As filed with the Securities and Exchange Commission on November 27, 2017
Registration No. 333-221533
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
AMENDMENT No. 1
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
Odonate Therapeutics, LLC
(to be converted into Odonate Therapeutics, Inc.)
(Exact name of registrant as specified in its charter)
Delaware | 2834 |
46-2248457 |
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(State or other jurisdiction of incorporation or organization) |
(Primary Standard Industrial Classification Code Number) |
(I.R.S. Employer Identification Number) |
4747 Executive Drive, Suite 510
San Diego, CA 92121
(858) 731-8180
(Address, including zip code, and telephone number, including
area code, of registrants principal executive offices)
Kevin C. Tang
Chairman and Chief Executive Officer
Odonate Therapeutics, LLC
4747 Executive Drive, Suite 510
San Diego, CA 92121
(858) 731-8180
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
With copies to:
Ryan A. Murr Andrew K. Hirsch Gibson, Dunn & Crutcher LLP 555 Mission Street San Francisco, CA 94105 (415) 393-8373 |
Mark V. Roeder Brian D. Paulson Latham & Watkins LLP 140 Scott Drive Menlo Park, CA 94025 (650) 328-4600 |
Approximate date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective.
If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☐
If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of large accelerated filer, accelerated filer, smaller reporting company and emerging growth company in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
Non-accelerated filer | ☒ (Do not check if a smaller reporting company) | 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 to Section 7(a)(2)(B) of the Securities Act. ☒
CALCULATION OF REGISTRATION FEE
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Title of Each Class of Securities to be Registered |
Amount to be Registered (1) |
Proposed Maximum Offering Price Per Share (2) |
Proposed Maximum Aggregate Offering Price (2) |
Amount of Registration Fee (3) |
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Common Stock, par value $0.01 per share |
6,762,000 | $27.00 | $182,574,000 | $22,731 | ||||
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(1) | Includes 882,000 additional shares that the underwriters have the option to purchase from the registrant, if any. See Underwriting. |
(2) | Estimated solely for purposes of calculating the registration fee in accordance with Rule 457(a) under the Securities Act of 1933, as amended. |
(3) | The registrant previously paid filing fees of $21,476 in connection with a previous filing of its registration statement on Form S-1 (File No. 333-221533), which registration statement contemplated a proposed maximum offering price of $172,500,000. |
The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to such Section 8(a), may determine.
The information in this prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
Subject to Completion, dated November 27, 2017.
5,880,000 Shares
Common Stock
This is an initial public offering of shares of common stock of Odonate Therapeutics, Inc. All of the 5,880,000 shares of common stock are being sold by the company.
Prior to this offering, there has been no public market for the common stock. It is currently estimated that the initial public offering price per share will be between $24.00 and $27.00. We have applied to list our common stock on the NASDAQ Global Select Market under the symbol ODT.
We are an emerging growth company as defined under the federal securities laws and, as such, may elect to comply with certain reduced public company reporting requirements in future reports after the closing of this offering. See BusinessImplications of Being an Emerging Growth Company.
See Risk Factors beginning on page 11 to read about factors you should consider before buying shares of the common stock.
Neither the Securities and Exchange Commission nor any other regulatory body have approved or disapproved these securities, or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.
Per Share | Total | |||||||
Initial public offering price |
$ | $ | ||||||
Underwriting discount (1) |
$ | $ | ||||||
Proceeds, before expenses, to us |
$ | $ |
(1) | See Underwriting beginning on page 116 for additional information regarding underwriting compensation. |
To the extent that the underwriters sell more than 5,880,000 shares of common stock, the underwriters have the option to purchase up to an additional 882,000 shares from Odonate Therapeutics, Inc. at the initial price to public, less the underwriting discount.
Existing stockholders affiliated with our directors have indicated an interest in purchasing approximately $25.0 million of shares of our common stock in this offering at the initial public offering price.
The underwriters expect to deliver the shares against payment in New York, New York on , 2017.
Goldman Sachs & Co. LLC |
Jefferies |
Cowen
Prospectus dated , 2017.
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Material U.S. Federal Income Tax Consequences to Non-U.S. Holders |
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F-1 |
You should rely only on the information contained in this prospectus or in any free-writing prospectus we may authorize to be delivered or made available to you. We have not, and the underwriters have not, authorized anyone to provide you with additional or different information, and we take no responsibility for and cannot provide any assurance as to the reliability of any other information others may give you. We are not, and the underwriters are not, making an offer to sell shares of our common stock in any jurisdiction where the offer or sale is not permitted. The information in this prospectus or any free-writing prospectus is accurate only as of its date, regardless of its time of delivery or of any sale of shares of our common stock. Our business, financial condition, results of operations and prospects may have changed since that date.
For investors outside the United States: We have not, and the underwriters have not, done anything that would permit this offering, or possession or distribution of this prospectus, in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the shares of common stock and the distribution of this prospectus outside of the United States.
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This summary highlights selected information contained elsewhere in this prospectus. This summary does not contain all of the information that you should consider before deciding to invest in our common stock, which we refer to in this prospectus as common stock. You should read the entire prospectus carefully, including Risk Factors , Managements Discussion and Analysis of Financial Condition and Results of Operations and our financial statements and notes to those financial statements, before making an investment decision. Some of the statements in this summary constitute forward-looking statements. See Special Note Regarding Forward-Looking Statements. In this prospectus, unless context requires otherwise, references to we, us, our, Odonate or the Company refer to: (i) Odonate Therapeutics, LLC before the completion of the Conversion described below; and (ii) Odonate Therapeutics, Inc. as of and following the completion of the Conversion. Additionally, references to our Board refer to: (i) prior to the date of the Conversion, the board of directors of Odonate Therapeutics, LLC; and (ii) following the date of the Conversion, the board of directors of Odonate Therapeutics, Inc.
Our Company
We are a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer. Our initial focus is on the development of tesetaxel, a novel chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several potential therapeutic advantages over currently available taxanes, including: oral administration with a low pill burden and a patient-friendly dosing regimen; a formulation that does not contain solubilizing agents that are known to cause hypersensitivity (allergic) reactions; and improved activity against chemotherapy-resistant tumors. Tesetaxel has been generally well tolerated in clinical studies and has demonstrated robust single-agent antitumor activity in two Phase 2 studies in patients with locally advanced or metastatic breast cancer (MBC). We expect to begin enrolling patients in our multinational, multicenter, randomized, Phase 3 study in MBC, known as CONTESSA, in the fourth quarter of 2017 and report top-line results from this study in 2020. Our goal for tesetaxel is to develop an effective chemotherapy choice for patients that provides quality-of-life advantages over current alternatives.
Breast Cancer and Its Treatment
Breast cancer is the second-most common cancer worldwide, with an estimated 1.8 million new cases diagnosed per year. In Europe, an estimated 494,000 new cases are diagnosed and approximately 143,000 women will die of the disease each year, making it the leading cause of cancer death in women. In the U.S., an estimated 255,000 new cases are diagnosed and approximately 41,000 women will die of the disease each year, making it the second-leading cause of cancer death in women.
Breast cancer typically is staged (Stage 0-IV) based on the size of the tumor, whether or not the tumor is invasive, whether or not the cancer is in the lymph nodes, and whether or not the cancer has spread (metastasized) to other parts of the body beyond the breast. For most patients diagnosed with early breast cancer who undergo surgical treatment, the prognosis is good; the 5-year survival rate for these patients is approximately 94%. However, the prognosis for patients with MBC (which includes patients who relapsed following surgery as well as patients who are inoperable upon initial diagnosis) remains poor; the 5-year survival rate for metastatic disease is approximately 22%, making MBC an area of continued, high unmet medical need.
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Breast cancer is a heterogeneous disease comprised of several molecular subtypes, which are commonly grouped into clinical subtypes based on receptor status. Human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive disease, which represents the majority of all MBC cases, remains an area of high unmet medical need. Over the past two decades, only modest survival benefits have been achieved in this patient population; hence, treatment goals emphasize controlling disease-related symptoms, minimizing toxicity and maximizing quality-of-life. Patients with HER2 negative, HR positive MBC are typically treated with endocrine therapy (with or without targeted agents such as a cyclin-dependent kinase (CDK) 4/6 inhibitor), chemotherapy, or both.
Endocrine agents, which target certain hormone receptors inside and on the surface of tumor cells with the goal of slowing tumor growth, are generally preferred as initial treatment prior to chemotherapy for most patients with HER2 negative, HR positive MBC. The recently approved CDK 4/6 inhibitor palbociclib, an orally administered therapy, has significantly improved outcomes for patients with MBC when used in combination with endocrine agents. However, virtually all MBC patients on endocrine therapy will eventually progress and require subsequent treatment with chemotherapy.
Chemotherapy agents currently available for the treatment of HER2 negative, HR positive MBC, including the preferred agents, capecitabine and the approved taxanes, paclitaxel, nab-paclitaxel and docetaxel, generally are limited by their toxicity and negative impact on quality-of-life. Paclitaxel, the most commonly used taxane in the treatment of MBC, is formulated with a solubilizing agent known to cause hypersensitivity reactions, is associated with significant side effects such as alopecia (hair loss) and peripheral neuropathy (weakness, numbness and/or pain from damage to the nerves), and, like all currently available taxanes, must be administered intravenously, typically at an infusion center. These infusion center visits generally are required weekly and are several hours in duration. Therapies given intravenously at an infusion center often are associated with:
| Fear of needles and associated complications; |
| Anxiety, including institutional-triggered side effects such as nausea and vomiting; |
| Heightened awareness of life-threatening disease presence; and |
| Disruption of daily activities. |
Capecitabine is orally administered and therefore offers quality-of-life advantages over intravenously delivered chemotherapies. However, capecitabine requires a large pill burden and a challenging dosing schedule. Thus, there is a need for new agents that, when given alone or in combination with other agents, have robust antitumor activity and are better tolerated and easier to take.
Tesetaxel: A Chemotherapy with Potential Best-in-Class Properties
Tesetaxel, which we believe will qualify as a New Chemical Entity (NCE) if and when a New Drug Application (NDA) is submitted, retains the same taxane core as the approved taxanes, but is chemically designed to: be highly orally bioavailable; have a long elimination half-life; be highly soluble; and retain activity against chemotherapy-resistant tumor cells. We believe that tesetaxels unique properties may translate into significant benefits for patients. These may include:
| Oral administration with a low pill burden and a patient-friendly dosing regimen; |
| A formulation that does not contain solubilizing agents contained in other taxane formulations known to cause hypersensitivity reactions; and |
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| Durable antitumor activity. |
We believe that an all-oral regimen, such as tesetaxel monotherapy or tesetaxel plus capecitabine, that may delay the need to receive intravenous chemotherapy in an infusion center will be preferred by patients.
Tesetaxel Clinical Experience
More than 500 patients were treated with tesetaxel between 2001 and 2012 across 22 clinical studies. Tesetaxel was administered as monotherapy in 16 studies and in combination with other chemotherapy agents in 6 studies. Final study data are available for 8 of these studies, while data collection, which was interrupted due to the prior sponsors lack of funding, is underway for 14 of these studies. Tesetaxel has demonstrated single-agent antitumor activity in multiple tumor types, including MBC, gastric cancer, colorectal cancer and non-small cell lung cancer. In MBC, tesetaxel was shown to have robust single-agent antitumor activity in two multicenter, Phase 2 studies.
| In Study TOB203, which was conducted by Genta Incorporated from 2010 to 2012, 46 patients with HER2 negative MBC were enrolled to receive, as first-line chemotherapy, tesetaxel administered orally at 27 mg/m 2 (of body surface area: an average female cancer patient is approximately 1.7m 2 ) on the first day of a 21-day cycle, with escalation to 35 mg/m 2 in subsequent cycles depending on tolerability, without anti-allergy premedication. Forty-four (44) of 46 patients received at least one tumor scan and, therefore, were evaluable for response. The confirmed (based on two tumor scans at least 4 weeks apart in time) objective response rate (ORR) (complete response (disappearance of all target lesions) + partial response (at least a 30% decrease in the sum of the diameters of target lesions)) was 36% (16 of 44 patients, including one with a complete response). Median progression-free survival (PFS) (time from initiation of therapy to tumor progression or death) was 5.8 months among all treated patients and 7.3 months in patients with HR positive disease. Tesetaxel was generally well tolerated. The most common Grade ³ 3 (severe or serious) adverse event (AE) was neutropenia (low level of neutrophils, a type of white blood cell), which occurred in 26% of patients receiving 27 mg/m 2 , the dose we chose for our Phase 3 study. Also at this dose, there were no cases of Grade ³ 3 peripheral neuropathy, and the incidence of Grade 2 alopecia (significant hair loss) was 15%. |
| In Study 927E-PRT005, which was conducted by Daiichi Sankyo Company, Limited (Daiichi Sankyo) from 2004 to 2006, 34 patients with MBC were enrolled to receive, as first-, second- or third-line chemotherapy, tesetaxel administered orally at initial doses of 27 mg/m 2 (79% of patients) or 35 mg/m 2 (21% of patients) on the first day of a 21-day cycle. Thirty-two (32) patients completed at least one course of therapy and were included in the efficacy population. The confirmed ORR was 22% (7 of 32 patients; all partial responses). Median time-to-progression (time from initiation of therapy to tumor progression) was 3.4 months. Tesetaxel was generally well tolerated. The most common Grade ³ 3 AE was neutropenia, which occurred in 35% of patients. The incidence of Grade ³ 3 peripheral sensory neuropathy (numbness and/or pain from damage to the nerves) was 3%, and the incidence of Grade 2 alopecia was 18%. |
CONTESSA: A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel in MBC
We are initiating a 600-patient, multinational, multicenter, randomized, Phase 3 study, known as CONTESSA, that will compare tesetaxel (27 mg/m 2 on the first day of a 21-day cycle) plus a reduced dose of capecitabine (1,650 mg/m 2 /day on days 114 of a 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m 2 /day on days 114 of a 21-day cycle) in patients with HER2 negative,
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HR positive MBC previously treated with a taxane in the neoadjuvant (prior to surgery) or adjuvant (immediately following surgery) setting. Where indicated, patients must have received an anthracycline and/or endocrine therapy with or without a CDK 4/6 inhibitor. CONTESSAs primary endpoint is PFS assessed by an Independent Radiologic Review Committee (IRC). CONTESSAs secondary endpoints are overall survival, ORR assessed by IRC, disease control rate (ORR + prolonged ( ³ 24 weeks) stable disease) assessed by IRC and patient reported outcomes (PROs).
In designing CONTESSA, we received non-binding advice from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). We believe CONTESSA may serve as a single pivotal study sufficient for product registration, provided that the study demonstrates a statistically significant and clinically meaningful improvement in the primary endpoint, PFS, for tesetaxel plus a reduced dose of capecitabine as compared to the approved dose of capecitabine alone as well as an overall favorable benefit-risk profile for the tesetaxel plus a reduced dose of capecitabine regimen. Generally, a single pivotal study can be sufficient for FDA approval only when the study provides highly reliable and statistically strong evidence of an important clinical benefit and in which confirmation of the result in a second clinical trial would be practically or ethically impossible. There can be no assurance that the outcome of CONTESSA will be sufficient for the approval of tesetaxel by the FDA, EMA or other regulatory agencies or that tesetaxel will be approved at all. We expect to begin enrolling patients in CONTESSA in the fourth quarter of 2017. Our U.S. Investigational New Drug application was originally filed by Daiichi Sankyo in 2001 for the treatment of cancer and is active, and we plan to submit clinical trial applications in countries outside of the U.S. in which we plan to enroll patients.
CONTESSA is designed to evaluate whether tesetaxel plus a reduced dose of capecitabine results in improved PFS with manageable toxicity and favorable quality-of-life compared to the approved dose of capecitabine alone. Tesetaxel plus a reduced dose of capecitabine incorporates two agents with synergistic mechanisms of action and is an all-oral regimen that requires a pill burden that is approximately 30% less than the approved dose of capecitabine alone. Our rationale for the CONTESSA study design includes the following points.
| Capecitabine is a preferred agent as a first- or second-line chemotherapy treatment for patients with HER2 negative, HR positive MBC. Therefore, capecitabine, at the approved dose, is an appropriate control regimen for a registration-enabling Phase 3 study. |
| There is a high unmet medical need for combination chemotherapy regimens with improved benefit-risk profiles. |
| Combining the approved dose of capecitabine with currently available taxanes results in improved efficacy but with significant toxicity. |
| Preclinical and clinical studies support investigating whether reducing the dose of capecitabine in combination with a taxane will reduce toxicity without a reduction in efficacy. |
| Single-agent tesetaxel has demonstrated antitumor activity in two Phase 2 studies in MBC. |
| In a Phase 1 study, the combination of tesetaxel plus a reduced dose of capecitabine was associated with a tolerable AE profile, with minimal overlapping toxicity. |
We believe that these factors support the investigation of tesetaxel plus a reduced dose of capecitabine as a novel, all-oral regimen with a potentially favorable benefit-risk profile for the treatment of patients with HER2 negative, HR positive MBC.
Daiichi Sankyo License and Our Intellectual Property
In 2013, we licensed rights to tesetaxel in all major markets from Daiichi Sankyo, the original inventor of the product. The intellectual property portfolio protecting our tesetaxel program includes 9 U.S., 4 European and 7 Japanese patents, as well as two pending U.S. patent applications and one
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pending European patent application. We believe that tesetaxel will qualify as an NCE if and when an NDA is submitted. If tesetaxel qualifies as an NCE, we believe that NCE regulatory exclusivity, combined with our intellectual property, assuming the availability of 5 years of patent term restoration under the Hatch-Waxman Act, will provide exclusivity for tesetaxel in all major markets through at least 2031.
Risks Associated with Our Business
Investing in our common stock involves significant risks. You should carefully consider the risks described in Risk Factors before making a decision to invest in our common stock. If we are unable to successfully address these risks and challenges, our business, financial condition or results of operations would be materially adversely affected. In such case, the trading price of our common stock would likely decline, and you may lose all or part of your investment. Below is a summary of some of the principal risks we face.
| We are substantially dependent on our ability to successfully develop and commercialize tesetaxel. |
| The commercial adoption of tesetaxel and any other product candidates we develop will depend on the degree of their market acceptance. |
| We have only limited assets and will need to raise additional capital before we can expect to generate revenue or become profitable. |
| We have never generated any revenue and may never be profitable. |
| We currently have no sales, marketing or distribution capabilities. If we elect to commercialize tesetaxel ourselves and we are unable to establish effective sales, marketing or distribution capabilities or if we are unable to enter into agreements with third parties to commercialize tesetaxel or other product candidates that we may develop, we may not be able to effectively generate product revenues. |
| Because a number of companies compete with us, many of which have greater resources than we do, and because we face rapid changes in science in our industry, we cannot be certain that our products will be accepted in the marketplace or capture market share. |
| Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, reduce the commercial attractiveness of a prescribing label or result in significant negative consequences following regulatory approval, if approved. |
| We may not be successful in our efforts to identify, in-license or acquire, discover, develop or commercialize additional product candidates. |
| We will need to increase the size and capabilities of our organization, and we may experience difficulties in managing our growth. |
| Our future success depends on our ability to retain our key executives and to attract, retain and motivate qualified personnel. |
| Drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies may not be predictive of future study results. |
| Results from any future clinical studies we may undertake may not be sufficient to obtain regulatory approvals to market our product candidates on a timely basis, if at all. |
| Future clinical studies that we may undertake may be delayed or halted. |
| Even if we obtain regulatory approval for tesetaxel or another product candidate, our products will remain subject to regulatory scrutiny. |
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| If we are unable to achieve and maintain coverage and adequate levels of reimbursement for tesetaxel and other product candidates, if approved, their commercial success may be severely hindered. |
| We will be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and health information privacy, security laws and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties. |
| Recently enacted and future legislation may increase the difficulty and cost of obtaining regulatory approval, and the subsequent commercialization, of our product candidates, if approved, and may affect the prices we may obtain. |
| Governments outside the U.S. tend to impose strict price controls, which may adversely affect our revenues, if any. |
| We rely on third parties to conduct our preclinical and clinical studies. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed. |
| If the third-party manufacturers on which we rely fail to produce our product candidates on a timely basis, or comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the studies, regulatory submissions, required approvals or commercialization of our product candidates. |
| Our success in developing and marketing our product candidates depends significantly on our ability to obtain and maintain patent protection and operate without infringing on the rights of others. |
| The scope and terms of our patents may be insufficient to protect our product candidates for an adequate amount of time. |
| If the FDA or foreign regulatory authorities approve generic versions of any of our products that receive marketing approval or such authorities do not grant our products appropriate periods of exclusivity before approving generic versions of our products, the sales of our products could be adversely affected. |
| If we fail to comply with our obligations under our licenses, we may lose rights to critical patents that are important to the commercialization and revenue potential of tesetaxel. |
| If our product candidates infringe the rights of others, we could be subject to expensive litigation, become liable for substantial damages, be required to obtain licenses from others or be prohibited from selling our product candidates altogether. |
| Patent policy and rule changes could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. |
| In addition to patent protection, we will need to successfully preserve our trade secrets. If we are unable to maintain effective proprietary rights for tesetaxel or any future product candidates, we may not be able to compete effectively in our markets. |
| There is no existing market for our common stock and we do not know if one will develop. Even if a market does develop, the stock prices in the market may not exceed the offering price. |
| The price of our common stock may be volatile, and you may lose all or part of your investment. |
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| Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud. |
| Future sales of our common stock, or the perception that such sales may occur, could depress our common stock price. |
| We have broad discretion as to the use of proceeds from this offering and may not use the proceeds effectively. |
| Because we do not expect to pay dividends in the foreseeable future, you must rely on price appreciation of our common stock for return on your investment. |
| If you purchase shares of our common stock sold in this offering, you will incur immediate and substantial dilution. |
| Our directors, executive officers and principal stockholders will continue to have substantial control over the Company after this offering, which could limit your ability to influence the outcome of key transactions, including a change of control. |
| We are an emerging growth company, as defined in the Securities Act, and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our common stock less attractive to investors. |
Corporate Conversion
We are currently a Delaware limited liability company named Odonate Therapeutics, LLC, and we have operated our business through this Delaware limited liability company. In connection with this offering, prior to the effectiveness of the registration statement of which this prospectus forms a part, we will convert from a Delaware limited liability company into a Delaware corporation by filing a certificate of conversion with the Delaware Secretary of State, and we will change our name from Odonate Therapeutics, LLC to Odonate Therapeutics, Inc. (the Conversion). After converting to a corporation and changing our name to Odonate Therapeutics, Inc., we will be governed by a certificate of incorporation to be filed with the Delaware Secretary of State and our bylaws. Upon the effectiveness of the Conversion, the members of the Board of Odonate Therapeutics, LLC will become the members of the Board of Odonate Therapeutics, Inc., and the officers of Odonate Therapeutics, LLC will become the officers of Odonate Therapeutics, Inc. References throughout this prospectus to our stockholders include the holders of stock that is offered and sold in this offering, as well as holders of Odonate Therapeutics, LLC common and incentive units that are converted into shares of Odonate Therapeutics, Inc. common stock as a result of the Conversion.
Corporate Information
Odonate Therapeutics, LLC was originally formed as a Delaware limited liability company under the laws of the State of Delaware in March 2013 and will be converted to a corporation in connection with this offering pursuant to the Conversion. Our corporate office is located at 4747 Executive Drive, Suite 510, San Diego, CA 92121, and our telephone number is (858) 731-8180. Our website is www.odonate.com . The information on, or that can be accessed through, our website is not part of this prospectus and is not incorporated by reference herein.
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Common stock offered by us |
5,880,000 shares. | |
Common stock to be outstanding immediately after this offering |
26,520,356 shares. |
|
Option to purchase additional shares of common stock |
The underwriters have a 30-day option to purchase up to 882,000 additional shares of common stock. |
|
Use of proceeds |
We expect that our net proceeds from this offering will be approximately $137.1 million, at an assumed public offering price of $25.50 per share of common stock, the midpoint of the range set forth on the cover of this prospectus, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. We intend to use the proceeds of the offering for development and regulatory activities relating to tesetaxel, including the conduct of our Phase 3 study, CONTESSA, working capital and general corporate purposes. See Use of Proceeds for additional information. | |
Risk factors |
You should carefully read and consider the information set forth in the Risk Factors, together with all of the other information set forth in this prospectus, before deciding whether to invest in our common stock. | |
Proposed NASDAQ Global Select Market symbol |
ODT |
The number of shares of common stock to be outstanding after this offering excludes:
| 4,800,000 shares of common stock reserved for future grant or issuance under our 2017 Stock Option Plan, which will become effective prior to the completion of this offering; and |
| 500,000 shares of common stock reserved for future issuance under our 2017 Employee Stock Purchase Plan, which will become effective prior to the completion of this offering. |
Additionally, unless otherwise expressly stated or the context otherwise requires, the information in this prospectus assumes:
| the 2-for-1 forward split of our common units and incentive units, which became effective on November 26, 2017; |
| the completion of the Conversion; |
| no exercise of the underwriters option to purchase 882,000 additional shares of our common stock; and |
| the effectiveness of our certificate of incorporation and bylaws in connection with the completion of this offering. |
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The following selected statements of operations data for the years ended December 31, 2015 and 2016 are for Odonate Therapeutics, LLC prior to the completion of the Conversion and are derived from our audited financial statements included elsewhere in this prospectus. The selected statements of operations data for the nine months ended September 30, 2016 and 2017 and the balance sheet data as of September 30, 2017 are for Odonate Therapeutics, LLC prior to the completion of the Conversion and are derived from our unaudited interim financial statements included elsewhere in this prospectus. In our opinion, these unaudited interim financial statements have been prepared on a basis consistent with our audited financial statements and contain all adjustments, consisting only of normal and recurring adjustments, necessary for a fair presentation of such financial data.
The historical results presented below are not necessarily indicative of the results to be expected for any future period. This information should be read in conjunction with Risk Factors, Capitalization, Managements Discussion and Analysis of Financial Condition and Results of Operations, Selected Financial Data and our financial statements and the related notes included elsewhere in this prospectus. Our financial statements are prepared in accordance with generally accepted accounting principles in the U.S. (GAAP).
Year Ended
December 31, |
Nine Months Ended
September 30, |
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2015 | 2016 | 2016 | 2017 | |||||||||||||
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Statements of Operations Data: |
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Operating expenses: |
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Research and development |
$ | - | $ | 2,622 | $ | 856 | $ | 14,862 | ||||||||
General and administrative |
158 | 463 | 283 | 2,136 | ||||||||||||
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Total operating expenses |
158 | 3,085 | 1,139 | 16,998 | ||||||||||||
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Net loss attributable to common unitholders |
$ | (158 | ) | $ | (3,085 | ) | $ | (1,139 | ) | $ | (16,998 | ) | ||||
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Net loss per unit attributable to common unitholders: |
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Basic and diluted |
$ | (0.17 | ) | $ | (0.54 | ) | $ | (0.27 | ) | $ | (1.37 | ) | ||||
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Weighted average units outstanding: |
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Basic and diluted |
923 | 5,762 | 4,290 | 12,427 | ||||||||||||
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As-converted net loss per share (unaudited): (1) |
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Basic and diluted |
$ | (0.54 | ) | $ | (1.36 | ) | ||||||||||
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As-converted weighted average shares outstanding (unaudited): (1) |
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Basic and diluted |
5,762 | 12,515 | ||||||||||||||
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(1) | Reflects the completion of the Conversion, without giving effect to the issuance of shares from this offering. |
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As of September 30, 2017 | ||||||||
Actual | As-adjusted (1) | |||||||
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Selected Balance Sheet Data: |
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Cash |
$ | 74,504 | $ | 211,822 | ||||
Working capital |
72,264 | 210,150 | ||||||
Total assets |
76,515 | 213,047 | ||||||
Total liabilities |
3,331 | 2,763 | ||||||
Accumulated deficit |
(23,546 | ) | (23,546 | ) | ||||
Total members/stockholders equity |
73,184 | 210,284 |
(1) | As-adjusted to reflect the Conversion and $137.1 million in proceeds from the issuance and sale of 5,880,000 shares of our common stock in this offering, based on an assumed public offering price of $25.50 per share, the midpoint of the range set forth on the cover of this prospectus and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. |
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An investment in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below before deciding whether to purchase shares of our common stock. In assessing these risks, you should also refer to the other information contained in this prospectus, including our financial statements and related notes and Managements Discussion and Analysis of Financial Condition and Results of Operations. Our business, financial condition, results of operations, cash flow and prospects could be materially and adversely affected by any of these risks or uncertainties. In any such case, the trading price of our common stock could decline, and you could lose all or part of your investment.
Risks Related to Our Business
We are substantially dependent on our ability to successfully develop and commercialize tesetaxel.
Since our inception, we have invested substantially all of our capital resources on the development of tesetaxel, which we initially are developing for the treatment of locally advanced or metastatic breast cancer (MBC). We intend to initiate a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC who have received no more than one chemotherapy regimen for advanced disease and have received a taxane in the neoadjuvant (prior to surgery) or adjuvant (immediately following surgery) setting. If the results of this study, known as CONTESSA, are negative or inconclusive, we may be unable to obtain regulatory approval for tesetaxel. Further, even if the results of CONTESSA are positive, we cannot assure you that the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authority will approve tesetaxel for marketing.
Our ability to generate revenue and our future success depends in large part on the success of CONTESSA, the approval of tesetaxel, the nature of any potential requirements for post-approval studies and the successful commercialization of tesetaxel, if approved. Delays in obtaining regulatory approval for tesetaxel would, among other consequences, require further development expenditures, delay the launch of tesetaxel and impact our ability to raise additional capital, all of which would have a material adverse effect on our business and financial condition.
The commercial adoption of tesetaxel and any other product candidates we develop will depend on the degree of their market acceptance.
Even with the requisite approvals from the FDA, the EMA and other regulatory authorities, the commercial adoption of tesetaxel and any other product candidates we develop will depend on the degree of their acceptance by physicians, patients, third-party payors and others in the medical community. The degree of market acceptance will depend on a number of factors, including:
| the safety and efficacy of the product as demonstrated in clinical studies; |
| the perception of physicians, patients, third-party payors and others in the medical community of the relative safety, efficacy, convenience, effect on quality-of-life and cost-effectiveness of the product, compared to those of other available treatments; |
| the products prescribing label, including the description of the products approved indication(s), the description of its efficacy, including the endpoints in which it showed an improvement, and the prevalence and severity of any side effects, including any limitations or warnings arising therefrom; |
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| the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; |
| the strength of marketing and distribution support and timing of market introduction of competitive products; |
| the publicity concerning our products or competing products and treatments; |
| product liability litigation alleging injuries relating to our products or similar classes of drugs; |
| our ability to access third parties to manufacture or distribute our products on acceptable terms or at all; |
| any post-approval study requirements for our products and the results thereof; and |
| sufficient third-party insurance coverage and reimbursement. |
Even if a potential product such as tesetaxel displays a favorable efficacy and safety profile in preclinical and clinical studies, market acceptance of the product is not fully known until after its commercial launch. Our efforts to educate physicians, patients, third-party payors and others in the medical community on the benefits of our product candidates may require significant resources and may never be successful. If tesetaxel or other product candidates are approved but fail to achieve an adequate level of acceptance by physicians, patients, third-party payors and others in the medical community, we will not be able to generate sufficient revenue to become or remain profitable.
We have only limited assets and will need to raise additional capital before we can expect to generate revenue or become profitable.
As of September 30, 2017, we had no revenue, an accumulated deficit of $23.5 million and available cash of $74.5 million. We believe that our existing cash as of September 30, 2017 and the estimated net proceeds from this offering will be sufficient to meet our anticipated cash requirements through at least the next 24 months. However, to fund future operations to the point at which we are able to generate positive cash flow from sales of tesetaxel or other potential product candidates, we will need to raise significant additional capital. The amount and timing of future funding requirements will depend on many factors, including the timing and results of our ongoing development efforts, the potential expansion of our current development programs, potential new development programs and related general and administrative support. We anticipate that we will seek to fund our operations through public and private equity and debt financings or other sources, such as potential licenses or other collaboration agreements. We cannot assure you that anticipated additional financing will be available to us on favorable terms, or at all. Although we have been successful in obtaining financing through the issuance of our equity securities, we cannot assure you that we will be able to do so in the future. If we are unable to raise additional capital to fund our clinical development and commercialization of tesetaxel, if approved, and other business activities, we could be forced to abandon one or more programs and curtail or cease our operations.
We have never generated any revenue and may never be profitable.
We have no products approved for marketing, have never generated any revenue from product sales and have incurred losses in each year since our inception. Our ability to generate revenue and achieve profitability depends on our ability, alone or with marketing partners, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize, tesetaxel. We expect to continue to incur losses for the foreseeable future, and we anticipate these losses will increase as we continue to develop tesetaxel. Our ability to generate revenue from product sales depends heavily on our success in many areas, including but not limited to:
| successfully completing the development of tesetaxel; |
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| obtaining regulatory approvals to market tesetaxel; |
| successfully managing third-party service providers involved in the manufacturing and development of tesetaxel; |
| successfully commercializing tesetaxel, either independently or with marketing partners; |
| obtaining market acceptance of tesetaxel, including garnering market share from existing and future treatment alternatives; |
| negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter; |
| maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; and |
| attracting, hiring and retaining qualified personnel. |
If tesetaxel or any other product candidates we may develop are approved for marketing, we anticipate incurring significant commercialization costs. Our expenses could increase beyond our current expectations if we are required by the FDA, the EMA or other regulatory authorities to change our manufacturing processes or quality procedures or perform additional or unanticipated preclinical, clinical or other studies. In cases where we are successful in obtaining regulatory approvals to market tesetaxel or other product candidates, our revenue will be dependent, in part, on the size of the markets in the territories for which we gain regulatory approval, the acceptance of the price of the product in those markets and the ability to obtain reimbursement at any price. If the number of our addressable patients is not as significant as we estimate, the indication approved by regulatory authorities is narrower than we expect or the reasonably accepted population for treatment is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of such products, even if approved. If we are not able to generate revenue from the sale of approved products, we may never become profitable.
We currently have no sales, marketing or distribution capabilities. If we elect to commercialize tesetaxel ourselves and we are unable to establish effective sales, marketing or distribution capabilities or if we are unable to enter into agreements with third parties to commercialize tesetaxel or other product candidates that we may develop, we may not be able to effectively generate product revenues.
We currently do not have sales, marketing or distribution capabilities. In order to commercialize tesetaxel, if approved, or any other product candidates that we may develop, we must build marketing, sales and distribution capabilities or make arrangements with third parties to perform these services, and we may not be successful in doing so. If tesetaxel receives regulatory approval and we decide to commercialize tesetaxel ourselves, building the requisite sales, marketing or distribution capabilities will be expensive and time-consuming and will require significant attention of our leadership team to manage. Any failure or delay in the development of our sales, marketing or distribution capabilities would adversely impact the commercialization of any product. The competition for talented individuals experienced in selling and marketing pharmaceutical products is intense, and we cannot assure you that we can assemble an effective team. Additionally, we may choose to collaborate, either globally or on a territory-by-territory basis, with third parties on the commercialization of tesetaxel or any other product candidates that we may develop. If we are unable to enter into such arrangements on acceptable terms or at all, we may not be able to successfully commercialize any of our product candidates that receive regulatory approval or any such commercialization may experience delays or limitations.
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We may be subject to additional risks related to operating in foreign countries either ourselves or through a third-party, including:
| differing regulatory requirements in foreign countries; |
| unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements; |
| economic weakness, including inflation or political instability in particular foreign economies and markets; |
| compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; |
| foreign taxes, including withholding of payroll taxes; |
| foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country; |
| difficulties staffing and managing foreign operations; |
| workforce uncertainty in countries where labor unrest is more common than in the U.S.; |
| potential liability under the Foreign Corrupt Practices Act of 1977 or comparable foreign regulations; |
| challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the U.S.; |
| production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and |
| business interruptions resulting from geopolitical actions, including war and terrorism. |
If we are not successful in commercializing tesetaxel or other product candidates, our future product revenue will suffer and we may incur significant additional losses.
Because a number of companies compete with us, many of which have greater resources than we do, and because we face rapid changes in science in our industry, we cannot be certain that our products will be accepted in the marketplace or capture market share.
Competition from other biotechnology and pharmaceutical companies is intense and is expected to increase. A number of companies are pursuing the development of pharmaceuticals in oncology, our area of focus. Many of these companies are very large, and have financial, technical, sales and distribution and other resources substantially greater than ours. The greater resources of these competitors may enable them to develop, obtain regulatory approval for or market competing products more quickly or effectively, making it extremely difficult for us to capture a share of the market for our products. Additionally, the biotechnology and pharmaceutical industries are subject to rapid changes in science, and our competitors may develop and market products with improved therapeutic profiles relative to our product candidates that would render our product candidates noncompetitive.
Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, reduce the commercial attractiveness of a prescribing label or result in significant negative consequences following regulatory approval, if approved.
Clinical studies of tesetaxel or other product candidates we may develop could reveal a high and unacceptable incidence and severity of undesirable side effects. Undesirable side effects could
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adversely affect patient enrollment in clinical studies, cause us or regulatory authorities to interrupt, delay or halt clinical studies or result in the delay, denial or withdrawal of regulatory approval by the FDA, the EMA or other regulatory authorities. For example, in 2007, tesetaxel was placed on clinical hold by the FDA while in development by the original sponsor due to the occurrence of several fatalities in the setting of severe neutropenia (a low level of neutrophils, a type of white blood cell) in patients with advanced cancer. While this clinical hold was lifted in 2008, and tesetaxel has since been evaluated in multiple clinical studies in 300 patients without any interruption due to safety issues, we cannot assure you that safety-related interruptions in tesetaxels clinical development will not occur again in the future. Any such recurrence could potentially delay or prevent the ultimate approval of the product candidate. Undesirable or adverse side effects also could result in regulatory authorities mandating a more restrictive prescribing label for the product, which, in turn, could limit the market acceptance of the product even if approved for marketing and commercialization.
Drug-related side effects could result in potential product liability claims. We carry product liability insurance in the amount of $10.0 million in the aggregate. We believe our product liability insurance coverage is sufficient in light of our clinical programs; however, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts or maintain coverage at all to protect us against losses due to liability. A successful product liability claim or series of claims brought against us could cause our stock price to decline and, if judgments exceed our insurance coverage, could adversely affect our results of operations, business and financial condition. In addition, regardless of merit or eventual outcome, product liability claims may result in impairment of our business reputation, withdrawal of clinical study participants, costs due to related litigation, distraction of managements attention from our primary business, initiation of investigations by regulators, substantial monetary awards to patients or other claimants, the inability to commercialize our product candidates and decreased demand for our product candidates, if approved for marketing.
Additionally, if one or more of our product candidates receives regulatory approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including but not limited to:
| the withdrawal of approvals by regulatory authorities; |
| the requirement of additional warnings on the prescribing label; |
| the requirement of a Risk Evaluation and Mitigation Strategy (REMS) plan, which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for healthcare providers and/or other elements to assure safe use; |
| litigation and the potential to be held liable for harm caused to patients; and |
| an adverse effect on our reputation. |
Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate and could significantly harm our business, results of operations, financial condition and prospects.
We may not be successful in our efforts to identify, in-license or acquire, discover, develop or commercialize additional product candidates.
Although a substantial amount of our effort will focus on the development and potential commercialization of tesetaxel, we also may seek to identify, in-license or acquire, discover, develop and commercialize additional product candidates in the oncology field. We cannot assure you that our efforts to in-license or acquire additional product candidates will be successful. Even if we are successful in in-licensing or acquiring additional product candidates, their requisite development activities may require substantial resources, and we cannot assure you that these development activities will result in regulatory approvals.
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We will need to increase the size and capabilities of our organization, and we may experience difficulties in managing our growth.
Odonate was formed in 2013 and, as of the date of this prospectus, had 50 employees. As we advance the development of tesetaxel, we must continue to grow the size of the organization. Future growth will impose significant added responsibilities on members of management, including:
| identifying, recruiting, integrating, retaining and motivating additional employees; |
| effectively managing our development efforts, including the clinical development and FDA, EMA or other regulatory authority review processes for our product candidates; |
| effectively managing our third-party service providers involved in the development and manufacture of our product candidates; and |
| improving our operational, financial and management controls, reporting systems and procedures. |
Our future financial performance and our ability to successfully develop and commercialize our product candidates will depend, in part, on our ability to effectively manage any future growth. Our management will have to dedicate a significant amount of its attention to managing these growth activities. In addition, we expect to incur additional costs in hiring, training and retaining such additional personnel.
If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully execute the tasks necessary to further develop and commercialize our product candidates and, accordingly, may not achieve our research, development and commercialization goals.
Our future success depends on our ability to retain our key executives and to attract, retain and motivate qualified personnel.
We are highly dependent on the principal members of our management and scientific teams. We do not maintain key person insurance for any of our executives or other employees. The loss of the services of any of these persons could impede the achievement of our research, development and commercialization objectives.
To induce valuable employees to remain at our company, in addition to salary and cash incentives, we have provided equity award grants that vest over time. The value to employees of these equity grants that vest over time may be significantly affected by changes in the price of our common stock that are beyond our control, and may at any time be insufficient to retain employees who receive more lucrative offers from other companies. Any of our employees could leave our employment at any time, with or without notice.
Recruiting and retaining qualified scientific, clinical, manufacturing and sales and marketing personnel or consultants will also be critical to our success. We rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our discovery, development and commercialization strategies. The loss of the services of any of our executive officers, key employees or consultants could impede the achievement of our research, development and commercialization objectives and seriously harm our ability to successfully implement our business strategy.
Replacing executive officers, key employees or consultants 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
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products. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these key personnel or consultants on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel.
We may hire part-time employees or use consultants. As a result, certain of our employees, officers, directors or consultants may not devote all of their time to our business, and may from time to time serve as employees, officers, directors and consultants of other companies.
Risks Related to Our Industry
Drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies may not be predictive of future study results.
Clinical testing is expensive, can take many years to complete and its outcome is inherently uncertain. Failure can occur at any time during the clinical study process. The results of preclinical studies and early clinical studies of our product candidates may not be predictive of the results of later-stage clinical studies. Product candidates that have shown promising results in early-stage clinical studies may still suffer significant setbacks in subsequent clinical studies. For example, the safety or efficacy results generated to date in our clinical studies do not ensure that later clinical studies will demonstrate similar results. There is a high failure rate for pharmaceutical product candidates proceeding through clinical studies, and product candidates in later stages of clinical studies may fail to show the desired safety and efficacy, despite having progressed through preclinical studies and initial clinical studies.
A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical studies due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier studies. Moreover, preclinical and clinical data often are susceptible to varying interpretations and analyses. We do not know whether any clinical studies we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain regulatory approval to market our product candidates.
Results from any future clinical studies we may undertake may not be sufficient to obtain regulatory approvals to market our product candidates on a timely basis, if at all.
Pharmaceutical product candidates are subject to extensive government regulations related to development, clinical studies, manufacturing and commercialization. In order to sell any product that is under development, we must first receive regulatory approval. To obtain regulatory approval, we must conduct preclinical and clinical studies that demonstrate that our product candidates are safe and effective. The process of obtaining FDA, EMA and other regulatory authority approvals is costly, time-consuming, uncertain and subject to unanticipated delays.
The FDA, EMA and other regulatory authorities have substantial discretion in the approval process and may not agree that we have demonstrated that our product candidates are safe and effective. If our product candidates are ultimately not found to be safe and effective, we would be unable to obtain regulatory approval to manufacture, market and sell them. We can provide no assurances that the FDA, EMA or other regulatory authorities will approve our product candidates or, if approved, what the scope of the approved indication might be.
Future clinical studies that we may undertake may be delayed or halted.
Any clinical studies of our product candidates that we may conduct in the future, including CONTESSA, may be delayed or halted for various reasons, including:
| insufficient financial resources; |
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| insufficient supplies of drug product to treat the patients in the studies; |
| failure of patients to enroll in the studies at the rate we expect; |
| ineffectiveness of the product candidates; |
| patients experiencing unexpected side effects or other safety concerns being raised during treatment; |
| changes in governmental regulations or administrative actions; |
| failure to conduct studies in accordance with required clinical practices; |
| inspection of clinical study operations or study sites by the FDA or other regulatory authorities, resulting in a clinical hold; |
| political unrest at foreign clinical sites; or |
| natural disasters at any of our clinical sites. |
If studies are delayed or halted, we may incur significant additional expenses, and the potential approval of our product candidates may be delayed, which would have a material adverse effect on our business and financial condition.
Even if we obtain regulatory approval for tesetaxel or another product candidate, our products will remain subject to regulatory scrutiny.
If tesetaxel or other product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, efficacy and other post-market information.
Manufacturers and manufacturers facilities are required to comply with extensive FDA, EMA and other regulatory authority requirements, including ensuring that quality control and manufacturing procedures conform to current Good Manufacturing Practices (cGMP) regulations. As such, we and our contract manufacturers will be subject to continual review and inspections to assess compliance with cGMPs and adherence to commitments made in any New Drug Application (NDA), Market Authorization Application (MAA) or other marketing application. Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control.
Any regulatory approvals we receive for our product candidates may be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical studies, which must comply with applicable Good Clinical Practice (GCP) regulations. We could also be asked to conduct post-marketing clinical studies to verify the safety and efficacy of our products in general or in specific patient subsets. If initial regulatory approval was obtained via the accelerated approval pathway, we could be required to conduct a successful post-marketing clinical study to confirm clinical benefit for our products. An unsuccessful post-marketing study or failure to complete such a study could result in the withdrawal of regulatory approval. We will be required to report certain adverse reactions and production problems, if any, to the FDA, EMA and other regulatory authorities. Any new legislation addressing drug safety or approval issues could result in delays in product development or commercialization, or increased costs to assure compliance. We will have to comply with requirements concerning advertising and promotion for our products. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the products approved label. As such, we may not promote our products for
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indications or uses for which they do not have approval. The holder of an approved NDA or MAA must submit new or supplemental applications and obtain approval for certain changes to the approved product, product labeling or manufacturing process.
If a regulatory authority discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling of a product, such regulatory authority may impose restrictions on that product or us. If we fail to comply with applicable regulatory requirements, a regulatory or enforcement authority may, among other things:
| issue warning or untitled letters; |
| impose civil or criminal penalties; |
| suspend or withdraw regulatory approval; |
| suspend any of our ongoing clinical studies; |
| refuse to approve pending applications or supplements to approved applications submitted by us; |
| impose restrictions on our and our contract manufacturers operations, including closing manufacturers facilities; |
| seize or detain products; or |
| require a product recall. |
Any government investigation of alleged violations of law could require us to expend significant time and resources in response, and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercialize and generate revenue from our products. If regulatory sanctions are applied or if regulatory approval is withdrawn, this would have a material adverse effect on our business and financial condition.
If we are unable to achieve and maintain coverage and adequate levels of reimbursement for tesetaxel and other product candidates, if approved, their commercial success may be severely hindered.
Successful sales of tesetaxel and any other product candidates that may receive regulatory approval depend on the availability of coverage and adequate reimbursement from third-party payors. Patients who are prescribed medications for the treatment of their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their prescription drugs. Coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors is critical to new product acceptance. Coverage decisions may depend on clinical and economic standards that disfavor new products when more established or lower cost therapeutic alternatives are already available or subsequently become available. Assuming we obtain coverage for a given product, the resulting reimbursement payment rates might not be adequate or may require co-payments that patients find unacceptably high. Patients are unlikely to use our products unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our products.
The market for tesetaxel and any other product candidates that we attempt to commercialize will depend significantly on access to third-party payors drug formularies, or lists of medications for which third-party payors provide coverage and reimbursement. The industry competition to be included in such formularies often leads to downward pricing pressures on pharmaceutical products. Also, third-party payors may refuse to include a particular branded drug in their formularies or otherwise restrict patient access through formulary controls or otherwise to a branded drug when a less costly generic equivalent or other alternative is available.
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Third-party payors, whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In addition, in the U.S., no uniform policy requirement for coverage and reimbursement for products exists among third-party payors. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.
Third-party coverage and reimbursement for our product candidates for which we may receive regulatory approval may not be available or adequate in either the U.S. or international markets, which could have a material adverse effect on our business, results of operations, financial condition and prospects.
We will be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and health information privacy, security laws and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
Our operations may be directly, or indirectly through our customers, subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute, the federal False Claims Act and physician sunshine laws and regulations. These laws will impact, among other things, our clinical development, proposed sales, marketing and education programs. In addition, we may be subject to patient privacy regulation by both the federal government and the states in which we conduct our business. The U.S. laws that will affect our ability to operate include:
| the federal Anti-Kickback Statute, which prohibits, among other things, persons from soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs; |
| federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid or other third-party payors that are false or fraudulent; |
| federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; |
| HIPAA, as amended by the federal Health Information Technology for Economic and Clinical Health Act and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information; |
| the federal physician sunshine requirements under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, (collectively, the PPACA), which require manufacturers of drugs, devices, biologics and medical supplies to report annually to the U.S. Department of Health and Human Services information related to payments and other transfers of value to physicians, other healthcare providers and teaching hospitals, and ownership and investment interests held by physicians and other healthcare providers and their immediate family members and applicable group purchasing organizations; and |
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state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including |
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commercial insurers; state laws to comply with the pharmaceutical industrys voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. |
Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available thereunder, it is possible that some of our business activities could be subject to challenge under one or more of such laws. In addition, recent healthcare reform legislation has strengthened these laws. For example, the PPACA, among other things, amended the previous intent requirement of the federal Anti-Kickback Statute and criminal healthcare fraud statutes. Now, a person or entity does not have to have actual knowledge of the statutes or specific intent to violate them. The PPACA also provides that the federal government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.
If our operations are found to be in violation of any of these laws or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, imprisonment, disgorgement, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements and oversight if a person becomes subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, 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.
Recently enacted and future legislation may increase the difficulty and cost of obtaining regulatory approval, and the subsequent commercialization, of our product candidates, if approved, and may affect the prices we may obtain.
In the U.S. 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 regulatory 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 regulatory approval.
For example, in 2010, President Obama signed into law the PPACA, which contains provisions, among others, that may impact our potential product candidates, including:
| an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents; |
| an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program; |
| expansion of healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, new government investigative powers and enhanced penalties for noncompliance; |
| a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices; |
| extension of manufacturers Medicaid rebate liability; |
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| expansion of eligibility criteria for Medicaid programs; |
| new requirements to report financial arrangements with physicians and teaching hospitals; |
| a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; |
| a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; |
| the Independent Payment Advisory Board, which, if created, would have authority to recommend certain changes to the Medicare program that could result in reduced payments for prescription drugs; and |
| a Center for Medicare Innovation at the Centers for Medicare & Medicaid Services (CMS) to test innovative payment and service delivery models to lower Medicare and Medicaid spending. |
Other legislative changes have been proposed and adopted since the PPACA was enacted. These changes included aggregate reductions of Medicare payments to providers of up to two percent per fiscal year. Additionally, in January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several providers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. Further, while the healthcare reform agenda and policies of the new Trump administration are not fully known, it is possible that additional regulatory changes, as well as the repeal (in whole or in part) of the PPACA, could negatively affect insurance coverage and/or drug prices. These new laws also may result in additional reductions in Medicare and other healthcare funding as well as insurance coverage and payments.
We expect that the PPACA, as well as other healthcare reform measures that may be adopted in the future, may result in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria, new payment methodologies and additional downward pressure on the reimbursement received 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.
Moreover, there recently has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed bills designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. Individual states in the U.S. have also become increasingly active in implementing regulations designed to control pharmaceutical 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, encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, results of operations, financial condition and prospects.
Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. Additionally, legislation has been introduced to repeal the PPACA. We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the regulatory approvals of our product candidates, if any, may be. In addition, increased scrutiny by the U.S. Congress of the FDAs approval process may significantly delay or prevent regulatory approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.
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Governments outside the U.S. tend to impose strict price controls, which may adversely affect our revenues, if any.
In some countries, particularly certain countries of the European Union (EU), 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 regulatory approval for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical study that compares the cost-effectiveness of our product candidate to other available therapies. If reimbursement of 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.
Risks Relating to Our Reliance on Third Parties
We rely on third parties to conduct our preclinical and clinical studies. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.
We have agreements with third-party contract research organizations (CROs) to monitor and manage data for our preclinical and clinical programs. We rely heavily on these third parties for execution of our preclinical and clinical studies and control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on CROs does not relieve us of our regulatory responsibilities. We and our CROs are required to comply with cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for products in clinical development. Regulatory authorities enforce these cGCPs through periodic inspections of study sponsors, principal investigators and study sites. If we, the investigators, the sites or any of these CROs fail to comply with applicable cGCPs, the clinical data generated in our clinical studies may be deemed unreliable and the regulatory authorities may require us to perform additional clinical studies before approving our marketing applications. We cannot assure you that, upon inspection, such regulatory authorities will determine that any of our clinical studies comply with the cGCP regulations. In addition, our clinical studies must be conducted with product produced under cGMP regulations. Failure to comply with these regulations may require us to repeat clinical studies, which would delay or compromise the regulatory approval process.
If our relationships with any of these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs or to do so on commercially reasonable terms. In addition, our CROs are not our employees, and except for remedies available to us under our agreements with such CROs, we cannot control whether or not they devote sufficient time and resources to our ongoing preclinical and clinical programs. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical studies may be extended, delayed or terminated. As a result, we may not be able to obtain regulatory approval for, or successfully commercialize, our product candidates and may incur significant additional expenses. In addition, potential approval of our product candidates may be delayed, which would have a material adverse effect on our business, results of operations and financial condition.
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If the third-party manufacturers on which we rely fail to produce our product candidates on a timely basis, or comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the studies, regulatory submissions, required approvals or commercialization of our product candidates.
We contract with third-party contract development and manufacturing organizations (CDMOs) to manufacture our product candidate, and we would expect to rely on these CDMOs to produce commercial quantities of tesetaxel. The manufacture of pharmaceutical products requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of pharmaceutical products often encounter difficulties in production, which include difficulties with production costs and yields, quality control and assurance and shortages of qualified personnel, as well as compliance with strictly enforced governmental regulations, including cGMPs. The CDMOs we contract with may not perform as agreed or may terminate their agreements with us.
In addition to product approval, any facilities in which our product candidates are manufactured or tested for their ability to meet required specifications must be inspected and approved by regulatory authorities before a commercial product can be manufactured. Failure of such a facility to be approved could delay the approval of one or more of our product candidates.
Any of these factors could cause us to delay or suspend any future clinical studies, regulatory submissions, required approvals or commercialization of one or more of our product candidates, entail higher costs and result in our being unable to effectively commercialize products.
Risks Relating to Intellectual Property
Our success in developing and marketing our product candidates depends significantly on our ability to obtain and maintain patent protection and operate without infringing on the rights of others.
We depend on patents and other intellectual property to prevent others from improperly benefiting from products or inventions that we developed or acquired. Our patents and patent applications cover our product candidates and inventions. The intellectual property portfolio protecting our tesetaxel program includes 9 U.S., 4 European and 7 Japanese patents, as well as two pending U.S. patent applications and one pending European patent application. Of those, 5 U.S., 4 European and 6 Japanese patents are exclusively licensed to us by Daiichi Sankyo. Among the licensed patents, one issued U.S. patent (U.S. Patent No. 7,410,980) covers the crystal form of tesetaxel used in our clinical formulation and will expire in 2026. If tesetaxel is approved by the FDA, we will be entitled to request patent term restoration that could extend the protection of this patent until 2031. The exact duration of the extension depends on the time we spend in clinical studies as well as the time the FDA spends reviewing our NDA. See BusinessGovernment Regulation and Product ApprovalU.S. Patent Term Restoration and Marketing Exclusivity. The licensed portfolio includes 4 other issued U.S. patents that cover compositions of matter and various methods useful for preparing tesetaxel, as well as European and Japanese counterparts of these U.S. patents. We also own 4 U.S. patents that cover additional methods useful for preparing tesetaxel and certain salt and crystal forms of tesetaxel, as well as two pending U.S. patent applications related to tesetaxel. For one of those U.S. patent applications, if it results in an issued patent, that patent would expire in 2038.
The patent position of pharmaceutical firms like ours is highly uncertain and involves complex legal and factual questions. We intend to continue to file patent applications because we believe it is appropriate to obtain patents covering our products and their manufacture and use. There can be no assurance, however, that any additional patents will issue, that the scope of any patent that has issued or may issue will be sufficient to protect our product candidates, or that any current or future issued patent will be held not invalid if subsequently challenged. Additionally, we may have to incur significant
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expense and expend management time defending or enforcing our patents. If we cannot obtain and maintain effective patent rights and/or regulatory exclusivity for our product candidates, we may not be able to compete effectively, and our business and results of operations would be harmed.
The scope and terms of our patents may be insufficient to protect our product candidates for an adequate amount of time.
In the U.S., the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such product candidates might expire before or shortly after such product candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing product candidates similar or identical to ours.
Patents may be eligible for limited patent term extension in the U.S. under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Act. Similar patent extensions exist in the EU and Japan. The Hatch-Waxman Act permit a patent term extension of up to 5 years for a patent covering an approved product as compensation for patent term that elapsed during product development and the FDA regulatory review process, provided the extension does not extend the total patent term beyond 14 years from approval, and only one patent per approved product is extended. We may not receive an extension if we fail to apply within applicable deadlines or fail to apply prior to expiration of relevant patents. Moreover, the length of the extension could be less than we request. If we are unable to obtain patent term extension or the term of any such extension is less than we request, the period during which we can enforce our patent rights for that product will be shortened and our competitors may obtain approval to market competing products sooner, impacting our revenue.
If the FDA or foreign regulatory authorities approve generic versions of any of our products that receive marketing approval or such authorities do not grant our products appropriate periods of exclusivity before approving generic versions of our products, the sales of our products could be adversely affected.
NDA applicants are required to list with the FDA each patent with claims covering the applicants product or method of using the product for which approval is sought. Upon approval of a drug, each of the patents listed in the application for the drug that cover the drug or an approved use of the drug is then published in the FDAs Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Drugs listed in the Orange Book can, in turn, be cited by potential generic or 505(b)(2) NDA applicants in support of approval of an Abbreviated New Drug Application (ANDA) or a 505(b)(2) NDA. An ANDA is a streamlined way to seek approval for marketing a drug product that has the same active ingredient in the same strength and dosage form as the listed drug and has been shown to be bioequivalent to the listed drug. Other than the requirement for bioequivalence testing, ANDA applicants are not required to conduct or submit results of preclinical or clinical tests to prove the safety or effectiveness of their drug product. Drugs approved in this way can often be substituted by pharmacists under prescriptions written for the original listed drug.
Both ANDA and 505(b)(2) NDA applicants are required to make a certification to the FDA concerning any patents listed for the approved NDA product in the FDAs Orange Book. Specifically, ANDA and 505(b)(2) NDA applicants must certify that: (i) the required patent information has not been filed; (ii) the listed patent has expired; (iii) the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or (iv) the listed patent is invalid or will not be infringed by the new product. The ANDA applicant may also elect to submit a statement
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certifying that its proposed ANDA labeling does not contain (or carves out) any language regarding patented methods-of-use rather than certify to a listed method-of-use patent. If the applicant does not challenge the listed patents, the submitted application will not be approved until all the listed patents claiming the referenced product have expired.
A certification that the proposed product will not infringe the already approved products listed patents, or that such patents are invalid or unenforceable, is called a Paragraph IV certification. If the applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA and patent holders once the ANDA or 505(b)(2) NDA has been received by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the Paragraph IV certification. The filing of a patent infringement lawsuit within 45 days of the receipt of a Paragraph IV certification automatically prevents the FDA from approving a submitted application until the earlier of 30 months, expiration of the patent, settlement of the lawsuit or a decision in the infringement case that is favorable to the ANDA applicant or 505(b)(2) applicant.
In addition to the protections from competitors that may be afforded by patents, pharmaceutical products may also be eligible for regulatory exclusivity, such as the exclusivity that may be granted to New Chemical Entities (NCEs). While we believe that tesetaxel will qualify as an NCE if and when an NDA is submitted for tesetaxel, such determination is only made at the time of approval. Accordingly, we do not have any agreement with the FDA, EMA or other regulatory body that tesetaxel will in fact be regarded as an NCE, and there can be no assurance that it will be treated as such at the time of approval (if approval is granted).
Competition that our products may face from generic versions of our products could materially and adversely impact our future revenue, profitability and cash flows and substantially limit our ability to obtain a return on the investments we have made in those product candidates.
If we fail to comply with our obligations under our licenses, we may lose rights to critical patents that are important to the commercialization and revenue potential of tesetaxel.
We have licensed patent rights covering tesetaxel from Daiichi Sankyo. If, for any reason, our license agreement with Daiichi Sankyo is terminated or we otherwise lose those rights, it could adversely affect our business. Our license agreement with Daiichi Sankyo imposes, and any future collaboration agreements or license agreements we enter into are likely to impose, various development, commercialization, funding, milestone, royalty, diligence, sublicensing, insurance, patent prosecution and enforcement or other obligations on us. Failure to fulfill these obligations could pose a material risk to our patent protection for tesetaxel and any future product candidates.
If our product candidates infringe the rights of others, we could be subject to expensive litigation, become liable for substantial damages, be required to obtain licenses from others or be prohibited from selling our product candidates altogether.
Our competitors or others may have patent rights that they choose to assert against us or our licensors, licensees, suppliers, customers or potential marketing partners. Moreover, we may not know about patents or patent applications that our products would infringe. Because patent applications do not publish for at least 18 months, if at all, and can take many years to issue, there may be currently pending applications unknown to us that may later result in issued patents that our product candidates would infringe. In addition, if third parties file patent applications or obtain patents claiming inventions also claimed by us or our licensors in issued patents or pending applications, we may have to participate in interference proceedings in the U.S. Patent and Trademark Office (USPTO) to determine priority of invention. If third parties file oppositions in foreign countries, we may also have to participate in opposition proceedings in foreign tribunals to defend the patentability of our foreign patent applications.
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If a third party claims that we infringe its proprietary rights, any of the following may occur:
| we may become involved in time-consuming and expensive litigation, even if the claim is without merit; |
| we may become liable for substantial damages for past infringement if a court decides that our science infringes a competitors patent; |
| a court may prohibit us from selling or licensing our product without a license from the patent holder, which may not be available on commercially acceptable terms, if at all, or which may require us to pay substantial royalties or grant cross licenses to our patents; or |
| we may have to redesign our product candidates so that they do not infringe patent rights of others, which may not be possible or commercially feasible. |
Any of these events would have a material adverse effect on our business, results of operations and financial condition.
Patent policy and rule changes could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
Changes in either the patent laws or interpretation of the patent laws in the U.S. and other countries may diminish the value of our patents or narrow the scope of our patent protection. The laws of foreign countries may not protect our rights to the same extent as the laws of the U.S. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the U.S. and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. We therefore cannot be certain that we or our licensors were the first to make the inventions claimed in our owned and licensed patents or pending applications, or that we or our licensor were the first to file for patent protection of such inventions.
Assuming the other requirements for patentability are met, in the U.S., prior to March 15, 2013, the first to make the claimed invention is entitled to the patent, while, outside the U.S., the first to file a patent application is entitled to the patent. After March 15, 2013, under the Leahy-Smith America Invents Act (Leahy-Smith Act), enacted on September 16, 2011, the U.S. has moved to a first-to-file system. The Leahy-Smith Act also includes a number of significant changes that affect the way patent applications will be prosecuted and may also affect patent litigation. In general, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, results of operations and financial condition.
Among some of the other changes introduced by the Leahy-Smith Act are changes that limit where a patentee may file a patent infringement suit and provide new opportunities for third parties to challenge issued patents in the USPTO. We may be subject to the risk of third-party prior art submissions on pending applications or become a party to opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our patents for tesetaxel. There is a lower standard of evidence necessary to invalidate a patent claim in a USPTO proceeding relative to the standard in U.S. district or federal court. This could lead third parties to challenge and successfully invalidate our patents that would not otherwise be invalidated if challenged through the court system.
In addition to patent protection, we will need to successfully preserve our trade secrets. If we are unable to maintain effective proprietary rights for tesetaxel or any future product candidates, we may not be able to compete effectively in our markets.
In addition to the protection afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable or that we elect not to patent, processes for which patents are difficult to enforce and any other elements of our product
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candidate discovery and development processes that involve information or know-how that is not covered by patents. However, trade secrets can be difficult to protect. We seek to protect our proprietary science and processes, in part, by entering into confidentiality agreements with our employees, consultants, scientific advisors and contractors. We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems. While we have confidence in these individuals, organizations and systems, there remains the possibility that agreements or security measures may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors. For instance, the FDA has introduced its Transparency Initiative and is currently considering whether to publicly disclose additional information from drug sponsors; in such case, we cannot guarantee that our trade secrets will not be disclosed.
Although we expect all of our employees and consultants to assign their inventions to us, and all of our employees, consultants, advisors and any third parties who have access to our proprietary know-how, science or information to enter into confidentiality agreements, we cannot provide any assurances that all such agreements have been duly executed, that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Misappropriation or unauthorized disclosure of our trade secrets could impair our competitive position and may have a material adverse effect on our business. Additionally, if the steps taken to maintain our trade secrets are deemed inadequate, we may have insufficient recourse against third parties for misappropriating our trade secrets.
Risks Related to this Offering and Ownership of Our Common Stock
There is no existing market for our common stock and we do not know if one will develop. Even if a market does develop, the stock prices in the market may not exceed the offering price.
Prior to this offering, there has not been a public market for our common stock or any of our equity interests. We cannot predict the extent to which investor interest in our company will lead to the development of an active trading market on NASDAQ, or how liquid that market may become. An active public market for our common stock may not develop or be sustained after this offering. If an active trading market does not develop or is not sustained, you may have difficulty selling any shares of our common stock that you buy. An inactive market may also impair our ability to raise additional capital.
The initial public offering price for the common stock will be determined by negotiations among us and the representatives of the underwriters and may not be indicative of prices that will prevail in the open market following this offering. Consequently, you may not be able to sell shares of our common stock at prices equal to or greater than the price you pay in this offering.
The price of our common stock may be volatile, and you may lose all or part of your investment.
The market price of our common stock could fluctuate significantly, and you may not be able to resell your shares at or above the offering price. Those fluctuations could be based on various factors in addition to those otherwise described in this prospectus, including those described under Risk FactorsRisks Related to Our Business, Risk FactorsRisks Related to Our Industry, Risk FactorsRisks Related to Our Reliance on Third Parties and Risk FactorsRisks Related to Intellectual Property, and the following:
| unfavorable developments relating to the regulatory status of our product candidates, such as the FDA refusing to accept for filing our NDA or issuing a complete response letter, or a delay in the regulatory review process; |
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| adverse actions taken by regulatory authorities with respect to our clinical studies, manufacturing supply chain or future sales and marketing activities; |
| unfavorable results from our clinical studies; |
| delays in the initiation or completion of our clinical studies; |
| adverse changes to our relationships with third-party service providers; |
| manufacture, supply or distribution shortages; |
| departures of our management; |
| a change in competitive landscape that is unfavorable to our product candidates; |
| actual or threatened intellectual property litigation that involves our product candidates; |
| adverse developments concerning the pharmaceutical industry in general; |
| higher-than-expected expenses related to our development programs or overall corporate operations; |
| financial results that are not in line with analyst expectations; |
| changes in analyst estimates, ratings and price targets; |
| press reports or other negative publicity, whether or not true, about our business; |
| release or expiry of lock-up or other transfer restrictions on our outstanding common stock; |
| sales or perceived potential sales of additional common stock; |
| sales of our common stock by us, our executive officers and directors or our stockholders in the future; |
| fluctuations in the stock prices of pharmaceutical and biotechnology stocks; and |
| general economic and market conditions and overall fluctuations in the U.S. equity markets. |
Any of these factors may result in large and sudden changes in the volume and trading price of our common stock. In the past, following periods of volatility in the market price of a companys securities, stockholders have often instituted securities class action litigation against that company. If we were involved in a class action suit, it could divert the attention of management, result in negative press reports and, if adversely determined, have a material adverse effect on our results of operations and financial condition.
In addition, the stock market, in general, and the stocks of small pharmaceutical and 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. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance. Further, a decline in the financial markets and related factors beyond our control may cause our common stock price to decline rapidly and unexpectedly.
Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
Upon completion of this offering, we will become subject to the periodic reporting requirements of the Securities Exchange Act of 1934, as amended (Exchange Act). Our disclosure controls and procedures are designed to reasonably assure that information required to be disclosed by us in reports we file or submit under the Exchange Act is accumulated and communicated to management and recorded, processed, summarized and reported within the time periods specified in the rules and forms of the U.S. Securities and Exchange Commission (SEC).
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Disclosure controls and procedures or internal controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.
These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected.
Future sales of our common stock, or the perception that such sales may occur, could depress our common stock price.
Sales of a substantial number of shares of our common stock in the public market, or the perception that such sales may occur, following this offering could depress the market price of our common stock. Our principal stockholders, executive officers and directors and certain other equity holders have agreed with the underwriters not to offer, sell, dispose of or hedge any shares of common stock or securities convertible into or exchangeable for shares of common stock, subject to specified limited exceptions and extensions described elsewhere in this prospectus, during the period ending 180 days (subject to extension) after the date of the final prospectus, except with the prior written consent of Goldman Sachs & Co. LLC and Jefferies LLC. Our certificate of incorporation will authorize us to issue up to 100,000,000 shares of common stock, of which 26,520,356 shares will be outstanding immediately after this offering. All of our outstanding shares will be freely tradable after the expiration date of the lock-up agreements, except for any shares held or acquired by persons who may be deemed to be our affiliates. Shares of our common stock held by our affiliates will continue to be subject to the volume and other restrictions of Rule 144 under the U.S. Securities Act of 1933 (Securities Act). Goldman Sachs & Co. LLC and Jefferies LLC may, in their sole discretion and at any time without notice, release all or any portion of the shares subject to the lock-up. Sales of a substantial number of such shares upon expiration of the lock-up and market stand-off agreements, the perception that such sales may occur or early release of these agreements could cause our market price to fall or make it more difficult for you to sell your common stock at a time and price that you deem appropriate. See Underwriting.
In addition, immediately following this offering, we intend to file a registration statement registering under the Securities Act the shares of common stock reserved for issuance under our 2017 Stock Option Plan and our 2017 Employee Stock Purchase Plan. See Shares Eligible for Future Sale for a more detailed description of the shares that will be available for future sales upon completion of this offering.
We have broad discretion as to the use of proceeds from this offering and may not use the proceeds effectively.
Our management will retain broad discretion as to the allocation of the proceeds and may spend these proceeds in ways in which you may not agree. The failure of our management to apply these funds effectively could result in unfavorable returns and uncertainty about our prospects, each of which could cause the price of our common stock to decline.
Because we do not expect to pay dividends in the foreseeable future, you must rely on price appreciation of our common stock for return on your investment.
We intend to retain most, if not all, of our available funds and earnings to fund the development and growth of our business. As a result, we do not expect to pay any cash dividends in the foreseeable future. Therefore, you should not rely on an investment in our common stock as a source for any future dividend income.
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Our Board has significant discretion as to whether to distribute dividends and in what amounts. Even if our Board decides to declare and pay dividends, the timing, amount and form of future dividends, if any, will depend on, among other things, our future results of operations and cash flow, our capital requirements and surplus, the amount of distributions, if any, received by us from our subsidiaries, our financial condition, contractual restrictions and other factors deemed relevant by our Board.
If you purchase shares of our common stock sold in this offering, you will incur immediate and substantial dilution.
If you purchase shares of our common stock in this offering, you will incur immediate and substantial dilution in the amount of $17.40 per share because the assumed public offering price of $25.50 per share, the midpoint of the range set forth on the cover of this prospectus, is substantially higher than the as-adjusted net tangible book value per share of our outstanding common stock. This dilution is due in large part to the fact that our earlier investors paid substantially less than the initial public offering price when they purchased their shares. In addition, you may also experience additional dilution upon future equity issuances or the issuance of stock options to purchase common stock granted to our employees and directors under our stock option and stock purchase plans after this offering. To the extent we raise additional capital by issuing equity securities our stockholders will experience substantial additional dilution. See Dilution.
Our directors, executive officers and principal stockholders will continue to have substantial control over the Company after this offering, which could limit your ability to influence the outcome of key transactions, including a change of control.
Without giving effect to any shares they may purchase in this offering, our current directors, officers and unitholders who own greater than 5% of our outstanding common units, together with their affiliates, will beneficially own, in the aggregate, approximately 63% of our outstanding common stock after this offering, based on the number of units outstanding as of November 27, 2017. As a result, after this offering, these current directors, officers and stockholders, if they act, will be able to influence or control matters requiring approval by our stockholders, including the election of directors and the approval of mergers, acquisitions or other extraordinary transactions. In addition, our current directors, officers and unitholders, acting together, would have the ability to control the management and affairs of our company. They may also have interests that differ from yours and may vote in a way with which you disagree and that may be adverse to your interests. This concentration of ownership may have the effect of delaying, preventing or deterring a change of control of our company, could deprive our stockholders of an opportunity to receive a premium for their common stock as part of a sale of our company and could affect the market price of our common stock.
We are an emerging growth company, as defined in the Securities Act, and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our common stock less attractive to investors.
We are an emerging growth company, as defined in Section 2(a) of the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012 (JOBS Act), and we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including relief from the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended, less extensive disclosure obligations regarding executive compensation in our registration statements, periodic reports and proxy statements, exemptions from the requirements to hold a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved and an extended transition period for complying with new or revised accounting
31
standards. As a result, our stockholders may not have access to certain information that they may deem important. We could be an emerging growth company for up to 5 years, although circumstances could cause us to lose that status earlier, including if our total annual gross revenues exceed $1.07 billion, if we issue more than $1.0 billion in non-convertible debt during any three-year period, or if the market value of our common stock held by non-affiliates exceeds $700 million as of June 30 of any year.
In addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. An emerging growth company can therefore delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. However, we are choosing to opt out of such extended transition period, and, as a result, we will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-emerging growth companies. Section 107 of the JOBS Act provides that our decision to opt out of the extended transition period for complying with new or revised accounting standards is irrevocable.
We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.
32
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements within the meaning of the federal securities laws, which statements involve substantial risks and uncertainties. All statements, other than statements of historical facts included in this prospectus, including statements concerning our plans, objectives, goals, strategies, future events, future revenues or performance, financing needs, plans or intentions relating to acquisitions, business trends and other information referred to under Prospectus Summary, Risk Factors, Managements Discussion and Analysis of Financial Condition and Results of Operations and Business are forward-looking statements. Forward-looking statements generally relate to future events or our future financial or operating performance. In some cases, you can identify forward-looking statements by terms such as may, might, will, objective, intend, should, could, can, would, expect, believe, design, estimate, predict, potential, plan or the negative of these terms, and similar expressions intended to identify forward-looking statements. Forward-looking statements are not historical facts, and reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
There are a number of risks, uncertainties and other important factors that could cause our actual results to differ materially from the forward-looking statements contained in this prospectus. Such risks, uncertainties and other important factors include, among others, the risks, uncertainties and factors set forth above under Risk Factors, and the following risks, uncertainties and factors:
| our plans to develop and commercialize tesetaxel and any other product candidates; |
| our ongoing and planned clinical studies; |
| the timing of and our ability to obtain regulatory approvals for tesetaxel and any other product candidates; |
| our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; |
| our ability to identify additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; |
| the rate and degree of market acceptance and clinical utility of tesetaxel and any other product candidates, if approved; |
| our commercialization, marketing and manufacturing capabilities and strategy; |
| significant competition in our industry; |
| our intellectual property position; |
| loss or retirement of key members of management; |
| failure to successfully execute our growth strategy, including any delays in our planned future growth; and |
| our failure to maintain effective internal controls. |
There may be other factors that may cause our actual results to differ materially from the forward-looking statements, including factors disclosed in Risk Factors and Managements Discussion and Analysis of Financial Condition and Results of Operations. You should evaluate all forward-looking statements made in this prospectus in the context of these risks and uncertainties.
We caution you that the risks, uncertainties and other factors referred to above may not contain all of the risks, uncertainties and other factors that are important to you. In addition, we cannot assure
33
you that we will realize the results, benefits or developments that we expect or anticipate or, even if substantially realized, that they will result in the consequences or affect us or our business in the way expected. All forward-looking statements in this prospectus apply only as of the date made and are expressly qualified in their entirety by the cautionary statements included in this prospectus. We undertake no obligation to publicly update or revise any forward-looking statements to reflect subsequent events or circumstances.
34
We obtained the industry, market and competitive position data used throughout this prospectus from our own internal estimates and research, as well as from industry and general publications, in addition to research, surveys and studies conducted by third parties. Internal estimates are derived from publicly available information released by industry analysts and third-party sources, our internal research and our industry experience, and are based on assumptions made by us based on such data and our knowledge of our industry and market, which we believe to be reasonable. In addition, while we believe the industry, market and competitive position data included in this prospectus is reliable and based on reasonable assumptions, such data involve risks and uncertainties and are subject to change based on various factors, including those discussed in Risk Factors. These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us.
35
We estimate that we will receive net proceeds of approximately $137.1 million (or approximately $158.0 million if the underwriters option to purchase additional shares is exercised in full) from the sale of the common shares offered by us in this offering, based on an assumed public offering price of $25.50 per share (the midpoint of the range set forth on the cover page of this prospectus), and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.
We intend to use the net proceeds of this offering as follows:
| Approximately $65 million to conduct our multinational, multicenter, randomized, Phase 3 study in patients with MBC, known as CONTESSA; |
| Approximately $20 million to conduct other clinical studies of tesetaxel; and |
| Approximately $20 million on manufacturing activities relating to tesetaxel. |
The remainder of the net proceeds will be used for working capital and general corporate purposes.
Our expected use of proceeds from this offering represents our current intentions based on our present plans and business condition. As of the date of this prospectus, we cannot predict with certainty all of the particular uses for the proceeds to be received upon the completion of this offering or the actual amounts that we will spend on the uses set forth above. We may also use a portion of the proceeds to in-license, acquire or invest in additional businesses, technologies, products or assets. Although we have no specific agreements, commitments or understandings with respect to any in-licensing activity or acquisition, we evaluate these opportunities and engage in related discussions with other companies from time to time.
The amount and timing of our actual expenditures will depend on numerous factors, including the results of our research and development efforts, the timing and outcome of any ongoing or future preclinical or clinical studies, and the timing and outcome of regulatory submissions. As a result, our management will have broad discretion over the use of the proceeds from this offering.
Pending the use of the proceeds from this offering, we may invest the proceeds in interest-bearing, investment-grade securities, certificates of deposit or government securities.
36
We have no present intention to pay cash dividends on our common stock. Any determination to pay dividends to holders of our common stock will be at the discretion of our Board and will depend on many factors, including our financial condition, results of operations, projections, liquidity, earnings, legal requirements, restrictions in the agreements governing any indebtedness we may enter into and other factors that our Board deems relevant.
37
The following table sets forth our cash and capitalization as of September 30, 2017 on:
| an actual basis; and |
| an as-adjusted basis to reflect the Conversion and $137.1 million in proceeds from the issuance and sale of 5,880,000 shares of our common stock in this offering, based on an assumed public offering price of $25.50 per share, the midpoint of the range set forth on the cover of this prospectus and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. |
You should read the following table in conjunction with Use of Proceeds, Selected Financial Data, Managements Discussion and Analysis of Financial Condition and Results of Operations and our financial statements and related notes included in this prospectus.
As of September 30, 2017 | ||||||||
Actual | As-adjusted (1) | |||||||
(unaudited) | ||||||||
(in thousands, except unit and per-unit/share amounts) |
||||||||
Cash |
$ | 74,504 | $ | 211,822 | ||||
|
|
|
|
|||||
Members/Stockholders equity: |
||||||||
Common units17,708,954 units issued and outstanding at September 30, 2017; no units issued and outstanding, as-adjusted |
$ | 91,739 | $ | - | ||||
Incentive units2,365,950 units issued and outstanding at September 30, 2017; no units issued and outstanding, as-adjusted |
- | - | ||||||
Common stock, $0.01 par value, no shares authorized, issued and outstanding; 100,000,000 shares authorized, 25,954,904 shares issued and outstanding, as-adjusted |
- | 260 | ||||||
Additional paid-in capital |
- | 233,570 | ||||||
Non-cash contributed capital |
4,991 | - | ||||||
Accumulated deficit |
(23,546 | ) | (23,546 | ) | ||||
|
|
|
|
|||||
Total members/stockholders equity |
73,184 | 210,284 | ||||||
|
|
|
|
|||||
Total capitalization |
$ | 73,184 | $ | 210,284 | ||||
|
|
|
|
(1) | As-adjusted to reflect the Conversion and $137.1 million in proceeds from the issuance and sale of 5,880,000 shares of our common stock in this offering, based on an assumed public offering price of $25.50 per share, the midpoint of the range set forth on the cover of this prospectus and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. |
The outstanding unit and share information in the table above excludes:
| 4,800,000 shares of common stock reserved for future grant or issuance under our 2017 Stock Option Plan, which will become effective prior to the completion of this offering; |
| 500,000 shares of common stock reserved for future issuance under our 2017 Employee Stock Purchase Plan, which will become effective prior to the completion of this offering; and |
| a net increase of 565,452 incentive units outstanding as a result of issuances and forfeitures from October 1, 2017 through November 27, 2017. |
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Dilution represents the difference between the amount per share paid by investors in this offering and the as-adjusted net tangible book value per share of our common stock immediately after this offering. The data in this section are derived from our balance sheet as of September 30, 2017 and are presented after giving effect to the Conversion. As-converted net tangible book value per share is equal to our total tangible assets less the amount of our total liabilities, divided by the sum of the number of our shares of common stock that will be outstanding immediately prior to the closing of this offering after giving effect to the Conversion. Our as-converted net tangible book value as of September 30, 2017, after giving effect to the Conversion, was $73.2 million, or $3.65 per share of common stock.
After giving effect to our receipt of the estimated net proceeds from our sale of common stock in this offering, based on an assumed public offering price of $25.50 per share, the midpoint of the range set forth on the cover page of this prospectus, after deducting the estimated underwriting discounts and commissions and other estimated offering expenses payable by us, our net tangible book value, as-adjusted, as of September 30, 2017 would have been $210.3 million, or $8.10 per share of common stock. This represents an immediate increase in net tangible book value to our existing stockholders of $4.45 per share and an immediate dilution to new investors in this offering of $17.40 per share. The following table illustrates this per share dilution:
Assumed public offering price per share |
$ | 25.50 | ||||||
As-converted net tangible book value per share as of September 30, 2017 |
$ | 3.65 | ||||||
Increase in net tangible book value per share attributable to new investors |
$ | 4.45 | ||||||
|
|
|||||||
As-adjusted net tangible book value per share after this offering |
$ | 8.10 | ||||||
|
|
|||||||
Dilution per share to new investors |
$ | 17.40 | ||||||
|
|
A $1.00 increase (decrease) in the assumed public offering price of $25.50 per share would increase (decrease) our as-adjusted net tangible book value by $5.5 million, the as-adjusted net tangible book value per share after this offering by $0.21 and the dilution per share to new investors by $0.79, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.
Each increase of 1,000,000 shares in the number of shares offered by us would increase our as-adjusted net tangible book value by $23.7 million, increase the as-adjusted net tangible book value per share after this offering by $0.58 and decrease the dilution per share to new investors by $0.58, assuming the assumed public offering price remains the same and after deducting the estimated underwriting discounts and commissions and estimated expenses payable by us. Each decrease of 1,000,000 shares in the number of shares offered by us would decrease our as-adjusted net tangible book value by $23.7 million, decrease the as-adjusted net tangible book value per share after this offering by $0.62 and increase the dilution per share to new investors by $0.62, assuming the assumed public offering price remains the same and after deducting the estimated underwriting discounts and commissions and estimated expenses payable by us.
If the underwriters fully exercise their option to purchase additional shares, as-adjusted net tangible book value after this offering would increase by approximately $0.52 per share, and there would be an immediate dilution of approximately $16.88 per share to new investors.
The following table presents, on an as-adjusted basis, as described above, the differences between the existing stockholders and the purchasers of shares in this offering with respect to the
39
number of shares purchased from us, the total consideration paid, and the average price paid per share at an assumed public offering price of $25.50 per share (the midpoint of the range set forth on the cover page of this prospectus):
Shares Purchased |
Total Consideration |
Average
Price Per Share |
||||||||||||||||||
Number | Percent | Amount | Percent | |||||||||||||||||
(in thousands) | ||||||||||||||||||||
Existing stockholders |
20,074,904 | 77 | % | $ | 90,009 | 38 | % | $ | 4.48 | |||||||||||
New investors |
5,880,000 | 23 | 149,940 | 62 | 25.50 | |||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Total |
25,954,904 | 100 | % | $ | 239,949 | 100 | % | $ | 9.24 | |||||||||||
|
|
|
|
|
|
|
|
The foregoing table excludes:
| 4,800,000 shares of common stock reserved for future grant or issuance under our 2017 Stock Option Plan, which will become effective prior to the completion of this offering; |
| 500,000 shares of common stock reserved for future issuance under our 2017 Employee Stock Purchase Plan, which will become effective prior to the completion of this offering; and |
| a net increase of 565,452 incentive units outstanding as a result of issuances and forfeitures from October 1, 2017 through November 27, 2017. |
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The following table summarizes the historical financial and operating data for the periods indicated. The historical statement of operations data for the years ended December 31, 2015 and 2016 and the balance sheet data as of December 31, 2015 and 2016 are for Odonate Therapeutics, LLC prior to the completion of the Conversion and are derived from our audited financial statements included elsewhere in this prospectus. The historical statement of operations data for the nine-month periods ended September 30, 2016 and 2017 and the balance sheet data as of September 30, 2017 are for Odonate Therapeutics, LLC prior to the completion of the Conversion and are derived from our unaudited financial statements included elsewhere in this prospectus. The unaudited financial statements are prepared on the same basis as our audited financial statements, and in the opinion of management, reflect all adjustments, including all normal and recurring adjustments that we consider necessary for a fair statement of the financial position and results of operations for such periods.
The historical results presented below are not necessarily indicative of the results to be expected for any future period. This information should be read in conjunction with Risk Factors, Capitalization, Managements Discussion and Analysis of Financial Condition and Results of Operations and our financial statements and the related notes included elsewhere in this prospectus. Our financial statements are prepared in accordance with generally accepted accounting principles in the U.S. (GAAP).
Year Ended
December 31, |
Nine Months Ended
September 30, |
|||||||||||||||
2015 | 2016 | 2016 | 2017 | |||||||||||||
(unaudited) | ||||||||||||||||
(in thousands, except per-unit data) | ||||||||||||||||
Statements of Operations Data: |
||||||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
$ | - | $ | 2,622 | $ | 856 | $ | 14,862 | ||||||||
General and administrative |
158 | 463 | 283 | 2,136 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating expenses |
158 | 3,085 | 1,139 | 16,998 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss attributable to common unitholders |
$ | (158 | ) | $ | (3,085 | ) | $ | (1,139 | ) | $ | (16,998 | ) | ||||
|
|
|
|
|
|
|
|
|||||||||
Net loss per unit attributable to common unitholders: |
||||||||||||||||
Basic and diluted |
$ | (0.17 | ) | (0.54 | ) | $ | (0.27 | ) | $ | (1.37 | ) | |||||
|
|
|
|
|
|
|
|
|||||||||
Weighted average units outstanding: |
||||||||||||||||
Basic and diluted |
923 | 5,762 | 4,290 | 12,427 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
As-converted net loss per share attributable to common stockholders (unaudited): (1) |
||||||||||||||||
Basic and diluted |
$ | (0.54 | ) | $ | (1.36 | ) | ||||||||||
|
|
|
|
|||||||||||||
As-converted weighted average shares outstanding (unaudited): (1) |
||||||||||||||||
Basic and diluted |
5,762 | 12,515 | ||||||||||||||
|
|
|
|
(1) | Reflects the completion of the Conversion, without giving effect to the issuance of shares from this offering. |
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December 31, | September 30, | |||||||||||
2015 | 2016 | 2017 | ||||||||||
(unaudited) | ||||||||||||
(in thousands) | ||||||||||||
Selected Balance Sheet Data: |
||||||||||||
Cash |
$ | 138 | $ | 2,599 | $ | 74,504 | ||||||
Working capital |
111 | 2,269 | 72,264 | |||||||||
Total assets |
140 | 2,881 | 76,515 | |||||||||
Total liabilities |
29 | 598 | 3,331 | |||||||||
Accumulated deficit |
(3,463 | ) | (6,548 | ) | (23,546 | ) | ||||||
Total members/stockholders equity |
111 | 2,283 | 73,184 |
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MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together with our audited and unaudited financial statements and the related notes and other financial information included elsewhere in this prospectus. Some of the information contained in this discussion and analysis or set forth elsewhere in this prospectus, including information with respect to our plans and strategy for our business, include forward-looking statements that involve risks and uncertainties. You should review Risk Factors for a discussion of important factors that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Overview
We are a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer. Our initial focus is on the development of tesetaxel, a novel chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several potential therapeutic advantages over currently available taxanes, including: oral administration with a low pill burden and a patient-friendly dosing regimen; a formulation that does not contain solubilizing agents that are known to cause hypersensitivity (allergic) reactions; and improved activity against chemotherapy-resistant tumors. Tesetaxel has been generally well tolerated in clinical studies and has demonstrated robust single-agent antitumor activity in two Phase 2 studies in patients with locally advanced or metastatic breast cancer (MBC). We expect to begin enrolling patients in our multinational, multicenter, randomized, Phase 3 study in MBC, known as CONTESSA, in the fourth quarter of 2017 and report top-line results from this study in 2020. Our goal for tesetaxel is to develop an effective chemotherapy choice for patients that provides quality-of-life advantages over current alternatives.
We have no products approved for marketing, and we have not generated any revenue from product sales or other arrangements. To date, we have primarily funded our operations through the sale of common units. We have incurred losses in each year since our inception. Our net losses were $0.2 million and $3.1 million for the years ended December 31, 2015 and 2016, respectively, and $1.1 million and $17.0 million for the nine months ended September 30, 2016 and 2017, respectively. As of December 31, 2016 and September 30, 2017, we had an accumulated deficit of $6.5 million and $23.5 million, respectively. Substantially all of our operating losses resulted from expenses incurred in connection with advancing tesetaxel through development activities and general and administrative costs associated with our operations.
We expect to continue to incur significant expenses and increasing operating losses for at least the next several years. Our net losses may fluctuate significantly from quarter to quarter and year to year. We expect our expenses will increase substantially in connection with our ongoing activities as we:
| conduct clinical studies of tesetaxel, our initial product candidate; |
| increase our research and development efforts; |
| manufacture clinical study materials; |
| hire additional personnel; |
| create additional infrastructure to support our product development, planned future commercialization efforts and our operations as a public company; |
43
| seek regulatory approval for tesetaxel and any other product candidates that successfully complete clinical studies; |
| maintain, expand and protect our intellectual property portfolio; |
| make milestone or other payments under any in-licensing agreement; and |
| experience any delays or encounter challenges with respect to any of the above. |
We do not expect to generate any revenues from product sales until we successfully complete development and obtain regulatory approval for tesetaxel, which we expect will take a number of years. If we obtain regulatory approval for tesetaxel, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, we will seek to fund our operations through public or private equity or debt financings or other sources. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and ability to develop our product candidates.
Components of Our Results of Operations
Research and Development Expenses
Research and development expenses consist primarily of costs associated with the development of our product candidates and include salaries, benefits, travel and other related cost, including equity-based compensation expenses, for personnel engaged in research and development functions; expenses incurred under agreements with contract research organizations (CROs), investigative sites and consultants that conduct our preclinical and clinical studies; manufacturing development and scale-up expenses and the cost of acquiring and manufacturing clinical study materials and commercial materials, including manufacturing registration and validation batches; payments to consultants engaged in the development of our product candidates, including equity-based compensation, travel and other expenses; costs related to compliance with quality and regulatory requirements; research and development facility-related expenses, which include direct and allocated expenses, and other related costs. Research and development expenses are charged to operations as incurred when these expenditures relate to our research and development efforts and have no alternative future uses. Payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received.
All of our research and development expenses to date have been incurred in connection with tesetaxel. We expect our research and development expenses to increase for the foreseeable future as we advance tesetaxel through clinical development, including conducting our planned Phase 3 study, CONTESSA. The process of conducting clinical studies necessary to obtain regulatory approval is costly and time consuming. We are unable to estimate with any certainty the costs we will incur in the continued development of tesetaxel. The degree of success, timelines and cost of development can differ materially from expectations. We may never succeed in achieving regulatory approval for our product candidates.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries, related benefits, travel, equity-based compensation expense and facility-related expenses for personnel in finance and administrative functions. General and administrative expenses also include facility expenses, professional fees for legal, patent, consulting, accounting and audit services and other related costs.
44
We anticipate that our general and administrative expenses will increase in the future as we build our infrastructure to support our continued research and development of tesetaxel. We also anticipate increased expenses related to accounting, legal and regulatory-related services associated with maintaining compliance with exchange listing and the Securities and Exchange Commission (SEC) requirements, director and officer insurance premiums and other costs associated with being a public company.
Results of Operations
The following table summarizes our results of operations for the years ended December 31, 2015 and 2016 and the nine months ended September 30, 2016 and 2017:
Year Ended
December 31, |
Nine Months Ended
September 30, |
|||||||||||||||
2015 | 2016 | 2016 | 2017 | |||||||||||||
(unaudited) | ||||||||||||||||
(in thousands) | ||||||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
$ | - | $ | 2,622 | $ | 856 | $ | 14,862 | ||||||||
General and administrative |
158 | 463 | 283 | 2,136 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating expenses |
$ | 158 | $ | 3,085 | $ | 1,139 | $ | 16,998 | ||||||||
|
|
|
|
|
|
|
|
Research and Development Expense
The following table summarizes our research and development expense for the years ended December 31, 2015 and 2016 and the nine months ended September 30, 2016 and 2017:
Year Ended
December 31, |
Nine Months Ended
September 30, |
|||||||||||||||
2015 | 2016 | 2016 | 2017 | |||||||||||||
(unaudited) | ||||||||||||||||
(in thousands) | ||||||||||||||||
Clinical development costs |
$ | - | $ | 1,223 | $ | 416 | $ | 8,252 | ||||||||
Personnel and related costs |
- | 1,295 | 385 | 4,410 | ||||||||||||
Equity-based compensation expense |
- | 51 | 24 | 2,066 | ||||||||||||
Other research and development costs |
- | 53 | 31 | 134 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total research and development expense |
$ | - | $ | 2,622 | $ | 856 | $ | 14,862 | ||||||||
|
|
|
|
|
|
|
|
Comparison of the Nine Months Ended September 30, 2016 and 2017
Research and development expense was $0.9 million and $14.9 million for the nine months ended September 30, 2016 and 2017, respectively. The increase of $14.0 million was due to increased activities in connection with our tesetaxel clinical development program, resulting in increased clinical development costs of $7.8 million, increased personnel and related costs of $4.0 million, increased equity-based compensation expense of $2.0 million and increased other research and development costs of $0.1 million.
Comparison of the Years Ended December 31, 2015 and 2016
Research and development expense was $0 and $2.6 million for the years ended December 31, 2015 and 2016, respectively. The increase of $2.6 million was due to increased activities in connection
45
with our tesetaxel clinical development program, resulting in increased clinical development costs of $1.2 million, increased personnel and related costs of $1.3 million, increased equity-based compensation expense of $0.1 million and increased other research and development costs of $0.1 million.
General and Administrative Expense
The following table summarizes our general and administrative expense for the years ended December 31, 2015 and 2016 and the nine months ended September 30, 2016 and 2017:
Year Ended
December 31, |
Nine Months Ended
September 30, |
|||||||||||||||
2015 | 2016 | 2016 | 2017 | |||||||||||||
(unaudited) | ||||||||||||||||
(in thousands) | ||||||||||||||||
Personnel and related costs |
$ | - | $ | 158 | $ | 58 | $ | 1,055 | ||||||||
Equity-based compensation expense |
- | - | - | 132 | ||||||||||||
Other general and administrative costs |
158 | 305 | 225 | 949 | ||||||||||||
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Total general and administration expense |
$ | 158 | $ | 463 | $ | 283 | $ | 2,136 | ||||||||
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Comparison of the Nine Months Ended September 30, 2016 and 2017
General and administrative expense was $0.3 million and $2.1 million for the nine months ended September 30, 2016 and 2017, respectively. The increase of $1.8 million was due to increased administrative support costs resulting from the increased activities in connection with our tesetaxel clinical development program, resulting in increased personnel and related costs of $1.0 million, increased equity-based compensation expense of $0.1 million and increased other general and administrative expenses of $0.7 million.
Comparison of the Years Ended December 31, 2015 and 2016
General and administrative expense was $0.2 million and $0.5 million for the years ended December 31, 2015 and 2016, respectively. The increase of $0.3 million was due to increased administrative support costs resulting from the increased activities in connection with our tesetaxel clinical development program, resulting in increased personnel and related costs of $0.2 million and increased other general and administrative expenses of $0.1 million.
Liquidity and Capital Resources
We have incurred losses and negative cash flows from operations since inception and anticipate that we will continue to incur net losses for the foreseeable future. As of September 30, 2017, we had an accumulated deficit of $23.5 million. As of September 30, 2017, we had cash in the amount of $74.5 million.
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The following table sets forth a summary of the net cash flow activity for each of the periods set forth below:
Year Ended
December 31, |
Nine Months Ended
September 30, |
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2015 | 2016 | 2016 | 2017 | |||||||||||||
(unaudited) | ||||||||||||||||
(in thousands) | ||||||||||||||||
Net cash provided by (used in): |
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Operating activities |
$ | (165 | ) | $ | (1,733 | ) | $ | (752 | ) | $ | (11,783 | ) | ||||
Investing activities |
- | - | - | (68 | ) | |||||||||||
Financing activities |
- | 4,194 | 4,985 | 83,756 | ||||||||||||
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Net increase (decrease) in cash |
$ | (165 | ) | $ | 2,461 | $ | 4,233 | $ | 71,905 | |||||||
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Net cash used in operating activities was $0.2 million and $1.7 million for the years ended December 31, 2015 and 2016, respectively, and $0.8 million and $11.8 million for the nine months ended September 30, 2016 and 2017, respectively. The net cash used in operating activities in each of these periods was primarily due to our net losses and changes in working capital, which were partially offset by non-cash contribution of services by an affiliate of a significant unitholder, equity-based compensation and depreciation expense.
Net cash used in investing activities was the result of purchases of equipment.
Net cash provided by financing activities was $0 and $4.2 million for the years ended December 31, 2015 and 2016, respectively, and $5.0 million and $83.8 million for the nine months ended September 30, 2016 and 2017, respectively. Net cash provided by financing activities during each period was primarily the result of our sale of common units, net of capital distributions. For the year ended December 31, 2016, we distributed $0.8 million to our common unitholders.
We estimate that our net proceeds from this offering will be approximately $137.1 million, based on an assumed public offering price of $25.50 per share (the midpoint of the range set forth on the cover page of this prospectus), after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. We believe that our existing cash as of September 30, 2017 and the estimated net proceeds from this offering will be sufficient to meet our anticipated cash requirements through at least the next 24 months. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially.
Our future capital requirements are difficult to forecast and will depend on many factors, including:
| our ability to initiate, and the progress and results of, our planned clinical studies of tesetaxel; |
| the timing and outcome of regulatory reviews of tesetaxel; |
| the revenue, if any, received from commercial sales of tesetaxel for which we may receive regulatory approval; |
| our ability to maintain and enforce our intellectual property rights and defend any intellectual property-related claims; |
| the costs, timing and success of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive regulatory approval and do not partner for commercialization; and |
| the extent to which we acquire or in-license other products and technologies. |
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Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic partnerships and licensing arrangements. 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 or could 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 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, we may have to relinquish valuable rights to our product candidates, associated intellectual property, 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 through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidate even if we would otherwise prefer to develop and market such product candidate ourselves.
Contractual Obligations and Commitments
We enter into contracts in the normal course of business with CROs, contract development and manufacturing organizations and other service providers and vendors. These contracts generally provide for termination on notice and, therefore, are cancelable contracts and not included in the table of contractual obligations and commitments.
In 2013, we licensed rights to tesetaxel in all major markets from Daiichi Sankyo Company, Limited (Daiichi Sankyo), the original inventor of the product. Under the Daiichi Sankyo license agreement, we are obligated to use commercially reasonable efforts to develop and commercialize tesetaxel in the following countries: France, Germany, Italy, Spain, the United Kingdom and the U.S. We are required to make aggregate future milestone payments of up to $31.0 million, contingent on attainment of certain regulatory milestones. Additionally, we will pay Daiichi Sankyo a tiered royalty that ranges from the low to high single digits, depending on annual net sales of tesetaxel.
A summary of our contractual obligations and commitments as of December 31, 2016 is set forth below (in thousands):
Payments Due by Period | ||||||||||||||||
Less than
1 Year |
1 to 3
Years |
3 to 5
Years |
More than
5 Years |
Total
Amounts Committed |
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Milestone payments (1) |
- | - | - | - | $ | 31,000 | ||||||||||
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(1) | Represents potential aggregate future milestone payment amounts to Daiichi Sankyo. The actual amount and timing of these payments are uncertain, as the payments are contingent upon future events. |
Off-Balance Sheet Arrangements
During the periods presented, we did not have, nor do we currently have, any off-balance sheet arrangements as defined under the rules of the SEC.
Quantitative and Qualitative Disclosures about Market Risk
Interest Rate Risk
We do not currently have any cash equivalents or investments, but we do maintain significant amounts of cash at one or more financial institutions that are in excess of federally insured limits.
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Effects of Inflation
Inflation generally affects us by increasing our cost of labor and clinical study costs. We do not believe that inflation has had a material effect on our results of operations during the periods presented.
Jumpstart Our Business Startups Act
We are an emerging growth company, as defined in the JOBS Act. Under this act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and, therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. We also intend to rely on other exemptions provided by the JOBS Act, including without limitation, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002, as amended.
Critical Accounting Policies and Significant Judgments and Estimates
Our managements discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the U.S. (GAAP). The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses during the reporting periods. These items are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ materially from these estimates under different assumptions or conditions.
While our significant accounting policies are more fully described in the notes to our audited financial statements elsewhere in this prospectus, we believe that the following accounting policies related to accrued expenses and equity-based compensation are most critical to understanding and evaluating our reported financial results.
Accrued Expense s
As part of the process of preparing our financial statements, we are required to estimate our accrued expenses. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. The majority of our service providers invoice us monthly in arrears for services performed or when contractual milestones are met. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. We periodically confirm the accuracy of our estimates with the service providers and make adjustments if necessary. Examples of estimated accrued research and development expenses include costs associated with conducting our development and regulatory activities, including fees paid to third-party professional consultants and service providers, and costs to develop and manufacture clinical study materials.
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We base our accrued expenses on our estimates of the services received and efforts expended pursuant to our contractual arrangements. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our service providers will exceed the level of services provided and result in a prepayment of the expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or prepayment accordingly.
Although we do not expect our estimates to be materially different from amounts actually incurred, if our estimates of the status and timing of services performed differs from the actual status and timing of services performed, we may report amounts that are too high or too low in any particular period. To date, there have been no material differences from our estimates to the amount actually incurred.
Equity-based Compensation
Equity-based compensation expense represents the grant-date fair value of employee awards recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. We account for awards to non-employees using the fair value approach. Non-employee awards are subject to periodic revaluation over their vesting terms.
Prior to the Conversion, we, through Odonate Management Holdings, LLC (Management Holdings), issued an aggregate of 2,931,402 incentive units under the Odonate Management Holdings Equity Incentive Plan (the Management Plan). The incentive units were issued to certain of our directors, officers, employees and consultants in consideration for bona fide services provided to us. Pursuant to the Management Plan, the incentive units are considered profits interests within the meaning of U.S. federal and state tax rules. Incentive units do not entitle their holders to receive distributions if we were to be liquidated immediately after the grant. Instead, the incentive unitholders are entitled to receive an allocation of a portion of our profits arising after the date of the grant and, subject to vesting conditions, distributions made out of a portion of our profits arising after the grant date of the incentive units. Accordingly, the financial benefits of incentive units to the awardee, and the costs to the issuing company, are substantially similar to a stock option grant. Grants of the incentive units may be fully vested, partially vested or entirely unvested at the time of the grant as determined by the Board. To date, all incentive units have provided for vesting over a 4-year period from either the date of grant or the commencement of service.
After the Conversion, the outstanding incentive units of Management Holdings will remain outstanding, but will represent an indirect interest in the common stock of the Company upon vesting of the awards. As part of the Conversion, the shares of common stock underlying the outstanding incentive units will be issued to a newly formed entity, Odonate Holdings, LLC (Odonate Holdings). While Odonate Holdings will hold the shares underlying outstanding incentive units, it will have no other operations. In addition, Odonate Holdings will grant us an irrevocable proxy directing us to vote all shares held by Odonate Holdings in the same proportion as the vote by all other stockholders, which is sometimes called mirrored voting. In the event that any incentive units in Management Holdings are forfeited, the shares of common stock underlying such forfeited incentive units will be transferred from Odonate Holdings to us and cancelled.
As of December 31, 2016 and September 30, 2017, we had 1,934,716 and 2,365,950 incentive units outstanding, respectively, all of which will become incentive units in Odonate Holdings and represent an indirect right, subject to vesting, in our common stock. The grant-date fair value of incentive units was estimated using a Black-Scholes option-pricing model. We used a volatility and
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risk-free rate of 73% to 79% and 1.3% to 2.5%, respectively, to estimate the fair value of the incentive units. The estimated volatility was based on the historical equity volatility of comparable companies.
As there has been no public market for our common and incentive units, for all periods prior to this offering, the fair value of the common and incentive units were estimated on each grant date by our management. In order to determine the fair value of our common and incentive units, our management considered, among other things, recently available independent valuations, and valuations derived from the sale of our equity securities to third parties in recent equity financings. These independent valuations were performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation .
For valuations after the completion of this offering, our Board will determine the fair value of our equity awards based on the closing price of our common stock as reported on the date of grant, as we expect to be able to rely on the market price to determine the market value of our common stock.
Recent Accounting Pronouncements
In August 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-15, Presentation of Financial StatementsGoing Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entitys Ability to Continue as a Going Concern (ASU 2014-15). The new standard requires management to assess, at each annual and interim reporting period, an entitys ability to continue as a going concern within one year after the date that the financial statements are issued and to provide related footnote disclosures. The amendments are effective for public business entities for fiscal years ending after December 15, 2016. We adopted this guidance during the year ended December 31, 2016 with no material impact on our financial statements.
In February 2016, the FASB issued ASU No. 2016-02, Leases (ASU 2016-02). This guidance requires recognition of lease assets and lease liabilities on the balance sheet and disclosure of key information about leasing arrangements. ASU 2016-02 is effective for annual reporting periods beginning after December 15, 2018 and interim periods thereafter. Early adoption is permitted. The guidance is required to be adopted at the earliest period presented using a modified retrospective approach. We are evaluating the impact the adoption of ASU 2016-02 will have on our financial statements and disclosures.
In March 2016, the FASB issued ASU No. 2016-09, Stock Compensation (ASU 2016-09). This guidance identifies areas for simplification involving several aspects of accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, an option to estimate forfeitures or recognize actual forfeitures as they occur, as well as certain classifications on the statement of cash flows. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016 and interim periods thereafter. We adopted this guidance prospectively during the year ended December 31, 2016 with no material impact on our financial statements and disclosures.
In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (ASU 2016-15). ASU 2016-15 is intended to address how certain cash receipts and cash payments are presented and classified in the statement of cash flows. This update addresses 8 specific cash flow issues with the objective of reducing the existing diversity in practice. The amendments are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early
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adoption is permitted. We adopted this guidance prospectively during the year ended December 31, 2016 with no material impact on our financial statements.
In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (ASU 2016-18). ASU 2016-18 is intended to address diversity in practice that exists in the classification and presentation of changes in restricted cash on the statement of cash flows. The amendments require that a statement of cash flows explain the change during the period in the total of cash, cash equivalents and amounts generally described as restricted cash or restricted cash equivalents. The amendments are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted. We adopted this guidance prospectively during the year ended December 31, 2016 with no material impact on our financial statements.
In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business (ASU 2017-01). The purpose of the amendment is to clarify the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions of assets or businesses. The amendments are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. We are evaluating the impact the adoption of ASU 2017-01 will have on our financial statements and disclosures.
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Company Overview
We are a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer. Our initial focus is on the development of tesetaxel, a novel chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several potential therapeutic advantages over currently available taxanes, including: oral administration with a low pill burden and a patient-friendly dosing regimen; a formulation that does not contain solubilizing agents that are known to cause hypersensitivity (allergic) reactions; and improved activity against chemotherapy-resistant tumors. Tesetaxel has been generally well tolerated in clinical studies and has demonstrated robust single-agent antitumor activity in two Phase 2 studies in patients with locally advanced or metastatic breast cancer (MBC). We expect to begin enrolling patients in our multinational, multicenter, randomized, Phase 3 study in MBC, known as CONTESSA, in the fourth quarter of 2017 and report top-line results from this study in 2020. Our goal for tesetaxel is to develop an effective chemotherapy choice for patients that provides quality-of-life advantages over current alternatives.
Breast Cancer and Its Treatment
Breast cancer is the second-most common cancer worldwide, with an estimated 1.8 million new cases diagnosed per year. In Europe, an estimated 494,000 new cases are diagnosed and approximately 143,000 women will die of the disease each year, making it the leading cause of cancer death in women. In the U.S., an estimated 255,000 new cases are diagnosed and approximately 41,000 women will die of the disease each year, making it the second-leading cause of cancer death in women. Estimated breast cancer incidence and deaths per year in Europe, the U.S. and worldwide are shown in the following table.
Estimated Breast Cancer Incidence and Deaths per Year in Europe, the U.S. and Worldwide
Breast cancer typically is staged (Stage 0-IV) based on the size of the tumor, whether or not the tumor is invasive, whether or not the cancer is in the lymph nodes, and whether or not the cancer has spread (metastasized) to other parts of the body beyond the breast. For most patients diagnosed with early breast cancer who undergo surgical treatment, the prognosis is good; the 5-year survival rate for these patients is approximately 94%. However, the prognosis for patients with MBC (which includes patients who relapsed following surgery as well as patients who are inoperable upon initial diagnosis) remains poor; the 5-year survival rate for metastatic disease is approximately 22%, making MBC an area of continued, high unmet medical need.
Breast cancer is a heterogeneous disease comprised of several molecular subtypes, which are commonly grouped into clinical subtypes based on receptor status. Receptors that are assessed in
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standard clinical practice include the estrogen receptor (ER) and progesterone receptor (PgR), collectively the hormone receptors (HR), and human epidermal growth factor receptor 2 (HER2). Breast cancers generally are categorized by the presence or absence of these receptors. The most common type of breast cancer is HER2 negative and HR positive, accounting for approximately 64% of newly diagnosed cases. HER2 positive breast cancer and triple-negative breast cancer (TNBC), the latter of which lacks all three receptors, are less common, accounting for approximately 13% and 11% of breast cancers, respectively. Estimated U.S. breast cancer incidence by receptor status and MBC treatments by receptor status are shown in the following figure.
Estimated U.S. Breast Cancer Incidence by Receptor Status and MBC Treatments
by Receptor Status
(1) Based on Surveillance, Epidemiology, and End Results (SEER) registry data (2014). |
Current Treatment of HER2 Negative, HR Positive MBC
HER2 negative, HR positive disease, which represents the majority of all MBC cases, remains an area of high unmet medical need. Over the past two decades, only modest survival benefits have been achieved in this patient population; hence, treatment goals emphasize controlling disease-related symptoms, minimizing toxicity and maximizing quality-of-life. Patients with HER2 negative, HR positive disease are typically treated with endocrine therapy (with or without targeted agents such as a cyclin-dependent kinase (CDK) 4/6 inhibitor), chemotherapy or both.
Endocrine Therapy
Endocrine agents, which target certain hormone receptors inside and on the surface of tumor cells with the goal of slowing tumor growth, are preferred as initial treatment prior to chemotherapy for most patients with HER2 negative, HR positive MBC. These agents, which typically are used sequentially with or without targeted agents such as a CDK 4/6 inhibitor, include aromatase inhibitors ( e.g. , anastrozole, exemestane and letrozole), selective estrogen receptor modulators (SERMs; e.g. , tamoxifen) and estrogen receptor downregulators (ERDs; e.g. , fulvestrant).
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The recently approved CDK 4/6 inhibitor, palbociclib, an orally administered therapy, has significantly improved outcomes for patients with MBC when used in combination with endocrine agents. In a multicenter, randomized, Phase 3 study, letrozole plus palbociclib given as initial therapy in post-menopausal women with HER2 negative, ER positive MBC resulted in median progression-free survival (PFS) of 24.8 months, compared to 14.5 months with letrozole alone. And, in a different multicenter, randomized, Phase 3 study, fulvestrant plus palbociclib given as second-line endocrine therapy in women with HER2 negative, HR positive MBC resulted in median PFS of 9.5 months, compared to 4.6 months with fulvestrant alone. Despite these recent advances in endocrine therapy, virtually all MBC patients will eventually progress and require subsequent treatment with chemotherapy.
Chemotherapy
In HER2 negative, HR positive MBC, chemotherapy generally is used following disease progression on endocrine therapy. However, there is also a significant percentage of patients who receive chemotherapy as their first treatment for advanced disease because endocrine therapy is not indicated. This includes patients with: (i) a short relapse-free interval while on adjuvant (immediately following surgery) endocrine therapy (endocrine resistance); (ii) rapidly progressive disease/visceral crisis; and/or (iii) endocrine intolerance. In a recent analysis of a several-thousand-patient record database in Europe and the U.S., chemotherapy-only regimens were given in the first-line setting 33% to 35% of the time in Europe and 34% to 42% of the time in the U.S.
Chemotherapy agents used in the treatment of MBC generally are considered to be associated with significant side effects and a negative impact on quality-of-life. The approved chemotherapy agents for the treatment of HER2 negative MBC include: paclitaxel, nab-paclitaxel and docetaxel (taxanes); capecitabine (a fluoropyrimidine); doxorubicin and epirubicin (anthracyclines); gemcitabine (a nucleoside inhibitor); ixabepilone (an epothilone approved in the U.S.); and eribulin (a non-taxane microtubule dynamics inhibitor). The taxanes and eribulin are approved as monotherapy; capecitabine is approved as both monotherapy and combination therapy (with docetaxel); gemcitabine is approved as combination therapy only (with paclitaxel); and ixabepilone is approved in the U.S. as both monotherapy and combination therapy (with capecitabine).
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The choice and sequencing of chemotherapy regimens depend on a number of factors, including physician preference, previous therapies, pre-existing medical conditions, tumor burden and patient symptoms. As shown in the following chart, capecitabine, an oral chemotherapy and taxanes are the preferred first-line chemotherapy agents in HER2 negative, HR positive MBC.
Physician-reported Preferences for First-line Chemotherapy for Patients with HER2 Negative,
HR Positive MBC from Recent Survey of 201 U.S. Community-based Oncologists
Taxanes
Taxanes are an established class of anticancer agents that are broadly used in various cancers, including breast cancer. Taxanes destroy cancer cells by preventing them from entering mitosis, a process of cell division, and thereby leading to apoptosis, or cell death. As shown in the figure below, taxanes are one of the most widely used classes of chemotherapy agents in both Europe and the U.S., with more than 2.8 million cycles administered in 2016.
>2.8 Million Cycles of Paclitaxel, Nab-paclitaxel and Docetaxel
Administered in 2016 in Europe and the U.S.
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While paclitaxel and docetaxel, the first two taxanes approved for the treatment of breast cancer, possess robust antitumor activity, they have low oral bioavailability and low solubility. Therefore, these pharmaceutical agents must be delivered intravenously, typically at an infusion center, and also are formulated with solubilizing agents that are known to cause hypersensitivity reactions. Nab-paclitaxel, a different formulation of paclitaxel that also is approved for the treatment of breast cancer, has a greatly reduced risk of hypersensitivity reactions, but must still be delivered intravenously. Therapies given |
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intravenously at an infusion center often are associated with:
Fear of needles and associated complications;
Anxiety, including institutional-triggered side effects such as nausea and vomiting;
Heightened awareness of life-threatening disease presence; and
Disruption of daily activities. |
Capecitabine
As the only orally administered chemotherapy routinely used for MBC in the U.S., capecitabine offers quality-of-life advantages over intravenous (IV) chemotherapy alternatives. In each of the 4 following recently published studies in which breast cancer patients were surveyed as to their preference of treatment modality, the authors concluded that patients preferred oral over IV chemotherapy.
Studies of Breast Cancer Patients Preference of Oral vs. IV Chemotherapy
(1) Beusterien et al, The Oncologist 2014 (2) Ishitobi et al, Patient Preference and Adherence 2013 (3) Schott et al, BMC Cancer 2011 (4) Gornas et al, European Journal of Cancer Care 2010 |
Overall, as shown in the figures that follow, the sales of oral therapies in the treatment of cancer have grown at a higher rate than the sales of injectable therapies over the past 8 years, and capecitabine is one of the most widely used chemotherapy agents in both Europe and the U.S., with more than 2.0 million cycles administered in 2016.
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U.S. Market Share of Oral vs. Injectable Cancer Therapies |
>2.0 Million Cycles of Capecitabine, an Oral Chemotherapy Agent, Administered in 2016 in Europe and the U.S. |
|
Tesetaxel: A Chemotherapy with Potential Best-in-Class Properties
Tesetaxel, which we believe will qualify as a New Chemical Entity (NCE) if and when a New Drug Application (NDA) is submitted, retains the same taxane core as the approved taxanes, but includes the addition of two novel, nitrogen-containing functional groups. Tesetaxel is chemically designed to have high oral bioavailability, high solubility, a long terminal half-life, and to not be expelled by the P-gp efflux pump, with the intent of retaining activity against chemotherapy-resistant tumor cells. The table below compares some of the chemical and pharmacologic properties of paclitaxel, docetaxel and tesetaxel.
Chemical and Pharmacologic Properties of Paclitaxel, Docetaxel and Tesetaxel
|
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We believe that tesetaxels unique properties may translate into significant benefits for patients. These may include:
| Oral administration with a low pill burden and a patient-friendly dosing regimen; |
| A formulation that does not contain polyoxyethylated castor oil or polysorbate 80, solubilizing agents contained in other taxane formulations known to cause hypersensitivity reactions; and |
| Durable antitumor activity. |
Preclinical Overview
Tesetaxel has exhibited potent antitumor activity in both in vitro (in a test tube) and in vivo (in a live organism) preclinical studies (Shionoya et al, Cancer Science 2003). Unique among taxanes, tesetaxel retains potent antitumor activity against chemotherapy-resistant tumor cells, including tumor cells over-expressing the P-glycoprotein (P-gp) efflux pump. A defense mechanism of tumor cells, this efflux pump functions to expel toxins, including many chemotherapy agents.
In Vitro Antitumor Activity
Tesetaxel has exhibited potent antitumor activity in in vitro preclinical studies, with an overall GI 50 (the concentration of drug required to inhibit growth by 50%) of less than 1 nM. GI 50 is a commonly used preclinical measurement of antitumor potency; lower GI 50 numbers connote higher potency (1 nM is 1/1,000 th of 1 µM). Of particular note, tesetaxel largely retains antitumor cytotoxic (cell-killing) potency against taxane-resistant (P-gp positive) and other chemotherapy-resistant tumors, while paclitaxel and docetaxel lose considerable antitumor potency (Shionoya et al, Cancer Science 2003). The relative loss of cytotoxic potency between P-gp negative and P-gp positive tumor cells and between non-drug-resistant and drug-resistant tumor cells for paclitaxel, docetaxel and tesetaxel is shown in the following table (low numbers connote high potency, and high numbers connote low potency).
In Vitro Cytotoxic Potency of Paclitaxel, Docetaxel and Tesetaxel in
P-gp Negative, P-gp Positive, Non-drug-resistant and Drug-resistant Tumors
GI 50 = concentration required to inhibit growth by 50% P-gp = P-glycoprotein |
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In Vivo Antitumor Activity
Tesetaxel administered orally exhibited significantly greater growth-inhibitory effects (inhibition rate (IR) > 90%) than paclitaxel and docetaxel administered IV (IR values of 26%-58%) in a mouse model in which P-gp positive, human breast tumors (DU4475) were implanted in mice (Shionoya et al, Cancer Science 2003). The relative in vivo antitumor activity for a control, paclitaxel, docetaxel and tesetaxel is shown in the following graph.
In Vivo Antitumor Activity of Paclitaxel, Docetaxel and Tesetaxel in
P-gp Positive Breast Tumors in Mice
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Clinical Development Program
The tesetaxel Investigational New Drug application (IND) was originally filed by Daiichi Sankyo Company, Limited (Daiichi Sankyo) in 2001 for the treatment of cancer. We are the current sponsor of the tesetaxel IND, which is active. More than 500 patients were treated with tesetaxel between 2001 and 2012 across 22 clinical studies. Tesetaxel was administered as monotherapy in 16 studies and in combination with other agents in 6 studies. Final study data are available for 8 of these studies, while data collection, which was interrupted due to the prior sponsors lack of funding, is underway for 14 of these studies. Studies have been completed in MBC, gastric cancer, colorectal cancer, non-small cell lung cancer and other cancers as first-line, second-line or salvage therapy. Clinical studies that have been conducted with tesetaxel are shown in the following table.
Clinical Studies of Tesetaxel
N = Number of patients treated CRC = Colorectal cancer NSCLC = Non-small cell lung cancer (1) Studies conducted by Genta Incorporated. Patients treated from 2008 to 2012. (2) Studies conducted by Daiichi Sankyo. Patients treated from 2001 to 2006. (3) Includes 46 patients who received tesetaxel once every 21 days. A cohort of 15 patients receiving tesetaxel weekly (days 1, 8 and 15 of a 28-day cycle) was discontinued early due to study termination. In this prospectus, Studies TOB203 and TOB203XT are referred to as Study TOB203. |
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(4) Final study data available. (5) The Phase 1 study in solid tumors was split into Study TOST107, which included data from the first two cycles, and TOST107XT, which included data from patients receiving three or more cycles. In this prospectus, Studies TOST107 and TOST107XT are referred to as Study TOST107. |
Tesetaxel, administered both alone and in combination with capecitabine, has been generally well tolerated. In the 8 studies (927A-PRT001, 927A-PRT004, 927E-PRT003, 927E-PRT005, 927E-PRT007, 927A-PRT006, TOST107 and TOST107XT) for which final study data are available, a total of 268 patients received tesetaxel either alone (222 patients from 5 studies) or in combination with capecitabine (46 patients from three studies). The most common Grade ³ 3 (severe or serious) treatment-related adverse event (AE) was neutropenia (low level of neutrophils, a type of white blood cell), which occurred in 37% of patients receiving tesetaxel alone and 43% of patients receiving tesetaxel in combination with capecitabine and was generally reversible and manageable with supportive measures. Six percent (6%) of patients receiving tesetaxel alone and 11% of patients receiving tesetaxel in combination with capecitabine experienced treatment-related febrile neutropenia (fever coinciding with neutropenia).
Overall, there was no non-hematologic Grade ³ 3 treatment-related AE that occurred in more than 6% of patients. Three percent (3%) of patients receiving tesetaxel alone and 2% of patients receiving tesetaxel in combination with capecitabine experienced Grade ³ 3 treatment-related peripheral neuropathy (weakness, numbness and/or pain from damage to the nerves). No patients receiving tesetaxel alone and 11% of patients receiving tesetaxel in combination with capecitabine experienced Grade ³ 3 treatment-related hand-foot syndrome (redness and swelling of the palms and soles, which may progress to dryness, scaling, pain, itching and sometimes blisters and ulceration). Six percent (6%) of patients receiving tesetaxel alone and 7% of patients receiving tesetaxel in combination with capecitabine experienced Grade ³ 3 treatment-related diarrhea. Seventeen percent (17%) of patients receiving tesetaxel alone and 9% of patients receiving tesetaxel in combination with capecitabine experienced any grade of treatment-related alopecia (hair loss).
The results from the two Phase 2 clinical studies of tesetaxel monotherapy in MBC (TOB203 and 927E-PRT005) are summarized below.
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Studies in Patients with MBC
Study TOB203: A Phase 2 Study of Tesetaxel as First-line Chemotherapy for MBC
In Study TOB203, which was conducted by Genta Incorporated from 2010 to 2012, 46 patients with HER2 negative, HR positive or negative MBC were enrolled to receive, as first-line chemotherapy, tesetaxel administered orally at 27 mg/m 2 (of body surface area: an average female cancer patient is approximately 1.7 m 2 ) on the first day of a 21-day cycle, with escalation to 35 mg/m 2 in subsequent cycles depending on tolerability, without anti-allergy premedication. Objective response rate (ORR) (complete response (disappearance of all target lesions) + partial response (at least a 30% decrease in the sum of the diameters of target lesions)) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 was the primary endpoint.
Median age was 58 years (range: 36-80 years). Twenty percent (20%) of patients had triple-negative disease, and the median time from initial diagnosis was 4 years (range: 0-21 years). Sixty-seven percent (67%) of patients received prior endocrine therapy, and 70% had received prior chemotherapy in the adjuvant setting, with 57% having received a taxane-containing regimen and 52% having received an anthracycline-containing regimen. Common metastatic sites included the lung and lymph nodes (57% of patients each) and the liver and bone (52% each). The figures that follow show the study design and patient characteristics.
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Forty-four (44) of 46 patients received at least one tumor scan (one patient discontinued due to diarrhea, and one patient discontinued due to clinical signs of disease progression) and, therefore, were evaluable for response. The unconfirmed (based on a single scan) ORR was 45% (20 of 44 patients), and the confirmed (based on two tumor scans at least 4 weeks apart in time) ORR was 36% (16 of 44 patients, including one with a complete response and 15 with a partial response). Median PFS was 5.8 months among all treated patients and 7.3 months in patients with HR positive disease. Patient best response (confirmed) is shown in the following figure.
TOB203: Best Response
Antitumor activity by individual patient is shown in the following figure.
TOB203: Maximum Tumor Volume Change from Baseline in Target Lesions
(1) 16 confirmed; 4 unconfirmed |
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Unconfirmed ORR by patient subgroup is shown in the following figure.
TOB203: Unconfirmed ORR by Patient Subgroup
Tesetaxel was generally well tolerated. The starting tesetaxel dose (27 mg/m 2 ) was escalated to 35 mg/m 2 in 19 of 46 patients. Our Phase 3 study will use a dose of 27 mg/m 2 . The most common Grade ³ 3 AE was neutropenia, which was more common in the escalated dose (26% of patients in the non-escalated 27 mg/m 2 dose group and 42% in the 27 mg/m 2 escalated to 35 mg/m 2 dose group). The incidence of Grade ³ 3 febrile neutropenia was 4%. There was no Grade ³ 3 peripheral neuropathy observed in the non-escalated 27 mg/m 2 dose group. The incidence of Grade 2 alopecia (significant hair loss) was 15% and similar in both dose groups. There were no hypersensitivity reactions. A summary of Grade ³ 3 AEs is shown in the following table.
TOB203: Grade ³ 3 Adverse Events
(1) Low level of platelets, a type of blood cell (2) Low level of potassium |
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Study 927E-PRT005: A Phase 2 Study of Tesetaxel as Mixed-line Chemotherapy for MBC
In Study 927E-PRT005, which was conducted by Daiichi Sankyo from 2004 to 2006, 34 patients with MBC were enrolled to receive, as first-, second- or third-line chemotherapy, tesetaxel administered orally at initial doses of 27 mg/m 2 (79% of patients) or 35 mg/m 2 (21% of patients) on the first day of a 21-day cycle. Median age was 52 years (range: 32-80 years), and median time from initial diagnosis of breast cancer was 3.5 years (range: 1-19 years).
Thirty-two percent (32%) of patients had no prior chemotherapy for advanced disease, 65% had one prior chemotherapy regimen for advanced disease, and 3% had two prior chemotherapy regimens for advanced disease. All patients received an anthracycline-based regimen in the adjuvant or metastatic setting. Common metastatic sites included the liver (59% of patients), bone (44%), lymph nodes (26%) and lung (21%).
Thirty-two (32) patients completed at least one cycle of therapy (one patient discontinued due to a pulmonary embolism, which was reported by the investigator as unlikely to be related to study drug, and one patient discontinued due to clinical signs of disease progression) and were included in the efficacy population. The unconfirmed ORR was 38% (12 of 32 patients), and the confirmed ORR was 22% (7 of 32 patients; all partial responses). Median time-to-progression was 3.4 months. Patient best response (confirmed) is shown in the following figure.
927E-PRT005: Best Response
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Seventeen (17) patients for which primary tumor biopsies were evaluated by immunohistochemistry staining were categorized according to their level of P-gp expression. Tumors with high levels of P-gp expression are generally associated with taxane resistance. Response (unconfirmed) by level of P-gp expression for these patients is shown in the following figure.
927E-PRT005: Response by Level of P-gp Expression
Tesetaxel was generally well tolerated. The most common Grade ³ 3 AE was neutropenia (35% of patients). The incidence of Grade ³ 3 febrile neutropenia was 3%, the incidence of Grade ³ 3 peripheral sensory neuropathy (numbness and/or pain from damage to the nerves) was 3% and the incidence of Grade 2 alopecia was 18%. There were no hypersensitivity reactions. A summary of Grade ³ 3 AEs is shown in the following table.
927E-PRT005: Grade ³ 3 Adverse Events
(1) Low level of leukocytes, a type of white blood cell (2) Low level of red blood cells |
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Tesetaxel Efficacy, Tolerability and Dosing Regimen as Compared to Available Chemotherapies
Tesetaxel as a single agent has demonstrated robust antitumor activity in MBC. The antitumor activity of tesetaxel in Study TOB203 as compared to that of paclitaxel and capecitabine as observed in first-line MBC studies is shown in the following table.
Efficacy Measures of Paclitaxel, Capecitabine and Tesetaxel in the
First-line Chemotherapy Treatment of MBC
ORR = Objective response rate; PFS = Progression-free survival; TTP = Time to progression; TTF = Time to treatment failure |
||
(1) |
Study TOB203 | |
(2) |
Randomized, multicenter studies in the first-line chemotherapy treatment of MBC | |
(3) |
Albain et al, Journal of Clinical Oncology 2008; Bishop et al, Journal of Clinical Oncology 1999; Gradishar et al, European Journal of Cancer 2013; Gradishar et al, Journal of Clinical Oncology 2005; Gray et al, Journal of Clinical Oncology 2009; Paridaens et al, Journal of Clinical Oncology 2000 | |
(4) |
Baselga et al, Journal of Clinical Oncology 2012; Goldstein et al, ASCO annual meeting oral presentation 2013; Harbeck et al, Breast Cancer Res Treat 2016; OShaughnessy et al, Annals of Oncology 2001; Robert et al, Journal of Clinical Oncology 2011; Stockler et al, Journal of Clinical Oncology 2011; Twelves et al, Breast Cancer 2016; Vahdat et al, Cancer Research 2009 |
Tesetaxel has been generally well tolerated in clinical studies. The incidence of certain adverse events observed with tesetaxel as compared to those observed with paclitaxel and capecitabine in first-line MBC studies is shown in the following table.
Tolerability of Paclitaxel, Capecitabine and Tesetaxel in the
First-line Chemotherapy Treatment of MBC
NR = Not reported |
||
(1) |
Study TOB203 and, for HFS, an internal report of treatment-related AEs in 222 patients receiving tesetaxel monotherapy | |
(2) |
Randomized, multicenter studies in the first-line chemotherapy treatment of MBC | |
(3) |
Albain et al, Journal of Clinical Oncology 2008; Bishop et al, Journal of Clinical Oncology 1999; Gradishar et al, European Journal of Cancer 2013; Gray et al, Journal of Clinical Oncology 2009; Paridaens et al, Journal of Clinical Oncology 2000 | |
(4) |
Harbeck et al, Breast Cancer Res Treat 2016; OShaughnessy et al, Annals of Oncology 2001; Robert et al, Journal of Clinical Oncology 2011; Stockler et al, Journal of Clinical Oncology 2011 | |
(5) |
Redness and swelling of the palms and soles, which may progress to dryness, scaling, pain, itching and sometimes blisters and ulcerations |
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We believe that an all-oral regimen that may delay the need to receive intravenous chemotherapy in an infusion center will be preferred by patients. Paclitaxel, the most commonly used taxane in the treatment of MBC, generally requires weekly, several-hour visits to an infusion center, where patients must be pretreated with a corticosteroid, an antihistamine and an H 2 antagonist prior to receiving their chemotherapy intravenously. By contrast, tesetaxel monotherapy or tesetaxel plus capecitabine are all-oral regimens that do not require administration in an infusion center.
In comparing tesetaxel monotherapy to capecitabine monotherapy, while both are administered orally, tesetaxel is associated with a low pill burden and a patient-friendly dosing schedule (2-5 pills taken once every 21 days, based on the dosing regimen of tesetaxel in CONTESSA), whereas capecitabine is associated with a high pill burden and a challenging dosing schedule (approximately 84-196 pills per 21-day cycle on a twice-daily schedule). The dosing regimens and patient experience for paclitaxel, capecitabine and tesetaxel are shown in the following table.
Dosing Regimens for Paclitaxel, Capecitabine and Tesetaxel
CONTESSA: A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel in MBC
We are initiating a 600-patient, multinational, multicenter, randomized, Phase 3 study, known as CONTESSA, that will compare tesetaxel (27 mg/m 2 on the first day of a 21-day cycle) plus a reduced dose of capecitabine (1,650 mg/m 2 /day on days 1-14 of a 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m 2 /day on days 1-14 of a 21-day cycle) in patients with HER2 negative, HR positive MBC previously treated with a taxane in the neoadjuvant (prior to surgery) or adjuvant (immediately following surgery) setting. Where indicated, patients must have received an anthracycline and/or endocrine therapy with or without a CDK 4/6 inhibitor. CONTESSAs primary endpoint is PFS assessed by an Independent Radiologic Review Committee (IRC). The study is designed (with 90% statistical power) to detect a 42% improvement in PFS (hazard ratio (the ratio of the rates of occurrence of the endpoint events in the two groups of the study) = 0.71; median PFS 8.5 vs.
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6.0 months). CONTESSAs secondary endpoints are overall survival, objective response rate assessed by IRC, disease control rate (ORR + prolonged ( ³ 24 weeks) stable disease) assessed by IRC and patient reported outcomes (PROs).
CONTESSA Study Design
In designing CONTESSA, we received non-binding advice from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). We believe CONTESSA may serve as a single pivotal study sufficient for product registration, provided that the study demonstrates a statistically significant and clinically meaningful improvement in the primary endpoint, PFS, for tesetaxel plus a reduced dose of capecitabine as compared to the approved dose of capecitabine alone as well as an overall favorable benefit-risk profile for the tesetaxel plus a reduced dose of capecitabine regimen. Generally, a single pivotal study can be sufficient for FDA approval only when the study provides highly reliable and statistically strong evidence of an important clinical benefit and in which confirmation of the result in a second clinical trial would be practically or ethically impossible. There can be no assurance that the outcome of CONTESSA will be sufficient for the approval of tesetaxel by the FDA, EMA or other regulatory agencies or that tesetaxel will be approved at all. We expect to begin enrolling patients in CONTESSA in the fourth quarter of 2017. Our U.S. IND was originally filed by Daiichi Sankyo in 2001 for the treatment of cancer and is active, and we plan to submit clinical trial applications in countries outside of the U.S. in which we plan to enroll patients.
Rationale for CONTESSA Study Design
CONTESSA is designed to evaluate whether tesetaxel plus a reduced dose of capecitabine results in improved PFS with manageable toxicity and favorable quality-of-life compared to the approved dose of capecitabine alone. Tesetaxel plus a reduced dose of capecitabine incorporates two agents with synergistic mechanisms of action and is an all-oral regimen that requires a pill burden that is approximately 30% less than the approved dose of capecitabine alone. Our rationale for the CONTESSA study design includes the following points.
| Capecitabine is a preferred agent as a first- or second-line chemotherapy treatment for patients with HER2 negative, HR positive MBC. Therefore, capecitabine, at the approved dose, is an appropriate control regimen for a registration-enabling Phase 3 study. |
| There is a high unmet medical need for combination chemotherapy regimens with improved benefit-risk profiles. |
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| Combining the approved dose of capecitabine with currently available taxanes results in improved efficacy but with significant toxicity. |
| Preclinical and clinical studies support investigating whether reducing the dose of capecitabine in combination with a taxane will reduce toxicity without a reduction in efficacy. |
| Single-agent tesetaxel has demonstrated antitumor activity in two Phase 2 studies in MBC: TOB203 (first-line chemotherapy) and 927E-PRT005 (mixed-line chemotherapy). |
| In a Phase 1 study (TOST107), the combination of tesetaxel plus a reduced dose of capecitabine was associated with a tolerable AE profile, with minimal overlapping toxicity. |
Capecitabine as an Appropriate Control Regimen
Capecitabine is a preferred agent as a first- or second-line chemotherapy treatment for patients with HER2 negative, HR positive MBC, particularly those previously treated with a taxane in the neoadjuvant, adjuvant or advanced setting. Therefore, capecitabine, at the approved dose, is an appropriate control regimen for a registration-enabling Phase 3 study. The FDA- and EMA-approved capecitabine regimen is 2,500 mg/m 2 on Days 1-14 of a 21-day cycle.
Medical Need for Combination Chemotherapy Regimens with Improved Benefit-risk Profiles
To date, combination chemotherapy regimens generally have not demonstrated superior benefit-risk profiles as compared to single-agent, sequential chemotherapy. Specifically, while currently available combination regimens have been associated with increased PFS and, in the case of docetaxel-capecitabine, increased overall survival, they also have been associated with significantly increased toxicity. As a result, single-agent, sequential chemotherapy remains the standard of care for many patients.
Nonetheless, there remains a large unmet need for chemotherapy regimens, including combination regimens, with improved benefit-risk profiles. In particular, newer combinations that preserve the response rates and PFS of currently available combination regimens, but are better tolerated and easier to take, are needed.
An important reason why there is a need for improved combination chemotherapy regimens is the fact that approximately one-third or more of MBC patients do not receive second-line chemotherapy after progressing on first-line chemotherapy, as shown in the following table. Since these patients, who are not necessarily identifiable when first-line chemotherapy is initiated, do not receive second- or later-line chemotherapy, they could benefit from first-line regimens that can significantly increase PFS with minimal increase in toxicity, including regimens that incorporate two therapeutic agents.
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Percentage of MBC Patients Who Did Not Receive Additional Chemotherapy after
Progressing on First-line Chemotherapy Treatment
EU5 = European Union 5 (France, Germany, Italy, Spain and the United Kingdom) |
||||
(1) Nersesyan et al, ISPOR 17th Annual European Congress 2014 (2) Ray et al, Journal of Clinical Oncology 2012 (3) Robert et al, Journal of Clinical Oncology 2011 (4) Albain et al, Journal of Clinical Oncology 2008 |
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Combining the Approved Dose of Capecitabine with Docetaxel, an Approved Taxane
In a multicenter, randomized Phase 3 study in 511 patients receiving first-, second- or third-line chemotherapy that served as the basis for approval for capecitabine combined with docetaxel in the treatment of MBC, capecitabine at the approved dose of 2,500 mg/m 2 (1,250 mg/m 2 BID) on Days 1-14 of a 21-day cycle combined with docetaxel resulted in superior time to disease progression (TTP) (hazard ratio = 0.65, 95% confidence interval: 0.54-0.78, p=0.0001) and overall survival (OS) (hazard ratio = 0.78, 95% confidence interval: 0.63-0.95, p=0.01) as compared to docetaxel alone. However, there was significant drug-related toxicity on the combination regimen, resulting in a large percentage of dose reductions and discontinuations (59% of patients reduced their dose of docetaxel and 51% reduced their dose of capecitabine). The results of this Phase 3 study are as follows.
A Phase 3 Study Evaluating the Combination of the Approved Dose of Capecitabine and
Docetaxel, an Approved Taxane, in the Treatment of MBC (1)
(1) OShaughnessy et al, Journal of Clinical Oncology 2002 |
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Reducing the Dose of Capecitabine in Combination with a Taxane
Synergy when Combining a Taxane with Capecitabine in Preclinical Studies
Preclinical studies have shown synergy when combining a taxane with capecitabine. Taxanes up-regulate tumor levels of thymidine phosphorylase, the enzyme essential for the activation of capecitabine. Specifically, in two in vivo preclinical studies of breast cancer, the combined administration of capecitabine and docetaxel resulted in antitumor efficacy significantly greater than the sum of the efficacy resulting from either agent administered as monotherapy (see the following figures). Furthermore, the synergy may be tumor-specific, as toxicity as measured by weight loss and effect on peripheral blood cells was minimal. These studies suggest the potential to reduce the dose of capecitabine without loss of efficacy.
Synergy with Taxane-Capecitabine Combinations
Capecitabine at 1/2 MTD
+ Docetaxel at 1/8 MTD (1) (2)
|
Capecitabine at 2/3 MTD
+ Docetaxel at 1/15 MTD (3) (4) |
|||||
MTD = Maximum tolerated dose
(1)
Sawada et al,
Clinical Cancer Research
1998
|
|
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Clinical Studies Evaluating Lower Doses of Capecitabine Combined with a Taxane
Consistent with preclinical findings of synergy between taxanes and capecitabine, clinical studies support investigating the combination of a taxane with a reduced dose of capecitabine such as 1,650 mg/m 2 /day on the first 14 days of a 21-day cycle, the dose of capecitabine chosen for combination with tesetaxel in CONTESSA. In a review of 18 first-line MBC studies of taxane plus capecitabine combinations shown in the following table, there was no apparent loss of efficacy when comparing capecitabine at 1,650 mg/m 2 /day to capecitabine at 2,000 mg/m 2 /day (on the first 14 days of a 21-day cycle). Among these studies, the capecitabine 1,650 mg/m 2 /day dose was the most studied dose less than 2,000 mg/m 2 /day (5/8 studies). According to Lortholary et al in Breast Cancer Research and Treatment , the trend toward improved efficacy with lower doses of capecitabine may result from the significantly lower proportion of patients discontinuing study therapy prematurely because of toxicity, and highlights the importance of administering capecitabine using a schedule that optimizes dose intensity and tolerability.
Clinical Studies Evaluating the Combination of a Taxane with Different Doses of Capecitabine as
First-line Chemotherapy in the Treatment of MBC
|
PFS = Progression-free survival; ORR = Objective response rate; OS = Overall survival | ||
(1) | Days 1-14 of a 21-day cycle | |
(2) | Bachelot et al, Oncology 2011; Campone et al, The Breast Journal 2013; Chitapanarux et al, Asia-Pacific Journal of Clinical Oncology 2012; Fan et al, Annals of Oncology 2013; Liao et al, Chemotherapy 2013; Michalaki et al, Anti-Cancer Drugs 2009; Michalaki et al, Anticancer Research 2010; Venturini et al, Cancer 2003; Wang et al, Cancer 2015; Wardley et al, Journal of Clinical Oncology 2010 | |
(3) | Bisagni et al, Cancer Chemotherapy and Phar m a cology 2013; Luck et al, Breast Cancer Research and Treatment 2015 | |
(4) | Hatschek et al, Breast Cancer Research and Treatment 2012; Lam et al, European Journal of Cancer 2014; Perez et al, Annals of Oncology 2010; Schwartzberg et al, Clinical Breast Cancer 2012; Tonyali et al, Journal of Cancer Research and Clinical Oncology 2013 | |
(5) | Silva et al, Clinical Breast Cancer 2008 |
Tesetaxel Plus a Reduced Dose of Capecitabine Generally Well Tolerated in Phase 1 Study (TOST107)
In a Phase 1 study (TOST107), which was conducted by Genta Incorporated from 2011 to 2012, the safety and tolerability of tesetaxel plus a reduced dose of capecitabine was evaluated in patients with advanced solid tumors. Eight (8) patients received tesetaxel at 27 mg/m 2 orally on the first day of each 21-day cycle plus capecitabine at 1,750 mg/m 2 /day orally on days 1-14 of each 21-day cycle, and 9 patients received tesetaxel at 27 mg/m 2 orally on the first day of each 21-day cycle plus capecitabine at 2,000 mg/m 2 /day orally on Days 1-14 of each 21-day cycle.
Tesetaxel in combination with capecitabine at either 1,750 mg/m 2 /day or 2,000 mg/m 2 /day was generally well tolerated with no indication of overlapping toxicity. The most common Grade ³ 3 AE was neutropenia (47% of patients), which was reversible and manageable with supportive measures. There was a low rate of febrile neutropenia (6% of patients), which only occurred in the tesetaxel 27 mg/m 2 plus capecitabine 2,000 mg/m 2 /day group. The incidence of Grade ³ 3 peripheral neuropathy was 6%, Grade ³ 3 hand-foot syndrome was 6%, and Grade ³ 3 diarrhea was 6%. There was no Grade 2 alopecia, and there were no hypersensitivity reactions.
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In response to drug-related side effects, physicians often reduce the dose of chemotherapy received by cancer patients. This reduction, while improving tolerability, can compromise the efficacy of the treatment. The frequency and extent of dose reductions in Study TOST107 as compared to those in the Phase 3 study that served as the basis for approval for capecitabine combined with docetaxel in the treatment of MBC are shown in the following table.
Dose Reductions for Tesetaxel plus Reduced Dose of Capecitabine
Compared to Those for Docetaxel plus the Approved Dose of Capecitabine
|
(1) Day 1 of a 21-day cycle (2) Days 1-14 of a 21-day cycle (3) TOST107/107XT (4) OShaughnessy et al, Journal of Clinical Oncology 2002 |
|
In summary, we believe that the data support the investigation of tesetaxel at 27 mg/m 2 on the first day of a 21-day cycle plus capecitabine at 1,650 mg/m 2 /day on the first 14 days of a 21-day cycle as a novel, all-oral regimen with a potentially favorable benefit-risk profile for the treatment of patients with HER2 negative, HR positive MBC.
Studies in Patients with Other Forms of Cancer
In three studies conducted by Daiichi Sankyo between 2004 and 2006, tesetaxel as a single agent exhibited antitumor activity in gastric cancer, colorectal cancer (CRC) and non-small cell lung cancer (NSCLC).
| Study 927E-PRT003 was a Phase 2 study in which 35 patients with advanced or metastatic gastric cancer who had failed one previous chemotherapy regimen received single-agent tesetaxel. In this study, the confirmed ORR (as measured by RECIST 1.0), which was the primary endpoint, was 19%. |
| Study 927A-PRT004 was a Phase 2 study in which 71 patients with progressive, locally advanced or metastatic CRC received single-agent tesetaxel. In patients who had failed one previous chemotherapy regimen, the confirmed ORR (as measured by RECIST 1.0), which was the primary endpoint, was 10%. |
| Study 927E-PRT007 was a Phase 2 study in which 34 patients with locally advanced or metastatic NSCLC who had failed one previous chemotherapy regimen for advanced disease received single-agent tesetaxel. In this study, the confirmed ORR (as measured by RECIST 1.0), which was the primary endpoint, was 7%. |
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Competition
The biotechnology and pharmaceutical industries are extremely competitive. Our potential competitors in the field are many in number and include major and mid-sized pharmaceutical and biotechnology companies. Many of our potential competitors have significantly more financial, technical and other resources than we do, which may give them a competitive advantage. In addition, they may have substantially more experience in effecting strategic combinations, in-licensing technology, developing drugs, obtaining regulatory approvals and manufacturing and marketing products. We cannot give any assurances that we can compete effectively with these other biotechnology and pharmaceutical companies. Any products that we may develop or discover will compete in highly competitive markets. Our potential competitors in these markets may succeed in developing products that could render our product candidates obsolete or non-competitive.
Tesetaxel faces significant competition. Multiple chemotherapies are currently available to physicians and patients for the treatment of HER2 negative, HR positive MBC. These include: paclitaxel, nab-paclitaxel and docetaxel (taxanes); capecitabine (a fluoropyrimidine); doxorubicin and epirubicin (anthracyclines); gemcitabine (a nucleoside inhibitor); ixabepilone (an epothilone that is approved in the U.S.); and eribulin (a non-taxane microtubule dynamics inhibitor). The taxanes and eribulin are approved as monotherapy; capecitabine is approved as both monotherapy and combination therapy (with docetaxel); gemcitabine is approved as combination therapy only (with paclitaxel); and ixabepilone is approved in the U.S. as both monotherapy and combination therapy (with capecitabine). In addition, there are novel chemotherapies in development, including new intravenous paclitaxel formulations, such as NantPharmas Cynviloq and Sun Pharmas Taclantis, and novel oral paclitaxel formulations, such as Athenexs Oraxol and Daehwa Pharmaceuticals DHP107. We believe that the extent to which tesetaxel is adopted by the marketplace, if it is approved, will depend on factors such as its safety and tolerability, efficacy, convenience, effect on quality-of-life and cost-effectiveness relative to other treatment alternatives.
Daiichi Sankyo License Agreement
In 2013, we licensed rights to tesetaxel in all major markets from Daiichi Sankyo, the original inventor of the product. Tesetaxel had previously been licensed to Genta Incorporated. Contemporaneous with Daiichi Sankyo granting us a license to tesetaxel, we acquired all rights to tesetaxel held by Genta from Gentas bankruptcy estate. Both Daiichi Sankyo and Genta conducted clinical studies of tesetaxel prior to our acquisition of the rights to this product.
Under the Daiichi Sankyo license agreement, we currently hold exclusive rights to 15 issued patents covering tesetaxel. See BusinessPatents and Proprietary Rights. We are obligated under the license agreement to use commercially reasonable efforts to develop and commercialize tesetaxel in the following countries: France, Germany, Italy, Spain, the United Kingdom and the U.S. We are required to make aggregate future milestone payments of up to $31.0 million, contingent on attainment of certain regulatory milestones, none of which have yet been achieved. Additionally, we will pay Daiichi Sankyo a tiered royalty that ranges from the low to high single digits, depending on annual net sales of tesetaxel. To date, no payments have been made to Daiichi Sankyo under the license agreement. The license agreement and accompanying royalty obligation terminate on a country-by-country basis on the last-to-expire patent in each such country, which we expect will be between 2026 and 2031 in the U.S., 2025 and 2030 in European countries and 2025 and 2030 in Japan, depending on the availability and application of patent term extensions. Either party may terminate the agreement for cause in the event of an uncured material breach (subject to a cure period).
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NCE Exclusivity
We believe that tesetaxel will qualify as an NCE if and when an NDA is submitted. If tesetaxel qualifies as an NCE, we believe that NCE regulatory exclusivity, combined with our intellectual property, assuming the availability of 5 years of patent term restoration under the Hatch-Waxman Act, will provide exclusivity for tesetaxel in all major markets through at least 2031. Separate from patent protection, exclusivity refers to certain delays and prohibitions on approval of competitor drugs available under the statute that attach upon approval of a drug.
Exclusivity in the U.S.
In the U.S., drugs approved by the FDA are eligible for regulatory exclusivity under the Federal Food, Drug, and Cosmetic Act (FDCA), which can delay the approval of generic competition by up to 7.5 years. Specifically, the FDCA provides a 5-year period of non-patent marketing exclusivity within the U.S. to the first applicant to gain approval of an NDA for an NCE. A drug is an NCE if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not accept for review an ANDA or a 505(b)(2) NDA submitted by another company for another version of such drug where the applicant does not own or have a legal right of reference to all of the data required for approval. However, an application may be submitted after 4 years if it contains a certification of patent invalidity or non-infringement. This certification will trigger an automatic 30-month stay in the approval of any generic competition, effectively extending the regulatory exclusivity period to 7.5 years.
NCE exclusivity will not delay the submission or approval of a full NDA. However, an applicant submitting a full NDA would be required to conduct or obtain a right of reference to all of the preclinical studies and adequate and well-controlled clinical studies necessary to demonstrate safety and effectiveness.
Exclusivity in Europe
In Europe, NCEs, sometimes referred to as new active substances, qualify for 8 years of data exclusivity upon marketing authorization and an additional two years of market exclusivity, for a total of 10 years of regulatory exclusivity. This exclusivity, if granted, prevents regulatory authorities in the EU from referring to the innovators data to assess a generic application for 8 years, after which generic marketing authorization can be submitted, and the innovators data may be referenced, but the generic product may not be approved for two years. This 10-year period can be extended to a maximum of 11 years if, during the first 8 years of those 10 years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications that, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.
However, even if a compound is considered to be an NCE and the sponsor is able to gain the prescribed period of data exclusivity, another company nevertheless could also market another version of the drug if such company can complete a full Marketing Authorization Application with a complete database of pharmaceutical tests, preclinical studies and clinical studies and obtain marketing approval of its product.
Exclusivity in Japan
In Japan, an NCE is eligible for at least 8 years of regulatory exclusivity. Specifically, under the Pharmaceutical Affairs Law, the regulatory authority re-examines the safety and efficacy of drugs after drug approval. The data submitted to the regulatory authority is not available to generic drug companies during the re-examination period. This effectively makes the re-examination system a regulatory exclusivity system in Japan. The re-examination period is 10 years following approval for an orphan drug and 8 years for an NCE. Innovators may also benefit from an additional 4- to 10-month
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waiting period for generic pricing approval. There may be an additional 4 years of market protection granted if a new indication for a drug is registered in the first 8 years of the re-examination period.
Patents and Proprietary Rights
The proprietary nature of, and protection for, our product candidates, processes and know-how are important to our business. Our success depends in part on our ability to protect the proprietary nature of our product candidates, technology and know-how, to operate without infringing on the proprietary rights of others and to prevent others from infringing on our proprietary rights. We seek and maintain patent protection in the U.S. and internationally for our product candidates and other technology. We endeavor to patent or in-license technology, inventions and improvements that we consider important to the development of our business. In addition to patent protection, we intend to use other means to protect our proprietary rights, including pursuing terms of marketing or data exclusivity, orphan drug status (if applicable) and similar rights that are available under regulatory provisions in certain territories, including the U.S., Europe and Japan. We also rely on trade secrets, know-how and continuing innovation to develop and maintain our competitive position.
The intellectual property portfolio protecting our tesetaxel program includes 9 U.S., 4 European and 7 Japanese patents, as well as two pending U.S. patent applications and one pending European patent application. Of these, 5 U.S., 4 European and 6 Japanese patents are exclusively licensed to us by Daiichi Sankyo. The 20 issued patents consist of the following:
| Nine (9) U.S. patents, including: (i) two composition-of-matter patents expiring in 2020 and 2026; (ii) 4 method-of-manufacture patents expiring between 2023 and 2031; and (iii) three patents with composition-of-matter, method of manufacture and/or method of use claims expiring between 2031 and 2032, without taking into account any potential patent term restoration. |
| Four (4) European patents, including: (i) two composition-of-matter patents expiring in 2020 and 2022; and (ii) two method-of-manufacture patents expiring in 2022 and 2025, without taking into account any potential patent term restoration. |
| Seven (7) Japanese patents, including: (i) three composition-of-matter patents expiring between 2020 and 2022; (ii) three method-of-manufacture patents expiring between 2022 and 2025; and (iii) one patent with both composition-of-matter and method-of-manufacture claims expiring in 2031, without taking into account any potential patent term restoration. |
Among these patents, one issued U.S. composition-of-matter patent (U.S. Patent No. 7,410,980) covers the crystal form of tesetaxel used in our clinical formulation and will expire in 2026. If tesetaxel is approved by the FDA, we will be entitled to request patent term restoration that could extend the protection of this patent until 2031. The exact duration of the extension depends on the time we spend in clinical studies as well as the time the FDA spends reviewing our NDA. See BusinessGovernment RegulationU.S. Patent Term Restoration.
Our success depends on an intellectual property portfolio that supports our future revenue streams. We are maintaining and building our patent portfolio through filing new patent applications and prosecuting existing applications. We cannot be certain that patents will be granted with respect to any of our pending patent applications or with respect to any patent applications filed by us in the future, nor can we be sure that any of our existing patents or any patents granted to us in the future will be commercially useful in protecting our technology. Any of our intellectual property and proprietary rights could be challenged, invalidated, circumvented, infringed or misappropriated, or such intellectual property and proprietary rights may not be sufficient to permit us to take advantage of current market trends or otherwise to provide competitive advantages. For more information, please see Risks Relating to Intellectual Property.
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Manufacturing
We currently contract with third-party contract development and manufacturing organizations (CDMOs) for the manufacture of tesetaxel and intend to do so in the future. We do not own or operate manufacturing facilities and currently have no plans to build our own clinical- or commercial-scale manufacturing capabilities. Although we rely on CDMOs, we have personnel with extensive manufacturing experience to oversee these contract service providers.
To date, our third-party manufacturers have met our manufacturing requirements. We expect third-party manufacturers to be capable of providing sufficient quantities of tesetaxel to meet anticipated full-scale commercial demands. To meet our projected needs for commercial manufacturing, third parties with whom we currently work might need to increase their scale of production, or we will need to secure alternate suppliers. We believe that there are alternate sources of supply that can satisfy our clinical and commercial requirements, although we cannot be certain that identifying and establishing relationships with such sources, if necessary, would not result in significant delay or material additional costs.
Sales and Marketing
In order to commercialize tesetaxel, if approved, or any other product candidates that we may develop, we must build marketing, sales and distribution capabilities or make arrangements with third parties to perform these services. The commercial infrastructure for oncology products typically consists of a sales force that calls on oncologists, supported by sales management, medical liaisons, internal sales and marketing support and distribution support.
Additional capabilities important to the oncology marketplace include the management of key accounts such as managed care organizations, integrated delivery networks, group-purchasing organizations, specialty pharmacies and government accounts. To develop the appropriate commercial infrastructure, we will have to invest significant amounts of financial and management resources, some of which will be committed prior to any confirmation that any of our product candidates will be approved.
Where appropriate, we may elect in the future to utilize marketing partners, distributors or contract sales forces to assist in the commercialization of tesetaxel.
Government Regulation
Governmental authorities in the U.S., Europe, Japan and other countries where we may seek approval to commercialize tesetaxel extensively regulate the research, development, testing, manufacture, approval and marketing of pharmaceutical products. Our product candidates must be approved by these regulatory authorities before they may be legally marketed in the applicable jurisdictions. The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. Below is a general summary of applicable government regulations affecting our current and planned business activities in the U.S., Europe and Japan.
U.S. Government Regulation
In the U.S., the FDA regulates drugs under the FDCA and its implementing regulations. Failure to comply with the applicable U.S. requirements at any time during the product development or approval process, or after approval, may subject an applicant to administrative or judicial sanctions, any of which could have a material adverse effect on us. These sanctions could include:
| refusal to approve pending applications; |
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| withdrawal of an approval; |
| imposition of a clinical hold; |
| warning or untitled letters; |
| seizures or administrative detention of product; |
| total or partial suspension of production or distribution; or |
| injunctions, fines, restitution, disgorgement, refusal of government contracts or civil or criminal penalties. |
U.S. Drug Approval Process
The process required by the FDA before a pharmaceutical product may be marketed in the U.S. generally involves the following:
| completion of extensive preclinical laboratory tests, in vivo preclinical studies and formulation studies conducted according to Good Laboratory Practices (GLPs) and other applicable regulations; |
| submission to the FDA of an Investigational New Drug (IND) application, which must become effective before human clinical studies may begin; |
| performance of adequate and well-controlled human clinical studies according to Good Clinical Practices (GCPs) and other applicable regulations to establish the safety and efficacy of the product candidate for its intended use; |
| submission to the FDA of a New Drug Application (NDA) or other applications for approval; |
| completion of an FDA pre-approval inspection of the manufacturing facility or facilities to assess compliance with current Good Manufacturing Practices (cGMP) and conformance with the manufacturing-related elements of the application to assure consistent production of the product within required specifications; |
| potential FDA audit of the study sites that generated the data in support of the NDA; and |
| FDA review and approval of the NDA. |
Once a pharmaceutical candidate is identified for development, it enters the preclinical testing stage. Preclinical tests include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies. An IND sponsor must submit the results of the preclinical tests, together with manufacturing information and analytical data, to the FDA as part of the IND. The IND will also include a protocol detailing the objectives of the clinical study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated.
All clinical studies must be conducted under the supervision of one or more qualified investigators in accordance with FDA requirements. An institutional review board (IRB) must review and approve the protocol and will monitor the study until completion. Clinical studies must be conducted under protocols detailing the objectives of the study, dosing procedures, research subject selection, inclusion and exclusion criteria and the safety and effectiveness criteria to be evaluated. Each protocol, and any material amendments to the protocol, must be submitted to the FDA as part of the IND, and sponsors must report to the FDA serious and unexpected adverse reactions in a timely manner. Sponsors also must make certain financial disclosures to the FDA regarding any financial relationships with study investigators.
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Human clinical studies are typically conducted in three sequential phases that may overlap or be combined.
| Phase 1The product candidate is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and elimination. Initial human testing is often conducted in patients for product candidates intended to treat severe or life-threatening diseases, such as cancer, especially when the product candidate may be inherently too toxic to ethically administer to healthy volunteers. |
| Phase 2Clinical studies are performed on a limited patient population intended to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage. |
| Phase 3Clinical studies are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical study sites. These studies are intended to establish the overall risk-benefit ratio of the product and provide an adequate basis for product labeling. A pivotal study is a clinical study that is intended to meet regulatory authority requirements for the evaluation of a product candidates efficacy and safety such that it can be used to justify the approval of the product. |
Human clinical studies are inherently uncertain, and Phase 1, Phase 2 and Phase 3 testing may not be successfully completed or may not be completed at all. The FDA or the sponsor may suspend a clinical study at any time for a variety of reasons, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical study if the clinical study is not being conducted in accordance with the IRBs requirements or if the product candidate has been associated with unexpected serious harm to patients.
The results of product development, preclinical studies and clinical studies, along with descriptions of the manufacturing process, analytical tests and other control mechanisms, proposed labeling and other relevant information are submitted to the FDA as part of an NDA requesting approval to market the product. Within 60 days following submission of the application, the FDA reviews the NDA to determine if it is substantially complete before the agency accepts it for filing. The FDA may refuse to accept any NDA that it deems incomplete or not properly reviewable at the time of submission, and may request additional information. Once the submission is accepted for filing, the FDA begins an in-depth, substantive review of the NDA, which includes an assessment of the preclinical and clinical data, the products formulation and manufacturing, and whether the product is safe and effective for the proposed intended use. The review timeline for NDAs for new molecular entities is 10 months from the date the application is accepted for filing for a standard review; and 6 months from the date the application is accepted for filing for a priority review.
FDA Expedited Review and Approval
The FDA has various programs, including fast-track designation, breakthrough therapy designation, accelerated approval and priority review, which are intended to facilitate and expedite the development and review of new drugs to address unmet medical needs in the treatment of serious or life-threatening conditions. Different qualifying criteria apply to each program, and each program offers different mechanisms to expedite the development or approval process, such as additional opportunities to meet with the FDA regarding the product candidates clinical development program, the opportunity for rolling review of a marketing application, approval based on a surrogate endpoint or, in the case of priority review, a shorter timeline for reviewing a marketing application. We may seek to take advantage of one or more of these expedited programs for tesetaxel or other product candidates in the future. However, even if a product candidate qualifies for one or more of these programs, the development or approval of the product candidate may not be shortened. The FDA may also later
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determine that a product candidate no longer meets the criteria for designation, and designation does not guarantee that the FDA will ultimately approve the product.
U.S. Patent Term Restoration
Depending on the timing, duration and specifics of FDA approval of the use of our product candidates, one of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent restoration term of up to 5 years as compensation for patent term lost during product development and the FDA regulatory review process, provided the patent term restoration does not extend the remaining term of a patent beyond a total of 14 years from the products approval date. In the future, if available, we intend to apply for an extension of patent term for one of our currently owned patents beyond its current expiration date; however, there can be no assurance that any such extension will be granted to us.
U.S. Post-Approval Requirements
Once an approval is granted, the FDA may withdraw the approval for various reasons, such as non-compliance with regulatory requirements or significant safety and performance problems with the product. Later discovery of previously unknown problems with a product may result in recalls or restrictions on the product or even complete withdrawal of the product from the market. Holders of an approved NDA are required to report certain adverse reactions to the FDA and maintain pharmacovigilance programs to proactively look for these adverse events. Manufacturers are also required to comply with restrictions on the advertising and promotion of their products, including restrictions on off-label promotion for uses outside those described in the approved product labeling.
In addition, after a product candidate has been approved, the FDA may require that certain additional post-approval requirements be satisfied, including the conduct of additional clinical studies. Certain changes to an approved product, such as adding new indications, making certain manufacturing changes or making certain additional labeling claims are subject to further FDA review and approval. Before a company can market products for additional indications, it must obtain approval from the FDA of a new NDA or NDA supplement, which generally requires that additional clinical studies be conducted. A company cannot be sure that any additional approval for new indications for any product candidate will be approved on a timely basis, or at all.
Changes to the manufacturing process for a given drug are strictly regulated and, depending on the significance of the change, may require FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements on us and any third-party manufacturers we use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance and be subject to periodic or for-cause inspection by the FDA and other regulatory authorities to ensure such compliance.
U.S. Reimbursement and Pricing
Significant uncertainty exists as to the coverage and reimbursement status of tesetaxel and any other products for which we may seek regulatory approval. Sales in the U.S. will depend in part on the availability of adequate financial coverage and reimbursement from third-party payors, which include government health programs such as Medicare, Medicaid, TRICARE and the Veterans Administration, as well as managed care organizations and private health insurers. Prices at which we or our customers seek reimbursement for our product candidates can be subject to challenge, reduction or denial by payors.
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The process for determining whether a payor will provide coverage for a product is typically separate from the process for setting the reimbursement rate that the payor will pay for the product. Third-party payors may limit coverage to specific products on an approved list or formulary, which might not include all of the FDA-approved products for a particular indication. Also, third-party payors may refuse to include a particular branded drug on their formularies or otherwise restrict patient access to a branded drug when a less costly generic equivalent or other alternative is available. Medicare Part D, Medicares outpatient prescription drug benefit, contains protections to ensure coverage and reimbursement for oral oncology products, and all Part D prescription drug plans are required to cover substantially all oral anti-cancer agents. However, a payors decision to provide coverage for a product does not imply that an adequate reimbursement rate will be available.
Private payors often rely on the lead of the governmental payors in rendering coverage and reimbursement determinations. Sales of our product candidates will therefore depend substantially on the extent to which the costs of our products will be paid by third-party payors. Achieving favorable coverage and reimbursement from the Centers for Medicare and Medicaid Services (CMS) and/or the Medicare Administrative Contractors is typically a significant gating issue for successful introduction of a new product.
Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy. In order to obtain coverage and reimbursement for any product that might be approved for marketing, we may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of any products, which would be in addition to the costs expended to obtain regulatory approvals. Third-party payors may not consider our product candidates to be medically necessary or cost-effective compared to other available therapies, or the rebate percentages required to secure favorable coverage may not yield an adequate margin over cost or may not enable us to maintain price levels sufficient to realize an appropriate return on our investment in drug development.
U.S. Healthcare Fraud and Abuse Laws and Compliance Requirements
We are subject to various federal and state laws targeting fraud and abuse in the healthcare industry. These laws may impact, among other things, our proposed sales and marketing programs. In addition, we may be subject to patient privacy regulation by both the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include:
| The federal Anti-Kickback Statute, which prohibits, among other things, persons from soliciting, receiving, offering or paying 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, an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs. The term remuneration has been broadly interpreted to include anything of value, including for example gifts, cash payments, donations, the furnishing of supplies or equipment, waivers of payment, ownership interests, and providing any item, service or compensation for something other than fair market value. Federal false claims and civil monetary penalties laws, including the federal civil False Claims Act, which prohibits anyone from, among other things, knowingly presenting, or causing to be presented, for payment to federal programs (including Medicare and Medicaid) claims for items or services that are false or fraudulent. Although we may not submit claims directly to payors, manufacturers can be held liable under these laws in a variety of ways. These include: providing inaccurate billing or coding information to customers or improperly promoting a products off-label use; violating the Anti-Kickback Statute; or misreporting pricing information to government programs. |
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| Provisions of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), which created new federal criminal statutes that prohibit, among other things, knowingly and willfully executing a scheme to defraud any healthcare benefit program or making false statements in connection with the delivery of or payment for healthcare benefits, items or services. |
| The federal Physician Payment Sunshine Act requirements, under the Patient Protection and Affordable Care Act, which require manufacturers of certain drugs and biologics to track and report to CMS payments and other transfers of value they make to U.S. physicians and teaching hospitals as well as physician ownership and investment interests in the manufacturer. |
| Provisions of HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, which impose certain requirements relating to the privacy, security and transmission of individually identifiable health information. |
| Section 1927 of the Social Security Act, which requires that manufacturers of drugs and biological products covered by Medicaid report pricing information to CMS on a monthly and quarterly basis, including the best price available to any customer of the manufacturer, with certain exceptions for government programs, and pay prescription rebates to state Medicaid programs based on a statutory formula derived from reported pricing information. State law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers, state transparency reporting and compliance laws; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and which may not have the same effect, thus complicating compliance efforts. |
European Government Regulation
In Europe, tesetaxel and any future products we may seek to develop and commercialize may also be subject to extensive regulatory requirements. As in the U.S., medicinal products can only be marketed if a marketing authorization from the competent regulatory authorities has been obtained.
Similar to the U.S., the various phases of preclinical and clinical research in Europe are subject to significant regulatory controls. Although the EU Clinical Trials Directive 2001/20/EC has sought to harmonize the EU clinical trials regulatory framework, setting out common rules for the control and authorization of clinical trials in the EU, the EU Member States have transposed and applied the provisions of the Directive differently. This has led to significant variations in the member state regimes. Under the current regime, before a clinical study can be initiated, it must be approved in each of the EU countries where the study is to be conducted by two distinct bodies: The National Competent Authority (NCA) and one or more Ethics Committees (EC). Under the current regime, all suspected unexpected serious adverse reactions to the investigated drug that occur during the clinical study have to be reported to the NCA and ECs of the Member State where they occurred.
In 2014, a new Clinical Trials Regulation 536/2014, replacing the current Directive, was adopted. The new Regulation will become directly applicable in all EU Member States (without national implementation) once the EU Portal and Database are fully functional. It is expected that the Regulation will apply in 2019. The new Regulation seeks to simplify and streamline the approval of clinical studies in the EU. For example, the sponsor shall submit a single application for approval of a clinical study via the EU Portal. As part of the application process, the sponsor shall propose a reporting Member State, which will coordinate the validation and evaluation of the application. The reporting Member State shall consult and coordinate with the other concerned Member States. If an
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application is rejected, it can be amended and resubmitted through the EU Portal. If an approval is issued, the sponsor can start the clinical study in all concerned Member States. However, a concerned Member State can, in limited circumstances, declare an opt-out from an approval. In such a case, the clinical study cannot be conducted in that Member State. The Regulation also aims to streamline and simplify the rules on safety reporting, and introduces enhanced transparency requirements such as mandatory submission of a summary of the clinical study results to the EU Database.
European Drug Approval Process
In the European Economic Area (EEA), which is comprised of the 28 Member States of the EU plus Norway, Iceland and Liechtenstein, medicinal products can only be commercialized after obtaining a Marketing Authorization (MA). There are two types of marketing authorizations:
| The Community MA, which is issued by the European Commission through the Centralized Procedure, based on the opinion of the Committee for Medicinal Products for Human Use (CHMP), of the EMA and which is valid throughout the entire territory of the EEA. The Centralized Procedure is mandatory for certain types of drugs, such as biotechnology medicinal drugs, orphan medicinal drugs and medicinal drugs containing a new active substance indicated for the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and viral diseases. The Centralized Procedure is optional for drugs containing a new active substance not yet authorized in the EEA, or for drugs that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public health in the EU. Under the Centralized Procedure in the EU, the maximum timeframe for the evaluation of a marketing authorization application is 210 days (excluding clock stops, when additional written or oral information is to be provided by the applicant in response to questions asked by the CHMP). Accelerated evaluation might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of a major public health interest, defined by three cumulative criteria: the seriousness of the disease ( e.g. , disabling or life-threatening diseases) to be treated; the absence or insufficiency of an appropriate alternative therapeutic approach; and anticipation of high therapeutic benefit. In this circumstance, EMA ensures that the opinion of the CHMP is given within 150 days, excluding clock stops. |
| National MAs, which are issued by the competent authorities of the Member States of the EEA and only cover their respective territory, are available for drugs not falling within the mandatory scope of the Centralized Procedure. Where a drug has already been authorized for marketing in a Member State of the EEA, this National MA can be recognized in another Member States through the Mutual Recognition Procedure. If the drug has not received a National MA in any Member State at the time of application, it can be approved simultaneously in various Member States through the Decentralized Procedure. Under the Decentralized Procedure, an identical dossier is submitted to the competent authorities of each of the Member States in which the MA is sought, one of which is selected by the applicant as the Reference Member State (RMS). Within 210 days after receipt of a valid application, the competent authority of the RMS prepares a draft assessment report, a draft summary of the drug characteristics (SPC) and a draft of the labeling and package leaflet, which are sent to the other Member States (referred to as the Member States Concerned) for their approval. Within 90 days of receiving the reference member states assessment report and related materials, each concerned member state must decide whether to approve the assessment report and related materials. If the Member States Concerned raise no objections, based on a potential serious risk to public health, to the assessment, SPC, labeling or packaging proposed by the RMS, the drug is subsequently granted a national MA in all the Member States ( i.e. , in the RMS and the Member States Concerned). |
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Under the above described procedures, before granting the MA, the EMA or the competent authorities of the Member States of the EEA make an assessment of the risk-benefit balance of the drug on the basis of scientific criteria concerning its quality, safety and efficacy.
Patent Term Extension in Europe
Similar to the patent term extensions available in the U.S., European patent law offers the possibility to apply for a supplementary protection certificate (SPC) in order to compensate patent holders for the regulatory delays caused by marketing authorization procedures for medicinal products. SPCs extend the patent term for a period that is equal to the time that elapsed between the filing date of the patent application and the date of the first marketing authorization in the EU, minus 5 years. The overall term of an SPC may not exceed 5 years. An SPC may afford a maximum patent duration of 25 years or, when calculated from the date of first marketing approval, an effective patent exclusivity period of 15 years after first marketing authorization. Applications for SPCs must be filed and approved on a country-by-country basis.
Pharmaceutical Coverage, Reimbursement and Pricing in Europe
In Europe, similar political, economic and regulatory developments may affect our ability to profitably commercialize tesetaxel or any other products, if approved. European countries vary significantly in their approach to coverage, reimbursement and pricing assessments. Some countries allow drug products to be marketed only after a reimbursement price has been agreed to. Some countries may require the completion of additional studies that compare the cost-effectiveness of a particular drug candidate to currently available therapies, or so-called health technology assessments, in order to obtain reimbursement or pricing approval. The considerations in each country can also vary with respect to the value placed on unmet need, generic availability, dosing, administration, level of innovation and many other dynamics. In certain cases, these decisions are made sequentially and are often interdependent. Many also have multi-layered, decision-making bodies at the country, regional, local and even hospital level, with various responsibilities within the process.
For example, the United Kingdom typically bases reimbursement decision on a determination of cost effectiveness as defined by cost per quality-adjusted life year (QALY), as assessed by National Institute for Health and Care Excellence (NICE). Funding by the National Health Service (NHS) is typically granted on an incremental cost-effectiveness ratio (ICER) of £30,000 or less per QALY. Unlike other countries, the United Kingdom does have a specific process for cancer therapies that do not gain NICE recommendation initially. Cancer therapies can enter into a conditional reimbursement agreement for no more than two years funded by the Cancer Drug Fund (CDF) while clinical value continues to be assessed in order to inform the final guidance. At the end of this two-year period, recommendation may be granted for permanent reimbursement upon fulfillment of the evidence commitment by the manufacturer.
Similarly, Germany also makes reimbursement decisions based on the determination of additional benefit. Unlike the ICER approach, an efficiency frontier of the total cost and total benefit of all available agents is employed as a cost-benefit methodology. Newly approved agents are compared in terms of cost-benefit ratio either against alternatives or within a specific indication.
France has its own system of therapeutic index to assess medicines for reimbursement and pricing. Reimbursement is determined through a Service Médical Rendu (SMR) rating of clinical benefit (low, moderate, substantial), with the exception of hospital-only drugs that may be reimbursed at 100%. Pricing is negotiated based on an Amélioration du Service Médical Rendu (ASMR) rating of therapeutic improvement compared to available alternatives (negative (VI), no improvement (V), minor (IV), moderate (III), substantial (II), major (I)).
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It is possible that we may be required to conduct cost-effectiveness studies of our product candidates relative to other available therapies in certain countries. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our financial results may suffer.
Japanese Government Regulation
Tesetaxel and any future products we may seek to develop and commercialize will also be subject to extensive regulatory requirements in Japan. As in the U.S., medicinal products can only be marketed if a marketing authorization from the competent regulatory authorities has been obtained. In Japan, the Ministry of Health, Labor, and Welfare (MHLW) oversees the regulation and safety of pharmaceuticals, medical devices, cosmetics and food and is the organizational body responsible for approving or rejecting an NDA. Within MHLW, the Pharmaceuticals and Medical Devices Agency (PMDA) oversees regulatory affairs for drugs and medical devices and is the body responsible for regulatory review of NDAs.
Japanese Drug Approval Process
The drug approval process in Japan involves a series of activities, including preclinical and clinical (Phase 1, 2 and 3) studies, bridging studies, submission of an NDA by the manufacturer, and review of the NDA by the PMDA. MHLW and PMDA are the main regulatory authorities regulating clinical studies. To conduct a clinical study, a pharmaceutical company must register a protocol with MHLW. Prior to submitting a protocol to the MHLW, an applicant usually submits a Clinical Trial Notification (CTN) to the PMDA. All documents must be translated into Japanese. The notification mainly consists of a description and product summary, preclinical data, the clinical study protocol, analysis plan, SOPs, contact person and the names of participating research institution(s). Also, compliance with Good Clinical Practice (GCP) often requires an Institutional Review Board (IRB) to review the clinical study protocol, provide written informed consent forms for participants and report adverse events.
In order to obtain marketing approval, an applicant must submit an NDA for drug marketing authorization to the PMDA for review. Once the PMDA has received the NDA, a team of reviewers evaluates the application data, including quality, pharmacology, pharmacokinetics, toxicology, clinical implications, biostatistics and GCP on-site inspection. During the review process, the reviewers exchange opinions with external experts (expert meetings) to discuss important problems. A general review conference attended by team members, external experts and representatives of the applicant is held after the expert meeting. After the review, the PMDA makes a recommendation and sends the application to the MHLW. MHLW then obtains a recommendation from the Pharmaceutical Affairs and Food Sanitation Council (PAFSC) before making a decision regarding approval or rejection of the application.
When data from clinical studies performed in foreign countries are used for an NDA in Japan, the data are first checked to assure that it complies with legal requirements in Japan. Following the legal assessment, an evaluation to determine whether or not the drug is apt to be affected by ethnic factors (intrinsic or extrinsic factors) is conducted. When necessary, a bridging study in Japanese patients is performed, and, when it is concluded that the clinical study outcome in a foreign population can be extrapolated to the Japanese population, the foreign data can be accepted. It is mandatory to conduct pharmacokinetic studies in Japanese people.
Drug approval reviews are normally processed in the order in which the application forms are received. However, orphan drugs and other drugs considered to be especially important from a medical standpoint, such as new drugs to treat serious diseases, may be designated for priority review.
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Products for priority review are given priority at each stage of the review process as much as possible. For example, for products designated for priority review at the development stage, it is possible to obtain priority interview advice on indications and other items concerning the designated product. The target review period for priority review is 9 months, compared to 12 months for standard reviews.
Patent-term Extension in Japan
The term of a patent that covers an approved drug may be extended for the shorter of 5 years, or the period during which the patent could not be exploited due to obtaining regulatory approval. This period is calculated from the later of the patent registration date (grant date) or the clinical study start date to the regulatory approval date. Unlike in the U.S., patent-term extension in Japan can be applied to more than one patent.
Pharmaceutical Coverage, Reimbursement and Pricing in Japan
In Japan, there is significant uncertainty as to the reimbursement and pricing status of tesetaxel and any other products for which we may seek regulatory approval. Japanese pricing of prescription pharmaceuticals is subject to tight government control. Drug prices are set both according to standardized formulas and through negotiations between government officials and applicant companies on a product-by-product basis. In those negotiations, the level of innovation, usefulness and marketability are important determinants of price. With few exceptions, the Japanese MHLW sets the reimbursement prices for all newly launched prescription drugs in Japan.
There are currently three main pricing methodologies, which are dependent on the number of similar products available. The Cost Calculation Method applies to first-to-market products and is based on manufacturer cost inputs as well as international reference markets. Comparison Method I applies to products with less than three non-generic competitors and allows for premiums based on innovation, usefulness and marketability among others, plus an adjustment to international reference markets. Comparison Method II is reserved for products with three or more non-generic competitors and anchors price to the lowest competitor in the basket, with only downward adjustments possible to the international reference markets. Over 80% of products in Japan are priced through Comparison Method I.
In order to control the proportion of the countrys total healthcare expenditure that is devoted to drugs, the government mandates revisions in the prices of all prescription drugs every two years. However, pricing reform introduced in 2016 may have an impact on the commercial landscape in future years. There are three main changes in discussion, including annual pricing reviews, the addition of a cost-effectiveness analysis, and the huge sellers provision to reduce budget risk for expensive drugs with significant budget impact. These are expected to go into effect in 2018, with additional proposals under consideration for later roll out, including annual reference pricing, indication expansion discounts and optimal use guidelines. These changes may impact the timeline for pricing negotiations as well as the result of these negotiations. The adoption of more restrictive pricing and reimbursement policies along with existing controls could limit our commercial revenue in the Japanese market.
Rest of the World Regulation
For other countries outside of the U.S., EU and Japan, such as Eastern Europe, Latin America, Asia and emerging markets, the requirements governing the conduct of clinical studies, drug licensing, pricing and reimbursement vary from country to country. In all cases, clinical studies must be conducted in accordance with GCP requirements and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.
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Corporate Conversion
We are currently a Delaware limited liability company named Odonate Therapeutics, LLC, and we have operated our business through this Delaware limited liability company. In connection with this offering, prior to the effectiveness of the registration statement of which this prospectus forms a part, we will convert from a Delaware limited liability company into a Delaware corporation by filing a certificate of conversion with the Delaware Secretary of State, and we will change our name from Odonate Therapeutics, LLC to Odonate Therapeutics, Inc. (the Conversion). Prior to the Conversion, we expect that all of the members of Odonate Therapeutics, LLC will contribute their membership units to a newly formed holding company named Odonate Holdings, LLC (Odonate Holdings). Upon effecting the Conversion, the membership interests of Odonate Therapeutics, LLC will be converted into shares of Odonate Therapeutics, Inc., and these shares will be distributed to the members of Odonate Holdings, with Odonate Holdings retaining record title to 2,931,402 shares of Odonate Therapeutics, Inc., which represents the common stock underlying outstanding incentive units previously granted to employees, officers, directors and consultants by Odonate Management Holdings, LLC.
After converting to a corporation and changing our name to Odonate Therapeutics, Inc., we will be governed by a certificate of incorporation to be filed with the Delaware Secretary of State and our bylaws. Upon the effectiveness of the Conversion, the members of the Board of Odonate Therapeutics, LLC will become the members of the Board of Odonate Therapeutics, Inc., and the officers of Odonate Therapeutics, LLC will become the officers of Odonate Therapeutics, Inc.
References throughout this prospectus to our stockholders include the holders of stock that is offered and sold in this offering as well as holders of Odonate Therapeutics, LLC membership units that are converted into Odonate Therapeutics, Inc. common stock as a result of the Conversion.
Implications of Being an Emerging Growth Company
As a company with less than $1.07 billion in annual gross revenue during our last fiscal year, we qualify for and intend to be an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012 (JOBS Act). An emerging growth company may take advantage of specified reduced reporting and other regulatory requirements for up to 5 years that are otherwise applicable to public companies. These reduced reporting provisions include, among others:
| a requirement to present only two years of audited financial statements and only two years of related Managements Discussion and Analysis of Financial Condition and Results of Operations disclosure; |
| an exemption from the auditor attestation requirement on the effectiveness of our system of internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002, as amended (Sarbanes-Oxley Act); |
| an exemption from the adoption of new or revised financial accounting standards until they would apply to private companies; |
| an exemption from compliance with any new requirements adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation or a supplement to the auditors report in which the auditor would be required to provide additional information about the audit and the financial statements of the issuer; |
| an exemption from the requirement to seek non-binding advisory votes on executive compensation and golden parachute arrangements; and |
| reduced disclosure about executive compensation arrangements. |
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We have elected to take advantage of the scaled disclosure requirements and other relief described above or elsewhere in the prospectus so long as we are an emerging growth company. We will remain an emerging growth company for 5 years unless, prior to that time, we: (i) have more than $1.07 billion in annual gross revenue; (ii) have a market value for our common stock held by non-affiliates of more than $700 million as of the last day of our second fiscal quarter of any fiscal year; or (iii) issue more than $1.0 billion of non-convertible debt over a three-year period. We have availed ourselves of the reduced reporting obligations with respect to audited financial statements and related Managements Discussion and Analysis of Financial Condition and Results of Operations and executive compensation disclosure in this prospectus, and expect to continue to avail ourselves of the reduced reporting obligations available to emerging growth companies in future filings with the U.S. Securities and Exchange Commission (SEC).
Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the U.S. Securities Act of 1933 (Securities Act) for complying with new or revised accounting standards. An emerging growth company can therefore delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. However, we are choosing to opt out of such extended transition period and, as a result, we will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-emerging growth companies. Section 107 of the JOBS Act provides that our decision to opt out of the extended transition period for complying with new or revised accounting standards is irrevocable.
As a result of our decision to avail ourselves of certain provisions of the JOBS Act, the information that we provide may be different than what you may receive from other public companies in which you hold an equity interest.
Employees
As of the date of this prospectus, we had 50 employees. None of our employees are represented by labor unions or covered by collective bargaining agreements. We consider our relationship with our employees to be good.
Research and Development
We recognized $0 and $2.6 million in research and development expense in the years ended December 31, 2015 and 2016, respectively, and $0.9 million and $14.9 million in research and development expense for the nine months ended September 30, 2016 and 2017, respectively.
Facilities
Our offices are located at 4747 Executive Drive, Suite 510, San Diego, CA 92121.
Legal Proceedings
We are not currently a party to any material legal proceedings.
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Executive Officers, Directors and Key Employees
The following table sets forth certain information regarding our executive officers, directors and key employees as of the date of this prospectus.
Name |
Age |
Position |
||
Kevin C. Tang |
50 | Chairman and Chief Executive Officer | ||
Jeff L. Vacirca, M.D. |
48 | Vice Chairman | ||
Aaron I. Davis (1),(2),(3) |
39 | Director | ||
Craig A. Johnson (1),(2),(3) |
56 | Director | ||
Robert H. Rosen |
61 | Director | ||
George F. Tidmarsh, M.D., Ph.D. |
57 | Director | ||
Robert D. Millham |
55 | Chief Operating Officer | ||
Joseph P. OConnell, M.D. |
63 | Chief Medical Officer | ||
John G. Lemkey |
37 | Chief Financial Officer | ||
Stewart M. Kroll |
59 | Senior Vice President of Biometrics | ||
Thomas Wei |
41 | Senior Vice President of Research and Strategy | ||
Natasha M. Bartasch-Price |
38 | Vice President of Program Management | ||
Nicole H. Gollaher, J.D. |
48 | Vice President of Legal Affairs | ||
Valerie L. Legagneur |
43 | Vice President of Clinical Operations | ||
Steven S. Pfeiffer, Ph.D. |
42 | Vice President of Technical Operations |
(1) | Member of the Audit Committee. |
(2) | Member of the Compensation Committee. |
(3) | Member of the Nominating and Corporate Governance Committee. |
The following is a biographical summary of the experience of our executive officers, directors and key employees:
Kevin C. Tang
Mr. Tang has served as our Chairman and Chief Executive Officer since the Companys inception in 2013. Mr. Tang also serves as President of Tang Capital Management, LLC, a life sciences-focused investment company he founded in 2002 and an affiliate of the Company. Since 2014, Mr. Tang has served as a director and Chairman of La Jolla Pharmaceutical Company. Since 2009, Mr. Tang has served as a director of Heron Therapeutics, Inc. and, since 2012, has served as Chairman. From 2009 through its acquisition by Endo Pharmaceuticals, Inc. in 2010, he served as a director of Penwest Pharmaceuticals Co. In 2006, Mr. Tang co-founded Ardea Biosciences, Inc. and served as a director from inception through its acquisition by AstraZeneca PLC in 2012. From 2001 to 2008, he was a director of Trimeris, Inc. From 1993 to 2001, Mr. Tang held various positions at Deutsche Banc Alex Brown, Inc., an investment banking firm, most recently serving as Managing Director and head of the firms Life Sciences research group. Mr. Tang received a B.S. degree from Duke University. The Board has concluded that Mr. Tang should serve as a director based on his experience forming and building biotechnology companies, serving as a director of numerous biotechnology companies and serving as a manager of funds specializing in the area of life sciences.
Jeff L. Vacirca, M.D.
Dr. Vacirca has served as our Vice Chairman since July 2016, as a director since January 2017, and, from March 2017 to September 2017, served as our Chief Medical Officer. Since 2008, Dr. Vacirca has served as Chief Executive Officer and Managing Partner/Director of Clinical Research at New York Cancer Specialists. Since 2014, he has served on the Scientific Advisory Board of Caris
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Life Sciences. Dr. Vacirca currently serves as the President of Community Oncology Alliance, a non-profit organization dedicated to advocating for community oncology practices and patients with cancer. Dr. Vacirca received a B.A. degree in human biology from the University at Albany and an M.D. degree from St. Georges University. The Board has concluded that Dr. Vacirca should serve as a director based on his substantial business experience and clinical expertise in oncology.
Aaron I. Davis
Mr. Davis has served as a director since December 2016. Mr. Davis has been the Chief Executive Officer of Boxer Capital, the healthcare arm of Tavistock Group, since 2012. Mr. Davis co-founded Boxer Capital in 2005 and, prior to being appointed Chief Executive Officer, served as Portfolio Manager. Since 2016, Mr. Davis has served as a director of CiVi Biopharma, Inc. From 2006 to 2008, he served as a director of Kalypsys, Inc. From 2000 to 2004, Mr. Davis worked in the Global Healthcare Investment Banking and Private Equity Group at UBS Warburg, LLC. Mr. Davis received an M.A. degree in biotechnology from Columbia University and a B.B.A. degree in finance from Emory University. The Board has concluded that Mr. Davis should serve as a director based on his experience serving as a director of biotechnology companies and as a manager of funds specializing in the area of life sciences.
Craig A. Johnson
Mr. Johnson has served as a director since July 2017. Mr. Johnson also is a director of Heron Therapeutics, Inc., La Jolla Pharmaceutical Company, Mirati Therapeutics, Inc. and GenomeDx Biosciences, Inc. Mr. Johnson also served as a director of Ardea Biosciences, Inc. from 2008 until its acquisition by AstraZeneca PLC in 2012, and as a director of Adamis Pharmaceuticals Corporation from 2011 to 2014. From 2011 to 2012, he served as Chief Financial Officer of PURE Bioscience, Inc., and, from 2010 to 2011, Mr. Johnson served as Senior Vice President and Chief Financial Officer of NovaDel Pharma Inc. From 2004 through its acquisition by Raptor Pharmaceuticals Corp. in 2009, he served as Vice President and Chief Financial Officer of TorreyPines Therapeutics, Inc., and, from 2009 to 2010, as Vice President of a wholly-owned subsidiary of Raptor Pharmaceutical Corp. From 1994 to 2004, Mr. Johnson held various positions at MitoKor, Inc., most recently serving as Chief Financial Officer and Senior Vice President of Operations. Mr. Johnson received a B.B.A. degree in accounting from the University of Michigan-Dearborn. The Board has concluded that Mr. Johnson should serve as a director based on his experience serving as a director of biotechnology companies and his expertise in financial management.
Robert H. Rosen
Mr. Rosen has served as a director since July 2017. Since 2013, Mr. Rosen has served as President and as a director of Heron Therapeutics, Inc., and, from 2012 to 2013, served as Senior Vice President and Chief Commercial Officer of Heron Therapeutics, Inc. Since 2014, he has served as a director of La Jolla Pharmaceutical Company. From 2014 to 2015, Mr. Rosen served as a director of Conkwest, Inc. (now NantKwest, Inc.). In 2012, he served as Managing Partner of Scotia Nordic LLC, a life sciences advisory firm. From 2011 to 2012, Mr. Rosen served as Senior Vice President of Global Commercial Operations at Dendreon Corporation. From 2005 to 2011, he served as Global Head of Oncology at Bayer HealthCare Pharmaceuticals. From 2002 to 2005, Mr. Rosen was Vice President of the Oncology Business Unit at Sanofi-Synthèlabo Inc. Mr. Rosen received a B.S. degree in pharmacy from Northeastern University. The Board has concluded that Mr. Rosen should serve as a director based on his leadership experience in the biotechnology and pharmaceutical industry and expertise in commercializing pharmaceutical products.
George F. Tidmarsh, M.D., Ph.D.
Dr. Tidmarsh has served as a director since December 2016. Since 2012, Dr. Tidmarsh has served as President, Chief Executive Officer and director of La Jolla Pharmaceutical Company. In
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2005, Dr. Tidmarsh founded Horizon Pharma, Inc., where he served as President and Chief Executive Officer until 2008 and as a director and consultant until 2011. In 2001, he founded Threshold Pharmaceuticals, Inc., where he served as President until 2005. From 1996 to 2000, Dr. Tidmarsh held various senior positions at Coulter Pharmaceutical, Inc., most recently serving as Chief Medical Officer. Earlier in his career, Dr. Tidmarsh held various scientific and clinical positions at Sequus Pharmaceuticals, Inc., Gilead Sciences, Inc. and SyStemix, Inc. Dr. Tidmarsh received a Ph.D. degree and M.D. degree from the Stanford University School of Medicine and a B.S. degree in microbiology from Stanford University. The Board has concluded that Dr. Tidmarsh should serve as a director based on his experience forming, building and leading biotechnology companies.
Robert D. Millham
Mr. Millham has served as our Chief Operating Officer since July 2017. From 2015 to 2017, Mr. Millham served as Senior Vice President and General Manager, Hematology and Oncology at inVentiv Health Clinical, LLC. From 1998 to 2015, Mr. Millham held various positions at Pfizer Inc., serving most recently as Vice President of Clinical Operations for Oncology and previously as Senior Director, Early Development Team Leader. Mr. Millham received a B.A. degree in biology from Middlebury College, an M.S. degree in microbiology from the University of New Hampshire and an M.Sc. degree in pharmaceutical medicine from Hibernia College.
Joseph P. OConnell, M.D.
Dr. OConnell has served as our Chief Medical Officer since September 2017. From 2015 to 2017, Dr. OConnell served as Vice President, Medical and Scientific Affairs, Hematology and Oncology at inVentiv Health Clinical, LLC. From 2007 to 2015, Dr. OConnell held various positions at Pfizer Inc., most recently serving as Senior Director and Asset Global Clinical Lead for Oncology. Prior to 2007, he practiced adult medical oncology for more than 15 years, most recently as a Medical Oncologist at the Yale Cancer Center. Dr. OConnell received a B.S. degree in biology from Fordham University and an M.D. degree from the State University of New York.
John G. Lemkey
Mr. Lemkey has served as our Chief Financial Officer since the Companys inception in 2013. Since 2012, Mr. Lemkey has served as Chief Operating Officer of Tang Capital Management, LLC, a life sciences-focused investment company and an affiliate of the Company, which Mr. Lemkey joined in 2006. From 2003 to 2006, Mr. Lemkey was a Senior Auditor at Ernst & Young LLP. Mr. Lemkey received a B.S. degree in accounting from the University of Southern California and is a Certified Public Accountant (inactive) in the state of California.
Stewart M. Kroll
Mr. Kroll has served as our Senior Vice President of Biometrics since October 2016. From 2005 to 2016, Mr. Kroll held various positions at Threshold Pharmaceuticals, Inc., most recently serving as Chief Operating Officer. From 2000 to 2005, he served as Senior Director of Biostatistics at Corixa Corporation. From 1997 to 2000, Mr. Kroll held various positions at Coulter Pharmaceutical, Inc., most recently serving as Director of Biostatistics. Mr. Kroll received an M.A. degree and B.A. degree in statistics from the University of California, Berkeley.
Thomas Wei
Mr. Wei has served as our Senior Vice President of Research and Strategy since 2015. Mr. Wei also is Managing Director at Tang Capital Management, LLC, a life sciences-focused investment
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company and an affiliate of the Company, which he joined in 2015. From 2009 to 2015, he served as a Managing Director and biotechnology equity research analyst at Jefferies LLC. From 2003 to 2009, Mr. Wei was a biotechnology equity research analyst at Piper Jaffray, most recently serving as Managing Director. From 1998 to 2003, Mr. Wei was a biotechnology equity research analyst at Deutsche Bank AG and Adams, Harkness & Hill Inc. Mr. Wei received an A.B. degree in biochemical sciences from Harvard University and an M.B.A. degree from Oxford University.
Natasha M. Bartasch-Price
Ms. Bartasch-Price has served as our Vice President of Program Management since October 2017. From 2016 to 2017, Ms. Bartasch-Price served as Vice President, Global Project Management and Managing Director, Patient Recruitment and Retention at Bioclinica, Inc. From 2000 to 2016, Ms. Bartasch-Price held various positions at Pfizer Inc., most recently serving as Senior Director, Clinical Operations Program Lead. Ms. Bartasch-Price received a B.S. degree in biology from Shippensburg University and an M.B.A. degree from Eastern University.
Nicole H. Gollaher, J.D.
Ms. Gollaher has served as our Vice President of Legal Affairs since October 2017. From 2006 to 2017, Ms. Gollaher was self-employed in private practice representing both large and small biotechnology, pharmaceutical and medical device companies, including working on a contract basis for Pfizer Inc. From 1996 to 2004, she was an Associate at Wiggin and Dana LLP. Ms. Gollaher received a B.A. degree in international relations and history from Brown University and a J.D. from the University of Connecticut.
Valerie L. Legagneur
Ms. Legagneur has served as our Vice President of Clinical Operations since December 2016. From 2006 to 2016, Ms. Legagneur held various positions at Pfizer Inc., most recently serving as Director and Clinical Operations Program Lead for the Hematology portfolio. From 2004 to 2006, she served as Project Manager of Clinical Operations at Pharmaceutical Product Development, LLC. From 2002 to 2004, Ms. Legagneur served as a Regional Clinical Research Associate at Advanced Biologics, LLC. From 2001 to 2002, she served as a Clinical Research Assistant at Sanofi-Aventis Research. Ms. Legagneur received an M.A. degree and a B.A. degree from Stony Brook University and is an S.O.C.R.A. Certified Clinical Research Professional.
Steven S. Pfeiffer, Ph.D.
Dr. Pfeiffer has served as our Vice President of Technical Operations since August 2016. From 2015 to 2016, Dr. Pfeiffer was at Horizon Pharma PLC, most recently serving as Senior Director of Manufacturing and Development. From 2011 to 2015, he held various positions at Kythera Biopharmaceuticals, Inc., most recently serving as Associate Director of Product Research, Development and Manufacturing. From 2009 to 2010, Dr. Pfeiffer served as Associate Director at Sai Advantium Pharma Limited. From 2005 to 2009, he held various positions at Gilead Sciences, Inc., most recently serving as a Research Scientist II. Dr. Pfeiffer received a Ph.D. degree in chemistry from the University of California, Santa Barbara, an M.B.A. degree from California State University, East Bay, and a B.S. degree in chemistry from the University of Arizona.
Board Structure
Our business affairs are managed under the direction of our Board, which currently consists of 6 members. Each of our current directors will continue to serve until the election and qualification of his successor, or his earlier death, resignation or removal.
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In accordance with our certificate of incorporation and the bylaws that will become effective upon completion of the offering, our entire Board will stand for election at each annual general meeting of stockholders and will be elected to serve from the time of election and qualification until the next annual meeting following election. Each directors term continues until the election and qualification of his or her successor, or his or her earlier death, resignation or removal. Our certificate of incorporation and bylaws authorize only our Board to fill vacancies on our Board. The authorized number of directors may be changed by resolution of the Board. Any additional directorships resulting from an increase in the authorized number of directors would be filled by resolution of the Board. Kevin C. Tang, our Chief Executive Officer, serves as the Chairman of our Board.
Board Committees
Our Board has established an audit committee (Audit Committee), a compensation committee (Compensation Committee) and a nominating and corporate governance committee (Nominating and Corporate Governance Committee), each initially comprised of Craig A. Johnson and Aaron I. Davis, each of whom qualify as an independent director, as defined under applicable NASDAQ qualification standards. Additionally, Mr. Johnson qualifies as an audit committee financial expert as that term is defined in the rules and regulations established by the SEC. We believe that the functioning of these committees complies with the requirements of the Sarbanes-Oxley Act, the rules of the NASDAQ Global Select Market and SEC rules and regulations that will become applicable to us upon closing of this offering. As this is our initial public offering, we intend to comply with the requirements of the NASDAQ Global Select Market with respect to board and committee composition of independent directors as they become applicable to us in accordance with NASDAQ Marketplace Rule 5615(b)(1). Each committee has the responsibilities described below.
Audit Committee
The primary responsibilities of our Audit Committee will be to oversee the accounting and financial reporting processes and the internal and external audit processes. The Audit Committee will also assist the Board in fulfilling its oversight responsibilities by reviewing the financial information provided to stockholders and others and the system of internal controls established by management and the Board. The Audit Committee will oversee the independent auditors, including their independence and objectivity. However, committee members will not act as professional accountants or auditors, and their functions are not intended to duplicate or substitute for the activities of management and the independent auditors. The Audit Committee will be empowered to retain independent legal counsel and other advisors as it deems necessary or appropriate to assist it in fulfilling its responsibilities, and to approve the fees and other retention terms of the advisors.
Compensation Committee
The primary responsibilities of our Compensation Committee will be to periodically review and approve the compensation and other benefits for our employees, officers and independent directors. This will include reviewing and approving corporate goals and objectives relevant to the compensation of our executive officers in light of those goals and objectives, and setting compensation for these officers based on those evaluations. Our Compensation Committee will also administer and have discretionary authority over the issuance of equity awards under our equity incentive plans.
The Compensation Committee may delegate authority to review and approve the compensation of our employees to certain of our executive officers, including with respect to awards made under our equity incentive plans. Even where the Compensation Committee does not delegate authority, our executive officers will typically make recommendations to the Compensation Committee regarding compensation to be paid to our employees and the size of equity grants under our equity incentive plans.
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Nominating and Corporate Governance Committee
The Nominating and Corporate Governance Committee will be responsible for developing and recommending to the Board criteria for identifying and evaluating qualified candidates for directorships and making recommendations to the Board regarding candidates for election or reelection to the Board at each annual stockholders meeting. In addition, the Nominating and Corporate Governance Committee will be responsible for overseeing our corporate governance guidelines and reporting and making recommendations to the Board concerning corporate governance matters. The Nominating and Corporate Governance Committee will also be responsible for making recommendations to the Board concerning the structure, composition and function of the Board and its committees as well as compensation of directors for service on the Board and its committees.
Code of Conduct and Ethics
Our Board will adopt a Code of Conduct and Ethics that establishes the standards of ethical conduct applicable to all directors, officers and employees of our company. It will address, among other things, conflicts of interest, disclosure controls and procedures and internal control over financial reporting, corporate opportunities, regulatory reporting, communications and confidentiality requirements. We intend to disclose any amendments to the Code of Conduct and Ethics, or any waivers of its requirements, on our website to the extent required by applicable rules. The Audit Committee is responsible for applying and interpreting our Code of Conduct and Ethics in situations where questions are presented to it.
Compensation Committee Interlocks
Our Chairman and Chief Executive Officer, Mr. Tang, served during all of 2016 (and currently serves) as Chairman of the Board of each of La Jolla Pharmaceutical Company and Heron Therapeutics, Inc. During this same time, Dr. Tidmarsh served as President and Chief Executive Officer of La Jolla Pharmaceutical Company, and Mr. Rosen served as President of Heron Therapeutics, Inc. Notwithstanding these interlocking relationships, our independent directors do not believe that these relationships are problematic from a corporate governance perspective since Mr. Tang has elected to receive total compensation of $1.00 annually for his service as Chairman and Chief Executive Officer. To the extent any members of our Compensation Committee and affiliates of theirs have participated in transactions with us, a description of those transactions is described in Certain Relationships and Related Transactions.
Director Independence
In connection with this offering and our planned listing on NASDAQ, our Board has reviewed the independence of all directors in light of each directors (or any family members, if applicable) affiliations with the Company and members of management, as well as significant holdings of the Companys securities. The Board uses the definition of independence from The NASDAQ Stock Market listing standards to assess independence of our directors. The NASDAQ rules have objective tests and a subjective test for determining who is an independent director. The subjective test states that an independent director must be a person who lacks a relationship that, in the opinion of the Board, would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. The Board has not established categorical standards or guidelines to make these subjective determinations, but considers all relevant facts and circumstances. After considering the foregoing factors, our Board has determined that Messrs. Davis and Johnson qualify as independent directors as defined by NASDAQ rules. Mr. Tang and Dr. Vacirca are not deemed to be independent under NASDAQ rules by virtue of their current and past employment with the Company, respectively. Dr. Tidmarsh and Mr. Rosen are not deemed independent due to Mr. Tangs prior and current service on the compensation committees of La Jolla Pharmaceutical Company and Heron Therapeutics, Inc., respectively.
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Following the effectiveness of this registration statement, the members of our Audit Committee must satisfy the independence criteria set forth in Rule 10A-3 under the Exchange Act, (Rule 10A-3). In order to be considered independent for purposes of Rule 10A-3, no member of the Audit Committee may, other than in his or her capacity as a member of the Audit Committee, the Board or any other committee of the Board: (i) accept, directly or indirectly, any consulting, advisory or other compensatory fee from us or any of our subsidiaries; or (ii) directly, or indirectly through one or more intermediaries, control, be controlled by or be under common control with us or any of our subsidiaries.
Director Compensation
Commencing in 2017, we adopted a director compensation arrangement whereby we pay an annual retainer of $50,000 per year to each non-employee director, with an additional $25,000 annual fee for service as the vice chairman of the Board, $15,000 annual fee for service as chairperson of the Audit Committee and $10,000 annual fee for service as chairperson of the Compensation Committee. Such cash fees are paid quarterly in arrears. We also may make periodic equity grants to such directors, but have no current commitments to do so. We reimburse our directors for their reasonable out-of-pocket expenses incurred in attending board and committee meetings. Mr. Davis has waived all compensation for his services on the Board.
The following table shows the compensation earned in 2016 by the directors who served on the Board in that year.
Name |
Fees Earned or
Paid in Cash in 2016 |
Incentive Unit
Awards (1) |
Total | |||||||||
Kevin C. Tang |
$ | - | $ | - | $ | - | ||||||
Aaron I. Davis |
$ | - | $ | - | $ | - | ||||||
George F. Tidmarsh, M.D., Ph.D. |
$ | - | $ | 26,521 | $ | 26,521 |
(1) | The amounts reported in this column represent the grant-date fair value of the 122,046 incentive units granted by Odonate Management Holdings, LLC to Dr. Tidmarsh during 2016, as computed in accordance with ASC Topic 718, not including any estimates of forfeitures. The assumptions used in calculating the grant-date fair value of the incentive units reported in this column are set forth in the notes to our financial statements included herein. Note that the amounts reported in this column reflect the accounting cost for this equity award and may not correspond to the actual economic value that may be received by Dr. Tidmarsh. |
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In 2016, we had two executive officers: Kevin C. Tang, our Chairman and Chief Executive Officer, and John G. Lemkey, our Chief Financial Officer.
Summary Compensation Table
The following table summarizes information concerning the compensation awarded to, earned by or paid to Mr. Tang, our sole Named Executive Officer (NEO) in 2016.
Name and Principal Position |
Year | Salary |
Incentive
unit awards |
Non-equity
incentive plan compensation |
All other
compensation |
Total | ||||||||||||||||||
Kevin C. Tang |
2016 | $1.00 | $ - | $ - | $ - | $1.00 | ||||||||||||||||||
Chairman and Chief Executive Officer |
Chief Executive Officer Compensation
Mr. Tang has elected to receive an annual salary of $1.00 and to not receive any bonuses, equity awards or other compensation. Accordingly, there were no equity awards held by Mr. Tang as of the last day of fiscal year 2016.
Equity Compensation Plans
We have historically maintained an equity incentive plan, the Odonate Management Holdings Equity Incentive Plan (the Management Plan), which provides for the grant of profits interests in the form of incentive units to eligible employees, officers, directors and consultants. There is no specified reserve for the number of incentive units to be issued under the Management Plan. We intend to adopt a Stock Option Plan and an Employee Stock Purchase Plan for use following the completion of this offering, at which time we will stop granting incentive units under the Management Plan. A description of the Management Plan is set forth above under the heading Managements Discussion and Analysis of Financial Condition and Results of Operations and is incorporated herein by reference. Descriptions of the 2017 Stock Option Plan and 2017 Employee Stock Purchase Plan are set forth below.
2017 Stock Option Plan
Prior to completion of this offering, we will adopt the Odonate Therapeutics, Inc. 2017 Stock Option Plan, which we refer to as the 2017 Plan. The purpose of the 2017 Plan is to promote and closely align the interests of our employees, officers, directors and consultants with those of our stockholders by providing stock-based compensation in the form of stock options. The objectives of the 2017 Plan are to attract and retain the best available personnel and to motivate participants to optimize the success of the Company through incentives that link the personal interests of participants to those of the Companys stockholders.
The following description of the 2017 Plan is not intended to be complete and is qualified in its entirety by the complete text of the 2017 Plan, a copy of which will be filed as an exhibit to the registration statement of which this prospectus forms a part. Stockholders and potential investors are urged to read the 2017 Plan in its entirety. Any capitalized terms that are used in this summary description but not defined here or elsewhere in this registration statement have the meanings assigned to them in the 2017 Plan.
Administration
The 2017 Plan will be administered by our Compensation Committee, or such other committee designated by our Board, to administer the plan. The Compensation Committee will have broad
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authority, subject to the provisions of the 2017 Plan, to administer and interpret the 2017 Plan. All decisions and actions of the Compensation Committee will be final.
Eligibility
Stock options may be granted to employees, officers, directors and consultants of the Company.
Stock Subject to 2017 Plan
The maximum number of shares that may be issued under the 2017 Plan will not exceed 4,800,000, subject to certain adjustments in the event of a change in the Companys capitalization. Shares of common stock issued under the 2017 Plan may be either authorized and unissued shares or previously issued shares acquired by the Company. On termination or expiration of an unexercised option under the 2017 Plan, in whole or in part, the number of shares of common stock subject to such award will again become available for grant under the 2017 Plan.
Stock Options
All stock options granted under the 2017 Plan will be evidenced by a written agreement with the participant, which provides, among other things, whether the option is intended to be an incentive stock option or a non-qualified stock option, the number of shares subject to the option, the exercise price, exercisability (or vesting) and the term of the option, which may not generally exceed 10 years. Subject to the express provisions of the 2017 Plan, options generally may be exercised over such period, in installments or otherwise, as the Compensation Committee may determine. The exercise price for any stock option granted may not generally be less than the fair market value of the common stock on the grant date. The exercise price may be paid in cash or such other method as determined by the Compensation Committee. Other than in connection with a change in the Companys capitalization, we will not, without stockholder approval, reduce the exercise price of a previously awarded option, and, at any time when the exercise price of a previously awarded option is above the fair market value of a share of common stock, we will not, without stockholder approval, cancel and re-grant or exchange such option for cash or a new award with a lower (or no) exercise price.
Performance Criteria
The Compensation Committee may specify certain performance criteria that must be satisfied before stock options will be granted or vest. The performance goals may vary from participant to participant, group to group and period to period.
Transferability
Options generally may not be sold, transferred for value, pledged, assigned or otherwise alienated or hypothecated by a participant other than by will or the laws of descent and distribution, and each option may be exercisable only by the participant during his or her lifetime.
Amendment and Termination
The Board has the right to amend, alter, suspend or terminate the 2017 Plan at any time, provided certain material amendments may not be made without stockholder approval. No amendment or alteration to the 2017 Plan or an award or award agreement will be made that would materially impair the rights of the holder, without such holders consent; however, no consent will be required if the Compensation Committee determines in its sole discretion and prior to the date of any change in control, that such amendment or alteration either is required or advisable in order for us, the 2017 Plan
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or the award: to satisfy any law or regulation or to meet the requirements of or avoid adverse financial accounting consequences under any accounting standard or if the change does not significantly diminish the benefits provided under such award. The 2017 Plan will be adopted by the Board and the Companys stockholders in connection with this offering and will automatically terminate, unless earlier terminated by the Board, 10 years after approval by the Board.
2017 Employee Stock Purchase Plan
Prior to the completion of this offering, we will adopt the Odonate Therapeutics, Inc. 2017 Employee Stock Purchase Plan, which we refer to as the ESPP. The purpose of the ESPP is to provide a means for our eligible employees to accumulate shares of our common stock over time through regular payroll deductions. A total of 500,000 shares of our common stock will initially be available for issuance under the ESPP. Under the ESPP, eligible employees of the Company may purchase shares of our common stock once every 6 months at a price equal to the lesser of 85% of the fair market value of a share of our common stock at the beginning of the purchase period or 85% of the fair market value of a share of our common stock at the end of the 6-month purchase period. Eligible employees purchasing shares under the ESPP will be subject to an annual cap equal to the lesser of $25,000 or 10% of the employees annual cash compensation. Shares purchased under the ESPP cannot be sold for a period of one year following the purchase date (or such shorter period of time if the participating employees employment terminates before this one-year anniversary). As of the date of this prospectus, our Board has not determined the date on which the initial purchase period will commence under the ESPP; however, the initial purchase period will not commence prior to the completion of this offering.
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The following table presents information regarding beneficial ownership of our equity interests as of November 27, 2017 by:
| each stockholder or group of stockholders known by us to be the beneficial owner of more than 1% of our outstanding equity interests (our Principal Investors); |
| each of our directors; |
| our NEO; and |
| all of our directors and executive officers as a group. |
The percentage ownership information shown in the column titled Percentage of Units/Shares Beneficially Owned Before the Offering in the table below is based on 20,640,356 units (17,708,954 common units and 2,931,402 incentive units) outstanding as of November 27, 2017, after giving effect to the 2-for-1 forward split, which became effective on November 26, 2017. The percentage ownership information shown in the column titled Percentage of Units/Shares Beneficially Owned After the Offering in the table below is based on 26,520,356 shares of common stock outstanding after this offering, assuming 5,880,000 common shares being sold in the offering.
Existing stockholders affiliated with our directors have indicated an interest in purchasing approximately $25.0 million of shares of our common stock in this offering at the initial public offering price of $25.50, which is the midpoint of the range set forth on the cover of this prospectus. The information set forth below does not reflect any potential purchases in this offering by such existing stockholders.
Beneficial ownership is determined in accordance with the rules of the SEC, and thus represents voting or investment power with respect to our securities as of November 27, 2017. Unless otherwise indicated below, to our knowledge, the persons and entities named in the table have sole voting and sole investment power with respect to all equity interests beneficially owned, subject to community property laws where applicable. Unless otherwise indicated, the address of each individual listed in this table is 4747 Executive Drive, Suite 510, San Diego, CA 92121.
Units/Shares
Beneficially Owned |
Percentage of Units/Shares Beneficially Owned |
|||||||||||
Name and Address of Beneficial Owner |
Before the Offering | After the Offering | ||||||||||
Principal Investors (1) |
||||||||||||
Affiliates of Tang Capital Partners (2) |
10,910,672 | 52.9 | % | 41.1 | % | |||||||
Affiliates of Boxer Capital (3) |
2,956,028 | 14.3 | % | 11.1 | % | |||||||
Odonate Holdings, LLC (4) |
2,931,402 | 14.2 | % | 11.1 | % | |||||||
Affiliates of Janus Capital Management (5) |
872,778 | 4.2 | % | 3.3 | % | |||||||
Affiliates of Sabby Management (6) |
718,247 | 3.5 | % | 2.7 | % | |||||||
Funds managed by Franklin Advisers, Inc. (7) |
537,094 | 2.6 | % | 2.0 | % | |||||||
Solus LLC (8) |
471,616 | 2.3 | % | 1.8 | % | |||||||
Affiliates of Arcus Ventures Funds (9) |
302,837 | 1.5 | % | 1.1 | % | |||||||
Rock Springs Capital Master Fund, LP (10) |
268,548 | 1.3 | % | 1.0 | % | |||||||
Affiliates of RTW Investments (11) |
268,548 | 1.3 | % | 1.0 | % | |||||||
Samsara BioCapital, LP (12) |
268,548 | 1.3 | % | 1.0 | % | |||||||
Named Executive Officer and Directors |
||||||||||||
Kevin C. Tang (2) |
10,910,672 | 52.9 | % | 41.1 | % | |||||||
Aaron I. Davis (3) |
645,756 | 3.1 | % | 2.4 | % | |||||||
Jeff L. Vacirca, M.D. (4) |
229,647 | 1.1 | % | * | ||||||||
George F. Tidmarsh, M.D., Ph.D. (4) |
30,512 | * | * | |||||||||
Craig A. Johnson (4) |
- | * | * | |||||||||
Robert H. Rosen (4) |
- | * | * | |||||||||
All Executive Officers and Directors as a group (9 persons) |
11,816,587 | 57.2 | % | 44.5 | % |
* | Indicates ownership of less than one percent. |
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(1) | This represents the beneficial ownership as of November 27, 2017, which gives effect to the distribution by Odonate Holdings, LLC to each of its common unitholders immediately following this offering. Securities that a person has the right to acquire within 60 days of November 27, 2017 are included in such persons beneficial ownership. |
(2) | Affiliates of Tang Capital Partners include Tang Capital Partners II, LP (TCPII) and TCPIL BL, LLC (TCPIL), which share voting and dispositive power over such common units with Tang Capital Management II, LLC (TCMII) and Kevin C. Tang, who is the manager of TCMII. TCPII is the beneficial owner of 6,229,728 common units, and TCPIL is the beneficial owner of 4,680,944 common units. The common units beneficially owned by Mr. Tang include the common units beneficially owned by TCPII and TCPIL for which Mr. Tang shares voting and/or dispositive power. Mr. Tang disclaims beneficial ownership of all common units reported herein except to the extent of his pecuniary interest therein. Mr. Tang is the Chairman and Chief Executive Officer of the Company. The address of the foregoing entities is 4747 Executive Drive, Suite 510, San Diego, CA 92121. |
(3) | Affiliates of Boxer Capital consist of Boxer Capital, LLC (Boxer Capital), which is the beneficial owner of 2,310,272 common units, and Aaron I. Davis, who is the Chief Executive Officer of Boxer Capital and a director of the Company, is the beneficial owner of 645,756 common units. Boxer Asset Management Inc. (Boxer Management) is the majority owner of Boxer Capital. Joe Lewis, a natural person, is the sole indirect beneficial owner of and controls Boxer Management. Mr. Davis is not deemed to be the beneficial owner of the common units held by Boxer Capital. The address for the Affiliates of Boxer Capital is 11682 El Camino Real, Suite 320, San Diego, CA 92130. |
(4) | Following the Conversion, Odonate Holdings, LLC (Odonate Holdings) will retain record title to a total of 2,931,402 shares of common stock, which represents the total number of shares underlying incentive units previously granted to certain employees, officers, directors and consultants through the Odonate Therapeutics, LLC Employee Equity Incentive Plan. Concurrent with the Conversion, Odonate Holdings will give to the Company an irrevocable proxy directing the Company to vote all shares of common stock held by Odonate Holdings, with such vote to be cast in the same proportion as the vote by all other stockholders of the Company. Accordingly, Odonate Holdings does not have any voting control of any shares that it may own. The address of Odonate Holdings is 4747 Executive Drive, Suite 510, San Diego, CA 92121. |
(5) | Affiliates of Janus Capital Management include Janus Capital Management, LLC (Janus Capital), Janus Henderson Global Life Sciences Fund (Janus Henderson) and JCFJanus Global Life Sciences Fund (Janus Global), which share voting and dispositive power with respect to 872,778 common units. Janus Henderson is the beneficial owner of 573,540 common units. Janus Global is the beneficial owner of 299,238 common units. As a result of its role as investment adviser or sub-adviser of Janus Henderson and Janus Global, Janus Capital may be deemed to be the beneficial owner of common units held by Janus Henderson and Janus Global. Janus Capital does not have the right to receive any dividends from, or the proceeds from the sale of, the securities held in Janus Henderson and Janus Global and disclaims any ownership associated with such rights. The address of the foregoing entities is 151 Detroit Street, Denver, CO 80206. |
(6) | Affiliates of Sabby Management include Sabby Healthcare Master Fund, Ltd. (Sabby Healthcare), Sabby Volatility Warrant Master Fund Ltd. (Sabby Volatility), Hal Mintz, Robert Grundstein and John Kwon. Sabby Healthcare is the beneficial owner of 325,554 common units. Sabby Volatility is the beneficial owner of 33,568 common units. Hal Mintz is the beneficial owner of 300,628 common units. Robert Grundstein is the beneficial owner of 50,105 common units. John Kwon is the beneficial owner of 8,392 common units. Mr. Mintz has voting and investment power over the shares held by Sabby Healthcare and Sabby Volatility. Sabby Management, LLC serves as the investment manager of Sabby Healthcare and Sabby Volatility and Mr. Mintz is the manager of Sabby Management, LLC. Each of Sabby Management, LLC and Mr. Mintz disclaims beneficial ownership over these shares except to the extent of any pecuniary interest therein. The address of each of Sabby Healthcare and Sabby Volatility is c/o Ogier Fiduciary Services (Cayman) Limited, 89 Nexus Way, Camana Bay, Grand Cayman KY1-9007, Cayman Islands. |
(7) | Funds managed by Franklin Advisers, Inc. (FAV) include Franklin Strategic SeriesFranklin Biotechnology Discovery Fund (Franklin Strategic) and Franklin Templeton Investment FundsFranklin Biotechnology Discovery Fund (Franklin Investment). Franklin Strategic has beneficial ownership of 187,982 common units, and Franklin Investment has beneficial ownership of 349,112 common units. FAV is the investment manager for each of the funds and accounts that are the registered holders of these securities. FAV is an indirect wholly owned subsidiary of a publicly traded company, Franklin Resources, Inc. (FRI) and may be deemed to be the beneficial owner of these securities for purposes of Rule 13d-3 under the Exchange Act in its capacity as the investment adviser to such funds and accounts pursuant to investment management contracts that grant investment and/or voting power to FAV. When an investment management contract (including a sub-advisory agreement) delegates to FAV investment discretion or voting power over the securities held in the investment advisory accounts that are subject to that agreement, FRI treats FAV as having sole investment discretion or voting authority, as the case may be, unless the agreement specifies otherwise. Accordingly, FAV reports for purposes of Section 13(d) of the Exchange Act that it has sole investment discretion and voting authority over the securities covered by any such investment management agreement, unless otherwise specifically noted. The principal address of the foregoing entities is One Franklin Parkway, San Mateo, CA 94403. |
(8) | Solus LLC is the beneficial owner of 471,616 common units. Solus Alternative Asset Management LP, the investment advisor of Solus LLC, has voting authority with respect to the common units owned by Solus LLC. The address of both Solus LLC and Solus Alternative Asset Management LP is 410 Park Avenue, 11 th Floor, New York, NY 10022. |
(9) | Affiliates of Arcus Ventures Funds include Arcus Ventures Fund II, LP (Arcus II) and Arcus Ventures Fund, LP (Arcus Ventures). Arcus II is the beneficial owner of 276,752 common units. Arcus Ventures is the beneficial owner of 26,085 common units. The address of the foregoing entities is 60 E 42 nd Street, Suite 1610, New York, NY 10165. |
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(10) | Rock Springs Capital Master Fund LP is the beneficial owner of 268,548 common units. Rock Springs Capital Master Fund LP and its general partner, Rock Springs Capital General Partner LLC, each have sole voting and investment power, and Kris Jenner, Gordon Margraf Bussard and Graham McPhail, the managers of Rock Springs Capital General Partner LLC, each have shared voting and investment power with regard to the shares owned by Rock Springs Capital Master Fund LP. The address of Rock Springs Capital Master Fund LP is c/o Walkers Corporate Limited, Cayman Corporate Centre, 27 Hospital Road, George Town, Grand Cayman KY1-9008, Cayman Islands. The address of Rock Springs General Partner LLC is 650 South Exeter, Suite 1070, Baltimore, MD 21202. |
(11) | Affiliates of RTW Investments include RTW Master Fund, Ltd., RTW Innovation Master Fund, Ltd. and RTW Investments, LP. RTW Master Fund, Ltd. is the beneficial owner of 258,188 common units. RTW Innovation Master Fund, Ltd. is the beneficial owner of 10,360 common units. RTW Master Fund, Ltd. and RTW Innovation Master Fund, Ltd. are managed by RTW Investments, LP (the Adviser). The Adviser, in its capacity as the investment manager of such, has the power to vote and the power to direct the disposition of all shares held by such funds. Accordingly, the Adviser and Roderick Wong, as the Managing Partner of the Adviser, may be deemed to beneficially own all such shares. The address of the foregoing entities is 250 West 55th Street, 16th Floor, Suite A, New York, NY 10019. |
(12) | Samsara BioCapital, L.P. (the Fund) is the beneficial owner of 268,548 common units. Samsara BioCapital GP, LLC (the General Partner) is the general partner of the Fund. The managing members of the General Partner are Srinivas Akkaraju, M.D., Ph.D., and Michael Dybbs. These individuals may be deemed to have shared voting and investment power of the securities held by the Fund. The address of the foregoing entities is 565 Everett Avenue, Palo Alto, CA 94301. |
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CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
The following is a summary of each transaction or series of similar transactions since January 1, 2014, or any currently proposed transaction, to which we were or are a party in which:
| the amount involved exceeded or exceeds $120,000; and |
| any of our directors or executive officers, any holder of 5% of any class of our voting capital stock or any member of his or her immediate family had or will have a direct or indirect material interest. |
Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to such securities.
Related Party Transaction Policy
Prior to this offering, we did not have a formal policy regarding approval of transactions with related parties. We will adopt a related party transaction policy that sets forth our procedures for the identification, review, consideration and approval or ratification of related person transactions. The policy will become effective upon the execution of the underwriting agreement for this offering. For purposes of our policy only, a related person transaction is a transaction, arrangement or relationship, or any series of similar transactions, arrangements or relationships, in which we and any related person are, were or will be participants in which the amount involved exceeds $120,000. Transactions involving compensation for services provided to us as an employee or director are not covered by this policy. A related person is any executive officer, director or beneficial owner of more than 5% of any class of our voting securities, including any of their immediate family members and any entity owned or controlled by such persons.
Under the policy, if a transaction has been identified as a related party transaction, including any transaction that was not a related party transaction when originally consummated or any transaction that was not initially identified as a related party transaction prior to consummation, our management must present information regarding the related party transaction to our Audit Committee, or, if Audit Committee approval would be inappropriate, to another independent body of our Board, for review, consideration and approval or ratification. The presentation must include a description of, among other things, the material facts, the interests, direct and indirect, of the related persons, the benefits to us of the transaction and whether the transaction is on terms that are comparable to the terms available to or from, as the case may be, an unrelated third party or to or from employees generally. Under the policy, we will collect information that we deem reasonably necessary from each director, executive officer and, to the extent feasible, significant stockholder to enable us to identify any existing or potential related party transactions and to effectuate the terms of the policy. In addition, under our Code of Business Conduct and Ethics, our employees and directors have an affirmative responsibility to disclose any transaction or relationship that reasonably could be expected to give rise to a conflict of interest. In considering related party transactions, our Audit Committee, or other independent body of our Board, will take into account the relevant available facts and circumstances including, but not limited to:
| the risks, costs and benefits to us; |
| the impact on a directors independence in the event that the related person is a director, immediate family member of a director or an entity with which a director is affiliated; |
| the availability of other sources for comparable services or products; and |
| the terms available to or from, as the case may be, unrelated third parties or to or from employees generally. |
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The policy requires that, in determining whether to approve, ratify or reject a related party transaction, our Audit Committee, or other independent body of our Board, must consider, in light of known circumstances, whether the transaction is in, or is not inconsistent with, our best interests and those of our stockholders, as our Audit Committee, or other independent body of our Board, determines in the good faith exercise of its discretion.
The transactions described below were consummated prior to our adoption of the formal, written policy described above, and, accordingly, the foregoing policies and procedures were not followed with respect to these transactions. However, we believe that the terms obtained or consideration that we paid or received, as applicable, in connection with the transactions described below were comparable to terms available or the amounts that would be paid or received, as applicable, in arms-length transactions at such time.
Related Party Transactions
The following table sets forth a summary of the sale of our securities to related persons since January 1, 2014. For a description of beneficial ownership, see Principal Stockholders.
Purchaser |
Common
Units |
Total Purchase
Price |
||||||
Affiliates of Tang Capital Partners (1) |
10,425,562 | $ | 41,021,317 | |||||
Boxer Capital, LLC (2) |
2,133,760 | $ | 9,707,597 | |||||
Aaron I. Davis (2) |
645,756 | $ | 350,000 |
(1) | Affiliates of Tang Capital Partners include Tang Capital Partners II, LP (TCPII) and TCPIL BL, LLC (TCPIL), which share voting and dispositive power over such common units with Tang Capital Management II, LLC (TCMII) and Kevin C. Tang, who is the manager of TCMII. TCPII is the beneficial owner of 6,229,728 common units, and TCPIL is the beneficial owner of 4,680,944 common units. The common units beneficially owned by Mr. Tang include the common units beneficially owned by TCPII and TCPIL for which Mr. Tang shares voting and/or dispositive power. Mr. Tang disclaims beneficial ownership of all common units reported herein except to the extent of his pecuniary interest therein. Mr. Tang is the Chairman and Chief Executive Officer of the Company. |
(2) | Aaron I. Davis is the Chief Executive Officer of Boxer Capital, LLC (Boxer Capital) and is also a director of the Company. Boxer Asset Management Inc. (Boxer Management) is the majority owner of Boxer Capital. Joe Lewis, a natural person, is the sole indirect beneficial owner of and controls Boxer Management. Mr. Davis is not deemed to be the beneficial owner of the common units held by Boxer Capital. |
Prior to the Conversion, we had two classes of membership units authorized: common units and incentive units. On August 14, 2016, we effected a 1-for-50 reverse split of the outstanding common and incentive units. On November 26, 2017, we effected a 2-for-1 forward split of the outstanding common and incentive units. The units and per-unit figures presented herein have been adjusted and are presented to reflect these splits.
In June 2016, we raised $5.0 million through the sale of 9,283,762 common units at a price of $0.54 per unit (the June 2016 Financing). In the June 2016 Financing, we sold a total of 6,461,794 common units to entities affiliated with Tang Capital Partners, LP, which is beneficially owned by Kevin C. Tang, our Chairman and Chief Executive Officer, and a total of 1,118,986 common units to Boxer Capital, LLC and 645,756 common units directly to Aaron I. Davis. Mr. Davis is the Chief Executive Officer of Boxer Capital, LLC and is also a director of the Company.
In March 2017, we raised $10.0 million through the sale of 2,593,024 common units at a price of $3.86 per common unit (the March 2017 Financing). This offering was made pro rata to all of our members that participated in the June 2016 Financing. In the March 2017 Financing, we sold a total of 1,949,658 common units to entities affiliated with Tang Capital Partners, LP, which is beneficially owned by Kevin C. Tang, our Chairman and Chief Executive Officer, and 544,816 common units to Boxer Capital, LLC. Mr. Davis is the Chief Executive Officer of Boxer Capital, LLC and is also a director of the Company.
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In September 2017, we raised $74.0 million through the sale of 4,968,132 common units at a price of $14.90 per common unit (the September 2017 Financing). In the September 2017 Financing, we sold a total of 2,014,110 common units to entities affiliated with Tang Capital Partners, LP, which is beneficially owned by Kevin C. Tang, our Chairman and Chief Executive Officer, and 469,958 common units to Boxer Capital, LLC. Mr. Davis is the Chief Executive Officer of Boxer Capital, LLC and is also a director of the Company.
In 2016, for his services as an employee, our Vice Chairman was paid cash compensation of $280,000 and received incentive units valued at $144,000. The incentive units issued to our Vice Chairman were subject to a risk of forfeiture and vest over a 4-year period.
Commencing in 2016, the Company received certain services and other benefits from an affiliate of our Chairman and Chief Executive Officer. The Company was not charged any fees for these services and other benefits, which included personnel costs for research and development and administrative functions, rent and facility costs and other direct expenses. From January 1, 2016 through September 30, 2017, a total of $2.7 million of services and other benefits was provided without charge to the Company, which amount was recorded as a non-cash expense with a corresponding increase to non-cash contributed capital. See Note 7 in the Notes to Financial Statements contained herein.
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General
The following is a summary of the material terms of our capital stock, as well as other material terms of our certificate of incorporation and bylaws, as each will be in effect prior to the closing of this offering, and certain provisions of Delaware law. This summary does not purport to be complete and is qualified in its entirety by the provisions of our certificate of incorporation and bylaws, copies of which will be filed with the SEC as exhibits to the registration statement, of which this prospectus forms a part. References in this section to the company, we, us and our refer to Odonate Therapeutics, Inc.
Upon the consummation of this offering, our authorized capital stock will consist of 100,000,000 shares of common stock, $0.01 par value per share. We will not have any class or series of preferred stock authorized, nor will we have blank check preferred stock authorized.
Common Stock
Our certificate of incorporation will authorize the issuance of up to 100,000,000 shares of common stock. All outstanding shares of common stock are validly issued, fully paid and nonassessable, and the shares of common stock to be issued in connection with this offering will be validly issued, fully paid and nonassessable.
The holders of our common stock will be entitled to one vote per share on all matters submitted to a vote of stockholders, and our certificate of incorporation will not provide for cumulative voting in the election of directors. The holders of our common stock will receive ratably any dividends declared by our Board out of funds legally available therefor. In the event of our liquidation, dissolution or winding-up, the holders of our common stock will be entitled to share ratably in all assets remaining after payment of or provision for any liabilities.
Our Certificate of Incorporation and Our Bylaws
Special Meetings; Action by Written Consent
Under our certificate of incorporation, stockholders beneficially owning 10% or more of the outstanding common stock, individually or collectively as a group, will be able to call special meetings of stockholders, subject to complying with the applicable procedures set forth in our bylaws. Under Delaware law, stockholders of Odonate will be permitted to take action by written consent with respect to any matter that can be acted upon at a meeting of our stockholders.
Requirements for Advance Notification of Stockholder Nominations and Proposals
Our bylaws establish advance notice procedures with respect to stockholder proposals and the nomination of candidates for election as directors.
Election and Removal of Directors
Directors will be elected by a plurality vote. The Board will have the right to increase or decrease the size of the Board and to fill vacancies on the Board. Directors may be removed with or without cause with the approval of the holders of a majority of our outstanding common stock.
Delaware General Corporation Law Section 203
We have expressly elected not to be governed by the provisions of Section 203 of the Delaware General Corporation Law, which is a Delaware statute that (if applicable) may serve to prevent or deter an unsolicited takeover of the Company.
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Transfer Agent and Registrar
American Stock Transfer & Trust Company, LLC will serve as the transfer agent and registrar for our common stock.
Listing
We have applied to list our common stock on the NASDAQ Global Select Market under the symbol ODT.
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SHARES ELIGIBLE FOR FUTURE SALE
Prior to this offering, there has been no public market for our units. Future sales of our common stock, including shares issued upon the exercise of options or warrants, in the public market after this offering, or the perception that those sales may occur, could cause the prevailing market price for our common stock to fall or impair our ability to raise equity capital in the future. As described below, only a limited number of shares of our common stock will be available for sale in the public market for a period of several months after consummation of this offering due to contractual and legal restrictions on resale described below. Future sales of our common stock in the public market either before (to the extent permitted) or after restrictions lapse, or the perception that those sales may occur, could adversely affect the prevailing market price of our common stock at such time and our ability to raise equity capital at a time and price we deem appropriate.
Sale of Restricted Shares
Immediately following the consummation of this offering, we will have an aggregate of 26,520,356 shares of common stock outstanding. Of the outstanding shares of our common stock, the 5,880,000 shares sold in this offering (or 6,762,000 shares if the underwriters exercise in full their option to purchase additional shares) will be freely tradable without restriction or further registration under the Securities Act, except that any shares held by our affiliates, as that term is defined in Rule 144 of the Securities Act, may generally be sold only in compliance with the limitations described below. All remaining shares of equity securities held by existing stockholders immediately prior to the closing of this offering will be restricted securities as such term is defined in Rule 144. These restricted securities were issued and sold by us, or will be issued and sold by us, in private transactions and are eligible for public sale only if registered under the Securities Act or if they qualify for an exemption from registration under the Securities Act, including the exemptions provided by Rule 144 or Rule 701, which rules are summarized below.
Lock-Up Agreements
We and all of our directors and officers, as well as the other holders of substantially all shares of our common stock outstanding immediately prior to the completion of this offering, have agreed with the underwriters that, for a period of 180 days following the date of this prospectus, subject to certain exceptions, we and they will not, directly or indirectly, offer, sell, contract to sell, pledge, grant any option to purchase, make any short sale or otherwise dispose of any of our membership interests or shares of common stock, or any options or warrants to purchase any shares of our membership interests or common stock, or any securities convertible into, or exchangeable for or that represent the right to receive shares of our membership interests or common stock. Goldman Sachs & Co. LLC and Jefferies LLC may, in their sole discretion, release all or any portion of the shares from these restrictions.
Rule 144
In general, under Rule 144, as currently in effect, once we have been subject to the public company reporting requirements of the Exchange Act for at least 90 days, a person (or persons whose shares are required to be aggregated) who is not deemed to have been one of our affiliates for purposes of Rule 144 at any time during the three months preceding a sale, and who has beneficially owned restricted securities within the meaning of Rule 144 for at least 6 months, including the holding period of any prior owner other than one of our affiliates, is entitled to sell those shares in the public market (subject to the lock-up agreement referred to above, if applicable) without complying with the manner of sale, volume limitations or notice provisions of Rule 144, but subject to compliance with the public information requirements of Rule 144. If such a person has beneficially owned the shares
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proposed to be sold for at least one year, including the holding period of any prior owner other than affiliates, then such person is entitled to sell such shares in the public market without complying with any of the requirements of Rule 144 (subject to the lock-up agreement referred to above, if applicable). In general, under Rule 144, as currently in effect, once we have been subject to the public company reporting requirements of the Exchange Act for at least 90 days, our affiliates, as defined in Rule 144, who have beneficially owned the shares proposed to be sold for at least 6 months are entitled to sell in the public market, upon expiration of any applicable lock-up agreements and within any three-month period, a number of those shares of our equity interests that does not exceed the greater of:
| one percent of the number of equity interests then outstanding, which will equal approximately 265,204 shares of common stock immediately after this offering (calculated on the basis of the assumptions described above and assuming no exercise of the underwriters option to purchase additional shares of common stock); or |
| the average weekly trading volume of our common stock on the NASDAQ Global Select Market during the 4 calendar weeks preceding the filing of a notice on Form 144 with respect to such sale. |
Such sales under Rule 144 by our affiliates or persons selling shares on behalf of our affiliates are also subject to certain manner of sale provisions, notice requirements and to the availability of current public information about us. Notwithstanding the availability of Rule 144, the holders of substantially all of our restricted securities have entered into lock-up agreements as referenced above and their restricted securities will become eligible for sale (subject to the above limitations under Rule 144) upon the expiration of the restrictions set forth in those agreements.
Rule 701
In general, under Rule 701 as currently in effect, any of our employees, directors, officers, consultants or advisors who acquired common stock from us in connection with a written compensatory stock or option plan or other written agreement in compliance with Rule 701 under the Securities Act before the effective date of the registration statement of which this prospectus is a part (to the extent such common stock is not subject to a lock-up agreement) is entitled to rely on Rule 701 to resell such shares beginning 90 days after we become subject to the public company reporting requirements of the Exchange Act in reliance on Rule 144, but without compliance with the holding period requirements contained in Rule 144. Accordingly, subject to any applicable lock-up agreements, beginning 90 days after we become subject to the public company reporting requirements of the Exchange Act, under Rule 701, persons who are not our affiliates, as defined in Rule 144 may resell those shares without complying with the minimum holding period or public information requirements of Rule 144, and persons who are our affiliates may resell those shares without compliance with Rule 144s minimum holding period requirements (subject to the terms of the lock-up agreements referred to above, if applicable).
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MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS
The following discussion is a summary of material U.S. federal income tax consequences to Non-U.S. Holders (as defined below) of the purchase, ownership and disposition of our common stock issued pursuant to this offering. The discussion does not purport to be a complete analysis of all potential tax consequences. The consequences of other U.S. federal tax laws, such as estate and gift tax laws, and any applicable state, local or non-U.S. tax laws, are not discussed. This discussion is based on the U.S. Internal Revenue Code of 1986, as amended (the Code), Treasury Regulations promulgated under the Code, judicial decisions and published rulings and administrative pronouncements of the U.S. Internal Revenue Service (IRS), in each case in effect as of the date hereof. These authorities may change or be subject to differing interpretations. Any such change or differing interpretation may be applied retroactively in a manner that could adversely affect a Non-U.S. Holder of our common stock. We have not sought and will not seek any rulings from the IRS regarding the matters discussed below. There can be no assurance the IRS or a court will not take a contrary position to that discussed below regarding the tax consequences of the purchase, ownership and disposition of our common stock.
This discussion is limited to Non-U.S. Holders that hold our common stock as a capital asset within the meaning of Section 1221 of the Code (generally, property held for investment). This discussion does not address all U.S. federal income tax consequences relevant to a Non-U.S. Holders particular circumstances, including without limitation the impact of the Medicare contribution tax on net investment income. In addition, it does not address consequences relevant to Non-U.S. Holders subject to special rules, including, without limitation:
| U.S. expatriates and former citizens or long-term residents of the U.S.; |
| persons subject to the alternative minimum tax; |
| persons holding our common stock as part of a hedge, straddle or other risk-reduction strategy or as part of a conversion transaction or other integrated investment; |
| banks, insurance companies and other financial institutions; |
| brokers, dealers or traders in securities; |
| controlled foreign corporations, passive foreign investment companies and corporations that accumulate earnings to avoid U.S. federal income tax; |
| partnerships or other entities or arrangements classified as partnerships for U.S. federal income tax purposes (and investors therein); |
| tax-exempt organizations or governmental organizations; |
| persons deemed to sell our common stock under the constructive sale provisions of the Code; |
| persons who hold or receive our common stock pursuant to the exercise of any employee stock option or otherwise as compensation; |
| holders of Odonate Therapeutics, LLC membership units that are converted into Odonate Therapeutics, Inc. common stock as a result of the Conversion; and |
| tax-qualified retirement plans. |
If an entity or arrangement classified as a partnership for U.S. federal income tax purposes holds our common stock, the tax treatment of a partner in the partnership will depend on the status of the partner, the activities of the partnership and certain determinations made at the partner level. Accordingly, partnerships holding our common stock and the partners in such partnerships should consult their tax advisors regarding the U.S. federal income tax consequences to them.
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This discussion is for informational purposes only and is not tax advice. Investors should consult their tax advisors with respect to the application of the U.S. federal income tax laws to their particular situations as well as any tax consequences of the purchase, ownership and disposition of our common stock arising under the U.S. Federal estate or gift tax laws or under the laws of any state, local or non-U.S. Taxing jurisdiction or under any applicable income tax treaty.
Definition of a Non-U.S. Holder
For purposes of this discussion, a Non-U.S. Holder is any beneficial owner of our common stock that is neither a U.S. person nor an entity or arrangement classified as a partnership for U.S. federal income tax purposes. A U.S. person is any person that, for U.S. federal income tax purposes, is or is treated as any of the following:
| an individual who is a citizen or resident of the U.S.; |
| a corporation created or organized under the laws of the U.S., any state thereof or the District of Columbia; |
| an estate, the income of which is subject to U.S. federal income tax regardless of its source; or |
| a trust that: (i) is subject to the primary supervision of a U.S. court and the control of one or more United States persons (within the meaning of Section 7701(a)(30) of the Code); or (ii) has a valid election in effect to be treated as a U.S. person for U.S. federal income tax purposes. |
Distributions
As described in the section entitled Dividend Policy , we have no present intention to pay cash dividends on our common stock. If, however, we do make distributions of cash or property on our common stock, those distributions will constitute dividends for U.S. federal income tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. Amounts not treated as dividends for U.S. federal income tax purposes will constitute a return of capital and will first be applied against and reduce a Non-U.S. Holders adjusted tax basis in its common stock, but not below zero. Any excess will be treated as capital gain and will be treated as described below under Sale or Other Taxable Disposition.
Subject to the discussion below on effectively connected income, dividends paid to a Non-U.S. Holder of our common stock generally will be subject to U.S. federal withholding tax at a rate of 30% of the gross amount of the dividends (or such lower rate specified by an applicable income tax treaty, provided the Non-U.S. Holder furnishes the applicable withholding agent with a valid IRS Form W-8BEN or W-8BEN-E (or suitable successor or substitute form), as applicable, certifying qualification for the lower treaty rate). A Non-U.S. Holder that does not timely furnish the required documentation, but that qualifies for a reduced treaty rate, may obtain a refund of any excess amounts withheld by timely filing an appropriate claim for refund with the IRS. Non-U.S. Holders should consult their tax advisors regarding their entitlement to benefits under any applicable income tax treaties.
If dividends paid to a Non-U.S. Holder are effectively connected with the Non-U.S. Holders conduct of a trade or business within the U.S. (or, if required by an applicable income tax treaty, the Non-U.S. Holder maintains a permanent establishment in the U.S. to which such dividends are attributable), the Non-U.S. Holder will be exempt from the U.S. federal withholding tax described above. To claim the exemption, the Non-U.S. Holder must furnish to the applicable withholding agent a valid IRS Form W-8ECI (or a suitable successor or substitute form) certifying that the dividends are effectively connected with the Non-U.S. Holders conduct of a trade or business within the U.S.
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However, any such effectively connected dividends will be subject to U.S. federal income tax on a net income basis at the regular graduated rates applicable to U.S. persons. A Non-U.S. Holder that is a corporation also may be subject to a branch profits tax at a rate of 30% (or such lower rate specified by an applicable income tax treaty) on such effectively connected dividends, as adjusted for certain items. Non-U.S. Holders should consult their tax advisors regarding any applicable tax treaties that may provide for different rules.
Sale or Other Taxable Disposition
Subject to the discussion below regarding backup withholding and the Foreign Account Tax Compliance Act (FATCA), a Non-U.S. Holder generally will not be subject to U.S. federal income or withholding tax on any gain realized upon the sale or other taxable disposition of our common stock unless:
| the gain is effectively connected with the Non-U.S. Holders conduct of a trade or business within the U.S. (or, if required by an applicable income tax treaty, the Non-U.S. Holder maintains a permanent establishment in the U.S. to which such gain is attributable); |
| the Non-U.S. Holder is a nonresident alien individual present in the U.S. for 183 days or more during the taxable year of the disposition and certain other requirements are met; or |
| our common stock constitutes a U.S. real property interest (USRPI) by reason of our status as a U.S. real property holding corporation (USRPHC) for U.S. federal income tax purposes. |
Gain described in the first bullet point above generally will be subject to U.S. federal income tax on a net income basis at the regular graduated rates applicable to U.S. persons. A Non-U.S. Holder that is a corporation also may be subject to a branch profits tax at a rate of 30% (or such lower rate specified by an applicable income tax treaty) on such effectively connected gain, as adjusted for certain items.
Gain described in the second bullet point above will be subject to U.S. federal income tax at a rate of 30% (or such lower rate specified by an applicable income tax treaty), which may be offset by U.S. source capital losses of the Non-U.S. Holder (even though the individual is not considered a resident of the U.S.), provided the Non-U.S. Holder has timely filed U.S. federal income tax returns with respect to such losses.
With respect to the third bullet point above, we currently are not, and we do not anticipate becoming, a USRPHC. However, because the determination of whether we are a USRPHC depends on the fair market value of our USRPIs relative to the fair market value of our non-U.S. real property interests and our other business assets, we cannot assure you that we will not become a USRPHC upon or after the Conversion. Even if we become a USRPHC, gain arising from the sale or other taxable disposition by a Non-U.S. Holder of our common stock will not be subject to U.S. federal income tax if our common stock is regularly traded on an established securities market (as such terms are defined by applicable Treasury Regulations), and such Non-U.S. Holder owned, actually and constructively, 5% or less of our common stock throughout the shorter of the 5-year period ending on the date of the sale or other taxable disposition or the Non-U.S. Holders holding period. If we are determined to be a USRPHC and the foregoing exception does not apply, the Non-U.S. Holder generally will be taxed on its net gain derived from the disposition at the graduated U.S. federal income tax rates applicable to U.S. persons. No assurance can be provided that our common stock will be regularly traded on an established securities market for purposes of the rules described above.
Non-U.S. Holders should consult their tax advisors regarding potentially applicable income tax treaties that may provide for different rules.
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Information Reporting and Backup Withholding
Payments of dividends on our common stock generally will not be subject to backup withholding provided the applicable withholding agent does not have actual knowledge or reason to know the Non-U.S. Holder is a U.S. person and the Non-U.S. Holder certifies its non-U.S. status by furnishing a valid IRS Form W-8BEN, W-8BEN-E, W-8ECI, or other applicable IRS form, or otherwise establishes an exemption. Information returns are required to be filed with the IRS in connection with any dividends on our common stock paid to the Non-U.S. Holder, regardless of whether any tax was actually withheld. Copies of these information returns may also be made available under the provisions of an applicable treaty or agreement to the tax authorities of the country in which the Non-U.S. Holder resides or is established.
Information reporting and, depending on the circumstances, backup withholding generally will apply to the proceeds of the sale or other taxable disposition of our common stock within the U.S. or conducted through certain U.S.-related brokers, unless the applicable withholding agent receives the certification described above and does not have actual knowledge or reason to know that the Non-U.S. Holder is a U.S. person, or the holder otherwise establishes an exemption. Proceeds of a disposition of our common stock conducted through a non-U.S. office of a non-U.S. broker that does not have certain enumerated relationships with the U.S. generally will not be subject to backup withholding or information reporting.
Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules may be allowed as a refund or a credit against a Non-U.S. Holders U.S. federal income tax liability, provided the required information is timely furnished to the IRS.
Additional Withholding Tax on Payments Made to Foreign Accounts
Withholding taxes may be imposed under Sections 1471 to 1474 of the Code (such Sections commonly referred to as FATCA) on certain types of payments made to non-U.S. financial institutions and certain other non-U.S. entities. Specifically, a 30% withholding tax may be imposed on dividends on, or gross proceeds from the sale or other disposition of, our common stock paid to a foreign financial institution or a non-financial foreign entity (each as defined in the Code), unless: (i) the foreign financial institution undertakes certain diligence and reporting obligations; (ii) the non-financial foreign entity either certifies it does not have any substantial U.S. owners (as defined in the Code) or furnishes identifying information regarding each substantial U.S. owner; or (iii) the foreign financial institution or non-financial foreign entity otherwise qualifies for an exemption from these rules. If the payee is a foreign financial institution and is subject to the diligence and reporting requirements in (i) above, it must enter into an agreement with the U.S. Department of the Treasury requiring, among other things, that it undertake to identify accounts held by certain specified U.S. persons or United States-owned foreign entities (each as defined in the Code), annually report certain information about such accounts, and withhold 30% on certain payments to noncompliant foreign financial institutions and certain other account holders. Foreign financial institutions located in jurisdictions that have an intergovernmental agreement with the U.S. governing FATCA may be subject to different rules.
Under the applicable Treasury Regulations and administrative guidance, withholding under FATCA generally applies to payments of dividends on our common stock and, beginning on January 1, 2019, will apply to payments of gross proceeds from the sale or other disposition of such stock.
Prospective investors should consult their tax advisors regarding the potential application of withholding tax under FATCA to their investment in our common stock.
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The Company and the underwriters named below will enter into an underwriting agreement with respect to the shares being offered. Subject to certain conditions, each underwriter will severally agree to purchase the number of shares indicated in the following table. Goldman Sachs & Co. LLC and Jefferies LLC are the representatives of the underwriters.
Underwriters |
Number of
Shares |
|||
Goldman Sachs & Co. LLC |
||||
Jefferies LLC |
||||
Cowen and Company, LLC |
||||
|
|
|||
Total |
5,880,000 | |||
|
|
The underwriters will be committed to take and pay for all of the shares being offered, if any are taken, other than the shares covered by the option described below, unless and until this option is exercised.
The underwriters will have an option to buy up to an additional 882,000 shares from the Company to cover sales by the underwriters of a greater number of shares than the total number set forth in the table above. They may exercise that option for 30 days. If any shares are purchased pursuant to this option, the underwriters will severally purchase shares in approximately the same proportion as set forth in the table above.
The following table shows the per share and total underwriting discounts and commissions to be paid to the underwriters by the Company. Such amounts are shown assuming both no exercise and full exercise of the underwriters option to purchase 882,000 additional shares.
Paid by the Company |
No
Exercise |
Full
Exercise |
||||||
Per Share |
$ | $ | ||||||
Total |
$ | $ |
Shares sold by the underwriters to the public will initially be offered at the initial public offering price set forth on the cover of this prospectus. Any shares sold by the underwriters to securities dealers may be sold at a discount of up to $ per share from the initial public offering price. After the initial offering of the shares, the representatives may change the offering price and the other selling terms. The offering of the shares by the underwriters is subject to receipt and acceptance and subject to the underwriters right to reject any order in whole or in part.
The Company and its officers, directors and holders of substantially all of the Companys common stock outstanding immediately prior to the offering have agreed or will agree with the underwriters, subject to certain exceptions, not to dispose of or hedge any of their common stock or securities convertible into or exchangeable for shares of common stock during the period from the date of this prospectus continuing through the date 180 days after the date of this prospectus, except with the prior written consent of the representatives. See Shares Eligible for Future Sale for a discussion of certain transfer restrictions.
Prior to the offering, there has been no public market for the shares. The initial public offering price will be negotiated among the Company and the representatives. Among the factors to be considered in determining the initial public offering price of the shares, in addition to prevailing market conditions, will be the Companys historical performance, estimates of the business potential and earnings prospects of the Company, an assessment of the Companys management and the consideration of the above factors in relation to market valuation of companies in related businesses.
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The Company has applied to list the common stock on the NASDAQ Global Select Market under the symbol ODT.
In connection with the offering, the underwriters may purchase and sell shares of common stock in the open market. These transactions may include short sales, stabilizing transactions and purchases to cover positions created by short sales. Short sales involve the sale by the underwriters of a greater number of shares than they are required to purchase in the offering, and a short position represents the amount of such sales that have not been covered by subsequent purchases. A covered short position is a short position that is not greater than the amount of additional shares for which the underwriters option described above may be exercised. The underwriters may cover any covered short position by either exercising their option to purchase additional shares or purchasing shares in the open market. In determining the source of shares to cover the covered short position, the underwriters will consider, among other things, the price of shares available for purchase in the open market as compared to the price at which they may purchase additional shares pursuant to the option described above. Naked short sales are any short sales that create a short position greater than the amount of additional shares for which the option described above may be exercised. The underwriters must cover any such naked short position by purchasing shares in the open market. A naked short position is more likely to be created if the underwriters are concerned that there may be downward pressure on the price of the common stock in the open market after pricing that could adversely affect investors who purchase in the offering. Stabilizing transactions consist of various bids for, or purchases of, common stock made by the underwriters in the open market prior to the completion of the offering.
The underwriters may also impose a penalty bid. This occurs when a particular underwriter repays to the underwriters a portion of the underwriting discount received by it because the representatives have repurchased shares sold by or for the account of such underwriter in stabilizing or short-covering transactions.
Purchases to cover a short position and stabilizing transactions, as well as other purchases by the underwriters for their own accounts, may have the effect of preventing or retarding a decline in the market price of the Companys common stock, and together with the imposition of the penalty bid, may stabilize, maintain or otherwise affect the market price of the common stock. As a result, the price of the common stock may be higher than the price that otherwise might exist in the open market. The underwriters are not required to engage in these activities and may end any of these activities at any time. These transactions may be effected on NASDAQ, in the over-the-counter market or otherwise.
The Company estimates that its share of the total expenses of the offering, excluding underwriting discounts and commissions, will be approximately $2.3 million. The Company will also agree to reimburse the underwriters for certain of their expenses in an amount up to $40,000.
The Company will agree to indemnify the several underwriters against certain liabilities, including liabilities under the Securities Act of 1933, as amended.
The underwriters and their respective affiliates are full-service financial institutions engaged in various activities, which may include sales and trading, commercial and investment banking, advisory, investment management, investment research, principal investment, hedging, market making, brokerage and other financial and non-financial activities and services. Certain of the underwriters and their respective affiliates have provided, and may in the future provide, a variety of these services to the Company and to persons and entities with relationships with the Company, for which they received or will receive customary fees and expenses.
In the ordinary course of their various business activities, the underwriters and their respective affiliates, officers, directors and employees may purchase, sell or hold a broad array of investments
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and actively trade securities, derivatives, loans, commodities, currencies, credit default swaps and other financial instruments for their own account and for the accounts of their customers, and such investment and trading activities may involve or relate to assets, securities and/or instruments of the Company (directly, as collateral securing other obligations or otherwise) and/or persons and entities with relationships with the Company. The underwriters and their respective affiliates may also communicate independent investment recommendations, market color or trading ideas and/or publish or express independent research views in respect of such assets, securities or instruments and may at any time hold, or recommend to clients that they should acquire, long and/or short positions in such assets, securities and instruments.
Selling Restrictions
European Economic Area
In relation to each Member State of the European Economic Area that has implemented the Prospectus Directive (each, a Relative Member State), an offer to the public of our common stock may not be made in that Relevant Member State, except that an offer to the public in that Relevant Member State of our common stock may be made at any time under the following exemptions under the Prospectus Directive:
| To any legal entity that is a qualified investor as defined in the Prospectus Directive; |
| To fewer than 150 natural or legal persons (other than qualified investors as defined in the Prospectus Directive), subject to obtaining the prior consent of the representatives for any such offer; or |
| In any other circumstances falling within Article 3(2) of the Prospectus Directive; |
provided, that no such offer of shares of our common stock shall result in a requirement for the publication by us or any placement agent of a prospectus pursuant to Article 3 of the Prospectus Directive.
For the purposes of this provision, the expression of an offer to public in relation to our common stock in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and our common stock to be offered so as to enable an investor to decide to purchase our common stock, as the same may be varied in that Relevant Member State by any measure implementing the Prospectus Directive in that Relevant Member State. The expression Prospectus Directive means Directive 2003/71/EC (as amended), including by Directive 2010/73/EU and includes any relevant implementing measure in the Relevant Member State.
This European Economic Area selling restriction is in addition to any other selling restrictions set out below.
United Kingdom
In the United Kingdom, this prospectus is only addressed to and directed at qualified investors who are: (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the Order); or (ii) high-net-worth entities and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as Relevant Persons). Any investment or investment activity to which this prospectus relates is available only to Relevant Persons and will only be engaged with Relevant Persons. Any person who is not a Relevant Person should not act or rely on this prospectus or any of its contents.
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Canada
The securities may be sold in Canada only to purchasers purchasing, or deemed to be purchasing, as principal who are accredited investors, as defined in National Instrument 45-106 Prospectus Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permitted clients, as defined in National Instrument 31-103 Registration Requirements, Exemptions, and Ongoing Registrant Obligations. Any resale of the securities must be made in accordance with an exemption form, or in a transaction not subject to, the prospectus requirements of applicable securities laws.
Securities legislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if this offering memorandum (including any amendment thereto) contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchasers province or territory. The purchaser should refer to any applicable provisions of the securities legislation of the purchasers province or territory with respect to these rights or consult with a legal advisor.
Pursuant to section 3A.3 of National Instrument 33-105 Underwriting Conflicts (NI 33-105), the underwriters are not required to comply with the disclosure requirements of NI 33-105 regarding underwriter conflicts of interest in connection with this offering.
Hong Kong
The shares may not be offered or sold in Hong Kong by means of any document other than: (i) in circumstances that do not constitute an offer to the public within the meaning of the Companies (Winding Up and Miscellaneous Provisions) Ordinance (Cap. 32 of the Laws of Hong Kong) (Companies (Winding Up and Miscellaneous Provisions) Ordinance) or that do not constitute an invitation to the public within the meaning of the Securities and Futures Ordinance (Cap. 571 of the Laws of Hong Kong) (Securities and Futures Ordinance); (ii) to professional investors as defined in the Securities and Futures Ordinance and any rules made thereunder; or (iii) in other circumstances that do not result in the document being a prospectus as defined in the Companies (Winding Up and Miscellaneous Provisions) Ordinance, and no advertisement, invitation or document relating to the shares may be issued or may be in the possession of any person for the purpose of issue (in each case whether in Hong Kong or elsewhere), that is directed at, or the contents of which are likely to be accessed or read by, the public in Hong Kong (except if permitted to do so under the securities laws of Hong Kong) other than with respect to shares that are, or are intended to be, disposed of only to persons outside Hong Kong or professional investors in Hong Kong.
Singapore
This prospectus has not been registered as a prospectus with the Monetary Authority of Singapore. Accordingly, this prospectus and any other document or material in connection with the offer or sale, or invitation for subscription or purchase, of the shares may not be circulated or distributed, nor may the shares be offered or sold, or be made the subject of an invitation for subscription or purchase, whether directly or indirectly, to persons in Singapore other than: (i) to an institutional investor (as defined under Section 4A of the Securities and Futures Act, Chapter 289 of Singapore (the SFA)) under Section 274 of the SFA; (ii) to a relevant person (as defined in Section 275(2) of the SFA) pursuant to Section 275(1) of the SFA, or any person pursuant to Section 275(1A) of the SFA, and in accordance with the conditions specified in Section 275 of the SFA; or (iii) otherwise pursuant to, and in accordance with the conditions of, any other applicable provision of the SFA, in each case subject to conditions set forth in the SFA.
Where the shares are subscribed or purchased under Section 275 of the SFA by a relevant person that is a corporation (that is not an accredited investor (as defined in Section 4A of the SFA))
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the sole business of which is to hold investments and the entire share capital of which is owned by one or more individuals, each of whom is an accredited investor, the securities (as defined in Section 239(1) of the SFA) of that corporation shall not be transferable for 6 months after that corporation has acquired the shares under Section 275 of the SFA, except: (i) to an institutional investor under Section 274 of the SFA or to a relevant person (as defined in Section 275(2) of the SFA); (ii) where such transfer arises from an offer in that corporations securities pursuant to Section 275(1A) of the SFA; (iii) where no consideration is or will be given for the transfer; (iv) where the transfer is by operation of law; (v) as specified in Section 276(7) of the SFA; or (vi) as specified in Regulation 32 of the Securities and Futures (Offers of Investments) (Shares and Debentures) Regulations 2005 of Singapore (Regulation 32).
Where the shares are subscribed or purchased under Section 275 of the SFA by a relevant person that is a trust (where the trustee is not an accredited investor (as defined in Section 4A of the SFA)) whose sole purpose is to hold investments, and each beneficiary of the trust is an accredited investor, the beneficiaries rights and interest (howsoever described) in that trust shall not be transferable for 6 months after that trust has acquired the shares under Section 275 of the SFA, except: (i) to an institutional investor under Section 274 of the SFA or to a relevant person (as defined in Section 275(2) of the SFA); (ii) where such transfer arises from an offer that is made on terms that such rights or interest are acquired for consideration of not less than S$200,000 (or its equivalent in a foreign currency) for each transaction (whether such amount is to be paid for in cash or by exchange of securities or other assets); (iii) where no consideration is or will be given for the transfer; (iv) where the transfer is by operation of law; (v) as specified in Section 276(7) of the SFA; or (vi) as specified in Regulation 32.
Japan
The securities have not been and will not be registered under the Financial Instruments and Exchange Act of Japan (Act No. 25 of 1948, as amended) (FIEA). The securities may not be offered or sold, directly or indirectly, in Japan or to or for the benefit of any resident of Japan (including any resident in Japan or any corporation or other entity organized under the laws of Japan) or to others for reoffering or resale, directly or indirectly, in Japan or to or for the benefit of any resident of Japan, except pursuant to an exemption from the registration requirements of the FIEA and otherwise in compliance with any relevant laws and regulations of Japan.
120
The validity of the shares of common stock offered by this prospectus will be passed upon for us by Gibson, Dunn & Crutcher LLP, San Francisco, California. Certain legal matters in connection with this offering will be passed upon for the underwriters by Latham & Watkins LLP, Menlo Park, California.
The financial statements of Odonate Therapeutics, LLC as of December 31, 2015 and 2016 and for each of the years in the two-year period ended December 31, 2016 have been audited by Squar Milner LLP, an independent registered public accounting firm, as stated in their report thereon and included in this prospectus and registration statement in reliance upon such report and upon the authority of such firm as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the common stock. This prospectus, which constitutes a part of the registration statement, does not contain all of the information set forth in the registration statement, some items of which are contained in exhibits to the registration statement as permitted by the rules and regulations of the SEC. For further information with respect to us and our common stock, we refer you to the registration statement, including the exhibits and the financial statements and notes filed as a part of the registration statement. Statements contained in this prospectus concerning the contents of any contract or any other document are not necessarily complete. If a contract or document has been filed as an exhibit to the registration statement, please see the copy of the contract or document that has been filed. Each statement in this prospectus relating to a contract or document filed as an exhibit is qualified in all respects by the filed exhibit. The exhibits to the registration statement should be reviewed for the complete contents of these contracts and documents. A copy of the registration statement, including the exhibits and the financial statements and notes filed as a part of the registration statement, may be inspected without charge at the SECs Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549, and copies of all or any part of the registration statement may be obtained from the SEC upon the payment of fees prescribed by it. You may call the SEC at 1-800-SEC-0330 for more information on the operation of the public reference facilities. The SEC maintains a website at www.sec.gov that contains reports, proxy and information statements and other information regarding companies that file electronically with it.
Upon completion of this offering, we will become subject to the information and periodic and current reporting requirements of the Exchange Act, and in accordance therewith, will file periodic and current reports, proxy statements and other information with the SEC. The registration statement, such periodic and current reports and other information can be inspected and copied at the Public Reference Room of the SEC located at 100 F Street, N.E., Washington, D.C. 20549. Copies of such materials, including copies of all or any portion of the registration statement, can be obtained from the Public Reference Room of the SEC at prescribed rates. You can call the SEC at 1-800-SEC-0330 to obtain information on the operation of the Public Reference Room. Such materials may also be accessed electronically by means of the SECs website at www.sec.gov.
121
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors
Odonate Therapeutics, LLC
We have audited the accompanying balance sheets of Odonate Therapeutics, LLC as of December 31, 2015 and 2016, and the related statements of operations, members equity, and cash flows for the years then ended. These financial statements are the responsibility of the Companys management. Our responsibility is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Companys internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Odonate Therapeutics, LLC at December 31, 2015 and 2016, and the results of its operations and its cash flows for the years then ended, in conformity with U.S. generally accepted accounting principles.
/s/ Squar Milner LLP
San Diego, California
September 29, 2017
except for Note 9, as to which the date is November 27, 2017
F-2
ODONATE THERAPEUTICS, LLC
(in thousands, except unit amounts)
December 31, |
September 30,
2017 |
|||||||||||
2015 | 2016 | |||||||||||
(unaudited) | ||||||||||||
Assets |
||||||||||||
Current assets: |
||||||||||||
Cash |
$ | 138 | $ | 2,599 | $ | 74,504 | ||||||
Prepaid expenses |
2 | 268 | 1,091 | |||||||||
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|
|
|
|
|
|||||||
Total current assets |
140 | 2,867 | 75,595 | |||||||||
Property and equipment, net |
- | 14 | 93 | |||||||||
Other |
- | - | 827 | |||||||||
|
|
|
|
|
|
|||||||
Total assets |
$ | 140 | $ | 2,881 | $ | 76,515 | ||||||
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|
|
|
|
|||||||
Liabilities and Members Equity |
||||||||||||
Current liabilities: |
||||||||||||
Accounts payable |
$ | 29 | $ | 572 | $ | 1,004 | ||||||
Accrued expenses |
- | 26 | 2,327 | |||||||||
|
|
|
|
|
|
|||||||
Total current liabilities |
29 | 598 | 3,331 | |||||||||
Commitments and contingencies (Note 3) |
||||||||||||
Members equity: |
||||||||||||
Common units922,706 units, 10,147,798 units and 17,708,954 units issued and outstanding at December 31, 2015 and 2016 and September 30, 2017 (unaudited), respectively |
3,574 | 7,768 | 91,739 | |||||||||
Incentive unitsno units, 1,934,716 units and 2,365,950 units issued and outstanding at December 31, 2015 and 2016 and September 30, 2017 (unaudited), respectively |
- | - | - | |||||||||
Non-cash contributed capital |
- | 1,063 | 4,991 | |||||||||
Accumulated deficit |
(3,463 | ) | (6,548 | ) | (23,546 | ) | ||||||
|
|
|
|
|
|
|||||||
Total members equity |
111 | 2,283 | 73,184 | |||||||||
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|
|
|
|
|
|||||||
Total liabilities and members equity |
$ | 140 | $ | 2,881 | $ | 76,515 | ||||||
|
|
|
|
|
|
See accompanying notes.
F-3
ODONATE THERAPEUTICS, LLC
(in thousands, except unit and per unit amounts)
Year Ended
December 31, |
Nine Months Ended
September 30, |
|||||||||||||||
2015 | 2016 | 2016 | 2017 | |||||||||||||
(unaudited) | ||||||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
$ | - | $ | 2,622 | $ | 856 | $ | 14,862 | ||||||||
General and administrative |
158 | 463 | 283 | 2,136 | ||||||||||||
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|
|
|
|
|
|
|
|||||||||
Total operating expenses |
158 | 3,085 | 1,139 | 16,998 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss attributable to common unitholders |
$ | (158 | ) | $ | (3,085 | ) | $ | (1,139 | ) | $ | (16,998 | ) | ||||
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|
|
|
|
|
|
|
|||||||||
Net loss per unit attributable to common unitholders: |
||||||||||||||||
Basic and diluted |
$ | (0.17 | ) | $ | (0.54 | ) | $ | (0.27 | ) | $ | (1.37 | ) | ||||
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|
|
|
|
|
|
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Weighted average units outstanding: |
||||||||||||||||
Basic and diluted |
922,706 | 5,762,419 | 4,289,956 | 12,427,219 | ||||||||||||
|
|
|
|
|
|
|
|
See accompanying notes.
F-4
ODONATE THERAPEUTICS, LLC
(in thousands, except unit amounts)
Common | Incentive |
Non-Cash
Contributed Capital |
Accumulated
Deficit |
Total
Members Equity |
||||||||||||||||||||||||
Units | Amount | Units | Amount | |||||||||||||||||||||||||
Balance at December 31, 2014 |
922,706 | $ | 3,574 | - | $ | - | $ | - | $ | (3,305 | ) | $ | 269 | |||||||||||||||
Net loss |
- | - | - | - | - | (158 | ) | (158 | ) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance at December 31, 2015 |
922,706 | 3,574 | - | - | - | (3,463 | ) | 111 | ||||||||||||||||||||
Redemption of common units |
(58,670 | ) | (32 | ) | - | - | - | - | (32 | ) | ||||||||||||||||||
Issuance of common units for cash, net of issuance costs |
9,283,762 | 5,017 | - | - | - | - | 5,017 | |||||||||||||||||||||
Non-cash contribution for expenses |
- | - | - | - | 1,012 | - | 1,012 | |||||||||||||||||||||
Issuance of incentive units |
- | - | 1,934,716 | - | - | - | - | |||||||||||||||||||||
Equity-based compensation |
- | - | - | - | 51 | - | 51 | |||||||||||||||||||||
Distributions |
- | (791 | ) | - | - | - | - | (791 | ) | |||||||||||||||||||
Net loss |
- | - | - | - | - | (3,085 | ) | (3,085 | ) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance at December 31, 2016 |
10,147,798 | 7,768 | 1,934,716 | - | 1,063 | (6,548 | ) | 2,283 | ||||||||||||||||||||
Issuance of common units for cash, net of issuance costs (unaudited) |
7,561,156 | 83,971 | - | - | - | - | 83,971 | |||||||||||||||||||||
Non-cash contribution for expenses (unaudited) |
- | - | - | - | 1,730 | - | 1,730 | |||||||||||||||||||||
Issuance of incentive units, net (unaudited) |
- | - | 431,234 | - | - | - | - | |||||||||||||||||||||
Equity-based compensation (unaudited) |
- | - | - | - | 2,198 | - | 2,198 | |||||||||||||||||||||
Net loss (unaudited) |
- | - | - | - | - | (16,998 | ) | (16,998 | ) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance at September 30, 2017 (unaudited) |
17,708,954 | $ | 91,739 | 2,365,950 | $ | - | $ | 4,991 | $ | (23,546 | ) |
$
|
73,184
|
|
||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-5
ODONATE THERAPEUTICS, LLC
(in thousands)
Year Ended
December 31, |
Nine Months Ended
September 30, |
|||||||||||||||
2015 | 2016 | 2016 | 2017 | |||||||||||||
(unaudited) | ||||||||||||||||
Cash flows from operating activities: |
||||||||||||||||
Net loss |
$ | (158 | ) | $ | (3,085 | ) | $ | (1,139 | ) | $ | (16,998 | ) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||||||
Depreciation |
- | - | - | 10 | ||||||||||||
Equity-based compensation |
- | 51 | 24 | 2,198 | ||||||||||||
Non-cash contribution for expenses |
- | 1,012 | 447 | 1,730 | ||||||||||||
Changes in operating assets and liabilities: |
||||||||||||||||
Prepaid expenses and other assets |
(2 | ) | (266 | ) | (132 | ) | (864 | ) | ||||||||
Accounts payable |
4 | 529 | 48 | (50 | ) | |||||||||||
Accrued expenses |
(9 | ) | 26 | - | 2,191 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net cash used in operating activities |
(165 | ) | (1,733 | ) | (752 | ) | (11,783 | ) | ||||||||
Cash flows from investing activities: |
||||||||||||||||
Purchases of property and equipment |
- | - | - | (68 | ) | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net cash used in investing activities |
- | - | - | (68 | ) | |||||||||||
Cash flows from financing activities: |
||||||||||||||||
Proceeds from issuance of common units, net of issuance costs |
- | 5,017 | 5,017 | 83,974 | ||||||||||||
Redemption of common units |
- | (32 | ) | (32 | ) | - | ||||||||||
Initial public offering costs |
- | - | - | (218 | ) | |||||||||||
Distributions |
- | (791 | ) | - | - | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net cash provided by financing activities |
- | 4,194 | 4,985 | 83,756 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net increase (decrease) in cash |
(165 | ) | 2,461 | 4,233 | 71,905 | |||||||||||
Cash, beginning of period |
303 | 138 | 138 | 2,599 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Cash, end of period |
$ | 138 | $ | 2,599 | $ | 4,371 | $ | 74,504 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Supplemental disclosure of cash flow information: |
||||||||||||||||
Issuance costs included in accounts payable and accrued expenses |
$ | - | $ | - | $ | - | $ | 571 | ||||||||
Property and equipment purchases included in accounts payable |
$ | - | $ | 14 | $ | - | $ | 35 |
See accompanying notes.
F-6
ODONATE THERAPEUTICS, LLC
1. Organization, Basis of Presentation and Summary of Significant Accounting Policies
Organization
Odonate Therapeutics, LLC (Odonate or the Company) was formed in Delaware in March 2013. Odonate is a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer. The Companys initial focus is on the development of tesetaxel, a novel chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several potential therapeutic advantages over currently available taxanes, including: oral administration with a low pill burden and a patient-friendly dosing regimen; a formulation that does not contain solubilizing agents that are known to cause hypersensitivity (allergic) reactions; and improved activity against chemotherapy-resistant tumors. Tesetaxel has been generally well tolerated in clinical studies and has demonstrated robust single-agent antitumor activity in two Phase 2 studies in patients with locally advanced or metastatic breast cancer (MBC). The Company expects to begin enrolling patients in a multinational, multicenter, randomized, Phase 3 study in MBC, known as CONTESSA, in the fourth quarter of 2017 and report top-line results from this study in 2020. The Companys goal for tesetaxel is to develop an effective chemotherapy choice for patients that provides quality-of-life advantages over current alternatives.
Liquidity and Capital Resources
The Company has incurred net losses since its inception. For the year ended December 31, 2016, the Company incurred a net loss of $3.1 million and used $1.7 million of cash to fund operating activities. For the nine months ended September 30, 2017, the Company incurred a net loss of $17.0 million and used $11.8 million of cash to fund operating activities. As of September 30, 2017, the Company had an accumulated deficit of $23.5 million and cash of $74.5 million. Management expects net losses and negative cash flows to continue for at least the next year as the Company continues to incur costs related to the ongoing development of tesetaxel, which will include costs associated with the initiation and conduct of CONTESSA, a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with locally advanced or metastatic breast cancer.
As of December 31, 2016, the Company adopted Accounting Standard Update (ASU) No. 2014-15, Disclosure of Uncertainties About an Entitys Ability to Continue as a Going Concern (ASU 2014-15), which requires management to evaluate whether there are conditions or events that raise substantial doubt about the Companys ability to continue as a going concern and to meet its obligations as they become due within one year from the date the financial statements are issued. Based on the Companys cash and working capital as of September 30, 2017, and the Companys current operating plans and projections, management believes that the available cash will be sufficient to fund operations for at least 12 months from the date these financial statements are issued. However, to fund future operations to the point at which the Company is able to generate positive cash flow from sales of tesetaxel or other potential product candidates, the Company will need to raise significant additional capital. The amount and timing of future funding requirements will depend on many factors, including the timing and results of the Companys ongoing development efforts, the potential expansion of the Companys current development programs, potential new development programs and related general and administrative support. Management anticipates that the Company will seek to fund its operations through public and private equity and debt financings or other sources, such as potential licenses or other collaboration agreements. Management cannot provide any assurances that anticipated additional financing will be available to the Company on favorable terms, or at all. Although the Company has been successful in obtaining financing through equity securities offerings, there can
F-7
ODONATE THERAPEUTICS, LLC
Notes to Financial Statements
be no assurance that it will be able to do so in the future. If the Company is unable to raise additional capital to fund its clinical development and commercialization of tesetaxel, if approved, and other business activities, the Company could be forced to abandon one or more programs and curtail its operations.
Use of Estimates
The Companys financial statements are prepared in accordance with generally accepted accounting principles in the U.S. (GAAP). The preparation of the Companys financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the Companys financial statements and accompanying notes. The most significant estimates in the Companys financial statements relate to accrued expenses and equity-based compensation. These estimates and assumptions are based on current facts, historical experience and various other factors 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 and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Companys future results of operations will be affected.
Reverse Split
In August 2016, the Company completed a reverse split pursuant to which one common unit was issued for every 50 units outstanding before the split. The accompanying financial statements and notes to the financial statements give retroactive effect to the reverse split for all periods presented.
Unaudited Interim Financial Information
The accompanying interim balance sheet as of September 30, 2017, the statements of operations and cash flows for the nine months ended September 30, 2016 and 2017 and the statement of members equity for the nine months ended September 30, 2017 and the related footnote disclosures are unaudited. In managements opinion, the unaudited interim financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Companys financial position as of September 30, 2017 and its results of operations and cash flows for the nine months ended September 30, 2016 and 2017 in accordance with GAAP. The results for the nine months ended September 30, 2017 are not necessarily indicative of the results expected for the full fiscal year or any other interim period.
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. The Company views its operations and manages its business in one operating segment.
Fair Value Measurements
The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on
F-8
ODONATE THERAPEUTICS, LLC
Notes to Financial Statements
either a recurring or non-recurring basis. Fair value is defined as an 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 accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
Level 1: | Observable inputs such as quoted prices in active markets. |
Level 2: | Inputs, other than the quoted prices in active markets that are observable either directly or indirectly. |
Level 3: | Unobservable inputs for which there are little or no market data, which require the reporting entity to develop its own assumptions. |
The carrying amounts of the Companys cash, prepaid expenses, accounts payable and accrued expenses are considered to be representative of their respective fair values because of the short-term nature of those instruments. As of December 31, 2015 and 2016 and September 30, 2017, the Company had no financial assets or liabilities measured at fair value on a recurring basis.
Cash
The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. The Company maintains its cash in a checking account. As of December 31, 2015 and 2016 and September 30, 2017, the Company held no cash equivalents.
Concentrations of Risk
Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held.
Property and Equipment
Property and equipment, generally consisting of office equipment and software, is stated at cost and depreciated on a straight-line basis over the estimated useful life of the related assets.
Research and Development Expenses
Research and development expenses consist primarily of costs associated with the development of the Companys product candidates and include salaries, benefits, travel and other related cost, including equity-based compensation expenses, for personnel engaged in research and development functions; expenses incurred under agreements with contract research organizations (CROs), investigative sites and consultants that conduct the Companys preclinical and clinical studies; manufacturing development and scale-up expenses and the cost of acquiring and manufacturing clinical study materials and commercial materials, including manufacturing registration and validation batches; payments to consultants engaged in the development of our product candidates, including equity-based compensation, travel and other expenses; costs related to compliance with quality and regulatory requirements; research and development facility-related expenses, which include direct and allocated expenses and other related costs.
F-9
ODONATE THERAPEUTICS, LLC
Notes to Financial Statements
Research and development expenses are charged to operations as incurred when these expenditures relate to the Companys research and development efforts and have no alternative future uses. Payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received.
Patent Costs
Costs related to filing and pursuing patent applications are recorded as general and administrative expenses and expensed as incurred since recoverability of such expenditures is uncertain.
Equity-based Compensation
The Company issues incentive units, considered profits interests within the meaning of U.S. federal and state tax rules, at various times to employees, consultants and certain directors. Equity-based compensation expense represents the cost of the grant-date fair value of employee awards recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. The Company accounts for awards to non-employees using the fair value approach. Non-employee awards are subject to periodic revaluation over their vesting terms.
Income Taxes
The Company has operated as a limited liability company (LLC). An LLC combines a corporations protection from personal liability for business debts along with the pass-through tax structure of a partnership or sole proprietorship. Business income passes through the business to the LLC members, who report their share of profits or losses on their individual income tax returns. Accordingly, no provision for income taxes is reflected in the Companys financial statements. The Companys tax returns are subject to examination by federal and state taxing authorities. If such examinations result in adjustments to the income or expense amounts, the amounts allocated to the LLC members could be adjusted accordingly.
The Company files income tax returns in the U.S. and various state jurisdictions. The Company evaluates tax positions taken or expected to be taken in the course of preparing its tax returns and disallows the recognition of tax positions not deemed to meet a more-likely-than-not threshold of being sustained by the applicable tax authority. The Company does not believe there are any tax positions taken within the financial statements that would not meet this threshold. The Companys policy is to record interest and penalties, if any, related to uncertain tax positions as a component of general and administrative expenses. The Company is not currently undergoing a tax audit in any federal or state jurisdiction. However, the tax years 2014 through 2016 remain open to examination for federal income tax purposes and by the other major taxing jurisdictions.
Comprehensive Loss
Comprehensive loss is defined as a change in equity during a period from transactions and other events and circumstances from non-owner sources. There have been no items qualifying as other comprehensive loss, and, therefore, for all periods presented, the Companys comprehensive loss was the same as its reported net loss.
F-10
ODONATE THERAPEUTICS, LLC
Notes to Financial Statements
Recent Accounting Pronouncements
In August 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-15, Presentation of Financial StatementsGoing Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entitys Ability to Continue as a Going Concern (ASU 2014-15). The new standard requires management to assess, at each annual and interim reporting period, an entitys ability to continue as a going concern within one year after the date that the financial statements are issued and to provide related footnote disclosures. The amendments are effective for public business entities for fiscal years ending after December 15, 2016. The Company adopted this guidance during the year ended December 31, 2016 with no material impact on its financial statements.
In February 2016, the FASB issued ASU No. 2016-02, Leases (ASU 2016-02). This guidance requires recognition of lease assets and lease liabilities on the balance sheet and disclosure of key information about leasing arrangements. ASU 2016-02 is effective for annual reporting periods beginning after December 15, 2018 and interim periods thereafter. Early adoption is permitted. The guidance is required to be adopted at the earliest period presented using a modified retrospective approach. The Company is evaluating the impact the adoption of ASU 2016-02 will have on its financial statements and disclosures.
In March 2016, the FASB issued ASU No. 2016-09, Stock Compensation (ASU 2016-09). This guidance identifies areas for simplification involving several aspects of accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, an option to estimate forfeitures or recognize actual forfeitures as they occur, as well as certain classifications on the statement of cash flows. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016 and interim periods thereafter. The Company adopted this guidance prospectively during the year ended December 31, 2016 with no material impact on its financial statements and disclosures.
In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230), Classification of Certain Cash Receipts and Cash Payments (ASU 2016-15). ASU 2016-15 is intended to address how certain cash receipts and cash payments are presented and classified in the statement of cash flows. This update addresses 8 specific cash flow issues with the objective of reducing the existing diversity in practice. The amendments are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted. The Company adopted this guidance prospectively during the year ended December 31, 2016 with no material impact on its financial statements.
In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (ASU 2016-18). ASU 2016-18 is intended to address diversity in practice that exists in the classification and presentation of changes in restricted cash on the statement of cash flows. The amendments require that a statement of cash flows explain the change during the period in the total of cash, cash equivalents and amounts generally described as restricted cash or restricted cash equivalents. The amendments are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted. The Company adopted this guidance prospectively during the year ended December 31, 2016 with no material impact on its financial statements.
In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business (ASU 2017-01). The purpose of the amendment is to clarify the
F-11
ODONATE THERAPEUTICS, LLC
Notes to Financial Statements
definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions of assets or businesses. The amendments are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. The Company is evaluating the impact the adoption of ASU 2017-01 will have on its financial statements and disclosures.
Net Loss per Unit
The Company calculates net loss per unit under the two-class method. The Company has two forms of participating securities: common units and incentive units. However, incentive units, which are considered profits interests, do not participate in distributed or undistributed net losses because they are not contractually obligated to do so. Therefore, net loss per unit is presented solely with respect to those losses attributable to common units.
Basic net loss per unit is calculated by dividing net loss attributable to common units by the weighted average common units outstanding during the period, without consideration of common-unit equivalents. Diluted net loss per unit is calculated by adjusting weighted average units outstanding for the dilutive effect of common-unit equivalents outstanding for the period. For purposes of the diluted net loss per unit calculation, incentive units are considered to be common-unit equivalents but are excluded from the calculation of diluted net loss per common unit if their effect would be anti-dilutive.
2. Accrued Expenses
Accrued expenses consist of the following (in thousands):
December 31, | September 30, | |||||||||||
2015 | 2016 | 2017 | ||||||||||
Accrued compensation and related expenses |
$ | - | $ | 26 | $ | 1,008 | ||||||
Other accrued expenses |
- | - | 1,319 | |||||||||
|
|
|
|
|
|
|||||||
$ | - | $ | 26 | $ | 2,327 | |||||||
|
|
|
|
|
|
3. Commitments and Contingencies
Commitments
The Company enters into contracts in the normal course of business with CROs, contract development and manufacturing organizations and other service providers and vendors. These contracts generally provide for termination on notice and, therefore, are cancelable contracts and not considered contractual obligations and commitments.
Contingencies
From time to time, the Company may become subject to claims and litigation arising in the ordinary course of business. The Company is not a party to any material legal proceedings, nor is it aware of any pending or threatened litigation.
F-12
ODONATE THERAPEUTICS, LLC
Notes to Financial Statements
4. Members Equity
Operating Agreement
The Companys operating agreement, as amended and restated, provides for classes of units, allocation of profits and losses, distribution preferences, other member rights and the management of the LLC. The operating agreement designates common units and incentive units. The incentive units are non-voting and members are limited in their liability to their capital contributions.
Distributions
Distributions will be made to each unitholder based on such unitholders pro-rata share of total outstanding units; however, incentive units are subject to threshold limitations. Further, no distribution shall be made to a member to the extent it would cause such member to have a deficit capital account. Distributions to unvested incentive units are credited to a memorandum account and, subject to such incentive units becoming vested, distributed at the time of the next distribution to the common units. The Company made a one-time distribution to common unitholders of $0.8 million in December 2016.
Common Unit Sales and Capital Contributions
In 2013, the Company raised $1.8 million (net of $26,000 of issuance costs) in cash and received contributions of secured promissory notes issued by Genta Incorporated with an aggregate fair value of $1.8 million (the Genta Notes) through the sale of 922,706 common units at $3.90 per common unit. The Genta Notes were used to acquire tesetaxel from the Genta Incorporated bankruptcy estate. The cash proceeds were used for the payment of legal and organizational costs incurred of $1.0 million.
In June 2016, the Company raised $5.0 million in cash (net of $15,000 of issuance costs) through the sale of 9,283,762 common units at $0.54 per common unit to certain existing investors. During June 2016, the Company also redeemed 58,670 common units for an aggregate of $32,000.
In March 2017, the Company raised $10.0 million in cash (net of $14,000 of issuance costs) through the sale of 2,593,024 common units at $3.86 per common unit to certain existing investors.
In September 2017, the Company raised $74.0 million in cash (net of $15,000 of issuance costs) through the sale of 4,968,132 common units at $14.90 per common unit to new and certain existing investors.
For the year ended December 31, 2016 and the nine months ended September 30, 2016 and 2017, the Company recorded non-cash contribution for expenses of $1.0 million, $0.4 million and $1.7 million, respectively, related to certain costs incurred on behalf of the Company and recorded corresponding increases to non-cash contributed capital (see Note 7).
5. Equity Incentive Plan
On August 4, 2016, the Company adopted the Odonate Management Holdings Equity Incentive Plan (the Plan) in order to allow for directors, officers, employees and consultants of Odonate (the Plan Participants) to share in the performance of the Company. The incentive units issued under the Plan were issued to Odonate Management Holdings, LLC, which issues incentive units to the Plan Participants on the same terms and conditions. The incentive units generally vest over 4 years, are subject to continued service requirements and only provide the Plan Participants with benefits (in the form of distributions) if the distributions from Odonate exceed specified base prices. Generally, upon
F-13
ODONATE THERAPEUTICS, LLC
Notes to Financial Statements
termination of services, all unvested incentive units are forfeited to the Company. Further, certain incentive units granted in the year ended December 31, 2016 contained anti-dilution provisions that would have required additional incentive units to be provided to the incentive unitholder upon specified levels of dilution. In 2017, as a result of the September 2017 Financing, the existing anti-dilution provisions expired.
The activity of unvested incentive units under the Plan are summarized as follows:
Incentive Unit
Vesting |
Weighted Average
Base Price per Incentive Unit |
|||||||
Unvested at December 31, 2015 |
- | - | ||||||
Granted |
1,934,716 | $ | 0.54 | |||||
Vested |
- | - | ||||||
|
|
|
|
|||||
Unvested at December 31, 2016 |
1,934,716 | $ | 0.54 | |||||
Granted |
1,031,174 | $ | 2.59 | |||||
Vested |
(360,294 | ) | $ | 0.54 | ||||
Forfeited |
(599,940 | ) | $ | 0.54 | ||||
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|
|
|
|||||
Unvested at September 30, 2017 |
2,005,656 | $ | 1.60 | |||||
|
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The outstanding incentive units are summarized as follows:
As of |
Incentive
Units Outstanding |
Vested
Incentive Units Outstanding |
Unvested
Incentive Units Outstanding |
Weighted
Average Base Price Per Incentive Unit Outstanding |
||||||||||||
December 31, 2015 |
- | - | - | $ | - | |||||||||||
December 31, 2016 |
1,934,716 | - | 1,934,716 | $ | 0.54 | |||||||||||
September 30, 2017 |
2,365,950 | 360,294 | 2,005,656 | $ | 1.43 |
For the years ended December 31, 2015 and 2016 and the nine months ended September 30, 2016, there was no intrinsic value of vested incentive units as no incentive units had vested. As of September 30, 2017, the intrinsic value of vested incentive units was $5.2 million.
For the years ended December 31, 2015 and 2016 and the nine months ended September 30, 2016 and 2017, the weighted average grant-date fair value per incentive unit was $0, $0.25, $0.25 and $6.03, respectively. The Company estimated the fair value of each incentive unit grant on the grant date using the Black-Scholes option-pricing model with the following assumptions:
Year Ended
December 31, |
Nine Months Ended
September 30, |
|||||||||||||||
2015 | 2016 | 2016 | 2017 | |||||||||||||
(unaudited) | ||||||||||||||||
Expected volatility |
- | 78%-79% | - | 73-76% | ||||||||||||
Expected life |
- | 6-10 years | - | 6-10 years | ||||||||||||
Risk-free interest rate |
- | 1.3%-2.5% | - | 2.0%-2.3% | ||||||||||||
Expected dividend yield |
- | 0% | - | 0% |
F-14
ODONATE THERAPEUTICS, LLC
Notes to Financial Statements
Expected Volatility. Due to the Companys lack of a public market for the trading of its common units and lack of Company-specific historical or implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies in the life sciences industry the shares of which are publicly traded. The Company selected the peer group based on comparable characteristics, including development stage, product pipeline and enterprise value. The Company computed historical volatility data using the daily closing prices for the selected companies shares during the equivalent period of the calculated expected term of the equity-based awards. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own unit price becomes available.
Expected Life. The expected life represents the period that the incentive units were expected to be outstanding. It is based on the simplified method for developing the estimate of the expected life. Under this approach, the expected life is presumed to be the midpoint between the average vesting date and the end of the contractual term.
Risk-free Interest Rate. The Company bases the risk-free interest rate assumption on U.S. Treasury constant maturities with maturities similar to those of the expected term of the incentive unit being valued.
Expected Dividend Yield. The Company bases the expected dividend yield assumption on the fact that it has never paid, and does not expect to pay, dividends in the foreseeable future.
In addition to assumptions used in the Black-Scholes option-pricing model, the Company estimates a forfeiture rate to calculate the equity-based compensation expense for incentive units. The forfeiture rate is based on an analysis of actual and estimated forfeitures.
The classification of equity-based compensation expense is summarized as follows (in thousands):
Year Ended
December 31, |
Nine Months Ended
September 30, |
|||||||||||||||
2015 | 2016 | 2016 | 2017 | |||||||||||||
(unaudited) | ||||||||||||||||
Equity-based compensation expense: |
||||||||||||||||
Research and development |
$ | - | $ | 51 | $ | 24 | $ | 2,066 | ||||||||
General and administrative |
- | - | - | 132 | ||||||||||||
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Total equity-based compensation expense |
$ | - | $ | 51 | $ | 24 | $ | 2,198 |
As of December 31, 2016, total compensation cost related to non-vested incentive units was $0.4 million, which will be recognized over a weighted average period of 3.7 years. As of September 30, 2017 total compensation cost related to unvested incentive units was $6.5 million, which will be recognized over a weighted average period of 3.3 years.
6. License Agreement
In 2013, the Company licensed rights to tesetaxel in all major markets from Daiichi Sankyo Company, Limited (Daiichi Sankyo), the original inventor of the product. Under the Daiichi Sankyo license agreement, the Company is obligated to use commercially reasonable efforts to develop and commercialize tesetaxel in the following countries: France, Germany, Italy, Spain, the United Kingdom
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ODONATE THERAPEUTICS, LLC
Notes to Financial Statements
and the U.S. The Company is required to make aggregate future milestone payments of up to $31.0 million, contingent on attainment of certain regulatory milestones. Additionally, the Company will pay Daiichi Sankyo a tiered royalty that ranges from the low to high single digits, depending on annual net sales of tesetaxel.
7. Related Party Transactions
Commencing in 2016, the Company received certain services and other benefits from an affiliate (the Affiliate) of the Chairman and Chief Executive Officer of the Company. The Company was not charged any fees for these services and other benefits, which included personnel costs for research and development and administrative functions, rent and facility costs, and other direct expenses. For the years ended December 31, 2015 and 2016 and the nine months ended September 30, 2016 and 2017, the Company recorded expenses of $0, $1.0 million, $0.4 million and $1.7 million, respectively, for services and other benefits provided without charge to the Company, which amounts were recorded as corresponding increases to non-cash contributed capital. Personnel costs were based on actual costs incurred by the Affiliate, which were allocated based on the estimated percentage of time employees spent on Odonate on an employee-by-employee basis. Rent and facility costs were based on actual costs incurred by the Affiliate and allocated based on the Companys use of shared space based on headcount. Other direct expenses paid by the Affiliate were specifically identifiable to the Company and were allocated directly to the Company. The Chairman and Chief Executive Officer of the Company has elected to receive an annual salary of $1.00 and to not receive any bonuses, equity or other compensation.
Management believes that the method used to allocate costs is a fair and reasonable reflection of the utilization of the services provided to, or the benefit received by, the Company during the periods presented. The allocations may not, however, reflect the expense that the Company would have incurred without these services for the periods presented. Actual costs that may have been incurred if the Company had not received these services would depend on a number of factors, including strategic decisions in the areas of hiring, facility location and whether to or not to outsource certain functions.
8. 401(k) Plan
During 2016, the Company adopted a defined contribution 401(k) plan available to eligible employees. Employee contributions are voluntary and are determined on an individual basis, limited to the maximum amount allowable under U.S. federal tax regulations. The Company makes a mandatory annual contribution of 3% of the eligible employees compensation to the 401(k) plan. In addition, the Company makes matching contributions of up to 6% of the eligible employees compensation to the 401(k) plan. For the year ended December 31, 2016 and for the nine months ended September 30, 2016 and 2017, the Company incurred costs of $12,000, $0 and $0.1 million, respectively, related to the 401(k) plan.
9. Subsequent Events
The Company has completed an evaluation of all subsequent events through November 27, 2017 to ensure that this filing includes appropriate disclosure of events both recognized in the September 30, 2017 financial statements and events that occurred but were not recognized in the financial statements. Except as described below, the Company has concluded that no subsequent event has occurred that requires disclosure.
F-16
ODONATE THERAPEUTICS, LLC
Notes to Financial Statements
From October 1, 2017 through November 27, 2017, 639,568 incentive units were granted to employees, and 74,116 incentive units were forfeited.
On November 26, 2017, the Company implemented an amendment to the Companys operating agreement to effect a 2-for-1 forward split of the Companys outstanding common units and incentive units. All outstanding units have been retroactively adjusted to reflect this split for all periods presented.
F-17
5,880,000 Shares
Odonate Therapeutics, Inc.
Common Stock
Goldman Sachs & Co. LLC
Jefferies
Cowen
Through and including , 2017 (the 25th day after the date of this prospectus), all dealers effecting transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to a dealers obligation to deliver a prospectus when acting as an underwriter and with respect to an unsold allotment or subscription.
PART II
INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item 13. Other Expenses of Issuance and Distribution.
The following table sets forth the various expenses, other than underwriting discounts and commissions, payable by the registrant in connection with the sale of common stock being registered. All of the amounts shown are estimated except the Securities and Exchange Commission registration fee and the FINRA filing fee.
Amount
To Be Paid |
||||
SEC registration fee |
$ | 22,731 | ||
FINRA filing fee |
27,886 | |||
NASDAQ listing fee |
125,000 | |||
Printing and engraving expenses |
400,000 | |||
Legal fees and expenses |
1,480,000 | |||
Accounting fees and expenses |
200,000 | |||
Transfer agent and registrar fees |
10,000 | |||
Miscellaneous fees and expenses |
78,583 | |||
|
|
|||
Total |
$ | 2,344,200 | ||
|
|
Item 14. Indemnification of Directors and Officers.
The Company is currently a Delaware limited liability company. As part of the Conversion described in the prospectus contained in this registration statement, the Company will become a Delaware corporation. Section 145(a) of the Delaware General Corporation Law (the DGCL) provides that a Delaware corporation may indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative, other than an action by or in the right of the corporation, by reason of the fact that such person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorneys fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by the person in connection with such action, suit or proceeding if the person acted in good faith and in a manner the person reasonably believed to be in or not opposed to the best interests of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful.
Section 145(b) of the DGCL provides that a Delaware corporation may indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action or suit by or in the right of the corporation to procure a judgment in its favor by reason of the fact that such person acted in any of the capacities set forth above, against expenses (including attorneys fees) actually and reasonably incurred by such person in connection with the defense or settlement of such action or suit if the person acted in good faith and in a manner the person reasonably believed to be in, or not opposed to, the best interests of the corporation, except that no indemnification shall be made in respect of any claim, issue or matter as to which such person shall have been adjudged to be liable to the corporation, unless and only to the extent that the Court of Chancery or the court in which such action or suit was brought shall determine that, despite the adjudication of liability but in view of all the
II-1
circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which the court shall deem proper.
Further subsections of DGCL Section 145 provide that:
(1) | to the extent a present or former director or officer of a corporation has been successful on the merits or otherwise in the defense of any action, suit or proceeding referred to in subsections (i) and (ii) of Section 145 or in the defense of any claim, issue or matter therein, such person shall be indemnified against expenses, including attorneys fees, actually and reasonably incurred by such person in connection therewith; |
(2) | the indemnification and advancement of expenses provided for pursuant to Section 145 shall not be deemed exclusive of any other rights to which those seeking indemnification or advancement of expenses may be entitled under any bylaw, agreement, vote of stockholders or disinterested directors or otherwise; and |
(3) | the corporation shall have the power to purchase and maintain insurance of behalf of any person who is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against any liability asserted against such person and incurred by such person in any such capacity, or arising out of such persons status as such, whether or not the corporation would have the power to indemnify such person against such liability under Section 145. |
As used in this Item 14, the term proceeding means any threatened, pending or completed action, suit or proceeding, whether or not by or in the right of the Company, and whether civil, criminal, administrative, investigative or otherwise.
Section 145 of the DGCL makes provision for the indemnification of officers and directors in terms sufficiently broad to indemnify officers and directors of the Company under certain circumstances from liabilities (including reimbursement for expenses incurred) arising under the Securities Act of 1933. The Companys organizational documents provide, in effect, that, to the fullest extent and under the circumstances permitted by Section 145 of the DGCL, the Company will indemnify any and all of its officers and directors. Before the completion of this offering, the Company intends to enter into indemnification agreements with its officers and directors. The Company may, in its discretion, similarly indemnify its employees and agents. The Companys certificate of incorporation also relieves its directors from monetary damages to the Company or its stockholders for breach of such directors fiduciary duty as a director to the fullest extent permitted by the DGCL. Under Section 102(b)(7) of the DGCL, a corporation may relieve its directors from personal liability to such corporation or its stockholders for monetary damages for any breach of their fiduciary duty as directors except (i) for a breach of the duty of loyalty, (ii) for failure to act in good faith, (iii) for intentional misconduct or knowing violation of law, (iv) for willful or negligent violations of certain provisions in the DGCL imposing certain requirements with respect to stock repurchases, redemptions and dividends or (v) for any transactions from which the director derived an improper personal benefit.
The Company has purchased insurance policies that, within the limits and subject to the terms and conditions thereof, cover certain expenses and liabilities that may be incurred by directors and officers in connection with proceedings that may be brought against them as a result of an act or omission committed or suffered while acting as a director or officer of the Company.
The form of Underwriting Agreement, to be entered into in connection with this offering and attached as Exhibit 1.1 hereto, provides for the indemnification by the underwriters of us and our officers and directors for certain liabilities, including liabilities arising under the Securities Act, and affords certain rights of contribution with respect thereto.
II-2
Item 15. Recent Sales of Unregistered Securities.
Since January 1, 2014, we have made the following sales of unregistered securities.
In June 2016, the Company raised $5.0 million in cash through the sale of 9,283,762 common shares at $0.54 per common share to selected accredited and institutional investors on a post-Conversion basis.
In March 2017, the Company raised $10.0 million in cash through the sale of 2,593,024 common shares at $3.86 per common share to selected accredited and institutional investors on a post-Conversion basis.
In September 2017, the Company raised $74.0 million through the sale of 4,968,132 common shares at $14.90 per common share to selected accredited and institutional investors on a post-Conversion basis.
The offer and sale of all securities listed in this Item 15 was made to a limited number of accredited investors and qualified institutional buyers in reliance upon exemptions from the registration requirements pursuant to Section 4(a)(2) under the Securities Act and Regulation D promulgated under the Securities Act.
Item 16. Exhibits and Financial Statement Schedules.
(a) Exhibits
+ | Indicates a management contract or compensatory plan or arrangement |
# | Confidential treatment requested for portions of this exhibit |
* | Previously filed |
II-3
(b) No financial statement schedules are provided because the information called for is not required or is shown in the financial statements or the notes thereto.
Item 17. Undertakings.
(a) The undersigned registrant hereby undertakes to provide to the underwriters at the closing specified in the underwriting agreements certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.
(b) Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
(c) The undersigned Registrant hereby undertakes that:
(1) | For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance on Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be a part of this registration statement as of the time it was declared effective. |
(2) | For purposes of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
II-4
Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant has duly caused this Amendment No. 1 to Registration Statement on Form S-1 to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of San Diego, State of California, on November 27, 2017.
Odonate Therapeutics, LLC | ||
By: |
/s/ Kevin C. Tang |
|
Kevin C. Tang Chairman and Chief Executive Officer |
Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities set forth opposite their names and on the date indicated above.
Signature |
Title |
Date |
||
/s/ Kevin C. Tang Kevin C. Tang |
Chairman and Chief Executive Officer ( principal executive officer ) |
November 27, 2017 | ||
/s/ John G. Lemkey John G. Lemkey |
Chief Financial Officer ( principal financial and accounting officer ) |
November 27, 2017 | ||
* Jeff L. Vacirca, M.D. |
Director, Vice Chairman |
November 27, 2017 | ||
* Aaron I. Davis |
Director |
November 27, 2017 | ||
* Craig A. Johnson |
Director |
November 27, 2017 | ||
* Robert H. Rosen |
Director |
November 27, 2017 | ||
* George F. Tidmarsh, M.D., Ph.D. |
Director |
November 27, 2017 |
*By: |
/s/ John G. Lemkey |
|
John G. Lemkey Attorney-in-fact |
II-5
Exhibit 1.1
Odonate Therapeutics, Inc.
Common Stock, par value $0.01 per share
Underwriting Agreement
, 2017
Goldman Sachs & Co. LLC,
Jefferies LLC
As representatives (the Representatives) of the several Underwriters
named in Schedule I hereto,
c/o Goldman Sachs & Co. LLC
200 West Street
New York, New York 10282-2198
c/o Jefferies LLC
520 Madison Avenue
New York, New York 10022
Ladies and Gentlemen:
Odonate Therapeutics, Inc., a Delaware corporation (the Company), proposes, subject to the terms and conditions stated in this agreement (this Agreement), to issue and sell to the Underwriters named in Schedule I hereto (the Underwriters) an aggregate of [ 🌑 ] shares (the Firm Shares) and, at the election of the Underwriters, up to [ 🌑 ] additional shares (the Optional Shares) of common stock, par value $0.01 per share (Stock), of the Company. The Firm Shares and the Optional Shares that the Underwriters elect to purchase pursuant to Section 2 hereof being collectively called the Shares.
1. The Company represents and warrants to, and agrees with, each of the Underwriters that:
(a) A registration statement on Form S-1 (File No. 333-221533) (the Initial Registration Statement) in respect of the Shares has been filed with the Securities and Exchange Commission (the Commission); the Initial Registration Statement and any post-effective amendment thereto, each in the form heretofore delivered to you, have been declared effective by the Commission in such form; other than a registration statement, if any, increasing the size of the offering (a Rule 462(b) Registration Statement), filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended (the Act), which became effective upon filing, no other
document with respect to the Initial Registration Statement has been filed with the Commission; and no stop order suspending the effectiveness of the Initial Registration Statement, any post-effective amendment thereto or the Rule 462(b) Registration Statement, if any, has been issued and no proceeding for that purpose has been initiated or threatened by the Commission (any preliminary prospectus included in the Initial Registration Statement or filed with the Commission pursuant to Rule 424(a) of the rules and regulations of the Commission under the Act is hereinafter called a Preliminary Prospectus; the various parts of the Initial Registration Statement and the Rule 462(b) Registration Statement, if any, including all exhibits thereto and including the information contained in the form of final prospectus filed with the Commission pursuant to Rule 424(b) under the Act in accordance with Section 5(a) hereof and deemed by virtue of Rule 430A under the Act to be part of the Initial Registration Statement at the time it was declared effective, each as amended at the time such part of the Initial Registration Statement became effective or such part of the Rule 462(b) Registration Statement, if any, became or hereafter becomes effective, are hereinafter collectively called the Registration Statement; the Preliminary Prospectus relating to the Shares that was included in the Registration Statement immediately prior to the Applicable Time (as defined in Section 1(c) hereof) is hereinafter called the Pricing Prospectus; such final prospectus, in the form first filed pursuant to Rule 424(b) under the Act, is hereinafter called the Prospectus; any oral or written communication with potential investors undertaken in reliance on Section 5(d) of the Act is hereinafter called a Section 5(d) Communication; and any Section 5(d) Communication that is a written communication within the meaning of Rule 405 under the Act is hereinafter called a Section 5(d) Writing; and any issuer free writing prospectus as defined in Rule 433 under the Act relating to the Shares is hereinafter called an Issuer Free Writing Prospectus);
(b) (A) No order preventing or suspending the use of any Preliminary Prospectus or any Issuer Free Writing Prospectus has been issued by the Commission, and (B) each Preliminary Prospectus, at the time of filing thereof, conformed in all material respects to the requirements of the Act and the rules and regulations of the Commission thereunder, and did not contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading; provided , however , that this representation and warranty shall not apply to any statements or omissions made in reliance upon and in conformity with the Underwriter Information (as defined in Section 9(b) of this Agreement);
(c) For the purposes of this Agreement, the Applicable Time is [ 🌑 ]:[ 🌑 ] [a/p].m. (Eastern time) on the date of this Agreement. The Pricing Prospectus, as supplemented by the information listed on Schedule II(c) hereto, taken together (collectively, the Pricing Disclosure Package), as of the Applicable Time, did not, and as of each Time of Delivery (as defined in Section 4(a) of this Agreement) will not, include any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading; and each Issuer Free Writing Prospectus and each Section 5(d) Writing does not conflict with the information contained in the Registration Statement, the Pricing Prospectus or the Prospectus and each Issuer Free Writing Prospectus and each Section 5(d) Writing, as supplemented by and taken together with the Pricing Disclosure Package, as of the Applicable Time, did not, and as of each Time of Delivery will not,
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include any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading; provided, however, that this representation and warranty shall not apply to statements or omissions made in reliance upon and in conformity with the Underwriter Information;
(d) The Registration Statement conforms, and the Prospectus and any further amendments or supplements to the Registration Statement and the Prospectus will conform, in all material respects to the requirements of the Act and the rules and regulations of the Commission thereunder and do not and will not, as of the applicable effective date as to each part of the Registration Statement, as of the applicable filing date as to the Prospectus and any amendment or supplement thereto, and as of each Time of Delivery, contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading; provided, however, that this representation and warranty shall not apply to any statements or omissions made in reliance upon and in conformity with the Underwriter Information;
(e) The Company has not, since the date of the latest audited financial statements included in the Pricing Prospectus, (i) sustained any material loss or interference with its business from fire, explosion, flood or other calamity, whether or not covered by insurance, or from any labor dispute or court or governmental action, order or decree or (ii) entered into any transaction or agreement (whether or not in the ordinary course of business) that is material to the Company or incurred any liability or obligation, direct or contingent, that is material to the Company, in each case otherwise than as set forth or contemplated in the Pricing Prospectus; and, since the respective dates as of which information is given in the Registration Statement and the Pricing Prospectus, there has not been (x) any change in the capital stock (other than as a result of (i) the exercise, if any, of stock options or the award, if any, of stock options or restricted stock in the ordinary course of business pursuant to the Companys equity plans that are described in the Pricing Prospectus and the Prospectus or (ii) the issuance, if any, of stock upon conversion of Company securities as described in the Pricing Prospectus and the Prospectus) or long-term debt of the Company or (y) any Material Adverse Effect (as defined below); as used in this Agreement, Material Adverse Effect shall mean any material adverse change or effect, or any development involving a prospective material adverse change or effect, in or affecting the business, general affairs, management, financial position, stockholders equity or results of operations of the Company, except as set forth or contemplated in the Pricing Prospectus;
(f) The Company does not own any real property. The Company has good and marketable title to all personal property owned by it, in each case free and clear of all liens, encumbrances and defects except such as are described in the Pricing Prospectus or such as do not materially affect the value of such property and do not interfere with the use made and proposed to be made of such property by the Company; and any real property and buildings held under lease by the Company are, to the Companys knowledge, held by the Company under valid, subsisting and enforceable leases with such exceptions as are not material and do not interfere with the use made and proposed to be made of such property and buildings by the Company;
(g) The Company has been (i) duly incorporated and is validly existing and in good standing under the laws of the State of Delaware, with power and authority (corporate and other)
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to own and/or lease its properties and conduct its business as described in the Pricing Prospectus, and (ii) duly qualified as a foreign corporation for the transaction of business and is in good standing under the laws of each other jurisdiction in which it owns or leases properties or conducts any business so as to require such qualification, except where the failure to be so qualified or in good standing would not, individually or in the aggregate, have a Material Adverse Effect. The conversion of the Company from a Delaware limited liability company (the Predecessor LLC) into a Delaware corporation and the conversion of all outstanding membership interests in the Predecessor LLC into shares of Stock were duly authorized by the Predecessor LLC;
(h) The Company has an authorized capitalization as set forth in the Pricing Prospectus and all of the issued shares of capital stock of the Company have been duly and validly authorized and issued and are fully paid and non-assessable and conform to the description of the Stock contained in the Pricing Disclosure Package and Prospectus;
(i) The Shares have been duly and validly authorized and, when issued and delivered against payment therefor as provided herein, will be duly and validly issued and fully paid and non-assessable and will conform to the description of the Stock contained in the Pricing Disclosure Package and the Prospectus; and the issuance of the Shares is not subject to any preemptive or similar rights that have not been complied with or otherwise effectively waived;
(j) The issue and sale of the Shares, the compliance by the Company with this Agreement and the consummation by the Company of the transactions contemplated in this Agreement and the Pricing Prospectus will not conflict with or result in a breach or violation of any of the terms or provisions of, or constitute a default under, (A) any indenture, mortgage, deed of trust, loan agreement or other agreement or instrument to which the Company is a party or by which the Company is bound or to which any of the property or assets of the Company is subject, (B) the certificate of incorporation and bylaws of the Company, or (C) any statute or any judgment, order, rule or regulation of any court or governmental agency or body having jurisdiction over the Company or any of its properties, except, in the case of clause (A) or (C), for such defaults, breaches or violations that would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; and no consent, approval, authorization, order, registration or qualification of or with any such court or governmental agency or body is required for the issue and sale of the Shares or the consummation by the Company of the transactions contemplated by this Agreement, except such as have been obtained under the Act and such consents, approvals, authorizations, registrations or qualifications as may be required under state securities or Blue Sky laws in connection with the purchase and distribution of the Shares by the Underwriters;
(k) The Company is not (i) in violation of its certificate of incorporation, bylaws or equivalent organizational documents, (ii) in violation of any statute or any judgment, order, rule or regulation of any court or governmental agency or body having jurisdiction over the Company or any of its properties, or (iii) in default in the performance or observance of any material obligation, agreement, covenant or condition contained in any indenture, mortgage, deed of trust, loan agreement, lease or other agreement or instrument to which it is a party or by which it or any of its properties may be bound, except, in the case of the foregoing clauses (ii) and (iii), for such
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violations or defaults as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect;
(l) The statements set forth in (i) the Pricing Prospectus and Prospectus under the caption Description of Capital Stock, insofar as they purport to constitute a summary of the terms of the Stock, and (ii) the Pricing Prospectus and Prospectus under the captions BusinessGovernment Regulation, BusinessPatents and Proprietary Rights, Risk FactorsRisks Relating to Intellectual Property, Risk FactorsRisks Related to Our Industry, Material U.S. Federal Income Tax Consequences to Non-U.S. Holders, and Underwriting, insofar as they purport to describe the provisions of the laws and documents referred to therein, are accurate, complete and fair in all material respects;
(m) Other than as set forth in the Pricing Prospectus, there are no legal or governmental proceedings pending to which the Company is a party or of which any property of the Company is the subject which, if determined adversely to the Company, would individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; and, to the Companys knowledge, no such proceedings are threatened or contemplated by governmental authorities or others;
(n) The Company is not and, after giving effect to the offering and sale of the Shares and the application of the proceeds thereof, will not be an investment company, as such term is defined in the Investment Company Act of 1940, as amended (the Investment Company Act);
(o) At the time of filing the Initial Registration Statement the Company was not, and as of the date hereof is not, an ineligible issuer, as defined under Rule 405 under the Act;
(p) Squar Milner LLP, who has certified certain financial statements of the Company, is an independent registered public accounting firm, as required by the Act and the rules and regulations of the Commission thereunder;
(q) The Company maintains a system of internal control over financial reporting (as such term is defined in Rule 13a-15(f) under the Securities and Exchange Act of 1934, as amended (the Exchange Act)) that (i) complies with the requirements of the Exchange Act and (ii) has been designed by the Companys principal executive officer and principal financial officer, or under their 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 and (iii) is sufficient to provide reasonable assurance that (A) transactions are executed in accordance with managements general or specific authorization, (B) transactions are recorded as necessary to permit preparation of financial statements in conformity with generally accepted accounting principles and to maintain accountability for assets, (C) access to assets is permitted only in accordance with managements general or specific authorization and (D) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. The Company is not aware of any material weaknesses or significant deficiencies in its internal control over financial reporting (it being understood that this subsection shall not require the Company to comply with Section 404 of the Sarbanes-Oxley Act of 2002 as of an earlier date than it would otherwise be required to so comply under applicable law);
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(r) Since the date of the latest audited financial statements included in the Pricing Prospectus, no material weakness or significant deficiency has been identified in the internal control over financial reporting of the Company, and there has been no change in the Companys internal control over financial reporting that has materially and adversely affected, or is reasonably likely to materially and adversely affect, the Companys internal control over financial reporting;
(s) The Company maintains disclosure controls and procedures (as such term is defined in Rule 13a-15(e) under the Exchange Act) that comply with the requirements of the Exchange Act; such disclosure controls and procedures have been designed to ensure that material information relating to the Company is made known to the Companys principal executive officer and principal financial officer by others within those entities; and such disclosure controls and procedures are effective;
(t) This Agreement has been duly authorized, executed and delivered by the Company;
(u) Neither the Company nor, to the knowledge of the Company, any director, officer, agent, employee, affiliate or other person associated with or acting on behalf of the Company has (i) made, offered, promised or authorized any unlawful contribution, gift, entertainment or other unlawful expense; (ii) made, offered, promised or authorized any direct or indirect unlawful; (iii) violated or is in violation of any provision of the Foreign Corrupt Practices Act of 1977, as amended, the Bribery Act 2010 of the United Kingdom or any other applicable anti-bribery or anti-corruption law;
(v) The operations of the Company are and have been conducted at all times in compliance with the requirements of applicable anti-money laundering laws, including, but not limited to, the Bank Secrecy Act of 1970, as amended by the USA PATRIOT ACT of 2001, and the rules and regulations promulgated thereunder, and the anti-money laundering laws of the various jurisdictions in which the Company conducts business (collectively, the Money Laundering Laws) and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company with respect to the Money Laundering Laws is pending or, to the knowledge of the Company, threatened;
(w) Neither the Company nor, to the knowledge of the Company, any director, officer, agent, employee or affiliate of the Company is currently the subject or the target of any sanctions administered or enforced by the U.S. Government, including, without limitation, the Office of Foreign Assets Control of the U.S. Department of the Treasury (OFAC), or the U.S. Department of State and including, without limitation, the designation as a specially designated national or blocked person, the European Union, Her Majestys Treasury, the United Nations Security Council, or other relevant sanctions authority (collectively, Sanctions), and the Company will not directly or indirectly use the proceeds of the offering of the Shares hereunder, or lend, contribute or otherwise make available such proceeds to any subsidiary, joint venture partner or other person or entity (i) to fund or facilitate any activities of or business with any person, or in any country or territory, that, at the time of such funding, is the subject or the target of Sanctions or (ii) in any other manner that will result in a violation by any person (including any
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person participating in the transaction, whether as underwriter, advisor, investor or otherwise) of Sanctions. For the past five years, the Company has not knowingly engaged in and are not now knowingly engaged in any dealings or transactions with any person that at the time of the dealing or transaction is or was the subject or the target of Sanctions or with any country or territory that is the subject or target of Sanctions;
(x) From the time of initial confidential submission of a registration statement relating to the Shares with the Commission (or, if earlier, the first date on which a Section 5(d) Communication was made) through the date hereof, the Company has been and is an emerging growth company as defined in Section 2(a)(19) of the Act (an Emerging Growth Company);
(y) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company owns, or has valid, binding and enforceable licenses for, or other rights to use on reasonable terms, the patents and patent applications, copyrights, trademarks, trademark registrations, service marks, service mark registrations, trade names, service names and know-how (including trade secrets and other unpatented and/or unpatentable proprietary or confidential information, systems or procedures) used in the conduct of, or necessary for the proposed conduct of, the business of the Company in the manner described in the Registration Statement, the Pricing Disclosure Package and the Prospectus (collectively, the Company Intellectual Property). To the Companys knowledge, the Company has complied with the terms of each license agreement described in the Registration Statement, the Pricing Disclosure Package and/or the Prospectus pursuant to which Company Intellectual Property rights have been licensed to the Company, except where the failure to comply would not be expected, singly or in the aggregate, to result in a Material Adverse Effect. In particular, the Company is and has been in compliance with the terms and provisions of that certain agreement between the Company and Daiichi Sankyo Company, Limited (Daiichi) dated June 3, 2013 (Daiichi Agreement), the Company is not aware of any facts that it believes would allow or cause Daiichi to form a reasonable basis for a claim of breach by the Company of any terms or provisions under the Daiichi Agreement, and the issue and sale of the Shares and the consummation of the transactions herein contemplated will not conflict with or result in a breach or violation of any of the terms or provisions of the Daiichi Agreement. Each license agreement described in the Registration Statement, Disclosure Package and/or the Prospectus pursuant to which Company Intellectual Property have been licensed to the Company remains in full force and effect. The Company has taken reasonable steps to protect, maintain and safeguard its rights and licenses under Intellectual Property owned by or licensed to the Company, including the execution of appropriate nondisclosure and confidentiality agreements.
Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, to the knowledge of the Company, the patents, trademarks, and copyrights included within the Company Intellectual Property are valid, enforceable, and subsisting, and there is no pending or, to the Companys knowledge, threatened action, suit, proceeding or claim by others challenging the validity, enforceability or scope of any Company Intellectual Property and the Company is unaware of any facts which would form a reasonable basis for such claim; other than as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, (i) there is no pending or threatened action, suit, proceeding or claim by others that the Company infringes, misappropriates or otherwise violates, or would, upon the commercialization of any
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product or service described in the Registration Statement, the Pricing Disclosure Package or the Prospectus, infringe or otherwise misappropriate or violate any rights of others with respect to any of the Companys products, proposed products, processes and the Company has not received any notice of any such claim of infringement, misappropriation or violation; (ii) to the knowledge of the Company, neither the sale nor use of any of products, proposed products or processes of the Company referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus do or will, infringe, interfere or conflict with any copyright, trademark or patent claim of any third party, and (iii) to the knowledge of the Company, no third party has any ownership right in or to any Company Intellectual Property that is owned by the Company, and, to the knowledge of the Company, no third party has any ownership right in or to any Company Intellectual Property in any field of use that is exclusively licensed to the Company, other than any licensor to the Company of such Company Intellectual Property and (iv) to the knowledge of the Company, none of the technology employed by the Company has been obtained or is being used by the Company in violation of any contractual obligation binding on the Company or upon any of its officers, directors or employees, and the Company is not aware of any facts that it believes would form a reasonable basis for a successful challenge that any of its employees are in or have ever been in violation of any term of any employment contract, patent disclosure agreement, invention assignment agreement, non-competition agreement, non-solicitation agreement, nondisclosure agreement or any restrictive covenant to or with a former employer where such violation relates to such employees breach of a confidentiality obligation, obligation to assign to the Company Intellectual Property, or obligation not to use third party intellectual property or other proprietary rights on behalf of the Company. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, all patents and patent applications owned by, and, to the knowledge of the Company, all patent and patent applications licensed to the Company or under which the Company has rights have, been duly and properly filed and maintained; to the knowledge of the Company, the parties prosecuting such applications have complied with their duty of candor and disclosure to the U.S. Patent and Trademark Office (the USPTO) in connection with such applications; and the Company is not aware of any facts required to be disclosed to the USPTO that were not disclosed to the USPTO and which would preclude the grant of a patent in connection with any such application or could form the basis of a finding of invalidity with respect to any patents that have issued with respect to such applications.
(z) The financial statements, including the notes thereto, and the supporting schedules included in the Registration Statement, the Pricing Prospectus and the Prospectus present fairly in all material respects the financial position at the dates indicated therein and the cash flows and results of operations for the periods indicated therein of the Company; except as otherwise stated in the Registration Statement, the Pricing Prospectus and the Prospectus, such financial statements have been prepared in conformity with GAAP applied on a consistent basis throughout the periods involved; and the supporting schedules, if any, included in the Registration Statement, the Pricing Prospectus and the Prospectus present fairly in all material respects the information required to be stated therein. The selected financial data and the summary financial information set forth in the Registration Statement, the Pricing Prospectus and the Prospectus present fairly in all material respects the information included therein and have been prepared on a basis consistent with that of the financial statements that are included in the Registration Statement, the Pricing
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Prospectus and the Prospectus and the books and records of the Company. No other financial statements or supporting schedules are required to be included in the Registration Statement. All disclosures contained in the Registration Statement, the Pricing Prospectus and the Prospectus regarding non-GAAP financial measures (as such term is defined by the rules and regulations of the Commission) comply with Regulation G of the Exchange Act and Item 10 of Regulation S-K of the Act, to the extent applicable;
(aa) Except as described in the Pricing Prospectus and the Prospectus, there are no contracts, agreements or understandings between the Company and any person that would give rise to a valid claim against the Company or any Underwriter for a brokerage commission, finders fee or other like payment in connection with this offering;
(bb) Except as described in the Pricing Prospectus and the Prospectus, there are no contracts, agreements or understandings between the Company and any person granting such person the right to require the Company to file a registration statement under the Act with respect to any securities of the Company owned or to be owned by such person or to require the Company to include such securities in the securities registered pursuant to the Registration Statement or in any securities being registered pursuant to any other registration statement filed by the Company under the Act;
(cc) The Company has not and, to its knowledge, no one acting on its behalf has, taken and will not take, directly or indirectly, any action which is designed to or which has constituted or which would reasonably be expected to cause or result in stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of the Shares;
(dd) (A) The Company is not in violation of any applicable statute, law, rule, regulation, ordinance, code, rule of common law or order of or with any governmental agency or body or any court, domestic or foreign, relating to the use, management, disposal or release of hazardous or toxic substances or wastes or relating to pollution or the protection of the environment or human health or relating to exposure to hazardous or toxic substances or wastes (collectively, Environmental Laws) applicable to the Company, and (B) the Company is not aware of any pending or threatened notice, claim, proceeding or investigation which might lead to liability under Environmental Laws, except, in the case of (A) or (B), where the violation or the potential liability or obligation would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect;
(ee) The Company has filed all material foreign, federal, state and local tax returns required to be filed by them through the date hereof, or have duly requested extensions thereof, and have paid all material taxes shown as due thereon, and all such tax returns are true and correct in all material respects. No deficiencies for taxes of the Company have been assessed by a tax authority, and no deficiencies for taxes of the Company have, to the Companys knowledge, been proposed by a tax authority, except for such deficiencies as would not, individually or in the aggregate, reasonably be expected to have a material adverse effect on the Company;
(ff) The Company is insured by insurers of recognized financial responsibility against such losses and risks and in such amounts as are commercially reasonable for the conduct of its business, and the Company has no reason to believe that it will not be able to renew its existing
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insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business;
(gg) No material labor dispute with or disturbance by the employees of the Company exists or, to the Companys knowledge, is threatened, and the Company has not received written notice of any existing, threatened or imminent labor disturbance by the employees of any of its principal suppliers, manufacturers or contractors that, if it occurred, would, individually or in the aggregate, have a material adverse effect on the Company;
(hh) The statistical and market-related data included in the Pricing Prospectus and the Prospectus are based on or derived from sources which the Company believes are reliable and accurate in all material respects;
(ii) Except as described in the Registration Statement, the Pricing Prospectus and the Prospectus, the Company: (A) is and at all times has been in compliance with all statutes, rules or regulations of the U.S. Food and Drug Administration (FDA), including without limitation, the Federal Food, Drug, and Cosmetic Act and regulations promulgated thereunder, and other comparable federal, state, local or foreign governmental and regulatory authorities (Governmental Authority) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (Applicable Laws); (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with any Applicable Laws; (C) possesses all material licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any Applicable Laws (Authorizations), except where the failure to possess such Authorizations would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, and such Authorizations are valid and in full force and effect and the Company is in compliance with the terms of such Authorizations, except where the failure to comply would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (D) has not received notice that the FDA or any Governmental Authority has taken any action to limit, suspend or revoke any material Authorizations; and (E) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority or third party alleging that the Company is in violation of any Applicable Laws or Authorizations, the effect of any such violations would, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect;
(jj) The Company has not had any product manufacturing or testing site (whether Company-owned or contracted) subject to a Governmental Authority (including FDA or other Governmental Authority) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Authority notice of inspectional observations, warning letters, untitled letters, or other enforcement action, except for such correspondence that would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, and the Company has not conducted or issued any recalls, field notifications, field corrections, safety alerts, or other
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notice or action relating to a material lack of safety or regulatory compliance of any Company product;
(kk) The preclinical studies and clinical trials conducted by or on behalf of the Company that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, were and, if still ongoing, are being conducted in all material respects in accordance with their protocols, accepted professional and scientific standards and Applicable Laws; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Companys knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any other preclinical studies or clinical trials, the results of which the Company believes reasonably call into question the results described in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or correspondence from the FDA or any Governmental Authority initiating or threatening to initiate a clinical hold, termination or suspension of any preclinical studies or clinical trials conducted or proposed to be conducted by or on behalf of the Company that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials;
(ll) The Company is, and at all times has been, in compliance in all material respects with all applicable Health Care Laws (defined herein), and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other U.S. state or federal health care program. For purposes of this Agreement, Health Care Laws shall mean the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)); the civil False Claims Act (31 U.S.C. §§ 3729 et seq.); the criminal False Claims Act (42 U.S.C. § 1320a-7b(a)); all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.) (HIPAA); the exclusion laws (42 U.S.C. § 1320a-7); the civil monetary penalties law (42 U.S.C. § 1320a-7a); the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h); HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.); the Medicare statute (Title XVIII of the Social Security Act); the Medicaid statute (Title XIX of the Social Security Act); the regulations promulgated pursuant to such laws and any other similar local, state or federal law and regulations. The Company has not received written notice from any governmental or regulatory authority alleging or asserting noncompliance with any Health Care Law, and, to the Companys knowledge, no claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is not a party to nor has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by
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any governmental or regulatory authority. Neither the Company nor, to the knowledge of the Company, any of its employees, officers, directors or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research, or is subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in debarment, suspension or exclusion;
(mm) The Company has no subsidiaries; and
(nn) The Company does not have any preferred stock that is rated by any nationally recognized statistical rating organization, as that term is defined by the Commission for purposes of Rule 436(g)(2) under the Act.
2. Subject to the terms and conditions herein set forth, (a) the Company agrees to issue and sell to each of the Underwriters, and each of the Underwriters agrees, severally and not jointly, to purchase from the Company, at a purchase price per share of $[ 🌑 ], the number of Firm Shares set forth opposite the name of such Underwriter in Schedule I hereto and (b) in the event and to the extent that the Underwriters shall exercise the election to purchase Optional Shares as provided below, the Company agrees to issue and sell to each of the Underwriters, and each of the Underwriters agrees, severally and not jointly, to purchase from the Company, at the purchase price per share set forth in clause (a) of this Section 2 (provided that the purchase price per Optional Share shall be reduced by an amount per share equal to any dividends or distributions declared by the Company and payable on the Firm Shares but not payable on the Optional Shares), that portion of the number of Optional Shares as to which such election shall have been exercised (to be adjusted by you so as to eliminate fractional shares) determined by multiplying such number of Optional Shares by a fraction, the numerator of which is the maximum number of Optional Shares which such Underwriter is entitled to purchase as set forth opposite the name of such Underwriter in Schedule I hereto and the denominator of which is the maximum number of Optional Shares that all of the Underwriters are entitled to purchase hereunder.
The Company hereby grants to the Underwriters the right to purchase at their election up to [ 🌑 ] Optional Shares, at the purchase price per share set forth in the paragraph above, for the sole purpose of covering sales of shares in excess of the number of Firm Shares, provided that the purchase price per Optional Share shall be reduced by an amount per share equal to any dividends or distributions declared by the Company and payable on the Firm Shares but not payable on the Optional Shares. Any such election to purchase Optional Shares may be exercised only by written notice from you to the Company, given within a period of 30 calendar days after the date of this Agreement, setting forth the aggregate number of Optional Shares to be purchased and the date on which such Optional Shares are to be delivered, as determined by you but in no event earlier than the First Time of Delivery (as defined in Section 4 hereof) or, unless you and the Company otherwise agree in writing, earlier than two or later than ten business days after the date of such notice.
3. Upon the authorization by you of the release of the Firm Shares, the several Underwriters propose to offer the Firm Shares for sale upon the terms and conditions set forth in the Pricing Prospectus and the Prospectus.
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4. (a) The Shares to be purchased by each Underwriter hereunder, in book-entry form, and in such authorized denominations and registered in such names as the Representatives may request upon at least forty-eight hours prior notice to the Company shall be delivered by or on behalf of the Company to Goldman Sachs & Co. LLC, through the facilities of the Depository Trust Company (DTC), for the account of such Underwriter, against payment by or on behalf of such Underwriter of the purchase price therefor by wire transfer of Federal (same-day) funds to the account specified by the Company to the Representatives at least forty-eight hours in advance. The time and date of such delivery and payment shall be, with respect to the Firm Shares, 9:30 a.m., New York City time, on [ 🌑 ], 20[ 🌑 ] or such other time and date as the Representatives and the Company may agree upon in writing, and, with respect to the Optional Shares, 9:30 a.m., New York time, on the date specified by the Representatives in the written notice given by the Representatives of the Underwriters election to purchase such Optional Shares, or such other time and date as the Representatives and the Company may agree upon in writing. Such time and date for delivery of the Firm Shares is herein called the First Time of Delivery, such time and date for delivery of the Optional Shares, if not the First Time of Delivery, is herein called the Second Time of Delivery, and each such time and date for delivery is herein called a Time of Delivery.
(b) The documents to be delivered at each Time of Delivery by or on behalf of the parties hereto pursuant to Section 8 hereof, including the cross receipt for the Shares and any additional documents requested by the Underwriters pursuant to Section 8(j) hereof, will be delivered at the offices of Latham & Watkins LLP, 140 Scott Drive, Menlo Park, California 94025 (the Closing Location), and the Shares will be delivered at the office of DTC or its designated custodian, all at such Time of Delivery. A meeting will be held at the Closing Location at [ 🌑 ] p.m., New York City time, on the New York Business Day next preceding such Time of Delivery, at which meeting the final drafts of the documents to be delivered pursuant to the preceding sentence will be available for review by the parties hereto. For the purposes of this Section 4, New York Business Day shall mean each Monday, Tuesday, Wednesday, Thursday and Friday which is not a day on which banking institutions in New York City are generally authorized or obligated by law or executive order to close.
5. The Company agrees with each of the Underwriters:
(a) To prepare the Prospectus in a form approved by you and to file such Prospectus pursuant to Rule 424(b) under the Act not later than the Commissions close of business on the second business day following the execution and delivery of this Agreement, or, if applicable, such earlier time as may be required by Rule 430A(a)(3) under the Act; to make no further amendment or any supplement to the Registration Statement or the Prospectus prior to the last Time of Delivery which shall be disapproved by you promptly after reasonable notice thereof; to advise you, promptly after it receives notice thereof, of the time when any amendment to the Registration Statement has been filed or becomes effective or any amendment or supplement to the Prospectus has been filed and to furnish you with copies thereof; to file promptly all material required to be filed by the Company with the Commission pursuant to Rule 433(d) under the Act; to advise you, promptly after it receives notice thereof, of the issuance by the Commission of any stop order or of any order preventing or suspending the use of any Preliminary Prospectus or other prospectus in respect of the Shares, of the suspension of the qualification of the Shares for
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offering or sale in any jurisdiction, of the initiation or threatening of any proceeding for any such purpose, or of any request by the Commission for the amending or supplementing of the Registration Statement or the Prospectus or for additional information; and, in the event of the issuance of any stop order or of any order preventing or suspending the use of any Preliminary Prospectus or other prospectus or suspending any such qualification, to promptly use its best efforts to obtain the withdrawal of such order;
(b) Promptly from time to time to take such action as you may reasonably request to qualify the Shares for offering and sale under the securities laws of such jurisdictions as you may request and to comply with such laws so as to permit the continuance of sales and dealings therein in such jurisdictions for as long as may be necessary to complete the distribution of the Shares, provided that in connection therewith the Company shall not be required to qualify as a foreign corporation or to file a general consent to service of process in any jurisdiction;
(c) Prior to 10:00 a.m., New York City time, on the New York Business Day next succeeding the date of this Agreement (or such other time as may be agreed to by the Representatives and the Company) and from time to time, to furnish the Underwriters with written and electronic copies of the Prospectus in New York City in such quantities as you may reasonably request, and, if the delivery of a prospectus (or in lieu thereof, the notice referred to in Rule 173(a) under the Act) is required at any time prior to the expiration of nine months after the time of issue of the Prospectus in connection with the offering or sale of the Shares and if at such time any event shall have occurred as a result of which the Prospectus as then amended or supplemented would include an untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made when such Prospectus (or in lieu thereof, the notice referred to in Rule 173(a) under the Act) is delivered, not misleading, or, if for any other reason it shall be necessary during such same period to amend or supplement the Prospectus in order to comply with the Act, to notify you and upon your request to prepare and furnish without charge to each Underwriter and to any dealer in securities as many written and electronic copies as you may from time to time reasonably request of an amended Prospectus or a supplement to the Prospectus which will correct such statement or omission or effect such compliance; and in case any Underwriter is required to deliver a prospectus (or in lieu thereof, the notice referred to in Rule 173(a) under the Act) in connection with sales of any of the Shares at any time nine months or more after the time of issue of the Prospectus, upon your request but at the expense of such Underwriter, to prepare and deliver to such Underwriter as many written and electronic copies as you may request of an amended or supplemented Prospectus complying with Section 10(a)(3) of the Act;
(d) To make generally available to its security holders as soon as practicable (which may be satisfied by filing with the Commissions Electronic Data Gathering Analysis and Retrieval System (EDGAR)), but in any event not later than sixteen months after the effective date of the Registration Statement (as defined in Rule 158(c) under the Act), an earnings statement of the Company (which need not be audited) complying with Section 11(a) of the Act and the rules and regulations of the Commission thereunder (including, at the option of the Company, Rule 158);
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(e)(1) During the period beginning from the date hereof and continuing to and including the date that is 180 days after the date of the Prospectus (the Lock-Up Period), not to (i) offer, sell, contract to sell, pledge, grant any option to purchase, make any short sale or otherwise transfer or dispose of, directly or indirectly, or file with or confidentially submit to the Commission a registration statement under the Act relating to, any securities of the Company that are substantially similar to the Shares, including but not limited to any options or warrants to purchase shares of Stock or any securities that are convertible into or exchangeable for, or that represent the right to receive, Stock or any such substantially similar securities, or publicly disclose the intention to make any offer, sale, pledge, disposition or filing or (ii) enter into any swap or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of the Stock or any such other securities, whether any such transaction described in clause (i) or (ii) above is to be settled by delivery of Stock or such other securities, in cash or otherwise, without the prior written consent of the Representatives, in their sole discretion; provided, however, that the foregoing restrictions shall not apply to (A) the Shares to be sold hereunder, (B)(1) the issuance by the Company of shares of Stock upon the exercise for cash of an option or warrant, or upon the conversion or exchange of convertible or exchangeable securities, outstanding as of the date of this Agreement, in each case that are described in the Pricing Prospectus, or (2) the issuance by the Company of shares of Stock upon the cashless exercise of an option or warrant, outstanding as of the date of this Agreement and described in the Pricing Prospectus, which would, but for such exercise, otherwise expire during the Lock-Up Period, (C) the issuance by the Company of Stock or other securities convertible into or exercisable for shares of Stock, in each case pursuant to the Companys stock-based compensation plans, provided that such plans are described in the Pricing Prospectus, or (D) the issuance by the Company of Stock or any securities that are convertible into or exchangeable for, or that represent the right to receive, Stock in connection with any bona fide licensing, commercialization, joint venture, technology transfer or development collaboration agreement with an unaffiliated third-party relating to the Companys product candidates and bona fide commercial credit, equipment financing or commercial property lease transactions with an unaffiliated third-party; provided that in the case of clause (D), the aggregate number of shares of Stock that the Company may sell or issue or agree to sell or issue pursuant to clause (D) shall not exceed 5% of the total number of shares of Stock issued and outstanding immediately following the completion of the transactions contemplated by this Agreement; and provided further, that in the case of clauses (B) through (D), the Company shall: (1) cause each recipient of such securities to execute and deliver to the Representatives, on or prior to the issuance of such securities, a lock-up agreement on substantially the same terms as the lock-up arrangements referenced in Section 8(i) hereof for the remainder of the Lock-Up Period, and (2) enter stop transfer instructions with the Companys transfer agent and registrar on such securities, which the Company agrees it will not waive or amend without the prior written consent of each Representative, in their sole discretion;
(e)(2) If Goldman Sachs & Co. LLC and Jefferies LLC, in their sole discretion, agree to release or waive the restrictions set forth in a lock-up letter described in Section 8(i) hereof for an officer or director of the Company and provide the Company with notice of the impending release or waiver at least three business days before the effective date of the release or waiver, the
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Company agrees to announce the impending release or waiver by a press release substantially in the form of Annex II hereto through a major news service at least two business days before the effective date of the release or waiver.
(f) During a period of three years from the effective date of the Registration Statement, so long as the Company is subject to the reporting requirements of either Section 13 or Section 15(d) of the Exchange Act, to furnish to its stockholders as soon as practicable after the end of each fiscal year an annual report (including a balance sheet and statements of income, stockholders equity and cash flows of the Company certified by independent public accountants) and, as soon as practicable after the end of each of the first three quarters of each fiscal year (beginning with the fiscal quarter ending after the effective date of the Registration Statement), to make available to its stockholders consolidated summary financial information of the Company for such quarter in reasonable detail; provided, that no reports, documents or other information needs to be furnished pursuant to this Section 5(f) to the extent they are available on EDGAR;
(g) During a period of three years from the effective date of the Registration Statement, to furnish to you copies of all reports or other communications (financial or other) furnished to stockholders, and to deliver to you (i) as soon as they are available, copies of any reports and financial statements furnished to or filed with the Commission or any national securities exchange on which any class of securities of the Company is listed; and (ii) such additional information concerning the business and financial condition of the Company as you may from time to time reasonably request (such financial statements to be on a consolidated basis to the extent the accounts of the Company are consolidated in reports furnished to its stockholders generally or to the Commission); provided, that no reports, documents or other information needs to be furnished pursuant to this Section 5(g) to the extent they are available on EDGAR;
(h) To use the net proceeds received by it from the sale of the Shares pursuant to this Agreement in the manner specified in the Pricing Prospectus under the caption Use of Proceeds;
(i) To use its best efforts to list for quotation the Shares on the Nasdaq Stock Market (NASDAQ);
(j) To file with the Commission such information on Form 10-Q or Form 10-K as may be required by Rule 463 under the Act;
(k) If the Company elects to rely upon Rule 462(b), the Company shall file a Rule 462(b) Registration Statement with the Commission in compliance with Rule 462(b) by 10:00 p.m., Washington, D.C. time, on the date of this Agreement, and the Company shall at the time of filing either pay to the Commission the filing fee for the Rule 462(b) Registration Statement or give irrevocable instructions for the payment of such fee pursuant to Rule 111(b) under the Act;
(l) Upon request of any Underwriter, to furnish, or cause to be furnished, to such Underwriter an electronic version of the Companys trademarks, servicemarks and corporate logo for use on the website, if any, operated by such Underwriter for the purpose of facilitating the on-line offering of the Shares (the License); provided, however, that the License shall be used solely for the purpose described above, is granted without any fee and may not be assigned or transferred; and
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(m) To promptly notify you if the Company ceases to be an Emerging Growth Company at any time prior to the later of (i) completion of the distribution of the Shares within the meaning of the Act and (ii) the completion of the Lock-Up Period referred to in Section 5(e) hereof.
6. (a) The Company represents and agrees that, without the prior consent of the Representatives, it has not made and will not make any offer relating to the Shares that would constitute a free writing prospectus as defined in Rule 405 under the Act; each Underwriter represents and agrees that, without the prior consent of the Company and the Representatives, it has not made and will not make any offer relating to the Shares that would constitute a free writing prospectus; any such free writing prospectus the use of which has been consented to by the Company and the Representatives is listed on Schedule II(a) or Schedule II(c) hereto;
(b) The Company has complied and will comply with the requirements of Rule 433 under the Act applicable to any Issuer Free Writing Prospectus, including timely filing with the Commission or retention where required and legending; and the Company represents that it has satisfied and agrees that it will satisfy the conditions under Rule 433 under the Act to avoid a requirement to file with the Commission any electronic road show;
(c) The Company agrees that if at any time following issuance of an Issuer Free Writing Prospectus or any Section 5(d) Writing prepared or authorized by it any event occurred or occurs as a result of which such Issuer Free Writing Prospectus or Section 5(d) Writing prepared or authorized by it would conflict with the information in the Registration Statement, the Pricing Prospectus or the Prospectus or would include an untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein, in the light of the circumstances then prevailing, not misleading, the Company will give prompt notice thereof to the Representatives and, if requested by the Representatives, will prepare and furnish without charge to each Underwriter an Issuer Free Writing Prospectus, Section 5(d) Writing or other document which will correct such conflict, statement or omission; provided, however, that this representation and warranty shall not apply to any statements or omissions in an Issuer Free Writing Prospectus or Section 5(d) Writing prepared or authorized by it made in reliance upon and in conformity with the Underwriter Information;
(d) The Company represents and agrees that (i) it has not engaged in, or authorized any other person to engage in, any Section 5(d) Communications, other than Section 5(d) Communications with the prior consent of the Representatives with entities that are qualified institutional buyers as defined in Rule 144A under the Act or institutions that are accredited investors as defined in Rule 501(a) under the Act; and (ii) it has not distributed, or authorized any other person to distribute, any Section 5(d) Writings, other than those distributed with the prior consent of the Representatives that are listed on Schedule II(d) hereto; and the Company reconfirms that the Underwriters have been authorized to act on its behalf in engaging in Section 5(d) Communications; and
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(e) Each Underwriter represents and agrees that any Section 5(d) Communications undertaken by it were with entities that are qualified institutional buyers as defined in Rule 144A under the Act or institutions that are accredited investors as defined in Rule 501(a) under the Act.
7. The Company covenants and agrees with the several Underwriters that the Company will pay or cause to be paid the following: (i) the fees, disbursements and expenses of the Companys counsel and accountants in connection with the registration of the Shares under the Act and all other expenses in connection with the preparation, printing, reproduction and filing of the Registration Statement, any Preliminary Prospectus, any Section 5(d) Writing, any Issuer Free Writing Prospectus and the Prospectus and amendments and supplements thereto and the mailing and delivering of copies thereof to the Underwriters and dealers; (ii) the cost of printing or producing any Agreement among Underwriters, this Agreement, the Blue Sky Memorandum, closing documents (including any compilations thereof) and any other documents in connection with the offering, purchase, sale and delivery of the Shares; (iii) all expenses in connection with the qualification of the Shares for offering and sale under state securities laws as provided in Section 5(b) hereof, including the fees and disbursements of counsel for the Underwriters in connection with such qualification and in connection with the Blue Sky survey; (iv) all fees and expenses in connection with listing the Shares on NASDAQ; (v) the filing fees incident to, and the fees and disbursements of counsel for the Underwriters in connection with, any required review by the Financial Industry Regulatory Authority (FINRA) of the terms of the sale of the Shares; (vi) the cost of preparing stock certificates; (vii) the cost and charges of any transfer agent or registrar; and (viii) all other costs and expenses incident to the performance of its obligations hereunder which are not otherwise specifically provided for in this Section; provided, however, that the amount payable by the Company pursuant to clauses (iii) and (v) and for the fees and disbursements of counsel to the Underwriters described in clauses (iii) and (v) shall not exceed $40,000 in the aggregate. It is understood, however, that, (x) except as provided in this Section, and Sections 9 and 12 hereof, the Underwriters will pay all of their own costs and expenses, including the fees of their counsel, stock transfer taxes on resale of any of the Shares by them, any advertising expenses connected with any offers they may make and all travel and lodging expenses of the Underwriters and their representatives and counsel; and (y) subject to the Companys and Representatives prior written approval of each such expense, the Underwriters and the Company shall each pay 50% of the cost of chartering any aircraft to be used in connection with the road show by the Company and the Underwriters.
8. The obligations of the Underwriters hereunder, as to the Shares to be delivered at each Time of Delivery, shall be subject, in their discretion, to the condition that all representations and warranties and other statements of the Company herein are, at and as of the Applicable Time and such Time of Delivery, true and correct, the condition that the Company shall have performed all of its obligations hereunder theretofore to be performed, and the following additional conditions:
(a) The Prospectus shall have been filed with the Commission pursuant to Rule 424(b) under the Act within the applicable time period prescribed for such filing by the rules and regulations under the Act and in accordance with Section 5(a) hereof; all material required to be filed by the Company pursuant to Rule 433(d) under the Act shall have been filed with the Commission within the applicable time period prescribed for such
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filing by Rule 433; if the Company has elected to rely upon Rule 462(b) under the Act, the Rule 462(b) Registration Statement shall have become effective by 10:00 P.M., Washington, D.C. time, on the date of this Agreement; no stop order suspending the effectiveness of the Registration Statement or any part thereof shall have been issued and no proceeding for that purpose shall have been initiated or threatened by the Commission; no stop order suspending or preventing the use of the Pricing Prospectus, Prospectus or any Issuer Free Writing Prospectus shall have been initiated or threatened by the Commission; and all requests for additional information on the part of the Commission shall have been complied with to your reasonable satisfaction;
(b) Latham & Watkins LLP, counsel for the Underwriters, shall have furnished to you such written opinion or opinions, dated such Time of Delivery, in form and substance reasonably satisfactory to you, and such counsel shall have received such papers and information as they may reasonably request to enable them to pass upon such matters;
(c) (A) Foley Hoag LLP, intellectual property counsel for the Company, shall have furnished to you their written opinion with respect to intellectual property matters, dated such Time of Delivery, in form and substance satisfactory to you, and (B) Gibson Dunn & Crutcher LLP, corporate counsel for the Company, shall have furnished to you their written opinion, dated such Time of Delivery, in form and substance satisfactory to you;
(d) On the date of the Prospectus at a time prior to the execution of this Agreement, at 9:30 a.m., New York City time, on the effective date of any post-effective amendment to the Registration Statement filed subsequent to the date of this Agreement and also at each Time of Delivery, Squar Milner LLP shall have furnished to you a letter or letters, dated the respective dates of delivery thereof, in form and substance satisfactory to you;
(e) (i) The Company shall not have sustained since the date of the latest audited financial statements included in the Pricing Prospectus any loss or interference with its business from fire, explosion, flood or other calamity, whether or not covered by insurance, or from any labor dispute or court or governmental action, order or decree, otherwise than as set forth or contemplated in the Pricing Prospectus, and (ii) since the respective dates as of which information is given in the Pricing Prospectus there shall not have been any change in the capital stock (other than as a result of the exercise of stock options or the award of stock options or restricted stock in the ordinary course of business pursuant to the Companys equity plans that are described in the Pricing Prospectus) or long-term debt of the Company or any change or effect, or any development involving a prospective change or effect, in or affecting the business, properties, general affairs, management, financial position, stockholders equity or results of operations of the Company, except as set forth or contemplated in the Pricing Prospectus and the Prospectus, or (y) the ability of the Company to perform its obligations under this Agreement, including the issuance and sale of the Shares, or to consummate the transactions contemplated in the Pricing Prospectus and the Prospectus, the effect of which, in any such case described in clause (i) or (ii), is in your judgment so material and adverse as to make it impracticable or inadvisable to proceed with the public offering or
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the delivery of the Shares being delivered at such Time of Delivery on the terms and in the manner contemplated in the Pricing Prospectus and the Prospectus;
(f) On or after the Applicable Time (i) no downgrading shall have occurred in the rating accorded the Companys debt securities by any nationally recognized statistical rating organization, as that term is defined by the Commission for purposes of Rule 436(g)(2) under the Act, and (ii) no such organization shall have publicly announced that it has under surveillance or review, with possible negative implications, its rating of any of the Companys debt securities;
(g) On or after the Applicable Time there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange or on NASDAQ; (ii) a suspension or material limitation in trading in the Companys securities on NASDAQ; (iii) a general moratorium on commercial banking activities declared by either Federal or New York State authorities or a material disruption in commercial banking or securities settlement or clearance services in the United States; (iv) the outbreak or escalation of hostilities involving the United States or the declaration by the United States of a national emergency or war; or (v) the occurrence of any other calamity or crisis or any change in financial, political or economic conditions in the United States or elsewhere, if the effect of any such event specified in clause (iv) or (v) in your judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares being delivered at such Time of Delivery on the terms and in the manner contemplated in the Pricing Prospectus and the Prospectus;
(h) The Shares to be sold at such Time of Delivery shall have been duly listed for quotation on NASDAQ;
(i) The Company shall have obtained and delivered to the Underwriters executed copies of an agreement from each member of the Companys board of directors, each executive officer of the Company and substantially all of the holders of the Companys securities, substantially to the effect set forth in Annex I and in form and substance satisfactory to you;
(j) The Company shall have complied with the provisions of Section 5(c) hereof with respect to the furnishing of prospectuses on the New York Business Day next succeeding the date of this Agreement;
(k) The Company shall have furnished or caused to be furnished to you at such Time of Delivery certificates of officers of the Company satisfactory to you as to the accuracy of the representations and warranties of the Company herein at and as of such Time of Delivery, as to the performance by the Company of all of its obligations hereunder to be performed at or prior to such Time of Delivery, as to the matters set forth in subsections (a) and (e) of this section and as to such other matters as you may reasonably request; and
(l) FINRA shall have confirmed that it has not raised any objection with respect to the fairness and reasonableness of the underwriting terms and arrangements relating to the offering of the Shares.
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9. (a) The Company will indemnify and hold harmless each Underwriter against any losses, claims, damages or liabilities, joint or several, to which such Underwriter may become subject, under the Act or otherwise, insofar as such losses, claims, damages or liabilities (or actions in respect thereof) arise out of or are based upon an untrue statement or alleged untrue statement of a material fact contained in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus, or any amendment or supplement thereto, any Issuer Free Writing Prospectus, any roadshow as defined in Rule 433(h) under the Act (a roadshow), or any issuer information filed or required to be filed pursuant to Rule 433(d) under the Act or any Section 5(d) Writing, or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, and will reimburse each Underwriter for any legal or other expenses reasonably incurred by such Underwriter in connection with investigating or defending any such action or claim as such expenses are incurred; provided , however , that the Company shall not be liable in any such case to the extent that any such loss, claim, damage or liability arises out of or is based upon an untrue statement or alleged untrue statement or omission or alleged omission made in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus, or any amendment or supplement thereto, or any Issuer Free Writing Prospectus or any Section 5(d) Writing, in reliance upon and in conformity with the Underwriter Information.
(b) Each Underwriter will indemnify and hold harmless the Company against any losses, claims, damages or liabilities to which the Company may become subject, under the Act or otherwise, insofar as such losses, claims, damages or liabilities (or actions in respect thereof) arise out of or are based upon an untrue statement or alleged untrue statement of a material fact contained in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus, or any amendment or supplement thereto, or any Issuer Free Writing Prospectus, or any roadshow or any Section 5(d) Writing, or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, in each case to the extent, but only to the extent, that such untrue statement or alleged untrue statement or omission or alleged omission was made in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus, or any amendment or supplement thereto, or any Issuer Free Writing Prospectus, or any roadshow or any Section 5(d) Writing, in reliance upon and in conformity with the Underwriter Information; and will reimburse the Company for any legal or other expenses reasonably incurred by the Company in connection with investigating or defending any such action or claim as such expenses are incurred. As used in this Agreement with respect to an Underwriter and an applicable document, Underwriter Information shall mean the written information furnished to the Company by such Underwriter through the Representatives expressly for use therein; it being understood and agreed upon that the only such information furnished by any Underwriter consists of the following information in the Prospectus furnished on behalf of each Underwriter: the concession and reallowance figures appearing in the [fifth] paragraph under the caption Underwriting, and the information contained in the [ninth], [tenth], [fourteenth] and [fifteenth] paragraphs under the caption Underwriting.
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(c) Promptly after receipt by an indemnified party under subsection (a) or (b) above of notice of the commencement of any action, such indemnified party shall, if a claim in respect thereof is to be made against the indemnifying party under such subsection, notify the indemnifying party in writing of the commencement thereof; provided that the failure to notify the indemnifying party shall not relieve it from any liability that it may have under the preceding paragraphs of this Section 9 except to the extent that it has been materially prejudiced (through the forfeiture of substantive rights or defenses) by such failure; and provided further that the failure to notify the indemnifying party shall not relieve it from any liability that it may have to an indemnified party otherwise than under the preceding paragraphs of this Section 9. In case any such action shall be brought against any indemnified party and it shall notify the indemnifying party of the commencement thereof, the indemnifying party shall be entitled to participate therein and, to the extent that it shall wish, jointly with any other indemnifying party similarly notified, to assume the defense thereof, with counsel satisfactory to such indemnified party (who shall not, except with the consent of the indemnified party, be counsel to the indemnifying party), and, after notice from the indemnifying party to such indemnified party of its election so to assume the defense thereof, the indemnifying party shall not be liable to such indemnified party under such subsection for any legal expenses of other counsel or any other expenses, in each case subsequently incurred by such indemnified party, in connection with the defense thereof other than reasonable costs of investigation. No indemnifying party shall, without the written consent of the indemnified party, effect the settlement or compromise of, or consent to the entry of any judgment with respect to, any pending or threatened action or claim in respect of which indemnification or contribution may be sought hereunder (whether or not the indemnified party is an actual or potential party to such action or claim) unless such settlement, compromise or judgment (i) includes an unconditional release of the indemnified party from all liability arising out of such action or claim and (ii) does not include a statement as to or an admission of fault, culpability or a failure to act, by or on behalf of any indemnified party.
(d) If the indemnification provided for in this Section 9 is unavailable to or insufficient to hold harmless an indemnified party under subsection (a) or (b) above in respect of any losses, claims, damages or liabilities (or actions in respect thereof) referred to therein, then each indemnifying party shall contribute to the amount paid or payable by such indemnified party as a result of such losses, claims, damages or liabilities (or actions in respect thereof) in such proportion as is appropriate to reflect the relative benefits received by the Company on the one hand and the Underwriters on the other from the offering of the Shares. If, however, the allocation provided by the immediately preceding sentence is not permitted by applicable law or if the indemnified party failed to give the notice required under subsection (c) above, then each indemnifying party shall contribute to such amount paid or payable by such indemnified party in such proportion as is appropriate to reflect not only such relative benefits but also the relative fault of the Company on the one hand and the Underwriters on the other in connection with the statements or omissions which resulted in such losses, claims, damages or liabilities (or actions in respect thereof), as well as any other relevant equitable considerations. The relative benefits received by the Company on the one hand and the Underwriters on the other shall be deemed to be in the same proportion as the total net proceeds from the offering (before deducting expenses) received by the Company bear to the total underwriting discounts and commissions received by
22
the Underwriters, in each case as set forth in the table on the cover page of the Prospectus. The relative fault shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission or alleged omission to state a material fact relates to information supplied by the Company on the one hand or the Underwriters on the other and the parties relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission. The Company and the Underwriters agree that it would not be just and equitable if contribution pursuant to this subsection (d) were determined by pro rata allocation (even if the Underwriters were treated as one entity for such purpose) or by any other method of allocation which does not take account of the equitable considerations referred to above in this subsection (d). The amount paid or payable by an indemnified party as a result of the losses, claims, damages or liabilities (or actions in respect thereof) referred to above in this subsection (d) shall be deemed to include any legal or other expenses reasonably incurred by such indemnified party in connection with investigating or defending any such action or claim. Notwithstanding the provisions of this subsection (d), no Underwriter shall be required to contribute any amount in excess of the amount by which the total price at which the Shares underwritten by it and distributed to the public were offered to the public exceeds the amount of any damages which such Underwriter has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission. No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation. The Underwriters obligations in this subsection (d) to contribute are several in proportion to their respective underwriting obligations and not joint.
(e) The obligations of the Company under this Section 9 shall be in addition to any liability which the Company may otherwise have and shall extend, upon the same terms and conditions, to each person, if any, who controls any Underwriter within the meaning of the Act and each broker-dealer affiliate of any Underwriter; and the obligations of the Underwriters under this Section 9 shall be in addition to any liability which the respective Underwriters may otherwise have and shall extend, upon the same terms and conditions, to each officer and director of the Company and to each person, if any, who controls the Company within the meaning of the Act.
10. (a) If any Underwriter shall default in its obligation to purchase the Shares which it has agreed to purchase hereunder at a Time of Delivery, you may in your discretion arrange for you or another party or other parties to purchase such Shares on the terms contained herein. If within thirty-six hours after such default by any Underwriter you do not arrange for the purchase of such Shares, then the Company shall be entitled to a further period of thirty-six hours within which to procure another party or other parties satisfactory to you to purchase such Shares on such terms. In the event that, within the respective prescribed periods, you notify the Company that you have so arranged for the purchase of such Shares, or the Company notifies you that it has so arranged for the purchase of such Shares, you or the Company shall have the right to postpone such Time of Delivery for a period of not more than seven days, in order to effect whatever changes may thereby be made necessary in the Registration Statement or the Prospectus, or in any other documents or arrangements, and the Company agrees to file promptly any amendments or supplements to the Registration Statement or the Prospectus which in your opinion may thereby
23
be made necessary. The term Underwriter as used in this Agreement shall include any person substituted under this Section with like effect as if such person had originally been a party to this Agreement with respect to such Shares.
(b) If, after giving effect to any arrangements for the purchase of the Shares of a defaulting Underwriter or Underwriters by you and the Company as provided in subsection (a) above, the aggregate number of such Shares which remains unpurchased does not exceed one-eleventh of the aggregate number of all the Shares to be purchased at such Time of Delivery, then the Company shall have the right to require each non-defaulting Underwriter to purchase the number of shares which such Underwriter agreed to purchase hereunder at such Time of Delivery and, in addition, to require each non-defaulting Underwriter to purchase its pro rata share (based on the number of Shares which such Underwriter agreed to purchase hereunder) of the Shares of such defaulting Underwriter or Underwriters for which such arrangements have not been made; but nothing herein shall relieve a defaulting Underwriter from liability for its default.
(c) If, after giving effect to any arrangements for the purchase of the Shares of a defaulting Underwriter or Underwriters by you and the Company as provided in subsection (a) above, the aggregate number of such Shares which remains unpurchased exceeds one-eleventh of the aggregate number of all the Shares to be purchased at such Time of Delivery, or if the Company shall not exercise the right described in subsection (b) above to require non-defaulting Underwriters to purchase Shares of a defaulting Underwriter or Underwriters, then this Agreement (or, with respect to the Second Time of Delivery, the obligations of the Underwriters to purchase and of the Company to sell the Optional Shares) shall thereupon terminate, without liability on the part of any non-defaulting Underwriter or the Company, except for the expenses to be borne by the Company and the Underwriters as provided in Section 7 hereof and the indemnity and contribution agreements in Section 9 hereof; but nothing herein shall relieve a defaulting Underwriter from liability for its default.
11. The respective indemnities, agreements, representations, warranties and other statements of the Company and the several Underwriters, as set forth in this Agreement or made by or on behalf of them, respectively, pursuant to this Agreement, shall remain in full force and effect, regardless of any investigation (or any statement as to the results thereof) made by or on behalf of any Underwriter or any controlling person of any Underwriter, or the Company, or any officer or director or controlling person of the Company, and shall survive delivery of and payment for the Shares.
12. If this Agreement shall be terminated pursuant to Section 10 hereof, the Company shall not then be under any liability to any Underwriter except as provided in Sections 7 and 9 hereof; but, if for any other reason, any Shares are not delivered by or on behalf of the Company as provided herein, the Company will reimburse the Underwriters through you for all out-of-pocket expenses approved in writing by you, including fees and disbursements of counsel, reasonably incurred by the Underwriters in making preparations for the purchase, sale and delivery of the Shares not so delivered, but the Company shall then be under no further liability to any Underwriter except as provided in Sections 7 and 9 hereof.
13. In all dealings hereunder, you shall act on behalf of each of the Underwriters, and the parties hereto shall be entitled to act and rely upon any statement, request, notice or agreement
24
on behalf of any Underwriter made or given by Goldman Sachs & Co. LLC and Jefferies LLC on behalf of you as the representatives.
All statements, requests, notices and agreements hereunder shall be in writing, and if to the Underwriters shall be delivered or sent by mail, telex or facsimile transmission to you as the representatives in care of Goldman Sachs & Co. LLC, 200 West Street, New York, New York 10282-2198, Attention: Registration Department, and in care of Jefferies LLC, 520 Madison Avenue, New York, New York 10022, Facsimile: (646) 619-4437, Attention: General Counsel; and if to the Company shall be delivered or sent by mail, telex or facsimile transmission to the address of the Company set forth in the Registration Statement, Attention: Secretary; provided, however, that any notice to an Underwriter pursuant to Section 9(c) hereof shall be delivered or sent by mail, telex or facsimile transmission to such Underwriter at its address set forth in its Underwriters Questionnaire, or telex constituting such Questionnaire, which address will be supplied to the Company by you upon request; and provided further, however, that notices under Section 5(e) shall be in writing, and if to the Underwriters shall be delivered or sent by mail, telex or facsimile transmission to you as the representatives at Goldman Sachs & Co. LLC, 200 West Street, New York, New York 10282-2198, Attention: Control Room; and at Jefferies LLC, 520 Madison Avenue, New York, New York 10022, Facsimile: (646) 619-4437, Attention: General Counsel. Any such statements, requests, notices or agreements shall take effect upon receipt thereof.
In accordance with the requirements of the USA Patriot Act (Title III of Pub. L. 107-56 (signed into law October 26, 2001)), the Underwriters are required to obtain, verify and record information that identifies their respective clients, including the Company, which information may include the name and address of their respective clients, as well as other information that will allow the Underwriters to properly identify their respective clients.
14. This Agreement shall be binding upon, and inure solely to the benefit of, the Underwriters, the Company and, to the extent provided in Sections 9 and 11 hereof, the officers and directors of the Company and each person who controls the Company or any Underwriter, and their respective heirs, executors, administrators, successors and assigns, and no other person shall acquire or have any right under or by virtue of this Agreement. No purchaser of any of the Shares from any Underwriter shall be deemed a successor or assign by reason merely of such purchase.
15. Time shall be of the essence of this Agreement. As used herein, the term business day shall mean any day when the Commissions office in Washington, D.C. is open for business.
16. The Company acknowledges and agrees that (i) the purchase and sale of the Shares pursuant to this Agreement is an arms-length commercial transaction between the Company, on the one hand, and the several Underwriters, on the other, (ii) in connection therewith and with the process leading to such transaction each Underwriter is acting solely as a principal and not the agent or fiduciary of the Company, (iii) no Underwriter has assumed an advisory or fiduciary responsibility in favor of the Company with respect to the offering contemplated hereby or the process leading thereto (irrespective of whether such Underwriter has advised or is currently advising the Company on other matters) or any other obligation to the Company except the obligations expressly set forth in this Agreement and (iv) the Company has consulted its own
25
legal and financial advisors to the extent it deemed appropriate. The Company agrees that it will not claim that the Underwriters, or any of them, has rendered advisory services of any nature or respect, or owes a fiduciary or similar duty to the Company, in connection with such transaction or the process leading thereto.
17. This Agreement supersedes all prior agreements and understandings (whether written or oral) between the Company and the Underwriters, or any of them, with respect to the subject matter hereof.
18. This Agreement and any transaction contemplated by this Agreement shall be governed by and construed in accordance with the laws of the State of New York without regard to principles of conflict of laws that would results in the application of any other law than the laws of the State of New York. The Company agrees that any suit or proceeding arising in respect of this Agreement or any transaction contemplated by this Agreement will be tried exclusively in the U.S. District Court for the Southern District of New York or, if that court does not have subject matter jurisdiction, in any state court located in The City and County of New York and the Company agrees to submit to the jurisdiction of, and to venue in, such courts.
19. The Company and each of the Underwriters hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to this Agreement or the transactions contemplated hereby.
20. This Agreement may be executed by any one or more of the parties hereto in any number of counterparts, each of which shall be deemed to be an original, but all such counterparts shall together constitute one and the same instrument.
21. Notwithstanding anything herein to the contrary, the Company is authorized to disclose to any persons the U.S. federal and state income tax treatment and tax structure of the potential transaction and all materials of any kind (including tax opinions and other tax analyses) provided to the Company relating to that treatment and structure, without the Underwriters imposing any limitation of any kind. However, any information relating to the tax treatment and tax structure shall remain confidential (and the foregoing sentence shall not apply) to the extent necessary to enable any person to comply with securities laws. For this purpose, tax structure is limited to any facts that may be relevant to that treatment.
(Signature page follows)
26
If the foregoing is in accordance with your understanding, please sign and return to us one for the Company and each of the Representatives plus one for each counsel counterparts hereof, and upon the acceptance hereof by you, on behalf of each of the Underwriters, this letter and such acceptance hereof shall constitute a binding agreement between each of the Underwriters and the Company. It is understood that your acceptance of this letter on behalf of each of the Underwriters is pursuant to the authority set forth in a form of Agreement among Underwriters, the form of which shall be submitted to the Company for examination upon request, but without warranty on your part as to the authority of the signers thereof.
Very truly yours, |
||
Odonate Therapeutics, Inc. |
||
By: |
||
Name: |
||
Title: |
Accepted as of the date hereof:
Goldman Sachs & Co. LLC | ||
By: | ||
Name: |
||
Title: |
Jefferies LLC | ||
By: |
||
Name: |
||
Title: |
On behalf of each of the Underwriters
27
SCHEDULE I
Total Number of Firm Shares to be |
Number of Optional Shares to be Purchased if Maximum Option |
|||||||
Underwriter |
Purchased |
Exercised |
||||||
Goldman Sachs & Co. LLC |
||||||||
Jefferies LLC |
||||||||
Cowen and Company, LLC |
||||||||
|
|
|
|
|||||
Total |
||||||||
|
|
|
|
SCHEDULE II
(a) Issuer Free Writing Prospectuses not included in the Pricing Disclosure Package:
[]
(b) Additional Documents Incorporated by Reference:
[None]
(c) Information other than the Pricing Prospectus that comprise the Pricing Disclosure Package:
The initial public offering price per share for the Shares is $[]
The number of Firm Shares purchased by the Underwriters is [].
The number of Optional Shares is [].
[(d) Section 5(d) Writings:
[]]
ANNEX 1
Odonate Therapeutics, LLC
Lock-Up Agreement
, 2017
Goldman Sachs & Co. LLC
Jefferies LLC
c/o Goldman Sachs & Co. LLC
200 West Street
New York, NY 10282-2198
c/o Jefferies LLC
520 Madison Avenue
New York, New York 10022
Re: Odonate Therapeutics, LLC - Lock-Up Agreement
Ladies and Gentlemen:
The undersigned understands that you, as representatives (the Representatives), propose to enter into an Underwriting Agreement on behalf of the several Underwriters named in Schedule I to such agreement (collectively, the Underwriters), with Odonate Therapeutics, LLC, a Delaware limited liability company (including the successor entity upon its corporate conversion, the Company), providing for a public offering (the Public Offering) of shares (the Shares) of the Common Stock of the Company (the Common Stock) pursuant to a Registration Statement on Form S-1 to be filed with the Securities and Exchange Commission (the SEC).
In consideration of the agreement by the Underwriters to offer and sell the Shares, and of other good and valuable consideration the receipt and sufficiency of which is hereby acknowledged, the undersigned agrees that, during the period beginning from the date of this Lock-Up Agreement and continuing to and including the date 180 days after the date set forth on the final prospectus used to sell the Shares (the Lock-Up Period), the undersigned will not offer, sell, contract to sell, pledge, grant any option to purchase, make any short sale or otherwise dispose of any membership interests in the Company (including, without limitation, common units or incentive units) (Membership Interests), any shares of Common Stock, or any options or warrants to purchase any Membership Interests or shares of Common Stock, or any securities convertible into, exchangeable for or that represent the right to receive Membership Interests or shares of Common Stock (collectively, the Equity Securities), whether now owned or hereinafter acquired, owned directly by the undersigned (including holding as a custodian) or with respect to which the undersigned has beneficial ownership within the rules and regulations of the SEC (collectively, the Undersigneds Securities), exercise any right with respect to the
I-1
registration of the Undersigneds Securities, or file or cause to be filed any registration statement in connection therewith, under the Securities Act of 1933, as amended, or publicly announce the intention to engage in any of the foregoing transactions. The foregoing restriction is expressly agreed to preclude the undersigned from engaging in any hedging or other transaction which is designed to or which reasonably could be expected to lead to or result in a sale or disposition of the Undersigneds Securities even if the Undersigneds Securities would be disposed of by someone other than the undersigned. Such prohibited hedging or other transactions would include without limitation any short sale or any purchase, sale or grant of any right (including without limitation any put or call option) with respect to any of the Undersigneds Securities or with respect to any security that includes, relates to, or derives any significant part of its value from the Undersigneds Securities.
If the undersigned is an officer or director of the Company, (i) Goldman Sachs & Co. LLC and Jefferies LLC agree that, at least three business days before the effective date of any release or waiver of the foregoing restrictions in connection with a transfer of Equity Securities, Goldman Sachs & Co. LLC and Jefferies LLC will notify the Company of the impending release or waiver, and (ii) the Company has agreed or will agree in the Underwriting Agreement to announce the impending release or waiver by press release through a major news service at least two business days before the effective date of the release or waiver. Any release or waiver granted by Goldman Sachs & Co. LLC and Jefferies LLC hereunder to any such officer or director shall only be effective two business days after the publication date of such press release. The provisions of this paragraph will not apply if (a) the release or waiver is effected solely to permit a transfer not for consideration and (b) the transferee has agreed in writing to be bound by the same terms described in this letter to the extent and for the duration that such terms remain in effect at the time of the transfer.
Notwithstanding the foregoing, the undersigned may:
(a) |
transfer the Undersigneds Securities: |
(i) |
as a bona fide gift or gifts, provided that the donee or donees thereof agree to be bound in writing by the restrictions set forth herein; |
(ii) |
to any trust for the direct or indirect benefit of the undersigned or the immediate family of the undersigned, provided that the trustee of the trust agrees to be bound in writing by the restrictions set forth herein, and provided further that any such transfer shall not involve a disposition for value; |
(iii) |
if the undersigned is a corporation, partnership, limited liability company, trust or other business entity (A) to another corporation, partnership, limited liability company, trust or other business entity that is an affiliate (as defined in Rule 405 promulgated under the Securities Act of 1933, as amended) of the undersigned, or to any investment fund or other entity controlled or managed by the undersigned or affiliates of the undersigned, or (B) as part of a distribution, transfer or disposition |
I-2
without consideration by the undersigned to its stockholders, partners, members, beneficiaries or other equity holders; provided , however , that in the case of any transfer contemplated in (A) or (B) above, it shall be a condition to the transfer that the transferee execute an agreement stating that the transferee is receiving and holding such capital stock subject to the provisions of this Lock-up Agreement and there shall be no further transfer of such capital stock except in accordance with this Lock-up Agreement; and provided further that any such transfer shall not involve a disposition for value; |
(iv) |
by will or intestate succession upon the death of the undersigned, provided that the legatee, heir or other transferee agrees to be bound in writing by the restrictions set forth herein; |
(v) |
pursuant to the conversion of outstanding Membership Interests into shares of Common Stock upon the conversion of the Company from a limited liability company into a corporation in connection with the Public Offering, provided that the shares of Common Stock received upon such conversion shall be subject to the restrictions set forth herein; |
(vi) |
with the prior written consent of Goldman Sachs & Co. LLC and Jefferies LLC on behalf of the Underwriters; or |
(b) |
enter into a written plan meeting the requirements of Rule 10b5-1 under the Securities Exchange Act of 1934, as amended (the Exchange Act), relating to the transfer, sale or other disposition of securities of the Company (a Trading Plan), provided that no public announcement or filing under the Exchange Act regarding the establishment of such Trading Plan shall be required of or made by or on behalf of the undersigned or the Company during the Lock-Up Period and, provided further, that no transfers, sales or other dispositions are made during the Lock-Up Period pursuant to this new Trading Plan; or |
(c) |
transfer the Undersigneds Securities that are shares of Common Stock purchased in the Public Offering or at any time thereafter. |
In addition, with respect to clauses (a)(i) through (a)(vi) and clause (c) above, it shall be a condition to such transfer that no filing under the Exchange Act (including, without limitation, Section 16(a) thereof) nor any other public filing or disclosure of such transfer by or on behalf of the undersigned, reporting a reduction in beneficial ownership of the Equity Securities, shall be required or made until after the expiration of the Lock-Up Period.
In the event that another holder of Shares who is a party to a lock-up agreement with the Underwriters with respect to the Public Offering (collectively, the Restricted Parties) is released from its obligations under such lock-up agreement, then the Underwriters shall: (i) provide prompt written notice of such release (to be delivered within two business days from the date of such release), and (ii) release, on a pro rata basis with all other Restricted Parties, the undersigned from its obligations under this Lock-Up
I-3
Agreement. The Underwriters represent and warrant that all Restricted Parties are subject to lock-up agreements with terms substantially similar to those set forth herein.
For purposes of this Lock-Up Agreement, immediate family shall mean any relationship by blood, marriage or adoption, not more remote than first cousin.
The undersigned now has, and, except as contemplated by clauses (a) through (c) above, for the duration of this Lock-Up Agreement will have, good and marketable title to the Undersigneds Securities, free and clear of all liens, encumbrances, and claims whatsoever. The undersigned also agrees and consents to the entry of stop transfer instructions with the Companys transfer agent and registrar against the transfer of the Undersigneds Securities except in compliance with the foregoing restrictions.
The undersigned understands that the Company and the Underwriters are relying upon this Lock-Up Agreement in proceeding toward consummation of the offering. The undersigned further understands that this Lock-Up Agreement is irrevocable and shall be binding upon the undersigneds heirs, legal representatives, successors, and assigns.
This Lock-Up Agreement and related restrictions shall automatically terminate upon the earliest to occur, if any, of (a) the registration statement related to the Public Offering is withdrawn, (b) the Representatives or the Company advising the other in writing that it has determined not to proceed with the Public Offering, (c) February 14, 2018 if the Underwriting Agreement is not executed before such date, or (d) the termination of the Underwriting Agreement before the sale of any Shares to the Underwriters.
(Signature page follows)
I-4
Very truly yours,
Signature Page to Lock-Up Agreement
(Odonate Therapeutics, Inc. Initial Public Offering)
ANNEX II
Form of Press Release
Odonate Therapeutics, Inc.
[Date]
Odonate Therapeutics, Inc. (the Company) announced today that Goldman Sachs & Co. LLC and Jefferies LLC, the joint book-running managers in the Companys recent public sale of shares of common stock, are [waiving] [releasing] a lock-up restriction with respect to shares of the Companys common stock held by [certain officers or directors] [an officer or director] of the Company. The [waiver] [release] will take effect on , 20 , and the shares may be sold on or after such date.
This press release is not an offer for sale of the securities in the United States or in any other jurisdiction where such offer is prohibited, and such securities may not be offered or sold in the United States absent registration or an exemption from registration under the United States Securities Act of 1933, as amended.
Exhibit 3.1
CERTIFICATE OF INCORPORATION
OF
ODONATE THERAPEUTICS, INC.
(a Delaware corporation)
ARTICLE I
NAME
The name of the corporation is Odonate Therapeutics, Inc. ( Odonate ).
ARTICLE II
AGENT
The address of Odonates registered office in the State of Delaware is 1209 Orange Street, Wilmington, New Castle County, Delaware 19801. The name of its registered agent at such address is The Corporation Trust Company.
ARTICLE III
PURPOSE
The purpose of Odonate is to engage in any lawful act or activity for which corporations may be organized under the General Corporation Law of the State of Delaware (the DGCL ).
ARTICLE IV
STOCK
Section 4.1 Authorized Stock . The total number of shares that Odonate shall have authority to issue is 100,000,000, all of which shall be designated as Common Stock, par value $0.01 per share ( Common Stock ).
Section 4.2 Common Stock .
(a) Voting Rights . Each holder of Common Stock, as such, shall be entitled to one vote for each share of Common Stock held of record by such holder on all matters on which stockholders generally are entitled to vote.
(b) Dividends . The holders of shares of Common Stock shall be entitled to receive ratably any dividends to the extent permitted by law when, as and if declared by the board of directors of Odonate (the Board ).
(c) Liquidation . Upon the dissolution, liquidation or winding up of Odonate, the holders of shares of Common Stock shall be entitled to receive the assets of Odonate available for distribution to its stockholders ratably in proportion to the number of shares held by them.
ARTICLE V
BOARD OF DIRECTORS
Section 5.1 Number . The initial Board shall consist of the number of directors either elected by the incorporator or named as initial directors in this certificate of incorporation (the Certificate of Incorporation ). Thereafter, the Board shall consist of such number of directors as shall be determined from time to time pursuant to or in the manner set forth in the Bylaws of Odonate, as amended from time to time (the Bylaws ).
Section 5.2 Vacancies and Newly Created Directorships; Removal; Powers .
(a) Vacancies and Newly Created Directorships . Unless otherwise required by law, newly created directorships resulting from any increase in the authorized number of directors and any vacancies in the Board resulting from death, resignation, retirement, disqualification, removal from office or other cause may be filled by either: (i) the affirmative vote of a majority of the remaining directors then in office and entitled to vote thereon (even though less than a quorum of the Board); or (ii) the sole remaining director. Any director so chosen shall hold office until the next election of directors and until his or her successor shall have been duly elected and qualified. No decrease in the authorized number of directors shall shorten the term of any incumbent director.
(b) Removal . Any director, or the entire Board, may be removed, with or without cause, by the affirmative vote of a majority of the voting power of the Common Stock outstanding and entitled to vote thereon.
(c) Powers . Except as otherwise required by the DGCL or as provided in this Certificate of Incorporation, the business and affairs of Odonate shall be managed by or under the direction of the Board.
Section 5.3 Election; Notice of Nominations and Business .
(a) Election . No person entitled to vote at an election of directors may cumulate votes to which such person is entitled, unless required by applicable law at the time of such election. The directors of Odonate need not be elected by written ballot unless the Bylaws so provide.
(b) Notice . Advance notice of nominations for the election of directors, and of business other than nominations, to be proposed by stockholders for consideration at a meeting of stockholders of Odonate shall be given in the manner and to the extent provided in the Bylaws.
ARTICLE VI
SPECIAL MEETINGS OF STOCKHOLDERS
A special meeting of the stockholders of Odonate: (a) may be called at any time by the Board; and (b) shall be called by the Secretary of Odonate upon the written request of one or more stockholders who: (i) beneficially own at least 10% of the Common Stock; and (ii) comply with such procedures for requesting a special meeting of stockholders as may be set forth in the
2
Bylaws. Except as otherwise required by law, special meetings of the stockholders of Odonate may not be called by any other person or persons.
ARTICLE VII
BUSINESS COMBINATIONS WITH INTERESTED STOCKHOLDERS
Odonate hereby expressly elects that it shall not be bound or governed by, or otherwise subject to, Section 203 of the DGCL.
ARTICLE VIII
EXISTENCE
Odonate shall have perpetual existence.
ARTICLE IX
AMENDMENT
Section 9.1 Amendment of Certificate of Incorporation . Odonate reserves the right, at any time and from time to time, to amend, alter, change or repeal any provision contained in this Certificate of Incorporation, and to add or insert other provisions authorized by the laws of the State of Delaware at the time in force, in the manner now or hereafter prescribed by the laws of the State of Delaware. All powers, preferences and rights of any nature conferred upon stockholders, directors or any other persons by and pursuant to this Certificate of Incorporation in its present form or as hereafter amended are granted subject to this reservation.
Section 9.2 Amendment of Bylaws . In furtherance and not in limitation of the powers conferred by the laws of the State of Delaware, the Board is expressly authorized to adopt, amend or repeal the Bylaws. Except as otherwise required in this Certificate of Incorporation or the Bylaws, and in addition to any requirements of law, the affirmative vote of at least a majority of the voting power of the Common Stock outstanding and entitled to vote thereon shall be required for the stockholders to adopt, amend or repeal any provision of the Bylaws.
ARTICLE X
SETTLEMENTS WITH CREDITORS
Whenever a compromise or arrangement is proposed between Odonate and its creditors or any class of them and/or between Odonate and its stockholders or any class of them, any court of equitable jurisdiction within the State of Delaware may, on the application in a summary way of Odonate or of any creditor or stockholder thereof, or on the application of any receiver or receivers appointed for Odonate under § 291 of Title 8 of the Delaware Code or on the application of trustees in dissolution or of any receiver or receivers appointed for Odonate under § 279 of Title 8 of the Delaware Code, order a meeting of the creditors or class of creditors, and/or of the stockholders or class of stockholders of Odonate, as the case may be, to be summoned in such manner as the said court directs. If a majority in number representing three-fourths in value of the creditors or class of creditors, and/or of the stockholders or class of stockholders of Odonate, as the case may be, agree to any compromise or arrangement and to any reorganization of Odonate as a consequence of such compromise or arrangement, the said compromise or arrangement and the said reorganization shall, if sanctioned by the court to which
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the said application has been made, be binding on all of the creditors or class of creditors and/or on all of the stockholders of Odonate, as the case may be, and also on Odonate.
ARTICLE XI
ADJUDICATION OF DISPUTES; CORPORATE OPPORTUNITIES
Section 11.1 Forum . Unless Odonate, in writing, selects or consents to the selection of an alternative forum, the sole and exclusive forum for any current or former stockholder (including any current or former beneficial owner) to bring Internal Corporate Claims (as defined below), to the fullest extent permitted by law, and subject to applicable jurisdictional requirements, shall be the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, another state court or a federal court located within the State of Delaware). For purposes of this Article, Internal Corporate Claims means claims, including claims in the right of Odonate: (a) that are based on an actual or alleged violation of a duty by a current or former director, officer, employee or stockholder in such capacity; or (b) as to which the DGCL confers jurisdiction upon the Court of Chancery.
Section 11.2 Consent to Jurisdiction . If any action, the subject matter of which is within the scope of this Article, is filed in a court other than the Court of Chancery (or, if the Court of Chancery does not have jurisdiction, another state court or a federal court located within the State of Delaware) (a Foreign Action ) by any current or former stockholder (including any current or former beneficial owner), such stockholder shall be deemed to have consented to: (a) the personal jurisdiction of the Court of Chancery (or such other state or federal court located within the State of Delaware, as applicable) in connection with any action brought in any such court to enforce this Article; and (b) having service of process made upon such stockholder in any such action by service upon such stockholders counsel in the Foreign Action as agent for such stockholder.
Section 11.3 Enforceability . If any provision of this Article shall be held to be invalid, illegal or unenforceable as applied to any person or entity or circumstance for any reason whatsoever, then, to the fullest extent permitted by law, the validity, legality and enforceability of such provision in any other circumstance and of the remaining provisions of this Article (including, without limitation, each portion of any sentence of this Article containing any such provision held to be invalid, illegal or unenforceable that is not itself held to be invalid, illegal or unenforceable), and the application of such provision to other persons or entities or circumstances shall not in any way be affected or impaired thereby.
Section 11.4 Corporate Opportunities . To the fullest extent permitted by applicable law, Odonate renounces any interest or expectancy of Odonate in, or in being offered an opportunity to participate in, any Excluded Opportunity. An Excluded Opportunity is any matter, transaction or interest that is either: (a) presented to, or acquired, created or developed by, or which otherwise comes into the possession of, any director of Odonate who is not an employee of Odonate or any of its subsidiaries, (collectively, Covered Persons ), unless such matter, transaction or interest is presented to, or acquired, created or developed by, or otherwise comes into the possession of, a Covered Person expressly and solely in such Covered Persons capacity as a director of Odonate; or (b) not in the field of oncology
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ARTICLE XII
INCORPORATOR
The name and mailing address of the incorporator are as follows:
Kevin C. Tang
c/o Odonate Therapeutics, LLC
4747 Executive Drive, Suite 510
San Diego, California 92121
ARTICLE XIII
ELECTION OF INITIAL DIRECTORS
The powers of the incorporator are to terminate upon the filing of this Certificate of Incorporation with the Secretary of State of the State of Delaware. The names of the persons who are to serve as the initial directors of Odonate until the first annual meeting of stockholders of Odonate, or until their successors shall have been duly elected and qualified, are set forth below:
Kevin C. Tang
Jeff L. Vacirca, M.D.
Aaron I. Davis
Craig A. Johnson
Robert H. Rosen
George F. Tidmarsh, M.D., Ph.D.
The address of each such initial director shall be c/o Odonate Therapeutics, Inc., 4747 Executive Drive, Suite 510, San Diego, California 92121.
[ The remainder of this page has been intentionally left blank. ]
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IN WITNESS WHEREOF, the undersigned incorporator hereby acknowledges that the foregoing Certificate of Incorporation is his act and deed and that the facts stated herein are true.
Dated: | ||||||
By: | ||||||
Name: Kevin C. Tang | ||||||
Title: Incorporator |
S IGNATURE P AGE TO C ERTIFICATE OF I NCORPORATION
Exhibit 3.2
BYLAWS
OF
ODONATE THERAPEUTICS, INC.
(a Delaware corporation)
ARTICLE I
MEETINGS OF STOCKHOLDERS
Section 1.1 Annual Meeting . The annual meeting of stockholders, for the election of directors and for the transaction of such other business as may properly come before the meeting, shall be held at such place, if any, either within or outside of the State of Delaware, on such date, and at such time as the Board of Directors (the Board ) of Odonate Therapeutics, Inc. ( Odonate ) shall fix.
Section 1.2 Special Meeting .
(a) A special meeting of the stockholders may be called at any time by the Board and shall be called by the Secretary on the written request of one or more stockholders who beneficially own at least 10% of the issued and outstanding common stock, par value $0.01 per share (the Common Stock ), of Odonate. The business conducted at a special meeting will be limited to business brought by or at the direction of the Board and business set forth in the stockholder request that resulted in a special meeting being called in accordance with this Section. For every special meeting of stockholders, the notice of meeting shall set forth the purpose of the meeting.
(b) A written request to call a special meeting will not be valid unless it is signed by or on behalf of one or more stockholders who beneficially own, in the aggregate, 10% or more of the issued and outstanding Common Stock as of the date the request is delivered to the Secretary. The request shall set forth: (i) the business to be transacted at the special meeting (including any nominees for director proposed by the requesting stockholders to be elected); (ii) the name and address of each stockholder submitting the request and of each beneficial owner (if any) on whose behalf the request is being submitted; (iii) all of the information about the business or nominees for director that a stockholder would be required to provide under Section 1.9 if the business or nominations were acted on at an annual meeting of stockholders; and (iv) documentary evidence of beneficial ownership of the Common Stock owned by the stockholders. Odonate may request that the stockholder(s) provide additional documentation to demonstrate beneficial ownership of 10% or more of the Common Stock as of the date of delivery of the request. Following Odonates receipt of the request, the Board shall promptly (and in any event within 30 days) fix the date, time and place of the special meeting. The special meeting must be convened within 90 days of the receipt of the request. The Board may present business to be transacted at any special meeting called at the request of stockholders.
Section 1.3 Notice of Stockholders Meetings . Whenever stockholders are required or permitted to take any action at a meeting, notice of such meeting shall be given in accordance with Section 222 of the Delaware General Corporation Law (the DGCL ). Except as otherwise required by law, notice may be given personally or by mail, or by electronic transmission to the extent permitted by Section 232 of the DGCL. To the extent required by law, notice of an adjourned meeting shall be given in accordance with Section 222(c) of the DGCL.
Section 1.4 Organization . The Chairman of the Board, or in his or her absence the Chief Executive Officer, or in his or her absence any other person designated by the Board, the Chairman of the Board or the Chief Executive Officer, shall act as chairman of and preside at any meeting of the stockholders. Each of the chairman of the meeting and the Board shall have the authority to adopt and enforce rules providing for the orderly conduct of the meeting and the safety of those in attendance.
Section 1.5 List of Stockholders . A list of stockholders of Odonate shall be prepared and made available for inspection by stockholders in advance of a meeting of stockholders to the extent required by, and in accordance with, Section 219 of the DGCL.
Section 1.6 Quorum . Except as otherwise required by law, the Certificate of Incorporation or these Bylaws, at any meeting of stockholders, a majority of the voting power of the Common Stock outstanding and entitled to vote at the meeting, present in person or represented by proxy, shall constitute a quorum for the transaction of business.
Section 1.7 Adjourned Meeting . Any annual or special meeting of stockholders, whether or not a quorum is present, may be adjourned for any reason by the chairman of the meeting or by a majority of the voting power of the stock present in person or represented by proxy at the meeting and entitled to vote thereon. At any such adjourned meeting at which a quorum may be present, any business may be transacted that might have been transacted at the meeting as originally called.
Section 1.8 Voting; Proxies .
(a) Except as otherwise required by law, the Certificate of Incorporation, these Bylaws or any law, rule or regulation applicable to Odonate or its securities, at each meeting of stockholders at which a quorum is present, all corporate actions to be taken by vote of the stockholders shall be authorized by the affirmative vote of a majority of the voting power of the stock present in person or represented by proxy and entitled to vote on the subject matter. Voting at meetings of stockholders need not be by written ballot.
(b) A stockholder may authorize another person or persons to act for such stockholder as proxy in accordance with Section 212 of the DGCL.
Section 1.9 Notice of Stockholder Business and Nominations .
(a) Annual Meeting Notice .
(i) Nominations for director election and the proposal of other business may be made at an annual meeting of stockholders only: (A) pursuant to Odonates
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notice of meeting; (B) by or at the direction of the Board; or (C) by any person who is a stockholder of record at the time the notice provided for in this Section 1.9(a) is delivered to the Secretary of Odonate, who is entitled to vote at the meeting and who complies with the notice procedures set forth in this Section. The foregoing clause (C) shall be the exclusive means for a stockholder to make nominations or propose other business at an annual meeting of stockholders (other than a proposal included in Odonates proxy statement in compliance with Rule 14a-8 under the Securities Exchange Act of 1934 (the Exchange Act )).
(ii) A stockholders notice must be received by the Secretary not later than the 90th day before the anniversary of the last annual meeting; provided , however , that if the date of the annual meeting is more than 30 days before or more than 30 days after such anniversary date, or if no annual meeting was held in the preceding year, notice by the stockholder must be delivered not later than the 20th day after the first public announcement of the date of such meeting by Odonate. Such stockholders notice shall set forth:
(A) as to each nominee for director election: (1) all information about the nominee that is required to be disclosed in solicitations of proxies for election of directors in an election contest, or is otherwise required, in each case pursuant to and in accordance with Regulation 14A under the Exchange Act; (2) the nominees written consent to serve as a director, if elected; and (3) a completed questionnaire, signed by the nominee, in the form that Odonate requires its nominees to complete and sign;
(B) as to any other business that the stockholder proposes to bring before the meeting, the text of the proposal or business, the reasons for conducting such business at the meeting and any material interest in such business of such stockholder and the beneficial owner, if any, on whose behalf the proposal is made; and
(C) as to the stockholder giving the notice and the beneficial owner, if any, on whose behalf the nomination is made or the other business is proposed: (1) the name and address for each stockholder and beneficial owner; (2) the number of shares that are owned beneficially and of record (directly or indirectly) by each such stockholder and beneficial owner; (3) all other related ownership interests, including, but not limited to, derivatives, hedged positions, synthetic and temporary ownership techniques, swaps, securities loans, timed purchases and other economic interests directly or indirectly owned beneficially by each stockholder and beneficial owner; (4) any proxy, contract, arrangement, understanding, or relationship pursuant to which either party has a right to vote, directly or indirectly, any shares of any security of Odonate; and (5) a representation whether the stockholder or the beneficial owner, if any, will engage in a solicitation with respect to the nomination or other business and whether such person intends or is part of a group which intends to deliver a proxy statement and/or form of proxy to holders of shares representing at least 50% of the Common Stock.
(iii) In the event that the number of directors to be elected to the Board at an annual meeting is increased and there is no public announcement by Odonate naming all of the nominees for director or specifying the size of the increased Board made by Odonate at least 10 days prior to the last day a stockholder may deliver a notice in accordance with Section 1.9(a)(ii) above, a stockholders notice required by this Section 1.9(a) shall also be considered timely, but only with respect to nominees for any new positions created by such
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increase, if it shall be received by the Secretary not later than the 10th day after such public announcement is first made by Odonate.
(b) Special Meeting Notice . Nominations of persons for election to the Board may be made at a special meeting of stockholders at which directors are to be elected pursuant to Odonates notice of meeting: (i) by or at the direction of the Board; (ii) provided that one or more directors are to be elected at such meeting, by any stockholder of Odonate who is a stockholder of record at the time the notice provided for in this Section 1.9(b) is delivered to the Secretary, who is entitled to vote at the meeting and who delivers a written notice of nomination setting forth the information required by Section 1.9(a) above; or (iii) in the case of a stockholder-requested special meeting, by any stockholder of Odonate pursuant to Section 1.2. In the event Odonate calls a special meeting of stockholders (other than a stockholder-requested special meeting) for the purpose of electing one or more directors to the Board, any stockholder entitled to vote in such election of directors may nominate person(s) for election to such position(s) as specified in Odonates notice of meeting, if the notice required by this Section 1.9(b) is received by the Secretary not later than the 20th day following the date on which public announcement of the date of the special meeting and of the nominees proposed by the Board to be elected at such meeting is first made by Odonate. Notwithstanding any other provision of these Bylaws, in the case of a stockholder-requested special meeting, no stockholder may nominate a person for election to the Board or propose any other business to be considered at the meeting, except pursuant to the written request delivered for such special meeting pursuant to Section 1.2.
(c) General .
(i) Except as otherwise required by law, only such persons who are nominated in accordance with the procedures set forth in this Section 1.9 shall be eligible to be elected at any meeting of stockholders of Odonate to serve as directors and only such other business shall be conducted at a meeting of stockholders as shall have been brought before the meeting in accordance with the procedures set forth in this Section 1.9. No adjournment or postponement of a meeting of stockholders will commence a new time period for the giving of a stockholders notice as described above.
(ii) For purposes of this Section 1.9, a public announcement shall mean disclosure in a press release reported by the Dow Jones News Service, Associated Press or a comparable national news service or in a document publicly filed by Odonate with the Securities and Exchange Commission pursuant to Sections 13, 14 or 15(d) of the Exchange Act.
Section 1.10 Action by Written Consent . Any action required or permitted to be taken at any meeting of stockholders may be taken without a meeting, without prior notice and without a vote, in accordance with Section 228 of the DGCL.
Section 1.11 Inspectors of Election . Before any meeting of stockholders, Odonate shall appoint one or more inspectors of election to perform the duties required by Section 231 of the DGCL.
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ARTICLE II
DIRECTORS
Section 2.1 Powers . Except as otherwise required by the DGCL or as provided in the Certificate of Incorporation, the business and affairs of Odonate shall be managed by or under the direction of the Board.
Section 2.2 Number, Term of Office and Election . Except as otherwise provided for or fixed pursuant to the Certificate of Incorporation, the Board shall consist of such number of directors as shall be determined solely by resolution adopted by the affirmative vote of a majority of the total number of directors then authorized (hereinafter referred to as the Whole Board ). At any meeting of stockholders at which directors are to be elected, directors shall be elected by a plurality of the votes cast. Each director shall hold office until the next election of directors and until his or her successor shall have been duly elected and qualified.
Section 2.3 Vacancies and Newly Created Directorships . Unless otherwise required by law, newly created directorships resulting from any increase in the authorized number of directors and any vacancies in the Board resulting from death, resignation, retirement, disqualification, removal or other cause may be filled by the affirmative vote of a majority of the remaining directors then in office and entitled to vote thereon, even though less than a quorum of the Board, or by the sole remaining director. Any director so chosen shall hold office until the next election of directors and until his or her successor shall have been duly elected and qualified. No decrease in the authorized number of directors shall shorten the term of any incumbent director.
Section 2.4 Resignations . Any director may resign at any time with notice given in writing or by electronic transmission to the Board, the Chairman of the Board or the Secretary of Odonate. Such resignation shall take effect on delivery, unless the resignation specifies a later effective date or time or an effective date or time determined on the happening of an event or events. Unless otherwise specified therein, the acceptance of such resignation shall not be necessary to make it effective.
Section 2.5 Regular Board Meetings . Regular meetings of the Board shall be held at such place or places (if any), within or outside the State of Delaware, on such date or dates and at such time or times, as shall have been established by the Board and publicized among all directors. A notice of each regular meeting shall not be required.
Section 2.6 Special Board Meetings . Special meetings of the Board for any purpose may be called at any time by the Chairman of the Board, the Chief Executive Officer or a majority of the directors then in office. The person or persons authorized to call special meetings of the Board may fix the place (if any), within or outside the State of Delaware, date and time of such meetings. Notice of each such meeting shall be given to each director, if by mail, addressed to such director at his or her residence or usual place of business, at least five days before the day on which such meeting is to be held, or shall be sent to such director by email, or be delivered personally or by telephone, in each case at least 24 hours prior to the time set for such meeting. A notice of special meeting need not state the purpose of such meeting, and, unless indicated in the notice thereof, any and all business may be transacted at a special meeting.
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Section 2.7 Quorum and Voting . Except as otherwise required by law, the Certificate of Incorporation or these Bylaws, a majority of the Whole Board shall constitute a quorum for the transaction of business at any meeting of the Board, and the vote of a majority of the directors present at a duly held meeting at which a quorum is present shall be the act of the Board. The chairman of the meeting or a majority of the directors present may adjourn the meeting to another time and place whether or not a quorum is present. At any adjourned meeting at which a quorum is present, any business may be transacted which might have been transacted at the meeting as originally called.
Section 2.8 Board Action by Written Consent Without a Meeting . Any action required or permitted to be taken at any meeting of the Board, or any committee thereof, may be taken without a meeting in accordance with Section 141(f) of the DGCL.
Section 2.9 Chairman of the Board . The Chairman of the Board shall preside at meetings of directors and shall perform such other duties as the Board may from time to time determine. If the Chairman of the Board is not present at a meeting of the Board, another director chosen by the Board shall preside.
Section 2.10 Fees and Compensation of Directors . Unless otherwise restricted by the Certificate of Incorporation, directors may receive such compensation, if any, for their services on the Board and its committees, and such reimbursement of expenses, as may be fixed or determined by resolution of the Board.
ARTICLE III
COMMITTEES
Section 3.1 Committees of the Board . The Board may designate one or more committees in accordance with Section 141(c)(2) of the DGCL, and each such committee shall consist of one or more of the directors. In the absence or disqualification of a member of a committee, the member or members present at any meeting and not disqualified from voting, whether or not he, she or they constitute a quorum, may unanimously appoint another member of the Board to act at the meeting in the place of any such absent or disqualified member. Any such committee, to the extent permitted by law and provided in a resolution of the Board, shall have and may exercise all the powers and authority of the Board in the management of the business and affairs of Odonate, and may authorize the seal of Odonate to be affixed to all papers which may require it; but no such committee shall have the power or authority in reference to the following matters: (a) approving or adopting, or recommending to the stockholders, any action or matter (other than the election or removal of directors) expressly required by the DGCL to be submitted to stockholders for approval; or (b) adopting, amending or repealing any bylaw of Odonate.
Section 3.2 Meetings and Action of Committees . Unless the Board provides otherwise by resolution, any committee of the Board may adopt, alter and repeal such rules and regulations not inconsistent with the provisions of law, the Certificate of Incorporation or these Bylaws for the conduct of its meetings as such committee may deem proper. Except as otherwise provided in a resolution of the Board: (a) a majority of the directors then serving on a committee shall constitute a quorum for the transaction of business by the committee; and (b) the vote of a
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majority of the members of a committee present at a meeting at which a quorum is present shall be the act of the committee.
ARTICLE IV
OFFICERS
Section 4.1 Officers . The officers of Odonate may consist of a Chief Executive Officer, a Chief Operating Officer, a Chief Financial Officer, a Secretary and such other officers as the Board may from time to time determine, each of whom shall be elected by the Board, each to have such authority, functions or duties as set forth in these Bylaws or as determined by the Board. Each officer shall be elected by the Board and shall hold office for such term as may be prescribed by the Board and until such persons successor shall have been duly elected and qualified, or until such persons earlier death, disqualification, resignation or removal. Any number of offices may be held by the same person; provided , however , that no officer shall execute, acknowledge or verify any instrument in more than one capacity if such instrument is required by law, the Certificate of Incorporation or these Bylaws to be executed, acknowledged or verified by two or more officers. The Board may require any officer, agent or employee to give security for the faithful performance of his or her duties.
Section 4.2 Compensation . The salaries of the officers of Odonate and the manner and time of the payment of such salaries shall be fixed and determined by the Board and may be altered by the Board from time to time as it deems appropriate, subject to the rights, if any, of such officers under any contract of employment.
Section 4.3 Removal, Resignation and Vacancies . Any officer of Odonate may be removed, with or without cause, by the Board or by a duly authorized officer, without prejudice to the rights, if any, of such officer under any contract to which it is a party. Any officer may resign at any time on notice given in writing or by electronic transmission to Odonate, without prejudice to the rights, if any, of Odonate under any contract to which such officer is a party. If any vacancy occurs in any office of Odonate, the Board may elect a successor to fill such vacancy for the remainder of the unexpired term and until a successor shall have been duly elected and qualified.
Section 4.4 Additional Matters . The Chief Executive Officer and the Chief Financial Officer of Odonate shall have the authority to designate employees of Odonate to have the title of Vice President, Assistant Vice President, Treasurer, Assistant Treasurer or Assistant Secretary. Any employee so designated shall have the powers and duties determined by the officer making such designation. The persons on whom such titles are conferred shall not be deemed officers of Odonate unless elected by the Board.
Section 4.5 Delegation . The Board may from time to time delegate the powers or duties of any officer to any other officers or agents, notwithstanding the foregoing provisions of this Article.
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ARTICLE V
INDEMNIFICATION AND ADVANCEMENT OF EXPENSES
Section 5.1 Right to Indemnification .
(a) Each person who was or is a party or is threatened to be made a party to, or was or is otherwise involved in, any action, suit, arbitration, alternative dispute resolution mechanism, investigation, inquiry, judicial, administrative or legislative hearing, or any other threatened, pending or completed proceeding, whether brought by or in the right of Odonate or otherwise, including any and all appeals, whether of a civil, criminal, administrative, legislative, investigative or other nature (hereinafter a proceeding ), by reason of the fact that he or she is or was a director or an officer of Odonate or while a director or officer of Odonate is or was serving at the request of Odonate as a director, officer, employee, agent or trustee of another corporation or of a partnership, joint venture, trust or other enterprise, including service with respect to an employee benefit plan (hereinafter an indemnitee ), or by reason of anything done or not done by him or her in any such capacity, shall be indemnified and held harmless by Odonate to the fullest extent authorized by the DGCL, as the same exists or may hereafter be amended, against all expense, liability and loss (including attorneys fees, judgments, fines, ERISA excise taxes, penalties and amounts paid in settlement by or on behalf of the indemnitee) actually and reasonably incurred by such indemnitee in connection therewith, all on the terms and conditions set forth in these Bylaws; provided , however , that, except as otherwise required by law or provided in Section 5.3 with respect to suits to enforce rights under this Article, Odonate shall indemnify any such indemnitee in connection with a proceeding, or part thereof, voluntarily initiated by such indemnitee (including claims and counterclaims, whether such counterclaims are asserted by: (i) such indemnitee; or (ii) Odonate in a proceeding initiated by such indemnitee) only if such proceeding, or part thereof, was authorized or ratified by the Board or the Board otherwise determines that indemnification or advancement of expenses is appropriate.
(b) To receive indemnification under this Section 5.1, an indemnitee shall submit a written request to the Secretary of Odonate. Such request shall include documentation or information that is necessary to determine the entitlement of the indemnitee to indemnification and that is reasonably available to the indemnitee. On receipt by the Secretary of Odonate of such a written request, the entitlement of the indemnitee to indemnification shall be determined by the following person or persons who shall be empowered to make such determination, as selected by the Board (except with respect to clause (v) of this Section 5.1(b)): (i) the Board by a majority vote of the directors who are not parties to such proceeding, whether or not such majority constitutes a quorum; (ii) a committee of such directors designated by a majority vote of such directors, whether or not such majority constitutes a quorum; (iii) if there are no such directors, or if such directors so direct, by independent legal counsel in a written opinion to the Board, a copy of which shall be delivered to the indemnitee; (iv) the stockholders of Odonate; or (v) in the event that a change of control (as defined below) has occurred, by independent legal counsel in a written opinion to the Board, a copy of which shall be delivered to the indemnitee. The determination of entitlement to indemnification shall be made and, unless a contrary determination is made, such indemnification shall be paid in full by Odonate not later than 60 days after receipt by the Secretary of Odonate of a written request for indemnification. For purposes of this Section 5.1(b), a change of control will be deemed to have occurred if, with
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respect to any particular 24-month period, the individuals who, at the beginning of such 24-month period, constituted the Board (the incumbent board ), cease for any reason to constitute at least a majority of the Board; provided , however , that any individual becoming a director subsequent to the beginning of such 24-month period whose election, or nomination for election by the stockholders of Odonate, was approved by a vote of at least a majority of the directors then comprising the incumbent board shall be considered as though such individual were a member of the incumbent board, but excluding, for this purpose, any such individual whose initial assumption of office occurs as a result of an actual or threatened election contest with respect to the election or removal of directors or other actual or threatened solicitation of proxies or consents by or on behalf of a person other than the Board.
Section 5.2 Right to Advancement of Expenses .
(a) In addition to the right to indemnification conferred in Section 5.1, an indemnitee shall, to the fullest extent permitted by law, also have the right to be paid by Odonate the expenses (including attorneys fees) incurred in defending any proceeding in advance of its final disposition (hereinafter an advancement of expenses ); provided , however , that an advancement of expenses shall be made only on delivery to Odonate of an undertaking (hereinafter an undertaking ), by or on behalf of such indemnitee, to repay all amounts so advanced if it shall ultimately be determined by final judicial decision of a court of competent jurisdiction from which there is no further right to appeal (hereinafter a final adjudication ) that such indemnitee is not entitled to be indemnified for such expenses under this Article or otherwise.
(b) To receive an advancement of expenses under this Section 5.2, an indemnitee shall submit a written request to the Secretary of Odonate. Such request shall reasonably evidence the expenses incurred by the indemnitee and shall include or be accompanied by the undertaking required by Section 5.2(a). Each such advancement of expenses shall be made within 20 days after the receipt by the Secretary of Odonate of a written request for advancement of expenses.
(c) Notwithstanding the foregoing Section 5.2(a), Odonate shall not make or continue to make advancements of expenses to an indemnitee (except by reason of the fact that the indemnitee is or was a director of Odonate, in which event this Section 5.2(c) shall not apply) if a determination is reasonably made that the facts known at the time such determination is made demonstrate clearly and convincingly that the indemnitee acted in bad faith or in a manner that the indemnitee did not reasonably believe to be in or not opposed to the best interests of Odonate, or, with respect to any criminal proceeding, that the indemnitee had reasonable cause to believe his or her conduct was unlawful. Such determination shall be made: (i) by the Board by a majority vote of directors who are not parties to such proceeding, whether or not such majority constitutes a quorum; (ii) by a committee of such directors designated by a majority vote of such directors, whether or not such majority constitutes a quorum; or (iii) if there are no such directors, or if such directors so direct, by independent legal counsel in a written opinion to the Board, a copy of which shall be delivered to the indemnitee.
Section 5.3 Right of Indemnitee to Bring Suit . In the event that a determination is made that the indemnitee is not entitled to indemnification or if payment is not timely made
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following a determination of entitlement to indemnification pursuant to Section 5.1(b) or if an advancement of expenses is not timely made under Section 5.2(b), the indemnitee may at any time thereafter bring suit against Odonate in a court of competent jurisdiction in the State of Delaware seeking an adjudication of entitlement to such indemnification or advancement of expenses. If successful in whole or in part in any such suit, or in a suit brought by Odonate to recover an advancement of expenses pursuant to the terms of an undertaking, the indemnitee shall be entitled to be paid also the expense of prosecuting or defending such suit to the fullest extent permitted by law. In any suit brought by the indemnitee to enforce a right to indemnification hereunder (but not in a suit brought by the indemnitee to enforce a right to an advancement of expenses) it shall be a defense that the indemnitee has not met any applicable standard of conduct for indemnification set forth in the DGCL. Further, in any suit brought by Odonate to recover an advancement of expenses pursuant to the terms of an undertaking, Odonate shall be entitled to recover such expenses on a final adjudication that the indemnitee has not met any applicable standard of conduct for indemnification set forth in the DGCL. Neither the failure of Odonate (including its directors who are not parties to such action, a committee of such directors, independent legal counsel or its stockholders) to have made a determination prior to the commencement of such suit that indemnification of the indemnitee is proper in the circumstances because the indemnitee has met the applicable standard of conduct set forth in the DGCL, nor an actual determination by Odonate (including its directors who are not parties to such action, a committee of such directors, independent legal counsel or its stockholders) that the indemnitee has not met such applicable standard of conduct, shall create a presumption that the indemnitee has not met the applicable standard of conduct or, in the case of such a suit brought by the indemnitee, be a defense to such suit. In any suit brought by the indemnitee to enforce a right to indemnification or to an advancement of expenses hereunder, or brought by Odonate to recover an advancement of expenses pursuant to the terms of an undertaking, the burden of proving that the indemnitee is not entitled to be indemnified, or to such advancement of expenses, under applicable law, this Article or otherwise shall be on Odonate.
Section 5.4 Non-Exclusivity of Rights . The rights to indemnification and to the advancement of expenses conferred in this Article shall not be exclusive of any other right which any person may have or hereafter acquire under any law, agreement, vote of stockholders or disinterested directors, provisions of a certificate of incorporation or bylaws, or otherwise.
Section 5.5 Insurance . Odonate may maintain insurance, at its expense, to protect itself and any director, officer, employee or agent of Odonate or another corporation, partnership, joint venture, trust or other enterprise against any expense, liability or loss, whether or not Odonate would have the power to indemnify such person against such expense, liability or loss under the DGCL.
Section 5.6 Indemnification of Employees and Agents of Odonate . Odonate may, to the extent and in the manner permitted by law, and to the extent authorized from time to time, grant rights to indemnification and to the advancement of expenses to any employee or agent of Odonate.
Section 5.7 Nature of Rights . The rights conferred on indemnitees in this Article shall be contract rights and such rights shall continue as to an indemnitee who has ceased to be a director or officer and shall inure to the benefit of the indemnitees heirs, executors and
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administrators. Any amendment, alteration or repeal of this Article that adversely affects any right of an indemnitee or its successors shall be prospective only and shall not limit or eliminate any such right with respect to any proceeding involving any occurrence or alleged occurrence of any action or omission to act that took place prior to such amendment, alteration or repeal.
Section 5.8 Settlement of Claims . Notwithstanding anything in this Article to the contrary, Odonate shall not be liable to indemnify any indemnitee under this Article for any amounts paid in settlement of any proceeding effected without Odonates written consent, which consent shall not be unreasonably withheld.
Section 5.9 Subrogation . In the event of payment under this Article, Odonate shall be subrogated to the extent of such payment to all of the rights of recovery of the indemnitee (excluding insurance obtained on the indemnitees own behalf), and the indemnitee shall execute all papers required and shall do everything that may be necessary to secure such rights, including the execution of such documents necessary to enable Odonate effectively to bring suit to enforce such rights.
Section 5.10 Severability . If any provision or provisions of this Article shall be held to be invalid, illegal or unenforceable as applied to any person or entity or circumstance for any reason whatsoever, then, to the fullest extent permitted by law: (a) the validity, legality and enforceability of such provision in any other circumstance and of the remaining provisions of this Article (including, without limitation, all portions of any paragraph of this Article containing any such provision held to be invalid, illegal or unenforceable, that are not by themselves invalid, illegal or unenforceable) and the application of such provision to other persons or entities or circumstances shall not in any way be affected or impaired thereby; and (b) to the fullest extent possible, the provisions of this Article (including, without limitation, all portions of any paragraph of this Article containing any such provision held to be invalid, illegal or unenforceable, that are not themselves invalid, illegal or unenforceable) shall be construed so as to give effect to the intent of the parties that Odonate provide protection to the indemnitee to the fullest extent set forth in this Article.
ARTICLE VI
CAPITAL STOCK
Section 6.1 Certificates of Stock . The shares of Odonate may be represented by certificates; provided, however, that the Board may also provide by resolution or resolutions that some or all stock shall be uncertificated shares. Any such resolution shall not apply to shares represented by a certificate until such certificate is surrendered to Odonate. Each holder of stock represented by certificates shall be entitled to a certificate signed by, or in the name of Odonate, by any two of the Chief Executive Officer, the Chief Financial Officer, the Secretary or any other authorized officers of Odonate, certifying the number of shares owned by him or her. Any or all of the signatures on the certificate may be by facsimile. Certificates representing stock, and any notice of issuance or transfer of uncertificated stock, shall comply with the applicable requirements of Sections 151, 156, 202(a) or 218(a) of the DGCL.
Section 6.2 Transfers of Stock . Transfers of stock shall be made only on the books of Odonate on authorization by the registered holder thereof or by such holders attorney thereunto
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authorized by a power of attorney duly executed and filed with the Secretary of Odonate or a transfer agent for such stock, and if such shares are represented by a certificate, on surrender of the certificate or certificates for such shares properly endorsed or accompanied by a duly executed stock transfer power and the payment of any taxes thereon; provided , however , that Odonate shall be entitled to recognize and enforce any lawful restriction on transfer.
Section 6.3 Registered Stockholders . Odonate shall be entitled to recognize the exclusive right of a person registered on its books as the owner of shares to receive dividends, and to vote as such owner, and shall not be bound to recognize any equitable or other claim to or interest in such share or shares on the part of any other person, whether or not it shall have express or other notice thereof, except as otherwise required by law.
Section 6.4 Record Date for Determining Stockholders . In order to permit Odonate to determine: (i) the stockholders entitled to notice of, and to vote at, any meeting of stockholders or any adjourned meeting; (ii) the stockholders entitled to express consent to corporate action in writing without a meeting; and (iii) the stockholders entitled to receive payment of any dividend or other distribution or allotment of any rights, or the stockholders entitled to exercise any rights in respect of any change, conversion or exchange of stock or for the purpose of any other lawful action, the Board may fix a record date in accordance with Section 213 of the DGCL.
Section 6.5 Regulations . To the extent permitted by applicable law, the Board may make such additional rules and regulations as it may deem expedient concerning the issue, transfer and registration of shares of stock of Odonate.
Section 6.6 Waiver of Notice . Whenever notice is required to be given under any provision of the DGCL or the Certificate of Incorporation or these Bylaws, the person entitled to notice may waive such notice in accordance with Section 229 of the DGCL.
ARTICLE VII
GENERAL MATTERS
Section 7.1 Fiscal Year . The fiscal year of Odonate shall begin on the first day of January of each year and end on the last day of December of the same year, or shall extend for such other 12 consecutive months as the Board may designate.
Section 7.2 Corporate Seal . The Board may provide a suitable seal, containing the name of Odonate, which seal shall be in the charge of the Secretary of Odonate. If and when so directed by the Board or a committee thereof, duplicates of the seal may be kept and used by the Treasurer or by an Assistant Secretary or Assistant Treasurer.
Section 7.3 Subject to Law and Certificate of Incorporation . All powers, duties and responsibilities provided for in these Bylaws, whether or not explicitly so qualified, are qualified by the Certificate of Incorporation and applicable law.
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ARTICLE VIII
AMENDMENTS
Section 8.1 Amendments . In accordance with the Certificate of Incorporation, the Board is expressly authorized to adopt, amend or repeal these Bylaws. In addition to any requirements of law, the affirmative vote of at least a majority of the voting power of the stock outstanding and entitled to vote thereon, voting together as a single class, shall be required for the stockholders to adopt, amend or repeal any provision of these Bylaws.
The foregoing Bylaws were adopted by the Board on , 2017.
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Exhibit 5.1
Gibson, Dunn & Crutcher LLP
555 Mission Street San Francisco, CA 94105-0921 Tel 415.393.8200 www.gibsondunn.com |
November 27, 2017
Odonate Therapeutics, LLC
4747 Executive Drive, Suite 510
San Diego, CA 92121
Re: | Odonate Therapeutics, LLC |
Registration Statement on Form S-1 (File No. 333-221533)
Ladies and Gentlemen:
We have examined the Registration Statement on Form S-1 (File No. 333-221533) (the Registration Statement ), of Odonate Therapeutics, LLC, a Delaware limited liability company, to be converted into Odonate Therapeutics, Inc., a Delaware corporation (the Company ), filed with the Securities and Exchange Commission (the Commission ) pursuant to the Securities Act of 1933, as amended (the Securities Act ), in connection with the offering by the Company of up to 6,762,000 shares (which includes shares that may be sold upon exercise of the underwriters option to purchase additional shares) of the Companys common stock (the Common Stock ), par value $0.01 per share (the Shares ).
In arriving at the opinion expressed below, we have examined originals, or copies certified or otherwise identified to our satisfaction as being true and complete copies of the originals, of corporate records, certificates of officers of the Company and of public officials and other instruments as we have deemed necessary or advisable to enable us to render the opinions set forth below. In our examination, we have assumed without independent investigation the genuineness of all signatures, the legal capacity and competency of all natural persons, the authenticity of all documents submitted to us as originals and the conformity to original documents of all documents submitted to us as copies.
Based upon the foregoing, and subject to the assumptions, exceptions, qualifications and limitations set forth herein, we are of the opinion that the Shares, when issued against payment therefor as set forth in the Registration Statement, will be validly issued, fully paid and non-assessable.
We consent to the filing of this opinion as an exhibit to the Registration Statement, and we further consent to the use of our name under the caption Legal Matters in the Registration Statement and the prospectus that forms a part thereof. In giving these consents, we do not thereby admit that we are within the category of persons whose consent is required under Section 7 of the Securities Act or the Rules and Regulations of the Commission.
Very truly yours,
/s/ Gibson, Dunn & Crutcher LLP
Beijing Brussels Century City Dallas Denver Dubai Frankfurt Hong Kong Houston London Los Angeles Munich
New York Orange County Palo Alto Paris San Francisco São Paulo Singapore Washington D.C.
Exhibit 10.1
LIMITED LIABILITY COMPANY AGREEMENT
OF
ODONATE HOLDINGS, LLC
This Limited Liability Company Agreement (this Operating Agreement ) of Odonate Holdings, LLC ( Odonate Holdings ) is made effective as of November 27, 2017 (the Effective Date ), with respect to the holders of Units (each a Member , and collectively, the Members ) .
Odonate Holdings and the Members agree as follows:
1. Purpose . Odonate Holdings may engage in any lawful act or activity in furtherance thereof, as permitted under the Act.
2. Powers . In furtherance of its purposes, but subject to all of the provisions of this Operating Agreement, Odonate Holdings shall have the power and is hereby authorized to do all things and engage in all such activities as may be necessary, convenient or incidental to the conduct of the business of Odonate Holdings, and have and exercise all of the powers and rights conferred upon limited liability companies formed pursuant to the Act.
3. Principal Business Office . The principal business office of Odonate Holdings shall be located at such location as may be determined by the Board of Directors.
4. Registered Office . The name and address of the registered agent of Odonate Holdings for service of process on Odonate Holdings in the State of Delaware, and the address of the registered office of Odonate Holdings in the State of Delaware, is Corporation Service Company, 2711 Centerville Road, Suite 400, Wilmington, New Castle County, Delaware, 19808.
5. Members . The names and mailing addresses of the Members shall be maintained in the records of Odonate Holdings at the principal business office of Odonate Holdings. The number of Units owned by each Member shall be maintained in the records of Odonate Holdings at the principal business office of Odonate Holdings, which shall be updated from time to time to reflect changes in the amount or ownership of the Units.
6. Limited Liability . Except as otherwise provided by the Act, the debts, obligations and liabilities of Odonate Holdings, whether arising in contract, tort or otherwise, shall be solely the debts, obligations and liabilities of Odonate Holdings, and the Members shall not be obligated personally for any such debt, obligation or liability of Odonate Holdings solely by reason of being a Member of Odonate Holdings.
7. Board of Directors .
(a) The business and affairs of Odonate Holdings shall be managed by or under the direction of a board of directors (the Board of Directors ), which may from time to time by resolution delegate authority to officers, employees or other agents to act on behalf of Odonate Holdings. The Board of Directors, acting with due authorization pursuant to this Section 7(a), shall have the power to do any and all acts necessary, convenient or incidental to or for the furtherance
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of the purposes of Odonate Holdings described herein, including all powers, statutory or otherwise, possessed by managers of a limited liability company under the laws of the State of Delaware. Each member of the Board of Directors (each, a Director ) is hereby designated a manager of Odonate Holdings within the meaning of the Act (a Manager ). Except as otherwise required by law, approval of any action by the Board of Directors (or approval by an agent delegated such approval authority by the Board of Directors) in accordance with the Operating Agreement shall constitute approval of such action by Odonate Holdings. Except as otherwise provided in this Operating Agreement, no Member or Director (acting alone and not collectively with the authority of the Board of Directors) shall have the authority to bind Odonate Holdings.
(b) The size of the Board of Directors may be fixed by a vote of the Directors or by the Members, acting by Unit Approval. As of the Effective Date, the size of the Board of Directors has been fixed at six Directors, with the Directors serving as of such date being: Kevin Tang, Jeffrey Vacirca, Aaron Davis, Craig Johnson, Robert Rosen, and George Tidmarsh, each to serve until his resignation or removal. The Members may appoint or remove any Director at any time by vote or consent of Members holding a majority of the Common Units of Odonate Holdings ( Unit Approval ). Any vacancy created with the removal of a Director shall be filled solely by a vote of the Members acting with Unit Approval. Vacancies created by the expansion of the number of Directors or by the resignation or retirement of a Director may be filled either by a vote of the Members acting with Unit Approval, or by a vote of the Board of Directors.
(c) A majority of the Directors then serving shall constitute a quorum, and a quorum shall be required to be present for the Board of Directors to take action at any meeting. At any meeting where a quorum is present, an action approved by the majority of the Directors present at such meeting (whether in person or via remote means of communication, such as telephone or video conferencing) shall constitute the approval of such action by the Board of Directors. The Board of Directors may also take action by written consent, executed or otherwise unanimously approved in writing (including via email) by all Directors then serving in office. Meetings of the Board of Directors may be called by any Director or by the Chief Executive Officer upon providing at least 24 hours prior notice of such meeting to all Directors, with such notice to be provided in person, by telephone or via email.
(d) Notwithstanding the foregoing, the Board of Directors shall be required to obtain Unit Approval prior to taking any of the following actions: (i) effecting any merger or consolidation in which the holders of the Units immediately prior to such transaction do not hold at least a majority of the voting interests of the surviving entity immediately after such transaction; (ii) the sale of all or substantially all of the assets of Odonate Holdings; or (iii) the liquidation or dissolution of Odonate Holdings.
(e) The Board of Directors shall have a fiduciary relationship with the Members and shall act at all times in accordance with such fiduciary duties. In defining the scope of such fiduciary duties, the Board of Directors duties to the Members shall be substantially similar to the duties owed by directors of a corporation to its stockholders under the Delaware General Corporation Law (including decisions by Delaware courts interpreting such law). Notwithstanding the foregoing, in no event shall the Board of Directors owe any fiduciary duties to creditors of the Company.
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8. Capitalization .
(a) Authorized Units . The capital of Odonate Holdings shall be represented by two classes of units: common units (the Common Units ) and incentive units (the Incentive Units and, together with the Common Units, the Units ) .
(b) Common Units . Common Units shall be issued in consideration for cash or non- cash contributions at such prices and on such other terms as the Board of Directors shall determine from time to time. Units may be issued in fractions going out to two decimal places. The amount of cash or other property or rights contributed by each Member to Odonate Holdings pursuant to this Section 8(b) (collectively, the Capital Contributions ) will be recorded on the books of Odonate Holdings.
(c) Incentive Units . The Incentive Units are intended to be issued, in such amounts and with such terms as determined by the Board of Directors in its sole discretion, to selected employees, Directors, consultants and other service providers and agents of Odonate Holdings or its affiliates, including to Odonate Management Holdings, LLC.
(i) Any Incentive Units awarded shall have set forth in a written agreement with the recipient (an Award Agreement ) a base price (the Base Price ) that shall be on a per Incentive Unit basis and shall not be less than the amount, on a per Unit basis, that would be received per Common Unit outstanding at the time of such grant, if, immediately after the issuance of such Incentive Units, all the assets of Odonate Holdings were sold for their respective fair values (as determined in good faith by the Board of Directors), the liabilities of Odonate Holdings were paid in full and the remaining proceeds were distributed in accordance with Section 15.
(ii) Notwithstanding anything contained herein or in the Act to the contrary, the Incentive Units shall have no voting, approval, information or consent rights.
(iii) Odonate Holdings and each Member shall: (A) treat each Incentive Unit as a profits interest within the meaning of Rev. Proc. 93-27, 1993-2C.B. 343, as clarified by Rev. Proc. 2001-43, 2001-2 C.B. 191; (B) treat each holder of an Incentive Unit as the owner of such interests from the date such interests are granted until such interests are forfeited or otherwise disposed of; (C) agree that each holder of an Incentive Unit will take into account such distributive share of Odonate Holdings income, gain, deduction and loss in computing its United States federal income tax liability for the entire period during which it holds such interests; and (D) agree that Odonate Holdings will not claim a deduction (as wages, compensation or otherwise) for the fair value of any Incentive Unit either upon grant or vesting of the Incentive Unit.
9. Capital Accounts; Allocation of Profits and Losses .
(a) Capital Accounts . A capital account for each Member shall be established and maintained in accordance with Section 704(b) of the Internal Revenue Code of 1986, as amended (the Code ) , and the regulations promulgated thereunder. Odonate Holdings net profit, net loss and items thereof shall be allocated to the capital accounts of the eligible Members on an annual basis, at the end of each calendar year, unless otherwise required by law or deemed advisable by the Board of Directors (and a period for which such allocations are made is referred
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to herein as an accounting period ).
(b) Allocation of Profits and Losses . Subject to Section 9(c), after all capital contributions and distributions for each accounting period have been reflected in the Members capital accounts, the net profit or net loss, if any, for each accounting period shall be credited to such Members capital accounts in such manner that as of the end of such accounting period, each Members capital account shall be equal to the respective net amounts, positive or negative, which would be distributed to them or for which they would be liable to Odonate Holdings under this Operating Agreement, determined as if Odonate Holdings were to liquidate all of the assets of Odonate Holdings for an amount equal to their fair value and distribute the proceeds of such liquidation in the manner described in Section 15. For purposes of calculating a Members capital account under this Section 9(b), any amounts such Member is obligated to restore (or deemed obligated to restore pursuant to the Treasury Regulations under Section 704(b) of the Code) shall be deemed to increase such Members capital account balance. For purposes of this Section 9(b), all unvested Incentive Units shall be treated as if they were vested.
(c) Regulatory and Special Allocations . Notwithstanding the allocations set forth in Section 9(b), Odonate Holdings net profit, net loss and items thereof shall be allocated to the Members in the manner and to the extent required by the Treasury Regulations under Section 704 of the Code, the provisions thereof dealing with minimum gain chargebacks, partner minimum gain chargebacks, qualified income offsets, partnership nonrecourse deductions, partner nonrecourse deductions, and the provisions dealing with deficit capital accounts in Sections 1.704-2(g)(1), 1.704-2(i)(5), and 1.704-1(b)(2)(ii)(d).
(d) Tax Allocations . The income, gains, losses, deductions and expenses of Odonate Holdings shall be allocated, for federal, state and local income tax purposes, among the Members in accordance with the allocation of such income, gains, losses, deductions and expenses among the Members for computing their capital accounts, except that if any such allocation is not permitted by the Code or other applicable law, Odonate Holdings subsequent income, gains, losses, deductions and expenses shall be allocated among the Members for tax purposes to the extent permitted by the Code and other applicable law, so as to reflect as nearly as possible the allocation set forth herein in computing their capital accounts. Notwithstanding the previous sentence, such tax items shall be allocated among the Members in a different manner to the extent required by Code Section 704(c) and the Treasury Regulations thereunder (dealing with contributed property), Treasury Regulations Sections 1.704-1(b)(2)(1) (dealing with property having a book value different than its tax basis), and 1.704-1(b)(4)(ii) (dealing with tax credit items). Allocations pursuant to this Section 9(d) are solely for purposes of federal, state and local taxes and shall not affect, or in any way be taken into account in computing, any Members capital account or share of profits, losses, other items or distributions pursuant to any provisions of this Operating Agreement.
(e) Pass-Through Taxation . Prior to allocating any taxable income to the Members, Odonate Holdings shall take such actions to either: (a) change to a non-pass through entity ( e.g. , a corporation) in order to prevent any Members from incurring, or otherwise recognizing, any unrelated business taxable income; or (b) as requested by a Member, insert a blocker entity for tax purposes.
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(f) Tax Matters Partner . Tang Capital Partners II, LP shall be the tax matters partner for purposes of Code Section 6231. The tax matters partner may be removed and replaced by the Members, subject to obtaining Unit Approval. As tax matters partner, Tang Capital Partners II, LP covenants and agrees with the Members that, without obtaining Unit Approval: (i) after the receipt of a final partnership administrative adjustment for a taxable year, Tang Capital Partners II, LP will not file a petition for readjustment of the partnership items , within the meaning of Section 6226 of the Code, in any court other than the United States Tax Court; and (ii) Tang Capital Partners II, LP will not agree, pursuant to Section 6229(b)(1)(B) of the Code, to extend the period for assessing any tax imposed by subtitle A of the Code with respect to any Member that any item (or affected items) of Odonate Holdings is attributable to.
10. Distributions .
(a) General . Distributions may be made to the Members at the times and in the amounts determined by the Board of Directors. Such distributions shall be made to the Members in proportion to their ratable holdings of Units as compared to the number of total Units outstanding (subject to Section 10(b)) ; provided that no distribution shall be made to a Member to the extent it would cause such Member to have a deficit capital account.
(b) Incentive Units Adjustment . For the purposes of any distributions made under this Section 11(a) or 16, an Incentive Unit shall not be considered outstanding until the aggregate distributions made to the Common Unit holders, on a per-Common Unit basis, since the grant of such Incentive Unit equal the Base Price for such Incentive Unit.
(c) Unvested Incentive Units . Notwithstanding the foregoing, for the purposes of making any distributions pursuant to this Section 10, no Incentive Unit shall be entitled to receive a distribution while it is unvested pursuant to the terms of the Award Agreements thereunder. Instead, the distributions that would otherwise be made on such unvested Incentive Units will be credited to a memorandum account and, subject to such Incentive Units becoming vested, distributed at the time of the next distribution to the Common Units pursuant to Section 10(a).
(d) Property Distributions . At the sole discretion of the Board of Directors, Odonate Holdings may make in-kind distributions of its property, including any publicly traded stock.
11. Other Business . The Members, Manager, and any person or entity affiliated with the Members or Manager may engage in or possess an interest in other business ventures (unconnected with Odonate Holdings) of every kind and description, independently or with others. Odonate Holdings shall not have any rights in or to such independent ventures or the income or profits therefrom by virtue of this Operating Agreement.
12. Exculpation and Indemnification .
(a) Member Exculpation and Indemnification .
(i) No Member, its affiliates or any of their current or former officers, directors, trustees, members, employees, representatives, attorneys or agents (collectively, Member Indemnified Parties , and each individually, a Member Indemnified Party ) shall, by
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virtue of such Members status as a Member, have any liability to any other person under the Certificate of Formation, this Operating Agreement or any applicable law, except liability to Odonate Holdings, the other Members and the tax matters partner in respect of obligations expressly arising hereunder or required by law.
(ii) No Member shall in any event have any liability whatsoever (except as expressly required by the Act) in excess of the following (without duplication): (A) the amount of any Capital Contribution previously made by such Member; (B) its share of any assets and undistributed profits of Odonate Holdings; and (C) the amount of any wrongful distribution to such Member, if, and only to the extent, such Member had actual knowledge (at the time of the distribution) that such distribution was made in violation of the Act or this Operating Agreement.
(iii) To the fullest extent permitted by law, in any threatened, pending or completed action, suit or proceeding brought by a person other than a Member, an affiliate of a Member or Odonate Holdings, each Member Indemnified Party shall be fully protected and indemnified and held harmless by Odonate Holdings against all Damages actually incurred by such Member Indemnified Party in connection with such action, suit or proceeding by virtue of the relevant Members status as a Member or with respect to any action or omission taken or suffered in good faith by it in connection with the relevant Members status as a Member. The preceding sentence shall not apply to Damages resulting from the bad faith, fraud or willful misconduct of such Member Indemnified Party. Damages means any liabilities, obligations, losses, damages, penalties, actions, judgments, suits, proceedings, costs, expenses and disbursements of any kind or nature whatsoever (including reasonable attorneys fees, costs of investigation, fines, judgments and amounts paid in settlement).
(iv) The indemnification provided by this Section 12(a) shall be recoverable only out of the assets of Odonate Holdings, and no Member shall have any personal liability (or obligation to contribute capital to Odonate Holdings or make any other financial accommodation available) on account thereof. No amendment to this Section 12(a) will impair the rights of any person arising at any time with respect to events occurring prior to such amendment.
(b) Director Exculpation and Indemnification .
(i) No Director, officer or employee of Odonate Holdings (collectively, the D&O Indemnified Parties , and each individually, a D&O Indemnified Party ) shall, in such persons capacity as such a Director, officer or employee, have any liability to any other person (other than Odonate Holdings and its Members) under the Certificate of Formation, this Operating Agreement or any applicable law, except as otherwise expressly provided for herein or required by such law.
(ii) No D&O Indemnified Party will be liable, responsible or accountable for Damages or otherwise to: (A) Odonate Holdings or to any Member or its affiliates; (B) any direct or indirect equity holder of Odonate Holdings or any Member or its affiliates; or (C) any direct or indirect holder of a claim against Odonate Holdings or any Member or its affiliates, for: (i) any action or omission taken or suffered within the scope of the authority conferred on such person by this Operating Agreement or any other agreement between the applicable Director, officer or employee and Odonate Holdings, except for the fraud or intentional misconduct of such person in carrying out such persons obligations hereunder; (ii) such persons performance of, or failure to perform, any act in reasonable reliance on the advice of legal counsel to Odonate
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Holdings; or (iii) the negligence, dishonesty or bad faith of any agent, consultant, professional or broker of Odonate Holdings selected, engaged or retained in good faith by Odonate Holdings.
(iii) To the fullest extent permitted by law, in any threatened, pending or completed action, suit or proceeding, each D&O Indemnified Party shall be fully protected and indemnified and held harmless by Odonate Holdings against all Damages actually incurred by such D&O Indemnified Party in connection with such action, suit or proceeding by virtue of its status as a D&O Indemnified Party or with respect to any action or omission taken or suffered by such D&O Indemnified Party as such; provided, that the relevant D&O Indemnified Party: (A) acted in a manner such person reasonably believed to be in, or not opposed to, the best interests of Odonate Holdings; (B) did not believe to be in violation of the terms of this Operating Agreement; and (C) with respect to any criminal proceeding, had no reasonable cause to believe that his or her conduct was unlawful.
(iv) The indemnification provided by this Section 12(b) shall be recoverable only out of the assets of Odonate Holdings, and no Member shall have any personal liability (or obligation to contribute capital to Odonate Holdings or make any other financial accommodation available) on account thereof. In addition, a majority of the Board of Directors, acting in its sole discretion, may from time to time extend the indemnification and advancement of expenses provided by this Section 12(b) to one or more agents of Odonate Holdings; in each case on the basis set forth herein applicable to D&O Indemnified Parties.
(c) Any indemnification under Section 12(a) and 12(b) will be made by Odonate Holdings unless there has been a final and unappealable determination by a court of competent jurisdiction in the specific case that indemnification of the person requesting indemnification is not proper in the circumstances because the relevant person has not met the applicable standard of conduct set forth in this Operating Agreement.
(d) Damages suffered by a person entitled to indemnification pursuant to Sections 12(a) or 12(b) may be paid (and, in the case of an agent, may be paid if so determined by the Board of Directors) by Odonate Holdings from time to time as incurred and in advance of the final disposition of such matter upon receipt of a written undertaking by or on behalf of such person to repay amounts paid if it is ultimately determined that such person is not entitled to be indemnified by Odonate Holdings as authorized in Sections 12(a) and 12(b) or, where indemnification is authorized, to the extent amounts paid exceed the amount to which such person is entitled.
(e) The rights provided to any person by Sections 12(a) and 12(b) will be enforceable against Odonate Holdings by such person and each such person being presumed to have relied upon such rights in serving or continuing to serve Odonate Holdings. No amendment to this Section 12(e) will impair the rights of any person arising at any time with respect to events occurring prior to such amendment. For purposes of Sections 12(a) and 12(b), the term Odonate Holdings includes any constituent person (including any constituent of a constituent) absorbed by Odonate Holdings in a consolidation or merger.
(f) Nothing in this Section 12 will limit or affect any other right of any person indemnified hereunder to indemnification or reimbursement of damages under any other provision of this Operating Agreement or any provision of any other agreement (including any insurance policy), any organizational document, any statute, rule or regulation or otherwise.
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(g) The provisions of this Section 12 shall survive the dissolution of Odonate Holdings, the withdrawal of a Member from Odonate Holdings and the resignation or removal of any Director, officer or employee of Odonate Holdings.
(h) If this Section 12 or any portion hereof shall be invalidated on any ground by any court or other governmental authority of competent jurisdiction, then Odonate Holdings shall nevertheless indemnify and hold harmless each person indemnified pursuant to this Section 12 as to costs, charges and expenses (including reasonable attorneys fees), judgments, fines and amounts paid in settlement with respect to any such proceeding, appeal, inquiry or investigation to the full extent permitted by any applicable portion of this Section 12 that shall not have been invalidated and to the fullest extent permitted by applicable law.
13. Assignments .
(a) A Member may not assign in whole or in part his, her or its interest in Odonate Holdings without receiving prior written consent from the Board of Directors, which consent shall not be unreasonably withheld.
(b) Notwithstanding anything in the above Section 13(a), a member may transfer any Units owned by such Member to its affiliates or investment funds managed by such Member or its affiliates without consent from the Board of Directors.
(c) Any transfer or assignment permitted by this Section 13 shall be subject in all respects to the transferee executing a joinder to this Operating Agreement and furnishing notice of such transfer or assignment to the Board of Directors.
14. Admission of Additional Members . One or more additional Members of Odonate Holdings may be admitted to Odonate Holdings by approval of the Board of Directors.
15. Dissolution . Odonate Holdings shall dissolve, and its affairs shall be wound up upon: (i) approval of the Board of Directors, acting with Unit Approval; or (ii) the entry of a decree of judicial dissolution under the Act. In the event of dissolution, Odonate Holdings shall conduct only such activities as are necessary to wind up its affairs (including the sale of the assets of Odonate Holdings in an orderly manner), and, after giving effect to allocations, if any, pursuant to Section 10, the assets of Odonate Holdings shall be distributed to the Members in accordance with their respective capital account balances.
16. Certificate . The Board of Directors has been designated as Odonate Holdings authorized person within the meaning of the Act. The Board of Directors shall execute, deliver and file any other certificates (and any amendments and/or restatements thereof) necessary for Odonate Holdings to qualify to do business in any jurisdiction in which the Board of Directors deems necessary or advisable.
17. Reparability of Provisions . Each provision of this Operating Agreement shall be considered separable and if for any reason any provision or provisions herein are determined to be invalid, unenforceable or illegal under any existing or future law, such invalidity, unenforceability or illegality shall not impair the operation of or affect those portions of this Operating Agreement which are valid, enforceable and legal.
18. Counterparts . This Operating Agreement may be executed in any number of
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counterparts, each of which shall be deemed an original of this Operating Agreement.
19. Entire Agreement . This Operating Agreement constitutes the entire agreement between the parties hereto with respect to the subject matter hereof, and supersedes all prior understandings or agreements between the parties.
20. No Third-party Beneficiaries . Except as set forth in Section 12, this Operating Agreement is not intended and shall not be construed as granting any rights, benefits or privileges to any person not a party to this Operating Agreement. Without limiting the generality of the foregoing, no creditor of Odonate Holdings or of any Member shall have any right whatsoever to require any Member to contribute capital, perform services for or on behalf of, or make a financial accommodation for or on behalf of Odonate Holdings.
21. Governing Law . This Operating Agreement shall be governed by, and construed under, the laws of the State of Delaware (without regard to conflict of laws principles), all rights and remedies being governed by said laws.
22. Market Stand-off . In the event that Odonate Holdings (or any successor or parent entity thereto) registers and sells any equity securities under the U.S. Securities Act of 1933 on a registration statement on Form S-1 in an initial public offering ( IPO ), then, no Member will, without the prior written consent of the managing underwriter of the IPO, during the period commencing on the date of the final prospectus relating to the IPO, and ending on the date specified by the Board of Directors and the managing underwriter (such period not to exceed one hundred eighty (180) days (or longer, up to an additional 35 days, if mutually agreed to by the managing underwriter and the Board of Directors)): (i) sell; contract to sell; sell any option or contract to purchase; purchase any option or contract to sell; grant any option, right, or warrant to purchase; lend; offer; pledge; or otherwise transfer or dispose of, directly or indirectly, any Units or shares of the Odonate Holdings (or any successor or parent entity thereto) common stock or any securities convertible into or exercisable or exchangeable (directly or indirectly) for such securities (the Covered Securities ); or (ii) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of any Covered Securities, whether any such transaction described in clause (i) or (ii) above is to be settled by delivery of Covered Securities or other securities, in cash, or otherwise. The foregoing provisions of this Section 22 shall not apply to: (i) Common Units purchased by a Member on the open market following the IPO or Common Units acquired by a Member in the IPO; or (ii) the transfer of any shares to any trust for the direct or indirect benefit of the Member or the immediate family of the Member, provided that, in the case of clause (ii), the trustee of the trust agrees to be bound in writing by the restrictions set forth herein, and provided further that any such transfer shall not involve a disposition for value, and shall be applicable to the Members only if all officers and directors are subject to the same restrictions. The foregoing provisions of this Section 22 shall not apply to bona-fide gifts made to private and/or public charities and foundations. The underwriters in connection with such registration are intended third-party beneficiaries of this Section 22 and shall have the right, power and authority to enforce the provisions hereof as though they were a party hereto. Each Member further agrees to execute such agreements as may be reasonably requested by the underwriters in connection with such registration that are consistent with this Section 22 or that are necessary to give further effect thereto.
23. Amendments . This Operating Agreement may not be modified, altered, supplemented or amended except by receiving Unit Approval.
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IN WITNESS WHEREOF, the undersigned, intending to be legally bound hereby, has duly executed this Operating Agreement, and such execution shall represent the consent and approval required to amend and restate this Operating Agreement, effective as of the Effective Date.
TANG CAPITAL PARTNERS II, LP | ||||
By: Tang Capital Management II, LLC, its general partner
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By: /s/ Kevin C. Tang
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Name: Kevin C. Tang | ||||
Title: Authorized Signatory |
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IN WITNESS WHEREOF, the undersigned, intending to be legally bound hereby, has duly executed this Operating Agreement, and such execution shall represent the consent and approval required to amend and restate this Operating Agreement, effective as of the Effective Date.
TCPIL BL, LLC | ||
By: | /s/ Kevin C. Tang | |
Name: Kevin C. Tang | ||
Title: Authorized Signatory |
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Exhibit 10.2
ODONATE THERAPEUTICS, INC.
2017 STOCK OPTION PLAN
1. | Purpose . |
The purpose of this Odonate Therapeutics, Inc. 2017 Stock Option Plan (the Plan ) is to promote and closely align the interests of employees, officers, non-employee directors and other service providers of Odonate Therapeutics, Inc. ( Odonate ) and Odonates stockholders by providing stock-based compensation.
2. | Definitions . |
As used in the Plan, the following terms shall have the meanings set forth below:
(a) Affiliate means any entity in which Odonate has a substantial direct or indirect equity interest, as determined by the Committee from time to time.
(b) Act means the Securities Exchange Act of 1934, as amended, or any successor thereto.
(c) Beneficial Owner shall have the meaning set forth in Rule 13d-3 under the Act.
(d) Board means the board of directors of Odonate.
(e) Cause has the meaning set forth in a Grant Notice or other written employment or services agreement between the Participant and Odonate or an Affiliate thereof, or if no such meaning applies, means with respect to a Participant, the occurrence of any of the following events: (i) such Participants commission of any felony or any crime involving fraud, dishonesty or moral turpitude under the laws of the United States or any state thereof; (ii) such Participants attempted commission of, or participation in, a fraud or act of dishonesty against Odonate or its affiliates; (iii) such Participants intentional, material violation of any contract or agreement between the Participant and Odonate or of any statutory duty owed to Odonate or its affiliates; (iv) such Participants unauthorized use or disclosure of Odonates or its affiliates confidential information or trade secrets; or (v) such Participants gross misconduct. The determination that a Participants Separation from Service is either for Cause or without Cause shall be made by the Administrator in its sole discretion. Any determination by the Administrator that a Participants Separation from Service was by reason of dismissal without Cause for the purposes of the Plan shall have no effect upon any determination of the rights or obligations of Odonate or such Participant for any other purpose. A Participants employment or service will be deemed to have been terminated for Cause if it is determined subsequent to his or her termination of employment or service that grounds for termination of his or her employment or service for Cause existed at the time of his or her termination of employment or service.
(f) Change in Control means: (i) the merger, consolidation or sale or other transfer of outstanding shares of Common Stock of Odonate in a single transaction or a series of
related transactions, in each case in which the holders of outstanding Common Stock of Odonate immediately prior to such transaction do not hold at least a majority of the shares of stock or other voting equity interests of the surviving entity immediately after such transaction; (ii) the sale of all or substantially all of the assets of Odonate; or (iii) the liquidation or dissolution of Odonate, in each case as determined by the Administrator in its reasonable discretion.
(g) Code means the Internal Revenue Code of 1986, as amended from time to time, and the rulings and regulations issued thereunder.
(h) Committee means the Compensation Committee of the Board (or any successor committee), or the officer, officers or committee as designated by the Board to administer the Plan under Section 6.
(i) Common Stock means the common stock of Odonate, par value $0.01 per share, or any securities into which such Common Stock may be converted.
(j) Company means Odonate Therapeutics, Inc., a Delaware corporation, and except as utilized in the definition of Change in Control, any successor corporation.
(k) Disability means the Participants inability to perform his or her duties under the agreement under which the Participant provides services to Odonate or an affiliate, even with reasonable accommodation, because the Participant has become permanently disabled within the meaning of any policy of disability income insurance covering employees of Odonate then in force. In the event Odonate has no policy of disability income insurance covering employees of Odonate in force when the Participant becomes disabled, the term Disability shall mean the Participants inability to perform his or her duties under the agreement under which the Participant provides services to Odonate, whether with or without reasonable accommodation, by reason of any incapacity, physical or mental, which the Administrator, based upon medical advice or an opinion provided by a licensed physician acceptable to the Administrator, determines to have incapacitated the Participant from satisfactorily performing all of his or her usual services for Odonate, with or without reasonable accommodation, for a period of at least 6 consecutive months during any 12 month period. Based upon such medical advice or opinion, the determination of the Administrator shall be final and binding and the date such determination is made shall be the date of such Disability for purposes of this Plan.
(l) Effective Date means the date on which the Plan takes effect, as defined pursuant to Section 4 of the Plan.
(m) Eligible Person any current or prospective employee, officer, non-employee director or other service provider of Odonate or any of its Subsidiaries; provided however that Incentive Stock Options may only be granted to employees.
(n) Fair Market Value means as of any date, the value of the Common Stock determined as follows: (i) if the Common Stock is listed on any established stock exchange, system or market, its Fair Market Value shall be the closing price for the Common Stock as quoted on such exchange, system or market as reported in the Wall Street Journal or such other source as the Committee deems reliable (or, if no sale of Common Stock is reported for such date, on the next preceding date on which any sale shall have been reported); and (ii) in
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the absence of an established market for the Common Stock, the Fair Market Value thereof shall be determined in good faith by the Committee by the reasonable application of a reasonable valuation method, taking into account factors consistent with Treas. Reg. § 409A-1(b)(5)(iv)(B) as the Committee deems appropriate.
(o) Incentive Stock Option means a stock option that is intended to qualify as an incentive stock option within the meaning of Section 422 of the Code.
(p) Nonqualified Stock Option means a stock option that is not intended to qualify as an incentive stock option within the meaning of Section 422 of the Code.
(q) Option means a right to purchase a number of shares of Common Stock at such exercise price, at such times and on such other terms and conditions as are specified in or determined pursuant to a Grant Notice. Options granted pursuant to the Plan may be Incentive Stock Options or Nonqualified Stock Options.
(r) Grant Notice means a written or electronic agreement or other instrument as may be approved from time to time by the Committee and designated as such implementing the grant of each Option. A Grant Notice may be in the form of an agreement to be executed by both the Participant and Odonate (or an authorized representative of Odonate) or certificates, notices or similar instruments as approved by the Committee and designated as such.
(s) Participant means any Eligible Person to whom Options have been granted from time to time by the Committee and any authorized transferee of such individual.
(t) Person shall have the meaning given in Section 3(a)(9) of the Act, as modified and used in Sections 13(d) and 14(d) thereof, except that such term shall not include: (i) Odonate or any of its Affiliates; (ii) a trustee or other fiduciary holding securities under an employee benefit plan of Odonate or any of its Subsidiaries; (iii) an underwriter temporarily holding securities pursuant to an offering of such securities; or (iv) a corporation owned, directly or indirectly, by the stockholders of Odonate in substantially the same proportions as their ownership of stock of Odonate.
(u) Plan means the Odonate Therapeutics, Inc. 2017 Stock Option Plan as set forth herein and as amended from time to time.
(v) Separation from Service or Separates from Service means the termination of Participants employment with Odonate and all Subsidiaries that constitutes a separation from service within the meaning of Section 409A of the Code.
(w) Subsidiary means any business entity (including a limited liability company, corporation or a partnership) in which Odonate owns (either directly or indirectly through one or more other Subsidiaries) 50% or more of the total combined voting power of all classes of outstanding equity interests.
(x) Substitute Options means Options granted or Common Stock issued by Odonate in assumption of, or in substitution or exchange for, awards previously granted, or the
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right or obligation to make future awards, by a company acquired by Odonate or any Subsidiary or with which Odonate or any Subsidiary combines.
(y) Termination of Employment means ceasing to serve as an employee of Odonate and its Subsidiaries or, with respect to a non-employee director or other service provider, ceasing to serve as such for Odonate and its Subsidiaries, except that with respect to all or any Options held by a Participant: (i) the Committee may determine that a leave of absence or employment on a less than full-time basis is considered a Termination of Employment; (ii) the Committee may determine that a transition of employment to service with a partnership, joint venture or corporation not meeting the requirements of a Subsidiary in which Odonate or a Subsidiary is a party is not considered a Termination of Employment; (iii) service as a member of the Board shall constitute continued employment with respect to Options granted to a Participant while he or she served as an employee; and (iv) service as an employee of Odonate or a Subsidiary shall constitute continued employment with respect to Options granted to a Participant while he or she served as a member of the Board or other service provider. The Committee shall determine whether any corporate transaction, such as a sale or spin-off of a division or subsidiary that employs or engages a Participant, shall be deemed to result in a Termination of Employment with Odonate and its Subsidiaries for purposes of any affected Participants Options, and the Committees decision shall be final and binding.
3. Eligibility . |
Any Eligible Person is eligible for selection by the Committee to receive an Option.
4. | Effective Date and Termination of Plan . |
This Plan shall become effective on December [ ], 2017 (the Effective Date ). The Plan shall remain available for the grant of Options until the 10th anniversary of the Effective Date. Notwithstanding the foregoing, the Plan may be terminated at such earlier time as the Board may determine. Termination of the Plan will not affect the rights and obligations of the Participants and Odonate arising under Options theretofore granted.
5. | Shares Subject to the Plan and to Options . |
(a) Aggregate Limits . The aggregate number of shares of Common Stock underlying Options issuable under the Plan shall be equal to 4,800,000 (the Plan Reserve ). The aggregate number of shares of Common Stock underlying Options available for grant under this Plan and the number of shares of Common Stock subject to Options outstanding at the time of any event described in Section 10 shall be subject to adjustment as provided in Section 10. The shares of Common Stock issued pursuant to Options granted under this Plan may be shares that are authorized and unissued or shares that were reacquired by Odonate, including shares purchased in the open market.
(b) Issuance of Shares . For purposes of Section 5(a), the aggregate number of shares of Common Stock issued under this Plan at any time shall equal only the number of shares of Common Stock actually issued upon exercise of an Option. Shares of Common Stock subject to Options that have been canceled, expired, forfeited or otherwise not issued under an Option shall not count as shares of Common Stock issued under this Plan. The aggregate number of
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shares available for issuance under this Plan at any time shall not be reduced by: (i) shares subject to Options that have been terminated, expired unexercised, forfeited or settled in cash; (ii) shares subject to Options that have been retained or withheld by Odonate in payment or satisfaction of the exercise price or tax withholding obligation of an Option; or (iii) shares subject to Options that otherwise do not result in the issuance of shares in connection with payment or settlement thereof. In addition, shares that have been delivered (either actually or by attestation) to Odonate in payment or satisfaction of the exercise price or tax withholding obligation of an Option shall be available for issuance under this Plan.
(c) Substitute Options . Substitute Options shall not reduce the shares of Common Stock authorized for issuance under the Plan or authorized for grant to a Participant in any calendar year. Additionally, in the event that a company acquired by Odonate or any Subsidiary, or with which Odonate or any Subsidiary combines, has shares available under a pre-existing plan approved by stockholders and not adopted in contemplation of such acquisition or combination, the shares available for grant pursuant to the terms of such pre-existing plan (as adjusted, to the extent appropriate, using the exchange ratio or other adjustment or valuation ratio or formula used in such acquisition or combination to determine the consideration payable to the holders of common stock of the entities party to such acquisition or combination) may be used for Options under the Plan and shall not reduce the shares of Common Stock authorized for issuance under the Plan; provided that Options using such available shares shall not be made after the date awards or grants could have been made under the terms of the pre-existing plan, absent the acquisition or combination, and shall only be made to individuals who were employees of such acquired or combined company before such acquisition or combination.
(d) Tax Code Limits . The aggregate number of shares of Common Stock that may be issued pursuant to the exercise of Incentive Stock Options granted under this Plan shall be equal to the Plan Reserve, which number shall be adjusted pursuant to Section 10 only to the extent that such adjustment will not affect the status of any option intended to qualify as an Incentive Stock Option under Section 422 of the Code.
(e) Limits on Options to Non-Employee Directors. The aggregate dollar value of equity-based (based on the grant date fair value of Options) and cash compensation granted under this Plan or otherwise during any calendar year to any non-employee director shall not exceed $500,000; provided, however, that in the calendar year in which a non-employee director first joins the Board or is first designated as Chairman of the Board or lead independent director, the maximum aggregate dollar value of equity-based and cash compensation granted to the non-employee director may be up to 200% of the foregoing limit.
6. | Administration of the Plan . |
(a) Administrator of the Plan . The Plan shall be administered by the Committee. Any power of the Committee may also be exercised by the Board, except to the extent that the grant or exercise of such authority would cause any Option or transaction to become subject to (or lose an exemption under) the short-swing profit recovery provisions of Section 16 of the Act or cause an Option intended to qualify as performance-based compensation under Section 162(m) of the Code not to qualify for such treatment. To the extent that any permitted action taken by the Board conflicts with action taken by the Committee, the Board
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action shall control. To the maximum extent permissible under applicable law, the Committee (or any successor) may by resolution delegate any or all of its authority to one or more subcommittees composed of one or more directors and/or officers of Odonate, and any such subcommittee shall be treated as the Committee for all purposes under this Plan. Notwithstanding the foregoing, if the Board or the Committee (or any successor) delegates to a subcommittee comprised of one or more officers of Odonate (who are not also directors) the authority to grant Options, the resolution so authorizing such subcommittee shall specify the total number of shares of Common Stock such subcommittee may award pursuant to such delegated authority, and no such subcommittee shall designate any officer serving thereon or any executive officer or non-employee director of Odonate as a recipient of any Options granted under such delegated authority. The Committee hereby delegates to and designates the Chief Financial Officer of Odonate (or such other officer with similar authority), and to his or her delegates or designees, the authority to assist the Committee in the day-to-day administration of the Plan and of Options granted under the Plan, including without limitation those powers set forth in Section 6(b)(iv) through (ix) and to execute agreements evidencing Options made under this Plan or other documents entered into under this Plan on behalf of the Committee or Odonate. The Committee may further designate and delegate to one or more additional officers or employees of Odonate or any subsidiary, and/or one or more agents, authority to assist the Committee in any or all aspects of the day-to-day administration of the Plan and/or of Options granted under the Plan.
(b) Powers of Committee . Subject to the express provisions of this Plan, the Committee shall be authorized and empowered to do all things that it determines to be necessary or appropriate in connection with the administration of this Plan, including, without limitation:
(i) to prescribe, amend and rescind rules and regulations relating to this Plan and to define terms not otherwise defined herein;
(ii) to determine which persons are Eligible Persons, to which of such Eligible Persons, if any, Options shall be granted hereunder and the timing of any such Options;
(iii) to prescribe and amend the terms of the Grant Notices, to grant Options and determine the terms and conditions thereof;
(iv) to establish and verify the extent of satisfaction of any performance goals or other conditions applicable to the grant, issuance, retention, vesting, exercisability or settlement of any Option;
(v) to prescribe and amend the terms of or form of any document or notice required to be delivered to Odonate by Participants under this Plan;
(vi) to determine the extent to which adjustments are required pursuant to Section 10;
(vii) to interpret and construe this Plan, any rules and regulations under this Plan and the terms and conditions of any Option granted hereunder, and to make exceptions to any such provisions if the Committee, in good faith, determines that it is appropriate to do so;
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(viii) to approve corrections in the documentation or administration of any Option; and
(xi) to make all other determinations deemed necessary or advisable for the administration of this Plan.
Notwithstanding anything in this Plan to the contrary, the Committee shall exercise its discretion in a manner that causes Options granted under the Plan to be compliant with or exempt from the requirements of Section 409A of the Code section. Without limiting the foregoing, unless expressly agreed to in writing by the Participant holding such Option, the Committee shall not take any action with respect to any Option that constitutes: (i) a modification of a stock right within the meaning of Treas. Reg. § 1.409A-1(b)(5)(v)(B) so as to constitute the grant of a new stock right; (ii) an extension of a stock right, including the addition of a feature for the deferral of compensation within the meaning of Treas. Reg. § 1.409A-1 (b)(5)(v)(C); or (iii) an impermissible acceleration of a payment date or a subsequent deferral of a stock right subject to Section 409A of the Code within the meaning of Treas. Reg. § 1.409A-1(b)(5)(v)(E).
The Committee may, in its sole and absolute discretion, without amendment to the Plan but subject to the limitations otherwise set forth in Section 14, waive or amend the operation of Plan provisions respecting exercise after termination of employment or service to Odonate or an Affiliate. The Committee or any member thereof may, in its sole and absolute discretion and, except as otherwise provided in Section 14, waive, settle or adjust any of the terms of any Option so as to avoid unanticipated consequences or address unanticipated events (including any temporary closure of an applicable stock exchange, disruption of communications or natural catastrophe).
(c) Determinations by the Committee . All decisions, determinations and interpretations by the Committee regarding the Plan, any rules and regulations under the Plan and the terms and conditions of or operation of any Option granted hereunder, shall be final and binding on all Participants, beneficiaries, heirs, assigns or other persons holding or claiming rights under the Plan or any Option. The Committee shall consider such factors as it deems relevant, in its sole and absolute discretion, to making such decisions, determinations and interpretations including, without limitation, the recommendations or advice of any officer or other employee of Odonate and such attorneys, consultants and accountants as it may select. Members of the Board and members of the Committee acting under the Plan shall be fully protected in relying in good faith upon the advice of counsel and shall incur no liability except for gross negligence or willful misconduct in the performance of their duties.
(d) Subsidiary Awards . In the case of a grant of an Option to any Participant employed by a Subsidiary, such grant may, if the Committee so directs, be implemented by Odonate issuing any subject shares of Common Stock to the Subsidiary, for such lawful consideration as the Committee may determine, upon the condition or understanding that the Subsidiary will transfer the shares of Common Stock to the Participant in accordance with the terms of the Option specified by the Committee pursuant to the provisions of the Plan. Notwithstanding any other provision hereof, such Option may be issued by and in the name of the Subsidiary and shall be deemed granted on such date as the Committee shall determine.
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7. | Plan Awards . |
(a) Terms Set Forth in Grant Notice . Options may be granted to Eligible Persons as determined by the Committee at any time and from time to time prior to the termination of the Plan. The terms and conditions of each Option shall be set forth in a Grant Notice in a form approved by the Committee for such Option, which Grant Notice may contain such terms and conditions as specified from time to time by the Committee, provided such terms and conditions do not conflict with the Plan. The Grant Notice for any Option shall include the time or times at or within which and the consideration, if any, for which any shares of Common Stock may be acquired from Odonate. The terms of Options may vary among Participants, and the Plan does not impose upon the Committee any requirement to make Options subject to uniform terms. Accordingly, the terms of individual Grant Notices may vary.
(b) Termination of Employment . Subject to the express provisions of the Plan, the Committee shall specify before, at or after the time of grant of an Option the provisions governing the effect(s) upon an Option of a Participants Termination of Employment.
(c) Rights of a Stockholder . A Participant shall have no rights as a stockholder with respect to shares of Common Stock covered by an Option (including voting rights) until the date the Participant becomes the holder of record of such shares of Common Stock. No adjustment shall be made for dividends or other rights for which the record date is prior to such date, except as provided in Section 10(b) or Section 10 of this Plan or as otherwise provided by the Committee.
8. | Options . |
(a) Grant, Term and Price . The grant, issuance, retention, vesting and/or settlement of any Option shall occur at such time and be subject to such terms and conditions as determined by the Committee or under criteria established by the Committee, which may include conditions based on continued employment or engagement, passage of time, attainment of age and/or service requirements and/or satisfaction of performance conditions. The term of an Option shall in no event be greater than ten years; provided, however, the term of an Option (other than an Incentive Stock Option) shall be automatically extended if, at the time of its scheduled expiration, the Participant holding such Option is prohibited by law or Odonates insider trading policy from exercising the Option, which extension shall expire on the 30th day following the date such prohibition no longer applies. The Committee will establish the price at which Common Stock may be purchased upon exercise of an Option, which, in no event will be less than the Fair Market Value of such shares on the date of grant; provided, however, that the exercise price per share of Common Stock with respect to an Option that is granted as a Substitute Option may be less than the Fair Market Value of the shares of Common Stock on the date such Option is granted if such exercise price is based on a formula set forth in the terms of the options held by such optionees or in the terms of the agreement providing for such merger or other acquisition that satisfies the requirements of: (i) Section 409A of the Code, if such options held by such optionees are not intended to qualify as incentive stock options within the meaning of Section 422 of the Code; and (ii) Section 424(a) of the Code, if such options held by such optionees are intended to qualify as incentive stock options within the meaning of Section 422 of the Code. The exercise price of any Option may be paid in cash or such other method as
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determined by the Committee, including an irrevocable commitment by a broker to pay over such amount from a sale of the shares of Common Stock issuable under an Option, the delivery of previously owned shares of Common Stock or withholding of shares of Common Stock deliverable upon exercise.
(b) Vesting . Options granted under this Plan, unless otherwise set forth in the applicable Grant Notice, shall vest as follows: (i) 25% of the aggregate number of Options subject to a Grant Notice will vest on the first anniversary of the date of grant; and (ii) the remaining 75% of the Options subject to the Grant Notice will vest in equal monthly installments over the following 36 months, such that the Options are fully vested as of the fourth anniversary of such date of grant. Upon a Termination of Employment, unless otherwise provided in the applicable Grant Notice, Options shall vest and/or be forfeited according to the following provisions:
(i) No Options shall continue to vest after the date of Termination of Employment.
(ii) If a Participant experiences a Termination of Employment due to an involuntary termination for Cause, all such options shall immediately forfeit, whether or not they are vested.
(c) No Repricing without Stockholder Approval . Other than in connection with a change in Odonates capitalization (as described in Section 10), the Committee shall not, without stockholder approval, reduce the exercise price of a previously awarded Option and, at any time when the exercise price of a previously awarded Option is above the Fair Market Value of a share of Common Stock, the Committee shall not, without stockholder approval, cancel and re-grant or exchange such Option for cash or a new Option with a lower (or no) exercise price.
(d) No Reload Grants . Options shall not be granted under the Plan in consideration for and shall not be conditioned upon the delivery of shares of Common Stock to Odonate in payment of the exercise price and/or tax withholding obligation under any other employee stock option.
(e) Incentive Stock Options . Notwithstanding anything to the contrary in this Section 8, in the case of the grant of an Incentive Stock Option, if the Participant owns stock possessing more than 10% of the combined voting power of all classes of stock of Odonate (a 10% Stockholder), the exercise price of such Option must be at least 110% of the Fair Market Value of the shares of Common Stock on the date of grant and the Option must expire within a period of not more than 5 years from the date of grant. Notwithstanding anything in this Section 8 to the contrary, options designated as Incentive Stock Options shall not be eligible for treatment under the Code as Incentive Stock Options (and will be deemed to be Nonqualified Stock Options) to the extent that either: (a) the aggregate Fair Market Value of shares of Common Stock (determined as of the time of grant) with respect to which such Options are exercisable for the first time by the Participant during any calendar year (under all plans of Odonate and any Subsidiary) exceeds $100,000, taking Options into account in the order in which they were granted; or (b) such Options otherwise remain exercisable but are not exercised within three (3) months (or such other period of time provided in Section 422 of the Code) of
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separation of service (as determined in accordance with Section 3401(c) of the Code and the regulations promulgated thereunder).
(f) No Stockholder Rights . Participants shall have no voting rights and will have no rights to receive dividends or Dividend Equivalents in respect of an Option or any shares of Common Stock subject to an Option until the Participant has become the holder of record of such shares.
9. | Conditions and Restrictions Upon Securities Subject to Options . |
The Committee may provide that the Common Stock issued upon exercise of an Option shall be subject to such further agreements, restrictions, conditions or limitations as the Committee in its discretion may specify prior to the exercise of such Option, including without limitation, conditions on vesting or transferability, forfeiture or repurchase provisions and method of payment for the Common Stock issued upon exercise, vesting or settlement of such Option (including the actual or constructive surrender of Common Stock already owned by the Participant) or payment of taxes arising in connection with an Option. Without limiting the foregoing, such restrictions may address the timing and manner of any resales by the Participant or other subsequent transfers by the Participant of any shares of Common Stock issued under an Option, including without limitation: (i) restrictions under an insider trading policy or pursuant to applicable law; (ii) restrictions designed to delay and/or coordinate the timing and manner of sales by the Participant and holders of other Company equity compensation arrangements; (iii) restrictions as to the use of a specified brokerage firm for such resales or other transfers; and (iv) provisions requiring Common Stock be sold on the open market or to Odonate in order to satisfy tax withholding or other obligations.
10. | Adjustment of and Changes in the Stock . |
(a) The number and kind of shares of Common Stock available for issuance under this Plan (including under any Options then outstanding), and the number and kind of shares of Common Stock subject to the limits set forth in Section 5 of this Plan, shall be equitably adjusted by the Committee to reflect any reorganization, reclassification, combination of shares, stock split, reverse stock split, spin-off, dividend or distribution of securities, property or cash (other than regular, quarterly cash dividends) or any other event or transaction that affects the number or kind of shares of Common Stock outstanding. Such adjustment may be designed to comply with Section 424 of the Code or may be designed to treat the shares of Common Stock available under the Plan and subject to Options as if they were all outstanding on the record date for such event or transaction or to increase the number of such shares of Common Stock to reflect a deemed reinvestment in shares of Common Stock of the amount distributed to Odonates security holders. The terms of any outstanding Option shall also be equitably adjusted by the Committee as to price, number or kind of shares of Common Stock subject to such Option, vesting and other terms to reflect the foregoing events, which adjustments need not be uniform as between different Options or different types of Options. No fractional shares of Common Stock shall be issued or issuable pursuant to such an adjustment.
(b) In the event there shall be any other change in the number or kind of outstanding shares of Common Stock, or any stock or other securities into which such Common
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Stock shall have been changed, or for which it shall have been exchanged, by reason of a Change in Control, other merger, consolidation or otherwise, then the Committee shall determine the appropriate and equitable adjustment to be effected, which adjustments need not be uniform between different Options. In addition, in the event of such change described in this paragraph, the Committee may accelerate the time or times at which any Option may be exercised, consistent with and as otherwise permitted under Section 409A of the Code, and may provide for cancellation of such accelerated Options that are not exercised within a time prescribed by the Committee in its sole discretion.
(c) Unless otherwise expressly provided in the Grant Notice or another contract, including an employment or services agreement, or under the terms of a transaction constituting a Change in Control, the Committee may provide that, following a Participants Termination of Employment without Cause within 24 months following a Change in Control, such Participant shall have the ability to exercise any portion of the Option not previously exercisable. Notwithstanding anything herein to the contrary, in the event of a Change in Control in which the acquiring or surviving company in the transaction does not assume or continue outstanding Options upon the Change in Control, immediately prior to the Change in Control, all Options that are not assumed or continued shall be treated as follows effective immediately prior to the Change in Control, the Participant shall have the ability to exercise such Option, including any portion of the Option not previously exercisable. In no event shall any action be taken pursuant to this Section 10(c) that would change the payment or settlement date of an Option in a manner that would result in the imposition of any additional taxes or penalties pursuant to Section 409A of the Code.
(d) Notwithstanding anything in this Section 10 to the contrary, in the event of a Change in Control, the Committee may provide for the: (i) the acceleration of vesting of all outstanding Options; or (ii) cancellation and cash settlement of all outstanding Options.
(e) Odonate shall notify Participants holding Options subject to any adjustments pursuant to this Section 10 of such adjustment, but (whether or not notice is given) such adjustment shall be effective and binding for all purposes of the Plan.
(f) Notwithstanding anything in this Section 10 to the contrary, an adjustment to an Option under this Section 10 shall be made in a manner that will not result in the grant of a new Option under Section 409A of the Code.
11. | Transferability . |
Each Option may not be sold, transferred for value, pledged, assigned or otherwise alienated or hypothecated by a Participant other than by will or the laws of descent and distribution, and shall be exercisable only by the Participant during his or her lifetime. Notwithstanding the foregoing: (i) outstanding Options may be exercised following the Participants death by the Participants beneficiaries or as permitted by the Committee; and (ii) a Participant may transfer or assign an Option as a gift to an entity wholly owned by such Participant (an Assignee Entity ), provided that such Assignee Entity shall be entitled to exercise assigned Options only during lifetime of the assigning Participant (or following the assigning Participants death, by the Participants beneficiaries or as otherwise permitted by the
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Committee) and provided further that such Assignee Entity shall not further sell, pledge, transfer, assign or otherwise alienate or hypothecate such Option.
12. | Compliance with Laws and Regulations . |
This Plan, the grant, issuance, vesting, exercise and settlement of Options hereunder and the obligation of Odonate to sell, issue or deliver shares of Common Stock under such Options, shall be subject to all applicable foreign, federal, state and local laws, rules and regulations, stock exchange rules and regulations, and to such approvals by any governmental or regulatory agency as may be required. Odonate shall not be required to register in a Participants name or deliver Common Stock prior to the completion of any registration or qualification of such shares under any foreign, federal, state or local law or any ruling or regulation of any government body which the Committee shall determine to be necessary or advisable. To the extent Odonate is unable to or the Committee deems it infeasible to obtain authority from any regulatory body having jurisdiction, which authority is deemed by Odonates counsel to be necessary to the lawful issuance and sale of any shares of Common Stock hereunder, Odonate and its Subsidiaries shall be relieved of any liability with respect to the failure to issue or sell such shares of Common Stock as to which such requisite authority shall not have been obtained. No Option shall be exercisable and no Common Stock shall be issued and/or transferable under any other Option unless a registration statement with respect to the Common Stock underlying such Option is effective and current or Odonate has determined, in its sole and absolute discretion, that such registration is unnecessary.
In the event an Option is granted to or held by a Participant who is employed or providing services outside the United States, the Committee may, in its sole discretion, modify the provisions of the Plan or of such Option as they pertain to such individual to comply with applicable foreign law or to recognize differences in local law, currency or tax policy. The Committee may also impose conditions on the grant, issuance, exercise, vesting, settlement or retention of Options in order to comply with such foreign law and/or to minimize Odonates obligations with respect to tax equalization for Participants employed outside their home country.
13. | Withholding . |
To the extent required by applicable federal, state, local or foreign law, the Committee may and/or a Participant shall make arrangements satisfactory to Odonate for the satisfaction of any withholding tax obligations that arise with respect to any Option, or the issuance or sale of any shares of Common Stock. Odonate shall not be required to recognize any Participant rights under an Option, to issue shares of Common Stock or to recognize the disposition of such shares of Common Stock until such obligations are satisfied. To the extent permitted or required by the Committee, these obligations may or shall be satisfied by Odonate withholding cash from any compensation otherwise payable to or for the benefit of a Participant, Odonate withholding a portion of the shares of Common Stock that otherwise would be issued to a Participant under such Option or by the Participant tendering to Odonate cash or, if allowed by the Committee, shares of Common Stock.
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14. | Amendment of the Plan or Options . |
The Board may amend, alter or discontinue this Plan and the Committee may amend or alter any agreement or other document evidencing an Option made under this Plan but, except as provided pursuant to the provisions of Section 10, no such amendment shall, without the approval of the stockholders of Odonate:
(a) increase the maximum number of shares of Common Stock for which Options may be granted under this Plan;
(b) reduce the price at which Options may be granted below the price provided for in Section 8(a);
(c) reprice outstanding Options as described in Section 8(c);
(d) extend the term of this Plan;
(e) change the class of persons eligible to be Participants;
(f) increase the individual maximum limits in Section 5(d) or 5(e); or
(g) otherwise amend the Plan in any manner requiring stockholder approval by law or the rules of any stock exchange or market or quotation system on which the Common Stock is traded, listed or quoted.
No amendment or alteration to the Plan or an Option or Grant Notice shall be made which would materially impair the rights of the holder of an Option, without such holders consent, provided that no such consent shall be required if the Committee determines in its sole discretion and prior to the date of any Change in Control that such amendment or alteration either: (i) is required or advisable in order for Odonate, the Plan or the Option to satisfy any law or regulation or to meet the requirements of or avoid adverse financial accounting consequences under any accounting standard; or (ii) is not reasonably likely to significantly diminish the benefits provided under such Option, or that any such diminishment has been adequately compensated.
15. | No Liability of Company . |
Odonate, any Subsidiary or Affiliate which is in existence or hereafter comes into existence, the Board and the Committee shall not be liable to a Participant or any other person as to: (a) the non-issuance or sale of shares of Common Stock as to which Odonate has been unable to obtain from any regulatory body having jurisdiction the authority deemed by Odonates counsel to be necessary to the lawful issuance and sale of any shares of Common Stock hereunder; and (b) any tax consequence expected, but not realized, by any Participant or other person due to the receipt, vesting, exercise or settlement of any Option granted hereunder.
16. | Non-Exclusivity of Plan . |
Neither the adoption of this Plan by the Board nor the submission of this Plan to the stockholders of Odonate for approval shall be construed as creating any limitations on the power
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of the Board or the Committee to adopt such other incentive arrangements as either may deem desirable, including without limitation, the granting of stock options otherwise than under this Plan or an arrangement not intended to qualify under Section 162(m) of the Code, and such arrangements may be either generally applicable or applicable only in specific cases.
17. | Governing Law . |
This Plan and any agreements or other documents hereunder shall be interpreted and construed in accordance with the laws of the State of Delaware and applicable federal law. Any reference in this Plan or in the agreement or other document evidencing any Options to a provision of law or to a rule or regulation shall be deemed to include any successor law, rule or regulation of similar effect or applicability.
18. | No Right to Employment, Reelection or Continued Service . |
Nothing in this Plan or a Grant Notice shall interfere with or limit in any way the right of Odonate, its Subsidiaries and/or its Affiliates to terminate any Participants employment, service on the Board or service at any time or for any reason not prohibited by law, nor shall this Plan or an Option itself confer upon any Participant any right to continue his or her employment or service for any specified period of time. Neither an Option nor any benefits arising under this Plan shall constitute an employment contract with Odonate, any Subsidiary and/or its Affiliates. Subject to Sections 4 and 14, this Plan and the benefits hereunder may be terminated at any time in the sole and exclusive discretion of the Board without giving rise to any liability on the part of Odonate, its Subsidiaries and/or its Affiliates.
19. | No Liability of Committee Members . |
No member of the Committee shall be personally liable by reason of any contract or other instrument executed by such member or on his or her behalf in his or her capacity as a member of the Committee nor for any mistake of judgment made in good faith, and Odonate shall indemnify and hold harmless each member of the Committee and each other employee, officer or director of Odonate to whom any duty or power relating to the administration or interpretation of the Plan may be allocated or delegated, against any cost or expense (including counsel fees) or liability (including any sum paid in settlement of a claim) arising out of any act or omission to act in connection with the Plan unless arising out of such persons own fraud or willful bad faith; provided, however, that approval of the Board shall be required for the payment of any amount in settlement of a claim against any such person. The foregoing right of indemnification shall not be exclusive of any other rights of indemnification to which such persons may be entitled under Odonates Certificate of Incorporation and Bylaws (as each may be amended from time to time), as a matter of law, or otherwise, or any power that Odonate may have to indemnify them or hold them harmless.
20. | Severability . |
If any provision of the Plan or any Option is or becomes or is deemed to be invalid, illegal, or unenforceable in any jurisdiction or as to any Person or Option, or would disqualify the Plan or any Option under any law deemed applicable by the Committee, such provision shall be construed or deemed amended to conform to the applicable laws, or if it cannot be construed
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or deemed amended without, in the determination of the Committee, materially altering the intent of the Plan or the Option, such provision shall be stricken as to such jurisdiction, Person or Option and the remainder of the Plan and any such Option shall remain in full force and effect.
21. | Unfunded Plan . |
The Plan is intended to be an unfunded plan. Participants are and shall at all times be general creditors of Odonate with respect to their Options. If the Committee or Odonate chooses to set aside funds in a trust or otherwise for the payment of Options under the Plan, such funds shall at all times be subject to the claims of the creditors of Odonate in the event of its bankruptcy or insolvency.
22. | Clawback/Recoupment . |
Options granted under this Plan will be subject to recoupment in accordance with any clawback policy that Odonate adopts or is required to adopt pursuant to the listing standards of any national securities exchange or association on which Odonates securities are listed or as is otherwise required by the Dodd-Frank Wall Street Reform and Consumer Protection Act or other applicable law. In addition, the Board may impose such other clawback, recovery or recoupment provisions in a Grant Notice as the Board determines necessary or appropriate, including but not limited to a reacquisition right in respect of previously acquired shares of Common Stock or other cash or property upon the occurrence of misconduct. No recovery of compensation under such a clawback policy will be an event giving rise to a right to resign for good reason or be deemed a constructive termination (or any similar term) as such terms are used in any agreement between any Participant and Odonate.
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Exhibit 10.3
ODONATE THERAPEUTICS, INC.
GRANT NOTICE FOR 2017 STOCK OPTION PLAN
[INCENTIVE][NONQUALIFIED] STOCK OPTIONS
FOR GOOD AND VALUABLE CONSIDERATION, Odonate Therapeutics, Inc. ( Odonate or the Company ), hereby grants to Participant named below the [incentive][nonqualified] stock option (the Option ) to purchase any part or all of the number of shares of its common stock, par value $0.01 per share (the Common Stock ), that are covered by this Option, as specified below, at the Exercise Price per share specified below and upon the terms and subject to the conditions set forth in this Grant Notice, the Odonate Therapeutics, Inc. 2017 Stock Option Plan (the Plan ) and the Standard Terms and Conditions (the Standard Terms and Conditions ) promulgated under such Plan, each as amended from time to time. This Option is granted pursuant to the Plan and is subject to and qualified in its entirety by the Standard Terms and Conditions.
Name of Participant: |
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Grant Date: |
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Number of Shares of Common Stock Covered by Option: |
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Exercise Price Per Share: |
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Expiration Date: |
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Vesting Schedule: |
This Option [is][is not] intended to qualify as an incentive stock option under Section 422 of the Internal Revenue Code of 1986, as amended. By accepting this Grant Notice, Participant acknowledges that he or she has received and read, and agrees that this Option shall be subject to, the terms of this Grant Notice, the Plan and the Standard Terms and Conditions.
ODONATE THERAPEUTICS, INC. |
Participant Signature | ||||
By: | ||||
Title: | Address (please print): | |||
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ODONATE THERAPEUTICS, INC.
STANDARD TERMS AND CONDITIONS FOR
[INCENTIVE][NONQUALIFIED] STOCK OPTIONS
These Standard Terms and Conditions apply to the Options granted pursuant to the Odonate Therapeutics, Inc. 2017 Stock Option Plan (the Plan ), which are identified as [incentive][nonqualified] stock options and are evidenced by a Grant Notice or an action of the Committee that specifically refers to these Standard Terms and Conditions. In addition to these Terms and Conditions, the Option shall be subject to the terms of the Plan, which are incorporated into these Standard Terms and Conditions by this reference. Capitalized terms not otherwise defined herein shall have the meaning set forth in the Plan.
1. | Terms of Option . |
Odonate Therapeutics, Inc. ( Odonate or the Company ) has granted to the Participant named in the Grant Notice provided to said Participant herewith (the Grant Notice ) [an incentive][a nonqualified] stock option (the Option ) to purchase up to the number of shares of the Companys common stock, par value $0.01 per share (the Common Stock ), set forth in the Grant Notice. The exercise price per share and the other terms and subject to the conditions of the Option are set forth in the Grant Notice, these Standard Terms and Conditions (as amended from time to time), and the Plan. For purposes of these Standard Terms and Conditions and the Grant Notice, any reference to the Company shall include a reference to any Subsidiary.
2. | [Incentive][Nonqualified] Stock Option . |
The Option [is][is not] intended to be an incentive stock option under Section 422 of the Internal Revenue Code of 1986, as amended (the Code ) and will be interpreted accordingly. [Section 422 of the Code provides, among other things, that the Participant shall not be taxed upon the exercise of a stock option that qualifies as an incentive stock option provided the Participant does not dispose of the shares of Common Stock acquired upon exercise of such option until the later of two years after such option is granted to the Participant and one year after such option is exercised. Notwithstanding anything to the contrary herein, Section 422 of the Code provides that incentive stock options (including, possibly, the Option) shall not be treated as incentive stock options if and to the extent that the aggregate fair market value of shares of Common Stock (determined as of the time of grant) with respect to which such incentive stock options are exercisable for the first time by the Participant during any calendar year (under all plans of the Company and its subsidiaries) exceeds $100,000, taking options into account in the order in which they were granted. Thus, if and to the extent that any shares of Common Stock issued under a portion of the Option exceeds the foregoing $100,000 limitation, such shares shall not be treated as issued under an incentive stock option pursuant to Section 422 of the Code.]
3. | Exercise of Option . |
The Option shall not be exercisable as of the Grant Date set forth in the Grant Notice. After the Grant Date, to the extent not previously exercised, and subject to termination or acceleration as provided in these Standard Terms and Conditions and the Plan, the Option shall be exercisable only to the extent it becomes vested, as described in the Grant Notice or the terms of the Plan, to purchase up to that number of shares of Common Stock as set forth in the Grant Notice, provided that (except as set forth in Section 4(a) below) the Participant remains employed with the Company and does not experience a Termination of Employment. The vesting period and/or exercisability of an Option may be adjusted by the Committee to reflect the decreased level of employment during any period in which the Participant is on an approved leave of absence or is employed on a less than full-time basis.
To exercise the Option (or any part thereof), the Participant shall deliver to the Company a Notice of Exercise in a form specified by the Committee, specifying the number of whole shares of Common Stock the Participant wishes to purchase and how the Participants shares of Common Stock should be registered (in the Participants name only or in the Participants and the Participants spouses names as community property or as joint tenants with right of survivorship).
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The exercise price (the Exercise Price ) of the Option is set forth in the Grant Notice. Odonate shall not be obligated to issue any shares of Common Stock until the Participant shall have paid the total Exercise Price for that number of shares of Common Stock. The Exercise Price may be paid in Common Stock, cash or a combination thereof, including an irrevocable commitment by a broker to pay over such amount from a sale of the Common Stock issuable under the Option, the delivery of previously owned Common Stock, withholding of shares of Common Stock deliverable upon exercise of the Option (but only to the extent share withholding is made available to the Participant by the Company), or in such other manners as may be permitted by the Committee.
Fractional shares may not be exercised. Shares of Common Stock will be issued as soon as practical after exercise. Notwithstanding the above, the Company shall not be obligated to deliver any shares of Common Stock during any period when the Company determines that the exercisability of the Option or the delivery of shares of Common Stock hereunder would violate any federal, state or other applicable laws.
4. | Expiration of Option . |
The Option shall expire and cease to be exercisable as of the earlier of: (i) the Expiration Date set forth in the Grant Notice; or (ii) the date specified below in connection with the Participants Termination of Employment:
(a) If the Participants Termination of Employment is by reason of death or Disability, or by the Company without Cause within 24 months following the occurrence of a Change in Control, the Participant (or the Participants estate, beneficiary or legal representative) may exercise the entire Option (regardless of whether then vested or exercisable) until the date that is 12 months following the date of such Termination of Employment.
(b) If the Participants Termination of Employment is for any reason other than death, Disability, by the Company without Cause within 24 months following the occurrence of a Change in Control or by the Company for Cause, the Participant may exercise any portion of the Option that is vested and exercisable at the time of such Termination of Employment until the date that is one month following the date of such Termination of Employment. Any portion of the Option that is not vested and exercisable at the time of such Termination of Employment (after taking into account any accelerated vesting under Section 10 of the Plan or any other agreement between the Participant and the Company) shall be forfeited and canceled as of the date of such Termination of Employment.
(c) If the Participants Termination of Employment is by the Company for Cause, the entire Option, whether or not then vested and exercisable, shall be immediately forfeited and canceled as of the date of such Termination of Employment.
5. | Restrictions on Resales of Shares Acquired Pursuant to Option Exercise . |
The Company may impose such restrictions, conditions or limitations as it determines appropriate as to the timing and manner of any resales by the Participant or other subsequent transfers by the Participant of any shares of Common Stock issued as a result of the exercise of the Option, including without limitation (a) restrictions under an insider trading policy,
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(b) restrictions designed to delay and/or coordinate the timing and manner of sales by Participant and other optionholders and (c) restrictions as to the use of a specified brokerage firm for such resales or other transfers.
6. | Income Taxes . |
The Company shall not deliver shares of Common Stock in respect of the exercise of any Option unless and until the Participant has made arrangements satisfactory to the Company to satisfy applicable withholding tax obligations. Unless the Participant pays the withholding tax obligations to the Company by cash or check in connection with the exercise of the Option (including an irrevocable commitment by a broker to pay over such amount from a sale of the Common Stock issuable under the Option), withholding may be effected, at the Companys option, withholding Common Stock issuable in connection with the exercise of the Option (provided that shares of Common Stock may be withheld only to the extent that such withholding will not result in adverse accounting treatment for the Company). The Participant acknowledges that the Company shall have the right to deduct any taxes required to be withheld by law in connection with the exercise of the Option from any amounts payable by it to the Participant (including, without limitation, future cash wages).
7. | Non-transferability of Option . |
Except as permitted by the Committee or as permitted under the Plan, the Participant may not assign or transfer the Option to anyone other than by will or the laws of descent and distribution and the Option shall be exercisable only by the Participant during his or her lifetime. The Company may cancel the Participants Option if the Participant attempts to assign or transfer it in a manner inconsistent with this Section 7.
8. | Other Agreements Superseded . |
The Grant Notice, these Standard Terms and Conditions and the Plan constitute the entire understanding between the Participant and Odonate regarding the Option. Any prior agreements, commitments or negotiations concerning the Option are superseded.
9. | Limitation of Interest in Shares Subject to Option . |
Neither the Participant (individually or as a member of a group) nor any beneficiary or other person claiming under or through the Participant shall have any right, title, interest, or privilege in or to any shares of Common Stock allocated or reserved for the purpose of the Plan or subject to the Grant Notice or these Standard Terms and Conditions except as to such shares of Common Stock, if any, as shall have been issued to such person upon exercise of the Option or any part of it. Nothing in the Plan, in the Grant Notice, these Standard Terms and Conditions or any other instrument executed pursuant to the Plan shall confer upon the Participant any right to continue in the Companys employ or service nor limit in any way the Companys right to terminate the Participants employment at any time for any reason.
10. | No Liability of Company . |
The Company and any Affiliate which is in existence or hereafter comes into existence shall not be liable to the Participant or any other person as to: (a) the non-issuance or sale of shares of Common Stock as to which the Company has been unable to obtain from any
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regulatory body having jurisdiction the authority deemed by the Companys counsel to be necessary to the lawful issuance and sale of any shares hereunder; and (b) any tax consequence expected, but not realized, by the Participant or other person due to the receipt, exercise or settlement of any Option granted hereunder.
11. | General . |
(a) In the event that any provision of these Standard Terms and Conditions is declared to be illegal, invalid or otherwise unenforceable by a court of competent jurisdiction, such provision shall be reformed, if possible, to the extent necessary to render it legal, valid and enforceable, or otherwise deleted, and the remainder of these Standard Terms and Conditions shall not be affected except to the extent necessary to reform or delete such illegal, invalid or unenforceable provision.
(b) The headings preceding the text of the sections hereof are inserted solely for convenience of reference, and shall not constitute a part of these Standard Terms and Conditions, nor shall they affect its meaning, construction or effect.
(c) These Standard Terms and Conditions shall inure to the benefit of and be binding upon the parties hereto and their respective permitted heirs, beneficiaries, successors and assigns.
(d) These Standard Terms and Conditions shall be construed in accordance with and governed by the laws of the State of Delaware, without regard to principles of conflicts of law.
(e) In the event of any conflict between the Grant Notice, these Standard Terms and Conditions and the Plan, the Grant Notice and these Standard Terms and Conditions shall control. In the event of any conflict between the Grant Notice and these Standard Terms and Conditions, the Grant Notice shall control.
(f) All questions arising under the Plan or under these Standard Terms and Conditions shall be decided by the Committee in its total and absolute discretion.
(g) Notwithstanding anything herein or in the Plan to the contrary, no adjustments to the Option and/or any of the terms hereof shall be made pursuant to Section 10 of the Plan or otherwise in connection with the transactions to be consummated subsequent to Grant Date but prior to the consummation of the Companys initial public offering.
12. | Electronic Delivery . |
By executing the Grant Notice, the Participant hereby consents to the delivery of information (including, without limitation, information required to be delivered to the Participant pursuant to applicable securities laws) regarding Odonate and the Subsidiaries, the Plan, the Option and the Common Stock via Company web site or other electronic delivery.
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Exhibit 10.4
ODONATE THERAPEUTICS, INC.
2017 EMPLOYEE STOCK PURCHASE PLAN
1. | Purpose . |
The purpose of the 2017 Employee Stock Purchase Plan, including any sub-plans or appendices hereto (the Plan ), is to provide an opportunity for Employees of Odonate Therapeutics, Inc., a Delaware corporation ( Odonate ) and its Participating Subsidiaries to purchase Common Stock of Odonate and thereby to have an additional incentive to contribute to the prosperity of Odonate. It is the intention of Odonate that the Plan (excluding any sub-plans thereof except as expressly provided in the terms of such sub-plan) qualify as an Employee Stock Purchase Plan under Section 423 of the U.S. Internal Revenue Code of 1986, as amended (the Code ), and the Plan shall be administered in accordance with this intent. In addition, the Plan authorizes the grant of options pursuant to sub-plans or special rules adopted by the Committee designed to achieve desired tax or other objectives in particular locations outside of the United States or to achieve other business objectives in the determination of the Committee, which sub-plans shall not be required to comply with the requirements of Section 423 of the Code or all of the specific provisions of the Plan, including but not limited to terms relating to eligibility, Offering Periods or Purchase Price.
2. | Definitions . |
(a) Applicable Law means the legal requirements relating to the administration of an employee stock purchase plan under applicable U.S. state corporate laws, U.S. federal and applicable state securities laws, the Code, any stock exchange rules or regulations and the applicable laws of any other country or jurisdiction, as such laws, rules, regulations and requirements shall be in place from time to time.
(b) Board means the Board of Directors of Odonate.
(c) Code means the Internal Revenue Code of 1986, as amended from time to time, and the rulings and regulations issued thereunder.
(d) Commencement Date means, with respect to a given Offering Period, the first Trading Day during such Offering Period.
(e) Committee means the Compensation Committee of the Board (or any successor committee) or the officer, officers or committee as designated by the Board to administer the Plan in accordance with Section 15.
(f) Common Stock means the common stock of Odonate, par value $0.01 per share, or any securities into which such Common Stock may be converted.
(g) Compensation means the total compensation paid by Odonate to an Employee with respect to an Offering Period, including salary, commissions, overtime, shift differentials, performance-based cash bonuses and all or any portion of any item of
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compensation considered by Odonate to be part of the Employees regular earnings, but excluding items not considered by Odonate to be part of the Employees regular earnings. Items excluded from the definition of Compensation include but are not limited to such items as relocation bonuses, expense reimbursements, certain bonuses paid in connection with mergers and acquisitions, author incentives, recruitment and referral bonuses, foreign service premiums, differentials and allowances, imputed income pursuant to Section 79 of the Code, income realized as a result of participation in any stock option, restricted stock, restricted stock unit, stock purchase or similar equity plan maintained by Odonate or a Participating Subsidiary and tuition and other reimbursements. The Committee shall have the authority to determine and approve all forms of pay to be included in the definition of Compensation and may change the definition on a prospective basis.
(h) Effective Date means the date of the underwriting agreement between Odonate and the underwriter(s) managing the initial public offering of the Common Stock, pursuant to which the Common Stock is priced for the initial public offering of Odonates securities pursuant to a registration statement filed and declared effective pursuant to the Securities Act.
(i) Employee means an individual classified as an employee (within the meaning of Code Section 3401(c) and the regulations thereunder) by Odonate or a Participating Subsidiary on Odonates or such Participating Subsidiarys payroll records during the relevant participation period. Notwithstanding the foregoing, no employee of Odonate or a Participating Subsidiary shall be included within the definition of Employee if such persons customary employment is for less than 20 hours per week or for less 5 months per year. Individuals classified as independent contractors, consultants or advisers are not considered Employees.
(j) Enrollment Period means, with respect to a given Offering Period, that period established by the Committee prior to the commencement of such Offering Period during which Employees may elect to participate in order to purchase Common Stock at the end of that Offering Period in accordance with the terms of this Plan.
(k) Exchange Act means the Securities Exchange Act of 1934, as amended from time to time, and any reference to a section of the Exchange Act shall include any successor provision of the Exchange Act.
(l) Fair Market Value means as of any date, the value of the Common Stock determined as follows: (i) if the Common Stock is listed on any established stock exchange, system or market, its Fair Market Value shall be the closing price for the Common Stock as quoted on such exchange, system or market as reported in the Wall Street Journal or such other source as the Committee deems reliable (or, if no sale of Common Stock is reported for such date, on the next preceding date on which any sale shall have been reported); and (ii) in the absence of an established market for the Common Stock, the Fair Market Value thereof shall be determined in good faith by the Committee by the reasonable application of a reasonable valuation method, taking into account factors consistent with Treas. Reg. § 409A-1(b)(5)(iv)(B) as the Committee deems appropriate.
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(m) Offering Period means a period of no more than 27 months at the end of which an option granted pursuant to the Plan shall be exercised. The Plan shall be implemented by a series of Offering Periods with terms established by the Committee in accordance with the Plan. Once established, the duration and timing of Offering Periods may be changed or modified by the Committee as permitted by the Plan. If the Committee does not establish different rules with respect to an Offering Period, then the duration of an Offering Period shall be 6 months and there shall be no overlapping Offering Periods.
(n) Offering Price means the Fair Market Value of a share of Common Stock on the Commencement Date for a given Offering Period.
(o) Participant means a participant in the Plan as described in Section 5 of the Plan.
(p) Participating Subsidiary means a Subsidiary that has been designated by the Committee in its sole discretion as eligible to participate in the Plan with respect to its Employees.
(q) Purchase Date means the last Trading Day of each Offering Period.
(r) Purchase Price shall have the meaning set out in Section 8(b).
(s) Securities Act means the U.S. Securities Act of 1933, as amended, as amended from time to time, and any reference to a section of the Securities Act shall include any successor provision of the Securities Act.
(t) Stockholder means a record holder of shares entitled to vote such shares of Common Stock under Odonates bylaws.
(u) Subsidiary means any business entity (including a limited liability company, corporation or a partnership) in which Odonate owns (either directly or indirectly through one or more other Subsidiaries) 50% or more of the total combined voting power of all classes of outstanding equity interests.
(v) Trading Day means a day on which U.S. national stock exchanges are open for trading and the Common Stock is being publicly traded on one or more of such markets.
3. | Eligibility . |
(a) Any Employee of Odonate or any Participating Subsidiary at the beginning of an Enrollment Period for a given Offering Period shall be eligible to participate in the Plan with respect to such Offering Period and future Offering Periods, provided that the Committee may establish administrative rules requiring that employment commence some minimum period (not to exceed 90 days) prior to an Enrollment Period and/or that customary employment exceed a specified number of hours or period during a calendar year to be eligible to participate with respect to the associated Offering Period. The Committee may also determine that a designated group of highly compensated Employees is ineligible to participate in the Plan so long as the excluded category fits within the definition of highly compensated employee in
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Code Section 414(q). If the Committee does not establish different rules with respect to an Offering Period, the minimum period of employment that must be completed prior to the beginning of an Enrollment Period shall be 5 working days.
(b) No Employee may participate in the Plan if immediately after an option is granted the Employee owns or is considered to own (within the meaning of Code Section 424(d)) shares of Common Stock, including Common Stock which the Employee may purchase by conversion of convertible securities or under outstanding options granted by Odonate or its Subsidiaries, possessing 5% or more of the total combined voting power or value of all classes of stock of Odonate or of any of its Subsidiaries. All Employees who participate in the Plan shall have the same rights and privileges under the Plan, except for differences that may be mandated by local law and that are consistent with Code Section 423(b)(5); provided that individuals participating in a sub-plan adopted pursuant to Section 16 which is not designed to qualify under Code section 423 need not have the same rights and privileges as Employees participating in the Code section 423 Plan.
4. | Offering Periods . |
The Plan shall be implemented by a series of Offering Periods, which shall possess terms specified by the Committee in accordance with the terms of the Plan. Offering Periods shall continue until the Plan is terminated pursuant to Section 14 hereof. Once established, the Committee shall have the authority to change the frequency and/or duration of Offering Periods (including the Commencement Dates thereof) with respect to future Offering Periods if such change is announced prior to the scheduled occurrence of the Enrollment Period for the first Offering Period to be affected thereafter. If the Committee does not establish different rules with respect to an Offering Period, then the duration of an Offering Period shall be 6 months and there shall be no overlapping Offering Periods.
5. | Participation . |
(a) An Employee who is eligible to participate in the Plan in accordance with its terms at the beginning of an Enrollment Period for an Offering Period and elects to participate in such Offering Period shall automatically receive an option in accordance with Section 8(a). Such an Employee shall become a Participant by completing and submitting, on or before the date prescribed by the Committee with respect to a given Offering Period, a completed payroll deduction authorization and Plan enrollment form provided by Odonate or its Participating Subsidiaries or by following an electronic or other enrollment process as prescribed by the Committee. An eligible Employee may authorize payroll deductions at the rate of any whole percentage of the Employees Compensation, not to be less than 1% and not to exceed 10% of the Employees Compensation (or such other percentages as the Committee may establish from time to time before an Enrollment Period for a future Offering Period) of such Employees Compensation on each payday during the Offering Period. All payroll deductions will be held in a general corporate account or a trust account. No interest shall be paid or credited to the Participant with respect to such payroll deductions. Odonate shall maintain or cause to be maintained a separate bookkeeping account for each Participant under the Plan and the amount of each Participants payroll deductions shall be credited to such account. A Participant may not
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make any additional payments into such account, unless payroll deductions are prohibited under Applicable Law, in which case the provisions of Section 5(b) of the Plan shall apply.
(b) Notwithstanding any other provisions of the Plan to the contrary, in locations where local law prohibits payroll deductions, an eligible Employee may elect to participate through contributions to his or her account under the Plan in a form acceptable to the Committee. In such event, any such Employees shall be deemed to be participating in a sub-plan, unless the Committee otherwise expressly provides that such Employees shall be treated as participating in the Plan.
(c) Under procedures and at times established by the Committee, a Participant may withdraw from the Plan during an Offering Period, by completing and filing a new payroll deduction authorization and Plan enrollment form with Odonate or by following electronic or other procedures prescribed by the Committee. If a Participant withdraws from the Plan during an Offering Period, his or her accumulated payroll deductions will be refunded to the Participant without interest, his or her right to participate in the current Offering Period will be automatically terminated and no further payroll deductions for the purchase of Common Stock will be made during the Offering Period. Any Participant who wishes to withdraw from the Plan during an Offering Period, must complete the withdrawal procedures prescribed by the Committee, subject to any rules established by the Committee, or changes to such rules, pertaining to the timing of withdrawals, limiting the frequency with which Participants may withdraw and re-enroll in the Plan, or imposing a waiting period on Participants wishing to re-enroll following withdrawal.
(d) A Participant may not increase his or her rate of contribution through payroll deductions or otherwise during a given Offering Period. A Participant may decrease his or her rate of contribution through payroll deductions during a given Offering Period during such times specified by the Committee by filing a new payroll deduction authorization and Plan enrollment form or by following electronic or other procedures prescribed by the Committee. If a Participant has not followed such procedures to change the rate of contribution, the rate of contribution shall continue at the originally elected rate throughout the Offering Period and future Offering Periods. Notwithstanding the foregoing, to the extent necessary to comply with Section 423(b)(8) of the Code for a given calendar year, the Committee may reduce a Participants payroll deductions to 0% at any time during an Offering Period scheduled to end during such calendar year. Payroll deductions shall re-commence at the rate provided in such Participants enrollment form at the beginning of the first Offering Period, which is scheduled to end in the following calendar year, unless terminated by the Participant as provided in Section 5(c).
6. | Termination of Employment . |
In the event any Participant terminates employment with Odonate and its Participating Subsidiaries for any reason (including death) prior to the expiration of an Offering Period, the Participants participation in the Plan shall terminate and all amounts credited to the Participants account shall be paid to the Participant or, in the case of death, to the Participants heirs or estate, without interest. Whether a termination of employment has occurred shall be determined by the Committee. If a Participants termination of employment occurs within a certain period of time as specified by the Committee (not to exceed 30 days) prior to the Purchase Date of the Offering
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Period then in progress, his or her option for the purchase of shares of Common Stock will be exercised on such Purchase Date in accordance with Section 9 as if such Participant were still employed by Odonate. If the Committee does not establish different rules with respect to an Offering Period, then if a Participants termination of employment occurs on or after the 5 th working day preceding the Purchase Date of an Offering Period, then his or her option for the purchase of shares of Common Stock will be exercised on such Purchase Date in accordance with Section 9 as if such Participant were still employed by Odonate. Following the purchase of shares on such Purchase Date, the Participants participation in the Plan shall terminate and all amounts credited to the Participants account shall be paid to the Participant or, in the case of death, to the Participants heirs or estate, without interest. The Committee may also establish rules regarding when leaves of absence or changes of employment status will be considered to be a termination of employment, including rules regarding transfer of employment among Participating Subsidiaries, Subsidiaries and Odonate, and the Committee may establish termination-of-employment procedures for this Plan that are independent of similar rules established under other benefit plans of Odonate and its Subsidiaries; provided that such procedures are not in conflict with the requirements of Section 423 of the Code.
7. | Stock . |
Subject to adjustment as set forth in Section 11, the aggregate number of shares of Common Stock which may be issued pursuant to the Plan shall initially be 500,000 shares (the Share Reserve ). The Committee may change this limitation at any time on a prospective basis to apply to future Offering Periods. If, on a given Purchase Date, the number of shares with respect to which options are to be exercised exceeds either maximum, the Committee shall make, as applicable, such adjustment or pro rata allocation of the shares remaining available for purchase in as uniform a manner as shall be practicable and as it shall determine to be equitable.
8. | Offering . |
(a) On the Commencement Date relating to each Offering Period, each eligible Employee, whether or not such Employee has elected to participate as provided in Section 5(a), shall be granted an option to purchase a number of whole shares of Common Stock (as adjusted as set forth in Section 11) established by the Committee, which may be purchased with the payroll deductions accumulated on behalf of such Employee during each Offering Period at the purchase price specified in Section 8(b) below, subject to the additional limitation that no Employee participating in the Plan shall be granted an option to purchase Common Stock under the Plan if such option would permit his or her rights to purchase stock under all employee stock purchase plans (described in Section 423 of the Code) of Odonate and its Subsidiaries to accrue at a rate which exceeds U.S. $25,000 of the Fair Market Value of such Common Stock (determined at the time such option is granted) for each calendar year in which such option is outstanding at any time. For purposes of the Plan, an option is granted on a Participants Commencement Date. An option will expire upon the earliest to occur of (i) the termination of a Participants participation in the Plan or such Offering Period (ii) the termination of the Offering Period. This Section 8(a) shall be interpreted so as to comply with Code Section 423(b)(8).
(b) The Purchase Price under each option shall be with respect to an Offering Period the lower of (i) a percentage (not less than 85%) ( Designated Percentage ) of the
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Offering Price, or (ii) the Designated Percentage of the Fair Market Value of a share of Common Stock on the Purchase Date on which the Common Stock is purchased; provided that the Purchase Price may be adjusted by the Committee pursuant to Sections 11 or 12 in accordance with Section 424(a) of the Code. For a given Offering Period, the Designated Percentage shall be established no later than the beginning of the Enrollment Period for such Offering Period. The Committee may change the Designated Percentage with respect to any future Offering Period, but not to below 85%, and the Committee may determine with respect to any prospective Offering Period that the Purchase Price shall be the Designated Percentage of the Fair Market Value of a share of the Common Stock solely on the Purchase Date. If the Committee does not establish the Designated Percentage prior to the beginning of the Enrollment Period for a given Offering Period, the Designated Percentage for such Offering Period shall be 85%.
9. | Purchase of Stock . |
Unless a Participant withdraws from the Plan as provided in Section 5(c), terminates employment prior to the end of an Offering Period as provided in Section 6, or except as provided in Sections 7, 12 or 14(b), upon the expiration of each Offering Period, a Participants option shall be exercised automatically for the purchase of that number of whole shares of Common Stock which the accumulated payroll deductions credited to the Participants account at that time shall purchase at the applicable price specified in Section 8(b) in accordance with the terms of the Plan, including Section 7. Notwithstanding the foregoing, Odonate or its Participating Subsidiary may make such provisions and take such action as it deems necessary or appropriate for the withholding of taxes and/or social insurance and/or other amounts which Odonate or its Participating Subsidiary determines is required by Applicable Law. Each Participant, however, shall be responsible for payment of all individual tax liabilities arising under the Plan. The shares of Common Stock purchased upon exercise of an option hereunder shall be considered for tax purposes to be sold to the Participant on the Purchase Date. A Participants option to purchase shares of Common Stock hereunder is exercisable only by him or her.
10. | Payment and Delivery . |
As soon as practicable after the exercise of an option, Odonate shall deliver or cause to have delivered to the Participant a record of the Common Stock purchased and the balance of any amount of payroll deductions credited to the Participants account not used for the purchase of Common Stock, except as specified below. The Committee may permit or require that shares be deposited directly with a broker designated by the Committee or to a designated agent of Odonate, and the Committee may utilize electronic or automated methods of share transfer. The Committee may require that shares be retained with such broker or agent for a designated period of time and/or may establish other procedures to permit tracking of disqualifying dispositions of such shares. If the Committee does not establish different rules with respect to an Offering Period, all shares of Common Stock purchased on each Purchase Date may not be sold prior to the earliest of: (i) the first anniversary of the applicable Purchase Date; (ii) the date on which a Participant terminates service with Odonate or a Participating Subsidiary, or (iii) the consummation of a Change of Control (as defined in the 2017 Stock Option Plan). Odonate or its Participating Subsidiary shall retain the amount of payroll deductions used to purchase Common Stock as full payment for the Common Stock and the Common Stock shall then be fully paid and
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non-assessable. No Participant shall have any voting, dividend, or other Stockholder rights with respect to shares subject to any option granted under the Plan until the shares subject to the option have been purchased and delivered to the Participant as provided in this Section 10. The Committee may in its discretion direct Odonate to retain in a Participants account for the subsequent Offering Period any payroll deductions which are not sufficient to purchase a whole share of Common Stock or return such amount to the Participant. Any other amounts left over in a Participants account after a Purchase Date shall be returned to the Participant. If the Committee does not establish different rules with respect to an Offering Period, then all amounts left over in a Participants account after a Purchase Date shall be returned to the Participant.
11. | Recapitalization . |
Subject to any required action by the Stockholders of Odonate, if there is any change in the outstanding shares of Common Stock or other securities of Odonate because of a merger, consolidation, spin-off, reorganization, recapitalization, dividend in property other than cash, extraordinary dividend whether in cash and/or other property, stock split, reverse stock split, stock dividend, liquidating dividend, combination or reclassification of the Common Stock or other securities (including any such change in the number of shares of Common Stock or other securities effected in connection with a change in domicile of Odonate), or any other increase or decrease in the number of shares of Common Stock or other securities effected without receipt of consideration by Odonate, provided that conversion of any convertible securities of Odonate shall not be deemed to have been effected without receipt of consideration , the type and number of securities covered by each option under the Plan which has not yet been exercised and the type and number of securities which have been authorized and remain available for issuance under the Plan, as well as the maximum number of securities which may be purchased by a Participant in an Offering Period, and the price per share covered by each option under the Plan which has not yet been exercised, shall be appropriately and proportionally adjusted by the Board, and the Board shall take any further actions which, in the exercise of its discretion, may be necessary or appropriate under the circumstances. The Boards determinations under this Section 11 shall be conclusive and binding on all parties.
12. | Merger, Liquidation and Other Corporate Transactions . |
(a) In the event of a proposed liquidation or dissolution of Odonate, the Offering Period will terminate immediately prior to the consummation of such proposed transaction, unless otherwise provided by the Board in its sole discretion, and all outstanding options shall automatically terminate and the amounts of all payroll deductions will be refunded without interest to the Participants.
(b) In the event of a proposed sale of all or substantially all of the assets of Odonate, or the merger or consolidation or similar combination of Odonate with or into another entity, then in the sole discretion of the Board, (1) each option shall be assumed or an equivalent option shall be substituted by the successor corporation or parent or subsidiary of such successor entity, (2) on a date established by the Board on or before the date of consummation of such merger, consolidation, combination or sale, such date shall be treated as a Purchase Date, and all outstanding options shall be exercised on such date, (3) all outstanding options shall terminate
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and the accumulated payroll deductions will be refunded without interest to the Participants, or (4) outstanding options shall continue unchanged.
13. | Transferability . |
Neither payroll deductions credited to a Participants bookkeeping account nor any rights to exercise an option or to receive shares of Common Stock under the Plan may be voluntarily or involuntarily assigned, transferred, pledged, or otherwise disposed of in any way, and any attempted assignment, transfer, pledge, or other disposition shall be null and void and without effect. If a Participant in any manner attempts to transfer, assign or otherwise encumber his or her rights or interests under the Plan, other than as permitted by the Code, such act shall be treated as an election by the Participant to discontinue participation in the Plan pursuant to Section 5(c).
14. | Amendment or Termination of the Plan . |
(a) The Plan shall continue from the Effective Date until the time that the Plan is terminated in accordance with Section 14(b).
(b) The Board or the Committee may, in its sole discretion, insofar as permitted by law, terminate or suspend the Plan, or revise or amend it in any respect whatsoever, except that, without approval of the Stockholders, no such revision or amendment shall increase the number of shares subject to the Plan, other than an adjustment under Section 11 of the Plan, or make other changes for which Stockholder approval is required under Applicable Law. Upon a termination or suspension of the Plan, the Board may in its discretion (i) return without interest the payroll deductions credited to Participants accounts to such Participants or (ii) set an earlier Purchase Date with respect to an Offering Period then in progress.
15. | Administration . |
(a) The Board has appointed the Compensation Committee of the Board to administer the Plan (the Committee ), who will serve for such period of time as the Board may specify and whom the Board may remove at any time. The Committee will have the authority and responsibility for the day-to-day administration of the Plan, the authority and responsibility specifically provided in this Plan and any additional duty, responsibility and authority delegated to the Committee by the Board, which may include any of the functions assigned to the Board in this Plan. The Committee may delegate to a sub-committee and/or to an officer or officers or employees of Odonate the day-to-day administration of the Plan. The Committee shall have full power and authority to adopt, amend and rescind any rules and regulations which it deems desirable and appropriate for the proper administration of the Plan, to construe and interpret the provisions and supervise the administration of the Plan, to make factual determinations relevant to Plan entitlements and to take all action in connection with administration of the Plan as it deems necessary or advisable, consistent with the delegation from the Board. Decisions of the Committee shall be final and binding upon all Participants. Any decision reduced to writing and signed by a majority of the members of the Committee shall be fully effective as if it had been made at a meeting of the Committee duly held.
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(b) In addition to such other rights of indemnification as they may have as members of the Board or officers or employees of Odonate, members of the Board and of the Committee and their delegates shall be indemnified by Odonate against all reasonable expenses, including attorneys fees, actually and necessarily incurred in connection with the defense of any action, suit or proceeding, or in connection with any appeal therein, to which they or any of them may be a party by reason of any action taken or failure to act under or in connection with the Plan, or any right granted under the Plan, and against all amounts paid by them in settlement thereof (provided such settlement is approved by independent legal counsel selected by Odonate) or paid by them in satisfaction of a judgment in any such action, suit or proceeding, except in relation to matters as to which it shall be adjudged in such action, suit or proceeding that such person is liable for gross negligence, bad faith or intentional misconduct in duties; provided, however, that within 60 days after the institution of such action, suit or proceeding, such person shall offer to Odonate, in writing, the opportunity at its own expense to handle and defend the same.
16. | Committee Rules for Foreign Jurisdictions . |
The Committee may adopt rules or procedures relating to the operation and administration of the Plan to accommodate the specific requirements of local laws and procedures. Without limiting the generality of the foregoing, the Committee is specifically authorized to adopt rules and procedures regarding handling of payroll deductions or other contributions by Participants, payment of interest, conversion of local currency, data privacy security, payroll tax, withholding procedures and handling of stock certificates which vary with local requirements; however, if such varying provisions are not in accordance with the provisions of Section 423(b) of the Code, including but not limited to the requirement of Section 423(b)(5) of the Code that all options granted under the Plan shall have the same rights and privileges unless otherwise provided under the Code and the regulations promulgated thereunder, then the individuals affected by such varying provisions shall be deemed to be participating under a sub-plan and not in the Plan. The Committee may also adopt sub-plans applicable to particular Subsidiaries or locations, which sub-plans may be designed to be outside the scope of Code section 423 and shall be deemed to be outside the scope of Code section 423 unless the terms of the sub-plan provide to the contrary. The rules of such sub-plans may take precedence over other provisions of this Plan, with the exception of Section 7, but unless otherwise superseded by the terms of such sub-plan, the provisions of this Plan shall govern the operation of such sub-plan. The Committee shall not be required to obtain the approval of the Stockholders prior to the adoption, amendment or termination of any sub-plan unless required by the laws of the foreign jurisdiction in which Employees participating in the sub-plan are located.
17. | Securities Laws Requirements . |
(a) No option granted under the Plan may be exercised to any extent unless the shares to be issued upon such exercise under the Plan are covered by an effective registration statement pursuant to the Securities Act and the Plan is in material compliance with all applicable provisions of law, domestic or foreign, including, without limitation, the Securities Act, the Exchange Act, the rules and regulations promulgated thereunder, applicable state and foreign securities laws and the requirements of any stock exchange upon which the Shares may then be listed, subject to the approval of counsel for Odonate with respect to such compliance. If
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on a Purchase Date in any Offering Period hereunder, the Plan is not so registered or in such compliance, options granted under the Plan which are not in material compliance shall not be exercised on such Purchase Date, and the Purchase Date shall be delayed until the Plan is subject to such an effective registration statement and such compliance, except that the Purchase Date shall not be delayed more than 12 months and the Purchase Date shall in no event be more than 27 months from the Commencement Date relating to such Offering Period. If, on the Purchase Date of any offering hereunder, as delayed to the maximum extent permissible, the Plan is not registered and in such compliance, options granted under the Plan which are not in material compliance shall not be exercised and all payroll deductions accumulated during the Offering Period (reduced to the extent, if any, that such deductions have been used to acquire shares of Common Stock) shall be returned to the Participants, without interest. The provisions of this Section 17 shall comply with the requirements of Section 423(b)(5) of the Code to the extent applicable.
(b) As a condition to the exercise of an option, Odonate may require the person exercising such option to represent and warrant at the time of any such exercise that the Shares are being purchased only for investment and without any present intention to sell or distribute such Shares if, in the opinion of counsel for Odonate, such a representation is required by any of the aforementioned applicable provisions of law.
18. | Government Regulations . |
This Plan and Odonates obligation to sell and deliver shares of its stock under the Plan shall be subject to the approval of any governmental authority required in connection with the Plan or the authorization, issuance, sale or delivery of stock hereunder.
19. | No Enlargement of Employee Rights . |
Nothing contained in this Plan shall be deemed to give any Employee or other individual the right to be retained in the employ or service of Odonate or any Participating Subsidiary or to interfere with the right of Odonate or Participating Subsidiary to discharge any Employee or other individual at any time, for any reason or no reason, with or without notice.
20. | Governing Law . |
This Plan shall be governed by applicable laws of the State of Delaware and applicable federal law.
21. | Effective Date . |
This Plan shall be effective on the Effective Date, subject to approval of the Stockholders of Odonate within 12 months before or after its date of adoption by the Board.
22. | Reports . |
Individual accounts shall be maintained for each Participant in the Plan. Statements of account shall be made available to Participants at least annually, which statements shall set forth
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the amounts of payroll deductions, the Purchase Price, the number of shares of Common Stock purchased and the remaining cash balance, if any.
23. | Designation of Beneficiary for Owned Shares . |
With respect to shares of Common Stock purchased by the Participant pursuant to the Plan and held in an account maintained by Odonate or its assignee on the Participants behalf, the Participant may be permitted to file a written designation of beneficiary, who is to receive any shares and cash, if any, from the Participants account under the Plan in the event of such Participants death subsequent to the end of an Offering Period but prior to delivery to him or her of such shares and cash. In addition, a Participant may file a written designation of a beneficiary who is to receive any cash from the Participants account under the Plan in the event of such Participants death prior to the Purchase Date of an Offering Period. If a Participant is married and the designated beneficiary is not the spouse, spousal consent shall be required for such designation to be effective, to the extent required by local law. The Participant (and if required under the preceding sentence, his or her spouse) may change such designation of beneficiary at any time by written notice. Subject to local legal requirements, in the event of a Participants death, Odonate or its assignee shall deliver any shares of Common Stock and/or cash to the designated beneficiary. Subject to local law, in the event of the death of a Participant and in the absence of a beneficiary validly designated who is living at the time of such Participants death, Odonate shall deliver such shares of Common Stock and/or cash to the executor or administrator of the estate of the Participant, or if no such executor or administrator has been appointed (to the knowledge of Odonate), Odonate in its sole discretion, may deliver (or cause its assignee to deliver) such shares of Common Stock and/or cash to the spouse, or to any one or more dependents or relatives of the Participant, or if no spouse, dependent or relative is known to Odonate, then to such other person as Odonate may determine. The provisions of this Section 23 shall in no event require Odonate to violate local law, and Odonate shall be entitled to take whatever action it reasonably concludes is desirable or appropriate in order to transfer the assets allocated to a deceased Participants account in compliance with local law.
24. | Additional Restrictions of Rule 16b-3 . |
The terms and conditions of options granted hereunder to, and the purchase of shares of Common Stock by, persons subject to Section 16 of the Exchange Act shall comply with the applicable provisions of Rule 16b-3. This Plan shall be deemed to contain, and such options shall contain, and the shares of Common Stock issued upon exercise thereof shall be subject to, such additional conditions and restrictions, if any, as may be required by Rule 16b-3 to qualify for the maximum exemption from Section 16 of the Exchange Act with respect to Plan transactions.
25. | Notices . |
All notices or other communications by a Participant to Odonate or the Committee under or in connection with the Plan shall be deemed to have been duly given when received in the form specified by Odonate or the Committee at the location, or by the person, designated by Odonate for the receipt thereof.
* * *
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Exhibit 10.6
INDEMNIFICATION AGREEMENT
This Indemnification Agreement (this Agreement ) is entered into as of November [ ], 2017 (the Effective Date ) by and between Odonate Therapeutics, Inc., a Delaware corporation (the Company ), and [ ] (the Indemnitee ).
RECITALS
WHEREAS, the Company has adopted provisions in its Bylaws providing for indemnification and advancement of expenses of its directors and officers to the fullest extent authorized by the General Corporation Law of the State of Delaware (the DGCL ), and the Company wishes to clarify and enhance the rights and obligations of the Company and the Indemnitee with respect to indemnification and advancement of expenses;
WHEREAS, in order to induce and encourage highly experienced and capable persons such as the Indemnitee to serve and continue to serve as directors and officers of the Company and in any other capacity with respect to the Company as the Company may request, and to otherwise promote the desirable end that such persons shall resist what they consider unjustified lawsuits and claims made against them in connection with the good faith performance of their duties to the Company, with the knowledge that certain costs, judgments, penalties, fines, liabilities and expenses incurred by them in their defense of such litigation are to be borne by the Company and they shall receive appropriate protection against such risks and liabilities, the Board of Directors of the Company has determined that the following Agreement is reasonable and prudent to promote and ensure the best interests of the Company and its stockholders; and
WHEREAS, the Company desires to have the Indemnitee continue to serve as a director or officer of the Company and in any other capacity with respect to the Company as the Company may request, as the case may be, free from undue concern for unpredictable, inappropriate, or unreasonable legal risks and personal liabilities by reason of the Indemnitee acting in good faith in the performance of the Indemnitees duty to the Company; and the Indemnitee desires to continue so to serve the Company, provided , and on the express condition, that he or she is furnished with the protections set forth hereinafter.
AGREEMENT
NOW, THEREFORE, in consideration of the Indemnitees continued service as a director or officer of the Company, the parties hereto agree as follows:
1. Definitions . For purposes of this Agreement:
(a) A Change in Control will be deemed to have occurred if, with respect to any particular 24-month period, the individuals who, at the beginning of such 24-month period, constituted the Board of Directors of the Company (the Incumbent Board ) cease for any reason to constitute at least a majority of the Board of Directors; provided , however , that any individual becoming a director subsequent to the beginning of such 24-month period whose election, or nomination for election by the stockholders of the Company, was approved by a vote of at least a majority of the directors then comprising the Incumbent Board shall be considered as though
1
such individual were a member of the Incumbent Board, but excluding, for this purpose, any such individual whose initial assumption of office occurs as a result of an actual or threatened election contest with respect to the election or removal of directors or other actual or threatened solicitation of proxies or consents by or on behalf of a person other than the Board of Directors.
(b) Disinterested Director means a director of the Company who is not or was not a party to the Proceeding in respect of which indemnification is being sought by the Indemnitee.
(c) Expenses includes, without limitation, expenses incurred in connection with the defense or settlement of any Proceeding (as defined below), attorneys fees, court costs, witness fees and expenses, fees and expenses of accountants and other advisors, retainers and disbursements and advances thereon, the premium, security for, and other costs relating to any bond (including cost bonds, appraisal bonds, or their equivalents), and any expenses of establishing a right to indemnification or advancement under Sections 9, 11, 13, and 16 hereof, but shall not include the amount of judgments, fines, ERISA excise taxes, or penalties actually levied against the Indemnitee, or any amounts paid in settlement by or on behalf of the Indemnitee.
(d) Independent Counsel means a law firm or a member of a law firm that neither is presently nor in the past 5 years has been retained to represent: (i) the Company or the Indemnitee in any matter material to either such party; or (ii) any other party to the Proceeding giving rise to a request for indemnification hereunder. Notwithstanding the foregoing, the term Independent Counsel shall not include any person who, under the applicable standards of professional conduct then prevailing, would have a conflict of interest in representing either the Company or the Indemnitee in an action to determine the Indemnitees right to indemnification under this Agreement.
(e) Proceeding means any action, suit, arbitration, alternative dispute resolution mechanism, investigation, inquiry, judicial, administrative or legislative hearing, or any other threatened, pending, or completed proceeding, whether brought by or in the right of the Company or otherwise, including any and all appeals, whether of a civil, criminal, administrative, legislative, investigative or other nature, to which the Indemnitee was or is a party or is threatened to be made a party or is otherwise involved in by reason of the fact that the Indemnitee is or was a director, officer, employee, agent or trustee of the Company or while a director, officer, employee, agent or trustee of the Company is or was serving at the request of the Company as a director, officer, employee, agent or trustee of another corporation or of a partnership, joint venture, trust or other enterprise, including service with respect to an employee benefit plan, or by reason of anything done or not done by the Indemnitee in any such capacity, whether or not the Indemnitee is serving in such capacity at the time any expense, liability, or loss is incurred for which indemnification or advancement can be provided under this Agreement.
2. Service by the Indemnitee . The Indemnitee shall serve and/or continue to serve as a director or officer of the Company faithfully and to the best of the Indemnitees ability so long as the Indemnitee is duly elected or appointed and until such time as the Indemnitees successor is elected and qualified or the Indemnitee is removed as permitted by applicable law or tenders a resignation in writing.
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3. Indemnification and Advancement of Expenses . The Company shall indemnify and hold harmless the Indemnitee, and shall pay to the Indemnitee in advance of the final disposition of any Proceeding all Expenses incurred by the Indemnitee, to the fullest extent authorized by existing or amended DGCL, all on the terms and conditions set forth in this Agreement. Without diminishing the scope of the rights provided by this Section, the rights of the Indemnitee to indemnification and advancement of Expenses provided hereunder shall include but shall not be limited to those rights hereinafter set forth, except that no indemnification or advancement of Expenses shall be paid to the Indemnitee:
(a) to the extent expressly prohibited by applicable law or the Certificate of Incorporation and Bylaws of the Company;
(b) to the extent that payment is actually made to the Indemnitee under a valid and collectible insurance policy or under a valid and enforceable indemnity clause, provision of the Certificate of Incorporation or Bylaws, or agreement of the Company or any other company or other enterprise (and the Indemnitee shall reimburse the Company for any amounts paid by the Company and subsequently so recovered by the Indemnitee); or
(c) in connection with an action, suit or proceeding, or part thereof voluntarily initiated by the Indemnitee (including claims and counterclaims, whether such counterclaims are asserted by: (i) the Indemnitee; or (ii) the Company in an action, suit, or proceeding initiated by the Indemnitee), except a judicial proceeding or arbitration pursuant to Section 11 to enforce rights under this Agreement, unless the action, suit, or proceeding, or part thereof, was authorized or ratified by the Board of Directors of the Company or the Board of Directors otherwise determines that indemnification or advancement of Expenses is appropriate.
4. Action or Proceedings Other than an Action by or in the Right of the Company . Except as limited by Section 3 above, the Indemnitee shall be entitled to the indemnification rights provided in this Section if the Indemnitee was or is a party or is threatened to be made a party to, or was or is otherwise involved in, any Proceeding (other than an action by or in the right of the Company) by reason of the fact that the Indemnitee is or was a director, officer, employee, agent, or trustee of the Company or while a director, officer, employee, agent, or trustee of the Company is or was serving at the request of the Company as a director, officer, employee, agent, or trustee of another corporation or of a partnership, joint venture, trust, or other enterprise, including service with respect to an employee benefit plan, or by reason of anything done or not done by the Indemnitee in any such capacity. Pursuant to this Section, the Indemnitee shall be indemnified against all expense, liability and loss (including judgments, fines, ERISA excise taxes, penalties, amounts paid in settlement by or on behalf of the Indemnitee and Expenses) actually and reasonably incurred by the Indemnitee in connection with such Proceeding, if the Indemnitee acted in good faith and in a manner the Indemnitee reasonably believed to be in or not opposed to the best interests of the Company, and with respect to any criminal Proceeding, had no reasonable cause to believe his or her conduct was unlawful.
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5. Indemnity in Proceedings by or in the Right of the Company . Except as limited by Section 3 above, the Indemnitee shall be entitled to the indemnification rights provided in this Section if the Indemnitee was or is a party or is threatened to be made a party to, or was or is otherwise involved in, any Proceeding brought by or in the right of the Company to procure a judgment in its favor by reason of the fact that the Indemnitee is or was a director, officer, employee, agent or trustee of the Company or while a director, officer, employee, agent or trustee of the Company is or was serving at the request of the Company as a director, officer, employee, agent or trustee of another corporation or of a partnership, joint venture, trust or other enterprise, including service with respect to an employee benefit plan, or by reason of anything done or not done by the Indemnitee in any such capacity. Pursuant to this Section, the Indemnitee shall be indemnified against all Expenses actually and reasonably incurred by the Indemnitee in connection with such Proceeding if the Indemnitee acted in good faith and in a manner the Indemnitee reasonably believed to be in or not opposed to the best interests of the Company; provided , however , that no such indemnification shall be made in respect of any claim, issue or matter as to which the DGCL expressly prohibits such indemnification by reason of any adjudication of liability of the Indemnitee to the Company, unless and only to the extent that the Court of Chancery of the State of Delaware or the court in which such Proceeding was brought shall determine upon application that, despite the adjudication of liability but in view of all the circumstances of the case, the Indemnitee is entitled to indemnification for such expense, liability, and loss as such court shall deem proper.
6. Indemnification for Costs, Charges and Expenses of Successful Party . Notwithstanding any limitations of Sections 3(c), 4 and 5 above, to the extent that the Indemnitee has been successful, on the merits or otherwise, in whole or in part, in defense of any Proceeding, or in defense of any claim, issue, or matter therein, including, without limitation, the dismissal of any action without prejudice, or if it is ultimately determined, by final judicial decision of a court of competent jurisdiction from which there is no further right to appeal, that the Indemnitee is otherwise entitled to be indemnified against Expenses, the Indemnitee shall be indemnified against all Expenses actually and reasonably incurred by the Indemnitee in connection therewith.
7. Partial Indemnification . If the Indemnitee is entitled under any provision of this Agreement to indemnification by the Company for some or a portion of the expense, liability and loss (including judgments, fines, ERISA excise taxes, penalties, amounts paid in settlement by or on behalf of the Indemnitee and Expenses) actually and reasonably incurred in connection with any Proceeding, or in connection with any judicial proceeding or arbitration pursuant to Section 11 to enforce rights under this Agreement, but not for the total amount thereof, the Company shall nevertheless indemnify the Indemnitee for the portion of such expense, liability and loss actually and reasonably incurred to which the Indemnitee is entitled.
8. Indemnification for Expenses of a Witness . Notwithstanding any other provision of this Agreement, to the maximum extent permitted by the DGCL, the Indemnitee shall be entitled to indemnification against all Expenses actually and reasonably incurred by the Indemnitee or on the Indemnitees behalf if the Indemnitee appears as a witness or otherwise incurs legal expenses as a result of or related to the Indemnitees service as a director or officer of the Company, in any threatened, pending, or completed action, suit, arbitration, alternative dispute resolution mechanism, investigation, inquiry, judicial, administrative or legislative hearing, or any other threatened, pending or completed proceeding, whether of a civil, criminal, administrative, legislative, investigative or other nature, to which the Indemnitee neither is, nor is threatened to be made, a party.
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9. Determination of Entitlement to Indemnification . To receive indemnification under this Agreement, the Indemnitee shall submit a written request to the Company. Such request shall include documentation or information that is reasonably necessary for such determination and is reasonably available to the Indemnitee. Upon receipt by the Company of a written request by the Indemnitee for indemnification, the entitlement of the Indemnitee to indemnification, to the extent not required pursuant to the terms of Section 6 or Section 8 of this Agreement, shall be determined by the following person or persons who shall be empowered to make such determination (as selected by the Board of Directors, except with respect to Section 9(e) below): (a) the Board of Directors of the Company by a majority vote of Disinterested Directors, whether or not such majority constitutes a quorum; (b) a committee of Disinterested Directors designated by a majority vote of such directors, whether or not such majority constitutes a quorum; (c) if there are no Disinterested Directors, or if the Disinterested Directors so direct, by Independent Counsel in a written opinion to the Board of Directors, a copy of which shall be delivered to the Indemnitee; (d) the stockholders of the Company; or (e) in the event that a Change in Control has occurred, by Independent Counsel in a written opinion to the Board of Directors, a copy of which shall be delivered to the Indemnitee. Such Independent Counsel shall be selected by the Board of Directors and approved by the Indemnitee, except that in the event that a Change in Control has occurred, Independent Counsel shall be selected by the Indemnitee. Upon failure of the Board of Directors so to select such Independent Counsel or upon failure of the Indemnitee so to approve (or so to select, in the event a Change in Control has occurred), such Independent Counsel shall be selected upon application to a court of competent jurisdiction. The determination of entitlement to indemnification shall be made and, unless a contrary determination is made, such indemnification shall be paid in full by the Company not later than 60 calendar days after receipt by the Company of a written request for indemnification. If the person making such determination shall determine that the Indemnitee is entitled to indemnification as to part (but not all) of the application for indemnification, such person shall reasonably prorate such partial indemnification among the claims, issues, or matters at issue at the time of the determination.
10. Presumptions and Effect of Certain Proceedings . The Secretary of the Company shall, promptly upon receipt of the Indemnitees written request for indemnification, advise in writing the Board of Directors or such other person or persons empowered to make the determination as provided in Section 9 that the Indemnitee has made such request for indemnification. Upon making such request for indemnification, the Indemnitee shall be presumed to be entitled to indemnification hereunder and the Company shall have the burden of proof in making any determination contrary to such presumption. If the person or persons so empowered to make such determination shall have failed to make the requested determination with respect to indemnification within 60 calendar days after receipt by the Company of such request, a requisite determination of entitlement to indemnification shall be deemed to have been made and the Indemnitee shall be absolutely entitled to such indemnification, absent actual fraud in the request for indemnification. The termination of any Proceeding described in Sections 4 or 5 by judgment, order, settlement or conviction, or upon a plea of nolo contendere or its equivalent, shall not, of itself: (a) create a presumption that the Indemnitee did not act in good
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faith and in a manner the Indemnitee reasonably believed to be in or not opposed to the best interests of the Company, and with respect to any criminal Proceeding, had reasonable cause to believe his or her conduct was unlawful; or (b) otherwise adversely affect the rights of the Indemnitee to indemnification except as may be provided herein.
11. Remedies of the Indemnitee in Cases of Determination Not to Indemnify or to Advance Expenses; Right to Bring Suit . In the event that a determination is made that the Indemnitee is not entitled to indemnification hereunder or if payment is not timely made following a determination of entitlement to indemnification pursuant to Sections 9 and 10, or if an advancement of Expenses is not timely made pursuant to Section 16, the Indemnitee may at any time thereafter bring suit against the Company seeking an adjudication of entitlement to such indemnification or advancement of Expenses, and any such suit shall be brought in the Court of Chancery of the State of Delaware unless otherwise required by the law of the state in which the Indemnitee primarily resides and works. Alternatively, the Indemnitee at the Indemnitees option may seek an award in an arbitration to be conducted by a single arbitrator in the State of Delaware pursuant to the rules of the American Arbitration Association, such award to be made within 60 calendar days following the filing of the demand for arbitration. The Company shall not oppose the Indemnitees right to seek any such adjudication or award in arbitration. In any suit or arbitration brought by the Indemnitee to enforce a right to indemnification hereunder (but not in a suit or arbitration brought by the Indemnitee to enforce a right to an advancement of Expenses), it shall be a defense that the Indemnitee has not met any applicable standard of conduct for indemnification set forth in the DGCL, including the standard described in Section 4 or 5, as applicable. Further, in any suit brought by the Company to recover an advancement of Expenses pursuant to the terms of an undertaking, the Company shall be entitled to recover such Expenses upon a final judicial decision of a court of competent jurisdiction from which there is no further right to appeal that the Indemnitee has not met the standard of conduct described above. Neither the failure of the Company (including the Disinterested Directors, a committee of Disinterested Directors, Independent Counsel, or its stockholders) to have made a determination prior to the commencement of such suit or arbitration that indemnification of the Indemnitee is proper in the circumstances because the Indemnitee has met the standard of conduct described above, nor an actual determination by the Company (including the Disinterested Directors, a committee of Disinterested Directors, Independent Counsel, or its stockholders) that the Indemnitee has not met the standard of conduct described above shall create a presumption that the Indemnitee has not met the standard of conduct described above, or, in the case of such a suit brought by the Indemnitee, be a defense to such suit. In any suit brought by the Indemnitee to enforce a right to indemnification or to an advancement of Expenses hereunder, or brought by the Company to recover an advancement of Expenses pursuant to the terms of an undertaking, the burden of proving that the Indemnitee is not entitled to be indemnified, or to such advancement of expenses, under this Section 11 or otherwise shall be on the Company. If a determination is made or deemed to have been made pursuant to the terms of Section 9 or 10 that the Indemnitee is entitled to indemnification, the Company shall be bound by such determination and is precluded from asserting that such determination has not been made or that the procedure by which such determination was made is not valid, binding, and enforceable. The Company further agrees to stipulate in any court or before any arbitrator pursuant to this Section 11 that the Company is bound by all the provisions of this Agreement and is precluded from making any assertions to the contrary. If the court or arbitrator shall determine that the Indemnitee is entitled to any indemnification or advancement of Expenses hereunder, the Company shall pay all
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Expenses actually and reasonably incurred by the Indemnitee in connection with such adjudication or award in arbitration (including, but not limited to, any appellate proceedings) to the fullest extent permitted by law, and in any suit brought by the Company to recover an advancement of Expenses pursuant to the terms of an undertaking, the Company shall pay all Expenses actually and reasonably incurred by the Indemnitee in connection with such suit to the extent the Indemnitee has been successful, on the merits or otherwise, in whole or in part, in defense of such suit, to the fullest extent permitted by law.
12. Non-Exclusivity of Rights . The rights to indemnification and to the advancement of Expenses provided by this Agreement shall not be deemed exclusive of any other right that the Indemnitee may now or hereafter acquire under any applicable law, agreement, vote of stockholders or Disinterested Directors, provisions of a charter or Bylaws (including the Certificate of Incorporation or Bylaws of the Company), or otherwise.
13. Expenses to Enforce Agreement . In the event that the Indemnitee is subject to or intervenes in any action, suit or proceeding in which the validity or enforceability of this Agreement is at issue or seeks an adjudication or award in arbitration to enforce the Indemnitees rights under, or to recover damages for breach of, this Agreement, the Indemnitee, if the Indemnitee prevails in whole or in part in such action, suit, or proceeding, shall be entitled to recover from the Company and shall be indemnified by the Company against any Expenses actually and reasonably incurred by the Indemnitee in connection therewith.
14. Continuation of Indemnity . All agreements and obligations of the Company contained herein shall continue during the period the Indemnitee is a director, officer, employee, agent or trustee of the Company or while a director, officer, employee, agent or trustee is serving at the request of the Company as a director, officer, employee, agent or trustee of another corporation or of a partnership, joint venture, trust or other enterprise, including service with respect to an employee benefit plan, and shall continue thereafter with respect to any possible claims based on the fact that the Indemnitee was a director, officer, employee, agent or trustee of the Company or was serving at the request of the Company as a director, officer, employee, agent or trustee of another corporation or of a partnership, joint venture, trust or other enterprise, including service with respect to an employee benefit plan. This Agreement shall be binding upon all successors and assigns of the Company (including any transferee of all or substantially all of its assets and any successor by merger or operation of law) and shall inure to the benefit of the Indemnitees heirs, executors and administrators.
15. Notification and Defense of Proceeding . Promptly after receipt by the Indemnitee of notice of any Proceeding, the Indemnitee shall, if a request for indemnification or an advancement of Expenses in respect thereof is to be made against the Company under this Agreement, notify the Company in writing of the commencement thereof; but the omission so to notify the Company shall not relieve it from any liability that it may have to the Indemnitee. Notwithstanding any other provision of this Agreement, with respect to any such Proceeding of which the Indemnitee notifies the Company:
(a) The Company shall be entitled to participate therein at its own expense;
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(b) Except as otherwise provided in this Section 15(b), to the extent that it may wish, the Company, jointly with any other indemnifying party similarly notified, shall be entitled to assume the defense thereof, with counsel satisfactory to the Indemnitee. After notice from the Company to the Indemnitee of its election so to assume the defense thereof, the Company shall not be liable to the Indemnitee under this Agreement for any expenses of counsel subsequently incurred by the Indemnitee in connection with the defense thereof except as otherwise provided below. The Indemnitee shall have the right to employ the Indemnitees own counsel in such Proceeding, but the fees and expenses of such counsel incurred after notice from the Company of its assumption of the defense thereof shall be at the expense of the Indemnitee unless: (i) the employment of counsel by the Indemnitee has been authorized by the Company; (ii) the Indemnitee shall have reasonably concluded that there may be a conflict of interest between the Company and the Indemnitee in the conduct of the defense of such Proceeding; or (iii) the Company has not, within 60 calendar days of receipt of notice from the Indemnitee, employed counsel to assume the defense of the Proceeding; in each of which cases the fees and expenses of the Indemnitees counsel shall be at the expense of the Company. The Company shall not be entitled to assume the defense of any Proceeding brought by or on behalf of the Company or as to which the Indemnitee shall have made the conclusion provided for in (ii) above; and
(c) Notwithstanding any other provision of this Agreement, the Company shall not be liable to indemnify the Indemnitee under this Agreement for any amounts paid in settlement of any Proceeding effected without the Companys written consent, or for any judicial or other award, if the Company was not given an opportunity, in accordance with this Section 15, to participate in the defense of such Proceeding. The Company shall not settle any Proceeding in any manner that would impose any penalty or limitation on or disclosure obligation with respect to the Indemnitee, or that would directly or indirectly constitute or impose any future obligation, admission or acknowledgment of fault or culpability with respect to the Indemnitee, without the Indemnitees written consent. Neither the Company nor the Indemnitee shall unreasonably withhold its consent to any proposed settlement.
16. Advancement of Expenses . All Expenses incurred by the Indemnitee in defending any Proceeding described in Section 4 or 5 shall be paid by the Company in advance of the final disposition of such Proceeding at the request of the Indemnitee. The Indemnitees right to advancement shall not be subject to the satisfaction of any standard of conduct and advances shall be made without regard to the Indemnitees ultimate entitlement to indemnification under the provisions of this Agreement or otherwise. To receive an advancement of Expenses under this Agreement, the Indemnitee shall submit a written request to the Company. Such request shall reasonably evidence the Expenses incurred by the Indemnitee and shall include or be accompanied by an undertaking, by or on behalf of the Indemnitee, to repay all amounts so advanced if it shall ultimately be determined, by final judicial decision of a court of competent jurisdiction from which there is no further right to appeal, that the Indemnitee is not entitled to be indemnified for such Expenses by the Company as provided by this Agreement or otherwise. The Indemnitees undertaking to repay any such amounts is not required to be secured. Each such advancement of Expenses shall be made within 20 calendar days after the receipt by the Company of such written request. The Indemnitees entitlement to Expenses under this Agreement shall include those incurred in connection with any action, suit, or proceeding by the Indemnitee seeking an adjudication or award in arbitration pursuant to Section 11 of this Agreement (including the enforcement of this provision) to the extent the court or arbitrator shall determine that the Indemnitee is entitled to an advancement of Expenses hereunder.
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17. Severability; Prior Indemnification Agreements . If any provision or provisions of this Agreement shall be held to be invalid, illegal or unenforceable as applied to any person or entity or circumstance for any reason whatsoever, then, to the fullest extent permitted by law: (a) the validity, legality, and enforceability of such provision in any other circumstance and of the remaining provisions of this Agreement (including, without limitation, all portions of any paragraphs of this Agreement containing any such provision held to be invalid, illegal, or unenforceable, that are not by themselves invalid, illegal, or unenforceable) and the application of such provision to other persons or entities or circumstances shall not in any way be affected or impaired thereby; and (b) to the fullest extent possible, the provisions of this Agreement (including, without limitation, all portions of any paragraph of this Agreement containing any such provision held to be invalid, illegal, or unenforceable, that are not themselves invalid, illegal, or unenforceable) shall be construed so as to give effect to the intent of the parties that the Company provide protection to the Indemnitee to the fullest extent set forth in this Agreement. This Agreement shall supersede and replace any prior indemnification agreements, including the Fifth Amended Restated Limited Liability Company Agreement of the Company, entered into by and between the Company and the Indemnitee and any such prior agreements shall be terminated upon execution of this Agreement.
18. Headings; References; Pronouns . The headings of the sections of this Agreement are inserted for convenience only and shall not be deemed to constitute part of this Agreement or to affect the construction thereof. References herein to section numbers are to sections of this Agreement. All pronouns and any variations thereof shall be deemed to refer to the singular or plural as appropriate.
19. Other Provisions .
(a) This Agreement and all disputes or controversies arising out of or related to this Agreement shall be governed by, and construed in accordance with, the internal laws of the State of Delaware, without regard to the laws of any other jurisdiction that might be applied because of conflicts of laws principles of the State of Delaware, unless otherwise required by the law of the state in which the Indemnitee primarily resides and works.
(b) This Agreement may be executed in two or more counterparts, all of which shall be considered one and the same instrument and shall become effective when one or more counterparts have been signed by each of the parties and delivered to the other party.
(c) This Agreement shall not be deemed an employment contract between the Company and any Indemnitee who is an officer of the Company, and, if the Indemnitee is an officer of the Company, the Indemnitee specifically acknowledges that the Indemnitee may be discharged at any time for any reason, with or without cause, and with or without severance compensation, except as may be otherwise provided in a separate written contract between the Indemnitee and the Company.
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(d) In the event of payment under this Agreement, the Company shall be subrogated to the extent of such payment to all of the rights of recovery of the Indemnitee (excluding insurance obtained on the Indemnitees own behalf), and the Indemnitee shall execute all papers required and shall do everything that may be necessary to secure such rights, including the execution of such documents necessary to enable the Company effectively to bring suit to enforce such rights.
(e) This Agreement may not be amended, modified, or supplemented in any manner, whether by course of conduct or otherwise, except by an instrument in writing specifically designated as an amendment hereto, signed on behalf of each party. No failure or delay of either party in exercising any right or remedy hereunder shall operate as a waiver thereof, and no single or partial exercise of any such right or power, or any abandonment or discontinuance of steps to enforce such right or power, or any course of conduct, shall preclude any other or further exercise thereof or the exercise of any other right or power.
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IN WITNESS WHEREOF, the Company and the Indemnitee have caused this Agreement to be executed as of the date first written above.
Odonate Therapeutics, Inc. | ||
By: | ||
Name: | ||
Title: |
Indemnitee |
S IGNATURE P AGE TO I NDEMNIFICATION A GREEMENT
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the use in this Registration Statement (No. 333-221533) on Form S-1 of Odonate Therapeutics, LLC of our report dated September 29, 2017, relating to the financial statements of Odonate Therapeutics, LLC, appearing in the Prospectus, which is part of this Registration Statement.
We also consent to the reference to our firm under the headings Experts in such Prospectus.
/s/ SQUAR MILNER LLP
San Diego, California
November 27, 2017