. If during [\*\*\*], Petra makes a written request to Takeda for additional Know-How relating solely to a Licensed Compound or Product that is owned or Controlled by Takeda and is not included on <u>Exhibit B</u>, Takeda shall consider such request in good faith and use reasonable efforts to promptly transfer to Petra any such Know-How that is in its Control and [\*\*\*] and in accordance with applicable Law, [\*\*\*]. Takeda shall further provide Petra with reasonable access, upon advance written notice and during normal business hours, to a representative of Takeda who is familiar with, and has the relevant expertise related to, the Licensed Compounds for questions and assistance relating to such data. Takeda shall use Commercially Reasonable Efforts to conduct such transfer to Petra within [\*\*\*].

**2.8 Regulatory Documents Transfer**. Upon Petra's written request after the Effective Date, Takeda shall (to the extent allowed by Law), [\*\*\*], assign to Petra all applications and filings made by or on behalf of Takeda or its Affiliates with any Regulatory Authority in the Territory that relate solely to any Licensed Compounds or Product, if any, including any IND, NDA or orphan drug designations or any other application for regulatory consultations or consideration, including sponsorship thereof (the "**Regulatory Documents**"). To the extent any of the Regulatory Documents cannot be assigned to Petra, Takeda hereby grants on behalf of itself and its Affiliates to Petra an exclusive (even as to Takeda and its Affiliates) and transferable (subject to the provisions of <u>Section 12.2</u>) license and right of reference under the Regulatory Documents (with the right to sublicense and grant further rights of reference, subject to the provisions of <u>Section 2.4</u>) as necessary to Exploit any Licensed Compounds or Product(s) in the Territory in the Field. For clarity Regulatory Documents relating to a Licensed Compound in combination with any other compound are explicitly excluded, provided, however, that in the event Petra (or its Affiliate or sublicensee) is required by a Regulatory Authority to report any safety data relating solely to a Licensed Compound that was the subject of such a combination study. Takeda will cooperate with Petra to make such information available to such Regulatory Authority.

**2.9 Authorization to Communicate with Vendors**. Takeda shall, promptly after the Effective Date, provide Petra with letters from Takeda to submit to the following vendors that have been involved in the development of the Licensed Compound TAK-117, which list includes vendors involved in

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Exhibit 10.20

Development or manufacture of TAK-117 intermediates, regulatory starting materials, drug substance, drug product, and nonclinical studies, the purpose of which letters shall be to instruct such vendors to provide to Petra access to all data and material related solely to such Development or manufacture of TAK-117: [\*\*\*].

**2.10 Confirmatory License**. Takeda shall, if requested to do so by Petra, promptly enter into a confirmatory license in a form reasonably requested by Petra for purposes of recording the licenses granted under this Agreement with such patent offices or other Regulatory Authorities as Petra considers appropriate.

**2.11 No Excluded Indications Licenses**. Notwithstanding anything herein to the contrary, during the Term of this Agreement, Petra shall not, by itself or through a Third Party, directly or indirectly, use the Takeda Technology to research, Develop, manufacture, have manufactured, use, Commercialize, market, have marketed, sold, have sold or otherwise Exploit the same with respect to the Excluded Indications. During the Term, to the extent the rights to Exploit any Licensed Compound in the Excluded Indications revert to Takeda or its Affiliates, Takeda and its Affiliates shall not, by themselves or through a Third Party, directly or indirectly, use the Takeda Technology to Develop, manufacture, have manufactured, Commercialize, market, have marketed, sold, have sold or otherwise Exploit such Licensed Compound in the Field, except that Takeda shall have the right to use and practice such Licensed Compound in the Field for internal non-clinical research and development purposes in accordance with <u>Section 2.2</u> above.

Except as expressly set forth herein, no license or other right is or shall be created or granted under this Agreement by implication, estoppel or otherwise. All licenses and rights after the Effective Date and during the remainder of the Term are or shall be granted only as expressly provided in this Agreement. All rights not expressly granted by a Party under this Agreement are reserved by such Party and may not be used by the other Party for any purpose.

**Article 3**<br>**DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION OF PRODUCT**

**3.1 Development of Products by Petra**. Petra shall have the sole responsibility and decision-making authority to Develop the Licensed Compounds and Products and to conduct (either itself or through its agents, subcontractors and/or Sublicensees) all clinical trials and non-clinical studies Petra believes appropriate to obtain Regulatory Approval for such Products in the Territory in the Field. As between the Parties, Petra shall be solely responsible for all costs and expenses associated with such Development. Petra will provide [\*\*\*] written update to Takeda, specifying the current Development status and progress of the Licensed Compound(s) and/or Product(s) and summarizing Petra's (and its Affiliates' and Sublicensees') significant activities relating to Development, Commercialization (to the extent applicable), and other Exploitation of each Product, within [\*\*\*] during the Term. Such [\*\*\*] report shall be complete and accurate in all material respects.

**3.2 Commercialization**. Petra shall have the sole responsibility and decision-making authority to Commercialize Products itself or through one or more Sublicensees or other Third Parties selected by Petra in accordance with this Agreement and shall have the sole decision-making authority and responsibility in all matters relating to the Commercialization of Products in the Territory in the Field. As between the Parties. Petra shall be solely responsible for all costs and expenses associated with Commercialization.

**3.3 Clinical and Commercial Manufacturing**. Petra shall have sole responsibility for all manufacturing and labeling of the Licensed Compounds and/or Product(s), including clinical and

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Exhibit 10.20

commercial manufacturing and labeling. Petra has the right to manufacture the Licensed Compounds and Products itself or through one or more Sublicensees or subcontractors selected by Petra in accordance with this Agreement. As between the Parties, Petra shall be solely responsible for all costs and expenses associated with such activities.

**3.4 Diligence by Petra**. Petra shall use Commercially Reasonable Efforts to Develop and Commercialize at least one (1) Product in the Territory. Petra shall have the exclusive right to determine, in its sole discretion, the launch strategy for each Product, subject to its exercise of Commercially Reasonable Efforts] and the availability of any necessary Third Party licenses or other rights. Activities conducted by Petra's Sublicensees will be considered as Petra's activities under this Agreement for purposes of determining whether Petra has complied with its obligation to [use Commercially Reasonable Efforts. Petra shall be relieved of its diligence obligations under this <u>Section 3.4</u> if either Party provides the other Party with a termination notice pursuant to <u>Section 10.2</u>, effective immediately upon delivery of such termination notice.

**3.5 Subcontracting**. Petra may exercise any of its rights, or perform any of its obligations, under this Agreement by subcontracting (including, for example, to fee-for-service or commercial research organizations) the exercise or performance of all or any portion of such rights and obligations on Petra's behalf. For the avoidance of doubt, this provision shall not be construed as permitting the granting of a Sublicense to any sub-contractor other than in accordance with the requirements of <u>Section 2.4</u> and any sub-contractors shall not be considered Sublicensees. Any subcontract granted or entered into by Petra as contemplated by this Section shall be in writing, shall specify the activity or activities subcontracted, and shall impart on the subcontractor the same level of obligation provided hereunder and the same level of protection for Takeda as provided hereunder (in each case as applicable to the subcontracted activities). Subcontracting shall not relieve Petra from any of its obligations under this Agreement. Petra shall be responsible for the performance of and any breaches of this Agreement by its subcontractors. Petra shall ensure that any subcontractors are aware of, and comply with the provisions of this Agreement applicable to the work being performed by such subcontractor.

**3.6 Trademarks**. As between Takeda and Petra, Petra shall have the sole authority to select trademarks for the Products and shall own all such trademarks in the Territory. Throughout the Term of this Agreement and thereafter, Petra shall not adopt or use, register or attempt to register in the Territory any trademark, trade name, domain name, or similar commercial symbol that includes, or is confusingly similar to, Takeda's or any of its Affiliates trademarks or service marks.

**3.7** [**\*\*\***]

**3.8 Abandonment**. If Petra and its Affiliates and Sublicensees abandon Development and Commercialization of all Licensed Compounds and all Products containing any Licensed Compounds, Petra shall promptly notify Takeda of such decision. Upon receipt of such notice of abandonment, Takeda shall have the right, but not the obligation, to terminate this Agreement and take back Development or Commercialization responsibility for the Licensed Compounds, provided Takeda must notify Petra of its decision within [\*\*\*]. If Takeda does not elect to take back such Development or Commercialization responsibility within such [\*\*\*] period, Petra shall be solely responsible [\*\*\*] for the wind down of any such of its Development or Commercialization activities, including any clinical trials [\*\*\*]. If Takeda elects to take back Development or Commercialization of the Licensed Compounds during such [\*\*\*] period, the Parties shall work in good faith to determine which Party shall continue any ongoing research activities, including clinical trials in process and <u>Section 10.31b)(v)</u> shall apply. [\*\*\*].

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Exhibit 10.20

**Article 4**<br>**REGULATORY MATTERS**

**4.1 Regulatory Filings.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a) Petra Responsibilities**. Petra will be solely responsible for all regulatory activities relating to the Licensed Compounds and/or the Products) in the Field, including (i) developing regulatory plans and strategies for the Licensed Compounds and the Product(s), (ii) making all regulatory filings with respect to the Licensed Compounds and the Product(s), and (iii) obtaining and maintaining regulatory approvals for the Product(s). As between Petra and Takeda, Petra shall own and maintain all regulatory filings and Regulatory Approvals for the Products, including all INDs and NDAs, in the Territory. Petra will be solely responsible for all costs associated with such activities. Petra has the right to select the countries where the Licensed Compounds and/or Product(s) will be maintained or submitted for regulatory approval.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b) Regulatory Filings by both Petra and Takeda Licensee**. When Petra files an IND for any Licensed Compound or Product, Petra shall notify Takeda thereof within [\*\*\*]. When the Third Party to whom Takeda has granted rights with respect to the Excluded Indications (the "**Takeda Licensee**") files an IND for any Licensed Compound or Product, Takeda shall notify Petra thereof within [\*\*\*]. If both Petra and the Takeda Licensee file an IND for the same Licensed Compound or Product, Takeda shall facilitate a negotiation between the Takeda Licensee and Petra, subject to which Petra and the Takeda Licensee shall negotiate in good faith and enter into a pharmacovigilance and safety data exchange agreement, which agreement shall be applicable to [\*\*\*] and set forth [\*\*\*]. Takeda's obligations with respect to such negotiations shall be [\*\*\*]. Further, when and if the Takeda Licensee submits a marketing approval application for any such Licensed Compound or Product, Takeda shall notify Petra thereof within [\*\*\*]. In the event that the first marketing approval application of such Product is filed by either Petra or the Takeda Licensee, Petra and the Takeda Licensee shall initiate negotiations with a view to entering into a post-marketing safety data exchange agreement no later than [\*\*\*], which agreement shall be applicable to [\*\*\*] to permit each of Petra and the Takeda Licensee to comply with regulatory and legal requirements regarding the management of safety data by providing for the exchange of relevant information in an appropriate format within applicable timeframes.

**4.2 Communications with Authorities**. Petra (or one of its Sublicensees) shall be responsible, and act as the sole point of contact, for communications with Regulatory Authorities in connection with the Development, Commercialization and manufacturing of Licensed Compounds and Products in the Territory. Following the Effective Date, Takeda shall not initiate (or permit any of its Affiliates to initiate), with respect to any Licensed Compounds or Product, any meetings or contact with Regulatory Authorities in the Territory, without Petra's prior written consent, except as necessary to accomplish the technology transfer pursuant to <u>Section 2.8</u>, in which case Takeda shall keep Petra informed of the status of such transfer. To the extent Takeda or any Affiliate receives any written or oral communication from any Regulatory Authority in the Territory relating to any Licensed Compounds or Product, to the extent not prohibited by Law, Takeda shall (a) refer such Regulatory Authority to Petra, and (b) as soon as reasonably practicable (but in any event within [\*\*\*]), notify Petra and provide Petra with a copy of any written communication received by Takeda or such Affiliate or, if applicable, accurate minutes of such oral communication.

**4.3 Adverse Event Reporting**. Takeda and Petra agree to comply with any and all Laws applicable during the Term in connection with Product safely data collection and reporting, including reporting of Adverse Events. If Takeda or any Affiliate has or receives any information regarding any Adverse Event which may be related to the use of any Product, then Takeda shall provide Petra with

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Exhibit 10.20

all such information in English within such reasonable timelines which enable Petra to comply with all Laws and relevant regulations and requirements.

**4.4 Recalls**. Petra shall have the sole right to determine whether and how to implement a recall or other market withdrawal of Product(s) in the Territory.

**Article 5**<br>**FINANCIAL PROVISIONS**

As consideration for Takeda's grant of rights and licenses to Petra under this Agreement, and fulfilment by Takeda of its other obligations under this Agreement, Petra shall [\*\*\*] and pay the milestone and royalty payments, all as described below in this Article 5.

**5.1** [\*\*\*]

**5.2** [\*\*\*]

**5.3 Milestone Payments**. As consideration for the exclusive license to the Takeda Technology granted under this Agreement, Petra shall pay to Takeda the following one-time milestone payments upon the first and only achievement of each such Milestone Event by the first Product to achieve such Milestone Event:

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| | |
|:---|:---|
| &nbsp;&nbsp;**Milestone Event** | &nbsp;&nbsp;**Payment** |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;$[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;$[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;$[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;$[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;$[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;$[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;$[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;$[\*\*\*] |
| &nbsp;&nbsp;**Total Potential Event Milestone Payments under this Section 5.3:** | &nbsp;&nbsp;**$**[**\*\*\***] |

---

**5.4 Sales Milestone Payments**. As consideration for the exclusive license to the Takeda Technology granted under this Agreement, Petra shall pay to Takeda the following one-time net sales milestone payments within [\*\*\*] after the first and only achievement of each indicated threshold for total Net Sales of the Product achieved during a Calendar Year:

---

| | |
|:---|:---|
| &nbsp;&nbsp;**When Calendar Year Net Sales of the Product First Exceed:** | &nbsp;&nbsp;**Payment** |

---

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Exhibit 10.20

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| | |
|:---|:---|
| &nbsp;&nbsp;$[\*\*\*] | &nbsp;&nbsp;$[\*\*\*] |
| &nbsp;&nbsp;$[\*\*\*] | &nbsp;&nbsp;$[\*\*\*] |
| &nbsp;&nbsp;**Total Potential Sales Milestone <br>Payments under this Section 5.4:** | &nbsp;&nbsp;**$**[**\*\*\***] |

---

**5.5 Notification of Milestone Achievement**. Petra will provide Takeda with prompt written notice of the occurrence of any Milestone Event, in any event no later than [\*\*\*]. Promptly following receipt of the notice of a Milestone Event achievement, Takeda will prepare and deliver to Petra an invoice for the applicable Milestone Payment, which shall be payable within [\*\*\*].

**5.6 Royalty Payments**. Subject to <u>Section 5.7</u>, as consideration for the exclusive license to the Takeda Technology granted under this Agreement, Petra shall, during each applicable Royalty Term; pay to Takeda [\*\*\*] royalty payments, on a Product-by-Product, country-by-country and Calendar Year-by-Calendar Year basis as follows ("**Royalty Payments**"):

---

| | |
|:---|:---|
| &nbsp;&nbsp;**Portion of Calendar Year Net Sales of a Product in the Territory:** | &nbsp;&nbsp;**Royalty Rate** |
| &nbsp;&nbsp;$[\*\*\*] to $[\*\*\*] | &nbsp;&nbsp;[\*\*\*]% |
| &nbsp;&nbsp;> $[\*\*\*] to $[\*\*\*] | &nbsp;&nbsp;[\*\*\*]% |
| &nbsp;&nbsp;> $[\*\*\*] | &nbsp;&nbsp;[\*\*\*]% |

---

Upon the expiration of the Royalty Term with respect to each Product in each country, Petra shall have a fully paid-up, irrevocable license with respect to such Product in such country.

**5.7 Reductions.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a) Anti-Stacking**. If, based on the opinion of counsel that such is necessary for avoiding infringement or misappropriation of Third Party intellectual property rights, Petra, its Affiliate or any of its Sublicensees enters into any Third Party license agreements in order to Exploit the Takeda Technology, including in connection with settlement of any Third Party Action, Petra will be entitled to deduct [\*\*\*] of the amounts paid by Petra or its Sublicensee pursuant to the applicable Third Party license agreement from any amounts due to Takeda pursuant to <u>Section 5.6</u>. Notwithstanding the foregoing, under no circumstances shall the deductions under this <u>Section 5.7(a)</u> result in the amount payable to Takeda being reduced by [\*\*\*] compared with the amount otherwise payable for such Product as of such time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b) Generic Competition**. It with respect to a particular Product in a particular country in the Territory during a particular [\*\*\*], the Generic Competition Percentage is [\*\*\*], then the royalty rates set forth in <u>Section 5.6</u> for Net Sales of such Product in such country during such [\*\*\*] shall be reduced by [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(d) Minimum Royalty**. Notwithstanding anything in this Agreement express or implied to the contrary, none of the reductions to Royalty Payments provided in <u>Section 5.7(a)</u> and (b) above, will, in the aggregate, reduce the Royalty Payments payable with respect to Net Sales of any Product sold by Petra, its Affiliates and its Sublicensees in any country during the Term by more than [\*\*\*] of the Royalty Payments otherwise owed to Takeda.

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Exhibit 10.20

**5.8 Mode of Payment and Currency; Invoices**. All payments to Takeda hereunder shall be made by deposit of USD in the requisite amount to such bank account as Takeda may from time to time designate by written notice to Petra. With respect to amounts payable hereunder not denominated in USD, Petra shall convert applicable amounts in foreign currency into USD by using an exchange rate equal to [\*\*\*]. Based on the resulting sales in USD, the then-applicable royalties shall be calculated. The Parties may vary the method of payment set forth herein at any time upon mutual written agreement, and any change shall be consistent with the local Law at the place of payment or remittance.

**5.9 Reports and Records Retention**. Within [\*\*\*], Petra shall deliver to Takeda, together with the applicable payment of the associated Royalty Payment, a written report ("**Royalty Report**"), on a Product-by-Product, country-by-country basis, summarizing the total amount of Net Sales during such Calendar Quarter, the exchange rates used in converting Net Sales to USD, and details on a country-by-country basis of any deductions or reductions and the calculation of the Royalty Payment. Each Royalty Report shall be deemed Confidential Information of Petra subject to the obligations of Article 7 of this Agreement. For at least [\*\*\*], Petra shall keep complete and accurate records of such Net Sales in sufficient detail to confirm the accuracy of the calculations hereunder.

**5.10 Late Payments**. All payments under this Agreement which are not disputed in good faith by Petra shall earn interest from the date due until paid at a rate equal to the lesser of (a) the maximum rate permissible under Law and (b) one [\*\*\*].

**5.11 Audits.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a) Audits Generally**. During the Term and for [\*\*\*], and not more than [\*\*\*] in each Calendar Year, Petra shall permit an independent certified public accounting firm of nationally recognized standing selected by Takeda to have access to and to review, during normal business hours upon reasonable prior written notice, the applicable records of Petra to verify the accuracy of the Royalty Reports and payments under this Article 5. Such review may cover the records for sales made in any Calendar Year ending not more than [\*\*\*] prior to the date of such request. The accounting firm shall disclose to Takeda and Petra only whether the Royalty Reports are correct or incorrect and the specific details concerning any discrepancies.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b) Audit-Based Reconciliation**. If such accounting firm concludes that additional amounts were owed during such period, Petra shall pay the additional undisputed amount [\*\*\*], within [\*\*\*]. If such accounting firm concludes that an overpayment was made, such overpayment shall be fully creditable against amounts payable in subsequent payment periods. If Petra disagrees with such calculation, it may, [\*\*\*], retain its own independent certified public accounting firm of recognized standing and reasonably acceptable to Takeda, to conduct a review, and if such firm concurs with the other accounting firm, Petra shall make the required payment within [\*\*\*]. Takeda shall pay for the cost of its auditor, unless Petra has underpaid Takeda by [\*\*\*] or more for the audited period, in which case Petra shall reimburse Takeda for all out-of-pocket costs and expenses associated with the audit.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c) Audit Confidentiality**. Each Party shall treat all information that it receives under this <u>Section 5.11</u> in accordance with the confidentiality provisions of Article 7 of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the other Party obligating such firm to retain all such financial information in confidence pursuant to such confidentiality agreement, except to the extent necessary for Takeda to enforce its rights under this Agreement.

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Exhibit 10.20

**5.12 Taxes.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a) Withholding Tax**. The amounts payable pursuant to this Agreement ("**Payments**") shall not be reduced on account of any Taxes unless required by applicable Law. Petra shall deduct and withhold from the Payments any Taxes that it is required by applicable Law to deduct or withhold. Notwithstanding the foregoing, if Takeda is entitled under any applicable tax treaty to a reduction of rate of, or the elimination of, or recovery of, applicable withholding tax, it may deliver to Petra or the appropriate governmental authority the prescribed forms necessary to reduce the applicable rate of withholding or to relieve Petra of its obligation to withhold tax. In such case, Petra shall apply the reduced rate of withholding, or not withhold, as the case may be, provided that Petra is in receipt of evidence, in a form reasonably satisfactory to Petra, for example Takeda's delivery of all applicable documentation at least [\*\*\*]. If, in accordance with the foregoing, Petra withholds any amount, it shall pay to Takeda the balance when due, make timely payment to the proper taxing authority of the withheld amount, and send Takeda proof of such payment within [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b) Value Added Tax**. It is understood and agreed between the Parties that VAT and any similar Tax imposed upon payments by Petra to Takeda shall be the responsibility of Takeda. Takeda shall file (with Petra reasonable cooperation) all required Tax returns, ensure all VAT and similar Taxes are paid, and provide evidence of such to Petra on a timely basis following each such payment.

**Article 6**<br>**INVENTIONS AND PATENTS**

**6.1 Drug Price Competition and Patent Restoration Act**. Each Party shall promptly give written notice to the other Party of any certification of which it becomes aware filed pursuant to 21 U.S.C. Section 355(b)(2)(A) (or any amendment or successor statute thereto) claiming that any Takeda Patents covering any Licensed Compounds or any Product, or the manufacture or use of any of the foregoing, are invalid or unenforceable, or that infringement will not arise from the manufacture, use or sale of a Product by a Third Party.

**6.2 Listing of Patents**. Petra shall have the sole right to determine which of the Takeda Patents, if any, shall be listed for inclusion in the Approved Drug Products with Therapeutic Equivalence Evaluations pursuant to 21 U.S.C. Section 355, or any successor Law in the United States, together with any comparable Laws in any other country in the Territory.

**6.3 Patent Prosecution and Maintenance.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a) Takeda Patents**. Petra shall have the first right, but not the obligation (subject to <u>Section 6.3(b)</u>), to file, prosecute and maintain Takeda Patents in Takeda's name, on a worldwide basis. As between the Parties, [\*\*\*]. Petra shall keep Takeda reasonably informed of the status of the filing and prosecution of Takeda Patents or related proceedings including any material communications with any patent office or patent authority having jurisdiction over a patent or patent application in connection with pre- and post-grant proceedings (e.g., interferences, oppositions, reexaminations, reissues, revocations or nullifications) in a timely manner. Promptly after the Effective Date, Takeda shall deliver to Petra all prosecution and maintenance files associated with the Takeda Patents, in accordance with <u>Section 2.6</u>. Petra may request that Takeda make its employees, agents and service providers available to Petra to help enable Petra to continue prosecution or maintenance of any such Takeda Patents in such country, [\*\*\*].

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Exhibit 10.20

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b) Election Not to File and Prosecute Takeda Patents**. If Petra elects not to continue to prosecute or maintain a Takeda Patent in Takeda's name in any country in the Territory, then it shall notify Takeda in writing at least [\*\*\*], as the case may be, or [\*\*\*], as the case may be. In such case, Takeda shall have the right to support the continued prosecution or maintenance of such Takeda Patent in that country. If Takeda elects to continue prosecution or maintenance of any such Takeda Patent, then Petra shall promptly deliver to Takeda all prosecution files associated with such Takeda Patent and use reasonable efforts to make its employees, agents and consultants reasonably available to Takeda, at no cost to Takeda, to the extent reasonably necessary to enable Takeda to continue prosecution or maintenance of any such Takeda Patent.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c) Patent Term Extension**. Petra shall be responsible, in Takeda's name, on a worldwide basis, for making decisions regarding and obtaining patent term extensions wherever available for Takeda Patents. In the event that any election with respect to obtaining patent term extensions is to be made, Petra shall have the right to make such elections. Petra shall keep Takeda informed of the status of any efforts regarding patent term extensions in a timely manner and shall provide Takeda with any material communications related thereto.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(d) Petra Patents**. Petra and its Sublicensees shall own any Know-How developed solely by them or a Third Party on behalf of them and shall have the right, but not the obligation, to file, prosecute and maintain Patent Rights covering or claiming any such Know-How (collectively, "**Petra Patents**"). [\*\*\*].

**6.4 Enforcement of Patents.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a) Notice**. If either becomes aware of any infringement or ownership claim or threatened infringement claim with respect to the Takeda Patents, or if a Third Party claims that any Takeda Patent is invalid or unenforceable anywhere in the Territory (any such activity, a "**Third Party Infringement**"), the Party possessing such knowledge or belief shall promptly notify the other Party and provide it with details of such Third Party Infringement that are known by such Party.

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Exhibit 10.20

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c) Costs of an Action**. Without limiting the respective indemnity obligations of the Parties set forth in Article 9, and except for [\*\*\*], [\*\*\*] shall pay [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(d) Settlement**. Neither Party shall settle or otherwise compromise any Action by admitting that any Takeda Patent is invalid or unenforceable without the other Party's prior written consent, and neither Party shall settle or otherwise compromise an Action in a way that adversely affects or would be reasonably expected to materially adversely affect the validity or enforceability of the Takeda Patents or the rights or benefits of the other Party hereunder, without the other Party's prior written consent. The foregoing shall not limit Petra's rights under <u>Section 6.4(b)</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(e) Distribution of Amounts Recovered**. Any amounts recovered by the Party taking an Action pursuant to this <u>Section 6.4</u>, whether by settlement or judgment, shall be allocated in the following order: [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(f) Petra Patents**. Petra shall have the sole right and authority. but not the obligation, to enforce Petra Patents against any Third Party infringer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(g) Delegation of Enforcement Rights**. Petra shall have the right, in its sole discretion, to delegate its rights under this <u>Section 6.4</u>, in whole or in part, to one or more Sublicensees, provided that any such Sublicensee shall comply with the terms of this <u>Section 6.4</u>.

**6.5 Challenge**. If Petra, or any of Petra's Sublicensees, directly, or indirectly, commences any interference or opposition proceeding, challenges the validity or enforceability of, or opposes any extension of or the grant of a supplementary protection certificate, in each case, with respect to any Takeda Patent in a given country (each such action, a "**Patent Challenge**"), Takeda shall have the right to terminate this Agreement in its entirety if Petra or its Sublicensee fails to withdraw such Patent Challenge within [\*\*\*]; provided however that such right to terminate shall not apply to any controlling Affiliate of Petra that first becomes an Affiliate of Petra after the Effective Date where such Affiliate was undertaking activities in connection with a Patent Challenge prior to becoming such an Affiliate; *provided, however*, that Petra causes such Patent Challenge to terminate within [\*\*\*]. For the avoidance of doubt, an action by Petra in accordance with <u>Section 6.3</u> to amend claims within a pending patent application of the Takeda Patents or in defense of a Third Party Infringement shall not constitute a challenge under this <u>Section 6.5</u>.

**Article 7**<br>**CONFIDENTIALITY**

**7.1 Confidentiality Obligations**. Each Party (the "**Receiving Party**") agrees that, for the Term and for [\*\*\*] thereafter, such Party shall, and shall ensure that its Affiliates and its and its Affiliates' employees, consultants, Sublicensees, contractors, advisors and agents (collectively, "**Receiving Party Representatives**") shall, (a) hold in strict confidence all Confidential Information disclosed to it by the other Party (the "**Disclosing Party**") pursuant to this Agreement and (b) not use such Confidential Information for any purpose except those permitted by this Agreement (it being understood that this <u>Section 7.1</u> shall not create or imply any rights or licenses not expressly granted under this Agreement), unless such information:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)** is approved in writing by the Disclosing Party for release or use by the Receiving Party without restriction, but only from the time such Confidential Information is approved for release and thereafter;

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Exhibit 10.20

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** is part of the public domain at the time of disclosure to the Receiving Party or becomes part of the public domain through no wrongful act or intentional failure to act of the Receiving Party or its Affiliates, but only from the time such Confidential Information becomes available to the public or otherwise part of the public domain and thereafter;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c)** is in the Receiving Party's possession without any confidentiality obligation or use restriction at the time of disclosure by the Disclosing Party, as the Receiving Party can, by competent proof demonstrate, other than as a result of any prior confidential disclosure by the Disclosing Party;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(d)** was disclosed to the Receiving Party by a Third Party having no duty of confidentiality to the Disclosing Party with respect to such Confidential information and having the legal right to disclose such Confidential Information, but only from the time such Confidential Information was so rightfully disclosed and thereafter; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(e)** is independently developed by the Receiving Party or its Affiliates, as the Receiving Party can, by competent proof, demonstrate, by persons in its employ or consultants who have had, directly or indirectly, no contact with or exposure to Confidential Information received hereunder, but only from the time such Confidential Information was independently developed and thereafter.

The Receiving Party shall not disclose any of the Confidential Information, except to Representatives of the Receiving Party who need to know the Confidential Information for the purpose of performing the Receiving Party's obligations, or to assist Receiving Party in exercising its rights, under this Agreement and who are bound by written obligations of non-use and non-disclosure at least as protective of the Disclosing Party those set forth herein. The Receiving Party shall be responsible for any disclosure or use of the Confidential Information by such Receiving Party Representatives. The Receiving Party shall protect Confidential Information using not less than the same care with which it treats its own confidential information, but at all times shall use at least reasonable care. Notwithstanding the foregoing, unless and until this Agreement is terminated, the Takeda Know-How shall be deemed to be the Confidential Information of both Takeda and Petra and each Party shall be the Receiving Party with respect thereto and subject to the obligations set forth under this Article 7, it being understood that (a) Petra shall have all rights to use such Takeda Know-How consistent with its rights and licenses under this Agreement and (b) Takeda shall have all rights to use such Takeda Know-How consistent with its rights and licenses under <u>Section 2.2</u> above.

**7.2 Authorized Disclosure and Use**. Notwithstanding <u>Section 7.1</u>, a Receiving Party may use or disclose the Confidential Information of the Disclosing Party for the purpose of performing its obligations, or exercising its rights, under this Agreement, including for purposes of:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)** filing or prosecuting patent applications or enforcing patents, pursuant to the terms of <u>Section 6.3</u> and <u>Section 6.4</u>;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** prosecuting or defending litigation, including responding to a subpoena in a Third Party litigation;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c)** conducting pre-clinical studies or clinical trials pursuant to this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(d)** seeking or maintaining any regulatory filings or Regulatory Approval of any Product; or

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Exhibit 10.20

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(e)** complying with Law, including securities Law and the rules of any securities exchange or market on which a Party's securities are listed or traded.

In addition to the foregoing, Petra may disclose Confidential Information of Takeda to Petra's and its Affiliates' Sublicensees (if such Sublicensee has been sublicensed by Petra in compliance with <u>Section 2.4</u>), each of which, prior to disclosure, must be bound by written obligations of confidentiality and non-use at least as protective of Takeda's rights as those set forth in this Article 7. Furthermore, the Receiving Party may disclose (a) the Disclosing Party's Confidential Information to its Affiliates, employees, consultants, agents and (b) on a need-to-know basis, the terms and conditions of this Agreement to actual or potential acquirers, investors, partners, financing sources, and/or financial advisors, each of whom, pursuant to clauses (a) and (b) above, prior to disclosure must be bound by written obligations of confidentiality and non-use at least as protective of the Disclosing Party's rights as those set forth in this Article 7; [\*\*\*]. The Receiving Party shall be responsible for any disclosure or use of the Confidential Information by such Persons to whom it discloses Confidential Information pursuant to this paragraph.

If either Party proposes to file with the SEC or the securities regulators of any state or other jurisdiction a registration statement or any other disclosure document that describes or refers to the terms and conditions of, or includes a copy of, this Agreement under the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, or any other applicable securities law, such Party will notify the other Party of such intention and will provide such other Party with a copy of relevant portions of the proposed filing a reasonable time (but at least ten [\*\*\*] (and any material revisions to such portions of the proposed filing a reasonable time (but at least [\*\*\*]), including any exhibits thereto disclosing the terms or conditions of this Agreement, and will use reasonable and diligent efforts to seek confidential treatment of the terms and conditions of this Agreement that such other Party requests be kept confidential, and will only disclose such terms and conditions of this Agreement that it is advised by counsel are legally required to be disclosed. No such notice will be required under this <u>Section 7.2</u> if the description of or reference to this Agreement contained in the proposed filing has been included in any previous filing made by the other Party hereunder or otherwise approved by the other Party.

**7.3 Required Disclosure**. The receiving Party may disclose the Confidential Information to the extent required by Law or court order; provided, however, that the receiving Party promptly provides to the disclosing party prior written notice of such disclosure and provides reasonable assistance to the disclosing party in obtaining an order or other remedy protecting the Confidential Information from public disclosure.

**7.4 Publications**. Takeda shall submit to Petra for Petra's written approval (which approval may be granted or denied in Petra's sole discretion) any publication or presentation (including in any seminars, symposia or otherwise) of information related directly to the Licensed Compounds or any Product for review and approval at least [\*\*\*]; provided that Takeda shall have the right, without Petra's written approval, to publish or otherwise publicly present the results of any non-clinical research relating to the Licensed Compounds conducted by Takeda prior to the Effective Date. Petra shall have the right to make such publications regarding Development or Commercialization of Licensed Compounds or Product as it chooses, in its sole discretion, without the approval of Takeda, provided such publication does not contain any Confidential Information of Takeda (other than the Takeda Know-How), if approval of Takeda is required pursuant to this Section, Takeda shall not unreasonably withhold or condition such approval, and shall provide such approval or rejection of the applicable publication within [\*\*\*]. If Takeda rejects the applicable publication, then in connection with such rejection, Takeda shall specify what Confidential information of Takeda is included in such publication and where such Confidential Information is included.

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Exhibit 10.20

**7.5 Public Disclosures**. Neither Party may issue a press release or other public statement, whether oral or written, disclosing the existence of this Agreement, the terms hereof, or any information relating hereto without the prior written consent of the other Party, except as otherwise provided for in this Article 7. Notwithstanding the foregoing, each Party may make any disclosures required of it to comply with any duty of disclosure it may have under relevant Laws. In the event of a disclosure required by Law, the Parties will coordinate with each other with respect to the timing, form and content of such required disclosure. Subject to the foregoing sentence, Petra shall have the right to make press releases or public announcements regarding the Development and/or Commercialization of any Licensed Compounds and Products, and in connection with which acknowledge (subject to <u>Section 12.5</u>) that the Licensed Compounds and/or Product(s) were licensed in from an unaffiliated entity (without naming Takeda), without the prior written consent of Takeda. In addition, if a public securities filing under <u>Section 7.2</u> has been made, or a press release or other public statement has been issued or made, in which it was stated that a Licensed Compound and/or Product was licensed in from Takeda, then Petra shall have the right to restate such already publicized information contained in the public securities filing and/or press release or other public statement, without the prior written consent of Takeda.

**Article 8**<br>**REPRESENTATIONS AND WARRANTIES**

**8.1 Mutual Representations and Warranties**. Each Party represents and warrants that, as of the Effective Date:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)** such Party is duly organized and validly existing under the Laws of the jurisdiction of its incorporation or organization;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** such Party has taken all action necessary to authorize the execution and delivery of this Agreement and the performance of its obligations under this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c)** this Agreement is a legal and valid obligation of such Party, binding upon such Party and enforceable against such Party in accordance with the terms of this Agreement, except as enforcement may be limited by applicable bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting creditors' rights generally and by general equitable principles;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(d)** the execution, delivery and performance of this Agreement by such Party does not conflict with, breach or create in any Third Party the right to accelerate, terminate or modify any agreement or instrument, including any policy, procedure or rule, to which such Party (or any officer or director of such Party) is a party or by which such Party (or such individual) is bound, and does not violate any Law of any Governmental Body having authority over such Party (or such individual); and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(e)** such Party has all right, power and authority to enter into this Agreement and to perform its obligations under this Agreement.

**8.2 Takeda Representations and Warranties**. Takeda represents and warrants that, as of the Effective Date:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)** no consent by any Third Party or Governmental Body is required with respect to the execution and delivery of this Agreement by it or the consummation by it of the transactions contemplated hereby.

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Exhibit 10.20

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** no claims have been asserted against it, or, to its knowledge, threatened (without independent investigation or inquiry), by any Person (i) challenging the validity, enforceability, effectiveness, or ownership of any of the Takeda Patents listed on <u>Exhibit C</u>, or (ii) that the use, manufacture, Development, or Commercialization of any Licensed Compound, each in its form as of the Effective Date, infringes or will infringe on any Patent Rights or other intellectual property right of any Person;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c)** none of the Takeda Patents are the subject of any litigation procedure, discovery process, interference, reissue, reexamination, opposition, appeal proceedings or any other legal dispute;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(d)** Takeda has sole and exclusive Control of the entire right, title and interest in and to the Takeda Technology, and the Takeda Technology is free and clear of any liens, charges, encumbrances or rights of others to possession or use in the Field in the Territory;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(e)** neither it nor any of its Affiliates has employed or otherwise used in any capacity the services of any Person debarred under United States law, including under Section 21 U.S.C. Section 335a or any foreign equivalent thereof, with respect to any Development of any Licensed Compound; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(f)** Takeda Controls all right, title and interest in and to the Regulatory Materials to be assigned to Petra hereunder, and to Takeda's knowledge, Takeda and its Affiliates have generated, prepared, maintained, and retained all material Regulatory Materials in the Field that are required to be maintained or retained pursuant to and in accordance with GCP, GLP and other applicable Law, and all such information is true, complete and correct in all material respects and what it purports to be.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(g)** to Takeda's knowledge, without independent inquiry, the patents and patent applications listed in Exhibit C are the sole patents and patent applications Controlled by Takeda or its Affiliates as of the Effective Date that claim the composition of matter of TAK-117 [\*\*\*], [\*\*\*], or [\*\*\*].

**8.3 WAIVER OF ALL OTHER REPRESENTATIONS AND WARRANTIES. EXCEPT AS PROVIDED IN <u>SECTIONS 8.1</u> AND <u>8.2</u> OR ELSEWHERE IN THIS AGREEMENT, THE LICENSED COMPOUNDS AND THE TAKEDA TECHNOLOGY ARE PROVIDED AS-IS. EXCEPT AS PROVIDED IN <u>SECTIONS 8.1</u> AND <u>8.2</u>, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, OF ANY KIND, IN PARTICULAR, EXCEPT AS PROVIDED IN <u>SECTIONS 8.1</u> AND <u>8.2</u>, TAKEDA DISCLAIMS ANY WARRANTY WITH RESPECT TO THE TAKEDA TECHNOLOGY, THE INVENTION(S) CLAIMED IN THE TAKEDA PATENTS OR WITH RESPECT TO THE TAKEDA PATENTS THEMSELVES, INCLUDING BUT NOT LIMITED TO, ANY REPRESENTATIONS OR WARRANTIES ABOUT (I) THE VALIDITY, SCOPE OR ENFORCEABILITY OF ANY OF THE TAKEDA PATENTS; (II) THE ACCURACY, SAFETY OR USEFULNESS FOR ANY PURPOSE OF ANY INFORMATION PROVIDED BY EITHER PARTY, WITH RESPECT TO THE INVENTIONS) CLAIMED IN THE TAKEDA PATENTS OR WITH RESPECT TO THE TAKEDA PATENTS THEMSELVES AND ANY PRODUCTS DEVELOPED FROM OR COVERED BY THEM; (III) WHETHER THE PRACTICE OF ANY CLAIM CONTAINED IN ANY OF THE TAKEDA PATENTS WILL OR MIGHT INFRINGE A PATENT OR OTHER INTELLECTUAL PROPERTY RIGHT OWNED OR LICENSED BY A THIRD PARTY; (IV) THE PATENTABILITY OF ANY INVENTION CLAIMED IN THE TAKEDA PATENTS; OR (V) THE ACCURACY, SAFETY, OR USEFULNESS FOR ANY PURPOSE OF THE INFORMATION CONTAINED IN THE TAKEDA PATENTS OR THE TAKEDA KNOW-HOW OR ANY** 

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Exhibit 10.20

**PRODUCT OR PROCESS MADE OR CARRIED OUT IN ACCORDANCE WITH OR THROUGH THE USE OF THE TAKEDA PATENTS. IN ADDITION, EXCEPT AS PROVIDED IN <u>SECTIONS 8.1</u> AND <u>8.2</u>, TAKEDA SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, AND THE ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE.**

**Article 9**<br>**INDEMNIFICATION AND INSURANCE**

**9.1 Indemnification by Petra**. Petra shall indemnify, defend and hold Takeda and its Affiliates and each of their respective employees, officers, directors and agents (the "**Takeda Indemnitees**") harmless from and against any and all liability, claims, damage, loss, cost or expense of any kind or nature (including reasonable attorneys' fees) payable to a Third Party claimant based on, arising out of or otherwise relating to from any claims, suits, proceedings or causes of action brought by such Third Party to the extent arising from the activities of Petra, its subcontractors or Sublicensees under this Agreement (including product liability claims); provided, however, that Petra's obligations pursuant to this <u>Section 9.1</u> shall be reduced to the extent such claims or suits are determined with finality by a court of competent jurisdiction or a dispute resolution mechanism to be directly attributable to the negligence or willful misconduct of, or any breaches of this Agreement (including any representations and warranties set forth in Article 8) by, any of the Takeda Indemnitees.

**9.2 Indemnification by Takeda**. Takeda shall indemnify, defend and hold Petra and its Affiliates and each of their respective employees, officers, directors and agents (the "**Petra Indemnitees**") harmless from and against any and all liability, claims, damage, loss, cost or expense of any kind or nature (including reasonable attorneys' fees) payable to a Third Party claimant based on, arising out of or otherwise relating to from any claims, suits, proceedings or causes of action brought by such Third Party to the extent arising from (a) the negligence or willful misconduct of any Takeda Indemnitee; (b) any breach of any provision of this Agreement by Takeda or any other Takeda Indemnitee (including any representations and warranties set forth in Article 8): or (c) the use of any Licensed Compound or the Product by Takeda or its Affiliates prior to the Effective Date: *provided, however*, that Takeda's obligations pursuant to this <u>Section 9.2</u> shall be reduced to the extent such claims or suits are determined with finality by a court of competent jurisdiction or a dispute resolution mechanism to be directly attributable to the negligence or willful misconduct of, or any breaches of this Agreement (including any representations and warranties set forth in Article 8) by any of the Petra Indemnitees.

**9.3 Notification of Claims; Conditions to Indemnification Obligations**. As a condition to a Party (the "**Indemnified Party**") having the right to receive indemnification from the Party from whom the indemnified Party is entitled to receive indemnification under this Article 9 (the "**Indemnifying Party**"), such Indemnified Party shall: (a) promptly notify the Indemnifying Party as soon as it becomes aware of a claim or suit for which indemnification may be sought pursuant hereto; (b) cooperate, and cause the individual indemnitees to cooperate, with the Indemnifying Party in the defense, settlement or compromise of such claim or suit; and (c) permit the Indemnifying Party to control the defense, settlement or compromise of such claim or suit, including the right to select defense counsel (*provided, however*, that, without limiting the foregoing, Takeda may engage its own defense counsel at its own expense). In no event, however, may the Indemnifying Party (a) compromise or settle any claim or suit in a manner which admits fault or negligence on the part of the Indemnified Party or, as applicable, any Takeda Indemnitee or Petra Indemnitee (each, an "**Indemnitee**"), (b) require any omission or impose any obligation on the part of the Indemnified Party or applicable Indemnitee, or (c) otherwise have an adverse effect on the rights or interest of

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Exhibit 10.20

the Indemnified Party or applicable Indemnitee, in each case without the prior written consent of the Indemnified Party, which consent shall not be unreasonably withheld, delayed or conditioned. Each Party shall reasonably cooperate with the other Party and its counsel in the course of the defense of any such suit, claim or demand, such cooperation to include using reasonable efforts to provide or make available documents, information and witnesses.

**9.4 Insurance**. During the Term, Petra shall obtain and maintain, at its sole cost and expense, Third Party insurance in types and amounts that are reasonable and customary in the United States pharmaceutical and biotechnology industry for companies engaged in comparable activities and that are sufficient to cover any indemnification claim by Takeda or the Takeda Indemnitees hereunder. It is understood and agreed that this insurance shall not be construed to limit Petra's liability with respect to its indemnification obligations hereunder or otherwise. Petra will provide to Takeda upon request a certificate evidencing such insurance. The foregoing coverage shall continue during the term of this Agreement and for a period of [\*\*\*]. Without limiting the generality of the foregoing, during any period in which Petra conducts clinical trials, and for a period of [\*\*\*], Petra shall have a clinical trial liability policy covering product liability claims with at least [\*\*\*]. Petra shall also maintain general liability insurance with at least [\*\*\*] and, any time a Product is being Commercialized, a Commercially Reasonable amount of product liability insurance. In all cases, Petra shall increase the amounts of insurance as necessary to provide coverage for its clinical trials Development and Commercialization as appropriate to be consistent with then-current industry standards.

**9.5 Waiver**. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, EXCEPT TAKEDA SHALL NOT BE RESPONSIBLE OR HAVE LIABILITY FOR, ANY INJURY, LOSS OR DAMAGE OF ANY KIND SUSTAINED BY PETRA OR A THIRD PARTY, INCLUDING BUT NOT LIMITED TO DIRECT, INDIRECT, SPECIAL, PUNITIVE, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OR LOST PROFITS OR LOST REVENUES REGARDLESS OF THE LEGAL THEORY AND REGARDLESS OF WHETHER TAKEDA WAS INFORMED OF THE POSSIBILITY OF SUCH DAMAGES.

**Article 10**<br>**TERM AND TERMINATION**

**10.1 Term and Expiration**. The term of this Agreement (the "**Term**") shall commence on the Effective Date and, unless earlier terminated as provided in this Article 10, shall continue in full force and effect, on a country-by-country and Product-by-Product basis until the date on which the Royalty Term in such country with respect to such Product expires, at which time this Agreement shall expire with respect to such Product in such country and the terms of <u>Section 10.3(b)(i)</u> shall apply. This Agreement shall expire in its entirety upon the expiration of the last-to-expire Royalty Term with respect all Products, and the terms of <u>Section 10.3</u> shall apply.

**10.2 Termination**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a) Material Breach**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) If either Party breaches any of its material obligations under this Agreement (including, [\*\*\*]), the other Party may give to the breaching Party a written notice specifying the nature of the default and describing it in reasonable detail, requiring it to cure such breach, and stating its intention to terminate this Agreement if such breach is not cured within [\*\*\*]. If such breach is not cured within [\*\*\*], the non-breaching Party shall be entitled to terminate this Agreement immediately by written notice to the breaching Party. For clarity, each Party's material

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Exhibit 10.20

obligations may apply to the performance of either: (i) this Agreement in its entirety, in which case this provision shall apply to the entire Agreement; or (ii) a specific Product(s) or country(ies), in which case this provision shall apply only to such affected Product(s) or country(ies).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) Any dispute regarding an alleged breach of this Agreement or willful misconduct in performance of obligations under this Agreement shall be resolved in accordance with Article 11 hereof. Notwithstanding anything to the contrary contained in this <u>Section 10.2</u> or elsewhere in the Agreement, the applicable cure period for any alleged breach or willful misconduct that is in dispute shall be tolled from the date that the alleged breaching Party notifies the other Party that it intends to dispute the allegation through the resolution of such dispute pursuant to Article 11 and it is understood and acknowledged that, during the pendency of a dispute pursuant to Article 11, all of the terms and conditions of this Agreement shall remain in effect, and the Parties shall continue to perform all of their respective obligations under this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** [**\*\*\***]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c) Bankruptcy**. To the extent permitted under applicable law, either Party may terminate this Agreement in its entirety upon providing written notice to the other Party in the event that such other Party becomes insolvent, files or has filed against it a petition under any bankruptcy law, or makes an assignment of all or substantially all of its assets for the benefit of its creditors.

**10.3 Effects of Termination**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a) Survival**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) Notwithstanding the expiration or termination of this Agreement pursuant to <u>Section 10.1</u> or <u>Section 10.2</u>, the following provisions shall survive: <u>1</u>, <u>5.9</u> (last sentence only), <u>6.3(d)</u>, 7.9 (other than <u>Section 9.4</u>), <u>10</u>, <u>11</u> and <u>12</u>. In addition. <u>Section 6.4</u> shall survive any expiration of the Agreement with respect to a Product in a particular country following the expiration of the Royalty Term with respect to such Product in such country, but only for so long as such Product continues to be Commercialized by or on behalf of Petra or any of its Sublicensees.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) Expiration or termination of this Agreement shall not relieve the Parties of any obligation or liability that accrued hereunder prior to the effective date of such expiration or termination. In addition, except for the termination events addressed in <u>Section 10.2(b)</u>, termination of this Agreement shall not preclude either Party from pursuing all rights and remedies it may have hereunder or at Law or in equity with respect to any breach of this Agreement nor prejudice either Party's right to obtain performance of any obligation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii) All of the effects of termination are in addition to the other rights and remedies that may be available to either of the Parties under this Agreement and shall not be construed to limit any such rights or remedies. In the event this Agreement is not terminated in its entirety, but rather is terminated on a Product-by-Product and country-by-country basis with respect to one or more Products (the "**Terminated Product**") in a particular country (the "**Terminated Country**"), then, notwithstanding anything to the contrary contained in <u>Sections 10.3(a)(i)</u> or <u>10.3(a)(ii)</u>, the consequences of termination described under this <u>Section 10.3</u> shall only apply to the Terminated Product in the Terminated Country, and this Agreement shall remain in full force and effect in accordance with its terms with respect to all Products other than the Terminated Products, and in all countries of the Territory other than the Terminated Countries. For clarity, a Terminated Product may be a Licensed Compound or Product that was not approved by the Company to be further studied.

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Exhibit 10.20

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b) Licenses**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) As of the effective date of expiration (but not an early termination) of the Royalty Term with respect to a given Product and country, the licenses from Takeda to Petra under <u>Section 2.1</u> shall convert to fully paid, royalty-free, irrevocable, and perpetual licenses. For clarity, all of Petra's rights under this Agreement which are necessary for Petra's exercise of the foregoing license will remain in effect following any such expiration of a Royalty Term.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) Upon termination of this Agreement by Petra or Takeda pursuant to <u>Section 10.2(a)</u>, the following terms and conditions shall apply only with respect to such Product(s) and country(ies) as are the subject of such termination:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) all licenses granted to Petra under <u>Section 2.1</u> shall terminate (except to the extent reasonably necessary to provide the transition described herein);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) Petra and its Sublicensees shall be entitled, during the [\*\*\*] period following such termination, to sell any commercial inventory of such Product(s) which remains on hand as of the date of the termination, so long as Petra makes all Royalty Payments in accordance with the terms and conditions set forth in this Agreement. At the conclusion of such [\*\*\*] period, any commercial inventory remaining shall be offered for sale to Takeda at a price [\*\*\*], as applicable (provided that Takeda shall have no obligation to purchase such inventory), and any quantities of Licensed Compound(s) that remain in Petra's possession shall be returned to Takeda [\*\*\*]; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(3) Each Party shall return or destroy, at the other Party's election, all Confidential Information of the other Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii) Upon any termination of this Agreement by Petra pursuant to <u>Section 10.2(a)</u> (material breach by Takeda), Takeda shall offer each Sublicensee granted a sublicense that is in effect on the effective date of termination of Licensee's license rights under this Agreement the right to enter into a license agreement directly with Takeda on substantially the same terms and conditions under which such rights and licenses were granted to such; *provided, however*, that (a) such Sublicensee is not then in material breach of any of its material obligations under its sublicense agreement; (b) such Sublicensee agrees to comply with all the terms of this Agreement to the extent applicable to the rights sublicensed to it by Licensee or its Affiliate as though it were Petra; and (c) Takeda shall have no obligations under such sublicense agreement beyond the obligations expressly set forth in this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv) Immediately following Petra's notification of termination to Takeda pursuant to <u>Section 10.2(a)</u>, (unless such termination by Petra for Takeda's breach is the subject of a good faith dispute), the diligence obligations in <u>Section 3.4</u> shall no longer apply and Petra shall have the right to wind-down all then on-going Development and/or Commercialization activities.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(v) In the event that Petra abandons Development and Commercialization of all Licensed Compounds and all Products containing any Licensed Compounds and Takeda elects to take back such Development and Commercialization in accordance with <u>Section 3.8</u>, the Parties will negotiate in good faith the terms of (A) an exclusive, worldwide, royalty-bearing, sublicensable license under any Know-How or Patent Rights owned or Controlled by Petra or its Affiliates that is related to any Product(s) and/or (B) a non-exclusive, worldwide, royalty-bearing, sublicensable license under any Know-How or Patent Rights owned or Controlled by Petra or its Affiliates that is

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Exhibit 10.20

necessary or useful for the Development, Commercialization or other Exploitation of the Products (such intellectual property described in (A) and (B) is the "**Petra Technology**"), in each case for the limited purpose of Developing, Commercializing and otherwise Exploiting Products. In each case, the terms of any such license agreement will include commercially reasonable financial consideration payable to Petra (including potential milestones and royalty payments) as consideration for such license(s), which will take into account, among other things, [\*\*\*]. For the avoidance of doubt, Petra's obligation pursuant to this subsection (v) is limited to good faith negotiation of a potential license, and does not create an obligation to actually so license such Petra Technology to Takeda.

**10.4 Effects of Bankruptcy or Insolvency**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a) Bankruptcy Code**. All rights and licenses granted under or pursuant to this Agreement by Takeda are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the US Bankruptcy Code, if applicable, licenses of rights to "intellectual property" as defined under Section 101 of the US Bankruptcy Code.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b) Continuing Rights**. The Parties agree that Petra, as licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the US Bankruptcy Code. The Parties further agree that, in the event of any Takeda Bankruptcy Event, Petra shall be entitled to a complete duplicate of (or complete access to, as appropriate) any Takeda Know-How and all embodiments thereof, which, if not already in Petra's possession, shall be promptly delivered to it (i) following any such commencement of a bankruptcy proceeding upon Petra's written request therefor, unless Takeda elects to continue to perform all of its obligations under this Agreement or (ii) if not delivered under clause (i), following the rejection of this Agreement by Takeda upon written request therefor by Petra.

**Article 11**<br>**DISPUTE RESOLUTION**

**11.1 Disputes**. The Parties agree that the procedures set forth in this Article 11 shall be the exclusive mechanism for resolving any dispute, controversy, or claim between the Parties that may arise from time to time pursuant to this Agreement relating to either Party's rights or obligations hereunder (each, a "<u>Dispute</u>", and collectively, the "<u>Disputes</u>") that is not resolved through good faith negotiation between the Parties. For clarity, a Dispute hereunder does not include any disputes relating to matters for which Petra has sole decision-making authority and/or discretion under this Agreement (each, a "**Non-Escalatable Dispute**"), and such matter shall be determined by Petra and shall not be part of the dispute resolution procedure set forth in this Article 11. In the event that the Parties are unable to resolve any Dispute through diligent review and deliberation within [\*\*\*], then either Party shall have the right to escalate such matter to the management of the Parties as set forth in <u>Section 11.2</u>.

**11.2 Escalation to Management**. Either Party may, by written notice to the other Party, request that a Dispute that remains unresolved for a period of [\*\*\*] as set forth in <u>Section 11.1</u> arising between the Parties in connection with this Agreement, or a Dispute relating to alleged material breach, be resolved by the management of each Party (which, in the case of Takeda shall mean its [\*\*\*], and in the case of Petra shall means its [\*\*\*]), within [\*\*\*]. If management does not resolve such Dispute within [\*\*\*], then, at any time after such [\*\*\*], either Party may proceed to arbitration in accordance with <u>Section 11.3</u> with respect to such Dispute.

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Exhibit 10.20

**11.3 Arbitration**. Any Dispute not resolved pursuant to <u>Section 11.2</u> and excluding any Dispute, controversy or claim concerning the validity, enforceability, infringement or misappropriation of any intellectual property, shall be finally settled by binding arbitration conducted in the English language in [\*\*\*] under the commercial arbitration rules of the American Arbitration Association, which shall administer the arbitration and act as appointing authority. The arbitration will be conducted by a panel of [\*\*\*] arbitrators. Each Party will [\*\*\*]. Disputes about arbitration procedure shall be resolved by the arbitrators. The arbitrators shall not be current or former employees or directors, or current stockholders, of either Party or any of their respective Affiliates or Sublicensees and each arbitrator shall have at least [\*\*\*]. The arbitrators shall be authorized to grant interim relief, including to prevent the destruction of goods or documents involved in the Dispute, protect trade secrets and provide for security for a prospective monetary award. Within [\*\*\*], the arbitrators shall conduct the preliminary conference. In addressing any of the subjects within the scope of the preliminary conference, the arbitrators shall take into account both the desirability of making discovery efficient and cost-effective and the needs of the Parties for an understanding of any legitimate issue raised in the arbitration. In addition, each Party shall have the right to take up to [\*\*\*] of deposition testimony, including expert deposition testimony. The hearing shall commence within [\*\*\*]. The arbitrators shall, in their discretion, allow each Party to submit concise written statements of position and shall permit the submission of rebuttal statements, subject to reasonable limitations on the length of such statements to be established by the arbitrators. The hearing shall be no longer than [\*\*\*]. The arbitrators shall also permit the submission of expert reports. The arbitrators shall render their decision and award within [\*\*\*], and the decision and award shall include a written statement describing the essential findings and conclusions on which the decision and award are based, including the calculation of any damages awarded. The arbitrators will, in rendering their decision, apply the substantive law of the Commonwealth of Massachusetts, without reference to its conflict of laws principles. The decision and award rendered by the arbitrators shall be final, binding and non-appealable, and judgment may be entered upon it in any court of competent jurisdiction. [\*\*\*]. The parties acknowledge and agree that this Agreement and any award rendered pursuant hereto shall be governed by the UN Convention on the Recognition and Enforcement of Foreign Arbitral Awards.

**11.4 Injunctive Relief**. No provision herein shall be construed as precluding a Party from bringing an action for injunctive relief or other equitable relief in a court of competent jurisdiction prior to the initiation or completion of the above procedure.

**Article 12**<br>**MISCELLANEOUS PROVISIONS**

**12.1 Relationship of the Parties**. The Parties agree that they are and will be acting solely as independent contractors and nothing in this Agreement is intended or shall be deemed, for financial, tax, legal or other purposes, to constitute a partnership, agency, joint venture or employer-employee relationship between the Parties. Neither Party shall have any right, power or authority, nor shall they represent themselves as having any authority to assume, create or incur any expense, liability or obligation, express or implied, on behalf of the other Party, or otherwise act as an agent of the other Party for any purpose.

**12.2 Assignment**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a) Assignment by Petra**. Petra may assign this Agreement to any Affiliate or to any Third Party that acquires all or substantially all of the assets or business of Petra or to which this Agreement relates, whether by merger, sale of stock, sale of assets or other similar transaction, without the consent of Takeda. Petra shall give written notice to Takeda promptly following any

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Exhibit 10.20

such assignment. Except as expressly provided herein, neither this Agreement nor any interest hereunder shall be assignable or transferable by Petra, whether voluntarily or by operation of law, without the prior written consent of Takeda (such consent not to be unreasonably withheld or delayed).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b) Assignment by Takeda**. Takeda may assign this Agreement to any Affiliate or to any Third Party that acquires all or substantially all of the assets or business of Takeda, whether by merger, sale of stock, sale of assets or other similar transaction, without the consent of Petra. Takeda shall give written notice to Petra promptly following any such assignment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c) Continuing Obligations**. No assignment under this Section 12.2 shall relieve the assigning Party of any of its responsibilities or obligations hereunder and, as a condition of such assignment, the assignee shall agree in writing to be bound by all obligations of the assigning Party hereunder. This Agreement shall be binding upon the successors and permitted assigns of the Parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(d) Void Assignments**. Any assignment not in accordance with this Section 12.2 shall be void.

**12.3 Accounting Procedures**. Each Party shall calculate all amounts, and perform other accounting procedures required, under this Agreement and applicable to it in accordance with US GAAP or IFRS, as applicable. All terms of an accounting or financial nature in this Agreement shall be construed in accordance with the foregoing accounting standard.

**12.4 Force Majeure**. Neither Party shall be liable to the other Party or be deemed to have breached or defaulted under this Agreement for failure or delay in the performance of any of its obligations under this Agreement for the time and to the extent such failure or delay is caused by or results from acts of God, earthquake, riot, civil commotion, terrorism, war, strikes or other labor disputes, fire, flood, failure or delay of transportation, omissions or delays in acting by a governmental authority, acts of a government or an agency thereof or judicial orders or decrees or restrictions or any other reason which is beyond the control of the respective Party. The Party affected by force majeure shall provide the other Party with full particulars thereof as soon as it becomes aware of the same (including its best estimate of the likely extent and duration of the interference with its activities), and will use Commercially Reasonable Efforts to overcome the difficulties created thereby and to resume performance of its obligations hereunder as soon as practicable.

**12.5 No Trademark Rights**. No right, express of implied, is granted by this Agreement to a Party to use in any manner the name or any other trade name or trademark of the other Party in connection with the performance of this Agreement or otherwise. Each Party agrees not to use the name, trademark, logo, symbol or other image of the other Party or its Affiliates in any commercial activity, marketing, advertising, or sales brochures without the prior written consent of the other Party, which consent may be granted or withheld at the other Party's sole discretion.

**12.6 Entire Agreement of the Parties; Amendments**. This Agreement and the Schedules hereto constitute and contain the entire understanding and agreement of the Parties respecting the subject matter hereof and cancel and supersede any and all prior negotiations, correspondence, understandings and agreements between the Parties, whether oral or written, regarding such subject matter. Except as specified herein, no waiver, modification or amendment of any provision of this Agreement shall be valid or effective unless made in a writing referencing this Agreement and signed by a duly authorized officer of each Party.

**12.7 Captions**. The captions to this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement.

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Exhibit 10.20

**12.8 Governing Law**. This Agreement shall be governed by and interpreted in accordance with the laws of the Commonwealth of Massachusetts, excluding application of any conflict of laws principles that would require application of the Law of a jurisdiction outside of the Commonwealth of Massachusetts. In the event of any conflict between US and foreign laws, regulations and rules, US laws, regulations and rules shall govern. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement.

**12.9 Notices and Deliveries**. Any notice, request, approval or consent required or permitted to be given under this Agreement shall be in writing and shall be deemed to have been sufficiently given if delivered in person or by express courier service (signature required) to the Party to which it is directed at its address shown below or such other address as such Party shall have last given by notice to the other Purty.

If to Petra, addressed to:

Name: [\*\*\*]

Street: [\*\*\*]

City/State/Zip: [\*\*\*]

Country: [\*\*\*]

Attn: [\*\*\*]

If to Takeda, addressed to:

Name: Takeda Pharmaceutical Company Limited

Street: 40 Landsdowne Street

City/State/Zip: Cambridge, MA 02139

Country: U.S.A.

Attn: [\*\*\*]

**12.10 Language**. The official language of this Agreement and between the Parties for all correspondence shall be the English language.

**12.11 Waiver**. A waiver by either Party of any of the terms and conditions of this Agreement in any instance shall not be deemed or construed to be a waiver of such term or condition for the future, or of any other term or condition hereof. All rights, remedies, undertakings, obligations and agreements contained in this Agreement shall be cumulative and none of them shall be in limitation of any other remedy, right, undertaking, obligation or agreement of either Party.

**12.12 Severability**. When possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under Law, but if any provision of this Agreement is held to be prohibited by or invalid under Law, such provision will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of this Agreement. The Parties shall make a good faith effort to replace the invalid or unenforceable provision with a valid one which in its economic effect is most consistent with the invalid or unenforceable provision.

**12.13 No Implied License**. No right or license is granted to either Party hereunder by implication, estoppel, or otherwise to any know-how, patent or other intellectual property right owned or Controlled by the other Party or its Affiliates, except as expressly set forth in this Agreement.

------

Exhibit 10.20

**12.14 Interpretation**. The words "include," "includes" and "including" shall be deemed to be followed by the phrase "without limitation." All references herein to ARTICLES, Sections, and Schedules shall be deemed references to ARTICLES and Sections of, and Schedules to, this Agreement unless the context shall otherwise require. Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word "or" is used in the inclusive sense (and/or). Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. Each Party represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof. In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption will apply against the Party which drafted such terms and provisions. Unless the context otherwise requires, countries shall include territories. For clarity, any references in this Agreement to an amount paid by Petra as being "non-refundable" or "non-creditable" shall not be construed to limit Petra's right to seek to recover or actually recover any amount of damages arising from any uncured breach of this Agreement by Takeda, subject only to the limitations and exclusions in <u>Section 9.5</u>.

**12.15 Counterparts**. This Agreement may be executed in counterparts, each of which will be deemed an original, and all of which together will be deemed to be one and the same instrument. Transmission by fax or by electronic mail (in PDF form) or by any other electronic means intended to preserve the original appearance of the document, of an executed counterpart of this Agreement shall be deemed to constitute due and sufficient delivery of such counterpart and have the same effect as physical delivery of the paper document bearing the original signature.

**[SIGNATURE PAGE FOLLOWS]**

------

Exhibit 10.20

IN WITNESS WHEREOF, duly authorized representatives of the parties have executed this Agreement as of the date first above written.

---

| | |
|:---|:---|
| &nbsp;&nbsp;**TAKEDA PHARMACEUTICAL COMPANY LIMITED** | &nbsp;&nbsp;**PETRA PHARMA CORPORATION** |
| &nbsp;&nbsp;Signature:*<u>/s/ Fumihiko Sato</u>* | &nbsp;&nbsp;Signature:*<u>/s/ David Remus</u>* |
| &nbsp;&nbsp;Printed Name: <u>Fumihiko Sato</u> | &nbsp;&nbsp;Printed Name: <u>David Remus</u> |
| &nbsp;&nbsp;Title: <u>Head of Portfolio Strategic Relations</u> | &nbsp;&nbsp;Title: <u>CFO</u> |

---

------

Exhibit 10.20

**Exhibit A**

**<u>Excluded Indications</u>**

[\*\*\*]

------

Exhibit 10.20

**Exhibit B**

**<u>Takeda Know-How</u>**

<u>[</u>\*\*\*]

------

Exhibit 10.20

**Exhibit C**

**<u>Takeda Patents</u>**

[\*\*\*]

------

Exhibit 10.20

**Exhibit D**

**<u>Transfer of Licensed Compounds</u>**

[\*\*\*]

------

Exhibit 10.20

**Exhibit E**

**<u>Form of Convertible Promissory Note</u><br> (attached)**

[\*\*\*]

------

## Exhibit 10.21

Exhibit 10.21

*CERTAIN INFORMATION HAS BEEN EXCLUDED FROM THIS AGREEMENT (INDICATED BY "[\*\*\*]") BECAUSE SUCH INFORMATION IS BOTH (A) NOT MATERIAL AND (B) THE TYPE THAT THE REGISTRANT CUSTOMARILY AND ACTUALLY TREATS AS PRIVATE OR CONFIDENTIAL.*

**AMENDED AND RESTATED<br>TAK 228<br>ASSET PURCHASE AGREEMENT**

**between**

**Millennium Pharmaceuticals, Inc.**

**and**

**Calithera Biosciences, Inc.**

**Dated as of May 15, 2023**

------

Exhibit 10.21

---

| | |
|:---|:---|
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**ARTICLE 1 DEFINITIONS** | **1** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.1 Defined Terms** | **1** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.2 Additional Definitions** | **11** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.3 Construction of Certain Terms and Phrases** | **12** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**ARTICLE 2 PURCHASE AND SALE OF ASSETS** | **12** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.1 Closing** | **12** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.2 Closing Deliveries.** | **13** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.3 Purchase and Sale of Assets** | **13** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.4 Excluded Assets** | **13** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.5 License Back** | **13** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.6 Licensed Intellectual Property** | **14** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.7 Post-Closing Liabilities** | **14** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.8 Excluded Liabilities** | **15** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.9 Adverse Events** | **15** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.10 [INTENTIONALLY OMITTED].** | **16** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.11 Later-Discovered Assigned Intellectual Property, Assigned Agreements and Licensed Intellectual Property** | **16** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.12 Approval of Licensees** | **16** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**ARTICLE 3 DEVELOPMENT AND COMMERCIALIZATION OF PRODUCTS; ONGOING OBLIGATIONS** | **16** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.1 Responsibility** | **16** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.2 Diligence** | **16** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.3 Reports.** | **16** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.4 Audit** | **17** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.5 Assumption of Rights and Obligations under Assigned Agreements.** | **18** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.6 Related Agreements** | **18** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.7 Non-Assignable Contract** | **18** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.8 Cooperation in Combination Clinical Study(ies)** | **19** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.9 Delayed Assignment of Contracts for Clinical Studies** | **19** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**ARTICLE 4 CONTROL OF ASSIGNED PATENT RIGHTS** | **19** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.1 Control of Assigned Patent Rights.** | **19** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.2 Control of Licensed Intellectual Property** | **20** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.3 Ownership of Transaction IP** | **20** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**ARTICLE 5 PURCHASE PRICE AND OTHER PAYMENTS** | **20** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.1 Upfront Consideration Acknowledgement** | **20** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.2 Payment of Earn-out Payments; Earn-Out Rates.** | **20** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.3 Development Milestone Payments** | **22** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.4 Sales Milestone Payments** | **23** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.5 Payments in Dollars** | **24** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.6 Foreign Currency Exchange** | **24** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.7 Overdue Payments** | **24** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.8 Taxes.** | **24** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.9 Mode of Payment** | **26** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**ARTICLE 6 REPRESENTATIONS AND WARRANTIES** | **26** |

---

------

Exhibit 10.21

---

| | |
|:---|:---|
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.1 Representations and Warranties of Seller** | **26** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.2 Representations and Warranties of Buyer** | **28** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.3 Covenant of Buyer** | **30** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.4 No Other Warranties** | **30** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**ARTICLE 7 CONFIDENTIALITY** | **30** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.1 Confidentiality Obligations** | **30** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.2 Permitted Disclosures** | **31** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.3 Use of Name** | **32** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.4 Public Announcements.** | **32** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**ARTICLE 8 TERM** | **33** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**8.1 Term** | **33** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**8.2 Termination.** | **33** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**ARTICLE 9 SURVIVAL; INDEMNIFICATION; INSURANCE; LIMITATIONS** | **35** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.1 Survival of Representations, Warranties and Covenants.** | **35** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.2 Indemnification by Buyer** | **35** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.3 Indemnification by Seller** | **36** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.4 Limitations.** | **36** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.5 Procedures.** | **37** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.6 Sole Remedy** | **38** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.7 Insurance** | **38** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.8 LIMITATION OF DAMAGES** | **39** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**ARTICLE 10 MISCELLANEOUS** | **39** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.1 Entire Agreement; Amendment** | **39** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.2 Governing Law; Jurisdiction** | **39** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.3 Waiver of Jury Trial** | **40** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.4 Notice** | **40** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.5 Compliance with Law; Severability** | **40** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.6 Successors and Assigns** | **41** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.7 Waivers** | **41** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.8 Force Majeure** | **41** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.9 No Third Party Beneficiaries** | **41** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.10 Headings; Schedules and Exhibits** | **41** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.11 Counterparts** | **41** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.12 Specific Performance** | **42** |

---

**<u>SCHEDULES</u>**

Schedule 1.1(a) TAK-228 Structure

Schedule 1.1(b) [\*\*\*] Structure

Schedule 1.1(c) Materials

Schedule 1.1(d) Regulatory Materials

Schedule 1.1(e) Existing Inventory Transferred/Assigned

Schedule 1.1(f) Assigned Agreements

Schedule 1.1(g) Assigned Know-How

------

Exhibit 10.21

Schedule 1.1(h) – Part 1 Assigned Patent Rights

Schedule 1.1(h) – Part 2 In-Licensed Patent Rights

Schedule 1.1(i) Development Plan

Schedule 2.3 Acquired Assets

Schedule 2.4 Select list of Excluded Assets

Schedule 2.6 Licensed Intellectual Property

Schedule 3.6 Related Agreements

Schedule 3.9 Delayed Assigned Contracts

Schedule 5.9 Seller's Bank Account

**<u>EXHIBITS</u>**

Exhibit A Bill of Sale

Exhibit B Patent Assignment Agreement

Exhibit C Press Release

Exhibit D Disclosure Schedules

Exhibit E Memorandum of Understanding

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Exhibit 10.21

**<u>AMENDED AND RESTATED ASSET PURCHASE AGREEMENT</u>**

This Amended and Restated Asset Purchase Agreement (this "**Agreement**") is made and entered into as of May 15, 2023 (the "**Effective Date**") between Millennium Pharmaceuticals, Inc., a Delaware corporation ("**Seller**"), and Calithera Biosciences, Inc., a Delaware corporation ("**Buyer**"). Buyer and Seller are sometimes referred to herein individually as a "**Party**" and collectively as the "**Parties**".

**RECITALS**

**WHEREAS**, Seller and Buyer are parties to that certain Asset Purchase Agreement, dated October 18, 2021 (the "**Original Effective Date**"), amended May 23, 2022, May 31, 2022 (twice on such date under separate amending documents), and November 28, 2022 (as amended, the "**Original Agreement**"), under which Seller sold and/or licensed to Buyer, and Buyer purchased and/or licensed from Seller, (a) certain assets of Seller used in or relating to Seller's small molecule program internally coded by Seller as TAK-659, and (b) certain assets of Seller used in or relating to Seller's small molecule programs internally coded by Seller as TAK-228;

**WHEREAS**, Buyer wishes to be able to assign and transfer its rights and obligations under the Original Agreement with respect to the TAK-659 program separately from its rights and obligations under the Original Agreement with respect to the TAK-228 program; and

**WHEREAS**, the Parties desire to replace the Original Agreement with two separate agreements by (a) entering into an amended and restated agreement containing the terms of the Original Agreement that pertain only to TAK-659 Products, and (b) entering into this Agreement, which amends and restates the Original Agreement in its entirety to remove all provisions relating to TAK-659 Products so that it pertains only to TAK-228 Products.

**AGREEMENT**

**NOW, THEREFORE**, in consideration of the premises and the mutual covenants, representations and warranties herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby mutually acknowledged, the Parties hereby agree as follows:

**ARTICLE 1**<br>**DEFINITIONS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.1 Defined Terms.** As used in this Agreement, the following defined terms shall have the meanings specified below:

"**Additional Active**" means one (1) or more active pharmaceutical or biological ingredients for which no earn-out payments would be due hereunder if such ingredient(s) were sold separately from a Product.

"**Affiliate**" means, with respect to any Person, any other Person that controls, is controlled by or is under common control with such Person, for as long as such control exists. For purposes of this definition, "control" means the direct or indirect ownership of more than fifty percent (50%) of the voting or economic interest of a Person, or the power, whether pursuant to contract, ownership of securities or otherwise, to direct the management and policies of a Person. For clarity, once a Person ceases to be an

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Exhibit 10.21

Affiliate of a Party, then, without any further action, such Person shall no longer be considered an Affiliate of such Party for purposes of this Agreement.

"**Ancillary Agreements**" means, collectively, the Bill of Sale, the Patent Assignment Agreement, the Equity Agreement and such other agreements as may be executed in connection with the transactions contemplated by this Agreement.

"**Annual Net Sales**" means, with respect to a Product, the cumulative worldwide Net Sales of such Product in any Calendar Year.

"**Assigned Agreements**" means, subject to <u>Section 3.9</u>, the agreements set forth on <u>Schedule 1.1(f)</u>.

"**Assigned Intellectual Property**" means the Assigned Patent Rights and the Assigned Know-How, including Seller's interest in Transaction IP that is solely related to the Program.

"**Assigned Know-How**" means Know-How that is: (a) owned by Seller or any of its Affiliates (i) as of the Closing Date or (ii) on or after the Closing Date and (A) included in the Transaction IP or (B) owned pursuant to a Non-Assignable Contract or Related Agreement, in each case (A) and (B) pursuant to <u>Section 4.3</u>, (b) necessary to research and develop, make, have made, use, sell, offer for sale, and import any Product in the Field in the Territory, and (c) solely related to the Program, as applicable. The Assigned Know-How as of the Closing Date is set forth on <u>Schedule 1.1(g)</u>. For clarity, Know-How relating to a Program Molecule in combination with a Takeda Compound is explicitly excluded from Assigned Know-How.

"**Assigned Patent Rights**" means (x) Patent Rights that are: (a) owned by Seller or any of its Affiliates (i) as of the Closing Date or (ii) on or after the Closing Date and (A) included in the Transaction IP or (B) owned pursuant to a Non-Assignable Contract or Related Agreement, in each case (A) and (B) pursuant to <u>Section 4.3</u>, (b) necessary to research and develop, make, have made, use, sell, offer for sale, and import any Product in the Field in the Territory, and (c) solely related to the Program, as applicable, and (y) Patent Rights that claim priority to the Patent Rights in the preceding clause (x). The Assigned Patent Rights as of the Closing Date are set forth on <u>Schedule 1.1(h) – Part 1</u>. For clarity, Assigned Patent Rights do not include any Patent Rights relating to a Program Molecule in combination with a Takeda Compound.

"**Bill of Sale**" means the bill of sale that was executed and delivered at Closing, attached hereto as <u>Exhibit A</u>, selling, assigning, transferring, conveying and delivering certain assets, including the Acquired Assets.

"**Business Day**" means any day that is not: (a) a Saturday or a Sunday or (b) any day that is a legal holiday under the applicable Laws of the United States or Japan or that is a day on which banking institutions in New York City, New York, or Tokyo, Japan, are authorized or required by applicable Laws or other governmental action to close.

"**Calendar Quarter**" means the period beginning on the Closing Date and ending on the last day of the calendar quarter in which the Closing Date falls, and thereafter each successive period of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31; *provided*, *that*, the final Calendar Quarter shall end on the last day of the Term.

"**Calendar Year**" means the period beginning on the Closing Date and ending on December 31 of the calendar year in which the Closing Date falls, and thereafter each successive period of

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Exhibit 10.21

twelve (12) months commencing on January 1 and ending on December 31; *provided*, *that*, the final Calendar Year shall end on the last day of the Term.

"**CDA**" means the Confidential Disclosure Agreement dated as of March 26, 2021 (the "**CDA Effective Date**") by and between Buyer and Takeda Pharmaceuticals U.S.A., Inc.

"**Change of Control**" means any of the following: (a) the acquisition by a Third Party, directly or indirectly, of the beneficial ownership of any voting security of a Party, or increase in the percentage ownership of a Third Party in the voting securities of a Party through stock redemption, cancellation or other recapitalization, where immediately after such acquisition or increase such Third Party is, directly or indirectly, the beneficial owner of voting securities representing more than fifty percent (50%) of the total voting power of all of the then-outstanding voting securities of such Party; (b) the consummation of a merger, consolidation, recapitalization, reorganization, amalgamation, arrangement, share exchange, tender or exchange offer, private purchase, business combination or other transaction of a Party, other than any such transaction which would result in an Affiliate of a Party, immediately prior to such transaction, owning fifty percent (50%) or more of the outstanding securities of the surviving entity (or its parent entity) immediately following such transaction; or (c) the sale or disposition by such Party of all or a substantial portion of such Party's assets or all or substantially all of such Party's assets which relate to this Agreement to a Third Party, other than to an Affiliate of such Party.

"**Code**" means the Internal Revenue Code of 1986, as amended.

"**Combination Product**" means any (a) product that includes a Program Molecule and one (1) or more Additional Actives or (b) Product sold with one (1) or more other product(s) containing or comprising one (1) or more Additional Actives for a single invoice price.

"**Commercially Reasonable Efforts**" means with respect to development or commercialization activities that Buyer performs pursuant to this Agreement, [\*\*\*].

"**Contracts**" means any and all binding commitments, contracts, purchase orders, licenses, or other agreements, whether written or oral.

"**Control**" means, with respect to any Know-How or Patent Rights, the possession by a Party of the right to transfer or grant a license, sublicense or other rights to such Know-How or Patent Rights (before giving effect to the rights granted by one Party to the other Party pursuant to this Agreement), without violating the terms of any agreement or arrangement with any Third Party.

"**Court**" means any court or arbitration tribunal of the United States, any domestic state, or any foreign country, and any political subdivision thereof.

"**Development Plan**" means the plan setting forth the development activities to be undertaken by Buyer. The Development Plan as of the Effective Date is attached hereto as <u>Schedule 1.1(i)</u>.

"**Distributor**" means any Third Party which purchases its requirements for a Product in a country from Buyer or its Affiliates or Licensees and is appointed as a distributor to distribute, market and resell such Product in such country, even if such Third Party is granted ancillary rights to develop, package or obtain Regulatory Approvals of such Product in order to distribute, market or sell such Product in such country.

"**Dollar**" means United States dollar, and "$" shall be interpreted accordingly.

------

Exhibit 10.21

"**EMA**" means the European Medicines Agency or any successor agency or authority thereto.

"**Encumbrance**" means any encumbrance, claim, mortgage, pledge, assessment, security interest, option, license, right of first refusal or preemptive right, hypothecation, equitable interest, preference, right of possession, deed of trust, lease, lien, levy, restriction on transferability, defect in title, charge or other encumbrance of any kind, whether voluntarily incurred or arising by operation of applicable Law, any obligation to pay Taxes, any conditional sale or title retention agreement or other agreement granting any of the foregoing in the future or otherwise.

"**Equity Agreement**" means the Preferred Stock Purchase Agreement entered into on the Original Effective Date.

"**EU 5 Countries**" means United Kingdom, Germany, France, Spain and Italy.

"**Existing Inventory**" means certain existing inventory for the Program as set forth on <u>Schedule 1.1(e)</u>.

"**FDA**" means the United States Food and Drug Administration or any successor agency or authority thereto.

"**FDCA**" means the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time, including additions, supplements, extensions, and modifications thereto.

"**Field**" means any therapeutic, prophylactic, preventative or diagnostic use in or for animals, including humans.

"**First Commercial Sale**" means, with respect to any Product in any country in the Territory, the first invoiced commercial sale, transfer or disposition for monetary value for use or consumption of that Product in that country after Regulatory Approval for that Product has been received in that country; *provided*, *that*, the following shall not constitute a First Commercial Sale: (a) any sale to an Affiliate or licensee (unless the Affiliate or licensee is the last entity in the distribution chain of the Product) or (b) any transfers of a Product without consideration or for nominal consideration for use in any clinical trial, or for any bona fide charitable, compassionate use or indigent patient program purpose where Products are sold at or below cost of goods sold, or as a sample.

"**Force Majeure**" means any occurrence beyond the reasonable control of a Party, including any act of God, flood, fire, explosion, earthquake, strike, lockout, quarantine, epidemic, labor dispute, casualty or accident, or war, revolution, civil commotion, act of terrorism, blockage or embargo, or any injunction, law, order, proclamation, regulation, ordinance, demand or requirement of any Governmental Entity or of any subdivision, authority or representative of any such Governmental Entity.

"**FTE**" means the equivalent of a full-time individual's work time actually spent on the performance of activities under this Agreement over a twelve (12) month period (including normal vacations, sick days and holidays) based on one thousand eight hundred (1800) hours worked per twelve (12)-month period. In no event shall one person be counted as more than one FTE.

"**FTE Rate**" means a rate of [\*\*\*] per FTE per year.

"**Fundamental Representations**" means the representations and warranties set forth in [\*\*\*].

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Exhibit 10.21

"**Generic Product**" means, with respect to a particular Product and regulatory jurisdiction, any pharmaceutical product that is sold by a Third Party (other than a Licensee) in such regulatory jurisdiction and that (a) contains the same Program Molecule as such Product; and (b) has obtained marketing authorization for use pursuant to a Regulatory Approval process governing approval of generic or interchangeable drugs based on the then-current standards in such regulatory jurisdiction; and (c) has been deemed by the applicable Regulatory Authority as substitutable for such Product in such country.

"**Governmental Entity**" means any court, tribunal, arbitrator, Regulatory Authority, agency, commission, department, ministry, official or other instrumentality of the United States or other country, or any supra-national organization, or any foreign or domestic, state, county, city or other political subdivision.

"**IND**" means (a) an Investigational New Drug Application (as defined in the FDCA and the regulations promulgated thereunder) or any successor application or procedure required to initiate clinical testing of a therapeutic product in humans in the United States; (b) the equivalent of an Investigational New Drug Application that is required in any other country or region before beginning clinical testing of a therapeutic product in humans in such country or region (including any Clinical Trial Authorization required to initiate clinical testing of a therapeutic product in humans in the United Kingdom); and (c) all supplements and amendments to any of the foregoing.

"**Indemnified Party**" means a Seller Indemnified Party or Buyer Indemnified Party, as the case may be.

"**In-Licensed Patent Rights**" means the Patent Rights licensed under an Assigned Agreement.

"**Know-How**" means, collectively, any knowledge, information, techniques, technology, trade secrets, inventions (whether patentable or not), discoveries, methods, know-how, data and results, including all technical, scientific, pre-clinical, clinical and regulatory data (including pharmacological, biological and toxicological data and results), analytical and quality control data and results and other information, but excludes Patent Rights with respect to any of the foregoing.

"**Knowledge**" means, with respect to Seller, the actual knowledge of a fact or other matter [\*\*\*] for the Program.

"**Law**" means any federal, state, local or foreign law, statute, code or ordinance, treaties (including tax treaties) or any rule or regulation promulgated by any Governmental Entity including all decisions of any Courts having the effect of law in each such jurisdiction.

"**Liability**" means any and all debts, liabilities and obligations, whether known or unknown, asserted or unasserted, determinable or otherwise, accrued or fixed, absolute or contingent, liquidated or unliquidated, incurred or consequential, or matured or unmatured, including those arising under any Law, Litigation, Order, or Contract.

"**Licensee**" means any Third Party to which Buyer grants a license under the Assigned Intellectual Property, a sublicense under Patent Rights or Know-How licensed to Buyer under any of the Assigned Agreements, or a sublicense under any Patent Rights within the Licensed Intellectual Property, for the development, manufacture, use or commercialization of any Product, beyond the mere right to purchase any Product from or to provide services on behalf of Buyer or its Affiliates, but expressly excluding contract manufacturers and contract research or development organizations.

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Exhibit 10.21

"**Litigation**" means any suit, action, arbitration, cause of action, claim, complaint, criminal prosecution, investigation, inquiry, demand letter, judicial, arbitration or other administrative proceeding, whether at law or at equity, before or by any Court, Governmental Entity, arbitrator or other tribunal.

"**Materials**" means the materials set forth on <u>Schedule 1.1(c)</u>.

"**NDA**" means a New Drug Application, as defined in the FDCA, or any successor application or procedure required to sell any Product in the United States.

"**Net Sales**" means, with respect to a Product, the gross amount invoiced in a country by Buyer or its Affiliates or Licensees (each of the foregoing Persons, a "**Selling Party**") for the sale or other disposition of such Product in such country to Third Parties (including contract sales forces and Distributors), less the following deductions calculated in accordance with US GAAP, consistently applied by the relevant Selling Party, to the extent allocated to such Product and actually taken, paid, allowed, or allocated in the gross sales price with respect to such sales, and not otherwise recovered by or reimbursed to the Selling Party, as set forth below:

[\*\*\*]

Notwithstanding the foregoing, and subject to the remainder of this paragraph, amounts received or invoiced by a Selling Party for the sale of such Product to another Selling Party for resale will not be included in the computation of Net Sales hereunder so long as, if such Product is subsequently resold to a non-Selling Party, such subsequent sale is included in the computation of Net Sales. For purposes of determining Net Sales, a Product will be deemed to be sold when recorded as a sale by the Selling Party, in accordance with US GAAP. For clarity, a particular deduction may only be accounted for once in the calculation of Net Sales.

[\*\*\*]

In the case of any Combination Product sold in a given country in the Territory during a given Calendar Quarter, Net Sales of the Combination Product in such country during such Calendar Quarter will be calculated by [\*\*\*].

[\*\*\*]

"**Order**" means any judgment, order, writ, injunction, ruling, stipulation, determination, award or decree of or by, or any settlement under the jurisdiction of, any Court or Governmental Entity.

"**Original Agreement**" has the meaning set forth in the recitals.

"**Original Effective Date**" has the meaning set forth in the recitals.

"**Patent Assignment Agreement**" means the patent assignment agreement, substantially in the form attached as <u>Exhibit B</u>.

"**Patent Rights**" means the rights and interests in and to issued patents and pending patent applications (which, for purposes of this Agreement, include certificates of invention, applications for certificates of invention and priority rights) in any country or region, including any divisionals, continuations, continuations-in-part, substitutions, patents of addition, reissues, extensions, re-examinations or renewal applications related to, or claiming priority to, the foregoing (including any

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Exhibit 10.21

supplementary protection certificates) or any confirmation patent or registration patent, and all patents issuing on, and all foreign counterparts of, any of the foregoing.

"**Permitted Encumbrances**" means (a) statutory liens with respect to the payment of Taxes, in all cases which are not yet due or payable or that are being contested in good faith; (b) statutory liens of landlords, suppliers, mechanics, carriers, materialmen, warehousemen, service providers or workmen and other similar liens imposed by applicable Law created in the ordinary course of business the existence of which do not constitute a default or breach under any of the Assigned Agreements; (c) licenses under the Assigned Intellectual Property and In-Licensed Patent Rights granted as of the Closing Date under the Assigned Agreements, Delayed Assigned Contracts, Related Agreements, and Non-Assignable Contracts; and (d) licenses under later-discovered Assigned Intellectual Property subject to <u>Section 2.11</u> under the Assigned Agreements, Related Agreements, and Non-Assignable Contracts; excluding any of the above liens (i) to the extent they relate to any activity prior to the Closing Date, or (ii) constituting Sellers Taxes.

"**Person**" means any natural person, corporation, general partnership, limited partnership, limited liability company, proprietorship, joint venture, other business organization, trust, entity, union, association or Governmental Entity.

"**Post-Closing Tax Period**" means any taxable period beginning after the Closing Date, and the portion of any Straddle Period beginning the day after the Closing Date.

"**Pre-Closing Tax Period**" means any taxable period (or portion of a Straddle Period) ending on or before the Closing Date.

"**Product**" means any product that contains or comprises a Program Molecule, alone or in combination with one or more Additional Active(s), in any formulation or dosage form and for any mode of administration [\*\*\*].

"**Program**" means the Seller's program, as of the Closing Date, that is focused on developing Program Molecules.

"**Program Molecule**" means (a) the small molecule internally coded by Seller as TAK-228 (also referred to as sapanisertib), which has the structure set forth on <u>Schedule 1.1(a)</u>, (b) any compound that falls within the scope of the claims, or is otherwise disclosed, in an Assigned Patent Right that also claims or discloses the molecule described in the foregoing clause (a), or (c) any salt, free acid or base, complex, solvate, hydrate, isotope, polymorph, stereoisomer, tautomer, ester, polymorph, stereoisomer, metabolite or prodrug of (a) or (b).

"**Registrational Trial**" means a single randomized, placebo or active controlled human clinical trial of a Product on sufficient numbers of patients that is designed to demonstrate statistically that such Product is safe and efficacious for its[ intended use, to evaluate the risk-benefit relationship of such Product, and to define warnings, precautions and adverse reactions that are associated with such Product in the dosage range to be prescribed, as described in 21 C.F.R. §312.21(c) or corresponding foreign regulations, and that is intended to support obtaining Regulatory Approval of such Product, regardless of whether such trial is referred to as a "**Phase 2 Trial**", "**Phase 2b Trial**", "**Phase 2[b]/3**" or Phase 3 Trial. If a clinical trial of a Product is not initially designed as a Registrational Trial but is later re-designed, converted or expanded into such a trial (an "**Adjusted Registrational Trial**"), then it shall be deemed to be a Registrational Trial hereunder as of the date of such re-design, conversion or expansion. [\*\*\*].

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Exhibit 10.21

"**Regulatory Approval**" means the approval, license or authorization of the applicable Regulatory Authority necessary for the marketing and sale of a Product for a particular indication, and including the approval by the applicable Regulatory Authority of any expansion or modification of the label for such indication.

"**Regulatory Authority**" means any national, supra-national (e.g. the European Commission or the Council of the European Union), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity with authority over the distribution, importation, exportation, manufacture, production, use, storage, transport, clinical testing, marketing, pricing or sale of a Product in such country or region in the Territory, including the FDA, the EMA, the Japanese Ministry of Health, Labour and Welfare and any successor entity thereto, the Pharmaceuticals and Medical Devices Agency of Japan and any successor entity thereto and the UK Medicines and Healthcare products Regulatory Agency in the United Kingdom and any successor entity thereto.

"**Regulatory Exclusivity**" means any exclusive marketing rights or data exclusivity rights conferred by any Governmental Entity with respect to a Product, other than Patent Rights, including rights conferred in the United States to a NDA holder under the Hatch-Waxman Act or the FDA Modernization Act of 1997 (including pediatric exclusivity), or rights similar thereto outside the United States.

"**Regulatory Filing**" means, collectively: (a) any IND, Marketing Authorization Application (MAA), drug master file, application for designation as an "**Orphan Drug**" under the Orphan Drug Act, for "**Fast Track**" status under Section 506 of the FDCA (21 U.S.C. § 356) or for a Special Protocol Assessment under Section 505(b)(4)(B) and (C) of the FDCA (21 U.S.C. § 355(b)(4)(B)) and all other similar filings (including counterparts of any of the foregoing in any country or region in the Territory); (b) all supplements and amendments to any of the foregoing; and (c) all data and other information contained in, and correspondence relating to, any of the foregoing.

"**Regulatory Materials**" means the materials set forth on <u>Schedule 1.1(d)</u>. For clarity, Regulatory Materials relating to a Program Molecule in combination with a Takeda Compound are explicitly excluded.

"**Seller Taxes**" means (a) all Taxes of Seller or its Affiliates, or for which the Seller or any of its Affiliates is or are liable (including as a transferee or successor, or by contract or otherwise by operation of Law), for any taxable period (including any Tax of the Seller or any of its Affiliates that becomes a Liability of Buyer under any common law doctrine of de facto merger or transferee or successor liability or otherwise by operation of contract or Law), and (b) all Taxes relating to the ownership of the Acquired Assets for any Pre-Closing Tax Period, including the portion of any Straddle Period ending on the relevant Assignment Date as determined by <u>Section 5.8.7</u>.

"**Straddle Period**" means any taxable period that begins on or before but does not end on the relevant Assignment Date.

"**TAK-228**" means (a) the small molecule internally coded by Seller as TAK-228 (also referred to as sapanisertib [\*\*\*]), which has the structure set forth on <u>Schedule 1.1(a)</u>, (b) any compound that falls within the scope of the claims, or is otherwise disclosed, in an Assigned Patent Right that also claims or discloses the molecule described in the foregoing clause (a), or (c) any salt, free acid or base, complex, solvate, hydrate, isotope, polymorph, stereoisomer, tautomer, ester, polymorph, stereoisomer, metabolite or prodrug of (a) or (b).

"**TAK-659**" means [\*\*\*].

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Exhibit 10.21

"**TAK-228 Product**" means any product that contains or comprises TAK-228, alone or in combination with one or more Additional Active(s), in any formulation or dosage form and for any mode of administration; *provided that*, in no event will any TAK-228 Product include any Takeda Compounds or TAK-659.

"**TAK-659 Product**" means any product that contains or comprises TAK-659, alone or in combination with one or more Additional Active(s), in any formulation or dosage form and for any mode of administration; *provided that*, in no event will any TAK-659 Product include any Takeda Compounds or TAK-228.

"**Takeda Compound**" means any compound or molecule owned or Controlled by Seller or its Affiliates (including TAK-659 and any such compound or molecule that has been exclusively licensed by Seller or its Affiliates) but excluding any Program Molecule.

"**Tax**" or "**Taxes**" means any federal, state, local or foreign income, gross receipts, branch profits, license, payroll, employment, excise, severance, stamp, occupation, premium, windfall profits, escheat, environmental, customs duties, capital stock, franchise, profits, withholding, social security, unemployment, disability, real property, personal property, sales, use, transfer, registration, ad valorem, value added, alternative or add-on minimum or estimated tax or other tax of any kind whatsoever, including any interest, penalty or addition thereto, whether disputed or not and including any obligation to indemnify or otherwise assume or succeed to the tax liability of any other Person by Law, by Contract or otherwise.

"**Tax Return**" means any return, declaration, notice, statement, claim for refund, report or form (including any schedule or attachment thereto) or other document filed or required to be filed with respect to Taxes and including all amendments or supplements thereof.

"**Territory**" means worldwide.

"**Third Party**" means a Person other than Buyer, Seller or their respective Affiliates.

"**US GAAP**" means United States Generally Accepted Accounting Principles.

"**Valid Claim**" means (a) any claim of an issued and unexpired patent within the Assigned Patent Rights, [\*\*\*] or In-Licensed Patent Rights that has not been held unpatentable, invalid or unenforceable by a decision of a Court or other Governmental Entity of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been cancelled, withdrawn, revoked, abandoned or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, or (b) a claim of a pending patent application included within the Assigned Patent Rights, [\*\*\*] or In-Licensed Patent Rights that is being prosecuted in good faith and has not lapsed, been abandoned, been cancelled or revoked, or been deemed unenforceable or invalid by a non-appealable decision or an appealable decision from which no appeal was taken within the time allowed for such appeal of a Court or other Governmental Entity of competent jurisdiction, which claim has not been pending for more than [\*\*\*] from [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.2 Additional Definitions.** In addition, each of the following definitions shall have the respective meanings set forth in the section of this Agreement indicated below:

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| | |
|:---|:---|
| &nbsp;&nbsp;<u>Definition</u> | &nbsp;&nbsp;<u>Section</u> |
| &nbsp;&nbsp;Acquired Assets | &nbsp;&nbsp;2.3 |
| &nbsp;&nbsp;Adjusted Registrational Trial | &nbsp;&nbsp;"Registrational Trial" definition |
| &nbsp;&nbsp;Agreed Claims | &nbsp;&nbsp;9.5.5 |

---

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Exhibit 10.21

---

| | |
|:---|:---|
| &nbsp;&nbsp;Agreement | &nbsp;&nbsp;Preamble |
| &nbsp;&nbsp;Allocation Schedule | &nbsp;&nbsp;5.8.6 |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;3.3.2 |
| &nbsp;&nbsp;Assignment Consent | &nbsp;&nbsp;3.7 |
| &nbsp;&nbsp;Assignment Date | &nbsp;&nbsp;3.9 |
| &nbsp;&nbsp;Bankruptcy Laws | &nbsp;&nbsp;8.2.2(b) |
| &nbsp;&nbsp;Breaching Party | &nbsp;&nbsp;8.2.1 |
| &nbsp;&nbsp;Buyer | &nbsp;&nbsp;Preamble |
| &nbsp;&nbsp;Buyer Indemnified Parties | &nbsp;&nbsp;9.3 |
| &nbsp;&nbsp;CDA Effective Date | &nbsp;&nbsp;"CDA" definition |
| &nbsp;&nbsp;Claim Certificate | &nbsp;&nbsp;9.5.1 |
| &nbsp;&nbsp;Claims | &nbsp;&nbsp;9.2 |
| &nbsp;&nbsp;Closing | &nbsp;&nbsp;2.1 |
| &nbsp;&nbsp;Closing Date | &nbsp;&nbsp;2.1 |
| &nbsp;&nbsp;Code | &nbsp;&nbsp;5.8.6 |
| &nbsp;&nbsp;Confidential Information | &nbsp;&nbsp;7.1 |
| &nbsp;&nbsp;Cure Period | &nbsp;&nbsp;8.2.1 |
| &nbsp;&nbsp;Deductible | &nbsp;&nbsp;9.4.1 |
| &nbsp;&nbsp;Delayed Assigned Contract | &nbsp;&nbsp;3.9 |
| &nbsp;&nbsp;Development Milestone Event | &nbsp;&nbsp;5.3 |
| &nbsp;&nbsp;Development Milestone Payment | &nbsp;&nbsp;5.3 |
| &nbsp;&nbsp;Excluded Assets | &nbsp;&nbsp;2.4 |
| &nbsp;&nbsp;Excluded Liabilities | &nbsp;&nbsp;2.8 |
| &nbsp;&nbsp;Indemnifying Party | &nbsp;&nbsp;9.5.1 |
| &nbsp;&nbsp;Indication | &nbsp;&nbsp;5.3 |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;5.2.4 |
| &nbsp;&nbsp;Licensed Intellectual Property | &nbsp;&nbsp;2.6 |
| &nbsp;&nbsp;Losses | &nbsp;&nbsp;9.2 |
| &nbsp;&nbsp;Non-Breaching Party | &nbsp;&nbsp;8.2.1 |
| &nbsp;&nbsp;Non-Assignable Contract | &nbsp;&nbsp;3.7 |
| &nbsp;&nbsp;Party/Parties | &nbsp;&nbsp;Preamble |
| &nbsp;&nbsp;Post-Closing Liabilities | &nbsp;&nbsp;2.7 |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;4.1.3 |
| &nbsp;&nbsp;Related Agreements | &nbsp;&nbsp;3.6 |
| &nbsp;&nbsp;Report | &nbsp;&nbsp;3.3.1 |
| &nbsp;&nbsp;Sales Milestone Event | &nbsp;&nbsp;5.4 |
| &nbsp;&nbsp;Sales Milestone Payment | &nbsp;&nbsp;5.4 |
| &nbsp;&nbsp;Section 2.5(b) IP | &nbsp;&nbsp;2.5 |
| &nbsp;&nbsp;Seller | &nbsp;&nbsp;Preamble |
| &nbsp;&nbsp;Seller Indemnified Parties | &nbsp;&nbsp;9.2 |
| &nbsp;&nbsp;Selling Party | &nbsp;&nbsp;"Net Sales" definition |
| &nbsp;&nbsp;Term | &nbsp;&nbsp;8.1 |
| &nbsp;&nbsp;Third-Party Claim | &nbsp;&nbsp;9.5.1 |
| &nbsp;&nbsp;Transaction IP | &nbsp;&nbsp;4.3 |
| &nbsp;&nbsp;Transfer Taxes | &nbsp;&nbsp;5.8.4 |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.3 Construction of Certain Terms and Phrases.** Unless the context of this Agreement otherwise requires: (a) words of any gender include each other gender; (b) words using the singular or plural number also include the plural or singular number, respectively; (c) the terms "hereof," "herein," "hereby" and derivative or similar words refer to this entire Agreement; (d) the terms "Article" or "Section" refer to the specified Article or Section of this Agreement; (e) the term "or" has, except where otherwise indicated,

------

Exhibit 10.21

the inclusive meaning represented by the phrase "and/or"; (f) the term "including" means "including without limitation"; and (g) whenever this Agreement refers to a number of days, such number shall refer to calendar days unless Business Days are specified.

**ARTICLE 2**<br>**PURCHASE AND SALE OF ASSETS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.1 Closing.** The Parties acknowledge that the consummation (the "**Closing**") of the transactions contemplated by the Original Agreement and the Ancillary Agreements took place remotely via the exchange of documents and signatures on the Original Effective Date. The date on which the Closing occurred is referred to herein as the "**Closing Date**".

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.2 Closing Deliveries.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.2.1** The Parties acknowledge that, on or prior to the Closing Date, Seller delivered to Buyer the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)** the Bill of Sale, duly executed by Seller;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** the Equity Agreement, duly executed by Seller;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c)** the Patent Assignment Agreement, duly executed by Seller; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(d)** such other documents and instruments of transfer as Buyer and Seller mutually agreed were necessary to evidence or effectuate the transactions contemplated by the Original Agreement and the Ancillary Agreements.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.2.2** The Parties acknowledge that, on or prior to the Closing Date, Buyer delivered to Seller the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)** the Bill of Sale, duly executed by Buyer;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** the Patent Assignment Agreement, duly executed by Buyer;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c)** the Equity Agreement, duly executed by Buyer; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(d)** such other documents and instruments of transfer as Buyer and Seller mutually agreed were necessary to evidence or effectuate the transactions contemplated by the Original Agreement and the Ancillary Agreements.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.3 Purchase and Sale of Assets.** Subject to the terms and conditions set forth in the Original Agreement and this Agreement, effective on the Closing Date, Seller hereby sells, conveys, assigns, transfers and delivers to, and shall cause its Affiliates to sell, convey, assign, transfer and deliver to, Buyer, and Buyer hereby purchases and acquires from each of Seller or its Affiliates, as the case may be, all of Seller's and its Affiliates' right, title and interest in and to the assets described or set forth on <u>Schedule 2.3</u> attached hereto (collectively, the "**Acquired Assets**"), free and clear of all Encumbrances (other than Permitted Encumbrances).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.4 Excluded Assets.** No right, title or interest is being sold, assigned, transferred, conveyed or delivered to Buyer in or to (a) any of the property and assets of Seller other than the Acquired Assets, or

------

Exhibit 10.21

(b) any rights or claims of Seller under this Agreement (collectively, the "**Excluded Assets**"). For the avoidance of doubt, Excluded Assets include the assets set forth in <u>Schedule 2.4</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.5 License Back.** Buyer hereby grants Seller and its Affiliates (a) a non-exclusive, non-transferable, royalty-free, fully paid-up license under the Assigned Intellectual Property, with the right to sublicense solely to those counterparties to the Related Agreements and Non-Assignable Contracts to whom Seller had granted a license under the Assigned Intellectual Property prior to the Closing Date, solely as necessary for Seller or its Affiliate to perform Seller's obligations under this Agreement and any Ancillary Agreement (including the continued performance of any Related Agreement or Non-Assignable Contract), and (b) a non-exclusive, irrevocable royalty-free, fully paid-up license, with the right to sublicense to service providers and the like conducting activities on behalf of Seller or its Affiliate, under the Assigned Intellectual Property for non-clinical, internal research purposes. Each sublicense shall be consistent with the terms and conditions of this Agreement, including requiring each such sublicensee to assign or license Transaction IP to Seller and to protect and keep confidential any Confidential Information of the Parties in accordance with <u>Article 7</u> of this Agreement. For clarity, the license in the foregoing clause (a) includes the right to manufacture until [\*\*\*], Product that is necessary to perform Seller's supply obligations existing as of the Closing Date under Related Agreements and Non-Assignable Contracts. If Seller requires a sublicense under any intellectual property licensed under an Assigned Agreement to perform its obligations under this Agreement or any Ancillary Agreement, the Parties will enter into a separate sublicense agreement. Any Know-How or Patent Rights that arise from the practice of the license granted pursuant to clause (b) above shall be referred to as "**Section 2.5(b) IP**".

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.6 Licensed Intellectual Property.** To the extent Seller or its Affiliate Controls any Patent Rights or Know-How (a) as of the Closing Date; or (b) on or after the Closing Date and (A) included in the Transaction IP, (B) Controlled pursuant to a Non-Assignable Contract or Related Agreement, in each case (A) and (B) pursuant to <u>Section 4.3</u>, or (C) constituting <u>Section 2.5(b)</u> IP, that in each case (a) and (b) are necessary to research and develop, make, have made, use, sell, offer for sale, and import Products (including researching, developing, and making Program Molecules for the purpose of exercising such license with respect to Products) in the Field in the Territory and that are not included in Assigned Intellectual Property or licensed under the Assigned Agreements ("**Licensed Intellectual Property**"), Seller hereby grants Buyer a non-exclusive license under and to such Licensed Intellectual Property, with the right to grant sublicenses through multiple tiers, for the sole purpose of researching, developing, making, having made, using and importing Program Molecules and researching and developing, making, having made, using, selling, offering for sale, and importing Products in the Field in the Territory; provided, that Licensed Intellectual Property does not include any Patent Rights or Know-How that relate to a Program Molecule or Product in combination with a Takeda Compound. Each sublicense shall be consistent with the terms and conditions of this Agreement, including requiring each such sublicensee to protect and keep confidential any Confidential Information of the Parties in accordance with <u>Article 7</u> of this Agreement. For clarity, Licensed Intellectual Property, other than <u>Section 2.5(b)</u> IP, does not include Patent Rights or Know-How owned by Seller or its Affiliate that solely relate to any Program Molecule, which is included in Assigned Intellectual Property. <u>Schedule 2.6</u> sets forth the Licensed Intellectual Property as of the Closing Date; such schedule may be updated by the Parties from time to time. Without limiting the foregoing, with respect to Patent Rights included in <u>Section 2.5(b)</u> IP, Buyer shall have the right to notify Seller that it desires to obtain an exclusive license with respect thereto for the sole purpose of researching, developing, making, have made, using and importing Program Molecules and researching and developing, making, having made, using, selling, offering for sale, and importing Products in the Field in the Territory, and upon receipt of any such notification the Parties shall negotiate in good faith [\*\*\*] for such an exclusive license to the extent that Seller has the right and ability to grant such a license; provided that neither Party has an obligation to enter into any such exclusive license.

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Exhibit 10.21

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.7 Post-Closing Liabilities.** Subject to the terms and conditions of this Agreement, including <u>Section 3.5.3</u>, on the Closing Date, Buyer shall assume and, in any event, otherwise agrees to pay, perform and discharge all Liabilities arising (a) under the Assigned Agreements on or after the applicable Assignment Date as a result of activities performed under any such Assigned Agreements on or after the applicable Assignment Date, (b) or resulting from the research, development, making, having made, using, and importing or other exploitation of the Products or other Acquired Assets by or on behalf of Buyer, to the extent that such Liability arises from any event, condition or circumstance occurring on or after the Closing Date, and (c) or resulting from Buyer's breach of <u>Section 3.6</u> with respect to Related Agreements, except in each case (a), (b) and (c) to the extent such Liabilities arise or result from the Seller's or its Affiliate's or its or their (sub)licensee's (other than Buyer's or its Affiliate's or its or their (sub)licensee's) act or omission] (the "**Post-Closing Liabilities**").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.8 Excluded Liabilities.** Subject to the terms and conditions of this Agreement, including <u>Section 3.5.3</u>, on the Closing Date Seller shall retain, and shall be responsible for paying, performing and discharging when due, and Buyer shall not assume or have any responsibility for paying, performing or discharging, any Liabilities of Seller and its Affiliates other than the Post-Closing Liabilities to the extent that such Liabilities do not arise or result from the Seller's or its Affiliate's or its Affiliate's or its or their (sub)licensee's acts or omissions (the "**Excluded Liabilities**"). Without limiting the foregoing, neither Buyer nor its Affiliates shall be obligated to assume, and none of them do assume, and each of them hereby disclaims responsibility for, any of the following Liabilities of Seller and its Affiliates to the extent that such Liabilities do not arise or result from the Buyer's or its Affiliate's or its or their (sub)licensee's (other than Seller's or its Affiliate's or its or their (sub)licensee's) acts or omissions:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.8.1** any Liabilities of Seller or any of its Affiliates attributable to any asset, property or right that is not included in the Acquired Assets or Licensed Intellectual Property;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.8.2** any Liabilities of Seller or any of its Affiliates attributable to the research, development, making, having made, using, and importing or other activity by Seller or any Affiliate related to the Acquired Assets on or prior to the Closing Date (except for Assigned Agreements, which will be on or prior to the applicable Assignment Date), including any obligations to pay for goods and services incurred in the ordinary course of the Program as a result of activities performed or failed to be performed prior to the Closing Date (or the applicable Assignment Date);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.8.3** any Liabilities of Seller or any of its Affiliates attributable to its use or exercise of the licenses set forth in <u>Section 2.5</u>;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.8.4** all Liabilities of Seller or any of its Affiliates for Seller Taxes;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.8.5** all Liabilities of Seller or any of its Affiliates arising under the Related Agreements; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.8.6** all Liabilities of Seller or any of its Affiliates accrued under the Assigned Agreements as a result of activities performed under any such Assigned Agreements prior to the applicable Assignment Date or as a result of any failure to perform any obligations of Seller or any of its Affiliates under any such Assigned Agreements prior to the applicable Assignment Date to the extent that such Liabilities are not attributable to any failure by Buyer or any of its Affiliates to comply with the terms thereof on or after the applicable Assignment Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.9 Adverse Events.** From and after the transfer of the IND and the global safety database for the Products, which occurred on [\*\*\*], Buyer assumed all responsibility for reporting adverse events involving the Products arising on or after such transfer or otherwise known to Buyer to the applicable

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Exhibit 10.21

Governmental Entity as promptly as practicable and in any event in the timeframe required by Law. Following the Closing Date, the Parties entered into the memorandum of understanding attached hereto as <u>Exhibit E</u> to facilitate the exchange of safety data from studies relating to a Program Molecule to the extent necessary to permit each Party to satisfy applicable reporting obligations; provided, that, safety data [\*\*\*]; provided, further, however, that if Buyer (or its Affiliate or its or their (sub)licensee) is required by a Regulatory Authority to report any safety data relating solely to a Program Molecule [\*\*\*], Seller will cooperate with Buyer to make such information available to such Regulatory Authority. For further clarity, it is anticipated that any such agreement will only be required for so long as any applicable data or information is required or generated in connection with any Related Agreement or Non-Assignable Contract. In the event Buyer (or its Affiliate or Licensee) is required by a Regulatory Authority to report any safety data relating to a Program Molecule that was the subject of a combination study, the pharmacovigilance / safety data exchange agreement will provide for Seller to cooperate with Buyer to make such information available to Buyer and to such Regulatory Authority.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.10 [INTENTIONALLY OMITTED].**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.11** Later-Discovered Assigned Intellectual Property, Assigned Agreements and Licensed Intellectual Property. If at any time after the Closing Date, either Party becomes aware of any Assigned Intellectual Property or Licensed Intellectual Property that was not included on the schedules hereto or was not transferred to Buyer, or any Contract to which Seller or its Affiliate is a Party that relates solely to the Program and is not included in the Assigned Agreements (and is not otherwise expressly identified as a Related Agreement), such Party shall notify the other Party, and Seller shall promptly thereafter take actions reasonably necessary to transfer such Assigned Intellectual Property to Buyer, to assign such Contract to Buyer and with respect to Licensed Intellectual Property, to enable Buyer to exploit its rights thereto pursuant to this Agreement. Any such assigned Contract will be deemed an Assigned Agreement. If at any time after the Closing Date, either Party becomes aware of any asset that was transferred to Buyer as an Acquired Asset but is ultimately determined to be an Excluded Asset, or Buyer is found to be in possession of any Excluded Asset, such Party shall notify the other Party, and Buyer shall promptly thereafter take actions reasonably necessary to transfer such Excluded Asset(s) to Seller.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.12** Approval [\*\*\*]. Prior to [\*\*\*] Buyer shall not [\*\*\*], without Seller's prior written approval of [\*\*\*], which shall not be unreasonably withheld, conditioned or delayed. From and after the second anniversary of the Closing Date, Seller will no longer have such approval right.

**ARTICLE 3**<br>**DEVELOPMENT AND COMMERCIALIZATION OF PRODUCTS; ONGOING OBLIGATIONS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.1 Responsibility.** Buyer shall have the sole right and responsibility, at its sole cost and expense, for the conduct, itself or with or through any Affiliate or Licensee, of all research, development, regulatory, manufacturing and commercialization activities applicable to the Program Molecule or any Product for use in the Field and in the Territory after the Closing Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.2 Diligence.** Buyer shall use Commercially Reasonable Efforts to research and develop, including to obtain Regulatory Approval for, and upon obtaining Regulatory Approval to commercialize at least one (1) Product in each of the United States, Japan and at least three (3) of the EU 5 Countries. Buyer shall (a) perform its obligations in good scientific manner and in compliance with all applicable Law in all material respects and (b) notify Seller in writing if it and its Affiliates and Licensees (i) have determined to permanently discontinue, or (ii) plan to halt for [\*\*\*] or realize that a [\*\*\*] halt has occurred with respect to, all research, development and/or commercialization activities and efforts with respect to all Products. Seller may deliver Buyer a written notice if it believes Buyer has breached its obligation under this <u>Section</u> 

------

Exhibit 10.21

<u>3.2</u>, setting forth the basis for such belief, and Buyer shall respond to such notice with a written description of the activities it is conducting with respect to its obligations under this <u>Section 3.2</u> within [\*\*\*] of receipt of such notice.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.3 Reports.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.3.1 Records; Reports.** Buyer shall (a) maintain records of its research, development, manufacture and commercialization activities with respect to the Program Molecules and Products under this Agreement in sufficient detail and in good scientific manner, which shall reflect work performed and results achieved in the conduct of such research, development, manufacture and commercialization activities, and (b) keep Seller reasonably informed regarding the research, development and manufacturing activities conducted with respect to Program Molecules and Products by providing Seller with [\*\*\*]) reports until [\*\*\*] summarizing the activities undertaken by Buyer, its Affiliates and its Licensees since the last report and providing the then-current Development Plan with respect to its future research and development to be undertaken (each, a "**Report**"); provided that, at Seller's sole discretion, Seller may provide written notice to Buyer prior to the due date of any Report that it does not wish to receive such Report and Buyer shall cease providing Reports until such time, if ever, that Seller provides written notice Buyer that it desires to start receiving the Reports again, at which time Buyer shall again begin providing Reports in accordance with this <u>Section 3.3.1</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.3.2 Content of Reports.** Each Report provided pursuant to <u>Section 3.3.1</u> will include at least information regarding: (a) completed activities with respect to the research and development of Program Molecules and Products during the applicable reporting period [\*\*\*]; and (b) the [\*\*\*] actual date, as applicable, of the First Commercial Sale of each Product in each country of the Territory. In addition, on a Product-by-Product basis, on an annual basis commencing on or about [\*\*\*] of the first Calendar Year following the first Calendar Year during [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.3.3** At least [\*\*\*] prior to initiating (or publicly announcing, if earlier) any clinical trial of a Product sponsored by Buyer, its Affiliate or its Licensee, or sponsored by a Third Party and for which Buyer, its Affiliate or its Licensee supplies Program Molecule, that involves one (1) or more of Seller's or its Affiliate's products (marketed or otherwise), Buyer shall report to Seller in writing of such intention and name the relevant product(s) and the Product(s) it intends to use in such clinical trial.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.4 Audit.** Buyer will keep complete and accurate records of Buyer and its Affiliates in reasonably sufficient detail to permit Seller to confirm the accuracy of the calculation of earn-out payments under <u>Section 5.2</u> and Sales Milestone Payments under <u>Section 5.4</u> for [\*\*\*] years after the Calendar Year to which such records pertain. At the request of Seller, Buyer shall permit an independent auditor designated by Seller and reasonably acceptable to Buyer, at reasonable times and upon reasonable notice, to audit the books and records maintained pursuant to the preceding sentence to ensure the accuracy of all financial reports and payments made hereunder. Such examinations may not be conducted more than once in any [\*\*\*] period (unless a previous audit during such [\*\*\*] period revealed a failure to pay Sales Milestone Payments or an underpayment of more than [\*\*\*] from the reported amounts with respect to such period) and may not include records previously audited under this <u>Section 3.4</u> (unless such previously audited records revealed a failure to pay Sales Milestone Payments or an underpayment of more than [\*\*\*] from the reported amounts with respect to such period). Such auditor shall enter into a confidentiality agreement with Buyer and shall not disclose Buyer's confidential information, except (a) to disclose the findings and results of the audit to Seller and (b) to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by Buyer or the amounts of such payments due by Buyer under this Agreement. Except as provided below, the cost of this audit shall be borne by Seller, unless the audit reveals an under-reporting by Buyer of more than [\*\*\*] from the amounts due for the audited period, in which case Buyer shall bear the cost of the audit.

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Exhibit 10.21

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.5 Assumption of Rights and Obligations under Assigned Agreements.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.5.1** Buyer acknowledges that certain intellectual property is in-licensed under the Assigned Agreements and that the practice of such in-licensed intellectual property will be subject to the terms and conditions of the applicable Assigned Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.5.2** Buyer acknowledges and agrees that [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.5.3** [INTENTIONALLY OMITTED].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.6 Related Agreements.** Agreements to which Seller or its Affiliate is a party that relate to a Program Molecule but that are not included in the Assigned Agreements are referred to herein as "Related Agreements" and are, to the extent Known by Seller to have been identified by Seller as of the Closing Date, set forth in <u>Schedule 3.6</u>. Seller shall provide to Buyer, promptly after receipt thereof, all data related to any Program Molecule that is generated under the Related Agreements and that Seller receives from a given counterparty to any such Related Agreement, which data will be included in the Assigned Know-How or Licensed Intellectual Property, as applicable; provided, that except as follows, Seller shall not be obligated to provide any data involving [\*\*\*]. Upon Buyer's request, Seller will provide to Buyer copies of any data Controlled by Seller that is related to a Program Molecule [\*\*\*]. In addition, Seller shall use commercially reasonable efforts to maintain the Related Agreements in full force and effect in accordance with their terms and conditions and without any further amendment that would adversely affect the rights of Buyer as contemplated herein, except with Buyer's prior written consent. Buyer shall assist Seller in Seller's performance of the Related Agreements, as and to the extent reasonably requested by Seller, including supplying Product; provided, that if Seller requests Buyer's assistance in excess of [\*\*\*], then Seller shall reimburse Buyer for internal costs (calculated by reference to the number of hours of support provided at the hourly FTE Rate) incurred by Buyer or its Affiliates to provide such excess assistance. Seller shall pay such costs as such may be invoiced by Buyer to Seller from time-to-time within [\*\*\*] of receipt of such an invoice. If Buyer reasonably requests that Seller supply Product for purposes of performing Seller's obligations under the Related Agreement, then the Parties shall promptly negotiate appropriate terms and conditions to govern such supply (including providing such Product at no charge).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.7 Non-Assignable Contract.** If any Contract that solely relates to the Program (other than Related Agreements) is not assignable or transferable (each, a "**Non-Assignable Contract**") without the consent of, or waiver by, a Third Party or action by a Governmental Entity (each, an "**Assignment Consent**"), either as a result of the provisions thereof or applicable Laws, and any such Assignment Consent is not obtained on or prior to the Closing Date, then this Agreement and the related instruments of transfer shall not constitute an assignment or transfer of such Non-Assignable Contract and such Non-Assignable Contract shall not be included in the Acquired Assets unless and until such Assignment Consent is obtained. To the extent such Assignment Consent is obtained, Seller hereby sells, conveys, assigns, transfers and delivers to, and shall cause its Affiliates to sell, convey, assign, transfer and deliver to, Buyer, and Buyer hereby purchases and acquires from each of Seller or its Affiliates, such Non-Assignable Contract. Following any such assignment, such Non-Assignable Contract shall be deemed an Assigned Agreement and Acquired Asset for purposes of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.8 Cooperation in Combination Clinical Study(ies).** Upon Seller's request, the Parties shall negotiate in good faith the terms under which the Parties would conduct one (1) or more combination clinical study(ies) involving a Product and one (1) or more products of Seller, such terms to include, unless otherwise agreed by the Parties, rights of access to, ownership of and terms related to data ownership and use (which will not be subject to the terms of this Agreement), having Seller be the sponsor of such combination clinical study(ies), terms for the supply of Product by Buyer and applicable products of Seller

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Exhibit 10.21

and grant of the appropriate licenses in order to conduct such study(ies). Buyer shall not be obligated to [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.9 Delayed Assignment of Contracts for Clinical Studies.** The Parties agree that any Contract listed on <u>Schedule 3.9</u> (a "**Delayed Assigned Contract**") has been assigned to Buyer as of the date on which the IND for such Program Molecule was transferred to Buyer (the "**Assignment Date**" for such Assigned Agreement). Seller hereby sells, conveys, assigns, transfers and delivers to, and shall cause its Affiliates to sell, convey, assign, transfer and deliver to, Buyer, and Buyer hereby purchases and acquires from each of Seller or its Affiliates, as of the applicable Assignment Date, each Delayed Assigned Contract. From and after the Assignment Date for any Delayed Assigned Contract, such Delayed Assigned Contract shall be deemed an Assigned Agreement. For any Assigned Agreement that is assigned on the Closing Date, the Assignment Date for such Assigned Agreement will be the Closing Date.

**ARTICLE 4**<br>**CONTROL OF ASSIGNED PATENT RIGHTS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.1 Control of Assigned Patent Rights.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.1.1** From and after the Closing, Buyer, acting through patent counsel or agents of its choice, shall be solely responsible, in its sole discretion, for the preparation, filing, prosecution, maintenance, defense and enforcement of all Assigned Patent Rights throughout the Territory. All patent costs and expenses incurred by Buyer in connection with the preparation, filing, prosecution, maintenance, defense and/or enforcement of such Assigned Patent Rights shall be the sole responsibility of Buyer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.1.2** Buyer shall provide Seller at least [\*\*\*] an updated <u>Schedule 1.1(h) – Part 1</u> and <u>Schedule 1.1(h) – Part 2</u> showing the status of all Assigned Patent Rights and In-Licensed Patent Rights, respectively.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.1.3** If Buyer decides to [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.2** Control of Licensed Intellectual Property. Buyer will have no review, comment or step-in rights with respect to preparation, filing, prosecution, maintenance, defense or enforcement of any Licensed Intellectual Property. Seller shall be solely responsible, in its sole discretion, for such activities with respect to any Licensed Intellectual Property. If Seller discontinues the prosecution or maintenance of a patent application or patent within the Licensed Intellectual Property in any country or jurisdiction, then Seller shall provide Buyer with notice of such decision via [\*\*\*] update (as and to the extent such update is needed to provide notice of any such discontinuance).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.3** Ownership of Transaction IP. Ownership of any discovery or invention and intellectual property rights with respect thereto, developed through, or obtained in connection with, the performance of this Agreement or any Ancillary Agreements, but excluding any such discovery, invention and intellectual property rights that arise from the practice of the license granted pursuant to clause (b) of <u>Section 2.5</u> ("**Transaction IP**") will be allocated based on inventorship in accordance with United States patent law. Seller's or its Affiliate's interest in any Transaction IP, and Seller's or its Affiliate's interest in any Know-How or Patent Rights it Controls pursuant to a Non-Assignable Contract or Related Agreement, shall be deemed to be either (a) Assigned Intellectual Property, to the extent owned by Seller or its Affiliate and solely relating to any Program Molecule (and thus assigned to Buyer pursuant to this Agreement), or (b) Licensed Intellectual Property, to the extent not solely relating to any Program Molecule (and thus licensed to Buyer pursuant to <u>Section 2.6</u> of this Agreement) or in-licensed by Seller or its Affiliate.

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Exhibit 10.21

**ARTICLE 5**<br>**PURCHASE PRICE AND OTHER PAYMENTS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.1 Upfront Consideration Acknowledgement.** In partial consideration for the rights granted herein and under the amended and restated agreement between the parties (as of the same date as this Agreement) pertaining to the TAK-659 Product, including rights to the Acquired Assets, Buyer (a) paid Seller on the Closing Date an amount in cash equal to Ten Million Dollars ($10,000,000) by wire transfer of immediately available funds to the account(s) designated by Seller, and [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.2 Payment of Earn-out Payments; Earn-Out Rates.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.2.1 Earn-out Payment.** From and after the Closing, Buyer shall pay Seller an earn-out payment on the Annual Net Sales of all Products by or on behalf of Buyer, its Affiliates, or Licensees in a given Calendar Year (or partial Calendar Year), on a Product-by-Product basis, commencing with the First Commercial Sale of such Product in any country in the Territory, at the following rates:

---

| | |
|:---|:---|
| &nbsp;&nbsp;**<u>Annual Net Sales Increment</u>** | &nbsp;&nbsp;**<u>Earn-Out Payment Rate (%)</u>** |
| &nbsp;&nbsp;For the portion of the Annual Net Sales of such Product in any given Calendar Year which is less than or equal to [\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;For the portion of the Annual Net Sales of such Product in any given Calendar Year which is greater than [\*\*\*] but less than or equal to [\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;For the portion of the Annual Net Sales of such Product in any given Calendar Year which is greater than [\*\*\*] but less than or equal to [\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;For the portion of the Annual Net Sales of such Product in any given Calendar Year which is greater than [\*\*\*] but less than or equal to [\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;For the portion of the Annual Net Sales of such Product in any given Calendar Year which is greater than [\*\*\*] | &nbsp;&nbsp;[\*\*\*] |

---

For purposes of clarity, (a) each earn-out payment rate will only apply to the corresponding tier of Annual Net Sales, and (b) the determination of the earn-out payment rate under this <u>Section 5.2.1</u> shall be based on aggregate, worldwide Annual Net Sales of the relevant Products in each Calendar Year.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.2.2 Expiration of Earn-Out Payments.** Such earn-out payments shall be payable on a Product-by-Product and country-by-country basis commencing upon the First Commercial Sale of such Product in such country in the Territory and continuing until the latest of (a) the expiration of the last-to-expire Valid Claim of the Assigned Patent Rights, [\*\*\*] and the In-Licensed Patent Rights covering or claiming such Product in such country, (b) expiration of Regulatory Exclusivity for such Product in such country, and (c) ten (10) years after First Commercial Sale of such Product in such country. Upon the expiration of the earn-out payment term with respect to a Product and a country, the license to Buyer under the Licensed Intellectual Property for such Product and in such country shall become fully-paid, perpetual and irrevocable.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.2.3 Earn-Out Payment Reduction.**

------

Exhibit 10.21

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)** On a Product-by-Product and country-by-country basis, if a Product is sold in a country in a Calendar Quarter when one (1) or more Generic Products for such Product are being sold in such country and such Generic Products account for at least [\*\*\*] of the total [\*\*\*] of both such Generic Products and such Product in such country for such Calendar Quarter, then, subject to <u>Section 5.2.3(c)</u> below, the earn-out payment applicable to the Net Sales of such Product sold in such Calendar Quarter shall be reduced by [\*\*\*]. The determination of the units of the Generic Product(s) sold shall be based upon data provided by IQVIA (formerly IMS Health) or another mutually acceptable and reputable provider.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** Buyer shall bear all costs associated with securing licenses (that are in addition to any licenses under an Assigned Agreement) to any Third Party Patent Rights necessary to research and develop, make, have made, use, sell, offer for sale, or use any Product in the Territory. If it is necessary for Buyer to obtain or maintain a license from a Third Party to any Patent Rights owned by such Third Party (that are in addition to any licenses under an Assigned Agreement) in order to avoid infringement of such Patent Right [\*\*\*] in the research and development, making, having made, using, selling, offering for sale, or importing or other exploitation of any Program Molecule or Product (excluding the part of a Combination Product that is not a Program Molecule or Product) in a country in the Territory and Buyer obtains or maintains such a license, then, subject to <u>Section 5.2.3(c)</u> below, Buyer shall have the right to deduct, from the earn-out payment that would otherwise have been due pursuant to <u>Section 5.2.1</u> with respect to Net Sales of such Product in such country in a particular Calendar Quarter, an amount equal to [\*\*\*] of the royalties paid by or on behalf of Buyer to such Third Party pursuant to such license on account of the sale of the Product in such country during such Calendar Quarter, provided that Buyer shall have the right to carry forward to subsequent Calendar Quarters any unused balance of such reductions that is not used in a given Calendar Quarter as a result of <u>Section 5.2.3(c)</u>. Notwithstanding the foregoing, for any Calendar Quarter in which the reduction under <u>Section 5.2.3(a)</u> applies, the reduction under this <u>Section 5.2.3(b)</u> for Third Party royalties paid during such Calendar Quarter may not be taken (on account of the floor under <u>Section 5.2.3(c)</u>) and may not be carried forward to subsequent Calendar Quarters. For clarity, payments under any Assigned Agreement are not deductible under this <u>Section 5.2.3(b)</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c)** Notwithstanding the foregoing <u>Sections 5.2.3(a)</u> and <u>5.2.3(b)</u>, in no event shall the aggregate earn-out payments payable under this <u>Section 5.2</u> in a given Calendar Quarter with respect to a Product be reduced pursuant to <u>Sections 5.2.3(a)</u> and <u>5.2.3(b)</u> by more than [\*\*\*] cumulatively from the amounts that would otherwise be due if no such reductions applied.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.2.4 Earn-Out Payments and Reporting.** Buyer shall calculate all amounts payable to Seller pursuant to <u>Section 5.2</u> at the end of each Calendar Quarter. Buyer will deliver to Seller (a) [\*\*\*] and (b) within [\*\*\*] after the end of each Calendar Quarter, a written report setting forth the actual Net Sales for such Calendar Quarter and including the following information for such Calendar Quarter: [\*\*\*] (each, an "**Earn-Out Report**"). Upon receipt of such Earn-Out Report, Seller will issue an invoice to Buyer for the amount of the earn-out payments payable under this <u>Section 5.2</u> set forth in such Earn-Out Report, which invoice will specify the amount of the earn-out payments payable under this <u>Section 5.2</u> that should be made to Seller. Buyer will pay all earn-out payments payable under this <u>Section 5.2</u> for a Calendar Quarter set forth in any such invoice within [\*\*\*] after receipt of such invoice.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.3 Development Milestone Payments**. From and after the Closing, following the first achievement of each development milestone event set forth in the table below (each such event, a "**Development Milestone Event**"), Buyer shall pay, or cause to be paid, to Seller a one-time, non-refundable and non-creditable corresponding milestone payment (each, a "**Development Milestone Payment**") within [\*\*\*] after receipt of invoice from Seller issued on or after the first achievement of such Development Milestone Event. Buyer shall notify Seller within [\*\*\*] after each Development Milestone Event is first achieved. For the avoidance of doubt, each Development Milestone Payment shall be payable one (1) time only for all Products upon the first achievement of the corresponding Development Milestone

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Exhibit 10.21

Event, regardless of the number of times such Development Milestone Event may be achieved by the same or different Products. As used in the table below, "Indication" means an individual, separate and distinct disease or medical condition for which (a) at least one clinical trial is required to support inclusion of such disease or condition in the indication statement of a package insert approved by a Regulatory Authority for a Product or (b) a separate Marketing Authorization Application (or amendment or supplement thereto) must be filed. Indications of the same cancer type shall be deemed the same Indication unless they (i) have different organs of origin (e.g., gastric cancer and renal cancer would be different Indications), or (ii) are for a different hematological malignancy as classified by IDC10 codes (e.g., acute lymphoblastic leukemia, chronic myelogenous leukemia, non-Hodgkin's lymphoma, multiple myeloma, Hodgkin's disease, chronic lymphocytic leukemia and acute myeloid leukemia are all different Indications); provided that [\*\*\*]

---

| | |
|:---|:---|
| &nbsp;&nbsp;**<u>Development Milestone Payments</u>** | &nbsp;&nbsp;**<u>Development Milestone Payments</u>** |
| &nbsp;&nbsp;**Development Milestone Event** | &nbsp;&nbsp;**[\*\*\*]** |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;**Total Development Milestones** | &nbsp;&nbsp;**[\*\*\*]** |

---

[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.4 Sales Milestone Payments.** From and after the Closing, following the first achievement of each sales milestone event set forth in the applicable table below with respect to aggregate Annual Net Sales of all Products (each such event, a "**Sales Milestone Event**"), Buyer shall pay, or cause to be paid, to Seller a one-time, non-refundable and non-creditable corresponding milestone payment (each, a "**Sales Milestone Payment**"). The [\*\*\*] and the Earn-Out Report to be issued pursuant to <u>Section 5.2.4</u> shall each indicate whether any Sales Milestone Event was achieved during the Calendar Quarter covered by such report. Upon receipt of an Earn-Out Report indicating that a Sales Milestone Event was achieved, Seller will issue an invoice to Buyer for the Sales Milestone Payment payable under this <u>Section 5.4</u>. Buyer will pay all Sales Milestone Payments payable under this <u>Section 5.4</u> within [\*\*\*] after receipt of such invoice. For the avoidance of doubt, each Sales Milestone Payment shall be payable one time upon the first achievement of the corresponding Sales Milestone Event, regardless of the number of times such Sales Milestone Event may be achieved.

---

| | |
|:---|:---|
| &nbsp;&nbsp;**<u>Sales Milestones</u>** | &nbsp;&nbsp;**<u>Sales Milestones</u>** |
| &nbsp;&nbsp;**Sales Milestone Event** | &nbsp;&nbsp;**Sales Milestone Payment** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Annual Net Sales of all Products equals or exceeds [\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Annual Net Sales of all Products equals or exceeds [\*\*\*] | &nbsp;&nbsp;[\*\*\*] |

---

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Exhibit 10.21

<u>Annual Net Sales of all Products equals or exceeds [\*\*\*]</u> <u>[\*\*\*]</u> <br> <u>Annual Net Sales of all Products equals or exceeds [\*\*\*]</u> <u>[\*\*\*]</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.5 Payments in Dollars.** All payments made by Buyer under this <u>Article 5</u> shall be made by wire transfer from a banking institution in Dollars in accordance with instructions given in writing from time to time by Seller.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.6 Foreign Currency Exchange.** For the purpose of calculating any sums due under, or otherwise reimbursable pursuant to this Agreement (including the calculation of Net Sales) expressed in currencies other than Dollars, Buyer shall convert any amount expressed in a foreign currency into Dollar equivalents using the exchange rate used by Buyer in its financial reporting in accordance with U.S. GAAP.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.7 Overdue Payments.** Any amounts not paid by Buyer when due shall be subject to interest from and including the date payment is due, through and including the actual date of payment by Buyer, at a rate equal to the sum of [\*\*\*], plus [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.8 Taxes.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.8.1 Taxes on Income.** Each Party shall be solely responsible for, and shall hold the other Party harmless in respect of, the payment of all Taxes, fees, duties, levies or similar amounts imposed on its share of income arising directly or indirectly from the activities of the Parties under this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.8.2 Tax Withholding.** To the extent Buyer is required by applicable Law to deduct and withhold Taxes from the consideration otherwise payable pursuant to this Agreement to Seller, Buyer shall pay the amounts of such Taxes to the proper Governmental Entity in a timely manner and promptly transmit to Seller an official tax certificate or other evidence of such payment sufficient to enable Seller to claim such payment of Taxes within [\*\*\*] following receipt of such evidence; provided, that prior to withholding any Taxes from consideration otherwise payable pursuant to this Agreement, Buyer shall use commercially reasonable efforts to notify Seller of the requirement to so withhold and to cooperate with Seller in Seller's reasonable efforts to eliminate, or mitigate, the amount of such withholding. To the extent that amounts are so withheld and paid to the proper Governmental Authority, such withheld amounts shall be treated for all purposes of this Agreement as having been paid to Seller.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.8.3 Redomicile, Assignment or Sublicense.** Notwithstanding anything in this Agreement to the contrary, the Parties acknowledge and agree that if either Party redomiciles, or assigns or sublicenses its rights or obligations under this Agreement (including an assignment of this Agreement as permitted under this Agreement), and such action leads to the imposition of Tax liability, including withholding or value added tax liability, on the other Party that would not have been imposed in the absence of such action or in an increase in such liability above the liability that would have been imposed in the absence of such action, then if such Party is Buyer, Buyer will increase such payment by the amount necessary to ensure that Seller receives an amount equal to the amount it would have received had no such action occurred.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.8.4 Transfer Taxes**. Unless otherwise agreed by the Parties in writing, the amounts payable under this Agreement are exclusive of all documentary, bulk transfer, sales or use, goods and services, value-added, gross receipts, stamp, registration or other similar transfer taxes, including all recording or filing fees, notarial fees and other similar costs, that may be imposed, payable, collectible or incurred in connection with the transfer and sale of the Acquired Assets as contemplated by the terms of this Agreement ("**Transfer Taxes**"). Such Transfer Taxes shall be borne [\*\*\*]. Where such amounts are subject to Transfer Taxes, Seller shall promptly furnish Buyer with valid Tax invoices pursuant to

------

Exhibit 10.21

applicable Law and remit the amounts of such Taxes to the proper Governmental Entity in a timely manner. Buyer shall settle all undisputed amounts, including any applicable Transfer Taxes, in accordance with <u>Section 9.5</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.8.5 Tax Cooperation**. The Parties agree to cooperate with one another as may be reasonably necessary for the filing of Tax Returns, the making of any election with respect to Taxes, the preparation for any audit by any taxing authority and the prosecution or defense of any action relating to any Tax, and to use reasonable efforts to avoid or reduce Tax withholding, Transfer Taxes, or similar obligations in respect of the payments made by a Party under this Agreement, as permitted by applicable Law. On or prior to the Closing Date, Seller shall deliver to Buyer a properly completed IRS Form W-9 or applicable successor form.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.8.6 Allocation**. To the extent required for United States federal income Tax purposes, the Parties agreed in good faith on the manner in which the consideration referred to in <u>Section 5.1</u> was allocated among the Acquired Assets and the assets acquired under the amended and restated agreement between the parties (as of the same date as this Agreement) pertaining to the TAK-659 Product (the "**Allocation Schedule**"). The Parties agree that the purchase price was allocated among the assets of the Seller for federal and state income Tax purposes in accordance with Section 1060 of the Internal Revenue Code of 1986, as amended (the "**Code**"), and the applicable regulations. No Party hereto shall file any Tax Return or other document with, or make any statement or declaration to, any governmental body that is inconsistent with the Allocation Schedule unless required to do so pursuant to a "determination" within the meaning of Section 1313 of the Code. Buyer and Seller also shall allocate and report any earn-out payments under <u>Section 5.2</u>, Development Milestone Payments or Sales Milestone Payments in accordance with the principles set forth in the Allocation Schedule as such payments are made and shall make appropriate adjustments to the Allocation Schedule.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.8.7 Personal Property Taxes**. All personal property Taxes and similar ad valorem Taxes levied with respect to the Acquired Assets for a Straddle Period shall be apportioned between Seller and Buyer as of the relevant Assignment Date based on the number of days of such taxable period included in the Pre-Closing Tax Period, and the number of days of such taxable period in the Post-Closing Tax Period. Seller shall be liable for the proportionate amount of such Taxes that is attributable to the Pre-Closing Tax Period, and Buyer shall be liable for the proportionate amount of such Taxes that is attributable to the Post-Closing Tax Period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.8.8 Adjustment to Purchase Price**. Any payments made pursuant to <u>Section 5.2</u>, <u>Section 5.3</u>, <u>Section 5.4</u> and <u>Article 9</u> shall constitute an adjustment of the purchase price for Tax purposes and shall be treated as such by Buyer and Seller on their Tax Returns unless otherwise required pursuant to a "determination" within the meaning of Section 1313 of the Code.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.9 Mode of Payment.** All payments under this Agreement to Seller shall be made by deposit in the requisite amount to the bank account of Seller set forth in <u>Schedule 5.9</u> or such other account as Seller may from time to time designate by written notice to Buyer.

**ARTICLE 6**<br>**REPRESENTATIONS AND WARRANTIES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.1 Representations and Warranties of Seller.** Seller represents and warrants to Buyer that the statements in this <u>Section 6.1</u> are true, complete and correct as of the Closing Date (and, with respect to <u>Sections 6.1.1-6.1.3</u>, inclusive and <u>6.1.7</u>, as of the Effective Date), except as and to the extent set forth in <u>Exhibit D</u> (the "**Disclosure Schedule**"):

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Exhibit 10.21

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.1.1 Organization and Standing.** Seller is a corporation duly organized, validly existing and in good standing under the Laws of Delaware.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.1.2 Authorization.** Seller has all requisite power and authority to execute the Original Agreement and this Agreement, to carry out and perform its obligations under the Original Agreement, this Agreement and the Ancillary Agreements and to consummate the transactions contemplated hereunder and thereunder. The execution, delivery and performance by Seller of the Original Agreement, this Agreement and the Ancillary Agreements, and the consummation of the transactions contemplated hereunder and thereunder, have been duly and validly authorized by all necessary action of Seller.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.1.3 Binding Agreement.** The Original Agreement and this Agreement have been, and each of the Ancillary Agreements to which Seller is or will be a party, will be at the Closing and as of the Effective Date, duly and validly executed and delivered on behalf of Seller and, assuming the due authorization, execution and delivery by Buyer, each such agreement constitutes the legal and binding obligation of Seller enforceable against Seller in accordance with its terms, subject to the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar laws relating to or affecting creditors' rights generally and to general equity principles (whether considered in a proceeding in equity or at law).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.1.4 Consents; No Violation, Etc.** The execution and delivery of the Original Agreement and the Ancillary Agreements do not, and the consummation of the transactions contemplated hereby and thereby will not (a) violate any Law applicable to Seller or its Affiliates, (b) conflict with any provision of the certificate of incorporation, bylaws or other organizational documents of Seller, or (c) give rise to any approval, authorization, consent, license, filing or registration with any Court or Governmental Entity or (d) violate any material Contract of Seller, or to which Seller is a party or subject to or by which it or any of its assets or properties is otherwise bound; *provided*, *however*, that no representation or warranty is made in the foregoing clause (a) or (d) with respect to matters that, individually or in the aggregate, would not result in a material adverse effect on the Acquired Assets or the transactions contemplated by the Original Agreement and the Ancillary Agreements.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.1.5 Title to Acquired Tangible Assets.** Seller and its Affiliates have good and valid title, right and interest to the portion of Acquired Assets that constitute tangible property, free and clear of all Encumbrances, other than Permitted Encumbrances.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.1.6 Litigation.** As of the Closing Date, there is no Litigation pending or, to the Knowledge of Seller, threatened in writing against Seller or any of its Affiliates, that (a) challenges the transactions contemplated by the Original Agreement or the Ancillary Agreements or (b) relates specifically to the Acquired Assets or the Program (other than any Litigation related to intellectual property rights) by way of specifically referencing to a Program Molecule or Product.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.1.7 Brokers.** No broker, investment banker, financial advisor or other Person is entitled to any broker's, finder's, financial advisor's or similar fee or commission in connection with the transactions contemplated by the Original Agreement based upon arrangements made by or on behalf of Seller, except those for which Seller will be solely responsible.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.1.8 Intellectual Property.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)** Seller or its Affiliate is (a) the sole owner of the entire right, title and interest in and to the Assigned Patent Rights that are set forth on <u>Schedule 1.1(h) – Part 1</u> as of the Closing Date and (b) the sole owner, or a joint owner with one or more Third Parties, of the entire right, title and

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Exhibit 10.21

interest in and to the Assigned Know-How, in each case free and clear of all Encumbrances, other than Permitted Encumbrances.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** None of the Assigned Patent Rights that are set forth on <u>Schedule 1.1(h) – Part 1</u> as of the Closing Date has been finally adjudged invalid or unenforceable in whole or part, and, to Seller's Knowledge, all such Assigned Patent Rights are valid and enforceable. To Seller's Knowledge, all required filings and fees related to the Assigned Patent Rights that are set forth on <u>Schedule 1.1(h) – Part 1</u> as of the Closing Date have been timely filed with and paid to the relevant Governmental Entity. No Litigation is pending or, to Seller's Knowledge, has been threatened in writing against Seller or any of its Affiliates alleging the invalidity or unenforceability of any of the Assigned Patent Rights that are set forth on <u>Schedule 1.1(h) – Part 1</u> as of the Closing Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c)** Except as set forth in any Assigned Agreement or Related Agreement, neither Seller nor any of its Affiliates has granted any Third Party any rights or authority with respect to any Assigned Intellectual Property.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(d)** The Assigned Agreements are the only Contracts that Seller or its Affiliate is a party to prior to the Closing Date that include any royalty, license fee or other payment obligations with respect to the Program for which Buyer will be liable following the Closing Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(e)** To Seller's Knowledge, there is no unauthorized use, infringement or misappropriation of any of the Assigned Patent Rights that are set forth on <u>Schedule 1.1(h) – Part 1</u> as of the Closing Date or material Assigned Know-How by any Third Party, including any current or former employee or consultant of Seller and its Affiliates.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(f)** The Assigned Intellectual Property and the Patent Rights and Know-How licensed under the Assigned Agreements includes all Patent Rights and Know-How that are owned or in-licensed by Seller or its Affiliates and that relate solely to the Program.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(g)** [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.1.9 Assigned Agreements, Non-Assignable Contracts and Related Agreements.** Except as disclosed in <u>Exhibit D</u>, Seller has delivered to Buyer, prior to the Original Effective Date, true and complete copies of each Assigned Agreement, each Delayed Assigned Contract and each Non-Assignable Contract and Related Agreement that has been identified to the Knowledge of Seller as of the Closing Date. Each Assigned Agreement, Delayed Assigned Contract and Non-Assignable Contract is in full force and effect and valid and enforceable in accordance with its terms, except to the extent that any such agreement has expired in accordance with its terms and conditions (in which case the subject matter to be assigned or performed are the surviving rights and obligations thereunder). Except as disclosed in <u>Exhibit D</u>, neither the Seller nor the applicable Affiliate nor, to the Knowledge of Seller, any other party thereto is in default in the performance, observance or fulfillment of any obligation, covenant, condition or other term contained in any Assigned Agreement, Delayed Assigned Contract or Non-Assignable Contract, and the Seller or applicable Affiliate has not given or received written notice to or from any Person relating to any such alleged or potential default that has not been cured.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.1.10 Regulatory Documentation.** Seller has made available, or will make available as part of the transfer of Acquired Assets, to Buyer true and complete copies of, and the Regulatory Materials including, all registrations, applications, licenses, requests for approvals, exemptions, permits and other regulatory authorizations from the FDA or other Regulatory Authority related to the Program Molecules, Products and Program, other than Regulatory Materials solely related to clinical trials of any Program Molecule or Product in combination with any Takeda Compound.

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Exhibit 10.21

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.1.11 Legal Compliance.** Seller and its Affiliates have conducted all research (excluding non-clinical research that was [\*\*\*]) and development of Program Molecules and Products in compliance with all applicable Laws in all material respects. Seller and its Affiliates have not received any written communication from any Governmental Entity or any written notice, claim, request for information or complaint from any other Person alleging any failure to comply with or any liability under any applicable Laws relating to the Program Molecules, Products or Program, and none is pending or, to Seller's Knowledge, threatened in writing.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.1.12 Existing Inventory.** The Existing Inventory has been stored in accordance with Seller's and its Affiliates' customary practices. Seller has provided Buyer true and complete copies of all batch records and quality documents related to the Existing Inventory.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.1.13 Taxes.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)** Seller is not a foreign person as that term is defined in Treasury Regulations Section 1.1445-2.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** There are no liens upon any of the Acquired Assets due to non-payment of Taxes or similar Tax-related matters, other than for Taxes not yet due and payable or that are being contested in good faith by appropriate proceedings, and no such liens will arise as a result of the execution of the Original Agreement and purchase of the Acquired Assets, other than in respect of Transfer Taxes borne by Buyer pursuant to <u>Section 5.8.4</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.2 Representations and Warranties of Buyer.** Buyer represents and warrants to Seller that the statements in this <u>Section 6.2</u> are true, complete and correct as of the Closing Date (and, with respect to <u>Sections 6.2.1-6.2.4</u>, inclusive and <u>6.2.8</u>, as of the Effective Date):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.2.1 Organization and Standing.** Buyer is a corporation duly organized, validly existing and in good standing under the laws of Delaware.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.2.2 Authorization.** Buyer has all requisite corporate power and authority to execute the Original Agreement, this Agreement and the Ancillary Agreements, to carry out and perform its obligations under the Original Agreement, this Agreement and the Ancillary Agreements and to consummate the transactions contemplated hereunder and thereunder. The execution, delivery and performance by Buyer of the Original Agreement, this Agreement and the Ancillary Agreements, and the consummation of the transactions contemplated hereunder and thereunder, have been duly and validly authorized by all necessary action of Buyer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.2.3 Binding Agreement.** The Original Agreement and this Agreement have been, and each of the Ancillary Agreements to which Buyer is or will be a party, will be at the Closing and as of the Effective Date, duly and validly executed and delivered on behalf of Buyer and, assuming the due authorization, execution and delivery by Seller, each such agreement constitutes the legal and binding obligation of Buyer enforceable against Buyer in accordance with their terms, subject to the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar laws relating to or affecting creditors' rights generally and to general equity principles (whether considered in a proceeding in equity or at law).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.2.4 Consents; No Violations, Etc.** The execution and delivery of the Original Agreement, this Agreement and the Ancillary Agreements do not, and the consummation of transactions contemplated hereby and thereby will not (a) violate any Law applicable to Buyer or its Affiliates, (b) conflict with any provision of the certificate of incorporation, bylaws or other organizational documents of

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Exhibit 10.21

Buyer, (c) give rise to any approval, authorization, consent, license, filing or registration with any Court or Governmental Entity or (d) violate any material Contract of, or to which Buyer is a party or subject to or by which it or any of its assets or properties is otherwise bound; provided, however, that no representation or warranty is made in the foregoing clauses (a) or (d) with respect to matters that, individually or in the aggregate, would not materially interfere with Buyer's performance of its obligations under the Original Agreement, this Agreement and the Ancillary Agreements.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.2.5 HSR.** Buyer, or if different its Ultimate Parent Entity, has determined pursuant to 16 C.F.R. § 801.10 that the acquisition of the Seller's program as of the Closing Date that is focused on developing TAK-659 and the Program does not satisfy the size of transaction jurisdictional test under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ("**HSR Act**"). Unless otherwise defined, capitalized terms in this <u>Section 6.2.5</u> have the meaning set forth in the HSR Act and related regulations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.2.6 Financial Capability.** As of Closing, Buyer has available sufficient cash or other sources of immediately available funds to pay all upfront amounts payable pursuant to <u>Section 5.1</u>, and Buyer's obligations hereunder are not subject to any conditions regarding Buyer's ability to obtain financing for the transactions contemplated by the Original Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.2.7 Litigation.** As of the Closing Date, there is no Litigation pending or, to the knowledge of Buyer, threatened against Buyer or any of its Affiliates, which (a) challenges the transactions contemplated by the Original Agreement, this Agreement or the Ancillary Agreements, (b) if adversely determined, would delay the ability of Buyer to perform its obligations hereunder or (c) would have a material adverse effect on Buyer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.2.8 No Brokers.** No broker, investment banker, financial advisor or other Person is entitled to any broker's, finder's, financial advisor's or similar fee or commission in connection with the transactions contemplated by the Original Agreement or this Agreement based upon arrangements made by or on behalf of Buyer, except those for which Buyer will be solely responsible.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.2.9 Compliance.** Buyer will and it will ensure that its Affiliates, and require that its subcontractors and Licensees (including using commercially reasonable efforts to enforce applicable Contracts against subcontractors and Licensees), will conduct all activities relating to the Program and/or Product in compliance with applicable Law in all material respects, including applicable Law concerning data privacy and security (e.g., relating to medical records and medical information privacy that regulate or limit the maintenance, use, disclosure or transmission of medical records, patent information or other personal information).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.2.10 Adequacy of Information.** Buyer acknowledges and agrees that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)** other than the representations and warranties expressly set forth in <u>Section 6.1</u>, it has not relied on any representation or warranty made by Seller or any of its employees, agents, stockholders, Affiliates or representatives, express or implied, at Law or in equity, regarding the Program, Products, the Acquired Assets or the subject matter of this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** it will not assert any claim against Seller or any of its employees, agents, stockholders, Affiliates or any representatives or hold Seller or any such Persons liable for any inaccuracies, misstatements or omissions with respect to information furnished by Seller or any of its employees, agents, stockholders, Affiliates or any representatives, including any information in any "on-line" or physical data rooms or in any management presentations; and

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Exhibit 10.21

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c)** Seller makes no warranty with respect to the accuracy and completeness of any estimates, projections, forecasts, plans, budgets, future financial condition or any financial statements made available by Seller to Buyer.

For clarity, this <u>Section 6.2.10</u> does not mitigate Seller's indemnification obligation pursuant to <u>Article 9</u> for breach of representations and warranties expressly set forth in <u>Section 6.1</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.3 Covenant of Buyer.** During the Term, Buyer will [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.4 No Other Warranties.** EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES EXPRESSLY SET FORTH IN THIS <u>ARTICLE 6</u>, BOTH PARTIES DISCLAIM ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, WITH REGARD TO THE PROGRAM, PRODUCTS, THE ACQUIRED ASSETS AND THIS AGREEMENT, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY AND NON-INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS.

**ARTICLE 7**<br>**CONFIDENTIALITY**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.1 Confidentiality Obligations.** At all times during the Term, and for a period of [\*\*\*] thereafter, each Party shall, and shall cause its Affiliates, officers, directors, employees and agents to, keep confidential and not publish or otherwise disclose to a Third Party and not use, directly or indirectly, for any purpose, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by or on behalf of the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Agreement or is reasonably necessary or useful for the performance of such Party's obligations, or the exercise of such Party's rights, under this Agreement. "**Confidential Information**" of a Party means any technical, business, or other information provided by or on behalf of such Party to the other Party in connection with this Agreement or the Original Agreement, whether prior to, on, or after the Closing Date, including information relating to the terms of the Original Agreement or the terms of this Agreement, the Program or Products (including the Acquired Assets), any research, development, making, having made, using, selling, offering for sale, and importing or other exploitation of the Program Molecules or Products; provided that (a) the terms of this Agreement and the terms of the Original Agreement will be deemed the Confidential Information of each Party, (b) any data from studies relating to a Program Molecule [\*\*\*] will be deemed the Confidential Information of Seller, and (c) from and after the Closing Date, the Assigned Know-How and all information related solely to the Program Molecules, Products and Program will be deemed, as between the Parties, the Confidential Information of Buyer and not of Seller, and <u>Sections 7.1.2</u> and <u>7.1.4</u> will not apply with respect thereto. Each Party may disclose the other Party's Confidential Information for the purposes of performing its obligations or exercising its rights hereunder only to those of its and its Affiliates' employees, agents and contractors who require access thereto for the purpose of this Agreement and who are subject to written obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this <u>Article 7</u>. Notwithstanding the foregoing, the confidentiality and non-use obligations under this <u>Section 7.1</u> with respect to any Confidential Information shall not include any information of the disclosing Party that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.1.1** is or hereafter becomes part of the public domain by public use, publication (including by a Third Party), general knowledge or the like through no wrongful act, fault or negligence on the part of the receiving Party in breach of this Agreement;

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Exhibit 10.21

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.1.2** can be demonstrated by documentation or other competent proof to have been in the receiving Party's possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.1.3** is subsequently received by the receiving Party from a Third Party lawfully in possession thereof who is not bound by any obligation of confidentiality with respect to such information; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.1.4** can be demonstrated by documentation or other competent evidence to have been independently developed by or for the receiving Party without reference to or use of the disclosing Party's Confidential Information.

Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination and its principles are in the public domain or in the possession of the receiving Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.2 Permitted Disclosures.** Notwithstanding anything to the contrary, Seller may disclose such Confidential Information that it deems necessary or desirable to comply with any disclosure or reporting obligations set forth in the Related Agreements, provided that each recipient is subject to written obligations of confidentiality and non-use with respect to such Confidential Information. In addition, each Party may disclose Confidential Information to the extent that such disclosure is:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.2.1** made by or on behalf of Buyer to the Governmental Entities as required in connection with any filing, application or request for Regulatory Approval of a Product; *provided*, *however*, that reasonable measures shall be taken to assure confidential treatment of such information to the extent practicable and consistent with applicable Law;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.2.2** made in response to a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental or regulatory body of competent jurisdiction or, if in the reasonable opinion of the receiving Party's legal counsel, such disclosure is otherwise required by applicable Law (including, for clarity, any disclosure required by applicable Law on clinicaltrials.gov or disclosure required by reason of filing with securities regulators, in which case, <u>Section 7.4</u> shall also apply to such disclosure); *provided*, *however*, that to the extent practicable and not otherwise prohibited by applicable Law, the receiving Party shall first have given notice to the disclosing Party and given the disclosing Party (a) a reasonable opportunity to quash such order or to obtain a protective order or confidential treatment requiring that the Confidential Information and documents that are the subject of such order be held in confidence by such court or agency or, if disclosed, be used only for the purposes for which the order was issued and (b) a right to review and comment upon such disclosure, which comments shall be considered in good faith by the receiving Party; and *provided further* that the Confidential Information disclosed in response to such court or governmental order shall be limited to that information which is legally required to be disclosed in response to such court or governmental order;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.2.3** made by or on behalf of Buyer or Seller to a patent authority as may be reasonably necessary or useful for purposes of obtaining or enforcing an Assigned Patent Right (in the case of Buyer) or [\*\*\*] (in the case of Seller); *provided*, *however*, that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such protection is available; or

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Exhibit 10.21

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.2.4** made (a) by the receiving Party to its or its Affiliates' attorneys, auditors, advisors, consultants, contractors, existing or prospective acquirers, as may be necessary or useful in connection with the performance of its obligations or exercise of its rights as contemplated by this Agreement, or (b) by Buyer to existing or prospective collaboration partners, licensees, or other Third Parties, as may be necessary or useful in connection with the research, development, making, having made, using, selling, offering for sale, and importing or other exploitation of the Program Molecules or the Products; *provided*, *however*, that in each case (a) and (b) such persons shall be subject to written obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this <u>Article 7</u> (with a duration of confidentiality and non-use obligations as appropriate that is no less than [\*\*\*] from the date of disclosure).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.3 Use of Name.** Except as expressly provided in this Agreement, neither Party shall mention or otherwise use the name, logo, or trademark of the other Party or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity without the prior written approval of such other Party in each instance. The restrictions imposed by this <u>Section 7.3</u> shall not prohibit either Party from making any disclosure identifying the other Party that is required by applicable Law.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.4 Public Announcements.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.4.1** The Parties acknowledge that promptly following the Closing Date, Buyer issued a press release announcing the transactions contemplated in the Original Agreement, which press release was in substantially the form of <u>Exhibit C</u> attached hereto. Other than the press release described in the preceding sentence, neither Party shall issue any other public announcement, press release, or other public disclosure regarding this Agreement or its subject matter without the other Party's prior written consent, except for any such disclosure that is, in the opinion of the disclosing Party's legal counsel, required by applicable Law or the rules of a stock exchange on which the securities of the disclosing Party or any of its Affiliates are listed (or to which an application for listing has been submitted). For clarity, the foregoing does not apply to public disclosures by Buyer regarding the plans for or results of its activities under this Agreement, which Buyer may make at its sole discretion without review or approval by Seller; provided, that Buyer shall not include in any press release, or otherwise publish or present on, any data, findings or results from studies relating to a Program Molecule in combination with a Takeda Compound or as the Parties may otherwise agree pursuant to <u>Section 7.4.3</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.4.2** In the event a Party or its Affiliates is, in the opinion of its legal counsel, required by applicable Law or the rules of a stock exchange on which its or its Affiliate's securities are listed (or to which an application for listing has been submitted) to make such a public disclosure, such Party shall submit the proposed disclosure in writing to the other Party [\*\*\*] prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment thereon; *provided*, *however*, if a Party or its Affiliates is required by applicable Law or the rules of a stock exchange to disclose this Agreement, such Party shall prepare a proposed redacted version of this Agreement, as applicable, to request confidential treatment for this Agreement, as applicable, and the other Party may [\*\*\*] provide its comments, which comments shall be considered in good faith and reasonably incorporated by the Party required to make such disclosure.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.4.3** Subject to the prior review and written approval of Buyer, such approval not to be unreasonably withheld, delayed or conditioned, Seller may publish and present in scientific conferences or journals the result of Seller's development of Program Molecules conducted prior to the Closing Date. From time-to-time, the Parties may discuss in good faith any publications or presentations that Seller desires to publish or present (which shall be subject to the preceding sentence), such discussion to include the timing, content and venue of such proposed publications or presentations and any potential limitations on Buyer's public disclosure of data, findings or results to be included in such publications or presentations. Buyer

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Exhibit 10.21

shall not publicly disclose any draft publication or presentation provided by or on behalf of Seller to Buyer pursuant to this <u>Section 7.4.3</u> in the form provided by Seller (or excerpts thereof) until publication or presentation thereof (and thereafter subject to any applicable limitations placed on such re-publication or re-presentation by the publishing journal).

**ARTICLE 8**<br>**TERM**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**8.1 Term.** This Agreement shall commence on the Closing Date and shall continue in full force and effect until the earlier of (a) expiration of all obligations to make earn-out payments under <u>Section 5.2</u> with respect to the last Product in all countries in the Territory or (b) termination by either Party pursuant to <u>Section 8.2</u> (the "**Term**").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**8.2 Termination.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**8.2.1 Termination for Material Breach.** Either Party (the "**Non-Breaching Party**") may terminate this Agreement in its entirety in the event the other Party (the "**Breaching Party**") has materially breached this Agreement, and such material breach has not been cured within [\*\*\*] (or [\*\*\*] in the case of an undisputed failure to make any payment due and payable under this Agreement)] after receipt of written notice of such breach by the Breaching Party from the Non-Breaching Party (the "**Cure Period**"). The written notice describing the alleged material breach shall provide sufficient detail to put the Breaching Party on notice of such material breach. Any termination of this Agreement pursuant to this <u>Section 8.2.1</u> shall immediately become effective at the end of the Cure Period, unless the Breaching Party has cured such material breach prior to the expiration of such Cure Period, or, if such material breach is not susceptible to cure within the Cure Period, then the Non-Breaching Party's right of termination shall be suspended only if and for so long as the Breaching Party provides to the Non-Breaching Party a written plan during the Cure Period that is reasonably calculated to effect a cure of such material breach, such plan is accepted by the Non-Breaching Party (such acceptance not to be unreasonably withheld, conditioned, or delayed), and the Breaching Party commits to and carries out such plan. Notwithstanding the foregoing, if the Breaching Party in good faith disputes in writing during the Cure Period the existence or materiality of a breach described in the Non-Breaching Party's notice of material breach, then the Non-Breaching Party shall not have the right to terminate this Agreement pursuant to this <u>Section 8.2.1</u> unless and until such good faith dispute is finally determined under <u>Section 10.2</u> in the Non-Breaching Party's favor and the Breaching Party fails to cure such material breach within [\*\*\*] (or [\*\*\*] in the case of a failure to make any payment due or payable under this Agreement) thereafter.]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**8.2.2 Termination for Bankruptcy.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)** Either Party may terminate this Agreement in its entirety upon providing written notice to the other Party if such other Party makes a general assignment for the benefit of creditors, files an insolvency petition in bankruptcy, petitions for or acquiesces in the appointment of any receiver, trustee or similar officer to liquidate or conserve its business or any substantial part of its assets, commences under the laws of any jurisdiction any proceeding involving its insolvency, bankruptcy, reorganization, adjustment of debt, dissolution, liquidation or any other similar proceeding for the release of financially distressed debtors, or becomes a party to any proceeding or action of the type described above, and such proceeding or action remains un-dismissed or un-stayed for a period of more than sixty (60) days.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** All rights and licenses granted under or pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11 of the United States Code and other similar laws in any jurisdiction outside the United States (collectively, the "**Bankruptcy Laws**"),

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Exhibit 10.21

licenses of rights to "intellectual property" as defined under the Bankruptcy Laws. If a case is commenced during the Term by or against a Party under Bankruptcy Laws then, unless and until this Agreement is rejected as provided pursuant to such Bankruptcy Laws, such Party (in any capacity, including debtor-in-possession) and its successors and assigns (including a Title 11 trustee) shall perform all of the obligations in this Agreement intended to be performed by such Party. If a case is commenced during the Term by or against a Party under the Bankruptcy Laws, this Agreement is rejected as provided for under the Bankruptcy Laws, and the non-bankrupt Party elects to retain its rights hereunder as provided for under the Bankruptcy Laws, then the Party subject to such case under the Bankruptcy Laws (in any capacity, including debtor-in-possession) and its successors and assigns (including a Title 11 trustee), shall provide to the non-bankrupt Party copies of all patent, Know-How and information necessary for the non-bankrupt Party to prosecute, maintain and enjoy its rights under the terms of this Agreement; provided that, to the extent applicable, the non-bankrupt Party continues to fulfill its payment obligations under <u>Article 5</u> as specified herein in full. All rights, powers and remedies of the non-bankrupt Party as provided herein are in addition to and not in substitution for any and all other rights, powers and remedies now or hereafter existing at Law or in equity (including the Bankruptcy Laws) in the event of the commencement of a case by or against a Party under the Bankruptcy Laws. In particular, it is the intention and understanding of the Parties to this Agreement that the rights granted to the Parties under this <u>Section 8.2.2(b)</u> are essential to the Parties' respective businesses and the Parties acknowledge that damages are not an adequate remedy.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**8.2.3 Effects of Termination.** In the event of termination of this Agreement pursuant to <u>Section 8.2.1</u> or <u>8.2.2</u> by either Party:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)** All rights and licenses granted to Buyer herein with respect to the Program Molecules and Products shall terminate;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** At Seller's written request, Buyer shall assign to Seller the Acquired Assets and any Transaction IP Controlled by Seller that solely relates to, or was used by or on behalf of Buyer with respect to, the Program Molecules and Products; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(c)** At Seller's written request, Buyer shall transfer to Seller any and all regulatory materials (including Regulatory Materials), including any INDs, Regulatory Filings or Regulatory Approvals, that are needed to continue fully exploiting the Program Molecules and Products.

**ARTICLE 9**<br>**SURVIVAL; INDEMNIFICATION; INSURANCE; LIMITATIONS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.1 Survival of Representations, Warranties and Covenants.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.1.1 Seller Representations.** The representations and warranties of Seller set forth in this Agreement shall not survive the execution and delivery of this Agreement and shall terminate on the Effective Date, provided that the Fundamental Representations will survive for [\*\*\*]. Any breach of a Fundamental Representation in respect of which indemnification may be sought under this Agreement shall survive the time at which it would otherwise terminate pursuant to the preceding sentence until the final resolution of such Claim (as defined below) if, prior to such time, both a Claim Certificate (as defined below) with respect to such breach shall have been timely delivered pursuant to <u>Section 9.5</u> to Buyer and such Claim is pursued hereunder within a reasonable time period thereafter.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.1.2 Buyer Representations.** The representations and warranties of Buyer set forth in this Agreement shall survive the execution and delivery of this Agreement and the Closing Date and shall terminate at 11:59 PM Pacific Standard Time on the date that is [\*\*\*] after the Closing Date.

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Exhibit 10.21

Notwithstanding the preceding sentence, any breach of a representation or warranty in respect of which indemnification may be sought under this Agreement shall survive the time at which it would otherwise terminate pursuant to the preceding sentence until the final resolution of such Claim if, prior to such time, both a Claim Certificate with respect to such breach shall have been timely delivered pursuant to <u>Section 9.5</u> to Seller and such Claim is pursued hereunder within a reasonable time period thereafter.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.1.3 Covenants.** The respective covenants, agreements and obligations of Seller and Buyer set forth in this Agreement shall survive the execution and delivery of this Agreement and the Closing Date and shall terminate upon the earlier of (a) the expiration of the period explicitly set forth within such covenants, agreements and obligations (if any) and (b) expiration or earlier termination of this Agreement; provided that the rights and obligations of the Parties under <u>Article 7</u> will remain in effect after expiration or termination of this Agreement for the time period set forth therein. Notwithstanding the preceding sentence, any breach of covenants, agreements and obligations in respect of which indemnification may be sought under this Agreement shall survive the time at which it would otherwise terminate pursuant to the preceding sentence until the final resolution of such Claim, if, prior to such time, both a Claim Certificate with respect to such breach shall have been timely delivered pursuant to <u>Section 9.5</u> to the Party against whom such indemnification is sought and such Claim is pursued hereunder within a reasonable time period thereafter.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.2 Indemnification by Buyer.** Buyer agrees to defend Seller, its Affiliates and its (and its Affiliates') directors, officers, employees and agents (the "**Seller Indemnified Parties**") at Buyer's cost and expense, and will indemnify and hold Seller and the other Seller Indemnified Parties harmless from and against any claims, losses, costs, damages, Taxes (including penalties and interest), fees or expenses (including legal fees and expenses) (collectively, "**Losses**") resulting from any claims, actions or demands (collectively "**Claims**") arising out of or in connection with:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.2.1** the breach by Buyer of this Agreement or the Original Agreement, including (a) any of the representations or warranties made hereunder by Buyer or (b) the covenants and obligations made hereunder or thereunder by Buyer, including those related to the Assigned Agreements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.2.2** any Post-Closing Liabilities; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.2.3** the research, development, making, have made, use, sell, offer for sale, and import or otherwise exploitation of the Program or any Product by or on behalf of Buyer or its Affiliates or (sub)licensees on or after the Closing Date, but only to the extent such Claim is brought by a Third Party against any Seller Indemnified Party(ies).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.3** Indemnification by Seller. Seller agrees to defend Buyer, its Affiliates and its (and its Affiliates') directors, officers, employees and agents (the "**Buyer Indemnified Parties**" at Seller's cost and expense, and will indemnify and hold Buyer and the other Buyer Indemnified Parties harmless from and against any Losses resulting from any Claims arising out of or in connection with:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.3.1** the breach by Seller of any Fundamental Representations;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.3.2** any Excluded Liabilities; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.3.3** the research, development, making, have made, use, sell, offer for sale, and import or otherwise exploitation of the Program or any Product by or on behalf of Seller or its Affiliates prior to the Closing Date, but only to the extent such Claim is brought by a Third Party against any Buyer Indemnified Party(ies).

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Exhibit 10.21

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.4 Limitations.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.4.1 Deductible.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)** Subject to <u>Section 9.4.4</u>, no Claim may be made by Seller as the Indemnified Party for indemnification pursuant to <u>Section 9.2</u> for breach of any representation or warranty in <u>Section 6.2</u> until the aggregate amount of Losses for which a Seller seeks to be indemnified pursuant to <u>Section 9.2</u> exceeds [\*\*\*] (Seller's "**Deductible**"), at which time the Seller Indemnified Parties shall be entitled to indemnification for all such Losses in excess of Seller's Deductible.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** Subject to <u>Section 9.4.4</u>, no Claim may be made by Buyer as the Indemnified Party for indemnification pursuant to <u>Section 9.3</u> for breach of any Fundamental Representations until the aggregate amount of Losses for which a Buyer Indemnified Party seeks to be indemnified pursuant to <u>Section 9.3</u> exceeds [\*\*\*] (Buyer's "**Deductible**"), at which time the Buyer Indemnified Parties shall be entitled to indemnification for all such Losses in excess of the Buyer's Deductible.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.4.2 Caps.** Subject to <u>Section 9.4.4</u>, the cumulative indemnification of Seller under <u>Section 9.3.1</u> shall not exceed [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.4.3 Calculation.** Any Losses as to which indemnification provided for in <u>Section 9.2</u> or <u>Section 9.3</u> may apply shall be determined net of any cash recovery actually received by an Indemnified Party with respect to insurance or other Third-Party recovery proceeds specifically with respect to the specific matter for which indemnification is sought, less any current costs associated with obtaining such recovery. If an Indemnified Party receives an indemnification payment pursuant to this Agreement and later receives insurance proceeds or other Third-Party recovery proceeds in respect of the related Losses, then the Indemnified Party shall promptly remit to the Indemnifying Party, amounts equal to the lesser of (a) the amount of such insurance proceeds or other Third-Party recovery proceeds, if any, and (b) the amount of the indemnification payment previously paid by or on behalf of the Indemnifying Party with respect to such Losses; provided, however, that the Indemnified Party shall not be obligated to pay such insurance proceeds or other Third-Party recovery proceeds in the event that the Indemnified Party has additional Losses which would have been recovered had such amounts been available from the Indemnifying Party. This <u>Section 9.4.3</u> shall not imply and shall not be construed to imply any obligation on the part of any Person to seek or pursue any such recovery and the failure to seek or pursue any such recovery shall not be defense to any indemnification obligation hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.4.4 Certain Exceptions to Limitations.** Notwithstanding anything to the contrary in this Agreement, the limitations and thresholds and other provisions set forth in this <u>Article 9</u> shall not apply to Claims (a) involving fraud or (b) involving or related to any Sales Milestone Payments, Development Milestone Payments, earn-out payments or other payments payable by Buyer pursuant to this Agreement, and any Losses arising from or indemnification payments made on account of such Claims pursuant to this <u>Article 9</u> shall not be taken into account in determining the applicability of such limitations and thresholds and other provisions to other Losses or Claims.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.5 Procedures.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.5.1 General.** Promptly after the discovery by any Indemnified Party of any Loss or Losses, Claim or breach, including any Claim by a Third-Party (a "**Third-Party Claim**"), that would reasonably be expected to give rise to a Claim for indemnification hereunder, the Indemnified Party shall deliver to Seller or Buyer (the "**Indemnifying Party**"), a certificate (a "**Claim Certificate**") that:

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Exhibit 10.21

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(a)** states that the Indemnified Party has paid or properly accrued Losses, or reasonably anticipates that it may or will incur liability for Losses, for which such Indemnified Party may be entitled to indemnification pursuant to this Agreement; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(b)** specifies in reasonable detail, to the extent practicable and available, each individual item of Loss included in the amount so stated, the basis for any anticipated liability and the nature of the misrepresentation, default, breach of warranty or breach of covenant or Claim to which each such item is related and, to the extent computable, an estimation of the amount to which such Indemnified Party claims to be entitled hereunder;

*provided*, *that* no delay on the part of any Indemnified Party in notifying the Indemnifying Party, shall relieve the Indemnifying Party of any liability or obligations hereunder except to the extent that the Indemnifying Party has been actually prejudiced thereby, and then only to such extent.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.5.2 Objection.** If the Indemnifying Party objects to the indemnification of an Indemnified Party in respect of any Claim or Claims specified in any Claim Certificate, the Indemnifying Party shall deliver a written notice to such effect to the Indemnified Party within [\*\*\*] after the Indemnifying Party's receipt of such Claim Certificate. Thereafter, the Indemnifying Party and the Indemnified Party shall attempt in good faith to agree upon the rights of the respective parties for a period of not less than [\*\*\*] after receipt by the Indemnified Party of such written objection with respect to each of such Claims to which the Indemnifying Party has objected. If the Indemnified Party and the Indemnifying Party agree with respect to any of such Claims, the Indemnified Party and the Indemnifying Party together shall promptly prepare and sign a memorandum setting forth such agreement. Should the Indemnified Party and the Indemnifying Party fail to agree as to any particular item or items or amount or amounts within such [\*\*\*] period, then either party shall be entitled to pursue its available remedies for resolving its Claim for indemnification.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.5.3 Defense of Third-Party Claims.** The Indemnifying Party shall have the right to participate in, or by giving written notice to the Indemnified Party, to assume the defense of any Third-Party Claim at the Indemnifying Party's expense and by the Indemnifying Party's own legal counsel, and the Indemnified Party shall cooperate in good faith in such defense. In the event that the Indemnifying Party assumes the defense of any Third-Party Claim, subject to <u>Section 9.5.4</u>, it shall have the right to take such action as it deems necessary to avoid, dispute, defend, appeal or make counterclaims pertaining to any such Third-Party Claim in the name and on behalf of the Indemnified Party. The Indemnified Party shall have the right to participate in the defense of any Third-Party Claim with legal counsel selected by it, subject to the Indemnifying Party's right to control the defense thereof. The fees and disbursements of such legal counsel shall be at the expense of the Indemnified Party. If the Indemnifying Party elects not to defend such Third-Party Claim, fails to promptly notify the Indemnified Party in writing of its election to defend as provided in this Agreement, or fails to diligently prosecute the defense of such Third-Party Claim, the Indemnified Party may, subject to <u>Section 9.5.4</u>, defend such Third-Party Claim and seek indemnification for any and all Losses based upon, arising from or relating to such Third-Party Claim (subject to the limitations set forth herein). Seller and Buyer shall cooperate with each other in all reasonable respects in connection with the defense of any Third-Party Claim, including making available records relating to such Third-Party Claim and furnishing, without expense (other than reimbursement of actual out-of-pocket expenses) to the defending party, management employees of the non-defending party as may be reasonably necessary for the preparation of the defense of such Third-Party Claim.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.5.4 Settlement of Third-Party Claims.** Notwithstanding any other provision of this Agreement, the Indemnifying Party may enter into settlement of any Third-Party Claim without the prior written consent of the Indemnified Party, except that the consent of the Indemnified Party, which will not be unreasonably withheld or delayed, shall be required to enter into any settlement of any such Third-Party

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Exhibit 10.21

Claim that commits the applicable Indemnified Party to take, or to forbear to take, any action or does not provide for a full and complete written release by the applicable Third Party of any applicable Indemnified Party. If the Indemnified Party has assumed the defense pursuant to <u>Section 9.5.3</u>, it shall not agree to any settlement without the written consent of the Indemnifying Party (which consent shall not be unreasonably withheld, conditioned or delayed).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.5.5 Agreed Claims.** Claims for Losses specified in any Claim Certificate to which the Indemnifying Party did not object in writing within [\*\*\*] of receipt of such Claim Certificate, Claims covered by a memorandum of agreement of the nature described in <u>Section 9.5.2</u> and claims for Losses the validity and amount of which have been the subject of resolution by arbitration or of a final non-appealable judicial determination are hereinafter referred to, collectively, as "**Agreed Claims.**" The Indemnified Party shall be entitled to payment for any Agreed Claim within [\*\*\*] of the determination of the amount of any such Agreed Claims.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.6 Sole Remedy.** Other than rights and remedies provided in <u>Section 9.4.4</u> and <u>Section 10.12</u>, the sole and exclusive remedy for any breach or alleged breach of any representation, warranty or covenant of this Agreement shall be indemnification in accordance with this <u>Article 9</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.7** Insurance. Buyer will obtain and maintain insurance for so long as it is developing or commercializing any Product, and for a period of at least [\*\*\*], in an amount appropriate for its business and products of the type that are the subject of this Agreement and for its obligations under this Agreement. Specifically, Buyer will maintain (a) worker's compensation insurance with statutory limits in compliance with the worker's compensation laws of the state or states in which Buyer has employees in the United States (excluding Puerto Rico), (b) employer's liability coverage with a minimum limit of [\*\*\*] per occurrence; provided that Buyer has employees in the United States (excluding Puerto Rico), (c) clinical trial insurance with a minimum limit of [\*\*\*], and (d) general liability insurance with a minimum limit of [\*\*\*] per occurrence and [\*\*\*] in the aggregate, to be met by a combination of primary and excess limits. Beginning at least [\*\*\*] prior to the initiation of a clinical trial involving any Product, Buyer will obtain and maintain clinical trial insurance (either separately or as part of the general or product liability insurance). Beginning at least [\*\*\*] prior to the First Commercial Sale of a Product, Buyer will obtain and maintain product liability insurance of [\*\*\*]. Upon request, Buyer will provide Seller with evidence of the existence and maintenance of such insurance coverage. Buyer will notify Seller [\*\*\*] in advance of cancelation of any such insurance. All such insurances under this <u>Section 9.7</u> will be provided by a company or companies licensed to do business in United States having a financial rating of not less than A- Viii in the most current edition of Best's Key Rating Guide.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.8 LIMITATION OF DAMAGES.** IN NO EVENT SHALL EITHER PARTY BE LIABLE HEREUNDER TO THE OTHER PARTY FOR ANY PUNITIVE, RELIANCE, INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING LOST REVENUE, LOST PROFITS, OR LOST SAVINGS) HOWEVER CAUSED AND UNDER ANY THEORY, EVEN IF IT HAS NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. THE LIMITATIONS SET FORTH IN THIS <u>SECTION 9.8</u> SHALL NOT APPLY WITH RESPECT TO (A) ANY BREACH OF <u>ARTICLE 7</u> OR (B) THE WILLFUL MISCONDUCT, INTENTIONAL MISREPRESENTATION OR FRAUD OF A PARTY. NOTHING IN THIS <u>SECTION 9.8</u> IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF A PARTY UNDER THIS <u>ARTICLE 9</u> WITH RESPECT TO ANY DAMAGES PAID BY THE OTHER PARTY TO A THIRD PARTY IN CONNECTION WITH A THIRD-PARTY CLAIM.

**ARTICLE 10**<br>**MISCELLANEOUS**

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Exhibit 10.21

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.1 Entire Agreement; Amendment.** This Agreement (including all Schedules and Exhibits attached to this Agreement) and the Ancillary Agreements constitute the entire agreement between the Parties as to the subject matter hereof. Except as set forth in this <u>Section 10.1</u>, (a) all prior and contemporaneous negotiations, representations, warranties, agreements, statements, promises and understandings with respect to the subject matter of this Agreement are hereby superseded and merged into, extinguished by and completely expressed by this Agreement and (b) neither Party shall be bound by or charged with any written or oral agreements, representations, warranties, statements, promises or understandings not specifically set forth in this Agreement. No amendment, supplement or other modification to any provision of this Agreement shall be binding unless in writing and signed by both Parties. Notwithstanding the foregoing, (i) all rights and obligations of the Parties that arose under the CDA during the period commencing on the CDA Effective Date and continuing through the Closing Date, including any dispute or alleged breach by a Party of any of the terms of the CDA during such period, shall be governed solely by the terms of the CDA, (ii) the terms and conditions of the CDA shall survive solely for the limited purposes set forth in subsection (i) above and (iii) the CDA shall otherwise terminate as of the Closing Date. For the avoidance of doubt, upon the execution of this Agreement, all provisions of the Original Agreement with respect to the Program Molecules or the Products are hereby superseded in their entirety and replaced herein and shall have no further force or effect.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.2 Governing Law; Jurisdiction.** This Agreement and its effect are subject to and shall be construed and enforced in accordance with the law of the State of New York, without regard to its conflicts of laws that would require the application of any other Law. Each of the Parties hereby irrevocably and unconditionally consents to submit to the exclusive jurisdiction of the federal courts located in the Southern District of the State of New York for any matter arising out of or relating to this Agreement and the transactions contemplated hereby, and agrees not to commence any litigation relating thereto except in such courts. Each of the Parties hereby irrevocably and unconditionally waives any objection to the laying of venue of any matter arising out of this Agreement or the transactions contemplated hereby in the courts of the State of New York and hereby further irrevocably and unconditionally waives and agrees not to plead or claim in any such court that any such matter brought in any such court has been brought in an inconvenient forum. The Parties agree that a final judgment in any such matter shall be conclusive and may be enforced in other jurisdictions by suits on the judgment or in any other manner provided by law. Any proceeding brought by either Party under this Agreement shall be exclusively conducted in the English language.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.3 Waiver of Jury Trial.** To the fullest extent permitted by Law, each of the Parties irrevocably waives all right to trial by jury in any Litigation arising out of or relating to this Agreement or any of the transactions contemplated by this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.4 Notice.** All notices or communication required or permitted to be given by either Party hereunder shall be deemed sufficiently given (a) three (3) Business Days after being sent by registered or certified mail, return receipt requested, postage prepaid, (b) one (1) Business Day after being sent for next Business Day delivery, fees prepaid, via a reputable nationwide overnight courier service or (c) on the date of confirmation of receipt (or the first Business Day following such receipt if the date of such receipt is not a Business Day) of transmission by email, in each case to the intended recipient as set forth below:

If to Buyer: Calithera Biosciences, Inc.

343 Oyster Point Blvd, Suite 200

South San Francisco, CA 94080

Attn: [\*\*\*]

[\*\*\*]

[\*\*\*]

------

Exhibit 10.21

If to Seller: Millennium Pharmaceuticals, Inc.

40 Landsdowne Street

Cambridge, MA 02139

United States

Attn: [\*\*\*]

[\*\*\*]

Either Party may change the address to which notices and other communication hereunder are to be delivered by giving the other Party notice in the manner herein set forth.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.5 Compliance with Law; Severability.** Nothing in this Agreement shall be construed to require the commission of any act contrary to Law. If any one or more provisions of this Agreement is held to be invalid, illegal or unenforceable, the affected provisions of this Agreement shall be curtailed and limited only to the extent necessary to bring it within the applicable legal requirements and the validity, legality and enforceability of the remaining provisions of this Agreement shall not in any way be affected or impaired thereby.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.6 Successors and Assigns.** This Agreement shall bind and inure to the benefit of the successors and permitted assigns of the Parties hereto. Neither this Agreement nor any right, interest or obligation of a Party hereunder may be assigned by either Party without the written consent of the other Party, except that each Party may assign this Agreement and the rights, obligations and interests of such Party under this Agreement (a) in whole or in part, to any of its Affiliates, or (b) in whole, but not in part, in the event of a Change of Control of a Party; provided, that, (i) the assigning Party will provide the other Party with prompt written notice of assignment, (ii) the permitted assignee will assume all obligations of its assignor under this Agreement (or as related to the assigned part where a partial assignment to an Affiliate), (iii) unless expressly so agreed in writing by the Parties, no permitted assignment will relieve the assignor of liability under this Agreement, and (iv) any attempted assignment in contravention of this <u>Section 10.6</u> shall be void.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.7 Waivers.** A Party's consent to or waiver, express or implied, of the other Party's breach of its obligations hereunder shall not be deemed to be or construed as a consent to or waiver of any other breach of the same or any other obligations of such breaching Party. A Party's failure to complain of any act, or failure to act, by the other Party, to declare the other Party in default, to insist upon the strict performance of any obligation or condition of this Agreement or to exercise any right or remedy consequent upon a breach thereof, no matter how long such failure continues, shall not constitute a waiver by such Party of its rights hereunder, of any such breach, or of any other obligation or condition. A Party's consent in any one instance shall not limit or waive the necessity to obtain such Party's consent in any future instance and in any event no consent or waiver shall be effective for any purpose hereunder unless such consent or waiver is in writing and signed by the Party granting such consent or waiver.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.8 Force Majeure.** Except for the obligation to pay money when due, neither Party shall be liable to the other for failure or delay in the performance of any of its obligations under this Agreement for the time and to the extent such failure or delay is caused by a Force Majeure. The Party affected by the Force Majeure shall provide the other Party in writing with full particulars thereof as soon as it becomes aware of the same (including its best estimate of the likely extent and duration of the interference with its activities), and will use commercially reasonable efforts to overcome the difficulties created thereby and to resume performance of its obligations as soon as practicable. For the avoidance of doubt, under no circumstances shall the alleged or actual inability to pay money be considered an event of Force Majeure.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.9 No Third Party Beneficiaries.** Nothing in this Agreement shall be construed as giving any Person, other than the Parties hereto and their successors and permitted assigns, any right, remedy or claim

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Exhibit 10.21

under or in respect of this Agreement or any provision hereof, except for the provisions of <u>Article 9</u> (with respect to which the Persons to which <u>Article 9</u> applies shall be Third Party beneficiaries in accordance with <u>Article 9</u>).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.10 Headings; Schedules and Exhibits.** Article and Section headings used herein are for convenient reference only, and are not a part of this Agreement. All Schedules and Exhibits are incorporated herein by this reference.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.11 Counterparts.** This Agreement may be executed in counterparts by a single Party, each of which when taken together shall constitute one and the same agreement. Counterparts may be delivered via facsimile, electronic mail (including .pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, Uniform Electronic Transactions Act or other applicable law) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.12 Specific Performance.** The Parties agree that irreparable damage could occur if any provision of <u>Article 7</u> of this Agreement were not performed in accordance with the terms thereof and that the Parties shall be entitled to seek specific performance of the terms of <u>Article 7</u>, without the necessity of posting a bond or other security or proving the inadequacy of damages as a remedy, in addition to any other remedy to which they are entitled at law or in equity.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.13 Further Assurances.** From time to time after the Closing Date, and for no further consideration (except as expressly set forth in <u>Section 5.2</u>, <u>Section 5.3</u> and <u>Section 5.4</u>), each Party shall execute, acknowledge and deliver such assignments, transfers, consents, assumptions and other documents and instruments and take such other actions as may be necessary or desirable to consummate and make effective the transactions contemplated by this Agreement.

*(Signature Pages Immediately to Follow)*

**IN WITNESS WHEREOF**, this Agreement has been executed by the Parties hereto as of the Effective Date.

**BUYER:**

**Calithera Biosciences, Inc.**

By:

Name: Stephanie Wong

Title: Chief Financial Officer

**SELLER:**

**Millennium Pharmaceuticals, Inc.**

By:

Name: Michael Martin

Title: Authorized Signatory

------

Exhibit 10.21

**IN WITNESS WHEREOF**, this Agreement has been executed by the Parties hereto as of the Effective Date.

**BUYER:**

**Calithera Biosciences, Inc.**

By:

Name: Stephanie Wong

Title: Chief Financial Officer

**SELLER:**

**Millennium Pharmaceuticals, Inc.**

By:

Name: Michael Martin

Title: Authorized Signatory

------

Exhibit 10.21

**<u>Schedule 1.1(a)</u>**

**<u>TAK-228 Structure</u>**

[\*\*\*]

------

Exhibit 10.21

**<u>Schedule 1.1(b)</u>**

**<u>[\*\*\*] Structure</u>**

------

Exhibit 10.21

**<u>Schedule 1.1(c)</u>**

**<u>Materials</u>**

[\*\*\*]

------

Exhibit 10.21

**<u>Schedule 1.1(d)</u>**

**<u>Regulatory Materials</u>**

[\*\*\*]

------

Exhibit 10.21

**<u>Schedule 1.1(e)</u>**

**<u>Existing inventory Transferred/Assigned</u>**

[\*\*\*]

------

Exhibit 10.21

**<u>Schedule 1.1(f)</u>**

**<u>Assigned Agreements</u>**

[\*\*\*]

------

Exhibit 10.21

**<u>Schedule 1.1(g)</u>**

**<u>Assigned Know-How</u>**

[\*\*\*]

------

Exhibit 10.21

**<u>Schedule 1.1(h) – Part 1</u>**

**<u>Assigned Patent Rights</u>**

[\*\*\*]

------

Exhibit 10.21

**<u>Schedule 1.1(h) – Part 2</u>**

**<u>In-Licensed Patent Rights</u>**

[\*\*\*]

------

Exhibit 10.21

**<u>Schedule 1.1(f)</u>**

**<u>Initial Development Plan</u>**

[\*\*\*]

------

Exhibit 10.21

**<u>Schedule 2.3</u>**

**<u>Acquired Assets</u>**

[\*\*\*]

------

Exhibit 10.21

**<u>Schedule 2.4</u>**

**<u>Select List of Excluded Assets</u>**

[\*\*\*]

------

Exhibit 10.21

**<u>Schedule 2.6</u>**

**<u>Licensed Intellectual Property</u>**

[\*\*\*]

------

Exhibit 10.21

**<u>Schedule 3.6</u>**

**<u>Related Agreements</u>**

[\*\*\*]

------

Exhibit 10.21

**<u>Schedule 3.9</u>**

**<u>Delayed Assigned Contract</u>**

[\*\*\*]

[\*\*\*]

------

Exhibit 10.21

**<u>Schedule 5.9</u>**

**<u>Seller's Bank Account</u>**

[\*\*\*]

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Exhibit 10.21

**<u>Exhibit A</u>**

**<u>Bill of Sale</u>**

(*See Attached*)

------

Exhibit 10.21

**<u>BILL OF SALE</u>**

This BILL OF SALE (this "**Agreement**") is made and entered into as of October 18, 2021, between Millennium Pharmaceuticals, Inc., a Delaware corporation ("**Seller**"), and Calithera Biosciences, Inc., a Delaware corporation, ("Buyer"). Capitalized terms used but not defined in this Agreement shall have the respective meanings set forth in the Purchase Agreement (as defined below).

**WHEREAS**, Seller and Buyer entered into that certain Asset Purchase Agreement, dated October 18, 2021 (the "**Purchase Agreement**"), which contemplates the sale by Seller to Buyer of the Acquired Assets; and

**WHEREAS**, in connection with the consummation of the transactions contemplated by the Purchase Agreement, Seller desires to assign its rights and obligations under the Acquired Assets to Buyer, and Buyer desires to accept such assignment and assume the obligations of Buyer under the Acquired Assets.

**NOW, THEREFORE**, in consideration of the premises and the mutual covenants, representations and warranties herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby mutually acknowledged, the Parties hereby agree as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1. In accordance with the terms and subject to the conditions set forth in the Purchase Agreement (including Section 2.2.1 thereof), effective as of the Closing, the Seller hereby sells, conveys, transfers, assigns and delivers to, and hereby causes its Affiliates to sell, convey, assign, transfer and deliver to, Buyer all right, title, and interest, legal and equitable, of Seller and its Affiliates in and to all of the Acquired Assets, free and clear of any Encumbrance.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2. In accordance with the terms and subject to the conditions set forth in the Purchase Agreement (including Section 2.2.2 thereof), effective as of the Closing, the Buyer hereby accepts all right, title and interest, legal and equitable, in and to all of the Acquired Assets.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3. With regard to any Delayed Assigned Contract, the assignment of such Delayed Assigned Contract shall be effective as of the relevant Assignment Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4. This Agreement is being executed and delivered pursuant to, and is subject to and shall be governed by the terms and conditions of, the Purchase Agreement. Nothing in this Agreement is intended to or shall be deemed to amend, modify, supplement, or limit in any manner any of the representations, warranties, covenants, agreements, rights, or obligations of Seller and Buyer under the Purchase Agreement. In the event of any conflict between the terms and conditions of this Agreement and the terms and conditions of the Purchase Agreement, the terms and conditions of the Purchase Agreement shall control. This Agreement, the Purchase Agreement and the other Ancillary Agreements constitute the entire agreement between the Parties with respect to the subject matter hereof and thereof and supersede all prior agreements and understandings, both oral and written, between the Parties with respect to the subject matter hereof and thereof.

------

Exhibit 10.21

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5. Any notice or other communication required or permitted under this Agreement shall be in writing and deemed to have been duly given if made in accordance with Section 10.4 (Notice) of the Purchase Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6. This Agreement shall bind and inure to the benefit of the successors and permitted assigns of the Parties; provided, that this Agreement may only be assigned in connection with a permissible assignment of the Purchase Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7. This Agreement hereby incorporates the provisions of Sections 10.2 (Governing Law; Jurisdiction) and 10.3 (Waiver of Jury Trial) of the Purchase Agreement, each of which shall apply to this Agreement as if fully set forth herein, mutatis mutandis.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8. Neither Party shall be bound by or charged with any written or oral agreements, representations, warranties, statements, promises or understandings not specifically set forth in this Agreement or the Purchase Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9. No amendment, supplement or other modification to any provision of this Agreement shall be binding unless in writing and signed by both Parties. A Party's consent to or waiver, express or implied, of the other Party's breach of its obligations hereunder shall not be deemed to be or construed as a consent to or waiver of any other breach of the same or any other obligations of such breaching Party. A Party's failure to complain of any act, or failure to act, by the other Party, to declare the other Party in default, to insist upon the strict performance of any obligation or condition of this Agreement or to exercise any right or remedy consequent upon a breach thereof, no matter how long such failure continues, shall not constitute a waiver by such Party of its rights hereunder, of any such breach, or of any other obligation or condition.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10. If any one or more provisions of this Agreement is held to be invalid, illegal or unenforceable, the affected provisions of this Agreement shall be curtailed and limited only to the extent necessary to bring it within the applicable legal requirements and the validity, legality and enforceability of the remaining provisions of this Agreement shall not in any way be affected or impaired thereby.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11. From time to time after the date of this Agreement, each Party shall execute, acknowledge and deliver such assignments, transfers, consents, assumptions and other documents and instruments and take such other actions as may be necessary or desirable to consummate and make effective the transactions contemplated by this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12. This Agreement may be executed in counterparts by a single Party, each of which when taken together shall constitute one and the same agreement. Counterparts may be delivered via facsimile, electronic mail (including .pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, Uniform Electronic Transactions Act or other applicable law) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.

*[SIGNATURE PAGE FOLLOWS]*

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Exhibit 10.21

IN WITNESS WHEREOF, the parties have caused this Agreement to be executed and delivered as of the date first written above.

MILLENIUM PHARMACEUTICALS, INC.

By: <u>/s/ Nenad Grmusa</u> 

Name: Nenad Grmusa

Title: Head, Center for External Innovation

CALITHERA BIOSCIENCES, INC.

By:

Name:

Title:

IN WITNESS WHEREOF, the parties have caused this Agreement to be executed and delivered as of the date first written above.

MILLENIUM PHARMACEUTICALS, INC.

By:

Name: Nenad Grmusa

Title: Head, Center for External Innovation

CALITHERA BIOSCIENCES, INC.

By: <u>/s/ Susan M. Molineaux</u> 

Name: Susan M. Molineaux, Ph.D.

Title: President and Chief Executive Officer

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Exhibit 10.21

**<u>Exhibit B</u>**

**<u>Patent Assignment Agreement</u>**

(*See Attached*)

------

Exhibit 10.21

**<u>PATENT ASSIGNMENT AGREEMENT</u>**

This PATENT ASSIGNMENT AGREEMENT (this "**Agreement**") is made and entered into as of October 18, 2021, between Takeda Pharmaceutical Company Limited, a company incorporated under the laws of Japan ("**Takeda**") and the parent of Millennium Pharmaceuticals, Inc. ("**Seller**"), and Calithera Biosciences, Inc., a Delaware corporation. ("**Buyer**"). Capitalized terms used but not defined in this Agreement shall have the respective meanings set forth in the Purchase Agreement (as defined below).

**WHEREAS**, Seller and Buyer entered into that certain Asset Purchase Agreement, dated October 18, 2021 (the "**Purchase Agreement**"), pursuant to which, among other things, Seller has agreed to enter into this Agreement (or to cause its Affiliate to enter into this Agreement) in order to assign to Buyer, Seller's and its Affiliates' right, title and interest to the Transferred Patent Rights (as defined below).

**WHEREAS**, in connection with the consummation of the transactions contemplated by the Purchase Agreement, Takeda, on behalf of itself and Seller, desires to assign its and its Affiliates' right, title and interest to the Transferred Patent Rights (as defined below) to Buyer, and Buyer desires to accept such assignment and assume the obligations of Buyer under the Transferred Patent Rights (as defined below).

**NOW, THEREFORE**, in consideration of the premises and the mutual covenants, representations and warranties herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby mutually acknowledged, the Parties hereby agree as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1. In accordance with the terms and subject to the conditions set forth in the. Purchase Agreement (including Sections 2.2.1(c) and 2.2.2(b) thereof), effective as of the Closing, Takeda on behalf of itself and Seller hereby sells, assigns, transfers, conveys and delivers to, and hereby causes its Affiliates to sell, convey, assign, transfer and deliver to, Buyer all of Takeda's and its Affiliates' (including Seller's) right, title and interest in and to those Patent Rights listed on Schedule 1 hereto, including the right to claim priority from the same in the United States and all foreign counties, and to claim the priority from the same as provided by the Paris Convention, together in each case with all registrations, applications therefor, patents (as applicable) issuing from any applications therefor, and renewals and extensions of the foregoing in the United States and for all foreign countries that are or may be secured under the laws of the United States and all foreign countries, including any division, renewal, continuation in whole or in part, substitution, conversion, reissue, reexamination, prolongation or extension thereof, now or hereafter in effect, for Buyer's own use and enjoyment as fully and entirely as the same would have been held and enjoyed by Takeda, Seller or any of their Affiliates if this assignment and sale had not been made, together with all income, royalties or payments due or payable as of the date of this Agreement or thereafter, including all claims for damages by reason of past, present or future infringement, misappropriation or other unauthorized use of such patents with the right to sue for and collect the same for Buyer's own use and enjoyment (collectively, the "**Transferred Patent Rights**"). Takeda on behalf of itself and its Affiliates hereby waives and agrees not to enforce any rights of attribution and integrity and other moral rights Takeda or any of its Affiliates may have in the Transferred Patent Rights.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2. Takeda on behalf of itself and its Affiliates hereby authorizes and requests the United States Commissioner of Patents and Trademarks and any other applicable government authority to record Buyer as the buyer and owner of the Transferred Patent Rights, and issue any and all registrations thereon to Buyer, as buyer of Seller's and its Affiliates' right, title and interest in, to and under the same, for the sole use and enjoyment of Buyer.

------

Exhibit 10.21

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3. Following the date hereof, upon Buyer's reasonable request, and at Buyer's cost and expense, Takeda shall, and shall cause its Affiliates to, take such reasonable steps and actions, and provide such reasonable cooperation and assistance to Buyer and its successors, assigns, and legal representatives, including the execution and delivery of any affidavits, declarations, oaths, exhibits, assignments, or other documents, as may be reasonably necessary to effect, evidence or perfect the assignment of the Transferred Patent Rights to Buyer or any assignee or successor thereto.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4. This Agreement is being executed and delivered pursuant to, and is subject to and shall be governed by the terms and conditions of, the Purchase Agreement. Nothing in this Agreement is intended to or shall be deemed to amend, modify, supplement, or limit in any manner any of the representations, warranties, covenants, agreements, rights, or obligations of Seller and Buyer under the Purchase Agreement. In the event of any conflict between the terms and conditions of this Agreement and the. terms and conditions of the Purchase Agreement, the terms and conditions of the Purchase Agreement shall control. This Agreement, the Purchase Agreement and the other Ancillary Agreements constitute the entire agreement between the parties hereto or thereto with respect to the subject matter hereof or thereof and supersede all prior agreements and understandings, both oral and written, between the parties hereto or thereto with respect to the subject matter hereof or thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5. Any notice or other communication required or permitted under this Agreement shall be in writing and deemed to have been duly given if made in accordance with Section 10.4 (Notice) of the Purchase Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6. This Agreement shall bind and inure to the benefit of the successors and permitted assigns of the parties hereto; provided, that this Agreement may only be assigned in connection with a permissible assignment of the Purchase Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7. This Agreement hereby incorporates the provisions of Sections 10.2 (Governing Law; Jurisdiction) and 103 (Waiver of Jury Trial) of the Purchase Agreement, each of which shall apply to this Agreement as if fully set forth herein, mutatis mutandis.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8. Neither Party shall be bound by or charged with any written or oral agreements, representations, warranties, statements, promises or understandings not specifically set forth in this Agreement or in the Purchase Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9. No amendment, supplement or other modification to any provision of this Agreement shall be binding unless in writing and signed by both parties. A party's consent to or waiver, express or implied, of the other party's breach of its obligations hereunder shall not he deemed to be or construed as a consent to or waiver of any other breach of the same or any other obligations of such breaching party. A party's failure to complain of any act, or failure to act, by the other party, to declare the other Party in default, to insist upon the strict performance of any obligation or condition of this Agreement or to exercise any right or remedy consequent upon a breach thereof, no matter how long such failure continues, shall not constitute a waiver by such party of its rights hereunder, of any such breach, or of any other obligation or condition.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10. If any one or more provisions of this Agreement is held to be invalid, illegal or unenforceable, the affected provisions of this Agreement shall be curtailed and limited only to the extent necessary to bring it within the applicable legal requirements and the validity, legality and enforceability of the remaining provisions of this Agreement shall not in any way be affected or impaired thereby.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11. From time to time after the date of this Agreement, each party (and Seller or its Affiliates, as applicable) shall execute, acknowledge and deliver such assignments, transfers, consents, assumptions

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Exhibit 10.21

and other documents and instruments and take such other actions as may be necessary or desirable to consummate and make effective the transactions contemplated hy this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12. This Agreement may be executed in counterparts by a single party, each of which when taken together shall constitute one and the same agreement. Counterparts may be delivered via facsimile, electronic mail (including .pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, Uniform Electronic Transactions Act or other applicable law) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.

[SIGNATURE PAGE FOLLOWS)

------

Exhibit 10.21

IN WITNESS WHEREOF, the undersigned have executed this Patent Assignment Agreement as of the date first set forth above.

TAKEDA PHARMACEUTICAL COMPANY LIMITED

By: *<u>/s/ Masanori Sato</u>* 

Name: Masanori Sato

Title: Head, Center for External Innovation Japan/APAC

CALITHERA BIOSCIENCES, INC.

By: *<u>/s/ Susan M. Molineaux</u>* 

Name: Susan M. Molineaux, Ph.D.

Title: President and Chief Executive Officer

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Exhibit 10.21

**<u>Schedule 1</u>**

**Transferred Patent Rights**

[\*\*\*]

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Exhibit 10.21

**<u>Exhibit C</u>**

**<u>Press Release</u>**

**Calithera Expands Oncology Pipeline with Acquisition of Two Clinical-Stage Assets from Takeda Pharmaceuticals**

*- TORC 1/2 inhibitor sapanisertib and SYK inhibitor mivavotinib strengthen Company's <br>precision oncology pipeline*

*- Calithera will initiate Phase 2 clinical trials of sapanisertib and mivavotinib in 2022*

*- Calithera to host webcast and conference call today at 5:30 p.m. ET / 2:30 p.m. PT*

**SOUTH SAN FRANCISCO, Calif., October 18, 2021** (GLOBE NEWSWIRE) – Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision oncology biopharmaceutical company, today announced an agreement with Takeda Pharmaceutical Company Limited ("Takeda") to acquire two clinical-stage compounds, both of which have demonstrated single-agent clinical activity with the greatest potential in biomarker-defined cancer-patient populations. The compounds, sapanisertib (CB-228, formerly TAK-228) and mivavotinib (CB-659, formerly TAK-659), further strengthen Calithera's pipeline of clinical-stage targeted therapies.

"We believe that these clinical-stage compounds are an excellent complement to our, internally-developed pipeline programs, and fit well with our current strategic focus on biomarker-driven therapeutic approaches. We are encouraged by the promising single-agent clinical data that suggest these investigational therapies could help to transform treatment for multiple cancer patient populations with high unmet need," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "Specifically, sapanisertib has the potential to be the first targeted treatment for patients with NRF2-mutated squamous non-small cell lung cancer. We have learned a great deal about the unmet medical need of patients with KEAP1/NRF2 mutations, as well as how to identify and recruit these patients during the conduct of our KEAPSAKE trial, evaluating telaglenastat. This complementary approach in KEAP1/NRF2-mutant squamous NSCLC demonstrates our commitment to these patients and the pathway.

"Additionally, mivavotinib has the potential to be a best-in-class SYK inhibitor in non-Hodgkin's lymphoma, as well as a first-to-market approach for patients with diffuse large B-cell lymphoma whose tumors harbor MyD88 and/or CD79 mutations."

------

Exhibit 10.21

"We plan to star a clinical trial in squamous NSCLC with sapanisertib and a clinical trial n DLBCL with mivavotinib, both in biomarker specific populations, and generate data in the next 12 tc 18 months that will define the clinical development and potential regulatory approval paths for both of these compounds."

The terms of the transaction include a total upfront cash payment to Takeda of $10 million and $35 million issued to Takeda in Calithera Series A preferred stock. Additionally, Takeda will to eligible to receive from Calithera clinical development, regulatory and sales milestone payments across both programs. Calithera will pay tiered royalties of high single-digits to low teens on future net sales should these candidates achieve regulatory approvals and subsequent commercial availability.

"Collaboration is an important aspect of our R&D strategy and at the center of our efforts to deliver new treatment options to patients. We are confident that Calithera, with their highly capable and experienced team, is the ideal partner to resume the development of sapanisertib and mivavotinib, and to maximize their potential to address underserved patient populations," said Christopher Arendt, Ph.D., head of Oncology Cell Therapy and Therapeutic Area Unit of Takeda. "We look forward to seeing how these programs advance under Calithera's leadership."

Sapanisertib is a dual TORC 1/2 inhibitor that targets a key survival mechanism in KEAP1/NRF2-mutated tumor cells. These mutations are found in a considerable sub-population of patients across multiple solid tumor types. Sapanisertib has demonstrated promising single-agent activity in patients with relapsed/refractory NRF2-mutated squamous non-small cell lung cancer (NSCLC) and exhibits differential anti-tumor activity compared to rapalog inhibitors of TORC1 in NRF2-mutan: squamous NSCLC *in vivo* models. A Phase 2 study planned to begin in the first quarter of 2022 will further evaluate sapanisertib as a monotherapy in patients with squamous NSCLC harboring a NRF2 mutation.

Mivavotinib is a SYK inhibitor that targets the constitutively active BCR pathway in many non-Hodgkin's lymphoma (NHL) cases as well as the constitutively active inflammatory signaling pathway in MyD88 mutated NHL. In early phase studies, mivavotinib showed promising single-agent responses in relapsed/refractory diffuse large B cell lymphoma (OLBCL). In addition, recent preclinical studies have shown enhanced SYK activity and sensitivity to SYK inhibition in DLBCL and other NHLs harboring mutations in MyD88 and/or CD79, which comprise a distinct genetic subset of DLBCL known to have poor outcomes with standard-of-care therapy. Accordingly, Calithera plans to initiate a Phase 2 study of mivavotinib in 2022 for the treatment of patients with DLBCL with and without mutations in MyD88 and CD79. Beyond DLBCL, both preclinical and clinical data support expansion across additional NHL subtypes and other hematologic malignancies as part of long-term plans.

------

Exhibit 10.21

More information about sapanisertib and mivavotinib can be found at calithera.com/pipeline.

**Webcast and Conference Call Information**

Calithera will hold a webcast today, Monday, October 18 at 5:30 p.m. Eastern Time / 2:30 p.m. Pacific Time. To access the link to the webcast, which will be broadcast live in listen-only mode, or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. Alternatively, the call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and referring to conference ID 6946687. The webcast will be recorded and available for replay on Calithera's website for 30 days.

**About Calithera**

Calithera Biosciences is a clinical-stage, precision oncology biopharmaceutical company developing targeted therapies to redefine treatment for biomarker-specific patient populations. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a robust pipeline of investigational, small molecule oncology compounds with a biomarker-driven approach that targets genetic vulnerabilities in cancer cells to deliver new therapies for patients suffering from aggressive hematologic and solid tumor cancers for which there are currently limited treatment options.

Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit www.calithera.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. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," "poised" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to Calithera's clinical trials, the timing and enrollment of the KEAPSAKE, sapanisertib Phase 2 and mivavotinib Phase 2 trials, the payment of future royalties, development, regulatory and sales milestone payments to Takeda, the potential impact and commercialization of sapanisertib for patients with NSCLC and a NRF2/KEAP1 mutation, the potential impact and commercialization of mivavotinib in patients with NEIL with and without mutations in MyD88 and CD79. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed

------

Exhibit 10.21

in this press release. Such product candidates may not be beneficial to patient or be successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera's stock price. Additional information concerning these and other risk factors affecting Calithera's business can be found in Calithera's periodic filings with the Securities and Exchange Commission at .vww.sec.gov. These forward-looking statements are lot guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

**CONTACTS:**

Stephanie Wong<br>Chief Financial Officer<br>(650) 870-1063<br>ir@Calithera.com

**Media**

Sam Brown, Inc.<br>Audra Friis<br>(917) 519-9577<br>audrafriis@sambrown.com

**Investors**

Burns McClellan<br>Lee Roth<br>212.213.0006<br>Iroth@burnsmc.com

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Exhibit 10.21

**<u>Exhibit D</u>**

**<u>Disclosure Schedules</u>**

[\*\*\*]

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Exhibit 10.21

**<u>Exhibit E</u>**

**<u>Memorandum of Understanding</u>**

(*See Attached*)

[\*\*\*]

------

## Exhibit 10.22

Exhibit 10.22

*CERTAIN INFORMATION HAS BEEN EXCLUDED FROM THIS AGREEMENT (INDICATED BY "[\*\*\*]") BECAUSE SUCH INFORMATION IS BOTH (A) NOT MATERIAL AND (B) THE TYPE THAT THE REGISTRANT CUSTOMARILY AND ACTUALLY TREATS AS PRIVATE OR CONFIDENTIAL.*

Confidential

EXECUTION VERSION

May 15, 2023

Millennium Pharmaceuticals, Inc.

40 Landsdowne Street <br>Cambridge, MA 02139 <br>United States

Re: Combination Product under Amended and Restated TAK-228 Asset Purchase Agreement dated May 15, 2023 between Millennium Pharmaceuticals, Inc. ("**Takeda**") and Calithera Biosciences, Inc. ("**Calithera**") ("**TAK-228 APA**") and License Agreement dated March 18, 2019 between Takeda Pharmaceutical Company Limited and Faeth Therapeutics, Inc. ("**Faeth**") (as successor in interest to Petra Pharma Corporation and Ravenna Pharmaceuticals, Inc.) ("**TAK-117 License Agreement**")

Dear Sir/Madam:

This letter agreement ("**Letter Agreement**") is being entered into in connection with the execution of the assignment and assumption of the rights and certain obligations of Calithera under the TAK-228 APA to Faeth as of the date of this Letter Agreement (the "**Assignment**"). Any capitalized terms not defined here shall be as defined in the TAK-228 APA or TAK-117 License Agreement, as applicable.

Upon consummation of the Assignment, Faeth will have rights and obligations under both the TAK-228 APA and TAK-117 License Agreement. In consideration of the mutual promises set forth herein, Takeda and Faeth (each a "**Party**" and collectively, "**Parties**") have agreed as follows solely with respect to a Combination Product under (and as defined in) the TAK-228 APA that includes a Program Molecule under TAK-228 APA and the Licensed Compound under the TAK-117 License Agreement (a "**228+117 Combination Product**"). For clarity, and notwithstanding anything in the TAK-228 APA or TAK-117 License Agreement to the contrary, a 228+117 Combination Product shall be a Product under the TAK-228 APA and under the TAK-117 License Agreement.

------

1. <u>228+117 [\*\*\*] Milestone Payments.</u> Notwithstanding the milestones set forth in [\*\*\*], [\*\*\*], the following development milestone events set forth in the table below (each a "[**\*\*\***] **Milestone Event**") shall apply in lieu of [\*\*\*]. Following the first achievement of each [\*\*\*] Milestone Event with respect to the first Product to achieve such [\*\*\*] Milestone Event, Faeth shall pay, or cause to be paid, to Takeda a one-time, non-refundable and non-creditable corresponding milestone payment (each, a "[**\*\*\***] **Milestone Payment**") within [\*\*\*]. Faeth shall notify Takeda within [\*\*\*] after each [\*\*\*] Milestone Event is first achieved. For the avoidance of doubt, each [\*\*\*] Milestone Payment shall be payable one (1) time upon the first achievement of the corresponding [\*\*\*] Milestone Event with respect to an applicable Product, regardless of the number of times such [\*\*\*] Milestone Event may be achieved by the same or different Products. [\*\*\*] For purposes of the foregoing, "Indication" shall have the meaning set forth in the TAK-228 APA.

---

| | | | |
|:---|:---|:---|:---|
| &nbsp;&nbsp;**[\*\*\*] Milestone Event** | **[\*\*\*] Milestone Payments** | **[\*\*\*] Milestone Payments** | **[\*\*\*] Milestone Payments** |
|  | &nbsp;&nbsp;**[\*\*\*]** | &nbsp;&nbsp;**[\*\*\*]** | &nbsp;&nbsp;**[\*\*\*]** |
| &nbsp;&nbsp;[\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | |
|:---|:---|
| &nbsp;&nbsp;[\*\*\*] | [\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | [\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | [\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | [\*\*\*] |
| &nbsp;&nbsp;**Total [\*\*\*] Milestones** | **[\*\*\*]** |

---

[\*\*\*]

[\*\*\*]

[\*\*\*]

<u>2.</u><u>Royalties/Earn-Out Payment.</u> Notwithstanding the earn-out payment set forth in Section <br>5.2.1 of the TAK-228 APA, [\*\*\*], Faeth shall pay Takeda an earn-out payment on the Annual Net Sales (as defined in TAK-228 APA) of all 227+117 Combination Products by or on behalf of Faeth, its Affiliates or Licensees in a given Calendar Year (or partial Calendar Year) commencing with the First Commercial Sale of such 228+117 Combination Product in any country in the Territory, at the following rates, subject to [\*\*\*]:

---

| | |
|:---|:---|
| **<u>Annual Net Sales Increment</u>** | **<u>Earn-Out Payment Rate (%)</u>** |
| &nbsp;&nbsp;For the portion of the Annual Net Sales of such 228+117 Combination Product in any given Calendar Year which is [\*\*\*] | [\*\*\*]% |

---

------

---

| | |
|:---|:---|
| &nbsp;&nbsp;For the portion of the Annual Net Sales of such 228+117 Combination Product in any given Calendar Year which is [\*\*\*] | [\*\*\*]% |
| &nbsp;&nbsp;For the portion of the Annual Net Sales of such 228+117 Combination Product in any given Calendar Year which is [\*\*\*] | [\*\*\*]% |

---

For clarity, royalty payments set forth in Section 5.6 of the TAK-117 License Agreement will remain in full force and effect with respect to any Product (as defined in the TAK-117 License Agreement).

<u>3.</u><u>Miscellaneous.</u> 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1 The TAK-228 APA, this Letter Agreement and the TAK-117 License Agreement constitute the entire agreement between the Parties as to the subject matter of this Letter Agreement. Except as otherwise expressly set forth in this Letter Agreement, the TAK-228 APA shall remain in full force and effect in accordance with its terms.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2 [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.3 Faeth agrees that it shall not disclose this Letter Agreement or any discussions pertaining hereto to any Third Parties and that, in addition to and to the extent not inconsistent with the foregoing, this Letter Agreement and all discussions pertaining hereto are subject to Article 7 (Confidentiality) of the TAK-228 APA.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.4 Neither this Letter Agreement nor any right, interest or obligation of a Party under this Letter Agreement may be assigned by either Party without the written consent of the other Party, except that each Party may assign this Letter Agreement and the rights, obligations and interests of such Party to an Affiliate (as defined in the TAK-228 APA) of such Party to whom the TAK-228 APA is assigned. Any attempted assignment in contravention of this Section 3.4 shall<br>be void.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.5 This Letter Agreement may be executed in counterparts by a single Party, each of which when taken together shall constitute one and the same agreement. Counterparts may be delivered via facsimile, electronic mail (including .pdf or any electronic signature complying with

------

the U.S. federal ESIGN Act of 2000, Uniform Electronic Transactions Act or other applicable law) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6 This Letter Agreement and its effect are subject to and shall be construed and enforced in accordance with the law of the State of New York, without regard to its conflicts of laws that would require the application of any other Law. Each of the Parties hereby irrevocably and unconditionally consents to submit to the exclusive jurisdiction of the federal courts located<br>in the Southern District of the State of New York for any matter arising out of or relating to this Letter Agreement and the transactions contemplated hereby, and agrees not to commence any litigation relating thereto except in such courts. Each of the Parties hereby irrevocably and unconditionally waives any objection to the laying of venue of any matter arising out of this Letter Agreement or the transactions contemplated hereby in the courts of the State of New York and hereby further irrevocably and unconditionally waives and agrees not to plead or claim in any such court that any such matter brought in any such court has been brought in an inconvenient forum. The Parties agree that a final judgment in any such matter shall be conclusive and may be enforced in other jurisdictions by suits on the judgment or in any other manner provided by law. Any proceeding brought by either Party under this Letter Agreement shall be exclusively conducted in the English language.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.7 To the fullest extent permitted by Law, each of the Parties irrevocably waives all right to trial by jury in any litigation arising out of or relating to this Letter Agreement or any of the transactions contemplated by this Letter Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.8 Nothing in this Letter Agreement shall be construed to require the commission of any act contrary to Law. If any one or more provisions of this Letter Agreement is held to be invalid, illegal or unenforceable, the affected provisions of this Letter Agreement shall be curtailed and limited only to the extent necessary to bring it within the applicable legal requirements and the validity, legality and enforceability of the remaining provisions of this Letter Agreement shall not in any way be affected or impaired thereby.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.9 A Party's consent to or waiver, express or implied, of the other Party's breach of<br>its obligations hereunder shall not be deemed to be or construed as a consent to or waiver of any other breach of the same or any other obligations of such breaching Party. A Party's failure to complain of any act, or failure to act, by the other Party, to declare the other Party in default, to insist upon the strict performance of any obligation or condition of this Letter Agreement or to exercise any right or remedy consequent upon a breach thereof, no matter how long such failure

------

continues, shall not constitute a waiver by such Party of its rights hereunder, of any such breach, or of any other obligation or condition. A Party's consent in any one instance shall not limit or waive the necessity to obtain such Party's consent in any future instance and in any event no consent or waiver shall be effective for any purpose hereunder unless such consent or waiver is in writing and signed by the Party granting such consent or waiver.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.10 Section headings used herein are for convenient reference only, and are not a part<br>of this Letter Agreement.

*(Signature Pages Immediately to Follow)*

**IN WITNESS WHEREOF**, this Letter Agreement has been executed by the Parties hereto all as of the date first above written.

**Millennium Pharmaceuticals, Inc. Faeth Therapeutics, Inc.**

By: <u>/s/</u> <u>Michael Martin</u> By:

Name: Michael Martin Name:

Title: Authorized Signatory Title:

------

**IN WITNESS WHEREOF**, this Letter Agreement has been executed by the Parties hereto all as of the date first above written.

**Millennium Pharmaceuticals, Inc. Faeth Therapeutics, Inc.**

By: By: <u>/s/ Anand Parikh</u> 

Name: Name: Anand Parikh

Title: Title: CEO

------

## Exhibit 10.23

Exhibit 10.23

*CERTAIN INFORMATION HAS BEEN EXCLUDED FROM THIS AGREEMENT (INDICATED BY "[\*\*\*]") BECAUSE SUCH INFORMATION IS BOTH (A) NOT MATERIAL AND (B) THE TYPE THAT THE REGISTRANT CUSTOMARILY AND ACTUALLY TREATS AS PRIVATE OR CONFIDENTIAL.*

**January 29, 2026 (the "Effective Date")**

***Millennium Pharmaceuticals, Inc.***

40 Landsdowne Street

Cambridge, MA 02139

United States

***Takeda Pharmaceutical Company Limited***

40 Landsdowne Street

Cambridge, MA 02139

United States

**Re: TAK-228 and TAK-117 Combination Product**

Faeth Therapeutics, Inc. ("**Faeth**") and Takeda Pharmaceutical Company Limited ("**Takeda Pharmaceutical**") are parties to that certain License Agreement dated March 18, 2019 ("**TAK-<br>117 License Agreement**"), pursuant to which, among other things, Faeth was granted an<br>exclusive, worldwide right and license to develop, commercialize or otherwise exploit TAK-117. Faeth and Millennium Pharmaceuticals, Inc. ("**Millennium**" and together with "**Takeda Pharmaceutical**", "**Takeda**") are parties to that certain Amended and Restated TAK 228 Asset Purchase Agreement dated May 15, 2023 ("**TAK-228 APA**"), pursuant to which, among other things, Faeth has acquired rights to develop, commercialize or otherwise exploit TAK-228. On May 15, 2023, Faeth and Millennium have entered into that certain letter agreement ("**First Letter Agreement**" and, together with the TAK-117 License Agreement and the TAK-228 APA, the "**Existing Agreements**") to specify, among other things, (a) that, notwithstanding anything to the contrary provided in the TAK-117 License Agreement or the TAK-228 APA, Faeth has, and will have, the right to develop, commercialize or otherwise exploit a Combination Product (as defined in the TAK-228 APA) that includes a Program Molecule (as defined in the TAK-228 APA) and<br>the Licensed Compound (as defined in the TAK-117 License Agreement) as the only active pharmaceutical or biological ingredients (such Combination Product, the "**228+117 Combination Product**") and (b) Faeth's payment obligations to Takeda with respect to such development, commercialization or other exploitation of 228+117 Combination Product by Faeth.

Under this second letter agreement ("**Second Letter Agreement**"), Faeth and Takeda (each, a "**Party**" and, collectively, "**Parties**") desire to amend the Existing Agreements in order to modify certain terms and conditions therein.

------

**1.** **Definitions**. Capitalized terms used in this Second Letter Agreement shall have the meanings set forth in the Existing Agreements, unless otherwise defined in this Second Letter Agreement.

**2.** **Amendments to TAK-117 License Agreement**.

 **2.1** The following sentence is hereby added to the end of Section 1.30 (Definition of "Product") of the TAK-117 License Agreement:

"For clarity, Product includes the 228+117 Combination Product."

 **2.2** The following is hereby added to Article 1 (Definitions) of the TAK-117 License Agreement as a new definition, in alphanumerical order with the other definitions contained therein:

"**228+117 Combination Product Know-How**" means Know-How that is listed in [\*\*\*] of <u>Exhibit B</u> (Takeda Know-How) or any document referenced therein, solely to the extent it relates to a 228+117 Combination Product."

 **2.3** Section 1.36 (Definition of "Takeda Know-How") of the TAK-117 License Agreement is hereby amended and restated in its entirety as follows:

"**1.36** "**Takeda Know-How**" means any Know-How that is listed in <u>Exhibit B</u> or<br>any document referenced therein, solely to the extent it relates to a Licensed Compound or Product, including the 228+117 Combination Product Know-How. For clarity, except for<br>the 228+117 Combination Product Know-How, Know-How that relates to a Licensed Compound or Product in combination with any other compound, molecule, substance, or product is explicitly excluded from Takeda Know-How."

 **2.4** <u>Exhibit B</u> (Takeda Know-How) of the TAK-117 License Agreement is hereby amended and restated in its entirety as follows:

**<u>Takeda Know-How</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a.[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b.[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c.[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;d.[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.5** Section 5.2 (Equity Grant) of the TAK-117 License Agreement is hereby deleted in its entirety and replaced by the following:

------

"**5.2** [Intentionally omitted.]"

**3. Amendments to TAK-228 APA**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.1** The definition of "Product" set forth in Article 1 (Definitions) of the TAK-228 APA is hereby amended and restated in its entirety as follows:

""**Product**" means any product that contains or comprises a Program Molecule, alone or in combination with one or more Additional Active(s), in any formulation or dosage form and for any mode of administration; provided that, in no event will any Product include any Takeda Compounds (other than serabelisib (TAK-117)). For clarity, Product includes the 228+117 Combination Product."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.2** The following is hereby added to Article 1 (Definitions) of the TAK-228 APA as a new definition, in alphanumerical order with the other definitions contained therein:

""**228+117 Combination Product Know-How**" means Know-How that is listed in [\*\*\*] of <u>Schedule 2.6</u> (Licensed Intellectual Property) or any document referenced therein, solely to the extent it relates to a 228+117 Combination Product."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.3** Section 2.6 (Licensed Intellectual Property) of the TAK-228 APA is hereby amended and restated in its entirety as follows:

"**2.6 Licensed Intellectual Property**. To the extent Seller or its Affiliate Controls any<br>Patent Rights or Know-How (a) as of the Closing Date; or (b) on or after the Closing Date and (A) included in the Transaction IP, (B) Controlled pursuant to a Non-Assignable Contract or Related Agreement, in each case (A) and (B) pursuant to <u>Section 4.3,</u> or (C) constituting Section 2.5(b) IP, that in each case (a) and (b) are necessary to research and develop, make, have made, use, sell,<br>offer for sale, and import Products (including researching, developing, and making Program Molecules for the purpose of exercising such license with respect to Products) in the Field in the Territory and that are not included in Assigned Intellectual Property or licensed under the Assigned Agreements ("**Licensed Intellectual Property**"), Seller hereby grants Buyer a non-exclusive license under and to such Licensed Intellectual Property, with the right to grant sublicenses through multiple tiers, for the sole purpose of researching, developing, making, having made, using and importing Program Molecules and researching and developing, making, having made, using, selling, offering for sale, and importing Products in the Field in the Territory; provided, that Licensed Intellectual Property does not include any Patent Rights or Know-How that relate to a Program Molecule or Product in combination with a Takeda Compound (but for clarity, Licensed Intellectual Property does include the 228+117 Combination Product Know-How). Each<br>sublicense shall be consistent with the terms and conditions of this Agreement, including requiring each such sublicensee to protect and keep confidential any Confidential Information of the Parties in accordance with <u>Article 7</u> of this Agreement. For clarity, Licensed Intellectual Property, other than Section 2.5(b) IP, does not include Patent Rights or Know-How owned by Seller or its Affiliate that solely relate to any Program Molecule, which is included in Assigned Intellectual Property. <u>Schedule 2.6</u> sets forth the Licensed Intellectual Property as of the Closing Date; such schedule may be updated by the Parties from time to time. For clarity, to the extent any Know-<br>How listed in <u>Schedule 2.6</u> or the documents referenced therein relates to a compound, molecule, substance, or product other than a Program Molecule, a Licensed Compound (as defined in the TAK-117 License Agreement), or a 228+117 Combination Product, such Know-How is excluded from the Licensed Intellectual Property. Without limiting the foregoing, with respect to Patent

------

Rights included in Section 2.5(b) IP, Buyer shall have the right to notify Seller that it desires to obtain an exclusive license with respect thereto for the sole purpose of researching, developing, making, have made, using and importing Program Molecules and researching and developing, making, having made, using, selling, offering for sale, and importing Products in the Field in the Territory, and upon receipt of any such notification the Parties shall negotiate in good faith appropriate financial consideration to be provided by Buyer to Seller for such an exclusive license to the extent that Seller has the right and ability to grant such a license; provided that neither Party has an obligation to enter into any such exclusive license."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.4** <u>Schedule 2.6</u> (Licensed Intellectual Property) of the TAK-228 APA is hereby

amended and restated in its entirety as follows:

**<u>Schedule 2.6</u>**

**<u>Licensed Intellectual Property</u>**

[\*\*\*]

**4. Amendments to First Letter Agreement**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.1** Section 1 (228+117 [\*\*\*] Milestone Payments) of the First Letter Agreement is hereby amended and restated in its entirety as follows:

"1. <u>228+117 [\*\*\*] Milestone Payments.</u> Notwithstanding the milestones set forth in Section 5.3 of the TAK-228 APA and the milestones set forth in Section 5.3 of the TAK-117 License Agreement, the following development milestone events set forth in the table below (each a "[\*\*\*] **Milestone Event**") shall apply in lieu of (and supersede) Section 5.3 of the TAK-228 APA and Section 5.3 of the TAK-117 License Agreement. Following the first achievement by Faeth (or any of its Affiliates, Licensees, or Sublicensees, as applicable) of each [\*\*\*] Milestone Event with respect to the first Non-228+117 Combination Product or 228+117 Combination Product, as applicable, to achieve such [\*\*\*] Milestone Event, Faeth shall pay, or cause to be paid, to Takeda a one-time, non-refundable and non-creditable corresponding milestone payment (each, a "[\*\*\*] **Milestone Payment**") within [\*\*\*]. Faeth shall notify Takeda within [\*\*\*] after each [\*\*\*] Milestone Event is first achieved. For the avoidance of doubt, each [\*\*\*] Milestone Payment shall be payable one (1) time upon the first achievement of the corresponding [\*\*\*] Milestone Event with respect to an applicable Non-228+117 Combination Product<br>or 228+117 Combination Product, regardless of the number of times such [\*\*\*] Milestone Event may be achieved by the same or different Non-228+117 Combination Products or 228+117 Combination Products. For purposes of the foregoing, "Indication" shall have the meaning set forth in the TAK-228 APA.

---

| | | | |
|:---|:---|:---|:---|
| &nbsp;&nbsp;**[\*\*\*] Milestone Event** | &nbsp;&nbsp;**[\*\*\*] Milestone Payments** | &nbsp;&nbsp;**[\*\*\*] Milestone Payments** | &nbsp;&nbsp;**[\*\*\*] Milestone Payments** |
|  | &nbsp;&nbsp;**[\*\*\*]** | &nbsp;&nbsp;**[\*\*\*]** | &nbsp;&nbsp;**[\*\*\*]** |
| &nbsp;&nbsp;[\*\*\* | &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] |

---

------

---

| | | |
|:---|:---|:---|
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;**Total [\*\*\*] Milestone Payments** | **$119000000** | **$119000000** |

---

\*A "**Non-228+117 Combination Product**" means any Product (as defined under the TAK-228 APA or TAK-117 License Agreement) other than a 228+117 Combination Product. Without limiting the generality of the foregoing, "Non-228+117 Combination Product" includes each of the following: [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.2** Section 2 (Royalties/Earn-Out Payment) of the First Letter Agreement is hereby amended and restated in its entirety as follows:

"2. <u>Royalties/Earn-Out Payment.</u> Notwithstanding Section 5.2.1 of the TAK-228 APA and Section 5.6 of the TAK-117 License Agreement, the following payments shall apply in lieu of (and supersede) the earn-out payments set forth in Section 5.2.1 of the TAK-228 APA and the royalty payments set forth in Section 5.6 of the TAK-117 License Agreement, in each case solely with respect to 228+117 Combination Products. Faeth shall pay Takeda earn-out payments on the worldwide, Annual Net Sales (as defined in TAK-228 APA) of all 228+117 Combination Products in the aggregate by or on behalf of Faeth, its Affiliates, Licensees, or Sublicensees in a given Calendar Year (or partial Calendar Year) commencing with the First Commercial Sale of such 228+117 Combination Product in any country in the Territory, at the following rates set forth in this Section 2, subject to Section 5.2.3 (Earn-Out Payment Reduction) of the TAK-228 APA:

---

| | |
|:---|:---|
| **<u>Annual Net Sales Increment</u>** | **<u>Earn-Out Payment Rate (%)</u>**  |
| &nbsp;&nbsp;For the portion of the Annual Net Sales of such 228+117 Combination Product, in any given Calendar Year which is [\*\*\*] | [\*\*\*]% |
| &nbsp;&nbsp;For the portion of the Annual Net Sales of such 228+117 Combination Product, in any given Calendar Year which is [\*\*\*] | [\*\*\*]% |

---

------

---

| | |
|:---|:---|
| &nbsp;&nbsp;For the portion of the Annual Net Sales of such 228+117 Combination Product, in any given Calendar Year which is [\*\*\*] | [\*\*\*]% |

---

For clarity, royalty payments set forth in Section 5.6 of the TAK-117 License Agreement and earn-out payments set forth in Section 5.2.1 of the TAK-228 APA will remain in full force and effect with respect to any Product (as defined in each of the TAK-228 APA and TAK-117 License Agreement) that is not a 228+117 Combination Product."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.3** The following is hereby added to the First Letter Agreement as a new Section 2-A

after Section 2 (Royalties/Earn-Out Payment) and before Section 3 (Miscellaneous):

"2-A. Notwithstanding the milestones set forth in Section 5.4 of the TAK-228 APA and Section 5.4 of the TAK-117 License Agreement, the following sales milestone events set forth in the table below (each, a "**Sales Milestone Event**") and corresponding sales milestone payments<br>set forth in the table below (each, a "**Sales Milestone Payment**") shall apply in lieu of (and supersede) Section 5.4 of the TAK-228 APA and Section 5.4 of the TAK-117 License Agreement. The Initial Earn-Out Report and the Earn-Out Report to be issued pursuant to Section 5.2.4 of the TAK-228 APA shall each indicate whether any Sales Milestone Event was achieved during the [\*\*\*] covered by such report. Upon receipt of an Earn-Out Report indicating that a Sales Milestone Event was achieved, Takeda will issue an invoice to Faeth for the Sales Milestone Payment payable under this Section 2-A. Faeth will pay all Sales Milestone Payments payable under this Section 2-A within [\*\*\*]. For the avoidance of doubt, each Sales Milestone Payment shall be payable one time upon the first achievement of the corresponding Sales Milestone Event, regardless of the number of times such Sales Milestone Event may be achieved.

---

| | |
|:---|:---|
| **Sales Milestone Event** | **Sales Milestone Payment** |
| &nbsp;&nbsp;Annual Net Sales of all 228+117 Combination Products and/or Non- 228+117 Combination Products equals or exceeds $[\*\*\*] | $[\*\*\*] |
| &nbsp;&nbsp;Annual Net Sales of all 228+117 Combination Products and/or Non- 228+117 Combination Products equals or exceeds $[\*\*\*] | $[\*\*\*] |
| &nbsp;&nbsp;Annual Net Sales of all 228+117 Combination Products and/or Non- 228+117 Combination Products equals or exceeds $[\*\*\*] | $[\*\*\*] |
| &nbsp;&nbsp;Annual Net Sales of all 228+117 Combination Products and/or Non- 228+117 Combination Products equals or exceeds $[\*\*\*] | $[\*\*\*] |
| &nbsp;&nbsp;**Total Sales Milestone Payments** | $250000000 |

---

"

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.4** Section 3.2 of the First Letter Agreement is hereby deleted in its entirety and

replaced by the following:

"3.2 [Intentionally omitted.]"

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.5** Section 3.4 of the First Letter Agreement is hereby amended and restated in its

------

entirety as follows:

"3.4 Neither this Letter Agreement nor any right, interest or obligation of a Party under<br>this Letter Agreement may be assigned by either Party without the written consent of the other<br>Party, except that each Party may assign this Letter Agreement and the rights, obligations and interests of such Party to an Affiliate (as defined in the TAK-228 APA) of such Party or in connection with the transfer or sale of all or substantially all of the business of such Party to which this Agreement relates, whether by merger, sale of stock, sale of assets or otherwise. Any attempted assignment in contravention of this Section 3.4 shall be void."

**5. Authorization to Communicate with Vendors**. Notwithstanding Section 2.9

(Authorization to Communicate with Vendors) of the TAK-117 License Agreement, Takeda shall, upon Faeth's request during the [\*\*\*] period following the Effective Date of this Second Letter Agreement, [\*\*\*] submit letters to vendors that have been or are involved in Development or manufacture of (a) TAK-117 (or other Licensed Compound), (b) TAK-228 (or other Program Molecule), or (c) any intermediates, regulatory starting materials, drug substance, drug product, and studies relating to (a) or (b), the purpose of which letters shall be to instruct each of such vendors to provide to Faeth access to all 228+117 Combination Product Know-How that Faeth is entitled to possess under this Second Letter Agreement, provided that [\*\*\*].

**6.** **Transfer of 228+117 Combination Product Know-How; Treatment of Unrelated Know-How.** Takeda will transfer to Faeth or permit Faeth to obtain the 228+117 Combination Product Know-How in accordance with the process and timing detailed in the transition plan set forth in Exhibit A of this Second Letter Agreement. [\*\*\*]. Notwithstanding anything to the contrary in this Second Letter Agreement including Exhibit A hereto, the First Letter Agreement, the TAK-117 License Agreement, or the TAK-228 APA, Takeda's obligations to conduct or assist with transferring such 228+117 Combination Product Know-How shall terminate [\*\*\*] after [\*\*\*]. In the event of a conflict between this Second Letter Agreement and the terms set forth in Exhibit A hereto, this Second Letter Agreement will prevail. If either Party becomes aware that any know-how, information, data, documents, or other materials transferred to Faeth pursuant to this Section 6 relates to a compound, molecule, substance, or product other than a Program Molecule (as defined in the TAK-228 APA), a Licensed Compound (as defined in the TAK-117 License Agreement), or a 228+117 Combination Product, such Party shall promptly notify the other Party thereof, and promptly upon Takeda's request, Faeth shall return or destroy (at Takeda's sole discretion) such know-how, information, data, documents, and other materials.

**7.** **Payment.** In partial consideration for the rights granted herein to Faeth, Faeth shall pay to Takeda a one-time, non-refundable and non-creditable payment of [\*\*\*].

**8.** **No Other Amendments and No New Takeda Obligations**. Except as otherwise<br>expressly set forth in this Second Letter Agreement, the Existing Agreements shall remain in full force and effect in accordance with their terms. Except for the transfer of 228+117 Combination Product Know-How pursuant to Section 6 (Transfer of 228+117 Combination Product Know-<br>How) of this Second Letter Agreement, [\*\*\*]. Faeth acknowledges it has received, prior to the Effective Date of this Second Letter Agreement, and agrees that [\*\*\*].

**9.** **Miscellaneous**.

------

 **9.1** The Existing Agreements and this Second Letter Agreement constitute the entire agreement between the Parties as to the subject matter of this Second Letter Agreement.

 **9.2** Faeth agrees that it shall not disclose this Second Letter Agreement or any

discussions pertaining hereto to any Third Parties and that, in addition to and to the extent not inconsistent with the foregoing, this Second Letter Agreement and all discussions pertaining hereto are subject to Article 7 (Confidentiality) of the TAK-228 APA.

**9.3** Neither this Second Letter Agreement nor any right, interest or obligation of a Party under this Second Letter Agreement may be assigned by either Party without the written consent of the other Party, except that each Party may assign this Second Letter Agreement and the rights, obligations and interests of such Party in connection with such Party's assignment of the TAK- 228 APA and the TAK-117) of such Party or in connection with the transfer or sale of all or substantially all of the business of such Party to which this Agreement relates, whether by merger, sale of stock, sale of assets or otherwise. Any attempted assignment in contravention of this Section 7.3 shall be void.

**9.4** This Second Letter Agreement may be executed in counterparts by a single Party, each of which when taken together shall constitute one and the same agreement. Counterparts may be delivered via facsimile, electronic mail (including .pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, Uniform Electronic Transactions Act or other applicable law) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.

**9.5** This Second Letter Agreement and its effect are subject to and shall be construed and enforced in accordance with the law of the State of New York, without regard to its conflicts of laws that would require the application of any other Law. Each of the Parties hereby irrevocably and unconditionally consents to submit to the exclusive jurisdiction of the federal courts located in the Southern District of the State of New York for any matter arising out of or relating to this Second Letter Agreement and the transactions contemplated hereby, and agrees not to commence any litigation relating thereto except in such courts. Each of the Parties hereby irrevocably and unconditionally waives any objection to the laying of venue of any matter arising out of this Second Letter Agreement or the transactions contemplated hereby in the courts of the State of New York and hereby further irrevocably and unconditionally waives and agrees not to plead or claim in any such court that any such matter brought in any such court has been brought in an inconvenient forum. The Parties agree that a final judgment in any such matter shall be conclusive and may be enforced in other jurisdictions by suits on the judgment or in any other manner provided by law. Any proceeding brought by either Party under this Second Letter Agreement shall be exclusively conducted in the English language.

**9.6** To the fullest extent permitted by Law, each of the Parties irrevocably waives all right to trial by jury in any litigation arising out of or relating to this Second Letter Agreement or any of the transactions contemplated by this Second Letter Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.7** Nothing in this Second Letter Agreement shall be construed to require the commission of any act contrary to Law. If any one or more provisions of this Second Letter Agreement is held to be invalid, illegal or unenforceable, the affected provisions of this Second Letter Agreement shall be curtailed and limited only to the extent necessary to bring it within the applicable legal requirements and the validity, legality and enforceability of the remaining provisions of this Second Letter Agreement shall not in any way be affected or impaired thereby.

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **9.8** A Party's consent to or waiver, express or implied, of the other Party's breach of its obligations hereunder shall not be deemed to be or construed as a consent to or waiver of any other breach of the same or any other obligations of such breaching Party. A Party's failure to complain of any act, or failure to act, by the other Party, to declare the other Party in default, to insist upon the strict performance of any obligation or condition of this Second Letter Agreement or to exercise any right or remedy consequent upon a breach thereof, no matter how long such failure continues, shall not constitute a waiver by such Party of its rights hereunder, of any such breach, or of any other obligation or condition. A Party's consent in any one instance shall not limit or waive the necessity to obtain such Party's consent in any future instance and in any event no consent or waiver shall be effective for any purpose hereunder unless such consent or waiver is in writing and signed by the Party granting such consent or waiver.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 9.9 Section headings used herein are for convenient reference only, and are not a part of this Second Letter Agreement.

------

[*Signature Pages Immediately to Follow*]

**In Witness Whereof**, this Second Letter Agreement has been executed by the Parties

hereto all as of the Effective Date of this Second Letter Agreement.

**Takeda Pharmaceutical Company Limited Faeth Therapeutics, Inc.**

By: <u>/s/</u> <u>Eiko Sakai</u> By: <u>/s/ Anand Parikh</u> 

Name: <u>Eiko Sakai</u> Name: <u>Anand Parikh</u> 

Title: Lead, Global Alliance Management,<br> <u>Global</u> Title: <u>CEO</u> 

**Millennium Pharmaceuticals, Inc.**

By: <u>/s/</u> <u>Bathery John</u> 

Name: <u>Bathery John</u> 

Title: <u>Head, Business Development Operations</u>

------

**Exhibit A**

**Tech Transfer Plan**

[\*\*\*]

------

## Exhibit 10.24

Exhibit 10.24

December 22, 2025

Christopher W. Gerry

**RE: Retention Agreement and Offer of Additional Severance Eligibility** 

Dear Chris:

Thank you for all of your contributions to Sensei Biotherapeutics, Inc. (the "***Company***"). Your role is critical to the next phase of the Company. Our hope is that you will remain employed with the Company. To financially incentivize you to remain employed by the Company, we are pleased to offer you two retention bonuses in the form of more favorable bonus eligibility terms for the 2025 and 2026 calendar years and potential additional severance eligibility, according to the terms below (the "***Retention Agreement***"). Capitalized terms not defined in this Retention Agreement shall have the same meaning as set forth in the Employment Agreement (as defined below).

**<u>Modifications of Base Salary and Target Percentage</u>**

This is to confirm our agreement that, effective as of November 14, 2025, your Base Salary increased to $425,000.

Additionally, for any Annual Bonus that you may be eligible to receive attributable to the 2026 calendar year, your Target Percentage shall be increased to 40% of your then-current Base Salary (the "***Modified Target Percentage***"). For the avoidance of doubt, the Modified Target Percentage shall not apply to your Annual Bonus attributable to the 2025 calendar year.

For avoidance of any doubt, your Employment Agreement is amended and modified with respect to these compensation modifications as described herein.

**<u>Retention Bonus</u>**

***First Retention Bonus***

If you remain employed by the Company through February 13, 2026 (the "***Earn Date***"), and provided you have not tendered your resignation before such date and the Company has not terminated your employment for Cause (as defined in your Amended and Restated Employment Agreement, dated as of July 31, 2024 (the "***Employment Agreement***")) before the Earn Date, then, notwithstanding the fact that the Company is unlikely to attain the targeted goals set by the Board of Directors for 2025 and actual bonus calculations would likely be decreased on account of overall economic conditions and related financial factors, you will nevertheless be entitled to receive, an amount equal to your Annual Bonus attributable to the 2025 calendar year, calculated at the full Target Percentage set forth in your Employment Agreement (the "***First Retention Bonus***"). If earned, the First Retention Bonus will be paid in a lump sum on February 13, 2026, and will be subject to applicable payroll withholdings and deductions. For the avoidance of doubt, the First Retention Bonus will be in lieu of, not in addition to, any other bonus attributable to the 2025 calendar year that you might otherwise be eligible to receive under Section 2.2 of your Employment Agreement.

If the Company terminates your employment without Cause or you terminate your employment for Good Reason, in either case, prior to February 13, 2026 and ***<u>not</u>*** during the Change in Control Measurement Period, then, subject to your full compliance with Section 6.1(c) of the Employment Agreement, including but not limited to the Release requirement and your continued compliance with obligations to the Company under your Covenants Agreement (as defined below), as an additional Non-CIC Severance Benefit under Section 6.1 of your Employment Agreement, the

------

Company will pay the First Retention Bonus, less applicable taxes and withholdings (the "***Termination Bonus***"). The Termination Bonus will be paid on the next regular payroll date after the Release has become effective.

***Second Retention Bonus***

Additionally, notwithstanding anything to the contrary in Section 2.2 of your Employment Agreement, if the Company terminates your employment without Cause or you terminate your employment for Good Reason, in either case, prior to the date that bonuses are paid in respect of the 2026 calendar year, then, subject to your full compliance with Section 6.1(c) of the Employment Agreement, you will be eligible to receive an amount equal to 1/12 of the Annual Bonus attributable to the 2026 calendar year, calculated at the full Modified Target Percentage, multiplied by the number of full months that you were employed by the Company in 2026 (the "***Second Retention Bonus***"). The Second Retention Bonus will be paid on the next regular payroll date after the Release has become effective.

**<u>Additional Non-CIC Severance Benefit</u>**

If the Company terminates your employment without Cause or you terminate your employment for Good Reason, in either case, at any time during the 2026 calendar year ***<u>except</u>*** during the Change in Control Measurement Period, then, subject to your full compliance with Section 6.1(c) of the Employment Agreement, as an additional Non-CIC Severance Benefit under Section 6.1 of your Employment Agreement, you will receive an amount equal to two times the Second Retention Bonus described in the previous paragraph, and calculated based on the applicable separation date. For the avoidance of doubt, if this additional severance benefit is payable to you, you agree that you will not have any right to receive otherwise, the Second Retention Bonus and/or any annual bonus in respect of the 2026 calendar year.

**<u>Miscellaneous</u>**

This Retention Agreement is intended to provide a financial incentive to you and is not intended to confer any rights to continued employment upon you. Nothing in this Retention Agreement is intended to alter your at-will employment relationship, and except as otherwise modified herein with respect to your Base Salary, Target Percentage, bonus eligibility and severance eligibility, all other provisions of the Employment Agreement and your Employee Confidential Information, Invention Assignment, Non-Solicitation and Non-Competition Agreement (the "***Covenants Agreement***") remain in full force and effect.

All questions concerning the construction, validity and interpretation of this Retention Agreement will be governed by the laws of the state or commonwealth in which you primarily provide services for the Company.

This Retention Agreement is the complete, final and exclusive embodiment of the entire agreement between you and the Company with regard to the benefits provided for herein, and it supersedes and replaces any other agreements (whether written or unwritten) you may have with the Company concerning these matters (other than the Covenants Agreement and, except as explicitly modified herein, the Employment Agreement, both of which remain in full force and effect). The terms of this Retention Agreement may not be modified or amended except in a written agreement signed by you and a duly authorized officer of the Company.

[Signature Page Follows]

------

If you would like to accept the Company's offer herein, please sign below and return to me on or before December 31, 2025.

Sincerely,

<u>/s/ Bob Holmen</u>_____________

Name: Bob Holmen

Title: Chairman of the Board

Accepted and Agreed:

<u>/s/ Christopher W. Gerry</u> Date:<u>12/22/2025</u>

Christopher W. Gerry

------

## Exhibit 10.25

Exhibit 10.25

December 22, 2025

Josiah Craver

**RE: Retention Agreement and Offer of Additional Severance Eligibility** 

Dear Josiah:

Thank you for all of your contributions to Sensei Biotherapeutics, Inc. (the "***Company***"). Your role is critical to the next phase of the Company. Our hope is that you will remain employed with the Company. To financially incentivize you to remain employed by the Company, we are pleased to offer you two retention bonuses in the form of more favorable bonus eligibility terms for the 2025 and 2026 calendar years and potential additional severance eligibility, according to the terms below (the "***Retention Agreement***"). Capitalized terms not defined in this Retention Agreement shall have the same meaning as set forth in the Employment Agreement (as defined below).

**<u>Modifications of Base Salary and Target Percentage</u>**

This is to confirm our agreement that, effective as of November 14, 2025, your Base Salary increased to $400,000.

Additionally, for any Annual Bonus that you may be eligible to receive attributable to the 2026 calendar year, your Target Percentage shall be increased to 40% of your then-current Base Salary (the "***Modified Target Percentage***"). For the avoidance of doubt, the Modified Target Percentage shall not apply to your Annual Bonus attributable to the 2025 calendar year.

For avoidance of any doubt, your Employment Agreement is amended and modified with respect to these compensation modifications as described herein.

**<u>Retention Bonus</u>**

***First Retention Bonus***

If you remain employed by the Company through February 13, 2026 (the "***Earn Date***"), and provided you have not tendered your resignation before such date and the Company has not terminated your employment for Cause (as defined in your Employment Agreement, dated as of July 12, 2024 (the "***Employment Agreement***")) before the Earn Date, then, notwithstanding the fact that the Company is unlikely to attain the targeted goals set by the Board of Directors for 2025 and actual bonus calculations would likely be decreased on account of overall economic conditions and related financial factors, you will nevertheless be entitled to receive, an amount equal to your Annual Bonus attributable to the 2025 calendar year, calculated at the full Target Percentage set forth in your Employment Agreement (the "***First Retention Bonus***"). If earned, the First Retention Bonus will be paid in a lump sum on February 13, 2026, and will be subject to applicable payroll withholdings and deductions. For the avoidance of doubt, the First Retention Bonus will be in lieu of, not in addition to, any other bonus attributable to the 2025 calendar year that you might otherwise be eligible to receive under Section 2.2 of your Employment Agreement.

If the Company terminates your employment without Cause or you terminate your employment for Good Reason, in either case, prior to February 13, 2026 and ***<u>not</u>*** during the Change in Control Measurement Period, then, subject to your full compliance with Section 6.1(c) of the Employment Agreement, including but not limited to the Release requirement and your continued compliance with obligations to the Company under your Covenants Agreement (as defined below), as an additional Non-CIC Severance Benefit under Section 6.1 of your Employment Agreement, the Company will pay the First Retention Bonus, less applicable taxes and withholdings (the

------

"***Termination Bonus***"). The Termination Bonus will be paid on the next regular payroll date after the Release has become effective.

***Second Retention Bonus***

Additionally, notwithstanding anything to the contrary in Section 2.2 of your Employment Agreement, if the Company terminates your employment without Cause or you terminate your employment for Good Reason, in either case, prior to the date that bonuses are paid in respect of the 2026 calendar year, then, subject to your full compliance with Section 6.1(c) of the Employment Agreement, you will be eligible to receive an amount equal to 1/12 of the Annual Bonus attributable to the 2026 calendar year, calculated at the full Modified Target Percentage, multiplied by the number of full months that you were employed by the Company in 2026 (the "***Second Retention Bonus***"). The Second Retention Bonus will be paid on the next regular payroll date after the Release has become effective.

**<u>Additional Non-CIC Severance Benefit</u>**

If the Company terminates your employment without Cause or you terminate your employment for Good Reason, in either case, at any time during the 2026 calendar year ***<u>except</u>*** during the Change in Control Measurement Period, then, subject to your full compliance with Section 6.1(c) of the Employment Agreement, as an additional Non-CIC Severance Benefit under Section 6.1 of your Employment Agreement, you will receive an amount equal to two times the Second Retention Bonus described in the previous paragraph, and calculated based on the applicable separation date. For the avoidance of doubt, if this additional severance benefit is payable to you, you agree that you will not have any right to receive otherwise, the Second Retention Bonus and/or any annual bonus in respect of the 2026 calendar year.

**<u>Miscellaneous</u>**

This Retention Agreement is intended to provide a financial incentive to you and is not intended to confer any rights to continued employment upon you. Nothing in this Retention Agreement is intended to alter your at-will employment relationship, and except as otherwise modified herein with respect to your Base Salary, Target Percentage, bonus eligibility and severance eligibility, all other provisions of the Employment Agreement and your Employee Confidential Information, Invention Assignment, Non-Solicitation and Non-Competition Agreement (the "***Covenants Agreement***") remain in full force and effect.

All questions concerning the construction, validity and interpretation of this Retention Agreement will be governed by the laws of the state or commonwealth in which you primarily provide services for the Company.

This Retention Agreement is the complete, final and exclusive embodiment of the entire agreement between you and the Company with regard to the benefits provided for herein, and it supersedes and replaces any other agreements (whether written or unwritten) you may have with the Company concerning these matters (other than the Covenants Agreement and, except as explicitly modified herein, the Employment Agreement, both of which remain in full force and effect). The terms of this Retention Agreement may not be modified or amended except in a written agreement signed by you and a duly authorized officer of the Company.

[Signature Page Follows]

------

If you would like to accept the Company's offer herein, please sign below and return to me on or before December 31, 2025.

Sincerely,

<u>/s/ Christopher Gerry</u> 

Name: Christopher Gerry

Title: President and General Counsel

Accepted and Agreed:

<u>/s/ Josiah Craver</u> Date: <u>12/22/2025</u>

Josiah Craver

------

## Exhibit 21.1

Exhibit 21.1

![img84023607_0.jpg](img84023607_0.jpg)

------

## Exhibit 23.1

**Exhibit 23.1**

**CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM**

We consent to the incorporation by reference in Registration Statement No. 333-263567 on Form S-3 and Registration Statement Nos. 333-286207, 333-277532, 333-270946, 333-264827, and 333-252954 on Form S-8 of our report dated March 30, 2026, relating to the financial statements of Sensei Biotherapeutics, Inc. appearing in this Annual Report on Form 10-K for the year ended December 31, 2025.

/s/ Deloitte & Touche LLP

Baltimore, Maryland

March 30, 2026

------

## Exhibit 31.1

**Exhibit 31.1**

**CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER**

**PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002**

<br> I, Christopher W. Gerry, certify that:

1. I have reviewed this Annual Report on Form 10-K for the year ended December 31, 2025 of Sensei Biotherapeutics, Inc. (the "registrant");

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(s) 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:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(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;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(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;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(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

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(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(s) 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):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(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

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(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: March 30, 2026 | By: | /s/ Christopher W. Gerry |
|  |  | Christopher W. Gerry |
|  |  | President and General Counsel<br>(Principal Executive Officer)  |

---

------

## Exhibit 31.2

**Exhibit 31.2**

**<br>CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER**

**PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002**

I, Josiah Craver, certify that:

1. I have reviewed this Annual Report on Form 10-K for the year ended December 31, 2025 of Sensei Biotherapeutics, Inc. (the "registrant");

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(s) 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:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(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;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(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;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(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

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(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(s) 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):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(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

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(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.

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| | | |
|:---|:---|:---|
| Date: March 30, 2026 | By: | /s/ Josiah Craver |
|  |  | Josiah Craver |
|  |  | Senior Vice President, Finance<br>(Principal Financial Officer)  |

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## Exhibit 32.1

**Exhibit 32.1**

**<br>CERTIFICATIONS OF**

**PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER**

**PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO**

**SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002**

Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the "Exchange Act") and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Christopher W. Gerry, President and General Counsel of Sensei Biotherapeutics, Inc. (the "Company"), and Josiah Craver, Senior Vice President of Finance of the Company, each hereby certifies that, to the best of his knowledge:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) The Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, to which this Certification is attached as Exhibit 32.1 (the "Annual Report"), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

**IN WITNESS WHEREOF**, the undersigned have set their hands hereto as of the 30th day of March, 2026.

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| | |
|:---|:---|
| /s/ Christopher W. Gerry | /s/ Josiah Craver |
| Christopher W. Gerry | Josiah Craver |
| President and General Counsel<br>(Principal Executive Officer) | Senior Vice President of Finance<br>(Principal Financial Officer) |

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\* This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.

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