10-K

Kura Oncology, Inc. (KURA)

10-K 2025-02-28 For: 2024-12-31
View Original
Added on April 09, 2026

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(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, 2024

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 001-37620

KURA ONCOLOGY, INC.

(Exact name of Registrant as specified in its Charter)

Delaware 61-1547851
(State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.)
12730 High Bluff Drive, Suite 400, San Diego, CA 92130
(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (858) 500-8800

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

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock, par value $0.0001 per share KURA The Nasdaq Global Select Market

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

Large accelerated filer Accelerated filer
Non-accelerated filer Smaller reporting company
Emerging growth company

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

Indicate by check mark whether the registrant 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 ☒

The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant was approximately $1.6 billion as of June 28, 2024 (the last trading day of the registrant’s most recently completed second quarter) based on the closing price of $20.59 as reported on the Nasdaq Global Select Market on such date. Shares of the registrant’s common stock held by executive officers, directors and the registrant’s affiliates have been excluded from this calculation. This determination of affiliate status is not necessarily a conclusive determination for other purposes.

The number of outstanding shares of the registrant’s common stock as of February 20, 2025 was 80,754,961 shares.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the registrant’s definitive proxy statement to be filed with the Securities and Exchange Commission, or SEC, subsequent to the date hereof pursuant to Regulation 14A in connection with the registrant’s 2025 Annual Meeting of Stockholders, are incorporated by reference into Part III of this Annual Report on Form 10-K. Such proxy statement will be filed with the SEC not later than 120 days after the conclusion of the registrant’s fiscal year ended December 31, 2024.

Auditor Firm Id: 42 Auditor Name: Ernst & Young LLP Auditor Location: San Diego, CA USA

KURA ONCOLOGY, INC.

TABLE OF CONTENTS

Page
PART I
Item 1. Business 3
Item 1A. Risk Factors 32
Item 1B. Unresolved Staff Comments 78
Item 1C. Cybersecurity 78
Item 2. Properties 79
Item 3. Legal Proceedings 79
Item 4. Mine Safety Disclosures 79
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 80
Item 6. [Reserved] 81
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 82
Item 7A. Quantitative and Qualitative Disclosures About Market Risk 91
Item 8. Financial Statements and Supplementary Data 91
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 91
Item 9A. Controls and Procedures 92
Item 9B. Other Information 94
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 94
PART III
Item 10. Directors, Executive Officers and Corporate Governance 95
Item 11. Executive Compensation 95
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 95
Item 13. Certain Relationships and Related Transactions, and Director Independence 95
Item 14. Principal Accountant Fees and Services 95
PART IV
Item 15. Exhibit and Financial Statement Schedules 96
Item 16. Form 10-K Summary 100
SIGNATURES 101

ii

Forward-Looking Statements

This Annual Report on Form 10-K, or Annual Report, may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “targets,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements reflect our beliefs and opinions on the relevant subject and are based upon information available to us as of the date of this Annual Report. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Annual Report, we caution you that these statements are based on information that may be limited or incomplete, our projections of the future that are subject to known and unknown risks and uncertainties and other factors that may cause our actual results, level of activity, performance or achievements expressed or implied by these forward-looking statements, to differ. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements. The sections in this Annual Report entitled “Business,” “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” as well as other sections in this Annual Report, discuss some of the factors that could contribute to these differences. These forward-looking statements include, among other things, statements about:

  • the initiation, cost, timing, progress and results of our research and development activities, clinical trials and preclinical studies;
  • the early stage of products under development;
  • the timing of and our ability to obtain and maintain regulatory approval of our existing product candidates, any product candidates that we may develop, any clinical holds established by any relevant regulatory bodies and any related restrictions, limitations, and/or warnings in the label of any approved product candidates;
  • our plans to research, develop and commercialize our current and future product candidates;
  • our ability to attract and retain collaborators with development, regulatory and commercialization expertise;
  • our ability to obtain and maintain intellectual property protection for our product candidates;
  • our ability to successfully expand our sales capabilities and commercialize our product candidates;
  • the size and growth of the markets for our product candidates and our ability to serve those markets;
  • the rate and degree of market acceptance of any future products;
  • the success of competing drugs that are or become available;
  • government regulation;
  • regulatory developments in the United States and other countries;
  • the performance of our third-party suppliers and manufacturers and our ability to obtain alternative sources of raw materials;
  • the performance of our collaboration partners and the success of our collaborations;
  • our ability to obtain additional financing;
  • our use of cash, cash equivalents, investments and other resources;
  • the accuracy of our estimates regarding expenses, future revenues, capital requirements and the need for additional financing;
  • our ability to attract and retain key management, scientific, clinical or sales personnel; and
  • the impact of geopolitical events and actual or threatened public health epidemics and pandemics on our business and operations.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important cautionary statements in this Annual Report, particularly in the “Risk Factors” section, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.

You should read this Annual Report, and the documents that we reference in this Annual Report, completely and with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements contained in this Annual Report are made as of the date of this Annual Report, and we do not assume, and specifically disclaim, any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Unless the context requires otherwise, references in this Annual Report to “we,” “us” and “our” refer to Kura Oncology, Inc. In addition, our use of the word “including” in this Annual Report is not intended to be exhaustive but instead is intended to mean “including, without limitation.”

Risk Factor Summary

We face many risks and uncertainties, as more fully described in this section under the heading “Risk Factors.” Some of these risks and uncertainties are summarized below. The summary below does not contain all of the information that may be important to you, and you should read this summary together with the more detailed discussion of these risks and uncertainties contained in “Risk Factors.”

  • We are highly dependent on the success of our lead product candidate, ziftomenib, which is still in clinical development, and we cannot give any assurance that ziftomenib or any of our other product candidates will receive regulatory approval, which is necessary before they can be commercialized. Even if our product candidates receive regulatory approval and are commercialized, they may be less competitive and generate less revenue than we anticipate.

  • Our discovery, preclinical and clinical development activities are primarily focused on the development of targeted therapeutics for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop drugs may never lead to marketable products.

  • Clinical drug development involves a lengthy and expensive process with an uncertain outcome. The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of subsequent clinical trials, and preliminary or interim results of a clinical trial do not necessarily predict final 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.

  • We anticipate that our current product candidates and any future product candidates may be used in combination with third-party drugs or biologics, some of which may still be in development, and we have limited or no control over the supply, regulatory status, or regulatory approval of such drugs or biologics.

  • Our product candidates may cause serious adverse events or have unacceptable side effects that could delay, limit or prevent their development.

  • Failure by us or our third-party collaborators to develop, validate and obtain regulatory approval for a diagnostic testing platform could harm our drug development strategy and operational results.

  • We expect to incur losses over the next several years and may never achieve or maintain profitability.

  • We are a clinical-stage company with no approved products and no historical product revenue. Consequently, we expect that our financial and operating results will vary significantly from period to period.

  • We may need to obtain substantial additional capital in connection with our continuing operations. If we are required to raise additional capital, doing so may cause dilution to our stockholders, restrict our operations or require us to relinquish certain rights to our technologies or product candidates.

  • Our collaboration with Kyowa Kirin Co., Ltd. and Kyowa Kirin, Inc., or, collectively, Kyowa Kirin, is important to our business. If Kyowa Kirin ceases development efforts under our collaboration agreement, or if our collaboration agreement is terminated, we may not receive future milestone payments or royalties under the agreement.

  • We rely on third-party contractors and organizations to conduct, and/or to supply materials to conduct, our clinical trials and provide commercial supply, and those third parties may not perform satisfactorily, including failing to meet deadlines for the supply of materials and/or the completion of such clinical trials or to meet the demands of our commercial supply.

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

  • Any product candidate for which we obtain marketing approval will be subject to extensive post-approval regulatory requirements and could be subject to post-approval restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.

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

  • We depend on our licensors to prosecute and maintain patents and patent applications that are material to our business. Any failure by our licensors to effectively protect these intellectual property rights could adversely impact our business and operations.

  • Patent terms may be inadequate to protect our competitive position on our product candidates for a commercially meaningful length of time.

  • We may not be successful in obtaining or maintaining necessary third-party intellectual property rights for our development pipeline through acquisitions and in-licenses.

  • If we are unable to maintain the confidentiality of our trade secrets or other confidential information, our business and competitive position would be harmed.

  • 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.

  • We currently have a limited marketing, sales and distribution infrastructure. If we are unable to fully develop our sales capabilities or enter into agreements with third parties to sell or market our product candidates if they obtain regulatory approval, we may not be able to effectively sell or market our product candidates, if approved, or generate product revenues.

  • We face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do.

  • We are highly dependent on our Chief Executive Officer. Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.

  • Our stock price may fluctuate significantly and you may have difficulty selling your shares based on current trading volumes of our stock.

  • The price of our common stock may be volatile and may be influenced by numerous factors, some of which are beyond our control.

Item 1. Business.

Overview

We are a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Our pipeline consists of small molecule product candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes and, in general, we intend to pair our product candidates with molecular or cellular diagnostics to identify those patients most likely to respond to treatment.

Our lead product candidate is ziftomenib, a selective investigational inhibitor of the menin-KMT2A protein-protein interaction. We are developing ziftomenib for the treatment of genetically defined subsets of acute leukemias, including acute myeloid leukemia, or AML, and acute lymphoblastic leukemia, or ALL. In November 2024, we entered into a collaboration and license agreement with Kyowa Kirin to develop and commercialize ziftomenib for the treatment of patients with AML and other hematologic malignancies, which may be expanded into other indications at the option of Kyowa Kirin, subject to certain conditions. We also are exploring the use of ziftomenib for the treatment of gastrointestinal stromal tumors, or GIST, and

ziftomenib and our next-generation menin inhibitors for use in other indications, including type 2 diabetes and certain solid tumors.

Our second product candidate is KO-2806, a selective investigational farnesyl transferase inhibitor, or FTI, which we are evaluating as a monotherapy and as a companion inhibitor to certain targeted therapies in large solid tumor indications, including renal cell carcinoma, or RCC, and KRASG12C-mutant non-small cell lung cancer, or NSCLC.

Our third product candidate, tipifarnib, is a selective investigational FTI, which we are evaluating in combination with alpelisib, a PI3 kinase alpha inhibitor, in patients with head and neck squamous cell carcinoma, or HNSCC, whose tumors have HRAS overexpression and/or PIK3CA mutation and/or amplification.

We also have additional programs that are at a discovery stage. We plan to advance our product candidates through a combination of internal development and strategic partnerships while maintaining significant development and commercial rights.

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Our Strategy

Our strategy is to discover, acquire, develop and commercialize innovative anti-cancer agents in oncology indications with significant unmet medical need and attractive commercial potential. The key components of our strategy include the following:

  • Focus on developing novel, small molecule product candidates for the treatment of cancer;
  • Identify molecular, genetic or other tumor-related characteristics of patients more likely to benefit from our product candidates;
  • Leverage clinical and pathology trends towards comprehensive tumor profiling and the use of companion diagnostics;
  • Pursue opportunities to enhance clinical activity, minimize toxicity and address mechanisms of innate and adaptive resistance to standard of care therapies through rational combinations;
  • Build a sustainable product pipeline and advance our programs through a combination of internal discovery and development and external sources, including strategic partnerships, collaborations, in-licenses and acquisitions;
  • Maintain significant development and commercial rights to our product candidates; and
  • Invest in pre-commercial activities to maximize the value of our pipeline assets.

Precision Medicines in Cancer Treatment

Advancements in cancer genetics and new molecular diagnostic tools are helping define why some patients respond to a specific therapy while other patients receive little to no clinical benefit. This area of cancer drug discovery and development offers the potential for innovative treatments that are safer and more effective for patients with specific cancers. We aim to improve patient outcomes and contribute to the reduction in healthcare costs by matching targeted therapeutics to the patients who will derive the most benefit. We are developing a pipeline of small molecule product candidates designed to inhibit dysregulated proteins and/or abnormally functioning cellular pathways that drive cancer growth or drug resistance and, in general, intend to pair them with molecular diagnostics to identify those patients with tumors most likely to respond to treatment. This approach to treatment is known as precision medicine.

A pioneering example of a precision medicine in cancer was the development of small molecule inhibitors against EGFR in patients with advanced lung cancer. Patients with EGFR mutations treated with EGFR inhibitors have a response rate in the 65% range, as opposed to a response rate of approximately 10% in unselected lung patients. Erlotinib (Tarceva®) was approved in the United States as a first-line treatment for patients with NSCLC characterized by EGFR mutations. Other examples of approved agents developed using precision medicine approaches include ALK, BCR-ABL, BRAF, ROS1, RET, TRK, KRASG12C and PI3 kinase alpha inhibitors.

Precision medicine has several advantages over traditional drug development. We believe evidence-based selection of patients who are more likely to respond to a targeted therapy based on tumor biology provides the potential for: higher translatability from preclinical studies to clinical trials; increased overall response rates, requiring fewer enrolled patients for clinical development; expedited clinical development in areas of high unmet need and improved safety relative to less selective approaches and/or standard chemotherapy. We believe the precision medicine approach has the potential for more efficient drug development with reduced risks, costs and timelines. However, achieving success through a precision medicine approach is predicated on a thorough understanding of tumor biology and the mechanism of action of the product candidate. To develop this understanding, we have conducted extensive translational research on each of our programs.

Our Approach to Development of Precision Medicines in Oncology

Translational research is the practice of synthesizing our knowledge of basic research, preclinical and clinical data to develop a “bench-to-bedside” understanding of the potential of our product candidates, and it is the principal methodology we utilize to guide our precision medicine approach. We evaluate our product candidates through both in vitro and in vivo methodologies to characterize their potential as therapeutics using 2D and 3D proliferation and cytotoxicity assays, pharmacodynamic analyses such as western blotting, quantitative polymerase chain reaction, and RNA sequencing, and in vivo cell line-derived xenograft, or CDX, and patient-derived xenograft, or PDX, models. PDX models mostly retain the principal histologic and genetic characteristics of their donor tumor and have been shown in many instances to be predictive of clinical outcomes and are increasingly being used for preclinical drug evaluation, biomarker identification, biologic studies and personalized medicine strategies. We place an emphasis on preclinical PDX studies seeking to align our research results with clinical data and to identify and prioritize appropriate clinical indications for our product candidates.

Because we often target molecular and/or genetic alterations that are detectable, companion diagnostic tests can be developed to identify these alterations. Once we have identified a target, we will initially use existing diagnostic tools, such as molecular assays (next-generation sequencing, or NGS, and/or qualitative polymerase chain reaction of DNA and/or RNA), or tissue-based assays, such as protein expression by immunohistochemistry, to identify patient subsets that we believe will derive increased benefit from our product candidates. As we advance our product candidates clinically and determine the most important screening criteria, we intend to develop companion diagnostics as appropriate, with the help of technology partners, to seek to identify patients, and if our clinical development programs are successful, to support the potential registration and marketing of our product candidates.

Our clinical development strategy employs a disciplined approach designed to identify response signals early in development and reduce development risks. Based upon the data from our preclinical studies as well as clinical data, we seek to evaluate our product candidates in well-defined patient populations and believe this gives us a higher likelihood of demonstrating a clinical benefit. This approach is intended to allow for early insight into the therapeutic potential of a product candidate and the possibility for rapid clinical development and expedited regulatory strategies.

We are employing some or all of the steps above across our various programs as we advance our pipeline of targeted therapies. We believe the advantages of such an approach are the potential for higher translatability from preclinical studies to clinical trials, the ability to leverage clinical and pathology trends towards comprehensive tumor profiling and the potential for expedited clinical development.

Clinical Programs and Pipeline

Ziftomenib – A Selective Inhibitor of the Menin-KMT2A Interaction

Overview

Our lead product candidate, ziftomenib, is a potent, selective, reversible and oral small molecule inhibitor that blocks the interaction of two proteins, menin and the protein expressed by the Lysine K-specific Methyl Transferase 2A gene, or KMT2A gene (formerly referred to as the mixed-lineage leukemia 1, or MLL1, gene). We are developing ziftomenib for the treatment of genetically defined subsets of acute leukemias, including AML and ALL. We also are exploring therapeutic opportunities for ziftomenib in GIST, as well as other menin inhibitors in the treatment of type 2 diabetes and certain solid tumors.

Acute Leukemias and Genetic Alterations

Acute leukemias, including those with rearrangements or partial tandem duplications in the KMT2A gene as well as those with oncogenic driver mutations in genes such as nucleophosmin 1, or NPM1, are characterized by chromosomal translocations of the KMT2A gene that are primarily found in patients with AML and ALL and affect both children and adults. These translocations form oncogenes encoding KMT2A fusion proteins, which play a causative role in the onset, development and progression of KMT2A-rearranged leukemias. KMT2A fusion proteins drive the upregulation of expression of a small set of target genes involved in the malignant transformation of blood cells, however, the fusion protein is critically dependent on binding the oncogenic co-factor menin to function. This implies that the menin-KMT2A interaction represents a valuable target for molecular therapy and supports the development of inhibitors of the menin-KMT2A protein-protein interaction.

The target genes of the KMT2A fusion proteins are also found to be overexpressed in a broader subset of AMLs characterized by mutations in NPM1, DNA methyltransferase 3A, or DNMT3A, isocitrate dehydrogenase 1, or IDH1, isocitrate dehydrogenase 2, or IDH2, and a different mutation in the KMT2A gene, known as an KMT2A-partial tandem duplication. These mutations also appear to be dependent on the interaction between menin and KMT2A, suggesting that the menin-KMT2A complex is a central node in epigenetic dysregulation driven by multiple distinct oncogenic driver mutations known to be important in AML and other hematologic malignancies.

NPM1 mutations are among the most common genetic alterations, representing approximately 30% of AML. NPM1 mutations drive leukemogenesis in AML via cytoplasmic dislocation of NPM1 protein, resulting in transcription of disease-associated genes and inhibition of normal differentiation programs. NPM1-mutant AML is highly sensitive to disruption of the menin-KMT2A complex, which leads to decreased expression of essential leukemic genes, reduction of leukemic self-renewal capacity and promotion of differentiation. While patients with NPM1-mutant AML have high response rates to frontline therapy, relapse rates are high and survival outcomes are poor. Median overall survival, or OS, is only six months following relapse for NPM1-mutant patients. Currently, there are no therapies specifically indicated for NPM1-mutant AML that have been approved by the U.S. Food and Drug Administration, or the FDA.

KMT2A rearrangements represent approximately 5-10% of AML. Patients with KMT2A-rearranged AML have a poor prognosis with high rates of resistance and relapse following standard of care therapies. In the pediatric population, KMT2A-rearranged leukemias make up approximately 10% of acute leukemias. In the case of infant leukemias, the frequency of KMT2A rearrangements is 70–80%. These pediatric leukemia sub-types portend a poorer prognosis and five-year survival rate that is lower than other leukemia sub-types.

In adults, AML is the most common acute leukemia worldwide. Despite the many available treatments for AML, prognosis for patients remains poor. Up to 40% of patients with newly diagnosed AML do not achieve remission with standard induction chemotherapy, and up to 70% of patients with AML who achieve a complete remission, or CR, after induction therapy relapse.

AML patients who are determined to be able to tolerate intensive chemotherapy based on their health and fitness are most often treated with a combination of cytarabine and an anthracycline (e.g., daunorubicin, idarubicin) with a 7-day/3-day (7+3) dosing schedule. Patients who are deemed to be unfit for intensive induction, including most patients over age 75, are typically treated with less intensive systemic therapies, such as hypomethylating agents (e.g., azacitidine, decitabine) in combination with targeted or other therapies (e.g., venetoclax).

Hematopoietic cell transplantation, or HCT, is potentially the only curative option for AML. However, not all patients are eligible for HCT and, unfortunately, up to 40% of patients who undergo HCT relapse within five years. By preventing the interaction of menin and KMT2A/MLL, we believe ziftomenib has the potential to address up to 50% of AML cases, including NPM1-mutant AML and KMT2A-rearranged AML as well as other genetic subtypes that are dependent on the menin pathway.

Preclinical Data Supporting Ziftomenib as a Monotherapy and in Combination with Other Therapies for AML

We have generated preclinical data that support the potential anti-tumor activity of ziftomenib in genetically defined subsets of acute leukemia, including those with rearrangements or partial tandem duplications in the KMT2A gene as well as those with oncogenic driver mutations in genes such as NPM1. Our preclinical data support the hypothesis that ziftomenib targets epigenetic dysregulation and removes a key block to cellular differentiation to drive anti-tumor activity.

In November 2017, we reported preclinical data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics showing robust and durable activity in multiple in vivo models of AML characterized by KMT2A rearrangements or mutations in NPM1, DNMT3A, IDH1 and IDH2. We have further demonstrated that the inhibition of the menin-KMT2A interaction results in the down-regulation of KMT2A fusion target genes and an upregulation of markers of differentiation.

In December 2021, we reported preclinical data for ziftomenib and its potential for synergistic activity in combination with the BCL2 inhibitor venetoclax, a current standard of care in the treatment of patients with AML. These data confirm that treatment with ziftomenib drives dose-dependent induction of growth inhibition, differentiation and loss of viability of AML cells with KMT2A rearrangements or NPM1 mutations, while also reducing key protein levels such as myeloid ecotropic virus insertion site 1, or MEIS1, fms-like tyrosine kinase 3, or FLT3, and B-cell lymphoma 2, or BCL2, and menin itself. In addition, the findings demonstrated that co-treatment with ziftomenib and venetoclax induces synergistic activity in patient-derived AML cells expressing KMT2A rearrangements or NPM1 mutations, with or without mutant FLT3 expression, and prolongs survival in an aggressive disseminated model of KMT2A-rearranged, FLT3-mutant AML.

Clinical Development of Ziftomenib in AML

Ziftomenib as a Monotherapy in Relapsed/Refractory AML: KOMET-001 Trial

We received orphan drug designation for ziftomenib for the treatment of AML from the FDA in July 2019. In September 2019, we initiated the Kura Oncology MEnin-KMT2A Trial, or KOMET-001 trial, a global Phase 1/2 clinical trial of ziftomenib in patients with relapsed or refractory AML to investigate the safety and tolerability of ziftomenib in humans, determine a recommended Phase 2 dose, or RP2D, characterize pharmacokinetics of ziftomenib and assess any early evidence of clinical activity.

In December 2020, we announced preliminary results from our KOMET-001 trial at an oral presentation at the American Society of Hematology Annual Meeting, or ASH. As of the data cutoff date for the ASH presentation, November 2, 2020, the trial had enrolled 12 patients with relapsed or refractory AML, of whom ten were evaluable for safety and tolerability and eight were evaluable for efficacy. Clinical or biological activity was reported in six of the eight efficacy-evaluable patients, including two patients achieving a CR, one patient achieving a morphological leukemia-free state, and one patient experiencing a marked decrease in hydroxyurea requirements and having attained peripheral blood count stabilization. As presented at ASH, ziftomenib was well tolerated with a manageable safety profile. As of the data cutoff date, no drug discontinuations due to treatment-related adverse events and no evidence of QTc prolongation were reported. Treatment related adverse effects (Grade ≥ 3) were reported to include pancreatitis, increased lipase, decreased neutrophil count, tumor lysis syndrome and deep venous thrombosis.

In May 2021, we reported that we amended the KOMET-001 protocol to include two Phase 1b expansion cohorts at doses that cleared the safety threshold in dose escalation. The Phase 1b portion of the trial was designed to determine the lowest dose of ziftomenib that provides maximum biologic and clinical effect, consistent with guidance from the FDA relating to targeted oncology therapies, known as Project Optimus.

In June 2021, we reported that we dosed our first patient in the Phase 1b expansion cohorts. Each cohort – a lower dose (200 mg) and a higher dose (600 mg) – was comprised of NPM1-mutant and KMT2A-rearranged relapsed or refractory AML patients. Both doses demonstrated preliminary evidence of activity and safety and were determined to be well tolerated in the Phase 1a portion of the trial.

In November 2021, we reported that the FDA had placed the KOMET-001 trial on a partial clinical hold. The partial clinical hold was initiated following our report to the FDA of a Grade 5 serious adverse event potentially associated with differentiation syndrome, or DS, a known adverse event related to differentiating agents in the treatment of AML. Patients who were enrolled in the Phase 1b expansion cohort at the time of the partial clinical hold were permitted to continue to receive ziftomenib, although no additional patients were to be enrolled until the partial clinical hold was lifted. In January 2022, we announced that the FDA had lifted the partial clinical hold on the KOMET-001 trial following agreement on our mitigation strategy for DS and that the trial would resume screening and enrollment of new patients.

In August 2022, we announced that we completed enrollment in the Phase 1b expansion cohorts of the KOMET-001 trial.

In December 2022, we presented updated clinical data from the Phase 1a dose-escalation portion of the KOMET-001 trial at ASH. In the Phase 1a portion of the KOMET-001 trial, ziftomenib demonstrated a wide therapeutic window and encouraging monotherapy activity in an all-comer population of 30 patients with relapsed or refractory AML.

In June 2023, we presented updated clinical data from KOMET-001, including data from Phase 1b, during a late-breaking oral session at the 2023 European Hematology Association Annual Congress, or EHA, including durable activity in patients with heavily pretreated and co-mutated relapsed or refractory NPM1-mutant AML. A total of 53 patients were treated in the Phase 1b dose-validation and dose-expansion portions of the trial. Ziftomenib demonstrated optimal clinical benefit at 600 mg in the Phase 1b portion of the KOMET-001 trial and this dose was designated as the RP2D.

As of the data cutoff on April 12, 2023, seven of the 20 patients (35%) with NPM1-mutant AML treated at the RP2D of 600 mg achieved a CR with full count recovery. An eighth patient, who had a CR with partial count recovery after treatment with ziftomenib, subsequently evolved to a CR with full count recovery after HCT and remained on-study as of the date of the EHA presentation. In addition, a patient with NPM1-mutant AML treated at 200 mg remained on ziftomenib for 36 cycles as of the data cutoff.

Durable remissions were observed in patients with NPM1 mutations and other key co-mutations following treatment with ziftomenib. Notably, 33% (2/6) of patients with FLT3 co-mutations, 50% (4/8) of patients with isocitrate dehydrogenase, or IDH, co-mutations and 50% (2/4) of patients with both FLT3 and IDH co-mutations achieved a CR at the 600 mg dose of ziftomenib. Ziftomenib demonstrated an overall response rate, or ORR, of 45% in patients with NPM1-mutant AML treated at the 600 mg dose. The median duration of response, or DoR, for all NPM1-mutant patients treated at 200 mg or 600 mg in the Phase 1a/b portion of the trial was 8.2 months (95% CI: 1.0 to NE), with a median follow-up of 8.8 months. The median DoR for such patients censored at stem cell transplant was 5.6 months (95% CI: 1.0 to NE).

As part of an ongoing analysis, the resistance mutation MEN1-M327I was detected in three patients treated with ziftomenib: in two of these three patients, the mutation was detected at study entry after the patients had progressed on a prior menin inhibitor, and in the third patient, the mutation was detected after four cycles of ziftomenib therapy and, despite the mutation, the patient was maintained in a condition of stable disease through cycle 7. These data show that MEN1 mutations developed in just 3% (1/29) of patients analyzed following treatment with ziftomenib and suggest that resistance mutations occur at a low frequency even after prolonged exposure to ziftomenib monotherapy. A key new biochemical finding, confirmed by crystal structure, demonstrates that ziftomenib retains binding affinity against the MEN1-T349M mutation, which was detected in two-thirds of patients who acquired menin resistance mutations on another recent menin inhibitor trial.

Continuous daily dosing of ziftomenib was well tolerated and the reported adverse event profile remained consistent with features of underlying disease. The on-target effect of DS was manageable, with 15% of patients experiencing Grade 1 or 2 events and 5% experiencing a Grade 3 event.

In February 2023, we announced the dosing of the first patients in the Phase 2 registration-directed portion of the KOMET-001 trial, which is designed to assess clinical activity, safety and tolerability of ziftomenib in patients with relapsed or refractory NPM1-mutant AML. In May 2023, we amended the KOMET-001 protocol to include a sub-study of ziftomenib in patients with ALL, and two sub-studies of ziftomenib in patients with non-NPM1-mutant and non-KMT2A-rearranged AML. We dosed the first patients in the ALL and non-NPM1-mutant/non-KMT2A-rearranged AML sub-studies in the first quarter of 2024.

We completed enrollment of more than 85 patients in the Phase 2 portion of KOMET-001 in May 2024. On September 30, 2024, we announced the publication of our KOMET-001 Phase 1 study manuscript in The Lancet Oncology. The results of the Phase 1 trial, as reported in The Lancet Oncology, demonstrated promising clinical activity with manageable toxicity in heavily pretreated patients including marrow blast reduction, neutrophil and platelet recovery, transfusion independence, and clearance of measurable residual disease.

On February 5, 2025, we and Kyowa Kirin announced positive topline results from the Phase 2 registration-directed portion of KOMET-001. The KOMET-001 trial achieved its primary endpoint of CR plus CR with partial hematological recovery, or CRh. The results of the trial demonstrated an encouraging benefit-risk profile, and the safety and tolerability profile was consistent with prior reports. We expect to present topline data from the Phase 2 portion of KOMET-001 at an international medical meeting in the second quarter of 2025.

Ziftomenib Combinations with Standards of Care for AML

Ziftomenib in Combinations with Venetoclax/Azacitidine and 7+3: KOMET-007 Trial

In addition to evaluating ziftomenib as a monotherapy in the KOMET-001 trial, we have initiated a series of clinical trials to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations, including patients with NPM1-mutant and KMT2A-rearranged AML. The first of these trials, which we call KOMET-007, is designed to evaluate ziftomenib in combination with venetoclax and azacitidine in patients with newly diagnosed or relapsed or refractory NPM1-mutant or KMT2A-rearranged AML, and ziftomenib in combination with cytarabine and daunorubicin induction chemotherapy, or 7+3, in patients with newly diagnosed NPM1-mutant or KMT2A-rearranged AML. We initiated dosing of patients in KOMET-007 in the third quarter of 2023.

In January 2024, we announced preliminary data from the first 20 patients in the KOMET-007 trial. The first 20 patients were enrolled in KOMET-007 between July 2023 and November 2023, including five newly diagnosed patients with adverse risk NPM1-mutant or KMT2A-rearranged AML and 15 patients with relapsed or refractory NPM1-mutant or KMT2A-rearranged AML. Patients are considered “adverse risk” if they are at least 60 years old and/or have treatment-related AML and/or adverse risk cytogenetics per the criteria established by European LeukemiaNet.

Continuous daily dosing of ziftomenib at 200 mg was well tolerated and the safety profile was consistent with features of underlying disease and backbone therapies. No DS events of any grade were reported, and no dose-limiting toxicities, evidence of QTc prolongation, drug-drug interactions or additive myelosuppression were observed. As of the data cutoff on January 11, 2024, all newly diagnosed patients treated with ziftomenib and 7+3 achieved a CR with full count recovery, for a CR rate of 100% (5/5), including four patients with NPM1-mutant AML and one patient with KMT2A-rearranged AML. The ORR among relapsed or refractory patients treated with ziftomenib and venetoclax/azacitidine was 53% (8/15). Among all patients treated with ziftomenib and venetoclax/azacitidine, 40% (6/15) received prior treatment with a menin inhibitor. The rate of CRs or CRhs in patients who were menin inhibitor naïve was 56% (5/9), including 60% (3/5) in patients with NPM1-mutant AML and 50% (2/4) in patients with KMT2A-rearranged AML. The ORR in patients who received prior venetoclax was 40% (4/10), including 60% (3/5) in patients with NPM1-mutant AML. As of the data cutoff, 80% (16/20) of patients remained on trial, including 100% (11/11) of all NPM1-mutant patients.

We enrolled more than 100 patients in the Phase 1a dose escalation portion of the KOMET-007 trial, with all four cohorts clearing the highest dose of 600 mg once a day. In December 2024, we presented clinical data from the Phase 1a trial at ASH. In an oral session, we presented data from patients with newly diagnosed NPM1-mutant or KMT2A-rearranged adverse risk AML treated with ziftomenib in combination with 7+3, and in a poster session, we presented data from patients with relapsed or refractory NPM1-mutant or KMT2A-rearranged AML treated with ziftomenib in combination with venetoclax/azacitidine. Ziftomenib was generally well tolerated in combination at all dose levels evaluated across all cohorts in the Phase 1a dose-escalation portion of the trial. No dose-limiting toxicities, evidence of ziftomenib-associated QTc prolongation, drug-drug interactions or additive myelosuppression were observed. In the 7+3 combination cohorts, on-target DS occurred in 2% (1/51) of patients. Grade ≥3 treatment emergent adverse events, or TEAEs, occurring in ≥20% were febrile neutropenia, anemia and reductions in platelet count, neutropenia count and white blood cell count. In the venetoclax/azacitidine combination cohorts, on-target DS occurred in 8% (4/53) of patients. Grade ≥3 TEAEs occurring in ≥20% were platelet count reductions, anemia and febrile neutropenia. All instances of DS were manageable, and no patients discontinued participation due to DS.

Among the response-evaluable patients enrolled in the 7+3 combination cohort for patients with newly diagnosed NPM1-mutant or KMT2A-rearranged adverse risk AML, 91% (42/46) achieved a CR (100% for patients with NPM1-mutant AML, 83% for patients with KMT2A-rearranged AML). Minimum residual disease, or MRD, negativity was 76% in patients with NPM1-mutant AML and 75% in patients with KMT2A-rearranged AML. All patients with NPM1-mutant AML (24/24) and 96% (26/27) of patients with KMT2A-rearranged AML remained alive as of the data cutoff on October 1, 2024, with a median follow-up of 31 and 19 weeks, respectively.

A total of 54 patients were enrolled in the combination cohort with venetoclax/azacitidine in relapsed or refractory NPM1-mutant or KMT2A-rearranged AML. The NPM1-m population achieved an ORR of 68% (15/22) and a composite complete remission, or CRc, rate of 50% (11/22). In patients with NPM1-mutant AML who had previous venetoclax exposure, the ORR was 50% (7/14) and CRc was 36% (5/14). Thirty percent of patients with KMT2A-rearranged AML responded, including those with prior venetoclax exposure.

The Phase 1b expansion portion of KOMET-007 is now enrolling at 600 mg in all cohorts, including ziftomenib in combination with venetoclax/azacitidine in frontline non-intensive NPM1-mutant or KMT2A-rearranged AML and ziftomenib in combination with 7+3 in frontline intensive NPM1-mutant or KMT2A-rearranged AML, without the qualifications for adverse risk. Each cohort of the Phase 1b trial is expected to enroll at least 20 patients. We anticipate presenting preliminary data from the Phase 1b expansion portion of the KOMET-007 trial in frontline intensive AML in the second quarter of 2025 and preliminary data from the Phase 1b expansion portion of the KOMET-007 trial in frontline non-intensive AML in the second half of 2025.

Ziftomenib in Combinations with Gilteritinib, FLAG-IDA and LDAC: KOMET-008 Trial

The second ziftomenib combination trial, which we call KOMET-008, is designed to evaluate ziftomenib in combination with gilteritinib in patients with relapsed or refractory NPM1-mutant AML, and ziftomenib in combination with fludarabine, cytarabine, granulocyte-colony stimulating factor, or G-CSF, and idarubicin, or FLAG-IDA, or low-dose cytarabine, or LDAC, in patients with relapsed or refractory NPM1-mutant or KMT2A-rearranged AML. On February 26, 2024, we announced that we dosed the first patient in KOMET-008. Dosing of patients in all cohorts of the KOMET-008 trial is ongoing.

Ziftomenib in Combinations with Venetoclax/Azacitidine and 7+3 in Newly Diagnosed AML: KOMET-017 Trials

On February 5, 2025, following End-of-Phase 1 meetings with the FDA, we and Kyowa Kirin announced plans for KOMET-017, a global protocol evaluating ziftomenib in combination with standards of care for adults with newly diagnosed NPM1-mutant or KMT2A-rearranged AML. The KOMET-017 trial will be comprised of two independent, global, randomized, double-blind, placebo-controlled Phase 3 trials to evaluate ziftomenib in combination with both intensive and non-intensive regimens in patients with newly diagnosed NPM1-mutant or KMT2A-rearranged AML.

The End-of-Phase 1 meetings were intended to serve as the key regulatory interaction ahead of initiating the KOMET-017 protocol. In the meetings with the FDA, we confirmed that the breadth of the ziftomenib frontline AML development program is adequate in scope and reached alignment with the FDA on key aspects of the KOMET-017 protocol, including endpoints that provide pathways for both potential accelerated approval and full approval in the United States for both the intensive and non-intensive trials. In addition, we have gained alignment with the European Medicines Agency, or EMA, on key aspects of the KOMET-017 protocol.

The registrational KOMET-017-IC (Intensive Chemotherapy) trial will evaluate the combination of ziftomenib with induction chemotherapy (7+3) in patients with newly diagnosed NPM1-mutant or KMT2A-rearranged AML. Patients will be randomized to receive ziftomenib or placebo, in combination with standard induction, consolidation chemotherapy and post-consolidation maintenance. The KOMET-017-IC trial will assess MRD-negative CR and event-free survival, or EFS, as dual-primary endpoints to support potential U.S. accelerated approval and full approval, respectively. We expect to initiate the KOMET-017-IC trial in the second half of 2025. Based on our current assumptions, we believe we may have topline results from the MRD-negative CR accelerated endpoint in the intensive chemotherapy setting in 2028.

MRD is a term describing small numbers of leukemic cells that are still detectable during or after treatment, even when a patient has achieved CR by standard criteria. Remaining leukemia cells in the body can become active and start to multiply, resulting in a relapse of the disease, which may be fatal for patients. Achieving MRD negativity, which may be associated with longer remissions and improved survival, means that a treatment has reduced the number of leukemic cells to below the limit of detection by the most sensitive analytical methods.

The registrational KOMET-017-NIC (Non-Intensive Chemotherapy) trial will evaluate the combination of ziftomenib with venetoclax plus azacitidine in patients with newly diagnosed NPM1-mutant AML who are unfit to receive intensive chemotherapy. The KOMET-017-NIC trial will assess CR and OS as dual-primary endpoints to support potential U.S. accelerated approval and full approval, respectively. Patients will be randomized to receive ziftomenib or placebo, in combination with venetoclax and azacitidine. We expect to initiate the KOMET-017-NIC trial in the second half of 2025.

Registration Strategy for Ziftomenib in AML

In April 2024, the FDA granted ziftomenib Breakthrough Therapy Designation for the treatment of patients with relapsed or refractory NPM1-mutant AML based on data from the KOMET-001 clinical trial. Breakthrough Therapy Designation is granted for a drug that treats a serious or life-threatening condition and for which preliminary clinical evidence indicates the drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies. The designation is intended to expedite development and review of drugs, including an organizational commitment by FDA senior managers and experienced review staff as well as eligibility for rolling review and priority review.

Based upon the results of the KOMET-001 trial and our pre-NDA meeting with the FDA, we expect to submit a new drug application, or NDA, to the FDA for ziftomenib for the treatment of relapsed or refractory NPM1-mutant AML in the second quarter of 2025. We anticipate that the FDA will assign our NDA a Prescription Drug User Fee Act, or PDUFA, date in the second half of 2025.

Other Acute Leukemia Indications

As part of our KOMET-001 trial, we are evaluating ziftomenib in patients with ALL and patients with non-NPM1-mutant and non-KMT2A-rearranged AML.

We are supporting an investigator-sponsored trial, and may initiate a company-sponsored trial, evaluating the ability of ziftomenib to improve outcomes when administered as a maintenance therapy to patients with NPM1-mutant or KMT2A-rearranged AML following HCT.

Our clinical development plan also includes a pediatric development strategy. In December 2023, we announced a clinical collaboration with The Leukemia & Lymphoma Society, or LLS, to evaluate ziftomenib in combination with chemotherapy in pediatric patients with relapsed or refractory KMT2A-rearranged, NUP98-rearranged or NPM1-mutant acute leukemia. Under the terms of the collaboration agreement, LLS serves as the coordinating sponsor of a Phase 1 trial of ziftomenib in pediatric patients with acute leukemias in North America, the Princess Máxima Center for Pediatric Oncology in Utrecht, the Netherlands serves as the coordinating sponsor of the trial in Europe, and Kura supplies LLS and the Princess Máxima Center with ziftomenib for the trial.

Finally, several investigator-sponsored clinical trials of ziftomenib in acute leukemias are either open for enrollment or in development, in addition to the clinical trials described above.

Clinical Development of Ziftomenib in Gastrointestinal Stromal Tumors

GIST are the most common type of sarcoma in the gastrointestinal tract. Surgery is the primary treatment modality for GIST that has not metastasized. Most cases of GIST are driven by oncogenic mutations in the receptor tyrosine kinase KIT, and as a result, tyrosine kinase inhibitors, or TKIs, are used to treat GIST that cannot be surgically removed or to shrink tumors to facilitate their removal.

Imatinib is a TKI that is used to treat most patients with GIST. Although the majority of GIST patients achieve clinical benefit when treated with imatinib, up to 60% of patients will develop imatinib resistance within two years due to acquired secondary KIT mutations. TKIs such as sunitinib can target imatinib-resistant genotypes and are approved in later lines, but response rates and long-term clinical outcomes are modest. Our hypothesis is that menin inhibition may delay the onset of resistance to imatinib, or overcome resistance in patients pre-treated with imatinib and, in doing so, may shift the treatment paradigm in GIST.

In August 2024, we announced clearance by the FDA of an investigational new drug application, or IND, for ziftomenib for the treatment of advanced GIST in combination with imatinib. In October 2024, we presented preclinical data at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics that support the development of ziftomenib for the treatment of advanced GIST. Such data demonstrate robust and durable antitumor activity in imatinib-sensitive and

imatinib-resistant GIST PDX models treated with the combination of ziftomenib and imatinib. The antitumor activity in models treated with combination of ziftomenib and imatinib was superior to the antitumor activity in models treated with imatinib monotherapy. These data indicate a KIT-dependent mechanism, with ziftomenib and imatinib combining to reduce KIT expression and/or activity and drive the arrest and apoptosis of damaged cells. We expect to initiate a Phase 1 trial evaluating ziftomenib in combination with imatinib in patients with advanced GIST after imatinib failure, which we refer to as the KOMET-015 trial, in the first half of 2025.

Menin Inhibition in Diabetes

According to the Centers for Disease Control, or CDC, diabetes affects approximately 38.4 million people (11.6% of the population) in the United States. An additional 97.6 million people aged 18 years or older in the United States have prediabetes (representing 38.0% of the adult population). 1.2 million Americans are diagnosed with diabetes every year.

Type 1 diabetes, which is caused by autoimmune beta-cell destruction, usually leading to absolute insulin deficiency, including latent autoimmune diabetes of adulthood, accounts for 1.7 million diagnosed patients in the United States.

Diabetes represents a global epidemic. According to the CDC, more than 415 million people worldwide are afflicted with diabetes, and that number is expected to rise to more than half a billion people worldwide by 2040. Diabetes is one of the largest economic burdens on the U.S. health care system and the eighth leading cause of death in the United States. According to the American Diabetes Association, the total annual cost of diabetes in 2022 was reported to be $412.9 billion, including $306.6 billion in direct medical costs and $106.3 billion in indirect costs. People with diagnosed diabetes account for one of every four health care dollars spent in the United States.

A decline in beta-cell function and/or mass has been defined as a key contributing factor to disease progression in type 2 diabetes. Loss of functional beta cell mass is a core component of disease progression in both type 1 diabetes and type 2 diabetes. Beta cells are found in the pancreas and are responsible for the synthesis and secretion of insulin, a hormone that helps the body use glucose for energy and helps control blood glucose levels.

The primary treatment goal for diabetic patients is to achieve glycemic control by reducing HbA1c, a marker for the amount of sugar in the bloodstream, to 6.5% or lower. Glycemic control is a validated approach to delaying disease progression, which, if left unchecked, leads to significant and potentially fatal renal, cardiac, neurological, and ophthalmic comorbidities. Although multiple medications have been introduced for the treatment of type 2 diabetes, a large proportion of people do not achieve glycemic control, and there remains a significant need for new and improved therapeutic agents for the treatment and care of patients with diabetes.

Menin functions in a histone methyltransferase protein complex, and disruption of menin binding to its partner KMT2A in the complex leads to an increase in beta cell proliferation. Genetic menin loss, also known as multiple endocrine neoplasia type 1, or MEN1, syndrome, is associated with insulinemia due to upregulated pancreatic beta-cell proliferation. We believe that menin inhibition may impact insulin deficiency and insulin resistance by restoring beta-cell mass.

In June 2024, we presented preclinical data supporting the potential therapeutic utility of menin inhibitors in the treatment of diabetes at the American Diabetes Association’s 84th Scientific Sessions. In a preclinical in vivo model of type 2 diabetes, ziftomenib demonstrated consistent improvement in fasting blood glucose levels and insulin production and reduction of insulin resistance. The data demonstrated that the effects of ziftomenib were fully maintained following dose discontinuation, suggesting restoration of beta-cell mass. In addition, in human islet microtissues originating from two donor samples, ziftomenib induced beta-cell proliferation while non-beta-cell proliferation was not detectable, indicating that menin is a viable therapeutic target for beta-cell mass specific expansion.

We continue to make progress toward multiple next-generation menin inhibitor drug candidates. We expect to nominate the first of these development candidates, which we intend to direct towards diabetes, in mid-2025.

Farnesyl Transferase Inhibitors

Protein Farnesylation

Certain cellular proteins must associate with cell membranes to function. One of the mechanisms by which proteins are associated with cell membranes is farnesylation, which modifies the protein by attaching a farnesyl group and allows the farnesylated protein to remain closely associated with the cell membrane. Another, related mechanism of attachment of proteins to the membrane is protein geranylgeranylation, which is attachment of a geranylgeranyl group to the protein. Protein farnesylation and protein geranylgeranylation, collectively called protein prenylation, cause intracellular proteins to become anchored to cell membranes or other membrane-associated proteins due to the hydrophobic nature of the farnesyl and geranylgeranyl groups.

The enzyme that catalyzes the attachment of 15-carbon farnesyl groups to proteins is called farnesyl transferase, while geranylgeranyl transferase is the enzyme that catalyzes attachment of 20-carbon geranylgeranyl groups to proteins. Many proteins involved in cellular signaling, such as certain members of the Ras family of guanosine triphosphatases, undergo prenylation because they must be associated with other proteins on cell membranes to function properly.

Among the hundreds of proteins that can potentially be prenylated, some are either exclusively farnesylated or exclusively geranylgeranylated, some are both farnesylated and geranylgeranylated, and others are naturally farnesylated but become geranylgeranylated, when the farnesyl transferase enzyme is inhibited. HRAS is an example of a protein that is exclusively farnesylated while KRAS and NRAS are two proteins that are naturally farnesylated but may become geranylgeranylated upon treatment with FTIs. A recent report used state-of-the-art mass spectrometry-based methods to definitively identify the farnesylation-dependent ‘farnesylome’ in a single cell type and found that several dozen proteins were efficiently deprenylated by tipifarnib treatment, including the non-redundant mTOR regulator Ras Homolog Enriched in Brain, or RHEB, and the nuclear envelope components Lamins A, B1 and B2.

Farnesyl Transferase Inhibitors in HRAS-Mutant Cancers

The potential for FTIs to demonstrate enhanced clinical activity relative to standard of care is illustrated by the clinical activity of tipifarnib in solid tumors that are driven by activating mutations of the HRAS proto-oncogene. Mutations in the HRAS gene are initiating oncogenic events in human cancers, including head and neck cancers as well as salivary and urothelial carcinomas. Because HRAS is obligately farnesylated and cannot be geranylgeranylated, its membrane localization and cellular function can be suppressed by FTIs. As a result, HRAS-mutant tumors are sensitive to direct inhibition by FTIs, and FTIs have consistently shown high activity in HRAS-mutant tumor cell lines and in PDX animal models.

In addition, objective responses have been observed in patients with recurrent and metastatic HRAS-mutant head and neck cancers, salivary carcinomas, and urothelial carcinomas upon treatment with tipifarnib as a monotherapy. The activity of FTIs in HRAS-mutant tumors appears to be mediated by apoptosis, anti-angiogenesis, and direct effects on inhibiting cellular proliferation. HRAS mutations are prevalent in recurrent/metastatic HNSCC and are associated with poorer patient outcomes and lower treatment response rates to existing therapies.

We previously demonstrated that tipifarnib, a potent, selective and reversible inhibitor of farnesyl transferase, could drive objective responses in patients with recurrent and metastatic HRAS-mutant HNSCC, representing the first convincing demonstration of the therapeutic potential of an FTI for the treatment of cancer.

KO-2806- Next-Generation Farnesyl Transferase Inhibitor

Overview

Over the past several years, we have pioneered the development of FTIs in monotherapy contexts, including targeting HRAS-mutant, biomarker-driven patient populations with a high unmet need. Although FTIs have demonstrated clinical utility as monotherapy to treat certain cancers with high unmet need, our focus is on development of FTIs in combination with other targeted therapies in large solid tumor indications to enhance antitumor activity, prevent or delay emergence of resistance, and improve therapeutic outcomes for patients.

KO-2806 in Combination with Targeted Therapies

Our preclinical data is supportive of FTIs in combination with a growing number of targeted therapies, including EGFR inhibitors and PI3 kinase alpha inhibitors in HNSCC, TKIs in RCC, KRASG12C inhibitors in NSCLC, and both mutant and pan-selective KRAS inhibitors in NSCLC, colorectal and pancreatic cancers. Our next-generation FTI, KO-2806, was developed with these applications in mind, and was designed to improve upon the potency, pharmacokinetic and physicochemical properties relative to earlier FTI drug candidates.

We have delivered multiple presentations of preclinical data over the past few years that we believe support the development of FTIs such as KO-2806 in combination with targeted therapies.

In April 2023, we presented preclinical data at the American Association for Cancer Research Annual Meeting highlighting the potential use of FTIs in combination with two distinct classes of targeted therapies. The first of two posters revealed robust synergy between tipifarnib and the standard-of-care antiangiogenic TKI axitinib in cell- and PDX models of clear cell renal cell carcinoma, or ccRCC. The second poster reported regression of multiple models of KRAS inhibitor-resistant NSCLC by addition of tipifarnib to adagrasib or sotorasib.

In September 2023, we presented preclinical data in an oral session at the 5th RAS-Targeted Drug Development Summit supporting the development of KO-2806 in combination with KRASG12C inhibitors to drive tumor regressions and durable responses in KRASG12C-mutant NSCLC. KRASG12C inhibitors have previously been shown to activate receptor tyrosine kinase signaling, leading to ERK-RSK and/or mTOR-S6 pathway reactivation. Our preclinical data demonstrated that co-treatment of preclinical models of KRASG12C-mutant NSCLC with KO-2806 and adagrasib deepens signaling inhibition at multiple nodes, including the mitogen-activated protein kinase and mTOR pathways, while decreasing cell proliferation. In both CDX and PDX models originating from NSCLC tumors, the combination of KO-2806 with adagrasib induced tumor regressions. In addition, the CDX and PDX models demonstrated enhanced duration and depth of antitumor response compared to adagrasib as a single-agent therapy.

In October 2023, we presented preclinical data at the AACR-NCI-EORTC International Conference supporting the development of KO-2806 with targeted therapies, including TKIs, KRASG12C inhibitors and KRASG12D inhibitors. The first of three posters illustrated that KO-2806 potentiates the antitumor activity of cabozantinib in ccRCC models. The second poster illustrated that KO-2806 blocks oncogenic signaling at multiple nodes to enhance the antitumor activity of KRASG12C inhibitor adagrasib in KRASG12C NSCLC. The third poster illustrated that KO-2806 constrains compensatory signaling reactivation to deepen responses to KRASG12D inhibition.

In October 2024, we presented preclinical data at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics that we believe further demonstrate the potential of KO-2806 as a companion therapeutic to augment the antitumor activities of both KRAS mutant-selective and pan-RAS inhibitors. The first of two posters illustrated that the addition of KO-2806 to xenograft model tumors progressing on a KRASG12C mutant-specific inhibitor re-sensitized the tumors to the KRAS inhibitor, resulting in inhibition of tumor growth and mTOR signaling. In the second poster, we reported that KO-2806 re-sensitized relapsing colorectal xenograft tumors to pan-RAS inhibition by targeting the mTOR signaling pathway.

We believe these data support our rationale to combine KO-2806 with TKIs in RCC and with KRASG12C inhibitors in NSCLC.

KO-2806 in Advanced Solid Tumors: FIT-001 Trial

In January 2023, we announced the clearance by the FDA of our IND application for KO-2806 for the treatment of advanced solid tumors. We are now evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of KO-2806 when administered as a monotherapy and in combination with other targeted therapies in a Phase 1 first-in-human trial, which we call the FIT-001 trial. In October 2023, we announced that we dosed the first patient in the monotherapy portion of the FIT-001 trial. We identified the maximum tolerated dose for KO-2806 as a monotherapy in the second half of 2024. We expect to present preliminary data from the FIT-001 trial for KO-2806 as a monotherapy in the second half of 2025.

The FIT-001 trial includes multiple cohorts to evaluate KO-2806 in combination with other targeted therapies in large solid tumor indications, including cabozantinib in RCC and adagrasib in KRASG12C-mutated NSCLC. In March 2024, we announced that we dosed the first patient with KO-2806 in combination with cabozantinib in the RCC cohort of the trial. In August 2024, we announced that we dosed the first patient in the KRASG12C-mutated NSCLC cohort of the trial. Enrollment in the dose escalation portions of the RCC and NSCLC cohorts is ongoing. We expect to initiate one or more expansion cohorts for the combination of KO-2806 with cabozantinib in RCC in the first half of 2025, and to present preliminary data from the cabozantinib combination portion of the FIT-001 trial in the second half of 2025.

Tipifarnib – An Oral Farnesyl Transferase Inhibitor

Overview

Tipifarnib is a potent, selective and orally bioavailable FTI. We in-licensed tipifarnib from Janssen Pharmaceutica NV, or Janssen, an affiliate of Johnson & Johnson, in December 2014. Previously, tipifarnib was studied in more than 5,000 oncology patients in more than 70 clinical trials and was observed to be generally well tolerated with a manageable side effect profile as a single agent. Although tipifarnib has a well-established safety profile and has demonstrated compelling and durable anti-cancer activity in certain patients, its activity has not been sufficient in any prior clinical trial to support marketing approval by the FDA. However, clinical and preclinical data suggest that, in certain selected patient populations, tipifarnib has the potential to provide significant benefit to cancer patients with limited treatment options. We have worldwide rights to tipifarnib in all indications other than virology.

Tipifarnib as a Monotherapy

In February 2021, the FDA granted tipifarnib Breakthrough Therapy Designation for the treatment of patients with recurrent or metastatic HRAS mutant HNSCC with variant allele frequency ≥ 20% after disease progression on platinum-based chemotherapy, or high VAF.

We conducted a global Phase 2, multi-center, open-label, non-comparative registration-directed clinical trial of tipifarnib in patients with recurrent/metastatic, or R/M, HRAS mutant HNSCC, which we called AIM-HN. On October 21, 2023, we presented the results of the AIM-HN trial in a late-breaking oral session at the 2023 European Society for Medical Oncology Congress. As of the data cutoff on June 15, 2023, 59 patients with R/M HRAS mutant HNSCC were enrolled in the AIM-HN trial, of whom 50 had high VAF and 38 were evaluable for efficacy. Responses were assessed by the investigators and an independent review facility, or IRF, in the modified intent to treat high VAF population. Both assessments by investigators and IRF observed one patient achieving a CR on treatment. Patients had a median of two prior lines of therapy (range 0-6) in the R/M setting and robust activity was seen in second line treatment and beyond with greater activity observed in the second line versus the third line and subsequent treatments. The ORR in second line treatment was 29% [0.13, 0.51] in the IRF assessment. The ORR for three FDA-approved therapies for the treatment of HNSCC in the second line range from 13-16%. Tipifarnib was generally well-tolerated with a manageable safety profile. The most common Grade 3 or 4 treatment-related adverse events, or TRAEs, seen in at least 10% of patients were cytopenias and TRAEs led to discontinuation of treatment in 7% of patients. We believe the positive results from AIM-HN validate the therapeutic value of farnesyl transferase inhibition.

While the AIM-HN trial generated compelling clinical data, in an ongoing effort to prioritize those programs with the highest potential to create value for patients, health care providers and shareholders, we have discontinued development of tipifarnib as a monotherapy.

Tipifarnib in Combination with Alpelisib in HNSCC: KURRENT-HN Trial

In July 2021, we announced a clinical collaboration with Novartis Pharma AG, or Novartis, to evaluate the combination of tipifarnib and alpelisib, a PI3 kinase alpha inhibitor, in patients with HNSCC whose tumors have HRAS overexpression and/or PIK3CA mutation and/or amplification. The collaboration is further described under the heading “License Agreements and Strategic Collaborations – Novartis” below. In the fourth quarter of 2021, we commenced a Phase 1/2 open-label, biomarker-defined cohort trial, which we call the KURRENT-HN trial, to evaluate the safety and tolerability of the combination, determine the recommended dose and schedule for the combination, and assess early antitumor activity of the combination for the treatment of such patients. In December 2021, we announced dose administration for the first patient in the PIK3CA cohort in KURRENT-HN.

In October 2022, we reported the first demonstration that the combination of tipifarnib and alpelisib can induce a durable clinical response in PIK3CA-dependent HNSCC at the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium. Our presentation highlighted a patient with stage III squamous cell carcinoma of the tonsil with a PIK3CA mutation who had achieved a durable partial response in the KURRENT-HN trial and continued on-study for more than 27 weeks as of the September 14th data cutoff. Since that presentation, we have continued dose escalation and have observed evidence of clinical activity at multiple doses. TRAEs in KURRENT-HN are consistent with the known safety profiles of each drug and are mostly low-grade and manageable with appropriate standard of care treatment. We have completed enrollment and dose escalation, and are in the process of confirming the optimal biologically active dose for the combination. We continue to evaluate whether the activity supports the development and commercialization of the combination in HNSCC. We anticipate presenting data from the KURRENT-HN trial in the second half of 2025, contemporaneous with our presentation of both monotherapy data for KO-2806 as well as data on the combination of KO-2806 and cabozantinib in RCC.

License Agreements and Strategic Collaborations

The University of Michigan

In December 2014, we entered into a license agreement with the University of Michigan, which was amended in March 2015, July 2015, September 2016, February 2017, May 2017 and August 2017, that grants us exclusive worldwide rights under certain patent rights to compounds in our menin-KMT2A program. Under this license agreement, we paid the University of Michigan an upfront nonrefundable license fee and are obligated to pay the University of Michigan annual license maintenance fees. We are also required to make development and regulatory milestone payments to the University of Michigan of up to $3.4 million in the aggregate if specified development and regulatory events are achieved for the first indication and additional payments for each subsequent indication. We are required to pay the University of Michigan a percentage of certain amounts received from any sublicenses granted under the license from the University of Michigan, and are paying the University of Michigan such a percentage in connection with the Kyowa Agreement, as defined below. When and if commercial sales of products covered by the licensed patent rights begin, we are obligated to pay the University of Michigan tiered royalties of low single digit percentages of our net sales depending on the amount of our net sales with standard provision for royalty offsets and sales-based milestones. As between us and the University of Michigan, all future development, regulatory and commercial work on the licensed compounds will be completed fully by us and at our sole expense. The University of Michigan retains the right to use the licensed compounds for non-commercial research, internal and/or educational purposes, with the right to grant the same limited rights to other non-profit research institutions. Under the agreement, as a result of our March 2015 private placement, we issued to the University of Michigan 79,113 shares of our common stock at a fair value of $0.5 million. The license agreement with the University of Michigan will terminate upon the last-to-expire patent rights, or may be terminated by us at any time with 90 days written notice of termination or terminated by the University of Michigan upon a bankruptcy by us, payment failure by us that is not cured within 30 days or a material breach of the agreement by us that is not cured within 60 days.

Kyowa Kirin

In November 2024, we entered into a collaboration and license agreement with Kyowa Kirin, or the Kyowa Agreement, to develop and commercialize ziftomenib for the treatment of patients with AML and other hematologic malignancies, or the Field, which may be expanded into other indications at the option of Kyowa Kirin, subject to certain conditions.

Under the terms of the Kyowa Agreement, in the United States, we will lead development, regulatory and commercial strategy and be responsible for manufacturing ziftomenib, and the companies will jointly perform commercialization activities in accordance with a co-created U.S. territory commercialization plan. Following regulatory approval, we will book sales of ziftomenib and the parties will share equally the profits and losses from the commercialization activities in the United States.

Outside the United States, Kyowa Kirin will lead development, regulatory and commercial strategy and will be responsible for commercializing ziftomenib and booking sales.

The companies will share responsibility for the conduct of clinical trials delineated within an agreed-upon development plan designed to support regulatory approval in the United States, or the Development Plan. The Kyowa Agreement includes plans to launch multiple Phase 2 and Phase 3 clinical trials of ziftomenib in AML and other hematologic malignancies over the next several years. Development and commercialization activities under the collaboration will be managed through a shared governance structure.

Under the Kyowa Agreement, Kyowa Kirin has an option to participate in the development and commercialization of ziftomenib in GIST and other solid tumor indications after receipt of clinical data from our KOMET-015 trial. If Kyowa Kirin exercises this option, the parties’ roles and responsibilities will follow the same structure as the collaboration in the Field.

Excluded from the collaboration are our ongoing efforts to advance multiple, next-generation menin inhibitor drug candidates targeting certain oncology indications, as well as diabetes and other metabolic diseases.

We received an upfront payment of $330.0 million and we expect to receive up to $420.0 million in near-term milestone payments, including upon the commercial launch of ziftomenib as a monotherapy in adult patients with relapsed or refractory NPM1-mutant AML. We are eligible to receive up to an aggregate of $1.161 billion in development, regulatory and commercial milestone payments for the existing Field and the expanded Field, together with the upfront payment for the expanded Field, totaling up to $1.491 billion in upfront and milestone payments in the aggregate. We also are eligible to receive tiered double-digit royalties on net product sales outside the United States.

Under the Development Plan, we will fund the specified development activities that are planned to be conducted prior to the end of 2028, and both companies will share equally (50/50) all development costs for all other development activities in the United States included in the Development Plan, including the costs of future trials in the United States.

The Kyowa Agreement will remain in effect in the United States until the latest of expiration of all valid claims of our patent rights licensed to Kyowa Kirin, expiration of the last-to-expire regulatory exclusivity or ten years after first commercial sale. The Kyowa Agreement will remain in effect outside the United States until the expiration of the last-to-expire royalty term. Either party may terminate the Kyowa Agreement for uncured material breach by or insolvency of the other party. Kyowa Kirin may terminate the Kyowa Agreement for convenience upon 12 months’ prior written notice. In addition, Kyowa Kirin has the right to terminate the Kyowa Agreement with a shorter specified notice period upon the occurrence of a material adverse regulatory event or certain other specified events. We may terminate the Kyowa Agreement if Kyowa Kirin or any of its affiliates or sublicensees challenges the validity or enforceability of any of the patent rights licensed to Kyowa Kirin by us.

Janssen Pharmaceutica NV

In December 2014, we entered into a license agreement with Janssen, which was amended in June 2016 that grants us exclusive global rights to develop and commercialize tipifarnib in all indications other than virology and includes the right to grant sublicenses. We are obligated under the license agreement to use commercially reasonable efforts to develop and commercialize tipifarnib and, with the exception of the transfer to us without cost of Janssen’s existing inventory of tipifarnib material, we are responsible for all future development and commercialization costs for tipifarnib.

Under the terms of the license agreement, in January 2015 we issued a convertible promissory note in the principal amount of $1.0 million to Johnson & Johnson Innovation—JJDC, Inc., which automatically converted into shares of common stock in our March 2015 private placement. When and if commercial sales of tipifarnib begin, we are obligated to pay Janssen tiered royalties of low teens percentages of our net sales, depending on the amount of our net sales, with standard provisions for royalty offsets in the event of generic competition or compulsory licenses, on a product-by-product and country-by-country basis until the later of the expiration of the last to expire valid claim of the licensed patents covering the licensed product in the field in such country, the expiration of any regulatory exclusivity with respect to such product in such country, and ten years from our first commercial sale. We are also required to make regulatory milestone payments to Janssen of up to $25.0 million in the aggregate, if specified regulatory approvals are achieved for the first indication and additional payments for each subsequent indication if specified regulatory approvals are achieved. In addition, we are required to make sales milestone payments of up to $50.0 million in the aggregate if specified sales thresholds are surpassed. If we grant sublicenses under the license from Janssen, we are required to pay to Janssen a percentage of any upfront, lump-sum or milestone payments received from our sublicensee, subject to certain exclusions for regulatory milestone payments due under the license agreement.

The license agreement with Janssen will remain in effect until the expiration of all of our royalty and sublicense revenue obligations to Janssen, determined on a product-by-product and country-by-country basis, unless we elect to terminate the license agreement earlier. If we fail to meet our obligations under the license agreement and are unable to cure such failure within specified time periods, Janssen can terminate the license agreement, resulting in a loss of our licensed rights to tipifarnib.

Mirati/BMS

In November 2023, we announced a clinical collaboration with Mirati Therapeutics, Inc., or Mirati, a wholly owned subsidiary of Bristol Myers Squibb, or BMS, as of January 2024, to evaluate the combination of KO-2806 and adagrasib, a KRASG12C inhibitor, in patients with NSCLC whose tumors have a KRASG12C mutation. Under the terms of the agreement, Mirati (now a Bristol Myers Squibb company) supplies us with adagrasib for the NSCLC combination cohort of the FIT-001 trial, and we sponsor the trial.

Novartis

In July 2021, we announced a clinical collaboration with Novartis to evaluate the combination of tipifarnib and alpelisib, a PI3 kinase alpha inhibitor, in patients with HNSCC whose tumors have HRAS overexpression and/or PIK3CA mutation and/or amplification. Under the terms of our collaboration agreement with Novartis, we sponsor the KURRENT-HN trial and supply tipifarnib, and Novartis supplies alpelisib for the trial.

Competition

The development and commercialization of new products to treat cancer is intensely competitive and subject to rapid and significant technological change. Although we believe that our knowledge, experience and scientific resources provide us with competitive advantages, we face substantial competition from major pharmaceutical companies, specialty pharmaceutical companies, and biotechnology companies worldwide. Many of our competitors have significantly greater financial, technical and human resources. Smaller and early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. As a result, our competitors may discover, develop, license or commercialize products before or more successfully than we do.

We face competition with respect to our current product candidates, and we will face competition with respect to future product candidates, from segments of the pharmaceutical, biotechnology and other related markets that pursue approaches to targeting molecular alterations and signaling pathways associated with cancer. Our competitors may obtain regulatory approval of their products more rapidly than we do or may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize our product candidates. Our competitors may also develop drugs that are more effective, more convenient, less costly or possessing better safety profiles than our products, and these competitors may be more successful than us in manufacturing and marketing their products.

In addition, in general, we will need to develop our product candidates in collaboration with diagnostic companies and will face competition from other companies in establishing these collaborations. Our competitors will also compete with us in recruiting and retaining qualified scientific, management and commercial personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

Furthermore, we also face competition more broadly across the market for cost-effective and reimbursable cancer treatments. The most common methods of treating patients with cancer are surgery, radiation and drug therapy, including chemotherapy, hormone therapy and targeted drug therapy or a combination of such methods. There are a variety of available drug therapies marketed for cancer. In many cases, these drugs are administered in combination to enhance efficacy. While our product candidates, if any are approved, may compete with these existing drug and other therapies, to the extent they are ultimately used in combination with or as an adjunct to these therapies, our product candidates may not be competitive with them. Some of these drugs are branded and subject to patent protection, and others are available on a generic basis. Insurers and other third-party payors may also encourage the use of generic products or specific branded products. We expect that if our product candidates are approved, they will be priced at a premium over competitive generic, including branded generic, products. As a result, obtaining market acceptance of, and gaining significant share of the market for, any of our product candidates that we successfully introduce to the market will pose challenges. In addition, many companies are developing new therapeutics, and we cannot predict what the standard of care will be as our product candidates progress through clinical development.

Menin Inhibitor Competition

We are aware of other companies with competing commercial or clinical-stage menin inhibitor programs, including Syndax, Biomea Fusion, Janssen, Sumitomo Dainippon and Lomond. If ziftomenib or our other product candidates do not offer sustainable advantages over competing products, we may not be able to successfully compete against current and future competitors.

Even if we are successful in developing our product candidates, the resulting products would compete with a variety of established drugs in each targeted therapeutic indication. There are several therapies approved for the treatment of AML, including Abbvie’s/Genentech’s venetoclax (VENCLEXTA®), Novartis’s midostaurin (RYDAPT®), Astellas’s gilteritinib (XOSPATA®), BMS’s enasidenib (IDHIFA®), Servier’s ivosidenib (TIBSOVO®), Rigel’s olutasidenib (REZLIDHIA®) and Daiichi-Sankyo’s quizartinib (VANFLYTA®).

FTI Competition

Although there are currently no approved drugs targeting farnesyl transferase for the treatment of cancer, we are aware of several compounds that are now or have previously been in clinical development, including Merck’s lonafarnib, BMS’s BMS-214662, Astellas Pharma’s, formerly OSI Pharmaceuticals, CP-609,754, and AstraZeneca’s AZD3409. To our knowledge, there are no ongoing clinical trials evaluating any of these agents for the treatment of cancer. However, the initiation of clinical development of another farnesyl transferase inhibitor in an oncology setting could become competitively significant, and if KO-2806, tipifarnib or our other product candidates do not offer sustainable advantages over competing products, we may not be able to successfully compete against current and future competitors.

Even if we are successful in developing our product candidates, the resulting products would compete with a variety of established drugs in each targeted therapeutic indication. There are several therapies approved for the treatment of NSCLC, including BMS’s nivolumab (Opdivo®) and ipilimumab (Yervoy®), Merck’s pembrolizumab (Keytruda®), AstraZeneca’s durvalumab (Imfinzi®), Roche’s atezolizumab (Tencentriq®), Regeneron’s cemiplimab-rwlc (Libtayo®), Amgen’s sotorasib (Lumakras®) and Mirati’s/BMS’s adagrasib (Krazati®); RCC, including Keytruda®, Opdivo®, Yervoy®, Exelixis’s cabozantinib (Cabomeyx®), Merck’s axitinib (Inlyta®) and Eisai’s lenvatinib (Lenvima®); and HNSCC, including Opdivo®, Keytruda® and Eli Lilly’s/Merck KGaA’s cetuximab (Erbitux®).

Commercialization

In preparation for potential FDA approval of ziftomenib in patients with relapsed or refractory NPM1-mutant AML, we have established a commercial department headed by a leadership team with expertise in launching pharmaceutical products for oncology indications. Our goals for our commercial department include developing initiatives with respect to market development or commercialization for any approved products. In furtherance of such goals, we are continuing to build out our commercial capabilities and infrastructure.

Under the Kyowa Agreement, as described in greater detail under the heading “License Agreements and Strategic Collaborations – Kyowa Kirin,” we will lead commercial strategy for ziftomenib and, jointly with Kyowa Kirin, perform commercialization activities in the United States. Subject to FDA approval, we expect to commence commercialization activities through a focused commercial team that would include marketing, analytics, market access and sales to sell our products in the United States.

Outside of the United States, Kyowa Kirin will lead commercial strategy and be responsible for commercializing ziftomenib.

With respect to the commercialization of ziftomenib in indications outside the Kyowa Agreement and our other product candidates, we anticipate that we will aim to retain commercial rights in North America, subject to receiving marketing approvals. If and when appropriate, we expect to commence commercialization activities through a focused internal commercial team that would include marketing, analytics, market access and a specialized, internal sales force in North America. We also may seek to retain commercial rights in Europe for ziftomenib in indications outside the Kyowa Agreement and our other product candidates for which we may in the future receive marketing approvals, and we may build a focused commercial team in Europe to sell such products. Outside of regions where we maintain commercial rights, we may enter into distribution and other marketing arrangements with third parties for any of our product candidates that obtain marketing approval in foreign jurisdictions.

We expect that any third parties with which we collaborate on the development of any commercial companion diagnostics for use with our therapeutic products will most likely hold the commercial rights to those diagnostic products.

Manufacturing

We do not own or operate, and currently have no plans to establish, any manufacturing facilities. We currently rely, and expect to continue to rely, on third parties for the manufacture of our product candidates for preclinical and clinical testing as well as for commercial manufacture of any products that we may commercialize. All of our product candidates are small molecules and are manufactured in synthetic processes from available starting materials. The chemistry does not currently require unusual equipment in the manufacturing process. We expect to continue to develop product candidates that can be produced cost-effectively at contract manufacturing facilities.

For all our product candidates, we aim to identify and qualify manufacturers to provide the active pharmaceutical ingredient, or API, and drug product services prior to submission of an NDA to the FDA.

We generally expect to rely on third parties for the development and manufacture of companion diagnostics to identify patient populations suitable for our product candidates.

We monitor and manage our supply chain network for potential changes that could impact our global or regulatory manufacturing supply strategy. We regularly review with our third-party manufacturers and supply chain suppliers their business continuity initiatives and programs.

Under the Kyowa Agreement, we have the exclusive right to manufacture ziftomenib for development and commercialization in the United States, and the co-exclusive right (with Kyowa Kirin) to manufacture ziftomenib for commercialization in leukemia outside of the United States. We will be responsible for the manufacture and supply of ziftomenib for development and commercialization globally, pursuant to the terms of a supply agreement to be negotiated by the parties. Kyowa Kirin has the right to request that we conduct a manufacturing technology transfer and to take over the responsibility of commercial supply of ziftomenib outside the United States.

Intellectual Property

Our commercial success depends in part on our ability to obtain and maintain proprietary or intellectual property protection for our product candidates and our core technologies, including novel biomarker and diagnostic discoveries and other know-how, to operate without infringing on the proprietary rights of others and to prevent others from infringing our proprietary or intellectual property rights. We expect that we will seek to protect our proprietary and intellectual property position by, among other methods, licensing or filing our own U.S., international and foreign patent applications related to our proprietary technology, inventions and improvements that are important to the development and implementation of our business. We also rely on trade secrets, trademarks, know-how and continuing technological innovation to develop and maintain our proprietary and intellectual property position, which we generally seek to protect through, for example, trademark applications and registrations, internal trade secret and confidentiality policies, and contractual obligations with third parties.

We currently, and expect that we will continue to, file or license patent applications directed to our key product candidates in an effort to establish intellectual property positions regarding composition-of-matter of these product candidates, as well as biomarkers that may be useful in selecting the right patient population for use of any of our product candidates, formulations, processes and methods of using these product candidates in the treatment of various cancers. We own or in-licensed patents or patent applications into our patent portfolio, which now includes issued U.S. and foreign patents, and pending patent applications in the United States, under the Patent Cooperation Treaty and in a number of foreign jurisdictions.

We have exclusively licensed from the University of Michigan and/or co-own multiple families of patent applications pertaining to our menin-KMT2A program. The U.S. Patent and Trademark Office, or U.S. PTO, has issued the University of Michigan and us patents covering the composition of matter of ziftomenib and certain structurally related compounds, and methods of using the compounds for the treatment of cancers, and related patents have been granted in foreign jurisdictions such as Europe, China, and Japan. We have obtained granted patents in the United States and China to other methods of use for ziftomenib, and we have filed and will continue to file additional U.S., international and foreign patent applications related to various aspects of ziftomenib development.

We have secured several U.S. and foreign method of treatment patents specifically directed to tipifarnib, as well as several U.S. and foreign patents pertaining to methods of treatment for FTIs more broadly. We have also exclusively licensed from Memorial Sloan Kettering Cancer Center a patent family pertaining to a method of use of tipifarnib, in which the U.S. PTO issued a patent. We currently, and expect that we will continue to, file for patents related to our FTI program in the United States with counterparts in Europe and other key markets in the rest of the world.

In addition to the patent applications that we have filed to date, we plan to continue to expand our patent portfolio by filing patent applications directed to inventions that arise from our research and development programs, including dosage forms, methods of treatment and additional compounds that inhibit our oncology molecular targets. Specifically, we have filed patent applications and we anticipate that we will continue to seek patent protection in the United States and internationally for novel compositions of matter covering the compounds, the chemistries and processes for manufacturing these compounds, their intermediates and/or metabolites, the use of these compounds in a variety of therapies and the use of biomarkers for patient selection for these compounds. However, these or other patent applications that we may file or license from third parties may not result in the issuance of patents, and any issued patents may include claims that may be of limited scope and/or may be challenged, invalidated or circumvented. See “Risk Factors—Risks Related to Our Intellectual Property.”

In addition to patents, we also 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 internal trade secret policies, confidentiality agreements with our collaborators, scientific advisors, employees and consultants, and invention assignment agreements with our employees and selected consultants, scientific advisors and collaborators. The confidentiality agreements are designed to protect our proprietary information and, in the case of agreements or clauses requiring invention assignment, to grant us ownership of technologies that are developed through a relationship with a third party.

Orange Book Listing

In seeking approval for a drug through an NDA, applicants are required to list with the FDA certain patents whose claims cover the applicant’s product. Upon approval, 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, commonly known as the Orange Book. Any applicant who files an abbreviated new drug application, or ANDA, seeking approval of a generic equivalent version of a drug listed in the Orange Book or a Section 505(b)(2) NDA referencing a drug listed in the Orange Book 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 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. This last certification is known as a paragraph IV certification. A notice of the paragraph IV certification must be provided to each owner of the patent that is the subject of the certification and to the holder of the approved NDA to which the ANDA or Section 505(b)(2) application refers. The applicant may also elect to submit a “section viii” statement certifying that its proposed label does not contain, or carves out, any language regarding the patented method-of-use rather than certify to a listed method-of-use patent.

If the NDA holder for the reference drug and/or patent owners assert a patent challenge directed to one of the Orange Book listed patents within 45 days of the receipt of the paragraph IV certification notice, the FDA is prohibited from approving the ANDA until the earlier of 30 months from the receipt of the paragraph IV certification, expiration of the patent, settlement of the lawsuit or a decision in the infringement case that is favorable to the applicant. The ANDA or Section 505(b)(2) application also will not be approved until any applicable non-patent exclusivity listed in the Orange Book for the reference drug has expired as described in further detail below.

Regulatory Exclusivity

In the United States, in addition to patent exclusivity, the holder of an NDA for a listed drug may be entitled to a period of non-patent exclusivity, during which the FDA cannot approve an ANDA or Section 505(b)(2) application that relies on the listed drug. For example, a pharmaceutical manufacturer may obtain five years of non-patent exclusivity upon FDA approval of a new chemical entity, or NCE, which is a drug that contains an active moiety that has not been approved by the FDA in any other NDA. An “active moiety” is defined as the molecule or ion responsible for the drug substance’s physiological or pharmacologic action. During the five-year exclusivity period, the FDA cannot accept for filing any ANDA seeking approval of a generic version of that drug or any Section 505(b)(2) NDA for the same active moiety and that relies on the FDA’s findings regarding that drug, except that the FDA may accept an application for filing after four years if the follow-on applicant makes a paragraph IV certification. Five-year NCE exclusivity does not block the submission, review or approval of a 505(b)(1) NDA.

Patent Term Extension

After NDA approval, owners of relevant drug patents may apply for up to a five-year patent extension for one U.S. patent. The allowable patent term extension is calculated as up to half of the drug’s testing phase—the time between IND effective date and NDA submission—plus all of the review phase—the time between NDA submission and approval, up to a maximum of five years. The time can be shortened if the FDA determines that the applicant did not pursue approval with due diligence. The total patent term, including the extension, may not exceed 14 years from the date of NDA approval.

For U.S. patents that might expire during the application phase, the patent owner may request an interim patent extension. An interim patent extension increases the patent term by one year and may be renewed up to four times. For each interim patent extension granted, the post-approval patent extension is reduced by one year. The director of the U.S. PTO must determine that approval of the drug covered by the patent for which a patent extension is being sought is likely. Interim patent extensions are not available for a drug for which an NDA has not been submitted.

Trademarks/Domain Names

Our intellectual property portfolio also includes various registered and allowed U.S. and foreign trademarks and pending U.S. and foreign trademark applications for the company as well as our product candidates. Trademark protection varies throughout the world and typically extends beyond the term of patent protection for a product. We own U.S. trademark registrations for KURA ONCOLOGY as well as foreign trademark registrations for KURA ONCOLOGY and trademarks associated with product candidates. Worldwide, we consider these trademarks in the aggregate to be of material importance to the operation of our business.

Government Regulation

FDA Approval Process

In the United States, pharmaceutical products are subject to extensive regulation by the FDA. The Federal Food, Drug and Cosmetic Act and other federal and state statutes and regulations govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling and import and export of pharmaceutical products. Failure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending NDAs, warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties and criminal prosecution.

Pharmaceutical product development for a new product or certain changes to an approved product in the United States typically involves preclinical laboratory and animal tests, the submission to the FDA of an IND which must become effective before clinical testing may commence, and adequate and well-controlled clinical trials to establish the safety and effectiveness of the drug for each indication for which FDA approval is sought. Product development is also guided by The International Council for Harmonisation, or ICH, a global initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. Regional and country-specific health authorities such as the FDA, the EMA, and Japan’s Pharmaceuticals and Medical Devices Agency, or PMDA, have adopted the ICH guidance as standards to be used in product development.

Preclinical tests include laboratory evaluation of product chemistry, formulation and toxicity, as well as animal trials to assess the characteristics and potential safety and efficacy of the product. The conduct of the preclinical tests must comply with federal regulations and requirements, including good laboratory practices. The results of preclinical testing are submitted to the FDA as part of an IND along with other information, including information about product chemistry, manufacturing and controls, and a proposed clinical trial protocol. Long-term preclinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND is submitted.

A 30-day waiting period after the submission of each IND is required prior to the commencement of clinical testing in humans. If the FDA has not placed the IND on hold within this 30-day period, the clinical trial proposed in the IND may begin.

Clinical trials involve the administration of the investigational new drug to healthy volunteers or patients under the supervision of a qualified investigator. Clinical trials must be conducted: (i) in compliance with federal regulations; (ii) in compliance with good clinical practice, or GCP, an international standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators and monitors; and (iii) under protocols detailing the objectives of the clinical trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. Each protocol involving testing on U.S. patients and subsequent protocol amendments must be submitted to the FDA as part of the IND.

The FDA may order the temporary, or permanent, discontinuation of a clinical trial at any time, or impose other sanctions, if it believes that the clinical trial either is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial patients. The trial protocol and informed consent information for patients in clinical trials must also be submitted to an institutional review board, or IRB, for approval. An IRB may also require the clinical trial at the site to be halted, either temporarily or permanently, for failure to comply with the IRB’s requirements, or may impose other conditions.

Clinical trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap or be combined. In Phase 1, the initial introduction of the drug into human patients, the drug is tested to assess safety, tolerance, metabolism, pharmacokinetics, pharmacological actions, side effects associated with increasing doses and, if possible, early evidence of effectiveness. Phase 2 usually involves clinical trials in a limited patient population to determine the effectiveness of the drug for a specific indication, dosage tolerance and optimum dosage and to identify possible adverse effects and safety risks. In certain instances, such as rare, serious diseases with high unmet need, a single Phase 2 trial may provide sufficient evidence of clinical effect to form an adequate basis for labeling. Phase 3 clinical trials are usually undertaken to further evaluate clinical efficacy and safety in a larger number of patients, providing statistical evidence of treatment effect, to permit the FDA to assess the overall benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug.

After completion of the required clinical testing, an NDA is prepared and submitted to the FDA. FDA approval of the NDA is required before marketing of the product may begin in the United States. The NDA must include the results of all preclinical, clinical and other testing and a compilation of data relating to the product’s pharmacology, chemistry, manufacture and controls. The cost of preparing and submitting an NDA is substantial.

The FDA has 60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the agency’s threshold determination that it is sufficiently complete to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review. The FDA has agreed to certain performance goals in the review of NDAs to encourage timeliness. Most applications for standard review drug products are reviewed within 12 months from submission; most applications for priority review drugs are reviewed within eight months from submission. Priority review can be applied to drugs that the FDA determines offer major advances in the treatment of a serious condition or provide a treatment where no adequate therapy exists. The review process for both standard and priority review may be extended by the FDA for three additional months to consider certain late-submitted information, or information intended to clarify information already provided in the submission.

The FDA may also refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to an outside advisory committee—typically a panel that includes clinicians and other experts—for review, evaluation and a recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations.

Before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the FDA will inspect the facility or the facilities at which the drug is manufactured. The FDA will not approve the product unless compliance with current good manufacturing practice, or cGMP—a quality system regulating manufacturing—is satisfactory and the NDA contains data that provide substantial evidence that the drug is safe and effective in the indication studied.

After the FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter. A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing, or information, for the FDA to reconsider the application. If, or when, those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter. The FDA has committed to reviewing such resubmissions in two or six months depending on the type of information included.

An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. As a condition of NDA approval, the FDA may require a risk evaluation and mitigation strategy, or REMS, to help ensure that the benefits of the drug outweigh the potential risks. REMS can include medication guides, communication plans for healthcare professionals, and elements to assure safe use, or ETASU. ETASU can include, but is not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring and the use of patient registries. The requirement for a REMS can materially affect the potential market and profitability of the drug. Moreover, product approval may require substantial post-approval testing and surveillance to monitor the drug’s safety or efficacy. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or problems are identified following initial marketing.

Changes to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA approval of a new NDA or NDA supplement before the change can be implemented. An NDA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing NDA supplements as it does in reviewing NDAs.

Project Optimus

In 2021, the FDA’s Oncology Center of Excellence launched Project Optimus, an initiative to reform the dose optimization and dose selection paradigm in oncology drug development to emphasize selection of an optimal dose, which is a dose that maximizes not only the efficacy of a drug but also its safety and tolerability. Project Optimus was driven by the FDA’s concerns that the historical approach to dose selection, which generally determined the maximum tolerated dose, may have resulted in doses and schedules of molecularly targeted therapies that were inadequately characterized before the initiation of pivotal trials.

Project Optimus requires the implementation of strategies for dose finding and dose optimization that leverage nonclinical and clinical data in dose selection, including randomized evaluations of a range of doses in trials. This initiative emphasizes the performance of dose finding and dose optimization trials as early and efficiently as possible in development programs. In support of this initiative, the FDA may request sponsors of oncology product candidates to conduct dose optimization trials pre- or post-approval.

Fast Track Designation and Accelerated Approval

The FDA is required to facilitate the development, and expedite the review, of drugs that are intended for the treatment of a serious or life-threatening disease or condition for which there is no effective treatment and which demonstrate the potential to address unmet medical needs for the condition. Under the Fast Track program, the sponsor of a new product candidate may request that the FDA designate the product candidate for a specific indication as a Fast Track drug concurrent with, or after, the filing of the IND for the product candidate. The FDA must determine if the product candidate qualifies for Fast Track Designation within 60 days of receipt of the sponsor’s request.

If a submission is granted Fast Track Designation, the sponsor may engage in more frequent interactions with the FDA, and the FDA may review sections of the NDA before the application is complete. This rolling review is available if the applicant provides, and the FDA approves, a schedule for the submission of the remaining information and the applicant pays applicable user fees. However, the FDA’s time period goal for reviewing an application does not begin until the last section of the NDA is submitted. Additionally, Fast Track Designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process.

Under the FDA’s accelerated approval regulations, the FDA may approve a drug for a serious or life-threatening illness that provides meaningful therapeutic benefit to patients over existing treatments based upon 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.

In clinical trials, a surrogate endpoint is a measurement of laboratory or clinical signs of a disease or condition that substitutes for a direct measurement of how a patient feels, functions or survives. Surrogate endpoints can often be measured more easily or more rapidly than clinical endpoints. A product candidate approved on this basis is subject to rigorous post-approval compliance requirements, including the completion of Phase 4, or post-approval clinical trials, to confirm the effect on the clinical endpoint. Failure to conduct required post-approval trials, or confirm a clinical benefit during post-approval trials, will allow the FDA to withdraw the drug from the market on an expedited basis. All promotional materials for product candidates approved under accelerated regulations are subject to priority review by the FDA.

Breakthrough Therapy Designation

A Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). The FDA may expedite the development and review of the application for approval of drugs that are intended to treat a serious or life-threatening disease or condition where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Under the Breakthrough Therapy program, the sponsor of a new product candidate may request that the FDA designate the product candidate for a specific indication as a Breakthrough Therapy concurrent with, or after, the filing of the IND for the product candidate. A Breakthrough Therapy Designation provides all Fast Track Designation features, offers intensive guidance on an efficient drug development program and ensures organizational commitment involving senior management at FDA. The FDA must determine if the product candidate qualifies for Breakthrough Therapy Designation within 60 days of receipt of the sponsor’s request.

Orphan Drug Designation and Exclusivity

The Orphan Drug Act provides incentives for the development of products intended to treat rare diseases or conditions. Under the Orphan Drug Act, the FDA may grant orphan designation to a drug intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making a drug available in the United States for this type of disease or condition will be recovered from sales of the product. If a sponsor demonstrates that a drug is intended to treat a rare disease or condition, the FDA will grant orphan designation for that product for the orphan disease indication, assuming the same drug has not already been approved for the indication for which the sponsor is seeking orphan designation. If the same drug has already been approved for the indication for which the sponsor is seeking orphan designation, the sponsor must present a plausible hypothesis of clinical superiority to obtain orphan designation. Orphan designation must be requested before submitting an NDA. After the FDA grants orphan designation, the FDA discloses the identity of the therapeutic agent and its potential orphan use.

Orphan designation may provide manufacturers with benefits such as research grants, tax credits, PDUFA application fee waivers, and eligibility for orphan drug exclusivity. If a product that has orphan designation subsequently receives the first FDA approval of the active moiety for that disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity, which for seven years prohibits the FDA from approving another product with the same active ingredient for the same indication, except in limited circumstances. Orphan drug exclusivity will not bar approval of another product under certain circumstances, including if a subsequent product with the same active ingredient for the same indication is shown to be clinically superior to the approved product on the basis of greater efficacy or safety or is shown to provide a major contribution to patient care or if the company with orphan drug exclusivity is not able to meet market demand. Further, the FDA may approve more than one product for the same orphan indication or disease as long as the products contain different active ingredients. Moreover, competitors may receive approval of different products for the indication for which the orphan drug has exclusivity or obtain approval for the same product but for a different indication for which the orphan drug has exclusivity.

In the European Union, orphan designation also entitles a party to financial incentives such as reduction of fees or fee waivers and a grant of ten years of market exclusivity following drug or biological product approval. This period may be reduced to six years if the orphan 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 designation must be requested prior to submission of an application for marketing approval. Orphan designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. An orphan drug designation does not obviate, in certain circumstances, the need to evaluate a product in pediatric patients.

Post-Approval Requirements

Once an NDA is approved, a product will be subject to certain post-approval requirements. For instance, the FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the internet. Drugs may be marketed only for the approved indications and in accordance with the provisions of the approved labeling. However, companies may share truthful and not misleading information that is otherwise consistent with the drug’s FDA approved labeling.

Adverse event reporting and submission of periodic reports are required following FDA approval of an NDA. The FDA also may require post-approval Phase 4 testing, REMS and surveillance to monitor the effects of an approved product or the FDA may place conditions on an approval that could restrict the distribution or use of the product. In addition, quality control, drug manufacture, packaging and labeling procedures must continue to conform to cGMP after approval. Drug manufacturers and certain of their subcontractors are required to register their establishments with the FDA and certain state agencies. Registration with the FDA subjects entities to periodic unannounced inspections by the FDA, during which the agency inspects manufacturing facilities to assess compliance with cGMP. Accordingly, manufacturers must continue to expend time, money and effort in the areas of production and quality-control to maintain compliance with cGMP. Regulatory authorities may withdraw product approvals or request product recalls if a company fails to comply with regulatory standards, if it encounters problems following initial marketing or if previously unrecognized problems are subsequently discovered.

Pediatric Information

Under the Pediatric Research Equity Act, or PREA, NDAs or supplements to NDAs must contain data to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the drug is safe and effective. The FDA may grant full or partial waivers, or deferrals, for submission of data. Unless otherwise required by regulation, PREA does not apply to any drug for an indication for which orphan designation has been granted.

The Best Pharmaceuticals for Children Act, or BPCA, provides NDA holders a six-month extension of any exclusivity—patent or non-patent—for a drug if certain conditions are met. Conditions for exclusivity include the FDA’s determination that information relating to the use of a new drug in the pediatric population may produce health benefits in that population, the FDA making a written request for pediatric trials and the applicant agreeing to perform, and reporting on, the requested trials within the statutory timeframe. Applications under the BPCA are treated as priority applications, with all of the benefits that designation confers.

FDA Regulation of Companion Diagnostics

Our drug products may rely upon in vitro companion diagnostics for use in selecting the patients that are more likely to respond to our cancer therapeutics. If safe and effective use of a therapeutic product depends on selecting patients whose tumor harbors a genetic abnormality, the FDA generally will require approval or clearance of an in vitro diagnostic, or IVD, at the same time that the FDA approves the therapeutic product in order to allow for its commercial use.

Laboratory developed tests that are subject to Clinical Laboratory Improvement Amendments regulations and the Public Health Service Act have been accepted, to date, for the conduct of clinical trials. The FDA has required in vitro companion diagnostics intended to select the patients who will respond to cancer treatment to obtain a premarket approval, or PMA, for that diagnostic simultaneously with approval of the drug. The FDA has indicated that it will require PMA approval of one or more in vitro companion diagnostics to identify patient populations suitable for our cancer therapies. The review of these in vitro companion diagnostics in conjunction with the review of our cancer treatments involves coordination of review by the FDA’s Center for Drug Evaluation and Research and by the FDA’s Center for Devices and Radiological Health.

The PMA process, including the gathering of clinical and nonclinical 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 subject to an application fee. In addition, 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. 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.

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. If the FDA’s evaluation of the PMA application is favorable, the FDA typically issues an approvable letter requiring the applicant’s agreement to specific conditions, 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.

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.

Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions: warning letters, fines, injunctions, civil or criminal penalties, recall or seizure of current or future products, operating restrictions, partial suspension or total shutdown of production, denial of submissions for new products or withdrawal of PMA approvals.

Clinical Trials and IDEs

A clinical trial is almost always required to support a PMA application. In some cases, one or more smaller investigational device exemption, or IDE, studies may precede a pivotal clinical trial intended to demonstrate the safety and efficacy of the investigational device.

All clinical studies of investigational devices must be conducted in compliance with the FDA’s requirements. If an investigational device could pose a significant risk to patients pursuant to FDA regulations, the FDA must approve an IDE application prior to initiation of investigational use. For a clinical trial where the IVD result directs the therapeutic care of patients with cancer, we believe that the FDA may consider use of the IVD as part of the clinical investigation to present significant risk and require an IDE application.

An IDE application must be supported by appropriate data, such as laboratory test results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound. The FDA typically grants IDE approval for a specified number of patients. A non-significant risk device does not require FDA approval of an IDE. Both significant risk and non-significant risk investigational devices require approval from IRBs at the trial centers where the device will be used.

During the clinical trial, the sponsor must comply with the FDA’s IDE requirements for investigator selection, clinical trial monitoring, reporting and record keeping. The investigators must obtain patient informed consent, rigorously follow the investigational plan and trial protocol, control the disposition of investigational devices and comply with all reporting and record keeping requirements. Prior to granting PMA approval, the FDA typically inspects the records relating to the conduct of the trial and the clinical data supporting the PMA application for compliance with applicable requirements.

Although the QSR does not fully apply to investigational devices, the QSR requirement for controls on design and development does apply. The sponsor also must manufacture the investigational device in conformity with the quality controls described in the IDE application and any conditions of IDE approval that the FDA may impose with respect to manufacturing.

Foreign Regulation

In addition to regulations in the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our product candidates to the extent we choose to sell any products outside of the United States. Whether or not we obtain FDA approval for a product, we must obtain approval of a product by regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. The approval process varies based on regulations enacted by regional entities such as the EMA as well as country-specific health authorities such as Japan’s PMDA, and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country. As in the United States, post-approval regulatory requirements, such as those regarding product manufacture, marketing, or distribution would apply to any product that is approved outside the United States.

Government authorities in the United States, at the federal, state and local level, and in other countries, extensively regulate, among other things, the research, development, testing, manufacture, including any manufacturing changes, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, post-approval monitoring and reporting, import and export of pharmaceutical products, such as those we are developing.

There are also foreign regulations governing the privacy and security of health information and the use of personal data to sell or market products, including the General Data Protection Regulation (EU) 2016/679, or GDPR, which imposes privacy and security obligations on any entity that collects and/or processes personal data from individuals located in the European Union and/or sells or markets products in the European Union. Under the GDPR, fines of up to 20 million euros or up to 4% of the annual global turnover of the infringer, whichever is greater, could be imposed for significant non-compliance.

Additional Healthcare Regulations and Environmental Matters

In addition to FDA restrictions on marketing of pharmaceutical products, we are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which we conduct our business. These laws include transparency laws, anti-kickback statutes, false claims laws, health information privacy and security statutes and regulations regarding providing drug samples, among others.

The federal Anti-Kickback Statute prohibits, among other things, individuals and entities from knowingly and willfully offering, paying, soliciting or receiving remuneration to induce, or in return for, either the referral of an individual or the purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item or service reimbursable under Medicare, Medicaid or other federally financed healthcare programs.

Federal false claims laws, including the False Claims Act, prohibit, among other things, any person or entity from knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to have a false claim paid. Pharmaceutical companies have been prosecuted under these laws for allegedly inflating drug prices they report to pricing services, which in turn were used by the government to set Medicare and Medicaid reimbursement rates, and for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. In addition, certain marketing practices, including off-label promotion, may also violate false claims laws.

The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters.

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or the HITECH Act, and their implementing regulations, also impose obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of protected health information used and disclosed by covered entities and their business associates that create, receive, maintain, or transmit protected health information in connection with providing a service for or on behalf of a covered entity, as well as their covered subcontractors. Many states and foreign jurisdictions also have laws and regulations that govern the privacy and security of individually identifiable health information, and such laws often vary from one another and from HIPAA.

The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services, or CMS, information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals. It also requires certain manufacturers and group purchasing organizations to report annually ownership and investment interests held by physicians and their immediate family members.

The majority of states also have statutes or regulations similar to the federal Anti-Kickback Statute and false claims laws, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor. 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 and may require drug manufacturers to track and report information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures or drug pricing. Certain state and local laws also require the registration of pharmaceutical sales representatives. Our activities may also be subject to certain state laws regarding the privacy and security of health information that may not be preempted by HIPAA.

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 could be subject to challenge under one or more of such laws. If our operations are found to be in violation of any of the federal and state laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including potentially significant administrative, criminal and civil penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government healthcare programs, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of pre-marketing product approvals, private “qui tam” actions brought by individual whistleblowers in the name of the government or refusal to allow us to enter into supply contracts, including government contracts, 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.

In addition to regulatory schemes that apply, or may in the future apply, to our business, we are or may become subject to various environmental, health and safety laws and regulations governing, among other things, laboratory procedures and any use and disposal by us of hazardous or potentially hazardous substances used in connection with our research and development activities. We do not presently expect such environmental, health and safety laws or regulations to materially impact our present or planned future activities.

Coverage and Reimbursement

Sales of any of our product candidates that may be approved, including any drug or companion diagnostics we or our collaborators may develop, will depend, in part, on the extent to which the cost of the product will be covered by third-party payors. Third-party payors may limit coverage to an approved list of products, or formulary, which might not include all drug products approved by the FDA for an indication. A payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Further, one payor’s determination to provide coverage for a drug product does not assure that other payors will also provide coverage for the drug product. Adequate third-party payor reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development. Further, coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. Any companion diagnostic that we or our collaborators develop will be subject to separate coverage and reimbursement determinations by third-party payors.

Any product candidates for which we obtain marketing approval may not be considered medically necessary or cost-effective by third-party payors, and we may need to conduct expensive pharmacoeconomic studies in the future to demonstrate the medical necessity and/or cost effectiveness of any such product. Nonetheless, our product candidates may not be considered medically necessary or cost effective. The U.S. government, state legislatures and foreign governments have shown increased interest in implementing cost containment programs to limit government-paid health care costs, including price controls, restrictions on reimbursement and requirements for substitution of generic products. Continued interest in and adoption of such controls and measures, and tightening of restrictive policies in jurisdictions with existing controls and measures, could limit payments for pharmaceuticals such as the product candidates we are developing.

Health Reform

The United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably. Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and expanding access. In the United States, the pharmaceutical industry has been a specific focus of these efforts and has been significantly affected by major legislative initiatives. By way of example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively the ACA, was signed into law. The ACA was intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add transparency requirements for the healthcare and health insurance industries, impose taxes and fees on the health industry and impose additional health policy reforms. There have been executive, judicial and Congressional challenges and amendments to certain aspects of the ACA. For example, on August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022, or IRA, which, among other reforms, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and through a newly established manufacturer discount program. For that and other reasons, it is currently unclear how the IRA will be effectuated, and while

the impact of the IRA on the pharmaceutical industry cannot yet be fully determined, it is likely to be significant. It is possible that the ACA will be subject to judicial or Congressional challenges in the future. It is unclear how any such challenges and the healthcare reform measures of the second Trump administration will impact the ACA.

Recently there has been heightened governmental scrutiny over the manner by which manufacturers set prices for their marketed products. For example, there have been several recent U.S. Presidential executive orders, Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the cost of drugs under Medicare, and reform government program reimbursement methodologies for drug products. For example, the IRA, among other things, (1) directs the U.S. Department of Health and Human Services, or HHS, to negotiate the price of certain high-expenditure, single-source drugs covered under Medicare that have been on the market for at least seven years, or Medicare Drug Price Negotiation Program, and (2) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. These provisions began to take effect progressively in fiscal year 2023. On August 15, 2024, HHS announced the agreed-upon prices of the first ten drugs that were subject to price negotiations, although the Medicare Drug Price Negotiation Program is currently subject to legal challenges. On January 17, 2025, HHS selected 15 additional products covered under Part D for price negotiation in 2025. Each year thereafter more Part B and Part D products will become subject to the Medicare Drug Price Negotiation Program. Further, on December 7, 2023, the Biden administration announced an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act of 1980, or Bayh-Dole Act. On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights. While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, on January 5, 2024, the FDA approved Florida’s Section 804 Importation Program, or SIP, proposal to import certain drugs from Canada for specific state healthcare programs. It is unclear how this program will be implemented, including which drugs will be chosen, and whether it will be subject to legal challenges in the United States or Canada. Other states have also submitted SIP proposals that are pending review by the FDA. Any such approved importation plans, when implemented, may result in lower drug prices for products covered by those programs.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. These changes included aggregate reductions to Medicare payments to providers of up to 2% per fiscal year effective April 1, 2013 and, due to subsequent legislative amendments to the statute, will stay in effect through 2032. Additionally, on March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminated the statutory Medicaid drug rebate cap, previously set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, effective January 1, 2024.

It is possible that other healthcare reform measures may be adopted in the future, particularly in light of the recent U.S. Presidential and Congressional elections. These new laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on customers for our drugs, if approved, and, accordingly, our financial operations.

In the coming years, additional legislative and regulatory changes could be made to governmental health programs that could significantly impact pharmaceutical companies and the success of our product candidates.

Human Capital

As of December 31, 2024, we employed 192 full-time employees. Our employees were comprised of 61% in research, development and supply chain and 39% in commercial and general and administrative capacities. As of such date, all our employees were based in the United States except one employee who worked from an international location. We also engage temporary consultants and contractors. All of our employees are at-will employees, which means that each employee can terminate his or her relationship with us and we can terminate our relationship with him or her at any time and none of our employees are represented by a labor union with respect to his or her employment with us.

We believe our employees are the driving force to achieving our business goals and growth strategy and we continuously monitor our demand for capable and talented people to support our mission. We invest in our employees through high-quality benefits and various health and wellness initiatives, competitive compensation packages and practicing fair compensation practices. For our talent pipeline development, we work closely with individual business functions to provide training and hands-on support for managers and leaders, to assess talent and identify development opportunities. Our human capital strategy is overseen at the highest levels of our organization, from the board of directors and across our senior management.

Our Code of Business Conduct and Ethics ensures that our core values of respect, integrity, collaboration, innovation, trust, and excellence are applied throughout our operations. Our Code of Business Conduct and Ethics serves as a critical tool to help all of us recognize and report unethical conduct, while preserving and nurturing our culture of honesty and accountability. We provide a comprehensive training program on our Code of Business Conduct and Ethics for all of our staff and management employees annually.

We are an Equal Opportunity and Affirmative Action employer in compliance with the requirements of the Executive Order 11246 of the Rehabilitation Act of 1973 and the Vietnam Era Veterans’ Readjustment Assistance Act. We pride ourselves on our commitment to fostering a diverse, inclusive, and empowered workforce. In 2020, we established what is now called the Diversity, Equity and Inclusion Committee, or DE&I Committee, an employee-led committee consisting of members from across the organization that focuses on matters related to our corporate culture and community outreach. The DE&I Committee’s initiatives include internal education, professional development, community service, external mentoring and clinical trial equity.

Corporate Information

Our corporate headquarters are located at 12730 High Bluff Drive, Suite 400, San Diego, California 92130, and our telephone number is (858) 500-8800. We also occupy offices in Boston, Massachusetts and lab space in San Diego, California. We maintain a website at www.kuraoncology.com. Our website and the information contained on, or that can be accessed through, the website will not be deemed to be incorporated by reference in, and are not considered part of, this Annual Report. Our Annual Reports on Form 10‑K, Quarterly Reports on Form 10‑Q, Current Reports on Form 8‑K and amendments to such reports filed or furnished pursuant to Section 13(a) and 15(d) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, are available free of charge on the Investors & Media portion of our website as soon as reasonably practical after we electronically file such material with, or furnish it to, the SEC.

All brand names or trademarks appearing in this Annual Report are the property of their respective holders. Use or display by us of other parties’ trademarks, trade dress, or products in this Annual Report is not intended to, and does not, imply a relationship with, or endorsements or sponsorship of, us by the trademark, trade dress or product owners.

Item 1A. Risk Factors.

RISK FACTORS

Except for the historical information contained herein or incorporated by reference, this Annual Report and the information incorporated by reference contains forward-looking statements that involve risks and uncertainties. These statements include projections about our accounting and finances, plans and objectives for the future, future operating and economic performance and other statements regarding future performance. These statements are not guarantees of future performance or events. Our actual results may differ materially from those discussed here. Factors that could cause or contribute to differences in our actual results include those discussed in the following section, as well as those discussed in Part II, Item 7 entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere throughout this Annual Report and in any other documents incorporated by reference into this Annual Report. You should consider carefully the following risk factors, together with all of the other information included or incorporated in this Annual Report. Each of these risk factors, either alone or taken together, could adversely affect our business, operating results and financial condition, as well as adversely affect the value of an investment in our common stock. There may be additional risks that we do not presently know of or that we currently believe are immaterial which could also impair our business and financial position.

Risks Related to the Discovery and Development of Our Product Candidates

We are highly dependent on the success of our lead product candidate, ziftomenib, which is still in clinical development, and we cannot give any assurance that ziftomenib or any of our other product candidates will receive regulatory approval, which is necessary before they can be commercialized. Even if our product candidates receive regulatory approval and are commercialized, they may be less competitive and generate less revenue than we anticipate.

Our future success is highly dependent on obtaining regulatory approval for, and then successfully commercializing, our lead product candidate, ziftomenib. Our business depends entirely on the successful development and commercialization of our product candidates. We have not completed the development of any product candidates; we currently generate no revenues from sales of any product, and we have not demonstrated that we can successfully develop a marketable product.

We may subsequently learn of certain information or data that the FDA may request, which may necessitate conducting additional preclinical studies or generating additional information at significant cost in terms of both time and expense, including under a clinical hold imposed on an IND. For example, if the FDA does not believe we have sufficiently demonstrated that the selected doses for our investigational products maximize not only the efficacy of the investigational product, but the safety and tolerability as well, our ability to initiate new studies may be delayed. Even if we conducted the additional studies or generated the additional information requested, the FDA could disagree that we have satisfied their requirements, all of which will cause significant delays and expense to our programs.

Our product candidates will require additional clinical development, evaluation of clinical, preclinical and manufacturing activities, regulatory approval in one or more jurisdictions, substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenues from product sales. We are not permitted to market or promote any product candidates before we receive regulatory approval from the FDA or comparable foreign regulatory authorities, and we may never receive such regulatory approvals. Although the scope of regulatory approval is similar in other countries, in some countries there are additional regulatory requirements and potential regulatory risks and we cannot predict success in these jurisdictions.

There is no guarantee that our clinical trials will be completed on time or at all. Prior to receiving approval, if any, to commercialize a product candidate in the United States or internationally, we or our collaborators must demonstrate to the satisfaction of the FDA and other regulatory authorities that such product candidate is safe and effective for its intended use. The results from preclinical studies and clinical trials can be interpreted in different ways, and the favorable results from previous trials of a product candidate may not be replicated in subsequent clinical trials. Even if we believe the preclinical or clinical data are promising, such data may not be sufficient to support approval by the FDA and other regulatory authorities. We maintain frequent, ongoing dialogue with the FDA and other regulatory bodies regarding our clinical trial designs, including the patient selection criteria, dosing plans and statistical analysis plans. There is a risk that the FDA or other regulatory agencies could at any time raise objections to the design or conduct of our clinical trials. Any such objections could delay the initiation or completion of our registration-directed clinical trials.

Although we believe there may be potential to pursue a path to approval for ziftomenib for the treatment of patients with particular subtypes of AML, we cannot guarantee that ziftomenib will demonstrate sufficient safety and tolerability and clinical activity in such subtypes to support an application for approval. Even if ziftomenib demonstrates sufficient activity in one patient subtype, such as patients with NPM1-mutant AML, to support an application in that subset, there can be no assurance it will demonstrate sufficient activity to support an application for approval in other patient subsets. Even if the trial results from ziftomenib demonstrate a compelling clinical benefit, the FDA has substantial discretion in the approval process and may not grant approval based on data generated by us.

If the results of our trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, we may be required to expend significant additional resources to conduct additional trials in support of potential approval of ziftomenib, KO-2806 and tipifarnib or our other product candidates.

We have not previously submitted an NDA to the FDA, or similar product approval filings to comparable foreign authorities, or received marketing approval for any product candidate, and we cannot be certain that any of our product candidates will be successful in clinical trials or receive regulatory approval for any indication. Although we expect to submit an NDA to the FDA for ziftomenib for the treatment of relapsed or refractory NPM1-mutant AML in the second quarter of 2025, we cannot anticipate whether or when we will seek regulatory review of a product candidate for any other indications. If we do not receive regulatory approvals for and successfully commercialize any of our product candidates on a timely basis or at all, we may not be able to continue our operations. Even if we successfully obtain regulatory approvals to market one of our product candidates, our revenues may be dependent, in part, on our third-party collaborator’s ability to co-commercialize such product candidate or to commercialize the companion diagnostic for such product candidate, as applicable. Further, our revenues may be dependent on the size of the markets in the territories for which we gain regulatory approval and have commercial rights. If the market opportunities for the treatment of NPM1-mutant AML, KMT2A-rearranged AML, solid tumor indications and other diseases are not as significant as we estimate, our business and prospects may be harmed.

Our discovery, preclinical and clinical development activities are primarily focused on the development of targeted therapeutics for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop drugs may never lead to marketable products.

The discovery and development of targeted therapeutics for patients with genetically defined cancers, and the scientific discoveries that form the basis for our efforts to discover and develop product candidates, are a relatively new and rapidly evolving area of science. The scientific evidence to support the feasibility of developing product candidates based on these discoveries is both preliminary and limited. The patient populations for our product candidates are not completely defined but are substantially smaller than the general treated cancer population, and patients will need to be screened and identified in order to be eligible for our therapies. Successful identification of patients is dependent on several factors, including screening a sufficient number of patients to identify whether they harbor a particular genetic alteration or expression level, achieving certainty as to how specific genetic alterations or expression levels respond to our product candidates and developing companion diagnostics to identify such genetic alterations or expression levels. Furthermore, even if we are successful in identifying patients, we cannot be certain that the resulting patient populations will be large enough to allow us to successfully commercialize any products for which we are able to obtain marketing approval and achieve profitability. Therefore, we do not know if our approach of treating patients with genetically defined cancers will be successful. If our approach is unsuccessful, our business will suffer.

In order to execute on our strategy of advancing the clinical development of our product candidates for patients with genetically defined cancers, we have designed our clinical trials, and expect to design future clinical trials, of such product candidates to include patients who harbor a particular attribute such as a particular genetic alteration, tumor histology or expression level that we believe contribute to or are associated with particular cancer subsets. Our goal in doing this is to enroll patients who have the highest probability of responding to our product candidate and, in our Phase 1 and/or proof-of-concept Phase 2 clinical trials, to show early and statistically significant evidence of clinical efficacy. Potential molecular biomarkers we have identified in retrospective analyses of data from clinical trials of a product candidate in certain cancer indications may not be prospectively validated as biomarkers in future clinical trials that we may conduct in these indications. If we are unable to identify molecular or genetic alterations, or biomarkers, that are predictive of response to our product candidates, or we are unable to include patients who harbor the applicable genetic alterations or expression levels in our clinical trials, or if our product candidates fail to work as we expect, our ability to assess the therapeutic effect, seek participation in FDA expedited review and approval programs, including Breakthrough Therapy Designation, Fast Track Designation, Priority Review and Accelerated Approval, or otherwise to seek to accelerate clinical development and regulatory timelines, could be compromised, resulting in longer development times, larger clinical trials and a reduced likelihood of obtaining regulatory approval.

We may find it difficult to enroll patients in our clinical trials. Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates.

Identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success. The timing of our clinical trials depends in part on the speed at which we can recruit patients to participate in testing our product candidates, and we may experience delays in our clinical trials if we encounter difficulties in enrollment.

In addition to the potentially small populations for our clinical trials, the eligibility criteria of our clinical trials will further limit the pool of available trial participants as we will require that patients have specific characteristics that we can measure or to assure their disease is either severe enough or not too advanced to include them in a trial. Additionally, the process of finding and diagnosing patients may prove costly. For example, certain genetic alterations are not included in existing diagnostic panels, have unknown prognostic significance and/or are not targeted by any FDA-approved treatment, and as a result, biomarker testing for such alterations is not routinely performed. To seek to address these limitations, we have contracted with third-party laboratories to facilitate the genetic screening of patients for our clinical sites. However, there is no guarantee that these efforts will be effective.

We also may not be able to identify, recruit and enroll a sufficient number of patients to complete our clinical trials because of the perceived risks and benefits of the product candidate under trial including the number and frequency of trial required procedures and tests, the availability and efficacy of competing therapies and clinical trials, the proximity and availability of clinical trial sites for prospective patients, and the patient referral practices of physicians. Further, if patients do not comply with clinical trial process and procedure and, for example, drop out, miss scheduled doses or follow-up visits, or fail to follow trial protocols, then the integrity of data from our trials may be compromised or not accepted by the FDA or other regulatory authorities.

Additionally, in estimating the frequency of biomarkers, we rely on data published in the scientific literature as well as our experience and that of our collaborators. The technologies used to identify mutations in published datasets may be different from the technologies we are using currently, which may make it more difficult to compare results across clinical trials or we may experience lower rates of mutation or other alteration frequencies in our clinical trials than provided in the current scientific literature. Moreover, sample quality in academic studies of molecular biomarkers may not reflect standard clinical practice that is focused on pathological diagnosis.

Even if patients carrying specific mutations or other genetic characteristics are identified, the potential clinical benefit of a product candidate may be delayed or reduced due to increased durations in time to disease progression in patients treated with first-line therapies and the number of patients who could benefit from such product candidate may be reduced. Potential trial subjects may also be located at too great a distance to participate at our clinical trial sites. Any delay or failure by us or third-party collaborators to screen patients or identify patients for enrollment in our ongoing clinical trials could delay or prevent us from completing our clinical trials which could prevent us from obtaining regulatory approval or commercializing our product candidates on a timely or profitable basis, or at all.

If we experience delays in the completion of, or termination of, any clinical trial of our product candidates, the commercial prospects of our product candidates may be harmed, and our ability to generate product revenue from any of these product candidates could be delayed or prevented. In addition, any delays in completing our clinical trials will increase our costs, slow down our product candidate development and approval process, and jeopardize our ability to commence product sales and generate revenue. Any of these occurrences may harm our business, financial condition, and prospects significantly. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates, including:

  • unforeseen safety issues or adverse side effects;
  • failure of our companion diagnostics to identify patients;
  • modifications to protocols of our clinical trials resulting from the FDA or comparable foreign regulatory authorities or institutional review board, or IRB, decisions; and
  • ambiguous or negative interim results of our clinical trials or results that are inconsistent with earlier results.

Clinical drug development involves a lengthy and expensive process with an uncertain outcome. The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of subsequent clinical trials, and preliminary or interim results of a clinical trial do not necessarily predict final 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.

The risk of failure for our product candidates is high. Before obtaining marketing approval from regulatory authorities for the sale of any product candidate, we must conduct extensive preclinical and clinical testing to demonstrate the safety and efficacy of our product candidates in humans. This testing is expensive, difficult to design and implement and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. Further, the results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of subsequent clinical trials, and preliminary or interim results of a clinical trial do not necessarily predict final results.

Results from clinical trials conducted at a single clinical site or a small number of clinical sites may not be predictive of results from additional clinical sites or from subsequent clinical trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their products. It is impossible to predict with certainty if or when any of our product candidates will prove effective or safe in humans or will receive regulatory approval.

We may experience delays in our clinical trials, and we do not know whether ongoing or planned clinical trials will begin or enroll patients on time, need to be redesigned or be completed on schedule, if at all. If the FDA, comparable foreign regulatory authorities or IRBs have comments on our study plans for our clinical trials that we are required to address, such trials may be delayed, or may not start at all. Clinical trials may be delayed, suspended or prematurely terminated at any time by us or by the FDA or other similar regulatory agency if it is determined at any time that patients may be or are being exposed to unacceptable health risks, including risk of death, or if compounds are not manufactured in compliance with current good manufacturing practice, or cGMP, regulations or with acceptable quality. There can be no assurance that the FDA or other similar regulatory agency will not put any of our product candidates on clinical hold in the future. For example, in November 2021, we reported that the FDA had placed the KOMET-001 trial on a partial clinical hold. The partial clinical hold was initiated following our report to the FDA of a Grade 5 serious adverse event potentially associated with DS, a known adverse event related to differentiating agents in the treatment of AML. Patients who were enrolled in the Phase 1b expansion cohorts at the time of the partial clinical hold were permitted to continue to receive ziftomenib, although no additional patients were to be enrolled until the partial clinical hold was lifted. In January 2022, we announced that the FDA had lifted the partial clinical hold on the KOMET-001 trial following agreement on our mitigation strategy for DS, and that the trial would resume screening and enrollment of new patients. We may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive marketing approval or commercialize our product candidates. Clinical trials may be delayed, suspended or prematurely terminated because costs are greater than we anticipate or for a variety of reasons, such as:

  • failure to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support the initiation or continuation of clinical trials;

  • delay or failure in reaching agreement with the FDA or a comparable foreign regulatory authority on a clinical trial design that we are able to execute;

  • delay or failure in obtaining authorization to commence a clinical trial or inability to comply with conditions imposed by a regulatory authority regarding the scope or design of a clinical trial;

  • delays in reaching, or failure to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective clinical trial sites;

  • inability, delay or failure in identifying and maintaining a sufficient number of clinical trial sites, many of which may already be engaged in other clinical programs;

  • delay or failure in recruiting and enrolling suitable subjects to participate in a clinical trial;

  • delay or failure in having subjects complete a clinical trial or return for post-treatment follow-up;

  • delay or failure in determining an acceptable dose and schedule for a product candidate in a clinical trial;

  • clinical sites and investigators deviating from clinical trial protocol, failing to conduct the clinical trial in accordance with regulatory requirements or dropping out of a clinical trial;

  • lack of adequate funding to continue the clinical trial, including the incurrence of unforeseen costs due to enrollment delays, requirements to conduct additional clinical trials and increased expenses associated with the services of our CROs and other third parties;

  • clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to redesign or modify our clinical trial protocols, conduct additional clinical trials or abandon product development programs;

  • 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 or participants may drop out of these clinical trials at a higher rate than we anticipate;

  • we may experience delays or difficulties in the enrollment of patients whose tumors harbor the specific genetic alterations that our product candidates are designed to target;

  • 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;

  • we may have difficulty partnering with experienced CROs that can screen for patients whose tumors harbor the applicable genetic alterations and run our clinical trials effectively;

  • regulators or IRBs 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;

  • 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; or

  • there may be changes in governmental regulations or administrative actions.

If we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of our product candidates or other testing, if the results of these clinical trials or tests are not positive or are only modestly positive or if there are safety concerns, we may:

  • be delayed in obtaining marketing approval for our product candidates;
  • not obtain marketing approval at all;
  • obtain approval for indications or patient populations that are not as broad as intended or desired;
  • obtain approval with labeling that includes significant use or distribution restrictions or safety warnings that could reduce the potential market for our products or inhibit our ability to successfully commercialize our products;
  • be subject to additional post-approval restrictions and/or testing requirements; or
  • have the product removed from the market after obtaining marketing approval.

Our product development costs will also increase if we experience delays in testing or marketing approvals. We do not know whether any of our preclinical studies or clinical trials will need to be restructured or will be completed on schedule, or at all. Significant preclinical or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize our product candidates and may harm our business and results of operations.

We anticipate that our current product candidates and any future product candidates may be used in combination with third-party drugs or biologics, some of which may still be in development, and we have limited or no control over the supply, regulatory status, or regulatory approval of such drugs or biologics.

We are currently developing our product candidates, and may develop future product candidates, for use in combination with one or more other cancer therapies, such as venetoclax, azacitidine, cytarabine, daunorubicin, gilteritinib, fludarabine, G-CSF, and idarubicin in the case of ziftomenib, cabozantinib and adagrasib in the case of KO-2806, and alpelisib in the case of tipifarnib, or other drugs, both approved and unapproved. Our ability to develop and ultimately commercialize our current product candidates and any future product candidates used in combination with another drug or biologic will depend on our ability, or the ability of third-party clinical trial sites on which we rely, to access such drugs or biologics on commercially reasonable terms for the clinical trials and their availability for use with the commercialized product, if approved. We cannot be certain that we, or third-party clinical trial sites on which we rely, will be able to secure a steady supply of such drugs or biologics on commercially reasonable terms or at all.

Any failure by us, or by third-party clinical trial sites on which we rely, to secure a steady supply of such drugs or biologics may delay our development timelines, increase our costs and jeopardize our ability to develop our current product candidates and any future product candidates as commercially viable therapies. If any of these occur, our business, financial condition, results of operations, stock price and prospects may be materially harmed.

Moreover, the development of product candidates for use in combination with another product or product candidate may present challenges that are not faced for single agent product candidates. The FDA or comparable foreign regulatory authorities 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. It is possible that the results of such trials could show that any positive previous trial results are attributable to the combination therapy and not our current product candidates and any future product candidates. Moreover, following product approval, the FDA or comparable foreign regulatory authorities 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 to satisfy such a requirement. Moreover, developments related 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, quality, manufacturing and supply issues, and changes to the standard of care.

In the event that any future collaborator or supplier cannot continue to supply their products on commercially reasonable terms, we would need to identify alternatives for accessing such products. Additionally, should the supply of products from any future collaborator or supplier be interrupted, delayed or otherwise be unavailable, our clinical trials may be delayed. In the event we are unable to source an alternative supply or are unable to do so on commercially reasonable terms, our business, financial condition, results of operations, stock price and prospects may be materially harmed.

In addition, to the extent a third-party clinical trial site on which we rely sources a combination therapy itself and does not submit the costs of such therapy to government programs or patients’ insurance, the costs of such therapy may be passed on to us, which could harm our business, financial condition, results of operations, stock price and prospects.

Our product candidates may cause serious adverse events or have unacceptable side effects that could delay, limit or prevent their development.

If our product candidates are associated with unacceptable side effects in preclinical or clinical trials or have characteristics that are unexpected, we may need to interrupt, delay or abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.

Any observed drug-related side effects could affect the ability of patients to tolerate potentially therapeutically effective doses of the drug, which in turn could affect patient recruitment or the ability of enrolled patients to complete the clinical trial or result in potential product liability claims. Additionally, if results of our ongoing or planned clinical trials reveal an unacceptable frequency and severity of serious adverse events or side effects, our trials could be suspended or terminated and the FDA or comparable foreign regulatory agencies could require us to cease further development of, or deny approval of, our product candidates for any or all targeted indications. Many compounds developed in the biopharmaceutical industry that initially showed promise in early-stage testing for treating cancer have later been found to cause side effects that prevented further development of those compounds. Any of these occurrences may significantly harm our business, financial condition and prospects.

The results of our Phase 1 KOMET-001 trial of ziftomenib in patients with relapsed or refractory AML were published in The Lancet Oncology in October 2024. Of the 83 patients with relapsed or refractory NPM1-mutant or KMT2A-rearranged AML dosed with ziftomenib in the Phase 1 trial, the most common TEAEs of any grade, occurring in ≥10% of patients, were diarrhea, nausea, anemia, febrile neutropenia, hypokalemia, differentiation syndrome, epistaxis, and pneumonia. The most common Grade ≥3 TEAEs, occurring in ≥10% of patients, were anemia, febrile neutropenia, pneumonia, differentiation syndrome, thrombocytopenia, and sepsis. 68 of 83 patients experienced a serious adverse event.

In the cohort of patients with relapsed or refractory NPM1-mutant AML treated with ziftomenib at the RP2D of 600 mg, which represented an older, heavily pretreated population, adverse events were manageable overall, with most TEAEs consistent with underlying AML in a heavily pretreated population. Only one patient in this cohort developed Grade 3 DS, which was successfully managed by protocol-specified mitigation. Drug-induced QTc prolongation was not observed and myelosuppression was infrequent in patients in this cohort. The most common TEAEs of any grade in this cohort, occurring in ≥30% of patients, were diarrhea, hypokalemia, nausea and anemia, and the most common Grade ≥3 TEAEs, occurring in >20% of patients, were anemia, diarrhea, febrile neutropenia, pneumonia and thrombocytopenia.

The safety and tolerability observed in the Phase 2 registration-directed KOMET-001 trial were consistent with previous reports.

In December 2024, we presented clinical data from the Phase 1a dose escalation portion of the KOMET-007 trial. Ziftomenib was generally well tolerated in combination at all dose levels evaluated across all cohorts. No dose-limiting toxicities, evidence of ziftomenib-associated QTc prolongation, drug-drug interactions or additive myelosuppression were observed. In the 7+3 combination cohorts, on-target DS occurred in 2% of patients. Grade ≥3 TEAEs occurring in ≥20% of patients were febrile neutropenia, platelet count reductions, anemia and decreased neutropenia count and decreased white blood cell count. In the venetoclax/azacitidine combination cohorts, on-target DS occurred in 8% of patients. Grade ≥3 TEAEs occurring in ≥20% of patients were decreased platelet count, anemia and febrile neutropenia. All instances of DS were manageable, and no patients discontinued participation due to DS.

Our FIT-001 trial represents the first time our KO-2806 compound has been tested in humans. While we can anticipate potential side effects based upon the safety profiles of tipifarnib and other FTIs, we cannot predict the type, frequency or severity of side effects that we will observe in patients treated with KO-2806.

Tipifarnib has been studied in more than 5,000 oncology patients and was generally well tolerated and exhibited a manageable side effect profile. The most common hematologic adverse events of any grade were neutropenia, or low white blood cell count, anemia and thrombocytopenia, or low platelet count. The most common non-hematologic adverse events of any grade were gastrointestinal system disorders such as nausea, anorexia, diarrhea and vomiting, fatigue and rash. Treatment discontinuation across the prior tipifarnib clinical trials has been in the range of approximately 20-25%. The side effects observed so far in our ongoing clinical trials of tipifarnib have been generally consistent with the prior observations; however, there is no guarantee that additional or more severe side effects will not be identified through further clinical trials.

Additionally, we may evaluate our product candidates in combination with third-party drugs or biologics, and safety concerns arising during a combination trial could negatively affect the individual development program of each candidate, as the FDA or comparable foreign regulatory authorities may require us to discontinue single-candidate trials until the contribution of each product candidate to any safety issues is better understood.

We may expend our limited resources to pursue a specific product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

Because we have limited financial and managerial resources, we must focus on a limited number of research programs and product candidates and on 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. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future discovery and preclinical development programs and product candidates for specific indications may not yield any commercially viable products.

Failure by us or our third-party collaborators to develop, validate and obtain regulatory approval for a diagnostic testing platform could harm our drug development strategy and operational results.

One of the central elements of our business strategy is to screen and identify subsets of patients with molecular or genetic alterations who may derive meaningful clinical benefit from our product candidates. In general, successful identification of these patient subsets depends on the development of sensitive, accurate and cost-effective molecular and other diagnostic tests and the widespread adoption and use of these tests at clinical sites to screen a sufficient number of patients to identify whether they are appropriate candidates for treatment with one of our product candidates.

As we do not have in-house diagnostic testing capabilities, we rely extensively on third-party collaborators for the development, validation and regulatory approval of these diagnostic tests. We and our third-party collaborators may encounter difficulties in developing, validating and obtaining regulatory approval for these diagnostic tests. We may also experience difficulties in having these diagnostic tests adopted and used by oncologists, both during the clinical development phase and if and when approved as a companion diagnostic for commercial sale.

Companion diagnostics are subject to regulation by the FDA and comparable foreign regulatory authorities as medical devices and require separate clearance or approval prior to their commercialization. To date, the FDA has frequently required a premarket approval application of companion diagnostics for cancer therapies. We presently anticipate that approved companion diagnostics will be required in order to obtain approval for ziftomenib in NPM1-mutant AML and KMT2A-rearranged AML, for KO-2806 in KRASG12C-mutant NSCLC and for tipifarnib in PIK3CA-dependent HNSCC. We and our third-party collaborators may encounter difficulties in developing, validating and obtaining approval for these companion diagnostics. Any delay or failure by us or third-party collaborators to develop, validate or obtain regulatory approval of a companion diagnostic could delay or prevent approval of our product candidates. We may also experience delays in developing a sustainable, reproducible and scalable manufacturing process or transferring that process to commercial partners or negotiating insurance reimbursement plans, all of which may prevent us from completing our clinical trials or commercializing our products on a timely or profitable basis, if at all.

Even if we or our companion diagnostic collaborators successfully obtain regulatory approval for the companion diagnostics for our product candidates, our collaborators:

  • may not perform their obligations as expected;
  • may not pursue commercialization of companion diagnostics for our therapeutic product candidates that achieve regulatory approval;
  • may elect not to continue or renew commercialization programs based on changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities;
  • may not commit sufficient resources to the marketing and distribution of such product or products; and
  • may terminate their relationship with us.

Additionally, we or our collaborators may encounter production difficulties that could constrain the supply of the companion diagnostics, affect the ease of use, affect the price or have difficulties gaining acceptance of the use of the companion diagnostics in the clinical community.

If companion diagnostics for use with our product candidates fail to gain market acceptance, our ability to derive revenues from sales of our product candidates could be harmed. If insurance reimbursement to the laboratories who perform the companion diagnostic tests is inadequate, utilization may be low, and patient tumors may not be comprehensively screened for the presence of the genetic markers that predict response to our product candidates. If we or our collaborators fail to commercialize these companion diagnostics, 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 our product candidates or do so on commercially reasonable terms, which could adversely affect and delay the development or commercialization of our product candidates.

Preclinical and clinical testing of tipifarnib that has been conducted to date may not have been performed in compliance with applicable regulatory standards, which could lead to increased costs or material delays for their further development.

We licensed the rights to develop tipifarnib from Janssen in December 2014, and the development of tipifarnib prior to our license was conducted wholly by Janssen or any third parties with which it had contracted. As a result, we were not involved with nor did we have any control over any of those development activities. Because we had no input on Janssen’s development activities relating to tipifarnib, we may discover that certain elements of the clinical development or manufacturing activities that Janssen performed were not performed in compliance with applicable regulatory standards or have otherwise been deficient, particularly relative to current requirements as development of tipifarnib began in the 1990s. Any such deficiency in the prior development of tipifarnib may adversely affect our ability to obtain regulatory approval for tipifarnib.

Risks Related to Our Financial Position and Need for Additional Capital

We expect to incur losses over the next several years and may never achieve or maintain profitability.

To date, we have financed our operations primarily through equity and debt financings and through revenues under the Kyowa Agreement. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. The net losses we incur may fluctuate significantly from quarter-to-quarter and year-to-year. We anticipate that our expenses will increase substantially if and as we:

  • continue research and development of our product candidates;
  • initiate new clinical trials for our product candidates;
  • seek marketing approvals for our product candidates;
  • enter into collaboration arrangements for combination drugs or biologics for our product candidates;
  • enter into collaboration arrangements for companion diagnostics for our product candidates;
  • fully develop a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;
  • maintain, expand and protect our intellectual property portfolio;
  • hire additional personnel;
  • add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts; and
  • incur increased costs as a result of continued operations as a public company.

To become and remain profitable, we must develop and eventually commercialize a product or products with significant market potential. This will require us to be successful in a range of challenging activities, including completing clinical trials of our product candidates, successfully developing companion diagnostics, obtaining marketing approval from the FDA and other global regulatory authorities for these product candidates, and the manufacturing, marketing and selling of these products for which we may obtain marketing approval. We may never succeed in these activities and, even if we do, may never generate revenues that are significant or even sufficient to achieve profitability. If we do 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 could decrease our value and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.

We are a clinical-stage company with no approved products and no historical product revenue. Consequently, we expect that our financial and operating results will vary significantly from period to period.

We are a clinical-stage company that has incurred losses since our inception and expect to continue to incur substantial losses in the foreseeable future. Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of uncertainty. We expect our actual financial condition and operating results to fluctuate significantly from quarter-to-quarter or year-to-year due to a variety of factors, many of which are beyond our control. Factors relating to our business that may contribute to these fluctuations include:

  • the success of our clinical trials through all phases of clinical development;
  • delays in the commencement, enrollment and completion of clinical trials;
  • our ability to secure and maintain collaborations, licensing or other strategic partnerships for the future development and/or commercialization of our product candidates, as well as meet the terms of those arrangements;
  • our and our third-party collaborators’ ability to develop and commercialize our product candidates, and our receipt of any future milestone or royalty payments under our current and any future collaboration agreements;
  • our and our third-party collaborators’ ability to develop and validate companion diagnostics for our product candidates;
  • our ability to obtain, as well as the timeliness of obtaining, additional funding to develop our product candidates;
  • the results of clinical trials or marketing applications for other product candidates that may compete with our portfolio of product candidates;
  • competition from existing products or new products that may receive marketing approval;
  • potential side effects of our product candidates that could delay or prevent approval or cause an approved drug to be taken off the market;
  • any delays in regulatory review and approval of our product candidates;
  • our ability to identify and develop additional product candidates;
  • the ability of patients or healthcare providers to obtain sufficient coverage and adequate reimbursement for our products;
  • our ability, and the ability of third parties, such as CROs, to adhere to clinical trial and other regulatory requirements;
  • the ability of third-party manufacturers to manufacture our product candidates and the ability to obtain key ingredients needed to produce materials for clinical trial material in order to conduct clinical trials and, if approved, successfully produce commercial products;
  • the costs to us, and our ability as well as the ability of any third-party collaborators, to obtain, maintain and protect our intellectual property rights;
  • costs related to and outcomes of any future intellectual property litigation;
  • our ability to adequately support future growth;
  • our ability to attract and retain key personnel to manage our business effectively;
  • changes in governmental regulations, healthcare policy, pricing and reimbursement systems and our ability to set and maintain prices in the United States and other territories; and
  • our ability to build our finance infrastructure and, to the extent required, improve our accounting systems and controls.

Accordingly, the likelihood of our success must be evaluated in light of many potential challenges and variables associated with a clinical-stage company, many of which are outside of our control, and past operating or financial results should not be relied on as an indication of future results. Fluctuations in our operating and financial results could cause our share price to decline. It is possible that in some future periods, our operating results will be above or below the expectations of securities analysts or investors, which could also cause our share price to decline.

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

We are a clinical-stage company with a limited operating history. Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, identifying and acquiring potential product candidates, undertaking preclinical, clinical and regulatory development of our product candidates and conducting pre-commercial and diagnostic related activities for our product candidates. We have not yet demonstrated our ability to successfully complete clinical trials or the development of companion diagnostics in support of FDA approval, obtain marketing approvals, manufacture a product at commercial scale, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Medicines, on average, take 10 to 15 years to be developed from the time they are discovered to the time they receive marketing approval. Consequently, any predictions you make about our future success or viability based on our short operating history to date may not be as accurate as they could be if we had a longer operating history.

In addition, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors as we transition from a company with a research and development focus to a company capable of supporting commercial activities, and we may not be successful in such a transition.

We may need to obtain substantial additional capital in connection with our continuing operations. If we are required to raise additional capital, doing so may cause dilution to our stockholders, restrict our operations or require us to relinquish certain rights to our technologies or product candidates.

If we need to raise additional capital in connection with our continuing operations, we would expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic partnerships or licensing arrangements. Additional capital may not be available on reasonable terms, if at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect rights of our stockholders as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic partnerships or licensing arrangements with third parties, such as our Kyowa Agreement, we may have to relinquish valuable rights to our product candidates, including our other technologies, future revenue streams or research programs, or grant licenses on terms that may not be favorable to us. As a result of the global pandemics, bank failures, actual or perceived changes in interest rates, potential tariffs and economic inflation, the global financial markets have experienced volatility and uncertainty. There can be no assurance that further volatility and uncertainty in the financial markets and declining confidence in economic conditions will not occur. If financial markets deteriorate, it may make any necessary debt or equity financing more difficult to obtain, more costly and/or more dilutive.

In November 2023, we entered into a Sales Agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., or the ATM Facility, under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million. We have not sold any shares of our common stock under the ATM Facility.

In November 2022, we entered into the Loan Agreement with the Lenders and Hercules, in its capacity as administrative agent and collateral agent for itself and the Lenders, providing for up to $125.0 million in a series of Term Loans. Upon entering into the Loan Agreement, we borrowed $10.0 million of an initial $25.0 million Tranche 1 Loan. In September 2023, the draw period for the remaining $15.0 million of the Tranche 1 Loan expired without us drawing down such additional loan. In March 2024, the draw period for the $35.0 million second tranche of Term Loans expired without us drawing down such additional loan and in December 2024, the draw period for the (i) $40.0 million third tranche of Term Loans and (ii) $25.0 million fourth tranche of Term Loans each expired without us drawing down such additional loans. No further Term Loans may be drawn under the Loan Agreement. On June 1, 2024, a minimum cash covenant commenced requiring us to hold cash in the United States and subject to a first-priority perfected security interest in favor of the Lenders in an amount greater than or equal to (x) 55.0% of the outstanding loan obligations if we have not received FDA approval for ziftomenib, or (y) 35.0% of the outstanding loan obligations if we have received FDA approval for ziftomenib, provided that neither (x) nor (y) will apply at any time our market capitalization is equal to or greater than $1,250.0 million. Since June 1, 2024, our market capitalization has not always exceeded $1,250.0 million, however, we have met the minimum cash covenant. While any amounts are outstanding under our term loan facility, we are subject to affirmative and restrictive covenants, including covenants regarding delivery of financial statements, maintenance of inventory, payment of taxes, maintenance of insurance, dispositions of property, business combinations or acquisitions, incurrence of additional indebtedness, transactions with affiliates and a minimum cash covenant, among other customary covenants. If we default under our term loan facility, the Lenders may accelerate our repayment obligations and take control of our pledged assets, potentially requiring us to renegotiate our agreement on terms less favorable to us or to immediately cease operations. Further, if we are liquidated, the Lenders’ right to repayment would be senior to the rights of the holders of our common stock to receive any proceeds from the liquidation. The Lenders could accelerate our obligations under the Loan Agreement upon the occurrence of an event of default, which includes, among other things, our failure to satisfy our payment obligations under the Loan Agreement, the breach of certain of our other covenants under the Loan Agreement or the occurrence of a material adverse change, thereby requiring us to repay the loan immediately or to attempt to reverse the declaration of default through negotiation or litigation. Any declaration by the Lenders of an event of default could significantly harm our business and prospects and could cause the price of our common stock to decline.

We cannot be certain that additional funding will be available on acceptable terms, or at all. Subject to limited exceptions, our term loan facility also prohibits us from incurring indebtedness without the prior written consent of the Lenders. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts.

Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions could adversely affect our current financial condition and projected business operations.

Events involving limitations to liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry, or concerns or rumors about any events of these kinds or other similar risks, have in the past led and may in the future lead to market-wide liquidity problems. We regularly maintain cash balances at third-party financial institutions in excess of the FDIC standard insurance limit, with balances concentrated at a small number of financial institutions. The failure of a bank, or other adverse conditions in the financial or credit markets impacting financial institutions at which we maintain balances, or with which we do business, could adversely impact our liquidity and financial performance. There can be no assurance that our deposits in excess of the FDIC or other comparable insurance limits will be backstopped by the United States or any applicable foreign government in the future or that any bank or financial institution with which we do business will be able to obtain needed liquidity from other banks, government institutions or by acquisition in the event of a future failure or liquidity crisis. In addition, if any of our partners or parties with whom we conduct business are unable to access funds due to the status of their financial institution, such parties’ ability to pay their obligations to us or to enter into new commercial arrangements requiring additional payments to us could be adversely affected.

Investor concerns regarding the U.S. or international financial systems could result in less favorable commercial financing terms, including higher interest rates or costs and tighter financial and operating covenants, or systemic limitations on access to credit and liquidity sources, thereby making it more difficult for us to acquire financing on acceptable terms or at all.

Risks Related to Our Dependence on Third Parties

Our collaboration with Kyowa Kirin is important to our business. If Kyowa Kirin ceases development efforts under our collaboration agreement, or if our collaboration agreement is terminated, we may not receive future milestone payments or royalties under the agreement and our business could be adversely affected.

We are dependent upon Kyowa Kirin for the development, regulatory activities and commercial strategy of ziftomenib outside the United States. Additionally, Kyowa Kirin is responsible for half of all costs and expenses for the commercialization of ziftomenib in the United States. If Kyowa Kirin does not perform in the manner we expect or fulfill its responsibilities in a timely manner, or at all, the clinical development, regulatory approval, and commercialization efforts related to ziftomenib could be delayed or terminated.

Disagreements between us and Kyowa Kirin regarding clinical development and commercialization matters could lead to delays in the development or commercialization of ziftomenib and, in some cases, termination of the Kyowa Agreement. Kyowa Kirin may terminate the Kyowa Agreement for convenience upon 12 months’ prior written notice. In addition, Kyowa Kirin has the right to terminate the Kyowa Agreement with a shorter specified notice period upon the occurrence of a material adverse regulatory event or certain other specified events.

If our collaboration does not result in the successful development and commercialization of ziftomenib, or if Kyowa Kirin terminates the Kyowa Agreement, we may not receive any future milestone or royalty payments under the Kyowa Agreement. In addition, any termination of the Kyowa Agreement by Kyowa Kirin could affect our ability to further develop ziftomenib or adversely affect how we are perceived in scientific and financial communities. If any of these occur, our business, financial condition, results of operations, stock price and prospects may be materially harmed.

We rely on third-party contractors and organizations to conduct, and/or to supply materials to conduct, our clinical trials and provide commercial supply, and those third parties may not perform satisfactorily, including failing to meet deadlines for the supply of materials and/or the completion of such clinical trials or to meet the demands of our commercial supply.

We rely, and expect to continue to rely, on third-party contractors, CROs, clinical data management organizations, independent contractors, medical institutions and clinical investigators to support our preclinical development activities and conduct our clinical trials. These agreements may terminate for a variety of reasons, including a failure to perform by the third parties. If we are required to enter into alternative arrangements, our product development activities could be delayed.

We compete with many other companies, some of which may be our business competitors, for the resources of these third parties. Large pharmaceutical companies often have significantly more extensive agreements and relationships with such third-party providers, and such third-party providers may prioritize the requirements of such large pharmaceutical companies over ours. The third parties on whom we rely may have the right to terminate their engagements with us at any time, which may cause delay in the development and commercialization of our product candidates. If any such third-party terminates its engagement with us or fails to perform as agreed, we may be required to enter into alternative arrangements, which could result in significant cost and delay to our product development program. Moreover, our agreements with such third parties generally do not provide assurances regarding employee turnover and availability, which may cause interruptions in the research on our product candidates by such third parties.

Our reliance on third parties to conduct our clinical trials reduces our control over these activities but does not relieve us of our responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the clinical trial. Moreover, the FDA and other regulatory authorities require us to comply with good clinical practice guidelines 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 clinical trial participants are protected. We are also required to register ongoing clinical trials and post the results of completed clinical trials on government-sponsored databases, such as ClinicalTrials.gov, within specified timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

Additionally, we rely substantially on third-party data managers for our clinical trial data. There is no assurance that these third parties will not make errors in the design, management or retention of our data or data systems. There is no assurance that these third parties will pass FDA or other regulatory audits, which could delay or prevent regulatory approval.

In addition to relying upon third-party service providers, we depend on our collaborators and other third-party suppliers to supply certain therapies for our combination trials. For example, we depend on Mirati to supply adagrasib for the NSCLC combination cohort of our FIT-001 trial. If Mirati does not perform in accordance with our collaboration agreement, or the agreement is terminated, the NSCLC combination cohort of our FIT-001 trial, and our development plans for KO-2806 in combination with adagrasib, could be materially adversely impacted. Similarly, for our KURRENT-HN trial, we depend upon Novartis to supply alpelisib in accordance with the terms of our collaboration agreement. If Novartis does not perform in accordance with the agreement, or the agreement is terminated, the KURRENT-HN trial, and our development plans for tipifarnib in combination with alpelisib, could be materially adversely impacted.

If these third parties do not successfully carry out their contractual duties, meet expected timelines, conduct our clinical trials or supply clinical trial materials in accordance with regulatory requirements, our agreements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates.

In addition, the ability of these third parties to conduct certain of their operations, including monitoring of clinical sites, as applicable, may be limited by actual or threatened public health epidemics or outbreaks, and to the extent that such third parties are unable to fulfill their contractual obligations as a result of such events or government orders in response to such events, we may have limited or no recourse under the terms of our contractual agreements with such third parties. Further, if any of the third parties with whom we engage were to experience shutdowns or other substantial disruptions due to actual or threatened public health epidemics or outbreaks, our ability to conduct our business in the manner and on the timelines presently planned could be materially and negatively affected, which could have a material adverse impact on our business and our results of operation and financial condition.

We depend on third parties for the manufacture of our product candidates for preclinical and clinical testing and expect to continue to do so for commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products at an acceptable cost and quality, which could delay, prevent or impair our development or commercialization efforts.

We do not own or operate facilities for the manufacture of our product candidates and we currently have no plans to build our own clinical or commercial scale manufacturing capabilities. We rely, and expect to continue to rely, on third parties for the manufacture of clinical supplies of ziftomenib, KO-2806 and tipifarnib for preclinical and clinical testing. We expect to rely on third parties as well for commercial manufacture if any of our product candidates receive marketing approval. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts. We also expect to rely on other third parties to package and label the drug product as well as to store and distribute drug supplies for our clinical trials.

The manufacture of pharmaceutical products is complex and requires significant expertise and capital investment, including the development of drug formulation and manufacturing techniques and process controls. Manufacturers of active pharmaceutical ingredients, or APIs, and pharmaceutical products often encounter difficulties in production, particularly in scaling up and validating initial production and absence of contamination. These problems include difficulties with production costs and yields, quality control, including stability of the product, quality assurance testing, operator error, shortages of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations. Furthermore, if contaminants are discovered in our products or in the manufacturing facilities in which our products are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination.

Some of our manufacturers and suppliers are located in China. Trade tensions and conflict between the United States and China have been escalating in recent years and, as such, we are exposed to the possibility of product supply disruption and increased costs and expenses in the event of changes to the laws, rules, regulations, and policies of the governments of the United States or China, or due to geopolitical unrest and unstable economic conditions. Certain Chinese biotechnology companies may become subject to trade restrictions, sanctions, other regulatory requirements, or proposed legislation by the U.S. Government, which could restrict or even prohibit our ability to work with such entities, thereby potentially disrupting their supply of material to us. Such disruption could have adverse effects on the development of our product candidates and our business operations.

If we are unable to develop formulations of our product candidates with acceptable stability and sterility characteristics, or experience an unexpected delay or loss of supply of any of our product candidates for any reason, whether as a result of manufacturing, supply or storage issues, geopolitical events, actual or threatened public health epidemics or outbreaks, or otherwise, our business may be harmed and we may experience delays, disruptions, suspensions or terminations of, or we may be required to restart or repeat, any pending or ongoing clinical trials. Although we generally do not begin a clinical trial unless we believe we have a sufficient supply of a product candidate to complete the clinical trial, we may be required to manufacture additional supplies of our product candidates to the extent our estimates of the amounts required prove inaccurate, we suffer unexpected losses of product candidate supplies, or to the extent that we are required to have fresh product candidate supplies manufactured to satisfy regulatory requirements or specifications. Any significant delay or discontinuation in the supply of a product candidate, or the raw material components thereof, due to the need to replace a supplier, contract manufacturer or other third-party manufacturer, could considerably harm our business and delay completion of our clinical trials, product testing and potential regulatory approval of our product candidates. Any performance failure on the part of our existing or future manufacturers, suppliers or distributors could delay clinical development or marketing approval of our product candidates or commercialization of our products, producing additional losses and depriving us of potential product revenue. If our current contract manufacturers cannot perform as agreed, we may be required to replace such manufacturers. Although we believe that there are several potential alternative manufacturers who could manufacture our product candidates, we may incur added costs and delays in identifying and qualifying any such replacement.

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:

  • reliance on the third party for regulatory compliance and quality assurance;
  • catastrophic events at the third-party organization;
  • the possible breach of the manufacturing agreement by the third party;
  • the possible misappropriation of our proprietary information, including our trade secrets and know-how; and
  • the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

The facilities used by our contract manufacturers to manufacture our product candidates must be approved by the applicable regulatory authorities, including the FDA, pursuant to inspections that will be conducted after an NDA is submitted to the FDA. We are completely dependent on our contract manufacturing partners for compliance with the FDA’s requirements for manufacture of both the active drug substances and finished drug product for ziftomenib, KO-2806, tipifarnib and our other product candidates. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the FDA’s regulatory requirements, they will not be able to secure or maintain FDA approval for the manufacturing facilities. In addition, we have limited control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or any other applicable regulatory authorities does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, or if our suppliers or contract manufacturers decide they no longer want to supply or manufacture our products, we may need to find alternative manufacturing facilities, in which case we might not be able to identify manufacturers for clinical or commercial supply on acceptable terms, or at all, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates. Third-party manufacturers may not be able to comply with cGMP regulations or similar regulatory requirements outside the United States. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products.

Our product candidates and any products that we may develop may compete with other product candidates and products for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us.

We and our collaboration partners have been able to continue to supply our clinical products to our patients and currently do not anticipate any interruptions in supply. To the extent our third-party manufacturers and supply chain suppliers are negatively impacted by geopolitical events such as actual or potential conflicts in the Middle East, Europe or Asia, as well as actual or threatened public health epidemics or outbreaks, we may not be able to provide continuous drug supply to our clinical sites and our clinical trials may be delayed or may not be completed which would have a material adverse effect on our business operations and performance.

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 in some or all planned regions, we will not be able to commercialize, or may be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired.

Our product candidates must be approved by the FDA pursuant to an NDA in the United States. and by the EMA in Europe, and similar regulatory authorities outside the United States prior to commercialization. The process of obtaining marketing approvals, both in the United States and abroad, is expensive and takes many years, 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. In addition, public health epidemics or outbreaks could also potentially affect the business of the FDA, the EMA or other health authorities, which could result in delays in meetings related to planned clinical trials and ultimately of reviews and approvals of our product candidates. Failure to obtain marketing approval for a product candidate will prevent us from commercializing the product candidate. We have not received approval to market any of our product candidates from regulatory authorities in any jurisdiction. We have no experience in filing and supporting the applications necessary to gain marketing approvals and expect to rely on third parties to assist us in this process. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory authorities, among other requirements. Our product candidates may not be effective, may be only moderately effective, may not have an acceptable durability of response, may not have an acceptable risk-benefit profile 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. Regulatory authorities 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 studies, clinical trials 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. 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 also cause delays in or prevent the approval of an application.

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.

A Breakthrough Therapy Designation by the FDA may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval.

We have received Breakthrough Therapy Designation from the FDA on ziftomenib for the treatment of patients with relapsed or refractory NPM1-mutant AML and tipifarnib for the treatment of patients with recurrent or metastatic HRAS-mutant HNSCC with variant allele frequency ≥ 20% after disease progression on platinum-based chemotherapy. A Breakthrough Therapy is defined as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Drugs that have been designated as Breakthrough Therapies are eligible for priority review by the FDA, rolling submission of portions of the NDA and FDA’s organizational commitment involving senior management to provide guidance to the company to help determine the most efficient route to approval. Such interaction and communication between the FDA and the sponsor can help to identify the most efficient path for development. However, the reduced timelines may introduce significant chemistry, manufacturing and controls challenges for product development.

Designation as a Breakthrough Therapy is within the discretion of the FDA. Accordingly, even if we believe that one of our product candidates meets the criteria for designation as a Breakthrough Therapy, the FDA may disagree and instead determine not to make such designation. In any event, the receipt of a Breakthrough Therapy Designation for a product candidate may not result in a faster development process, review or approval compared to drugs considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if one or more of our product candidates qualify as Breakthrough Therapies, the FDA may later decide that such product candidates no longer meet the conditions for qualification and rescind such designations.

Failure to obtain marketing approval in international jurisdictions would prevent our product candidates from being marketed abroad.

In order to market and sell our products in the European Union and many other jurisdictions, we or our third-party collaborators must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing and different criteria for approval. The time required to obtain approval may differ substantially from that required to obtain FDA approval. The regulatory approval process outside the United States generally includes all of the risks associated with obtaining FDA approval. In addition, in many countries outside the United States, it is required that the product be approved for reimbursement before the product can be approved for sale in that country. We or our third-party collaborators may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. However, failure to obtain marketing approval in some countries or jurisdictions may compromise our ability to obtain approval elsewhere. We may not be able to file for marketing approvals and may not receive necessary approvals to commercialize our products in any market.

Any product candidate for which we obtain marketing approval will be subject to extensive post-approval regulatory requirements and could be subject to post-approval restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.

Our product candidates and the activities associated with their development and commercialization, including their testing, manufacture, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA and other regulatory authorities. These requirements include, without limitation, submissions of safety and other post-approval information and reports, registration and listing requirements, cGMP requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, including periodic inspections by the FDA and other regulatory authorities, restrictions or requirements regarding the distribution of samples to physicians, tracking and reporting of payments to physicians and other healthcare providers, and recordkeeping requirements.

The FDA may also impose requirements for costly post-approval studies or clinical trials and surveillance to monitor the safety or efficacy of the product. The FDA closely regulates the post-approval marketing and promotion of drugs to ensure drugs are marketed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA imposes stringent restrictions on manufacturers’ communications regarding use of their products and if we promote our products beyond their approved indications, we may be subject to enforcement action for off-label promotion. Violations of the Federal Food, Drug and Cosmetic Act relating to the promotion of prescription drugs may lead to investigations alleging violations of federal and state healthcare fraud and abuse laws, as well as state consumer protection laws.

In addition, later discovery of previously unknown adverse events or other problems with our products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may yield various results, including:

  • restrictions on such products, manufacturers or manufacturing processes;
  • restrictions on the labeling or marketing of a product;
  • restrictions on product distribution or use;
  • requirements to conduct post-approval studies or clinical trials;
  • warning or untitled letters;
  • withdrawal of the products from the market;
  • refusal to approve pending applications or supplements to approved applications that we submit;
  • recall of products;
  • fines, restitution or disgorgement of profits or revenues;
  • suspension or withdrawal of marketing approvals;
  • refusal to permit the import or export of our products;
  • product seizure; or
  • injunctions or the imposition of civil or criminal penalties.

Non-compliance with European Union requirements regarding safety monitoring or pharmacovigilance, and with requirements related to the development of products for the pediatric population, can also result in significant financial penalties. Similarly, failure to comply with the European Union’s requirements regarding the protection of personal data can also lead to significant penalties and sanctions.

The FDA and other regulatory agencies may require more extensive or expensive trials for combination product candidates than may be required for single agent pharmaceuticals.

In the event that we seek regulatory approval for a combination product candidate, we may be required to show that each candidate drug product component makes a contribution to the combination regimen’s claimed effects and that the dosage of each component, including amount, frequency and duration, is such that the combination is safe and effective for a significant patient population requiring such concurrent therapy. As a result, we may be required to conduct clinical trials comparing each component drug with the combination. This could require us to conduct more extensive and more expensive clinical trials than would be the case for many single agent pharmaceuticals. The need to conduct such trials could make it more difficult and costly to obtain regulatory approval of a combination drug than of a new drug containing only a single API.

We may not be able to benefit from available regulatory exclusivity periods for tipifarnib if another company obtains regulatory approval for tipifarnib before we do.

The composition of matter patents covering tipifarnib expired in the United States and in countries in Europe in 2016. Our commercial strategy for tipifarnib relies on obtaining method of use and method of treatment patents, including those directed to specific indications and biomarkers, other patents related to tipifarnib, and method of treatment patents related to farnesyl transferase inhibitors including tipifarnib, and on non-patent regulatory exclusivity. In the United States, a pharmaceutical manufacturer may obtain five years of non-patent exclusivity upon FDA approval of an NDA for a new chemical entity, or NCE, which is a drug that contains an active moiety that has not been approved by the FDA in any other NDA. An “active moiety” is defined as the molecule or ion responsible for the drug substance’s physiological or pharmacologic action. During the five-year exclusivity period, the FDA cannot accept for filing any abbreviated new drug application seeking approval of a generic version of that drug or any Section 505(b)(2) NDA for the same active moiety and that relies on the FDA’s findings regarding that drug, except that the FDA may accept an application for filing after four years if the follow-on applicant makes a paragraph IV certification.

We may not be able to obtain orphan drug exclusivity for the product candidates for which we seek it, which could limit the potential profitability of such product candidates.

Regulatory authorities in some jurisdictions, including the United States and Europe, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the United States. Generally, if a product with an orphan designation subsequently receives the first marketing approval for the indication for which it receives the designation, then the product is entitled to a period of marketing exclusivity that precludes the applicable regulatory authority from approving another marketing application for the same drug for the same indication during the exclusivity period. The applicable period is seven years in the United States and ten years in Europe. The European exclusivity period can be reduced to six years if a drug no longer meets the criteria for orphan designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified. Orphan drug exclusivity may be lost if the FDA or EMA determines that the request for designation was materially defective, or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.

In July 2019, the FDA granted orphan drug designation to ziftomenib for the treatment of AML. If ziftomenib receives marketing approval for an indication broader than AML, ziftomenib may no longer be eligible for marketing exclusivity. Furthermore, orphan drug exclusivity may not effectively protect ziftomenib from the competition of different drugs for the same orphan condition, which could be approved during the exclusivity period. Additionally, after an orphan drug is approved, the FDA could subsequently approve another application for the same drug for the same condition if the FDA concludes that the later drug is shown to be safer, more effective or makes a major contribution to patient care. The failure to obtain an orphan designation for any product candidates we may develop for the treatment of rare cancers, and/or the inability to maintain that designation for the duration of the applicable exclusivity period, could reduce our ability to make sufficient sales of the applicable product candidate to balance our expenses incurred to develop it, which would have a negative impact on our operational results and financial condition.

If we obtain an orphan designation and FDA approval of any of our product candidates for an oncology indication, we would be entitled to seven years of marketing exclusivity for that orphan indication. However, if a competitor obtained approval of a generic form of such product candidate for another indication, physicians would not be prevented from prescribing the generic drug for the orphan indication during the period of marketing exclusivity. Such prescribing practices could adversely affect the sales of our product candidates for the orphan indication.

Our relationships with healthcare professionals, customers and third-party payors and our general business operations may be subject to applicable fraud and abuse laws, including anti-kickback and false claims laws, transparency laws, privacy laws and other healthcare laws and regulations, which could expose us to significant penalties, including criminal sanctions, administrative and civil penalties, contractual damages, reputational harm and diminished profits and future earnings, among other penalties.

Healthcare providers and third-party payors will 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 providers, 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 any products for which we obtain marketing approval. Restrictions under applicable federal and state healthcare laws and regulations include the following:

  • the federal Anti-Kickback Statute, which prohibits, among other things, individuals and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, 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 a federal healthcare program such as Medicare and Medicaid;

  • the federal civil and criminal false claims laws, including the civil False Claims Act, which can be enforced by private citizens, on behalf of the government, through whistleblower actions, and civil monetary penalties laws which prohibits, among other things, individuals and entities from 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;

  • HIPAA, which imposes criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

  • HIPAA, as amended by HITECH, and their implementing regulations, which also impose obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of protected health information on covered entities which include certain healthcare providers, health plans and healthcare clearinghouses, and their business associates that create, receive, maintain, or transmit protected health information in connection with providing a service for or on behalf of a covered entity as well as their covered subcontractors;

  • the federal Physician Payments Sunshine Act, which requires applicable manufacturers of certain drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to report annually to CMS information related to payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, as well as certain manufacturers and group purchasing organizations to report annually ownership and investment interests held by physicians or their immediate family; and

  • analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which 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 and may require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures, and/or drug pricing. Some state and local laws also require the registration of pharmaceutical sales representatives.

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices may 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 are 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, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, exclusion from government funded healthcare programs, such as Medicare and Medicaid, contractual damages, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our operations. If any of the physicians or other healthcare providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

We and the third parties with whom we work are subject to stringent and evolving U.S. and foreign laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations (or such failure by the third parties with whom we work) could lead to regulatory investigations or actions; litigation (including class claims) and mass arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse business consequences.

In the ordinary course of business, we collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share, or collectively, process personal data, including data we collect about participants in our clinical trials, and other sensitive information, including proprietary and confidential business data, trade secrets, intellectual property, sensitive third-party data, business plans, transactions, and financial information (collectively, sensitive data). 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 data privacy and security laws, including data breach notification laws, personal data privacy laws, consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), and other similar laws (e.g., wiretapping laws). For example, HIPAA, as amended by HITECH, imposes specific requirements relating to the privacy, security, and transmission of individually identifiable health information. Numerous U.S. 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. 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 of 2018, as amended by the California Privacy Rights Act of 2020, or collectively CCPA, applies to personal data of consumers, business representatives, and employees who are California residents, and requires covered businesses to provide specific disclosures in privacy notices and honor requests of such individuals to exercise certain privacy rights. The CCPA provides for fines and allows private litigants affected by certain data breaches to recover significant statutory damages. Although the CCPA and other state laws exempt some data processed in the context of clinical trials, these developments may increase compliance costs and potential liability. Similar laws are being considered in several other states. In addition, data privacy and security laws have been proposed at the federal and local levels in recent years, which could further complicate compliance efforts.

Outside the United States, an increasing number of laws, regulations, and industry standards govern data privacy and security. For example, the EU GDPR and the United Kingdom’s GDPR, or UK GDPR (collectively, GDPR), and Australia's Privacy Act impose strict requirements for processing personal data. For example, under 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. The Personal Information Protection and Electronic Documents Act and various related provincial laws, as well as Canada’s Anti-Spam Legislation, apply to clinical trials conducted in Canada. Clinical trials conducted in Asia are and may in the future be subject to existing, new and emerging data privacy regimes in that region.

In addition, we may be unable to transfer personal data from Europe and other jurisdictions to the United States or other countries due to data localization requirements or limitations on cross-border data flows. 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 European Economic Area, or EEA, and the United Kingdom, or 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 have in the past and may in the future adopt 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 activities groups. Some European regulators have ordered certain companies to suspend or permanently cease certain transfers of personal data out of Europe for allegedly violating the GDPR’s cross-border data transfer limitations.

In addition to data privacy and security laws, we are bound by certain contractual obligations related to data privacy and security, and our efforts to comply with such obligations may not be successful. We publish privacy policies, materials, and other statements regarding data privacy and security. Regulators in the United States have scrutinized and are increasingly scrutinizing these statements, and if these policies, materials, or 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 expectations) are quickly changing, becoming increasingly stringent, and creating uncertainty. Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions. Preparing for and complying with these obligations requires us to devote significant resources and has 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.

We may at times fail (or be perceived to have failed) in our efforts to comply with our data privacy and security obligations. Moreover, despite our efforts, our personnel or third parties with whom we work may fail to comply with such obligations, which could negatively impact our business operations. If we or the third parties with whom we work fail, or are perceived to have failed, to address or comply with applicable data privacy and security obligations, we could face significant consequences including, but not limited to, government enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar); litigation (including class-action 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 imprisonment of company officials. In particular, plaintiffs have become increasingly more 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, as relevant, 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 revision or restructuring of our operations.

Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain.

In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any product candidates for which we obtain marketing approval.

For example, in March 2010, President Obama signed into law the ACA, a sweeping law intended to broaden access to health insurance, improve quality, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms. With regard to pharmaceutical products, among other things, the ACA expanded and increased industry rebates for drugs covered under Medicaid programs and made changes to the coverage requirements under the Medicare prescription drug benefit.

There have been executive, judicial and Congressional challenges and amendments to certain aspects of the ACA. It is possible that the ACA will be subject to judicial or Congressional challenges in the future. We cannot predict the ultimate content, timing or effect of healthcare reform legislation or regulation or the impact of potential legislation or regulation on us.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. These changes included aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, starting in 2013, that due to subsequent legislative amendments, will stay in effect until 2032. Additionally, in March 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminated the statutory Medicaid drug rebate cap, previously set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, effective January 1, 2024. These laws and other potential legislation may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on customers for our drugs, if approved, and accordingly, our financial operations.

Further, recently there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products. As a result, there have been several recent U.S. Presidential executive orders, Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the cost of drugs under Medicare, and reform government program reimbursement methodologies for drug products. For example, in August 2022, President Biden signed the IRA into law. The IRA, among other things, (1) extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025, (2) directs HHS to negotiate, subject to a specified cap, the price of a set number of certain high-expenditure, single-source drugs covered under Medicare that have been on the market for at least seven years, or Medicare Drug Price Negotiation Program, (3) imposes rebates under Medicare Part B and Medicare Part D to penalize manufacturers for price increases that outpace inflation, and (4) makes several changes to the Medicare Part D benefit, including by significantly lowering the beneficiary maximum annual out-of-pocket costs, and through a change in manufacturer liability under the program. These provisions began to take effect progressively in fiscal year 2023, although the Medicare Drug Price Negotiation Program is currently subject to legal challenges. In August 2024, HHS announced the agreed-upon prices of the first ten drugs that were subject to price negotiations. The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. HHS has issued, and will continue to issue and update, guidance as these programs are implemented. On January 17, 2025, HHS selected 15 additional products covered under Part D for price negotiation in 2025. Each year thereafter more Part B and Part D products will become subject to the Medicare Drug Price Negotiation Program. Further, in December 2023, the Biden administration announced an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act. In December 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights. While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, in January 2024, the FDA approved Florida’s SIP proposal to import certain drugs from Canada for specific state healthcare programs. It is unclear how this program will be implemented, including which drugs will be chosen, and whether it will be subject to legal challenges in the United States or Canada. Other states have also submitted SIP proposals that are pending review by the FDA. Any such approved importation plans, when implemented, may result in lower drug prices for products covered by those programs. Future legislation could potentially change drug pricing dynamics. We cannot predict all of the ways in which future healthcare reform legislation or regulation could affect our business, particularly in light of the 2024 U.S. Presidential and Congressional elections.

We expect that healthcare reform measures that have been adopted and may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products.

Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We cannot be sure whether additional legislative changes will be enacted, or whether FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be. Foreign legislative changes may also affect our ability to commercialize our product candidates.

Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.

In some countries, particularly the countries of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. If reimbursement for our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed, possibly materially.

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 harm 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 for failure to comply with such laws and regulations.

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 and a pollution liability policy, this insurance may not provide adequate coverage against potential liabilities. Other than our pollution liability policy, we do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous or radioactive materials.

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 discovery, preclinical development or production efforts. Our failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Risks Related to Our Intellectual Property

If we are unable to, or if we do not, obtain and maintain intellectual property protection for our product candidates, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our product candidates may be impaired.

We intend to rely upon a combination of regulatory exclusivity periods, patents, trade secret protection, trademarks, confidentiality agreements, and license agreements to protect the intellectual property related to our current product candidates and development programs.

Threats to the duration, breadth or strength of protection provided by any patents, patent applications or future patents we may own, license, or pursue with respect to any of our current or future product candidates or products could hinder our ability to commercialize any of our current or future product candidates or products. For example, our patent rights may not protect our products and product candidates if competitors devise products that compete with us without legally infringing our patent rights. Further, if we encounter delays in our development efforts, the length of time during which we could market any of our current or future product candidates or products under any patent protection we obtain would be reduced. Given the amount of time required for the development, testing and regulatory review of new product candidates or products, patents protecting such candidates might expire before or shortly after such product candidates or products are commercialized.

Ziftomenib

We have issued patents in the United States, Europe, China, Japan and other foreign jurisdictions covering the composition of matter of ziftomenib and certain structurally related compounds and methods of using the compounds for treating cancers. Although these patents are currently in force, there is no guarantee that a court would agree that any of the patents are valid or enforceable.

We are pursuing additional U.S. and foreign patents for ziftomenib; however, there is no guarantee that any such patents will be granted or that, if granted, would provide protection against third parties.

Patent term extension may be available in the United States or in other jurisdictions to account for regulatory delays in obtaining marketing approval for a product candidate; however, in the United States, only one patent may be extended per marketed product. The applicable authorities, including the U.S. PTO and the FDA, and any equivalent patent or regulatory authorities in other countries, may disagree with our assessment of whether such extensions are available, and may refuse to grant extensions to patents, or may grant more limited extensions than requested. If this occurs, for example, for our ziftomenib API patent(s), our competitors who obtain the requisite regulatory approval could offer products with the same API as ziftomenib earlier than expected, so long as the competitors do not infringe any other patents that we may hold. Competitors may take advantage of our investment in development and clinical trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case.

We expect that following expiration of patents and any regulatory exclusivity we are able to obtain for ziftomenib, competitors may manufacture and sell generic versions of ziftomenib at a lower price, which would reduce our ziftomenib revenues. In certain jurisdictions, legislation mandates generic substitution for brand name drugs.

KO-2806

We have filed patent applications in the United States, Europe, China, Japan and other foreign jurisdictions covering the composition of matter of KO-2806 and certain structurally related compounds and methods of using KO-2806 for treating cancers. However, there is no guarantee that patents will be granted from such applications or that any granted patents would provide protection against third parties.

Tipifarnib

Our patent rights in tipifarnib are limited in ways that affect our ability to exclude third parties from competing against us. In particular, the patent term for the composition of matter patents covering the API of tipifarnib expired in 2016. Composition of matter patents on APIs are generally considered to be the strongest form of intellectual property protection because such patents provide protection without regard to any particular method of use or manufacture or formulation of the API used.

Patents directed to the method of treatment of certain cancers using tipifarnib or a farnesyl transferase inhibitor have been issued to us in a number of jurisdictions, including the United States, Europe, China and Japan. Although these patents are currently in force, there is no guarantee that a court would agree that any of the patents are valid or enforceable. Further, if a competitor were to develop tipifarnib for use in an indication other than those claimed by our patents, we would not be able to prevent the competitor from marketing tipifarnib for such indication in the United States or other jurisdictions based on our currently issued patents. We are pursuing additional U.S. and foreign method of treatment patents for tipifarnib and farnesyl transferase inhibitors; however, there is no guarantee that any such patents will be granted or that and granted patents would provide protection against third parties.

While patent term extension may be available for a patent that covers an approved tipifarnib product, the applicable authorities, including the U.S. PTO and the FDA, and any equivalent patent or regulatory authorities in other countries, may disagree with our assessment of whether such extensions are available, and may refuse to grant extensions to patents, or may grant more limited extensions than requested. If this occurs, for example, for our tipifarnib method of use patents, our competitors who obtain the requisite regulatory approval could offer tipifarnib products for the same indication(s) as our tipifarnib product earlier than expected, so long as the competitors do not infringe any other patents that we may hold. Competitors may take advantage of our investment in development and clinical trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case.

We expect that following expiration of patents and any regulatory exclusivity we are able to obtain, competitors may manufacture and sell generic versions of tipifarnib, at a lower price, which would reduce tipifarnib’s revenues. In certain jurisdictions, legislation mandates generic substitution for brand name drugs.

We depend on our licensors to prosecute and maintain patents and patent applications that are material to our business. Any failure by our licensors to effectively protect these intellectual property rights could adversely impact our business and operations.

We have licensed patent rights from third parties for some of our development programs, including compounds in our menin-KMT2A program from the University of Michigan and methods of use of tipifarnib from Memorial Sloan Kettering Cancer Center. As a licensee of third parties, we rely on these third parties to file and prosecute patent applications and maintain patents and otherwise protect the licensed intellectual property under some of our license agreements. We have not had and do not have primary control over these activities for certain of our patents or patent applications and other intellectual property rights. We cannot be certain that such activities by third parties have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents or other intellectual property rights. Pursuant to the terms of the license agreements with some of our licensors, the licensors may have the right to control enforcement of our licensed patents or defense of any claims asserting the invalidity of these patents and even if we are permitted to pursue such enforcement or defense, we will require the cooperation of our licensors. We cannot be certain that our licensors will allocate sufficient resources or prioritize their or our enforcement of such patents or defense of such claims to protect our interests in the licensed patents. Even if we are not a party to these legal actions, an adverse outcome could harm our business because it might prevent us from continuing to license intellectual property that we may need to operate our business.

If we breach any of the agreements under which we license from third parties the development and/or commercialization rights to our product candidates, we could lose license rights that are important to our business and our operations could be materially harmed.

We have in-licensed rights to ziftomenib and other compounds in our menin-KMT2A program from the University of Michigan. We have also in-licensed from Janssen use, development and commercialization rights for tipifarnib in all indications other than virology. Additionally, we have an exclusive worldwide license from Memorial Sloan Kettering Cancer Center to a patent family pertaining to a method of use of FTIs, including tipifarnib. As a result, our current business plans are dependent upon our satisfaction of certain conditions for the maintenance of the University of Michigan license agreement and the Janssen license agreement and the rights we license under such agreements and our other in-license agreements. The University of Michigan license agreement and the Janssen license agreement each provides that we are subject to diligence obligations relating to the commercialization and development of the respective product candidates, milestone payments, royalty payments and other obligations. If we fail to comply with any of the conditions or obligations or otherwise breach the terms of our license agreement with University of Michigan, or Janssen, or any of our other license agreements or license agreements we may enter into on which our business or product candidates are dependent, University of Michigan, or Janssen, or other licensors may have the right to terminate the applicable agreement in whole or in part and thereby extinguish our rights to the licensed technology and intellectual property and/or any rights we have acquired to develop and commercialize certain product candidates. The loss of the rights licensed to us under our license agreement with University of Michigan, or Janssen, or our other license agreements or any future license agreement that we may enter granting us rights on which our business or product candidates are dependent, would eliminate our ability to further develop the applicable product candidates and would materially harm our business, prospects, financial condition and results of operations.

Disputes may arise regarding intellectual property subject to, and any of our rights and obligations under, any license or other strategic agreement, including:

  • the scope of rights granted under the license agreement and other interpretation-related issues;
  • the extent to which our technology and processes infringe, misappropriate or violate the intellectual property of the licensor that is not subject to the license agreement;
  • our diligence obligations under the license agreement and what activities satisfy those diligence obligations;
  • the sublicensing of patent and other rights to third parties under any such agreement or collaborative relationships;
  • the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and
  • the priority of invention of patented technology.

In addition, the agreements under which we license intellectual property or technology to or from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.

The patent applications of pharmaceutical and biotechnology companies involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our patent position.

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. Certain inventions that are patentable in the United States may not be patentable in other countries and vice versa. Further, our ability to enforce our patent rights in foreign jurisdictions may not be as effective as in the United States. For example, some foreign countries, such as India and China, may not allow or enforce patents for methods of treating the human body. Publications of discoveries in the 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 or our licensors were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we or our licensors were the first to file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. 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 or eliminate our patent protection completely.

Moreover, we may be subject to a third-party preissuance submission of prior art to the U.S. PTO or third-party preissuance observations to the European Patent Office, or EPO, or become involved in patent office post-grant proceedings, such as opposition, derivation, reexamination, inter partes review, or post-grant review proceedings, challenging our patent rights or the patent rights of others. An adverse determination in any such submission or proceeding, or in 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, threats to the duration, breadth or strength of protection provided by our patents and patent applications is threatened could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

Even if our owned and licensed patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Even if our owned and licensed patents might provide such protection or competitive advantage, we may not have the resources to effectively enforce our rights under such patents, which can be expensive and time-consuming. Further, our competitors may be able to circumvent our owned or licensed patents by developing similar or alternative technologies or products in a non-infringing manner.

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 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. 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.

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

As is the case with other pharmaceutical companies, our success depends heavily on intellectual property, particularly patents. Obtaining and enforcing patents in the pharmaceutical industry involve a high degree of technological and legal complexity. Therefore, obtaining and enforcing pharmaceutical patents is costly, time consuming and inherently uncertain. Changes in either the patent laws or in the interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property and may increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. We cannot predict the breadth of claims that may be allowed or enforced in our patents or in third-party patents. In addition, Congress or other foreign legislative bodies may pass patent reform legislation that is unfavorable to us.

For instance, under the Unitary Patent Court system that has been implemented in Europe, patent applicants have the option, upon grant of a patent by the EPO, of electing grant of a Unitary Patent, which will be subject to the jurisdiction of the Unified Patent Court, or UPC. This is a significant change in European patent practice. As the UPC is a new court system, there is limited precedent for the court, increasing the uncertainty of any litigation.

Patent terms may be inadequate to protect our competitive position on our product candidates for a commercially meaningful length of time.

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its effective U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are obtained, once the patents have expired, we may be open to competition from competitive 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 patent portfolio may not provide us with sufficient duration of rights to exclude others from commercializing products similar or identical to ours.

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

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications are due to be paid to the U.S. PTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and/or applications. We have systems in place to remind us to pay these fees, and we employ an outside annuity provider firm and/or rely on our outside counsel to pay the fees due to patent agencies. The U.S. PTO and various non-U.S. governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. We employ reputable law firms and other professionals to help us comply, and 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. However, there are situations in which non-compliance 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. In such an event, our competitors might be able to enter the market and this circumstance would have a material adverse effect on our business.

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

Because competition in our industry is intense, competitors may infringe or otherwise violate our issued patents, patents of our licensors or other intellectual property. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming to pursue. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patents. In addition, in a patent infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or 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 proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly. We may also elect to enter into license agreements in order to settle patent infringement claims or to resolve disputes prior to litigation, and any such license agreements may require us to pay royalties and other fees that could be significant. 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.

Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.

Our commercial success depends upon our ability, and the ability of our collaborators, to develop, manufacture, market and sell our product candidates and use our proprietary technologies without infringing the proprietary rights of third parties. There is considerable intellectual property litigation in the biotechnology and pharmaceutical industries. We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our products and technology, including derivation, reexamination, inter partes review, post-grant review or interference proceedings before the U.S. PTO. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future.

If we are found to infringe a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue developing and marketing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, we could be found liable for monetary damages, including treble damages and attorneys’ fees if we are found to have willfully infringed a patent. A finding of infringement could prevent us from commercializing our product candidates or force us to cease some of our business operations, which could materially harm our business. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.

We may not be successful in obtaining or maintaining necessary third-party intellectual property rights for our development pipeline through acquisitions and in-licenses.

Presently we have rights to intellectual property under an exclusive worldwide license from the University of Michigan for all therapeutic indications for ziftomenib and other compounds in our menin-KMT2A program, an exclusive license from Janssen to develop tipifarnib in all fields other than virology, and an exclusive worldwide license from Memorial Sloan Kettering Cancer Center to a patent family pertaining to a method of use of FTIs, including tipifarnib. Because our programs may involve additional product candidates that may require the use of proprietary rights held by third parties, the growth of our business may depend in part on our ability to acquire, in-license or use these proprietary rights. Additionally, a companion diagnostic may require that we or a third-party collaborator developing the diagnostic acquire proprietary rights held by third parties, which may not be available. We may be unable to acquire or in-license any compositions, methods of use, or other third-party intellectual property rights from third parties that we identify. The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies are also pursuing strategies to license or acquire third-party intellectual property rights that we may consider attractive. These established companies may have a competitive advantage over us due to their size, cash resources and greater clinical development and commercialization capabilities.

For example, we may collaborate with U.S. and foreign academic and other research institutions to accelerate our discovery and preclinical development work under written agreements with these institutions. Typically, these institutions provide us with an option to negotiate a license to any of the institution’s rights in technology resulting from the collaboration. Regardless of such right of first negotiation for intellectual property, we may be unable to negotiate a license within the specified time frame or under terms that are acceptable to us. If we are unable to do so, the institution may offer the intellectual property rights to other parties, potentially blocking our ability to pursue our program.

In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment. If we are unable to successfully obtain rights to required third-party intellectual property rights, our business, financial condition and prospects for growth could suffer.

If we are unable to maintain the confidentiality of our trade secrets or other confidential information, our business and competitive position would be harmed.

In addition to seeking patents for some of our technology and product candidates, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position. We seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. We seek to protect our confidential proprietary information, in part, by entering into confidentiality and invention or patent assignment agreements with our employees and consultants; however, we cannot be certain that such agreements have been entered into with all relevant parties. Moreover, to the extent we enter into such agreements, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, to third parties, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent the competitor, or those to whom the competitor communicates the trade secrets, from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position would be harmed.

Intellectual property discovered through government-funded programs may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for use of U.S.-based manufacturing companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.

Although we do not currently own issued patents or pending patent applications that have been generated through the use of U.S. government funding, our exclusive licenses from Memorial Sloan Kettering Cancer Center to a patent family pertaining to a method of use of FTIs, including tipifarnib, and from the University of Michigan pertaining to compounds unrelated to ziftomenib include intellectual property rights that have been generated through the use of U.S. government funding or grants, and we may acquire or license additional intellectual property rights from one or more entities that have been generated through the use of U.S. government funding or grants. Pursuant to the Bayh-Dole Act, the U.S. government has certain rights in inventions developed with government funding. These U.S. government rights include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. In addition, the U.S. government has the right, under certain limited circumstances, to require us to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third party if it determines that: (1) adequate steps have not been taken to commercialize the invention; (2) government action is necessary to meet public health or safety needs; or (3) government action is necessary to meet requirements for public use under federal regulations (also referred to as “march-in rights”). If the U.S. government exercised its march-in rights in our intellectual property rights generated through the use of U.S. government funding or grants, we could be forced to license or sublicense intellectual property developed by us or that we license on terms unfavorable to us, and there can be no assurance that we would receive compensation from the U.S. government for the exercise of such rights. The U.S. government also has the right to take title to these inventions if the grant recipient fails to disclose the invention to the government or fails to file an application to register the intellectual property within specified time limits. Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance with which may require us to expend substantial resources. In addition, the U.S. government requires that any products embodying any of these inventions or produced through the use of any of these inventions be manufactured substantially in the United States. This preference for U.S. industry may be waived by the federal agency that provided the funding if the owner or assignee of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible. This preference for U.S. industry may limit our ability to contract with non-U.S. product manufacturers for products covered by such intellectual property.

We may not be able to protect our intellectual property rights throughout the world.

Geo-political actions in the United States and in foreign countries could increase the uncertainties and costs surrounding the prosecution or maintenance of our patent applications or those of any current or future licensors and the maintenance, enforcement or defense of our issued patents or those of any current or future licensors. For example, the U.S. and foreign government actions related to Russia’s invasion of Ukraine may limit or prevent filing, prosecution, and maintenance of patent applications in Russia. Government actions may also prevent maintenance of issued patents in Russia. These actions could result in abandonment or lapse of our patents or patent applications, resulting in partial or complete loss of patent rights in Russia. In addition, a decree was adopted by the Russian government in March 2022, allowing Russian companies and individuals to exploit inventions owned by patentees from the United States without consent or compensation. Consequently, we would not be able to prevent third parties from practicing our inventions in Russia or from selling or importing products made using our inventions in and into Russia. Accordingly, our competitive position may be impaired, and our business, financial condition, results of operations and prospects may be adversely affected.

Risks Related to the Commercialization of Our Product Candidates

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.

If any of our product candidates receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. For example, current cancer treatments like immunotherapy, chemotherapy, targeted therapy and radiation therapy are well established in the medical community, and doctors may continue to rely on these treatments to the exclusion of our product candidates. If our product candidates do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable. The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including:

  • the efficacy and safety and potential advantages and disadvantages compared to alternative treatments;
  • our ability to offer our products for sale at competitive prices;
  • the convenience and ease of administration compared to alternative treatments;
  • the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
  • the strength of our marketing and distribution support;
  • the availability of third-party coverage and adequate reimbursement, including patient cost-sharing programs such as copays and deductibles;
  • our ability to develop or partner with third-party collaborators to develop companion diagnostics;
  • the acceptance and utilization of diagnostics to identify appropriate patients;
  • the prevalence and severity of any side effects; and
  • any restrictions on the use of our products together with other medications.

We currently have limited marketing, sales and distribution infrastructure. If we are unable to fully develop our sales capabilities or enter into agreements with third parties to sell or market our product candidates if they obtain regulatory approval, we may not be able to effectively sell or market our product candidates, if approved, or generate product revenues.

We are in the process of building our marketing, sales and distribution capabilities. In preparation for potential FDA approval of ziftomenib in patients with relapsed or refractory NPM1-mutant AML, we are building on a territory-by-territory basis sales, marketing, distribution, managerial and other non-technical capabilities or making arrangements with third parties to perform these services, and we may not be successful in doing so. We have expanded our sales, marketing, analytics and market access teams with expertise to commercialize our product candidates. The onboarding and training of these teams, and the development of our commercial capabilities and infrastructure, is expensive and time consuming and requires significant attention of our executive officers to manage. Any failure or delay in the development of our commercial capabilities and infrastructure would adversely impact the commercialization of any of our products that we obtain approval to market. Additionally, if the commercial launch of any product candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly and our investment would be lost if we cannot retain or reposition such sales

and marketing personnel. With respect to the commercialization of all or certain of our product candidates, we may choose to collaborate, either globally or on a territory-by-territory basis, with third parties that have direct sales forces and established distribution systems, either to augment our own sales force and distribution systems or in lieu of our own sales force and distribution systems. For example, under the Kyowa Agreement, we are collaborating with Kyowa Kirin for the potential commercialization of ziftomenib in certain indications. If we are unable to enter into similar arrangements for ziftomenib in indications outside the Kyowa Agreement or for other product candidates when needed on acceptable terms or at all, we may not be able to successfully commercialize such product candidates that receive regulatory approval or any such commercialization may experience delays or limitations. If we are not successful in commercializing our product candidates, either on our own or through collaborations with one or more third parties, our future product revenue will suffer and we may incur significant additional losses.

We face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do.

The development and commercialization of new drug products is highly competitive. We face competition with respect to our current product candidates, and we will face competition with respect to any product candidates that we may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of products for the treatment of the disease indications for which we are developing our product candidates. Some of these competitive products and therapies are based on scientific approaches that are the same as or similar to our approach, and others are based on entirely different approaches. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

Specifically, there are a large number of companies developing or marketing treatments for cancer, including many major pharmaceutical and biotechnology companies, which may directly compete with ziftomenib, KO-2806, tipifarnib and any other future product candidates. If any competitor is able to advance their clinical program more quickly than ours, the commercial opportunity for our product candidates could be reduced. In the case of ziftomenib, in November 2024, Syndax announced the FDA’s approval of revumenib (Revuforj®) in relapsed or refractory KMT2A-rearranged acute leukemia. Earlier this year, they announced that they expect to submit a supplemental NDA for revumenib in relapsed or refractory NPM1-mutant AML in the first half of 2025, followed by a potential FDA approval around year-end 2025.

Our commercial opportunity also 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 than any products that we may develop alone or in combination with other drugs or biologics. 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 before we are able to enter the market or slow our regulatory approval and ability to sell our products. In addition, our ability to compete may be affected in many cases by insurers or other third-party payors seeking to encourage the use of generic products or prioritize the use of other branded products over our products.

Many of the companies against which we are competing or against which we may compete in the future have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

The insurance coverage and reimbursement status of newly-approved products are uncertain. Failure to obtain or maintain coverage and adequate reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue.

The availability and extent of coverage and reimbursement by governmental and private payors is essential for most patients to be able to afford expensive treatments. Sales of our product candidates will depend substantially, both domestically and abroad, on the extent to which the costs of our product candidates will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration authorities, private health coverage insurers and other third-party payors. If reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize our product candidates. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investment. Further, coverage policies and third-party payor reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we receive marketing approval, less favorable coverage policies and reimbursement rates may be implemented in the future. Further, any companion diagnostic that we or our collaborators develop will be subject to separate coverage and reimbursement determinations by third-party payors.

There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. In the United States, the principal decisions about government-funded reimbursement for new medicines are typically made by CMS, an agency within HHS, as CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare. Private payors often, but not always, follow CMS’s decisions regarding coverage and reimbursement. It is difficult to predict what CMS will decide with respect to coverage and reimbursement for fundamentally novel products such as ours, as there is no body of established practices and precedents for these new products. One payor’s determination to provide coverage for a drug product does not assure that other payors will also provide coverage for the drug product. Further, a payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. We or our collaborators may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of our products, in addition to the costs required to obtain FDA approvals. Nonetheless, our product candidates may not be considered medically necessary or cost-effective.

Reimbursement agencies in countries other than the United States may be more conservative than CMS. For example, a number of cancer drugs have been approved for reimbursement in the United States and have not been approved for reimbursement in certain European countries. Outside the United States, international operations are generally subject to extensive governmental price controls and other market regulations, and we believe the increasing emphasis on cost-containment initiatives in Europe, Canada, and other countries has and will continue to put pressure on the pricing and usage of our product candidates. 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 our products may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenues and profits.

Moreover, increasing efforts by governmental and third-party payors, in the United States and abroad, to cap or reduce healthcare costs may cause such organizations to limit both coverage and level of reimbursement for new products approved and, as a result, they may not cover or provide adequate payment for our product candidates. In addition, drug-pricing by pharmaceutical companies has come under increased scrutiny. Specifically, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing by requiring drug companies to notify insurers and government regulators of price increases and provide an explanation of the reasons for the increase, reduce the out-of-pocket cost of prescription drugs, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for drugs. We expect to experience pricing pressures in connection with the sale of any of our product candidates, due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products into the healthcare market.

In addition to CMS and private payors, professional organizations such as the National Comprehensive Cancer Network and the American Society of Clinical Oncology can influence decisions about reimbursement for new medicines by determining standards for care. In addition, many private payors contract with commercial vendors who sell software that provide guidelines that attempt to limit utilization of, and therefore reimbursement for, certain products deemed to provide limited benefit to existing alternatives. Such organizations may set guidelines that limit reimbursement or utilization of our products.

Further, we or our collaborators will be required to obtain coverage and reimbursement for companion diagnostic tests separate and apart from the coverage and reimbursement we seek for our product candidates, once approved. There is significant uncertainty regarding our and our collaborators’ ability to obtain coverage and adequate reimbursement for any companion diagnostic test for the same reasons applicable to our product candidates. If insurance coverage and reimbursement for companion diagnostic tests for our product candidates is inadequate, utilization may be low, and patient tumors may not be comprehensively screened for the presence of the genetic markers that predict response to our product candidates.

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:

  • decreased demand for any product candidates or products that we may develop;
  • injury to our reputation and significant negative media attention;
  • withdrawal of clinical trial participants;
  • significant costs to defend the related litigation;
  • substantial monetary awards to clinical trial participants or patients;
  • loss of revenue;
  • reduced resources of our management to pursue our business strategy; and
  • the inability to commercialize any products that we may develop.

Our current product liability insurance coverage may not be adequate to cover all liabilities that we may incur. We may need to increase our insurance coverage as we expand 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 Employee Matters, Managing Growth and Macroeconomic Conditions

We are highly dependent on our Chief Executive Officer. Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.

We are highly dependent on the expertise of Troy E. Wilson, Ph.D., J.D., our President and Chief Executive Officer, as well as the other principal members of our management, scientific and clinical teams. Although we have entered into employment letter agreements with our executive officers, each of them may terminate their employment with us at any time. We do not maintain “key person” insurance for any of our executives or other employees.

Recruiting and retaining qualified scientific, clinical, manufacturing, sales and market access personnel will also be critical to our success. The loss of the services of our executive officers 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 executive officers and key employees, and recruiting additional 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 products. Competition to hire from this limited 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 discovery and preclinical development and commercialization strategy. Our consultants and advisors may be employed by employers other than us and 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.

We have expanded, or expect to expand, our development, regulatory, operations, medical affairs, market access, marketing and sales capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.

We have experienced, and expect to continue to experience, significant growth in the number of our employees and the scope of our operations, particularly in the areas of development, regulatory affairs, operations, medical affairs, sales, marketing and market access. To manage our current and 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 resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. 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.

Third-party expectations relating to environmental, social and governance factors may impose additional costs and expose us to new risks.

In recent years, there has been an increased focus from certain investors, employees and other stakeholders concerning corporate responsibility, specifically related to environmental, social and governance, or ESG, factors. Third-party providers of ESG ratings and reports on companies have increased in number, resulting in varied and, in some cases, inconsistent standards. Topics taken into account in such assessments include, among others, the company’s efforts and impacts with respect to climate change and human rights, ethics and compliance with the law, and the role of the company’s board of directors in supervising various sustainability issues. In addition to the topics typically considered in such reviews, in our industry, the public’s ability to access our medicines is of particular importance.

Some investors may use third-party ESG ratings and reports to guide their investment strategies and, in some cases, may choose not to invest in us if they believe our ESG practices are inadequate. The criteria by which companies’ ESG practices are assessed are evolving, which could result in greater expectations of us and cause us to undertake costly initiatives to satisfy such new criteria. Alternatively, if we elect not to or are unable to satisfy new criteria or do not meet the criteria of a specific third-party provider, some investors may conclude that our policies with respect to ESG are inadequate and choose not to invest in us.

If our ESG practices do not meet evolving investor or other stakeholder expectations and standards, then our reputation, our ability to attract or retain employees and our desirability as an investment or business partner could be negatively impacted. Similarly, our failure or perceived failure to adequately pursue or fulfill any goals and objectives or to satisfy various reporting standards within the timelines we announce, or at all, could expose us to additional regulatory, social or other scrutiny of us, the imposition of unexpected costs, or damage to our reputation, which in turn could have a material adverse effect on our business, financial condition, cash flows and results of operations and could cause the market value of our common stock to decline.

Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.

Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. From time to time, including as a result of global pandemics, bank failures, actual or perceived changes in interest rates, potential tariffs and economic inflation, global financial markets have experienced volatility and uncertainty. A severe or prolonged economic downturn could result in a variety of risks to our business, including our ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy could also strain our suppliers, possibly resulting in supply disruption. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.

If our information technology systems, or those of third parties with whom we work, or our data are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.

In the ordinary course of our business, we and the third parties with whom we work process sensitive data, and, as a result, we and the third parties with whom we work face a variety of evolving threats that could cause security incidents.

Cyberattacks, malicious internet-based activity, online and offline fraud, and other similar activities threaten the confidentiality, integrity, and availability of our sensitive data 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 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 and 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 and develop our products or services.

We and the third parties with whom we work are subject to a variety of evolving threats, including but not limited to social-engineering attacks (including through deep fakes, which may be increasingly more difficult to identify as fake, and phishing attacks), malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks, credential stuffing, credential harvesting, personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, attacks enhanced or facilitated by artificial intelligence, or AI, telecommunications failures, earthquakes, fires, floods, and other similar threats.

In particular, severe ransomware attacks are becoming increasingly prevalent and can lead to significant interruptions in our operations, ability to produce and develop our products or services, loss of sensitive 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.

In addition, our reliance on third parties could introduce new cybersecurity risks and vulnerabilities, including supply-chain attacks, and other threats to our business operations. We rely on third parties and technologies to operate critical business systems to process sensitive data in a variety of contexts, including, without limitation, information technology systems, cloud-based infrastructure, applications, websites, data center facilities, encryption and authentication technology, employee email, content delivery to customers, and other functions. We also rely on third parties to provide other products, services, parts, or otherwise to operate our business. Our business, including our ability to manufacture drug products and conduct clinical trials, therefore depends on the continuous, effective, reliable and secure operation of our information technology resources. Our ability to monitor these third parties’ information security practices is limited, and these third parties may not have adequate information security measures in place. If the third parties with whom we work experience a security incident or other interruption, as they have in the past and may in the future, we could experience adverse consequences. While we may be entitled to damages if these third parties fail to satisfy their privacy or security-related obligations to us, any award may be insufficient to cover our damages, or we may be unable to recover such award. Similarly, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties’ infrastructure in our supply chain or that of the third parties with whom we work have not been compromised.

Remote work has increased risks to our information technology systems and data, as our employees utilize network connections, computers, and devices outside our premises or network, including working at home, while in transit and in public locations. Additionally, future or past business transactions (such as acquisitions or integrations) could 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.

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 may not, however, detect and remediate all such vulnerabilities including on a timely basis. Further, we may 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 could cause a security incident or other interruption that could result in unauthorized, unlawful, or accidental acquisition, modification, destruction, loss, alteration, encryption, disclosure of, or access to our sensitive data 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 provide our products.

We have in the past and may in the future expend significant resources or modify our business activities (including our clinical trial activities) to try to protect against security incidents. Additionally, certain data privacy and security obligations require us to implement and maintain specific security measures designed to protect our information technology systems and sensitive data. Applicable data privacy and security obligations may require us to notify relevant stakeholders, including affected individuals, customers, regulators, and investors, of security incidents, or to implement other requirements, such as providing credit monitoring. Such disclosures and compliance with such requirements are costly, and the disclosure or the failure to comply with such requirements could lead to adverse consequences.

We (or third parties with whom we work) have in the past experienced, and may in the future experience or be perceived to have experienced, a security incident. For example, in July 2024, we were notified of a cybersecurity incident experienced by a former clinical trial service provider. The incident was investigated by our Incident Review Team and evaluated by our Materiality Assessment Team, which concluded that the incident was not material to our business. Adverse consequences of a security incident may include government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing sensitive data (including personal data); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; diversion of management attention, interruptions in our operations (including availability of data); financial loss; and other similar harms. Security incidents and attendant consequences may prevent patients from participating, or cause patients to cease participation, in our clinical trials, and negatively impact our ability to grow and operate our business.

Additionally, 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. Furthermore, we cannot be sure that our insurance coverage will be adequate or sufficient to protect us from or to mitigate liabilities arising out of our privacy and security practices, that such coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay future claims.

In addition to experiencing a security incident, third parties may gather, collect, or infer sensitive data about us from public sources, data brokers, or other means that reveals competitively sensitive details about our organization and could be used to undermine our competitive advantage or market position. Additionally, sensitive data of the Company 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.

Our business and operations would suffer in the event of system failures.

Despite the implementation of security measures, our internal computer systems and those of our CROs, collaborators and third parties on whom we rely are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. We are increasingly dependent upon our technology systems to operate our business and our ability to effectively manage our business depends on the security, reliability and adequacy of our technology systems and data, which includes use of cloud technologies.

Interruptions in our operations due to system failures, accidents, security breaches or other events could result in a material disruption of our drug development programs. For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and we may incur substantial costs to attempt to recover or reproduce the data. If any disruption or security breach resulted in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and/or the further development of our product candidates could be delayed.

Actual or threatened public health epidemics or outbreaks may adversely impact our industry, including our clinical trials, our supply chain, our liquidity and access to capital markets and our business development activities.

The extent to which future pandemics may impact our clinical trials, our supply chain, our access to capital and our business development activities, will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the timing and duration of future pandemics, the transmissibility and severity of illness caused by future pandemics, the efforts by governments and businesses to contain the spread of future pandemics, business closures or business disruptions and the impact on the economy and capital markets.

Our operations are vulnerable to interruption by natural disasters, power loss, terrorist activity and other events beyond our control, the occurrence of which could materially harm our business.

Businesses located in California have, in the past, been subject to electrical blackouts as a result of a shortage of available electrical power, and any future blackouts could disrupt our operations. We are vulnerable to a major earthquake, wildfire and other natural disasters. We do not carry any business interruption insurance that would compensate us for actual losses from interruption of our business that may occur, and any losses or damages incurred by us could cause our business to materially suffer.

Risks Related to Ownership of our Common Stock

Our stock price may fluctuate significantly and you may have difficulty selling your shares based on current trading volumes of our stock.

Our common stock has been listed on the Nasdaq Global Select Market, or Nasdaq, under the symbol “KURA” since November 5, 2015. The high and low price per share of our common stock as reported by Nasdaq during the period from November 5, 2015 through December 31, 2024, were $43.00 and $2.50, respectively. We cannot predict the extent to which investor interest in our company will sustain an active trading market on Nasdaq or any other exchange in the future. We have several stockholders, including affiliated stockholders, who hold substantial blocks of our stock. Sales of large numbers of shares by any of our large stockholders could adversely affect our trading price, particularly given our small historic trading volumes. If stockholders holding shares of our common stock sell, indicate an intention to sell, or if it is perceived that they will sell, substantial amounts of their common stock in the public market, the trading price of our common stock could decline. Moreover, if an active trading market is not sustained or if the volume of trading is limited, holders of our common stock may have difficulty selling their shares.

The price of our common stock may be volatile and may be influenced by numerous factors, some of which are beyond our control.

The market for our common stock could fluctuate substantially due to a variety of factors, some of which may be beyond our control. In addition to the factors discussed in this “Risk Factors” section and elsewhere in this Annual Report, these factors include:

  • the product candidates we seek to pursue, and our ability to obtain rights to develop, commercialize and market those product candidates;

  • our decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial;

  • actual or anticipated adverse results or delays in our clinical trials;

  • our failure to commercialize our product candidates, if approved;

  • changes in the structure of healthcare payment systems;

  • unanticipated serious safety concerns related to the use of any of our product candidates;

  • adverse regulatory decisions;

  • additions or departures of key scientific or management personnel;

  • changes in laws or regulations applicable to our product candidates, including without limitation clinical trial requirements for approvals;

  • disputes or other developments relating to patents and other proprietary rights and our ability to obtain patent protection for our product candidates;

  • our dependence on third parties, including CROs as well as our potential partners that produce companion diagnostic products;

  • failure to meet or exceed any financial guidance or expectations regarding development milestones that we may provide to the public;

  • actual or anticipated variations in quarterly operating results, liquidity or other indicators of our financial condition;

  • failure to meet or exceed the estimates and projections of the investment community;

  • overall performance of the equity markets and other factors that may be unrelated to our operating performance or the operating performance of our competitors, including changes in market valuations of similar companies;

  • market conditions or trends in the biotechnology and biopharmaceutical industries;

  • introduction of new products offered by us or our competitors;

  • announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;

  • our ability to maintain an adequate rate of growth and manage such growth;

  • issuances of debt or equity securities;

  • sales of our common stock by us or our stockholders in the future, or the perception that such sales could occur;

  • trading volume of our common stock;

  • ineffectiveness of our internal control over financial reporting or disclosure controls and procedures;

  • general political and economic conditions;

  • effects of natural or man-made catastrophic events; and

  • other events or factors, many of which are beyond our control.

In addition, the stock market in general, and the stocks of small-cap biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies, including as a result of global pandemics, bank failures, actual or perceived changes in interest rates, potential tariffs and economic inflation. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance. These events may also lead to securities litigation, which can be expensive and time-consuming to defend, regardless of the merit or outcome. The realization of any of the above risks or any of a broad range of other risks, including those described in these “Risk Factors,” could have a dramatic and material adverse impact on the market price of our common stock.

We have broad discretion in the use of our cash and may not use our cash effectively, which could adversely affect our results of operations.

Our management has broad discretion in the application of our cash resources. Because of the number and variability of factors that will determine our use of our cash resources, our management might not apply our cash in ways that ultimately increase the value of our common stock. The failure by our management to apply our cash effectively could harm our business. Pending their use, we may invest our cash in short-term, investment-grade, interest-bearing securities. These investments may not yield a favorable return to our stockholders. If we do not invest or apply our cash in ways that enhance stockholder value, we may fail to achieve expected financial results, which could cause our stock price to decline.

FINRA sales practice requirements may limit a stockholder’s ability to buy and sell our stock.

The Financial Industry Regulatory Authority, or FINRA, has adopted rules requiring that, in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer. Prior to recommending speculative or low-priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information. Under interpretations of these rules, FINRA has indicated its belief that there is a high probability that speculative or low-priced securities will not be suitable for at least some customers. If these FINRA requirements are applicable to us or our securities, they may make it more difficult for broker-dealers to recommend that at least some of their customers buy our common stock, which may limit the ability of our stockholders to buy and sell our common stock and could have an adverse effect on the market for and price of our common stock.

The resale of shares covered by our effective shelf registration statements could adversely affect the market price of our common stock in the public market, which result would in turn negatively affect our ability to raise additional equity capital.

The sale, or availability for sale, of our common stock in the public market may adversely affect the prevailing market price of our common stock and may impair our ability to raise additional capital by selling equity or equity-linked securities. We have filed shelf registration statements with the SEC, which have been declared effective, to register the resale of certain shares of our common stock. The shelf registration statements permit the resale of such shares at any time, subject to restrictions under applicable law. The resale of a significant number of shares of our common stock in the public market could adversely affect the market price for our common stock and make it more difficult for you to sell shares of our common stock at times and prices that you feel are appropriate. Furthermore, we expect that, because there are a large number of shares registered pursuant to the shelf registration statements, the selling stockholders named in such registration statements will continue to offer shares covered by such shelf registration statements for a significant period of time, the precise duration of which cannot be predicted. Accordingly, the adverse market and price pressures resulting from an offering pursuant to the shelf registration statements may continue for an extended period of time and continued negative pressure on the market price of our common stock could have a material adverse effect on our ability to raise additional equity capital.

We will incur increased costs and demands upon management as a result of complying with the laws and regulations affecting public companies, which could harm our operating results.

As a public company, we have incurred and will incur significant legal, accounting and other expenses, including costs associated with public company reporting requirements. We also have incurred and will incur costs associated with current corporate governance requirements, including requirements under Section 404 and other provisions of the Sarbanes-Oxley Act of 2002, or Sarbanes-Oxley Act, as well as rules implemented by the SEC or Nasdaq or any other stock exchange or inter-dealer quotations system on which our common stock may be listed in the future. The expenses incurred by public companies for reporting and corporate governance purposes have increased dramatically in recent years.

If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, our ability to operate our business and investors’ views of us.

We are required to comply with certain aspects of Section 404 of the Sarbanes-Oxley Act. Section 404 of the Sarbanes-Oxley Act requires public companies to, among other things, conduct an annual review and evaluation of their internal controls over financial reporting. Ensuring that we have adequate internal financial and accounting controls and procedures in place so that we can produce accurate financial statements on a timely basis is a costly and time-consuming effort that requires frequent evaluation. Our failure to maintain the effectiveness of our internal controls in accordance with the requirements of the Sarbanes-Oxley Act could have a material adverse effect on our business. We could lose investor confidence in the accuracy and completeness of our financial reports, which could have an adverse effect on the price of our common stock. In addition, if our efforts to comply with new or changed laws, regulations and standards differ from the activities intended by regulatory or governing bodies, regulatory authorities may initiate legal proceedings against us and our business may be harmed.

Future sales and issuances of our common stock or rights to purchase or acquire common stock, including pursuant to our equity incentive plans, outstanding stock options, restricted stock units, performance-based restricted stock units, warrants, pre-funded warrants or otherwise, could result in dilution to the percentage ownership of our stockholders and could cause our stock price to fall.

We expect that significant additional capital will be needed in the future to continue our planned operations. To raise capital, we may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time.

If we sell common stock, convertible securities or other equity securities in more than one transaction, investors in a prior transaction may be materially diluted by subsequent sales. Additionally, any such sales may result in material dilution to our existing stockholders, and new investors could gain rights, preferences and privileges senior to those of holders of our common stock. Further, any future sales of our common stock by us or resales of our common stock by our existing stockholders or the perception that such sales could occur could cause the market price of our common stock to decline. In November 2023, we entered into the ATM Facility under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million. We have not sold any shares of our common stock under the ATM Facility.

Pursuant to our Amended and Restated 2014 Equity Incentive Plan, or 2014 Plan, we are authorized to grant equity awards consisting of shares of our common stock to our employees, directors and consultants. As of December 31, 2024, we had 5,725,119 shares of common stock available for grant under the 2014 Plan, options to purchase up to an aggregate of 12,351,651 shares of common stock outstanding, 1,126,404 unvested restricted stock units outstanding and 1,313,100 unvested performance-based restricted stock units outstanding. Also, pursuant to our 2023 Inducement Option Plan, as amended, or Inducement Plan, we are authorized to grant nonstatutory stock options to individuals that were not previously our employees or directors (or following a bona fide period of non-employment), as an inducement material to the individuals’ entry into employment with us, pursuant to Nasdaq Listing Rule 5635(c)(4). As of December 31, 2024, we had 1,948,600 shares of common stock available for grant under the Inducement Plan and options to purchase up to an aggregate of 551,400 shares of common stock outstanding.

In addition, we may grant or provide for the grant of rights to purchase shares of our common stock pursuant to our 2015 Employee Stock Purchase Plan, or ESPP. As of December 31, 2024, we had 558,608 shares of common stock reserved for future issuance under the ESPP.

Further, as of December 31, 2024, (i) warrants to purchase up to (a) 33,988 shares of our common stock at an exercise price of $3.31 per share and (b) 26,078 shares of our common stock at an exercise price of $14.38 per share and (ii) pre-funded warrants to purchase up to 8,933,375 shares of our common stock at an exercise price of $0.0001 per share were outstanding.

Any future grants of options, restricted stock units, performance-based restricted stock units, warrants, pre-funded warrants or other securities exercisable or convertible into our common stock, or the exercise or conversion of such shares, and any sales of such shares in the market, could have an adverse effect on the market price of our common stock.

Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management.

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

  • a prohibition on stockholder action through written consent, which requires that all stockholder actions be taken at a meeting of our stockholders;
  • a requirement that special meetings of stockholders be called only by the chairman of the board of directors, the chief executive officer, or by a majority of the total number of authorized directors;
  • advance notice requirements for stockholder proposals and nominations for election to our board of directors;
  • division of our board of directors into three classes;
  • a requirement 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 662⁄3% of all outstanding shares of our voting stock then entitled to vote in the election of directors;
  • a requirement of approval of not less than 662⁄3% of all outstanding shares of our voting stock to amend any bylaws by stockholder action or to amend specific provisions of our certificate of incorporation;
  • the authority of the board of directors to issue preferred stock on terms determined by the board of directors without stockholder approval and which preferred stock may include rights superior to the rights of the holders of common stock; and
  • a requirement that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any of our directors or officers to us or our stockholders, (iii) any action asserting a claim against us arising pursuant to any provision of the Delaware General Corporation Law or our certificate of incorporation or bylaws, or (iv) any action asserting a claim against us governed by the internal affairs doctrine. These provisions would not apply to suits brought to enforce a duty or liability created by the Exchange Act. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal courts have jurisdiction to entertain such claims.

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

Our charter documents provide that the Court of Chancery of the State of Delaware 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, as amended, and amended and restated bylaws provide that the Court of Chancery of the State of Delaware is the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law:

  • any derivative action or proceeding brought on our behalf;
  • any action asserting a claim of breach of a fiduciary duty owed by any of our directors or officers to us or our stockholders;
  • any action asserting a claim against us arising pursuant to any provision of the Delaware General Corporation Law or our certificate of incorporation or bylaws; and
  • any action asserting a claim against us governed by the internal affairs doctrine.

These provisions would not apply to suits brought to enforce a duty or liability created by the Exchange Act. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal courts have jurisdiction to entertain such claims.

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 a court were to find the exclusive-forum provisions in our amended and restated certificate of incorporation, as amended, and amended and restated bylaws to be inapplicable or unenforceable in an action, we may incur further significant additional costs associated with resolving the dispute in other jurisdictions, all of which could seriously harm our business.

Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.

New income, sales, use or other tax laws, statutes, rules, regulations or ordinances could be enacted at any time, which could affect the tax treatment of our domestic and foreign earnings. Any new taxes could adversely affect our domestic and international business operations, and our business and financial performance. Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or applied adversely to us. For example, legislation enacted in 2017 informally titled the Tax Cuts and Jobs Act, the Coronavirus Aid, Relief, and Economic Security Act and the IRA enacted many significant changes to the U.S. tax laws. Future guidance from the Internal Revenue Service and other tax authorities with respect to such legislation may affect us, and certain aspects of such legislation could be repealed or modified in future legislation. In addition, it is uncertain if and to what extent various states will conform to federal tax laws. Future tax reform legislation could have a material impact on the value of our deferred tax assets, could result in significant one-time charges, and could increase our future U.S. tax expense.

Effective January 1, 2022, the Tax Cuts and Jobs Act eliminated the option to deduct research and development expenses for tax purposes in the year incurred and requires taxpayers to capitalize and subsequently amortize such expenses over five years for research activities conducted in the United States and over 15 years for research activities conducted outside the United States. Unless the U.S. Department of the Treasury issues regulations that narrow the application of this provision to a smaller subset of our research and development expenses or the provision is deferred, modified, or repealed by Congress, we expect an increase in our net deferred tax assets and an offsetting similarly sized increase in our valuation allowance over these amortization periods. The actual impact of this provision will depend on multiple factors, including the amount of research and development expenses we will incur and whether we conduct our research and development activities inside or outside the United States.

Our ability to use net operating loss carryforwards and certain other tax attributes to offset future taxable income or taxes may be limited.

Under current law, federal net operating losses incurred in tax years beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility of such federal net operating loss carryforwards in a year is limited to 80% of taxable income in such year. In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change in its equity ownership value over a three-year period, the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-change income or taxes may be limited. We have experienced an ownership change in the past and we may also experience additional ownership changes in the future as a result of subsequent shifts in our stock ownership, some of which may be outside of our control. If an ownership change occurs and our ability to use our net operating loss carryforwards is materially limited, it would harm our future operating results by effectively increasing our future tax obligations. In addition, at the state level, there may be periods during which the use of net operating loss carryforwards is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. For example, on June 27, 2024, California Senate Bill 167, or SB 167, was enacted into law. SB 167 provides for a three-year suspension of net operating losses under the California Personal Income Tax and Corporation Tax and a three-year cap on the use of business incentive tax credits to offset no more than $5 million of tax per year. As a result, if we earn net taxable income, we may be unable to use all or a material portion of our state net operating loss carryforwards and other tax attributes, which could potentially result in increased future tax liability to us and adversely affect our future cash flows.

We do not intend to pay cash dividends on our capital stock in the foreseeable future.

We have never declared or paid any dividends on our common stock and do not anticipate paying any dividends in the foreseeable future. Any payment of cash dividends in the future would depend on our financial condition, contractual restrictions, including under our term loan facility, solvency tests imposed by applicable corporate laws, results of operations, anticipated cash requirements and other factors and will be at the discretion of our board of directors. Our stockholders should not expect that we will ever pay cash or other dividends on our outstanding capital stock.

General Risk Factors

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

The trading market for our common stock depends in part on the research and reports that securities or industry analysts publish about us or our business. If one or more of the analysts who cover us downgrade our common stock or publish inaccurate or unfavorable research about our business, our common stock price would likely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, demand for our common stock could decrease, which might cause our common stock price and trading volume to decline.

Our business could be negatively affected as a result of actions of activist stockholders, and such activism could impact the trading value of our securities.

Stockholders may, from time to time, engage in proxy solicitations or advance stockholder proposals, or otherwise attempt to effect changes and assert influence on our board of directors and management. Activist campaigns that contest or conflict with our strategic direction or seek changes in the composition of our board of directors could have an adverse effect on our operating results and financial condition. A proxy contest would require us to incur significant legal and advisory fees, proxy solicitation expenses and administrative and associated costs and require significant time and attention by our board of directors and management, diverting their attention from the pursuit of our business strategy. Any perceived uncertainties as to our future direction and control, our ability to execute on our strategy, or changes to the composition of our board of directors or senior management team arising from a proxy contest could lead to the perception of a change in the direction of our business or instability which may result in the loss of potential business opportunities, make it more difficult to pursue our strategic initiatives, or limit our ability to attract and retain qualified personnel and business partners, any of which could adversely affect our business and operating results. If individuals are ultimately elected to our board of directors with a specific agenda, it may adversely affect our ability to effectively implement our business strategy and create additional value for our stockholders. We may choose to initiate, or may become subject to, litigation as a result of the proxy contest or matters arising from the proxy contest, which would serve as a further distraction to our board of directors and management and would require us to incur significant additional costs. In addition, actions such as those described above could cause significant fluctuations in our stock price based upon temporary or speculative market perceptions or other factors that do not necessarily reflect the underlying fundamentals and prospects of our business.

Securities class action litigation could divert our management’s attention and harm our business and could subject us to significant liabilities.

The stock markets have from time to time experienced significant price and volume fluctuations that have affected the market prices for the equity securities of life sciences and biotechnology companies. These broad market fluctuations may cause the market price of our common stock to decline. In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because biotechnology and biopharma companies have experienced significant stock price volatility in recent years. Even if we are successful in defending claims that may be brought in the future, such litigation could result in substantial costs and may be a distraction to our management and may lead to an unfavorable outcome that could adversely impact our financial condition and prospects.

Our employees, independent contractors, principal investigators, consultants, vendors, distributors and CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk that our employees, independent contractors, principal investigators, consultants, vendors, distributors and CROs may engage in fraudulent or other illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent conduct or unauthorized activities that violate FDA regulations, including those laws that require the reporting of true, complete and accurate information to the FDA, manufacturing standards, federal and state healthcare fraud and abuse laws and regulations, and laws that require the true, complete and accurate reporting of financial information or data. 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. Misconduct by our employees and other third parties may also include the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. We have adopted a Code of Business Conduct and Ethics, but it is not always possible to identify and deter misconduct by our 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 be in compliance with such laws or regulations. 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 significant civil and criminal penalties, damages, fines, the curtailment or restructuring of our operations, the exclusion from participation in federal and state healthcare programs and imprisonment.

We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.

We are subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, and various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls, and anti-corruption and anti-money laundering laws and regulations, including the Foreign Corrupt Practices Act, or FCPA, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, and other state and national anti-bribery and anti-money laundering laws in the countries in which we conduct activities. Export controls and trade sanctions laws and regulations may restrict or prohibit altogether the provision, sale, or supply of our products to certain governments, persons, entities, countries, and territories, including those that are the target of comprehensive sanctions or an embargo. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, clinical research organizations, contractors and other collaborators and partners from authorizing, promising, offering, providing, soliciting or receiving, directly or indirectly, improper payments or anything else of value to recipients in the public or private sector. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. We may engage third parties for clinical trials outside of the United States to sell our products internationally once we enter a commercialization phase, and/or to obtain necessary permits, licenses, patent registrations and other regulatory approvals. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities and other organizations. We can be held liable for the corrupt or other illegal activities of our employees, agents, clinical research organizations, contractors and other collaborators and partners, even if we do not explicitly authorize or have actual knowledge of such activities. Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.

Item 1B. Unresolved Staff Comments.

None.

Item 1C. Cybersecurity.

Risk Management and Strategy

We have implemented and maintain various information security processes designed to identify, assess and manage material risks from cybersecurity threats to our critical computer networks, third party hosted services, communications systems, hardware and software, and our critical data, including intellectual property, confidential information that is proprietary, strategic, financial, or competitive in nature, information related to our clinical trials and preclinical studies and information of our employees, or Information Systems and Data. Our Information Technology, or IT, department identifies and assesses risks from cybersecurity threats by monitoring and evaluating our threat environment using various methods including, for example, manual and automated tools, subscribing to and analyzing reports and services that identify cybersecurity threats and threat actors, evaluating threats that are reported to us, using external intelligence feeds, engaging in internal and external audits, and engaging third parties to conduct threat assessments. Depending on the environment, we implement and maintain various technical, physical, and organizational measures, processes, standards and policies designed to manage and mitigate material risks from cybersecurity threats to our Information Systems and Data, including, for example, a disaster recover/business continuity plan and information security policy, encrypting certain data, data segmentation, network security controls, access and physical security controls, asset management, tracking and disposal, systems monitoring, employee training, maintaining cyber insurance and using third party threat detection software. The head of our IT department, who has more than 25 years of experience in IT and more than 15 years of experience in cybersecurity for public companies, reports to our Chief Operating Officer and works with management to prioritize our risk management processes and mitigate cybersecurity threats that are more likely to lead to a material impact to our business. We have established an Incident Review Team, which consists of representatives of our Finance, IT and Legal departments, to investigate, evaluate and respond to cybersecurity incidents. The Incident Review Team is responsible for escalating confirmed cybersecurity incidents to a Materiality Assessment Team, consisting of members of management. The Materiality Assessment Team is responsible for reporting cybersecurity incidents to the audit committee of the board of directors, as appropriate based upon the nature of the incident (or series of incidents). We use third-party service providers to assist us from time to time to identify, assess, and manage material risks from cybersecurity threats, including for example threat intelligence service providers, cybersecurity software, and darkweb monitoring services. We also use third-party service providers to perform a variety of functions throughout our business, such as application providers, hosting companies, CROs and contract manufacturing organizations. Depending on the nature of the services provided, the sensitivity of the Information Systems and Data at issue, the access to be provided to such Information Systems and Data, and the identity of the provider, our vendor due diligence involves different levels of assessment of systems and controls designed to help identify cybersecurity risks associated with a provider. In addition, we may impose contractual obligations related to cybersecurity on the provider.

For a description of the risks from cybersecurity threats that may materially affect us 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 “If our information technology systems, or those of third parties with whom we work, or our data are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.”

Governance

Our cybersecurity risk assessment and management processes are implemented and maintained by certain company management, including the head of our IT department. The head of IT is responsible for integrating cybersecurity risk considerations into our overall risk management strategy, helping prepare for cybersecurity incidents, approving cybersecurity processes, and reviewing security assessments and other security-related reports.

Our cybersecurity incident response policy is designed to escalate certain cybersecurity incidents to our Materiality Assessment Team, comprised of members of management. In addition, our cybersecurity incident response policy includes reporting to the audit committee of the board of directors for certain cybersecurity incidents.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. The audit committee receives regular reports from the head of our IT department concerning the measures we have taken to monitor and evaluate our cybersecurity threat environment and any cybersecurity incidents that have occurred.

Item 2. Properties.

We occupy 13,420 square feet of office space for our corporate headquarters in San Diego, California under a lease that expires in November 2025. We also occupy approximately 16,541 square feet of office space in Boston, Massachusetts under a lease that expires in July 2031, and approximately 5,315 square feet of office and lab space in San Diego, California under a lease that expires in August 2025. On January 13, 2025, we entered into a lease agreement for approximately 32,512 square feet of office space for our future corporate headquarters and lab space in San Diego, California. The commencement date of the lease is expected to be the earlier to occur of (i) the date upon which we first commence to conduct business in the space and (ii) October 1, 2025.

Item 3. Legal Proceedings.

We are not currently a party to, nor is our property the subject of, any material legal proceedings.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

Market Information

Our common stock is listed on the Nasdaq Global Select Market under the symbol “KURA.”

Holders of Record

As of February 20, 2025, there were approximately 97 holders of record of our common stock, which does not include beneficial owners of our common stock whose shares are held in the name of various dealers, clearing agencies, banks, brokers, and other fiduciaries.

Dividend Policy

We have never paid cash dividends on any of our capital stock and we currently intend to retain our future earnings, if any, to fund the development and growth of our business. We do not intend to pay cash dividends to holders of our common stock in the foreseeable future. In addition, our ability to pay cash dividends is currently prohibited by the terms of our term loan facility, subject to customary exceptions. Any future determination related to our dividend policy will be made at the discretion of our board of directors and will depend on our financial condition, results of operations, capital requirements and other factors our board of directors deems relevant.

Securities Authorized for Issuance Under Equity Compensation Plans

Information about securities authorized for issuance under our equity compensation plans is incorporated herein by reference to Item 12 of Part III of this Annual Report.

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

None.

Recent Sales of Unregistered Securities

Except as previously reported in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with the Securities and Exchange Commission, or the SEC, during the year ended December 31, 2024, there were no unregistered sales of equity securities by us during the year ended December 31, 2024.

Stock Performance Graph and Cumulative Total Return

The graph below shows the cumulative total stockholder return assuming the investment of $100 on December 31, 2019 (and the reinvestment of dividends thereafter), in each of (i) Kura Oncology, Inc.’s common stock, (ii) the Nasdaq Biotechnology Index and (iii) the Nasdaq Composite Index. The comparisons in the graph below are based upon historical data and are not indicative of, or intended to forecast, future performance of our common stock or Indexes.

The foregoing graph is furnished solely with this Annual Report, and is not filed with this Annual Report, and shall not be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, or the Exchange Act, whether made by us before or after the date hereof, regardless of any general incorporation language in any such filing, except to the extent we specifically incorporate this material by reference into any such filing.

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Item 6. [Reserved].

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion of the financial condition and results of operations of Kura Oncology, Inc. should be read in conjunction with the financial statements and the notes to those statements appearing in this Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks, assumptions and uncertainties. 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 include, but are not limited to, those set forth in “Item 1A. Risk Factors” in this Annual Report. All forward-looking statements included in this Annual Report are based on information available to us as of the time we file this Annual Report and, except as required by law, we undertake no obligation to update publicly or revise any forward-looking statements. For the comparison of the financial results for the fiscal years ended December 31, 2023 and 2022, see Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 27, 2024.

References to “Kura Oncology, Inc.,” “we,” “us” and “our” refer to Kura Oncology, Inc.

Overview

We are a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Our pipeline consists of small molecule product candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes and, in general, we intend to pair our product candidates with molecular or cellular diagnostics to identify those patients most likely to respond to treatment.

Our lead product candidate is ziftomenib, a selective investigational inhibitor of the menin-KMT2A protein-protein interaction. We are developing ziftomenib for the treatment of genetically defined subsets of acute leukemias, including AML and ALL. In November 2024, we entered into a collaboration and license agreement with Kyowa Kirin to develop and commercialize ziftomenib for the treatment of patients with AML and other hematologic malignancies, which may be expanded into other indications at the option of Kyowa Kirin, subject to certain conditions. We also are exploring the use of ziftomenib for the treatment of GIST and ziftomenib and our next-generation menin inhibitors for use in other indications, including type 2 diabetes and certain solid tumors.

Our second product candidate is KO-2806, a selective investigational FTI, which we are evaluating as a monotherapy and as a companion inhibitor to certain targeted therapies in large solid tumor indications, including RCC and NSCLC.

Our third product candidate, tipifarnib, is a selective investigational FTI, which we are evaluating in combination with alpelisib, a PI3 kinase alpha inhibitor, in patients with HNSCC whose tumors have HRAS overexpression and/or PIK3CA mutation and/or amplification.

We also have additional programs that are at a discovery stage. We plan to advance our product candidates through a combination of internal development and strategic partnerships while maintaining significant development and commercial rights.

Liquidity Overview

As of December 31, 2024, we had cash, cash equivalents and short-term investments of $727.4 million.

On November 20, 2024, we entered into the Kyowa Agreement to develop and globally commercialize ziftomenib for the treatment of patients with AML and other hematologic malignancies, which may be expanded into other indications at the option of Kyowa Kirin, subject to certain conditions. In exchange for the licenses and rights granted to Kyowa Kirin to participate in the development and commercialization of ziftomenib, we received an upfront payment of $330.0 million.

In January 2024, we completed a private placement in which we sold to certain institutional accredited investors an aggregate of 1,376,813 shares of our common stock at a purchase price of $17.25 per share and pre-funded warrants to purchase up to an aggregate of 7,318,886 shares of common stock at a purchase price of $17.2499 per pre-funded warrant (representing the $17.25 per share purchase price less the exercise price of $0.0001 per warrant share), or the Private Placement. Net proceeds from the Private Placement, after deducting expenses, were approximately $145.8 million. As of December 31, 2024, pre-funded warrants to purchase 559,424 of such shares of common stock had been exercised and 6,759,462 remained outstanding.

In November 2023, we entered into a Sales Agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., or the ATM Facility, under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million. We have not sold any shares of our common stock under the ATM Facility.

In June 2023, we completed a public offering in which we sold an aggregate of 5,660,871 shares of common stock at a price of $11.50 per share as well as pre-funded warrants to purchase 3,034,782 shares of our common stock at a price of $11.4999 per pre-funded warrant (representing the $11.50 per share purchase price less the exercise price of $0.0001 per warrant share). Net proceeds from the public offering, after deducting underwriting discounts and commissions and offering expenses, were approximately $93.6 million. As of December 31, 2024, pre-funded warrants to purchase 860,869 of such shares of common stock had been exercised and 2,173,913 remained outstanding. On January 16, 2025, the remaining 2,173,913 pre-funded warrants were exercised.

In November 2022, we entered into a loan and security agreement, or the Loan Agreement, with several banks and other financial institutions or entities party thereto, or collectively the Lenders, and Hercules Capital, Inc., or Hercules, in its capacity as administrative agent and collateral agent for itself and the Lenders, providing for up to $125.0 million in a series of term loans, or Term Loans. Upon entering into the Loan Agreement, we borrowed $10.0 million of an initial $25.0 million tranche of Term Loans, or the Tranche 1 Loan. In September 2023, the draw period for the remaining $15.0 million of the Tranche 1 Loan expired without us drawing down such additional loan. In March 2024, the draw period for the $35.0 million second tranche of Term Loans expired without us drawing down such additional loan. In December 2024, the draw period for the (i) $40.0 million third tranche of Term Loans and (ii) $25.0 million fourth tranche of Term Loans each expired without us drawing down such additional loans. No further Term Loans may be drawn under the Loan Agreement.

To date, we have not generated any revenues from product sales, and we do not have any approved products. Since our inception, we have funded our operations primarily through equity and debt financings and revenues under the Kyowa Agreement. We anticipate that we will require significant additional financing in the future to continue to fund our operations as discussed more fully below under the heading “Liquidity and Capital Resources.”

Financial Operations Overview

Revenue from Collaborations and Licenses

We generate revenue primarily through collaboration and license agreements. Such agreements may require us to deliver various rights and/or services, including intellectual property rights or licenses and research, development and other services. Under such agreements, we are generally eligible to receive non-refundable upfront payments, funding for research, development and other services, milestone payments, and royalties.

Our collaboration agreements fall under the scope of Accounting Standards Codification, or ASC, Topic 808, Collaborative Arrangements, or Topic 808, when there is a joint operating activity and when both parties are active participants in the arrangement and are exposed to significant risks and rewards. For our arrangements under the scope of Topic 808, we evaluate each promised good or service that is distinct in accordance with ASC Topic 606, Revenue from Contracts with Customers, or Topic 606. (i.e., a unit of account) and apply Topic 606 to those units of account that are determined to be with a customer. For all other units of account that are not within the scope of other relevant accounting topics, we analogize to other authoritative accounting literature, such as Topic 606.

Topic 606 requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers under a five-step model: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when or as a performance obligation is satisfied.

In contracts where we have more than one promise to provide the customer with goods or services, each promise is evaluated to determine whether it is a distinct performance obligation based on whether (i) the customer can benefit from the good or service on its own or together with other resources that are readily available and (ii) the good or service is separately identifiable from other promises in the contract. The evaluation of whether a promised good or service is a distinct performance obligation may require significant judgment and is based on the facts and circumstances surrounding each contract and the nature of the promised goods and services within each contract.

We are required to make estimates of the transaction price, including variable consideration that is subject to a constraint. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur and when the uncertainty associated with the variable consideration is subsequently resolved. At the inception of arrangements that include variable consideration, we may be required to exercise significant judgment to estimate the amount of variable consideration to include in the transaction price. In making such estimates, we generally use the most likely amount method for milestone payments and the expected value method for other forms of variable considerations and take into account relevant development, regulatory, and other factors that can impact the level of uncertainty associated with these estimates. If it is probable that a significant revenue reversal will not occur, the estimated amount is included in the transaction price. Milestone payments that are not within our or the licensee’s control, such as regulatory approvals, are not included in the transaction price until those approvals are received. These estimates are re-assessed each reporting period and we adjust our estimate of the overall transaction price as necessary.

The consideration under the contract is allocated between the distinct performance obligations based on their respective relative stand-alone selling prices. The estimated stand-alone selling price of each performance obligation reflects our best estimate of what the selling price would be if the deliverable was regularly sold on a stand-alone basis and is determined by reference to market rates for the good or service when sold to others or by using an adjusted market assessment approach if the selling price on a stand-alone basis is not available. The determination of the stand-alone selling price often requires significant judgment. Our estimates of the stand-alone selling price for license-related performance obligations may include forecasted revenues and expenses, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical, regulatory and commercial success. Our estimates of the stand-alone selling price for research and development or other service-related performance obligations generally include forecasting the expected costs of satisfying a performance obligation at market rates. We also exercise significant judgment in allocating variable consideration that relates specifically to our efforts to satisfy one or more, but not all, performance obligations and determining whether such allocation is consistent with the overall allocation objectives within Topic 606.

The consideration allocated to each distinct performance obligation is recognized as revenue when control is transferred to the customer for the related goods or services. For performance obligations satisfied over time, we determine the measure of progress that best represents the transfer of goods or services to the customer. Revenue is recognized by measuring the progress towards complete satisfaction of the performance obligation using an input-based measure. Estimating the progress of the performance obligation requires significant management estimates, such as forecasting costs necessary to satisfy the performance obligation.

Sales-based royalties received in connection with licenses of intellectual property are subject to a specific exception in Topic 606, whereby the consideration is not included in the transaction price and recognized in revenue until the customer’s subsequent sales or usages occur. We may also be entitled to cost-share reimbursements or may be required to share profits related to our collaboration and license agreements. These amounts will be recognized when control of the related goods or services are transferred to the customer. Cost-sharing reimbursements are presented as revenue.

Research and Development Expenses

We focus on the research and development of our pipeline programs. Our research and development expenses consist of costs associated with our research and development activities including salaries, benefits, share-based compensation and other personnel costs, clinical trial costs, manufacturing costs for non-commercial products, fees paid to external service providers and consultants, facilities costs and supplies, equipment and materials used in clinical and preclinical studies and research and development. All such costs are charged to research and development expense as incurred. Payments that we make in connection with in-licensed technology for a particular research and development project that have no alternative future uses in other research and development projects or otherwise and therefore, no separate economic values, are expensed as research and development costs at the time such costs are incurred. As of December 31, 2024, we had no in-licensed technologies that had alternative future uses in research and development projects or otherwise.

We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidates. At this time, due to the inherently unpredictable nature of preclinical and clinical development, we are unable to estimate with any certainty the costs we will incur and the timelines we will require in the continued development of our product candidates and our other pipeline programs. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. Our future research and development expenses will depend on the preclinical and clinical success of each product candidate that we develop, as well as ongoing assessments of the commercial potential of such product candidates. In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

Completion of clinical trials may take several years or more, and the length of time generally varies according to the type, complexity, novelty and intended use of a product candidate. The cost of clinical trials may vary significantly over the life of a project as a result of differences arising during clinical development, including, among others:

  • per patient clinical trial costs;
  • the number of clinical trials required for approval;
  • the number of sites included in the clinical trials;
  • the length of time required to enroll suitable patients;
  • the number of doses that patients receive;
  • the number of patients that participate in the clinical trials;
  • the drop-out or discontinuation rates of patients;
  • the duration of patient follow-up;
  • potential additional safety monitoring or other studies requested by regulatory agencies;
  • the number and complexity of analyses and tests performed during the clinical trial;
  • the phase of development of the product candidate; and
  • the efficacy and safety profile of the product candidate.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries, benefits, share-based compensation and other personnel costs for employees in executive, finance, business development and support functions. Other significant general and administrative expenses include the costs associated with obtaining and maintaining our patent portfolio, professional services for audit, legal, pre-commercial planning, investor and public relations, director and officer insurance premiums, corporate activities and allocated facilities.

Other Income, Net

Other income, net consists primarily of interest income and interest expense.

Income Taxes

For the year ended December 31, 2024, we recorded current Federal and state tax provisions of $1.8 million and $0.2 million, respectively. For the years ended December 31, 2023 and 2022 we did not record a provision for income taxes due to a full valuation against our deferred taxes.

Results of Operations

Comparison of Fiscal Years Ended December 31, 2024 and 2023

The following table sets forth our results of operations for the years presented, in thousands:

Years Ended December 31,
2024 2023 Change
Collaboration revenue $ 53,883 $ $ 53,883
Research and development expenses 169,967 115,235 54,732
General and administrative expenses 77,111 50,569 26,542
Other income, net 21,230 13,173 8,057

Collaboration Revenue. We recognized collaboration revenue of $53.9 million for the year ended December 31, 2024 related to the license granted and services performed under the Kyowa Agreement entered into in November 2024.

Research and Development Expenses. The following table illustrates the components of our research and development expenses for the years presented, in thousands:

Years Ended December 31,
2024 2023 Change
Ziftomenib-related costs $ 79,338 $ 35,933 $ 43,405
KO-2806-related costs 18,829 10,629 8,200
Tipifarnib-related costs 4,770 12,190 (7,420 )
Discovery stage program-related costs 6,621 5,399 1,222
Personnel costs and other expenses 45,789 38,424 7,365
Share-based compensation expense 14,620 12,660 1,960
Total research and development expenses $ 169,967 $ 115,235 $ 54,732

The increase in ziftomenib-related research and development expenses for the year ended December 31, 2024 compared to 2023 was primarily due to increases in costs related to our registration-directed clinical trial of ziftomenib and the ziftomenib combination trials. The increase in KO-2806-related research and development expenses for the year ended December 31, 2024 compared to 2023 was primarily due to increased costs related to our Phase 1 clinical trial. The decrease in tipifarnib-related research and development expenses for the year ended December 31, 2024 compared to 2023 was primarily due to the closure of our registration-directed trial of tipifarnib. The increase in personnel costs and other expenses for the year ended December 31, 2024 compared to 2023 was primarily due to a retention tax credit recognized in the first quarter of 2023, and increases in headcount costs to support our ongoing clinical trials. We expect our research and development expenses to increase in future periods as we continue clinical development activities for our ziftomenib and FTI programs.

General and Administrative Expenses. The increase in general and administrative expenses for the year ended December 31, 2024 compared to 2023 was primarily due to increases in personnel costs, inclusive of a retention tax credit recognized in the first quarter of 2023, pre-commercial planning expenses, non-cash share-based compensation expense, and professional services. We expect our general and administrative expenses to increase in future periods to support our planned increase in research and development activities.

Other income, net. The increase in other income, net for the year ended December 31, 2024 compared to 2023 was primarily due to an increase in interest income.

Liquidity and Capital Resources

Since our inception, we have funded our operations primarily through equity and debt financings and through revenues under the Kyowa Agreement. We have devoted our resources to funding research and development programs, including discovery research, preclinical and clinical development activities.

On November 20, 2024, we entered into the Kyowa Agreement to develop and globally commercialize ziftomenib for the treatment of patients with AML and other hematologic malignancies, or the Field. In exchange for the licenses and rights granted to Kyowa Kirin to participate in the development and commercialization of ziftomenib, we received an upfront payment of $330.0 million and are eligible to receive up to an additional $933.0 million in development, regulatory and commercial milestone payments for the Field.

On January 26, 2024, we completed the Private Placement in which we sold to certain institutional accredited investors an aggregate of 1,376,813 shares of our common stock at a purchase price of $17.25 per share and pre-funded warrants to purchase up to an aggregate of 7,318,886 shares of common stock at a purchase price of $17.2499 per pre-funded warrant (representing the $17.25 per share purchase price less the exercise price of $0.0001 per warrant share). Net proceeds from the Private Placement, after deducting expenses, were approximately $145.8 million. As of December 31, 2024, pre-funded warrants to purchase 559,424 of such shares of common stock had been exercised and 6,759,462 remained outstanding.

In November 2023, we entered into the ATM Facility under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million. We have not sold any shares of our common stock under the ATM Facility.

In June 2023, we completed a public offering in which we sold an aggregate of 5,660,871 shares of common stock at a price of $11.50 per share as well as pre-funded warrants to purchase 3,034,782 shares of our common stock at a price of $11.4999 per pre-funded warrant (representing the $11.50 per share purchase price less the exercise price of $0.0001 per warrant share). Net proceeds from the public offering, after deducting underwriting discounts and commissions and offering expenses, were approximately $93.6 million. As of December 31, 2024, pre-funded warrants to purchase 860,869 of such shares of common stock had been exercised and 2,173,913 remained outstanding. On January 16, 2025, the remaining 2,173,913 pre-funded warrants were exercised.

In November 2022, we entered into the Loan Agreement with the Lenders and Hercules, in its capacity as administrative agent and collateral agent for itself and the Lenders, providing for up to $125.0 million in a series of Term Loans. Under the terms of the Loan Agreement, we borrowed $10.0 million of an initial $25.0 million Tranche 1 Loan. In September 2023, the draw period for the remaining $15.0 million of the Tranche 1 Loan expired without us drawing down such additional loan. In March 2024, the draw period for the $35.0 million second tranche of Term Loans expired without us drawing down such additional loan and in December 2024, the draw period for the (i) $40.0 million third tranche of Term Loans and (ii) $25.0 million fourth tranche of term loans expired without us drawing down such additional loans. No further Term Loans may be drawn under the Loan Agreement. All of the Term Loans have a maturity date of November 2, 2027, or the Maturity Date. Repayment of the Term Loans is interest only through (a) May 1, 2025, with the satisfaction of the Interest Only Milestone 1 Conditions (as defined in the Loan Agreement), (b) November 1, 2025, if we satisfy the Interest Only Milestone 2 Conditions (as defined in the Loan Agreement), and (c) November 1, 2026, if we satisfy the Approval Milestone (as defined in the Loan Agreement). After the interest-only payment period, borrowings under the Loan Agreement are repayable in monthly payments of principal and accrued interest until the Maturity Date. The per annum interest rate for the Term Loans is the greater of (i) the prime rate as reported in The Wall Street Journal minus 6.25% plus 8.65% and (ii) 8.65%.

At our option, we may prepay all or any portion of the outstanding Term Loans at any time. Prepayments made on or prior to the third anniversary of the date of the Loan Agreement will be subject to a prepayment fee equal to 1.50% of the principal amount being prepaid. In addition, we paid a facility charge of approximately $0.1 million upon closing and an additional approximately $0.2 million of facility charges in November 2023 due to the availability of the second tranche of the Term Loans. The Loan Agreement also provides for an end of term fee in an amount equal to the greater of approximately (i) $1.5 million (which is 6.05% of the maximum amount of the first tranche of loans) or (ii) 6.05% of the aggregate principal amount of loan advances actually made under the Loan Agreement, which fee is due and payable on the earliest to occur of (i) the Maturity Date, (ii) the date we prepay the outstanding loans in full, and (iii) the date that the secured obligations become due and payable. Our obligations under the Loan Agreement are secured by substantially all of our assets other than our intellectual property, but including proceeds from the sale, licensing or other disposition of our intellectual property. As part of the Loan Agreement, we are subject to certain negative covenants, which, among other things, prohibit us from selling, transferring, assigning, mortgaging, pledging, leasing, granting a security interest in or otherwise encumbering our intellectual property, subject to limited exceptions.

We have incurred operating losses and negative cash flows from operating activities since inception. As of December 31, 2024, we had an accumulated deficit of $895.4 million. We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, continue and initiate clinical trials of, and seek marketing approval for, our product candidates. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution to the extent that such sales, marketing and distribution are not the responsibility of collaborators or potential collaborators. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

As of December 31, 2024, we had cash, cash equivalents and short-term investments of $727.4 million. Based on our current plans, we believe our cash, cash equivalents and short-term investments as of December 31, 2024 will be sufficient to enable us to fund our current operating expenses into 2027, and combined with anticipated collaboration funding under the Kyowa Agreement, should support our ziftomenib AML program through commercialization in the frontline combination setting. Our future capital requirements will depend on many factors, including:

  • the scope, progress, results and costs of drug discovery, preclinical development, laboratory testing and clinical trials for our product candidates;

  • the costs, timing and outcome of regulatory review of our product candidates;

  • the costs of fully developing our sales, marketing and distribution capabilities if we obtain regulatory approvals to market our product candidates;

  • the costs of securing and producing drug substance and drug product material for use in preclinical studies, clinical trials and for use as commercial supply;

  • the costs of securing manufacturing arrangements for development activities and commercial production;

  • the scope, prioritization and number of our research and development programs;

  • the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under current or any future collaboration agreements;

  • the extent to which we acquire or in-license other product candidates and technologies;

  • the success of our current or future companion diagnostic test collaborations for companion diagnostic tests; and

  • the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims.

To date, we have not generated any revenues from product sales, and we do not have any approved products. We do not know when, or if, we will generate any revenues from product sales. We do not expect to generate significant revenues from product sales unless and until we obtain regulatory approval of and commercialize one of our current or future product candidates. We are subject to all of the risks incident in the development of new therapeutic products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We may need substantial additional funding in connection with our continuing operations.

Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of stock offerings, debt financings, collaborations, strategic partnerships or licensing arrangements, such as the Kyowa Agreement. Additional capital may not be available on reasonable terms, if at all. Subject to limited exceptions, our term loan facility also prohibits us from incurring indebtedness without the prior written consent of the Lenders. To the extent that we raise additional capital through the sale of stock or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve agreements that include increased fixed payment obligations and covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends, selling or licensing intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. If we raise additional funds through collaborations, strategic partnerships or licensing arrangements with third parties, such as the Kyowa Agreement, we may have to relinquish valuable rights to our product candidates, including our other technologies, future revenue streams or research programs, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be unable to carry out our business plan. As a result, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and commercialize our product candidates even if we would otherwise prefer to develop and commercialize such product candidates ourselves, and our business, financial condition and results of operations would be materially adversely affected.

The following table provides a summary of our net cash flow activities for the years presented, in thousands:

Years Ended December 31,
2024 2023 Change
Net cash provided by (used in) operating activities $ 134,317 $ (124,824 ) $ 259,141
Net cash provided by (used in) investing activities (101,590 ) 15,557 (117,147 )
Net cash provided by financing activities 154,417 94,783 59,634

Operating Activities. The increase of $259.1 million in net cash provided by operating activities for the year ended December 31, 2024 compared to 2023 was primarily due to an increase of $278.2 million in contract liabilities related to the Kyowa Agreement, offset by an increase of $21.4 million in net loss.

Investing Activities. The increase of $117.1 million in net cash used in investing activities for the year ended December 31, 2024 compared to 2023 was primarily due to an increase of $249.2 million in purchases of short-term investments, offset by an increase of $132.4 million in maturities of short-term investments.

Financing Activities. Net cash provided by financing activities for the year ended December 31, 2024 primarily related to net proceeds of approximately $145.8 million from the sale of shares of our common stock and pre-funded warrants to purchase shares of our common stock in our January 2024 Private Placement and proceeds of $8.6 million from the issuance of shares of common stock under our equity plans. Net cash provided by financing activities for the year ended December 31, 2023 was primarily due to $93.6 million in net proceeds from the sale of shares of our common stock and pre-funded warrants to purchase shares of our common stock in our June 2023 public offering.

Contractual Obligations and Commitments

The following is a summary of our significant contractual obligations and commitments as of December 31, 2024, in thousands:

Payments Due by Period
Less than 1-3 3-5 More than
Total 1 Year Years Years 5 Years
Operating leases(1) $ 9,816 $ 1,964 $ 2,715 $ 2,824 $ 2,313
Long-term debt(2) 10,000 2,332 7,668
Interest payments on long-term debt(3) 3,245 937 2,308
Total $ 23,061 $ 5,233 $ 12,691 $ 2,824 $ 2,313
  • Future minimum lease payments under our operating leases in San Diego, California and Boston, Massachusetts.
  • Principal payments under our term loan facility.
  • Interest payments on our term loan facility. The per annum interest rate for the Term Loans is the greater of (i) the prime rate as reported in The Wall Street Journal minus 6.25% plus 8.65% and (ii) 8.65%. As of December 31, 2024, the interest rate on the Term Loans was 9.90%. In addition, an end of term fee will be due in an amount equal to the greater of approximately (i) $1.5 million or (ii) 6.05% of the aggregate principal amount of loan advances actually made, payable on the earliest of the maturity date, acceleration or prepayment of the Term Loans.

Subsequent to December 31, 2024, we entered into a new lease agreement for office space in San Diego, California. See Note 16, Subsequent Events, in the Notes to Financial Statements of this Annual Report for further details.

We enter into short-term and cancellable agreements in the normal course of operations with clinical sites and CROs for clinical research studies, professional consultants and various third parties for preclinical research studies, clinical supply manufacturing and other services through purchase orders or other documentation. Such short-term agreements are generally outstanding for periods less than one year and are settled by cash payments upon delivery of goods and services. The nature of the work being conducted under these agreements is such that, in most cases, the services may be cancelled upon prior notice of 90 days or less. Payments due upon cancellation generally consist only of payments for services provided and expenses incurred, including non-cancellable obligations of our service providers, up to the date of cancellation. These payments are not included in the table of contractual obligations above.

Excluded from the table above are milestone or contractual payment obligations contingent upon the achievement of certain milestones or events if the amount and timing of such obligations are unknown or uncertain, including $4.8 million of sublicense fees incurred as of December 31, 2024. Our in-license agreements are cancelable by us with written notice within 180 days or less. We may be required to pay up to approximately $80.0 million in milestone payments, plus sales royalties, in the event that regulatory and commercial milestones under the in-license agreements are achieved.

Under the Kyowa Agreement, we will be funding the specified development activities included in the Development Plan that are planned to be conducted prior to the end of 2028, and we will share equally (50/50) with Kyowa Kirin all development costs for all other development activities in the United States included in the Development Plan (including the costs of future trials conducted under the Development Plan in the United States). We will share equally with Kyowa Kirin in any potential profits and losses arising from the commercialization of ziftomenib in the United States for the existing Field and, if Kyowa Kirin exercises the Field Expansion Option, the expanded Field.

Critical Accounting Policies and Management Estimates

The SEC defines critical accounting policies as those that are, in management’s view, important to the portrayal of our financial condition and results of operations and demanding of management’s judgment. Management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements required estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in the financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to revenue from collaborations and licenses, and clinical trial costs and accruals. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are described in more detail in Note 2 in the Notes to Financial Statements of this Annual Report, we believe the following accounting policies are critical to the judgments and estimates used in the preparation of our financial statements.

Revenue from Collaborations and Licenses

Our collaboration agreements fall under the scope of Topic 808, when there is a joint operating activity and when both parties are active participants in the arrangement and are exposed to significant risks and rewards. For our arrangements under the scope of Topic 808, we evaluate each promised good or service that is distinct in accordance with Topic 606 (i.e., a unit of account) and apply Topic 606 to those units of account that are determined to be with a customer. For all other units of account that are not within the scope of other relevant accounting topics, we analogize to other authoritative accounting literature, such as Topic 606.

In applying Topic 808 and Topic 606, we are required to make estimates of the transaction price, including variable consideration that is subject to a constraint. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur and when the uncertainty associated with the variable consideration is subsequently resolved. At the inception of arrangements that include variable consideration, we may be required to exercise significant judgment to estimate the amount of variable consideration to include in the transaction price. In making such estimates, we generally use the most likely amount method and take into account relevant development, regulatory, and other factors that can impact the level of uncertainty associated with these estimates. If it is probable that a significant revenue reversal will not occur, the estimated amount is included in the transaction price. Milestone payments that are not within our or the licensee’s control, such as regulatory approvals, are not included in the transaction price until those approvals are received. These estimates are re-assessed each reporting period and we adjust our estimate of the overall transaction price as necessary.

The consideration under the contract is allocated between the distinct performance obligations based on their respective relative stand-alone selling prices. The estimated stand-alone selling price of each performance obligation reflects our best estimate of what the selling price would be if the deliverable was regularly sold on a stand-alone basis and is determined by reference to market rates for the good or service when sold to others or by using an adjusted market assessment approach if the selling price on a stand-alone basis is not available. The determination of the stand-alone selling price often requires significant judgment. Our estimates of the stand-alone selling price for license-related performance obligations may include forecasted revenues and expenses, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical, regulatory and commercial success. Our estimates of the stand-alone selling price for research and development or other service-related performance obligations generally include forecasting the expected costs of satisfying a performance obligation at market rates. We also exercise significant judgment in allocating variable consideration that relates specifically to our efforts to satisfy one or more, but not all, performance obligations and determining whether such allocation is consistent with the overall allocation objectives within Topic 606.

Clinical Trial Costs and Accruals

We accrue clinical trial costs based on work performed. In determining the amount to accrue, we rely on estimates of total costs incurred based on enrollment, the completion of clinical trials and other events. We follow this method because we believe reasonably dependable estimates of the costs applicable to various stages of a clinical trial can be made. However, the actual costs and timing of clinical trials are highly uncertain, subject to risks and may change depending on a number of factors. Differences between the actual clinical trial costs and the estimated clinical trial costs that we have accrued in any prior period are recognized in the subsequent period in which the actual costs become known. Historically, our estimated accrued expenses have approximated actual expenses incurred; however, material differences could occur in the future.

Recently Adopted Accounting Pronouncements

See Note 2 in the Notes to Financial Statements of this Annual Report.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk.

Interest Rate Risk

We hold certain financial instruments for which a change in prevailing interest rates may cause the principal amount of the short-term investments to fluctuate. Financial instruments that potentially subject us to significant concentrations of credit risk consist primarily of cash, cash equivalents and short-term investments. We invest our excess cash primarily in U.S. Treasury securities, corporate debt securities, non-U.S. government debt securities, money market funds and U.S. Agency bonds. The primary objectives of our investment activities are to ensure liquidity and to preserve principal while at the same time maximizing the income we receive from our short-term investments without significantly increasing risk. Additionally, we established guidelines regarding approved investments and maturities of investments, which are designed to maintain safety and liquidity. For our short-term investments, we do not believe that an increase or decrease in market rates would have a significant impact on the realized values or the statements of operations and comprehensive loss. We believe that should a 10.0% change in interest rates were to have occurred on December 31, 2024, this change would not have had a material effect on the fair value of our investment portfolio as of that date. Any changes would only be realized if we sold the investments prior to maturity.

We are also subject to interest expense fluctuations through our Term Loans which, as of December 31, 2024, bear interest at a rate equal to the greater of (i) the prime rate as reported in The Wall Street Journal minus 6.25% plus 8.65% and (ii) 8.65%, and are therefore exposed to changes in interest rates through their maturity date in November 2027. For interest expense, we do not believe that an increase or decrease in the interest rate would have a significant impact on the statements of operations and comprehensive loss. We believe that should a 10.0% change in the interest rate were to have occurred on December 31, 2024, this change would not have had a material effect on interest expense as of that date.

Inflation Risk

Inflation generally affects us by increasing our clinical trial costs. We do not believe that inflation has had a material effect on our business, financial condition or results of operations during the years ended December 31, 2024, 2023 or 2022.

Item 8. Financial Statements and Supplementary Data.

The financial statements and supplementary data required pursuant to this item are included in Item 15 of this Annual Report and are presented beginning on page F-1.

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.

None.

Item 9A. Controls and Procedures.

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports required by the Exchange Act, is recorded, processed, summarized and reported within the timelines specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive and financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objectives, and in reaching a reasonable level of assurance, management was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision and with the participation of our management, including our principal executive and financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this Annual Report. Based on the foregoing, our principal executive and financial officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2024.

Management’s Report on Internal Control Over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Under the supervision and with the participation of our management, including our principal executive and financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on criteria established in the framework in Internal Control — Integrated Framework (2013 Framework) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2024.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

The effectiveness of our internal control over financial reporting as of December 31, 2024 has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in its report, which is included herein.

Changes in Internal Control Over Financial Reporting

During the quarter ended December 31, 2024, we entered into the Kyowa Agreement and began to recognize revenue. We updated the processes that constitute our internal control over revenue and financial reporting, as necessary, to accommodate related changes to our accounting procedures and business processes.

Except for the changes related to the Kyowa Agreement, there have been no changes in our internal control over financial reporting identified in connection with management’s evaluation of such internal control that occurred during our most recent quarter ended December 31, 2024 that have materially affected, or are reasonably likely to material affect, our internal control over financial reporting.

Report of Independent Registered Public Accounting Firm

To the Stockholders and the Board of Directors of Kura Oncology, Inc.

Opinion on Internal Control Over Financial Reporting

We have audited Kura Oncology, Inc.’s internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Kura Oncology, Inc. (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2024, based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the balance sheets of the Company as of December 31, 2024 and 2023, the related statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2024, and the related notes and our report dated February 28, 2025 expressed an unqualified opinion thereon.

Basis for Opinion

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the 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 audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.

Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

Definition and Limitations of Internal Control Over Financial Reporting

A company’s internal control over financial reporting is a process designed 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. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

/s/ Ernst & Young LLP

San Diego, California

February 28, 2025

Item 9B. Other Information.

None.

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

Not applicable.

Item 10. Directors, Executive Officers and Corporate Governance.

The information required by this item and not set forth below will be set forth in the sections headed “Election of Directors” and “Executive Officers” in our definitive proxy statement for our 2025 Annual Meeting of Stockholders, or Proxy Statement, to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2024, and is incorporated herein by reference.

We have adopted a written code of ethics for directors, officers, including our principal executive and financial officer and our principal accounting officer, and employees, known as the Code of Business Conduct and Ethics. The Code of Business Conduct and Ethics is available on our website at www.kuraoncology.com under the Corporate Governance section of our Investors & Media page. Our website and the information contained on, or that can be accessed through, the website will not be deemed to be incorporated by reference in, and are not considered part of, this Annual Report. We will promptly disclose on our website (i) the nature of any amendment to the Code of Business Conduct and Ethics that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions and (ii) the nature of any waiver, including an implicit waiver, from a provision of the Code of Business Conduct and Ethics that is granted to one of these specified individuals that is required to be disclosed pursuant to SEC rules and regulations, the name of such person who is granted the waiver and the date of the waiver.

We have adopted insider trading policies and procedures governing the purchase, sale and/or other dispositions of our securities by our directors, officers and employees that are reasonably designed to promote compliance with insider trading laws, rules and regulations, and listing standards applicable to us. A copy of our insider trading policy is filed with this Annual Report as Exhibit 19.1.

Item 11. Executive Compensation.

The information required by this item will be set forth in the sections headed “Executive Compensation” and “Non-Employee Director Compensation” in our Proxy Statement and is incorporated herein by reference.

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

The information required by this item will be set forth in the section headed “Security Ownership of Certain Beneficial Owners and Management” in our Proxy Statement and is incorporated herein by reference.

The information required by Item 201(d) of Regulation S-K will be set forth in the section headed “Executive Compensation” in our Proxy Statement and is incorporated herein by reference.

Item 13. Certain Relationships and Related Transactions, and Director Independence.

The information required by this item will be set forth in the sections headed “Certain Relationships and Related Party Transactions” and “Information Regarding the Board of Directors and Corporate Governance” in our Proxy Statement and is incorporated herein by reference.

Item 14. Principal Accountant Fees and Services.

The information required by this item will be set forth in the section headed “Ratification of Selection of Independent Registered Public Accounting Firm” in our Proxy Statement and is incorporated herein by reference.

Item 15. Exhibit and Financial Statement Schedules.

  1. Financial Statements. We have filed the following documents as part of this Annual Report:
Page
Report of Independent Registered Public Accounting Firm F-1
Balance Sheets F-4
Statements of Operations and Comprehensive Loss F-5
Statements of Stockholders’ Equity F-6
Statements of Cash Flows F-7
Notes to Financial Statements F-8

2. Financial Statement Schedules.

There are no financial statement schedules provided because the information called for is either not required or is shown either in the financial statements or the notes thereto.

3. Exhibits

Exhibit<br><br>Number Description Filed<br><br>Herewith Incorporated by Reference herein<br><br>from Form or<br><br>Schedule Filing Date SEC File/Reg.<br><br>Number
3.1 Amended and Restated Certificate of Incorporation of the Registrant, as amended. 8-K<br><br>(Exhibit 3.1) 6/14/2017 001-37620
3.2 Amended and Restated Bylaws of the Registrant. 8-K<br><br>(Exhibit 3.2) 6/14/2017 001-37620
4.1 Form of Common Stock certificate. 8-K<br><br>(Exhibit 4.1) 3/12/2015 000-53058
4.2 Warrant to Purchase Stock by Registrant on April 27, 2016 to Oxford Finance LLC. 10-Q<br><br>(Exhibit 4.3) 8/10/2016 001-37620
4.3 Form of Warrant Agreement issued by the Registrant on November 2, 2022 to certain Lenders. 10-K<br><br>(Exhibit 4.3) 2/23/2023 001-37620
4.4 Amended and Restated Warrant Agreement, dated as of November 29, 2022, by and between the Registrant and Hercules Capital, Inc. 10-K<br><br>(Exhibit 4.4) 2/23/2023 001-37620
4.5 Warrant Agreement, dated as of November 29, 2022, by and between the Registrant and Hercules Capital IV, L.P. 10-K<br><br>(Exhibit 4.5) 2/23/2023 001-37620
4.6 Description of Registrant’s Common Stock. 10-K<br><br>(Exhibit 4.3) 2/25/2020 001-37620
4.7 Form of Pre-Funded Warrant. 8-K<br><br>(Exhibit 4.1) 6/14/2023 001-37620
4.8 Form of Pre-Funded Warrant. 8-K<br><br>(Exhibit 4.1) 1/26/2024 001-37620
4.9*** Registration Rights Agreement, dated January 26, 2024, by and among the Registrant and the persons party thereto. 8-K<br><br>(Exhibit 10.2) 1/26/2024 001-37620
Exhibit<br><br>Number Description Filed<br><br>Herewith Incorporated by Reference herein<br><br>from Form or<br><br>Schedule Filing Date SEC File/Reg.<br><br>Number
--- --- --- --- --- ---
10.1+ Kura Oncology, Inc. Amended and Restated 2014 Equity Incentive Plan and Forms of Stock Option Agreement, Notice of Exercise and Stock Option Grant Notice thereunder. 8-K<br><br>(Exhibit 99.1) 6/7/2024 001-37620
10.2+ Form of Restricted Stock Purchase Agreement and Restricted Stock Purchase Award Notice under the Kura Oncology, Inc. Amended and Restated 2014 Equity Incentive Plan. 8-K<br><br>(Exhibit 10.2) 3/12/2015 000-53058
10.3+ Kura Oncology, Inc. 2015 Employee Stock Purchase Plan. 8-K<br><br>(Exhibit 10.3) 3/12/2015 000-53058
10.4+ Form of Indemnification Agreement by and between the Registrant and each of its directors and officers. 8-K<br><br>(Exhibit 10.4) 3/12/2015 000-53058
10.5* License Agreement, dated December 18, 2014, by and between the Registrant and Janssen Pharmaceutica NV. 10-K<br><br>(Exhibit 10.5) 2/24/2021 001-37620
10.6* Patent License Agreement, effective as of December 22, 2014, by and between the Registrant and the Regents of the University of Michigan, as amended on March 3, 2015, July 22, 2015, September 29, 2016, February 1, 2017. 10-K<br><br>(Exhibit 10.8) 2/24/2021 001-37620
10.7* Fifth Amendment to Patent License Agreement, effective as of May 24, 2017, by and between the Registrant and the Regents of the University of Michigan. 10-K<br><br>(Exhibit 10.9) 2/24/2021 001-37620
10.8+ Amended and Restated Executive Employment Agreement, effective as of January 29, 2016, by and between the Registrant and Troy E. Wilson, Ph.D., J.D. 10-K<br><br>(Exhibit 10.15) 3/17/2016 001-37620
10.9 Amendment No. 1 to License Agreement, dated June 6, 2016, by and between the Registrant and Janssen Pharmaceutica NV. 10-Q<br><br>(Exhibit 10.3) 8/10/2016 001-37620
10.10** Sixth Amendment to Patent License Agreement, effective as of August 24, 2017, by and between the Registrant and the Regents of the University of Michigan. 10-K<br><br>(Exhibit 10.23) 3/12/2018 001-37620
10.11+ Executive Employment Agreement, effective as of August 9, 2019, by and between the Registrant and Kathleen Ford. 10-Q<br><br>(Exhibit 10.3) 11/5/2019 001-37620
10.12 Office Lease Agreement, dated January 8, 2020, by and between the Registrant and BRE CA Office Owners LLC. 10-Q<br><br>(Exhibit 10.28) 2/25/2020 001-37620
10.13 Office Lease Agreement, dated March 24, 2020, by and between the Registrant and East Office Operating Limited Partnership. 10-Q<br><br>(Exhibit 10.5) 5/4/2020 001-37620
10.14 First Amendment to Office Lease Agreement, dated May 2, 2020 by and between the Registrant and BRE CA Office Owner LLC. 10-Q<br><br>(Exhibit 10.8) 5/4/2020 001-37620
Exhibit<br><br>Number Description Filed<br><br>Herewith Incorporated by Reference herein<br><br>from Form or<br><br>Schedule Filing Date SEC File/Reg.<br><br>Number
--- --- --- --- --- ---
10.15+ Amended and Restated Non-Employee Director Compensation Policy. X
10.16+ Form of International Stock Option Grant Notice, International Stock Option Agreement and International Notice of Exercise under the Kura Oncology, Inc. Amended and Restated 2014 Equity Incentive Plan. 10-Q<br><br>(Exhibit 10.2) 8/9/2023 001-37620
10.17 Second Amendment to Office Lease Agreement, dated October 27, 2020 by and between the Registrant and BRE CA Office Owner LLC. 10-Q<br><br>(Exhibit 10.2) 11/5/2020 001-37620
10.18+ Amendment to Amended and Restated Executive Employment Agreement, effective as of February 19, 2021, by and between the Registrant and Troy E. Wilson, Ph.D., J.D. 10-K<br><br>(Exhibit 10.36) 2/24/2021 001-37620
10.19+ Form of Restricted Stock Unit Award Grant Notice and Restricted Stock Unit Award Agreement under the Kura Oncology, Inc. Amended and Restated 2014 Equity Incentive Plan. 10-K<br><br>(Exhibit 10.22) 2/23/2023 001-37620
10.20+ Executive Employment Agreement, effective as of July 22, 2020, by and between the Registrant and Stephen Dale, M.D. 10-Q<br><br>(Exhibit 10.7) 5/6/2021 001-37620
10.21+ Amendment to Executive Employment Agreement, effective as of February 22, 2021, by and between the Registrant and Stephen Dale, M.D. 10-Q<br><br>(Exhibit 10.8) 5/6/2021 001-37620
10.22 Lease Agreement, dated May 11, 2021, by and between the Registrant and BP3-SD5 5510 Morehouse Drive LLC. 10-Q<br><br>(Exhibit 10.1) 8/5/2021 001-37620
10.23+ Form of International Restricted Stock Unit Award Grant Notice and International Restricted Stock Unit Award Agreement under the Kura Oncology, Inc. Amended and Restated 2014 Equity Incentive Plan. 10-K<br><br>(Exhibit 10.30) 2/24/2022 001-37620
10.24+ Executive Employment Agreement, effective as of October 18, 2021, by and between the Registrant and Teresa Bair. 10-K<br><br>(Exhibit 10.31) 2/24/2022 001-37620
10.25 Loan and Security Agreement dated as of November 2, 2022 by and between the Registrant and Hercules Capital, Inc. 8-K<br><br>(Exhibit 10.2) 11/3/2022 001-37620
10.26+ Executive Employment Agreement, effective as of August 14, 2023, by and between the Registrant and Brian Powl. 10-Q<br><br>(Exhibit 10.1) 11/2/2023 001-37620
10.27 First Amendment to Lease, dated as of August 30, 2023, by and between the Registrant and East Office Operating Limited Partnership. 10-Q<br><br>(Exhibit 10.2) 11/2/2023 001-37620
10.28 First Amendment to Loan and Security Agreement, dated as of October 2, 2023, by and between the Registrant and Hercules Capital, Inc. 10-Q<br><br>(Exhibit 10.3) 11/2/2023 001-37620
Exhibit<br><br>Number Description Filed<br><br>Herewith Incorporated by Reference herein<br><br>from Form or<br><br>Schedule Filing Date SEC File/Reg.<br><br>Number
--- --- --- --- --- ---
10.29 Sales Agreement, dated November 2, 2023, by and among the Registrant, Leerink Partners LLC and Cantor Fitzgerald & Co. 10-Q<br><br>(Exhibit 10.4) 11/2/2023 001-37620
10.30+ Kura Oncology, Inc. 2023 Inducement Option Plan, as amended, and Forms of Stock Option Grant Notice, Option Agreement and Notice of Exercise thereunder. 8-K<br><br>(Exhibit 99.1) 12/20/2024 001-37620
10.31+ Second Amendment to Amended and Restated Executive Employment Agreement, effective as of April 11, 2024, by and between the Registrant and Troy E. Wilson, Ph.D., J.D. 10-Q<br><br>(Exhibit 10.1) 8/8/2024 001-37620
10.32* Collaboration and License Agreement, dated November 20, 2024, by and among the Registrant Kyowa Kirin Co., Ltd. and Kyowa Kirin, Inc. X
10.33+*** Settlement Agreement, effective as of January 2, 2025, by and between the Registrant and Stephen Dale, M.D. X
10.34+ Third Amended & Restated Executive Employment Agreement, effective as of January 2, 2025, by and between the Registrant and Mollie Leoni, M.D. X
10.35+ Third Amended & Restated Executive Employment Agreement, effective as of January 2, 2025, by and between the Registrant and Francis Burrows, Ph.D. X
10.36 Lease, effective January 13, 2025, by and between the Registrant and HCP Life Science REIT, Inc. X
19.1 Kura Oncology, Inc. Insider Trading Policy X
23.1 Consent of Independent Registered Public Accounting Firm. X
24.1 Power of Attorney (see signature page). X
31.1 Certification of Principal Executive and Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. X
32.1 Certification of Principal Executive and Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. 1350. X
97.1 Kura Oncology, Inc. Incentive Compensation Recoupment Policy. 10-K<br><br>(Exhibit 97.1) 2/27/2024 001-37620
101.INS Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. X
101.SCH Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents. X
Exhibit<br><br>Number Description Filed<br><br>Herewith Incorporated by Reference herein<br><br>from Form or<br><br>Schedule Filing Date SEC File/Reg.<br><br>Number
--- --- --- --- --- ---
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101.INS). X
  • Indicates management contract or compensatory plan.

* Certain portions of this exhibit have been omitted pursuant to Item 601 of Regulation S-K.

** Confidential treatment has been granted with respect to certain portions of this exhibit. Omitted portions have been filed separately with the SEC.

*** Schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the SEC 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 Annual Report to be signed on its behalf by the undersigned, thereunto duly authorized.

Kura Oncology, Inc.
Date: February 28, 2025 By: /s/ Troy E. Wilson, Ph.D., J.D.
Troy E. Wilson, Ph.D., J.D.
President and Chief Executive Officer

POWER OF ATTORNEY

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Troy E. Wilson, Ph.D., J.D. and Thomas Doyle, and each of them, as his or her true and lawful attorneys-in-fact, each with full power of substitution, for him or her in any and all capacities, to sign any amendments to this Annual Report on Form 10-K and to file the same, with exhibits thereto and other documents in connection therewith, with the SEC, hereby ratifying and confirming all that each of said attorneys-in-fact or their substitute or substitutes may do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Annual 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/ Troy E. Wilson, Ph.D., J.D. President, Chief Executive Officer and <br>Chairman of the Board of Directors February 28, 2025
Troy E. Wilson, Ph.D., J.D. (Principal Executive and Financial Officer)
/s/ Thomas Doyle Senior Vice President, Finance & Accounting February 28, 2025
Thomas Doyle (Principal Accounting Officer)
/s/ Helen Collins, M.D. Director February 28, 2025
Helen Collins, M.D.
/s/ Faheem Hasnain Director February 28, 2025
Faheem Hasnain
/s/ Thomas Malley Director February 28, 2025
Thomas Malley
/s/ Diane Parks Director February 28, 2025
Diane Parks
/s/ Carol Schafer Director February 28, 2025
Carol Schafer
/s/ Mary Szela Director February 28, 2025
Mary Szela
/s/ Michael Vasconcelles, M.D. Director February 28, 2025
Michael Vasconcelles, M.D.

Report of Independent Registered Public Accounting Firm

To the Stockholders and the Board of Directors of Kura Oncology, Inc.

Opinion on the Financial Statements

We have audited the accompanying balance sheets of Kura Oncology, Inc. (the Company) as of December 31, 2024 and 2023, the related statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2024, 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 at December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2024, in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated February 28, 2025 expressed an unqualified opinion thereon.

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 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. 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.

Critical Audit Matters

The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

F-1

Clinical Trial Research and Development Expenses and Accruals

Description of <br>the Matter During 2024, the Company incurred $170.0 million for research and development expenses and as of December 31, 2024, the Company accrued $14.3 million for clinical trial research and development expenses. As described in Note 2 of the financial statements, the Company records accruals for estimated costs of research and development activities that include contract services for clinical trials. Clinical trial activities are accrued and expensed based on estimates of the period in which services and efforts are expended by contract research organizations (“CROs”) and other third parties. Estimates are determined by reviewing cost information provided by CROs and other third-party vendors, contractual arrangements with CROs and the scope of work to be performed.<br><br>Auditing management’s accounting for accrued third-party clinical trial research and development expenses is especially challenging as evaluating the progress or stage of completion of the activities under the Company’s research and development agreements is dependent upon a high volume of data from third-party service providers and internal clinical personnel.
How We <br>Addressed the <br>Matter in Our <br>Audit We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the accounting for accrued third-party clinical trial research and development expenses. This included management’s assessment of the assumptions and data underlying the accrued third-party clinical trial research and development expenses estimate.<br><br>To test the completeness of the Company’s accrued third-party clinical trial research and development expenses, among other procedures, we obtained supporting evidence of the research and development activities performed for significant clinical trials. We inspected supporting evidence of clinical trial and project status review between internal personnel and third-party service providers to corroborate the status of significant research and development activities. We performed inquiries with clinical project managers to corroborate the status of significant research and development activities. To test the appropriate measurement of accrued research and development costs, we compared the costs for a sample of transactions against the related invoices and contracts, confirmed amounts incurred to-date with third-party service providers, and performed lookback analyses. We also examined a sample of subsequent payments to evaluate the completeness of the accrued third-party clinical trial research and development expenses.

F-2

Accounting for the Kyowa Kirin collaboration and license agreement

Description of <br>the Matter The Company’s collaboration revenues are derived from a collaboration and license agreement with Kyowa Kirin Co., Ltd (“the Collaboration and License Agreement”), which primarily includes licensing intellectual property and providing research and development and other commercialization services. The Company recognized revenue of $53.9 million for the year ended December 31, 2024 and a related contract liability of $278.2 million as of December 31, 2024 related to this agreement. As discussed in Note 2 of the financial statements, the total consideration related to the Collaboration and License Agreement may include many elements such as non-refundable fees at the inception of the arrangement, cost reimbursements, milestone payments and royalties. In some circumstances, management is required to use judgment to determine whether analogies to the revenue accounting literature are appropriate for elements of collaboration arrangements. The Company also develops estimates of the stand-alone selling price for each distinct performance obligation, which involve assumptions that may require significant judgment.<br><br>Auditing the Company’s revenue recognition for the Collaboration and License Agreement was complex and required the Company to apply significant judgment, including in the assessment of appropriate authoritative guidance, determination of performance obligations, and the estimation of the standalone selling price of each distinct performance obligation. The estimates of the standalone selling price for the performance obligations relating to the license, development and commercialization services reflect management’s assumptions, which included forecasted revenues and expenses, expected development timelines, discount rates and probabilities of technical, regulatory and commercial success.
How We <br>Addressed the <br>Matter in Our <br>Audit We obtained an understanding, evaluated the design, and tested the operating effectiveness of internal controls over the Company’s process for the accounting of the Collaboration and License Agreement. For example, we tested management’s controls over the determination of appropriate authoritative guidance related to the identification of each unit of account and the determination of standalone selling price of each distinct performance obligation.<br><br>To test the accounting for revenue from the Collaboration and License Agreement, our audit procedures included, among others, obtaining and reading the Collaboration and License Agreement and evaluating management's identification of significant terms for completeness, including identification of each unit of account, and evaluating the appropriateness of management’s application of authoritative guidance. To test the estimates of standalone selling price for each distinct performance obligation, our audit procedures included, among others, evaluating management’s estimate of the standalone selling price of each distinct performance obligation. For example, we evaluated forecasted revenues and expenses, expected development timelines and probabilities of technical, regulatory and commercial success by analyzing and comparing the significant assumptions to relevant industry data, comparable companies and the Company’s communication with its collaboration partner. We also involved our valuation professionals to assist in the assessment of the methodologies and discount rates used for each distinct performance obligation. We performed a sensitivity analysis to evaluate the impact that changes in the significant assumptions would have on the estimated standalone selling prices, the allocation of the transaction price, and to revenue recognized during the period. We also tested the completeness and accuracy of the underlying data used in the valuation of the standalone selling prices including the forecasted revenues and expenses.

/s/ Ernst & Young LLP

We have served as the Company’s auditor since 2015.

San Diego, California

February 28, 2025

F-3

KURA ONCOLOGY, INC.

BALANCE SHEETS

(In thousands, except par value data)

2023
Assets
Current assets
Cash and cash equivalents 224,462 $ 37,318
Short-term investments 502,933 386,639
Prepaid expenses and other current assets 17,434 8,524
Total current assets 744,829 432,481
Property and equipment, net 1,682 1,859
Operating lease right-of-use assets 5,803 6,993
Other long-term assets 7,845 7,602
Total assets 760,159 $ 448,935
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable and accrued expenses 49,953 $ 33,757
Current operating lease liabilities 1,881 1,506
Current portion of long-term debt 2,607
Current portion of contract liabilities 24,271
Total current liabilities 78,712 35,263
Long-term debt, net of current portion 6,916 9,332
Long-term operating lease liabilities 5,190 6,362
Other long-term liabilities 1,795 705
Long-term contract liabilities 253,906
Total liabilities 346,519 51,662
Commitments and contingencies (Note 9)
Stockholders’ equity
Preferred stock, 0.0001 par value; 10,000 shares authorized;      no shares issued and outstanding
Common stock, 0.0001 par value; 200,000 shares authorized;     78,229 and 74,350 shares issued and outstanding as of      December 31, 2024 and 2023, respectively 8 7
Additional paid-in capital 1,308,290 1,119,976
Accumulated other comprehensive income (loss) 764 (1,271 )
Accumulated deficit (895,422 ) (721,439 )
Total stockholders’ equity 413,640 397,273
Total liabilities and stockholders’ equity 760,159 $ 448,935

All values are in US Dollars.

See accompanying notes to financial statements.

F-4

KURA ONCOLOGY, INC.

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except per share data)

Years Ended December 31,
2024 2023 2022
Revenue
Collaboration revenue $ 53,883 $ $
Total revenue 53,883
Operating Expenses
Research and development 169,967 115,235 92,812
General and administrative 77,111 50,569 47,053
Total operating expenses 247,078 165,804 139,865
Loss from operations (193,195 ) (165,804 ) (139,865 )
Other Income (Expense)
Interest and other income, net 22,849 14,722 4,254
Interest expense (1,619 ) (1,549 ) (229 )
Total other income, net 21,230 13,173 4,025
Loss before income taxes (171,965 ) (152,631 ) (135,840 )
Income tax expense 2,018
Net Loss $ (173,983 ) $ (152,631 ) $ (135,840 )
Net loss per share, basic and diluted $ (2.02 ) $ (2.08 ) $ (2.03 )
Weighted average number of shares used in computing <br>     net loss per share, basic and diluted 86,161 73,229 66,990
Comprehensive Loss
Net loss $ (173,983 ) $ (152,631 ) $ (135,840 )
Other comprehensive income (loss)
Unrealized gain (loss) on short-term investments 2,035 6,761 (6,243 )
Comprehensive loss $ (171,948 ) $ (145,870 ) $ (142,083 )

See accompanying notes to financial statements.

F-5

KURA ONCOLOGY, INC.

STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands)

Accumulated
Additional Other Total
Common Stock Paid-In Comprehensive Accumulated Stockholders’
Shares Par Value Capital Income (Loss) Deficit Equity
Balance as of December 31, 2021 66,572 $ 7 $ 941,359 $ (1,789 ) $ (432,968 ) $ 506,609
Issuance of common stock, net of offering costs 1,370 24,721 24,721
Share-based compensation expense 26,318 26,318
Issuance of common stock under equity plans 372 4,419 4,419
Issuance of warrants in connection with debt facility 294 294
Other comprehensive loss (6,243 ) (6,243 )
Net loss (135,840 ) (135,840 )
Balance as of December 31, 2022 68,314 7 997,111 (8,032 ) (568,808 ) 420,278
Issuance of common stock, net of offering costs 5,661 60,919 60,919
Issuance of pre-funded warrants to purchase common stock, net of offering costs 32,658 32,658
Share-based compensation expense 28,082 28,082
Issuance of common stock under equity plans 375 1,206 1,206
Other comprehensive income 6,761 6,761
Net loss (152,631 ) (152,631 )
Balance as of December 31, 2023 74,350 7 1,119,976 (1,271 ) (721,439 ) 397,273
Issuance of common stock, net of offering costs 1,377 23,087 23,087
Issuance of pre-funded warrants to purchase common stock, net of offering costs 122,726 122,726
Share-based compensation expense 33,897 33,897
Exercise of pre-funded warrants 1,420 1 1
Issuance of common stock under equity plans 1,082 8,604 8,604
Other comprehensive income 2,035 2,035
Net loss (173,983 ) (173,983 )
Balance as of December 31, 2024 78,229 $ 8 $ 1,308,290 $ 764 $ (895,422 ) $ 413,640

See accompanying notes to financial statements.

F-6

KURA ONCOLOGY, INC.

STATEMENTS OF CASH FLOWS

(In thousands)

Years Ended December 31,
2024 2023 2022
Operating Activities
Net loss $ (173,983 ) $ (152,631 ) $ (135,840 )
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Share-based compensation expense 33,897 28,082 26,318
Amortization of premium and accretion of discounts on <br>     short-term investments, net (13,141 ) (9,420 ) 1,610
Depreciation expense 848 849 759
Non-cash interest expense 523 477 73
Changes in operating assets and liabilities:
Prepaid expenses and other current assets (8,910 ) (1,960 ) (2,935 )
Contract liabilities 278,178
Accounts payable and accrued expenses 15,200 10,327 (802 )
Operating lease right-of-use and other long-term assets 947 (685 ) 571
Other long-term liabilities 758 137 184
Net cash provided by (used in) operating activities 134,317 (124,824 ) (110,062 )
Investing Activities
Purchases of short-term investments (659,048 ) (409,824 ) (270,655 )
Maturities of short-term investments 557,930 425,549 303,908
Purchases of property and equipment (472 ) (168 ) (626 )
Net cash provided by (used in) investing activities (101,590 ) 15,557 32,627
Financing Activities
Proceeds from issuances of common stock and pre-funded warrants, net of offering costs 145,813 93,577 24,721
Proceeds from issuance of stock under equity plans 8,604 1,206 4,419
Proceeds from long-term debt 10,000
Payment of fees related to issuance of long-term debt (575 )
Net cash provided by financing activities 154,417 94,783 38,565
Net increase (decrease) in cash and cash equivalents 187,144 (14,484 ) (38,870 )
Cash and cash equivalents at beginning of period 37,318 51,802 90,672
Cash and cash equivalents at end of period $ 224,462 $ 37,318 $ 51,802
Supplemental disclosure of cash flow information
Interest paid $ 1,096 $ 1,064 $ 73
Supplemental non-cash disclosures
Warrants issued in connection with debt facility $ $ $ 294

See accompanying notes to financial statements.

F-7

KURA ONCOLOGY, INC.

Notes to Financial Statements

1. Description of Business

Kura Oncology, Inc. is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Our pipeline consists of small molecule product candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes and, in general, we intend to pair our product candidates with molecular or cellular diagnostics to identify those patients most likely to respond to treatment. We are conducting clinical trials of three product candidates: ziftomenib, KO-2806 and tipifarnib. We also have additional programs that are at a discovery stage. We plan to advance our product candidates through a combination of internal development and strategic partnerships while maintaining significant development and commercial rights.

References in these Notes to Financial Statements to “Kura Oncology, Inc.,” “we,” “our” or “us,” refer to Kura Oncology, Inc.

2. Summary of Significant Accounting Policies

Use of Estimates

Our financial statements are prepared in accordance with accounting principles generally accepted in the United States. The preparation of our financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period.

Reported amounts and note disclosures reflect the overall economic conditions that are most likely to occur and anticipated measures management intends to take. Actual results could differ materially from those estimates. All revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.

Cash and Cash Equivalents

Cash and cash equivalents consist of checking, money market and highly liquid investments that are readily convertible to cash and that have an original maturity of three months or less from date of purchase. The carrying amounts approximate fair value due to the short maturities of these instruments.

Short-Term Investments

Short-term investments are marketable securities with maturities greater than three months from date of purchase that are specifically identified to fund current operations. These investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date, which reflects management’s intention to use the proceeds from sales of these securities to fund our operations, as necessary. The cost of short-term investments is adjusted for amortization of premiums or accretion of discounts to maturity, and such amortization or accretion is included in interest income. Dividend and interest income is included in interest and other income, net on the statements of operations and comprehensive loss when earned. Short-term investments are classified as available-for-sale securities and carried at fair value with unrealized gains and non-credit related losses recorded in other comprehensive income (loss) and included as a separate component of stockholders’ equity. Realized gains and losses from the sale of available-for-sale securities are determined on a specific identification basis and included in interest and other income, net on the statements of operations and comprehensive loss.

F-8

Allowance for Credit Losses

For available-for-sale securities in an unrealized loss position, we first assess whether we intend to sell, or if it is more likely than not that we will be required to sell, the security before recovery of its amortized cost basis. If either of the criteria regarding intent or requirement to sell is met, the security’s amortized cost basis is written down to fair value through earnings. For available-for-sale securities that do not meet the aforementioned criteria, we evaluate whether the decline in fair value has resulted from credit losses or other factors. In making this assessment, we consider the severity of the impairment, any changes in interest rates, market conditions, changes to the underlying credit ratings and forecasted recovery, among other factors. The credit-related portion of unrealized losses, and any subsequent improvements, are recorded in interest and other income, net on the statements of operations and comprehensive loss through an allowance account. Any impairment that has not been recorded through an allowance for credit losses is included in other comprehensive income (loss) on the statements of operations and comprehensive loss.

We elected the practical expedient to exclude the applicable accrued interest from both the fair value and amortized costs basis of our available-for-sale securities for purposes of identifying and measuring an impairment. Accrued interest receivable on available-for-sale securities is recorded in prepaid expenses and other current assets on our balance sheets. Our accounting policy is to not measure an allowance for credit loss for accrued interest receivable and to write-off any uncollectible accrued interest receivable as a reversal of interest income in a timely manner, which we consider to be in the period in which we determine the accrued interest will not be collected by us.

Concentration of Credit Risk

Financial instruments that potentially subject us to significant concentrations of credit risk consist primarily of cash, cash equivalents and short-term investments. We maintain deposits in federally insured financial institutions in excess of federally insured limits. We have established guidelines to limit our exposure to credit risk by placing investments with high credit quality financial institutions, diversifying our investment portfolio and placing investments with maturities that maintain safety and liquidity. We periodically review and modify these guidelines to maximize trends in yields and interest rates without compromising safety and liquidity.

Employee Retention Credit

Under the Coronavirus Aid, Relief, and Economic Security Act of 2020, or CARES Act, we were eligible to claim the employee retention credit, which is a refundable tax credit against certain employment taxes. For the year ended December 31, 2023, we recognized $2.8 million of employee retention credits related to wages paid to our employees from July 2020 through September 2021 within operating expenses as a reduction to personnel costs in the statements of operations and comprehensive loss. We filed for the credit with the Internal Revenue Service in the first quarter of 2023. As of December 31, 2024, an employee retention credit receivable of $2.8 million was included within prepaid expenses and other current assets on the balance sheets.

Fair Value Measurements

Fair value is defined as the exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:

  • Level 1 - Quoted prices (unadjusted) in active markets for identical assets or liabilities;

  • Level 2 - Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable;

  • Level 3 - Unobservable inputs in which little or no market activity exists, therefore requiring an entity to develop its own assumptions about the assumptions that market participants would use in pricing.

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Property and Equipment

Property and equipment are stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets. Computer software and equipment are depreciated over their estimated useful lives of three to five years. Laboratory equipment is depreciated over its estimated useful life of five years. Furniture and fixtures are depreciated over their estimated useful lives of five years. Leasehold improvements are depreciated over the lesser of the term of the related lease or the useful life of the asset.

Impairment of Long-Lived Assets

We review our long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. If such circumstances are determined to exist, an estimate of undiscounted future cash flows produced by the long-lived asset, including its eventual residual value, is compared to the carrying value to determine whether impairment exists. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written-down to their estimated fair values. For the years ended December 31, 2024, 2023 and 2022, there were no impairments of the value of long-lived assets.

Leases

We determine if an arrangement is a lease or contains lease components at inception. Short-term leases with an initial term of 12 months or less are not recorded on the balance sheet. For operating leases with an initial term greater than 12 months, we recognize operating lease right-of-use, or ROU, assets and operating lease liabilities based on the present value of lease payments over the lease term at commencement date. Operating lease ROU assets are comprised of the lease liability plus any lease payments made and excludes lease incentives. Lease terms may include options to extend or terminate when we are reasonably certain that the options will be exercised. We do not separate lease components from non-lease components. For our operating leases, we generally cannot determine the interest rate implicit in the lease, in which case we use our incremental borrowing rate as the discount rate for the lease. We estimate our incremental borrowing rate for our operating leases based on what we would normally pay to borrow on a collateralized basis over a similar term for an amount equal to the lease payments. Operating lease expense is recognized on a straight-line basis over the lease term.

If a lease is modified, the modified contract is evaluated to determine whether it is or contains a lease. If a lease continues to exist, the lease modification is determined to be a separate contract when the modification grants the lessee an additional ROU that is not included in the original lease and the lease payments increase commensurate with the standalone price for the additional ROU. A lease modification that results in a separate contract will be accounted for in the same manner as a new lease. For a modification that is not a separate contract, we reassess the lease classification using the modified terms and conditions and the facts and circumstances as of the effective date of the modification and recognize the amount of the remeasurement of the lease liability for the modified lease as an adjustment to the corresponding operating lease ROU asset.

Collaboration Arrangements

We assess whether our licensing and other agreements are collaborative arrangements within the scope of Accounting Standards Codification, or ASC, Topic 808, Collaborative Arrangements, or Topic 808, based on whether they involve joint operating activities wherein both parties actively participate in the arrangement and are exposed to significant risks and rewards of the arrangement. For arrangements that we determine are collaborations under the Scope of Topic 808, we identify each unit of account by determining which promised goods or services are distinct in accordance with ASC Topic 606, Revenue from Contracts with Customers, or Topic 606, and then determine whether a customer relationship exists for that unit of account. If we determine a unit of account within the collaborative arrangement to be with a customer, we apply our revenue recognition accounting policy as further described below. For units of account within the collaborative arrangement under Topic 808 that are not with a customer in its entirety and are not within the scope of other relevant accounting topics, we apply recognition and measurement principles based on an analogy to authoritative accounting literature or, if there is no appropriate analogy, a reasonable, rational and consistently applied accounting policy election. See Note 8, Kyowa Kirin Collaboration and License Agreement, for more details.

Revenue from Collaborations and Licenses

We recognize revenue when control of the promised goods or services is transferred to our customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services. To determine revenue recognition for arrangements that are within the scope of Topic 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the

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transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation.

For enforceable contracts with our customers, we evaluate the promises in the contract that are based on goods and services that will be transferred to the customer and determine whether those promises are both (i) capable of being distinct and (ii) distinct in the context of the contract. Arrangements that include rights to additional goods or services that are exercisable at the customer’s discretion are generally considered customer options. We assess if these customer options provide a material right to the customer and, if so, these customer options are considered performance obligations.

The transaction price may comprise of payments received under our commercial arrangements, such as licensing technology rights, and may include non-refundable fees at the inception of the arrangements, cost reimbursements, milestone payments for specific achievements designated in the agreements, and royalties on the sale of products. Profit-sharing payments to our customers are generally not for a distinct good or service and, as such, are included as a reduction of the transaction price. At the inception of arrangements that include variable consideration, we use judgment to estimate the amount of variable consideration to include in the transaction price generally using the most likely amount method. If it is probable that a significant revenue reversal will not occur, the estimated amount is included in the transaction price. Milestone payments that are not within our or the licensee’s control, such as regulatory approvals, are not included in the transaction price until those approvals are received. At the end of each reporting period, we re-evaluate estimated variable consideration included in the transaction price and any related constraint and, as necessary, we adjust our estimate of the overall transaction price. Any adjustments are recorded on a cumulative catch-up basis, which affects revenues and earnings in the period of adjustment.

We develop estimates of the stand-alone selling price for each distinct performance obligation, which involve assumptions that may require significant judgment. Our estimates of the stand-alone selling price for license-related performance obligations may include forecasted revenues and expenses, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical, regulatory and commercial success. Our estimates of the stand-alone selling price for research and development or other service-related performance obligations generally include forecasting the expected costs of satisfying a performance obligation at market rates. We allocate the transaction price, including any unconstrained variable consideration, to the performance obligations within the arrangement based on the relative stand-alone selling prices. When the variable consideration relates specifically to our efforts to satisfy one or more, but not all, performance obligations and allocating the consideration specifically to those performance obligations is consistent with the overall allocation objectives within Topic 606, we allocate the consideration entirely to those performance obligations.

We use judgment to assess the nature of the performance obligation to determine whether the performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue related to the performance obligation. If the performance obligation is satisfied over time, we evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.

The selection of the method to measure progress towards completion of over-time performance obligations is based on the nature of the products or services to be provided. Our over-time performance obligations generally involve research and development or other services provided to the customer, and we generally use a cost-to-cost measure of progress because it best depicts the transfer of control to the customer. Under a cost-to-cost measure of progress, the extent of progress towards completion is measured based on the ratio of costs incurred to date compared to the total estimated costs at completion of the performance obligation (an “input method” under Topic 606). We use judgment to estimate the total cost expected to complete the research and development or other service-related performance obligations, which include subcontractors’ costs, labor, materials, other direct costs and an allocation of indirect costs. We evaluate these cost estimates and the progress each reporting period and, as necessary, we adjust the measure of progress and related revenue recognition.

For arrangements that include sales-based or usage-based royalties, we recognize revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. For arrangements that include cost-share reimbursements or obligations to share profits, we will recognize such payments when control of the related goods or services are transferred to the customer.

Consideration received or invoices issued as stipulated in contracts prior to revenue recognition are recorded as contract liabilities in the accompanying balance sheets, classified as either current or long-term contract liabilities based on our best estimate of when such amounts will be recognized. Amounts recognized as revenue, but not yet invoiced are generally recognized as contract assets in other current assets in the accompanying balance sheets.

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Research and Development Expenses

Research and development expenses consist of costs associated with our research and development activities including salaries, benefits, share-based compensation and other personnel costs, clinical trial costs, manufacturing costs for non-commercial products, fees paid to external service providers and consultants, facilities costs and supplies, equipment and materials used in clinical and preclinical studies and research and development. All such costs are charged to research and development expense as incurred when these expenditures have no alternative future uses. We are obligated to make upfront payments upon execution of certain research and development agreements. Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future research and development activities are deferred. Such amounts are recognized as expense as the related goods are delivered or the related services are performed or such time when we do not expect the goods to be delivered or services to be performed. Payments that we make in connection with in-licensed technology for a particular research and development project that have no alternative future uses in other research and development projects or otherwise, and therefore have no separate economic value, are expensed as research and development costs at the time such costs are incurred. As of December 31, 2024, we had no in-licensed technologies that have alternative future uses in research and development projects or otherwise.

Clinical Trial Costs and Accruals

A significant portion of our clinical trial costs relate to contracts with contract research organizations, or CROs. The financial terms of our CRO contracts may result in payment flows that do not match the periods over which materials or services are provided to us under such contracts. Our objective is to reflect the appropriate clinical trial expenses in our financial statements by matching those expenses with the period in which services and efforts are expended. As part of the process of preparing our financial statements, we rely on cost information provided by our CROs concerning monthly expenses as well as reimbursement for pass through costs. We are also required to estimate certain of our expenses resulting from our obligations under our CRO contracts. Accordingly, our clinical trial expense accrual is dependent upon the timely and accurate reporting of CROs and other third-party vendors. If the contracted amounts are modified, for instance, as a result of changes in the clinical trial protocol or scope of work to be performed, we modify our accruals accordingly on a prospective basis. Revisions in the scope of a contract are charged to expense in the period in which the facts that give rise to the revision become reasonably certain. Historically, we have had no material changes in clinical trial expense that had a material impact on our results of operations or financial position.

Patent Costs

We expense all costs as incurred in connection with patent applications, including direct application fees, and the legal and consulting expenses related to making such applications, and such costs are included in general and administrative expenses on the statements of operations and comprehensive loss.

Share-Based Compensation

Our share-based awards are measured at fair value on the date of grant based upon the estimated fair value of common stock. The fair value of awards expected to vest are recognized and amortized on a straight-line basis over the requisite service period of the award less actual forfeitures. The fair value of each stock option is estimated on the date of grant using the Black-Scholes option pricing model, or Black-Scholes model, that requires the use of assumptions including volatility, expected term, risk-free rate and the fair value of the underlying common stock. We estimate the fair value of restricted stock units and performance-based restricted stock units granted based on the closing market price of our common stock on the date of grant. Actual forfeitures are applied as they occur, and any compensation cost previously recognized for awards for which the requisite service has not been completed is reversed in the period that the award is forfeited.

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Income Taxes

Income taxes are accounted for using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates applicable to taxable income in the years 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 against deferred tax assets is recorded if, based upon the weight of all available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. For uncertain tax positions that meet “a more likely than not” threshold, we recognize the benefit of uncertain tax positions in the financial statements.

Comprehensive Loss

Comprehensive loss is defined as the change in equity during the period from transactions and other events and non-owner sources. For the periods presented, accumulated other comprehensive income (loss) consisted of unrealized gains and losses on short-term investments.

Net Loss per Share

Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, which includes the shares related to outstanding pre-funded warrants, but excludes other potential common stock equivalents. Pre-funded warrants are considered outstanding for the purposes of computing basic and diluted net loss per share because shares may be issued for little additional consideration, and are fully vested and exercisable. Diluted net loss per share is calculated by dividing net loss by the weighted-average number of common shares and common stock equivalents outstanding for the period. As we have reported net loss for the years ended December 31, 2024, 2023 and 2022, dilutive net loss per common share is the same as basic net loss per common share for those periods. Common stock equivalents outstanding are comprised of stock options, restricted stock units, performance-based restricted stock units, warrants and employee stock purchase plan rights and are only included in the calculation of diluted earnings per common share when net income is reported and their effect is dilutive. Common stock equivalents outstanding as of December 31, 2024, 2023 and 2022 totaling approximately 15,430,000, 12,642,000 and 9,266,000, respectively, were excluded from the computation of dilutive weighted-average shares outstanding because their effect would be anti-dilutive.

Segment Reporting

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. We operate in a single industry segment which is the discovery and development of precision medicines for the treatment of cancer. Troy E. Wilson, Ph.D., J.D., our president and chief executive officer, who serves as the Chief Operating Decision-Maker, or CODM, reviews the operating results on an aggregate basis and manages the operations as a single operating segment in the U.S.

Recent Accounting Pronouncements

Improvements to Reportable Segment Disclosures

In November 2023, the Financial Accounting Standards Board, or FASB, issued ASU 2023-07 – Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures, which improves segment disclosure requirements, primarily through enhanced disclosure requirements for significant segment expenses. The improved disclosure requirements apply to all public entities that are required to report segment information, including those with only one reportable segment. We adopted the guidance for the fiscal year ended December 31, 2024. There was no impact on our reportable segments identified and additional required disclosures have been included in Note 15, Segment Reporting.

Improvements to Income Tax Disclosures

In December 2023, the FASB issued ASU 2023-09 – Improvements to Income Tax Disclosures (Topic 740), which improves the transparency of income tax disclosures by requiring disaggregated information about our effective tax rate reconciliation as well as information on income taxes paid. For each annual period, we will be required to disclose specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold

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(if the effect of those reconciling items is equal to or greater than 5% of the amount computed by multiplying pretax income or loss by the applicable statutory income tax rate). ASU 2023-09 is effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued. We plan to adopt the standard on December 31, 2025, and are currently evaluating the effect of the standard on our financial statements.

3. Investments

We invest in available-for-sale securities consisting of U.S. Treasury securities, money market funds, corporate debt securities, non-U.S. government debt securities and U.S. Agency bonds. Available-for-sale securities are classified as either cash and cash equivalents or short-term investments on the balance sheets.

The following tables summarize, by major security type, our short-term investments that are measured at fair value on a recurring basis, in thousands:

December 31, 2024
Maturities <br>(years) Amortized<br>Cost Unrealized<br>Gains Unrealized<br>Losses Estimated Fair Value
Cash equivalents
Money market funds 1 or less $ 200,024 $ $ $ 200,024
Short-term investments
U.S. Treasury securities 3 or less 497,172 766 497,938
U.S. Agency bonds 3 or less 4,997 (2 ) 4,995
Total short-term investments 502,169 766 (2 ) 502,933
Total $ 702,193 $ 766 $ (2 ) $ 702,957
December 31, 2023
--- --- --- --- --- --- --- --- --- --- ---
Maturities <br>(years) Amortized<br>Cost Unrealized<br>Gains Unrealized<br>Losses Estimated Fair Value
Cash equivalents
Money market funds 1 or less $ 13,590 $ $ $ 13,590
Short-term investments
U.S. Treasury securities 2 or less 300,388 395 (569 ) 300,214
Corporate debt securities 2 or less 64,591 4 (825 ) 63,770
Non-U.S. government debt securities 1 or less 15,000 (273 ) 14,727
U.S. Agency bonds 1 or less 7,931 (3 ) 7,928
Total short-term investments 387,910 399 (1,670 ) 386,639
Total $ 401,500 $ 399 $ (1,670 ) $ 400,229

Short-term investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date, which reflects management’s intention to use the proceeds from sales of these securities to fund our operations, as necessary. As of December 31, 2024 and 2023, short-term investments of $393.1 million and $336.6 million, respectively, had maturities less than one year, short-term investments of $97.3 million and $50.0 million, respectively, had maturities between one to two years, and short-term investments of $12.5 million and zero, respectively, had maturities between two to three years. Realized gains and losses were de minimis for the years ended December 31, 2024, 2023 and 2022.

As of December 31, 2024 and 2023, two available-for-sale securities with a fair market value of $10.0 million and 16 available-for-sale securities with a fair market value of $155.2 million, respectively, were in gross unrealized loss positions, none and $105.0 million of which were in a continuous unrealized loss position for greater than 12 months, respectively. We do not intend to sell these available-for-sale securities, and it is not more likely than not that we will be required to sell these securities prior to recovery of their amortized cost basis. We have no allowance for credit losses as of December 31, 2024 and 2023. Unrealized gains and losses that are not credit-related are included in accumulated other comprehensive income (loss).

Accrued interest receivable on available-for-sale securities were $3.3 million and $1.1 million as of December 31, 2024 and 2023, respectively, which were included in prepaid expenses and other current assets on the balance sheets. We have not written off any accrued interest receivables for the years ended December 31, 2024, 2023 and 2022.

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4. Fair Value Measurements

As of December 31, 2024 and 2023, we had cash equivalents and short-term investments measured at fair value on a recurring basis.

Available-for-sale securities consist of money market funds and U.S. Treasury securities, which are measured at fair value using Level 1 inputs, and corporate debt securities, non-U.S. government debt securities, and U.S. Agency bonds which are measured at fair value using Level 2 inputs. We determine the fair value of Level 2 related securities with the aid of valuations provided by third parties using proprietary valuation models and analytical tools. These valuation models and analytical tools use market pricing or prices for similar instruments that are both objective and publicly available, including matrix pricing or reported trades, benchmark yields, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids and/or offers. We validate the fair values of Level 2 financial instruments by comparing these fair values to a third-party pricing source. We did not reclassify any investments between levels in the fair value hierarchy during the periods presented.

The following tables summarize, by major security type, our cash equivalents and short-term investments that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy, in thousands:

December 31, 2024
Total Level 1 Level 2 Level 3
Cash equivalents
Money market funds $ 200,024 $ 200,024 $ $
Short-term investments
U.S. Treasury securities 497,938 497,938
U.S. Agency bonds 4,995 4,995
Total short-term investments 502,933 497,938 4,995
Total $ 702,957 $ 697,962 $ 4,995 $
December 31, 2023
--- --- --- --- --- --- --- --- ---
Total Level 1 Level 2 Level 3
Cash equivalents
Money market funds $ 13,590 $ 13,590 $ $
Short-term investments
U.S. Treasury securities 300,214 300,214
Corporate debt securities 63,770 63,770
Non-U.S. government debt securities 14,727 14,727
U.S. Agency bonds 7,928 7,928
Total short-term investments 386,639 300,214 86,425
Total $ 400,229 $ 313,804 $ 86,425 $

We believe that our term loan facility bears interest at a rate that approximates prevailing market rates for instruments with similar characteristics and, accordingly, the carrying value of the term loan facility approximates fair value. The fair value of our term loan facility is determined using Level 2 inputs in the fair value hierarchy. See Note 6, Long-Term Debt, for further discussion of our term loan facility.

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5. Balance Sheet Detail

Property and equipment consisted of the following, in thousands:

December 31,
2024 2023
Laboratory and computer equipment $ 2,004 $ 1,657
Leasehold improvements 1,743 1,543
Furniture and fixtures 1,210 1,111
Property and equipment, gross 4,957 4,311
Less: accumulated depreciation (3,275 ) (2,452 )
Property and equipment, net $ 1,682 $ 1,859

Depreciation expense was $0.8 million for each of the years ended December 31, 2024, 2023 and 2022.

Accounts payable and accrued expenses consisted of the following, in thousands:

December 31,
2024 2023
Accounts payable $ 1,469 $ 2,300
Accrued clinical trial research and development expenses 14,267 7,737
Accrued other research and development expenses 11,938 9,265
Accrued compensation and benefits 17,508 13,153
Other accrued expenses 2,710 1,302
Income taxes payable 2,061
Total accounts payable and accrued expenses $ 49,953 $ 33,757

6. Long-Term Debt

On November 2, 2022, we entered into a loan and security agreement, or Loan Agreement, with several banks and other financial institutions or entities party thereto, or collectively Lenders, and Hercules Capital, Inc., or Hercules, in its capacity as administrative agent and collateral agent for itself and the Lenders, or in such capacity, Agent, providing for up to $125.0 million in a series of term loans, or Term Loans. Under the terms of the Loan Agreement, we borrowed $10.0 million of an initial $25.0 million tranche of term loans, or the Tranche 1 Loan. On September 15, 2023, the draw period for the remaining $15.0 million of the Tranche 1 Loan expired without us drawing down the additional loan. In March 2024, the draw period for the $35.0 million second tranche of Term Loans expired without us drawing down such additional loan and in December 2024, the draw period for the (i) $40.0 million third tranche of Term Loans and (ii) $25.0 million fourth tranche of Term Loans each expired without us drawing down such additional loans. No further Term Loans may be drawn under the Loan Agreement. All of the Term Loans have a maturity date of November 2, 2027, or the Maturity Date. Repayment of the Term Loans is interest only through (a) May 1, 2025, with the satisfaction of the Interest Only Milestone 1 Conditions (as defined in the Loan Agreement), (b) if we satisfy the Interest Only Milestone 2 Conditions (as defined in the Loan Agreement), November 1, 2025, and (c) if we satisfy the Approval Milestone (as defined in the Loan Agreement), November 1, 2026. After the interest-only payment period, borrowings under the Loan Agreement are repayable in monthly payments of principal and accrued interest until the Maturity Date. The per annum interest rate for the Term Loans is the greater of (i) the prime rate as reported in The Wall Street Journal minus 6.25% plus 8.65% and (ii) 8.65%. As of December 31, 2024, the interest rate on the Term Loans was 9.90%.

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At our option, we may prepay all or any portion of the outstanding Term Loans at any time. Prepayments made on or prior to the third anniversary of the date of the Loan Agreement will be subject to a prepayment fee equal to 1.50% of the principal amount being prepaid. In addition, we paid a facility charge of approximately $0.1 million upon closing and an additional approximately $0.2 million of facility charges in November 2023 due to the availability of the second tranche of Term Loans. The Loan Agreement also provides for an end of term fee in an amount equal to the greater of approximately (i) $1.5 million (which is 6.05% of the maximum amount of the first tranche of loans) or (ii) 6.05% of the aggregate principal amount of loan advances actually made under the Loan Agreement, which fee is due and payable on the earliest to occur of (i) the Maturity Date, (ii) the date we prepay the outstanding loans in full, and (iii) the date that the secured obligations become due and payable. Our obligations under the Loan Agreement are secured by substantially all of our assets other than our intellectual property, but including proceeds from the sale, licensing or other disposition of our intellectual property. As part of the Loan Agreement, we are subject to certain negative covenants, which, among other things, prohibit us from selling, transferring, assigning, mortgaging, pledging, leasing, granting a security interest in or otherwise encumbering our intellectual property, subject to limited exceptions.

The Loan Agreement also contains a minimum cash covenant, which commenced on June 1, 2024, requiring us to hold cash in the United States and subject to a first-priority perfected security interest in favor of the Lenders in an amount greater than or equal to (x) 55.0% of the outstanding loan obligations if we have not received FDA approval for ziftomenib, or (y) 35.0% of the outstanding loan obligations if we have received FDA approval for ziftomenib, provided that neither (x) nor (y) will apply at any time our market capitalization is equal to or greater than $1,250.0 million. Additionally, the Loan Agreement contains minimum cash requirements in the event of (i) any Corporate Collaborations (as defined in the Loan Agreement) or (ii) any cash payment in respect of permitted convertible debt subject to the satisfaction of the Redemption Conditions (as defined in the Loan Agreement).

In addition, the Loan Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness, and dividends and other distributions, subject to certain exceptions. The Loan Agreement also contains events of default that are customary for financings of this type relating to, among other things, payment defaults, breach of covenants, material adverse effects, breach of representations and warranties, cross-default to material indebtedness, bankruptcy-related defaults, judgment defaults, breach of the financial covenants described above, and the occurrence of certain change of control events. Following an event of default and any applicable cure period, a default interest rate equal to the then-applicable interest rate plus 5.0% may be applied to the outstanding principal balance, and the Lenders will have the right upon notice to terminate any undrawn commitments and may accelerate all amounts outstanding under the Loan Agreement, in addition to other remedies available to them as our secured creditors. We were in compliance with all covenants of the Loan Agreement as of December 31, 2024.

In addition, in connection with the entry into the Loan Agreement, we issued warrants to certain of the Lenders, or collectively, the Warrants, to purchase up to 26,078 shares of our common stock at an exercise price of $14.38 per share, or the Warrant Shares. The Warrants may be exercised through the earlier of (i) the seventh anniversary of November 2, 2022 and (ii) the consummation of certain acquisition transactions involving us, as set forth in the Warrants. The number of Warrant Shares for which the Warrants are exercisable and the associated exercise price are subject to certain customary proportional adjustments for fundamental events, including stock splits and reverse stock splits, as set forth in the Warrants. The initial tranche 1 borrowing of $10.0 million and the warrants issued upon closing to purchase 26,078 shares of our common stock are accounted for as freestanding debt and equity financial instruments, respectively, as they are legally detachable and separately exercisable. In connection with the Loan Agreement, we recognized the initial 26,078 issued warrants at their relative fair value of approximately $0.3 million, and we incurred debt issuance costs of $0.6 million, which were recorded as debt discounts. The fair value of the warrants, debt issuance costs and end of term fee are being amortized and accreted into interest expense using the effective interest rate method over the term of the loan. As of December 31, 2024, none of the Warrants had been exercised.

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The following table summarizes maturities of principal obligation payments under the term loan facility as of December 31, 2024, in thousands:

Years Ending December 31,
2025 $ 2,332
2026 3,805
2027 3,863
Total principal outstanding 10,000
Less: unamortized discounts (477 )
Long-term debt, net $ 9,523

7. License Agreements

The University of Michigan License Agreement

In December 2014, we entered into a license agreement with the Regents of the University of Michigan, or the University of Michigan, which was amended in March 2015, July 2015, September 2016, February 2017, May 2017 and August 2017, under which we received certain license rights for a non-refundable upfront license, annual maintenance fees and payments upon achievement of certain development and sales-based milestones. The licensed asset consists of several compounds, including our development candidate ziftomenib. As between us and the University of Michigan, all future development, regulatory and commercial work on the asset will be completed fully and at our sole expense. The University of Michigan retains the right to use the asset for non-commercial research, internal and/or educational purposes, with the right to grant the same limited rights to other non-profit research institutions.

The agreement will terminate upon the last-to-expire patent rights, or may be terminated by us at any time with 90 days written notice of termination or terminated by the University of Michigan upon a bankruptcy by us, payment failure by us that is not cured within 30 days or a material breach of the agreement by us that is not cured within 60 days.

Janssen License Agreement

In December 2014, we entered into a license agreement with Janssen which was amended in June 2016, under which we received certain intellectual property rights related to tipifarnib in all indications other than virology for a non-refundable $1.0 million upfront license fee and payments upon achievement of certain development and sales-based milestones. Tipifarnib is a clinical-stage compound and all ongoing development, regulatory and commercial work will be completed fully and at our sole expense.

The agreement will terminate upon the last-to-expire patent rights or last-to-expire royalty term, or may be terminated by us with

180

days written notice of termination. Either party may terminate the agreement in the event of material breach of the agreement that is not cured within 45 days. Janssen may also terminate the agreement due to our lack of diligence that is not cured within a three-month period.

Payments under License Agreements

Collectively, our license agreements provide for specified development, regulatory and sales-based milestone payments up to a total of $80.2 million payable upon occurrence of each stated event, of which $0.5 million relates to the initiation of certain development activities, $28.9 million relates to the achievement of specified regulatory approvals for the first indication and up to $50.8 million relates to the achievement of specified levels of product sales. Additional payments will be due for each subsequent indication if specified regulatory approvals are achieved. For the year ended December 31, 2024, we incurred sublicense fees of $4.8 million. As of December 31, 2024, we have paid milestone payments totaling $0.3 million and incurred sublicense fees totaling $4.8 million. Furthermore, if all the programs are successfully commercialized, we will be required to pay tiered royalties on annual net product sales ranging from the low single digits to the low teens, depending on the volume of sales and the respective agreement.

F-18

8. Kyowa Kirin Collaboration and License Agreement

On November 20, 2024, we and Kyowa Kirin Co., Ltd. and Kyowa Kirin, Inc., or together Kyowa Kirin, entered into a Collaboration and License Agreement, or the Kyowa Agreement, to develop and commercialize globally our product candidate, ziftomenib, a potent, selective oral menin inhibitor, for the treatment, diagnosis and prevention of patients with acute myeloid leukemia, or AML, and other hematologic malignancies, and if Kyowa Kirin exercises the Field Expansion Option (as defined below), the treatment, diagnosis and prevention of all cancers, or collectively the Field.

We will lead all development, manufacturing, and regulatory activities and commercial strategy development for ziftomenib in the United States based on a development plan and budget mutually agreed upon with Kyowa Kirin and under the oversight of a joint steering committee and applicable subcommittees. In accordance with the development plan, we plan to conduct multiple phase 2 and phase 3 clinical trials of ziftomenib, as a monotherapy and in combination with other therapies, in AML and other hematologic malignancies over the next several years. The activities required by the development plan will be allocated to and conducted by both us and Kyowa Kirin. We will fund the specified development activities set forth in the initial development plan that are planned to be conducted prior to the end of 2028, and we will share with Kyowa Kirin equally (50/50) all development costs for all other development activities in the United States that are to be included in the development plan, including clinical trials and post-marketing commitments that are reasonably necessary for obtaining or maintaining regulatory approval of ziftomenib in the United States, or Development Services. In addition, we will conduct certain specified development and manufacturing activities outside the scope of the development plan at our sole cost and expense. Following regulatory approval, we will commercialize and record sales of ziftomenib in the United States, and Kyowa Kirin will have the right and responsibility to co-promote ziftomenib for up to a certain percentage of the details in the United States. In collaboration with Kyowa Kirin, we will perform commercialization activities, or Commercialization Services, in accordance with a co-created U.S. territory commercialization plan and budget. The parties will share equally all costs and expenses for, and profits or losses from, the commercialization of ziftomenib in the United States.

Kyowa Kirin will lead development, regulatory activities and commercialization for ziftomenib outside of the United States and will be solely responsible for the conduct and funding of such activities that are specific to the exploitation of ziftomenib outside of the United States. Following regulatory approval, Kyowa Kirin will be solely responsible for the conduct and funding of commercialization of ziftomenib outside of the United States (including recording sales). Kyowa Kirin is required to use commercially reasonable efforts to conduct the development of ziftomenib outside the United States in accordance with an ex-U.S. territory development plan, to achieve the development milestone events outside the United States that entitle us to receive corresponding development milestone payments, and to commercialize ziftomenib in each country outside of the United States where it has received regulatory approval. Development and commercialization activities outside of the United States will also be under the oversight of the joint steering committee and applicable subcommittees.

We will be responsible for the global manufacture and supply of ziftomenib necessary for the development and commercialization activities described above, pursuant to the terms of a supply agreement to be negotiated by the parties. Kyowa Kirin has the right to request that we conduct a manufacturing technology transfer and to take over the responsibility of commercial supply of ziftomenib outside the United States.

We granted Kyowa Kirin an exclusive license to enable or allow Kyowa Kirin to develop, manufacture, and commercialize ziftomenib within the Field outside of the United States, or the License. We also granted Kyowa Kirin rights to fulfill their responsibilities related to the Development Services and Commercialization Services as part of the joint development and commercialization of ziftomenib in the United States. In addition, Kyowa Kirin has an option to expand the licensed Field to include the development and commercialization of ziftomenib, or Field Expansion Option, which option can be exercised within a specified time period after receipt of clinical data from the planned proof-of-concept study evaluating ziftomenib and imatinib in patients with advanced gastrointestinal stromal tumors, or GIST, who are not successfully treated with imatinib. After Kyowa Kirin’s exercise of the Field Expansion Option, the Field would include the treatment, diagnosis and prevention of all cancers, including GIST and other solid tumors.

In exchange for the License and Kyowa Kirin’s rights to participate in the development and commercialization activities described above, we received an upfront payment of $330.0 million. We are eligible to receive, if Kyowa Kirin exercises the Field Expansion Option, up to an aggregate of $1.161 billion in development, regulatory, commercial milestone and additional upfront payments for the existing Field and the expanded Field, totaling up to $1.491 billion in upfront and milestone payments in the aggregate. We are also eligible to receive tiered double-digit royalties on sales of ziftomenib outside of the United States on a country-by-country basis until the latest of expiration of the last-to-expire valid claim of our patent rights licensed to Kyowa Kirin in such country, expiration of the last-to-expire regulatory exclusivity in such country and ten years after first commercial sale in such country, or the Royalty Term.

F-19

The Kyowa Agreement will remain in effect in the United States until the latest of expiration of all valid claims of our patent rights licensed to Kyowa Kirin, expiration of the last-to-expire regulatory exclusivity or ten years after first commercial sale. The Kyowa Agreement will remain in effect outside the United States until the expiration of the last-to-expire Royalty Term. Either party may terminate the Kyowa Agreement for uncured material breach by or insolvency of the other party. Kyowa Kirin may terminate the Agreement for convenience upon twelve months’ prior written notice. In addition, Kyowa Kirin has the right to terminate the Kyowa Agreement with a shorter specified notice period upon the occurrence of a material adverse regulatory event or certain other specified events. We may terminate the Kyowa Agreement if Kyowa Kirin or any of its affiliates or sublicensees challenges the validity or enforceability of any of the patent rights licensed to Kyowa Kirin by us.

Based on our analysis of the key terms and activities required by the Kyowa Agreement summarized above and given the involvement by both parties, we assessed the criteria under Topic 808 and concluded that both parties participate in a joint operating activity, are active participants, and are exposed to significant risks and rewards dependent on the commercial success of the activities. Therefore, the Kyowa Agreement was determined to be within the scope of Topic 808.

We evaluated each of the required promised goods and services and determined the Kyowa Agreement contains multiple units of account comprised of the License, Development Services related to monotherapy and in combination with other therapies, and Commercialization Services. The License is a unit of account under the scope of Topic 606 as it is reflective of a typical vendor-customer relationship, while the Development Services and Commercialization Services are under the scope of Topic 808 due to the joint participation in the services being performed and these services not being reflective of a typical vendor-customer relationship. However, we determined that Topic 606 was the most appropriate accounting model to apply by analogy to the recognition and measurement of these units of account.

We determined the upfront fixed payment amount of $330.0 million should be included in the transaction price. All variable consideration related to milestones has been fully constrained due to development, regulatory, or other factors that caused us to determine that it was not probable that a significant reversal of revenue would not occur at the contract inception date and as of December 31, 2024. We will recognize any royalties or sales-based milestones related to the License granted to Kyowa Kirin when the associated sales occur, and relevant sales-based thresholds are met. As of December 31, 2024, no royalties or sales-based milestones have been recognized.

We allocated the transaction price comprised of the upfront fixed payment to each unit of account based on their relative stand-alone selling price. Variable consideration that relates specifically to our efforts to satisfy specific performance obligations, such as certain milestones, is allocated entirely to those performance obligations. Other components of variable consideration that do not relate specifically to our efforts to satisfy specific performance obligations are allocated based on the relative stand-alone selling price. We are entitled to cost-sharing reimbursements from Kyowa Kirin for certain development and commercialization activities we perform and determined that such reimbursements are specifically related to our efforts to satisfy the respective performance obligations while satisfying the overall allocation objective required by Topic 606.

We recognized revenue allocated to the License at a point in time and upon transfer in November 2024, resulting in $49.8 million of revenue for the year ended December 31, 2024.

The consideration allocated to the Development Services for monotherapy and in combination with other therapies was $12.6 million and $90.2 million, respectively, and to Commercialization Services was $177.4 million. The allocated consideration is being recognized over time using a cost-to-cost measure of progress. We estimated the total cost expected to perform the required activities and measured the progress towards completion of each of these obligations at the reporting period. For the year ended December 31, 2024, we recognized $0.8 million of revenue from Development Services for monotherapy, $0.5 million of revenue from Development Services in combination with other therapies, and $0.7 million of revenue from Commercialization Services. For the year ended December 31, 2024, we also recognized $2.1 million of revenue from cost-share reimbursements owed to us by Kyowa Kirin, and the related receivable was included in prepaid expenses and other current assets on the balance sheet as of December 31, 2024.

As of December 31, 2024, the contract liability amount of $278.2 million represents the aggregate transaction price allocated to performance obligations that are unsatisfied under the Kyowa Agreement, $24.3 million was classified as current contract liabilities, which represents the portion of the Development Services and Commercialization Services expected to be provided over the next year, and the remaining contract liability balance of $253.9 million was classified as long-term contract liabilities.

F-20

9. Commitments and Contingencies

Operating Leases

We currently have three operating leases for administrative and research and development office and lab space in San Diego, California and Boston, Massachusetts that expire between August 2025 and July 2031. Under the terms of the operating leases, we are required to pay our proportionate share of property taxes, insurance and normal maintenance costs. Two of our leases include renewal options for an additional five years, which were not included in the determination of the ROU asset or lease liability as the renewal was not reasonably certain at the inception of the lease. Our San Diego corporate headquarters lease and our San Diego lease for lab and office space provided for $1.0 million and $0.1 million, respectively, in reimbursements for allowable tenant improvements, which effectively reduced the total lease payments owed.

In August 2023, we entered into an amendment to the lease agreement for office space in Boston, Massachusetts, or the Amendment, pursuant to which the term of the lease was extended by seven years, or the Extended Term, such that the lease will now expire in July 2031. The minimum rent payable during the Extended Term was approximately $0.1 million per month for the first year, which amount increases by 2% per year over the Extended Term. The Amendment provided (i) a rent credit in the amount of approximately $0.5 million which was applied as a credit against the rent payments due for the months of August 2023 through July 2024, inclusive, and (ii) a tenant improvement allowance in an amount not to exceed approximately $0.8 million, in each case subject to certain conditions. We elected to apply the tenant improvement allowance as a credit against the rent payments due for the months of August 2024 through March 2025, inclusive. Prior to the Amendment, we were required to maintain a standby letter of credit of approximately $0.2 million during the term of the lease. Under the terms of the Amendment, we are required to maintain a cash deposit of approximately $0.2 million during the term of the lease which was included within other long-term assets in the balance sheets.

Maturities of our lease liabilities as of December 31, 2024 are as follows, in thousands:

Years Ending December 31,
2025 $ 1,964
2026 1,344
2027 1,371
2028 1,398
2029 1,426
Thereafter 2,313
Total lease payments 9,816
Less: imputed interest (2,745 )
Total operating lease liabilities $ 7,071

As of December 31, 2024 and 2023, the weighted-average discount rate was 11.4% and 10.4%, respectively, and the weighted-average remaining lease term was

5.9

years and

6.2

years, respectively. Total cash paid for amounts included in the measurement of operating lease liabilities, net of tenant improvement reimbursements, was $1.5 million, $2.1 million and $2.3 million for the years ended December 31, 2024, 2023 and 2022, respectively. Operating lease ROU assets obtained in exchange for operating lease liabilities were $4.7 million for the year ended December 31, 2023. There were no operating lease ROU assets obtained in exchange for operating liabilities for the years ended December 31, 2024 and 2022.

Total operating lease expense and rent expense for the years ended December 31, 2024, 2023 and 2022 was approximately $1.9 million, $2.0 million and $2.0 million, respectively.

F-21

Litigation

From time to time, we may be involved in disputes, including litigation, relating to claims arising out of operations in the normal course of our business. Any of these claims could subject us to costly legal expenses and, while we generally believe that we have adequate insurance to cover many different types of liabilities, our insurance carriers may deny coverage or our policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on our results of operations and financial position. Additionally, any such claims, whether or not successful, could damage our reputation and business. We currently are not a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, would have a material adverse effect on our results of operations or financial position.

10. Stockholders’ Equity

In January 2024, we completed a private placement in which we sold to certain institutional accredited investors an aggregate of 1,376,813 shares of our common stock at a purchase price of $17.25 per share and pre-funded warrants to purchase up to an aggregate of 7,318,886 shares of common stock at a purchase price of $17.2499 per pre-funded warrant (representing the $17.25 per share purchase price less the exercise price of $0.0001 per warrant share), or the Private Placement. Net proceeds from the Private Placement, after deducting expenses, were approximately $145.8 million. The common stock and pre-funded warrants met the accounting standards guidance for equity classification, and proceeds were allocated between common stock and pre-funded warrant based on their relative fair value. As of December 31, 2024, pre-funded warrants to purchase 559,424 of such shares of common stock had been exercised and 6,759,462 remained outstanding.

In November 2023, we entered into a Sales Agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., or the ATM Facility, under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million. We have not sold any shares of our common stock under the ATM Facility.

In June 2023, we completed a public offering in which we sold an aggregate of 5,660,871 shares of common stock at a price of $11.50 per share as well as pre-funded warrants to purchase 3,034,782 shares of our common stock at a price of $11.4999 per pre-funded warrant (representing the $11.50 per share purchase price less the exercise price of $0.0001 per warrant share). Net proceeds from the public offering, after deducting underwriting discounts and commissions and offering expenses, were approximately $93.6 million. As of December 31, 2024, pre-funded warrants to purchase 860,869 of such shares of common stock had been exercised and 2,173,913 remained outstanding. On January 16, 2025, the remaining 2,173,913 pre-funded warrants were exercised.

In November 2022, we entered into a securities purchase agreement with Bristol-Myers Squibb Company, or BMS, pursuant to which BMS purchased an aggregate of 1,370,171 shares of our common stock at a purchase price of approximately $18.25 per share, for gross proceeds of approximately $25.0 million.

In November 2022, in connection with the Loan Agreement, we issued warrants to certain of the Lenders to purchase up to 26,078 shares of our common stock at an exercise price of $14.38 per share, which remained outstanding as of December 31, 2024.

In February 2022, we entered into a Sales Agreement with SVB Securities LLC, Credit Suisse Securities (USA) LLC and Cantor Fitzgerald & Co., or the 2022 Sales Agreement, under which we could offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million. We did not sell any shares of our common stock under the 2022 Sales Agreement. In November 2023, we terminated the 2022 Sales Agreement.

In connection with a loan and security agreement with Oxford Finance LLC and Silicon Valley Bank in 2016, we issued a warrant to Oxford Finance LLC to purchase up to 33,988 shares of our common stock at an exercise price of $3.31 per share, which remained outstanding as of December 31, 2024.

F-22

11. Share-Based Compensation

Equity Incentive Plan

In March 2015, our board of directors adopted our Amended and Restated 2014 Equity Incentive Plan, which was most recently amended in June 2024, or 2014 Plan, to, among other things, increase the shares available for future grant by 5,500,000 shares. The 2014 Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock unit awards, performance-based stock awards and other forms of equity compensation to our employees, consultants and members of our board of directors. We issue shares of common stock upon the exercise of options and vesting of restricted stock unit awards and performance-based restricted stock unit awards with the source of those shares of common stock being newly issued shares. As of December 31, 2024, 29,827,686 shares of common stock were reserved for issuance and 5,725,119 shares of common stock were available for grant under the 2014 Plan.

Inducement Option Plan

In December 2023, our board of directors adopted the 2023 Inducement Option Plan, which was most recently amended in December 2024, or Inducement Plan, to increase the shares available for future grant by 1,900,000 shares. The terms and conditions of the Inducement Plan are substantially similar to our 2014 Plan. As of December 31, 2024, 2,500,000 shares of common stock were reserved for issuance and 1,948,600 shares of common stock were available for grant under the Inducement Plan.

Employee Stock Purchase Plan

In March 2015, our board of directors adopted the 2015 Employee Stock Purchase Plan, or ESPP. The ESPP permits eligible employees to purchase our common stock at a discount through payroll deductions during defined six-month offering periods. Eligible employees may elect to withhold up to 15% of their base earnings to purchase shares of our common stock at a price equal to 85% of the fair market value on the first day of the offering period or the purchase date, whichever is lower. As of December 31, 2024, we had issued 345,817 shares of common stock, and 558,608 shares of common stock were reserved for future issuance under the ESPP. Share-based compensation expense related to the ESPP for the years ended December 31, 2024, 2023 and 2022 was $0.5 million, $0.3 million and $0.3 million, respectively.

Stock Options, Restricted Stock Unit Awards and Performance-Based Restricted Stock Unit Awards

Stock Options

The exercise price of all stock options granted was equal to the fair market value of such stock on the date of grant. Stock options generally vest over a four-year period. The maximum contractual term for all stock options is ten years. The following is a summary of stock option activity for the year ended December 31, 2024, in thousands (except per share and years data):

Number of<br>Options Weighted Average<br>Exercise Price <br>per Share Weighted Average<br>Remaining<br>Contractual<br>Term (years) Aggregate <br>Intrinsic <br>Value
Outstanding as of December 31, 2023 10,297 $ 16.46
Granted 3,531 $ 17.25
Exercised (593 ) $ 12.91
Canceled (332 ) $ 19.28
Outstanding as of December 31, 2024 12,903 $ 16.76 6.6 $ 551
Vested and expected to vest as of December 31, 2024 12,903 $ 16.76 6.6 $ 551
Exercisable as of December 31, 2024 7,707 $ 17.55 5.6 $ 518

The aggregate intrinsic value in the above table is calculated as the difference between the closing price of our common stock as of December 31, 2024 of $8.71 per share and the exercise price of stock options that had strike prices below the closing price.

F-23

The following summarizes certain information regarding stock options, in thousands (except per share data):

Years Ended December 31,
2024 2023 2022
Cash received from options exercised $ 7,655 $ 534 $ 3,756
Intrinsic value of options exercised $ 4,722 $ 280 $ 701
Weighted-average grant date fair value per share $ 10.05 $ 6.99 $ 8.90

As of December 31, 2024, unrecognized estimated compensation expense related to stock options was $44.0 million, which is expected to be recognized over the weighted-average remaining requisite service period of approximately

2.5

years.

Restricted Stock Unit Awards

Restricted stock unit awards, or RSUs, are share awards that, upon vesting, will deliver to the holder shares of our common stock. The RSUs generally vest annually over four years.

The following is a summary of RSU activity for the year ended December 31, 2024, in thousands (except per share and years data):

Number of<br>RSUs Weighted Average<br>Grant Date <br>Fair Value <br>per Share Weighted Average<br>Remaining<br>Vesting Period (years) Aggregate <br>Intrinsic <br>Value
Outstanding as of December 31, 2023 956 $ 14.03
Granted 703 $ 15.36
Released (394 ) $ 14.47
Canceled (139 ) $ 14.22
Outstanding as of December 31, 2024 1,126 $ 14.69 1.3 $ 9,811
Expected to vest as of December 31, 2024 1,126 $ 14.69 1.3 $ 9,811

As of December 31, 2024, unrecognized estimated compensation expense related to RSUs was $11.2 million, which is expected to be recognized over the weighted-average remaining requisite service period of approximately

2.5

years.

Performance-Based Restricted Stock Unit Awards

In May 2023, upon approval by our stockholders of our amended 2014 Plan, we granted an aggregate of 1,313,100 performance-based restricted stock units, or PSUs, to certain executives. The PSUs vest in six equal tranches upon the achievement of certain milestones and service conditions.

As of December 31, 2024, we determined that the vesting of the PSUs was not probable and therefore have not included them in share-based compensation expense or unrecognized estimated compensation expense.

Share-Based Compensation Expense

Total share-based compensation expense included on the statements of operations and comprehensive loss was comprised of the following, in thousands:

Years Ended December 31,
2024 2023 2022
Research and development $ 14,620 $ 12,660 $ 10,373
General and administrative 19,277 15,422 15,945
Total share-based compensation expense $ 33,897 $ 28,082 $ 26,318

F-24

We estimated the fair value of stock options and ESPP stock purchase rights using the Black-Scholes model based on the date of grant with the following assumptions:

Options ESPP
Years Ended December 31, Years Ended December 31,
2024 2023 2022 2024 2023 2022
Expected term (in years) 5.60 — 6.83 5.48 — 6.05 5.45 — 6.57 0.50 0.50 0.50
Expected volatility 60.0% — 63.9% 59.9% — 66.9% 67.1% — 71.9% 40.0% — 74.4% 51.0% — 52.7% 61.0% — 75.8%
Risk-free interest rate 3.5% — 4.6% 3.5% — 4.7% 1.6% — 4.2% 4.4% — 5.4% 5.4 % 1.6%— 4.6%
Expected dividend yield

Expected term. The expected term of stock options represents the period that the stock options are expected to remain outstanding. We determined our expected term assumption using our own historical exercise experience. The expected term of the ESPP stock purchase rights is six months, which represents the length of each purchase period.

Expected volatility. Expected volatility for stock options and ESPP stock purchase rights was calculated based on our historical volatility.

Risk-free interest rate. The risk-free interest rates are based on the U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the award being valued.

Expected dividend yield. The expected dividend yield of zero reflects that we have not paid cash dividends since inception and do not intend to pay cash dividends in the foreseeable future.

12. Related Party Transactions

Our president and chief executive officer is also the sole managing member and a significant stockholder of Araxes Pharma LLC, or Araxes. We had a management services agreement with Araxes pursuant to which Araxes paid us monthly fees for management services calculated based on costs incurred by us in the provision of services to Araxes, plus a reasonable mark-up. For the years ended December 31, 2024, 2023 and 2022, we recorded management fee income of approximately $0.1 million each year, which is included in interest and other income, net on the statements of operations and comprehensive loss. In addition, the agreement allowed for Araxes to reimburse us an amount equal to the number of full-time equivalents performing research and development services for Araxes, plus actual expenses as reasonably incurred. For the years ended December 31, 2024, 2023 and 2022, we did not record any reimbursements for research and development expenses provided to Araxes. The management services agreement with Araxes was terminated on December 31, 2024.

13. Employee Benefit Plan

We have a defined contribution 401(k) plan for all employees. Under the terms of the plan, employees may make voluntary contributions as a percentage or defined amount of compensation. For the years ended December 31, 2024, 2023 and 2022, we provided a safe harbor contribution of 5%, 4% and 4%, respectively, of the employee’s compensation, not to exceed eligible limits. For the years ended December 31, 2024, 2023 and 2022, we incurred approximately $1.9 million, $1.5 million and $1.2 million, respectively, in expenses related to the safe harbor contribution.

F-25

14. Income Taxes

For the year ended December 31, 2024, we recorded current Federal and state tax provisions of $1.8 million and $0.2 million, respectively. For the years ended December 31, 2023 and 2022 we did not record a provision for income taxes due to a full valuation against our deferred taxes.

Our effective income tax rate differs from the statutory federal rate of 21% for the years ended December 31, 2024, 2023 and 2022, due to the following, in thousands:

Years Ended December 31,
2024 2023 2022
Income taxes at statutory federal rate $ (36,103 ) $ (32,053 ) $ (28,526 )
State income tax, net of federal benefit (2,826 ) (11,027 ) (9,721 )
Research and development tax credits (17,418 ) (10,551 ) (6,970 )
Share-based compensation 3,425 4,125 3,998
Other 263 (332 ) (69 )
Valuation allowance 54,677 49,838 41,288
Income tax expense $ 2,018 $ $

Significant components of our deferred tax assets and liabilities are shown below, in thousands:

December 31,
2024 2023
Deferred tax assets
Net operating loss carryforwards $ 97,605 $ 144,451
Contract liabilities 66,821
Section 174 capitalization 59,497 33,947
Research and development tax credit carryforwards 41,831 31,816
Share-based compensation 9,073 8,946
Accruals 3,707 3,396
Operating lease liabilities 1,699 2,311
Other 283 1,139
Other comprehensive income 373
Total deferred tax assets 280,516 226,379
Deferred tax liabilities
Right-of-use assets (1,394 ) (2,054 )
Other comprehensive income (184 )
Other (79 ) (144 )
Total deferred tax liabilities (1,657 ) (2,198 )
Less: valuation allowance (278,859 ) (224,181 )
Net deferred tax assets $ $

As of December 31, 2024, we had federal net operating loss, or NOL, carryforwards of $252.8 million, that can be carried forward indefinitely. As of December 31, 2024, we had state loss carryforwards of $641.0 million, which will begin to expire in

2030

, unless previously utilized. We also have federal and state research and development credit carryforwards of $50.0 million and $7.9 million, respectively. The federal research and development credits will begin to expire in

2040

, unless previously utilized. Of the state research and development credits, $2.9 million will carryforward indefinitely and approximately $5.1 million will begin to expire in

2033

, unless previously utilized. We file tax returns as prescribed by the tax laws of the jurisdictions in which we operate. Our tax years since inception are subject to examination by the federal and state jurisdictions due to the carryforward of unutilized net operating losses and research and development credits. We have not been, nor are we currently, under examination by the federal or any state tax authority.

F-26

Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to use existing deferred tax assets. Based on the weight of the evidence, including our limited existence and losses since inception, management has determined that it is more likely than not that the deferred tax assets will not be realized and therefore has recorded a full valuation allowance against the deferred taxes. The valuation allowance increased by $54.7 million from December 31, 2023.

Pursuant to Sections 382 and 383 of the IRC annual use of our NOL or research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. We completed a study to assess whether an ownership change, as defined by IRC Section 382, has occurred from our formation through December 31, 2024. We determined that an ownership change occurred in 2015, but concluded the annual utilization limitation would be sufficient to utilize our pre-ownership change NOLs and research and development credits prior to expiration. Therefore we do not expect any material limitations to the utilization of NOL’s or research and development credits. Future ownership changes may limit our ability to utilize remaining tax attributes. Any carryforwards that will expire prior to utilization as a result of such additional limitations will be removed from deferred tax assets, with a corresponding reduction of the valuation allowance.

In accordance with authoritative guidance, the impact of an uncertain income tax position is recognized at the largest amount that is “more likely than not” to be sustained upon audit by the relevant taxing authority. An uncertain tax position will not be recognized if it has less than a 50% likelihood of being sustained.

The following table summarizes the activity related to our unrecognized tax benefits, in thousands:

December 31,
2024 2023 2022
Gross unrecognized tax benefits at the beginning of the year $ 10,114 $ 6,485 $ 4,402
Increases related to prior year tax positions 67 82 67
Increases from tax positions taken in the current year 5,266 3,547 2,016
Gross unrecognized tax benefits at the end of the year $ 15,447 $ 10,114 $ 6,485

Our practice is to recognize interest and penalties related to income tax matters in income tax expense. There was no accrued interest or penalties included on the balance sheets as of December 31, 2024 and 2023, and we have not recognized interest and penalties on the statements of operations and comprehensive loss for the years ended December 31, 2024, 2023 or 2022.

We do not expect that there will be a significant change in the unrecognized tax benefits over the next 12 months. Due to the existence of the valuation allowance, future changes in our unrecognized tax benefits will not impact our effective tax rate.

F-27

15. Segment Reporting

Our CODM manages our operations on an integrated basis for the purpose of allocating resources. When evaluating our financial performance, the CODM regularly reviews total revenues, total expenses, and research and development expenses by project and the CODM makes decisions using this information.

The table below is a summary of the segment profit or loss, including significant expenses, in thousands:

Years Ended December 31,
2024 2023 2022
Collaboration revenue $ 53,883 $ $
Less:
Ziftomenib-related costs 79,338 35,933 21,067
KO-2806-related costs 18,829 10,629 5,370
Tipifarnib-related costs 4,770 12,190 19,991
Discovery stage program-related costs 6,621 5,399 2,545
Research and development personnel costs and other expenses 45,789 38,424 33,466
Share-based compensation expense 33,897 28,082 26,318
Other segment expenses(1) 57,834 35,147 31,108
Total operating expenses 247,078 165,804 139,865
Other income (expenses)
Interest and other income, net 22,849 14,722 4,254
Interest expense (1,619 ) (1,549 ) (229 )
Income tax expense (2,018 )
Segment and net loss $ (173,983 ) $ (152,631 ) $ (135,840 )
  • Other segment expenses are comprised of general and administrative expenses, excluding share-based compensation expense, which is shown separately.

16. Subsequent Event

On January 13, 2025, we entered into a lease agreement, or the Lease, with HCP Life Science REIT, Inc., or the Landlord, for the lease of approximately 32,512 square feet of rentable area of the building located at 4930 Directors Place, San Diego, California 92121, or the Premises. The commencement date of the Lease is expected to be the earlier to occur of (i) the date upon which we first commence to conduct business in the Premises and (ii) October 1, 2025. We expect to use the Premises as our new principal executive offices and for general office use, research and development, and laboratory uses. The term of the Lease, or the Initial Term, is seven years and eight months and we have one option to extend the Lease for a period of five additional years. The minimum rent payable by us under the Lease will be approximately $184,000 per month for the first year of the Lease, which amount will increase by 3.0% per year over the Initial Term. We will also be responsible for the payment of additional rent to cover our share of the annual operating expenses of the building, the annual tax expenses of the building and the annual utilities costs for the building, or the Additional Rent. Pursuant to the Lease, Landlord shall provide us with (i) base rent abatement in the total amount not to exceed approximately $2.4 million to be applied as a credit against the rent payments due for months two through fourteen, inclusive and (ii) a tenant improvement allowance in an amount not to exceed $6.2 million, subject to certain conditions. In the event of a default of certain of our obligations under the Lease, Landlord would have the right to terminate the Lease and recover certain unpaid rent and expenses. We have the option to terminate the lease five years and six months into the Initial Term, or the Early Termination Date, by providing notice at least 12 months in advance of the Early Termination Date and paying an early termination fee equal to the rent, including Landlord’s estimate of Additional Rent, that otherwise would be due for the eight months following the Early Termination Date.

F-28

EX-10.15

Exhibit 10.15

Amended and Restated Non-Employee Director Compensation Policy

Each member of the Board of Directors (the “Board”) who is not also serving as an employee of Kura Oncology, Inc. (“Kura”) or any of its subsidiaries (each such member, an “Eligible Director”) will receive the compensation described in this Amended and Restated Non-Employee Director Compensation Policy (this “Policy”) for his or her Board service. This Policy is effective as of December 16, 2024 (the “Effective Date”) and may be amended at any time in the sole discretion of the Board or the Compensation Committee of the Board.

Annual Cash Compensation

The annual cash compensation amount set forth below is payable in equal quarterly installments, payable in arrears on the last day of each fiscal quarter in which the service occurred. If an Eligible Director joins the Board or a committee of the Board at a time other than effective as of the first day of a fiscal quarter, each annual retainer set forth below will be pro-rated based on days served in the applicable fiscal year, with the pro-rated amount paid for the first fiscal quarter in which the Eligible Director provides the service, and regular full quarterly payments thereafter. All annual cash fees are vested upon payment.

1. Annual Board Service Retainer:

a. All Eligible Directors: $45,000

2. Annual Committee Member Service Retainer:

a. Member of the Audit Committee: $10,000

b. Member of the Compensation Committee: $7,500

c. Member of the Nominating & Governance Committee: $5,000

3. Annual Committee Chair Service Retainer (in addition to Committee Member Service Retainer):

a. Chairman of the Audit Committee: $10,000

b. Chairman of the Compensation Committee: $7,500

c. Chairman of the Nominating & Governance Committee: $5,000

4. Annual Lead Independent Director Service Retainer: $27,500

Equity Compensation

The equity compensation set forth below will be granted under the Kura Oncology, Inc. Amended and Restated 2014 Equity Incentive Plan (the “Plan”). All stock options granted under this Policy will be nonstatutory stock options, with an exercise price per share equal to 100% of the Fair Market Value (as defined in the Plan) of the underlying common stock of Kura on the date of grant, and a term of ten years from the date of grant (subject to earlier termination in connection with a termination of service as provided in the Plan, provided that upon a termination of service

other than for death, disability or cause, the post-termination exercise period will be 12 months from the date of termination).

  1. Initial Grant: On the date of the Eligible Director’s initial election to the Board, for each Eligible Director who is first elected to the Board on or following the Effective Date (or, if such date is not a market trading day, the first market trading day thereafter), the Eligible Director will be automatically, and without further action by the Board or Compensation Committee of the Board, granted a stock option for 57,000 shares (the “Initial Grant”). The shares subject to each Initial Grant will vest in equal annual installments over a three year period such that the option is fully vested on the third anniversary of the date of grant, subject to the Eligible Director’s Continuous Service (as defined in the Plan) through each such vesting date and will vest in full upon a Change in Control (as defined in the Plan).

  2. Annual Grant: On the date of each Kura’s annual stockholder meeting held after the Effective Date, for each Eligible Director who continues to serve as a non-employee member of the Board (or who is first elected to the Board at such annual stockholder meeting), the Eligible Director will be automatically, and without further action by the Board or Compensation Committee of the Board, granted a stock option for 28,500 shares (the “Annual Grant”). In addition, each Eligible Director who is first elected to the Board following (i) the Effective Date and (ii) the date of Kura’s first annual stockholder meeting, and other than at an annual stockholder meeting will be automatically, and without further action by the Board or Compensation Committee of the Board, granted an Annual Grant, pro-rated for the number of months remaining until the next annual stockholder meeting. The shares subject to the Annual Grant will vest on the one year anniversary of the date of grant, subject to the Eligible Director’s Continuous Service (as defined in the Plan) through such vesting date and will vest in full upon a Change in Control (as defined in the Plan).

Compensation Limit

Notwithstanding anything to the contrary herein, the aggregate value of all compensation granted or paid, as applicable, to any individual for service as an Eligible Director with respect to any period commencing on the date of the Company’s Annual Meeting of Stockholders for a particular year and ending on the day immediately prior to the date of the Company’s Annual Meeting of Stockholders for the next subsequent year (the “Annual Period”), including equity awards granted and cash fees paid by the Company to such Eligible Director, will not exceed (i) $750,000 in total value or (ii) $1,000,000 in total value in the event such Eligible Director is first appointed or elected to the Board during such Annual Period, in each case calculating the value of any equity awards based on the grant date fair value of such equity awards for financial reporting purposes (the “Compensation Limit”). The Company shall have the sole discretion to reduce any compensation contemplated hereunder in order to comply with the Compensation Limit. The Compensation Limit will apply commencing with the Annual Period that begins on the Company’s 2023 Annual Meeting of Stockholders.

EX-10.32

Exhibit 10.32

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT KURA ONCOLOGY, INC. TREATS AS PRIVATE OR CONFIDENTIAL

CONFIDENTIAL Execution Version

Collaboration and license AGREEMENT

This Collaboration and License Agreement (this “Agreement”) is made as of November 20, 2024 (the “Effective Date”), by and between (a) Kura Oncology, Inc., a Delaware corporation (“Kura”), on the one hand, and (b) Kyowa Kirin Co., Ltd., a Japanese corporation (“KKJP”) and Kyowa Kirin, Inc., a Delaware corporation and wholly-owned subsidiary of KKJP (“KKUS”, and together with KKJP, “KKC”), on the other hand. Kura and KKC are referred to in this Agreement individually as a “Party” and collectively as the “Parties.”

RECITALS

WHEREAS, Kura is a clinical-stage biopharmaceutical company having experience developing small molecule precision medicines for the treatment of cancer, including a menin inhibitor known as ziftomenib;

WHEREAS, KKC is a global pharmaceutical company having experience in the development, manufacture and commercialization of pharmaceutical products, with KKUS having experience in the development, manufacture and commercialization of pharmaceutical products in the United States;

WHEREAS, the Parties wish to enter into a collaboration to further develop, manufacture and commercialize ziftomenib worldwide on the terms and conditions set forth in this Agreement; and

WHEREAS, Kura wishes to grant to KKC, and KKC wishes to obtain, a license under certain intellectual property rights of Kura, for KKUS to co-develop and co-commercialize with Kura ziftomenib in the United States, and for KKC to develop and commercialize ziftomenib outside the United States, all in accordance with the terms and conditions set forth below.

AGREEMENT

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

  • Definitions

Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, shall have the respective meanings set forth below:

  • “7+3 Indication” means the 7+3 KMT2A Indication or 7+3 NPM1 Indication.

  • “7+3 KMT2A Indication” means the use of the Product together with the combination regimen of cytarabine and daunorubicin in patients with newly-diagnosed KMT2A-rearranged AML.

  • “7+3 NPM1 Indication” means the use of the Product together with the combination regimen of cytarabine and daunorubicin in patients with newly-diagnosed NPM1-mutant AML.

  • “Accounting Standards” means, as applicable to a Party, its Affiliates or other Person, either U.S. Generally Accepted Accounting Principles (GAAP) or the International Financial Reporting Standards (IFRS).

  • “Acquired Entity” has the meaning set forth in Section 2.10(b)(2).

  • “Acquirer” has the meaning set forth in Section 2.10(b)(1).

  • “Acquiring Party” has the meaning set forth in Section 2.10(b)(2).

  • “Adverse Event” means any unwanted or harmful medical occurrence in a patient or subject who is administered a Product, whether or not considered related to such Product, including any undesirable sign (including abnormal laboratory findings of clinical concern).

  • “Advertising and Promotion” means the advertising and promotion of Products in the U.S. Territory, through any means, including (a) advertisements appearing in journals, newspapers, magazines or other media, including direct mail and electronic media, (b) seminars and conventions, including exhibit booths, and associated activities, (c) sample packages of Products, promotional literature, visual aids, three dimensional promotional items, and other selling materials, (d) symposia and opinion leader development activities and peer-to-peer speaking programs, and (e) payer pre-approval and post-approval information exchange; provided, however, that such term shall exclude direct field force activity.

  • “Advertising and Promotion Expenses” means, with respect to a Product and a given Calendar Quarter, the costs (excluding Allocable Overhead Costs or any other overhead costs) incurred by a Partnership Party or its Affiliate (on behalf of such Partnership Party), or for its or their account, in accordance with the U.S. Territory Commercialization Plan and Budget which are specifically identifiable to the Advertising and Promotion of such Product in the U.S. Territory.

  • “Affiliate” means, with respect to a specified Person, any entity that directly or indirectly in each case controls, is controlled by or is under common control with such Person. As used in this Section 1.11, “control” (and, with correlative meanings, the terms “controlled by” and “under common control with”) means, in the case of a corporation, the ownership of more than fifty percent (50%) of the outstanding voting securities thereof or, in the case of any other type of entity, an interest that results in the ability to direct or cause the direction of the management and policies of such entity or the power to appoint more than fifty percent (50%) of the members of the governing body of the entity or, where ownership of more than fifty percent (50%) of such securities or interest is prohibited by law, ownership of the maximum amount legally permitted; provided that the Collaboration Partnership shall not be considered a “Person” for these purposes.

  • “Agreement” has the meaning set forth in the preamble.

  • “Alliance Manager” has the meaning set forth in Section 3.1.

  • “Allocable Overhead Costs” means, with respect to a Product and a given Calendar Quarter, all general and administrative overhead costs of the functions that directly support the promotion of such Product in the Field in the U.S. Territory by a Partnership Party, including costs reasonably attributable to compliance, account administration, accounts payable and receivables management, interest on working capital associated with inventory and receivables of such Product in the U.S. Territory, and Out-of-Pocket Expenses incurred for legal and accounting functions, in each case incurred in accordance with the U.S. Territory Commercialization Plan and Budget.

  • “AML” means acute myeloid leukemia.

  • “Anti-Corruption Laws” has the meaning set forth in Section 10.5(a)(i).

  • “Anticipated Approval Date” has the meaning set forth in Section 5.3.

  • “Antitrust Laws” means any and all Applicable Laws that are designed to prohibit, restrict or regulate actions having the purpose or effect of monopolization or abuse of dominance, lessening of competition or restraint of trade, including the Hart-Scott-Rodino Antitrust Improvements Act, the Sherman Act, the Clayton Act, and the Federal Trade Commission Act, each as amended and including the rules and regulations promulgated thereunder, and other antitrust, competition or trade regulation laws of any jurisdiction other than the United States.

  • “Applicable Laws” means all statutes, ordinances, regulations, sub-regulatory guidance, rules, guidance, alerts, advisory bulletins or orders of any kind whatsoever having the effect of law of any Governmental Authority that may be in effect from time to time and applicable to the relevant activities contemplated by this Agreement, including, but not limited, Anti-Corruption Laws, Antitrust Laws, Data Protection Laws, the applicable standards contained in cGMP, GCP, GLP, labeling and promotional and other commercial standards as promulgated by the FDA and all analogous guidelines promulgated by the MHLW (in the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs), EMA or the ICH, as applicable, as well as the federal health care program anti-kickback statute (42 U.S.C. §1320a-7b), other federal and state anti-fraud statutes, ordinances, rules and regulations of any Governmental Authority including the MHLW, other statutes, ordinances, rules and regulations related to the sales, promotion, advertising and distribution of pharmaceutical and/or therapeutic products and statutes, ordinances, rules and regulations governing interactions with purchasers and users of such products, individuals and entities that arrange for or recommend the purchase or use of such products or individuals and entities that pay for or reimburse for such products.

  • “Audited Party” has the meaning set forth in Section 8.10(b).

  • “Auditing Party” has the meaning set forth in Section 8.10(b).

  • “Authorized Generic” means, with respect to a Product in a country in the Territory, any pharmaceutical product that [***].

  • “Authorized Generic Election Notice” has the meaning set forth in Section 2.9.

  • “Authorized Generic Election Period” has the meaning set forth in Section 2.9.

  • “Authorized Generic Negotiation Period” has the meaning set forth in Section 2.9.

  • “Baseball Arbitration Matter” has the meaning set forth in Schedule 1.204.

  • “Baseball Arbitration Notice” has the meaning set forth in Schedule 1.204.

  • “Baseball Arbitrator” has the meaning set forth in Schedule 1.204.

  • “Business Day” means a day other than Saturday, Sunday or any day on which banks located in San Diego, California or Tokyo, Japan are authorized or obligated by Applicable Law to remain closed. Whenever this Agreement refers to a number of days, such number shall refer to calendar days unless Business Days are specified.

  • “Calendar Quarter” means each respective period of three (3) consecutive calendar months ending on March 31st, June 30th, September 30th and December 31st; provided that (a) the first Calendar Quarter of the Term will extend from the Effective Date to the end of the first full Calendar Quarter thereafter, and (b) the last Calendar Quarter of the Term will commence on the last-to-occur of any of the foregoing dates during the Term and end upon the expiration or termination of this Agreement.

  • “Calendar Year” means each respective period of twelve (12) consecutive months commencing on January 1st and ending December 31st, except for the first Calendar Year of the Term which shall begin on the Effective Date and end on December 31st.

  • “cGMP” means all applicable current Good Manufacturing Practices including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 4, 210 and 211, (b) European Community Directive 2003/94/EC (Principles and guidelines of good manufacturing practice for medicinal products), (c) MHLW Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs, (d) the principles detailed in the ICH Q7 guidelines, and (e) the equivalent Applicable Laws in any relevant country or region, each as may be amended and applicable from time to time.

  • “Change of Control” means, with respect to a Party, that: (a) any Third Party acquires directly or indirectly the beneficial ownership of any voting security of such Party, or if the percentage ownership of such Third Party in the voting securities of such Party is increased through stock redemption, cancellation, or other recapitalization, and immediately after such acquisition or increase such Third Party is, directly or indirectly, the beneficial owner of voting securities representing more than fifty (50%) of the total voting power of all of the then outstanding voting securities of such Party; (b) a merger, consolidation, recapitalization, or reorganization of such Party is consummated which results in shareholders or equity holders of such Party immediately prior to such transaction, no longer owning at least fifty (50%) of the outstanding voting securities of the surviving entity (or its parent entity) immediately following such transaction; or (c) there is a sale or transfer to a Third Party of all or substantially all of such Party’s consolidated assets taken as a whole, in each case through one or more related transactions.

  • “Claims” has the meaning set forth in Section 11.1.

  • “Clinical Quality Agreement” has the meaning set forth in Section 7.1(f).

  • “Clinical Supply Agreement” has the meaning set forth in Section 7.1(b).

  • “Clinical Trial” means any clinical testing of a Product in human subjects.

  • “CMC Development Activities” has the meaning set forth in Section 4.3.

  • “CMO” means any Third Party contract manufacturing organization.

  • “CMO CDA” has the meaning set forth in Section 7.1(h).

  • “Co-Promotion” or “Co-Promote” means those Detailing, marketing and promotional activities (including performing Sales Calls), under the same Kura Product Mark, with respect to a Product undertaken by personnel of Kura or KKUS to encourage appropriate prescribing of such Product in the U.S. Territory.

  • “Co-Promotion Agreement” has the meaning set forth in Section 5.5.

  • “Collaboration Indications” means each of (a) AML and (b) acute lymphoblastic leukemia (“ALL”).

  • “Collaboration Partnership” has the meaning set forth in Section 8.13(a).

  • “Combination Clinical Trial” means any Clinical Trial of a Combination Product or combination therapy for an indication for which a Product (either as a monotherapy or as part of another Combination Product or combination therapy) is being Developed or Commercialized by or on behalf of a Party or the Parties jointly under this Agreement.

  • “Combination Product” means a Product that is comprised of or contains the Compound as an active ingredient, together with one (1) or more other clinically or pharmacologically active ingredients (which term excludes, for clarity, compendial grade excipients, controlled-release compositions, materials to increase bioavailability, solubility or stability, or delivery means) in a single formulation or final package presentation for sale as a single unit (including separate unit doses so configured). The Compound portion of any Combination Product shall be deemed the “Licensed Component” and each other clinically or pharmacologically active ingredient of such Combination Product, an “Other Component”.

  • “Commercial Budget” has the meaning as set forth in Section 5.2.

  • “Commercial Quality Agreement” has the meaning set forth in Section 7.1(f).

  • “Commercial Supply Agreement” has the meaning as set forth in Section 7.1(d).

  • “Commercialization,” “Commercialized” or “Commercialize” means all activities directed to marketing, distribution, promotion, detailing, sale or booking of sales, selling or distributing of pharmaceutical products (including importing and exporting activities in connection therewith), but excluding activities directed to Manufacturing and Medical Affairs.

  • “Commercially Reasonable Efforts” means, with respect to a Party in relation to an obligation under this Agreement with respect to the Development, Manufacture or Commercialization of a Product, such efforts that are consistent with the efforts and resources normally used by such Party in the exercise of its commercially reasonable business practices, relating to performance of an obligation for a similar compound or product (including the Development, Manufacture or Commercialization of a compound or product), as applicable, at a similar stage in its development or commercial life as the Product, taking into account issues of intellectual property coverage, scientific data/validation, safety and efficacy, stage of development, product profile, competitive products in the marketplace or under development, proprietary position, regulatory exclusivity, anticipated or approved labeling, present and future market and commercial potential, the likelihood of receipt of Regulatory Approval, profitability (including pricing and reimbursement status achieved or likely to be achieved), amounts payable to Third Party licensors

  • of Patents or other intellectual property rights, and legal issues, but [***]. It is understood that such level of efforts or resources may change from time to time based upon changing scientific, business and marketing and return on investment considerations.

  • “Committee” means the JSC, JDC, JCC, or any other subcommittee established by the JSC, as applicable.

  • “Competing Activities” has the meaning set forth in Section 2.10(b)(1).

  • “Competing Product” means any molecule that is not the Compound or Product, in free form, conjugated or complexed with delivery moieties or components (e.g., antibodies), wherein the said molecule is Directed to [***]. For clarity, Competing Product shall include any Generic Product other than an Authorized Generic.

  • “Compound” means (a) ziftomenib, an oral small molecule inhibitor having the structure set forth in Schedule 1.55; (b) any compound that (i) is Directed to the interaction of the protein menin and the protein expressed by KMT2A and (ii) is Covered by the Ziftomenib Composition Patents, and (c) any metabolite, salt, polymorph, hydrate, semihydrate or degradant of the compound described in the foregoing clause (a) or (b).

  • “Confidential Information” means any and all Know-How and other confidential or proprietary information that is disclosed by or on behalf of a Party (the “Disclosing Party”) or its Affiliates to the other Party (the “Receiving Party”), during the Term of this Agreement or pursuant to the Confidentiality Agreement, either directly or indirectly, whether in oral, written, graphic, electronic or other form. The terms of this Agreement that are not publicly disclosed through a press release or by filings to financial regulatory authorities in accordance with this Agreement and all Joint Inventions and Joint Patents shall be the Confidential Information of both Parties.

  • “Confidentiality Agreement” means the Mutual Non-Disclosure Agreement between the Parties dated as of [***].

  • “Control” or “Controlled” means, with respect to any Know-How, Patents or other intellectual property rights, that a Party has the legal authority or right (whether by ownership, license or otherwise, but without taking into account any license granted by one Party to the other Party pursuant to this Agreement) to grant a license, sublicense, access or right to use (as applicable) under such Know-How, Patents, or other intellectual property rights, on the terms and conditions set forth herein, in each case without breaching the terms of any agreement with a Third Party; provided that (a) with respect to any Know-How, Patents or other intellectual property rights of a Third Party, a Party shall not Control any such Know-How, Patents or other intellectual property rights unless such Know-How, Patents or other intellectual property rights [***], and (b) in the event a Change of Control of a Party after the Effective Date, any Know-How, Patents or other intellectual property rights Controlled by any Affiliate of such Party that was not an Affiliate of such Party immediately prior to such Change of Control transaction shall not be deemed “Controlled” by such Party except to the extent such Know-How, Patent or other intellectual property right [***].

  • “Controller” means the Party that determines the means and purposes of Processing Personal Data.

  • “Cost Sharing Agreement” means a cost sharing agreement within the meaning of the Treasury Regulations (26 CFR §1.482-7(b)) to be executed between KKUS and KKJP and effective as of the Effective Date.

  • “Cover”, “Covering” or “Covered” means, with respect to a given product or method in a given country and a given Patent, that in the absence of ownership of, a license granted under or other right to use, and in the absence of the benefit of the safe harbor provision under 35 U.S.C. Section 271(e)(1) or Applicable Law, the Development, Manufacture, registration, use or Commercialization of such product (as applicable) or the practice of such method would infringe one or more Valid Claims of such Patent (or, in the case of a claim of a pending patent application which contains a Valid Claim, would infringe such claim if it were a claim of an issued patent).

  • “Critical Matter” means (a) initial versions of each of the [***]; (b) any material updates or changes to the [***]; (c) any approval of a request by a Party to [***]; (d) any amendment of the [***]; (e) disputes regarding whether [***]; (f) any designation of any [***]; and (g) any dispute regarding whether any [***].

  • “Data Breach” has the meaning set forth in Section 10.7(b)(ii).

  • “Data Protection Laws” means any Applicable Laws governing the Processing of the relevant Personal Data under the Agreement including, as and where applicable to the Processing of relevant Personal Data under this Agreement, the GDPR, the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act adopted as part of the American Recovery and Reinvestment Act of 2009, and any regulations promulgated thereunder, and the FDA’s regulatory guidance, to the extent binding on a Party, pertaining to informed consent or cybersecurity requirements.

  • “Detail,” “Detailed” or “Detailing” means a presentation of a Product in a face-to-face, phone or video meeting in an individual or group practice setting between a Sales Representative and a Target Prescriber in which one or more key product benefits are verbally presented. Details shall be measured by a Party’s internal recording of such activity; provided that such measurement shall be on the same basis as the recording Party’s measurement for its Sales Representatives’ detailing of such recording Party’s other products, as applicable, consistently applied throughout the U.S. Territory Term. If a Party has no other marketed products, it will establish a basis of internal recording of Details that is reasonable as a basis for recording Details. For the avoidance of doubt, Details shall not include any reminder or sample drop or discussions at conventions or other meetings not specifically sponsored by a Party for a Product.

  • “Develop,” “Development,” “Developed” or “Developing” means preclinical and clinical drug or biological development activities, including Research activities, product design, synthesis, test method development, toxicology, formulation, quality assurance/quality control development, statistical analysis, preclinical and non-clinical studies and Clinical Trials (including post-approval clinical studies), including making Regulatory Submissions and filing for, obtaining and maintaining Regulatory Approvals and other registrations, as well as any and all regulatory activities related to any of the foregoing and activities that are otherwise reasonably necessary or useful in anticipation of or in preparation of Commercialization of a product (including any activities related to any of the foregoing for development of a companion diagnostic product used in connection with such product), but excluding activities directed to Manufacturing.

  • “Developing Party” has the meaning set forth in Section 4.4(c)(iii).

  • “Development Costs” means all FTE Costs and Out-of-Pocket Expenses incurred by or on behalf of a Partnership Party that are reasonably identified or allocable to such Partnership Party’s Development activities with respect to Products in the Territory under the Development Plan

  • and Budget and Manufacturing activities in support of such Development activities from and after the Effective Date and during the Term pursuant to this Agreement, including:

  • all FTE Costs and Out-of-Pocket Expenses incurred by a Partnership Party in conducting activities specified in the Development Plan and Budget;

  • the costs and expenses of non-clinical and clinical supplies for Development activities set forth in the Development Plan and Budget, including: [***]; and

  • regulatory activities with respect to Products in the Territory (including in connection with Clinical Trials (including any Phase 4 Clinical Trial that is required by the applicable Regulatory Authority) or preparation, submission and review of Regulatory Submissions with any Governmental Authority in the Territory) conducted in accordance with the Development Plan and Budget.

Development Costs shall exclude [***]. For clarity, [***] shall not be considered a Development Cost unless [***].

  • “Development Plan and Budget” has the meaning set forth in Section 4.2.

  • “Directed to” means, with respect to a molecule and a target, that such molecule binds to such target and inhibits, degrades or otherwise modulates such target. For clarity, the foregoing shall not include [***].

  • “Disclosing Party” has the meaning set forth in Section 9.1.

  • “Discretionary Commercialization or Medical Affairs Activities” has the meaning set forth in Section 5.2.

  • “Discretionary Development Activities” has the meaning set forth in Section 4.2.

  • “Dispute” has the meaning set forth in Section 14.1.

  • “Distribution Costs” means with respect to a Product and a given Calendar Quarter, the costs incurred by a Partnership Party or its Affiliates (on behalf of such Partnership Party), or for its or their account, in connection with the freight, transportation, insurance, handling, packaging and distribution of such Product in the U.S. Territory in accordance with the U.S. Territory Commercialization Plan and Budget.

  • “Distributor” means, with respect to any country in the Territory, any entity that (a) is not a Sublicensee or Affiliate of KKC, (b) purchases Products from KKC or its Affiliates or Sublicensees for such country, (c) assumes responsibility from KKC or its Affiliate or Sublicensee for all or a portion of the Commercialization of Products in such country, and (d) sells Products in such country without providing any consideration to KKC or its Affiliate or Sublicensee on account of such sales.

  • “Effective Date” has the meaning set forth in the preamble in this Agreement.

  • “EMA” means the European Medicines Agency or any successor agency in the European Union.

  • “Embargoed Country” has the meaning set forth in Section 10.6(b).

  • “Enrollment Target” means, with respect to a Clinical Trial, the target number (or target range) of patients to be enrolled for such Clinical Trial, as may be specified in the Development Plan and Budget or Ex-U.S. Territory Development Plan, as applicable.

  • “European Union” means the economic, scientific and political organization of member states known as the European Union, as its membership may be altered from time to time, and any successor thereto.

  • “Ex-U.S. Commercial Milestone Event” has the meaning set forth in Section 8.6(a).

  • “Ex-U.S. Commercial Milestone Payment” has the meaning set forth in Section 8.6(a).

  • “Ex-U.S. Development Milestone Event” has the meaning set forth in Section 8.3(a).

  • “Ex-U.S. Development Milestone Payment” has the meaning set forth in Section 8.3(a).

  • “Ex-U.S. Discretionary Development Activities” has the meaning set forth in Section 4.3.

  • “Ex-U.S. Solid Tumor Development Milestone Event” has the meaning set forth in Section 8.5(a).

  • “Ex-U.S. Solid Tumor Development Milestone Payment” has the meaning set forth in Section 8.5(a).

  • “Ex-U.S. Territory” means all countries and territories in the Territory other than the U.S. Territory.

  • “Ex-U.S. Territory Commercialization Plan” means the written plan for the Commercialization of Products in the Ex-U.S. Territory, as updated in accordance with this Agreement.

  • “Ex-U.S. Territory Development Costs” means all costs for the Development of Products in the Ex-U.S. Territory (including under the Ex-U.S. Territory Development Plan), excluding, for clarity, any Shared Development Costs.

  • “Ex-U.S. Territory Development Plan” has the meaning set forth in Section 4.3.

  • “Ex-U.S. Territory Field Expansion Option” has the meaning set forth in Section 2.8(a).

  • “Ex-U.S. Territory Term” means the period commencing on the Effective Date and continuing until the expiration of the last-to-expire Royalty Term for all Products in all countries in the Ex-U.S. Territory.

  • “Excluded Development Activities” means activities undertaken by Kura or KKUS in accordance with the initial Development Plan and Budget that are planned to be conducted during the period from the Effective Date until the end of Calendar Year 2028 in substantially the same

  • scope and at substantially the same cost as those specifically set forth in the initial Development Plan and Budget (regardless of when such activities are actually conducted).

  • “Executive Officers” has the meaning set forth in Section 3.2(c).

  • “Existing Field” has the meaning set forth in Section 1.105.

  • “Existing Upstream Agreement” means any agreement between Kura or any of its Affiliates, on the one hand, and a Third Party licensor, on the other hand, entered into prior to the Effective Date under which Kura or any of its Affiliates Controls or purports to Control any Patents or Know-How constituting Kura Patents or Kura Know-How, together with any amendments thereto. All Existing Upstream Agreements in existence as of the Effective Date are set forth on Schedule 1.98.

  • “Expanded Indication Trial” has the meaning set forth in Section 4.4(c). For clarity, Expanded Indication Trial shall exclude any (a) Mandatory Development Activities, (b) Combination Clinical Trial, or (c) Marketing Trial.

  • “Expiration Date” has the meaning set forth in Section 13.1(a).

  • “Exploit” or “Exploitation” means to Develop, have Developed, use, Manufacture, have Manufactured, sell, have sold, offer for sale, Commercialize, import, export, register, and otherwise exploit a Product.

  • “Export Control Laws” means (a) all applicable U.S. laws and regulations relating to export controls, trade sanctions, and embargoes, including the Arms Export Controls Act (22 U.S.C. Ch. 39), the International Emergency Economic Powers Act (50 U.S.C. §§ 1701 et seq.), the Trading With the Enemy Act (50 U.S.C. app. §§ 1 et seq.), the Export Administration Act of 1979 (50 U.S.C. app. §§ 2401 et seq.), International Boycott Provisions of Section 999 of the U.S. Internal Revenue Code of 1986, and all rules, regulations and executive orders relating to any of the foregoing, including but not limited to the International Traffic in Arms Regulations (22 C.F.R. §§ 120 et seq.), the Export Administration Regulations (15 C.F.R. §§ 730 et. seq.), and the regulations administered by the Office of Foreign Assets Controls of the United States Department of the Treasury; and (b) all export controls imposed on any Product by any country or organization or nations within the jurisdiction of which a Party operates or does business.

  • “Extensions” has the meaning set forth in Section 12.9.

  • “FDA” means the United States Food and Drug Administration or any successor agency in the U.S. Territory.

  • “Field” means (a) as of the Effective Date, all prophylactic, diagnostic and therapeutic uses for any cancer in humans specifically associated with (i) blood-forming tissue, such as the bone marrow, or (ii) the cells of the immune system, including, without limitation, leukemia, lymphoma, multiple myeloma and myelodysplastic syndrome, and for clarity, excluding any prophylactic, diagnostic or therapeutic uses for solid tumors (the foregoing clause (a), collectively, the “Existing Field”), and (b) solely if KKC exercises the Field Expansion Option, following the Field Expansion Effective Date, all prophylactic, diagnostic and therapeutic uses for any cancer in humans, including solid tumors in humans.

  • “Field Expansion Effective Date” means later to occur of (a) the date upon which Kura has received KKC’s written notice of exercise of the Field Expansion Option and (b) the date of KKC’s payment of the Field Expansion Option Exercise Payment pursuant to Section 2.8(b).

  • “Field Expansion Option” has the meaning set forth in Section 2.8(a).

  • “Field Expansion Option Exercise Payment” has the meaning set forth in Section 2.8(b).

  • “Field Expansion Option Period” has the meaning set forth in Section 2.8(b).

  • “First Commercial Sale” means, with respect to any Product and country in the Territory, the first sale of such Product to a Third Party in such country by any Party or its Affiliate or any Sublicensee for end use or consumption in such country following Regulatory Approval. Sales prior to receipt of marketing and pricing approvals, such as so-called “treatment IND sales,” “named patient sales” and “compassionate use sales”, to the extent such Product is provided without charge or for an amount no greater than the Fully Burdened Manufacturing Cost for such Product are not a First Commercial Sale in that region.

  • “FLT3” means the protein FMS-like tyrosine kinase 3 (FLT-3), also known as cluster of differentiation antigen 135 (CD135) or receptor-type tyrosine-protein kinase FLT3.

  • “FLT3 Combination Indication” means the use of the Product together with a FLT3 inhibitor as a Combination Product or combination therapy for the treatment of patients with newly-diagnosed AML.

  • “Foundation” means [***].

  • “FTE” means the equivalent of the work of a full-time individual dedicated to Development, Manufacturing, Commercialization or Medical Affairs activities with respect to Products pursuant to this Agreement for a [***] month period based on [***] hours per Calendar Year. In the case that any personnel of a Party or its Affiliate works partially on Development, Manufacture, Commercialization or Medical Affairs activities with respect to Products and partially on other activities in a given Calendar Year, then the full-time equivalent to be attributed to such individual’s work hereunder shall be equal to the percentage of such individual’s total work time in such Calendar Year that such individual spent working on Development, Manufacture, Commercialization or Medical Affairs activities with respect to Products. FTE efforts shall not include the work of general corporate personnel. Each Party shall track FTEs using its standard practice and normal systems and methodologies.

  • “FTE Costs” means, with respect to a Party for any period, the applicable FTE Rate multiplied by the applicable number of FTEs of such Party or its Affiliate performing Development, regulatory, Manufacturing, Medical Affairs or Commercialization activities with respect to Products in accordance with the applicable Development Plan and Budget or U.S. Territory Commercialization Plan and Budget.

  • “FTE Rate” means, unless otherwise agreed by the Parties, (a) with respect to Kura, a rate of US$[***] per FTE per Calendar Year, to be pro-rated on an hourly basis of US$[***] per FTE per hour, or (b) with respect to KKUS and KKJP, a rate of US$[***] per FTE per Calendar Year, to be pro-rated on an hourly basis of US$[***] per FTE per hour, in each case (a) and (b), subject to annual adjustment beginning on [***], by an amount equal to [***].

  • [***] has the meaning set forth in Section 2.4(b).

  • [***] has the meaning set forth in Section 2.4(c).

  • [***] has the meaning set forth in Section 2.4(c).

  • “Fully Burdened Manufacturing Costs” means the cost of Manufacturing Products (including the Compound contained therein). Fully Burdened Manufacturing Costs for Products that are Manufactured directly by a Party or its Affiliate shall be a “standard cost” per unit (calculated annually), comprised of the following elements calculated in accordance with Accounting Standards: [***].

  • “Gastrointestinal Stromal Tumor Indication” means the use of the Product together with imatinib or any other KIT inhibitor(s) as a Combination Product or combination therapy for the treatment of adult patients with KIT-mutant advanced gastrointestinal stromal tumors.

  • “GCP” means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of Clinical Trials, including, as applicable (a) as set forth in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki as last amended at the 64th World Medical Association in October 2013 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 54 (Financial Disclosure by Clinical Investigators), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws in the region in the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.

  • “GDPR” means, as and where applicable to the Processing concerned: (a) the General Data Protection Regulation (Regulation (EU) 2016/679); and/or (b) the EU GDPR as it forms part of UK law by virtue of section 3 of the European Union (Withdrawal) Act 2018 (as amended), including, in each case of (a) and (b), any applicable national implementing or supplementary legislation (e.g., the UK Data Protection Act 2018), and any successor, amendment or re-enactment, to or of the foregoing. References to “Articles” and “Chapters” of, and other relevant defined terms in, the GDPR shall be construed accordingly.

  • “Generic Competition” means, with respect to a Product in a country in the Ex-U.S. Territory, after the first sale of a Generic Product in a country in the Ex-U.S. Territory, the first Calendar Quarter in which the Net Sales of such Product in such country is [***].

  • “Generic Product” means, with respect to a Product in a country in the Ex-U.S. Territory, any pharmaceutical product that (a)(i) is sold by a Third Party that has not obtained rights to, and did not purchase, such product or its active pharmaceutical ingredients from KKC or any of its Affiliates or Sublicensees, under a marketing authorization granted by a Regulatory Authority to such Third Party, and (ii) contains the same Compound as an active pharmaceutical ingredient as such Product, and (b) is approved in reliance on the prior approval of such Product as determined by the applicable Regulatory Authority in such country.

  • “Global Branding Strategy” has the meaning set forth in Section 3.4(b)(iv).

  • “Global Clinical Supply Agreement” has the meaning set forth in Section 7.1(c).

  • “Global Clinical Trial” means a Clinical Trial designed to obtain Regulatory Approvals for a Product in the U.S. Territory and the Ex-U.S. Territory, and conducted in multiple medical institutions in multiple countries, regions or territories and conducted as part of one (1) unified Clinical Trial or separately but concurrently in accordance with a common Clinical Trial protocol.

  • “Global Pricing Strategy” has the meaning set forth in Section 3.4(b)(iii).

  • “GLP” means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, or the equivalent Applicable Laws in the region in the Ex-U.S. Territory, each as may be amended and applicable from time to time.

  • “Governmental Authority” means any court, commission, authority, agency, administration, department, ministry, official or other instrumentality of, or being vested with public authority under any law of, any country, region, state or local authority or any political subdivision thereof, or any association of countries.

  • “Handover Deficiencies” has the meaning set forth in Section 2.5(a).

  • “Hatch-Waxman Act” means rights conferred in the U.S. under the Drug Price Competition and Patent Term Restoration Act, 21 U.S.C. § 355, as amended (or any successor statute or regulation).

  • “ICC Rules” has the meaning set forth in Section 14.4(a).

  • “Imatinib Combination Product” means a Combination Product or combination therapy consisting of (a) the Compound and (b) that certain tyrosine kinase inhibitor known as imatinib or any salt, polymorph, hydrate, semihydrate or other pharmaceutically acceptable form thereof, for example, imatinib mesylate.

  • “IND” means an investigational new drug application or equivalent application filed with the applicable Regulatory Authority, which application is required to commence Clinical Trials in the applicable jurisdiction.

  • “Indemnifying Party” has the meaning set forth in Section 11.3.

  • “Indemnitee” has the meaning set forth in Section 11.3.

  • “Indirect Tax” has the meaning set forth in Section 8.12(a).

  • “Initiation” means, with respect to a Clinical Trial, the first dosing of the first human subject in such Clinical Trial.

  • “Intended Tax Treatment” has the meaning set forth in Section 8.13(b).

  • “Invention” means any process, method, composition of matter, article of manufacture, discovery or finding, patentable or otherwise, that is invented, discovered or generated as a result of a Party (or the Parties jointly) exercising its (their) rights or carrying out its (their) obligations under this Agreement, including all rights, title and interest in and to the intellectual property rights therein.

  • “Joint Commercialization Committee” or “JCC” has the meaning set forth in Section 3.4(a).

  • “Joint Controller(s)” means two or more Controllers that jointly determine the purposes and means of Processing Personal Data.

  • “Joint Development Committee” or “JDC” has the meaning set forth in Section 3.3(a).

  • “Joint Invention” has the meaning set forth in Section 12.1(b).

  • “Joint Manufacturing Committee” or “JMC” has the meaning set forth in Section 3.5.

  • “Joint Patent” has the meaning set forth in Section 12.1(b).

  • “Joint Steering Committee” or “JSC” has the meaning set forth in Section 3.2.

  • “KIT” means the KIT gene encoding a receptor tyrosine kinase protein (NCBI Entrez Gene: 3815) or the encoded protein, as appropriate for the context.

  • “KKC” has the meaning set forth in the preamble of this Agreement (or its successor or assign).

  • “KKC Audit” has the meaning set forth in Section 7.1(h).

  • “KKC CMO” has the meaning set forth in Section 7.3.

  • “KKC Indemnitee(s)” has the meaning set forth in Section 11.2.

  • “KKC Menin Inhibitor Invention” means Inventions owned by KKC or its Affiliates that [***] any small molecule inhibitor that is Directed to the interaction of the protein menin and the protein expressed by KMT2A (such small molecule inhibitor, a “Menin Inhibitor”).

  • “KKC Patents” means any Patents within the KKC Technology.

  • “KKC Product Marks” has the meaning set forth in Section 12.11(b).

  • “KKC Reversion Technology” means any Patents and Know-How Controlled by KKC or its Affiliates [***] that [***].

  • “KKC Sole Inventions” has the meaning set forth in Section 12.1(b).

  • “KKC Technology” means any and all Know-How and Patents Controlled by KKC or its Affiliates as of the Effective Date or during the Term, including KKC’s joint ownership interest in any Know-How within the Joint Inventions or in any Joint Patents, that (a) are generated

  • or developed by or on behalf of KKC or its Affiliates or Sublicensees pursuant to this Agreement or (b) Cover (with respect to Patents), or is necessary or reasonably useful for (with respect to Know-How), the Development, Manufacture, registration, use or Commercialization of the Compounds and Products in the Field in the Territory.

  • “KKJP Upfront Payment” has the meaning set forth in Section 8.1(b).

  • “KKUS Expanded Indication Trial Data” has the meaning set forth in Section 4.4(c)(iv).

  • “KKUS Upfront Payment” has the meaning set forth in Section 8.1(a).

  • “KMT2A” means the KMT2A gene encoding Lysine K-specific Methyl Transferase 2A (NCBI Entrez Gene: 4297) or the encoded protein, as appropriate for the context.

  • “Know-How” means any proprietary scientific or technical information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including databases, safety information, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, medicinal chemistry, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, and manufacturing process and development information, results and data.

  • “KOMET-001 Trial” means the Clinical Trial for a Product for the Relapsed or Refractory AML Mono Indication titled “KOMET-001” as further described in the Development Plan and Budget.

  • “KOMET-017 Trial” means the Clinical Trial for a Product for the 7+3 Indication and/or Ven/Aza Indication titled “KOMET-017” as further described in the Development Plan and Budget.

  • “Kura” has the meaning set forth in the preamble of this Agreement (or its successor or assign).

  • “Kura Ex-U.S. Technology” means any and all Patents and Know-How within Kura Technology that are necessary or reasonably useful for the Development, use or Commercialization of the Compound or Products in the Field in the Ex-U.S. Territory.

  • “Kura Expanded Indication Trial Data” has the meaning set forth in Section 4.4(c)(iv).

  • “Kura Indemnitee(s)” has the meaning set forth in Section 11.1.

  • “Kura Know-How” means any and all Know-How Controlled by Kura or its Affiliates as of the Effective Date or during the Term, including Kura’s joint ownership interest in any Know-How within the Joint Inventions, that is necessary or reasonably useful for (a) the Development, use or Commercialization of the Products in the Field in the Territory or (b) the Manufacture of the Products in the Field in the Territory.

  • “Kura Manufacturing Technology” means any and all Patents and Know-How within Kura Technology that Cover (with respect to Patents), or are necessary or reasonably useful for (with respect to Know-How), the Manufacture of the Products in the Field in the Territory.

  • “Kura Non-Product Patents” means any Kura Patent solely owned by Kura that is not a Kura Product Patent. For clarity, Kura Non-Product Patents excludes the Ziftomenib Composition Patents and the MSK Patents.

  • “Kura Patents” means (a) any and all Patents in the Territory Controlled by Kura or its Affiliates as of the Effective Date or during the Term, including Kura’s joint ownership interest in any Joint Patents in the Territory, that Cover the Development, use or Commercialization of the Products in the Field in the Territory and (b) any and all Patents Controlled by Kura or its Affiliates as of the Effective Date or during the Term, including Kura’s joint ownership interest in any Joint Patents, that Cover the Manufacture of the Products in the Field in the Territory, including the patents set forth in Schedule 1.175. For clarity, Kura Patents shall include the Ziftomenib Composition Patents, but shall exclude [***].

  • “Kura Product Marks” has the meaning set forth in Section 12.11(a).

  • “Kura Product Patents” means any Kura Patent solely owned by Kura that claims (a) the composition of matter of any Compound, or (b) any method of use of any Compound or Product for an indication in the Field. For clarity, Kura Product Patents excludes the Ziftomenib Composition Patents and the MSK Patents.

  • “Kura Technology” means the Kura Know-How and Kura Patents.

  • “Kura U.S. Technology” means any and all Patents and Know-How within Kura Technology that are necessary or reasonably useful for the Development, use or Commercialization of the Compound or Products in the Field in the U.S. Territory.

  • “Licensed Component” has the meaning set forth in Section 1.45.

  • “LLS” means the Leukemia and Lymphoma Society.

  • “Local Clinical Trial” means a Clinical Trial other than the Global Clinical Trials.

  • “Losses” has the meaning set forth in Section 11.1.

  • “Major Filing Delay” means a delay to the filing of any Regulatory Approval Application [***] as compared to the timelines set forth in the initial Development Plan and Budget, [***].

  • “Mandatory Development Activities” has the meaning set forth in Section 4.4(b).

  • “Manufacture” or “Manufacturing” or “Manufactured” means all operations involved in the manufacturing, filling and finishing, quality control testing (including in-process, release and stability testing, if applicable), storage, releasing, packaging and labeling.

  • “Manufacturing Technology Transfer” has the meaning set forth in Section 7.3.

  • “Marketing Expenses” means, with respect to a Product and a given Calendar Quarter, the costs and expenses (not otherwise included in Advertising and Promotion Expenses or in Selling and Promotion Expenses, and excluding Allocable Overhead Costs or any other overhead

  • costs) incurred by a Partnership Party or its Affiliates (on behalf of such Partnership Party) in accordance with the U.S. Territory Commercialization Plan and Budget in connection with the marketing and support of such Product in the U.S. Territory, including FTE Costs and allocable costs associated with a Party’s or its Affiliate’s or Sublicensee’s marketing operations, contracting operations, field reimbursement support and patient services hub, costs and expenses of strategic planning activities, market research, and market access but excluding [***].

  • “Marketing Trial” means any Phase 4 Clinical Trial, Non-Interventional Studies or other clinical trials or studies of a Product with the main objective to collect data to increase product knowledge or for marketing and market access purposes, including pricing studies or investigator-initiated trials, in each case excluding Mandatory Development Activities.

  • “Material Adverse Regulatory Event” means an action taken by a Regulatory Authority, the effect of such would [***] Kura’s ability to obtain Regulatory Approvals (e.g., [***]), other than [***].

  • “Medical Affairs” means interactions with medical or healthcare professionals who utilize or could utilize a pharmaceutical product or who conduct research or could conduct research related to a pharmaceutical product, including the exchange of medical and scientific information and the response to their inquiries or complaints. Medical Affairs includes (but is not limited to) non-exclusive activities and departments such as pharmacovigilance, Marketing Trials, medical education, Health Economics and Outcomes Research (HEOR), conducting or participating in symposia and advisory boards, reviewing, approving and funding educational grants and fellowships, determination of and communication of benefit/risk or pharmaceutical products, field based medical science liaisons, clinical trial management of studies conducted out of the medical affairs department, medical doctors in the field that conduct medical affairs activities as described herein (separate from medical science liaisons), publications planning group, medical communications group and field medical education group. For purposes of this Agreement, including preparation of plans and budgets, all Medical Affairs activities in the U.S. Territory will be included the U.S. Territory Commercialization Plan and Budget. For the avoidance of doubt, Medical Affairs does not include any activities involving the marketing, promotion or sale of any Product.

  • “Medical Affairs Costs” means, with respect to a Product and a given Calendar Quarter, all costs (excluding Allocable Overhead Costs or any other overhead costs) incurred by a Party or its Affiliates in accordance with the U.S. Territory Commercialization Plan and Budget in connection with Medical Affairs activities with respect to such Product in the U.S. Territory, including FTE Costs and allocable costs associated with [***].

  • “Menin Inhibitor” has the meaning set forth in Section 1.155.

  • “MHLW” means the Ministry of Health, Labor and Welfare of Japan, or any successor Governmental Authority that is responsible for approving the sale of pharmaceuticals in Japan.

  • “Michigan” means the Regents of the University of Michigan, and where applicable, includes its Regents, officers, employees, students and agents.

  • “Michigan Indemnitee(s)” has the meaning set forth in Section 11.1.

  • “Michigan License” means that certain Patent License Agreement by and between Kura and Michigan dated December 22, 2014, including all subsequent amendments thereto.

  • “Milestone Events” means U.S. Development Milestone Events, Ex-U.S. Development Milestone Events and Ex-U.S. Commercial Milestone Events.

  • “Milestone Payments” means U.S. Development Milestone Payments, Ex-U.S. Development Milestone Payments and Ex-U.S. Commercial Milestone Payments.

  • “MSK” means Memorial Sloan Kettering Cancer Center.

  • “MSK Indemnitee(s)” has the meaning set forth in Section 11.1.

  • “MSK License” means that certain Non-Exclusive License Agreement by and between Kura and MSK dated [***], including all subsequent amendments thereto.

  • “MSK Patents” means any and all Patents licensed to Kura by MSK under the MSK License, to the extent such Patents are within the definition of Kura Patents hereunder.

  • “Net Sales” means, with respect to any Product, the gross amount invoiced on sales of such Product in the Field in the U.S. Territory by a Partnership Party or any of its Affiliates (on behalf of such Partnership Party) or, in the case of Products sold in the Ex-U.S. Territory only, by KKJP or any of its Affiliates or Sublicensees, to a Third Party that is not a Sublicensee, less (without duplication) for the following deductions which are actually incurred, allowed, paid, accrued or specifically allocated to such gross sales of such Product:

  • [***];

  • [***];

  • [***];

  • [***]; and

  • [***].

Where a Partnership Party, KKC, its Affiliate or Sublicensee receives any consideration other than cash for such transactions, the fair market cash value for such consideration, equal to the established average price charged in cash transactions in such country or as otherwise agreed upon by the Parties hereto, shall be included in Net Sales.

Each of the amounts set forth above shall be determined from the books and records of a Partnership Party, KKC, its Affiliate or Sublicensee, maintained in accordance with Accounting Standards or in the case of Sublicensees, such similar accounting principles, consistently applied, and may include calculations using accrual accounting where applicable. Any amounts that are deducted from Net Sales pursuant to one subsection may not be deducted pursuant to another subsection (i.e., a deduction may only be taken once).

The transfer of a Product to an Affiliate, Sublicensee, or other Third Party (1) in connection with the research, Development or testing of a Product (including the conduct of Clinical Trials), (2) for purposes of distribution as promotional samples, (3) for indigent or similar

public support or compassionate use programs, or (4) by and between a Partnership Party or KKJP, as applicable, and its Affiliates or Sublicensees shall not, in any case, be considered a Net Sale of a Product under this Agreement. Subject to the foregoing, any amounts received by a Partnership Party, KKJP, its Affiliates or Sublicensees for Products prior to or after Regulatory Approval in the Territory shall be Net Sales. For clarity, Net Sales will not include sales of a Product in the U.S. Territory by a Sublicensee.

Net Sales shall also include and be deemed to have been made with respect to any Products used by a Partnership Party or KKJP, as applicable, or any Affiliate, for its own commercial purposes, or transferred to any Third Party for less than what the transferee is then charging in normal arms-length sales transactions; and Net Sales in all such cases shall be deemed to have been made at the prices therefor at which such Products are then being sold to the customers of such user or transferor (or of a Partnership Party or KKJP, if an Affiliate is a user but not a seller) in arms-length sales transactions. For clarity, in the event the Product is sold in an arms-length transaction to a governmental agency, a group purchase entity or any other entity having the bargaining power to negotiate the purchase price below normal retail price in transactions of lesser volume, Net Sales shall be calculated based on the actual price negotiated and agreed to for such agency or entity and not be based on the price charged in other arms-length sales transactions.

To the extent that a Partnership Party, KKJP or any of its Affiliates, or Sublicensees, provides to the purchasing Third Party discounts or allowances that are applicable to purchases of the Products and one or more other products (such as in a “portfolio contract” arrangement), such discounts and allowances shall be structured in compliance with Applicable Laws, allocated between the Products (for purposes of the deductions used in calculating Net Sales as above) and such other products in an equitable and commercially reasonable manner, in proportion to their pre-discounted sales price, which does not unfairly or inappropriately bias the level of discounting against the Products (as compared to the other products), provided that any such discount for any Product shall not exceed [***] percent ([***]%).

If a Partnership Party, KKJP or any of its Affiliates or Sublicensees sells a Product as a Licensed Component of a Combination Product in the Territory in any Calendar Quarter, then the following provisions shall apply:

  • Net Sales shall be calculated by [***].

  • For purposes of calculating the average Net Sales per unit sold of a Licensed Component and Other Component(s) of a Combination Product, any of the deductions described herein that apply to such Combination Product shall be allocated [***].

  • In the event that, on a country-by-country basis in the Territory, no separate sales of the Licensed Component or any Other Component(s) included in a Combination Product are made by a Partnership Party or KKJP, as applicable, or its Affiliates or Sublicensees during a Calendar Quarter in which such Combination Product is sold, the average Net Sales per unit sold in the above described equation shall be replaced with [***].

  • “Next-Gen Compound” means any Menin Inhibitor, other than a Compound, that is Controlled by Kura or its Affiliates as of the Effective Date or during the Term.

  • “Non-Interventional Studies” means studies and activities to gain more knowledge about any Compound or Product and the potential indications for which such Compound

  • or Product may be efficacious, including epidemiological studies, natural history studies, real world evidence studies based on registries or databases, predictive modeling or pharmacoeconomic studies, burden of illness studies, and post-marketing surveillance studies (but not Phase 4 Clinical Trials).

  • “NPM1” means the NPM1 gene encoding the nucleophosmin protein (NCBI Entrez Gene: 4869) or the encoded protein, as appropriate for the context.

  • “Opt-In Right” has the meaning set forth in Section 4.4(c)(v).

  • “Other Component” has the meaning set forth in Section 1.45.

  • “Out-of-Pocket Expenses” means, respect to the activities under this Agreement, direct costs and expenses paid or payable by the relevant Party or its Affiliates or Sublicensees, to Third Parties (other than employees of such Party or its Affiliates or Sublicensees) that (a) are specifically identifiable and incurred (i) in the course of activities conducted under the Development Plan and Budget or the U.S. Territory Commercialization Plan and Budget or in connection with filings to any Regulatory Authority relating to the Compound or Products in the Field, or (ii) for Patent Prosecution, Extension or enforcement of Kura Patents (including Joint Patents included therein) in the Territory, and (b) have been recorded in accordance with Accounting Standards, and for the avoidance of doubt, do not include travel expenses or capital expenditures.

  • “Partnership Party” and “Partnership Parties” means Kura on the one hand, KKUS on the other hand and Kura and KKUS together as the context requires.

  • “Party” or “Parties” has the meaning set forth in the preamble to this Agreement.

  • “Patent” means (a) any national, regional or international patent or patent application, including any provisional patent application, (b) any patent application claiming priority from such patent application or provisional patent application, including any division, continuation, continuation-in-part, or addition, (c) any patent that has issued or in the future issues from any of the foregoing patent applications, including any utility, invention, or design patent or certificate of invention, and (d) any re-issue, renewal, extension, substitution, re-examination or restoration, registration or revalidation, or supplementary protection certificate or equivalents to any of the foregoing.

  • “Patent Costs” has the meaning set forth in Section 12.3(a)(i).

  • “Patent Prosecution” means, with regard to a particular Patent, the preparation, filing, prosecution and maintenance (including paying maintenance fees and annuities) of such Patent.

  • “Permitted Solid Tumor Indication” means (a) the Gastrointestinal Stromal Tumor Indication and (b) any other Solid Tumor Indication for which [***].

  • “Person” means any individual, sole proprietorship, corporation, joint venture, limited liability company, partnership, limited partnership, limited liability partnership, trust or any other private, public or governmental entity.

  • “Personal Data” means any data that constitutes “personal information”, “personal data” or similar term as defined and governed by applicable Data Protection Laws. For clarity, Personal Data does not include anonymized or aggregated data.

  • “Pharmacovigilance Agreement” has the meaning set forth in Section 4.6.

  • “Phase 1 Clinical Trial” means a Clinical Trial of a Product that is described as a phase 1 clinical trial in its protocol, or that would otherwise satisfy the requirements of 21 C.F.R. § 312.21(a), as amended from time to time, or the foreign equivalent thereof in any applicable jurisdiction other than the United States.

  • “Phase 1/2 Clinical Trial” means a Clinical Trial that combines both a Phase 1 Clinical Trial and a Phase 2 Clinical Trial into a single protocol.

  • “Phase 2 Clinical Trial” means a Clinical Trial of a Product that is described as a phase 2 clinical trial in its protocol, or that would otherwise satisfy the requirements of 21 C.F.R. § 312.21(b), as amended from time to time, or the foreign equivalent thereof in any applicable jurisdiction other than the United States.

  • “Phase 3 Clinical Trial” means a Clinical Trial of a Product that is described as a phase 3 clinical trial in its protocol, or that would otherwise satisfy the requirements of 21 C.F.R. § 312.21(c), as amended from time to time, or the foreign equivalent thereof in any applicable jurisdiction other than the United States.

  • “Phase 4 Clinical Trial” means an interventional Clinical Trial of a Product that is commenced after receipt of Regulatory Approval in the country where such Clinical Trial is conducted and does not lead to a new, labeled indication for the Product.

  • “Pivotal Clinical Trial” means a Clinical Trial of a Product, the results of which, if successful, could be sufficient to support the filing for Regulatory Approval of such Product, including any Phase 3 Clinical Trials or any Clinical Trial identified as a pivotal or registrational Clinical Trial in the Development Plan and Budget or the Ex-U.S. Territory Development Plan, provided that Pivotal Clinical Trial will also include Phase 2 Clinical Trials or Phase 1/2 Clinical Trials if any of the conditions of this Section 1.225 are met. If a Clinical Trial does not constitute a Pivotal Clinical Trial at the time of the dosing of the first human subject in such Clinical Trial, but (a) the protocol is later amended so that it constitutes a Pivotal Clinical Trial, (b) it is later acknowledged by the applicable Regulatory Authority pursuant to a statement in guidance, correspondence to the sponsor, or meeting minutes issued by the relevant Regulatory Authority, a Special Protocol Assessment with the FDA or an analogous agreement with another relevant Regulatory Authority, or otherwise, that such Clinical Trial is sufficient to form the primary basis of an efficacy claim in a Regulatory Approval Application, (c) a Party (or any of its Affiliates or (sub)licensees) submits a Regulatory Approval Application containing data from such Clinical Trial to the applicable Regulatory Authority or (d) it is later determined by the applicable Regulatory Authority that such Clinical Trial is sufficient to form the primary basis of an efficacy claim in a Regulatory Approval Application (including by approval of such a Regulatory Approval Application), then, for purposes of this Agreement, the “Initiation” of such Clinical Trial shall be deemed to have occurred on the date of (a), (b), (c) or (d), whichever occurs first.

  • “POC Data Package” has the meaning set forth in Section 2.8(b).

  • “Post-Marketing Commitment” means any Clinical Trial or Development activity, including Phase 4 Clinical Trials, which a Regulatory Authority requires for a Product following Regulatory Approval by such Regulatory Authority.

  • “Post-Transplant Maintenance Indication” means the use of the Product as a maintenance treatment following allogeneic hematopoietic stem cell transplant for patients with AML.

  • “Prime Rate” means for any day a per annum rate of interest equal to the “prime rate,” as published in the “Money Rates” column of The Wall Street Journal, from time to time, or if for any reason such rate is no longer available, a rate equivalent to the base rate on corporate loans posted by at least [***] ([***]%) of the ten largest U.S. banks.

  • “Process” (and any inflection thereof) means any operation or set of operations performed on data (including, without limitation, Personal Data), whether or not by automatic means, such as collection, recording, organization, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, blocking, erasure or destruction.

  • “Product” means any pharmaceutical product containing the Compound, whether or not as the sole active ingredient, in any dosage, form or formulation ready for dispensing to or consumption by an end-user, in each case: (a) as agreed to by the Parties under the Development Plan and Budget or (b) as approved for or that is the subject of an Expanded Indication Trial, Combination Clinical Trial or Marketing Trial.

  • “Product Infringement” has the meaning set forth in Section 12.4(a).

  • “Product Liability Costs” means, with respect to a Product and a given Calendar Quarter, (a) costs directly incurred by a Partnership Party or its Affiliates (on behalf of such Partnership Party) in connection with Third Party product liability or intellectual property infringement claims or actions, not including the costs of internal personnel incurred in the defense of any such claim, to the extent resulting or arising from the Development, Manufacturing or Commercialization of such Product in the Field for the U.S. Territory under this Agreement, but excluding any such costs incurred with respect to a Claim to the extent such Partnership Party is obligated to provide indemnification under ARTICLE 11 of this Agreement, and (b) a reasonable allocation of the costs of product liability insurance premiums for policies covering the Development, Manufacture or Commercialization of such Product in the Field in the U.S. Territory.

  • “Product Mark” means (a) a Kura Product Mark; or (b) a KKC Product Mark.

  • “Profit-or-Loss” means, with respect to a Product and a given Calendar Quarter:

  • the Shared Commercial Revenue for such Product during such Calendar Quarter, minus;

  • the Shared Commercial Costs for such Product during such Calendar Quarter;

in each case, (y) to the extent such deductions have not already or otherwise been deducted, and (z) determined from the books and records of the applicable Partnership Party or its Affiliates or Sublicensees in accordance with Accounting Standards. For purposes of clarity, it is understood that (i) Shared Commercial Costs shall not include any Shared Development Costs, (ii) there shall be no double-counting of expenses within the definition of Profit-or-Loss and (iii) the Profit-or-Loss shall be calculated and payable in accordance with Section 8.8 even

if there are no Net Sales and prior to the First Commercial Sale in the U.S. Territory. For clarity, it is the intent of the Parties that costs and headcount for any Commercialization activities with respect to a Product that have or may have benefit in the U.S. Territory and outside the U.S. Territory shall be appropriately allocated by agreement of the JCC between costs allocable to the U.S. Territory, which shall be included in Shared Commercial Costs, and costs not allocable to the U.S. Territory, which shall not be included in Shared Commercial Costs. If the Profit-or-Loss is a positive number, it will be a “Profit” and if it is a negative number, it will be a “Loss”.

  • “Profit-or-Loss Statement” has the meaning set forth in Section 8.8(b).

  • “Prohibited Parties” has the meaning set forth in Section 10.6(b).

  • “Proposed Resolution” has the meaning set forth in Schedule 1.204.

  • “Public Official” has the meaning set forth in Section 10.5(b).

  • “Quality Agreement” has the meaning set forth in Section 7.1(f).

  • “Receiving Party” has the meaning set forth in Section 9.1.

  • “Regulatory Approval” means, with respect to a Product in a country in the Territory, the approvals from the necessary Governmental Authority to import, market and sell such Product in such country (but excluding pricing approvals and reimbursement approvals).

  • “Regulatory Approval Application” means a New Drug Application or supplemental New Drug Application (“sNDA”) (each, as defined in the U.S. Federal Food, Drug and Cosmetic Act (21 U.S.C. §301 et seq.), as amended from time to time) in the U.S. Territory, or any corresponding application for approval to market or sell a product in any country, region or jurisdiction in the Territory.

  • “Regulatory Authority” means any applicable Governmental Authority responsible for granting Regulatory Approvals for any Product, including the FDA, and any corresponding national or regional regulatory authorities.

  • “Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a pharmaceutical product other than Patent, including orphan drug exclusivity, new chemical entity exclusivity, new clinical investigation exclusivity, data exclusivity or pediatric exclusivity.

  • “Regulatory Submissions” means any filing, application, or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Product.

  • “Relapsed or Refractory AML Mono Indication” means the use of the Product as a monotherapy in adult patients with relapsed or refractory NPM1-mutant AML.

  • “Research” means any and all research and discovery activities, including molecular biology, biochemistry, and pre-clinical pharmacology, in vitro assays, in vivo assays,

  • the identification of new biological agents, and activities related to the design, discovery, generation, identification, profiling, characterization, production, process development, cell line development, pre-clinical development or pre-clinical studies of drug candidates and products.

  • “Reserved Rights” has the meaning set forth in Section 2.1(c).

  • “Restricted Indication” means (a) [***], or (b) [***].

  • “Restricted Transfer” means a transfer or disclosure of Personal Data from a Party to the other Party where such transfer or disclosure would be prohibited by applicable Data Protection Laws in the absence of appropriate safeguards, including the Standard Contractual Clauses or UK International Data Transfer Addendum (as applicable).

  • “Reversion License” has the meaning set forth in Section 13.9(b)(i).

  • “Reversion Royalty” has the meaning set forth in Section 13.9(b)(ii).

  • “Royalty Payment” has the meaning set forth in Section 8.7(a).

  • “Royalty Term” has the meaning set forth in Section 8.7(b).

  • “Sales Call” means a personal visit, virtual visit (e.g., Zoom or similar) or phone detail by a Sales Representative to (a) one or several Target Prescribers, as well as (b) other Persons that have significant impact or influence on prescribing decisions for the indication(s) in which the Product is approved, including retail pharmacists, and ancillary staff in long-term care, skilled nursing facilities or assisted living facilities such as clinical pharmacists, directors of nursing, and certified nurse assistants.

  • “Sales Force Expense” means, with respect to a Product and a given Calendar Quarter, those costs that are identified below and that are incurred by a Partnership Party or its Affiliates (on behalf of such Partnership Party), in each case in accordance with the U.S. Territory Commercialization Plan and Budget and consistent with and specifically identifiable to the establishment and maintenance of sales personnel (including a field-based sales force, field payer team member and field managers) to the extent such personnel are, or will be, assigned to selling such Product in the U.S. Territory: [***].

  • “Sales Representative” means a pharmaceutical sales representative employed by either Party to conduct promotional efforts with respect to Products in accordance with the terms of this Agreement.

  • “SEC” means the U.S. Securities and Exchange Commission or any successor thereto.

  • “Selling and Promotion Expenses” means, with respect to a Product and a given Calendar Quarter, all costs (excluding [***]) incurred with respect to such Product in such Calendar Quarter by a Partnership Party or its Affiliates (on behalf of such Partnership Party) in accordance with the U.S. Territory Commercialization Plan and Budget, and specifically identifiable to the sales or promotion of such Product in the U.S. Territory, including [***].

  • “Share Percentage” means fifty percent (50%) to Kura and fifty percent (50%) to KKUS.

  • “Share Period” means, with respect to a Product, the period beginning on the First Commercial Sale of a Product in the U.S. Territory and ending the earlier of (a) the date that such Product ceases to be Commercialized by a Party or its Affiliate or Sublicensee in the U.S. Territory and (b) the earlier of the expiration of the U.S. Territory Term or the expiration or termination of this Agreement.

  • “Shared Commercial Cost Report” has the meaning set forth in Section 8.8(e)(i).

  • “Shared Commercial Costs” means, with respect to a Product and with respect to a Calendar Quarter, the sum of the following items incurred by a Partnership Party, in each case to the extent [***] to Commercialization of such Product in the U.S. Territory or Manufacturing activities in support of such Commercialization activities in such Calendar Quarter and in accordance with the U.S. Territory Commercialization Plan and Budget: [***].

  • “Shared Commercial Revenue” means, with respect to a Product and a given Calendar Quarter, subject to 4.4(c)(iv), Net Sales of such Product in the U.S. Territory during such Calendar Quarter, as well as any net proceeds (i.e., the sales price minus any costs associated with such sale) received by Kura arising from the sale of any priority review voucher issued by the FDA for a Product.

  • “Shared Development Costs” means all Development Costs incurred by Kura or KKUS or its Affiliates that are reasonably identified or allocable to any Development activities (including any Global Clinical Trial or any Local Clinical Trial in the U.S. Territory) under the Development Plan and Budget, including regulatory activities with respect to Products in the U.S. Territory, and Manufacturing activities in support of any of the foregoing activities, but shall exclude Development Costs incurred by Kura or KKUS or its Affiliates for Excluded Development Activities.

  • “Sole Invention” has the meaning set forth in Section 12.1(b).

  • “Solid Tumor Indication” means the use of the Product for patients with any cancer (other than any cancer specifically associated with (i) blood-forming tissue, such as the bone marrow, or (ii) the cells of the immune system, including, without limitation, leukemia, lymphoma, multiple myeloma and myelodysplastic syndrome). For clarity, Solid Tumor Indication includes the Gastrointestinal Stromal Tumor Indication.

  • “Standard Contractual Clauses” means the Commission Implementing Decision (EU) 2021/914 establishing Standard Contractual Clauses for data transfers to third countries (as amended, modified, or replaced from time to time); specifically, the applicable module within the Standard Contractual Clauses is MODULE ONE (Transfer Controller to Controller).

  • “Subcontractor” has the meaning set forth in Section 2.13.

  • “Sublicensee” means a Third Party granted a sublicense by KKJP or KKUS, as applicable, under the licenses granted to KKJP or KKUS, as applicable, in Section 2.1. For clarity, a Third Party granted a sublicense under such licenses by a Sublicensee shall also be deemed a Sublicensee.

  • “Supply Agreement” has the meaning set forth in Section 7.1(d).

  • “Tablet Formulation” means a Product containing the Compound as an active pharmaceutical ingredient in any dosage strength in a solid, oral tablet form, or in an alternative tablet form such as orally-disintegrating, sustained-release, or sublingual.

  • “Target Prescriber” means a medical or health care professional authorized to prescribe Products for any indication in the Field under the Applicable Laws of the jurisdiction in which such medical or health care professional is practicing.

  • “Tax” or “Taxes” means any present or future taxes, levies, imposts, duties, charges, assessments or fees in the nature of a tax (including any interest thereon). For the avoidance of doubt, Taxes includes VAT.

  • “Tax Appendix” the meaning set forth in Section 8.13(a).

  • “Term” has the meaning set forth in Section 13.1(a).

  • “Territory” means all countries and territories in the world.

  • “Third Party” means an entity other than (a) KKC and its Affiliates or (b) Kura and its Affiliates.

  • “Third Party Competitive Product” means [***].

  • “Third Party Infringement Claim” has the meaning set forth in Section 12.6(a).

  • “Third Party Infringement Notice” has the meaning set forth in Section 12.6(a).

  • “Third Party Payments” means, with respect to a Product and a given Calendar Quarter, all upfront payments, milestone payments, royalties, and other amounts paid to a Third Party by either Partnership Party or any of its Affiliates (on behalf of such Partnership Party), as applicable, under an Upstream Agreement or any other agreement pursuant to which a Partnership Party or its Affiliate acquired or obtained rights to Patents or Know-How, in each case, to the extent attributable to the Development, Manufacture, Commercialization or other Exploitation of such Product and related solely to the U.S. Territory.

  • “Third Party Technology” means any Patents or Know-How licensed to a Party by a Third Party that are necessary or reasonably useful to Develop, Manufacture, use or Commercialize the Compound or any Product in the Field in the Territory, but excluding Patents or Know-How that are licensed to a Party by a Third Party service provider or general vendor and are not material and not necessary to the Development, Manufacture or Commercialization of a Product in the Field in the Territory.

  • “Transition Period” has the meaning set forth in Section 13.9(b)(v).

  • “UK International Data Transfer Addendum” means the template Addendum B.1.0 issued by the UK Information Commissioner’s Office (ICO) and laid before Parliament in accordance with s119A of the Data Protection Act 2018 on 2 February 2022, as it is revised under Section ‎‎18 of the UK Mandatory Clauses included in Part 2 thereof.

  • “Upfront Payment” has the meaning set forth in Section 8.1.

  • “Upstream Agreement” means any agreement with a Third Party that is deemed an Upstream Agreement pursuant to Section 2.12.

  • “U.S. Development Milestone Event” has the meaning set forth in Section 8.2(a).

  • “U.S. Development Milestone Payment” has the meaning set forth in Section 8.2(a).

  • “U.S. Solid Tumor Development Milestone Event” has the meaning set forth in Section 8.4(a).

  • “U.S. Solid Tumor Development Milestone Payment” has the meaning set forth in Section 8.4(a).

  • “U.S. Territory” means the United States and its territories and possessions.

  • “U.S. Territory Commercialization Plan and Budget” has the meaning set forth in Section 5.2.

  • “U.S. Territory Field Expansion Option” has the meaning set forth in Section 2.8(a).

  • “U.S. Territory Term” means the period commencing on the Effective Date and continuing until the latest to occur of (a) the expiration of the last-to-expire Valid Claim of the Kura Patents Covering the composition of matter, pharmaceutical composition, Manufacture, use or sale of the Product (or the Compound contained therein) in the U.S. Territory; (b) the expiration of the last-to-expire Regulatory Exclusivity for the Product in the U.S. Territory; or (c) ten (10) years after the date of the First Commercial Sale of the Product in the U.S. Territory.

  • “United States” or “U.S.” means the United States of America and its territories and possessions.

  • [***].

  • “U.S. Dollars” or “$” means United States dollars, the lawful currency of the United States.

  • “Valid Claim” means a claim of (a) an issued and unexpired Kura Patent (including any Joint Patent included therein), which claim has not expired or irretrievably lapsed or been abandoned, dedicated to the public, revoked, held invalid or unenforceable by a patent office, court or other governmental agency of competent jurisdiction in a final order, from which no further appeal can be taken, and which claim has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise or (b) a pending patent application within the Kura Patents (including any Joint Patent included therein) that (i) has not been finally cancelled, withdrawn, abandoned or rejected by an administration agency action from which no appeal can be taken and (ii) has been pending for less than [***] years from the date of the first substantive office action therefor and is being prosecuted in good faith during such [***]-year period; provided that if such claim is later issued, it will from the issuance date forward, be deemed to be a Valid Claim, subject to clause (a).

  • “VAT” means value-added taxes or other similar taxes.

  • “Ven/Aza Indication” means the use of the Product together with the combination regimen of venetoclax and azacitidine in patients with newly-diagnosed NPM1-mutant or KMT2A-rearranged AML.

  • “Withholding Taxes” has the meaning set forth in Section 8.12(b).

  • “Ziftomenib Composition Patents” means (a) each patent application and patent set forth on Schedule 1.304 hereto; (b) any patents or patent applications [***], (c) [***], and (d) patents issued from the applications in the foregoing clauses (a), (b) and (c), including [***].

  • “Ziftomenib Transaction” has the meaning set forth in Section 2.11.

  • Licenses; exclusivity

  • License Grants to KKC.

  • U.S. Territory. Subject to the terms and conditions of this Agreement, Kura hereby grants, during the U.S. Territory Term, to KKUS:

  • a co-exclusive (with Kura and its Affiliates), payment-bearing license, with the right to grant sublicenses (solely in accordance with Section 2.3), under the Kura U.S. Technology (including, for clarity, a sublicense under the Ziftomenib Composition Patents licensed by Michigan to Kura under the Michigan License and, subject to Section 2.1(c), a sublicense under the MSK Patents licensed by MSK to Kura under the MSK License) to Develop and use the Compound and Products, in each case solely to the extent necessary for KKUS to perform the activities assigned to it under the Development Plan and Budget or to conduct an Expanded Indication Trial approved by the JSC in accordance with Section 4.4(c); and

  • a co-exclusive (with Kura and its Affiliates), payment-bearing license, with the right to grant sublicenses (solely in accordance with Section 2.3), under the Kura U.S. Technology to Commercialize the Products in the Field in the U.S. Territory and to conduct Medical Affairs activities in connection with the Commercialization of the Product in the Field in the U.S. Territory, in each case solely to the extent necessary for KKUS to perform the activities assigned to it under the U.S. Territory Commercialization Plan and Budget, and activities under the applicable Co-Promotion Agreement.

  • Ex-U.S. Territory. Subject to the terms and conditions of this Agreement, Kura hereby grants, during the Ex-U.S. Territory Term, to KKJP:

  • an exclusive (even as to Kura and its Affiliates, subject to Section 2.2), payment-bearing license, with the right to grant sublicenses (in multiple tiers, but solely in accordance with Section 2.3), under the Kura Ex‑U.S. Technology (including, for clarity, a sublicense under the Ziftomenib Composition Patents licensed by Michigan to Kura under the Michigan License and, subject to Section 2.1(c), a sublicense under the MSK Patents licensed by MSK to Kura under the MSK License) to Commercialize the Products in the Field in the Ex-U.S. Territory and conduct Medical Affairs activities solely in connection with the Commercialization of the Product in the Field in the Ex-U.S. Territory;

  • a co-exclusive (with Kura and its Affiliates, but solely to the extent necessary for Kura and its Affiliates to perform the activities assigned to it under the Development Plan and Budget, or to conduct Kura-Specific Development Activities, Expanded Indication Trials, Ex-U.S. Discretionary Development Activities or Marketing Trials, in each case as contemplated hereunder), payment-bearing license, with the right to grant sublicenses (in multiple tiers, but solely in accordance with Section 2.3), under the Kura Ex-U.S. Technology to Develop and use the Compound and Products in the Field solely for the Ex-U.S. Territory or to conduct an Expanded Indication Trial approved by the JSC in accordance with Section 4.4(c); and

  • a co-exclusive (with Kura and its Affiliates), payment-bearing license, with the right to grant sublicenses solely to a KKC CMO, under the Kura Manufacturing Technology to Manufacture the Products solely for Commercialization in the Field in the Ex-U.S. Territory.

For clarity, the licenses granted by Kura to KKC under this Section 2.1 shall not include any right or license to any of Kura’s proprietary compounds or Other Components other than the Compound.

  • Sublicense under MSK License. The Parties acknowledge and agree that, pursuant to that certain written consent provided by MSK to Kura, dated [***], sublicenses under the MSK Patents licensed by MSK to Kura under the MSK License will be granted to KKUS or KKJP as set forth in Sections 2.1(a) or 2.1(b).

  • Kura Retained Rights. Notwithstanding anything to the contrary in this Agreement, Kura hereby expressly retains, on behalf of itself and its Affiliates (a) all rights under the Kura Technology to, either itself or through its Affiliates or Subcontractors, fulfill Kura’s obligations or exercise Kura’s rights under this Agreement, including rights to conduct Development, Manufacturing, registration and Commercialization activities pursuant to this Agreement, the Development Plan and Budget, and the U.S. Territory Commercialization Plan and Budget; (b) the exclusive rights to Develop, use and Commercialize the Compound and Products outside the Field (including the practice of Kura Technology in connection therewith); (c) for clarity, the exclusive right, either itself or through its Affiliates, licensees or Subcontractors, under the Kura Manufacturing Technology to Manufacture and have Manufactured the Compound and Products for Exploitation in the U.S. Territory, and the co-exclusive right, either itself or through its Affiliates, licensees or Subcontractors, under the Kura Manufacturing Technology to Manufacture and have Manufactured the Products solely for Commercialization in the Field in the Ex-U.S. Territory and (d) the exclusive rights to use the Compounds for development of compounds and products that are not the Compound or any Product under this Agreement (the “Reserved Rights”).

  • Right to Sublicense.

  • By KKJP and KKUS. KKUS shall have the right to grant sublicenses under the licenses granted to it in Section 2.1(a) to [***]. KKJP shall have the right to grant sublicenses under the licenses granted to it in Section 2.1(b) to: [***]. Each of KKJP and KKUS remains primarily responsible for all of its obligations under this Agreement that have been delegated or sublicensed to any Affiliate, Sublicensee or Distributor and shall be liable for (I) its Affiliate’s, Sublicensee’s and Distributor’s conduct that is prohibited under this Agreement, and (II) its Affiliate’s, Sublicensee’s and Distributor’s breach of this Agreement

  • which shall be deemed a breach of this Agreement as if KKJP or KKUS, as applicable, had itself conducted the action or inaction that contributed to the breach of this Agreement.

  • KKJP and KKUS Restrictions. Each of KKJP and KKUS shall not grant a sublicense to any Affiliate or Third Party or appoint any Distributor that has been debarred or disqualified by any Governmental Authority, is a Prohibited Party, or is subject to any proceedings, sanctions or fines under any Anti-Corruption Law. Each of KKJP and KKUS shall ensure, prior to engaging any Third Party as a Sublicensee or Distributor that such Third Party is subject to written agreements containing terms and conditions that: (i) require each such Sublicensee or Distributor to protect and keep confidential any Confidential Information of the Parties, including in accordance with ARTICLE 9; (ii) provide Kura with the right to audit (either by itself or through KKJP or KKUS or their designee) the books and records of each such Sublicensee or Distributor in accordance with this Agreement (including pursuant to Sections 8.10(a), 8.10(c), and 10.5(a)(iii)); (iii) do not impose any payment obligations or liability on Kura; and (iv) are otherwise consistent with the terms of this Agreement in all material respects. Each of KKJP and KKUS shall provide a copy of the complete executed agreement with each Sublicensee or Distributor to Kura; provided that KKJP or KKUS, as applicable, shall be permitted to redact commercially sensitive economic terms of any such agreement which terms are not necessary for Kura to confirm KKJP’s or KKUS’s compliance with its obligations hereunder.

  • By Kura. Kura shall have the right to grant sublicenses under the licenses granted in Section 2.4 to [***]. Kura remains primarily responsible for all of its obligations under this Agreement that have been delegated or sublicensed to any Affiliate and shall be liable for (i) its Affiliate’s conduct that is prohibited under this Agreement, and (ii) its Affiliate’s breach of this Agreement which shall be deemed a breach of this Agreement as if Kura had itself conducted the action or inaction that contributed to the breach of this Agreement. [***].

  • License Grants to Kura.

  • Subject to the terms and conditions of this Agreement, KKC hereby grants to Kura during the Term a non-exclusive, sublicensable (solely as permitted in accordance with Section 2.3(c)), royalty-free, fully-paid license, under the KKC Technology (i) to conduct Development and Manufacturing activities in the Territory solely in accordance with this Agreement and solely to the extent necessary for Kura to perform the activities assigned to it under the Development Plan and Budget, to conduct Expanded Indication Trials, Discretionary Development Activities or Kura-Specific Development Activities, in each case as contemplated hereunder, and (ii) to Commercialize the Products in the U.S. Territory and to conduct Medical Affairs activities solely in accordance with this Agreement and solely to the extent necessary for Kura to perform the activities assigned to it under the U.S. Territory Commercialization Plan and Budget or to conduct Discretionary Commercialization or Medical Affairs Activities as contemplated hereunder.

  • In addition, KKC hereby grants to Kura [***].

  • [***].

  • Access to Know-How.

  • Kura shall, without additional consideration, provide or make available to KKC all Kura Know-How that exists as of the Effective Date, which provision or access shall occur in a manner and following a reasonable schedule agreed by the Parties. If Kura reasonably and in good faith determines that the delivery of such Kura Know-How is complete, it shall provide KKC prompt written notice thereof, following which KKC shall have a period of [***] days to identify any missing, incomplete or otherwise non-compliant or deficient documents or data in with respect to such provision or access (“Handover Deficiencies”). If KKC fails to identify and notify Kura of any outstanding Handover Deficiencies within [***]-day period, the applicable handover will be deemed complete. At any time prior to Kura’s written confirmation of the completion of such provision of access or the lapsing of such [***]-day period, KKC may provide written notice to Kura of any such Handover Deficiencies. Upon receipt of any such notice, Kura, without additional consideration, shall [***].

  • Without limiting the foregoing, during the Term, Kura shall provide or make available KKC with additional Kura Know-How, to the extent that such Kura Know-How comes to Kura’s attention (or is reasonably requested by KKC), is within the scope of the current licenses to KKC hereunder, and has not previously been provided or made available to KKC. During the Term, KKC shall provide or make available Kura with Know-How within the KKC Technology, to the extent that such Know-How comes to KKC’s attention (or is reasonably requested by Kura), is within the scope of the current licenses to Kura hereunder, and has not previously been provided or made available to Kura. Such Know-How shall include [***].

  • No Implied Licenses. Except as set forth herein, neither Party shall acquire any license or other intellectual property interest, either expressly or by implication, estoppel or otherwise, under any Know-How, Patents or other intellectual property of the other Party.

  • Negative Covenants.

  • During the Term, KKC shall not, and shall not grant a license or enable any Third Party to, directly or indirectly, (i) use or practice any Kura Technology in the Research, Development, Manufacture, Commercialization or other Exploitation of any Compound or Product outside of the Field, or (ii) promote, sell, solicit the sale of, or otherwise Commercialize, or encourage Third Parties to use, any Compound or Product outside of the Field;

  • During the U.S. Territory Term for the U.S. Territory or during the Royalty Term for each country in the Ex-U.S. Territory and on a country-by-country basis, as applicable, Kura shall not, and shall not grant a license or enable any Third Party to, directly or indirectly, [***]; and

  • During the U.S. Territory Term for the U.S. Territory or during the Royalty Term for each country in the Ex-U.S. Territory and on a country-by-country basis, as applicable, except as otherwise agreed by the Parties in writing (including an amendment of Kura’s obligations under Section 2.10 of this Agreement), Kura shall not, and shall not grant a license or enable any Third Party to, directly or indirectly, [***].

  • Field Expansion Option.

  • Kura hereby grants to (i) KKUS, an exclusive option to expand the Field of the license granted under Section 2.1(a), and (ii) KKJP, an exclusive option to expand the

  • Field of the license granted under Section 2.1(b); in each case to include the prophylactic, diagnostic or therapeutic uses for all cancers, including solid tumors, in humans (the option set forth in the foregoing clause (i), the “U.S. Territory Field Expansion Option”, and the option set forth in the foregoing clause (ii), the “Ex-U.S. Territory Field Expansion Option”, and together with the U.S. Territory Field Expansion Option, the “Field Expansion Option”).

  • Upon the completion of the [***] of the Product for any solid tumor by or on behalf of Kura, Kura shall provide to KKUS and KKJP a data package that includes: [***] (the “POC Data Package”). Within [***] Business Days following KKC’s receipt of such POC Data Package, KKUS or KKJP may make reasonable inquiries of Kura for further clarification and information with respect to the data and information included in such POC Data Package, and Kura shall reasonably cooperate with KKUS and KKJP to respond to such inquiries and provide further data or information requested by KKUS or KKJP, provided that in no event shall Kura be required to conduct any additional activities or studies. Within [***] days following KKUS’s and KKJP’s receipt of such POC Data Package (such time period, the “Field Expansion Option Period”), each of KKUS and KKJP shall have the right to exercise its Field Expansion Option by providing a written notice thereof to Kura (and for clarity, if either KKUS or KKJP exercises its applicable Field Expansion Option, the other entity shall also be deemed to exercise its Field Expansion Option). Within [***] days following the delivery of such notice, (A) KKUS shall pay Kura an amount of [***] Dollars ($[***]) in consideration for the exercise of the U.S. Territory Field Expansion Option, and (B) KKJP shall pay Kura an amount of [***] Dollars ($[***]) in consideration for the exercise of the Ex-U.S. Territory Field Expansion Option (the amount set forth in clause (A) and (B) in the aggregate amount of [***] Dollars ($[***]), the “Field Expansion Option Exercise Payment”).

  • If KKUS and KKJP exercise the Field Expansion Option during the Field Expansion Option Period, then effective upon the Field Expansion Effective Date, (i) the license granted by Kura to KKUS under Section 2.1(a) shall include the expanded definition of Field as set forth in clause (b) of Section 1.105, and Kura and KKUS will share Shared Development Costs for such Development in accordance with Section 4.9, (ii) the license granted by Kura to KKJP under Section 2.1(b) shall include the expanded definition of Field as set forth in clause (b) of Section 1.105 and (iii) KKUS and KKJP shall pay the milestones set forth in Sections 8.4 and 8.5 when achieved with respect to Products for Solid Tumor Indications, and royalties on Net Sales of Products for Solid Tumor Indications in accordance with Section 8.7 (as calculated by including such Net Sales of Products for Solid Tumor Indications into the aggregate total Net Sales of the Products), in each case with respect to the U.S. Territory and Ex-U.S. Territory, as applicable.

  • If KKC does not exercise the Field Expansion Option during the Field Expansion Option Period, then (i) each of KKJP and KKUS shall have no rights with respect to the Development, use and Commercialization of the Product in solid tumors or otherwise outside of the Field in the U.S. Territory or the Ex-U.S. Territory, and (ii) without limiting Kura’s rights in Section 2.2(b), Kura shall have the right, but not the obligation, to grant rights (including exclusive rights) to a Third Party to Develop, use or Commercialize the Compound and Products for solid tumors in the Territory, at Kura’s sole discretion.

  • Authorized Generic. If Kura develops, itself or through or with its Affiliate or any Third Party, an Authorized Generic which could be used in the Field in the U.S. Territory, Kura will notify KKC in writing promptly following the submission of any application to the Regulatory Authority in the U.S. Territory for such Authorized Generic. KKC shall have [***] Business Days following receipt of such notice (the “Authorized Generic Election Period”)

  • to elect to negotiate with Kura the terms of a potential commercial partnership with respect to such Authorized Generic in the Territory by providing written notice to Kura (such notice, an “Authorized Generic Election Notice”). Following Kura’s receipt of the Authorized Generic Election Notice, Kura and KKC shall negotiate in good faith the terms for such commercial partnership for a period of [***] days (or such longer period as may be mutually agreed by the Parties) (the “Authorized Generic Negotiation Period”). If KKC does not provide Kura with an Authorized Generic Election Notice within the Authorized Generic Election Period or if the Parties do not enter into a definitive agreement with respect to such Authorized Generic prior to the expiration of the Authorized Generic Negotiation Period, [***]. For clarity, nothing in this Section 2.9 obligates either Party to enter into a definitive agreement with respect to such Authorized Generic.

  • Exclusivity.

  • Exclusive Use.

  • During the U.S. Territory Term, except as provided in Section 2.10(b) or otherwise expressly contemplated under this Agreement, (A) Kura shall not, and shall cause its Affiliates and Sublicensees not to, engage in (independently or for or with any Third Party) [***] other than with respect to the Compound and Products as permitted under this Agreement, and (B) KKUS shall not, and shall cause its Affiliates and Sublicensees not to, engage in (independently or for or with any Third Party) [***] other than with respect to the Compound and Products as permitted under this Agreement.

  • During the Royalty Term for each country in the Ex-U.S. Territory and on a country-by-country basis, except as provided in Section 2.10(b) or otherwise expressly contemplated under this Agreement, (A) Kura shall not, and shall cause its Affiliates and Sublicensees not to, engage in (independently or for or with any Third Party) [***] other than with respect to the Compound and Products as permitted under this Agreement and (B) KKJP shall not, and shall cause its Affiliates and Sublicensees not to, engage in (independently or for or with any Third Party) [***] other than with respect to the Compound and Products as permitted under this Agreement.

  • Change of Control; Acquisition.

  • Change of Control. In the event that either Party undergoes a Change of Control with a Third Party (an “Acquirer”), [***].

  • Acquisition of a Third Party. In the event that either Party or any of its Affiliates (excluding, with respect to KKC, Kirin Holdings Company, Limited and its subsidiaries (other than KKC), which shall not be considered Affiliates of KKC for the purposes of this subsection (b)(2)) (collectively as the “Acquiring Party”) merges or consolidates with, or otherwise acquires a Third Party (whether such transaction occurs by way of a sale of assets, merger, consolidation or similar transaction, but excluding a Change of Control of such Party) (an “Acquired Entity”) that is performing any Competing Activities at the closing of such transaction, the other Party shall have the right to terminate this Agreement with an immediate effect upon written notice to the Acquiring Party at any time after twelve (12) months following such closing unless by the end of such twelve (12) month period, [***].

  • Right of Notice. During the term of this Agreement, upon the earlier of [***] shall (and [***] shall require [***] to) promptly notify [***] in writing, in the case of [***] prior to

  • commencing any such [***]. In such event, such notice (the “Transaction Notice”) shall include [***]. After delivery of the Transaction Notice to [***], each of [***] shall have no further obligations under this Section 2.11. As used in this Section 2.11, “Ziftomenib Transaction” means [***].

  • Third Party Agreements.

  • Existing Agreements.

  • Michigan License. To the extent that the licenses granted by Kura to KKC under Section 2.1 constitutes the grant of a sublicense by Kura to KKC of Ziftomenib Composition Patents that are in-licensed by Kura pursuant to that certain Michigan License, KKC hereby acknowledges and agrees that its sublicense with respect to such Ziftomenib Composition Patents are subject to the terms and conditions of the Michigan License, and KKC shall comply with, and shall cause its Affiliates and Sublicensees to comply with, the relevant terms applicable to sublicensees under the Michigan License, including: (A) the requirement to mark the Products embodying the Ziftomenib Composition Patents or produced through the use of Ziftomenib Composition Patents sold in the U.S. with all applicable patent numbers as necessary to meet the requirements of 35 U.S.C. § 287 so that the full benefits of patent enforcement may be realized, as set forth in Section 13.4 of the Michigan License; (B) the requirement that all Products embodying the Ziftomenib Composition Patents or produced through the use of Ziftomenib Composition Patents shipped to or sold in countries in the Ex-U.S. Territory be marked to comply with the applicable patent laws and practices of the countries of manufacture, use and sale in the Ex-U.S. Territory, as set forth in Section 13.4 of the Michigan License; (C) the requirement for KKC to keep true and accurate records containing data reasonably required for the computation and verification of payments due under the Michigan License, and KKC’s obligation to (1) open such records for inspection upon reasonable notice during business hours, and no more than [***] per year, by an independent certified accountant selected by Michigan, for the purpose of verifying the amount of payments due under the Michigan License, and shall provide information to Michigan to facilitate such inspection, and (2) retain such records for [***] years from the date of the payment to which they pertain, as set forth in Section 4.4 of the Michigan License; and (D) the requirement that KKC refrain from using the name of Michigan, [***], Foundation, LLS or their employees in publicity or advertising without the prior written approval of Michigan, [***], Foundation or LLS, as the case may be, provided that KKC may state publicly that Products were developed by Kura based upon an invention(s) developed at the University of Michigan or [***] and/or that Patents were licensed from the University of Michigan and [***], as set forth in Section 13.6 of the Michigan License. If Kura requires any additional information relating to Products to comply with its reporting obligations pursuant to Article 4 of the Michigan License, KKC shall promptly provide such information upon Kura’s written request. Any royalties on Net Sales due under the Michigan License that result from or are attributable to Products Developed or Commercialized by Kura, KKUS or any of its or their Affiliates or Sublicensees under this Agreement in the U.S. Territory shall be [***]. In addition, Kura shall be responsible for complying with all provisions under the Michigan License, including the obligation to notify Michigan within [***] days of the Effective Date of this Agreement for Kura’s grant of a sublicense to KKC hereunder (and Kura shall provide notice to KKC of the same following notification to Michigan).

  • MSK License. To the extent that the licenses granted by Kura to KKC under Section 2.1 constitute the grant of a sublicense by Kura to KKC of MSK Patents, KKC hereby acknowledges and agrees that its sublicense with respect to such MSK Patents are

  • subject to the terms and conditions of the MSK License, and KKC shall comply with, and shall cause its Affiliates and Sublicensees to comply with, the relevant terms applicable to sublicensees under the MSK License, including: (A) the reservation of rights in favor of the U.S. government pursuant to 35 U.S.C. § 200 et seq. and implementing regulations and agreements, as set forth in Section 2.2 of the MSK License; (B) the requirement for KKC to keep true and accurate records containing data reasonably required for the computation and verification of payments due under the MSK License, and KKC’s obligation to (1) open such records for inspection upon reasonable notice during business hours (no more than [***] per year) for the purpose of verifying the amount of payments due under the MSK License, as described in Section 6.1 of the MSK License and (2) retain such records for [***] years following the period to which they pertain, as set forth in Section 6.1 of the MSK License; (C) the requirement that KKC refrain from challenging the validity or enforceability of any claim within the MSK Patents, and in the event that KKC does challenge such MSK Patents and is unsuccessful, the obligation to reimburse MSK for all costs and expenses incurred by MSK as a result of defending such challenge, as set forth in Section 7.4 of the MSK License; (D) the requirement that all disputes or claims pertaining to the MSK License (including the MSK Patents) be governed by [***] law and that the state and federal courts located in [***] shall have exclusive jurisdiction with respect to such disputes or claims, as set forth in Sections 18.1 and 18.2 of the MSK License; (E) the requirement that KKC shall comply with export control laws, as set forth in Section 12.1 of the MSK License; (F) the requirement that KKC conduct all activities in respect of the MSK Patents in full compliance with all applicable laws and regulations, as set forth in Section 12.2 of the MSK License; (G) the requirement for KKC to mark, and require all Affiliates and Sublicensees to mark, any Products (or the packaging thereof) manufactured by KKC, its Affiliates or Sublicensees, with the appropriate patent numbers of the MSK Patents, to the extent required by law or if such failure to mark would reduce the rights to enforce such MSK Patents against a Third Party, as set forth in Section 12.4 of the MSK License; (H) the requirement that KKC refrain from using the name of MSK, or any of its employees, in any press release, advertising, promotional or sales literature, or any trademark of MSK, in each case without the prior written consent of MSK, as more fully described in Article 13 of the MSK License; and the right for MSK to publish the scientific findings from research related to the MSK Patents, subject to the terms and conditions of Article 14 of the MSK License; and (I) the right for MSK to publish the scientific findings from research related to the MSK Patents, subject to the terms and conditions of Article 14 of the MSK License. If Kura requires any additional information relating to Products to comply with its reporting obligations pursuant to Section 6.1 of the MSK License, KKC shall promptly provide such information upon Kura’s written request. Any royalties on Net Sales due under the MSK License that result from or are attributable to Products Developed or Commercialized by Kura, KKUS or any of its or their Affiliates or Sublicensees under this Agreement in the U.S. Territory shall be [***].

  • Additional Upstream Agreements.

  • During the Term, each Party shall promptly notify the other Party if it becomes aware of any Third Party Technology that is necessary or reasonably useful for the Exploitation of the Compound or Product in the Field in the Territory. Unless otherwise agreed by the Parties, (A) Kura shall have the first right to negotiate and acquire or obtain a sublicensable (in accordance with the terms of this Agreement) license from such Third Party under such Third Party Technology for the Territory (provided that Kura shall: (i) provide KKC with a summary of the terms and conditions of the proposed agreement or a copy of the agreement before executing such license; (ii) provide KKC with sufficient time to review such

  • summary or proposed agreement and (iii) meet and discuss with KKC in good faith the proposed agreement and any such terms and conditions and consider in good faith any comments provided by KKC with respect thereto), and (B) if Kura elects not to or is unable to obtain such a license or other acquisition of such rights, KKC shall have the right, but not the obligation, to obtain a license under, or acquire, such rights, subject to Section 2.12(b)(ii). Any such agreement executed by a Party pursuant to this Section 2.12(b)(i) shall be deemed an “Upstream Agreement”. Each Party shall ensure that the terms of such Upstream Agreements are consistent with this Agreement in all material respects and do not limit the other Party’s rights or interests or increase the other Party’s obligations hereunder (except with respect to any payments, royalties or other payments payable to such Third Party). Any Third Party Technology licensed or acquired under an Upstream Agreement executed by Kura (and for which KKC has consented to including the applicable Know-How or Patents in the Kura Technology) shall be included in the Kura Technology to the extent necessary or reasonably useful for the Development, Manufacture or Commercialization of the Compound or Products in the Field in the Territory or to the extent such Third Party Technology would constitute Kura Technology. Any Third Party Technology licensed or acquired under an Upstream Agreement executed by KKC pursuant to this Section 2.12(b)(i) shall be deemed included in the KKC Technology to the extent necessary or reasonably useful for the Development, Manufacture or Commercialization of the Compound or Products in the Field in the Ex-U.S. Territory or to the extent such Third Party Technology would constitute KKC Technology. All upfront payments, milestone payments, royalties and other amounts paid to Third Parties pursuant to any such licenses executed pursuant to this Section 2.12(b)(i), (1) to the extent arising from the activities by or on behalf of a Party under this Agreement and related solely to the U.S. Territory, shall be included in Third Party Payments and shared by the Parties in accordance with Section 8.8 and (2) to the extent arising from the activities by or on behalf of KKC under this Agreement and related solely to the Ex-U.S. Territory, shall be borne by KKC. Any royalties paid by KKC to a Third Party under an Upstream Agreement shall be subject to Section 8.7(c)(iii) (if meeting the requirements thereunder) as applicable to the Ex-U.S. Territory only.

  • If KKC obtains a license to Third Party Technology under an Upstream Agreement, KKC will ensure that it has the right to sublicense its rights thereunder to Kura, including in the event of any termination of this Agreement as set forth in Section 13.9(b)(i).

  • Additional Covenants

  • Neither Party shall, and neither Party shall cause its Affiliates to, modify, amend, or terminate any Upstream Agreement or waive any right or obligation thereunder in any way that would adversely affect in any material respect the other Party’s rights or interests under this Agreement, in each case, without such other Party’s prior written consent, not to be unreasonably withheld, conditioned, or delayed;

  • Neither Party shall, and neither Party shall cause its Affiliates to, take or omit to take any action that would constitute a material breach of any covenant, agreement or obligation under any Upstream Agreement in a manner that would reasonably be expected to give the counterparty to any such agreement the right to terminate or otherwise alter (in a manner adverse to the other Party or any of its Affiliates or their respective (sub)licensees) such Party’s rights under such Upstream Agreement, and as between the Parties, any material breach under the Upstream Agreement in a manner that adversely impacts the other Party’s rights thereunder shall be deemed a material breach of this Agreement by the Party causing such material breach; and

  • In the event that a Party or any of its Affiliates receives notice of an alleged breach by such Party or any of its Affiliates under any Upstream Agreement, then such Party shall promptly, but in no event less than [***] Business Days thereafter, provide written notice thereof to the other Party. Subject to the allegedly breaching Party’s right to dispute such breach as permitted under such Upstream Agreement, the allegedly breaching Party shall have the first right to cure such breach [***]. If the allegedly breaching Party does not desire to cure such breach, then such allegedly breaching Party shall, at the non-breaching Party’s election provided by written notice to the allegedly breaching Party: (x) solely with respect to an alleged payment breach not disputed by the alleged breaching Party in accordance with the terms of the applicable Upstream Agreement, grant the other Party the right (but not the obligation) to cure such alleged payment breach on behalf of such allegedly breaching Party [***] or (y) if the non-breaching Party reasonably determines that such breach is not reasonably curable, then the allegedly breaching Party shall use reasonable efforts to assist the non-breaching Party or enter into a direct license with the applicable counterparty of the Upstream Agreement, [***].

  • Use of Subcontractors. Each Party may perform its activities under this Agreement through one or more subcontractors, so long as (a) such Party remains responsible for the work allocated to, and payment to, such subcontractors to the same extent it would if it had done such work itself, (b) each subcontractor undertakes in writing obligations of Personal Data protection (if applicable), confidentiality and non-use regarding Confidential Information consistent with this Agreement, and (c) each subcontractor agrees in writing to assign to such Party all intellectual property developed in the course of performing any such work (excluding improvements made by such subcontractor to any background intellectual property owned by such subcontractor) (such permitted subcontractor, a “Subcontractor”).

  • GOVERNANCE

  • Alliance Managers. Within [***] days following the Effective Date, each Party shall appoint (and notify the other Party of the identity of) a representative having the appropriate qualifications (including a general understanding of pharmaceutical Development, Manufacturing, Regulatory Approval and Commercialization issues) to act as its alliance manager regarding Development, Manufacture, registration and Commercialization of the Products in the Territory pursuant to this Agreement (the “Alliance Manager”). The Alliance Managers shall serve as the initial primary contact points between the Parties regarding the Development, Manufacture and Commercialization activities in the Territory contemplated under this Agreement (until contacts within each function are identified). The Alliance Managers shall (a) facilitate the flow of information; (b) otherwise promote communication, coordination and collaboration between the Parties by providing support for seeking consensus both internally within each Party’s respective organization, and raising cross-Party or cross-functional disputes in a timely manner. Management of Committee meetings including (i) calling meetings of the Committees and (ii) ensuring minutes of each such meeting are prepared and circulated within [***] Business Days thereafter will be the responsibility of the Alliance Manager and/or relevant function leads. Each Party may replace its Alliance Manager by written notice to the other Party.

  • Joint Steering Committee.

  • Formation. Within [***] days after the Effective Date, the Parties shall establish a joint steering committee (the “JSC”), which shall have overall responsibility for the collaboration between the Parties under this Agreement, including coordinating and overseeing all Development and Commercialization activities of the Products in the U.S. Territory and Ex-U.S. Territory, and serving as a decision-making forum with respect to matters within the purview of the JSC, all in accordance with this Section 3.2. The JSC shall be comprised of three (3) representatives (or such other equal number of representatives as agreed by the Parties in writing) appointed by each Party, each of whom shall have appropriate knowledge and expertise and sufficient seniority within the applicable Party to make decisions arising within the scope of the JSC’s responsibilities. Each Party may replace its JSC representatives upon written notice to the other Party. Upon the JSC’s establishment, each Party will designate one of its JSC representatives as a co-chairperson. The co-chairperson shall not have any greater authority than any other representative of the JSC.

  • Role. In addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreement, the JSC shall in particular:

  • oversee, review and discuss the overall strategy for the Development, Manufacture, Regulatory Approval and Commercialization of the Products in the Field in the U.S. Territory during the U.S. Territory Term and in the Ex-U.S. Territory during the Ex-U.S. Territory Term;

  • review and discuss updates on the Development, Manufacture, Regulatory Approval and Commercialization of the Products in the Field in the U.S. Territory during the U.S. Territory Term and in the Ex-U.S. Territory during the Ex-U.S. Territory Term;

  • oversee the activities of the JCC, the JDC, the JMC, and any other subcommittee established by the JSC, resolving any matter as to which the JCC, the JDC, the JMC or other subcommittee has authority but cannot reach agreement, subject to Section 3.2(c);

  • approve the U.S. Territory Commercialization Plan and Budget and any amendments thereto;

  • approve the Global Branding Strategy;

  • approve the Global Pricing Strategy;

  • approve the Global Product Strategy;

  • review and comment on the Ex-U.S. Territory Commercialization Plan;

  • review, discuss and make decisions with respect to registration, product strategy, pricing policy and Commercialization of Products in the U.S. Territory during the U.S. Territory Term;

  • resolve any dispute regarding [***].

  • discuss whether any Clinical Trials that are not included in the Development Plan and Budget are reasonably necessary for obtaining or maintaining Regulatory Approval of any Product for an indication in which such Product being Developed or Commercialized by the Parties under this Agreement, including any Post-Marketing Commitments (“Mandatory Development Activities”);

  • oversee all data generation plans and data generation studies including Medical Affairs plans, Health Economics and Outcomes Research (HEOR), Real-World Evidence (RWE), and Investigator Sponsored Trials (IST), in each case, as applicable to the Products in the Field in the U.S. Territory during the U.S. Territory Term and in the Ex-U.S. Territory during the Ex-U.S. Territory Term;

  • address obligations under applicable Data Protection Laws which includes allocating the Parties’ respective roles as a Controller or Joint Controller of Personal Data;

  • allocate budgeted resources (to the extent applicable) and determine priorities for each Clinical Trial under the Development Plan and Budget;

  • approve the conduct of any proposed Expanded Indication Trials [***];

  • approve amendments to the Development Plan and Budget, subject to Section 4.4(b);

  • approve amendments to the Ex-U.S. Territory Development Plan;

  • review strategies for obtaining, maintaining, defending and enforcing trademark protection for Products in the Field in the U.S. Territory during the U.S. Territory Term and in the Ex-U.S. Territory in the Ex-U.S. Territory Term;

  • establish subcommittees as necessary or advisable to further the purpose of this Agreement, including a Medical Affairs subcommittee; and

  • perform such other functions as expressly set forth in this Agreement or allocated to it by the Parties’ written agreement.

  • Decision-Making. All decisions of the JSC shall be made by unanimous vote, with Kura’s representatives collectively having one (1) vote and KKC’s representatives collectively having one (1) vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC, the JSC cannot reach a decision as to such matter within [***] Business Days after such matter was brought to the JSC for resolution, such matter shall be referred by the Parties’ Alliance Managers to the Chief Executive Officer of Kura (or a senior officer designated by the Chief Executive Officer of Kura) and the President and CEO of KKC (or a senior officer designated by the President and CEO of KKC) (the “Executive Officers”) for resolution. If the Executive Officers cannot resolve such matter within [***] Business Days after such matter has been referred to them, then the Parties shall be deemed to be deadlocked and:

  • except with respect to Critical Matters, Kura shall have the final decision-making authority with respect to any matters pertaining to (A) the Development or Commercialization of Products in the U.S. Territory, including all decisions regarding obtaining Regulatory Approval for the Products in the U.S. Territory; (B) the conduct of Clinical Trials of the Products in the U.S. Territory; (C) the preparation, submission and maintenance of Regulatory Submissions for the Products in the U.S. Territory; (D) the Manufacture and supply of Products by Kura for the U.S. Territory, or (E) the Manufacture and supply of Products for the Ex-U.S. Territory until the Manufacturing Technology Transfer; [***].

  • except with respect to Critical Matters, KKJP shall have final decision-making authority over any matters pertaining to (A) the Development (including the conduct of Clinical Trials of the Product) or Commercialization of Products, in each case solely for use in the Field and in the Ex-U.S. Territory (and not for the U.S. Territory), (B) the preparation, submission and maintenance of Regulatory Submissions for the Products in the Ex-U.S. Territory or (C) after Manufacturing Technology Transfer, the Manufacture and supply of Products for the Ex-U.S. Territory; [***];

  • all decisions of the Executive Officers with respect to any Critical Matter will be made by consensus, except (A) with respect to compliance, product safety or quality matters with respect to the U.S. Territory (which will be made by the Executive Officer of Kura), and (B) with respect to compliance, product safety or quality matters with respect to the Ex-U.S. Territory (which will be made by the Executive Officer of KKC), provided that if the Executive Officers cannot agree within [***] days, such dispute shall be resolved by expedited arbitration in accordance with Schedule 3.2(c);

  • notwithstanding anything to the contrary in this Agreement, if in the good faith determination of either Party, resolution of any Critical Matter requires exigent action pursuant to Applicable Laws or to prevent a material adverse effect on the Development or Commercialization of the Products or patients, (A) Kura will have the right to make an interim decision for an exigent action within the U.S. Territory and (B) KKC will have the right to make an interim decision for an exigent action within the Ex-U.S. Territory, in each case pending such determination by the Executive Officers; provided that prior to making any such exigent actions, each Party shall use reasonable efforts, if possible in a reasonable time-frame determined by the Party with the right to make such interim decision, to: (x) notify the other Party of the need for such exigent action; (y) solicit the other Party’s feedback (and the other Party shall reasonably cooperate to provide such feedback within the time-frame required by the Party with the right to make such interim decision on an accelerated basis) and (z) subject to the other Party providing feedback within the required time-frame, consider such feedback in good faith when taking such exigent action;

  • [***]; and

  • for clarity and notwithstanding anything to the contrary in this Section 3.2(c), a Party assigned responsibility for a task will have control over day-to-day decisions related to operationalizing such task, and such day-to-day decision shall not be subject to the other Party’s final decision-making authority.

  • Exchange of Information. The Partnership Parties shall cooperate to exchange information through the JSC with respect to its activities under this Agreement and the Development, Manufacture, registration and Commercialization of the Products and

  • Medical Affairs activities conducted by each Partnership Party and their Affiliates (on behalf of such Partnership Party) in the U.S. Territory during the U.S. Territory Term. Kura and KKJP shall cooperate to exchange information through the JSC with respect to its activities under this Agreement and the Development, Manufacture, registration and Commercialization of the Products and Medical Affairs activities in the Territory conducted by each Party and their Affiliates, and in the case of KKJP, its Sublicensees.

  • Joint Development Committee.

  • Formation. In accordance with Section 3.2(b)(xix), the JSC shall establish a subcommittee to review and oversee the Development and registration of the Products in the Territory and to coordinate the Parties’ activities under this Agreement with respect to the Development and registration of the Products in accordance with the Development Plan and Budget (the “JDC”) within [***] days after the Effective Date all in accordance with this Section 3.3. The JDC shall be comprised of four (4) representatives (two (2) from each Party or such other equal number of representatives as agreed by the Parties in writing), each of which shall have sufficient seniority within such Party and relevant expertise to make decisions arising within the scope of the JDC’s responsibilities. Each Party may replace its JDC representatives upon written notice to the other Party. A member of the JDC may also be a member of the JSC or any other Committee if so desired by the Party who appoints such member.

  • Role. In addition to its overall responsibility for review, oversight and coordination of the Parties’ Development and regulatory activities with respect to Products under this Agreement, the JDC shall:

  • provide a forum for the discussion of the Parties’ Development activities with Products in the Field in the Territory and status of Regulatory Submissions and Regulatory Approvals in the Field in the Territory and exchange of data and information generated from each Party and, in the case of KKC, its Sublicensees;

  • provide strategic oversight for pharmacovigilance and safety activities with respect to the Product in the U.S. Territory and Ex-U.S. Territory, and matters relating to Regulatory Approvals, medical affairs, and clinical and non-clinical Development;

  • review and discuss amendments to the Development Plan and Budget, subject to Section 4.4(b) for submission to the JSC;

  • review and discuss amendments to the Ex-U.S. Territory Development Plan for submission to the JSC;

  • discuss and approve addenda to the Development Plan and Budget that are specific to Clinical Trials or Development activities setting forth the allocation of FTE responsibilities;

  • review and update monthly financial forecasts to assess actual and anticipated spend in light of the approved budget in the then-current Development Plan and Budget;

  • review data generated from the Clinical Trials of the Products in the Field in the U.S. Territory during the U.S. Territory Term and in the Ex-U.S. Territory during the Ex-U.S. Territory Term;

  • create, implement and review the overall strategy for Development and the design and objectives of all Clinical Trials conducted under the Development Plan and Budget (other than any Phase 4 Clinical Trials, Non-Interventional Studies and Post-Marketing Commitment). For Clinical Trials that are not included in the Development Plan and Budget, the JDC will form a joint development working group for each study with members from each Party (as designated by such Party) that will prepare and make recommendations on study design (including objectives, study endpoints, population, sample size, duration and statistical analysis plan) and the execution of such studies to the JDC and the JDC will review and approve the final study design and protocols for such studies;

  • decide whether and when to initiate or discontinue, and oversee the conduct of, any Clinical Trial conducted under the Development Plan and Budget;

  • allocate budgeted resources (to the extent applicable) and determine priorities for each Clinical Trial conducted under the Development Plan and Budget;

  • allocate primary responsibility as between the Partnership Parties for tasks relating to Development or Regulatory Submissions and Regulatory Approval of Products in the Field in the U.S. Territory where not already specified in the Development Plan and Budget;

  • address obligations under applicable Data Protection Laws which includes allocating the Parties’ respective roles as a Controller or Joint Controller of Personal Data;

  • facilitate the flow of information between the Parties with respect to Development and regulatory activities for Products in the Field in the Territory;

  • provide a forum for reviewing, discussing and approving a Global Publication Strategy in relation to the Products in the Field in the Territory;

  • oversee, review, discuss and coordinate the preparation for submission of, and maintenance of (as applicable) the Regulatory Approval Applications and other Regulatory Submissions for Products in the Field in the U.S. Territory during the U.S. Territory Term and in the Ex-U.S. Territory during the Ex-U.S. Territory Term; and

  • perform such other functions as expressly set forth in this Agreement or allocated to it by the Parties’ written agreement.

  • Decision-Making. All decisions of the JDC shall be made by unanimous vote, with Kura’s representatives collectively having one (1) vote and KKC’s representatives collectively having one (1) vote. If, after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JDC, the JDC cannot reach a decision as to such matter within [***] days after such matter was brought to the JSC for resolution, such matter shall be referred by the Parties’ Alliance Managers to the JSC for resolution in accordance with Section 3.2(c).

  • Exchange of Information. The Partnership Parties shall cooperate to exchange information through the JDC and otherwise as reasonably requested by the other Partnership Party with respect to Development and regulatory activities with the Products in the Field in the U.S. Territory during the U.S. Territory Term conducted by each Partnership Party and their Affiliates (on behalf of such Partnership Party) and, in the case of KKC, its Sublicensees. Kura and KKJP shall cooperate to exchange information through the JDC and otherwise as reasonably requested by the other Party with respect to Development and regulatory activities with the Products in the Territory conducted by each Party and their Affiliates and, in the case of KKJP, its Sublicensees. Such exchange shall include summaries of information relating to such Development and registration activities of each Party, including all Clinical Trials of any Product and IND and Regulatory Approval Application filings for all indications for any Product. Upon Kura’s written request, KKUS and KKJP shall provide any additional data or information requested by Kura to the extent necessary to comply with the terms and conditions of the Michigan License and the MSK License.

  • Joint Commercialization Committee.

  • Formation. In accordance with Section 3.2(b)(xix), the Parties shall establish a subcommittee to review and oversee the Commercialization of the Products in the Territory and to coordinate the Parties’ activities under this Agreement with respect to the Commercialization of the Products in the U.S. Territory in accordance with the U.S. Territory Commercialization Plan and Budget (the “JCC”) within [***] days after the Effective Date all in accordance with this Section 3.4. The JCC shall be comprised of six (6) representatives (three (3) from each Party or such other equal number of representatives as agreed by the Parties in writing) to the JCC, each of which shall have sufficient seniority within such Party and relevant expertise to make decisions arising within the scope of the JCC’s responsibilities. Each Party may replace its JCC representatives upon written notice to the other Party. A member of the JCC may also be a member of the JSC or any other Committee if so desired by the Party who appoints such member.

  • Role. In addition to its overall responsibility for review, oversight and coordination of the Parties’ Commercialization activities with respect to Products under this Agreement, the JCC shall:

  • provide a forum for the discussion of the Parties’ Commercialization activities with respect to the Products in Field in the Territory;

  • review and discuss the overall strategy for Commercialization of Products in the Field in the U.S. Territory during the U.S. Territory Term and in the Ex-U.S. Territory in the Ex-U.S. Territory Term;

  • develop a global pricing strategy for the Products in the Field throughout the Territory (the “Global Pricing Strategy”) and approve for submission to the JSC;

  • develop a global branding strategy for the Products in the Field throughout the Territory (the “Global Branding Strategy”) and approve for submission to the JSC;

  • develop a global strategy for each Product Developed and Commercialized in the Field throughout the Territory under this Agreement (the “Global Product Strategy”) and approve for submission to the JSC;

  • review and discuss the promotion and marketing strategy of the Products in the Field in the U.S. Territory during the U.S. Territory Term and in the Ex-U.S. Territory in the Ex-U.S. Territory Term;

  • review and discuss sales force structure, size and call plans for the U.S. Territory to support the U.S. Territory Commercialization Plan and Budget;

  • discuss and approve addenda to the U.S. Territory Commercialization Plan and Budget setting forth the allocation of FTE responsibilities;

  • review and discuss market access strategy, distribution and patient services, pricing and contracting guardrails for the Products in the Field in the U.S. Territory during the U.S. Territory Term;

  • in accordance with and subject to Section 5.2, review and discuss and approve for submission to the JSC the U.S. Territory Commercialization Plan and Budget, including any amendments thereto;

  • review and update commercial forecasts and finances at least quarterly to assess actual and anticipated spend in light of the then-current U.S. Territory Commercialization Plan and Budget;

  • review, discuss and coordinate the Commercialization activities of the Partnership Parties with respect to Products in the Field in the U.S. Territory during the U.S. Territory Term, including pre-launch and post-launch activities, any Phase 4 Clinical Trials, Non-Interventional Studies and Post-Marketing Commitment, and any Co-Promotion activities of the Parties;

  • allocate primary responsibility as between the Partnership Parties for tasks relating to Commercialization of Products in the Field in the U.S. Territory during the U.S. Territory Term;

  • review, discuss, coordinate and approve the Partnership Parties’ Medical Affairs activities for Products in the Field in the U.S. Territory during the U.S. Territory Term (the responsibility for which may be delegated by the JCC to a subcommittee of the JCC that is comprised of medical representatives of the Parties);

  • address obligations under applicable Data Protection Laws which includes allocating the Parties’ respective roles as a Controller or Joint Controller of Personal Data;

  • review and discuss the Commercialization activities of KKJP and its Affiliates, Sublicensees and Distributors in the Ex-U.S. Territory with respect to Products; and

  • perform such other functions as expressly set forth in this Agreement or allocated to it by the Parties’ written agreement.

  • Decision-Making. All decisions of the JCC shall be made by unanimous vote, with Kura’s representatives collectively having one (1) vote and KKC’s representatives collectively having one (1) vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JCC, the JCC cannot reach a decision as to such matter within [***] days after such matter was brought to the JCC for resolution, such matter shall be referred by the Parties’ Alliance Managers to the JSC for resolution in accordance with Section 3.2(c).

  • Exchange of Information. The Partnership Parties shall cooperate to exchange information through the JCC and otherwise as reasonably requested by the other Partnership Party with respect to Commercialization activities with the Products conducted by each Party and their Affiliates (on behalf of such Partnership Party) in the U.S. Territory during the U.S. Territory Term. Kura and KKJP shall cooperate to exchange information through the JCC and otherwise as reasonably requested by the other Party with respect to Commercialization activities with the Products conducted by each Party and their Affiliates and, in the case of KKJP, its Sublicensees. Such exchange shall include summaries of information relating to Commercialization, promotion and marketing, and where applicable, a global brand. Upon Kura’s written request, KKJP shall provide any additional data or information requested by Kura to the extent necessary to comply with the terms and conditions of the Michigan License and the MSK License.

  • Joint Manufacturing Committee.

  • Formation. In accordance with Section 3.2(b)(xix), the Parties shall establish a subcommittee to review and oversee the Manufacturing of the Products in the Territory and to coordinate the Parties’ activities under this Agreement with respect to Manufacture of the Products (“JMC”) within [***] days after the Effective Date all in accordance with this Section 3.5. The JMC shall be comprised of four (4) representatives (two (2) from each Party or such other equal number of representatives as agreed by the Parties in writing) to the JMC, each of which shall have sufficient seniority within such Party and relevant expertise to make decisions arising within the scope of the JMC’s responsibilities. Each Party may replace its JMC representatives upon written notice to the other Party. A member of the JMC may also be a member of the JSC or any other Committee if so desired by the Party who appoints such member.

  • Role. In addition to its overall responsibilities for review, coordination and oversight of the Parties’ Manufacturing activities with respect to Products under this Agreement, the JMC shall:

  • review and discuss the overall strategy for Manufacture and supply of Products in the Field in the U.S. Territory and Ex-U.S. Territory;

  • after the first Product receives first Regulatory Approval from the FDA in the Field, review and approve any changes to the process and quality specifications for the Compound and Products in the Field; and

  • approve the Manufacturing Technology Transfer plan and oversee the activities thereunder.

  • Decision-Making. All decisions of the JMC shall be made by unanimous vote, with Kura’s representatives collectively having one (1) vote and KKC’s

  • representatives collectively having one (1) vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JMC, the JMC cannot reach a decision as to such matter within [***] days after such matter was brought to the JMC for resolution, such matter shall be referred by the Parties’ Alliance Managers to the JSC for resolution in accordance with Section 3.2(c).

  • Exchange of Information. The Partnership Parties shall cooperate to exchange information through the JMC and otherwise as reasonably requested by the other Partnership Party with respect to Manufacturing activities with the Products conducted by each Party and their Affiliates (on behalf of such Partnership Party) in the U.S. Territory during the U.S. Territory Term. Kura and KKJP shall cooperate to exchange information through the JMC and otherwise as reasonably requested by the other Party with respect to Manufacturing activities with the Products conducted by each Party and their Affiliates and, in the case of KKJP, its Sublicensees. Such exchange shall include summaries of information relating to demand and supply of Product for use in Clinical Trials. For clarity, demand and supply of commercial Product shall be exchanged in accordance with the Commercial Supply Agreement. Upon Kura’s written request, KKUS and KKJP shall provide any additional data or information requested by Kura to the extent necessary to comply with the terms and conditions of the Michigan License and the MSK License.

  • Joint Patent Committee.

  • Formation. Within [***] days after the Effective Date, the Parties shall establish a joint patent committee to oversee the patent strategy for the portfolio of Kura Product Patents and KKC Patents for the Products hereunder (the “JPC”). Unless otherwise agreed by the Parties, the JPC shall consist of an equal number of representatives of each Party. A Party may change one (1) or more of its JPC representatives from time to time in its sole discretion, effective upon written notice to the other Party of such change. A Party’s representatives to the JPC shall be such Party’s in-house intellectual property counsel or other designated person appointed by such Party (which may include a Party’s external patent counsel), and shall have authority within such Party’s organization with respect to Patent-related matters to enable such person to make decisions on behalf of the applicable Party with respect to the issues falling within the decision making authority of the JPC. The Alliance Managers will attend all meetings of the JPC as non-voting observers.

  • Role. Except as otherwise provided herein, the JPC shall:

  • coordinate and oversee the Patent Prosecution and enforcement of the Kura Product Patents and KKC Patents;

  • coordinate and oversee the filing of Extensions for the Kura Patents and KKC Patents;

  • serve as a forum for the exchange of information regarding the Patent Prosecution of Kura Product Patents or KKC Patents;

  • serve as a forum for the exchange of information regarding the enforcement of a Kura Non-Product Patent with respect to a Product Infringement and of Ziftomenib Composition Patents in accordance with Section 12.4(d), and regarding the enforcement of a Kura Patent in accordance with Section 12.4(h);

  • determine whether a decision to abandon the Patent Prosecution of a Kura Product Patent or KKC Patent, or the enforcement of a Kura Product Patent with respect to a Product Infringement, is [***];

  • serve as a forum for the exchange of information and review and discussion of intellectual property matters under this Agreement; and

  • perform such other obligations as are expressly assigned to the JPC herein (or within the JSC’s responsibilities and allocated by the JSC), or otherwise agreed by the Parties in writing.

  • Decision-Making. All decisions of the JPC shall be made by unanimous vote, with Kura’s representatives collectively having one (1) vote and KKC’s representatives collectively having one (1) vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JPC, the JPC cannot reach a decision as to such matter within [***] days after such matter was brought to the JPC for resolution, then [***].

  • Limitation of Authority. Each Committee shall only have the powers expressly assigned to it in this ARTICLE 3 and elsewhere in this Agreement and shall not have the authority to: (a) modify or amend the terms and conditions of this Agreement; (b) waive either Party’s compliance with the terms and conditions of this Agreement; (c) determine any such issue in a manner that would conflict with the express terms and conditions of this Agreement; or (d) impose any other obligations on either Party without the prior written consent of such Party.

  • Meetings. Each Committee shall hold meetings [***] (or at such frequency as mutually agreed by the Parties). Each Party may call additional ad hoc Committee meetings as the needs arise with reasonable advance notice to the other Party. Meetings of each Committee may be held in person, by audio or video teleconference. In-person Committee meetings shall be held at locations selected alternately by the Parties. Each Party shall be responsible for such Party’s expenses of participating in the Committee meetings. No action taken at any Committee meeting shall be effective unless at least one (1) representative of each Party is participating in such Committee meeting.

  • Non-Member Attendance. Each Party may from time to time invite a reasonable number of participants relevant to items on the issued agenda, in addition to its representatives, to attend a Committee meeting in a non‑voting capacity; provided that if either Party intends to have any Third Party (including any consultant) attend such a meeting, such Party shall provide prior written notice to the other Party. Such Party shall also ensure that such Third Party is bound by confidentiality and non-use obligations consistent with the terms of this Agreement.

  • Discontinuation of Participation on a Committee. Each Committee shall continue to exist until the Parties mutually agreeing in writing to disband the Committee. In the event a Party has provided written notice as referred to in this Section 3.10, such affected Committee shall have no further force and effect or obligations under this Agreement but all decisions formerly made within or by such Committee shall become a decision as between the Parties.

  • Development AND REGULATORY MATTERS

  • Overview. Subject to the terms and conditions of this Agreement: (a) during the U.S. Territory Term, Kura shall lead the Development of the Compounds and the Products in the Field for the U.S. Territory (with input from KKC via the JSC and JDC), and the Parties shall Develop the Compounds and the Products in the Field in accordance with the Development Plan and Budget and (b) during the Ex-U.S. Territory Term, KKJP shall lead the Development of the Compounds and the Products in the Field for the Ex-U.S. Territory during the Ex-U.S. Territory Term in accordance with the Ex-U.S. Territory Development Plan, in each case as provided in this ARTICLE 4. For the avoidance of doubt, upon request by the other Party, each Party shall provide the other Party with necessary support for the Development of the Compounds and the Products in the Field as set forth in further detail hereunder.

  • Development Plan and Budget. All Development of the Compound and Products in the Field in the Territory under this Agreement during the U.S. Territory Term that is designed to support Regulatory Approval in the U.S. Territory and is not specific to the Ex-U.S. Territory shall be conducted by or on behalf of Kura and KKC pursuant to a comprehensive written development plan and budget (as amended in accordance with this Agreement, the “Development Plan and Budget”); [***]. The Development Plan and Budget shall include: [***]. The cost of performing the activities set forth in the Development Plan and Budget shall be shared by Kura and KKUS in accordance with Section 4.9, provided, however, that if the need for a particular U.S. Territory activities are reasonably attributable to KKC, the allocation of such Development costs as between Kura and KKC shall be discussed between the Parties. As of the Effective Date, Kura and KKC have agreed to the initial Development Plan and Budget setting forth such Development activities as of the Effective Date until the end of 2028, attached hereto as Schedule 4.2(B), pursuant to which the Parties shall pursue Development of the Collaboration Indications. Following the Effective Date, Kura and KKC shall discuss and agree on, through the JDC, addenda to the Development Plan and Budget that are specific to Clinical Trials or Development activities, which shall set forth an allocation of time by such FTEs to be spent on such activities. If the terms of any Development Plan and Budget contradict, or create any inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this Agreement shall govern. In the event that Kura wishes to conduct additional Development activities relating to the Compound and Products in the U.S. Territory to support Regulatory Approval in the U.S. Territory, in each case that is not set forth in the Development Plan and Budget, including by enrolling additional patients or conducting additional Clinical Trials (including Combination Clinical Trials), in each case that is not a Mandatory Development Activity or an Expanded Indication Trial subject to Section 4.4(c) (such Development activities, “Discretionary Development Activities”), Kura and KKC shall discuss in good faith through the JSC regarding amendments to be made to the Development Plan and Budget accordingly. [***].

  • Ex-U.S. Territory Development Plan. All Development of the Compound and Products in the Field under this Agreement during the Ex-U.S. Territory Term for the Ex-U.S. Territory for the region-specific Development activities which are not included in the Development Plan and Budget shall be conducted by or on behalf of KKJP (or any of its Affiliates or Sublicensees) pursuant to a comprehensive written development plan (as amended in accordance with this Agreement, the “Ex-U.S. Territory Development Plan”), [***]. The

  • Ex-U.S. Territory Development Plan shall include: [***]. In the event that region-specific Development activities related to chemistry, manufacturing and controls (such activities, “CMC Development Activities”) are required for the Ex-U.S. Territory, [***] will use Commercially Reasonable Efforts to conduct such region-specific CMC Development Activities upon agreement between the Parties, provided that [***] shall bear [***]% of such region-specific Development costs incurred [***] with respect to the performance of such CMC Development Activities; [***]. If the terms of any Ex-U.S. Territory Development Plan contradict, or create any inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this Agreement shall govern. Within [***] days following the Effective Date or such longer period as agreed to by the Parties, the Parties will discuss and agree to the initial Ex-U.S. Territory Development Plan. In the event that KKJP wishes to conduct additional Development activities relating to the Compound and Products in the Ex-U.S. Territory to support Regulatory Approval in the Ex-U.S. Territory, which are not set forth in the Ex-U.S. Territory Development Plan, including by enrolling additional patients or conducting additional Clinical Trials (including Combination Clinical Trials), in each case that is not an Expanded Indication Trial subject to Section 4.4(c) (such Development activities, “Ex-U.S. Discretionary Development Activities”), the Parties shall discuss in good faith through the JSC regarding amendments to be made to the Ex-U.S. Territory Development Plan accordingly. [***].

  • Updates.

  • For each Calendar Year, Kura (with respect to the Development Plan and Budget during the U.S. Territory Term) or KKJP (with respect to the Ex-U.S. Territory Development Plan during the Ex-U.S. Territory Term) shall prepare updates and amendments, as appropriate, to the Development Plan and Budget and the Ex-U.S. Territory Development Plan, as applicable, on an annual basis (no later than [***] of the preceding Calendar Year), or more frequently as the Parties agree, provided that each of the Development Plan and Budget and Ex-U.S. Territory Development Plan shall always include the Development of Products for all Collaboration Indications. Such updated or amended Development Plan and Budget or Ex-U.S. Territory Development Plan shall cover the next [***] Calendar Years (but at minimum [***] in all cases, and additional periods as reasonably determined by the Parties). The relevant Parties shall submit all such updates and amendments to the JDC for review and discussion by the JDC and further approval by the JSC. Once approved by the JSC, each such updated or amended Development Plan and Budget or the Ex-U.S. Territory Development Plan, as the case may be, shall replace the prior Development Plan and Budget or the Ex-U.S. Territory Development Plan (as applicable). In addition, if KKUS exercises the Field Expansion Option, the Development Plan and Budget shall be amended to include the Development of Products for solid tumors and any Solid Tumor Indications that the Parties agree to Develop, including an amendment of the budget set forth therein with respect to such Development.

  • Notwithstanding anything to the contrary in this Agreement, [***].

  • If a Party desires to add an additional Global Clinical Trial or Local Clinical Trial that is (i) a Clinical Trial for an additional indication in the Field (each, an “Expanded Indication Trial”) (for clarity, an Expanded Indication Trial shall exclude any Mandatory Development Activities, Combination Clinical Trial, or Marketing Trial), (ii) a Combination Clinical Trial, or (iii) a Marketing Trial, such Party shall provide written notice to the JSC setting forth in reasonable detail the design of such Expanded Indication Trial, Combination Clinical Trial or Marketing Trial, as applicable, and the applicable budget

  • therefor. The JSC shall review, discuss and determine whether to approve such Expanded Indication Trial, Combination Clinical Trial or Marketing Trial, subject to Sections 3.2(c) and Section 5.2.

  • With respect to any Combination Clinical Trial or Marketing Trial, the Parties shall discuss, through the JSC, any amendment of the Development Plan and Budget or U.S. Territory Commercialization Plan and Budget, as applicable, to include any Combination Clinical Trial or Marketing Trial that is a Global Clinical Trial or Local Clinical Trial in the U.S. Territory, and if the Partnership Parties agree on such amendment of the Development Plan and Budget or U.S. Territory Commercialization Plan and Budget, as applicable, then the Partnership Parties shall share (A) the Development Costs for the conduct of such Combination Clinical Trial in accordance with the amended Development Plan and Budget pursuant to Section 4.9; and (B) the Medical Affairs Costs for the conduct of such Marketing Trial in accordance with the amended U.S. Territory Commercialization Plan and Budget pursuant to Section 5.2. For clarity, if the Parties do not agree on such amendment, then [***].

  • With respect to any Expanded Indication Trial, the Parties shall discuss, through the JSC, any amendment of the Development Plan and Budget to include any Expanded Indication Trial that is a Global Clinical Trial or Local Clinical Trial in the U.S. Territory, and if the Partnership Parties agree on such amendment of the Development Plan and Budget, then the Partnership Parties shall share the Development Costs for the conduct of such Expanded Indication Trial in accordance with the amended Development Plan and Budget pursuant to Section 4.9.

  • Subject to Section 3.2(c)(iii)(2), if the JSC approves the conduct of any Expanded Indication Trial that is a Global Clinical Trial or Local Clinical Trial in the U.S. Territory, but the Parties cannot agree on the amendment of the Development Plan and Budget with respect thereto, then [***] (the “Developing Party”) [***].

  • Subject to exercise of the Opt-In Right by KKUS or KKJP pursuant to Section 4.4(c)(v), if [***] is the Developing Party, (A) any data generated by or on behalf of [***] in the course of conducting such Expanded Indication Trial [***] shall be [***], (B) [***], and (C) if [***] obtains Regulatory Approval based on the results of such Expanded Indication Trial, then [***]. Subject to [***] Section 4.4(c)(v), if [***] is the Developing Party: (A) the Parties shall agree on, through the JSC, any activities to be conducted by [***], (D) if Regulatory Approval is obtained based on the results of such Expanded Indication Trial, then [***] and (E) the licenses granted to [***] under this Agreement by [***] shall be deemed to be expanded to cover such additional indication in the Expanded Indication Trial (including as necessary for the Development and Commercialization of the Product with respect to the additional indication). [***].

  • If Kura is the Developing Party and KKUS desires to share Net Sales of the Product based on Regulatory Approval for such Product based on the results of any Expanded Indication Trial, or if KKJP subsequently desires to use and/or reference the Kura Expanded Indication Trial Data for Regulatory Approval of any Product in the Ex-U.S. Territory, as applicable, KKUS or KKJP, as applicable, shall provide written notice to Kura. If KKUS is the Developing Party, and Kura desires to share Net Sales of the Product based on Regulatory Approval for such Product based on the results of any Expanded Indication Trial and include the KKUS Expanded Indication Trial Data within the licenses granted to Kura under Section 2.4(a), Kura shall provide written notice to KKUS or KKJP. The applicable

  • Developing Party hereby grants the non-Developing Party the right to make a one-time, non-refundable and non-creditable payment (“Opt-In Fee”) (provided that in case of subsection (2) below, [***] to obtain the applicable rights set forth in this Section 4.4(c)(v) (the “Opt-In Right”):

  • if the Expanded Indication Trial is a proof-of-concept Clinical Trial and not a Pivotal Clinical Trial, an amount equal to [***] percent ([***]%) of [***] costs actually incurred by the Developing Party in connection with, or reasonably allocable to, the conduct of such Expanded Indication Trial following notice provided by the Developing Party as set forth in Section 4.4(c) until the date the Opt-In Fee is paid; or

  • if the Expanded Indication Trial is a Pivotal Clinical Trial, an amount equal to [***] percent ([***]%) of [***] actually incurred by the Developing Party in connection with, or reasonably allocable to, the conduct of such Expanded Indication Trial following notice provided by the Developing Party as set forth in Section 4.4(c) until the date the Opt-In Fee is paid.

[***].

  • Conduct of Development Activities.

  • U.S. Territory. Subject to Section 4.7, Kura shall lead the Development of the Compound and Products in the Field in the U.S. Territory during the U.S. Territory Term. Unless the Parties agree in writing upon an alternate allocation of responsibility, Kura and KKC shall have the rights and obligations with respect to the operational responsibilities under each Development Plan and Budget set forth in this Section 4.5, provided, however, that if the need for a particular U.S. Territory activities are reasonably attributable to KKC, the allocation of such Development costs as between Kura and KKC shall be discussed between the Parties. For each Global Clinical Trial and Local Clinical Trial for the U.S. Territory identified in the Development Plan and Budget, unless agreed otherwise by the Parties, except as provided in Section 4.4(b), as between the Parties, Kura shall be the sponsor of such Clinical Trial [***]. Without limiting the foregoing, Kura shall keep KKC reasonably updated throughout the U.S. Territory Term regarding material developments regarding the Development of the Compound and Products in the Field in the U.S. Territory and the conduct of Global Clinical Trial and Local Clinical Trials for the U.S. Territory. KKC shall have the right to attend and participate in key study meetings, including advisory boards, consultants’ meetings, investigator meetings, data safety monitoring board meetings, and meetings where data analysis and interpretation or changes to the Development Plan and Budget will be discussed and discussions on any significant issue that arises regarding the conduct or execution of the Development Plan and Budget. At the request of Kura, KKC shall provide Kura with necessary support, such as providing necessary Know-How, data or information Controlled by KKC for Kura to conduct such Development in the U.S. Territory, [***].

  • Ex-U.S. Territory. KKJP shall be responsible for the Development of the Compound and Products in the Field for the Ex-U.S. Territory during the Ex-U.S. Territory Term, including bearing all costs in connection therewith, and KKJP shall conduct Development activities for the Compound and Products assigned to it in accordance with the then-approved Ex-U.S. Territory Development Plan (including all associated timelines and the budget included therein); [***]. At the request of KKJP, Kura shall provide KKJP with necessary support, such as providing necessary Know-How, data or information Controlled by Kura (and, with respect to any other Know-How, data or information owned or controlled by

  • Kura’s CMO, using Commercially Reasonable Efforts to cause such CMOs to provide KKJP with such Know-How, data or information) for KKJP to conduct such Development in the Ex-U.S. Territory, in each case at KKJP’s cost. For clarity, subject to Section 4.4(b), [***]. KKJP shall keep Kura reasonably updated throughout the Ex-U.S. Territory Term regarding material developments regarding the Development of the Compound and Products in the Field in the Ex-U.S. Territory and the conduct of Local Clinical Trials for the Ex-U.S. Territory.

  • Safety Reporting. The Parties will enter into a pharmacovigilance agreement with respect to Products (as amended in accordance with its terms, the “Pharmacovigilance Agreement”) within [***] days of the Effective Date (or such later date as mutually agreed by the Parties) to govern the establishment and maintenance of a global safety database inclusive of Adverse Events and safety reporting of Clinical Trials conducted by the Parties under the Development Plan and Budget and by KKC under the Ex-U.S. Territory Development Plan, as well as Adverse Events from post-marketing/commercial experience in their respective Territories. [***].

  • Conduct of Regulatory Activities.

  • General. The Development Plan and Budget shall set forth the regulatory strategy for seeking Regulatory Approval of the Products in the Field globally, and the Ex-U.S. Territory Development Plan shall set forth the regulatory strategy for seeking Regulatory Approval of the Products in the Ex-U.S. Territory and shall be consistent with the global strategy set forth in the Development Plan and Budget. The Parties intend to and shall cooperate to maximize any Regulatory Exclusivity for the Products in the Territory to the extent permitted by Applicable Law.

  • Regulatory Responsibilities. Kura shall lead all regulatory activities necessary to obtain and maintain Regulatory Approval for the Products in the Field in the U.S. Territory and shall reasonably consider KKUS’s comments in good faith. Kura shall be solely responsible for preparing and filing all Regulatory Submissions, shall be the holder of all Regulatory Submissions and Regulatory Approvals and will have primary operational responsibility for interactions with Regulatory Authorities, including taking the lead role at all meetings with Regulatory Authorities, in each case in the Field in the U.S. Territory, subject to the right of KKUS to participate in such activities and provide input, which Kura will consider in good faith. KKJP shall have the sole authority to conduct all regulatory activities necessary to obtain and maintain Regulatory Approval for the Products in the Field in the Ex-U.S. Territory. KKJP shall be responsible for preparing and filing all Regulatory Submissions, shall be the holder of all Regulatory Submissions and Regulatory Approvals and will have primary operational responsibility for interactions with Regulatory Authorities, including taking the lead role at all meetings with Regulatory Authorities, in each case in the Field in the Ex-U.S. Territory, subject to the right of Kura to participate in such activities and provide input, which KKJP will consider in good faith. Subject to Section 4.7(d), the right of participation covers all regulatory activities, including development of regulatory strategy and review of Regulatory Submissions, attendance at all meetings with Regulatory Authorities that may potentially impact the Development of the Compound or Products hereunder or registration package for a particular Product hereunder, and review of outcomes of such meetings. Without limiting the foregoing, each Party shall reasonably cooperate with the other Party in connection with any activities or information that may be required by the other Party to obtain and maintain Regulatory Approvals for the Products in the Field for such other Party’s respective Territory [***].

  • Regulatory Authority Inspections. If a Regulatory Authority desires to conduct an inspection of a Party, its Affiliates, or its or their Subcontractors (including CMOs) relating to the Compounds or Products (or if such an inspection by a Regulatory Authority is required for the other Party to obtain Regulatory Approvals in the other Party’s territory), the audited Party shall promptly (no later than [***] days) notify the other Party thereof. Each Party shall permit Regulatory Authorities to conduct inspections or audits of: (i) it and its Affiliates and (ii) to the extent applicable as set forth under the applicable Quality Agreement, any other relevant agreement with its Subcontractors, or under ARTICLE 7, its or their Subcontractors (including CMOs) relating to the Compounds or Products (provided that, in the event that such inspections or audits are not permitted, such Party shall use Commercially Reasonable Efforts to obtain necessary consents to permit such inspections or audits). Unless prohibited by Applicable Law, each Party shall permit the other Party to attend and observe the aforementioned inspections or audits upon reasonable prior written notice (with respect to an audit of the first Party’s Subcontractor, to the extent applicable as set forth under the applicable Quality Agreement, any other relevant agreement with the first Party’s Subcontractors, or under ARTICLE 7; [***]. Each Party shall provide the other Party with a copy (or detailed written report) of any findings of a Regulatory Authority following any such regulatory audit or inspection that are communicated to the first Party by such Regulatory Authority and corresponding proposed responses, in each case, related to the Compounds or Products. In addition, in the event any such inspection could reasonably be expected to have an impact on the patient safety, efficacy or conduct of Clinical Trials of the Products, each Party shall, no later than [***] Business Days after the date of the receipt of any report or correspondence from the Regulatory Authority, provide to the other Party copies of the relevant inspection report or correspondence, to the extent applicable as set forth under the applicable Quality Agreement, any other relevant agreement with such Party’s Subcontractors, or under ARTICLE 7; [***]. Each Party will reasonably cooperate with the other Party in the preparation of any response to Regulatory Authorities and any corrective action plans. In the event that any Regulatory Authority desires to conduct an inspection or audit of a Party relating to the Compounds or Products, such as any pre-approval inspection, the other Party shall fully cooperate with such Party upon request in responding to such audit or inspection, including attending such audit or inspection if so requested by such Party, [***].

  • Review of Regulatory Submissions. Each Party shall notify the other Party of all Regulatory Submissions that it intends to make for Products in the Field in the U.S. Territory (for Kura) and in the Ex-U.S. Territory (for KKC) and shall provide such other Party with a copy (which may be wholly or partly in electronic form) of such Regulatory Submissions translated into English. The other Party shall have a period of (i) [***] days to review and comment on Regulatory Approval Applications, or (ii) [***] days to review and comment on other Regulatory Submissions (in each case, unless an earlier response is required by such applicable Regulatory Authority, in which case the Parties shall work in good faith to provide a response in such timeframe), and the submitting Party shall consider in good faith any such comments. Each Party shall provide the other Party reasonable advance notice of any scheduled meeting with any Regulatory Authority in its territory with respect to Products in the Field, and such other Party shall have the right to participate in any such meeting with the FDA or other applicable Regulatory Authority, to the extent permitted by Applicable Laws. Each Party shall also promptly furnish the other Party with copies of all material correspondence to or from, and minutes of material meetings with, any Regulatory Authority relating to Development of such Product in the Field.

  • Right of Reference.

  • KKJP Grant. KKJP hereby grants to Kura the right of reference to all Regulatory Submissions pertaining to the Products in the Field in the Territory submitted by or on behalf of KKJP or any of its Affiliates (and all data contained or referenced therein), with the right to grant further rights of reference to Kura’s licensees with respect to Compound and Products in the Territory. Kura and its Affiliates (and any licensee to whom it may grant a further right of reference) may use the right of reference to KKJP’s Regulatory Submissions in the Field and Territory solely for [***].

  • Kura Grant. Kura hereby grants to KKC the right of reference to all Regulatory Submissions pertaining to the Products in the Field submitted by or on behalf of Kura or its Affiliates or licensees in the U.S. Territory (to the extent included in the definition of Kura Know-How) (and all data contained or referenced therein), as to the Kura Know-How contained therein, with the right to grant further rights of reference to Sublicensees. KKC and its Affiliates (and any Sublicensee to whom it may grant a further right of reference) may use such right of reference to Kura’s Regulatory Submissions in the Field and in their respective Territory solely for [***].

  • Development Cost Sharing.

  • Development Costs. KKUS shall be responsible for fifty percent (50%) and Kura shall be responsible for fifty percent (50%) of all Shared Development Costs. KKJP shall be responsible for one hundred percent (100%) of Ex-U.S. Territory Development Costs. [***] neither KKUS nor Kura shall be permitted to recover Shared Development Costs in excess [***] percent ([***]%) of the amount allocated to such Party’s Development activities for such Calendar Year under the budget in the Development Plan and Budget [***]. For clarity, (i) Kura shall solely bear and be responsible for one hundred percent (100%) of the cost of the Excluded Development Activities and the Kura-Specific Development Activities and (ii) the Developing Party shall solely bear and be responsible for one hundred percent (100%) of the cost of the Expanded Indication Trial not included in the Development Plan and Budget. To the extent that Kura or KKUS incur any costs that would otherwise be considered a cost of any Excluded Development Activity, but such cost exceeds the costs set forth in the initial Development Plan and Budget, such cost shall be considered a Shared Development Cost under the updated Development Plan and Budget.

  • Development Cost Reconciliation.

  • Within [***] days after the end of each Calendar Quarter during the Calendar Years 2025 through 2028 [***], KKUS shall provide Kura with a written report of KKUS’s good faith estimate of the Development Costs incurred by it or its Affiliates with respect to the Excluded Development Activities.

  • Within [***] days after the end of each Calendar Quarter during the Calendar Years 2025 through 2028 [***], each of Kura and KKUS shall provide the other Party with a reasonably detailed written report of the Development Costs incurred by it with respect to the Excluded Development Activities.

  • Within [***] days after the end of each Calendar Quarter during [***] KKUS shall provide Kura with a written report of KKUS’s good faith estimate of the Shared Development Costs incurred by it or its Affiliates. Within [***] days after the end of

  • each Calendar Quarter during [***] each of Kura and KKUS shall provide the other Party with a reasonably detailed written report of any Shared Development Costs in sufficient detail to permit the other Party to reasonably determine whether such costs were incurred in accordance with this Agreement, and such other information related thereto reasonably requested by the other Party; provided that, for clarity, [***]. Within [***] days after the end of each Calendar Quarter, Kura shall prepare a balancing statement for Shared Development Costs reconciling amounts due to be reimbursed to each of Kura or KKUS (such amounts to be reimbursed to KKUS to include, [***]. Promptly upon the preparation of such balancing statement, an invoice shall be prepared by Kura or KKUS, as applicable, to the extent the net amount of such reconciliation for Shared Development Costs is due to be reimbursed, setting forth such amount to be reimbursed, and the paying Party shall pay the undisputed portion of such invoice within [***] days after the receipt thereof. In the event of a dispute amount the amount owed as set forth in any such invoice, the Partnership Parties shall discuss in good faith, and if the Partnership Parties are unable to resolve such dispute through such discussions, such dispute shall be resolved in accordance with ARTICLE 14.

  • Diligence and Standard of Conduct.

  • Each Party shall use Commercially Reasonable Efforts to conduct the Development activities allocated to such Party in the Development Plan and Budget (including all associated timelines and the budget included therein). Each Party shall provide reasonable cooperation to the other Party in the conduct of Development activities under each Development Plan and Budget.

  • KKC shall use Commercially Reasonable Efforts to conduct the Development activities in the Ex-U.S. Territory Development Plan (including all associated timelines included therein). Without limiting the foregoing, KKC shall use Commercially Reasonable Efforts to Develop the Products in the Ex-U.S. Territory, including to conduct such Development with the objective of achieving the Ex-U.S. Development Milestone Events in the Ex-U.S. Territory.

  • Each Party shall perform all Development activities in compliance with all Applicable Laws, including good scientific and clinical practices under the Applicable Laws of the country in which such activities are conducted.

  • Development Reports. The status, progress and results of each Partnership Party’s Development activities conducted in the U.S. Territory during the U.S. Territory Term and KKJP’s Development activities conducted in the Ex-U.S. Territory during the Ex-U.S. Territory Term pursuant to this Agreement shall be discussed at meetings of the JDC. [***]. In addition, each of Kura, KKJP and KKUS (with respect to the activities under the Development Plan and Budget and in the Ex-U.S. Territory, as applicable) shall make available to the other Party such additional information about its Development activities with respect to the Compound and Products in the Field in the Territory as may be reasonably requested by the KKJP, KKUS or Kura from time to time, including any information requested by Kura necessary to comply with the terms and conditions of the Michigan License or MSK License. All updates and reports provided by a Party pursuant to this Section 4.11 shall be the Confidential Information of such Party.

  • Records. Each Party (with respect to the activities under the Development Plan and Budget during the U.S. Territory Term) and KKJP (with respect to activities in the Ex-U.S. Territory during the Ex-U.S. Territory Term), shall maintain appropriate records in either

  • tangible or electronic form of all significant Development, Manufacture [***], regulatory or Commercialization activities with respect to Products, in each case in accordance with its usual documentation and record retention practices. Each Party shall maintain such records during the Term and thereafter for a period of at least the longer of [***] years or such longer period as required by Applicable Law. Such records shall be in sufficient detail to properly reflect, in a good scientific manner, all significant work done, and the results of studies and trials undertaken and, further, shall be at a level of detail appropriate for patent and regulatory purposes. Each Party shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines. Upon a Party’s reasonable request, the other Party shall, and shall cause its Affiliates and, in the case of KKC, Sublicensees, to provide to the first Party copies of and access to such records (including access to relevant databases, if any) of Development, packaging or labeling, Manufacture (in the case of KKC, after the Manufacturing Technology Transfer), regulatory and Commercialization activities to the extent necessary for the conduct of activities for which the requesting Party is responsible under this Agreement, including for regulatory and patent purposes. All records shall be maintained (and each Party shall cause its Sublicensees and Subcontractors to maintain) in accordance with the record retention practices and periods required under Applicable Law. To the extent consistent with Applicable Law and without limitation to each Party’s rights under this Agreement, each Party shall retain original copies of all records (including raw data) retained pursuant to this Section 4.12, and may only destroy such copies thereof after first notifying the other Party in writing and giving the other Party reasonably sufficient time to take over such original copies. All such records, reports, information and data of a Party provided to the other Party shall be the Confidential Information of the providing Party.

  • Notification of Threatened Action. Each Party shall within [***] notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by any Third Party, which would reasonably be expected to affect the safety or efficacy claims of any Product or the continued marketing of any Product. Upon receipt of such information, the Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action with respect to the Territory.

  • Product Withdrawals and Recalls.

  • U.S. Territory. If any Regulatory Authority (i) threatens, initiates or advises any action to remove any Product from the market in the Field in the U.S. Territory or (ii) requires or advises either Partnership Party or its Affiliates to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in the Field in the U.S. Territory, then KKUS or Kura, as applicable, shall notify the other Partnership Party of such event within [***] Business Days (or sooner if required by Applicable Laws) after such Partnership Party becomes aware of the action, threat, advice or requirement (as applicable). The JSC will discuss and attempt to agree upon whether to recall or withdraw a Product in the Field in the U.S. Territory; provided, however, that if the Parties fail to agree within an appropriate time period, [***]. Any recall expenses with respect to Products within the U.S. Territory shall be treated as Shared Commercial Costs except to the extent that the recall or withdrawal is attributable to the negligence or willful misconduct of a Partnership Party in which event (A) such Partnership Party shall bear such costs for which it is responsible and (B) such costs shall not be included in Shared Commercial Costs. Kura shall indemnify KKUS and its Affiliates for any Losses incurred by KKUS or its Affiliates in connection with any Claims to the extent arising from Kura’s decision not to recall or withdraw a Product in the Field in the U.S.

  • Territory notwithstanding KKUS’s or its Affiliates’ request to recall or withdraw such Product in the Field in the U.S. Territory.

  • Ex-U.S. Territory. If any Regulatory Authority (i) threatens, initiates or advises any action to remove any Product from the market in the Field in the Ex-U.S. Territory or (ii) requires or advises a Party or its Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in the Field in the Ex-U.S. Territory, then KKC or Kura, as applicable, shall notify the other Party of such event within [***] Business Days (or sooner if required by Applicable Laws) after such Party becomes aware of the action, threat, advice or requirement (as applicable). The JSC will discuss and attempt to agree upon whether to recall or withdraw a Product in the Field in the Ex-U.S. Territory; provided, however, that if the Parties fail to agree within an appropriate time period, [***]. KKC shall be responsible, at its sole expense, for conducting any recalls or taking such other necessary remedial action in the Ex-U.S. Territory [***]. KKC shall indemnify Kura and its Affiliates for any Losses incurred by Kura or its Affiliates in connection with any Claims to the extent arising from KKC’s decision not to recall or withdraw a Product in the Field in the Ex-U.S. Territory notwithstanding Kura’s or its Affiliates’ request to recall or withdraw such Product in the Field in the Ex-U.S. Territory.

  • Notification to MSK. If KKC, as applicable, is the subject of a demand, notice, inquiry, or inspection report by a Governmental Authority in relation to any Product in the Field that (i) [***], (ii) [***], (iii) [***], or (iv) [***], then KKC shall notify Kura without delay and provide to Kura all information necessary to satisfy its obligation under the MSK License.

  • Development of Next-Gen Compounds. For clarity, as between the Parties, Kura shall retain the sole right to Develop, Manufacture, Commercialize and otherwise Exploit Next-Gen Compounds and products containing any Next-Gen Compound (excluding, for clarity, the Product), subject to Section 2.7(c). Notwithstanding the foregoing, [***].

  • U.S. Territory Commercialization

  • Commercialization in the U.S. Territory. Subject to the remainder of this ARTICLE 5, and any applicable Co-Promotion Agreement between the Partnership Parties, Kura shall have the sole right and responsibility for (a) Commercializing the Products in the Field in the U.S. Territory during the U.S. Territory Term, including [***]; and (b) all decisions for all Commercialization activities relating to the Products in the U.S. Territory, including negotiations with relevant governmental authorities or agencies and managed care organizations regarding price and reimbursement status.

  • U.S. Territory Commercialization Plan and Budget. All Commercialization of the Products in the Field in the U.S. Territory under this Agreement during the U.S. Territory Term shall be conducted by or on behalf of Kura and KKC pursuant to a comprehensive written commercialization plan and budget (as updated from time to time, a “U.S. Territory Commercialization Plan and Budget”). The U.S. Territory Commercialization Plan and Budget will include: [***] (such budget included in the U.S. Territory Commercialization Plan and Budget, as updated from time to time, the “Commercial Budget”). Within [***] days following the Effective Date, Kura and KKC will discuss and agree on the initial U.S. Territory Commercialization Plan and Budget. As of the Effective Date, Kura and KKC have agreed to

  • an initial startup budget for Commercialization activities for the initial [***] day period, as set forth in Schedule 5.2, which shall be effective until the initial U.S. Territory Commercialization Plan and Budget is agreed to by Kura and KKC. Kura shall use Commercially Reasonable Efforts to Commercialize the Products in the U.S. Territory in accordance with the U.S. Territory Commercialization Plan and Budget, as such U.S. Territory Commercialization Plan and Budget may be updated or amended in accordance with Section 5.3, provided that if [***] desires to increase its Commercialization efforts beyond the scope of activities set forth in the U.S. Territory Commercialization Plan and Budget, or to conduct any Medical Affairs activities (including Marketing Trials) (“Discretionary Commercialization or Medical Affairs Activities”), then [***] shall have the right to conduct such Discretionary Commercialization or Medical Affairs Activities at its cost (provided that, [***]). KKC shall use Commercially Reasonable Efforts to perform all activities allocated to it in the U.S. Territory in accordance with the U.S. Territory Commercialization Plan and Budget. If the terms of any U.S. Territory Commercialization Plan and Budget contradict, or create any inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this Agreement shall govern. In addition, the Partnership Parties shall discuss and agree on, through the JCC, addenda to the U.S. Territory Commercialization Plan and Budget, which shall set forth an allocation of time by the Partnership Party’s FTEs to be spent on such activities.

  • Amendments to U.S. Territory Commercialization Plan and Budget. Kura shall update the U.S. Territory Commercialization Plan and Budget [***] and the JCC will review and discuss and approve for submission to the JSC, and the JSC will review, discuss and determine whether to approve, such updates. The JCC shall provide an updated U.S. Territory Commercialization Plan and Budget for each Product [***]. In addition, the JCC shall prepare [***] and provide to the JSC for approval an updated U.S. Territory Commercialization Plan and Budget. Such amended U.S. Territory Commercialization Plan and Budget shall cover the next Calendar Year and the applicable Commercial Budget shall appropriately itemize the costs separately for each Product. The JCC may prepare amendments to the U.S. Territory Commercialization Plan and Budget from time to time during the Calendar Year in order to reflect changes in such U.S. Territory Commercialization Plan and Budget for such Calendar Year. JSC approval of each U.S. Territory Commercialization Plan and Budget, or any amendment thereto shall not be required except where the total aggregate Commercial Budget for a Calendar Year included in such updated U.S. Territory Commercialization Plan and Budget exceeds the total aggregate Commercial Budget for such Calendar Year in the then-current U.S. Territory Commercialization Plan and Budget by more than [***] percent ([***]%). Any amended or updated U.S. Territory Commercialization Plan and Budget shall become effective on the date approved by the JSC (or such other date as the JSC shall specify, or where applicable, when the Executive Officers so approve).

  • Commercialization Reports. Kura shall keep the JCC reasonably informed regarding the progress and results of Commercialization activities for Products in the U.S. Territory, [***].

  • Co-Promotion by KKC. KKC shall have the right and responsibility to Co-Promote each Product set forth in the U.S. Territory Commercialization Plan and Budget in the U.S. Territory in accordance with an agreed Co-Promotion Agreement. With respect to each Product, no later than [***] months prior to the Anticipated Approval Date for such Product, KKC shall provide written notice to Kura and elect a percentage of Detailing for such Product in the U.S. Territory, which percentage in each Co-Promotion Agreement in the U.S. Territory shall be no less than [***] percent ([***]%) and shall not exceed [***] percent ([***]%) of all

  • Details of such Product in the U.S. Territory for any applicable period. Within [***] days following the Effective Date, the Partnership Parties shall discuss in good faith and agree on a co-promotion agreement with respect to Products, which agreement shall be consistent with the principles set forth in Schedule 5.5 and shall include such terms and conditions as are customary for agreements of such type as agreed by the Partnership Parties (each as amended from time to time, a “Co-Promotion Agreement”). If the terms of the Co-Promotion Agreement contradict, or create any inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this Agreement shall govern. [***]. Except for the conduct of Detailing pursuant to a Co-Promotion Agreement with respect to a Product in the U.S. Territory, KKC and its Affiliates shall not market, promote or otherwise Commercialize any Product in the U.S. Territory.

  • Breaches by Co-Promotion Personnel. If either Party becomes aware of a failure to comply with Applicable Law or the terms of this Agreement by any member of such Party’s contractors or other personnel employed as part of its sales force or medical liaisons (collectively, “Co-Promotion Personnel”), such Party shall promptly, but no later than [***] days after it becomes aware, notify the other Party of such violation and, as promptly as possible thereafter, notify the other Party of the steps it has taken or intends to take to remediate such violation. If either Party has a reasonable basis for believing any member of the other Party’s Co-Promotion Personnel has violated any Applicable Laws, or failed to comply with this Agreement, then such Party may notify the other Party of the alleged violation and the other Party shall promptly investigate the matter and, if the allegation turns out to be true, such Party shall take the appropriate remedial action. Subject to the foregoing, each Party shall be solely responsible for taking any disciplinary actions in connection with the performance of such Party’s Co-Promotion Personnel. If, at any time, either Party has any other compliance-related concerns regarding the performance of any of Co-Promotion Personnel, such Party shall notify the other Party of such concerns in writing and Kura and KKC shall discuss and use good faith efforts resolve such matters.

  • Independent Co-Promotion Personnel. Each Party acknowledges and agrees that all of the members of the its Co-Promotion Personnel are employees or contractors of such Party or its Affiliates and are not, and are not intended to be treated as, employees or contractors of the other Party or any of its Affiliates, and that such individuals are not, and are not intended to be, eligible to participate in any benefits programs or in any “employee benefit plans” (as such term is defined in section 3(3) of the Employee Retirement Income Security Act of 1974, as amended) that are sponsored by the other Party or any of its Affiliates or that are offered from time to time by the other Party or its Affiliates to their own employees. All matters of compensation, benefits and other terms of employment for any member of each Party’s Co-Promotion Personnel shall be solely a matter between such Party and such individual. Neither Party shall be responsible to the other Party or to any member of the other Party’s Co-Promotion Personnel for any compensation, expense reimbursements or benefits (including vacation and holiday remuneration, healthcare coverage or insurance, life insurance, severance or termination of employment benefits, pension or profit-sharing benefits and disability benefits), payroll-related taxes or withholdings, or any governmental charges or benefits (including unemployment and disability insurance contributions or benefits and workmen’s compensation contributions or benefits) that may be imposed upon or be related to the performance by the other Party or such individuals of this Agreement, all of which shall be the sole responsibility of the other Party, even if it is subsequently determined by any Governmental Authority that any such individual may be an employee or a common law employee of the such Party or any of its Affiliates or is otherwise entitled to such payments and benefits.

  • Compliant Purpose. Neither Party shall be required to perform any obligation under this Agreement or in the U.S. Territory Commercialization Plan and Budget, or use any promotional materials or otherwise engage in any activity, [***], that such obligation, use of promotional materials or other activity (a) violates any Applicable Law, or (b) violates a written corporate policy of such Party (provided that no corporate policy should be drafted or maintained in a manner to defeat or frustrate the other Party from receiving the benefits to which it is entitled under the Agreement). Each Party shall promptly notify the other Party if and when it formulates such a belief and the Parties shall discuss, in good faith, how best to alter the relevant obligation, promotional material or other activity so that it does not have the effect described in item (a) or (b) above.

  • Diligence. Each Partnership Party shall use Commercially Reasonable Efforts to carry out the tasks assigned to it under the U.S. Territory Commercialization Plan and Budget in compliance with all Applicable Laws.

  • Ex-U.S. Territory COMMERCIALIZATION

  • Overview. The Parties agree that the Commercialization of Products in the Field in the Ex-U.S. Territory during the Ex-U.S. Territory Term will be conducted as provided in this ARTICLE 6 under the oversight of the JCC and the JSC. KKJP shall have the sole right and the sole operational and financial responsibility for Commercializing Products in the Ex-U.S. Territory during the Ex-U.S. Territory Term in accordance with this Agreement and as provided in this ARTICLE 6. [***].

  • Ex-U.S. Territory Commercialization Plan. KKJP shall Commercialize Products in the Field in the Ex-U.S. Territory pursuant to the Ex-U.S. Territory Commercialization Plan, [***].

  • Commercialization Costs. KKJP shall be solely responsible for one hundred percent (100%) of all costs and expenses incurred by or on behalf of KKJP and its Affiliates in the Commercialization of Products in the Field in the Ex-U.S. Territory.

  • Sales and Distribution. KKJP, itself or through its Affiliates, shall be solely responsible for handling all returns, recalls, order processing, invoicing and collection, distribution, and receivables for Products in the Ex-U.S. Territory, [***].

  • Commercialization Reports. KKJP shall keep the JCC reasonably informed regarding the progress and results of Commercialization activities for the Compound and Products in the Ex-U.S. Territory, including an annual review of results versus plans. Without limiting the foregoing, KKJP shall provide all such information to the JCC as is reasonably necessary for Kura to comply with its annual reporting obligations following First Commercial Sale under the MSK License, as more fully described in [***] the MSK License.

  • Promotion. KKJP, itself or through its Affiliates or Sublicensees, shall be solely responsible for promotion and the conduct of medical support and patient advocacy activities with respect to Products in the Field in the Ex-U.S. Territory.

  • Diligence. KKJP shall use Commercially Reasonable Efforts to Commercialize at least one (1) Product in each country in the Ex-U.S. Territory after obtaining Regulatory Approval therefor in such country.

  • MANUFACTURING

  • Kura’s Manufacturing Responsibilities.

  • Subject to the terms of this ARTICLE 7, Kura shall be solely responsible (itself or through its Affiliate or CMO) for the Manufacture of the Products for Development and Commercialization by the Partnership Parties, KKJP and their Affiliates and KKJP’s Sublicensees in the Territory. Kura shall manufacture the Products for use in the U.S. Territory in accordance with the requirements of the Bayh-Dole Act solely to the extent applicable to Kura’s Manufacture of the Products. Kura shall provide the Product in accordance with the applicable Quality Agreement, Clinical Supply Agreement or the Commercial Supply Agreement. For the delivery of the Product in the Ex-U.S. Territory, [***]. If the Parties identify any necessary changes to the manufacturing process or specifications applicable to the Manufacture of Product by Kura’s CMO that are required by KKJP for the Ex-U.S. Territory, then on a country-by-country basis, [***].

  • Kura and KKJP (with respect to the Ex-U.S. Territory) shall enter into a clinical supply agreement, which shall define supply conditions of the Product, Compound, placebo, reference standard or other related materials which shall be used for KKJP’s Development activities within the Ex-U.S. Territory within [***] days following the Effective Date or such longer period as agreed by the applicable Partnership Parties or Parties (as amended from time to time, the “Clinical Supply Agreement”). The Clinical Supply Agreement would set forth terms including, but not limited to, [***]. The shelf life for such initial supply of the clinical Product shall be at least [***] years from receipt by KKJP. Quantities of an initial supply of the Product from Kura to KKJP for the Development shall be agreed in Schedule 7.1(b).

  • Kura and KKUS may also enter into a clinical supply agreement, which shall define supply conditions of the Product, Compound, placebo, reference standard or other related materials which shall be used for KKUS’s Development activities as part of a Global Clinical Trial for which KKUS shall be the sponsor as agreed upon by the Parties under the Development Plan and Budget (as amended from time to time, the “Global Clinical Supply Agreement”). The Global Clinical Supply Agreement would set forth terms including, but not limited to, delivery terms, supply price, and shelf life.

  • Kura and KKJP shall enter into a supply agreement for the Products or Compound for Commercialization in Ex-U.S. Territory (the “Commercial Supply Agreement”, and together with the Clinical Supply Agreement and the Global Clinical Supply Agreement, the “Supply Agreement”). The Commercial Supply Agreement shall define terms including, but not limited to delivery terms [***].

  • In the event of any issues arising during manufacturing at Kura’s CMO, Kura shall promptly provide written notice to KKC and shall use Commercially Reasonable Efforts to resolve these issues. [***].

  • In connection with each Supply Agreement, the applicable parties to the respective Supply Agreements shall enter into quality agreements (e.g., a clinical quality agreement (“Clinical Quality Agreement”) and a commercial quality agreement (“Commercial Quality Agreement”), or a single quality agreement as may be agreed upon by

  • the Parties) governing quality-related aspects of Manufacture and supply of Products (the Clinical Quality Agreement and the Commercial Quality Agreement, collectively, or, in the alternative, if a single quality agreement is entered into, such agreement, in each case as amended from time to time, the “Quality Agreement”). The Clinical Quality Agreement shall be agreed by Kura and KKJP within [***] days of the Effective Date. If the terms of the Supply Agreement or Quality Agreement contradict, or create any inconsistencies or ambiguities with, the terms of this Agreement, then [***].

  • Kura shall fully cooperate with KKC in complying with the requirements of the Bayh-Dole Act, including requesting waivers where KKC determines to do so, to the extent such requirements are applicable.

  • [***].

  • Each of the Supply Agreements, and the Quality Agreements shall be consistent with Kura’s agreements with its applicable CMOs, provided that upon KKC’s request to amend any terms of such agreement to the extent applicable to the Manufacture and supply of Product to KKC, Kura shall use Commercially Reasonable Efforts to amend the applicable terms of Kura’s agreements with the applicable CMOs, [***].

  • Records Retention. Kura will, and will ensure that its Affiliates, and its and their Subcontractors, including the CMOs, will, keep and maintain in good scientific manner complete, appropriate and accurate records in sufficient detail to verify compliance with its obligations under this Agreement. Without limiting Kura’s information security obligations under this Agreement, Kura will maintain, [***], all records in its possession, custody or control in commercially reasonable secure and suitable facilities and ensure that such facilities (and the records stored at such facilities) are (in the context of a regulatory audit permitted under this Agreement) reasonably accessible to KKC (or its appointed auditor) to comply with Applicable Laws or requirements by Regulatory Authorities in the Ex-U.S. Territory.

  • Manufacturing Technology Transfer. At any time during the Ex-U.S. Territory Term, if KKC notifies Kura in writing that it wishes to Manufacture the Products for Commercialization in the Ex-U.S. Territory, at KKC’s sole cost, Kura shall, (a) transfer all Know-How within the Kura Manufacturing Technology to a CMO designated by KKC and reasonably acceptable to Kura (such CMO, including KKC’s Affiliates a “KKC CMO”), (b) provide any and all necessary assistance to such KKC CMO in connection with the obligation set forth in the foregoing subclause (a), and (c) coordinate with Kura’s Subcontractor to supply materials to KKC that are necessary for the Manufacture of the Product but which KKC is unable to itself obtain (clauses (a), (b) and (c), the “Manufacturing Technology Transfer”). If KKC requires access to any Confidential Information of any CMO of Kura in order to comply with Applicable Law in the Ex-U.S. Territory and Kura’s existing agreement with its CMO does not permit such disclosure to KKC, [***]. For the purpose of avoidance doubt, KKC shall be entitled to have Manufacturing Technology Transfer of the Product, which shall include [***]. The Parties shall agree in good faith on a written Manufacturing Technology Transfer plan defining the scope, timeline and conditions of the Manufacturing Technology Transfer. In the event that KKC reasonably and in good faith determines [***] the documents and data previously delivered in order to remedy the identified deficiencies. [***].

  • KKC’s Manufacturing Responsibilities. Following the completion of the activities set forth in the Manufacturing Technology Transfer plan, including KKC’s obtaining of relevant Regulatory Approvals necessary for such Manufacture, KKC shall be solely

  • responsible (itself or through its Affiliate or CMO) for the Manufacture of the Products for Development and Commercialization in the Ex-U.S. Territory pursuant to this Agreement, including responsibility for obtaining all licenses or other authorizations for the importation of all quantities of the Products.

  • Allocation of Manufacturing Costs in the Territory.

  • [***] the Fully Burdened Manufacturing Costs for Manufacturing the Products for the U.S. Territory that are included in Shared Development Costs or Shared Commercial Costs.

  • The supply price for the Compound, the Products and the placebo for the purpose of Development activities that are specific for the Ex-U.S. Territory (including preclinical studies and CMC development) shall be [***] percent ([***]%) of the Fully Burdened Manufacturing Costs therefor, and the supply price for the Compound and Products for Commercialization for the Ex-U.S. Territory shall be [***] percent ([***]%) of the Fully Burdened Manufacturing Costs therefor.

  • Payments and Milestones

  • Upfront Payments.

  • In partial consideration of the licenses and rights granted by Kura to KKUS hereunder for the U.S. Territory, KKUS shall pay to Kura a one-time, irrevocable, non-refundable, non-creditable amount of [***] Million U.S. Dollars ($[***]) (the “KKUS Upfront Payment”) on or before [***] after KKUS’s receipt of an invoice for such amount from Kura which invoice shall be sent from Kura to KKUS on or after the Effective Date.

  • In partial consideration of the licenses and rights granted by Kura to KKJP hereunder for the Ex-U.S. Territory, KKJP shall pay to Kura a one-time, irrevocable, non-refundable, non-creditable amount of [***] Million U.S. Dollars ($[***]) (the “KKJP Upfront Payment”) on or before [***] after KKJP’s receipt of an invoice for such amount from Kura which invoice shall be sent from Kura to KKJP on or after the Effective Date.

  • Development Milestone Payments in the U.S. Territory.

  • When a Product first achieves the events set forth below (each such event, a “U.S. Development Milestone Event”), Kura shall submit an invoice to KKUS for the corresponding milestone payment, and KKUS shall pay to Kura the following one-time, irrevocable, non-refundable, non-creditable milestone payments (each such payment, a “U.S. Development Milestone Payment”) within [***] days after the receipt of an invoice, which invoice shall be sent from Kura to KKUS on or after the achievement of each applicable U.S. Development Milestone Event.

U.S. Development Milestone Events U.S. Development Milestone Payments
[***] $[***]
U.S. Development Milestone Events U.S. Development Milestone Payments
--- ---
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
Total U.S. Development Milestone Payments $[***]
  • For the avoidance of doubt, (i) each U.S. Development Milestone Payment shall be payable on the first occurrence of the corresponding U.S. Development Milestone Event for a Product, and (ii) no U.S. Development Milestone Payments would be due for subsequent or repeated achievements of the same U.S. Development Milestone Event, whether by the same Product or a different Product.

  • With respect to each indication and country or region, if any milestone event in the table above has not been achieved at the time of achievement of a milestone event having a higher number than a skipped milestone event, then each such skipped milestone event shall be deemed achieved at the time of achievement of the higher number milestone event for the same indication and in the same country or region.

  • Development Milestone Payments in the Ex-U.S. Territory.

  • When a Product first achieves the events set forth below (each such event, an “Ex-U.S. Development Milestone Event”), KKJP shall notify Kura in writing within [***] Business Days upon achievement of each Ex-U.S. Development Milestone Event. After receipt of such notice, Kura shall submit an invoice to KKJP for the corresponding milestone payment, and KKJP shall pay to Kura the following one-time, irrevocable, non-refundable, non-creditable milestone payments (each such payment, an “Ex-U.S. Development Milestone Payment”) within [***] days after the receipt of such invoice.

Ex-U.S. Development Milestone Events Ex-U.S. Development Milestone Payments
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
Total Ex.-U.S. Development Milestone Payments $[***]
  • For the avoidance of doubt, (i) each Ex-U.S. Development Milestone Payment shall be payable on the first occurrence of the corresponding Ex-U.S. Development Milestone Event for a Product, and (ii) no Ex-U.S. Development Milestone Payments would be due for subsequent or repeated achievements of the same Ex-U.S. Development Milestone Event, whether by the same Product or a different Product.

  • With respect to each indication and country or region, if any milestone event in the table above has not been achieved at the time of achievement of a milestone event having a higher number than a skipped milestone event, then each such skipped milestone event shall be deemed achieved at the time of achievement of the higher number milestone event for the same indication and in the same country or region.

  • Additional Development Milestones for Solid Tumors in the U.S. Territory.

  • If KKUS exercises the Field Expansion Option pursuant to Section 2.8(b), when a Product first achieves the events set forth below for a Solid Tumor Indication (each such event, a “U.S. Solid Tumor Development Milestone Event”), Kura shall submit

  • an invoice to KKUS with respect to the corresponding milestone payment, and KKUS shall pay to Kura the following one-time, irrevocable, non-refundable, non-creditable milestone payments (each, a “U.S. Solid Tumor Development Milestone Payment”) within [***] days after the receipt of such invoice.

U.S. Solid Tumor Development Milestone Events U.S. Solid Tumor Development Milestone Payments
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
Total U.S. Solid Tumor Development Milestone Payments $[***]
  • For the avoidance of doubt, (i) each U.S. Solid Tumor Development Milestone Payment in this Section 8.4 shall be payable on the first occurrence of the corresponding U.S. Solid Tumor Development Milestone Event for a Product, and (ii) no U.S. Solid Tumor Development Milestone Payments would be due for subsequent or repeated achievements of the same U.S. Solid Tumor Development Milestone Event, whether by the same Product or a different Product.
  • With respect to each indication and country or region, if any milestone event in the table above has not been achieved at the time of achievement of a milestone event having a higher number than a skipped milestone event, then each such skipped milestone event shall be deemed achieved at the time of achievement of the higher number milestone event for the same indication and in the same country or region.
  • Additional Development Milestones for Solid Tumors in the Ex-U.S. Territory.
  • If KKJP exercises the Field Expansion Option pursuant to Section 2.8(b), when a Product first achieves the events set forth below for a Solid Tumor Indication (each such event, an “Ex-U.S. Solid Tumor Development Milestone Event”), KKJP shall notify Kura in writing within [***] Business Days. After receipt of such notice, Kura shall submit an invoice to KKJP for the corresponding milestone payment, and KKJP shall pay to Kura the following one-time, irrevocable, non-refundable, non-creditable milestone payments (each, an “Ex-U.S. Solid Tumor Development Milestone Payment”) within [***] days after the receipt of such invoice.
Ex-U.S. Solid Tumor Development Milestone Events Ex-U.S. Solid Tumor Development Milestone Payments
[***] $[***]
[***] $[***]
[***] $[***]
[***] $[***]
Total Ex-U.S. Solid Tumor Development Milestone Payments $[***]
  • For the avoidance of doubt, (i) each Ex-U.S. Solid Tumor Development Milestone Payment in this Section 8.5 shall be payable on the first occurrence of the corresponding Ex-U.S. Solid Tumor Development Milestone Event for a Product, and (ii) no Ex-U.S. Solid Tumor Development Milestone Payments would be due for subsequent or repeated achievements of the same Ex-U.S. Solid Tumor Development Milestone Event, whether by the same Product or a different Product.
  • With respect to each indication and country or region, if any milestone event in the table above has not been achieved at the time of achievement of a milestone event having a higher number than a skipped milestone event, then each such skipped milestone event shall be deemed achieved at the time of achievement of the higher number milestone event for the same indication and in the same country or region.
  • Commercial Milestone Payments in the Ex-U.S. Territory.
  • KKJP shall pay to Kura the following one-time, irrevocable, non-refundable, non-creditable milestone payments (each such payment, an “Ex-U.S. Commercial Milestone Payment”). KKJP shall notify Kura in writing within [***] days after the end of the Calendar Quarter in which the aggregate annual Net Sales of all Products in the Ex-U.S. Territory in a Calendar Year first achieves or exceeds the total annual threshold set forth below (each such event, an “Ex-U.S. Commercial Milestone Event”). Kura shall submit an invoice to KKJP for the corresponding milestone payment, and KKJP shall make the payment within [***] days after the receipt of such invoice.
Ex-U.S. Commercial Milestone Event Ex-U.S. Commercial Milestone Payment
Annual Net Sales of all Products in the Ex-U.S. Territory first equal or exceed $[***] $[***]
Annual Net Sales of all Products in the Ex-U.S. Territory first equal or exceed $[***] $[***]
Annual Net Sales of all Products in the Ex-U.S. Territory first equal or exceed $[***] $[***]
Ex-U.S. Commercial Milestone Event Ex-U.S. Commercial Milestone Payment
--- ---
Annual Net Sales of all Products in the Ex-U.S. Territory first equal or exceed $[***] $[***]
Maximum Ex-U.S. Commercial Milestone Payments $[***]
  • For the avoidance of doubt (i) each Ex-U.S. Commercial Milestone Payment shall be payable on the first occurrence of the corresponding Ex-U.S. Commercial Milestone Event, and (ii) no Ex-U.S. Commercial Milestone Payments would be due for subsequent or repeated achievements of the same Ex-U.S. Commercial Milestone Event. If aggregate annual Net Sales of all Products in the Ex-U.S. Territory in a given Calendar Year equal or exceed more than one (1) applicable threshold, then all corresponding Ex-U.S. Commercial Milestone Payments that have not been previously paid shall be payable.
  • Royalties in the Ex-U.S. Territory.
  • Royalty Payment. During the Royalty Term, KKJP shall pay to Kura tiered royalties as calculated by multiplying the applicable royalty rate set forth in the table below by the corresponding amount of incremental, aggregated Net Sales of Products in the Ex-U.S. Territory in a Calendar Year, on a Product-by-Product basis (a “Royalty Payment”). The tiered royalty rates on Net Sales shall be as set forth below:
For that portion of annual Net Sales of a Product in the Ex-U.S. Territory in a Calendar Year Royalty Rate
Less than or equal to $[***] [***]%
Greater than $[***]and less than or equal to $[***] [***]%
Greater than $[***]and less than or equal to $[***] [***]%
Greater than $[***] [***]%
  • Royalty Term. The Royalty Payments payable under this Section 8.7 shall be payable on a Product-by-Product and country-by-country basis in the Ex-U.S. Territory from the first occurrence of Net Sales of the applicable Product in such country in the Ex-U.S. Territory until the latest of: (i) the date of expiration of the last-to-expire Valid Claim in such country that Covers the composition of matter, pharmaceutical composition, Manufacture, use or sale of such Product (or the Compound contained therein) in such country that such Product is Manufactured or sold; (ii) the expiration of the Regulatory Exclusivity for such Product in such country; and (iii) ten (10) years after the date of the First Commercial Sale of such Product in such country (the “Royalty Term”).

  • Royalty Reductions.

  • During the Royalty Term for a Product in a country in the Ex-U.S. Territory, subject to Section 8.7(c)(iv), the royalty rate applicable to Net Sales of such Product in such country shall be reduced by [***] percent ([***]%) after the expiration of the last-to-expire Valid Claim in such country.

  • During the Royalty Term for a Product in a country in the Ex-U.S. Territory, subject to Section 8.7(c)(iv), the royalty rate applicable to Net Sales of such Product in such country shall be reduced by [***] percent ([***]%) starting from the Calendar Quarter in which Generic Competition with respect to such Product occurs in such country.

  • If KKJP reasonably determines in good faith after advice of counsel that it is necessary for KKJP to obtain a license under any Patents owned or controlled by a Third Party in order to manufacture or Commercialize the Product in the Field in the Ex-U.S. Territory and enters into such a license in accordance with Section 2.12(b), then subject to Section 8.7(c)(iv), KKJP shall have the right to deduct, from the Royalty Payment that would otherwise have been due pursuant to this Section 8.7, an amount equal to [***] percent ([***]%) of the royalties paid by KKJP to such Third Party pursuant to such license on account of the sale of such Product in the Field in the Ex-U.S. Territory; provided that prior to entering into such license, KKJP shall provide Kura with the opportunity to review such Patents owned or controlled by such Third Party. Within [***] days following the execution of any such Third Party license, KKJP shall provide Kura with a true and complete copy of such Third Party license.

  • In no event shall the operation of Section 8.7(c)(i) through 8.7(c)(iii), individually or in combination, reduce the royalties payable by KKJP to Kura with respect to the Net Sales of any Product in any country in the Ex-U.S. Territory in any Calendar Quarter to an amount less than [***] percent ([***]%) of the amount that would otherwise have been due pursuant to Section 8.7(a) with respect to such Net Sales; provided that any such reduction not taken fully as a result of the application of this section may be carried forward and applied against future royalties [***].

  • Royalty Reports. Following the First Commercial Sale of a Product for which Royalty Payments are due pursuant to this Section 8.7, and continuing for so long as any Royalty Payments are due hereunder:

  • KKJP shall, within [***] days after the end of each Calendar Quarter, provide Kura with a good faith estimate of the Royalty Payments due for such Calendar Quarter.

  • KKJP shall, within [***] days after the end of each Calendar Quarter, provide Kura with a royalty report (in a template agreed to by the Parties) showing, on a country-by-country basis in the Ex-U.S. Territory:

  • the Net Sales of each Product sold by KKJP, its Affiliates and Sublicensees during such Calendar Quarter reporting period;

  • the Royalty Payments in U.S. Dollars which shall have accrued hereunder with respect to such Net Sales, with supporting calculations showing the applicable royalty rate applied and any royalty reduction taken; and

  • the rate of exchange with supporting calculations, determined in accordance with Section 8.9(b), used by KKJP in determining the amount of U.S. Dollars payable hereunder.

  • Royalty Invoicing. After the receipt of each royalty report provided by KKJP under Section 8.7(d) above, Kura shall issue to KKJP an invoice for the amount of

  • Royalty Payment set forth therein. KKJP shall pay to Kura the Royalty Payment for each Calendar Quarter within [***] days after the receipt of the invoice from Kura. If no Royalty Payments is due for any Calendar Quarter following commencement of the reporting obligation, KKJP shall so report.

  • U.S. Territory Profit-or-Loss.

  • Profit-or-Loss Share. During the Share Period for a Product, the Partnership Parties shall share in Profit-or-Loss for such Product according to each such Partnership Party’s Share Percentage; provided, however, that with respect to any Shared Commercial Costs incurred prior to the Share Period, the Parties shall share such costs in accordance with the below provisions; provided that the Shared Commercial Revenue shall be considered zero during such period.

  • Profit-or-Loss Statement. The reporting and determination of the Profit-or-Loss shall be governed by a statement (the “Profit-or-Loss Statement”) to be prepared by Kura and submitted to KKUS. Such Profit-or-Loss Statement shall be prepared and delivered consistent with the provisions of this Section 8.8 and all other relevant terms and conditions of this Agreement.

  • Reporting on Shared Commercial Revenue. Kura shall report to KKUS and to the JCC, Shared Commercial Revenue in the following manner:

  • Within [***] days after the end of each Calendar Quarter, Kura shall report Shared Commercial Revenue for each Product in the U.S. Territory for the preceding Calendar Quarter; and

  • Within [***] days after the end of the fourth Calendar Quarter of each Calendar Year, Kura shall report Shared Commercial Revenue for each Product accrued in the U.S. Territory for the preceding Calendar Year.

  • Forecasts

  • Kura shall provide a long-term forecast of Shared Commercial Revenue covering at least next [***] years [***].

  • Kura shall provide a short-term forecast of Shared Commercial Revenue covering the [***].

  • Shared Commercial Costs.

  • Each Partnership Party shall provide the other Party and the JCC with a report of such Party’s Shared Commercial Costs incurred (each, a “Shared Commercial Cost Report”) setting forth such Party’s Shared Commercial Costs and showing each specific type of cost included in the definition of Shared Commercial Costs separately and the project relating to each such cost, if applicable, in the following manner.

  • Within [***] days after the end of each Calendar Quarter, each Partnership Party shall provide its good faith estimate of the Shared Commercial Costs incurred by such Partnership Party in the U.S. Territory for the preceding Calendar Quarter. Within [***] days after the end of each Calendar Quarter, each Partnership Party shall provide a Shared Commercial Cost Report setting forth an itemized list, with reasonable details and

  • amounts for each such item (including, with respect to Kura, any royalties on Net Sales paid by Kura under the Michigan License or under the MSK License), such Party’s Shared Commercial Costs in the U.S. Territory for the preceding Calendar Quarter.

  • Within [***] days after the end of the fourth Calendar Quarter of each Calendar Year, each Partnership Party shall provide its good faith estimate of the Shared Commercial Costs incurred by such Partnership Party in the U.S. Territory for the preceding Calendar Year. Within [***] days after the end of the fourth Calendar Quarter of each Calendar Year, each Partnership Party shall provide a Shared Commercial Cost Report setting forth such Party’s Shared Commercial Costs in the U.S. Territory for the preceding Calendar Year.

  • Each such Shared Commercial Cost Report shall be delivered in a mutually agreed electronic format to the extent possible or in hard copy form. Each Shared Commercial Cost Report shall be treated as Confidential Information of the reporting Partnership Party and, subject to Applicable Laws, shall not be disclosed to Third Parties without such Partnership Party’s prior written approval or direction; provided, however, that either Partnership Party may disclose such information as permitted by ARTICLE 9. Notwithstanding the foregoing, nothing contained in this Agreement shall prevent a Partnership Party from using the data in any Shared Commercial Cost Reports in connection with its compliance with its price reporting obligations under Applicable Laws (provided, however, that each Partnership Party shall use commercially reasonable efforts to protect Confidential Information of the other Partnership Party).

  • The Profit-or-Loss Statement shall include Shared Commercial Costs; provided that total actual Shared Commercial Costs for the year to date have not exceeded the Shared Commercial Costs within the then-current Commercial Budget for such Calendar Year by more than [***] percent ([***]%) for the Calendar Year to date. If actual Shared Commercial Costs exceeded Shared Commercial Costs within the then-current Commercial Budget for such Calendar Year by more than [***] percent ([***]%) for the Calendar Year to date [***].

  • The actual accumulated amount of Shared Commercial Costs that exceeded the then-current Commercial Budget for any year by more than [***] percent ([***]%) and are borne [***].

  • The Shared Commercial Costs included in the Profit-or-Loss Statement and submitted by each of Kura or KKUS, as applicable, shall not be duplicative of one another or of other expenses already deducted from Net Sales due to earlier submissions by that Partnership Party, and all such Shared Commercial Costs shall be incurred pursuant to and consistent with the U.S. Territory Commercialization Plan and Budget.

  • [***].

  • Determination of Profit-or-Loss. Within [***] days following the end of each of the first three (3) Calendar Quarters and [***] days following the end of the fourth Calendar Quarter, Kura shall determine and allocate Profit-or‑Loss, according to the Profit‑or‑Loss Statement to be approved by the JCC. Reconciling payments under this Section 8.8(f) shall be made within [***] days of receipt of the Profit-or-Loss Statement. In the event of a dispute amount the amount owed as set forth in any Profit-or-Loss Statement, the Partnership Parties shall discuss in good faith, and if the Partnership Parties are unable to

  • resolve such dispute through such discussions, such dispute shall be resolved in accordance with ARTICLE 14.

  • Payment.

  • Mode of Payment. All payments to be made under this Agreement shall be made in U.S. Dollars and shall be paid by electronic transfer in immediately available funds to such bank account in the United States as is designated in writing by the Party entitled to payment. All payments shall be free and clear of any transfer fees or charges. [***].

  • Currency Exchange Rate. The rate of exchange to be used in computing the amount of currency equivalent in U.S. Dollars for calculating Net Sales in a Calendar Quarter (for purposes of both the royalty calculation and whether a Net Sales milestone has been achieved) shall be made in a manner consistent with KKC’s standard conversion procedures and methodology, in each case consistently applied in accordance with Accounting Standards.

  • Payment Timeline. Except as otherwise provided in this Agreement, all payments to be made by one Party to the other Party under this Agreement shall be due within [***] days following such Party’s receipt of an invoice from the other Party. For clarity, any invoice provided by Kura under this Agreement that are substantially in the form of the invoice attached hereto as Schedule 8.9(c), shall be deemed acceptable to KKUS or KKJP, as applicable.

  • Audits.

  • Record Retention. Each Party shall keep, and shall require its Affiliates and, in the case of KKC, its Sublicensees to keep (all in accordance with the Accounting Standards), for a period not less than [***] years from the end of the Calendar Year to which they pertain, complete and accurate records (including all Shared Commercial Cost records) in sufficient detail to determine the payments due and costs incurred under this Agreement, including the Royalty Payments and Profit-or-Loss payments.

  • Auditing of Records. Upon the written request of a Party, the Party or its Affiliate that is obligated to make a payment or has incurred costs used in calculating any payment under this Agreement (the “Audited Party”) shall permit, and shall cause its Affiliates and, in the case of KKC as the Audited Party, its Sublicensees to permit, an independent certified public accounting firm of nationally recognized standing selected by the other Party (the “Auditing Party”) and reasonably acceptable to the Audited Party, at the Auditing Party’s expense, to have access during normal business hours to such records of the Audited Party or its Affiliates as may be reasonably necessary to verify the accuracy of the payments due and costs incurred hereunder for any Calendar Year ending not more than [***] years prior to the date of such request. These rights with respect to any Calendar Year shall terminate [***] years after the end of any such Calendar Year and shall be limited to once each Calendar Year (provided that the foregoing frequency limit shall not apply if the Auditing Party has cause). The Auditing Party shall provide the Audited Party with a copy of the accounting firm’s written report within [***] days of the Auditing Party’s receipt of such report. If such accounting firm concludes that there was an underpayment of any payment due to the Auditing Party or an overstatement of the costs incurred by the Audited Party, then the Audited Party shall pay the amount of the payment due or excess costs reported within [***] days of the date the Auditing Party delivers to the Audited Party such accounting firm’s written report so

  • concluding. If such accounting firm concludes that an overpayment was made, then such overpayment shall be credited against any future payment due to the Auditing Party hereunder (if there is no future payment due, then the Auditing Party shall promptly refund such overpayment to the Audited Party). If such accounting firm concludes that there were costs incurred by the Audited Party in excess of those reported, then the Audited Party shall include the amount of such excess costs in the next report of such costs. The Auditing Party shall bear the full cost of such audit unless such audit discloses that the additional payment payable by the Audited Party or overstatement of costs by the Audited Party for the audited period is more than [***] percent ([***]%) of the amount otherwise paid or reported for that audited period, in which case the Audited Party shall pay the reasonable fees and expenses charged by the accounting firm unless the reason for such difference was a miscalculation on the part of the Auditing Party.

  • Confidentiality of Records. The Auditing Party shall treat all financial information subject to review under this Section 8.10 in accordance with the confidentiality provisions of ARTICLE 9, and, prior to commencing such audit, shall cause its accounting firm to enter into a confidentiality agreement with the Audited Party obligating it to treat all such financial information in confidence pursuant to such confidentiality provisions. Such accounting firm shall not disclose the Audited Party’s Confidential Information to the Auditing Party, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by the Audited Party or the amount of payments to or by the Audited Party under this Agreement.

  • Audit of Sublicensees. Each of KKUS and KKJP shall include in each relevant sublicense granted by it a provision requiring any Sublicensee to maintain records of sales of Products made pursuant to such sublicense, and to grant access to such records by an accounting firm to the same extent and under the same obligations as required of KKUS and KKJP under this Agreement. Kura shall advise KKUS or KKJP, as applicable, in advance of each audit of any such Sublicensee either by Kura or its designated auditor under the terms of such Sublicensee agreement. Kura shall provide KKUS or KKJP, as applicable, with a summary of the results received from the audit and, if KKUS or KKJP, as applicable, so requests, a copy of the audit report. The costs of such audit shall be allocated in the manner in Section 8.10(b) treating such Sublicensee as the Audited Party.

  • Interest. Each Party shall pay interest on any amounts overdue under this Agreement at a per annum rate of [***]; provided, however, that in no case shall such interest rate exceed the highest rate permitted by Applicable Laws. [***].

  • Taxes.

  • Taxes. Except as otherwise provided in this Section 8.12, each Party will pay any and all Taxes levied on account of all payments it receives under this Agreement. The Parties shall cooperate in accordance with Applicable Laws to minimize transfer, documentary, sales, use, stamp, consumption, goods and services, VAT or other similar taxes (each, an “Indirect Tax”) in connection with this Agreement.

  • Withholding Taxes. The Parties shall cooperate with one another and use reasonable efforts to avoid or reduce Tax withholdings or similar obligations in respect of the payments made hereunder. If Applicable Laws require that Taxes be withheld with respect to any payments under this Agreement (the “Withholding Taxes”), prior to making such payment the payor will: (a) timely provide a prior written notice to the payee of the amounts

  • subject to deduction or withholding, and the legal basis therefore; (b) reasonably cooperate with the payee in identifying any forms, certificates or other items that are necessary in order to reduce or eliminate such Withholding Taxes; and (c) provide the payee a reasonable opportunity to furnish such forms, certificates or other items that would reduce or eliminate such Withholding Taxes. Subject to the provisions of the Tax Appendix, in the event there is no applicable bilateral income tax treaty, or if an applicable bilateral income tax treaty does not eliminate such Withholding Taxes, the payor will: (x) deduct those Withholding Taxes from the remittable payment, (y) pay the Withholding Taxes to the proper taxing authority, and (z) send an official tax receipt or other reasonably available proof of payment of such Withholding Taxes to the payee on a reasonable and timely basis following that payment. Each Party agrees to cooperate with the other Parties in claiming refunds or exemptions from such deductions or withholdings under any relevant agreement, Applicable Law, or treaty which is in effect. The Parties shall discuss applicable mechanisms for minimizing such Withholding Taxes to the extent possible in compliance with Applicable Laws.

  • Cooperation. The Parties shall use reasonable efforts to provide any tax form that may be reasonably necessary in order to reduce or avoid Withholding Tax under an applicable bilateral income tax treaty. KKJP shall provide to Kura a valid and properly completed IRS Form W-8BEN-E and KKUS shall provide to Kura a valid and properly completed IRS Form W-9 in each case on or prior to the Effective Date. Kura shall provide to KKUS a properly completed IRS Form W-9, and shall provide to KKJP a valid Form 6166 in each case on or prior to the Effective Date.

  • Assignment. If the paying Party (or its assignee pursuant to Section 15.3) is required by Applicable Law to withhold Taxes in respect of payments made under this Agreement, and to the extent such withholding obligation arises or is increased solely as a result of any unilateral action by the paying Party or its Affiliates after the Effective Date (other than any action at the request or direction of the payee or contemplated by this Agreement), including without limitation, an assignment, transfer or other disposition of some or all of its rights and obligations under this Agreement to any Person, there is a Change of Control of the paying Party, there is a change in the entity making payments under this Agreement, a failure of the paying Party to comply with Applicable Laws or payments arise or are deemed to arise through a branch of the paying Party (each, a “Withholding Tax Action”) then, notwithstanding anything to the contrary herein, any amount payable by the paying Party or the paying Party’s assignee or transferee under this Agreement shall be increased to take into account such increased Withholding Taxes as may be necessary so that, after making all required withholdings (including any withholdings on additional amounts), the payee (or its assignee pursuant to Section 15.3) receives an amount equal to the amount that it would have received had no such Withholding Tax Action occurred and it shall be a condition precedent to any such assignment, transfer or disposal that such assignee or transferee shall assume the withholding and payment obligations as set forth in this Section 8.12.

  • Indirect Taxes. Notwithstanding anything to the contrary in this Agreement, all amounts stated herein are exclusive of Indirect Taxes. If any Indirect Taxes are chargeable in respect of any payments under this Agreement, the applicable paying Party shall pay such Indirect Taxes at the applicable rate in respect of any such payments following the receipt of a valid invoice.

  • Foreign Derived Intangible Income and Other Tax Benefit. KKC and Kura shall use commercially reasonable efforts to provide, and to cause its respective Affiliates, Subcontractors, sub-licenses, customers and applicable Third Parties to provide, any

  • information and documentation in its possession that is reasonably requested by the other Party to obtain the benefits of (i) Section 250 of the Internal Revenue Code of 1986, as amended and the applicable Treasury Regulations and/or (ii) any other relevant Tax legislation that could provide a material Tax benefit to Kura or KKC.

  • Intended Tax Treatment.

  • The Parties intend that the activities and transactions contemplated by (i) the Development Plan and Budget and the allocation hereunder of Shared Development Costs, (ii) the Commercialization and Medical Affairs activities and related activities in the U.S. Territory and the allocations hereunder of the Profit-or-Loss (including for clarity, the U.S. Territory Commercialization Plan and Budget and the allocation hereunder of Shared Commercial Costs), and (iii) any other activities identified in the Tax Appendix (or as subsequently agreed among the Parties in accordance with the provisions of the Tax Appendix) give rise to a deemed partnership for U.S. federal (and applicable state and local) income tax purposes solely between Kura and KKUS (the “Collaboration Partnership”) commencing as of the Effective Date, and that the provisions set forth in Schedule 8.13 (the “Tax Appendix”) shall govern the agreement of the Parties with respect to the U.S. federal income tax (and, to the extent relevant, applicable U.S. state and local tax) matters set forth therein, including the Partnership Parties’ agreement as to tax matters pertaining to the Collaboration Partnership.

  • The Parties intend that for U.S. federal income tax purposes that the provisions in this Agreement that constitute the Collaboration Partnership as described in clause (a), shall be treated as described in the Tax Appendix (the “Intended Tax Treatment”). The Parties agree for all applicable U.S. federal, state and local income tax purposes to report the transactions contemplated by this Agreement in a manner consistent with the Intended Tax Treatment unless otherwise required by Applicable Laws.

  • Tax Representations and Covenants.

  • KKC represents and warrants and covenants as applicable, to Kura that:

  • Neither KKJP nor KKUS is or has ever been a partner in a partnership or a deemed partnership for applicable United States federal income tax purposes that in any way involves or relates to the Products, intellectual property rights or any other matters governed by this Agreement;

  • KKUS shall be the sole KKC entity that is the economic and beneficial owner of all payments of Profit-or-Loss pursuant to Section 8.8 of this Agreement for United States federal income tax purposes;

  • KKJP and KKUS and their Affiliates will conduct any intercompany arrangements on an arm’s-length basis including without limitation the Cost Sharing Agreement pursuant to which any intellectual property or other rights deemed contributed to the Collaboration Partnership (other than intellectual property or other rights deemed contributed by Kura) shall be deemed contributed by KKUS;

  • The Cost Sharing Agreement shall be effective as of the Effective Date and complies in all respects with the requirements of Section 482 of the Code and the regulations promulgated thereunder. Pursuant to the Cost Sharing Agreement, KKUS

  • is the beneficial owner of the intellectual property rights for the U.S. Territory that are relevant to the Collaboration Partnership;

  • KKJP is a tax resident of Japan and no other jurisdiction and KKUS is a tax resident of the United States and no other jurisdiction;

  • KKC does not own any stock or securities of Kura;

  • KKC shall not transfer, sell, contribute, assign or otherwise alter the legal or beneficial ownership of the intellectual property or other economic rights deemed contributed to the Collaboration Partnership or otherwise take any action that is inconsistent with the Intended Tax Treatment or that could reasonably be expected to cause an adverse tax effect to Kura or any of its Affiliates, or adversely alter the economic position of Kura or any of its Affiliates with respect to, the Collaboration Partnership or alter the Tax Appendix, without the prior written consent of Kura; and

  • KKC shall not change the U.S. income tax classification, the tax domicile, tax residence, entity type or form or take any similar action with respect to KKUS that could change the tax classification or tax residence of KKUS (or otherwise cause KKUS to cease to be treated as a partner of the Collaboration Partnership for applicable tax purposes), and otherwise shall at all times cause KKUS to continue to be a domestic-U.S. entity that is taxable as a corporation for United States federal income tax purposes.

  • Kura represents and warrants, and covenants as applicable, to KKC that:

  • As of the Effective Date, Kura does not have any subsidiaries;

  • Kura is a tax resident of the United States and no other jurisdiction;

  • Kura has never been a partner in a partnership or a deemed partnership for applicable United States federal income tax purposes that in any way involves or relates to the Products, intellectual property rights or any other matters governed by this Agreement;

  • Kura shall not transfer, sell, contribute, assign or otherwise alter the legal or beneficial ownership of the intellectual property or other economic rights deemed contributed to the Collaboration Partnership or otherwise take any action that is inconsistent with the Intended Tax Treatment or that could reasonably be expected to cause an adverse tax effect to KKC or any of its Affiliates, or adversely alter the economic position of KKC or any of its Affiliates with respect to, the Collaboration Partnership or alter the Tax Appendix, without the prior written consent of KKUS;

  • Kura shall not change the U.S. income tax classification, the tax domicile, tax residence, entity type or form or take any similar action with respect to Kura that could change the tax classification or tax residence of Kura (or otherwise cause Kura to cease to be treated as a partner of the Collaboration Partnership for applicable tax purposes), and otherwise shall at all times cause Kura to continue to be a domestic-U.S. entity that is taxable as a corporation for United States federal income tax purposes; and

  • Kura and its Affiliates will conduct any intercompany arrangements on an arm’s-length basis.

  • Blocked Currency. If by Applicable Laws in a country in the Territory, conversion into U.S. Dollars or transfer of funds of a convertible currency to the United States becomes materially restricted, forbidden or substantially delayed, then the Party obligated to make a payment under this Agreement shall promptly notify the Party entitled to receive such payment and, thereafter, amounts accrued in such country or region under this ARTICLE 8 shall be paid to such receiving Party (or its designee) in such country or region in local currency by deposit to an escrow account in a local bank designated by such receiving Party and to the credit of such receiving Party, unless the Parties otherwise agree.

  • Confidentiality; Publication

  • Nondisclosure Obligation. During the Term and for a period of ten (10) years thereafter, the Receiving Party shall keep confidential, shall not publish, make available or otherwise disclose to any Third Party, and shall not use for any purpose, other than as expressly provided for in this Agreement or any other written agreement between the Parties, any of the Disclosing Party’s Confidential Information, without the express prior written consent of the Disclosing Party; provided that with respect to any Confidential Information that the Disclosing Party specifically identifies to the Receiving Party in writing constitutes a trade secret under Applicable Law, the obligations of non-disclosure and non-use in this Section 9.1 shall survive for so long as such Confidential Information constitutes a trade secret under Applicable Law. The Receiving Party shall exercise at least the same degree of care it would exercise to protect its own proprietary information (and in no event less than a reasonable standard of care) to maintain the confidentiality of the Disclosing Party’s Confidential Information. If the Receiving Party becomes aware of any loss or unauthorized acquisition, access, encryption, use, disclosure or other Processing of the Disclosing Party’s Confidential Information, it shall notify the Disclosing Party without undue delay.

  • Exceptions. Notwithstanding the foregoing, the confidentiality and non-use obligations under Section 9.1 shall not apply with respect to any information that the Receiving Party can show by competent written evidence:

  • was already known to the Receiving Party at the time it was disclosed to the Receiving Party by the Disclosing Party without an obligation of confidentiality and not through a prior disclosure by the Disclosing Party;

  • was or becomes generally known to the public through no act or omission of the Receiving Party in violation of the terms of this Agreement;

  • was lawfully received by the Receiving Party from a Third Party without restriction on its disclosure and without, to the reasonable knowledge of the Receiving Party, a breach by such Third Party of an obligation of confidentiality to the Disclosing Party or any other Third Party; or

  • was independently developed by the Receiving Party without use of or reference to the Confidential Information of the Disclosing Party, as demonstrated by the Receiving Party’s written records contemporaneously maintained with such development.

Any combination of features or disclosures will not be deemed to fall within the foregoing exclusions merely because individual features or disclosures are published or available to the general public or in the rightful possession of the Receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the Receiving Party.

  • Permitted Disclosures. Notwithstanding the provisions of Section 9.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:

  • exercising the Receiving Party’s rights or performing its obligations under this Agreement or any other written agreement between the Parties, provided that the Receiving Party uses efforts to secure confidential treatment of such Confidential Information at least as diligent as such Party would use to protect its own Confidential Information, but in no event less than reasonable efforts;

  • prosecuting or defending litigation as permitted by this Agreement;

  • complying with applicable court orders, Applicable Law, or the listing rules of any exchange on which the Receiving Party’s securities are traded, including under the Physician Payment Sunshine Act and related requirements (for clarity, the Parties agree that such Confidential Information may include without limitation payments, or other transfers of value, made on behalf or at the request of a Party to physicians, teaching hospitals, and other persons or entities that are the subject of Applicable Laws, and each Party further agrees to promptly respond to, and cooperate with, the reasonable requests of the other Party regarding collection of information regarding and compliance with Applicable Laws);

  • disclosure in regulatory or security filings that the Receiving Party has the right to make under this Agreement, provided that the Receiving Party uses efforts to secure confidential treatment of such Confidential Information at least as diligent as such Party would use to protect its own Confidential Information, but in no event less than reasonable efforts;

  • disclosure (i) to the Receiving Party’s Affiliates, officers, directors, employees, agents, consultants or independent contractors, including licensees, sublicensees, Subcontractors (including, in the case of KKC, KKC’s CMOs or potential CMOs), who need to know the Confidential Information in connection with exercising rights or performing obligations as contemplated by this Agreement or any other written agreement between the Parties or (ii) solely to the extent necessary to comply with its obligations under an Upstream Agreement, including in the case of Kura, to comply with its obligations under the Michigan License or MSK License, provided that, in each case of clause (i) and (ii), any such Persons to whom disclosure is made are bound by confidentiality and non-use obligations with respect to such Confidential Information consistent with those set forth herein and the Receiving Party shall remain responsible for the compliance by such Persons with such confidentiality and non-use obligations; and

  • disclosure to actual or prospective Third Party investors, collaborators or acquirors in connection with bona fide due diligence or similar investigation by such Third Parties, solely for the purpose of conducting such due diligence and evaluating or carrying out a business relationship with the disclosing Party or any of its Affiliates; provided, in each case, that any such Third Party agrees to be bound by reasonable obligations or confidentiality and

  • non-use and the Receiving Party shall remain responsible for the compliance by such Third Party with such confidentiality and non-use obligations.

Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 9.3(b) or (c), it will, except where impracticable, (i) give reasonable advance notice to the Disclosing Party of such required disclosure, (ii) use efforts to secure confidential treatment of such Confidential Information at least as diligent as the Receiving Party would use to protect its own confidential information, but in no event less than reasonable efforts, and (iii) cooperate with any lawful efforts by the Disclosing Party, at the Disclosing Party’s request and expense, to contest such disclosure, to obtain a protective order for such Confidential Information required to be disclosed, or to secure other confidential treatment of such Confidential Information. Disclosure by the Receiving Party of the Disclosing Party’s Confidential Information in accordance with any of the foregoing provisions of this Section 9.3 will not, in and of itself, cause the information so disclosed to cease to be treated as Confidential Information under this Agreement, except to the extent that, by virtue of disclosure by the Receiving Party in full compliance with this Section 9.3, such information becomes generally known or available. In any event, the Receiving Party agrees to take all reasonable action to avoid disclosure of the Disclosing Party’s Confidential Information hereunder.

  • Publications. The Parties shall jointly discuss and develop a global publication strategy for the publication of scientific papers, abstracts, meeting presentations and other disclosure of the results of the Clinical Trials (including post-approval clinical studies) carried out pursuant to this Agreement in the Field in the Territory (the “Global Publication Strategy”) (such Global Publication Strategy to be reviewed and approved by the JDC), taking into consideration (a) the Parties’ interest in publishing the results for the Compound and Products being Developed or Commercialized under this Agreement in order to obtain peer review of results and conclusions, recognition within the scientific community and to advance the state of scientific knowledge, and (b) the need to protect Confidential Information, intellectual property rights and other business interests of the Parties. Subject to the foregoing and except for disclosures permitted in accordance with Section 9.3, each Party will have the right to publish any academic, scientific, or medical publications, presentations, or data (collectively, “Publications”) for the Compounds and Products in such Party’s Territory, provided that (i) any such Publication is consistent with the Global Publication Strategy approved by the JDC and (ii) for any Publication, the publishing Party will deliver to the other Party and the JDC a copy of the proposed Publication at least [***] days prior to submission of such Publication. The reviewing Party, through the JDC, will have the right to (A) propose modifications to the publication or presentation for patent reasons, trade secret reasons or commercial implications or to remove Confidential Information of the reviewing Party or its Affiliates, and the publishing Party will remove all Confidential Information of the reviewing Party if requested by the reviewing Party and otherwise use good faith efforts to reflect such Party’s reasonable comments, or (B) request a reasonable delay in publication or presentation in order to protect patentable information. If the reviewing Party requests a delay to enable the reviewing Party to file patent applications as permitted under Section 12.3 protecting such Party’s right in such information, then the publishing Party will delay such submission or presentation for a period of [***] days (or such shorter period as may be agreed by the Parties). With respect to any proposed publications or disclosures by investigators or academic or non‑profit collaborators, such materials will be subject to review under this Section 9.4 to the extent that KKC or Kura, as the case may be, has the right and ability to do so (after using Commercially Reasonable Efforts to obtain such right and ability). All Publications relating

  • to any Product will be prepared, presented, and published in accordance with pharmaceutical industry quality standards being documented, auditable and compliant with Good Publication Practice, International Committee of Medical Journal Editors and the Global Publication Strategy.

  • Publicity; Use of Names.

  • The Parties have agreed upon the content of a joint press release that will be issued substantially in the form attached hereto as Schedule 9.5, and the Parties will coordinate the issuance of such press release promptly upon execution and delivery of this Agreement. Except to the extent already disclosed in a press release or other public communication issued in accordance with this Agreement, no public announcement concerning this Agreement, its subject matter or the transactions described herein will be made, either directly or indirectly, by either Party or its Affiliates, except as may be required by Applicable Law (including disclosure requirements of the SEC), judicial order, or stock exchange or quotation system rule without first obtaining the approval of the other Party and agreement upon the nature, text and timing of such announcement, which approval and agreement will not be unreasonably withheld or delayed. The Party desiring to make any such voluntary public announcement will provide the other Party with a written copy of the proposed announcement in reasonably sufficient time prior to public release to allow the other Party to comment upon such announcement prior to public release. In the case of press releases or other public communications required to be made by Applicable Law, judicial order or stock exchange or quotation system rule, the Party making such press release or public announcement will provide to the other Party a copy of the proposed press release or public announcement in written or electronic form upon such advance notice as is practicable under the circumstances for the purpose of allowing the notified Party to review and comment upon such press release or public announcement. Under such circumstances, the releasing Party will not be obligated to delay making any such press release or public communication beyond the time when the same is required to be made. Neither Party will be required to seek the permission of the other Party to repeat any information that has already been publicly disclosed by such Party or by the other Party, in accordance with this Section 9.5; provided that such information remains accurate as of such time and provided the frequency and form of such disclosure are reasonable.

  • Each Party may make public statements regarding this Agreement in response to questions by the press, analysts, investors or those attending industry conferences or financial analyst calls, provided that any such public statement or press release: (i) is not inconsistent with prior public disclosures or public statements made in accordance with Section 9.5 or as permitted by Section 9.3; and (ii) does not reveal (A) information regarding the terms of this Agreement that have not previously been disclosed in accordance with Section 9.5 or as permitted by Section 9.3 or (B) the other Party’s Confidential Information.

  • The Parties will coordinate in advance with each other in connection with the filing of this Agreement (including redaction of certain provisions of this Agreement) with any securities authority or with any stock exchange on which securities issued by a Party or its Affiliate are traded, and each Party will use reasonable efforts to seek confidential treatment for the terms proposed to be redacted; provided that each Party will ultimately retain control over what information to disclose to any securities authority or stock exchange, as the case may be, to the extent such Party determines, on the advice of legal counsel, that disclosure is reasonably necessary to comply with Applicable Law, including disclosure requirements of the SEC, or with the requirements of any stock exchange on which securities issued by a Party or its Affiliates are traded, and provided, further, that the Parties will use their reasonable efforts

  • to file redacted versions with any governing bodies which are consistent with redacted versions previously filed with any other governing bodies.

  • Equitable Relief. Each Party acknowledges that its breach of this ARTICLE 9 may cause irreparable harm to the other Party, which may not be reasonably or adequately compensated in damages in an action at law. By reasons thereof, each Party agrees that the other Party shall be entitled, in addition to any other remedies it may have under this Agreement or otherwise, to seek preliminary and permanent injunctive and other equitable relief to prevent or curtail any actual or threatened breach of the obligations relating to Confidential Information set forth in this ARTICLE 9 by the other Party.

  • Prior Confidentiality Agreement. As of the Effective Date, the terms of this ARTICLE 9 shall supersede any prior non-disclosure, secrecy or confidentiality agreement between the Parties (or their Affiliates) relating to the subject of this Agreement, including the Confidentiality Agreement.

  • Representations, Warranties, and Covenants

  • Representations and Warranties of Each Party. Each Party represents and warrants to the other Party as of the Effective Date that:

  • it is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including the right to grant the licenses granted by it hereunder;

  • it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder;

  • it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;

  • this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms;

  • it is not a party to any agreement that would prevent it from granting the rights granted to the other Party under this Agreement or performing its obligations under this Agreement; and

  • all consents, approvals and authorization from all Governmental Authorities or other Third Parties required to be obtained by such Party in connection with execution of this Agreement or to grant the rights licensed or purported to be licensed hereunder have been obtained.

  • Additional Representations and Warranties of Kura. Kura represents and warrants to KKC as of the Effective Date that:

  • Kura has the right under the Kura Technology to grant the licenses to KKC as purported to be granted pursuant to this Agreement;

  • Schedule 1.175 sets forth a complete and accurate list all Kura Patents Controlled by Kura as of the Effective Date (other than any Patents that are licensed to Kura by a Third Party service provider or general vendor and are not material and not necessary to the Development, Manufacture or Commercialization of a Product in the Field in the Territory), and to Kura’s knowledge, no other Patent owned or Controlled by Kura discloses or claims, generically or specifically, a Compound as of the Effective Date, [***]. To Kura’s knowledge, the claims included in any issued Kura Product Patent are valid, subsisting and in full force and effect as of the Effective Date;

  • except for the Ziftomenib Composition Patents and the MSK Patents and except as otherwise set forth on Schedule 10.2(c), Kura is the sole and exclusive owner of all of the Kura Patents existing as of the Effective Date (other than any Patents that are licensed to Kura by a Third Party service provider or general vendor and are not material and not necessary to the Development, Manufacture or Commercialization of a Product in the Field in the Territory) and is listed in the records of the appropriate U.S. or foreign governmental agencies as the sole and exclusive owner of record for each registration, grant and application included in such Kura Patents;

  • Kura has obtained all necessary consents and approvals under all agreements with Third Parties necessary to grant the licenses granted (or purported to be granted) hereunder (without any additional payment or other consideration);

  • (i) the Existing Upstream Agreements are set forth on Schedule 1.98; (ii) a true, correct and complete copy of each Existing Upstream Agreement has been provided to KKC, redacted solely with respect to confidential or other commercially sensitive information not pertinent to KKC’s rights hereunder; (iii) the licenses granted to Kura under the Existing Upstream Agreements are in full force and effect; (iv) Kura has not received any written notice of breach from the applicable Third Party to such Existing Upstream Agreement, and is not aware of any material breach by the applicable Third Party to the Existing Upstream Agreements; (v) Kura’s performance of its obligations under this Agreement will not breach or otherwise violate any of Kura’s or its Affiliates’ obligations under the Existing Upstream Agreements or the licenses granted to Kura thereunder, or otherwise give rise to the applicable upstream licensor’s right to alter or modify the terms under which Kura is licensed the applicable Kura Patents or Kura Know-How; and (vi) Kura has the right to grant the sublicense to KKC with respect to the applicable Kura Patents or Kura Know-How as purported to be granted to KKC hereunder without violating the terms of any Existing Upstream Agreement;

  • other than as set forth in the Existing Upstream Agreements or any Patents or Know-How licensed to Kura by a Third Party service provider or vendor that are not material to the Development, Manufacture of Commercialization of Compounds or the Products, as of the Effective Date, neither Kura nor any of its Affiliates is party to any license agreement with a Third Party pursuant to which Kura or any of its Affiliates is obligated to pay any amount to a Third Party for the practice of any Patents or Know-How with respect to Kura’s or its Affiliates’ Exploitation of Compounds or Products in the Field pursuant to the Agreement;

  • all necessary and material application, registration, maintenance and renewal fees in respect of the Kura Product Patents for which Kura controls the prosecution

  • and maintenance thereof, and, to Kura’s knowledge, the Kura Non-Product Patents, have been paid and all necessary documents and certificates have been filed with the relevant agencies for the purpose of maintaining such Kura Patents;

  • Kura has complied with its duty of candor and disclosure to the United States Patent and Trademark Office and any relevant foreign patent or trademark office with respect to the Kura Patents for which Kura controls the prosecution and maintenance thereof and has made no material misrepresentation in any applications with respect thereto;

  • except for the MSK Patents, the Kura Technology was not developed with funding from the United States government or any other Governmental Authority and no Governmental Authority has any rights in any Kura Technology other than the MSK Patents;

  • neither Kura nor any of its Affiliates is a party to any license or similar agreement under which it has granted or agreed to grant a license to any Third Party to any Kura Technology that conflicts with the rights or licenses granted to KKC under this Agreement;

  • Kura and its employees, consultants and contractors involved in the Development of the Compound and Products in the Territory are not, and have not been, debarred or disqualified by any Regulatory Authority as of the Effective Date, and have complied in all material respects with all Applicable Laws in connection with the Development of the Compound and Products in the Territory. Kura has obtained, or caused its Affiliates, as applicable, to obtain, assignments from all employees, consultants and contractors of any invention claimed in any Kura Patents solely owned by Kura or its Affiliates existing as of the Effective Date at the time of such invention, and to Kura’s knowledge, all such assignments are valid and enforceable;

  • Kura and its Affiliates have made any and all payments owing by Kura or any of its Affiliates to any inventor of any invention claimed in any Kura Patents solely owned by Kura or such Affiliate existing as of the Effective Date that is required to be made under Applicable Law in connection with the transfer of rights under such Kura Patents to Kura or its Affiliate, as applicable;

  • to the knowledge of Kura, there is no infringement of any Kura Technology by any Third Party;

  • to the knowledge of Kura, the Development and Manufacture of the Compound and Products in the Field to the extent currently conducted by Kura in the Territory as of the Effective Date does not infringe any issued Patent of any Third Party, and Kura has not received any written notice from any Third Party asserting or alleging such infringement or misappropriation;

  • no claim or action has been brought against Kura or, to Kura’s knowledge, threatened in writing to Kura, by any Third Party alleging that (i) the Kura Patents are invalid or unenforceable, or (ii) the Exploitation of the Compound or Products in the Field infringes the Patents or misappropriates the Know-How of any Third Party; and, to Kura’s knowledge, no interference, opposition, cancellation or other protest proceeding has been filed against a Kura Patent owned by Kura;

  • neither Kura nor, to Kura’s knowledge, any Person acting on its behalf has: (i) made an untrue statement of a material fact or fraudulent statement to any other Regulatory Authority or with respect to any Regulatory Submissions in each case specifically related to the Compound or any Product; or (ii) failed to disclose a material fact required to be disclosed to such Regulatory Authority, or committed any act, made a statement, or failed to make a statement, in each case in connection with any Regulatory Submission specifically related to the Compound or any Product that, at the time such disclosure was made, would reasonably be expected to provide a basis for a Regulatory Authority to invoke its policy regarding “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy;

  • [***]; and

  • there are no legal claims, judgments or settlements against or owed by Kura or any of its Affiliates, or pending or, to Kura’s or its Affiliates’ knowledge, threatened, legal claims or litigation, in each case, relating to antitrust, anti-competition, violations of Anti-Corruption Laws; and

  • Kura has filed with the Regulatory Authorities in the United States and European Union all safety and efficacy data and information relating to the Products in Kura’s possession that are required to be filed, and has made available to KKJP, all such material safety and efficacy data.

  • Additional Representations and Warranties of KKC. KKC represents and warrants to Kura as of the Effective Date that:

  • KKC has the right under the KKC Technology to grant the licenses to Kura as purported to be granted pursuant to this Agreement;

  • neither KKC nor any of its Affiliates is a party to any license or similar agreement under which it has granted or agreed to grant a license to any Third Party to any KKC Technology that conflicts with the rights or licenses granted to Kura under this Agreement;

  • there are no legal claims, judgments or settlements against or owed by KKC or any of its Affiliates, or pending or, to KKC’s or its Affiliates’ knowledge, threatened, legal claims or litigation, in each case, relating to antitrust, anti-competition, violations of Anti-Corruption Laws;

  • KKC and their Affiliates are not currently engaged in (independently or for or with any Third Party) any Development, Manufacture, Regulatory Approval, use or Commercialization of any small molecule inhibitor that targets the interaction of the protein menin and the protein expressed by KMT2A; and

  • KKC and its and their Affiliates are not, and have not been, debarred or disqualified by any Regulatory Authority or a Prohibited Party.

  • Covenants of Each Party. Each Party covenants to the other Party that in the course of performing its obligations or exercising its rights under this Agreement, it shall, and shall cause its Affiliates and Sublicensees to, comply with the Development Plan and Budget, the U.S. Territory Commercialization Plan and Budget, and all Applicable Laws, including as

  • applicable, cGMP, GCP and GLP standards, and shall not employ or engage any Person who has been debarred by any Regulatory Authority, or, to such Party’s knowledge, is the subject of debarment proceedings by a Regulatory Authority. Without limiting the foregoing, (a) each Party will conduct its obligations with respect to Clinical Trials to be conducted under the Development Plan and Budget in strict adherence with the Development Plan and Budget, as may be amended from time to time, and (b) each Party shall conduct all Clinical Trials in compliance with Applicable Laws, including GCP and the ICH Guidelines, and are approved by the applicable Regulatory Authority. In addition, each Party covenants to the other Party that to such Party’s knowledge, the data and information relating to the Compound and Products provided by such Party to the other Party under this Agreement for purposes of including in an IND or Regulatory Approval Application submitted to any Regulatory Authority shall be true and accurate in all material respects.

  • Compliance with Anti-Corruption Laws.

  • Notwithstanding anything to the contrary in the Agreement, each Party hereby covenants to each other that:

  • it shall not, in the performance of this Agreement, perform any actions that are prohibited by local and other anti-corruption laws, including the provisions of the U.S. Foreign Corrupt Practices Act, as amended, and the U.K. Bribery Act 2010 (collectively “Anti-Corruption Laws”) that may be applicable to either or both Parties to the Agreement;

  • it shall not, in the performance of this Agreement, directly or indirectly, make any payment, or offer or transfer anything of value, or agree or promise to make any payment or offer or transfer anything of value, to a government official or government employee, to any officer, director, or employee of a state-owned or controlled entity or public international organization, to any political party or any candidate for political office, or to any other Third Party with the purpose of influencing decisions related to either Party or its business, or to secure any other improper advantage, in a manner that would violate Anti-Corruption Laws;

  • it shall, on reasonable request by the other Party, provide certifications in writing that to the best of such Party’s knowledge, there have been no violations of Anti-Corruption Laws by such Party or Persons employed by or Subcontractors used by such Party in the performance of the Agreement, or shall provide details of any exception to the foregoing; and

  • it shall maintain records (financial and otherwise) and supporting documentation related to the subject matter of the Agreement in order to document or verify compliance with the provisions of this Section 10.5, and upon reasonable request of the other Party, upon reasonable advance notice, shall provide a Third Party auditor mutually acceptable to the Parties with access to such records for purposes of verifying compliance with the provisions of this Section 10.5. Acceptance of a proposed Third Party auditor may not be unreasonably withheld or delayed by either Party. It is expressly agreed that the costs related to the Third Party auditor shall be fully paid by the Party requesting the audit, and that any auditing activities may not unduly interfere with the normal business operations of the Party subject to such auditing activities. The Audited Party may require the Third Party auditor to enter into a reasonable confidentiality agreement in connection with such an audit.

  • To each Party’s knowledge as of the Effective Date and during the Term, neither such Party nor any of its Affiliates, directors, officers, employees, distributors, agents, representatives, sales intermediaries or other Third Parties acting on behalf of such Party or any of its Affiliates:

  • has taken or shall take any action in violation of any Anti-Corruption Laws;

  • has corruptly offered, paid, given, promised to pay or give, or authorized the provision of, or shall corruptly offer, pay, give, promise to pay or give or authorize the provision of, the payment or gift of anything of value, directly or indirectly, to any Public Official (as defined in Section 10.5(b) below):

  • has influenced or shall influence any act or decision of any Public Official in his or her official capacity;

  • has induced or shall induce such Public Official to do or omit to do any act in violation of his or her lawful duty;

  • has secured or shall secure any improper advantage; or

  • has induced or shall induce such Public Official to use his or her influence with a government, governmental entity, or commercial enterprise owned or controlled by any government (including state-owned or controlled veterinary or medical facilities) in obtaining or retaining any business whatsoever.

  • As of the Effective Date, none of the officers, directors, or employees of each Party or of any of its Affiliates or agents acting on behalf of each Party or any of its Affiliates, in each case that are employed or reside outside the United States, are themselves Public Officials.

  • For purposes of this Section 10.5, “Public Official” means (i) any officer, employee or representative of any regional, federal, state, provincial, county or municipal government or government department, agency or other division; (ii) any officer, employee or representative of any commercial enterprise that is owned or controlled by a government, including any state-owned or controlled veterinary or medical facility; (iii) any officer, employee or representative of any public international organization, such as the African Union, the International Monetary Fund, the United Nations or the World Bank; and (iv) any person acting in an official capacity for any government or government entity, enterprise or organization identified above.

  • Export Control Laws.

  • Neither Party shall export any technology licensed to it by the other Party under this Agreement, except in compliance with Export Control Laws. Each Party shall immediately notify the other Party if such Party has any information or suspicion that there may be a violation of Export Control Laws in connection with such Party’s performance under this Agreement. Upon request, each Party shall provide to the other Party the export control classification number (or ECCN) applicable to technology licensed or otherwise provided under this Agreement.

  • In connection with the exercise of each Party’s rights or performance of its obligations under this Agreement, except as permitted by applicable government license or authorization, it shall not engage in any transactions or dealings with (including export, reexport, or transfer any items to) (i) any country or territory that is subject to an embargo by the U.S. government (currently, Cuba, Iran, North Korea, Syria, and the Crimea, Donetsk People’s Republic, and Luhansk People’s Republic regions of Ukraine) (“Embargoed Country”); (ii) any person or entity located, organized, or resident in an Embargoed Country; (iii) any entity or individual identified on, or 50% or more owned (individually or in the aggregate) by persons identified on, any list of designated and prohibited parties maintained by the United States and other applicable jurisdictions (including, but not limited to, the List of Specially Designated Nationals and Blocked Persons, the Foreign Sanctions Evaders List, and the Sectoral Sanctions Identifications List, which are maintained by the Office of Foreign Assets Control of the U.S. Treasury Department, and the Entity List, Denied Persons List, and Unverified List, which are maintained by the Bureau of Industry and Security of the U.S. Commerce Department) or (iv) the government of Venezuela, including any person or entity employed or owned or controlled, directly or indirectly, by any political subdivision, agency, or instrumentality of the government of Venezuela (collectively, “Prohibited Parties”).

  • Data Privacy and Security.

  • General. With respect to Personal Data Processed in each Party’s respective possession, custody or control as part of such Party’s performance of this Agreement, including the conduct of the Development activities under the Development Plan and Budget and the Ex-U.S. Territory Development Plan, and the preparation and transmission of Personal Data from one Party to the other Party, each Party shall:

  • comply with its respective obligations under applicable Data Protection Laws;

  • at all times during the Term, act in a manner such that it is not subject to any prohibition or restriction which shall (A) prevent or restrict it from disclosing or transferring the Personal Data to the other Party, as may be required under this Agreement; or (B) prevent or restrict it from Processing the Personal Data as envisaged under this Agreement. If either Party becomes aware of any circumstances which it believes, acting reasonably, may give rise to such a prohibition or restriction, it shall promptly notify the other Party of the same and take commercially reasonable steps, including following the other Party’s reasonable instructions, to ensure that it does not impact its performance of its obligations under this Section 10.7;

  • as required by their respective obligations under applicable Data Protection Laws and under this Agreement, at all times during the Term, provide all notices and obtain all consents that are sufficient in scope to enable the other Party to Process the Personal Data as required in order to (A) comply with its obligations under this Agreement and Applicable Laws; and (B) obtain the benefit of its rights and fulfil its obligations under this Agreement (including the transfer of all applicable Personal Data);

  • implement and maintain commercially reasonable administrative, technical, and physical safeguards designed to (A) maintain the security and privacy of the Personal Data; and (B) protect against reasonably anticipated threats or hazards to the security, privacy, availability and/or integrity of the Personal Data and to fulfil any related reporting obligations that may be imposed by Applicable Laws;

  • notify the other Party promptly in writing and without undue delay following receipt of any written correspondence from: (A) a Regulatory Authority in relation to the Processing of Personal Data related to this Agreement, or (B) a data subject exercising their rights under applicable Data Protection Laws such as to access, rectify or delete their Personal Data in relation to the Personal Data Processed under this Agreement;

  • reasonably cooperate with the other Party to enable the other Party to fulfil its obligations, as applicable, under applicable Data Protection Laws; and

  • refrain from taking actions related to the Processing of the Personal Data, which would be reasonably likely to damage or impair the other Party’s reputation.

  • Joint Controllership. If, and to the extent that, the Parties jointly determine the purposes and means of Processing Personal Data under this Agreement, and applicable Data Protection Laws recognize the concept of Joint Controllers, the following provisions apply:

  • The Parties acknowledge and agree that they are Joint Controllers with respect to such Processing. Where the Parties act or will act as Joint Controllers, prior to Processing any such Personal Data under this Agreement, the Parties shall negotiate in good faith to enter in an arrangement or addendum to this Agreement that details their respective obligations under Data Protection Laws as applicable to such Personal Data.

  • With respect to Personal Data Processed under the Agreement in its possession, custody or control, each Party shall notify the other Party promptly and without undue delay upon learning of any (Y) unauthorized access to, or acquisition, disclosure or other Processing of such Personal Data; or (Z) other event or circumstance that constitutes a “personal data breach” or similar term as defined under applicable Data Protection Laws (collectively, a “Data Breach”). The Party that experienced the Data Breach shall promptly investigate each Data Breach that it becomes aware of or has reason to suspect may have occurred and, in the case of a Data Breach shall provide commercially reasonable levels of access and information to the other Party as reasonably requested, in writing, by the other Party. The Parties shall reasonably cooperate in identifying any reasonable steps that should be implemented to limit or stop a Data Breach including, in so far as required by Applicable Law, fulfilment of related reporting obligations to Regulatory Authorities.

  • European Data Transfers. To the extent that a Paty makes a Restricted Transfer to the other Party that is subject to the EU GDPR, the Parties agree that the Standard Contractual Clauses will apply to such Restricted Transfer. The Standard Contractual Clauses are incorporated by reference into this Agreement, and the remaining details required under the Standard Contractual Clauses are deemed completed, as appropriate, with the information set forth in this Agreement and in the Development Plan and Budget and/or the Ex-U.S. Territory Development Plan, as applicable. In the event of any conflict between the Standard Contractual Clauses and any provision of this Agreement, the Standard Contractual Clauses shall prevail. To the extent the Standard Contractual Clauses apply in accordance with this Section 10.7(c), the Parties agree:

  • Clause 7 (Docking Clause) shall not apply;

  • the optional language in Clause 11 (Redress) shall not apply;

  • for Clause 13 (Supervision), the supervisory authority with responsibility for ensuring compliance by the data exporter with the GDPR with regard to Restricted Transfers;

  • for Clause 17 (Governing Law), Option 2 shall apply; and

  • for Clause 18 (Choice of Forum and Jurisdiction), the Parties agree that courts of the jurisdiction in which the data exporter is established shall resolve any disputes arising from the Standard Contractual Clauses.

  • UK Data Transfers. To the extent that a Party makes a Restricted Transfer to the other Party subject to the UK GDPR, the Parties agree that the UK International Data Transfer Addendum will apply to such Restricted Transfer. The UK International Data Transfer Addendum is incorporated by reference into this Agreement, and the remaining details required under the UK International Data Transfer Addendum are deemed completed, as appropriate, with the information set forth in Section 10.7(d) of this Agreement.

  • Compliance with Applicable Data Protection Laws. In the event either Party reasonably determines that applicable Data Protection Laws require the Parties to execute any additional documents or agreements, the Parties shall negotiate in good faith to execute and implement such documents or agreements, including a cross-border data transfer agreement, a transfer impact assessment, a data protection addendum and/or data protection impact assessment.

  • NO OTHER REPRESENTATIONS OR WARRANTIES. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL SUCH REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.

  • Disclaimer under Michigan License. EXCEPT AS EXPRESSLY SET FORTH IN THE MICHIGAN LICENSE, MICHIGAN, [***], FOUNDATION AND LLS MAKE NO REPRESENTATIONS, EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND ASSUME NO RESPONSIBILITIES WHATEVER WITH RESPECT TO DESIGN, DEVELOPMENT, MANUFACTURE, USE, SALE OR OTHER DISPOSITION BY KURA, KKC OR ANY OF ITS OR THEIR AFFILIATES OR SUBLICENSEES OF PRODUCTS COVERED BY THE ZIFTOMENIB COMPOSITION PATENTS.

  • Disclaimer under MSK License. EXCEPT AS EXPRESSLY SET FORTH IN THE MSK LICENSE, MSK MAKES NO REPRESENTATIONS, OR WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY, VALIDITY OF PATENT RIGHTS, CLAIMS ISSUED OR PENDING OR THAT THE MANUFACTURE, SALE OR USE OF THE PRODUCTS WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS.

  • Indemnification

  • By KKC. KKC shall indemnify and hold harmless Kura, its Affiliates, and their directors, officers, employees and agents (individually and collectively, the “Kura Indemnitee(s)”), Michigan, [***], Foundation and LLS (individually and collectively, the “Michigan Indemnitees”), and MSK and its trustees, directors, officers, medical and professional staff, employees, students and agents and their respective successors, heirs and assigns (individually and collectively, the “MSK Indemnitees”) from and against all losses, liabilities, damages and expenses (including reasonable attorneys’ fees, Taxes, penalties, interest and costs) (individually and collectively, “Losses”) incurred by them in connection with any claims, demands, actions or other proceedings by any Third Party (individually and collectively, “Claims”) arising after the Effective Date to the extent arising from (a) the Development, Manufacture, use or Commercialization of the Products in the Territory by or on behalf of KKJP, KKUS or KKC or its Affiliates or Sublicensees (excluding any activities by or on behalf of Kura or its Affiliates or Sublicensees and excluding any activities under the Supply Agreement, which shall be set forth in the Supply Agreement), including from any product liability Claims; (b) the gross negligence or willful misconduct of KKC or any of its Affiliates or Sublicensees; or (c) breach by KKJP, KKUS or KKC of any representations, warranties or covenants made in or pursuant to this Agreement or any covenants or obligations set forth in or entered into pursuant to this Agreement, in each case of clauses (a) through (c) above except to the extent such Losses arise from, are based on, or result from any activity or occurrence for which Kura is obligated to indemnify the KKC Indemnitees under Section 11.2.

  • By Kura. Kura shall indemnify and hold harmless KKC, its Affiliates, and their directors, officers, employees and agents (individually and collectively, the “KKC Indemnitee(s)”), the Michigan Indemnitees and the MSK Indemnitees from and against all Losses incurred by them in connection with any Claims to the extent arising from (a) the Development, Manufacture, or use of the Products in the Territory by or on behalf of Kura or its Affiliates, including from any product liability Claims (excluding any activities by or on behalf of KKJP, KKUS or KKC or its Affiliates or Sublicensees and excluding any activities under the Supply Agreement, which shall be set forth in the Supply Agreement), (b) the registration or Commercialization of the Products in the U.S. Territory by or on behalf of Kura or its Affiliates; (c) the gross negligence or willful misconduct of Kura or any of its Affiliates; or (d) Kura’s or its Affiliates’ breach of any of its representations, warranties or covenants made in or pursuant to this Agreement or any covenants or obligations set forth in or entered into pursuant to this Agreement, in each case of clauses (a) through (d) above, except to the extent Losses arise from, are based on, or result from any activity or occurrence for which KKC is obligated to indemnify the Kura Indemnitees under Section 11.1.

  • Defined Indemnification Terms. Each of the KKC Indemnitee, Kura Indemnitee or Michigan Indemnitee shall be an “Indemnitee”, and the Party that is obligated to indemnify the Indemnitee under Sections 11.1 or 11.2 shall be the “Indemnifying Party.”

  • Defense. If any such Claims described in Sections 11.1 or 11.2 are made, the Indemnitee shall be defended at [***] by counsel selected by the Indemnifying Party and reasonably acceptable to the Indemnitee; provided that the Indemnitee may, [***] also be represented by counsel of its own choosing. The Indemnifying Party shall have the sole right to control the defense of any such Claim, subject to the terms of this ARTICLE 11.

  • Settlement. The Indemnifying Party may settle any such Claim or otherwise consent to an adverse judgment (a) with prior written notice to the Indemnitee but without the consent of the Indemnitee where the only liability to the Indemnitee is the payment of money and the Indemnifying Party makes such payment, or (b) in all other cases, only with the prior written consent of the Indemnitee, such consent not to be unreasonably withheld or delayed.

  • Notice. The Indemnitee shall notify the Indemnifying Party promptly of any Claim with respect to which it seeks indemnification under Sections 11.1 or 11.2 (but in no event shall the Indemnifying Party be liable for any Losses that result from any delay in providing such notice) and shall reasonably cooperate with all reasonable requests of the Indemnifying Party with respect thereto.

  • Permission by Indemnifying Party. The Indemnitee may not settle any such Claim or otherwise consent to an adverse judgment in any such Claim or make any admission as to liability or fault without the express written permission of the Indemnifying Party.

  • Insurance. Each Party shall procure and maintain insurance, including product liability insurance, with respect to its activities hereunder and which is consistent with normal business practices of prudent companies similarly situated at all times [***]. Each Party shall provide the other Party with evidence of such insurance upon request and shall provide the other Party with written notice at least [***] days prior to such Party’s decision or receipt of notice from the insurance company, as applicable, with respect to the cancellation, non-renewal or material decrease in the coverage level of such insurance. It is understood that such insurance shall not be construed to create a limit of either Party’s liability. [***].

  • LIMITATION OF LIABILITY. EXCEPT FOR A BREACH OF SECTION 2.7, SECTION 2.10 OR ARTICLE 9, NEITHER PARTY OR ANY OF ITS AFFILIATES SHALL BE LIABLE TO THE OTHER PARTY UNDER ANY CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, MULTIPLIED OR CONSEQUENTIAL DAMAGES OR FOR LOST PROFITS (EVEN IF DEEMED DIRECT DAMAGES) ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT. IN NO EVENT SHALL MSK BE LIABLE FOR ANY LOST PROFITS, CONSEQUENTIAL, INDIRECT, SPECIAL, INCIDENTAL, OR PUNITIVE DAMAGES ARISING OUT OF OR IN CONNECTION WITH THE MSK LICENSE FROM ITS PERFORMANCE OR NONPERFORMANCE OF ITS OBLIGATIONS UNDER THE MSK LICENSE; PROVIDED THAT NOTHING IN THIS SECTION 11.9 SHALL BE CONSTRUED TO LIMIT A PARTY’S INDEMNIFICATION OBLIGATIONS UNDER SECTION 11.1 OR 11.2.

  • Tax Appendix. With respect to a Party’s indemnification obligations for any Claim related to Taxes that are governed by the Tax Appendix, to the extent of any inconsistencies between this ARTICLE 11 and the Tax Appendix, the terms of the Tax Appendix will apply.

  • Intellectual Property

  • Ownership.

  • As between the Parties, (i) Kura shall remain the sole and exclusive owner of all Kura Technology and (ii) KKC shall remain the sole and exclusive owner of all KKC Technology.

  • Ownership of all Inventions shall be allocated based on inventorship, as determined in accordance with the rules of inventorship under the United States patent laws. A Party shall own all Inventions that are invented, discovered, generated or made solely by or on behalf of it or its Affiliates or their respective employees, agents or independent contractors (“Sole Inventions”) (and, for clarity, any Inventions invented, discovered, generated or made solely by or on behalf of KKUS or KKJP, shall be owned by KKC and considered KKC Sole Inventions), and (i) Kura’s Sole Inventions shall be included in the Kura Technology (if within the scope of such definition) and included in the licenses and rights granted to KKC by Kura hereunder; and (ii) KKC’s Sole Inventions (“KKC Sole Inventions”) shall be included in the KKC Technology (if within the scope of such definition) and included in the licenses and rights granted to Kura by KKC hereunder. The Parties shall jointly own all Inventions that are made jointly by or on behalf of a Party, its Affiliate, or its or its Affiliate’s employees, agents or independent contractors on the one hand and by or on behalf of the other Party, its Affiliates, or its or its Affiliate’s employees, agents or independent contractors on the other hand (“Joint Inventions”). Patents claiming the Joint Inventions shall be referred to as “Joint Patents.” Each Party shall own an undivided equal interest in the Joint Inventions and Joint Patents, without a duty of accounting or an obligation to seek consent from the other Party for the exploitation or license of the Joint Inventions or Joint Patents (subject to the licenses granted to the other Party under this Agreement).

  • Disclosure of Inventions. Each Party shall promptly disclose to the other Party all Inventions, including all invention disclosure or other similar documents submitted to such Party by its or its Affiliates’ employees, agents, or independent contractors relating to such Inventions, and shall also promptly respond to reasonable requests from the other Party for additional information relating to such Inventions.

  • Patent Prosecution.

  • Kura Product Patents and Kura Non-Product Patents.

  • Except as otherwise provided in this Section 12.3(a)(i), as between the Parties, Kura shall have the first right, but not the obligation, to conduct Patent Prosecution of the Kura Product Patents in the Territory using counsel of its own choice. Kura shall consult with KKC and keep KKC reasonably informed of the Patent Prosecution of the Kura Product Patents and shall provide KKC with all material correspondence received from any patent authority in the Territory in connection therewith. In addition, Kura shall provide KKC with drafts of all proposed material filings and correspondence to any patent authority in the Territory in connection with the Patent Prosecution of the Kura Product Patents for KKC’s review and comment prior to the submission of such proposed filings and correspondence. Kura shall consider in good faith KKC’s comments on such Patent Prosecution [***]. Further, Kura shall notify KKC of any decision to cease Patent Prosecution of any Kura Product Patent

  • in any country in the Territory at least [***] days before any due date for filing, payment or other action to avoid loss of rights, in which case KKC shall have the right to continue the Patent Prosecution of such Kura Product Patent in such country in the Territory [***], provided that if Kura makes a decision not to continue the Patent Prosecution of a Kura Product Patent, the Parties shall discuss, through the JPC, Kura’s rationale for not continuing Patent Prosecution of such Kura Product Patent, and KKC shall not have the right to take over the Patent Prosecution of such Kura Product Patent unless the JPC determines that [***]. If KKC decides to take over Patent Prosecution of a Kura Product Patent in any country in the Territory, then such Patent shall no longer be considered a Kura Product Patent, and Kura shall promptly deliver to KKC copies of all necessary files related to such Patent in such country in the Territory and shall take all actions and execute all documents reasonably necessary for KKC to assume such responsibility. For the avoidance of doubt, KKC’s assumption of responsibility for Patent Prosecution of any such Patent in any country in the Territory pursuant to this Section 12.3(a)(i) shall not change the Parties’ respective ownership rights with respect to such Patent.

  • As between the Parties and subject to Sections 12.3(b) and 12.3(c), Kura shall have the sole right, but not the obligation, to conduct the Patent Prosecution of any and all Kura Non-Product Patents, using counsel of its own choice and at its sole cost and expense.

  • Subject to Sections 12.3(b) and 12.3(c), all Out-of-Pocket Expenses incurred in the Patent Prosecution of Kura Product Patents pursuant to Section 12.3(a)(i) and Kura Non-Product Patents pursuant to Section 12.3(a)(ii) (the “Patent Costs”) shall be [***].

  • Ziftomenib Composition Patents. The Parties acknowledge and agree that under the Michigan License, (i) Michigan has the sole right and authority, and, subject to Kura’s obligation to reimburse patent prosecution costs, the obligation, to prepare, file, prosecute (including interferences, oppositions and any other inter partes matters originating in a patent office) and maintain the Ziftomenib Composition Patents in the Territory; (ii) Michigan reserves the right to apply for patent term extension or to demand that Kura apply for patent term extension for the Ziftomenib Composition Patents; and (iii) Kura agrees to cooperate fully with Michigan in the preparation, filing and prosecution of all such patent term extensions for the Ziftomenib Composition Patents and to provide complete copies of any and all documents or other materials that Michigan deems necessary or helpful to undertake such responsibilities. Kura shall provide KKC reasonable opportunity to review and comment on any documents relating to such filing and prosecution efforts that Michigan provides to Kura or that Kura intends to send to Michigan. All costs incurred by Michigan in the course of the preparing, filing, prosecuting and maintaining the Ziftomenib Composition Patents by Michigan [***].

  • MSK Patents. The Parties acknowledge and agree that under the MSK License, MSK has the sole right to prepare, file, prosecute and maintain the MSK Patents in the Territory in countries determined by MSK in its sole discretion, subject to Kura’s reimbursement [***]. Kura shall provide KKC reasonable opportunity to review and comment on any documents relating to the prosecution of the MSK Patents that MSK gives Kura an opportunity to advise on. All costs incurred by MSK in the course of the preparing, filing, prosecuting and maintaining the MSK Patents by MSK [***].

  • Joint Patents. Except as otherwise provided in this Section 12.3(d), as between the Parties, Kura shall have the first right, but not the obligation, to conduct Patent

  • Prosecution of the Joint Patents in and outside the Territory, using counsel of its own choice. Kura shall consult with KKC and keep KKC reasonably informed of the Patent Prosecution of the Joint Patents and shall provide KKC with all material correspondence received from any patent authority in the Territory in connection therewith. In addition, Kura shall provide KKC with drafts of all proposed material filings and correspondence to any patent authority in the Territory in connection with the Patent Prosecution of such Joint Patents for KKC’s review and comment prior to the submission of such proposed filings and correspondence. Kura shall consider in good faith KKC’s comments on such Patent Prosecution [***]. Further, Kura shall notify KKC of any decision to cease Patent Prosecution of any such Joint Patent in any country in the Territory at least [***] days before any due date for filing, payment or other action to avoid loss of rights, in which case KKC shall have the right to continue the Patent Prosecution of such Joint Patent in such country in the Territory [***]. If KKC decides to take over Patent Prosecution of a Joint Patent in such country in the Territory, then Kura shall promptly deliver to KKC copies of all necessary files related to such Joint Patent in such country in the Territory and shall take all actions and execute all documents reasonably necessary for KKC to assume such responsibility. For the avoidance of doubt, KKC’s assumption of responsibility for Patent Prosecution of any Joint Patent in any country in the Territory pursuant to this Section 12.3(d) shall not change the Parties’ respective ownership rights with respect to such Joint Patent. All direct expenses paid or payable by Kura or its Affiliates to Third Parties (other than employees of Kura or its Affiliates) that are specifically identifiable and incurred in the Patent Prosecution of Joint Patents pursuant to this Section 12.3(d) for the Territory will be [***].

  • KKC Patents. KKC shall have the sole right, but not the obligation, to conduct the Patent Prosecution of any KKC Patents (excluding any Joint Patents), using counsel of its own choice and at its sole cost and expense; provided that KKC shall consult with Kura and keep Kura reasonably informed of the Patent Prosecution of the KKC Patents and shall provide Kura with all material correspondence received from any patent authority in the Territory in connection therewith. In addition, KKC shall provide Kura with drafts of all proposed material filings and correspondence to any patent authority in the Territory in connection with the Patent Prosecution of the KKC Patents for Kura’s review and comment prior to the submission of such proposed filings and correspondence. KKC shall, through the JPC, consider in good faith Kura’s comments on such Patent Prosecution. Further, KKC shall notify Kura of any decision to cease Patent Prosecution of any KKC Patent in any country in the Territory at least [***] days before any due date for filing, payment or other action to avoid loss of rights, in which case Kura shall have the right to continue the Patent Prosecution of such KKC Patent in such country in the Territory [***], provided that if KKC makes a decision not to continue the Patent Prosecution of a KKC Patent in any country, the Parties shall discuss, through the JPC, KKC’s rationale for not continuing Patent Prosecution of such KKC Patent, and Kura shall not have the right to take over the Patent Prosecution of such KKC Patent unless the JPC determines that [***]. If Kura decides to take over Patent Prosecution of a KKC Patent in any country in the Territory, KKC shall promptly deliver to Kura copies of all necessary files related to such Patent in such country in the Territory and shall take all actions and execute all documents reasonably necessary for Kura to assume such responsibility. For clarity, Kura’s assumption of responsibility for Patent Prosecution of any such Patent in any country in the Territory pursuant to this Section 12.3(e) shall not change the Parties’ respective ownership rights with respect to such Patent.

  • Cooperation. Each Party will cooperate with the other Party in connection with all activities relating to the Patent Prosecution of the Kura Patents and KKC Patents undertaken by such other Party pursuant to this Section 12.3, including: (i) executing

  • all papers and instruments, or requiring its employees or contractors, to execute such papers and instruments, so as to effectuate the ownership of Inventions set forth in Section 12.1, and Patents claiming such Inventions, and to enable the other Party to conduct all activities relating to the Patent Prosecution of the Kura Patents and KKC Patents as permitted by this Section 12.3; and (ii) promptly informing the other Party of any matters coming to such Party’s attention that may materially affect the Patent Prosecution of any Kura Patent or KKC Patent. Each Party will also promptly provide to the other Party all information reasonably requested by such other Party with regard to such Party’s activities pursuant to this Section 12.3.

  • Enforcement.

  • Each Party shall notify the other within [***] Business Days of becoming aware of any alleged or threatened infringement by a Third Party of any of the Kura Patents (including Joint Patents within the Kura Patents) in the Territory through the making, having made, using, selling, offering for sale or importing of any Competing Product or any other product that is, or is reasonably expected to be, competitive with a Product in the Field in the Territory (a “Product Infringement”).

  • Kura shall have the first right, but not the obligation, to bring and control any legal action or proceeding in connection with any Product Infringement with respect to any Kura Product Patent or Joint Patent in the U.S. Territory at its own expense as it reasonably determines appropriate. If Kura does not bring such legal action prior to the earlier of: (i) [***] days following Kura’s receipt or delivery of the notice under Section 12.4(a), or (ii) [***] days before the deadline, if any, set forth in the Applicable Laws for the filing of such action or proceeding, or discontinues the prosecution of any such action or proceeding after filing without abating such infringement, KKC shall have the right to bring and control any such legal action or proceeding in connection with such Product Infringement with respect to such Kura Product Patent at its own expense as it reasonably determines appropriate, provided that if Kura makes a decision to not bring and control any legal action or proceeding in connection with any Product Infringement with respect to any Kura Product Patent in the U.S. Territory, the Parties shall discuss, through the JPC, Kura’s rationale for not bringing such legal action or proceeding, and [***]. In an action or proceeding described in this Section 12.4(b) with respect to a Product in the U.S. Territory, the Out-of-Pocket Expenses incurred by the Parties arising from such action or proceeding will be [***].

  • KKC shall have the first right, but not the obligation, to bring and control any legal action or proceeding in connection with any Product Infringement with respect to any Kura Product Patent or Joint Patent in the Ex-U.S. Territory at its own expense as it reasonably determines appropriate. If KKC does not bring such legal action prior to the earlier of: (i) [***] days following KKC’s receipt or delivery of the notice under Section 12.4(a), or (ii) [***] days before the deadline, if any, set forth in the Applicable Laws for the filing of such action or proceeding, or discontinues the prosecution of any such action or proceeding after filing without abating such infringement, then Kura shall have the right to bring and control any such legal action or proceeding in connection with such Product Infringement with respect to such Kura Product Patent at its own expense as it reasonably determines appropriate, provided that if KKC makes a decision to not bring and control any legal action or proceeding in connection with any Product Infringement with respect to any Kura Product Patent in the Ex-U.S. Territory, the Parties shall discuss, through the JPC, KKC’s rationale for not bringing such legal action or proceeding, and [***].

  • As between the Parties, Kura shall have the sole right, but not the obligation, to bring and control any legal action or proceeding in connection with any Product Infringement with respect to any Kura Non-Product Patents or Ziftomenib Composition Patents in the Territory at its own expense as it reasonably determines appropriate, provided that Kura will consult with KKC on, and shall keep KKC informed of, any strategy and actions it is taking (or refraining from taking) with respect to the Product Infringement of the Ziftomenib Composition Patents, and consider in good faith KKC’s reasonable comments with respect thereto that are in the best interest of the Products, taking into consideration [***]. If Kura does not bring such legal action or proceeding in connection with any Product Infringement with respect to any Ziftomenib Composition Patents prior to the earlier of: (i) [***] days following Kura’s receipt or delivery of the notice under Section 12.4(a), or (ii) [***] days before the deadline, if any, set forth in the Applicable Laws for the filing of such action or proceeding, or discontinues the prosecution of any such action or proceeding after filing without abating such infringement, KKC shall have the right to bring and control any such legal action or proceeding in connection with such Product Infringement with respect to such Ziftomenib Composition Patents at its own expense as it reasonably determines appropriate, provided that (A) [***], and (B) if Kura makes a decision to not bring and control any legal action or proceeding in connection with any Product Infringement with respect to any Ziftomenib Composition Patents, the Parties shall discuss, through the JPC, Kura’s rationale for not bringing such legal action or proceeding, and [***]. For clarity, pursuant to the MSK License, MSK has the sole right, but not the obligation, to bring and control any legal action relating to the MSK Patents.

  • Kura shall have the sole right, but not the obligation, to bring and control any legal action or proceeding in connection with any alleged or threatened infringement by a Third Party of any of (i) the Kura Patents (excluding Joint Patents within the Kura Patents) in the Territory that is not a Product Infringement, or (ii) the Kura Patents (excluding Joint Patents within the Kura Patents) outside the Field, in either case of clause (i) or (ii) at its own expense as it reasonably determines appropriate.

  • As between Kura and KKC, either Party may bring any legal action or proceeding in connection with any alleged or threatened infringement by a Third Party of any of the Joint Patents in the Territory that is not a Product Infringement, [***]. If a Party so desires, the other Party shall reasonably cooperate with the other Party in connection with such action or proceeding (including consenting to such action or proceeding, or joining such action or proceeding to the extent required under Applicable Law).

  • KKC shall have the sole right, but not the obligation, to bring and control any legal action or proceeding in connection with any alleged or threatened infringement by a Third Party of any of the KKC Patents [***], at its own expense as it reasonably determines appropriate.

  • Notwithstanding any provision to the contrary in this Section 12.4, should a Party receive a certification for a Product pursuant to the Hatch-Waxman Act, or its equivalent in a country other than the U.S. in the Territory, with respect to any activities with respect to such Product in the Field in the Territory, then such Party will immediately provide the other Party with a copy of such certification. For each Product in the Territory, Kura will have [***] days from the date on which it receives or provides a copy of such certification to provide written notice to KKC whether Kura will bring suit, within a [***] day period from the date of such certification. Should such [***] day period expire without Kura bringing suit or providing such written notice, then KKC will be free to bring suit in its name, provided that (i)

  • [***] if Kura makes a decision to not bring suit, the Parties shall discuss, through the JPC, Kura’s rationale for not bringing such legal action or proceeding, and [***], then KKC shall not have such right to bring suit [***].

  • At the request of the Party bringing an action related to Product Infringement or otherwise as described in this Section 12.4, the other Party shall provide reasonable assistance in connection therewith, including by executing reasonably appropriate documents, cooperating in discovery and joining as a party to the action if required by Applicable Laws to pursue such action, [***]. In connection with an action related to Product Infringement or otherwise as described in this Section 12.4, the Party bringing the action shall not enter into any settlement admitting the invalidity or non-infringement of, or otherwise impairing the other Party’s rights in the Kura Patents, KKC Patents or Joint Patents, as applicable, without the prior written consent of the other Party. The enforcing Party shall keep the non-enforcing Party reasonably informed of the status of any action it brought in connection with such Product Infringement or otherwise as described in this Section 12.4. In connection with an action or proceeding described in Sections 12.4(b), (c), (d), or (h), as applicable, (i) the non-enforcing Party shall be entitled to attend any substantive meetings, hearings, or other proceedings related to any such action pursued by the enforcing Party, and (ii) the enforcing Party shall provide the non-enforcing Party with copies of all pleadings and other documents to be filed with the court reasonably in advance and shall consider in good faith reasonable and timely input from the non-enforcing Party during the course of the action.

  • Any recoveries resulting from enforcement action or proceeding relating to a claim of Product Infringement or otherwise as described in this Section 12.4 shall be first applied against payment of the enforcing Parties’ costs and expenses in connection therewith and then the non-enforcing Party’s costs and expenses in connection therewith (which amounts shall be allocated pro rata if insufficient to cover the totality of such expenses). Any such recoveries in excess of such costs and expenses: [***].

  • Defense. As between the Parties, the Party controlling the Patent Prosecution of any Patent under Section 12.3 will have the right (but not the obligation), at its sole discretion, to defend against a declaratory judgment action, inter partes review, opposition proceeding, interference, or other legal or administration action alleging invalidity, unpatentability, unenforceability or non-infringement (or non-misappropriation) of any such Patent. If the Party controlling such Patent Prosecution of any Kura Product Patents or Joint Patents under Section 12.3(a)(i) does not defend such Patent under this Section 12.5 within [***] days, or elects not to continue any such defense (in which case it will promptly provide notice thereof to the other Party), then the other Party will have the right (but not the obligation), at its sole discretion, to defend any such Patent. Any awards or amounts received in defending any such action will be allocated between the Parties as provided in Section 12.4(j).

  • Defense Against Third Party Infringement Claim.

  • Each Party shall notify the other in writing of any allegations it receives from a Third Party that the Development, Manufacture, registration, use or Commercialization of any Product in the Territory or any embodiment of any technology or intellectual property licensed by a Party to the other Party under this Agreement infringes the intellectual property rights of such Third Party (a “Third Party Infringement Claim”). Such written notice of a Third Party Infringement Claim (a “Third Party Infringement Notice”) shall (i) be provided promptly, but in no event after more than [***] days following receipt of such allegations; and

  • (ii) include a copy of any summons or complaint (or the equivalent thereof) received regarding the foregoing. Promptly following receipt of the Third Party Infringement Notice, the Parties will promptly meet to discuss the defense of such claim, and the Parties [***].

  • Upon the defending Party’s request [***], the non-defending Party shall provide reasonable assistance to the defending Party for such defense and shall join such suit if deemed a necessary party. If the non-defending Party does not join such suit, the defending Party shall keep the non-defending Party reasonably informed of the status of such suit. The non-defending Party shall be entitled to attend any substantive meetings, hearings, or other proceedings related to such suit. The defending Party shall provide the non-defending Party with copies of all pleadings and other documents to be filed with the court reasonably in advance and shall consider in good faith reasonable and timely input from the non-defending Party during the course of the suit.

  • Third Party Rights. Each Party’s rights and obligations under this ARTICLE 12 with respect to any Kura Patent or KKC Patent licensed to the other Party by a Third Party shall be subject to the rights of such Third Party with respect to such Patent under the applicable Upstream Agreement between such Party and such Third Party, [***].

  • Orange Book Listing. KKC and Kura will discuss in good faith the Kura Patents and KKC Patents that will be included in the Orange Book maintained by the FDA or similar or equivalent patent listing source, if any, in other countries in the Territory for Products. After considering the other Party’s comments in good faith, (a) Kura will have the sole right to determine which Kura Patents or KKC Patents will be included for the U.S. Territory, and (b) KKC will have the sole right to determine which Kura Patents or KKC Patents will be included for the Ex-U.S. Territory, [***]. Kura will provide such assistance as may be reasonably requested by KKC in connection with such listing of Kura Patents. KKC will provide such assistance as may be reasonably requested by Kura in connection with such listing of KKC Patents.

  • Patent Term Extension. The Parties shall, through the JPC, decide upon the strategy and timing to seek patent term extensions, patent term restorations, and supplemental protection certificates or the like (collectively, “Extensions”) that are now or become available under Applicable Laws, including 35 U.S.C. § 156 and applicable foreign counterparts, in any country in the Territory in relation to the for the Kura Patents. If the Parties decide to seek any such Extensions, each Party shall cooperate with the other Party in obtaining such Extension with respect to such Kura Patents in any country or region where applicable. [***].

  • Patent Marking. KKC shall, and shall require its Affiliates and Sublicensees, to, mark Products sold by it in the Territory (in a reasonable manner consistent with industry custom and practice) with appropriate patent numbers or indicia as required by Applicable Laws in those countries in which such numbers or indicia impact recoveries of damages or equitable remedies available with respect to the infringement or enforcement of Patents (including the requirements of 35 U.S.C. § 287 or its foreign equivalents) or are otherwise required to comply with Applicable Laws governing the manufacture, use or sale of Products in such countries.

  • Product Marks and Corporate Names and Logos.

  • U.S. Territory. Kura shall be responsible for the selection, searching, clearance, filing, registration, maintenance and defense of the trademarks used to identify the

  • Products, and all trademarks, logos, taglines, trade dress, domain names and/or indicia of origin for use in connection with the sale or marketing of Products (the “Kura Product Marks”) in the U.S. Territory provided [***]. Without limiting the foregoing, prior to submitting an application for any new Kura Product Marks in the U.S. Territory, Kura shall notify KKC of such intent. Kura shall consider in good faith any comments that KKC may have with respect to such prospective Kura Product Mark, [***]. All expenses associated therewith during the U.S. Territory Term shall be shared by the Partnership Parties as Shared Commercial Costs. All uses of the Kura Product Marks shall be reviewed by the JCC and shall comply with all Applicable Laws (including those laws and regulations particularly applying to the proper use and designation of trademarks in the applicable countries). Kura shall own all right, title and interest in and to the Kura Product Marks. Schedule 12.11 sets forth a complete list all Kura Product Marks existing as of the Effective Date.

  • Ex-U.S. Territory. Subject to compliance with the Global Branding Strategy, KKC shall have the right to either (i) use a Kura Product Mark in connection with the Commercialization of the Product(s) in the Field in the Ex-U.S. Territory or (ii) generate and register its own trademark for the Product(s) (a “KKC Product Mark”) and register such KKC Product Mark in connection with the Commercialization of the Products in the Field in the Ex-U.S. Territory at its own cost and expense. All uses of the KKC Product Marks shall be reviewed by the JCC and shall comply with all Applicable Laws (including those laws and regulations particularly applying to the proper use and designation of trademarks in the applicable countries). KKC shall own all right, title and interest in and to the KKC Product Marks.

  • Licenses.

  • During the U.S. Territory Term, subject to the terms and conditions of this Agreement, Kura hereby grants to KKC the right, free of charge, to use the Kura Product Marks solely for the purpose of Co-Promoting the Products in accordance with the terms of this Agreement and the Co-Promotion Agreement.

  • If KKC elects to use a Kura Product Mark in connection with the Commercialization of the Product in the Field in the Ex-U.S. Territory, then subject to the terms and conditions of this Agreement, Kura hereby grants to KKC the exclusive right, free of charge, with the right to sublicense (including through multiple tiers), to use the Kura Product Marks solely in connection with the Commercialization of the Product in the Field in the Ex-U.S. Territory. In this case, Kura shall have local transliterations of Kura Product Mark registered, filed, maintained and renewed in Ex-U.S. Territory upon KKC’s request (the choice of which transliterations (including characters to be used therein) to be discussed by the Parties and agreed in good faith and the cost of which shall be borne by KKC), and shall keep KKC reasonably informed of the completion of such registration process and provide KKC with updated list of registration numbers for such Kura Product Mark in Ex-U.S. Territory (e.g., with respect to Japan, KATAKANA character trademark). Following such registration, the applicable transliteration shall be considered a Kura Product Mark and licensed to KKC under the same terms as the corresponding original Kura Product Mark. Further, in connection with the foregoing, upon KKC’s reasonable request from time-to-time, Kura shall provide KKC a list of Kura Product Marks including registration number, class and product/service.

  • During the U.S. Territory Term, subject to the terms and conditions of this Agreement, KKC hereby grants to Kura the right, free of charge, to use the

  • KKC name and logo in the U.S. Territory solely for the purpose of Co-Promoting the Products in accordance with the terms of this Agreement and the Co-Promotion Agreement.

  • During the U.S. Territory Term, subject to the terms and conditions of this Agreement, Kura hereby grants to KKC the right, free of charge, to use the Kura name and logo in the U.S. Territory solely for the purpose of Co-Promoting the Products in accordance with the terms of this Agreement and the Co-Promotion Agreement.

  • Use of Names and Logos. All Products bearing the names and/or logos of the other Party shall be manufactured in accordance with the quality standards established by the JSC and other reasonable quality standards provided by one Party to the other Party. KKC shall remain the owner of the KKC name and logo and the trademarks and the goodwill pertaining thereto. Kura shall remain the owner of the Kura name and logo and the trademarks and the goodwill pertaining thereto. Neither Party shall, without the other Party’s prior written consent, use any trademarks or house marks of the other Party (including the other Party’s corporate name), or marks confusingly similar thereto, in connection with such Party’s marketing or promotion of Products under this Agreement, except as provided in this Section 12.11 and except to the extent required to comply with Applicable Laws.

  • Notice of Infringement. In the event that either Party becomes aware of any infringement or threatened infringement by a Third Party of any Kura Product Marks or KKC Product Marks, it will promptly notify the other Party in writing. Any such notice shall include evidence to support an allegation of infringement or threatened infringement, or declaratory judgment or equivalent action, by such Third Party. The Parties shall cooperate with one another to resolve any such infringement or threatened infringement.

  • Expiration of the U.S. Territory Term or Ex-U.S. Territory Term. Notwithstanding anything to the contrary in this Agreement, the Parties’ rights and obligations under Section 12.3 through Section 12.8 with respect to the prosecution, enforcement and defense of any Kura Patent, Joint Patent and KKC Patent and other related matters shall expire (a) in the U.S. Territory upon the expiration of the U.S. Territory Term, and (b) in the Ex-U.S. Territory upon the expiration of the Ex-U.S. Territory Term (on a country-by-country basis), as applicable.

  • Terms and Termination

  • Term and Expiration.

  • Term. The term of this Agreement shall be effective as of the Effective Date and, unless earlier terminated as provided in this ARTICLE 13 or Section 2.10(b)(2), shall continue in effect until the later to occur of (i) the expiration of the U.S. Territory Term and (ii) the expiration of the Ex-U.S. Territory Term (the “Term”, and the date of such expiration with respect to such region, the “Expiration Date”). Upon the expiration of the Term, the licenses granted to Kura under Section 2.4 shall become fully paid-up, perpetual, irrevocable and sublicensable in multiple tiers.

  • Expiration of Royalty Term. On a country-by-country basis in U.S. Territory or the Ex-U.S. Territory, upon the expiration of the Royalty Term for a Product in a given country in the U.S. Territory or the Ex-U.S. Territory, the licenses granted by Kura to

  • KKC under Section 2.1(b) and 12.11(c)(ii) in such country with respect to such Product in the Field shall become fully paid-up, perpetual, irrevocable and sublicensable in multiple tiers.

  • Termination for Mutual Agreement. This Agreement may be terminated by the Parties’ mutual written agreement.

  • Termination for Convenience. KKC shall have the right to terminate this Agreement in its entirety for any or no reason upon twelve (12) months’ prior written notice to Kura.

  • Termination by KKC for Material Adverse Regulatory Event, [***] or Major Filing Delays. In the event that [***] that Development and/or Commercialization of the Product is [***] due to: (a) a Material Adverse Regulatory Event, (b) [***], or (c) Major Filing Delays, KKC shall notify Kura accordingly. The Parties shall discuss in good faith regarding [***] as a result of the foregoing, including whether there are any solutions to ensure that the Compound and Product [***]. If, [***], the Parties are unable to reach a solution to overcome such [***] that is reasonably acceptable to both Parties, or if the Parties disagree as to whether [***], KKC shall have the right to terminate this Agreement with six (6) months’ prior written notice to Kura.

  • Termination for Material Breach.

  • This Agreement may be terminated in its entirety at any time during the Term upon [***] days’ (or [***] days’ with respect to any payment breach) written notice by either Party if the other Party is in material breach of this Agreement and, if such breach is curable, such breach has not been cured within [***] days (or [***] days with respect to any payment breach) of such written notice.

  • Notwithstanding the foregoing, if the alleged breaching Party disputes the existence or materiality of the alleged breach, the other Party shall not have the right to terminate this Agreement unless and until it is determined in accordance with ARTICLE 14 that the alleged breaching Party has materially breached this Agreement and fails to cure such breach within sixty (60) days after such determination.

  • Termination for Insolvency. A Party shall have the right to terminate this Agreement upon delivery of written notice to the other Party in the event that (a) such other Party files in any court or agency pursuant to any statute or regulation of any jurisdiction a petition in bankruptcy or insolvency or for reorganization or similar arrangement for the benefit of creditors or for the appointment of a receiver or trustee of such other Party or its assets, (b) such other Party is served with an involuntary petition against it in any insolvency proceeding and such involuntary petition has not been stayed or dismissed within [***] days of its filing, or (c) such other Party makes an assignment of substantially all of its assets for the benefit of its creditors.

  • Termination for Patent Challenge. Except to the extent the following is unenforceable under the laws of a particular jurisdiction, Kura may terminate this Agreement in its entirety (a) immediately upon written notice to KKC if KKC or any of its Affiliates or Sublicensees commences a legal, administrative or other action challenging the validity, enforceability or scope of any Kura Patent or (b) within [***] day written notice to KKC if KKC or its Affiliates or Sublicensees commences a legal, administrative or other action challenging the validity, enforceability or scope of any Patent (other than any Kura Patent)

  • owned or Controlled by Kura or its Affiliates anywhere in the world, unless such action is withdrawn during such [***]-day period. Notwithstanding the foregoing, if during such [***]-day period KKC terminates the sublicense agreement of any Sublicensee that commences a legal action challenging the validity, enforceability or scope of any Kura Patents anywhere in the world, Kura shall not have the right to terminate this Agreement under this Section 13.7.

  • Election to Terminate. If either Party has the right to terminate under Sections 13.3 through 13.7, it may at its sole option, elect either to (a) terminate this Agreement and pursue any legal or equitable remedy available to it or (b) maintain this Agreement in effect and pursue any legal or equitable remedy available to it.

  • Effects of Termination.

  • General. Upon the termination (but not, for clarity, expiration) of this Agreement for any reason, all rights and licenses granted to KKC herein shall immediately terminate, and all sublicenses of such rights and licenses shall also terminate. Upon termination of this Agreement, if any Sublicensee with the exclusive right to Commercialize Products in any country in the Ex-U.S. Territory pursuant to the license granted under Section 2.1(b)(i) is then in good standing under its sublicense agreement with KKC, then Kura shall enter into a direct license with such Sublicensee under the Kura Technology that is the same scope as the sublicense granted by KKC on substantially the same terms and conditions set forth in this Agreement, and Section 13.9(b) below shall not apply to such Sublicensee. Termination of this Agreement for any reason shall not release either Party of any obligation or liability which, at the time of such termination, has already accrued to the other Party or which is attributable to a period prior to such termination. Notwithstanding anything herein to the contrary, termination of this Agreement by a Party shall be without prejudice to other remedies such Party may have at law or equity.

  • Additional Terms. Upon termination of this Agreement for any reason (but not, for clarity, expiration), the following additional provisions shall apply:

  • Reversion of Rights to Kura; License to Kura. Any rights and licenses with respect to the Products granted to KKC under this Agreement shall immediately terminate, and all such rights shall revert back to Kura. Effective upon any termination of this Agreement other than by KKC pursuant to Section 13.5, upon Kura’s request, KKC will grant, and hereby does grant (which license shall be exercisable only upon the effective date of such termination), to Kura a worldwide, royalty-bearing (subject to Section 13.9(b)(ii)) license, with the right to grant sublicenses (through multiple tiers), under the KKC Reversion Technology [***] in the Field (the “Reversion License”), provided that to the extent any such KKC Reversion Technology are in-licensed or acquired by KKC from a Third Party, [***]. The Reversion License shall be non-exclusive or exclusive upon [***] following any termination of this Agreement other than [***] and subject to the Parties’ agreement on the Reversion Royalty as further described in Section 13.9(b)(ii). Upon any termination of this Agreement by KKC pursuant to Section 13.5, upon Kura’s request, KKC will negotiate in good faith with Kura, for a period of [***] days following the effective date of such termination, the terms of a Reversion License, including whether such Reversion License shall be non-exclusive or exclusive and the applicable Reversion Royalty for such Reversion License.

  • Reversion Royalty. Upon any termination of this Agreement other than by [***], the Parties will negotiate in good faith for a period of [***] days following the effective date of such termination to agree on a commercially reasonable royalty for the

  • Reversion License granted to Kura under Section 13.9(b)(i) with respect to KKC Reversion Technology (the “Reversion Royalty”) and such other terms and conditions (except as expressly set forth herein) applicable to Kura’s practice of the Reversion License. In determining the amount of such Reversion Royalty payable by Kura to KKC, the Parties will take into account, among other things, (i) [***], (ii) [***], (iii) [***], and (iv) [***]. If the Parties are unable to agree on the applicable Reversion Royalty within [***] days after the effective date of termination, then either Party may refer such matter for resolution pursuant to Schedule 1.204. The terms of Sections 8.7, 8.9, 8.10, 8.11, 8.12 and 8.12 (and relevant defined terms) will apply to the payment and reporting of any Reversion Royalties described in this Section 13.9(b)(ii), as modified to apply to royalties payable on Products by Kura to KKC with respect to a license under the Know-How and Patents described herein by KKC to Kura.

  • Regulatory Materials; Data. KKC shall, and shall cause its Affiliates and Sublicensees to, [***], to the maximum extent permitted by Applicable Laws at the time of any such termination to promptly (1) assign all Regulatory Submissions and Regulatory Approvals and pricing and reimbursement approvals of Products to Kura, and (2) assign all data generated by or on behalf of KKC or its designee while conducting Development or Commercialization activities under this Agreement to Kura or its designee, including non-clinical and clinical studies conducted by or on behalf of KKC on Products and all pharmacovigilance data (including all Adverse Event database information) on Products.

  • Trademarks. At Kura’s request, on a KKC Product Mark-by-KKC Product Mark and country-by-country basis, KKC shall, and shall cause its Affiliates and Sublicensees, to promptly transfer and assign to Kura, [***], each such Product Mark in such country in the Territory (but, for clarity, not any KKC house marks) owned by KKC and used solely in connection with the Commercialization of the terminated Products, in exchange for a payment to KKC in an amount equal to [***] percent ([***]%) of KKC’s cumulative incurred costs related to the development, clearance, registration, and maintenance of such Product Mark in such country in the Territory. To the extent any KKC Product Mark cannot be assigned to Kura under Applicable Law, KKC agrees to grant and hereby grants to Kura a perpetual, worldwide, royalty-free, fully paid up, exclusive right and license to the KKC Product Marks.

  • Transition Assistance. KKC shall, and shall cause its Affiliates and Sublicensees, to provide reasonable assistance for a period not to exceed [***] days following the effective date of termination of the Agreement, as may be reasonably necessary or useful for Kura or its designee to commence or continue Developing, Manufacturing or Commercializing Products in the Territory (the “Transition Period”) to the extent KKC is then performing or having performed such activities, including transferring or amending as appropriate, upon request of Kura, any agreements or arrangements with Third Party to Develop, Manufacture or Commercialize the Products in the Territory. To the extent that any such contract between KKC and a Third Party is not assignable to Kura or its designee, then KKC shall reasonably cooperate with Kura to arrange to continue to and provide such services from such entity. Any transition assistance provided by KKC under this Section 13.9(b)(v) shall be [***], provided that if KKC terminates this Agreement pursuant to Section 13.3 or Kura terminates this Agreement pursuant to Section 13.5 or Section 13.7, such transition assistance shall be [***].

  • Ongoing Clinical Trial. If at the time of such termination, any Clinical Trials for the Products are being conducted by or on behalf of KKC, then, at Kura’s election on a Clinical Trial-by-Clinical Trial basis, in each case subject to Applicable Laws: (1) KKC shall, and shall cause its Affiliates and Sublicensees to, (A) continue to conduct such

  • Clinical Trial during the Transition Period or another period of time as determined by Kura after the effective date of such termination [***], and (B) after such period, to (y) fully cooperate with Kura to transfer the conduct of all such Clinical Trials to Kura or its designee or (z) continue to conduct such Clinical Trials, [***] for so long as necessary to enable such transfer to be completed without interruption of any such Clinical Trials and (C) Kura shall assume any and all liability and costs for such Clinical Trials after the effective date of such termination, and (2) KKC shall, and shall cause its Affiliates and Sublicensees to, [***], orderly wind down the conduct of any such Clinical Trial which is not assumed by Kura under clause (1).

  • Inventory. At Kura’s election and request, KKC shall (1) transfer to Kura or its designee all inventory of Manufacturing materials including process intermediates, reagents, the Compound and Products for clinical and commercial supplies (including all final Products and bulk tablets, or in any other form(s)) then in possession or control of KKC, its Affiliates or Sublicensees; provided that [***] or (2) (A) continue to use Commercially Reasonable Efforts to Commercialize all inventory of the Products then in possession or control of KKC during the Transition Period and make the corresponding payments, including any Milestone Payments or royalties to Kura under this Agreement as though this Agreement had not been terminated and (B) after the Transition Period, transfer to Kura or its designee any remaining inventory of the Manufacturing materials including process intermediates, reagents, Compounds, and Products to Kura or its designee [***].

  • Return of Confidential Information. At the Disclosing Party’s election, the Receiving Party shall return (at Disclosing Party’s expense) or destroy all tangible materials comprising, bearing, or containing any Confidential Information of the Disclosing Party relating to the Products that are in the Receiving Party’s or its Affiliates’ or Sublicensees’ possession or control and provide written certification of such destruction (except to the extent any information is the Confidential Information of both Parties or to the extent that the Receiving Party has the continuing right to use the Confidential Information under this Agreement); provided that the Receiving Party may retain one copy of such Confidential Information for its legal archives. Notwithstanding anything to the contrary set forth in this Agreement, the Receiving Party shall not be required to destroy electronic files containing such Confidential Information that are made in the ordinary course of its business information back-up procedures.

  • Other Remedies. Termination or expiration of this Agreement for any reason shall not constitute a waiver or release of, or otherwise be deemed to prejudice or adversely affect, any rights, remedies or claims, whether for damages or otherwise, that a Party may have hereunder or that may arise out of or in connection with such termination or expiration.

  • Termination by KKC Due to Material Breach. Upon the termination of this Agreement by KKC pursuant to Section 13.5 or 13.6, all of the provisions of Section 13.9(b) shall apply, except that to the extent KKC is obligated to perform under any of the provisions of Sections 13.9(b)(i), 13.9(b)(iii), 13.9(b)(iv), 13.9(b)(v), or 13.9(b)(vi) except as expressly set forth in the applicable provision, [***].

  • Survival. Termination or expiration of this Agreement shall not affect any rights or obligations of the Parties under this Agreement that have accrued prior to the date of termination or expiration. The following provisions shall survive the termination or expiration of this Agreement for any reason: ARTICLE 1, Section 2.6, Section 4.12, ARTICLE 8 (solely to the

  • extent payments have accrued prior to the effective date of termination, except that Section 8.13, Section 8.14 and the Tax Appendix shall survive with respect to any Taxes, penalties, and interest asserted by the relevant tax authorities), ARTICLE 9 (other than Section 9.4 or 9.5), Section 10.7(b), Section 10.8, Section 10.9, Section 10.10, ARTICLE 11, Section 12.1, Section 13.1 (which shall survive only with respect to licenses that have become perpetual and irrevocable prior to the expiration or early termination of this Agreement), Section 13.9 (to the extent applicable), Section 13.10, ARTICLE 14, and ARTICLE 15.

  • Dispute Resolution

  • General. The Parties recognize that a claim, dispute or controversy may arise relating to this Agreement or to the breach, termination, enforcement, interpretation or validity of this Agreement (a “Dispute”). Subject to Section 3.2(c), any Dispute, including Disputes that may involve the Affiliates of any Party, shall be resolved in accordance with this ARTICLE 14.

  • Continuance of Rights and Obligations during Pendency of Dispute Resolution. If there are any Disputes, including Disputes related to termination of this Agreement under ARTICLE 13, all rights and obligations of the Parties shall continue until such time as any Dispute has been resolved in accordance with the provisions of this ARTICLE 14.

  • Escalation. Except as provided otherwise in this Agreement, any Dispute shall be referred to [***] for attempted resolution. In the event [***] are unable to resolve such Dispute within [***] days of such Dispute being referred to them, then, upon the written request of either Party to the other Party, the Dispute shall be subject to arbitration in accordance with Section 14.4.

  • Arbitration.

  • If the Parties fail to resolve the Dispute through escalation to [***] under Section 14.3, and a Party desires to pursue resolution of the Dispute, the Dispute shall be submitted for final resolution by arbitration under the Rules of Arbitration of the International Chamber of Commerce (“ICC Rules”), in effect at the time of the commencement of arbitration, except as modified herein. Any disputes concerning the propriety of the commencement of the arbitration or the scope or applicability of this Agreement to arbitrate shall be finally settled by the arbitral tribunal. The arbitration shall be conducted by a tribunal of three (3) arbitrators, each with at least [***] years of pharmaceutical industry experience. An arbitrator shall be deemed to meet this qualification unless a Party objects within [***] days after the arbitrator is nominated. Within [***] days after initiation of arbitration, each Party shall nominate one (1) arbitrator and the two (2) Party-nominated arbitrators shall nominate a third arbitrator, who shall serve as the chairperson of the tribunal, within [***] days of the second arbitrator’s appointment. If any of the three (3) arbitrators are not nominated within the time prescribed above, then the ICC shall appoint the arbitrator(s). The seat of arbitration shall be [***] and the language of the proceedings, including all communications, shall be English.

  • The Parties agree that any award or decision made by the arbitral tribunal shall be final and binding upon them and may be enforced in the same manner as a judgment or order of a court of competent jurisdiction, and the Parties undertake to carry out any award without delay. The arbitral tribunal shall render its final award or decision within [***] months from the date on which the arbitration file is transmitted to the arbitral

  • tribunal. The arbitral tribunal shall resolve the Dispute by applying the provisions of this Agreement and the governing law set forth in Section 15.6. Notwithstanding Section 15.6 with respect to the applicable governing law, the arbitration and this agreement to arbitrate shall be governed by the Federal Arbitration Act, 9 U.S.C. §§ 1 et seq. No award or procedural order in the arbitration shall be published.

  • By agreeing to arbitration, the Parties do not intend to deprive any court of its jurisdiction to issue, at the request of a Party, a pre-arbitral injunction, pre-arbitral attachment or other order to avoid irreparable harm, maintain the status quo, preserve the subject matter of the Dispute, or aid the arbitration proceedings and the enforcement of any award. Without prejudice to such provisional or interim remedies in aid of arbitration as may be available under the jurisdiction of a competent court, the arbitral tribunal shall have full authority to grant provisional or interim remedies and to award damages for the failure of any Party to the dispute to respect the arbitral tribunal’s order to that effect.

  • EACH PARTY HERETO WAIVES ITS RIGHT TO TRIAL OF ANY ISSUE BY JURY.

  • The arbitrators will be authorized to award compensatory damages, but will not be authorized to (i) award non-economic damages, (ii) award punitive damages or any other damages expressly excluded under this Agreement, or (iii) reform, modify or materially change this Agreement or any other agreements contemplated hereunder; provided, however, that the damage limitations described in clauses (i) and (ii) will not apply if such damages are statutorily imposed. Each Party shall bear its own attorney’s fees, costs, and disbursements arising out of the arbitration, and shall pay an equal share of the fees and costs of the administrator and the arbitrators; provided, however, that the arbitrators shall be authorized to determine whether a Party is the prevailing Party, and if so, to award to that prevailing Party reimbursement for any or all of its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges, travel expenses, etc.), or the fees and costs of the administrator and the arbitrators.

  • Notwithstanding anything in this Section 14.4, in the event of a Dispute with respect to [***], such Dispute shall not be submitted to arbitration in accordance with this Section 14.4, unless otherwise agreed by the Parties in writing, and instead, either Party may initiate litigation in a court of competent jurisdiction in any country in which such rights apply.

  • Miscellaneous

  • Cooperation. In connection with any formal or informal inquiry, investigation or request for information from a Governmental Authority relating to the transactions contemplated by this Agreement, each Party shall use its reasonable best efforts to (a) cooperate with each other, (b) respond promptly to any Governmental Authority requesting information, (c) promptly keep the other Party or its counsel informed regarding any such inquiry, investigation or request, and provide copies of any communication received from or given to the Governmental Authority, relating to the transactions contemplated by this Agreement, (d) consult with each other in advance of any meeting or telephone or video conference with the Governmental Authority under applicable Antitrust Laws, and, to the extent not prohibited by the Governmental Authority, give the other Party or its counsel the opportunity to attend and participate in such meetings and telephone or video conferences, and (e) permit the other Party or its counsel to review in advance, and in good faith consider the views of the other Party or its counsel concerning, any submission, filing or communication (and documents submitted therewith) intended to be given a Governmental Authority.

  • Force Majeure. Neither Party shall be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement (other than any obligation to make payment when due) to the extent such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party including embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods, pandemics, epidemics or other acts of God or any other deity (or orders of any Governmental Authority related to any of the foregoing), or acts, omissions or delays in acting by any Governmental Authority. The affected Party shall notify the other Party of such force majeure circumstances as soon as reasonably practicable, the JDC shall review and discuss any such matter to the extent related to any Clinical Trials in the Territory, and the affected Party shall promptly undertake all reasonable efforts necessary to cure such force majeure circumstances.

  • Assignment. Neither Party may assign this Agreement to a Third Party without the other Party’s prior written consent (such consent not to be unreasonably withheld); except that (a) either Party may make such an assignment without the other Party’s prior written consent to a successor to substantially all of the business of such Party to which this Agreement relates (whether by merger, sale of stock, sale of assets, exclusive license or other transaction), and (b) either Party may assign this Agreement to an Affiliate without the other Party’s prior written consent for so long as such Affiliate remains an Affiliate of the Party making the assignment. For clarity, each Party may discharge any obligations and exercise any right hereunder through any of its Affiliates and each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. This Agreement shall inure to the benefit of and be binding on the Parties’ successors and permitted assignees. Any assignment or transfer in violation of this Section ‎15.3 shall be null and void and wholly invalid, the assignee or transferee in any such assignment or transfer shall acquire no rights whatsoever, and the non-assigning non-transferring Party shall not recognize, nor shall it be required to recognize, such assignment or transfer.

  • Severability. If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The

  • Notices. All notices which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:

If to Kura:

Kura Oncology, Inc.

Address: 12730 High Bluff Drive, Suite 400, San Diego, CA 92130, USA

Attn: Chief Executive Officer

[***]

with a copy to:

Cooley LLP

Address: 10265 Science Center Drive, San Diego, CA 92121, USA

Attn: [***]

[***]

If to KKUS, KKJP or KKC:

Kyowa Kirin Co., Ltd.

Address: 1-9-2 Otemachi, Chiyoda-ku, Tokyo 100-0004, Japan

Attn: Head of Business Development Department

[***]

with a copy to:

Kyowa Kirin Co., Ltd.

Address: 1-9-2 Otemachi, Chiyoda-ku, Tokyo 100-0004, Japan

Attn: Head of Legal Department

or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given: (a) when delivered if personally delivered; (b) if sent by email, upon electronic confirmation of receipt (other than by out-of-office or other automated means); (c) on the Business Day after dispatch if sent by nationally-recognized overnight courier; or (d) on the fifth Business Day following the date of mailing if sent by mail.

  • Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New York, U.S. without reference to any rules of conflict of laws; provided that all questions concerning (a) inventorship and ownership of Patents under this Agreement shall be determined in accordance with Section 12.1(b) and (b) the construction or effect of Patents, including issues relating to the validity, scope or enforceability of any Patent, shall be determined in accordance with the laws of the country or other jurisdiction in which the particular

  • Patent has been filed or granted, as the case may be. The United Nations Convention on Contracts for the International Sale of Goods does not apply to this Agreement and is expressly and entirely excluded.

  • Entire Agreement; Amendments. The Agreement contains the entire understanding of the Parties with respect to the subject matter hereof. All express or implied agreements and understandings, either oral or written (including the Confidentiality Agreement and the Non-Binding Proposal and Draft Term Sheet for Collaboration on Ziftomenib), with regard to the subject matter hereof (including the licenses granted hereunder) are superseded by the terms of this Agreement. Neither Party is relying on any representation, promise, nor warranty not expressly set forth in this Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of both Parties hereto.

  • Headings. The captions to the several Sections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the Sections of this Agreement.

  • Independent Contractors. It is expressly agreed that Kura, on the one hand, and KKC, on the other hand, shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency, including for all tax purposes other than with respect to the Intended Tax Treatment. All individuals employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such first Party.

  • Third Party Beneficiary. The Parties hereby acknowledge and agree that MSK is an intended Third Party beneficiary of this Agreement and that each of the following provisions are for the benefit of MSK and are enforceable by MSK in its own name: Section 2.12(a)(ii), Section 4.14(c), Section 6.5, Section 10.10, Section 11.1 and Section 11.9, and ARTICLE 9 (solely with respect to Kura’s Confidential Information that was first disclosed to Kura by or on behalf of MSK under the MSK License).

  • Waiver. The waiver by either Party of any right hereunder, or the failure of the other Party to perform, or a breach by the other Party, shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise.

  • Waiver of Rule of Construction. Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply.

  • Construction. Except where the context expressly requires otherwise, (a) the use of any gender herein shall be deemed to encompass references to either or both genders, and the use of the singular shall be deemed to include the plural (and vice versa), (b) the words “include”, “includes” and “including” shall be deemed to be followed by the phrase “without limitation”, (c) the word “will” shall be construed to have the same meaning and effect as the word “shall”, (d) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein), (e) any reference herein to any Person shall be construed to include the Person’s successors and assigns, (f) the words “herein”, “hereof” and “hereunder”, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular

  • provision hereof, (g) all references herein to Sections or Schedules shall be construed to refer to Sections or Schedules as described in this Agreement, (h) the word “notice” means notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement, (i) provisions that require that a Party, the Parties or any Committee hereunder “agree”, “consent” or “approve” or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but excluding e-mail and instant messaging), (j) references to any specific law, rule or regulation, or Section, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof, and (k) the term “or” shall be interpreted in the inclusive sense commonly associated with the term “and/or” where applicable.

  • Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Each Party shall be entitled to rely on the delivery of executed electronic copies of counterpart execution pages of this Agreement and such electronic copies shall be legally effective to create a valid and binding agreement among the Parties; provided that the Parties shall promptly exchange the signed original (“wet ink”) hard copies of this Agreement, which shall be deemed an original thereafter.

  • Language. This Agreement is in the English language only, which language shall be controlling in all respects, and all versions hereof in any other language shall be for accommodation only and shall not be binding upon the Parties. All communications and notices to be made or given pursuant to this Agreement, and any dispute proceeding related to or arising hereunder, shall be in the English language. If there is a discrepancy between any translation of this Agreement and this Agreement, this Agreement shall prevail.

[Signature Page Follows]

IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.

Kura Oncology, Inc. Kyowa Kirin Co., Ltd.
By: /s/ Troy Wilson By: /s/ Masashi Miyamoto
Name: Troy Wilson Name: Masashi Miyamoto
Title: President and CEO Title: President and CEO
Kyowa Kirin, Inc.
By: /s/ Steve Schaefer
Name: Steve Schaefer
Title: President, North America

[Signature Page to Collaboration and License Agreement]

Schedule 1.55

Structure of Ziftomenib

[***]

Schedule 1.98

Existing Upstream Agreements

Michigan License

MSK License

Schedule 1.175

Kura Patents

[***]

Schedule 1.204

Baseball Arbitration Procedures

[***].

Schedule 1.304

Ziftomenib Composition Patents

[***]

Schedule 3.2(c)

Expedited Arbitration

[***]

Schedule 4.2(A)

Kura-Specific Development Activities

[***]

Schedule 4.2(B)

Initial Development Plan and Budget

[***]

Schedule 5.2

Initial Startup Budget for Commercialization Activities

[***]

Schedule 5.5

Principles for Co-Promotion Agreement

[***]

Schedule 7.1(b)

Initial Product Transfer

[***]

Schedule 8.9(c)

Form of Invoice – Kura to KKUS

[***]

Form of Invoice – Kura to KKJP

[***]

Schedule 8.13

Tax Appendix

[***]

Schedule 9.5

Joint Press Release

img254414059_0.jpgimg254414059_1.jpg

Kura Oncology and Kyowa Kirin Announce Global Strategic Collaboration to Develop and Commercialize Ziftomenib in Acute Leukemias

– Kura to receive a $330 million upfront payment and up to $1.2 billion in total milestone payments, including $420 million in near-term milestone payments and opt-in right for solid tumors –

– Companies to jointly develop and commercialize ziftomenib; 50/50 profit share in the U.S.; Kura to lead U.S. development and commercial activities and book sales; Kyowa Kirin has exclusive commercialization rights outside the U.S. –

– Companies to jointly pursue broad development program targeting acute leukemias, including frontline indications, combinations with targeted therapies and post-transplant maintenance setting –

– Kura anticipates collaboration funding along with current cash balance to support AML program advances through commercialization in frontline combination therapy –

SAN DIEGO and TOKYO, Nov. 20 and 21, 2024 – Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced they have entered into a global strategic collaboration to develop and commercialize ziftomenib, Kura’s selective oral menin inhibitor, being investigated for the treatment of patients with acute myeloid leukemia (AML) and other hematologic malignancies.

Under the terms of the agreement, Kura will receive an upfront payment of $330 million and expects to receive up to $420 million in near-term milestone payments, including a payment upon the launch of ziftomenib in the monotherapy relapsed/refractory (R/R) setting. In addition, Kura is eligible to receive additional development, regulatory and commercial milestone payments of $741 million, totaling up to $1.161 billion in payments for milestones and the opt-in for solid tumor indications.

In the U.S., Kura will lead development, regulatory and commercial strategy and be responsible for manufacturing ziftomenib. The companies will jointly perform commercialization activities in accordance with a co-created U.S. territory commercialization plan and will share equally in any potential profits and losses.

Outside the U.S., Kyowa Kirin will lead development, regulatory and commercial strategy and is responsible for commercializing ziftomenib. Kura will be eligible to receive tiered double-digit royalties on net product sales.

As a Japan based global specialty pharmaceutical company, Kyowa Kirin aims to create treatments with life-changing value that bring smiles to people living with disease. The company will leverage its hemato-oncology experience and capabilities, and its deep commitment to partnerships, to successfully bring ziftomenib to market globally.

“We believe that ziftomenib is a very promising investigational treatment for genetically defined AML patients,” said Yasuo Fujii, MBA, Chief Strategy Officer, Managing Executive Officer of Kyowa Kirin. “The addition of ziftomenib will complement Kyowa Kirin’s existing hemato-oncology portfolio and pipeline and expand our clinical development efforts into combination therapies designed to generate improved outcomes for cancer patients. We look forward to collaborating closely with the team at Kura and adding ziftomenib to our portfolio of oncology candidates as part of our commitment to bringing new, advanced treatment options to patients and the clinical community around the world.”

Ziftomenib is the first and only investigational therapy to receive breakthrough designation from the U.S. Food and Drug Administration (FDA) for the treatment of R/R NPM1-mutant AML, a mutation that is associated with poor outcomes,,. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed and the companies anticipate submission of a New Drug Application (NDA) in 2025. Kura is also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. Kura expects to initiate registrational Phase 3 frontline studies in both the fit and unfit frontline AML patient populations in 2025.

“This collaboration is an important step toward fulfilling Kura’s commitment to realizing the promise of precision medicines for the treatment of cancer, and it substantially advances our goal of building a sustainable, fully integrated biopharmaceutical company,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “Kyowa Kirin is a wonderful partner for Kura, bringing the expertise and scale of a global pharmaceutical company. On behalf of our leadership team and board of directors, we are thrilled to be working with Kyowa Kirin to realize the potential of ziftomenib as a transformational therapy for AML patients.”

Importantly,” Dr. Wilson continued, “we believe the upfront and anticipated milestone payments from this collaboration combined with our current cash position should provide sufficient funding to support the ziftomenib program to commercialization in the frontline setting, which we believe is a market opportunity of up to $3 billion annually in the U.S. alone.”

Additional Details About the Collaboration

Following regulatory approval, Kura will book sales and take the lead role in U.S. commercial strategy development and both parties will share in commercialization activities. Profits and losses from the commercialization activities will be shared equally in the U.S. Outside the U.S., Kyowa Kirin will lead and perform commercialization activities, book sales and be responsible for the conduct and funding of commercialization of ziftomenib, and Kura is eligible to receive tiered double-digit royalties on net product sales.

As part of the strategic collaboration, the companies will share responsibility for the conduct of clinical trials delineated within an agreed-upon global development plan. For the global development plan, Kura will fund the development costs until the end of 2028, and from 2029 onwards, both companies will share the costs at a 50:50 ratio. The companies will share equally the funding of future trials in the U.S. The agreement includes plans to launch multiple Phase 2 and Phase 3 studies of ziftomenib in AML and other hematologic malignancies over the next several years. Development and commercialization activities under the collaboration will be managed through a shared governance structure.

Under the Agreement, Kyowa Kirin has an option to participate in the development and commercialization of ziftomenib in gastrointestinal stromal tumors (GIST) and other solid tumor indications upon opt-in after receipt of clinical data from the ongoing proof-of-concept study evaluating ziftomenib and imatinib in patients with advanced GIST not successfully treated with imatinib. If Kyowa Kirin exercises its option, Kura is eligible for upfront and milestone payments totaling $228 million and the parties’ roles and responsibilities follow the same structure as the collaboration in AML and other heme malignancies. Excluded from the collaboration are Kura’s ongoing efforts to advance multiple, next-generation menin inhibitor drug candidates targeting certain oncology indications, as well as diabetes and other metabolic diseases.

Kura was advised in the transaction by BofA Securities and represented by Cooley LLP.

Conference Call

Kura will host a webcast and conference call featuring management from both companies at 5:30 pm ET today, November 20, 2024. The live call may be accessed by dialing (800) 715-9871 for domestic callers and (646) 307-1963 for international callers and entering the conference ID: 6978447. A live webcast will be available here and in the Investors section of Kura’s website, with an archived replay available shortly after the event.

About Ziftomenib

Ziftomenib is a selective and oral menin inhibitor currently in development for the treatment of genetically defined AML patients with high unmet need. In April 2024, ziftomenib received Breakthrough Therapy Designation (BTD) by the FDA for the treatment of R/R NPM1-mutant AML based on data from Kura’s ongoing KOMET-001

clinical trial. Additional information about clinical trials for ziftomenib can be found at kuraoncology.com/clinical-trials/#ziftomenib.

About Kura Oncology

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates that target cancer signaling pathways. Ziftomenib, a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction, has received BTD for the treatment of R/R NPM1-mutant AML. Kura has completed enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML (KOMET-001). The Company is also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. Kura is evaluating KO-2806, a next-generation farnesyl transferase inhibitor (FTI), in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies (FIT-001). Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma (KURRENT-HN). For additional information, please visit Kura’s website at www.kuraoncology.com and follow us on X and LinkedIn.

About Kyowa Kirin

Kyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, Kyowa Kirin has invested in drug discovery and biotechnology innovation for more than 70 years and is currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hematology and rare diseases. A shared commitment to Kyowa Kirin’s values, to sustainable growth, and to making people smile unites Kyowa Kirin across the globe. You can learn more about the business of Kyowa Kirin at www.kyowakirin.com.

Kura Forward-Looking Statements

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, Kura’s potential receipt of milestone payments and tiered double-digit royalties under the collaboration; the pursuit of a broad ziftomenib development program including frontline indications, combinations with targeted therapies and post-transplant maintenance setting; Kura’s ability to fund its AML program to commercialization in frontline combinations through the collaboration plus its current cash balance; the efficacy, safety and therapeutic potential of ziftomenib, potential benefits of combining ziftomenib with appropriate standards of care, and progress and expected timing of the ziftomenib program and clinical trials, including the timing of submission of an NDA and initiation of registrational Phase 3 frontline studies; the market opportunity of ziftomenib in the frontline setting; plans to launch multiple Phase

2 and Phase 3 studies of ziftomenib in AML and other hematologic malignancies over the next several years; and Kura’s potential receipt of additional upfront and milestone payments If KKC exercises its option. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, applications and other interactions with regulatory bodies, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, the risk that the collaboration is unsuccessful, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company’s periodic and other filings with the Securities and Exchange Commission (SEC), including the Company’s Form 10-Q for the quarter ended September 30, 2024 filed with the SEC on November 7, 2024, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Kura Contacts

Investors: Pete De Spain Executive Vice President, Investor Relations & Corporate Communications (858) 500-8833 pete@kuraoncology.com

Media: Cassidy McClain

Vice President

Inizio Evoke Comms

(619) 849-6009

cassidy.mcclain@inizioevoke.com

Kyowa Kirin Contacts

Wataru Suzuki Corporate Communications Department – Global media@kyowakirin.com

Lauren Walrath Vice President, Public Affairs – North America lauren.walrath.g4@kyowakirin.com

Schedule 10.2

[***]

Schedule 12.11

Kura Product Marks

[***]

EX-10.33

Exhibit 10.33

WITHOUT PREJUDICE AND SUBJECT TO CONTRACT

SETTLEMENT AGREEMENT

THIS AGREEMENT is made on January 1, 2025

BETWEEN:

  • KURA ONCOLOGY, INC. (the "Company"); and
  • STEPHEN DALE (the "Executive").

BACKGROUND:

  • The Executive is employed by the Company on the terms of their Employment Agreement as Chief Medical Officer.
  • The Executive wishes to resign from his employment with the Company to focus on his health and recovery.
  • The parties have agreed to mutually end the employment relationship and have agreed terms of settlement as set out in this Agreement.
  • The Company is entering into this Agreement for itself and as agent for all Group Companies and is duly authorised in that behalf.
  • It is agreed as follows:
  • Definitions and Interpretation
  • In this Agreement, unless the context otherwise requires, the following definitions shall apply:
  • "Adviser" means the individual named in Schedule 1.
  • "Agreement" means this agreement (including any schedule or annexure to it and any document in agreed form).
  • "Board" means the board of directors of the Company.
  • "Confidential Information" has the meaning given to Proprietary Information in the PIIA.

"Employment Agreement" means the executive employment agreement between the Executive and the Company dated 22 July 2020 (as amended).

  • “Equity Award” has the meaning given in clause 8.1.

  • "ERA" means the Employment Rights Act 1996 (as amended).

  • "Group Company" means the Company and any holding company or any parent company or any subsidiary or subsidiary undertaking of the Company or such companies, as such terms are defined in s 1159, s 1162 (together with Schedule 7 and the definition of "parent company"

  • in s 1173), s 1161 and Schedule 6 of the Companies Act 2006, and "Group Company" means any of them and “Group” means all of them.

  • "ITEPA" means the Income Tax (Earnings and Pensions) Act 2003.

  • “Option” means an Equity Award in the form of a Nonstatutory Stock Option (as defined in the Plan).

“PIIA” means the Employee Proprietary Information and Inventions Agreement between the Executive and the Company dated 24 August 2020 (as amended).

“Plan” means the Amended and Restated Kura Oncology, Inc. 2014 Equity Incentive Plan.

  • "Post-Employment Notice Pay" has the meaning given in section 402D of ITEPA.
  • "Proceedings" means any action, claim or proceedings in the Employment Tribunal or any other court against the Company, any other Group Company or any of its or their shareholders, directors, officers, employees, workers, consultants or agents in respect of any of the matters which are the subject of the Executive's warranty under clause 3.5, or are settled under the terms of this Agreement.
  • “Share” means a share of common stock of the Company.
  • “Stock Award Grant Package” means the grant notice and agreement entered into between the Company and the Executive in respect of an Equity Award.
  • "Termination Date" means the date set out in clause 2.1.

"Termination Payment" has the meaning given to it in clause 6.1.

  • “UK Tax Liability” has the meaning given in clause 8.6.

  • In this Agreement, unless the context otherwise requires:

  • a reference to a statute or statutory provision includes:

  • any subordinate legislation (as defined in Section 21(1) Interpretation Act 1978) made under it;

  • any statute or statutory provision which modifies, consolidates, re-enacts or supersedes it;

  • a reference to:

  • a document in "agreed form" are to that document in the form agreed by the parties (or, as the context requires, agreed by the parties to the referenced document);

  • a "person" includes any individual, firm, body corporate, association or partnership, government or state (whether or not having a separate legal personality);

  • "clauses" and "schedules" is to clauses of and schedules to this Agreement;

  • "indemnify" and "indemnifying" any person against any circumstance include indemnifying and keeping them harmless from all actions, claims and proceedings from time to time made against them and all loss or damage and all payments (including fines, penalties and interest, costs or expenses) made or incurred by that person as a consequence of or which would not have arisen but for that circumstance;

  • headings are for convenience only and shall not affect the interpretation of this Agreement.

  • Termination Date and Notice Pay

  • The parties to this Agreement agree that the Executive’s employment with the Company and/or any other Group Company will terminate 2 January 2025 (the “Termination Date”).

  • The Company will pay to the Executive in the next practicable payroll following the Termination Date, subject to the deduction of such income tax and National Insurance contributions as the Company is required by law to deduct, pay in lieu of the Executive's four week contractual notice entitlement which will not be served by the Executive, in the sum of £34,615.08.

  • The parties agree that the amount of the payment in lieu of notice pursuant to clause 2.2 is equal to or exceeds the amount given by the formula in section 402D(1) of ITEPA and, accordingly, believe that the Executive’s Post-Employment Notice Pay is nil.

  • Settlement of Claims

  • The terms of this Agreement have been agreed between the parties without any admission of liability in full and final settlement of the Executive's complaints in respect of unfair dismissal and/or breach of contract (including but not limited to any claim for wrongful dismissal) against the Company, any other Group Company and/or any of its or their shareholders, directors, officers, consultants, agents, employees or workers arising from the Executive’s employment or from the termination thereof.

  • It is the further intention of the parties that this Agreement shall, without any admission of liability by either party, be in full and final settlement of any other claims the Executive has or may in the future have at common law, under domestic or European legislation, or otherwise against the Company, any other Group Company or any of its or their shareholders, directors, officers, consultants, agents, employees or workers arising directly or indirectly from the Executive's employment by the Company, the Executive’s holding of any office and/or the termination of such employment or office holding including without limitation any claim:

  • pursuant to the ERA in respect of unlawful deduction from wages or unlawful receipt of payments from the Executive, a redundancy payment, guarantee payments, protected disclosures, unlawful detriment, breach of the right to time off work, remuneration or alternative work on suspension, maternity, paternity, adoption, parental rights and flexible working and any other rights under the ERA;

  • to have suffered unlawful detriment, or any other claim, under:

  • regulation 7(2) of the Part-time Workers (Prevention of Less Favourable Treatment) Regulations 2000;

  • regulations 27, 31 and 32 of the Transnational Information and Consultation of Employees Regulations 1999;

  • section 23 of the National Minimum Wage Act 1998;

  • arising under regulations 3, 6(2) or 9 of the Fixed-Term Employees (Prevention of Less Favourable Treatment) Regulations 2002;

  • regulation 30 of the Working Time Regulations 1998;

  • regulation 27, 28 and 32 of the Information and Consultation of Employees Regulations 2004;

  • paragraphs 4 and 8 of the Schedule to the Occupational and Personal Pension Schemes (Consultation by Employers and Miscellaneous Amendment) Regulations 2006; sections 55 and 56 of the Pensions Act 2008;

  • of unlawful discrimination, harassment, victimisation, detriment (including personal injury resulting from any such discrimination, harassment, victimisation) on the grounds of, because of, arising from and/or related to:

  • sex, marital or civil partnership status, gender reassignment, pregnancy or maternity under section 120 of the Equality Act 2010 and/or section 63 of the Sex Discrimination Act 1975;

  • race, colour, nationality or ethnic or national origin under section 120 of the Equality Act and/or section 54 of the Race Relations Act 1976;

  • disability under section 120 of the Equality Act and/or section 17A of the Disability Discrimination Act 1995;

  • religion or belief under section 120 of the Equality Act 2010 and/or regulation 28 of the Employment Equality (Religion or Belief) Regulations 2003;

  • sexual orientation under section 120 of the Equality Act 2010 and/or regulation 28 of the Employment Equality (Sexual Orientation) Regulations 2003; and/or

  • age under section 120 of the Equality Act 2010 and/or regulation 36 of the Employment Equality (Age) Regulations 2006,

  • for equality of terms under sections 120 and 127 of the Equality Act 2010 and section 2(1) of the Equal Pay Act 1970;

  • under the National Minimum Wage Act 1998 or any breach of contract claim arising from a failure to pay additional remuneration under sections 17 or 18 of that Act;

  • in respect of the infringement of the statutory employment rights set out in the Trade Union and Labour Relations (Consolidation) Act 1992;

  • under any directly effective provision of the Treaty of Amsterdam or the legislation of the European Union;

  • under the Human Rights Act 1998;

  • in respect of harassment under section 3 of the Protection from Harassment Act 1997; or

  • in respect of any personal injury claims at the date of this Agreement.

  • The waivers in clauses 3.1 and 3.2 will not apply to the following:

  • any claims by the Executive to enforce the terms of this Agreement;

  • claims in respect of personal injury of which the Executive is not aware and could not reasonably be expected to be aware at the date of this Agreement; and

  • any claims in relation to the Executive's accrued rights arising out of the Executive's membership of the Company pension scheme.

  • The settlement set out in clauses 3.1 and 3.2 shall include, without limitation, any future claims the Executive may have arising out of the Executive's employment or holding of any office or the termination of either, whether or not the matters which give rise to such future claims are currently known to either the Executive, the Company and/or any other Group Company and whether or not any legal remedy available for such claims in the future would be available for an action taken at the date of this Agreement.

  • The Executive, having taken independent legal advice, warrants that, except for any claim expressly set out or referred to in clause 3.1 and without prejudice to clause 3.2, they have no claims whatsoever against the Company, any other Group Company or any of its or their shareholders, directors, officers, consultants, agents, employees or workers arising directly or indirectly from their employment by the Company, their holding of any office and/or the termination of such employment or office holding. The Executive further warrants that they will not bring any claim under, in relation to, arising from and/or in connection with the Equality Act 2010.

  • If the Executive commences any Proceedings, they will repay to the Company immediately upon demand the lesser of the Termination Payment or such amount of the Termination Payment as shall be equivalent to the total amount of any compensation or damages (including interest) awarded and, regardless of how such Proceedings conclude, the full amount of any legal fees incurred by the Company or any other Group Company in defending Proceedings. Any payment to the Executive which remains outstanding under the terms of this Agreement shall cease to be payable with effect from the date of commencement of Proceedings.

  • Pay and Benefits

  • The Company will pay to the Executive through normal payroll, subject to the deduction of such income tax and National Insurance contributions as the Company is required by law to deduct:

  • salary accrued to the Termination Date; and

  • holiday pay in lieu of any accrued but unused pro rata entitlement to 20 days holiday calculated as at the Termination Date.

  • The Company will continue to provide to the Executive, up to the Termination Date, all benefits to which the Executive is contractually entitled, subject to the relevant plan/scheme rules, following which such entitlements will cease.

  • The Company agrees to pay to the Executive their bonus in respect of the 2024 financial year of £225,223. Such bonus shall be paid, subject to the deduction of such income tax and National Insurance contributions as the Company is required by law to deduct, on or around 15 February 2025.

  • Aside from the payments and benefits set out in this Agreement, no further payments and/or benefits are payable to the Executive following the Termination Date.

  • Expenses

The Executive will, no later than the Termination Date, notify the Company of the amount of any expenses incurred by the Executive in the performance of their duties prior to the Termination Date which are yet to be reimbursed and will supply the Company with receipts or other documentary evidence of such expenditure. The Company will, within 14 days of receipt of such notification and evidence, reimburse to the Executive the amount of all such expenses wholly, properly and necessarily incurred by them in the course of their duties.

  • Termination Payment

  • Subject to the provisions of this Agreement (including but not limited to clauses 9 and 14 below) the Company shall pay to the Employee £675,000, as compensation for loss of employment (the “Termination Payment”).

  • The Termination Payment shall be paid less all required deductions for tax and National Insurance contributions, and shall be paid in two tranches as follows:

  • The first tranche, amounting to £450,000, will be paid in a lump sum within 14 days of the later to occur of:

  • the date of this Agreement; and

  • receipt by the Company of a letter from the Adviser in the form as set out in Schedule 1 on or around the date of this Agreement.

  • The second tranche, amounting to £225,000, will be paid in six equal instalments on the Company’s normal payroll dates in January 2025, February 2025, March 2025, April 2025, May 2025, and June 2025.

  • The Company makes no warranty as to the taxable status of the Termination Payment and, accordingly, the Employee hereby indemnifies and agrees to keep the Company and all other Group Companies indemnified against any income tax and Employee National Insurance contributions liability (together with all interest, penalties and costs reasonably incurred) which the Company and/or any other Group Company is or may be liable to pay or account for under

  • the PAYE system in respect of the Termination Payment in excess of any deduction made by the Company at source in respect of such liability.

  • Legal Costs

The Company will pay the Executive's reasonable legal costs up to a maximum of £5,000 (plus VAT) incurred in respect of advice received by the Executive as to the terms and effect of this Agreement. Payment of these costs will be made direct to the Adviser subject to the Company's receipt of an invoice addressed to the Executive but marked payable by the Company.

  • Equity Awards
  • The parties acknowledge that the Executive has been granted the following awards under the Plan and pursuant to the terms of each applicable Stock Award Grant Package (the “Equity Awards”, and each an “Equity Award”):
Date of Grant Type of Award Total Number of Parent Shares under Award Exercise Price (if any) (US$)
24 August 2020 Option 200,000 $21.9800
26 January 2021 Option 100,000 $32.8000
26 January 2022 RSU 36,900 N/A
26 January 2022 Option 261,000 $14.1500
16 February 2023 Option 185,000 $11.9900
16 February 2023 RSU 23,125 N/A
31 May 2023 PSU 247,500 N/A
02 January 2024 Option 185,000 $15.3600
  • The Executive acknowledges and agrees that, except in relation to the Equity Awards, the Executive has no other options or rights in respect of any shares of the Company and/or any other Group Company.

  • The Executive acknowledges that, pursuant to the terms of the applicable Stock Award Grant Package and the Plan, those Shares under each Equity Award that have not vested as at the Termination Date shall lapse for no consideration and shall not be exercisable or capable of settlement, as applicable.

  • The Board (or appropriately authorized committee thereof) has exercised its discretion under the Plan to amend the terms of the Optionssuch that, subject to the Executive’s compliance with the terms of this Agreement, effective on and from the Termination Date, the post-termination exercise period applicable to the Options shall be extended so as to expire on 31

  • March 2026, such that the Options may be exercised (to the extent vested as at the Termination Date) up to 31 March 2026 and shall lapse and cease to be exercisable immediately thereafter.

  • The Company and the Executive acknowledge and agree that, save as provided in clause 8.4 above, the Equity Awards shall continue to be governed by the terms of the Plan and the applicable Stock Award Grant Package, including in respect of the applicable expiration date.

  • The Company makes no representations as to the tax treatment of the Equity Awards. In the event that the Company is required to withhold and pay to HMRC any UK income tax and employee National Insurance Contributions, or is required to pay to HMRC any employer National Insurance Contributions ("UK Tax Liability") in connection with the Equity Awards, the Executive hereby authorises the Company to take any of the following actions, at such times as the Company deems necessary: (a) withhold from amounts payable to the Executive an amount equal to any UK Tax Liability; (b) require the Executive to reimburse the Company in cash in an amount equal to the amount any UK Tax Liability; and (c) withhold from the Executive for no consideration Shares with a fair market value (as determined by the Company in its good faith discretion) equal to the amount of any UK Tax Liability. Furthermore, the Executive hereby agrees to indemnify on demand to the fullest extent permitted by law and hold harmless the Company from and against: (i) each and every claim, liability and demand made by HMRC in respect of any UK Tax Liability; and/or (ii) any interest, fines and penalties incurred by the Company in connection with any UK Tax Liability.

  • For the avoidance of doubt the waiver at clauses 3.1 and 3.2 shall not apply to (and nothing in this Agreement shall have the effect of compromising or waiving) any rights or entitlements the Executive may have or will have as a shareholder in any Group Company after the date of this Agreement.

  • Announcement, Confidentiality and Confidential Information

  • The Company will arrange for the release of an external announcement, in the form mutually agreed by the parties set out in Schedule 2, promptly following the execution of this Agreement (the “External Announcement”). The Company will also arrange for an internal announcement, in the form mutually agreed by the parties set out in Schedule 2, to be sent to Company staff promptly following the execution of this Agreement (the “Internal Announcement”).

  • It is a condition of this Agreement that its terms shall remain confidential to the parties. Except as agreed in this Agreement or otherwise required or permitted by law, no statement or comment shall be made by the parties to any third party in relation to the terms or existence of this Agreement, the claims of the Executive settled by its terms and/or the circumstances of the termination of the Executive's employment or officeholding.

  • The Executive will not make, publish or cause to be published any disparaging remarks or derogatory statement concerning the Company, any other Group Company, its or their directors, officers, shareholders, consultants, agents, employees or workers, or any product or service being sold, developed or provided by the Company and/or any other Group Company. The Company will not encourage or condone the making or publishing of any such remarks concerning the Executive.

  • Without prejudice to and concurrently with the confidential information obligations in the PIIA, the Executive shall not at any time disclose to any person or use for the Executive's own purposes or through lack of diligence cause the unauthorised disclosure of any Confidential Information except as authorised or required by law, although this restriction shall not apply to any Confidential Information coming into the public domain other than as a result of any breach by the Executive of this obligation.

  • The Executive warrants that all Confidential Information that the Executive has in their possession, custody or under their control by whom and in whatever format recorded (whether electronically, digitally, on paper, on audio or audio visual tape or otherwise and including all copies) will be returned to the Company as soon as practicable following the Termination Date and that neither the Executive nor any other unauthorised person will retain the ability to access such information.

  • The parties are permitted to make a disclosure or comment that would otherwise be prohibited by this clause 9 where necessary and appropriate:

  • in the Executive’s case, if they make it to:

  • their spouse, civil partner or partner or immediate family provided that such persons agree to keep the information confidential;

  • any person who owes the Executive a duty of confidentiality (which the Executive agrees not to waive) in respect of information the Executive discloses to them, including the Executive’s legal or tax advisers;

  • their insurer for the purposes of processing a claim for loss of employment; or

  • their recruitment consultant or prospective employer to the extent only strictly necessary to discuss the Executive’s employment history,

  • in any Group Company’s case, it is made to:

  • any director, officer or employee whose province it is to know such information provided that they agree to keep the information confidential; or

  • any person who owes a Group Company a duty of confidentiality in respect of information which is disclosed to them, including, legal, tax, compliance or other professional advisers.

  • Nothing in this clause 9 shall prevent the Executive or any Group Company or any of its or their shareholders, directors, officers, employees, workers, consultants or agents from:

  • making a protected disclosure under section 43A of the ERA;

  • reporting a suspected criminal offence to the police or any law enforcement agency or co-operating with the police or any law enforcement agency regarding a criminal investigation or prosecution;

  • doing or saying anything that is required by HMRC or a regulator, ombudsman or supervisory authority;

  • filing, reporting, saying or doing anything that is required by the U.S. Securities and Exchange Commission or its rules (including the public filing of this Agreement in unredacted form);

  • complying with an order from a court or tribunal to disclose or give evidence;

  • disclosing information to HMRC for the purposes of establishing and paying (or recouping) tax and national insurance liabilities arising from the Executive’s employment or its termination; or

  • making any other disclosure as required by law or to comply with any regulatory requirements.

  • Company Property

  • The Executive warrants that all property belonging to the Company or any other Group Company which is/was in their possession or under their control will be returned to the Company in good working order as soon as practicable following the Termination Date.

  • The Executive confirms that they will, as soon as practicable following the Termination Date, irretrievably delete any information relating to the business of the Company and/or any other Group Company (and all matter derived from such information) that is/was stored on any computer or storage media or otherwise in any electronic or digital form outside of the premises of the Company and which is/was in the Executive's possession, custody or control and shall produce such evidence of having done so as the Company may request and/or allow the Company to inspect any such computer or other device.

  • Continuing Obligations

  • The Executive remains bound by any continuing obligations within the Employment Agreement, the PIIA, and any other contractual agreement between the Executive and any Group Company. For the avoidance of doubt, this includes any confidential / proprietary information (without prejudice to the confidential information provisions in this Agreement), intellectual property / inventions / proprietary rights and/or restrictive covenant / non-solicitation provisions in the Employment Agreement and/or the PIIA.

  • The Executive undertakes that they will not, following the Termination Date, hold themselves out or permit themselves to be held out as being employed by, or holding office in, the Company and/or any other Group Company.

  • Reference

  • Subject to the provisions of this clause 12, the Company will provide directly to any prospective employer, upon receipt of a written request to do so, sent to Kelly Cannan (or to such other person as the Company may nominate from time to time), a written reference in the form set out in Schedule 3 to this Agreement.

  • The Company reserves the right to make disclosures concerning the Executive's conduct which come to light after the date of this Agreement in order to comply with the Company's duty of care to the party requesting a reference. If the Company obtains information after the date of

  • this Agreement which would have affected its decision to provide a reference in the form agreed, it shall inform the Executive and may decline to give a reference.

  • The Company reserves the right to make such disclosures concerning the Executive as required by law or to comply with any regulatory requirements.

  • Legal Advice

  • The Executive confirms that:

  • they have received independent legal advice from the Adviser as to the terms and effect of this Agreement including, in particular, its effect on the Executive’s ability to pursue any claim before an Employment Tribunal;

  • the Adviser has advised the Executive that there was in force, when the Adviser gave the advice referred to in paragraph (a), a policy of insurance covering the risk of a claim by the Executive in respect of loss arising in consequence of the advice.

  • It is agreed that the conditions regulating settlement agreements and compromise agreements, as appropriate, under section 147 of the Equality Act 2010, section 77(4A) of the Sex Discrimination Act 1975 (in relation to claims under that Act and the Equal Pay Act 1970), section 72(4A) of the Race Relations Act 1976, paragraph 2 of Schedule 3A to the Disability Discrimination Act 1995, paragraph 2(2) of Schedule 4 to the Employment Equality (Sexual Orientation) Regulations 2003, paragraph 2(2) of Schedule 4 to the Employment Equality (Religion or Belief) Regulations 2003, paragraph 2(2) of Schedule 5 to the Employment Equality (Age) Regulations 2006, section 288(2B) of the Trade Union and Labour Relations (Consolidation) Act 1992, section 203(3) of the Employment Rights Act 1996, regulation 35(3) of the Working Time Regulations 1998, section 49(4) of the National Minimum Wage Act 1998, regulation 41(4) of the Transnational Information and Consultation etc. Regulations 1999, regulation 9 of the Part-Time Workers (Prevention of Less Favourable Treatment) Regulations 2000, regulation 10 of the Fixed-Term Employees (Prevention of Less Favourable Treatment) Regulations 2002, regulation 40(4) of the Information and Consultation of Employees Regulations 2004, paragraph 12 of the Schedule to the Occupational and Personal Pension Schemes (Consultation by Employers and Miscellaneous Amendment) Regulations 2006 and section 58 of the Pensions Act 2008 have been satisfied.

  • By signing and delivering on the date of this Agreement a certificate in the form at Schedule 1 to this Agreement, the Adviser confirms that they have given to the Executive the advice referred to in clause 13.1 and that the conditions regulating settlement agreements and compromise agreements, as appropriate, which are referred to in clause 13.2 have been satisfied. The Adviser further confirms that they are a qualified solicitor holding a current practising certificate and are independent of the Company and/or any other Group Company for whom they have not acted and have no current expectation of activity. At the time that the Adviser gave the advice referred to in clause 13.1, there was in force a contract of insurance covering the risk of a claim by the Executive in respect of any loss arising in consequence of that advice.

  • Warranties

  • The Executive warrants that at the date of this Agreement they are not aware of any facts, matters or circumstances that would reasonably be expected to give rise to:

  • any claim for personal injury by them against the Company or any other Group Company and that there are no such claims pending at the date of this Agreement; and/or

  • a dispute between them and the Company or any other Group Company and/or the pension trustees in respect of their pension rights or a complaint to the Pensions Regulator.

  • The Executive warrants, as a strict condition of this Agreement, that as at the date of this Agreement there are no facts or circumstances of which the Executive is aware or of which the Executive ought reasonably to be aware which would amount to a repudiatory breach by the Executive of any express or implied term of the Employment Agreement or the PIIA which would or would have entitled the Company to terminate the Executive's employment without notice or pay in lieu of notice and any payments or benefits pursuant to this Agreement are subject to and conditional upon this being so.

  • The Executive warrants that they will not submit any grievances to the Company and/or any other Group Company in relation to their employment and/or office holding and/or the termination of their employment or office holding. The Executive further relinquishes and agrees not to pursue either any grievance which may have been raised by them and/or any subject access request outstanding as at the date of this Agreement and that all such grievances and/or requests shall be deemed to have been withdrawn by the Executive as at the date of this Agreement.

  • Third Parties and Variation

  • Save by any Group Company or any director, officer, or employee of any Group Company, no term of this Agreement is enforceable pursuant to the Contracts (Rights of Third Parties) Act 1999 by any person who is not a party to it.

  • No purported variation of this Agreement shall be effective unless it is in writing and signed by or on behalf of each of the parties.

  • Pursuant to Section 2(3)(a) Contracts (Rights of Third Parties) Act 1999, the parties, in accordance with clause 15.1, may without limit or restriction and without the consent of any third party:

  • vary this Agreement or any provision of it which may be enforced by any third party or otherwise amend this Agreement in such a way as to extinguish or alter any third party's entitlement under any such provisions; and/or

  • rescind this Agreement.

  • Counterparts

This Agreement may be executed in any number of counterparts, each of which, when executed and delivered, shall be an original, and all the counterparts together shall constitute one and the same instrument.

  • Entire Agreement and Conflicts
  • This Agreement sets out the entire agreement and understanding between the parties and supersedes all prior agreements, understanding or arrangements (whether oral or written) in respect of the subject matter of this Agreement.
  • The Executive acknowledges that they have entered into this Agreement in reliance only on the representations, warranties and promises specifically contained or incorporated in this Agreement and, save as expressly set out in this Agreement, neither the Company, nor any other Group Company nor any of its or their employees, officers or agents shall have any liability in respect of any other representation, warranty or promise made prior to the date of this Agreement unless it was made fraudulently.
  • Severability

The unenforceability of any provision of this Agreement shall not affect the enforceability of all remaining provisions. It is agreed that each obligation under this Agreement is separate and severable and any such unenforceable provision shall not be deemed to be part of this Agreement.

  • Governing Law and Jurisdiction

This Agreement shall be governed by and construed in all respects in accordance with the laws of England and Wales and each of the parties irrevocably submits to the exclusive jurisdiction of the courts of England and Wales.

  • Effective Date

This Agreement will come into effect on the date of the last party's signature on which date the "without prejudice and subject to contract" nature of this Agreement will cease to apply.

Signed by
/s/ Stephen Dale
Stephen Dale
Date: 01 January 2025
Signed by
---
/s/ Troy Wilson, Ph.D, J.D.<br><br>Troy Wilson, Ph.D, J.D.
For and on behalf of Kura Oncology, Inc.
Date: 01 January 2025

EX-10.34

Exhibit 10.34

Kura Oncology, Inc.

Third Amended & Restated Executive Employment Agreement for

MOLLIE LEONI

This Third Amended & Restated Executive Employment Agreement (the “Agreement”), entered into between Kura Oncology, Inc. (the “Company”) and MOLLIE LEONI (the “Executive”) (collectively, the “Parties”), is effective as of January 2, 2025.

Whereas, Executive has been employed by the Company as executive vice president, clinical development, pursuant to an Amended & Restated Executive Employment Agreement, dated March 23, 2023 (the “Original Agreement”);

Whereas, the Company desires Executive to provide employment services to the Company as chief medical officer, and wishes to provide Executive with certain compensation and benefits in return for such employment services; and

Whereas, Executive wishes to be employed by the Company as chief medical officer

and to provide personal services to the Company in return for certain compensation and benefits.

Now, Therefore, in consideration of the mutual promises and covenants contained herein and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereto agree as follows:

  • Employment by the Company.

  • Position. Effective upon the Effective Date, Executive will serve as the CHIEF MEDICAL OFFICER of the Company. 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, except for approved vacation periods and reasonable periods of illness or other incapacities permitted by the Company’s general employment policies.

  • Duties and Location. Executive will perform such duties as are required by the Company’s Chief Executive Officer1, to whom Executive will report. Executive’s primary office location will be the Company’s Boston, MA office. The Company reserves the right to reasonably require Executive to perform Executive’s duties at places other than Executive’s primary office location from time to time, and to require reasonable business travel. The Company may modify Executive’s job title and duties as it deems necessary and appropriate in light of the Company’s needs and interests from time to time.

  • Policies and Procedures. The employment relationship between the Parties will be governed by the general employment policies and practices of the Company, except that when the terms of this Agreement differ from or are in conflict with the Company’s general employment policies or practices, this Agreement will control.

  • Compensation.

  • Salary. For services to be rendered hereunder, Executive will receive a base

salary at the rate of $512,200 per year (the “Base Salary”) payable in installments in accordance with the Company’s regular payroll schedule.

  • Bonus. Executive will be eligible for an annual discretionary bonus of up to 40% of Executive’s Base Salary (the “Annual Bonus”). Whether Executive receives an Annual Bonus for any given year, and the amount of any such Annual Bonus, will be determined by the Company’s Board of Directors (“Board”) in its sole discretion based upon the Company’s and Executive’s achievement of objectives and milestones to be determined on an annual basis by the Board. Executive must remain an active employee through the end of any given calendar year in order to earn an Annual Bonus for that year and any such bonus will be paid prior to March 15 of the year following the year in which such bonus was earned. Executive will not be eligible for, and will not earn, any Annual Bonus (including a prorated bonus) if Executive’s employment terminates for any reason before the end of the calendar year.

  • Equity. Pursuant to the Company’s Amended and Restated 2014 Equity Incentive Plan (as amended from time to time, the “Plan”), as further consideration for Executive’s continued employment under the terms of this Agreement, the Company granted Executive an option to purchase 92,500 shares of the Company’s common stock (“Common Stock”) on January 2, 2025 (the “Option”). The Option is subject to the terms and conditions of the Plan and Executive’s option agreement. The Option is subject to vesting over a four (4) year period according to the following schedule: 1/48th of the shares will vest on a monthly basis, so long as Executive remains in continuous service with the Company through the applicable vesting dates.

  • Standard Company Benefits. Executive shall be entitled to participate in all employee benefit programs for which Executive is eligible under the terms and conditions of the benefit plans that may be in effect from time to time and provided by the Company to its employees. The Company reserves the right to cancel or change the benefit plans or programs it offers to its employees at any time.

  • PAID TIME OFF. Executive will be entitled to accrue and use paid time off in accordance with the terms of the Company’s paid time off policy and practices, provided, however, that in no event will Executive’s paid time off accrual rate be lower than four (4) weeks per year.

  • EXPENSES. The Company will reimburse Executive for reasonable travel, entertainment or other expenses incurred by Executive in furtherance or in connection with the performance of Executive’s duties hereunder, in accordance with the Company’s expense reimbursement policy as in effect from time to time.

  • Termination of Employment; Severance.

  • At-Will Employment. Executive’s employment relationship is at-will. Either Executive or the Company may terminate the employment relationship at any time, with or without Cause or advance notice.

  • Termination Without Cause; Resignation for Good Reason.

  • Not in Connection with a Corporate Transaction. In the event Executive’s employment with the Company is terminated by the Company without Cause (other than by reason of death or disability), or Executive resigns for Good Reason, then provided such termination or resignation constitutes a “separation from service” (as defined under Treasury

Regulation Section 1.409A-1(h), without regard to any alternative definition thereunder, a “Separation from Service”), the Separation from Service occurs more than 59 days prior to or 12 months after the closing of a Corporate Transaction, the Company shall pay Executive’s base salary and accrued and unused vacation benefits earned through the date of termination, at the rate in effect at the time of termination, less standard deductions and withholdings. In addition, if Executive provides a signed release of claims in a form reasonably satisfactory to the Company (the “Release”) and allows such Release to become irrevocable and effective no later than 60 days following Executive’s Separation from Service, and provided that Executive remains in compliance with the terms of this Agreement and the Confidentiality Agreement (as defined below), the Company will provide Executive with the following severance benefits:

  • A cash lump-sum payment in an amount equal to twelve

(12) months of Executive’s annual base salary at the rate in effect on the effective date of Executive’s Separation from Service, ignoring any decrease in base salary that forms the basis for Good Reason, less standard deductions and withholdings, payable on the 60th day following Executive’s Separation from Service.

  • Provided Executive timely elects continued coverage under the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“COBRA”), the Company will pay the COBRA premiums to continue Executive’s coverage (including coverage for eligible dependents, if applicable), subject to withholding if deemed necessary to comply with applicable laws, through the period (the “COBRA Premium Period”) starting on the Executive’s Separation from Service and ending on the earliest to occur of: (A) twelve (12) months following Executive’s Separation from Service; (B) the date Executive becomes eligible for group health insurance coverage through a new employer; or (C) the date Executive ceases to be eligible for COBRA continuation coverage for any reason. In the event Executive becomes covered under another employer's group health plan or otherwise ceases to be eligible for COBRA during the COBRA Premium Period, Executive must immediately notify the Company of such event.
  • In Connection with a Corporate Transaction. In the event Executive’s employment with the Company is terminated by the Company without Cause (other than by reason of death or disability), or Executive resigns for Good Reason, and provided such termination or resignation constitutes a Separation from Service and such the Separation from Service occurs within 59 days prior to, on or within 12 months following the closing of a Corporate Transaction, the Company shall pay Executive’s base salary and accrued and unused vacation benefits earned through the date of termination, at the rate in effect at the time of termination, less standard deductions and withholdings. In addition, if Executive provides a signed Release and allows such Release to become irrevocable and effective no later than 60 days following Executive’s Separation from Service, and provided that Executive remains in compliance with the terms of this Agreement and the Confidentiality Agreement, the Company will provide Executive with the following severance benefits:
  • A cash lump-sum payment in an amount equal to twelve

(12) months of Executive’s annual base salary at the rate in effect on the effective date of Executive’s Separation from Service, ignoring any decrease in base salary that forms the basis for Good Reason, less standard deductions and withholdings, payable on the 60th day following Executive’s Separation from Service.

  • A cash lump-sum payment in an amount equal to the Executive’s full target bonus amount for services to be performed during the year in which the Corporate Transaction occurs, less standard deductions and withholdings, payable on the 60th day following Executive’s Separation from Service.
  • Provided Executive timely elects continued coverage under COBRA, the Company will pay the COBRA premiums to continue Executive’s coverage (including coverage for eligible dependents, if applicable), subject to withholding if deemed necessary to comply with applicable laws, through the COBRA Premium Period. In the event Executive becomes covered under another employer’s group health plan or otherwise ceases to be eligible for COBRA during the COBRA Premium Period, Executive must immediately notify the Company of such event.
  • One hundred percent of any equity held by Executive will be deemed vested and exercisable (if applicable) as of Executive’s last day of employment, provided, however, that with respect to any performance based vesting equity awards held by Executive that have multiple vesting levels depending upon the level of performance, such equity awards will vest at the target level.
  • COBRA. Notwithstanding Sections 6.2(a)(ii) and 6.2(b)(iii), if the Company determines, in its sole discretion, that the Company cannot provide the COBRA premium benefits without potentially incurring financial costs or penalties under applicable law (including, without limitation, Section 2716 of the Public Health Service Act), the Company shall in lieu thereof pay Executive a taxable cash amount, which payment shall be made regardless of whether the Executive or the Executive’s qualifying family members elect COBRA continuation coverage (the “Health Care Benefit Payment”). The Health Care Benefit Payment shall be paid in monthly or bi- weekly installments on the same schedule that the COBRA premiums would otherwise have been paid to the insurer. The Health Care Benefit Payment shall be equal to the amount that the Company otherwise would have paid for COBRA insurance premiums (which amount shall be calculated based on the premium for the first month of coverage), and shall be paid until the expiration of the COBRA Premium Period, but determined without regard to whether or not the Executive continues to be eligible for COBRA coverage.
  • Resignation Without Good Reason; Termination for Cause; Death or Disability. If Executive resigns without Good Reason, or the Company terminates Executive’s service for Cause, or upon a termination due to Executive’s death or disability, then all payments of compensation by the Company to Executive hereunder will terminate immediately (except as to amounts already earned), and Executive will not be entitled to any severance benefits under Section 6.2(a) or Section 6.2(b).
  • Section 280G.
  • If any payment or benefit Executive would receive from the Company or otherwise (“Payment”) would (i) constitute a “parachute payment” within the meaning of Section 280G of the Code, and (ii) but for this sentence, be subject to the excise tax imposed by Section 4999 of the Code (the “Excise Tax”), then such 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 being subject to the Excise Tax or (y) the largest portion, up to and including the total, of the Payment, whichever amount, 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”). Notwithstanding the foregoing, 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 of the Code that would not otherwise be subject to taxes pursuant to Section 409A of the Code, 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 of the Code 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; (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 of the Code shall be reduced (or eliminated) before Payments that are not deferred compensation within the meaning of Section 409A of the Code.

  • In the event it is subsequently determined by the Internal Revenue Service that some portion of the Reduced Amount as determined pursuant to clause (x) in the preceding paragraph is subject to the Excise Tax, Executive agrees to promptly return to the Company a sufficient amount of the Payment so that no portion of the Reduced Amount is subject to the Excise Tax. For the avoidance of doubt, if the Reduced Amount is determined pursuant to clause (y) in the preceding paragraph, Executive will have no obligation to return any portion of the Payment pursuant to the preceding sentence.
  • Unless Executive and the Company agree on an alternative accounting firm, the accounting firm engaged by the Company for general tax compliance purposes as of the day prior to the effective date of the Corporate 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 Corporate Transaction, the Company shall appoint a nationally recognized accounting firm to make the determinations required hereunder. The Company shall bear all expenses with respect to the determinations by such accounting firm required to be made hereunder.
  • The Company shall use commercially reasonable efforts to cause the accounting 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 Payment is triggered (if requested at that time by Executive or the Company) or such other time as requested by Executive or the Company.
  • SECTION 409A.
  • It is intended that all of the severance benefits and other payments payable under this Agreement satisfy, to the greatest extent possible, the exemptions from the application of Code Section 409A provided under Treasury Regulations 1.409A-1(b)(4), 1.409A-1(b)(5) and 1.409A-1(b)(9), and this Agreement will be construed to the greatest extent possible as consistent with those provisions, and to the extent not so exempt, this Agreement (and any definitions hereunder) will be construed in a manner that complies with Code Section 409A.
  • A termination of employment will not be deemed to have occurred for purposes of any provision of this Agreement providing for the payment of any amounts or benefits upon or following a termination of employment unless such termination is also a Separation from Service and, for purposes of any such provision of this Agreement, references to a “termination,” “termination of service” or like terms will mean Separation from Service. If Executive is deemed on the date of termination to be a “specified employee” within the meaning of that term under Code Section 409A(a)(2)(B), then with regard to any payment or the provision of any benefit that is considered deferred compensation under Code Section 409A payable on account of a Separation from Service, such payment or benefit will be made or provided at the date which is the earlier of

(A) the expiration of the six-month period measured from the date of such Separation from Service of Executive, and (B) the date of Executive’s death, to the extent required under Code Section 409A. Upon the expiration of the foregoing delay period, all payments and benefits delayed pursuant to this Section 8.2 (whether they would have otherwise been payable in a single sum or in installments in the absence of such delay) will be paid or reimbursed to Executive in a lump sum, and any remaining payments and benefits due under this Agreement will be paid or provided in accordance with the normal payment dates specified for them herein.

  • To the extent that reimbursements or other in-kind benefits under this Agreement constitute “nonqualified deferred compensation” for purposes of Code Section 409A, (A) all expenses or other reimbursements hereunder will be made on or prior to the last day of the taxable year following the taxable year in which such expenses were incurred by Executive, (B) any right to reimbursement or in-kind benefits will not be subject to liquidation or exchange for another benefit, and (C) no such reimbursement, expenses eligible for reimbursement, or in-kind benefits provided in any taxable year will in any way affect the expenses eligible for reimbursement, or in-kind benefits to be provided, in any other taxable year.

  • For purposes of Code Section 409A, Executive’s right to receive any installment payments pursuant to this Agreement will be treated as a right to receive a series of separate and distinct payments. Whenever a payment under this Agreement specifies a payment period with reference to a number of days, the actual date of payment within the specified period will be within the sole discretion of the Company. Notwithstanding any other provision of this Agreement to the contrary, in no event will any payment under this Agreement that constitutes “nonqualified deferred compensation” for purposes of Code Section 409A be subject to offset by any other amount unless otherwise permitted by Code Section 409A.

  • Definitions.

  • “Cause” with respect to Executive means Executive has: (a) been convicted of or pled guilty or nolo contendere to a felony or any crime involving moral turpitude or dishonesty;

(b) participated in a fraud or act of dishonesty against the Company; (c) materially breached any agreement between such Executive and the Company or any written policy of the Company, and not cured such breach within five days of the Company’s written notice of such breach; (d) engaged in conduct that demonstrates gross unfitness to serve; or (e) engaged in willful misconduct or refused to comply with any lawful directive of the Company, and not cured such noncompliance within five days of the Company’s written notice of such noncompliance.

  • “Code” means the Internal Revenue Code of 1986, as amended.
  • “Good Reason” will exist for Executive’s resignation from employment with the Company if any of the following actions are taken by the Company without Executive’s prior written consent:
  • a material reduction in Executive’s base salary, unless pursuant to a salary reduction program applicable generally to the Company’s similarly situated employees;
  • a material reduction in Executive’s duties (including responsibilities and/or authorities);
  • a material reduction in the authority, duties, or responsibilities of the supervisor to whom Executive is required to report, including a requirement that Executive report to an employee of the Company instead of the Chief Executive Officer;
  • relocation of Executive’s principal place of employment to a place that increases Executive’s one-way commute by more than 50 miles as compared to Executive’s then-current principal place of employment immediately prior to such relocation; or
  • any other action or inaction that constitutes a material breach by the Company of this Agreement or any agreement under which Executive provides services.

Provided, however that, such termination by the Executive shall only be deemed for Good Reason pursuant to the foregoing definition if (i) the Company is given written notice from the Executive within 30 days following the first occurrence of the condition that Executive considers to constitute Good Reason describing the condition and the Company fails to satisfactorily remedy such condition within 30 days following such written notice, and (ii) the Executive terminates employment within 90 days following the end of the period within which the Company was entitled to remedy the condition constituting Good Reason but failed to do so.

  • “Corporate Transaction” means the consummation, in a single transaction or in a series of related transactions, of any one or more of the following events:
  • a sale, lease or other disposition of all or substantially all, as determined by the Board in its sole discretion, of the consolidated assets of the Company and its subsidiaries;
  • a merger, consolidation, or similar transaction of the Company following which such entity is not the surviving entity;
  • a merger, consolidation or similar transaction of the Company following which such entity is the surviving entity but the shares outstanding immediately preceding the merger, consolidation or similar transaction are converted or exchanged by virtue of the merger consolidation or similar transaction into other property, whether in the form of securities, cash or otherwise.

Notwithstanding the foregoing, the term Corporate Transaction will not include (i) a sale of assets, merger or other transaction effected exclusively for the purpose of changing the domicile of the Company, or (ii) the acquisition of securities of the Company by an investor or any affiliate thereof that acquires the Company’s securities in a transaction or series of related transactions the primary purpose of which is to obtain financing for the Company through the issuance of equity securities. In addition, to the extent required for compliance with Code Section 409A, in no event will an event be deemed a Corporate Transaction if such transaction is not also a “change in the ownership or effective control of” the Company or “a change in the ownership of a substantial portion of the assets of” the Company as determined under Treasury Regulation Section 1.409A-3(i)(5) (without regard to any alternative definition thereunder).

  • Proprietary Information Obligations.

  • Confidential Information Agreement. As a condition of Executive’s continued employment, Executive will continue to abide by the Employee Proprietary Information

and Inventions Agreement3 (the “Confidentiality Agreement”) and Arbitration Agreement4 previously executed by Executive.

  • Third-Party Agreements and Information. Executive represents and warrants that Executive’s employment by the Company does not conflict with any prior employment or consulting agreement or other agreement with any third party, and that Executive will perform Executive’s duties to the Company without violating any such agreement. Executive represents and warrants that Executive does not possess confidential information arising out of prior employment, consulting, or other third party relationships, that would be used in connection with Executive’s employment with the Company, except as expressly authorized by that third party. During Executive’s employment with the Company, Executive will use in the performance of Executive’s duties only information which is generally known and used by persons with training and experience comparable to Executive’s own, common knowledge in the industry, otherwise legally in the public domain, or obtained or developed by the Company or by Executive in the course of Executive’s work for the Company.

  • Outside Activities During Employment.

  • Non-Company Business. Except with the prior written consent of the Chief Executive Officer, Executive will not during the term of Executive’s employment with the Company undertake or engage in any employment, occupation or business enterprise, other than ones in which Executive is a passive investor or as permitted under Section 11.2. Executive shall be entitled to serve on the board of directors of such other companies as may be approved in advance by the Chief Executive Officer, in each case, so long as Executive remain in compliance with this Section 11 and such service does not interfere with Executive’s duties under this Agreement. Executive may engage in civic and not-for-profit activities so long as such activities do not materially interfere with the performance of Executive’s duties hereunder.

  • No Adverse Interests. Except with the prior written consent of the Chief Executive Officer, Executive will not during the term of Executive’s employment with the Company acquire, assume or participate in, directly or indirectly, any position, investment or interest known to be adverse or antagonistic to the Company, its business or prospects, financial or otherwise, provided that this does not prohibit Executive’s continued involvement in any existing investments or ownership, for investment purposes only, of not more than 3% of the outstanding stock of any company listed on a national securities exchange, or actively traded in a national over-the-counter market.

  • NON-SOLICITATION. Executive agrees that, to the extent permitted by applicable law, during the period of employment with the Company and for 12 months after the date Executive’s employment is terminated for any reason, Executive will not, either directly or through others, solicit or encourage or attempt to solicit or encourage any employee, independent contractor, or consultant of the Company to terminate his or her relationship with the Company.

  • General Provisions.

  • Notices. Any notices provided must be in writing and will be deemed effective upon the earlier of personal delivery (including personal delivery by fax) or the next day

after sending by overnight carrier, to the Company at its primary office location and to Executive at the address as listed on the Company payroll.

  • Severability. 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 to the extent possible in keeping with the intent of the parties.
  • Waiver. Any waiver of any breach of any provisions of this Agreement must be in writing to be effective, and it will not thereby be deemed to have waived any preceding or succeeding breach of the same or any other provision of this Agreement.
  • Complete Agreement. This Agreement, together with the Confidentiality Agreement and the Arbitration Agreement, constitute the entire agreement between Executive and the Company with regard to this subject matter and is the complete, final, and exclusive embodiment of the Parties’ agreement with regard to this subject matter. This Agreement is entered into without reliance on any promise or representation, written or oral, other than those expressly contained herein, and it supersedes any other such promises, warranties or representations, including the Original Agreement. Executive agrees and acknowledges that there are no circumstances as of the date of this Agreement that constitute, and nothing contemplated in this Agreement shall be deemed for any purpose to be or to create, an involuntary termination without Cause or a Good Reason resignation right, including for purposes of the Original Agreement, or any other severance or change in control plan, agreement or policy maintained by the Company. Executive further hereby expressly waives any claim or right Executive may have as of the date of this Agreement (if any) to assert that this Agreement, or any other condition or occurrence, forms the basis for a without Cause termination or Good Reason resignation for any purpose, including for purposes of the Original Agreement, or any other severance or change in control plan, agreement or policy maintained by the Company. This Agreement cannot be modified or amended except in a writing signed by a duly authorized officer of the Company.
  • Counterparts. 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.
  • Headings. The headings of the paragraphs hereof are inserted for convenience only and will not be deemed to constitute a part hereof nor to affect the meaning thereof.
  • Successors and Assigns. This Agreement is intended to bind and inure to the benefit of and be enforceable by Executive and the Company, and their respective successors, assigns, heirs, executors and administrators, except that Executive may not assign any of Executive’s duties hereunder and Executive may not assign any of Executive’s rights hereunder without the written consent of the Company, which will not be withheld unreasonably.
  • Choice of Law. All questions concerning the construction, validity and interpretation of this Agreement will be governed by the laws of the Commonwealth of Massachusetts.

[Signature page follows]

9.

In Witness Whereof, the Parties have executed this Agreement on the day and year first written above.

Kura Oncology, Inc.
By: /s/ Troy Wilson, Ph.D., J.D.
Name: Troy Wilson, Ph.D., J.D.<br><br>Title: President and CEO
Executive
---
/s/ Mollie Leoni
Mollie Leoni

EX-10.35

Exhibit 10.35

Kura Oncology, Inc.

third Amended & Restated Executive Employment Agreement for

FRANCIS BURROWS

This Third Amended & Restated Executive Employment Agreement (the “Agreement”), entered into between Kura Oncology, Inc. (the “Company”) and FRANCIS BURROWS (the “Executive”) (collectively, the “Parties”), is effective as of January 2, 2025.

Whereas, Executive has been employed by the Company as senior vice president, translational research, pursuant to an Amended & Restated Executive Employment Agreement, dated January 1, 2023 Effective Date of Current Agreement, as amended (the “Original Agreement”);

WHEREAS, the Company desires Executive to provide employment services to the Company as CHIEF SCIENTIFIC OFFICER, and wishes to provide Executive with certain compensation and benefits in return for such employment services; and

WHEREAS, Executive wishes to be employed by the Company as CHIEF SCIENTIFIC OFFICER and to provide personal services to the Company in return for certain compensation and benefits.

Now, Therefore, in consideration of the mutual promises and covenants contained herein and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereto agree as follows:

  • Employment by the Company.

  • Position. Effective upon the Effective Date, Executive will serve as the CHIEF SCIENTIFIC OFFICER of the Company. 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, except for approved vacation periods and reasonable periods of illness or other incapacities permitted by the Company’s general employment policies.

  • Duties and Location. Executive will perform such duties as are required by the Company’s Chief Executive Officer, to whom Executive will report. Executive’s primary office location will be the Company’s San Diego, CA office. The Company reserves the right to reasonably require Executive to perform Executive’s duties at places other than Executive’s primary office location from time to time, and to require reasonable business travel. The Company may modify Executive’s job title and duties as it deems necessary and appropriate in light of the Company’s needs and interests from time to time.

  • Policies and Procedures. The employment relationship between the Parties will be governed by the general employment policies and practices of the Company, except that when the terms of this Agreement differ from or are in conflict with the Company’s general employment policies or practices, this Agreement will control.

  • Compensation.

  • Salary. For services to be rendered hereunder, Executive will receive a base salary at the rate of $460,000 per year (the “Base Salary”) payable in installments in accordance

  • with the Company’s regular payroll schedule.

  • Bonus. Executive will be eligible for an annual discretionary bonus of up to 40% of Executive’s Base Salary (the “Annual Bonus”). Whether Executive receives an Annual Bonus for any given year, and the amount of any such Annual Bonus, will be determined by the Company’s Board of Directors (“Board”) in its sole discretion based upon the Company’s and Executive’s achievement of objectives and milestones to be determined on an annual basis by the Board. Executive must remain an active employee through the end of any given calendar year in order to earn an Annual Bonus for that year and any such bonus will be paid prior to March 15 of the year following the year in which such bonus was earned. Executive will not be eligible for, and will not earn, any Annual Bonus (including a prorated bonus) if Executive’s employment terminates for any reason before the end of the calendar year.

  • Equity. Pursuant to the Company’s Amended and Restated 2014 Equity Incentive Plan (as amended from time to time, the “Plan”), as further consideration for Executive’s continued employment under the terms of this Agreement, the Company granted Executive an option to purchase 185,000 shares of the Company’s common stock (“Common Stock”) on date of Option grant (the “Option”). The Option is subject to the terms and conditions of the Plan and Executive’s option agreement. The Option is subject to vesting over a four (4) year period according to the following schedule: 1/48th of the shares will vest on a monthly basis, so long as Executive remains in continuous service with the Company through the applicable vesting dates.

  • Standard Company Benefits. Executive shall be entitled to participate in all employee benefit programs for which Executive is eligible under the terms and conditions of the benefit plans that may be in effect from time to time and provided by the Company to its employees. The Company reserves the right to cancel or change the benefit plans or programs it offers to its employees at any time.

  • PAID TIME OFF. Executive will be entitled to accrue and use paid time off in accordance with the terms of the Company’s paid time off policy and practices, provided, however, that in no event will Executive’s paid time off accrual rate be lower than four (4) weeks per year.

  • EXPENSES. The Company will reimburse Executive for reasonable travel, entertainment or other expenses incurred by Executive in furtherance or in connection with the performance of Executive’s duties hereunder, in accordance with the Company’s expense reimbursement policy as in effect from time to time.

  • Termination of Employment; Severance.

  • At-Will Employment. Executive’s employment relationship is at-will. Either Executive or the Company may terminate the employment relationship at any time, with or without Cause or advance notice.

  • Termination Without Cause; Resignation for Good Reason.

  • Not in Connection with a Corporate Transaction. In the event Executive’s employment with the Company is terminated by the Company without Cause (other than by reason of death or disability), or Executive resigns for Good Reason, then provided such termination or resignation constitutes a “separation from service” (as defined under Treasury Regulation Section 1.409A-1(h), without regard to any alternative definition thereunder, a “Separation from Service”), the Separation from Service occurs more than 59 days prior to or 12 months after the closing of a Corporate Transaction, the Company shall pay Executive’s base salary

and accrued and unused vacation benefits earned through the date of termination, at the rate in effect at the time of termination, less standard deductions and withholdings. In addition, if Executive provides a signed release of claims in a form reasonably satisfactory to the Company (the “Release”) and allows such Release to become irrevocable and effective no later than 60 days following Executive’s Separation from Service, and provided that Executive remains in compliance with the terms of this Agreement and the Confidentiality Agreement (as defined below), the Company will provide Executive with the following severance benefits:

  • A cash lump-sum payment in an amount equal to twelve

(12) months of Executive’s annual base salary at the rate in effect on the effective date of Executive’s Separation from Service, ignoring any decrease in base salary that forms the basis for Good Reason, less standard deductions and withholdings, payable on the 60th day following Executive’s Separation from Service.

  • Provided Executive timely elects continued coverage under the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“COBRA”), the Company will pay the COBRA premiums to continue Executive’s coverage (including coverage for eligible dependents, if applicable), subject to withholding if deemed necessary to comply with applicable laws, through the period (the “COBRA Premium Period”) starting on the Executive’s Separation from Service and ending on the earliest to occur of: (A) twelve (12) months following Executive’s Separation from Service; (B) the date Executive becomes eligible for group health insurance coverage through a new employer; or (C) the date Executive ceases to be eligible for COBRA continuation coverage for any reason. In the event Executive becomes covered under another employer's group health plan or otherwise ceases to be eligible for COBRA during the COBRA Premium Period, Executive must immediately notify the Company of such event.
  • In Connection with a Corporate Transaction. In the event Executive’s employment with the Company is terminated by the Company without Cause (other than by reason of death or disability), or Executive resigns for Good Reason, and provided such termination or resignation constitutes a Separation from Service and such the Separation from Service occurs within 59 days prior to, on or within 12 months following the closing of a Corporate Transaction, the Company shall pay Executive’s base salary and accrued and unused vacation benefits earned through the date of termination, at the rate in effect at the time of termination, less standard deductions and withholdings. In addition, if Executive provides a signed Release and allows such Release to become irrevocable and effective no later than 60 days following Executive’s Separation from Service, and provided that Executive remains in compliance with the terms of this Agreement and the Confidentiality Agreement, the Company will provide Executive with the following severance benefits:
  • A cash lump-sum payment in an amount equal to twelve

(12) months of Executive’s annual base salary at the rate in effect on the effective date of Executive’s Separation from Service, ignoring any decrease in base salary that forms the basis for Good Reason, less standard deductions and withholdings, payable on the 60th day following Executive’s Separation from Service.

  • A cash lump-sum payment in an amount equal to the Executive’s full target bonus amount for services to be performed during the year in which the Corporate Transaction occurs, less standard deductions and withholdings, payable on the 60th day following Executive’s Separation from Service.
  • Provided Executive timely elects continued coverage under COBRA, the Company will pay the COBRA premiums to continue Executive’s coverage (including

coverage for eligible dependents, if applicable), subject to withholding if deemed necessary to comply with applicable laws, through the COBRA Premium Period. In the event Executive becomes covered under another employer’s group health plan or otherwise ceases to be eligible for COBRA during the COBRA Premium Period, Executive must immediately notify the Company of such event.

  • One hundred percent of any equity held by Executive will be deemed vested and exercisable (if applicable) as of Executive’s last day of employment, provided, however, that with respect to any performance based vesting equity awards held by Executive that have multiple vesting levels depending upon the level of performance, such equity awards will vest at the target level.
  • COBRA. Notwithstanding Sections 6.2(a)(ii) and 6.2(b)(iii), if the Company determines, in its sole discretion, that the Company cannot provide the COBRA premium benefits without potentially incurring financial costs or penalties under applicable law (including, without limitation, Section 2716 of the Public Health Service Act), the Company shall in lieu thereof pay Executive a taxable cash amount, which payment shall be made regardless of whether the Executive or the Executive’s qualifying family members elect COBRA continuation coverage (the “Health Care Benefit Payment”). The Health Care Benefit Payment shall be paid in monthly or bi- weekly installments on the same schedule that the COBRA premiums would otherwise have been paid to the insurer. The Health Care Benefit Payment shall be equal to the amount that the Company otherwise would have paid for COBRA insurance premiums (which amount shall be calculated based on the premium for the first month of coverage), and shall be paid until the expiration of the COBRA Premium Period, but determined without regard to whether or not the Executive continues to be eligible for COBRA coverage.
  • Resignation Without Good Reason; Termination for Cause; Death or Disability. If Executive resigns without Good Reason, or the Company terminates Executive’s service for Cause, or upon a termination due to Executive’s death or disability, then all payments of compensation by the Company to Executive hereunder will terminate immediately (except as to amounts already earned), and Executive will not be entitled to any severance benefits under Section 6.2(a) or Section 6.2(b).
  • Section 280G.
  • If any payment or benefit Executive would receive from the Company or otherwise (“Payment”) would (i) constitute a “parachute payment” within the meaning of Section 280G of the Code, and (ii) but for this sentence, be subject to the excise tax imposed by Section 4999 of the Code (the “Excise Tax”), then such 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 being subject to the Excise Tax or (y) the largest portion, up to and including the total, of the Payment, whichever amount, 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”). Notwithstanding the foregoing, 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 of the Code that would not otherwise be subject to taxes pursuant to Section 409A of the Code, 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 of the Code 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; (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 of the Code shall be reduced (or eliminated) before Payments that are not deferred compensation within the meaning of Section 409A of the Code.

  • In the event it is subsequently determined by the Internal Revenue Service that some portion of the Reduced Amount as determined pursuant to clause (x) in the preceding paragraph is subject to the Excise Tax, Executive agrees to promptly return to the Company a sufficient amount of the Payment so that no portion of the Reduced Amount is subject to the Excise Tax. For the avoidance of doubt, if the Reduced Amount is determined pursuant to clause (y) in the preceding paragraph, Executive will have no obligation to return any portion of the Payment pursuant to the preceding sentence.
  • Unless Executive and the Company agree on an alternative accounting firm, the accounting firm engaged by the Company for general tax compliance purposes as of the day prior to the effective date of the Corporate 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 Corporate Transaction, the Company shall appoint a nationally recognized accounting firm to make the determinations required hereunder. The Company shall bear all expenses with respect to the determinations by such accounting firm required to be made hereunder.
  • The Company shall use commercially reasonable efforts to cause the accounting 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 Payment is triggered (if requested at that time by Executive or the Company) or such other time as requested by Executive or the Company.
  • SECTION 409A.
  • It is intended that all of the severance benefits and other payments payable under this Agreement satisfy, to the greatest extent possible, the exemptions from the application of Code Section 409A provided under Treasury Regulations 1.409A-1(b)(4), 1.409A-1(b)(5) and 1.409A-1(b)(9), and this Agreement will be construed to the greatest extent possible as consistent with those provisions, and to the extent not so exempt, this Agreement (and any definitions hereunder) will be construed in a manner that complies with Code Section 409A.
  • A termination of employment will not be deemed to have occurred for purposes of any provision of this Agreement providing for the payment of any amounts or benefits upon or following a termination of employment unless such termination is also a Separation from Service and, for purposes of any such provision of this Agreement, references to a “termination,” “termination of service” or like terms will mean Separation from Service. If Executive is deemed on the date of termination to be a “specified employee” within the meaning of that term under Code Section 409A(a)(2)(B), then with regard to any payment or the provision of any benefit that is considered deferred compensation under Code Section 409A payable on account of a Separation from Service, such payment or benefit will be made or provided at the date which is the earlier of

(A) the expiration of the six-month period measured from the date of such Separation from Service of Executive, and (B) the date of Executive’s death, to the extent required under Code Section 409A.

5.

Upon the expiration of the foregoing delay period, all payments and benefits delayed pursuant to this Section 8.2 (whether they would have otherwise been payable in a single sum or in installments in the absence of such delay) will be paid or reimbursed to Executive in a lump sum, and any remaining payments and benefits due under this Agreement will be paid or provided in accordance with the normal payment dates specified for them herein.

  • To the extent that reimbursements or other in-kind benefits under this Agreement constitute “nonqualified deferred compensation” for purposes of Code Section 409A, (A) all expenses or other reimbursements hereunder will be made on or prior to the last day of the taxable year following the taxable year in which such expenses were incurred by Executive, (B) any right to reimbursement or in-kind benefits will not be subject to liquidation or exchange for another benefit, and (C) no such reimbursement, expenses eligible for reimbursement, or in-kind benefits provided in any taxable year will in any way affect the expenses eligible for reimbursement, or in-kind benefits to be provided, in any other taxable year.

  • For purposes of Code Section 409A, Executive’s right to receive any installment payments pursuant to this Agreement will be treated as a right to receive a series of separate and distinct payments. Whenever a payment under this Agreement specifies a payment period with reference to a number of days, the actual date of payment within the specified period will be within the sole discretion of the Company. Notwithstanding any other provision of this Agreement to the contrary, in no event will any payment under this Agreement that constitutes “nonqualified deferred compensation” for purposes of Code Section 409A be subject to offset by any other amount unless otherwise permitted by Code Section 409A.

  • Definitions.

  • “Cause” with respect to Executive means Executive has: (a) been convicted of or pled guilty or nolo contendere to a felony or any crime involving moral turpitude or dishonesty;

(b) participated in a fraud or act of dishonesty against the Company; (c) materially breached any agreement between such Executive and the Company or any written policy of the Company, and not cured such breach within five days of the Company’s written notice of such breach; (d) engaged in conduct that demonstrates gross unfitness to serve; or (e) engaged in willful misconduct or refused to comply with any lawful directive of the Company, and not cured such noncompliance within five days of the Company’s written notice of such noncompliance.

  • “Code” means the Internal Revenue Code of 1986, as amended.
  • “Good Reason” will exist for Executive’s resignation from employment with the Company if any of the following actions are taken by the Company without Executive’s prior written consent:
  • a material reduction in Executive’s base salary, unless pursuant to a salary reduction program applicable generally to the Company’s similarly situated employees;
  • a material reduction in Executive’s duties (including responsibilities and/or authorities);
  • a material reduction in the authority, duties, or responsibilities of the supervisor to whom Executive is required to report, including a requirement that Executive report to an employee of the Company instead of the Chief Executive Officer;
  • relocation of Executive’s principal place of employment to a place that increases Executive’s one-way commute by more than 50 miles as compared to Executive’s
  • then-current principal place of employment immediately prior to such relocation; or
  • any other action or inaction that constitutes a material breach by the Company of this Agreement or any agreement under which Executive provides services.

Provided, however that, such termination by the Executive shall only be deemed for Good Reason pursuant to the foregoing definition if (i) the Company is given written notice from the Executive within 30 days following the first occurrence of the condition that Executive considers to constitute Good Reason describing the condition and the Company fails to satisfactorily remedy such condition within 30 days following such written notice, and (ii) the Executive terminates employment within 90 days following the end of the period within which the Company was entitled to remedy the condition constituting Good Reason but failed to do so.

  • “Corporate Transaction” means the consummation, in a single transaction or in a series of related transactions, of any one or more of the following events:
  • a sale, lease or other disposition of all or substantially all, as determined by the Board in its sole discretion, of the consolidated assets of the Company and its subsidiaries;
  • a merger, consolidation, or similar transaction of the Company following which such entity is not the surviving entity;
  • a merger, consolidation or similar transaction of the Company following which such entity is the surviving entity but the shares outstanding immediately preceding the merger, consolidation or similar transaction are converted or exchanged by virtue of the merger consolidation or similar transaction into other property, whether in the form of securities, cash or otherwise.

Notwithstanding the foregoing, the term Corporate Transaction will not include (i) a sale of assets, merger or other transaction effected exclusively for the purpose of changing the domicile of the Company, or (ii) the acquisition of securities of the Company by an investor or any affiliate thereof that acquires the Company’s securities in a transaction or series of related transactions the primary purpose of which is to obtain financing for the Company through the issuance of equity securities. In addition, to the extent required for compliance with Code Section 409A, in no event will an event be deemed a Corporate Transaction if such transaction is not also a “change in the ownership or effective control of” the Company or “a change in the ownership of a substantial portion of the assets of” the Company as determined under Treasury Regulation Section 1.409A-3(i)(5) (without regard to any alternative definition thereunder).

  • Proprietary Information Obligations.

  • Confidential Information Agreement. As a condition of Executive’s continued employment, Executive will continue to abide by the Employee Proprietary Information and Inventions Agreement1 (the “Confidentiality Agreement”) and Arbitration Agreement previously executed by Executive.

  • Third-Party Agreements and Information. Executive represents and

.

warrants that Executive’s employment by the Company does not conflict with any prior employment or consulting agreement or other agreement with any third party, and that Executive will perform

7.

Executive’s duties to the Company without violating any such agreement. Executive represents and warrants that Executive does not possess confidential information arising out of prior employment, consulting, or other third party relationships, that would be used in connection with Executive’s employment with the Company, except as expressly authorized by that third party. During Executive’s employment with the Company, Executive will use in the performance of Executive’s duties only information which is generally known and used by persons with training and experience comparable to Executive’s own, common knowledge in the industry, otherwise legally in the public domain, or obtained or developed by the Company or by Executive in the course of Executive’s work for the Company.

  • Outside Activities During Employment.

  • Non-Company Business. Except with the prior written consent of the Chief Executive Officer, Executive will not during the term of Executive’s employment with the Company undertake or engage in any employment, occupation or business enterprise, other than ones in which Executive is a passive investor or as permitted under Section 11.2. Executive shall be entitled to serve on the board of directors of such other companies as may be approved in advance by the Chief Executive Officer, in each case, so long as Executive remain in compliance with this Section 11 and such service does not interfere with Executive’s duties under this Agreement. Executive may engage in civic and not-for-profit activities so long as such activities do not materially interfere with the performance of Executive’s duties hereunder.

  • No Adverse Interests. Except with the prior written consent of the Chief Executive Officer, Executive will not during the term of Executive’s employment with the Company acquire, assume or participate in, directly or indirectly, any position, investment or interest known to be adverse or antagonistic to the Company, its business or prospects, financial or otherwise, provided that this does not prohibit Executive’s continued involvement in any existing investments or ownership, for investment purposes only, of not more than 3% of the outstanding stock of any company listed on a national securities exchange, or actively traded in a national over-the-counter market.

  • NON-SOLICITATION. Executive agrees that, to the extent permitted by applicable law, during the period of employment with the Company and for 12 months after the date Executive’s employment is terminated for any reason, Executive will not, either directly or through others, solicit or encourage or attempt to solicit or encourage any employee, independent contractor, or consultant of the Company to terminate his or her relationship with the Company.

  • General Provisions.

  • Notices. Any notices provided must be in writing and will be deemed effective upon the earlier of personal delivery (including personal delivery by fax) or the next day after sending by overnight carrier, to the Company at its primary office location and to Executive at the address as listed on the Company payroll.

  • Severability. 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 to the extent possible in keeping with the intent of the parties.

  • Waiver. Any waiver of any breach of any provisions of this Agreement must be in writing to be effective, and it will not thereby be deemed to have waived any preceding or

  • succeeding breach of the same or any other provision of this Agreement.
  • Complete Agreement. This Agreement, together with the Confidentiality Agreement and the Arbitration Agreement, constitute the entire agreement between Executive and the Company with regard to this subject matter and is the complete, final, and exclusive embodiment of the Parties’ agreement with regard to this subject matter. This Agreement is entered into without reliance on any promise or representation, written or oral, other than those expressly contained herein, and it supersedes any other such promises, warranties or representations, including the Original Agreement. Executive agrees and acknowledges that there are no circumstances as of the date of this Agreement that constitute, and nothing contemplated in this Agreement shall be deemed for any purpose to be or to create, an involuntary termination without Cause or a Good Reason resignation right, including for purposes of the Original Agreement, or any other severance or change in control plan, agreement or policy maintained by the Company. Executive further hereby expressly waives any claim or right Executive may have as of the date of this Agreement (if any) to assert that this Agreement, or any other condition or occurrence, forms the basis for a without Cause termination or Good Reason resignation for any purpose, including for purposes of the Original Agreement, or any other severance or change in control plan, agreement or policy maintained by the Company. This Agreement cannot be modified or amended except in a writing signed by a duly authorized officer of the Company.
  • Counterparts. 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.
  • Headings. The headings of the paragraphs hereof are inserted for convenience only and will not be deemed to constitute a part hereof nor to affect the meaning thereof.
  • Successors and Assigns. This Agreement is intended to bind and inure to the benefit of and be enforceable by Executive and the Company, and their respective successors, assigns, heirs, executors and administrators, except that Executive may not assign any of Executive’s duties hereunder and Executive may not assign any of Executive’s rights hereunder without the written consent of the Company, which will not be withheld unreasonably.
  • Choice of Law. All questions concerning the construction, validity and interpretation of this Agreement will be governed by the laws of the State of California.

In Witness Whereof, the Parties have executed this Agreement on the day and year first written above.

Kura Oncology, Inc.
By: /s/ Troy Wilson, Ph.D., J.D.
Name: Troy Wilson, Ph.D., J.D.<br><br>Title: President and CEO
Executive
---
/s/ Francis Burrows
Francis Burrows

9.

EX-10.36

Exhibit 10.36

DIRECTORS SCIENCE PARK

LEASE

This Lease (the "Lease"), dated as of the Effective Date set forth in Section 1 of the Summary of Basic Lease Information below (the "Summary"), is made by and between HCP LIFE SCIENCE REIT, INC., a Maryland corporation ("Landlord"), and KURA ONCOLOGY, INC., a Delaware corporation ("Tenant"). The Tenant originally named in the foregoing sentence may be referred to in this Lease as the "Original Tenant."

SUMMARY OF BASIC LEASE INFORMATION

TERMS OF LEASE DESCRIPTION
<ul><li><font>Effective Date:</font></li></ul> January 13, 2025
<ul><li><font>Building; Premises; Project<br>(</font><font>Article 1</font><font>).</font></li></ul>
<ul><li><font>Building:</font></li></ul> That certain building containing approximately 165,543 rentable square feet of space ("RSF") located at 4930 Directors Place, San Diego, CA 92121.
<ul><li><font>Premises:</font></li></ul> Stipulated by the parties to be approximately 32,512 rentable square feet of space comprising the entire 5th floor of the Building, as further set forth in Exhibit A to the Lease.
<ul><li><font>Project:</font></li></ul> The office / laboratory development, commonly referred to as Directors Science Park, and consisting of the Building, the Common Areas, other building(s) and land upon which such development is located, and any other building(s) and land from time to time reasonably designated by Landlord, provided, any such designation shall be deemed reasonable if such building(s) and land are located at Director's Place.
<ul><li><font>Lease Term<br>(</font><font>Article 2</font><font>).</font></li></ul>
<ul><li><font>Lease Term:</font></li></ul> Approximately ninety-two (92) months from and after the Lease Commencement Date.
<ul><li><font>Lease Commencement<br>Date:</font></li></ul> The earlier to occur of (i) the date upon which Tenant first commences to conduct business in the Premises, and (ii) October 1, 2025 (the "Outside LCD"). The Outside LCD shall be extended by the number of days of actual delay in the Substantial Completion of the Tenant Improvements to the extent such delay is a result of Landlord Caused Delays (as such terms are defined below), so long as clause (i) above does not apply.
Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
---
<ul><li><font>Lease Expiration Date:</font></li></ul> The last day of the ninety-second (92nd) full calendar month following the Lease Commencement Date.
--- ---
<ul><li><font>Option Term(s):</font></li></ul> Tenant has one (1) option (an "Extension Option") to extend the Lease Term for a period of five (5)-years (an "Option Term"), as more particularly set forth in Section 2.2 of this Lease.
<ul><li><font>Base Rent (</font><font>Article 3</font><font>):</font></li></ul>
Period (Lease Months) Annual<br>Base Rent Monthly<br>Installment<br>of Base Rent Approximate<br>Monthly Base<br>Rent per Rentable<br>Square Foot*
--- --- --- ---
1 – 12** $2,204,316.00 $183,693.00 $5.65
13 – 24** $2,270,448.00 $189,204.00 $5.82
25 – 36 $2,338,560.00 $194,880.00 $5.99
37 – 48 $2,408,712.00 $200,726.00 $6.17
49 – 60 $2,480,976.00 $206,748.00 $6.36
61 – 72 $2,555,400.00 $212,950.00 $6.55
73 – 84 $2,632,068.00 $219,339.00 $6.75
85 – 92 $2,711,028.00 $225,919.00 $6.95
* The amounts identified in the column entitled "Approximate Monthly Base Rent per Rentable Square Foot" are rounded amounts and are provided for informational purposes only. The amounts identified in the columns entitled "Annual Base Rent" and "Monthly Installment of Base Rent" shall control.
--- ---
** Subject to the terms set forth in Section 3.2 of this Lease, the Base Rent attributable to the second (2nd) through the fourteenth (14th) month period commencing on the first (1st) day of the second (2nd) full calendar month of the Lease Term and ending on the last day of the fourteenth (14th) full calendar month of the Lease Term shall be abated.
<ul><li><font>Tenant</font><font> </font><font>Improvement Allowance</font><font> </font><font>(</font><font>Exhibit B</font><font>):</font></li></ul> $189.50 per rentable square foot of the Premises for a total of $6,161,024.00, subject to the terms of the Tenant Work Letter attached hereto as Exhibit B.
<ul><li><font>Tenant's Share<br>(</font><font>Article 4</font><font>):</font></li></ul> Nineteen and 64/100 percent (19.64%).
-2- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
--- ---
<ul><li><font>Permitted Use<br>(</font><font>Article 5</font><font>):</font></li></ul> The Premises shall be used only for general office, research and development, and/or laboratory uses, including, but not limited to, administrative offices and other lawful uses reasonably related to or incidental to such specified uses, all (i) consistent with first class life sciences projects in San Diego, California ("First Class Life Sciences Projects"), and (ii) in compliance with, and subject to, Applicable Laws (as that term is defined in Article 24) and the terms of this Lease.
--- ---
<ul><li><font>Security Deposit; Letter of Credit<br>(</font><font>Article 21</font><font>): </font></li></ul> Security Deposit: $285,821.00.<br><br>Letter of Credit: None
<ul><li><font>Parking<br>(</font><font>Article 28</font><font>):</font></li></ul> During the Lease Term, Tenant shall be entitled to eighty-four (84) unreserved parking passes and six (6) reserved parking passes shall be for the use of a reserved parking space, all free of charge and, in all cases subject to the terms of Article 28 of this Lease.
<ul><li><font>Address of Tenant<br>(</font><font>Section 29.18</font><font>):</font></li></ul> Kura Oncology, Inc.<br><br>12730 High Bluff Drive<br><br>Suite 400<br><br>San Diego, CA 92130<br>Attention: Tom Doyle<br>Email*: <br>(Prior to Lease Commencement Date)
and<br><br>Kura Oncology, Inc.<br><br>The Premises<br>Attention: Tom Doyle<br>(After Lease Commencement Date)<br><br><br><br>With a Copy to:<br><br><br><br>Cooley LLP<br><br>11951 Freedom Drive 14th Floor<br><br>Reston, VA 20190<br><br>Attn: John G. Lavoie, Esq.
<ul><li><font>Address of Landlord<br>(</font><font>Section 29.18</font><font>):</font></li></ul> See Section 29.18 of the Lease.
-3- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
--- ---
<ul><li><font>Broker(s)<br>(</font><font>Section 29.24</font><font>):</font></li></ul> Representing Landlord:<br><br>CBRE, Inc.<br><br>Representing Tenant:<br><br>Jones Lang LaSalle
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<ul><li><font>Guarantor (</font><font>Section 29.34</font><font>):</font></li></ul> None.
<ul><li><font>Amount Due Upon Lease Execution:</font></li></ul> $183,693.00, as first month's Base Rent<br><br>$50,394.00, as first month's estimated Direct Expenses<br><br>$234,087.00 Total
-4- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
--- ---
  • PREMISES, BUILDING, PROJECT, AND COMMON AREAS
  • Premises, Building, Project and Common Areas.
  • The Premises; Tender of Possession. Landlord hereby leases to Tenant and Tenant hereby leases from Landlord the premises set forth in Section 2.2 of the Summary (the "Premises"). The outline of the Premises is set forth in Exhibit A attached hereto. The outline of the "Building" and the "Project," as those terms are defined in Section 1.1.2 below, are further depicted on the site plan attached hereto as Exhibit A‑1 (the "Site Plan"). The parties hereto agree that the lease of the Premises is upon and subject to the terms, covenants and conditions herein set forth, and Tenant covenants as a material part of the consideration for this Lease to keep and perform each and all of such terms, covenants and conditions by it to be kept and performed and that this Lease is made upon the condition of such performance. The parties hereto hereby acknowledge that the purpose of Exhibit A is to show the approximate location of the Premises only, and such Exhibit is not meant to constitute an agreement, representation or warranty as to the construction of the Premises, the precise area thereof or the specific location of the "Common Areas," as that term is defined in Section 1.1.3, below, or the elements thereof or of the accessways to the Premises or the "Project," as that term is defined in Section 1.1.2, below. Except as specifically set forth in this Lease and in the Tenant Work Letter attached hereto as Exhibit B (the "Tenant Work Letter"), Landlord shall tender possession of the Premises to Tenant in its existing, "as is" condition, and in good, vacant and broom clean condition and shall cause the Building Systems (as that term is defined in Section 7.3 below), and Emergency Generator (as defined below) (and the Emergency Generator’s transfer switches) serving the Premises to be in good operating condition and repair, on or before the Lease Commencement Date and Landlord shall not be obligated to provide or pay for any improvement work or services related to the improvement of the Premises except as expressly set forth herein. Notwithstanding anything in this Lease to the contrary, in connection with the foregoing commitment to deliver the Premises in good operating condition, Landlord shall, at Landlord's sole cost and expense (which shall not be deemed an "Operating Expense," as that term is defined in Section 4.2.3), repair or replace any failed or inoperable portion of the Base Building, shell and/or core, the Building Systems (as defined below) and/or the Emergency Generator (and the Emergency Generator’s transfer switches) serving the Premises for which it receives written notice and reasonable evidence from Tenant during the first twelve (12) months of the initial Lease Term that such component of the Base Building, shell and/or core, Building Systems and/or Emergency Generator (including its transfer switches) has failed or is inoperable ("Warranty Period"), provided that the need to repair or replace was not caused by the misuse, misconduct, damage, destruction, and/or negligence of Tenant, its subtenants and/or assignees, if any, or any company which is acquired, sold or merged with Tenant (collectively, "Tenant Damage"), or by any modifications, Alterations or improvements constructed by or on behalf of Tenant. Landlord shall coordinate such work with Tenant and shall utilize commercially reasonable efforts to perform the same in a manner designed to minimize interference with Tenant's use of the Premises. To the extent repairs which Landlord is required to make pursuant to this Section 1.1.1 are necessitated in part by Tenant Damage, then Tenant shall reimburse Landlord for an equitable proportion of the cost of such repair. Landlord shall be deemed to have tendered possession of the Premises to Tenant upon the date (the "Possession Date") that Landlord provides Tenant with a key or access card to the Premises, and no action by Tenant shall be required therefor. The Possession Date should occur within fifteen (15) days following the Effective Date. Notwithstanding anything in this Section 1.1.1 above to the contrary, if Landlord fails to cause the Possession Date to occur on or before the date that is thirty (30) days after the Effective Date (the "Possession Deadline"), which Possession Deadline shall be extended day for day for each day Landlord fails to cause the Possession Date to occur as a result of any Tenant Delays (as defined below), and/or any events of Force Majeure (as defined below), then Landlord shall abate one (1) day of Base Rent for every one (1) day of delay that Landlord fails to cause the Possession Date to occur beyond the Possession Deadline (as so extended). Further, if Landlord fails to cause the Possession Date to occur on or before the date that is one hundred twenty (120) days after the Effective Date (the "Outside Possession Date"), which Outside Possession Date shall be extended day for day for each day Landlord fails to cause the Possession Date to occur as a result of any Tenant Delays (as defined below), and/or any events of Force Majeure (as defined below), then Tenant, at its option, may terminate this Lease by written notice to Landlord given at any time after the Outside Possession Date but before Landlord causes the Possession Date to occur. In the event of such termination by Tenant, all sums paid by Tenant to Landlord under this Lease shall be fully refunded to Tenant and neither party shall have any further obligations hereunder. The abatement right and termination right afforded to Tenant under this Section 1.1.1 shall be Tenant's sole and exclusive remedies for Landlord's failure to cause the Possession Date to occur by the Possession Deadline and/or the Outside Possession Date respectively (as so extended). Neither Landlord nor any agent of Landlord has made any representation or warranty regarding the condition of the Premises, the Building or the Project or with respect to the suitability of any of the foregoing for the
Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
  • conduct of Tenant's business, except as specifically set forth in this Lease and the Tenant Work Letter. Any process utilities shall be provided without warranty, in their currently existing, "as-is" condition. As used herein, the term "Tenant Delays" shall mean any delays in delivering the Premises as a result of any acts or omissions of Tenant or any Tenant Parties.
  • The Building and The Project. The Premises constitutes a portion of the building set forth in Section 2.1 of the Summary (the "Building"). The Building is part of an office/laboratory project currently known as "Directors Science Park." The term "Project," as used in this Lease, shall mean (i) the Building and the Common Areas, (ii) the land (which is improved with landscaping, parking facilities and other improvements) upon which the Building and the Common Areas are located, (iii) at Landlord's option, the other office/laboratory buildings located at Directors Science Park, and the land upon which such adjacent office/laboratory buildings are located, (iv) certain amenity space (the following collectively, the "Amenity Space") serving the tenants of the Project, which will initially include a fitness center with showers and locker rooms and a café (the "Café") (provided that Landlord reserves the right to modify the amenities which constitute the Amenity Space), and (v) at Landlord's discretion, any additional real property, areas, land, buildings or other improvements added thereto as part of the Project, including areas that may currently be outside of the Project. Tenant acknowledges that Landlord or an affiliate of Landlord (or any successors thereto) is or may be intending to develop and construct additional buildings, parking structures, and other improvements as a part of the Project, which may be operated as part of the Project whether owned by Landlord, an affiliate of Landlord, or a third party. Landlord shall use commercially reasonable efforts to ensure that (a) the fitness center is operable and ready for use upon the Lease Commencement Date and that (b) the Café is operable and ready for use no later than when the Building occupancy reaches at least fifty percent (50%). Once opened, Landlord hereby agrees to utilize commercially reasonable efforts to operate and maintain such Amenity Space throughout the Lease Term and/or any Option Term; provided, however, Tenant nevertheless acknowledges that if despite such commercially reasonable efforts Landlord is unable for any reason to maintain continuous operation of the Amenity Space during the Lease Term and/or any Option Term, in no event shall such failure be deemed a default hereunder, nor shall such failure impact the validity of this Lease and Landlord shall not be subject to any liability for such failure, provided that in such event Landlord shall utilize commercially reasonable efforts to provide replacement amenities (e.g., an on-site café in a different location or the routine scheduling of food trucks to the Project).
  • Common Areas. Tenant shall have the non-exclusive right to use in common with other tenants in the Project, and subject to the rules and regulations referred to in Article 5 of this Lease, those portions of the Project which are provided, from time to time, for use in common by Landlord or an affiliate of Landlord or any other owner of the Project (or any portion thereof), Tenant and any other tenants of the Project, including, but not limited to the parking areas of the Project (such areas, together with such other portions of the Project designated by Landlord, in its discretion, are collectively referred to herein as the "Common Areas"). The manner in which the Common Areas are maintained and operated shall be at the sole discretion of Landlord and the use thereof shall be subject to such rules, regulations and restrictions as Landlord may make from time to time, provided that such rules do not unreasonably restrict Tenant's access to or use of the Premises for the Permitted Use nor materially and adversely diminish Tenant's rights under this Lease. In accordance with Section 29.29 below, Landlord reserves the right to close temporarily, make alterations or additions to, or change the location of elements of the Project and the Common Areas. Landlord shall use commercially reasonable efforts to minimize interference with Tenant's access to and operations within the Premises in connection with such work, and the size and layout of the Premises shall not be materially altered.
  • Rentable Square Feet of Premises. The rentable square footage of the Premises is hereby deemed to be as set forth in Section 2.2 of the Summary, and shall not be subject to measurement or adjustment during the Lease Term.
  • Right of First Refusal. Landlord hereby grants to the Original Tenant (and any Permitted Assignee (as defined below)) during the initial Lease Term only an ongoing right of first refusal with respect to any available space in the Building containing less than 30,000 rentable square feet (the "Refusal Space"). Notwithstanding the foregoing, such right of first refusal of Tenant shall commence only following the expiration or earlier termination of any existing leases (including renewals) of the Refusal Space as of the Lease Commencement Date, and such right of first refusal shall be subordinate to any rights with respect to such Refusal Space which are set forth in existing leases of space in the Project, including any renewal, extension or expansion rights (including, but not limited to, must-take, right of first offer, right of first negotiation, right of first refusal, expansion option and other similar rights) set forth
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  • in such leases (all such tenants under such leases are collectively referred to herein as the "Superior Right Holders"). Tenant's right of first refusal shall be on the terms and conditions set forth in this Section 1.4.
  • Procedure for Offer. Landlord shall notify Tenant (the "Refusal Notice") when and if Landlord receives a "bona-fide third-party offer" for all or a portion of the Refusal Space during the initial Lease Term, provided that the Superior Right Holders have waived their rights to such Refusal Space. Pursuant to such Refusal Notice, Landlord shall offer to lease to Tenant such Refusal Space on the same terms as set forth in the bona-fide third-party offer. The Refusal Notice shall describe the Refusal Space, the lease term, base rent and other fundamental material economic terms and conditions, including the method of measurement of rentable square feet, upon which Landlord proposes to lease such Refusal Space pursuant to the bona-fide third-party offer. For purposes of this Section 1.3, a "bona-fide third-party offer" shall mean a counter-offer received by Landlord to lease the subject Refusal Space from a qualified third party on terms Landlord is willing to accept. For purposes of example only, the following would each constitute a bona-fide third-party offer:
  • Landlord receives a request for proposal from a qualified third party. Landlord responds to the request for proposal with a lease proposal and subsequently receives a written bona-fide counter proposal from the qualified third party on terms Landlord is willing to accept; or
  • Landlord receives a written offer to lease from a qualified third party. Landlord responds to the offer with a written counter offer and subsequently receives a bona-fide counter to Landlord's counter offer from the qualified third party on terms Landlord is willing to accept.
  • Procedure for Acceptance. If Tenant wishes to exercise Tenant's right of first refusal with respect to the Refusal Space described in the Refusal Notice, then within seven (7) business days of delivery of the Refusal Notice to Tenant, Tenant shall deliver written notice to Landlord (the "Refusal Exercise Notice") of Tenant's irrevocable exercise of its right of first refusal with respect to all of the Refusal Space described in the Refusal Notice at the rent, and upon the other fundamental material economic terms and conditions contained in such Refusal Notice. If Tenant does not deliver the Refusal Exercise Notice to Landlord within such seven (7) business day period, then, Landlord shall be free to negotiate and enter into a lease or lease amendment for the Refusal Space subject to the bona-fide third-party offer with anyone and on any terms Landlord desires and Tenant shall no longer have a right of first refusal for such Refusal Space; provided, however, that if Landlord, within one hundred eighty (180) days after Tenant's failure to exercise Tenant's right of first refusal, intends to enter into a lease upon Economic Terms which are, in the aggregate, materially more favorable to a prospective tenant than those Economic Terms proposed by Landlord in the Refusal Notice to Tenant, then Landlord shall first deliver written notice to Tenant ("Second Chance Notice") providing Tenant with the opportunity to lease the Refusal Space on such more favorable Economic Terms (such more favorable terms in the Second Chance Notice are referred to herein as the "Second Chance Economic Terms"). The term "Economic Terms" means: (a) the rental rate; (b) the amount of any improvement allowance or the value of any work to be performed by Landlord in connection with the lease of such space (which amount is a deduction from the cost to Tenant or such other party); (c) the amount of free rent or abated rent; and (d) any other monetary concessions. For purposes hereof, Second Chance Economic Terms shall be materially more favorable to a third party if such Second Chance Economic Terms reflect a net effective rental rate (taking into account all Economic Terms) less than ninety percent (90%) of the net effective rental rate for such Refusal Space as the Economic Terms initially proposed by Landlord in the Refusal Notice. Tenant's failure to elect to lease the Refusal Space upon such Second Chance Economic Terms by written notice to Landlord within five (5) business days after Tenant's receipt of such Second Chance Notice from Landlord shall be deemed to constitute Tenant's election not to lease such space upon such Second Chance Economic Terms, in which case Landlord shall be entitled to lease such space to any third (3rd) party on any terms Landlord desires at the Second Chance Economic Terms.
  • Amendment to Lease. If Tenant timely exercises Tenant's right of first refusal to lease the Refusal Space as set forth herein, Landlord and Tenant shall use commercially reasonable efforts to thereafter execute an amendment to this Lease (the "Refusal Space Amendment") within thirty (30) days for such Refusal Space upon the terms set forth in the Refusal Notice, but otherwise upon the terms and conditions set forth in this Lease and this Section 1.3; provided, however, an otherwise valid exercise of the such right of first refusal shall be fully effective whether or not a lease amendment is executed.
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  • Termination of Refusal Right. The rights contained in this Section 1.3 shall be personal to the Original Tenant and any Permitted Assignee, and may only be exercised during the initial Lease Term by the Original Tenant and any Permitted Assignee (and not any other assignee, sublessee or other transferee of Original Tenant's interest in this Lease) if the Original Tenant or Permitted Assignee occupies no less than one hundred percent (100%) of the then-existing Premises. The right of first refusal granted herein shall terminate as to a particular Refusal Space upon Tenant's failure to timely exercise its right of first offer with respect to such particular Refusal Space, except as otherwise expressly set forth in Section 1.3.2 above. The right to lease the Refusal Space as provided in this Section 1.3 may not be exercised if, as of the date of the attempted exercise of the right of first refusal by Tenant, or as of the scheduled date of delivery of the Refusal Space to Tenant, Tenant is in default (beyond applicable notice and cure periods) under this Lease. The right of first refusal granted herein shall terminate as to all Refusal Space and thereafter shall be of no further force or effect upon the expiration of the initial Lease Term.
  • LEASE TERM; OPTION TERM; EARLY TERMINATION RIGHT
  • Lease Term. The terms and provisions of this Lease shall be effective as of the Effective Date. The term of this Lease (the "Lease Term") shall be as set forth in Section 3.1 of the Summary, shall commence on the date set forth in Section 3.2 of the Summary (the "Lease Commencement Date"), and shall terminate on the date set forth in Section 3.3 of the Summary (the "Lease Expiration Date") unless this Lease is sooner terminated or extended as hereinafter provided. For purposes of this Lease, the term "Lease Year" shall mean each consecutive twelve (12) month period during the Lease Term, provided that if the Lease Commencement Date occurs on other than the first day of a month, the first "Lease Year" shall commence on the Lease Commencement Date and end on the last day of the month in which the first anniversary of the Lease Commencement Date occurs (or if the Lease Commencement Date is the first day of a calendar month, then the first Lease Year shall commence on the Lease Commencement Date and end on the day immediately preceding the first anniversary of the Lease Commencement Date), and the second and each succeeding Lease Year shall commence on the first day of the next calendar month; and further provided that the last Lease Year shall end on the Lease Expiration Date. The term "Lease Month" shall mean each succeeding calendar month during the Lease Term; provided, however, that the first Lease Month shall commence on the Lease Commencement Date and shall end on the last day of the first (1st) full calendar month of the Lease Term (or if the Lease Commencement Date is the first day of a calendar month, then the first Lease Month shall be that calendar month) and that the last Lease Month shall expire on the Lease Expiration Date. At any time during the Lease Term, once the Lease Commencement Date has been determined in accordance with Section 3.2 of the Summary, Landlord may deliver to Tenant a written notice memorializing such Lease Commencement Date.
  • Extension Option(s).
  • Option Right. Upon the proper exercise of the Extension Option in accordance with the provisions of this Section 2.2 by Original Tenant or any assignee of Original Tenant's entire interest in the Lease that has been approved in accordance with the terms of Article 14, below (a "Permitted Assignee"), the Lease Term shall be extended for the Option Term. Such Extension Option shall be exercisable only by written notice delivered by Tenant to Landlord not more than twelve (12) months nor less than nine (9) months prior to the expiration of the initial Lease Term, stating that Tenant is thereby irrevocably exercising its option to lease the Premises during the Option Term. Upon the proper exercise of the Extension Option, and provided that, at Landlord's option, as of the date of delivery of such notice, Tenant is not in default under this Lease (beyond the applicable notice and cure periods) and has not previously been in default under this Lease (beyond the applicable notice and cure periods) more than twice, and as of the end of the initial Lease Term, Tenant is not in default under this Lease (beyond the applicable notice and cure periods), the Lease Term shall be extended for a period of five (5) years. The rights contained in this Section 2.2 shall be personal to Original Tenant and any Permitted Assignee (and not any other assignee, sublessee or "Transferee," as that term is defined in Section 14.1, below, of Tenant's interest in this Lease). In the event that Tenant fails to timely and appropriately exercise its option to extend the Lease Term in accordance with the terms of this Section 2.2, then such option shall automatically terminate and shall be of no further force or effect. Further, notwithstanding anything to the contrary herein, Tenant's Extension Option shall terminate upon the earliest to occur of (i) Tenant's assignment of this Lease, other than to a Permitted Assignee, (ii) Tenant's sublease of fifty percent (50%) or more of the entire then-existing Premises, other than to a Permitted Transferee for substantially the remaining Lease Term, (iii) intentionally omitted, and (iv) the occurrence of the second (2nd)Event of Default.
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  • Option Rent. The Base Rent payable by Tenant during the Option Term (the "Option Rent") for all of the Premises shall be equal to the "Fair Rental Value" (as defined below). Landlord shall have the right to require Tenant to provide additional security in the form of a cash security deposit in order to increase the Security Deposit under this Lease (provided, however, that such increased amount shall not cause the total Security Deposit under this Lease to exceed the last month's Rent for the Option Term), based upon Landlord's review of Tenant's financial statements (and in connection therewith, Tenant shall provide the financial statements referenced in Section 17.2 of this Lease within ten (10) business days of Landlord's request) if (i) there has been a material adverse change in Tenant's financial condition as compared to Tenant's financial condition as of the Effective Date, (ii) Tenant's receipt of an improvement allowance or other economic concessions during the Option Term, (iii) Tenant's construction, or contemplated construction, of Tenant Improvements or "Alterations" (as that term is defined in Section 8.1 below) that have above-standard demolition and removal costs, and which Tenant is obligated to remove upon expiration of the Lease Term, (iv) Tenant is involved in a lawsuit, or any other situation exists, that Landlord reasonably believes could materially impair Tenant's ability to perform its obligations under this Lease, or (v) reasonably required based on Landlord's review of financial security then generally being imposed in Comparable Transactions (as defined below) from tenants of comparable financial condition and credit history, as compared to the then existing financial condition and credit history of Tenant (and giving reasonable consideration to Tenant's prior performance history during the Lease Term). The "Fair Rental Value," as used in this Lease, shall be equal to the annual rent per rentable square foot (including additional rent and considering any "base year" or "expense stop" applicable thereto), including all escalations, at which tenants (pursuant to leases consummated within the fifteen (15) month period preceding the first day of the Option Term), are leasing non-sublease, non-encumbered, non-equity space which is not significantly greater or smaller in size than the subject space, with a comparable level of improvements (excluding any property that Tenant would be allowed to remove from the Premises at the termination of the Lease), for a comparable lease term, in an arm's length transaction, which comparable space is located in the "Comparable Buildings," as that term is defined in this Section 2.2.2, below (transactions satisfying the foregoing criteria shall be known as the "Comparable Transactions"), taking into consideration the following concessions (the "Concessions"): (a) rental abatement concessions, if any, being granted such tenants in connection with such comparable space; (b) tenant improvements or allowances provided or to be provided for such comparable space, and taking into account the value, if any, of the existing improvements in the subject space (other than improvements installed by Tenant at Tenant's sole cost and expense), such value to be based upon the age, condition, design, quality of finishes and layout of the improvements and the extent to which the same can be utilized by a general office/lab user other than Tenant; and (c) other reasonable monetary concessions being granted such tenants in connection with such comparable space; provided, however, that in calculating the Fair Rental Value, no consideration shall be given to the fact that Landlord is or is not required to pay a real estate brokerage commission in connection with Tenant's exercise of its right to extend the Lease Term, or the fact that landlords are or are not paying real estate brokerage commissions in connection with such comparable space. The Concessions shall be reflected in the effective rental rate (which effective rental rate shall take into consideration the total dollar value of such Concessions as amortized on a straight-line basis over the applicable term of the Comparable Transaction (in which case such Concessions evidenced in the effective rental rate shall not be granted to Tenant)) payable by Tenant. The term "Comparable Buildings" shall mean the Building and those other life sciences and or laboratory buildings which are comparable to the Building in terms of age (based upon the date of completion of construction or major renovation of the building), quality of construction, level of services and amenities, size and appearance, and are located in Sorrento Mesa submarket and the surrounding commercial area.
  • Determination of Option Rent. In the event Tenant timely and appropriately exercises its option to extend the Lease Term, Landlord shall notify Tenant of Landlord's determination of the Option Rent within thirty (30) days thereafter. If Tenant, on or before the date which is ten (10) business days following the date upon which Tenant receives Landlord's determination of the Option Rent, in good faith objects to Landlord's determination of the Option Rent, then Landlord and Tenant shall attempt to agree upon the Option Rent using their best good-faith efforts. If Landlord and Tenant fail to reach agreement within ten (10) business days following Tenant's objection to the Option Rent (the "Outside Agreement Date"), then each party shall thereafter make a separate determination of the Option Rent, as the case may be, within ten (10) business days after the Outside Agreement Date, and such determinations shall be submitted to arbitration in accordance with Sections 2.2.3.1 through 2.2.3.7, below. If Tenant fails to accept or reject Landlord's determination of the Option Rent within the time period set forth herein, then Tenant shall be deemed to have objected to Landlord's determination of Option Rent, and each party shall make their separate determinations of Option Rent and the matter shall be submitted to arbitration in accordance with the terms hereof.
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  • Landlord and Tenant shall each appoint one arbitrator who shall by profession be a real estate appraiser who shall have been active over the five (5) year period ending on the date of such appointment in the appraisal of other First Class Life Sciences Projects located in the Sorrento Mesa submarket. The determination of the arbitrators shall be limited solely to the issue of whether Landlord's or Tenant's submitted Option Rent is the closest to the actual Option Rent, taking into account the requirements of Section 2.2.2 of this Lease, as determined by the arbitrators. Each such arbitrator shall be appointed within fifteen (15) business days after the Outside Agreement Date. Landlord and Tenant may consult with their selected arbitrators prior to appointment and may select an arbitrator who is favorable to their respective positions (including an arbitrator who has previously represented Landlord and/or Tenant, as applicable). The arbitrators so selected by Landlord and Tenant shall be deemed "Advocate Arbitrators."
  • The two (2) Advocate Arbitrators so appointed shall be specifically required pursuant to an engagement letter within ten (10) business days of the date of the appointment of the last appointed Advocate Arbitrator to agree upon and appoint a third arbitrator ("Neutral Arbitrator") who shall be qualified under the same criteria set forth hereinabove for qualification of the two Advocate Arbitrators, except that neither the Landlord or Tenant or either parties' Advocate Arbitrator may, directly or indirectly, consult with the Neutral Arbitrator prior or subsequent to his or her appointment, and the Neutral Arbitrator cannot be someone who has represented Landlord and/or Tenant during the five (5) year period prior to such appointment. The Neutral Arbitrator shall be retained via an engagement letter jointly prepared by Landlord's counsel and Tenant's counsel.
  • The three arbitrators shall, within thirty (30) days of the appointment of the Neutral Arbitrator, reach a decision as to whether the parties shall use Landlord's or Tenant's submitted Option Rent, and shall notify Landlord and Tenant thereof.
  • The decision of the majority of the three arbitrators shall be binding upon Landlord and Tenant.
  • If either Landlord or Tenant fails to appoint an Advocate Arbitrator within fifteen (15) days after the Outside Agreement Date, then either party may petition the presiding judge of the Superior Court of San Diego County to appoint such Advocate Arbitrator subject to the criteria in Section 2.2.3.1 of this Lease, or if he or she refuses to act, either party may petition any judge having jurisdiction over the parties to appoint such Advocate Arbitrator.
  • If the two (2) Advocate Arbitrators fail to agree upon and appoint the Neutral Arbitrator within ten (10) business days after the appointment of the last appointed Advocate Arbitrator, then either party may petition the presiding judge of the Superior Court of San Diego County to appoint the Neutral Arbitrator, subject to criteria in Section 2.2.3.1 of this Lease, or if he or she refuses to act, either party may petition any judge having jurisdiction over the parties to appoint such arbitrator.
  • The cost of the arbitration shall be paid by Landlord and Tenant equally.
  • In the event that the Option Rent shall not have been determined pursuant to the terms hereof prior to the commencement of the Option Term, Tenant shall be required to pay the Option Rent at 103% of the rate in effect on the last day of the initial Lease Term, and upon the final determination of the Option Rent, the payments made by Tenant shall be reconciled with the actual amounts of Option Rent due, and the appropriate party shall make any corresponding payment to the other party.
  • Tenant Early Termination Right. Subject to the terms of this Section 2.3 below, Tenant shall have the one-time right (the "Early Termination Right") to terminate this Lease in its entirety effective as of the last day of the sixty-sixth (66th) full calendar month of the initial Lease Term (the "Termination Date"), upon not less than twelve (12) months prior written notice to Landlord (the "Termination Notice") irrevocably exercising the Early Termination Right. Concurrently with Tenant's delivery of the Termination Notice to Landlord, as consideration for and as a condition precedent to such early termination, Tenant shall pay to Landlord the Termination Fee (defined below). The "Termination Fee" shall be equal to eight (8) months’ worth of Base Rent and Estimated Direct Expenses based upon the amount of Base Rent and Estimated Direct Expenses due for the fifty-fourth (54th) full calendar month of the initial Lease Term; provided, however, Tenant agrees that (i) such eight (8) months' worth of Base Rent and
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  • Estimated Direct Expenses is not in the nature of a penalty and represents the value of other unamortized economic concessions granted to Tenant under this Lease, as well as consideration for the uncertainty in the amount of time Landlord will require in order to re-lease the Premises, and (ii) for the avoidance of doubt, Tenant’s payment of such Termination Fee shall not be deemed to relieve Tenant of its obligation to pay Landlord Base Rent and Estimated Direct Expenses as provided in the penultimate sentence of this Section 2.3. Time is of the essence with respect to the delivery of the Termination Notice and Termination Fee. In no event shall Tenant be entitled to exercise the Early Termination Right if an Event of Default by Tenant under this Lease remains uncured at the time of Landlord's receipt of the Termination Notice, or at Landlord's option, at the Termination Date. Provided Tenant properly exercises (and is entitled to exercise) the Early Termination Right in accordance with the terms of this Section 2.3, then, effective as of the Termination Date, this Lease shall automatically terminate and be of no further force or effect, and Landlord and Tenant shall be relieved of their respective obligations under this Lease, except those obligations set forth in this Lease with respect to the period of Tenant's tenancy through the Termination Date or such obligations which specifically survive the expiration or earlier termination of this Lease, including, without limitation, the payment by Tenant of all amounts owed by Tenant under this Lease up to and including the Termination Date. The Early Termination Right shall be personal to the Original Tenant and Permitted Assignees, and may only be exercised by the Original Tenant and Permitted Assignees (and not any other assignee, sublessee or other transferee of the Original Tenant's interest in this Lease).
  • BASE RENT
  • In General. Tenant shall pay to Landlord, without prior notice or demand, base rent ("Base Rent") as set forth in Section 4 of the Summary, payable in monthly installments as set forth in Section 4 of the Summary in advance on or before the first day of each and every calendar month during the Lease Term, without any setoff or deduction whatsoever. In accordance with Section 4 of the Summary, any increases in Base Rent shall occur on the first (1st) day of the applicable Lease Month. However, if the first Lease Month pertains to a period longer than one (1) calendar month, then Base Rent for such first Lease Month shall be equal to one (1) calendar month's Base Rent plus prorated Base Rent for the partial calendar month also included in such first (1st) Lease Month. The prepaid Base Rent set forth in Section 14 of the Summary shall be paid at the time of Tenant's execution and delivery of this Lease. All payments required to be made by Tenant to Landlord hereunder (including, without limitation, Base Rent) shall be paid to Landlord or Landlord's agent, at Tenant's option, by wire transfer, Electronic Funds Transfer, or at the management office of the Project or at such other place or method as Landlord may from time to time designate in writing, in immediately available funds that, at the time of payment, are legal tender for private or public debts in the United States of America. If no time period for payment is specified in this Lease, Tenant shall make all required payments within thirty (30) days of Landlord's request and delivery of an invoice.
  • Base Rent Abatement. Subject to the terms and conditions of this Lease, Tenant shall not be obligated to pay any Base Rent otherwise attributable to the Premises with respect to the following full calendar months two (2) through fourteen (14) (collectively, the "Base Rent Abatement"). The maximum aggregate amount of the Base Rent Abatement shall be equal to $2,399,031 (i.e., $183,693.00 per month for months two (2) through twelve (12) and $189,204.00 per month for months thirteen (13) and fourteen (14)).
  • ADDITIONAL RENT
  • General Terms.
  • Direct Expenses; Additional Rent. In addition to paying the Base Rent specified in Article 3 of this Lease, Tenant shall pay "Tenant's Share" of the annual "Direct Expenses," as those terms are defined in Sections 4.2.5 and 4.2.1 of this Lease, respectively. Such payments by Tenant, together with any and all other amounts payable by Tenant to Landlord pursuant to the terms of this Lease, are hereinafter collectively referred to as the "Additional Rent," and the Base Rent and the Additional Rent are herein collectively referred to as "Rent." All amounts due under this Article 4 as Additional Rent shall be payable for the same periods and in the same manner as the Base Rent. Without limitation on other obligations of Tenant which survive the expiration of the Lease Term, the obligations of Tenant to pay the Additional Rent provided for in this Article 4 shall survive the expiration of the Lease Term.
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  • Triple Net Lease. Landlord and Tenant acknowledge that, except as otherwise provided to the contrary in this Lease, it is their intent and agreement that this Lease be a "TRIPLE net" lease and that as such, the provisions contained in this Lease are intended to pass on to Tenant or reimburse Landlord for the costs and expenses reasonably associated with this Lease, the Building and the Project, and Tenant's operation therefrom. To the extent such costs and expenses payable by Tenant cannot be charged directly to, and paid by, Tenant, such costs and expenses shall be paid by Landlord but reimbursed by Tenant as Additional Rent.
  • Definitions of Key Terms Relating to Additional Rent. As used in this Article 4, the following terms shall have the meanings hereinafter set forth:
  • "Direct Expenses" shall mean "Operating Expenses" and "Tax Expenses."
  • "Expense Year" shall mean each calendar year in which any portion of the Lease Term falls, through and including the calendar year in which the Lease Term expires, provided that Landlord, upon written notice to Tenant, may change the Expense Year from time to time to any other twelve (12) consecutive month period, and, in the event of any such change, Tenant's Share of Direct Expenses shall be equitably adjusted for any Expense Year involved in any such change.
  • Except as expressly set forth to the contrary herein, "Operating Expenses" shall mean all expenses, costs and amounts of every kind and nature which Landlord pays, accrues or amortizes during any Expense Year because of or in connection with the ownership, management, maintenance, security, repair, replacement, renovation, restoration or operation of the Project or any portion thereof (including, without limitation, all Common Areas and the Amenity Space), in accordance with sound real estate management and accounting practices. Without limiting the generality of the foregoing, Operating Expenses shall specifically include any and all of the following: (i) the cost of supplying all utilities, the cost of operating, repairing, replacing, maintaining, renovating and restoring the utility, telephone, mechanical, sanitary, storm drainage, and elevator systems, and the cost of maintenance and service contracts in connection therewith; (ii) the cost of licenses, certificates, permits and inspections and the cost of contesting any governmental enactments which may affect Operating Expenses, and the costs incurred in connection with a governmentally mandated transportation system management program or similar program; (iii) the cost of all insurance carried by Landlord in connection with the Project and Premises as reasonably determined by Landlord; (iv) the cost of landscaping, relamping, and all supplies, tools, equipment and materials used in the operation, repair and maintenance of the Project, or any portion thereof; (v) the cost of parking area operation, repair, restoration, and maintenance; (vi) fees and other costs, including management and/or incentive fees, consulting fees, contractor fees, legal fees and accounting fees in connection with the management, operation, maintenance, replacement, renovation, repair and restoration of the Project; (vii) payments under any equipment rental agreements; (viii) subject to item (f), below, wages, salaries and other compensation and benefits, including taxes levied thereon, of all persons engaged in the operation, maintenance and security of the Project; (ix) rent or imputed rent for any office space made available for Project management personnel; (x) operation, repair, maintenance and replacement of all systems and equipment and components thereof of the Project, subject to Section 1.1.1 above and provided that any capital expenditures for the same shall be amortized in accordance with (xiii) below; (xi) the cost of janitorial, alarm, security and other services, replacement of wall and floor coverings, ceiling tiles and fixtures in common areas, maintenance and replacement of curbs and walkways, repair to roofs and re-roofing, provided that any capital expenditures for the same shall be amortized in accordance with (xiii) below; (xii) amortization (including interest on the unamortized cost) over the useful life or rental period in accordance with generally accepted accounting principles, of the cost of acquiring or the rental expense of personal property used in the maintenance, operation and repair of the Project, or any portion thereof; (xiii) the cost of capital improvements or other costs incurred in connection with the Project (A) which are intended to effect economies in the operation or maintenance of the Project, or any portion thereof, or to reduce current or future Operating Expenses (but only to the extent of reasonably anticipated savings in Operating Expenses on a net basis in connection with such particular capital improvement) or to enhance the safety or security of the Project or its occupants, (B) that are required to comply with present or future mandatory conservation programs, (C) intentionally omitted, (D) that are reasonably necessary for the continued operation of the Project as a First Class Life Sciences Project, (E) that are required under any Applicable Laws (as defined in Section 24.1 of this Lease) provided that such law or regulation was not enacted or enforced prior to the Commencement Date, (F) reasonably necessary (as reasonably determined by Landlord) for the safety or security of the Project, or (G) replacements or modifications of equipment or other items located in or serving the Common Areas required to keep the Common Areas in good order or condition (the foregoing items (A) through (G) to be referred to as the "Permitted Capital Costs"); provided,
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  • however, that any capital expenditure shall be amortized with interest at the "Interest Rate" (as that term is defined in Article 25 below) over its useful life as Landlord shall reasonably determine in accordance with sound real estate management and accounting practices (provided, however, with respect to those items included under item (A) above, Landlord shall have the right to amortize the same over their recovery/payback period as Landlord shall reasonably determine in accordance with sound real estate management and accounting practices); and (xiv) costs, fees, charges or assessments imposed by, or resulting from any mandate imposed on Landlord by, any federal, state or local government for fire and police protection, trash removal, community services, or other services which do not constitute "Tax Expenses" as that term is defined in Section 4.2.4, below, (xv) cost of tenant relation programs reasonably established by Landlord, and (xvi) payments under any easement, license, operating agreement, declaration, restrictive covenant, or instrument pertaining to the sharing of costs by the Building, including, without limitation, any covenants, conditions and restrictions affecting the property, and reciprocal easement agreements affecting the property, any parking licenses, and any agreements with transit agencies affecting the Property (collectively, "Underlying Documents"), except to the extent resulting from Landlord's violation of any Underlying Document (to the extent not caused by Tenant's or Tenant's Party's own violation of the terms of this Lease or such Underlying Documents).

Notwithstanding the foregoing, for purposes of this Lease, Operating Expenses shall not, however, include:

  • costs, including legal fees, space planners' fees, advertising and promotional expenses (except as otherwise set forth above), tenant relocation costs, and brokerage fees incurred in connection with the original construction or development, or original or future leasing of the Project, and costs, including permit, license and inspection costs, incurred with respect to the installation of tenant improvements made for new tenants initially occupying space in the Project after the Lease Commencement Date or incurred in renovating or otherwise improving, decorating, painting or redecorating vacant space for tenants or other occupants of the Project (excluding, however, such costs relating to any common areas of the Project or parking facilities);
  • except in connection with items (xii) and (xiii) above, depreciation, interest and principal payments on mortgages and other debt costs, if any, penalties and interest;
  • costs for which the Landlord is reimbursed by any tenant or occupant of the Project or by insurance by its carrier or any tenant's carrier or by anyone else (except to the extent of deductibles), and utility costs for which any tenant directly contracts with the local public service company;
  • any bad debt loss, rent loss, or reserves for bad debts or rent loss;
  • costs associated with the operation of the business of the partnership or entity which constitutes the Landlord, as the same are distinguished from the costs of operation of the Project (which shall specifically include, but not be limited to, accounting costs associated with the operation of the Project). Costs associated with the operation of the business of the partnership or entity which constitutes the Landlord include costs of partnership accounting and legal matters, costs of defending any lawsuits with any mortgagee (except as the actions of the Tenant may be in issue), costs of selling, syndicating, financing, mortgaging or hypothecating the Project or any of the Landlord's interest in the Project, and costs incurred in connection with any disputes between Landlord and its employees, between Landlord and Project management, or between Landlord and other tenants or occupants;
  • the wages and benefits of any employee who does not devote substantially all of his or her employed time to the Project unless such wages and benefits are prorated to reflect time spent on operating and managing the Project vis-à-vis time spent on matters unrelated to operating and managing the Project; provided, that in no event shall Operating Expenses include wages and/or benefits attributable to personnel above the level of a senior portfolio manager, or its equivalent;
  • amount paid as ground rental for the Project by the Landlord;
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  • except for a management fee, overhead and profit increment paid to the Landlord or to subsidiaries or affiliates of the Landlord for services in the Project to the extent the same exceeds the costs of such services rendered by qualified, first-class unaffiliated third parties;
  • any compensation paid to clerks, attendants or other persons in commercial concessions operated by the Landlord, provided that any compensation paid to any concierge or parking attendants at the Project shall be includable as an Operating Expense;
  • rentals and other related expenses incurred in leasing air conditioning systems, elevators or other equipment which if purchased the cost of which would be excluded from Operating Expenses as a capital cost, except equipment not affixed to the Project which is used in providing engineering, janitorial or similar services and, further excepting from this exclusion such equipment rented or leased to remedy or ameliorate an emergency condition in the Project;
  • all items and services for which Tenant or any other tenant in the Project reimburses Landlord directly and separately from Operating Expenses, or which Landlord provides selectively to one or more tenants (other than Tenant) without reimbursement;
  • any costs expressly excluded from Operating Expenses elsewhere in this Lease;
  • rent or imputed rent for any office space occupied by Project management personnel to the extent the size or rental rate of such office space exceeds the size or fair market rental value of office space occupied by management personnel of the comparable buildings in the vicinity of the Building, with adjustment where appropriate for the size of the applicable project;
  • costs arising from the gross negligence or willful misconduct of Landlord, its agents, employees, and/or contractors, in connection with this Lease;
  • costs incurred to comply with Applicable Laws relating to the removal of "Hazardous Material" (as defined in Section 5.3 below) that was in existence in the Building or on the Project prior to the Lease Commencement Date, or that was brought into the Building or onto the Project after the Lease Commencement Date by Landlord or any other "Landlord Parties" (as that term is defined in Section 10.1 below) or by other parties other than Tenant or any Tenant Parties, and was of such a nature that a federal, state, local or municipal governmental authority would have required removal or other containment, if it had then had knowledge of the presence of such hazardous material, in the state, and under the conditions that it then existed in the Building or on the Project, but only to the extent those Applicable Laws were then being actively enforced by the applicable government authority;
  • capital expenditures other than Permitted Capital Costs;
  • except as provided herein, attorney's fees and other costs and expenses incurred in connection with negotiations or disputes with present or prospective tenants, other occupants of the Building, or other third parties;
  • interest, principal, points and fees on debt or amortization on any mortgage or mortgages or any other debt instrument encumbering the Building or Project;
  • costs of acquisition and maintenance of sculptures, paintings, or other objects of art;
  • except as provided herein, leasing commissions, attorneys' fees and other costs and expenses incurred in connection with negotiations or disputes with present or prospective tenants, other occupants of the Building, or other third parties;
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  • Landlord's general corporate overhead and administrative expenses, except for the property management fee (subject to clause (gg) below) and except as they relate to the specific management of the Project;
  • the cost of special services, goods or materials provided to any other tenant of the Project, and not provided to Tenant;
  • costs of correcting any defects in the initial design or construction of the Building or Common Areas;
  • costs or fees incurred in connection with the defense of Landlord's title or interest in the real estate containing the Project, except (1) as otherwise specifically enumerated as a part of Operating Expenses in this Lease or (2) as and to the extent the expenditure of such attorneys' fees generally benefits the tenants of the Building and/or Project;
  • fees, penalties and interest resulting from Landlord's failure to pay an Operating Expense as and when due and which are not caused by Tenant and/or any Tenant Parties;
  • costs and overhead and profit increment paid to Landlord or to subsidiaries or affiliates of Landlord for goods and/or services in or to the Project to the extent the same exceeds typical costs and overhead and profit increment of such goods and/or services rendered by qualified unaffiliated third parties on a competitive basis;
  • costs of advertising, public relations and promotional costs associated with the promotion or leasing of the Building, and costs of signs (other than building directories and signage for various equipment rooms and common areas) in or on the Building which identify other tenants and/or Landlord;
  • rentals and other related expenses incurred in leasing air conditioning systems, elevators or other equipment (except when needed in connection with normal repairs and maintenance of the Project and/or to ameliorate an emergency condition in the Buildings) which if purchased, rather than rented, would constitute a capital improvement not included in Operating Expenses pursuant to this Lease, excluding, however, equipment not affixed in the Building or Project which is used in providing janitorial or similar services;
  • costs of any capital repairs made by Landlord because of the total or partial destruction of the Building or the condemnation of a portion of the Building, except for commercially reasonable deductible amounts;
  • costs of overtime or other expense to Landlord due to Landlord's defaults under this Lease or incurred while performing work expressly provided in this Lease to be borne at Landlord's sole cost and expense (and not as a part of Operating Expenses);
  • costs incurred for any items to the extent Landlord actually recovers under a manufacturer's, materialmen's vendor's or contractor's warranty;
  • costs incurred due to the gross negligence or willful misconduct of Landlord, its agents, employees, or contractors; and
  • fees payable by Landlord for management of the Project in excess of three percent (3%) (the "Management Fee Cap") of Landlord’s gross revenues, adjusted and grossed up to reflect a one hundred percent (100%) occupancy of the Project with all tenants paying full rent, as contrasted with free rent, half-rent and the like (but excluding any period that a tenant is not required to pay rent, if any, specifically in connection with the design, permitting and construction of tenant improvements in such
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  • tenant's space), including base rent, pass-throughs, and parking fees (but excluding the cost of after-hours services or utilities) from the Project for any calendar year or portion thereof; and
  • any reserve funds.

If Landlord is not furnishing any particular work or service (the cost of which, if performed by Landlord, would be included in Operating Expenses) to a tenant who has undertaken to perform such work or service in lieu of the performance thereof by Landlord, Operating Expenses shall be deemed to be increased by an amount equal to the additional Operating Expenses which would reasonably have been incurred during such period by Landlord if it had at its own expense furnished such work or service to such tenant. If the Project is not at least one hundred percent (100%) occupied during all or a portion of any Expense Year, Landlord shall make an appropriate adjustment to the components of Operating Expenses for such year to determine the amount of Operating Expenses that would have been incurred had the Project been one hundred percent (100%) occupied; and the amount so determined shall be deemed to have been the amount of Operating Expenses for such year. Operating Expenses shall be reduced by all cash discounts, trade discounts or quantity discounts actually received by Landlord or Landlord's managing agent in the purchase of any goods, utilities or services in connection with the prudent operation of the Project. In the calculation of any expenses hereunder, it is understood that no expense shall be charged more than once. Landlord shall use its commercially reasonable efforts in good faith to effect an equitable proration of bills for services rendered to the Project. To the extent there exists a conflict as to an expense which is specified to be included in Operating Expenses and is also specified to be excluded from Operating Expenses within the above list, the exclusions listed above shall prevail and the expenses shall be deemed excluded. Landlord shall not recover more than one hundred percent (100%) of the Operating Expenses actually incurred by Landlord.

Notwithstanding the foregoing, Controllable Expenses (as defined below) for each Expense Year (the "Applicable Expense Year"), commencing with the Expense Year following the Expense Year 2026, shall not exceed an amount determined by increasing Controllable Expenses for each prior Expense Year at the rate of five percent (5%) per year through the Applicable Expense Year on a compounded and cumulative basis. "Controllable Expenses" shall mean those Operating Expenses that are reasonably controllable by Landlord. Operating Expenses that are not reasonably controllable by Landlord shall include those Operating Expenses relating to Tax Expenses, insurance, utilities, collectively-bargained union wages and costs, property management fees, ground lease payments or assessments due under any recorded document (if applicable), janitorial, costs incurred due to an event of Force Majeure, and other weather-related costs (e.g., snow and ice removal), capital improvements and alterations and modifications to the Building required by Applicable Law or any costs incurred specifically at the request of Tenant (such as for additional or special services) and not expressly required to be incurred by Landlord pursuant to this Lease.

Landlord shall not (a) make a profit by charging items to Operating Expenses that are otherwise also charged separately (i.e., not as the equivalent to Operating Expenses under this Lease) to Tenant (or other tenants of the Project, if applicable), and (b) except for a management fee, and subject to Landlord's obligation to reconcile Operating Expenses described in this Article 4, collect Operating Expenses from Tenant (and all other tenants in the Project, if applicable) in an amount in excess of what Landlord incurs for the items included in Operating Expenses.

  • Tax Expenses.
  • Inclusions. Subject to the terms of Section 4.2.4.2 below, "Tax Expenses" shall mean all federal, state, county, or local governmental or municipal taxes, fees, charges or other impositions of every kind and nature, whether general, special, ordinary or extraordinary (including, without limitation, real estate taxes, general and special assessments, transit taxes, leasehold taxes or taxes based upon the receipt of rent, including gross receipts or sales taxes applicable to the receipt of rent, personal property taxes imposed upon the fixtures, machinery, equipment, apparatus, systems and equipment, appurtenances, furniture and other personal property used in connection with the Project, or any portion thereof, to the extent not attributable to the personal property of another tenant of the Project), which shall be paid or accrued during any Expense Year (without regard to any different fiscal year used by such governmental or municipal authority) because of or in connection with the ownership, leasing and operation of the Project, or any portion thereof, including, without limitation: (i) any tax on the rent, right to rent or other income from the Project, or any portion thereof, or as against the business of leasing the Project, or any portion thereof; (ii) any assessment, tax, fee, levy or charge in addition to, or in substitution, partially or totally, of any
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  • assessment, tax, fee, levy or charge previously included within the definition of real property tax, it being acknowledged by Tenant and Landlord that Proposition 13 was adopted by the voters of the State of California in the June 1978 election ("Proposition 13") and that assessments, taxes, fees, levies and charges may be imposed by governmental agencies for such services as fire protection, street, sidewalk and road maintenance, refuse removal and for other governmental services formerly provided without charge to property owners or occupants, and, in further recognition of the decrease in the level and quality of governmental services and amenities as a result of Proposition 13; (iii) any governmental or private assessments or the Project's contribution towards a governmental or private cost-sharing agreement for the purpose of augmenting or improving the quality of services and amenities normally provided by governmental agencies; (iv) any assessment, tax, fee, levy, or charge allocable to or measured by the area of the Premises or the Rent payable hereunder, including, without limitation, any business or gross income tax or excise tax with respect to the receipt of such rent, or upon or with respect to the possession, leasing, operating, management, maintenance, alteration, repair, use or occupancy by Tenant of the Premises, or any portion thereof; (v) any assessment, tax, fee, levy or charge, upon this transaction or any document to which Tenant is a party, creating or transferring an interest or an estate in the Premises; and (vi) all of the real estate taxes and assessments imposed upon or with respect to the Building and all of the real estate taxes and assessments imposed on the land and improvements comprising the Project.
  • In General. Any costs and expenses (including, without limitation, reasonable attorneys' and consultants' fees) incurred in attempting to protest, reduce or minimize Tax Expenses shall be included in Tax Expenses in the Expense Year such expenses are paid. Tax refunds shall be credited against Tax Expenses and refunded to Tenant regardless of when received, based on the Expense Year to which the refund is applicable, provided that in no event shall the amount to be refunded to Tenant for any such Expense Year exceed the total amount paid by Tenant as Additional Rent under this Article 4 for such Expense Year. If Tax Expenses for any period during the Lease Term or any extension thereof are increased after payment thereof for any reason, including, without limitation, error or reassessment by applicable governmental or municipal authorities, Tenant shall pay Landlord within thirty (30) days of Landlord's written request for the same, together with reasonable supporting documentation of such change, Tenant's Share of any such increased Tax Expenses. Notwithstanding anything to the contrary contained in this Section 4.2.5, there shall be excluded from Tax Expenses (i) all excess profits taxes, franchise taxes, gift taxes, capital stock taxes, inheritance and succession taxes, estate taxes, federal and state income taxes, taxes upon business professional, occupational and license taxes (BPOL), (ii) other taxes to the extent applicable to Landlord's net income (as opposed to rents, receipts or income attributable to operations at the Project), (iii) any items included as Operating Expenses, (iv) any items paid by Tenant under Section 4.5 of this Lease, (v) assessments in excess of the amount which would be payable if such assessment expense were paid in installments over the longest permitted term, (vi) taxes imposed on land and improvements other than the Project, and (vii) any mortgaging or refinancing of the Building or Project. Landlord shall not include in Tax Expenses any interest or penalties incurred by Landlord by reason of Landlord's failure to pay in a timely manner any Tax Expenses.
  • "Tenant's Share" shall mean the percentage set forth in Section 6 of the Summary.
  • Intentionally Deleted.
  • Calculation and Payment of Additional Rent. Tenant shall pay to Landlord, in the manner set forth in Section 4.4.1, below, and as Additional Rent, Tenant's Share of Direct Expenses for each Expense Year.
  • Statement of Actual Direct Expenses and Payment by Tenant. Landlord shall give to Tenant following the end of each Expense Year, a reasonably detailed statement (the "Statement") which shall state in general major categories the Direct Expenses incurred or accrued for the particular Expense Year, and which shall indicate the amount of Tenant's Share of Direct Expenses. Landlord shall deliver such Statement to Tenant following the end of each Expense Year and shall use commercially reasonable efforts to deliver the same to Tenant within six (6) months following the end of the applicable Expense Year. Upon receipt of the Statement for each Expense Year commencing or ending during the Lease Term, Tenant shall pay, with its next installment of Base Rent due, the full amount of Tenant's Share of Direct Expenses for such Expense Year, less the amounts, if any, paid during such Expense Year as "Estimated Direct Expenses," as that term is defined in Section 4.4.2, below, and if Tenant paid more as Estimated Direct Expenses than the actual Tenant's Share of Direct Expenses, Tenant shall receive a credit in the amount of Tenant's overpayment against Rent next due under this Lease or, if the Lease Term has ended, Landlord shall refund such overpayment to Tenant within thirty (30) days of the date such Statement is delivered to Tenant.
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  • Subject to the penultimate sentence of this Section 4.4.1, the failure of Landlord to timely furnish the Statement for any Expense Year shall not prejudice Landlord or Tenant from enforcing its rights under this Article 4. Even though the Lease Term has expired and Tenant has vacated the Premises, when the final determination is made of Tenant's Share of Direct Expenses for the Expense Year in which this Lease terminates, Tenant shall pay to Landlord such amount within thirty (30) days of its receipt of the applicable Statement, and if Tenant paid more as Estimated Direct Expenses than the actual Tenant's Share of Direct Expenses, Landlord shall apply such overpayment against any unpaid Rent, and within thirty (30) days, deliver a check payable to Tenant in the amount of any remaining overpayment. Notwithstanding the immediately preceding sentence, Tenant shall not be responsible for Tenant's Share of any Direct Expenses attributable to any Expense Year which are first billed to Tenant more than twenty-four (24) months after the Expense Year in which the same were incurred, provided that in any event Tenant shall be responsible for Tenant's Share of Direct Expenses levied by any governmental authority or by any public utility companies at any time following such Expense Year, and Tenant shall not be responsible for Tenant's Share of any Direct Expenses attributable to any Expense Year which are first billed to Tenant more than fifteen (15) months after the Lease Expiration Date (or any earlier expiration or termination of this Lease), provided that in any event Tenant shall be responsible for Tenant's Share of Direct Expenses levied by any governmental authority or by any public utility companies at any time following the Lease Expiration Date which are attributable to any Expense Year. The provisions of this Section 4.4.1 shall survive the expiration or earlier termination of the Lease Term.
  • Statement of Estimated Direct Expenses. In addition, Landlord shall give Tenant a yearly expense estimate statement (the "Estimate Statement") which shall set forth in reasonable detail Landlord's reasonable estimate (the "Estimate") of what the total amount of Direct Expenses for the then-current Expense Year shall be and the estimated Tenant's Share of Direct Expenses (the "Estimated Direct Expenses"). The failure of Landlord to timely furnish the Estimate Statement for any Expense Year shall not preclude Landlord from enforcing its rights to collect any Estimated Direct Expenses under this Article 4, nor shall Landlord be prohibited from revising any Estimate Statement or Estimated Direct Expenses theretofore delivered to the extent necessary. Thereafter, Tenant shall pay, within thirty (30) days after receipt of the Estimate Statement), a fraction of the Estimated Direct Expenses for the then-current Expense Year (reduced by any amounts paid pursuant to the second to last sentence of this Section 4.4.2). Such fraction shall have as its numerator the number of months which have elapsed in such current Expense Year, including the month of such payment, and twelve (12) as its denominator. Until a new Estimate Statement is furnished (which Landlord shall have the right to deliver to Tenant at any time, but not more than twice per Expense Year), Tenant shall pay monthly, with the monthly Base Rent installments, an amount equal to one-twelfth (1/12) of the total Estimated Direct Expenses set forth in the previous Estimate Statement delivered by Landlord to Tenant. Throughout the Lease Term, Landlord shall maintain records with respect to Direct Expenses in accordance with Landlord's customary, sound real estate management and accounting practices.
  • Taxes and Other Charges for Which Tenant Is Directly Responsible. Tenant shall be liable for and shall pay on or before the applicable due date, taxes levied against Tenant's equipment, furniture, fixtures and any other personal property located in or about the Project. If any such taxes on Tenant's equipment, furniture, fixtures and any other personal property are levied against Landlord or Landlord's property or if the assessed value of Landlord's property is increased by the inclusion therein of a value placed upon such equipment, furniture, fixtures or any other personal property and if Landlord pays the taxes based upon such increased assessment, which Landlord shall have the right to do regardless of the validity thereof but only under proper protest if requested by Tenant, Tenant shall within thirty (30) days of Landlord's demand repay to Landlord the taxes so levied against Landlord or the proportion of such taxes resulting from such increase in the assessment, as the case may be. If the tenant improvements in the Premises, whether installed and/or paid for by Landlord or Tenant and whether or not affixed to the real property so as to become a part thereof, are assessed for real property tax purposes at a valuation higher than the valuation at which tenant improvements conforming to Landlord's "building standard" in other space in the Building are assessed, then the Tax Expenses levied against Landlord or the property by reason of such excess assessed valuation shall be deemed to be taxes levied against personal property of Tenant and shall be governed by the provisions of Section 4.5, above.
  • Landlord's Records. Upon Tenant's written request given not more than one hundred twenty (120) days after Tenant's receipt of a Statement for a particular Expense Year, and provided that no Event of Default is then occurring under this Lease, Landlord shall furnish Tenant with such reasonable supporting documentation as Tenant may reasonably request in connection with the calculation of Direct Expenses as set forth in such Statement (to the extent Landlord has such supporting documentation readily available, and to the extent such supporting documentation
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  • is reasonably required to substantiate Direct Expenses charged to Tenant). Landlord shall provide said documentation to Tenant within sixty (60) days after Tenant's written request therefor. Within one hundred eighty (180) days after Tenant's receipt of a Statement for a particular Expense Year (the "Audit Period"), if Tenant disputes the calculation of Direct Expenses set forth in such Statement, an independent certified public accountant designated and paid for by Tenant ("Tenant's Accountant"), may after reasonable notice to Landlord and at reasonable times, audit Landlord's records with respect to the Statement, provided that (i) no Event of Default is then occurring under this Lease, (ii) Tenant has paid all amounts required to be paid under the applicable Estimate Statement and Statement, and (iii) a copy of the audit agreement between Tenant and Tenant's Accountant has been delivered to Landlord prior to the commencement of the audit. Tenant's Accountant must (A) be a member of a nationally or regionally recognized certified public accounting firm which has previous experience in auditing financial operating records of landlords of comparable projects, (B) not already be providing accounting and/or lease administration services to Tenant or Landlord and shall not have provided accounting and/or lease administration services to Tenant or Landlord in the past three (3) years, (C) not be retained on a contingency fee basis (i.e., Tenant must be billed based on the actual time and materials that are incurred by Tenant's Accountant in the performance of the audit), and (D) not currently or within the previous twenty-four (24) month period be providing accounting and/or lease administration services to another tenant in the Project in connection with a review or audit by such other tenant of Direct Expenses. In connection with such audit, Tenant and Tenant's Accountant must agree in advance to follow Landlord's reasonable rules and procedures regarding an audit of the aforementioned Landlord records, and shall execute a commercially reasonable confidentiality agreement regarding such audit. Any audit report prepared by Tenant's Accountant shall be delivered concurrently to Landlord and Tenant within the Audit Period. Tenant's failure to audit the Direct Expenses set forth in any Statement within the Audit Period shall be deemed to be Tenant's approval of such Statement and Tenant, thereafter, waives the right or ability to audit the amounts set forth in such Statement. If after such audit, Tenant still disputes such Direct Expenses, an audit to determine the proper amount shall be made, at Tenant's expense, by an independent certified public accountant (the "Neutral Accountant") selected by Landlord and subject to Tenant's reasonable approval; provided that if such audit by the Neutral Accountant proves that the Direct Expenses in the subject Expense Year were overstated by more than five percent (5%), then the cost of the Neutral Accountant and the out-of-pocket cost of Tenant's Accountant shall be paid for by Landlord. Tenant's sole right to audit Landlord's records and to contest the amount of Direct Expenses with respect to any Expense Year shall be as expressly set forth in this Section 4.6, and Tenant hereby waives any and all other rights pursuant to Applicable Laws to audit such records and/or to contest the amount of Direct Expenses with respect to any Expense Year, (except with respect to claims of fraud or intentional misrepresentation that are not waivable under Applicable Laws).
  • USE OF PREMISES
  • Permitted Use. Tenant shall use the Premises solely for the Permitted Use set forth in Section 7 of the Summary and Tenant shall not use or permit the Premises or the Project to be used for any other purpose or purposes whatsoever without the prior written consent of Landlord, which may be withheld in Landlord's sole and absolute discretion.
  • Prohibited Uses. Tenant further covenants and agrees that Tenant shall not use, or suffer or permit any person or persons to use, the Premises or any part thereof for any use or purpose in violation of the laws of the United States of America, the State of California, or the ordinances, regulations or requirements of the local municipal or county governing body or other lawful authorities having jurisdiction over the Project) including, without limitation, any such laws, ordinances, regulations or requirements relating to hazardous materials or substances, as those terms are defined by Applicable Laws now or hereafter in effect, or any Underlying Documents. Landlord shall have the right to impose reasonable and customary non-discriminatory rules and regulations regarding the use of the Project, as reasonably deemed necessary by Landlord with respect to the orderly operation of the Project, and Tenant shall comply with such reasonable rules and regulations, provided that Tenant receives a copy in writing of any new and/or modified rules and regulations. Tenant shall not do or permit anything to be done in or about the Premises which will in any way damage the reputation of the Project or unreasonably obstruct or interfere with the rights of other tenants or occupants of the Building and/or Project, or injure or annoy them or use or allow the Premises to be used for any improper, unlawful or objectionable purpose, nor shall Tenant cause, maintain or permit any nuisance in, on or about the Premises. Tenant shall comply with, and Tenant's rights and obligations under the Lease and Tenant's use of the Premises shall be subject and subordinate to, all recorded easements, covenants, conditions, and restrictions now or hereafter affecting the Project, provided that, with respect to any future and/or modified recorded easements, covenants, conditions, and restrictions affecting the Project after the date of this Lease, Landlord shall not voluntarily
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  • enter into any of the same to the extent that the same would materially interfere with Tenant's access to or use of the Premises for the Permitted Use. Further, notwithstanding anything contained herein to the contrary, in all events, Tenant’s use of the Premises, along with Tenant’s alterations to the Premises (including, without limitation, the Alterations and the Tenant Improvements), shall conform with, and shall not exceed, the Building Systems capacities available to the Premises as described on Exhibit F attached hereto.
  • Hazardous Materials.
  • Tenant's Obligations.
  • Prohibitions. As a material inducement to Landlord to enter into this Lease with Tenant, Tenant has fully and accurately completed Landlord's Pre-Leasing Environmental Exposure Questionnaire (the "Environmental Questionnaire"), which is attached as Exhibit E. Tenant agrees that except for those chemicals or materials, and their respective quantities, specifically listed on the Environmental Questionnaire (as may be updated from time to time in accordance with this Section 5.3), neither Tenant nor Tenant's employees, contractors and subcontractors of any tier, entities with a contractual relationship with Tenant (other than Landlord), or any entity acting as an agent or sub-agent of Tenant (collectively, "Tenant's Agents") will produce, use, store or generate any "Hazardous Materials," as that term is defined below, on, under or about the Premises, nor cause or permit any Hazardous Material to be brought upon, placed, stored, manufactured, generated, blended, handled, recycled, used or "Released," as that term is defined below, on, in, under or about the Premises. If any information provided to Landlord by Tenant on the Environmental Questionnaire, or otherwise relating to information concerning Hazardous Materials is false, incomplete, or misleading in any material respect, the same shall be deemed an Event of Default by Tenant under this Lease. Landlord's prior written consent shall be required to any Hazardous Materials use for the Premises not described on the initial Environmental Questionnaire, such consent to be withheld in Landlord's sole yet reasonable discretion. Tenant shall not install or permit any underground storage tank on the Premises. For purposes of this Lease, "Hazardous Materials" means all flammable explosives, petroleum and petroleum products, waste oil, radon, radioactive materials, toxic pollutants, asbestos, polychlorinated biphenyls ("PCBs"), medical waste, chemicals known to cause cancer or reproductive toxicity, pollutants, contaminants, hazardous wastes, toxic substances or related materials, including without limitation any chemical, element, compound, mixture, solution, substance, object, waste or any combination thereof, which is or may be hazardous to human health, safety or to the environment due to its radioactivity, ignitability, corrosiveness, reactivity, explosiveness, toxicity, carcinogenicity, infectiousness or other harmful or potentially harmful properties or effects, or defined as, regulated as or included in, the definition of "hazardous substances," "hazardous wastes," "hazardous materials," or "toxic substances" under any Environmental Laws. The term "Hazardous Materials" for purposes of this Lease shall also include any mold, fungus or spores, whether or not the same is defined, listed, or otherwise classified as a "hazardous material" under any Environmental Laws, if such mold, fungus or spores may pose a risk to human health or the environment . For purposes of this Lease, "Release" or "Released" or "Releases" shall mean any release, deposit, discharge, emission, leaking, spilling, seeping, migrating, injecting, pumping, pouring, emptying, escaping, dumping, disposing, or other movement of Hazardous Materials into the environment. Notwithstanding the foregoing, Landlord recognizes and acknowledges that Tenant or its agents may use and store within the Premises reasonable quantities of customary office and cleaning supplies; provided such items are stored, used and disposed of in accordance with applicable federal, state or local law.
  • Notices to Landlord. Tenant shall notify Landlord in writing as soon as possible but in no event later than five (5) days after (i) Tenant becomes aware of the occurrence of any actual, alleged or threatened Release of any Hazardous Material in, on, under, from, about or in the vicinity of the Premises (whether past or present), regardless of the source or quantity of any such Release, though if the Release of such Hazardous Material predated the Tenant's occupancy of the Premises, Tenant shall promptly notify Landlord of the same in writing upon discovery of the existence of such Release, or (ii) Tenant becomes aware of any regulatory actions, inquiries, inspections, investigations, directives, or any cleanup, compliance, enforcement or abatement proceedings (including any threatened or contemplated investigations or proceedings) relating to or potentially affecting the Premises, or (iii) Tenant becomes aware of any claims by any person or entity relating to any Hazardous Materials in, on, under, from, about or in the vicinity of the Premises, whether relating to damage, contribution, cost recovery, compensation, loss or injury. Collectively, the matters set forth in clauses (i), (ii) and (iii) above are hereinafter referred to as "Hazardous Materials Claims." Tenant shall promptly forward to Landlord copies of all orders, notices, permits, applications and other communications and reports in connection with any Hazardous Materials
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  • Claims. Additionally, Tenant shall promptly advise Landlord in writing of Tenant's discovery of any occurrence or condition on, in, under or about the Premises that could subject Tenant or Landlord to any liability, or restrictions on ownership, occupancy, transferability or use of the Premises under any "Environmental Laws," as that term is defined below. Tenant shall not enter into any legal proceeding or other action, settlement, consent decree or other compromise with respect to any Hazardous Materials Claims without first notifying Landlord of Tenant's intention to do so and affording Landlord the opportunity to join and participate, as a party if Landlord so elects, in such proceedings and in no event shall Tenant enter into any agreements which are binding on Landlord or the Premises without Landlord's prior written consent. Landlord shall have the right to appear at and participate in, any and all legal or other administrative proceedings concerning any Hazardous Materials Claim. For purposes of this Lease, "Environmental Laws" means all applicable present and future laws relating to the protection of human health, safety, wildlife or the environment, including, without limitation, (i) all requirements pertaining to reporting, licensing, permitting, investigation and/or remediation of emissions, discharges, Releases, or threatened Releases of Hazardous Materials, whether solid, liquid, or gaseous in nature, into the air, surface water, groundwater, or land, or relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport, or handling of Hazardous Materials; and (ii) all requirements pertaining to the health and safety of employees or the public. Environmental Laws include, but are not limited to, the Comprehensive Environmental Response, Compensation and Liability Act of 1980, 42 USC § 9601, et seq., the Hazardous Materials Transportation Authorization Act of 1994, 49 USC § 5101, et seq., the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act of 1976, and Hazardous and Solid Waste Amendments of 1984, 42 USC § 6901, et seq., the Federal Water Pollution Control Act, as amended by the Clean Water Act of 1977, 33 USC § 1251, et seq., the Clean Air Act of 1966, 42 USC § 7401, et seq., the Toxic Substances Control Act of 1976, 15 USC § 2601, et seq., the Safe Drinking Water Act of 1974, 42 USC §§ 300f through 300j, the Occupational Safety and Health Act of 1970, as amended, 29 USC § 651 et seq., the Oil Pollution Act of 1990, 33 USC § 2701 et seq., the Emergency Planning and Community Right-To-Know Act of 1986, 42 USC § 11001 et seq., the National Environmental Policy Act of 1969, 42 USC § 4321 et seq., the Federal Insecticide, Fungicide and Rodenticide Act of 1947, 7 USC § 136 et seq., California Carpenter-Presley-Tanner Hazardous Substance Account Act, California Health & Safety Code §§ 25300 et seq., Hazardous Materials Release Response Plans and Inventory Act, California Health & Safety Code, §§ 25500 et seq., Underground Storage of Hazardous Substances provisions, California Health & Safety Code, §§ 25280 et seq., California Hazardous Waste Control Law, California Health & Safety Code, §§ 25100 et seq., and any other state or local law counterparts, as amended, as such Applicable Laws, are in effect as of the Lease Commencement Date, or thereafter adopted, published, or promulgated.
  • Releases of Hazardous Materials. If any Release of any Hazardous Material in, on, under, from or about the Premises shall occur at any time during the Lease by Tenant or Tenant's Agents and/or if any other Hazardous Material condition exists at the Premises that requires response actions of any kind, in addition to notifying Landlord as specified above, Tenant, at its own sole cost and expense, shall (i) immediately comply with any and all reporting requirements imposed pursuant to any and all Environmental Laws, (ii) provide a written certification to Landlord indicating that Tenant has complied with all applicable reporting requirements, (iii) take any and all necessary investigation, corrective and remedial action in accordance with any and all applicable Environmental Laws, utilizing an environmental consultant approved by Landlord, all in accordance with the provisions and requirements of this Section 5.3, including, without limitation, Section 5.3.4, and (iv) take any such additional investigative, remedial and corrective actions as Landlord shall in its reasonable discretion deem necessary such that the Premises are remediated to the condition existing prior to such Release. Tenant shall not be responsible for fulfilling the requirements of this Section 5.3.1.3 for any Release of Hazardous Material (i) predating the Lease Commencement Date, or (ii) caused by Landlord or by another occupant of the Building or Project (so long as such occupant is not Tenant’s Agent).
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  • Indemnification.
  • In General. Without limiting in any way Tenant's obligations under any other provision of this Lease, Tenant shall be solely responsible for and shall protect, defend, indemnify and hold the Landlord Parties harmless from and against any and all Losses (including, without limitation, penalties, enforcement actions, fines, remedial actions, litigation, arbitration and administrative proceeding costs, expert and consultant fees and laboratory costs) including, without limitation, sums paid in settlement of Hazardous Materials Claims, which arise during or after the Lease Term, whether foreseeable or unforeseeable, that arise during or after the Lease Term in whole or in part, foreseeable or unforeseeable, directly or indirectly arising out of or attributable to the presence, use, generation, manufacture, treatment, handling, refining, production, processing, storage, Release or presence of Hazardous Materials in, on, under or about the Premises by Tenant or Tenant's Agents. Landlord shall indemnify, defend, protect and hold harmless Tenant from and against, all third party losses, costs, claims, liabilities and damages (including reasonable attorneys’ and consultants’ fees) arising out of any Hazardous Material Released by Landlord, its agents, contractors, or employees.
  • Limitations. Notwithstanding anything in Section 5.3.1.4, above, to the contrary, Tenant's indemnity of Landlord as set forth in Section 5.3.1.4, above, shall not be applicable to claims based upon Hazardous Materials which may exist in, on or about the Premises as of the Effective Date or that migrate to the Premises from adjacent property not due to acts of Tenant or any Tenant’s Agents ("Existing Hazardous Materials"), except to the extent that Tenant's construction activities and/or Tenant's (or any Tenant’s Agents’) other acts or omissions caused or exacerbated the subject claim.
  • Compliance with Environmental Laws. Without limiting the generality of Tenant's obligation to comply with Applicable Laws as otherwise provided in this Lease, Tenant shall, at its sole cost and expense, comply with all Environmental Laws. Tenant shall obtain and maintain any and all necessary permits, licenses, certifications and approvals appropriate or required for the use, handling, storage, and disposal of any Hazardous Materials used, stored, generated, transported, handled, blended, or recycled by Tenant on the Premises. Landlord shall have a continuing right, without obligation, to require Tenant to obtain, and to review and inspect any and all such permits, licenses, certifications and approvals, together with copies of any and all Hazardous Materials management plans and programs, any and all Hazardous Materials risk management and pollution prevention programs, and any and all Hazardous Materials emergency response and employee training programs respecting Tenant's use of Hazardous Materials. Upon request of Landlord, Tenant shall deliver to Landlord a narrative description explaining the nature and scope of Tenant's activities involving Hazardous Materials and showing to Landlord's reasonable satisfaction compliance with all Environmental Laws and the terms of this Lease. Landlord represents and warrants that, to its actual knowledge, it has not received any written notice of violation of Environmental Laws from the applicable governmental authority regarding any use, storage, treatment or transportation of Hazardous Materials in, on or about the Project, Building or Premises prior to the Effective Date of this Lease. For purposes of this Section 5.3.1.5, whenever phrases such as "to Landlord's knowledge" or "its actual knowledge" or similar phrases are used in the foregoing representations and warranties, they will be deemed to refer exclusively to matters within the current actual (as opposed to constructive) knowledge of Michael Dorris (the "Landlord's Representative"). No duty of inquiry or investigation on the part of Landlord or Landlord's Representative will be required or implied by the making of any representation or warranty which is so limited to matters within Landlord's actual knowledge, and in no event shall Landlord's Representative have any personal liability therefor.
  • Assurance of Performance.
  • Environmental Assessments In General. Landlord may, but shall not be required to, engage from time to time such contractors as Landlord determines to be appropriate to perform environmental assessments of a scope reasonably determined by Landlord (an "Environmental Assessment") to ensure Tenant's compliance with the requirements of this Lease with respect to Hazardous Materials. Except to the extent required in the cause of emergencies with imminent threat of serious harm to person or properties, Landlord shall give Tenant at least five (5) business days prior written notice of any such Environmental Assessments.
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  • Costs of Environmental Assessments. All costs and expenses incurred by Landlord in connection with any such Environmental Assessment initially shall be paid by Landlord; provided that if any such Environmental Assessment shows that Tenant has failed to comply with the provisions of this Section 5.3, then all of the costs and expenses of such Environmental Assessment shall be reimbursed by Tenant as Additional Rent within thirty (30) days after receipt of written demand therefor, together with reasonable supporting documentation of such costs.
  • Tenant's Obligations upon Surrender. At the expiration or earlier termination of the Lease Term, Tenant, at Tenant's sole cost and expense, shall: (i) cause an Environmental Assessment of the Premises to be conducted in accordance with Section 15.3; (ii) cause all Hazardous Materials to be removed from the Premises and disposed of in accordance with all Environmental Laws and as necessary to allow the Premises to be used for the same uses of the Premises as are allowed as of the Lease Commencement Date; and (iii) cause to be removed all containers installed or used by Tenant or Tenant's Agents to store any Hazardous Materials on the Premises, and cause to be repaired any damage to the Premises caused by such removal.
  • Clean-up.
  • Environmental Reports; Clean-Up. If any written report, including any report containing results of any Environmental Assessment (an "Environmental Report") shall indicate (i) the presence of any Hazardous Materials as to which Tenant has a removal or remediation obligation under this Section 5.3, and (ii) that as a result of same, the investigation, characterization, monitoring, assessment, repair, closure, remediation, removal, or other clean-up (the "Clean-up") of any Hazardous Materials is required, Tenant shall promptly prepare and submit to Landlord within thirty (30) days after receipt of the Environmental Report a comprehensive plan, subject to Landlord's written approval (not to be unreasonably withheld, conditioned, or delayed), specifying the actions to be taken by Tenant to perform the Clean-up so that the Premises are restored to the conditions required by this Lease. Upon Landlord's approval of the Clean-up plan, Tenant shall, at Tenant's sole cost and expense, without limitation on any rights and remedies of Landlord under this Lease, promptly implement such plan with a consultant reasonably acceptable to Landlord and proceed to Clean-Up Hazardous Materials in accordance with all Applicable Laws and as required by such plan and this Lease. If, within thirty (30) days after receiving a copy of such Environmental Report, Tenant fails either (a) to complete such Clean-up, or (b) with respect to any Clean-up that cannot be completed within such thirty-day period, fails to proceed with diligence to prepare the Clean-up plan and complete the Clean-up as promptly as practicable, then Landlord shall have the right, but not the obligation, and without waiving any other rights under this Lease, to carry out any Clean-up recommended by the Environmental Report or required by any governmental authority having jurisdiction over the Premises, and recover all of the actual costs and expenses thereof from Tenant as Additional Rent, payable within thirty (30) days after receipt of written demand therefor, together with reasonable supporting documentation of such costs.
  • No Rent Abatement. Tenant shall continue to pay all Rent due or accruing under this Lease during any Clean-up necessitated by the acts or omissions of Tenant or any Tenant’s Agents in violation of the terms of this Article 5, and shall not be entitled to any reduction, offset or deferral of any Base Rent or Additional Rent due or accruing under this Lease during any such Clean-up.
  • Surrender of Premises. Tenant shall complete any Clean-up prior to surrender of the Premises upon the expiration or earlier termination of this Lease. If applicable, Tenant shall obtain and deliver to Landlord a letter or other written determination from the overseeing governmental authority confirming that the Clean-up has been completed in accordance with all requirements of such governmental authority and that no further response action of any kind is required for the unrestricted use of the Premises ("Closure Letter"), unless such governmental authority's standard practices at the relevant time do not provide for such Closure Letter. Upon the expiration or earlier termination of this Lease, Tenant shall also be obligated to close all permits obtained in connection with Hazardous Materials in accordance with Applicable Laws.
  • Failure to Timely Clean-Up. Should any Clean-up for which Tenant is responsible not be completed, or should Tenant not receive the Closure Letter and any governmental approvals required under Environmental Laws in conjunction with such Clean-up prior to the expiration or earlier termination of this Lease (if required and unless such governmental authority's standard practices at the relevant time do not provide for such Closure Letter), and Tenant's failure to receive the Closure Letter is prohibiting Landlord from leasing
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  • the Premises to a third party, or prevents the occupancy or use of the Premises by a third party, then Tenant shall be liable to Landlord as a holdover tenant (as more particularly provided in Article 16) until Tenant has fully complied with its obligations under this Section 5.3.
  • Confidentiality. Unless compelled to do so by Applicable Law, Tenant agrees that Tenant shall not disclose, discuss, disseminate or copy any information, data, findings, communications, conclusions and reports regarding the environmental condition of the Premises to any Person (other than Tenant's consultants, attorneys, property managers and employees that have a need to know such information), including any governmental authority, without the prior written consent of Landlord. In the event Tenant reasonably believes that disclosure is compelled by Applicable Law, it shall provide Landlord ten (10) days' advance notice (or such shorter times as may be necessary due to Applicable Laws) of disclosure of confidential information so that Landlord may attempt to obtain a protective order. Tenant may additionally release such information to bona fide prospective purchasers or lenders, subject to any such parties' written agreement to be bound by the terms of this Section 5.3.
  • Copies of Environmental Reports. Within thirty (30) days of receipt thereof, Tenant shall provide Landlord with a copy of any and all environmental assessments, audits, studies and reports in Tenant's possession or control regarding Tenant's activities with respect to the Premises, or ground water beneath the Land, or the environmental condition or Clean-up thereof. Tenant shall be obligated to provide Landlord with a copy of such materials without regard to whether such materials are generated by Tenant or prepared for Tenant, or how Tenant comes into possession of such materials, unless to do so would expose Tenant to a claim of breach of a nondisclosure obligation or be a violation of Applicable Laws.
  • Signs, Response Plans, Etc. Tenant shall be responsible for posting on the Premises any signs required under applicable Environmental Laws. Tenant shall also complete and file any business response plans or inventories required by any Applicable Laws. Tenant shall concurrently file a copy of any such business response plan or inventory with Landlord.
  • Landlord Obligation. If it is discovered that, through no fault of Tenant or any of Tenant's Agents, any Hazardous Materials exist in the Premises as of the Possession Date which (i) are in violation of applicable Environmental Laws in effect as of such date and (ii) would prohibit Tenant from obtaining or maintaining a certificate of occupancy for the Premises, or would unreasonably and materially affect the safety of Tenant's employees or create a significant health hazard for Tenant's employees, or would otherwise materially and adversely affect Tenant's use of or access to the Premises, Landlord shall take all necessary steps to remediate the Hazardous Materials as required by and in compliance with applicable Environmental Laws, all at Landlord's cost which shall not be included in Operating Expenses; provided, however, Tenant shall, at its cost, be responsible for such remediation as and to the extent (A) Tenant or any of Tenant's Agents introduced the Hazardous Materials or exacerbated an existing Hazardous Materials problem, and/or (B) such remediation pertains to Hazardous Materials located within any components of the Premises that are Tenant's repair obligations under Section 7.1 below (but not any components that are Landlord repair obligations under Section 7.4 below and not any Existing Hazardous Materials) and is required to comply with Environmental Laws first enacted or amended after the Possession Date.
  • Survival. Each covenant, agreement, representation, warranty and indemnification made by Tenant set forth in this Section 5.3 shall survive the expiration or earlier termination of this Lease and shall remain effective until all of Tenant's obligations under this Section 5.3 have been completely performed and satisfied.
  • SERVICES AND UTILITIES
  • In General. Landlord shall provide the following services on all days (unless otherwise stated below) during the Lease Term.
  • Subject to limitations imposed by all governmental rules, regulations and guidelines applicable thereto, Landlord shall provide heating, ventilation and air conditioning to the office portions of the Premises ("HVAC") when necessary for normal comfort for normal office use in the Premises 24 hours per day, 7 days per week. HVAC to the lab portion of the Premises will also be provided 24 hours per day, 7 days per week. Tenant shall cooperate fully with Landlord at all times and abide by all commercially reasonable regulations and
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  • requirements that Landlord may reasonably prescribe for the proper functioning and protection of the HVAC, electrical, mechanical and plumbing systems.
  • Landlord shall provide reasonably sufficient electricity to the Premises (including adequate electrical wiring and facilities for connection to Tenant's lighting fixtures and incidental use equipment), provided that the connected electrical load of Tenant's lighting fixtures and the incidental use equipment does not, in the aggregate, exceed the connected electrical loads typically required at First Class Life Sciences Projects. Tenant will design Tenant's electrical system serving any equipment producing nonlinear electrical loads to accommodate such nonlinear electrical loads, including, but not limited to, oversizing neutral conductors, derating transformers and/or providing power-line filters. Engineering plans shall include a calculation of Tenant's fully connected electrical design load with and without demand factors and shall indicate the number of watts of unmetered and submetered loads. Tenant shall bear the cost of replacement of lamps, starters and ballasts for non-Building standard lighting fixtures within the Premises. Landlord, at its sole cost, shall install submetering equipment for Tenant’s electric usage in the Premises, and Tenant shall pay to Landlord the cost of such utilities based on such sub-meter, and reimbursement for any penalties for usage or other surcharges imposed by any utility company. Within thirty (30) days after receipt of Landlord's statement of apportionment or statement setting forth the charges payable by Tenant, Tenant shall pay to Landlord, as Additional Rent (and not as a Direct Expense), the cost of such electrical services so apportioned or so provided by Landlord. Notwithstanding anything to the contrary set forth herein, to the extent the Premises generates electricity demand on a shared resource (e.g. electricity for the shared heating, ventilation and air-conditioning system serving the Building), the cost of such electricity shall be allocated to Tenant in an equitable manner or other reasonable basis consistent with commercially reasonable property management practices.
  • Landlord shall provide city water from the regular Building outlets for drinking, kitchen, lavatory and toilet purposes in the Building Common Areas and the Premises.
  • Landlord shall provide nonexclusive, non-attended automatic passenger elevator service during the Building Hours, i.e., from 7:00 A.M. to 6:00 P.M. Monday through Friday (collectively, the "Building Hours"), except for the date of observation of New Year's Day, President's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, Christmas Day and, at Landlord's discretion, other locally or nationally recognized holidays (collectively, the "Holidays"), and shall have one elevator available at all other times, including on the Holidays, except in the event of emergency.
  • Landlord shall not provide janitorial services for the Premises. Tenant shall be solely responsible for performing all janitorial services and other cleaning of the Premises, all in compliance with Applicable Laws. The janitorial and cleaning of the Premises shall be adequate to maintain the Premises in a manner consistent with First Class Life Sciences Projects.
  • Landlord shall provide janitorial services for the Common Areas in a manner consistent with First Class Life Sciences Projects.
  • If Tenant desires to use HVAC during hours other than those for which Landlord is obligated to supply such utilities pursuant to the terms of Section 6.1.1 of this Lease, Tenant shall give Landlord such prior notice, if any, as Landlord shall from time to time reasonably establish as appropriate, of Tenant's desired use in order to supply such HVAC, and Landlord shall supply such heat, ventilation or air conditioning to Tenant at such hourly cost to Tenant as Landlord shall reasonably determine for the Building.
  • Interruption of Use. Tenant agrees that Landlord shall not be liable for damages, by abatement of Rent or otherwise, for failure to furnish or delay in furnishing any service (including telephone and telecommunication services), or for any diminution in the quality or quantity thereof, (including, without limitation, where any such failure, delay or diminution is occasioned, in whole or in part, by breakage, repairs, replacements, or improvements, by any strike, lockout or other labor trouble, by inability to secure electricity, gas, water, or other fuel at the Building or Project after reasonable effort to do so, by any riot or other dangerous condition, emergency, accident or Casualty (as that term is defined in Section 11.1 below) whatsoever, by act or default of Tenant or other parties, or by any other cause); and such failures, delays or diminution shall never be deemed to constitute an eviction or disturbance of Tenant's use and possession of the Premises or relieve Tenant from paying Rent or performing any of its obligations under this Lease. Furthermore, Landlord shall not be liable under any circumstances for a loss of, or injury to, property
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  • or for injury to, or interference with, Tenant's business, including, without limitation, loss of profits, however occurring, through or in connection with or incidental to a failure to furnish any of the services or utilities as set forth in this Article 6.
  • Utility Information. Tenant hereby acknowledges and agrees that (i) pursuant to certain applicable laws and/or sustainability reporting requirements (collectively the "Energy Disclosure Requirements"), Landlord may be required to disclose factual information concerning Tenant's energy usage at the Project to certain third parties, including, without limitation, prospective purchasers, lenders and tenants of the Building and/or Landlord's consultants and/or vendors (the "Tenant Energy Use Disclosure"), and (ii) in connection therewith, to the extent any utilities are separately metered and paid by Tenant, Tenant shall reasonably cooperate with Landlord as necessary to submit energy and water consumption data, including total usage and total charges as they appear on Tenant's electric, gas, water, and other utility bills, in a format deemed reasonably acceptable by Landlord, provided Tenant shall have no responsibility for additional costs for such cooperation other than to a de minimis administrative extent. Tenant hereby further (A) consents to all such Tenant Energy Use Disclosures made by Landlord, (B) acknowledges that Landlord shall not be required to notify Tenant of any Tenant Energy Use Disclosure, and (C) releases Landlord from any and all losses, costs, damages, expenses and liabilities relating to, arising out of and/or resulting from any Tenant Energy Use Disclosure made in accordance with the foregoing provisions. The terms of this Section 6.3 shall survive the expiration or earlier termination of this Lease.
  • Access. Subject to compliance with Landlord's commercially reasonable access control procedures and Applicable Laws, and except when and where Tenant's right of access is specifically restricted or limited in this Lease, Tenant shall have the right of access to the Premises twenty-four (24) hours per day, seven (7) days per week, every day of the year during the Lease Term.
  • Tenant's Emergency Generator. Landlord and Tenant hereby acknowledge that there is an existing generator currently serving the Building and Premises ("Emergency Generator") of approximately 750kW, and Tenant shall have the right, at no additional cost (other than as included in Operating Expenses), to connect to the Emergency Generator for up to Tenant's Share of the electrical capacity provided by such Emergency Generator during the Lease Term, as extended by the Option Term as applicable. Tenant's use of the Emergency Generator shall be at Tenant's sole risk, and Tenant acknowledges that neither Landlord nor any agent of Landlord has made any representation or warranty regarding the Emergency Generator. Except to the extent caused by the gross negligence or willful misconduct of Landlord, or any Landlord Parties, Tenant hereby waives any claims against Landlord or any Landlord Parties resulting from Tenant's use of the Emergency Generator, or any failure of the Emergency Generator to operate as designed, and agrees that Landlord shall not be liable for any damages resulting from any failure in operation of the Emergency Generator, including, without limitation any injury or damage to, or interference with, Tenant's business, including but not limited to, loss of profits, loss of rents or other revenues, loss of business opportunity, loss of goodwill or loss of use, or loss to equipment, inventory, scientific research, scientific experiments, laboratory animals, products, specimens, samples, and/or scientific, business, accounting and other records of every kind and description kept at the Premises and any and all income derived or derivable therefrom. Tenant acknowledges that Operating Expenses shall include Landlord's costs incurred in maintaining and operating the Emergency Generator (including all permit costs and fees).
  • REPAIRS
  • Tenant Repair Obligations. Subject to Landlord’s obligations set forth in Section 7.2 below, Tenant shall, at Tenant's own expense, keep the Premises, including all improvements, fixtures and furnishings therein, and the floor or floors of the Building on which the Premises are located, in good order, repair and condition at all times during the Lease Term. In addition, Tenant shall, at Tenant's own expense, but under the supervision and subject to the prior approval of Landlord (not to be unreasonably withheld, conditioned, or delayed), and within any reasonable period of time specified by Landlord, promptly and adequately repair all damage to the Premises and replace or repair all damaged, broken, or worn fixtures and appurtenances, except for damage caused by ordinary wear and tear or beyond the reasonable control of Tenant; provided however, that, Landlord shall have the exclusive right, at Landlord's option, but not the obligation, to make such repairs and replacements, and Tenant shall pay to Landlord the actual cost thereof, including Landlord's commercially reasonable standard fee for its involvement with such repairs and replacements (to be uniformly established for the Building at a commercially reasonable level), within thirty (30) days upon being billed for same (such fee not to exceed the greater of 3% of hard costs or Landlord’s Building-standard
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  • fee). Landlord may, but shall not be required to, enter the Premises, pursuant to the terms of Article 27, below, to make such repairs, alterations, improvements or additions to the Premises or to the Project or to any equipment located in the Project as Landlord shall desire or deem necessary or as Landlord may be required to do by governmental or quasi-governmental authority or court order or decree. Tenant hereby waives any and all rights under and benefits of subsection 1 of Section 1932 and Sections 1941 and 1942 of the California Civil Code or under any similar law, statute, or ordinance now or hereafter in effect.
  • Landlord Repair Obligations. Notwithstanding the foregoing, Landlord shall be responsible for repairs and replacement as necessary to the exterior walls, exterior doors and windows and waterproofing of the Building envelope, foundation and roof (including roof membrane, gutters, flashings, and downspouts) of the Building, utility connections to the Building, the structural portions of the floors of the Building, including but not limited to the slab, and other structural portions of the Building (even if located within the Premises) (the "Building Structure"), the base Building plumbing, sewer, drainage, electrical, fire protection, elevator, life safety, heating, ventilation and air-conditioning systems (the "Building Systems" and together with the Building Structure, the "Base Building") of the Building, and the Common Areas, except to the extent that such repairs are required due to the negligence or willful misconduct of Tenant; provided, however, that if such repairs are due to the negligence or willful misconduct of Tenant, Landlord shall nevertheless make such repairs at Tenant's expense, or, if covered by Landlord's insurance, Tenant shall only be obligated to pay any deductible in connection therewith. Subject to the terms of Article 27, below, Landlord may, but shall not be required to, enter the Premises at all reasonable times and upon reasonable prior notice to make such repairs, alterations, improvements or additions to the Premises or to the Project or to any equipment located in the Project as Landlord shall desire or deem necessary or as Landlord may be required to do by governmental or quasi-governmental authority or court order or decree. Tenant hereby waives any and all rights under and benefits of subsection 1 of Section 1932 and Sections 1941 and 1942 of the California Civil Code or under any similar law, statute, or ordinance now or hereafter in effect.
  • ADDITIONS AND ALTERATIONS
  • Landlord's Consent to Alterations. Except for the initial Tenant Improvements expressly described in the Tenant Work Letter attached hereto, Tenant may not make any repairs, improvements, alterations, additions or changes to the Premises or other portion of the Project, or any mechanical, plumbing or HVAC facilities or systems pertaining to the Premises or Project (collectively, the "Alterations") without the prior written consent of Landlord to such Alterations, which consent shall be requested by Tenant not less than twenty (20) days prior to the commencement thereof, and which consent shall not be unreasonably withheld, conditioned, or delayed by Landlord, provided it shall be deemed reasonable for Landlord to withhold its consent to any Alteration which may (a) affect the exterior appearance of the Building; (b) affect the Building structure or adversely affect the Building Systems; (c) fail to comply with Applicable Laws or cause any other portion of the Project to fail to comply with Applicable Laws; (d) be in material conflict with Landlord's Sustainability Initiative (including, without limitation, by jeopardizing any Green Certification); (e) vitiate or otherwise negatively affect any warranty, guaranty, or insurance maintained by Landlord; (f) materially increase Landlord's Repair Obligations; (g) obstructs or interferes with other tenants or occupants of the Project, or (h) be unusually difficult or expensive to remove or not be readily usable for a future tenant. Notwithstanding the foregoing, Tenant shall be permitted to make Alterations following ten (10) business days' notice to Landlord, but without Landlord's prior consent, to the extent that such Alterations (i) do not affect the Building Systems or any Building equipment, (ii) are not visible from the exterior of the Building, (iii) cost less than $200,000.00 for a particular job of work, and (iv) do not adversely affect the value of the Premises, Building, and/or Project ("Cosmetic Alterations"). The construction of the initial improvements to the Premises shall be governed by the terms of the Tenant Work Letter and not the terms of this Article 8 (provided, however, that such initial improvements shall be deemed to constitute Alterations for purposes of Sections 8.5 and 15.2 below).
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  • Manner of Construction. Landlord may impose, as a condition to Tenant's right to perform any Alterations, other than the initial Tenant Improvements described in the Tenant Work Letter, such requirements as Landlord in its reasonable discretion may deem desirable, including, but not limited to, the requirement that (i) upon Landlord's request (which request shall be made at the time of approval of such Alteration subject to the terms of Section 8.5 below), Tenant shall, at Tenant's expense, remove such Alterations upon the expiration or any early termination of the Lease Term, (ii) Tenant utilize for such purposes only contractors reasonably approved by Landlord, (iii) Tenant enter into a construction contract that includes Landlord's then-standard commercially reasonable construction rider (or such other construction rider as Landlord may reasonably require), which rider shall include, among other things, Landlord's commercially reasonable insurance and indemnity requirements, and (iv) any "Lines" (as that term is defined in Section 22 below), including riser cables, installed by Tenant shall be (x) appropriately insulated to prevent excessive electromagnetic fields or radiation, (y) surrounded by a protective conduit reasonably acceptable to Landlord, and (z) identified in accordance with Landlord's Building standard requirements. Tenant shall be solely responsible for acquiring any required permit for all Alterations, furnishing of a copy of such permit and approvals to Landlord prior to the commencement of the work, and complying with all conditions of said permit in a prompt and expeditious manner. If such Alterations will involve the use of or disturb Hazardous Materials, Tenant shall notify Landlord prior to performing such Alterations and comply with Landlord's commercially reasonable, non-discriminatory rules and regulations concerning such Hazardous Materials. Tenant shall construct such Alterations and perform such repairs in a good and workmanlike manner, in conformance with any and all Applicable Laws. Tenant shall not use (and upon notice from Landlord shall cease using) contractors, services, workmen, labor, materials or equipment that, in Landlord's reasonable judgment, would disturb labor harmony with the workforce or trades engaged in performing other work, labor or services in or about the Project. In addition to Tenant's obligations under Article 9 of this Lease, upon completion of any Alterations, Tenant shall cause a Notice of Completion to be recorded in the office of the Recorder of the county in which the Project is located in accordance with Section 8182 of the Civil Code of the State of California or any successor statute. Tenant shall, promptly following the completion of any Alterations (including any Cosmetic Alterations), compile and deliver to Landlord a "close-out package" in such format designated by Landlord (e.g., paper and/or electronic files) containing, without limitation, the following items (to the extent deemed necessary by Landlord for the particular Alterations): (a) as-built drawings and final record CAD drawings, if applicable, (b) warranties and guarantees from all contractors, subcontractors and material suppliers, (c) all permits, approvals and other documents issued by any governmental agency in connection with the Alterations, if applicable, (d) an independent air balance report, if reasonably required due to the nature of the Alterations, (e) lien releases for all work performed at the Project, and (f) such other reasonable information or materials as may be reasonably requested by Landlord.
  • Payment for Improvements. Tenant is responsible for all of the costs in performance of any Alterations. In addition, in connection with all Alterations other than (i) the initial Tenant Improvements described in the Tenant Work Letter and (ii) Cosmetic Alterations, Tenant shall pay to Landlord an oversight fee equal to three percent (3%) of the hard construction costs of the Alterations. Tenant shall also reimburse Landlord for Landlord's reasonable, out-of-pocket costs and expenses actually incurred in connection with Landlord's review of such Alterations (including, but not limited to, fees paid to consultants retained by Landlord to review plans and specifications for such Alterations).
  • Construction Insurance. In addition to the requirements of Article 10 of this Lease, in the event that Tenant makes any Alterations, prior to the commencement of such Alterations, Tenant shall provide Landlord with evidence that Tenant carries "Builder's Risk" insurance in an amount reasonably approved by Landlord covering the construction of such Alterations, and such other commercially reasonable insurance as Landlord may reasonably require, it being understood and agreed that all of such Alterations shall be insured by Tenant pursuant to Article 10 of this Lease immediately upon completion thereof. In addition, Tenant's contractors and subcontractors shall be required to carry (i) Commercial General Liability Insurance in an amount reasonably approved by Landlord, with Landlord, and, at Landlord's option, Landlord's property manager and project manager, as additional insureds in an amount reasonably approved by Landlord, and otherwise in accordance with the requirements of Article 10 of this Lease, and (ii) workers compensation insurance with a waiver of subrogation in favor of Landlord. Landlord may, in its reasonable discretion, require Tenant to obtain a lien and completion bond or some alternate form of security satisfactory to Landlord in an amount sufficient to ensure the lien-free completion of such Alterations and naming Landlord as a co-obligee if such Alterations are expected to cost in excess of $300,000 per Alteration.
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  • Landlord's Property. All Alterations, improvements, fixtures (other than Tenant's trade fixtures), equipment and/or appurtenances which may be installed or placed in or about the Premises, from time to time, shall be at the sole cost of Tenant and shall be and become the property of Landlord and remain in place at the Premises following the expiration or earlier termination of this Lease. Notwithstanding the foregoing, at Tenant's written request (provided such request was made simultaneously with Tenant’s request for Landlord’s consent to particular Alterations, Landlord shall, by written notice to Tenant (the "Removal Notice") given at the time Landlord approves such particular Alterations (or, with respect to any Alterations not requiring Landlord's consent, Landlord shall provide a Removal Notice within ten [10] business days of Tenant's written request for a determination [including all plans and specifications for such Alterations]) determine whether Tenant shall be required, at Tenant's expense, to remove any Alterations and/or improvements and/or systems and equipment installed by or on behalf of Tenant within the Premises and to repair any damage to the Premises and Building caused by such removal and return the affected portion of the Premises to a building standard tenant improved condition as determined by Landlord at the expiration or earlier termination of this Lease. If Tenant fails to provide such a written request to Landlord for Landlord’s determination as provided above, Landlord may, by written notice to Tenant prior to the end of the Lease Term, or given following any earlier termination of this Lease, require Tenant, at Tenant’s expense, to remove such Alterations and/or improvements and/or systems and equipment in the Premises and return the affected portion of the Premises to a building standard tenant improved condition as reasonably determined by Landlord. If Landlord fails to provide a Removal Notice, such failure shall not be deemed Landlord's waiver of its right to require removal of any Alterations and/or improvements and/or systems and equipment within the Premises, until Tenant first delivers to Landlord written notice specifying in all capital letters and boldface type (minimum 16 point font) on page one of such notice the following: "YOUR FAILURE TO ELECT REMOVAL OF THE APPROVED ALTERATION AND/OR THE ALTERATION NOT REQUIRING LANDLORD'S CONSENT AS FURTHER DESCRIBED IN THIS NOTICE WITHIN FIVE (5) BUSINESS DAYS OF RECEIPT OF THIS NOTICE SHALL BE DEEMED YOUR ELECTION TO NOT REQUIRE REMOVAL OF SUCH ALTERATION," and provided Landlord fails to make an election within such five (5) business day period then Tenant shall have no obligation or responsibility to remove such Alterations upon the expiration or earlier termination of this Lease. If Tenant fails to complete such removal and/or to repair any damage caused by the removal of any Alterations and/or improvements and/or systems and equipment in the Premises and return the affected portion of the Premises to a building standard tenant improved condition as reasonably determined by Landlord, Landlord may do so and may charge the cost thereof to Tenant.
  • Intentionally Deleted.
  • Rooftop Equipment. Tenant shall, subject to the terms of this Article 8, have the non-exclusive right, at Tenant's sole cost and expense, to install satellite and related communication equipment, chillers and/or supplemental HVAC equipment upon the roof of the Building without any representation or warranty by Landlord as to the condition of the same (collectively, the "Rooftop Equipment") under the following conditions: (i) all plans and specifications for the Rooftop Equipment, including but not limited to, weight, configuration, location, means of installation, cabling and screening of the Rooftop Equipment are subject to the prior reasonable approval of Landlord, not to be unreasonably conditioned or delayed; (ii) Tenant shall provide evidence to Landlord that Tenant has obtained all governmental approvals and permits required for the installation and operation of the Rooftop Equipment; (iii) Tenant shall provide evidence to Landlord of insurance coverage for the installation, location, repair, removal, and operation of the Rooftop Equipment, with Landlord as an additional insured, all in form and substance reasonably approved by Landlord and such insurance shall be maintained during the Lease Term; (iv) Tenant shall, in accordance with Article 10, indemnify, defend, and hold Landlord harmless from and against any and all loss, liability, cost and expense incurred by Landlord as a result of the installation, location, repair, removal, or operation of the Rooftop Equipment on the Building; (v) Tenant shall be responsible for the installation, engineering, maintenance, repair and removal of the Rooftop Equipment and appurtenant equipment in accordance with all federal, state and local laws, and ordinances; (vi) no roof penetrations shall be made without obtaining Landlord's consent, which consent may be withheld by Landlord in its sole discretion; (vii) Tenant shall be responsible for any impairment of Landlord's roof warranty as a result of installation of the Rooftop Equipment; (viii) Tenant shall, at its own expense, promptly repair any damage or wear to the roof resulting from the installation and use of the Rooftop Equipment and appurtenant equipment; and (x) the operation of the Rooftop Equipment shall be for Tenant's internal use only. Landlord shall grant Tenant access to the roof for such installation, maintenance, repair, and removal of the Rooftop Equipment. Any provider of satellite or communication systems for Tenant's use on the Premises must, prior to installing any system or providing any service, enter into a written agreement reasonably acceptable to Landlord setting forth the terms and conditions of the access to be granted to such provider confirming the terms of installation and operation of Rooftop
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  • Equipment consistent with this Section 8.7. Tenant shall pay directly to the provider all costs and expenses relating to the installation and use of the Rooftop Equipment, including, without limitation, any license or service fee charged by the provider. Upon the expiration or earlier termination of this Lease, Tenant shall promptly remove the Rooftop Equipment and appurtenant equipment and repair any damage caused by such removal.
  • Security System. Landlord and Tenant hereby acknowledge that Tenant shall be authorized, during the Lease Term, to install in the Premises an integrated security system ("Security System"). In connection therewith, Landlord and Tenant hereby agree that any such installation by Tenant shall be at Tenant's sole cost and expense and shall be in accordance with the terms and conditions of this Article 8. The details, plans, specifications and location for such Security System shall be subject to Landlord's prior written approval, not to be unreasonably withheld, conditioned, or delayed. Such Security System and/or the installation thereof must be compatible with the existing systems of the Project and must not adversely affect or interfere with the Project's structure and systems. Tenant shall maintain and operate any such Security System in accordance and compliance with this Lease and all Applicable Laws. Tenant's obligation to indemnify, defend and hold Landlord harmless as provided in, and subject to, Article 10 shall also apply to Tenant's use and operation of any such Security System. Landlord shall, in no event, be obligated to monitor or respond to such Security System. At Landlord's option, upon the expiration or earlier termination of this Lease, Tenant shall remove such Security System and repair any damage to the Premises resulting from such removal. If Landlord does not elect to have Tenant remove the Security System, such Security System shall become Landlord's property as provided for in Section 8.5 and remain on the Premises following the expiration or earlier termination of this Lease. Tenant shall at all times provide Landlord with a contact person who can disarm the Security System and who is familiar with the functions of the Security System in the event of a malfunction, and Tenant shall provide Landlord with the alarm codes or other necessary information required to disarm the Security System in the event Landlord must enter the Premises. Landlord and Tenant agree and acknowledge that nothing contained in this Section 8.8 shall be construed to limit the rights of Landlord under this Lease. Notwithstanding anything to the contrary contained herein, Landlord shall use commercially reasonable efforts to provide the following security features at the Project (collectively, the "Building Security Features"), the costs of which shall be included in Operating Expenses: (i) the security cameras for the Common Areas of the Project existing as of the date of execution and delivery of this Lease; and (ii) an on-site professional security guard for the Common Areas of the Project (who may intermittently roam/patrol the Common Areas of the Project) after normal business hours, with certain national holidays excepted (provided, that, if Landlord expands such security guard service for the Common Areas of the Project on a standardized basis [i.e., with respect to expanded hours and/or a posted guard], then the Building Security Features hereunder and Landlord's obligations with respect thereto shall be revised to the same). Although Landlord agrees to use commercially reasonable efforts to provide the Building Security Features set forth in the foregoing provisions of this Section 8.8, Landlord shall not be liable for, and Tenant hereby waives and releases Landlord from, any and all responsibility for any damage or injury either to person or property sustained by Tenant or any of any of its agents, contractors, employees, licensees and/or invitees in connection with or arising from the Building Security Features, including any acts or omissions of security personnel (including, without limitation, the admission to or exclusion from the Building or Project of any person) or Landlord's failure to provide such Building Security Features.
  • COVENANT AGAINST LIENS. Tenant shall keep the Project and Premises free from any liens or encumbrances arising out of the work performed, materials furnished or obligations incurred by or on behalf of Tenant, and shall protect, defend, indemnify and hold Landlord harmless from and against any "Losses" (as defined in Section 10.1 below) arising out of same or in connection therewith. Tenant shall give Landlord notice at least ten (10) business days prior to the commencement of any such work on the Premises (or such additional time as may be necessary under Applicable Laws) to afford Landlord the opportunity of posting and recording appropriate notices of non-responsibility (and Tenant shall, upon demand, reimburse Landlord for the costs and expenses incurred by Landlord in connection with preparing and recording any such notices of non-responsibility). Tenant shall remove any such lien or encumbrance by bond or otherwise within ten (10) business days after notice by Landlord, and if Tenant shall fail to do so, Landlord may pay the amount necessary to remove such lien or encumbrance, without being responsible for investigating the validity thereof. The amount so paid shall be deemed Additional Rent under this Lease payable to Landlord within ten (10) business days after Landlord's demand therefor (or, at Landlord's election, Landlord may deduct such amounts from any undisbursed improvement allowance or other allowance granted to Tenant under this Lease), without limitation as to other remedies available to Landlord under this Lease. Nothing contained in this Lease shall authorize Tenant to do any act which shall subject Landlord's title to the Building or Premises to any liens or encumbrances whether claimed by operation of law or express or implied contract. Any claim to a lien or encumbrance upon the Building or Premises arising in connection with any such work or respecting the Premises not
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  • performed by or at the request of Landlord shall be null and void, or at Landlord's option shall attach only against Tenant's interest in the Premises and shall in all respects be subordinate to Landlord's title to the Project, Building and Premises.
  • INSURANCE
  • Indemnification and Waiver. Except to the extent arising from the gross negligence or willful misconduct of Landlord or Landlord Parties, or Landlord's breach of the terms of this Lease beyond all applicable notice and cure periods, but subject to the waiver of subrogation requirements herein, Tenant hereby assumes all risk of damage to property or injury to persons in, upon or about the Premises from any cause whatsoever and agrees that Landlord, its partners, subpartners and their respective officers, agents, employees, lenders, any property manager and independent contractors (collectively, "Landlord Parties") shall not be liable for, and are hereby released from any responsibility for, any damage either to person or property or resulting from the loss of use thereof, which damage is sustained by Tenant or by other persons claiming through Tenant. Tenant shall indemnify, defend, protect, and hold harmless the Landlord Parties from and against any and all claims, losses, costs, damages, expenses, causes of action, proceedings, and liability (including without limitation court costs and reasonable attorneys' fees) (collectively, "Losses") incurred in connection with or arising from: (i) any causes in, on or about the Premises; (ii) any acts, omissions or negligence of Tenant or of any person claiming under Tenant, its Transferees, or the contractors, agents, servants, employees, invitees, visitors, guests or licensees of Tenant or its Transferees or any such person, in, on or about the Project (collectively, "Tenant Parties"); (iii) any breach, violation or non-performance by Tenant or Tenant Parties of any term, covenant or provision of this Lease or any Applicable Laws; or (iv) the placement of any of Tenant's Rooftop Equipment; or (v) the placement or usage of Tenant's Security System; provided that the terms of the foregoing indemnity shall not apply if and from the time that a final adjudication has resulted in a finding of willful misconduct or gross negligence of Landlord or a Landlord Party. Should Landlord be named as a defendant in any suit brought against Tenant in connection with or arising out of Tenant's occupancy of the Premises, Tenant shall pay to Landlord its actual and reasonable costs and expenses incurred in such suit, including without limitation, its actual and reasonable professional fees such as appraisers', accountants' and attorneys' fees. Further, Tenant's agreement to indemnify Landlord pursuant to this Section 10.1 is not intended and shall not relieve any insurance carrier of its obligations under policies required to be carried by Tenant pursuant to the provisions of this Lease, to the extent such policies cover the matters subject to Tenant's indemnification obligations; nor shall they supersede any inconsistent agreement of the parties set forth in any other provision of this Lease. Landlord shall indemnify, defend, protect, and hold harmless Tenant and Tenant Parties from any and all loss, cost, damage, expense and liability (including without limitation reasonable attorneys' fees) arising from the gross negligence or willful misconduct of Landlord in, on or about the Project, or Landlord's breach of the terms of this Lease beyond all applicable notice and cure periods, except to the extent caused by the negligence or willful misconduct of Tenant or the Tenant Parties. The provisions of this Section 10.1 shall survive the expiration or earlier termination of this Lease with respect to any Losses arising in connection with any event occurring prior to such expiration or termination.
  • Tenant's Compliance With Landlord's Property Insurance. Landlord shall insure the Building during the Lease Term against loss or damage under an "all risk" property insurance policy. Such coverage shall be in such amounts, from such companies, and on such other terms and conditions, as Landlord may from time to time reasonably determine. Additionally, at the option of Landlord, such insurance coverage may include the risks of earthquakes and/or flood damage and additional hazards, a rental loss endorsement and one or more loss payee endorsements in favor of the holders of any mortgages or deeds of trust encumbering the interest of Landlord in the Building or the ground or underlying lessors of the Building, or any portion thereof. Tenant shall, at Tenant's expense, comply with all insurance company requirements pertaining to the use of the Premises. If Tenant's conduct or use of the Premises (other than for the Permitted Use) causes any increase in the premium for such insurance policies then Tenant shall reimburse Landlord for any such increase. Tenant, at Tenant's expense, shall comply with all rules, orders, regulations or requirements of the American Insurance Association (formerly the National Board of Fire Underwriters) and with any similar body. Tenant shall also provide Landlord and Landlord's insurer(s) with such information regarding the use of the Premises and any damage to the Premises as they may require in connection with the placement of insurance for the Premises or the adjusting of any losses to the Premises.
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  • Tenant's Insurance. Tenant shall maintain the following coverages in the following amounts.
  • Commercial General Liability Insurance on an occurrence form covering the insured against claims of bodily injury, personal injury and property damage (including loss of use thereof) arising out of Tenant's operations, and contractual liabilities including a contractual coverage, and including products and completed operations coverage, for limits of liability on a per location basis of not less than:
Bodily Injury and<br><br>Property Damage Liability $2,000,000 each occurrence<br><br>$3,000,000 annual aggregate
Personal Injury Liability $2,000,000 each occurrence<br><br>$3,000,000 annual aggregate
  • Property Insurance covering (i) all office furniture, business and trade fixtures, office equipment, free-standing cabinet work, movable partitions, merchandise and all other items of Tenant's property on the Premises installed by, for, or at the expense of Tenant, (ii) the "Tenant Improvements," as that term is defined in the Tenant Work Letter, and any other improvements which exist in the Premises as of the Lease Commencement Date (excluding the Base Building) (the "Original Improvements"), and (iii) all other improvements, alterations and additions to the Premises made by Tenant or at the request of Tenant. Such insurance shall be written on an "all risks" of physical loss or damage basis, for the full replacement cost value (subject to reasonable deductible amounts) new without deduction for depreciation of the covered items and in amounts that meet any co-insurance clauses of the policies of insurance and shall include coverage for damage or other loss caused by fire or other peril including, but not limited to, vandalism and malicious mischief, theft, water damage of any type, including sprinkler leakage, bursting or stoppage of pipes, and explosion (but not including flood insurance, it being agreed that Tenant may self-insure with regard to such flood damage risk and Tenant hereby waives any right it may have against Landlord with respect to any damage or loss that would otherwise have been covered by the flood insurance coverage, including, without limitation, any loss of or damage to Tenant's personal property and/or furniture, fixtures or equipment).
  • Business Income Interruption for six (6) months plus Extra Expense insurance in such amounts as will reimburse Tenant for actual direct or indirect loss of earnings attributable to the risks outlined in Section 10.3.2 above.
  • Worker's Compensation and Employer's Liability or other similar insurance pursuant to all applicable state and local statutes and regulations. The policy shall include a waiver of subrogation in favor of Landlord, its employees, Lenders and any property manager or partners.
  • Form of Policies. The minimum limits of policies of insurance required of Tenant under this Lease shall in no event limit the liability of Tenant under this Lease. Such insurance shall (i) name Landlord, its subsidiaries and affiliates, its property manager (if any) and any other party the Landlord so specifies, as an additional insured or loss payee, as applicable, including Landlord's managing agent, if any; (ii) be issued by an insurance company having a rating of not less than A:IX in Best's Insurance Guide or which is otherwise acceptable to Landlord and licensed to do business in the State of California; (iv) be primary insurance as to all claims thereunder and provide that any insurance carried by Landlord is excess and is non-contributing with any insurance required of Tenant; (v) be in commercially reasonable form and content reasonably acceptable to Landlord; and (vi) provide that said insurance shall not be canceled or coverage changed unless thirty (30) days' prior written notice shall have been given to Landlord and any mortgagee of Landlord (unless such cancellation is the result of non-payment of premiums). Tenant shall deliver said policy or policies or certificates thereof to Landlord on or before the Lease Commencement Date and at least ten (10) days before the expiration dates thereof. In the event Tenant shall fail to procure such insurance, or to deliver such policies or certificate, and such failure continues for three (3) business days following written notice to Tenant, Landlord may, at its option, procure such policies for the account of Tenant, and the cost thereof shall be paid to Landlord within five (5) days after delivery to Tenant of bills therefor.
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  • Subrogation. Landlord and Tenant intend that their respective property loss risks shall be borne by their insurance carriers, and Landlord and Tenant hereby agree to look solely to, and seek recovery only from, their respective insurance carriers in the event of a property or business interruption loss to the extent that such coverage is agreed to be provided hereunder. The parties each hereby waive all rights and claims against each other for such losses, and waive all rights of subrogation of their respective insurers, provided such waiver of subrogation shall not affect the right to the insured to recover thereunder. The parties agree that their respective insurance policies do now, or shall, contain the waiver of subrogation.
  • Additional Insurance Obligations. Tenant shall carry and maintain during the entire Lease Term, at Tenant's sole cost and expense, increased amounts of the insurance required to be carried by Tenant pursuant to this Article 10 and such other reasonable types of insurance coverage and in such reasonable amounts covering the Premises and Tenant's operations therein, as may be reasonably requested by Landlord or Landlord's lender, but in no event in excess of the amounts and types of insurance then being required by landlords of buildings comparable to and in the vicinity of the Building. Notwithstanding anything to the contrary contained herein, provided, that, Tenant’s use of the Premises does not substantially change over the initial Lease Term or trigger an additional insurance coverage requirement from Landlord's insurers, Landlord may not increase the amounts of insurance required to be carried by Tenant more than once during the initial Lease Term. In addition, Tenant shall pay for any increase in the premiums for the property insurance of the Project carried by Landlord if said increase is caused solely and directly by Tenant's acts, omissions, use or occupancy of the Premises.
  • DAMAGE AND DESTRUCTION
  • Repair of Damage. Tenant shall promptly notify Landlord of any damage to the Premises resulting from fire or any other casualty ("Casualty"). If the Premises or any Common Areas or other portions of the Project serving or providing access to the Premises shall be damaged by Casualty, Landlord shall promptly and diligently, subject to reasonable delays for insurance adjustment or other matters beyond Landlord's reasonable control, and subject to all other terms of this Article 11, restore the Base Building and such Common Areas and portions of the Project. Such restoration shall be to substantially the same condition of the Base Building and the Common Areas and Project prior to the Casualty, except for modifications required by zoning and building codes and other laws or by the holder of a mortgage on the Building or Project or any other modifications to the Common Areas deemed desirable by Landlord, which are consistent with the character of the Project, provided that Tenant's use of and access to the Premises shall not be materially impaired. Subject to the terms of Section 11.2, below, Tenant shall, at its sole cost and expense, repair any injury or damage to the Tenant Improvements, the Original Improvements and any Alterations installed in the Premises and shall return such Tenant Improvements, Original Improvements and any Alterations to their original condition, unless Tenant and Landlord mutually agree in writing upon a new condition to restore the Premises (in each party's sole and absolute discretion). Whether or not Landlord delivers a "Landlord Repair Notice," as that term is defined in Section 11.2 below, prior to the commencement of construction, Tenant shall submit to Landlord, for Landlord's review and approval, not to be unreasonably withheld, conditioned, or delayed, all plans, specifications and working drawings relating thereto, and Landlord shall select the contractors to perform such improvement work. Tenant shall in addition cooperate with requests for information regarding any repairs from Landlord's insurer(s) by providing the requested information within ten (10) business days after Tenant receives the request. Landlord shall not be liable for any inconvenience or annoyance to Tenant or its visitors, or injury to Tenant's business resulting in any way from such damage or the repair thereof; provided however, that if such Casualty shall have damaged the Premises or Common Areas or portions of the Project necessary to Tenant's occupancy, and the Premises are not occupied by Tenant as a result thereof, then during the time and to the extent the Premises are unfit for occupancy, the Rent shall be abated in proportion to the ratio that the amount of rentable square feet of the Premises which is unfit for occupancy for the purposes permitted under this Lease bears to the total rentable square feet of the Premises. In the event that Landlord shall not deliver the Landlord Repair Notice, Tenant's right to rent abatement pursuant to the preceding sentence shall terminate as of the date which is reasonably determined by Landlord to be the date Tenant should have completed repairs to the Premises assuming Tenant used reasonable due diligence in connection therewith. Notwithstanding any contrary provision of this Article 11, the parties hereby agree the closure of the Project, the Building, the Common Areas, or any part thereof to protect public health shall not constitute a Casualty for purposes of this Lease.
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  • Landlord's Option to Repair. Upon the occurrence of any damage to the Premises, Landlord may, at Landlord's option, deliver a written notice (the “Landlord Repair Notice”) to Tenant, and upon receipt of a Landlord Repair Notice Tenant shall assign to Landlord (or to any party designated by Landlord) all insurance proceeds payable to Tenant under Tenant's insurance required under Section 10.3 of this Lease, and Landlord shall repair any injury or damage to the Tenant Improvements, the Original Improvements and any Alterations installed in the Premises and shall return such Tenant Improvements, the Original Improvements and any Alterations to their original condition; provided that if the cost of such repair by Landlord exceeds the amount of insurance proceeds received by Landlord from Tenant's insurance carrier (including by taking into account any deductible or self-insured retention), as assigned by Tenant, the cost of such repairs shall be paid by Tenant to Landlord prior to Landlord's commencement of repair of the damage (provided, that, to the extent feasible (as reasonably determined by Landlord), Landlord shall cause such repair work to be competitively bid to at least three [3] general contractors), with all incurred expenses available for Tenant’s review upon demand on an "open book" basis. Notwithstanding the terms of Section 11.1 of this Lease, Landlord may elect not to rebuild and/or restore the Premises, Building and/or Project, and instead terminate this Lease, by notifying Tenant in writing of such termination within sixty (60) days after the date of discovery of the damage, such notice to include a termination date giving Tenant sixty (60) days to vacate the Premises, but Landlord may so elect only if the Building or Project shall be damaged by Casualty, whether or not the Premises are affected, and one or more of the following conditions is present: (i) in Landlord's reasonable judgment, repairs cannot reasonably be completed within two hundred seventy (270) days after the date of discovery of the damage (when such repairs are made without the payment of overtime or other premiums); (ii) the holder of any mortgage on the Building or Project or ground lessor with respect to the Building or Project shall require that the insurance proceeds or any portion thereof be used to retire the mortgage debt, or shall terminate the ground lease, as the case may be; (iii) the damage is not fully covered by Landlord's insurance policies; (iv) intentionally omitted; or (v) any owner of any other portion of the Project, other than Landlord, does not intend to repair the damage to such portion of the Project; provided, however, that if Landlord does not elect to terminate this Lease pursuant to Landlord's termination right as provided above, and the repairs cannot, in the reasonable opinion of Landlord, be completed within two hundred seventy (270) days after being commenced, Tenant may elect, no earlier than sixty (60) days after the date of the damage and not later than one hundred twenty(120) days after the date of such damage, to terminate this Lease by written notice to Landlord effective as of the date specified in the notice, which date shall not be less than thirty (30) days nor more than sixty (60) days after the date such notice is given by Tenant. In addition, if (1) the Premises, the Building or any portion of the Project is destroyed or damaged to any substantial extent during the last twelve (12) months of the Lease Term, (2) Tenant has not exercised its Extension Option that is still in effect, and does not exercise such Extension Option within thirty (30) days after the date of Landlord's Repair Notice, and (3) Landlord's restoration work required under this Article 11 is reasonably estimated by Landlord in Landlord's Repair Notice to require more than one hundred twenty (120) days or the remainder of the Lease Term (whichever is less) to complete, then notwithstanding anything contained in this Article 11, Landlord shall have the option to terminate this Lease, and to the extent that clauses (a) through (c) below are satisfied, Tenant shall have the option to terminate this Lease, by giving written termination notice to the other party of the exercise of such option within thirty (30) days after such damage or destruction, in which event this Lease shall cease and terminate as of the date of such notice. Notwithstanding the provisions of this Section 11.2, Tenant shall have the right to terminate this Lease under this Section 11.2 only if each of the following conditions is satisfied: (a) the damage to the Project by Casualty was not caused by the gross negligence or intentional act of Tenant or its partners or subpartners and their respective officers, agents, servants, employees, and independent contractors; (b) Tenant is not then in default under this Lease beyond all applicable notice and cure periods; and (c) as a result of the damage, Tenant cannot reasonably conduct business from the Premises.
  • Waiver of Statutory Provisions. The provisions of this Lease, including this Article 11, constitute an express agreement between Landlord and Tenant with respect to any and all damage to, or destruction of, all or any part of the Premises, the Building or the Project, and any statute or regulation of the State of California, including, without limitation, Sections 1932(2) and 1933(4) of the California Civil Code, with respect to any rights or obligations concerning damage or destruction in the absence of an express agreement between the parties, and any other statute or regulation, now or hereafter in effect, shall have no application to this Lease or any damage or destruction to all or any part of the Premises, the Building or the Project.
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  • NONWAIVER. No provision of this Lease shall be deemed waived by either party hereto unless expressly waived in a writing signed by the waiving party. The waiver by either party hereto of any breach of any term, covenant or condition herein contained shall not be deemed to be a waiver of any subsequent breach of same or any other term, covenant or condition herein contained. The subsequent acceptance of Rent hereunder by Landlord shall not be deemed to be a waiver of any preceding breach by Tenant of any term, covenant or condition of this Lease, other than the failure of Tenant to pay the particular Rent so accepted, regardless of Landlord's knowledge of such preceding breach at the time of acceptance of such Rent. No acceptance of a lesser amount than the Rent herein stipulated shall be deemed a waiver of Landlord's right to receive the full amount due, nor shall any endorsement or statement on any check or payment or any letter accompanying such check or payment be deemed an accord and satisfaction, and Landlord may accept such check or payment without prejudice to Landlord's right to recover the full amount due. No receipt of monies by Landlord from Tenant after the termination of this Lease shall in any way alter the length of the Lease Term or of Tenant's right of possession hereunder, or after the giving of any notice shall reinstate, continue or extend the Lease Term or affect any notice given Tenant prior to the receipt of such monies, it being agreed that after the service of notice or the commencement of a suit, or after final judgment for possession of the Premises, Landlord may receive and collect any Rent due, and the payment of said Rent shall not waive or affect said notice, suit or judgment.
  • CONDEMNATION. If the whole or any part of the Premises, Building or Project shall be taken by power of eminent domain or condemned by any competent authority for any public or quasi-public use or purpose, or if any adjacent property or street shall be so taken or condemned, or reconfigured or vacated by such authority in such manner as to require the use, reconstruction or remodeling of any part of the Premises, Building or Project, or if Landlord shall grant a deed or other instrument in lieu of such taking by eminent domain or condemnation, Landlord shall have the option to terminate this Lease effective as of the date possession is required to be surrendered to the authority. In addition, if more than twenty-five percent (25%) of the rentable square feet of the Premises is taken, or if access to the Premises is substantially impaired (and reasonably sufficient alternative access cannot be provided by Landlord), in each case by a period in excess of one hundred eighty (180) consecutive days, Tenant shall have the option to terminate this Lease effective as of the date possession is required to be surrendered to the authority. Tenant shall not because of such taking assert any claim against Landlord or the authority for any compensation because of such taking and Landlord shall be entitled to the entire award or payment in connection therewith, except that Tenant shall have the right to file any separate claim available to Tenant for any taking of Tenant's personal property and fixtures belonging to Tenant and removable by Tenant upon expiration of the Lease Term pursuant to the terms of this Lease, and for moving expenses, so long as such claims do not diminish the award available to Landlord, its ground lessor with respect to the Building or Project or its mortgagee, and such claim is payable separately to Tenant. All Rent shall be apportioned as of the date of such termination. If any part of the Premises shall be taken, and this Lease is not terminated, the Rent under this Lease shall be proportionately reduced based on the portion of the Premises subject to the applicable taking. Tenant hereby waives any and all rights it might otherwise have pursuant to Section 1265.130 of the California Code of Civil Procedure. Notwithstanding anything to the contrary contained in this Article 13, in the event of a temporary taking of all or any portion of the Premises for a period of one hundred and eighty (180) days or less, then this Lease shall not terminate but the Base Rent and Tenant's Share of Direct Expenses shall be abated for the period of such taking in proportion to the ratio that the amount of rentable square feet of the Premises taken bears to the total rentable square feet of the Premises. Landlord shall be entitled to receive the entire award made in connection with any such temporary taking, provided, however, that Tenant shall have the right to file any separate claim available to Tenant for any taking of Tenant's personal property and fixtures belonging to Tenant and removable by Tenant upon expiration of the Lease Term pursuant to the terms of this Lease, and for moving expenses, so long as such claim does not diminish the award available to Landlord, or its ground lessor or mortgagee with respect to the Project, and such claim is payable separately to Tenant. Notwithstanding any contrary provision of this Lease, the following governmental actions (whether through regulatory action, ordinance, or otherwise) shall not constitute a taking or condemnation, either permanent or temporary: (i) an action that requires Tenant's business to close during the Lease Term, (ii) an action that limits or temporarily prohibits access to or use of the Building or Premises, and (iii) an action taken for the purpose of protecting public safety (e.g., to protect against acts of war, the spread of communicable diseases, or an infestation), and no such governmental actions shall entitle Tenant to any compensation from Landlord or any authority, or Rent abatement or any other remedy under this Lease.
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  • ASSIGNMENT AND SUBLETTING
  • Transfers. Except in connection with a Permitted Transfer (as defined below), Tenant shall not, without the prior written consent of Landlord (not to be unreasonably withheld, conditioned, or delayed), assign, sublet, license, mortgage, pledge, hypothecate, encumber, or transfer this Lease or the Premises in whole or in part whether by changes in the ownership or control of Tenant, or any direct or indirect owner of Tenant, whether at one time or at intervals, by sale or transfer of stock, partnership or beneficial interests, operation of law or otherwise, or permit the occupancy or use of the Premises or any part thereof by any persons other than Tenant and its employees and contractors (all of the foregoing are hereinafter sometimes referred to collectively as "Transfers" and any person to whom any Transfer is made or sought to be made is hereinafter sometimes referred to as a "Transferee"). If Tenant desires Landlord's consent to any Transfer, Tenant shall notify Landlord in writing, with a copy simultaneously delivered via email to Landlord and with a copy delivered via email to which notice (the "Transfer Notice") shall include (i) the proposed effective date of the Transfer, which shall not be less than thirty (30) days nor more than one hundred eighty (180) days after the date of delivery of the Transfer Notice, (ii) a description of the portion of the Premises to be transferred (the "Subject Space"), (iii) all of the terms of the proposed Transfer and the consideration therefor, including calculation of the "Transfer Premium" (as that term is defined in Section 14.3 below) in connection with such Transfer, the name and address of the proposed Transferee, and a copy of all existing executed and/or proposed documentation pertaining to the proposed Transfer, including all existing operative documents to be executed to evidence such Transfer or the agreements incidental or related to such Transfer, provided that Landlord shall have the right to require Tenant to utilize Landlord's standard consent to Transfer documents in connection with the documentation of Landlord's consent to such Transfer, subject to commercially reasonable modifications, (iv) current financial statements of the proposed Transferee certified by an officer, partner or owner thereof, business credit and personal references and history of the proposed Transferee and any other commercially reasonable information reasonably required by Landlord which will enable Landlord to determine the "Net Worth" (as that term is defined in Section 14.8 below) and the financial responsibility, character, and reputation of the proposed Transferee, nature of such Transferee's business and proposed use of the Subject Space, (v) a complete statement, certified by an independent certified public accountant, or Tenant's chief financial officer, setting forth in detail the computation of any Transfer Premium Tenant has derived and shall derive from such Transfer, and (vi) an executed estoppel certificate from Tenant in the form attached hereto as Exhibit D. Any Transfer made without Landlord's prior written consent shall, at Landlord's option, be null, void and of no effect, and shall, at Landlord's option, constitute an Event of Default by Tenant under this Lease. Whether or not Landlord consents to any proposed Transfer, Tenant shall pay Landlord's actual and reasonable out-of-pocket review and processing fees, as well as any reasonable professional fees (including, without limitation, attorneys', accountants', architects', engineers' and consultants' fees) incurred by Landlord, within thirty (30) days after written request by Landlord. Notwithstanding anything contained in this Lease to the contrary, Tenant shall not: (a) make a Transfer to an entity in which, under the Internal Revenue Code of 1986, as amended (the "Code"), any entity that directly or indirectly owns Landlord and is qualified as a real estate investment trust (a "REIT Owner") owns, directly, indirectly or by applying constructive ownership rules set forth in Section 856(d)(5) of the Code, a ten percent (10%) or greater interest; or (ii) make any Transfer or other action under Section 14.8, below, in a manner that would cause any portion of the amounts received by Landlord pursuant hereto to fail to qualify as "rents from real property" within the meaning of Section 856(d) of the Code.
  • Landlord's Consent. Landlord shall not unreasonably withhold or condition its consent to any proposed Transfer of the Subject Space to the Transferee on the terms specified in the Transfer Notice, and shall notify Tenant whether the proposed Transferee is approved or reasonably disapproved within twenty-five (25) days after Landlord's receipt of Tenant's Transfer Notice, provided a copy of Tenant's Transfer Notice was simultaneously delivered to Landlord via email and with a copy delivered via email to. Without limitation as to other reasonable grounds for withholding consent, it shall be reasonable under this Lease and under Applicable Laws for Landlord to withhold consent to any proposed Transfer where one or more of the following apply:
  • By Landlord's commercially reasonable determination, the Transferee is of a character or reputation or engaged in a business which is not consistent with the quality of the Building or the Project;
  • The Transferee is either a governmental agency or instrumentality thereof;
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  • By Landlord's commercially reasonable determination, the Transferee is not a party of reasonable financial worth and/or financial stability in light of the responsibilities to be undertaken in connection with the Transfer on the date consent is requested;
  • Such Transfer would cause a REIT Owner to be in violation of applicable Code requirements for it to maintain status as a "real estate investment trust" under Sections 856 through 860 of the Code or would violate any provision of this Section 14.1;
  • The proposed Transfer would cause a violation of another lease for space in the Project, or would give an occupant of the Project a right to cancel its lease;
  • The Transferee intends to use the Subject Space for purposes which are not permitted under this Lease; or
  • Either the proposed Transferee, or any person or entity which directly or indirectly, controls, is controlled by, or is under common control with, the proposed Transferee, is negotiating with Landlord to lease space in the Project at such time, or has negotiated with Landlord during the twelve (12)-month period immediately preceding the Transfer Notice.

If Landlord consents to any Transfer pursuant to the terms of this Section 14.2 (and does not exercise any recapture rights Landlord may have under Section 14.4 of this Lease), Tenant may within six (6) months after Landlord's consent, but not later than the expiration of said six (6)-month period, enter into such Transfer of the Premises or portion thereof, upon substantially the same terms and conditions as are set forth in the Transfer Notice furnished by Tenant to Landlord pursuant to Section 14.1 of this Lease, provided that if there are any material changes in the terms and conditions from those specified in the Transfer Notice such that Landlord would initially have been entitled to refuse its consent to such Transfer under this Section 14.2, Tenant shall again submit the Transfer to Landlord for its approval and other action under this Article 14 (including Landlord's right of recapture, if any, under Section 14.4 of this Lease). Notwithstanding anything to the contrary in this Lease, if Tenant or any proposed Transferee claims that Landlord has unreasonably withheld or delayed its consent under Section 14.2 or otherwise has breached or acted unreasonably under this Article 14, their sole remedies shall be declaratory judgment and an injunction for the relief sought without monetary damages, and Tenant hereby waives the provisions of Section 1995.310 of the California Civil Code, or any successor statute, and all other remedies, including, without limitation, any right at law or equity to terminate this Lease, on its own behalf and, to the extent permitted under all Applicable Laws, on behalf of the proposed Transferee.

  • Transfer Premium. If Landlord consents to any Transfer, other than a Permitted Transfer, as a condition thereto which the parties hereby agree is reasonable, Tenant shall pay to Landlord fifty percent (50%) of any Transfer Premium received by Tenant from such Transferee (or any subsequent Transferee, e.g., a sub-subtenant) in connection with the Transfer. "Transfer Premium" shall mean all rent, additional rent or other consideration payable by such Transferee in connection with the Transfer in excess of the Base Rent and Tenant's Share of Direct Expenses payable by Tenant under this Lease during the term of the Transfer (which shall be calculated on a per rentable square foot basis if less than all of the Premises is transferred, after deducting the reasonable expenses incurred by Tenant for (i) any changes, alterations and improvements made to the Premises in order to procure the particular Transfer, (ii) brokerage commissions in connection with the particular Transfer, (iii) reasonable legal fees in negotiating the particular Transfer, (iv) reasonable costs incurred for downtime during the marketing period, (v) any free base rent that is customary and market for Comparable Buildings and reasonably provided to the Transferee in connection with the Transfer (provided that such free rent shall be deducted only to the extent the same is included in the calculation of the total consideration payable by such Transferee), (vi) fees paid to Landlord in connection with Tenant's request for consent under this Article 14, and (vii) other concessions reasonably required to induce a substance to sublease the Premises. Transfer Premium shall also include, but not be limited to, key money, bonus money or other cash consideration paid by Transferee to Tenant in connection with such Transfer, and any payment in excess of fair market value for services rendered by Tenant to Transferee or for assets, fixtures, inventory, equipment, or furniture transferred by Tenant to Transferee in connection with such Transfer. Landlord or its authorized representatives shall have the right at all reasonable times and upon reasonable prior written notice of not less than three (3) business days to audit the books, records and papers of Tenant relating to the calculation of any Transfer Premium at Tenant's on-site office (or otherwise, by electronic record delivery) and shall have the right to
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  • make copies thereof, provided, that, prior to the same, Landlord will provide Landlord's form of non-disclosure agreement pertaining to such information. If the Transfer Premium respecting any Transfer shall be found understated, Tenant shall, within thirty (30) days after demand, pay the deficiency, and if understated by more than three percent (3%), Tenant shall pay Landlord's costs of such audit.
  • Landlord's Option as to Subject Space. Notwithstanding anything to the contrary contained in this Article 14, in the event Tenant contemplates a Transfer which, together with all prior Transfers, other than to a Permitted Transferee, then remaining in effect, would cause sixty percent (60%) or more of the Premises to be Transferred for more than seventy-five percent (75%) of the then remaining Lease Term (taking into account any extension of the Lease Term which has irrevocably exercised by Tenant), Tenant shall give Landlord notice (the "Intention to Transfer Notice") of such contemplated Transfer (whether or not the contemplated Transferee or the terms of such contemplated Transfer have been determined). The Intention to Transfer Notice shall specify the portion of and amount of rentable square feet of the Premises which Tenant intends to Transfer (the "Contemplated Transfer Space"), the contemplated date of commencement of the Contemplated Transfer (the "Contemplated Effective Date"), and the contemplated length of the term of such contemplated Transfer, and shall specify that such Intention to Transfer Notice is delivered to Landlord pursuant to this Section 14.4 in order to allow Landlord to elect to recapture the Contemplated Transfer Space. Thereafter, Landlord shall have the option, by giving written notice to Tenant ("Landlord's Recapture Notice") within twenty (20) days after receipt of any Intention to Transfer Notice, to recapture the Contemplated Transfer Space. Such recapture shall cancel and terminate this Lease with respect to such Contemplated Transfer Space as of the Contemplated Effective Date. Notwithstanding the foregoing, Tenant may withdraw its Intention to Transfer Notice within five (5) days of receipt of Landlord's Recapture Notice, in which event any such election to recapture shall be null and void and this Lease shall continue in full force and effect, but Tenant shall not be entitled to proceed with the contemplated Transfer which was the subject of Tenant's original Intention to Transfer Notice, and Tenant shall again be required to submit a new Intention to Transfer Notice to Landlord with respect to any contemplated Transfer, as provided above in this Section 14.4. In the event of a recapture by Landlord and termination of this Lease with respect to less than the entire Premises, the Base Rent and Tenant's Share of Direct Expenses shall be equitably prorated on the basis of the number of rentable square feet retained by Tenant in proportion to the number of rentable square feet contained in the Premises, and this Lease as so amended shall continue thereafter in full force and effect, and upon request of either party, the parties shall execute written confirmation of the same. If Landlord declines, or fails to elect in a timely manner, to recapture such Contemplated Transfer Space under this Section 14.4, then, subject to the other terms of this Article 14, for a period of nine (9) months (the "Nine Month Period") commencing on the last day of such twenty (20) day period, Landlord shall not have any right to recapture the Contemplated Transfer Space with respect to any Transfer made during the Nine Month Period, provided that any such Transfer is substantially on the terms set forth in the Intention to Transfer Notice, and provided further that any such Transfer shall be subject to the remaining terms of this Article 14. If such a Transfer is not so consummated within the Nine Month Period (or if a Transfer is so consummated, then upon the expiration of the term of any Transfer of such Contemplated Transfer Space consummated within such Nine Month Period), Tenant shall again be required to submit a new Intention to Transfer Notice to Landlord with respect any contemplated Transfer, as provided above in this Section 14.4.
  • Effect of Transfer. If Landlord consents to any Transfer, (i) the terms and conditions of this Lease shall in no way be deemed to have been waived or modified, (ii) such consent shall not be deemed consent to any further Transfer by either Tenant or a Transferee, and (iii) no Transfer relating to this Lease or agreement entered into with respect thereto, whether with or without Landlord's consent, shall relieve Tenant or any guarantor of the Lease from any liability under this Lease, including, without limitation, in connection with the Subject Space.
  • Intentionally Omitted.
  • Occurrence of Default. Any Transfer shall be subordinate and subject to the provisions of this Lease, and if this Lease shall be terminated during the term of any Transfer, Landlord shall have the right to: (i) treat such Transfer as cancelled and repossess the Subject Space by any lawful means, or (ii) require that such Transferee attorn to and recognize Landlord as its landlord under any such Transfer. If Tenant shall be in an Event of Default under this Lease, Landlord is hereby irrevocably authorized to direct any Transferee to make all payments under or in connection with the Transfer directly to Landlord (which Landlord shall apply towards Tenant's obligations under this Lease) until such Event of Default is cured. Such Transferee shall rely on any representation by Landlord that Tenant is in an Event of Default hereunder, without any need for confirmation thereof by Tenant. Upon any
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  • assignment, the assignee shall assume in writing all obligations and covenants of Tenant thereafter to be performed or observed under this Lease. No collection or acceptance of rent by Landlord from any Transferee shall be deemed a waiver of any provision of this Article 14 or the approval of any Transferee or a release of Tenant from any obligation under this Lease, whether theretofore or thereafter accruing. In no event shall Landlord's enforcement of any provision of this Lease against any Transferee be deemed a waiver of Landlord's right to enforce any term of this Lease against Tenant or any other person. If Tenant's obligations hereunder have been guaranteed, Landlord's consent to any Transfer shall not be effective unless the guarantor also consents to such Transfer.
  • Permitted Transfers. Notwithstanding anything to the contrary set forth in this Lease, Landlord shall not withhold its consent to a Transfer which (i) is an assignment or subletting of all or a portion of the Premises to an affiliate of Tenant, which for purposes of this Lease shall mean an entity which is controlled by, controls, or is under common control with, Tenant as of the Effective Date (an "Affiliate"), (ii) is a sale of corporate shares of capital stock in Tenant in connection with an initial public offering of Tenant's stock on a nationally-recognized stock exchange, (iii) is an assignment of the Lease to an entity which acquires all or substantially all of the stock or assets of Tenant, (iv) is an assignment of the Lease to an entity which is the resulting entity of a merger or consolidation of Tenant during the Lease Term or (v) results in a change in control of Tenant due to a merger or consolidation (any such merger, consolidation, assignment or sublease, a "Permitted Transfer", and any such assignee, sublessee or surviving Tenant shall be hereinafter referred to as a "Permitted Transferee"), provided that (a) Tenant notifies Landlord at least ten (10) days prior to the effective date of any contemplated Permitted Transfer and promptly supplies Landlord with any documents or information reasonably requested by Landlord regarding such Permitted Transfer or Permitted Transferee, provided, however, if such prior notice or information hereinabove would otherwise be a breach of a confidentiality agreement to which Tenant is bound and/or a violation of Applicable Laws, then Tenant shall provide notice of such contemplated Permitted Transfer to Landlord within a commercially reasonable period of time after the effective date of such contemplated Permitted Transfer, (b) Tenant delivers evidence of insurance as required under this Lease with respect to the Permitted Transferee, (c) Tenant is not in an Event of Default under this Lease, and such Transfer is not a subterfuge by Tenant to avoid its obligations under this Lease, (d) such Permitted Transferee shall be of a character and reputation reasonably consistent and compatible with the operation and quality of the Project, (e) such Permitted Transferee shall have a tangible net worth (not including intangibles, such as goodwill, as an asset) computed in accordance with generally accepted accounting principles ("Net Worth") and other financial indicators sufficient to meet Tenant's obligations under the Transfer instrument in question and its obligations hereunder, (f) Tenant shall not be relieved from any liability under this Lease, (g) the liability of such Permitted Transferee under either an assignment or sublease shall be joint and several with Tenant, and (h) Tenant and the Permitted Transferee shall execute and deliver to Landlord, prior to the effective date of the Transfer (and as a condition to the effectiveness of the Transfer), Landlord's then-standard and commercially reasonable form of acknowledgement representing that the conditions of this Section 14.8 are true and accurate with respect to such Transfer. The occurrence of a Transfer pursuant to this Section 14.8 shall not waive Landlord's rights as to any subsequent Transfers. The right to Transfer to an Affiliate pursuant to Section 14.8(i) shall be subject to the condition that such Permitted Transferee remains an Affiliate of Tenant and that if such Permitted Transferee ceases to be an Affiliate of Tenant, it shall so notify Landlord in writing within ten (10) days after such event and, upon the written request of Landlord, transfer, assign, set over and/or re-assign this Lease and its interest in the Premises, as applicable, to Tenant or, subject to complying with this condition, another Affiliate of Tenant.
  • SURRENDER OF PREMISES; OWNERSHIP AND REMOVAL OF TRADE FIXTURES
  • Surrender of Premises. No act or thing done by Landlord or any agent or employee of Landlord during the Lease Term shall be deemed to constitute an acceptance by Landlord of a surrender of the Premises unless such intent is specifically acknowledged in writing by Landlord. The delivery of keys to the Premises to Landlord or any agent or employee of Landlord shall not constitute a surrender of the Premises or effect a termination of this Lease, whether or not the keys are thereafter retained by Landlord, and notwithstanding such delivery Tenant shall be entitled to the return of such keys at any reasonable time upon request until this Lease shall have been properly terminated. The voluntary or other surrender of this Lease by Tenant, whether accepted by Landlord or not, or a mutual termination hereof, shall not work a merger, and at the option of Landlord shall operate as an assignment to Landlord of all subleases or subtenancies affecting the Premises or terminate any or all such sublessees or subtenancies.
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  • Removal Requirements. Upon the expiration of the Lease Term, or upon any earlier termination of this Lease, Tenant shall, subject to the provisions of this Article 15, quit and surrender possession of the Premises to Landlord in as good order and condition as when Tenant took possession and as thereafter improved by Landlord and/or Tenant, reasonable wear and tear and repairs which are specifically made the responsibility of Landlord hereunder, and Casualty excepted. Upon such expiration or termination, Tenant shall, without expense to Landlord, remove or cause to be removed from the Premises all debris and rubbish, and such items of furniture, equipment, free-standing cabinet work, movable partitions and other articles of personal property owned by Tenant or installed or placed by Tenant at its expense in the Premises, and such similar articles of any other persons claiming under Tenant, as Landlord may, in its sole discretion, require to be removed (except to the extent Landlord notified Tenant in writing that the same would not be required for removal), and Tenant shall repair at its own expense all damage to the Premises and Building resulting from such removal. However, in no event shall Tenant remove any lab benches from the Premises at the expiration of the Lease Term unless Tenant establishes (to Landlord's satisfaction) Tenant paid for such lab benches and they were not purchased using any tenant improvement allowance(s) provided by Landlord. With respect to any Alterations that are not required to be removed, Tenant shall leave the same in good working order and condition, deliver to Landlord all necessary user information such that the same may be used by a future occupant of the Premises (e.g., any water sensors that remain shall be unblocked and ready for use by a third-party). If Tenant fails to perform the foregoing removal, repair and restoration obligations, then at Landlord's option, either (i) Tenant shall be deemed to be holding over in the Premises and Rent shall continue to accrue in accordance with the terms of Article 16 below, until such work shall be completed, and/or (ii) Landlord may do so and may charge the cost thereof to Tenant.
  • Environmental Assessment. In connection with its surrender of the Premises, Tenant shall submit to Landlord, at least one hundred twenty (120) days prior to the Lease Expiration Date (or in the event of an earlier termination of this Lease, as soon as reasonably possible following such termination), an environmental Assessment of the Premises by a competent and experienced environmental engineer or engineering firm reasonably satisfactory to Landlord (pursuant to a contract approved by Landlord and providing that Landlord can rely on the Environmental Assessment), which (i) evidences that the Premises are in a clean and safe condition and free and clear of any Hazardous Materials introduced or Released by Tenant or Tenant’s Agents; and (ii) includes a review of the Premises by an environmental consultant for asbestos, mold, fungus, spores, and other moisture conditions, on-site chemical use, and lead-based paint. If such Environmental Assessment reveals that remediation or Clean-up is required under any Environmental Laws, Tenant shall submit a remediation plan prepared by a recognized environmental consultant and shall be responsible for all costs of remediation and Clean-up, as more particularly provided in Section 5.3, above.
  • Condition of the Building and Premises Upon Surrender. In addition to the above requirements of this Article 15, upon the expiration of the Lease Term, or upon any earlier termination of this Lease, Tenant shall, surrender the Premises and Building such that the same are in compliance with all Applicable Laws and with Tenant having complied with all of Tenant's obligations under this Lease, including those relating to improvement, repair, maintenance, compliance with law, testing and other related obligations of Tenant set forth in Article 7 of this Lease. In the event that the Building and Premises shall be surrendered in a condition which does not comply with the terms of this Section 15.4, because Tenant failed to comply with its obligations set forth in Lease, then following thirty (30) days' written notice to Tenant, during which thirty (30) day period Tenant shall have the right to cure such noncompliance, Landlord shall be entitled to expend all reasonable costs in order to cause the same to comply with the required condition upon surrender and Tenant shall reimburse Landlord with ten (10) business days of written request for all such costs upon notice and Tenant shall be deemed during the period that Tenant or Landlord, as the case may be, perform obligations relating to the Surrender Improvements to be in holdover under Article 16 of this Lease.
  • Disposal Rights. Without limiting any other rights or remedies of Landlord, any of Tenant's personal property not removed by Tenant upon the expiration of this Lease, or within forty-eight (48) hours after any early termination of this Lease, shall be considered abandoned and Landlord may, at its sole election (and regardless of the value of such property), (i) elect to take ownership of any or all of such property (in which event, subject to the rights of any third parties who have an ownership or security interest in any such property, Landlord may use, sell, or dispose of such property in Landlord's sole discretion), or (ii) store any or all of such property in a public warehouse or elsewhere (including at Landlord's property) for the account, and at the expense and risk, of Tenant. If Landlord elects to store Tenant's personal property, then Tenant shall pay the cost of storing the same to Landlord (based on the actual costs and expenses incurred by Landlord in connection therewith, plus a 5% administrative fee, or if the property
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  • is being stored at property owned or controlled by Landlord or its affiliates, based on the then fair market rental value of the applicable space, in all cases as reasonably determined by Landlord). If Landlord elects to store any such personal property in accordance with item (ii) above, then Landlord may thereafter elect to take ownership of such property pursuant to item (i) above at any time prior to Tenant recovering possession of the subject property. The terms and conditions of this Section 15.5 have been specifically bargained for, and, to the maximum extent permitted by law, Tenant expressly waives the right to receive any notices under California Civil Code Section 1993 et seq., or any other statutory procedures with respect to abandoned personal property.
  • HOLDING OVER. Unless otherwise agreed to by Landlord in writing (in Landlord's sole and absolute discretion) if Tenant holds over after the expiration of the Lease Term or earlier termination thereof, such tenancy shall be a tenancy at sufferance, and shall not constitute a renewal hereof or an extension for any further term, and in such case, daily damages in any action to recover possession of the Premises shall be calculated at a daily rate equal to one hundred twenty-five percent (125%) of the Base Rent applicable during the last rental period of the Lease Term under this Lease (calculated on a per diem basis) and one hundred percent (100%) of all other Rent applicable during the last rental period of the Lease Term under this Lease (calculated on a per diem basis) for the first three (3) months of the holdover and thereafter, starting on the first day of the fourth month of the holdover, at a daily rate equal to one hundred fifty percent (150%) of the amount applicable during the first month of the holdover (calculated on a per diem basis) and one hundred percent (100%) of all other Rent applicable during the last rental period of the Lease Term under this Lease (calculated on a per diem basis). Nothing contained in this Article 16 shall be construed as consent by Landlord to any holding over by Tenant, and Landlord expressly reserves the right to require Tenant to vacate and deliver possession of the Premises to Landlord as provided in this Lease upon the expiration or other termination of this Lease. The provisions of this Article 16 shall not be deemed to limit or constitute a waiver of any other rights or remedies of Landlord provided herein or at law. If Tenant holds over without Landlord's express written consent, and tenders payment of rent for any period beyond the expiration of the Lease Term by way of check (whether directly to Landlord, its agents, or to a lock box) or wire transfer, the cashing of such check or acceptance of such wire shall be considered inadvertent and not be construed as creating a month-to-month tenancy, provided Landlord refunds such payment to Tenant promptly upon learning that such check has been cashed or wire transfer received. Any holding over without Landlord's express written consent may compromise or otherwise affect Landlord's ability to enter into new leases with prospective tenants regarding the Premises. Therefore, if Tenant fails to vacate and deliver the Premises within fifteen (15) days following the termination or expiration of this Lease, in addition to any other Losses to Landlord accruing therefrom, Tenant shall protect, defend, indemnify and hold Landlord harmless from and against all claims made by any succeeding tenant founded upon such failure to vacate and deliver, and any Losses suffered by Landlord, including lost profits, resulting from such failure to vacate and deliver. In addition, Tenant shall be liable for all damages (including reasonable attorneys' fees and expenses) of whatever type (including consequential damages) incurred by Landlord as a result of any holding over beyond 15 days following the termination or expiration of this Lease. Tenant agrees that any proceedings necessary to recover possession of the Premises, whether before or after expiration of the Lease Term, shall be considered an action to enforce the terms of this Lease for purposes of the awarding of any attorney's fees in connection therewith.
  • ESTOPPEL CERTIFICATES; FINANCIAL STATEMENTS
  • Estoppel Certificates. Within ten (10) business days following a request in writing by Landlord, Tenant shall execute, acknowledge and deliver to Landlord an estoppel certificate, which, as submitted by Landlord, shall be substantially in the form of Exhibit D, attached hereto (or such other commercially reasonable form as may be required by any prospective mortgagee or purchaser of the Project, or any portion thereof), indicating therein any exceptions thereto that may exist at that time, and shall also contain any other factual information reasonably requested by Landlord or Landlord's mortgagee or prospective mortgagee. Any such certificate may be relied upon by any prospective mortgagee or purchaser of all or any portion of the Project. Tenant shall execute and deliver whatever other commercially reasonable instruments may be reasonably required for such purposes. Failure of Tenant to timely execute, acknowledge and deliver such estoppel certificate or other instruments shall constitute an acceptance of the Premises and an acknowledgment by Tenant that statements included in the estoppel certificate are true and correct, without exception.
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  • Financial Statements. At any time during the Lease Term (but not more than once in any calendar year (unless (i) in connection with the sale or proposed sale, or the financing/refinancing, of the Project or any portion thereof, (ii) an Event of Default by Tenant then exists, or (iii) there has been a filing of bankruptcy by Tenant), unless Tenant's financials are otherwise reasonably publicly available, Landlord may require Tenant to provide Landlord with (i) a balance sheet for the most recent quarter-end date, (ii) a statement of cash flows for the most recent quarter-end date, and (iii) an income statement for the trailing twelve (12) month period ending on the most recent month-end date (or such other reasonable and customary accounting method, consistently applied). Such financial statements shall be prepared in accordance with generally accepted accounting principles, and, if such is the normal practice of Tenant, shall be audited by an independent certified public accountant (or, if not so audited, the same shall be reviewed by a nationally recognized CPA firm and certified by an officer of Tenant).
  • SUBORDINATION. Landlord hereby represents and warrants to Tenant that, as of the Effective Date of this Lease, the Project is not currently subject to any ground lease, or to the lien of any mortgage or deed of trust. This Lease shall be subject and subordinate to all present and future ground or underlying leases of the Building or Project and to the lien of any mortgage, trust deed or other encumbrances now or hereafter in force against the Building or Project or any part thereof, if any (herein, a "Mortgage"), and to all renewals, extensions, modifications, consolidations and replacements thereof, and to all advances made or hereafter to be made upon the security of such Mortgage, unless the holders of any Mortgage (each, a "Mortgagee"), or the lessors under such ground lease or underlying leases, require in writing that this Lease be superior thereto. Tenant covenants and agrees in the event any proceedings are brought for the foreclosure of any such Mortgage thereof (or if any ground lease is terminated), to attorn, without any deductions or set-offs whatsoever, to the lienholder or purchaser or any successors thereto upon any such foreclosure sale or deed in lieu thereof (or to the ground lessor), if so requested to do so by such purchaser or lienholder or ground lessor, and to recognize such purchaser or lienholder or ground lessor as the lessor under this Lease, provided such lienholder or purchaser or ground lessor shall agree to accept this Lease and not disturb Tenant's occupancy, so long as Tenant timely pays Rent and observes and performs the terms, covenants and conditions of this Lease to be observed and performed by Tenant. Landlord's interest herein may be assigned as security at any time to any lienholder. Tenant shall, within ten (10) business days of request by Landlord, execute such further commercially reasonable instruments or assurances as Landlord may reasonably deem necessary to evidence or confirm the subordination or superiority of this Lease to any such mortgages, trust deeds, ground leases or underlying leases. Tenant waives the provisions of any current or future statute, rule or law which may give or purport to give Tenant any right or election to terminate or otherwise adversely affect this Lease and the obligations of the Tenant hereunder in the event of any foreclosure proceeding or sale. Notwithstanding any contrary provision in this Article 18, a condition precedent to the subordination of this Lease to any future ground or underlying lease or to the lien of any future Mortgage is that Landlord shall obtain for the benefit of Tenant a commercially reasonable subordination, non-disturbance and attornment agreement in recordable form ("Future SNDA") from the Mortgagee under such future Mortgage or the lessor under such future lease on such Mortgagee's or lessor's commercially reasonable standard form, to the effect that no steps or proceedings taken by reason of Landlord's default under such future Mortgage or lease shall terminate or materially modify this Lease, nor shall Tenant be named a defendant in any proceedings for foreclosure of such Mortgage or termination of any such lease, nor be disturbed by virtue of such step or proceedings, as long as there shall be no uncured default (beyond applicable notice and cure periods) by Tenant under this Lease. Should any current or prospective Mortgagee require a modification of this Lease, which modification will not cause an increased cost or expense to Tenant or in any other way materially and adversely change the rights and obligations of Tenant hereunder, then and in such event, this Lease may be so modified and Tenant shall execute whatever commercially reasonable documents are reasonably required therefor and to deliver the same to Landlord within ten (10) business days following a request therefor.
  • DEFAULTS; REMEDIES
  • Events of Default. In addition to any other Events of Default specified elsewhere in this Lease, the occurrence of any of the following shall constitute a default of this Lease by Tenant (each, an "Event of Default"):
  • Any failure by Tenant to pay any Rent or any other charge required to be paid under this Lease, or any part thereof, which failure continues for a period of five (5) business days following written notice from Landlord that the same is past due; or
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  • To the extent permitted by Applicable Laws, (i) Tenant or any guarantor of this Lease being placed into receivership or conservatorship, or becoming subject to similar proceedings under Federal or State law, or (ii) a general assignment by Tenant or any guarantor of this Lease for the benefit of creditors, or (iii) the taking of any material corporate action unequivocally in furtherance of bankruptcy or dissolution whether or not there exists any proceeding under an insolvency or bankruptcy law, or (iv) the filing by or against Tenant or any guarantor of any proceeding under an insolvency or bankruptcy law, unless in the case of such a proceeding filed against Tenant or any guarantor the same is dismissed within sixty (60) days, or (v) the appointment of a trustee or receiver to take possession of all or substantially all of the assets of Tenant or any guarantor, unless possession is restored to Tenant or such guarantor within thirty (30) days, or (vi) any execution or other judicially authorized seizure of all or substantially all of Tenant's assets located upon the Premises or of Tenant's interest in this Lease, unless such seizure is discharged within thirty (30) days; or
  • Abandonment (as defined by California Civil Code Section 1951.35 or any successor statute) or vacation of all or a substantial portion of the Premises by Tenant; notwithstanding anything to the contrary contained herein, Tenant shall not be deemed to have abandoned the Premises if Tenant provides Landlord with reasonable advance notice prior to vacating and, at the time of vacating the Premises, (i) Tenant has made reasonable arrangements with Landlord for the security of the Premises for the balance of the Lease Term, and (ii) Tenant continues during the balance of the Lease Term to satisfy and perform all of Tenant's obligations under this Lease as they come due; or
  • The failure by Tenant to observe or perform according to the provisions of Articles 5, 14, 17 or 18 of this Lease or any provision of the Tenant Work Letter, where, in each instance, such failure continues for more than five (5) business days after notice from Landlord; or
  • intentionally omitted; or
  • Except where a specific time period for Tenant's performance is otherwise expressly set forth in this Lease, in which event the failure to perform by Tenant within such time period shall be an Event of Default by Tenant under this Section 19.1.6, any failure by Tenant to observe or perform any other provision, covenant or condition of this Lease to be observed or performed by Tenant where such failure continues for thirty (30) days after written notice thereof from Landlord to Tenant; provided that if the nature of such default is such that the same cannot reasonably be cured within a thirty (30) day period (or, as applicable, within the specific time period for Tenant's performance otherwise expressly set forth in this Lease), no Event of Default shall be deemed to have occurred under this Section 19.1.6 if Tenant diligently commences such cure within such period and thereafter diligently proceeds to rectify and cure such default, but in no event exceeding a period of time in excess of one hundred twenty (120) days after written notice from Landlord to Tenant.

Any notices to be provided by Landlord under this Section 19.1 shall be in lieu of, and not in addition to, any notice required under Section 1161 et seq. of the Code of Civil Procedure, and may be served on Tenant in the manner allowed for service of notices under this Lease.

  • Remedies Upon Event of Default. Upon the occurrence of any Event of Default by Tenant, Landlord shall have, in addition to any other remedies available to Landlord at law or in equity (all of which remedies shall be distinct, separate and cumulative), the option to pursue any one or more of the following remedies (including, without limitation, during any eviction moratorium, to the extent not prohibited by Applicable Law), each and all of which shall be cumulative and nonexclusive, without any notice or demand whatsoever.
  • Terminate this Lease, in which event Tenant shall immediately surrender the Premises to Landlord, and if Tenant fails to do so, Landlord may, without prejudice to any other remedy which it may have for possession or arrearages in rent, enter upon and take possession of the Premises and expel or remove Tenant and any other person who may be occupying the Premises or any part thereof, without being liable for prosecution or for any claim for damages therefor; and Landlord may recover from Tenant the following:
  • The worth at the time of award of any unpaid rent which has been earned at the time of such termination; plus
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  • The worth at the time of award of the amount by which the unpaid rent which would have been earned after termination until the time of award exceeds the amount of such rental loss that Tenant proves could have been reasonably avoided; plus
  • The worth at the time of award of the amount by which the unpaid rent for the balance of the Lease Term after the time of award exceeds the amount of such rental loss that Tenant proves could have been reasonably avoided; plus
  • Any other amount reasonably necessary to compensate Landlord for all the detriment proximately caused by Tenant's failure to perform its obligations under this Lease or which in the ordinary course of things would be likely to result therefrom, specifically including but not limited to, brokerage commissions and advertising expenses incurred, expenses of remodeling the Premises or any portion thereof for a new tenant, whether for the same or a different use; and
  • At Landlord's election, such other amounts in addition to or in lieu of the foregoing as may be permitted from time to time by Applicable Laws.

The term "rent" as used in this Section 19.2 shall be deemed to be and to mean all sums of every nature required to be paid by Tenant pursuant to the terms of this Lease, whether to Landlord or to others. As used in Sections 19.2.1(i) and (ii), above, the "worth at the time of award" shall be computed by allowing interest at the Interest Rate. As used in Section 19.2.1(iii) above, the "worth at the time of award" shall be computed by discounting such amount at the discount rate of the Federal Reserve Bank of San Francisco at the time of award plus one percent (1%).

  • Landlord shall have the remedy described in California Civil Code Section 1951.4 (lessor may continue lease in effect after lessee's breach and abandonment and recover rent as it becomes due, if lessee has the right to sublet or assign, subject only to reasonable limitations). Accordingly, if Landlord does not elect to terminate this Lease on account of any Event of Default by Tenant, Landlord may, from time to time, without terminating this Lease, enforce all of its rights and remedies under this Lease, including the right to recover all rent as it becomes due.
  • Any agreement for free, abated, or reduced Rent or other charges (including, without limitation, the Base Rent Abatement, the Tenant Improvement Allowance, the Additional TI Allowance Payment (as defined in the Tenant Work Letter attached hereto and incorporated herein by reference)), any other allowances or other rights of reimbursement granted to Tenant (for improvements, furniture, fixtures, equipment, moving costs, or otherwise), any other agreement for the giving or paying by Landlord to or for the benefit of Tenant of any monetary amounts, and any other bonus, inducement, or other consideration for Tenant entering into this Lease, all of which concessions are hereinafter referred to as "Inducement Provisions" shall be deemed conditioned upon Tenant's full and faithful performance of all of the terms and conditions of this Lease. Accordingly, upon the occurrence of any Event of Default, if this Lease is terminated, in addition to all other rights and remedies of Landlord, at Landlord's sole option (which may be exercised by Landlord at any time following the occurrence of any Event of Default), any and all of the Inducement Provisions (as may be designated by Landlord) shall be deemed null and void and of no further force or effect, and any Rent, other charge, bonus, inducement, consideration, or other amount therefore abated, reduced, given or paid by Landlord under such Inducement Provision(s) shall be immediately due and payable by Tenant to Landlord. Alternatively, with respect to any Inducement Provision that is in the nature of an agreement for free, abated, or reduced Rent or other charges (including, without limitation, the Base Rent Abatement, the Tenant Improvement Allowance, and any Additional TI Allowance), Landlord shall have the right, in its sole and absolute discretion, to cause the dollar amount of the unapplied portion of any such Inducement Provision as of the Event of Default or termination, as the case may be, to be converted to a credit to be applied to the Base Rent applicable at the end of the Lease Term, in which event Tenant shall immediately be obligated to begin paying Base Rent for the Premises in full (without regard to the applicable Inducement Provision). The acceptance by Landlord of Rent or the cure of any Event of Default shall not be deemed a waiver by Landlord of its rights under this Section 19.2.3.
  • Landlord shall at all times have the rights and remedies (which shall be cumulative with each other and cumulative and in addition to those rights and remedies available under Sections 19.2.1, 19.2.2, and 19.2.3 above, or any law or other provision of this Lease), without prior demand or notice except as required by
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  • Applicable Laws, to seek any declaratory, injunctive or other equitable relief, and specifically enforce this Lease, or restrain or enjoin a violation or breach of any provision hereof.
  • Subleases of Tenant. Whether or not Landlord elects to terminate this Lease on account of any Event of Default, Landlord shall have the right to terminate any and all subleases, licenses, concessions or other consensual arrangements for possession entered into by Tenant and affecting the Premises or may, in Landlord's sole discretion, succeed to Tenant's interest in such subleases, licenses, concessions or arrangements. In the event of Landlord's election to succeed to Tenant's interest in any such subleases, licenses, concessions or arrangements, Tenant shall, as of the date of notice by Landlord of such election, have no further right to or interest in the rent or other consideration receivable thereunder.
  • Efforts to Relet. No re-entry or repossession, repairs, maintenance, changes, alterations and additions, reletting, appointment of a receiver to protect Landlord's interests hereunder, or any other action or omission by Landlord shall be construed as an election by Landlord to terminate this Lease or Tenant's right to possession, or to accept a surrender of the Premises, nor shall same operate to release Tenant in whole or in part from any of Tenant's obligations hereunder, unless express written notice of such intention is sent by Landlord to Tenant. Tenant hereby irrevocably waives any right otherwise available under any law to redeem or reinstate this Lease.
  • Landlord Default. Landlord shall be in default under this Lease only if Landlord fails to perform any of its obligations hereunder and such failure continues for thirty (30) days after Tenant delivers to Landlord written notice specifying such failure; however, if such failure cannot reasonably be cured within such 30-day period, but Landlord commences to cure such failure within such 30-day period and thereafter diligently pursues the curing thereof to completion, then Landlord shall not be in default hereunder or liable for damages therefor. Except where the provisions of this Lease grant Tenant an express, exclusive remedy, or expressly deny Tenant a remedy, Tenant's exclusive remedy for Landlord's default under this Lease shall be limited to Tenant's actual direct, but not consequential, damages caused by such default; in each case, Landlord's liability or obligations with respect to any such remedy shall be limited as provided in Section 30.10 below. All obligations of Landlord under this Lease shall be construed as covenants, not conditions. Except as expressly set forth herein, Tenant hereby waives the benefit of any laws granting it the right to perform Landlord's obligations or the right to terminate this Lease or withhold Rent on account of any Landlord default. Notwithstanding anything to the contrary set forth in this Lease, neither Landlord nor the Landlord Parties shall be liable under any circumstances for injury or damage to, or interference with, Tenant's business, including but not limited to, loss of profits, loss of rents or other revenues, loss of business opportunity, loss of goodwill or loss of use, or any indirect, consequential, or punitive damages or any kind, in each case, however occurring.
  • Abatement Event. In the event that Tenant is prevented from using, and does not use the Premises, as a result of (i) any repair, maintenance or alteration performed by Landlord, or which Landlord failed to perform, after the Lease Commencement Date and required by this Lease, or (ii) any failure to provide utility connections to the Building or the Project or access to the Premises as required by this Lease, each as a direct result of Landlord's gross negligence or willful misconduct (and except to the extent such failure is caused by the action or inaction of Tenant or is outside of Landlord’s ability to cure), Tenant shall give Landlord notice (the "Initial Notice"), specifying such failure to perform by Landlord (the "Abatement Event"). If Landlord has not cured such Abatement Event within five (5) business days after the receipt of the Initial Notice, Tenant may deliver an additional notice to Landlord (the "Additional Notice"), specifying such Abatement Event and Tenant's intention to abate the payment of Rent under this Lease. If Landlord does not cure such Abatement Event within two (2) business days of receipt of the Additional Notice, Tenant may, upon written notice to Landlord, immediately abate Rent payable under this Lease for that portion of the Premises rendered untenantable and not used by Tenant for the operation of its business, for the period beginning on the date after the Initial Notice to the earlier of the date Landlord cures such Abatement Event or the date Tenant recommences the use of such portion of the Premises. Such right to abate Rent shall be Tenant's sole and exclusive remedy at law or in equity for an Abatement Event. Except as provided in this Section 19.6, nothing contained herein shall be interpreted to mean that Tenant is excused from paying Rent due hereunder.
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  • COVENANT OF QUIET ENJOYMENT. Landlord covenants that Tenant, on paying the Rent, charges for services and other payments herein reserved and on keeping, observing and performing all the other terms, covenants, conditions, provisions and agreements herein contained on the part of Tenant to be kept, observed and performed, shall, during the Lease Term, peaceably and quietly have, hold and enjoy the Premises subject to the terms, covenants, conditions, provisions and agreements hereof without interference by any persons lawfully claiming by or through Landlord. The foregoing covenant is in lieu of any other covenant express or implied.
  • SECURITY DEPOSIT. Concurrently with Tenant's execution of this Lease, Tenant shall deposit with Landlord a security deposit (the "Security Deposit") in the amount set forth in Section 8 of the Summary, as security for the faithful performance by Tenant of all of its obligations under this Lease. If Tenant defaults with respect to any provisions of this Lease beyond applicable notice and cure periods, including, but not limited to, the provisions relating to the payment of Rent, or the removal requirements in Article 15, Landlord may, without notice to Tenant, but shall not be required to, apply all or any part of the Security Deposit for the payment of any Rent or any other sum in default. Tenant shall, within ten (10) business days of demand therefor, restore the Security Deposit to its original amount (including, without limitation, during any eviction moratorium, to the extent allowed by Applicable Laws). Tenant's failure to timely restore the Security Deposit to its original amount shall constitute an Event of Default under this Lease with no requirement for any additional notice or cure period. The Security Deposit is not an advance payment of Rent or a measure or limit of Landlord's damages upon an Event of Default. Any unapplied portion of the Security Deposit shall be returned to Tenant, or, at Landlord's option, to the last assignee of Tenant's interest hereunder, within forty-five (45) days following the expiration of the Lease Term. Tenant shall not be entitled to any interest on the Security Deposit. Tenant hereby irrevocably waives and relinquishes any and all rights, benefits, or protections, if any, Tenant now has, or in the future may have, under Section 1950.7 of the California Civil Code, any successor statute, and all other provisions of law, now or hereafter in effect, including, but not limited to, any provision of law which (i) establishes the time frame by which a landlord must refund a security deposit under a lease, or (ii) provides that a landlord may claim from a security deposit only those sums reasonably necessary to remedy defaults in the payment of rent, to repair damage caused by a tenant, or to clean the subject premises. Tenant acknowledges and agrees that (a) any statutory time frames for the return of a security deposit are superseded by the express period identified in this Article 21, above, and (b) rather than be so limited, Landlord may claim from the Security Deposit (1) any and all sums expressly identified in this Article 21, above, and (2) any additional sums reasonably necessary to compensate Landlord for any and all losses or damages caused by Tenant's default of this Lease beyond applicable notice and cure periods, including, but not limited to, all damages or rent due upon termination of this Lease pursuant to Section 1951.2 of the California Civil Code.
  • COMMUNICATIONS AND COMPUTER LINES. Tenant may install, maintain, replace, remove or use any communications or computer wires and cables serving the Premises (collectively, the "Lines"), provided that Tenant shall obtain Landlord's prior written consent, not to be unreasonably withheld, conditioned, or delayed, use an experienced and qualified contractor approved in writing by Landlord, such approval not to be unreasonably withheld, conditioned, or delayed and comply with all of the other provisions of Articles 7 and 8 of this Lease. Tenant shall pay all costs in connection therewith. Notwithstanding anything in this Lease to the contrary, Tenant shall have no obligation to remove any Lines located in or serving the Premises prior to the expiration or earlier termination of this Lease, provided, that, Tenant shall cause the same to be clearly labeled and neatly bundled.
  • SIGNS
  • Exterior Signage. Subject to Landlord's prior written approval, which shall not be unreasonably withheld, conditioned or delayed, and provided all signs are in keeping with the quality, design and style of the Building and Project, the Building's signage program (if applicable), and comply with the Underlying Documents and all Applicable Laws, including, but not limited to, the City of San Diego's municipal code, Tenant, at its sole cost and expense, may install (i) one (1) panel on one side of the existing monument sign serving the Building, (ii) signage in the lobby directory, (iii) suite entry signage at the entry of Tenant's suite, and (iv) one (1) backlit sign on the freeway facing side of the Building (in a location mutually agreed upon by Landlord and Tenant) (collectively, "Tenant Signage"); provided, however, in no event shall Tenant's Signage include an "Objectionable Name," as that term is defined in Section 23.2, of this Lease. All such signage shall be subject to Tenant's obtaining all required governmental approvals. All permitted signs shall be maintained by Tenant at its expense in a first-class and safe condition and appearance. Upon the expiration or earlier termination of this Lease, Tenant shall remove all of its signs at Tenant's sole cost and expense. The graphics, materials, color, design, lettering, lighting, size, illumination, specifications and
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  • exact location of Tenant's Signage (collectively, the "Sign Specifications") shall be subject to the prior written approval of Landlord, which approval shall not be unreasonably withheld or delayed, and shall be consistent and compatible with the quality and nature of the Project. Tenant hereby acknowledges that, notwithstanding Landlord's approval of Tenant's Signage, Landlord has made no representation or warranty to Tenant with respect to the probability of obtaining all necessary governmental approvals and permits (along with any approvals required under the Underlying Documents) for Tenant's Signage. In the event Tenant does not receive the necessary governmental approvals and permits (along with any approvals required under the Underlying Documents) for Tenant's Signage, Tenant's and Landlord's rights and obligations under the remaining TCCs of this Lease shall be unaffected.
  • Objectionable Name. Tenant's Signage shall not include a name or logo which relates to an entity which is of a character or reputation, or is associated with a political faction or orientation, which is inconsistent with the quality of the Project, or which would otherwise reasonably offend a landlord of the Comparable Buildings (an "Objectionable Name"). The parties hereby agree that the following name, or any reasonable derivation thereof, shall be deemed not to constitute an Objectionable Name: "Kura Oncology."
  • Prohibited Signage and Other Items. Any signs, notices, logos, pictures, names or advertisements which are installed and that have not been separately approved by Landlord may be removed without notice by Landlord at the sole expense of Tenant. Tenant may not install any signs on the exterior or roof of the Project or in any Common Areas. Any signs, window coverings, or blinds (even if the same are located behind the Landlord-approved window coverings for the Building), or other items visible from the exterior of the Premises or Building, shall be subject to the prior approval of Landlord, in its sole but reasonable discretion.
  • Termination of Right to Tenant's Signage. The rights contained in this Article 23 shall be personal to Original Tenant and its Permitted Assignee, and may only be exercised and maintained by such parties (and not any other assignee, sublessee or other transferee of the Original Tenant's interest in this Lease) to the extent such party (x) is not in default under this Lease (beyond any applicable notice and cure period) and (y) (with respect to the signage identified in Sections 23.1(i) and (iv) only) occupies the entire Premises.
  • COMPLIANCE WITH LAW. Tenant shall not do anything or suffer anything to be done in or about the Premises or the Project which will in any way conflict with any law, statute, ordinance or other rule, directive, order, regulation, guideline or requirement of any governmental entity or governmental agency now in force or which may hereafter be enacted or promulgated (collectively, "Applicable Laws"). At its sole cost and expense, Tenant shall promptly comply with all Applicable Laws (including the making of any alterations to the Premises required by Applicable Laws) which relate to (i) Tenant's use of, or requirements to cease or reduce Tenant's business operations in or Tenant's use of, the Premises, (ii) Tenant's repair obligations as set forth in Section 7.1, and (iii) Tenant's personal property. Notwithstanding anything contained herein to the contrary, Landlord agrees, as and when required by Applicable Laws, to be responsible for causing the Premises, Base Building, or Building Systems to comply with Applicable Laws existing as of the Possession Date but only to the extent required to obtain a certificate of occupancy for the Premises; provided, however, to the extent Landlord is required to incur any such costs as a result of Tenant's specific use of the Premises, or as a result of any alterations to the Premises made by or on behalf of Tenant (including, without limitation, any Alterations or Tenant Improvements), Tenant agrees to promptly reimburse Landlord for the same within thirty (30) days following receipt of an invoice therefor. Should any standard or regulation now or hereafter be imposed on Landlord or Tenant by a state, federal or local governmental body charged with the establishment, regulation and enforcement of occupational, health or safety standards for employers, employees, landlords or tenants, then Tenant shall, at its sole cost and expense, comply promptly with such standards or regulations. The judgment of any court of competent jurisdiction or the admission of Tenant in any judicial action, regardless of whether Landlord is a party thereto, that Tenant has violated any of said governmental measures, shall be conclusive of that fact as between Landlord and Tenant. For purposes of Section 1938 of the California Civil Code, Landlord hereby discloses to Tenant, and Tenant hereby acknowledges, that the Project, Building and Premises have not undergone inspection by a Certified Access Specialist (CASp). As required by Section 1938(e) of the California Civil Code, Landlord hereby states as follows: "A Certified Access Specialist (CASp) can inspect the subject premises and determine whether the subject premises comply with all of the applicable construction-related accessibility standards under state law. Although state law does not require a CASp inspection of the subject premises, the commercial property owner or lessor may not prohibit the lessee or tenant from obtaining a CASp inspection of the subject premises for the occupancy or potential occupancy of the lessee or tenant, if requested by the lessee or tenant. The parties shall mutually agree on the arrangements for the time and manner of the CASp inspection, the payment of
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  • the fee for the CASp inspection, and the cost of making any repairs necessary to correct violations of construction-related accessibility standards within the premises." In furtherance of the foregoing, Landlord and Tenant hereby agree as follows: (a) any CASp inspection requested by Tenant shall be conducted, at Tenant's sole cost and expense, by a CASp approved in advance by Landlord; and (b) pursuant to Article 24 below, Tenant, at its cost, is responsible for making any repairs within the Premises to correct violations of construction-related accessibility standards; and, if anything done by or for Tenant in its use or occupancy of the Premises shall require repairs to the Building (outside the Premises) to correct violations of construction-related accessibility standards, then Tenant shall, at Landlord's option, either perform such repairs at Tenant's sole cost and expense or reimburse Landlord upon demand, as Additional Rent, for the cost to Landlord of performing such repairs.
  • LATE CHARGES. If any installment of Rent or any other sum due from Tenant shall not be received by Landlord or Landlord's designee when due, then Tenant shall pay to Landlord a late charge equal to five percent (5%) of the overdue amount plus any actual and reasonable attorneys' fees incurred by Landlord by reason of Tenant's failure to pay such amounts when due; provided, however, with regard to the first such failure in any twelve (12) month period, Landlord will waive such late charge to the extent Tenant cures such failure within five (5) business days following Tenant's receipt of written notice from Landlord that the same was not received when due. The parties agree that such late charge represents a fair and reasonable estimate of the costs that Landlord will incur by reason of such late payment by Tenant. The late charge shall be deemed Additional Rent and the right to require it shall be in addition to all of Landlord's other rights and remedies hereunder or at law and shall not be construed as limiting Landlord's remedies in any manner. In addition to the late charge described above, any Rent or other amounts owing hereunder which are not paid within ten (10) business days after the date they are due shall bear interest from the date when due until paid at an annual interest rate (the "Interest Rate") equal to the lesser of (i) the annual "Bank Prime Loan" rate cited in the Federal Reserve Statistical Release Publication H.15(519), published weekly (or such other comparable index as Landlord and Tenant shall reasonably agree upon if such rate ceases to be published), plus four (4) percentage points, and (ii) the highest rate permitted by Applicable Laws.
  • LANDLORD'S RIGHT TO CURE DEFAULT; PAYMENTS BY TENANT
  • Landlord's Cure. All covenants and agreements to be kept or performed by Tenant under this Lease shall be performed by Tenant at Tenant's sole cost and expense and without any reduction of Rent, except to the extent, if any, otherwise expressly provided herein. If Tenant shall fail to perform any obligation under this Lease, and such failure shall continue in excess of the time allowed under Section 19.1.6, above, unless a specific time period is otherwise stated in this Lease, Landlord may, but shall not be obligated to, make any such payment or perform any such act on Tenant's part without waiving its rights based upon any such Event of Default of Tenant and without releasing Tenant from any obligations hereunder. Landlord shall have the right to apply payments received from Tenant pursuant to this Lease, regardless of Tenant's designation of such payments, to satisfy any obligations of Tenant hereunder, in such order and amounts as Landlord, in its sole discretion, may elect.
  • Tenant's Reimbursement. Except as may be specifically provided to the contrary in this Lease, Tenant shall pay to Landlord, within thirty (30) days of delivery by Landlord to Tenant of statements therefor: (i) sums equal to expenditures reasonably made and obligations incurred by Landlord in connection with the remedying by Landlord of Tenant's defaults beyond applicable notice and cure periods pursuant to the provisions of Section 26.1; (ii) sums equal to all Losses referred to in Article 10 of this Lease; and (iii) sums equal to all actual and reasonable expenditures made and obligations incurred by Landlord in collecting or attempting to collect past-due Rent or in enforcing or attempting to enforce any rights of Landlord under this Lease or pursuant to law, including, without limitation, all reasonable attorneys' fees, legal costs, and other amounts so expended. Tenant's obligations under this Section 26.2 shall survive the expiration or earlier termination of the Lease Term.
  • ENTRY BY LANDLORD. Landlord reserves the right at all reasonable times and upon at least twenty-four (24) hours prior written notice to Tenant (except in the case of an emergency, in which case no prior notice is required) to enter the Premises to (i) inspect them; (ii) show the Premises to prospective purchasers, or to current or prospective Mortgagees or insurers, or during the last twelve (12) months of the Lease Term (or at any time during which a monetary or material non-monetary Event of Default is continuing under this Lease), to prospective tenants; (iii) post notices of non-responsibility; or (iv) perform Landlord's Repair Obligations. Landlord shall use commercially reasonable efforts to schedule entries into the Premises under this Section 27 with Tenant (except if not reasonably practicable in emergencies) so that Tenant, at Tenant's option, may provide an employee or a representative
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  • of Tenant to accompany Landlord. Notwithstanding anything to the contrary contained in this Article 27, Landlord may enter the Premises at any time without notice to (a) perform any services required of Landlord, provided Landlord shall provide at least twenty-four (24) hours prior written notice to Tenant (except in the case of an emergency, in which case no prior notice is required) if Landlord is attending to its maintenance or repair obligations under this Lease; (b) take possession due to any Event of Default under this Lease in the manner provided herein; and (c) perform any covenants of Tenant which Tenant fails to perform within applicable notice and cure periods. Landlord may make any such entries without the abatement of Rent, except as otherwise provided in this Lease, and may take such reasonable steps as required to accomplish the stated purposes; provided, however, any such entry (other than under (b) above) shall be performed in a manner so as not to unreasonably interfere with Tenant's use of the Premises and, except for (x) emergencies, or (y) repairs, alterations, improvements or additions required by Applicable Laws, shall be performed after normal business hours if reasonably practical. Except for any injury to persons or damage to property (but not loss of or interference with business, use or profits or other consequential or indirect damages or punitive damages) to the extent caused by Landlord's gross negligence or intentional misconduct, Tenant hereby waives any Losses for any injuries or inconvenience to or interference with Tenant's business, lost profits, any loss of occupancy or quiet enjoyment of the Premises, and any other loss occasioned by such entries. For each of the above purposes, Landlord shall at all times have a key with which to unlock all the doors in the Premises, excluding Tenant's vaults, safes and special security areas designated in advance by Tenant. In an emergency, Landlord shall have the right to use any means that Landlord may deem proper to open the doors in and to the Premises. Any entry into the Premises by Landlord in the manner hereinbefore described shall not be deemed to be a forcible or unlawful entry into, or a detainer of, the Premises, or an actual or constructive eviction of Tenant from any portion of the Premises. In connection with any such entry by Landlord, Landlord shall use all commercially reasonable and good faith efforts to comply with Tenant's commercially reasonable security measures in effect from time to time.
  • TENANT PARKING. Tenant shall have the right throughout the initial Lease Term and the Option Term, if the Extension Option is exercised pursuant to Section 2.2 above, to use, free of charge, for the parking of vehicles, the amount of parking set forth in Section 9 of the Summary, in the on-site and/or off-site, as the case may be, parking facility (or facilities) which serve the Project, with Tenant's initial reserved parking spaces located in the areas designated on Exhibit G attached hereto; provided, however, Landlord shall have the right to reconfigure and/or relocate such reserved parking spaces throughout the Lease Term in Landlord's sole, but reasonable, discretion so long as Landlord delivers no less than ten (10) business days' advance notice thereof to Tenant and Landlord does not reduce the number of such reserved parking spaces available to Tenant under this Lease. Tenant shall abide by all reasonable, non-discriminatory rules and regulations which are prescribed from time to time and provided to Tenant in writing for the orderly operation and use of the parking facility where the parking spaces are located (including any sticker or other identification system established by Landlord and the prohibition of vehicle repair and maintenance activities in the parking facilities), and shall cooperate in seeing that Tenant's employees and visitors also comply with such rules and regulations. Tenant's use of the Project parking facility shall be at Tenant's sole risk and Tenant acknowledges and agrees that Landlord shall have no liability whatsoever for damage to the vehicles of Tenant, its employees and/or visitors, or for other personal injury or property damage or theft relating to or connected with the parking rights granted herein or any of Tenant's, its employees' and/or visitors' use of the parking facilities. Notwithstanding the foregoing, in the event Landlord voluntarily (i.e., not in connection with construction, alterations or improvements required due to compliance with Applicable Laws, or due to a Casualty) closes off or restricts access to such parking facility (or facilities) serving the Project for more than five (5) business days which results in a decrease in Tenant’s Parking Allotment or if such decrease in Tenant’s Parking Allotment is a result of Landlord’s gross negligence, Landlord shall provide reasonably convenient and commercially reasonable alternative parking for Tenant’s use at no charge to Tenant, such that if, for example, twenty (20) parking spaces are closed off or restricted by Landlord, then Landlord shall provide twenty (20) alternate parking spaces to Tenant. For purposes of the foregoing sentence, Tenant agrees that any alternative parking spaces located at Director's Place shall be deemed reasonably convenient and commercially reasonable alternative parking.
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  • MISCELLANEOUS PROVISIONS
  • Terms; Captions. The words "Landlord" and "Tenant" as used herein shall include the plural as well as the singular. The necessary grammatical changes required to make the provisions hereof apply either to corporations or partnerships or individuals, men or women, as the case may require, shall in all cases be assumed as though in each case fully expressed. The captions of Articles and Sections are for convenience only and shall not be deemed to limit, construe, affect or alter the meaning of such Articles and Sections.
  • Binding Effect. Subject to all other provisions of this Lease, each of the covenants, conditions and provisions of this Lease shall extend to and shall, as the case may require, bind or inure to the benefit not only of Landlord and of Tenant, but also of their respective heirs, personal representatives, successors or assigns, provided this clause shall not permit any assignment by Tenant contrary to the provisions of Article 14 of this Lease.
  • No Air Rights. No rights to any view or to light or air over any property, whether belonging to Landlord or any other person, are granted to Tenant by this Lease. If at any time any windows of the Premises are temporarily darkened or the light or view therefrom is obstructed by reason of any repairs, improvements, maintenance or cleaning in or about the Project, the same shall be without liability to Landlord and without any reduction or diminution of Tenant's obligations under this Lease.
  • Modification of Lease. Should any current or prospective mortgagee or ground lessor for the Building or Project require a modification of this Lease, which modification will not cause an increased cost or expense to Tenant or in any other way materially and adversely change the rights and obligations of Tenant hereunder, then and in such event, Tenant agrees that this Lease may be so modified and agrees to execute whatever commercially reasonable documents are reasonably required therefor and to deliver the same to Landlord within ten (10) business days following a request therefor. At the request of Landlord or any mortgagee or ground lessor, Tenant agrees to execute a short form of Lease and deliver the same to Landlord within ten (10) business days following the request therefor.
  • Transfer of Landlord's Interest. Landlord has the right to transfer all or any portion of its interest in the Project or Building and in this Lease, and in the event of any such transfer, (i) Landlord shall automatically be released from all liability under this Lease accruing from and after the date of such transfer, (ii) Tenant shall look solely to such transferee for the performance of Landlord's obligations hereunder after the date of transfer, (iii) such transferee shall be deemed to have fully assumed and be liable for all obligations of this Lease to be performed by Landlord, including the return of any Security Deposit, and (iv) Tenant shall attorn to such transferee. Landlord may also assign its interest in this Lease to a mortgagee as additional security, but such an assignment shall not release Landlord from its obligations hereunder and Tenant shall continue to look to Landlord for the performance of its obligations hereunder.
  • Prohibition Against Recording. Except as provided in Section 29.4 of this Lease, neither this Lease, nor any memorandum, affidavit or other writing with respect thereto, shall be recorded by Tenant or by anyone acting through, under or on behalf of Tenant.
  • Landlord's Title. Landlord's title is and always shall be paramount to the title of Tenant. Nothing herein contained shall empower Tenant to do any act which can, shall or may encumber the title of Landlord.
  • Relationship of Parties. Nothing contained in this Lease shall be deemed or construed by the parties hereto or by any third party to create the relationship of principal and agent, partnership, joint venture or any association between Landlord and Tenant.
  • Material Adverse Judgments. If Tenant is an entity that is domiciled in the United States of America, and whose securities are funded through a public securities exchange subject to regulation by the United States of America publicly traded over exchanges based in the United States and whose financial statements are readily available at no cost to Landlord, the terms of this Section 29.9 shall not apply. Tenant hereby represents and warrants that as of the Effective Date, (i) there are no actions pending against Tenant under the bankruptcy or similar laws of the United States or any state; and (ii) there are no actions pending against Tenant that, if determined or adjudicated
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  • adversely to Tenant, could materially impair Tenant's ability to perform its obligations under this Lease ("Material Adverse Judgments"). During the Lease Term, if any Material Adverse Judgment is made or entered against Tenant, Tenant shall promptly notify Landlord of such Material Adverse Judgment in writing with reasonably sufficient detail.
  • Time of Essence. Time is of the essence with respect to the performance of every provision of this Lease in which time of performance is a factor.
  • Partial Invalidity. If any term, provision or condition contained in this Lease shall, to any extent, be invalid or unenforceable, the remainder of this Lease, or the application of such term, provision or condition to persons or circumstances other than those with respect to which it is invalid or unenforceable, shall not be affected thereby, and each and every other term, provision and condition of this Lease shall be valid and enforceable to the fullest extent possible permitted by law.
  • No Warranty. In executing and delivering this Lease, Tenant has not relied on any representations, including, but not limited to, any representation as to the amount of any item included in Direct Expenses or the amount of Direct Expenses in the aggregate or that Landlord is furnishing the same services to other tenants, at all, on the same level or on the same basis, or any warranty or any statement of Landlord which is not set forth herein or in one or more of the exhibits attached hereto.
  • Landlord Exculpation. The liability of Landlord or the Landlord Parties to Tenant for any default by Landlord under this Lease or arising in connection herewith or with Landlord's operation, management, leasing, repair, renovation, alteration or any other matter relating to the Project or the Premises shall be limited solely and exclusively to an amount which is equal to the interest of Landlord in the Building, provided that in no event shall such liability extend to (i) any insurance proceeds received by Landlord or the Landlord Parties in connection with the Project, Building or Premises, or (ii) any proceeds from any sale of the Project, Building or Premises once such sale proceeds have been distributed to Landlord's shareholders, members, owners and/or similar ownership parties. Neither Landlord, nor any of the Landlord Parties shall have any personal liability therefor, and Tenant hereby expressly waives and releases such personal liability on behalf of itself and all persons claiming by, through or under Tenant. The limitations of liability contained in this Section 29.13 shall inure to the benefit of Landlord's and the Landlord Parties' present and future partners, beneficiaries, officers, directors, trustees, shareholders, agents and employees, and their respective partners, heirs, successors and assigns. Under no circumstances shall any present or future partner of Landlord (if Landlord is a partnership), or trustee or beneficiary (if Landlord or any partner of Landlord is a trust), have any liability for the performance of Landlord's obligations under this Lease. Notwithstanding any contrary provision herein, neither Landlord nor the Landlord Parties shall be liable under any circumstances for any indirect, consequential, or punitive damages and/or any injury or damage to, or interference with, Tenant's business, including but not limited to, loss of profits, loss of rents or other revenues, loss of business opportunity, loss of goodwill or loss of use, in each case, however occurring, or loss to inventory, scientific research, scientific experiments, laboratory animals, products, specimens, samples, and/or scientific, business, accounting and other records of every kind and description kept at the premises and any and all income derived or derivable therefrom.
  • Entire Agreement. It is understood and acknowledged that there are no oral agreements between the parties hereto affecting this Lease and this Lease constitutes the parties' entire agreement with respect to the leasing of the Premises and supersedes and cancels any and all previous negotiations, arrangements, brochures, agreements and understandings, if any, between the parties hereto (including, without limitation, any confidentiality agreement, letter of intent, request for proposal, or similar agreement previously entered into between Landlord and Tenant in anticipation of this Lease) or displayed by Landlord to Tenant with respect to the subject matter thereof, and none thereof shall be used to interpret or construe this Lease. None of the terms, covenants, conditions or provisions of this Lease can be modified, deleted or added to except in writing signed by the parties hereto.
  • Right to Lease. Landlord reserves the absolute right to effect such other tenancies in the Project as Landlord in the exercise of its sole business judgment shall determine to best promote the interests of the Building or Project. Tenant does not rely on the fact, nor does Landlord represent, that any specific tenant or type or number of tenants shall, during the Lease Term, occupy any space in the Building or Project.
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  • Force Majeure. Notwithstanding anything to the contrary contained in this Lease (but subject to the terms and conditions of this Section 29.16), any prevention, delay or stoppage due to strikes, lockouts, labor disputes, acts of God, acts of war, terrorist acts, inability to obtain services, labor, or materials or reasonable substitutes therefor, governmental actions, civil commotions, Casualty, actual or threatened public health emergency (including, without limitation, epidemic, pandemic, famine, disease, plague, quarantine, and other significant public health risk), governmental edicts, actions, declarations or quarantines by a governmental entity or health organization (including, without limitation, any shelter-in-place orders, stay at home orders or any restrictions on travel related thereto that preclude Tenant, its agents, contractors or its employees from accessing the Premises, national or regional emergency), breaches in cybersecurity, and other causes beyond the reasonable control of the party obligated to perform, regardless of whether such other causes are (i) foreseeable or unforeseeable or (ii) related to the specifically enumerated events in this Section 29.16 (collectively, a "Force Majeure"), shall excuse the performance of such party for a period of time equal to any such prevention, delay or stoppage. If this Lease specifies a time period for performance of an obligation of either party, that time period shall be extended by the period of any delay in such party's performance caused by a Force Majeure. Notwithstanding the foregoing or anything to the contrary in this Lease, in no event shall Force Majeure: (a) excuse Tenant's obligations to pay Rent and other charges due pursuant to this Lease; (b) be grounds for Tenant to abate any portion of Rent due pursuant to this Lease, or entitle either party to terminate this Lease, except as allowed pursuant to Articles 11 and 13 of this Lease; (c) excuse Tenant's obligations under Articles 5 and 24 or Section 10.3 of this Lease; (d) extend the time period for Tenant to vacate the Premises following expiration of the Lease Term; (e) excuse Tenant from paying for utilities whether to Landlord or a utility provider; or (f) extend the occurrence of the Lease Commencement Date. Without limiting the generality of the foregoing, Tenant agrees and acknowledges that (1) events of Force Majeure may limit, interfere with, or prevent Tenant for using the Premises, and from entering the Premises, (2) such potential interference, limitation, and prevention is foreseeable, and (3) no such limitations, interference or prevention shall constitute frustration of purpose, impossibility of performance, or impracticality of performance with respect to this Lease. Tenant hereby waives any and all rights it might otherwise have pursuant to Section 1511 of the California Civil Code, and hereby agrees that this Section 29.16 is an express provision to the contrary. Tenant's agreement to the terms and conditions of this Section 29.16 is material consideration for Landlord's agreement to enter into this Lease.
  • Waiver of Redemption by Tenant. Tenant hereby waives, for Tenant and for all those claiming under Tenant, any and all rights now or hereafter existing to redeem by order or judgment of any court or by any legal process or writ, Tenant's right of occupancy of the Premises after any termination of this Lease.
  • Notices. All notices, demands, statements, designations, approvals or other communications (collectively, "Notices") given or required to be given by either party to the other hereunder or by law shall be in writing, shall be (A) sent by United States certified or registered mail, postage prepaid, return receipt requested ("Mail"), (B) transmitted by telecopy, if such telecopy is promptly followed by a Notice sent by Mail, (C) delivered by a nationally recognized overnight courier, or (D) delivered personally. Any Notice shall be sent, transmitted, or delivered, as the case may be, to Tenant at the appropriate address set forth in Section 10 of the Summary, or to such other place as Tenant may from time to time designate in a Notice to Landlord, or to Landlord at the addresses set forth below, or to such other places as Landlord may from time to time designate in a Notice to Tenant. Any Notice will be deemed given (i) three (3) days after the date it is posted if sent by Mail, (ii) the date the telecopy is transmitted, (iii) the date the overnight courier delivery is made, or (iv) the date personal delivery is made. As of the Effective Date, any Notices to Landlord must be sent, transmitted, or delivered, as the case may be, to the following addresses:
HCP Life Science REIT, Inc.<br><br>with a copy to:
HCP Life Science REIT, Inc.<br><br>c/o Healthpeak Properties, Inc.<br><br>1900 Main Street, 5th Floor<br><br>Irvine, CA 92614<br><br>Attn: Legal Department<br><br>Email*:
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--- ---
with a copy to:
---
Healthpeak Properties, Inc.<br><br>1900 Main Street, 5th Floor<br><br>Irvine, CA 92614<br><br>Attention: Scott Bohn
and
Allen Matkins Leck Gamble Mallory & Natsis LLP<br><br>2010 Main Street, 8th Floor <br>Irvine, California 92614<br>Attention: Brad H. Nielsen, Esq.

*The delivery of any Notices by either party to the other pursuant to this Section 29.18 shall include a commercially reasonable attempt by the delivering party to give a concurrent courtesy email notice to any email address set forth in this Lease for such purposes (or otherwise designated by Landlord or Tenant via written notice to the other party); provided, however, notwithstanding anything in the Lease to the contrary (including the foregoing), any failure of a delivering party to provide any such email notice shall not affect or invalidate any official Notices under the Lease (and the timing of receipt, or lack thereof, by the receiving party shall not affect any timing under this Lease based on such party's receipt of any Notices), except with respect to the email notices that Tenant is required to provide pursuant to the express terms of this Lease.

  • Joint and Several. If the "Tenant" under this Lease is comprised of more than one legal entity and/or persons, then the obligations imposed upon Tenant under this Lease shall be joint and several.
  • Authority. Landlord and Tenant each hereby represents and warrants that (i) such party duly formed and in good standing in such party's state of organization, (ii) such party is qualified to do business in California, (iii) such party has full right and authority to execute and deliver this Lease, and (iv) each person signing on behalf of such party is authorized to do so. Tenant shall, within ten (10) days after Landlord's request, deliver to Landlord satisfactory written evidence of the truth and accuracy of the foregoing representations and warranties.
  • Attorneys' Fees. In the event that either Landlord or Tenant should bring suit for the possession of the Premises, for the recovery of any sum due under this Lease, or because of the breach of any provision of this Lease or for any other relief against the other, then all costs and expenses, including reasonable attorneys' fees, incurred by the prevailing party therein shall be paid by the other party, which obligation on the part of the other party shall be deemed to have accrued on the date of the commencement of such action and shall be enforceable whether or not the action is prosecuted to judgment.
  • Governing Law; WAIVER OF TRIAL BY JURY; JUDICIAL REFERENCE.
  • Governing Law. This Lease shall be construed and enforced in accordance with the laws of the State of California. In any action or proceeding arising herefrom, Landlord and Tenant hereby consent to (i) the jurisdiction of any competent court within the State of California, and (ii) service of process by any means authorized by California law.
  • WAIVER OF TRIAL BY JURY. IN THE INTEREST OF SAVING TIME AND EXPENSE, TRIAL WITHOUT A JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM BROUGHT BY EITHER OF THE PARTIES HERETO AGAINST THE OTHER OR THEIR SUCCESSORS IN RESPECT OF ANY MATTER ARISING OUT OF OR IN CONNECTION WITH THIS LEASE, THE RELATIONSHIP OF LANDLORD AND TENANT, TENANT'S USE OR OCCUPANCY OF THE PREMISES, AND/OR ANY CLAIM FOR INJURY OR DAMAGE, OR ANY EMERGENCY OR STATUTORY REMEDY. IN THE EVENT LANDLORD COMMENCES ANY SUMMARY PROCEEDINGS OR ACTION FOR NONPAYMENT OF BASE RENT OR ADDITIONAL RENT, TENANT SHALL NOT INTERPOSE ANY COUNTERCLAIM OF ANY
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  • NATURE OR DESCRIPTION (UNLESS SUCH COUNTERCLAIM SHALL BE MANDATORY) IN ANY SUCH PROCEEDING OR ACTION, BUT SHALL BE RELEGATED TO AN INDEPENDENT ACTION AT LAW.
  • Judicial Reference. If the jury waiver provisions of this Section 29.22 are not enforceable under California law, then the following provisions shall apply. It is the desire and intention of the parties to agree upon a mechanism and procedure under which controversies and disputes arising out of this Lease or related to the Premises will be resolved in a prompt and expeditious manner. Accordingly, except with respect to actions for unlawful or forcible detainer or with respect to the prejudgment remedy of attachment, any action, proceeding or counterclaim brought by either party hereto against the other (and/or against its officers, directors, employees, agents or subsidiaries or affiliated entities) on any matters whatsoever arising out of or in any way connected with this Lease, Tenant's use or occupancy of the Premises and/or any claim of injury or damage, whether sounding in contract, tort, or otherwise, shall be heard and resolved by a referee under the provisions of the California Code of Civil Procedure, Sections 638 — 645.1, inclusive (as same may be amended, or any successor statute(s) thereto) (the "Referee Sections"). Any fee to initiate the judicial reference proceedings and all fees charged and costs incurred by the referee shall be paid by the party initiating such procedure (except that if a reporter is requested by either party, then a reporter shall be present at all proceedings where requested and the fees of such reporter – except for copies ordered by the other parties – shall be borne by the party requesting the reporter); provided however, that allocation of the costs and fees, including any initiation fee, of such proceeding shall be ultimately determined in accordance with Section 29.21 above. The venue of the proceedings shall be in the county in which the Premises are located. Within ten (10) days of receipt by any party of a written request to resolve any dispute or controversy pursuant to this Section 29.22, the parties shall agree upon a single referee who shall try all issues, whether of fact or law, and report a finding and judgment on such issues as required by the Referee Sections. If the parties are unable to agree upon a referee within such ten (10) day period, then any party may thereafter file a lawsuit in the county in which the Premises are located for the purpose of appointment of a referee under the Referee Sections. If the referee is appointed by the court, the referee shall be a neutral and impartial retired judge with substantial experience in the relevant matters to be determined, from JAMS, the American Arbitration Association or similar mediation/arbitration entity. the proposed referee may be challenged by any party for any of the grounds listed in the Referee Sections. The referee shall have the power to decide all issues of fact and law and report his or her decision on such issues, and to issue all recognized remedies available at law or in equity for any cause of action that is before the referee, including an award of attorneys' fees and costs in accordance with this Lease. The referee shall not, however, have the power to award punitive damages, nor any other damages which are prohibited by the express provisions of this Lease, and the parties hereby waive any right to recover any such damages. The parties shall be entitled to conduct all discovery as provided in the California Code of Civil Procedure, and the referee shall oversee discovery and may enforce all discovery orders in the same manner as any trial court judge, with rights to regulate discovery and to issue and enforce subpoenas, protective orders and other limitations on discovery available under California law. The reference proceeding shall be conducted in accordance with California law (including the rules of evidence), and in all regards, the referee shall follow California law applicable at the time of the reference proceeding. The parties shall promptly and diligently cooperate with one another and the referee, and shall perform such acts as may be necessary to obtain a prompt and expeditious resolution of the dispute or controversy in accordance with the terms of this Section 29.22. In this regard, the parties agree that the parties and the referee shall use best efforts to ensure that (a) discovery be conducted for a period no longer than six (6) months from the date the referee is appointed, excluding motions regarding discovery, and (b) a trial date be set within nine (9) months of the date the referee is appointed. In accordance with Section 644 of the California Code of Civil Procedure, the decision of the referee upon the whole issue must stand as the decision of the court, and upon the filing of the statement of decision with the clerk of the court, or with the judge if there is no clerk, judgment may be entered thereon in the same manner as if the action had been tried by the court. Any decision of the referee and/or judgment or other order entered thereon shall be appealable to the same extent and in the same manner that such decision, judgment, or order would be appealable if rendered by a judge of the Superior Court in which venue is proper hereunder. The referee shall in his/her statement of decision set forth his/her findings of fact and conclusions of law. the parties intend this general reference agreement to be specifically enforceable in accordance with the Code of Civil Procedure. Nothing in this Section 29.22 shall prejudice the right of any party to obtain provisional relief or other equitable remedies from a court of competent jurisdiction as shall otherwise be available under the code of civil procedure and/or applicable court rules.
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  • Submission of Lease. Submission of this instrument for examination or signature by Tenant does not constitute a reservation of, option for or option to lease, and it is not effective as a lease or otherwise until execution and delivery by both Landlord and Tenant.
  • Brokers. Landlord and Tenant hereby warrant to each other that they have had no dealings with any real estate broker or agent in connection with the negotiation of this Lease, excepting only the real estate brokers or agents specified in Section 12 of the Summary (the "Brokers"), and that they know of no other real estate broker or agent who is entitled to a commission in connection with this Lease. Each party shall indemnify and defend the other party against and hold the other party harmless from any and all Losses with respect to any leasing commission or equivalent compensation alleged to be owing on account of any dealings with any real estate broker or agent, other than the Brokers, occurring by, through, or under the indemnifying party. The terms of this Section 29.24 shall survive the expiration or earlier termination of the Lease Term. Landlord shall compensate Brokers as per a separate agreement.
  • Independent Covenants. This Lease shall be construed as though the covenants herein between Landlord and Tenant are independent and not dependent and Tenant hereby expressly waives the benefit of any statute to the contrary and agrees that if Landlord fails to perform its obligations set forth herein, Tenant shall not be entitled to make any repairs or perform any acts hereunder at Landlord's expense or to any setoff of the Rent or other amounts owing hereunder against Landlord, except as expressly set forth herein.
  • Project or Building Name, Address and Signage. Landlord shall have the right at any time to change the address or name of the Project or Building and to install, affix and maintain any and all signs on the exterior and on the interior of the Project or Building as Landlord may, in Landlord's sole discretion, desire. Tenant shall not use the name of the Project or Building, or the name or logo of Landlord (or any of its affiliates), or use pictures or depictions of the Project or Building, in advertising or other publicity (including, without limitation, any websites or social media accounts) or for any purpose, without the prior written consent of Landlord, not to be unreasonably withheld, conditioned, or delayed. Notwithstanding the foregoing, Tenant may use the name of the Building and Project as an element of Tenant's address with respect to the business to be conducted by Tenant in the Premises.
  • Counterparts. This Lease may be executed in counterparts with the same effect as if both parties hereto had executed the same document. Both counterparts shall be construed together and shall constitute a single lease.
  • Confidentiality. The content of this Lease and any related amendments, agreements and documents are confidential information. Landlord and Tenant shall keep such information strictly confidential and shall not disclose such confidential information, without the other party's prior written consent, to any person or entity other than (i) such party's respective financial, legal, space planning and construction consultants, such party's financing sources, and such party's parent, subsidiary or other affiliated companies, their partners, lenders, banks, auditors, underwriters, employees and attorneys and similar professionals, (ii) as may be required to enforce the provisions of this Lease, or (iii) as may be required to comply with Applicable Laws. In addition, notwithstanding the foregoing or anything to the contrary herein, (a) either party shall be entitled to (1) disclose information relating to this Lease and any related amendments to the extent necessary to comply with the disclosure or regulatory requirements of the S.E.C., IRS or similar entities, or in connection with other S.E.C., IRS or other regulatory filings customarily made by publicly traded entities (e.g., with respect to Landlord, those filings customarily made by publicly traded REIT entities); (2) disclose information relating to this Lease on earnings calls and/or at investor meetings as customarily disclosed by publicly traded entities or consistent with past practices; and (3) disclose information relating to this Lease to such party's prospective partners under commercially reasonable confidentiality terms; (b) Landlord shall be entitled to issue press releases with respect to the fact that this Lease has been entered into, the size and location of the Premises, the length of term, and the identity of Tenant (among other information commonly found in press releases announcing new lease transactions); and (c) Tenant shall be entitled to disclose the contents of this Lease and any related amendments to prospective assignees or sublessees under commercially reasonable confidentiality terms. The obligations in this Section 29.28 shall survive the expiration or earlier termination of this Lease.
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  • Development of the Project.
  • Subdivision. Landlord reserves the right to subdivide all or a portion of the Project, buildings and Common Areas. Tenant agrees to execute and deliver, within ten (10) business days of written demand by Landlord and in the commercially reasonable form requested by Landlord, any commercially reasonable additional documents needed to conform this Lease to the circumstances resulting from a subdivision and any all maps in connection therewith. Notwithstanding anything to the contrary set forth in this Lease, the separate ownership of portions of the Project, or any buildings and/or Common Areas, by an entity other than Landlord shall not affect the calculation of Direct Expenses or Tenant's payment of Tenant's Share of Direct Expenses.
  • Construction of Property and Other Improvements. Tenant acknowledges that (i) portions of the Project may be under construction following Tenant's occupancy of the Premises, including the construction of additional Project buildings, parking areas and structures, and other improvements, and (ii) that such construction may result in levels of noise, dust, obstruction of access, etc. which are substantially in excess of that present in a fully constructed project, including erecting scaffolding or other necessary structures in the Project, and limiting or eliminating access to portions of the Project, including portions of the Common Areas. Tenant hereby waives any and all rent offsets or claims of constructive eviction which may arise in connection with such construction, and further waives any Losses for any injuries or inconvenience to or interference with Tenant's business, lost profits, any loss of occupancy or quiet enjoyment of the Premises, and any other loss occasioned by such work. Notwithstanding the foregoing: (i) Landlord shall use commercially reasonable efforts to perform any such construction in a manner designed to minimize interference with Tenant's use of, and access to, the Premises; and (ii) such work shall not cause a reduction in the size of the Premises and/or change in the layout of the Premises (other than any de minimis extent as and to the extent required by any Applicable Laws, such as, for example, minor expansion of structural support columns due to required seismic upgrades).
  • No Violation. Tenant hereby warrants and represents that neither its execution of nor performance under this Lease shall cause Tenant to be in violation of any agreement, instrument, contract, law, rule or regulation by which Tenant is bound, and Tenant shall protect, defend, indemnify and hold Landlord harmless from and against any Losses arising from Tenant's breach of this warranty and representation.
  • Transportation Management. Tenant shall fully comply with all present or future programs intended to manage parking, transportation or traffic in and around the Project and/or the Building, and in connection therewith, Tenant shall take responsible action for the transportation planning and management of all employees located at the Premises by working directly with Landlord, any governmental transportation management organization or any other transportation-related committees or entities. Such programs may include, without limitation: (i) restrictions on the number of peak-hour vehicle trips generated by Tenant; (ii) increased vehicle occupancy; (iii) implementation of an in-house ridesharing program and an employee transportation coordinator; (iv) working with employees and any Project, Building or area-wide ridesharing program manager; (v) instituting employer-sponsored incentives (financial or in-kind) to encourage employees to rideshare; and (vi) utilizing flexible work shifts for employees.
  • Prohibited Persons; Foreign Corrupt Practices Act and Anti-Money Laundering. Tenant hereby represents and warrants to Landlord, that neither Tenant nor any of its affiliates, nor any of their respective members, partners or other equity holders, and none of their respective officers, directors or managers is, nor prior to or during the Lease Term, will become a person or entity with whom U.S. persons or entities are restricted from doing business under (a) the Patriot Act (as defined below), (b) any other requirements contained in the rules and regulations of the Office of Foreign Assets Control, Department of the Treasury ("OFAC") (including any "blocked" person or entity listed in the Annex to Executive Order Nos. 12947, 13099 and 13224 and any modifications thereto or thereof or any other person or entity named on OFAC's Specially Designated Blocked Persons List) or (c) any other U.S. statute, Executive Order (including the September 24, 2001, Executive Order Blocking Property and Prohibiting Transactions with Persons Who Commit, Threaten to Commit or Support Terrorism) or other governmental action (collectively, "Prohibited Persons"). Tenant further represents and warrants to Landlord that Tenant and its employees and all persons acting on its behalf have at all times fully complied with, and are currently in full compliance with, the Foreign Corrupt Practices Act of 1977 and any other applicable anti-bribery or anti-corruption laws. Tenant is not entering into this Lease, directly or indirectly, in violation of any laws relating to drug trafficking, money laundering or predicate crimes to money laundering. As used herein, "Patriot Act" shall mean the USA Patriot
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  • Act of 2001, 107 Public Law 56 (October 26, 2001) and all other statutes, orders, rules and regulations of the U.S. government and its various executive departments, agencies and offices interpreting and implementing the Patriot Act.
  • Signatures. The parties hereto consent and agree that this Lease may be signed and/or transmitted by facsimile, e-mail of a .pdf document or using electronic signature technology (e.g., via DocuSign or similar electronic signature technology), and that such signed electronic record shall be valid and as effective to bind the party so signing as a paper copy bearing such party's handwritten signature. The parties further consent and agree that (1) to the extent a party signs this Lease using electronic signature technology, by clicking "SIGN", such party is signing this Lease electronically, and (2) the electronic signatures appearing on this Lease shall be treated, for purposes of validity, enforceability and admissibility, the same as handwritten signatures.
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IN WITNESS WHEREOF, Landlord and Tenant have caused this Lease to be executed as of the Effective Date.

LANDLORD: TENANT:
HCP LIFE SCIENCE REIT, INC., <br>a Maryland corporation KURA ONCOLOGY, INC.,<br>a Delaware corporation
By: /s/ Scott Bohn By: /s/ Tom Doyle
Scott Bohn Tom Doyle
Print Name
Its: Chief Development Officer
Its: Senior Vice President, Finance and Accounting
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--- ---

EXHIBIT A

DIRECTORS SCIENCE PARK

OUTLINE OF PREMISES

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EXHIBIT A<br><br>-1- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788

EXHIBIT A-1

DIRECTORS SCIENCE PARK

PROJECT SITE PLAN

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EXHIBIT A-1<br><br>-1- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788

EXHIBIT B

DIRECTORS SCIENCE PARK

TENANT WORK LETTER

This Tenant Work Letter shall set forth the terms and conditions relating to the initial improvement of the Premises for Tenant following the date of this Lease. This Tenant Work Letter is essentially organized chronologically and addresses the issues of construction, in sequence, as such issues will arise during construction in the Premises. Capitalized terms not defined herein shall have the meaning ascribed to them in the Lease.

SECTION 1

POSSESSION OF THE PREMISES

Tenant acknowledges that Tenant has thoroughly examined the Premises. On the Possession Date, Landlord shall tender possession of the Premises to Tenant in its presently existing, "as-is" condition. Except for the payment of the Tenant Improvement Allowance as provided in Section 2, below, Landlord shall have no obligation to make or pay for any improvements to the Premises. For the avoidance of doubt, Tenant's installation of FF&E shall not be deemed to be commencing to conduct business in the Premises for purposes of the Lease Commencement Date.

SECTION 2

TENANT IMPROVEMENTS

  • Tenant Improvement Allowance. Commencing as of the Possession Date, Tenant shall be entitled to use the "Tenant Improvement Allowance", as defined in Section 5 of the Summary to this Lease, for the costs relating to the initial design, engineering, permitting, and construction of Tenant's improvements, which are permanently affixed to the Premises or which are "Tenant Improvement Allowance Items," as that term is defined in Section 2.2.1, below (collectively, the "Tenant Improvements"). Tenant shall also be entitled to use up to Twenty-Two and 50/100 Dollars ($22.50) per rentable square foot of the Premises of the Tenant Improvement Allowance toward the cost of Tenant Signage, cabling, furniture, fixtures, laboratory equipment, office equipment (the foregoing "FF&E") and moving expenses, and other related facilities costs reasonably approved by Landlord (collectively, the "Additional Allowable Costs"); provided, however in no event shall the aggregate amount of such Tenant Allowance used for Additional Allowable Costs exceed Seven Hundred Thirty-One Thousand Five Hundred Twenty and No/100 Dollars ($731,520.00). In no event shall Landlord be obligated to make disbursements pursuant to this Tenant Work Letter or otherwise in connection with Tenant's construction of the Tenant Improvements or any Tenant Improvement Allowance Items, as defined below, or in connection with the Additional Allowable Costs, in a total amount which exceeds the sum of the Tenant Improvement Allowance (except for the Elected Additional TI Allowance pursuant to the terms of Section 2.1.1 below). All Tenant Improvements and Additional Allowable Costs items for which the Tenant Improvement Allowance has been made available shall be deemed Landlord's property under the terms of the Lease; provided, however, (i) Tenant shall not be required to remove any Tenant Improvements prior to the end of the Lease Term, and (ii) Landlord may, by written notice to Tenant given within ninety (90) days prior to the end of the Lease Term, require Tenant, prior to the end of the Lease Term, at Tenant's expense, to remove any Additional Allowable Costs items and to repair any damage to the Premises and Building caused by such removal. Any portion of the Tenant Improvement Allowance that is not disbursed or allocated for disbursement by the date which is eighteen (18) months following the Effective Date, shall revert to Landlord and Tenant shall have no further rights with respect thereto. Notwithstanding anything to the contrary contained herein, Landlord shall be responsible for the costs of an initial Tenant test-fit up to $0.15 per rentable square foot of the Premises (i.e. $4,876.80).
  • Additional Tenant Improvement Allowance. In addition to the Tenant Improvement Allowance, Tenant shall have the right, by written notice to Landlord and PMA (defined below) given concurrently with Tenant's provision of the "Final Budget", as defined in Section 4.2.1, below, to use up to Twenty-Five and No/100 Dollars ($25.00) per rentable square foot (i.e., a total of $812,800.00 based upon 32,512 rentable square feet in the Premises) (the "Additional TI Allowance") towards the payment of the Tenant Improvement Allowance Items;
EXHIBIT B<br><br>-1- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
  • provided, however, Tenant shall be entitled to use up to Ten and No/100 Dollars ($10.00) per rentable square foot of the Premises of the Additional TI Allowance toward the Additional Allowable Costs as pre-approved in writing by Landlord. Concurrently with Tenant's delivery of the Final Budget, Tenant shall notify Landlord in writing (the "ATIA Election Notice"), which notice shall be in the form attached as Schedule 2 to this Tenant Work Letter, of the amounts, if any, of the Additional TI Allowance that Tenant desires to utilize (the "Elected Additional TI Allowance"). In the event Tenant exercises its right to use all or any portion of the Additional TI Allowance, Tenant shall be required to pay Landlord, commencing on the Lease Commencement Date (the "Additional Payment Commencement Date"), the "Additional TI Allowance Payment," as that term is defined below, in consideration of Landlord provision of the Additional TI Allowance. The "Additional TI Allowance Payment" shall be determined as the missing component of an annuity, which annuity shall have (i) the amount of the Elected Additional TI Allowance as the present value amount, (ii) a number equal to the number of full calendar months then remaining in the Lease Term as the number of payments, (iii) a monthly interest factor equal to three quarters of a percent (0.75%), which is equal to nine percent (9%) divided by twelve (12) months per year, and (iv) the Additional TI Allowance Payment as the missing component of the annuity, and shall not be subject to annual escalations. Following the calculation of the Additional TI Allowance Payment and no later than 30 days after Tenant's delivery of the ATIA Election Notice, Landlord and Tenant will enter into a lease amendment in the form of Schedule 1 attached to this Tenant Work Letter, to confirm the amount thereof (the "Additional TI Amendment"). If Tenant fails to timely provide the ATIA Election Notice to Landlord, Tenant shall have no further right to any Additional TI Allowance.
  • Disbursement of the Tenant Improvement Allowance.
  • Tenant Improvement Allowance Items. Except as otherwise set forth in this Tenant Work Letter, the Tenant Improvement Allowance and Additional TI Allowance, if applicable, shall be disbursed by Landlord only for the following items and costs (collectively the "Tenant Improvement Allowance Items"):
  • Payment of all reasonable fees of the "Architect" and the "Engineers," as those terms are defined in Section 3.1 of this Tenant Work Letter, project management fees, and payment of the fees incurred by, and the cost of documents and materials supplied by, Landlord and Landlord's consultants in connection with the preparation and review of the "Construction Drawings," as that term is defined in Section 3.2 of this Tenant Work Letter;
  • The payment of plan check, permit and license fees relating to construction of the Tenant Improvements;
  • The payment for all demolition and removal of existing improvements in the Premises;
  • The cost of construction of the Tenant Improvements, including, without limitation, testing and inspection costs, costs incurred for removal of existing furniture, fixtures or equipment in the Premises, hoisting and trash removal costs, costs to purchase and install in the Premises equipment customarily incorporated into laboratory improvements or laboratory utility systems, including, without limitation, UPS, DI Systems, boilers, air compressors, glass/cage washers and autoclaves, painting, and contractors' fees and general conditions (but not including any FF&E, the costs of which FF&E shall not be paid for by the Tenant Improvement Allowance, other than as expressly permitted for Additional Allowable Costs);
  • The cost of any changes in the Base Building when such changes are required by the Construction Drawings (including if such changes are due to the fact that such work is prepared on an unoccupied basis), such cost to include all direct architectural and/or engineering fees and expenses incurred in connection therewith;
  • The cost of any changes to the Construction Drawings or Tenant Improvements required by all applicable building codes (the "Code");
  • Sales and use taxes;
EXHIBIT B<br><br>-2- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
  • Subject to Section 2.2, above, all other actual and reasonable out-of-pocket costs expended by Landlord in connection with the construction of the Tenant Improvements, including, without limitation, costs expended by Landlord pursuant to Section 4.1.1 of this Tenant Work Letter (which costs Tenant agrees shall be deemed to be reasonable), below.
  • Disbursement of Tenant Improvement Allowance. During the construction of the Tenant Improvements, Landlord shall make monthly disbursements of the Tenant Improvement Allowance and Additional TI Allowance, if applicable, for Tenant Improvement Allowance Items for the benefit of Tenant and shall authorize the release of monies for the benefit of Tenant as follows.
  • Monthly Disbursements. On or before the fifth (5th) day of each calendar month, during the design and construction of the Tenant Improvements (or such other date as Landlord may designate), Tenant shall deliver to Landlord: (i) a request for reimbursement of amounts paid to the "Contractor," as that term is defined in Section 4.1.1 of this Tenant Work Letter, approved by Tenant, in a form to be provided by Landlord, showing the schedule, by trade, of percentage of completion of the Tenant Improvements in the Premises, detailing the portion of the work completed and the portion not completed; (ii) invoices from all of "Tenant's Agents," as that term is defined in Section 4.1.2 of this Tenant Work Letter, for labor rendered and materials for the Premises; (iii) executed mechanic's lien releases, as applicable, from all of Tenant's Agents which shall comply with the appropriate provisions, as reasonably determined by Landlord, of California Civil Code Sections 8132, 8134, 8136 and 8138; and (iv) all other commercially reasonable information reasonably requested by Landlord. Tenant's request for payment shall be deemed Tenant's acceptance and approval of the work furnished and/or the materials supplied as set forth in Tenant's payment request. Within forty-five (45) days thereafter, and provided that Tenant has paid the "Tenant Contribution" as provided in Section 4.2.1, below, Landlord shall deliver a check to Tenant made payable to Tenant, or, if so directed by Tenant, to the Contractor, in payment of the lesser of: (A) the amounts so requested by Tenant as set forth in this Section 2.2.3.1, above (less the Tenant Contribution, if applicable), less a ten percent (10%) retention (the aggregate amount of such retentions to be known as the "Final Retention"), and (B) the balance of any remaining available portion of the Tenant Improvement Allowance and Additional TI Allowance, if applicable (not including the Final Retention, provided that Landlord does not dispute any request for payment based on non-compliance of any work with the "Approved Working Drawings," as that term is defined in Section 3.5 below, or due to any substandard work. Landlord's payment of such amounts shall not be deemed Landlord's approval or acceptance of the work furnished or materials supplied as set forth in Tenant's payment request.
  • Final Deliveries. Following the completion of construction of the Tenant Improvements, Tenant shall deliver to Landlord (i) properly executed final mechanic's lien releases in compliance with both California Civil Code Section 8134 and either Section 8136 or Section 8138 from all of Tenant's Agents, and a certificate certifying that the construction of the Tenant Improvements in the Premises has been substantially completed, and (ii) a "close-out package" in such format designated by Landlord (e.g., paper and/or electronic files) containing, without limitation, the following items (to the extent deemed necessary by Landlord): (a) as-built drawings and final record CAD drawings, (b) warranties and guarantees from all contractors, subcontractors and material suppliers, (c) all permits, approvals and other documents issued by any governmental agency in connection with the Tenant Improvements, (d) an independent air balance report, if required due to the nature of the Tenant Improvements, and (e) such other commercially reasonable information or materials as may be reasonably requested by Landlord. Tenant shall record a valid Notice of Completion in accordance with the requirements of Section 4.3 of this Tenant Work Letter.
  • Other Terms. Landlord shall only be obligated to make disbursements from the Tenant Improvement Allowance and Additional TI Allowance, if applicable, to the extent costs are incurred by Tenant for Tenant Improvement Allowance Items. All Tenant Improvement Allowance Items for which the Tenant Improvement Allowance and Additional TI Allowance, if applicable, have been made available shall be deemed Landlord's property under the terms of this Lease.
  • Building Standards. The quality of Tenant Improvements shall be in keeping with the existing improvements in the Premises.
EXHIBIT B<br><br>-3- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788

SECTION 3

CONSTRUCTION DRAWINGS

  • Selection of Architect. Tenant retained McFarlane Architects (the "Architect") to prepare the Approved Space Plan and Final Working Drawings as provided in Sections 3.2 and 3.3, below. Tenant shall retain the engineering consultants or design/build subcontractors designated by Tenant and reasonably approved in advance by Landlord (the "Engineers") to prepare all plans and engineering working drawings relating to the structural, mechanical, electrical, plumbing, HVAC, lifesafety, and sprinkler work in the Premises, which work is not part of the Base Building. All such plans and drawings shall comply with the drawing format and specifications reasonably determined by Landlord, and shall be subject to Landlord's reasonable approval, not to be unreasonably conditioned or delayed. Tenant and Architect shall verify, in the field, the dimensions and conditions as shown on the relevant portions of the Base Building plans, and Tenant and Architect shall be solely responsible for the same, and Landlord shall have no responsibility in connection therewith. Landlord's review of any plans or drawings as set forth in this Section 3, shall be for its sole purpose and shall not imply Landlord's review of the same, or obligate Landlord to review the same, for quality, design, Code compliance or other like matters.
  • Approved Space Plan. The term "Approved Space Plan" shall mean that certain space plan (and associated scope of work list) approved by Landlord and Tenant, which Approved Space Plan is attached hereto as Schedule 3. Tenant shall make no changes, additions or modifications to the Tenant Improvements or the Approved Space Plan without the prior written consent of Landlord, which consent shall not be unreasonably withheld, conditioned, or delayed.
  • Final Working Drawings. Following the Effective Date of this Lease, Tenant shall promptly supply the Engineers with a complete listing of standard and non-standard equipment and specifications, including, without limitation, Title 24 calculations, electrical requirements and special electrical receptacle requirements for the Premises, to enable the Engineers and the Architect to complete the "Final Working Drawings" (as that term is defined below) in the manner as set forth below. Tenant shall promptly cause the Architect and the Engineers to complete the architectural and engineering drawings for the Premises, and Architect shall compile a fully coordinated set of architectural, structural, mechanical, electrical and plumbing working drawings in a form which is sufficiently complete to allow all of Tenant's Agents to bid on the work and to obtain all applicable permits (collectively, the "Final Working Drawings") and shall submit the same to Landlord for Landlord's approval, which shall not be unreasonably withheld, conditioned, or delayed. Tenant shall supply Landlord with CAD and pdf copies of such Final Working Drawings, digitally signed by Tenant. Landlord shall advise Tenant within ten (10) business days after Landlord's receipt of the Final Working Drawings for the Premises if the same is unsatisfactory or incomplete in any respect (as reasonably determined by Landlord). If Tenant is so advised, Tenant shall promptly cause the Final Working Drawings to be revised in accordance with such review and any disapproval of Landlord in connection therewith. In addition, if Landlord in its sole yet reasonable discretion determines that the Final Working Drawings or any amendment thereof or supplement thereto shall require review by a third party (e.g., architect or engineer), then Landlord shall so notify Tenant of the need and cost for such review, and Tenant shall pay the actual and reasonable costs and fees of such third party review in advance upon receipt of notice thereof. Further, notwithstanding anything contained herein to the contrary, in all events, the Final Working Drawings and the Approved Working Drawings shall conform with, and shall not exceed, the Building Systems capacities available to the Premises as described on Exhibit F attached hereto.
  • Approved Working Drawings. The Final Working Drawings shall be approved by Landlord (the "Approved Working Drawings") prior to the commencement of construction of the Premises by Tenant. Concurrently with Tenant's delivery of the Final Working Drawings to Landlord for Landlord's approval, Tenant may submit the same to the appropriate municipal authorities for all applicable building permits. Tenant hereby agrees that neither Landlord nor Landlord's consultants shall be responsible for obtaining any building permit or certificate of occupancy for the Premises and that obtaining the same shall be Tenant's responsibility; provided, however, that Landlord shall cooperate with Tenant in executing permit applications and performing other ministerial acts reasonably necessary to enable Tenant to obtain any such permit or certificate of occupancy. No changes, modifications or alterations in the Approved Working Drawings may be made without the prior written consent of Landlord, which shall not be unreasonably withheld, conditioned, or delayed.
EXHIBIT B<br><br>-4- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
  • Change Orders. If Tenant at any time desires any changes, alterations or additions to the Approved Working Drawings, Tenant shall submit a detailed written request to Landlord and PMA (as defined in Section 4.1.1 below) specifying such changes, alterations or additions (a "Tenant Change Request"), for Landlord's approval, not to be unreasonably withheld, conditioned, or delayed. Landlord shall advise Tenant within five (5) business days after Landlord's receipt of a Tenant Change Request if the same is unsatisfactory or incomplete in any respect. If Tenant is so advised, Tenant shall promptly cause the Tenant Change Request to be revised to correct any deficiencies or other matters Landlord may reasonably require.

SECTION 4

CONSTRUCTION OF THE TENANT IMPROVEMENTS

  • Tenant's Selection of Contractors.
  • The Contractor; Landlord's Project Manager. Tenant shall retain JB Pacific to construct the Tenant Improvements (the "Contractor"). Landlord shall retain Project Management Advisors, Inc. ("PMA") as a third party project manager for construction oversight of the Tenant Improvements on behalf of Landlord, and Tenant shall pay a fee to Landlord with respect to the PMA services equal to one percent (1%) of the total construction hard costs which amount shall be immediately deducted from the Tenant Improvement Allowance; provided, however, Tenant shall also be permitted to retain its own project manager to oversee the design, construction and completion of the Tenant Improvements (provided such project manager shall cooperate and coordinate with PMA to allow PMA reasonable oversight of the construction and completion of the Tenant Improvements), and, in the event Tenant elects to engage its own project manager, Tenant shall pay to Landlord a project management fee up to four percent (4%) of hard costs associated with the construction of the Tenant Improvements.
  • Tenant's Agents. All subcontractors, laborers, materialmen, and suppliers used by Tenant (such subcontractors, laborers, materialmen, and suppliers, and the Contractor to be known collectively as "Tenant's Agents"). The subcontractors used by Tenant, but not any laborers, materialmen, and suppliers, must be approved in writing by Landlord, which approval shall not be unreasonably withheld, conditioned, or delayed; provided, however, Landlord may nevertheless designate and require the use of particular mechanical, engineering, plumbing, fire life-safety and other Base Building subcontractors. If Landlord does not approve any of Tenant's proposed subcontractors, Tenant shall submit other proposed subcontractors for Landlord's written approval.
  • Construction of Tenant Improvements by Tenant's Agents.
  • Construction Contract; Cost Budget.

Tenant shall engage the Contractor under a commercially reasonable and customary construction contract, reasonably approved by Landlord (collectively, the "Contract"). Prior to the commencement of the construction of the Tenant Improvements, and after Tenant has accepted all bids for the Tenant Improvements, Tenant shall provide Landlord with a detailed breakdown, by trade, of the final costs to be incurred or which have been incurred, as set forth more particularly in Sections 2.2.1.1 through 2.2.1.10, above, in connection with the design and construction of the Tenant Improvements to be performed by or at the direction of Tenant or the Contractor, which costs form a basis for the estimated total costs of the work of the Tenant Improvement project (the "Final Budget"). Prior to the commencement of construction of the Tenant Improvements, Tenant shall supply Landlord with cash in an amount (the "Over-Allowance Amount") equal to the difference between the amount of the Final Costs and the amount of the Tenant Improvement Allowance (and, if applicable, the Elected Additional TI Allowance) (less any portion thereof already disbursed by Landlord, or in the process of being disbursed by Landlord, on or before the commencement of construction of the Tenant Improvements). The Over-Allowance Amount, at Landlord's sole option, shall be disbursed by Landlord prior to the disbursement of any of the then remaining portion of the Tenant Improvement Allowance (and, if applicable, the Elected Additional TI Allowance), and such disbursement shall be pursuant to the same procedure as the Tenant Improvement Allowance (and, if applicable, the Elected Additional TI Allowance). In the event that, after the Final Costs have been delivered by Tenant to Landlord, the costs relating to the design and construction of the Tenant Improvements shall change, any additional costs necessary to such design and construction in excess of the Final Costs, shall be paid by Tenant to Landlord immediately as an addition to the Over-Allowance Amount or at Landlord's option, Tenant shall make payments for such additional costs out of its own

EXHIBIT B<br><br>-5- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788

funds, but Tenant shall continue to provide Landlord with the documents described in Sections 2.2.2.1 (i), (ii), (iii) and (iv) of this Tenant Work Letter, above, for Landlord's approval, prior to Tenant paying such costs. All Tenant Improvements paid for by the Over-Allowance Amount shall be deemed Landlord's property under the terms of the Lease.

  • Tenant's Agents.
  • Compliance with Drawings and Schedule. Tenant's and Tenant's Agent's construction of the Tenant Improvements shall comply with the following: (i) the Tenant Improvements shall be constructed in strict accordance with the Approved Working Drawings; and (ii) Tenant's Agents shall submit schedules of all work relating to the Tenant's Improvements to the Contractor and the Contractor shall, within five (5) business days of receipt thereof, inform Tenant's Agents of any changes which are necessary thereto, and Tenant's Agents shall adhere to such corrected schedule.
  • Indemnity. Tenant's indemnity of Landlord as set forth in this Lease shall also apply with respect to any and all costs, losses, damages, injuries and liabilities related in any way to any act or omission of Tenant or Tenant's Agents, or anyone directly or indirectly employed by any of them, or in connection with Tenant's non-payment of any amount arising out of the Tenant Improvements and/or Tenant's disapproval of all or any portion of any request for payment.
  • Requirements of Tenant's Agents. Each of Tenant's Agents shall guarantee to Tenant and for the benefit of Landlord that the portion of the Tenant Improvements for which it is responsible shall be free from any defects in workmanship and materials for a period of not less than one (1) year from the date of substantial completion of the work under the Contract ("Substantial Completion"). Each of Tenant's Agents shall be responsible for the replacement or repair, without additional charge, of all work done or furnished in accordance with its contract that shall become defective within one (1) year after Substantial Completion. The correction of such work shall include, without additional charge, all additional expenses and damages incurred in connection with such removal or replacement of all or any part of the Tenant Improvements, and/or the Building and/or common areas that may be damaged or disturbed thereby. All such warranties or guarantees as to materials or workmanship of or with respect to the Tenant Improvements shall be contained in the Contract or subcontract and shall be written such that such guarantees or warranties shall inure to the benefit of both Landlord and Tenant, as their respective interests may appear, and can be directly enforced by either. Tenant covenants to give to Landlord any assignment or other assurances which may be necessary to effect such right of direct enforcement.
  • Insurance Requirements.
  • General Coverages. All of Tenant's Agents shall carry the following insurance with insurers having a minimum A.M. best rating of A- VIII or better (i) worker's compensation insurance covering all of Tenant's Agents' respective employees with a waiver of subrogation in favor of Landlord and the property manager, (ii) general liability insurance with a limit of not less than $1,000,000 per occurrence and $2,000,000 general aggregate, including products/completed operations and contractual coverage, and shall name Landlord, its subsidiaries and affiliates, its property manager (if any) and any other party the Landlord so specifies, as an additional insured or loss payee, as applicable, including Landlord's managing agent, if any, and (iii) if the cost of such Tenant Improvements exceeds $100,000 in the aggregate, then Builders Risk insurance covering the construction of the Tenant Improvements, and such policy shall include Landlord as an additional insured.
  • General Terms. Certificates for all insurance carried pursuant to this Section 4.2.2.3 shall be delivered to Landlord before the commencement of construction of the Tenant Improvements and before the Contractor's equipment is moved onto the site. All such policies of insurance must contain a provision that the company writing said policy will endeavor to give Landlord thirty (30) days prior written notice of any cancellation or lapse of the effective date or any reduction in the amounts of such insurance. In the event that the Tenant Improvements are damaged by any cause during the course of the construction thereof, except to the extent of the gross negligence or willful misconduct of Landlord, its agents, employees, or contractors, but subject to the waiver of subrogation requirements of this Lease, Tenant shall promptly repair the same at Tenant's sole cost and expense. Tenant's Agents shall maintain all of the foregoing insurance coverage in force until the Tenant Improvements are fully completed, except for any Products and Completed Operation Coverage insurance required
EXHIBIT B<br><br>-6- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
  • by Landlord, which is to be maintained for ten (10) years following completion of the work. Such insurance shall provide that it is primary insurance as respects the owner and that any other insurance maintained by owner is excess and noncontributing with the insurance required hereunder. The requirements for the foregoing insurance shall not derogate from the provisions for indemnification of Landlord by Tenant under Section 4.2.2.2 of this Tenant Work Letter.
  • Governmental Compliance. The Tenant Improvements shall comply in all respects with the following: (i) all state, federal, city or quasi-governmental laws, codes, ordinances and regulations, as each may apply according to the rulings of the controlling public official, agent or other person; (ii) applicable standards of the American Insurance Association (formerly, the National Board of Fire Underwriters) and the National Electrical Code; and (iii) building material manufacturer's specifications.
  • Inspection by Landlord. Landlord shall have the right to inspect the Tenant Improvements at all times during the construction of the Tenant Improvements, provided however, that Landlord's failure to inspect the Tenant Improvements shall in no event constitute a waiver of any of Landlord's rights hereunder nor shall Landlord's inspection of the Tenant Improvements constitute Landlord's approval of the same. Should Landlord reasonably disapprove any portion of the Tenant Improvements, on the grounds that the construction is defective or fails to comply with the Approved Working Drawings, Landlord shall notify Tenant in writing of such disapproval and shall specify the items disapproved. Any such defects or deviations shall be rectified by Tenant at no expense to Landlord, provided however, that in the event Landlord determines that a defect or deviation exists that might adversely affect the mechanical, electrical, plumbing, heating, ventilating and air conditioning or life-safety systems of the Building, the structure or exterior appearance of the Building or any other tenant's use of such other tenant's leased premises, Landlord may, take such action as Landlord reasonably deems necessary, at Tenant's expense and without incurring any liability on Landlord's part, to correct any such defect, deviation and/or matter, including, without limitation, causing the cessation of performance of the construction of the Tenant Improvements until such time as the defect, deviation and/or matter is corrected to Landlord's reasonable satisfaction.
  • Meetings. Commencing upon the execution of this Lease, Tenant shall hold weekly meetings at a reasonable time, with the Architect and the Contractor regarding the progress of the preparation of Construction Drawings and the construction of the Tenant Improvements, and Landlord and/or its agents shall receive prior notice (which notice can be provided by email to Landlord's Representative) of, and shall have the right to attend, all such meetings, and, upon Landlord's request, certain of Tenant's Agents shall attend such meetings. In addition, minutes shall be taken at all such meetings, a copy of which minutes shall be promptly delivered to Landlord. One such meeting each month shall include the review of the Contractor's current request for payment.
  • Notice of Completion; Copy of Record Set of Plans. Within ten (10) business days after completion of construction of the Tenant Improvements, Tenant shall cause a valid Notice of Completion to be recorded in the office of the Recorder of the county in which the Building is located in accordance with Section 8182 of the Civil Code of the State of California or any successor statute, and shall furnish a copy thereof to Landlord upon such recordation. If Tenant fails to do so, Landlord may execute and file the same on Tenant's behalf, at Tenant's sole cost and expense. At the conclusion of construction, (i) Tenant shall cause the Architect and Contractor (w) to update the Approved Working Drawings as necessary to reflect all changes made to the Approved Working Drawings during the course of construction, (x) to certify to the best of their knowledge that the "record-set" of as-built drawings are true and correct, which certification shall survive the expiration or termination of this Lease, (y) to deliver to Landlord two (2) sets of copies of such record set of drawings (consisting of the applicable CAD files) within ninety (90) days following issuance of a certificate of occupancy for the Premises, and (z) deliver to Landlord a permit card with all required final signoffs from the applicable governmental agencies, and (ii) Tenant shall deliver to Landlord a copy of all warranties, guaranties, and operating manuals and information relating to the improvements, equipment, and systems in the Premises. Within fifteen (15) days after request by Tenant following the Substantial Completion of the Tenant Improvements, Landlord will acknowledge its approval of the Tenant Improvements (provided that such approval has been granted) by placing its signature on a Contractor's Certificate of Substantial Completion fully executed by the Architect, Contractor and Tenant. Landlord's approval shall not create any contingent liabilities for Landlord with respect to any latent quality, design, Code compliance or other like matters that may arise subsequent to Landlord's approval.
EXHIBIT B<br><br>-7- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788

SECTION 5

MISCELLANEOUS

  • Intentionally Omitted.
  • Tenant's Representative. Tenant has designated Mike Trout and Stephanie MacLeod as its sole representatives with respect to the matters set forth in this Tenant Work Letter, who shall each have full authority and responsibility to act on behalf of the Tenant as required in this Tenant Work Letter.
  • Landlord's Representative. Landlord has designated Melissa Plaskonos and Connor Alen-Lee with PMA, as its sole representative with respect to the matters set forth in this Tenant Work Letter, who, until further notice to Tenant, shall have full authority and responsibility to act on behalf of the Landlord as required in this Tenant Work Letter.
  • Time is of the Essence in This Tenant Work Letter. Unless otherwise indicated, all references herein to a "number of days" shall mean and refer to calendar days. If any item requiring approval is timely disapproved by Landlord, the procedure for preparation of the document and approval thereof shall be repeated until the document is approved by Landlord.
  • Tenant's Lease Default. Notwithstanding any provision to the contrary contained in the Lease or this Tenant Work Letter, upon any Event of Default by Tenant under the Lease or this Tenant Work Letter (including, without limitation, any failure by Tenant to fund any portion of the Over-Allowance Amount) occurs at any time on or before the Substantial Completion of the Tenant Improvements and such default remains uncured ten (10) business days following Landlord's notice of such default to Tenant, then in addition to all other rights and remedies granted to Landlord pursuant to the Lease, Landlord shall have the right to withhold payment of all or any portion of the Tenant Improvement Allowance and/or Landlord may, without any liability whatsoever, cause the cessation of construction of the Tenant Improvements and cessation of any work required to be performed by Landlord pursuant to this Tenant Work Letter (in which case, Tenant shall be responsible for any delay and any costs occasioned thereby).
  • Holdover Damages; Landlord Caused Delay. Tenant hereby represents and warrants to Landlord that (i) Tenant is currently leasing approximately 5,315 rentable square feet of space on the first floor located in that certain building addressed as 5510 Morehouse Drive, San Diego, California (the "Tenant's Existing Space"), and (ii) the lease term of Tenant's lease of Tenant's Existing Space is currently scheduled to expire on August 31, 2025 (the "Scheduled Surrender Date"). If, and only if, to the extent directly caused by a Landlord Caused Delay (as defined below) Tenant is unable to Substantially Complete the Tenant Improvements on or prior to September 30, 2025 (the "Outside Holdover Penalty Date"), then for the period (the "Holdover Damage Period") from the Outside Holdover Penalty Date until the day before the date Tenant Substantially Completes the Tenant Improvements, Landlord shall reimburse Tenant for the Holdover Damages (as defined below) actually paid by Tenant for and attributable to the Holdover Damage Period; provided, however, in no event shall the Holdover Damage Period occur before the Scheduled Surrender Date or extend beyond the date the Commencement Date has otherwise occurred pursuant to clause (i) in the definition of the Lease Commencement Date in and shown on Section 3.2 of the Summary, if applicable; provided further that in no event shall the Holdover Damage Period be longer than two (2) months. Any such reimbursement by Landlord of the Holdover Damages shall be paid by Landlord to Tenant on or before the date (the "Holdover Payment Date") which is thirty (30) days after the date Tenant delivers to Landlord written evidence of the amount of the Holdover Damages actually paid by Tenant during and attributable to the Holdover Damage Period so long as Tenant is not in default under this Lease beyond applicable notice and cure periods. As used herein, the "Holdover Damages" shall mean the total amount by which (i) Tenant's base rental obligations (including any increase therein resulting from Tenant's holding over in Tenant's Existing Space during each month, or partial month, during the Holdover Damage Period, but excluding any operating expenses, tax expenses, utilities costs and any other amounts) actually paid by Tenant under Tenant's lease of Tenant's Existing Space during each month, or partial month, during the Holdover Damage Period, exceeds (ii) the base rental obligations payable by Tenant for Tenant's Existing Space during the month of August, 2025. Tenant represents and warrants to Landlord that the current monthly amount of Holdover Damages, which would be incurred by Tenant per month under its existing lease of Tenant's Existing Space, is $12,922.45 per month (which is calculated based on a holdover base rental rate of 150% of the total base rental monthly installment amount of $25,844.90 that is due and payable for the month of August, 2025, which 150%
EXHIBIT B<br><br>-8- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
  • amount of base rent equals a monthly amount of $38,767.35). Tenant covenants that without Landlord's prior consent (which may be withheld in Landlord's sole and absolute discretion), Tenant shall not amend its existing lease of Tenant's Existing Space in any manner which will provide for greater base rent (including holdover rent) than is currently payable thereunder, and if Tenant does so without Landlord's prior consent, the increased payment amounts shall be excluded from the calculation of Holdover Damages provided in this Section 5.6. Notwithstanding anything in the foregoing to the contrary, in no event shall Landlord be responsible for (nor shall the Holdover Damages include) any loss of business, special, punitive, or other consequential damages that Tenant may incur with respect to Tenant's holdover of Tenant's Existing Space.

As used in this Lease, "Landlord Caused Delay" shall mean only an actual delay to the Substantial Completion of the Tenant Improvements resulting from: (i) failure of Landlord to approve or disapprove any construction drawings, within the time frames required under this Tenant Work Letter; (ii) unreasonable and material interference by Landlord or any Landlord Parties with the completion of the Tenant Improvements and which objectively preclude construction of Tenant Improvements by any person; and/or (iii) delays due to the acts or failures to act of Landlord or any Landlord Parties with respect to payment of the Tenant Improvement Allowance or the Additional TI Allowance, as applicable (to the extent Tenant is entitled to disbursement thereof pursuant to the terms and conditions of this Tenant Work Letter without dispute by Landlord) which result in a cessation of work upon the Tenant Improvements. If Tenant contends that a Landlord Caused Delay has occurred, Tenant shall notify Landlord in writing (a "Delay Notice") within two (2) business days of the date upon which the subject claimed delay becomes known to Tenant and/or Tenant's Architect or Tenant's Agents. If such actions, inaction or circumstances described in the notice set forth in the Delay Notice are not cured by Landlord within two (2) business days of receipt of the Delay Notice and if such actions, inaction or circumstances otherwise qualify as a Landlord Caused Delay, then a Landlord Caused Delay shall be deemed to have occurred commencing as of the expiration of such 2-business day period following the date of Landlord's receipt of the Delay Notice and ending as of the date such delay ends.

EXHIBIT B<br><br>-9- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788

SCHEDULE 1 TO EXHIBIT B

FORM OF AGREEMENT FOR ADDITIONAL MONTHLY BASE RENT

FIRST AMENDMENT TO LEASE

This FIRST AMENDMENT TO LEASE ("Amendment") is made and entered into as of ____________ ___, 202_, by and between ____________________________________ ("Landlord"), and _______________________________________ ("Tenant").

r e c i t a l s :

  • Landlord and Tenant are parties to that certain Lease dated ____ ___, 20___, (the "Lease"), pursuant to which Tenant leases premises on the ____________ floors (the "Premises") containing approximately ____________ rentable square feet of space in the building located at ___________________ (the "Building").
  • Landlord and Tenant desire to amend the Lease on the terms and conditions set forth in this Amendment.

a g r e E m e n t :

NOW, THEREFORE, in consideration of the foregoing recitals and the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:

  • Terms. All capitalized terms when used herein shall have the same respective meanings as are given such terms in the Lease unless expressly provided otherwise in this Amendment.
  • Additional TI Allowance. Pursuant to the terms of Section __ of the Tenant Work Letter attached to the Lease as Exhibit B, Tenant was entitled to an Additional TI Allowance of up to $_____________ (the "Additional TI Allowance"). Notwithstanding any provision to the contrary contained in the Lease, Landlord and Tenant hereby acknowledge and agree that Tenant has utilized _______________ and __/100 Dollars ($_______.__) of the Additional TI Allowance (the "Utilized Additional TI Allowance").
  • Additional Monthly Base Rent. As a result of Tenant's use of the Utilized Additional TI Allowance, Tenant is required to pay Additional Monthly Base Rent calculated as provided in Section 4 of the Tenant Work Letter, which Additional Monthly Base Rent shall be equal to $______ per month, payable on or before the first (1st) day of each month commencing as of ____________, and continuing through the expiration of the initial Lease Term.
  • [PROVIDE FOR ADDITIONAL SECURITY DEPOSIT OR LETTER OF CREDIT IF APPLICABLE]
  • No Further Modification. Except as specifically set forth in this Amendment, all of the terms and provisions of the Lease shall remain unmodified and in full force and effect.
EXHIBIT B<br><br>-10- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788

IN WITNESS WHEREOF, this Amendment has been executed as of the day and year first above written.

LANDLORD: TENANT:
By: By:
Name: Name:
Its: Its:
EXHIBIT B<br><br>-11- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
--- ---

SCHEDULE 2 TO EXHIBIT B

FORM OF ADDITIONAL TI ELECTION NOTICE

[Date]

[LANDLORD ADDRESS]

Re: Lease (the "Lease") between _______ ("Landlord") and ______ ("Tenant") dated ___________, 20__, for space (the "Premises") in the building located at ___________ (the "Building")<br><br>NOTICE OF ELECTION TO USE ADDITIONAL TENANT IMPROVEMENT ALLOWANCE

Dear [LANDLORD]:

The above referenced Tenant hereby (i) elects to use $______________ of the Additional Tenant Improvement Allowance granted to Tenant pursuant to the terms of Section ____ of the Tenant Work Letter attached as Exhibit B to the referenced Lease (such amount the "Elected Additional TI Allowance"), and (ii) agrees that Tenant will execute the Additional TI Amendment with respect thereto as provided in such Section ___.

If Tenant is a corporation, trust or partnership, each individual executing this letter on behalf of Tenant hereby represents and warrants that such person signing on behalf of Tenant is authorized to do so.

Very truly yours,

TENANT:

By:
Name:
Its:
EXHIBIT B<br><br>-12- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
--- ---

SCHEDULE 3 TO EXHIBIT B

APPROVED SPACE PLAN

img258108143_2.jpg

  • Tenant agrees that Tenant shall (i) carefully remove the “View Glass” panels and securely store the same in the underground parking area of the Building in an exact location as designated by Landlord, and (ii) cause the glass in the new sliding doors to match the finish of the View Glass in one of the middle shading tones.
EXHIBIT B<br><br>-13- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788

EXHIBIT C

DIRECTORS SCIENCE PARK

INTENTIONALLY OMITTED

EXHIBIT C<br><br>-1- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788

EXHIBIT D

DIRECTORS SCIENCE PARK

FORM OF TENANT'S ESTOPPEL CERTIFICATE

The undersigned as Tenant under that certain Lease (the "Lease") made and entered into as of ___________, 20___ by and between _______________ as Landlord, and the undersigned as Tenant, for Premises consisting of the [[entire office building]] located at ______________________________, [[California]], certifies as follows:

  • Attached hereto as Exhibit A is a true and correct copy of the Lease and all amendments and modifications thereto. The documents contained in Exhibit A represent the entire agreement between the parties as to the Premises.
  • The undersigned currently occupies the Premises described in the Lease, the Lease Term commenced on __________, and the Lease Term expires on ___________, and the undersigned has no option to terminate or cancel the Lease or to purchase all or any part of the Premises, the Building and/or the Project.
  • Base Rent became payable on ____________.
  • The Lease is in full force and effect and has not been modified, supplemented or amended in any way except as provided in Exhibit A.
  • Tenant has not transferred, assigned, or sublet any portion of the Premises nor entered into any license or concession agreements with respect thereto except as follows: ____________.
  • Tenant shall not modify the documents contained in Exhibit A without the prior written consent of Landlord's mortgagee.
  • All monthly installments of Base Rent, all Additional Rent and all monthly installments of estimated Additional Rent have been paid when due through ____________. The current monthly installment of Base Rent is $_____________________.
  • All conditions of the Lease to be performed by Landlord necessary to the enforceability of the Lease have been satisfied and Landlord is not in default thereunder. In addition, the undersigned has not delivered any notice to Landlord regarding a default by Landlord thereunder. Except as expressly provided in the Lease, the Lease does not require Landlord to provide any rental concessions or to pay any leasing brokerage commissions.
  • No rental has been paid more than thirty (30) days in advance and no security has been deposited with Landlord except as provided in the Lease. Neither Landlord, nor its successors or assigns, shall in any event be liable or responsible for, or with respect to, the retention, application and/or return to Tenant of any security deposit paid to any prior landlord of the Premises, whether or not still held by any such prior landlord, unless and until the party from whom the security deposit is being sought, whether it be a lender, or any of its successors or assigns, has actually received for its own account, as landlord, the full amount of such security deposit.
  • As of the date hereof, there are no existing defenses or offsets, or, to the undersigned's knowledge, claims or any basis for a claim, that the undersigned has against Landlord.
  • If Tenant is a corporation or partnership, each individual executing this Estoppel Certificate on behalf of Tenant hereby represents and warrants that Tenant is a duly formed and existing entity qualified to do business in California and that Tenant has full right and authority to execute and deliver this Estoppel Certificate and that each person signing on behalf of Tenant is authorized to do so.
EXHIBIT D<br><br>-1- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
  • There are no actions pending against the undersigned under the bankruptcy or similar laws of the United States or any state. There are no actions pending against the undersigned that, if determined or adjudicated adversely to the undersigned, could materially impair Tenant's ability to perform its obligations under the Lease, and as of the date hereof, no such adverse determination or judgment has been made.
  • Tenant is in full compliance with all federal, state and local laws, ordinances, rules and regulations affecting its use of the Premises, including, but not limited to, those laws, ordinances, rules or regulations relating to hazardous or toxic materials. Tenant has never permitted or suffered, nor does Tenant have any knowledge of, the generation, manufacture, treatment, use, storage, disposal or discharge of any hazardous, toxic or dangerous waste, substance or material in, on, under or about the Project or the Premises or any adjacent premises or property in violation of any federal, state or local law, ordinance, rule or regulation.
  • To the undersigned's knowledge, all tenant improvement work to be performed by Landlord under the Lease has been completed in accordance with the Lease and has been accepted by the undersigned and all reimbursements and allowances due to the undersigned under the Lease in connection with any tenant improvement work have been paid in full. All work (if any) in the common areas required by the Lease to be completed by Landlord has been completed and all parking spaces required by the Lease have been furnished and/or all parking ratios required by the Lease have been met.

The undersigned acknowledges that this Estoppel Certificate may be delivered to Landlord or to a prospective mortgagee or prospective purchaser, and acknowledges that said prospective mortgagee or prospective purchaser will be relying upon the statements contained herein in making the loan or acquiring the property of which the Premises are a part and that receipt by it of this certificate is a condition of making such loan or acquiring such property.

Executed at ______________ on the ____ day of ___________, 20__.

"Tenant":
,
a
By:
--- ---
Its:
By:
--- ---
Its:
EXHIBIT D<br><br>-2- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
--- ---

EXHIBIT E

DIRECTORS SCIENCE PARK

ENVIRONMENTAL QUESTIONNAIRE

ENVIRONMENTAL QUESTIONNAIRE FOR COMMERCIAL AND INDUSTRIAL PROPERTIES

Tenant Name:
Lease Address:
Lease Type (check correct box – right click to properties): Primary Lease/Lessee
Sublease from:

Instructions: The following questionnaire is to be completed by the Lessee representative with knowledge of the planned operations for the specified building/location. Please print clearly and attach additional sheets as necessary.

1.0 PROCESS INFORMATION

Describe planned site use, including a brief description of manufacturing processes and/or pilot plants planned for this site, if any.

2.0 HAZARDOUS MATERIALS – OTHER THAN WASTE

Will (or are) non-waste hazardous materials be/being used or stored at this site? If so, continue with the next question. If not, go to Section 3.0.

2.1 Are any of the following materials handled on the Property? ☐ Yes ☐ No

[A material is handled if it is used, generated, processed, produced, packaged, treated, stored, emitted, discharged, or disposed.] If YES, check (right click to properties) the applicable correct Fire Code hazard categories below.

Combustible dusts/fibers Explosives Flammable liquids
Combustible liquids (e.g., oils) Compressed gas - inert Flammable solids/pyrophorics
Cryogenic liquids - inert Compressed gas - flammable/pyrophoric Organic peroxides
Cryogenic liquids - flammable Compressed gas - oxidizing Oxidizers - solid or liquid
Cryogenic liquids - oxidizing Compressed gas - toxic Reactives - unstable or water reactive
Corrosives - solid or liquid Compressed gas - corrosive Toxics - solid or liquid

2-2. For all materials checked in Section 2.1 above, please list the specific material(s), use(s), and quantities of each used or stored on the site in the table below; or attach a separate inventory. NOTE: If proprietary, the constituents need not be named but the hazard information and volumes are required.

EXHIBIT E<br><br>-1- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
Material/<br><br>Chemical Physical<br><br>State (Solid,<br><br>Liquid, or<br><br>Gas) Container Size Number of Containers Used<br><br>& Stored Total Quantity Units (pounds for<br><br>solids,<br><br>gallons or<br><br>liters for<br><br>liquids, &<br><br>cubic feet for<br><br>gases)
--- --- --- --- --- ---

2-3. Describe the planned storage area location(s) for the materials in Section 2-2 above. Include site maps and drawings as appropriate.

2-4. Other hazardous materials. Check below (right click to properties) if applicable. NOTE: If either of the latter two are checked (BSL-3 and/or radioisotope/radiation), be advised that not all lease locations/cities or lease agreements allow these hazards; and if either of these hazards are planned, additional information will be required with copies of oversight agency authorizations/licenses as they become available.

Risk Group 2/Biosafety Level-2 Biohazards Risk Group 3/Biosafety Level-3 Biohazards Radioisotopes/Radiation

3.0 HAZARDOUS WASTE (i.e., REGULATED CHEMICAL WASTE)

Are (or will) hazardous wastes (be) generated? ☐ Yes ☐ No

If YES, continue with the next question. If not, skip this section and go to section 4.0.

EXHIBIT E<br><br>-2- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788

3.1 Are or will any of the following hazardous (CHEMICAL) wastes generated, handled, or disposed of (where applicable and allowed) on the property?

Liquids Process sludges PCBs
Solids Metals wastewater

3-2. List and estimate the quantities of hazardous waste identified in Question 3-1 above.

HAZARDOUS<br><br>(CHEMICAL)<br><br>WASTE<br><br>GENERATED SOURCE WASTE TYPE APPROX.<br><br>MONTHLY<br><br>QUANTITY<br><br>with units DISPOSITION [e.g., off-<br><br>site landfill, incineration,<br><br>fuel blending scrap metal;<br><br>wastewater neutralization<br><br>(onsite or off-site)]
RCRA<br><br>listed<br><br>(federal) Non-RCRA<br><br>(Calif-ornia<br><br>ONLY or<br><br>recycle)

3-3. Waste characterization by: Process knowledge ☐ EPA lab analysis ☐ Both ☐

3-4. Please include name, location, and permit number (e.g. EPA ID No.) for transporter and disposal facility if applicable. Attach separate pages as necessary. If not yet known, write "TBD."

Hazardous Waste<br><br>Transporter/Disposal<br><br>Facility Name Facility Location Transporter<br><br>(T) or Disposal<br><br>(D) Facility Permit Number

3-5. Are pollution controls or monitoring employed in the process to prevent or minimize the release of wastes into the environment? NOTE: This does NOT mean fume hoods; examples include air scrubbers, cyclones, carbon or HEPA filters at building exhaust fans, sedimentation tanks, pH neutralization systems for wastewater, etc.

☐ Yes ☐ No

If YES, please list/describe:

4.0 OTHER REGULATED WASTE (i.e., REGULATED BIOLOGICAL WASTE, referred to as "Medical Waste" in California)

4-1. Will (or do) you generate medical waste? ☐ Yes ☐ No If NO, skip to Section 5.0.

EXHIBIT E<br><br>-3- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788

4-2. Check the types of waste that will be generated, all of which fall under the California Medical Waste Act:

Contaminated sharps (i.e., if contaminated with ≥ Risk Group 2 materials) Animal carcasses Pathology waste known or suspected to be contaminated with ≥ Risk Group 2 pathogens)
Red bag biohazardous waste (i.e., with ≥ Risk Group 2 materials) for autoclaving Human or non-human primate blood, tissues, etc.<br><br>(e.g., clinical specimens) Trace Chemotherapeutic Waste and/or Pharmaceutical waste NOT otherwise regulated as RCRA chemical waste

4-3. What vendor will be used for off-site autoclaving and/or incineration?

4-5. Do you have a Medical Waste Permit for this site? ☐ Yes ☐ No, not required.

☐ No, but an application will be submitted.

5.0 UNDERGROUND STORAGE TANKS (USTS) & ABOVEGROUND STORAGE TANKS (ASTS)

5-1. Are underground storage tanks (USTs), aboveground storage tanks (ASTs), or associated pipelines used for the storage of petroleum products, chemicals, or liquid wastes present on site (lease renewals) or required for planned operations (new tenants)? ☐ Yes ☐ No

NOTE: If you will have your own diesel emergency power generator, then you will have at least one AST! [NOTE: If a backup generator services multiple tenants, then the landlord usually handles the permits.]

If NO, skip to section 6.0. If YES, please describe capacity, contents, age, type of the USTs or ASTs, as well any associated leak detection/spill prevention measures. Please attach additional pages if necessary.

UST or<br>AST Capacity<br>(gallons) Contents Year<br>Installed Type (Steel,<br>Fiberglass, etc.) Associated Leak<br>Detection / Spill<br>Prevention<br>Measures*

*NOTE: The following are examples of leak detection / spill prevention measures: integrity testing, inventory reconciliation, leak detection system, overfill spill protection, secondary containment, cathodic protection.

5-2. Please provide copies of written tank integrity test results and/or monitoring documentation, if available.

5-3. Is the UST/AST registered and permitted with the appropriate regulatory agencies? ☐ Yes ☐ No, not yet

If YES, please attach a copy of the required permit(s). See Section 7-1 for the oversight agencies that issue permits, with the exception of those for diesel emergency power generators which are permitted by the local Air Quality District (Bay Area Air Quality Management District = BAAQMD; or San Diego Air Pollution Control District = San Diego APCD).

EXHIBIT E<br><br>-4- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788

5-4. If this Questionnaire is being completed for a lease renewal, and if any of the USTs/ASTs have leaked, please state the substance released, the media(s) impacted (e.g., soil, water, asphalt, etc.), the actions taken, and all remedial responses to the incident.

5-5. If this Questionnaire is being completed for a lease renewal, have USTs/ASTs been removed from the Property?

☐ Yes ☐ No

If YES, please provide any official closure letters or reports and supporting documentation (e.g., analytical test results, remediation report results, etc.).

5-6. For Lease renewals, are there any above or below ground pipelines on site used to transfer chemicals or wastes?

☐ Yes ☐ No

For new tenants, are installations of this type required for the planned operations? ☐ Yes ☐ No

If YES to either question in this section 5-6, please describe.

6.0 ASBESTOS CONTAINING BUILDING MATERIALS

Please be advised that an asbestos survey may have been performed at the Property. If provided, please review the information that identifies the locations of known asbestos containing material or presumed asbestos containing material. All personnel and appropriate subcontractors should be notified of the presence of these materials, and informed not to disturb these materials. Any activity that involves the disturbance or removal of these materials must be done by an appropriately trained individual/contractor.

7.0 OTHER REGULATORY PERMITS/REQUIREMENTS

7-1. Does the operation have or require an industrial wastewater permit to discharge into the local National Pollutant Discharge Elimination System (NPDES)? [Example: This applies when wastewater from equipment cleaning is routed through a pH neutralization system prior to discharge into the sanitary or lab sewer for certain pharmaceutical manufacturing wastewater; etc.] Permits are obtained from the regional sanitation district that is treating wastewater.

☐ Yes ☐ No ☐ No, but one will be prepared and submitted to the Landlord property management company.

If so, please attach a copy of this permit or provide it later when it has been prepared.

7-2. Has a Hazardous Materials Business Plan (HMBP) been developed for the site and submitted via the State of California Electronic Reporting System (CERS)? [NOTE: The trigger limits for having to do this are ≥ 200 cubic feet if any one type of compressed gas(except for carbon dioxide and inert simple asphyxiant gases, which have a higher trigger limit of ≥ 1,000 cubic feet); ≥ 55 gallons if any one type

EXHIBIT E<br><br>-5- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788

of hazardous chemical liquid; and ≥500 pounds of any one type of hazardous chemical solid. So a full-sixe gas cylinder and a 260-liter of liquid nitrogen are triggers! Don't forget the diesel fuel in a backup emergency generator if the diesel tank size is ≥ 55 gallons and it is permitted under the tenant (rather than under the landlord).] NOTE: Each local Certified Unified Program Agency (CUPA) in California governs the HMBP process so start there. Examples: the CUPA for cities in San Mateo County is the County Environmental Health Department; the CUPA for the City of Hayward, CA is the Hayward Fire Department; the CUPA for Mountain View is the Mountain View Fire Department; and, the CUPA for San Diego is the County of San Diego Hazardous Materials Division (HMD),

☐ Yes ☐ No, not required. ☐ No, but one will be prepared and submitted, and a copy will be provided to the landlord property management company.

If one has been completed, please attach a copy. Continue to provide updated versions as they are completed. This is a legal requirement in that State law requires that the owner/operator of a business located on leased or rented real property shall notify, in writing, the owner of the property that the business is subject to and is in compliance with the Hazardous Materials Business Plan requirements (Health and Safety Code Chapter 6.95 Section 25505.1).

7-3. NOTE: Please be advised that if you are involved in any tenant improvements that require a construction permit, you will be asked to provide the local city with a Hazardous Materials Inventory Statement (HMIS) to ensure that your hazardous chemicals fall within the applicable Fire Code fire control area limits for the applicable construction occupancy of the particular building. The HMIS will include much of the information listed in Section 2-2. Neither the landlord nor the landlord's property management company expressly warrants that the inventory provided in Section 2-2 will necessarily meet the applicable California Fire Code fire control area limits for building occupancy, especially in shared tenant occupancy situations. It is the responsibility of the tenant to ensure that a facility and site can legally handle the intended operations and hazardous materials desired/ needed for its operations, but the landlord is happy to assist in this determination when possible.

CERTIFICATION

I am familiar with the real property described in this questionnaire. By signing below, I represent and warrant that the answers to the above questions are complete and accurate to the best of my knowledge. I also understand that Lessor will rely on the completeness and accuracy of my answers in assessing any environmental liability risks associated with the property.

Signature:
Name:
Title:
Date:
Telephone:
EXHIBIT E<br><br>-6- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
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EXHIBIT F

DIRECTORS SCIENCE PARK

AVAILABLE BUILDING SYSTEMS CAPACITIES

  • House Compressed Air - Landlord has installed and shall provide to Tenant non-exclusive pro rata access to the to the following house compressed air system: POWEREX LSO-05A5-SPL OPEN SCROLL OCTOPLEX 5HP PUMPS WITH PREMIUM CONTROLS. 100SCFM AT 145PSIG, 200 GALLON TANK SIZE, 97,600BTU/H, 80dB LEVEL, 460V, 52.6 F.L.A.. Tenant shall be responsible for providing distribution from the existing compressed air system to the Premises.
  • House Vacuum - Landlord has installed and shall provide to Tenant non-exclusive pro rata access to the to the following house vacuum system: POWEREX LVPT-0505-EAP-SPL LUBRICATED VANE VACUUM TRIPLEX 5HP PUMPS WITH PREMIUM CONTROL, 111SCFM AT 19"Hg EACH, 200GAL TANK, 32,514BTU/H, 77dB LEVEL, 460V, 21.4 F.L.A., WEIGHT 2,100LBS. PROVIDE WITH SEE THRU LIQUID SEPARATOR SOLBERG #STS-300C, Tenant shall be responsible for providing distribution from the existing vacuum system to the Premises.
  • House Generator - Landlord has installed and shall provide to Tenant non-exclusive pro rata access to the to the existing 750kW emergency generator. Tenant shall be responsible for providing the necessary electrical distribution from the emergency generator to the Premises.
  • HVAC - Landlord has installed and shall provide to Tenant access to the mechanical infrastructure described in the sub-bullets below. Tenant shall be responsible for providing the distribution of supply and return air to and from the existing infrastructure and within the Premises.
  • The existing 37,500 cfm Aaon RZA-200 AHU with MERV 14 filtration to serve lab spaces with 100% outside air, up to 7,250 cfm.
  • The existing LG VRF Fan Coil and Condenser Units] to serve the office space.
  • The existing 75,000 cfm Strobic M54 exhaust fans on the roof for lab exhaust up to 7,250 cfm.
  • The existing 21,500 cmf Greenheck USF-30 general exhaust fans on the roof for office exhaust.
EXHIBIT F<br><br>-1- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788

EXHIBIT G

DIRECTORS SCIENCE PARK

TENANT RESERVED PARKING LOCATIONS

img258108143_3.jpg

EXHIBIT G<br><br>-1- Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788

LEASE

DIRECTORS SCIENCE PARK

HCP LIFE SCIENCE REIT, INC., a Maryland corporation

as Landlord,

and

KURA ONCOLOGY, INC.,

a Delaware corporation,

as Tenant.

Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788

TABLE OF CONTENTS

Page
1. PREMISES, BUILDING, PROJECT, AND COMMON AREAS 1
2. LEASE TERM; OPTION TERM; EARLY TERMINATION RIGHT 4
3. BASE RENT 7
4. ADDITIONAL RENT 7
5. USE OF PREMISES 15
6. SERVICES AND UTILITIES 20
7. REPAIRS 22
8. ADDITIONS AND ALTERATIONS 23
9. COVENANT AGAINST LIENS 26
10. INSURANCE 27
11. DAMAGE AND DESTRUCTION 29
12. NONWAIVER 31
13. CONDEMNATION 31
14. ASSIGNMENT AND SUBLETTING 32
15. SURRENDER OF PREMISES; OWNERSHIP AND REMOVAL OF TRADE FIXTURES 35
16. HOLDING OVER 37
17. ESTOPPEL CERTIFICATES; FINANCIAL STATEMENTS 37
18. SUBORDINATION 38
19. DEFAULTS; REMEDIES 38
20. COVENANT OF QUIET ENJOYMENT 42
21. SECURITY DEPOSIT 42
22. COMMUNICATIONS AND COMPUTER LINES 42
23. SIGNS 42
24. COMPLIANCE WITH LAW 43
25. LATE CHARGES 44
26. LANDLORD'S RIGHT TO CURE DEFAULT; PAYMENTS BY TENANT 44
27. ENTRY BY LANDLORD 44
28. TENANT PARKING 45
29. MISCELLANEOUS PROVISIONS 46
EXHIBITS
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A OUTLINE OF PREMISES
A-1 PROJECT SITE PLAN
B TENANT WORK LETTER
C INTENTIONALLY OMITTED
D FORM OF TENANT'S ESTOPPEL CERTIFICATE
E ENVIRONMENTAL QUESTIONNAIRE
F AVAILABLE BUILDING SYSTEMS CAPACITIES
G TENANT RESERVED PARKING LOCATIONS
(i) Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
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Page(s)
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Abatement Event 41
Additional Allowable Costs Exhibit B
Additional Notice 41
Additional Payment Commencement Date Exhibit B
Additional Rent 7
Additional TI Allowance Exhibit B
Additional TI Allowance Payment Exhibit B
Additional TI Amendment Exhibit B
Advocate Arbitrators 6
Affiliate 35
Alterations 23
Amendment Exhibit B
Amenity Space 2
Applicable Expense Year 12
Applicable Laws 43
Approved Space Plan Exhibit B
Approved Working Drawings Exhibit B
Architect Exhibit B
ATIA Election Notice Exhibit B
Audit Period 15
Base Building 23
Base Rent 7
Base Rent Abatement 7
bona-fide third-party offer 3
Brokers 50
Builder's Risk 24
Building 2
Building Hours 21
Building Security Features 26
Building Structure 23
Building Systems 23
Café 2
Casualty 29
Clean-up 19
Closure Letter 19
Code 32, Exhibit B
Common Areas 2
Comparable Buildings 5
Comparable Transactions 5
Concessions 5
Contemplated Effective Date 34
Contemplated Transfer Space 34
Contract Exhibit B
Contractor Exhibit B
Controllable Expenses 12
(ii) Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
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Page(s)
--- ---
Cosmetic Alterations 23
Delay Notice Exhibit B
Direct Expenses 8
Early Termination Right 6
Economic Terms 3
Elected Additional TI Allowance Exhibit B
Emergency Generator 22
Energy Disclosure Requirements 22
Engineers Exhibit B
Environmental Assessment 18
Environmental Laws 17
Environmental Questionnaire 16
Environmental Report 19
Estimate 14
Estimate Statement 14
Estimated Direct Expenses 14
Event of Default 38
Existing Hazardous Materials 18
Expense Year 8
Extension Option 2
Fair Rental Value 5
FF&E Exhibit B
Final Budget Exhibit B
Final Retention Exhibit B
Final Working Drawings Exhibit B
First Class Life Sciences Projects 3
Force Majeure 47
Future SNDA 38
Hazardous Materials 16
Hazardous Materials Claims 17
Holdover Damage Period Exhibit B
Holdover Damages Exhibit B
Holdover Payment Date Exhibit B
Holidays 21
HVAC 21
Inducement Provisions 40
Initial Notice 41
Intention to Transfer Notice 34
Interest Rate 44
Landlord 1
Landlord Caused Delay Exhibit B
Landlord Parties 27
Landlord Repair Notice 30
Landlord's Recapture Notice 34
Lease 1
Lease Commencement Date 4
(iii) Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
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Page(s)
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Lease Expiration Date 4
Lease Month 4
Lease Term 4
Lease Year 4
Lines 42
Losses 27
Mail 48
Management Fee Cap 11
Material Adverse Judgments 46
Mortgage 38
Mortgagee 38
Net Worth 35
Neutral Accountant 15
Neutral Arbitrator 6
Nine Month Period 34
Notices 48
Objectionable Name 43
OFAC 52
Operating Expenses 8
Option Rent 5
Option Term 2
Original Improvements 28
Original Tenant 1
Outside Agreement Date 5
Outside Holdover Penalty Date Exhibit B
Outside LCD 1
Outside Possession Date 1
Over-Allowance Amount Exhibit B
Patriot Act 52
PCBs 16
Permitted Assignee 4
Permitted Capital Costs 9
Permitted Transfer 35
Permitted Transferee 35
PMA Exhibit B
Possession Date 1
Premises 1
Prohibited Persons 52
Project 2
Proposition 13 13
Referee Sections 49
Refusal Exercise Notice 3
Refusal Notice 3
Refusal Space 2
Refusal Space Amendment 3
REIT Owner 32
(iv) Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
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Page(s)
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Release 16
Released 16
Releases 16
Rent 7
Rooftop Equipment 25
RSF 1
Scheduled Surrender Date Exhibit B
Second Chance Economic Terms 3
Second Chance Notice 3
Security Deposit 41
Security System 26
Sign Specifications 42
Site Plan 1
Statement 13
Subject Space 32
Substantial Completion Exhibit B
Summary 1
Superior Right Holders 3
Tax Expenses 12
Tenant 1
Tenant Change Request Exhibit B
Tenant Damage 1
Tenant Delays 2
Tenant Energy Use Disclosure 22
Tenant Improvement Allowance Items Exhibit B
Tenant Improvements Exhibit B
Tenant Parties 27
Tenant Signage 42
Tenant Work Letter 1
Tenant's Accountant 15
Tenant's Agents 16, Exhibit B
Tenant's Existing Space Exhibit B
Tenant's Share 13
Termination Date 6
Termination Fee 7
Termination Notice 6
Transfer Notice 32
Transfer Premium 33
Transferee 32
Transfers 32
TRIPLE net 8
Underlying Documents 9
Warranty Period 1
worth at the time of award 40
(v) Directors Science Park<br><br>Kura Oncology<br><br>COID: 24788
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EX-19.1

Exhibit 19.1

  • Introduction

This Insider Trading Policy of Kura Oncology, Inc. (the “Company”) applies to all directors, officers, other employees, consultants and certain designated contractors of the Company and any subsidiaries. It also applies to their family members who reside with them, anyone else who lives in their households and any family members who do not live in their households but whose transactions in the Company’s securities are directed by, or subject to, the influence or control of a director, officer, other employee, consultant or contractor of the Company.

  • Purpose

The purpose of this Insider Trading Policy (this “Policy”) is to clarify the circumstances under which trading in the stock of the Company or another publicly-traded company with which the Company has business dealings (each, a “Third Party”) by the Company’s directors, officers, other employees, consultants and contractors will result in civil liability and criminal penalties, as well as disciplinary action by the Company.

  • POLICY
  • During the course of your employment or service with the Company, you may receive important information that is not yet publicly available, i.e., not disclosed to the public in a press release or filing with the Securities and Exchange Commission (“Inside Information”), about the Company or a Third Party. Because of your access to this information, you may be in a position to profit financially by buying or selling or in some other way dealing in the Company’s or a Third Party’s stock, or to disclose such information to a third party who does so (known as a “Tippee”).
  • It is illegal for anyone to use Inside Information to gain personal benefit, or to pass on, or “tip,” the information to someone who does so. There is no de minimis exception to this rule. Use of Inside Information to gain personal benefit and tipping are as illegal with respect to a few shares of stock as they are with respect to a large number of shares. You can be held liable both for your own transactions and for transactions effected by a Tippee, or even a Tippee of a Tippee. Furthermore, it is important that the appearance as well as the act of insider trading in stock be avoided.
  • Exceptions

Please note that, generally, transactions directly with the Company, i.e., option exercises or purchases under the Company’s employee stock purchase plan, will not create problems. However, the subsequent sale or other disposition of such stock is fully subject to these restrictions. In addition, purchases or sales pursuant to a written plan that meets the requirements of Rule 10b5-1 under the Securities Exchange Act of 1934, as amended, may be made without restriction provided that the plan was adopted in accordance with Company policies, including the Company’s Rule 10b5-1 Trading Plan Policy.

  • Inside Information

  • As a practical matter, it is sometimes difficult to determine whether you possess Inside Information. The key to determining whether nonpublic information you possess about a public company is Inside Information is whether dissemination of the information would be likely to affect the market price of the company’s stock or would be likely to be considered important by investors who are considering trading in that company’s stock. Certainly, if the information makes you want to trade, it would probably have the same effect on others. Both positive and negative information can be material. If you possess Inside Information about a company, you must refrain from trading in that company’s stock, advising anyone else to do so or communicating the information to anyone else until you know that the information has been disseminated to the public. This means that in some circumstances, you may have to forego a proposed transaction in a company’s securities even if you planned to execute the transaction prior to learning of the inside information and even though you believe you will suffer an economic loss or sacrifice an anticipated profit by waiting. “Trading” includes engaging in short sales, transactions in put or call options, hedging transactions and other inherently speculative transactions.

  • Additionally, you may not discuss material nonpublic information about the Company with anyone outside the Company. This prohibition covers spouses, family members, friends, business associates, or persons with whom we are doing business (except to the extent that such persons are covered by a non-disclosure agreement and the discussion is necessary to accomplisha business purpose of the Company). You may not participate on Internet forums, message boards, social media sites, “chat rooms” or in other electronic discussions on the Internet concerning the activities of the Company or other companies with which the Company does business, even if you do so anonymously.

  • Although this is by no means an exhaustive list, information about the following items may be considered to be Inside Information until it is publicly disseminated:

  • regulatory developments;

  • clinical developments;

  • financial results or forecasts;

  • major new products or product candidates;

  • establishment of, or developments in, strategic partnerships, joint ventures or similar collaborations;

  • communications with government agencies;

  • strategic plan

  • potential mergers, acquisitions, tender offers or the sale of assets of the Company or a subsidiary thereof;

  • significant write-offs;

  • potential acquisitions of additional product candidates or technologies;

  • notice of issuance of patents or the acquisition of other material intellectual property rights or other significant intellectual property developments;

  • significant changes or developments in the biopharmaceutical industry or technological innovations;

  • new major contracts, orders, suppliers, or finance sources, or the loss thereof;

  • significant changes or developments in supplies;

  • significant pricing changes;

  • events regarding the Company’s securities (e.g., defaults on senior securities, calls of securities for redemption, repurchase plans, stock splits, public or private equity/debt offerings, or changes in Company dividend policies or amounts);

  • significant changes in control or senior management;

  • significant changes in compensation policy;

  • bankruptcies or receiverships;

  • actual or threatened major litigation, or a major development in or the resolution of such litigation; and

  • change in auditors or a notification that the Company can no longer rely on an auditor’s report.

  • Prohibition of Speculative Trading

No director, officer, other employee, consultant or designated contractor of the Company may engage in short sales, transactions in put or call options, hedging transactions or other inherently speculative transactions with respect to the Company’s stock at any time. In addition, no director, officer, other employee, consultant or designated contractor of the Company may margin, or make any offer to margin, or otherwise pledge as security, any of the Company’s stock, including without limitation, borrowing against such stock, at any time.

  • Window Period Policy

Because the officers, directors and certain other designated employees of the Company are the most visible to the public and are most likely, in the view of the public, to possess Inside Information about the Company, we ask them to do more

than refrain from insider trading. Under a separate policy applicable to this group of individuals known as the Company’s Window Period Policy, the Company’s directors, officers and other employees are required to limit their transactions in the Company’s stock to defined time periods following public dissemination of quarterly and annual financial results, notify one or more designated pre-clearance individuals prior to engaging in transactions in the Company’s stock and observe other restrictions designed to minimize the risk of apparent or actual insider trading.

  • Application

  • Anyone who effects transactions in the Company’s or a Third Party’s stock (or provides information to enable others to do so) on the basis of Inside Information is subject to both civil liability and criminal penalties, including imprisonment, as well as disciplinary action by the Company, up to and including termination for cause.

  • This Insider Trading Policy will continue to apply to your transactions in the Company’s or a Third Party’s stock even after your employment or service with the Company has terminated. If you are in possession of material nonpublic information when your employment or service terminates, you may not trade in the Company’s stock until the information has become public or is no longer material.

  • A director, officer, other employee, consultant or contractor who has questions about these matters should speak with his or her own attorney or to the Company’s Chief Legal Officer.

  • Any director, officer, other employee, consultant or designated contractor of the Company who knows of or suspects a violation of this Insider Trading Policy should report the violation immediately to the Company’s Chief Legal Officer or through the procedures for anonymous reporting outlined in the Company’s Code of Business Conduct and Ethics. The Company and any subsidiaries will comply with all requests from the U.S. Securities and Exchange Commission, the Nasdaq Stock Market, Inc. and other agencies for information related to insider trading investigations.

    EX-23.1

Exhibit 23.1

Consent of Independent Registered Public Accounting Firm

We consent to the incorporation by reference in the following Registration Statements:

  • Registration Statement (Form S-3 Nos. 333-275279 and 333-276995) of Kura Oncology, Inc.,
  • Registration Statement (Form S-8 Nos. 333-203504, 333-210260 and 333-263000) pertaining to the Amended and Restated 2014 Equity Incentive Plan and the 2015 Employee Stock Purchase Plan of Kura Oncology, Inc., and
  • Registration Statement (Form S-8 Nos. 333-216683, 333-223591, 333-230075, 333-236621 333-253441, 333-269974 and 333-272389) pertaining to the Amended and Restated 2014 Equity Incentive Plan of Kura Oncology, Inc.;

of our reports dated February 28, 2025, with respect to the financial statements of Kura Oncology, Inc. and the effectiveness of internal control over financial reporting of Kura Oncology, Inc. included in this Annual Report (Form 10-K) of Kura Oncology, Inc. for the year ended December 31, 2024.

/s/ Ernst & Young LLP

San Diego, California

February 28, 2025

EX-31.1

Exhibit 31.1

CERTIFICATION 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

I, Troy E. Wilson, Ph.D., J.D., certify that:

  • I have reviewed this Annual Report on Form 10-K of Kura Oncology, Inc.;
  • 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;
  • 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;
  • I am 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:
  • Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me by others within those entities, particularly during the period in which this report is being prepared;
  • Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my 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;
  • Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report my 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
  • 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
  • I have disclosed, based on my 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):
  • 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
  • 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: February 28, 2025 By: /s/ Troy E. Wilson, Ph.D., J.D.
Troy E. Wilson, Ph.D., J.D.
President and Chief Executive Officer<br><br>(Principal Executive and Financial Officer)

EX-32.1

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Annual Report of Kura Oncology, Inc. (the “Company”) on Form 10-K for the period ended December 31, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), Troy E. Wilson, Ph.D., J.D., as President and Chief Executive Officer of the Company, hereby certifies, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that to the best of his knowledge:

  • The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
  • The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: February 28, 2025 By: /s/ Troy E. Wilson, Ph.D., J.D.
Troy E. Wilson, Ph.D., J.D.
President and Chief Executive Officer<br><br>(Principal Executive and Financial Officer)

This certification accompanies the Annual Report on 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 Kura Oncology, Inc. 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 Annual Report on Form 10-K), irrespective of any general incorporation language contained in such filing.