As filed with the Securities and Exchange Commission on December 28, 2017.
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
Menlo Therapeutics Inc.
(Exact name of Registrant as specified in its charter)
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Delaware
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2834
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45-3757789
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(State or other jurisdiction of
incorporation or organization)
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(Primary Standard Industrial
Classification Code Number)
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(I.R.S. Employer
Identification Number)
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200 Cardinal Way, 2nd Floor
Redwood City, California 94063
(650) 486-1416
(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)
Steven L. Basta
President and Chief Executive Officer
Menlo Therapeutics Inc.
200 Cardinal Way, 2nd Floor
Redwood City, California 94063
(650) 486-1416
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies to:
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Stephen B. Thau
Alfredo B. D. Silva
Shannon E. Sibold
Morrison & Foerster LLP
755 Page Mill Road
Palo Alto, California 94304
Telephone: (650) 813-5600
Facsimile: (650) 494-0792
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Alan C. Mendelson
Mark V. Roeder
Brian J. Cuneo
Latham & Watkins LLP
140 Scott Drive
Menlo Park, California 94025
Telephone: (650) 328-4600
Facsimile: (650) 463-2600
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Approximate date of commencement of proposed sale to the public:
As soon as practicable after the effective date of this Registration Statement.
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, please 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, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer
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☐
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Accelerated filer
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☐
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Non-accelerated filer
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☒ (Do not check if a smaller reporting company)
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Smaller reporting company
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☐
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Emerging growth company
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided 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
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Proposed
Maximum
Aggregate
Offering Price
(1)(2)
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Amount of
Registration Fee
(2)
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Common Stock, $0.0001 par value per share
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$ 97,750,000
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$ 12,169.88
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(1)
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Includes a base offering of $85,000,000 of shares of common stock and $12,750,000 of shares of common stock that the underwriters have the option to purchase. Estimated solely for the purpose of calculating the amount of the registration fee in accordance with Rule 457(o) under the Securities Act of 1933, as amended.
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(2)
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Estimated solely for the purpose of calculating the amount of the registration fee in accordance with Rule 457(o) under the Securities Act of 1933, as amended.
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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 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
The information in this preliminary 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 preliminary prospectus is not an offer to sell these securities 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 December 28, 2017
Preliminary Prospectus
Shares
Common Stock
This is Menlo Therapeutics Inc.’s initial public offering. We are offering shares of our common stock.
We expect that the initial public offering price will be between $ and $ per share. Currently, no public market exists for our common stock. We have applied to have our common stock approved for listing on the Nasdaq Global Market under the symbol “MNLO.”
We are an “emerging growth company” as defined in Section 2(a) of the Securities Act of 1933, as amended, or the Securities Act, and will be subject to reduced public company reporting requirements. See “Prospectus Summary —Implications of Being an Emerging Growth Company.”
Investing in our common stock involves a high degree of risks. Please read “Risk Factors” beginning on page 9 of this prospectus.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
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Per Share
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Total
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Public offering price
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$
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$
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Underwriting discounts and commissions
(1)
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$
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$
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Proceeds, before expenses, to us
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$
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$
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(1)
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We refer you to “Underwriting” beginning on page 140 for additional disclosure regarding total underwriting compensation.
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Delivery of the shares of common stock is expected to be made on or about , 2018 through the book-entry facilities of The Depository Trust Company. We have granted the underwriters an option for a period of 30 days to purchase up to an additional shares of our common stock. If the underwriters exercise the option in full, the total underwriting discounts and commissions payable by us will be $ , and the total proceeds to us, before estimated expenses, will be $ .
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Joint Book‑Running Managers
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Jefferies
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Piper Jaffray
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Guggenheim Securities
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Lead Manager
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JMP Securities
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Prospectus dated , 2018
TABLE OF CONTENTS
Neither we nor the underwriters have authorized anyone to provide you with information that is different from that contained in this prospectus or in any free writing prospectus we may authorize to be delivered or made available to you. We and the underwriters take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. We and the underwriters are offering to sell shares of common stock and seeking offers to buy shares of common stock only in jurisdictions where offers and sales are permitted. The information contained in this prospectus is accurate only as of the date on the front of this prospectus, or other earlier date stated in this prospectus, regardless of the time of delivery of this prospectus or any sale of shares of our common stock.
No action is being taken in any jurisdiction outside the United States to permit a public offering of our common stock or possession or distribution of this prospectus in that jurisdiction. Persons who come into possession of this prospectus in jurisdictions outside the United States are required to inform themselves about and to observe any restrictions as to this offering and the distribution of this prospectus applicable to that jurisdiction. Through and including , 2018 (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 delivery requirement is in addition to a dealer’s obligation to deliver a prospectus when acting as an underwriter and with respect to an unsold allotment or subscription.
Menlo Therapeutics™ and our logo are some of our trademarks used in this prospectus. This prospectus also includes trademarks, tradenames and service marks that are the property of other organizations. Solely for convenience, our trademarks and tradenames referred to in this prospectus may appear without the
®
and ™ symbol, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or the right of the applicable licensor to these trademarks and tradenames.
PROSPECTUS SUMMARY
This summary highlights information contained elsewhere in this prospectus and does not contain all of the information that you should consider in making your investment decision. Before deciding to invest in our common stock, you should read this entire prospectus carefully, including the sections of this prospectus entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes contained elsewhere in this prospectus. Unless the context otherwise requires or as otherwise noted, references in this prospectus to the “Company,” “Menlo Therapeutics,” “we,” “us,” and “our” refer to Menlo Therapeutics Inc.
Overview
We are a late‑stage biopharmaceutical company focused on the development and commercialization of serlopitant for the treatment of pruritus, or itch, associated with dermatologic conditions such as atopic dermatitis, psoriasis and prurigo nodularis. We are concurrently evaluating the use of serlopitant for the treatment of refractory chronic cough, a cough that persists for greater than eight weeks despite treatment of any identified underlying cause. We believe that serlopitant, a highly selective small molecule inhibitor of the neurokinin 1 receptor, or NK
1
‑R, given as a once‑daily, oral tablet, has the potential to significantly alleviate pruritus and refractory chronic cough symptoms.
Pruritus is the primary patient complaint among atopic dermatitis, psoriasis and prurigo nodularis patients and represents a significant patient need. There are currently no therapies approved in the United States that are primarily intended to reduce the pruritus associated with these conditions. Refractory chronic cough also represents a significant opportunity, with no drugs specifically approved for this indication in the United States. We believe that serlopitant, if approved, could easily fit into the current treatment regimen for our target indications. We believe that serlopitant may be effective as an oral therapy adjunct to standard of care topical or systemic treatments for pruritic dermatologic conditions, and may also be effective as a monotherapy for patients for whom management of the pruritus or refractory chronic cough symptoms is the primary patient need.
We have initiated a broad clinical development program for serlopitant. We expect data from our ongoing Phase 2 clinical trial in pruritus associated with atopic dermatitis in the second quarter of 2018 and from our ongoing Phase 2 clinical trials in pruritus associated with psoriasis and refractory chronic cough by late 2018 or early 2019. We plan to initiate two Phase 3 clinical trials in pruritus associated with prurigo nodularis in the first half of 2018, with results expected in the first half of 2020. If these and future trials we may initiate are successful, we could potentially submit a New Drug Application, or NDA, for up to three indications in 2020: pruritus associated with atopic dermatitis, psoriasis and prurigo nodularis. Our development pipeline is summarized in the figure below:
We have completed two double‑blind Phase 2 clinical trials in over 380 patients with pruritus and observed clinically relevant and statistically significant improvements in pruritus in patients treated with serlopitant compared with patients treated with placebo. The first Phase 2 clinical trial, conducted in 257 patients with chronic pruritus, met its primary and multiple secondary efficacy endpoints of pruritus reduction for patients treated at our two highest doses (5 mg and 1 mg daily). At week six, for the primary efficacy analysis, the serlopitant 5 mg group and the serlopitant 1 mg group showed an improvement in pruritus of 42.5% and 41.4% from baseline, respectively, measured by the itch visual analog scale, or VAS. Each represents a statistically greater improvement compared with the placebo group improvement of 28.3% (5 mg, p = 0.013; 1 mg, p = 0.022). The second Phase 2 clinical trial, conducted in 127 patients with prurigo nodularis, a severely pruritic skin condition with lesions, also met its primary and multiple secondary efficacy endpoints demonstrating significant pruritus reduction. At week eight, for the primary efficacy analysis, the serlopitant 5 mg group showed a 36 mm improvement from baseline in average itch VAS score compared with a 19 mm improvement for the placebo group (p = 0.001). Serlopitant has been dosed in more than 1,000 individuals and has been shown to be well‑tolerated, including when administered to patients in a clinical trial for up to one year.
The primary efficacy results from our completed Phase 2 pruritus clinical trials are illustrated in the figures below:
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Chronic Pruritus Phase 2 Clinical Trial (N=257)
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Prurigo Nodularis Phase 2 Clinical Trial (N=127)
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To report itch severity on the VAS, patients place a mark on a 100 mm line corresponding to the degree of severity of their pruritus. The distance from the origin of the line is measured to indicate pruritus severity, where 0 mm represents no itch and 100 mm represents the worst itch imaginable.
Our Strategy
Our goal is to become a fully integrated biopharmaceutical company focused on the development and commercialization of serlopitant. The key elements of our strategy are to:
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Obtain regulatory approval for serlopitant for the treatment of pruritus associated with multiple highly pruritic dermatologic conditions.
We plan to focus on the near‑term development and potential regulatory approval and commercialization of serlopitant for the treatment of pruritus associated with multiple dermatologic conditions. Following our discussions with the United States Food and Drug Administration, or FDA, and European regulatory agencies, we are advancing into Phase 3 clinical trials for the treatment of pruritus associated with prurigo nodularis. We have also commenced Phase 2 clinical trials for the treatment of pruritus associated with atopic dermatitis and psoriasis. If the results of these trials are promising, we intend to rapidly advance into Phase 3 clinical trials for these indications, with the goal of seeking regulatory approval in the United States and Europe.
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Build a specialty sales organization to commercialize and market serlopitant in the United States, if approved
. If approved by the FDA for pruritus associated with our target dermatologic conditions, we
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intend to commercialize serlopitant by developing our own sales organization targeting a subset of the 10,000 to 12,000 dermatologists in the United States. If approved for pruritus associated with atopic dermatitis, we anticipate that we may need to expand this sales organization to reach high prescribing pediatricians and primary care physicians. Outside the United States, we intend to establish commercialization strategies for serlopitant as we approach possible commercial approval in each market, which may include collaborations with other companies.
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Develop serlopitant to treat refractory chronic cough
. We believe that the mechanistic overlap of the NK
1
‑R pathway in the pathology of pruritus and cough supports the development of serlopitant as a potentially efficacious therapy for patients suffering from refractory chronic cough. Our program builds upon data from several proof of concept studies with other NK
1
‑R antagonists. We are evaluating the efficacy and safety of serlopitant in our ongoing Phase 2 clinical trial for refractory chronic cough.
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Leverage our development and commercial infrastructure to expand our pipeline over time.
We may elect in the future to pursue additional indications for serlopitant or in‑license or acquire drug candidates or commercial products that leverage our development or commercial capabilities.
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Management
Members of our management team have extensive experience in product development, having held drug development, commercial and leadership roles at numerous biopharmaceutical and dermatology products companies, including Genentech/Roche, Gilead Sciences, Millennium Pharmaceuticals (acquired by Takeda), Relypsa (acquired by Galenica), Anacor Pharmaceuticals (acquired by Pfizer), Medicis Pharmaceutical (acquired by Valeant), Connetics Corporation (acquired by Stiefel, now a division of GSK), BioForm Medical (acquired by Merz) and Merz Aesthetics. At their prior companies, our management team members have been involved in product development or commercialization of many successful dermatology products.
Risks Factors
Our ability to implement our business strategy is subject to numerous risks that you should be aware of before making an investment decision. These risks are described more fully in the section entitled “Risk Factors” immediately following this prospectus summary. These risks include the following, among others:
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We have a limited operating history, have incurred significant losses since our inception and anticipate that we will continue to incur losses for the foreseeable future. We have only one product candidate in clinical trials and no commercial sales, which, together with our limited operating history, makes it difficult to assess our future viability.
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We will require substantial additional financing and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development, other operations or commercialization efforts.
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We are substantially dependent on the success of our sole product candidate, serlopitant.
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Clinical drug development involves a lengthy and expensive process with an uncertain outcome.
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Success in non‑clinical testing and early clinical trials does not ensure that later clinical trials will be successful.
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The regulatory approval process is highly uncertain and we may not obtain regulatory approval for the commercialization of serlopitant.
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We may not be successful in our efforts to obtain regulatory approval of serlopitant in multiple indications concurrently or at all.
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We rely on third parties to conduct our non-clinical studies and our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for or commercialize serlopitant.
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We rely completely on third‑party suppliers to manufacture serlopitant, and we intend to continue to rely on third parties to produce non-clinical, clinical and commercial supplies of serlopitant.
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We currently have no sales organization. If we are unable to establish sales capabilities on our own or through third parties, we may not be able to market and sell serlopitant, if approved, or generate product revenue.
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We may become subject to claims alleging infringement of third parties’ patents or proprietary rights and/or claims seeking to invalidate our patents, which would be costly, time consuming and, if successfully asserted against us, delay or prevent the development and commercialization of serlopitant.
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Corporate Information
We were incorporated in October 2011 as a Delaware corporation under the name Tigercat Pharma, Inc. In May 2016, we changed our name to Menlo Therapeutics Inc. Our principal executive offices are located at 200 Cardinal Way, 2nd Floor, Redwood City, CA 94063 and our telephone number is (650) 486-1416. Our website is www.menlotherapeutics.com. The information contained on, or that can be accessed through, our website is not incorporated by reference into this prospectus. We have included our web address as an inactive textual reference only.
Implications of Being an Emerging Growth Company
We qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. An emerging growth company may take advantage of relief from some of the reporting requirements and other burdens that are otherwise applicable generally to public companies. These provisions include:
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presentation of only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in this prospectus;
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exemption from the auditor attestation requirement on the effectiveness of our internal controls over financial reporting;
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reduced disclosure about our executive compensation arrangements in our periodic reports, proxy statements and registration statements; and
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no requirements for non‑binding advisory votes on executive compensation or golden parachute arrangements.
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We may take advantage of these provisions for up to five years or such earlier time that we no longer qualify as an emerging growth company. We would cease to be an emerging growth company if we have more than $1.07 billion in annual revenue, have more than $700 million in market value of our capital stock held by non‑affiliates or issue more than $1.0 billion of non‑convertible debt over a three‑year period. We may choose to take advantage of some but not all of these reduced burdens. For example, we have taken advantage of the reduced reporting requirements with respect to disclosure regarding our executive compensation arrangements, have presented only two years of audited financial statements and only two years of related “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in this prospectus, and have taken advantage of the exemption from auditor attestation on the effectiveness of our internal control over financial reporting. To the extent that we take advantage of these reduced burdens, the information that we provide stockholders may be different than you might obtain from other public companies in which you hold equity interests.
In addition, under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards 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, we will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
THE OFFERING
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Issuer
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Menlo Therapeutics Inc.
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Common stock offered by us
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shares.
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Common stock to be outstanding
after the offering
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shares.
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Underwriters’ option to purchase
additional shares
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shares.
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Use of proceeds
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We estimate that the net proceeds from this offering will be approximately $ million, or approximately $ million if the underwriters exercise their option to purchase additional shares in full, at the assumed initial public offering price of $ per share, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
We currently expect to use the net proceeds from this offering: (i) to complete our ongoing Phase 2 clinical trials of serlopitant for pruritus associated with atopic dermatitis and psoriasis, and for refractory chronic cough; (ii) to significantly advance our planned Phase 3 development of serlopitant for pruritus associated with prurigo nodularis; (iii) to supply serlopitant for our clinical trials and for development and validation of our commercial manufacturing process for serlopitant in preparation for our NDA and Marketing Authorization Application, or MAA, submissions; (iv) $3.0 million for a milestone payment to Merck Sharp & Dohme Corp., or Merck, associated with initiating a Phase 3 clinical trial; and (v) the remainder for personnel expenses, other development activities, including potentially commencing Phase 3 clinical trials for pruritus associated with atopic dermatitis and psoriasis and for refractory chronic cough, working capital, and other general corporate purposes, including the costs of operating as a public company. See “Use of Proceeds” on page 48 for a more complete description of the intended use of proceeds from this offering.
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Risk factors
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See “Risk Factors” beginning on page 9 and other information included in this prospectus for a discussion of factors that you should consider carefully before deciding to invest in our common stock.
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Proposed Nasdaq Global Market symbol
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“MNLO”
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The number of shares of common stock to be outstanding after this offering is based on 40,268,326 shares of common stock outstanding as of September 30, 2017, including an aggregate of 25,975,346 shares of common stock issuable upon conversion of our outstanding preferred stock, which will automatically convert on a one‑to‑one basis immediately prior to the completion of this offering, and excludes the following:
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5,807,569 shares of common stock issuable upon the exercise of outstanding stock options as of September 30, 2017 having a weighted‑average exercise price of $1.07 per share;
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665,606 shares of common stock reserved for issuance pursuant to future awards under our 2011 Stock Incentive Plan as of September 30, 2017, which will no longer be available for issuance effective on the day prior to the first public trading date of our common stock;
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shares of common stock to be reserved for issuance pursuant to future awards under our 2018 Omnibus Incentive Plan, as well as any automatic increases in the number of shares of our common stock reserved for future issuance under this plan, which will become effective on the day prior to the first public trading date of our common stock; and
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shares of common stock to be reserved for issuance pursuant to our 2018 Employee Stock Purchase Plan, as well as any automatic increases in the number of shares of our common stock reserved for future issuance under this plan, which will become effective on the day prior to the first public trading date of our common stock.
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In addition, unless we specifically state otherwise, all information in this prospectus assumes:
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a 1‑for‑ reverse stock split of our capital stock;
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the automatic conversion of all shares of our outstanding preferred stock at September 30, 2017 into an aggregate of 25,975,346 shares of common stock immediately prior to the completion of this offering;
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the filing and effectiveness of our amended and restated certificate of incorporation in Delaware and the adoption of our amended and restated bylaws, each of which will occur immediately prior to the completion of this offering;
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no exercise of outstanding stock options at September 30, 2017; and
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no exercise of the underwriters’ option to purchase additional shares of common stock.
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Unless otherwise specified and unless the context otherwise requires, we refer to our Series A, Series B and Series C convertible preferred stock collectively as “convertible preferred stock” or “preferred stock” in this prospectus, as well as for financial reporting purposes and in the financial tables included in this prospectus, as more fully explained in Note 6 to our audited financial statements included in this prospectus.
SUMMARY FINANCIAL DATA
The following tables set forth a summary of our historical financial data as of and for the periods indicated. We have derived the summary statements of operations data for the years ended December 31, 2015 and 2016 from our audited financial statements included elsewhere in this prospectus. We have derived the summary statements of operations data for the nine months ended
September 30, 2016
and
2017
, and the summary balance sheet data as of
September 30, 2017
from our unaudited interim financial statements included elsewhere in this prospectus. We have prepared the unaudited interim financial statements on the same basis as the audited financial statements and have included, in our opinion, all adjustments, consisting only of normal recurring adjustments that we consider necessary for a fair statement of the financial information set forth in those statements. You should read this data together with our financial statements and related notes appearing elsewhere in this prospectus and the information under the captions “Selected Financial Data” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” The summary financial data included in this section are not intended to replace the financial statements and related notes included elsewhere in this prospectus. Our historical results are not necessarily indicative of our future results, and our interim results for the nine months ended
September 30, 2017
are not necessarily indicative of results to be expected for the full year ending December 31, 2017 or any other period.
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Year Ended December 31,
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Nine Months Ended September 30,
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2015
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2016
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2016
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2017
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(in thousands, except share and per share numbers)
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Statements of Operations Data:
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Collaboration and license revenue
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$
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—
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$
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674
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$
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224
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$
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1,807
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Operating expenses:
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Research and development
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2,921
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11,255
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7,178
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18,461
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General and administrative
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1,687
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3,751
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2,453
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3,462
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Total operating expenses
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4,608
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15,006
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9,631
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21,923
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Loss from operations
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(4,608
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(14,332
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)
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(9,407
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(20,116
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Interest income and other expense, net
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—
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264
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176
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316
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Net loss attributable to common stockholders
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$
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(4,608
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$
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(14,068
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)
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$
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(9,231
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)
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$
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(19,800
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)
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Net loss attributable to common stockholder per share, basic and diluted
(1)
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$
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(0.36
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)
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$
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(1.05
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$
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(0.69
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$
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(1.44
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)
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Weighted‑average number of common shares used to compute basic and diluted net loss per share
(1)
|
12,772,388
|
|
|
13,429,823
|
|
|
13,370,809
|
|
|
13,720,985
|
|
Pro forma net loss per share attributable to common stockholders, basic and diluted (unaudited)
(2)
|
|
|
$
|
(0.51
|
)
|
|
|
|
$
|
(0.64
|
)
|
Pro forma weighted‑average number of common shares outstanding, basic and diluted (unaudited)
(2)
|
|
|
27,550,706
|
|
|
|
|
31,108,477
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
See notes to our financial statements included elsewhere in this prospectus for an explanation of the calculations of our net loss per share, basic and diluted and the weighted‑average number of shares used in the computation of the per share amounts.
|
|
|
(2)
|
The pro forma net loss per share attributable to common stockholders, basic and diluted, and the pro forma weighted‑average number of common shares outstanding, basic and diluted, data is computed using the weighted‑average number of shares of common stock outstanding, after giving effect to the conversion of all the outstanding shares of our convertible preferred stock into an aggregate of 25,975,346 shares of our common stock, which will occur immediately prior to the completion of this offering, as if such transaction had occurred on
|
September 30, 2017
. The pro forma net loss per share of common stock, basic and diluted, and the pro forma weighted‑average number of common shares outstanding, basic and diluted, does not give effect to the issuance of shares from the proposed initial public offering nor do they give effect to potential dilutive securities where the impact would be anti‑dilutive. See Note 9 to our audited financial statements included elsewhere in this prospectus.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2017
|
|
|
Actual
|
|
Pro Forma
(1)
|
|
Pro Forma As Adjusted
(2)
|
|
|
(in thousands)
|
Balance Sheet Data:
|
|
|
|
|
|
|
Cash, cash equivalents and investments
|
|
$
|
73,547
|
|
|
$
|
73,547
|
|
|
|
Working capital
|
|
68,560
|
|
|
68,560
|
|
|
|
Total assets
|
|
75,800
|
|
|
75,800
|
|
|
|
Convertible preferred stock
|
|
109,330
|
|
|
—
|
|
|
|
Accumulated deficit
|
|
(49,915
|
)
|
|
(49,915
|
)
|
|
|
Total stockholders’ (deficit) equity
|
|
(47,961
|
)
|
|
61,369
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Reflects the conversion of all the outstanding shares of our convertible preferred stock as of
September 30, 2017
into an aggregate of 25,975,346 shares of our common stock, which will occur immediately prior to the completion of this offering.
|
|
|
(2)
|
Reflects the pro forma adjustment described in footnote (1) and the sale and issuance of shares of our common stock by us in this offering, at the assumed initial public offering price of $ per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. Each $1.00 increase (decrease) in the assumed initial public offering price of $ per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, would increase (decrease) our cash, cash equivalents and investments, working capital, total assets and total stockholders’ (deficit) equity by approximately $ million, assuming that the number of shares of our common stock offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions payable by us. Each increase (decrease) of 1,000,000 shares in the number of shares offered by us would increase (decrease) the amount of our cash, cash equivalents and investments, working capital, total assets and total stockholders’ (deficit) equity by approximately $ million, assuming an initial public offering price of $ per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us
.
|
RISK FACTORS
Investing in our common stock involves a high degree of risk. You should carefully consider the risks described below, as well as the other information in this prospectus, including our financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding whether to invest in our common stock. The occurrence of any of the events or developments described below could have a material adverse effect on our business, results of operations, financial condition, prospects and stock price. In such an event, the market price of our common stock could decline, and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business operations.
Risks Related to Our Financial Position and Capital Needs
We have a limited operating history, have incurred significant losses since our inception, and anticipate that we will continue to incur losses for the foreseeable future. We have only one product candidate in clinical trials and no commercial sales, which, together with our limited operating history, makes it difficult to assess our future viability.
We are a late‑stage biopharmaceutical company with a limited operating history. Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. To date, we have focused principally on developing serlopitant, which is our only product in development. We are not profitable and have incurred losses in each year since our inception in 2011. We have only a limited operating history upon which you can evaluate our business and prospects. In addition, we have limited experience and have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the biopharmaceutical industry. We have not generated any revenue from product sales to date. We continue to incur significant research and development and other expenses related to our ongoing operations. Our net loss for the years ended December 31, 2015 and 2016 was approximately $4.6 million and $14.1 million, respectively, and
$9.2 million
and
$19.8 million
for the nine months ended
September 30, 2016
and
2017
, respectively. As of
September 30, 2017
, we had an accumulated deficit of
$49.9 million
. We expect to continue to incur losses for the foreseeable future, and we anticipate these losses will increase as we continue our development, seek regulatory approval of, and, if approved, begin to commercialize serlopitant. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity and working capital.
We will require substantial additional financing, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development, other operations or commercialization efforts.
We have devoted substantially all of our financial resources and efforts to the development of serlopitant as a once‑daily, oral tablet treatment of pruritus associated with underlying dermatologic conditions such as atopic dermatitis, psoriasis and prurigo nodularis, and for the treatment of chronic refractory cough. As of
September 30, 2017
, we had capital resources consisting of cash, cash equivalents and investments of
$73.5 million
.
We expect to incur substantial expenditures in the foreseeable future as we advance serlopitant through clinical development, the regulatory approval process and, if approved, commercial launch activities. Specifically, in the near term, we expect to incur substantial expenses relating to our ongoing Phase 2 and planned Phase 3 clinical trials, the development and validation of our commercial manufacturing process for serlopitant, and other development activities including potentially commencing Phase 3 clinical trials for pruritus associated with atopic dermatitis and psoriasis, and for refractory chronic cough. In addition, we expect to pay a $3.0 million milestone payment to Merck upon the initiation of our Phase 3 clinical trials for pruritus associated with prurigo nodularis. Furthermore, upon the closing of this offering, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses that we did not incur as a private company.
We also expect to incur expenses related to the recruitment and retention of personnel, working capital and other general corporate purposes. We may incur additional expenses in connection with expanding our pipeline, including by pursuing additional indications for serlopitant or the in‑license or acquisition of additional drug candidates or commercial products.
We believe that our existing cash, cash equivalents and investments, will be sufficient to fund our planned operations through at least the next 12 months. However, because the outcome of any clinical trial or regulatory approval process is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development, regulatory approval process and commercialization of serlopitant. Our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity, debt financings or other sources, such as strategic collaborations. Such financing may result in dilution to stockholders, imposition of debt covenants and repayment obligations, or other restrictions that may affect our business. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.
Our future funding requirements will depend on many factors, including, but not limited to:
|
|
▪
|
the time and cost necessary to complete our ongoing Phase 2 clinical trials for pruritus associated with atopic dermatitis and psoriasis and for refractory chronic cough, our planned Phase 3 clinical trials for pruritus associated with prurigo nodularis as well as any additional current and planned clinical trials of serlopitant;
|
|
|
▪
|
the number, size and type of any additional clinical trials or studies we may choose to initiate or that we may be required to complete prior to obtaining regulatory approval of serlopitant;
|
|
|
▪
|
the timing of, and costs involved in, seeking and obtaining approvals from the FDA and comparable foreign regulatory authorities, including the potential by the FDA or comparable regulatory authorities to require that we perform more studies than those that we current expect, and the costs of post‑marketing studies that could be required by regulatory authorities;
|
|
|
▪
|
our ability to receive payments under our collaboration with Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd, together referred to as JT Torii, and the timing of receipt of any such payments;
|
|
|
▪
|
the timing of the milestone payments we must make to Merck;
|
|
|
▪
|
the costs of preparing to manufacture serlopitant on a commercial scale;
|
|
|
▪
|
our ability to successfully commercialize serlopitant;
|
|
|
▪
|
the manufacturing, selling and marketing costs associated with serlopitant, including the cost and timing of forming and expanding our sales organization and marketing capabilities;
|
|
|
▪
|
the amount of sales and other revenues from serlopitant, including the sales price and the availability of adequate third‑party reimbursement;
|
|
|
▪
|
the degree and rate of market acceptance of any products launched by us or our partners;
|
|
|
▪
|
the cash requirements of any future acquisitions or discovery of product candidates;
|
|
|
▪
|
the progress, timing, scope and costs of our non‑clinical studies and clinical trials, including the ability to enroll patients in a timely manner in potential future clinical trials;
|
|
|
▪
|
the time and cost necessary to respond to technological and market developments;
|
|
|
▪
|
the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
|
|
|
▪
|
our need and ability to hire additional personnel;
|
|
|
▪
|
our ability to enter into additional collaboration, licensing, commercialization or other arrangements and the terms and timing of such arrangements; and
|
|
|
▪
|
the emergence of competing technologies or other adverse market developments.
|
Additional funds may not be available when we need them, on terms that are acceptable to us, or at all. If adequate funds are not available to us on a timely basis, we may be required to delay, limit, reduce or terminate:
|
|
▪
|
clinical trials or other development activities for serlopitant or any future product candidate; or
|
|
|
▪
|
our establishment of sales and marketing capabilities or other activities that may be necessary to commercialize serlopitant or any future product candidate.
|
Risks Related to Our Business
We are substantially dependent on the success of our sole product candidate, serlopitant.
To date, we have invested substantially all of our efforts and financial resources in the development of serlopitant, which is currently our sole product candidate in development. Our prospects, including our ability to finance our operations and generate revenue from product sales, will currently depend entirely on the successful development and commercialization of serlopitant. The clinical and commercial success of serlopitant will depend on a number of factors, including the following:
|
|
▪
|
the timely completion of and results from our three ongoing Phase 2 clinical trials of serlopitant for the treatment of pruritus associated with atopic dermatitis and psoriasis, and for refractory chronic cough;
|
|
|
▪
|
the initiation of and results from our planned Phase 3 clinical trials of serlopitant for the treatment of pruritus associated with prurigo nodularis;
|
|
|
▪
|
the initiation of and results from any Phase 3 clinical trials, if conducted, in pruritus associated with atopic dermatitis, pruritus associated with psoriasis, or refractory chronic cough;
|
|
|
▪
|
whether the FDA disagrees with the number, design, size, conduct, or implementation of our planned and future clinical trials;
|
|
|
▪
|
our ability to demonstrate serlopitant’s safety and efficacy to treat pruritus associated with atopic dermatitis, with psoriasis or with prurigo nodularis or to treat refractory chronic cough to the satisfaction of the FDA or foreign regulatory authorities;
|
|
|
▪
|
the timely completion and results of any additional clinical trials and non‑clinical studies conducted to support the filing for regulatory approvals of serlopitant;
|
|
|
▪
|
whether we are required by the FDA or foreign regulatory authorities to conduct additional clinical trials prior to approval to market serlopitant for any indication;
|
|
|
▪
|
our ability to execute on our clinical trial plans and monitor the conduct of the studies by the contract research organizations, or CROs, and medical institutions;
|
|
|
▪
|
the prevalence, frequency and severity of adverse side effects of serlopitant;
|
|
|
▪
|
the timely receipt of necessary marketing approvals from the FDA and foreign regulatory authorities to treat pruritus associated with atopic dermatitis, psoriasis or prurigo nodularis, or to treat refractory chronic cough;
|
|
|
▪
|
our ability to raise sufficient additional capital to fund development, manufacturing and commercialization activities for serlopitant;
|
|
|
▪
|
our ability to successfully commercialize serlopitant, if approved for marketing and sale by the FDA or foreign regulatory authorities, whether alone or in collaboration with others;
|
|
|
▪
|
the ability of our third‑party manufacturers to manufacture quantities of serlopitant using commercially sufficient processes at a scale sufficient to meet anticipated demand and at a cost appropriate for our commercialization;
|
|
|
▪
|
the ability of our third‑party manufacturers to comply with current good manufacturing practices, or cGMP;
|
|
|
▪
|
achieving and maintaining compliance with all regulatory requirements applicable to serlopitant;
|
|
|
▪
|
our success in educating physicians and patients about the benefits, administration and use of serlopitant;
|
|
|
▪
|
the willingness of physicians and patients to utilize or adopt serlopitant;
|
|
|
▪
|
the availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing treatments;
|
|
|
▪
|
our ability to obtain and sustain an adequate level of reimbursement for serlopitant by third‑party payors;
|
|
|
▪
|
the effectiveness of our own, our current collaborator’s, or any future strategic collaborators’ marketing, sales and distribution strategy and operations;
|
|
|
▪
|
our ability to enforce our intellectual property rights in and to serlopitant;
|
|
|
▪
|
our ability to avoid third‑party patent interference or patent infringement claims;
|
|
|
▪
|
a continued acceptable safety profile of serlopitant following approval; and
|
|
|
▪
|
emerging safety signals from other drugs generally perceived to be in the same drug class as serlopitant, including NK
1
-R antagonists.
|
Many of these factors are beyond our control. Accordingly, we cannot assure you that we will ever be able to generate revenue through the sale of serlopitant. If we are not successful in commercializing serlopitant, or are significantly delayed in doing so, our business will be materially harmed.
Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of serlopitant.
To gain approval to market a drug product, we must provide the FDA and foreign regulatory authorities with non‑clinical, clinical, and chemistry, manufacturing, and controls, or CMC, data that adequately demonstrates the safety and efficacy of the product for the intended indication applied for in the NDA or other respective regulatory filing. Drug development is a long, expensive and uncertain process, and delay or failure can occur at any stage of any of our clinical trials. Further, although members of our management team have conducted clinical trials and obtained marketing approvals for product candidates in the past while employed at other companies, we as a company have not done so. As a result, such activities may require more time and cost more than we anticipate.
Our business currently depends entirely on the successful development, regulatory approval and commercialization of serlopitant following completion of all required non‑clinical and clinical trials, and generation of adequate CMC data. We are in discussions with the FDA to finalize our Phase 3 clinical protocols for trials of serlopitant for the treatment of pruritus associated with prurigo nodularis, which we plan to initiate in the first half of 2018 under our investigational new drug application, or IND, for serlopitant for pruritus indications. We also met with the FDA prior to the start of our Phase 2 clinical trial in pruritus associated with atopic dermatitis to discuss clinical trial design elements, primary endpoint measures, statistical considerations and other key elements of the development program.
We anticipate that development of serlopitant for use in pediatric patients will be a required element of our development program for some of our target indications. We are developing a pediatric plan for review with regulatory authorities in Europe and the United States.
In
September 2017, the FDA authorized us to proceed with our Phase 2 clinical trial in refractory chronic cough under a separate IND for this indication.
We enrolled the first patients in the trial in October 2017 and we expect data from this trial to be available in late 2018 or early 2019.
We may experience numerous unforeseen events during or as a result of our non‑clinical studies and clinical trials that could delay or prevent our ability to receive marketing approval or commercialize serlopitant, including:
|
|
▪
|
regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
|
|
|
▪
|
we may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites or CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
|
|
|
▪
|
the number of subjects required for clinical trials of serlopitant may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials or fail to return for post‑treatment follow‑up at a higher rate than we anticipate;
|
|
|
▪
|
serlopitant may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or institutional review boards to suspend or terminate the trials;
|
|
|
▪
|
our third‑party contractors and clinical trial sites may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;
|
|
|
▪
|
regulators or institutional review boards may require that we or our investigators suspend or terminate clinical trials for various reasons, including noncompliance with regulatory requirements or a finding that the trial subjects are being exposed to unacceptable risks; and
|
|
|
▪
|
the supply or quality of serlopitant or other materials necessary to conduct clinical trials of our drug candidates may be insufficient or inadequate.
|
We could also encounter delays if a clinical trial is suspended or terminated by us, by the institutional review boards of the institutions in which such trials are being conducted, by the data safety monitoring board for such trial or by the FDA or other regulatory authorities. Authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using serlopitant, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. If we experience delays in the completion of, or termination of, any clinical trial of serlopitant, the commercial prospects of serlopitant will be harmed, and our ability to generate product revenues from serlopitant will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slow down our development of serlopitant and its approval process and jeopardize our ability to commence product sales and generate revenues. Any of these occurrences may harm our business, financial condition and prospects significantly. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of serlopitant. If we are required to conduct additional clinical trials or other testing of serlopitant beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of serlopitant candidates or other testing, if the results of these trials or tests are not favorable or if there are safety concerns, we may:
|
|
▪
|
be delayed in obtaining marketing approval for serlopitant;
|
|
|
▪
|
not obtain marketing approval at all;
|
|
|
▪
|
obtain approval for indications or patient populations that are not as broad as intended or desired;
|
|
|
▪
|
obtain approval with labeling that includes significant use or distribution restrictions or safety warnings;
|
|
|
▪
|
be subject to additional post‑marketing testing requirements; or
|
|
|
▪
|
have the drug removed from the market after obtaining marketing approval.
|
Success in non-clinical testing and early clinical trials does not ensure that later clinical trials will be successful, and we cannot assure you that any of our current Phase 2 clinical trials, planned Phase 3 clinical trials or any other clinical trials that we may conduct will demonstrate consistent or adequate efficacy and safety to obtain regulatory approval to market serlopitant in any indication.
The primary efficacy analysis in our completed Phase 2 clinical trials of pruritus was a statistically significant change in itch VAS from baseline compared to placebo measured at week six or eight. Based upon our interactions with the FDA, we will use a different efficacy analysis for our planned Phase 3 clinical trials, a 4‑point responder rate on the worst‑itch numeric rating scale, or WI‑NRS. We analyzed 4‑point responders in our Phase 2 clinical trials after the completion of the study. The analyses of the percentage of patients with at least a 40 mm response on the visual analogue scale, or VAS, or a 4‑point response on WI‑NRS, were not pre‑specified in our initial completed Phase 2 clinical trials’ statistical analysis plans, and are thus considered post‑hoc analyses. For these and other reasons, our Phase 2 clinical trials may not predict serlopitant’s ability to demonstrate a statistically significant reduction in pruritus using this measure in Phase 3 clinical trials.
It is also possible that the FDA or other regulatory agencies may require additional endpoints that are not currently included in our serlopitant clinical trials.
In our completed Phase 2 clinical trial of serlopitant for pruritus associated with prurigo nodularis,
concomitant medications for treatment of pruritus other than loratadine or cetirizine were excluded
. In our planned Phase 3 clinical trials for pruritus associated with prurigo nodularis, patients will be permitted to take certain additional medications that were not permitted in the Phase 2 clinical trial. The efficacy or safety of serlopitant when used with other agents in the Phase 3 clinical trials may differ from the Phase 2 clinical trial as a result of these additional medications. Phase 3 clinical trials with larger numbers of patients or longer durations of therapy may also reveal safety concerns that were not identified in earlier smaller or shorter trials.
Other companies in the biopharmaceutical industry have frequently suffered significant setbacks in later clinical trials, even after achieving promising results in earlier non‑clinical studies or clinical trials.
Use of patient-reported outcome assessments, or PROs, in our clinical trials may delay or impair the development of serlopitant and/or adversely impact our clinical trials.
Due to the difficulty of objectively measuring pruritus,
the assessment of pruritus in clinical trials typically involves the use of PROs
.
For example, our clinical trials evaluating serlopitant in pruritus indications have used both the VAS and NRS scales, which require patients to evaluate their pruritus according to a numerical scale with the lowest number representing no itch and the highest number representing the worst itch imaginable. PROs have an important role in the development and regulatory approval of treatments for pruritus such as serlopitant. PROs involve patients’ subjective assessments of efficacy, and this subjectivity can increase the uncertainty of clinical trial outcomes assessing pruritus. Such assessments can be influenced by factors outside of the patient’s control, and can vary widely from day to day for a particular patient, and from patient to patient and site to site within a clinical trial.
The variability of PRO measures for itch and the high placebo response rates could adversely impact our serlopitant development program. In addition, PROs for itch assessment have historically been observed to have high placebo group response rates, including in some of our trials. For example, in our Phase 2 clinical trial in patients with chronic pruritus, patients receiving placebo reported a greater than 25% decrease from baseline in itch VAS scores. Variability in the placebo group response has adversely impacted clinical results of other therapies being tested for itch reduction, and could adversely impact our clinical trial results. The variability of a PRO measure may be greater than some measures used for clinical trial assessments, and that variability can complicate clinical trial design, adversely impact the ability of a study to show a statistically significant improvement, and generally adversely impact a clinical development program by introducing additional uncertainties.
It is also possible that the FDA may require changes in the PRO we are currently using or may indicate that the PRO we are using is not acceptable for demonstrating efficacy in pruritus reduction, potentially delaying clinical development of serlopitant, increasing our costs and making additional clinical trials necessary.
If we experience delays or difficulties in the enrollment of subjects in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
Successful and timely completion of clinical trials will require that we enroll a sufficient number of subjects. Patient enrollment, a significant factor in the timing of clinical trials, is affected by many factors including the size and nature of the patient population and the ability of clinical sites to successfully recruit subjects to participate in clinical trials. Trials may be subject to delays as a result of patient enrollment taking longer than anticipated or patient withdrawal. For example, we previously initiated a clinical trial of serlopitant to treat pruritus following burn injury, but discontinued the trial due to lack of timely enrollment. Enrollment can also be affected by seasonality and other factors. We may not be able to initiate or continue clinical trials for our drug candidates if we are unable to locate and enroll a sufficient number of eligible subjects to participate in these trials as required by the FDA or similar regulatory authorities outside the United States. In particular, among our target indications, prurigo nodularis is a relatively rare condition, and we are in discussions regarding the specific population of prurigo nodularis patients that we may enroll in our Phase 3 clinical trials. It is possible that the specific requirements by the FDA for our patients to be included in these trials may make the trials more difficult to conduct, or may significantly extend the time required for enrollment of these trials.
We cannot predict how successful we will be at enrolling subjects in future clinical trials. Subject enrollment is affected by other factors including:
|
|
▪
|
the eligibility criteria for the trial in question;
|
|
|
▪
|
the prevalence and incidence of the conditions being studied in the clinical trials;
|
|
|
▪
|
the perceived risks and benefits of serlopitant;
|
|
|
▪
|
clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new drugs or therapeutic biologics that may be approved for the indications we are investigating;
|
|
|
▪
|
the efforts to facilitate timely enrollment in clinical trials;
|
|
|
▪
|
competition for patients from other clinical trials;
|
|
|
▪
|
the success of any advertising campaigns conducted to recruit subjects to enroll in clinical trials;
|
|
|
▪
|
the willingness of potential clinical trial subjects to provide informed consent to participate in the trial;
|
|
|
▪
|
the patient referral practices of physicians;
|
|
|
▪
|
the ability to monitor subjects adequately during and after treatment; and
|
|
|
▪
|
the proximity and availability of clinical trial sites for prospective subjects.
|
Our inability to enroll a sufficient number of subjects for clinical trials would result in significant delays and could require us to abandon one or more clinical trials altogether. Enrollment delays in these clinical trials may result in increased development costs for our drug candidates or delays in regulatory filings and progression, which would cause the value of our company to decline and limit our ability to obtain additional financing. Furthermore, we rely on and expect to continue to rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials and we will have limited influence over their performance.
We rely on third parties to conduct our non-clinical studies and our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for or commercialize serlopitant or any future product candidates.
We do not have the ability to independently conduct non‑clinical studies and clinical trials. We rely on medical institutions, clinical investigators, contract laboratories, collaborative partners and other third parties, such as CROs, to conduct non‑clinical studies and clinical trials on our drug candidates. The third parties with whom we contract for execution of our non‑clinical studies and clinical trials play a significant role in the conduct of these studies and trials and the subsequent collection and analysis of data. However, these third parties are not our employees, and except for contractual duties and obligations, we have limited ability to control the amount or timing of resources that they devote to our programs.
Although we rely on third parties to conduct our non‑clinical studies and clinical trials, we remain responsible for ensuring that each of our non‑clinical studies and clinical trials is conducted in accordance with its investigational plan and protocol. Moreover, the FDA and foreign regulatory authorities require us to comply with regulations and standards, including some regulations commonly referred to as good clinical practices, or GCPs, for conducting, monitoring, recording and reporting the results of clinical trials to ensure that the data and results are scientifically credible and accurate, and that the trial subjects are adequately informed of the potential risks of participating in clinical trials. In the past, we have experienced an issue of non‑compliance with dosing among several patients at one of the clinical sites in one of our trials. We determined through analysis of the results of the trial and a comprehensive third‑party audit that this single‑site issue did not affect the results of that clinical trial.
In addition, the execution of non‑clinical studies and clinical trials, and the subsequent compilation and analysis of the data produced, requires coordination among various parties. In order for these functions to be carried out effectively and efficiently, it is imperative that these parties communicate and coordinate with one another. Moreover, these third parties may also have relationships with other commercial entities, some of which may compete with us. Under certain circumstances, these third parties may terminate their agreements with us upon as little as 30 days’ prior written notice. Some of these agreements may also be terminated by such third parties under certain other circumstances, including our insolvency. If the third parties conducting our clinical trials do not perform their contractual duties or obligations, experience work stoppages, do not meet expected deadlines, terminate their agreements with us or 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 trial protocols or GCPs, or for any other reason, we may need to enter into new arrangements with alternative third parties, which could be difficult, costly or impossible, and our clinical trials may be extended, delayed or terminated or may need to be repeated. If any of the foregoing were to occur, we may not be able to obtain regulatory approval for or commercialize the product candidate being tested in such trials.
We rely completely on third-party suppliers to manufacture serlopitant, and we intend to continue to rely on third parties to produce non-clinical, clinical and commercial supplies of serlopitant.
We currently contract with one third party for the manufacture of serlopitant drug substance and another third party for serlopitant drug products for clinical trials, and we do not plan to acquire the infrastructure or internal capability to produce our non‑clinical, clinical and commercial supplies of serlopitant. We anticipate that these third parties will have capacity to support commercial scale, but we do not have any formal agreements at this time to cover commercial production of serlopitant. We may engage additional contract manufacturers for production of supplies of precursor materials used to synthesize serlopitant drug substance and to assist in the manufacture of the drug product.
The FDA and other comparable foreign regulatory agencies must, pursuant to inspections that will be conducted after we submit our NDA or relevant foreign regulatory submission, approve our contract manufactures to manufacture serlopitant or any future product candidates. We do not directly control the manufacturing of serlopitant, and we are completely dependent on our contract manufacturers for compliance with the cGMP requirements for manufacture of both active drug substances and finished drug products. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or foreign regulatory agencies, we will not be able to secure and/or maintain regulatory approval for their manufacturing facilities. In addition, we have no direct control over the ability of our
contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. Furthermore, all of our contract manufacturers are engaged with other companies to supply or manufacture materials or products for such companies, which exposes our manufacturers to regulatory risks for the production of such materials and products. As a result, failure to meet the regulatory requirements for the production of those materials and products may generally affect the regulatory clearance of our contract manufacturers’ facilities. If the FDA or a comparable foreign regulatory agency does not approve these facilities for the manufacture of our product candidates or if it withdraws its approval in the future, we may need to find alternative manufacturing facilities, which would negatively impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved.
We and our third‑party suppliers continue to refine and improve the manufacturing process, certain aspects of which are complex and unique, and we may encounter difficulties with new or existing processes, particularly as we seek to significantly increase our capacity to commercialize serlopitant. Our reliance on contract manufacturers also exposes us to the possibility that they, or third parties with access to their facilities, will have access to and may appropriate our trade secrets or other proprietary information.
As drug candidates are developed through non‑clinical studies to late‑stage clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods, methods of making drug formulations, and drug formulations, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause our drug candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the altered materials. Such changes may also require additional testing, FDA notification or FDA approval. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our drug candidates and jeopardize our ability to commence sales and generate revenue.
Key manufacturing steps and materials used in our drug substance and in our drug product are provided by limited numbers of suppliers, and supply shortages or loss of these suppliers could result in interruptions in supply or increased costs.
Certain manufacturing steps and materials used in our serlopitant drug substance and in our serlopitant drug product, are currently performed by or purchased from a single outside source. The reliance on a sole or limited number of suppliers could result in:
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delays associated with redesigning or revalidating a drug product or manufacturing process due to a failure to obtain a single source material from an existing validated supplier;
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an inability to obtain an adequate supply of required materials; and
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reduced control over pricing, quality and delivery time.
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We have supply agreements in place for certain starting materials of our drug substance and drug products, but do not have in place long term supply agreements. Therefore, the supply of a particular starting material could be terminated at any time without penalty to the supplier. In addition, we may not be able to procure required starting materials from third‑party suppliers at a quantity, quality and cost acceptable to us. Any interruption in the supply of single source starting material could cause us to seek alternative sources of supply or manufacture these materials internally. Furthermore, in some cases, we are relying on our third‑party collaborators to procure supply of necessary materials. If the supply of any materials for our drug product is interrupted, materials from alternative suppliers may not be available in sufficient volumes or at acceptable quality levels, or at acceptable cost within required timeframes, if at all, to meet our needs or those of our third‑party collaborators. This could delay our ability to complete clinical trials and obtain approval for commercialization and marketing of our product candidates, causing us to incur additional costs, delay new product introductions, or lose sales, and could harm our reputation.
Investigator sponsored trials of serlopitant may produce results and safety signals that are beyond our control and impact our development and commercialization of serlopitant.
Serlopitant is being evaluated in a 14‑patient exploratory investigator sponsored study at Stanford University as a potential treatment to reduce pruritus associated with epidermolysis bullosa, a rare primarily pediatric skin condition. If serious adverse events or other undesirable side effects, or unexpected characteristics of serlopitant, are observed in this trial, it may adversely affect or delay our clinical development of serlopitant, and the occurrence of these events would have a material adverse effect on our business.
We may in the future choose to permit other investigators to evaluate serlopitant or future product candidates in other investigator sponsored studies which could adversely impact our development programs.
We currently have no sales organization. If we are unable to establish sales capabilities on our own or through third parties, we may not be able to market and sell serlopitant, if approved, or any future product candidates or generate product revenue.
We currently do not have a sales organization. In order to commercialize serlopitant, if approved, we must build our marketing, sales, distribution, managerial and other non‑technical capabilities or make arrangements with third parties to perform these services, and we may not be successful in doing so. If serlopitant receives regulatory approval, we expect to establish a specialty sales organization with technical expertise and supporting distribution capabilities to commercialize it to dermatologists and possibly also to pediatricians and primary care physicians or to pulmonologists and allergists, which will be expensive and time consuming. We have no prior experience in the marketing, sale and distribution of pharmaceutical products and there are significant risks involved in building and managing a sales organization, including our ability to hire, retain and incentivize qualified individuals, provide adequate training to sales and marketing personnel, gain access to physicians or persuade adequate numbers of physicians to prescribe serlopitant, if approved, or any future drugs, and effectively manage a geographically dispersed sales and marketing team. Our efforts to commercialize serlopitant on our own may also be impacted by the lack of complementary drugs to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines, and any unforeseen costs and expenses associated with creating an independent sales and marketing organization. Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely impact the commercialization of these products.
We may choose to collaborate with third parties that have direct sales forces and established distribution systems, either to augment our own sales organization and distribution systems or in lieu of our own sales organization and distribution systems. If we are unable to enter into such arrangements on acceptable terms or at all, we may not be able to successfully commercialize serlopitant. If we are not successful in commercializing serlopitant or any future product candidates, either on our own or through collaborations with one or more third parties, our future product revenue will suffer and we would incur significant additional losses.
If we breach our license agreement for serlopitant, we could lose the ability to continue the development and commercialization of our product. Merck also retains rights to serlopitant in specific fields.
In December 2012, we entered into a license agreement with Merck to obtain exclusive worldwide rights to research, develop, manufacture, market and sell serlopitant, other than for the treatment or prevention of nausea and vomiting. This agreement requires us to use commercially reasonable efforts to develop and commercialize serlopitant, make timely milestone payments, provide certain information regarding our activities with respect to such products, maintain the confidentiality of information we receive from Merck and indemnify Merck with respect to our development and commercialization activities under the terms of the agreement.
If we fail to meet these obligations, Merck has the right to terminate our exclusive license and upon the effective date of such termination, has the right to re‑obtain the licensed technology as well as aspects of any intellectual property controlled by us and developed during the period the agreement was in force that relate to the licensed technology. This means that Merck could effectively take control of the development and commercialization of serlopitant after an uncured, material breach of our license agreement by us. This would also be the case if we voluntarily terminate the agreement. While we would expect to exercise all rights and remedies available to us, including seeking to cure any breach by us, and otherwise seek to preserve our rights under the patents licensed to us, we may not be able to do so in a timely manner, at an acceptable cost or at all. Any uncured, material
breach under the license could result in our loss of exclusive rights and may lead to a complete termination of our product development and any commercialization efforts for serlopitant.
Merck could also develop serlopitant for treatment of nausea or vomiting, or license these rights to a third party. Development of serlopitant in other fields could increase the possibility of identification of adverse safety results that impact our development of serlopitant for pruritus associated with dermatologic conditions and refractory chronic cough. In addition, if approved, commercialization of serlopitant in other fields could result in an increased threat of off‑label use to compete with the sale of serlopitant to treat these indications.
We depend on our collaborative relationship with JT Torii for the development and commercialization of serlopitant in Japan. The collaboration relationship with JT Torii or any other collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize serlopitant.
We have a license and collaboration agreement with JT Torii under which we have granted JT Torii the rights to develop and commercialize products containing serlopitant in Japan in exchange for an up‑front payment and potential future development, regulatory and commercial milestone payments and royalties based on future sales of licensed product in Japan.
We may seek additional collaboration arrangements with pharmaceutical or biotechnology companies for the development or commercialization of serlopitant. We may enter into these arrangements on a selective basis depending on the merits of retaining commercialization rights ourselves compared to entering into selective collaboration arrangements with leading pharmaceutical or biotechnology companies for serlopitant internationally and possibly also in the United States.
Our ability to generate revenues from our collaboration arrangement with JT Torii will depend on JT Torii’s ability to successfully perform the functions assigned to it in the arrangement, and accordingly, any failure by JT Torii to develop and commercialize serlopitant could adversely affect our cash flows. Similarly, the success of future collaboration arrangements will depend heavily on the efforts and activities of our collaborators. Collaborators generally have significant discretion in determining the efforts and resources that they will apply to these collaborations.
When entering collaboration arrangements, such as that with JT Torii, we are subject to a number of risks, including:
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collaborators may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial or abandon products, repeat or conduct new clinical trials, require a new formulation of products for clinical testing, may decide not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to their acquisition of competitive products or their internal development of competitive products, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities;
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any safety issues or adverse side effects that result from trials conducted by a collaborator will adversely impact our ability to obtain regulatory approval for serlopitant or any other product we may develop in the future;
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any failure by a collaborator to demonstrate efficacy of serlopitant, or any potential future product candidate, in its clinical trials could decrease the perceived likelihood of success for our clinical trials;
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disagreements between parties to a collaboration arrangement regarding clinical development and commercialization matters may lead to delays in the development process or commercializing the applicable product candidate and, in some cases, termination of the collaboration arrangement;
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collaboration arrangements are complex and time consuming to negotiate, document and implement, and we may not be successful in our efforts to establish and implement collaborations or other alternative arrangements should we so chose to enter into such arrangements;
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collaborations with pharmaceutical or biotechnology companies and other third parties often are terminated or allowed to expire by the other party and any such termination or expiration would adversely affect us financially and could harm our business reputation;
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collaboration agreements may be terminated and, if terminated, may result in delays or the need for a new collaborator or additional capital to pursue further development or commercialization of serlopitant or other future product candidates in certain markets;
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collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates;
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terms of any collaborations or other arrangements that we may establish may not be favorable to us;
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we could grant exclusive rights to our collaborators that would prevent us from collaborating with others;
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we will face, to the extent that we decide to enter into collaboration agreements, significant competition in seeking appropriate collaborators;
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collaborations with pharmaceutical or biotechnology companies and other third parties often are terminated or allowed to expire by the other party and any such termination or expiration could adversely affect us financially and could harm our business reputation;
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collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;
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collaborators may own or co‑own intellectual property covering products that results from our collaborating with them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual property;
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disputes may arise with respect to the ownership of any intellectual property developed pursuant to our collaborations;
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collaborators’ sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings;
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adverse regulatory determinations or other legal action may interfere with the ability of a collaborator to conduct clinical trials or other development activity;
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one or more collaborator may be subject to regulatory or legal action resulting from the failure to meet healthcare industry compliance requirements in the conduct of clinical trials or the promotion and sale of products; and
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collaboration arrangements could be adversely impacted by changes in collaborators’ key management personnel and other personnel that are administering collaboration agreements.
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Additionally, JT Torii will be conducting clinical trials of serlopitant under our collaboration agreement.
If serious adverse events or other undesirable side effects, or unexpected characteristics of serlopitant, are observed in these trials, it may adversely affect or delay our clinical development of serlopitant, and the occurrence of these events would have a material adverse effect on our business.
We face substantial competition, which may result in others discovering, developing or commercializing drugs before or more successfully than we do.
The biopharmaceutical industry is intensely competitive and is subject to rapid and significant change. We face competition from other pharmaceutical and biotechnology companies, research institutions, and other organizations, particularly companies that develop and market pharmaceutical products for dermatologic and respiratory conditions. Our commercial potential may be limited by other companies that develop and sell other
novel products that are effective for our target indications, or that may be more effective, safer or cost less than serlopitant.
Although there are currently no approved drugs specifically indicated for pruritus associated with atopic dermatitis, psoriasis or prurigo nodularis, either in the United States or in Europe, we may face competition from
those companies that are developing drugs specifically to treat pruritus associated with a variety of underlying dermatologic or systemic conditions, companies that are developing drugs specifically to treat chronic cough, companies that are developing and marketing other NK
1
‑R antagonists for pruritus or other conditions, that, when approved, could be used off‑label to treat pruritus or cough, and companies that currently market or are developing treatments intended directly to treat the underlying disease condition in atopic dermatitis, psoriasis, or prurigo nodularis that have also been shown to have anti‑pruritic effects.
We are aware of other companies targeting pruritus or chronic cough as the primary outcome measure in United States clinical studies of drugs. There are multiple companies developing products at varying stages of development specifically intended to treat pruritus including: Vanda Pharmaceuticals, Trevi Therapeutics, Galderma, Sienna Biopharmaceuticals, Tioga and Cara Therapeutics. In addition, Merck and Nerre Therapeutics are developing therapeutic treatments for chronic cough. Of these companies, Vanda and Nerre are developing NK
1
‑R antagonists for indications t
hat may compete directly with serlopitant.
Other companies, including Tesaro and Merck, are also marketing or developing NK
1
‑R antagonists for other indications and could compete with serlopitant.
Even if serlopitant receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
If serlopitant receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third‑party payors and others in the medical community. If serlopitant does not achieve an adequate level of acceptance, we may not generate significant revenue and we may not become profitable. The degree of market acceptance of serlopitant, if approved for commercial sale, will depend on a number of factors, including:
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its efficacy, safety and potential advantages compared to alternative treatments;
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our ability to offer serlopitant for sale at competitive prices;
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the convenience and ease of administration compared to alternative treatments;
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the willingness of the target patient population to try new treatments and of physicians to prescribe these treatments;
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the risk that a competitor product may treat both the underlying condition and the associated pruritus;
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our ability to hire and retain a sales force in the United States;
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our ability to attract and retain potential commercialization collaborators in markets outside of the United States if we choose to do so;
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the strength of our marketing and distribution support;
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the availability of third‑party coverage and adequate reimbursement;
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the willingness of patients to pay out of pocket for serlopitant to the extent it is not reimbursed by third‑party payors;
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the prevalence and severity of any side effects; and
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any restrictions on the use of serlopitant together with other medications.
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If coverage and adequate reimbursement from third-party payors are not available, it may make it difficult for us to sell serlopitant profitably.
Our ability to commercialize serlopitant successfully will depend in part on the extent to which governmental authorities, private health insurers and other third‑party payors establish adequate coverage and reimbursement for it. Patients who are prescribed treatments for their conditions and providers furnishing such services generally rely on third‑party payors to reimburse all or part of the associated healthcare costs. Patients are unlikely to use our products unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of serlopitant.
Significant uncertainty exists as to the coverage and reimbursement status of newly approved products. A trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and other third‑party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medical products. Third‑party payors also are increasingly challenging the effectiveness of and prices charged for medical products and services, including requiring companies to demonstrate the comparative effectiveness of a new therapy against other types of therapies that are available. The clinical trials we have conducted and plan to conduct on serlopitant test serlopitant’s performance against a placebo. Third‑party payors may request additional trials to demonstrate comparative effectiveness. Such trials would be expensive and time consuming, and the results are uncertain. As a result of these cost containment measures, coverage and reimbursement may not be available for serlopitant when it is approved for commercialization, and, even if available, the level of reimbursement may not be sufficient enough for successful commercialization of serlopitant or may significantly limit our revenue or profits, if any.
In the United States, private third‑party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies. However, no uniform policy requirement for coverage and reimbursement for products exists among third‑party payors and coverage and reimbursement can differ significantly from payor to payor. Each plan determines whether or not it will provide coverage, what amount it will pay, and with respect to pharmaceutical products, on what tier of its formulary such product will be placed. The position of a prescription drug on a formulary generally determines the co‑payment that a patient will need to make to obtain the product and can strongly influence the adoption of a product by patients and physicians. Each plan may separately require us to provide scientific and clinical support for the use of our products and, as a result, the coverage determination process is often a time‑consuming and costly process with no assurance that coverage and adequate reimbursement will be applied consistently or obtained at all. Our inability to obtain coverage and adequate reimbursement promptly from both government‑funded and private payors for any approved products that we develop could significantly harm our operating results, our ability to raise capital needed to commercialize our product candidates and our overall financial condition.
Serlopitant may cause undesirable side effects or have other properties that could delay or prevent its regulatory approval or result in significant negative consequences following marketing approval, if any. The number of patients exposed to serlopitant treatment and the average exposure time in the clinical development program may be inadequate to detect rare adverse events, or chance findings, that may only be detected once serlopitant is administered to more patients and for greater periods of time.
Undesirable side effects caused by serlopitant could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities.
Serlopitant has been dosed in more than 1,000 individuals across 13 completed Phase 1 clinical trials and four completed Phase 2 clinical trials and has been shown to be well‑tolerated, including when administered to patients in a clinical trial for up to one year, and in shorter trials at much higher doses than our current planned therapeutic dose. However, patients may experience adverse reactions when using serlopitant. In our clinical trials, the most commonly reported treatment‑emergent adverse events across all completed Phase 2 studies were nasopharyngitis, urinary tract infection, diarrhea and headache. Although we have not seen any evidence of these reactions causing a safety concern in our clinical programs, it is possible that the FDA may ask for additional data regarding any adverse events seen in our trials.
Results of our future trials could reveal a high and unacceptable severity and prevalence of these or other side effects. In such an event, our trials could be suspended or terminated and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval for our product candidate for any or all targeted indications. The drug‑related side effects could affect patient recruitment or
the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may harm our business, financial condition and prospects significantly.
Additionally, clinical trials by their nature utilize a sample of the potential patient population. However, with a limited number of subjects and limited duration of exposure, we cannot be fully assured that rare and severe side effects of serlopitant may only be uncovered with a significantly larger number of patients exposed to the drug. If one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including:
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regulatory authorities may withdraw approvals of such product;
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regulatory authorities may require additional warnings on the label;
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we may be required to create a medication guide outlining the risks of such side effects for distribution to patients;
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we could be sued and held liable for harm caused to patients; and
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our reputation may suffer.
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We must successfully manage multiple complex clinical trials simultaneously while growing our business.
We currently have three ongoing Phase 2 clinical trials of serlopitant and we plan to initiate two Phase 3 clinical trials in the first half of 2018. If the results of our Phase 2 clinical trials are promising, we plan to rapidly advance serlopitant into Phase 3 clinical trials in up to two additional dermatologic conditions and refractory chronic cough. As of September 30, 2017, we had 25 employees. In order to manage our operations, clinical trials, regulatory filings, manufacturing and supply activities, marketing and commercialization activities for serlopitant or any future product candidates, we will need to continue to expand our managerial, operational, finance, systems, facilities and other resources. To effectively execute our strategy we must:
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manage all of our clinical trials, which are being conducted at multiple trial sites globally through multiple third parties;
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manage our internal development efforts effectively while carrying out our contractual obligations to third parties;
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expand our general and administrative and sales and marketing organizations;
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identify, recruit, retain, incentivize and integrate additional employees; and
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continue to improve our operational, legal, financial and management controls, reporting systems and procedures.
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Inability to effectively expand or manage our personnel and other resources, and complexities or unforeseen expenses or setbacks associated with managing our clinical trials and other activities, could delay or prevent completion of our planned clinical trials, the commercialization of serlopitant or any future product candidates, or the successful expansion of our product pipeline.
We are highly dependent on the services of our senior management and our ability to attract and retain qualified personnel.
Our success depends in part on our continued ability to attract, retain and motivate highly qualified personnel. In particular, we are highly dependent upon our experienced senior management, including Steven Basta, Chief Executive Officer, Paul Kwon, M.D., Chief Medical Officer and Kristine Ball, Senior Vice President, Corporate Strategy and Chief Financial Officer. The loss of services of any of these individuals could materially adversely impact our ability to sustain or grow our operations.
Although we have not historically experienced unique difficulties attracting and retaining qualified employees, we could experience such problems in the future. For example, competition for qualified personnel in the biotechnology and pharmaceuticals field is intense due to the limited number of individuals who possess the skills and experience required by our industry. In addition to the competition for personnel, the San Francisco Bay Area in particular is characterized by a high cost of living. We will need to hire additional personnel as we expand our clinical development and commercial activities, and may be required to expend significant financial resources in our employee recruitment and retention efforts. We may not be able to attract and retain quality personnel on acceptable terms, or at all. In addition, to the extent we hire personnel from competitors, we may be subject to allegations that they have been improperly solicited or that they have divulged proprietary or other confidential information, or that their former employers own their research output or other proprietary knowledge.
We may not be successful in our efforts to obtain regulatory approval of serlopitant in multiple indications concurrently or at all.
One element of our strategy is to seek approval for and commercialize serlopitant for pruritus associated with multiple dermatologic conditions. If our planned Phase 3 clinical trials of serlopitant for pruritus associated with prurigo nodularis and any Phase 3 clinical trials we may initiate for pruritus associated with atopic dermatitis and psoriasis following the completion of our Phase 2 clinical trials for such indications, are successfully completed, and such clinical trials demonstrate efficacy and safety of serlopitant in more than one indication at approximately the same time, we may seek FDA approval concurrently for the treatment of pruritus in multiple indications. There can be no assurance that we will successfully initiate any Phase 3 clinical trials for pruritus associated with atopic dermatitis and psoriasis, or that any of the Phase 3 clinical trials that we do initiate will be completed in time to permit this, or that the FDA will review or approve multiple indications simultaneously. It is possible that our strategy of pursuing multiple indications may distribute our activities in a manner that is less advantageous than a strategy that may focus on fewer indications or a single indication. It is possible that the data from trials in multiple indications could adversely affect the regulatory review of serlopitant as compared with review for a single indication. The FDA may not accept our submission in a single NDA application and we may not be able to seek approval of multiple indications for review at the same time, which could increase the time and expense required to obtain approval of multiple indications, and delay the launch of one or more of our planned indications.
We may have chosen indications for serlopitant development that are more difficult or have less commercial potential than other possible indications.
Because we have limited financial and management resources, we are focusing on development programs for specific indications. As such, we are currently primarily focused on the development of serlopitant for the treatment of pruritus associated with several dermatologic conditions and refractory chronic cough. As a result, we may forego or delay pursuit of opportunities in other indications, or with other drug candidates that we may identify or that may be available, that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on profitable market opportunities. Our spending on current and future development programs and drug candidates for specific indications may not yield any commercially viable indication. If we do not accurately evaluate the commercial potential or target market for a particular indication for serlopitant, or for any other drug candidate, we may relinquish valuable rights to that drug candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such drug candidate.
If we seek and obtain approval to commercialize serlopitant outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.
If serlopitant is approved for commercialization outside the United States, we may choose to commercialize it ourselves or enter into agreement with third parties to do so. For example, our agreement with JT Torii gives them rights to commercialize serlopitant in Japan. If we chose to commercialize internationally, we expect that we will be subject to additional risks, including:
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different regulatory requirements for drug approvals in foreign countries;
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differing United States and foreign drug import and export rules;
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different protection for intellectual property rights in foreign countries;
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unexpected changes in tariffs, trade barriers and regulatory requirements;
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different reimbursement systems, and different competitive drugs indicated to treat pruritus and refractory chronic cough;
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economic weakness, including inflation, or political instability in particular foreign economies and markets;
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compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
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foreign taxes, including withholding of payroll taxes;
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foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country;
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workforce uncertainty in countries where labor unrest is more common than in the United States;
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production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;
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potential liability resulting from development work conducted by these distributors; and
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business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters.
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Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of serlopitant or any future product candidates that we may develop.
We face an inherent risk of product liability exposure related to the testing of serlopitant in human clinical trials and will face an even greater risk if we sell commercially any drugs that we may develop. If we cannot successfully defend ourselves against claims that serlopitant causes injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:
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delays in clinical trials;
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decreased demand for serlopitant, if approved for marketing;
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injury to our reputation and significant negative media attention;
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withdrawal of clinical trial participants;
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significant costs to defend the related litigation;
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substantial monetary awards paid to trial participants or patients;
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reduced resources of our management to pursue our business strategy; and
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the inability to commercialize any drugs that we may develop.
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We currently hold $7.0 million in product liability insurance coverage in the aggregate, with a per incident limit of $7.0 million, which may not be adequate to cover all liabilities that we may incur. We may need to increase our insurance coverage as we expand our clinical trials or if we commence commercialization of our drug candidates. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.
Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
Our research and development activities and our third‑party manufacturers’ and suppliers’ activities involve the controlled storage, use and disposal of hazardous materials, including the components of our product and product candidates and other hazardous compounds. We and our manufacturers and suppliers are subject to laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials. In some cases, these hazardous materials and various wastes resulting from their use are stored at our and our manufacturers’ facilities pending their use and disposal. We cannot eliminate the risk of contamination, which could cause an interruption of our commercialization efforts, research and development efforts and business operations, environmental damage resulting in costly clean‑up and liabilities under applicable laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. Although we believe that the safety procedures utilized by our third‑party manufacturers for handling and disposing of these materials generally comply with the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminate the risk of accidental contamination or injury from these materials. In such an event, we may be held liable for any resulting damages and such liability could exceed our resources and state or federal or other applicable authorities may curtail our use of certain materials and/or interrupt our business operations. Furthermore, environmental laws and regulations are complex, change frequently and have tended to become more stringent. We cannot predict the impact of such changes and cannot be certain of our future compliance. We do not currently carry biological or hazardous waste insurance coverage.
Significant disruptions of information technology systems or breaches of data security could materially adversely affect our business, results of operations and financial condition.
We collect and maintain information in digital form that is necessary to conduct our business, and we are increasingly dependent on information technology systems and infrastructure to operate our business. In the ordinary course of our business, we collect, store and transmit large amounts of confidential information, including intellectual property, proprietary business information and personal information. It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information. We have established physical, electronic and organizational measures to safeguard and secure our systems to prevent a data compromise, and rely on commercially available systems, software, tools and monitoring to provide security for our information technology systems and the processing, transmission and storage of digital information. We have also outsourced elements of our information technology infrastructure, and as a result a number of third‑party vendors may or could have access to our confidential information. Our internal information technology systems and infrastructure, and those of our current and any future collaborators, contractors and consultants and other third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber‑attacks or cyber‑intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside our organization.
The risk of a security breach or disruption, particularly through cyber‑attacks or cyber intrusion, including by computer hackers, foreign governments and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. In addition, the prevalent use of mobile devices that access confidential information increases the risk of data security breaches, which could lead to the loss of confidential information or other intellectual property. The costs to us to mitigate network security problems, bugs, viruses, worms, malicious software programs and security vulnerabilities could be significant, and while we have implemented security measures to protect our data security and information technology systems, our efforts to address these problems may not be successful, and these problems could result in unexpected interruptions, delays, cessation of service and other harm to our business and our competitive position. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our product development programs. For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Moreover, if a computer security breach affects our systems or results in the unauthorized release of personally identifiable information, our reputation could be materially damaged. In addition, such a breach may require notification to governmental agencies, the media or individuals pursuant to various federal and state privacy and security laws, if applicable, including the Health
Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Clinical Health Act of 2009, and its implementing rules and regulations, as well as regulations promulgated by the Federal Trade Commission and state breach notification laws. We would also be exposed to a risk of loss or litigation and potential liability, which could materially adversely affect our business, results of operations and financial condition.
We or the third parties upon whom we depend may be adversely affected by earthquakes or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
Our corporate headquarters and other facilities are located in the San Francisco Bay Area, which in the past has experienced severe earthquakes. We do not carry earthquake insurance. Earthquakes or other natural disasters could severely disrupt our operations, and have a material adverse effect on our business, results of operations, financial condition and prospects.
If a natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of our headquarters, that damaged critical infrastructure, such as our enterprise financial systems or manufacturing resource planning and enterprise quality systems, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time. The disaster recovery and business continuity plans we have in place currently are limited and are unlikely to prove adequate in the event of a serious disaster or similar event. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which, particularly when taken together with our lack of earthquake insurance, could have a material adverse effect on our business.
Furthermore, integral parties in our supply chain are operating from single sites, increasing their vulnerability to natural disasters or other sudden, unforeseen and severe adverse events. If such an event were to affect our supply chain, it could have a material adverse effect on our business.
Risks Related to Our Intellectual Property
We may become subject to claims alleging infringement of third parties’ patents or proprietary rights and/or claims seeking to invalidate our patents, which would be costly, time consuming and, if successfully asserted against us, delay or prevent the development and commercialization of serlopitant or any future product candidates.
There have been many lawsuits and other proceedings asserting patents and other intellectual property rights in the pharmaceutical and biotechnology industries. We cannot assure you that serlopitant or any future product candidates will not infringe existing or future third‑party patents. Because patent applications can take many years to issue and may be confidential for 18 months or more after filing, there may be applications now pending of which we are unaware and which may later result in issued patents that we may infringe by commercializing serlopitant or future product candidates. Moreover, we may face claims from non‑practicing entities that have no relevant product revenue and against whom our own patent portfolio may thus have no deterrent effect. We may be unaware of one or more issued patents that would be infringed by the manufacture, sale or use of serlopitant.
We may be subject to third‑party claims in the future against us or our collaborators that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial damages, including treble damages and attorney’s fees if we are found to be willfully infringing a third‑party’s patents. We may be required to indemnify future collaborators against such claims. If a patent infringement suit were brought against us or our collaborators, we or they could be forced to stop or delay research, development, manufacturing or sales of the product or product candidate that is the subject of the suit. As a result of patent infringement claims, or in order to avoid potential claims, we or our collaborators may choose to seek, or be required to seek, a license from the third‑party and would most likely be required to pay license fees or royalties or both. These licenses may not be available on acceptable terms, or at all. Even if we or our collaborators were able to obtain a license, the rights may be nonexclusive, which would give our competitors access to the same intellectual property. Ultimately, we could be prevented from commercializing a product, or forced to redesign it, or to cease some aspect of our business operations if, as a result of actual or threatened patent infringement claims, we or our collaborators are unable to enter into licenses on acceptable terms. Even if we are successful in defending against such claims, such litigation can be expensive and time consuming to litigate and would
divert management’s attention from our core business. Any of these events could harm our business significantly.
In addition to infringement claims against us, if third parties prepare and file patent applications in the United States that also claim technology similar or identical to ours, we may have to participate in interference or derivation proceedings in the United States Patent and Trademark Office, or the USPTO, to determine which party is entitled to a patent on the disputed invention. We may also become involved in similar opposition proceedings in the European Patent Office or similar offices in other jurisdictions regarding our intellectual property rights with respect to our products and technology. Since patent applications are confidential for a period of time after filing, we cannot be certain that we were the first to file any patent application related to our product candidates.
If our intellectual property related to serlopitant or any future product candidates is not adequate, we may not be able to compete effectively in our market.
We rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related to serlopitant and our development programs. Patents covering the composition of matter for serlopitant will expire in 2025, subject to potential extensions, where available, including, potential extension of up to five years in the United States. Patents and patent applications, if issued, covering methods‑of‑use for serlopitant to treat pruritus will expire in 2033 in the United States and 2034 in foreign countries. We have filed a U.S. provisional patent application covering methods‑of‑use of serlopitant to treat refractory chronic cough, but there can be no assurance that such patent will issue. The expiration of our patents will limit our ability to profit from the commercialization of serlopitant. Furthermore, any disclosure to or misappropriation by third parties of our confidential or proprietary information could enable competitors to quickly duplicate or surpass our technological achievements, thus eroding our competitive position in our market.
The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain. The patent applications that we own, co‑own, or license may fail to result in issued patents in the United States or in foreign countries. Even if patents do successfully issue, third parties may challenge the validity, enforceability or scope thereof, which may result in such patents being narrowed, invalidated or held unenforceable. For example, patents granted by the USPTO may be subject to third‑party challenges such as (without limitation) re‑examination proceedings, post‑grant review, or
inter partes
review, and patents granted by the European Patent Office may be opposed by any person within nine months from the publication of the grant. Similar proceedings are available in other jurisdictions, and in some jurisdictions third parties can raise questions of validity with a patent office even before a patent has granted. Furthermore, even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property or prevent others from designing around our claims. For example, a third‑party may develop a competitive product that provides therapeutic benefits similar to serlopitant but has a sufficiently different composition to fall outside the scope of our patent protection. If the breadth or strength of protection provided by the patents and patent applications we hold or pursue with respect to serlopitant or any future product candidates is successfully challenged, then our ability to commercialize serlopitant or any future product candidates could be negatively affected, and we may face unexpected competition that could have a material adverse impact on our business. Further, if we encounter delays in our clinical trials, the period of time during which we could market serlopitant or any future product candidates under patent protection would be reduced.
Even where laws provide protection, costly and time‑consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and the outcome of such litigation would be uncertain. If we or one of our future collaborators were to initiate legal proceedings against a third party to enforce a patent covering serlopitant or one of our future products, the defendant could counterclaim that our patent is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness or non‑enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to validity, for example, we cannot be certain that there is no invalidating prior art, of which we and the patent examiner were
unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability against our intellectual property related to serlopitant, we would lose at least part, and perhaps all, of the patent protection on serlopitant. Such a loss of patent protection would have a material adverse impact on our business. Moreover, our competitors could counterclaim that we infringe their intellectual property, and some of our competitors have substantially greater intellectual property portfolios than we do.
We also rely on trade secret protection and confidentiality agreements to protect proprietary know‑how that may not be patentable, processes for which patents may be difficult to obtain and/or enforce and any other elements of our product development processes that involve proprietary know‑how, information or technology that is not covered by patents. Although we require all of our employees to assign their inventions to us, and endeavor to execute confidentiality agreements with all of our employees, consultants, advisors and any third parties who have access to our proprietary know‑how, information or technology, we cannot be certain that we have executed such agreements with all parties who may have helped to develop our intellectual property or who had access to our proprietary information, nor can we be certain that our agreements will not be breached. We cannot guarantee that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Further, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad. If we are unable to prevent material disclosure of the intellectual property related to our technologies to third parties, we will not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, results of operations and financial condition.
Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity. Therefore, obtaining and enforcing biopharmaceutical patents is costly, time consuming and inherently uncertain. In addition, the United States has recently enacted and is currently implementing wide‑ranging patent reform legislation. The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents once obtained. Depending on future actions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
The USPTO and various foreign patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions to maintain patent applications and issued patents. Noncompliance with these requirements can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case.
We have not yet registered trademarks for a commercial trade name for serlopitant in the United States or elsewhere and failure to secure such registrations could adversely affect our business.
We have not yet registered trademarks for a commercial trade name for serlopitant in the United States or elsewhere. During trademark registration proceedings, our trademark application may be rejected. Although we are given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In addition, in the USPTO and in comparable agencies in many foreign jurisdictions, third parties can oppose pending trademark applications and seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such proceedings. Moreover, any name we propose to use with our product candidates in the United States must be approved by
the FDA, regardless of whether we have registered it, or applied to register it, as a trademark. The FDA typically conducts a review of proposed product names, including an evaluation of potential for confusion with other product names. If the FDA objects to any of our proposed proprietary product names, we may be required to expend significant additional resources in an effort to identify a suitable substitute name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA.
We may not be able to enforce our intellectual property rights throughout the world.
The laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States. Many companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions. The legal systems of some countries, particularly developing countries, do not favor the enforcement of patents and other intellectual property protection, especially those relating to life sciences. This could make it difficult for us to stop the infringement of our patents or the misappropriation of our other intellectual property rights. For example, many foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties. In addition, many countries limit the enforceability of patents against third parties, including government agencies or government contractors. In these countries, patents may provide limited or no benefit.
Proceedings to enforce our patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business. Furthermore, while we intend to protect our intellectual property rights in our expected significant markets, we cannot ensure that we will be able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market serlopitant or any future products. Accordingly, our efforts to protect our intellectual property rights in such countries may be inadequate. In addition, changes in the law and legal decisions by courts in the United States and foreign countries may affect our ability to obtain and enforce adequate intellectual property protection for our technology.
If we are unable to protect the confidentiality of our proprietary information and know‑how, the value of our technology and products could be adversely affected.
We may not be able to protect our proprietary information and technology adequately. Although we use reasonable efforts to protect our proprietary information, technology, and know‑how, our employees, consultants, contractors and outside scientific advisors may unintentionally or willfully disclose our information to competitors. Enforcing a claim that a third party illegally obtained and is using any of our proprietary information, technology or know‑how is expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States are sometimes less willing to protect proprietary information, technology and know‑how. We rely, in part, on non‑disclosure and confidentiality agreements with our employees, consultants and other parties to protect our proprietary information, technology and know‑how. These agreements may be breached and we may not have adequate remedies for any breach. Moreover, others may independently develop similar or equivalent proprietary information, and third parties may otherwise gain access to our proprietary knowledge.
Our intellectual property agreements with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology or increase our financial or other obligations to our licensors.
Certain provisions in our intellectual property agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could affect the scope of our rights to the relevant intellectual property or technology, or affect financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations and prospects.
In addition, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact conceives or develops intellectual property that we regard as our own. Our assignment agreements may not be self‑executing or may be breached, and we may be forced to bring claims against third parties, or defend claims they may bring against us, to determine the ownership of what we regard as our intellectual property.
Risks Related to Government Regulation
The regulatory approval process is lengthy, time-consuming, and highly uncertain, and we may experience significant delays and may not obtain regulatory approval for the commercialization of serlopitant or any future product candidates.
The research, testing, manufacturing, labeling, approval, selling, import, export, marketing and distribution of drug products are subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries, which regulations differ from country to country. We currently have no products approved for sale, and we may never obtain regulatory approval to commercialize serlopitant. Neither we nor any current or future collaborator is permitted to market serlopitant or any future product candidate in the United States or in any foreign countries until we or they receive approval of an NDA from the FDA or marketing authorization from the applicable regulatory authorities of such jurisdictions. We have not submitted an application or obtained marketing approval for serlopitant anywhere in the world. Obtaining regulatory approval of an NDA can be a lengthy, expensive and uncertain process. In addition, failure to comply with FDA and other applicable United States and foreign regulatory requirements may subject us to administrative or judicially imposed sanctions or other actions, including:
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warning or untitled letters;
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civil and criminal penalties;
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withdrawal of regulatory approval of products;
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product seizure or detention;
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total or partial suspension of production; and
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refusal to approve pending NDAs or supplements to approved NDAs.
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Prior to obtaining approval to commercialize a drug candidate in the United States or abroad, we or our collaborators must demonstrate with substantial evidence from well‑controlled clinical trials, and to the satisfaction of the FDA or other foreign regulatory agencies, that such drug candidate is safe and effective for its intended uses.
The number of non-clinical studies and clinical trials that will be required for FDA approval varies depending on many factors, including the drug candidate, the disease or condition that the drug candidate is designed to address, and results of non-clinical studies and clinical trials of the drug candidate.
Even if we believe the non‑clinical or clinical data for our drug candidates is promising, such data may not be sufficient to support approval by the FDA and other regulatory authorities. Administering drug candidates to humans may produce undesirable side effects, which could interrupt, delay or halt clinical trials and result in the FDA or other regulatory authorities denying approval of a drug candidate for any or all targeted indications.
Regulatory approval of an NDA is not guaranteed, and the approval process is expensive and may take several years. The FDA also has substantial discretion in the approval process and we may encounter matters with the FDA that requires us to expend additional time and resources and delay or prevent the approval of our product candidates. For example, the FDA may require us to conduct additional studies or trials for serlopitant either prior to or post‑approval, such as additional drug‑drug interaction studies or safety or efficacy studies or trials, or it may object to elements of our clinical development program such as the number of subjects in our current clinical trials from the United States. The FDA can delay, limit or deny approval of a drug candidate for many reasons, including, but not limited to, the following:
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a drug candidate may not be deemed safe or effective;
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FDA officials may not find the data from non‑clinical studies and clinical trials sufficient;
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the FDA might not approve our third‑party manufacturers’ processes or may find objectionable conditions at our third‑party manufacturers’ facilities that must be corrected before our drug candidate can be approved; or
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the FDA may change its approval policies or adopt new regulations.
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If serlopitant or any future product candidate fails to demonstrate safety and efficacy in clinical trials or does not gain regulatory approval, our business and results of operations will be materially and adversely harmed. Additionally, if the FDA requires that we conduct additional clinical studies, places limitations on serlopitant in our label, delays approval to market serlopitant or limits the use of serlopitant, our business and results of operations may be harmed.
Even if we receive regulatory approval of serlopitant or any future product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
Any regulatory approvals or other marketing authorizations we obtain for serlopitant or any future product candidates may be subject to limitations on the indicated uses for which the product may be marketed or the conditions of approval or marketing authorization, or contain requirements for potentially costly post‑market testing and surveillance to monitor the safety and efficacy of the product candidate. In addition, if the FDA or a comparable foreign regulatory authority authorizes our product candidates for marketing, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and record keeping for our product candidates will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post‑marketing information and reports, registration, as well as continued compliance with cGMPs, and GCP requirements for any clinical trials that we conduct post‑approval. Later discovery of previously unknown problems with our product candidates, including adverse events of unanticipated severity or frequency, or with our third‑party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:
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restrictions on the marketing or manufacturing of our product, withdrawal of the product from the market, or product recalls;
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fines, warning or untitled letters or holds on clinical trials;
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refusal by the FDA to accept new marketing applications or supplements, approve or otherwise authorize for marketing pending applications or supplements to applications filed by us or current or future collaborators or suspension or revocation of approvals or other marketing authorizations;
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product seizure or detention, or refusal to permit the import or export of our product; and
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injunctions or the imposition of civil or criminal penalties.
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The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. For example, in December 2016, the 21st Century Cures Act, or Cures Act, was signed into law. The Cures Act, among other things, is intended to modernize the regulation of drugs and devices and to spur innovation, but its ultimate implementation is unclear. In addition, in August 2017, the FDA Reauthorization Act was signed into law, which reauthorized the FDA’s user fee programs and included additional drug and device provisions that build on the Cures Act. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we
may not obtain marketing approval or
we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability, which would adversely affect our business, prospects, financial condition and results of operations.
A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and other third‑party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medical products and services, implementing reductions in Medicare and other healthcare funding, and applying new payment methodologies. For example, in March 2010, the
Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, collectively the
Affordable Care Act,
was enacted, which, among other things, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; introduced a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; extended the Medicaid Drug Rebate Program to utilization of prescriptions of individuals enrolled in Medicaid managed care plans; imposed mandatory discounts for certain Medicare Part D beneficiaries as a condition for manufacturers’ outpatient drugs coverage under Medicare Part D; subjected drug manufacturers to new annual fees based on pharmaceutical companies’ share of sales to federal healthcare programs; imposed a new federal excise tax on the sale of certain medical devices; created a new Patient Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; created the Independent Payment Advisory Board, which, once empaneled, will have authority to recommend certain changes to the Medicare program that could result in reduced payments for prescription drugs; and established a Center for Medicare Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending.
Since its enactment, there have been judicial and Congressional challenges to certain aspects of the Affordable Care Act, and we expect there will be additional challenges and amendments to the Affordable Care Act in the future. The Trump administration and members of the U.S. Congress have indicated that they may continue to seek to modify, repeal, or otherwise invalidate all, or certain provisions of, the Affordable Care Act. It is uncertain the extent to which any such changes may impact our business or financial condition.
In addition, we cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. For example, certain policies of the Trump administration may impact our business and industry. Namely, the Trump administration has taken several executive actions, including the issuance of a number of Executive Orders, that could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine regulatory and oversight activities such as implementing statutes through rulemaking, issuance of guidance, and review and approval of marketing applications. Notably, on January 30, 2017, President Trump issued an Executive Order, applicable to all executive agencies, including the FDA, that requires that for each notice of proposed rulemaking or final regulation to be issued in fiscal year 2017, the agency shall identify at least two existing regulations to be repealed, unless prohibited by law. These requirements are referred to as the “two‑for‑one” provisions. This Executive Order includes a budget neutrality provision that requires the total incremental cost of all new regulations in the 2017 fiscal year, including repealed regulations, to be no greater than zero, except in limited circumstances. For fiscal years 2018 and beyond, the Executive Order requires agencies to identify regulations to offset any incremental cost of a new regulation and approximate the total costs or savings associated with each new regulation or repealed regulation. In interim guidance issued by the Office of Information and Regulatory Affairs within the Office of Management and Budget, or OMB, on February 2, 2017, the administration indicates that the “two‑for‑one” provisions may apply not only to agency regulations, but also to significant agency guidance documents. In addition, on February 24, 2017, President Trump issued an executive order directing each affected agency to designate an agency official as a “Regulatory Reform Officer” and establish a “Regulatory Reform Task Force” to implement the two‑for‑one provisions and other previously issued executive orders relating to the review of federal regulations, and on September 8, 2017, the FDA published notices in the Federal Register soliciting broad public comment to identify regulations that could be modified in compliance with these Executive Orders. It is difficult to predict how these requirements will be implemented, and the extent to which they will impact the FDA’s ability to exercise its regulatory authority. If these executive actions impose constraints on the FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted.
We expect that any regulatory approval to market serlopitant in the United States will be limited by indication. If we fail to comply or are found to be in violation of FDA and other regulations restricting the promotion of serlopitant for unapproved uses, we could be subject to criminal penalties, substantial fines or other sanctions and damage awards.
If our clinical trials are successful, we intend to seek approval to market serlopitant for the treatment of pruritus associated with specified dermatologic conditions, as well as for refractory chronic cough. We do not have plans to seek approval of serlopitant for any other indication at this time, including for the treatment of pruritus associated with any dermatologic condition other than atopic dermatitis, psoriasis or prurigo nodularis. If we obtain regulatory approval to market serlopitant with an indication statement for the treatment of one or more of these indications, we will likely be prohibited from marketing serlopitant using any promotional claims relating
to treatment of pruritus generally. Marketing of serlopitant may also be limited by regulatory authorities based on use as a monotherapy or adjuvant, concomitant medications, severity of pruritus and other factors.
The regulations relating to the promotion of products for unapproved uses are complex and subject to substantial interpretation by the FDA and other government agencies. While serlopitant is being studied in pruritus associated with each of atopic dermatitis, psoriasis and prurigo nodularis, as well as refractory chronic cough, serlopitant may not be promoted for uses that are not approved in the labeling by the FDA or EMA. Physicians may nevertheless prescribe serlopitant off‑label to their patients in a manner that is inconsistent with the approved label. We intend to implement compliance and training programs designed to ensure that our sales and marketing practices comply with applicable regulations. Notwithstanding these programs, the FDA or other government agencies may allege or find that our practices constitute prohibited promotion of serlopitant for unapproved uses. We also cannot be sure that our employees will comply with company policies and applicable regulations regarding the promotion of products for unapproved uses.
In recent years, a significant number of pharmaceutical and biotechnology companies have been the target of inquiries and investigations by various federal and state regulatory, investigative, prosecutorial and administrative entities in connection with the promotion of products for unapproved uses and other sales practices, including the Department of Justice and various U.S. Attorneys’ Offices, the Office of Inspector General of the Department of Health and Human Services, the FDA, the Federal Trade Commission and various state Attorneys General offices. These investigations have alleged violations of various federal and state laws and regulations, including claims asserting antitrust violations, violations of the Federal Food, Drug and Cosmetic Act, the False Claims Act, the Prescription Drug Marketing Act, anti‑kickback laws and other alleged violations in connection with the promotion of products for unapproved uses, pricing and Medicare and/or Medicaid reimbursement. Many of these investigations originate as “
qui tam
” actions under the False Claims Act. Under the False Claims Act, any individual can bring a claim on behalf of the government alleging that a person or entity has presented a false claim, or caused a false claim to be submitted, to the government for payment. The person bringing a
qui tam
suit is entitled to a share of any recovery or settlement.
Qui tam
suits, also commonly referred to as “whistleblower suits,” are often brought by current or former employees. In a
qui tam
suit, the government must decide whether to intervene and prosecute the case. If it declines, the individual may pursue the case alone.
If the FDA or any other governmental agency initiates an enforcement action against us or if we are the subject of a
qui tam
suit and it is determined that we violated prohibitions relating to the promotion of products for unapproved uses, we could be subject to substantial civil or criminal fines or damage awards and other sanctions such as consent decrees and corporate integrity agreements pursuant to which our activities would be subject to ongoing scrutiny and monitoring to ensure compliance with applicable laws and regulations. Any such fines, awards or other sanctions would have an adverse effect on our revenue, business, financial prospects and reputation.
If approved, serlopitant or any future products may cause or contribute to adverse medical events that we are required to report to regulatory agencies and if we fail to do so we could be subject to sanctions that would materially harm our business.
If we are successful in commercializing serlopitant or any other products, FDA and foreign regulatory agency regulations require that we report certain information about adverse medical events if those products may have caused or contributed to those adverse events. The timing of our obligation to report would be triggered by the date we become aware of the adverse event as well as the nature of the event. We may fail to report adverse events we become aware of within the prescribed time frame. We may also fail to appreciate that we have become aware of a reportable adverse event, especially if it is not reported to us as an adverse event or if it is an adverse event that is unexpected or removed in time from the use of our products. If we fail to comply with our reporting obligations, the FDA or a foreign regulatory agency could take action, including criminal prosecution, the imposition of civil monetary penalties, seizure of our products or delay in approval or clearance of future products.
If third-party manufacturers fail to comply with manufacturing regulations, our financial results and financial condition will be adversely affected.
Before our contract manufacturers can begin commercial manufacture of serlopitant, the process and systems used in the manufacture of serlopitant must be approved and each facility must have a compliance status that is acceptable to the FDA and other regulatory authorities.
In addition, pharmaceutical manufacturing facilities are continuously subject to inspection by the FDA and foreign regulatory authorities, before and after product approval. Due to the complexity of the processes used to manufacture pharmaceutical products and product candidates, any potential third‑party manufacturer may be unable to continue to pass or initially pass federal, state or international regulatory inspections in a cost‑effective manner.
Furthermore, although we do not have day‑to‑day control over the operations of our contract manufacturers, we are responsible for ensuring compliance with applicable laws and regulations, including cGMPs.
If a third‑party manufacturer with whom we contract is unable to comply with
applicable laws and regulations, including cGMP
s, serlopitant may not be approved, or we may be subject to fines, unanticipated compliance expenses, recall or seizure of our products, total or partial suspension of production and/or enforcement actions, including injunctions, and criminal or civil prosecution. These possible sanctions would adversely affect our financial results and financial condition.
Our failure to obtain regulatory approvals for serlopitant in foreign jurisdictions would prevent us from marketing our products internationally.
In order to market any product in the European Economic Area, or EEA (which is composed of the 28 Member States of the European Union plus Norway, Iceland and Liechtenstein), and many other foreign jurisdictions, separate regulatory approvals are required. In the EEA, medicinal products can only be commercialized after obtaining a Marketing Authorization, or MA. Before granting the MA, the European Medicines Agency, or EMA, or the competent authorities of the Member States of the EEA make an assessment of the risk‑benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.
The approval procedures vary among countries and can involve additional clinical testing, and the time required to obtain approval may differ from that required to obtain FDA approval. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries. Approval by the FDA does not ensure approval by regulatory authorities in other countries, and approval by one or more foreign regulatory authorities does not ensure approval by regulatory authorities in other foreign countries or by the FDA. However, a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in others. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval. We may not be able to file for regulatory approvals or to do so on a timely basis, and even if we do file we may not receive necessary approvals to commercialize our products in any market.
We may be subject to healthcare laws and regulations relating to our business, and could face substantial penalties if we are determined not to have fully complied with such laws, which would have an adverse impact on our business.
Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third‑party payors, customers and patients, may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations. These laws may constrain the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute our products for which we obtain marketing approval. Such laws include:
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the U.S. federal Anti‑Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under a U.S. healthcare program such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the U.S. federal Anti‑Kickback Statute or specific intent to violate it in order to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the U.S. federal Anti‑Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act;
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U.S. federal civil and criminal false claims laws and civil monetary penalties laws, including the civil False Claims Act, which, among other things, impose criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the U.S. government, claims for payment or approval that are false or fraudulent, knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or from knowingly making a false statement to avoid, decrease or conceal an obligation to pay money to the U.S. government;
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the U.S. Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items or services. Similar to the U.S. federal Anti‑Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations, which also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without appropriate authorization by covered entities subject to the rule, such as health plans, healthcare clearinghouses and healthcare providers as well as their business associates that perform certain services for or on their behalf involving the use or disclosure of individually identifiable health information;
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the U.S. Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the government information related to payments or other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and requires applicable manufacturers and group purchasing organizations to report annually to the government ownership and investment interests held by the physicians described above and their immediate family members;
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federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; and
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analogous state and non‑U.S. laws and regulations, such as state anti‑kickback and false claims laws, which may apply to our business practices, including, but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by non‑governmental third‑party payors, including private insurers; state laws that require pharmaceutical and device companies to comply with the industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws and regulations that require manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information; and state and non‑U.S. laws governing the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
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Efforts to ensure that our current and future business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities may conclude that our business practices, including our consulting and advisory board arrangements with physicians and other healthcare providers, some of whom receive stock options as compensation for services provided, do not comply with current or future statutes, regulations, agency guidance or case law involving applicable healthcare laws. If our operations are found to be in violation of any of these or any other health regulatory laws that may apply to us, we may be subject to significant penalties, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgement, individual imprisonment, possible exclusion from participation in Medicare, Medicaid and other U.S. healthcare programs,
contractual damages, reputational harm, diminished profits and future earnings, and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. Defending against any such actions can be costly, time‑consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired. If any of the above occur, it 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 for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain.
In the United States and some non‑U.S. jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could, among other things, prevent or delay marketing approval of our product candidates, restrict or regulate post‑approval activities and affect our ability to profitably sell any product candidates for which we obtain marketing approval.
For example, in March 2010, the Affordable Care Act was enacted in the United States to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms. The law has continued the downward pressure on the pricing of medical items and services, especially under the Medicare program, and increased the industry’s regulatory burdens and operating costs. Among the provisions of the Affordable Care Act of importance to our potential product candidates are the following:
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an annual, nondeductible fee payable by any entity that manufactures or imports specified branded prescription drugs and biologic agents;
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an annual excise tax of 2.3% on any entity that manufactures or imports medical devices offered for sale in the United States which, due to subsequent legislative amendments, has been suspended from January 1, 2016 to December 31, 2017, and, absent further legislative action, will be reinstated starting January 1, 2018;
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an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program;
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a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected;
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a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point‑of‑sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;
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extension of manufacturers’ Medicaid rebate liability to individuals enrolled in Medicaid managed care organizations;
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expansion of eligibility criteria for Medicaid programs in certain states;
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expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
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a new requirement to annually report drug samples that manufacturers and distributors provide to physicians;
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a new Patient‑Centered Outcomes Research Institute to oversee, identify priorities in and conduct comparative clinical effectiveness research, along with funding for such research; and
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an independent payment advisory board that will submit recommendations to Congress to reduce Medicare spending if projected Medicare spending exceeds a specified growth rate.
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Since its enactment, there have been judicial and Congressional challenges to certain aspects of the Affordable Care Act, and we expect there will be additional challenges and amendments to the Affordable Care Act in the future. The new Presidential Administration and U.S. Congress will likely continue to seek to modify, repeal, or otherwise invalidate all, or certain provisions of, the Affordable Care Act. It is uncertain the extent to which any such changes may impact our business or financial condition.
In addition, other legislative changes have been proposed and adopted in the United States since the Affordable Care Act was enacted. These changes include the Budget Control Act of 2011, which, among other things, resulted in reductions to Medicare payments to providers of 2% per fiscal year and will remain in effect through 2025; the American Taxpayer Relief Act of 2012, which, among other things, further reduced Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years; and the Medicare Access and CHIP Reauthorization Act of 2015, which, among other things, ended the use of the sustainable growth rate formula and provides for a 0.5% update to physician payment rates for each calendar year through 2019, after which there will be a 0% annual update each year through 2025. More recently, there 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 pharmaceutical products.
Individual states in the United States have also become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical product and medical device pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, in October 2017, California passed a new law, to become effective in January 2019, which will require transparency from biopharmaceutical companies regarding price increases for prescription drugs. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and medical devices to purchase and which suppliers will be included in their prescription drug and other healthcare programs.
We expect that the Affordable Care Act, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria, new payment methodologies and in additional downward pressure on the price that we receive for any approved or cleared product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to new requirements or policies, or if we are not able to maintain regulatory compliance, our product candidates may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability, which would adversely affect our business.
Risks Related to this Offering, Ownership of Our Common Stock and Our Status as a Public Company
An active trading market for our common stock may not develop and you may not be able to resell your shares of our common stock at or above the initial offering price, if at all.
Prior to this offering, there has been no public market for our common stock. The initial public offering price for our common stock will be determined through negotiations with the underwriters and may not be indicative of the price at which our common stock will trade after the closing of this offering. Although we have applied to list our common stock on the Nasdaq Global Market, an active trading market for our shares may never develop or be sustained following this offering. If an active market for our common stock does not develop or is not sustained, it may be difficult for you to sell shares you purchased in this offering at an attractive price or at all.
The trading price of the shares of our common stock may be volatile, and purchasers of our common stock could incur substantial losses.
Our stock price may be volatile. The stock market in general and the market for biopharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, investors may not be able to sell their common stock at or
above the price paid for the shares. The market price for our common stock may be influenced by many factors, including:
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the commencement, enrollment or results of our ongoing and planned clinical trials of serlopitant or any future clinical trials we may conduct, or changes in the development status of serlopitant;
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announcements of clinical trials results by competitors;
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adverse results from, delays in or termination of clinical trials;
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any delay in our regulatory filings for serlopitant or any other drug candidate and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to file” letter or a request for additional information;
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adverse regulatory decisions, including failure to receive regulatory approval of our drug candidates;
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unanticipated serious safety concerns related to the use of serlopitant or any other drug candidate;
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changes in financial estimates by us or by any securities analysts who might cover our stock;
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conditions or trends in our industry;
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changes in the market valuations of similar companies;
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stock market price and volume fluctuations of comparable companies and, in particular, those that operate in the biopharmaceutical industry;
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publication of research reports about us or our industry or positive or negative recommendations or withdrawal of research coverage by securities analysts;
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announcements by us or our competitors of significant acquisitions, strategic partnerships or divestitures;
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announcements of investigations or regulatory scrutiny of our operations or lawsuits filed against us;
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investors’ general perception of our company and our business;
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recruitment or departure of key personnel;
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overall performance of the equity markets;
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trading volume of our common stock;
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disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
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significant lawsuits, including patent or stockholder litigation;
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general political and economic conditions; and
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other events or factors, many of which are beyond our control.
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In addition, in the past, stockholders have initiated class action lawsuits against pharmaceutical and biotechnology companies following periods of volatility in the market prices of these companies’ stock. Such litigation, if instituted against us, could cause us to incur substantial costs and divert management’s attention and resources from our business.
If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.
The trading market for our common stock will be influenced by the research and reports that equity research analysts publish about us and our business. We do not currently have and may never obtain research coverage by equity research analysts. Equity research analysts may elect not to provide research coverage of our common stock after this offering, and such lack of research coverage may adversely affect the market price of our common stock. In the event we do have equity research analyst coverage, we will not have any control over the analysts or the content and opinions included in their reports. The price of our stock could decline if one or more equity research analysts downgrade our stock or issue other unfavorable commentary or research. If one or more equity research analysts ceases coverage of our company or fails to publish reports on us regularly, demand for our stock could decrease, which in turn could cause our stock price or trading volume to decline.
If you purchase shares of our common stock in this offering, you will suffer immediate dilution of your investment.
We expect the initial public offering price of our common stock to be substantially higher than the net tangible book value per share of our common stock. Therefore, if you purchase shares of our common stock in this offering, you will pay a price per share that substantially exceeds our pro forma as adjusted net tangible book value per share after this offering. Based on an assumed initial public offering price of $
per share, which is the midpoint of the price range set forth on the cover page of this prospectus, you will experience immediate dilution of $
per share, representing the difference between our pro forma as adjusted net tangible book value per share after this offering and the assumed initial public offering price.
In addition, as of September 30, 2017, we had outstanding stock options to purchase an aggregate of
5,807,569
shares of common stock at a weighted average exercise price of $1.07 per share. To the extent these outstanding options are exercised, there will be further dilution to investors in this offering.
A significant portion of our total outstanding shares are restricted from immediate resale but may be sold into the market in the near future. This could cause the market price of our common stock to drop significantly, even if our business is doing well.
Sales of a substantial number of shares of our common stock in the public market could occur at any time. If our stockholders sell, or the market perceives that our stockholders intend to sell, substantial amounts of our common stock in the public market following this offering, the market price of our common stock could decline significantly.
Upon the closing of this offering, we will have outstanding
shares of common stock, after giving effect to the conversion of our convertible preferred stock outstanding as of September 30, 2017 into 25,975,346 shares of our common stock, and assuming no exercise of outstanding options or warrants. Of these shares, the
shares sold in this offering will be freely tradable and
additional shares of common stock will be available for sale in the public market beginning 180 days after the date of this prospectus following the expiration of lock‑up agreements between some of our stockholders and the underwriters.
Jefferies LLC and Piper Jaffray & Co.
may release these stockholders from their lock‑up agreements with the underwriters at any time and without notice, which would allow for earlier sales of shares in the public market.
In addition, promptly following the closing of this offering, we intend to file one or more registration statements on Form S‑8 under the Securities Act registering the issuance of approximately
shares of common stock subject to options or other equity awards issued or reserved for future issuance under our equity incentive plans. Shares registered under these registration statements on Form S‑8 will be available for sale in the public market subject to vesting arrangements and exercise of options, the lock‑up agreements described above and the restrictions of Rule 144 in the case of our affiliates.
Additionally, after this offering, the holders of an aggregate of approximately 33.9 million shares of our common stock, or their transferees, will have rights, subject to some conditions, to require us to file one or more registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders. If we were to register the resale of these shares, they could be freely sold in the public market. If these additional shares are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could decline.
Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as a result.
Our amended and restated certificate of incorporation and amended and restated bylaws that will be in effect immediately prior to the completion of this offering will contain provisions that could delay or prevent changes in control or changes in our management without the consent of our board of directors. These provisions will include the following:
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a classified board of directors with three‑year staggered terms, which may delay the ability of stockholders to change the membership of a majority of our board of directors;
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no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;
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the exclusive right of our board of directors to elect a director to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors;
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the ability of our board of directors to authorize the issuance of shares of preferred stock and to determine the price and other terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquiror;
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the ability of our board of directors to alter our bylaws without obtaining stockholder approval;
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the required approval of at least 66 2/3% of the shares entitled to vote at an election of directors to adopt, amend or repeal our bylaws or repeal the provisions of our amended and restated certificate of incorporation regarding the election and removal of directors;
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a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders;
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the requirement that a special meeting of stockholders may be called only by the chief executive officer or the president or the board of directors, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors; and
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advance notice procedures that stockholders must comply with in order to nominate candidates to our board of directors or to propose matters to be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquiror from conducting a solicitation of proxies to elect the acquiror’s own slate of directors or otherwise attempting to obtain control of us.
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In addition, these provisions would apply even if we were to receive an offer that some stockholders may consider beneficial.
We are also subject to the anti‑takeover provisions contained in Section 203 of the Delaware General Corporation Law. Under Section 203, a corporation may not, in general, engage in a business combination with any holder of 15% or more of its capital stock unless the holder has held the stock for three years or, among other exceptions, the board of directors has approved the transaction. For a description of our capital stock, see the section titled “Description of Capital Stock.”
Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third‑party claims against us and may reduce the amount of money available to us.
Our amended and restated certificate of incorporation and amended and restated bylaws provide that we will indemnify our directors and officers, in each case to the fullest extent permitted by Delaware law.
In addition, as permitted by Section 145 of the Delaware General Corporation Law, our amended and restated bylaws to be effective immediately prior to the completion of this offering and our indemnification agreements that we have entered into with our directors and officers provide that:
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We will indemnify our directors and officers for serving us in those capacities or for serving other business enterprises at our request, to the fullest extent permitted by Delaware law. Delaware law provides that a corporation may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the registrant and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful.
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We may, in our discretion, indemnify employees and agents in those circumstances where indemnification is permitted by applicable law.
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We are required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except that such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification.
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We will not be obligated pursuant to our amended and restated bylaws to indemnify a person with respect to proceedings initiated by that person against us or our other indemnitees, except with respect to proceedings authorized by our board of directors or brought to enforce a right to indemnification.
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The rights conferred in our amended and restated bylaws are not exclusive, and we are authorized to enter into indemnification agreements with our directors, officers, employees and agents and to obtain insurance to indemnify such persons.
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We may not retroactively amend our amended and restated bylaw provisions to reduce our indemnification obligations to directors, officers, employees and agents.
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Our certificate of incorporation will provide that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Our certificate of incorporation will provide that the Court of Chancery of the State of Delaware is the exclusive forum for any derivative action or proceeding brought on our behalf, any action asserting a breach of fiduciary duty, any action asserting a claim against us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws, any action to interpret, apply, enforce, or determine the validity of our certificate of incorporation or bylaws, or any action asserting a claim against us that is governed by the internal affairs doctrine. The choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and other employees.
Alternatively, if a court were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affect our business and financial condition.
We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.
We do not currently intend to pay any cash dividends on our common stock for the foreseeable future. We currently intend to invest our future earnings, if any, to fund our growth. Therefore, you are not likely to receive any dividends on your common stock for the foreseeable future. Since we do not intend to pay dividends, your ability to receive a return on your investment will depend on any future appreciation in the market value of our common stock. There is no guarantee that our common stock will appreciate or even maintain the price at which our holders have purchased it.
Concentration of ownership of our common stock among our existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions.
Upon the closing of this offering, our executive officers, directors and current beneficial owners of 5% or more of our common stock and their respective affiliates will, in the aggregate, beneficially own
% of our outstanding common stock. As a result, these persons, acting together, would be able to significantly influence all matters requiring stockholder approval, including the election and removal of directors, any merger, consolidation, sale of all or substantially all of our assets, or other significant corporate transactions.
Some of these persons or entities may have interests different than yours. For example, because many of these stockholders purchased their shares at prices substantially below the price at which shares are being sold in this offering and have held their shares for a longer period, they may be more interested in selling our company to an acquirer than other investors, or they may want us to pursue strategies that deviate from the interests of other stockholders.
We are an “emerging growth company” and, as a result of the reduced disclosure and governance requirements applicable to emerging growth companies, our common stock may be less attractive to investors.
We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and we intend to take advantage of some of the exemptions from reporting requirements that are applicable to other public companies that are not emerging growth companies, including:
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being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in this prospectus;
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not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting;
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not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;
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reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and
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not being required to hold a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.
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We cannot predict if investors will find our common stock less attractive because we will 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. We may take advantage of these reporting exemptions until we are no longer an emerging growth company. We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the closing of this offering, (b) in which we have total annual gross revenue of at least $1.07 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by non‑affiliates exceeds $700 million as of the prior June 30th, and (2) the date on which we have issued more than $1.0 billion in non‑convertible debt during the prior three‑year period.
Under Section 107(b) of the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards 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, we will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.
After the closing of this offering, we will be subject to the reporting requirements of the Securities Exchange Act of 1934, the Sarbanes‑Oxley Act and the rules and regulations of the stock market on which our common stock is listed. The Sarbanes‑Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting. Commencing with our fiscal year ending December 31, 2018, we must perform system and process evaluation and testing of our internal control over financial reporting to allow management to report on the effectiveness of our internal control over financial reporting in our Form 10‑K filing for that year, as required by Section 404 of the Sarbanes‑Oxley Act. This will require that we incur substantial additional professional fees and internal costs to expand our accounting and finance functions and that we expend significant management efforts. Prior to this offering, we have never been required to test our internal control within a specified period, and, as a result, we may experience difficulty in meeting these reporting requirements in a timely manner.
We may identify weaknesses in our system of internal financial and accounting controls and procedures that could result in a material misstatement of our financial statements. Our internal control over financial reporting will not prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud will be detected.
If we are not able to comply with the requirements of Section 404 of the Sarbanes‑Oxley Act in a timely manner, or if we are unable to maintain proper and effective internal controls, we may not be able to produce timely and accurate financial statements. If that were to happen, the market price of our stock could decline and we could be subject to sanctions or investigations by the stock exchange on which our common stock is listed, the Securities and Exchange Commission, or SEC, or other regulatory authorities.
We will have broad discretion in the use of proceeds from this offering and may invest or spend the proceeds in ways with which you do not agree and in ways that may not increase the value of your investment.
We will have broad discretion over the use of proceeds from this offering. You may not agree with our decisions, and our use of the proceeds may not yield any return on your investment. We expect to use the net proceeds to us from this offering, together with our existing cash and cash equivalents: (i) to complete our ongoing Phase 2 clinical trials of serlopitant for prutitus associated with atopic dermatitus and psoriasis, and for refractory chronic cough; (ii) to significantly advance our planned Phase 3 development of serlopitant for pruritus associated with prurigo nodularis; (iii) to supply serlopitant for our clinical trials and for the development and validation of our commercial manufacturing process for serlopitant in preparation for our NDA and
Marketing Authorization Application, or MAA
submissions; (iv) for a $3.0 million milestone payment to Merck, associated with initiating a Phase 3 clinical trial; and (v) the remainder for personnel expenses, other development activities, including potentially commencing Phase 3 clinical trials for pruritus associated with atopic dermatitis and psoriasis, and for refractory chronic cough, working capital and other general corporate purposes, including the costs of operating as a public company. See “Use of Proceeds” on page 48 for a more complete description of the intended use of proceeds from this offering. Our failure to apply the net proceeds from this offering effectively could compromise our ability to pursue our growth strategy and we might not be able to yield a significant return, if any, on our investment of these net proceeds. You will not have the opportunity to influence our decisions on how to use our net proceeds from this offering.
We might not be able to utilize a significant portion of our net operating loss carryforwards and research and development tax credit carryforwards.
As of
December 31, 2016
, we had federal and state net operating loss carryforwards of $28.2 million and $15.0 million, respectively. These carryforwards will begin to expire in 2031 for federal and state purposes, if not utilized before they expire. As of
December 31, 2016
, we had federal and state research and development tax credit carryforwards of $0.5 million and $0.4 million, respectively. The federal credits begin to expire in 2031 and the California research credits have no expiration dates. These net operating loss and tax credit carryforwards could expire unused and be unavailable if we do not generate sufficient taxable income prior to
their expiration. In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50 percentage point change, by value, in its equity ownership over a three‑year period, the corporation’s ability to use its pre‑change net operating loss carryforwards and other pre‑change tax attributes to offset its post‑change income or tax liability may be limited. We have not determined if we have experienced Section 382 ownership changes in the past and if a portion of our net operating loss and tax credit carryforwards are subject to an annual limitation under Sections 382 or 383. In addition, we may experience ownership changes in the future as a result of subsequent shifts in our stock ownership, including this offering, some of which may be outside of our control. As a result, even if we earn net taxable income, our ability to use our net operating loss and tax credit carryforwards may be materially limited, which could harm our future operating results by effectively increasing our future tax obligations.
We will incur increased costs and demands upon management as a result of being a public company.
As a public company listed in the United States, we will incur significant additional legal, accounting and other costs. These additional costs could negatively affect our financial results. In addition, changing laws, regulations and standards relating to corporate governance and public disclosure, including regulations implemented by the SEC and The NASDAQ Stock Market, LLC, may increase legal and financial compliance costs and make some activities more time‑consuming. These laws, regulations and standards are subject to varying interpretations and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative expenses and a diversion of management's time and attention from revenue‑generating activities to compliance activities. If notwithstanding our efforts to comply with new laws, regulations and standards, we fail to comply, regulatory authorities may initiate legal proceedings against us and our business may be harmed.
Failure to comply with these rules might also make it more difficult for us to obtain some types of insurance, including director and officer liability insurance, and we might be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. The impact of these events could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, on committees of our board of directors or as members of senior management.
SPECIAL NOTE REGARDING FORWARD‑LOOKING STATEMENTS
This prospectus contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward‑looking statements. In some cases, you can identify forward‑looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward‑looking statements include, but are not limited to, statements about:
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our clinical and regulatory development plans for serlopitant, including the timing of the commencement of, and receipt of results from, our ongoing Phase 2 and planned Phase 3 clinical trials and the timing of our submission of an NDA to the FDA for serlopitant;
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our expectations regarding the potential market size and size of the potential patient populations for serlopitant, if approved or cleared for commercial use;
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the timing of commencement of future non-clinical studies and clinical trials;
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our ability to successfully complete, clinical trials;
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our intentions and our ability to establish collaborations;
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the timing or likelihood of regulatory filings and approvals or clearances for our product candidates;
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our commercialization, marketing and manufacturing capabilities and expectations;
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our intentions with respect to the commercialization of serlopitant or any other candidates;
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the pricing and reimbursement of serlopitant, if approved;
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the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates, including the projected terms of patent protection;
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estimates of our expenses, future revenue, capital requirements, our needs for additional financing and our ability to obtain additional capital;
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our use of proceeds from this offering;
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our future financial performance;
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developments and projections relating to our competitors and our industry, including competing drugs and therapies; and
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other risks and uncertainties, including those listed under the caption “Risk Factors.”
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These forward‑looking statements are based on management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate, and management’s beliefs and assumptions are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all of our forward‑looking statements in this prospectus may turn out to be inaccurate. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under “Risk Factors” and elsewhere in this prospectus. Potential investors are urged to consider these factors carefully in evaluating the forward‑looking statements. These forward‑looking statements speak only as of the date of this prospectus. Except as required by law, we assume no obligation to update or revise these forward‑looking statements for any reason, even if new information becomes available in the future. You should, however, review the factors and risks we describe in the reports we will file from time to time with the SEC after the date of this prospectus. See “Where You Can Find More Information.”
INDUSTRY AND MARKET DATA
This prospectus contains estimates, projections and other information concerning our industry, our business and the markets for our product candidates, including data regarding the estimated patient population and market size for our product candidates prepared by our management. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. In some cases, we do not expressly refer to the sources from which this data is derived. In that regard, when we refer to one or more sources of this type of data in any paragraph, you should assume that other data of this type appearing in the same paragraph is derived from the same sources, unless otherwise expressly stated or the context otherwise requires.
USE OF PROCEEDS
We estimate that the net proceeds from the sale of shares of common stock in this offering will be approximately $ million at an assumed initial public offering price of $ per share (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. If the underwriters exercise their option to purchase additional shares in full, we estimate that net proceeds will be approximately $ million at an assumed initial public offering price of $ per share (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.
Each $1.00 increase (decrease) in the assumed initial public offering price of $ per share (the midpoint of the range set forth on the cover of this prospectus) would increase (decrease) the net proceeds to us from this offering, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $ million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same. We may also increase or decrease the number of shares we are offering. An increase (decrease) of 1,000,000 in the number of shares we are offering would increase (decrease) the net proceeds to us from this offering, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $ million, assuming the assumed initial public offering price stays the same. The pro forma as adjusted information is illustrative only, and we will adjust this information based on the actual initial public offering price and other terms of this offering determined at pricing. We do not expect that a change in the offering price or the number of shares by these amounts would have a material effect on our intended uses of the net proceeds from this offering, although it may impact the amount of time prior to which we may need to seek additional capital.
We currently expect to use our net proceeds from this offering, together with our existing cash, as follows:
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approximately $ million of external clinical costs to complete our ongoing Phase 2 clinical trials of serlopitant for pruritus associated with atopic dermatitis and psoriasis, and for refractory chronic cough;
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approximately $ million of external clinical costs to significantly advance our planned Phase 3 development of serlopitant for pruritus associated with prurigo nodularis;
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approximately $ million of external development and manufacturing costs primarily associated with supplying serlopitant for our clinical trials, and development and validation of our commercial manufacturing process for serlopitant in preparation for our NDA and MAA submissions;
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$3.0 million milestone payment to Merck associated with initiating a Phase 3 clinical trial; and
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the remainder for personnel expenses, other development activities, including potentially commencing Phase 3 clinical trials for pruritus associated with atopic dermatitis and psoriasis and for refractory chronic cough, working capital and other general corporate purposes, including the costs of operating as a public company.
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However, due to the uncertainties inherent in the clinical development and regulatory approval process, it is difficult to estimate with certainty the exact amounts of the net proceeds from this offering that may be used for the above purposes. As such, our management will retain broad discretion over the use of the net proceeds from this offering. The amounts and timing of our expenditures will depend upon numerous factors, including (i) the time and cost necessary to advance serlopitant through our ongoing and planned non-clinical studies and clinical trials; (ii) our ability to obtain regulatory approval or clearance for and subsequently commercialize our product candidates; and (iii) the time and cost necessary to develop non-clinical and clinical supplies and a commercial‑scale manufacturing process for product candidates, as well as the infrastructure to commercialize our product candidates.
We believe that our existing cash, together with the net proceeds from this offering, will be sufficient to fund our planned operations through , enabling us to complete our three ongoing Phase 2 clinical trials and to significantly advance our planned Phase 3 clinical trials and our NDA and MAA preparations. Following this
offering, we will require substantial capital to complete clinical development, seek regulatory approval of, and, if approved, commercialize, serlopitant. We
may seek additional funds through public or private equity, debt financings or other sources, including strategic collaborations.
For additional information regarding our potential capital requirements, see “Risks Related to Our Financial Position and Capital Needs” under the heading “Risk Factors.”
Pending the use of the proceeds from this offering, we intend to invest the net proceeds in interest‑bearing, investment‑grade securities, certificates of deposit, or government securities.
DIVIDEND POLICY
We have never declared or paid cash dividends on our capital stock. We intend to retain all available funds and any future earnings, if any, to fund the development and expansion of our business and we do not anticipate paying any cash dividends in the foreseeable future. Any future determination related to dividend policy will be made at the discretion of our board of directors.
CAPITALIZATION
The following table sets forth our cash, cash equivalents and investments and capitalization as of September 30, 2017:
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on a pro forma basis to give effect to:
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the automatic conversion of all shares of our convertible preferred stock outstanding into an aggregate of 25,975,346 shares of our common stock, which conversion will be effective immediately prior to the closing of this offering; and
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the filing and effectiveness of our amended and restated certificate of incorporation, which will occur immediately prior to the closing of this offering; and
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on a pro forma as adjusted basis to give further effect to the sale of shares of common stock in this offering at an assumed initial public offering price of $ per share (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.
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You should read this information together with our financial statements and related notes appearing elsewhere in this prospectus and the information set forth under the headings “Selected Financial Data” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”
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September 30, 2017
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Actual
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Pro Forma
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Pro
Forma, as
Adjusted
(1)
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(in thousands, except share and per
share data)
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Cash, cash equivalents and investments
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$
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73,547
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$
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73,547
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$
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Convertible preferred stock, par value $0.001 per share: 28,322,761 shares authorized, 25,975,346 shares issued and outstanding at September 30, 2017; no shares authorized, issued and outstanding, pro forma and pro forma as adjusted
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109,330
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—
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—
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Preferred stock, $0.0001 par value per share; no shares authorized, issued and outstanding, actual; 20,000,000 shares authorized, no shares issued and outstanding, pro forma and pro forma as adjusted
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—
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—
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—
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Common stock, $0.0001 par value per share: 55,000,000 shares authorized, 14,292,980 shares issued and outstanding at September 30, 2017; 300,000,000 shares authorized, 40,268,326 shares issued and outstanding, pro forma; and 300,000,000 shares authorized, shares issued and outstanding, pro forma as adjusted
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1
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4
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Additional paid‑in capital
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1,968
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111,295
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Accumulated other comprehensive income
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(15
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(15
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Accumulated deficit
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(49,915
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)
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(49,915
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)
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Total stockholders’ (deficit) equity
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(47,961
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)
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61,369
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Total capitalization
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$
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61,369
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$
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61,369
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$
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(1)
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A $1.00 increase (decrease) in the assumed initial public offering price of $ per share (the midpoint of the range set forth on the cover of this prospectus) would increase (decrease) the amount of cash, cash equivalents and
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investments, additional paid‑in capital, total stockholders’ (deficit) equity and total capitalization by approximately $ , assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase (decrease) of 1,000,000 shares in the number of shares offered by us would increase (decrease) cash, cash equivalents and investments, additional paid‑in capital, total stockholders’ (deficit) equity and total capitalization by approximately $ , assuming the assumed initial public offering price of $ per share (the midpoint of the range set forth on the cover of this prospectus) remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. The pro forma as adjusted information discussed above is illustrative only and will be adjusted based on the actual public offering price and other terms of this offering determined at pricing.
The outstanding share information in the table above excludes the following:
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5,807,569 shares of common stock issuable upon the exercise of outstanding stock options as of September 30, 2017 having a weighted‑average exercise price of $1.07 per share;
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665,606 shares of common stock reserved for issuance pursuant to future awards under our 2011 Stock Incentive Plan as of September 30, 2017, which will no longer be available for issuance effective on the day prior to the first public trading date of our common stock;
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shares of common stock to be reserved for issuance pursuant to future awards under our 2018 Omnibus Incentive Plan, as well as any automatic increases in the number of shares of our common stock reserved for future issuance under this plan, which will become effective on the day prior to the first public trading date of our common stock; and
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shares of common stock to be reserved for issuance pursuant to our 2018 Employee Stock Purchase Plan, as well as any automatic increases in the number of shares of our common stock reserved for future issuance under this plan, which will become effective on the day prior to the first public trading date of our common stock.
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DILUTION
If you invest in our common stock in this offering, your interest will be immediately diluted to the extent of the difference between the initial public offering price per share of our common stock in this offering and the net tangible book value per share of our common stock after this offering. As of September 30, 2017, we had a historical net tangible book value of
$61.4 million
, or
$4.29
per share of common stock. Our net tangible book value represents total tangible assets less total liabilities all divided by the number of shares of common stock outstanding on September 30, 2017. Our pro forma net tangible book value as of September 30, 2017, before giving effect to this offering, was
$61.4 million
, or
$1.52
per share of our common stock. Pro forma net tangible book value, before the issuance and sale of shares in this offering and gives effect to the conversion of all shares of our convertible preferred stock outstanding at September 30, 2017, which will be effective immediately prior to the closing of this offering.
After giving effect to the sale of shares of common stock in this offering at an assumed initial public offering price of $ 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, our pro forma as adjusted net tangible book value as of September 30, 2017 would have been approximately $ million, or $ per share. This represents an immediate increase in pro forma as adjusted net tangible book value of $ per share to existing stockholders and an immediate dilution of $ per share to new investors. The following table illustrates this per share dilution:
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Assumed initial public offering price per share
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$
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Historical net tangible book value per share as of September 30, 2017
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$
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4.29
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Pro forma decrease in net tangible book value per share
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(2.77
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)
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Pro forma net tangible book value per share as of September 30, 2017
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$
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1.52
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Increase in pro forma net tangible book value per share attributable to new investors
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Pro forma as adjusted net tangible book value per share after this offering
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Dilution per share to new investors participating in this offering
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|
A $1.00 increase (decrease) in the assumed initial public offering price of $ per share (the midpoint of the range set forth on the cover of this prospectus) would increase (decrease) our pro forma as adjusted net tangible book value as of September 30, 2017 after this offering by approximately $ million, or approximately $ per share, and would decrease (increase) dilution to investors in this offering by approximately $ per share, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of shares we are offering. Assuming the assumed initial public price per share remains the same, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, an increase of 1,000,000 in the number of shares we are offering would increase our pro forma as adjusted net tangible book value as of September 30, 2017 after this offering by approximately $ million, or approximately $ per share, and would decrease dilution to investors in this offering by approximately $ per share, and a decrease of 1,000,000 in the number of shares we are offering would decrease our pro forma as adjusted net tangible book value as of September 30, 2017 after this offering by approximately $ million, or approximately $ per share, and would increase dilution to investors in this offering by approximately $ per share. The pro forma as adjusted information is illustrative only, and we will adjust this information based on the actual initial public offering price and other terms of this offering determined at pricing.
If the underwriters fully exercise their option to purchase additional shares, pro forma as adjusted net tangible book value after this offering would increase to approximately $ per share, and there would be an immediate dilution of approximately $ per share to new investors.
To the extent that outstanding options with an exercise price per share that is less than the pro forma as adjusted net tangible book value per share are exercised, new investors will experience further dilution. In addition, we may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.
The following table shows, as of September 30, 2017, on a pro forma as adjusted basis, the number of shares of common stock purchased from us, the total consideration paid to us and the average price paid per share by existing stockholders and by new investors purchasing common stock in this offering at an assumed initial public offering price of $ per share (the midpoint of the range set forth on the cover of this prospectus), before deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us (in thousands, except share and per share amounts and percentages):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares Purchased
|
|
Total Consideration
|
|
Average
Price Per
Share
|
|
Number
|
|
Percent
|
|
Amount
|
|
Percent
|
|
Existing stockholders
|
40,268,326
|
|
|
|
|
$
|
109,940
|
|
|
|
|
$
|
2.73
|
|
Investors participating in this offering
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
100
|
%
|
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
If the underwriters exercise their option to purchase additional shares in full, the number of shares of common stock held by existing stockholders will be reduced to % of the total number of shares of common stock to be outstanding after this offering, and the number of shares of common stock held by investors participating in this offering will be further increased to % of the total number of shares of common stock to be outstanding after this offering.
The number of shares of common stock to be outstanding after this offering is based on the number of shares outstanding as of September 30, 2017 and excludes the following:
|
|
▪
|
5,807,569 shares of common stock issuable upon the exercise of outstanding stock options as of September 30, 2017 having a weighted‑average exercise price of $1.07 per share;
|
|
|
▪
|
665,606 shares of common stock reserved for issuance pursuant to future awards under our 2011 Stock Incentive Plan as of September 30, 2017, which will no longer be available for issuance effective on the day prior to the first public trading date of our common stock;
|
|
|
▪
|
shares of common stock to be reserved for issuance pursuant to future awards under our 2018 Omnibus Incentive Plan, as well as any automatic increases in the number of shares of our common stock reserved for future issuance under this plan, which will become effective on the day prior to the first public trading date of our common stock; and
|
|
|
▪
|
shares of common stock to be reserved for issuance pursuant to our 2018 Employee Stock Purchase Plan, as well as any automatic increases in the number of shares of our common stock reserved for future issuance under this plan, which will become effective on the day prior to the first public trading date of our common stock.
|
SELECTED FINANCIAL DATA
The following tables set forth a summary of our historical financial data as of and for the periods indicated. We have derived the selected statements of operations data for the years ended December 31, 2015 and 2016 from our audited financial statements included elsewhere in this prospectus. We have derived the selected statements of operations data for the nine months ended
September 30, 2016
and
2017
, and the selected balance sheet data as of
September 30, 2017
, from our unaudited interim financial statements included elsewhere in this prospectus. We have prepared the unaudited interim financial statements on the same basis as the audited financial statements and have included, in our opinion, all adjustments, consisting only of normal recurring adjustments that we consider necessary for a fair statement of the financial information set forth in those statements. You should read this data together with our financial statements and related notes appearing elsewhere in this prospectus and the information under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” The summary financial data included in this section are not intended to replace the financial statements and related notes included elsewhere in this prospectus. Our historical results are not necessarily indicative of our future results, and our interim results for the
nine
months ended
September 30, 2017
are not necessarily indicative of results to be expected for the full year ending December 31, 2017, or any other period.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
Nine Months Ended September 30,
|
|
|
2015
|
|
2016
|
|
2016
|
|
2017
|
|
|
(in thousands, except share and per share numbers)
|
Statements of Operations Data:
|
|
|
|
|
|
|
|
|
Collaboration and license revenue
|
|
$
|
—
|
|
|
$
|
674
|
|
|
$
|
224
|
|
|
$
|
1,807
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Research and development
|
|
2,921
|
|
|
11,255
|
|
|
7,178
|
|
|
18,461
|
|
General and administrative
|
|
1,687
|
|
|
3,751
|
|
|
2,453
|
|
|
3,462
|
|
Total operating expenses
|
|
4,608
|
|
|
15,006
|
|
|
9,631
|
|
|
21,923
|
|
Loss from operations
|
|
(4,608
|
)
|
|
(14,332
|
)
|
|
(9,407
|
)
|
|
(20,116
|
)
|
Interest income and other expenses, net
|
|
—
|
|
|
264
|
|
|
176
|
|
|
316
|
|
Net loss attributable to common stockholders
|
|
$
|
(4,608
|
)
|
|
$
|
(14,068
|
)
|
|
$
|
(9,231
|
)
|
|
$
|
(19,800
|
)
|
Net loss attributable to common stockholder per share, basic and diluted
(1)
|
|
$
|
(0.36
|
)
|
|
$
|
(1.05
|
)
|
|
$
|
(0.69
|
)
|
|
$
|
(1.44
|
)
|
Weighted-average number of common shares used to compute basic and diluted net loss per share
(1)
|
|
12,772.388
|
|
|
13,429.823
|
|
|
13,370,809
|
|
|
13,720,985
|
|
Pro forma net loss per share attributable to common stockholders, basic and diluted (unaudited)
(2)
|
|
|
|
$
|
(0.51
|
)
|
|
|
|
$
|
(0.64
|
)
|
Pro forma weighted‑average number of common shares outstanding, basic and diluted (unaudited)
(2)
|
|
|
|
27,550,706
|
|
|
|
|
31,108,477
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
See notes to our financial statements included elsewhere in this prospectus for an explanation of the calculations of our net loss per share, basic and diluted and the weighted‑average number of shares used in the computation of the per share amounts.
|
|
|
(2)
|
The pro forma net loss per share, attributable to common stockholders basic and diluted, and the pro forma weighted‑average number of common shares outstanding, basic and diluted, data is computed using the
|
weighted‑average number of shares of common stock outstanding, after giving effect to the conversion of all the outstanding shares of our convertible preferred stock into an aggregate of 25,975,346 shares of our common stock, which will occur immediately prior to the completion of this offering, as if such transaction had occurred on
September 30, 2017
. The pro forma net loss per share of common stock, basic and diluted, and the pro forma weighted‑average number of common shares outstanding, basic and diluted, does not give effect to the issuance of shares from the proposed initial public offering nor do they give effect to potential dilutive securities where the impact would be anti‑dilutive. See Note 9 to our audited financial statements included elsewhere in this prospectus.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
September 30,
|
|
|
2015
|
|
2016
|
|
2017
|
|
|
(in thousands)
|
Balance Sheet Data:
|
|
|
|
|
|
|
Cash, cash equivalents and investments
|
|
$
|
43,808
|
|
|
$
|
41,328
|
|
|
$
|
73,547
|
|
Working capital
|
|
43,115
|
|
|
27,637
|
|
|
68,560
|
|
Total assets
|
|
43,885
|
|
|
42,053
|
|
|
75,800
|
|
Convertible preferred stock
|
|
59,003
|
|
|
59,003
|
|
|
109,330
|
|
Accumulated deficit
|
|
(16,047
|
)
|
|
(30,115
|
)
|
|
(49,915
|
)
|
Total stockholders’ deficit
|
|
(15,953
|
)
|
|
(29,441
|
)
|
|
(47,961
|
)
|
|
|
|
|
|
|
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together with the section of this prospectus entitled “Selected Financial Data” and our financial statements and related notes included elsewhere in this prospectus. This discussion and other parts of this prospectus contain forward‑looking statements that involve risk and uncertainties, such as statements of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these forward‑looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section of this prospectus entitled “Risk Factors.”
Overview
We are a late‑stage biopharmaceutical company focused on the development and commercialization of serlopitant for the treatment of pruritus associated with dermatologic conditions such as atopic dermatitis, psoriasis and prurigo nodularis. We are concurrently evaluating the use of serlopitant for the treatment of refractory chronic cough.
We believe that serlopitant, a highly selective small molecule inhibitor of the neurokinin 1 receptor, or NK
1
‑R, has the potential to significantly alleviate pruritus and refractory chronic cough symptoms.
Since commencing operations in 2011, we have devoted substantially all of our efforts and financial resources to the clinical development of serlopitant. We have not generated any revenue from product sales and, as a result, we have never been profitable and have incurred net losses in each year since commencement of our operations. As of
December 31, 2016
and
September 30, 2017
, we had accumulated deficits of
$30.1 million
and
$49.9 million
, respectively, primarily as a result of research and development and general and administrative expenses. We incurred net losses of approximately
$4.6 million
,
$14.1 million
and
$19.8 million
in the years ended
December 31, 2015
and 2016 and the nine months ended
September 30, 2017
, respectively. We do not expect to generate product revenue unless and until we obtain marketing approval for and commercialize serlopitant for the treatment of pruritus associated with one or more dermatologic conditions or for refractory chronic cough, and we can provide no assurance that we will ever generate significant revenue or profits.
To date, we have financed our operations primarily through private placements of convertible preferred stock, from which we have received net proceeds of
$109.3 million
through
September 30, 2017
, including gross proceeds of $50.5 million from the sale of Series C convertible preferred stock in July 2017, and from an upfront, non‑refundable payment of $11.0 million under our August 2016 license and collaboration agreement with Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd., together referred to as JT Torii, which we refer to as the Collaboration Agreement.
As of
September 30, 2017
, our cash and cash equivalents and investments totaled
$73.5 million
. We believe that our existing cash, cash equivalents and investments will be sufficient to fund our planned operations for at least the next twelve months. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. See “— Liquidity and Capital Resources.”
We expect to incur substantial expenditures in the foreseeable future as we advance serlopitant through clinical development, the regulatory approval process and, if approved, commercial launch activities. Specifically, in the near term, we expect to incur substantial expenses relating to our ongoing Phase 2 and planned Phase 3 clinical trials, the development and validation of our commercial manufacturing process for serlopitant, and other development activities including potentially commencing Phase 3 clinical trials for pruritus associated with atopic dermatitis and psoriasis, and for refractory chronic cough. In addition, we expect to pay a $3.0 million milestone payment to Merck upon the initiation of our Phase 3 clinical trials for pruritus associated with prurigo nodularis. Furthermore, upon the closing of this offering, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses that we did not incur as a private company.
We will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from sales of serlopitant, if ever, we expect to finance
our operations through the sale of equity, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back, or discontinue the development and commercialization of serlopitant for one or more indications or delay our efforts to expand our product pipeline.
Components of Operating Results
Revenue
We have not generated any revenue from the sale of products since our inception and do not expect to generate any revenue from the sale of products in the near future.
Collaboration and License Revenue
We recognize revenue pursuant to the Collaboration Agreement and our services agreement with JT Torii in connection with the clinical development and commercialization of products covered by the collaboration,
including non-refundable upfront license fees, contingent consideration payments based on the achievement of defined collaboration milestones and royalties on sales of commercialized products.
Under the Collaboration Agreement, we granted to JT Torii the right to develop and commercialize products containing serlopitant in Japan, for the treatment of diseases and conditions other than nausea or vomiting. In exchange, JT Torii paid us an upfront, non‑refundable payment of
$11.0 million
in August 2016. In addition, we are entitled to receive aggregate payments of up to
$28.0 million
upon the achievement of specified development and regulatory milestones, and
$15.0 million
upon the achievement of a commercial milestone, as well as tiered royalties from the mid-single digits up to the mid‑teens on sales of licensed products in Japan.
Revenue from the upfront payment is being amortized over the period of performance of the Collaboration Agreement, the period which we expect to provide research and development services to JT Torii.
On September 1, 2017, we entered into a new services agreement with JT Torii to provide research and development services, including regulatory, chemistry and manufacturing support and related materials, that is distinct from the original Collaboration Agreement. We evaluated the new services agreement and determined that the research and materials delivered to JT Torii represent a separate earnings process that provides stand alone value to JT Torii. The fees received under the services agreement are recognized as and when such services are performed by us and JT Torii consumes the benefits of those services. We have no obligation to provide services unless requested by JT Torii and agreed to by us. We are eligible to receive reimbursement of estimated costs incurred, and payment for research services performed directly by us, at agreed upon rates.
Operating Expenses
Research and Development Expenses
Substantially all of our research and development expenses consist of expenses incurred in connection with the development of serlopitant. These expenses include certain payroll and personnel expenses including stock‑based compensation, consulting costs, contract manufacturing costs and fees paid to clinical research organizations or CROs to conduct certain research and development activities on our behalf.
We do not allocate our costs by each indication for which we are developing serlopitant, as a significant amount of our development activities broadly support all indications. In addition, several of our departments support our serlopitant drug candidate development program and we do not identify internal costs for each potential indication.
We do not separately track costs incurred in connection with our agreements with JT Torii, which are also included in research and development expenses. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized and recognized as an expense as the goods are delivered or the related services are performed.
We expense both internal and external research and development expenses as they are incurred. We are focusing substantially all of our resources and development efforts on the development of serlopitant. We expect our research and development expenses to increase during the next few years as we seek to complete our clinical program, pursue regulatory approval of serlopitant in the United States and prepare for a possible commercial launch of serlopitant. Predicting the timing or the final cost to complete our clinical program or validation of our commercial manufacturing and supply processes is difficult and delays may occur because of many factors,
including factors outside of our control. For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate, or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development. Furthermore, we are unable to predict when or if serlopitant will receive regulatory approval in the United States with any certainty.
General and Administrative Expenses
General and administrative expenses consist principally of personnel‑related costs, including stock‑based compensation, for personnel in executive, finance, business and corporate development, and other administrative functions, professional fees for legal, consulting, accounting services, rent and other general operating expenses not otherwise classified as research and development expenses.
We anticipate that our general and administrative expenses will increase as a result of increased personnel costs, including stock‑based compensation, expanded infrastructure and higher consulting, legal and accounting services associated with maintaining compliance with stock exchange listing and SEC requirements, investor relations costs and director and officer insurance premiums associated with being a public company.
Interest Income and Other Expense, Net
Interest income consists primarily of interest earned on our investments in corporate notes and government agency notes.
Results of Operations
Comparison of the Nine Months Ended September 30, 2016 and 2017
The following table summarizes our results of operations for the periods indicated (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30,
|
|
Increase
|
|
% Change
|
|
|
2016
|
|
2017
|
|
|
Collaboration and license revenue
|
|
$
|
224
|
|
|
$
|
1,807
|
|
|
$
|
1,583
|
|
|
*
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
7,178
|
|
|
18,461
|
|
|
11,283
|
|
|
157
|
General and administrative
|
|
2,453
|
|
|
3,462
|
|
|
1,009
|
|
|
41
|
Loss from operations
|
|
(9,407
|
)
|
|
(20,116
|
)
|
|
(10,709
|
)
|
|
114
|
Interest income and other expense, net
|
|
176
|
|
|
316
|
|
|
140
|
|
|
80
|
Net loss
|
|
$
|
(9,231
|
)
|
|
$
|
(19,800
|
)
|
|
$
|
(10,569
|
)
|
|
114
|
|
|
|
|
|
|
|
|
|
Collaboration and License Revenue
Collaboration and license revenue of
$1.8 million
for the nine months ended September 30, 2017 was primarily due to the allocation of revenue we recognized during the period from the initial upfront payment of
$11.0 million
under the Collaboration Agreement with JT Torii we entered into in August 2016, as well as additional revenue of $0.5 million from JT Torii for development support services recognized by us during the period. We had collaboration and license revenue of $0.2 million for the nine months ended September 30, 2016 related to two months of revenue that we recognized from the $11.0 million upfront payment under the Collaboration Agreement.
Research and Development Expenses
Research and development expenses increased
$11.3 million
, or
157%
, from
$7.2 million
for the nine months ended September 30, 2016 to
$18.5 million
for the nine months ended September 30, 2017. The increase was primarily due to an increase in clinical trial expenses of $6.9 million, an increase in personnel expenses of $1.8 million as a result of an increase in our employee headcount, as well as an increase of $2.4 million in consulting expenses and professional fees. For the periods presented, substantially all of our research and development expenses related to our development activity for serlopitant.
General and Administrative Expenses
General and administrative expenses increased
$1.0 million
, or
41%
, from
$2.5 million
for the nine months ended September 30, 2016 to
$3.5 million
for the nine months ended September 30, 2017. The increase was primarily due to increases in consulting expenses and professional fees of $0.7 million and personnel expenses of $0.3 million as we expanded our operations.
Interest Income and Other Expense, Net
Interest income and other expense, net was
$0.2 million
and
$0.3 million
for the nine months ended
September 30, 2016
and 2017, respectively, which related to interest earned on our outstanding investment balances.
Comparison of the Years Ended December 31, 2015 and 2016
The following table summarizes our results of operations for the periods indicated (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended
December 31,
|
|
Increase
|
|
% change
|
|
|
2015
|
|
2016
|
|
|
Collaboration and license revenue
|
|
$
|
—
|
|
|
$
|
674
|
|
|
$
|
674
|
|
|
*
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
2,921
|
|
|
11,255
|
|
|
8,334
|
|
|
285
|
General and administrative
|
|
1,687
|
|
|
3,751
|
|
|
2,064
|
|
|
122
|
Loss from operations
|
|
(4,608
|
)
|
|
(14,332
|
)
|
|
(9,724
|
)
|
|
211
|
Interest income and other expense, net
|
|
—
|
|
|
264
|
|
|
264
|
|
|
*
|
Net loss
|
|
$
|
(4,608
|
)
|
|
$
|
(14,068
|
)
|
|
$
|
(9,460
|
)
|
|
205
|
|
|
|
|
|
|
|
|
|
Collaboration and License Revenue
Collaboration and license revenue of
$0.7 million
for the year ended December 31, 2016 was entirely due to the allocation of revenue we recognized during the period from the initial upfront payment of $11.0 million under the Collaboration Agreement with JT Torii we entered into in August 2016. We had no collaboration and license revenue for the year ended
December 31, 2015
.
Research and Development Expenses
Research and development expenses increased
$8.3 million
, or
285%
, from
$2.9 million
for the year ended
December 31, 2015
to
$11.3 million
for the year ended
December 31, 2016
. The increase was primarily due to a $5.2 million increase in clinical trial costs, an increase of $1.5 million in personnel expenses
as a result of an increase in our employee headcount
, and a $1.2 million increase in consulting expenses and professional fees. For the years ended December 31, 2015 and 2016, substantially all of our research and development expenses related to our
development activity for
serlopitant.
General and Administrative Expenses
General and administrative expenses increased
$2.1 million
, or
122%
, from
$1.7 million
for the year ended
December 31, 2015
to
$3.8 million
for the year ended
December 31, 2016
. The increase was primarily due to an increase in personnel expenses of $1.0 million and an increase in consulting expenses and professional fees of $0.9 million incurred as we expanded our operations.
Interest Income and Other Expense, Net
Interest income
and other expense, net
was
$0.3 million
for the year ended December 31, 2016, which related to interest earned on our outstanding investment balances. We had no interest income and other expense, net for the year ended
December 31, 2015
.
Liquidity and Capital Resources
To date, we have financed our operations primarily through private placements of convertible preferred stock and from a payment under the Collaboration Agreement. We received net proceeds of
$109.3 million
from the sale and issuance of preferred stock through
September 30, 2017
, including $50.5 million received from the sale of our Series C convertible preferred stock in July 2017. In August 2016, we received an upfront, non-refundable payment of
$11.0 million
from JT Torii in connection with the entry into the Collaboration Agreement.
As of
September 30, 2017
, we had cash, cash equivalents and investments of
$73.5 million
.
Our cash, cash equivalents and investments are held in money market accounts and investments in corporate notes and government notes.
We expect to incur substantial expenditures in the foreseeable future as we advance serlopitant through clinical development, the regulatory approval process and, if approved, commercial launch activities. Specifically, in the near term, we expect to incur substantial expenses relating to our ongoing Phase 2 and planned Phase 3 clinical trials, the development and validation of our commercial manufacturing process for serlopitant, and other development activities including potentially commencing Phase 3 clinical trials for pruritus associated with atopic dermatitis and psoriasis and for refractory chronic cough. In addition, we expect to pay a $3.0 million milestone payment to Merck upon the initiation of our Phase 3 clinical trials for pruritus associated with prurigo nodularis. Furthermore, upon the closing of this offering, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses that we did not incur as a private company.
We will continue to require additional capital to develop our product candidate and fund operations for the foreseeable future. We may seek to raise capital through private or public equity or debt financings, collaborative or other arrangements with corporate sources, or through other sources of financing. Adequate additional funding may not be available to us on acceptable terms or at all. Our failure to raise capital as and when needed could have a negative impact on our financial condition and our ability to pursue our business strategies. We anticipate that we will need to raise substantial additional capital, the requirements of which will depend on many factors, including:
|
|
▪
|
the time and cost necessary to complete our ongoing Phase 2 clinical trials for pruritus associated with atopic dermatitis and psoriasis and for refractory chronic cough, our planned Phase 3 clinical trials for pruritus associated with prurigo nodularis as well as any additional current and planned clinical trials of serlopitant;
|
|
|
▪
|
the number, size and type of any additional clinical trials or studies we may choose to initiate or that we may be required to complete prior to obtaining regulatory approval of serlopitant;
|
|
|
▪
|
the timing of, and costs involved in, seeking and obtaining approvals from the FDA and comparable foreign regulatory authorities, including the potential by the FDA or comparable regulatory authorities to require that we perform more studies than those that we current expect
, and the costs of post‑marketing studies that could be required by regulatory authorities;
|
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▪
|
our ability to receive payments under our collaboration with JT Torii, and the timing of receipt of any such payments;
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▪
|
the timing of the milestone payments we must make to Merck;
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▪
|
the costs of preparing to manufacture serlopitant on a commercial scale;
|
|
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▪
|
our ability to successfully commercialize serlopitant;
|
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|
▪
|
the manufacturing, selling and marketing costs associated with serlopitant, including the cost and timing of forming and expanding our sales organization and marketing capabilities;
|
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▪
|
the degree and rate of market acceptance of any products launched by us or our partners;
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▪
|
the cash requirements of any future acquisitions or discovery of product candidates;
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▪
|
the progress, timing, scope and costs of our non-clinical studies and clinical trials, including the ability to enroll patients in a timely manner for potential future clinical trials;
|
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▪
|
the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
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▪
|
our need and ability to hire additional personnel;
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▪
|
our ability to enter into additional collaboration, licensing, commercialization or other arrangements and the terms and timing of such arrangements; and
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▪
|
the emergence of competing technologies or other adverse market developments.
|
If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments and engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. If we are unable to raise additional funds when needed, we may be required to delay, reduce, or terminate some or all of our development programs and clinical trials. We may also be required to sell or license to others rights to serlopitant in certain territories or indications that we would prefer to develop and commercialize ourselves.
See “Risk Factors” for additional risks associated with our substantial capital requirements.
Summary Statement of Cash Flows
The following table sets forth the primary sources and uses of cash for each of the periods presented below (in thousands):
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|
|
Year Ended
December 31,
|
|
Nine Months
Ended September 30,
|
|
|
2015
|
|
2016
|
|
2016
|
|
2017
|
Net cash (used in) provided by:
|
|
|
|
|
|
|
|
|
Operating activities
|
|
$
|
(4,183
|
)
|
|
$
|
(2,291
|
)
|
|
$
|
2,258
|
|
|
$
|
(18,054
|
)
|
Investing activities
|
|
—
|
|
|
(37,490
|
)
|
|
(38,646
|
)
|
|
(21,376
|
)
|
Financing activities
|
|
47,718
|
|
|
—
|
|
|
—
|
|
|
50,361
|
|
Net increase (decrease) in cash
|
|
$
|
43,535
|
|
|
$
|
(39,781
|
)
|
|
$
|
(36,388
|
)
|
|
$
|
10,931
|
|
|
|
|
|
|
|
|
|
|
Cash Provided By (Used In) Operating Activities
Cash provided by operating activities for the
nine
months ended
September 30, 2016
was
$2.3 million
compared to cash used in operations of
$18.1 million
for the
nine
months ended
September 30, 2017
. Cash provided by operating activities in the
nine
months ended
September 30, 2016
was primarily due to changes in
operating assets and liabilities, including an increase in deferred revenue of $10.8 million and an increase in accounts payable and accrued liabilities of $0.9 million, which were partially offset by the net loss for the period of $9.2 million. The cash used in operating activities in the
nine
months ended
September 30, 2017
was primarily due to the net loss for the period of
$19.8 million
as well as non‑cash stock‑based compensation expense of
$1.2 million
, and was also affected by changes in operating assets and liabilities, including a decrease of
$1.3 million
in deferred revenue, an increase in prepaid expenses of $1.1 million and an increase in accounts receivable of $0.5 million, offset by an increase in accounts payable and accrued liabilities of
$3.3 million
.
Cash used in operating activities was
$4.2 million
for the year ended
December 31, 2015
and cash used in operating activities was
$2.3 million
for the year ended
December 31, 2016
. Cash used in operating activities in 2015 was primarily due to the use of funds in our operations related to the development of serlopitant and the resulting net loss of
$4.6 million
, offset by a decrease in accrued expenses of
$0.3 million
. Cash used in operating activities in 2016 was primarily due an increase of
$10.3 million
in deferred revenue associated with the upfront cash payment received in August 2016 in connection with the Collaboration Agreement, non‑cash stock‑based compensation expense of
$0.6 million
, offset by use of funds in our operations that resulted in a net loss of
$14.1 million
, as well as changes in other operating assets and liabilities, including an increase of
$0.6 million
in prepaid expenses and an increase in accounts payable and accrued liabilities of $1.4 million.
Cash Used in Investing Activities
Cash used in investing activities for the
nine
months ended
September 30, 2016
represented purchases of investments of
$49.5 million
, offset by proceeds received from maturities and sales of investments of
$10.9 million
. Cash used in investing activities for the
nine
months ended
September 30, 2017
represented purchases of investments of
$59.2 million
, offset by proceeds received from maturities and sales of investments of
$37.8 million
.
Cash used in investing activities for the year ended
December 31, 2016
represented purchases of investments of
$55.3 million
, offset by proceeds from maturities and sales of investments of
$17.9 million
. We had no cash used in investing activities for the year ended
December 31, 2015
.
Cash Provided by Financing Activities
Cash provided by financing activities was $0 for the nine months ended September 30, 2016. During the nine months ended September 30, 2017 cash provided by financing activities was $50.4 million, consisting primarily of net proceeds from the sale of Series C convertible preferred stock.
Cash provided by financing activities was
$47.7 million
for the year ended December 31, 2015 consisted primarily of net proceeds from the issuance of Series A and Series B convertible preferred stock. We had no cash provided by financing activities for the year ended
December 31, 2016
.
Contractual Obligations and Commitments
The following table summarizes our contractual obligations as of December 31, 2016 (in thousands):
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments due by period
|
|
|
Less than
1 year
|
|
1 to 3
years
|
|
4 to 5
years
|
|
After 5
years
|
|
Total
|
Lease obligations, net
|
|
$
|
244
|
|
|
$
|
124
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
368
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2016, we have lease obligations consisting of an operating lease for our operating facility for approximately 4,000 square feet, which we executed in April 2016. The term of the lease commenced in May 2016 and expires in June 2018. In September 2017, we entered into a new operating facility lease in Redwood City, California for 13,904 square feet, with a term from October 2017 to March 2020. The monthly lease payments under the new lease are approximately $55,000, with annual increases.
In December 2012, we entered into an exclusive worldwide royalty‑free license agreement with Merck for exclusive worldwide rights for the development and commercialization of serlopitant and two other NK
1
‑R antagonists in all human diseases, disorders or conditions, except for the treatment and prevention of nausea or vomiting. We have agreed to make aggregate payments of up to $25.0 million dollars upon the achievement of specified development and regulatory milestones for serlopitant. However, because the achievement of these milestones is not fixed and determinable, such commitments have not been included on our balance sheet or in the Contractual Obligations and Commitments table above. In the near term, upon dosing our first patient in our Phase 3 clinical trials for serlopitant
for the treatment of pruritus associated with prurigo nodularis
, we will be obligated to make a milestone payment of $3.0 million to Merck pursuant to our license agreement, which we anticipate paying from our existing cash resources. For additional information regarding future payments to third parties, including milestone and royalty payments to Merck, please see “Business—Commercial Agreements.”
We enter into contracts in the normal course of business with CROs for clinical trials, non‑clinical studies and testing, manufacturing and other services and products for operating purposes. These contracts generally provide for termination upon notice, and therefore we believe that our non‑cancelable obligations under these agreements are not material.
Critical Accounting Policies, Significant Judgments and Use of Estimates
Our financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or 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 incurred during the reporting periods. Our estimates are based on our 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. Actual results may differ from these estimates under different assumptions or conditions. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
While our significant accounting policies are described in the Notes to our financial statements, we believe that the following critical accounting policies are most important to understanding and evaluating our reported financial results.
Revenue Recognition
To date, our clinical drug candidate, serlopitant, has not been approved for sale by the FDA and we have not generated any revenue from the sale of products. We generate revenue pursuant to the Collaboration Agreement and our services agreement with JT Torii in connection with the clinical development and commercialization of products covered by these agreements.
On August 10, 2016, we entered into the Collaboration Agreement with JT Torii. Under the Collaboration Agreement, we granted to JT Torii the rights to develop and commercialize products containing serlopitant in Japan, for the treatment of diseases and conditions other than nausea or vomiting. In exchange, JT Torii paid us an upfront, non‑refundable payment of $11.0 million. In addition, we are entitled to receive aggregate payments of up to $28.0 million upon the achievement of specified development and regulatory milestones, and $15.0 million upon the achievement of a commercial milestone, as well as tiered royalties from the mid-single digits up to the mid‑teens on sales of licensed products in Japan. Our performance obligations under the license agreement include the transfer of intellectual property rights in the form of licenses, obligations to participate on certain development and/or commercialization committees with the collaboration partners and supply manufactured drug product for clinical trials.
We recognize revenue pursuant to the Collaboration Agreement in connection with the clinical development and commercialization of products covered by the collaboration, including non-refundable upfront license fees, contingent consideration payments based on the achievement of defined collaboration objectives and royalties on sales of commercialized products.
Revenue from our Collaboration Agreement is recognized when (i) persuasive evidence of an arrangement exists; (ii) transfer of technology has been completed, services have been performed or products have been delivered; (iii) the fee is fixed and determinable, and (iv) collection is reasonably assured.
For revenue agreements with multiple elements such as the Collaboration Agreement, we evaluate the agreements in accordance with ASC 605-25
Revenue Recognition - Multiple Element Arrangements
to identify the deliverables included within the agreement and evaluate which deliverables represent separate units of accounting based on the achievement of certain criteria including whether the deliverable has stand alone value.
Upfront payments for licenses are evaluated to determine if the licensee can obtain standalone value from the license separate from the value of the research and development services and other deliverables in the arrangement to be provided by us. The assessment of multiple-element arrangements also requires judgment in order to determine the allocation of revenue to each deliverable and the appropriate period of time over which the revenue should be recognized.
Under the Collaboration Agreement, we have determined that the license does not have standalone value separate from the research and development services because
JT Torii cannot resell such license on a standalone basis or use the license with its available resources to obtain any economic value without our participation. T
he license and the services are combined as one unit of accounting and upfront payments are recorded initially as deferred revenue in the balance sheet. Revenue is then recognized on a straight-line basis over an estimated performance period that is consistent with the term of performance obligations, unless we determine there is a discernible pattern of performance other than straight-line, in which case we use a proportionate performance method to recognize the revenue over the estimated performance period. We are recognizing the upfront fee on a straight-line basis over the initial period of performance of six years, which represents the estimated development period in the territories based on the initial development plan managed by the joint steering committee. The term of the agreement is through the expiration of the patents associated with serlopitant.
We periodically review our estimated periods of performance based on the progress under each arrangement and account for the impact of any changes in estimated periods of performance on a prospective basis.
At the inception of each agreement that includes milestone payments, including the Collaboration Agreement, we evaluate whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. We evaluate factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone, and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. Non‑refundable payments that are contingent upon achievement of a substantive milestone are recognized in their entirety in the period in which the milestone is achieved, assuming all other revenue recognition criteria are met. Other contingent payments in which a portion of the milestone consideration is refundable or adjusts based on future performance or non‑performance (e.g., through a penalty or clawback provision) are not considered to relate solely to past performance, and therefore, not considered substantive. Amounts that are not recognized as revenue due to the uncertainty as to whether they will be retained or because they are expected to be refunded are recorded as a liability. We recognize non‑substantive milestone payments over the remaining estimated period of performance once the milestone is achieved. Contingent payments associated with the achievement of specific objectives in certain contracts that are not considered substantive because we do not contribute effort to the achievement of such milestones are recognized as revenue upon achievement of the objective, as long as there are no undelivered elements remaining and no continuing performance obligations by us, assuming all other revenue recognition criteria are met. We are
entitled to receive aggregate payments of up to $28.0 million upon the achievement of specified development and regulatory milestones, and $15.0 million upon the achievement of a commercial milestone. Certain of the milestones related to preparation of an IND for submission to regulatory authorities in the territory are considered substantive given that they are triggered by our performance relative to the achievement of pre-specified, “at risk” milestone events, such as the initiation or successful completion of regulatory development phases. All other milestones are considered non-substantive because the milestone is dependent upon the performance of the collaboration partner rather than us.
On September 1, 2017, we entered into a new services agreement with JT Torii to provide research and development services, including regulatory, chemistry and manufacturing support and related materials that is distinct from the original Collaboration Agreement. We evaluated the new services agreement and determined that the research and materials delivered to JT Torii represents a separate earnings process that provides stand alone value to JT Torii. The fees received under the services agreement will be recognized as and when such services are performed by us and JT Torii consumes the benefits of those services. We have no obligation to provide services unless requested by JT Torii and agreed to by us. We are eligible to receive reimbursement of
estimated costs incurred and payment for research services performed directly by us at agreed upon rates. During the quarter ended September 30, 2017, we recognized revenue of $0.5 million related to the new services agreement.
The services agreement terminates upon the termination of the Collaboration Agreement or by mutual agreement of the parties.
Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in our balance sheets. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, current portion. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion.
Research and Development Expenses
Research and development costs are expensed as incurred. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized and recognized as an expense as the goods are delivered or the related services are performed.
We estimate non‑clinical study and clinical trial expenses based on the services performed pursuant to contracts with research institutions and clinical research organizations that conduct and manage non‑clinical studies and clinical trials on our behalf. 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 the estimate, we will adjust the accrual accordingly. Payments made to third parties under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses until the services are rendered.
Stock-Based Compensation Expense
We account for stock‑based compensation arrangements with employees in accordance with ASC 718,
Stock Compensation.
ASC 718 requires the recognition of compensation expense, using a fair value‑based method, for costs related to all stock‑based payments including stock options. Our determination of the fair value of stock options on the date of grant utilizes the Black‑Scholes option‑pricing model for stock options with time‑based vesting, and is impacted by our common stock price as well as changes in assumptions regarding a number of highly complex and subjective variables. These variables include expected term that options will remain outstanding, expected common stock price volatility over the term of the option awards, risk‑free interest rates and expected dividends.
The fair value is recognized over the period during which an optionee is required to provide services in exchange for the option award, known as the requisite service period (usually the vesting period) on a straight‑line basis.
Equity instruments issued to non‑employees are recorded at their fair value on the measurement date and are subject to periodic adjustments as the underlying equity instruments vest. The fair value of options granted to consultants is expensed when vested.
Estimating the fair value of equity‑settled awards as of the grant date using valuation models, such as the Black‑Scholes option pricing model, is affected by assumptions regarding a number of complex variables. Changes in the assumptions can materially affect the fair value and ultimately how much stock‑based compensation expense is recognized. These inputs are subjective and generally require significant analysis and judgment to develop.
Expected Term—
The expected term assumption represents the weighted average period that the stock‑based awards are expected to be outstanding. We have elected to use the “simplified method” for estimating the expected term of the options, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option.
Expected Volatility—
For all stock options granted to date, the volatility data was estimated based on a study of publicly traded industry peer companies. For purposes of identifying these peer companies, we considered the industry, stage of development, size and financial leverage of potential comparable companies.
Expected Dividend—
The Black‑Scholes valuation model valuation model calls for a single expected dividend yield as an input. We currently have no history or expectation of paying cash dividends on our common stock.
Risk‑Free Interest Rate—
The risk‑free interest rate is based on the yield available on U.S. Treasury zero‑coupon issues similar in duration to the expected term of the equity‑settled award.
The following assumptions were used to calculate the fair value of awards granted to employees and directors during the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
Nine Months Ended September 30,
|
|
|
2015
|
|
2016
|
|
2016
|
|
2017
|
Expected term (in years)
|
|
3.1
|
|
4.6 - 6.1
|
|
4.6 - 6.1
|
|
6.0 - 6.1
|
Volatility
|
|
74%
|
|
68% - 74%
|
|
68% - 71%
|
|
75% - 100%
|
Risk-free interest rate
|
|
1.0%
|
|
1.3% - 2.1%
|
|
1.3% - 1.5%
|
|
1.9% - 2.2%
|
Dividend yield
|
|
—
|
|
—
|
|
—
|
|
—
|
|
|
|
|
|
|
|
|
|
The following assumptions were used to calculate the fair value of awards granted to non employees during the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
Nine Months Ended September 30,
|
|
|
2015
|
|
2016
|
|
2016
|
|
2017
|
Expected term (in years)
|
|
1.0 - 1.8
|
|
9.3 - 10.0
|
|
9.5 - 9.8
|
|
8.5 - 10.0
|
Volatility
|
|
62% - 74%
|
|
84% - 86%
|
|
84% - 86%
|
|
74% - 100%
|
Risk-free interest rate
|
|
0.5% - 0.7%
|
|
1.6% - 2.5%
|
|
1.6%
|
|
2.1% - 2.5%
|
Dividend yield
|
|
—
|
|
—
|
|
—
|
|
—
|
|
|
|
|
|
|
|
|
|
We will continue to use judgment in evaluating the expected volatility, expected terms and interest rates utilized for our stock‑based compensation expense calculations on a prospective basis.
Stock‑based compensation expense, net of estimated forfeitures, is reflected in the statements of operations and comprehensive loss as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
Nine Months Ended September 30,
|
|
|
2015
|
|
2016
|
|
2016
|
|
2017
|
Research and development
|
|
$
|
1
|
|
|
$
|
257
|
|
|
$
|
127
|
|
|
$
|
676
|
|
General and administrative
|
|
64
|
|
|
316
|
|
|
184
|
|
|
541
|
|
Total stock-based compensation
|
|
$
|
65
|
|
|
$
|
573
|
|
|
$
|
311
|
|
|
$
|
1,217
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2016, total unamortized stock‑based compensation was $2.1 million, which is expected to be recognized over the remaining vesting period of 3.0 years. At
September 30, 2017
, there was approximately $4.4 million of unamortized compensation expense, which was expected to be recognized over a weighted average period of 2.8 years.
The intrinsic value of all outstanding stock options as of
September 30, 2017
was approximately $ million based on a hypothetical common stock fair value of $ per share, the midpoint of the estimated price range set forth on the cover page of this prospectus.
Common Stock Valuations
The estimated fair value of the common stock underlying our stock options was determined at each grant date by our board of directors, with input from management. All options to purchase shares of our common stock are intended to be exercisable at a price per share not less than the per share fair value of our common stock underlying those options on the date of grant.
In the absence of a public trading market for our common stock, on each grant date, we develop an estimate of the fair value of our common stock based on the information known to us on the date of grant, upon a review of any recent events and their potential impact on the estimated fair value per share of the common stock, and in part on input from an independent third‑party valuation. As is provided for in Section 409A of the Code, we generally rely on our valuations for up to twelve months unless we have experienced a material event that would have affected the estimated fair value per common share.
Our valuations of our common stock were determined in accordance with the guidelines outlined in the American Institute of Certified Public Accountants Practice Aid,
Valuation of Privately‑Held‑Company Equity Securities Issued as Compensation
, or the Practice Aid. The methodology to determine the fair value of our common stock included estimating the fair value of the enterprise using a market approach, which estimates the fair value of the company by including an estimation of the value of the business based on guideline public companies under a number of different scenarios. The assumptions used to determine the estimated fair value of our common stock are based on numerous objective and subjective factors, combined with management judgment, including external market conditions affecting the pharmaceutical and biotechnology industry and trends within the industry; our stage of development; the rights, preferences and privileges of our convertible preferred stock relative to those of our common stock; the prices at which we sold shares of our convertible preferred stock; our financial condition and operating results, including our levels of available capital resources; the progress of our research and development efforts, our stage of development and business strategy; equity market conditions affecting comparable public companies; general U.S. market conditions and the lack of marketability of our common stock.
The Practice Aid identifies various available methods for allocating enterprise value across classes and series of capital stock to determine the estimated fair value of common stock at each valuation date. In accordance with the Practice Aid, we considered the following methods:
|
|
▪
|
Option Pricing Method.
Under the option pricing method, shares are valued by creating a series of call options with exercise prices based on the liquidation preferences and conversion terms of each equity class. The estimated fair values of the preferred and common stock are inferred by analyzing these options.
|
|
|
▪
|
Probability‑Weighted Expected Return Method.
The probability‑weighted expected return method, or PWERM, is a scenario‑based analysis that estimates value per share based on the probability‑weighted present value of expected future investment returns, considering each of the possible outcomes available to us, as well as the economic and control rights of each share class.
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Based on our early stage of development and other relevant factors, we determined that a PWERM was the most appropriate method for allocating our enterprise value to determine the estimated fair value of our common stock for valuations performed for September 2016, December 2016, June 2017 and September 2017, which resulted in the fair value of our common stock being $1.32, $1.69, $1.79 and $2.60, respectively. In determining the estimated fair value of our common stock, our board of directors also considered the fact that our stockholders could not freely trade our common stock in the public markets. Accordingly, we applied discounts to reflect the lack of marketability of our common stock based on the weighted‑average expected time to liquidity. The estimated fair value of our common stock at each grant date reflected a non‑marketability discount partially based on the anticipated likelihood and timing of a future liquidity event.
Following the closing of this offering, our board of directors intends to determine the fair value of our common stock based on the closing price of our common stock on the Nasdaq Global Market on the date of grant.
Income Taxes
We provide for income taxes under the asset and liability method. Current income tax expense or benefit represents the amount of income taxes expected to be payable or refundable for the current year. Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and tax bases of assets and liabilities and net operating loss and credit carryforwards, and are measured using the enacted tax rates and laws that will be in effect when such items are expected to reverse. Deferred income tax assets are reduced, as necessary, by a valuation allowance when management determines it is more likely than not that some or all of the tax benefits will not be realized.
We account for uncertain tax positions in accordance with ASC 740‑10,
Accounting for Uncertainty in Income Taxes
. We assess all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. Assessing an uncertain tax position begins with the initial determination of the position’s sustainability and is measured at the largest amount of benefit that is greater than fifty percent likely of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and we will determine whether (i) the factors underlying the sustainability assertion have changed and (ii) the amount of the recognized tax benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax benefit might change as new information becomes available.
As of December 31, 2016 our total deferred tax assets were $11.6 million. Due to our lack of earnings history and uncertainties surrounding our ability to generate future taxable income, the net deferred tax assets have been fully offset by a valuation allowance. The deferred tax assets were primarily comprised of federal and state tax net operating losses, or NOLs. Utilization of NOLs may be limited by the “ownership change” rules, as defined in Section 382 of the Code. Similar rules may apply under state tax laws. Our ability to use our remaining NOLs may be further limited if we experience an ownership change in connection with this offering, future offerings or as a result of future changes in our stock ownership.
Investment Securities
We have an investment policy which limits us to investing in highly rated corporate and government notes, and no individual investment may comprise more than 5% of the total portfolio.
We classify our investment securities as available‑for‑sale. Those investments with maturities less than 12 months at the date of purchase are considered short‑term investments. Those investments with maturities greater than 12 months at the date of purchase are considered long‑term investments. Our investment securities classified as available‑for‑sale are recorded at fair value based upon quoted market prices at period end. Unrealized gains and losses, deemed temporary in nature, are reported as a separate component of comprehensive income or loss.
A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the security. Premiums (discounts) are amortized (accreted) over the life of the related security as an adjustment to yield using the straight‑line interest method. Dividend and interest income are recognized when earned. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of securities sold.
We determine the fair value of our assets and liabilities based on the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. We use a fair value hierarchy with three levels of inputs, of which the first two are considered observable and the last unobservable, to measure fair value:
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Level 1—Quoted prices in active markets for identical assets or liabilities;
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Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs
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that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and
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Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
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Off-Balance Sheet Arrangements
Since our inception, we have not engaged in any off‑balance sheet arrangements, as defined in the rules and regulations of the SEC. See Note 5 of our audited financial statements included in this prospectus, Commitments and Contingencies, regarding our guarantees and indemnifications.
Related Party Transactions
From 2011 through 2016, we have operated with significant consulting and management services provided by Velocity Pharmaceutical Development, LLC, or VPD. Development services fees paid to VPD under a development services agreement (the “Development Services Agreement”) were $0.8 million and $1.0 million for the years ended
December 31, 2015
and
2016
, respectively. Development services fees paid to VPD under the Development Services Agreement were $0.8 million and
$0
for the
nine
months ended
September 30, 2016
and 2017, respectively. We also reimbursed VPD for consulting, travel and other expenses incurred on our behalf. As of
December 31, 2016
and
September 30, 2017
, we had no outstanding liabilities to VPD. Several managing directors of VPD have served as officers and directors of the Company. David Collier, M.D., a former member of our board of directors, is the Chief Executive Officer of VPD, and Xiaoming Zhang, Ph.D., our Senior Vice President, Non‑Clinical and Pharmaceutical Development, was a Venture Partner of VPD.
We have entered into a services agreement with Theratrophix LLC, which is partially owned by Dr. Zhang. During the years ended
December 31, 2015
and
2016
, we incurred expenses of $39,000 and $270,000, respectively with Theratrophix. As of
December 31, 2015
and
2016
, there was an outstanding accounts payable balance of $39,000 and $0, respectively, owed to Theratrophix.
During the nine months ended
September 30, 2016
and
2017
, we incurred expenses of $247,000 and $105,000, respectively with Theratrophix. As of
September 30, 2017
, there were no outstanding accounts payable balance owed to Theratrophix.
Indemnification
As permitted under Delaware law and in accordance with our bylaws, we are required to indemnify our officers and directors for certain events or occurrences while the officer or director is or was serving in such capacity. We are also party to indemnification agreements with our directors. We believe the fair value of the indemnification rights and agreements is minimal. Accordingly, we have not recorded any liabilities for these indemnification rights and agreements as of
September 30, 2017
.
JOBS Act Accounting Election
The Jumpstart Our Business Startups Act of 2012, or the JOBS Act, permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies. We are choosing to “opt out” of this provision and, as a result, we will comply with new or revised accounting standards as required when they are adopted. This decision to opt out of the extended transition period under the JOBS Act is irrevocable.
Recently Issued and Adopted Accounting Pronouncements
In November 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2016‑18,
Statement of Cash Flows (Topic 230): Restricted Cash (a consensus of the FASB Emerging Issues Task Force)
. The update requires that the 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. ASU 2016‑18 is effective for public entities for annual periods beginning after December 15, 2017, and interim periods within those annual periods. We are currently evaluating the effects, if any, that the adoption of this guidance will have on our financial statements.
In March 2016, the FASB issued ASU 2016‑09,
Improvements to Employee Share‑Based Payment Accounting
as part of its simplification initiative, which involves several aspects of accounting for share‑based payment transactions, including the income tax effects, statutory withholding requirements, forfeitures and classification on the statement of cash flows. The standard is effective for companies for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years with early adoption permitted. We adopted this standard as of January 1, 2017, and there was no impact to our financial statements as a result of the adoption.
In February 2016, the FASB issued ASU 2016‑02,
Leases
(ASC 842), which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both parties to a contract (i.e., lessees and lessors). The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight‑line basis over the term of the lease, respectively. A lessee is also required to record a right‑of‑use asset and a lease liability for all leases with a term of greater than twelve months regardless of their classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases today. ASC 842 supersedes the previous leases standard, ASC 840
Leases
. The standard is effective on January 1, 2019, with early adoption permitted. We are currently evaluating the effects, if any, that the adoption of this guidance will have on our financial statements.
In January 2016, the FASB issued ASU 2016‑01,
Recognition and Measurement of Financial Assets and Financial Liabilities
, which addresses certain aspects of recognition, measurement, presentation and disclosure of financial instruments. ASU 2016‑01 is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. We are currently evaluating the effects, if any, that the adoption of this guidance will have on our financial statements.
In November 2015, the FASB issued ASU 2015‑17,
Balance Sheet Classification of Deferred Taxes
to simplify the presentation of deferred income taxes. The amendments in this update require that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. We elected to early adopt ASU 2015‑17 as of the beginning of our fourth quarter ended December 31, 2015 on a prospective basis. There was no impact to the balance sheet amounts as a result of early adoption.
In August 2014, the FASB issued ASU 2014‑15 related to
Presentation of Financial Statements
‑
Going Concern (Subtopic 205‑40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern.
This update provides guidance about management’s responsibilities in evaluating an entity’s going concern uncertainties, and about the timing and content of related footnote disclosures. Under this amended guidance, an entity’s management should evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. This update is effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early application is permitted. We adopted this standard in 2016 and there was no impact on the financial position, results of operations or related financial statement disclosures.
In June 2014, the FASB issued ASU 2014‑12,
Accounting for Share‑Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period
. ASU 2014‑12 requires that a performance target that affects vesting and could be achieved after the requisite service period be treated as a performance condition. ASU 2014‑12 is effective for us for the annual period ending after December 15, 2015 with early adoption permitted. The adoption of ASU 2014‑12 did not have a material effect on our financial statements.
In May 2014, the FASB issued ASU No. 2014‑09,
Revenue from Contracts with Customers (Topic 606)
, which supersedes the revenue recognition requirements in ASC 605,
Revenue Recognition
. This ASU is based on the principle that revenue is recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In August 2015, FASB issued ASU No. 2015‑14,
Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date
, which effectively delayed the adoption date by one year, to an effective date for public entities for annual and interim periods beginning after December 15, 2017. In March, April and May 2016, the FASB issued additional updates to the new revenue standard relating to reporting revenue on a gross versus net basis, identifying performance obligations and licensing arrangements, and narrow‑scope improvements and practical expedients, respectively. The effective date of this additional update is the same as that of ASU 2014‑09. The guidance permits the use of either a retrospective or cumulative effect transition method. We have not yet selected a transition method. We are still finalizing the analysis to quantify the adoption impact of the provisions of the new standard, but we do not currently expect to have a material impact on the financial position or results of operations. Based on the evaluation of our current collaboration agreement and associated revenue streams, most of the revenue will be recorded consistently under both the current and the new standard. The FASB has issued, and may issue in the future, interpretive guidance which may cause our evaluation to change. We believe we are following an appropriate timeline to allow for proper recognition, presentation and disclosure upon adoption effective the beginning of fiscal year 2018.
There are no other recently issued accounting standards that apply to us or that are expected to have a material impact on results of operations, financial condition, or cash flows.
Quantitative and Qualitative Disclosures about Market Risk
The market risk inherent in our financial instruments and in our financial position represents the potential loss arising from adverse changes in interest rates or exchange rates. As of
September 30, 2017
, we had cash, cash equivalents and investments of
$73.5 million
, consisting of interest‑bearing money market accounts and investments in corporate notes and government securities, which would be affected by changes in the general level of United States interest rates. However, due to the short‑term maturities and the low‑risk profile of our investments, an immediate 100 basis point change in interest rates would not have a material effect on the fair market value of our cash, cash equivalents and investments.
We do not believe that inflation, interest rate changes, or exchange rate fluctuations had a significant impact on our results of operations for any periods presented herein.
BUSINESS
Overview
We are a late‑stage biopharmaceutical company focused on the development and commercialization of serlopitant for the treatment of pruritus, or itch, associated with dermatologic conditions such as atopic dermatitis, psoriasis and prurigo nodularis. There are currently no therapies approved in the United States that are primarily intended to reduce the pruritus associated with these conditions. We are concurrently evaluating the use of serlopitant for the treatment of refractory chronic cough, a cough that persists for greater than eight weeks despite treatment of any identified underlying cause. There are currently no drugs specifically approved for refractory chronic cough in the United States. These indications each represent a significant patient need. We believe that serlopitant, a highly selective, once‑daily, oral small molecule inhibitor of the neurokinin 1 receptor, or NK
1
‑R, has the potential to significantly alleviate pruritus and refractory chronic cough symptoms.
We have initiated a broad clinical development program for serlopitant as a once‑daily oral tablet treatment for pruritus associated with multiple underlying chronic dermatologic conditions and for the treatment of refractory chronic cough. We expect data from our ongoing Phase 2 clinical trial in pruritus associated with atopic dermatitis in the second quarter of 2018 and from our ongoing Phase 2 clinical trials in pruritus associated with psoriasis and refractory chronic cough by late 2018 or early 2019. We plan to initiate two Phase 3 clinical trials in pruritus associated with prurigo nodularis in the first half of 2018, with results expected in the first half of 2020. If these and future clinical trials we may initiate are successful, we could potentially submit a New Drug Application, or NDA, for up to three indications in 2020: pruritus associated with atopic dermatitis, psoriasis and prurigo nodularis.
We have completed two double‑blind Phase 2 clinical trials in over 380 patients with pruritus and observed clinically relevant and statistically significant improvements in pruritus in patients treated with serlopitant compared to patients treated with placebo. The first Phase 2 clinical trial, conducted in 257 patients with chronic pruritus, met its primary and multiple secondary efficacy endpoints of pruritus reduction for patients treated at our two highest doses (5 mg and 1 mg daily) compared with those receiving placebo. The second Phase 2 clinical trial, conducted in 127 patients with prurigo nodularis, a severely pruritic skin condition with lesions, also met its primary and multiple secondary efficacy endpoints demonstrating significant pruritus reduction. Serlopitant has been dosed in more than 1,000 individuals and has been shown to be well tolerated, including when administered to patients in a clinical trial for up to one year.
More than 35 million patients in the United States are affected by atopic dermatitis, psoriasis, or prurigo nodularis. Pruritus is the primary complaint among such patients, often significantly impacting their quality of life. Current therapies, however, do not adequately control pruritus in many of these patients. Accordingly, there is a significant opportunity for a once‑daily oral tablet therapy for pruritus associated with these disease conditions. We believe that serlopitant, if approved, may be adopted by physicians as an oral anti‑pruritic therapy either as an adjunct to topical or systemic treatments or as a monotherapy in patients for whom management of pruritus is the primary patient need.
More than 10 million patients in the United States suffer from refractory chronic cough, for which no drugs have been specifically approved in the United States. Many patients report that their condition is frequently disabling and has a marked effect on their quality of life. Similar to pruritus, treatment options for refractory chronic cough are limited and may have inadequate benefit for many patients.
We have exclusive, royalty‑free development and commercialization rights to serlopitant in all markets other than Japan, where we have licensed serlopitant to JT Torii, for development and commercialization. In the United States, serlopitant has composition of matter patent protection into 2025, which may be extended for up to five years, issued methods of use patent protection for pruritus applications into 2033, and a filed provisional patent application for use in cough.
Members of our management team have extensive experience in product development, having held drug development, commercial and leadership roles at numerous biopharmaceutical and dermatology products companies, including Genentech/Roche, Gilead Sciences, Millennium Pharmaceuticals (acquired by Takeda), Relypsa (acquired by Galenica), Anacor Pharmaceuticals (acquired by Pfizer), Medicis Pharmaceutical (acquired
by Valeant), Connetics Corporation (acquired by Stiefel, now a division of GSK), BioForm Medical (acquired by Merz) and Merz Aesthetics. At their prior companies, our management team members have been involved in product development or commercialization of many successful dermatology products.
Our Strategy
Our goal is to become a fully integrated biopharmaceutical company focused on the development and commercialization of serlopitant. The key elements of our strategy are to:
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Obtain regulatory approval for serlopitant for the treatment of pruritus associated with multiple highly pruritic dermatologic conditions.
We plan to focus on the near term development and potential regulatory approval and commercialization of serlopitant for the treatment of pruritus associated with multiple dermatologic conditions. Following our discussions with the U.S. Food and Drug Administration, or FDA, and European regulatory agencies, we are advancing into Phase 3 clinical trials for the treatment of pruritus associated with prurigo nodularis. We have also commenced Phase 2 clinical trials for the treatment of pruritus associated with atopic dermatitis and psoriasis. If the results of these trials are promising, we intend to rapidly advance into Phase 3 clinical trials, for these indications, with the goal of seeking regulatory approval in the United States and Europe.
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Build a specialty sales organization to commercialize and market serlopitant in the United States, if approved.
If approved by the FDA for pruritus associated with our target dermatologic conditions, we intend to commercialize serlopitant by developing our own sales organization targeting a subset of the 10,000 to 12,000 dermatologists in the United States. If approved for pruritus associated with atopic dermatitis, we anticipate that we may need to expand this sales organization to reach high prescribing pediatricians and primary care physicians. Outside the United States, we intend to establish commercialization strategies for serlopitant as we approach possible commercial approval in each market, which may include collaborations with other companies.
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Develop serlopitant to treat refractory chronic cough.
We believe that the mechanistic overlap of the NK
1
‑R pathway in the pathology of pruritus and cough supports the development of serlopitant as a potentially efficacious therapy for patients suffering from refractory chronic cough. Our program builds upon data from several proof of concept studies with other NK
1
‑R antagonists. We are evaluating the efficacy and safety of serlopitant in our ongoing Phase 2 clinical trial for refractory chronic cough.
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Leverage our development and commercial infrastructure to expand our pipeline over time
.
We may elect in the future to pursue additional indications for serlopitant or in‑license or acquire drug candidates or commercial products that leverage our development or commercial capabilities.
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Our Serlopitant Development Programs
We are developing serlopitant for the treatment of pruritus associated with atopic dermatitis, psoriasis and prurigo nodularis. We are concurrently evaluating the use of serlopitant for the treatment of refractory chronic cough. Our development pipeline is summarized in the figure below:
Our collaborator in Japan, JT Torii, is also conducting a clinical development program for serlopitant in pruritus indications and is currently planning to initiate a Phase 2 clinical trial in 2018.
Clinical Need in Pruritus and Cough
Chronic Pruritus Overview
Chronic pruritus, defined as itching lasting longer than six weeks, can be as burdensome as chronic pain in negatively impacting a patient’s quality of life. The urge to scratch can be unbearable, and the act of scratching can remove layers of skin and break the skin barrier leading to bleeding, scarring and greatly increasing the risk of infection. Similar to chronic pain, severe chronic pruritus causes a number of physical and psychological issues that substantially impact patients’ day‑to‑day well‑being. Pruritus can lead to trouble sleeping, resulting in loss of work productivity and increased anxiety and depression as patients struggle to maintain self‑control.
Chronic pruritus is a hallmark of many dermatologic and systemic diseases, such as atopic dermatitis, psoriasis and prurigo nodularis, and is the predominant reason that patients with these diseases experience so much discomfort. In a recent report published in the Journal of the American Academy of Dermatology, up to 26% of the worldwide population suffers from chronic pruritus at some point in their lives.
Despite its prevalence, chronic pruritus is not well addressed by current therapies. Skin diseases such as atopic dermatitis, psoriasis and prurigo nodularis are commonly treated with a multi‑prong therapeutic approach. Skin barrier restoration and maintenance through application of topical moisturizers and treatment of skin lesions locally through the use of topical corticosteroids or other topical anti‑inflammatory agents are the predominant first‑line therapies for many pruritic skin diseases. Phototherapy and systemic immunomodulators including biologics are frequently used for more severe disease. These therapies may reduce pruritus to some degree in addition to their effects on skin health and inflammation. Yet many patients with atopic dermatitis, psoriasis, or prurigo nodularis still report high levels of pruritus despite active topical or systemic therapy. This significant medical need is reflected by the widespread use of therapies intended to address pruritus specifically, such as oral antihistamines, despite evidence demonstrating their relative lack of efficacy, as well as concerns regarding their safety and tolerability, such as sedative effects of antihistamines.
The itch‑scratch cycle can also undermine progress in treating skin lesions if pruritus is not addressed adequately. In any skin disease, but especially in atopic dermatitis, repeated itching and scratching can lead to secondary cutaneous infections. In psoriasis patients, scratching can lead to the development of new psoriatic lesions. Similarly, prurigo nodularis is characterized by excoriations, crusting and sometimes ulceration of
lesions due to the incessant scratching provoked by chronic pruritus. We believe that the pruritus associated with multiple distinct diseases, such as atopic dermatitis, psoriasis and prurigo nodularis, involves activation of a common neuronal pathway for itch signaling, enabling a drug that is effective in reducing pruritus associated with one disease to have efficacy in reducing pruritus in others.
Atopic Dermatitis Overview
There are an estimated 26 million people in the United States who
have
atopic dermatitis
, a
chronic, inflammatory skin disease that is most commonly first diagnosed in childhood.
Atopic dermatitis is characterized by skin barrier disruption and immune dysregulation. Patients with atopic dermatitis may have chronically inflamed skin lesions and often have persistent pruritus. Physicians and patients report pruritus as the primary patient complaint associated with this disease.
Of the total population of atopic dermatitis patients in the United States, an estimated 37% of those are actually diagnosed with the disease, and of those diagnosed, an
estimated 45‑50% of these patients are actively being treated by a physician.
Creams and ointments and topical corticosteroids or other topical or systemic anti‑inflammatory agents are routinely used to manage skin health and to reduce skin inflammation in patients with atopic dermatitis.
In our market research, dermatologists report that up to 30% of
the patients they treat for atopic dermatitis have inadequately controlled pruritus.
Psoriasis Overview
According to the World Health Organization, psoriasis, a common chronic autoimmune disorder of the skin, causing redness, irritation and scaly lesions, affects up to five percent of the world’s population. Approximately 12 million people in the United States
have psoriasis; of these, an estimated 7.5 million have been diagnosed with the skin disease and an estimated 50‑60% of diagnosed patients are actively being treated. Of those patients in active treatment, an estimated 50-60%
of these patients have moderate to severe pruritus. In a recent survey of 5,604 psoriasis patients, over 90% reported pruritus as a significantly bothersome symptom.
The severity of the pruritus in psoriasis patients does not always correlate with the
severity and number of skin lesions
, suggesting that pruritus and
skin inflammatory disease
may be somewhat independent of each other in
patients with
psoriasis.
Mild to moderate psoriasis is typically treated with topical therapies such as corticosteroids or vitamin D analogs. Moderate to severe psoriasis may be treated with topical therapies, systemic immunosuppressive or immunomodulatory drugs, or phototherapy. While all of these therapies can help reduce the skin irritation and plaques in patients with psoriasis, and may also reduce pruritus to some degree, they may not adequately resolve the pruritus associated with psoriasis.
Prurigo Nodularis Overview
We estimate that there are approximately 350,000
people with
prurigo nodularis in the United States. Prurigo nodularis is a chronic skin disorder affecting primarily older adults and is characterized by multiple, firm, itchy nodules typically found on a patient’s arms, legs and trunk. Prurigo nodularis results from a vicious cycle of repeated itching and scratching leading to formation of raised, inflamed skin nodules that can develop sores or become hard and crusty. The itching sensation in prurigo nodularis is extreme and often leads to scratching to the point of bleeding or pain. Prurigo nodularis may be associated with a variety of dermatologic and systemic diseases such as atopic dermatitis, psoriasis, diabetes, chronic renal failure and HIV infection.
No treatment for prurigo nodularis has been approved in the United States or Europe. A high priority in any treatment for prurigo nodularis is to identify and address any underlying cause of itching. However, specific trigger factors for the development of prurigo nodularis in an individual patient may be difficult to identify. Treatment of prurigo nodularis typically involves a multifaceted approach to treat the lesions and reduce itch. Therapies may include corticosteroids and other immunosuppressive or anti‑inflammatory treatments, phototherapy and agents such as gabapentin and Lyrica (pregabalin). Prurigo nodularis is often treatment resistant with high recurrence rates.
Refractory Chronic Cough Overview
Cough is a symptom of many underlying conditions such as respiratory infections, inflammatory conditions such as asthma, irritants such as smoke, and diseases that limit lung function. While cough from acute conditions usually resolves, it has been estimated that over 10% of adults have, or have had, chronic cough, a cough that
persists for greater than eight weeks, at some point in their lives. The most prevalent underlying conditions associated with chronic cough are asthma, gastroesophageal reflux disease, or upper respiratory infections. Approximately 40% of patients with chronic cough are diagnosed with refractory chronic cough, a chronic cough that persists despite treatment of any identified underlying cause.
Current treatment options for refractory chronic cough have demonstrated limited efficacy. The two most common antitussive drugs are codeine and dextromethorphan, neither of which appears to be efficacious in recently conducted trials. Furthermore, concerns about the safety and abuse liability of narcotics such as codeine have restricted their use.
Our Solution: Serlopitant
We are developing serlopitant, a small molecule, highly selective NK
1
‑R antagonist, as a once‑daily oral tablet therapy to reduce pruritus in patients with atopic dermatitis, psoriasis or prurigo nodularis, and to reduce cough frequency in patients with refractory chronic cough. We believe serlopitant has the potential to be a safe and efficacious treatment for pruritus and/or cough based on the following:
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Two multicenter randomized Phase 2 clinical trials have demonstrated a statistically significant reduction of pruritus
. Both of our completed double‑blind Phase 2 clinical trials met their primary efficacy analyses and multiple secondary efficacy endpoints, demonstrating greater reduction of pruritus in patients treated with serlopitant compared with the patients treated with placebo. In addition, several proof‑of‑concept preclinical studies and clinical trials with other NK
1
‑R antagonists have shown the benefit of NK
1
‑R inhibition in pruritus and cough.
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Serlopitant has been dosed in more than 1,000 individuals and has been shown to be well-tolerated, including when administered to patients in a clinical trial for up to one year.
Serlopitant has been studied in 13 completed Phase 1 clinical trials and four completed Phase 2 clinical trials, including the two Phase 2 clinical trials conducted by us for pruritus and two Phase 2 clinical trials conducted by Merck for other indications. In several of these clinical trials, much higher doses than our current target therapeutic dose have been used (in one study 50 mg was used for up to 28 days), and approximately 40 patients have been treated for up to one year at a dose comparable to our target therapeutic dose. We believe this safety experience supports development of serlopitant for chronic dosing.
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Serlopitant, if approved, could fit easily into the current treatment regimen for our target indications.
Serlopitant, if approved, would be a once‑daily oral tablet therapy and could be used as an adjunct to standard of care topical or systemic treatments for pruritic dermatologic conditions. The drug interaction profile of serlopitant supports its use with a wide range of standard of care therapies, and the simple once‑daily oral dosing regimen can be added to current therapy to manage pruritus. Serlopitant may also be used
as a monotherapy for patients for whom management of the pruritus or refractory chronic cough symptoms is the primary patient need.
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Background on Substance P and NK
1
-R
Serlopitant is a small molecule, highly selective NK
1
‑R antagonist. Two critical mediators of the urge to scratch and the urge to cough are Substance P, or SP, and its receptor, the neurokinin‑1 receptor, or NK
1
‑R. SP is a naturally occurring peptide in the tachykinin neuropeptide family. Tachykinins have a broad range of functions in the nervous and immune systems. SP binding of NK
1
‑R has been shown to be a key mediator of sensory nerve signaling, including the itch‑scratch reflex, the cough reflex and the vomiting reflex. Accordingly, the biological bases of our pruritus and cough programs are similar and have been shown to involve SP and NK
1
‑R in the signaling process. The following figure illustrates the role of NK
1
‑R in itch and cough signaling:
SP administration and NK
1
‑R inhibition have been validated in multiple animal models of human disease, which indicate potential therapeutic development paths in pruritus, cough and vomiting. Based upon the animal models of vomiting, NK
1
‑R antagonists have been successfully developed and commercialized as treatments for chemotherapy induced nausea and vomiting. In pruritus animal studies, SP injection can stimulate scratching and NK
1
‑R inhibition can stop scratching. Similarly, a study of canine cough has demonstrated that an NK
1
‑R antagonist can reduce cough frequency.
Proof of concept trials have been conducted in patients with pruritus with Emend (aprepitant), a commercially available NK
1
‑R antagonist. In an open label pruritus trial published in 2010, 20 patients with chronic pruritus refractory to other therapies were treated with aprepitant and 80% of these patients had significant alleviation of their pruritus after one week of treatment. Subsequent reports of aprepitant in other indications associated with pruritus such as
prurigo nodularis,
cutaneous T‑cell lymphoma and drug‑induced pruritus have also suggested efficacy at reducing pruritus associated with these disease conditions. Recently published or presented case studies and small proof of concept trials in patients with chronic cough have demonstrated the ability of NK
1
‑R antagonists to reduce cough frequency.
Our work builds upon the successful demonstration of activity in animal models and human proof of concept studies in pruritus and cough. We have leveraged the experience with NK
1
‑R antagonists to advance serlopitant quickly into Phase 2 studies in indications that present a significant opportunity and a strong basis for use of NK
1
‑R antagonism. Serlopitant has been designed to overcome many of the limitations of previous generation NK
1
‑R antagonists, such as aprepitant. Aprepitant is only approved for short term use associated with chemotherapy‑induced nausea and vomiting. Compared to aprepitant, serlopitant has a longer half‑life, fewer potential drug‑drug interactions, a more linear pharmacokinetic profile and was well tolerated when administered to patients in a clinical trial for up to one year.
Serlopitant Clinical Trials
We are conducting a clinical development program in patients with pruritus associated with atopic dermatitis, psoriasis and prurigo nodularis, and in patients with refractory chronic cough. A Phase 2 clinical trial in pruritus associated with atopic dermatitis (484 patients) has completed enrollment with results expected in the second
quarter of 2018. Phase 2 clinical trials in pruritus associated with psoriasis (200 patients) and refractory chronic cough (170 patients) are underway with results expected in late 2018 or early 2019. In the first half of 2018, we plan to initiate our Phase 3 clinical trials in pruritus associated with prurigo nodularis.
Chronic Pruritus Completed Phase 2 Clinical Trial
Trial Design
We completed a Phase 2 clinical trial in December 2014 to evaluate the safety and efficacy of serlopitant in patients with chronic pruritus. The study was a multicenter, randomized, double‑blind, placebo‑controlled trial in 257 adult patients (18 to 65 years of age) with pruritus for more than six weeks that were non‑responsive or inadequately responsive to topical steroids or antihistamines, and who had a baseline visual analog scale, or VAS of at least 70 mm. To report itch severity on the VAS, patients place a mark on a 100 mm line corresponding to the degree of severity of their pruritus. The distance from the origin of the line is measured to indicate pruritus severity, where 0 mm represents no itch and 100 mm represents the worst itch imaginable.
Patients underwent a screening period of up to two weeks. Eligible patients were randomized to one of four treatment groups (placebo or serlopitant 0.25 mg, 1 mg or 5 mg tablets), and began a six‑week treatment period, followed by a four‑week follow‑up period. At baseline, patients received a loading dose of three tablets. Thereafter, patients took one tablet every day at bedtime for six weeks. A total of 257 patients were randomized into one of the four groups (64 received a placebo, 64 received 0.25 mg serlopitant, 65 received 1 mg serlopitant and 64 received 5 mg serlopitant). The mean age was 43.7 years, and 60.7% of the patients were female. Demographics were generally balanced across treatment groups.
The primary efficacy analysis compared the percent change from baseline in itch VAS score in each serlopitant treatment group with the placebo group. An important secondary efficacy endpoint was percent change from baseline in itch on the Numeric Rating Scale, or NRS, an 11‑point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Other secondary efficacy endpoints included assessments of sleep and quality of life.
Efficacy Results
The study met its primary and multiple secondary efficacy endpoints of pruritus reduction for patients treated at our two highest doses (5 mg and 1 mg daily).
At week six, for the primary efficacy analysis, the serlopitant 5 mg group and serlopitant 1 mg group showed an improvement in pruritus of 42.5% and 41.4% from baseline, respectively, measured by the itch VAS. Each represents a statistically greater improvement compared with the placebo group improvement of 28.3% (5 mg, p = 0.013; 1 mg, p = 0.022).
P‑value is a conventional statistical method for measuring the statistical significance of clinical results. A p‑value of less than 0.05 is generally considered to represent statistical significance, meaning that there is a less than five percent likelihood that the observed results occurred by chance.
The figure below shows the weekly itch VAS percentage change from baseline assessment for all four groups in this chronic pruritus Phase 2 clinical trial:
Serlopitant at 5 mg and 1 mg also demonstrated superior efficacy over placebo for the secondary efficacy endpoint of percent change from baseline in itch NRS. At week six, the
serlopitant 5 mg group and serlopitant 1 mg group showed an improvement in pruritus of 39.0% and 39.4% from baseline, respectively, measured by the itch NRS score. Each represents a statistically greater improvement compared with the placebo group improvement of 28.7% (5 mg, p = 0.038; 1 mg, p = 0.031).
After the completion of the trial, we conducted additional (post‑hoc) analyses to look at patients with at least 40 mm of improvement on the itch VAS or a 4‑point improvement on itch NRS scores. These analyses were conducted to help us plan and power future clinical trials based upon our interactions with the FDA. In this analysis of itch VAS responders, 52.8% of patients receiving 5 mg serlopitant had at least a 40 mm improvement in itch VAS compared with 25.9% of patients in the placebo group showing similar improvement (p=0.004). 46.2% of patients receiving 5 mg serlopitant had at least a 4‑point improvement on the itch NRS as compared to 22.6% of patients in the placebo group (p = 0.011).
The following table summarizes VAS and NRS efficacy outcomes at week six in the chronic itch Phase 2 clinical trial
:
|
|
|
|
|
|
|
|
|
Endpoint
|
Placebo
|
Serlopitant 0.25 mg
|
Serlopitant 1 mg
|
Serlopitant 5 mg
|
|
p‑value*
|
|
p-value*
|
|
p-value*
|
|
Mean Percent Change from Baseline Analyses
|
|
VAS % change
|
-28.3%
|
-34.1%
|
p = 0.309
|
-41.4%
|
p = 0.022
|
-42.5%
|
p = 0.013
|
NRS % change
|
-28.7%
|
-35.8%
|
p = 0.153
|
-39.4%
|
p = 0.031
|
-39.0%
|
p = 0.038
|
|
Responder Rate Analyses
|
|
VAS ≥ 40mm
responder rate
|
25.9%
|
42.6%
|
p = 0.068
|
38.2%
|
p = 0.171
|
52.8%
|
p = 0.004
|
NRS ≥ 4-point
responder rate
|
22.6%
|
38.5%
|
p = 0.078
|
32.7%
|
p = 0.242
|
46.2%
|
p = 0.011
|
|
|
*
|
All p-values compare treatment group versus placebo group.
|
Safety Results
Serlopitant was well tolerated in this study. No serious adverse events, or SAEs, were assessed as definitely, probably, or possibly related to serlopitant. The most common treatment emergent adverse event, or TEAEs, in the serlopitant groups were diarrhea (6.2%, 1 mg group), upper respiratory tract infection (4.7%, 0.25 mg group), somnolence (4.7%, 5 mg group), nasopharyngitis (4.6%, 1 mg group), headache (4.6%, 1 mg group), urinary tract infection (3.1%, 5 mg group), dry mouth (3.1%, 1 mg group), nausea (3.1%, 1 mg group), arthralgia (3.1%, 0.25 mg group), musculoskeletal pain (3.1%, 1 mg group), and pruritus (3.1%, 0.25 and 1 mg groups). The most common TEAEs in the placebo group were headache (6.3%), nasopharyngitis (3.2%), upper respiratory tract infection (3.2%), urinary tract infection (3.2%) and asthma (3.2%).
Prurigo Nodularis Completed Phase 2 Clinical Trial
Trial Design
We completed a Phase 2 clinical trial in June 2016 to evaluate the safety and efficacy of serlopitant in patients with prurigo nodularis. The study was a multicenter, randomized, double‑blind, placebo‑controlled study in 127 adult patients (18 to 80 years of age) who had prurigo nodularis for more than six weeks, whose pruritus was nonresponsive or inadequately responsive to topical steroids or
antihistamine
and who had a baseline VAS pruritus score of at least 70 mm.
Patients underwent a screening period of up to four weeks. Eligible patients were randomized to either the serlopitant 5 mg group or the placebo group, and began an eight‑week treatment period, followed by a two‑week follow‑up period. At baseline, patients received a loading dose of three tablets. Thereafter, patients took one tablet every day at bedtime for eight weeks. A total of 127 randomized patients received study drug in one of the two arms (63 received placebo, 64 received 5 mg serlopitant). The mean age was 57.6 years, and 52.8% of the patients were female. Demographics were generally balanced across the two treatment arms.
The primary efficacy analysis was the change in average itch VAS from baseline in patients in the serlopitant treatment group compared with placebo. The week four and eight tests were considered primary; hence, there were two primary comparisons, one for each visit. Secondary efficacy analyses included additional itch assessments such as the worst itch VAS and average and worst itch NRS, quality of life measures and assessments of prurigo nodularis lesion severity. Safety endpoints included TEAEs, laboratory values, vital signs and electrocardiogram findings.
Efficacy Results
The study met its primary and multiple secondary efficacy endpoints of pruritus reduction in patients in the serlopitant treatment group
compared with placebo
. For the primary efficacy analysis defined as change from baseline in average itch VAS at weeks four and eight, a serlopitant dose of 5 mg given once a day led to a
superior change from baseline in average itch VAS than placebo. At week four, the serlopitant 5 mg group showed a 25 mm improvement from baseline in average itch VAS compared to a 15 mm improvement from baseline in the placebo group (p = 0.025), and at week eight, the serlopitant 5 mg group showed an improvement of 36 mm from baseline in average itch VAS compared with an improvement of 19 mm for the placebo group (p = 0.001). Patients receiving 5 mg serlopitant had a statistically significant reduction in the average itch VAS score for pruritus compared to the placebo group at every measured time point.
The figure below shows comparative reduction in pruritus between the serlopitant treatment group and the placebo group in this Phase 2 clinical trial of pruritus associated with prurigo nodularis:
The figure below shows the distribution of average itch VAS percentage change from baseline at week 8 using a cumulative distribution function, or CDF, which shows a continuous plot of the change from baseline on the X-axis and the percentage of patients experiencing that change on the Y-axis.
The leftward shift of the curve for the serlopitant-treated patients indicates that these subjects were more likely than placebo-treated subjects to have any given degree of reduction in average VAS score.
Serlopitant also demonstrated superior efficacy over placebo in multiple additional predefined measures of itch VAS and NRS change from baseline. The chart below summarizes the VAS and NRS in this study. After the study was completed, we conducted post‑hoc analyses of responder rates using a responder definition of 40 mm VAS improvement or a 4‑point NRS improvement. These responder analyses were conducted for the purposes of planning our Phase 3 clinical trials and are consistent with the 4‑point improvement responder definition we have set as the primary efficacy analysis for our planned Phase 3 clinical trials in pruritus associated with prurigo nodularis.
The following table summarizes VAS and NRS efficacy outcomes at week eight in the prurigo nodularis Phase 2 clinical trial:
|
|
|
|
|
Endpoint
|
Placebo
|
Serlopitant 5 mg
|
Treatment Effect Difference (p-value)
|
|
Mean Change from Baseline Analyses
|
|
Average-itch VAS change from baseline
|
-19 mm
|
-36 mm
|
17 mm (p = 0.001)
|
Worst-itch VAS change from baseline
|
-20 mm
|
-36 mm
|
16 mm (p = 0.002)
|
Average-itch NRS change from baseline
|
-2.4 points
|
-3.7 points
|
1.4 points (p = 0.007)
|
Worst-itch NRS change from baseline
|
-2.3 points
|
-3.3 points
|
1.0 points (p = 0.056)
|
|
Responder Rate Analyses
|
|
Average-itch VAS ≥ 40 mm responder rate
|
25.0%
|
54.4%
|
29.4% (p = 0.002)
|
Worst-itch VAS ≥ 40 mm responder rate
|
17.4%
|
47.4%
|
30.0% (p = 0.001)
|
Average-itch NRS ≥ 4-point responder rate
|
28.2%
|
51.2%
|
23.0% (p = 0.034)
|
Worst-itch NRS ≥ 4-point responder rate
|
25.6%
|
46.5%
|
20.9% (p = 0.050)
|
Several additional measures of pruritus
and prurigo nodularis severity rec
orded in the study as exploratory or secondary measures also indicated greater improvement in serlopitant-treated patients compared with the placebo-treated patients.
Safety Results
Serlopitant was well tolerated in this study. Two patients had SAEs that were assessed as possibly related to serlopitant (depression and dizziness/vertigo). The most common TEAEs in the serlopitant group were nasopharyngitis (17.2%), diarrhea (10.9%), fatigue (9.4%), dizziness (7.8%), headache (6.3%), peripheral edema (6.3%), pruritus (4.7%), hypertension (4.7%), vomiting (3.1%), bronchitis (3.1%) and cough (3.1%). The most common TEAEs in the placebo group were pruritus (11.1%), fatigue (6.3%), headache (6.3%), urinary tract infection (6.3%), diarrhea (4.8%), nasopharyngitis (3.2%), nausea (3.2%), upper abdominal pain (3.2%), asymptomatic bacteriuria (3.2%), bradycardia (3.2%), eczema (3.2%), insomnia (3.2%) and oral herpes (3.2%).
Prurigo Nodularis Planned Phase 3 Clinical Trials
We intend to initiate two multicenter, placebo‑controlled, double‑blind Phase 3 clinical trials of serlopitant
for the treatment of pruritus associated
with prurigo nodularis in
the first half of 2018
. These trials are intended to evaluate if treatment with 5 mg serlopitant daily for eight weeks can reduce pruritus associated with prurigo nodularis compared with placebo. We expect to
enroll 200 patients in each study and
conduct one trial in the United States and one trial in Europe, with approximately 50 sites in each study. The trials will enroll patients with a worst‑itch NRS score, or WI‑NRS, of at least seven at screening. The primary efficacy analysis for both of these trials is a four‑point responder rate in the WI‑NRS at eight weeks. Secondary efficacy endpoints will include WI‑NRS at four weeks, change in WI‑NRS from baseline to day seven and day three, change in number of night time scratching events from baseline to week eight and changes in a measure of scratching behavior. Results from both trials are expected in the first half of 2020.
In parallel with the two Phase 3 efficacy and safety trials in prurigo nodularis, we intend to initiate an open label long‑term safety trial in which patients will receive treatment doses of 5 mg serlopitant for one year.
Atopic Dermatitis Ongoing Phase 2 Clinical Trial
In December 2016, we commenced a multicenter, placebo‑controlled double‑blind Phase 2 clinical trial of serlopitant for the treatment of pruritus associated with atopic dermatitis. The trial is being conducted at more than 50 sites in the United States and enrolled 484 patients age 13 or over who have a past or present diagnosis of atopic dermatitis, have pruritus for at least six weeks and a screening WI‑NRS pruritus score of at least seven. Patients were randomized into one of three arms: daily doses of 1 mg serlopitant, 5 mg serlopitant or placebo. The trial includes a six‑week treatment period and four‑week follow up period. This trial is intended to evaluate if treatment with either 5 mg or 1 mg serlopitant daily for six weeks can reduce pruritus associated with atopic dermatitis compared with placebo. The primary efficacy analysis will compare serlopitant versus placebo changes on WI‑NRS at week six. The trial is fully enrolled, and we expect data from this trial to be available in the second quarter of 2018.
Psoriasis Ongoing Phase 2 Clinical Trial
In October 2017, we commenced a multicenter, placebo‑controlled double‑blind Phase 2 clinical trial of serlopitant as a treatment for pruritus associated with psoriasis. This trial is being conducted at approximately 40 sites in the United States and is expected to enroll approximately 200 patients between the ages of 18 and 80 who have had plaque‑type psoriasis for at least 6 months, a maximum psoriasis body surface area of 10% have pruritus for at least four weeks and a screening WI‑NRS pruritus score of at least seven. The trial includes an eight‑week treatment period and two‑week follow up period. This trial is intended to evaluate if treatment with 5 mg serlopitant daily for eight weeks can reduce pruritus associated with psoriasis as compared with placebo. The primary efficacy analysis will compare serlopitant versus placebo changes on WI‑NRS at week eight. We enrolled the first patients in the trial in November 2017 and we expect data from this trial to be available in late 2018 or early 2019.
Cough Ongoing Phase 2 Clinical Trial
In October 2017, we commenced a multicenter, placebo‑controlled double‑blind Phase 2 clinical trial of serlopitant in patients with refractory chronic cough. This trial is being conducted at approximately 40 sites in
the United States and the United Kingdom and is expected to enroll approximately 170 patients between the ages of 18 and 80 who have had treatment refractory chronic cough or unexplained cough for at least one year. This trial includes a twelve‑week treatment period and four‑week follow‑up period. This trial is intended to evaluate if treatment with 5 mg serlopitant daily for 12 weeks can reduce cough frequency in patients with refractory chronic cough as compared with placebo. We
enrolled the first patients in the trial in October 2017, and we
expect data from this trial to be available in late 2018 or early 2019.
Other Clinical Studies
In addition to our efficacy and safety studies noted above, we are conducting a study to better understand the effect of food on absorption and blood levels of serlopitant, and an adolescent pharmacokinetics study to demonstrate the dose kinetics of serlopitant in children ages 12 to 17. We anticipate that we will in the future conduct additional pharmacokinetics studies in specific populations, a standard cardiovascular safety study required for any NDA submission, and other studies as needed to support our applications for regulatory approval in the United States and Europe.
An investigator at Stanford University has recently completed an independent investigator-sponsored exploratory study of serlopitant as a treatment to reduce pruritus associated with Epidermolysis Bullosa, or EB, a rare, severe skin condition occurring primarily in children and young adults. The study involved fourteen patients, seven treated with serlopitant 5mg per day and seven with placebo. Based upon preliminary communication from the investigator, treatment with serlopitant was associated with greater pruritus reduction than treatment with placebo, although the primary efficacy analysis was not statistically significant in this small study. We expect the EB study results to be reported at a scientific conference in 2018.
Safety
Serlopitant has been dosed in more than 1,000 individuals across 13 completed Phase 1 studies and four completed Phase 2 studies. Single doses up to 400 mg and doses up to 50 mg a day for four weeks have been administered. Doses of 4 mg (in a liquid filled capsule, which provides comparable exposure to our current 5 mg tablet) a day for up to one year have been administered. The safety profile to date indicates that serlopitant is well tolerated. Across all completed Phase 2 studies, including the trials conducted by Merck, no SAEs to date have been assessed as probably or definitely related to serlopitant, and only four patients have experienced SAEs that were assessed as possibly related to serlopitant. The most commonly reported treatment‑emergent adverse events across all completed Phase 2 studies were nasopharyngitis (6.4%, as compared to 3.8% for patients treated with placebo), urinary tract infection (6.0%, as compared to 3.1% for patients treated with placebo), diarrhea (6.0%, as compared to 5.0% for patients treated with placebo) and headache (5.6%, as compared to 7.5% for patients treated with placebo).
The non-clinical safety profile of serlopitant has been well characterized. The safety of serlopitant was evaluated in genetic toxicity, acute toxicity, repeated dose oral toxicity studies up to nine months in duration, two‑year oral carcinogenicity studies, developmental toxicity studies, fertility and reproduction studies and local tolerability (dermal and ocular) studies. Serlopitant was neither mutagenic nor genotoxic in
in vitro
and
in vivo
assays. Additional non‑clinical studies are planned to support NDA submission and pediatric development, including a pre and post‑natal development study and a juvenile toxicology study.
Regulatory Pathway
We have completed an end‑of‑Phase 2 review process with the FDA for pruritus associated with prurigo nodularis and have presented the FDA with the design, the target population, key endpoint measures, and other clinical trial design elements of our planned Phase 3 clinical trials in pruritus associated with prurigo nodularis. We have also completed a CMC end‑of‑Phase 2 review with the FDA, which provided clear guidance on the work remaining to support the CMC information to be presented in the NDA, all of which is consistent with our ongoing and planned activities.
Scientific advice meetings have been completed with regulatory authorities in three European countries and such meetings have provided clear guidance with respect to the regulatory path supporting submission of an MAA for pruritus associated with prurigo nodularis and our broader pruritus program.
We anticipate that development of serlopitant for use in pediatric patients will be a required element of our development program for some of our target indications. We are developing a pediatric plan for review with regulatory authorities in Europe and the United States.
Prior to the start of our Phase 2 study in pruritus associated with atopic dermatitis, we discussed this trial design with the FDA and received confirmation that we can pursue such a pruritus indication with helpful feedback regarding primary efficacy analysis considerations, statistical considerations and other key elements of the development program for pruritus associated with atopic dermatitis.
From the multiple discussions we have had with the FDA and the European regulatory authorities, we believe that our serlopitant development program can be directed to the specific indications of pruritus associated with each of atopic dermatitis, psoriasis, and prurigo nodularis. If our ongoing and future clinical trials are successful, we could potentially submit an NDA for pruritus associated with up to three indications in 2020: pruritus associated with atopic dermatitis, psoriasis, and prurigo nodularis.
We have received clearance from the FDA of an IND to conduct our Phase 2 clinical trial in refractory chronic cough.
We enrolled the first patient in the clinical trial in October 2017.
Competition
The biopharmaceutical industry is intensely competitive and is subject to rapid and significant change. We face competition from other pharmaceutical and biotechnology companies, research institutions and other organizations. We consider our primary competitors to be those companies that are developing drugs specifically to treat pruritus associated with a variety of underlying dermatologic or systemic conditions, companies that are developing drugs specifically to treat chronic cough, companies that are developing and marketing other NK
1
‑R antagonists for pruritus or other conditions, that, when approved, could be used off‑label to treat pruritus or cough, and companies that currently market or are developing treatments intended directly to treat the underlying disease condition in atopic dermatitis, psoriasis, or prurigo nodularis that have also been shown to have anti‑pruritic effects.
We are aware of other companies targeting pruritus or chronic cough as the primary outcome measure in clinical studies of drugs. There are multiple companies developing products at varying stages of development specifically intended to treat pruritus including: Vanda Pharmaceuticals, Trevi Therapeutics, Galderma, Sienna Biopharmaceuticals, Tioga and Cara Therapeutics. In addition, Merck and Nerre Therapeutics are developing therapeutic treatments for chronic cough. Of these companies, Vanda and Nerre are developing NK
1
‑R antagonists for indications t
hat may compete directly with serlopitant.
Other companies, including Tesaro and Merck, are also marketing or developing NK
1
‑R antagonists for other indications and could compete with serlopitant.
License and Collaboration Agreements
JT Torii Agreements
In August 2016, we entered into an exclusive royalty‑bearing license and collaboration agreement with JT Torii, for the development and commercialization of products containing serlopitant in Japan for the treatment of diseases and conditions other than nausea and vomiting. Torii currently markets Remitch in Japan for pruritus in patients on dialysis. Under our agreement, we received an upfront, non‑refundable payment of $11.0 million. In addition, we are entitled to receive aggregate payments of up to $28.0 million upon the achievement of specified development and regulatory milestones, and $15.0 million upon the achievement of a commercial milestone, as well as tiered royalties from the mid-single digits
up to the mid-teens
on sales of licensed products in Japan. We are primarily responsible for prosecuting, maintaining and enforcing licensed patent rights in Japan. The agreement contains customary representations, warranties, and indemnities, and terminates on a product‑by‑product basis upon the later of the last to expire patent covering a licensed product under the agreement or 10 years after the first commercial sale of such product, after which the licenses granted with respect to such product become perpetual, irrevocable and non‑exclusive. The currently issued patents covering a licensed product under the agreement is expected to expire in 2025. Currently issued, are expected to expire between 2034 and 2038. JT Torii may terminate the agreement without cause at any time upon advance written notice to us. We may terminate the agreement if JT Torii or its affiliates challenges the validity, enforceability, or scope of any licensed patents anywhere in the world.
Either party may terminate the Collaboration Agreement for
the other party’s material breach or for certain bankruptcy or insolvency related events. We have also entered into a Supply Agreement and a Services Agreement with JT Torii pursuant to which they reimburse us for certain supplies, services and expenses.
In September 2017, we entered into a services agreement with JT Torii to provide research and development services, including regulatory, chemistry and manufacturing support and related materials. We have no obligation to provide services unless requested by JT Torii and agreed to by us. We are eligible to receive reimbursement of estimated costs incurred and payment for research services performed directly by us at agreed upon rates. The services agreement terminates upon the termination of the Collaboration Agreement or by mutual agreement of the parties.
Merck License
In December 2012, we entered into a license agreement with Merck for exclusive worldwide royalty‑free rights for the development and commercialization of serlopitant and two other NK
1
‑R antagonists in all human diseases, disorders or conditions, except for the treatment or prevention of nausea or vomiting. We paid Merck an upfront licensing fee of $1.0 million and issued to Merck an aggregate of 3,353,450 shares of our common stock. In addition, we have agreed to make aggregate payments of up to $25.0 million upon the achievement of specified development and regulatory milestones for serlopitant. Furthermore, if we choose to pursue the development of any other products pursuant to this agreement, we may owe up to an aggregate of $50.0 million of additional payments upon the achievement of specified development and regulatory milestones.
In the near term, upon dosing our first patient in our Phase 3 clinical trial for serlopitant for the treatment of pruritus associated with prurigo nodularis, we will be obligated to make a milestone payment of $3.0 million to Merck.
We are responsible for the prosecution and enforcement of patents licensed under the agreement. The agreement contains customary representations, warranties, and indemnities, and terminates on the date of achievement of all of milestones set forth in the agreement, after which our licenses become fully paid and perpetual.
Each party may also terminate the agreement for material breach by the other party or for certain bankruptcy or insolvency related events, and we may terminate the agreement without cause at any time upon advance written notice to Merck.
Manufacturing
We currently contract with third parties for the manufacture of serlopitant drug substance and drug product for clinical trials and intend to continue doing so in the future. We require all of our contract manufacturing organizations, or CMOs, to conduct manufacturing activities in compliance with current good manufacturing practice, or cGMP, requirements. We have assembled a team of experienced employees and consultants to provide the necessary technical, quality and regulatory oversight over our CMOs. We rely solely on these third‑party manufacturers for scale‑up and process development work and to produce sufficient quantities of serlopitant for use in clinical and non-clinical studies. We currently have development contracts and quality agreements with two CMOs
for the manufacturing of serlopitant drug substance and drug product. We anticipate that these CMOs will have capacity to support commercial scale production, but we do not have any formal agreements at this time with either of these CMOs to cover commercial production. We also may elect to pursue additional CMOs for manufacturing supplies of regulatory starting materials in the future. We currently have no plans to establish our own manufacturing capabilities and plan to continue to rely on third‑party manufacturers for any future trials and commercialization of serlopitant, if approved.
Commercial Operations
We currently have no marketing and sales organization. If approved by the FDA for pruritus associated with our target dermatologic conditions, we intend to market and commercialize serlopitant by developing our own sales organization targeting a subset of the 10,000 to 12,000 dermatologists in the United States. If approved for pruritus associated with atopic dermatitis, we anticipate that we may need to expand this sales organization to reach high prescribing pediatricians and primary care physicians. If approved by the FDA for refractory chronic cough, we believe we can establish a direct sales organization targeting the approximately 10,000 pulmonologists and allergists in the United States. Outside the United States, we intend to establish commercialization strategies for serlopitant as we approach possible commercial approval in each market, which may include collaborations with other companies.
Intellectual Property
Our commercial success depends in part on our ability to obtain and maintain proprietary protection for our drug candidates, manufacturing and process discoveries, and other know‑how, to operate without infringing the proprietary rights of others, and to prevent others from infringing our proprietary rights. Our policy is to seek to protect our proprietary position by, among other methods, filing U.S. and foreign patent applications related to our proprietary technology, inventions and improvements that are important to the development and implementation of our business. We also rely on trade secrets, know‑how, continuing technological innovation and potential in‑licensing opportunities to develop and maintain our proprietary position.
With regard to serlopitant, we intend to pursue composition‑of‑matter patents, where possible, and dosage and formulation patents, as well as method‑of‑use patents on novel indications for known compounds.
As of December 2017, we own, co‑own, or have an exclusive license to 11 issued U.S. patents and 51 issued foreign patents, which include granted European patent rights that have been validated in various EU member states, and 5 pending U.S. patent applications and 19 pending foreign patent applications.
The patent portfolio for serlopitant is directed to cover compositions of matter and methods of treatment. This patent portfolio includes issued U.S. patents, pending U.S. patent applications and corresponding foreign national and regional counterpart patents and patent applications. The issued composition of matter patent (U.S. Patent No. 7,217,731), is exclusively licensed from Merck and if the appropriate maintenance fees are paid, is expected to expire in 2025. We own or co‑own the patents and patent applications relating to the use of serlopitant. The issued methods of use patents (U.S. Patent Nos. 8,906,951; 9,198,898; 9,381,188; 9,474,741; 9,486,439, 9,737,507 and 9,737,508), if the appropriate maintenance fees are paid, are expected to expire in 2033. Additional patent term may be awarded for one of the serlopitant U.S. patents as a result of the patent term extension provision of the Hatch‑Waxman Amendments of 1984, or the Hatch‑Waxman Act.
The term of composition of matter patents and patent applications, if issued, relating to serlopitant in other jurisdictions (some of the major jurisdictions include Australia, Canada, China, Denmark, France, Germany, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Spain, Sweden, Switzerland, Taiwan, United Kingdom and India) and methods of use patents and patent applications, if issued, relating to serlopitant (some of the major jurisdictions include Australia, Brazil, Canada, China, Europe, India, Indonesia, Israel, Japan, Korea and Mexico), if the appropriate maintenance, renewal, annuity and other government fees are paid, are expected to expire between 2025 and 2034. These patents and patent applications (if applicable), depending on the national laws, may benefit from extension of patent term in individual countries if regulatory approval of serlopitant is obtained in those countries. In the European Union member countries, for example, a supplementary protection certificate, if obtained, provides a maximum five years of market exclusivity. Likewise, in Japan, the term of a patent may be extended by a maximum of five years in certain circumstances.
Additional U.S. and PCT patent applications relating to serlopitant are pending. Patents resulting from these applications, if issued, and if the appropriate maintenance, renewal, annuity, and other government fees are paid, are expected to expire between 2037 and 2038.
We also protect our proprietary technology and processes, in part, by confidentiality and invention assignment agreements with our employees, consultants, scientific advisors and other contractors. These agreements 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. To the extent that our employees, consultants, scientific advisors or other contractors use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know‑how and inventions.
Our commercial success will also depend in part on not infringing the proprietary rights of third parties. It is uncertain whether the issuance of any third‑party patent would require us to alter our development or commercial strategies, alter our drugs or processes, obtain licenses or cease certain activities. Our breach of any license agreements or failure to obtain a license to proprietary rights that we may require to develop or commercialize our future drugs may have a material adverse impact on us. If third parties prepare and file patent applications in the United States that also claim technology to which we have rights, we may have to
participate in interference proceedings in the United States Patent and Trademark Office, or USPTO, to determine priority of invention.
Government Regulation
The FDA and comparable regulatory authorities in state and local jurisdictions and in other countries impose substantial and burdensome requirements upon companies involved in the clinical development, manufacture, marketing and distribution of drugs, such as serlopitant. These agencies and other federal, state and local entities regulate, among other things, the research and development, testing, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion, distribution, post‑approval monitoring and reporting, sampling and export and import of our product candidate.
U.S. Government Regulation of Drug Products
In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA’s refusal to approve pending NDAs, withdrawal of an approval, imposition of a clinical hold, issuance of warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.
The process required by the FDA before a drug may be marketed in the United States generally involves the following:
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completion of non-clinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice, or GLP, regulations;
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submission to the FDA of an investigational new drug application, or IND, which must become effective before human clinical trials may begin in the United States;
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approval by an independent institutional review board, or IRB, at each clinical site before each trial may be initiated;
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performance of adequate and well‑controlled human clinical trials in accordance with good clinical practice, or GCP, requirements to establish the safety and efficacy of the proposed drug product for each indication;
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submission to the FDA of an NDA;
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satisfactory completion of an FDA advisory committee meeting, if applicable;
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satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with cGMP requirements and to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity;
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satisfactory completion of FDA audits of clinical trial sites and the sponsor’s clinical trial records to assure compliance with GCPs and the integrity of the clinical data;
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payment of user fees and securing FDA approval of the NDA; and
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compliance with any post‑approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy, or REMS, and the potential requirement to conduct post‑approval studies.
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Non-clinical Studies
Non-clinical studies include laboratory evaluation of product chemistry and formulation, as well as animal studies to assess safety, toxicity and efficacy.
The conduct of the non-clinical tests must comply with federal
regulations and requirements, including GLPs.
An IND sponsor must submit the results of the non-clinical tests, together with manufacturing information, analytical data and any available clinical data or literature, among other things, to the FDA as part of an IND. Some non-clinical testing may continue even after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to one or more proposed clinical trials and places the clinical trial on a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.
Clinical Trials
Clinical trials involve the administration of the investigational new drug to human patients under the supervision of qualified investigators in accordance with GCP requirements, which include the requirement that all research patients provide their informed consent in writing for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. In addition, an IRB at each institution participating in the clinical trial must review and approve the protocolfor any clinical trial including informed consent information before the study commences at that institution. Information about most clinical trials must be submitted within specific timeframes for publication on the www.clinicaltrials.gov website.
Information related to the product, patient population, phase of investigation, study sites and investigators, and other aspects of the clinical trial is made public as part of the registration of the clinical trial. Sponsors are also obligated to discuss the results of their clinical trials after completion. Disclosure of the results of these trials can be delayed in some cases for up to two years after the date of completion of the trial. Competitors may use this publicly available information to gain knowledge regarding the progress of development programs.
Human clinical trials are typically conducted in three sequential phases, which may overlap or be combined:
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Phase 1: The drug is initially introduced into healthy human patients or patients with the target disease or condition and tested for safety, dosage tolerance, pharmacokinetics, absorption, metabolism, distribution, excretion, side effects and, if possible, to gain an early indication of its effectiveness.
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Phase 2: The drug is administered to a limited patient population 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.
In most cases, FDA requires two adequate and well‑controlled Phase 3 clinical trials to demonstrate efficacy of the drug.
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Phase 3: The drug is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well‑controlled clinical trials to generate enough data to statistically evaluate the efficacy and safety of the product for approval, to establish the overall risk‑benefit profile of the product, and to provide adequate information for the labeling of the product.
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Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur. The FDA or the sponsor may suspend or terminate a clinical trial at any time
or the FDA may impose other sanctions
on various grounds, including a finding that the research patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients.
Marketing Approval
Assuming successful completion of the required clinical testing, the results of the non-clinical and clinical studies, together with detailed information relating to the product’s chemistry, manufacture, controls and proposed labeling, among other things, are submitted to the FDA as part of an NDA requesting approval to market the product for one or more indications. In most cases, the submission of an NDA is subject to a substantial application user fee. Under the Prescription Drug User Fee Act, or PDUFA, guidelines that are currently in effect, the FDA has
60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the agency’s threshold determination that the NDA is sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an NDA for filing. In
this event, the application must be resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in‑depth substantive review. The FDA has agreed to certain performance goals in the review of NDAs. Most applications for standard review drug products are reviewed within ten to twelve months; most NDAs for priority review drugs are reviewed in six to eight months. The review process for both standard and priority review may be extended by FDA for three additional months to consider certain late‑submitted information, or information intended to clarify information already provided in the submission. The FDA reviews an NDA to determine, among other things, whether the drug is safe and effective and whether the facility in which it is manufactured, processed, packaged or held meets standards designed to assure the product’s continued safety, quality and purity.
In accordance with the Pediatric Research and Equity Act, certain NDAs or supplements to an NDA must contain data that are adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements.
The FDA also may require submission of a REMS plan
if it determines that a REMS is necessary
to ensure that the benefits of the drug outweigh its risks. The REMS plan could include medication guides, physician communication plans, assessment plans and/or elements to assure safe use, such as restricted distribution methods, patient registries or other risk minimization tools.
The FDA may refer an application for a novel drug, or a drug that presents difficult questions of safety or efficacy, to an advisory committee. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA may inspect one or more clinical trial sites and the sponsor to assure compliance with GCP requirements and the integrity of the clinical data submitted in an NDA.
After evaluating the NDA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing facilities and clinical trial sites, the FDA will issue an approval letter or a complete response letter. A complete response letter generally outlines the deficiencies in the submission and contains a statement of specific conditions that must be met in order to secure final approval of the NDA and may require additional clinical or non-clinical testing in a resubmission to the NDA in order for the FDA to reconsider the application.
FDA has committed to reviewing such submissions in two or six months depending on the type of information included in the resubmission.
Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.
Even if the FDA approves a product, it may limit the approved indications for use of the product, require that contraindications, warnings or precautions be included in the product labeling, require that post‑approval studies, including Phase 4 clinical trials, be conducted to further assess a drug’s safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution and use restrictions or other risk management mechanisms under a REMS, which can materially affect the potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post‑marketing studies or surveillance programs. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval.
Special FDA Expedited Review and Approval Programs
The FDA has various programs, including fast track designation, breakthrough therapy designation, accelerated approval, and priority review, which are intended to expedite or simplify the process for the development and FDA review of drugs that are intended for the treatment of serious or life threatening diseases or conditions and demonstrate the potential to address unmet medical needs. The purpose of these programs is to provide important new drugs to patients earlier than under standard FDA review procedures.
Under the fast track program, the sponsor of a new drug candidate may request that FDA designate the drug candidate for a specific indication as a fast track drug concurrent with, or after, the filing of the IND for the drug candidate.
Fast track designation provides opportunities for frequent interactions with the FDA review team to expedite development and review of the product. FDA may initiate review of sections of a fast track drug’s NDA before the application is complete. This rolling review is available if the applicant provides, and FDA approves, a schedule for the submission of the remaining information and the applicant pays applicable user fees. However, FDA’s time period goal for reviewing an application does not begin until the last section of the NDA is submitted.
In addition, a sponsor can request breakthrough therapy designation for a drug if it is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Drugs designated as breakthrough therapies are eligible for intensive guidance from FDA on an efficient drug development program, organizational commitment to the development and review of the product including involvement of senior managers, and, like fast track products, are also eligible for rolling review of the NDA. Both fast track and breakthrough therapy products are also eligible for accelerated approval and/or priority review, if relevant criteria are met.
Under the FDA’s accelerated approval regulations, the FDA may approve a drug for a serious or life‑threatening illness that provides meaningful therapeutic benefit to patients over existing treatments based upon a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.
In clinical trials, a surrogate endpoint is a measurement of laboratory or clinical signs of a disease or condition that substitutes for a direct measurement of how a patient feels, functions, or survives. Surrogate endpoints can often be measured more easily or more rapidly than clinical endpoints. A drug candidate approved on this basis is subject to rigorous post‑marketing compliance requirements, including the completion of Phase 4 or post‑approval clinical trials to confirm the effect on the clinical endpoint. Failure to conduct required post‑approval studies, or confirm a clinical benefit during post‑marketing studies, will allow FDA to withdraw the drug from the market on an expedited basis. All promotional materials for drug candidates approved under accelerated approval regulations are subject to prior review by FDA.
Once an NDA is submitted for a product intended to treat a serious condition, the FDA may assign a priority review designation if FDA determines that the product, if approved, would provide a significant improvement in safety or effectiveness.
A priority review means that the goal for the FDA to review an application is six months, rather than the standard review of ten months under current PDUFA guidelines. Under the current PDUFA agreement, these six and ten month review periods are measured from the 60-day filing date rather than the receipt date for NDAs for new molecular entities, which typically adds approximately two months to the timeline for review from the date of submission. Most products that are eligible for fast track breakthrough therapy designation are also likely to be considered appropriate to receive a priority review.
Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened. In addition, the manufacturer of an investigational drug for a serious or life‑threatening disease is required to make available, such as by posting on its website, its policy on responding to requests for expanded access. Furthermore, fast track designation, breakthrough therapy designation, accelerated approval and priority
review do not change the standards for approval and may not ultimately expedite the development or approval process.
Post-Approval Requirements
Drugs manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims are subject to prior FDA review and approval. There also are continuing, substantial annual user fee requirements for any marketed products and the establishments at which such products are manufactured, as well as new application fees for supplemental applications with clinical data.
These fees are typically increased annually.
The FDA may impose a number of post‑approval requirements as a condition of approval of an NDA. For example, the FDA may require post‑marketing testing, including Phase 4 clinical trials, and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization.
In addition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and state agencies, and are subject to periodic unannounced inspections by the FDA and state agencies for compliance with cGMP requirements. Changes to the manufacturing process are strictly regulated and often require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP requirements and impose reporting and documentation requirements upon the sponsor and any third‑party manufacturers that the sponsor may decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance.
Once an approval or clearance of a drug is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in mandatory revisions to the approved labeling to add new safety information; imposition of post‑market studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions under a REMS program. Other potential consequences include, among other things:
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restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;
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fines, warning letters or clinical holds on post‑approval clinical trials;
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refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product approvals;
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product seizure or detention, or refusal to permit the import or export of products; or
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injunctions or the imposition of civil or criminal penalties.
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The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off‑label uses, and a company that is found to have improperly promoted off‑label uses may be subject to significant liability.
The Hatch-Waxman Act
Section 505 of the FDCA describes three types of applications that may be submitted to request marketing authorization for a new drug. A 505(b)(1) NDA is an application that contains full reports of investigations of safety and effectiveness. The Hatch‑Waxman Act created two additional marketing pathways under Sections 505(j) and 505(b)(2) of the FDCA. Section 505(j) establishes an abbreviated approval process for generic versions of approved drug products through the submission of an abbreviated new drug application, or ANDA. An
ANDA provides for marketing of a drug product that has the same active ingredients in the same strengths and dosage form as the branded reference drug and has been shown to be bioequivalent to the branded reference drug. ANDA applicants are required to conduct bioequivalence testing to confirm chemical and therapeutic equivalence to the branded reference drug. Generic versions of drugs can often be substituted by pharmacists under prescriptions written for the branded reference drug.
A 505(b)(2) NDA is an application that contains full reports of investigations of safety and effectiveness but where at least some of the information required for approval comes from studies not conducted by or for the applicant. This alternate regulatory pathway enables the applicant to rely, in part, on the FDA’s findings of safety and efficacy for an existing product, or published literature, in support of its application. The FDA may then approve the new product candidate for all or some of the labeled indications for which the branded reference drug has been approved, as well as for any new indication sought by the 505(b)(2) applicant.
The Hatch‑Waxman Act establishes periods of regulatory exclusivity for certain approved drug products. The holder of an NDA may obtain five years of exclusivity upon approval of a new drug containing a new chemical entity, or NCE, that has not been previously approved by the FDA. During the five year exclusivity period, the FDA cannot accept for filing or approve any ANDA seeking approval of a generic version of that drug or any 505(b)(2) NDA for the same active moiety and that relies on the FDA’s findings regarding that drug, except that FDA may accept an application for filing (but still may not approve it) after four years if the follow‑on applicant makes a paragraph IV certification, as described below. The Hatch‑Waxman Act also provides three years of marketing exclusivity to the holder of an NDA for a particular condition of approval, or change to a marketed product, such as a new formulation or new indication for a previously approved product, if one or more new clinical studies (other than bioavailability or bioequivalence studies) was essential to the approval of the application and was conducted/sponsored by the applicant. This three‑year exclusivity period protects against FDA approval of ANDAs and 505(b)(2) NDA for drugs that include the innovation that required the new clinical data.
Upon submission of an ANDA or a 505(b)(2) NDA, an applicant must certify to the FDA, in the opinion of the applicant and to the best of its knowledge (1) that relevant patent information on the referenced drug product has not been submitted to the FDA; (2) that the relevant patent has expired; (3) the date on which the relevant patent expires; or (4) that such patent is invalid, unenforceable or will not be infringed upon by the manufacture, use or sale of the drug product for which the application is submitted. This last certification is known as a paragraph IV certification. If the NDA holder or patent owner(s) files a patent infringement action against the ANDA or 505(b)(2) applicant within 45 days of receipt of the paragraph IV certification, the FDA may not approve the ANDA or 505(b)(2) application until the earlier of (i) 30 months from the receipt of the notice of the paragraph IV certification (generally referred to as the 30 month stay), (ii) the expiration date of the patent(s) listed in the Orange Book for the reference drug product, (iii) the date the court enters a final order or judgment that the patent(s) are invalid, unenforceable and/or not infringed or (iv) such shorter or longer period as may be ordered by a court. Where the ANDA or 505(b)(2) applicant files an application with a paragraph IV certification within the fifth year of the five‑year NCE exclusivity period enjoyed by the NDA holder for the reference branded product, and where patent litigation is brought within 45 days of receipt of notice of the paragraph IV certification, the 30‑month stay will be extended by the amount of time such that 7.5 years will elapse from the date of approval of the original NDA to the expiration of the stay. Thus, approval of an ANDA or 505(b)(2) NDA could be delayed for a significant period of time depending on the patent certification the applicant makes, whether the reference product enjoys NCE exclusivity, and the reference drug sponsor’s decision to initiate patent litigation.
However, an ANDA applicant may be able to submit a section viii statement certifying that its proposed ANDA label does not contain (or carves out) any language regarding the patented method‑of‑use rather than certify to a listed method‑of‑use patent.
Regulation Outside the United States
In the European Economic Area, or EEA, which is composed of the 28 Member States of the European Union plus Norway, Iceland and Liechtenstein, medicinal products can only be commercialized after obtaining a Marketing Authorization, or MA.
There are two types of MAs:
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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, or CHMP, of the European Medicines Agency, or EMA, and which is valid throughout the entire territory of the EEA. The Centralized Procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products and medicinal products that contain 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 products containing a new active substance not yet authorized in the EEA, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public health in the EU. Under the Centralized Procedure 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 the authorization of a medicinal product is of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation. Under the accelerated procedure the standard 210 days review period is reduced to 150 days.
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National MAs, which are issued by the competent authorities of the Member States of the EEA and only cover their respective territory, are available for products not falling within the mandatory scope of the Centralized Procedure. Where a product has already been authorized for marketing in a Member State of the EEA, this National MA can be recognized in another Member State through the Mutual Recognition Procedure. If the product has not received a National MA in any Member State at the time of application, it can be approved simultaneously in various Member States through the Decentralized Procedure.
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Prior to obtaining an MA in the EEA, applicants have to demonstrate compliance with all measures included in a Paediatric Investigation Plan, or PIP, approved by the EEA regulatory agency, covering all subsets of the pediatric population, unless the EEA regulatory agency has granted (1) a product‑specific waiver, (2) a class waiver or (3) a deferral for one or more of the measures included in the PIP.
In the EEA, upon receiving an MA, new chemical entities generally receive eight years of data exclusivity and an additional two years of market exclusivity. If granted, data exclusivity prevents regulatory authorities in the EEA from referencing the innovator’s data to assess a generic application. During the additional two‑year period of market exclusivity, a generic marketing authorization can be submitted, and the innovator’s data may be referenced, but no generic product can be marketed until the expiration of the market exclusivity. However, there is no guarantee that a product will be considered by the EEA regulatory agencies to be a new chemical entity, and products may not qualify for data exclusivity.
Other Healthcare Laws
In addition to FDA restrictions on the marketing of pharmaceutical products, other foreign, federal and state healthcare regulatory laws restrict business practices in the pharmaceutical industry. These laws include, but are not limited to, federal and state anti‑kickback, false claims, data privacy and security, and physician payment and drug pricing transparency laws.
The U.S. federal Anti‑Kickback Statute prohibits, among other things, any person or entity from knowingly and willfully offering, paying, soliciting, receiving or providing any remuneration, directly or indirectly, overtly or covertly, to induce or in return for purchasing, leasing, ordering, or arranging for or recommending the purchase, lease, or order of any good, facility, item or service reimbursable, in whole or in part, under Medicare, Medicaid or other federal healthcare programs. The term “remuneration” has been broadly interpreted to include anything of value. The Anti‑Kickback Statute has been interpreted to apply to arrangements between pharmaceutical and medical device manufacturers on the one hand and prescribers, purchasers, formulary managers and beneficiaries on the other hand. Although there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly. Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases, or recommendations may be subject to scrutiny if they do not meet the requirements of a statutory or regulatory exception or safe harbor. Failure to meet all of the requirements of a particular applicable statutory exception or
regulatory safe harbor does not make the conduct per se illegal under the U.S. federal Anti‑Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case‑by‑case basis based on a cumulative review of all its facts and circumstances. Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the statute has been violated. In addition, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. Moreover, a claim including items or services resulting from a violation of the U.S. federal Anti‑Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. The majority of states also have anti‑kickback laws, which establish similar prohibitions and in some cases may apply to items or services reimbursed by any third‑party payor, including commercial insurers.
The federal false claims and civil monetary penalties laws, including the civil False Claims Act, prohibit, among other things, any person or entity from knowingly presenting, or causing to be presented, a false, fictitious or fraudulent claim for payment to, or approval by, the federal government, knowingly making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government, or knowingly making a false statement to avoid, decrease or conceal an obligation to pay money to the U.S. federal government. A claim includes “any request or demand” for money or property presented to the U.S. government. Actions under the civil False Claims Act may be brought by the Attorney General or as a
qui tam
action by a private individual in the name of the government. Violations of the civil False Claims Act can result in very significant monetary penalties and treble damages. Several pharmaceutical, medical device and other healthcare companies have been prosecuted under these laws for, among other things, allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. Other companies have been prosecuted for causing false claims to be submitted because of the companies’ marketing of products for unapproved (e.g., or off‑label) uses. In addition, the civil monetary penalties statute imposes penalties against any person who is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent. Many states also have similar fraud and abuse statutes or regulations that apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.
Violations of fraud and abuse laws, including federal and state anti‑kickback and false claims laws, may be punishable by criminal and civil sanctions, including fines and civil monetary penalties, the possibility of exclusion from federal healthcare programs (including Medicare and Medicaid), disgorgement and corporate integrity agreements, which impose, among other things, rigorous operational and monitoring requirements on companies. Similar sanctions and penalties, as well as imprisonment, also can be imposed upon executive officers and employees of such companies. Given the significant size of actual and potential settlements, it is expected that the government authorities will continue to devote substantial resources to investigating healthcare providers’ and manufacturers’ compliance with applicable fraud and abuse laws.
The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, created additional federal criminal statutes that prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third‑party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Similar to the U.S. federal Anti‑Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
In addition, there has been a recent trend of increased federal and state regulation of payments made to physicians and certain other healthcare providers. The Affordable Care Act imposed, among other things, new annual reporting requirements through the Physician Payments Sunshine Act for covered manufacturers for certain payments and “transfers of value” provided to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. Failure to submit timely, accurately and completely the required information for all payments, transfers of value and ownership or investment interests may result in civil monetary penalties. Covered manufacturers must submit reports by the 90
th
day of each subsequent calendar year
and the reported information is publically made available on a
searchable website
. In addition, certain states require implementation of compliance programs and compliance with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, impose restrictions on marketing practices and/or require the tracking and reporting of marketing expenditures and pricing information as well as gifts, compensation and other remuneration or items of value provided to physicians and other healthcare professionals and entities.
We may also be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their respective implementing regulations, including the Final HIPAA Omnibus Rule published on January 25, 2013, impose specified requirements relating to the privacy, security and transmission of individually identifiable health information held by covered entities and their business associates. Among other things, HITECH made HIPAA’s security standards directly applicable to “business associates,” defined as independent contractors or agents of covered entities that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity. HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions. In addition, state laws govern 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 requirements, thus complicating compliance efforts.
Similar foreign laws and regulations, which may include, for instance, applicable post‑marketing requirements, anti‑fraud and abuse laws, and implementation of corporate compliance programs and reporting of payments or other transfers of value to healthcare professionals, may apply to us to the extent that any of our product candidates, once approved, are sold in a country other than the United States.
Coverage and Reimbursement
Significant uncertainty exists as to the coverage and reimbursement status of any pharmaceutical product for which we obtain regulatory approval. In the United States and markets in other countries, patients who are prescribed drugs generally rely on third‑party payors to reimburse all or part of the associated healthcare costs. Providers and 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. If approved, sales of serlopitant will depend, in part, on the availability of coverage and adequate reimbursement from third‑party payors. Third‑party payors include government authorities, managed care plans, private health insurers and other organizations.
In the United States, the process for determining whether a third‑party payor will provide coverage for a pharmaceutical product typically is separate from the process for setting the price of such product or for establishing the reimbursement rate that the payor will pay for the product once coverage is approved. With respect to drugs, third‑party payors may limit coverage to specific products on an approved list, also known as a formulary, which might not include all of the FDA‑approved products for a particular indication, or place products at certain formulary levels that result in lower reimbursement levels and higher cost‑sharing obligation imposed on patients. A decision by a third‑party payor not to cover a product could reduce physician utilization of a product. Moreover, a third‑party payor’s decision to provide coverage for a pharmaceutical product does not imply that an adequate reimbursement rate will be approved. Adequate third‑party reimbursement may not be available to enable a manufacturer to maintain price levels sufficient to realize an appropriate return on its investment in product development. Additionally, coverage and reimbursement for products can differ significantly from payor to payor. One third‑party payor’s decision to cover a particular medical product does not ensure that other payors will also provide coverage for the medical product, or will provide coverage at an adequate reimbursement rate. As a result, the coverage determination process usually requires manufacturers to provide scientific and clinical support for the use of their products to each payor separately and is a time‑consuming process.
In the European Union, governments influence the price of products through their pricing and reimbursement rules and control of national health care systems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed to by the government. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost
effectiveness of a particular product to currently available therapies. Other member states allow companies to fix their own prices for medicines, but monitor and control company profits. The downward pressure on health care costs in general, particularly prescription products, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross border imports from low‑priced markets exert a commercial pressure on pricing within a country.
The containment of healthcare costs has become a priority of federal, state and foreign governments, and the prices of pharmaceutical products have been a focus in this effort. Third‑party payors are increasingly challenging the prices charged for medical products and services, examining the medical necessity and reviewing the cost‑effectiveness of pharmaceutical products, in addition to questioning safety and efficacy. If third‑party payors do not consider a product to be cost‑effective compared to other available therapies, they may not cover that product after FDA approval or, if they do, the level of payment may not be sufficient to allow a manufacturer to sell its product at a profit.
Healthcare Reform and Other Potential Changes to Healthcare Laws
The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. For example, in December 2016, the 21st Century Cures Act, or Cures Act, was signed into law. The Cures Act, among other things, is intended to modernize the regulation of drugs and devices and to spur innovation, but its ultimate implementation is unclear.
In addition, in August 2017, the FDA Reauthorization Act was signed into law, which reauthorized the FDA’s user fee programs and included additional drug and device provisions that build on the Cures Act.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability, which would adversely affect our business, prospects, financial condition and results of operations.
A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and other third‑party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medical products and services, implementing reductions in Medicare and other healthcare funding, and applying new payment methodologies. For example, in March 2010, the Affordable Care Act was enacted, which, among other things, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; introduced a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; extended the Medicaid Drug Rebate Program to utilization of prescriptions of individuals enrolled in Medicaid managed care plans; imposed mandatory discounts for certain Medicare Part D beneficiaries as a condition for manufacturers’ outpatient drugs coverage under Medicare Part D; subjected drug manufacturers to new annual fees based on pharmaceutical companies’ share of sales to federal healthcare programs; imposed a new federal excise tax on the sale of certain medical devices; created a new Patient Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; created the Independent Payment Advisory Board, which, once empaneled, will have authority to recommend certain changes to the Medicare program that could result in reduced payments for prescription drugs; and established a Center for Medicare Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending.
Since its enactment, there have been judicial and Congressional challenges to certain aspects of the Affordable Care Act, and we expect there will be additional challenges and amendments to the Affordable Care Act in the future. The Trump administration and members of the U.S. Congress have indicated that they may continue to seek to modify, repeal, or otherwise invalidate all, or certain provisions of, the Affordable Care Act. It is uncertain the extent to which any such changes may impact our business or financial condition.
In addition, we cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. For example, certain policies of the Trump administration may impact our business and industry. Namely, the Trump administration has taken several executive actions, including the issuance of a number of Executive Orders, that could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine regulatory and oversight activities such as implementing statutes through rulemaking, issuance of guidance and review and approval of marketing applications. Notably, on January 30, 2017, President Trump issued an
Executive Order, applicable to all executive agencies, including the FDA, that requires that for each notice of proposed rulemaking or final regulation to be issued in fiscal year 2017, the agency shall identify at least two existing regulations to be repealed, unless prohibited by law. These requirements are referred to as the “two‑for‑one” provisions. This Executive Order includes a budget neutrality provision that requires the total incremental cost of all new regulations in the 2017 fiscal year, including repealed regulations, to be no greater than zero, except in limited circumstances. For fiscal years 2018 and beyond, the Executive Order requires agencies to identify regulations to offset any incremental cost of a new regulation and approximate the total costs or savings associated with each new regulation or repealed regulation. In interim guidance issued by the Office of Information and Regulatory Affairs within the Office of Management and Budget, or OMB, on February 2, 2017, the administration indicates that the “two‑for‑one” provisions may apply not only to agency regulations, but also to significant agency guidance documents. In addition, on February 24, 2017, President Trump issued an executive order directing each affected agency to designate an agency official as a “Regulatory Reform Officer” and establish a “Regulatory Reform Task Force” to implement the two‑for‑one provisions and other previously issued executive orders relating to the review of federal regulations, however it is difficult to predict how these requirements will be implemented, and the extent to which they will impact the FDA’s ability to exercise its regulatory authority. If these executive actions impose constraints on the FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted.
In addition, other legislative changes have been proposed and adopted in the United States since the Affordable Care Act to reduce healthcare expenditures. These changes include the Budget Control Act of 2011, which led to aggregate reductions of Medicare payments to providers of 2% per fiscal year and that will remain in effect through 2025 unless additional action is taken by Congress; the American Taxpayer Relief Act of 2012, which, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years; and the Medicare Access and CHIP Reauthorization Act of 2015, which ended the use of the statutory formula for Medicare payment adjustments to physicians, and provided for a 0.5% annual increase in payment rates under the Medicare Physician Fee Schedule through 2019, but no annual update from 2020 through 2025. More recently, there 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 pharmaceutical products.
Individual states in the United States have also become increasingly aggressive in passing legislation and 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, designed to encourage importation from other countries and bulk purchasing.
Employees
As of December 15, 2017, we had 32 employees. Within our workforce, 23 employees are engaged in research and development and the remaining 9 in general management and administration, including finance and facilities. None of our employees are represented by labor unions or covered by collective bargaining agreements. We believe that we maintain good relations with our employees.
Property and Facilities
Our headquarters is currently located in Redwood City, California, and consists of approximately 13,904 square feet of leased office and laboratory space under a lease that expires in March of 2020. We believe that our existing facilities are adequate for our current needs; however, we may require additional space and facilities as our business expands.
Legal Proceedings
We are not subject to any material legal proceedings.
MANAGEMENT
Executive Officers and Directors
The following table sets forth information regarding our executive officers, directors and key employees as of December 15, 2017:
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Name
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Age
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Position(s)
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Executive Officers and Employee Directors
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Steven Basta
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52
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President, Chief Executive Officer and Director
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Kristine Ball
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45
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Senior Vice President, Corporate Strategy and Chief Financial Officer
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Paul Kwon, M.D.
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47
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Chief Medical Officer
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Key Employees
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Mary Spellman, M.D.
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56
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Senior Vice President, Clinical Development
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Danine Summers
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60
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Senior Vice President, Medical Affairs
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Xiaoming Zhang, Ph.D.
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54
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Senior Vice President, Non‑Clinical and Pharmaceutical Development
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Non-Employee Directors
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Paul Berns
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51
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Director
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Albert Cha, M.D., Ph.D.
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45
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Director
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Ted Ebel
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48
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Director
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David McGirr
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63
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Director
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Aaron Royston, M.D.
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33
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Director
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Scott Whitcup, M.D.
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58
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Director
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Executive Officers and Employee Directors
Steven Basta
has served as our President and Chief Executive Officer and member of our board of directors since September 2015. From October 2011 until August 2015, Mr. Basta served as Chief Executive Officer of AlterG, a privately held medical device company. From November 2002 to February 2010, Mr. Basta served as Chief Executive Officer of BioForm Medical, a publicly listed medical aesthetics company acquired by Merz, and from February 2010 to September 2011 served as Chief Executive Officer of Merz Aesthetics, the successor to BioForm Medical. Mr. Basta served on the board of Carbylan, Inc. from September 2009 to November 2016. Mr. Basta served on the board of RF Surgical, Inc. (acquired by Medtronic) from December 2013 to August 2015. Mr. Basta received a B.A. from The Johns Hopkins University and an M.B.A. from the Kellogg Graduate School of Management at Northwestern University. We believe Mr. Basta is qualified to serve as our President and Chief Executive Officer and on our board of directors because of his extensive experience in leadership and management roles at various life sciences companies.
Kristine Ball
has served as our Senior Vice President, Corporate Strategy and Chief Financial Officer since September 2017. From November 2012 through October 2016, Ms. Ball served as Chief Financial Officer and Senior Vice President of Relypsa, Inc., a publicly‑listed pharmaceutical company acquired by Galenica. Prior to Relypsa, Ms. Ball was an independent consultant from June 2011 to October 2012, advising start‑up life science companies on various strategic and operational business matters. Prior to being a consultant, Ms. Ball was Senior Vice President of Finance and Administration and Chief Financial Officer of KAI Pharmaceuticals,
Inc. (acquired by Amgen), a drug discovery company, from February 2005 to January 2011, where she was responsible for finance, administration and strategic planning and was involved in a venture capital financing, pharmaceutical partnerships and, as a consultant, KAI’s acquisition. Prior to KAI, Ms. Ball served as Vice President of Finance at Exelixis, Inc., a biotechnology company, from 2000 to 2005, where she was involved in four acquisitions and Exelixis’ initial public offering and other financings. Prior to Exelixis, Ms. Ball was a senior manager in Ernst & Young’s life sciences audit practice. Ms. Ball holds a B.S. from Babson College and is a certified public accountant.
Paul Kwon, M.D.
has served as our Chief Medical Officer since January 2016. Dr. Kwon previously served as Chief Medical Officer at Nora Therapeutics, a biotechnology company focused on developing therapeutics to address significant unmet needs in reproductive medicine from November 2010 to November 2015. Prior to joining Nora Therapeutics, Dr. Kwon held numerous positions at Genentech, where he was most recently head of the non‑oncology early clinical development group. Dr. Kwon was in clinical practice as a dermatologist from 2001 to 2003 and from 2009 to 2010 with the Permanente Medical Group in Northern California, where he served as a consultant for the Permanente Technology Group. Dr. Kwon served as Assistant Clinical Professor of Dermatology at the University of California at San Francisco from 2004 to 2014. Dr. Kwon earned his B.A. in Human Biology from Stanford University and an M.D. from the University of California at San Francisco. He is a diplomate of the American Board of Dermatology and a fellow of the American Academy of Dermatology.
Key Employees
Mary Spellman, M.D.
has served as our Senior Vice President, Clinical Development since August 2017. Previously, Dr. Spellman was an independent consultant providing executive level medical, safety and development services to multiple life sciences companies, primarily supporting novel dermatology therapy and clinical development programs from August 2012 to August 2017. Prior to establishing her consulting practice, Dr. Spellman was Chief Medical Officer and Senior Vice President, Development at Revance Therapeutics, as well as Senior Director, Medical Research, Immunology at Biogen Idec, and Vice President, Dermatology Research at Connetics Corporation. Dr. Spellman is a board‑certified dermatologist with over 30 years of clinical experience, including 20 years in the biopharmaceutical industry. Dr. Spellman received a BS, Honors in Biology from Loyola University of Chicago and earned her M.D. from the Medical College of Wisconsin. Sh
e is a diplomate of the American Board of Dermatology and a fellow of the American Academy of Dermatology.
Danine Summers
has served as our Senior Vice President, Medical Affairs since March 2017. Previously, from March 2013 to February 2017, Ms. Summers was Senior Vice President, Medical Affairs at Anacor Pharmaceuticals, where she participated in preparing the organization for two product launches, with responsibility for technology platform and clinical data communication and key opinion leader relationships. From February 2007 to December 2012, Ms. Summers was the Vice President, Medical Affairs for Medicis Pharmaceutical, where she led the organization’s medical information management, publications, educational grants, investigator‑initiated study grants and health economics outcomes research. Ms. Summers has 35 years of experience in the pharmaceutical industry, the last 20 in dermatology specifically. Ms. Summers received a B.A. from San Jose State University and an M.B.A. in Marketing from Golden Gate University.
Xiaoming Zhang, Ph.D.
has served as our Senior Vice President, Non‑Clinical and Pharmaceutical Development since November 2015. Previously, Dr. Zhang was a Venture Partner at Velocity Pharmaceutical Development, where he provided non‑clinical and CMC‑related expertise to several project‑focused companies. In 2010, Dr. Zhang co‑founded Theron Pharmaceuticals, a clinical‑stage company developing a bronchodilator for the treatment of chronic obstructive pulmonary disease and uncontrolled asthma. Prior to Theron, Dr. Zhang was Senior Director of Chemistry at CoMentis, Inc. where he led the research effort targeting Alzheimer’s disease and cognitive deficit associated with schizophrenia. Dr. Zhang previously served in scientific or program leadership roles at Millennium Pharmaceuticals, Portola Pharmaceuticals and Roche. Dr. Zhang received a B.S. from Donghua University, Shanghai and a Ph.D. from the University of Maryland, College Park, in the field of synthetic organic chemistry and pursued postdoctoral research at the University of California, Berkeley.
Non-Employee Directors
Paul Berns
has served as a member of our board of directors since November 2017. Mr. Berns has been a consultant to the pharmaceutical industry since July 2016, as well as from August 2012 to March 2014 and from July 2005 to March 2006. From March 2014 to June 2016,
Mr. Berns served as President and Chief
Executive Officer at Anacor Pharmaceuticals, Inc. a biopharmaceutical company, which was acquired by Pfizer Inc. in 2016. Previously, Mr. Berns served as President and Chief Executive Officer of Allos Therapeutics, Inc., a biopharmaceutical company, from March 2006 to September 2012, when it was acquired by Spectrum Pharmaceuticals, Inc. Mr. Berns was President and Chief Executive Officer of Bone Care International, Inc., a specialty pharmaceutical company, from June 2002 to July 2005, when it was acquired by Genzyme Corporation. Prior to that, Mr. Berns was Vice President and General Manager of the Immunology, Oncology and Pain Therapeutics business unit of Abbott Laboratories from 2001 to 2002, and from 2000 to 2001, he served as Vice President, Marketing of BASF Pharmaceuticals/Knoll, when it was acquired by Abbott Laboratories in 2001. Earlier in his career, Mr. Berns held various positions, including senior management roles, at Bristol-Myers Squibb Company from 1990 to 2000. Mr. Berns is currently a board member of the privately held company, MC2 Therapeutics (since May 2017), and the publicly held company, Jazz Pharmaceuticals, PLC (since April 2010). Mr. Berns previously served on the boards of Anacor Pharmaceuticals, Inc. (from June 2012 to June 2016), XenoPort, Inc. (from November 2005 to May 2016), Allos Therapeutics, Inc. (from March 2006 to September 2012) and Bone Care International, Inc. (from June 2002 to July 2005). Mr. Berns received his B.S. in Economics from the University of Wisconsin. We believe that Mr. Berns is qualified to serve on our board of directors because of his extensive experience in the biopharmaceutical industry and his service as a director of a number of public pharmaceutical companies.
Albert Cha, M.D., Ph.D.
has served as a member of our board of directors since November 2015. In 2000, Dr. Cha joined Vivo Capital, a healthcare investment firm, where he has served in various positions, and he currently serves as a Managing Partner. Dr. Cha currently serves as a member of the boards of directors of several publicly and privately held biotechnology and medical device companies, including the following publicly listed companies: Ascendis Pharma A/S (since November 2014), Biohaven Pharmaceutical Holding Co. Ltd. (since February 2017) and KalVista Pharmaceuticals (since 2007). Dr. Cha was a board member of AirXpanders, Inc. from January 2012 to July 2016, a board member of Aclaris Therapeutics from August 2012 to August 2016, and a board member of Sierra Oncology, Inc. from August 2014 to June 2016. Dr. Cha holds B.S. and M.S. degrees in Electrical Engineering from Stanford University and an M.D. degree and Ph.D. degree in Neuroscience from the University of California at Los Angeles. We believe that Dr. Cha’s substantial experience with companies in the healthcare sector and his financial and business experience qualify him to serve as a director of our Company.
Ted Ebel
has served as a member of our board of directors since March 2014. Mr. Ebel has served as Chief Business Officer at Colorescience since March 2013. Prior to that, he was Senior Vice President of Corporate Development for SkinMedica, Inc. from March 2006 to December 2012, having responsibility for mergers and acquisitions, licensing, intellectual property management, market research and establishing the company’s international operations. Previously, Mr. Ebel served as the Executive Director of Corporate Development at CancerVax Corporation, a biotechnology company focused on cancer immunotherapy, and as the Vice President of Strategic Ventures for MP3.com, a publicly traded internet and entertainment company. In addition, Mr. Ebel held positions in marketing and corporate development at Amgen, Inc. and began his career as a consultant in the health care practice of the management consulting firm Arthur D. Little. Mr. Ebel earned an A.B., Magna Cum Laude from Duke University and his M.B.A. from the Wharton School at the University of Pennsylvania. We believe that Mr. Ebel is qualified to serve on our board of directors because of his background working in the dermatology industry and his experience in strategic planning, business transactions, sales operations and executive leadership.
David McGirr
has served as a member of our board of directors since November 2017. From March 2013 until June 2014,
Mr. McGirr was Senior Advisor to the Chief Executive Officer of Cubist Pharmaceuticals, Inc., a biopharmaceutical company, where he also served as Senior Vice President and Chief Financial Officer from November 2002 to March 2013. Prior to that, Mr. McGirr was the President and Chief Operating Officer of hippo inc., a venture-financed internet technology company, where Mr. McGirr also served as a member of its board of directors from 1999 to 2003. Previously, Mr. McGirr was the President of GAB Robins North America, Inc., a risk management company, serving also as Chief Executive Officer from 1997 to 1999. Prior to that, Mr. McGirr was a private equity investor from 1995 to 1996. Earlier in his career, Mr. McGirr served in various positions within the S.G. Warburg Group from 1978 to 1995, ultimately as Chief Financial Officer, Chief Administrative Officer and Managing Director of S.G. Warburg & Co., Inc., a position held from 1992 to 1995. Mr. McGirr is currently a board member of the following publicly listed companies: Arsanis, Inc. (since September 2017), Insmed Incorporated (since October 2013), Rhythm Pharmaceuticals, Inc. (since November
2015) and Roka Bioscience, Inc. (since December 2013) and previously served on the boards of LifeCell Corporation (from November 2007 to June 2008) and Relypsa, Inc. (from November 2012 to September 2016). Mr. McGirr received his B.Sc. in Civil Engineering from the University of Glasgow and his M.B.A. from The Wharton School at the University of Pennsylvania. We believe that Mr. McGirr is qualified to serve on our board of directors because of his experience as an executive officer or director of a number of public and private pharmaceutical companies.
Aaron Royston, M.D.
has served as a member of our board of directors since July 2017. Dr. Royston has served as a Partner at venBio, a life sciences investment firm, which he joined in November 2015. Prior to joining venBio, Dr. Royston worked for Vivo Capital, a global life sciences investment firm from July 2014 to October 2015. Previously, he worked at Bain & Company from July 2013 to July 2014, where he advised biotechnology companies on a broad range of strategic and operational issues. Earlier in his career, Dr. Royston coordinated clinical research at Mount Sinai Medical Center, where his research has been published and presented in multiple medical journals and conferences. Dr. Royston received his B.S. in biological sciences from Duke University, and his M.D. and M.B.A. degrees from the University of Pennsylvania. In 2011, Dr. Royston was recognized by the Obama Administration as a Champion of Change for his work in technology and innovation. We believe that Dr. Royston is qualified to serve on our board of directors due to his clinical and biotechnology industry experience.
Scott Whitcup, M.D.
has served as a member of our board of directors since February 2016. Dr. Whitcup is founder and Chief Executive Officer of Akrivista and Whitecap Biosciences, two companies focused on the development and commercialization of novel therapies in ophthalmology and dermatology. Previously, Dr. Whitcup held various research and development roles from 2000 to 2015 at Allergan, including serving as Executive Vice President, Research and Development and Chief Scientific Officer, where he led the discovery and global development of both pharmaceutical products and medical devices in therapeutic areas including ophthalmology, CNS, urology, dermatology, medical aesthetics and surgical obesity. Before Allergan, Dr. Whitcup was the Clinical Director at the National Eye Institute at the NIH, and Chaired the NIH Medical Executive Committee. Dr. Whitcup holds a B.A. in Neurobiology and Behavior from Cornell University and an M.D. from Cornell University Medical College. Dr. Whitcup has completed a residency in Internal Medicine at UCLA, a residency in Ophthalmology at Harvard Medical School‑Massachusetts Eye & Ear Infirmary and a fellowship in Uveitis and Ocular Immunology at the National Eye Institute, National Institutes of Health. He is a Diplomate of both the American Board of Internal Medicine and the American Board of Ophthalmology, a licensed M.D. in California and is on the Clinical Faculty of the Department of Ophthalmology, at the Jules Stein Eye Institute, David Geffen School of Medicine at the University of California at Los Angeles. Dr. Whitcup has published more than 250 scientific articles and co‑authored a leading textbook on uveitis and ocular immunology. Dr. Whitcup currently serves on the boards of Semnar Pharmaceutical and Nightstar Therapeutics and previously served on the board of Avanir Pharmaceutical, a publicly listed company, from November 2005 to January 2014. We believe that Dr. Whitcup is qualified to serve on our board of directors due to his clinical development expertise, medical and scientific expertise and his leadership experience with life sciences companies.
Board Composition
Director Independence
Our board of directors currently consists of seven members. Our board of directors has determined that all of our directors, other than Mr. Basta, qualify as “independent” directors in accordance with the Nasdaq Global Market listing requirements. The Nasdaq Global Market’s independence definition includes a series of objective tests, such as that the director is not, and has not been for at least three years, one of our employees and that neither the director nor any of his or her family members has engaged in various types of business dealings with us. In addition, as required by the Nasdaq Global Market rules, our board of directors has made a subjective determination as to each independent director that no relationships exists that, in the opinion of our board of directors, would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. In making these determinations, our board of directors reviewed and discussed information provided by the directors and us with regard to each director’s business and personal activities and relationships as they may relate to us and our management. There are no family relationships among any of our directors or executive officers.
Classified Board of Directors
In accordance with our amended and restated certificate of incorporation to be in effect immediately prior to the closing of this offering, our board of directors will be divided into three classes with staggered, three‑year terms. At each annual meeting of stockholders, the successors to directors whose terms then expire will be elected to serve from the time of election and qualification until the third annual meeting following election. Effective upon the closing of this offering, we expect that our directors will be divided among the three classes as follows:
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the Class I directors will be Drs. Cha and Royston and their terms will expire at the annual meeting of stockholders to be held in 2019;
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the Class II directors will be Messrs. Ebel and Berns, and their terms will expire at the annual meeting of stockholders to be held in 2020; and
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the Class III directors will be Messrs. Basta and McGirr and Dr. Whitcup, and their terms will expire at the annual meeting of stockholders to be held in 2021.
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Our amended and restated certificate of incorporation will provide that the authorized number of directors may be changed only by resolution of the board of directors. Any additional directorships resulting from an increase in the number of directors will be distributed among the three classes so that, as nearly as possible, each class will consist of one‑third of the directors. The division of our board of directors into three classes with staggered three‑year terms may delay or prevent a change of our management or a change in control of our company.
Our directors were elected to and currently serve on the board of directors pursuant to a voting agreement among us and several of our largest stockholders. This agreement will terminate upon the closing of this offering, after which there will be no further contractual obligations regarding the election of our directors.
Leadership Structure of the Board
Our amended and restated bylaws and corporate governance guidelines, which will become effective immediately prior to the completion of this offering, will provide our board of directors with flexibility to designate the position of Chairman of the board of directors, and if so, to combine or separate the positions of Chairman of the board of directors and Chief Executive Officer, or to implement a lead director in accordance with its determination that utilizing a particular structure would be in the best interests of our company.
Our board of directors has concluded that our current leadership structure is appropriate at this time. Our board of directors periodically reviews our leadership structure and may make changes in the future as it deems appropriate.
Role of Board in Risk Oversight Process
Risk assessment and oversight are an integral part of our governance and management processes. Our board of directors encourages management to promote a culture that incorporates risk management into our corporate strategy and day‑to‑day business operations. Management discusses strategic and operational risks at regular management meetings, and conducts specific strategic planning and review sessions during the year that include a focused discussion and analysis of the risks facing us. Throughout the year, senior management reviews these risks with the board of directors at regular board meetings as part of management presentations that focus on particular business functions, operations or strategies, and presents the steps taken by management to mitigate or eliminate such risks.
Our board of directors does not have a standing risk management committee, but rather administers this oversight function directly through our board of directors as a whole, as well as through various standing committees of our board of directors that address risks inherent in their respective areas of oversight. While our board of directors is responsible for monitoring and assessing strategic risk exposure, our audit committee is responsible for overseeing our major financial risk exposures and the steps our management has taken to monitor and control these exposures. The audit committee also monitors compliance with legal and regulatory requirements and considers and approves or disapproves any related person transactions. Our nominating and corporate governance committee monitors the effectiveness of our corporate governance guidelines. Our compensation committee assesses and monitors whether any of our compensation policies and programs has the potential to encourage excessive risk‑taking.
Board Committees
Audit Committee
Our audit committee oversees our corporate accounting and financial reporting process. Among other matters, the audit committee:
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▪
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appoints our independent registered public accounting firm;
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▪
|
evaluates the independent registered public accounting firm’s qualifications, independence and performance;
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▪
|
determines the engagement of the independent registered public accounting firm;
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▪
|
reviews and approves the scope of the annual audit and the audit fee;
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▪
|
discusses with management and the independent registered public accounting firm the results of the annual audit and the review of our quarterly financial statements;
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▪
|
approves the retention of the independent registered public accounting firm to perform any proposed permissible non‑audit services;
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▪
|
monitors the rotation of partners of the independent registered public accounting firm on our engagement team in accordance with requirements established by the SEC;
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▪
|
is responsible for reviewing our financial statements and our management’s discussion and analysis of financial condition and results of operations to be included in our annual and quarterly reports to be filed with the SEC;
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▪
|
reviews our critical accounting policies and estimates; and
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▪
|
reviews the audit committee charter and the committee’s performance at least annually.
|
The current members of our audit committee are Messrs. McGirr, Berns and Ebel, with Mr. McGirr serving as the chairperson of the committee. All members of our audit committee meet the requirements for financial literacy under the applicable rules and regulations of the SEC and the Nasdaq Global Market. Our board of directors has determined that Mr. McGirr is an audit committee financial expert as defined under the applicable rules of the SEC and has the requisite financial sophistication as defined under the applicable rules and regulations of the Nasdaq Global Market. Under the rules of the SEC, members of the audit committee must also meet heightened independence standards.
However, so long as at least one member of the audit committee satisfies the heightened audit committee independence standards on the date of the effectiveness of the registration statement of which this prospectus forms a part, a majority of members of the audit committee may be exempt from the heightened audit committee independence standards for 90 days from such date and a minority of members of the audit committee may be exempt from the heightened audit committee independence standards for one year from such date.
Our board of directors has determined that Messrs. McGirr, Berns and Ebel are independent under the applicable rules of the SEC and the Nasdaq Global Market. Upon completion of this offering the audit committee will operate under a written charter that satisfies the applicable standards of the SEC and the Nasdaq Global Market.
Compensation Committee
Our compensation committee oversees policies and makes determinations relating to compensation and benefits of our current and prospective officers, directors and employees.
The compensation committee annually evaluates the performance of our company, and where appropriate, our officers, in light of the goals and objectives it has established, and determines and approves, or may recommend to the board of directors to approve, the bonus award, if any, payable to these officers. The compensation committee may establish compensation and make bonus awards to our chief executive officer directly or may make recommendations to the board of directors regarding compensation and bonus awards payable to our chief executive officer. Our compensation committee also reviews director compensation and may set director compensation or make recommendations to the board of directors regarding director compensation.
The compensation committee also reviews and approves or makes recommendations to our board of directors regarding the issuance of stock
options and other awards under our stock plans. The compensation committee will review and evaluate, at least annually, the performance of the compensation committee and its members, including compliance by the compensation committee with its charter. The current members of our compensation committee are Dr. Cha and Messrs. Ebel and McGirr, with Mr. Ebel serving as the chairman of the committee. Our board of directors has determined that each of Dr. Cha and Messrs. Ebel and McGirr is independent under the applicable rules and regulations of the Nasdaq Global Market, is a “non‑employee director” as defined in Rule 16b‑3 promulgated under the Exchange Act and is an “outside director” as that term is defined in Section 162(m) of the U.S. Internal Revenue Code of 1986, as amended, or Section 162(m). Upon completion of this offering, the compensation committee will operate under a written charter that satisfies the applicable standards of the SEC and the Nasdaq Global Market.
Nominating and Corporate Governance Committee
Our nominating and corporate governance committee is responsible for making recommendations to our board of directors regarding candidates for directorships and the size and composition of our board of directors. In addition, the nominating and corporate governance committee is responsible for overseeing our corporate governance policies and reporting and making recommendations to our board of directors concerning governance matters. The members of our nominating and corporate governance committee are Drs. Royston and Whitcup and Mr. Berns, with Dr. Whitcup serving as the chairman of the committee. Our board of directors has determined that each of Drs. Royston and Whitcup and Mr. Berns is an independent director under the applicable rules and regulations of the Nasdaq Global Market relating to nominating and corporate governance committee independence. The nominating and corporate governance committee operates under a written charter that satisfies the applicable standards of the SEC and the Nasdaq Global Market.
Compensation Committee Interlocks and Insider Participation
During the year ended
December 31, 2016
, our compensation committee consisted of Dr. Cha and Mr. Ebel. None of the members of our compensation committee during 2016 nor any of the current members of our compensation committee has at any time been one of our officers or employees. An affiliate of Dr. Cha, Vivo Capital VIII, L.P., has participated in multiple of our equity financing rounds. For more information regarding these transactions, see “Certain Relationships and Related Party Transactions”. None of our executive officers currently serves, or in the past fiscal year has served, as a member of the board of directors or compensation committee of any entity that has one or more executive officers on our board of directors or compensation committee.
Board Diversity
Upon completion of this offering, our nominating and corporate governance committee will be responsible for reviewing with the board of directors, on an annual basis, the appropriate characteristics, skills and experience required for the board of directors as a whole and its individual members. In evaluating the suitability of individual candidates (both new candidates and current members), the nominating and corporate governance committee, in recommending candidates for election, and the board of directors, in approving (and, in the case of vacancies, appointing) such candidates, may take into account many factors, including but not limited to the following:
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▪
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personal and professional integrity;
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▪
|
experience in corporate management, such as serving as an officer or former officer of a publicly held company;
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▪
|
experience in the pharmaceutical industry;
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▪
|
experience as a board member or executive officer of another publicly held company;
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▪
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diversity of expertise and experience in substantive matters pertaining to our business relative to other board members;
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▪
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conflicts of interest; and
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▪
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practical and mature business judgment.
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Currently, our board of directors evaluates, and following the completion of this offering will evaluate, each individual in the context of the board of directors as a whole, with the objective of assembling a group that can best maximize the success of the business and represent stockholder interests through the exercise of sound judgment using its diversity of experience in these various areas.
Code of Business Conduct and Ethics
Prior to the completion of this offering, we will adopt a code of business conduct and ethics that will apply to all of our employees, officers and directors, including those officers responsible for financial reporting. Following the completion of this offering, the code of business conduct and ethics will be available on our website at www.menlotherapeutics.com. We expect that any amendments to the code, or any waivers of its requirements, will be disclosed on our website. The reference to our web address does not constitute incorporation by reference of the information contained at or available through our website.
Limitation on Liability and Indemnification Matters
Our amended and restated certificate of incorporation, which will become effective immediately prior to the
completion
of this offering, will contain provisions that limit the liability of our directors for monetary damages to the fullest extent permitted by Delaware law. Consequently, our directors will not be personally liable to us or our stockholders for monetary damages for any breach of fiduciary duties as directors, except liability for:
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▪
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any breach of the director’s duty of loyalty to us or our stockholders;
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▪
|
any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;
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▪
|
unlawful payments of dividends or unlawful stock repurchases or redemptions as provided in Section 174 of the Delaware General Corporation Law; or
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▪
|
any transaction from which the director derived an improper personal benefit.
|
Each of our amended and restated certificate of incorporation and amended and restated bylaws, which will become effective immediately prior to the
completion
of this offering, will provide that we are required to indemnify our directors and officers, in each case to the fullest extent permitted by Delaware law. Our amended and restated bylaws will also obligate us to advance expenses incurred by a director or officer in advance of the final disposition of any action or proceeding, and permit us to secure insurance on behalf of any officer, director, employee or other agent for any liability arising out of his or her actions in that capacity regardless of whether we would otherwise be permitted to indemnify him or her under Delaware law. We have entered and expect to continue to enter into agreements to indemnify our directors, executive officers and other employees as determined by our board of directors. With specified exceptions, these agreements provide for indemnification for related expenses including, among other things, attorneys’ fees, judgments, fines and settlement amounts incurred by any of these individuals in any action or proceeding. We believe that these bylaw provisions and indemnification agreements are necessary to attract and retain qualified persons as directors and officers. We also maintain directors’ and officers’ liability insurance.
The limitation of liability and indemnification provisions in our amended and restated certificate of incorporation and amended and restated bylaws may discourage stockholders from bringing a lawsuit against our directors and officers for breach of their fiduciary duty. They may also reduce the likelihood of derivative litigation against our directors and officers, even though an action, if successful, might benefit us and our stockholders. Further, a stockholder’s investment may be adversely affected to the extent that we pay the costs of settlement and damage.
Director Compensation
Our board of directors has adopted the following compensation policy that is applicable to all of our non-employee directors upon completion of the offering:
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▪
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Initial Equity Grants.
Each non-employee director who joins the board after the completion of the offering will receive an option to purchase common stock with a Black-Scholes value of $180,000, with the shares subject to the option vesting in three equal installments on each anniversary of the director’s service, subject to continued service.
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▪
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Annual Retainers.
At each annual meeting of stockholders, each non-employee director who has served in such capacity for at least six months will receive an additional retainer for service on the board consisting of an option to purchase common stock with a Black-Scholes value of $90,000, with the shares subject to the option vesting one year after the grant date, subject to continued service. In addition, each of our non-employee directors will receive an annual cash retainer of $40,000, and our non-employee directors will also receive annual cash compensation for service as chair of our board of directors or as lead independent director, if such positions are appointed, or as a member or chair of committees of our board of directors, as set forth in the table below:
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Additional annual retainer fees for service as Chair of the Board
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$40,000
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Additional annual retainer fees for service as Lead Independent Director
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$25,000
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Additional annual retainer fees for service as a member or chair of
(with chair fees inclusive of fees for service as a member):
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Member
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Chair
|
Audit Committee
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$8,000
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$16,000
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Compensation Committee
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$6,000
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$12,000
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Nominating and Corporate Governance Committee
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$4,000
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$8,000
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The exercise price per share of each option granted under this policy will be equal to the per share fair market value of our stock on the date of grant. Each such option will have a term of ten years from the date of grant, subject to earlier termination in connection with a termination of the non-employee director’s service with us. In the event of a change of control transaction, any unvested portion of an equity award granted under this policy will fully vest and become exercisable immediately prior to the effective date of such transaction, subject to the non-employee director’s continuous service with us on the effective date of such transaction. Cash retainers will be paid on a quarterly basis in arrears, pro-rated based on the days served in the applicable fiscal quarter.
In addition, none of our non-employee directors shall in any event be permitted to receive cash and equity-based compensation exceeding, in the aggregate, $500,000 in any calendar year.
Our director compensation policy was adopted by our board of directors in consideration of a number of factors, including its assessment of a director compensation report from Compensia, which our board of directors engaged to prepare a competitive assessment of non-employee director compensation. The Compensia report delivered to our board of directors in December 2017 recommended a director compensation program based on the 50
th
percentile of a comparator group. In November 2017, our board of directors adopted a policy, which will remain in place until completion of the offering, to pay each non-employee director, excluding those affiliated with principal investors in our company, an annual cash retainer of $25,000 and to grant each such non-employee director an option to purchase 116,750 shares of our common stock upon joining our board of directors. In accordance with the policy, in November 2017, we granted each of Messrs. McGirr and Berns an option to purchase 116,750 shares of our common stock at an exercise price of $2.60 per share. The options granted to Messrs. McGirr and Berns each vest as to 1/4th of the shares underlying such option on the first anniversary of the vesting commencement date and as to 1/48th of such shares underlying the option on each monthly anniversary of the vesting commencement date thereafter, subject to the director’s continued service to us through the applicable vesting date. In addition, Mr. Ebel was granted an option in November 2017 to
purchase 24,540 shares of common stock at an exercise price of $2.60 per share to bring his compensation in line with the non-employee director compensation policy. The options granted to Mr. Ebel vest in equal monthly installments over four years from the date of grant, subject to the director’s continued service to us through the applicable vesting date.
Prior to the adoption of these non-employee director compensation policies, we did not have a formalized non-employee director compensation program. We granted Mr. Ebel a restricted stock purchase award for 33,330 shares of common stock in August 2014, along with an annual cash retainer of $20,000, payable quarterly, in consideration for his becoming a member of, and rendering services to, our board of directors. The restricted stock vests monthly over four years from the vesting commencement date of March 18, 2014, subject to Mr. Ebel’s continued service to us through the end of the vesting period.
Additionally, in connection with their services as directors, in February 2016, we granted each of Dr. Whitcup and Mr. Ebel an option to purchase 329,000 and 49,000 shares of common stock, respectively. The options granted to Dr. Whitcup and Mr. Ebel have an exercise price of $0.68 per share and vest monthly over four years from the respective vesting commencement dates of December 10, 2015, and February 2, 2016. We also reimburse all of our non‑employee directors for all reasonable and customary business expenses incurred in the performance of their duties to us in accordance with Company policy.
In August 2017, we granted Dr. Whitcup and Mr. Ebel’s refresh option awards with respect to 39,480 and 9,880 shares, respectively, in connection with their continued service as directors. The awards have an exercise price of $1.79 per share and vest monthly over four years from the vesting commencement date of August 24, 2017.
In addition, from time to time, we have compensated directors for additional services provided outside their role as director. For example, during
2016, we entered into a consulting agreement with Dr. Collier, a former member of our board of directors, pursuant to which Dr. Collier provides certain advisory and support services in exchange for options to purchase 84,942 shares of our common stock, with an exercise price of $0.68 per share.
The option granted to Dr. Collier vests in two equal tranches. The first tranche of 42,471 shares vests in equal monthly installments over the 48 months commencing on March 8, 2016, and the second tranche of 42,471 shares vests in equal monthly installments over the 12 months commencing on August 10, 2016, the date we entered into the Collaboration Agreement with JT Torii, in each case subject to Dr. Collier’s continued service to us through the vesting date.
We also reimburse all of our non-employee directors for all reasonable and customary business expenses in accordance with Company policy.
Director Compensation Table
The following table sets forth information for the fiscal year ended
December 31, 2016
regarding the compensation awarded to, earned by or paid to our non‑employee directors:
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Name
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Fees Earned or Paid
in Cash ($)
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Option
Awards ($)
(1) (2)
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Total ($)
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Albert Cha, M.D., Ph.D.
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—
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—
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—
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David Collier, M.D.
(3)
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—
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128,351
(4)
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128,351
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John Creecy
(5)
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—
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—
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—
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Ted Ebel
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20,000
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20,466
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40,466
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Aaron Royston, M.D.
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—
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—
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—
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Scott Whitcup, M.D.
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—
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136,952
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136,952
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(1)
|
The amounts reported in the Option Awards column represent the grant date fair value of the stock options granted to the non‑employee members of our board of directors during 2016 as computed in accordance with ASC 718. The assumptions used in calculating the grant date fair value of the stock options reported in the Option Awards column are set forth in Note 8 to the audited financial statements included in this prospectus. Note that the amounts reported in this column reflect the accounting cost for these stock options, and do not correspond to the actual economic value that may be received by the non‑employee members of our board of directors from the options.
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(2)
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As of December 31, 2016, our non‑employee directors held options to purchase the following number of shares of our common stock: Dr. Collier: 84,942 shares, Mr. Ebel: 49,000 shares, and Dr. Whitcup: 329,000. In addition, Mr. Ebel held 33,330 shares of restricted stock which vest in equal installments through March 18, 2018, subject to Mr. Ebel’s continued service to us through the applicable vesting date.
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(3)
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David Collier, M.D. is a former member of our board of directors.
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(4)
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Paid in accordance with a consulting agreement between Dr. Collier and us for services provided outside his role as a director, pursuant to which Dr. Collier received an option to purchase 84,942 shares of common stock, with an exercise price of $0.68 per share, subject to the vesting requirements described above, in exchange for Dr. Collier’s provision of certain advisory and support services to us.
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(5)
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John Creecy is a former member of our board of directors.
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EXECUTIVE COMPENSATION
The following is a discussion of compensation arrangements of our named executive officers, or NEOs. As an “emerging growth company” as defined in the JOBS Act, we are not required to include a Compensation Discussion and Analysis section and have elected to comply with the scaled disclosure requirements applicable to emerging growth companies.
Our Chief Executive Officer and our other executive officer for the year ended
December 31, 2016
were:
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Steven Basta, President and Chief Executive Officer; and
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▪
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Paul Kwon, M.D., Chief Medical Officer.
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We refer to these executive officers in this prospectus as our named executive offi cers, or NEOs. Kristine Ball was hired as our Senior Vice President, Corporate Strategy and Chief Financial Officer in September 2017 and is currently an executive officer, but in accordance with the regulations of the SEC, we have not included her compensation information.
Summary Compensation Table
The following table shows information regarding the compensation of our named executive officers for services performed in the year ended
December 31, 2016
.
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Name and Principal Position
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Year
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Salary
($)
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Bonus
($)(1)
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Option
Awards
($)(2)
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Non-Equity
Incentive Plan
Compensation ($)
|
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All Other
Compensation ($)
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Total ($)
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Steven Basta
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2016
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555,900
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—
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419,417
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|
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—
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|
|
—
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|
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975,317
|
|
President and Chief Executive Officer
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Paul Kwon, M.D.
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2016
|
|
328,125
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|
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98,115
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|
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193,217
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|
|
—
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|
|
—
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619,457
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|
Chief Medical Officer
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(1)
|
Bonus represents amounts earned for 2016 performance and paid in 2017. Mr. Basta was not eligible for a bonus payment for 2016 performance.
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(2)
|
The amounts reported in the option awards column represent the grant date fair value of the stock options granted to our named executive officers during 2016 as computed in accordance with ASC 718. The assumptions used in calculating the grant date fair value of the stock options reported in the option awards column are set forth in Note 8 to the audited financial statements included in this prospectus. Note that the amounts reported in this column reflect the accounting cost for these stock options, and do not correspond to the actual economic value that may be received by our named executive officers from the options.
Our named executive officers will only realize compensation to the extent the trading price of our common stock is greater than the exercise price of such stock options.
|
Outstanding Equity Awards at Fiscal Year End
The following table sets forth all outstanding equity awards held by each of the named executive officers as of
December 31, 2016
.
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Option Awards
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Stock Awards
|
Name
|
|
Vesting
Commencement
Date
(1)
|
|
Number of
Securities
Underlying
Unexercised
Options
Exercisable
(#)
|
|
Number of
Securities
Underlying
Unexercised
Options
Unexercisable
(#)
|
|
Option
Exercise
Price
($)
|
|
Option
Expiration
Date
|
|
Number
of
Shares
or Units
of Stock
That
Have
Not
Vested
(#)(2)
|
|
Market
Value of
Shares
or Units
of Stock
That
Have
Not
Vested
($)(4)
|
|
Equity
Incentive
Plan
Awards:
Number
of
Unearned
Shares,
Units or
Other
Rights
That
Have Not
Vested
(#)
|
|
Equity
Incentive
Plan
Awards:
Market
or Payout
Value of
Unearned
Shares,
Units or
Other
Rights
That
Have Not
Vested
(#)
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Steven Basta
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|
9/1/2015
|
(2)
|
—
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|
|
—
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|
|
0.115
|
|
|
9/8/2025
|
|
588,638
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|
994,797
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|
|
—
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|
|
—
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|
|
|
11/30/2015
|
(3)
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285,052
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|
767,448
|
|
|
0.68
|
|
|
2/2/2026
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Paul Kwon, M.D.
|
|
1/25/2016
|
|
—
|
|
|
460,550
|
|
|
0.68
|
|
|
2/2/2026
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
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|
|
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(1)
|
Except as otherwise noted, options and restricted stock grants vest and, if applicable, become exercisable as to 1/4th of the shares underlying the option or restricted stock grant on the first anniversary of the vesting commencement date and as to 1/48th of the shares underlying the option or restricted stock grant on each monthly anniversary of the vesting commencement date thereafter, subject to the holder continuing to provide services to us through such vesting date.
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(2)
|
Constitutes 856,200 shares of restricted stock that were issued upon exercise of an immediately exercisable stock option for $0.115 per share, of which 588,638 shares remain subject to repurchase by us at the original purchase price in the event Mr. Basta ceases to provide services to us prior to completion of vesting. The remaining shares of restricted stock vest in equal monthly installments through September 1, 2019.
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(3)
|
Option award is exercisable immediately, subject to a repurchase right in favor of the Company which lapses as the option vests. Accordingly, the disclosure in the table above reflects the extent to which this stock option held by Mr. Basta was vested (as opposed to exercisable) as of December 31, 2016. This option award vests and, if applicable, becomes exercisable as to 1/48th of the shares underlying the award on each monthly anniversary of the vesting commencement date thereafter, subject to the holder continuing to provide services to us through such vesting date.
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|
(4)
|
Amounts are calculated by multiplying the number of shares shown in the table by $1.69, the fair market value of our common stock as of December 31, 2016.
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Narrative to Summary Compensation Table and Outstanding Equity Awards at Fiscal Year End
We have entered into agreements with each of our named executive officers in connection with his or her employment with us. These agreements set forth the terms and conditions of employment of each NEO, including base salary, initial equity award grants and standard employee benefit plan participation. Our board of directors or the compensation committee reviews each NEO’s base salary and other compensation from time to time to ensure compensation adequately reflects the NEO’s qualifications, experience, role and responsibilities.
2016 Salaries
For fiscal year 2016, Mr. Basta’s annual base salary was $555,900 and Dr. Kwon’s annual base salary was $350,000.
Terms and Conditions of 2016 Annual Bonuses
Dr. Kwon’s target bonus opportunity is expressed as a percentage of base salary that can be achieved by meeting corporate objectives at a target level. The 2016 annual bonus for Dr. Kwon was targeted at 30% of his base salary. Mr. Basta was not eligible for a bonus payment for 2016 performance.
For 2016, Dr. Kwon was eligible to earn his annual bonus pursuant to the achievement of certain performance goals. The performance goals for annual bonuses are reviewed and approved annually by the compensation committee of our board of directors. Following a review of the corporate goals attained in 2016, the compensation committee awarded Dr. Kwon 100% of his target bonus for the fiscal year 2016.
2016 Equity Award Grants
Both of our NEOs received options to purchase our common stock in fiscal year 2016. See the table above entitled “Outstanding Equity Awards at Fiscal Year End” regarding equity awards made in the past fiscal year to our NEOs.
In accordance with Mr. Basta’s option agreement and offer letter, on the date of a “Change in Control” transaction (as defined in
the 2011 Stock Incentive Plan, or the “2011 Plan”
), vesting will accelerate with respect to 100% of the restricted stock that Mr. Basta holds immediately prior to the Change in Control transaction.
In accordance with our standard form option agreement and form option grant notice, (i) in connection with an Acquisition Event (as defined in the 2011 Plan), each option granted to Dr. Kwon that
is scheduled to vest and, if applicable, become exercisable, on or after the twelve month anniversary of such Acquisition Event (ignoring, for this purpose, any accelerated vesting provisions) shall instead vest and, if applicable, become exercisable on the date of such twelve month anniversary
, subject to the absence of a Termination (as defined in the 2011 Plan) with respect to Dr. Kwon and (ii) each option granted to Dr. Kwon vests as to 100% of the number of shares subject to such options upon an Acquisition Event if, in connection with or during the twelve month period following an Acquisition Event, Dr. Kwon incurs a Termination of services as the result of (a) an involuntary termination by the Company without Cause (as defined in the 2011 Plan) or (b) a voluntary termination of service by Dr. Kwon for Good Reason (as defined in the 2011 Plan), in each case provided that Dr. Kwon executes a general release of claims in favor of us.
Change in Control and Severance Provisions
Steven Basta.
Under Mr. Basta’s employment agreement, in the event Mr. Basta’s employment with us is terminated without “cause” (as defined below) or he resigns from his employment for “good reason” (as defined below), and Mr. Basta executes and does not revoke a general release of claims in favor of us, then Mr. Basta will receive the following: (i) an amount equal to his base salary that would have been earned during the twelve months following the date of termination (the “CEO severance period”), payable in one lump sum; (ii) continued health benefits pursuant to COBRA for the CEO severance period; and (iii) any stock options or restricted stock awards held by Mr. Basta will become vested and if applicable, exercisable with respect to that number of shares of our common stock that would have vested if Mr. Basta had remained employed during the CEO severance period. Such payments during the CEO severance period will commence on the 60
th
day following Mr. Basta’s termination date.
In addition, on the date of
completion
of a “Change in Control” transaction (as defined in the 2011 Plan), (i) the vesting with respect to 100% of the remaining unvested stock options and other equity awards held by Mr. Basta will accelerate;
(ii) Mr. Basta will be entitled to receive payment of any target bonus amount pro‑rated for the period from January 1 of the year of termination through the date of the Change in Control; and (iii) Mr. Basta will be entitled to payment of full potential target bonus amount during the CEO severance period.
For purposes of Mr. Basta’s employment agreement:
“cause” means if it has caused or is reasonably expected to result in material injury to the Company: (i) the executive’s gross negligence or willful failure substantially to perform his or her duties and responsibilities to the Company or deliberate violation of a Company policy, which failure is not corrected within 30 days after the board of directors has given the executive written notice specifying the failure in reasonable detail, and he or she had an opportunity to address the board of directors with, at the executive’s option, counsel present; (ii) the executive’s intentional commission of any act of fraud, embezzlement or dishonesty against the Company or any other willful misconduct; (iii) the executive’s improper, unauthorized use or disclosure of any proprietary information or trade secrets of the Company or any other party to whom the executive owes an obligation of nondisclosure as a result of his or her relationship with the Company; or (iv) the executive’s willful breach of any material obligations under any written agreement or covenant with the Company, which failure is not corrected within 30 days after the board of directors has given the executive written notice specifying the failure in reasonable detail, and the executive has had an opportunity to address the board of directors with, at the executive’s option, counsel present.
“good reason” means the occurrence at any time of any of the following without the executive’s prior written consent: (i) removal from the current executive officer position held by such executive with respect to the Company resulting in a material diminution of the executive’s authority, duties or responsibilities (other than a mere change in title following any merger or consolidation of the Company with another entity); (ii) the assignment of duties or responsibilities materially inconsistent with those customarily associated with the position of such executive officer or a material diminution of the executive’s position, authority, duties or responsibilities (other than a mere change in title following any merger or consolidation of the Company with another entity); (iii) a material reduction in the executive’s base salary; (iv) any willful failure or willful breach by the Company of any of the material obligations of the executive’s employment agreement; or (v) a requirement that the executive relocate his principal place of business by more than 50 miles; provided that the executive will not be deemed to have good reason unless (a) the executive first provides the Company with written notice of the condition giving rise to good reason within 90 days of its initial occurrence, and (b) the Company fails to cure such condition within 30 days after receiving such written notice.
Paul Kwon, M.D.
Under Dr. Kwon’s employment agreement, in the event Dr. Kwon’s employment with us is terminated without “cause” (as defined below) or he resigns from his employment for “good reason” (as defined below), and Dr. Kwon executes and does not revoke a general release of claims in favor of us, then Dr. Kwon will receive the following: an amount equal to his base salary that would have been earned during the six months following the date of termination (the “SVP severance period”), payable in one lump sum. Such payments will be made on the 60
th
day following Dr. Kwon’s termination date.
In addition, in the event termination without “cause” or for “good reason” of Dr. Kwon occurs in connection with or following a change of control, Dr. Kwon will be entitled to (i) an amount equal to his base salary that would have been earned during the SVP severance period; (ii) payment of any target bonus amount pro‑rated for the period from January 1 of the year of termination through the termination date; (iii) payment of full potential target bonus amount during the SVP severance period; and (iv) acceleration of vesting with respect to 100% of the remaining unvested stock options and other equity awards held by Dr. Kwon on the date of consummation of the change of control transaction.
For purposes of the employment agreement of Dr. Kwon:
“cause” means (i) the executive’s gross negligence or willful failure substantially to perform his duties and responsibilities to the Company or deliberate violation of a Company policy; (ii) the executive’s commission of any act of fraud, embezzlement or dishonesty against the Company or any other willful misconduct that has caused or is reasonably expected to result in material injury to the Company; (iii) the executive’s unauthorized use or disclosure of any proprietary information or trade secrets of the Company or any other party to whom he owes an obligation of nondisclosure as a result of his relationship with the Company; or (iv) the executive’s willful breach of any of his obligations under any written agreement or covenant with the Company.
“good reason” means the occurrence at any time of any of the following without the executive’s prior written consent: (i) a material diminution of the executive’s authority, duties or responsibilities (other than a mere change in title following any merger or consolidation of the Company with another entity); (ii) the assignment of duties or responsibilities materially inconsistent with those customarily associated with the position of such executive officer or a material diminution of the executive’s position, authority, duties or responsibilities (other than a mere change in title following any merger or consolidation of the Company with another entity); (iii) a material reduction in the executive’s base salary; (iv) any willful failure or willful breach by the Company of any of the material obligations of the executive’s employment agreement; (v) a requirement that the executive relocate his principal place of business by more than 50 miles; or (vi) a requirement that he travel more than 30% of the time; provided, that, the executive will not be deemed to have good reason unless (a) the executive first provides the Company with written notice of the condition giving rise to good reason within 90 days of its initial occurrence, and (b) the Company fails to cure such condition within 30 days after receiving such written notice.
Terms and Conditions of 401(k) Plan
We participate in a tax‑qualified retirement plan that provides eligible U.S. employees with an opportunity to save for retirement on a tax advantaged basis. Eligible employees are able to defer eligible compensation subject to applicable annual Internal Revenue Code (the “Code”) limits. Employees’ pre‑tax contributions are allocated
to each participant’s individual account and are then invested in selected investment alternatives according to the participants’ directions. Employees are immediately and fully vested in their contributions. The 401(k) plan is intended to be qualified under Section 401(a) of the Code with the 401(k) plan’s related trust intended to be tax exempt under Section 501(a) of the Code. As a tax‑qualified retirement plan, contributions to the 401(k) plan and earnings on those contributions are not taxable to the employees until distributed from the 401(k) plan.
Employee Benefits and Perquisites
All of our full‑time employees, including our NEOs, are eligible to participate in our health and welfare plans, including medical, dental and vision benefits, medical and dependent care flexible spending accounts, short‑term and long‑term disability insurance and life insurance. Unlike the cap that we have for the payment of monthly health care premiums for each of our non‑executive, full‑time employees, we pay the full monthly health premium costs for each of our executive officers, including our NEOs. Other than the payment of health care premiums in full, we do not provide our NEOs with perquisites or other personal benefits, other than the retirement, health and welfare benefits that apply uniformly to all of our employees.
Equity Compensation Plans
2018 Omnibus Incentive Plan
We intend to adopt a 2018 Omnibus Incentive Plan, or 2018 Plan, to be effective on the day prior to the first public trading date of our common stock. The 2018 Plan will provide for the grant of incentive stock options, non‑qualified stock options, stock appreciation rights, restricted stock, restricted stock units, dividend equivalent rights and other stock and cash‑based awards (including annual cash incentives and long‑term cash incentives). Shares issued under the 2018 Plan will be shares of our common stock. Incentive stock options may be granted only to our employees and employees of any parent or subsidiary corporation. All other awards may be granted to our employees, directors or consultants and to employees, directors or consultants of any affiliated entity.
Share Reserve.
We will reserve for issuance pursuant to awards under the 2018 Plan
shares of our common stock. In general, shares subject to awards granted under the 2018 Plan that are not issued or that are returned to us, for example, because the award is forfeited, the shares are retained by us in satisfaction of amounts owed with respect to an award or the shares are surrendered in payment of an exercise or purchase price or tax withholding, will again become available for awards under the 2018 Plan. Commencing with the first business day of each calendar year beginning with the calendar year following the calendar year in which occurs our initial public offering, such aggregate number of shares will be increased by a number equal to the least of (x)
shares, (y) four percent of the number of shares outstanding as of the last day of the immediately preceding calendar year, or (z) a lesser number of shares determined by the plan administrator.
Administration.
Our board of directors or a committee of our board of directors will administer the 2018 Plan. The administrator has the power to determine when awards will be granted, which employees, directors or consultants will receive awards, the terms of the awards, including the number of shares subject to each award and the vesting schedule of the awards, and to interpret the terms of the 2018 Plan and the award agreements. The administrator also has the authority to reduce the exercise prices of outstanding stock options and the base appreciation amount of any stock appreciation right if the exercise price or base appreciation amount exceeds the fair market value of the underlying shares, and to cancel such options and stock appreciation rights in exchange for new awards, in each case without stockholder approval.
Stock Options.
The 2018 Plan allows for the grant of incentive stock options that qualify under Section 422 of the Code, and non‑qualified stock options. The term of an option may not exceed 10 years, except that with respect to any employee who owns more than 10% of the voting power of all classes of our outstanding stock or any parent or subsidiary corporation as of the grant date, the term must not exceed five years, and the exercise price must equal at least 110% of the fair market value on the grant date. Not more than
shares of our common stock may be issued pursuant to incentive stock options granted under the 2018 Plan. After the continuous service of an option recipient terminates, the recipient’s options may be exercised, to the extent vested, for the period of time specified in the option agreement. However, an option may not be exercised later than the expiration of its term.
Stock Appreciation Rights.
The 2018 Plan allows for the grant of stock appreciation rights. Stock appreciation rights allow the recipient to receive the appreciation in the fair market value of our common stock between the date of grant and the exercise date. The administrator will determine the terms of stock appreciation rights, including when such rights become exercisable and whether to pay the increased appreciation in cash or with shares of our common stock, or a combination thereof. After the continuous service of a recipient of a stock appreciation right terminates, the recipient’s stock appreciation right may be exercised, to the extent vested, only to the extent provided in the stock appreciation right agreement.
Restricted Stock Awards.
The 2018 Plan allows for the grant of restricted stock. Restricted stock awards are shares of our common stock that vest in accordance with terms and conditions established by the administrator. The administrator will determine the number of shares of restricted stock granted to any employee, director or consultant. The administrator may impose whatever conditions on vesting that it determines to be appropriate. For example, the administrator may set restrictions based on the achievement of specific performance goals or on the continuation of service or employment. Shares of restricted stock that do not vest are subject to repurchase or forfeiture.
Restricted Stock Units.
The 2018 Plan allows for the grant of restricted stock units. Restricted stock units are awards that will result in payment to a recipient at the end of a specified period only if the vesting criteria established by the administrator are achieved or the award otherwise vests. The administrator may impose whatever conditions to vesting, or restrictions and conditions to payment, that it determines to be appropriate. The administrator may set restrictions based on the achievement of specific performance goals or on the continuation of service or employment. The administrator may specify in an award agreement that earned restricted stock units may be settled in shares of our common stock, other securities, cash or a combination thereof.
Other Awards.
The 2018 Plan also allows for the grant of cash or stock‑based awards that may or may not be subject to restrictions.
Terms of Awards.
The administrator of the 2018 Plan determines the provisions, terms and conditions of each award, including vesting schedules, forfeiture provisions, form of payment (cash, shares, or other consideration) upon settlement of the award, payment contingencies and satisfaction of any performance criteria.
Transferability of Awards.
The 2018 Plan allows for the transfer of awards under the 2018 Plan only (i) by will, (ii) by the laws of descent and distribution and (iii) for awards other than incentive stock options, to the extent and in the manner authorized by the administrator. Only the recipient of an incentive stock option may exercise such award during his or her lifetime.
Certain Adjustments.
In the event of certain changes in our capitalization, to prevent enlargement of the benefits or potential benefits available under the 2018 Plan, the administrator will make adjustments to one or more of the number of shares that are covered by outstanding awards, the exercise or purchase price of outstanding awards, the numerical share limits contained in the 2018 Plan and any other terms that the administrator determines require adjustment. In the event of our complete liquidation or dissolution, all outstanding awards will terminate immediately upon the completion of such transaction.
Changes in Control.
In the event of certain transactions specified in the
2018
Plan (each, a “change in control”), each award that is neither assumed nor replaced will vest and, if applicable, become exercisable. In the event of a change in control, the portion of each award that is assumed or replaced and that is scheduled to vest and, if applicable, become exercisable, on or after the twelve month anniversary of such change in control will instead vest and, if applicable, become exercisable on the date of such twelve month anniversary. In addition, in the event of a change in control, each award that is assumed or replaced will vest and, if applicable, become exercisable, and the post‑termination exercise period for such award (if applicable) will become twelve months, immediately upon termination of the holder’s service if such termination is by the successor company or the Company or an affiliate without “cause” (as defined in the
2018
Plan) or voluntarily by the holder with “good reason” (as defined in the
2018
Plan), in each case within twelve months after the change in control.
Plan Amendments and Termination.
The 2018 Plan will automatically terminate 10 years following the date it becomes effective, unless we terminate it sooner. In addition, our board of directors has the authority to amend,
suspend or terminate the 2018 Plan, subject to stockholder approval in the event such approval is required by law provided such action does not adversely affect the rights under any outstanding award.
We intend to file with the SEC a registration statement on Form S‑8 covering our shares of common stock issuable under the 2018 Plan.
2018 Employee Stock Purchase Plan
We intend to adopt a 2018 Employee Stock Purchase Plan, or ESPP, to be effective on the day prior to the first public trading date of our common stock. The ESPP will enable eligible employees of ours and designated affiliates to purchase shares of our common stock at a discount following its effectiveness. In this description, we sometimes refer to an eligible employee’s right to purchase shares of our common stock under the ESPP as an “option.” Purchases will be accomplished through participation in discrete offering periods. The ESPP is intended to qualify as an employee stock purchase plan under Section 423 of the Code.
We will initially reserve
shares of our common stock for issuance under the ESPP. In addition, the ESPP provides for an annual increase to the number of shares of our common stock available for issuance thereunder on the first business day of each calendar year beginning with the calendar year following the calendar year in which the ESPP becomes effective, equal to the lesser of (x)
shares, (y) one percent of the number of shares of our common stock outstanding as of the last day of the immediately preceding calendar year, and (z) a lesser number of shares determined by the administrator (as defined below).
Our board of directors or a committee designated by the board, which we refer to as the “administrator” in this description, will administer the ESPP. Our employees generally are eligible to participate in the ESPP (except for employees (i) whose customary employment is 20 hours or less per week, (ii) whose customary employment is for not more than 5 months in any calendar year, (iii) who have not been employed for such continuous period as the administrator may require (up to a maximum of 2 years), or (iv) who are citizens or residents of a non‑US jurisdiction under certain circumstances, although the administrator may permit such categories of employees to participate in the ESPP in its discretion). Employees who are 5% stockholders, or would become 5% stockholders as a result of their participation in the ESPP, are ineligible to participate in the ESPP. We may impose additional restrictions on eligibility.
Under the ESPP, eligible employees generally will be able to acquire shares of our common stock by accumulating funds through payroll deductions. Our eligible employees will be able to select a rate of payroll deduction between 1% and 15% of their eligible compensation, unless otherwise determined by the ESPP administrator prior to the applicable offering period.
When an offering period commences, our employees who meet the eligibility requirements and wish to participate in the ESPP will be required to enroll in a timely manner. Once an employee is enrolled, participation will be automatic in subsequent offering periods. An employee’s participation automatically ends upon termination of employment for any reason.
It is anticipated that the offering periods will be for six months, unless otherwise determined by the ESPP administrator prior to the applicable offering period. The duration of the first offering period may be shorter or longer. The commencement date of the first offering period has not been set.
No participant will have the right to purchase our shares in an amount, when aggregated with purchase rights under all our employee stock purchase plans that are also in effect in the same calendar year(s), that has a fair market value of more than $25,000, determined as of the first day of the applicable offering period, for each calendar year in which that right is outstanding. In addition, no participant will be permitted to purchase more than
shares during any one offering period or such lesser amount determined by the administrator. The purchase price for shares of our common stock purchased under the ESPP may be as low as 85% of the lower of the fair market value of our common stock on the first trading day of the applicable offering period or the last trading day of the applicable offering period.
In the event of certain changes in control (as defined in the ESPP), each option will be assumed by the successor corporation or a parent or subsidiary of the successor corporation, unless the administrator determines to shorten the offering period then in progress, in which case the options will either be exercised automatically
or we will pay the option holder an amount equal to the excess, if any, of (x) the fair market value of the shares subject to the options over (y) the purchase price due had the options been exercised automatically.
The ESPP will terminate on the 10
th
anniversary of its adoption by our board of directors, unless it is terminated earlier by the administrator. The administrator may at any time and for any reason terminate or amend the ESPP. Except in connection with certain changes in control or changes in capitalization, no such termination can adversely affect options previously granted, provided that the ESPP may be terminated by the administrator under certain circumstances if the administrator determines that the termination of the ESPP or one or more offering periods is in our best interests or in the best interests of our stockholders. Except as described in the previous sentence, or in connection with certain changes in control or changes in capitalization, no amendment may make any change in any option theretofore granted which adversely affects the rights of any participant without the consent of the affected participants.
To the extent necessary to comply with Section 423 of the Code (or any successor rule or provision or any other applicable law), we will obtain stockholder approval of any amendment in such a manner and to such a degree as required.
We intend to file with the SEC a registration statement on Form S‑8 covering our shares of common stock issuable under the ESPP.
2011 Stock Incentive Plan, as amended
We adopted the 2011 Stock Incentive Plan, or the 2011 Plan, on December 9, 2011. The 2011 Plan provides for the grant of incentive stock options, non‑qualified stock options, restricted stock and other stock‑based awards. Shares issued under the 2011 Plan will be shares of our common stock. Incentive stock options may be granted only to our employees and employees of any parent or subsidiary corporation. All other awards may be granted to our employees, directors or consultants and to employees, directors or consultants of any affiliated entity. Following the closing of our initial public offering, we will make no further awards under the 2011 Plan.
Share Reserve
.
We have reserved for issuance pursuant to awards under the 2011 Plan 7,608,905 shares of our common stock. As of September 30, 2017, 5,807,569 shares of our common stock were covered by outstanding awards. In general, if any award granted under the 2011 Plan expires, terminates, is canceled or is forfeited for any reason, the number of shares of our common stock underlying such award will again be available for the purposes of awards under the 2011 Plan. However, as noted above, following the closing of our initial public offering, we will make no further awards under the 2011 Plan.
Administration
.
Our board of directors or a committee of our board of directors administers the 2011 Plan. The committee has full authority to, among other things, grant awards to eligible employees, consultants and non‑employee directors; to determine the number of shares of our common stock to be covered by each award; to determine the terms and conditions of any award (including the exercise or purchase price (if any), any restriction or limitation, any vesting schedule or acceleration thereof, or any forfeiture restrictions or waiver thereof, regarding any award and the shares of our common stock relating thereto, based on such factors, if any, as the committee may determine, in its sole discretion); to determine whether, to what extent and under what circumstances grants of awards under the 2011 Plan are to operate on a tandem basis and/or in conjunction with or apart from other awards made by us outside of the 2011 Plan; to determine whether and under what circumstances a stock option may be settled in cash, our common stock and/or restricted stock; to determine whether a stock option is intended to be an incentive stock option or non‑qualified stock option; to determine whether to require an eligible employee, non‑employee director or consultant, as a condition of the granting of any award, not to sell or otherwise dispose of shares of our common stock acquired pursuant to an award for a period of time as determined by the committee, in its sole discretion, following the date of the award; to modify, extend or renew an award, subject to certain restrictions; and generally, to exercise such powers and to perform such acts as the committee deems necessary or expedient to promote our best interests that are not in conflict with the provisions of the 2011 Plan. In addition, among other things, the committee has, in its sole discretion, the authority to adopt, alter and repeal such administrative rules, guidelines and practices governing the 2011 Plan and perform all acts, including the delegation of its administrative responsibilities (to the extent permitted by applicable law and applicable stock exchange rules), as it may, from time to time, deem advisable; to construe and interpret the terms and provisions of the 2011 Plan and any award granted under the 2011 Plan (and any agreements relating thereto) and to otherwise supervise the administration of the 2011 Plan. Any
decision, interpretation or other action made or taken in good faith by or at the direction of the Company, our board of directors or the committee (or any of its members) arising out of or in connection with the 2011 Plan is within the absolute discretion of all and each of them, as the case may be, and is final, binding and conclusive on us and all employees and participants and their respective heirs, executors, committees, successors and assigns.
Stock
Options.
The 2011 Plan allows for the grant of incentive stock options that may qualify for special tax treatment under Section 422 of the Code and non‑qualified stock options. The term of an option may not exceed 10 years, except that with respect to any employee who owns more than 10% of the voting power of all classes of our outstanding stock or any parent or subsidiary corporation as of the grant date, the term of an incentive stock option must not exceed five years, and the exercise price must equal at least 110% of the fair market value on the grant date. After the continuous service of an option recipient terminates, the recipient’s options may generally be exercised, to the extent vested, for the period of time specified in the option agreement. However, an option may not be exercised later than the expiration of its term.
Restricted Stock Awards.
Restricted stock may be issued either alone or in addition to other awards granted under the 2011 Plan. The committee may, in its sole discretion, determine the eligible employees, consultants and non‑employee directors to whom, and the time or times within which, grants of restricted stock will be made, the number of shares to be awarded, the purchase price (if any) to be paid by the participant, the time or times at which such awards may be subject to forfeiture (if any), the vesting schedule (if any) and rights to acceleration thereof, and all other terms and conditions of the awards. The committee may condition the grant or vesting of restricted stock upon the attainment of specified performance targets or such other factors as the committee may determine, in its sole discretion.
Other
Stock-Based Awards.
Other stock‑based awards may be granted either alone or in addition to or other awards granted under the 2011 Plan to all eligible participants. Subject to the provisions of the 2011 Plan, the committee has authority to determine the eligible employees, consultants and non‑employee directors to whom, and the time or times at which, other stock‑based awards will be made, the number of shares of our common stock to be awarded pursuant to such awards, and all other conditions of the awards. The committee may also provide for the grant of our common stock upon the completion of a specified performance period.
Stockholders Agreement and Other Requirements
.
As a condition to the receipt of shares of our common stock pursuant to an award granted under the 2011 Plan, the participant may be required to execute and deliver a stockholder’s agreement or such other documentation which sets forth certain restrictions on transferability of the shares of our common stock acquired upon exercise or purchase, a right of first refusal in favor of us and such other terms or restrictions as the board of directors or committee from time to time establishes. As a condition to the grant of an award, if requested by us and the lead underwriter of any public offering of our common stock, a participant may be subject to customary “lock‑up” restrictions. The participant may further be required to sign such documents as may be requested to effect the foregoing.
Non-Transferability
.
Generally, no stock will be transferable otherwise than by will or by the laws of descent and distribution. All stock options will be exercisable, during the participant’s lifetime, only by the participant. Shares of restricted stock or other stock‑based awards may not be transferred prior to the date on which shares are issued, or if later, the date on which any applicable restriction, performance or deferral period lapses.
Termination of Service
.
The 2011 Plan contains certain provisions related to treatment of awards upon termination of service by reason of death or disability; involuntary termination without cause; voluntary termination; and termination for cause (including, depending on the type of termination of service, post‑termination call rights in favor of us).
Acquisition Events
.
Generally, each award that, at the time of an acquisition event (as defined in the 2011 Plan), is scheduled to vest and, if applicable, become exercisable, on or after the 12 month anniversary of such acquisition event (ignoring, for this purpose, an
y accelerated vesting provisions) will instead vest and, if applicable, become exercisable on the date of such 12 month anniversary, subject to the absence of a termination (as defined in the 2011 Plan) with respect to the holder of such award as of the date of such 12 month anniversary.
Generally, if in connection with or during the 12 month period following an acquisition event, the participant holding such award incurs a termination of service as a result of (a) an involuntary termination by us without cause (as defined in the 2011 Plan), or (b) a voluntary termination of service by the participant for good reason (as defined in the 2011 Plan), then each award will vest and, if applicable, become exercisable, with respect to one 100% of the unvested shares of our common stock covered thereby, and the post‑termination exercise period for such award will be 12 months from the date of termination (or, if earlier, the expiration of the stated term thereof) provided the participant executes a general release of claims in favor of us.
In addition, generally, in the event of a change in control (as defined in the 2011 Plan), the committee may, but will not be obligated to: accelerate, vest or cause the restrictions to lapse with respect to all or any portion of an award; or cancel awards for fair value (as determined in good faith by the committee); or provide for the issuance of substitute awards that will substantially preserve the otherwise applicable terms of any affected awards previously granted under the 2011 Plan as determined by the committee in its sole discretion.
Amendment and Termination.
The board of directors or the committee may amend any or all of the provisions of the 2011 Plan, or suspend or terminate it entirely, retroactively or otherwise; provided, however, that if the committee, in its sole discretion, determines that the rights of a participant with respect to awards granted prior to such amendment, suspension or termination, may be adversely impaired, the consent of such participant will be required.
Company Call Rights, Rights of First Refusal and Other Right
s.
The committee may provide in the applicable award agreement alternative (or no) call rights and/or rights of first refusal and/or other rights at the time of grant (or, thereafter, if no rights of the participant are reduced) as it may decide in its sole discretion.
We intend to file with the SEC a registration statement on Form S‑8 covering our shares of common stock issuable under the 2011 Plan.
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
The following is a description of transactions since January 1, 2014 to which we have been a party, in which the amount involved exceeds $120,000, and in which any of our directors, executive officers or beneficial owners of more than 5% of our capital stock, or an affiliate or immediate family member thereof, had or will have a direct or indirect material interest.
Sales and Purchases of Securities
Series C Preferred Stock Financing
In July 2017, we issued an aggregate of 11,854,463 shares of our Series C convertible preferred stock at a price per share of $4.26 for aggregate proceeds to us of $50.5 million. The table below sets forth the number of shares of Series C convertible preferred stock sold to our directors, executive officers or beneficial owners of more than 5% of a class of our capital stock, or an affiliate or immediate family member thereof:
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Name
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Number of Shares
of Series C
Preferred Stock
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Purchase Price ($)
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Presidio Partners 2007, L.P.
(1)
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352,113
|
|
|
1,500,002
|
|
Remeditex Ventures, LLC
(2)
|
|
821,596
|
|
|
3,499,999
|
|
Vivo Capital Fund VIII, L.P.
(3)
|
|
2,816,902
|
|
|
12,000,003
|
|
F-Prime Capital Partners Healthcare Fund IV LP
(4)
|
|
821,596
|
|
|
3,499,999
|
|
venBio Global Strategic Fund II, L.P.
(5)
|
|
3,227,700
|
|
|
13,750,002
|
|
|
|
|
|
|
|
|
(1)
|
Consists of (i) 8,803 shares of Series C convertible preferred stock purchased by Presidio Partners 2007 (Parallel), L.P. (“Presidio Parallel”) and (ii) 343,310 shares of Series C convertible preferred stock purchased by held by Presidio Partners 2007, L.P. (“Presidio Partners”). David Collier, M.D., who was a member of our board of directors at the time of the Series C convertible preferred stock financing, is an affiliate of Presidio Parallel and Presidio Partners.
|
|
|
(2)
|
John Creecy, who was a member of our board of directors at the time of the Series C convertible preferred stock financing, is an affiliate of Remeditex Ventures, LLC.
|
|
|
(3)
|
Consists of (i) 2,475,118 shares of Series C convertible preferred stock purchased by Vivo Capital Fund VIII, L.P. (“Vivo Capital”) and (ii) 341,784 shares of Series C convertible preferred stock purchased by Vivo Capital Surplus Fund VIII, L.P. (“Vivo Surplus”). Albert Cha, M.D., Ph.D., who is a member of our board of directors, is an affiliate of Vivo Capital and Vivo Surplus.
|
|
|
(4)
|
Ketan Patel, M.D., who was a member of our board of directors at the time of the Series C preferred stock financing, is an affiliate of F‑Prime Capital Partners Healthcare Fund IV LP.
|
|
|
(5)
|
Aaron Royston, M.D., who is a member of our board of directors, is an affiliate of venBio Global Strategic Fund II, L.P.
|
Series B Preferred Stock Financing
In November 2015, we issued an aggregate of 14,106,583 shares of our Series B convertible preferred stock at a price per share of $3.19 for aggregate proceeds to us of $45.0 million. The table below sets forth the number of shares of Series B convertible preferred stock sold to our directors, executive officers or beneficial owners of more than 5% of a class of our capital stock, or an affiliate or immediate family member thereof:
|
|
|
|
|
|
|
|
|
|
|
|
|
Name
|
|
Number of Shares
of Series B
Preferred Stock
|
|
Purchase Price ($)
|
Vivo Capital Fund VIII, L.P.
(1)
|
|
7,210,032
|
|
|
23,000,002
|
|
Presidio Partners 2007, L.P.
(2)
|
|
2,351,097
|
|
|
7,499,999
|
|
Remeditex Ventures, LLC
(3)
|
|
2,351,097
|
|
|
7,499,999
|
|
F-Prime Capital Partners Healthcare Fund IV LP
(4)
|
|
2,194,357
|
|
|
6,999,999
|
|
|
|
|
|
|
|
|
(1)
|
Consists of (i) 6,335,215 shares of Series B convertible preferred stock purchased by Vivo Capital and (ii) 874,817 shares of Series B preferred stock purchased by Vivo Surplus. Albert Cha, M.D., PH.D., who is a member of our board of directors, is an affiliate of Vivo Capital Fund VIII, L.P.
|
|
|
(2)
|
Consists of (i) 58,777 shares of Series B convertible preferred stock purchased by Presidio Parallel and (ii) 2,292,320 shares of Series B preferred stock purchased by held by Presidio Partners. David Collier, M.D., who was a member of our board of directors at the time of the Series B preferred stock financing, is an affiliate of Presidio Parallel and Presidio Partners.
|
|
|
(3)
|
John Creecy, who was a member of our board of directors at the time of the Series B convertible preferred stock financing, is an affiliate of Remeditex Ventures, LLC.
|
|
|
(4)
|
Ketan Patel, who was a member of our board of directors at the time of the Series B convertible preferred stock financing, is an affiliate of F‑Prime Capital Partners Healthcare Fund IV LP.
|
Series A Preferred Stock Financing
During the period from December 2011 through May 2015, we issued an aggregate of 14,300 shares of our Series A convertible preferred stock, together with an aggregate of 8,000,000 shares of our common stock, for aggregate proceeds to us of $14.3 million. The table below sets forth the number of shares of Series A convertible preferred stock and common stock sold to our directors, executive officers or beneficial owners of more than 5% of a class of our capital stock, or an affiliate or immediate family member thereof:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Name
|
|
Number of Shares of Common Stock
|
|
Number of Shares
of Series A
Preferred Stock
|
|
Purchase Price ($)
|
Velocity Pharmaceutical Holdings, LLC
(1)
|
|
4,000,000
|
|
|
7,150
|
|
|
7,150,000
|
|
Remeditex Ventures, LLC
(2)
|
|
4,000,000
|
|
|
7,150
|
|
|
7,150,000
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Includes 84,000 shares of common stock issued to members of the board of directors of Velocity Pharmaceutical Holdings, LLC. David Collier, M.D., who was a member of our board of directors at the time of the Series A convertible preferred stock financing, is an affiliate of Velocity Pharmaceutical Holdings, LLC.
|
|
|
(2)
|
John Creecy, who was a member of our board of directors at the time of the Series A convertible preferred stock financing, is an affiliate of Remeditex Ventures, LLC.
|
Certain Relationships with Velocity Pharmaceutical Development, LLC
David Collier, M.D. a former member of our board of directors, is the Chief Executive Officer of Velocity Pharmaceutical Development, or VPD. Xiaoming Zhang, Ph.D., our Senior Vice President, Non-Clinical and Pharmaceutical Development was previously a Venture Partner of VPD, for which he continues to provide consulting services. We were originally founded and managed by VPD. In that context, from 2011 through
2015, VPD provided management services and until September 2015 managed substantially all of our activities under a development services agreement. In early 2016, we entered into a new development services agreement with VPD under which VPD provided ongoing support to us during 2016. VPD’s services to us under both arrangements terminated at the end of 2016. Development services fees paid to VPD were $0.8 million and $1.0 million for the years ended
December 31, 2015
and
2016
, respectively. Development services fees paid to VPD were $0.8 million and
$0
for the
nine
months ended
September 30, 2016
and 2017, respectively. We also reimbursed VPD for consulting, travel and other expenses incurred on our behalf.
Relationship with Board Member
David Collier, M.D., a former member of our board of directors, entered into a consulting agreement with us, pursuant to which Dr. Collier provides certain advisory and support services in exchange for options to purchase 84,942 shares of our common stock, with an exercise price of $0.68 per share, subject to certain vesting requirements.
Director and Executive Officer Compensation
Please see “Director Compensation” and “Executive Compensation” for information regarding the compensation of our directors and executive officers.
Employment Agreements
We have entered into employment agreements with our executive officers. For more information regarding these agreements, see “Executive Compensation—Narrative to Summary Compensation Table and Outstanding Equity Awards at Fiscal Year End.”
Indemnification Agreements and Directors’ and Officers’ Liability Insurance
We have entered into or intend to enter into indemnification agreements with each of our directors and executive officers. These agreements will require us to, among other things, indemnify each director and executive officer to the fullest extent permitted by Delaware law, including indemnification of expenses such as attorneys’ fees, judgments, penalties fines and settlement amounts incurred by the director or executive officer in any action or proceeding, including any action or proceeding by or in right of us, arising out of the person’s services as a director or executive officer. We have obtained an insurance policy that insures our directors and officers against certain liabilities, including liabilities arising under applicable securities laws. For additional information see “Management—Limitation of Liability and Indemnification Matters.”
Investors’ Rights Agreements
We entered into a second amended and restated investors’ rights agreement with the purchasers of our outstanding preferred stock, including entities with which certain of our directors are affiliated. As of September 30, 2017, the holders of approximately 33.9 million shares of our common stock, including the shares of common stock issuable upon the conversion of our Series A, Series B and Series C convertible preferred stock, are entitled to rights with respect to the registration of their shares under the Securities Act. For a more detailed description of these registration rights, see “Description of Capital Stock—Registration Rights.” The investor rights agreement also provides for a right of first offer in favor of certain holders of preferred stock with regard to certain issuances of our securities. The right of first offer will not apply to, and will terminate upon the completion of, this offering.
Voting Agreement
We entered into a third amended and restated voting agreement with certain holders of our common stock and preferred stock. Upon the completion of this offering, the third amended and restated voting agreement will terminate. For a description of the amended and restated voting agreement, see “Management—Board Composition—Voting Arrangements.”
Right of First Refusal and Co-Sale Agreement
We entered into an amended and restated right of first refusal and co‑sale agreement with certain holders of our common stock and preferred stock. This agreement provides for rights of first refusal and co‑sale relating to the shares of our common stock held by the parties to the agreement. Upon the completion of this offering, the amended and restated right of first refusal and co‑sale agreement will terminate.
Policies and Procedures for Related Party Transactions
Prior to the completion of this offering, our board of directors will adopt a written related person transaction policy, to be effective upon the closing of this offering, setting forth the policies and procedures for the review and approval or ratification of related person transactions. This policy will cover, with certain exceptions set forth in Item 404 of Regulation S‑K under the Securities Act, any transaction, arrangement or relationship, or any series of similar transactions, arrangements or relationships in which we were or are to be a participant, where the amount involved exceeds $120,000 and a related person had or will have a direct or indirect material interest, including without limitation purchases of goods or services by or from the related person or entities in which the related person has a material interest, indebtedness, guarantees of indebtedness and employment by us of a related person. In reviewing and approving any such transactions, our audit committee will be tasked to consider all relevant facts and circumstances, including but not limited to whether the transaction is on terms comparable to those that could be obtained in an arm’s length transaction with an unrelated third party and the extent of the related person’s interest in the transaction. All of the transactions described in this section occurred prior to the adoption of this policy.
PRINCIPAL STOCKHOLDERS
The following table sets forth information relating to the beneficial ownership of our common stock as of December 15, 2017, by:
|
|
▪
|
each person, or group of affiliated persons, known by us to beneficially own more than 5% of our outstanding shares of common stock;
|
|
|
▪
|
each of our named executive officers; and
|
|
|
▪
|
all of our current directors and executive officers as a group.
|
The number of shares beneficially owned by each entity, person, director or executive officer is determined in accordance with the rules of the SEC, and the information is not necessarily indicative of beneficial ownership for any other purpose. Under such rules, beneficial ownership includes any shares over which the individual has sole or shared voting power or investment power as well as any shares that the individual has the right to acquire within 60 days after December 15, 2017 through the exercise of any stock option, warrants or other rights. Except as otherwise indicated, and subject to applicable community property laws, the persons named in the table have sole voting and investment power with respect to all shares of common stock held by that person.
The percentage of shares beneficially owned before the offering is computed on the basis of 40,268,326 shares of our common stock outstanding as of December 15, 2017, which reflects the assumed conversion of all of our outstanding shares of Series A convertible preferred stock, Series B convertible preferred stock and Series C convertible preferred stock into an aggregate of 25,975,346 shares of common stock. In addition, the percentage of shares beneficially owned after the offering gives effect to the issuance of shares in the offering. Shares of our common stock that a person has the right to acquire within 60 days after December 15, 2017 are deemed outstanding for purposes of computing the percentage ownership of the person holding such rights, but are not deemed outstanding for purposes of computing the percentage ownership of any other person, except with respect to the percentage ownership of all directors and executive officers as a group. Unless otherwise indicated below, the address for each beneficial owner listed is c/o Menlo Therapeutics Inc., 200 Cardinal Way, 2nd Floor, Redwood City, California 94063.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Beneficial Ownership Prior to this Offering
|
|
Percentage of Shares Beneficially Owned
|
Name of Beneficial Owner
|
|
Number of
Outstanding
Shares
Beneficially
Owned
|
|
Number of Shares Exercisable Within 60 Days
|
|
Number of Shares Beneficially Owned
|
|
Before Offering
|
|
After Offering
|
5% and Greater Stockholders:
|
|
|
|
|
|
|
|
|
|
|
Funds Affiliated with Vivo Capital
(1)
|
|
10,026,934
|
|
|
—
|
|
|
10,026,934
|
|
|
24.9
|
%
|
|
|
Remeditex Ventures, LLC
(2)
|
|
7,179,843
|
|
|
—
|
|
|
7,179,843
|
|
|
17.8
|
%
|
|
|
Funds Affiliated with Presidio Partners
(3)
|
|
6,626,360
|
|
|
—
|
|
|
6,626,360
|
|
|
16.5
|
%
|
|
|
Merck Sharp & Dohme Corp.
(4)
|
|
3,353,450
|
|
|
—
|
|
|
3,353,450
|
|
|
8.3
|
%
|
|
|
venBio Global Strategic Fund II, L.P.
(5)
|
|
3,227,700
|
|
|
—
|
|
|
3,227,700
|
|
|
8.0
|
%
|
|
|
F-Prime Capital Partners Healthcare Fund IV LP
(6)
|
|
3,015,953
|
|
|
—
|
|
|
3,015,953
|
|
|
7.5
|
%
|
|
|
Named Executive Officers and Directors:
|
|
|
|
|
|
|
|
|
|
|
Steven Basta
(7)
|
|
906,200
|
|
|
593,962
|
|
|
1,500,162
|
|
|
3.7
|
%
|
|
|
Paul Kwon
(8)
|
|
—
|
|
|
235,271
|
|
|
235,271
|
|
|
*
|
|
|
|
David McGirr
(9)
|
|
—
|
|
|
4,864
|
|
|
4,864
|
|
|
*
|
|
|
|
Paul Berns
(10)
|
|
—
|
|
|
4,864
|
|
|
4,864
|
|
|
*
|
|
|
|
Albert Cha, M.D., Ph.D.
(1)
|
|
10,026,934
|
|
|
—
|
|
|
10,026,934
|
|
|
24.9
|
%
|
|
|
Aaron Royston, M.D.
(5)
|
|
3,227,700
|
|
|
—
|
|
|
3,227,700
|
|
|
8.0
|
%
|
|
|
Ted Ebel
(11)
|
|
33,330
|
|
|
26,551
|
|
|
59,881
|
|
|
*
|
|
|
|
Scott Whitcup, M.D.
(12)
|
|
—
|
|
|
182,320
|
|
|
182,320
|
|
|
*
|
|
|
|
All current directors and executive officers as a group (9 persons)
(13)
|
|
14,194,164
|
|
|
1,042,968
|
|
|
15,241,996
|
|
|
36.9
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
Indicates beneficial ownership of less than 1% of the total outstanding common stock.
|
|
|
(1)
|
Consists of (i) 6,335,215 shares of common stock issuable upon conversion of Series B convertible preferred stock and 2,475,118 shares of common stock issuable upon conversion of Series C convertible preferred stock held by Vivo Capital Fund VIII, L.P. (“Vivo Capital”) and (ii) 874,817 shares of common stock issuable upon conversion of Series B convertible preferred stock and 341,784 shares of common stock issuable upon conversion of Series C convertible preferred stock held by Vivo Capital Surplus Fund VIII, L.P. (“Vivo Surplus”). Vivo Capital VIII, LLC (“Vivo LLC”) is the general partner of Vivo Capital and Vivo Surplus, has voting and investment control over the above described shares. The managing members of Vivo LLC are Drs. Cha, Edgar Engleman, Chen Yu, Frank Kung and Mr. Shan Fu, each of whom may be deemed to have shared voting and dispositive power over the shares held by Vivo Capital and Vivo Surplus. The address of Vivo Capital and Vivo Surplus is 505 Hamilton Ave, Suite 207, Palo Alto, CA 94301.
|
|
|
(2)
|
Consists of 4,000,000 shares of common stock, 7,150 shares of common stock issuable upon conversion of Series A convertible preferred Stock, 2,351,097 shares of common stock issuable upon conversion of Series B convertible preferred stock and 821,596 shares of common stock issuable upon conversion of Series C convertible preferred stock held by Remeditex Ventures, LLC (“Remeditex”). The address of Remeditex is 2727 North Harwood, Suite 200, Dallas, Texas 75201. Mr. Creecy is the chief executive officer of Remeditex, and as such may be deemed to have shared voting and dispositive control over the shares held by Remeditex.
|
|
|
(3)
|
Consists of (i) 97,900 shares of common stock, 179 shares of common stock issuable upon conversion of Series A convertible preferred stock, 58,777 shares of common stock issuable upon conversion of Series B convertible preferred stock and 8,803 shares of common stock issuable upon conversion of Series C convertible preferred stock held by Presidio Partners 2007 (Parallel), L.P. (“Presidio Parallel”) and (ii) 3,818,100 shares of common stock, 6,971 shares of common stock issuable upon conversion of Series A convertible preferred stock, 2,292,320 shares of common stock issuable upon conversion of Series B Preferred Stock and 343,310 shares of common stock issuable upon conversion of Series C convertible preferred stock held by Presidio Partners 2007, L.P. (“Presidio Partners”). Presidio Partners 2007
|
GP, L.P. (“Presidio GP”) is the sole general partner of Presidio Parallel and Presidio Partners. Dr. Collier, James Watson and Faysal Sohail are the general partners of Presidio GP and may be deemed to have shared voting and dispositive control over the shares held by Presidio Parallel and Presidio Partners. The address of Presidio Parallel and Presidio Partners is 1 Letterman Drive, Building C, Suite CM500, San Francisco, CA 94129.
|
|
(4)
|
Consists of 3,353,450 shares of common stock held by Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., a publicly traded company. The address of Merck Sharp and Dohme Corp. is 126 E. Lincoln Avenue, RY70‑200, Rahway, NJ 07065‑0900.
|
|
|
(5)
|
Consists of 3,227,700 shares of common stock issuable upon conversion of Series C convertible preferred stock held by venBio Global Strategic Fund II, L.P. (“venBio”). The address of venBio is 1700 Owens Street, Suite 595, San Francisco, California 94158. venBio Global Strategic GP II, L.P. (“venBio GP”) is the general partner of venBio. venBio Global Strategic GP II, Ltd. (“venBio Ltd.”) is the general partner of venBio GP. Dr. Royston is a managing partner of venBio Partners and may be deemed to have shared voting and dispositive control over the shares held by venBio.
|
|
|
(6)
|
Consists of 2,194,357 shares of common stock issuable upon conversion of Series B Preferred Stock and 821,596 shares of common stock issuable upon conversion of Series C convertible preferred stock held by F‑Prime Capital Partners Healthcare Fund IV LP (“F‑Prime”). The address of F‑Prime is One Main Street, 13th Floor, Cambridge, Massachusetts 02142.
|
|
|
(7)
|
Consists of (i) 50,000 shares of common stock, (ii) 680,000 shares of common stock held by The Shelter Trust under the Basta Revocable Trust (the “Shelter Trust”), (iii) 176,200 shares of common stock held by the Basta Revocable Trust dated August 4, 2017 (the “Basta Trust”), and (iv) 593,962 shares of common stock issuable upon the exercise of stock options within 60 days of December 15, 2017. As a trustee of each of the Shelter Trust and the Basta Trust, Mr. Basta has shared voting and investment power over the shares of common stock held by each of the Shelter Trust and the Basta Trust.
|
|
|
(8)
|
Consists of 235,271 shares of common stock issuable upon the exercise of stock options within 60 days of December 15, 2017.
|
|
|
(9)
|
Consists of 4,864 shares of common stock issuable upon the exercise of stock options within 60 days of December 15, 2017.
|
|
|
(10)
|
Consists of 4,864 shares of common stock issuable upon the exercise of stock options within 60 days of December 15, 2017.
|
|
|
(11)
|
Consists of (i) 33,330 shares of common stock, and (ii) 26,551 shares of common stock issuable upon the exercise of stock options within 60 days of December 15, 2017.
|
|
|
(12)
|
Consists of 182,320 shares of common stock issuable upon the exercise of stock options within 60 days of December 15, 2017.
|
|
|
(13)
|
Consists of (i) 939,530 shares of common stock, (ii) 13,254,634 shares of common stock issuable upon conversion of preferred stock and (iii) 1,042,968 shares of common stock that may be acquired pursuant to the exercise of stock options within 60 days of December 15, 2017.
|
DESCRIPTION OF CAPITAL STOCK
The following summary describes our capital stock and the material provisions of our amended and restated certificate of incorporation and our amended and restated bylaws, which will become effective immediately prior to the completion of this offering, the investor rights agreement to which we and certain of our stockholders are parties and of the Delaware General Corporation Law. Because the following is only a summary, it does not contain all of the information that may be important to you. For a complete description, you should refer to our amended and restated certificate of incorporation, amended and restated bylaws and second amended and restated investor rights agreement, copies of which have been filed as exhibits to the registration statement of which this prospectus is part.
General
Immediately prior to the completion of this offering, we will file our amended and restated certificate of incorporation that authorizes 300,000,000 shares of common stock, $0.0001 par value per share, and 20,000,000 shares of preferred stock, $0.0001 par value per share, in each case after giving effect to a 1-for- reverse stock split of our capital stock we plan to effect in connection with this offering. As of September 30, 2017, there were outstanding:
|
|
▪
|
40,268,326 shares of our common stock, on an as‑converted basis, held by approximately 15 stockholders of record; and
|
|
|
▪
|
5,807,569 shares of our common stock issuable upon exercise of outstanding stock options.
|
Common Stock
Voting Rights
Each holder of our common stock is entitled to one vote for each share on all matters submitted to a vote of the stockholders, including the election of directors. Our stockholders do not have cumulative voting rights in the election of directors. Accordingly, holders of a majority of the voting shares are able to elect all of the directors. In addition, the affirmative vote of holders of 66‑2/3% of the voting power of all of the then outstanding voting stock will be required to take certain actions, including amending certain provisions of our amended and restated certificate of incorporation, such as the provisions relating to amending our amended and restated bylaws, procedures for our stockholder meetings, the classified board, director liability, and exclusive forum for proceedings.
Dividends
Subject to preferences that may be applicable to any then outstanding preferred stock, holders of our common stock are entitled to receive dividends, if any, as may be declared from time to time by our board of directors out of legally available funds.
Liquidation
In the event of our liquidation, dissolution or winding up, holders of our common stock will be entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all of our debts and other liabilities and the satisfaction of any liquidation preference granted to the holders of any then outstanding shares of preferred stock.
Rights and Preferences
Holders of our common stock have no preemptive, conversion, subscription or other rights, and there are no redemption or sinking fund provisions applicable to our common stock. The rights, preferences and privileges of the holders of our common stock are subject to and may be adversely affected by the rights of the holders of shares of any series of our preferred stock that we may designate in the future.
Fully Paid and Nonassessable
All of our outstanding shares of common stock are, and the shares of common stock to be issued in this offering will be, fully paid and nonassessable.
Preferred Stock
Immediately prior to the completion of this offering, all outstanding shares of our preferred stock will be converted into shares of our common stock. See Note 6 to our audited financial statements included elsewhere in this prospectus for a description of our currently outstanding preferred stock. Immediately prior to the completion of this offering, our amended and restated certificate of incorporation will be amended and restated to delete all references to such shares of preferred stock. From and after the closing of this offering, our board of directors will have the authority, without further action by our stockholders, to issue up to 20,000,000 shares of preferred stock in one or more series and to fix the rights, preferences, privileges and restrictions thereof. These rights, preferences and privileges could include dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting, or the designation of, such series, any or all of which may be greater than the rights of common stock. The issuance of our preferred stock could adversely affect the voting power of holders of common stock and the likelihood that such holders will receive dividend payments and payments upon our liquidation. In addition, the issuance of preferred stock could have the effect of delaying, deferring or preventing a change in control of our company or other corporate action. Immediately after completion of this offering, no shares of preferred stock will be outstanding, and we have no present plan to issue any shares of preferred stock.
Registration Rights
Under our second amended and restated investors’ rights agreement, based on the number of shares outstanding as of September 30, 2017, following the completion of this offering, the holders of approximately 33.9 million shares of common stock, or their transferees, have the right to require us to register their shares under the Securities Act so that those shares may be publicly resold, and also have the right to include their shares in any registration statement we file, in each case as described below.
Demand Registration Rights
Based on the number of shares outstanding as of September 30, 2017, after the completion of this offering, the holders of approximately 33.9 million shares of our common stock (on an as‑converted basis), or their transferees, will be entitled to certain demand registration rights (subject to certain exceptions). Beginning 180 days following the effectiveness of the registration statement of which this prospectus is a part, the holders of at least 50% of these shares can request that we register all or a portion of their shares if the aggregate price to the public of the shares offered is at least $10.0 million. Additionally, we will not be required to effect a demand registration during the period beginning the date of filing and ending 180 days following the effectiveness of a company‑initiated registration statement relating to an initial public offering of our securities.
Piggyback Registration Rights
Based on the number of shares outstanding as of September 30, 2017, after the completion of this offering, in the event that we determine to register any of our securities under the Securities Act (subject to certain exceptions), either for our own account or for the account of other security holders, the holders of approximately 33.9 million shares of our common stock (on an as‑converted basis), or their transferees, will be entitled to certain “piggyback” registration rights allowing the holders to include their shares in such registration, subject to certain marketing and other limitations. As a result, whenever we propose to file a registration statement under the Securities Act, other than with respect to a registration related to employee benefit plans, the offer and sale of debt securities, or corporate reorganizations or certain other transactions, the holders of these shares are entitled to notice of the registration and have the right, subject to limitations that the underwriters may impose on the number of shares included in the registration, to include their shares in the registration. In an underwritten offering, the managing underwriter, if any, has the right, subject to specified conditions, to limit the number of shares such holders may include.
Form S-3 Registration Rights
Based on the number of shares outstanding as of September 30, 2017, after the completion of this offering, the holders of approximately 31.5 million shares of our common stock (on an as‑converted basis), or their transferees, will be entitled to certain Form S‑3 registration rights. The holders of these shares can make a written request that we register their shares on Form S‑3 if we are eligible to file a registration statement on Form S‑3 and if the aggregate price to the public of the shares offered is at least $1.0 million net of certain expenses related to the sale of the shares. These stockholders may make an unlimited number of requests for
registration on Form S‑3, but in no event shall we be required to file a registration if we have, within the twelve‑month period preceding the date of such request, already effected two registrations on Form S‑3.
Expenses of Registration
We will pay the registration expenses of the holders of the shares registered pursuant to the demand, piggyback and Form S‑3 registration rights described above, including the expenses of one counsel for the selling holders, not to exceed $35,000 (subject to certain exceptions).
Expiration of Registration Rights
The demand, piggyback and Form S‑3 registration rights described above will expire, with respect to any particular stockholder, upon the earlier of five years after the completion of this offering, when that stockholder can sell all of its shares under Rule 144 of the Securities Act during any three‑month period or our liquidation, dissolution or winding up.
Anti-Takeover Effects of Provisions of our Amended and Restated Certificate of Incorporation, our Amended and Restated Bylaws and Delaware Law
Some provisions of Delaware law and our amended and restated certificate of incorporation and our amended and restated bylaws that will become effective immediately prior to the completion of this offering contain provisions that could make the following transactions more difficult: acquisition of us by means of a tender offer; acquisition of us by means of a proxy contest or otherwise; or removal of our incumbent officers and directors. It is possible that these provisions could make it more difficult to accomplish or could deter transactions that stockholders may otherwise consider to be in their best interest or in our best interests, including transactions that might result in a premium over the market price for our shares.
These provisions, summarized below, are expected to discourage coercive takeover practices and inadequate takeover bids. These provisions are also designed to encourage persons seeking to acquire control of us to first negotiate with our board of directors. We believe that the benefits of increased protection of our potential ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure us outweigh the disadvantages of discouraging these proposals because negotiation of these proposals could result in an improvement of their terms.
Delaware Anti-Takeover Statute
We are subject to Section 203 of the Delaware General Corporation Law, which prohibits persons deemed “interested stockholders” from engaging in a “business combination” with a publicly‑held Delaware corporation for three years following the date these persons become interested stockholders unless the business combination is, or the transaction in which the person became an interested stockholder was, approved in a prescribed manner or another prescribed exception applies. Generally, an “interested stockholder” is a person who, together with affiliates and associates, owns, or within three years prior to the determination of interested stockholder status did own, 15% or more of a corporation’s voting stock. Generally, a “business combination” includes a merger, asset or stock sale, or other transaction resulting in a financial benefit to the interested stockholder. The existence of this provision may have an anti‑takeover effect with respect to transactions not approved in advance by the board of directors, such as discouraging takeover attempts that might result in a premium over the market price of our common stock.
Undesignated Preferred Stock
The ability to authorize undesignated preferred stock makes it possible for our board of directors to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt to change control of us. These and other provisions may have the effect of deterring hostile takeovers or delaying changes in control or management of our company.
Special Stockholder Meetings
Our amended and restated bylaws provide that a special meeting of stockholders may be called by our board of directors, our President, our Chief Executive Officer, or the Secretary.
Requirements for Advance Notification of Stockholder Nominations and Proposals
Our amended and restated bylaws establish advance notice procedures with respect to stockholder proposals and the nomination of candidates for election as directors, other than nominations made by or at the direction of the board of directors or a committee of the board of directors.
Elimination of Stockholder Action by Written Consent
Our amended and restated certificate of incorporation and our amended and restated bylaws eliminate the right of stockholders to act by written consent without a meeting.
Classified Board; Election and Removal of Directors; Filling Vacancies
Our board of directors is divided into three classes. The directors in each class will serve for a three‑year term, one class being elected each year by our stockholders, with staggered three‑year terms. Only one class of directors will be elected at each annual meeting of our stockholders, with the other classes continuing for the remainder of their respective three‑year terms. Because our stockholders do not have cumulative voting rights, our stockholders holding a majority of the shares of common stock outstanding will be able to elect all of our directors. Our amended and restated certificate of incorporation provides for the removal of any of our directors only for cause and requires a stockholder vote by the holders of at least a 66‑2/3% of the voting power of the then outstanding voting stock. For more information on the classified board, see “Management—Board Composition.” Furthermore, any vacancy on our board of directors, however occurring, including a vacancy resulting from an increase in the size of the board, may only be filled by a resolution of the board of directors unless the board of directors determines that such vacancies shall be filled by the stockholders. This system of electing and removing directors and filling vacancies may tend to discourage a third party from making a tender offer or otherwise attempting to obtain control of us, because it generally makes it more difficult for stockholders to replace a majority of the directors.
Choice of Forum
Our amended and restated certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the exclusive forum for: any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claim against us arising pursuant to the Delaware General Corporation Law, our amended and restated certificate of incorporation or our amended and restated bylaws; or any action asserting a claim against us that is governed by the internal affairs doctrine. Although our amended and restated certificate of incorporation contains the choice of forum provision described above, it is possible that a court could find that such a provision is inapplicable for a particular claim or action or that such provision is unenforceable.
Amendment of Charter Provisions
The amendment of any of the above provisions, except for the provision making it possible for our board of directors to issue undesignated preferred stock, would require approval by a stockholder vote by the holders of at least a 66‑2/3% of the voting power of the then outstanding voting stock.
The provisions of the Delaware General Corporation Law, our amended and restated certificate of incorporation and our amended and restated bylaws could have the effect of discouraging others from attempting hostile takeovers and, as a consequence, they may also inhibit temporary fluctuations in the market price of our common stock that often result from actual or rumored hostile takeover attempts. These provisions may also have the effect of preventing changes in our management. It is possible that these provisions could make it more difficult to accomplish transactions that stockholders may otherwise deem to be in their best interests.
Limitations of Liability and Indemnification Matters
For a discussion of liability and indemnification, see “Management—Limitation on Liability and Indemnification Matters.”
Listing
We have applied to list our common stock on the Nasdaq Global Market under the symbol “MNLO.”
Transfer Agent and Registrar
The transfer agent and registrar for our common stock will be American Stock Transfer Trust Company, LLC. The transfer agent and registrar’s address is 6201 15th Avenue, Brooklyn, New York 11219.
SHARES ELIGIBLE FOR FUTURE SALE
Prior to this offering, there has been no public market for our common stock. Future sales of our common stock, including shares issued upon the exercise of outstanding 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 completion 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
Based on the number of shares of our common stock outstanding as of September 30, 2017 and assuming an initial public offering price of $ per share (the midpoint of the range set forth on the cover of this prospectus), upon the completion of this offering and assuming (1) the automatic conversion of all shares of our outstanding Series A, Series B and Series C convertible preferred stock at September 30, 2017, (2) no exercise of the underwriters’ option to purchase additional shares of common stock, and (3) no exercise of any of our other outstanding options, we will have outstanding an aggregate of approximately shares of common stock. Of these shares, all of the shares of common stock to be sold in this offering and any shares sold upon exercise of the underwriters’ option to purchase additional shares, will be freely tradable in the public market without restriction or further registration under the Securities Act, unless the shares are held by any of our “affiliates” as such term is defined in Rule 144 of the Securities Act. All remaining shares of common stock held by existing stockholders immediately prior to the completion 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.
As a result of the lock‑up agreements referred to below and the provisions of Rule 144 and Rule 701 under the Securities Act, based on the number of shares of our common stock outstanding as of September 30, 2017 and assumptions (1)‑(3) described above, the shares of our common stock (excluding the shares sold in this offering) that will be available for sale in the public market are as follows:
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Approximate Number of Shares
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First Date Available for Sale into Public Market
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million shares
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180 days after the date of this prospectus upon expiration of the lock‑up agreements referred to below, subject in some cases to applicable volume limitations under Rule 144
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Lock-Up Agreements
In connection with this offering, we, our directors, our executive officers and substantially all of our other stockholders and option holders have agreed, subject to certain exceptions, with the underwriters not to dispose of or hedge any shares of our common stock or securities convertible into or exchangeable for shares of common stock during the period from the date of the lock‑up agreement continuing through the date 180 days after the date of this prospectus, except with the prior written consent of Jefferies LLC and Piper Jaffray & Co.
Prior to the completion of the offering, certain of our employees, including our executive officers, and/or directors may enter into written trading plans that are intended to comply with Rule 10b5‑1 under the Exchange Act. Sales under these trading plans would not be permitted until the expiration of the lock‑up agreements relating to the offering described above.
Following the lock‑up periods set forth in the agreements described above, all of the shares of our common stock that are restricted securities or are held by our affiliates as of the date of this prospectus will be eligible for sale in the public market in compliance with Rule 144 under the Securities Act.
Rule 144
In general, under Rule 144, as currently in effect, once we have been subject to the public company reporting requirements of the Securities Exchange Act of 1934, as amended, or 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 six 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 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 six 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 common stock that does not exceed the greater of:
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1% of the number of common shares then outstanding, which will equal approximately shares of common stock immediately after this offering (calculated as of September 30, 2017 on the basis of the assumptions (1)‑(3) described above); or
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the average weekly trading volume of our common stock on the Nasdaq Global Market during the four calendar weeks preceding the filing of a notice on Form 144 with respect to such sale.
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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 144’s minimum holding period requirements (subject to the terms of the lock‑up agreement referred to above, if applicable).
Registration Rights
Based on the number of shares outstanding as of September 30, 2017, after the completion of this offering, the holders of approximately 31.5 million shares of our common stock, or their transferees, will, subject to the lock‑up agreements referred to above, be entitled to certain rights with respect to the registration of the offer and sale of those shares under the Securities Act. For a description of these registration rights, see “Description of Capital Stock—Registration Rights.” If the offer and sale of these shares are registered, they will be freely tradable without restriction under the Securities Act.
Stock Plans
We intend to file with the SEC a registration statement under the Securities Act covering the shares of common stock that we may issue upon exercise of outstanding options reserved for issuance under our 2011 Stock Incentive Plan, 2018 Omnibus Incentive Plan and 2018 Employee Stock Purchase Plan. Such registration statement is expected to be filed and become effective as soon as practicable after the completion of this offering. Accordingly, shares registered under such registration statement will be available for sale in the open market following its effective date, subject to Rule 144 volume limitations and the lock‑up agreements described above, if applicable.
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS
The following is a summary of the material U.S. federal income tax consequences applicable to non‑U.S. holders (as defined below) with respect to the purchase, ownership and disposition of shares of our common stock, but does not purport to be a complete analysis of all potential tax considerations related thereto. This summary is based on current provisions of the Internal Revenue Code of 1986, as amended, or the Code, final, temporary or proposed regulations promulgated under the Code by the U.S. Treasury Department, or the Treasury, administrative rulings and judicial opinions, all of which are subject to change, possibly with retroactive effect. We have not sought any ruling from the U.S. Internal Revenue Service, or the IRS, with respect to the statements made and the conclusions reached in the following summary, and there can be no assurance that the IRS will agree with such statements and conclusions.
This summary is limited to non‑U.S. holders who purchase shares of our common stock issued pursuant to this offering and who hold such shares of our common stock as capital assets (within the meaning of Section 1221 of the Code).
This discussion does not address all aspects of U.S. federal income taxation that may be important to a particular non‑U.S. holder in light of that non‑U.S. holder’s individual circumstances, nor does it address the potential application of the Medicare contribution tax, any aspects of U.S. federal estate or gift tax laws, or tax considerations arising under the laws of any non‑U.S., state or local jurisdiction. This discussion also does not address tax considerations applicable to a non‑U.S. holder subject to special treatment under the U.S. federal income tax laws, including without limitation:
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banks, insurance companies or other financial institutions;
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partnerships or other pass‑through entities;
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tax‑exempt organizations;
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tax‑qualified retirement plans;
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dealers in securities or currencies;
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traders in securities that elect to use a mark‑to‑market method of accounting for their securities;
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U.S. expatriates and certain former citizens or long‑term residents of the United States;
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controlled foreign corporations;
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passive foreign investment companies;
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persons that own, or have owned, actually or constructively, more than 5% of our common stock; and
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persons that will hold common stock as a position in a hedging transaction, “straddle” or “conversion transaction” for tax purposes.
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If a partnership (or entity classified as a partnership for U.S. federal income tax purposes) is a beneficial owner of shares of our common stock, the tax treatment of a partner in the partnership (or member in such other entity) will generally depend upon the status of the partner and the activities of the partnership. Any partner in a partnership holding shares of our common stock (and such partnership) should consult their own tax advisors.
PROSPECTIVE INVESTORS ARE URGED TO 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 SHARES OF OUR COMMON STOCK ARISING UNDER THE U.S. FEDERAL ESTATE OR GIFT TAX RULES OR UNDER THE LAWS OF ANY STATE, LOCAL, NON-U.S. OR OTHER TAXING JURISDICTION OR UNDER ANY APPLICABLE TAX TREATY.
Definition of Non-U.S. Holder
For purposes of this summary, a “non‑U.S. holder” is any beneficial owner of shares of our common stock (other than a partnership or other entity treated as a partnership for U.S. federal income tax purposes) that is not a U.S. person. A “U.S. person” is any of the following:
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an individual citizen or resident of the United States;
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a corporation created or organized in or under the laws of the United States, any state thereof or the District of Columbia (or entity treated as such for U.S. federal income tax purposes);
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an estate, the income of which is includible in gross income for U.S. federal income tax purposes regardless of its source; or
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a trust if: (i) a court within the United States is able to exercise primary supervision over the administration of the trust and one or more U.S. persons have the authority to control all substantial decisions of the trust; or (ii) it has a valid election in effect under applicable Treasury regulations to be treated as a U.S. person.
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Distributions on Our Common Stock
As described in the section titled “Dividend Policy,” we currently do not anticipate paying any cash dividends in the foreseeable future. If, however, we make cash or other property distributions on our common stock (other than certain pro rata distributions of shares of our common stock), such distributions will constitute dividends for U.S. federal income tax purposes to the extent paid from our current earnings and profits for that taxable year 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 holder’s adjusted tax basis in the shares of our common stock, but not below zero. Any excess will be treated as gain realized on the sale or other disposition of shares of our common stock and will be treated as described under the section titled “—Gain on Sale or Other Disposition of Shares of Our Common Stock” below.
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. To receive the benefit of a reduced treaty rate, a non‑U.S. holder must furnish to us or our paying agent a valid IRS Form W‑8BEN or W‑8BEN‑E (or applicable successor form) certifying, under penalties of perjury, such holder’s qualification for the reduced rate. This certification must be provided to us or our paying agent prior to the payment of dividends and must be updated periodically.
If a non‑U.S. holder holds shares of our common stock in connection with the conduct of a trade or business in the United States, and dividends paid on shares of our common stock are effectively connected with such holder’s U.S. trade or business (and, if required by an applicable income tax treaty, are attributable to a permanent establishment maintained by the non‑U.S. holder in the United States), the non‑U.S. holder will be exempt from the aforementioned U.S. federal withholding tax. To claim the exemption, the non‑U.S. holder must furnish to us or our paying agent a properly executed IRS Form W‑8ECI (or applicable successor form).
Such effectively connected dividends generally will be subject to U.S. federal income tax on a net income basis at the regular graduated U.S. federal income tax rates in the same manner as if such holder were a resident of the United States. A non‑U.S. holder that is a non‑U.S. corporation also may be subject to an additional branch profits tax equal to 30% (or such lower rate specified by an applicable income tax treaty) of a portion of its effectively connected earnings and profits for the taxable year. Non‑U.S. holders should consult any applicable income tax treaties that may provide for different rules.
A non‑U.S. holder that claims exemption from withholding or the benefit of an applicable income tax treaty generally will be required to satisfy applicable certification and other requirements prior to the distribution date. Non‑U.S. holders that do not timely provide us or our paying agent with the required certification, 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 a relevant income tax treaty or applicability of other exemptions from withholding.
Gain on Sale or Other Disposition of Shares of Our Common Stock
Subject to the discussion below regarding backup withholding, a non‑U.S. holder generally will not be subject to U.S. federal income tax on any gain realized upon the sale or other disposition of shares of our common stock unless:
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the gain is effectively connected with a trade or business carried on by the non‑U.S. holder in the United States and, if required by an applicable income tax treaty, the gain is attributable to a permanent establishment of the non‑U.S. holder maintained in the United States;
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the non‑U.S. holder is an individual present in the United States for 183 days or more in the taxable year of disposition and certain other requirements are met; or
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we are or have been a U.S. real property holding corporation, or a USRPHC, for U.S. federal income tax purposes at any time within the shorter of the five‑year period preceding the disposition and the non‑U.S. holder’s holding period for the shares of our common stock, and our common stock has ceased to be traded on an established securities market prior to the beginning of the calendar year in which the sale or other disposition occurs. The determination of whether we are a USRPHC depends on the fair market value of our U.S. real property interests relative to the fair market value of our other trade or business assets and our foreign real property interests.
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We believe we currently are not, and we do not anticipate becoming, a USRPHC for U.S. federal income tax purposes.
Gain described in the first bullet point above will be subject to U.S. federal income tax on a net income basis at regular graduated U.S. federal income tax rates generally in the same manner as if such holder were a resident of the United States. A non‑U.S. holder that is a non‑U.S. corporation also may be subject to an additional branch profits tax equal to 30% (or such lower rate specified by an applicable income tax treaty) of a portion of its effectively connected earnings and profits for the taxable year. Non‑U.S. holders should consult any applicable income tax treaties that may provide for different rules.
Gain described in the second bullet point above will be subject to U.S. federal income tax at a flat 30% rate (or such lower rate specified by an applicable income tax treaty) but may be offset by U.S. source capital losses (even though the individual is not considered a resident of the United States), provided that the non‑U.S. holder has timely filed U.S. federal income tax returns with respect to such losses. Non‑U.S. holders should consult any applicable income tax treaties that may provide for different rules.
Non‑U.S. holders should consult their tax advisors regarding potentially applicable tax treaties that may provide for different rules.
Backup Withholding and Information Reporting
Generally, we must report annually to the IRS and to each non‑U.S. holder the amount of dividends paid to, and the tax withheld with respect to, each non‑U.S. holder. This information also may be made available under a specific treaty or agreement with the tax authorities in the country in which the non‑U.S. holder resides or is established. Backup withholding, currently at a 28% rate, generally will not apply to distributions to a non‑U.S. holder of shares of our common stock provided the non‑U.S. holder furnishes to us or our paying agent the required certification as to its non‑U.S. status, such as by providing a valid IRS Form W‑8BEN, IRS Form W‑8BEN‑E, or IRS Form W‑8ECI, or certain other requirements are met. Notwithstanding the foregoing, backup withholding may apply if either we or our paying agent has actual knowledge, or reason to know, that the holder is a U.S. person that is not an exempt recipient.
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. holder’s U.S. federal income tax liability, provided the required information is timely furnished to the IRS.
Foreign Account Tax Compliance Act
The Foreign Account Tax Compliance Act, commonly referred to as “FATCA” (sections 1471 through 1474 of the Code), imposes a 30% U.S. withholding tax on certain U.S. source payments, including interest (and original
issue discount), dividends, other fixed or determinable annual or periodical gain, profits, and income, and on the gross proceeds from a disposition of property of a type which can produce U.S. source dividends if paid to a foreign financial institution (including amounts paid to a foreign financial institution on behalf of a non‑U.S. holder), unless such institution enters into an agreement with the Treasury to collect and provide to the Treasury certain information regarding U.S. financial account holders, including certain account holders that are foreign entities with U.S. owners, with such institution or otherwise complies with FATCA. FATCA also generally imposes a withholding tax of 30% on dividends paid to a non‑financial foreign entity unless such entity provides the withholding agent with a certification that it does not have any substantial U.S. owners or a certification identifying the direct and indirect substantial U.S. owners of the entity. Under certain circumstances, a holder may be eligible for refunds or credits of such taxes.
The Treasury and the IRS have announced that withholding on payments of gross proceeds from a sale or redemption of common stock will only apply to payments made after December 31, 2018. If FATCA withholding is imposed, a beneficial owner that is not a foreign financial institution generally will be entitled to a refund of any amounts withheld by filing a U.S. federal income tax return (which may entail significant administrative burden). Prospective investors should consult their tax advisors regarding FATCA.
UNDERWRITING
Subject to the terms and conditions set forth in the underwriting agreement, dated , among us and Jefferies LLC, Piper Jaffray & Co. and Guggenheim Securities LLC, as the representatives of the underwriters named below and the joint book‑running managers of this offering, we have agreed to sell to the underwriters, and each of the underwriters has agreed, severally and not jointly, to purchase from us the respective number of shares of common stock shown opposite its name below:
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Underwriter
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Number of Shares
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Jefferies LLC
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Piper Jaffray & Co.
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Guggenheim Securities LLC
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JMP Securities LLC
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Total
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The underwriting agreement provides that the obligations of the several underwriters are subject to certain conditions precedent such as the receipt by the underwriters of officers’ certificates and legal opinions and approval of certain legal matters by their counsel. The underwriting agreement provides that the underwriters will purchase all of the shares of common stock if any of them are purchased. If an underwriter defaults, the underwriting agreement provides that the purchase commitments of the nondefaulting underwriters may be increased or the underwriting agreement may be terminated. We have agreed to indemnify the underwriters and certain of their controlling persons against certain liabilities, including liabilities under the Securities Act, and to contribute to payments that the underwriters may be required to make in respect of those liabilities.
The underwriters have advised us that, following the completion of this offering, they currently intend to make a market in the common stock as permitted by applicable laws and regulations. However, the underwriters are not obligated to do so, and the underwriters may discontinue any market‑making activities at any time without notice in their sole discretion. Accordingly, no assurance can be given as to the liquidity of the trading market for the common stock, that you will be able to sell any of the common stock held by you at a particular time or that the prices that you receive when you sell will be favorable.
The underwriters are offering the shares of common stock subject to their acceptance of the shares of common stock from us and subject to prior sale. The underwriters reserve the right to withdraw, cancel or modify offers to the public and to reject orders in whole or in part.
Commission and Expenses
The underwriters have advised us that they propose to offer the shares of common stock to the public at the initial public offering price set forth on the cover page of this prospectus and to certain dealers, which may include the underwriters, at that price less a concession not in excess of $ per share of common stock. The underwriters may allow, and certain dealers may reallow, a discount from the concession not in excess of $ per share of common stock to certain brokers and dealers. After the offering, the initial public offering price, concession and reallowance to dealers may be reduced by the representatives. No such reduction will change the amount of proceeds to be received by us as set forth on the cover page of this prospectus.
The following table shows the public offering price, the underwriting discounts and commissions that we are to pay the underwriters and the proceeds, before expenses, to us in connection with this offering. Such amounts are shown assuming both no exercise and full exercise of the underwriters’ option to purchase additional shares.
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Per Share
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Total
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Without
Option to Purchase Additional Shares
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With
Option to Purchase Additional Shares
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Without
Option to Purchase Additional Shares
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With
Option to Purchase Additional Shares
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Public offering price
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$
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$
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$
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$
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Underwriting discounts and commissions paid by us
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$
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$
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$
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$
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Proceeds to us, before expenses
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$
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$
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$
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$
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We estimate expenses payable by us in connection with this offering, other than the underwriting discounts and commissions referred to above, will be approximately $ . We have also agreed to reimburse the underwriters for certain expenses, including an amount not to exceed $ in connection with the clearance of this offering with the Financial Industry Regulatory Authority, or FINRA, as set forth in the underwriting agreement. In accordance with FINRA Rule 5110, the reimbursement of these fees is deemed underwriting compensation for this offering.
Determination of Offering Price
Prior to this offering, there has not been a public market for our common stock. Consequently, the initial public offering price for our common stock will be determined by negotiations between us and the representatives. Among the factors to be considered in these negotiations will be prevailing market conditions, our financial information, market valuations of other companies that we and the underwriters believe to be comparable to us, estimates of our business potential, the present state of our development and other factors deemed relevant.
We offer no assurances that the initial public offering price will correspond to the price at which the common stock will trade in the public market subsequent to the offering or that an active trading market for the common stock will develop and continue after the offering.
Listing
We have applied to have our common stock approved for listing on the Nasdaq Global Market under the trading symbol “MNLO”.
Stamp Taxes
If you purchase shares of common stock offered in this prospectus, you may be required to pay stamp taxes and other charges under the laws and practices of the country of purchase, in addition to the offering price listed on the cover page of this prospectus.
Option to Purchase Additional Shares
We have granted to the underwriters an option, exercisable for 30 days from the date of this prospectus, to purchase, from time to time, in whole or in part, up to an aggregate of shares from us at the public offering price set forth on the cover page of this prospectus, less underwriting discounts and commissions. If the underwriters exercise this option, each underwriter will be obligated, subject to specified conditions, to purchase a number of additional shares proportionate to that underwriter’s initial purchase commitment as indicated in the table above. This option may be exercised only if the underwriters sell more shares than the total number set forth on the cover page of this prospectus.
No Sales of Similar Securities
We, our officers, directors and certain holders of our outstanding capital stock have agreed, subject to specified exceptions, not to directly or indirectly:
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sell, offer, contract or grant any option to sell (including any short sale), pledge, transfer, establish an open “put equivalent position” within the meaning of Rule 16a‑l(h) under the Securities Exchange Act of 1934, as amended, or
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otherwise dispose of any shares of common stock, options or warrants to acquire shares of common stock, or securities exchangeable or exercisable for or convertible into shares of common stock currently or hereafter owned either of record or beneficially, or
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publicly announce an intention to do any of the foregoing for a period of 180 days after the date of this prospectus without the prior written consent of Jefferies LLC and Piper Jaffray & Co.
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This restriction terminates after the close of trading of the common stock on and including the 180
th
day after the date of this prospectus.
Jefferies LLC and Piper Jaffray & Co. may, in their sole discretion and at any time or from time to time before the termination of the 180‑day period release all or any portion of the securities subject to lock‑up agreements. There are no existing agreements between the underwriters and any of our stockholders who will execute a lock‑up agreement, providing consent to the sale of shares prior to the expiration of the lock‑up period.
Stabilization
The underwriters have advised us that, pursuant to Regulation M under the Securities Exchange Act of 1934, as amended, certain persons participating in the offering may engage in short sale transactions, stabilizing transactions, syndicate covering transactions or the imposition of penalty bids in connection with this offering. These activities may have the effect of stabilizing or maintaining the market price of the common stock at a level above that which might otherwise prevail in the open market. Establishing short sales positions may involve either “covered” short sales or “naked” short sales.
“Covered” short sales are sales made in an amount not greater than the underwriters’ option to purchase additional shares of our common stock in this offering. The underwriters may close out any covered short position by either exercising their option to purchase additional shares of our common stock or purchasing shares of our common stock in the open market. In determining the source of shares to close out 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 shares through the option to purchase additional shares.
“Naked” short sales are sales in excess of the option to purchase additional shares of our common stock. The underwriters must close out any 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 shares of our common stock in the open market after pricing that could adversely affect investors who purchase in this offering.
A stabilizing bid is a bid for the purchase of shares of common stock on behalf of the underwriters for the purpose of fixing or maintaining the price of the common stock. A syndicate covering transaction is the bid for or the purchase of shares of common stock on behalf of the underwriters to reduce a short position incurred by the underwriters in connection with the offering. Similar to other purchase transactions, the underwriter’s purchases to cover the syndicate short sales may have the effect of raising or maintaining the market price of our common stock or preventing or retarding a decline in the market price of our common stock. As a result, the price of our common stock may be higher than the price that might otherwise exist in the open market. A penalty bid is an arrangement permitting the underwriters to reclaim the selling concession otherwise accruing to a syndicate member in connection with the offering if the common stock originally sold by such syndicate member are purchased in a syndicate covering transaction and therefore have not been effectively placed by such syndicate member.
Neither we nor any of the underwriters make any representation or prediction as to the direction or magnitude of any effect that the transactions described above may have on the price of our common stock. The underwriters are not obligated to engage in these activities and, if commenced, any of the activities may be discontinued at any time.
The underwriters may also engage in passive market making transactions in our common stock on the Nasdaq Global Market in accordance with Rule 103 of Regulation M during a period before the commencement of offers or sales of shares of our common stock in this offering and extending through the completion of distribution. A passive market maker must display its bid at a price not in excess of the highest independent bid of that security. However, if all independent bids are lowered below the passive market maker’s bid that bid must then be lowered when specified purchase limits are exceeded.
Electronic Distribution
A prospectus in electronic format may be made available by e‑mail or on the web sites or through online services maintained by one or more of the underwriters or their affiliates. In those cases, prospective investors may view offering terms online and may be allowed to place orders online. The underwriters may agree with us to allocate a specific number of shares of common stock for sale to online brokerage account holders. Any such allocation for online distributions will be made by the underwriters on the same basis as other allocations. Other than the prospectus in electronic format, the information on the underwriters’ web sites and any information contained in any other web site maintained by any of the underwriters is not part of this prospectus, has not been approved and/or endorsed by us or the underwriters and should not be relied upon by investors.
Other Activities and Relationships
The underwriters and certain of their affiliates are full service financial institutions engaged in various activities, which may include securities trading, commercial and investment banking, financial advisory, investment management, investment research, principal investment, hedging, financing and brokerage activities. The underwriters and certain of their affiliates have, from time to time, performed, and may in the future perform, various commercial and investment banking and financial advisory services for us and our affiliates, for which they received or will receive customary fees and expenses.
In the ordinary course of their various business activities, the underwriters and certain of their affiliates may make or hold a broad array of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (including bank loans) for their own account and for the accounts of their customers, and such investment and securities activities may involve securities and/or instruments issued by us and our affiliates. If the underwriters or their respective affiliates have a lending relationship with us, they routinely hedge their credit exposure to us consistent with their customary risk management policies. The underwriters and their respective affiliates may hedge such exposure by entering into transactions which consist of either the purchase of credit default swaps or the creation of short positions in our securities or the securities of our affiliates, including potentially the common stock offered hereby. Any such short positions could adversely affect future trading prices of the common stock offered hereby. The underwriters and certain of 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 securities or instruments and may at any time hold, or recommend to clients that they acquire, long and/or short positions in such securities and instruments.
NOTICE TO HOLDERS
Australia
This prospectus is not a disclosure document for the purposes of Australia’s Corporations Act 2001 (Cth) of Australia, or Corporations Act, has not been lodged with the Australian Securities & Investments Commission and is only directed to the categories of exempt persons set out below. Accordingly, if you receive this prospectus in Australia:
You confirm and warrant that you are either:
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a “sophisticated investor” under section 708(8)(a) or (b) of the Corporations Act;
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a “sophisticated investor” under section 708(8)(c) or (d) of the Corporations Act and that you have provided an accountant’s certificate to the company which complies with the requirements of section 708(8)(c)(i) or (ii) of the Corporations Act and related regulations before the offer has been made; or
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a “professional investor” within the meaning of section 708(11)(a) or (b) of the Corporations Act.
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To the extent that you are unable to confirm or warrant that you are an exempt sophisticated investor or professional investor under the Corporations Act any offer made to you under this prospectus is void and incapable of acceptance.
You warrant and agree that you will not offer any of the shares issued to you pursuant to this prospectus for resale in Australia within 12 months of those securities being issued unless any such resale offer is exempt from the requirement to issue a disclosure document under section 708 of the Corporations Act.
Canada
Resale Restrictions
The distribution of our shares of common stock in Canada is being made only in the provinces of Ontario, Quebec, Manitoba, Alberta and British Columbia on a private placement basis exempt from the requirement that we prepare and file a prospectus with the securities regulatory authorities in each province where trades of these securities are made. Any resale of the shares of common stock in Canada must be made under applicable securities laws which may vary depending on the relevant jurisdiction, and which may require resales to be made under available statutory exemptions or under a discretionary exemption granted by the applicable Canadian securities regulatory authority. Purchasers are advised to seek legal advice prior to any resale of the securities.
Representations of Canadian Purchasers
By purchasing our shares of common stock in Canada and accepting delivery of a purchase confirmation, a purchaser is representing to us and the dealer from whom the purchase confirmation is received that:
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the purchaser is entitled under applicable provincial securities laws to purchase the shares without the benefit of a prospectus qualified under those securities laws as it is an “accredited investor” as defined under National Instrument 45-106-
Prospectus Exemptions
or subsection 73.3(1) of the
Securities Act
(Ontario), as applicable,
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the purchaser is a “permitted client” as defined in National Instrument 31-103-
Registration Requirements,
Exemptions
and Ongoing Registrant Obligations
,
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where required by law, the purchaser is purchasing as principal and not as agent, and
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the purchaser has reviewed the text above under Resale Restrictions.
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Conflicts of Interest
Canadian purchasers are hereby notified that the underwriters are relying on the exemption set out in section 3A.3 or 3A.4, if applicable, of National Instrument 33-105-
Underwriting Conflicts
from having to provide certain conflict of interest disclosure in this document.
Statutory Rights of Action
Securities legislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if the prospectus (including any amendment thereto) such as this document 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 purchaser’s province or territory. The purchaser of these securities in Canada should refer to any applicable provisions of the securities legislation of the purchaser’s province or territory for particulars of these rights or consult with a legal advisor.
Enforcement of Legal Rights
All of our directors and officers as well as the experts named herein may be located outside of Canada and, as a result, it may not be possible for Canadian purchasers to effect service of process within Canada upon us or those persons. All or a substantial portion of our assets and the assets of those persons may be located outside of Canada and, as a result, it may not be possible to satisfy a judgment against us or those persons in Canada or to enforce a judgment obtained in Canadian courts against us or those persons outside of Canada.
Taxation and Eligibility for Investment
Canadian purchasers of our shares of common stock should consult their own legal and tax advisors with respect to the tax consequences of an investment in the shares in their particular circumstances and about the eligibility of the shares for investment by the purchaser under relevant Canadian legislation.
European Economic Area
In relation to each member state of the European Economic Area which has implemented the Prospectus Directive, each referred to herein as a Relevant Member State, with effect from and including the date on which the Prospectus Directive is implemented in that Relevant Member State, referred to herein as the Relevant Implementation Date, no offer of any securities which are the subject of the offering contemplated by this prospectus has been or will be made to the public in that Relevant Member State other than any offer where a prospectus has been or will be published in relation to such securities that has been approved by the competent authority in that Relevant Member State or, where appropriate, approved in another Relevant Member State and notified to the relevant competent authority in that Relevant Member State in accordance with the Prospectus Directive, except that with effect from and including the Relevant Implementation Date, an offer of such securities may be made to the public in that Relevant Member State:
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to any legal entity which is a “qualified investor” as defined in the Prospectus Directive;
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to fewer than 100 or, if the Relevant Member State has implemented the relevant provision of the 2010 PD Amending Directive, 150, natural or legal persons (other than qualified investors as defined in the Prospectus Directive), as permitted under the Prospectus Directive, subject to obtaining the prior consent of the representatives of the underwriters for any such offer; or
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in any other circumstances falling within Article 3(2) of the Prospectus Directive,
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provided that no such offer of securities shall require the Company or any of the underwriters to publish a prospectus pursuant to Article 3 of the Prospectus Directive or supplement a prospectus pursuant to Article 16 of the Prospectus Directive.
For the purposes of this provision, the expression an “offer to the public” in relation to any securities 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 the securities to be offered so as to enable an investor to decide to purchase or subscribe the securities, as the same may be varied in that Relevant Member State by any measure implementing the Prospectus Directive in that Relevant Member State and the expression “Prospectus Directive” means Directive 2003/71/EC (and amendments thereto, including the 2010 PD Amending Directive, to the extent implemented in the Relevant Member State), and includes any relevant implementing measure in the Relevant Member State and the expression “2010 PD Amending Directive” means Directive 2010/73/EU.
Hong Kong
No securities have been offered or sold, and no securities may be offered or sold, in Hong Kong, by means of any document, other than to persons whose ordinary business is to buy or sell shares or debentures, whether as principal or agent; or to “professional investors” as defined in the Securities and Futures Ordinance (Cap. 571) of Hong Kong and any rules made under that Ordinance; or in other circumstances which do not result in the document being a “prospectus” as defined in the Companies Ordinance (Cap. 32) of Hong Kong or which do not constitute an offer to the public within the meaning of the Companies Ordinance (Cap.32) of Hong Kong. No document, invitation or advertisement relating to the securities has been issued or 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), which is directed at, or the contents of which are likely to be accessed or read by, the public of Hong Kong (except if permitted under the securities laws of Hong Kong) other than with respect to securities which are or are intended to be disposed of only to persons outside Hong Kong or only to “professional investors” as defined in the Securities and Futures Ordinance (Cap. 571) of Hong Kong and any rules made under that Ordinance.
This prospectus has not been registered with the Registrar of Companies in Hong Kong. Accordingly, this prospectus may not be issued, circulated or distributed in Hong Kong, and the securities may not be offered for subscription to members of the public in Hong Kong. Each person acquiring the securities will be required, and is deemed by the acquisition of the securities, to confirm that he is aware of the restriction on offers of the securities described in this prospectus and the relevant offering documents and that he is not acquiring, and has not been offered any securities in circumstances that contravene any such restrictions.
Japan
The offering has not been and will not be registered under the Financial Instruments and Exchange Law of Japan (Law No. 25 of 1948 of Japan, as amended), or FIEL, and the Initial Purchaser will not offer or sell any securities, directly or indirectly, in Japan or to, or for the benefit of, any resident of Japan (which term as used herein means, unless otherwise provided herein, any person resident in Japan, including any corporation or other entity organized under the laws of Japan), or to others for re-offering or resale, directly or indirectly, in Japan or to a resident of Japan, except pursuant to an exemption from the registration requirements of, and otherwise in compliance with, the FIEL and any other applicable laws, regulations and ministerial guidelines of Japan.
Singapore
This prospectus has not been and will not be lodged or registered with the Monetary Authority of Singapore. Accordingly, this prospectus and any other document or material in connection with the offer or sale, or the invitation for subscription or purchase of the securities may not be issued, circulated or distributed, nor may the securities be offered or sold, or be made the subject of an invitation for subscription or purchase, whether directly or indirectly, to the public or any member of the public in Singapore other than (i) to an institutional investor under Section 274 of the Securities and Futures Act, Chapter 289 of Singapore, or the SFA, (ii) to a relevant person as defined under Section 275(2), 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.
Where the securities are subscribed or purchased under Section 275 of the SFA by a relevant person which is:
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a corporation (which is not an accredited investor as defined under Section 4A of the SFA) 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; or
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a trust (where the trustee is not an accredited investor) whose sole purpose is to hold investments and each beneficiary is an accredited investor,
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shares, debentures and units of shares and debentures of that corporation or the beneficiaries’ rights and interest in that trust shall not be transferable for six months after that corporation or that trust has acquired the Offer Shares under Section 275 of the SFA except:
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to an institutional investor under Section 274 of the SFA or to a relevant person defined in Section 275(2) of the SFA, or to any person pursuant to an offer that is made on terms that such shares, debentures and units of shares and debentures of that corporation or such rights
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and interest in that trust are acquired at a consideration of not less than $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, and further for corporations, in accordance with the conditions, specified in Section 275 of the SFA;
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where no consideration is given for the transfer; or
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where the transfer is by operation of law.
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Switzerland
The securities may not be publicly offered in Switzerland and will not be listed on the SIX Swiss Exchange, or SIX, or on any other stock exchange or regulated trading facility in Switzerland. This prospectus has been prepared without regard to the disclosure standards for issuance prospectuses under art. 652a or art. 1156 of the Swiss Code of Obligations or the disclosure standards for listing prospectuses under art. 27 ff. of the SIX Listing Rules or the listing rules of any other stock exchange or regulated trading facility in Switzerland. Neither this prospectus nor any other offering or marketing material relating to the securities or the offering may be publicly distributed or otherwise made publicly available in Switzerland.
Neither this prospectus nor any other offering or marketing material relating to the offering, the Company or the securities have been or will be filed with or approved by any Swiss regulatory authority. In particular, this prospectus will not be filed with, and the offer of securities will not be supervised by, the Swiss Financial Market Supervisory Authority FINMA, or FINMA, and the offer of securities has not been and will not be authorized under the Swiss Federal Act on Collective Investment Schemes, or CISA. The investor protection afforded to acquirers of interests in collective investment schemes under the CISA does not extend to acquirers of securities.
United Kingdom
This prospectus is only being distributed to, and is only directed at, persons in the United Kingdom that are qualified investors within the meaning of Article 2(1)(e) of the Prospectus Directive that are also (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended, referred to herein as the Order, and/or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order and other persons to whom it may lawfully be communicated. Each such person is referred to herein as a Relevant Person.
This prospectus and its contents are confidential and should not be distributed, published or reproduced (in whole or in part) or disclosed by recipients to any other persons in the United Kingdom. Any person in the United Kingdom that is not a Relevant Person should not act or rely on this document or any of its contents.
LEGAL MATTERS
The validity of the issuance of our common stock offered in this prospectus will be passed upon for us by Morrison & Foerster LLP, 755 Page Mill Road, Palo Alto, California 94304. Latham & Watkins LLP, 140 Scott Drive, Menlo Park, CA 94025 is acting as counsel for the underwriters in connection with this offering.
EXPERTS
The financial statements of the Company at
December 31, 2016
and 2015, and for each of the two years in the period ended
December 31, 2016
, appearing in this Prospectus and Registration Statement have been audited by Mayer Hoffman McCann P.C., independent registered public accounting firm, as set forth in their report thereon appearing elsewhere herein, and are included in reliance upon such report given on 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 shares of common stock offered hereby. This prospectus, which constitutes a part of the registration statement, does not contain all of the information set forth in the registration statement or the exhibits and schedules filed therewith. For further information with respect to us and the common stock offered hereby, reference is made to the registration statement and the exhibits and schedules filed therewith. Statements contained in this prospectus regarding the contents of any contract or any other document that is filed as an exhibit to the registration statement are not necessarily complete, and each such statement is qualified in all respects by reference to the full text of such contract or other document filed as an exhibit to the registration statement. A copy of the registration statement and the exhibits and schedules filed therewith may be inspected without charge at the public reference room maintained by the SEC, located at 100 F Street N.E., Room 1580, Washington, D.C. 20549, and copies of all or any part of the registration statement may be obtained from such offices upon the payment of the fees prescribed by the SEC. Please call the SEC at 1‑800‑SEC‑0330 for further information about the public reference room. The SEC also maintains a website that contains reports, proxy and information statements and other information regarding registrants that file electronically with the SEC. The address is www.sec.gov.
Upon the closing of this offering, we will become subject to the information and periodic reporting requirements of the Exchange Act and, in accordance therewith, will file periodic reports, proxy statements and other information with the SEC. Such periodic reports, proxy statements and other information will be available for inspection and copying at the public reference room and website of the SEC referred to above. We maintain a website at www.MenloTherapeutics.com. Upon completion of this offering, you may access our annual reports on Form 10‑K, quarterly reports on Form 10‑Q, current reports on Form 8‑K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act with the SEC free of charge at our website as soon as reasonably practicable after such material is electronically filed with, or furnished to, the SEC. The information on our website address is not part of this prospectus, and you should not consider the contents of our website in making an investment decision with respect to our common stock.
Index to Financial Statements
Menlo Therapeutics Inc.
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of
Menlo Therapeutics Inc.
We have audited the accompanying balance sheets of Menlo Therapeutics Inc. (the “Company”) as of
December 31, 2016
and 2015, and the related statements of operations and comprehensive loss, changes in convertible preferred stock and stockholders’ deficit, and cash flows for the years then ended. These financial statements are the responsibility of the Company’s 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 Company’s internal control over financial reporting. Accordingly, we express no such opinion.
An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes 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 Menlo Therapeutics Inc. as of
December 31, 2016
and 2015, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.
/s/ Mayer Hoffman McCann P.C.
San Diego, California
October 29, 2017 (except for subsequent events noted in Note 12, as to which the date is December 28, 2017)
Menlo Therapeutics Inc.
Balance Sheets
(in thousands, except share and per share data)
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December 31,
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2015
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2016
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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43,808
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$
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4,027
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Short‑term investments
|
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—
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26,881
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Prepaid expenses and other current assets
|
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77
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632
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Total current assets
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43,885
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31,540
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Long‑term investments
|
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—
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10,420
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Property and equipment, net
|
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—
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27
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Prepaid and other long‑term assets
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—
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66
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Total assets
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$
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43,885
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$
|
42,053
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LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
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Current liabilities:
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Accounts payable
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$
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637
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$
|
1,526
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Accrued expenses and other current liabilities
|
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133
|
|
|
581
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|
Deferred revenue, current
|
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—
|
|
|
1,796
|
|
Total current liabilities
|
|
770
|
|
|
3,903
|
|
|
|
|
|
|
Deferred revenue, long‑term
|
|
—
|
|
|
8,531
|
|
Other non‑current liabilities
|
|
65
|
|
|
57
|
|
Total liabilities
|
|
835
|
|
|
12,491
|
|
|
|
|
|
|
Commitments and contingencies (see Note 5)
|
|
|
|
|
|
|
|
|
|
Series A convertible preferred stock, $0.001 par value, 14,300 shares authorized at December 31, 2015 and 2016; 14,300 shares issued and outstanding at December 31, 2015 and 2016; Liquidation value of $14,300 as of December 31, 2015 and 2016
|
|
14,183
|
|
|
14,183
|
|
Series B convertible preferred stock, $0.001 par value, 14,106,583 shares authorized at December 31, 2015 and 2016; 14,106,583 shares issued and outstanding at December 31, 2015 and 2016; Liquidation value of $45,000 as of December 31, 2015 and 2016
|
|
44,820
|
|
|
44,820
|
|
Stockholders’ deficit:
|
|
|
|
|
Common stock, $0.0001 par value, 36,500,000 shares authorized at December 31, 2015 and 2016; 14,242,980 shares issued and outstanding at December 31, 2015 and 2016
|
|
1
|
|
|
1
|
|
Additional paid‑in capital
|
|
93
|
|
|
699
|
|
Accumulated other comprehensive loss
|
|
—
|
|
|
(26
|
)
|
Accumulated deficit
|
|
(16,047
|
)
|
|
(30,115
|
)
|
Total stockholders’ deficit
|
|
(15,953
|
)
|
|
(29,441
|
)
|
Total liabilities, convertible preferred stock and stockholders’ deficit
|
|
$
|
43,885
|
|
|
$
|
42,053
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
F-3
Menlo Therapeutics Inc.
Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
2015
|
|
2016
|
Collaboration and license revenue
|
|
$
|
—
|
|
|
$
|
674
|
|
Operating expenses:
|
|
|
|
|
Research and development
|
|
2,921
|
|
|
11,255
|
|
General and administrative
|
|
1,687
|
|
|
3,751
|
|
Total operating expenses
|
|
4,608
|
|
|
15,006
|
|
Loss from operations
|
|
(4,608
|
)
|
|
(14,332
|
)
|
Interest income and other expense, net
|
|
—
|
|
|
264
|
|
Net loss attributable to common stockholders
|
|
$
|
(4,608
|
)
|
|
$
|
(14,068
|
)
|
Other comprehensive loss:
|
|
|
|
|
Unrealized loss on available‑for‑sale securities
|
|
—
|
|
|
(26
|
)
|
Comprehensive loss
|
|
$
|
(4,608
|
)
|
|
$
|
(14,094
|
)
|
Net loss attributable to common stockholder per share, basic and diluted
|
|
$
|
(0.36
|
)
|
|
$
|
(1.05
|
)
|
Weighted‑average number of common shares used to compute basic and diluted net loss per share
|
|
12,772,388
|
|
|
13,429,823
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
F-4
Menlo Therapeutics Inc.
Statements of Convertible Preferred Stock and Stockholders’ Deficit
(in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A Convertible
Preferred Stock
|
|
Series B Convertible
Preferred Stock
|
|
Common Stock
|
|
Additional
Paid-in
Capital
|
|
Accumulated
Deficit
|
|
Other
Comprehensive
Loss
|
|
Stockholders’
Deficit
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
Balance at January 1, 2015
|
11,500
|
|
|
$
|
11,383
|
|
|
—
|
|
|
$
|
—
|
|
|
13,386,780
|
|
|
$
|
1
|
|
|
$
|
28
|
|
|
$
|
(11,439
|
)
|
|
$
|
—
|
|
|
$
|
(11,410
|
)
|
Issuance of Series A convertible preferred stock
|
2,800
|
|
|
2,800
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Issuance of Series B convertible preferred stock, net of issuance costs of $179
|
—
|
|
|
—
|
|
|
14,106,583
|
|
|
44,820
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Exercise of unvested stock options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
856,200
|
|
|
—
|
|
|
—
|
|
|
|
|
|
|
|
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
65
|
|
|
—
|
|
|
—
|
|
|
65
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,608
|
)
|
|
—
|
|
|
(4,608
|
)
|
Balance at December 31, 2015
|
14,300
|
|
|
14,183
|
|
|
14,106,583
|
|
|
44,820
|
|
|
14,242,980
|
|
|
1
|
|
|
93
|
|
|
(16,047
|
)
|
|
—
|
|
|
(15,953
|
)
|
Vesting of early exercised stock options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
33
|
|
|
—
|
|
|
—
|
|
|
33
|
|
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
573
|
|
|
—
|
|
|
—
|
|
|
573
|
|
Unrealized loss on available-for-sale securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(26
|
)
|
|
(26
|
)
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(14,068
|
)
|
|
—
|
|
|
(14,068
|
)
|
Balance at December 31, 2016
|
14,300
|
|
|
$
|
14,183
|
|
|
14,106,583
|
|
|
$
|
44,820
|
|
|
14,242,980
|
|
|
$
|
1
|
|
|
$
|
699
|
|
|
$
|
(30,115
|
)
|
|
$
|
(26
|
)
|
|
$
|
(29,441
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
F-5
Menlo Therapeutics Inc.
Statements of Cash Flows
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
2015
|
|
2016
|
Operating activities
|
|
|
|
|
Net loss
|
|
$
|
(4,608
|
)
|
|
$
|
(14,068
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
Depreciation and amortization
|
|
—
|
|
|
4
|
|
Unrealized loss on available‑for‑sale investments
|
|
—
|
|
|
(26
|
)
|
Amortization of premium on investment securities
|
|
—
|
|
|
158
|
|
Stock‑based compensation expense
|
|
65
|
|
|
573
|
|
Change in operating assets and liabilities:
|
|
|
|
|
Prepaid expenses and other current assets
|
|
(22
|
)
|
|
(555
|
)
|
Prepaid and other long‑term assets
|
|
—
|
|
|
(66
|
)
|
Accounts payable
|
|
—
|
|
|
889
|
|
Accrued expenses and other current liabilities
|
|
346
|
|
|
466
|
|
Deferred revenue
|
|
36
|
|
|
10,327
|
|
Other non‑current liabilities
|
|
—
|
|
|
7
|
|
Net cash used in operating activities
|
|
(4,183
|
)
|
|
(2,291
|
)
|
|
|
|
|
|
Investing activities
|
|
|
|
|
Purchase of property and equipment
|
|
—
|
|
|
(31
|
)
|
Purchase of investments
|
|
—
|
|
|
(55,309
|
)
|
Proceeds from sales of investments
|
|
—
|
|
|
3,600
|
|
Proceeds from maturities of investments
|
|
—
|
|
|
14,250
|
|
Net cash used in investing activities
|
|
—
|
|
|
(37,490
|
)
|
|
|
|
|
|
Financing activities
|
|
|
|
|
Proceeds from issuance of convertible preferred stock, net of issuance costs
|
|
47,620
|
|
|
—
|
|
Proceeds from the exercise of stock options
|
|
98
|
|
|
—
|
|
Net cash provided by financing activities
|
|
47,718
|
|
|
—
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
43,535
|
|
|
(39,781
|
)
|
|
|
|
|
|
Cash and cash equivalents at beginning of period
|
|
273
|
|
|
43,808
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
43,808
|
|
|
$
|
4,027
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
F-6
Menlo Therapeutics Inc.
Notes to Financial Statements
|
|
1.
|
Formation and Business of the Company
|
Menlo Therapeutics Inc., or the “Company”, is a late‑stage biopharmaceutical company focused on the development and commercialization of serlopitant for the treatment of pruritus, or itch, associated with dermatologic conditions such as atopic dermatitis, psoriasis and prurigo nodularis. The Company is concurrently evaluating the use of serlopitant for the treatment of refractory chronic cough, a cough that persists for at least eight weeks despite treatment of any identified underlying cause. The Company believes that its product candidate, serlopitant, a highly selective once‑daily, oral small molecule inhibitor of the neurokinin 1 receptor, or NK
1
‑R, has the potential to significantly alleviate itch and cough symptoms. Pruritus associated with atopic dermatitis, psoriasis and prurigo nodularis, as well as refractory chronic cough, each represents a significant patient need.
The Company was incorporated in Delaware in October 2011. Since commencing operations, the Company has devoted substantially all of its resources to developing its product candidate, including conducting clinical trials and providing general and administrative support for these operations.
Liquidity and Capital Resources
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. Since inception, the Company has incurred losses and negative cash flows from operations. For the year ended
December 31, 2016
, the Company incurred a net loss of
$14.1 million
and used
$2.3 million
of cash in operations. As of
December 31, 2016
, the Company had cash, cash equivalents and investments of
$41.3 million
and an accumulated deficit of
$30.1 million
.
Management expects to continue to incur additional substantial losses in the foreseeable future as a result of the Company’s research and development activities. Management plans to finance operations through equity or debt financing arrangements, and/or third‑party collaboration funding. There can be no assurances that, in the event that the Company requires additional financing, such financing will be available on terms which are favorable to the Company, or at all. If the Company is unable to raise additional funding to meet its working capital needs in the future, it will be forced to delay or reduce the scope of its research programs and/or limit or cease its operations.
In July 2017, the Company sold
11,854,463
shares of Series C convertible preferred stock for
$50.5 million
. The Company believes that its existing cash, cash equivalents and investments as of
December 31, 2016
together with funds available from the July 2017 sale of preferred stock, will provide sufficient funds to enable it to meet its obligations for at least the next twelve months.
|
|
2.
|
Significant Accounting Policies
|
Basis of Presentation
These financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented.
Segments
The Company operates in one segment. Management uses one measurement of profitability and does not segregate its business for internal reporting. All long‑lived assets are maintained in the United States of America.
Use of Estimates
Preparation of financial statements in conformity with U.S. GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting periods covered by the financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, stock‑based compensation expense, the resolution of uncertain tax positions and valuation allowance, recovery of long‑lived assets and accruals for research and
development costs. Management bases its estimates on historical experience on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates.
Risk and Uncertainties
The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of results of clinical trials and reaching milestones, uncertainty of regulatory approval of the Company’s potential drug candidate, uncertainty of market acceptance of the Company’s product candidate, competition from substitute products and larger companies, securing and protecting proprietary technology, strategic relationships and dependence on key individuals and sole source suppliers.
The Company’s product candidate requires clearances from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance that the product candidate will receive the necessary clearances. If the Company was denied clearance, clearance was delayed or the Company was unable to maintain clearance, it could have a materially adverse impact on the Company.
The Company expects to incur substantial operating losses for the next several years and will need to obtain additional financing in order to complete clinical studies and launch and commercialize any product candidates for which it receives regulatory approval. There can be no assurance that such financing will be available or will be at terms acceptable by the Company.
Cash and Cash Equivalents
Cash and cash equivalents are stated at fair value. Cash equivalents include only securities having an original maturity of three months or less at the time of purchase. The Company limits its credit risk associated with cash and cash equivalents by placing its investments with an institution it believes is highly creditworthy and with highly rated money market funds. As of December 31, 2015 and 2016, cash and cash equivalents consisted of bank deposits, cash and investments in money market funds.
Investment Securities
The Company classifies its investment securities as available‑for‑sale. Those investments with maturities less than 12 months at the date of purchase are considered short‑term investments. Those investments with maturities greater than 12 months at the date of purchase are considered long‑term investments. The Company’s investment securities classified as available‑for‑sale are recorded at fair value based upon quoted market prices at period end. Unrealized gains and losses, deemed temporary in nature, are reported as a separate component of comprehensive income or loss.
A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the security. Premiums (discounts) are amortized (accreted) over the life of the related security as an adjustment to yield using the straight‑line interest method. Dividend and
interest income are recognized when earned. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of securities sold.
Property and Equipment, Net
Property and equipment are stated at cost and depreciated using the straight‑line method over the estimated useful lives of the assets, generally between
three
and
five
years. Maintenance and repairs are charged to expense as incurred, and improvements are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in operations in the period realized.
Fair Value of Financial Instruments
The carrying amounts of the Company’s financial instruments, which include cash, accounts payable and accrued liabilities and other current liabilities, and deferred revenue approximate their fair values due to their short maturities.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash, cash equivalents and investments. As of December 31, 2015 and 2016, the majority of our cash and cash equivalents and investments are held by one U.S. financial institution in excess of federally insured limits. We invest cash in excess of our current needs in United States Treasury and government agency securities, highly‑rated short or medium‑term debt securities and money market funds and, by policy, diversify our investments to limit the amount of credit exposure.
The Company has an investment policy which limits the Company to investing in highly rated corporate and government notes, and no individual investment may comprise more than
5%
of the total portfolio.
Income Taxes
The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. The Company recognizes future tax benefits, measured by enacted tax rates attributable to deductible temporary differences between financial statements and income tax bases of assets and liabilities, and net operating loss carry‑forwards to the extent that realization of such benefits is more likely than not.
The Company records a liability for the difference between the benefit recognized and measured pursuant to the accounting guidance on accounting for uncertain tax positions and the tax position taken or expected to be taken on the Company’s tax return. To the extent that the assessment of such tax positions changes, the change in estimate is recorded in the period in which the determination is made. The Company establishes these liabilities based on estimates of whether, and the extent to which, additional taxes will be due. These liabilities are established when the Company believes that certain positions might be challenged despite the Company’s belief that the tax return positions are fully supportable. The liabilities are adjusted in light of changing facts and circumstances, such as the outcome of tax audits.
Research and Development Expenses
Research and development costs are expensed as incurred. Substantially all of our research and development expenses consist of expenses incurred in connection with the development of serlopitant. These expenses include certain payroll and personnel expenses including stock‑based compensation expense, consulting costs, contract manufacturing costs, and fees paid to clinical research organizations, or CROs, to conduct research and development. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized and recognized as an expense as the goods are delivered or the related services are performed.
The Company estimates non‑clinical study and clinical trial expenses based on the services performed pursuant to contracts with research institutions and clinical research organizations that conduct and manage non‑clinical studies and clinical trials on its behalf. In accruing service fees, the Company estimates 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 the estimate, the Company will adjust the accrual accordingly. Payments made to third parties under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses until the services are rendered.
Patent Costs
The Company has no historical data to support a probable future economic benefit for the arising patent applications, filing and prosecution costs. Therefore, patent costs are expensed as incurred.
Operating Leases
The Company recognizes rent expense on a straight‑line basis over the non‑cancellable term of the operating lease.
Stock-Based Compensation
The Company measures and recognizes compensation expense for all stock‑based awards made to employees, directors and non‑employees, based on estimated fair values recognized using the straight‑line method over the requisite service period.
The fair value of options to purchase common stock granted to employees is estimated on the grant date using the Black‑Scholes option valuation model. The calculation of stock‑based compensation expense requires that the Company make certain assumptions and judgments about a number of complex and subjective variables used in the Black‑Scholes model, including the expected term, expected volatility of the underlying common stock, risk‑free interest rate, as well as estimating future forfeitures of unvested stock options. To the extent actual forfeiture results differ from the estimates, the difference will be recorded as a cumulative adjustment in the period the estimates are revised.
The Company accounts for common stock warrants and options issued to non‑employees under Accounting Standards Codification (“ASC”) 505‑50 Equity‑Equity based payments to Non‑Employees, using the Black‑Scholes option valuation model as they are earned. The fair value of such non‑employee awards is remeasured over the vesting period.
Convertible Preferred Stock
The Company recorded the convertible preferred stock at fair value on the dates of issuance, net of issuance costs. The convertible preferred stock is recorded outside of stockholders’ equity because, in the event of certain deemed liquidation events considered not solely within the Company’s control, such as a merger, acquisition and sale of all or substantially all of the Company’s assets, the convertible preferred stock will become redeemable at the option of the holders.
Comprehensive Income (Loss)
Comprehensive income (loss) is defined as the change in equity of the Company during a period from transactions and other events and circumstances excluding transactions resulting from investments and distributions to owners. Comprehensive loss consists of the net loss and changes in accumulated other comprehensive income, which are comprised of unrealized gains (losses) on available‑for‑sale investments.
Revenue Recognition
To date, the Company’s clinical drug candidates have not been approved for sale by the FDA and the Company has not generated any revenue from product sales.
On August 10, 2016, the Company entered into a license and collaboration agreement with Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd., together referred to as “JT Torii”, which is referred to as the “Collaboration Agreement”. Under the Collaboration Agreement, the Company granted to JT Torii the rights to develop and commercialize products containing serlopitant in Japan for the treatment of diseases and conditions other than nausea or vomiting. In exchange, JT Torii paid an upfront, non‑refundable payment of
$11.0 million
. In addition, the Company is entitled to receive aggregate payments of up to
$28.0 million
upon the achievement of specified development and regulatory milestones, and
$15.0 million
upon the achievement of a commercial milestone, as well as tiered royalties from the mid-single digits up to the mid‑teens on sales of licensed products in Japan. The Company’s performance obligations under the license agreement includes the transfer of intellectual property rights in the form of licenses, obligations to participate on certain development and/or commercialization committees with the collaboration partners and supply manufactured drug product for clinical trials.
The Company recognizes revenue pursuant to the Collaboration Agreement in connection with the clinical development and commercialization of products covered by the collaboration, including non-refundable upfront license fees, contingent consideration payments based on the achievement of defined collaboration objectives and royalties on sales of commercialized products. To date, the Company has not generated or recognized revenue from sales of its product candidates.
Revenue from the Collaboration Agreement is recognized when
|
|
(i)
|
persuasive evidence of an arrangement exists,
|
|
|
(ii)
|
transfer of technology has been completed, services have been performed or products have been delivered,
|
|
|
(iii)
|
the fee is fixed and determinable, and
|
|
|
(iv)
|
collection is reasonably assured.
|
The Company evaluates revenue agreements with multiple‑elements in accordance with ASC 605-25
Revenue Recognition - Multiple Element Arrangements
. The Company identifies the deliverables included within the agreement and evaluates which deliverables represent separate units of accounting based on the achievement of certain criteria including whether the deliverable has stand‑alone value.
Upfront payments for licenses are evaluated to determine if the licensee can obtain standalone value from the license separate from the value of the research and development services and other deliverables in the arrangement to be provided by the Company. The assessment of multiple-element arrangements also requires judgment in order to determine the allocation of revenue to each deliverable and the appropriate period of time over which the revenue should be recognized.
Under the Collaboration Agreement, the Company has determined that the license does not have standalone value separate from the research and development services because
JT Torii cannot resell such license on a standalone basis or use the license with its available resources to obtain any economic value without the Company’s participation. T
he license and the services are combined as one unit of accounting and upfront payments are recorded initially as deferred revenue in the balance sheet. Revenue is then recognized on a straight-line basis over an estimated performance period that is consistent with the term of performance obligations, unless the Company determines there is a discernible pattern of performance other than straight-line, in which case the Company uses a proportionate performance method to recognize the revenue over the estimated performance period. The Company is recognizing the upfront fee on a straight-line basis over the initial period of performance of six years, which represents the estimated development period in the territories based on the initial development plan managed by the joint steering committee.
The term of the agreement is through the expiration of the patents associated with serlopitant.
The Company periodically reviews its estimated periods of performance based on the progress under each arrangement and accounts for the impact of any changes in estimated periods of performance on a prospective basis.
At the inception of each agreement that includes milestone payments, including the Collaboration Agreement, the Company evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. The Company evaluates factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. Non‑refundable payments that are contingent upon achievement of a substantive milestone are recognized in their entirety in the period in which the milestone is achieved, assuming all other revenue recognition criteria are met. Other contingent payments in which a portion of the milestone consideration is refundable or adjusts based on future performance or non‑performance (e.g., through a penalty or claw‑back provision) are not considered to relate solely to past performance, and therefore, not considered substantive. Amounts that are not recognized as revenue due to the uncertainty as to whether they will be retained or because they are expected to be refunded are recorded as a liability. The Company recognizes non‑substantive milestone payments over the remaining estimated period of performance once the milestone is achieved. Contingent payments associated with the achievement of specific objectives in certain contracts that are not considered substantive because the Company does not contribute effort to the achievement of such milestones are recognized as revenue upon achievement of the objective, as long as there are no undelivered elements remaining and no continuing performance obligations by the Company, assuming all other revenue recognition criteria are met.
Under the Collaboration Agreement, the Company is entitled to receive aggregate payments of up to $28.0 million upon the achievement of specified development and regulatory milestones, and $15.0 million upon the achievement of a commercial milestone. Certain of the milestones related to preparation of an IND for submission to regulatory authorities in the territory are considered substantive given that they are triggered by the Company’s performance relative to the achievement of pre-specified, “at risk” milestone events, such as the initiation or successful completion of regulatory development phases. All other milestones are considered non-substantive because the milestone is dependent upon the performance of the collaboration partner rather than the Company.
Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in the Company’s balance sheets. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, current portion. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion.
Net Loss per Share of Common Stock
Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted‑average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted‑average number of common shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, convertible preferred stock and common stock options are considered to be potentially dilutive securities. Because the Company has reported a net loss for the years ended December 31, 2015 and 2016, diluted net loss per common share is the same as basic net loss per common share for those periods.
Recent Accounting Pronouncements
In November 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2016‑18,
Statement of Cash Flows (Topic 230): Restricted Cash (a consensus of the FASB Emerging Issues Task Force)
. The update requires that the 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. ASU 2016‑18 is effective for public entities for annual periods beginning after December 15, 2017, and interim periods within those annual periods. The Company is currently evaluating the effects, if any, that the adoption of this guidance will have on its financial statements.
In March 2016, the FASB issued ASU 2016‑09,
Improvements to Employee Share‑Based Payment Accounting
as part of its simplification initiative, which involves several aspects of accounting for share‑based payment transactions, including the income tax effects, statutory withholding requirements, forfeitures and classification on the statement of cash flows. The standard is effective for companies for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years with early adoption permitted. The Company adopted this standard as of January 1, 2017, and there was no impact to the Company’s financial statements as a result of the adoption.
In February 2016, the FASB issued ASU 2016‑02,
Leases
(ASC 842), which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both parties to a contract (i.e., lessees and lessors). The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight‑line basis over the term of the lease, respectively. A lessee is also required to record a right‑of‑use asset and a lease liability for all leases with a term of greater than twelve months regardless of their classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases today. ASC 842 supersedes the previous leases standard, ASC 840
Leases
. The standard is effective on January 1, 2019, with early adoption permitted. The Company is currently evaluating the effects, if any, that the adoption of this guidance will have on its financial statements.
In January 2016, the FASB issued ASU 2016‑01,
Recognition and Measurement of Financial Assets and Financial Liabilities
, which addresses certain aspects of recognition, measurement, presentation and disclosure of financial instruments. ASU 2016‑01 is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. The Company is currently evaluating the effects, if any, that the adoption of this guidance will have on its financial statements.
In November 2015, the FASB issued ASU 2015‑17,
Balance Sheet Classification of Deferred Taxes
to simplify the presentation of deferred income taxes. The amendments in this update require that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. We have elected to early adopt ASU 2015‑17 as of the beginning of our fourth quarter ended December 31, 2015 on a prospective basis. There was no impact to the balance sheet amounts as a result of early adoption.
In August 2014, the FASB issued ASU 2014‑15 related to Presentation of Financial Statements ‑
Going Concern (Subtopic 205‑40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern
. This update provides guidance about management’s responsibilities in evaluating an entity’s going concern uncertainties, and about the timing and content of related footnote disclosures. Under this amended guidance, an entity’s management should evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. This update is effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early application is permitted. The Company adopted this standard in 2016 and there was no impact on the financial position, results of operations or related financial statement disclosures.
In June 2014, the FASB issued ASU 2014‑12,
Accounting for Share‑Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period
. ASU 2014‑12 requires that a performance target that affects vesting and could be achieved after the requisite service period be treated as a performance condition. ASU 2014‑12 is effective for the Company for the annual period ending after December 15, 2015 with early adoption permitted. The adoption of ASU 2014‑12 did not have a material effect on the Company’s financial statements.
In May 2014, the FASB issued ASU No. 2014‑09,
Revenue from Contracts with Customers (Topic 606)
, which supersedes the revenue recognition requirements in ASC 605,
Revenue Recognition
. This ASU is based on the principle that revenue is recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In August 2015, FASB issued ASU No. 2015‑14,
Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date
, which effectively delayed the adoption date by one year, to an effective date for public entities for annual and interim periods beginning after December 15, 2017. In March, April and May 2016, the FASB issued additional updates to the new revenue standard relating to reporting revenue on a gross versus net basis, identifying performance obligations and licensing arrangements, and narrow‑scope improvements and practical expedients, respectively. The effective date of this additional update is the same as that of ASU 2014‑09. The guidance permits the use of either a retrospective or cumulative effect transition method. The Company has not yet selected a transition method. The Company is still finalizing the analysis to quantify the adoption impact of the provisions of the new standard, but it does not currently expect to have a material impact on the financial position or results of operations. Based on the evaluation of its current collaboration agreement and associated revenue streams, most of the revenue will be recorded consistently under both the current and the new standard. The FASB has issued, and may issue in the future, interpretive guidance which may cause the Company’s evaluation to change. The Company believes it is following an appropriate timeline to allow for proper recognition, presentation and disclosure upon adoption effective the beginning of fiscal year 2018.
There are no other recently issued accounting standards that apply to the Company or that are expected to have a material impact on results of operations, financial condition, or cash flows.
3. Fair Value Measurements
The fair value of our financial instruments reflects the amounts that we estimate we would receive in connection with the sale of an asset or pay in connection with the transfer of a liability in an orderly transaction between market participants at the measurement date (exit price). We disclose and recognize the fair value of our assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements). The guidance establishes three levels of the fair value hierarchy as follows:
Level 1 ‑ Inputs that reflect unadjusted quoted prices in active markets for identical assets or liabilities that we have the ability to access at the measurement date;
Level 2 ‑ Inputs other than quoted prices that are observable for the assets or liability either directly or indirectly, including inputs in markets that are not considered to be active;
Level 3 ‑ Inputs that are unobservable.
Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. Our assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.
During the years presented, the Company has not changed the manner in which it values assets and liabilities that are measured at fair value using Level 3 inputs. The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no transfers within the hierarchy during the years ended
December 31, 2015
and
2016
.
A summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using
|
|
|
Total
Carrying
Value
|
|
Quoted
Prices
in Active
Markets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
December 31, 2016
|
|
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
Money market funds
|
|
$
|
3,808
|
|
|
$
|
3,808
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Corporate notes
|
|
26,108
|
|
|
7,225
|
|
|
18,883
|
|
|
—
|
|
Government notes
|
|
11,193
|
|
|
11,193
|
|
|
—
|
|
|
—
|
|
Total assets
|
|
$
|
41,109
|
|
|
$
|
22,226
|
|
|
$
|
18,883
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
There were no available‑for‑sales securities held by the Company as of
December 31, 2015
.
The Company uses a market approach for determining the fair value of all its Level 1 and Level 2 money market funds and marketable securities. To value its money market funds, the Company values the funds at $1 stable net asset value, which is the market pricing convention for identical assets that the Company has the ability to access.
The investments are classified as available‑for‑sale securities. At
December 31, 2016
, the balance in the Company’s accumulated other comprehensive income was comprised solely of activity related to the Company’s available‑for‑sale securities. There were no realized gains or losses recognized on the sale or maturity of available‑for‑sale securities for the year ended
December 31, 2016
and as a result, the Company did not reclassify any amounts out of accumulated other comprehensive income for the year. The Company has a limited number of available‑for‑sale securities in insignificant loss positions as of
December 31, 2016
, which the Company does not intend to sell and has concluded it will not be required to sell before recovery of the amortized cost for the investment at maturity.
The following table summarizes the available‑for‑sale securities (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized
Cost
|
|
Unrealized
Gains
|
|
Unrealized
Losses
|
|
Fair Value
|
December 31, 2016
|
|
|
|
|
|
|
|
|
Money market funds
|
|
$
|
3,808
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,808
|
|
Corporate notes
|
|
26,134
|
|
|
—
|
|
|
(26
|
)
|
|
26,108
|
|
Government notes
|
|
11,193
|
|
|
—
|
|
|
—
|
|
|
11,193
|
|
|
|
$
|
41,135
|
|
|
$
|
—
|
|
|
$
|
(26
|
)
|
|
$
|
41,109
|
|
|
|
|
|
|
|
|
|
|
|
|
4.
|
Balance Sheets Components
|
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
2015
|
|
2016
|
Accrued personnel expenses
|
|
$
|
—
|
|
|
$
|
273
|
|
Accrued clinical and development expenses
|
|
80
|
|
|
245
|
|
Other
|
|
53
|
|
|
63
|
|
Total
|
|
$
|
133
|
|
|
$
|
581
|
|
|
|
|
|
|
|
|
5.
|
Commitments and Contingencies
|
Legal Matters
The Company’s industry is characterized by frequent claims and litigation, including claims regarding intellectual property. As a result, the Company may be subject to various legal proceedings from time to time. The results of any future litigation cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors. Management is not aware of any pending or threatened litigation.
License Agreement
In December 2012, the Company entered into an exclusive worldwide royalty free license agreement with Merck Sharp & Dohme Corp., or “Merck” for exclusive worldwide rights for the development and commercialization of serlopitant and two other NK
1
‑R antagonists in all human diseases, disorders or conditions, except for the treatment and prevention of nausea or vomiting. The Company paid Merck an upfront non‑refundable, non‑creditable licensing fee of
$1.0 million
dollars and issued to Merck shares of its common stock. In addition, the Company has agreed to make aggregate payments of up to
$25.0 million
dollars upon the achievement of specified development and regulatory milestones.
Future milestone payments are considered to be contingent consideration and will be accrued when the applicable milestone is achieved. Through
December 31, 2016
, no milestones have been achieved under the license agreement.
Leases
The Company conducts its operations using leased office facilities. As of
December 31, 2015
, the Company was on a month to month lease agreement through June 2016, with aggregate lease payments due of
$61,000
. On April 6, 2016, the Company entered into a new lease agreement. The twenty‑six month lease, began on May 1, 2016, and provides 4,000 square feet of office space in Menlo Park, California. Base annual rent is initially approximately
$20,000
per month, with annual increases. The Company has the option to extend the term of the lease for an additional one year period with respect to the entire premises. The Company recognizes rent expense on a straight‑line basis over the respective lease period.
Rent expense for the years ended
December 31, 2016
and
2015
was
$208,000
and
$7,000
, respectively.
As of December 31, 2016, total future minimum lease payments under our operating leases are as follows (in thousands):
|
|
|
|
|
|
|
|
|
Year ending December 31:
|
|
|
2017
|
|
$
|
244
|
|
2018
|
|
124
|
|
Total future minimum lease payments
|
|
$
|
368
|
|
|
|
|
In September 2017, the Company entered into a lease agreement. The thirty‑month lease, beginning on October 1, 2017 provides approximately 14,000 square feet of office space in Redwood City, California. Base annual rent is approximately
$55,000
per month, with annual increases.
Indemnification
As permitted under Delaware law and in accordance with the Company’s bylaws, the Company is required to indemnify its officers and directors for certain events or occurrences while the officer or director is or was serving in such capacity. The Company is also party to indemnification agreements with its directors. The Company believes the fair value of the indemnification rights and agreements is minimal. Accordingly, the Company has not recorded any liabilities for these indemnification rights and agreements as of
December 31, 2016
.
Contingencies
From time to time, we may have certain contingent liabilities that arise in the ordinary course of our business activities. We accrue a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated.
|
|
6.
|
Convertible Preferred Stock
|
As of
December 31, 2016
, the Company’s Certificate of Incorporation, as amended, authorized the Company to issue up to
14,120,883
shares of convertible preferred stock, par value of
$0.001
, of which
14,300
were designated Series A convertible preferred stock and
14,106,583
were designated Series B convertible preferred stock.
From December 2011 through May 2015, the Company issued
14,300
shares of Series A convertible preferred stock to investors at
$1,000
per share with gross proceeds of
$14.3 million
. Purchasers of our Series A convertible preferred stock also received an aggregate of
8.0 million
shares of common stock in connection with the Series A investment.
In November 2015, the Company issued
14,106,583
shares of Series B convertible preferred stock to investors at
$3.19
per share with gross proceeds of
$45.0 million
.
In July 2017, the Company issued
11,854,463
shares of Series C convertible preferred stock to investors at
$4.26
per share with gross proceeds of
$50.5 million
.
The Company had outstanding convertible preferred stock as of the times set forth below as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2016
|
|
|
Shares Authorized
|
|
Shares Issued and Outstanding
|
|
Aggregate Liquidation Preference
(in thousands)
|
Series A
|
|
14,300
|
|
|
14,300
|
|
|
$
|
14,300
|
|
Series B
|
|
14,106,583
|
|
|
14,106,583
|
|
|
45,000
|
|
Total
|
|
14,120,883
|
|
|
14,120,883
|
|
|
$
|
59,300
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2015
|
|
|
Shares Authorized
|
|
Shares Issued and Outstanding
|
|
Aggregate Liquidation Preference
(in thousands)
|
Series A
|
|
14,300
|
|
|
14,300
|
|
|
$
|
14,300
|
|
Series B
|
|
14,106,583
|
|
|
14,106,583
|
|
|
45,000
|
|
Total
|
|
14,120,883
|
|
|
14,120,883
|
|
|
$
|
59,300
|
|
|
|
|
|
|
|
|
Significant terms of the Series A and B convertible preferred stock as of
December 31, 2016
(collectively, the “Preferred Stock”) are as follows:
Liquidation Preference
In the event of any liquidation, dissolution, or winding up of the Company, either voluntary or involuntary, the holders of the then outstanding shares of Series A convertible stock and Series B convertible preferred stock are first entitled to receive the amount of
$1,000.00
and
$3.19
per share, respectively plus all declared but unpaid dividends for such shares, prior and in preference to any distribution of any assets of the Company to the holders of the common stock. If, upon the occurrence of such event, the proceeds distributed among the holders of the Series A and B convertible preferred stock are insufficient to permit the full payment of the aforesaid preferential amounts to each holder the convertible preferred stock, then the entire proceeds legally available for distribution to the convertible preferred stock shall be distributed ratably among the holders of the Series A and B convertible preferred stock in proportion to the full preferential amount that each such holder of convertible preferred stock is otherwise entitled to receive.
Upon completion of the distributions required by the above‑mentioned liquidation preferences, any remaining proceeds shall be distributed among the holders of Series B convertible preferred stock and common stock pro rata based on the number of shares of common stock held by each, assuming full conversion of the Series B convertible preferred stock to common stock at the then‑effective conversion price for such shares.
Dividends
The holders of shares of Series A and B convertible preferred stock are entitled to receive non‑cumulative dividends, out of any assets legally available, prior and in preference to any declaration or payment of any dividend on the common stock, at the applicable dividend rate of
$80.00
per annum for each share of Series A convertible preferred stock and
$0.2552
per annum for each share of Series B convertible preferred stock, all subject to adjustment from time to time for recapitalizations, payable when and if declared by the Company’s
board of directors. The Company has never declared any dividends on its convertible preferred stock.
Voting
The holder of each share of Series B convertible preferred stock are entitled to one vote for each share of common stock into which such preferred stock could then be converted and, with respect to such vote, such holder has full voting rights and powers equal to the voting rights and powers of the holders of common stock and is entitled to notice of any stockholders’ meeting in accordance with the Company’s bylaws. The holders of shares of Series A convertible preferred stock do not have a right to vote, other than as required by Delaware law and for certain directors, as set forth below.
The holders of shares of Series A convertible preferred stock are entitled to elect two of the Company’s directors. The holders of Series B convertible preferred stock are entitled to elect two of the Company’s directors. The holders of outstanding common stock are entitled to elect three of the Company’s directors. The holders of convertible preferred stock and common stock, voting together as a single class, and not as separate series, and on an as converted basis, are entitled to elect any remaining directors of the Company, subject to the approval of the then serving members of the Company’s directors.
Conversion
The holder of each share of convertible preferred stock has the option to convert each share of convertible preferred stock into such number of fully paid and nonassessable shares of common stock as is determined by dividing the applicable original issue price for such series by the applicable conversion price for such series in effect on the date the certificate is surrendered for conversion. Each share of convertible preferred stock shall automatically be converted into shares of common stock at the conversion rate at the time in effect for such series of convertible preferred stock immediately prior to the earlier of (i) sale of the Company’s common stock in a firm commitment underwritten public offering pursuant to a registration statement under the Securities Act of 1933, as amended, with gross proceeds of not less than
$40.0 million
in the aggregate and an offering price to the public of no less than
$6.38
per share, or (ii) upon the receipt by the Corporation of a written request or agreement of the holders of a majority of the outstanding Series A and B convertible preferred stock, voting together as a single class and on an as converted basis.
The conversion price of the convertible preferred stock was initially set at an amount equal to the issue price. The Series B convertible preferred stock conversion price is subject to adjustment for stock dividends, stock splits, re‑capitalization and upon the occurrence of certain triggering events related to anti‑dilution protection rights. In the event that a future preferred stock financing should occur at a price lower than the last preferred financing round, the conversion ratios of the existing preferred stock are changed to protect the ownership position of existing investors.
7. Common Stock
The Company’s Certificate of Incorporation, as amended, authorizes the Company to issue
36,500,000
shares of
$0.0001
par value common stock. Each share of common stock is entitled to one vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when and if declared by the board of directors, subject to the prior rights of holders of all classes of preferred stock outstanding. The Company has never declared any dividends on common stock.
Shares of common stock reserved for issuance are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
2015
|
|
2016
|
Conversion of Series A preferred stock
|
|
14,300
|
|
|
14,300
|
|
Conversion of Series B preferred stock
|
|
14,106,583
|
|
|
14,106,583
|
|
Total conversion of preferred stock
|
|
14,120,883
|
|
|
14,120,883
|
|
Options outstanding
|
|
—
|
|
|
4,006,198
|
|
Options available for future grant under stock option plan
|
|
4,542,875
|
|
|
536,677
|
|
Total
|
|
18,663,758
|
|
|
18,663,758
|
|
|
|
|
|
|
|
|
8.
|
Stock-Based Compensation
|
Under the Company’s 2011 Stock Incentive Plan (the “2011 Plan”), the Company may grant options to purchase common stock, restricted stock awards, or directly issue shares of common stock to employees, directors and consultants of the Company. During 2015, the Company’s board of directors and stockholders approved an increase to the shares available under the 2011 Plan to
5,628,605
shares. Options may be granted at an exercise price per share of not less than
100%
of the fair market value at the date of grant. If an incentive stock option is granted to a stockholder holding
10%
of the Company’s outstanding capitalization, then the purchase or exercise price per share must not be less than
110%
of the fair market value per share of common stock on the grant date. Options granted are exercisable over a maximum term of
10 years
from the date of grant and generally vest over a period of
four years
.
Total stock‑based compensation expense for employees and non‑employees recognized in the statements of operations was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
2015
|
|
2016
|
Research and development
|
|
$
|
1
|
|
|
$
|
257
|
|
General and administrative
|
|
64
|
|
|
316
|
|
Total stock‑based compensation expense
|
|
$
|
65
|
|
|
$
|
573
|
|
|
|
|
|
|
At
December 31, 2016
, there was approximately
$2.1 million
of unamortized compensation expense, which was expected to be recognized over a weighted average period of
3.0 years
.
2011 Plan
The table below summarizes stock option and restricted award activity under the 2011 Plan:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Shares Available for Issuance
|
|
Number of Shares Outstanding
|
|
Weighted-Average Exercise Price
|
|
Weighted- Average Remaining Contractual Term (Years)
|
|
Aggregate Intrinsic Value (in thousands)
|
Balances at January 1, 2015
|
27,030
|
|
|
—
|
|
|
|
|
|
|
|
Authorized
|
5,372,045
|
|
|
|
|
|
|
|
|
|
Granted
|
(856,200
|
)
|
|
856,200
|
|
|
$
|
0.12
|
|
|
|
|
|
Exercised
(1)
|
—
|
|
|
(856,200
|
)
|
|
$
|
0.12
|
|
|
|
|
|
Balances at December 31, 2015
|
4,542,875
|
|
|
—
|
|
|
|
|
|
|
$
|
—
|
|
Granted
|
(4,006,198
|
)
|
|
4,006,198
|
|
|
$
|
0.74
|
|
|
|
|
|
Balances at December 31, 2016
|
536,677
|
|
|
4,006,198
|
|
|
$
|
0.74
|
|
|
9.32
|
|
|
$
|
3,805
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Includes early exercise of
856,200
options during the year ended
December 31, 2015
, of which
588,638
remain unvested as of
December 31, 2016
.
|
Additional information regarding options outstanding at December 31, 2016 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding
|
|
Options Vested
|
Exercise Price
|
Number of
Shares
|
|
Weighted-
Average
Remaining
Contractual
Life (Years)
|
|
Weighted-
Average
Exercise
Price
|
|
Number of
Shares
|
|
Weighted-
Average
Exercise
Price
|
$0.68
|
3,629,818
|
|
|
9.25
|
|
|
$
|
0.68
|
|
|
702,425
|
|
|
$
|
0.68
|
|
$1.32
|
376,380
|
|
|
9.92
|
|
|
$
|
1.32
|
|
|
4,109
|
|
|
$
|
1.32
|
|
$0.68 ‑ $1.32
|
4,006,198
|
|
|
9.32
|
|
|
$
|
0.74
|
|
|
706,534
|
|
|
$
|
0.68
|
|
|
|
|
|
|
|
|
|
|
|
Upon vesting of restricted shares and exercise of options, the Company issues common stock from its authorized shares. During the years ended
December 31, 2015
and 2016, the Company received
$98,000
and
$0
upon the exercise of stock options, respectively. There were
874,948
and
599,053
shares of early exercised restricted shares which have not vested at
December 31, 2015
and 2016, respectively. As of
December 31, 2015
and 2016, the Company had recorded a liability of
$98,000
and
$68,000
, respectively for the early exercise of stock options, recorded as other current liabilities and other non‑current liabilities. When options are subject to the Company’s repurchase right, the Company may buy back any unvested shares at their original exercise price in the event of an employee’s termination prior to full vesting.
The aggregate grant date fair value of employee options vesting during the years ended
December 31, 2015
and 2016 was approximately
$1,000
and
$182,000
, respectively. The aggregate intrinsic value of shares exercised during the year ended
December 31, 2015
was
zero
. There were
no
shares exercised in the year ended
December 31, 2016
.
Stock Awards Granted to Employees and Directors
Stock‑based compensation expense is based on the grant date fair value. The Company recognizes compensation expense for all stock‑based options and restricted awards on a straight‑line basis over the requisite service period of the awards, which is generally the option vesting term of four years. Stock‑ based compensation expense related to awards granted to employees and directors for the years ended
December 31, 2015
and 2016 was approximately
$1,000
and
$314,000
, respectively.
The Company uses the Black‑Scholes option valuation model, which requires the use of highly subjective assumptions to determine the fair value of stock‑based awards. The assumptions used in the Company’s option‑pricing model represent management’s best estimates. These estimates are complex, involve a number of variables, uncertainties and assumptions and the application of management’s judgment. If factors change and different assumptions are used, the Company’s stock‑based compensation expense could be materially different in the future. The assumptions and estimates that the Company uses in the Black‑Scholes model are as follows:
|
|
▪
|
Fair Value of Common Stock
. The estimated fair value of the common stock underlying the Company’s stock options was determined at each grant date by our board of directors, with input from management. All options to purchase shares of our common stock are intended to be exercisable at a price per share not less than the per‑share fair value of our common stock underlying those options on the date of grant. In the absence of a public trading market for the Company’s common stock, on each grant date, we develop an estimate of the fair value of our common stock based on the information known to the Company on the date of grant, upon a review of any recent events and their potential impact on the estimated fair value per share of the common stock and in part on input from an independent third‑party valuation. The board of directors intended all options granted to be exercisable at a price per share not less than the estimated per share fair value of common stock underlying those options on the date of grant.
|
|
|
▪
|
Risk‑Free Interest Rate
. The Company bases the risk‑free interest rate used in the Black‑Scholes valuation model on the implied yield available on U.S. Treasury zero‑coupon issues with a term equivalent to that of the expected term of the options for each option group.
|
|
|
▪
|
Expected Term
. The expected term represents the period that the Company’s stock‑based awards are expected to be outstanding. Because of the limitations on the sale or transfer of the Company’s common stock as a privately held company, the Company does not believe its historical exercise pattern is indicative of the pattern it will experience as a publicly traded company. The Company has consequently used the Staff Accounting Bulletin 110, or SAB 110, simplified method to calculate the expected term, which is the average of the contractual term and vesting period. The Company plans to continue to use the SAB 110 simplified method until it has sufficient trading history as a publicly traded company.
|
|
|
▪
|
Volatility
. The Company determines the price volatility based on the historical volatilities of industry peers as it has no trading history for its common stock price. Industry peers consist of several public companies in the biotechnology industry with comparable characteristics, including clinical trials progress and therapeutic indications.
|
|
|
▪
|
Dividend Yield
. The expected dividend assumption is based on the Company’s current expectations about its anticipated dividend policy. To date, the Company has not declared any dividends, and therefore the Company has used an expected dividend yield of zero.
|
In addition to the assumptions used in the Black‑Scholes valuation model, the Company must also estimate a forfeiture rate to calculate the stock‑based compensation for its equity awards. The Company will continue to use judgment in evaluating the assumptions related to the Company’s stock‑based compensation on a prospective basis. As the Company continues to accumulate additional data, it may have refinements to its estimates, which could materially impact the Company’s future stock‑based compensation expense.
The following assumptions were used to calculate the fair value of awards granted to employees and directors during the years indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
2015
|
|
2016
|
Expected term (in years)
|
|
3.1
|
|
4.6 - 6.1
|
Volatility
|
|
74%
|
|
68% - 74%
|
Risk‑free interest rate
|
|
1.0%
|
|
1.3% - 2.1%
|
Dividend yield
|
|
—
|
|
—
|
|
|
|
|
|
Stock-Based Compensation for Non-employees
Stock‑based compensation expense related to stock awards granted to non‑employees is recognized as the awards vest. The Company believes that the fair value of the stock‑based awards granted is more reliably measurable than the fair value of the services received. The fair value of stock awards granted is calculated using the Black‑Scholes option valuation model. Stock‑ based compensation expense related to awards granted to non‑employees for the years ended
December 31, 2015
and 2016 was approximately
$64,000
and
$259,000
, respectively.
The fair values of common stock awards granted to non‑employees were calculated using the following assumptions for the periods presented:
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
2015
|
|
2016
|
Expected term (in years)
|
|
1.0 - 1.8
|
|
9.3 - 10.0
|
Volatility
|
|
62% - 74%
|
|
84% - 86%
|
Risk‑free interest rate
|
|
0.5% - 0.7%
|
|
1.6% - 2.5%
|
Dividend yield
|
|
—
|
|
—
|
|
|
|
|
|
|
|
9.
|
Net Loss per Share Attributable to Common Stockholders
|
The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders (in thousands, except share and per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
2015
|
|
2016
|
Numerator:
|
|
|
|
|
Net loss attributable to common stockholders, basic and diluted
|
|
$
|
(4,608
|
)
|
|
$
|
(14,068
|
)
|
Denominator:
|
|
|
|
|
Weighted‑average common shares outstanding
|
|
13,651,850
|
|
|
14,242,980
|
|
Less: weighted‑average common shares subject to repurchase
|
|
(879,462
|
)
|
|
(813,157
|
)
|
Weighted‑average common shares used to compute basic and diluted net loss per share
|
|
12,772,389
|
|
|
13,429,823
|
|
Net loss per share attributable to common stockholders:
|
|
|
|
|
Basic and diluted
|
|
$
|
(0.36
|
)
|
|
$
|
(1.05
|
)
|
|
|
|
|
|
The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
2015
|
|
2016
|
Convertible preferred stock
|
|
14,120,883
|
|
|
14,120,883
|
|
Outstanding common stock subject to repurchase
|
|
874,948
|
|
|
599,053
|
|
Stock options outstanding
|
|
—
|
|
|
4,006,198
|
|
Stock options available for issuance
|
|
4,542,875
|
|
|
536,677
|
|
Total
|
|
19,538,706
|
|
|
19,262,811
|
|
|
|
|
|
|
The Company did not record a provision or benefit for income taxes during the years ended December 31, 2015, and 2016.
The tax effect of temporary differences and carryforwards that give rise to significant portions of the deferred tax assets are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
2015
|
|
2016
|
Deferred Tax Assets
|
|
|
|
|
NOLs
|
|
$
|
5,992
|
|
|
$
|
10,458
|
|
Depreciation and Amortization
|
|
362
|
|
|
328
|
|
Stock‑Based Compensation
|
|
34
|
|
|
161
|
|
Research & Development Credits
|
|
233
|
|
|
586
|
|
Other Accruals
|
|
—
|
|
|
98
|
|
Total Deferred Tax Assets
|
|
$
|
6,621
|
|
|
$
|
11,631
|
|
|
|
|
|
|
Deferred Tax Liabilities
|
|
—
|
|
|
—
|
|
Total Deferred Tax Liabilities
|
|
$
|
—
|
|
|
$
|
—
|
|
Valuation Allowance
|
|
(6,621
|
)
|
|
(11,631
|
)
|
Net Deferred Tax Assets
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
Realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance. The net change in the total valuation allowance for the years ended
December 31, 2015
and
December 31, 2016
was an increase of approximately
$1.9 million
and
$5.0 million
, respectively.
As of
December 31, 2015
and 2016, the Company had net operating loss carryforwards for federal income tax purposes of
$15.0 million
and
$28.2 million
, respectively which expire beginning in the year 2031 and federal research and development tax credits of
$0.2 million
and
$0.5 million
, respectively which expire beginning in the year 2031.
As of
December 31, 2015
and 2016, the Company had net operating loss carryforwards for state income tax purposes of
$15.0 million
and
$15.0 million
, respectively which expire beginning in the year 2031 and state research and development tax credits of
$0.2 million
and
$0.4 million
, respectively which do not expire.
Federal and state tax laws impose substantial restrictions on the utilization of the net operating loss and credit carryforwards in the event of an ownership change as defined in Section 382 of the Internal Revenue Code. Accordingly, the Company’s ability to utilize these carryforwards may be limited as a result of such ownership change. Such a limitation could result in the expiration of carryforwards before they are utilized.
The Company adopted the ASC Topic 740 provisions regarding Uncertainty in Income Taxes as of January 1, 2011. For benefits to be realized, a tax position must be more likely than not to be sustained upon examination. The amount recognized is measured as the largest amount of benefit that is greater than 50 percent likely of being realized upon settlement. As a result of the implementation of these provisions, the Company did not recognize any adjustments to retained earnings for uncertain tax positions.
It is the Company’s policy to recognize interest and penalties related to income tax matters in income tax
expense. As of
December 31, 2016
, the Company had no accrued interest and penalties related to uncertain tax positions.
The Company filed US and California tax returns with varying statues of limitations. The federal and California tax years from 2011 to 2016 remain open to examination due to the carryover of unused net operating losses and tax credits. The Company does not expect any material changes to the estimated amount of liability associated with its uncertain tax positions within the next 12 months.
Uncertain Tax Positions
The following table summarizes the activity related to unrecognized tax benefits (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31,
|
|
|
2015
|
|
2016
|
Tax Benefits:
|
|
|
|
|
Unrecognized Benefit ‑ beginning of period
|
|
$
|
73
|
|
|
$
|
93
|
|
Gross Increases(Decreases) ‑ prior period tax positions
|
|
—
|
|
|
—
|
|
Gross Increases(Decreases) ‑ current period tax positions
|
|
20
|
|
|
136
|
|
Total Unrecognized Benefit ‑ end of period
|
|
$
|
93
|
|
|
$
|
229
|
|
|
|
|
|
|
|
|
11.
|
Related Party Transactions
|
From 2011 through 2016, the Company has operated with significant consulting and management services provided by Velocity Pharmaceutical Development, LLC (“VPD”). Development services fees paid to VPD under the Development Services Agreement were
$0.8 million
and
$1.0 million
for the years ended
December 31, 2015
and 2016, respectively. The Company also reimbursed VPD for consulting, travel and other expenses incurred on our behalf. As of
December 31, 2015
and 2016, the Company had outstanding liabilities to VPD of
$50,000
and
$0
, respectively. Several managing directors of VPD have served as officers and directors of the Company. David Collier, M.D., a former member of the Company’s board of directors, is the Chief Executive Officer of VPD, and Xiaoming Zhang, Ph.D., our Senior Vice President, Non‑Clinical and Pharmaceutical Development, is a Venture Partner of VPD.
The Company has entered into a services agreement with Theratrophix, which is partially owned by
Dr. Zhang
. During the years ended
December 31, 2015
and 2016, the Company incurred expenses of
$39,000
and
$270,000
, respectively with Theratrophix. As of
December 31, 2015
and 2016, there was an outstanding accounts payable balance of
$39,000
and
$0
, respectively, owed to Theratrophix.
In July 2017, the Company issued and sold
11,854,463
shares of Series C convertible preferred stock receiving an aggregate of
$50.5 million
in gross proceeds. In connection with the sale of the shares, the Company filed new articles of incorporation to increase the authorized shares to
83,322,761
, designating a total of
14,201,878
as Series C convertible preferred stock. The documents effecting the sale and issuance of these shares contain customary voting, registration, right of first refusal and co‑sale rights. In the event of any liquidation, dissolution, or winding up of the Company, either voluntary or involuntary, the holders of the then outstanding shares of Series C convertible stock are first entitled to receive the amount of
$4.26
per share plus all declared but unpaid dividends for such shares, prior and in preference to any distribution of any assets of the Company to the holders of the Series B and Series A convertible preferred stock. The holders of shares of Series C convertible preferred stock are entitled to receive non‑cumulative dividends, out of any assets legally available, prior and in preference to any declaration or payment of any dividend on the common stock, at the applicable dividend rate of
$0.3408
per annum for each share of Series C convertible preferred stock. The Series C convertible preferred shares are convertible into common stock on a one‑for‑one basis at the option of
the holder at any time, and will automatically convert upon an IPO with a minimum price per share of
$6.38
and gross proceeds of at least
$40.0 million
, or upon a majority vote of stockholders.
In September 2017, the Company entered in to a lease agreement. The
thirty
month lease, beginning on October 1, 2017 provides approximately 14,000 square feet of office space in Redwood City, California. Base annual rent is approximately
$55,000
per month, with annual increases.
In September 2017, the Company entered into a new services agreement with JT Torii to provide research and development services, including regulatory, chemistry and manufacturing support and related materials.
In November 2017, the Company recognized $2.0 million of revenue upon achievement of a contingent milestone under the JT Torii Collaboration and License Agreement.
The Company has reviewed and evaluated subsequent events that occurred through December 28, 2017, the date the financial statements were available to be issued, and determined that no additional subsequent events had occurred that would require recognition or disclosure in these financial statements.
Menlo Therapeutics Inc.
Balance Sheets
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2016
|
|
September 30,
2017
|
|
Pro Forma Stockholders’ Equity as of September 30,
2017
|
|
|
|
|
(unaudited)
|
|
(unaudited)
|
ASSETS
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
4,027
|
|
|
$
|
14,958
|
|
|
|
Short‑term investments
|
|
26,881
|
|
|
58,589
|
|
|
|
Accounts receivable
|
|
—
|
|
|
460
|
|
|
|
Prepaid expenses and other current assets
|
|
632
|
|
|
1,775
|
|
|
|
Total current assets
|
|
31,540
|
|
|
75,782
|
|
|
|
Long‑term investments
|
|
10,420
|
|
|
—
|
|
|
|
Property and equipment, net
|
|
27
|
|
|
18
|
|
|
|
Prepaid and other long‑term assets
|
|
66
|
|
|
—
|
|
|
|
Total assets
|
|
$
|
42,053
|
|
|
$
|
75,800
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ (DEFICIT) EQUITY
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
1,526
|
|
|
$
|
3,527
|
|
|
|
Accrued expenses and other current liabilities
|
|
581
|
|
|
1,899
|
|
|
|
Deferred revenue, current
|
|
1,796
|
|
|
1,796
|
|
|
|
Total current liabilities
|
|
3,903
|
|
|
7,222
|
|
|
|
Deferred revenue, long‑term
|
|
8,531
|
|
|
7,184
|
|
|
|
Other non‑current liabilities
|
|
57
|
|
|
25
|
|
|
|
Total liabilities
|
|
12,491
|
|
|
14,431
|
|
|
|
Commitments and contingencies (see Note 5)
|
|
|
|
|
|
|
Series A convertible preferred stock, $0.001 par value, 14,300 shares authorized at December 31, 2016 and September 30, 2017 (unaudited); 14,300 shares issued and outstanding at December 31, 2016 and September 30, 2017 (unaudited); Liquidation value of $14,300 as of December 31, 2016 and September 30, 2017 (unaudited)
|
|
14,183
|
|
|
14,183
|
|
|
$
|
—
|
|
Series B convertible preferred stock, $0.001 par value, 14,106,583 shares authorized at December 31, 2016 and September 30, 2017 (unaudited); 14,106,583 shares issued and outstanding at December 31, 2016 and September 30, 2017 (unaudited); Liquidation value of $45,000 as of December 31, 2016 and September 30, 2017 (unaudited)
|
|
44,820
|
|
|
44,820
|
|
|
—
|
|
Series C convertible preferred stock, $0.001 par value, 0 and 14,201,878 shares authorized at December 31, 2016 and September 30, 2017 (unaudited), respectively; 0 and 11,854,463 shares issued and outstanding at December 31, 2016 and September 30, 2017 (unaudited), respectively; Liquidation value of 0 and $50,500 as of December 31, 2016 and September 30, 2017 (unaudited), respectively
|
|
—
|
|
|
50,327
|
|
|
—
|
|
Preferred stock, $0.0001 par value per share, no shares authorized, issued and outstanding actual; 20,000,000 shares authorized, no shares issued and outstanding, proforma and proforma as adjusted
|
|
—
|
|
|
—
|
|
|
—
|
|
Stockholders’ (deficit) equity:
|
|
|
|
|
|
|
Common stock, $0.0001 par value, 36,500,000 and 55,000,000 shares authorized at December 31, 2016 and September 30, 2017 (unaudited), respectively ; 14,242,980 and 14,292,980 shares issued and outstanding at December 31, 2016 and September 30, 2017 (unaudited), respectively; 300,000,000 shares authorized and 40,268,326 outstanding proforma (unaudited)
|
|
1
|
|
|
1
|
|
|
4
|
|
Additional paid‑in capital
|
|
699
|
|
|
1,968
|
|
|
111,295
|
|
Accumulated other comprehensive loss
|
|
(26
|
)
|
|
(15
|
)
|
|
(15
|
)
|
Accumulated deficit
|
|
(30,115
|
)
|
|
(49,915
|
)
|
|
(49,915
|
)
|
Total stockholders’ (deficit) equity
|
|
(29,441
|
)
|
|
(47,961
|
)
|
|
$
|
61,369
|
|
Total liabilities, convertible preferred stock and stockholders’ (deficit) equity
|
|
$
|
42,053
|
|
|
$
|
75,800
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
F-27
Menlo Therapeutics Inc.
Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
|
2016
|
|
2017
|
|
|
(unaudited)
|
Collaboration and license revenue
|
|
$
|
224
|
|
|
$
|
1,807
|
|
Operating expenses:
|
|
|
|
|
Research and development
|
|
7,178
|
|
|
18,461
|
|
General and administrative
|
|
2,453
|
|
|
3,462
|
|
Total operating expenses
|
|
9,631
|
|
|
21,923
|
|
Loss from operations
|
|
(9,407
|
)
|
|
(20,116
|
)
|
Interest income and other expense, net
|
|
176
|
|
|
316
|
|
Net loss attributable to common stockholders
|
|
$
|
(9,231
|
)
|
|
$
|
(19,800
|
)
|
Other comprehensive loss:
|
|
|
|
|
Unrealized gain on available‑for‑sale securities
|
|
19
|
|
|
11
|
|
Comprehensive loss
|
|
$
|
(9,212
|
)
|
|
$
|
(19,789
|
)
|
Net loss attributable to common stockholder per share, basic and diluted
|
|
$
|
(0.69
|
)
|
|
$
|
(1.44
|
)
|
Weighted‑average number of common shares used to compute basic and diluted net loss per share
|
|
13,370,809
|
|
|
13,720,985
|
|
Pro forma net loss per share attributable to common stockholders, basic and diluted (See Note 9)
|
|
|
|
$
|
(0.64
|
)
|
Pro forma weighted‑average common shares outstanding, basic and diluted (See Note 9)
|
|
|
|
31,108,477
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
F-28
Menlo Therapeutics Inc.
Statement of Convertible Preferred Stock and Stockholders’ Deficit
(in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A Convertible
Preferred Stock
|
|
Series B Convertible
Preferred Stock
|
|
Series C Convertible Preferred Stock
|
|
|
Common Stock
|
|
Additional
Paid-in
Capital
|
|
Accumulated
Deficit
|
|
Other
Comprehensive
Loss
|
|
Stockholders’
Deficit
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
Shares
|
|
Amount
|
|
|
|
|
Balance at December 31, 2016
|
14,300
|
|
|
$
|
14,183
|
|
|
14,106,583
|
|
|
$
|
44,820
|
|
|
—
|
|
|
$
|
—
|
|
|
|
14,242,980
|
|
|
$
|
1
|
|
|
$
|
699
|
|
|
$
|
(30,115
|
)
|
|
$
|
(26
|
)
|
|
$
|
(29,441
|
)
|
Issuance of Series C convertible preferred stock, net of issuance costs of $173 (unaudited)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
11,854,463
|
|
|
50,327
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Issuance of common stock upon exercise of stock options (unaudited)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
50,000
|
|
|
—
|
|
|
34
|
|
|
—
|
|
|
—
|
|
|
34
|
|
Vesting of early exercised stock options (unaudited)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
18
|
|
|
—
|
|
|
—
|
|
|
18
|
|
Stock-based compensation (unaudited)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
1,217
|
|
|
—
|
|
|
—
|
|
|
1,217
|
|
Unrealized gain on available-for-sale securities (unaudited)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
11
|
|
|
11
|
|
Net loss (unaudited)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(19,800
|
)
|
|
—
|
|
|
(19,800
|
)
|
Balance at September 30, 2017 (unaudited)
|
14,300
|
|
|
$
|
14,183
|
|
|
14,106,583
|
|
|
$
|
44,820
|
|
|
11,854,463
|
|
|
$
|
50,327
|
|
|
|
14,292,980
|
|
|
$
|
1
|
|
|
$
|
1,968
|
|
|
$
|
(49,915
|
)
|
|
$
|
(15
|
)
|
|
$
|
(47,961
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
F-29
Menlo Therapeutics Inc.
Statements of Cash Flows
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
|
2016
|
|
2017
|
|
|
(unaudited)
|
Operating activities
|
|
|
|
|
Net loss
|
|
$
|
(9,231
|
)
|
|
$
|
(19,800
|
)
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
|
|
|
|
|
Depreciation and amortization
|
|
2
|
|
|
5
|
|
Unrealized gain on available‑for‑sale investments
|
|
19
|
|
|
11
|
|
Amortization of premium on investment securities
|
|
44
|
|
|
73
|
|
Stock‑based compensation expense
|
|
311
|
|
|
1,217
|
|
Disposal of equipment
|
|
—
|
|
|
19
|
|
Change in operating assets and liabilities:
|
|
|
|
|
Accounts receivable
|
|
—
|
|
|
(460
|
)
|
Prepaid expenses and other current assets
|
|
(534
|
)
|
|
(1,143
|
)
|
Prepaid and other long‑term assets
|
|
—
|
|
|
66
|
|
Accounts payable
|
|
480
|
|
|
2,001
|
|
Accrued expenses and other current liabilities
|
|
373
|
|
|
1,320
|
|
Deferred revenue
|
|
10,776
|
|
|
(1,347
|
)
|
Other non‑current liabilities
|
|
18
|
|
|
(16
|
)
|
Net cash provided by (used in) operating activities
|
|
2,258
|
|
|
(18,054
|
)
|
Investing activities
|
|
|
|
|
Purchase of property and equipment
|
|
(24
|
)
|
|
(15
|
)
|
Purchase of investments
|
|
(49,472
|
)
|
|
(59,171
|
)
|
Proceeds from sales of investments
|
|
1,200
|
|
|
6,000
|
|
Proceeds from maturities of investments
|
|
9,650
|
|
|
31,810
|
|
Net cash used in investing activities
|
|
(38,646
|
)
|
|
(21,376
|
)
|
Financing activities
|
|
|
|
|
Proceeds from issuance of convertible preferred stock, net of issuance costs
|
|
—
|
|
|
50,327
|
|
Proceeds from the exercise of stock options
|
|
—
|
|
|
34
|
|
Net cash provided by financing activities
|
|
—
|
|
|
50,361
|
|
Net increase (decrease) in cash and cash equivalents
|
|
(36,388
|
)
|
|
10,931
|
|
Cash and cash equivalents at beginning of period
|
|
43,808
|
|
|
4,027
|
|
Cash and cash equivalents at end of period
|
|
$
|
7,420
|
|
|
$
|
14,958
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
F-30
Menlo Therapeutics Inc.
Notes to Financial Statements
|
|
1.
|
Formation and Business of the Company
|
Menlo Therapeutics Inc., or the “Company”, is a late‑stage biopharmaceutical company focused on the development and commercialization of serlopitant for the treatment of pruritus, or itch, associated with dermatologic conditions such as atopic dermatitis, psoriasis and prurigo nodularis. The Company is concurrently evaluating the use of serlopitant for the treatment of refractory chronic cough, a cough that persists for at least eight weeks despite treatment of any identified underlying cause. The Company believes that its product candidate, serlopitant, a highly selective once‑daily, oral small molecule inhibitor of the neurokinin 1 receptor, or NK
1
‑R, has the potential to significantly alleviate itch and cough symptoms. Pruritus associated with atopic dermatitis, psoriasis and prurigo nodularis, as well as refractory chronic cough, each represents a significant patient need.
The Company was incorporated in Delaware in October 2011. Since commencing operations, the Company has devoted substantially all of its resources to developing its product candidate, including conducting clinical trials and providing general and administrative support for these operations.
Liquidity and Capital Resources
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. Since inception, the Company has incurred losses and negative cash flows from operations. For the year ended
December 31, 2016
, the Company incurred a net loss of
$14.1 million
and used
$2.3 million
of cash in operations. As of
December 31, 2016
, the Company had cash, cash equivalents and investments of
$41.3 million
and an accumulated deficit of
$30.1 million
. For the
nine
months ended
September 30, 2017
, the Company incurred a net loss of
$19.8 million
and used $18.1 million of cash in operations. As of
September 30, 2017
, the Company had cash, cash equivalents and investments of
$73.5 million
and an accumulated deficit of
$49.9 million
.
Management expects to continue to incur additional substantial losses in the foreseeable future as a result of the Company’s research and development activities. Management plans to finance operations through equity or debt financing arrangements, and/or third‑party collaboration funding. There can be no assurances that, in the event that the Company requires additional financing, such financing will be available on terms which are favorable to the Company, or at all. If the Company is unable to raise additional funding to meet its working capital needs in the future, it will be forced to delay or reduce the scope of its research programs and/or limit or cease its operations.
The Company believes that its existing cash, cash equivalents and investments as of
September 30, 2017
will provide sufficient funds to enable it to meet its obligations for at least the next twelve months.
2. Significant Accounting Policies
Basis of Presentation
These financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented.
Unaudited Interim Financial Information
The accompanying interim balance sheet as of
September 30, 2017
, the statements of operations and comprehensive loss and cash flows for the
nine
months ended
September 30, 2016
and 2017, and the statement of convertible preferred stock and stockholders’ deficit as of
September 30, 2017
and the related interim information contained within the notes to the financial statements, are unaudited. The unaudited interim financial statements have been prepared in accordance with U.S. GAAP and on the same basis as the audited financial statements. In the opinion of management, the accompanying unaudited interim financial statements contain all adjustments which are necessary to state fairly our financial position as of
September 30, 2017
, and the results of our operations and cash flows for the
nine
months ended
September 30, 2016
and 2017. Such adjustments are of a normal and recurring nature. The results for the
nine
months ended
September 30, 2017
are not necessarily indicative of the results to be expected for the full fiscal year 2017, or
for any future period.
Unaudited Pro Forma Balance Sheet Information
The unaudited pro forma stockholders’ equity information in the accompanying balance sheet has been prepared assuming immediately prior to completion of our planned Initial Public Offering, or “IPO”, the conversion of all outstanding shares of convertible preferred stock into shares of our common stock upon a vote of shareholders. Shares of common stock contemplated to be sold in our planned IPO and related net proceeds are excluded from such pro forma information.
Segments
The Company operates in one segment. Management uses one measurement of profitability and does not segregate its business for internal reporting. All long‑lived assets are maintained in the United States of America.
Use of Estimates
Preparation of financial statements in conformity with U.S. GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting periods covered by the financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, stock‑based compensation expense, the resolution of uncertain tax positions and valuation allowance, recovery of long‑lived assets and accruals for research and development costs. Management bases its estimates on historical experience on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates.
Risk and Uncertainties
The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of results of clinical trials and reaching milestones, uncertainty of regulatory approval of the Company’s potential drug candidates, uncertainty of market acceptance of the Company’s product candidate, competition from substitute products and larger companies, securing and protecting proprietary technology, strategic relationships and dependence on key individuals and sole source suppliers.
The Company’s product candidate requires clearances from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance that the product candidate will receive the necessary clearances. If the Company was denied clearance, clearance was delayed or the Company was unable to maintain clearance, it could have a materially adverse impact on the Company.
The Company expects to incur substantial operating losses for the next several years and will need to obtain additional financing in order to complete clinical studies and launch and commercialize any product candidates for which it receives regulatory approval. There can be no assurance that such financing will be available or will be at terms acceptable by the Company.
Cash and Cash Equivalents
Cash and cash equivalents are stated at fair value. Cash equivalents include only securities having an original maturity of three months or less at the time of purchase. The Company limits its credit risk associated with cash and cash equivalents by placing its investments with an institution it believes is highly credit worthy and with highly rated money market funds. As of
September 30, 2017
, cash and cash equivalents consisted of bank deposits, cash and investments in money market funds.
Investment Securities
The Company classifies its investment securities as available‑for‑sale. Those investments with maturities less than 12 months at the date of purchase are considered short‑term investments. Those investments with maturities greater than 12 months at the date of purchase are considered long‑term investments. The
Company’s investment securities classified as available‑for‑sale are recorded at fair value based upon quoted market prices at period end. Unrealized gains and losses, deemed temporary in nature, are reported as a separate component of comprehensive income or loss.
A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the security. Premiums (discounts) are amortized (accreted) over the life of the related security as an adjustment to yield using the straight‑line interest method. Dividend and interest income are recognized when earned. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of securities sold.
Accounts Receivable
Accounts receivable represent amounts owed to the Company under the Collaboration Agreement with JT Torii. The Company had no amounts reserved for doubtful accounts as of September 30, 2017, as the Company expects full collection of the receivable balance.
Property and Equipment, Net
Property and equipment are stated at cost and depreciated using the straight‑line method over the estimated useful lives of the assets, generally between three and five years. Maintenance and repairs are charged to expense as incurred, and improvements are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in operations in the period realized.
Fair Value of Financial Instruments
The carrying amounts of the Company’s financial instruments, which include cash, accounts payable and accrued liabilities and other current liabilities and deferred revenue, approximate their fair values due to their short maturities.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash, cash equivalents and investments. As of December 31, 2016, and
September 30, 2017
the majority of our cash and cash equivalents and investments are held by one U.S. financial institution in excess of federally insured limits. We invest cash in excess of our current needs in United States Treasury and government agency securities, highly‑rated short or medium‑term debt securities and money market funds and, by policy, diversify our investments to limit the amount of credit exposure. The Company has an investment policy which limits the Company to investing in highly rated corporate and government notes, and no individual investment may comprise more than 5% of the total portfolio.
Income Taxes
The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. The Company recognizes future tax benefits, measured by enacted tax rates attributable to deductible temporary differences between financial statements and income tax bases of assets and liabilities, and net operating loss carry‑forwards to the extent that realization of such benefits is more likely than not.
The Company records a liability for the difference between the benefit recognized and measured pursuant to the accounting guidance on accounting for uncertain tax positions and the tax position taken or expected to be taken on the Company’s tax return. To the extent that the assessment of such tax positions changes, the change in estimate is recorded in the period in which the determination is made. The Company establishes these liabilities based on estimates of whether, and the extent to which, additional taxes will be due. These liabilities are established when the Company believes that certain positions might be challenged despite the Company’s belief that the tax return positions are fully supportable. The liabilities are adjusted in light of changing facts and circumstances, such as the outcome of tax audits.
Research and Development Expenses
Research and development costs are expensed as incurred. Substantially all of our research and development expenses consist of expenses incurred in connection with the development of serlopitant. These expenses include certain payroll and personnel expenses including stock‑based compensation expense, consulting costs, contract manufacturing costs and fees paid to clinical research organizations, or CROs, to conduct research and development. Non-refundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized and recognized as an expense as the goods are delivered or the related services are performed.
The Company estimates non‑clinical study and clinical trial expenses based on the services performed pursuant to contracts with research institutions and clinical research organizations that conduct and manage non‑clinical studies and clinical trials on its behalf. In accruing service fees, the Company estimates 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 the estimate, the Company will adjust the accrual accordingly. Payments made to third parties under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses until the services are rendered.
Patent Costs
The Company has no historical data to support a probable future economic benefit for the arising patent applications, filing and prosecution costs. Therefore, patent costs are expensed as incurred.
Operating Leases
The Company recognizes rent expense on a straight‑line basis over the non‑cancellable term of the operating lease.
Stock-Based Compensation
The Company measures and recognizes compensation expense for all stock‑based awards made to employees, directors and non‑employees, based on estimated fair values recognized using the straight‑line method over the requisite service period.
The fair value of options to purchase common stock granted to employees is estimated on the grant date using the Black‑Scholes option valuation model. The calculation of stock‑based compensation expense requires that the Company make certain assumptions and judgments about a number of complex and subjective variables used in the Black‑Scholes model, including the expected term, expected volatility of the underlying common stock, risk‑free interest rate, as well as estimating future forfeitures of unvested stock options. To the extent actual forfeiture results differ from the estimates, the difference will be recorded as a cumulative adjustment in the period the estimates are revised.
The Company accounts for common stock warrants and options issued to non‑employees under Accounting Standards Codification (“ASC”) 505‑50 Equity‑Equity based payments to Non‑Employees, using the Black‑Scholes option valuation model as they are earned. The fair value of such non‑employee awards is remeasured over the vesting period.
Convertible Preferred Stock
The Company recorded the convertible preferred stock at fair value on the dates of issuance, net of issuance costs. The convertible preferred stock is recorded outside of stockholders’ equity because, in the event of certain deemed liquidation events considered not solely within the Company’s control, such as a merger, acquisition and sale of all or substantially all of the Company’s assets, the convertible preferred stock will become redeemable at the option of the holders.
Comprehensive Income (Loss)
Comprehensive income (loss) is defined as the change in equity of the Company during a period from transactions and other events and circumstances excluding transactions resulting from investments and distributions to owners. Comprehensive loss consists of the net loss and changes in accumulated other comprehensive income, which are comprised of unrealized gains (losses) on available‑for‑sale investments.
Revenue Recognition
To date, the Company’s clinical drug candidates have not been approved for sale by the FDA and the Company has not generated any revenue from the sale of products.
On August 10, 2016, the Company entered into a license and collaboration agreement with Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd., together referred to as “JT Torii”, which is referred to as the “Collaboration Agreement”. Under the Collaboration Agreement, the Company granted to JT Torii the rights to develop and commercialize products containing serlopitant in Japan, for the treatment of diseases and conditions other than nausea or vomiting. In exchange, JT Torii paid the Company an upfront, non‑refundable payment of
$11.0 million
. In addition, the Company is entitled to receive aggregate payments of up to
$28.0 million
upon the achievement of specified development and regulatory milestones, and
$15.0 million
upon the achievement of a commercial milestone, as well as tiered royalties from the mid-single digits up to the mid‑teens on sales of licensed products in Japan. The Company’s performance obligations under the license agreement include the transfer of intellectual property rights in the form of licenses, obligations to participate on certain development and/or commercialization committees with the collaboration partners and supply manufactured drug product for clinical trials.
The Company recognizes revenue pursuant to the Collaboration Agreement in connection with the clinical development and commercialization of products covered by the collaboration,
including non-refundable upfront license fees, contingent consideration payments based on the achievement of defined collaboration objectives and royalties on sales of commercialized products. To date, the Company has not generated or recognized revenue from sales of its product candidates.
Revenue from the Collaboration Agreement is recognized when
|
|
(i)
|
persuasive evidence of an arrangement exists,
|
|
|
(ii)
|
transfer of technology has been completed, services have been performed or products have been delivered,
|
|
|
(iii)
|
the fee is fixed and determinable, and
|
|
|
(iv)
|
collection is reasonably assured.
|
The Company evaluates revenue agreements with multiple‑elements in accordance with ASC 605-25 Revenue Recognition - Multiple Element Arrangements. The Company identifies the deliverables included within the agreement and evaluates which deliverables represent separate units of accounting based on the achievement of certain criteria including whether the deliverable has stand‑alone value.
Upfront payments for licenses are evaluated to determine if the licensee can obtain standalone value from the license separate from the value of the research and development services and other deliverables in the arrangement to be provided by the Company. The assessment of multiple-element arrangements also requires judgment in order to determine the allocation of revenue to each deliverable and the appropriate period of time over which the revenue should be recognized.
Under the Collaboration Agreement, the Company has determined that the license does not have standalone value separate from the research and development services because
JT Torii cannot resell such license on a standalone basis or use the license with its available resources to obtain any economic value without the Company’s participation. T
he license and the services are combined as one unit of accounting and upfront payments are recorded initially as deferred revenue in the balance sheet. Revenue is then recognized on a straight-line basis over an estimated performance period that is consistent with the term of performance obligations, unless the Company determines there is a discernible pattern of performance other than straight-line, in which case the Company uses a proportionate performance method to recognize the revenue over the estimated performance period. The Company is recognizing the upfront fee on a straight-line basis over the initial period of performance of six years, which represents the estimated development period in the territories based on the initial development plan managed by the joint steering committee. The term of the agreement is through the expiration of the patents associated with serlopitant.
The Company periodically reviews its estimated
periods of performance based on the progress under each arrangement and accounts for the impact of any changes in estimated periods of performance on a prospective basis.
At the inception of each agreement that includes milestone payments, including the Collaboration Agreement, the Company evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. The Company evaluates factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. Non‑refundable payments that are contingent upon achievement of a substantive milestone are recognized in their entirety in the period in which the milestone is achieved, assuming all other revenue recognition criteria are met. Other contingent payments in which a portion of the milestone consideration is refundable or adjusts based on future performance or non‑performance (e.g., through a penalty or claw‑back provision) are not considered to relate solely to past performance, and therefore, not considered substantive. Amounts that are not recognized as revenue due to the uncertainty as to whether they will be retained or because they are expected to be refunded are recorded as a liability. The Company recognizes non‑substantive milestone payments over the remaining estimated period of performance once the milestone is achieved. Contingent payments associated with the achievement of specific objectives in certain contracts that are not considered substantive because the Company does not contribute effort to the achievement of such milestones are recognized as revenue upon achievement of the objective, as long as there are no undelivered elements remaining and no continuing performance obligations by the Company, assuming all other revenue recognition criteria are met.
Under the Collaboration Agreement, the Company is entitled to receive aggregate payments of up to $28.0 million upon the achievement of specified development and regulatory milestones, and $15.0 million upon the achievement of a commercial milestone. Certain of the milestones related to preparation of an IND for submission to regulatory authorities in the territory are considered substantive given that they are triggered by the Company’s performance relative to the achievement of pre-specified, “at risk” milestone events, such as the initiation or successful completion of regulatory development phases. All other milestones are considered non-substantive because the milestone is dependent upon the performance of the collaboration partner rather than the Company.
On September 1, 2017, the Company entered into a new services agreement with JT Torii to provide research and development services, including regulatory, chemistry and manufacturing support and related materials that is distinct from the original Collaboration Agreement. The Company evaluated the new services agreement and determined that the research and materials delivered to JT Torii represents a separate earnings process that provides stand alone value to JT Torii. The fees received under the services agreement will be recognized as and when such services are performed by the Company and JT Torii consumes the benefits of those services. The Company has no obligation to provide services unless requested by JT Torii and agreed to by us. The Company is eligible to receive reimbursement of estimated costs incurred and payment for research services performed directly by the Company at agreed upon rates. During the quarter ended September 30, 2017, the Company recognized revenue of $0.5 million related to the new services agreement.
The services agreement terminates upon the termination of the Collaboration Agreement or by mutual agreement of the parties.
Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in the Company’s balance sheets. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, current portion. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion.
Net Loss per Share of Common Stock
Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted‑average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted‑average number of common shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, convertible preferred stock and common stock options are considered to be potentially dilutive securities. Because the Company has
reported a net loss for the
nine
months ended
September 30, 2016
and 2017, diluted net loss per common share is the same as basic net loss per common share for those periods.
Unaudited Pro Forma Net Loss per Share Attributable to Common Stockholders
In contemplation of the planned IPO, the unaudited pro forma basic and diluted net loss per share attributable to common stockholders is presented in the statement of operations, which has been computed to give effect to the conversion of the convertible preferred stock into shares of common stock in accordance with conversion features present in the convertible preferred stock as of the beginning of the respective period or the date of issuance, if later. See Note 9,
Net Loss per Share Attributable to Common Stockholders.
Recent Accounting Pronouncements
In November 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2016‑18,
Statement of Cash Flows (Topic 230): Restricted Cash (a consensus of the FASB Emerging Issues Task Force)
. The update requires that the 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. ASU 2016‑18 is effective for public entities for annual periods beginning after December 15, 2017, and interim periods within those annual periods. The Company is currently evaluating the effects, if any, that the adoption of this guidance will have on its financial statements.
In March 2016, the FASB issued ASU 2016‑09,
Improvements to Employee Share‑Based Payment Accounting
as part of its simplification initiative, which involves several aspects of accounting for share‑based payment transactions, including the income tax effects, statutory withholding requirements, forfeitures and classification on the statement of cash flows. The standard is effective for companies for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years with early adoption permitted. The Company adopted this standard as of January 1, 2017, and there was no impact to the Company’s financial statements as a result of the adoption.
In February 2016, the FASB issued ASU 2016‑02,
Leases
(ASC 842), which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both parties to a contract (i.e., lessees and lessors). The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight‑line basis over the term of the lease, respectively. A lessee is also required to record a right‑of‑use asset and a lease liability for all leases with a term of greater than twelve months regardless of their classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases today. ASC 842 supersedes the previous leases standard, ASC 840
Leases
. The standard is effective on January 1, 2019, with early adoption permitted. The Company is currently evaluating the effects, if any, that the adoption of this guidance will have on its financial statements.
In January 2016, the FASB issued ASU 2016‑01,
Recognition and Measurement of Financial Assets and Financial Liabilities,
which addresses certain aspects of recognition, measurement, presentation and disclosure of financial instruments. ASU 2016‑01 is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. The Company is currently evaluating the effects, if any, that the adoption of this guidance will have on its financial statements.
In November 2015, the FASB issued ASU 2015‑17,
Balance Sheet Classification of Deferred Taxes
to simplify the presentation of deferred income taxes. The amendments in this update require that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. We have elected to early adopt ASU 2015‑17 as of the beginning of our fourth quarter ended December 31, 2015 on a prospective basis. There was no impact to the balance sheet amounts as a result of early adoption.
In August 2014, the FASB issued ASU 2014‑15 related to Presentation of Financial Statements ‑
Going Concern (Subtopic 205‑40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern
. This update provides guidance about management’s responsibilities in evaluating an entity’s going concern uncertainties, and about the timing and content of related footnote disclosures. Under this amended guidance, an entity’s management should evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern within one year
after the date that the financial statements are issued. This update is effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early application is permitted. The Company adopted this standard in 2016 and there was no impact on the financial position, results of operations or related financial statement disclosures
In June 2014, the FASB issued ASU 2014‑12,
Accounting for Share‑Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period
. ASU 2014‑12 requires that a performance target that affects vesting and could be achieved after the requisite service period be treated as a performance condition. ASU 2014‑12 is effective for the Company for the annual period ending after December 15, 2015 with early adoption permitted. The adoption of ASU 2014‑12 did not have a material effect on the Company’s financial statements.
In May 2014, the FASB issued ASU No. 2014‑09,
Revenue from Contracts with Customers (Topic 606)
, which supersedes the revenue recognition requirements in ASC 605,
Revenue Recognition
. This ASU is based on the principle that revenue is recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In August 2015, FASB issued ASU No. 2015‑14,
Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date
, which effectively delayed the adoption date by one year, to an effective date for public entities for annual and interim periods beginning after December 15, 2017. In March, April and May 2016, the FASB issued additional updates to the new revenue standard relating to reporting revenue on a gross versus net basis, identifying performance obligations and licensing arrangements, and narrow‑scope improvements and practical expedients, respectively. The effective date of this additional update is the same as that of ASU 2014‑09. The guidance permits the use of either a retrospective or cumulative effect transition method. The Company has not yet selected a transition method. The Company is still finalizing the analysis to quantify the adoption impact of the provisions of the new standard, but it does not currently expect to have a material impact on the financial position or results of operations. Based on the evaluation of its current collaboration agreement and associated revenue streams, most of the revenue will be recorded consistently under both the current and the new standard. The FASB has issued, and may issue in the future, interpretive guidance which may cause the Company’s evaluation to change. The Company believes it is following an appropriate time line to allow for proper recognition, presentation and disclosure upon adoption effective the beginning of fiscal year 2018.
There are no other recently issued accounting standards that apply to the Company or that are expected to have a material impact on results of operations, financial condition, or cash flows.
3. Fair Value Measurements
The fair value of our financial instruments reflects the amounts that we estimate we would receive in connection with the sale of an asset or pay in connection with the transfer of a liability in an orderly transaction between market participants at the measurement date (exit price). We disclose and recognize the fair value of our assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements). The guidance establishes three levels of the fair value hierarchy as follows:
Level 1 ‑ Inputs that reflect unadjusted quoted prices in active markets for identical assets or liabilities that we have the ability to access at the measurement date;
Level 2 ‑ Inputs other than quoted prices that are observable for the assets or liability either directly or indirectly, including inputs in markets that are not considered to be active;
Level 3 ‑ Inputs that are unobservable.
Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. Our assessment of the significance of a particular input to the fair
value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.
During the periods presented, the Company has not changed the manner in which it values assets and liabilities that are measured at fair value using Level 3 inputs. The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no transfers within the hierarchy during the year ended December 31, 2016 and the
nine
months ended
September 30, 2017
.
A summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using
|
|
|
Total
Carrying
Value
|
|
Quoted
Prices
in Active
Markets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
December 31, 2016:
|
|
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
Money market funds
|
|
$
|
3,808
|
|
|
$
|
3,808
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Corporate notes
|
|
26,108
|
|
|
7,225
|
|
|
18,883
|
|
|
—
|
|
Government notes
|
|
11,193
|
|
|
11,193
|
|
|
—
|
|
|
—
|
|
Total assets
|
|
$
|
41,109
|
|
|
$
|
22,226
|
|
|
$
|
18,883
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using
|
|
|
Total
Carrying
Value
|
|
Quoted
Prices
in Active
Markets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
September 30, 2017 (unaudited)
|
|
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
Money market funds
|
|
$
|
7,713
|
|
|
$
|
7,713
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Corporate notes
|
|
54,395
|
|
|
5,118
|
|
|
49,277
|
|
|
—
|
|
Government notes
|
|
9,694
|
|
|
9,694
|
|
|
—
|
|
|
—
|
|
Total assets
|
|
$
|
71,802
|
|
|
$
|
22,525
|
|
|
$
|
49,277
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
The Company uses a market approach for determining the fair value of all its Level 1 and Level 2 money market funds and marketable securities. To value its money market funds, the Company values the funds at
$1
stable net asset value, which is the market pricing convention for identical assets that the Company has the ability to access.
The investments are classified as available‑for‑sale securities. At December 31, 2016 and
September 30, 2017
, the balance in the Company’s accumulated other comprehensive income was comprised solely of activity related to the Company’s available‑for‑sale securities. There were no realized gains or losses recognized on the
sale or maturity of available‑for‑sale securities during the 12 months ended December 31, 2016 and the
nine
months ended
September 30, 2017
and as a result, the Company did not reclassify any amounts out of accumulated other comprehensive income for the same periods. The Company has a limited number of available‑for‑sale securities in insignificant loss positions as of December 31, 2016 and
September 30, 2017
, which the Company does not intend to sell and has concluded it will not be required to sell before recovery of the amortized cost for the investment at maturity.
The following table summarizes the available‑for‑sale securities (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized
Cost
|
|
Unrealized
Gains
|
|
Unrealized
Losses
|
|
Fair Value
|
December 31, 2016:
|
|
|
|
|
|
|
|
|
Money market funds
|
|
$
|
3,808
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,808
|
|
Corporate notes
|
|
26,134
|
|
|
—
|
|
|
(26
|
)
|
|
26,108
|
|
Government notes
|
|
11,193
|
|
|
—
|
|
|
—
|
|
|
11,193
|
|
Total
|
|
$
|
41,135
|
|
|
$
|
—
|
|
|
$
|
(26
|
)
|
|
$
|
41,109
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized
Cost
|
|
Unrealized
Gains
|
|
Unrealized
Losses
|
|
Fair Value
|
September 30, 2017 (unaudited)
|
|
|
|
|
|
|
|
|
Money market funds
|
|
$
|
7,713
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
7,713
|
|
Corporate notes
|
|
54,410
|
|
|
—
|
|
|
(15
|
)
|
|
54,395
|
|
Government notes
|
|
9,694
|
|
|
—
|
|
|
—
|
|
|
9,694
|
|
Total
|
|
$
|
71,817
|
|
|
$
|
—
|
|
|
$
|
(15
|
)
|
|
$
|
71,802
|
|
|
|
|
|
|
|
|
|
|
4. Balance Sheets Components
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2016
|
|
September 30,
2017
|
|
|
|
|
(unaudited)
|
Accrued personnel expenses
|
|
$
|
273
|
|
|
$
|
465
|
|
Accrued clinical and development expenses
|
|
245
|
|
|
1,184
|
|
Other
|
|
63
|
|
|
250
|
|
Total
|
|
$
|
581
|
|
|
$
|
1,899
|
|
|
|
|
|
|
5. Commitments and Contingencies
Legal Matters
The Company’s industry is characterized by frequent claims and litigation, including claims regarding intellectual property. As a result, the Company may be subject to various legal proceedings from time to time. The results of any future litigation cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors. Management is not aware of any pending or threatened litigation.
License Agreement
In December 2012, the Company entered into an exclusive worldwide royalty free license agreement with Merck Sharp & Dohme Corp., or “Merck” for exclusive worldwide rights for the development and commercialization of serlopitant and two other NK
1
‑R antagonists in all human diseases, disorders or conditions, except for the treatment and prevention of nausea or vomiting. The Company paid Merck an upfront non‑refundable non‑creditable licensing fee of
$1.0 million
dollars and issued to Merck shares of its common stock. In addition, the Company has agreed to make aggregate payments of up to
$25.0 million
dollars upon the achievement of specified development and regulatory milestones.
Future milestone payments are considered to be contingent consideration and will be accrued when the applicable milestone is achieved. Through
December 31, 2016
and
September 30, 2017
, no milestones have been achieved under the license agreement.
Leases
The Company conducts its operations using leased office facilities. On April 6, 2016, the Company entered into a lease agreement. The twenty‑six month lease, began on May 1, 2016, and provides 4,000 square feet of office space in Menlo Park, California. Base annual rent was initially approximately
$20,000
per month, with annual increases.
In September 2017, the Company entered into a lease agreement. The thirty‑month lease, beginning on October 1, 2017 provides approximately 14,000 square feet of office space in Redwood City, California. Base annual rent is approximately
$55,000
per month, with annual increases.
The Company recognizes rent expense on a straight‑line basis over the respective lease period. Rent expense for the
nine
months ended
September 30, 2016
and 2017 was
$150,000
and
$175,000
, respectively.
As of
September 30, 2017
, total future minimum lease payments under our operating leases are as follows (unaudited), (in thousands):
|
|
|
|
|
|
|
|
|
Year ending December 31:
|
|
|
2017 (three months remaining)
|
|
$
|
224
|
|
2018
|
|
779
|
|
2019
|
|
675
|
|
2020
|
|
518
|
|
Total future minimum lease payments
|
|
$
|
2,196
|
|
|
|
|
Indemnification
As permitted under Delaware law and in accordance with the Company’s bylaws, the Company is required to indemnify its officers and directors for certain events or occurrences while the officer or director is or was serving in such capacity. The Company is also party to indemnification agreements with its directors. The Company believes the fair value of the indemnification rights and agreements is minimal. Accordingly, the Company has not recorded any liabilities for these indemnification rights and agreements as of December 31,
2016 or
September 30, 2017
.
Contingencies
From time to time, we may have certain contingent liabilities that arise in the ordinary course of our business activities. We accrue a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated.
6. Convertible Preferred Stock
As of
September 30, 2017
, the Company’s Certificate of Incorporation, as amended, authorizes the Company to issue up to 28,322,761 shares of convertible preferred stock, par value of
$0.001
, of which
14,300
are designated Series A convertible preferred stock and
14,106,583
are designated Series B convertible preferred stock, and 14,201,878 shares are designated Series C convertible preferred stock.
From December 2011 through May 2015, the Company issued
14,300
shares of Series A convertible preferred stock to investors at
$1,000
per share with gross proceeds of
$14.3 million
. Purchasers of our Series A convertible preferred stock also received an aggregate of
8.0 million
shares of common stock in connection with the Series A investment.
In November 2015, the Company issued
14,106,583
shares of Series B convertible preferred stock to investors at
$3.19
per share with gross proceeds of
$45.0 million
.
In July 2017, the Company issued
11,854,463
shares of Series C convertible preferred stock to investors at
$4.26
per share with gross proceeds of $50.5 million.
Convertible preferred stock was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2016
|
|
|
Shares Authorized
|
|
Shares Issued and Outstanding
|
|
Aggregate Liquidation Preference
(in thousands)
|
Series A
|
|
14,300
|
|
|
14,300
|
|
|
$
|
14,300
|
|
Series B
|
|
14,106,583
|
|
|
14,106,583
|
|
|
45,000
|
|
Total
|
|
14,120,883
|
|
|
14,120,883
|
|
|
$
|
59,300
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2017 (unaudited)
|
|
|
Shares Authorized
|
|
Shares Issued and Outstanding
|
|
Aggregate Liquidation Preference
(in thousands)
|
Series A
|
|
14,300
|
|
|
14,300
|
|
|
$
|
14,300
|
|
Series B
|
|
14,106,583
|
|
|
14,106,583
|
|
|
45,000
|
|
Series C
|
|
14,201,878
|
|
|
11,854,463
|
|
|
50,500
|
|
Total
|
|
28,322,761
|
|
|
25,975,346
|
|
|
$
|
109,800
|
|
|
|
|
|
|
|
|
Significant terms of the Series A, B and C convertible preferred stock as of
September 30, 2017
(unaudited)(collectively, the “Preferred Stock”) are as follows:
Liquidation Preference
In the event of any liquidation, dissolution, or winding up of the Company, either voluntary or involuntary, the holders of the then outstanding shares of Series A convertible stock, Series B convertible stock and Series C convertible preferred stock are first entitled to receive the amount of
$1,000.00
,
$3.19
and $4.26 per share, respectively plus all declared but unpaid dividends for such shares, prior and in preference to any distribution of any assets of the Company to the holders of the common stock. If, upon the occurrence of such event, the proceeds distributed among the holders of the Series A, B and C convertible preferred stock are insufficient to permit the full payment of the aforesaid preferential amounts to each holder of convertible preferred stock, then the entire proceeds legally available for distribution to the convertible preferred stock shall be distributed ratably among the holders of the Series A, B and C convertible preferred stock, as the case may be, in proportion to the full preferential amount that each such holder of the Series is otherwise entitled to receive.
Upon completion of the distributions required by the above‑mentioned liquidation preferences, any remaining proceeds shall be distributed among the holders of Series B and C convertible preferred stock and common stock pro rata based on the number of shares of common stock held by each, assuming full conversion of the Series B and C convertible preferred stock to common stock at the then-effective conversion price for such shares.
Dividends
The holders of shares of Series A, B and C convertible preferred stock are entitled to receive non-cumulative dividends, out of any assets legally available, prior and in preference to any declaration or payment of any dividend on the common stock, at the applicable dividend rate of
$80.00
per annum for each share of Series A convertible preferred stock,
$0.2552
per annum for each share of Series B convertible preferred stock and $0.3408 per share per annum for each share of Series C convertible preferred stock, all subject to adjustment from time to time for recapitalizations, payable when and if declared by the Company’s board of directors. The Company has never declared any dividends on its convertible preferred stock.
Voting
The holder of each share of Series B and C convertible preferred stock are entitled to one vote for each share of common stock into which such preferred stock could then be converted and, with respect to such vote, such holder has full voting rights and powers equal to the voting rights and powers of the holders of common stock and is entitled to notice of any stockholders’ meeting in accordance with the Company’s bylaws. The holders of shares of Series A convertible preferred stock do not have a right to vote, other than as required by Delaware law and for certain directors, as set forth below.
The holders of shares of Series A convertible preferred stock are entitled to elect two of the Company’s directors. The holders of Series B convertible preferred stock are entitled to elect two of the Company’s directors. The holders of Series C convertible preferred stock are entitled to elect one of the Company’s directors. The holders of outstanding common stock are entitled to elect three of the Company’s directors. The holders of convertible preferred stock and common stock, voting together as a single class, and not as separate series, and on an as converted basis, are entitled to elect any remaining directors of the Company, subject to the approval of the then serving members of the Company’s directors.
Conversion
The holder of each share of convertible preferred stock has the option to convert each share of convertible preferred stock into such number of fully paid and nonassessable shares of common stock as is determined by dividing the applicable original issue price for such series by the applicable conversion price for such series in effect on the date the certificate is surrendered for conversion. Each share of convertible preferred stock shall automatically be converted into shares of common stock at the conversion rate at the time in effect for such series of convertible preferred stock immediately prior to the earlier of (i) sale of the Company’s common stock in a firm commitment underwritten public offering pursuant to a registration statement under the Securities Act of 1933, as amended, with gross proceeds of not less than
$40.0 million
in the aggregate and an offering price to the public of no less than
$6.38
per share, or (ii) upon the receipt by the Corporation of a written request or agreement of the holders of a majority of the outstanding Series A, B and C convertible preferred stock, voting together as a single class and on an as converted basis.
The conversion price of the convertible preferred stock was initially set at an amount equal to the issue price. The Series B and C convertible preferred stock conversion price is subject to adjustment for stock dividends, stock splits, re-capitalization and upon the occurrence of certain triggering events related to anti-dilution protection rights. In the event that a future preferred stock financing should occur at a price lower than the last preferred financing round, the conversion ratios of the existing preferred stock are changed to protect the ownership position of existing investors.
7. Common Stock
The Company’s Certificate of Incorporation, as amended, authorizes the Company to issue 55,000,000 shares of
$0.0001
par value common stock. Each share of common stock is entitled to one vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when and if declared by the board of directors, subject to the prior rights of holders of all classes of preferred stock outstanding. The Company has never declared any dividends on common stock.
Shares of common stock reserved for issuance are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2016
|
|
September 30,
2017
|
|
|
|
|
(unaudited)
|
Conversion of Series A convertible preferred stock
|
|
14,300
|
|
|
14,300
|
|
Conversion of Series B convertible preferred stock
|
|
14,106,583
|
|
|
14,106,583
|
|
Conversion of Series C convertible preferred stock
|
|
—
|
|
|
11,854,463
|
|
Total conversion of preferred stock
|
|
14,120,883
|
|
|
25,975,346
|
|
Options outstanding
|
|
4,006,198
|
|
|
5,807,569
|
|
Options available for future grant under stock option plan
|
|
536,677
|
|
|
665,606
|
|
Total
|
|
18,663,758
|
|
|
32,448,521
|
|
|
|
|
|
|
8. Stock-Based Compensation
Under the Company’s 2011 Stock Incentive Plan (the “2011 Plan”), the Company may grant options to purchase common stock, restricted stock awards, or directly issue shares of common stock to employees, directors and consultants of the Company. During 2015, the Company’s board of directors and stockholders approved an increase to the shares available under the 2011 Plan to
5,628,605
shares. During the
nine
-month period ended
September 30, 2017
, the Company’s board of directors and stockholders approved an increase to the shares available under the 2011 Plan to
7,608,905
shares. Options may be granted at an exercise price per share of not less than 100% of the fair market value at the date of grant. If an incentive stock option is granted to a stockholder holding 10% of the Company’s outstanding capitalization, then the purchase or exercise price per share must not be less than 110% of the fair market value per share of common stock on the grant date. Options granted are exercisable over a maximum term of
10 years
from the date of grant and generally vest over a period of four years.
Total stock-based compensation expense for employees and non-employees recognized in the statements of operations was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
|
2016
|
|
2017
|
|
|
(unaudited)
|
Research and development
|
|
$
|
127
|
|
|
$
|
676
|
|
General and administrative
|
|
184
|
|
|
541
|
|
Total stock-based compensation expense
|
|
$
|
311
|
|
|
$
|
1,217
|
|
|
|
|
|
|
At
September 30, 2017
, there was approximately
$4.4 million
of unamortized compensation expense, which was expected to be recognized over a weighted average period of
2.8 years
.
2011 Plan
The table below summarizes stock option and restricted award activity under the 2011 Plan:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Shares Available for Issuance
|
|
Number of Shares Outstanding
|
|
Weighted-Average Exercise Price
|
|
Weighted- Average Remaining Contractual Term (Years)
|
|
Aggregate Intrinsic Value (in thousands)
|
Balances at December 31, 2016
|
|
536,677
|
|
|
4,006,198
|
|
|
$
|
0.74
|
|
|
9.32
|
|
|
$
|
3,805
|
|
Authorized (unaudited)
|
|
1,980,300
|
|
|
—
|
|
|
|
|
|
|
|
Exercised (unaudited)
|
|
—
|
|
|
(50,000
|
)
|
|
$
|
0.68
|
|
|
|
|
|
Granted (unaudited)
|
|
(1,851,371
|
)
|
|
1,851,371
|
|
|
$
|
1.77
|
|
|
|
|
|
Balances at September 30, 2017 (unaudited)
|
|
665,606
|
|
|
5,807,569
|
|
|
$
|
1.07
|
|
|
8.90
|
|
|
$
|
8,886
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional information regarding options outstanding at
September 30, 2017
was as follows (unaudited):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding
|
|
Options Vested
|
Exercise Price
|
|
Number of
Shares
|
|
Weighted-
Average
Remaining
Contractual
Life (Years)
|
|
Weighted-
Average
Exercise
Price
|
|
Number of
Shares
|
|
Weighted-
Average
Exercise
Price
|
$0.68
|
|
3,579,818
|
|
|
8.38
|
|
|
$
|
0.68
|
|
|
1,525,952
|
|
|
$
|
0.68
|
|
$1.32
|
|
376,380
|
|
|
9.18
|
|
|
$
|
1.32
|
|
|
24,241
|
|
|
$
|
1.32
|
|
$1.69
|
|
297,720
|
|
|
9.42
|
|
|
$
|
1.69
|
|
|
1,166
|
|
|
$
|
1.69
|
|
$1.79
|
|
1,553,651
|
|
|
9.92
|
|
|
$
|
1.79
|
|
|
13,014
|
|
|
$
|
1.79
|
|
$0.68 - $1.79
|
|
5,807,569
|
|
|
8.90
|
|
|
$
|
1.07
|
|
|
1,564,373
|
|
|
$
|
0.70
|
|
|
|
|
|
|
|
|
|
|
|
|
Upon vesting of restricted shares and exercise of options, the Company issues common stock from its authorized shares. During the
nine
months ended
September 30, 2016
and 2017, there were zero and 50,000 options exercised, respectively. The intrinsic value of the options exercised during the nine months ended September 30, 2017 was $56,000. There were
599,053
and 432,266 shares of early exercised restricted shares which have not vested at
December 31, 2016
and
September 30, 2017
, respectively. As of
December 31, 2016
and
September 30, 2017
, the Company had recorded a liability of
$68,000
and $49,000, respectively for the early exercise of stock options, recorded as other current liabilities and other non-current liabilities. When options are subject to the Company’s repurchase right, the Company may buy back any unvested shares at their original exercise price in the event of an employee’s termination prior to full vesting.
The aggregate fair value of employee options vesting during the
nine
months ended
September 30, 2016
and
2017
was approximately $124,000 and $727,000, respectively.
Stock Awards Granted to Employees and Directors
Stock-based compensation expense is based on the grant date fair value. The Company recognizes compensation expense for all stock-based options and restricted awards on a straight-line basis over the requisite service period of the awards, which is generally the option vesting term of four years. Stock-based compensation expense related to awards granted to employees and directors for the
nine
months ended
September 30, 2016
and
2017
was approximately $231,000 and $429,000, respectively.
The Company uses the Black-Scholes option valuation model, which requires the use of highly subjective assumptions to determine the fair value of stock-based awards. The assumptions used in the Company’s option-pricing model represent management’s best estimates. These estimates are complex, involve a number of variables, uncertainties and assumptions and the application of management’s judgment. If factors change and different assumptions are used, the Company’s stock-based compensation expense could be materially different in the future. The assumptions and estimates that the Company uses in the Black-Scholes model are as follows:
|
|
▪
|
Fair Value of Common Stock
. The estimated fair value of the common stock underlying the Company’s stock options was determined at each grant date by our board of directors, with input from management. All options to purchase shares of our common stock are intended to be exercisable at a price per share not less than the per-share fair value of the Company’s common stock underlying those options on the date of grant. In the absence of a public trading market for our common stock, on each grant date, we develop an estimate of the fair value of our common stock based on the information known to the Company on the date of grant, upon a review of any recent events and their potential impact on the estimated fair value per share of the common stock and in part on input from an independent third-party valuation.
|
|
|
▪
|
Risk-Free Interest Rate
. The Company bases the risk-free interest rate used in the Black-Scholes valuation model on the implied yield available on U.S. Treasury zero-coupon issues with a term equivalent to that of the expected term of the options for each option group.
|
|
|
▪
|
Expected Term
. The expected term represents the period that the Company’s stock-based awards are expected to be outstanding. Because of the limitations on the sale or transfer of the Company’s common stock as a privately held company, the Company does not believe its historical exercise pattern is indicative of the pattern it will experience as a publicly traded company. The Company has consequently used the Staff Accounting Bulletin 110, or SAB 110, simplified method to calculate the expected term, which is the average of the contractual term and vesting period. The Company plans to continue to use the SAB 110 simplified method until it has sufficient trading history as a publicly traded company.
|
|
|
▪
|
Volatility
. The Company determines the price volatility based on the historical volatilities of industry peers as it has no trading history for its common stock price. Industry peers consist of several public companies in the biotechnology industry with comparable characteristics, including clinical trials progress and therapeutic indications.
|
|
|
▪
|
Dividend Yield
. The expected dividend assumption is based on the Company’s current expectations about its anticipated dividend policy. To date, the Company has not declared any dividends, and therefore the Company has used an expected dividend yield of zero.
|
In addition to the assumptions used in the Black-Scholes valuation model, the Company must also estimate a forfeiture rate to calculate the stock-based compensation for its equity awards. The Company will continue to use judgment in evaluating the assumptions related to the Company’s stock-based compensation on a prospective basis. As the Company continues to accumulate additional data, it may have refinements to its estimates, which could materially impact the Company’s future stock-based compensation expense.
The following assumptions were used to calculate the fair value of awards granted to employees and directors during the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
|
2016
|
|
2017
|
|
|
(unaudited)
|
Expected term (in years)
|
|
4.6 - 6.1
|
|
6.0 - 6.1
|
Volatility
|
|
68% - 71%
|
|
75% - 100%
|
Risk-free interest rate
|
|
1.3% - 1.5%
|
|
1.9% - 2.2%
|
Dividend yield
|
|
—
|
|
—
|
|
|
|
|
|
Stock-Based Compensation for Non-employees
Stock-based compensation expense related to stock awards granted to non-employees is recognized as the awards vest. The Company believes that the fair value of the stock-based awards granted is more reliably measurable than the fair value of the services received. The fair value of stock awards granted is calculated using the Black-Scholes option valuation model. Stock-based compensation expense related to awards granted to non-employees for the
nine
months ended
September 30, 2016
and
2017
was approximately $80,000 and $788,000, respectively.
The fair values of common stock awards granted to non-employees were calculated using the following assumptions for the periods presented:
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
|
2016
|
|
2017
|
|
|
(unaudited)
|
Expected term (in years)
|
|
9.5 - 9.8
|
|
8.5 - 10.0
|
Volatility
|
|
84% - 86%
|
|
74% - 100%
|
Risk-free interest rate
|
|
1.6%
|
|
2.1% - 2.5%
|
Dividend yield
|
|
—
|
|
—
|
|
|
|
|
|
9. Net Loss per Share Attributable to Common Stockholders
The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders (in thousands, except share and per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
|
2016
|
|
2017
|
|
|
(unaudited)
|
Numerator:
|
|
|
|
|
Net loss attributable to common stockholders, basic and diluted
|
|
$
|
(9,231
|
)
|
|
$
|
(19,800
|
)
|
Denominator:
|
|
|
|
|
Weighted-average common shares outstanding
|
|
14,242,980
|
|
|
14,245,910
|
|
Less: weighted-average common shares subject to repurchase
|
|
(872,171
|
)
|
|
(524,925
|
)
|
Weighted-average common shares used to compute basic and diluted net loss per share
|
|
13,370,809
|
|
|
13,720,985
|
|
Net loss per share attributable to common stockholders
|
|
|
|
|
Basic and diluted
|
|
$
|
(0.69
|
)
|
|
$
|
(1.44
|
)
|
|
|
|
|
|
The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
2016
|
|
2017
|
|
|
(unaudited)
|
Convertible preferred stock
|
|
14,120,883
|
|
|
25,975,346
|
|
Outstanding common stock subject to repurchase
|
|
654,649
|
|
|
432,266
|
|
Stock options outstanding
|
|
3,629,818
|
|
|
5,807,569
|
|
Stock options available for issuance
|
|
913,057
|
|
|
665,606
|
|
Total
|
|
19,318,407
|
|
|
32,880,787
|
|
|
|
|
|
|
Unaudited Pro Forma Basic and Diluted Loss Per Share
The unaudited pro forma basic and diluted loss per share for the
nine
months ended
September 30, 2017
give effect to the conversion of all shares of convertible preferred stock upon the closing of the planned IPO by treating all shares of convertible preferred stock as if they had been converted to common stock at the beginning of the earliest period presented, or the date of the original issuance, if later. Shares to be sold in the planned IPO are excluded from the unaudited pro forma basic and diluted loss per share calculations.
Unaudited pro forma basic and diluted net loss per share attributable to common stockholders are computed as follows (in thousands, except share and per share data):
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2017
|
|
|
(unaudited)
|
Pro forma loss per share - basic and diluted
|
|
|
Numerator
|
|
|
Net loss attributable to common stockholders, basic and diluted
|
|
$
|
(19,800
|
)
|
Denominator
|
|
|
Weighted-average common shares outstanding, basic and diluted
|
|
13,720,985
|
|
Adjustment for assumed effect of conversion of convertible preferred stock
|
|
17,387,492
|
|
Pro forma weighted-average number of shares outstanding - basic and diluted net loss per share
|
|
31,108,477
|
|
Pro forma net loss per share attributable to common stockholders
|
|
|
Basic and diluted
|
|
$
|
(0.64
|
)
|
|
|
|
10. Related Party Transactions
From 2011 through
December 31, 2016
, the Company has operated with significant consulting and management services provided by Velocity Pharmaceutical Development, LLC (“VPD”). The Development Services Agreement with VPD ended on
December 31, 2016
. Development services fees paid to VPD under the Development Services Agreement were $0.8 million and
$0
for the
nine
months ended
September 30, 2016
and 2017, respectively. The Company also reimbursed VPD for consulting, travel and other expenses incurred on our behalf. As of
December 31, 2016
and
September 30, 2017
, the Company had no outstanding liabilities to VPD. Several managing directors of VPD have served as officers and directors of the Company. David Collier, M.D., a former member of the Company’s board of directors, is the Chief Executive Officer of VPD, and Xiaoming Zhang, Ph.D., our Senior Vice President, Non-Clinical and Pharmaceutical Development, is a Venture Partner of VPD.
The Company has entered into a services agreement with Theratrophix, which is partially owned by Dr. Zhang. During the
nine
months ended
September 30, 2016
and 2017, the Company incurred expenses of $247,000 and $105,000, respectively with Theratrophix. As of
September 30, 2017
, there was no outstanding accounts payable balance owed to Theratrophix.
11. Subsequent Events
In November 2017, the Company recognized $2.0 million of revenue upon achievement of a contingent milestone under the JT Torii Collaboration and License Agreement.
The Company has reviewed and evaluated subsequent events that occurred through December 28, 2017, the date the financial statements were available to be issued, and determined that no additional subsequent events had occurred that would require recognition or disclosure in these financial statements.
Shares
Common Stock
|
|
|
|
|
|
Joint Book-Running Managers
|
|
|
|
|
|
Jefferies
|
|
Piper Jaffray
|
|
Guggenheim Securities
|
|
|
|
|
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Lead Manager
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JMP Securities
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, 2018
PART II
Information Not Required in Prospectus
Item 13. Other Expenses of Issuance and Distribution.
The following table sets forth the costs and expenses, other than the underwriting discounts and commissions, payable by the registrant in connection with the sale of Common Stock being registered. All amounts are estimates except for the Securities and Exchange Commission, or SEC, registration fee, the FINRA filing fee and the Nasdaq Global Market listing fee.
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Item
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Amount to be paid
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SEC registration fee
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$12,170
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FINRA filing fee
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$15,163
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Nasdaq Global Market Listing fee
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*
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Printing and engraving expenses
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*
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Legal fees and expenses
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*
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Accounting fees and expenses
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*
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Blue Sky, qualification fee and expenses
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*
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Transfer Agent fees and expenses
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*
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Miscellaneous expenses
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*
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Total
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$ *
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*
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To be completed by amendment.
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Item 14. Indemnification of Directors and Officers.
As permitted by Section 102 of the Delaware General Corporation Law, our amended and restated certificate of incorporation and bylaws to be in effect immediately prior to the completion of this offering limit or eliminate the personal liability of each of our directors for a breach of his or her fiduciary duty of care as a director. The duty of care generally requires that, when acting on behalf of the corporation, directors exercise an informed business judgment based on all material information reasonably available to them. Consequently, a director will not be personally liable to us or our stockholders for monetary damages for breach of fiduciary duty as a director, except for liability for:
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▪
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any breach of the director’s duty of loyalty to us or our stockholders;
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▪
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any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;
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▪
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any act related to unlawful stock repurchases, redemptions or other distributions or payment of dividends; or
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▪
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any transaction from which the director derived an improper personal benefit.
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These limitations of liability do not affect the availability of equitable remedies such as injunctive relief or rescission. Our amended and restated certificate of incorporation also authorizes us to indemnify our officers, directors and other agents to the fullest extent permitted under Delaware law.
As permitted by Section 145 of the Delaware General Corporation Law, our amended and restated bylaws to be in effect immediately prior to the completion of this offering provide that:
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▪
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we shall indemnify our directors and officers, and may indemnify our employees or agents to the fullest extent permitted by the Delaware General Corporation Law, subject to limited exceptions;
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▪
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we shall advance expenses to our directors and officers, and may advance expenses to our employees and agents in connection with a legal proceeding to the fullest extent permitted by the Delaware General Corporation Law, subject to limited exceptions; and
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▪
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the rights provided in our amended and restated bylaws are not exclusive.
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Our amended and restated certificate of incorporation, to be attached as Exhibit 3.2 hereto, and our amended and restated bylaws, to be attached as Exhibit 3.4 hereto, provide for the indemnification provisions described above and elsewhere herein. We have entered into separate indemnification agreements with our directors and officers which may be broader than the specific indemnification provisions contained in the Delaware General Corporation Law. These indemnification agreements generally require us, among other things, to indemnify our officers and directors against liabilities that may arise by reason of their status or service as directors or officers, other than liabilities arising from unlawful conduct. These indemnification agreements also generally require us to advance any expenses incurred by the directors or officers as a result of any proceeding against them as to which they could be indemnified. In addition, we have purchased a policy of directors’ and officers’ liability insurance that insures our directors and officers against the cost of defense, settlement or payment of a judgment in some circumstances. These indemnification provisions and the indemnification agreements may be sufficiently broad to permit indemnification of our officers and directors for liabilities, including reimbursement of expenses incurred, arising under the Securities Act of 1933, as amended, or the Securities Act.
The form of Underwriting Agreement, to be attached as Exhibit 1.1 hereto, provides for indemnification by the underwriters of us and our officers who sign this Registration Statement and directors for specified liabilities, including matters arising under the Securities Act.
Item 15. Recent Sales of Unregistered Securities.
The following list sets forth information as to all securities we have sold since January 1, 2014, which were not registered under the Securities Act.
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1.
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In November 2015, we issued an aggregate of 14,106,583 shares of our Series B Preferred Stock at a price per share of $3.19 in cash.
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2.
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In July 2017, we issued an aggregate of 11,854,463 shares of our Series C convertible preferred stock at a price per share of $4.26 in cash.
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3.
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We sold an aggregate of 939,530 shares of common stock to employees and directors for cash and other consideration in the aggregate amount of approximately $136,496 upon the exercise of stock options and stock awards.
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4.
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We granted stock options and stock awards to employees, directors and consultants covering an aggregate of 7,740,139 shares of common stock, at a weighted-average exercise price of $1.15 per share.
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We claimed exemption from registration under the Securities Act for the sale and issuance of securities in the transactions described in paragraphs (1) and (2) by virtue of Section 4(a)(2) and/or Regulation D promulgated thereunder as transactions not involving any public offering. All of the purchasers of unregistered securities for which we relied on Section 4(a)(2) and/or Regulation D represented that they were accredited investors as defined under the Securities Act. We claimed such exemption on the basis that (a) the purchasers in each case represented that they intended to acquire the securities for investment only and not with a view to the distribution thereof and that they either received adequate information about the registrant or had access, through employment or other relationships, to such information and (b) appropriate legends were affixed to the stock certificates issued in such transactions.
We claimed exemption from registration under the Securities Act for the sales and issuances of securities in the transactions described in paragraphs (3) and (4) above under Section 4(a)(2) of the Securities Act in that such sales and issuances did not involve a public offering or under Rule 701 promulgated under the Securities Act, in that they were offered and sold either pursuant to written compensatory plans or pursuant to a written contract relating to compensation, as provided by Rule 701.
Item 16. Exhibits and Financial Statement Schedules.
(a) Exhibits.
See the Exhibit Index attached to this Registration Statement, which is incorporated by reference herein.
(b) Financial Statement Schedules.
Schedules not listed above have been omitted because the information required to be set forth therein is not applicable or is shown in the financial statements or notes thereto.
Item 17. Undertakings.
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 SEC 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 of 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.
The undersigned Registrant hereby undertakes that:
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1.
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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 upon 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 part of this Registration Statement as of the time it was declared effective.
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2.
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For the purpose 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.
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The undersigned Registrant hereby undertakes to provide to the underwriters at the closing specified in the underwriting agreement certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.
Exhibit Index
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Exhibit
Number
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Exhibit Description
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1.1*
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Form of Underwriting Agreement.
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3.1
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3.2*
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Form of Certificate of Amendment to Amended and Restated Certificate of Incorporation, effecting a stock split.
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3.3
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3.4
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3.5
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4.1
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Reference is made to exhibits 3.1 through 3.5.
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4.2*
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Form of Common Stock Certificate.
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4.3
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5.1*
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Opinion of Morrison & Foerster LLP.
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10.1†
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10.2†
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10.3
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10.4(a)#
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10.4(b)#
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10.4(c)#
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10.4(d)#
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10.5(a)#*
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2018 Omnibus Incentive Plan.
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10.5(b)#*
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Form of Stock Option Grant Notice and Stock Option Agreement under the 2018 Equity Incentive Plan.
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10.6#*
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2018 Employee Stock Purchase Plan.
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10.7#
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10.8#
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10.9#
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10.10#
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10.11#
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10.12#
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23.1
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23.3*
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Consent of Morrison & Foerster LLP (included in Exhibit 5.1).
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24.1
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*
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To be filed by amendment.
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†
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Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment and this exhibit will be filed separately with the SEC.
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#
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Indicates management contract or compensatory plan.
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Signatures
Pursuant to the requirements of the Securities Act of 1933, as amended, the Registrant has duly caused this Registration Statement on Form S-1 to be signed on its behalf by the undersigned, thereunto duly authorized, in Redwood City, California on the 28th day of December, 2017.
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Menlo Therapeutics Inc.
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By:
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/s/ Steven Basta
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Steven Basta
President and Chief Executive Officer
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Power of Attorney
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Steven Basta and Kristine Ball, and each of them acting individually, as his or her true and lawful attorneys-in-fact and agents, each with full power of substitution, for him or her in any and all capacities, to sign any and all amendments to this Registration Statement, including post-effective amendments or any abbreviated registration statement and any amendments thereto filed pursuant to Rule 462(b) increasing the number of securities for which registration is sought, and to file the same, with all exhibits thereto and other documents in connection therewith, with the SEC, granting unto said attorneys-in-fact and agents, with full power of each to act alone, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully for all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or his or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act, this Registration Statement has been signed by the following persons in the capacities and on the dates indicated.
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Signature
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Title
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Date
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/s/ Steven Basta
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President, Chief Executive Officer and Director
(Principal Executive Officer)
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December 28, 2017
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Steven Basta
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/s/ Kristine Ball
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Senior Vice President, Corporate Strategy and Chief Financial Officer
(Principal Financial and Accounting Officer)
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December 28, 2017
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Kristine Ball
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/s/ Paul Berns
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Director
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December 28, 2017
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Paul Berns
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/s/ Albert Cha, M.D., Ph.D.
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Director
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December 28, 2017
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Albert Cha, M.D., Ph.D.
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/s/ Ted Ebel
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Director
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December 28, 2017
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Ted Ebel
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/s/ David McGirr
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Director
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December 28, 2017
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David McGirr
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/s/ Aaron Royston, M.D.
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Director
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December 28, 2017
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Aaron Royston, M.D.
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/s/ Scott Whitcup, M.D.
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Director
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December 28, 2017
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Scott Whitcup, M.D.
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AMENDED AND RESTATED CERTIFICATE OF INCORPORATION
OF
MENLO THERAPEUTICS INC.
Menlo Therapeutics Inc., a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “
Corporation
”),
DOES HEREBY CERTIFY:
FIRST: That the name of the Corporation is Menlo Therapeutics Inc.
SECOND: That the Corporation’s original Certificate of Incorporation was filed with the Secretary of State of the State of Delaware on October 21, 2011. The Corporation was originally incorporated under the name of Tigercat Pharma, Inc.
THIRD: That the Board of Directors of the Corporation has duly adopted resolutions proposing to amend and restate the Certificate of Incorporation, and that said amendment and restatement was duly adopted in accordance with the provisions of Sections 242 and 245 of the General Corporation Law of the State of Delaware and that said amendment and restatement was approved by the holders of the requisite number of shares of this Corporation in accordance with Section 228 of the General Corporation Law of the State of Delaware. This Amended and Restated Certificate of Incorporation amends and restates the provisions of the Certificate of Incorporation of the Corporation.
FOURTH: That the text of the Amended and Restated Certificate of Incorporation is hereby restated and further amended to read in its entirety as set forth in
Exhibit A
attached hereto.
IN WITNESS WHEREOF, the Corporation has caused this Amended and Restated Certificate of Incorporation to be signed by its duly authorized officer, this 12th day of July, 2017.
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MENLO THERAPEUTICS INC.
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By:
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/s/ Steven L. Basta
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Steven L. Basta, President
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EXHIBIT A
AMENDED AND RESTATED CERTIFICATE OF INCORPORATION
OF
MENLO THERAPEUTICS INC.
Article I.
The name of this corporation is Menlo Therapeutics Inc. (the “
Corporation
”).
Article II.
The registered office of the Corporation is located at 1209 Orange Street, Wilmington, Delaware, 19801, New Castle County. The name of its registered agent at that address is The Corporation Trust Company.
Article III.
The purpose of the Corporation 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 “
General Corporation Law
”).
Article IV.
A.
Classes of Stock
. This Corporation is authorized to issue two classes of stock to be designated, respectively, “Common Stock” and “Preferred Stock.” The total number of shares that this Corporation is authorized to issue is 83,322,761 shares. 55,000,000 shares shall be Common Stock, each with a par value of $0.0001 per share and 28,322,761 shares shall be Preferred Stock, each with a par value of $0.001 per share.
B.
Rights, Preferences and Restrictions of Preferred Stock
. The Preferred Stock authorized by this Amended and Restated Certificate of Incorporation may be issued from time to time in one or more series. The rights, preferences, privileges, and restrictions granted to and imposed on the Series A Preferred Stock, which series shall consist of 14,300 shares (the “
Series A Preferred Stock
”), the Series B Preferred Stock, which series shall consist of 14,106,583 shares (the “
Series B Preferred Stock
”) and the Series C Preferred Stock, which series shall consist of 14,201,878 shares (the “
Series C Preferred Stock
” and together with the Series A Preferred Stock and the Series B Preferred Stock, the “
Preferred Stock
”), are as set forth below in this Article IV.A.
1.
Dividend Provisions
.
(a)
The holders of shares of Series A Preferred Stock, Series B Preferred Stock and Series C Preferred Stock, on a pari passu basis, shall be entitled to receive
dividends, out of any assets legally available therefor, prior and in preference to any declaration or payment of any dividend (payable other than in Common Stock or other securities and rights convertible into or entitling the holder thereof to receive, directly or indirectly, additional shares of Common Stock of this Corporation) on the Common Stock of this Corporation, at the rate of $80.00 per share per annum for the Series A Preferred Stock (as adjusted for any stock splits, stock dividends, combinations, recapitalizations or the like (collectively, “
Recapitalizations
”)), $0.2552 per share per annum for the Series B Preferred Stock (as adjusted for any Recapitalizations) and $0.3408 per share per annum for the Series C Preferred Stock (as adjusted for any Recapitalizations), payable when, as, and if declared by the Board of Directors. Such dividends shall not be cumulative. Any partial payment shall be made ratably among the holders of Series A Preferred Stock, Series B Preferred Stock and Series C Preferred Stock in proportion to the payment each such holder would receive if the full amount of such dividends were paid.
(b)
After payment of the full amount of any dividends pursuant to Article IV.B.1(a), any additional dividends shall be distributed among all holders of Common Stock.
(c)
As authorized by Section 500 of the California Corporations Code, if Section 500 of the California Corporations Code is applicable to a distribution made by this Corporation, then
distributions can be made without regard to any preferential rights amount or preferential dividends arrears amount under Section 500 of the
California Corporations Code
(and each such amount shall be deemed to be zero for purposes of Section 500).
2.
Liquidation Preference
.
(a)
In the event of any liquidation, dissolution or winding up of this Corporation either voluntary or involuntary (such events and the events specified in Article IV.B.2(c)), each, a “
Liquidation Event
”), the holders of Series A Preferred Stock, Series B Preferred Stock and Series C Preferred Stock shall be entitled to receive, prior and in preference to any distribution of any of the assets of this Corporation to the holders of Common Stock by reason of their ownership thereof, (i) for the Series A Preferred Stock, an amount per share equal to the sum of (A) $1,000 (the “
Original Series A Issue Price
”) for each outstanding share of Series A Preferred Stock and (B) an amount equal to all declared but unpaid dividends on such share, in each case subject to adjustment for Recapitalizations, (ii) for the Series B Preferred Stock, an amount per share equal to the sum of (A) $3.19 (the “
Original Series B Issue Price
”) for each outstanding share of Series B Preferred Stock and (B) an amount equal to all declared but unpaid dividends on such share, in each case subject to adjustment for Recapitalizations and (iii) for the Series C Preferred Stock, an amount per share equal to the sum of (A) $4.26 (the “
Original Series C Issue Price
” and together with the Original Series A Issue Price and the Original Series B Issue Price, the “
Original Issue Prices
”) for each outstanding share of Series C Preferred Stock and (B) an amount equal to all declared but unpaid dividends on such share, in each case subject to adjustment for Recapitalizations. If upon the occurrence of such event, the assets and funds thus distributed among the holders of the Series A Preferred Stock, Series B Preferred Stock and Series C Preferred Stock shall be insufficient to permit the payment to such holders of the full aforesaid preferential amounts, then the entire assets and funds of this Corporation
legally available for distribution to stockholders shall be distributed ratably among the holders of the Series A Preferred Stock, Series B Preferred Stock and Series C Preferred Stock in proportion to the full preferential amount each such holder is otherwise entitled to receive under this Article IV.B.2(a).
(b)
In the event of a Liquidation Event, following completion of the distribution required by paragraph (a) of this Article IV.B.2, if assets or surplus funds remain in the Corporation, the holders of the shares of Series B Preferred Stock, Series C Preferred Stock and Common Stock shall share ratably in all remaining assets and surplus funds of the Corporation, based on the number of shares of Common Stock held by each (treating the shares of Series B Preferred Stock and Series C Preferred Stock for this purpose as if they had been converted to shares of Common Stock at the then-effective Conversion Price (as defined below) for such shares).
(c)
For purposes of this Article IV.B.2, the occurrence of any of the following events (each, a “
Sale of the Company
”) shall be deemed to be a Liquidation Event, unless the holders of at least a majority of the aggregate voting power of the Series B Preferred Stock then outstanding and Series C Preferred Stock then outstanding and the Common Stock held by holders of Series A Preferred Stock, voting together as a single class with the Series B Preferred Stock and Series C Preferred Stock voting on an as-converted basis (the “
Requisite Majority
”) shall determine otherwise:
(i)
any consolidation or merger of the Corporation with or into any other corporation or other entity or person, or any other corporate reorganization, in which either (A) the outstanding shares of capital stock are exchanged for other securities or consideration and the stockholders of the Corporation immediately prior to such event hold less than 50% of the voting securities of the Corporation (or other surviving entity) immediately after such event or (B) the Corporation shall not be the continuing or surviving entity of such consolidation, merger or reorganization, in each case other than a transaction in which the Corporation becomes a direct or indirect wholly-owned subsidiary of a holding company having the same stockholders (with the same relative amounts and type of securities) as the Corporation immediately prior to such transaction;
(ii)
any transaction or series of related transactions occurring after the date upon which any shares of Series C Preferred Stock were first issued as a result of which securities representing in excess of 50% of the Corporation’ s voting power are transferred, other than a transaction in which the Corporation becomes a direct or indirect wholly-owned subsidiary of a holding company having the same stockholders (with the same relative amounts and type of securities) as the Corporation immediately prior to such transaction; or
(iii)
any sale, lease, transfer or exclusive license (including, without limitation, by merger, consolidation or reorganization) in any transaction or series of related transactions of all or substantially all of the assets of the Corporation and its subsidiaries taken as a whole, other than a transaction in which the Corporation becomes a direct or indirect
wholly-owned subsidiary of a holding company having the same stockholders (with the same relative amounts and type of securities) as the Corporation immediately prior to such transaction.
(d)
In any of such events, if the consideration received by this Corporation is other than cash, its value will be deemed its fair market value as determined in good faith by the Board of Directors of this Corporation. Any securities shall be valued as follows:
(i)
Securities not subject to investment letter or other similar restrictions on free marketability (other than restrictions arising solely by virtue of a stockholder’s status as an affiliate or former affiliate) shall be:
(A)
if traded on a securities exchange or through the NASDAQ Global Select Market, the NASDAQ Global Market or the NASDAQ Capital Market, the value shall be deemed to be the average of the closing prices of the securities on such exchange or system over a period of time set forth in the definitive agreement for such transaction;
(B)
if actively traded over-the-counter, the value shall be deemed to be the average of the closing bid or sale prices (whichever is applicable) over a period of time set forth in the definitive agreement for such transaction; and
(C)
if there is no active public market, the value shall be the fair market value thereof, as determined in good faith by the Board of Directors of this Corporation.
(ii)
The method of valuation of securities subject to investment letter or other restrictions on free marketability (other than restrictions arising solely by virtue of a stockholder’s status as an affiliate or former affiliate) shall be to make an appropriate discount from the value determined as above in Article IV.B.2(d)(i) to reflect the approximate fair market value thereof, as determined by the Board of Directors of this Corporation.
(e)
In the event the requirements of this Article IV.B.2(d) are not complied with, this Corporation shall forthwith either:
(i)
cause such closing to be postponed until such time as the requirements of this Article IV.B.2(d)have been complied with; or
(ii)
cancel such transaction, in which event the rights, preferences and privileges of the holders of the Series A Preferred Stock, Series B Preferred Stock and Series C Preferred Stock shall revert to and be the same as such rights, preferences and privileges existing immediately prior to the date of the first notice referred to in Article IV.B.2(f) hereof.
(f)
This Corporation shall give each holder of record of Series A Preferred Stock, Series B Preferred Stock and Series C Preferred Stock written notice of such
impending transaction not later than twenty (20) days prior to the stockholders’ meeting called to approve such transaction, or twenty (20) days prior to the closing of such transaction, whichever is earlier, and shall also notify such holders in writing of the final approval of such transaction. The first of such notices shall describe the material terms and conditions of the impending transaction, and this Corporation shall thereafter give such holders prompt notice of any material changes. The transaction shall in no event take place sooner than twenty (20) days after this Corporation has given the first notice provided for herein or sooner than ten (10) days after this Corporation has given notice of any material changes provided for herein; provided, however, that such periods may be shortened upon the written consent of the holders of Preferred Stock that are entitled to such notice rights or similar notice rights and that represent at least a majority of the voting power of all then outstanding shares of such Preferred Stock.
(g)
Allocation of Escrow and Contingent Consideration
. In the event of a Liquidation Event, if any portion of the consideration payable to the stockholders of the Corporation is payable only upon satisfaction of contingencies (the “
Additional Consideration
”), the definitive agreements for such Liquidation Event shall provide that (a) the portion of such consideration that is not Additional Consideration (such portion, the “
Initial Consideration
”) shall be allocated among the holders of capital stock of the Corporation in accordance with Article IV.B.2(a) and (b) as if the Initial Consideration were the only consideration payable in connection with such Deemed Liquidation Event; and (b) any Additional Consideration which becomes payable to the stockholders of the Corporation upon satisfaction of such contingencies shall be allocated among the holders of capital stock of the Corporation in accordance with Article IV.B.2(a) and (b) after taking into account the previous payment of the Initial Consideration as part of the same transaction. For the purposes of this Article IV.B.2(d), consideration placed into escrow or retained as holdback to be available for satisfaction of indemnification or similar obligations in connection with such Deemed Liquidation Event shall be deemed to be Additional Consideration.
3.
Redemption
. Neither the Corporation nor the holders of Preferred Stock shall have the unilateral right to call or redeem or cause to have called or redeemed any shares of the Preferred Stock.
4.
Conversion
. The holders of the Preferred Stock shall have conversion rights as follows (the “
Conversion Rights
”):
(a)
Right to Convert
. Each share of Preferred Stock shall be convertible, at the option of the holder thereof, at any time after the date of issuance of such share at the office of this Corporation or any transfer agent for such stock, into such number of fully paid and nonassessable shares of Common Stock as is determined by dividing the Original Issue Price applicable to such share by the Conversion Price applicable to such share, determined as hereafter provided, in effect on the date the certificate is surrendered for conversion. The initial Conversion Price per share for shares of Series A Preferred Stock shall be the Original Series A Issue Price, the initial Conversion Price per share for shares of Series B Preferred Stock shall be the Original Series B Issue Price and the initial Conversion Price per share for shares of Series C Preferred Stock shall be the Original Series C Issue Price; provided, however, that the
Conversion Price for Preferred Stock shall be subject to adjustment as set forth in Article IV.B.4(d).
(b)
Automatic Conversion
. Each share of Preferred Stock shall automatically be converted into shares of Common Stock at the applicable Conversion Price at the time in effect for such share of Preferred Stock immediately upon the earlier of (i) except as provided in Article IV.B.4(c), this Corporation’s sale of its Common Stock in an underwritten public offering pursuant to a registration statement under the Securities Act of 1933, as amended (the “
Act
”), the public offering price of which is not less than $6.38 per share (as adjusted for any Recapitalizations) and $40,000,000
in the aggregate (before deduction of underwriting discounts and commissions) (the “
Qualified IPO
”) or (ii) the date specified by vote or written consent of the Requisite Majority.
(c)
Mechanics of Conversion
. Before any holder of Preferred Stock shall be entitled to convert the same into shares of Common Stock, he, she or it shall surrender the certificate or certificates therefor, duly endorsed, at the office of this Corporation or of any transfer agent for the Preferred Stock, and shall give written notice to this Corporation at its principal corporate office, of the election to convert the same and shall state therein the name or names in which the certificate or certificates for shares of Common Stock are to be issued. This Corporation shall, as soon as practicable thereafter, issue and deliver at such office to such holder of Preferred Stock, or to the nominee or nominees of such holder, a certificate or certificates for the number of shares of Common Stock to which such holder shall be entitled as aforesaid. Such conversion shall be deemed to have been made immediately prior to the close of business on (i) the date of such surrender of the shares of Preferred Stock to be converted or (ii) if applicable, the date of automatic conversion specified in Article IV.B.4(b) above, and the person or persons entitled to receive the shares of Common Stock issuable upon such conversion shall be treated for all purposes as the record holder or holders of such shares of Common Stock as of such date. If the conversion is in connection with an underwritten offering of securities registered pursuant to the Act, the conversion may, at the option of any holder tendering Preferred Stock for conversion, be conditioned upon the closing with the underwriters of the sale of securities pursuant to such offering, in which event the persons entitled to receive the Common Stock upon conversion of the Preferred Stock shall not be deemed to have converted such Preferred Stock until immediately prior to the closing of such sale of securities.
(d)
Conversion Price Adjustments of Preferred Stock
. The Conversion Prices of the Preferred Stock shall be subject to adjustment from time to time as follows:
(i)
If this Corporation shall issue, after the date upon which any shares of Series C Preferred Stock were first issued (the “
Series C Purchase Date
”), any Additional Stock (as defined below) without consideration or for a consideration per share less than the Conversion Price for the Series B Preferred Stock and/or Series C Preferred Stock, as the case may be, in effect immediately prior to the issuance of such Additional Stock, the Conversion Price for the Series B Preferred Stock and/or Series C Preferred Stock, as the case may be, in effect immediately prior to each such issuance shall (except as otherwise provided in this Article IV.B.4(d)(i)) be adjusted concurrently with such issuance to a price determined by
multiplying such Conversion Price by a fraction, the numerator of which shall be the number of shares of Common Stock outstanding and deemed issued pursuant to Article IV.B.4(d)(i)(D) immediately prior to such issuance plus the number of shares of Common Stock that the aggregate consideration received by this Corporation for such issuance would purchase at such Conversion Price; and the denominator of which shall be the number of shares of Common Stock outstanding and deemed issued pursuant to Article IV.B.4(d)(i)(D) immediately prior to such issuance plus the number of shares of such Additional Stock.
(A)
No adjustment of the Conversion Price for any series of Preferred Stock shall be made in an amount less than one cent per share. Except to the limited extent provided for in Article IV.B.4(d)(i)(D)(3) and Article IV.B.4(d)(i)(D)(4), no adjustment of such Conversion Price pursuant to this Article IV.B.4(d)(i) shall have the effect of increasing the Conversion Price above the Conversion Price in effect immediately prior to such adjustment.
(B)
In the case of the issuance of Additional Stock for cash, the consideration shall be deemed to be the amount of cash paid therefor before deducting any reasonable discounts, commissions or other expenses allowed, paid or incurred by this Corporation for any underwriting or otherwise in connection with the issuance and sale thereof.
(C)
In the case of the issuance of the Additional Stock for a consideration in whole or in part other than cash, the consideration other than cash shall be deemed to be the fair market value thereof as determined by the Board of Directors irrespective of any accounting treatment.
(D)
In the case of the issuance (whether before, on or after the Series C Purchase Date) of options to purchase or rights to subscribe for Common Stock, securities by their terms convertible into or exchangeable for Common Stock or options to purchase or rights to subscribe for such convertible or exchangeable securities, the following provisions shall apply for all purposes of this Article IV.B.4(d)(i) and Article IV.B.4(d)(ii):
(1)
The aggregate maximum number of shares of Common Stock deliverable upon exercise (assuming the satisfaction of any conditions to exercisability, including, without limitation, the passage of time of such options to purchase or rights to subscribe for Common Stock shall be deemed to have been issued at the time such options or rights were issued and for a consideration equal to the consideration (determined in the manner provided in Article IV.B.4(d)(i)(B) and Article IV.B.4(d)(i)(C)), if any, received by this Corporation upon the issuance of such options or rights plus the minimum exercise price provided in such options or rights for the Common Stock covered thereby.
(2)
The aggregate maximum number of shares of Common Stock deliverable upon conversion of, or in exchange (assuming the satisfaction of any conditions to convertibility or exchangeability, including, without limitation, the passage of time, for any such convertible or exchangeable securities or upon the exercise of options to purchase or rights to subscribe for such convertible or exchangeable securities and subsequent conversion or exchange thereof shall be deemed to have been issued at the time such securities
were issued or such options or rights were issued and for a consideration equal to the consideration, if any, received by this Corporation for any such securities and related options or rights (excluding any cash received on account of accrued interest or accrued dividends), plus the minimum additional consideration, if any, to be received by this Corporation upon the conversion or exchange of such securities or the exercise of any related options or rights (the consideration in each case to be determined in the manner provided in Article IV.B.4(d)(i)(B) and Article IV.B.4(d)(i)(C)).
(3)
In the event of any change in the number of shares of Common Stock deliverable or in the consideration payable to this Corporation upon exercise of such options or rights or upon conversion of or in exchange for such convertible or exchangeable securities, including, but not limited to, a change resulting from the antidilution provisions thereof, the Conversion Price of each series of Preferred Stock, to the extent in any way affected by or computed using such options, rights or securities, shall be recomputed to reflect such change, but no further adjustment shall be made for the actual issuance of Common Stock or any payment of such consideration upon the exercise of any such options or rights or the conversion or exchange of such securities.
(4)
Upon the expiration of any such options or rights, the termination of any such rights to convert or exchange or the expiration of any options or rights related to such convertible or exchangeable securities, the Conversion Price of each series of Preferred Stock, to the extent in any way affected by or computed using such options, rights or securities or options or rights related to such securities, shall be recomputed to reflect the issuance of only the number of shares of Common Stock (and convertible or exchangeable securities that remain in effect) actually issued upon the exercise of such options or rights, upon the conversion or exchange of such securities or upon the exercise of the options or rights related to such securities.
(5)
The number of shares of Common Stock deemed issued and the consideration deemed paid therefor pursuant to Article IV.B.4(d)(i)(D)(1) and Article IV.B.4(d)(i)(D)(2) shall be appropriately adjusted to reflect any change, termination or expiration of the type described in either Article IV.B.4(d)(i)(D)(3) or Article IV.B.4(d)(i)(D)(4).
(E)
In the event that the number of shares of Additional Stock or the aggregate consideration received by this Corporation in connection with the issuance of any shares of Additional Stock cannot be ascertained at the time of issuance, such Additional Stock shall be deemed issued immediately upon the occurrence of the first event that makes such number of shares or the aggregate consideration, as applicable, ascertainable.
(F)
In the event that the Corporation issues or sells, or is deemed to have issued or sold, Additional Stock in a transaction that causes an adjustment of the Conversion Price of a series of Preferred Stock pursuant to this Article IV.B.4(d) (a “
Dilutive Issuance
”, and the first issuance or deemed issuance in connection therewith, the “
First Dilutive Issuance
”), then in the event that the Corporation issues or sells, or is deemed to have issued or sold, Additional Stock in a Dilutive Issuance other than the First Dilutive Issuance as a part of
the same transaction or series of related transactions as the First Dilutive Issuance (a “
Subsequent Dilutive Issuance
”), then and in each such case upon a Subsequent Dilutive Issuance the applicable Conversion Price shall be reduced to the Conversion Price that would have been in effect had the First Dilutive Issuance and each Subsequent Dilutive Issuance all occurred on the closing date of the First Dilutive Issuance.
(ii)
“
Additional Stock
” shall mean any shares of Common Stock issued (or deemed to have been issued pursuant to Article IV.B.4(d)(i)(D)) by this Corporation after the Series C Purchase Date other than the following (together, the “
Exempted Securities
”):
(A)
shares of Common Stock issued pursuant to a transaction described in Article IV.B.4(d)(iii) hereof;
(B)
shares of Common Stock issued or deemed issued to employees, consultants, officers, or directors of this Corporation directly or pursuant to the Company’s 2011 Stock Incentive Plan and/or pursuant to a stock option plan or restricted stock purchase plan approved by the stockholders and Board of Directors, including a majority of the Preferred Directors (as defined below);
(C)
shares of Common Stock issued or issuable (I) in the Qualified IPO before which or in connection with which all outstanding shares of Preferred Stock will be automatically converted to Common Stock, or (II) upon exercise of warrants or rights granted to underwriters in connection with such Qualified IPO, provided that such issuances, warrants or rights, as the case may be, are approved by the Board of Directors of the Corporation, including a majority of the Preferred Directors;
(D)
shares of Common Stock issued upon conversion of any shares of the Corporation’s Preferred Stock;
(E)
shares of Common Stock issued pursuant to the conversion or exercise of convertible or exercisable securities outstanding as of the Series C Purchase Date or subsequently issued after the Series C Purchase Date in accordance with this Article IV.B.4(d)(ii);
(F)
shares of Common Stock issued or issuable in connection with a bona fide business acquisition of another corporation by this Corporation, whether by merger, purchase of substantially all of the assets or other reorganization or pursuant to a joint venture agreement, provided that such issuances are approved by the Board of Directors of the Corporation, including a majority of the Preferred Directors;
(G)
shares of Common Stock issued or issuable to financial institutions or lessors in connection with commercial credit arrangements, equipment financings, commercial property lease transactions or similar transactions, provided such issuances are for other than primarily equity financing purposes and are approved by the Board of Directors of the Corporation, including a majority of the Preferred Directors;
(H)
shares of Common Stock issued or issuable in connection with sponsored research, collaboration, technology license, development, OEM, marketing or other similar agreements or strategic partnerships approved by the Board of Directors of the Corporation, including a majority of the Preferred Directors; or
(I)
shares of Common Stock issued or issuable in connection with any transaction where such securities so issued are excepted from the definition “
Additional Stock
” by the affirmative vote of the Requisite Majority.
(iii)
In the event this Corporation should at any time or from time to time after the Series C Purchase Date fix a record date for the effectuation of a split or subdivision of the outstanding shares of Common Stock or the determination of holders of Common Stock entitled to receive a dividend or other distribution payable in additional shares of Common Stock or other securities or rights convertible into, or entitling the holder thereof to receive directly or indirectly, additional shares of Common Stock (hereinafter referred to as “
Common Stock Equivalents
”) without payment of any consideration by such holder for the additional shares of Common Stock or the Common Stock Equivalents (including the additional shares of Common Stock issuable upon conversion or exercise thereof), then, as of such record date (or the date of such dividend distribution, split or subdivision if no record date is fixed), the Conversion Prices of each series of Preferred Stock shall be appropriately decreased so that the number of shares of Common Stock issuable on conversion of each share of such series shall be increased in proportion to such increase in the aggregate number of shares of Common Stock outstanding and those issuable with respect to such Common Stock Equivalents.
(iv)
If the number of shares of Common Stock outstanding at any time after the Series C Purchase Date is decreased by a combination of the outstanding shares of Common Stock, then, following the record date of such combination, the Conversion Prices for each series of Preferred Stock shall be appropriately increased so that the number of shares of Common Stock issuable on conversion of each share of such series shall be decreased in proportion to such decrease in outstanding shares.
(e)
Other Distributions
. In the event this Corporation shall declare a distribution payable in securities of other persons, evidences of indebtedness issued by this Corporation or other persons, assets (excluding cash dividends) or options or rights not referred to in Article IV.B.4(d)(iii), then, in each such case for the purpose of this Article IV.B.4(e), the holders of each series of Preferred Stock shall be entitled to a proportionate share of any such distribution as though they were the holders of the number of shares of Common Stock of this Corporation into which their shares of such series of Preferred Stock are convertible as of the record date fixed for the determination of the holders of Common Stock of this Corporation entitled to receive such distribution.
(f)
Recapitalizations
. If at any time or from time to time there shall be a recapitalization of the Common Stock (other than a subdivision, combination or merger or sale of assets transaction provided for elsewhere in Article IV.B.2 or this Article IV.B.4) provision shall be made so that the holders of each series of the Preferred Stock shall thereafter be entitled to receive upon conversion of such series of Preferred Stock the number of shares of stock or
other securities or property of this Corporation or otherwise, to which a holder of the number of shares of Common Stock deliverable upon conversion of the Preferred Stock held by such holder would have been entitled on such recapitalization. In any such case, appropriate adjustment shall be made in the application of the provisions of this Article IV.B.4 with respect to the rights of the holders of each series of Preferred Stock after the recapitalization to the end that the provisions of this Article IV.B.4 (including adjustment of the Conversion Price then in effect and the number of shares purchasable upon conversion of each such series of Preferred Stock) shall be applicable after that event as nearly equivalent as may be practicable.
(g)
No Fractional Shares and Certificate as to Adjustments
,
(i)
No fractional shares shall be issued upon the conversion of any share or shares of Preferred Stock. In lieu of any fractional shares to which the holder would otherwise be entitled, the Corporation shall pay cash equal to such fraction multiplied by the then fair market value of a share of Common Stock as determined in good faith by the Board of Directors. The number of shares of Common Stock to be issued upon such conversion shall be determined on the basis of the total number of shares of Preferred Stock the holder is at the time converting into Common Stock and the number of shares of Common Stock issuable upon such aggregate conversion.
(ii)
Upon the occurrence of each adjustment or readjustment of the Conversion Price of any series of Preferred Stock pursuant to this Article IV.B.4, this Corporation, at its expense, shall promptly compute such adjustment or readjustment in accordance with the terms hereof and prepare and furnish to each holder of such series of Preferred Stock a certificate setting forth such adjustment or readjustment and showing in detail the facts upon which such adjustment or readjustment is based. This Corporation shall, upon the written request at any time of any holder of Preferred Stock, furnish or cause to be furnished to such holder a like certificate setting forth (A) such adjustment and readjustment, (B) the Conversion Price for such series of Preferred Stock at the time in effect, and (C) the number of shares of Common Stock and the amount, if any, of other property that at the time would be received upon the conversion of a share of such series of Preferred Stock.
(h)
Notices of Record Date
. In the event of any taking by this Corporation of a record of the holders of any class of securities for the purpose of determining the holders thereof who are entitled to receive any dividend (other than a cash dividend) or other distribution, any right to subscribe for, purchase or otherwise acquire any shares of stock of any class or any other securities or property, or to receive any other right, this Corporation shall mail to each holder of Preferred Stock, at least twenty (20) days prior to the date specified therein, a notice specifying the date on which any such record is to be taken for the purpose of such dividend, distribution or right, and the amount and character of such dividend, distribution or right.
(i)
Reservation of Stock Issuable Upon Conversion
. This Corporation shall at all times reserve and keep available out of its authorized but unissued shares of Common Stock, solely for the purpose of effecting the conversion of the shares of Preferred Stock, such number of its shares of Common Stock as shall from time to time be sufficient to effect the
conversion of all outstanding shares of Preferred Stock; and if at any time the number of authorized but unissued shares of Common Stock shall not be sufficient to effect the conversion of all then outstanding shares of Preferred Stock, in addition to such other remedies as shall be available to the holder of such Preferred Stock, this Corporation will take such corporate action as may, in the opinion of its counsel, be necessary to increase its authorized but unissued shares of Common Stock to such number of shares as shall be sufficient for such purposes, including, without limitation, engaging in best efforts to obtain the requisite stockholder approval of any necessary amendment to this Amended and Restated Certificate of Incorporation.
(j)
Notices
. Any notice required by the provisions of this Article IV.B.4 to be given to the holders of shares of Preferred Stock shall be deemed given if deposited in the United States mail, postage prepaid, and addressed to each holder of record at his address appearing on the books of this Corporation.
(k)
Waiver of Adjustment to Conversion Prices
. Notwithstanding anything herein to the contrary, any downward adjustment of the Conversion Price of any series of Preferred Stock may be waived, either prospectively or retroactively and either generally or in a particular instance by the vote or written consent of the holders of a majority of such series of Preferred Stock. Any such waiver shall be binding upon all current and future holders of shares of such series of Preferred Stock.
5.
Voting Rights
.
(a)
Preferred Stock
. The holder of each share of Series B Preferred Stock and Series C Preferred Stock shall have the right to one vote for each share of Common Stock into which such share of Series B Preferred Stock or Series C Preferred Stock, as the case may be, could then be converted. With respect to such vote and except as otherwise expressly provided herein or as required by applicable law, such holder shall have full voting rights and powers equal to the voting rights and powers of the holders of Common Stock, and shall be entitled, notwithstanding any provision hereof, to notice of any stockholders’ meeting in accordance with the Bylaws of this Corporation, and shall be entitled to vote, together with holders of Common Stock as a single class, with respect to any matter upon which holders of Common Stock have the right to vote. Fractional votes shall not, however, be permitted and any fractional voting rights available on an as-converted basis (after aggregating all shares into which shares of Series B Preferred Stock and Series C Preferred Stock held by each holder could be converted) shall be rounded to the nearest whole number (with one-half being rounded upward). Except as expressly set forth herein, the shares of Series A Preferred Stock shall not have any voting rights.
(b)
Authorized Shares of Common Stock
. The number of authorized shares of Common Stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of shares of stock of the Corporation representing a majority of the votes represented by all of the outstanding shares of stock of the Corporation entitled to vote, irrespective of the provisions of Section 242(b)(2) of the General Corporation Law.
6.
Protective Provisions
.
(a)
So long as at least 1,500,000 shares of Preferred Stock are outstanding (as adjusted for any Recapitalizations), the Corporation shall not, either directly or indirectly by amendment, merger, consolidation or otherwise, do any of the following without (in addition to any other vote required by law or the Certificate of Incorporation) the written consent or affirmative vote of the Requisite Majority, given in writing or by vote at a meeting, consenting or voting (as the case may be) separately as a class, and any such act or transaction entered into without such consent or vote shall be null and void
ab initio
, and of no force or effect:
(i)
increase the aggregate number of shares of Common Stock reserved for issuance pursuant to the Company’s 2011 Stock Incentive Plan, or any other similar plan;
(ii)
create, or authorize the creation of, or issue or obligate itself to issue shares of, any additional class or series of capital stock unless the same ranks junior to the Preferred Stock with respect to the distribution of assets on the liquidation, dissolution or winding up of the Corporation, the payment of dividends and rights of redemption,
(iii)
effect any a Liquidation Event;
(iv)
alter or change, whether by merger, consolidation or otherwise, the rights, preferences or privileges of the shares of Preferred Stock so as to affect adversely such shares of Preferred Stock;
(v)
increase or decrease the authorized number of directors of the Corporation;
(vi)
declare or pay dividends or make other distributions on the capital stock of the Corporation;
(vii)
redeem, purchase or otherwise acquire (or pay into or set aside for a sinking fund for such purpose) any share or shares of Common Stock; provided, however, that this restriction shall not apply to the repurchase of shares of Common Stock from employees, officers, directors, consultants or other persons performing services for this Corporation or any subsidiary pursuant to agreements under which this Corporation has the option to repurchase such shares at cost upon the occurrence of certain events, such as the termination of employment or other provision of services to the Corporation; provided further, that such repurchases are approved by the Board of Directors of the Corporation;
(viii)
incur any indebtedness for borrowed money in excess of $500,000 in the aggregate other than payables incurred in the ordinary course of business; or
(ix)
for any action which would result in the taxation of Preferred Stock under Section 305 of the Internal Revenue Code of 1986, as amended.
(b)
So long as at least 7,150 shares of Series A Preferred Stock are outstanding (as adjusted for Recapitalizations), this Corporation shall not without first obtaining the approval (by vote or written consent, as provided by law) of at least a majority of the then outstanding shares of Series A Preferred Stock voting separately as a single class and on an as-converted basis:
(i)
amend, waive or appeal any provision of this Amended and Restated Certificate of Incorporation or Bylaws of the Corporation (whether by merger, consolidation or otherwise) in a manner that adversely affects the powers, preferences or rights of the Series A Preferred Stock in a manner different from any other series of Preferred Stock; or
(ii)
increase or decrease (other than by redemption or conversion) the total number of authorized shares of Series A Preferred Stock.
(c)
So long as at least 750,000 shares of Series B Preferred Stock are outstanding (as adjusted for Recapitalizations), this Corporation shall not without first obtaining the approval (by vote or written consent, as provided by law) of at least a majority of the then outstanding shares of Series B Preferred Stock voting separately as a single class:
(i)
amend, waive or appeal any provision of this Amended and Restated Certificate of Incorporation or Bylaws of the Corporation (whether by merger, consolidation or otherwise) in a manner that adversely affects the powers, preferences or rights of the Series B Preferred Stock in a manner different from any other series of Preferred Stock; or
(ii)
increase or decrease (other than by redemption or conversion) the total number of authorized shares of Series B Preferred Stock.
(d)
So long as at least 750,000 shares of Series C Preferred Stock are outstanding (as adjusted for Recapitalizations), this Corporation shall not without first obtaining the approval (by vote or written consent, as provided by law) of at least a majority of the then outstanding shares of Series C Preferred Stock voting separately as a single class:
(i)
amend, waive or appeal any provision of this Amended and Restated Certificate of Incorporation or Bylaws of the Corporation (whether by merger, consolidation or otherwise) in a manner that adversely affects the powers, preferences or rights of the Series C Preferred Stock in a manner different from any other series of Preferred Stock; or
(ii)
increase or decrease (other than by redemption or conversion) the total number of authorized shares of Series C Preferred Stock.
7.
Status of Redeemed or Converted Stock
. In the event any shares of Preferred Stock shall be converted pursuant to Article IV.B.4 or redeemed, the shares so redeemed or converted shall be cancelled and shall not be issuable by this Corporation. This Amended and Restated Certificate of Incorporation shall be appropriately amended to effect the corresponding reduction in this Corporation’s authorized capital stock.
8.
Election of Directors
. The holders of record of the shares of Series A Preferred Stock, exclusively and as a separate class, shall be entitled to elect two (2) directors of the Corporation (the “
Series A Directors
”), the holders of record of the shares of Series B Preferred Stock, exclusively and as a separate class, shall be entitled to elect two (2) directors of the Corporation (the “
Series B Directors
”), the holders of record of the shares of Series C Preferred Stock, exclusively and as a separate class, shall be entitled to elect one (1) directors of the Corporation (the “
Series C Director
,” and together with the Series A Directors and the Series B Directors, the “
Preferred Directors
”) and the holders of record of the shares of Common Stock, exclusively and as a separate class, shall be entitled to elect three (3) directors of the Corporation. Any director elected as provided in the preceding sentence may be removed without cause by, and only by, the affirmative vote of the holders of the shares of the class or series of capital stock entitled to elect such director or directors, given either at a special meeting of such stockholders duly called for that purpose or pursuant to a written consent of stockholders. If the holders of shares of Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock or Common Stock, as the case may be, fail to elect a sufficient number of directors to fill all directorships for which they are entitled to elect directors, voting exclusively and as a separate class, pursuant to the first sentence of this Article IV.B.8, then any directorship not so filled shall remain vacant until such time as the holders of the Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock or Common Stock, as the case may be, elect a person to fill such directorship by vote or written consent in lieu of a meeting; and no such directorship may be filled by stockholders of the Corporation other than by the stockholders of the Corporation that are entitled to elect a person to fill such directorship, voting exclusively and as a separate
class. The holders of record of the shares of Common Stock and of any other class or series of voting stock (including the Preferred Stock), exclusively and voting together as a single class, shall be entitled to elect the balance of the total number of directors of the Corporation. At any meeting held for the purpose of electing a director, the presence in person or by proxy of the holders of a majority of the outstanding shares of the class or series entitled to elect such director shall constitute a quorum for the purpose of electing such director. Except as otherwise provided in this Article IV.B.8, a vacancy in any directorship filled by the holders of any class or series shall be filled only by vote or written consent in lieu of a meeting of the holders of such class or series or by any remaining director or directors elected by the holders of such class or series pursuant to this Article IV.B.8.
C.
Common Stock
. The rights, preferences, privileges and restrictions granted to and imposed on the Common Stock are as set forth below in this Article IV.C.
1.
Dividend Rights
. Subject to the prior rights of holders of all classes of stock at the time outstanding having prior rights as to dividends, the holders of the Common Stock shall be entitled to receive, when and as declared by the Board of Directors, out of any assets of this Corporation legally available therefor, such dividends as may be declared from time to time by the Board of Directors.
2.
Liquidation Rights
. Upon a Liquidation Event, the assets of this Corporation shall be distributed as provided in Article IV.B.2.
3.
Redemption
. Except as may otherwise be provided in a written agreement between the Corporation and a holder of Common Stock or the Bylaws of this Corporation, neither the Corporation nor the holders of Common Stock shall have the unilateral right to call or redeem or cause to have called or redeemed any shares of Common Stock.
4.
Voting Rights
. The holder of each share of Common Stock shall have the right to one vote for each such share, and shall be entitled to notice of any stockholders’ meeting in accordance with the Bylaws of this Corporation, and shall be entitled to vote upon such matters and in such manner as may be provided by law; provided, however, that except as otherwise required by law, the holders of Common Stock, as such, shall not be entitled to vote on any amendment to this Amended and Restated Certificate of Incorporation (including any Certificate of Designation relating to any series of Preferred Stock) that relates solely to the terms of one or more outstanding series of Preferred Stock if the holders of such affected series are entitled, either separately or together with the holders of one or more other such series, to vote thereon pursuant to this Amended and Restated Certificate of Incorporation (including any Certificate of Designation relating to any series of Preferred Stock) or pursuant to the General Corporation Law.
Article V.
Whenever a compromise or arrangement is proposed between the Corporation and its creditors or any class of them and/or between the Corporation 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 the Corporation or of any creditor or stockholder thereof or on the application of any receiver or receivers appointed for the Corporation under the provisions of Section 291 of the General Corporation Law or on the application of trustees in dissolution or of any receiver or receivers appointed for the Corporation under the provisions of Section 279 of the General Corporation Law, order a meeting of the creditors or class of creditors, and/or of the stockholders or class of stockholders of the Corporation, 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 the Corporation, as the case may be, agree to any compromise or arrangement and to any reorganization of the Corporation 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 the said application has been made, be binding on all the creditors or class of creditors, and/or on all the stockholders or class of stockholders, of the Corporation, as the case may be, and also on the Corporation.
Article VI.
No director shall be personally liable to the Corporation or any of its stockholders for monetary damages for breach of fiduciary duty as a director, except to the extent such exemption from liability or limitation thereof is not permitted under the General Corporation Law as the same exists or may hereafter be amended. If the General Corporation Law is amended hereafter to authorize the further elimination or limitation of the liability of directors, then the liability of a director of the Corporation shall be eliminated or limited to the fullest extent authorized by the
General Corporation Law, as so amended. Any repeal or modification of this Article VI shall not adversely affect any right or protection of a director of the Corporation existing at the time of such repeal or modification with respect to acts or omissions occurring prior to such repeal or modification.
Article VII.
The Corporation shall indemnify its directors and officers to the extent set forth in the by-laws of the Corporation.
Article VIII.
The number of directors of the Corporation shall be as from time to time fixed by, or in the manner provided in, the by-laws of the Corporation. Unless, and except to the extent that, the by-laws of the Corporation shall so require, the election of directors of the Corporation need not be by written ballot. In addition to the powers and authority hereinbefore or by statute expressly conferred upon them, the directors are hereby empowered to exercise all such powers and do all such acts and things as may be exercised or done by the Corporation, subject, nevertheless, to the provisions of the General Corporation Law, this Certificate of Incorporation and any by-laws adopted by the stockholders of the Corporation;
provided
, that no by-laws hereafter adopted by the stockholders of the Corporation shall invalidate any prior act of the directors which would have been valid if such by-laws had not been adopted.
Article IX.
The Corporation renounces, to the fullest extent permitted by law, any interest or expectancy of the Corporation in, or in being offered an opportunity to participate in, any Excluded Opportunity. An “
Excluded Opportunity
” is any matter, transaction or interest that is presented to, or acquired, created or developed by, or which otherwise comes into the possession of (i) any director of the Corporation who is not an employee of the Corporation or any of its subsidiaries, or (ii) any holder of Preferred Stock or any partner, member, director, stockholder, employee or agent of any such holder, other than someone who is an employee of the Corporation 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 Person’s capacity as a director of the Corporation. No amendment or repeal of this Article IX shall apply to or have any effect on the liability or alleged liability of any officer, director or stockholder of the Corporation for or with respect to any opportunities of which such other, director, or stockholder becomes aware prior to such amendment or repeal.
Article X.
The Corporation reserves the right to amend, alter, change or repeal any provision contained in this Certificate of Incorporation in the manner now or hereafter prescribed herein, and by the laws of the State of Delaware, and all rights conferred upon stockholders herein are granted subject to this reservation.
Article XI.
The Corporation hereby confers the power to adopt, amend or repeal by-laws of the Corporation upon the directors,
provided
, that the stockholders of the Corporation may adopt any additional by-laws or amend or repeal any existing by-laws, whether or not adopted by them.
Article XII.
Unless the Corporation consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of the Corporation, (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of the Corporation to the Corporation or the Corporation’s stockholders, (iii) any action asserting a claim arising pursuant to any provision of the General Corporation Law, or (iv) any action asserting a claim governed by the internal affairs doctrine, in each such case subject to said Court of Chancery having personal jurisdiction over the indispensable parties named as defendants therein. Any person or entity purchasing or otherwise acquiring any interest in shares of capital stock of the Corporation shall be deemed to have notice of and consented to the provisions of this Article XII.
Article XIII.
The Corporation expressly elects not to be governed by Section 203 of the General Corporation Law of the State of Delaware.
* * *
MENLO THERAPEUTICS INC.
AMENDED AND RESTATED CERTIFICATE OF INCORPORATION
Menlo Therapeutics Inc., a corporation organized and existing under and by virtue of the Delaware General Corporation Law, hereby certifies as follows:
The name of the corporation is Menlo Therapeutics Inc. The original Certificate of Incorporation of the corporation was filed with the Secretary of State of the State of Delaware on October 21, 2011 under the name Tigercat Pharma, Inc.
The Amended and Restated Certificate of Incorporation in the form of
Exhibit A
attached hereto has been duly adopted in accordance with the provisions of Sections 242, 245 and 228 of the Delaware General Corporation Law.
The text of the Amended and Restated Certificate of Incorporation as heretofore amended or supplemented is hereby restated and further amended to read in its entirety as set forth in
Exhibit A
attached hereto. The Amended and Restated Certificate of Incorporation shall be effective as of 9:00 a.m. Eastern Time on [__________], 2018.
IN WITNESS WHEREOF
, this Amended and Restated Certificate of Incorporation has been signed this day of [__________], 2018.
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MENLO THERAPEUTICS INC.
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By:
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Steven L. Basta
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President and Chief Executive Officer
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EXHIBIT A
AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION OF
MENLO THERAPEUTICS INC.
ARTICLE I
NAME
The name of the corporation is Menlo Therapeutics Inc. (the “
Corporation
”).
ARTICLE II
REGISTERED OFFICE AND AGENT
The address of the Corporation’s registered office in the State of Delaware is 1209 Orange Street, in the City of Wilmington, County of New Castle, 19801. The name of its registered agent at such address is The Corporation Trust Company.
ARTICLE III
PURPOSE AND DURATION
The purpose of the Corporation is to engage in any lawful act or activity for which a corporation may be organized under the Delaware General Corporation Law. The Corporation is to have a perpetual existence.
ARTICLE IV
CAPITAL STOCK
Section 1.
This Corporation is authorized to issue two classes of capital stock which shall be designated, respectively, “Common Stock” and “Preferred Stock.” The total number of shares that the Corporation is authorized to issue is 320,000,000, of which 300,000,000 shares shall be Common Stock and 20,000,000 shares shall be Preferred Stock. The Common Stock shall have a par value of $0.0001 per share and the Preferred Stock shall have a par value of $0.0001 per share. Subject to the rights of the holders of any series of Preferred Stock, the number of authorized shares of any of the Common Stock or Preferred Stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of a majority in voting power of the stock of the Corporation with the power to vote thereon irrespective of the provisions of Section 242(b)(2) of the Delaware General Corporation Law or any successor provision thereof, and no vote of the holders of any of the Common Stock or Preferred Stock voting separately as a class shall be required therefor.
Section 2.
Shares of Preferred Stock may be issued from time to time in one or more series. The Board of Directors of the Corporation (the “
Board of Directors
”) is hereby authorized to provide from time to time by resolution or resolutions for the creation and issuance, out of the authorized and unissued shares of Preferred Stock, of one or more series of Preferred Stock by filing a certificate (a “
Certificate of Designation
”) pursuant to the Delaware General Corporation Law, setting forth such resolution and, with respect to each such series, establishing the designation of such series and the number of shares to be included in such series and fixing the voting powers (full or limited, or no voting power), preferences and relative, participating, optional or other special rights, and the qualifications, limitations and restrictions thereof, of the shares of each such series. Without limiting the generality of the foregoing, the resolution or resolutions providing for the establishment of any series of Preferred Stock may, to the extent permitted by law, provide that such series shall be superior to, rank equally with or be junior to the Preferred Stock of any other series. The powers, preferences and relative, participating, optional and other special rights of each series of Preferred Stock, and the qualifications, limitations or restrictions thereof, if any, may be different from those of any and all other series at any time outstanding. Except as otherwise expressly provided in the resolution or resolutions providing for the establishment of any series of Preferred Stock, no vote of the holders of shares of Preferred Stock or Common Stock shall be a prerequisite to the issuance of any shares of any series of the Preferred Stock so
authorized in accordance with this Amended and Restated Certificate of Incorporation. Unless otherwise provided in the Certificate of Designation establishing a series of Preferred Stock, the Board of Directors may, by resolution or resolutions, increase or decrease (but not below the number of shares of such series then outstanding) the number of shares of such series and, if the number of shares of such series shall be so decreased, the shares constituting such decrease shall resume the status that they had prior to the adoption of the resolution originally fixing the number of shares of such series.
Section 3.
At the effective time (the “
Effective Time
”) of this Amended and Restated Certificate of Incorporation (the “
Certificate of Incorporation
”), each one (1) share of Series A Preferred (as defined in the Amended and Restated Certificate of Incorporation) shall, automatically and without further action by any stockholder, be converted into one (1) share of Common Stock; each one (1) share of Series B Preferred (as defined in the Amended and Restated Certificate of Incorporation) shall, automatically and without further action by any stockholder, be converted into one (1) share of Common Stock; and each one (1) share of Series C Preferred (as defined in the Amended and Restated Certificate of Incorporation) shall, automatically and without further action by any stockholder, be converted into one (1) share of Common Stock.
ARTICLE V
BOARD OF DIRECTORS
For the management of the business and for the conduct of the affairs of the Corporation it is further provided that:
Section 1.
(a) The management of the business and the conduct of the affairs of the Corporation shall be vested in the Board of Directors. The number of directors which shall constitute the whole Board of Directors shall be fixed exclusively by one or more resolutions adopted from time to time by the Board of Directors. Except as otherwise expressly delegated by resolution of the Board of Directors, the Board of Directors shall have the exclusive power and authority to appoint and remove officers of the Corporation.
(b) Other than any directors elected by the separate vote of the holders of one or more series of Preferred Stock, the Board of Directors shall be and is divided into three classes, designated as Class I, Class II and Class III, as nearly equal in number as possible. Directors shall be assigned to each class in accordance with a resolution or resolutions adopted by the Board of Directors. At the first annual meeting of stockholders following the effectiveness of this Amended and Restated Certificate of Incorporation (the “
Qualifying Record Date
”), the term of office of the Class I directors shall expire and Class I directors shall be elected for a full term of three years. At the second annual meeting of stockholders following the Qualifying Record Date, the term of office of the Class II directors shall expire and Class II directors shall be elected for a full term of three years. At the third annual meeting of stockholders following the Qualifying Record Date, the term of office of the Class III directors shall expire and Class III directors shall be elected for a full term of three years. Subject to the special rights of the holders of one or more series of Preferred Stock to elect directors, at each succeeding annual meeting of stockholders, directors shall be elected for a full term of three years to succeed the directors of the class whose terms expire at such annual meeting.
Notwithstanding the foregoing provisions of this Article V, Section 1(b), each director shall serve until his or her successor is duly elected and qualified or until his or her earlier death, resignation, disqualification, retirement or removal. No decrease in the number of directors constituting the Board of Directors shall shorten the term of any incumbent director.
(c) Subject to the special rights of the holders of one or more series of Preferred Stock to elect directors, the Board of Directors or any individual director may be removed from office at any time, but only for cause and only by the affirmative vote of the holders of sixty-six and two-thirds percent (66-2/3%) of the voting power of all the then outstanding shares of voting stock of the Corporation with the power to vote at an election of directors (the “
Voting Stock
”).
(d) Subject to the special rights of the holders of one or more series of Preferred Stock to elect directors, any vacancies on the Board of Directors resulting from death, resignation, disqualification, retirement, removal or other causes and any newly created directorships resulting from any increase in the number of directors shall, unless the Board of Directors determines by resolution that any such vacancies or newly created directorships shall be filled by the stockholders, and except as otherwise provided by law, be filled only by the affirmative vote of a majority of the directors then in office, even though less than a quorum, or by a sole remaining director, and shall not be filled by the stockholders. Any director appointed in accordance with the preceding sentence shall hold office for a term that shall coincide with the remaining term of the class to which the
director shall have been appointed and until such director’s successor shall have been elected and qualified or until his or her earlier death, resignation, disqualification, retirement or removal.
Section 2.
(a) In furtherance and not in limitation of the powers conferred by statute, the Board of Directors is expressly authorized to make, alter or repeal Bylaws of the Corporation. In addition to any vote of the holders of any class or series of stock of the Corporation required by applicable law or by this Amended and Restated Certificate of Incorporation (including any Certificate of Designation in respect of one or more series of Preferred Stock), the adoption, amendment or repeal of the Bylaws of the Corporation by the stockholders of the Corporation shall require the affirmative vote of the holders of at least sixty-six and two-thirds percent (66-2/3%) of the voting power of all the then-outstanding shares of the Voting Stock, voting together as a single class.
(b) The directors of the Corporation need not be elected by written ballot unless the Bylaws so provide.
ARTICLE VI
STOCKHOLDERS
Section 1.
Subject to the special rights of the holders of one or more series of Preferred Stock, any action required or permitted to be taken by the stockholders of the Corporation must be effected at a duly called annual or special meeting of the stockholders of the Corporation, and the taking of any action by written consent of the stockholders in lieu of a meeting of the stockholders is specifically denied.
Section 2.
Subject to the special rights of the holders of one or more series of Preferred Stock, special meetings of the stockholders of the Corporation may be called, for any purpose or purposes, at any time by the Board of Directors, chairperson of the Board of Directors, chief executive officer or president (in the absence of a chief executive officer), but such special meetings may not be called by stockholders or any other person or persons.
Section 3.
Advance notice of stockholder nominations for the election of directors and of other business proposed to be brought by stockholders before any meeting of the stockholders of the Corporation shall be given in the manner provided in the Bylaws of the Corporation.
ARTICLE VII
LIABILITY AND INDEMNIFICATION
Section 1.
To the fullest extent permitted by the Delaware General Corporation Law, as the same exists or as may hereafter be amended, a director of the Corporation shall not be personally liable to the Corporation or its stockholders for monetary damages for breach of fiduciary duty as a director. If the Delaware General Corporation Law is amended after approval by the stockholders of this Article VII to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of a director of the Corporation shall be eliminated or limited to the fullest extent permitted by the Delaware General Corporation Law as so amended, automatically and without further action, upon the date of such amendment.
Section 2.
The Corporation, to the fullest extent permitted by law, shall indemnify and advance expenses to any person made or threatened to be made a party to an action, suit or proceeding, whether criminal, civil, administrative or investigative, by reason of the fact that he or she, or his or her testator or intestate, is or was a director or officer of the Corporation or any predecessor of the Corporation, or serves or served at any other enterprise as a director or officer at the request of the Corporation or any predecessor to the Corporation.
Section 3.
The Corporation, to the fullest extent permitted by law, may indemnify and advance expenses to any person made or threatened to be made a party to an action, suit or proceeding, whether criminal, civil, administrative or investigative, by reason of the fact that he or she, or his or her testator or intestate, is or was an employee or agent of the Corporation or any predecessor of the Corporation, or serves or served at any other enterprise as an employee or agent at the request of the Corporation or any predecessor to the Corporation.
Section 4.
Neither any amendment nor repeal of this Article VII, nor the adoption by amendment of this certificate of incorporation of any provision inconsistent with this Article VII, shall eliminate or reduce the effect of this Article VII in respect of any matter occurring, or any action or proceeding accruing or arising (or that, but for this Article VII, would accrue or arise) prior to such amendment or repeal or adoption of an inconsistent provision.
ARTICLE VIII
EXCLUSIVE FORUM
Unless the Corporation consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall, to the fullest extent permitted by law, be the sole and exclusive forum for (1) any derivative action or proceeding brought on behalf of the Corporation, (2) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of the Corporation to the Corporation or the Corporation’s stockholders, (3) any action asserting a claim arising pursuant to any provision of the Delaware General Corporation Law, this Amended and Restated Certificate of Incorporation or the Bylaws, or (4) any action asserting a claim governed by the internal affairs doctrine. Any person or entity purchasing or otherwise acquiring or holding any interest in shares of capital stock of the Corporation shall be deemed to have notice of and consented to the provisions of this Article VIII.
ARTICLE IX
AMENDMENTS
Notwithstanding any other provisions of this Amended and Restated Certificate of Incorporation or any provision of law which might otherwise permit a lesser vote or no vote, but in addition to any affirmative vote of the holders of any particular class or series of the Voting Stock required by law or by this Amended and Restated Certificate of Incorporation (including any Certificate of Designation in respect of one or more series of Preferred Stock), the affirmative vote of the holders of at least sixty-six and two-thirds percent (66-2/3%) of the voting power of all of the then-outstanding shares of the Voting Stock, voting together as a single class, shall be required to alter, amend or repeal Articles V, VI, VII and VIII and this Article IX.
* * * *
Exhibit 3.4
EXECUTION VERSION
BYLAWS
OF
TIGERCAT PHARMA, INC
a Delaware Corporation
Effective December 9, 2011
TABLE OF CONTENTS
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Page
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ARTICLE I
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OFFICES
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1
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Section 1.
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Registered Office
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1
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Section 2.
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Other Offices
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ARTICLE II
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MEETINGS OF STOCKHOLDERS
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Section 1.
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Place of Meetings
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1
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Section 2.
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Annual Meetings.
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1
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Section 3.
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Special Meetings.
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1
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Section 4.
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Notice
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1
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Section 5.
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Adjournments
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1
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Section 6.
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Quorum
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1
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Section 7.
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Voting
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1
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Section 8.
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Proxies
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1
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Section 9.
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Consent of Stockholders in Lieu of Meeting
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2
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Section 10.
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List of Stockholders Entitled to Vote
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2
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Section 11.
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Record Date.
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3
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Section 12.
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Stock Ledger
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3
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Section 13.
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Conduct of Meetings
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3
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ARTICLE III
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DIRECTORS
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5
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Section 1.
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Number and Election of Directors
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5
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Section 2.
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Vacancies
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5
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Section 3.
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Duties and Powers
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5
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Section 4.
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Meetings
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5
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Section 5.
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Organization
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5
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Section 6.
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Resignations and Removals of Directors
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6
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Section 7.
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Quorum
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6
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Section 8.
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Actions of the Board by Written Consent
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6
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Section 9.
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Meetings by Means of Conference Telephone
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6
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Section 10.
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Committees
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6
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Section 11.
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Compensation
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7
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Section 12.
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Interested Directors
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7
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ARTICLE IV
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OFFICERS
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8
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Section 1.
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General
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8
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Section 2.
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Election
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8
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Section 3.
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Voting Securities Owned by the Corporation
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8
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Section 4.
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Chairman of the Board of Directors
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8
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Section 5.
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President
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8
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Section 6.
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Vice Presidents
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9
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Section 7.
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Secretary
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9
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Section 8.
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Treasurer
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9
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Section 9.
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Assistant Secretaries
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10
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Section 10.
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Assistant Treasurers
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10
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Section 11.
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Other Officers
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10
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ARTICLE V
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STOCK
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11
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Section 1.
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Form of Certificates
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11
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Section 2.
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Signatures
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11
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Section 3.
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Lost Certificates
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11
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Section 4.
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Transfers
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11
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Section 5.
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Dividend Record Date
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11
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Section 6.
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Record Owners
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12
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Section 7.
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Transfer and Registry Agents
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12
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ARTICLE VI
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NOTICES
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13
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Section 1.
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Notices
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13
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Section 2.
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Waivers of Notice
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13
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ARTICLE VII
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GENERAL PROVISIONS
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13
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Section 1.
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Dividends
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13
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Section 2.
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Disbursements
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13
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Section 3.
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Fiscal Year
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13
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Section 4.
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Corporate Seal
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13
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Section 5.
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Affixing Seal
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14
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ARTICLE VIII
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INDEMNIFICATION
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15
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Section 1.
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Power to Indemnify in Actions, Suits or Proceedings other than Those by or in the Right of the Corporation
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15
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Section 2.
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Power to Indemnify in Actions, Suits or Proceedings by or in the Right of the Corporation
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Section 3.
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Authorization of Indemnification
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15
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Section 4.
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Good Faith Defined
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16
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Section 5.
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Indemnification by a Court
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16
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Section 6.
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Expenses Payable in Advance
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16
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Section 7.
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Nonexclusivity of Indemnification and Advancement of Expenses
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16
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Section 8.
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Insurance
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17
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Section 9.
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Certain Definitions
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17
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Section 10.
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Survival of Indemnification and Advancement of Expenses
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17
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Section 11.
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Limitation on Indemnification
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17
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Section 12.
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Indemnification of Employees and Agents
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18
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Section 13.
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Amendment or Repeal
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18
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ARTICLE IX
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MISCELLANEOUS
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19
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Section 1.
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Amendments
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19
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Section 2.
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Entire Board of Directors
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19
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Section 3.
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Stockholders Agreement
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19
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Section 4.
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Forum for Adjudication of Disputes
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19
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BYLAWS
OF
TIGERCAT PHARMA, INC.
(hereinafter called the "Corporation")
ARTICLE I
OFFICES
Section 1.
Registered Office
. The registered office of the Corporation shall be in the City of Wilmington, County of New Castle, State of Delaware.
Section 2.
Other Offices
. The Corporation may also have offices at such other places, both within and without the State of Delaware, as the Board of Directors of the Corporation (the
"
Board of Directors”) may from time to time determine.
A
RTICLE II
MEETINGS OF STOCKHOLDERS
Section 1.
Place of Meetings
. Meetings of the stockholders for the election of directors or for any other purpose shall be held at such time and place, either within or without the State of Delaware, as shall be designated from time to time by the Board of Directors.
Section 2.
Annual Meetings
. The Annual Meeting of Stockholders for the election of directors shall be held on such date and at such time as shall be designated from time to time by the Board of Directors. Any other proper business may be transacted at the Annual Meeting of Stockholders.
Section 3.
Special Meetings
. Unless otherwise required by law or by the certificate of incorporation of the Corporation, as amended and restated from time to time (the “Certificate of Incorporation”), Special Meetings of Stockholders, for any purpose or purposes, may be called by either
(a)
the Chairman of the Board of Directors, if there be one, (b) the President, (c) any Vice President, if there be one, (d) the Secretary or (e) any Assistant Secretary, if there be one, and shall be called by any such officer at the request in writing of (i) the Board of Directors, (ii) a committee of the Board of Directors that has been duly designated by the Board of Directors and whose powers and authority include the power to call such meetings or (iii) stockholders owning a majority of the capital stock of the Corporation issued and outstanding and entitled to vote. Such request shall state the purpose or purposes of the proposed meeting. At a Special Meeting of Stockholders, only such business shall be conducted as shall be specified in the notice of meeting (or any supplement thereto).
Section 4.
Notice
. Whenever stockholders are required or permitted to take any action at a meeting, a written notice of the meeting shall be given which shall state the place, date and hour of the meeting, and, in the case of a Special Meeting, the purpose or purposes for which the meeting is called. Unless otherwise required by law, written notice of any meeting shall be given not less than ten (10) nor more than sixty (60) days before the date of the meeting to each stockholder entitled to notice of and to vote at such meeting.
Section 5.
Adjournments
. Any meeting of the stockholders may be adjourned from time to time to reconvene at the same or some other place, and notice need not be given of any such adjourned
meeting if the time and place thereof are announced at the meeting at which the adjournment is taken. At the adjourned meeting, the Corporation may transact any business which might have been transacted at the original meeting. If the adjournment is for more than thirty (30) days, or if after the adjournment a new record date is fixed for the adjourned meeting, notice of the adjourned meeting in accordance with the requirements of
Section 4
of this
Article II
shall be given to each stockholder of record entitled to notice of and to vote at the meeting.
Section 6.
Quorum
. Unless otherwise required by applicable law or the Certificate of Incorporation, the holders of a majority of the Corporation’s capital stock issued and outstanding and entitled to vote thereat, present in person or represented by proxy, shall constitute a quorum at all meetings of the stockholders for the transaction of business. A quorum, once established, shall not be broken by the withdrawal of enough votes to leave less than a quorum. If, however, such quorum shall not be present or represented at any meeting of the stockholders, the stockholders entitled to vote thereat, present in person or represented by proxy, shall have power to adjourn the meeting from time to time, in the manner provided in
Section 5
of this
Article II
, until a quorum shall be present or represented.
Section 7.
Voting
. Unless otherwise required by law, the Stockholders Agreement, by and among the Corporation and the stockholders party thereto (as amended, modified or supplemented, the “Stockholders Agreement”), the Certificate of Incorporation or these Bylaws, any question brought before any meeting of the stockholders, other than the election of directors, shall be decided by the vote of the holders of a majority of the total number of votes of the Corporation’s capital stock represented at the meeting and entitled to vote on such question, voting as a single class. Unless otherwise provided in the Certificate of Incorporation, and subject to
Section 11(a)
of this
Article II
, each stockholder represented at a meeting of the stockholders shall be entitled to cast one (1) vote for each share of the capital stock entitled to vote thereat held by such stockholder. Such votes may be cast in person or by proxy as provided in
Section 8
of this
Article II
. The Board of Directors, in its discretion, or the officer of the Corporation presiding at a meeting of the stockholders, in such officer’s discretion, may require that any votes cast at such meeting shall be cast by written ballot.
Section 8.
Proxies
. Each stockholder entitled to vote at a meeting of the stockholders or to express consent or dissent to corporate action in writing without a meeting may authorize another person or persons to act for such stockholder as proxy, but no such proxy shall be voted upon after three (3) years from its date, unless such proxy provides for a longer period. Without limiting the manner in which a stockholder may authorize another person or persons to act for such stockholder as proxy, the following shall constitute a valid means by which a stockholder may grant such authority:
(i)
A stockholder may execute a writing authorizing another person or persons to act for such stockholder as proxy. Execution may be accomplished by the stockholder or such stockholder’s authorized officer, director, employee or agent signing such writing or causing such person’s signature to be affixed to such writing by any reasonable means, including, but not limited to, by facsimile signature.
(ii)
A stockholder may authorize another person or persons to act for such stockholder as proxy by transmitting or authorizing the transmission of a facsimile to the person who will be the holder of the proxy or to a proxy solicitation firm, proxy support service organization or like agent duly authorized by the person who will be the holder of the proxy to receive such facsimile, provided that any such facsimile must either set forth or be submitted with information from which it can be determined that the facsimile was authorized by the stockholder. If it is determined that such facsimiles are valid, the inspectors or, if there are no inspectors, such other persons making that determination shall specify the information on which they relied.
Any copy, facsimile telecommunication or other reliable reproduction of the writing authorizing another person or persons to act as proxy for a stockholder may be substituted or used in lieu of the original writing, facsimile for any and all purposes for which the original writing, facsimile could be used;
provided
, that such copy, facsimile telecommunication or other reproduction shall be a complete reproduction of the entire original writing or facsimile telecommunication.
Section 9.
Consent of Stockholders in Lieu of Meeting
. Unless otherwise provided in the Certificate of Incorporation, any action required or permitted to be taken at any Annual or Special Meeting of Stockholders of the Corporation may be taken without a meeting, without prior notice and without a vote, if a consent or consents in writing, setting forth the action so taken, shall be signed by the holders of outstanding stock having not less than the minimum number of votes that would be necessary to authorize or take such action at a meeting at which all shares entitled to vote thereon were present and voted and shall be delivered to the Corporation by delivery to its registered office in the State of Delaware, its principal place of business, or an officer or agent of the Corporation having custody of the book in which proceedings of meetings of the stockholders are recorded. Delivery made to the Corporation’s registered office shall be by hand or by certified or registered mail, return receipt requested. Every written consent shall bear the date of signature of each stockholder who signs the consent and no written consent shall be effective to take the corporate action referred to therein unless, within sixty (60) days of the earliest dated consent delivered in the manner required by this
Section 9
to the Corporation, written consents signed by a sufficient number of holders to take action are delivered to the Corporation by delivery to its registered office in the State of Delaware, its principal place of business, or an officer or agent of the Corporation having custody of the book in which proceedings of meetings of the stockholders are recorded. Any copy, facsimile or other reliable reproduction of a consent in writing may be substituted or used in lieu of the original writing for any and all purposes for which the original writing could be used, provided that such copy, facsimile or other reproduction shall be a complete reproduction of the entire original writing. Prompt notice of the taking of the corporate action without a meeting by less than unanimous written consent shall be given to those stockholders who have not consented in writing and who, if the action had been taken at a meeting, would have been entitled to notice of the meeting if the record date for such meeting had been the date that written consents signed by a sufficient number of holders to take the action were delivered to the Corporation as provided above in this
Section
9
.
Section 10.
List of Stockholders Entitled to Vote
. The officer of the Corporation who has charge of the stock ledger of the Corporation shall prepare and make, at least ten (10) days before every meeting of the stockholders, a complete list of the stockholders entitled to vote at the meeting, arranged in alphabetical order, and showing the address of each stockholder and the number of shares registered in the name of each stockholder. Such list shall be open to the examination of any stockholder, for any purpose germane to the meeting, during ordinary business hours, for a period of at least ten (10) days prior to the meeting (a) either at a place within the city where the meeting is to be held, which place shall be specified in the notice of the meeting, or, if not so specified, at the place where the meeting is to be held or (b) during ordinary business hours, at the principal place of business of the Corporation. The list shall also be produced and kept at the time and place of the meeting during the whole time thereof, and may be inspected by any stockholder who is present.
Section 11.
Record Date
.
(a)
In order that the Corporation may determine the stockholders entitled to notice of or to vote at any meeting of the stockholders or any adjournment thereof, the Board of Directors may fix a record date, which record date shall not precede the date upon which the resolution fixing the record date is adopted by the Board of Directors, and which record date shall not be more than sixty (60) nor less than ten (10) days before the date of such meeting. If no record date is fixed by the Board of Directors, the
record date for determining stockholders entitled to notice of or to vote at a meeting of the stockholders shall be at the close of business on the day next preceding the day on which notice is given, or, if notice is waived, at the close of business on the day next preceding the day on which the meeting is held. A determination of stockholders of record entitled to notice of or to vote at a meeting of the stockholders shall apply to any adjournment of the meeting;
provided
, that the Board of Directors may fix a new record date for the adjourned meeting.
(b)
In order that the Corporation may determine the stockholders entitled to consent to corporate action in writing without a meeting, the Board of Directors may fix a record date, which record date shall not precede the date upon which the resolution fixing the record date is adopted by the Board of Directors, and which record date shall not be more than ten (10) days after the date upon which the resolution fixing the record date is adopted by the Board of Directors. If no record date has been fixed by the Board of Directors, the record date for determining stockholders entitled to consent to corporate action in writing without a meeting, when no prior action by the Board of Directors is required by applicable law, shall be the first date on which a signed written consent setting forth the action taken or proposed to be taken is delivered to the Corporation by delivery to its registered office in the State of Delaware, its principal place of business, or an officer or agent of the Corporation having custody of the book in which proceedings of meetings of the stockholders are recorded. Delivery made to the Corporation’s registered office shall be by hand or by certified or registered mail, return receipt requested. If no record date has been fixed by the Board of Directors and prior action by the Board of Directors is required by applicable law, the record date for determining stockholders entitled to consent to corporate action in writing without a meeting shall be at the close of business on the day on which the Board of Directors adopts the resolution taking such prior action.
Section 12.
Stock Ledger
. The stock ledger of the Corporation shall be the only evidence as to who are the stockholders entitled to examine the stock ledger, the list required by
Section 10
of this
Article II
or the books of the Corporation, or to vote in person or by proxy at any meeting of the stockholders.
Section 13.
Conduct of Meetings
. The Board of Directors may adopt by resolution such rules and regulations for the conduct of any meeting of the stockholders as it shall deem appropriate. Except to the extent inconsistent with such rules and regulations as adopted by the Board of Directors, the chairman of any meeting of the stockholders shall have the right and authority to prescribe such rules, regulations and procedures and to do all such acts as, in the judgment of such chairman, are appropriate for the proper conduct of the meeting. Such rules, regulations or procedures, whether adopted by the Board of Directors or prescribed by the chairman of the meeting, may include, without limitation, the following: (a) the establishment of an agenda or order of business for the meeting; (b) the determination of when the polls shall open and close for any given matter to be voted on at the meeting; (c) rules and procedures for maintaining order at the meeting and the safety of those present; (d) limitations on attendance at or participation in the meeting to stockholders of record of the Corporation, their duly authorized and constituted proxies or such other persons as the chairman of the meeting shall determine; (e) restrictions on entry to the meeting after the time fixed for the commencement thereof; and (f) limitations on the time allotted to questions or comments by participants.
ARTICLE III
DIRECTORS
Section 1.
Number and Election of Directors
. Unless otherwise required by the Stockholders Agreement, the Board of Directors shall consist of not less than one nor more than fifteen members, the exact number of which shall initially be fixed by the Incorporator and thereafter from time to time by the Board of Directors. Except as provided in
Section 2
of this
Article III
, directors shall be elected by a majority of the votes cast at each Annual Meeting of Stockholders and each director so elected shall hold office until the next Annual Meeting of Stockholders and until such director’s successor is duly elected and qualified, or until such director’s earlier death, resignation or removal. Directors need not be stockholders.
Section 2.
Vacancies
. Unless otherwise required by law, the Stockholders Agreement or the Certificate of Incorporation, vacancies on the Board of Directors or any committee thereof arising through death, resignation, removal, an increase in the number of directors constituting the Board of Directors or such committee or otherwise may be filled only by a majority of the directors then in office, though less than a quorum, or by a sole remaining director. The directors so chosen shall, in the case of the Board of Directors, hold office until the next annual election and until their successors are duly elected and qualified, or until their earlier death, resignation or removal and, in the case of any committee of the Board of Directors, shall hold office until their successors are duly appointed by the Board of Directors or until their earlier death, resignation or removal.
Section 3.
Duties and Powers
. The business and affairs of the Corporation shall be managed by or under the direction of the Board of Directors which may exercise all such powers of the Corporation and do all such lawful acts and things as are not by statute or by the Certificate of Incorporation or by these Bylaws required to be exercised or done by the stockholders.
Section 4.
Meetings
. The Board of Directors and any committee thereof may hold meetings, both regular and special, either within or without the State of Delaware. Regular meetings of the Board of Directors or any committee thereof may be held without notice at such time and at such place as may from time to time be determined by the Board of Directors or such committee, respectively. Special meetings of the Board of Directors may be called by the Chairman of the Board of Directors, if there be one, the President, or by any director. Special meetings of any committee of the Board of Directors may be called by the chairman of such committee, if there be one, the President, or any director serving on such committee. Notice thereof stating the place, date and hour of the meeting shall be given to each director (or, in the case of a committee, to each member of such committee) either by mail not less than forty-eight (48) hours before the date of the meeting, by telephone or facsimile on twenty-four (24) hours’ notice, or on such shorter notice as the person or persons calling such meeting may deem necessary or appropriate in the circumstances.
Section 5.
Organization
. At each meeting of the Board of Directors or any committee thereof, the Chairman of the Board of Directors or the chairman of such committee, as the case may be, or, in his or her absence or if there be none, a director chosen by a majority of the directors present, shall act as chairman. Except as provided below, the Secretary of the Corporation shall act as secretary at each meeting of the Board of Directors and of each committee thereof. In case the Secretary shall be absent from any meeting of the Board of Directors or of any committee thereof, an Assistant Secretary shall perform the duties of secretary at such meeting; and in the absence from any such meeting of the Secretary and all the Assistant Secretaries, the chairman of the meeting may appoint any person to act as secretary of the meeting. Notwithstanding the foregoing, the members of each committee of the Board of Directors may appoint any person to act as secretary of any meeting of such committee and the Secretary
or any Assistant Secretary of the Corporation may, but need not if such committee so elects, serve in such capacity.
Section 6.
Resignations and Removals of Directors
. Any director of the Corporation may resign from the Board of Directors or any committee thereof at any time, by giving notice in writing to the Chairman of the Board of Directors, if there be one, the President or the Secretary of the Corporation and, in the case of a committee, to the chairman of such committee, if there be one. Such resignation shall take effect at the time therein specified or, if no time is specified, immediately; and, unless otherwise specified in such notice, the acceptance of such resignation shall not be necessary to make it effective. Except as otherwise required by applicable law or the Stockholders Agreement, (a) any director or the entire Board of Directors may be removed from office at any time by the affirmative vote of the holders of at least a majority in voting power of the issued and outstanding capital stock of the Corporation entitled to vote in the election of directors, and (b) any director serving on a committee of the Board of Directors may be removed from such committee at any time by the Board of Directors.
Section 7.
Quorum
. Except as otherwise required by law, the Certificate of Incorporation or the Stockholders Agreement, at all meetings of the Board of Directors or any committee thereof, a majority of the entire Board of Directors or a majority of the directors constituting such committee, as the case may be, shall constitute a quorum for the transaction of business and the act of a majority of the directors or committee members present at any meeting at which there is a quorum shall be the act of the Board of Directors or such committee, as applicable. If a quorum shall not be present at any meeting of the Board of Directors or any committee thereof, the directors present thereat may adjourn the meeting from time to time, without notice other than announcement at the meeting of the time and place of the adjourned meeting, until a quorum shall be present.
Section 8.
Actions of the Board by Written Consent
. Unless otherwise provided in the Certificate of Incorporation or these Bylaws, any action required or permitted to be taken at any meeting of the Board of Directors or of any committee thereof may be taken without a meeting, if all the members of the Board of Directors or such committee, as the case may be, consent thereto in writing, and the writing or writings are filed with the minutes of proceedings of the Board of Directors or such committee. Any copy, facsimile or other reliable reproduction of a consent in writing may be substituted or used in lieu of the original writing for any and all purposes for which the original writing could be used, provided that such copy, facsimile or other reproduction shall be a complete reproduction of the entire original writing.
Section 9.
Meetings by Means of Conference Telephone
. Unless otherwise provided in the Certificate of Incorporation or these Bylaws, members of the Board of Directors, or any committee thereof, may participate in a meeting of the Board of Directors or such committee by means of a conference telephone or other communications equipment by means of which all persons participating in the meeting can hear each other, and participation in a meeting pursuant to this
Section 9
shall constitute presence in person at such meeting.
Section 10.
Committees
. Unless otherwise required by the Stockholders Agreement, (a) the Board of Directors may designate one or more committees, each committee to consist of one or more of the directors of the Corporation, (b) the Board of Directors may designate one or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of any such committee, and (c) in the absence or disqualification of a member of a committee, and in the absence of a designation by the Board of Directors of an alternate member to replace the absent or disqualified member, the member or members thereof present at any meeting and not disqualified from voting, whether or not such member or members constitute a quorum, may unanimously appoint another
qualified member of the Board of Directors to act at the meeting in the place of any absent or disqualified member. Any committee, to the extent permitted by law and provided in the resolution establishing such committee, shall have and may exercise all the powers and authority of the Board of Directors in the management of the business and affairs of the Corporation, and may authorize the seal of the Corporation to be affixed to all papers which may require it. Each committee shall keep regular minutes and report to the Board of Directors when required. Notwithstanding anything to the contrary contained in this
Article
III
, the resolution of the Board of Directors establishing any committee of the Board of Directors and/or the charter of any such committee may establish requirements or procedures relating to the governance and/or operation of such committee that are different from, or in addition to, those set forth in these Bylaws and, to the extent that there is any inconsistency between these Bylaws and any such resolution or charter, the terms of such resolution or charter shall be controlling.
Section 11.
Compensation
. The directors may be paid their expenses, if any, of attendance at each meeting of the Board of Directors and may be paid a fixed sum for attendance at each meeting of the Board of Directors or a stated salary for service as director, payable in cash or securities. No such payment shall preclude any director from serving the Corporation in any other capacity and receiving compensation therefor. Members of special or standing committees may be allowed like compensation for service as committee members.
Section 12.
Interested Directors
. No contract or transaction between the Corporation and one or more of its directors or officers, or between the Corporation and any other corporation, partnership, association or other organization in which one or more of its directors or officers are directors or officers or have a financial interest, shall be void or voidable solely for this reason, or solely because the director or officer is present at or participates in the meeting of the Board of Directors or committee thereof which authorizes the contract or transaction, or solely because any such director’s or officer’s vote is counted for such purpose if: (a) the material facts as to the director’s or officer’s relationship or interest and as to the contract or transaction are disclosed or are known to the Board of Directors or the committee, and the Board of Directors or committee in good faith authorizes the contract or transaction by the affirmative votes of a majority of the disinterested directors, even though the disinterested directors be less than a quorum; (b) the material facts as to the director’s or officer’s relationship or interest and as to the contract or transaction are disclosed or are known to the stockholders entitled to vote thereon, and the contract or transaction is specifically approved in good faith by vote of the stockholders; or (c) the contract or transaction is fair as to the Corporation as of the time it is authorized, approved or ratified by the Board of Directors, a committee thereof or the stockholders. Common or interested directors may be counted in determining the presence of a quorum at a meeting of the Board of Directors or of a committee which authorizes the contract or transaction.
ARTICLE IV
OFFICERS
Section 1.
General
. The officers of the Corporation shall be chosen by the Board of Directors and shall be a President, a Secretary and a Treasurer. Any one or more individuals may hold such offices. The Board of Directors, in its discretion, also may choose a Chairman of the Board of Directors (who must be a director) and one or more Vice Presidents, Assistant Secretaries, Assistant Treasurers and other officers. Any number of offices may be held by the same person, unless otherwise prohibited by law, the Certificate of Incorporation or these Bylaws. The officers of the Corporation need not be stockholders of the Corporation nor, except in the case of the Chairman of the Board of Directors, need such officers be directors of the Corporation.
Section 2.
Election
. The Board of Directors, at its first meeting held after each Annual Meeting of Stockholders (or action by written consent of stockholders in lieu of the Annual Meeting of Stockholders), shall elect the officers of the Corporation who shall hold their offices for such terms and shall exercise such powers and perform such duties as shall be determined from time to time by the Board of Directors; and each officer of the Corporation shall hold office until such officer’s successor is elected and qualified, or until such officer’s earlier death, resignation or removal. Any officer elected by the Board of Directors (including, without limitation, the Chairman of the Board of Directors) may be removed at any time by the Board of Directors. Except as provided in
Section 4
of this
Article IV
with regard to the Chairman of the Board of Directors, any vacancy occurring in any office of the Corporation shall be filled by the Board of Directors. The salaries of all officers of the Corporation shall be fixed by the Board of Directors.
Section 3.
Voting Securities Owned by the Corporation
. Powers of attorney, proxies, waivers of notice of meeting, consents and other instruments relating to securities owned by the Corporation may be executed in the name of and on behalf of the Corporation by the President or any Vice President or any other officer authorized to do so by the Board of Directors and any such officer may, in the name of and on behalf of the Corporation, take all such action as any such officer may deem advisable to vote in person or by proxy at any meeting of security holders of any corporation in which the Corporation may own securities and at any such meeting shall possess and may exercise any and all rights and power incident to the ownership of such securities and which, as the owner thereof, the Corporation might have exercised and possessed if present. The Board of Directors may, by resolution, from time to time confer like powers upon any other person or persons.
Section 4.
Chairman of the Board of Directors
. The Chairman of the Board of Directors, if there be one, shall preside at all meetings of the stockholders and of the Board of Directors. Unless otherwise required by the Stockholders Agreement, the Chairman of the Board of Directors shall be designated by a majority of the Board of Directors and, except where by law the signature of the President is required, the Chairman of the Board of Directors shall possess the same power as the President to sign all contracts, certificates and other instruments of the Corporation which may be authorized by the Board of Directors. During the absence or disability of the President, the Chairman of the Board of Directors shall exercise all the powers and discharge all the duties of the President. The Chairman of the Board of Directors shall also perform such other duties and may exercise such other powers as may from time to time be assigned by these Bylaws or by the Board of Directors.
Section 5.
President
. The President shall, subject to the control of the Board of Directors and, if there be one, the Chairman of the Board of Directors, have general supervision of the business of the Corporation and shall see that all orders and resolutions of the Board of Directors are carried into effect. The President shall execute all bonds, mortgages, contracts and other instruments of the
Corporation requiring a seal, under the seal of the Corporation, except where required or permitted by law to be otherwise signed and executed and except that the other officers of the Corporation may sign and execute documents when so authorized by these Bylaws, the Board of Directors or the President. In the absence or disability of the Chairman of the Board of Directors, or if there be none, the President shall preside at all meetings of the stockholders and, provided the President is also a director, the Board of Directors. Unless the Board of Directors designates otherwise, the President shall be the Chief Executive Officer of the Corporation. The President shall also perform such other duties and may exercise such other powers as may from time to time be assigned to such officer by these Bylaws or by the Board of Directors.
Section 6.
Vice Presidents
. At the request of the President or in the President’s absence or in the event of the President’s inability or refusal to act (and if there be no Chairman of the Board of Directors), the Vice President, or the Vice Presidents if there is more than one (in the order designated by the Board of Directors), shall perform the duties of the President, and when so acting, shall have all the powers of and be subject to all the restrictions upon the President. Each Vice President shall perform such other duties and have such other powers as the Board of Directors from time to time may prescribe. If there be no Chairman of the Board of Directors and no Vice President, the Board of Directors shall designate the officer of the Corporation who, in the absence of the President or in the event of the inability or refusal of the President to act, shall perform the duties of the President, and when so acting, shall have all the powers of and be subject to all the restrictions upon the President.
Section 7.
Secretary
. The Secretary shall attend all meetings of the Board of Directors and all meetings of the stockholders and record all the proceedings thereat in a book or books to be kept for that purpose; the Secretary shall also perform like duties for committees of the Board of Directors when required. The Secretary shall give, or cause to be given, notice of all meetings of the stockholders and special meetings of the Board of Directors, and shall perform such other duties as may be prescribed by the Board of Directors, the Chairman of the Board of Directors or the President, under whose supervision the Secretary shall be. If the Secretary shall be unable or shall refuse to cause to be given notice of all meetings of the stockholders and special meetings of the Board of Directors, and if there be no Assistant Secretary, then either the Board of Directors or the President may choose another officer to cause such notice to be given. The Secretary shall have custody of the seal of the Corporation and the Secretary or any Assistant Secretary, if there be one, shall have authority to affix the same to any instrument requiring it and when so affixed, it may be attested by the signature of the Secretary or by the signature of any such Assistant Secretary. The Board of Directors may give general authority to any other officer to affix the seal of the Corporation and to attest to the affixing by such officer’s signature. The Secretary shall see that all books, reports, statements, certificates and other documents and records required by law to be kept or filed are properly kept or filed, as the case may be.
Section 8.
Treasurer
. The Treasurer shall have the custody of the corporate funds and securities and shall keep full and accurate accounts of receipts and disbursements in books belonging to the Corporation and shall deposit all moneys and other valuable effects in the name and to the credit of the Corporation in such depositories as may be designated by the Board of Directors. The Treasurer shall disburse the funds of the Corporation as may be ordered by the Board of Directors, taking proper vouchers for such disbursements, and shall render to the President and the Board of Directors, at its regular meetings, or when the Board of Directors so requires, an account of all transactions as Treasurer and of the financial condition of the Corporation. If required by the Board of Directors, the Treasurer shall give the Corporation a bond in such sum and with such surety or sureties as shall be satisfactory to the Board of Directors for the faithful performance of the duties of the office of the Treasurer and for the restoration to the Corporation, in case of the Treasurer’s death, resignation, retirement or removal from
office, of all books, papers, vouchers, money and other property of whatever kind in the Treasurer’s possession or under the Treasurer’s control belonging to the Corporation.
Section 9.
Assistant Secretaries
. Assistant Secretaries, if there be any, shall perform such duties and have such powers as from time to time may be assigned to them by the Board of Directors, the President, any Vice President, if there be one, or the Secretary, and in the absence of the Secretary or in the event of the Secretary’s inability or refusal to act, shall perform the duties of the Secretary, and when so acting, shall have all the powers of and be subject to all the restrictions upon the Secretary.
Section 10.
Assistant Treasurers
. Assistant Treasurers, if there be any, shall perform such duties and have such powers as from time to time may be assigned to them by the Board of Directors, the President, any Vice President, if there be one, or the Treasurer, and in the absence of the Treasurer or in the event of the Treasurer’s inability or refusal to act, shall perform the duties of the Treasurer, and when so acting, shall have all the powers of and be subject to all the restrictions upon the Treasurer. If required by the Board of Directors, an Assistant Treasurer shall give the Corporation a bond in such sum and with such surety or sureties as shall be satisfactory to the Board of Directors for the faithful performance of the duties of the office of Assistant Treasurer and for the restoration to the Corporation, in case of the Assistant Treasurer’s death, resignation, retirement or removal from office, of all books, papers, vouchers, money and other property of whatever kind in the Assistant Treasurer’s possession or under the Assistant Treasurer’s control belonging to the Corporation.
Section 11.
Other Officers
. Such other officers as the Board of Directors may choose shall perform such duties and have such powers as from time to time may be assigned to them by the Board of Directors. The Board of Directors may delegate to any other officer of the Corporation the power to choose such other officers and to prescribe their respective duties and powers.
ARTICLE V
STOCK
Section 1.
Form of Certificates
. The Corporation may issue some or all of the shares of any or all of the Corporation’s classes or series of Stock without certificates if authorized by the Board of Directors. In the event that the Corporation issues shares of stock represented by certificates, such certificates shall be in such form as prescribed by the Board of Directors or a duly authorized officer, shall contain the statements and information required by the General Corporation Law of the State of Delaware (the
“
DGCL”) and shall be signed by the officers of the Corporation in the manner permitted by the DGCL. In the event that the Corporation issues shares of stock without certificates, to the extent then required by the DGCL, the Corporation shall provide to the record holders of such shares a written statement of the information required by the DGCL to be included on stock certificates. There shall be no differences in the rights and obligations of stockholders based on whether or not their shares are represented by certificates. If a class or series of stock is authorized by the Board of Directors to be issued without certificates, no stockholder shall be entitled to a certificate of certificates representing any shares of such class or series of stock held by such stockholder unless otherwise determined by the Board of Directors and then only upon written request by such stockholder to the Secretary.
Section 2.
Signatures
. Any or all of the signatures on a certificate may be a facsimile. In case any officer, transfer agent or registrar who has signed or whose facsimile signature has been placed upon a certificate shall have ceased to be such officer, transfer agent or registrar before such certificate is issued, it may be issued by the Corporation with the same effect as if such person were such officer, transfer agent or registrar at the date of issue.
Section 3.
Lost Certificates
. The Board of Directors may direct a new certificate to be issued in place of any certificate theretofore issued by the Corporation alleged to have been lost, stolen or destroyed, upon the making of an affidavit of that fact by the person claiming the certificate of stock to be lost, stolen or destroyed;
provided
, that if such shares have ceased to be certificated no new certificate shall be issued unless requested in writing by such stockholder and the Board of Directors has determined that such certificates may be issued. When authorizing such issuance of a new certificate, the Board of Directors may, in its discretion and as a condition precedent to the issuance thereof, require the owner of such lost, stolen or destroyed certificate, or such owner’s legal representative, to advertise the same in such manner as the Board of Directors shall require and/or to give the Corporation a bond in such sum as it may direct as indemnity against any claim that may be made against the Corporation on account of the alleged loss, theft or destruction of such certificate or the issuance of such new certificate.
Section 4.
Transfers
. Stock of the Corporation shall be transferable in the manner prescribed by applicable law, the Stockholders Agreement and in these Bylaws. Transfers of stock shall be made on the books of the Corporation only by the record holder of the shares or by such person’s attorney lawfully constituted in writing and, if such shares are certificated, upon the surrender of the certificate therefor, properly endorsed for transfer and payment of all necessary transfer taxes;
provided
, that such surrender and endorsement or payment of taxes shall not be required in any case in which the officers of the Corporation shall determine to waive such requirement. Every certificate exchanged, returned or surrendered to the Corporation shall be marked “Cancelled,” with the date of cancellation, by the Secretary or Assistant Secretary of the Corporation or the transfer agent thereof. No transfer of stock shall be valid as against the Corporation for any purpose until it shall have been entered in the stock records of the Corporation by an entry showing from and to whom transferred.
Section 5.
Dividend Record Date
. Except as otherwise set forth in the Certificate of Incorporation, in order that the Corporation may determine 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 of Directors may fix a record date, which record date shall not precede the date upon which the resolution fixing the record date is adopted, and which record date shall be not more than sixty (60) days prior to such action. If no record date is fixed, the record date for determining stockholders for any such purpose shall be at the close of business on the day on which the Board of Directors adopts the resolution relating thereto.
Section 6.
Record Owners
. The Corporation 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 to hold liable for calls and assessments a person registered on its books as the owner of shares, 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 7.
Transfer and Registry Agents
. The Corporation may from time to time maintain one or more transfer offices or agencies and registry offices or agencies at such place or places as may be determined from time to time by the Board of Directors.
ARTICLE VI
NOTICES
Section 1.
Notices
. Whenever written notice is required by law, the Certificate of Incorporation or these Bylaws, to be given to any director, member of a committee or stockholder, such notice may be given by mail, addressed to such director, member of a committee or stockholder, at such person’s address as it appears on the records of the Corporation, with postage thereon prepaid, and such notice shall be deemed to be given at the time when the same shall be deposited in the United States mail. Written notice may also be given personally or by facsimile, telegram, telex or cable.
Section 2.
Waivers of Notice
. Whenever any notice is required by applicable law, the Certificate of Incorporation or these Bylaws, to be given to any director, member of a committee or stockholder, a waiver thereof in writing, signed by the person or persons entitled to notice, whether before or after the time stated therein, shall be deemed equivalent thereto. Attendance of a person at a meeting, present in person or represented by proxy, shall constitute a waiver of notice of such meeting, except where the person attends the meeting for the express purpose of objecting at the beginning of the meeting to the transaction of any business because the meeting is not lawfully called or convened. Neither the business to be transacted at, nor the purpose of, any Annual or Special Meeting of Stockholders or any regular or special meeting of the directors or members of a committee of directors need be specified in any written waiver of notice unless so required by law, the Certificate of Incorporation or these Bylaws.
ARTICLE VII
GENERAL PROVISIONS
Section 1.
Dividends
. Dividends upon the capital stock of the Corporation, subject to the requirements of the DGCL and the provisions of the Certificate of Incorporation, if any, may be declared by the Board of Directors at any regular or special meeting of the Board of Directors (or any action by written consent in lieu thereof in accordance with
Section 8
of
Article III
hereof), and may be paid in cash, in property, or in shares of the Corporation’s capital stock. Before payment of any dividend, there may be set aside out of any funds of the Corporation available for dividends such sum or sums as the Board of Directors from time to time, in its absolute discretion, deems proper as a reserve or reserves to meet contingencies, or for purchasing any of the shares of capital stock, warrants, rights, options, bonds, debentures, notes, scrip or other securities or evidences of indebtedness of the Corporation, or for equalizing dividends, or for repairing or maintaining any property of the Corporation, or for any proper purpose, and the Board of Directors may modify or abolish any such reserve.
Section 2.
Disbursements
. All checks or demands for money and notes of the Corporation shall be signed by such officer or officers or such other person or persons as the Board of Directors may from time to time designate.
Section 3.
Fiscal Year
. The fiscal year of the Corporation shall be fixed by resolution of the Board of Directors.
Section 4.
Corporate Seal
. The Board of Directors may authorize the adoption of a seal by the Corporation. Any such seal shall contain the name of the Corporation and the year of its incorporation and the words “Corporate Seal, Delaware.” The Board of Directors may authorize one or more duplicate seals and provide for the custody thereof. The seal may be used by causing it or a facsimile thereof to be impressed or affixed or reproduced or otherwise.
Section 5.
Affixing Seal
. Whenever the Corporation is permitted or required to affix its seal to a document, it shall be sufficient to meet the requirements of any law, rule or regulation relating to a seal to place the word “(SEAL)” adjacent to the signature of the person authorized to execute the document on behalf of the Corporation.
ARTICLE VIII
INDEMNIFICATION
Section 1.
Power to Indemnify in Actions, Suits or Proceedings other than Those by or in
the Right of the Corporation
. Subject to
Section 3
of this
Article VIII
, the Corporation shall indemnify, to the fullest extent permitted by applicable law, 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 or officer of the Corporation, or is or was a director or officer of the Corporation 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 such person in connection with such action, suit or proceeding if such person acted in good faith and in a manner such 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 such person’s conduct was unlawful. The termination of any action, suit or proceeding by judgment, order, settlement, conviction, or upon a plea of nolo contendere or its equivalent, shall not, of itself, create a presumption that the person did not act in good faith and in a manner which such 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 reasonable cause to believe that such person’s conduct was unlawful.
Section 2.
Power to Indemnify in Actions, Suits or Proceedings by or in the Right of the
Corporation
. Subject to
Section 3
of this
Article VIII
, the Corporation shall indemnify, to the fullest extent permitted by applicable law, 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 is or was a director or officer of the Corporation, or is or was a director or officer of the Corporation 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) actually and reasonably incurred by such person in connection with the defense or settlement of such action or suit if such person acted in good faith and in a manner such 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 of the State of Delaware or the court in which such action or suit was brought shall determine upon application that, despite the adjudication of liability but in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which the Court of Chancery or such other court shall deem proper.
Section 3.
Authorization of Indemnification
. Any indemnification under this
Article VIII
(unless ordered by a court) shall be made by the Corporation only as authorized in the specific case upon a determination that indemnification of the present or former director or officer is proper in the circumstances because such person has met the applicable standard of conduct set forth in
Section 1
or
Section 2
of this
Article VIII
, as the case may be. Such determination shall be made, with respect to a person who is a director or officer at the time of such determination, (a) by a majority vote of the directors who are not parties to such action, suit or proceeding, even though less than a quorum, (b) by a committee of such directors designated by a majority vote of such directors, even though less than a quorum, (c) if there are no such directors, or if such directors so direct, by independent legal counsel in a written opinion or (d) by the stockholders. Such determination shall be made, with respect to former directors and officers, by any person or persons having the authority to act on the matter on behalf of the Corporation. To the extent, however, that a present or former director or officer of the Corporation has been successful
on the merits or otherwise in defense of any action, suit or proceeding described above, or in 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, without the necessity of authorization in the specific case.
Section 4.
Good Faith Defined
. For purposes of any determination under
Section 3
of this
Article VIII
, a person shall be deemed to have acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the Corporation, or, with respect to any criminal action or proceeding, to have had no reasonable cause to believe such person’s conduct was unlawful, if such person’s action is based on the records or books of account of the Corporation or another enterprise, or on information supplied to such person by the officers of the Corporation or another enterprise in the course of their duties, or on the advice of legal counsel for the Corporation or another enterprise or on information or records given or reports made to the Corporation or another enterprise by an independent certified public accountant or by an appraiser or other expert selected with reasonable care by the Corporation or another enterprise. The provisions of this
Section 4
shall not be deemed to be exclusive or to limit in any way the circumstances in which a person may be deemed to have met the applicable standard of conduct set forth in
Section 1
or
Section 2
of this
Article VIII
, as the case may be.
Section 5.
Indemnification by a Court
. Notwithstanding any contrary determination in the specific case under
Section 3
of this
Article VIII
, and notwithstanding the absence of any determination thereunder, any director or officer may apply to the Court of Chancery of the State of Delaware or any other court of competent jurisdiction in the State of Delaware for indemnification to the extent otherwise permissible under
Section 1
or
Section 2
of this
Article VIII
or for advancement of expenses to the extent otherwise permissible under
Section 6
of this
Article VIII
. The basis of such indemnification by a court shall be a determination by such court that indemnification of the director or officer is proper in the circumstances because such person has met the applicable standard of conduct set forth in
Section 1
or
Section 2
of this
Article VIII
, as the case may be. Neither a contrary determination in the specific case under
Section 3
of this
Article VIII
nor the absence of any determination thereunder shall be a defense to such application or create a presumption that the director or officer seeking indemnification has not met any applicable standard of conduct. Notice of any application for indemnification or advancement of expenses pursuant to this
Section 5
shall be given to the Corporation promptly upon the filing of such application. If successful, in whole or in part, the director or officer seeking indemnification or advancement of expenses shall also be entitled to be paid the expense of prosecuting such application to the fullest extent permitted by applicable law.
Section 6.
Expenses Payable in Advance
. Expenses (including attorneys’ fees) incurred by a director or officer in defending any civil, criminal, administrative or investigative action, suit or proceeding shall, to the fullest extent not prohibited by applicable law, be paid by the Corporation in advance of the final disposition of such action, suit or proceeding upon receipt of an undertaking by or on behalf of such director or officer to repay such amount if it shall ultimately be determined that such person is not entitled to be indemnified by the Corporation as authorized in this
Article VIII
. Such expenses (including attorneys’ fees) incurred by former directors and officers or other employees and agents may be so paid upon such terms and conditions, if any, as the Corporation deems appropriate.
Section 7.
Nonexclusivity of Indemnification and Advancement o
f Expenses. The indemnification and advancement of expenses provided by, or granted pursuant to, this
Article VIII
shall not be deemed exclusive of any other rights to which those seeking indemnification or advancement of expenses may be entitled under the Certificate of Incorporation, these By-Laws, agreement, vote of stockholders or disinterested directors or otherwise, both as to action in such person’s official capacity
and as to action in another capacity while holding such office, it being the policy of the Corporation that indemnification of the persons specified in
Section 1
and
Section 2
of this
Article VIII
shall be made to the fullest extent permitted by law. The provisions of this
Article VIII
shall not be deemed to preclude the indemnification of any person who is not specified in
Section 1
or
Section 2
of this
Article VIII
but whom the Corporation has the power or obligation to indemnify under the provisions of the DGCL, or otherwise.
Section 8.
Insurance
. The Corporation may purchase and maintain insurance on behalf of any person who is or was a director or officer of the Corporation, or is or was a director or officer of the Corporation 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 person’s status as such, whether or not the Corporation would have the power or the obligation to indemnify such person against such liability under the provisions of this
Article VIII
.
Section 9.
Certain Definitions
. For purposes of this
Article VIII
, references to “the Corporation” shall include, in addition to the resulting corporation, any constituent corporation (including any constituent of a constituent) absorbed in a consolidation or merger which, if its separate existence had continued, would have had power and authority to indemnify its directors or officers, so that any person who is or was a director or officer of such constituent corporation, or is or was a director or officer of such constituent corporation serving at the request of such constituent corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, shall stand in the same position under the provisions of this
Article VIII
with respect to the resulting or surviving corporation as such person would have with respect to such constituent corporation if its separate existence had continued. The term “another enterprise” as used in this
Article VIII
shall mean any other corporation or any partnership, joint venture, trust, employee benefit plan or other enterprise of which such person is or was serving at the request of the Corporation as a director, officer, employee or agent.
For purposes of this
Article VIII
, references to “fines” shall include any excise taxes assessed on a person with respect to an employee benefit plan; and references to “serving at the request of the Corporation” shall include any service as a director, officer, employee or agent of the Corporation which imposes duties on, or involves services by, such director or officer with respect to an employee benefit plan, its participants or beneficiaries; and a person who acted in good faith and in a manner such person reasonably believed to be in the interest of the participants and beneficiaries of an employee benefit plan shall be deemed to have acted in a manner “not opposed to the best interests of the Corporation” as referred to in this
Article VIII
.
Section 10.
Survival of Indemnification and Advancement of Expenses
. The indemnification and advancement of expenses provided by, or granted pursuant to, this
Article VIII
shall, unless otherwise provided when authorized or ratified, continue as to a person who has ceased to be a director or officer and shall inure to the benefit of the heirs, executors and administrators of such a person.
Section 11.
Limitation on Indemnification
. Notwithstanding anything contained in this
Article VIII
to the contrary, except for proceedings to enforce rights to indemnification and to advancement of expenses (which shall be governed by
Section 5
of this
Article VIII
), the Corporation shall not be obligated to indemnify any director or officer (or his or her heirs, executors or personal or legal representatives) or advance expenses in connection with a proceeding (or part thereof) initiated by such person unless such proceeding (or part thereof) was authorized or consented to by the Board of Directors.
Section 12.
Indemnification of Employees and Agents
. The Corporation may, to the extent authorized from time to time by the Board of Directors, provide rights to indemnification and to the advancement of expenses to employees and agents of the Corporation similar to those conferred in this
Article VIII
to directors and officers of the Corporation.
Section 13.
Amendment or Repeal
. Any right to indemnification or to advancement of expenses of any director or officer arising hereunder shall not be eliminated or impaired by an amendment to or repeal of these bylaws after the occurrence of the act or omission that is the subject of the action, suit or proceeding for which indemnification or advancement of expenses is sought.
ARTICLE IX
MISCELLANEOUS
Section 1.
Amendments
. Unless otherwise required by the Certificate of Incorporation or the Stockholders Agreement, these Bylaws may be altered, amended or repealed, in whole or in part, or new Bylaws may be adopted by the stockholders or by the Board of Directors;
provided
, that notice of such alteration, amendment, repeal or adoption of new Bylaws be contained in the notice of such meeting of the stockholders or Board of Directors, as the case may be. All such amendments must be approved by either the holders of a majority of the outstanding capital stock entitled to vote thereon or by a majority of the entire Board of Directors then in office.
Section 2.
Entire Board of Directors
. As used in this
Article IX
and in these Bylaws generally, the term “entire Board of Directors” means the total number of directors which the Corporation would have if there were no vacancies.
Section 3.
Stockholders Agreement
. To the extent there is a conflict between these Bylaws and the Stockholders Agreement, the Stockholders Agreement shall control to the fullest extent permitted by law.
Section 4.
Forum for Adjudication of Disputes
. Unless the Corporation consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of the Corporation, (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of the Corporation to the Corporation or the Corporation’s stockholders, (iii) any action asserting a claim arising pursuant to any provision of the DGCL, or (iv) any action asserting a claim governed by the internal affairs doctrine, in each such case subject to said Court of Chancery having personal jurisdiction over the indispensable parties named as defendants therein. Any person or entity purchasing or otherwise acquiring any interest in shares of capital stock of the Corporation shall be deemed to have notice of and consented to the provisions of this
Section 4
.
*
* *
Adopted as of: December 9, 2011
CERTIFICATE OF AMENDMENT OF
THE BYLAWS
OF
TIGERCAT PHARMA, INC.
The undersigned, Anie K Roche, hereby certifies that:
1.
She is the duly elected and acting Secretary of Tigercat Pharma Inc., a Delaware corporation (the “Corporation”).
2. Effective December 21, 2012, a new Article X of the Bylaws of the Corporation is added to read as follows:
“ARTICLE X
Right of First Refusal
No stockholder shall sell, assign, pledge, or in any manner transfer any of the shares of common stock of the Corporation or any right or interest therein, whether voluntarily or by operation of law, or by gift or otherwise, except by a transfer which meets the requirements hereinafter set forth in this bylaw:
(a)
(i) In the event a stockholder receives from anyone a bona fide offer acceptable to the stockholder to purchase any of his shares of common stock or (ii) in the event of a restricted transfer (as defined below) by a stockholder, such stockholder shall give written notice thereof to the Corporation. The notice shall name the proposed transferee and state the number of shares, right or interest to be transferred, the price per share and all other terms and conditions of the offer or restricted transfer, as applicable. As used herein, “restricted transfer” shall mean: (v) the filing of a petition in bankruptcy by or against a stockholder; (w) an adjudication that a stockholder is an insane or incompetent person; (x) any assignment by a stockholder for the benefit of his, her or its creditors; and (y) any transfer, award, or confirmation of any common stock to a stockholder’s spouse pursuant to a decree of divorce, dissolution, or separate maintenance, or pursuant to a property settlement or separation agreement.
(b)
For thirty (30) days following receipt of such notice, the Corporation or its assigns shall have the option to purchase all or any lesser part of the shares specified in the notice at the price and upon the terms set forth in such bona fide offer; provided, however, that in the event of a restricted transfer, the purchase price per share shall equal the net book value per share of the common stock of the Corporation determined on a fully diluted, fully converted basis as of the last day of the preceding fiscal year, as determined by the independent accountants of the Corporation (or, in the event that the Corporation has not engaged an independent accountant, the Board of Directors of the Corporation) based on their review, but not necessarily an audit, of the Corporation’s financial statements. Net book value shall be calculated using the historical cost of the Corporation’s assets as reflected on its financial statements decreased by any depreciation, amortization or other cost recover method consistently applied for financial accounting purposes. Net book value shall not include any unrealized gain or loss on the Corporation’s assets or the
value, if any, of the Corporation’s goodwill or other assets that are not reflected on the Corporation’s financial statements.
(c)
In the event the Corporation elects to purchase all or any part of the shares, the Secretary of the Corporation shall give written notice to the selling stockholder of such election and the Corporation shall, within thirty (30) days after the Secretary of the Corporation mails such notice, deliver to the selling stockholder the consideration set forth in the selling stockholder’s notice of sale.
(d)
In the event that all of the shares are not purchased by the Corporation, the selling stockholder may, within the sixty (60) day period following the expiration of the option rights granted to the Corporation, sell elsewhere the shares specified in said selling stockholder’s notice which were not acquired by the Corporation in accordance with the provisions of paragraph (e) of this bylaw, provided that said sale shall not be on terms and conditions more favorable to the purchaser than those contained in the bona fide offer set forth in said selling stockholder’s notice. All shares so sold by said selling stockholder shall continue to be subject to the provisions of this bylaw in the same manner as before said transfer.
(e)
Anything to the contrary contained herein notwithstanding, the following transactions shall be exempt from the provisions of this bylaw:
(1)
A stockholder’s transfer of any or all shares held either during such stockholder’s lifetime or on death by will or intestacy to such stockholder’s immediate family. “Immediate family” as used herein shall mean spouse (subject to limitations in the event of a restricted transfer), lineal descendent, father, mother, brother, or sister of the stockholder making such transfer.
(2)
A stockholder’s bona fide pledge or mortgage of any shares of common stock with a commercial lending institution, provided that any subsequent transfer of said shares by said institution shall be conducted in the manner set forth in this bylaw.
(3)
A stockholder’s transfer of any or all of such stockholder’s shares of common stock to any other stockholder of the Corporation.
(4)
A stockholder’s transfer of any or all of such stockholders shares of common stock to a person who, at the time of such transfer, is an officer or director of the Corporation.
(5)
A corporate stockholder’s transfer of any or all of its shares of common stock pursuant to and in accordance with the terms of any merger, consolidation, reclassification of shares or capital reorganization of the corporate stockholder, or pursuant to a sale of all or substantially all of the stock or assets of a corporate stockholder.
(6)
A corporate stockholder’s transfer of any or all of its shares of common stock to any or all of its stockholders.
(7)
A transfer by a stockholder which is a limited or general partnership to any or all of its partners.
In any such case, the transferee, assignee, or other recipient shall receive and hold such stock subject to the provisions of this section, and there shall be no further transfer of such stock except in accord with this section.
(f)
The provisions of this section may be waived with respect to any transfer either by the Corporation, upon duly authorized action of its Board of Directors, or by the stockholders, upon the express written consent of the owners of a majority of the voting power of the Corporation (excluding the votes represented by those shares to be sold by the selling stockholder). This section may be amended or repealed either by a duly authorized action of the Board of Directors or by the stockholders, upon the express written consent of the owners of a majority of the voting power of the Corporation.
(g)
Any sale or transfer, or purported sale or transfer, of securities of the Corporation by stockholders shall be null and void unless the terms, conditions, and provisions of this bylaw are strictly observed and followed.
(h)
The foregoing right of first refusal shall terminate upon the date securities of the Corporation are first offered to the public pursuant to a registration statement filed with, and declared effective by, the Securities and Exchange Commission under the Securities Act of 1933, as amended.
(i)
The certificates representing shares of common stock of the Corporation shall bear on their face the following legend so long as the foregoing right of first refusal remains in effect:
“THE SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO A RIGHT OF FIRST REFUSAL OPTION, AS PROVIDED IN THE BYLAWS OF THE CORPORATION.”
(j)
Whenever the Corporation shall have the right to purchase common stock under this right of first refusal, the Corporation may designate and assign to one or more employees, officers, directors or stockholders of the Corporation or other persons or organizations, to exercise all or a part of the Corporation’s right of first refusal.”
IN WITNESS WHEREOF, the undersigned has executed this Certificate of Amendment of the Bylaws as of the date first written above.
|
|
/s/
Anie K. Roche
|
Anie K. Roche
|
Secretary
|
CERTIFICATE OF AMENDMENT OF
THE BYLAWS
OF
TIGERCAT PHARMA, INC.
The undersigned, Anie K Roche, hereby certifies that:
1.
She is the duly elected and acting Secretary of Tigercat Pharma Inc., a Delaware corporation (the “Corporation”).
2.
Effective July 31, the Bylaws of the Corporation are amended as follows:
(a)
In each instance in the Bylaws of the Corporation where the term “Stockholders Agreement” occurs, such term is hereby replaced with the term “Amended and Restated Voting Agreement.”
IN WITNESS WHEREOF, the undersigned has executed this Certificate of Amendment of the Bylaws as of the date first written above.
|
|
/s/
Anie K. Roche
|
Anie K. Roche
|
Secretary
|
AMENDED AND RESTATED BYLAWS OF
MENLO THERAPEUTICS INC.
(a Delaware corporation)
TABLE OF CONTENTS
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ARTICLE I - CORPORATE OFFICES
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1.1
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REGISTERED OFFICE
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1.2
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OTHER OFFICES
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ARTICLE II - MEETINGS OF STOCKHOLDERS
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2.1
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PLACE OF MEETINGS
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2.2
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ANNUAL MEETING
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2.3
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SPECIAL MEETING
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2.4
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ADVANCE NOTICE PROCEDURES FOR BUSINESS BROUGHT BEFORE A MEETING
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2.5
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ADVANCE NOTICE PROCEDURES FOR NOMINATIONS OF DIRECTORS
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2.6
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NOTICE OF STOCKHOLDERS’ MEETINGS
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2.7
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MANNER OF GIVING NOTICE; AFFIDAVIT OF NOTICE
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2.8
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QUORUM
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2.9
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ADJOURNED MEETING; NOTICE
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2.10
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CONDUCT OF BUSINESS
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2.11
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VOTING
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2.12
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NO STOCKHOLDER ACTION BY WRITTEN CONSENT WITHOUT A MEETING
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2.13
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RECORD DATE FOR STOCKHOLDER NOTICE; VOTING; GIVING CONSENTS
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2.14
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PROXIES
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2.15
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LIST OF STOCKHOLDERS ENTITLED TO VOTE
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2.16
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INSPECTORS OF ELECTION
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ARTICLE III - DIRECTORS
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3.1
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POWERS
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3.2
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NUMBER OF DIRECTORS
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3.3
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ELECTION, QUALIFICATION AND TERM OF OFFICE OF DIRECTORS
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3.4
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RESIGNATION AND VACANCIES
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3.5
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PLACE OF MEETINGS; MEETINGS BY TELEPHONE
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3.6
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REGULAR MEETINGS
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3.7
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SPECIAL MEETINGS; NOTICE
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3.8
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QUORUM
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3.9
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BOARD ACTION BY WRITTEN CONSENT WITHOUT A MEETING
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3.10
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FEES AND COMPENSATION OF DIRECTORS
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3.11
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REMOVAL OF DIRECTORS
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ARTICLE IV - COMMITTEES
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4.1
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COMMITTEES OF DIRECTORS
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4.2
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COMMITTEE MINUTES
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4.3
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MEETINGS AND ACTION OF COMMITTEES
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ARTICLE V - OFFICERS
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5.1
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OFFICERS
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5.2
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APPOINTMENT OF OFFICERS
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5.3
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SUBORDINATE OFFICERS
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5.4
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REMOVAL AND RESIGNATION OF OFFICERS
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5.5
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VACANCIES IN OFFICES
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5.6
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REPRESENTATION OF SHARES OF OTHER CORPORATIONS
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5.7
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AUTHORITY AND DUTIES OF OFFICERS
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ARTICLE VI - RECORDS AND REPORTS
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6.1
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MAINTENANCE AND INSPECTION OF RECORDS
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6.2
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INSPECTION BY DIRECTORS
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ARTICLE VII - GENERAL MATTERS
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7.1
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EXECUTION OF CORPORATE CONTRACTS AND INSTRUMENTS
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7.2
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STOCK CERTIFICATES; PARTLY PAID SHARES
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7.3
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SPECIAL DESIGNATION ON CERTIFICATES
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7.4
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LOST CERTIFICATES
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7.5
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CONSTRUCTION; DEFINITIONS
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7.6
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DIVIDENDS
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7.7
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FISCAL YEAR
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7.8
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SEAL
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7.9
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TRANSFER OF STOCK
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7.10
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STOCK TRANSFER AGREEMENTS
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7.11
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REGISTERED STOCKHOLDERS
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7.12
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WAIVER OF NOTICE
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ARTICLE VIII - NOTICE BY ELECTRONIC TRANSMISSION
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8.1
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NOTICE BY ELECTRONIC TRANSMISSION
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8.2
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DEFINITION OF ELECTRONIC TRANSMISSION
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ARTICLE IX - INDEMNIFICATION
|
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9.1
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INDEMNIFICATION OF DIRECTORS AND OFFICERS
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9.2
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INDEMNIFICATION OF OTHERS
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9.3
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PREPAYMENT OF EXPENSES
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9.4
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DETERMINATION; CLAIM
|
9.5
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NON-EXCLUSIVITY OF RIGHTS
|
9.6
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INSURANCE
|
9.7
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OTHER INDEMNIFICATION
|
9.8
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CONTINUATION OF INDEMNIFICATION
|
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ARTICLE X - AMENDMENTS
|
AMENDED AND RESTATED
BYLAWS OF
MENLO THERAPEUTICS INC.
ARTICLE I - CORPORATE OFFICES
1.1 REGISTERED OFFICE.
The registered office of Menlo Therapeutics Inc. (the “
Corporation
”) shall be fixed in the Corporation’s certificate of incorporation, as the same may be amended from time to time (the “
Certificate of Incorporation
”).
1.2 OTHER OFFICES.
The Corporation’s board of directors (the “
Board
”) may at any time establish other offices at any place or places where the Corporation is qualified to do business.
ARTICLE II - MEETINGS OF STOCKHOLDERS
2.1 PLACE OF MEETINGS.
Meetings of stockholders shall be held at any place, within or outside the State of Delaware, designated by the Board. The Board may, in its sole discretion, determine that a meeting of stockholders shall not be held at any place, but may instead be held solely by means of remote communication as authorized by Section 211(a)(2) of the General Corporation Law of the State of Delaware (the “
DGCL
”). In the absence of any such designation or determination, stockholders’ meetings shall be held at the Corporation’s principal executive office.
2.2 ANNUAL MEETING.
The Board shall designate the date and time of the annual meeting. At the annual meeting, directors shall be elected and other proper business properly brought before the meeting in accordance with Section 2.4 may be transacted.
2.3 SPECIAL MEETING.
Except as otherwise provided by the Certificate of Incorporation, a special meeting of the stockholders may be called at any time by the Board, chief executive officer or president (in the absence of a chief executive officer), but such special meetings may not be called by the stockholders or any other person or persons.
No business may be transacted at such special meeting other than the business specified in the notice to stockholders. Nothing contained in this paragraph of this Section 2.3 shall be construed as limiting, fixing, or affecting the time when a meeting of stockholders called by action of the Board may be held.
2.4 ADVANCE NOTICE PROCEDURES FOR BUSINESS BROUGHT BEFORE A MEETING.
(i) At an annual meeting of the stockholders, only such business shall be conducted as shall have been properly brought before the meeting. To be properly brought before an annual meeting, business must be (a) specified in a notice of meeting given by or at the direction of the Board, (b) if not specified in a notice of meeting, otherwise brought before the meeting by or at the direction of the Board or the chairperson of the Board, or (c) otherwise properly brought before the meeting by a stockholder present in person who (A)(1) was a beneficial owner of shares of the Corporation both at the time of giving the notice provided for in this Section 2.4 and at the time of the meeting, (2) is entitled to vote at the meeting and (3) has complied with this Section 2.4 in all applicable respects, or (B) properly made such proposal in accordance with Rule 14a-8 under the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder (as so amended and inclusive of such rules and regulations, the “
Exchange Act
”). The foregoing clause (c) shall be the exclusive
means for a stockholder to propose business to be brought before an annual meeting of the stockholders. The only matters that may be brought before a special meeting are the matters specified in the notice of meeting given by or at the direction of the person calling the meeting pursuant to Section 2.3 of these bylaws, and stockholders shall not be permitted to propose business to be brought before a special meeting of the stockholders. For purposes of this Section 2.4, “present in person” shall mean that the stockholder proposing that the business be brought before the annual meeting of the Corporation, or, if the proposing stockholder is not an individual, a qualified representative of such proposing stockholder, appear at such annual meeting. A “qualified representative” of such proposing stockholder shall be, if such proposing stockholder is (x) a general or limited partnership, any general partner or person who functions as a general partner of the general or limited partnership or who controls the general or limited partnership, (y) a corporation or a limited liability company, any officer or person who functions as an officer of the corporation or limited liability company or any officer, director, general partner or person who functions as an officer, director or general partner of any entity ultimately in control of the corporation or limited liability company or (z) a trust, any trustee of such trust. Stockholders seeking to nominate persons for election to the Board must comply with Section 2.5 of these bylaws, and this Section 2.4 shall not be applicable to nominations except as expressly provided in Section 2.5 of these bylaws.
(ii) For business to be properly brought before an annual meeting by a stockholder, the stockholder must (a) provide Timely Notice (as defined below) thereof in writing and in proper form to the Secretary of the Corporation and (b) provide any updates or supplements to such notice at the times and in the forms required by this Section 2.4. To be timely, a stockholder’s notice must be delivered to, or mailed and received at, the principal executive offices of the Corporation not less than ninety (90) days nor more than one hundred twenty (120) days prior to the one-year anniversary of the preceding year’s annual meeting;
provided, however
, that if the date of the annual meeting is more than thirty (30) days before or more than sixty (60) days after such anniversary date, notice by the stockholder to be timely must be so delivered, or mailed and received, not later than the ninetieth (90
th
) day prior to such annual meeting or, if later, the tenth (10
th
) day following the day on which public disclosure of the date of such annual meeting was first made (such notice within such time periods, “
Timely Notice
”). In no event shall any adjournment or postponement of an annual meeting or the announcement thereof commence a new time period for the giving of Timely Notice as described above.
(iii) To be in proper form for purposes of this Section 2.4, a stockholder’s notice to the Secretary shall set forth:
(a) As to each Proposing Person (as defined below), (A) the name and address of such Proposing Person (including, if applicable, the name and address that appear on the Corporation’s books and records); and (B) the class or series and number of shares of the Corporation that are, directly or indirectly, owned of record or beneficially owned (within the meaning of Rule 13d-3 under the Exchange Act) by such Proposing Person, except that such Proposing Person shall in all events be deemed to beneficially own any shares of any class or series of the Corporation as to which such Proposing Person has a right to acquire beneficial ownership at any time in the future (the disclosures to be made pursuant to the foregoing clauses (A) and (B) are referred to as “
Stockholder Information
”);
(b) As to each Proposing Person, (A) the full notional amount of any securities that, directly or indirectly, underlie any “derivative security” (as such term is defined in Rule 16a-1(c) under the Exchange Act) that constitutes a “call equivalent position” (as such term is defined in Rule 16a-1(b) under the Exchange Act) (“
Synthetic Equity Position
”) and that is, directly or indirectly, held or maintained by such Proposing Person with respect to any shares of any class or series of shares of the Corporation;
provided
that, for the purposes of the definition of “Synthetic Equity Position,” the term “derivative security” shall also include any security or instrument that would not otherwise constitute a “derivative security” as a result of any feature that would make any conversion, exercise or similar right or privilege of such security or instrument becoming determinable only at some future date or upon the happening of a future occurrence, in which case the determination of the amount of securities into which such security or instrument would be convertible or exercisable shall be made assuming that such security or instrument is immediately convertible or exercisable at the time of such determination; and,
provided
,
further
, that any Proposing Person satisfying the requirements of Rule 13d-1(b)(1) under the Exchange Act (other than a Proposing Person that so satisfies Rule 13d-1(b)(1) under the Exchange Act solely by reason of Rule 13d-1(b)(1)(ii)(E)) shall not be deemed to hold or maintain the notional amount of any securities that underlie a Synthetic Equity Position held by such Proposing Person as a hedge with respect to a bona fide derivatives trade or position of such Proposing Person arising in the ordinary course of such Proposing Person’s business as a derivatives dealer, (B) any rights to dividends on the shares of any class or series of shares of the Corporation owned beneficially by such Proposing Person that are separated or separable from the underlying shares of the Corporation, (C)(x) if such Proposing Person is (i) a general or limited partnership, syndicate or other group, the identity of each general partner and each person who functions as a general partner of the general or limited partnership, each member of the syndicate or group and each person controlling the general partner or member, (ii) a corporation or a limited liability company, the identity of each officer and each person who functions as an
officer of the corporation or limited liability company, each person controlling the corporation or limited liability company and each officer, director, general partner and person who functions as an officer, director or general partner of any entity ultimately in control of the corporation or limited liability company or (iii) a trust, any trustee of such trust (each such person or persons set forth in the preceding clauses (i), (ii) and (iii), a “
Responsible Person
”), any fiduciary duties owed by such Responsible Person to the equity holders or other beneficiaries of such Proposing Person and any material interests or relationships of such Responsible Person that are not shared generally by other record or beneficial holders of the shares of any class or series of the Corporation and that reasonably could have influenced the decision of such Proposing Person to propose such business to be brought before the meeting, and (y) if such Proposing Person is a natural person, any material interests or relationships of such natural person that are not shared generally by other record or beneficial holders of the shares of any class or series of the Corporation and that reasonably could have influenced the decision of such Proposing Person to propose such business to be brought before the meeting, (D) any material shares or any Synthetic Equity Position in any principal competitor of the Corporation in any principal industry of the Corporation held by such Proposing Persons, (E) a summary of any material discussions regarding the business proposed to be brought before the meeting (x) between or among any of the Proposing Persons or (y) between or among any Proposing Person and any other record or beneficial holder of the shares of any class or series of the Corporation (including their names), (F) any material pending or threatened legal proceeding in which such Proposing Person is a party or material participant involving the Corporation or any of its officers or directors, or any affiliate of the Corporation, (G) any other material relationship between such Proposing Person, on the one hand, and the Corporation, any affiliate of the Corporation or any principal competitor of the Corporation, on the other hand, (H) any direct or indirect material interest in any material contract or agreement of such Proposing Person with the Corporation, any affiliate of the Corporation or any principal competitor of the Corporation (including, in any such case, any employment agreement, collective bargaining agreement or consulting agreement) and (I) any other information relating to such Proposing Person that would be required to be disclosed in a proxy statement or other filing required to be made in connection with solicitations of proxies or consents by such Proposing Person in support of the business proposed to be brought before the meeting pursuant to Section 14(a) of the Exchange Act (the disclosures to be made pursuant to the foregoing clauses (A) through (I) are referred to as “
Disclosable Interests
”);
provided
,
however
, that Disclosable Interests shall not include any such disclosures with respect to the ordinary course business activities of any broker, dealer, commercial bank, trust company or other nominee who is a Proposing Person solely as a result of being the stockholder directed to prepare and submit the notice required by these bylaws on behalf of a beneficial owner; and
(c) As to each item of business that the stockholder proposes to bring before the annual meeting, (A) a brief description of the business desired to be brought before the annual meeting, the reasons for conducting such business at the annual meeting and any material interest in such business of each Proposing Person, (B) the text of the proposal or business (including the text of any resolutions proposed for consideration and in the event that such business includes a proposal to amend the bylaws of the Corporation, the language of the proposed amendment), (C) a reasonably detailed description of all agreements, arrangements and understandings between or among any of the Proposing Persons or between or among any Proposing Person and any other person or entity (including their names) in connection with the proposal of such business by such stockholder and (D) any other information relating to such item of business that would be required to be disclosed in a proxy statement or other filing required to be made in connection with solicitations of proxies in support of the business proposed to be brought before the meeting pursuant to Section 14(a) of the Exchange Act;
provided
,
however
, that the disclosures required by this Section 2.4(iii) shall not include any disclosures with respect to any broker, dealer, commercial bank, trust company or other nominee who is a Proposing Person solely as a result of being the stockholder directed to prepare and submit the notice required by these bylaws on behalf of a beneficial owner.
(iv) For purposes of this Section 2.4, the term “
Proposing Person
”
shall mean (a) the stockholder providing the notice of business proposed to be brought before an annual meeting, (b) the beneficial owner or beneficial owners, if different, on whose behalf the notice of the business proposed to be brought before the annual meeting is made and (c) any participant (as defined in paragraphs (a)(ii)-(vi) of Instruction 3 to Item 4 of Schedule 14A) with such stockholder in such solicitation or associate (within the meaning of Rule 12b-2 under the Exchange Act for the purposes of these bylaws) of such stockholder or beneficial owner.
(v) A Proposing Person shall update and supplement its notice to the Corporation of its intent to propose business at an annual meeting, if necessary, so that the information provided or required to be provided in such notice pursuant to this Section 2.4 shall be true and correct as of the record date for notice of the meeting and as of the date that is ten (10) business days prior to the meeting or any adjournment or postponement thereof, and such update and supplement shall be delivered to, or mailed and received by, the Secretary at the principal executive offices of the Corporation not later than five (5) business days after the record date for notice of the meeting (in the case of the update and supplement required to be made as of such record date), and not later than eight (8) business days prior to the date for the meeting or, if practicable, any adjournment or
postponement thereof (and, if not practicable, on the first practicable date prior to the date to which the meeting has been adjourned or postponed) (in the case of the update and supplement required to be made as of ten (10) business days prior to the meeting or any adjournment or postponement thereof).
(vi) Notwithstanding anything in these bylaws to the contrary, no business shall be conducted at an annual meeting that is not properly brought before the meeting in accordance with this Section 2.4. The presiding officer of the meeting shall, if the facts warrant, determine that the business was not properly brought before the meeting in accordance with this Section 2.4, and if he or she should so determine, he or she shall so declare to the meeting and any such business not properly brought before the meeting shall not be transacted.
(vii) This Section 2.4 is expressly intended to apply to any business proposed to be brought before an annual meeting of stockholders, other than any proposal made in accordance with Rule 14a-8 under the Exchange Act and included in the Corporation’s proxy statement. In addition to the requirements of this Section 2.4 with respect to any business proposed to be brought before an annual meeting, each Proposing Person shall comply with all applicable requirements of the Exchange Act with respect to any such business. Nothing in this Section 2.4 shall be deemed to affect the rights of stockholders to request inclusion of proposals in the Corporation’s proxy statement pursuant to Rule 14a-8 under the Exchange Act.
(viii) For purposes of these bylaws, “
public disclosure
” shall mean disclosure in a press release reported by a national news service or in a document publicly filed by the Corporation with the Securities and Exchange Commission pursuant to Sections 13, 14 or 15(d) of the Exchange Act.
2.5 ADVANCE NOTICE PROCEDURES FOR NOMINATIONS OF DIRECTORS.
(i) Nominations of any person for election to the Board at an annual meeting or at a special meeting (but only if the election of directors is a matter specified in the notice of meeting given by or at the direction of the person calling such special meeting) may be made at such meeting only (a) by or at the direction of the Board, including by any committee or persons authorized to do so by the Board or these bylaws, or (b) by a stockholder present in person (A) who was a beneficial owner of shares of the Corporation both at the time of giving the notice provided for in this Section 2.5 and at the time of the meeting, (B) is entitled to vote at the meeting and (C) has complied with this Section 2.5 as to such notice and nomination. The foregoing clause (b) shall be the exclusive means for a stockholder to make any nomination of a person or persons for election to the Board at an annual meeting or special meeting. For purposes of this Section 2.5, “present in person” shall mean that the stockholder proposing that the business be brought before the meeting of the Corporation, or, if the proposing stockholder is not an individual, a qualified representative of such stockholder, appear at such meeting. A “qualified representative” of such proposing stockholder shall be, if such proposing stockholder is (x) a general or limited partnership, any general partner or person who functions as a general partner of the general or limited partnership or who controls the general or limited partnership, (y) a corporation or a limited liability company, any officer or person who functions as an officer of the corporation or limited liability company or any officer, director, general partner or person who functions as an officer, director or general partner of any entity ultimately in control of the corporation or limited liability company or (z) a trust, any trustee of such trust.
(ii) Without qualification, for a stockholder to make any nomination of a person or persons for election to the Board at an annual meeting, the stockholder must (a) provide Timely Notice (as defined in Section 2.4(ii) of these bylaws) thereof in writing and in proper form to the Secretary of the Corporation, (b) provide the information with respect to such stockholder and its proposed nominee as required by this Section 2.5, and (c) provide any updates or supplements to such notice at the times and in the forms required by this Section 2.5. Without qualification, if the election of directors is a matter specified in the notice of meeting given by or at the direction of the person calling such special meeting, then for a stockholder to make any nomination of a person or persons for election to the Board at a special meeting, the stockholder must (a) provide timely notice thereof in writing and in proper form to the Secretary of the Corporation at the principal executive offices of the Corporation, (b) provide the information with respect to such stockholder and its proposed nominee as required by this Section 2.5, and (c) provide any updates or supplements to such notice at the times and in the forms required by this Section 2.5. To be timely, a stockholder’s notice for nominations to be made at a special meeting must be delivered to, or mailed and received at, the principal executive offices of the Corporation not earlier than the one hundred twentieth (120
th
) day prior to such special meeting and not later than the ninetieth (90
th
) day prior to such special meeting or, if later, the tenth (10
th
) day following the day on which public disclosure (as defined in Section 2.4(ix) of these bylaws) of the date of such special meeting was first made. In no event shall any adjournment or postponement of an annual meeting or special meeting or the announcement thereof commence a new time period for the giving of a stockholder’s notice as described above.
(iii) To be in proper form for purposes of this Section 2.5, a stockholder’s notice to the Secretary shall set forth:
(a) As to each Nominating Person (as defined below), the Stockholder Information (as defined in Section 2.4(iii)(a) of these bylaws) except that for purposes of this Section 2.5, the term “Nominating Person” shall be substituted for the term “Proposing Person” in all places it appears in Section 2.4(iii)(a);
(b) As to each Nominating Person, any Disclosable Interests (as defined in Section 2.4(iii)(b), except that for purposes of this Section 2.5 the term “Nominating Person” shall be substituted for the term “Proposing Person” in all places it appears in Section 2.4(iii)(b) and the disclosure with respect to the business to be brought before the meeting in Section 2.4(iii)(b) shall be made with respect to the election of directors at the meeting);
(c) As to each person whom a Nominating Person proposes to nominate for election as a director, (A) all information with respect to such proposed nominee that would be required to be set forth in a stockholder’s notice pursuant to this Section 2.5 if such proposed nominee were a Nominating Person, (B) all information relating to such proposed nominee that is required to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for election of directors in a contested election pursuant to Section 14(a) under the Exchange Act (including such proposed nominee’s written consent to being named in the proxy statement as a nominee and to serving as a director if elected), (C) a description of any direct or indirect material interest in any material contract or agreement between or among any Nominating Person, on the one hand, and each proposed nominee or his or her respective associates or any other participants in such solicitation, on the other hand, including, without limitation, all information that would be required to be disclosed pursuant to Item 404 under Regulation S-K if such Nominating Person were the “registrant” for purposes of such rule and the proposed nominee were a director or executive officer of such registrant (the disclosures to be made pursuant to the foregoing clauses (A) through (C) are referred to as “
Nominee Information
”), and (D) a completed and signed questionnaire, representation and agreement as provided in Section 2.5(vi); and
(d) The Corporation may require any proposed nominee to furnish such other information (A) as may reasonably be required by the Corporation to determine the eligibility of such proposed nominee to serve as an independent director of the Corporation in accordance with the Corporation’s Corporate Governance Guidelines or (B) that could be material to a reasonable stockholder’s understanding of the independence or lack of independence of such proposed nominee.
(iv) For purposes of this Section 2.5, the term “
Nominating Person
”
shall mean (a) the stockholder providing the notice of the nomination proposed to be made at the meeting, (b) the beneficial owner or beneficial owners, if different, on whose behalf the notice of the nomination proposed to be made at the meeting is made and (c) any associate of such stockholder or beneficial owner or any other participant in such solicitation.
(v) A stockholder providing notice of any nomination proposed to be made at a meeting shall further update and supplement such notice, if necessary, so that the information provided or required to be provided in such notice pursuant to this Section 2.5 shall be true and correct as of the record date for notice of the meeting and as of the date that is ten (10) business days prior to the meeting or any adjournment or postponement thereof, and such update and supplement shall be delivered to, or mailed and received by, the Secretary at the principal executive offices of the Corporation not later than five (5) business days after the record date for notice of the meeting (in the case of the update and supplement required to be made as of such record date), and not later than eight (8) business days prior to the date for the meeting or, if practicable, any adjournment or postponement thereof (and, if not practicable, on the first practicable date prior to the date to which the meeting has been adjourned or postponed) (in the case of the update and supplement required to be made as of ten (10) business days prior to the meeting or any adjournment or postponement thereof).
(vi) To be eligible to be a nominee for election as a director of the Corporation at an annual or special meeting, the proposed nominee must be nominated in the manner prescribed in Section 2.5 and must deliver (in accordance with the time period prescribed for delivery in a notice to such proposed nominee given by or on behalf of the Board), to the Secretary at the principal executive offices of the Corporation, (a) a completed written questionnaire (in a form provided by the Corporation) with respect to the background, qualifications, stock ownership and independence of such proposed nominee and (b) a written representation and agreement (in form provided by the Corporation) that such proposed nominee (A) is not and, if elected as a director during his or her term of office, will not become a party to (1) any agreement, arrangement or understanding with, and has not given and will not give any commitment or assurance to, any person or entity as to how such proposed nominee, if elected as a director of the Corporation, will act or vote on any issue or question (a “
Voting Commitment
”) or (2) any Voting Commitment that could limit or interfere with such proposed nominee’s ability to comply, if elected as a director of the Corporation, with such proposed nominee’s fiduciary duties under applicable law, (B) is not, and
will not become a party to, any agreement, arrangement or understanding with any person or entity other than the Corporation with respect to any direct or indirect compensation or reimbursement for service as a director and (C) if elected as a director of the Corporation, will comply with all applicable corporate governance, conflict of interest, confidentiality, stock ownership and trading and other policies and guidelines of the Corporation applicable to directors and in effect during such person’s term in office as a director (and, if requested by any proposed nominee, the Secretary of the Corporation shall provide to such proposed nominee all such policies and guidelines then in effect).
(vii) In addition to the requirements of this Section 2.5 with respect to any nomination proposed to be made at a meeting, each Proposing Person shall comply with all applicable requirements of the Exchange Act with respect to any such nominations.
(viii) No proposed nominee shall be eligible for nomination as a director of the Corporation unless such proposed nominee and the Nominating Person seeking to place such proposed nominee’s name in nomination have complied with this Section 2.5, as applicable. The presiding officer at the meeting shall, if the facts warrant, determine that a nomination was not properly made in accordance with this Section 2.5, and if he or she should so determine, he or she shall so declare such determination to the meeting, the defective nomination shall be disregarded and any ballots cast for the proposed nominee in question (but in the case of any form of ballot listing other qualified nominees, only the ballots case for the nominee in question) shall be void and of no force or effect.
2.6 NOTICE OF STOCKHOLDERS’ MEETINGS.
Unless otherwise provided by law, the Certificate of Incorporation or these bylaws, the notice of any meeting of stockholders shall be sent or otherwise given in accordance with either Section 2.7 or Section 8.1 of these bylaws not less than ten (10) nor more than sixty (60) days before the date of the meeting to each stockholder entitled to vote at such meeting. The notice shall specify the place, if any, date and hour of the meeting, the means of remote communication, if any, by which stockholders and proxy holders may be deemed to be present in person and vote at such meeting, and, in the case of a special meeting, the purpose or purposes for which the meeting is called.
2.7 MANNER OF GIVING NOTICE; AFFIDAVIT OF NOTICE.
Notice of any meeting of stockholders shall be deemed given:
(i) if mailed, when deposited in the U.S. mail, postage prepaid, directed to the stockholder at his or her address as it appears on the Corporation’s records; or
(ii) if electronically transmitted as provided in Section 8.1 of these bylaws.
An affidavit of the secretary or an assistant secretary of the Corporation or of the transfer agent or any other agent of the Corporation that the notice has been given by mail or by a form of electronic transmission, as applicable, shall, in the absence of fraud, be prima facie evidence of the facts stated therein.
2.8 QUORUM.
Unless otherwise provided by law, the Certificate of Incorporation or these bylaws, the holders of a majority in voting power of the stock issued and outstanding and entitled to vote, present in person, or by remote communication, if applicable, or represented by proxy, shall constitute a quorum for the transaction of business at all meetings of the stockholders. If, however, a quorum is not present or represented at any meeting of the stockholders, then either (i) the chairperson of the meeting or (ii) a majority in voting power of the stockholders entitled to vote at the meeting, present in person, or by remote communication, if applicable, or represented by proxy, shall have power to adjourn the meeting from time to time in the manner provided in Section 2.9 of these bylaws until a quorum is present or represented. At such adjourned meeting at which a quorum is present or represented, any business may be transacted that might have been transacted at the meeting as originally noticed.
2.9 ADJOURNED MEETING; NOTICE.
When a meeting is adjourned to another time or place, unless these bylaws otherwise require, notice need not be given of the adjourned meeting if the time, place, if any, thereof, and the means of remote communications, if any, by which stockholders
and proxy holders may be deemed to be present in person and vote at such adjourned meeting are announced at the meeting at which the adjournment is taken. At the adjourned meeting, the Corporation may transact any business which might have been transacted at the original meeting. If the adjournment is for more than thirty (30) days, or if after the adjournment a new record date is fixed for the adjourned meeting, a notice of the adjourned meeting shall be given to each stockholder of record entitled to vote at the meeting.
2.10 CONDUCT OF BUSINESS.
The chairperson of any meeting of stockholders shall determine the order of business and the procedure at the meeting, including such regulation of the manner of voting and the conduct of business.
2.11 VOTING.
The stockholders entitled to vote at any meeting of stockholders shall be determined in accordance with the provisions of Section 2.13 of these bylaws, subject to Section 217 (relating to voting rights of fiduciaries, pledgors and joint owners of stock) and Section 218 (relating to voting trusts and other voting agreements) of the DGCL.
Except as may be otherwise provided in the Certificate of Incorporation or these bylaws, each stockholder shall be entitled to one (1) vote for each share of capital stock held by such stockholder.
At all duly called or convened meetings of stockholders, at which a quorum is present, for the election of directors, a plurality of the votes cast shall be sufficient to elect a director. Except as otherwise provided by the Certificate of Incorporation, these bylaws, the rules or regulations of any stock exchange applicable to the Corporation, or applicable law or pursuant to any regulation applicable to the Corporation or its securities, all other elections and questions presented to the stockholders at a duly called or convened meeting, at which a quorum is present, shall be decided by the majority of the votes cast affirmatively or negatively (excluding abstentions and broker non-votes) and shall be valid and binding upon the Corporation.
2.12 NO STOCKHOLDER ACTION BY WRITTEN CONSENT WITHOUT A MEETING.
Subject to the rights of the holders of the shares of any series of Preferred Stock or any other class of stock or series thereof having a preference over the Common Stock as to dividends or upon liquidation, and except as otherwise provided in the Certificate of Incorporation, any action required or permitted to be taken by the stockholders of the Corporation must be effected at a duly called annual or special meeting of stockholders of the Corporation and may not be effected by any consent in writing by such stockholders.
2.13 RECORD DATE FOR STOCKHOLDER NOTICE; VOTING; GIVING CONSENTS.
In order that the Corporation may determine the stockholders entitled to notice of or to vote at any meeting of stockholders or any adjournment thereof, or entitled to receive payment of any dividend or other distribution or allotment of any rights, or 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, in advance, a record date, which record date shall not precede the date on which the resolution fixing the record date is adopted and which shall not be more than sixty (60) nor less than ten (10) days before the date of such meeting, nor more than sixty (60) days prior to any other such action.
If the Board does not so fix a record date:
(i) The record date for determining stockholders entitled to notice of or to vote at a meeting of stockholders shall be at the close of business on the day next preceding the day on which notice is given, or, if notice is waived, at the close of business on the day next preceding the day on which the meeting is held.
(ii) The record date for determining stockholders for any other purpose shall be at the close of business on the day on which the Board adopts the resolution relating thereto.
A determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders shall apply to any adjournment of the meeting;
provided, however
, that the Board may fix a new record date for the adjourned meeting.
2.14 PROXIES.
Each stockholder entitled to vote at a meeting of stockholders may authorize another person or persons to act for such stockholder by proxy authorized by an instrument in writing or by a transmission permitted by law filed in accordance with the procedure established for the meeting, but no such proxy shall be voted or acted upon after three (3) years from its date, unless the proxy provides for a longer period. The revocability of a proxy that states on its face that it is irrevocable shall be governed by the provisions of Section 212 of the DGCL. A proxy may be in the form of a telegram, cablegram or other means of electronic transmission which sets forth or is submitted with information from which it can be determined that the telegram, cablegram or other means of electronic transmission was authorized by the stockholder.
2.15 LIST OF STOCKHOLDERS ENTITLED TO VOTE.
The officer who has charge of the stock ledger of the Corporation shall prepare and make, at least ten (10) days before every meeting of stockholders, a complete list of the stockholders entitled to vote at the meeting, arranged in alphabetical order, and showing the address of each stockholder and the number of shares registered in the name of each stockholder. The Corporation shall not be required to include electronic mail addresses or other electronic contact information on such list. Such list shall be open to the examination of any stockholder, for any purpose germane to the meeting for a period of at least ten (10) days prior to the meeting: (i) on a reasonably accessible electronic network, provided that the information required to gain access to such list is provided with the notice of the meeting, or (ii) during ordinary business hours, at the Corporation’s principal executive office. In the event that the Corporation determines to make the list available on an electronic network, the Corporation may take reasonable steps to ensure that such information is available only to stockholders of the Corporation. If the meeting is to be held at a place, then the list shall be produced and kept at the time and place of the meeting during the whole time thereof, and may be inspected by any stockholder who is present. If the meeting is to be held solely by means of remote communication, then the list shall also be open to the examination of any stockholder during the whole time of the meeting on a reasonably accessible electronic network, and the information required to access such list shall be provided with the notice of the meeting. Such list shall presumptively determine the identity of the stockholders entitled to vote at the meeting and the number of shares held by each of them.
2.16 INSPECTORS OF ELECTION.
Before any meeting of stockholders, the Board shall appoint an inspector or inspectors of election to act at the meeting or its adjournment and make a written report thereof. The number of inspectors shall be either one (1) or three (3). If any person appointed as inspector fails to appear or fails or refuses to act, then the chairperson of the meeting may, and upon the request of any stockholder or a stockholder’s proxy shall, appoint a person to fill that vacancy.
Such inspectors shall:
(i) determine the number of shares outstanding and the voting power of each, the number of shares represented at the meeting, the existence of a quorum, and the authenticity, validity, and effect of proxies;
(ii) receive votes or ballots;
(iii) hear and determine all challenges and questions in any way arising in connection with the right to vote;
(iv) count and tabulate all votes;
(v) determine when the polls shall close;
(vi) determine the result; and
(vii) do any other acts that may be proper to conduct the election or vote with fairness to all stockholders.
The inspectors of election shall perform their duties impartially, in good faith, to the best of their ability and as expeditiously as is practical. If there are three (3) inspectors of election, the decision, act or certificate of a majority is effective in all respects as the decision, act or certificate of all. Any report or certificate made by the inspectors of election is prima facie evidence of the facts stated therein. The inspectors of election may appoint such persons to assist them in performing their duties as they determine.
ARTICLE III - DIRECTORS
3.1 POWERS.
Subject to the provisions of the DGCL and any limitations in the Certificate of Incorporation or these bylaws relating to action required to be approved by the stockholders or by the outstanding shares, the business and affairs of the Corporation shall be managed and all corporate powers shall be exercised by or under the direction of the Board.
3.2 NUMBER OF DIRECTORS.
The authorized number of directors shall be determined from time to time by resolution of the Board, provided the Board shall consist of at least one member. No reduction of the authorized number of directors shall have the effect of removing any director before that director’s term of office expires.
3.3 ELECTION, QUALIFICATION AND TERM OF OFFICE OF DIRECTORS.
Except as provided in Section 3.4 of these bylaws, each director, including a director elected to fill a vacancy, shall hold office until the expiration of the term for which elected and until such director’s successor is elected and qualified or until such director’s earlier death, resignation or removal. Directors need not be stockholders unless so required by the Certificate of Incorporation or these bylaws. The Certificate of Incorporation or these bylaws may prescribe other qualifications for directors.
As provided in the Certificate of Incorporation, the directors of the Corporation shall be divided into three (3) classes.
3.4 RESIGNATION AND VACANCIES.
Any director may resign at any time upon notice given in writing or by electronic transmission to the Corporation. When one or more directors so resigns and the resignation is effective at a future date, a majority of the directors then in office, including those who have so resigned, shall have power to fill such vacancy or vacancies, the vote thereon to take effect when such resignation or resignations shall become effective, and each director so chosen shall hold office as provided in this section in the filling of other vacancies.
Unless otherwise provided in the Certificate of Incorporation or these bylaws, vacancies and newly created directorships resulting from any increase in the authorized number of directors shall, unless the Board determines by resolution that any such vacancies or newly created directorships shall be filled by stockholders, be filled only by a majority of the directors then in office, although less than a quorum, or by a sole remaining director. Any director elected in accordance with the preceding sentence shall hold office for the remainder of the full term of the director for which the vacancy was created or occurred and until such director’s successor shall have been elected and qualified. A vacancy in the Board of Directors shall be deemed to exist under these bylaws in the case of the death, removal or resignation of any director.
3.5 PLACE OF MEETINGS; MEETINGS BY TELEPHONE.
The Board may hold meetings, both regular and special, either within or outside the State of Delaware.
Unless otherwise restricted by the Certificate of Incorporation or these bylaws, members of the Board, or any committee designated by the Board, may participate in a meeting of the Board, or any committee, by means of conference telephone or other communications equipment by means of which all persons participating in the meeting can hear each other, and such participation in a meeting pursuant to this bylaw shall constitute presence in person at the meeting.
3.6 REGULAR MEETINGS.
Regular meetings of the Board may be held without notice at such time and at such place as shall from time to time be determined by the Board.
3.7 SPECIAL MEETINGS; NOTICE.
Special meetings of the Board for any purpose or purposes may be called at any time by the chairperson of the Board, the chief executive officer, the president, the secretary or a majority of the authorized number of directors.
Notice of the time and place of special meetings shall be:
(i) delivered personally by hand, by courier or by telephone;
(ii) sent by United States first-class mail, postage prepaid;
(iii) sent by facsimile; or
(iv) sent by electronic mail,
directed to each director at that director’s address, telephone number, facsimile number or electronic mail address, as the case may be, as shown on the Corporation’s records.
If the notice is (i) delivered personally by hand, by courier or by telephone, (ii) sent by facsimile or (iii) sent by electronic mail, it shall be delivered or sent at least twenty-four (24) hours before the time of the holding of the meeting. If the notice is sent by U.S. mail, it shall be deposited in the U.S. mail at least four (4) days before the time of the holding of the meeting. Any oral notice may be communicated to the director. The notice need not specify the place of the meeting (if the meeting is to be held at the Corporation’s principal executive office) nor the purpose of the meeting.
3.8 QUORUM.
At all meetings of the Board, a majority of the authorized number of directors shall constitute a quorum for the transaction of business. The vote of a majority of the directors present at any meeting at which a quorum is present shall be the act of the Board, except as may be otherwise specifically provided by statute, the Certificate of Incorporation or these bylaws. If a quorum is not present at any meeting of the Board, then the directors present thereat may adjourn the meeting from time to time, without notice other than announcement at the meeting, until a quorum is present.
A meeting at which a quorum is initially present may continue to transact business notwithstanding the withdrawal of directors, if any action taken is approved by at least a majority of the required quorum for that meeting.
3.9 BOARD ACTION BY WRITTEN CONSENT WITHOUT A MEETING.
Unless otherwise restricted by the Certificate of Incorporation or these bylaws, any action required or permitted to be taken at any meeting of the Board, or of any committee thereof, may be taken without a meeting if all members of the Board or committee, as the case may be, consent thereto in writing or by electronic transmission and the writing or writings or electronic transmission or transmissions are filed with the minutes of proceedings of the Board or committee. Such filing shall be in paper form if the minutes are maintained in paper form and shall be in electronic form if the minutes are maintained in electronic form.
3.10 FEES AND COMPENSATION OF DIRECTORS.
Unless otherwise restricted by the Certificate of Incorporation or these bylaws, the Board shall have the authority to fix the compensation of directors.
3.11 REMOVAL OF DIRECTORS.
Except as otherwise provided by the DGCL or the Certificate of Incorporation, the Board of Directors or any individual director may be removed from office at any time, but only with cause by the affirmative vote of the holders of at least sixty six and two thirds percent (66-2/3%) of the voting power of all the then outstanding shares of voting stock of the Corporation with the power to vote at an election of directors (the “
Voting Stock
”).
No reduction of the authorized number of directors shall have the effect of removing any director prior to the expiration of such director’s term of office.
ARTICLE IV - COMMITTEES
4.1 COMMITTEES OF DIRECTORS.
The Board may designate one (1) or more committees, each committee to consist of one (1) or more of the directors of the Corporation. The Board may designate one (1) or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of the committee. In the absence or disqualification of a member of a committee, the member or members thereof present at any meeting and not disqualified from voting, whether or not such member or members 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 provided in the resolution of the Board or in these bylaws, shall have and may exercise all the powers and authority of the Board in the management of the business and affairs of the Corporation, and may authorize the seal of the Corporation to be affixed to all papers that may require it; but no such committee shall have the power or authority to (i) approve or adopt, or recommend to the stockholders, any action or matter expressly required by the DGCL to be submitted to stockholders for approval, or (ii) adopt, amend or repeal any bylaw of the Corporation.
4.2 COMMITTEE MINUTES.
Each committee shall keep regular minutes of its meetings and report the same to the Board when required.
4.3 MEETINGS AND ACTION OF COMMITTEES.
Meetings and actions of committees shall be governed by, and held and taken in accordance with, the provisions of:
(i) Section 3.5 (place of meetings and meetings by telephone);
(ii) Section 3.6 (regular meetings);
(iii) Section 3.7 (special meetings and notice);
(iv) Section 3.8 (quorum);
(v) Section 7.12 (waiver of notice); and
(vi) Section 3.9 (action without a meeting),
with such changes in the context of those bylaws as are necessary to substitute the committee and its members for the Board and its members.
However
:
(i) the time of regular meetings of committees may be determined either by resolution of the Board or by resolution of the committee;
(ii) special meetings of committees may also be called by resolution of the Board or the chairperson of the applicable committee;
(iii) notice of special meetings of committees shall also be given to all alternate members, who shall have the right to attend all meetings of the committee; and
(iv) the Board may adopt rules for the governance of any committee to override the provisions that would otherwise apply to the committee pursuant to this Section 4.3, provided that such rules do not violate the provisions of the Certificate of Incorporation or applicable law.
ARTICLE V - OFFICERS
5.1 OFFICERS.
The officers of the Corporation shall be a president and a secretary. The Corporation may also have, at the discretion of the Board, a chairperson of the Board, a vice chairperson of the Board, a chief executive officer, a chief financial officer or treasurer, one (1) or more vice presidents, one (1) or more assistant vice presidents, one (1) or more assistant treasurers, one (1) or more assistant secretaries, and any such other officers as may be appointed in accordance with the provisions of these bylaws. Any number of offices may be held by the same person.
5.2 APPOINTMENT OF OFFICERS.
The Board shall appoint the officers of the Corporation, except such officers as may be appointed in accordance with the provisions of Section 5.3 of these bylaws, subject to the rights, if any, of an officer under any contract of employment.
5.3 SUBORDINATE OFFICERS.
The Board may appoint, or empower the chief executive officer or, in the absence of a chief executive officer, the president, to appoint, such other officers and agents as the business of the Corporation may require. Each of such officers and agents shall hold office for such period, have such authority, and perform such duties as are provided in these bylaws or as the Board may from time to time determine.
5.4 REMOVAL AND RESIGNATION OF OFFICERS.
Subject to the rights, if any, of an officer under any contract of employment, any officer may be removed, either with or without cause, by an affirmative vote of the majority of the Board at any regular or special meeting of the Board or, except in the case of an officer chosen by the Board, by any officer upon whom such power of removal may be conferred by the Board.
Any officer may resign at any time by giving written notice to the Corporation. Any resignation shall take effect at the date of the receipt of that notice or at any later time specified in that notice. Unless otherwise specified in the notice of resignation, the acceptance of the resignation shall not be necessary to make it effective. Any resignation is without prejudice to the rights, if any, of the Corporation under any contract to which the officer is a party.
5.5 VACANCIES IN OFFICES.
Any vacancy occurring in any office of the Corporation shall be filled by the Board or as provided in Section 5.2.
5.6 REPRESENTATION OF SHARES OF OTHER CORPORATIONS.
The chairperson of the Board, the chief executive officer, the president, any vice president, the treasurer, the secretary or assistant secretary of this Corporation, or any other person authorized by the Board , the chief executive officer, the president or a vice president, is authorized to vote, represent and exercise on behalf of this Corporation all rights incident to any and all shares of any other corporation or corporations standing in the name of this Corporation. The authority granted herein may be exercised either by such person directly or by any other person authorized to do so by proxy or power of attorney duly executed by such person having the authority.
5.7 AUTHORITY AND DUTIES OF OFFICERS.
All officers of the Corporation shall respectively have such authority and perform such duties in the management of the business of the Corporation as may be designated from time to time by the Board or the stockholders and, to the extent not so provided, as generally pertain to their respective offices, subject to the control of the Board.
ARTICLE VI - RECORDS AND REPORTS
6.1 MAINTENANCE AND INSPECTION OF RECORDS.
The Corporation shall, either at its principal executive office or at such place or places as designated by the Board, keep a record of its stockholders listing their names and addresses and the number and class of shares held by each stockholder, a copy of these bylaws as amended to date, accounting books and other records.
Any stockholder of record, in person or by attorney or other agent, shall, upon written demand under oath stating the purpose thereof, have the right during the usual hours for business to inspect for any proper purpose the Corporation’s stock ledger, a list of its stockholders, and its other books and records and to make copies or extracts therefrom. A proper purpose shall mean a purpose reasonably related to such person’s interest as a stockholder. In every instance where an attorney or other agent is the person who seeks the right to inspection, the demand under oath shall be accompanied by a power of attorney or such other writing that authorizes the attorney or other agent so to act on behalf of the stockholder. The demand under oath shall be directed to the Corporation at its registered office in Delaware or at its principal executive office.
6.2 INSPECTION BY DIRECTORS.
Any director shall have the right to examine the Corporation’s stock ledger, a list of its stockholders, and its other books and records for a purpose reasonably related to his or her position as a director. The Court of Chancery is hereby vested with the exclusive jurisdiction to determine whether a director is entitled to the inspection sought. The Court may summarily order the Corporation to permit the director to inspect any and all books and records, the stock ledger, and the stock list and to make copies or extracts therefrom. The Court may, in its discretion, prescribe any limitations or conditions with reference to the inspection, or award such other and further relief as the Court may deem just and proper.
ARTICLE VII - GENERAL MATTERS
7.1 EXECUTION OF CORPORATE CONTRACTS AND INSTRUMENTS.
The Board, except as otherwise provided in these bylaws, may authorize any officer or officers, or agent or agents, to enter into any contract or execute any instrument in the name of and on behalf of the Corporation; such authority may be general or confined to specific instances. Unless so authorized or ratified by the Board or within the agency power of an officer, no officer, agent or employee shall have any power or authority to bind the Corporation by any contract or engagement or to pledge its credit or to render it liable for any purpose or for any amount.
7.2 STOCK CERTIFICATES; PARTLY PAID SHARES.
The shares of the Corporation shall be represented by certificates or shall be uncertificated. Certificates for the shares of stock, if any, shall be in such form as is consistent with the Certificate of Incorporation and applicable law. Every holder of stock represented by a certificate shall be entitled to have a certificate signed by, or in the name of the Corporation by the chairperson or vice-chairperson of the Board, or the president or vice-president, and by the treasurer
or an assistant treasurer, or the secretary or an assistant secretary of the Corporation representing the number of shares registered in certificate form. Any or all of the signatures on the certificate may be a facsimile. In case any officer, transfer agent or registrar who has signed or whose facsimile signature has been placed upon a certificate has ceased to be such officer, transfer agent or registrar before such certificate is issued, it may be issued by the Corporation with the same effect as if he or she were such officer, transfer agent or registrar at the date of issue.
The Corporation may issue the whole or any part of its shares as partly paid and subject to call for the remainder of the consideration to be paid therefor. Upon the face or back of each stock certificate issued to represent any such partly paid shares, upon the books and records of the Corporation in the case of uncertificated partly paid shares, the total amount of the consideration to be paid therefor and the amount paid thereon shall be stated. Upon the declaration of any dividend on fully paid shares, the Corporation shall declare a dividend upon partly paid shares of the same class, but only upon the basis of the percentage of the consideration actually paid thereon.
7.3 SPECIAL DESIGNATION ON CERTIFICATES.
If the Corporation is authorized to issue more than one class of stock or more than one series of any class, then the powers, the designations, the preferences and the relative, participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights shall be set forth in full or summarized on the face or back of the certificate that the Corporation shall issue to represent such class or series of stock;
provided, however
, that, except as otherwise provided in Section 202 of the DGCL, in lieu of the foregoing requirements, there may be set forth on the face or back of the certificate that the Corporation shall issue to represent such class or series of stock a statement that the Corporation will furnish without charge to each stockholder who so requests the powers, the designations, the preferences and the relative, participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights.
7.4 LOST CERTIFICATES.
Except as provided in this Section 7.4, no new certificates for shares shall be issued to replace a previously issued certificate unless the latter is surrendered to the Corporation and cancelled at the same time. The Corporation may issue a new certificate of stock or uncertificated shares in the place of any certificate theretofore issued by it, alleged to have been lost, stolen or destroyed, and the Corporation may require the owner of the lost, stolen or destroyed certificate, or such owner’s legal representative, to give the Corporation a bond sufficient to indemnify it against any claim that may be made against it on account of the alleged loss, theft or destruction of any such certificate or the issuance of such new certificate or uncertificated shares.
7.5 CONSTRUCTION; DEFINITIONS.
Unless the context requires otherwise, the general provisions, rules of construction and definitions in the DGCL shall govern the construction of these bylaws. Without limiting the generality of this provision, the singular number includes the plural, the plural number includes the singular, and the term “person” includes both a corporation and a natural person.
7.6 DIVIDENDS.
The Board, subject to any restrictions contained in either (i) the DGCL or (ii) the Certificate of Incorporation, may declare and pay dividends upon the shares of its capital stock. Dividends may be paid in cash, in property or in shares of the Corporation’s capital stock.
The Board may set apart out of any of the funds of the Corporation available for dividends a reserve or reserves for any proper purpose and may abolish any such reserve. Such purposes shall include but not be limited to equalizing dividends, repairing or maintaining any property of the Corporation, and meeting contingencies.
7.7 FISCAL YEAR.
The fiscal year of the Corporation shall be fixed by resolution of the Board and may be changed by the Board.
7.8 SEAL.
The Corporation may adopt a corporate seal, which shall be adopted and which may be altered by the Board. The Corporation may use the corporate seal by causing it or a facsimile thereof to be impressed or affixed or in any other manner reproduced.
7.9 TRANSFER OF STOCK.
Shares of the Corporation shall be transferable in the manner prescribed by law and in these bylaws. Shares of stock of the Corporation shall be transferred on the books of the Corporation only by the holder of record thereof or by such holder’s attorney duly authorized in writing, upon surrender to the Corporation of the certificate or certificates representing such shares endorsed by the appropriate person or persons (or by delivery of duly executed instructions with respect to uncertificated shares), with such evidence of the authenticity of such endorsement or execution, transfer, authorization and other matters as the Corporation may reasonably require, and accompanied by all necessary stock transfer stamps. No transfer of stock shall be valid as against the Corporation for any purpose until it shall have been entered in the stock records of the Corporation by an entry showing the names of the persons from and to whom it was transferred.
7.10 STOCK TRANSFER AGREEMENTS.
The Corporation shall have power to enter into and perform any agreement with any number of stockholders of any one or more classes of stock of the Corporation to restrict the transfer of shares of stock of the Corporation of any one or more classes owned by such stockholders in any manner not prohibited by the DGCL.
7.11 REGISTERED STOCKHOLDERS.
The Corporation:
(i) 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;
(ii) shall be entitled to hold liable for calls and assessments the person registered on its books as the owner of shares; and
(iii) shall not be bound to recognize any equitable or other claim to or interest in such share or shares on the part of another person, whether or not it shall have express or other notice thereof, except as otherwise provided by the laws of Delaware.
7.12 WAIVER OF NOTICE.
Whenever notice is required to be given under any provision of the DGCL, the Certificate of Incorporation or these bylaws, a written waiver, signed by the person entitled to notice, or a waiver by electronic transmission by the person entitled to notice, whether before or after the time of the event for which notice is to be given, shall be deemed equivalent to notice. Attendance of a person at a meeting shall constitute a waiver of notice of such meeting, except when the person attends a meeting for the express purpose of objecting at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened. Neither the business to be transacted at, nor the purpose of, any regular or special meeting of the stockholders need be specified in any written waiver of notice or any waiver by electronic transmission unless so required by the Certificate of Incorporation or these bylaws.
ARTICLE VIII - NOTICE BY ELECTRONIC TRANSMISSION
8.1 NOTICE BY ELECTRONIC TRANSMISSION.
Without limiting the manner by which notice otherwise may be given effectively to stockholders pursuant to the DGCL, the Certificate of Incorporation or these bylaws, any notice to stockholders given by the Corporation under any provision of the DGCL, the Certificate of Incorporation or these bylaws shall be effective if given by a form of electronic transmission consented to by the stockholder to whom the notice is given. Any such consent shall be revocable by the stockholder by written notice to the Corporation. Any such consent shall be deemed revoked if:
(i) the Corporation is unable to deliver by electronic transmission two (2) consecutive notices given by the Corporation in accordance with such consent; and
(ii) such inability becomes known to the secretary or an assistant secretary of the Corporation or to the transfer agent, or other person responsible for the giving of notice.
However, the inadvertent failure to treat such inability as a revocation shall not invalidate any meeting or other action.
Any notice given pursuant to the preceding paragraph shall be deemed given:
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(i)
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if by facsimile telecommunication, when directed to a number at which the stockholder has consented to receive notice;
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(ii)
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if by electronic mail, when directed to an electronic mail address at which the stockholder has consented to receive notice;
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(iii)
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if by a posting on an electronic network together with separate notice to the stockholder of such specific posting, upon the later of (A) such posting and (B) the giving of such separate notice; and
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(iv)
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if by any other form of electronic transmission, when directed to the stockholder.
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An affidavit of the secretary or an assistant secretary or of the transfer agent or other agent of the Corporation that the notice has been given by a form of electronic transmission shall, in the absence of fraud, be prima facie evidence of the facts stated therein.
8.2 DEFINITION OF ELECTRONIC TRANSMISSION.
An “electronic transmission” means any form of communication, not directly involving the physical transmission of paper, that creates a record that may be retained, retrieved and reviewed by a recipient thereof, and that may be directly reproduced in paper form by such a recipient through an automated process.
ARTICLE IX - INDEMNIFICATION
9.1 INDEMNIFICATION OF DIRECTORS AND OFFICERS.
The Corporation shall indemnify and hold harmless, to the fullest extent permitted by the DGCL as it presently exists or may hereafter be amended, any director or officer of the Corporation who was or is made or is threatened to be made a party or is otherwise involved in any action, suit or proceeding, whether civil, criminal, administrative or investigative (a “
Proceeding
”) by reason of the fact that he or she, or a person for whom he or she is the legal representative, is or was a director or officer of the Corporation or is or was serving at the request of the Corporation as a director, officer, employee or agent of another corporation or of a partnership, joint venture, trust, enterprise or non-profit entity, including service with respect to employee benefit plans, against all liability and loss suffered and expenses (including attorneys’ fees) reasonably incurred by such person in connection with any such Proceeding. Notwithstanding the preceding sentence, except as otherwise provided in Section 9.4, the Corporation shall be required to indemnify a person in connection with a Proceeding initiated by such person only if the Proceeding was authorized in the specific case by the Board.
9.2 INDEMNIFICATION OF OTHERS.
The Corporation shall have the power to indemnify and hold harmless, to the extent permitted by applicable law as it presently exists or may hereafter be amended, any employee or agent of the Corporation who was or is made or is threatened to be made a party or is otherwise involved in any Proceeding by reason of the fact that he or she, or a person for whom he or she is the legal representative, is or was an 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 or of a partnership, joint venture, trust, enterprise or non-profit entity, including service with respect to employee benefit plans, against all liability and loss suffered and expenses reasonably incurred by such person in connection with any such Proceeding.
9.3 PREPAYMENT OF EXPENSES.
The Corporation shall to the fullest extent not prohibited by applicable law pay the expenses (including attorneys’ fees) incurred by any officer or director of the Corporation, and may pay the expenses incurred by any employee or agent of the Corporation, in defending any Proceeding in advance of its final disposition;
provided, however
, that, to the extent required by law, such payment of expenses in advance of the final disposition of the Proceeding shall be made only upon receipt of an undertaking by the person to repay all amounts advanced if it should be ultimately determined that the person is not entitled to be indemnified under this Article IX or otherwise.
9.4 DETERMINATION; CLAIM.
If a claim for indemnification (following the final disposition of such Proceeding) or advancement of expenses under this Article IX is not paid in full within sixty (60) days after a written claim therefor has been received by the Corporation the claimant may file suit to recover the unpaid amount of such claim and, if successful in whole or in part, shall be entitled to be paid the expense of prosecuting such claim to the fullest extent permitted by law. In any such action the Corporation shall have the burden of proving that the claimant was not entitled to the requested indemnification or payment of expenses under applicable law.
9.5 NON-EXCLUSIVITY OF RIGHTS.
The rights conferred on any person by this Article IX shall not be exclusive of any other rights which such person may have or hereafter acquire under any statute, provision of the Certificate of Incorporation, these bylaws, agreement, vote of stockholders or disinterested directors or otherwise.
9.6 INSURANCE.
The Corporation may purchase and maintain insurance on 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 enterprise or non-profit entity against any liability asserted against him or her and incurred by him or her in any such capacity, or arising out of his or her status as such, whether or not the Corporation would have the power to indemnify him or her against such liability under the provisions of the DGCL.
9.7 OTHER INDEMNIFICATION.
The Corporation’s obligation, if any, to indemnify or advance expenses to any person who was or is serving at its request as a director, officer, employee or agent of another corporation, partnership, joint venture, trust, enterprise or non-profit entity shall be reduced by any amount such person may collect as indemnification or advancement of expenses from such other corporation, partnership, joint venture, trust, enterprise or non-profit enterprise.
9.8 CONTINUATION OF INDEMNIFICATION.
The rights to indemnification and to prepayment of expenses provided by, or granted pursuant to, this Article IX shall continue notwithstanding that the person has ceased to be a director or officer of the Corporation and shall inure to the benefit of the estate, heirs, executors, administrators, legatees and distributees of such person.
9.9 AMENDMENT OR REPEAL.
The provisions of this Article IX shall constitute a contract between the Corporation, on the one hand, and, on the other hand, each individual who serves or has served as a director or officer of the Corporation (whether before or after the adoption of these bylaws), in consideration of such person’s performance of such services, and pursuant to this Article IX the Corporation intends to be legally bound to each such current or former director or officer of the Corporation. With respect to current and former directors and officers of the Corporation, the rights conferred under this Article IX are present contractual rights and such rights are fully vested, and shall be deemed to have vested fully, immediately upon adoption of theses bylaws. With respect to any directors or officers of the Corporation who commence service following adoption of these bylaws, the rights conferred under this provision shall be present contractual rights and such rights shall fully vest, and be deemed to have vested fully, immediately upon such director or officer commencing service as a director or officer of the Corporation. Any repeal or modification of the foregoing provisions of this Article IX shall not adversely affect any right or protection (i) hereunder of any person in respect of any act or omission occurring prior to the time of such repeal or modification or (ii) under any agreement providing for indemnification or advancement of expenses to an officer or director of the Corporation in effect prior to the time of such repeal or modification.
ARTICLE X - AMENDMENTS
Subject to the limitations set forth in Section 9.9 of these bylaws or the provisions of the certificate of incorporation, the Board is expressly empowered to adopt, amend or repeal the bylaws of the Corporation. Any adoption, amendment or repeal of the bylaws of the Corporation by the Board shall require the approval of a majority of the authorized number of directors. The stockholders also shall have power to adopt, amend or repeal the bylaws of the Corporation;
provided, however
, that, in addition to any vote of the holders of any class or series of stock of the Corporation required by law or by the Certificate of Incorporation, such action by stockholders shall require the affirmative vote of the holders of at least sixty-six and two-thirds percent (66-2/3%) of the voting power of all of the then-outstanding shares of the Voting Stock.
MENLO THERAPEUTICS INC.
SECOND AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT
THIS SECOND AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT (this “
Agreement
”) is made as of June 28, 2017, by and among Menlo Therapeutics Inc., a Delaware corporation (the “
Company
”) and the investors listed on
Schedule A
hereto (each an “
Investor
” and collectively the “
Investors
”).
RECITALS
Certain of the Investors are existing stockholders of the Company (the “
Prior Investors
”) and hold shares of Series A Preferred Stock of the Company (the “
Series A Preferred Stock
”) and/or shares of Series B Preferred Stock of the Company (the “
Series B Preferred Stock
”) and/or shares of Common Stock of the Company and are parties to that certain Amended and Restated Investors’ Rights Agreement, dated as of November 30, 2015, by and among the Company and such Prior Investors (the “
Prior Agreement
”) and constitute the Requisite Majority (as defined in the Prior Agreement).
Certain of the Investors and the Company are parties to that certain Series C Preferred Stock Purchase Agreement, dated as of the date hereof (the “
Series C Purchase Agreement
”) relating to the issue and sale of shares of Series C Preferred Stock of the Company (the “
Series C Preferred Stock
,” and together with the Series A Preferred Stock and the Series B Preferred Stock, the “
Preferred Stock
”).
The obligations of the Company and such Investors under the Series C Purchase Agreement are conditioned, among other things, upon the execution and delivery of this Agreement by such Investors, the Prior Investors and the Company and the Prior Investors and the Company desire to amend the restate the Prior Agreement as provided herein.
NOW, THEREFORE, in consideration of the mutual premises and covenants set forth herein, the Company and the Prior Investors hereby agree to amend and restate the Prior Agreement as set forth herein, and the parties hereto agree as follows:
1.
Registration Rights
. The Company covenants and agrees as follows:
1.1
Definitions
. For purposes of this Agreement:
(a)
The term “
Act
” means the Securities Act of 1933, as amended.
(a)
The term “
Affiliate
” means, with respect to any specified Person, any other Person who or which, directly or indirectly, controls, is controlled by, or is under common control with such specified Person, including, without limitation, any general partner, limited partner, member, managing member, officer, director, employee or manager of such Person and any venture capital fund or limited liability company now or hereafter existing that is controlled by one or more general partners or managing members of, or is under common investment management with, such Person. For purposes of the definition, (a) the term
“
control
” when used with respect to any Person shall mean the power to direct the management or policies of such Person, directly or indirectly, whether through ownership of voting securities, by contract or otherwise, and the terms “
controlling
” and “
controlled
” shall have meanings correlative to the foregoing, and (b) the term “
Person
” means any individual, partnership, limited liability company, joint venture, corporation, association, trust or any other entity or organization.
(b)
The term “
Free Writing Prospectus
” means a free-writing prospectus, as defined in Rule 405.
(c)
The term “
Form S‑3
” means such form under the Act as in effect on the date hereof or any registration form under the Act subsequently adopted by the SEC that permits inclusion or incorporation of substantial information by reference to other documents filed by the Company with the SEC.
(d)
The term “
Holder
” means any person owning or having the right to acquire Registrable Securities or any assignee thereof in accordance with Section 1.11 hereof.
(e)
The term “
Initial Offering
” means the Company’s first firm commitment underwritten public offering of its Common Stock under the Act.
(f)
The term “
1934 Act
” means the Securities Exchange Act of 1934, as amended.
(g)
The term “
Qualified Public Offering
” shall mean the first firm commitment underwritten public offering of securities of the Company pursuant to an effective registration statement under the Act (other than a registration statement relating either to the sale of securities to employees of the Company pursuant to a stock option, stock purchase or similar plan or an SEC (as defined below) Rule 145 transaction) at a price per share of not less than $6.38 (appropriately adjusted for recapitalizations, stock splits, stock dividends, combinations and the like (“
Recapitalizations
”) effected after the date hereof) and with gross proceeds (before deduction of commissions and expenses) to the Company of more than $40,000,000.
(h)
The terms “
register
,” “
registered
,” and “
registration
” refer to a registration effected by preparing and filing a registration statement or similar document in compliance with the Act, and the declaration or ordering of effectiveness of such registration statement or document.
(i)
The term “
Registrable Securities
” means (i) the Common Stock issuable or issued upon conversion of the Company’s Series A Preferred Stock, Series B Preferred Stock and Series C Preferred Stock, (ii) the Common Stock held by the Investors who are holders of Series A Preferred Stock and (iii) any Common Stock of the Company issued as (or issuable upon the conversion or exercise of any warrant, right or other security that is issued as) a dividend or other distribution with respect to, or in exchange for, or in replacement of, the shares referenced in (i) (ii) and (iii) above, excluding in all cases, however, any Registrable
Securities sold by a person in a transaction in which his rights under this Section 1 are not assigned.
(j)
The number of shares of Registrable Securities outstanding shall be determined by the number of shares of Common Stock outstanding that are, and the number of shares of Common Stock issuable pursuant to then exercisable or convertible securities that are, Registrable Securities.
(k)
The term “
Certificate of Incorporation
” shall mean the Company’s Certificate of Incorporation, as amended and/or restated from time to time.
(l)
The term “
Rule 144
” shall mean Rule 144 under the Act.
(m)
The term “
Rule 145
” shall mean Rule 145 under the Act.
(n)
The term “
SEC
” shall mean the Securities and Exchange Commission.
1.2
Request for Registration
.
(a)
Subject to the conditions of this Section 1.2, if the Company shall receive at any time after the earlier of (i) four (4) years after the date of this Agreement or (ii) six (6) months after the effective date of the Initial Offering, a written request from the Holders of at least fifty percent (50%) of the Registrable Securities outstanding (for purposes of this Section 1.2, the “
Initiating Holders
”) that the Company file a registration statement under the Act covering the registration of Registrable Securities with an anticipated aggregate offering price of at least $10,000,000, then the Company shall, within twenty (20) days of the receipt thereof, give written notice of such request to all Holders, and subject to the limitations of this Section 1.2, use its reasonable best efforts to, as soon as practicable, file a registration statement under the Act with respect to all of the Registrable Securities that the Holders request to be registered in a written request received by the Company within twenty (20) days of the mailing of the Company’s notice pursuant to this Section 1.2(a), and use reasonable best efforts to cause such registration statement to be declared effective by the SEC as soon as practicable.
(b)
If the Initiating Holders intend to distribute the Registrable Securities covered by their request by means of an underwriting, they shall so advise the Company as a part of their request made pursuant to this Section 1.2 and the Company shall include such information in the written notice referred to in Section 1.2(a). In such event the right of any Holder to include its Registrable Securities in such registration shall be conditioned upon such Holder’s participation in such underwriting and the inclusion of such Holder’s Registrable Securities in the underwriting (unless otherwise mutually agreed by a majority in interest of the Initiating Holders and such Holder) to the extent provided herein. All Holders proposing to distribute their securities through such underwriting shall enter into an underwriting agreement in customary form with the underwriter or underwriters selected for such underwriting by the Company (which underwriter or underwriters shall be reasonably acceptable to a majority in interest of the Initiating Holders). Notwithstanding any other provision of this Section 1.2, if
the underwriter advises the Company that marketing factors require a limitation on the number of securities underwritten (including Registrable Securities), then the Company shall so advise all Holders of Registrable Securities that would otherwise be underwritten pursuant hereto, and the number of shares that may be included in the underwriting shall be allocated to the Holders of such Registrable Securities pro rata based on the number of Registrable Securities held by all such Holders (including the Initiating Holders). In no event shall any Registrable Securities be excluded from such underwriting unless all other securities are first excluded. Any Registrable Securities excluded or withdrawn from such underwriting shall be withdrawn from the registration.
(c)
Notwithstanding the foregoing, the Company shall not be required to effect a registration pursuant to this Section 1.2:
(i)
in any particular jurisdiction in which the Company would be required to execute a general consent to service of process in effecting such registration, unless the Company is already subject to service in such jurisdiction and except as may be required under the Act; or
(ii)
after the Company has effected two (2) registrations pursuant to this Section 1.2, and such registrations have been declared or ordered effective; or
(iii)
during the period starting with the date of the filing of and ending on a date one hundred eighty (180) days following the effective date of a Company‑initiated registration subject to Section 1.3 below, provided that the Company is actively employing in good faith reasonable best efforts to cause such registration statement to become effective; or
(iv)
if the Initiating Holders propose to dispose of Registrable Securities that may be registered on Form S‑3 pursuant to Section 1.4 hereof; or
(v)
if the Company shall furnish to Holders requesting a registration statement pursuant to this Section 1.2 a certificate signed by the Company’s Chief Executive Officer or Chairman of the Board stating (A) that the Company intends to file a registration statement for its Initial Offering within one hundred twenty (120) days following the date of the initial request for registration made by the Initiating Holders pursuant to this Section 1.2 or (B) that in the good faith judgment of the Board of Directors of the Company, it would be seriously detrimental to the Company and its stockholders for such registration statement to be effected at such time, in which event the Company shall have the right to defer such filing for a period of not more than one hundred twenty (120) days after receipt of the request of the Initiating Holders, provided that such right shall be exercised by the Company not more than once in any twelve (12)‑month period and
provided
further
that the Company shall not register any securities for the account of itself or any other stockholder during such one hundred twenty (120) day period (other than a registration relating solely to the sale of securities of participants in a Company stock plan, a registration relating to a corporate reorganization or transaction under Rule 145 of the Act, a registration on any form that does not include substantially the same information as would be required to be included in a registration statement
covering the sale of the Registrable Securities, or a registration in which the only Common Stock being registered is Common Stock issuable upon conversion of debt securities that are also being registered).
1.3
Company Registration
.
(a)
If (but without any obligation to do so) the Company proposes to register (including for this purpose a registration effected by the Company for stockholders other than the Holders that has been expressly approved by the Holders pursuant to Section 1.12) any of its stock or other securities under the Act in connection with the public offering of such securities (other than a registration relating solely to the sale of securities of participants in a Company stock plan, a registration relating to a corporate reorganization or transaction under Rule 145 of the Act, a registration on any form that does not include substantially the same information as would be required to be included in a registration statement covering the sale of the Registrable Securities, or a registration in which the only Common Stock being registered is Common Stock issuable upon conversion of debt securities that are also being registered), the Company shall, at such time, promptly give each Holder written notice of such registration. Upon the written request of each Holder given within twenty (20) days after mailing of such notice by the Company in accordance with Section 1.3(c), the Company shall, subject to the provisions of Section 1.3(c), use reasonable best efforts to cause to be registered under the Act all of the Registrable Securities that each such Holder requests to be registered.
(b)
Right to Terminate Registration
. The Company shall have the right to terminate or withdraw any registration initiated by it under this Section 1.3 prior to the effectiveness of such registration whether or not any Holder has elected to include securities in such registration. The expenses of such withdrawn registration shall be borne by the Company in accordance with Section 1.7 hereof.
(c)
Underwriting Requirements
. In connection with any offering involving an underwriting of shares of the Company’s capital stock, the Company shall not be required under this Section 1.3 to include any of the Holders’ securities in such underwriting unless they accept the terms of the underwriting as agreed upon between the Company and the underwriters selected by the Company (or by other persons entitled to select the underwriters) and enter into an underwriting agreement in customary form with such underwriters, and then only in such quantity as the underwriters determine in their sole discretion will not jeopardize the success of the offering by the Company. If the total amount of securities, including Registrable Securities, requested by stockholders to be included in such offering exceeds the amount of securities sold other than by the Company that the underwriters determine in their sole discretion is compatible with the success of the offering, then the Company shall be required to include in the offering only that number of such securities, including Registrable Securities, that the underwriters determine in their sole discretion will not jeopardize the success of the offering. The Company shall not, without the prior written consent of the holders of at least a majority of the Registrable Securities then held by the Investors exclude any Registrable Securities from such offering unless all other stockholders’ securities have been first excluded. In the event that the underwriters determine that less than all of the Registrable Securities requested to be
registered can be included in such offering, then the Registrable Securities that are included in such offering shall be apportioned first, to the Company; second, to the Investors on a pro rata basis based on the total number of Registrable Securities held by such Investors; and third, to any stockholder of the Company (other than a Holder) on a
pro rata
basis so long as the number of Registrable Securities held by the Holders is not reduced. Notwithstanding the foregoing, in no event shall the amount of securities of the selling Investors included in the offering be reduced below thirty percent (30%) of the total amount of securities included in such offering, unless such offering is the initial public offering of the Company’s securities, in which case the selling Holders may be excluded if the underwriters make the determination described above and no other stockholder’s securities are included in such offering. For purposes of the preceding sentence concerning apportionment, for any selling stockholder that is a Holder of Registrable Securities and that is a venture capital fund, limited liability company, partnership or corporation, the affiliated venture capital funds, members, partners, retired partners and stockholders of such Holder together with any Affiliates of such Holder, or the estates and family members of any such partners and retired partners and any trusts for the benefit of any of the foregoing persons shall be deemed to be a single “selling Holder,” and any pro rata reduction with respect to such “selling Holder” shall be based upon the aggregate amount of Registrable Securities owned by all such related entities and individuals.
1.4
Form S‑3 Registration
. In case the Company shall receive from the Holders (for purposes of this Section 1.4, the “
Initiating Holders
”) a written request or requests that the Company effect a registration on Form S‑3 and any related qualification or compliance with respect to all or a part of the Registrable Securities owned by such Initiating Holder or Initiating Holders, the Company shall:
(a)
promptly give written notice of the proposed registration, and any related qualification or compliance, to all other Holders; and
(b)
use reasonable best efforts to effect, as soon as practicable, such registration and all such qualifications and compliances as may be so requested and as would permit or facilitate the sale and distribution of all or such portion of such Holders’ Registrable Securities as are specified in such request, together with all or such portion of the Registrable Securities of any other Holders joining in such request as are specified in a written request given within fifteen (15) days after receipt of such written notice from the Company, provided, however, that the Company shall not be obligated to effect any such registration, qualification or compliance, pursuant to this Section 1.4:
(i)
if Form S‑3 is not available for such offering by the Holders;
(ii)
if the Holders, together with the holders of any other securities of the Company entitled to inclusion in such registration, propose to sell Registrable Securities and such other securities (if any) at an aggregate price to the public (net of any underwriters’ discounts or commissions) of less than $1,000,000;
(iii)
if the Company shall furnish to Holders requesting a registration statement pursuant to this Section 1.4 a certificate signed by the Company’s Chief Executive Officer or Chairman of the Board stating that in the good faith judgment of the Board of Directors of the Company, it would be seriously detrimental to the Company and its stockholders for such registration statement to be effected at such time, in which event the Company shall have the right to defer such filing for a period of not more than ninety (90) days after receipt of the request of the Initiating Holders, provided that such right shall be exercised by the Company not more than once in any twelve (12)‑month period and
provided
further
that the Company shall not register any securities for the account of itself or any other stockholder during such ninety (90) day period (other than a registration relating solely to the sale of securities of participants in a Company stock plan, a registration relating to a corporate reorganization or transaction under Rule 145 of the Act, a registration on any form that does not include substantially the same information as would be required to be included in a registration statement covering the sale of the Registrable Securities, or a registration in which the only Common Stock being registered is Common Stock issuable upon conversion of debt securities that are also being registered);
(iv)
if the Company has, within the twelve (12) month period preceding the date of such request, already effected two registrations on Form S‑3 for the Holders pursuant to this Section 1.4; or
(v)
in any particular jurisdiction in which the Company would be required to qualify to do business or to execute a general consent to service of process in effecting such registration, qualification or compliance.
(c)
If the Initiating Holders intend to distribute the Registrable Securities covered by their request by means of an underwriting, they shall so advise the Company as a part of their request made pursuant to this Section 1.4 and the Company shall include such information in the written notice referred to in Section 1.4(a). The provisions of Section 1.2(b) shall be applicable to such request (with the substitution of Section 1.4 for references to Section 1.2).
(d)
Subject to the foregoing, the Company shall use reasonable best efforts to file a registration statement covering the Registrable Securities and other securities so requested to be registered as soon as practicable after receipt of the request or requests of the Initiating Holders. Registrations effected pursuant to this Section 1.4 shall not be counted as requests for registration effected pursuant to Sections 1.2.
1.5
Obligations of the Company
. Whenever required under this Section 1 to effect the registration of any Registrable Securities, the Company shall, as expeditiously as reasonably possible:
(a)
prepare and file with the SEC a registration statement with respect to such Registrable Securities and use reasonable best efforts to cause such registration statement to become effective, and, upon the request of the Holders of a majority of the Registrable Securities registered thereunder, keep such registration statement effective for a period of up to
ninety (90) days or, if earlier, until the distribution contemplated in the Registration Statement has been completed;
(b)
prepare and file with the SEC such amendments and supplements to such registration statement and the prospectus used in connection with such registration statement as may be necessary to comply with the provisions of the Act with respect to the disposition of all securities covered by such registration statement;
(c)
furnish to the Holders such number of copies of a prospectus, including a preliminary prospectus and any Free Writing Prospectus, in conformity with the requirements of the Act, and such other documents as they may reasonably request in order to facilitate the disposition of Registrable Securities owned by them;
(d)
use reasonable best efforts to register and qualify the securities covered by such registration statement under such other securities or Blue Sky laws of such jurisdictions as shall be reasonably requested by the Holders, provided that the Company shall not be required in connection therewith or as a condition thereto to qualify to do business or to file a general consent to service of process in any such states or jurisdictions;
(e)
in the event of any underwritten public offering, enter into and perform its obligations under an underwriting agreement, in usual and customary form, with the managing underwriter of such offering;
(f)
notify each Holder of Registrable Securities covered by such registration statement at any time when a prospectus or Free Writing Prospectus (to the extent prepared by or on behalf of the Company) relating thereto is required to be delivered under the Act of the happening of any event as a result of which the prospectus included in such registration statement, as then in effect, includes an untrue statement of a material fact or omits to state a material fact required to be stated therein or necessary to make the statements therein not misleading in the light of the circumstances then existing, and, at the request of any such Holder, the Company will, as soon as reasonably practicable, file and furnish to all such Holders a supplement or amendment to such prospectus or Free Writing Prospectus (to the extent prepared by or on behalf of the Company) so that, as thereafter delivered to the purchasers of such Registrable Securities, such prospectus will not contain an untrue statement of a material fact or omit to state any fact necessary to make the statements therein not misleading in light of the circumstances under which they were made;
(g)
cause all such Registrable Securities registered pursuant to this Section 1 to be listed on a national exchange or trading system and on each securities exchange and trading system on which similar securities issued by the Company are then listed;
(h)
provide a transfer agent and registrar for all Registrable Securities registered pursuant to this Agreement and a CUSIP number for all such Registrable Securities, in each case not later than the effective date of such registration; and
(i)
use reasonable best efforts to furnish, at the request of any Holder requesting registration of Registrable Securities pursuant to this Section 1, on the date that such Registrable Securities are delivered to the underwriters for sale in connection with a registration pursuant to this Section 1, if such securities are being sold through underwriters, or, if such securities are not being sold through underwriters, on the date that the registration statement with respect to such securities becomes effective, (i) an opinion, dated as of such date, of the counsel representing the Company for the purposes of such registration, and (ii) a “comfort” letter, dated as of such date, from the independent certified public accountants of the Company, in each case in form and substance as is customarily given to underwriters in an underwritten public offering and reasonably satisfactory to a majority in interest of the Holders requesting registration, addressed to the underwriters and to the Holders requesting registration of Registrable Securities.
Notwithstanding the provisions of this Section 1, the Company shall be entitled to postpone or suspend, for a reasonable period of time, the filing, effectiveness or use of, or trading under, any registration statement if the Company shall determine that any such filing or the sale of any securities pursuant to such registration statement would in the good faith unanimous judgment of the Board of Directors of the Company:
(i)
materially impede, delay or interfere with any material pending or proposed financing, acquisition, corporate reorganization or other similar transaction involving the Company for which the Board of Directors of the Company has authorized negotiations;
(ii)
materially adversely impair the consummation of any pending or proposed material offering or sale of any class of securities by the Company; or
(iii)
require disclosure of material nonpublic information that, if disclosed at such time, would be materially harmful to the interests of the Company and its stockholders;
provided
,
however
, that during any such period all executive officers and directors of the Company are also prohibited from selling securities of the Company (or any security of any of the Company’s subsidiaries or affiliates).
In the event of the suspension of effectiveness of any registration statement pursuant to this Section 1.5, the applicable time period during which such registration statement is to remain effective shall be extended by that number of days equal to the number of days the effectiveness of such registration statement was suspended.
1.6
Information from Holder
. It shall be a condition precedent to the obligations of the Company to take any action pursuant to this Section 1 with respect to the Registrable Securities of any selling Holder that such Holder shall furnish to the Company such information regarding itself, the Registrable Securities held by it, and the intended method of disposition of such securities as shall be reasonably required to effect the registration of such Holder’s Registrable Securities.
1.7
Expenses of Registration
. All expenses other than underwriting discounts and commissions incurred in connection with registrations, filings or qualifications pursuant to
Sections 1.2, 1.3 and 1.4, including (without limitation) all registration, filing and qualification fees, printers’ and accounting fees, fees and disbursements of counsel for the Company and the reasonable fees and disbursements not to exceed $35,000 of one counsel for the selling Holders shall be borne by the Company. Notwithstanding the foregoing, the Company shall not be required to pay for any expenses of any registration proceeding begun pursuant to Section 1.2 or Section 1.4 if the registration request is subsequently withdrawn at the request of the Holders of a majority of the Registrable Securities to be registered (in which case all participating Holders shall bear such expenses pro rata based upon the number of Registrable Securities that were to be included in the withdrawn registration), unless, in the case of a registration requested under Section 1.2 or Section 1.4, the Holders of at least a majority of the Registrable Securities then held by the Investors agree to forfeit their right to one demand registration pursuant to Section 1.2 or Section 1.4 and provided, however, that if at the time of such withdrawal, the Holders have learned of a material adverse change in the condition, business or prospects of the Company from that known to the Holders at the time of their request and have withdrawn the request with reasonable promptness following disclosure by the Company of such material adverse change, then the Holders shall not be required to pay any of such expenses and shall retain their rights pursuant to Section 1.2 and 1.4.
1.8
Delay of Registration
. No Holder shall have any right to obtain or seek an injunction restraining or otherwise delaying any such registration as the result of any controversy that might arise with respect to the interpretation or implementation of this Section 1.
1.9
Indemnification
. In the event any Registrable Securities are included in a registration statement under this Section 1:
(a)
To the extent permitted by law, the Company will indemnify and hold harmless each Holder, the partners, members, officers, directors and stockholders of each Holder, legal counsel and accountants for each Holder, any underwriter (as defined in the Act) for such Holder and each person, if any, who controls such Holder or underwriter within the meaning of the Act or the 1934 Act, against any losses, claims, damages or liabilities (joint or several) to which they may become subject under the Act, the 1934 Act, any state securities laws or any rule or regulation promulgated under the Act, insofar as such losses, claims, damages, or liabilities (or actions in respect thereof) arise out of or are based upon any of the following statements, omissions or violations (collectively a “
Violation
”): (i) any untrue statement or alleged untrue statement of a material fact contained in such registration statement, including any preliminary prospectus, final prospectus or Free Writing Prospectus contained therein or any amendments or supplements thereto, any issuer information (as defined in Rule 433 of the Act) filed or required to be filed pursuant to Rule 433(d) under the Act or any other document incident to such registration prepared by or on behalf of the Company or used or referred to by the Company, (ii) the omission or alleged omission to state in such registration statement a material fact required to be stated therein, or necessary to make the statements therein not misleading or (iii) any violation or alleged violation by the Company of the Act, the 1934 Act, any state securities laws or any rule or regulation promulgated under the Act, the 1934 Act or any state securities laws, and the Company will reimburse each such Holder, underwriter, controlling person or other aforementioned person for any legal or other expenses reasonably incurred by
them in connection with investigating or defending any such loss, claim, damage, liability or action as such expenses are incurred; provided, however, that the indemnity agreement contained in this subsection 1.9(a) shall not apply to amounts paid in settlement of any such loss, claim, damage, liability or action if such settlement is effected without the consent of the Company (which consent shall not be unreasonably withheld), nor shall the Company be liable in any such case with respect to a specific Holder for any such loss, claim, damage, liability or action to the extent that it arises out of or is based upon a Violation that occurs in reliance upon and in conformity with written information furnished expressly for use in connection with such registration by any such Holder, underwriter, controlling person or other aforementioned person.
(b)
To the extent permitted by law, each selling Holder, severally and not jointly, will indemnify and hold harmless the Company, each of its directors, each of its officers who has signed the registration statement, each person, if any, who controls the Company within the meaning of the Act, legal counsel and accountants for the Company, any underwriter, any other Holder selling securities in such registration statement and any controlling person of any such underwriter or other Holder, against any losses, claims, damages or liabilities (joint or several) to which any of the foregoing persons may become subject, under the Act, the 1934 Act, any state securities laws or any rule or regulation promulgated under the Act, the 1934 Act or any state securities laws, insofar as such losses, claims, damages or liabilities (or actions in respect thereto) arise out of or are based upon any Violation, in each case to the extent (and only to the extent) that such Violation occurs in reliance upon and in conformity with written information furnished by such Holder expressly for use in connection with such registration; and each such Holder will reimburse any person intended to be indemnified pursuant to this subsection 1.9(b) for any legal or other expenses reasonably incurred by such person in connection with investigating or defending any such loss, claim, damage, liability or action as such expenses are incurred; provided, however, that the indemnity agreement contained in this subsection 1.9(b) shall not apply to amounts paid in settlement of any such loss, claim, damage, liability or action if such settlement is effected without the consent of the Holder (which consent shall not be unreasonably withheld), and provided that in no event shall any indemnity under this subsection 1.9(b), when aggregated with any contribution obligation under Section 1.9(d), exceed the net proceeds from the offering received by such Holder.
(c)
Promptly after receipt by an indemnified party under this Section 1.9 of notice of the commencement of any action (including any governmental action) for which a party may be entitled to indemnification, such indemnified party will, if a claim in respect thereof is to be made against any indemnifying party under this Section 1.9, deliver to the indemnifying party a written notice of the commencement thereof and the indemnifying party shall have the right to participate in and, to the extent the indemnifying party so desires, jointly with any other indemnifying party similarly noticed, to assume the defense thereof with counsel mutually satisfactory to the parties; provided, however, that an indemnified party (together with all other indemnified parties that may be represented without conflict by one counsel) shall have the right to retain one separate counsel, with the fees and expenses to be paid by the indemnifying party, if representation of such indemnified party by the counsel retained by the indemnifying party would be inappropriate due to actual or potential differing interests between such indemnified party and any other party represented by such counsel in such proceeding. The
failure to deliver written notice to the indemnifying party within a reasonable time of the commencement of any such action, if prejudicial to its ability to defend such action, shall relieve such indemnifying party of liability to the indemnified party under this Section 1.9 to the extent of such prejudice, but the omission to so deliver written notice to the indemnifying party will not relieve it of any liability that it may have to any indemnified party otherwise than under this Section 1.9.
(d)
If the indemnification provided for in this Section 1.9 is held by a court of competent jurisdiction to be unavailable to an indemnified party with respect to any loss, liability, claim, damage or expense referred to herein, then the indemnifying party, in lieu of indemnifying such indemnified party hereunder, shall contribute to the amount paid or payable by such indemnified party as a result of such loss, liability, claim, damage or expense in such proportion as is appropriate to reflect the relative fault of the indemnifying party on the one hand and the indemnified party on the other hand in connection with the statements or omissions that resulted in such loss, liability, claim, damage or expense, as well as any other relevant equitable considerations; provided, however, that no contribution by any Holder, when combined with any amounts paid by such Holder pursuant to Section 1.9(b), shall exceed the net proceeds from the offering received by such Holder. The relative fault of the indemnifying party and the indemnified party 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 indemnifying party or by the indemnified party and the parties’ relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission.
(e)
Notwithstanding the foregoing, to the extent that the provisions on indemnification and contribution contained in the underwriting agreement entered into in connection with the underwritten public offering are in conflict with the foregoing provisions, the provisions in the underwriting agreement shall control.
(f)
The obligations of the Company and Holders under this Section 1.9 shall survive the completion of any offering of Registrable Securities in a registration statement under this Section 1 and otherwise.
1.10
Reports Under the 1934 Act
. With a view to making available to the Holders the benefits of Rule 144 and any other rule or regulation of the SEC that may at any time permit a Holder to sell securities of the Company to the public without registration or pursuant to a registration on Form S‑3, the Company agrees to:
(a)
make and keep public information available, as those terms are understood and defined in Rule 144, at all times after the effective date of the Initial Offering;
(b)
file with the SEC in a timely manner all reports and other documents required of the Company under the Act and the 1934 Act; and
(c)
furnish to any Holder, so long as the Holder owns any Registrable Securities, forthwith upon request (i) a written statement by the Company that it has complied
with the reporting requirements of Rule 144 (at any time after ninety (90) days after the effective date of the first registration statement filed by the Company), the Act and the 1934 Act (at any time after it has become subject to such reporting requirements), or that it qualifies as a registrant whose securities may be resold pursuant to Form S‑3 (at any time after it so qualifies), (ii) a copy of the most recent annual or quarterly report of the Company and such other reports and documents so filed by the Company, and (iii) such other information as may be reasonably requested to avail any Holder of any rule or regulation of the SEC that permits the selling of any such securities without registration or pursuant to such form.
1.11
Assignment of Registration Rights
. The rights to cause the Company to register Registrable Securities pursuant to this Section 1 may be assigned (but only with all related obligations) by a Holder to a transferee or assignee of such securities that (i) is an Affiliate, member, subsidiary, parent, partner, limited partner, retired partner or stockholder of a Holder, (ii) is a Holder’s family member or trust for the benefit of an individual Holder, or (iii) after such assignment or transfer, holds at least 350,000 shares of Registrable Securities (subject to appropriate adjustment for Recapitalizations), provided: (a) the Company is, within a reasonable time after such transfer, furnished with written notice of the name and address of such transferee or assignee and the securities with respect to which such registration rights are being assigned; (b) such transferee or assignee agrees in writing to be bound by and subject to the terms and conditions of this Agreement, including, without limitation, the provisions of Section 2 below; and (c) such assignment shall be effective only if immediately following such transfer the further disposition of such securities by the transferee or assignee is restricted under the Act.
1.12
Limitations on Subsequent Registration Rights
. From and after the date of this Agreement, the Company shall not, without the prior written consent of the Investors holding at least a majority of the then outstanding Registrable Securities, enter into any agreement with any holder or prospective holder of any securities of the Company that would allow such holder or prospective holder (a) to include any of such securities in any registration filed under Section 1.2, 1.3 or 1.4 hereof, unless under the terms of such agreement, such holder or prospective holder may include such securities in any such registration only to the extent that the inclusion of such securities will not reduce the amount of the Registrable Securities of the Holders that are included, (b) to demand registration of their securities or (c) to exercise other registration rights that are pari passu or senior to those granted to the Holders hereunder.
1.13
Termination of Registration Rights
. No Holder shall be entitled to exercise any right provided for in this Section 1 (a) after five (5) years following the consummation of the Qualified Public Offering, (b) as to any Holder, such earlier time after the Qualified Public Offering at which all Registrable Securities held by such Holder (together with any Affiliate of the Holder with whom such Holder must aggregate its sales under Rule 144) can be sold in any ninety (90) day period without registration in compliance with Rule 144 or (c) upon the consummation of a transaction or series of related transactions which are deemed to be a liquidation, dissolution or winding up of the Company pursuant to the Certificate of Incorporation.
2.
“Market Stand-Off” Agreement
.
2.1
Each Holder hereby agrees that it will not, without the prior written consent of the managing underwriter, during the period commencing on the date of the final prospectus relating to the Company’s Initial Offering and ending on the date specified by the Company and the managing underwriter (such period not to exceed one hundred eighty (l80) days plus such additional period as may reasonably be requested by the Company or such underwriter to accommodate regulatory restrictions on (i) the publication or other distribution of research reports or (ii) analyst recommendations and opinions, including (without limitation) the restrictions set forth in FINRA Rule 2241 or any similar successor rules) (i) lend, offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any shares of Common Stock or any securities convertible into or exercisable or exchangeable for Common Stock held immediately
prior to the effectiveness of the Registration Statement for such offering, 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 the Common Stock, whether any such transaction described in clause (i) or (ii) above is to be settled by delivery of Common Stock or other securities, in cash or otherwise. The foregoing provisions of this Section 2.1 shall not apply to the sale of any shares to an underwriter pursuant to an underwriting agreement, and shall only be applicable to the Holders if all officers, directors and greater than one percent (1%) stockholders of the Company enter into similar agreements. The underwriters in connection with the Company’s Initial Offering are intended third party beneficiaries of this Section 2.1 and shall have the right, power and authority to enforce the provisions hereof as though they were a party hereto. Each Holder further agrees to execute such agreements as may be reasonably requested by the underwriters in the Company’s Initial Offering that are consistent with this Section 2.1 or that are necessary to give further effect thereto.
In order to enforce the foregoing covenant, the Company may impose stop transfer instructions with respect to the Registrable Securities of each Holder (and the shares or securities of every other person subject to the foregoing restriction) until the end of such period.
2.2
Each Holder agrees that a legend reading substantially as follows shall be placed on all certificates representing all Registrable Securities of each Holder (and the shares or securities of every other person subject to the restriction contained in this Section 2):
THE SECURITIES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO A LOCK-UP PERIOD OF UP TO 180 DAYS AFTER THE EFFECTIVE DATE OF THE ISSUER’S REGISTRATION STATEMENT FILED UNDER THE ACT, AS AMENDED, AS SET FORTH IN AN AGREEMENT BETWEEN THE COMPANY AND THE ORIGINAL HOLDER OF THESE SECURITIES, A COPY OF WHICH MAY BE OBTAINED AT THE ISSUER’S PRINCIPAL OFFICE. SUCH LOCK-UP PERIOD IS BINDING ON TRANSFEREES OF THESE SHARES.
3.
Covenants of the Company
.
3.1
Delivery of Financial Statements
. The Company shall deliver to each Investor that continues to hold at least 20,000 shares of Registrable Securities (each a “
Major Investor
”) (appropriately adjusted for any Recapitalizations):
(a)
as soon as practicable, but in any event within one hundred twenty (120) days after the end of each fiscal year of the Company, or such longer time as approved by the Board of Directors of the Company, an audited income statement for such fiscal year, an audited balance sheet of the Company and statement of stockholder’s equity as of the end of such year, and an audited statement of cash flows for such year, all such financial statements audited and certified by independent public accountants of nationally recognized standing selected by the Company;
(b)
as soon as practicable, but in any event within forty-five (45) days after the end of each of the first three (3) quarters of each fiscal year of the Company, an unaudited income statement, statement of cash flows for such fiscal quarter and an unaudited balance sheet as of the end of such fiscal quarter, all prepared in accordance with generally accepted accounting principles in the United Stated (“
GAAP
”) (except that such financial statements may (i) be subject to normal year-end audit adjustments; and (ii) not contain all notes thereto that may be required in accordance with GAAP);
(c)
within thirty (30) days prior to the beginning of each fiscal year, a budget and business plan for the next fiscal year, prepared on a monthly basis, including balance sheets, income statements and statements of cash flows for such months and, as soon as prepared, any other budgets or revised budgets prepared by the Company;
(d)
as soon as practicable, but in any event within forty-five (45) days after the end of each of the first three (3) quarters of each fiscal year of the Company, a statement showing the number of shares of each class and series of capital stock and securities convertible into or exercisable for shares of capital stock outstanding at the end of the period (including a description of such capital stock and exchange ratio or exercise price applicable thereto) and the number of shares of issued options and options not yet issued but reserved for issuance, if any, all in sufficient detail as to permit the Major Investors to calculate their respective percentage equity ownership in the Company;
(e)
as soon as practicable, but in any event thirty (30) days before the end of each fiscal year (or at such other time as approved by the Board of Directors), a budget and business plan for the next fiscal year (collectively, the “
Budget
”), approved by the Board of Directors and prepared on a monthly basis, including balance sheets, income statements, and statements of cash flow for such months and, promptly after prepared, any other budgets or revised budgets prepared by the Company; and
(f)
such other information relating to the financial condition, business, prospects, or corporate affairs of the Company as any Major Investor may from time to time reasonably request; provided, however, that the Company shall not be obligated under this
Section 3.1 to provide information (i) that the Company reasonably determines in good faith to be a trade secret or confidential information (unless covered by an enforceable confidentiality agreement, in a form acceptable to the Company); or (ii) the disclosure of which would adversely affect the attorney-client privilege between the Company and its counsel.
3.2
Inspection
. The Company shall permit each Investor that continues to hold shares of capital stock of the Company, at such Investor’s expense, and upon reasonable notice, during normal business hours, to visit and inspect the Company’s properties, to examine its books of account and records and to discuss the Company’s affairs, finances and accounts with its officers, all at such reasonable times as may be reasonably requested by the Investor; provided, however, that the Company shall not be obligated pursuant to this Section 3.2 to provide access to any information that it reasonably and in good faith considers to be a trade secret or similar confidential information or the disclosure of which would adversely affect the attorney-client privilege between the Company and its counsel.
3.3
Confidentiality
. Each Investor acknowledges that the information received by them pursuant to this Agreement may be confidential and for its use only, and it will not use such confidential information in violation of the Exchange Act or reproduce, disclose or disseminate such information to any other person (other than its employees or agents having a need to know the contents of such information, and its attorneys), except in connection with the exercise of rights under this Agreement; provided however, such Investor may disclose such proprietary or confidential information (i) to its attorneys, accountants, consultants, and other professionals to the extent necessary to obtain their services in connection with monitoring its investment in the Company, (ii) to any existing or prospective partner, affiliate, member, employee, stockholder or subsidiary or parent of such Investor as long as such partner, member, employee, stockholder, subsidiary or parent is advised of and agrees or has agreed to be bound by the confidentiality provisions of this Section 3.3 or comparable restrictions; (iii) at such time as it enters the public domain through no fault of such Investor; (iv) that is communicated to it free of any obligation of confidentiality; (v) that is developed by Investor or its agents independently of and without reference to any confidential information communicated by the Company; or (vi) as required by applicable law.
3.4
Right of First Offer
. Subject to the terms and conditions specified in this Section 3.4, the Company hereby grants to each Investor holding at least 705,300 shares of Series B Preferred Stock or 350,000 shares of Series C Preferred Stock (each as appropriately adjusted for any Recapitalizations) (an “
Eligible Investor
”) a right of first offer with respect to future sales by the Company of its Shares (as hereinafter defined). For purposes of this Section 3.4, Eligible Investor includes any general partners, members and Affiliates of an Eligible Investor. An Eligible Investor shall be entitled to apportion the right of first offer hereby granted it among itself and its partners, members and Affiliates in such proportions as it deems appropriate, so long as such apportionment does not cause the loss of the exemption under Section 4(2) of the Act or any similar exemption under applicable state securities laws in connection with such sale of Shares by the Company.
Each time the Company proposes to offer any shares of, or securities convertible into or exchangeable or exercisable for any shares of, any class of its capital stock (the “
Shares
”), the Company shall first make an offering of such Shares to each Eligible Investor in accordance with the following provisions:
(a)
The Company shall deliver a notice in accordance with Section 5.6 (the “
Notice
”) to the Eligible Investors stating (i) its bona fide intention to offer such Shares, (ii) the number of such Shares to be offered, and (iii) the price, terms and conditions upon which it proposes to offer such Shares.
(b)
By written notification received by the Company, within twenty-five (25) calendar days after receipt of the Notice, each Eligible Investor may elect to purchase or obtain, at the price and on the terms specified in the Notice, up to that portion of such Shares that equals the proportion that the number of shares of Common Stock issued and held, or issuable upon conversion of the Preferred Stock held by such Eligible Investor bears to the total number of shares of Common Stock of the Company then outstanding (assuming full conversion and exercise of all outstanding convertible and exercisable securities). The Company shall promptly, in writing, inform each Eligible Investor which purchases all the shares available to it (“
Fully-Exercising Eligible Investor
”) of any other Investor’s failure to do likewise. During the ten (10) day period commencing after receipt of such information, each Fully-Exercising Eligible Investor shall be entitled to obtain that portion of the Shares for which Eligible Investors were entitled to subscribe but which were not subscribed for by the Eligible Investors that is equal to the proportion that the number of shares of Common Stock issued and held, or issuable upon the conversion of Preferred Stock then held, by such Fully-Exercising Eligible Investor bears to the total number of shares of Common Stock issued and held, or issuable upon conversion of Preferred Stock then held, by all Fully-Exercising Eligible Investors who wish to purchase some of the unsubscribed shares.
(c)
If all Shares that Eligible Investors are entitled to obtain pursuant to Section 3.4(b) are not elected to be obtained as provided in Section 3.4(b) hereof, the Company may, during the ninety (90) day period following the expiration of the period provided in Section 3.4(b) hereof, offer the remaining unsubscribed portion of such Shares to any person or persons at a price not less than, and upon terms no more favorable to the offeree than those specified in the Notice. If the Company does not enter into an agreement for the sale of the Shares within such period, or if such agreement is not consummated within thirty (30) days of the execution thereof, the right provided hereunder shall be deemed to be revived and such Shares shall not be offered unless first reoffered to the Eligible Investors in accordance herewith.
(d)
The right of first offer in this Section 3.4 shall not be applicable to (i) the issuance or sale of Series C Shares to Series C Investors in accordance with the Series C Purchase Agreement, (ii) Exempted Securities (as defined in the Certificate of Incorporation), and (iii) shares of Common Stock issued in the Initial Offering;
In addition to the foregoing, the right of first offer in this Section 3.4 shall not be applicable with respect to any Eligible Investor and any subsequent securities issuance, if (i) at the time of such subsequent securities issuance, the Eligible Investor is not an “accredited investor,” as that term
is then defined in Rule 501(a) under the Act, and (ii) such subsequent securities issuance is otherwise being offered only to accredited investors.
(e)
The right of first offer set forth in this Section 3.4 may not be assigned or transferred, except that such right may be assigned (but only with all related obligations) by a Holder to a transferee or assignee of such securities that (i) is an Affiliate, subsidiary, parent, partner, limited partner, retired partner, member or stockholder of a Holder, (ii) is a Holder’s family member or trust for the benefit of an individual Holder, or (iii) after such assignment or transfer, holds at least 350,000 shares of Registrable Securities (subject to appropriate adjustment for Recapitalizations).
3.5
Proprietary Information and Inventions Agreements
. The Company shall require all of its employees and consultants to enter into the Company’s standard form of proprietary information and inventions agreement.
3.6
Expenses of Board Members
. The Company shall reimburse all non-employee directors for their reasonable out of pocket expenses related to (i) attending meetings of the Board of Directors of the Company and any committees thereof, and (ii) attending any other events at the express request of the Company, in each case in accordance with the Company’s travel policy.
3.7
Observer Rights
. The Company shall invite one representative of Vivo Capital Fund VIII, L.P. or its Affiliates (collectively, “
Vivo
”) and one representative of Merck Sharp & Dohme Corp. to attend all meetings of its Board of Directors in a nonvoting observer capacity and, in this respect, shall give each such representative copies of all notices, minutes, consents, and other materials that it provides to its directors at the same time and in the same manner as provided to such directors;
provided, however
, that each such representative shall agree to hold in confidence and trust and to act in a fiduciary manner with respect to all information so provided; and
provided further
, that the Company reserves the right to withhold any information and to exclude any such representative from any meeting or portion thereof if access to such information or attendance at such meeting could adversely affect the attorney-client privilege between the Company and its counsel or result in a conflict of interest.
3.8
Termination of Certain Covenants
. The covenants set forth in this Section 3 (other than Section 3.3) shall terminate and be of no further force or effect upon the consummation of the Initial Offering or at such time as the Company is required to file reports pursuant to Section 13 or 15(d) of the 1934 Act. This Agreement shall terminate and be of no further force or effect upon the consummation of a transaction or series of related transactions which are deemed to be “
Liquidation Event
” pursuant to the Certificate of Incorporation.
4.
Additional Covenants
.
Insurance
. The Company shall use its commercially reasonable efforts to obtain, within ninety (90) days of the date hereof, from financially sound and reputable insurers Directors and Officers liability insurance, in an amount and on terms and conditions satisfactory to the Board of Directors, including a majority of the Preferred Directors (as defined in the Certificate of Incorporation), and will use commercially reasonable efforts to cause such insurance policies to be maintained until such time as the Board of Directors,
including a majority of the Preferred Directors, determines that such insurance should be discontinued.
4.3
Employee Stock
. Unless otherwise approved by the Board of Directors, including a majority of the Preferred Directors, all future employees and consultants of the Company who purchase, receive options to purchase, or receive awards of shares of the Company’s capital stock after the date hereof shall be required to execute restricted stock or option agreements, as applicable, providing for (i) vesting of shares over a four (4) year period, with the first twenty-five percent (25%) of such shares vesting following twelve (12) months of continued employment or service, and the remaining shares vesting in equal monthly installments over the following thirty-six (36) months, and (ii) a market stand-off provision substantially similar to that in Section 2.1. In addition, unless otherwise approved by the Board of Directors, including a majority of the Preferred Directors, the Company shall retain a “right of first refusal” on employee transfers until the Company’s Initial Offering and shall have the right to repurchase unvested shares at cost upon termination of employment of a holder of restricted stock.
Qualified Small Business Stock
. The Company shall use commercially reasonable efforts to cause the shares of Series C Preferred Stock issued pursuant to the Series C Purchase Agreement, as well as any shares into which such shares are converted, within the meaning of Section 1202(f) of the Internal Revenue Code (the “
Code
”), to constitute “qualified small business stock” as defined in Section 1202(c) of the Code;
provided
,
however
, that such requirement shall not be applicable if the Board of Directors of the Company determines, in its good-faith business judgment, that such qualification is inconsistent with the best interests of the Company. The Company shall submit to its stockholders (including the Investors) and to the Internal Revenue Service any reports that may be required under Section 1202(d)(1)(C) of the Code and the regulations promulgated thereunder. In addition, within twenty (20) business days after any Investor’s written request therefor, the Company shall, at its option, either (i) deliver to such Investor a written statement indicating whether (and what portion of) such Investor’s interest in the Company constitutes “qualified small business stock” as defined in Section 1202(c) of the Code or (ii) deliver to such Investor such factual information in the Company’s possession as is reasonably necessary to enable such Investor to determine whether (and what portion of) such Investor’s interest in the Company constitutes “qualified small business stock” as defined in Section 1202(c) of the Code.
5.
Miscellaneous
.
5.1
Successors and Assigns
. Except as otherwise provided herein, the terms and conditions of this Agreement shall inure to the benefit of and be binding upon the respective successors and assigns of the parties (including transferees of any shares of Registrable Securities). Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement.
5.2
Governing Law; Venue
. This Agreement is to be construed in accordance with and governed by the internal laws of the State of Delaware without giving effect to any
choice of law rule that would cause the application of the laws of any jurisdiction other than the internal laws of the State of Delaware to the rights and duties of the parties. All disputes and controversies arising out of or in connection with this Agreement shall be resolved exclusively by the state and federal courts located in San Francisco County in the State of California, and each party hereto agrees to submit to the jurisdiction of said courts and agrees that venue shall lie exclusively with such courts.
5.3
Specific Enforcement
. Each party hereto agrees that its obligations hereunder are necessary and reasonable in order to protect the other parties to this Agreement, and each party expressly agrees and understands that monetary damages would inadequately compensate an injured party for the breach of this Agreement by any party, that this Agreement shall be specifically enforceable, and that, in addition to any other remedies that may be available at law, in equity or otherwise, any breach or threatened breach of this Agreement shall be the proper subject of a temporary or permanent injunction or restraining order, without the necessity of proving actual damages. Further, each party hereto waives any claim or defense that there is an adequate remedy at law for such breach or threatened breach.
5.4
Counterparts
. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
5.5
Titles and Subtitles
. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.
5.6
Notices
. Except as may be otherwise provided herein, all notices, requests, waivers and other communications made pursuant to this Agreement shall be in writing and shall be conclusively deemed to have been duly given (a) when hand delivered to the other party; (b) when sent by facsimile to the number set forth below if sent between 8:00 a.m. and 5:00 p.m. recipient’s local time on a business day, or on the next business day if sent by facsimile to the number set forth below if sent other than between 8:00 a.m. and 5:00 p.m. recipient’s local time on a business day, or when sent by electronic mail to the address set forth below if sent between 8:00 am and 5:00 pm recipient’s local time on a business day, or on the next business day if sent by electronic mail other than between 8:00 am and 5:00 pm recipient’s local time; (c) three business days after deposit in the U.S. mail with first class or certified mail receipt requested postage prepaid and addressed to the other party at the address set forth below; or (d) the next business day after deposit with a national overnight delivery service, postage prepaid, addressed to the parties as set forth below with next business day delivery guaranteed, provided that the sending party receives a confirmation of delivery from the delivery service provider. Subject to the limitations set forth in Delaware General Corporation Law §232(e), each Investor that is party hereto consents to the delivery of any notice to stockholders given by the Company under the Delaware General Corporation Law or the Certificate of Incorporation or bylaws (as amended from time to time) by (i) facsimile telecommunication to the facsimile number set forth below (or to any other facsimile number for such stockholder in the Company’s records), (ii) electronic mail to the electronic mail address set forth below (or to any other
electronic mail address for such Investor in the Company’s records), (iii) posting on an electronic network together with separate notice to the stockholder of such specific posting, or (iv) any other form of “electronic transmission” (as defined in the Delaware General Corporation Law) directed to the Investor. This consent may be revoked by an Investor by written notice to the Company and may be deemed revoked in the circumstances specified in Delaware General Corporation Law §232. Each person making a communication hereunder by facsimile or electronic mail shall promptly attempt to confirm by telephone to the person to whom such communication was addressed each communication made by it by facsimile or electronic mail pursuant hereto but the absence of such confirmation shall not affect the validity of any such communication. A party may change or supplement the addresses given above, or designate additional addresses, for purposes of this Section 5.6 by giving the other party written notice of the new address in the manner set forth above.
5.7
Expenses
. If any action at law or in equity is necessary to enforce or interpret the terms of this Agreement, the prevailing party shall be entitled to reasonable attorney’s fees, costs and necessary disbursements in addition to any other relief to which such party may be entitled.
5.8
Amendments and Waivers
. Any term of this Agreement may be amended and the observance of any term of this Agreement may be waived (either generally or in a particular instance and either retroactively or prospectively), only with the written consent of the Company and the Requisite Majority (as defined in the Certificate of Incorporation);
provided
,
however
, that if any amendment or waiver operates in a manner that treats any Investor differently from other Investors, the consent of such Investor shall also be required for such amendment or waiver, and
provided further
, that additional parties who are purchasers of Common Stock or Preferred Stock of the Company may become parties to this Agreement by executing a counterpart signature page hereto, without any amendment of this Agreement. Any amendment or waiver effected in accordance with this paragraph shall be binding upon each Investor and the Company. Notwithstanding anything to the contrary herein, any amendment, waiver or termination of Section 3.7 that affects Vivo shall require the prior consent of Vivo.
5.9
Future Stockholders
. The Company may at its option permit future holders of at least two percent (2%) of the Company’s Common Stock (assuming full conversion and exercise of all convertible and exercisable securities then outstanding) to enter into this Agreement and be subject to the terms and conditions hereof as an Investor. The parties hereby agree that such future holders may become parties to this Agreement by executing a counterpart of this Agreement, without any amendment of this Agreement.
5.10
Severability
. If one or more provisions of this Agreement are held to be unenforceable under applicable law, such provision shall be excluded from this Agreement and the balance of the Agreement shall be interpreted as if such provision were so excluded and shall be enforceable in accordance with its terms.
5.11
Aggregation of Stock
. All shares of Registrable Securities held or acquired by entities advised by the same investment adviser and affiliated entities or persons
shall be aggregated together for the purpose of determining the availability of any rights under this Agreement.
5.12
Entire Agreement
. This Agreement and the documents referred to herein constitute the entire agreement among the parties with respect to the subject matter hereof and no party shall be liable or bound to any other party in any manner by any warranties, representations or covenants except as specifically set forth herein or therein.
5.13
Waiver of Right of First Offer
. Solely for purposes of the transactions contemplated by the Series C Purchase Agreement, the right of first offer set forth in Section 3.4 of the Prior Agreement is hereby waived in its entirety, except to the extent of the Prior Investors’ purchases, if any, of Series C Preferred Stock pursuant to the Series C Purchase Agreement.
* * *
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first above written.
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COMPANY:
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MENLO THERAPEUTICS INC.
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By:
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/s/ Steven L. Basta
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Name:
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Steven L. Basta
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Title:
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Chief Executive Officer
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Address:
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[***]
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Facsimile:
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Email:
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[***]
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SIGNATURE PAGE TO
SECOND AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first above written.
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INVESTOR:
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PRESIDIO PARTNERS 2007, L.P.
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By:
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Presidio Partners 2007 GP, L.P.
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Its:
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General Partner
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By:
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/s/ David Collier
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Name:
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David Collier
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Title:
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General Partner
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Address:
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[***]
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Facsimile:
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[***]
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Email:
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[***]
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SIGNATURE PAGE TO
SECOND AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first above written.
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INVESTOR:
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PRESIDIO PARTNERS 2007 (PARALLEL) , L.P.
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By:
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Presidio Partners 2007 GP, L.P.
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Its:
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General Partner
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By:
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/s/ David Collier
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Name:
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David Collier
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Title:
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General Partner
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Address:
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[***]
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Facsimile:
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[***]
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Email:
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[***]
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SIGNATURE PAGE TO
SECOND AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first above written.
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INVESTOR:
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REMEDITEX VENTURES, LLC
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By:
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/s/ John W. Creecy
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Name:
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John W. Creecy
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Title:
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CEO
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Address:
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[***]
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Facsimile:
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[***]
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Email:
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[***]
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SIGNATURE PAGE TO
SECOND AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written.
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INVESTOR:
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VIVO CAPITAL FUND VIII, L.P.
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By:
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Vivo Capital VIII, LLC
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Its:
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General Partner
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By:
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/s/ Albert Cha
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Name:
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Albert Cha
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Title:
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Managing Member
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Address:
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[***]
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Facsimile:
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[***]
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Email:
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[***]
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SIGNATURE PAGE TO
SECOND AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written.
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INVESTOR:
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VIVO CAPITAL FUND VIII, L.P.
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By:
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Vivo Capital VIII, LLC
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Its:
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General Partner
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By:
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/s/ Albert Cha
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Name:
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Albert Cha
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Title:
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Managing Member
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Address:
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[***]
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Facsimile:
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[***]
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Email:
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[***]
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SIGNATURE PAGE TO
SECOND AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written.
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INVESTOR:
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F-PRIME CAPITAL PARTNERS HEALTHCARE
FUND IV LP
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By:
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F-Prime Capital Partners Healthcare Advisors
Fund IV LP
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Its:
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General Partner
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By:
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Impresa Holdings LLC
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Its:
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General Partner
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By:
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Impresa Management LLC
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Its:
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Managing Member
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By:
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/s/ Mary Bevelock Pendergast
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Name:
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Mary Bevelock Pendergast
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Title:
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Vice President
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Address:
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[***]
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Facsimile:
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[***]
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Email:
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[***]
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SIGNATURE PAGE TO
SECOND AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written.
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INVESTOR:
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VENBIO GLOBAL STRATEGIC FUND II, L.P.
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By:
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venBio Global Strategic GP II, L.P.
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Its:
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General Partner
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By:
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venBio Global Strategic GP II, Ltd.
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Its:
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General Partner
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By:
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/s/ Rob Adelman
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Name:
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Rob Adelman
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Title:
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Director
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Address:
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[***]
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Facsimile:
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[***]
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Email:
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[***]
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SIGNATURE PAGE TO
SECOND AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written.
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INVESTOR:
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NOVO HOLDINGS A/S (FKA NOVO A/S)
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By:
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/s/ Thomas Dyrberg by specific power of attorney
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Name:
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Thomas Dyrberg by specific power of attorney
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Title:
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Managing Partner Novo Ventures
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Address:
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[***]
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Facsimile:
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Email:
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[***]
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SIGNATURE PAGE TO
SECOND AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written.
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INVESTOR:
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ROCK SPRINGS CAPITAL MASTER FUND LP
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By:
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Rock Springs General Partner LLC
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By:
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/s/ Mark Bussard
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Name:
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Mark Bussard
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Title:
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Managing Member
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Address:
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[***]
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Facsimile:
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[***]
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Email:
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[***]
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[***]
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SIGNATURE PAGE TO
SECOND AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written.
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INVESTOR:
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ROCK SPRINGS CAPITAL MASTER FUND LP
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By:
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Bay City Capital GF XINDE Investment
Management Co.
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Its:
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General Partner
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By:
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/s/ Fred Craves
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Name:
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Fred Craves
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Title:
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Director
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Address:
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[***]
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Facsimile:
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[***]
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Email:
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[***]
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SIGNATURE PAGE TO
SECOND AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written.
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INVESTOR:
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AISLING CAPITAL IV, L.P.
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By:
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/s/ Robert Wenzel
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Name:
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Robert Wenzel
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Title:
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CFO
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Address:
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[***]
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Facsimile:
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[***]
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Email:
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SIGNATURE PAGE TO
SECOND AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT
SCHEDULE A
SCHEDULE OF INVESTORS
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Presidio Partners 2007, L.P.
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Presidio Partners 2007 (Parallel), L.P.
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Velocity Pharmaceutical Development, LLC
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Remeditex Ventures, LLC
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Merck Sharp & Dohme Corp.
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Vivo Capital Fund VIII, L.P.
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Vivo Capital Surplus Fund VIII, L.P.
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F-Prime Capital Partners Healthcare Fund IV LP
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venBio Global Strategic Fund II, L.P.
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Novo Holdings A/S (fka Novo A/S)
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Rock Springs Capital Master Fund LP
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Bay City Capital GF Xinde International Life Sciences USD Fund
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Aisling Capital IV, L.P.
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EXHIBIT 10.1
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
EXECUTION VERSION
EXCLUSIVE LICENSE AGREEMENT
by and between
MERCK SHARP & DOHME CORP.
and
TIGERCAT PHARMA, INC.
(and, for purposes of Sections 9.01 and11.02,
VELOCITY PHARMACEUTICAL HOLDINGS, LLC)
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
EXCLUSIVE LICENSE AGREEMENT
THIS EXCLUSIVE LICENSE AGREEMENT (this
“Agreement”
), dated as of December 21, 2012 (the
“Effective Date”
), is by and between MERCK SHARP & DOHME CORP., a corporation organized and existing under the laws of New Jersey (
“Merck”
), TIGERCAT PHARMA, INC., a corporation organized and existing under the laws of Delaware (
“Tigercat”
)
and, for purposes of Sections 9.01 and 11.02 only, VELOCITY PHARMACEUTICAL HOLDINGS, LLC, a corporation organized and existing under the laws of Delaware (
“VPH”
).
Merck and Tigercat are sometimes referred to herein individually as a
“
Party
”
and collectively as the
“
Parties
”
.
WHEREAS, Merck and its Affiliates (as defined herein) have discovered and developed the Licensed Compounds (as defined herein) and Merck is seeking a licensee to further develop and commercialize the Licensed Compounds; and WHEREAS, VPH has established Tigercat and intends to capitalize Tigercat as described in the Equity Agreements (as defined herein); and WHEREAS, Tigercat desires to develop and commercialize the Licensed Compounds with investment from VPH, as described herein, and with the development assistance of Velocity Pharmaceutical Development, LLC (
“VPD”
), as described herein; and WHEREAS, Merck and Tigercat desire to enter into a license arrangement whereby Tigercat will develop and commercialize Licensed Compound;
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, Merck, Tigercat and, as applicable, VPH hereby agree as follows:
ARTICLE I - DEFINITIONS
As used in this Agreement, the following capitalized terms, whether used in the singular or plural, shall have the respective meanings set forth below:
1.01
“Affiliate”
shall mean any individual or entity directly or indirectly controlling, controlled by or under common control with a Party to this Agreement. For purposes of this Agreement, the direct or indirect ownership of fifty percent (50%) or more of the outstanding voting securities of an entity, or the right to receive fifty percent (50%) or more of the profits or earnings of an entity shall be deemed to constitute control. Such other relationship as in fact results in actual control over the management, business and affairs of an entity shall also be deemed to constitute control.
1.02
“Calendar Quarter”
shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31, for so long as this Agreement is in effect.
1.03
“Calendar Year”
shall mean each successive period of twelve (12) months commencing on January 1 and ending on December 31, for so long as this Agreement is in effect.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
1.04
“Commercialization”
or
“Commercialize”
shall mean, with respect to Licensed Product, any and all activities directed to the marketing, promotion, distribution, offering for sale and selling of such product, importing and exporting such product for sale, and interacting with Regulatory Authorities regarding the foregoing.
1.05
“Compound Patent Rights”
shall mean those patents and patent applications that as of the Effective Date are owned or controlled by Merck (and/or any of its Affiliates) and are listed on
Schedule
1.24, that (A) have claims specifically covering the Licensed Compound or the Manufacture and/or use thereof; (B) are substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, certificates of invention, confirmations, re-examinations, extensions, supplementary protection certificates or the like, or the provisional applications of any such patents and patent applications; or (C) are foreign equivalents of any of the above.
1.06
“Development”
or
“Develop”
shall mean all preclinical research and development activities and all clinical drug development activities, including, among other things: drug discovery, toxicology, formulation, statistical analysis and report writing, conducting clinical trials for the purpose of obtaining, supporting and maintaining Marketing Authorizations (including without limitation, post-marketing studies), and regulatory affairs related to all of the foregoing, including without limitation the filing of INDs and NDAs and all activities in support of such filings.
1.07
“Diligent Efforts”
shall mean [***].
1.08
“Equity Agreements”
shall mean (i) that certain Investors’ Rights Agreement by and among Tigercat, Merck and VPH and Velocity Pharmaceutical Development, LLC (
“VPD”
), (ii) that certain Series A Preferred Stock Purchase Agreement by and between Tigercat and VPH, (iii) that certain Voting Agreement by and among Tigercat, Merck, VPH, VPD and certain other stockholders, and (iv) that certain Common Stock Purchase Agreement by and between Tigercat and Merck.
1.09
“FDCA”
shall mean the United States Federal Food Drug and Cosmetic Act and any successor acts thereto.
1.10
“Field”
shall mean the use of any Licensed Compound or Licensed Product to treat, prevent, or diagnose any disease, disorder or condition in humans, excluding, however, the treatment or prevention of nausea or emesis (including without limitation chemotherapy-induced nausea and vomiting and postoperative nausea and vomiting).
1.11
“Good Clinical Practices”
shall mean the then current Good Clinical Practices as such term is defined from time to time by the United States Food and Drug Administration (
“FDA”
)
or other relevant Regulatory Authority having jurisdiction over the Development, Manufacture or Commercialization of a Licensed Product in the Territory pursuant to its regulations, guidelines or otherwise.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
1.12
“Good Laboratory Practices”
shall mean the then current good laboratory practice regulations of the FDA as described in the United States Code of Federal Regulations (
“CFR”
) or any comparable corresponding foreign regulations or their respective successor regulations.
1.13
“Good Manufacturing Practices”
shall mean the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant Regulatory Authority having jurisdiction over the Development, Manufacture or Commercialization of a Licensed Product in the Territory pursuant to its regulations, guidelines or otherwise.
1.14
“IND”
shall mean any investigational new drug application with respect to the Licensed Compounds filed with the FDA for commencing clinical trials in humans, or any comparable application filed with the Regulatory Authorities in a country other than the USA prior to commencing clinical trials in humans in that country, as well as all supplements or amendments filed with respect to such filings.
1.15
“Indication”
shall mean a separate and distinct disease or medical condition in humans which a Licensed Product that is in clinical trials is intended to treat, prevent and/or diagnose and/or for which a Licensed Product has received Marketing Authorization.
1.16
“Initiation”
shall mean, with respect to a clinical trial, the administration of the first dose to a patient in such clinical trial.
1.17
“Know-How”
shall mean proprietary information and materials (whether patentable or not) relating to any Licensed Compound, any Licensed Product, a formulation, product improvement and/or Indication, or the Development or Manufacture or use of any of the foregoing, that are not in the public domain, including, without limitation, (a) ideas, discoveries, inventions, improvements, technology or trade secrets, (b) pharmaceutical, chemical and biological materials, products, components or compositions, (c) methods, procedures, formulas, processes, tests, assays, techniques, regulatory requirements and strategies, (d) biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, clinical, safety, Manufacturing and quality control data and information related thereto, (e) technical and non-technical data and other information related to the foregoing, (f) drawings, plans, designs, diagrams, sketches, specifications or other documents containing or relating to such information or materials and (g) all applications, registrations, licenses, authorizations, approvals and material correspondence relating to any Licensed Compound and/or any Licensed Product submitted to Regulatory Authorities.
1.18
“Licensed Compound”
shall mean [***].
1.19
“Licensed Product”
shall mean any pharmaceutical composition, dosage form or preparation that contains as an active ingredient, a Licensed Compound or any metabolite, prodrug, acid form, base form, ester, salt, stereoisomer, racemate, tautomer or polymorph of a Licensed Compound.
1.20
“Major European Country”
shall mean any of [***].
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
1.21
“Manufacture”
shall mean all activities related to the manufacturing of a pharmaceutical product, or any ingredient thereof, including but not limited to test method development and stability testing, formulation, process development, manufacturing for use in non-clinical or clinical studies, manufacturing scale-up, manufacturing quality assurance/quality control development, quality control testing (including in-process release and stability testing), packaging, release of product or any component or ingredient thereof, quality assurance activities related to manufacturing and release of product, and regulatory activities related to all of the foregoing.
1.22
“Marketing Authorization”
shall mean all approvals from the relevant Regulatory Authority necessary to market and sell a Licensed Product in any country and including, where relevant, pricing approval.
1.23
“Merck”
shall have the meaning set forth in the preamble to this Agreement.
1.24
“Merck Know-How”
shall mean the Know-How owned or controlled by Merck and/or any of its Affiliates as of the Effective Date that was used by Merck or its Affiliates in the Development or Manufacture of any Licensed Compound and that is listed on
Schedule 1.24
or is otherwise provided to Tigercat by Merck under this Agreement.
1.25
“NDA”
shall mean a New Drug Application, Biologics License Application, Worldwide Marketing Application, Marketing Authorization Application, filing pursuant to Section 510(k) of the FDCA, or similar application or submission for Marketing Authorization filed with a Regulatory Authority to obtain marketing approval for a biological, pharmaceutical or diagnostic product in that country or in that group of countries.
1.26
“Party”
or
“Parties”
shall have the meaning given to such terms in the preamble to this Agreement.
1.27
“Phase II Clinical Trial”
shall mean a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(b) or equivalent applicable regulatory requirements.
1.28
“Phase III Clinical Trial”
shall mean a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(c) or equivalent applicable regulatory requirements.
1.29
“Proprietary Information”
shall mean, as applicable, Know-How, information relating to the Development, Manufacturing or Commercialization of a Licensed Product and all other scientific, clinical, regulatory, marketing, financial and commercial information or data, whether communicated in writing, verbally or electronically, that is provided by one Party to the other Party in connection with this Agreement.
1.30
“Regulatory Authority”
shall mean any applicable government regulatory authority involved in granting approvals for the manufacturing, marketing, reimbursement and/or pricing of a Licensed Product in the Territory.
1.31
“Territory”
shall mean the entire world.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
1.32
“Tigercat”
shall have the meaning set forth in the preamble of this Agreement.
1.33
“Tigercat Know-How”
shall mean any and all Know-How developed by Tigercat and/or any of Tigercat’s Affiliates or sublicensees after the Effective Date.
1.34
“Tigercat Patent Rights”
shall mean any and all patents and patent applications that after the Effective Date are owned or controlled by Tigercat and/or any of Tigercat’s Affiliates or sublicensees that: (A) have claims specifically covering (i) any Licensed Compound or the Manufacture and/or use thereof, or (ii) any Licensed Product or the Manufacture and/or use thereof; (B) are substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, certificates of invention, confirmations, re-examinations, extensions, supplementary protection certificates or the like, or the provisional applications, of any such patents and patent applications; or (C) are foreign equivalents of any of the above.
1.35
“Third Party”
shall mean an entity other than Merck, Tigercat and their respective Affiliates.
1.36
“VPD”
shall have the meaning set forth in the preamble of this Agreement.
1.37
“VPH”
shall have the meaning set forth in the preamble of this Agreement.
1.38
Additional Definitions
. Each of the following definitions is set forth in the Section of this Agreement indicated below.
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Definition
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Section
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AAA
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13.02(a)
|
AEs
|
4.02(a)
|
Agents
|
9.01(b)
|
Agreement
|
Preamble
|
CFR
|
1.12
|
Development Funding
|
3.04
|
Development Plan
|
3.03(a)
|
Development Report
|
3.05
|
Effective Date
|
Preamble
|
Evaluation Period
|
3.07(b)
|
FDA
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1.11
|
Force Majeure
|
14.08
|
Inventory
|
4.01(a)
|
Liability
|
11.01
|
LIBOR
|
7.04
|
Merck Indemnified Party
|
11.01
|
Option Notice
|
3.07(a)
|
Option Information Package
|
3.07(b)
|
Services Agreement
|
3.02
|
Sublicense Agreement
|
2.04
|
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
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Term
|
12.01
|
Term Sheet
|
3.07(c)
|
Tigercat Indemnified Party
|
11.02
|
Third Party Purchaser
|
3.07(c)
|
ARTICLE II - LICENSE
2.01
License Grant.
Subject to the terms and conditions of this Agreement and Merck’s retained rights, Merck hereby grants the following to Tigercat:
|
|
(a)
|
Patent License.
An exclusive (even as to Merck and its Affiliates, except as provided in this Section 2.01) license, with the right to grant sublicenses as provided herein, under the Compound Patent Rights to make, have made, use, sell, offer for sale, and import (and to otherwise Develop, Manufacture, have Manufactured, export and Commercialize) any Licensed Compound and/or any Licensed Product in the Field in the Territory.
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(b)
|
Know-How License.
An exclusive (even as to Merck and its Affiliates, except as provided in this Section 2.01) license, with the right to grant sublicenses as provided herein, to Merck Know-How to make, have made, use, sell, offer for sale, and import (and to otherwise Develop, Manufacture, have Manufactured, export and Commercialize) any Licensed Compound and/or any Licensed Product in the Field in the Territory.
|
For the avoidance of doubt, Merck and its Affiliates retain (i) non-exclusive rights under the Compound Patent Rights and to Merck Know-How (including, without limitation, any Licensed Compounds) for preclinical research purposes, including screening and counterscreening, and (ii) all rights for all purposes outside the Field.
2.02
No Non-Permitted Use.
Tigercat hereby covenants that it shall not, and shall cause its Affiliates and sublicensees (including without limitation VPD) not to, use or practice, directly or indirectly, any Merck Know-How or Compound Patent Rights for any purpose outside the Field.
2.03
No Other Licenses.
No Party grants to any other Party under this Agreement any rights or licenses in or to any intellectual property, whether by implication, estoppel, or otherwise, other than the license rights that are expressly granted under this Agreement.
2.04
Right to Sublicense and Sublicense Agreements.
The licenses granted in Section 2.01 may be sublicensed in whole or in part by Tigercat, to one or more Affiliates and/or Third Parties, for any country in the Territory, within any fields within the Field, and with respect to one or more Licensed Compounds and/or Licensed Products; provided that any sublicense agreement shall be consistent with the terms and conditions of this Agreement, and in particular, but without limitation, shall include provisions for the benefit of Merck corresponding to Sections 2.02, 3.07, 7.03 and 11.01. Tigercat shall (i) use reasonable efforts to procure the performance by any sublicensee of the terms of each such sublicense agreement, and (ii) ensure that any sublicensee will comply with the applicable terms and conditions of this Agreement. Tigercat hereby guarantees the performance of its Affiliates and sublicensees, and the grant of
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
any sublicense will not relieve Tigercat of its obligations under this Agreement, except to the extent they are satisfactorily performed by such Affiliate or sublicensee.
2.05
Section 365(n) of the Bankruptcy Code.
All rights and licenses granted under or pursuant to any section of this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code. Each Party shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code or equivalent legislation in any other jurisdiction. Upon the bankruptcy of any Party, the licensed Party shall further be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property, which, if not already in its possession, shall be promptly delivered to such other Party, unless the Party in bankruptcy elects to continue, and continues, to perform all of its obligations under this Agreement.
ARTICLE III - DEVELOPMENT AND COMMERCIALIZATION
3.01
Overview.
As of the Effective Date, Tigercat shall be solely responsible for the Development Commercialization and Manufacturing, including all costs thereof, of any Licensed Compound and any Licensed Product in the Field in the Territory. Tigercat shall perform all Development activities in accordance with the IND for any Licensed Compound and all applicable laws, rules and regulations.
3.02
Services Agreement.
As of the Effective Date, Tigercat and VPD shall have entered into a services agreement (the “
Services Agreement
”) pursuant to which VPD shall design and manage the Development of the Licensed Compounds and Licensed Products. All costs associated with the Services Agreement shall be borne by Tigercat.
3.03
Development Plans
.
|
|
(a)
|
Initial Development Plan.
No later than the Effective Date, Tigercat and Merck shall have agreed on the initial Development plan for the Licensed Compounds and Licensed Products in the Field in the Territory, which shall be incorporated as part of this Agreement as
Schedule 3.03(a)
(as amended in accordance with this Agreement, the
“Development Plan”
).
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(b)
|
Annual Development Plan.
No later than [***] days after the end of each Calendar Year, Tigercat shall submit to Merck an updated Development Plan for the then current Calendar Year. Such update shall take into account completion, commencement, changes in or cessation of Development activities in sufficient detail to reflect the continued diligence of Tigercat. Merck shall have the right to comment on such updated Development Plan, but Tigercat shall have sole decision-making rights with respect to such Development Plan.
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(c)
|
Performance.
Tigercat shall perform, and shall cause its Affiliates, sublicensees, and Third Party contractors to perform, the activities described in the Development Plan in compliance with all applicable Good Laboratory Practices, Good Clinical Practices
|
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
and/or Good Manufacturing Practices and in compliance with all other applicable laws, rules, and regulations.
3.04
Development Funding.
Tigercat will use [***] it receives under the Equity Agreements (the
“Development Funding”
)
to fund the Development of Licensed Compounds and Licensed Products in accordance with the Development Plan. For the avoidance of doubt, amounts paid by Tigercat to VPD under the Services Agreement to design and manage the Development of the Licensed Compounds and Licensed Products shall be deemed to have been used to fund the Development of Licensed Compounds and Products in accordance with the Development Plan.
3.05
Development Reports.
Tigercat shall provide Merck with reasonably detailed reports describing the progress of the Development of all Licensed Compounds and Licensed Products (hereinafter
“Development Reports”
).
Such Development Reports shall be furnished on a [***] basis, within [***] following the end of the respective [***]. Each Development Report shall include the following information for the Licensed Compounds and Licensed Products: a description of the Development work conducted during the applicable [***], in reasonable detail, including clinical studies, formulation work, manufacturing work, other testing work and regulatory activity; timelines for such work; and key decision gates and milestones for such work.
3.06
Advance Notice of NDA Filing.
Tigercat shall give Merck at least [***] prior written notice of its intent to file the first NDA in the Territory for any Licensed Product.
3.07
[***].
ARTICLE IV - REGULATORY; MATERIALS AND INFORMATION TRANSFER
4.01
Materials and Regulatory Filings Transfer.
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|
(a)
|
As soon as is reasonably practicable following the Effective Date, Merck shall transfer to Tigercat, in a mutually agreed manner, such amounts of the Licensed Compounds (the
“Inventory”
) in Merck’s inventory as are set forth on
Schedule 1.24
. The Inventory shall be used only in preclinical Development in the Field and shall not be used for clinical Development (except to the extent that the Inventory is certified to be compliant with Good Manufacturing Practices by or on behalf of Tigercat) or for commercial purposes.
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(b)
|
As soon as is reasonably practicable after the Effective Date (or such other date as may be mutually agreed by the Parties), Merck shall assign and transfer to Tigercat the existing INDs covering the Licensed Compounds identified on
Schedule 1.24
and take such other actions as may be necessary to effect such assignment and transfer. All further submissions to any Regulatory Authorities relating to such INDs (including any subsequent NDAs and Marketing Authorizations) shall be filed in the name of and owned by Tigercat or its Affiliates. Tigercat or its Affiliates shall hold all Marketing Authorizations for any Licensed Products in the Field throughout the Territory.
|
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
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(c)
|
As soon as is reasonably practicable after the Effective Date (or such other date as may be mutually agreed by the Parties), Merck shall (i) transfer to Tigercat the Merck Know-How identified on
Schedule 1.24
and (ii) reasonably cooperate with Tigercat to address and answer Tigercat’s questions in understanding and utilizing the Merck Know-How. It is the intent of the Parties that this period of project transition extend no longer than [***] after the Effective Date; provided, however, that if reasonable cooperation is required after such [***], Tigercat shall reimburse Merck for the reasonable costs and expenses of providing such cooperation.
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(d)
|
Tigercat shall be solely responsible for all regulatory actions, communications and filings with, and submissions to, the FDA and other Regulatory Authorities in the Field in the Territory with respect to any Licensed Compound or Licensed Product. Merck will cooperate with Tigercat for a period of up to [***] after the Effective Date to facilitate a smooth transition of regulatory responsibilities under this Agreement. Further, Merck will provide reasonable assistance to Tigercat in responding to any requests, regulatory actions, communications or any other obligations requested by the FDA or any other Regulatory Authorities to the extent related to the Development of the Licensed Compounds prior to the Effective Date.
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(e)
|
Tigercat shall be solely responsible for interfacing, corresponding and meeting with the FDA and other Regulatory Authorities in the Field throughout the Territory with respect to any Licensed Compound or Licensed Product. Tigercat shall provide Merck with quarterly reports which include copies of any material correspondence and any meeting minutes from any material meetings with FDA or other Regulatory Authorities in the USA, the Major European Countries and Japan relating to approval of any Licensed Product during the prior Calendar Quarter, and respond to all reasonable inquiries by Merck with respect thereto.
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(f)
|
In the event that any Regulatory Authority (a) threatens or initiates any action to remove a Licensed Product from the market in any country in the Field in the Territory or (b) requires Tigercat, its Affiliates, or its sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of any Licensed Product in the Field, Tigercat shall notify Merck of such event within [***] after Tigercat becomes aware of the action, threat, or requirement (as applicable). Tigercat shall, to the extent reasonably practicable, notify Merck prior to initiating a recall or withdrawal of any Licensed Product in the Field in the USA, Japan, or a Major European Country. The decision as to whether to recall or withdraw a Licensed Product in the Field in the Territory shall be made by Tigercat in its sole discretion. Tigercat shall be responsible, at its sole expense, for conducting any such recalls or taking such other necessary remedial action.
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4.02
Pharmacovigilance
.
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|
(a)
|
Following the transfer of any INDs related to any Licensed Products from Merck to Tigercat, Tigercat shall be solely responsible for the collection, review, assessment, tracking and filing of information related to adverse events
(“AEs”
)
associated with each
|
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
Licensed Product in the Field, in accordance with 21 CFR 312.32, 314.80 and comparable regulations, guidance, directives and the like governing AEs associated with each Licensed Product that are applicable outside of the USA.
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|
(b)
|
Tigercat shall assume responsibility for maintaining a global safety database for any Licensed Products consistent with industry practices.
|
ARTICLE V - DILIGENCE
5.01
Diligent Efforts.
Tigercat shall use Diligent Efforts to Develop [***]. For clarity, (i) all Development efforts relating to a Licensed Compound and/or a Licensed Product made by any Affiliate or sublicensee of the rights granted to Tigercat under this Agreement will be attributed to the Diligent Efforts of Tigercat under this Section 5.01, and (ii) in no event shall Tigercat be required to devote more than [***] to the Development of the Licensed Compound and/or Licensed Product.
ARTICLE VI - MANUFACTURING
6.01
Manufacturing Responsibility.
As between the Parties, Tigercat will be responsible for the Manufacturing of any Licensed Compound and Licensed Product for use by Tigercat, its Affiliates, and its sublicensees and any Third Parties in the Field in the Territory.
ARTICLE VII - PAYMENTS
7.01
Upfront Licensing Fee.
In partial consideration for the licenses granted to Tigercat under this Agreement, Tigercat shall pay to Merck a non-refundable, non-creditable, upfront payment of One Million US Dollars (US$1,000,000), which shall be due within [***] of the Effective Date.
7.02
Upfront Equity Payment.
In further consideration for the licenses granted to Tigercat under this Agreement, Tigercat shall issue to Merck fully paid equity equivalent to [***] of the common stock of Tigercat as of the Effective Date (the
“Equity”
). The Equity shall be issued to Merck within [***] after the Effective Date. The Equity shares issued to Merck pursuant to this Section 7.02 shall convey the rights and be subject to the terms and conditions set forth in the Equity Agreements.
7.03
Milestone Payments.
In further consideration for the licenses granted to Tigercat under this Agreement, Tigercat shall pay to Merck each of the following non-refundable milestone payments based on attainment of the Development and regulatory milestones indicated below:
[***].
Tigercat shall notify Merck in writing within [***] after the achievement of each such milestone event, and Tigercat shall pay Merck the indicated amount no later than [***] after such notification to Merck.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
For clarity, the Parties acknowledge the following:
[***].
7.04
Method of Payment; Late Payments.
All payments to be made by Tigercat to Merck under this Agreement shall be paid by bank wire transfer in immediately available funds to such bank account as is designated in writing by Merck from time to time. Any amount owed by Tigercat to Merck under this Agreement that is not paid within the applicable time period set forth herein shall accrue interest at the rate of [***].
ARTICLE VIII - PATENTS
8.01
Prosecution and Maintenance of Patents.
Tigercat agrees to prosecute and maintain the Compound Patent Rights in the Field in the Territory at its sole cost and expense [***].
8.02
Option of Merck to Prosecute and Maintain Patents.
Tigercat shall give notice to Merck of any desire to cease prosecution and/or maintenance of the Compound Patent Rights in the Field in the Territory and, in such case, shall permit Merck (or any Merck Affiliate), at Merck’s sole discretion, to continue such prosecution or maintenance at its own expense.
8.03
Enforcement.
In the event that either Merck or Tigercat becomes aware of any alleged or threatened commercially material infringement in a country in the Territory of any issued patent within the Compound Patent Rights, it will notify the other Party in writing to that effect. Tigercat shall have [***] from the date of said notice to obtain a discontinuance of any such infringement within the Field or bring trial, suit or action against the Third Party infringer for such infringement within the Field. Tigercat shall bear all the expenses of any such trial, suit or action. Merck shall have the right, prior to commencement of the trial, suit or action brought by Tigercat, to join any such trial, suit or action. No settlement, consent judgment or other voluntary final disposition of such trial, suit or action may be entered into without the consent of Merck, such consent not to be unreasonably withheld, conditioned or delayed. In the event that Merck has not joined such trial, suit or action, Merck will reasonably cooperate with Tigercat in any such trial, suit or action, including by joining (and /or ensuring any relevant Merck Affiliate joins) such trial, suit or action if requested by Tigercat, at Tigercat’s sole cost and expense. Any recovery or damages derived from such trial, suit or action shall be retained by Tigercat. Tigercat shall incur no liability to Merck (or its Affiliates) as a consequence of such litigation or any unfavorable decision resulting therefrom, including any decision holding any of the Compound Patent Rights invalid or unenforceable.
8.04
Infringement and Third Party Licenses.
In the event that Tigercat’s, its Affiliates’ or its sublicensees’ making, having made, importing, exporting, using, Manufacturing, having Manufactured, distributing, marketing, promoting, offering for sale or selling any Licensed Compound or Licensed Product infringes, will infringe or is alleged by a Third Party to infringe, a claim of a patent that specifically covers any Licensed Compound, Licensed Product or its Manufacture, the Party becoming aware of same shall promptly notify the other. Tigercat will be responsible for defending any such infringement claim. Merck and its Affiliates shall cooperate fully with Tigercat in its efforts to defend against such infringement claim and shall agree to be a
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
party in any suit, if requested. Further, Merck shall have a right, in Merck’s sole discretion, to join or otherwise participate in such legal action with legal counsel selected by Merck; provided, however that such participation shall not undermine Tigercat’s right to control such legal action and such participation will be at Merck’s sole cost and expense. Tigercat shall notify and keep Merck apprised in writing of such action and shall consider and take into account Merck’s reasonable interests and requests regarding such action. Any settlement of such infringement claim that would admit liability on the part of Merck or any of its Affiliates shall be subject to Merck’s prior written approval, such approval not to be unreasonably withheld, conditioned or delayed.
8.05
Abandonment.
Tigercat shall give notice to Merck of the grant, lapse, revocation, surrender, invalidation or abandonment of any Compound Patent Rights licensed by Merck or its Affiliates for which Tigercat is responsible for the prosecution and maintenance under this Agreement.
ARTICLE IX - CONFIDENTIALITY AND PUBLICATION
9.01
Confidentiality
.
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|
(a)
|
Nondisclosure Obligation.
Merck and Tigercat shall each use any Proprietary Information received by it hereunder from the other Party only in accordance with this Agreement and shall not disclose to any Third Party any such Proprietary Information without the prior written consent of the other Party. The foregoing obligations shall survive the expiration or termination of this Agreement for a period of [***]. These obligations shall not apply to Proprietary Information that:
|
|
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(i)
|
is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by the receiving Party’s written records;
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(ii)
|
is at the time of disclosure, or thereafter becomes, published or otherwise part of the public domain without breach of this Agreement by the receiving Party;
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(iii)
|
is subsequently disclosed to the receiving Party by a Third Party who has the right to make such disclosure, as documented by the receiving Party’s written records;
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(iv)
|
is independently developed by the receiving Party or its Affiliates without the aid, use or application of any of the disclosing Party’s Proprietary Information, and such independent development can be documented by the receiving Party’s written records;
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(v)
|
is disclosed to any institutional review board of any entity conducting clinical trials with any Licensed Product or to any governmental agency or Regulatory Authority in order to obtain patents or to gain approval to conduct clinical trials or to market any Licensed Product, provided that such disclosure may be made only to the extent reasonably necessary to obtain such patents or authorizations; or
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Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
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(vi)
|
is required to be disclosed by law, regulation, rule, act or order of any Regulatory Authority or governmental agency to be disclosed, provided that notice is promptly delivered to the Party that provided such Proprietary Information in order to provide an opportunity to seek a protective order or other similar order with respect to such Proprietary Information, and thereafter the receiving Party discloses to the requesting entity only the minimum information required to be disclosed in order to comply with the request, whether or not a protective order or other similar order is obtained by the other Party.
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(b)
|
Disclosure to Agents.
Notwithstanding the provisions of Section 9.01(a) and subject to the other terms of this Agreement, Tigercat shall have the right to disclose Proprietary Information to its sublicensees, agents, consultants, Affiliates or other Third Parties (collectively
“Agents”
)
in accordance with this Section 9.01(b). Such disclosure shall be limited (i) only to those Agents directly involved in the Development, Manufacturing or Commercialization of any Licensed Compound or Licensed Product (or for such Agents to determine their interest in performing such activities) in accordance with this Agreement, or (ii) to the Proprietary Information which is relevant for any Agent to determine whether to sublicense any or all of the rights licensed to Tigercat under this Agreement. Any such Agents must agree in writing to be bound by confidentiality and non-use obligations essentially the same as those contained in this Agreement.
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(c)
|
Disclosure to Strategic Partners.
Notwithstanding the provisions of Section 9.01(a) and subject to the other terms of this Agreement, Tigercat shall have the right to disclose Proprietary Information to any investor or potential investor in Tigercat and/or VPH, shareholder or prospective shareholder of Tigercat and/or VPH, licensee or potential licensee of Tigercat, or acquirer or potential acquirer of Tigercat (collectively
“Strategic Partners”
)
in accordance with this Section 9.01(c). Such disclosure shall be limited to Proprietary Information relevant to the diligence process of such Strategic Partners in connection with a financing (or proposed financing), equity investment (or proposed investment), license or collaboration deal (or proposed license or collaboration deal), merger, consolidation or similar transaction involving Tigercat or its Affiliates in accordance with this Agreement. Any such Strategic Partners must agree in writing to be bound by confidentiality and non-use obligations essentially the same as those contained in this Agreement.
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9.02
Return of Confidential Information.
Upon termination of this Agreement, the receiving Party will return all documents, and copies thereof, including those in the possession of the receiving Party’s Agents pursuant to Section 9.01(b), containing the disclosing Party’s Proprietary Information at any time upon the written request of the disclosing Party. However, the receiving Party may retain one (1) copy of such documents in a secure location solely for the purposes of (i) determining its obligations hereunder, (ii) complying with any applicable regulatory requirements, or (iii) defending against any product liability or intellectual property infringement claim.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
9.03
Breach of Confidentiality.
The Parties agree that the disclosure of the disclosing Party’s Proprietary Information in violation of this Agreement may cause the disclosing Party irreparable harm and that any breach or threatened breach of this Agreement by the receiving Party entitles the disclosing Party to seek injunctive relief, in addition to any other legal or equitable remedies available to it, in any court of competent jurisdiction. For clarity, such disputes shall not be subject to Article XII.
9.04
No Publicity.
A Party may not use the name of another Party in any publicity or advertising and may not issue a press release or otherwise publicize or disclose any information related to the existence of this Agreement or the terms or conditions hereof, except (i) on the advice of its counsel as required by law (e.g., any Securities and Exchange Commission filings and disclosures), provided that the Party who will be disclosing such information has consulted with the other Party to the extent feasible prior to such disclosure with respect to the substance of the disclosure; or (ii) as consented to in advance by the other Party in writing. Furthermore, Tigercat shall provide Merck with reasonable advance written notice of any press release or other public disclosure relating to any Licensed Compound or Licensed Product.
9.05
Terms of Agreement.
No Party nor its Affiliates shall disclose any terms or conditions of this Agreement to any Third Party without the prior consent of the other Parties, except as follows: A Party and its Affiliates may disclose the terms or conditions of this Agreement (but not any other Proprietary Information, which may be disclosed only as described elsewhere in this Article IX), (a) on a need-to-know basis to its legal and financial advisors to the extent such disclosure is reasonably necessary, provided that such advisors are subject to confidentiality with regard to such information under an agreement or ethical obligation; (b) to a Third Party in connection with (i) a financing (or proposed financing) or an equity investment (or proposed investment) in such Party or its Affiliates, including to its shareholders and prospective shareholders, (ii) a merger, consolidation or similar transaction by such Party or its Affiliates, (iii) the sale of all or substantially all of the assets of such Party or its Affiliates, (iv) a securitization, (v) to facilitate the sublicensing of any or all of the rights licensed to Tigercat under this Agreement, or (vi) to facilitate the assignment of any or all of Tigercat’s rights and obligations under this Agreement (in accordance with Section 14.01(a)), provided that such Third Party executes a non-use and non-disclosure agreement and observes the same obligations of confidentiality as such Party owes under this Agreement with respect to Proprietary Information of the other Party; (c) to the United States Securities and Exchange Commission or any other securities exchange or governmental entity, including as required to make an initial or subsequent public offering, or (d) as otherwise required by law or regulation, provided that in the case of (c) and (d) the disclosing Party shall (x) if practicable, provide the other Party with reasonable advance notice of and an opportunity to comment on any such required disclosure, (y) if requested by such other Party, seek, or cooperate with such Party’s efforts to obtain, confidential treatment or a protective order with respect to any such disclosure to the extent available, at such other Party’s expense, and (z) use good faith efforts to incorporate the comments of such other Party in any such disclosure or request for confidential treatment or protective order.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
ARTICLE X - REPRESENTATIONS AND WARRANTIES
10.01
Representations and Warranties of Each Party.
Tigercat hereby represents, warrants and covenants to Merck, and Merck hereby represents, warrants and covenants to Tigercat as follows:
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(a)
|
it is a corporation duly organized and validly existing under the laws of the state or other jurisdiction of its incorporation;
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(b)
|
the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate action;
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(c)
|
it has the power and authority to execute and deliver this Agreement, to grant any and all licenses hereunder and to perform its obligations hereunder;
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(d)
|
the execution, delivery and performance by such Party of this Agreement and its compliance with the terms and provisions hereof does not and will not conflict with or result in a breach of any of the terms and provisions of, or constitute a default under, (i) any loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) the provisions of its corporate charter or other operative documents or bylaws; or (iii) any order, writ, injunction or decree of any court or Regulatory Authority entered against it or by which any of its property is bound;
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(e)
|
except for the Marketing Authorizations required to market any Licensed Product in the Territory, the execution, delivery and performance of this Agreement by such Party does not require the consent, approval or authorization of, or notice, declaration, filing or registration with, any governmental or Regulatory Authority and the execution, delivery or performance of this Agreement will not violate any law, rule or regulation applicable to such Party;
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(f)
|
this Agreement has been duly authorized, executed and delivered and constitutes such Party’s legal, valid and binding obligation enforceable against it in accordance with its terms subject, as to enforcement, to bankruptcy, insolvency, reorganization and other laws of general applicability relating to or affecting creditors’ rights and to the availability of particular remedies under general equity principles; and
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(g)
|
it shall comply with all applicable material laws and regulations relating to its activities under this Agreement.
|
10.02
Tigercat’s Representations.
Tigercat hereby represents, warrants and covenants to Merck as follows:
|
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(a)
|
during the Term of this Agreement it will not use in any capacity, in connection with any services to be performed in connection with this Agreement, any individual who has been debarred pursuant to the FDCA; and
|
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
|
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(b)
|
it has the capacity and resources to Develop Licensed Product and to Manufacture Licensed Compound.
|
10.03
Merck’s Representations.
Merck hereby represents and warrants to Tigercat that, to the best of its knowledge, as of the Effective Date, the patents and patent applications listed on
Schedule 1.24
are the only patents and patent applications owned or controlled by Merck (and/or any of its Affiliates) that are necessary for the Development of any Licensed Compound as contemplated in the Development Plan.
10.04
No Inconsistent Agreements.
No Party has in effect, and after the Effective Date no Party shall enter into, any oral or written agreement or arrangement that would be inconsistent with its obligations under this Agreement.
10.05
Representation by Legal Counsel.
Each Party hereto represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting of this Agreement. In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption shall exist or be implied against the Party that drafted such terms and provisions.
10.06
Disclaimer.
EXCEPT AS EXPRESSLY SET FORTH IN THIS ARTICLE X, THE LICENSED COMPOUNDS, LICENSED PRODUCTS, COMPOUND PATENT RIGHTS AND MERCK KNOW-HOW ARE PROVIDED “AS IS” AND WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY.
10.07
No Warranty.
EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, NO PARTY HERETO MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED. IN PARTICULAR, BUT WITHOUT LIMITATION, MERCK MAKES NO REPRESENTATION AND EXTENDS NO WARRANTY CONCERNING WHETHER ANY LICENSED COMPOUND OR LICENSED PRODUCT IS FIT FOR ANY PARTICULAR PURPOSE OR SAFE FOR HUMAN CONSUMPTION.
ARTICLE XI - INDEMNIFICATION AND LIMITATION ON LIABILITY
11.01
Indemnification by Tigercat.
Tigercat shall indemnify, defend and hold harmless Merck and its Affiliates, and each of its and their respective employees, officers, directors and agents (each of the foregoing, an
“Merck Indemnified Party”
) from and against any and all liability, loss, damage, cost, and expense (including reasonable attorneys’ fees) (collectively, a
“Liability”
)
that a Merck Indemnified Party may incur, suffer or be required to pay as a result of any Third Party claim, suit or action resulting from or arising in connection with [***]. Notwithstanding the foregoing, Tigercat shall have no obligation under this Agreement to indemnify, defend or hold harmless any Merck Indemnified Party with respect to any Liabilities
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
that result from the gross negligence or willful misconduct of any Merck Indemnified Party or that result from Merck’s breach of its obligations under this Agreement.
11.02
Indemnification by Merck.
Merck shall indemnify, defend and hold harmless Tigercat, VPD, VPH and their Affiliates, and each of their respective employees, officers, directors and agents (each of the foregoing, a
“Tigercat Indemnified Party”
)
from and against any Liability that a Tigercat Indemnified Party may incur, suffer or be required to pay as a result of any Third Party claim suit or action resulting from or arising in connection with [***]. Notwithstanding the foregoing, Merck shall have no obligation under this Agreement to indemnify, defend or hold harmless any Tigercat Indemnified Party with respect to any Liabilities that result from the gross negligence or willful misconduct of any Tigercat Indemnified Party or that result from Tigercat’s breach of its obligations under this Agreement.
11.03
Conditions to Indemnification.
The obligations of the indemnifying Party under Sections 11.01 and 11.02 are conditioned upon the delivery of written notice to the indemnifying Party of any potential Liability promptly after the indemnified Party becomes aware of such potential Liability. The indemnifying Party shall have the right to assume the defense of any suit or claim related to the Liability if it has assumed responsibility for the suit or claim in writing. If the indemnifying Party defends the suit or claim, the indemnified Party may participate in (but not control) the defense thereof at its sole cost and expense. Notwithstanding the foregoing, the Parties acknowledge and agree that failure of the indemnified Party to promptly notify the indemnifying Party of a potential Liability shall not constitute a waiver of, or result in the loss of, such Party’s right to indemnification under Section 11.01 or 11.02, as appropriate, except to the extent that the indemnifying Party’s rights, and/or its ability to defend against such Liability, are materially prejudiced by such failure to notify.
11.04
Settlements.
No Party may settle a claim or action related to a Liability without the consent of another Party, such consent not to be unreasonably withheld, if such settlement would impose any monetary obligation on such other Party or require such other Party to submit to an injunction or otherwise limit such other Party’s rights under this Agreement. Any payment made by a Party to settle any such claim or action shall be at its own cost and expense.
11.05
Limitation of Liability.
EXCEPT WITH RESPECT TO LIABILITY ARISING FROM BREACH OF ARTICLE IX, FROM ANY WILLFUL OR INTENTIONALLY WRONGFUL ACT BY EITHER PARTY OR TO THE EXTENT SUCH PARTY MAY BE REQUIRED TO INDEMNIFY THE OTHER PARTY UNDER THIS ARTICLE 11, NEITHER PARTY NOR ITS RESPECTIVE AFFILIATES AND SUBLICENSEES SHALL BE LIABLE FOR ANY LOST PROFITS, LOSS OF BUSINESS, LOSS OF CONTRACTS, DIMINISHED GOODWILL, DIMINISHED REPUTATION, OR SPECIAL, EXEMPLARY, CONSEQUENTIAL OR PUNITIVE DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHERWISE.
11.06
Insurance.
At such time as Tigercat or any of its sublicensees begins to Commercialize a Licensed Product, Tigercat shall, at its own expense, procure and maintain policies of comprehensive general liability insurance (including without limitation product liability
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
insurance) in the amount of [***]. Any such policies shall name Merck as an additional insured, and insurers will waive all rights of subrogation against Merck. Upon Merck’s request, Tigercat will promptly provide for itself and its sublicensees copies of certificates of insurance evidencing such coverages. Tigercat shall notify Merck not less than [***] in advance of any material change or cancellation of any policy. Tigercat shall continue to maintain such insurance in effect after the expiration or termination of this Agreement during any period in which Tigercat or its sublicensee continues to Manufacture or Commercialize any Licensed Product. If any insurance is on a claims made basis, Tigercat will maintain such insurance for a period of not less than [***] after it has ceased all Commercialization of any Licensed Product. In the event that it would be commercially reasonable for Tigercat to self-insure for liabilities of [***] (as a result of Tigercat’s acquisition or otherwise), then, notwithstanding the foregoing insurance obligations imposed by this Section 11.06, Tigercat may self-insure for any such liabilities.
ARTICLE XII - TERM AND TERMINATION
12.01
Term and Expiration.
This Agreement shall be effective as of the Effective Date and, unless terminated earlier by mutual written agreement of the Parties or pursuant to Section 12.02 or 12.03, this Agreement shall continue in effect until all of the milestones set forth in Section 7.03 have been achieved (the
“Term”
). Upon expiration of this Agreement, Tigercat’s licenses pursuant to Section 2.01 shall become fully paid-up, perpetual licenses.
12.02
Termination by Tigercat
.
|
|
(a)
|
Tigercat’s Right to Terminate.
Tigercat shall have the unilateral right to terminate this Agreement in its entirety without cause by giving thirty (30) days’ advance written notice to Merck. In the event of such termination, the rights and obligations hereunder shall terminate; provided, however, that any payment obligations due and owing as of the termination date shall continue.
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(b)
|
Effect of Termination.
Notwithstanding anything contained herein to the contrary, following any termination of this Agreement in its entirety under Section 12.02(a), all rights and licenses granted to Tigercat hereunder shall revert back to Merck pursuant to Section 12.05.
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12.03
Termination for Cause
.
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|
(a)
|
Termination for Cause.
This Agreement may be terminated, in its entirety, by written notice by either Party at any time during the Term of this Agreement:
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(i)
|
upon or after the breach of any material provision of this Agreement, if the breaching Party has not cured such breach within [***] following receipt of written notice from the non-breaching Party requesting cure of the breach or, if such breach is not susceptible of cure within such [***] period, the breaching Party has not taken appropriate steps to commence such cure during such [***] period and continued to diligently pursue such cure in a manner reasonably ensuring such cure within a reasonable period of time thereafter (not to exceed [***]). Any right to terminate
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Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
under this Section 12.03(a) shall be stayed and the cure period tolled in the event that, during any cure period, the Party alleged to have been in material breach shall have initiated dispute resolution in accordance with Article XIV with respect to the alleged breach, which stay and tolling shall last so long as the allegedly breaching Party diligently and in good faith cooperates in the prompt resolution of such dispute resolution proceedings; or upon the filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings by or against the other Party, or
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(ii)
|
upon an assignment of a substantial portion of the assets for the benefit of creditors by the other Party, or in the event a receiver or custodian is appointed for such Party’s business, or if a substantial portion of such Party’s business is subject to attachment or similar process; provided, however, that in the case of any involuntary bankruptcy proceeding, such right to terminate shall only become effective if the proceeding is not dismissed within [***] after the filing thereof.
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(b)
|
Effect of Termination for Cause on License
.
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(i)
|
Termination by Tigercat for Cause.
In the event this Agreement is properly terminated by Tigercat under Section 12.03(a), Tigercat’s licenses pursuant to Section 2.01 shall become perpetual licenses, provided that Tigercat continues to make the payments to be made to Merck by Tigercat pursuant to Article VII.
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(ii)
|
Termination by Merck for Cause.
In the event this Agreement is properly terminated by Merck under Section 12.03, the rights and licenses granted to Tigercat under Section 2.01 of this Agreement shall terminate and all rights to the Licensed Compound and the Licensed Products shall revert to Merck. In the event of termination under Section 12.03 as a result of a breach of Section 2.02, the Parties shall have the rights and obligations set forth in Section 12.05. In all other events of termination by Merck under Section 12.03, Tigercat shall, within [***] after the effective date of such termination, return or cause to be returned to Merck all Proprietary Information and Merck Know-How provided by Merck, as well as all Licensed Compounds and Licensed Products.
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12.04
Effect of Termination Generally.
Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination, and the provisions of Sections 2.03, 9.01, 9.02, 9.03, 10.05, 10.06, 10.07, 12.01, 12.02(b), 12.03(b), 12.04, and 12.05, and Articles XI, XIII, and XIV shall survive the expiration or termination of this Agreement. Any expiration or early termination of this Agreement shall be without prejudice to the rights of any Party against another accrued or accruing under this Agreement prior to termination, including the obligation to pay milestone payments for any milestones achieved prior to such termination.
12.05
Licensed Product Reversion.
Upon termination of this Agreement in its entirety by Merck as a result of a breach of Section 2.02 or by Tigercat pursuant to Section 12.02, at Merck’s option and upon Merck’s written request, the following provisions shall apply:
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(a)
|
Effective upon such termination, without further action by any Party, Merck shall have a worldwide, sublicensable, transferable, perpetual license from Tigercat, which shall be
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Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
exclusive in the Field, under any Tigercat Know-How and Tigercat Patent Rights existing at the time of termination that are necessary for and were actually used by Tigercat for the Development, Manufacture, or Commercialization of any Licensed Compound and/or Licensed Product. To the extent that the Development, Manufacture, or Commercialization of any Licensed Compound and/or Licensed Product by Merck or its sublicensee or assignee actually utilizes Tigercat Know-How or would, but for such license, infringe Tigercat Patent Rights, such license shall be royalty-bearing at the rate of [***] of the applicable Licensed Compound or Licensed Product. Merck’s license under this Section 12.05(a) shall be limited solely to the right to Develop, Manufacture and Commercialize any such Licensed Compound and/or Licensed Product in the Field in the Territory.
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(b)
|
Tigercat shall reasonably cooperate with Merck in order to enable Merck to assume responsibility for the Development, Manufacture and Commercialization of all Licensed Compounds and Licensed Products then being Developed, Manufactured or Commercialized by Tigercat. Such cooperation and assistance shall be provided in a timely manner, not to exceed six (6) months, and shall include the following, without limitation:
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(i)
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Tigercat shall transfer to Merck (or its nominee) all INDs, NDAs and Marketing Authorizations, and all supporting documentation for such filings and applications, made or obtained by Tigercat or its Affiliates or any of its sublicensees to the extent relating to any Licensed Compound and/or Licensed Product then being Commercialized or in Development.
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(ii)
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Tigercat shall assign to Merck all of its rights in any trademarks claiming any proprietary name approved by a Regulatory Authority for any Licensed Product or utilized by Tigercat for any Licensed Product (i.e., a Licensed Product’s “brand name”) and shall transfer to Merck all of its rights in any domain names containing such trademarks, in each case to the extent that such trademarks have actually been or are planned to be utilized by Tigercat in connection with the Commercialization of Licensed Product in the Field, but excluding any trademarks which apply to products other than just Licensed Products. Any assignment or transfer to Merck pursuant to this Section 12.05(b)(ii) shall be at no cost to Merck.
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(iii)
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Tigercat shall transfer to Merck (or its nominee), to the extent not previously provided, a copy of all Tigercat Know-How in its possession or under its control relating to any Licensed Compound and/or Licensed Product then being Commercialized or in clinical Development by Tigercat and reasonably necessary or useful for its continued Development, Manufacture and/or Commercialization, including without limitation all information contained in Tigercat’s regulatory and/or safety databases, all in the format then currently maintained by Tigercat.
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Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
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(iv)
|
Upon the request of Merck, Tigercat shall transfer to Merck, at a price to be agreed upon in good faith by the Parties, that shall not be more than [***] of Tigercat’s fully allocated Manufacturing cost for the Licensed Compound and/or Licensed Product, all quantities of Licensed Compound and Licensed Product in the possession of Tigercat or its Affiliates (including, without limitation, clinical trial supplies and Licensed Product intended for Commercialization).
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The Parties shall use Diligent Efforts to complete the transition of the Development, Manufacture and Commercialization of all Licensed Compounds and Licensed Products from Tigercat to Merck pursuant to this Section 12.05 as soon as is reasonably possible.
ARTICLE XIII - DISPUTE RESOLUTION
13.01
Informal Discussions.
Except as otherwise provided herein, in the event of any controversy or claim arising out of or relating to this Agreement, or the rights or obligations of the Parties hereunder, or the relationship between the Parties with respect to Licensed Compound or Licensed Product, the Parties shall first try to settle their differences amicably between themselves. Any Party may initiate such informal dispute resolution by sending written notice of the dispute to the other Parties, and within thirty (30) days after such notice appropriate representatives of the Parties shall meet for attempted resolution by good faith negotiations. If such representatives are unable to resolve such disputed matter within thirty (30) days, any Party may refer the matter by written notice to the others to the Worldwide Head of Licensing, Merck Research Laboratories, or his designee, and the Chief Executive Officer of Tigercat, or his designee, for discussion and resolution. If such individuals or their designees are unable to resolve such dispute within thirty (30) days of such written notice or if the recipient Party does not respond within thirty (30) days of such written notice, any Party may initiate arbitration proceedings in accordance with the provisions of this Article XIII.
13.02
Arbitration.
All disputes arising out of or relating to this Agreement, or the rights or obligations of the Parties hereunder, or relating in any way to the relationship between the Parties with respect to any Licensed Compound or Licensed Product, shall be finally and exclusively settled by arbitration by a panel of three (3) arbitrators, provided such dispute is not an “Excluded Claim”. As used in this Section, the phrase
“Excluded Claim”
shall mean a dispute, controversy or claim that concerns (a) the validity or infringement of a patent, trademark or copyright; or (b) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory.
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(a)
|
The arbitration proceeding shall be conducted under the Commercial Arbitration Rules of the American Arbitration Association (
“AAA”
)
with such proceedings to be held in New York, New York. In all cases, the arbitration proceedings shall be conducted in English, and all documents that are submitted in the proceeding shall be in English. Judgment upon the award rendered by arbitration may be issued and enforced by any court having competent jurisdiction.
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Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
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(b)
|
If a Party intends to begin an arbitration to resolve a dispute, such Party shall provide written notice to the other Parties, informing the other Parties of such intention and any statement of claim required under the applicable arbitration rules (as determined in accordance with Section 13.02(a)). Within twenty (20) business days after its receipt of such notice, the other Parties shall, by written notice to the Party initiating arbitration, add any additional issues to be resolved that would be considered mandatory counterclaims under New York law. For clarity, the resolution of any disputes regarding such counterclaims shall be conducted in the same proceedings as the initial claims.
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(c)
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Within forty-five (45) days following the receipt of the notice of arbitration, the Party referring the matter to arbitration shall appoint an arbitrator and promptly notify the other Parties of such appointment. If (i) the initiating Party is Tigercat, then Merck shall, upon receiving such notice, appoint a second arbitrator within twenty-one (21) days, or (ii) alternatively, the initiating Party is Merck, then Tigercat shall, upon receiving such notice, appoint a second arbitrator within twenty-one (21) days, and (iii) in either case, the two (2) arbitrators shall, within fifteen (15) days of the appointment of the second arbitrator, agree on the appointment of a third arbitrator who will act with them and be the chairperson of the arbitration panel. In the event that either Party shall fail to appoint an arbitrator within thirty (30) days after the commencement of the arbitration proceeding, the arbitrator shall be appointed by the AAA. In the event of the failure of the two (2) arbitrators to agree within sixty (60) days after the commencement of the arbitration proceeding to appoint the chairperson, the chairperson shall also be appointed by the AAA.
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(i)
|
All of the arbitrators shall have significant legal or business experience in pharmaceutical licensing matters. The arbitrators shall not be employees, directors or shareholders of any Party or any of their Affiliates.
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(ii)
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Each Party shall have the right to be represented by counsel throughout the arbitration proceedings.
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(iii)
|
To the extent possible, the arbitration hearings and award will be maintained in confidence.
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(iv)
|
In any arbitration pursuant to this Agreement, the award or decision shall be rendered by a majority of the members of the panel provided for herein, with each member having one (1) vote. The arbitrators shall render a written decision regarding their resolution of the dispute that shall set forth in reasonable detail the facts of the dispute and the reasons for their decision. The decision of the arbitrators shall be final and non-appealable and binding on the Parties.
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13.03
Injunctive Relief.
By agreeing to arbitration, the Parties do not intend to deprive any competent court of such court’s jurisdiction to issue a pre-arbitral injunction, pre-arbitral attachment or other order in aid of the arbitration proceedings and the enforcement of any award or judgment. Without prejudice to such provisional remedies in aid of arbitration as may be
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
available under the jurisdiction of a national court, the court of arbitration shall have full authority to grant provisional remedies and to award damages for failure of any Party to respect the court of arbitration’s order to that effect.
13.04
Expenses of Arbitration and Expert Determination.
Each Party shall bear its own attorneys’ fees, costs, and disbursements arising out of the arbitration, and Merck, on the one hand, and Tigercat, on the other hand, shall pay an equal share of the fees and costs of the arbitrators; provided, however, that the arbitrators shall be authorized to determine whether a Party is the prevailing Party, and if so, to award to that prevailing Party reimbursement for its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges and travel expenses). Absent the filing of an application to correct or vacate the arbitration award as permitted by applicable law, each Party shall fully perform and satisfy the arbitration award within [***] of the service of the award.
ARTICLE XIV - MISCELLANEOUS
14.01
Assignment.
Neither party shall assign this Agreement without the prior written consent of the other Party; provided, however, either Party may assign this Agreement without the prior written consent of the other Party in connection with the sale of such Party (including, without limitation, through the sale of all or substantially all of such Party’s assets, through the sale of a controlling interest in the outstanding shares of such Party, or through any merger, reorganization, consolidation or combination of such Party). This Agreement shall be binding upon, and inure to the benefit of, each Party, its Affiliates, and its permitted successors and assigns. Each Party shall be responsible for the compliance by its Affiliates with the terms and conditions of this Agreement.
14.02
Governing Law.
This Agreement shall be governed, interpreted and construed in accordance with the laws of the State of New York, without giving effect to its conflict of law principles. Subject to the terms of this Agreement, all disputes under this Agreement shall be governed by binding arbitration pursuant to the mechanism set forth in Article XIII herein.
14.03
Waiver.
The waiver by any Party hereto of any right hereunder, or of any failure of another Party to perform, or of any breach by another Party, shall not be deemed a waiver of any other right hereunder or of any other breach by or failure of such other Party, whether of a similar nature or otherwise.
14.04
Independent Relationship.
Nothing herein contained shall be deemed to create an employment, agency, joint venture or partnership relationship between the Parties hereto or any of their agents or employees, or any other legal arrangement that would impose liability upon one Party for the act or failure to act of the other Party. No Party shall have any power to enter into any contracts or commitments or to incur any liabilities in the name of, or on behalf of, the other Party, or to bind the other Party in any respect whatsoever.
14.05
Export Control.
This Agreement is made subject to any restrictions concerning the export of products or technical information from the USA that may be imposed upon or related to Merck or Tigercat from time to time by the United States government. Furthermore, Tigercat
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
agrees that it will not export, directly or indirectly, any technical information acquired from Merck under this Agreement or any products using such technical information to any country for which the United States government or any agency thereof at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the Department of Commerce or other agency of the United States government when required by an applicable statute or regulation.
14.06
Entire Agreement; Amendment.
This Agreement, including the Exhibits and Schedules hereto, the Services Agreement and the Equity Agreements set forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto and supersede and terminate all prior agreements and understandings between the Parties with regard to the subject matter of this Agreement. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth herein and therein. No subsequent alteration, amendment, change, waiver or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.
14.07
Notices.
Any notice required or permitted to be given or sent under this Agreement shall be hand delivered or sent by express delivery service or certified or registered mail, postage prepaid, or by facsimile transmission (with written confirmation copy by express delivery service or certified or registered mail) to the Parties at the addresses and facsimile numbers indicated below.
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if to Tigercat, to:
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Tigercat Pharma, Inc,
[***]
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if to Merck, to:
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Merck Sharp & Dohme Corp.
[***]
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With a copy to:
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Merck Sharp & Dohme Corp.
[***]
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Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
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and for patent-related notices, a copy to:
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Merck Sharp & Dohme Corp.
[***]
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Any such notice shall be deemed to have been received on the earlier of the date actually received or the date [***] after the same was posted or sent. A Party may change its address or its facsimile number by giving the other Parties written notice, delivered in accordance with this Section 14.07.
14.08
Force Majeure.
Failure of any Party to perform its obligations under this Agreement (except the obligation to make payments when properly due) shall not subject such Party to any liability or place it in breach of any term or condition of this Agreement if such failure is due to any cause beyond the reasonable control of such non-performing Party (
“Force Majeure”
), unless conclusive evidence to the contrary is provided. Causes of non-performance constituting Force Majeure shall include, without limitation, acts of God, fire, explosion, flood, drought, war, riot, sabotage, embargo, strikes or other labor trouble, failure in whole or in part of suppliers to deliver on schedule materials, equipment or machinery, interruption of or delay in transportation, a national health emergency or compliance with any order or regulation of any government entity acting with color of right. The Party affected shall promptly notify the other Parties of the condition constituting Force Majeure and shall exert reasonable efforts to eliminate, cure and overcome any such causes and to resume performance of its obligations with all possible speed; provided that nothing herein shall obligate a Party to settle on terms unsatisfactory to such Party any strike, lockout or other labor difficulty, any investigation or other proceeding by any public authority or any litigation by any Third Party. If a condition constituting Force Majeure as defined herein exists for more than ninety (90) consecutive days, the Parties shall meet to negotiate a mutually satisfactory resolution to the problem, if practicable. If the Parties cannot in good faith reach a satisfactory resolution to the problem within sixty (60) days of meeting, the matter shall be handled pursuant to the dispute resolution provisions of Article XIII herein.
14.09
Severability.
If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties shall in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.
14.10
Counterparts.
This Agreement may be signed in any number of counterparts (including by facsimile or electronic transmission), each of which shall be deemed an original, but all of which shall constitute one and the same instrument. After facsimile or electronic transmission, the Parties agree to execute and exchange documents with original signatures.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
14.11
Captions.
The captions of this Agreement are solely for the convenience of reference and shall not affect its interpretation.
14.12
Further Actions.
Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
IN WITNESS WHEREOF, this Agreement has been executed by the duly authorized representatives of the Parties.
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MERCK SHARP & DOHME CORP.
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TIGERCAT PHARMA, INC.
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By:
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/s/ Roger Pomerantz, M.D., F.A.C.P.
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By:
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/s/ James W. Larrick, M.D., Ph.D.
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Name:
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Roger Pomerantz, M.D., F.A.C.P.
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Name:
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James W. Larrick, M.D., Ph.D.
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Title:
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World Wide Head of Licensing & Acquisitions and Knowledge Management
Global Franchise Head for Infectious Diseases and Senior Vice President
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Title:
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President
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For Purposes of Sections 9.01 and 11.12 only,
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VELOCITY PHARMACEUTICAL HOLDINGS, LLC
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By:
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/s/ David Collier
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Title:
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Manager
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Exhibit 10.2
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
LICENSE AND COLLABORATION AGREEMENT
BY AND BETWEEN
MENLO THERAPEUTICS INC.
AND
TORII PHARMACEUTICAL CO., LTD,
AND
JAPAN TOBACCO INC.
E
FFECTIVE
D
ATE
: August 10, 2016
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
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Page
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ARTICLE 1
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DEFINITIONS
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ARTICLE 2
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LICENSES
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2.1
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License to Licensee
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2.2
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Sublicense Rights
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2.3
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Third Party Licenses
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2.4
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MTI Retained Rights
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2.5
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Grant-Back License
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2.6
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[***]
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2.7
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[***]
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2.8
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Right to Expand the Field
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2.9
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Formulation Development
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ARTICLE 3
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GOVERNANCE
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3.1
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Alliance Managers
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3.2
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Joint Steering Committee
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ARTICLE 4
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DEVELOPMENT AND DILIGENCE
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4.1
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Development Plan
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4.2
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Development Responsibility
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4.3
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Subcontractors and Sublicensees
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4.4
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Clinical Development Milestone Obligation
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4.5
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[***]
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4.6
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MTI Pediatric Formulations.
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ARTICLE 5
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REGULATORY MATTERS AND DATA
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5.1
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Regulatory Activities
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5.2
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Regulatory Reports
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5.3
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Regulatory Costs
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5.4
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Notification of Threatened Action
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5.5
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Adverse Event Reporting and Safety Data Exchange
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5.6
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Remedial Actions
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5.7
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Data Exchange and License
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5.8
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Established Inspection Records
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Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
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ARTICLE 6
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COMMERCIALIZATION
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6.1
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Commercialization Responsibilities
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6.2
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Commercialization Plan
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6.3
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Commercial Diligence
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6.4
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[***]
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6.5
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Non-Compete
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ARTICLE 7
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MANUFACTURE AND SUPPLY
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7.1
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Supply Agreements
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7.2
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Licensee Formulations
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7.3
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Selection of a Contract Manufacturer
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7.4
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Accreditation
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7.5
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Audits of Manufacturing Facilities by Regulatory Authority
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7.6
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Audits of Manufacturing Facilities by Licensee
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ARTICLE 8
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COMPENSATION
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8.1
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Initial Payments
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8.2
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Development Milestone Payments.
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8.3
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Commercial Milestone Payments. Licensee shall make each of the
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8.4
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Royalties
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8.5
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Third Party Royalty Offsets
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8.6
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Foreign Exchange
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8.7
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Payment Method; Late Payments
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8.8
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Records
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8.9
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Audits
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8.10
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Taxes
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ARTICLE 9
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INTELLECTUAL PROPERTY MATTERS
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9.1
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Ownership
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9.2
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Third Party Licenses
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9.3
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Prosecution of Patents
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9.4
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Enforcement of MTI Patents or MTI Owned Improvement Patents
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9.5
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Enforcement of Other Improvement Patents
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Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
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9.6
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Patents Licensed From Third Parties
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9.7
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Infringement of Third Party Rights in the Territory
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9.8
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Patent Extension
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9.9
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Trademarks
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ARTICLE 10
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REPRESENTATIONS AND WARRANTIES; COVENANTS
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10.1
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Mutual Representations and Warranties
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10.2
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Additional Representations and Warranties of MTI
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10.3
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Mutual Covenants
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10.4
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Merck License Agreement
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10.5
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Disclaimer
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ARTICLE 11
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INDEMNIFICATION
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11.1
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Indemnification by MTI
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11.2
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Indemnification by Licensee
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11.3
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Indemnification Procedures
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11.4
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Limitation of Liability
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ARTICLE 12
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CONFIDENTIALITY
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12.1
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|
Confidentiality
|
|
12.2
|
|
Authorized Disclosure
|
|
12.3
|
|
Destruction of Confidential Information
|
|
12.4
|
|
Publicity; Terms of the Agreement
|
|
12.5
|
|
Technical Publication
|
|
12.6
|
|
Equitable Relief
|
|
ARTICLE 13
|
TERM AND TERMINATION
|
|
13.1
|
|
Term
|
|
13.2
|
|
Termination by MTI for Patent Challenge
|
|
13.3
|
|
Termination for Breach
|
|
13.4
|
|
Termination for Bankruptcy
|
|
13.5
|
|
Termination by Licensee
|
|
13.6
|
|
Effect of Termination
|
|
13.7
|
|
Obligations until Termination
|
|
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
|
|
|
|
|
13.8
|
|
Survival
|
|
ARTICLE 14
|
DISPUTE RESOLUTION
|
|
14.1
|
|
Disputes
|
|
14.2
|
|
Internal Resolution
|
|
14.3
|
|
Arbitration
|
|
14.4
|
|
Patent and Trademark Disputes
|
|
ARTICLE 15
|
MISCELLANEOUS
|
|
15.1
|
|
MTI’s Change of Control
|
|
15.2
|
|
Entire Agreement; Amendment
|
|
15.3
|
|
Force Majeure
|
|
15.4
|
|
Notices
|
|
15.5
|
|
No Strict Construction; Headings
|
|
15.6
|
|
Assignment
|
|
15.7
|
|
Performance by Affiliates
|
|
15.8
|
|
Further Actions
|
|
15.9
|
|
Severability
|
|
15.1
|
|
No Waiver
|
|
15.11
|
|
Independent Contractors
|
|
15.12
|
|
Governing Law
|
|
15.13
|
|
Counterparts
|
|
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
Execution Version
CONFIDENTIAL
LICENSE AND COLLABORATION AGREEMENT
This
L
ICENSE AND
C
OLLABORATION
A
GREEMENT
(the “
Agreement
”) is entered into as of August 10, 2016 (the “
Effective Date
”) by and between
MENLO THERAPEUTICS
INC.,
a corporation organized and existing under the laws of Delaware having a principal place of business at 4085 Campbell Avenue, Suite 200, Menlo Park, CA 94025 (“
MTI
”), and
TORII PHARMACEUTICAL CO., LTD.
, a Japanese corporation having a principal place of business at Torii Nihonbashi Building, 4-1, Nihonbashi-Honcho 3-chome, Chuo-ku, Tokyo, 103-8439, Japan (“
Torii
”) and
JAPAN TOBACCO INC.
, a Japanese corporation having a principal place of business at JT Bldg. 2-1, Toranomon 2-chome, Minato-ku, Tokyo 105- 8422, Japan (“
JT
”). Torii and JT may be jointly referred to as “
Licensee
”. Licensee and MTI may each be referred to as a “
Party
” or collectively be referred to as the “
Parties
”.
RECITALS
W
HEREAS
,
MTI has, pursuant to that certain Exclusive License Agreement between MTI and Merck Sharp & Dohme Corp (“
Merck
”) dated as of December 21, 2012 (the “
Merck License Agreement
”) licensed certain rights from Merck to Serlopitant in the Field (as defined below);
W
HEREAS
,
simultaneously with the execution of this Agreement, MTI, Licensee and Merck have entered a letter agreement in the form attached as
Exhibit A
(the “
Letter Agreement
”), providing Licensee with additional licensing protections in the event the Merck License Agreement terminates;
W
HEREAS
,
MTI desires to license to Licensee rights that MTI owns or controls (including rights in licensed by MTI under the Merck License Agreement) to technology related to Serlopitant in Japan, and Licensee desires to accept such license, for the commercialization of products containing Serlopitant in Japan; and
W
HEREAS
, MTI and Licensee desire to establish a collaboration for the development and commercialization of products containing Serlopitant in Japan, including the product candidate referred to by MTI as VPD-737, for the treatment of diseases and conditions other than nausea or emesis, in accordance with the terms and conditions set forth herein;
N
OW
, T
HEREFORE
, in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Agreement, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
The terms in this Agreement with initial letters capitalized, whether used in the singular or the plural, shall have the meaning set forth below or, if not listed below, the meaning designated elsewhere in this Agreement (and derivative forms of them shall be interpreted
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
accordingly). The terms “include,” “includes,” “including” and derivative forms of them shall be deemed followed by the phrase “without limitation” regardless of whether such phrase appears there (and with no implication being drawn from its inconsistent inclusion or non-inclusion).
1.1
“
AAA
” has the meaning set forth in Section 14.3.
1.2
“
Acquiror
” has the meaning set forth in Section 15.6.
1.3
“Adjusted Daily Yakka Price” means the [***].
1.4
“
Affiliate
” means, with respect to a Person, any Person that controls, is controlled by or is under common control with such first Person. For purposes of this definition only, “control” means (a) to possess, directly or indirectly, the power to direct the management or policies of a Person, whether through ownership of voting securities, by contract relating to voting rights or corporate governance or otherwise, or (b) to own, directly or indirectly, fifty percent (50%) or more of the outstanding securities or other ownership interest of such Person.
1.5
“
Alliance Manager
” has the meaning set forth in Section 3.1.
1.6
“
Back-up Manufacturing Rights
” means Licensee’s right to [***]
1.7
“
Bankrupt Party
” has the meaning set forth in Section 13.4.
1.8
“
Bankruptcy Code
” has the meaning set forth in Section 13.4.
1.9
[***]
1.10
“
Change of Control
” means with respect to a Party, the occurrence of either of the following transactions (or series of related transactions) involving such Party:
(a)
merger, consolidation, stock sale or sale or transfer of all or substantially all of the Party’s assets or business pertaining to this Agreement, or other similar transaction or series of transactions, with another Person, except following such transaction (or series of transactions) where: (i) the Persons who were the beneficial owners of the outstanding voting securities (if any) of such Party immediately prior to such transaction beneficially own, directly or indirectly, at least fifty percent (50%) of the combined voting power of the then outstanding voting securities entitled to vote generally in the election of directors or similar governing persons of the corporation or other entity (the “Successor”) resulting from such transaction(s), or (ii) at least fifty percent (50%) of the members of the Board of Directors or similar governing body of the Successor were members of the Board of Directors of such Party at the time of the execution of the initial agreement(s) providing for such transaction(s); or
(b)
any transaction or series of related transactions in which any Person or group of related Persons acquires beneficial ownership of securities of the Party representing more than fifty percent (50%) of the combined voting power of the then outstanding securities of such Party.
1.11
“
Claims
” has the meaning set forth in Section 11.1.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
1.12
“
Clinical Development
” or “
Clinically Develop
” means all Development activities which are directed to the preparation for, conduct of, and analysis of a clinical trial or study of the Product, including, without limitation, as applicable, preclinical testing, toxicology, the examination of particular patient sub-populations within a given indication, and regulatory affairs which do not relate specifically to manufacturing of the Product (including preparation and submission of Regulatory Materials but excluding the Chemistry Manufacturing and Controls related portions of an such Regulatory Materials).
1.13
“
Combination Product
” means [***].
1.14
“
Commercialization Plan
” has the meaning set forth in Section 6.2.
1.15
“
Commercialize
” means to market, promote, sell, offer for sale and/or distribute.
1.16
“
Commercially Reasonable Efforts
” means, with respect to a Party’s obligations under this Agreement, the carrying out of such obligations with a level of effort and resources [***].
1.17
“
Competing Company
” means a Person which, or an Affiliate of which, has [***].
1.18
“Competing Product”
means a prescription product containing [***].
1.19
“
Compound
” means (a) any and all forms of Serlopitant (including, as appropriate, salts, esters and other relevant derivative structures) and (b) any other compound claimed in the MTI Patents.
1.20
“
Confidential Information
” of a Party means any and all information disclosed by such Party to the other Party under this Agreement or under the Prior CDA, whether in oral, written, graphic or electronic form.
1.21
“
Control
” means, with respect to any particular Data, Know-How or Patent, that a Party (a) owns or (b) has a license (other than a license granted to such Party under this Agreement) to such Data, Know-How or Patent and, in each case, has the ability to grant to the other Party access, a license, or a sublicense (as applicable) to the Data, Know-How or Patent on the terms and conditions set forth in this Agreement without violating the terms of any then-existing agreement or other arrangement with any Third Party, paying such Third Party additional consideration, knowingly infringing the Patent rights of a Third Party, or misappropriating the proprietary or trade secret information of a Third Party.
1.22
“
Cooperative Other Licensee
” has the meaning set forth in Section 2.5(b).
1.23
[***]
1.24
“
Cover
” means, with respect to a Compound or Product and a particular Patent, that the use, manufacture, sale, offer for sale, or importation of the Compound or Product would, absent a license, infringe a Valid Claim of such Patent.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
1.25
“
Data
” means all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical and analytical, safety, quality control, manufacturing, preclinical, clinical data, nonclinical data, chemistry, manufacturing and controls data, and data from post-Commercialization trials or results which relates to the Products and/or the Compounds. For clarity, Data includes Safety Data and Regulatory Data.
1.26
[***]
1.27
[***]
1.28
“
Develop
” means activities that relate to obtaining, maintaining or expanding Regulatory Approval of a Product, including nonclinical testing, toxicology testing, clinical trials, and preparation and submission of applications for obtaining, maintaining or expanding Regulatory Approval of a Product; provided, however, that Development shall exclude Commercialization and the building of commercial inventory of a Product.
1.29
“
Developing Party
” has the meaning set forth in Section 2.9.
1.30
“
Development Milestone
” has the meaning set forth in Section 4.4.
1.31
“
Development Plan
” means the plan set forth on
Exhibit C
setting forth the activities to be conducted to Clinically Develop the Compound.
1.32
“
Dollar
” or “
$
” means a USA dollar.
1.33
“
EMA
” means the European Medicines Agency or any successor entity.
1.34
“
Event of Bankruptcy
” has the meaning set forth in Section 13.4.
1.35
“
Excluded Study
” means each of the following clinical studies originally conducted by Merck:
(a)
[***];
(b)
[***];
(c)
[***]; and
(d)
[***].
1.36
[***]
1.37
“
Executive Officer
” means, with respect to MTI, [***], and with respect to Licensee, [***].
1.38
[***]
1.39
“
FD&C Act
” means the USA Federal Food, Drug and Cosmetic Act, as amended.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
1.40
“
FDA
” means the USA Food and Drug Administration or any successor entity.
1.41
“
Field
” means the treatment, prevention, or diagnosis of any disease, disorder or condition in humans, excluding, however, the treatment or prevention of nausea or emesis (including without limitation chemotherapy-induced nausea and vomiting and postoperative nausea and vomiting). Notwithstanding the foregoing, the Parties may expand the definition of Field pursuant to the provisions of Section 2.8.
1.42
“
First Commercial Sale
” means, with respect to a Product, the first sale, transfer or disposition for value or for end use to a Third Party of such Product in the Territory after Regulatory Approval has been obtained in the Territory.
1.43
“
Formulation Technology
” has the meaning set forth in Section 2.9.
1.44
“
Governmental Authority
” means any multinational, federal, state, local, municipal, provincial or other governmental authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).
1.45
[***]
1.46
“IND”
means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, or (b) the equivalent application to the equivalent agency in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.
1.47
“
Indemnified Party
” has the meaning set forth in Section 11.3.
1.48
“
Indemnifying Party
” has the meaning set forth in Section 11.3.
1.49
“
Infringement
” has the meaning set forth in Section 9.4(b).
1.50
“
Improvement Patents
” means any Patents claiming inventions relating to the Compound or any Product (including, without limitation, use, formulation and, to the extent solely applicable to Product, manufacturing), patent applications of which are filed after the Effective Date.
1.51
“
Joint Steering Committee
” or “
JSC
” means the committee formed by the Parties as described in Section 3.2.
1.52
“
Jointly Owned Improvement Patents
” means any Improvement Patents which claims inventions conceived and reduced to practice jointly by (i) employees and/or agents of Licensee and/or any of its Affiliates and (ii) employees and/or agents of MTI and/or any of its Affiliates.
1.53
“
Know-How
” means all technical information and know-how, including inventions, discoveries, trade secrets, specifications, instructions, processes, formulae, expertise, materials,
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
methods, protocols and other technology applicable to formulations, compositions or products or to their manufacture, development, registration, use or marketing or processes for their manufacture, formulations containing them or compositions incorporating or comprising them, and including all data, instructions, processes, formula, and expertise.
1.54
“
Laws
” means all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision, domestic or foreign.
1.55
“
Letter Agreement
” has the meaning set forth in the Recitals.
1.56
“
Liabilities
” has the meaning set forth in Section 11.1.
1.57
“
Licensee Data
” means all Data generated by or on behalf of Licensee or its Affiliates during the Term.
1.58
“
Licensee Formulations
” means the forms and formulations of Products developed by Licensee or its Affiliates, Sublicensees and contractors for which it pursues Clinical Development or Commercialization.
1.59
“
Licensee Grant-Back License
” has the meaning set forth in Section 2.5(b).
1.60
“
Licensee Indemnitees
” has the meaning set forth in Section 11.1.
1.61
“
Licensee Owned Improvement Know-How
” means all Know-How owned by Licensee or its Affiliates which is developed during the Term and that is necessary for or actually used by Licensee, the Development of Products in the Field. For clarity, Licensee Owned Improvement Know-How excludes (a) Know-How contained within the Licensee Owned Improvement Patents and (b) all Data.
1.62
“
Licensee Owned Improvement Patents
” means any Improvement Patents Controlled by Licensee or its Affiliates which claim an invention conceived and reduced to practice during the Term by employees and/or agents of Licensee and/or any of its Affiliates and which are not Jointly Owned Improvement Patents.
1.63
“
Licensee Partners
” has the meaning set forth in Section 12.4(d).
1.64
“
Manufacturing Development
” means all Development activities which are directed to the manufacturing of the Product and Compound, [***].
1.65
“Merck License Agreement”
has the meaning set forth in the recitals, a copy of which is attached hereto as
Exhibit F,
and any amendments thereto.
1.66
“
MTI Data
” means all Data Controlled by MTI or its Affiliate as of the Effective Date or generated by or on behalf of MTI or its Affiliates during the Term.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
1.67
“
MTI Formulations
” means (i) the oral tablet forms of the Product existing as of the Effective Date, (ii) any later forms and formulations of Products in the dosage range which are being clinically developed or commercialized by MTI or its Affiliates, (iii) any oral tablet forms of Products between [***]; and (iv) MTI Pediatric Formulations.
1.68
“
MTI Indemnitees
” has the meaning set forth in Section 11.2.
1.69
“
MTI Know-How
” means all Know-How Controlled by MTI or its Affiliate [***].
1.70
“
MTI Owned Improvement Patents
” means any Improvement Patents which claim inventions conceived and reduced to practice by employees and/or agents of MTI and/or any of its Affiliates and which are not Jointly Owned Improvement Patents.
1.71
“
MTI Partners
” has the meaning set forth in Section 12.4(d).
1.72
“
MTI Patents
” means the Patents listed in
Exhibit B
and any reissues, substitutions, confirmations, renewals, extensions, registrations, validations, re-examinations, additions, continuations, continued prosecution applications, continuations-in-part, divisionals, or any Supplementary Protection Certificates or restoration of patent terms thereof or thereto as well as any equivalents thereof in any country.
1.73
“
MTI Pediatric Formulations
” means the oral suspension forms or formulation of the Product as may be developed by MTI or its Affiliates during the Term specifically for pediatric use and for which MTI or its Affiliates receives Regulatory Approval outside of the Territory.
1.74
“
MTI Technology
” means the MTI Know-How, the MTI Patents and the MTI Owned Improvement Patents.
1.75
“
NDA
” means a New Drug Application, as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, and the equivalent application to the equivalent agency in any other regulatory jurisdiction in the Territory.
1.76
[***]
1.77
“
Net Sales
” means, [***].
1.78
[***]
1.79
“
Non-Bankrupt Party
” has the meaning set forth in Section 13.4.
1.80
[***]
1.81
“
Other Licensee
” means any Third Party licensee of MTI that MTI has granted rights under the MTI Technology outside the Territory with respect to the Compound and/or Products.
1.82
“
Other-Licensee Data
” means all Data Controlled by an Other Licensee.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
1.83
[***]
1.84
“
Other Licensee Owned Improvement Know-How
” means all Know-How Controlled by an Other Licensee which is developed during the term of the Other Licensee’s agreement with MTI that is necessary for or actually used by such Other Licensee in, the Development of Products in the Field. For clarity, Other Licensee Owned Improvement Know-How excludes (a) Know-How contained within the Other Licensee Owned Improvement Patents and (b) all Other Licensee Data.
1.85
“
Other Licensee Owned Improvement Patents
” means all Improvement Patents Controlled by an Other Licensee which are developed during the term of the Other Licensee’s agreement with MTI that Cover the Development or Commercialization of Products in the Field.
1.86
[***]
1.87
[***]
1.88
“
Patents
” means, collectively, (a) pending patent applications (and patents issuing therefrom), issued patents, utility models and designs; and (b) reissues, substitutions, confirmations, renewals, extensions, registrations, validations, re-examinations, additions, continuations, continued prosecution applications, continuations-in-part, divisionals, or any Supplementary Protection Certificates or restoration of patent terms of or to any such patents, patent applications, utility models or designs, in each case being enforceable within the applicable territory.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
1.89
“
Person
” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.
1.90
“
Past Clinical Study Report
” means an IND Enabling Past Clinical Study Report or a NDA Enabling Past Clinical Study Report.
(a)
“
IND Enabling Past Clinical Study Report
” means each of the [***] clinical study reports summarizing in a form acceptable to the Regulatory Authority in the Territory the pre-existing clinical data arising from each of the following clinical studies originally conducted by Merck:
[***]; and
[***].
(b)
“
NDA Enabling Past Clinical Study Report
” means each of the [***] clinical study reports summarizing in a form acceptable to the Regulatory Authority in the Territory the pre-existing clinical data arising from each of the following clinical studies originally conducted by Merck:
[***]; and
[***].
1.91
“
Pharmacovigilance Agreement
” has the meaning given to such term in Section 5.5.
1.92
“
Phase I Clinical Trial
” means a human clinical trial conducted in any country that would satisfy the requirements of 21 CFR 312.21(a) (or its successor regulation, or the equivalent in any foreign country) and is intended to determine the metabolism and pharmacological actions of the drug in humans, the side effects associated with increased doses, and, if possible, to gain early evidence on effectiveness.
1.93
“Phase II Clinical Trial
” means a human clinical trial conducted in any country that would satisfy the requirements of 21 CFR 312.21(b) (or its successor regulation, or the equivalent in any foreign country) and is intended to explore one or more doses, dose response, and duration of effect, and to generate initial evidence of clinical activity and safety, for a Product in the target patient population.
1.94
“Phase III Clinical Trial
” means a clinical trial in an extended human patient population designed to obtain data determining efficacy and safety of a Product to support Regulatory Approvals in the proposed therapeutic indication, as more fully defined in 21 C.F.R. §312.21(c), or its successor regulation, or the equivalent in any foreign country.
1.95
[***]
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
1.96
“
Premium Level
” means an [***].
1.97
“
Pricing Approval
” means such approval, agreement, determination or decision by a Governmental Authority establishing prices in the Territory for a Product that can be charged to consumers and/or will be reimbursed by health insurance society(ies).
1.98
“
Prior CDA
” means that certain [***].
1.99
“
Product
” means any pharmaceutical product containing the Compound, either alone or in combination with one or more therapeutically active ingredients, in all dosage forms and formulations. For clarity “Product” includes a Combination Product.
1.100
“
Product Marks
” has the meaning set forth in Section 9.9.
1.101
“
Regulatory Approval
” means all approvals necessary for the commercial sale of a Product in the Field in a given country or regulatory jurisdiction, which may include satisfaction of all applicable regulatory and notification requirements, but which shall exclude any pricing and reimbursement approvals.
1.102
“
Regulatory Authority
” means, in a particular country or jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval in such country or jurisdiction.
1.103
“
Regulatory Data
” means any Data relating to the Development of the Product in a given jurisdiction that is required by any Regulatory Authority in a different jurisdiction to be (i) included or referenced in an IND and/or NDA in such different jurisdiction or (ii) otherwise submitted to such Regulatory Authority.
1.104
“
Regulatory Materials
” means regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals, any pricing and reimbursement approvals, and/or other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Develop, manufacture, market, sell or otherwise Commercialize a Product in a particular country or jurisdiction.
1.105
“
Remedial Action
” has the meaning given to such term in Section 5.6.
1.106
“
Required Third Party Agreement
” has the meaning set forth in Section 8.5.
1.107
“
Revenue
” has the meaning set forth in Section 9.4(f).
1.108
“
Royalty Term
” means on a [***].
1.109
“
Safety Data
” means any and all data arising in Development, Commercialization or other use, testing or application of a Product which is related to the safety profile of such Product.
1.110
“
Sublicense Agreement
” has the meaning set forth in Section 2.2(a).
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
1.111
“Sublicensee
” means any Third Party sublicensee (including such sublicensee’s Affiliates and further sublicensees) of Licensee that Licensee has granted rights under the MTI Technology with respect to the Compound and/or Products in accordance with Section 2.2.
1.112
“
Sublicensee Data
” means all Data Controlled by a Sublicensee.
1.113
[***]
1.114
“Sublicensee Owned Improvement Know-How
” means all Know-How Controlled by a Sublicensee which is developed during the term of the Sublicense Agreement that is necessary for or actually used by such Sublicensee in the Development of Products in the Field. For clarity, Sublicensee Owned Improvement Know-How excludes (a) Know-How contained within the Sublicensee Owned Improvement Patents and (b) all Sublicensee Data.
1.115
“
Sublicensee Owned Improvement Patents
” means all Improvement Patents Controlled by a Sublicensee which are developed during the term of the Sublicense Agreement that Cover the Development or Commercialization of Products in the Field.
1.116
[***]
1.117
[***]
1.118
“
Supply Agreements
” has the meaning set forth in Section 7.1.
1.119
“
Tax Documents
” has the meaning set forth in Section 8.1(a).
1.120
“
Term
” has the meaning set forth in Section 13.1.
1.121
“
Territory
” means Japan.
1.122
“
Third Party
” means any Person not including the Parties or the Parties’ respective Affiliates.
1.123
“
USA
” means the United States of America, including all possessions and territories thereof.
1.124
“
Valid Claim
” means a claim of a Patent, which claim is pending and has not been finally abandoned or finally rejected or is issued and unexpired and has not been found to be unpatentable, invalid or unenforceable by a court or other authority having jurisdiction, from which decision no appeal is taken, shall be taken or can be taken.
ARTICLE 2
LICENSES
2.1
License to Licensee
.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
Subject to the terms and conditions of this Agreement, MTI hereby grants to Licensee during the Term an exclusive, royalty-bearing license, with the right to sublicense solely as provided in Section 2.2, under the MTI Technology:
(i)
to make, have made, use, import, export Products in order to Develop Products in the Field and in the Territory, and
(ii)
to make, have made, use, import, export, offer for sale, sell and have sold Products in order to Commercialize Products in the Field and in the Territory.
For clarity, (1) the right to make and have made Products granted under Section 2.1(i) and (ii) only applies to the Licensee Formulations or in connection with the Back-up Manufacturing Rights; Licensee is not granted any right to make or have made the Compound or to make or have made any Product other than (A) Licensee Formulations or (B) in connection with the Back-up Manufacturing Rights; (2) the rights granted under Section 2.1(i) and (ii) include the right to make and have made Licensee Formulations and exercise the Back-up Manufacturing Rights anywhere in the world solely for Development and/or Commercialization in the Territory; (3) notwithstanding the foregoing, Licensee and its Affiliates shall have the right to conduct any non-clinical testing or packaging of the Products within or outside the Territory, whether or not Back-up Manufacturing Rights have been exercised; (4) MTI retains the right to make and have made the Compound and/or Products in the Territory for Development or Commercialization outside the Territory (or to supply Licensee with Product in accordance with the Supply Agreements), (5) the right to Develop Products granted under Section 2.1(a)(i) includes the non-exclusive right to conduct Development (excluding clinical trials or other human use of the Product) anywhere in the world and (6) the rights granted under Sections 2.1(a)(i) and (ii) are exclusive with respect to MTI’s rights in the MTI Technology. Licensee shall not, and shall cause its Affiliates or Sublicensees not to, use or practice any MTI Technology outside the scope of the license granted to it under this Section 2.1.
2.2
Sublicense Rights
.
(a)
Licensee shall have the right to grant sublicenses of the licenses granted in Sections 2.1, 5.7(a), 5.7(b), 5.7(c), 5.7(f) and 9.1(c) (and, to the extent permitted by the underlying licenses with Other Licensees, Section 2.6) to its Affiliates or Sublicensees solely as set forth in this Section 2.2 (each such sublicense, a “
Sublicense Agreement
”). Licensee shall remain primarily responsible for all of its Affiliates and Sublicensees’ activities and any and all failures by its Affiliates and Sublicensees to comply with the applicable terms of this Agreement and Licensee shall at all times remain liable for the performance and actions of its Affiliates and Sublicensees. Licensee shall be entitled to retain all consideration it receives in relation to granting any such Sublicense Agreement, provided Licensee shall be responsible for making all payments to MTI contemplated under Article 8 regardless of whether the activity of Licensee, its Affiliate or any of their respective Sublicensees or agents gives rise to such payment obligation.
(b)
Licensee shall, within [***] after entering into any Sublicense Agreement with a Third Party, notify MTI thereof and provide MTI with a true and complete copy of the Sublicense Agreement after redaction of financial terms and other relevant competitive information between Licensee and Sublicensee.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
(c)
Each Sublicense Agreement shall be consistent with the terms and conditions of this Agreement and shall include provisions binding and subjecting the Affiliate or Sublicensee to all applicable terms and conditions of this Agreement in the same manner and to the same extent as Licensee is bound thereby. Additionally, each Sublicense Agreement will include provisions requiring that such Sublicense automatically terminates in the event the Sublicensee (directly or indirectly, individually or in association with any other person or entity) challenges the validity, enforceability or scope of any MTI Patents or MTI Owned Improvement Patents anywhere in the world.
2.3
Third Party Licenses
. For the avoidance of doubt, MTI shall be responsible for payment obligations to Third Parties for Patents and Know-How within the MTI Technology that are licensed to MTI by a Third Party prior to the Effective Date, if any. Licensee hereby acknowledges and agrees that its sublicense under such in-licensed MTI Technology (if any) is subject to the terms and conditions of the applicable license agreement governing MTI’s license of such in-licensed MTI Technology, including, specifically, the Merck License Agreement.
2.4
MTI Retained Rights
. Notwithstanding the rights granted to Licensee in Section 2.1 and without limiting the generality of Section 2.1(a), MTI retains all rights under the MTI Technology to make and have made Products for any purpose outside the Territory and/or outside of the Field. Except as explicitly set forth in this Agreement, MTI shall not be deemed by estoppel or implication to have granted Licensee any other licenses or other rights to any intellectual property.
2.5
Grant-Back License
.
(a)
Licensee shall and hereby does grant to MTI a non-exclusive, sublicensable (in accordance with Section 2.5(b)), fully paid-up, royalty-free license under Licensee’s and its Affiliate’s rights in the Licensee Owned Improvement Patents and Licensee Owned Improvement Know-How:
(i)
to make, have made, use, import, export offer for sale, sell, and have sold Products in order to Develop Products in the Field and outside the Territory, and
(ii)
to make, have made, use, import, export, offer for sale, sell and have sold Products in order to Commercialize Products in the Field and outside the Territory.
For clarity, the rights granted under Section 2.5(a) include the right to make and have made the Compound and or Products in the Territory solely for Development and Commercialization outside the Territory (or with respect to supplying Licensee in accordance with the Supply Agreements).
(b)
MTI shall have the right to sublicense the rights granted to it in Sections 2.5(a), 5.7(a), 5.7(b), 5.7(d), 5.7(f) and 9.1(c) (and, to the extent permitted by each underlying license with a Sublicensee, Section 2.7) to its Affiliates and to any Other Licensee to the extent such Other Licensee has granted an Other Licensee Non-Exclusive Grant-Back License to Licensee (such Other Licensee, a “
Cooperative Other Licensee
”), provided that MTI shall at all times remain liable for the performance and actions of its Affiliates and Other Licensees. MTI shall not, and shall
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
not permit any of its Affiliates or Other Licensees to, use or practice any Licensee Owned Improvement Patents or Licensee Owned Improvement Know-How outside the scope of the license granted to it under this Section 2.5. The rights granted in this Section 2.5 are referred to as “
Licensee Grant-Back License
”.
(c)
Notwithstanding any provisions to the contrary, the licenses rights, and access to Patents, Know-How and Data (other than Regulatory Data or Safety Data) granted to MTI hereunder excludes any license right or access to the extent relating to a non-generic therapeutically-active ingredient used in a Combination Product regardless of whether such non-
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
generic therapeutically-active ingredient is Controlled by Licensee or otherwise. For clarity, this Section 2.5(c) is not intended to affect Licensee’s obligations or MTI’s rights under Section 5.7 with respect (i) to all Safety Data relating to any such Combination Product or otherwise and (ii) to any Regulatory Data relating to the Compound.
2.6
[***]
2.7
[***]
2.8
Right to Expand the Field
. In the event the Merck License Agreement is amended to include in the rights licensed by MTI the treatment or prevention of nausea or emesis (including without limitation chemotherapy-induced nausea and vomiting and postoperative nausea and vomiting) or any part thereof, MTI will offer Licensee the right to expand the definition of “Field” to include such uses; provided, however, in order to exercise Licensee’s right, if MTI made a payment to Merck in order to expand the field under the Merck License Agreement, Licensee will pay, as sole compensation therefor, to MTI an amount equal to (a) MTI’s payment obligations to Merck to effect the expansion of the Field in the Territory under the Merck License Agreement or, (b) in the event MTI’s new rights under the Merck License Agreement are broader in geographic scope than the Territory, a payment in relative proportion to the value of such rights in the Territory. Upon Licensee’s exercise of the rights granted hereunder and making of any required payment hereunder, the definition of “Field” will be deemed to include the treatment or prevention of nausea or emesis (including without limitation chemotherapy-induced nausea and vomiting and postoperative nausea and vomiting) or the relevant part thereof.
2.9
Formulation Development
. During the Term, each Party (the “
Developing Party
”) may, in its discretion and subject to the licenses granted in Section 2.1, engage a Third Party to develop additional formulations of a Product and such engagement may result in the development of Patents and/or Know-How relating formulations of a Product (“
Formulation Technology
”). To the extent any Formulation Technology is Controlled by the Developing Party, it will automatically be included in the licenses granted to the other Party under Sections 2.1 or 2.5, as applicable. To the extent any Formulation Technology is not Controlled by the Developing Party and is instead Controlled by a Third Party, upon the request of the other Party, the Developing Party will cooperate and in good faith facilitate negotiations between such Third Party and the other Party to allow the other Party to use and exploit such Formulation Technology in a manner consistent with the rights of such other Party under this Agreement. For clarity, neither Party will pay any additional consideration for rights to Formulation Technology Controlled by a Developing Party.
ARTICLE 3
GOVERNANCE
3.1
Alliance Managers.
Within [***] after the Effective Date, each Party shall appoint and notify the other Party of the identity of a representative having the [***] to act as its alliance manager under this Agreement (the “
Alliance Manager
”). The Alliance Managers shall
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
serve as the primary contact points between the Parties for the purpose of providing each Party with information on the progress of the Parties’ Development and Commercialization of Products. The Alliance Managers shall also be primarily responsible for facilitating the flow of information and otherwise promoting communication, coordination and collaboration between the Parties. Each Party may replace its Alliance Manager at any time upon written notice to the other Party.
3.2
Joint Steering Committee
.
(a)
Formation and Role
. Within [***] days after the Effective Date, the Parties shall establish a Joint Steering Committee (the “
Joint Steering Committee
” or “
JSC
”) to facilitate the exchange of information relating to each Party’s Development and Commercialization activities with respect to the Compound and/or Products. The JSC shall provide a forum for each Party to apprise the other and, to the extent applicable, coordinate, strategies and timelines for the Development, Regulatory Approval and Commercialization of Product in the Territory. Decisions of the JSC, as brought to a vote by the chairperson(s), shall be made [***]. The JSC shall not have the power to bind either of the Parties or to make any tactical or day-to-day operational decisions with respect to either Party’s activities under this Agreement or otherwise. The JSC may establish and may separately dissolve sub-committees (with equal representation from both Parties) for detailed or technical discussions.
(b)
Members
. Each Party shall initially appoint [***] representatives to the JSC, each of whom shall be a senior officer or employee of the applicable Party. The JSC may change its size from time to time by mutual consent of its members; however, at all times the JSC shall be comprised of equal number of members from each Party. Each Party may replace its representatives at any time upon written notice to the other Party specifying the prior representative(s) and their replacement(s). Either Party may designate substitutes for its representatives if one (1) or more of such Party’s designated representatives is unable to be present at a meeting. The JSC shall have a chairperson from each Party. The role of the chairpersons shall be to convene and preside at the meeting of the JSC, but the chairperson shall have no additional powers or rights beyond those held by other JSC representatives.
(c)
Meetings.
The JSC shall meet at least [***] time per every [***] period during the Term unless the Parties mutually agree in writing to a different frequency for such meetings. [***] may also call a special meeting of the JSC (by videoconference or teleconference) by at least [***] prior written notice to the other Party in the event such Party reasonably believes that a significant matter must be addressed prior to the next regularly scheduled meeting. No later than [***] prior to any meeting of the JSC (other than a special meeting), the chairperson of the JSC shall prepare and circulate an agenda for such meeting; provided, however, that [***] may propose additional topics to be included on such agenda, either prior to or in the course of such meeting. The JSC may meet in person, by videoconference or by teleconference, provided however, at least [***] shall be in person unless the Parties [***] in writing to waive such requirement in lieu of a videoconference or teleconference. In-person JSC meetings shall be held at locations alternately selected by MTI and by Licensee. Each Party shall bear the expense of its respective JSC members’ participation in JSC meetings. The chairperson of the JSC shall be responsible for preparing reasonably detailed written minutes of
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
all JSC meetings. MTI shall prepare and send draft meeting minutes to each member of the JSC for review and approval within [***] after each JSC meeting. Such minutes shall be deemed approved [***] of the JSC provides amendments or edits to such minutes within [***] of receipt. Each Party may bring one or more additional participants to any meeting (e.g., individuals with expertise in relevant technical or regulatory issues), provided (A) such additional participant is bound by confidentiality obligations at least as restrictive as those contemplated under this Agreement and (B) such additional participants will not have a vote in any matters before the JSC.
(d)
Change of Control
. In the event that (i) MTI or its Affiliate undergoes a Change of Control to a Competing Company or (ii) MTI or its Affiliate acquires control of a Competing Company (except in case that MTI’s Affiliate becomes a Third Party hereunder as the result of such Change of Control), the Confidential Information of Licensee disclosed to MTI during any JSC meeting or pursuant to the functions of the JSC shall not be disclosed directly or indirectly to such Competing Company’s personnel [***].
ARTICLE 4
DEVELOPMENT AND DILIGENCE
4.1
Development Plan
. Attached hereto as
Exhibit C
is the initial Development Plan, setting forth the activities to be conducted by Licensee to Develop a Product in the Territory and in the Field. [***]. If and when there is a material change to the Development activities to be conducted by Licensee, [***].
4.2
Development Responsibility
. Licensee shall have sole responsibility for all Development (both Clinical Development and Manufacturing Development) and shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for Products in the Field and in the Territory. Licensee shall be solely responsible for all costs associated with such Development activities.
4.3
Subcontractors and Sublicensees
.
(a)
Either Party may perform any of its Development obligations under this Agreement through its Affiliates and through one or more subcontractors, provided that (i) such Party remains responsible for the work allocated to such Affiliates, or subcontractors to the same extent it would if it had done such work itself; (ii) the Affiliate, or subcontractor (as the case may be) undertakes in writing obligations of confidentiality and non-use regarding Confidential Information of the other Party, that are substantially the same as those undertaken by the Parties pursuant to Article 12 hereof, and (iii) in the case of Licensee, the Affiliate, or subcontractor (as the case may be) agree in writing to assign all rights or grant sufficient rights in any Data, inventions, other Know-How and other intellectual property developed in the course of performing any such work to Licensee and in the case of MTI, the Affiliate, or subcontractor (as the case may be) agree in writing to assign all rights or grant sufficient rights in any Data, inventions, other Know-How and other intellectual property developed in the course of performing any such work to MTI.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
(b)
Either Party may perform any of its Development obligations under this Agreement through one or more sublicensees or licensees, as applicable, provided that (i) such Party remains responsible for the work allocated to such sublicensees or licensees to the same extent it would if it had done such work itself; and (ii) the sublicensee or licensee undertakes in writing obligations of confidentiality and non-use regarding Confidential Information of the other Party, that are substantially the same as those undertaken by the Parties pursuant to Article 12 hereof.
4.4
Clinical Development Milestone Obligation
.
(a)
Licensee shall [***].
(b)
[***]
4.5
[***]
4.6
MTI Pediatric Formulations.
During the Term, [***].
ARTICLE 5
REGULATORY MATTERS AND DATA
5.1
Regulatory Activities
.
(a)
Except as detailed in Section 5.1(b), Licensee shall be responsible for conducting all Development activities related to Regulatory Materials and Regulatory Approvals in the Field and in the Territory. Licensee shall be responsible for preparing and submitting the NDAs in the Territory and in the Field for all indications for the Product. Licensee shall file and own all right, title and interest in all regulatory filings designed to obtain or support Regulatory Approval in the Territory.
(b)
Upon Licensee’s reasonable request, MTI shall assist Licensee in conducting all (or certain) Manufacturing Development activities related to Regulatory Materials and Regulatory Approvals in the Field and in the Territory, [***]. Licensee shall be responsible for preparing and submitting those portions of the NDAs relating to Manufacturing Development (including the Chemistry Manufacturing and Controls sections) in the Territory and in the Field for all indications for the Product.
(c)
Upon Licensee’s reasonable request, MTI shall assist Licensee in responding in a timely manner all queries and requests received by Licensee from the Regulatory Authority in the Territory.
5.2
Regulatory Reports
. Each Party shall keep the other Party informed of material regulatory developments relating to Products in the Territory through regular reports at the JSC meetings. Licensee shall promptly notify MTI of any material Regulatory Materials (other than routine correspondence) received from any Regulatory Authority in the Territory and shall provide MTI with copies thereof within [***] after receipt and shall consider in good faith any input from MTI in preparing responses. Licensee shall provide MTI with reasonable advance notice of all
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
material meetings, conferences, and discussions scheduled with any Regulatory Authority in the Territory concerning a Product.
5.3
Regulatory Costs
.
(a)
Licensee shall be solely responsible for all costs and expenses incurred by Licensee in the preparation, filing and maintenance of all Regulatory Materials and Regulatory Approvals for Products in the Field and in the Territory.
(b)
Licensee shall reimburse MTI for all costs and expenses [***] incurred by MTI in the preparation, filing and maintenance of all Manufacturing Development related Regulatory Materials and Regulatory Approvals for Products in the Field and in the Territory.
5.4
Notification of Threatened Action
. Each Party shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority against itself, its Affiliates, or any of its subcontractors or sublicensees (including any Persons in the supply or distribution chain of the Product) as well as any Regulatory Authority, which may materially affect the Development, Commercialization or regulatory status of a Product in the Territory. Upon receipt of such information, the Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.
5.5
Adverse Event Reporting and Safety Data Exchange
. No later than [***] prior to the targeted filing date reasonably set by Licensee of an IND for any Product in the Field and in the Territory, the Parties shall enter into a commercially reasonable pharmacovigilance agreement (the “
Pharmacovigilance Agreement
”). The Pharmacovigilance Agreement shall include customary guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Product, including any and all Safety Data. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Laws. Furthermore, such agreed procedure shall be consistent with relevant guidelines of the International Conference on Harmonisation, except where such guidelines may conflict with existing local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall prevail. The Pharmacovigilance Agreement shall provide for an adverse event database for Products in the Territory to be maintained by Licensee [***]. Licensee shall be responsible for reporting quality complaints, adverse events and safety data related to Products to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Products in the Territory. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees to comply with such obligations.
5.6
Remedial Actions
. Each Party shall notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Product may be subject to any recall, corrective action or other regulatory action with respect to a Product taken by virtue of applicable Laws (a “
Remedial Action
”). The Parties shall assist each other in gathering
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action. Each Party shall, and shall ensure that its Affiliates and sublicensees will, maintain adequate records to permit the Parties to trace the distribution and use
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
of the Products in the Territory. Licensee shall have the right to decide whether any Remedial Action with respect to Products in the Field and in the Territory should be commenced and Licensee shall have the obligation, [***] to control and coordinate all efforts necessary to conduct such Remedial Action for the Field and in the Territory.
5.7
Data Exchange and License
.
(a)
Safety Data
.
(i)
Licensee shall obligate each and every Sublicensee to promptly disclose and make available to Licensee all Safety Data in such Sublicensee’s possession.
(ii)
MTI shall obligate each and every Other Licensee to promptly disclose and make available to MTI all Safety Data in such Other Licensee’s possession.
(iii)
Each Party shall disclose and make available all relevant Safety Data (including Safety Data received pursuant to Sections 5.7(a)(i) or (ii) above) to the other Party on a timely basis taking into account applicable obligations to any Regulatory Authority and/or as may be required by the Pharmacovigilance Agreement.
(iv)
Notwithstanding anything to the contrary, nothing in this Agreement shall restrict (A) MTI from sharing any and all Safety Data with any Other Licensee or (B) Licensee from sharing any and all Safety Data with any Sublicensee. MTI shall have the right to permit Other Licensee to use and disclose any Safety Data to the extent required by the Regulatory Authorities. Licensee shall have the right to permit Sublicensee to use and disclose any Safety Data to the extent required by the Regulatory Authorities.
(b)
Regulatory Data
.
(i)
Licensee will obligate each and every Sublicensee to disclose and make available to Licensee in a timely fashion all Regulatory Data in such Sublicensee’s possession and allow Licensee to disclose such Regulatory Data to MTI and allow further disclosures to any Other Licensees. For clarity, the Sublicensee will be obligated to disclose to Licensee (A) any final study report containing Regulatory Data upon the completion of such final study report, and (B) the underlying raw data supporting such final study report, but only to the extent that such raw data or any sub-analysis of such data are reasonably deemed necessary or appropriate to be directly submitted to a Regulatory Authority.
(ii)
MTI will obligate each and every Other Licensee to disclose and make available to MTI in a timely fashion all Regulatory Data in such Other Licensee’s possession and allow MTI to disclose such Regulatory Data to Licensee and allow further disclosures to any Sublicensees. For clarity, the Other Licensee will be obligated to disclose to MTI (A) any final study report containing Regulatory Data upon the completion of such final study report and (B) the underlying raw data supporting such final study report, but only to the extent that such raw data or any sub-analysis of such data are reasonably deemed necessary or appropriate to be directly submitted to a Regulatory Authority.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
(iii)
Each Party shall disclose and make available all relevant Regulatory Data to the other Party on a timely basis after the receipt of such Regulatory Data, upon the completion of a related final study report and the underlying raw data supporting such final study report, but only to the extent that such raw data or any sub-analysis of such data are reasonably deemed necessary or appropriate to be directly submitted to a Regulatory Authority.
(iv)
MTI may disclose and make available any and all Regulatory Data to any Other Licensee for use in the Development of the Product and Licensee may disclose and make available any and all Regulatory Data to any Sublicensee for use in the Development of the Product. The Regulatory Data of each Party will be considered such Party’s Confidential Information; however, the other Party may use and disclose such Regulatory Data (and allow the same rights to its Sublicensees and Other Licensees, as applicable) to the extent necessary in the Development of the Product consistent with the rights of such other Party.
(c)
MTI Other Data
.
(i)
MTI hereby grants to Licensee during the Term an exclusive, royalty-bearing license, with the right to sublicense solely as provided in Section 2.2, to use and exploit the MTI Data in order to Develop Products in the Field and in the Territory. For clarity, all MTI Data will be considered the Confidential Information of MTI and, except as contemplated in this Section 5.7 with respect to Safety Data and Regulatory Data, Licensee will only have the right to sublicense MTI Data to Data Sharing Sublicensees.
(ii)
MTI shall [***].
(d)
Licensee Other Data
.
(i)
Licensee hereby grants to MTI a non-exclusive fully paid-up, royalty-free, license, with the right to sublicense solely as provided in Section 2.5(b), to use and exploit the Licensee Data in order to Develop Products in the Field outside of the Territory. For clarity, all Licensee Data will be considered the Confidential Information of Licensee and, except as contemplated in this Section 5.7 with respect to Safety Data and Regulatory Data, MTI will only have the right to disclose Licensee Data to Data Sharing Other Licensees.
(ii)
Licensee shall [***].
(e)
Data Exchange
.
(i)
MTI shall, or shall cause its Affiliates to, transfer to Licensee (1) within [***] following the Effective Date an electronic copy of the Data owned or Controlled by MTI or its Affiliates prior to the Effective Date and (2) subject to Section 5.7(a)(iii) and 5.7(b)(iii) with respect to Safety Data and Regulatory Data respectively, within [***] following the end of each calendar quarter during the Term, an electronic copy of the Data Controlled by MTI or its Affiliates which became available during such calendar quarter, but, in each case, [***]. MTI will de-identify any clinical trial data to the extent necessary to permit such transfer. For clarity, the above Data disclosure obligation is limited to the transfer of “final” clinical, pre-
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
clinical or manufacturing related reports, provided MTI will make the relevant underlying Data available to Licensee upon Licensee’s reasonable request.
(ii)
Subject to Section 5.7(a)(iii) and 5.7(b)(iii) with respect to Safety Data and Regulatory Data respectively, Licensee shall, or shall cause its Affiliates to, transfer to MTI within [***] following the end of each calendar quarter during the Term an electronic copy of the Data Controlled by Licensee or its Affiliates which became available during such calendar quarter, but, in each case, subject to and as permitted under the terms of any applicable clinical trial protocol and the consents of trial subjects. Licensee will de-identify any clinical trial data to the extent necessary to permit such transfer. For clarity, the above Data disclosure obligation is limited to the transfer of “final” clinical, pre-clinical or manufacturing related reports, provided Licensee will make the relevant underlying Data available to MTI upon MTI’s reasonable request.
(f)
Right of Reference
.
(i)
MTI hereby grants to Licensee, its Affiliates and Sublicensees a “Right of Reference or Use” as that term is defined in 21 C.F.R. § 314.3(b), and any foreign equivalents, to any and all Regulatory Materials Controlled by MTI or its Affiliates for the Products (including any data and information referenced therein), to be used with respect to Products in the Field and in the Territory. MTI will [***].
(ii)
Licensee hereby grants to MTI, its Affiliates and the Other Licensees a “Right of Reference or Use” as that term is defined in 21 C.F.R. § 314.3(b), and any foreign equivalents, to any and all Regulatory Materials Controlled by Licensee or its Affiliates for the Products (including any data and information referenced therein). Licensee will [***].
(g)
Record Keeping
.
Licensee shall (and shall cause its Affiliates and Sublicensees to) maintain the appropriate records of Data (including, but not limited to, study reports, data sets and source documents) in accordance with applicable Laws to the extent such Data is subject to data exchange under this Section. MTI shall (and shall cause its Affiliates, Merck and Other Licensees to) maintain the appropriate records of Data (including, but not limited to, study reports, data sets and source documents) in accordance with applicable Laws to the extent such Data is subject to data exchange under this Section.
5.8
Established Inspection Records
. Upon Licensee’s request, MTI shall promptly provide to Licensee establishment inspection records for all of the sites where toxicology studies sponsored by MTI or its Affiliates have been or are to be conducted.
ARTICLE 6
COMMERCIALIZATION
6.1
Commercialization Responsibilities
. During the Term, Licensee shall be responsible for all aspects of the Commercialization of each Product in the Field in the Territory, including: (a) developing and executing a commercial launch and pre-launch plan, (b)
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
negotiating with applicable Governmental Authorities regarding the price and reimbursement status of the Product; (c) marketing and promotion; (d) booking sales and distribution and performance of related services; (e) handling all aspects of order processing, invoicing and collection, inventory and receivables; (f) providing customer support, including handling medical queries, and performing other related functions; and (g) conforming its practices and procedures to applicable Laws relating to the marketing, detailing and promotion of Products in the Territory. Licensee shall bear all of the costs and expenses incurred in connection with such Commercialization activities.
6.2
Commercialization Plan
. The strategy for the Commercialization of each Product shall be described in a comprehensive plan that describes the pre-launch, launch and subsequent Commercialization activities for such Product in the Territory (the “
Commercialization Plan
”). Licensee shall submit (a) the initial Commercialization Plan to the JSC no later than [***] prior to the anticipated approval of the NDA in the Territory for each Product and (b) a final Commercialization Plan to the JSC no later than [***] prior to the anticipated approval of the NDA in the Territory for each Product. Licensee shall provide a report regarding activities related to the implementation of the Commercialization Plan at each meeting of the JSC and provide at least [***] an updated Commercialization Plan for each Product.
6.3
Commercial Diligence
. During the Term, Licensee shall use [***] to Commercialize each Product in the Territory. Further, Licensee shall [***].
6.4
[***].
6.5
Non
-
Compete
. Licensee agrees not to, and shall cause its Affiliates and Sublicensees not to, [***] any Competing Product in the Territory prior to or during [***].
ARTICLE 7
MANUFACTURE AND SUPPLY
7.1
Supply Agreements
. The Parties will (a) negotiate in [***], not later than [***] after the Effective Date, and thereafter use [***] enter into a clinical supply agreement for supply of the Product to be used in Licensee’s Development activities in the Territory, and (b) negotiate in [***], not later than [***] in the Territory for the Product, and thereafter use [***] to promptly enter into a commercial supply agreement for supply of the Product to be used in Licensee’s Commercialization activities in the Territory, in each case incorporating the terms detailed on
Exhibit D
(such Agreements, collectively the “
Supply Agreements
”). MTI shall supply all clinical and nonclinical materials and commercial requirements of the MTI Formulations (including Compound) to Licensee during the Term of this Agreement in accordance with the Supply Agreement.
7.2
Licensee Formulations
. Licensee shall have the right to manufacture or have manufactured its Development and commercial requirements of the Licensee Formulations except [***]. MTI shall supply and sell to Licensee, and Licensee shall purchase from MTI,
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
[***] for such Licensee Formulations during the Term except as provided in the Supply Agreements.
7.3
Selection of a Contract Manufacturer
. In the event that MTI plans to retain or change a Third Party contract manufacturer to manufacture the Compound and/or Products, MTI shall [***] notify Licensee and shall provide Licensee with [***].
7.4
Accreditation
. MTI and the Licensee acknowledge that, pursuant to the Japanese Pharmaceutical Affairs Law, MTI and its applicable manufacturing sites, including any test or storage facilities, are required to be accredited as of the time when the Licensee files for Regulatory Approval for Licensed Product in the Territory. In order to obtain such accreditation, [***]. In the case of application by the Licensee on behalf of MTI and/or its contract manufactures, MTI shall provide the Licensee with all documents and information available to MTI and reasonably requested by the Licensee in a timely manner. In the event that MTI makes changes with respect to the following matters after the accreditation, MTI shall notify Licensee within [***]:
(i)
Name or address of the person responsible for the manufacturing establishment;
(ii)
Name of the executives responsible for the services;
(iii)
Name of the manufacturing establishment;
(iv)
Major part of buildings and facilities of the manufacturing establishment; and
(v)
Category and (deemed) accreditation number, when a foreign manufacturer obtains additional accreditations for another category, or discontinues operation of their accredited manufacturing establishment.
7.5
Audits of Manufacturing Facilities by Regulatory Authority
. If a Regulatory Authority in the Territory requests an inspection or audit of MTI’s facilities and/or contract facilities manufacturing a Compound or Product (including any test or storage facilities), MTI shall use its [***] with the Licensee and the Regulatory Authority in fulfilling such request. Following receipt of the final inspection or audit observations of the Regulatory Authority (a copy of which MTI shall provide as soon as possible to the Licensee [***]), MTI shall use [***] to consult with the Licensee and prepare the response to any such observations, in English. [***]. Nothing contained within this Section 7.5 shall restrict either Party from making a timely report to a Regulatory Authority or take other action that it deems to be appropriate or required by applicable Law.
7.6
Audits of Manufacturing Facilities by Licensee
. MTI shall permit the Licensee to perform a standard GMP compliance audit at its manufacturing sites (including any test or storage facilities) relating to Product per year without cause upon reasonable notice during regular business hours. For clarity, MTI shall permit the Licensee to perform GMP compliance
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
audit at the manufacturing site at any time for cause. An audit "for cause" shall mean an audit in response to a regulatory authority audit notice concerning quality system issues or failures.
ARTICLE 8
COMPENSATION
8.1
Initial Payments
.
(a)
Within [***] of the later of (i) the Effective Date and (ii) receipt from MTI of all competed tax documents required for the payment under this Section 8.1, Licensee shall, on behalf of MTI, file an Application Form for Income Tax Convention (together with the original Residence Certificate issued to MTI by the Internal Revenue Service of the USA) with tax authorities in Japan in order to reduce MTI’s tax liability for the amount payable to MTI pursuant to this Section 8.1 (such document shall be referred to as “
Tax Documents
”).
(b)
Within [***] after the later of (i) the Effective Date and (ii) receipt from MTI of Tax Documents, Licensee shall pay to MTI a non-refundable, non-creditable payment of Eleven Million Dollars ($11,000,000) by wire transfer in immediately available funds.
(c)
Within [***] of Licensee’s receipt from MTI of both of (i) all of the IND Enabling Past Clinical Study Reports and (ii) Tax Documents, Licensee shall pay to MTI a non-refundable, non-creditable payment of [***] by wire transfer in immediately available funds.
(d)
Within [***] of both of (i) Licensee’s confirmation on completion of [***] and (ii) Licensee’s receipt from MTI of Tax Documents, Licensee shall pay to MTI a non-refundable, non-creditable payment of [***] by wire transfer in immediately available funds.
8.2
Development Milestone Payments
. Within [***] Licensee shall, on behalf of MTI, [***].
8.3
Commercial Milestone Payments
. Licensee shall make each of the following [***]. For the avoidance of doubt, Licensee's total payment obligation under this Section 8.3 shall not exceed Fifteen Million Dollars ($15,000,000).
|
|
|
[***]
|
[***]
|
[***]
|
Fifteen Million Dollars
($15,000,000)
|
8.4
Royalties
.
(a)
Royalty Rates
. Licensee shall pay to MTI non-refundable, non-creditable royalties on Net Sales of all Products in the Territory during the Royalty Term, as calculated by [***].
(b)
[***]
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
(c)
Royalty Reports and Payments
. Within [***] the end of each calendar quarter, commencing with the calendar quarter in which the First Commercial Sale of any Product is made anywhere in the Territory, Licensee shall provide MTI with a report containing the following information for the applicable calendar quarter, on a Product-by-Product basis: [***].
8.5
Third Party Royalty Offsets
. In the event that during the Royalty Term, Licensee (a) has entered into any agreement with any Third Party to obtain a license to any Patents in the absence of which the composition of matter or utility of a Product would infringe such Patents in the Territory (each, an “
Required Third Party Agreement
”) and (b) makes royalty payments under such Required Third Party Agreements, [***].
8.6
Foreign Exchange
. The rate of exchange to be used in computing the amount of currency equivalent in Dollars of Net Sales invoiced in Japanese Yen shall be made at the closing exchange rate of the last day reported in
The Wall Street Journal
(United States internet edition) over the applicable reporting period (calendar quarter).
8.7
Payment Method; Late Payments
. All payments due to either Party hereunder shall be made in Dollars by wire transfer of immediately available funds into an account in the USA designated by such Party. If a Party does not receive payment of any sum due to it on or before the due date, simple interest shall thereafter accrue on the sum due until the date of payment at the per annum rate of [***] over the then-current prime rate reported in
The Wall Street Journal
(United States internet edition) or the maximum rate allowable by applicable Laws, whichever is lower.
8.8
Records
. Licensee and its Affiliates and Sublicensees shall maintain complete and accurate records in sufficient detail to permit MTI to confirm the accuracy of the calculation of royalty payments for [***] from the end of the calendar year in which the royalty payment was due hereunder. MTI shall have the right to audit such records in accordance with Section 8.9.
8.9
Audits
. For a period of [***] from the end of the calendar year in which a payment was due hereunder, upon [***] prior notice, Licensee shall (and shall require that its Affiliates and Sublicensees) make such records relating to such payment available, during regular business hours and not more often than once each calendar year, for examination by an independent certified public accountant selected by MTI and reasonably acceptable to Licensee, for the purposes of verifying compliance with this Agreement and the accuracy of the financial reports and/or invoices furnish pursuant to this Agreement. The results of any such audit shall be shared by the auditor with both Parties and shall be considered Confidential Information of both Parties. Non-disputed amounts shown to be owed by either Party to the other shall be paid within [***] from the auditor’s report, plus interest (as set forth in Section 8.7) from the original due date. MTI shall bear the full cost of such audit unless such audit discloses underpayment more than [***] of the royalties due in Licensee’s payments, in which case Licensee shall bear the full cost of such audit.
8.10
Taxes
.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
(a)
Taxes on Income
. Each Party shall be solely responsible for the payment of all taxes imposed on its share of income arising directly or indirectly from the efforts of the Parties under this Agreement.
(b)
Tax Cooperation
. The Parties agree to cooperate with one another and use reasonable efforts to reduce or eliminate tax withholding or similar obligations in respect of royalties, milestone payments, and other payments made by Licensee to MTI under this Agreement. To the extent Licensee is required to deduct and withhold taxes on any payment to MTI, Licensee shall pay the amounts of such taxes to the proper Governmental Authority in a timely manner and promptly transmit to MTI an official tax certificate or other evidence of such withholding sufficient to enable MTI to claim credit or deduction for such payment of taxes. MTI shall provide Licensee any completed tax forms that may be reasonably necessary in order for Licensee not to withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty. The Parties acknowledges that said tax forms have to be filed with the Governmental Authority periodically (annually under the regulation as of the Effective Date after the launch of the first Product in Territory for purposes of the royalty and commercial milestone payments hereunder). Each Party shall provide the other with reasonable assistance to enable the recovery, as permitted by applicable Laws, of withholding taxes, value added taxes, or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party bearing such withholding tax or value added tax.
(c)
Taxes Resulting From Licensee Action
. If Licensee is required to make a payment to MTI that is subject to a deduction or withholding of tax, then if such withholding or deduction obligation arises as a result of any failure on the part of Licensee to comply with applicable Laws or filing or record retention requirements, that has the effect of modifying the tax treatment of the Parties hereto, then the sum payable by Licensee (in respect of which such deduction or withholding is required to be made) shall be increased to the extent necessary to ensure that MTI receives a sum, after reduction for any tax benefit, including tax credit, available to MTI arising out of payment of such withholding tax, equal to the sum which it would have received had no such withholding or deduction obligation occurred.
ARTICLE 9
INTELLECTUAL PROPERTY MATTERS
9.1
Ownership
.
(a)
Subject to the licenses granted in Section 2.1 and Section 5.7, as between the Parties, MTI shall own all right, title and interest in and to all MTI Patents, MTI Know-How, MTI Data and MTI Owned Improvement Patents.
(b)
Subject to the licenses granted in Section 2.5 and Section 5.7, as between the Parties, Licensee shall own all right, title and interest in and to all Licensee Data, Licensee Owned Improvement Know-How, and Licensee Owned Improvement Patents.
(c)
Licensee and MTI shall jointly own, in equal, undivided shares (and each Party hereby assigns and agrees to assign to the other Party an equal, undivided interest in), all
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
right, title and interest in the Jointly Owned Improvement Patents. Unless otherwise described in this Agreement, each Party shall be free to practice its rights under the Jointly Owned Improvement Patents and license such rights to a Third Party without permission of or accounting or payment to the other Party. Each Party shall execute all papers and take all actions that the other Party reasonably requests in order to assign to the other Party and evidence its joint ownership right, title, and interest in and to the Jointly Owned Improvement Patents, including without limitation execution of any assignments or other agreements further evidencing such Party’s joint ownership of and rights in the Jointly Owned Improvement Patents.
(i)
MTI hereby grants to Licensee during the Term an exclusive (even as to MTI and its Affiliates), fully paid-up, royalty-free, right and license, with the right to sublicense to Sublicensee, under the Jointly Owned Improvement Patents:
(1)
to use and import, Products in order to Develop Products in the Field and in the Territory, and
(2)
to use, import, offer for sale, sell and have sold Products in order to Commercialize Products in the Field and in the Territory.
For clarity, MTI retains the right under the Jointly Owned Improvement Patents to make and have made the Compound and/or Products in the Territory for Development or Commercialization outside the Territory.
(ii)
Licensee hereby grants to MTI during the Term an exclusive (even as to Licensee and its Affiliates), fully paid-up, royalty-free, irrevocable, perpetual, right and license, with the right to sublicense to Other Licensee, under the Jointly Owned Improvement Patents:
(1)
to use and import Products in order to Develop Products in the Field and outside the Territory, and
(2)
to use, import, offer for sale, sell and have sold Products in order to Commercialize Products in the Field and outside the Territory.
For clarity, Licensee retains the right under the Jointly Owned Improvement Patents (i) to make, have made, import or export the Compound or to make, made, import or export any Product in connection with Licensee Formulations or Licensee’s Back-up Manufacturing Right; (ii) to conduct any non-clinical testing or packaging of the Products within or outside the Territory, whether or not Back-up Manufacturing Rights have been exercised; and (iii) to conduct Development (excluding clinical trials or other human use of the Product) anywhere in the world.
9.2
Third Party Licenses
. Licensee shall be responsible for obtaining rights to any intellectual property controlled by Third Parties which Licensee deems necessary or desirable for further Development and/or Commercialization of Product in the Field and in the Territory.
9.3
Prosecution of Patents
.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
(a)
MTI Prosecuted Patents
.
(i)
As between the Parties, MTI shall have the right to prepare, file, prosecute and maintain, including but not limited to defense against oppositions, invalidation trials and suits for canceling trial decision, the MTI Patents and MTI Owned Improvement Patents in the Territory. MTI shall bear all costs of preparation, filing, prosecution and maintenance of MTI Patents and MTI Owned Improvement Patents. [***].
(ii)
During the Term, if MTI decides to cease the prosecution or maintenance, including but not limited to defense against oppositions, invalidation trials and suits for canceling trial decision, of any MTI Patent in the Territory or any MTI Owned Improvement Patent in the Territory, [***].
(iii)
MTI shall reasonably support Licensee in obtaining registration under the name of Licensee in the Territory of the exclusive license granted to Licensee under this Agreement (except with respect to the right to make, have made Products or use them for non-clinical development in the Territory) as a “Senyo Jisshiken” in accordance with Article 77 of the Japanese Patent Law immediately after the Effective Date with respect to MTI Patents already issued or within [***] after issuance or registration of the relevant MTI Patents in the Territory. For clarity, MTI shall obtain an approval and support of Merck for Licensee to make such registration. Licensee shall cooperate with MTI in deleting such Senyo Jisshiken registration immediately upon expiration of the Term or termination of the Agreement.
(b)
Licensee Owned Improvement Patents
.
(i)
[***].
(c)
Jointly Owned Improvement Patents in the Territory
.
(i)
[***].
(d)
Jointly Owned Improvement Patents outside the Territory
.
(i)
[***].
(e)
Cooperation
. Each Party shall provide the other Party with all reasonable assistance and cooperation, [***], in the patent prosecution efforts provide above in this Section 9.3, including providing any necessary powers of attorney and executing any other required documents or instruments for such prosecution.
9.4
Enforcement of MTI Patents or MTI Owned Improvement Patents
.
(a)
Notification
. If either Party becomes aware of any existing or threatened infringement of the MTI Patents or MTI Owned Improvement Patents in the Field in the Territory, which infringing activity involves the using, making, importing, offering for sale or selling Products or a competitive product or otherwise adversely affects or is reasonably
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
expected to adversely affect the Commercialization of any Product in the Territory, it shall [***] the other Party in writing to that effect and [***].
(b)
Actions Controlled by MTI; Licensee’s Back-Up
Enforcement Right
.
[***].
(c)
Other Infringement
. With respect to any infringement of the MTI Patents or MTI Owned Improvement Patents anywhere in the world other than Infringement, [***].
(d)
Collaboration
. Each Party shall provide to the enforcing Party [***] in such enforcement, at such enforcing Party’s [***]. The enforcing Party shall keep the other Party [***]. The non-enforcing Party shall be entitled to separate representation in such matter [***].
(e)
Settlement
.
(i)
Licensee shall not settle any claim, suit or action that Licensee brings under Section 9.4(b) [***].
(ii)
MTI shall not settle any claim, suit or action in connection with MTI Patents or MTI Owned Improvement Patents in or for the Territory, which such MTI brings under Section 9.4(b) in the Territory or otherwise outside the Territory, [***].
(f)
Expenses and Recoveries
. The term “
Revenue
” includes [***]. The enforcing Party bringing a claim, suit or action under Section 9.4(b) shall be solely responsible for any expenses incurred by such Party as a result of such claim, suit or action. If such Party receives Revenue in such claim, suit or action, such Revenue shall be allocated first to the reimbursement of any expenses incurred by such Party in such litigation (including, for this purpose, a reasonable allocation of expenses of internal counsel) and second to the reimbursement of any expenses incurred by the other Party in such litigation (including, for this purpose, a reasonable allocation of expenses of internal counsel), and any remaining amounts shall be allocated [***].
9.5
Enforcement of Other Improvement Patents
. [***].
9.6
Patents Licensed From Third Parties
. Each Party’s rights under this Article 9 with respect to the prosecution, maintenance and enforcement of any MTI Patent that is licensed by MTI [***] prosecute, maintain and enforce such Patent.
9.7
Infringement of Third Party Rights in the Territory
. Subject to Article 11, if any Product used or sold by Licensee, its Affiliates or Sublicensees becomes the subject of a Third Party’s claim or assertion of infringement of a Patent granted by a jurisdiction within the Territory, Licensee shall [***] notify MTI and [***]. Licensee shall notify and keep MTI apprised in writing of any such action and shall consider and take into account MTI’s reasonable interests and requests regarding such action. Any settlement of such infringement claim that would admit liability on the part of MTI, Merck or any of their respective Affiliates shall be
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
subject to MTI’s prior written approval, such approval not to be unreasonably withheld, conditioned or delayed.
9.8
Patent Extension
. Upon request by Licensee, MTI shall reasonably cooperate (including by filing any applications), at MTI’s expense, to extend the term of any patent within the MTI Patents or MTI Owned Improvement Patents in the Territory. In the event that this Agreement is terminated, Licensee shall co-operate with MTI, to the extent available under applicable law in the Territory, to withdraw any applications, registrations or other filings made to extend the term of any patent within the MTI Patents or MTI Owned Improvement Patents in the Territory within [***] of such termination.
9.9
Trademarks
. Licensee shall have the right to brand the Products in the Territory using Licensee related trademarks and any other trademarks and trade names it determines appropriate for the Products in the Territory (“
Product Marks
”), provided MTI will have the right to review and comment on any Licensee proposed Product Marks sufficiently in advance of Licensee’s adoption or registration of any such proposed Product Marks and Licensee will consider any feedback of MTI in good faith.
ARTICLE 10
REPRESENTATIONS AND WARRANTIES; COVENANTS
10.1
Mutual Representations and Warranties
. Each Party hereby represents and warrants to the other Party as follows:
(a)
Corporate Existence
. As of the Effective Date, it is a company or corporation duly organized, validly existing, and in good standing under the Laws of the jurisdiction in which it is incorporated.
(b)
Corporate Power, Authority and Binding Agreement
. As of the Effective Date or the date of any required approval by its shareholders, (i) it has the power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder; (ii) it has taken all necessary action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (iii) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid and binding obligation of such Party that is enforceable against it in accordance with its terms.
(c)
No Conflict
. As of the Effective Date, the execution and delivery of this Agreement and the performance of such Party’s obligations hereunder do not, in any material respect, conflict with, violate, breach or constitute a default or require any consent that has not been obtained under any contractual obligation or court or administrative order by which such Party is bound.
10.2
Additional Representations and Warranties of MTI
. MTI represents and warrants to Licensee as follows, as of the Effective Date:
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
(a)
Title; Encumbrances
. It has sufficient legal and/or beneficial title, ownership or license, free and clear from any mortgages, pledges, liens, security interests, conditional and installment sale agreements, encumbrances, charges or claims of any kind, of or to the MTI Technology to grant the licenses to Licensee as purported to be granted pursuant to this Agreement;
(b)
Notice of Infringement or Misappropriation
. MTI and its Affiliates have not received any written notice from and they have no knowledge of any Third Party asserting or alleging that any research or Development of the Compound or Products prior to the Effective Date infringed or misappropriated, or Commercialization of the Compound or Products would infringe or misappropriate, the intellectual property rights of such Third Party;
(c)
No Proceeding
. There are no pending, and to MTI’s or its Affiliates’ knowledge, no threatened, adverse actions, suits or proceedings involving MTI Technology, the Compound or the Product;
(d)
[***];
(e)
[***];
(f)
Merck Right of First Negotiation
. Merck’s right of first negotiation under Section 3.07 of the Merck License Agreement has expired with respect to the Compound without being exercised and is not valid as of the Effective Date;
(g)
Merck License Agreement
. Exhibit F hereto is an accurate and complete copy of the Merck License Agreement. The Merck License Agreement has not been amended nor has any material provision thereof been waived by MTI. The Merck License Agreement remains in full force and effect. The “Licensed Compound MK-0594” defined under the Merck License Agreement is the Licensed Compound under this Agreement. MTI has not received any notice of any claimed breach nor is MTI in breach or non-compliance thereunder, including any amounts payable is not in default thereunder nor is there any basis for the termination thereof; and
(h)
Previous Non-clinical and Clinical Studies
. To MTI’s knowledge, MTI has provided Licensee with the complete list of non-clinical studies and clinical studies that have been conducted by Merck, MTI or its Affiliates. Section 1.90 (Past Clinical Study Reports) is the complete list of the Phase 1 Clinical Trials that have been conducted by Merck.
10.3
Mutual Covenants
.
(a)
No Debarment
. In the course of the Development of the Product, each Party shall not use any employee or consultant who has been debarred by any Regulatory Authority, or, to such Party’s knowledge, is the subject of debarment proceedings by a Regulatory Authority. Each Party shall notify the other Party promptly upon becoming aware that any of its employees or consultants has been debarred or is the subject of debarment proceedings by any Regulatory Authority.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
(b)
Compliance
. Each Party and its Affiliates shall comply in all material respects with all applicable Laws in the Development and Commercialization of Products and performance of its obligations under this Agreement, including the statutes, regulations and written directives of the FDA, the EMA and any Regulatory Authority having jurisdiction in the Territory, the FD&C Act, the Prescription Drug Marketing Act, the Federal Health Care Programs Anti-Kickback Law, 42 USAC. 1320a-7b(b), the statutes, regulations and written directives of Medicare, Medicaid and all other health care programs, as defined in 42 USAC. § 1320a-7b(f), and the Foreign Corrupt Practices Act of 1977, each as may be amended from time to time.
10.4
Merck License Agreement
. MTI will not amend or waive any provision of the Merck License Agreement, in any way that materially affects Licensee’s rights hereunder, or elect to terminate the Merck License Agreement without the prior written consent of Licensee
.
MTI shall (i) perform its obligations under the Merck License Agreement, (ii) maintain its rights under the Merck License Agreement in all material respects, (iii) promptly notify Licensee in writing of any written notice threatening termination of the Merck License Agreement and (iv) promptly provide Licensee with a copy of any amendments thereto or waivers thereunder.
10.5
Disclaimer
. Licensee understands that the Compound and Products are the subject of ongoing clinical research and development and that MTI cannot assure the safety or efficacy of any Compound or Product. In addition, MTI makes no warranties except as set forth in this Article 10 concerning the MTI Technology. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY, AND ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.
ARTICLE 11
INDEMNIFICATION
11.1
Indemnification by MTI
. MTI shall indemnify and hold harmless Licensee, its Affiliates and each of their respective directors, officers, employees, and agents (collectively, the “
Licensee Indemnitees
”), from and against all losses, liabilities, damages and expenses, including reasonable attorneys’ fees and costs (collectively, “
Liabilities
”), resulting from any claims, demands, actions or other proceedings by any Third Party (“
Claims
”) to the extent resulting from (a) the breach of any representation, warranty or covenant by MTI under this Agreement or (b) the negligence or willful misconduct of MTI or its agents, Affiliates and contractors or (c) the manufacture, Development, or Commercialization or other disposition of the Products by MTI or its Affiliates or Other Licensees (except those carried out by Licensee or its Affiliates or sublicensees). The foregoing indemnity obligation shall not apply to the extent that (i) the Licensee Indemnitees fail to comply with the indemnification procedures set forth in Section 11.3 and MTI’s defense of the relevant Claims is prejudiced by such failure, or (ii) any
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
Claim arises from, is based on, or results from any activity set forth in Section 11.2(a), 11.2(b) or 11.2(c) for which Licensee is obligated to indemnify the MTI Indemnitees under Section 11.2.
11.2
Indemnification by Licensee
. Licensee shall indemnify and hold harmless MTI, its Affiliates, Merck, and their respective directors, officers, employees, and agents (collectively, the “
MTI Indemnitees
”), from and against all Liabilities resulting from any Claims to the extent resulting from (a) the breach of any representation, warranty or covenant by Licensee under this Agreement, (b) the negligence or willful misconduct of Licensee or its agents, Affiliates and contractors, or (c) the manufacture, Development or Commercialization, or other disposition, of the Products by or on behalf of Licensee or its Affiliates or Sublicensees, including Claims based upon products liability in the Territory or with respect to exercise of Licensee’s right hereunder outside the Territory, except as may be set forth in the Supply Agreements between the Parties with respect to product liability arising from manufacturing defects. The foregoing indemnity obligation shall not apply to the extent that
(i)
the MTI Indemnitees fail to comply with the indemnification procedures set forth in Section 11.3 and Licensee’s defense of the relevant Claims is prejudiced by such failure, or
(ii)
any Claim arises from, is based on, or results from any activity set forth in Section 11.1(a), 11.1(b) or 11.1(c) for which MTI is obligated to indemnify the Licensee Indemnitees under Section 11.1.
11.3
Indemnification Procedures
. The Party claiming indemnity under this Article 11 (the “
Indemnified Party
”) shall give written notice to the Party from whom indemnity is being sought (the “
Indemnifying Party
”) promptly after learning of such Claim. The Indemnifying Party shall have the right to assume and conduct the defense of the Claim with counsel of its choice, and the Indemnified Party may participate in and monitor such defense with counsel of its own choosing at its sole expense. The Indemnified Party shall provide the Indemnifying Party with reasonable assistance, at the Indemnifying Party’s expense, in connection with the defense of the Claim for which indemnity is being sought. Each Party shall not settle or compromise any Claim without the prior written consent of the other Party, which consent shall not be unreasonably withheld, delayed or conditioned. If the Parties cannot agree as to the application of the foregoing Sections 11.1 and 11.2, each may conduct separate defenses of the Claim, and each Party reserves the right to claim indemnity from the other in accordance with this Article 11 upon the resolution of the underlying Claim.
11.4
Limitation of Liability
. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 11.4 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 11.1 OR 11.2, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS IN ARTICLE 12.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
ARTICLE 12
CONFIDENTIALITY
12.1
Confidentiality
. During the Term and for a period of [***] thereafter, each Party shall maintain all Confidential Information of the other Party in trust and confidence and shall not, without the written consent of the other Party, disclose any Confidential Information of the other Party to any Third Party or use any Confidential Information of the other Party for any purpose other than as provided in this Agreement. The confidentiality obligations of this Section 12.1 shall not apply to Confidential Information to the extent that the receiving Party can establish by competent evidence that such Confidential Information: (a) is publicly known prior or subsequent to disclosure without breach of confidentiality obligations by such Party or its Affiliates or their directors, officers, employees, consultants or agents; (b) was in such Party’s possession at the time of disclosure without any restrictions on further disclosure; (c) is received by such receiving Party, without any restrictions on further disclosure, from a Third Party who has the lawful right to disclose it, or (d) is independently developed by the receiving Party who had no access to the disclosing Party’s Confidential Information.
12.2
Authorized Disclosure
. Nothing herein shall preclude a Party from disclosing the Confidential Information of the other Party to the extent:
(a)
such disclosure is reasonably necessary (i) for the filing or prosecuting of Patents as contemplated by this Agreement; (ii) to comply with the requirement of Regulatory Authorities with respect to obtaining and maintaining Regulatory Approval (or any pricing and reimbursement approvals) of a Product; or (iii) for prosecuting or defending litigations as contemplated by this Agreement;
(b)
such disclosure is reasonably necessary to its or its Affiliates’ directors, officers, employees, agents, consultants, contractors, licensees or sublicensees on a need-to-know basis for the sole purpose of performing its obligations or exercising its rights under this Agreement; provided that in each case, the disclosees are bound by written obligations of confidentiality and non-use consistent with those contained in this Agreement;
(c)
such disclosure is reasonably necessary to any bona fide potential or actual investor, acquiror, merger partner, or other financial or commercial partner for the sole purpose of evaluating an actual or potential investment, acquisition or other business relationship; provided that in connection with such disclosure, such Party shall use all reasonable efforts to inform each disclosee of the confidential nature of such Confidential Information and cause each disclosee to treat such Confidential Information as confidential;
(d)
such disclosure is reasonably necessary to comply with applicable Laws, including regulations promulgated by applicable security exchanges, a valid order of a court of competent jurisdiction, administrative subpoena or order.
Notwithstanding the foregoing, in the event a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to Section 12.2(a) or 12.2(d), such Party shall promptly notify the other Party of such required disclosure and shall use reasonable efforts to
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
obtain, or to assist the other Party in obtaining, a protective order preventing or limiting the required disclosure. [***].
12.3
Destruction of Confidential Information
. Promptly after the termination or expiration of this Agreement for any reason, each Party shall destroy all tangible manifestations of such other Party’s Confidential Information at that time in the possession of the receiving Party. The receiving Party shall provide the disclosing Party a certificate attesting to the destruction of such materials.
12.4
Publicity; Terms of the Agreement
.
(a)
The Parties agree that the material terms of this Agreement (including without limitation any exhibits hereto) shall be considered “
Confidential Information
” of each Party, subject to the special authorized disclosure provisions set forth in Section 12.2 and this Section 12.4.
(b)
The Parties have agreed to issue press releases in the forms attached as
Exhibit E
on or promptly after the Effective Date. After release of such press releases, if either Party desires to make a public announcement concerning the material terms of this Agreement, such Party shall give reasonable prior advance notice of the proposed text of such announcement to the other Party for its prior review and approval (except as otherwise provided herein), such approval not to be unreasonably withheld. A Party commenting on such a proposed press release shall provide its comments, if any, within [***] after receiving the press release for review. In addition, to the extent required by applicable Laws, including regulations promulgated by applicable security exchanges, each Party shall have the right to make a press release announcing the achievement of each milestone (but not the amount of the relevant milestone payment) under this Agreement as it is achieved, and the achievements of Regulatory Approvals in the Territory as they occur, subject only to the review procedure set forth in the preceding sentence. In relation to the other Party’s review of such an announcement, such other Party may make specific, reasonable comments on such proposed press release within the prescribed time for commentary, but shall not withhold its consent to disclosure of the information that the relevant milestone has been achieved and triggered a payment hereunder, provided the amount of such payment is not included in such proposed press release. Notwithstanding anything to the contrary in this Section 12.4, neither Party shall be required to seek the permission of the other Party to repeat any information regarding the terms of this Agreement that has already been publicly disclosed by such Party, or by the other Party, in accordance with this Section 12.4, provided such information remains accurate as of such time.
(c)
In addition, the Parties acknowledge that either or both Parties may be obligated to file under applicable Laws and regulation a copy of this Agreement with the USA Securities and Exchange Commission or similar stock exchange authorities or other governmental authorities. Each Party shall be entitled to make such a required filing;
provided
,
however
, that it requests confidential treatment of the commercial terms and sensitive technical terms hereof and thereof to the extent such confidential treatment is reasonably available to such Party. In the event of any such filing, each Party shall provide the other Party with a copy of this Agreement marked to show provisions for which such Party intends to seek confidential
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
treatment and shall reasonably consider and incorporate the other Party’s comments thereon to the extent consistent with the legal requirements, with respect to the filing Party, governing disclosure of material agreements and material information that must be publicly filed.
(d)
MTI shall have the right to disclose the terms of this Agreement to any investor or potential investor in MTI and/or its Affiliates, shareholder or prospective shareholder of MTI and/or its Affiliates, licensee or potential licensee of MTI, or acquirer or potential acquirer of MTI (collectively “
MTI Partners
”). Any such MTI Partners must agree in writing to be bound by confidentiality and non-use obligations essentially the same as those contained in this Agreement. Licensee shall have the right to disclose the terms of this Agreement to any sublicensee or potential sublicensee of Licensee, or acquirer or potential acquirer of Licensee (collectively “
Licensee Partners
”). Any such Licensee Partners must agree in writing to be bound by confidentiality and non-use obligations essentially the same as those contained in this Agreement.
(e)
Notwithstanding anything to the contrary, Licensee may not disclose the Merck License Agreement to any Third Party without the prior written consent of MTI.
12.5
Technical Publication
. Neither Party may publish peer reviewed manuscripts or give other forms of public disclosure such as abstracts and media presentations (such disclosure collectively, for purposes of this Section 12.5, “
publication
”), of results of studies carried out under this Agreement, without the opportunity for prior review by the other Party, except to the extent required by applicable Laws. A Party seeking publication shall provide the other Party the opportunity to review and comment on any proposed publication that relates to the Product at least [***] (or at least [***] in the case of abstracts and media presentations) prior to its intended submission for publication. The other Party shall provide the Party seeking publication with its initial comments in writing, if any, within [***] (or within [***] in the case of abstracts and media presentations) after receipt of such proposed publication. The Party seeking publication shall consider in good faith any comments thereto provided by the other Party and shall comply with the other Party’s reasonable request to remove any and all of such other Party’s Confidential Information from the proposed publication. In addition, the Party seeking publication shall delay the submission for a period up to [***] in the event that the other Party can demonstrate reasonable need for such delay in order to accommodate the preparation and filing of a patent application. If the other Party fails to provide its comments to the Party seeking publication within such [***] (or [***] as the case may be), such other Party shall be deemed not to have any comments, and the Party seeking publication shall be free to publish in accordance with this Section 12.5 after the [***] (or [***], as the case may be) has elapsed. The Party seeking publication shall provide the other Party a copy of the publication at the time of the submission. Each Party agrees to acknowledge the contributions of the other Party and its employees in all publications as scientifically appropriate.
12.6
Equitable Relief
. Each Party acknowledges that its breach of Article 12 of this Agreement may cause irreparable injury to the other Party for which monetary damages may not be an adequate remedy. Therefore, each Party shall be entitled to seek injunctive and other appropriate equitable relief to prevent or curtail any actual or threatened breach of the obligations relating to Confidential Information set forth in this Article 12 by the other Party. The rights and
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
remedies provided to each Party in this Article 12 are cumulative and in addition to any other rights and remedies available to such Party at law or in equity.
ARTICLE 13
TERM AND TERMINATION
13.1
Term
. This Agreement shall become effective on the Effective Date and, unless earlier terminated pursuant to this Article 13, shall remain in effect on a Product-by-Product basis until the expiration of the Royalty Term of such Product in the Territory (the “
Term
”). On expiration in the Territory for a particular Product, the license of Section 2.1 for the Product shall automatically convert to be perpetual, irrevocable and non-exclusive in the Territory.
13.2
Termination by MTI for Patent Challenge
. MTI may terminate this Agreement in its entirety immediately upon written notice to Licensee if Licensee or its Affiliates (directly or indirectly, individually or in association with any other person or entity) challenges the validity, enforceability or scope of any MTI Patents or MTI Owned Improvement Patents anywhere in the world.
13.3
Termination for Breach
.
(a)
Each Party shall have the right to terminate this Agreement in its entirety immediately upon written notice to the other Party if the other Party materially breaches its obligations under this Agreement and, after receiving written notice identifying such material breach in reasonable detail, subject to Section 13.3(b), fails to cure such material breach within [***] from the date of such notice (or within [***] from the date of such notice in the event such material breach is based on the breaching Party’s failure to pay any amounts due hereunder). For clarity, Licensee’s failure to complete the Development Milestone by the deadline contemplated in Section 4.4 will be considered a material breach of this Agreement.
(b)
If the alleged breaching Party disputes in good faith the existence or materiality of a breach specified in a notice provided by the other Party in accordance with Section 13.3 (a), and such alleged breaching Party provides the other Party notice of such dispute within the applicable cure period, then the non-breaching Party shall not have the right to terminate this Agreement under Section 13.3(a) unless and until an arbitrator, in accordance with Article 14, has determined that the alleged breaching Party has materially breached the Agreement and such breaching Party fails to cure such breach within the applicable cure period (measured as commencing after the arbitrator’s decision). It is understood and agreed that during the pendency of such dispute, all of the terms and conditions of this Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations hereunder.
13.4
Termination for Bankruptcy
. To the extent permitted under applicable Laws, if at any time during the Term of this Agreement, an Event of Bankruptcy (as defined below) relating to either Party (the “
Bankrupt Party
”) occurs, the other Party (the “
Non-Bankrupt Party
”) shall have, in addition to all other legal and equitable rights and remedies available hereunder, the option to terminate this Agreement upon [***] written notice to the Bankrupt Party. It is agreed and understood that if the Non-Bankrupt Party does not elect to terminate this
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
Agreement upon the occurrence of an Event of Bankruptcy, except as may otherwise be agreed with the trustee or receiver appointed to manage the affairs of the Bankrupt Party, the Non-Bankrupt Party shall continue to make all payments required of it under this Agreement as if the Event of Bankruptcy had not occurred, and the Bankrupt Party shall not have the right to terminate any license granted herein. The term “
Event of Bankruptcy
” means: (a) filing, in any court or agency pursuant to any statute or regulation of any state or country, (i) a petition in bankruptcy or insolvency, (ii) for reorganization or (iii) for the appointment of (or for an arrangement for the appointment of) a receiver or trustee of the Bankrupt Party or of its assets; (b) with respect to the Bankrupt Party, being served with an involuntary petition filed in any insolvency proceeding, which such petition is not dismissed within [***] after the filing thereof; (c) proposing or being a party to any dissolution or liquidation when insolvent; or (d) making an assignment for the benefit of creditors. Without limitation, the Bankrupt Party’s rights under this Agreement shall include those rights afforded by 11 USAC. § 365(n) of the United States Bankruptcy Code (the “
Bankruptcy Code
”) and any successor thereto. If the bankruptcy trustee of a Bankrupt Party as a debtor or debtor-in-possession rejects this Agreement under 11 USAC. § 365(o) of the Bankruptcy Code, the Non-Bankrupt Party may elect to retain its rights licensed from the Bankrupt Party hereunder (and any other supplementary agreements hereto) for the duration of this Agreement and avail itself of all rights and remedies to the full extent contemplated by this Agreement and 11 USAC. § 365(n) of the Bankruptcy Code, and any other relevant Laws.
13.5
Termination by Licensee
. At any time during the Agreement, Licensee shall have the right to terminate this Agreement in its entirety for any reason by sending [***] of such termination to MTI.
13.6
Effect of Termination
. Upon any termination (but not expiration) of this Agreement, [***]. Without limiting the generality of the foregoing, the following rights and consequences shall apply upon any such termination (but not expiration) (in addition to any other rights and obligations under this Agreement with respect to such termination):
[***].
13.7
Obligations until Termination
. For clarity, Licensee shall continue to perform all obligations under this Agreement with respect to the Development and Commercialization of Products until the effective date of termination and shall not modify in any material respects such activities from past practices during such period.
13.8
Survival
. Termination or expiration of this Agreement shall not affect any rights or obligations of the Parties under this Agreement that have accrued prior to the date of termination or expiration. Notwithstanding anything to the contrary, the following provisions shall survive any expiration or termination of this Agreement: 5.3, 6.5, 8.6, 8.7, 8.8, 8.9, 8. 10, 9.1(a), (b) and (c), 9.3(c) and (d), 10.5, Articles 11, 12, 13, 14, and 15.
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
ARTICLE 14
DISPUTE RESOLUTION
14.1
Disputes
. The Parties recognize that disputes as to certain matters may from time to time arise that relate to either Party’s rights and/or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in this Article 14 to resolve any controversy or claim arising out of, relating to or in connection with any provision of this Agreement, if and when a dispute arises under this Agreement.
14.2
Internal Resolution
. With respect to all disputes arising between the Parties under this Agreement, including any alleged breach under this Agreement or any issue relating to the interpretation or application of this Agreement, if the Parties are unable to resolve such dispute within [***] after such dispute is first identified by either Party in writing to the other, the Parties shall refer such dispute to the Executive Officers of the Parties for attempted resolution by good faith negotiations within [***] after such notice is received, including at least [***] in-person meeting of the Executive Officers or their designated senior executives within [***] after such notice is received.
14.3
Arbitration
. If the Executive Officers of the Parties are not able to resolve such dispute referred to them under Section 14.2 within such thirty (30) day period, then subject to Section 14.4, such dispute shall be settled by binding arbitration in accordance with the then current rules of commercial arbitration of the [***]. A single arbitrator with experience in the development and commercialization of drugs and diagnostics shall be appointed by mutual agreement of the Parties, but failing such agreement, selected in accordance with [***]. The place of arbitration shall be [***]. The arbitrator’s fees and expenses shall be shared equally by the Parties. Each Party shall bear and pay its own expenses incurred in connection with any dispute resolution under this Section 14.3. The proceedings, including any outcome, shall be confidential. Notwithstanding the foregoing, either Party shall have the right, without waiving any right or remedy available to such Party under this Agreement or otherwise, to seek and obtain from any court of competent jurisdiction any interim or provisional relief that is necessary or desirable to protect the rights or property of such Party, pending the selection of the arbitrator hereunder or pending the arbitrator’s decision of the dispute subject to arbitration.
14.4
Patent and Trademark Disputes
. Notwithstanding Section 14.3, any dispute, controversy or claim relating to the scope, validity, enforceability or infringement of any Patent covering the manufacture, use, importation, offer for sale or sale of any Product or of any trademark rights relating to any Product shall be submitted to a court of competent jurisdiction in the country in which such Patent or trademark rights were granted or arose.
ARTICLE 15
MISCELLANEOUS
15.1
MTI’s Change of Control
. In the event that MTI or its Affiliate undergoes a Change of Control to a Competing Company or MTI or its Affiliate acquires control of a
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
Competing Company (except in case that MTI’s Affiliate becomes a Third Party hereunder as the result of such Change of Control), MTI shall (or shall cause its relevant Affiliate and/or Competing Company to) [***].
15.2
Entire Agreement; Amendment
. This Agreement, together with the exhibits attached hereto and which are hereby incorporated herein, represents the entire agreement and understanding between the Parties with respect to its subject matter and supersedes and terminates any prior and/or contemporaneous discussions, representations or agreements, whether written or oral, of the Parties regarding the subject matter hereto, and supersedes, as of the Effective Date, all prior and contemporaneous agreements and understandings between the Parties with respect to the subject matter hereof (including the Prior CDA). There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth in this Agreement. Amendments or changes to this Agreement shall be valid and binding only if in writing and signed by duly authorized representatives of the Parties.
15.3
Force Majeure
. Both Parties shall be excused from the performance of their obligations under this Agreement to the extent that such performance is prevented by force majeure and the nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse shall be continued so long as the condition constituting force majeure continues and the nonperforming Party takes reasonable efforts to remove the condition. For purposes of this Agreement, force majeure shall include conditions beyond the control of the Parties, including an act of God, war, civil commotion, terrorist act, labor strike or lock-out, epidemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe, and failure of plant or machinery (provided that such failure could not have been prevented by the exercise of skill, diligence, and prudence that would be reasonably and ordinarily expected from a skilled and experienced person engaged in the same type of undertaking under the same or similar circumstances). Notwithstanding the foregoing, a Party shall not be excused from making payments owed hereunder because of a force majeure affecting such Party. If a force majeure persists for more than [***], then the Parties shall discuss in good faith the modification of the Parties’ obligations under this Agreement in order to mitigate the delays caused by such force majeure.
15.4
Notices
. Any notice required or permitted to be given under this Agreement shall be in writing, shall specifically refer to this Agreement, and shall be addressed to the appropriate Party at the address specified below or such other address as may be specified by such Party in writing in accordance with this Section 15.4, and shall be deemed to have been given for all purposes (a) when received, if hand-delivered or a reputable courier service, or (b) [***] after mailing, if mailed by first class certified or registered airmail, postage prepaid, return receipt requested.
If to MTI: Menlo Therapeutics Inc.
[***]
With a copy to (which shall not constitute notice):
[***]
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
If to Licensee: Torii Pharmaceutical Co., Ltd.
[***]
and
Japan Tobacco Inc. (Pharmaceutical Division)
[***]
With a copy to (which shall not constitute notice):
[***]
15.5
No Strict Construction; Headings
. This Agreement has been prepared jointly by the Parties and shall not be strictly construed against either Party. Ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision. The headings of each Article and Section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Article or Section. Except where the context otherwise requires, the use of any gender shall be applicable to all genders, and the word “or” is used in the inclusive sense (and/or). The term “including” as used herein means including, without limiting the generality of any description preceding such term.
15.6
Assignment
. Neither Party may assign this Agreement without the prior written consent of the other Party, such consent not to be unreasonably withheld, except that either Party may assign this Agreement without the prior consent of the other Party: (a) to a Third Party successor to all or substantially all of its stock or assets relating to the Product (an “
Acquiror
”), whether in connection with a merger, consolidation or sale of assets or other transaction; or (b) to its Affiliate. Further, MTI may assign without Licensee’s consent its rights to royalties received under this Agreement. Any permitted assignment shall be binding on the successors of the assigning Party. Any successor or assignee of rights and/or obligations permitted hereunder shall,
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
in writing to the other Party, expressly assume performance of such rights and/or obligations. Any attempted or purported assignment in violation of this Section 15.6 shall be null and void.
(a)
The MTI Patents, MTI Owned Improvement Patents, MTI Know-How, MTI Data, MTI Pediatric Formulation, MTI Formulations and MTI Technology shall exclude any Patents and Know-How Controlled by any Acquiror (or any Affiliate thereof, excluding the Party hereto that becomes an Affiliate of the Acquiror as a result of such transaction) prior to the acquisition and which (i) were not obtained from Licensee or its Affiliates or (ii) Cover inventions or comprise Know-How or Data developed outside of and unrelated to any activities under this Agreement.
(b)
The Licensee Patents, Licensee Owned Improvement Patents, Licensee Owned Improvement Know-How and Licensee Data shall exclude any Patents, Data and Know-How Controlled by any Acquiror (or any Affiliate thereof, excluding the Party hereto that becomes an Affiliate of the Acquiror as a result of such transaction) prior to the acquisition and which (i) were not obtained from MTI or its Affiliates or (ii) Cover inventions or comprise Know-How or Data developed outside of and unrelated to any activities under this Agreement.
15.7
Performance by Affiliates
. Each Party may discharge any obligations and exercise any right hereunder through any of its Affiliates. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement, and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Agreement shall be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate.
15.8
Further Actions
. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
15.9
Severability
. If any provision of this Agreement is found by a court of competent jurisdiction to be unenforceable, then such provision shall be construed, to the extent feasible, so as to render the provision enforceable, and if no feasible interpretation would save such provision, it shall be severed from the remainder of this Agreement. The remainder of this Agreement shall remain in full force and effect, unless the severed provision is essential and material to the rights or benefits received by either Party. In such event, the Parties shall negotiate, in good faith, and substitute a valid and enforceable provision or agreement that most nearly implements the Parties’ intent in entering into this Agreement.
15.10
No Waiver
. No provision of this Agreement can be waived except by the express written consent of the Party waiving compliance. Except as specifically provided for herein, the waiver from time to time by either Party of any of its rights or its failure to exercise any remedy shall not operate or be construed as a continuing waiver of same or of any other of such Party’s rights or remedies provided in this Agreement.
15.11
Independent Contractors
. For all purposes under this Agreement, Licensee and MTI are independent contractors with respect to each other, and shall not be deemed to be an
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
employee, agent, partner or legal representative of the other Party. This Agreement does not grant any Party or its employees, consultants or agents any authority (express or implied) to do any of the following without the prior express written consent of the other Party: create or assume any obligation; enter into any agreement; make any representation or warranty; serve or accept legal process on behalf of the other Party; settle any claim by or against the other Party; or bind or otherwise render the other liable in any way.
15.12
Governing Law
. This Agreement shall be governed by the laws of the [***], without regard to its choice of law provisions that would require the application of the laws of a different jurisdiction.
15.13
Counterparts
. This Agreement may be executed in three (3) or more counterparts, each of which shall be deemed an original but all of which together shall constitute the same legal instrument.
[Signature page follows]
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
I
N
W
ITNESS
W
HEREOF
,
the Parties have executed this Agreement by their duly authorized officers as of the Effective Date.
TORII PHARMACEUTICAL CO., LTD. MENLO THERAPEUTICS INC.
|
|
|
|
|
By:
|
/s/ Shoichiro Takagi
|
By:
|
/s/ Steven Basta
|
Name:
|
Shoichiro Takagi
|
Name:
|
Steven Basta
|
Title:
|
President and CEO
|
Title:
|
CEO
|
JAPAN TOBACCO INC.
|
|
|
By:
|
/s/ Muneaki Fujimoto
|
Name:
|
Muneaki Fujimoto
|
Title:
|
President, Pharmaceutical Business
|
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
LIST OF EXHIBITS:
Exhibit A: Letter Agreement
Exhibit B: MTI Patents
Exhibit C
:
Development Plan
Exhibit D: Supply Agreement Key Terms
Exhibit E: Press Releases
Exhibit F: Merck License Agreement
Exhibit G: [***]
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
Exhibit A
Letter Agreement
[***]
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
Exhibit B
[MTI Patents]
[***]
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
Exhibit C
Development Plan
[***]
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
Exhibit D
Supply Agreements Key Terms
[***]
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
Exhibit E
Press Releases
[See Attached]
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
FOR IMMEDIATE RELEASE
Tokyo, August 10, 2016
JT and Torii Sign Exclusive License Agreement with Menlo Therapeutics for Development and Commercialization of NK-1 receptor antagonist in Japan
Japan Tobacco Inc. (JT) (TSE:2914) and Torii Pharmaceutical Co., Ltd. (Torii) (TSE:4551) announced today that the companies have signed an exclusive license agreement with Menlo Therapeutics Inc. (Menlo Therapeutics) for the development and commercialization of serlopitant in Japan.
Serlopitant is a first–in-class, once-daily, oral neurokinin (NK-1) receptor antagonist candidate for the treatment of pruritus. It is expected to suppress pruritus involving the NK-1 signalling pathway. Serlopitant showed antipruritic effects in a phase 2 clinical trial in patients with chronic pruritus conducted by Menlo Therapeutics.
Under the terms of the agreement, JT and Torii will jointly develop serlopitant in Japan
and Torii will be commercializing it, once the development and necessary approval procedures have been completed.
The companies will pay to Menlo Therapeutics
upfront licensing fees and payments upon the achievement of certain milestones,
and royalties based on future sales in Japan.
ABOUT Menlo Therapeutics Inc.
Menlo Therapeutics Inc., formerly Tigercat Pharma, Inc., is a clinical stage pharmaceutical company dedicated to the development of serlopitant, a once-daily oral NK1 antagonist, for the treatment of pruritus. Menlo Therapeutics is funded by leading healthcare investors Vivo Capital (http://vivocapital.com), Presidio Partners (http://presidiopartners.com), Remeditex Ventures, LLC (http://www.remeditex.com) and F-Prime Capital (http://fprimecapital.com). More information is available at http://menlotherapeutics.com/.
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Japan Tobacco Inc. is a leading international tobacco company. Its products are sold in over 120 countries and its globally recognized brands include Winston, Camel, Mevius, LD and Natural American Spirit. With diversified operations, JT is also actively present in pharmaceuticals and processed foods. The company’s revenue was
¥
2.253 trillion (US$18,679 million(*)) in the fiscal year ended December 31, 2015.
*Translated at the rate of
¥
120.61 per $1, as of December 31, 2015
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Contact for Japan Tobacco Inc.:
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Contact for Torii Pharmaceutical Co., Ltd.:
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Ryohei Sugata, General Manager
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Planning Department (Public Relations)
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Media and Investor Relations Division
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Torii Pharmaceutical Co., Ltd.
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Japan Tobacco Inc. Tokyo: +81-3-5572-4292
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Tokyo: +81-3-3231-6814
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E-mail: jt.media.relations@jt.com
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Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
FOR IMMEDIATE RELEASE
Menlo Park, CA. August 10, 2016
Menlo Therapeutics Signs Exclusive License Agreement with Japan Tobacco and Torii Pharmaceuticals for Development and Commercialization of NK-1 receptor antagonist in Japan
Menlo Therapeutics Inc, (Menlo Park, CA) announced today that it has entered into an exclusive license agreement with Japan Tobacco Inc. (JT) (TSE:2914) and Torii Pharmaceutical Co., Ltd. (Torii) (TSE:4551) for the development and commercialization of serlopitant in Japan. Serlopitant is a first–in-class, once-daily oral NK-1 receptor antagonist candidate for the treatment of pruritus. Serlopitant has demonstrated antipruritic effects in a Phase 2 clinical trial in patients with severe, chronic pruritus conducted by Menlo Therapeutics.
Under the terms of the agreement, JT and Torii will jointly develop serlopitant in Japan and Torii will commercialize it, once the development and necessary approval procedures have been completed. The companies will pay to Menlo Therapeutics upfront licensing fees and payments upon the achievement of certain milestones, and royalties based on future sales in Japan.
Serlopitant has been evaluated in a 257-patient randomized, double-blind, placebo-controlled dose-finding Phase 2 clinical trial for the treatment of severe chronic pruritus. All serlopitant treatment groups demonstrated reduced pruritus as compared with the placebo group, with statistically significant improvement seen at the two higher dose levels. Based upon this successful Phase 2 study, Menlo Therapeutics in partnership with JT and Torii is expanding development to multiple clinical populations in which severe pruritus represents a significant unmet clinical need.
“We are delighted to have JT and Torii as our partner in Japan. JT and Torii have significant pruritus development and marketing experience in Japan, and they are the current market leader in pruritus therapy for patients on hemodialysis. Torii also has a strong established position in the Japanese dermatology market. These dual market capabilities make JT and Torii an excellent partner for serlopitant development and commercialization” said Steve Basta, CEO of Menlo Therapeutics.
ABOUT Menlo Therapeutics Inc.
Menlo Therapeutics Inc., formerly Tigercat Pharma, Inc., is a clinical stage pharmaceutical company dedicated to the development of serlopitant, a once-daily oral NK1 antagonist, for the treatment of pruritus. Menlo Therapeutics is funded by leading healthcare investors Vivo Capital (http://vivocapital.com), Presidio Partners (http://presidiopartners.com), Remeditex Ventures, LLC (http://www.remeditex.com) and
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
F-Prime Capital (http://fprimecapital.com). More information is available at http://menlotherapeutics.com/..
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Contact for Menlo Therapeutics:
Steven Basta
Chief Executive Officer
650-430-5777
media@menlotx.com
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
Exhibit F
Merck License Agreement
[***]
Confidential treatment has been sought for portions of this agreement. The copy filed herewithin omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
Exhibit G
[***]
SUBLEASE
THIS SUBLEASE (this “Sublease”) is dated for reference purposes as of September 19, 2017, and is made by and between Relypsa, Inc., a Delaware corporation (“Sublessor”), and Menlo Therapeutics, Inc., a Delaware corporation (“Sublessee”). Sublessor and Sublessee hereby agree as follows:
1.
Recitals
: This Sublease is made with reference to the fact that
HCP LS REDWOOD CITY, LLC,
as landlord (“Master Lessor”), and Sublessor, as tenant, entered into that certain lease, dated as of June 26, 2014 as amended by that First Amendment to Lease, dated as of July 10, 2015 (as amended, the “Master Lease”), with respect to certain premises consisting of approximately 79,675 rentable square feet of space (the “100 Premises”) of a building located at 100 Cardinal Way, Redwood City, California (the “100 Building”) and 13,904 rentable square feet of space (the “200 Premises”) of a building located at 200 Cardinal Way, Redwood City, California (the “200 Building”). A copy of the Master Lease is attached hereto as
Exhibit A
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2.
Premises
:
A.
Subleased Premises
. Sublessor hereby subleases to Sublessee, and Sublessee hereby subleases from Sublessor, the entire 200 Premises (hereinafter, the “Subleased Premises”). The Subleased Premises are more particularly described on
Exhibit B
attached hereto.
3.
Term
:
A.
Term
. The term (the “Term”) of this Sublease shall be for the period commencing upon the later of (a) receipt of Master Lessor’s written consent to this Sublease and (b) October 1, 2017 (the “Commencement Date”), and ending on the last day of the thirtieth (30th) month after the Commencement Date (the “Expiration Date”), unless this Sublease is sooner terminated pursuant to its terms or the Master Lease is sooner terminated pursuant to its terms.
B.
Early Possession
. Upon the full execution and delivery of this Sublease, Sublessor shall permit Sublessee to enter the Subleased Premises solely for the purpose of preparing the Subleased Premises for occupancy and not for the purpose of conducting business therein, provided (i) Master Lessor’s written consent to this Sublease has been received, (ii) Sublessee has delivered to Sublessor the Security Deposit and first month’s Base Rent as required under Paragraph 4 and (iii) Sublessee has delivered to Sublessor evidence of all insurance required under this Sublease. Such occupancy shall be subject to all of the provisions of this Sublease, except for the obligation to pay Base Rent, Direct Expenses and utilities and shall not advance the Expiration Date of this Sublease.
4.
Rent
:
A.
Base Rent
. Sublessee shall pay to Sublessor as base rent for the Subleased Premises for each month during the Term (“Base Rent”):
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Period
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Base Rent
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Commencement Date – Month 12
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$54,225.60
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Month 13 – Month 24
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$55,852.37
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Month 25 – Expiration Date
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$57,527.94
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Base Rent and Additional Rent, as defined in Paragraph 4.B below, shall be paid on or before the first (1st) day of each month. Base Rent and Additional Rent shall be payable without notice or demand
and without any deduction, offset, or abatement, in lawful money of the United States of America. Base Rent and Additional Rent shall be paid directly to Sublessor at the applicable address set forth below Sublessor’s signature to this Sublease or such other address as may be designated in writing by Sublessor.
B.
Additional Rent
. All monies other than Base Rent required to be paid by Sublessor under the Master Lease as to the Subleased Premises, including, without limitation, any amounts payable by Sublessor to Master Lessor as “Direct Expenses” (as defined in Section 4.2.2 of the Master Lease) and costs of utilities under Section 6.1 of the Master Lease, as incorporated herein, with respect to the Subleased Premises shall be paid by Sublessee hereunder as and when such amounts are due under the Master Lease, as incorporated herein. All such amounts shall be deemed additional rent (“Additional Rent”). Base Rent and Additional Rent hereinafter collectively shall be referred to as “Rent”. Sublessee and Sublessor agree, as a material part of the consideration given by Sublessee to Sublessor for this Sublease, that Sublessee shall pay all costs, expenses, taxes, insurance, maintenance and other charges of every kind and nature arising in connection with this Sublease, the Master Lease as to the Subleased Premises, or the Subleased Premises, such that Sublessor shall receive, as a net consideration for this Sublease, the Base Rent payable under Paragraph 4.A hereof. Notwithstanding anything in this Sublease to the contrary, Additional Rent shall not include, and Sublessee shall have no obligation to pay for: (a) any charges that apply solely to the 100 Premises/100 Building (e.g., real estate taxes on leasehold improvements therein), (b) late fees or penalties assessed against Sublessor as a result of Sublessor’s acts or omissions, (c) charges incurred as a result of excess or additional services specifically requested by Sublessor for the 100 Premises/100 Building or for or including the Subleased Premises without Sublessee’s consent or as a result of Sublessee’s actions (including after hours utilities), and (d) the cost of utilities and services consumed by Sublessor in the 100 Premises in excess of the reasonable and normal use of a comparable office user in the Project (such as for labs or server rooms in the 100 Premises/100 Building), in which event Sublessor shall reasonably apportion the utilities portion of the Direct Expenses payable by Sublessee.
C.
Payment of First Month’s Rent
. Upon execution hereof by Sublessee, Sublessee shall pay to Sublessor the sum of Fifty-Four Thousand Two Hundred Twenty-Five and 60/100 Dollars ($54,225.60), which shall constitute Base Rent for the first month of the Term.
5.
Security Deposit
: Upon execution hereof by Sublessee, Sublessee shall deposit with Sublessor the sum of Fifty-Four Thousand Two Hundred Twenty-Five and 60/100 Dollars ($54,225.60) (the “Security Deposit”), in cash, as security for the performance by Sublessee of the terms and conditions of this Sublease. If Sublessee fails to pay Rent or other charges due hereunder or otherwise defaults with respect to any provision of this Sublease (beyond applicable notice and cure periods), then Sublessor may draw upon, use, apply or retain all or any portion of the Security Deposit for the payment of any Rent or other charge in default, for the payment of any other sum which Sublessor has become obligated to pay by reason of Sublessee’s default, or to compensate Sublessor for any loss or damage which Sublessor has suffered thereby. If Sublessor so uses or applies all or any portion of the Security Deposit, then Sublessee, within ten (10) days after demand therefor, shall deposit cash with Sublessor in the amount required to restore the Security Deposit to the full amount stated above. Upon the expiration of this Sublease, if Sublessee is not in default, Sublessor shall return to Sublessee so much of the Security Deposit as has not been applied by Sublessor pursuant to this paragraph, or which is not otherwise required to cure Sublessee’s defaults.
6.
Holdover
: In the event that Sublessee does not surrender the Subleased Premises by the Expiration Date in accordance with the terms of this Sublease, Sublessee shall indemnify, defend, protect and hold harmless Sublessor from and against all loss and liability resulting from Sublessee’s delay in surrendering the Subleased Premises and pay Sublessor holdover rent as provided in Section 16 of the Master Lease, as incorporated herein.
7.
Repairs
: Sublessor shall deliver the Subleased Premises to Sublessee in broom-clean condition. The parties acknowledge and agree that Sublessor has made no representations or warranties with respect to the condition of the Subleased Premises, except as set forth in this section. Sublessor shall have no obligation whatsoever to make or pay the cost of any alterations, improvements or repairs to the
Subleased Premises, including, without limitation, any improvement or repair required to comply with any law. Master Lessor shall be solely responsible for performance of any repairs required to be performed by Master Lessor under the terms of the Master Lease.
8.
Assignment and Subletting
. Sublessee may not assign this Sublease, sublet the Subleased Premises, transfer any interest of Sublessee therein or permit any use of the Subleased Premises by another party (collectively, “Transfer”), without the prior written consent of Sublessor, not to be unreasonably withheld, and Master Lessor; provided, however, notwithstanding Section 18(A) of the Master Lease, Sublessor’s consent shall not be required for a transfer as described in the first sentence of Section 14.8 of the Master Lease, as incorporated herein. Sublessee acknowledges that the Master Lease contains a “recapture” right in Section 14.4. and that Sublessor may withhold consent to a proposed Transfer in its sole discretion unless Master Lessor confirms in writing that the recapture right does not apply to the Subleased Premises or otherwise waives such right. Any Transfer shall be subject to the terms of Section 14 of the Master Lease, as incorporated herein.
9.
Use
: Sublessee may use the Subleased Premises only for general office use, research and development and sales and marketing, and in compliance with, and subject to, applicable laws and the terms of the Master Lease and this Sublease. Sublessee shall not use, store, transport or dispose of any Hazardous Materials (as defined in the Master Lease) in or about the Premises except Hazardous Materials contained in normal office products in accordance with the Master Lease. Sublessee shall comply with all reasonable rules and regulations promulgated from time to time by Sublessor and Master Lessor.
10.
Delivery and Acceptance
: If Sublessor fails to deliver possession of the Subleased Premises to Sublessee on or before the date set forth in Paragraph 3.A hereof for any reason whatsoever, then this Sublease shall not be void or voidable, nor shall Sublessor be liable to Sublessee for any loss or damage; provided, however, that in such event, the Commencement Date shall be delayed until Sublessor delivers possession of the Subleased Premises to Sublessee. By taking possession of the Subleased Premises, Sublessee conclusively shall be deemed to have accepted the Subleased Premises in their as-is, then-existing condition, without any warranty whatsoever of Sublessor with respect thereto, except as otherwise expressly set forth in this Sublease. Notwithstanding the foregoing, if Master Lessor’s consent to this Sublease has not been obtained, and the Subleased Premises have not been delivered to Sublessee, by October 31, 2017, then Sublessee shall have the right, upon written notice to Sublessor, to terminate this Sublease, and upon such termination, Sublessor shall return the Security Deposit and all advance Rent to Sublessee, and the parties shall be released from all liability and obligations hereunder.
11.
Improvements
: No alteration or improvements shall be made to the Subleased Premises, except in accordance with the Master Lease, and with the prior written consent of both Sublessor, not to be unreasonably withheld, and Master Lessor.
12.
Insurance; Waiver of Subrogation
: Sublessee shall obtain and keep in full force and effect, at Sublessee’s sole cost and expense, during the Term, the insurance required under Section 10 of the Master Lease. Sublessee shall name Master Lessor and Sublessor as additional insureds under its liability insurance policy. The release and waiver of subrogation set forth in Section 10.5 of the Master Lease, as incorporated herein, shall be binding on the parties.
13.
Default; Remedies
: Sublessee shall be in material default of its obligations under this Sublease if Sublessee commits any act or omission which constitutes an event of default under the Master Lease, which has not been cured after delivery of written notice and passage of any applicable grace period provided in the Master Lease as modified, if at all, by the provisions of this Sublease. In the event of any material default by Sublessee beyond any applicable notice and cure periods, Sublessor shall have all remedies provided pursuant to Section 19.2 of the Master Lease and by applicable law.
14.
Surrender
: Prior to expiration of this Sublease, Sublessee shall remove all of its trade fixtures and shall surrender the Subleased Premises to Sublessor in good condition, free of Hazardous Materials caused by Sublessee, reasonable wear and tear, casualty and condemnation excepted. If the
Subleased Premises are not so surrendered, then Sublessee shall be liable to Sublessor for all costs incurred by Sublessor in returning the Subleased Premises to the required condition.
15.
Broker
: Sublessor and Sublessee each represent to the other that they have dealt with no real estate brokers, finders, agents or salesmen other than Savills Studley representing Sublessor and Sublessee, in connection with this transaction. Each party agrees to hold the other party harmless from and against all claims for brokerage commissions, finder’s fees or other compensation made by any other agent, broker, salesman or finder as a consequence of such party’s actions or dealings with such agent, broker, salesman, or finder.
16.
Notices
: Unless at least five (5) days’ prior written notice is given in the manner set forth in this paragraph, the address of each party for all purposes connected with this Sublease shall be the applicable address set forth below its signature at the end of this Sublease. All notices, demands or communications in connection with this Sublease shall be (a) personally delivered; or (b) properly addressed and (i) submitted to an overnight courier service, charges prepaid, or (ii) deposited in the mail (certified, return receipt requested, and postage prepaid). Notices shall be deemed delivered upon receipt or refusal to accept delivery. All notices given to Master Lessor under the Master Lease shall be considered received only when delivered in accordance with the Master Lease.
17.
Miscellaneous
: Sublessor has not had an inspection of the Premises performed by a Certified Access Specialist as described in California Civil Code § 1938. A Certified Access Specialist (CASp) can inspect the Subleased Premises and determine whether the Subleased Premises complies with all of the applicable construction-related accessibility standards under state law. Although state law does not require a CASp inspection of the Subleased Premises, the commercial property owner or lessor may not prohibit the lessee or tenant from obtaining a CASp inspection of the Subleased Premises for the occupancy or potential occupancy of the lessee or tenant, if requested by the lessee or tenant. The parties shall mutually agree on the arrangements for the time and manner of the CASp inspection, the payment of the fee for the CASp inspection, and the cost of making any repairs necessary to correct violations of construction-related accessibility standards within the Subleased Premises.
18.
Other Sublease Terms
:
A.
Incorporation by Reference
. Except as set forth below, the terms and conditions of this Sublease shall include all of the terms of the Master Lease and such terms are incorporated into this Sublease as if fully set forth herein, except that: (i) each reference in such incorporated sections to “Lease” shall be deemed a reference to “Sublease”; (ii) each reference to the “Building”, “Premises”, “Lease Term” and “Base Rent” shall be deemed a reference to the “200 Building”, “Subleased Premises”, “Term” and Base Rent under this Sublease, respectively; (iii) each reference to “Landlord” and “Tenant” shall be deemed a reference to “Sublessor” and “Sublessee”, respectively, except as otherwise expressly set forth herein; (iv) with respect to work, services, repairs, restoration, insurance, indemnities, representations, warranties or the performance of any other obligation of Master Lessor under the Master Lease, the sole obligation of Sublessor shall be to request the same in writing from Master Lessor as and when requested to do so by Sublessee, and to use Sublessor’s reasonable efforts (without requiring Sublessor to spend more than a nominal sum) to obtain Master Lessor’s performance; (v) with respect to any obligation of Sublessee to be performed under this Sublease, wherever the Master Lease grants to Sublessor a specified number of days to perform its obligations under the Master Lease, except as otherwise provided herein, Sublessee shall have three (3) fewer days to perform the obligation, including, without limitation, curing any defaults; (vi) with respect to any approval required to be obtained from the “Landlord” under the Master Lease, such consent must be obtained from both Master Lessor and Sublessor, and the approval of Sublessor may be withheld if Master Lessor’s consent is not obtained; (vii) in any case where the “Landlord” reserves or is granted the right to manage, supervise, control, repair, alter, regulate the use of, enter or use the Premises or any areas beneath, above or adjacent thereto, perform any actions or cure any failures, such reservation or right shall be deemed to be for the benefit of
both Master Lessor and Sublessor; (viii) in any case where “Tenant” is to indemnify, release or waive claims against “Landlord”, such indemnity, release or waiver shall be deemed to run from Sublessee to both Master Lessor and Sublessor; (ix) in any case where “Tenant” is to execute and deliver certain documents or notices to “Landlord”, such obligation shall be deemed to run from Sublessee to both Master Lessor and Sublessor; (x) all payments shall be made to Sublessor; and (xi) Sublessee shall pay all consent and review fees set forth in the Master Lease to both Master Lessor and Sublessor and any caps shall apply separately to Master Lessor and Sublessor.
Notwithstanding the foregoing, (a) the following provisions of the Master Lease shall not be incorporated herein: Summary of Basic Lease Information, Sections 1.1.1 (the first two sentences and last two sentences), 1.1.2 (the first sentence), 1.2, 1.3, 2.1 (the first sentence), 2.2, 4.6, 5.3.1.4.3, 6, 7, 8.1 (the second sentence), 8.5 (the last four sentences), 14.8, 18 (first and third sentences), 21, 23.1, 29.18 and 29.24 and Exhibits B and F-H, and the First Amendment to Lease (except the addition of 200 Premises/200 Building, Section 8 and Exhibit C, but not incorporating the last sentence of Section 6.2 or Section 7.3 of Exhibit C); (b) references in the following provisions to “Landlord” shall mean Master Lessor only: Sections 1.1.2(iv), 1.1.3, 4.2.4, 4.3, 8.4 (the last reference in the first sentence), 10.2, 11.1 (the second and third sentences), 11.2 (except the last reference), 13 (the first sentence), 29.26 (the first sentence), 29.29, and the First Amendment to Lease Exhibit C Sections 6.1 (the first sentence and the first reference in the last sentence), 6.4 (the second sentence), and 7.2; (c) references in the following provisions to “Landlord” shall mean Master Lessor and Sublessor: Sections 4.5, 5.3.1.2-4, 5.3.2, 10.4, 17, 24 (the third sentence) and 26.2, and the First Amendment to Lease Exhibit C Section 6.1 (the fifth sentence); (d) references to the “Permitted Use” shall mean the use permitted under Section 9 above; (e) the number of parking spaces in Section 9 of the Summary of Basic Lease Information (as referenced in Section 28 of the Master Lease) shall be 48; (f) Tenant’s Share shall mean 16.61% as to the Building; (g) subject to Master Lessor’s approval, Sublessor agrees that Menlo Therapeutics is not an Objectionable Name; and (h) in Section 14.3, Sublessee shall pay Sublessor the entire premium payable to Master Lessor under the Master Lease, plus fifty percent (50%) of any remaining Transfer Premium.
B.
Assumption of Obligations
. This Sublease is and at all times shall be subject and subordinate to the Master Lease and the rights of Master Lessor thereunder. Sublessee hereby expressly assumes and agrees: (i) to comply with all provisions of the Master Lease which are incorporated hereunder; and (ii) to perform all the obligations on the part of the “Tenant” to be performed under the terms of the Master Lease during the Term of this Sublease which are incorporated hereunder. In the event the Master Lease is terminated for any reason whatsoever, this Sublease shall terminate simultaneously with such termination without any liability of Sublessor to Sublessee, unless such termination is a result of a Sublessor default thereunder, which default is not due to Sublessee’s act or omission. In the event of a conflict between the provisions of this Sublease and the Master Lease, as between Sublessor and Sublessee, the provisions of this Sublease shall control. In the event of a conflict between the express provisions of this Sublease and the provisions of the Master Lease, as incorporated herein, the express provisions of this Sublease shall prevail.
C.
Preservation of Sublease
. Sublessor covenants that, unless Master Lessor agrees to allow Sublessee to remain in the Subleased Premises for substantially the remainder of the Term of this Sublease on substantially the same terms as this Sublease after any termination of the Master Lease as to the Subleased Premises, it will maintain in effect the Master Lease as to the Subleased Premises during the entire Term of this Sublease, subject, however, to any earlier termination of the Master Lease without the fault of Sublessor or due to a termination pursuant to an exercise by Sublessor or Master Lessor of an express termination right in the Master Lease. Subject to the foregoing, Sublessor further agrees to comply with or perform or cause to be performed Sublessor’s obligations under the Master Lease with respect to the Subleased Premises not assumed or agreed to be performed by Sublessee hereunder (collectively, “Sublessor’s Remaining Obligations”), and to indemnify Sublessee against and hold Sublessee harmless from all claims arising out of (i) Sublessor’s failure to comply with or perform Sublessor’s Remaining Obligations, and (ii) termination or forfeiture of the Master Lease resulting from Sublessor’s default thereunder, which default is not due to Sublessee’s act or omission. Sublessor shall,
upon Sublessee’s written request, use commercially reasonable efforts to cause the Master Lessor to perform its obligations under the Master Lease, without requiring Sublessor to expend more than a nominal sum. Sublessor hereby covenants, except as permitted in this Paragraph 18(C) above, (A) not to voluntarily surrender the Master Lease to Master Lessor as to the Subleased Premises, and (B) not enter into any amendment or other agreement with respect to the Master Lease that will prevent or adversely affect the use by Sublessee of the Subleased Premises in accordance with the terms of this Sublease, materially increase the obligations of Sublessee or materially decrease the rights of Sublessee under this Sublease, materially shorten the term of this Sublease or materially increase the rental or any other sums required to be paid by Sublessee under this Sublease.
19.
Conditions Precedent
: This Sublease and Sublessor’s and Sublessee’s obligations hereunder are conditioned upon the written consent of Master Lessor. If Sublessor fails to obtain Master Lessor’s consent by October 31, 2017, then Sublessor or Sublessee may terminate this Sublease by giving the other party written notice thereof, and Sublessor shall return to Sublessee its payment of the first month’s Rent paid by Sublessee pursuant to Paragraph 4 hereof and the Security Deposit.
20.
Termination; Recapture
: Notwithstanding anything to the contrary herein, Sublessee acknowledges that, under the Master Lease, both Master Lessor and Sublessor have certain termination and recapture rights, including, without limitation, in Sections 11, 13 and 14. Nothing herein shall prohibit Master Lessor or Sublessor from exercising any such rights and neither Master Lessor nor Sublessor shall have any liability to Sublessee as a result thereof. In the event Master Lessor or Sublessor exercise any such termination or recapture rights, this Sublease shall terminate without any liability to Master Lessor or Sublessor.
21.
Parking and Signage
. Sublessee shall have the right to park in 48 unreserved parking spaces in the parking facility that serves the 200 Building as provided in Section 28 of the Master Lease, as incorporated herein. Subject to Master Lessor’s and Sublessor’s consent, Sublessee, at Sublessee’s sole cost and expense, shall have the right to place building standard suite signage at the entrance of the Subleased Premises as well as in the lobby directory.
22.
Furniture, Fixtures and Equipment
: Sublessee shall have the right to use during the Term the furnishings within the Subleased Premises which are identified on
Exhibit C
attached hereto (the “Furniture”) at no additional cost to Sublessee. The Furniture is provided in its “AS IS, WHERE IS” condition, without representation or warranty whatsoever. Sublessee shall insure the Furniture under the property insurance policy required under the Master Lease, as incorporated herein, and pay all taxes with respect to the Furniture. Sublessee shall maintain the Furniture in the condition and repair existing as of the date hereof, reasonable wear and tear excepted, and shall be responsible for any loss or damage to the same occurring during the Term. Sublessee shall surrender the Furniture to Sublessor upon the termination of this Sublease in the same condition as exists as of the date hereof, reasonable wear and tear excepted. Sublessee shall not remove any of the Furniture from the Subleased Premises. Notwithstanding anything to the contrary herein or in the Master Lease, Sublessor shall not be required to provide any personal property (other than the Furniture) or any data-related service to Sublessee.
IN WITNESS WHEREOF, the parties have executed this Sublease as of the day and year first above written.
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SUBLESSOR:
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SUBLESSEE:
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Relypsa, Inc.,
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Menlo Therapeutics, Inc.,
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a Delaware corporation
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a Delaware corporation
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By:
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/s/ Scott Garland
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By:
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/s/ Steven Basta
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Name:
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Scott Garland
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Name:
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Steven Basta
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Its:
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President
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Its:
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Chief Executive Officer
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Address for Notices:
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Address for Notices:
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Before the Commencement Date:
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Before the Commencement Date:
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Relypsa, Inc.
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Menlo Therapeutics Inc.
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Attn: General Counsel
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[***]
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[***]
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After the Commencement Date:
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After the Commencement Date:
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Relypsa, Inc.
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Menlo Therapeutics Inc.
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Attn: General Counsel
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[***]
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[***]
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Address for Payments:
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[***]
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EXHIBIT A
MASTER LEASE
[***]
EXHIBIT B
SUBLEASED PREMISES
[***]
EXHIBIT C
FURNITURE
[***]
Exhibit 10.7
Tigercat Pharma, Inc.
400 Oyster Point Boulevard, Suite 202
South San Francisco, CA 94080
August 17, 2015
Steven
L.
Basta
[***]
[***]
Dear Steve:
We are pleased to confirm our offer to you of employment with Tigercat Pharma, Inc., a Delaware corporation (the "
Company
"), in the position of President and Chief Executive Officer.
Position.
As Chief Executive Officer, you will be responsible for managing the day to day
operations and strategy of the Company and you will report directly to the Board of Directors of the Company. In addition, you will be appointed to the Board of Directors upon your commencement of employment, and will retain a seat on the Board of Directors for the duration of your employment with the Company. It is anticipated that your employment with the Company will begin the week of September 1, 2015, it being understood that this date will be confirmed following discussions with your current employer. In connection with your employment you will enter into an indemnification agreement with customary terms and conditions. The Company will at all times keep in full force directors and officers insurance, and such other insurance as is customary similarly situated companies, as determined by the Board of Directors in its reasonable discretion with the advice of counsel and the Company's insurance broker.
You agree to devote your full business time and attention to your work for the Company. Except upon the prior written consent of the Board of Directors, you will not, during your employment with the Company, (i) accept or maintain any other employment, (ii) engage, directly or indirectly, in any other business activity (whether or not pursued for pecuniary advantage) that might reasonably be expected to interfere with your duties and responsibilities as a Company employee or create a conflict of interest with the Company, (iii) serve on the board of directors of any other company, except for your current directorships at AlterG, Inc. (including a possible role as chairman of the Board), Carbylan Therapeutics Inc., and RF Surgical Systems, Inc. Notwithstanding the foregoing it is agreed that you may (a) provide transition services to AlterG for not more than six (6) months from the commencement of your employment with the Company and for not more than ten percent (10%) of your business time overall, and (ii) provide consulting services to other entities, including current arrangements with Neodyne and SpindleTop, that are not competitive with the Company, not to exceed five percent (5%) of your business time in the aggregate;
provided that
in no event will these consulting services materially interfere with, conflict with or prevent performance of your obligations to the Company pursuant to this letter agreement or any proprietary information agreement.
Salary.
Your initial base salary will be $545,000 per year, less applicable withholdings. Your salary will be reviewed from time to time by the Board of Directors or its compensation committee, and may be adjusted in the sole discretion of the Board of Directors or its compensation committee.
Equity Award.
Promptly after the start of your employment with the Company, the Board of Directors will grant you an option to purchase a number of shares of Common Stock of the Company equal to six percent (6%) of the then current fully diluted number of shares of Common Stock, including shares available for issuance pursuant to the Company's 2011 Stock Incentive Plan (the
"Plan"
) and assuming the exercise and/or conversion of all outstanding securities that are exercisable and/or convertible, directly or indirectly, for Common Stock (such calculation the "Fully-Diluted Capitalization") (after giving effect to such grant). The exercise price of such option will be the fair market value of the Company's Common Stock on the date of grant, as determined by the Board of Directors based on an independent valuation intended to satisfy the safe harbor requirements of Section 409 A of the Internal Revenue Code. If no recent independent valuation has been completed as of the start of your employment, your option grant will still be approved promptly after the start date of your employment with the Company (the
"Start Date"
), subject to determination of the exercise price to be later established by the Board of Directors based on the valuation's assessment of the fair market value of the Company's Common Stock as of the date of grant. The options shall vest with respect to 25% of the total number of shares on the one-year anniversary of your Start Date, and thereafter with respect to 1I48
th
of the total number of shares on each monthly anniversary of your Start Date. Vesting will also accelerate with respect to 100% of the remaining unvested shares on the consummation of a "change of control" transaction, as will be defined in your option agreement with the Company. The option shall be subject to the terms and conditions of the Plan and the option agreement to be entered between you and the Company. The Company will also provide you the opportunity to exercise your option with respect to unvested shares, subject to a "reverse vesting" schedule for the Company to repurchase unvested shares at the option exercise price according to the schedule set forth above.
It is currently contemplated that the existing investors of the Company will provide a bridge financing in the amount of not less than $10,000,000 within thirty days of the date hereof and that the Company will actively seek funding in an private equity financing with one or more closings during the twelve (12) months following the commencement of your employment (the
"Financing"
).
Following each closing of the Financing, you will be granted an additional option under the Plan if required such that your total ownership potential for all equity or options issued under the Plan represents at least the Target Post Financing Ownership Percentage of the Fully Diluted Capitalization (after giving effect to such grant). For these purposes, the
"Target Post Financing Ownership Percentage"
equals (x) 5.7% plus (y) (a) 0.10% times (b) the excess of the Financing Pre Money Valuation over $50,000,000 divided by (c) $10,000,000. The vesting schedule of such additional grant will commence as of your employment and will otherwise have the same terms and conditions as your original option grant, it
being understood that the exercise price will be the fair market value of the Common Stock on the date of grant.
The table below shows several examples of this calculation:
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Financing
Pre Money Valuation
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Set %
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Incremental %
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Target Post Financing
Ownership Percentage
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$50,000,000.00
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5.70%
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0
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%
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5.70%
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$55,000,000.00
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5.70%
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0.05
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%
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5.75%
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$60,000,000.00
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5.70%
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0.10
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%
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5.80%
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$65,000,000.00
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5.70%
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0.15
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%
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5.85%
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$70,000,000.00
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5.70%
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0.20
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%
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5.90%
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$85,000,000.00
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5.70%
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0.35
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%
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6.05%
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$90,000,000.00
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5.70%
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0.40
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%
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6.10%
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$100,000,000.00
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5.70%
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0.50
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%
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6.20%
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For these purposes, the Financing Pre Money Valuation means the Fully-Diluted Capitalization of the Company immediately before the first closing of the Financing multiplied by the price per share paid in the Financing for each share of Common Stock issued or issuable on conversion of the equity issued in the Financing (plus any increase in the number of shares reserved for issuance under the company's equity incentive plans in connection with the Financing).
Benefits:
You will be eligible to participate in the benefits made generally available by the
Company to its senior executives, in accordance with the benefit plans established by the Company, and as may be amended from time to time in the Company's sole discretion. Without limiting the foregoing, you will be entitled to: (i) if and when the Company is offering health insurance to its employees, paid health insurance benefits for you and your immediate family 100% of the premium for which will be paid in full by the Company or (ii) otherwise, prompt reimbursement of 100% of all health insurance premiums incurred by you to obtain health insurance for you and your immediate family with terms and conditions consistent with your position as a senior executive of the company (including without limitation any insurance made available to you by COBRA) as applicable under (i) or (ii),
"Health Insurance Benefits").
The Health Insurance Benefits shall be deemed taxable compensation paid by the Company to you if such payments would constitute a discriminatory benefit under Internal Revenue Code Section 105(h) absent such tax treatment.
You are entitled to paid holidays and vacation days each year, in an amount determined in accordance with and subject to the Company's applicable policies in effect, and as may be amended from time to time. Unless another number is established by the Board in its sole discretion as applicable to all Company executives, you will be entitled to twenty (20) days of vacation per calendar year, which will be pro-rated for any year in which you are only employed with the Company for a portion of the year or for any period in which you are not a full-time employee. Any unused portion of your yearly paid
vacation will carry over to the following year; provided that the maximum accrual of vacation days is twenty (20). Subject to the foregoing limits, all remaining vacation that has accrued but was unused will be paid within ten (10) days following your separation from service based on Executive's base salary in effect on the date of such separation.
At-Will Employment; Severance:
The Company is an "at-will" employer. Accordingly, either
you or the Company may terminate the employment relationship at any time, with or without advance notice, and with or without cause. Upon any termination of your employment, you will be deemed to have resigned, and you hereby resign, from the Company's Board of Directors and from all offices and directorships then held with the Company or any subsidiary. In the event the Company terminates your employment without Cause,l or you terminate your employment for Good Reason,2 you will be eligible to receive (i) an amount equal to the base salary that would have been earned during the Severance Period (defined below) in one lump sum, (ii)
_______________________
¹ For purposes of this paragraph, "
Cause
" means if it that has caused or is reasonably expected to result in material injury to the Company: (i) your gross negligence or willful failure substantially to perform your duties and responsibilities to the Company or deliberate violation of a Company policy; which failure is not corrected within 30 days after the Board of Directors has given you written notice specifYing the failure in reasonable detail, and you have had an opportunity to address the Board of Directors with, at your option, counsel present, (ii) your intentional commission of any act of fraud, embezzlement or dishonesty against the Company or any other willful misconduct; (iii) your improper, unauthorized use or disclosure of any proprietary information or trade secrets of the Company or any other party to whom you owe an obligation of nondisclosure as a result of your relationship with the Company; or (iv) your willful breach of any material obligations under any written agreement or covenant with the Company, which failure is not corrected within 30 days after the Board of Directors has given you written notice specifYing the failure in reasonable detail, and you have had an opportunity to address the Board of Directors with, at your option, counsel present.
² For the purposes of this paragraph, "Good Reason" means the occurrence at any time of any of the following without your prior written consent: (a) removal from the position of Chief Executive Officer with respect to the Company resulting in the material diminution in your authority, duties or responsibilities (other than a mere change in title following any merger or consolidation of the Company with another entity); (b) the assignment of duties or responsibilities materially inconsistent with those customarily associated with the position of Chief Executive Officer or a material diminution of your position, authority, duties or responsibilities (other than a mere change in title following any merger or consolidation of the Company with another entity); (c) a material reduction in your base salary; (d) any willful failure or willful breach by the Company of any of the material obligations of this Agreement or (e) a requirement that you relocate your principal place of business by more than fifty (50) miles. For purposes of this subsection, no act, or failure to act, on the Company's part shall be deemed "willful" unless done, or omitted to be done, by the Company not in good faith and without reasonable belief that the Company's act, or failure to act, was in the best interest of the Company. You may terminate your employment under this Agreement for Good Reason at any time on or prior to the 180th day after the initial occurrence of any of the foregoing Good Reason events; provided, however, that, within ninety (90) days of any such events having first occurred, you shall have provided the Company with notice that such event(s) have occurred and afforded the Company thirty (30) days to cure same
continuation of your Health Insurance Benefits during the Severance Period, and (iii) accelerated vesting with respect to the number of shares underlying any equity incentives or options that are subject to vesting and that would have otherwise vested during the Severance Period had you remained an employee of the Company (collectively,
"Severance Benefits"
).
Your eligibility for these Severance Benefits is conditioned upon your execution of a release of claims in a form provided by the Company with a general release of claims as set forth in Exhibit A (the
"Release"
) within forty-five (45) days following your termination date and your non-revocation of the Release during any applicable statutory revocation period. If you comply with these conditions, the Severance payments will commence on the sixtieth (60th) day following your termination date. For the purposes hereof, the
"Severance Period"
will equal six (6) months for a termination occurring within the first six (6) months after your Start Date, and thereafter will equal the number of full months between the Start Date and the date of termination, up to a maximum of twelve (12) months.
Taxes:
All amounts paid under this letter shall be paid less all applicable state and federal tax withholdings (if any) and any other withholdings required by any applicable jurisdiction or authorized by you. Notwithstanding any other provision of this letter whatsoever, the Company, in its sole discretion, shall have the right to provide for the application and effects of Section 409 A of the Code (relating to deferred compensation arrangements) and any related administrative guidance issued by the Internal Revenue Service. The Company shall have the authority to delay the payment of any amounts under this Agreement to the extent it deems necessary or appropriate to comply with Section 409A(a)(2)(B)(i) of the Code (relating to payments made to certain "key employees" of publicly-traded companies); in such event, any such amount to which you would otherwise be entitled during the six (6) month period immediately following your termination of employment with the Company will be paid in a lump sum on the date six (6) months and one (1) day following the date of your termination of employment with the Company (or the next business day if such date is not a business day), provided that you have complied with the requirements for such payment. You shall be treated as having a termination of employment under this Agreement only if such termination meets the requirements of a "separation from service" as that term is defined in Section 409A(a)(2)(A)(i) of the Internal Revenue Code of 1986, as amended (the
"Code"
) and Treas. Regs. Section 1.409A-1(h), and as amplified by any other official guidance. This Agreement is intended to comply with the provisions of Code Section 409A; provided, however, that the Company makes no representation that the amounts payable under this Agreement will comply with Code Section 409A and makes no undertaking to prevent Code Section 409A from applying to amounts payable under this Agreement or to mitigate its effects on any deferrals or payments made under this Agreement.
In the event that the severance and other benefits provided for in this offer letter or otherwise payable to you (i) constitute "parachute payments" within the meaning of Section 280G of the Code, and (ii) but for this paragraph would be subject to the excise tax imposed by Section 4999 of the Code (the
"Excise Tax"
), then your benefits under this offer letter shall be either (a) delivered in full, or (b) delivered as to such lesser extent which would result in no portion of such benefits being subject to the Excise Tax, whichever of the foregoing amounts, taking into account the applicable federal, state and local income taxes and the Excise Tax, results in the receipt by you on an after-tax basis, of the greatest amount of benefits, notwithstanding that all or some portion of such benefits may be taxable under Section 4999 of the Code.
Expenses.
You are entitled to receive prompt reimbursement for all reasonable fees and
expenses you incur in performing services to the Company, in accordance with the policies and procedures then in
effect and established by the Company for its senior executive officers. In addition, upon execution hereof, you will be reimbursed up to $5,000.00 in legal expenses you incur in connection with this agreement. You are also entitled to receive prompt reimbursement for all reasonable fees and expenses you incur (not to exceed $5,000.00 in any specific instance unless otherwise approved by the Board of Directors in it is good faith judgment as to the reasonableness of any such fees): (i) in connection with any amendment, waiver or termination of this agreement or (ii) in connection with the review and execution of any other agreement you are being asked by the Company to sign in your personal, individual capacity. Reimbursement payments must be made by December 31 of the year following the year in which the expense was incurred, and you must submit all documentation prior to such date.
Entire Agreement.
Please let us know of your decision to join the Company by signing a copy
of this offer letter and returning it to us not later than August 19
1
\ 2015. This letter sets forth our entire agreement and understanding regarding the terms of your employment with the Company and supersedes any prior representations or agreements, whether written or oral. This letter may not be modified in any way except in a writing signed by a duly authorized member of the Company's Board of Directors and you. It shall be governed by California law, without regard to principles of conflicts of laws. Your employment is contingent upon your execution of the Company's Proprietary Information and Invention Assignment Agreement.
Sincerely,
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/s/ James W. Larrick
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James W. Larrick
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ACCEPTED AND AGREED:
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/s/ Steven L. Basta
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Steven L. Basta
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Aug. 18, 2015
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Date
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Exhibit A
Release Language:
You ("Executive") shall release the Company'sParties, as applicable, as set forth below.
Executive agrees, for himself, his spouse, heirs, executor or administrator, assigns, insurers, attorneys, and other persons or entities acting or purporting to act on his behalf (the
"
Executive'sParties
"
), to irrevocably and unconditionally release, acquit, and forever discharge the Company, its affiliates, subsidiaries, directors, officers, employees, shareholders, partners, agents, representatives, predecessors, successors, assigns, insurers, attorneys, benefit plans sponsored by the Company, and said plans' fiduciaries, agents and trustees (the
"
Company'sParties
"
), from any and all actions, causes of action, suits, claims, obligations, liabilities, debts, demands, contentions, damages, judgments, levies, and executions of any kind, whether in law or in equity, known or unknown, which the Executive's Parties have, have had, or may in the future claim to have against the Company's Parties as of [termination date]. This release specifically includes without limitation any claims arising in tort or contract, any claim based on wrongful discharge, any claim based on breach of contract, any claim arising under federal, state or local law prohibiting race, sex, age, religion, national origin, handicap, disability, or other forms of discrimination, any claim arising under federal, state, or local law concerning employment practices, and any claim relating to compensation or benefits. This specifically includes, without limitation, any claim that the Executive has or has had under Title VII of the Civil Rights Act of 1964, as amended, the Age Discrimination in Employment Act, as amended, the Americans with Disabilities Act, as amended, and the Employee Retirement Income Security Act of 1974, as amended. Notwithstanding the foregoing, it is understood and agreed that the waiver of benefits and claims contained in this section does not include a waiver of the right to payment of any vested, nonforfeitable benefits to which the Executive or a beneficiary of the Executive may be entitled under the terms and provisions of any employee benefit plan of the company which have accrued as of the Date of Termination, and does not include a waiver of the right to benefits and payment of consideration to which Executive may be entitled under this Agreement or any of the agreements contemplated by this Agreement (including the indemnification agreement and the stock option agreement).
Executive hereby acknowledges his understanding that under this Agreement he is releasing any known or unknown claims he may have. He therefore acknowledges that he has read and understands Section 1542 of the California Civil Code, which reads as follows:
"A general release does not extend to claims which the creditor does not know or suspect to exist in his favor at the time of executing the release, which if known by him must have materially affected his settlement with the debtor."
Executive expressly waives and relinquishes all rights and benefits under that section and any law of any jurisdiction of similar effect with respect to his release of claims.
Exhibit 10.8
T
igercat Pharma, Inc.
3 Twin Dolphin Drive, Suite 260
Redwood City, CA 94065
January 14, 2016
Paul Kwon, MD
[***]
Dear Paul:
I am pleased to extend to you an offer of employment with Tigercat Pharma, Inc. (the "Company"), in the position of Chief Medical Officer.
Salary.
Your initial base salary will be $350,000 per year, less applicable withholdings. Your salary will be reviewed from time to time by the Board of Directors or its compensation committee, and may be adjusted in the sole discretion of the Board of Directors or its compensation committee.
Bonus.
The Company will establish, in cooperation with you, objectives for your activities annually. The Company will evaluate your achievement of those objectives annually and you will be eligible for an annual bonus of up to 30% of your base salary.
Equity Award.
After the start of your employment with the Company, the Board of Directors will grant you an option to purchase shares of Common Stock of the Company representing 1.4% of the fully diluted shares outstanding of the company pursuant to the Company's 2011 Stock Incentive Plan (the "
Plan
"). The exercise price of such option will be the fair market value of the Company's Common Stock on the date of grant, as determined by the Board of Directors based on an independent valuation intended to satisfy the safe harbor requirements of Section 409A of the Internal Revenue Code. The options shall vest with respect to 25% of the total number of shares on the one-year anniversary of your start date, and thereafter with respect to 1/48
th
of the total number of shares on each monthly anniversary of your start date. If, after a "change of control" transaction, as will be defined in your option agreement with the Company, you are terminated without Cause
l
or you terminate your employment for Good Reason
2
, then vesting will accelerate with respect to 100% of the remaining unvested shares
____________________________
l
For purposes of this paragraph, "Cause" means (i) your gross negligence or willful failure substantially to perform your duties and responsibilities to the Company or deliberate violation of a Company policy; (li) your commission of any act of fraud, embezzlement or dishonesty against the Company or any other willful misconduct that has caused or is reasonably expected to result in material injury to the Company; (iii) your unauthorized use or disclosure of any proprietary information or trade secrets of the Company or any other party to whom you owe an obligation of nondisclosure as a result of your relationship with the Company; or (iv) your willful breach of any of your obligations under any written agreement or covenant with the Company.
² For the purposes of this agreement, "Good Reason" means the occurrence at any time of any of the following without your prior written consent: (a) the material diminution in your authority, duties or responsibilities (other than a mere change in title following any merger or consolidation of the Company with another entity); (b) the assignment of duties or responsibilities materially inconsistent with those customarily associated with the position of Chief Medical Officer or a material diminution of your position, authority, duties or responsibilities (other than a mere change in title following any merger or consolidation of the Company with another entity); (c) a material reduction in your base salary; (d) any willful failure or willful breach by the Company of any of the material obligations of this Agreement; (e) a requirement that you relocate your principal place of business by more than fifty
(SO)
miles; or (f) a requirement that you travel more than 30% of the time. For purposes of this subsection, no act, or failure to act, on the Company's part shall be deemed "willful" unless done, or omitted to be done, by the Company not in good faith and without reasonable belief that the Company's act, or failure to act, was in the best interest of the Company. You may terminate your employment under this Agreement for Good Reason at any time on or prior to the 180th day after the initial occurrence of any of the foregoing Good Reason events; provided, however, that, within ninety (90) days of any such events having fU'St occurred, you shall have provided the Company with notice that such event(s) have occurred and afforded the Company thirty (30) days to cure same.
as of the date of termination. The option shall be subject to the terms and conditions of the Plan and the option agreement to be entered between you and the Company. The Company will also provide you the opportunity to exercise your option with respect to unvested shares, subject to a "reverse vesting" schedule for the Company to repurchase unvested shares at the option exercise price according to the schedule set forth above.
Benefits:
You will be eligible to participate in the benefits made generally available by the Company to its senior executives, in accordance with the benefit plans established by the Company, and as may be amended from time to time in the Company's sole discretion.
Full Time and Attention
: In this position you will dedicate your full business time and attention to the business of the Company. Except upon our prior written consent, you will not, during your employment with the Company, engage, directly or indirectly, in any other business activity (whether or not pursued for pecuniary advantage) that might interfere with your duties and responsibilities as a Company employee or create a conflict of interest with the Company.
At-Will Employment; Severance:
The Company is an "at-will" employer. Accordingly, either you or the Company may terminate the employment relationship at any time, with or without advance notice, and with or without cause. Upon any termination of your employment, you will be deemed to have resigned. In the event the Company terminates your employment without Cause, or you terminate your employment for Good Reason, you will be eligible to receive an amount equal to six (6) months of your base salary ("Severance Benefits"). Your eligibility for this Severance Benefits is conditioned upon your execution of a release of claims in a form provided by the Company (the "Release") within forty-five (45) days following your termination date and non-revocation of the Release during any applicable statutory revocation period. If you comply with these conditions, the Severance payments will commence on the sixtieth (60th) day following your termination date.
Taxes:
All amounts paid under this letter shall be paid less all applicable state and federal tax withholdings (if any) and any other withholdings required by any applicable jurisdiction or authorized by you. Notwithstanding any other provision of this letter whatsoever, the Company, in its sole discretion, shall have the right to provide for the application and effects of Section 409A of the Code (relating to deferred compensation arrangements) and any related administrative guidance issued by the Internal Revenue Service. The Company shall have the authority to delay the payment of any amounts under this Agreement to the extent it deems necessary or appropriate to comply with Section 409A(a)(2)(B)(i) of the Code (relating to payments made to certain "key employees" of publicly-traded companies); in such event, any such amount to which you would otherwise be entitled during the six (6) month period immediately following your termination of employment with the Company will be paid in a lump sum on the date six (6) months and one (1) day following the date of your termination of employment with the Company (or the next business day if such date is not a business day), provided that you have complied with the requirements for such payment. You shall be treated as having a termination of employment under this Agreement only if such termination meets the requirements of a "separation from service" as that term is defined in Section 409A(a)(2)(A)(i) of the Internal Revenue Code of 1986, as amended (the "Code") and Treas. Regs. Section 1.409A-l(h), and as amplified by any other official guidance. This Agreement is intended to comply with the provisions of Code Section 409A; provided, however, that the Company makes no representation that the amounts payable under this Agreement will comply with Code Section 409A and makes no undertaking to prevent Code Section 409A
from applying to amounts payable under this Agreement or to mitigate its effects on any deferrals or payments made under this Agreement.
In the event that the severance and other benefits provided for in this offer letter or otherwise payable to you (i) constitute "parachute payments" within the meaning of Section 2800 of the Code, and (ii) but for this paragraph would be subject to the excise tax imposed by Section 4999 of the Code (the "Excise Tax"), then your benefits under this offer letter shall be either (a) delivered in full, or (b) delivered as to such lesser extent which would result in no portion of such benefits being subject to the Excise Tax, whichever of the foregoing amounts, taking into account the applicable federal, state and local income taxes and the Excise Tax, results in the receipt by you on an after-tax basis, of the greatest amount of benefits, notwithstanding that all or some portion of such benefits may be taxable under Section 4999 of the Code.
Entire Agreement.
Please let us know of your decision to join the Company by signing a copy of this offer letter and returning it to us not later than January 15,2016. This letter sets forth our entire agreement and understanding regarding the terms of your employment with the Company and supersedes any prior representations or agreements, whether written or oral. This letter may not be modified in any way except in a writing signed by the Chief Executive Officer and you. It shall be governed by California law, without regard to principles of conflicts of laws. Your employment is contingent upon your execution of the Company's Proprietary Information and Invention Assignment Agreement.
We look forward to having you join us. We are planning for your first day at Tigercat to be January 25, 2016.
Sincerely,
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/s/
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Steven L. Basta
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Steven L. Basta
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CEO
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Tigercat Pharma
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ACCEPTED AND AGREED:
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/s/
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Paul Kwon, MD
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Paul Kwon, MD
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1/14/2016
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Date
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Exhibit 10.9
Kristine Ball
[***]
August 15, 2017
Dear Kristine:
I am pleased to extend to you an offer of employment with Menlo Therapeutics Inc. (the "Company"), in
the position of Chief Financial Officer and SVP Corporate Strategy.
Salary:
Your initial base salary will be $380,000 per year, less applicable withholdings. Your salary will be reviewed from time to time by the Board of Directors or its compensation committee, and may be adjusted in the sole discretion of the Board of Directors or its compensation committee.
Bonus:
The Company will establish, in cooperation with you, objectives for your activities annually. The Company will evaluate your achievement of those objectives annually and you will be eligible for an annual bonus of up to 30% of your base salary.
Equity Award:
After the start of your employment with the Company, the Board of Directors intends to grant you an option, in the amount of 467,000 shares, to purchase shares of Common Stock of the Company. The exercise price of such option will be the fair market value of the Company's Common Stock on the date of grant, as determined by the Board of Directors based on an independent valuation intended to satisfy the safe harbor requirements of Section 409A of the Internal Revenue Code. The options shall vest with respect to 25% of the total number of shares on the one-year anniversary of your start date, and thereafter with respect to 1/48th of the total number of shares on each monthly anniversary of your start date. If, after a "change of control" transaction, as will be defined in your option agreement with the Company,
you are terminated without Cause¹ or you terminate your employment for Good Reason², then
vesting will accelerate with respect to 100% of the remaining unvested shares as of the date of termination. Vesting will also accelerate automatically for the remaining unvested shares upon the 1-year anniversary following a “change of control” transaction, subject to your continued employment during that period. The option shall be subject to the terms and conditions of the Plan and the option agreement to be entered between you and the Company.
_________________________________
¹
For purposes of this paragraph, "Cause" means (i) your gross negligence or willful failure substantially to perform your duties and
responsibilities to the Company or deliberate violation of a Company policy;
your commission of any act of fraud, embezzlement or dishonesty against the Company or any other willful misconduct that has caused or is reasonably expected to result in material injury to the Company;
your unauthorized use or disclosure of any proprietary information or trade secrets of the Company or any other party to whom you owe an obligation of nondisclosure as a result of your relationship with the Company; or (iv) your willful breach of any of your obligations under any written agreement or covenant with the Company
²
For the purposes of this agreement, "Good Reason" means the occurrence at any time of any of the following without your prior
written consent: (a) the material diminution in your authority
,
duties or responsibilities (other than a mere change in title following any merger or consolidation of the Company with another entity)
;
(b) the assignment of duties or responsibilities materially inconsistent with those customarily associated with the position described in this offer letter or a material diminution of your position, authority, duties or responsibilities (other than a mere change in title following any merger or consolidation of the Company with another entity); (c) a material reduction in your base salary
;
(d) any willful failure or willful breach by the Company of any of the material obligations of this Agreement; or (e) a requirement that you relocate your principal place of business by more than fifty (50) miles
.
For purposes of this subsection, no act, or failure to act, on the Company's part shall be deemed "willful
"
unless done, or omitted to be done, by the Company not in good faith and without reasonable belief that the Company's act, or failure to act
,
was in the best interest of the Company
.
You may terminate your employment under this Agreement for Good Reason at any time on or prior to the 180th day after the initial occurrence of any of the foregoing Good Reason events; provided
,
however, that, within ninety (90) days of any such events having first
occurred, you shall have provided the Company with notice that such event(s) have occurred and afforded the Company thirty (30) days to cure same.
4085 Campbell Avenue • Suite 200 • Menlo Park, CA 94025
Full Time and Attention:
In this position you will dedicate your full business time and attention to the business of the Company. Except upon our prior written consent
,
you will not, during your employment with the Company, engage, directly or indirectly, in any other business activity (whether or not pursued for pecuniary advantage) that might interfere with your duties and responsibilities as a Company employee or create a conflict of interest with the Company. We acknowledge that you may for a limited period of time engage in certain activities associated with other consulting engagements previously committed by you to other parties. In order to fairly manage those, we will work with you to adjust your time (and pro-rata adjust compensation) for a reasonable period of time as may be requested by you to enable you to complete any such obligations
.
At-Will Employment; Severance:
The Company is an "at-will" employer. Accordingly, either you or the Company may terminate the employment relationship at any time, with or without advance notice, and with or without cause. Upon any termination of your employment, you will be deemed to have resigned. In the event the Company terminates your employment without Cause, or you terminate your employment for Good Reason, you will be eligible to receive an amount equal to six (6) months of your base salary ("Severance Benefits"). Your eligibility for this Severance Benefits is conditioned upon your execution of a release of claims in a form provided by the Company (the "Release") within forty-five (45) days following your termination date and non-revocation of the Release during any applicable statutory revocation period.
Taxes:
All amounts paid under this letter shall be paid less all applicable state and federal tax withholdings (if any) and any other withholdings required by any applicable jurisdiction or authorized by you. Notwithstanding any other provision of this letter whatsoever, the Company, in its sole discretion, shall have the right to provide for the application and effects of Section 409A of the Code (relating to deferred compensation arrangements) and any related administrative guidance issued by the Internal Revenue Service.
The Company shall have the authority to delay the payment of any amounts under this Agreement to the extent it deems necessary or appropriate to comply with Section 409A(a)(2)(B)(i) of the Code (relating to payments made to certain "key employees" of publicly-traded companies); in such event, any such amount to which you would otherwise be entitled during the six (6) month period immediately following your termination of employment with the Company will be paid in a lump sum on the date six (6) months and one (1) day following the date of your termination of employment with the Company (or the next business day if such date is not a business day), provided that you have complied with the requirements for such payment. You shall be treated as having a termination of employment under this Agreement only if such termination meets the requirements of a "separation from service" as that term is defined in Section 409A(a)(2)(A)(i) of the Internal Revenue Code of 1986, as amended (the "Code") and Treas. Regs. Section 1.409A-l(h), and as amplified by any other official guidance
.
This Agreement is intended to comply with the provisions of Code Section 409A; provided, however, that the Company makes no representation that the amounts payable under this Agreement will comply with Code Section 409A and makes no undertaking to prevent Code Section 409A from applying to amounts payable under this Agreement or to mitigate its effects on any deferrals or payments made under this Agreement.
In the event that the severance and other benefits provided for in this offer letter or otherwise payable to you (i) constitute "parachute payments" within the meaning of Section 280G of the Code, and (ii) but for this paragraph would be subject to the excise tax imposed by Section 4999 of the Code (the "Excise Tax"), then your benefits under this offer letter shall be either (a) delivered in full, or (b) delivered as to such lesser extent which would result in no portion of such benefits being subject to the Excise Tax, whichever of the foregoing amounts, taking into account the applicable federal, state and local income taxes and the Excise Tax, results in the
receipt by you on an after-tax basis, of the greatest amount of benefits, notwithstanding that all or some portion of such benefits may be taxable under Section 4999 of the Code
.
4085 Campbell Avenue • Suite 200 • Menlo Park, CA 94025
Entire Agreement:
Please let us know of your decision to join the Company by signing a copy of this offer letter and returning it to us not later than
August 18, 2017.
This letter sets forth our entire agreement and understanding regarding the terms of your employment with the Company and supersedes any prior representations or agreements, whether written or oral. This
letter may not be modified in any way except in a writing signed by the Chief Executive Officer and you. It shall be governed by California law, without regard to principles of conflicts of laws
.
Your employment is contingent upon your execution of the Company's Proprietary Information and Invention Assignment Agreement.
We look forward to having you join us
.
Sincerely,
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/s/
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Steven L. Basta
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Steven L. Basta
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Cheif Executive Officer
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Menlo Therapeutics
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ACCEPTED AND AGREED:
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/s/
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Kristine Ball
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Kristine Ball
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8/16/2017
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Date
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4085 Campbell Avenue • Suite 200 • Menlo Park, CA 94025
CONSULTING AGREEMENT
This CONSULTING AGREEMENT ("Agreement"), made as of March 8, 2016, ("the Effective Date") is entered into by Tigercat Pharma, Inc, ("Company"), and David Collier, an individual ("Consultant").
INTRODUCTION
The Company receives services from Velocity Pharmaceutical Development, LLC ("VPD"), and Consultant is a partner, associate or employee of VPD. The Company desires to grant Consultant compensation in the form of options to purchase Common Stock of the Company in consideration for the Services specifically provided by Consultant, whether or not Consultant remains associated with VPD. Nothing in this Consulting Agreement is intended to alter or modify any agreement that the Company has with VPD. For good and valuable consideration, the receipt and sufficiency of which is acknowledged, the parties agree as follows:
1.
Services.
(a)
Consultant agrees to provide advisory and support services to the Company as described in Exhibit A.
(b)
Consultant will comply with all policies, rules and regulations adopted by the Company and made known to the Consultant in writing.
2.
Term.
(a)
This Agreement shall commence on the Effective Date and shall continue for four years, unless amended by mutual written consent of the Company and the Consultant or sooner terminated as provided below (the "Term").
(b)
The Consultant may terminate this Agreement at any time, effective upon 5 days prior written notice. The Company may terminate this Agreement only by written notice based on a material breach by Consultant, including failure to provide Services.
(c)
The provisions of Sections 4, 5, 7 and 8 of this Agreement shall survive the expiration or termination of this Agreement.
3.
Compensation.
(a)
The consideration for the Services is set forth on Exhibit A. The Stock Option grant provided in connection with this Agreement as set forth in Exhibit A shall be the only compensation due directly to Consultant from the Company pursuant to this Agreement. No cash or other compensation shall be due to the Consultant under this Agreement. Promptly after execution of this Agreement, Consultant shall deliver to Company a properly completed and duly executed Department of the Treasury IRS Form W-9 or, if Consultant is a non-U.S. person, a Department of the Treasury IRS Form W-8BEN (or other appropriate Form W-8).
4.
Confidentiality and Non-Competition.
(a)
Consultant acknowledges that his relationship with the Company is one of high trust and confidence and that in the course of his service to the Company he will have access to and contact with confidential and proprietary information of the Company and its affiliates. Consultant agrees that he will not,
during the Term or at any time thereafter, disclose to others, or use for his benefit or the benefit of others, any Proprietary Information or Inventions (as defined below). "Proprietary Information" means any and all information and materials, in whatever form, tangible or intangible, whether disclosed to or learned or developed by Consultant before or after the execution of this Agreement, whether or not marked or identified as confidential or proprietary, pertaining in any manner to the Business of or used by the Company and its affiliates, or pertaining in any manner to any person or entity to whom the Company owes a duty of confidentiality. For the purposes of this Section 4, the Company's "affiliates" means any entity of which the Company owns 50% or more of the voting securities. Proprietary Information includes, but is not limited to, the following types of information and materials about the Company: (i) research, development or technical information, know-how, pre-clinical data, clinical data, compounds, formulations, plans, projects, documents, files, results, specifications, trade secrets, inventions, discoveries, compositions, ideas, concepts, structures, improvements, products, prototypes, works in process, systems, regulatory information, disclosures, applications and other materials; (ii) financial information and materials, including, without limitation, information and materials relating to costs, vendors, suppliers, licensors, profits, markets, sales, distributors, joint venture partners, customers, subscribers, members and bids, whether existing or potential; (iii) business and marketing information and materials, including, without limitation, information and materials relating to future development and new product concepts; (iv) personnel files and information about compensation, benefits and other terms of employment of the Company's other employees and independent contractors; and (v) any other information or materials relating to Business, whether in the past, present, or planned or foreseeable future. Consultant understands that Proprietary Information includes, but is not limited to, information pertaining to any aspect of the Business which is either information not known by actual or potential competitors of the Company or other third parties not under confidentiality obligations to the Company, or is otherwise proprietary information of the Company or its customers or suppliers, whether of a technical nature or otherwise. Consultant further understands that Proprietary Information does not include any of the foregoing items which (i) has become publicly and widely known and made generally available through no wrongful act of Consultant or of others who were under confidentiality obligations as to the item or items involved, or (ii) was in Consultant's possession prior to Consultant's engagement with the Company, either directly, through VPD or otherwise.
(b)
Upon termination of this Agreement or at any other time upon request by the Company, the Consultant shall promptly deliver to the Company all documents and materials embodying Proprietary Information.
(c)
Consultant represents that his retention as a Consultant with the Company, and his performance under this Agreement does not, and will not, breach any agreement to which the Consultant is a party or any policy by which the Consultant is bound. Consultant shall not
disclose to the Company any trade secrets or confidential or proprietary information of any other party.
(d)
During the term of this agreement, Consultant agrees that s/he shall not be employed by, provide consulting services to, or otherwise advise or assist a third party in developing a therapy intended to treat pruritus, that uses an NK 1 antagonist, that is directed at an indication under active development by the Company during the term of this Agreement, or that relates to a specific program evaluated by Consultant directly at the request of the Company or by VPD under the Development Services Agreement between the Company and VPD (the "Business").
(e)
The Company acknowledges that 18 U.S.C. § 1833(b) states: "An individual shall not be held criminally or civilly liable under any Federal or State trade secret law for the disclosure of a trade secret that-(A) is made-(i) in confidence to a Federal, State, or local government official, either directly or indirectly, or to an attorney; and (ii) solely for the purpose of reporting or investigating a suspected violation of law; or
(B) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal." Accordingly, Consultant shall have the right to disclose in confidence trade secrets to Federal, State, and local government officials, or to an attorney, for the sole purpose of reporting or investigating a suspected violation of law. Consultantant shall also have the right to disclose trade secrets in a document filed in a lawsuit or other proceeding, but only if the filing is made under seal and protected from public disclosure. Nothing in this Agreement is intended to conflict with 18 U.S.C. § 1833(b) or create liability for disclosures of trade secrets that are expressly allowed by 18 U.S.C. § 1833(b).
5.
Inventions.
(a)
All inventions, discoveries, data, technology, designs, innovations and improvements (whether or not patentable and whether or not copyrightable) related to the Business, which are made, conceived, written, designed or developed by the Consultant in the course of the performance of services hereunder, solely or jointly with others, and whether during normal business hours or otherwise ("Inventions"), shall be the sole property of the Company. Consultant agrees to assign and hereby assigns to the Company all Inventions and any and all related patents, copyrights, trademarks, trade names, and other industrial and intellectual property rights and applications therefor, in the United States and elsewhere, and appoints any officer of the Company as his duly authorized attorney to execute, file, prosecute and protect the same before any government agency, court or authority. Consultant hereby waives all claims to moral rights in all Inventions. Upon the request of the Company and at the Company's expense, the Consultant shall execute such further assignments, documents and other instruments as may be necessary or desirable to fully and completely assign all Inventions to the Company and to assist the Company in applying for, obtaining and enforcing patents or copyrights or other rights in the United States and in any foreign country with respect to any Invention.
(b)
Consultant agrees that, if the Company is unable because of Consultant's unavailability, dissolution, mental or physical incapacity, or for any other reason, to secure Consultant's signature for the purpose of applying for or pursuing any application for any United States or foreign patents or mask work or copyright registrations covering the Inventions assigned
to the Company in Section 5(a), then Consultant hereby irrevocably designates and appoints the Company and its duly authorized officers and agents as Consultant's agent and attorney-in-fact, to act for and on Consultant's behalf to execute and file any such applications and to do all other lawfully permitted acts to further the prosecution and issuance of patents, copyright and mask work registrations with the same legal force and effect as if executed by Consultant.
(c)
Consultant shall promptly disclose to the Company all Inventions and will maintain adequate and current written records (in the form of notes, sketches, drawings or in such form as may be specified by the Company) to document the conception and/or first actual reduction to practice of any Invention. Such written records shall be available to and remain the sole property of the Company at all times.
6.
Independent Contractor Status.
(a)
Consultant shall perform all services under this Agreement as an "independent contractor" and not as an employee or agent of the Company.
(b)
Consultant is responsible for all taxes (federal, state and local) due with respect to the compensation paid or payable pursuant to this Agreement and shall indemnify and hold the Company and its officers and directors harmless from and against all such liabilities.
(c)
Consultant is not authorized to create any liability, obligation or responsibility, express or implied, on behalf of, or in the name of, the Company or to bind the Company in any manner.
7.
Nonsolicitation and Other A
greements.
From the date of this Agreement until 12 months after the termination of this Agreement (the "Restricted Period"), Consultant will not, without the Company's prior written consent, directly or indirectly, solicit or encourage any employee or contractor of the Company to terminate employment with, or cease providing services to, the Company. During the Restricted Period, Consultant will not, whether for Consultant's own account or for the account of any other person, firm, corporation or other business organization, intentionally interfere with the relationship between the Company and any person who is or during the period of Consultant's engagement by the Company was a partner, supplier, customer or client of the Company or its affiliates. During the Term and thereafter, Consultant will not make derogatory or disparaging statements, either written or oral or otherwise, regarding the Company or its products or services, or their officers, directors, agents, employees and service providers.
8.
Miscellaneous.
(a)
All demands, notices, requests, consents and other communications required or permitted under this Agreement shall be in writing and shall be personally delivered or sent by facsimile machine or electronic mail (with a confirmation copy sent by one of the other methods authorized in this Section 8(a)), reputable commercial overnight delivery service (including Federal Express and U.S. Postal Service overnight delivery service) or, deposited with the U.S. Postal Service mailed first class, as set forth below:
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If to the Consultant:
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[***]
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If to the Company:
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Tigercat Pharma, Inc
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Attn: Chief Executive Officer
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[***]
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(b)
This agreement: (i) may be executed in any number of counterparts, each of which, when executed by both parties to this agreement shall be deemed to be an original, and all of which counterparts together shall constitute one and the same instrument; (ii) shall be governed by and construed under the laws of the State of California without regard to California conflicts of law rules.
(c)
Consultant acknowledges and agrees that the agreements and restrictions contained in Sections 4, and 5 are necessary for the protection of the business and goodwill of the Company and are reasonable for such purpose. Consultant acknowledges and agrees that any breach of the provisions of Sections 4 and 5 may cause the Company substantial and irreparable damage for which the Company cannot be adequately compensated by monetary damages alone, and, therefore, in the event of any such breach, in addition to such other remedies which may be available, the Company shall have the right to seek specific performance and injunctive relief without the necessity of proving actual damages.
(d)
Consultant may not sell, assign or delegate any rights or obligations under this Agreement. The Company may assign this Agreement to (i) a Company affiliate or (ii) in the event of a merger, acquisition or sale of all or substantially all of the assets of the Company. Subject to the foregoing, this Agreement will be binding upon and inure to the benefit of the parties hereto, their successors and assigns.
(e)
Waiver of any provision of this Agreement, in whole or in part, in any one instance shall not constitute a waiver of any other provision in the same instance, nor any waiver of the same provision in another instance, but each provision shall continue in full force and effect with respect to any other then-existing or subsequent breach.
(f)
This Agreement constitutes the entire agreement of the parties with respect to its subject matter, superseding all prior oral and written communications, proposals, negotiations, representations, understandings, courses of dealing, agreements, contracts, and the like between the parties in such respect. This Agreement may be amended or waived only upon written consent of the Consultant and the Company.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year set forth above.
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Tigercat Pharma, Inc.
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By:
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/s/ Steven L. Basta
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Name: Steven L. Basta
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Title: Cheif Executive Officer
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Consultant
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By:
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/s/ David Collier
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Name: David Collier
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Exhibit A
Services
The intent of this agreement is for Consultant to provide good faith support and positive contributions to the Company during the term of this agrement. In addition to any Services provided under the separate VPD Development Services Agreement, Consultant shall during the term of this agreement:
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–
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Be available and promptly responsive to questions and inquiries by Company staff regarding NKl antagonist science, or serlopitant in particular, including the past clinical studies, preclinical data, IP filings, Merck data and history, and competitive intelligence regarding pruritus programs
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–
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Provide support as reasonably requested to facilitate transfer of any past knowledge or materials or to assist with patent filings, execution of legal documents related to IP, or other matters as reasonably requested related to Serlopitant and Tigercat activities Support and facilitate discussions with 3rd parties including communicating with any parties to provide context and introductions as requested, particularly with respect to companies with whom VPD had discussed previously the Company program
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–
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Facilitate and promote the Company's success generally through positive interactions, introductions and other communications with investors, potential partners for serlopitant, or other technology partners with whom the Company may interact
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–
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Provide introductions and communications as requested to clinical, regulatory, or scientific advisors, or to consultants, investigators,
vendors,
potential corporate partners, or others as may be requested by the Company
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–
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Provide guidance, advice or other support for clinical and regulatory strategies and study designs, or commercial planning or strategies as may be requested by the Company Provide such other reasonable support as may be requested by the Company.
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After the earlier of (a) December 31, 2016 or (b) the termination of the Services Agreement between the Company and Velocity Pharmaceutical Development LLC, Consultant shall not be obliged to provide Services of more than four (4) hours per month, provided that unused hours
shall carry-forward to subsequent months, up to a maximum of six (6) months (i.e., a maximum carry-forward of 24 hours).
Consideration
In connection with the effectiveness ofthis agreement, the consultant is receiving as consideration options to purchase 84,942 shares of common stock of the Company, such options to vest as follows:
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•
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50% of the Shares will vest monthly over four (4) years, starting on the Effective Date (i.e., at the rate of 1/96th of the total number of Shares on each monthly anniversary of the Effective Date), during the term of this Agreement
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•
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50% of the Shares will vest monthly during the term of this Agreement over twelve (12) months (i.e., at the rate of 1/24 of the total number of Shares per month), starting on the Effective Date of a definitive development and collaboration agreement between the Company and Torii Pharmaceutical Co. Ltd. providing for an exclusive license to Serlopitant in Japan (the "Torii Agreement"), so long as such license agreement is executed on or before December 31, 2016. For clarity, in the event the Torii Agreement is not executed on or before December 31, 2016, or if the Company is acquired prior to the execution of an agreement with Torii, the option will terminate with respect to those shares and no vesting of those shares will occur.
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The exercise price of the option will be the fair market value of the Company's Common Stock on the date of grant, and the option will be subject to the terms of the Plan and the option agreement between you and the Company.
INDEMNIFICATION AGREEMENT
THIS INDEMNIFICATION AGREEMENT (the “
Agreement
”) is made and entered into as of _________, 20__, by and between Menlo Therapeutics Inc., a Delaware corporation (the “
Company
”), and _________ (“
Indemnitee
”).
WITNESSETH THAT:
WHEREAS, highly competent persons have become more reluctant to serve corporations as directors or in other capacities unless they are provided with adequate protection through insurance or adequate indemnification against inordinate risks of claims and actions against them arising out of their service to and activities on behalf of the corporation;
WHEREAS, the Board of Directors of the Company (the “
Board
”) has determined that, in order to attract and retain qualified individuals, the Company will attempt to maintain on an ongoing basis, at its sole expense, liability insurance to protect persons serving the Company and its subsidiaries from certain liabilities. Although the furnishing of such insurance has been a customary and widespread practice among United States-based corporations and other business enterprises, the Company believes that, given current market conditions and trends, such insurance may be available to it in the future only at higher premiums and with more exclusions. At the same time, directors, officers, and other persons in service to corporations or business enterprises are being increasingly subjected to expensive and time-consuming litigation relating to, among other things, matters that traditionally would have been brought only against the Company or business enterprise itself. The Bylaws of the Company require indemnification of the officers and directors of the Company. Indemnitee may also be entitled to indemnification pursuant to the General Corporation Law of the State of Delaware (the “
DGCL
”). The Bylaws and the DGCL expressly provide that the indemnification provisions set forth therein are not exclusive, and thereby contemplate that contracts may be entered into between the Company and members of the Board, officers and other persons with respect to indemnification;
WHEREAS, the uncertainties relating to such insurance and to indemnification have increased the difficulty of attracting and retaining such persons;
WHEREAS, the Board has determined that the increased difficulty in attracting and retaining such persons is detrimental to the best interests of the Company's stockholders and that the Company should act to assure such persons that there will be increased certainty of such protection in the future;
WHEREAS, it is reasonable, prudent and necessary for the Company contractually to obligate itself to indemnify, and to advance expenses on behalf of, such persons to the fullest extent permitted by applicable law so that they will serve or continue to serve the Company free from undue concern that they will not be so indemnified;
WHEREAS, this Agreement is a supplement to and in furtherance of the Bylaws and Certificate of Incorporation of the Company and any resolutions adopted pursuant thereto, and shall not be deemed a substitute therefor, nor to diminish or abrogate any rights of Indemnitee thereunder;
WHEREAS, Indemnitee does not regard the protection available under the Company's
Bylaws and Certificate of Incorporation and insurance as adequate in the present circumstances, and may not be willing to serve as an officer or director without adequate protection, and the Company desires Indemnitee to serve in such capacity. Indemnitee is willing to serve, continue to serve and to take on additional service for or on behalf of the Company on the condition that he be so indemnified; and
WHEREAS, Indemnitee may have certain rights to indemnification and/or insurance provided by other entities and/or organizations, including _________ and/or any direct or indirect subsidiary or affiliate thereof (collectively, the “
Fund Indemnitors
”) which Indemnitee and such Fund Indemnitors intend to be secondary to the primary obligation of the Company to indemnify Indemnitee as provided herein, with the Company’s acknowledgement and agreement to the foregoing being a material condition to Indemnitee’s willingness to serve on the Board.
NOW, THEREFORE, in consideration of Indemnitee’s agreement to serve as a director after the date hereof, the parties hereto agree as follows:
1.
Indemnity of Indemnitee
. The Company hereby agrees to hold harmless and indemnify Indemnitee to the fullest extent permitted by law, as such may be amended from time to time. In furtherance of the foregoing indemnification, and without limiting the generality thereof:
(a)
Proceedings Other Than Proceedings by or in the Right of the Company
. Indemnitee shall be entitled to the rights of indemnification provided in this
Section l(a)
if, by reason of his Corporate Status (as hereinafter defined), the Indemnitee is, or is threatened to be made, a party to or participant in any Proceeding (as hereinafter defined) other than a Proceeding by or in the right of the Company. Pursuant to this
Section 1(a)
, Indemnitee shall be indemnified against all Expenses (as hereinafter defined), judgments, penalties, fines and amounts paid in settlement actually and reasonably incurred by him, or on his behalf, in connection with such Proceeding or any claim, issue or matter therein, 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 the Indemnitee’s conduct was unlawful.
(b)
Proceedings by or in the Right of the Company
. Indemnitee shall be entitled to the rights of indemnification provided in this
Section 1(b)
if, by reason of his Corporate Status, the Indemnitee is, or is threatened to be made, a party to or participant in any Proceeding brought by or in the right of the Company. Pursuant to this
Section 1(b)
, Indemnitee shall be indemnified against all Expenses actually and reasonably incurred by the Indemnitee, or on the Indemnitee’s behalf, 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, if applicable law so provides, no indemnification against such Expenses shall be made in respect of any claim, issue or matter in such Proceeding as to which Indemnitee shall have been adjudged to be liable to the Company unless and to the extent that the Court of Chancery of the State of Delaware shall determine that such indemnification may be made.
(c)
Indemnification for Expenses of a Party Who is Wholly or Partly Successful
. Notwithstanding any other provision of this Agreement, to the extent that Indemnitee is, by reason of his Corporate Status, a party to and is successful, on the merits or otherwise, in any
Proceeding, he shall be indemnified to the maximum extent permitted by law, as such may be amended from time to time, against all Expenses actually and reasonably incurred by him or on his behalf in connection therewith. If Indemnitee is not wholly successful in such Proceeding but is successful, on the merits or otherwise, as to one or more but less than all claims, issues or matters in such Proceeding, the Company shall indemnify Indemnitee against all Expenses actually and reasonably incurred by him or on his behalf in connection with each successfully resolved claim, issue or matter. For purposes of this Section and without limitation, the termination of any claim, issue or matter in such a Proceeding by dismissal, with or without prejudice, shall be deemed to be a successful result as to such claim, issue or matter.
2.
Additional Indemnity
. In addition to, and without regard to any limitations on, the indemnification provided for in
Section 1
of this Agreement, the Company shall and hereby does indemnify and hold harmless Indemnitee against all Expenses, judgments, penalties, fines and amounts paid in settlement actually and reasonably incurred by him or on his behalf if, by reason of his Corporate Status, he is, or is threatened to be made, a party to or participant in any Proceeding (including a Proceeding by or in the right of the Company), including, without limitation, all liability arising out of the negligence or active or passive wrongdoing of Indemnitee. The only limitation that shall exist upon the Company’s obligations pursuant to this Agreement shall be that the Company shall not be obligated to make any payment to Indemnitee that is finally determined (under the procedures, and subject to the presumptions, set forth in
Sections 6
and
7
hereof) to be unlawful.
3.
Contribution
.
(a)
Whether or not the indemnification provided in
Sections 1
and
2
hereof is available, in respect of any threatened, pending or completed action, suit or proceeding in which the Company is jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding), the Company shall pay, in the first instance, the entire amount of any judgment or settlement of such action, suit or proceeding without requiring Indemnitee to contribute to such payment and the Company hereby waives and relinquishes any right of contribution it may have against Indemnitee. The Company shall not enter into any settlement of any action, suit or proceeding in which the Company is jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding) unless such settlement provides for a full and final release of all claims asserted against Indemnitee.
(b)
Without diminishing or impairing the obligations of the Company set forth in the preceding subparagraph, if, for any reason, Indemnitee shall elect or be required to pay all or any portion of any judgment or settlement in any threatened, pending or completed action, suit or proceeding in which the Company is jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding), the Company shall contribute to the amount of Expenses, judgments, fines and amounts paid in settlement actually and reasonably incurred and paid or payable by Indemnitee in proportion to the relative benefits received by the Company and all officers, directors or employees of the Company, other than Indemnitee, who are jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding), on the one hand, and Indemnitee, on the other hand, from the transaction from which such action, suit or proceeding arose; provided, however, that the proportion determined on the basis of relative benefit may, to the extent necessary to conform to law, be further adjusted by reference to the relative fault of the Company and all officers, directors or employees of the Company other than Indemnitee who are
jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding), on the one hand, and Indemnitee, on the other hand, in connection with the events that resulted in such expenses, judgments, fines or settlement amounts, as well as any other equitable considerations which the Law may require to be considered. The relative fault of the Company and all officers, directors or employees of the Company, other than Indemnitee, who are jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding), on the one hand, and Indemnitee, on the other hand, shall be determined by reference to, among other things, the degree to which their actions were motivated by intent to gain personal profit or advantage, the degree to which their liability is primary or secondary and the degree to which their conduct is active or passive.
(c)
The Company hereby agrees to fully indemnify and hold Indemnitee harmless from any claims of contribution which may be brought by officers, directors or employees of the Company, other than Indemnitee, who may be jointly liable with Indemnitee.
(d)
To the fullest extent permissible under applicable law, if the indemnification provided for in this Agreement is unavailable to Indemnitee for any reason whatsoever, the Company, in lieu of indemnifying Indemnitee, shall contribute to the amount incurred by Indemnitee, whether for judgments, fines, penalties, excise taxes, amounts paid or to be paid in settlement and/or for Expenses, in connection with any claim relating to an indemnifiable event under this Agreement, in such proportion as is deemed fair and reasonable in light of all of the circumstances of such Proceeding in order to reflect (i) the relative benefits received by the Company and Indemnitee as a result of the event(s) and/or transaction(s) giving cause to such Proceeding; and/or (ii) the relative fault of the Company (and its directors, officers, employees and agents) and Indemnitee in connection with such event(s) and/or transaction(s).
4.
Indemnification for Expenses of a Witness
. Notwithstanding any other provision of this Agreement, to the extent that Indemnitee is, by reason of his Corporate Status, a witness in any Proceeding to which Indemnitee is not a party, he shall be indemnified against all Expenses actually and reasonably incurred by him or on his behalf in connection therewith.
5.
Advancement of Expenses
. Notwithstanding any other provision of this Agreement, the Company shall advance all Expenses incurred by or on behalf of Indemnitee in connection with any Proceeding by reason of Indemnitee’s Corporate Status within thirty (30) days after the receipt by the Company of a statement or statements from Indemnitee requesting such advance or advances from time to time, whether prior to or after final disposition of such Proceeding. Such statement or statements shall reasonably evidence the Expenses incurred by Indemnitee and shall include or be preceded or accompanied by an undertaking by or on behalf of Indemnitee to repay any Expenses advanced if it shall ultimately be determined that Indemnitee is not entitled to be indemnified against such Expenses. Any advances and undertakings to repay pursuant to this
Section 5
shall be (i) unsecured and interest free, (ii) shall be made without regard to the Indemnitee’s ability to repay the advances and without regard to the Indemnitee’s ultimate entitlement to indemnification under the other provisions of this Agreement, and (iii) shall include any and all reasonable Expenses incurred pursuing an action to enforce this right of advancement, including Expenses incurred preparing and forwarding statements to the Company to support the advances claimed. The Indemnitee shall qualify for advancement of Expenses solely upon the execution and delivery to the Company of an unsecured undertaking providing that the Indemnitee undertakes to
repay the advance to the extent and only to the extent that it is ultimately determined that the Indemnitee is not entitled to be indemnified by the Company.
6.
Procedures and Presumptions for Determination of Entitlement to Indemnification
. It is the intent of this Agreement to secure for Indemnitee rights of indemnity that are as favorable as may be permitted under the DGCL and public policy of the State of Delaware. Accordingly, the parties agree that the following procedures and presumptions shall apply in the event of any question as to whether Indemnitee is entitled to indemnification under this Agreement:
(a)
To obtain indemnification under this Agreement, Indemnitee shall submit to the Company a written request, including therein or therewith such documentation and information as is reasonably available to Indemnitee and is reasonably necessary to determine whether and to what extent Indemnitee is entitled to indemnification. The Secretary of the Company shall, promptly upon receipt of such a request for indemnification, advise the Board in writing that Indemnitee has requested indemnification.
(b)
Upon written request by Indemnitee for indemnification pursuant to the first sentence of
Section 6(a)
hereof, a determination, if required by applicable law, with respect to Indemnitee’s entitlement thereto shall be made either: (1) by a majority vote of the Disinterested Directors, even though less than a quorum, or by a committee of Disinterested Directors designated by a majority vote of the Disinterested Directors, even though less than a quorum, so long as the Indemnitee does not request that such determination be made by independent legal counsel, or (2) at the request of Indemnitee, in his sole discretion, by independent legal counsel in a written opinion to the Board, a copy of which shall be delivered to the Indemnitee.
(c)
If the determination of entitlement to indemnification is to be made by Independent Counsel pursuant to
Section 6(b)
hereof, the Independent Counsel shall be selected as provided in this
Section 6(c)
. The Independent Counsel shall be selected by the Board. Indemnitee may, within 10 days after such written notice of selection shall have been given, deliver to the Company, as the case may be, a written objection to such selection; provided, however, that such objection may be asserted only on the ground that the Independent Counsel so selected does not meet the requirements of “
Independent Counsel
” as defined in
Section 13
of this Agreement, and the objection shall set forth with particularity the factual basis of such assertion. Absent a proper and timely objection, the person so selected shall act as Independent Counsel. If a written objection is made and substantiated, the Independent Counsel selected may not serve as Independent Counsel unless and until such objection is withdrawn or a court has determined that such objection is without merit. If, within 20 days after submission by Indemnitee of a written request for indemnification pursuant to
Section 6(a)
hereof, no Independent Counsel shall have been selected and not objected to, either the Company or Indemnitee may petition the Court of Chancery of the State of Delaware or other court of competent jurisdiction for resolution of any objection which shall have been made by the Indemnitee to the Company’s selection of Independent Counsel and/or for the appointment as Independent Counsel of a person selected by the court or by such other person as the court shall designate, and the person with respect to whom all objections are so resolved or the person so appointed shall act as Independent Counsel under
Section 6(b)
hereof. The Company shall pay any and all reasonable fees and expenses of Independent Counsel incurred by such Independent Counsel in connection with acting pursuant to
Section 6(b)
hereof, and the Company shall pay all reasonable
fees and expenses incident to the procedures of this
Section 6(c)
, regardless of the manner in which such Independent Counsel was selected or appointed.
(d)
In making a determination with respect to entitlement to indemnification hereunder, the person or persons or entity making such determination shall presume that Indemnitee is entitled to indemnification under this Agreement. Anyone seeking to overcome this presumption shall have the burden of proof and the burden of persuasion by clear and convincing evidence. Neither the failure of the Company (including by its directors or independent legal counsel) to have made a determination prior to the commencement of any action pursuant to this Agreement that indemnification is proper in the circumstances because Indemnitee has met the applicable standard of conduct, nor an actual determination by the Company (including by its directors or independent legal counsel) that Indemnitee has not met such applicable standard of conduct, shall be a defense to the action or create a presumption that Indemnitee has not met the applicable standard of conduct.
(e)
Indemnitee shall be deemed to have acted in good faith if Indemnitee’s action is based on the records or books of account of the Enterprise, including financial statements, or on information supplied to Indemnitee by the officers of the Enterprise (as hereinafter defined) in the course of their duties, or on the advice of legal counsel for the Enterprise or on information or records given or reports made to the Enterprise by an independent certified public accountant or by an appraiser or other expert selected with reasonable care by the Enterprise. In addition, the knowledge and/or actions, or failure to act, of any director, officer, agent or employee of the Enterprise shall not be imputed to Indemnitee for purposes of determining the right to indemnification under this Agreement. Whether or not the foregoing provisions of this
Section 6(e)
are satisfied, it shall in any event be presumed that Indemnitee has at all times acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the Company. Anyone seeking to overcome this presumption shall have the burden of proof and the burden of persuasion by clear and convincing evidence.
(f)
If the person, persons or entity empowered or selected under
Section 6
to determine whether Indemnitee is entitled to indemnification shall not have made a determination within sixty (60) days after receipt by the Company of the request therefor, the requisite determination of entitlement to indemnification shall be deemed to have been made and Indemnitee shall be entitled to such indemnification absent (i) a misstatement by Indemnitee of a material fact, or an omission of a material fact necessary to make Indemnitee’s statement not materially misleading, in connection with the request for indemnification, or (ii) a prohibition of such indemnification under applicable law; provided, however, that such 60-day period may be extended for a reasonable time, not to exceed an additional thirty (30) days, if the person, persons or entity making such determination with respect to entitlement to indemnification in good faith requires such additional time to obtain or evaluate documentation and/or information relating thereto; and provided, further, that the foregoing provisions of this
Section 6(g)
shall not apply if the determination of entitlement to indemnification is to be made by the stockholders pursuant to
Section 6(b)
of this Agreement and if (A) within fifteen (15) days after receipt by the Company of the request for such determination, the Board or the Disinterested Directors, if appropriate, resolve to submit such determination to the stockholders for their consideration at an annual meeting thereof to be held within seventy-five (75) days after such receipt and such determination is made thereat, or (B) a special meeting of stockholders is called within fifteen (15) days after such receipt for the purpose of making such
determination, such meeting is held for such purpose within sixty (60) days after having been so called and such determination is made thereat.
(g)
Indemnitee shall cooperate with the person, persons or entity making such determination with respect to Indemnitee’s entitlement to indemnification, including providing to such person, persons or entity upon reasonable advance request any documentation or information which is not privileged or otherwise protected from disclosure and which is reasonably available to Indemnitee and reasonably necessary to such determination. Any Independent Counsel, member of the Board or stockholder of the Company shall act reasonably and in good faith in making a determination regarding the Indemnitee’s entitlement to indemnification under this Agreement. Any costs or expenses (including attorneys’ fees and disbursements) incurred by Indemnitee in so cooperating with the person, persons or entity making such determination shall be borne by the Company (irrespective of the determination as to Indemnitee’s entitlement to indemnification) and the Company hereby indemnifies and agrees to hold Indemnitee harmless therefrom.
(h)
The Company acknowledges that a settlement or other disposition short of final judgment may be successful if it permits a party to avoid expense, delay, distraction, disruption and uncertainty. In the event that any action, claim or proceeding to which Indemnitee is a party is resolved in any manner other than by adverse judgment against Indemnitee (including, without limitation, settlement of such action, claim or proceeding with or without payment of money or other consideration) it shall be presumed that Indemnitee has been successful on the merits or otherwise in such action, suit or proceeding. Anyone seeking to overcome this presumption shall have the burden of proof and the burden of persuasion by clear and convincing evidence.
(i)
The termination of any Proceeding or of any claim, issue or matter therein, by judgment, order, settlement or conviction, or upon a plea of nolo contendere or its equivalent, shall not (except as otherwise expressly provided in this Agreement) of itself adversely affect the right of Indemnitee to indemnification or create a presumption that Indemnitee did not act in good faith and in a manner which he reasonably believed to be in or not opposed to the best interests of the Company or, with respect to any criminal Proceeding, that Indemnitee had reasonable cause to believe that his conduct was unlawful.
7.
Remedies of Indemnitee
.
(a)
In the event that (i) a determination is made pursuant to
Section 6
of this Agreement that Indemnitee is not entitled to indemnification under this Agreement, (ii) advancement of Expenses is not timely made pursuant to
Section 5
of this Agreement, (iii) no determination of entitlement to indemnification is made pursuant to
Section 6(b)
of this Agreement within 90 days after receipt by the Company of the request for indemnification, (iv) payment of indemnification is not made pursuant to this Agreement within ten (10) days after receipt by the Company of a written request therefor or (v) payment of indemnification is not made within ten (10) days after a determination has been made that Indemnitee is entitled to indemnification or such determination is deemed to have been made pursuant to
Section 6
of this Agreement, Indemnitee shall be entitled to an adjudication in an appropriate court of the State of Delaware, or in any other court of competent jurisdiction, of Indemnitee’s entitlement to such indemnification. Indemnitee shall commence such proceeding seeking an adjudication within 180 days following the date on
which Indemnitee first has the right to commence such proceeding pursuant to this
Section 7(a)
. The Company shall not oppose Indemnitee’s right to seek any such adjudication.
(b)
In the event that a determination shall have been made pursuant to
Section 6(b)
of this Agreement that Indemnitee is not entitled to indemnification, any judicial proceeding commenced pursuant to this
Section 7
shall be conducted in all respects as a de novo trial on the merits, and Indemnitee shall not be prejudiced by reason of the adverse determination under
Section 6(b)
.
(c)
If a determination shall have been made pursuant to
Section 6(b)
of this Agreement that Indemnitee is entitled to indemnification, the Company shall be bound by such determination in any judicial proceeding commenced pursuant to this
Section 7
, absent (i) a misstatement by Indemnitee of a material fact, or an omission of a material fact necessary to make Indemnitee’s misstatement not materially misleading in connection with the application for indemnification, or (ii) a prohibition of such indemnification under applicable law.
(d)
In the event that Indemnitee, pursuant to this
Section 7
, seeks a judicial adjudication of his rights under, or to recover damages for breach of, this Agreement, or to recover under any directors’ and officers’ liability insurance policies maintained by the Company, the Company shall pay on his behalf, in advance, any and all expenses (of the types described in the definition of Expenses in
Section 13
of this Agreement) actually and reasonably incurred by him in such judicial adjudication, regardless of whether Indemnitee ultimately is determined to be entitled to such indemnification, advancement of expenses or insurance recovery.
(e)
The Company shall be precluded from asserting in any judicial proceeding commenced pursuant to this
Section 7
that the procedures and presumptions of this Agreement are not valid, binding and enforceable and shall stipulate in any such court that the Company is bound by all the provisions of this Agreement. The Company shall indemnify Indemnitee against any and all Expenses and, if requested by Indemnitee, shall (within ten (10) days after receipt by the Company of a written request therefore) advance, to the extent not prohibited by law, such expenses to Indemnitee, which are incurred by Indemnitee in connection with any action brought by Indemnitee for indemnification or advance of Expenses from the Company under this Agreement or under any directors' and officers' liability insurance policies maintained by the Company, regardless of whether Indemnitee ultimately is determined to be entitled to such indemnification, advancement of Expenses or insurance recovery, as the case may be.
(f)
Notwithstanding anything in this Agreement to the contrary, no determination as to entitlement to indemnification under this Agreement shall be required to be made prior to the final disposition of the Proceeding.
8.
Non-Exclusivity; Survival of Rights; Insurance; Primacy of Indemnification; Subrogation
.
(a)
The rights of indemnification as provided by this Agreement shall not be deemed exclusive of any other rights to which Indemnitee may at any time be entitled under applicable law, the certificate of incorporation of the Company, the Bylaws, any agreement, a vote of stockholders, a resolution of directors or otherwise. No amendment, alteration or repeal of this Agreement or of any provision hereof shall limit or restrict any right of Indemnitee under this
Agreement in respect of any action taken or omitted by such Indemnitee in his Corporate Status prior to such amendment, alteration or repeal. To the extent that a change in the DGCL, whether by statute or judicial decision, permits greater indemnification than would be afforded currently under the Bylaws and this Agreement, it is the intent of the parties hereto that Indemnitee shall enjoy by this Agreement the greater benefits so afforded by such change. No right or remedy herein conferred is intended to be exclusive of any other right or remedy, and every other right and remedy shall be cumulative and in addition to every other right and remedy given hereunder or now or hereafter existing at law or in equity or otherwise. The assertion or employment of any right or remedy hereunder, or otherwise, shall not prevent the concurrent assertion or employment of any other right or remedy.
(b)
To the extent that the Company maintains an insurance policy or policies providing liability insurance for directors, officers, employees, or agents or fiduciaries of the Company or of any other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise that such person serves at the request of the Company, Indemnitee shall be covered by such policy or policies in accordance with its or their terms to the maximum extent of the coverage available for any director, officer, employee, agent or fiduciary under such policy or policies. If, at the time of the receipt of a notice of a claim pursuant to the terms hereof, the Company has director and officer liability insurance in effect, the Company shall give prompt notice of the commencement of such proceeding to the insurers in accordance with the procedures set forth in the respective policies. The Company shall thereafter take all necessary or desirable action to cause such insurers to pay, on behalf of the Indemnitee, all amounts payable as a result of such proceeding in accordance with the terms of such policies.
(c)
The Company hereby acknowledges that Indemnitee may have certain rights to indemnification, advancement of expenses and/or insurance provided by the Fund Indemnitors. The Company hereby agrees (i) that it is the indemnitor of first resort (i.e., its obligations to Indemnitee are primary and any obligation of the Fund Indemnitors to advance expenses or to provide indemnification for the same expenses or liabilities incurred by Indemnitee are secondary), (ii) that it shall be required to advance the full amount of expenses incurred by Indemnitee and shall be liable for the full amount of all Expenses, judgments, penalties, fines and amounts paid in settlement to the extent legally permitted and as required by the terms of this Agreement and the Certificate of Incorporation or Bylaws of the Company (or any other agreement between the Company and Indemnitee), without regard to any rights Indemnitee may have against the Fund Indemnitors, and, (iii) that it irrevocably waives, relinquishes and releases the Fund Indemnitors from any and all claims against the Fund Indemnitors for contribution, subrogation or any other recovery of any kind in respect thereof. The Company further agrees that no advancement or payment by the Fund Indemnitors on behalf of Indemnitee with respect to any claim for which Indemnitee has sought indemnification from the Company shall affect the foregoing and the Fund Indemnitors shall have a right of contribution and/or be subrogated to the extent of such advancement or payment to all of the rights of recovery of Indemnitee against the Company. The Company and Indemnitee agree that the Fund Indemnitors are express third party beneficiaries of the terms of this Section 8(c).
(d)
Except as provided in paragraph (c) above, in the event of any payment under this Agreement, the Company shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee (other than against the Fund Indemnitors), who shall
execute all papers required and take all action necessary to secure such rights, including execution of such documents as are necessary to enable the Company to bring suit to enforce such rights.
(e)
Except as provided in paragraph (c) above, the Company shall not be liable under this Agreement to make any payment of amounts otherwise indemnifiable hereunder if and to the extent that Indemnitee has otherwise actually received such payment under any insurance policy, contract, agreement or otherwise.
(f)
Except as provided in paragraph (c) above, the Company's obligation to indemnify or advance Expenses hereunder to Indemnitee who is or was serving at the request of the Company as a director, officer, employee or agent of any other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise shall be reduced by any amount Indemnitee has actually received as indemnification or advancement of expenses from such other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise.
9.
Exception to Right of Indemnification
. Notwithstanding any provision in this Agreement, the Company shall not be obligated under this Agreement to make any indemnity in connection with any claim made against Indemnitee:
(a)
for which payment has actually been made to or on behalf of Indemnitee under any insurance policy or other indemnity provision, except with respect to any excess beyond the amount paid under any insurance policy or other indemnity provision, provided, that the foregoing shall not affect the rights of Indemnitee or the Fund Indemnitors set forth in Section 8(c) above; or
(b)
for an accounting of profits made from the purchase and sale (or sale and purchase) by Indemnitee of securities of the Company within the meaning of
Section 16(b)
of the Securities Exchange Act of 1934, as amended, or similar provisions of state statutory law or common law; or
(c)
in connection with any Proceeding (or any part of any Proceeding) initiated by Indemnitee, including any Proceeding (or any part of any Proceeding) initiated by Indemnitee against the Company or its directors, officers, employees or other indemnitees, unless (i) the Board authorized the Proceeding (or any part of any Proceeding) prior to its initiation or (ii) the Company provides the indemnification, in its sole discretion, pursuant to the powers vested in the Company under applicable law.
10.
Duration of Agreement
. All agreements and obligations of the Company contained herein shall continue during the period Indemnitee is an officer or director of the Company (or is or was serving at the request of the Company as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise) and shall continue thereafter so long as Indemnitee shall be subject to any Proceeding (or any proceeding commenced under
Section 7
hereof) by reason of his Corporate Status, whether or not he is acting or serving in any such capacity at the time any liability or expense is incurred for which indemnification can be provided under this Agreement. This Agreement shall be binding upon and inure to the benefit of and be enforceable by the parties hereto and their respective successors (including any direct or indirect successor by purchase, merger, consolidation or otherwise to all or substantially all of the
business or assets of the Company), assigns, spouses, heirs, executors and personal and legal representatives.
11.
Security
. To the extent requested by Indemnitee and approved by the Board, the Company may at any time and from time to time provide security to Indemnitee for the Company’s obligations hereunder through an irrevocable bank line of credit, funded trust or other collateral. Any such security, once provided to Indemnitee, may not be revoked or released without the prior written consent of the Indemnitee.
12.
Enforcement
.
(a)
The Company expressly confirms and agrees that it has entered into this Agreement and assumes the obligations imposed on it hereby in order to induce Indemnitee to serve as an officer or director of the Company, and the Company acknowledges that Indemnitee is relying upon this Agreement in serving as an officer or director of the Company.
(b)
This Agreement constitutes the entire agreement between the parties hereto with respect to the subject matter hereof and supersedes all prior agreements and understandings, oral, written and implied, between the parties hereto with respect to the subject matter hereof.
13.
Definitions
. For purposes of this Agreement:
(a)
“
Corporate Status
” describes the status of a person who is or was a director, officer, employee, agent or fiduciary of the Company or of any other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise that such person is or was serving at the express written request of the Company.
(b)
“
Disinterested Director
” means a director of the Company who is not and was not a party to the Proceeding in respect of which indemnification is sought by Indemnitee.
(c)
“
Enterprise
” shall mean the Company and any other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise that Indemnitee is or was serving at the express written request of the Company as a director, officer, employee, agent or fiduciary.
(d)
“
Expenses
” shall include all reasonable attorneys’ fees, retainers, court costs, transcript costs, fees of experts, witness fees, travel expenses, duplicating costs, printing and binding costs, telephone charges, postage, delivery service fees and all other disbursements or expenses of the types customarily incurred in connection with prosecuting, defending, preparing to prosecute or defend, investigating, participating, or being or preparing to be a witness in a Proceeding. Expenses also shall include Expenses incurred in connection with any appeal resulting from any Proceeding, including without limitation the premium, security for, and other costs relating to any cost bond, supersede as bond, or other appeal bond or its equivalent. Expenses, however, shall not include amounts paid in settlement by Indemnitee or the amount of judgments or fines against Indemnitee.
(e)
“
Independent Counsel
” means a law firm, or a member of a law firm, that is experienced in matters of corporation law and neither presently is, nor in the past five years has been, retained to represent: (i) the Company or Indemnitee in any matter material to either such party (other than with respect to matters concerning Indemnitee under this Agreement, or of other indemnitees under similar indemnification agreements), or (ii) any other party to the Proceeding giving rise to a claim 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 Indemnitee in an action to determine Indemnitee’s rights under this Agreement. The Company agrees to pay the reasonable fees of the Independent Counsel referred to above and to fully indemnify such counsel against any and all Expenses, claims, liabilities and damages arising out of or relating to this Agreement or its engagement pursuant hereto.
(f)
“
Proceeding
” includes any threatened, pending or completed action, suit, arbitration, alternate dispute resolution mechanism, investigation, inquiry, administrative hearing or any other actual, threatened or completed proceeding, whether brought by or in the right of the Company or otherwise and whether civil, criminal, administrative or investigative, in which Indemnitee was, is or will be involved as a party or otherwise, by reason of the fact that Indemnitee is or was an officer or director of the Company, by reason of any action taken by him or of any inaction on his part while acting as an officer or director of the Company, or by reason of the fact that he is or was serving at the request of the Company as a director, officer, employee, agent or fiduciary of another corporation, partnership, joint venture, trust or other Enterprise; in each case whether or not he is acting or serving in any such capacity at the time any liability or expense is incurred for which indemnification can be provided under this Agreement; including one pending on or before the date of this Agreement, but excluding one initiated by an Indemnitee pursuant to
Section 5
or
Section 7
of this Agreement to enforce his rights under this Agreement.
14.
Severability
. The invalidity or unenforceability of any provision hereof shall in no way affect the validity or enforceability of any other provision. Without limiting the generality of the foregoing, this Agreement is intended to confer upon Indemnitee indemnification rights to the fullest extent permitted by applicable laws. In the event any provision hereof conflicts with any applicable law, such provision shall be deemed modified, consistent with the aforementioned intent, to the extent necessary to resolve such conflict.
15.
Modification and Waiver
. No supplement, modification, termination or amendment of this Agreement shall be binding unless executed in writing by both of the parties hereto. No waiver of any of the provisions of this Agreement shall be deemed or shall constitute a waiver of any other provisions hereof (whether or not similar) nor shall such waiver constitute a continuing waiver.
16.
Notice By Indemnitee
. Indemnitee agrees promptly to notify the Company in writing upon being served with or otherwise receiving any summons, citation, subpoena, complaint, indictment, information or other document relating to any Proceeding or matter which may be subject to indemnification covered hereunder. The failure to so notify the Company shall not relieve the Company of any obligation which it may have to Indemnitee under this Agreement or otherwise unless and only to the extent that such failure or delay materially prejudices the Company.
17.
Notices
. All notices and other communications given or made pursuant to this Agreement shall be in writing and shall be deemed effectively given: (a) upon personal delivery to the party to be notified, (b) when sent by confirmed electronic mail or facsimile if sent during normal business hours of the recipient, and if not so confirmed, then on the next business day, (c) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one (1) day after deposit with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt. All communications shall be sent:
(a)
To Indemnitee at the address set forth below Indemnitee signature hereto.
(b)
To the Company at:
Menlo Therapeutics Inc.
4085 Campbell Avenue, Suite 200
Menlo Park, CA 94025
Attention: President
or to such other address as may have been furnished to Indemnitee by the Company or to the Company by Indemnitee, as the case may be.
18.
Counterparts
. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same Agreement. This Agreement may also be executed and delivered by facsimile signature and in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
19.
Headings
. The headings of the paragraphs 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.
20.
Governing Law and Consent to Jurisdiction.
This Agreement and the legal relations among the parties shall be governed by, and construed and enforced in accordance with, the laws of the State of Delaware, without regard to its conflict of laws rules. The Company and Indemnitee hereby irrevocably and unconditionally (i) agree that any action or proceeding arising out of or in connection with this Agreement shall be brought only in the Chancery Court of the State of Delaware (the “
Delaware Court
”), and not in any other state or federal court in the United States of America or any court in any other country, (ii) consent to submit to the exclusive jurisdiction of the Delaware Court for purposes of any action or proceeding arising out of or in connection with this Agreement, (iii) appoint, to the extent such party is not otherwise subject to service of process in the State of Delaware, The Corporation Trust Company, Wilmington, Delaware as its agent in the State of Delaware as such party's agent for acceptance of legal process in connection with any such action or proceeding against such party with the same legal force and validity as if served upon such party personally within the State of Delaware, (iv) waive any objection to the laying of venue of any such action or proceeding in the Delaware Court, and (v) waive, and agree not to plead or to make, any claim that any such action or proceeding brought in the Delaware Court has been brought in an improper or inconvenient forum.
SIGNATURE PAGE TO FOLLOW
IN WITNESS WHEREOF, the parties hereto have executed this Agreement on and as of the day and year first above written.
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COMPANY
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Menlo Therapeutics Inc.
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By:
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Name: Steven L. Basta
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Title: President
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INDEMNITEE
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By:
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Name:
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Address:
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INDEMNIFICATION AGREEMENT
THIS INDEMNIFICATION AGREEMENT (the “
Agreement
”) is made and entered into as of _______20__, by and between Menlo Therapeutics Inc., a Delaware corporation (the “
Company
”), and _______ (“
Indemnitee
”).
WITNESSETH THAT:
WHEREAS, highly competent persons have become more reluctant to serve corporations as directors or in other capacities unless they are provided with adequate protection through insurance or adequate indemnification against inordinate risks of claims and actions against them arising out of their service to and activities on behalf of the corporation;
WHEREAS, the Board of Directors of the Company (the “
Board
”) has determined that, in order to attract and retain qualified individuals, the Company will attempt to maintain on an ongoing basis, at its sole expense, liability insurance to protect persons serving the Company and its subsidiaries from certain liabilities. Although the furnishing of such insurance has been a customary and widespread practice among United States-based corporations and other business enterprises, the Company believes that, given current market conditions and trends, such insurance may be available to it in the future only at higher premiums and with more exclusions. At the same time, directors, officers, and other persons in service to corporations or business enterprises are being increasingly subjected to expensive and time-consuming litigation relating to, among other things, matters that traditionally would have been brought only against the Company or business enterprise itself. The Bylaws of the Company require indemnification of the officers and directors of the Company. Indemnitee may also be entitled to indemnification pursuant to the DGCL. The Bylaws and the DGCL expressly provide that the indemnification provisions set forth therein are not exclusive, and thereby contemplate that contracts may be entered into between the Company and members of the Board, officers and other persons with respect to indemnification;
WHEREAS, the uncertainties relating to such insurance and to indemnification have increased the difficulty of attracting and retaining such persons;
WHEREAS, the Board has determined that the increased difficulty in attracting and retaining such persons is detrimental to the best interests of the Company's stockholders and that the Company should act to assure such persons that there will be increased certainty of such protection in the future;
WHEREAS, it is reasonable, prudent and necessary for the Company contractually to obligate itself to indemnify, and to advance expenses on behalf of, such persons to the fullest extent permitted by applicable law, and subject to the exceptions set forth in this Agreement, so that they will serve or continue to serve the Company free from undue concern that they will not be so indemnified;
WHEREAS, this Agreement is a supplement to and in furtherance of the Bylaws and Certificate of Incorporation of the Company and any resolutions adopted pursuant thereto, and shall not be deemed a substitute therefor, nor to diminish or abrogate any rights of Indemnitee thereunder;
WHEREAS, Indemnitee does not regard the protection available under the Company's Bylaws and Certificate of Incorporation and insurance as adequate in the present circumstances, and may not be willing to serve as an officer or director without adequate protection, and the Company desires Indemnitee to serve in such capacity. Indemnitee is willing to serve, continue to serve and to take on additional service for or on behalf of the Company on the condition that he be so indemnified; and
WHEREAS, Indemnitee may have certain rights to indemnification and/or insurance provided by other entities and/or organizations (collectively, the “
Other Indemnitors
”) which Indemnitee and such Other Indemnitors intend to be secondary to the primary obligation of the Company to indemnify Indemnitee as provided herein, with the Company’s acknowledgement and agreement to the foregoing being a material condition to Indemnitee’s willingness to serve on the Board.
NOW, THEREFORE, in consideration of Indemnitee’s agreement to serve as a director after the date hereof, the parties hereto agree as follows:
1.
Indemnity of Indemnitee
. The Company hereby agrees to hold harmless and indemnify Indemnitee to the fullest extent permitted by the DGCL and the Company’s Certificate of Incorporation and Bylaws, and subject to any exceptions contained in this Agreement, as each may be amended from time to time. In furtherance of the foregoing indemnification, and without limiting the generality thereof:
(a)
Proceedings Other Than Proceedings by or in the Right of the Company
. Indemnitee shall be entitled to the rights of indemnification provided in this
Section l(a)
if, by reason of his Corporate Status (as hereinafter defined), the Indemnitee is, or is threatened to be made, a party to or participant in any Proceeding (as hereinafter defined) other than a Proceeding by or in the right of the Company. Pursuant to this
Section 1(a)
, Indemnitee shall be indemnified against all Expenses (as hereinafter defined), judgments, penalties, fines and amounts paid in settlement actually and reasonably incurred by him, or on his behalf, in connection with such Proceeding or any claim, issue or matter therein, 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 the Indemnitee’s conduct was unlawful.
(b)
Proceedings by or in the Right of the Company
. Indemnitee shall be entitled to the rights of indemnification provided in this
Section 1(b)
if, by reason of his Corporate Status, the Indemnitee is, or is threatened to be made, a party to or participant in any Proceeding brought by or in the right of the Company. Pursuant to this
Section 1(b)
, Indemnitee shall be indemnified against all Expenses actually and reasonably incurred by the Indemnitee, or on the Indemnitee’s behalf, 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, if applicable law so provides, no indemnification against such Expenses shall be made in respect of any claim, issue or matter in such Proceeding as to which Indemnitee shall have been adjudged to be liable to the Company unless and to the extent that the Court of Chancery of the State of Delaware shall determine that such indemnification may be made.
(c)
Indemnification for Expenses of a Party Who is Wholly or Partly Successful
. Notwithstanding any other provision of this Agreement, to the extent that Indemnitee is, by reason of his Corporate Status, a party to and is successful, on the merits or otherwise, in any Proceeding, he shall be indemnified to the maximum extent permitted by law, as such may be amended from time to time, against all Expenses actually and reasonably incurred by him or on his behalf in connection therewith. If Indemnitee is not wholly successful in such Proceeding but is successful, on the merits or otherwise, as to one or more but less than all claims, issues or matters in such Proceeding, the Company shall indemnify Indemnitee against all Expenses actually and reasonably incurred by him or on his behalf in connection with each successfully resolved claim, issue or matter. For purposes of this Section and without limitation, the termination of any claim, issue or matter in such a Proceeding by dismissal, with or without prejudice, shall be deemed to be a successful result as to such claim, issue or matter.
2.
Additional Indemnity
. In addition to, and without regard to any limitations on, the indemnification provided for in
Section 1
of this Agreement, the Company shall and hereby does indemnify and hold harmless Indemnitee against all Expenses, judgments, penalties, fines and amounts paid in settlement actually and reasonably incurred by him or on his behalf if, by reason of his Corporate Status, he is, or is threatened to be made, a party to or participant in any Proceeding (including a Proceeding by or in the right of the Company), including, without limitation, all liability arising out of the negligence or active or passive wrongdoing of Indemnitee. The only limitation that shall exist upon the Company’s obligations pursuant to this Agreement shall be that the Company shall not be obligated to make any payment to Indemnitee that is finally determined (under the procedures, and subject to the presumptions, set forth in
Sections 6
and
7
hereof) to be unlawful.
3.
Contribution
.
(a)
Whether or not the indemnification provided in
Sections 1
and
2
hereof is available, in respect of any threatened, pending or completed action, suit or proceeding in which the Company is jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding), the Company shall pay, in the first instance, the entire amount of any judgment or settlement of such action, suit or proceeding without requiring Indemnitee to contribute to such payment and the Company hereby waives and relinquishes any right of contribution it may have against Indemnitee. The Company shall not enter into any settlement of any action, suit or proceeding in which the Company is jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding) unless such settlement provides for a full and final release of all claims asserted against Indemnitee.
(b)
Without diminishing or impairing the obligations of the Company set forth in the preceding subparagraph, if, for any reason, Indemnitee shall elect or be required to pay all or any portion of any judgment or settlement in any threatened, pending or completed action, suit or proceeding in which the Company is jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding), the Company shall contribute to the amount of Expenses, judgments, fines and amounts paid in settlement actually and reasonably incurred and paid or payable by Indemnitee in proportion to the relative benefits received by the Company and all officers, directors or employees of the Company, other than Indemnitee, who are jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding), on the one hand, and Indemnitee, on the other hand, from the transaction from which such action, suit or proceeding arose; provided, however, that the proportion determined on the basis of relative benefit may, to the extent necessary to conform to law, be further adjusted by reference to the relative fault of the Company and all officers, directors or employees of the Company other than Indemnitee who are jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding), on the one hand, and Indemnitee, on the other hand, in connection with the events that resulted in such expenses, judgments, fines or settlement amounts, as well as any other equitable considerations which the Law may require to be considered. The relative fault of the Company and all officers, directors or employees of the Company, other than Indemnitee, who are jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding), on the one hand, and Indemnitee, on the other hand, shall be determined by reference to, among other things, the degree to which their actions were motivated by intent to gain personal profit or advantage, the degree to which their liability is primary or secondary and the degree to which their conduct is active or passive.
(c)
The Company hereby agrees to fully indemnify and hold Indemnitee harmless from any claims of contribution which may be brought by officers, directors or employees of the Company, other than Indemnitee, who may be jointly liable with Indemnitee.
(d)
To the fullest extent permissible under applicable law, if the indemnification provided for in this Agreement is unavailable to Indemnitee for any reason whatsoever, the Company, in lieu of indemnifying Indemnitee, shall contribute to the amount incurred by Indemnitee, whether for judgments, fines, penalties, excise taxes, amounts paid or to be paid in settlement and/or for Expenses, in connection with any claim relating to an indemnifiable event under this Agreement, in such proportion as is deemed fair and reasonable in light of all of the circumstances of such Proceeding in order to reflect (i) the relative benefits received by the Company and Indemnitee as a result of the event(s) and/or transaction(s) giving cause to such Proceeding; and/or (ii) the relative fault of the Company (and its directors, officers, employees and agents) and Indemnitee in connection with such event(s) and/or transaction(s).
4.
Indemnification for Expenses of a Witness
. Notwithstanding any other provision of this Agreement, to the extent that Indemnitee is, by reason of his Corporate Status, a witness in any Proceeding to which Indemnitee is not a party, he shall be indemnified against all Expenses actually and reasonably incurred by him or on his behalf in connection therewith.
5.
Advancement of Expenses
. Notwithstanding any other provision of this Agreement, the Company shall advance all Expenses incurred by or on behalf of Indemnitee in connection with any Proceeding by reason of Indemnitee’s Corporate Status within thirty (30) days after the receipt by the Company of a statement or statements from Indemnitee requesting such advance or advances from time to time, whether prior to or after final disposition of such Proceeding. Such statement or statements shall reasonably evidence the Expenses incurred by Indemnitee, shall include such documentation and information as is reasonably available to the Indemnitee and is reasonably necessary for the Reviewing Party (defined below) to determine whether and to what extent the Indemnitee is entitled to advancement of expenses, and shall include or be preceded or accompanied by an undertaking by or on behalf of Indemnitee to repay any Expenses advanced if it shall ultimately be determined by the Reviewing Party that Indemnitee is not entitled to be indemnified against such Expenses. Any advances and undertakings to repay pursuant to this
Section 5
shall be (i) unsecured and interest free, (ii) shall be made without regard to the Indemnitee’s ability to repay the advances and without regard to the Indemnitee’s ultimate entitlement to indemnification under the other provisions of this Agreement, and (iii) shall include any and all reasonable Expenses incurred pursuing an action to enforce this right of advancement, including Expenses incurred preparing and forwarding statements to the Company to support the advances claimed. The Indemnitee shall qualify for advancement of Expenses solely upon the execution and delivery to the Company of an unsecured undertaking providing that the Indemnitee undertakes to repay the advance to the extent and only to the extent that it is ultimately determined that the Indemnitee is not entitled to be indemnified by the Company.
6.
Procedures and Presumptions for Determination of Entitlement to Indemnification; Change in Control
. It is the intent of this Agreement to secure for Indemnitee rights of indemnity that are as favorable as may be permitted under the DGCL and public policy of the State of Delaware. Accordingly, the parties agree that the following procedures and presumptions shall apply in the event of any question as to whether Indemnitee is entitled to indemnification under this Agreement:
(a)
To obtain indemnification under this Agreement, Indemnitee shall submit to the Company a written request, including therein or therewith such documentation and information as is reasonably available to Indemnitee and is reasonably necessary for the Reviewing Party to determine whether and to what extent Indemnitee is entitled to indemnification. The Secretary of the Company shall, promptly upon receipt of such a request for indemnification, advise the Board in writing that Indemnitee has requested indemnification.
(b)
Upon written request by Indemnitee for indemnification pursuant to the first sentence of
Section 6(a)
hereof, a determination, if required by applicable law, with respect to Indemnitee’s entitlement thereto shall be made either: (1) by a majority vote of the Disinterested Directors, even though less than a quorum, or by a committee of Disinterested Directors designated by a majority vote of the Disinterested Directors, even though less than a quorum, or (2) if there has been a Change in Control, other than a Change in Control which has been approved by a majority of Company’s Board of Directors who were directors immediately prior to such Change in Control, by Independent Counsel in a written opinion to the Board, a copy of which shall be delivered to the Indemnitee (such person or body, the “
Reviewing Party
”).
(c)
The Company agrees that if there is a Change in Control of the Company, other than a Change in Control which has been approved by a majority of the Company’s Board of Directors who were directors immediately prior to such Change in Control, then with respect to all matters thereafter arising concerning the rights of the Indemnitee to indemnification and Expenses under this Agreement or any other agreement or under applicable law or the Company’s Certificate of Incorporation or Bylaws now or hereafter in effect relating to indemnification for Indemnifiable Events, including any determination of entitlement to indemnification to be made pursuant to
Section 6(b)(2)
hereof, the Company shall seek legal advice only from Independent Counsel shall be selected as provided in this
Section 6(c)
. The Independent Counsel shall be selected by the indemnitee, shall meet the requirements of “
Independent Counsel
” as defined in
Section 13
of this Agreement, and shall be subject to approval by the Company, which approval shall not be unreasonably withheld. Such counsel, among other things, shall render its written opinion to the Company and the Indemnitee as to whether and to what extent the Indemnitee would be permitted to be indemnified under this Agreement. If, within 20 days after submission by Indemnitee of a written request for indemnification pursuant to
Section 6(a)
hereof, no Independent Counsel shall have been selected and not objected to, either the Company or Indemnitee may petition the Court of Chancery of the State of Delaware or other court of competent jurisdiction for resolution of any objection which shall have been made by the Indemnitee to the Company’s selection of Independent Counsel and/or for the appointment as Independent Counsel of a person selected by the court or by such other person as the court shall designate, and the person with respect to whom all objections are so resolved or the person so appointed shall act as Independent Counsel under
Section 6(b)
hereof. The Company shall pay any and all reasonable fees and expenses of Independent Counsel incurred by such Independent Counsel in connection with acting pursuant to
Section 6(b)
hereof, and the Company shall pay all reasonable fees and expenses incident to the procedures of this
Section 6(c)
, regardless of the manner in which such Independent Counsel was selected or appointed.
(d)
In making a determination with respect to entitlement to indemnification hereunder, the Reviewing Party shall presume that Indemnitee is entitled to indemnification under this Agreement. Anyone seeking to overcome this presumption shall have the burden of proof and the burden of persuasion by clear and convincing evidence. Neither the failure of the Company (including by its directors or independent legal counsel) to have made a determination prior to the commencement of any action pursuant to this Agreement that indemnification is proper in the circumstances because Indemnitee has met the applicable standard of conduct, nor an actual determination by the Company (including by its directors or independent legal counsel) that Indemnitee has not met such applicable standard of conduct, shall be a defense to the action or create a presumption that Indemnitee has not met the applicable standard of conduct.
(e)
Indemnitee shall be deemed to have acted in good faith if Indemnitee’s action is based on the records or books of account of the Enterprise, including financial statements, or
on information supplied to Indemnitee by the officers of the Enterprise (as hereinafter defined) in the course of their duties, or on the advice of legal counsel for the Enterprise or on information or records given or reports made to the Enterprise by an independent certified public accountant or by an appraiser or other expert selected with reasonable care by the Enterprise. In addition, the knowledge and/or actions, or failure to act, of any director, officer, agent or employee of the Enterprise shall not be imputed to Indemnitee for purposes of determining the right to indemnification under this Agreement. Whether or not the foregoing provisions of this
Section 6(e)
are satisfied, it shall in any event be presumed that Indemnitee has at all times acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the Company. Anyone seeking to overcome this presumption shall have the burden of proof and the burden of persuasion by clear and convincing evidence.
(f)
If the Reviewing Party empowered or selected under
Section 6
to determine whether Indemnitee is entitled to indemnification shall not have made a determination within sixty (60) days after receipt by the Company of the request therefor, the requisite determination of entitlement to indemnification shall be deemed to have been made and Indemnitee shall be entitled to such indemnification absent (i) a misstatement by Indemnitee of a material fact, or an omission of a material fact necessary to make Indemnitee’s statement not materially misleading, in connection with the request for indemnification, or (ii) a prohibition of such indemnification under applicable law; provided, however, that such 60-day period may be extended for a reasonable time, not to exceed an additional thirty (30) days, if the Reviewing Party in good faith requires such additional time to obtain or evaluate documentation and/or information relating thereto; and provided, further, that the foregoing provisions of this
Section 6(g)
shall not apply if the determination of entitlement to indemnification is to be made by the stockholders pursuant to
Section 6(b)
of this Agreement and if (A) within fifteen (15) days after receipt by the Company of the request for such determination, the Board or the Disinterested Directors, if appropriate, resolve to submit such determination to the stockholders for their consideration at an annual meeting thereof to be held within seventy-five (75) days after such receipt and such determination is made thereat, or (B) a special meeting of stockholders is called within fifteen (15) days after such receipt for the purpose of making such determination, such meeting is held for such purpose within sixty (60) days after having been so called and such determination is made thereat.
(g)
Indemnitee shall cooperate with the Reviewing Party, including providing to such Reviewing Party upon reasonable advance request any documentation or information which is not privileged or otherwise protected from disclosure and which is reasonably available to Indemnitee and reasonably necessary to such determination. Any Independent Counsel, member of the Board or stockholder of the Company shall act reasonably and in good faith in making a determination regarding the Indemnitee’s entitlement to indemnification under this Agreement. Any costs or expenses (including attorneys’ fees and disbursements) incurred by Indemnitee in so cooperating with the Reviewing Party shall be borne by the Company (irrespective of the determination as to Indemnitee’s entitlement to indemnification) and the Company hereby indemnifies and agrees to hold Indemnitee harmless therefrom.
(h)
The Company acknowledges that a settlement or other disposition short of final judgment may be successful if it permits a party to avoid expense, delay, distraction, disruption and uncertainty. In the event that any action, claim or proceeding to which Indemnitee is a party is resolved in any manner other than by adverse judgment against Indemnitee (including, without limitation, settlement of such action, claim or proceeding with or without payment of money or other consideration) it shall be presumed that Indemnitee has been successful on the merits or otherwise in such action, suit or proceeding. Anyone seeking to overcome this presumption shall have the burden of proof and the burden of persuasion by clear and convincing evidence.
(i)
The termination of any Proceeding or of any claim, issue or matter therein, by judgment, order, settlement or conviction, or upon a plea of nolo contendere or its equivalent, shall not (except as otherwise expressly provided in this Agreement) of itself adversely affect the right of Indemnitee to indemnification or create a presumption that Indemnitee did not act in good faith and in a manner which he reasonably believed to be in or not opposed to the best interests of the Company or, with respect to any criminal Proceeding, that Indemnitee had reasonable cause to believe that his conduct was unlawful.
7.
Remedies of Indemnitee
.
(a)
In the event that (i) a determination is made pursuant to
Section 6
of this Agreement that Indemnitee is not entitled to indemnification under this Agreement, (ii) advancement of Expenses is not timely made pursuant to
Section 5
of this Agreement, (iii) no determination of entitlement to indemnification is made pursuant to
Section 6(b)
of this Agreement within 90 days after receipt by the Company of the request for indemnification, (iv) payment of indemnification is not made pursuant to this Agreement within ten (10) days after receipt by the Company of a written request therefor or (v) payment of indemnification is not made within ten (10) days after a determination has been made that Indemnitee is entitled to indemnification or such determination is deemed to have been made pursuant to
Section 6
of this Agreement, Indemnitee shall be entitled to an adjudication in an appropriate court of the State of Delaware, or in any other court of competent jurisdiction, of Indemnitee’s entitlement to such indemnification. Indemnitee shall commence such proceeding seeking an adjudication within 180 days following the date on which Indemnitee first has the right to commence such proceeding pursuant to this
Section 7(a)
. The Company shall not oppose Indemnitee’s right to seek any such adjudication.
(b)
In the event that a determination shall have been made pursuant to
Section 6(b)
of this Agreement that Indemnitee is not entitled to indemnification, any judicial proceeding commenced pursuant to this
Section 7
shall be conducted in all respects as a de novo trial on the merits, and Indemnitee shall not be prejudiced by reason of the adverse determination under
Section 6(b)
.
(c)
If a determination shall have been made pursuant to
Section 6(b)
of this Agreement that Indemnitee is entitled to indemnification, the Company shall be bound by such determination in any judicial proceeding commenced pursuant to this
Section 7
, absent (i) a misstatement by Indemnitee of a material fact, or an omission of a material fact necessary to make Indemnitee’s misstatement not materially misleading in connection with the application for indemnification, or (ii) a prohibition of such indemnification under applicable law.
(d)
In the event that Indemnitee, pursuant to this
Section 7
, seeks a judicial adjudication of his rights under, or to recover damages for breach of, this Agreement, or to recover under any directors’ and officers’ liability insurance policies maintained by the Company, the Company shall pay on his behalf, in advance, any and all expenses (of the types described in the definition of Expenses in
Section 13
of this Agreement) actually and reasonably incurred by him in such judicial adjudication, regardless of whether Indemnitee ultimately is determined to be entitled to such indemnification, advancement of expenses or insurance recovery.
(e)
The Company shall be precluded from asserting in any judicial proceeding commenced pursuant to this
Section 7
that the procedures and presumptions of this Agreement are not valid, binding and enforceable and shall stipulate in any such court that the Company is bound by all the provisions of this Agreement. The Company shall indemnify Indemnitee against any and all Expenses and, if requested by Indemnitee, shall (within ten (10) days after receipt by the Company of a written request therefore) advance, to the extent not prohibited by law, such expenses to Indemnitee, which are
incurred by Indemnitee in connection with any action brought by Indemnitee for indemnification or advance of Expenses from the Company under this Agreement or under any directors' and officers' liability insurance policies maintained by the Company, regardless of whether Indemnitee ultimately is determined to be entitled to such indemnification, advancement of Expenses or insurance recovery, as the case may be.
(f)
Notwithstanding anything in this Agreement to the contrary, no determination as to entitlement to indemnification under this Agreement shall be required to be made prior to the final disposition of the Proceeding.
8.
Non-Exclusivity; Survival of Rights; Insurance; Primacy of Indemnification; Subrogation
.
(a)
The rights of indemnification as provided by this Agreement shall not be deemed exclusive of any other rights to which Indemnitee may at any time be entitled under applicable law, the certificate of incorporation of the Company, the Bylaws, any agreement, a vote of stockholders, a resolution of directors or otherwise. No amendment, alteration or repeal of this Agreement or of any provision hereof shall limit or restrict any right of Indemnitee under this Agreement in respect of any action taken or omitted by such Indemnitee in his Corporate Status prior to such amendment, alteration or repeal. To the extent that a change in the DGCL, whether by statute or judicial decision, permits greater indemnification than would be afforded currently under the Bylaws and this Agreement, it is the intent of the parties hereto that Indemnitee shall enjoy by this Agreement the greater benefits so afforded by such change. No right or remedy herein conferred is intended to be exclusive of any other right or remedy, and every other right and remedy shall be cumulative and in addition to every other right and remedy given hereunder or now or hereafter existing at law or in equity or otherwise. The assertion or employment of any right or remedy hereunder, or otherwise, shall not prevent the concurrent assertion or employment of any other right or remedy.
(b)
To the extent that the Company maintains an insurance policy or policies providing liability insurance for directors, officers, employees, or agents or fiduciaries of the Company or of any other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise that such person serves at the request of the Company, Indemnitee shall be covered by such policy or policies in accordance with its or their terms to the maximum extent of the coverage available for any director, officer, employee, agent or fiduciary under such policy or policies. If, at the time of the receipt of a notice of a claim pursuant to the terms hereof, the Company has director and officer liability insurance in effect, the Company shall give prompt notice of the commencement of such proceeding to the insurers in accordance with the procedures set forth in the respective policies. The Company shall thereafter take all necessary or desirable action to cause such insurers to pay, on behalf of the Indemnitee, all amounts payable as a result of such proceeding in accordance with the terms of such policies.
(c)
The Company hereby acknowledges that Indemnitee may have certain rights to indemnification, advancement of expenses and/or insurance provided by the Other Indemnitors. The Company hereby agrees (i) that it is the indemnitor of first resort (i.e., its obligations to Indemnitee are primary and any obligation of the Other Indemnitors to advance expenses or to provide indemnification for the same expenses or liabilities incurred by Indemnitee are secondary), (ii) that it shall be required to advance the full amount of expenses incurred by Indemnitee and shall be liable for the full amount of all Expenses, judgments, penalties, fines and amounts paid in settlement to the extent legally permitted and as required by the terms of this Agreement and the Certificate of Incorporation or Bylaws of the Company (or any other agreement between the Company and Indemnitee), without regard to any rights Indemnitee may have against the Other Indemnitors, and, (iii) that it irrevocably waives,
relinquishes and releases the Other Indemnitors from any and all claims against the Other Indemnitors for contribution, subrogation or any other recovery of any kind in respect thereof. The Company further agrees that no advancement or payment by the Other Indemnitors on behalf of Indemnitee with respect to any claim for which Indemnitee has sought indemnification from the Company shall affect the foregoing and the Other Indemnitors shall have a right of contribution and/or be subrogated to the extent of such advancement or payment to all of the rights of recovery of Indemnitee against the Company. The Company and Indemnitee agree that the Other Indemnitors are express third party beneficiaries of the terms of this Section 8(c).
(d)
Except as provided in paragraph (c) above, in the event of any payment under this Agreement, the Company shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee (other than against the Other Indemnitors), who shall execute all papers required and take all action necessary to secure such rights, including execution of such documents as are necessary to enable the Company to bring suit to enforce such rights.
(e)
Except as provided in paragraph (c) above, the Company shall not be liable under this Agreement to make any payment of amounts otherwise indemnifiable hereunder if and to the extent that Indemnitee has otherwise actually received such payment under any insurance policy, contract, agreement or otherwise.
(f)
Except as provided in paragraph (c) above, the Company's obligation to indemnify or advance Expenses hereunder to Indemnitee who is or was serving at the request of the Company as a director, officer, employee or agent of any other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise shall be reduced by any amount Indemnitee has actually received as indemnification or advancement of expenses from such other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise.
9.
Exception to Right of Indemnification
. Notwithstanding any provision in this Agreement, the Company shall not be obligated under this Agreement to make any indemnity in connection with any claim made against Indemnitee:
(a)
for which payment has actually been made to or on behalf of Indemnitee under any insurance policy or other indemnity provision, except with respect to any excess beyond the amount paid under any insurance policy or other indemnity provision, provided, that the foregoing shall not affect the rights of Indemnitee or the Other Indemnitors set forth in Section 8(c) above; or
(b)
for an accounting of profits made from the purchase and sale (or sale and purchase) by Indemnitee of securities of the Company within the meaning of
Section 16(b)
of the Securities Exchange Act of 1934, as amended, or similar provisions of state statutory law or common law; or
(c)
in connection with any Proceeding (or any part of any Proceeding) initiated by Indemnitee, including any Proceeding (or any part of any Proceeding) initiated by Indemnitee against the Company or its directors, officers, employees or other indemnitees, unless (i) the Board authorized the Proceeding (or any part of any Proceeding) prior to its initiation or (ii) the Company provides the indemnification, in its sole discretion, pursuant to the powers vested in the Company under applicable law.
10.
Duration of Agreement
. All agreements and obligations of the Company contained herein shall continue during the period Indemnitee is an officer or director of the Company
(or is or was serving at the request of the Company as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise) and shall continue thereafter so long as Indemnitee shall be subject to any Proceeding (or any proceeding commenced under
Section 7
hereof) by reason of his Corporate Status, whether or not he is acting or serving in any such capacity at the time any liability or expense is incurred for which indemnification can be provided under this Agreement. This Agreement shall be binding upon and inure to the benefit of and be enforceable by the parties hereto and their respective successors (including any direct or indirect successor by purchase, merger, consolidation or otherwise to all or substantially all of the business or assets of the Company), assigns, spouses, heirs, executors and personal and legal representatives.
11.
Security
. To the extent requested by Indemnitee and approved by the Board, the Company may at any time and from time to time provide security to Indemnitee for the Company’s obligations hereunder through an irrevocable bank line of credit, funded trust or other collateral. Any such security, once provided to Indemnitee, may not be revoked or released without the prior written consent of the Indemnitee.
12.
Enforcement
.
(a)
The Company expressly confirms and agrees that it has entered into this Agreement and assumes the obligations imposed on it hereby in order to induce Indemnitee to serve as an officer or director of the Company, and the Company acknowledges that Indemnitee is relying upon this Agreement in serving as an officer or director of the Company.
(b)
This Agreement constitutes the entire agreement between the parties hereto with respect to the subject matter hereof and supersedes all prior agreements and understandings, oral, written and implied, between the parties hereto with respect to the subject matter hereof.
13.
Definitions
. For purposes of this Agreement:
(a)
A “
Change in Control
” shall be deemed to have occurred if:
(i)
any “person,” as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder (the “
Exchange Act
”) hereafter becomes the “beneficial owner,” as defined in Rule 13d‑3 of the Exchange Act, directly or indirectly, of securities of the Company representing 20% or more of the total combined voting power represented by the Company’s then outstanding Voting Securities, other than (a) a trustee or other fiduciary holding securities under an employee benefit plan of the Company; (b) a corporation owned, directly or indirectly, by the stockholders of the Company in substantially the same proportions as their ownership of stock of the Company; or (c) any current beneficial stockholder or group, as defined by Rule 13d-5 of the Exchange Act, including the heirs, assigns and successors thereof, of beneficial ownership, within the meaning of Rule 13d‑3 of the Exchange Act, of securities possessing more than 50% of the total combined voting power of the Company’s outstanding securities;
(ii)
during any period of two consecutive years, individuals who at the beginning of such period constitute the Board and any new director whose election by the Board or nomination for election by the Company’s stockholders was approved by a vote of at least two-thirds of the directors then in office who either were directors at the beginning of the period or whose election or nomination for election was previously so approved, cease for any reason to constitute a majority thereof; or
(iii)
the stockholders of the Company approve a merger or consolidation of the Company with any other corporation, other than a merger or consolidation which would result in the Voting Securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into Voting Securities of the surviving entity) at least 80% of the total voting power represented by the Voting Securities of the Company or such surviving entity outstanding immediately after such merger or consolidation, or the stockholders of the Company approve a plan of complete liquidation of the Company or an agreement for the sale or disposition by the Company, in one transaction or a series of transactions, of all or substantially all of the Company’s assets.
(b)
“
Corporate Status
” describes the status of a person who is or was a director, officer, employee, agent or fiduciary of the Company or of any other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise that such person is or was serving at the express written request of the Company.
(c)
“
DGCL
” shall mean the General Corporation law of the State of Delaware, as the same exists or may hereafter be amended or interpreted; provided, however, that in the case of any such amendment or interpretation, only to the extent that such amendment or interpretation permits the Company to provide broader rights to indemnification or advancement of expenses than were permitted prior thereto.
(d)
“
Disinterested Director
” means a director of the Company who is not and was not a party to the Proceeding in respect of which indemnification is sought by Indemnitee.
(e)
“
Enterprise
” shall mean the Company and any other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise that Indemnitee is or was serving at the express written request of the Company as a director, officer, employee, agent or fiduciary.
(f)
“
Expenses
” shall include all reasonable attorneys’ fees, retainers, court costs, transcript costs, fees of experts, witness fees, travel expenses, duplicating costs, printing and binding costs, telephone charges, postage, delivery service fees and all other disbursements or expenses of the types customarily incurred in connection with prosecuting, defending, preparing to prosecute or defend, investigating, participating, or being or preparing to be a witness in a Proceeding. Expenses also shall include Expenses incurred in connection with any appeal resulting from any Proceeding, including without limitation the premium, security for, and other costs relating to any cost bond, supersede as bond, or other appeal bond or its equivalent. Expenses shall also include any liability of the lawful spouse (whether such status is derived by reason of the statutory law, common law or otherwise of any applicable jurisdiction) of the Indemnitee arising out of that person’s capacity as the spouse of the Indemnitee in connection with an Indemnifiable Event, including, without limitation, liability for damages recovered from marital community property, property jointly held by the Indemnitee and the spouse or property transferred from the Indemnitee to the spouse. Expenses, however, shall not include amounts paid in settlement by Indemnitee or the amount of judgments or fines against Indemnitee.
(g)
“
Indemnifiable Event
” means any event or occurrence that takes place either prior to, on or after the execution of this Agreement, related to or arising out of the fact that the Indemnitee is or was a director or officer of the Company, or is or was serving at the request of the Company as a director, officer, employee, or agent of another corporation or of a partnership, joint venture, trust or other enterprise, including service with respect to employee benefit plans, relating to or by arising out of anything done or not done by the Indemnitee in any such capacity.
(h)
“
Independent Counsel
” means a law firm, or a member of a law firm, that is experienced in matters of corporation law and neither presently is, nor in the past five years has been, retained to represent: (i) the Company or Indemnitee in any matter material to either such party (other than with respect to matters concerning Indemnitee under this Agreement, or of other indemnitees under similar indemnification agreements), or (ii) any other party to the Proceeding giving rise to a claim 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 Indemnitee in an action to determine Indemnitee’s rights under this Agreement. The Company agrees to pay the reasonable fees of the Independent Counsel referred to above and to fully indemnify such counsel against any and all Expenses, claims, liabilities and damages arising out of or relating to this Agreement or its engagement pursuant hereto.
(i)
“
Proceeding
” includes any threatened, pending or completed action, suit, arbitration, alternate dispute resolution mechanism, investigation or inquiry (whether formal or informal), administrative hearing or any other actual, threatened or completed proceeding, whether brought by or in the right of the Company or otherwise and whether civil, criminal, administrative or investigative, in which Indemnitee was, is or will be involved as a party or otherwise, by reason of the fact that Indemnitee is or was an officer or director of the Company, by reason of any action taken by him or of any inaction on his part while acting as an officer or director of the Company, or by reason of the fact that he is or was serving at the request of the Company as a director, officer, employee, agent or fiduciary of another corporation, partnership, joint venture, trust or other Enterprise; in each case whether or not he is acting or serving in any such capacity at the time any liability or expense is incurred for which indemnification can be provided under this Agreement; including one pending on or before the date of this Agreement, but excluding one initiated by an Indemnitee pursuant to
Section 5
or
Section 7
of this Agreement to enforce his rights under this Agreement.
(j)
“
Voting Securities
” shall mean any securities of the Company which vote generally in the election of directors.
14.
Severability
. The invalidity or unenforceability of any provision hereof shall in no way affect the validity or enforceability of any other provision. Without limiting the generality of the foregoing, this Agreement is intended to confer upon Indemnitee indemnification rights to the fullest extent permitted by applicable laws. In the event any provision hereof conflicts with any applicable law, such provision shall be deemed modified, consistent with the aforementioned intent, to the extent necessary to resolve such conflict.
15.
Modification and Waiver
. No supplement, modification, termination or amendment of this Agreement shall be binding unless executed in writing by both of the parties hereto. No waiver of any of the provisions of this Agreement shall be deemed or shall constitute a waiver of any other provisions hereof (whether or not similar) nor shall such waiver constitute a continuing waiver.
16.
Notice By Indemnitee
. Indemnitee agrees promptly to notify the Company in writing upon being served with or otherwise receiving any summons, citation, subpoena, complaint, indictment, information or other document relating to any Proceeding or matter which may be subject to indemnification covered hereunder. The failure to so notify the Company shall not relieve the Company of any obligation which it may have to Indemnitee under this Agreement or otherwise unless and only to the extent that such failure or delay materially prejudices the Company.
17.
Notices
. All notices and other communications given or made pursuant to this Agreement shall be in writing and shall be deemed effectively given: (a) upon personal delivery to the party to be notified, (b) when sent by confirmed electronic mail or facsimile if sent during normal business hours of the recipient, and if not so confirmed, then on the next business day, (c) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one (1) day after deposit with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt. All communications shall be sent:
(b)
To Indemnitee at the address set forth below Indemnitee signature hereto.
(c)
To the Company at:
Menlo Therapeutics, Inc.
200 Cardinal Way, 2
nd
Floor
Redwood City, CA 94063
Attention: President
or to such other address as may have been furnished to Indemnitee by the Company or to the Company by Indemnitee, as the case may be.
18.
Counterparts
. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same Agreement. This Agreement may also be executed and delivered by facsimile signature and in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
19.
Headings
. The headings of the paragraphs 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.
20.
Governing Law and Consent to Jurisdiction.
This Agreement and the legal relations among the parties shall be governed by, and construed and enforced in accordance with, the laws of the State of Delaware, without regard to its conflict of laws rules. The Company and Indemnitee hereby irrevocably and unconditionally (i) agree that any action or proceeding arising out of or in connection with this Agreement shall be brought only in the Chancery Court of the State of Delaware (the “
Delaware Court
”), and not in any other state or federal court in the United States of America or any court in any other country, (ii) consent to submit to the exclusive jurisdiction of the Delaware Court for purposes of any action or proceeding arising out of or in connection with this Agreement, (iii) appoint, to the extent such party is not otherwise subject to service of process in the State of Delaware, The Corporation Trust Company, Wilmington, Delaware as its agent in the State of Delaware as such party's agent for acceptance of legal process in connection with any such action or proceeding against such party with the same legal force and validity as if served upon such party personally within the State of Delaware, (iv) waive any objection to the laying of venue of any such action or proceeding in the Delaware Court, and (v) waive, and agree not to plead or to make, any claim that any such action or proceeding brought in the Delaware Court has been brought in an improper or inconvenient forum.
SIGNATURE PAGE TO FOLLOW
IN WITNESS WHEREOF, the parties hereto have executed this Agreement on and as of the day and year first above written.
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COMPANY
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Menlo Therapeutics Inc.
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By:
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Name:
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Steven L. Basta
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Title:
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President
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INDEMNITEE
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By:
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Name:
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Address:
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Exhibit 10.4(a)
EXECUTION VERSION
TIGERCAT PHARMA, INC.
__________________________
2011 STOCK INCENTIVE PLAN
__________________________
ARTICLE I
PURPOSE
The purpose of the Plan is to enhance the profitability and value of the Company for the benefit of its stockholders by enabling the Company to offer Eligible Employees, Consultants and Non-Employee Directors stock-based incentives in the Company to attract, retain and reward such individuals and strengthen the mutuality of interests between such individuals and the Company’s stockholders.
ARTICLE II
DEFINITIONS
For purposes of the Plan, the following terms shall have the following meanings:
2.1
“
Acquisition Event
” means a merger or consolidation in which the Company is not the surviving entity, any transaction that results in the acquisition of all or substantially all of the Company’s outstanding Common Stock by a single person or entity or by a group of persons and/or entities acting in concert, or the sale or transfer of all or substantially all of the Company’s assets. The occurrence of an Acquisition Event shall be determined by the Committee in its sole discretion.
2.2
“
Affiliate
” means each of the following: (a) any Subsidiary; (b) any Parent; (c) any corporation, trade or business (including, without limitation, a partnership or limited liability company) that is directly or indirectly controlled 50% or more (whether by ownership of stock, assets or an equivalent ownership interest or voting interest) by the Company or one of its Affiliates; (d) any corporation, trade or business (including, without limitation, a partnership or limited liability company) that directly or indirectly controls 50% or more (whether by ownership of stock, assets or an equivalent ownership interest or voting interest) of the Company; and (e) any other entity in which the Company or any of its Affiliates has a material equity interest and that is designated as an “Affiliate” by resolution of the Committee; provided, however, that if the Common Stock subject to any Award does not constitute “service recipient stock” for purposes of Section 409A of the Code the Company intends that such award shall be designed to be exempt from or comply with Section 409A of the Code.
2.3
“
Award
” means any award under the Plan of any Stock Option, Restricted Stock or Other Stock-Based Award. All Awards shall be subject to the terms of, a written or electronic agreement executed by the Company and the Participant. Any reference herein to an agreement in writing shall be deemed to include an electronic writing to the extent permitted by applicable law.
2.4
“
Board
” means the Board of Directors of the Company.
2.5
“
Cause
” means with respect to a Participant’s Termination of Employment or Termination of Consultancy from and after the date hereof, the following: (a) in the case where there is no employment agreement, consulting agreement, change in control agreement or similar agreement in
effect between the Company or an Affiliate and the Participant at the time of the grant of the Award (or where there is such an agreement but it does not define “cause” (or words of like import)), termination due to a Participant’s dishonesty, fraud, material insubordination, moral turpitude, willful misconduct, refusal to perform his or her duties or responsibilities for any reason other than illness or incapacity, as determined by the Committee in its sole discretion; or (b) in the case where there is an employment agreement, consulting agreement, change in control agreement or similar agreement in effect between the Company or an Affiliate and the Participant at the time of the grant of the Award or an Award agreement that defines “cause” (or words of like import), “cause” as defined under such agreement;
provided
,
however
, that with regard to any agreement under which the definition of “cause” only applies on
occurrence of a change in control, such definition of “cause” shall not apply until a change in control actually takes place and then only with regard to a termination thereafter. With respect to a Participant’s Termination of Directorship, “cause” means an act or failure to act that constitutes cause for removal of a director under applicable Delaware law.
2.6
“
Change in Control
” Unless otherwise determined by the Committee in the applicable Award agreement (or other written agreement approved by the Committee including, without limitation, an employment agreement), a “Change in Control” shall be deemed to have occurred if (i) any “person” or “group” (as such terms are used in Section 13(d) and Section 14(d) of the Securities Exchange Act of 1934, as amended), other than a corporation owned directly or indirectly by the stockholders of the Company in substantially the same proportions as their ownership of stock of the Company, is or becomes the “beneficial owner” (as defined in Rule 13d-3 under said Act), directly or indirectly, of securities of the Company representing more than 50% of the total voting power represented by the Company’s then outstanding voting securities, (ii) the Company merges or consolidates with any other corporation or entity, other than a merger or consolidation which would result in the voting securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity) the total voting power represented by the voting securities of the Company or such surviving entity outstanding immediately after such merger or consolidation, (iii) the sale or disposition by the Company, in one transaction or a series of transactions, of all or substantially all the Company’s assets, or (iv) the dissolution, liquidation or winding up of the Company.
2.7
“
Code
” means the Internal Revenue Code of 1986, as amended. Any reference to any section of the Code shall also be a reference to any successor provision and any Treasury Regulation promulgated thereunder.
2.8
“
Committee
” means a committee of the Board appointed from time to time by the Board. Notwithstanding the foregoing, if and to the extent that no Committee exists that has the authority to administer the Plan, the functions of the Committee shall be exercised by the Board and all references herein to the Committee shall be deemed references to the Board.
2.9
“
Common Stock
” means the common stock of the Company, par value $0.001 per share.
2.10
“
Company
” means Tigercat Pharma, Inc., a Delaware corporation, and its successors by operation of law.
2.11
“
Consultant
” means any Person who provides bona fide consulting or advisory services to the Company or its Affiliates.
2.12
“
Detrimental Activity
”
means:
(a)
disclosing, divulging, furnishing or making available to anyone at any time, except as necessary in the furtherance of Participant’s responsibilities to the Company or any of its Affiliates, either during or subsequent to Participant’s service relationship with the Company or its Affiliates, any knowledge or information with respect to confidential or proprietary information, methods, processes, plans or materials of the Company or any of its Affiliates, or with respect to any other confidential or proprietary aspects of the business of the Company or any of its Affiliates, acquired by the Participant at any time prior to the Participant’s Termination;
(b)
any activity while employed or performing services that results, or if known could reasonably be expected to result, in the Participant’s Termination that is classified by the Company as a termination for Cause;
(c)
(i) directly or indirectly soliciting, enticing or inducing any employee of the Company or of any of its Affiliates to be employed by any person, firm or corporation that is, directly or indirectly, in competition with the business or activities of the Company or any of its Affiliates; (ii) directly or indirectly approaching any such employee for these purposes; (iii) authorizing or knowingly approving the taking of such actions by other persons on behalf of any such person, firm or corporation, or assisting any such person, firm or corporation in taking such action; (iv) directly or indirectly soliciting, raiding, enticing or inducing any person, firm or corporation who or which is, or at any time from and after the date of grant of the Award was, a customer or prospective customer of the Company or of any of its Affiliates to become a customer for the same or similar products or services that it purchased from the Company or any of its Affiliates, or any other person, firm or corporation, or approaching any such customer for such purpose or authorizing or knowingly approving the taking of such actions by any other person;
(d)
the rendering of services for any organization, or engaging, directly or indirectly, in any business, which is competitive with the Company or an Affiliate, or the rendering of services to such organization or business if such organization or business is otherwise prejudicial to or in conflict with the interests of the Company or an Affiliate;
(e)
the Participant’s Disparagement, or inducement of others to do so, of the Company or an Affiliate or their past and present officers, directors, employees or products;
(f)
a breach of any agreement between the Participant and the Company or an Affiliate (including, without limitation, any employment agreement or noncompetition or nonsolicitation or confidentiality agreement).
Unless otherwise determined by the Committee at grant, Detrimental Activity shall not be deemed to occur after the end of the one-year period following the Participant’s Termination.
2.13 “
Disability
” means with respect to a Participant’s Termination, a permanent and total disability as defined in Section 22(e)(3) of the Code. A Disability shall only be deemed to occur at the time of the determination by the Committee of the Disability. Notwithstanding the foregoing, for Awards that are subject to Section 409A of the Code, Disability shall mean that a Participant is disabled under Section 409A(a)(2)(C)(i) or (ii) of the Code.
2.14
“
Disparagement
”
means making comments or statements to the press, the Company’s or
its Affiliates’ employees, consultants or any individual or entity with whom the Company or its Affiliates has a business relationship that could reasonably be expected to adversely affect in any manner: (a) the conduct of the business of the Company or its Affiliates (including, without limitation, any products or business plans or prospects); or (b) the business reputation of the Company or its Affiliates, or any of their products, or their past or present officers, directors or employees.
2.15
“
Effective Date
” means the effective date of the Plan as defined in
Article XV
.
2.16
“
Eligible Employee
” means each employee of the Company or an Affiliate.
2.17
“
Exchange Act
” means the Securities Exchange Act of 1934, as amended, and all rules and regulations promulgated thereunder. Any references to any section of the Exchange Act shall also be a reference to any successor provision.
2.18
“
Exercisable Awards
”
has the meaning set forth in
Section 4.2(d)
.
2.19
“
Fair Market Value
” means, unless otherwise required by any applicable provision of the Code, as of any date and except as provided below, (a) the last sales price reported for the Common Stock on the applicable date as reported on the principal established securities market on which it is then traded or if the Common Stock shall not have been reported or quoted on such date, on the first day prior thereto on which the Common Stock was reported or quoted; or (b) if the Company’s Common Stock is not traded on any established securities market, the price as determined by the Committee in whatever manner it considers appropriate, taking into account the requirements of Section 409A of the Code. For purposes of the grant of any Award, the applicable date shall be the trading day on which the Award is granted, or if such grant date is not a trading day, the trading day immediately prior to the date on which the Award is granted. For purposes of the exercise of any Award, the applicable date shall be the date a notice of exercise is received by the Company or, if not a day on which the applicable market is open, the next day that it is open.
2.20
“
Family Member
” means “family member” as defined in Rule 701 under the Securities Act or, following the filing of a Form S-8 pursuant to the Securities Act with respect to the Plan, as defined in Section A.1.(5) of the general instructions of Form S-8, as may be amended from time to time.
2.21
“
Incentive Stock Option
” means any Stock Option awarded to an Eligible Employee of the Company, its Subsidiaries or its Parent (if any) under the Plan intended to be and designated as an “Incentive Stock Option” within the meaning of Section 422 of the Code.
2.22
“
Non-Employee Director
” means a director or a member of the Board of the Company or the board of directors or manager of an Affiliate who is not an active employee of the Company or an Affiliate.
2.23
“
Non-Qualified Stock Option
” means any Stock Option awarded under the Plan that is not an Incentive Stock Option.
2.24
“
Other Extraordinary Event
” has the meaning set forth in
Section 4.2(b)
.
2.25
“
Other Stock-Based Award
” means an Award of Common Stock and other awards (including awards of cash) made pursuant to
Article VIII
that is valued in whole or in part by reference to, or is payable in or otherwise based on, Common Stock, including, without limitation, a restricted stock unit, performance share award, or an award valued by reference to an Affiliate.
2.26
“
Parent
” means any parent corporation of the Company within the meaning of Section 424(e) of the Code.
2.27
“
Participant
” means an Eligible Employee, Consultant or Non-Employee Director to whom an Award has been granted pursuant to the Plan.
2.28
“
Permissible Transferee
” means any Family Member.
2.29
“
Person
” means any individual, corporation, partnership, limited liability company, firm, joint venture, association, joint-stock company, trust, incorporated organization, governmental or regulatory or other entity.
2.30
“
Plan
” means this Tigercat Pharma, Inc. 2011 Stock Incentive Plan, as amended from time to time.
2.31
“
Registration Date
” means the first date after the Effective Date (a) on which the Company sells its Common Stock in a bona fide underwriting pursuant to a registration statement under the Securities Act or (b) any class of common equity securities of the Company is required to be registered under Section 12 of the Exchange Act.
2.32
“
Restricted Stock
” means a share of Common Stock issued under the Plan that is subject to restrictions pursuant to
Article VII
.
2.33
“
Restriction Period
” has the meaning set forth in
Section 7.1
with respect to Restricted Stock.
2.34
“
Section 4.2 Event
”
has the meaning set forth in
Section 4.2(b)
.
2.35
“
Section 409A of the Code
”
means the nonqualified deferred compensation rules under
Section 409A of the Code and any applicable Treasury Regulation or other official guidance promulgated thereunder.
2.36
“
Securities Act
” means the Securities Act of 1933, as amended, and all rules and regulations promulgated thereunder. Any reference to any section of the Securities Act shall also be a reference to any successor provision.
2.37
“
Stock Option
” or “
Option
” means any option to purchase shares of Common Stock granted to Eligible Employees, Non-Employee Directors or Consultants pursuant to
Article VI
. All Stock Options under the Plan shall be designated as Non-Qualified Stock Options or Incentive Stock Options, and shall be subject to the terms of, a written award agreement executed by the Company and the Participant.
2.38
“
Subsidiary
” means any subsidiary corporation of the Company within the meaning of Section 424(f) of the Code.
2.39
“
Ten Percent Stockholder
” means a person owning stock possessing more than 10% of the total combined voting power of all classes of stock of the Company, its Subsidiaries or its Parent.
2.40
“
Termination
” means a Termination of Consultancy, Termination of Directorship or Termination of Employment, as applicable.
2.41
“
Termination of Consultancy
” means: (a) that the Consultant is no longer acting as a consultant to the Company or an Affiliate; or (b) when an entity that is retaining a Participant as a Consultant ceases to be an Affiliate unless the Participant otherwise is, or thereupon becomes, a Consultant to the Company or another Affiliate at the time the entity ceases to be an Affiliate. In the event that a Consultant becomes or is an Eligible Employee or a Non-Employee Director upon the termination of his or her consultancy, unless otherwise determined by the Committee, in its sole discretion, no Termination of Consultancy shall be deemed to occur until such time as such Consultant is no longer a Consultant, an Eligible Employee or a Non-Employee Director. Notwithstanding the foregoing, the Committee may, in its sole discretion, otherwise define Termination of Consultancy in the Award agreement or, if no rights of a Participant are reduced, may otherwise define Termination of Consultancy thereafter.
2.42
“
Termination of Directorship
” means that the Non-Employee Director has ceased to be a director of the Company or an Affiliate; except that if a Non-Employee Director becomes an Eligible Employee or a Consultant upon the termination of his or her directorship, his or her ceasing to be a director of the Company shall not be treated as a Termination of Directorship unless and until the Participant has a Termination of Employment or Termination of Consultancy, as the case may be.
2.43
“
Termination of Employment
” means: (a) a termination of employment (for reasons other than a military or approved personal leave of absence) of a Participant from the Company and its Affiliates; or (b) when an entity that is employing a Participant ceases to be an Affiliate, unless the Participant otherwise is, or thereupon becomes, employed by the Company or another Affiliate at the time the entity ceases to be an Affiliate. In the event that an Eligible Employee becomes or is a Consultant or a Non-Employee Director upon the termination of his or her employment, unless otherwise determined by the Committee, in its sole discretion, no Termination of Employment shall be deemed to occur until such time as such Eligible Employee is no longer an Eligible Employee, a Consultant or a Non-Employee Director. Notwithstanding the foregoing, the Committee may, in its sole discretion, otherwise define Termination of Employment in the Award agreement or, if no rights of a Participant are reduced, may otherwise define Termination of Employment thereafter.
2.44
“
Transfer
” means: (a) when used as a noun, any direct or indirect transfer, sale, assignment, pledge, hypothecation, encumbrance or other disposition (including the issuance of equity in a Person), whether for value or no value and whether voluntary or involuntary (including by operation of law), and (b) when used as a verb, to directly or indirectly transfer, sell, assign, pledge, encumber, charge, hypothecate or otherwise dispose of (including the issuance of equity in a Person) whether for value or for no value and whether voluntarily or involuntarily (including by operation of law). “Transferred” and “Transferrable” shall have a correlative meaning.
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2.45
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“
VPH
” means Velocity Pharmaceutical Holdings, LLC.
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ARTICLE III
ADMINISTRATION
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3.1
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The Committee
. The Plan shall be administered and interpreted by the Committee.
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3.2
Grants of Awards
. The Committee shall have full authority to grant, pursuant to the
terms of the Plan, to Eligible Employees, Consultants and Non-Employee Directors: (i) Stock Options, Restricted Stock and (iii) Other Stock-Based Awards. In particular, the Committee shall have the authority:
(a)
to select the Eligible Employees, Consultants and Non-Employee Directors to whom Awards may from time to time be granted hereunder;
(b)
to determine whether and to what extent Awards are to be granted hereunder to one or more Eligible Employees, Consultants or Non-Employee Directors;
(c)
to determine, in accordance with the terms of the Plan, the number of shares of Common Stock to be covered by each Award granted hereunder;
(d)
to determine the terms and conditions, not inconsistent with the terms of the Plan, of any Award granted hereunder (including, but not limited to, the exercise or purchase price (if any), any restriction or limitation, any vesting schedule or acceleration thereof, or any forfeiture restrictions or waiver thereof, regarding any Award and the shares of Common Stock relating thereto, based on such factors, if any, as the Committee shall determine, in its sole discretion);
(e)
to determine whether, to what extent and under what circumstances grants of Awards under the Plan are to operate on a tandem basis and/or in conjunction with or apart from other awards made by the Company outside of the Plan;
(f)
to determine whether and under what circumstances a Stock Option may be settled in cash, Common Stock and/or Restricted Stock under
Section 6.3
;
(g)
to determine whether a Stock Option is an Incentive Stock Option or Non-Qualified Stock Option;
(h)
to determine whether to require an Eligible Employee, Non-Employee Director or Consultant, as a condition of the granting of any Award, not to sell or otherwise dispose of shares of Common Stock acquired pursuant to an Award for a period of time as determined by the Committee, in its sole discretion, following the date of the Award;
(i)
to modify, extend or renew an Award, subject to
Article XI
, provided, however, that if a Stock Option is modified, extended or renewed and thereby deemed to be the issuance of a new Stock Option under the Code or the applicable accounting rules, the exercise price of a Stock Option may continue to be the original exercise price even if less than the Fair Market Value of the Common Stock at the time of such modification, extension or renewal;
(j)
solely to the extent permitted by applicable law, to determine whether, to what extent and under what circumstances to provide loans (which may be on a recourse basis and shall bear interest at the rate the Committee shall provide) to Participants in order to exercise Awards or to purchase or pay for shares of Common Stock issuable pursuant to Awards under the Plan; and
(k)
generally, to exercise such powers and to perform such acts as the Committee deems necessary or expedient to promote the best interests of the Company that are not in conflict with the provisions of the Plan.
3.3
Guidelines
. Subject to
Article XI
, the Committee shall, in its sole discretion, have the
authority to adopt, alter and repeal such administrative rules, guidelines and practices governing the Plan and perform all acts, including the delegation of its administrative responsibilities (to the extent permitted by applicable law and applicable stock exchange rules), as it shall, from time to time, deem advisable; to construe and interpret the terms and provisions of the Plan and any Award granted under the Plan (and
any agreements relating thereto) and to otherwise supervise the administration of the Plan. The Committee may, in its sole discretion, correct any defect, supply any omission or reconcile any inconsistency in the Plan or in any agreement relating thereto in the manner and to the extent it shall deem necessary to effectuate the purpose and intent of the Plan. The Committee may, in its sole discretion, adopt special guidelines and provisions for persons who are residing in or employed in, or subject to, the taxes of, any domestic or foreign jurisdictions to comply with applicable tax and securities laws and may impose any limitations and restrictions that it deems necessary to comply with the applicable tax and securities laws of such domestic or foreign jurisdictions.
3.4
Decisions Final
. Any decision, interpretation or other action made or taken in good faith
by or at the direction of the Company, the Board or the Committee (or any of its members) arising out of or in connection with the Plan shall be within the absolute discretion of all and each of them, as the case may be, and shall be final, binding and conclusive on the Company and all employees and Participants and their respective heirs, executors, administrators, successors and assigns.
3.5
Procedures
. If the Committee is appointed, the Board shall designate one of the members
of the Committee as chairman and the Committee shall hold meetings, subject to the By-Laws of the Company, at such times and places as it shall deem advisable, including, without limitation, by telephone conference or by written consent to the extent permitted by applicable law. A majority of the Committee members shall constitute a quorum. All determinations of the Committee shall be made by a majority of its members. Any decision or determination reduced to writing and signed by all the Committee members in accordance with the By-Laws of the Company, shall be as fully effective as if it had been made by a vote at a meeting duly called and held. The Committee shall keep minutes of its meetings and shall make such rules and regulations for the conduct of its business as it shall deem advisable.
3.6
Designation of Consultants/Liability
. (a) The Committee may, in its sole discretion and to the extent permitted by applicable law and applicable exchange rules, designate employees of the Company and professional advisors to assist the Committee in the administration of the Plan and may grant authority to officers to grant Awards and/or execute agreements or other documents on behalf of the Committee.
(b) The Committee may, in its sole discretion, employ such legal counsel, consultants and agents as it may deem desirable for the administration of the Plan and may rely upon any opinion received from any such counsel or consultant and any computation received from any such consultant or agent. Expenses incurred by the Committee or the Board in the engagement of any such counsel, consultant or agent shall be paid by the Company. The Committee, its members and any person designated pursuant to this
Section 3.6
shall not be liable for any action or determination made in good faith with respect to the Plan. To the maximum extent permitted by applicable law, no officer of the Company or member or former member of the Committee or of the Board shall be liable for any action or determination made in good faith with respect to the Plan or any Award granted under it.
3.7
Indemnification
. To the maximum extent permitted by applicable law and the Certificate of Incorporation and By-Laws of the Company and to the extent not covered by insurance directly insuring such person, each officer or employee of the Company or any Affiliate and member or former member of the Committee or the Board shall be indemnified and held harmless by the Company against any cost or expense (including reasonable fees of counsel reasonably acceptable to the Committee) or liability (including any sum paid in settlement of a claim with the approval of the Committee), and advanced amounts necessary to pay the foregoing at the earliest time and to the fullest extent permitted, arising out of any act or omission to act in connection with the administration of the Plan, except to the extent arising out of such officer’s, employee’s, member’s or former member’s own fraud or bad faith. Such indemnification shall be in addition to any rights of indemnification the employees, officers,
directors or members or former officers, directors or members may have under applicable law or under the Certificate of Incorporation or By -Laws of the Company or any Affiliate. Notwithstanding anything else herein, this indemnification will not apply to the actions or determinations made by an individual with regard to Awards granted to him or her under the Plan.
ARTICLE IV
SHARE LIMITATIONS
4.1
General Limitations
. The aggregate number of shares of Common Stock that may be
issued or used for reference purposes under the Plan or with respect to which Awards may be granted under the Plan shall not exceed 19,620 shares (subject to any increase or decrease pursuant to
Section
4.2
), which may be either authorized and unissued Common Stock or Common Stock held in or acquired
for the treasury of the Company or both. If any Award granted under the Plan expires, terminates, is canceled or is forfeited for any reason, the number of shares of Common Stock underlying such Award shall again be available for the purposes of Awards under the Plan; provided that the Committee may designate any Award to be forfeited to any Person other than the Company, in which case such number of shares of Common Stock underlying such Award shall not be available for the purposes of Awards under the Plan. To the extent that a distribution pursuant to an Award is made in cash, the share reserve shall be reduced by the number of shares of Common Stock bearing a value equal to the amount of the cash distribution as of the time that such amount was determined.
(a)
The existence of the Plan and the Awards granted hereunder shall not affect in any way the right or power of the Board or the stockholders of the Company to make or authorize
(i) any adjustment, recapitalization, reorganization or other change in the Company’s capital structure or its business, (ii) any merger or consolidation of the Company or any Affiliate, (iii) any issuance of bonds, debentures, preferred or prior preference stock ahead of or affecting the Common Stock, (iv) the dissolution or liquidation of the Company or any Affiliate, (v) any sale or transfer of all or part of the assets or business of the Company or any Affiliate, (vi) any Section 4.2 Event or Other Extraordinary Event, or (vii) any other corporate act or proceeding.
(b)
Subject to the provisions of
Section 4.2(d)
, if there shall occur any change in the capital structure of the Company by reason of any stock split, reverse stock split, stock dividend, subdivision, combination or reclassification of shares that may be issued under the Plan, any recapitalization, any merger, any consolidation, any spin off, any reorganization or any partial or complete liquidation, or any other corporate transaction or event having an effect similar to any of the foregoing (a “
Section 4.2 Event
”), then the Committee, in its sole discretion, may adjust (i) the aggregate number and/or kind of shares that thereafter may be issued under the Plan, (ii) the number and/or kind of shares or other property (including cash) to be issued upon exercise of an outstanding Award or under other Awards granted under the Plan and/or (iii) the purchase price thereof. In addition, subject to
Section 4.2(d)
, if there shall occur any change in the capital structure or the business of the Company that is not a Section 4.2 Event (an “
Other
Extraordinary Event
”), including, without limitation, by reason of any extraordinary dividend
(whether cash or stock), any conversion, any adjustment, any issuance of any class of securities convertible or exercisable into, or exercisable for, any class of stock, or any sale or transfer of all or substantially all the Company’s assets or business, then the Committee, in its sole discretion, may adjust any Award and make such other adjustments to the Plan as it may deem appropriate. Any adjustment pursuant to this
Section 4.2
shall be consistent with the applicable Section 4.2 Event or the applicable Other Extraordinary Event, as the case may be, and in such manner as the
Committee may, in its sole discretion, deem appropriate and equitable to prevent substantial dilution or enlargement of the rights granted to, or available for, Participants under the Plan. Any such adjustment determined by the Committee shall be final, binding and conclusive on the Company and all Participants and their respective heirs, executors, administrators, successors and permitted assigns. In connection with any Section 4.2 Event, the Committee may provide, in its sole discretion, for the cancellation of any outstanding Awards and payment in cash or other property in exchange therefor. Except as expressly provided in this
Section 4.2
or in the applicable Award agreement, a Participant shall have no rights by reason of any Section 4.2 Event or any Other Extraordinary Event.
Notwithstanding the foregoing, all adjustments contemplated in this
Section 4.2
shall be effected in a manner intended to comply with Section 409A of the Code to the extent required under Section 409A of the Code.
(c)
Fractional shares of Common Stock resulting from any adjustment in Awards pursuant to
Section 4.2(a) or (b)
shall be eliminated at the time of such adjustment by rounding-down for any fractional shares. No fractional shares of Common Stock shall be issued under the Plan. Notice of any adjustment shall be given by the Committee to each Participant whose Award has been adjusted and such adjustment (whether or not such notice is given) shall be effective and binding for all purposes of the Plan.
(d)
In the event of an Acquisition Event, the Committee may, in its sole discretion, terminate all outstanding and unexercised Stock Options or any Other Stock Based Award that provides for a Participant elected exercise (“
Exercisable Awards
”), effective as of the date of the Acquisition Event, by delivering notice of termination to each Participant at least 20 days prior to the date of consummation of the Acquisition Event, in which case during the period from the date on which such notice of termination is delivered to the consummation of the Acquisition Event, each such Participant shall have the right to exercise his or her Exercisable Awards that are then outstanding to the extent vested as of the date on which such notice of termination is delivered (or, at the discretion of the Committee, without regard to any limitations on exercisability otherwise contained in the Award agreements), but any such exercise shall be contingent upon and subject to the occurrence of the Acquisition Event, and, provided that, if the Acquisition Event does not take place within a specified period after giving such notice for any reason whatsoever, the notice and exercise pursuant thereto shall be null and void. If the Acquisition Event does take place after giving such notice, any Exercisable Award not exercised prior to the date of the consummation of such Acquisition Event shall be forfeited simultaneous with the consummation of the Acquisition Event. For the avoidance of doubt, in the event of an Acquisition Event, the Committee may, in its sole discretion, terminate any Exercisable Award for which the exercise price is equal to or exceeds the Fair Market Value without payment of consideration therefor. If an Acquisition Event occurs but the Committee does not terminate the outstanding Exercisable Awards pursuant to this
Section 4.2(d)
, then the applicable provisions of
Section 4.2(b)
and
Article X
shall apply.
4.3
Minimum Purchase Price
. Notwithstanding any provision of the Plan to the contrary, if
authorized but previously unissued shares of Common Stock are issued under the Plan, such shares shall not be issued for a consideration that is less than as permitted under applicable law.
ARTICLE V
ELIGIBILITY AND GENERAL REQUIREMENTS FOR AWARDS
5.1
General Eligibility
. All Eligible Employees, Non-Employee Directors and Consultants
and prospective Eligible Employees, Consultants and Non-Employee Directors are eligible to be granted Non-Qualified Stock Options, Restricted Stock and Other Stock-Based Awards. Eligibility for the grant of Awards and actual participation in the Plan shall be determined by the Committee in its sole discretion.
5.2
Incentive Stock Options
. Notwithstanding anything herein to the contrary, only Eligible
Employees of the Company, its Subsidiaries and its Parent (if any) are eligible to be granted Incentive Stock Options under the Plan. Eligibility for the grant of an Incentive Stock Option and actual participation in the Plan shall be determined by the Committee in its sole discretion.
5.3
General Requirement
. The granting, vesting and exercise of Awards granted to a
prospective Eligible Employee, Consultant or Non-Employee Director are conditioned upon such individual actually becoming an Eligible Employee, Consultant or Non-Employee Director, provided that no Award may be granted to a prospective Eligible Employee, Consultant or Non-Employee Director unless the Company determines that the Award will comply with applicable laws, including the securities laws of all relevant jurisdictions.
ARTICLE VI
STOCK OPTIONS
6.1
Stock Options
. Each Stock Option granted under the Plan shall be one of two types: (a)
an Incentive Stock Option or (b) a Non-Qualified Stock Option.
6.2
Grants
. The Committee shall, in its sole discretion, have the authority to grant to any
Eligible Employee (subject to
Section 5.2
) Incentive Stock Options, Non-Qualified Stock Options or both types of Stock Options. To the extent that any Stock Option does not qualify as an Incentive Stock Option (whether because of its provisions or the time or manner of its exercise or otherwise), such Stock Option or the portion thereof that does not qualify, shall constitute a separate Non-Qualified Stock Option. The Committee shall, in its sole discretion, have the authority to grant any Consultant or Non-Employee Director one or more Non-Qualified Stock Options.
6.3
Terms of Stock Options
. Stock Options granted under the Plan shall be subject to the
following terms and conditions, and shall be in such form and contain such additional terms and conditions, not inconsistent with the terms of the Plan, as the Committee, in its sole discretion, shall deem desirable:
(a)
Exercise Price.
The exercise price per share of Common Stock subject to a
Stock Option shall be determined by the Committee at the time of grant, provided that the per share exercise price of a Stock Option shall not be less than 100% (or, in the case of an Incentive Stock Option granted to a Ten Percent Stockholder, 110%) of the Fair Market Value of the Common Stock at the time of grant.
(b)
Stock Option Term.
The term of each Stock Option shall be fixed by the
Committee; provided, that (i) no Stock Option shall be exercisable more than 10 years after the date such Stock Option is granted; and (ii) the term of an Incentive Stock Option granted to a Ten Percent Stockholder shall not exceed five years.
(c)
Exercisability.
Stock Options shall be exercisable at such time or times and
subject to such terms and conditions as shall be determined by the Committee at the time of grant. If the Committee provides, in its discretion, that any Stock Option is exercisable subject to certain limitations (including, without limitation, that such Stock Option is exercisable only in installments or within certain time periods or upon the attainment of certain financial results or other criteria), the Committee may waive such limitations on the exercisability at any time at or after grant in whole or in part (including, without limitation, waiver of the installment exercise provisions or acceleration of the time at which such Stock Option may be exercised), based on such factors, if any, as the Committee shall determine, in its sole discretion. Unless otherwise determined by the Committee at grant, the Option agreement shall provide that (i) in the event the Participant engages in Detrimental Activity prior to any exercise of the Stock Option, all Stock Options held by the Participant shall thereupon terminate and expire, (ii) as a condition of the exercise of a Stock Option, the Participant shall be required to certify (or shall be deemed to have certified) at the time of exercise in a manner acceptable to the Company that the Participant is in compliance with the terms and conditions of the Plan and that the Participant has not engaged in, and does not intend to engage in, any Detrimental Activity, and (iii) in the event the Participant engages in Detrimental Activity during the one year period commencing on the later of the date the Stock Option is exercised or becomes vested, the Company shall be entitled to recover from the Participant at any time within one year after such exercise or vesting, and the Participant shall pay over to the Company, an amount equal to any gain realized as a result of the exercise (whether at the time of exercise or thereafter). In the event that a written employment agreement between the Company and a Participant provides for a vesting schedule that is more favorable than the vesting schedule provided in the form of Award agreement, the vesting schedule in such employment agreement shall govern, provided that such agreement is in effect on the date of grant and applicable to the specific Award.
(d)
Method of Exercise.
Subject to whatever installment exercise and waiting period
provisions apply under subsection (c) above, to the extent vested, a Stock Option may be exercised in whole or in part at any time and from time to time during the Stock Option term by giving written notice of exercise to the Company specifying the number of shares of Common Stock to be acquired. Such notice shall be accompanied by payment in full of the purchase price as follows: (i) in cash or by check, bank draft or money order payable to the order of the Company; (ii) solely to the extent permitted by applicable law, if the Common Stock is traded on a national securities exchange or quoted on a national quotation system sponsored by the National Association of Securities Dealers, through a procedure whereby the Participant delivers irrevocable instructions to a broker reasonably acceptable to the Committee to deliver promptly to the Company an amount equal to the purchase price, to the extent authorized by the Committee; or (iii) on such other terms and conditions as may be acceptable to the Committee (including, without limitation, the relinquishment of Stock Options or by payment in full or in part in the form of Common Stock owned by the Participant and for which the Participant has good title free and clear of any liens and encumbrances) based on the Fair Market Value of the Common Stock on the payment date as determined by the Committee, in its sole discretion. No shares of Common Stock shall be issued until payment therefor, as provided herein, has been made or provided for.
(e)
Incentive Stock Option Limitations.
To the extent that the aggregate Fair Market
Value (determined as of the time of grant) of the Common Stock with respect to which Incentive Stock Options are exercisable for the first time by an Eligible Employee during any calendar year under the Plan and/or any other stock option plan of the Company, any Subsidiary or any Parent exceeds $100,000, such Options shall be treated as Non-Qualified Stock Options. In addition, if an Eligible Employee does not remain employed by the Company, any Subsidiary or any Parent
at all times from the time an Incentive Stock Option is granted until three months prior to the date of exercise thereof (or such other period as required by applicable law), such Stock Option shall be treated as a Non-Qualified Stock Option. Should any provision of the Plan not be necessary in order for the Stock Options to qualify as Incentive Stock Options, or should any additional provisions be required, the Committee may, in its sole discretion, amend the Plan accordingly, without the necessity of obtaining the approval of the stockholders of the Company.
(f)
Form, Modification, Extension and Renewal of Stock Options.
Subject to the
terms and conditions and within the limitations of the Plan, Stock Options shall be evidenced by such form of agreement or grant as is approved by the Committee, and the Committee may, in its sole discretion, (i) modify, extend or renew outstanding Stock Options granted under the Plan (provided that (x) the rights of a Participant are not reduced or adversely affected without his or her consent and (y) such action does not subject the Stock Options to Section 409A of the Code), and (ii) accept the surrender of outstanding Stock Options (up to the extent not theretofore exercised) and authorize the granting of new Stock Options in substitution therefor (to the extent not theretofore exercised).
(g)
Buyout and Settlement Provisions
. The Committee may at any time offer to buy
out an Option previously granted, based on such terms and conditions as the Committee shall establish and communicate to the Participant at the time that such offer is made.
(h)
Early Exercise
. The Committee may provide that a Stock Option include a
provision whereby the Participant may elect at any time before the Participant’s Termination to exercise the Stock Option as to any part or all of the shares of Common Stock subject to the Stock Option prior to the full vesting of the Stock Option and such shares shall be subject to certain restrictions as determined by the Committee and be treated as Restricted Stock. Any unvested shares of Common Stock so purchased may be subject to a repurchase option in favor of the Company or to any other restriction the Committee, in its sole discretion, determines to be appropriate.
(i)
Other Terms and Conditions.
Stock Options may contain such other provisions,
which shall not be inconsistent with any of the terms of the Plan, as the Committee shall, in its sole discretion, deem appropriate.
ARTICLE VII
RESTRICTED STOCK
7.1
Awards of Restricted Stock
.
(a) Restricted Stock may be issued either alone or in addition to other Awards granted under the Plan. The Committee shall, in its sole discretion, determine the Eligible Employees, Consultants and Non-Employee Directors to whom, and the time or times within which, grants of Restricted Stock will be made, the number of shares to be awarded, the purchase price (if any) to be paid by the Participant (subject to
Section 7.2
), the time or times at which such Awards may be subject to forfeiture (if any), the vesting schedule (if any) and rights to acceleration thereof, and all other terms and conditions of the Awards. The Committee may condition the grant or vesting of Restricted Stock upon the attainment of specified performance targets or such other factors as the Committee may determine, in its sole discretion.
Unless otherwise determined by the Committee at grant, each Award of Restricted Stock shall provide that in the event the Participant engages in Detrimental Activity prior to, or during the one-year period after, any vesting of Restricted Stock, the Committee may direct that all unvested Restricted Stock shall be immediately forfeited to the Company or any other Person designated by the Committee at any time and that the Participant shall pay over to the Company an amount equal to the Fair Market Value at the time of vesting of any Restricted Stock that had vested in the period referred to above.
(b) The Participant shall not be permitted to Transfer shares of Restricted Stock awarded under the Plan during a period set by the Committee (if any) (the “
Restriction Period
”) commencing with the date of such Award, as set forth in the applicable Award agreement and such agreement shall set forth a vesting schedule and any events that would accelerate vesting of the shares of Restricted Stock. Within these limits, based on service, attainment of any performance goals and/or such other factors or criteria as the Committee may determine in its sole discretion, the Committee may condition the grant or provide for the lapse of such restrictions in installments in whole or in part, or may accelerate the vesting of all or any part of any Restricted Stock Award.
7.2
Awards and Certificates
. An Eligible Employee, Consultant and Non-Employee Director selected to receive Restricted Stock shall not have any rights with respect to such Award, unless and until such Participant has delivered a fully executed copy of the Award agreement evidencing the Award to the Company and has otherwise complied with the applicable terms and conditions of such Award. Further, such Award shall be subject to the following conditions:
(a)
Purchase Price
. The purchase price (if any) of Restricted Stock shall be determined by the Committee, but shall not be less than as permitted under applicable law.
(b)
Acceptance
. Awards of Restricted Stock must be accepted within a period of 60
days (or such shorter period as the Committee may specify at grant) after the grant date, by executing an Award agreement and by paying whatever price (if any) the Committee has designated thereunder and all applicable withholding taxes due upon the granting and acceptance of the Award (if any) in accordance with the provisions of
Section 14.4
.
(c)
Legend
. Each Participant receiving Restricted Stock shall be issued a stock
certificate in respect of such shares of Restricted Stock, unless the Committee elects to use another system, such as book entries by the transfer agent, as evidencing ownership of Restricted Stock. Such certificate shall be registered in the name of such Participant, and shall bear an appropriate legend referring to the terms, conditions, and restrictions applicable to such Award, substantially in the following form:
“The anticipation, alienation, attachment, sale, transfer, assignment, pledge, encumbrance or charge of the shares of stock represented hereby are subject to the terms and conditions (including forfeiture) of the Tigercat Pharma, Inc. (the “
Company
”) 2011 Stock Incentive Plan (as the same may be amended or supplemented from time to time), and an Award agreement entered into between the registered owner and the Company dated ____________. Copies of such Plan and Award agreement are on file at the principal office of the Company.”
(d)
Custody
. The Committee may require that any stock certificates evidencing such shares be held in custody by the Company until the restrictions thereon shall have lapsed, and that, as a condition of any grant of Restricted Stock, the Participant shall have delivered a duly signed stock power, endorsed in blank, relating to the Common Stock covered by such Award.
(e)
Rights as Stockholder
. Except as provided in this subsection and subsection (d) above and as otherwise determined by the Committee, the Participant shall have, with respect to the shares of Restricted Stock, all of the rights of a holder of shares of Common Stock of the Company including, without limitation, the right to receive any dividends, the right to vote such shares and, subject to and conditioned upon the full vesting of shares of Restricted Stock, the right to tender such shares. Notwithstanding the foregoing, the payment of dividends shall be deferred until, and conditioned upon, the expiration of the applicable Restriction Period, unless the Committee, in its sole discretion, specifies otherwise at the time of the Award.
ARTICLE VIII
OTHER STOCK-BASED AWARDS
8.1
Other Awards
. Other Stock-Based Awards may be granted either alone or in addition to
or other Awards granted under the Plan to all eligible Participants pursuant to
Article V
. Subject to the provisions of the Plan, the Committee shall have authority to determine the Eligible Employees, Consultants and Non-Employee Directors to whom, and the time or times at which, Other Stock-Based Awards shall be made, the number of shares of Common Stock to be awarded pursuant to such Awards, and all other conditions of the Awards. The Committee may also provide for the grant of Common Stock under such Awards upon the completion of a specified performance period.
8.2
Terms and Conditions
. Other Stock-Based Awards made pursuant to this
Article VIII
shall be subject to the following terms and conditions:
(a)
Dividends
. Unless otherwise determined by the Committee at the time of award,
subject to the provisions of the Award agreement or grant letter and the Plan, the recipient of an Award under this
Article VIII
shall be entitled to receive, currently or on a deferred basis, dividends or dividend equivalents with respect to the number of shares of Common Stock covered by the Award, as determined at the time of the Award by the Committee, in its sole discretion.
(b)
Vesting
. Any Award under this
Article VIII
and any Common Stock covered by
any such Award shall vest or be forfeited to the extent so provided in the Award agreement, as determined by the Committee, in its sole discretion. In the event that a written employment agreement between the Company and a Participant provides for a vesting schedule that is more favorable than the vesting schedule provided in the form of Award agreement, the vesting schedule in such employment agreement shall govern, provided that such agreement is in effect on the date of grant and applicable to the specific Award.
(c)
Waiver of Limitation
. The Committee may, in its sole discretion, waive in whole
or in part any or all of the limitations imposed hereunder (if any) with respect to all or any portion of an Award under this
Article VIII
.
(d)
Price
. Common Stock or Other Stock-Based Awards issued on a bonus basis
under this
Article VIII
may be issued for no cash consideration; Common Stock or Other Stock-Based Awards purchased pursuant to a purchase right awarded under this
Article VIII
shall be priced as determined by the Committee. Subject to
Section 4.3
, the purchase price of shares of Common Stock or Other Stock-Based Awards may be zero to the extent permitted by applicable law, and, to the extent not so permitted, such purchase price may not be less than par value. The purchase of shares of Common Stock or Other Stock-Based Awards may be made on either an after-tax or pre-tax basis, as determined by the Committee; provided, however, that if the
purchase is made on a pre-tax basis, such purchase shall be made pursuant to a deferred compensation program established by the Committee, which will be deemed a part of the Plan.
(e)
Payment
. The form of payment for the Other Stock-Based Awards shall be specified in the Award agreement.
ARTICLE IX
NON-TRANSFERABILITY AND TERMINATION OF
EMPLOYMENT/CONSULTANCY/DIRECTORSHIP
(a)
Except as otherwise specifically provided herein, no Stock Option shall be Transferable by the Participant otherwise than by will or by the laws of descent and distribution. All Stock Options shall be exercisable, during the Participant’s lifetime, only by the Participant. Shares of Restricted Stock or Other Stock-Based Awards may not be Transferred prior to the date on which shares are issued, or if later, the date on which any applicable restriction, performance or deferral period lapses. Any attempt to Transfer any such Award or share of Common Stock not in accordance with the provisions of
Section 13.2
shall be void and immediately cancelled, and no Award shall in any manner be liable for or subject to the debts, contracts, liabilities, engagements or torts of any person who shall be entitled to such Award, nor shall it be subject to attachment or legal process for or against such person.
(b)
Notwithstanding the foregoing, the Committee may determine, in its sole discretion, at the time of grant or thereafter that a Non-Qualified Stock Option that is otherwise not Transferable pursuant to this
Section 9.1
is Transferable to a Family Member in whole or in part and in such circumstances, and under such conditions, as specified by the Committee. A Non-Qualified Stock Option that is Transferred to a Family Member pursuant to the preceding sentence (i) may not be subsequently Transferred otherwise than by will or by the laws of descent and distribution and (ii) remains subject to the terms of the Plan and the Stock Option agreement. Any shares of Common Stock acquired upon the exercise of a Stock Option by a Permissible Transferee of a Stock Option or a Permissible Transferee pursuant to a Transfer after the exercise of the Stock Option shall be subject to the terms of the Plan and the Stock Option agreement, including, without limitation, the provisions of
Article XIII
.
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9.2
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Termination
. The following rules apply with regard to the Termination of a Participant.
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(a)
Rules Applicable to Stock Options.
Unless otherwise determined by the Committee at grant or, if no rights of the Participant are reduced, thereafter:
(i)
Termination by Reason of Death or Disability.
If a Participant’s Termination is
by reason of death or Disability, all Stock Options that are held by such Participant that are vested and exercisable at the time of the Participant’s Termination may be exercised by the Participant (or, in the case of death, by the legal representative of the Participant’s estate) at any time within a period of one year from the date of such Termination, but in no event beyond the expiration of the stated term of such Stock Options.
(ii)
Involuntary Termination Without Cause.
If a Participant’s Termination is by
involuntary termination without Cause, all Stock Options that are held by such Participant that are vested and exercisable at the time of the Participant’s Termination may be exercised by the
Participant at any time within a period of 90 days from the date of such Termination, but in no event beyond the expiration of the stated term of such Stock Options.
(iii)
Voluntary Termination.
If a Participant’s Termination is voluntary (other than a
voluntary termination described in
Section 9.2(a)(iv)(2)
), all Stock Options that are held by such Participant that are vested and exercisable at the time of the Participant’s Termination may be exercised by the Participant at any time within a period of 30 days from the date of such Termination, but in no event beyond the expiration of the stated terms of such Stock Options.
(iv)
Termination for Cause.
If a Participant’s Termination: (1) is for Cause or (2) is a
voluntary Termination (as provided in subsection (iii) above) after the occurrence of an event that would be grounds for a Termination for Cause, all Stock Options, whether vested or not vested, that are held by such Participant shall thereupon terminate and expire as of the date of such Termination.
(v)
Unvested Stock Options.
Stock Options that are not vested as of the date of a
Participant’s Termination for any reason shall terminate and expire as of the date of such Termination.
(b)
Rules Applicable to Restricted Stock and Other Stock-Based Awards
. Unless otherwise determined by the Committee at grant or, thereafter, upon a Participant’s Termination for any reason:
(i) during the relevant Restriction Period, all Restricted Stock still subject to restriction shall be forfeited; and (ii) any unvested Other Stock-Based Awards shall be forfeited.
ARTICLE X
CHANGE IN CONTROL
Except as otherwise provided by the Committee in an Award agreement, in the event of a Change in Control of the Company after the Effective Date, the Committee may, but shall not be obligated to:
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(a)
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accelerate, vest or cause the restrictions to lapse with respect to all or any portion
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of an Award; or
(b)
cancel Awards for fair value (as determined in good faith by the Committee) which, in the case of Options, may equal the excess, if any, of the value of the consideration to be paid in the Change in Control transaction to holders of the same number of shares of Common Stock subject to such Options (or, if no consideration is paid in any such transaction, the Fair Market Value of the shares of Common Stock subject to such Options) over the aggregate exercise price of such Options; or
(c)
provide for the issuance of substitute Awards that will substantially preserve the otherwise applicable terms of any affected Awards previously granted hereunder as determined by the Committee in its sole discretion.
ARTICLE XI
TERMINATION OR AMENDMENT OF PLAN
Notwithstanding any other provision of the Plan, the Board or the Committee may at any time, and from time to time, amend, in whole or in part, any or all of the provisions of the Plan (including any
amendment deemed necessary to ensure that the Company may comply with any regulatory requirement referred to in
Article XIV
or Section 409A of the Code as described below), or suspend or terminate it entirely, retroactively or otherwise; provided, however, that if the Committee, in its sole discretion, determines that the rights of a Participant with respect to Awards granted prior to such amendment, suspension or termination, may be adversely impaired, the consent of such Participant shall be required; and provided further, only to the extent stockholder approval is required, without the approval of the stockholders of the Company entitled to vote in accordance with applicable law, no amendment may be made that would:
(a)
increase the aggregate number of shares of Common Stock that may be issued under the Plan (other than due to an adjustment under
Section 4.2
);
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(b)
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change the classification of individuals eligible to receive Awards under the Plan;
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(c)
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decrease the minimum exercise price of any Stock Option;
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(d)
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extend the maximum Stock Option period under
Section 6.3
; or
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(e)
require stockholder approval in order for the Plan to continue to comply with Section 422 of the Code to the extent applicable to Incentive Stock Options or the rules of any exchange or system on which the Company’s securities are listed or traded at the request of the Company.
The Committee may amend the terms of any Award theretofore granted, prospectively or retroactively, but, subject to
Article IV
or as otherwise specifically provided herein, no such amendment or other action by the Committee shall adversely impair the rights of any holder without the holder’s consent. Notwithstanding anything herein to the contrary, the Board or the Committee may amend the Plan or any Award granted hereunder at any time without a Participant’s consent to comply with Section 409A of the Code or any other applicable law. Nothing in the Plan is intended to provide a guarantee of particular tax treatment to any Participant.
ARTICLE XII
UNFUNDED PLAN
The Plan is an “unfunded” plan for incentive and deferred compensation. With respect to any payments as to which a Participant has a fixed and vested interest but that are not yet made to a Participant by the Company, nothing contained herein shall give any such Participant any rights that are greater than those of a general unsecured creditor of the Company.
ARTICLE XIII
COMPANY CALL RIGHTS; RIGHTS OF FIRST REFUSAL;
APPROVED SALE
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13.1
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Company Call Rights
.
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(a)
In the event of a Participant’s Termination for Cause or a Participant’s voluntary Termination within 90 days after the occurrence of an event that would be grounds for a Termination for Cause or the discovery that a Participant engaged in Detrimental Activity, the Company may at any time repurchase (or may cause its designee to repurchase) from the
Participant (or his or her transferee) any shares of Common Stock previously acquired by the Participant through the exercise of a Stock Option or pursuant to Other Stock-Based Awards granted under the Plan at a repurchase price equal to the lesser of (A) the book value, if any, (B) the original purchase price or exercise price (as applicable), if any or (C) the Fair Market Value of a share of Common Stock on the date of Termination or the date of repurchase, as selected by the Committee.
(b)
In the event of a Participant’s Termination for Cause or a Participant’s voluntary Termination within 90 days after the occurrence of an event that would be grounds for a Termination for Cause or the discovery that a Participant engaged in Detrimental Activity, the Company may repurchase (or may cause its designee to repurchase) from the Participant (or his or her transferee) any shares of Common Stock previously acquired by the Participant pursuant to Restricted Stock granted under the Plan at a repurchase price equal to the lesser of (A) the book value, if any, (B) the Fair Market Value of a share of Common Stock on the date of grant or (C) the Fair Market Value of a share of Common Stock on the date of Termination or the date of repurchase, as selected by the Committee.
(c)
In the event of a Termination for any reason other than for Cause (including Termination due to death, Disability, involuntary termination without Cause or resignation), the Company may at any time within the later of one year after (i) a Participant incurs a Termination or (ii) the date a Participant acquires shares of Common Stock upon the exercise of a Stock Option following his or her Termination for any reason other than for Cause: (A) repurchase (or may cause its designee to purchase) from the Participant the outstanding vested portion of the Option based on the difference between the exercise price of a share of Common Stock relating to such Stock Option and the Fair Market Value of a share of Common Stock on the date of repurchase and (B) repurchase from the Participant any shares of Common Stock previously acquired by the Participant through the exercise of a Stock Option, which solely to the extent necessary to avoid adverse accounting consequences for the Company, have been held by a Participant for at least six months and one day (or such other period necessary to avoid such a charge) at a repurchase price equal to the Fair Market Value on the date of repurchase.
(d)
In the event of a Termination for any reason other than for Cause (including Termination due to death, Disability, involuntary termination without Cause or resignation), the Company may at any time within one year after a Participant incurs a Termination other than for Cause repurchase (or may cause its designee to purchase) from the Participant any shares of Common Stock previously acquired by the Participant pursuant to Restricted Stock or Other Stock-Based Awards under the Plan, which solely to the extent necessary to avoid adverse accounting consequences for the Company, have been held by a Participant for at least six months and one day (or such other period necessary to avoid such a charge), at a repurchase price equal to Fair Market Value on the date of repurchase.
(e)
(i) If the Company elects to exercise call rights under this
Section 13.1
, it shall do so by delivering to the Participant a notice of such election, specifying the number of shares to be purchased and the closing date and time that, solely for purposes of subsections (c) and (d), is within the applicable one year period. Such closing shall take place at the Company’s principal executive offices.
(ii)
At such closing, the Company will pay the Participant the repurchase price as specified in this
Section 13.1
in cash, or by cancellation of indebtedness of the Participant to the Company.
13.2
Transfer Limit
.
(a)
Restrictions on Transfer.
No Participant shall, directly or indirectly, prior to the
Registration Date or such other date determined by the Committee, Transfer any shares of Common Stock acquired through the exercise of a Stock Option or pursuant to Restricted Stock or Other Stock-Based Award under the Plan prior to the Participant’s Termination and expiration of the time period provided in
Sections 13.1(a) through (d)
hereof (the “
Transfer Restriction
Period
”). Notwithstanding the foregoing, the Participant shall have the right to Transfer such
shares of Common Stock to a Permissible Transferee who takes the shares subject to the terms of the Plan and applicable Award agreement provided that such Transfer shall not be effective unless and until the Company shall have been furnished with information reasonably satisfactory to it demonstrating that such Transfer is exempt from or not subject to the provisions of Section 5 of the Securities Act and any other applicable securities laws.
(b)
Right of First Refusal
. After the Transfer Restriction Period, no Participant shall
Transfer any Common Stock acquired through the exercise of a Stock Option or pursuant to a Restricted Stock or Other Stock-Based Award under the Plan to any Person other than a Permissible Transferee unless in each such instance the Participant (or his or her estate or legal representative) shall have first offered to the Company the Common Stock proposed to be Transferred pursuant to a bona fide offer to a third party.
(c)
Notice of Proposed Transfer.
Prior to any proposed Transfer of the Common
Stock acquired through the exercise of a Stock Option or pursuant to a Restricted Stock or Other Stock-Based Award under the Plan, the Participant shall give a written notice (the “
Transfer
Notice
”) to the Company describing fully the proposed Transfer, including the number of shares
of Common Stock, the name and address of the proposed Transferee (the “
Proposed
Transferee
”) and, if the Transfer is voluntary, the proposed Transfer price, and containing such
information necessary to show that the Participant has obtained a bona fide binding offer to Transfer the Common Stock for cash from a third party. The Participant shall provide a separate Transfer Notice with regard to each Proposed Transferee. The Transfer Notice shall be signed by both the Participant and the Proposed Transferee and must constitute a binding and unconditional commitment of the Participant and the Proposed Transferee for the Transfer of the Common Stock to the Proposed Transferee for cash subject only to the right of first refusal specified herein.
(d)
Bona Fide Transfer.
If the Company determines that the information provided
by the Participant in the Transfer Notice is insufficient to establish the bona fide nature of a proposed voluntary Transfer, the Company shall give the Participant written notice of the Participant’s failure to comply with the procedure described herein, and the Participant shall have no right to Transfer the Common Stock without first complying with this procedure. The Participant shall not be permitted to Transfer the Common Stock if the proposed Transfer is not bona fide.
(e)
Exercise of Right of First Refusal
. If the Company determines the proposed
Transfer to be a bona fide Transfer, VPH shall have the right to repurchase all or any part of the shares of Common Stock at the proposed Transfer price per share, by delivering to the Participant (or his or her estate or legal representative) written notice of such exercise within 30 days after the date the Company has determined that the proposed Transfer is bona fide. VPH’s exercise or failure to exercise the right of first refusal with respect to any proposed Transfer described in a Transfer Notice shall not affect VPH’s right to exercise the right of first refusal with respect to any proposed Transfer described in any other Transfer Notice, whether or not such other Transfer Notice is issued by the Participant or issued by a person other than the Participant with respect to
a proposed Transfer to the same Proposed Transferee. If VPH exercises the right of first refusal, VPH and the Participant shall thereupon consummate the sale of the Common Stock to VPH within five days after the date VPH has decided to exercise the right of first refusal described herein (unless a longer period is offered by the Proposed Transferee).
(f)
Failure to Exercise Right of First Refusal.
If VPH fails to exercise the right of
first refusal with respect to any share of Common Stock within the period specified in subsection
(e)
above, and the Company has not given notice to the Participant that the proposed Transfer is not a bona fide Transfer pursuant to subsection (d) above, the Participant may conclude a Transfer to the Proposed Transferee of the Common Stock on the terms and conditions described in the Transfer Notice, provided such Transfer occurs not later than five days after the date VPH has determined not to exercise the right of first refusal described herein. The Company shall have the right to demand further assurances from the Participant and the Proposed Transferee (in a form satisfactory to the Company) that the Transfer of the Common Stock was actually carried out on the terms and conditions described in the Transfer Notice. No Common Stock shall be transferred on the books of the Company until the Company has received such assurances, if so demanded, and has approved the proposed Transfer as bona fide. Any proposed Transfer on terms and conditions different from those described in the Transfer Notice, as well as any subsequent proposed Transfer by the Participant (or his or her estate or legal representative), shall again be subject to the right of first refusal and shall require compliance by the Participant with the procedure described in this
Section 13.2
.
(g)
Assignment of Right of First Refusal.
VPH shall have the right to assign the right
of first refusal at any time, whether or not there has been an attempted Transfer, to one or more persons as may be selected by VPH, from time to time.
(h)
Application to Transferees.
This
Section 13.2
shall apply to any Permissible
Transferee in the same manner as it applies to a Participant.
13.3
Alternative Call Rights, Rights of First Refusal and Other Rights
. The Committee may
provide in the applicable Award agreement alternative (or no) call rights and/or rights of first refusal and/or other rights at the time of grant (or, thereafter, if no rights of the Participant are reduced) as it may decide in its sole discretion. Notwithstanding anything herein to the contrary, if a Participant executes a stockholder’s agreement (or similar agreement) that provides call rights and/or rights of first refusal or rights of first offer, the provisions in the stockholder’s agreement (or similar agreement) shall control to the extent they are inconsistent with this
Article XIII
.
13.4
Approved Sale
.
(a)
If the Board and stockholders having the requisite voting power at law and under the Company’s governing documents (including, without limitation, the Stockholders’ Agreement) approve a sale of all or substantially all of the assets of the Company or a sale of all (or, for accounting, tax or other reasons, substantially all) of the outstanding shares of Common Stock (whether by merger, recapitalization, consolidation, reorganization, combination or otherwise) to an independent third party or group of independent third parties or any other action constituting a Liquidation Event (as such term is defined in the Company’s certificate of incorporation from time to time) (each such sale or Liquidation Event, an "
Approved Sale
"), then each holder of shares of Common Stock issued pursuant to an Award under this Plan (“
Issued
Shares
”) will vote for, consent to and raise no objections against such Approved Sale. If the
Approved Sale is structured as (i) a merger or consolidation, each holder of Issued Shares will waive any dissenters' rights, appraisal rights or similar rights in connection with such merger or
consolidation or (ii) a sale of stock, each holder of Issued Shares will agree to sell all of his or her Issued Shares on the terms and conditions approved by the holders of a majority of the shares of voting Common Stock then outstanding. Each holder of Issued Shares or Options, as applicable, will take all necessary or desirable actions in connection with the consummation of the Approved Sale as reasonably requested by the Company including, without limitation, executing any applicable purchase agreement and, if necessary, exercising any Options. Each holder of Issued Shares, upon execution of the applicable option agreement, irrevocably constitutes and appoints the Company the true and lawful attorney of such holder, with full power of substitution, in the name of such holder or the Company to give effect to this
Section 13.4
, including the execution of any documentation necessary to transfer ownership of Issued Shares pursuant to an Approved Sale. Each holder of Issued Shares, upon execution of the applicable option agreement, agrees that the powers granted to the Company in the immediately preceding sentence are coupled with an interest and are irrevocable by any holder of Issued Shares.
(b) If the Company or the holders of the Company's securities enter into any negotiation or transaction for which Rule 506 (or any similar rule then in effect) promulgated by the Securities and Exchange Commission may be available with respect to such negotiation or transaction (including a merger, consolidation or other reorganization), the holders of Issued Shares will, at the request of the Company, appoint a purchaser representative (as such term is defined in Rule 501) reasonably acceptable to the Company. If any holder of Issued Shares appoints a purchaser representative designated by the Company, the Company will pay the fees of such purchaser representative, but if any holder of Issued Shares declines to appoint the purchaser representative reasonably designated by the Company, such holder will appoint another purchaser representative, and such holder will be responsible for the fees of the purchaser representative so appointed.
(c)
In the event of an Approved Sale, each Participant and all shares of Common Stock of the Participant covered by an Award shall, except to the extent otherwise determined by the Board, be subject to substantially the same escrow, indemnification and similar obligations, contingencies and encumbrances contained in the definitive agreement relating to the Approved Sale as holders of Common Stock may be subject (including, without limitation, the requirement to contribute a proportionate amount of the shares of Common Stock (or any cash or property that may be received upon exercise or exchange of an Award) to an escrow fund, or otherwise have a proportionate amount of the shares of Common Stock (or any cash or property that may be received upon exercise or exchange of an Award) encumbered by the indemnification, escrow and similar provisions of such definitive agreement). By accepting an Award, a Participant agrees to execute such documents and instruments as the Board may reasonably require for the Participant to be bound by such obligations. In the event that a Participant fails or refuses to execute such documents and instruments, his or her Award shall be canceled and be of no further force and effect, upon the consummation of an Approved Sale, unless (i) otherwise determined by the Board, or (ii) such Award was previously exercised for Issued Shares to the extent exercisable.
(d)
Each holder of Issued Shares will bear their pro rata share (based upon the amount of consideration received) of the costs of any sale of Issued Shares pursuant to an Approved Sale to the extent such costs are incurred for the benefit of all holders of Common Stock and are not otherwise paid by the Company or the acquiring party. Costs incurred by any holder of Issued Shares on his or her own behalf will not be considered costs of the transaction hereunder.
13.5
Effect of Registration
. Notwithstanding the foregoing, unless otherwise determined by the Committee, the Company shall cease to have rights pursuant to this
Article XIII
on and after the Registration Date.
ARTICLE XIV
GENERAL PROVISIONS
14.1
Legend
. The Committee may require each person receiving shares of Common Stock pursuant to an Award granted under the Plan to represent to and agree with the Company in writing that the Participant is acquiring the shares without a view to distribution thereof and such other securities law related representations as the Committee shall request. In addition to any legend required by the Plan, the certificates and/or book entry accounts for such shares may include any legend that the Committee, in its sole discretion, deems appropriate to reflect any restrictions on Transfer.
All certificates and/or book entry accounts for shares of Common Stock delivered under the Plan shall be subject to such stop transfer orders and other restrictions as the Committee may, in its sole discretion, deem advisable under the rules, regulations and other requirements of the Securities and Exchange Commission, any stock exchange upon which the Common Stock is then listed or any national automated quotation system on which the Common Stock is then quoted, any applicable Federal or state securities law, and any applicable corporate law, and the Committee may cause a legend or legends to be put on any such certificates to make appropriate reference to such restrictions.
14.2
Other Plans
. Nothing contained in the Plan shall prevent the Board from adopting other
or additional compensation arrangements, subject to stockholder approval if such approval is required; and such arrangements may be either generally applicable or applicable only in specific cases.
14.3
No Right to Employment/Consultancy/Directorship
. Neither the Plan nor the grant of
any Award hereunder shall give any Participant or other employee, Consultant or Non-Employee Director any right with respect to continuance of employment, consultancy or directorship by the Company or any Affiliate, nor shall they be a limitation in any way on the right of the Company or any Affiliate by which an employee is employed or a Consultant or Non-Employee Director is retained to terminate his or her employment, consultancy or directorship at any time.
14.4
Withholding of Taxes
. The Company or an Affiliate shall have the right to deduct from
any payment to be made to a Participant, or to otherwise require, prior to the issuance or delivery of any shares of Common Stock or the payment of any cash hereunder, payment by the Participant of, any Federal, state or local taxes required by law to be withheld. Upon the vesting of Restricted Stock (or other Award that is taxable upon vesting), or upon making an election under Section 83(b) of the Code, a Participant shall pay all required withholding to the Company or an Affiliate, as directed by the Committee. Any statutorily required withholding obligation with regard to any Eligible Employee may be satisfied, subject to the advanced consent of the Committee, by reducing the number of shares of Common Stock otherwise deliverable or by delivering shares of Common Stock already owned. Any fraction of a share of Common Stock required to satisfy such tax obligations shall be disregarded and the amount due shall be paid instead in cash by the Participant.
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14.5
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Listing and Other Conditions
.
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(a)
Unless otherwise determined by the Committee, as long as the Common Stock is listed on a national securities exchange or system sponsored by a national securities association, the issue of any shares of Common Stock pursuant to an Award shall be conditioned upon such
shares being listed on such exchange or system. The Company shall have no obligation to issue such shares unless and until such shares are so listed, and the right to exercise any Award with respect to such shares shall be suspended until such listing has been effected.
(b)
If at any time counsel to the Company shall be of the opinion that any sale or delivery of shares of Common Stock pursuant to an Award is or may in the circumstances be unlawful or result in the imposition of excise taxes on the Company under the statutes, rules or regulations of any applicable jurisdiction, the Company shall have no obligation to make such sale or delivery, or to make any application or to effect or to maintain any qualification or registration under the Securities Act or otherwise with respect to shares of Common Stock or Awards, and the right to exercise any Award shall be suspended until, in the opinion of said counsel, such sale or delivery shall be lawful and will not result in the imposition of excise taxes on the Company.
(c)
Upon termination of any period of suspension under this
Section 14.5
, an Award affected by such suspension that shall not then have expired or terminated shall be reinstated as to all shares available before such suspension and as to shares that would otherwise have become available during the period of such suspension, but no such suspension shall extend the term of any Award.
(d)
A Participant shall be required to supply the Company with any certificates, representations and information that the Company requests and otherwise cooperate with the Company in obtaining any listing, registration, qualification, exemption, consent or approval the Company deems necessary or appropriate.
14.6
Stockholders Agreement and Other Requirements
. Notwithstanding anything herein to
the contrary, as a condition to the receipt of shares of Common Stock pursuant to an Award granted under the Plan, the Participant shall execute and deliver, to the extent required by the Committee, a stockholder’s agreement or such other documentation which shall set forth certain restrictions on transferability of the shares of Common Stock acquired upon exercise or purchase, a right of first refusal of the Company with respect to shares, and such other terms or restrictions as the Board or Committee shall from time to time establish. Such stockholder’s agreement or other documentation shall apply to the Common Stock acquired under the Plan and covered by such stockholder’s agreement or other documentation. The Company may require, as a condition of exercise, the Participant to become a party to any other existing stockholder’s agreement or other agreement.
14.7
Governing Law
. The Plan and the actions taken in connection herewith shall be
governed and construed in accordance with the laws of the State of Delaware (regardless of the law that might otherwise govern under applicable Delaware principles of conflict of laws).
14.8
Construction
. Wherever any words are used in the Plan in the masculine gender they
shall be construed as though they were also used in the feminine gender in all cases where they would so apply, and wherever any words are used herein in the singular form they shall be construed as though they were also used in the plural form in all cases where they would so apply.
14.9
Other Benefits
. No Award granted or paid out under the Plan shall be deemed
compensation for purposes of computing benefits under any retirement plan of the Company or its Affiliates nor affect any benefits under any other benefit plan now or subsequently in effect under which the availability or amount of benefits is related to the level of compensation.
14.10
Costs
. The Company shall bear all expenses associated with administering the Plan,
including expenses of issuing Common Stock pursuant to any Award granted hereunder.
14.11
No Right to Same Benefits
. The provisions of Awards need not be the same with respect
to each Participant, and Awards granted to individual Participants need not be the same.
14.12
Death/Disability
. The Committee may in its sole discretion require the transferee of a
Participant to supply it with written notice of the Participant’s death or Disability and to supply it with a copy of the will (in the case of the Participant’s death) or such other evidence as the Committee deems necessary to establish the validity of the transfer of an Award. The Committee may, in its sole discretion, also require the agreement of the transferee to be bound by all of the terms and conditions of the Plan.
14.13
Severability of Provisions
. If any provision of the Plan shall be held invalid or
unenforceable, such invalidity or unenforceability shall not affect any other provisions hereof, and the Plan shall be construed and enforced as if such provisions had not been included; provided, however, that if the Company’s call rights and rights of first refusal set forth in
Article XIII
shall be held invalid or unenforceable, the Awards granted under the Plan shall be cancelled and terminated.
14.14
Headings and Captions
. The headings and captions herein are provided for reference and
convenience only, shall not be considered part of the Plan, and shall not be employed in the construction of the Plan.
14.15
Securities Act Compliance
. Except as the Company or Committee shall otherwise
determine, the Plan is intended to comply with Section 4(2) or Rule 701 of the Securities Act, and any provisions inconsistent with such Section or Rule of the Securities Act shall be inoperative and shall not affect the validity of the Plan.
14.16
Successors and Assigns
. The Plan shall be binding on all successors and permitted
assigns of a Participant, including, without limitation, the estate of such Participant and the executor, administrator or trustee of such estate.
14.17
Payment to Minors, Etc.
Any benefit payable to or for the benefit of a minor, an
incompetent person or other person incapable of receipt thereof shall be deemed paid when paid to such person’s guardian or to the party providing or reasonably appearing to provide for the care of such person, and such payment shall fully discharge the Committee, the Board, the Company, its Affiliates and their employees, agents and representatives with respect thereto.
14.18
Agreement
. As a condition to the grant of an Award, if requested by the Company and
the lead underwriter of any public offering of the Common Stock (the “
Lead Underwriter
”), a Participant shall irrevocably agree not to sell, contract to sell, grant any option to purchase, transfer the economic risk of ownership in, make any short sale of, pledge or otherwise transfer or dispose of, any interest in any Common Stock or any securities convertible into, derivative of, or exchangeable or exercisable for, or any other rights to purchase or acquire Common Stock (except Common Stock included in such public offering or acquired on the public market after such offering) during such period of time following the effective date of a registration statement of the Company filed under the Securities Act that the Lead Underwriter shall specify (the “
Lock-up Period
”). The Participant shall further agree to sign such documents as may be requested by the Lead Underwriter to effect the foregoing and agree that the Company may impose stop-transfer instructions with respect to Common Stock acquired pursuant to an Award until the end of such Lock-up Period.
14.19
No Rights as Stockholder
. Except as provided in
Article VII
with respect to Restricted
Stock or
Article VIII
with respect to Other Stock-Based Awards, subject to the provisions of the Award agreement, no Participant or Permissible Transferee shall have any rights as a stockholder of the Company with respect to any Award until such individual becomes the holder of record of the shares of Common Stock underlying the Award.
14.20
Section 409A of the Code
. To the extent applicable, the Plan is intended to comply with
the applicable requirements of Section 409A of the Code and shall be limited, construed and interpreted in accordance with such intent. To the extent that any Award is subject to Section 409A of the Code, it shall be paid in a manner that will comply with Section 409A of the Code, including proposed, temporary or final regulations or any other guidance issued by the Secretary of the Treasury and the Internal Revenue Service with respect thereto. Notwithstanding anything herein to the contrary, any provision in the Plan that is inconsistent with Section 409A of the Code shall be deemed to be amended to comply with Section 409A of the Code and to the extent such provision cannot be amended to comply therewith, such provision shall be null and void.
14.21
Consideration
. Awards may be awarded in consideration for past services actually
rendered to the Company or an Affiliate for its benefit; provided, however, that in the case of an Award to be made to a new Eligible Employee, Non-Employee Director, or Consultant who has not performed prior services for the Company, the Company will require payment of the par value of the Common Stock by cash or check in order to ensure proper issuance of the shares in compliance with Delaware General Corporation Law.
ARTICLE XV
EFFECTIVE DATE OF PLAN
The Plan shall become effective upon adoption by the Board or such later date as provided in the adopting resolution, subject to the approval of the Plan by the stockholders of the Company within 12 months before or after adoption of the Plan by the Board.
ARTICLE XVI
TERM OF PLAN
No Award shall be granted pursuant to the Plan on or after the tenth anniversary of the earlier of the date the Plan is adopted by the Board and the date of stockholder approval, but Awards granted prior to such tenth anniversary may, and the Committee’s authority to administer the terms of such Awards shall, extend beyond that date.
Exhibit 10.4(b)
EXECUTION VERSION
AMENDMENT TO
TIGERCAT PHARMA, INC.
___________________________
2011 STOCK INCENTIVE PLAN
____________________________
The Tigercat Pharma, Inc. 2011 Stock Incentive Plan, as amended, is hereby amended as follows, effective February 13, 2017:
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1.
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The first sentence of Section 4.1 is hereby deleted in its entirety and replaced with the following:
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“The aggregate number of shares of Common Stock that may be issued or used for reference purposes under the Plan or with respect to which Awards may be granted under the Plan shall not exceed 6,663,905 shares (subject to any increase or decrease pursuant to Section 4.2), which may be either authorized and unissued Common Stock or Common Stock held in or acquired for the treasury of the Company or both.”
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2.
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The following shall apply to all existing and future Awards:
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a.
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Notwithstanding anything to the contrary in the Plan or an Award agreement, each Award that, at the time of an Acquisition Event, is scheduled to vest and, if applicable, become exercisable, on or after the twelve (12) month anniversary of such Acquisition Event (ignoring, for this purpose, any accelerated vesting provisions) shall instead vest and, if applicable, become exercisable on the date of such twelve (12) month anniversary, subject to the absence of a Termination with respect to the holder of such Award as of the date of such twelve (12) month anniversary.
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b.
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Notwithstanding anything to the contrary in the Plan or an Award agreement, each Award shall vest and, if applicable, become exercisable, with respect to one hundred (100%) of the unvested shares of Common Stock covered thereby, and the post-termination exercise period for such Award shall be twelve (12) months from the date of Termination (or, if earlier, the expiration of the stated term thereof) if, in connection with or during the twelve (12) month period following an Acquisition Event, the Participant holding such Award incurs a Termination of service as the result of (a) an involuntary termination by the Company without Cause or (b) a voluntary termination of service by the Participant for Good Reason, in each case provided that the Participant executes a general release of claims in favor of the Company. For this purpose, “Good Reason” means, with respect to a Termination of a Participant’s service by the Participant, that such Termination is for “Good Reason” as such term (or word of like import) is expressly defined in a then-effective written agreement between such Participant and the Company or an Affiliate, or in the absence of such then-effective written agreement and definition, means the occurrence of any of the following events or conditions unless consented to by such Participant (and such Participant shall be deemed to have consented to any such event or condition unless such Participant provides written notice of such Participant’s non-acquiescence within thirty (30) days of the effective time of such event or condition): (i) a change in such Participant’s responsibilities or duties which represents a material and substantial diminution in such Participant’s responsibilities; (ii) a material reduction in such Participant’s base salary; provided that an across-the-board reduction in the salary level of substantially all other individuals in positions similar to such Participant’s by the same percentage amount shall not constitute such a salary reduction; or (iii) requiring such Participant to be based at any place outside a fifty (50) mile radius from such Participant’s job location or residence except for reasonably required travel on business.
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3.
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Except as modified by this Amendment, all of the terms and conditions of the Plan shall remain valid and in full force and effect.
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TIGERCAT PHARMA, INC. 2011 STOCK INCENTIVE PLAN
NOTICE OF STOCK OPTION AWARD
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Participant’s Name and Address:
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You (the “Participant”) have been granted an option to purchase shares of Common Stock, subject to the terms and conditions of this Notice of Stock Option Award (the “Notice”), the Tigercat Pharma, Inc., 2011 Stock Incentive Plan, as amended from time to time (the “Plan”) and the Stock Option Award Agreement (the “Option Agreement”) attached hereto, as follows. Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Notice.
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Date of Award
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Vesting Commencement Date
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Exercise Price per Share
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$
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Total Number of Shares Subject
to the Option (the “Shares”)
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Total Exercise Price
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$
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Type of Option:
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Incentive Stock Option
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Non-Qualified Stock Option
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Expiration Date:
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Vesting Schedule
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Subject to the absence of a Termination and other limitations set forth in this Notice, the Plan and the Option Agreement, the Option may be exercised, in whole or in part, in accordance with the following schedule:
[INSERT VESTING SCHEDULE – FOR EXAMPLE: 25% of the Shares subject to the Option shall vest twelve (12) months after the Vesting Commencement Date, and 1/36 of the remaining unvested Shares subject to the Option shall vest on each of the next thirty-six (36) monthly anniversaries of the Vesting Commencement Date thereafter.]
IN WITNESS WHEREOF, the Company and the Participant have executed this Notice and agree that the Option is to be governed by the terms and conditions of this Notice, the Plan, and the Option Agreement.
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Tigercat Pharma, Inc.,
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a Delaware corporation
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By:
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Title:
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THE PARTICIPANT ACKNOWLEDGES AND AGREES THAT THE SHARES SUBJECT TO THE OPTION SHALL VEST, IF AT ALL, ONLY DURING THE PERIOD OF THE PARTICIPANT’S SERVICE (NOT THROUGH THE ACT OF BEING HIRED, BEING GRANTED THE OPTION OR ACQUIRING SHARES HEREUNDER). THE PARTICIPANT FURTHER ACKNOWLEDGES AND AGREES THAT NOTHING IN THIS NOTICE, THE OPTION AGREEMENT, OR THE PLAN SHALL CONFER UPON THE PARTICIPANT ANY RIGHT WITH RESPECT TO FUTURE AWARDS OR CONTINUATION OF THE PARTICIPANT’S SERVICE, NOR SHALL IT INTERFERE IN ANY WAY WITH THE PARTICIPANT’S RIGHT OR THE RIGHT OF THE COMPANY OR AN AFFILIATE OF THE COMPANY TO WHICH THE PARTICIPANT PROVIDES SERVICES TO TERMINATE THE PARTICIPANT’S SERVICE, WITH OR WITHOUT CAUSE, AND WITH OR WITHOUT NOTICE
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THE PARTICIPANT ACKNOWLEDGES THAT UNLESS THE PARTICIPANT HAS A WRITTEN EMPLOYMENT AGREEMENT WITH THE COMPANY TO THE CONTRARY, THE PARTICIPANT’S STATUS IS AT WILL.
The Participant acknowledges receipt of a copy of the Plan and the Option Agreement, and represents that he or she is familiar with the terms and provisions thereof, and hereby accepts the Option subject to all of the terms and provisions hereof and thereof. The Participant has reviewed this Notice, the Plan, and the Option Agreement in their entirety, has had an opportunity to obtain the advice of counsel prior to executing this Notice, and fully understands all provisions of this Notice, the Plan and the Option Agreement. The Participant hereby agrees that all questions of interpretation and administration relating to this Notice, the Plan and the Option Agreement shall be resolved by the Committee in accordance with Section 21 of the Option Agreement. The Participant further agrees to the venue selection in accordance with Section 22 of the Option Agreement. The Participant further agrees to notify the Company upon any change in the residence address indicated in this Notice.
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Dated:
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Signed:
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Participant
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TIGERCAT PHARMA, INC. 2011 STOCK INCENTIVE PLAN
STOCK OPTION AWARD AGREEMENT
1.
Grant of Option
. Tigercat Pharma, Inc., a Delaware corporation (the “Company”), hereby grants to the Participant (the “Participant”) named in the Notice of Stock Option Award (the “Notice”), an option (the “Option”) to purchase the Total Number of Shares of Common Stock subject to the Option (the “Shares”) set forth in the Notice, at the Exercise Price per Share set forth in the Notice (the “Exercise Price”) subject to the terms and provisions of the Notice, this Stock Option Award Agreement (the “Option Agreement”) and the Company’s 2011 Stock
Incentive Plan, as amended from time to time (the “Plan”), which are incorporated herein by reference. Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Option Agreement.
If designated in the Notice as an Incentive Stock Option, the Option is intended to qualify as an Incentive Stock Option as defined in Section 422 of the Code. However, notwithstanding such designation, the Option will qualify as an Incentive Stock Option under the Code only to the extent the $100,000 dollar limitation of Section 422(d) of the Code is not exceeded. The $100,000 limitation of Section 422(d) of the Code is calculated based on the aggregate Fair Market Value of the Shares subject to options designated as Incentive Stock Options which become exercisable for the first time by the Participant during any calendar year (under all plans of the Company or any Parent or Subsidiary of the Company). For purposes of this calculation, Incentive Stock Options shall be taken into account in the order in which they were granted, and the Fair Market Value of the shares subject to such options shall be determined as of the grant date of the relevant option.
2.
Exercise of Option
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(a)
Right to Exercise
. The Option shall be exercisable during its term in accordance with the Vesting Schedule set out in the Notice and with the applicable provisions of the Plan and this Option Agreement. The Option shall be subject to the provisions of the Plan relating to the exercisability or termination of the Option in the event of an Acquisition Event (as set forth in the Plan) or Change in Control (as set forth in the Plan). The Participant shall be subject to reasonable limitations on the number of requested exercises during any monthly or weekly period as determined by the Committee. In no event shall the Company issue fractional Shares.
(b)
Method of Exercise
. The Option shall be exercisable as set forth in Section 6.3(d) of the Plan and by delivery of an exercise notice (a form of which is attached as Exhibit A) or by such other procedure as specified from time to time by the Committee which shall state the election to exercise the Option, the whole number of Shares in respect of which the Option is being exercised, and such other provisions as may be required by the Committee. The exercise notice shall be delivered in person, by certified mail, or by such other method (including electronic transmission) as determined from time to time by the Committee to the Company accompanied by payment of the Exercise Price and all applicable income and employment taxes
required to be withheld. The Option shall be deemed to be exercised upon receipt by the Company of such notice accompanied by the Exercise Price and all applicable withholding taxes.
(c)
Taxes
. No Shares will be delivered to the Participant or other person pursuant to the exercise of the Option until the Participant or other person has made arrangements acceptable to the Committee for the satisfaction of applicable income tax and employment tax withholding obligations, including, without limitation, such other tax obligations of the Participant incident to the receipt of Shares. Upon exercise of the Option, the Company or the Participant’s employer may offset or withhold (from any amount owed by the Company or the Participant’s employer to the Participant) or collect from the Participant or other person an amount sufficient to satisfy such tax withholding obligations. Furthermore, in the event of any determination that the Company has failed to withhold a sum sufficient to pay all withholding taxes due in connection with the Option, the Participant agrees to pay the Company the amount of such deficiency in cash within five (5) days after receiving a written demand from the Company to do so, whether or not the Participant is an employee of the Company at that time.
3.
Participant’s Representations
. The Participant understands that neither the Option nor the Shares exercisable pursuant to the Option have been registered under the Securities Act of 1933, as amended or any United States securities laws. In the event the Shares purchasable pursuant to the exercise of the Option have not been registered under the Securities Act of 1933, as amended, at the time the Option is exercised, the Participant shall, if requested by the Company, concurrently with the exercise of all or any portion of the Option, deliver to the Company his or her Investment Representation Statement in the form attached hereto as Exhibit B.
4.
Method of Payment
. Payment of the Exercise Price shall be made as set forth in Section 6.3(d) of the Plan.
5.
Restrictions on Exercise
. The Option may not be exercised if the issuance of the Shares subject to the Option upon such
exercise would constitute a violation of any applicable laws. If the exercise of the Option within the applicable time periods set forth in Section 6 of this Option Agreement is prevented by the provisions of this Section 5, the Option shall remain exercisable until one (1) month after the date the Participant is notified by the Company that the Option is exercisable, but in any event no later than the Expiration Date set forth in the Notice.
6.
Termination
. In the event of the Participant’s Termination, the Option shall be subject to the provisions of Section 9.2(a)(i) through (v) of the Plan.
7.
Reserved
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8.
Reserved
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9.
Transferability of Option
. The Option shall be Transferable as set forth in Section 9.1 of the Plan. Notwithstanding the foregoing, if a Non-Qualified Stock Option, the Option is Transferable to a Family Member in whole or in part and in such circumstances, and under such
conditions, as specified by the Committee. A Non-Qualified Stock Option that is Transferred to a Family Member pursuant to the preceding sentence (i) may not be subsequently Transferred otherwise than by will or by the laws of descent and distribution and (ii) remains subject to the terms of the Plan and the Option Agreement. Any shares of Common Stock acquired upon the exercise of the Option by a Permissible Transferee of the Option or a Permissible Transferee pursuant to a Transfer after the exercise of the Option shall be subject to the terms of the Plan and the Option Agreement.
10.
Term of Option
. The Option must be exercised no later than the Expiration Date set forth in the Notice or such earlier date as otherwise provided herein. After the Expiration Date or such earlier date, the Option shall be of no further force or effect and may not be exercised.
11.
Company’s Right of First Refusal
. The Participant acknowledges and agrees that the Shares are subject to a right of first refusal (“Right of First Refusal”) as set forth in the Bylaws of the Company, which Right of First Refusal is incorporated herein by reference irrespective of whether the Bylaws are amended at some future date to remove the Right of First Refusal therefrom, and that, except in compliance with such Right of First Refusal, neither the Participant nor a transferee (either being sometimes referred to herein as the “Holder”) shall sell, hypothecate, encumber or otherwise transfer any Shares or any right or interest therein.”
12.
Company Call Rights; Transfer Limits
. The Option and any vested shares of Common Stock previously acquired by the Participant through the exercise of the Option shall be subject to the provisions of Section 13.1 and Section 13.2 of the Plan (the “Transfer Restrictions”).
13.
Escrow of Stock
. For purposes of facilitating the enforcement of the provisions of this Option Agreement, the Participant agrees, immediately upon receipt of the certificate(s) for the Shares, to deliver such certificate(s), together with an Assignment Separate from Certificate in the form attached hereto as Exhibit C, executed in blank by the Participant with respect to each such stock certificate, to the Secretary or Assistant Secretary of the Company, or their designee, to hold in escrow for so long as such Shares are subject to Transfer Restrictions or the Right of First Refusal (“Restricted Shares”), with the authority to take all such actions and to effectuate all such transfers and/or releases as may be necessary or appropriate to accomplish the objectives of this Option Agreement in accordance with the terms hereof. The Participant hereby acknowledges that the appointment of the Secretary or Assistant Secretary of the Company (or their designee) as the escrow holder hereunder with the stated authorities is a material inducement to the Company to make this Option Agreement and that such appointment is coupled with an interest and is accordingly irrevocable. The Participant agrees that the Restricted Shares may be held electronically in a book entry system maintained by the Company’s transfer agent or other third-party and that all the terms and conditions of this Section 13 applicable to certificated Restricted Shares will apply with the same force and effect to such electronic method for holding the Restricted Shares. The Participant agrees that such escrow holder shall not be liable to any party hereto (or to any other party) for any actions or omissions unless such escrow holder is grossly negligent relative thereto. The escrow holder may rely upon
any letter, notice or other document executed by any signature purported to be genuine and may resign at any time. Subject to the provisions of any security agreement relating to Participant’s purchase of the Shares, upon the vesting of Shares and termination of the Transfer Restrictions, the escrow holder will, upon request, transmit to the Participant the certificate evidencing such Shares.
14.
Additional Securities
. Any securities or cash received (other than a regular cash dividend) as the result of ownership of the Shares (the “Additional Securities”), including, but not by way of limitation, warrants, options and securities received as a stock dividend or stock split, or as a result of any transaction described in Section
4.2(b) of the Plan, shall be subject to the same conditions and restrictions as the Shares with respect to which they were issued. The Participant shall be entitled to direct the Company to exercise any warrant or option received as Additional Securities upon supplying the funds necessary to do so, in which event the securities so purchased shall constitute Additional Securities, but the Participant may not direct the Company to sell any such warrant or option. If Additional Securities consist of a convertible security, the Participant may exercise any conversion right, and any securities so acquired shall constitute Additional Securities. Appropriate adjustments to reflect the distribution of Additional Securities shall be made to the price per share to be paid upon the exercise of the Company Call Rights provided for in Section 13.1 of the Plan or the Repurchase Right in order to reflect the effect of any such transaction upon the Company’s capital structure. In the event of any change in certificates evidencing the Shares or the Additional Securities by reason of any recapitalization, reorganization or other transaction that results in the creation of Additional Securities, the escrow holder is authorized to deliver to the issuer the certificates evidencing the Shares or the Additional Securities in exchange for the certificates of the replacement securities.
15.
Stop‑Transfer Notices
. In order to ensure compliance with the restrictions on transfer set forth in this Option Agreement, the Notice or the Plan, the Company may issue appropriate “stop transfer” instructions to its transfer agent, if any, and, if the Company transfers its own securities, it may make appropriate notations to the same effect in its own records.
16.
Refusal to Transfer
. The Company shall not be required (i) to transfer on its books any Shares that have been sold or otherwise transferred in violation of any of the provisions of this Option Agreement or (ii) to treat as owner of such Shares or to accord the right to vote or pay dividends to any purchaser or other transferee to whom such Shares shall have been so transferred.
17.
Tax Consequences.
(a)
The Participant may incur tax liability as a result of the Participant’s purchase or disposition of the Shares. THE PARTICIPANT SHOULD CONSULT A TAX ADVISER BEFORE EXERCISING THE OPTION OR DISPOSING OF THE SHARES.
(b)
Notwithstanding the Company’s good faith determination of the Fair Market Value of the Company’s Common Stock for purposes of determining the Exercise Price Per Share of the Option as set forth in the Notice, the taxing authorities may assert that the Fair Market Value of the Common Stock on the Date of Award was greater than the Exercise Price
Per Share. If designated in the Notice as an Incentive Stock Option, the Option may fail to qualify as an Incentive Stock Option if the Exercise Price Per Share of the Option is less than the Fair Market Value of the Common Stock on the Date of Award. In addition, under Section 409A of the Code, if the Exercise Price Per Share of the Option is less than the Fair Market Value of the Common Stock on the Date of Award, the Option may be treated as a form of deferred compensation and the Participant may be subject to an acceleration of income recognition, an additional 20% tax, plus interest and possible penalties. In addition, the Company makes no representation that the Option will comply with Section 409A of the Code and makes no undertaking to prevent Section 409A of the Code from applying to the Option or to mitigate its effects on any deferrals or payments made in respect of the Option. The Participant is encouraged to consult a tax adviser regarding the potential impact of Section 409A of the Code.
18.
Lock-Up Agreement
. The Shares are subject to the “lock-up” provisions of Section 14.18 of the Plan.
19.
Entire Agreement: Governing Law
. The Notice, the Plan and this Option Agreement constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and the Participant with respect to the subject matter hereof, and may not be modified adversely to the Participant’s interest except by means of a writing signed by the Company and the Participant. Nothing in the Notice, the Plan and this Option Agreement (except as expressly provided therein) is intended to confer any rights or remedies on any persons other than the parties. The Notice, the Plan and this Option Agreement are to be construed in accordance with and governed by the internal laws of the
State of California without giving effect to any choice of law rule that would cause the application of the laws of any jurisdiction other than the internal laws of the State of California or the rights and duties of the parties. Should any provision of the Notice, the Plan or this Option Agreement be determined to be illegal or unenforceable, such provision shall be enforced to the fullest extent allowed by law and the other provisions shall nevertheless remain effective and shall remain enforceable.
20.
Construction
. The captions used in the Notice and this Option Agreement are inserted for convenience and shall not be deemed a part of the Option for construction or interpretation. Except when otherwise indicated by the context, the singular shall include the plural and the plural shall include the singular. Use of the term “or” is not intended to be exclusive, unless the context clearly requires otherwise.
21.
Administration and Interpretation
. Any question or dispute regarding the administration or interpretation of the Notice, the Plan or this Option Agreement shall be submitted by the Participant or by the Company to the Committee. The resolution of such question or dispute by the Committee shall be final and binding on all persons.
22.
Venue
. The Company, the Participant, and the Participant’s assignees pursuant to Section 9 (the “parties”) agree that any suit, action, or proceeding arising out of or relating to the Notice, the Plan or this Option Agreement shall be brought in the United States District Court for the Northern District of California (or should such court lack jurisdiction to hear such action, suit or proceeding, in a California state court in the County of San Francisco) and that the parties
shall submit to the jurisdiction of such court. The parties irrevocably waive, to the fullest extent permitted by law, any objection the party may have to the laying of venue for any such suit, action or proceeding brought in such court. If any one or more provisions of this Section 22 shall for any reason be held invalid or unenforceable, it is the specific intent of the parties that such provisions shall be modified to the minimum extent necessary to make it or its application valid and enforceable.
23.
Confidentiality
. To the extent required by applicable law, the Company shall provide to the Participant, during the period the Option is outstanding, copies of financial statements of the Company at least annually. The Participant understands and agrees that such financial statements are confidential and shall not be disclosed by the Participant, to any entity or person, for any reason, at any time, without the prior written consent of the Company, unless required by law. If disclosure of such financial statements is required by law, whether through subpoena, request for production, deposition, or otherwise, the Participant promptly shall provide written notice to Company, including copies of the subpoena, request for production, deposition, or otherwise, within five (5) business days of their receipt by the Participant and prior to any disclosure so as to provide Company an opportunity to move to quash or otherwise to oppose the disclosure. Notwithstanding the foregoing, the Participant may disclose the terms of such financial statements to his or her spouse or domestic partner, and for legitimate business reasons, to legal, financial, and tax advisors.
24.
Notices
. Any notice required or permitted hereunder shall be given in writing and shall be deemed effectively given upon personal delivery, upon deposit for delivery by an internationally recognized express mail courier service or upon deposit in the United States mail by certified mail (if the parties are within the United States), with postage and fees prepaid, addressed to the other party at its address as shown in these instruments, or to such other address as such party may designate in writing from time to time to the other party.
END OF AGREEMENT
EXHIBIT A
TIGERCAT PHARMA, INC. 2011 STOCK INCENTIVE PLAN
EXERCISE NOTICE
Tigercat Pharma, Inc.
400 Oyster Point Boulevard, Suite 202
South San Francisco, CA 94080
Attention: Secretary
1.
Effective as of today, ______________, ___ the undersigned (the “Participant”) hereby elects to exercise the Participant’s option to purchase ___________ shares of the Common Stock (the “Shares”) of ________________, Inc. (the “Company”) under and pursuant to the Company’s 2011Stock Incentive Plan, as amended from time to time (the “Plan”) and the [ ] Incentive [ ] Non-Qualified Stock Option Award Agreement (the “Option Agreement”) and Notice of Stock Option Award (the “Notice”) dated ______________, ________. Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Exercise Notice.
2.
Representations of the Participant
. The Participant acknowledges that the Participant has received, read and understood the Notice, the Plan and the Option Agreement and agrees to abide by and be bound by their terms and conditions.
3.
Rights as Shareholder
. Until the stock certificate evidencing such Shares is issued (as evidenced by the appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company), no right to vote or receive dividends or any other rights as a shareholder shall exist with respect to the Shares, notwithstanding the exercise of the Option. The Company shall issue (or cause to be issued) such stock certificate promptly after the Option is exercised. No adjustment will be made for a dividend or other right for which the record date is prior to the date the stock certificate is issued, except as provided in Section 14.5 of the Plan.
The Participant shall enjoy rights as a shareholder until such time as the Participant disposes of the Shares or the Company and/or its assignee(s) exercises its rights under Section 13 of the Plan or the Repurchase Right. Upon such exercise, the Participant shall have no further rights as a holder of the Shares so purchased except the right to receive payment for the Shares so purchased in accordance with the provisions of the Option Agreement, and the Participant shall forthwith cause the certificate(s) evidencing the Shares so purchased to be surrendered to the Company for transfer or cancellation.
4.
Delivery of Payment
. The Participant herewith delivers to the Company the full Exercise Price for the Shares.
5.
Tax Consultation
. The Participant understands that the Participant may suffer adverse tax consequences as a result of the Participant’s purchase or disposition of the Shares. The Participant represents that the Participant has consulted with any tax consultants the
Participant deems advisable in connection with the purchase or disposition of the Shares and that the Participant is not relying on the Company for any tax advice.
6.
Taxes
. The Participant agrees to satisfy all applicable federal, state and local income and employment tax withholding obligations and herewith delivers to the Company the full amount of such obligations or has made arrangements acceptable to the Company to satisfy such obligations. In the case of an Incentive Stock Option, the Participant also agrees, as partial consideration for the designation of the Option as an Incentive Stock Option, to notify the Company in writing within thirty (30) days of any disposition of any shares acquired by exercise of the Option if such disposition occurs within two (2) years from the Date of Award or within one (1) year from the date the Shares were transferred to the Participant.
7.
Restrictive Legends
. The Participant understands and agrees that the Company shall cause the legends set forth below or legends substantially equivalent thereto, to be placed upon any certificate(s) evidencing ownership of the Shares together with any other legends that may be required by the Company or by state or federal securities laws:
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THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 (THE “ACT”) OR ANY STATE SECURITIES LAWS AND MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED UNLESS AND UNTIL REGISTERED UNDER THE ACT OR, IN THE OPINION OF COUNSEL SATISFACTORY TO THE ISSUER OF THESE SECURITIES, SUCH OFFER, SALE OR TRANSFER, PLEDGE OR HYPOTHECATION IS IN COMPLIANCE THEREWITH.
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THE SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO CERTAIN RESTRICTIONS ON TRANSFER, A RIGHT OF FIRST REFUSAL AND REPURCHASE RIGHTS HELD BY THE ISSUER OR ITS ASSIGNEE(S) AS SET FORTH IN THE OPTION AGREEMENT BETWEEN THE ISSUER AND THE ORIGINAL HOLDER OF THESE SHARES, A COPY OF WHICH MAY BE OBTAINED AT THE PRINCIPAL OFFICE OF THE ISSUER. SUCH TRANSFER RESTRICTIONS, RIGHT OF FIRST REFUSAL AND REPURCHASE RIGHTS ARE BINDING ON TRANSFEREES OF THESE SHARES.
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THE ANTICIPATION, ALIENATION, ATTACHMENT, SALE, TRANSFER, ASSIGNMENT, PLEDGE, ENCUMBRANCE OR CHANGE OF THE SHARE OF STOCK REPRESENTED HEREBY ARE SUBJECT TO THE TERMS AND CONDITIONS (INCLUDING FORFEITURE) OF THE TIGERCAT PHARMA, INC. (THE “COMPANY”) 2011 STOCK INCENTIVE PLAN (AS THE SAME MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME), AND AN AWARD AGREEMENT ENTERED INTO BETWEEN THE REGISTERED OWNER AND THE COMPANY. COPIES OF SUCH PLAN AND AWARD AGREEMENT ARE ON FILE AT THE PRINCIPAL OFFICE OF THE COMPANY”
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8.
Successors and Assigns
. The Company may assign any of its rights under this Exercise Notice to single or multiple assignees, and this agreement shall inure to the benefit of the successors and assigns of the Company. Subject to the restrictions on transfer herein set forth, this Exercise Notice shall be binding upon the Participant and his or her heirs, executors, administrators, successors and assigns.
9.
Construction
. The captions used in this Exercise Notice are inserted for convenience and shall not be deemed a part of this agreement for construction or interpretation. Except when otherwise indicated by the context, the singular shall include the plural and the plural shall include the singular. Use of the term “or” is not intended to be exclusive, unless the context clearly requires otherwise.
10.
Administration and Interpretation
. The Participant hereby agrees that any question or dispute regarding the administration or interpretation of this Exercise Notice shall be submitted by the Participant or by the Company to the Committee. The resolution of such question or dispute by the Committee shall be final and binding on all persons.
11.
Governing Law; Severability
. This Exercise Notice is to be construed in accordance with and governed by the internal laws of the State of California without giving effect to any choice of law rule that would cause the application of the laws of any jurisdiction other than the internal laws of the State of California to the rights and duties of the parties. Should any provision of this Exercise Notice be determined by a court of law to be illegal or unenforceable, such provision shall be enforced to the fullest extent allowed by law and the other provisions shall nevertheless remain effective and shall remain enforceable.
12.
Notices
. Any notice required or permitted hereunder shall be given in writing and shall be deemed effectively given upon personal delivery, upon deposit for delivery by an internationally recognized express mail courier service or upon deposit in the United States mail by certified mail (if the parties are within the United States), with postage and fees prepaid, addressed to the other party at its address as shown below beneath its signature, or to such other address as such party may designate in writing from time to time to the other party.
13.
Further Instruments
. The parties agree to execute such further instruments and to take such further action as may be reasonably necessary to carry out the purposes and intent of this agreement.
14.
Entire Agreement
. The Notice, the Plan and the Option Agreement are incorporated herein by reference and together with this Exercise Notice constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and the Participant with respect to the subject matter hereof, and may not be modified adversely to the Participant’s interest except by means of a writing signed by the Company and the Participant. Nothing in the Notice, the Plan, the Option Agreement and this Exercise Notice (except as expressly provided therein) is intended to confer any rights or remedies on any persons other than the parties.
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Submitted by:
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Accepted by:
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PARTICIPANT:
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TIGERCAT PHARMA, INC.
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By:
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Title:
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(Signature)
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Address
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Address
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400 Oyster Point Boulevard, Suite 202
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South San Francisco, CA 94080
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EXHIBIT B
TIGERCAT PHARMA, INC. 2011 STOCK INCENTIVE PLAN
INVESTMENT REPRESENTATION STATEMENT
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PARTICIPANT:
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COMPANY:
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SECURITY:
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COMMON STOCK
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AMOUNT:
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DATE:
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In connection with the purchase of the above‑listed Securities, the undersigned Participant represents to the Company the following:
(a)
Participant is aware of the Company’s business affairs and financial condition and has acquired sufficient information about the Company to reach an informed and knowledgeable decision to acquire the Securities. Participant is acquiring these Securities for investment for Participant’s own account only and not with a view to, or for resale in connection with, any “distribution” thereof within the meaning of the Securities Act of 1933, as amended (the “Securities Act”).
(b)
Participant acknowledges and understands that the Securities constitute “restricted securities” under the Securities Act and have not been registered under the Securities Act in reliance upon a specific exemption therefrom, which exemption depends upon among other things, the bona fide nature of Participant’s investment intent as expressed herein. Participant further understands that the Securities must be held indefinitely unless they are subsequently registered under the Securities Act or an exemption from such registration is available. Participant further acknowledges and understands that the Company is under no obligation to register the Securities. Participant understands that the certificate evidencing the Securities will be imprinted with a legend which prohibits the transfer of the Securities unless they are registered or such registration is not required in the opinion of counsel satisfactory to the Company.
(c)
Participant is familiar with the provisions of Rule 701 and Rule 144, each promulgated under the Securities Act, which, in substance, permit limited public resale of “restricted securities” acquired, directly or indirectly from the issuer thereof, in a non‑public offering subject to the satisfaction of certain conditions. Rule 701 provides that if the issuer qualifies under Rule 701 at the time of the grant of the Option to the Participant, the exercise will be exempt from registration under the Securities Act. In the event the Company becomes subject to the reporting requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, ninety (90) days thereafter (or such longer period as any market stand‑off agreement may require) the Securities exempt under Rule 701 may be resold, except in the case of affiliates, such Securities may be resold subject to the satisfaction of the applicable conditions specified by
Rule 144, including: (1) the availability of certain public information about the Company, (2) the amount of Securities being sold during any three month period not exceeding specified limitations, (3) the resale being made in an unsolicited “broker’s transaction,” in transactions directly with a “market maker” or “riskless principal transactions” (as said terms are defined under the Securities Exchange Act of 1934) and (4) the timely filing of a Form 144, if applicable.
In the event that the Company does not qualify under Rule 701 at the time of sale of the Securities, then the Securities may be resold in certain limited circumstances subject to the provisions of Rule 144, which may require: the availability of current public information about the Company; the resale to occur more than a specified period after the purchase and full payment (within the meaning of Rule 144) for the Securities; and, in the case of the sale of Securities by an affiliate, the satisfaction of the conditions set forth in sections (2), (3) and (4) of the paragraph immediately above.
(d)
Participant further understands that in the event all of the applicable requirements of Rule 701 or 144 are not satisfied, registration under the Securities Act, compliance with Regulation A, or some other registration exemption will be required; and that, notwithstanding the fact that Rules 144 and 701 are not exclusive, the Staff of the Securities and Exchange Commission has expressed its opinion that persons proposing to sell private placement securities other than in a registered offering and otherwise than pursuant to Rules 144 or 701 will have a substantial burden of proof in establishing that an exemption from registration is available for such offers or sales, and that such persons and their respective brokers who participate in such transactions do so at their own risk. Participant understands that no assurances can be given that any such other registration exemption will be available in such event.
(e)
Participant represents that the Participant is a resident of the state of ____________________.
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Signature of Participant:
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Date: ____________________,_____
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EXHIBIT C
STOCK ASSIGNMENT SEPARATE FROM CERTIFICATE
[Please sign this document but do not date it. The date and information of the transferee will be completed if and when the shares are assigned.]
FOR VALUE RECEIVED, ____________________________ hereby sells, assigns and transfers unto _______________________, __________________ (____) shares of the Common Stock of _______________________, Inc., a ________________ corporation (the “Company”), standing in his name on the books of, represented by Certificate No. __ herewith, and does hereby irrevocably constitute and appoint the Secretary of the Company attorney to transfer the said stock in the books of the Company with full power of substitution.
TIGERCAT PHARMA, INC. 2011 STOCK INCENTIVE PLAN
NOTICE OF STOCK OPTION AWARD
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Participant’s Name and Address:
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You (the “Participant”) have been granted an option to purchase shares of Common Stock, subject to the terms and conditions of this Notice of Stock Option Award (the “Notice”), the Tigercat Pharma, Inc., 2011 Stock Incentive Plan, as amended from time to time (the “Plan”) and the Stock Option Award Agreement (the “Option Agreement”) attached hereto, as follows. Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Notice.
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Date of Award
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Vesting Commencement Date
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Exercise Price per Share
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$
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Total Number of Shares Subject
to the Option (the “Shares”)
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Total Exercise Price
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$
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Type of Option:
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Incentive Stock Option
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Non-Qualified Stock Option
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Expiration Date:
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Vesting Schedule
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This Option is immediately exercisable although the Shares issued upon exercise of the Option will be subject to the restrictions on transfer and a right of repurchase at the Exercise Price per Share, in favor of the Company, as described in Section 16
of the Option Agreement (the “Repurchase Right”). For purposes of this Notice and the Option Agreement, the term “vest” shall mean, with respect to any Shares, that such Shares (whether subject to the Option or acquired upon exercise of the Option) are no longer subject to the Repurchase Right as to unvested Shares, provided, however, that such Shares shall remain subject to other restrictions on transfer set forth in the Option Agreement or the Plan. If the Participant would become vested in a fraction of a Share, such Share shall not vest until the Participant becomes vested in the entire Share. Provided that the Participant has not had a Termination any time prior to the applicable vesting date set forth below and subject to the other limitations set forth in this Notice, the Plan and the Option Agreement, the Repurchase Right as to unvested Shares
shall lapse in accordance with the following schedule (the “Vesting Schedule”): [INSERT VESTING SCHEDULE]
IN WITNESS WHEREOF, the Company and the Participant have executed this Notice and agree that the Option is to be governed by the terms and conditions of this Notice, the Plan, and the Option Agreement.
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Tigercat Pharma, Inc.,
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a Delaware corporation
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By:
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Title:
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THE PARTICIPANT ACKNOWLEDGES AND AGREES THAT THE SHARES SUBJECT TO THE OPTION SHALL VEST, IF AT ALL, ONLY DURING THE PERIOD OF THE PARTICIPANT’S SERVICE (NOT THROUGH THE ACT OF BEING HIRED, BEING GRANTED THE OPTION OR ACQUIRING SHARES HEREUNDER). THE PARTICIPANT FURTHER ACKNOWLEDGES AND AGREES THAT NOTHING IN THIS NOTICE, THE OPTION AGREEMENT, OR THE PLAN SHALL CONFER UPON THE PARTICIPANT ANY RIGHT WITH RESPECT TO FUTURE AWARDS OR CONTINUATION OF THE PARTICIPANT’S SERVICE, NOR SHALL IT INTERFERE IN ANY WAY WITH THE PARTICIPANT’S RIGHT OR THE RIGHT OF THE COMPANY OR AN AFFILIATE OF THE COMPANY TO WHICH THE PARTICIPANT PROVIDES SERVICES TO TERMINATE THE PARTICIPANT’S SERVICE, WITH OR WITHOUT CAUSE, AND WITH OR WITHOUT NOTICE
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THE PARTICIPANT ACKNOWLEDGES THAT UNLESS THE PARTICIPANT HAS A WRITTEN EMPLOYMENT AGREEMENT WITH THE COMPANY TO THE CONTRARY, THE PARTICIPANT’S STATUS IS AT WILL.
The Participant acknowledges receipt of a copy of the Plan and the Option Agreement, and represents that he or she is familiar with the terms and provisions thereof, and hereby accepts the Option subject to all of the terms and provisions hereof and thereof. The Participant has reviewed this Notice, the Plan, and the Option Agreement in their entirety, has had an opportunity to obtain the advice of counsel prior to executing this Notice, and fully understands all provisions of this Notice, the Plan and the Option Agreement. The Participant hereby agrees that all questions of interpretation and administration relating to this Notice, the Plan and the Option Agreement shall be resolved by the Committee in accordance with Section 23 of the Option Agreement. The Participant further agrees to the venue selection in accordance with Section 24 of the Option Agreement. The Participant further agrees to notify the Company upon any change in the residence address indicated in this Notice.
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Dated:
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Signed:
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Participant
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TIGERCAT PHARMA, INC. 2011 STOCK INCENTIVE PLAN
IMMEDIATELY EXERCISABLE STOCK OPTION AWARD AGREEMENT
1.
Grant of Option
. Tigercat Pharma, Inc., a Delaware corporation (the “Company”), hereby grants to the Participant (the “Participant”) named in the Notice of Stock Option Award (the “Notice”), an option (the “Option”) to purchase the Total Number of Shares of Common Stock subject to the Option (the “Shares”) set forth in the Notice, at the Exercise Price per Share set forth in the Notice (the “Exercise Price”) subject to the terms and provisions of the Notice, this Stock Option Award Agreement (the “Option Agreement”) and the Company’s 2011 Stock
Incentive Plan, as amended from time to time (the “Plan”), which are incorporated herein by reference. Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Option Agreement.
If designated in the Notice as an Incentive Stock Option, the Option is intended to qualify as an Incentive Stock Option as defined in Section 422 of the Code. However, notwithstanding such designation, the Option will qualify as an Incentive Stock Option under the Code only to the extent the $100,000 dollar limitation of Section 422(d) of the Code is not exceeded. The $100,000 limitation of Section 422(d) of the Code is calculated based on the aggregate Fair Market Value of the Shares subject to options designated as Incentive Stock Options which become exercisable for the first time by the Participant during any calendar year (under all plans of the Company or any Parent or Subsidiary of the Company). For purposes of this calculation, Incentive Stock Options shall be taken into account in the order in which they were granted, and the Fair Market Value of the shares subject to such options shall be determined as of the grant date of the relevant option.
2.
Exercise of Option
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(a)
Right to Exercise
. The Option shall be immediately exercisable during its term in accordance with the applicable provisions of the Plan and this Option Agreement. The Option shall be subject to the provisions of the Plan relating to the exercisability or termination of the Option in the event of an Acquisition Event (as set forth in the Plan) or Change in Control (as set forth in the Plan). The Participant shall be subject to reasonable limitations on the number of requested exercises during any monthly or weekly period as determined by the Committee. In no event shall the Company issue fractional Shares.
(b)
Method of Exercise
. The Option shall be exercisable as set forth in Section 6.3(d) of the Plan and by delivery of an exercise notice (a form of which is attached as Exhibit A) or by such other procedure as specified from time to time by the Committee which shall state the election to exercise the Option, the whole number of Shares in respect of which the Option is being exercised, and such other provisions as may be required by the Committee. The exercise notice shall be delivered in person, by certified mail, or by such other method (including electronic transmission) as determined from time to time by the Committee to the Company accompanied by payment of the Exercise Price and all applicable income and employment taxes required to be withheld. The Option shall be deemed to be exercised upon receipt by the Company of such notice accompanied by the Exercise Price and all applicable withholding taxes.
(c)
Taxes
. No Shares will be delivered to the Participant or other person pursuant to the exercise of the Option until the Participant or other person has made arrangements acceptable to the Committee for the satisfaction of applicable income tax and employment tax withholding obligations, including, without limitation, such other tax obligations of the Participant incident to the receipt of Shares. Upon exercise of the Option, the Company or the Participant’s employer may offset or withhold (from any amount owed by the Company or the Participant’s employer to the Participant) or collect from the Participant or other person an amount sufficient to satisfy such tax withholding obligations. Furthermore, in the event of any determination that the Company has failed to withhold a sum sufficient to pay all withholding taxes due in connection with the Option, the Participant agrees to pay the Company the amount of such deficiency in cash within five (5) days after receiving a written demand from the Company to do so, whether or not the Participant is an employee of the Company at that time.
3.
Participant’s Representations
. The Participant understands that neither the Option nor the Shares exercisable pursuant to the Option have been registered under the Securities Act of 1933, as amended or any United States securities laws. In the event the Shares purchasable pursuant to the exercise of the Option have not been registered under the Securities Act of 1933, as amended, at the time the Option is exercised, the Participant shall, if requested by the Company, concurrently with the exercise of all or any portion of the Option, deliver to the Company his or her Investment Representation Statement in the form attached hereto as Exhibit B.
4.
Method of Payment
. Payment of the Exercise Price shall be made as set forth in Section 6.3(d) of the Plan.
5.
Restrictions on Exercise
. The Option may not be exercised if the issuance of the Shares subject to the Option upon such
exercise would constitute a violation of any applicable laws. If the exercise of the Option within the applicable time periods set forth in Section 6 of this Option Agreement is prevented by the provisions of this Section 5, the Option shall remain exercisable until one (1) month after the date the Participant is notified by the Company that the Option is exercisable, but in any event no later than the Expiration Date set forth in the Notice.
6.
Termination
. In the event of the Participant’s Termination, the Option shall be subject to the provisions of Section 9.2(a)(i) through (v) of the Plan.
7.
Reserved
.
8.
Reserved
.
9.
Transferability of Option
. The Option shall be Transferable as set forth in Section 9.1 of the Plan. Notwithstanding the foregoing, if a Non-Qualified Stock Option, the Option is Transferable to a Family Member in whole or in part and in such circumstances, and under such conditions, as specified by the Committee. A Non-Qualified Stock Option that is Transferred to a Family Member pursuant to the preceding sentence (i) may not be subsequently Transferred otherwise than by will or by the laws of descent and distribution and (ii) remains subject to the
terms of the Plan and the Option Agreement. Any shares of Common Stock acquired upon the exercise of the Option by a Permissible Transferee of the Option or a Permissible Transferee pursuant to a Transfer after the exercise of the Option shall be subject to the terms of the Plan and the Option Agreement.
10.
Term of Option
. The Option must be exercised no later than the Expiration Date set forth in the Notice or such earlier date as otherwise provided herein. After the Expiration Date or such earlier date, the Option shall be of no further force or effect and may not be exercised.
11.
Transfer Restrictions for Unvested Shares
. The Shares sold to the Participant hereunder may not be sold, transferred by gift, pledged, hypothecated, or otherwise transferred or disposed of by the Participant prior to the date that the Shares become vested pursuant to the Vesting Schedule set forth in the Notice. Any attempt to transfer Shares in violation of this Section 11 will be null and void and will be disregarded.
12.
Company Call Rights; Transfer Limits
. The Option and any vested shares of Common Stock previously acquired by the Participant through the exercise of the Option shall be subject to the provisions of Section 13.1 and Section 13.2 of the Plan (the “Transfer Restrictions”).
13.
Escrow of Stock
. For purposes of facilitating the enforcement of the provisions of this Option Agreement, the Participant agrees, immediately upon receipt of the certificate(s) for the Shares, to deliver such certificate(s), together with an Assignment Separate from Certificate in the form attached hereto as Exhibit C, executed in blank by the Participant with respect to each such stock certificate, to the Secretary or Assistant Secretary of the Company, or their designee, to hold in escrow for so long as such Shares are subject to Transfer Restrictions or the Repurchase Right (“Restricted Shares”), with the authority to take all such actions and to effectuate all such transfers and/or releases as may be necessary or appropriate to accomplish the objectives of this Option Agreement in accordance with the terms hereof. The Participant hereby acknowledges that the appointment of the Secretary or Assistant Secretary of the Company (or their designee) as the escrow holder hereunder with the stated authorities is a material inducement to the Company to make this Option Agreement and that such appointment is coupled with an interest and is accordingly irrevocable. The Participant agrees that the Restricted Shares may be held electronically in a book entry system maintained by the Company’s transfer agent or other third-party and that all the terms and conditions of this Section 13 applicable to certificated Restricted Shares will apply with the same force and effect to such electronic method for holding the Restricted Shares. The Participant agrees that such escrow holder shall not be liable to any party hereto (or to any other party) for any actions or omissions unless such escrow holder is grossly negligent relative thereto. The escrow holder may rely upon any letter, notice or other document executed by any signature purported to be genuine and may resign at any time. Subject to the provisions of any security agreement relating to Participant’s purchase of the Shares, upon the vesting of Shares and termination of the Transfer Restrictions, the escrow holder will, upon request, transmit to the Participant the certificate evidencing such Shares.
14.
Additional Securities
. Any securities or cash received (other than a regular cash dividend) as the result of ownership of the Shares (the “Additional Securities”), including, but not by way of limitation, warrants, options and securities received as a stock dividend or stock split, or as a result of any transaction described in Section
4.2(b) of the Plan, shall be subject to the same conditions and restrictions as the Shares with respect to which they were issued. The Participant shall be entitled to direct the Company to exercise any warrant or option received as Additional Securities upon supplying the funds necessary to do so, in which event the securities so purchased shall constitute Additional Securities, but the Participant may not direct the Company to sell any such warrant or option. If Additional Securities consist of a convertible security, the Participant may exercise any conversion right, and any securities so acquired shall constitute Additional Securities. Appropriate adjustments to reflect the distribution of Additional Securities shall be made to the price per share to be paid upon the exercise of the Company Call Rights provided for in Section 13.1 of the Plan or the Repurchase Right in order to reflect the effect of any such transaction upon the Company’s capital structure. In the event of any change in certificates evidencing the Shares or the Additional Securities by reason of any recapitalization, reorganization or other transaction that results in the creation of Additional Securities, the escrow holder is authorized to deliver to the issuer the certificates evidencing the Shares or the Additional Securities in exchange for the certificates of the replacement securities.
15.
Distributions
. Subject to Section 14 and Section 16(e), the Company shall disburse to the Participant all regular cash dividends with respect to the Shares and Additional Securities (whether vested or not), less any applicable withholding obligations.
16.
Company’s Repurchase Right
.
(a)
Grant of Repurchase Right
. The Company is hereby granted the right (the “Repurchase Right”), exercisable at any time during the three (3) month period following the Termination Date, to repurchase all or any portion of the Shares that have not vested pursuant to the terms of the Vesting Schedule purchased upon exercise of the Option
(the “Share Repurchase Period”)
.
(b)
Exercise of the Repurchase Right
. The Repurchase Right shall be exercisable by written notice delivered to the Participant prior to the expiration of the Share Repurchase Period. The notice shall indicate the number of Shares to be repurchased and the date on which the repurchase is to be effected, such date to be not later than the last day of the Share Repurchase Period. On the date on which the repurchase is to be effected, the Company and/or its assigns shall pay to the Participant in cash or cash equivalents (including the cancellation of any purchase-money indebtedness) an amount equal to the lesser of the Exercise Price per Share previously paid by the Participant to the Company for such Shares and the Fair Market Value per Share on the date on which the repurchase is to be effected. Upon such payment or deposit into escrow for the benefit of the Participant, the Company and/or its assigns shall become the legal and beneficial owner of the Shares being repurchased and all rights and interest thereon or related thereto, and the Company shall have the right to transfer to its own name or its assigns the number of Shares being repurchased, without further action by the Participant.
(c)
Assignment
. Whenever the Company shall have the right to purchase Shares under this Repurchase Right or pursuant to Section 13.1 of the Plan, the Company may designate and assign one or more employees, officers, directors or shareholders of the Company or other persons or organizations, to exercise all or a part of the Company’s Repurchase Right or the Company’s rights under Section 13.1 of the Plan.
(d)
Termination of the Repurchase Right
. The Repurchase Right shall terminate with respect to any Shares for which it is not timely exercised.
(e)
Additional Shares or Substituted Securities
. In the event of any transaction described in Section 4.2 of the Plan, the Repurchase Right shall apply to the new capital stock or other property (including cash paid other than as a regular cash dividend) received in exchange for the Shares in consummation of any such transaction and such stock or property shall be deemed Additional Securities for purposes of this Agreement, but only to the extent the Shares are at the time covered by such Repurchase Right. Appropriate adjustments shall be made to the price per share payable upon exercise of the Repurchase Right to reflect the effect of any such transaction.
17.
Stop‑Transfer Notices
. In order to ensure compliance with the restrictions on transfer set forth in this Option Agreement, the Notice or the Plan, the Company may issue appropriate “stop transfer” instructions to its transfer agent, if any, and, if the Company transfers its own securities, it may make appropriate notations to the same effect in its own records.
18.
Refusal to Transfer
. The Company shall not be required (i) to transfer on its books any Shares that have been sold or otherwise transferred in violation of any of the provisions of this Option Agreement or (ii) to treat as owner of such Shares or to accord the right to vote or pay dividends to any purchaser or other transferee to whom such Shares shall have been so transferred.
19.
Tax Consequences.
(a)
The Participant may incur tax liability as a result of the Participant’s purchase or disposition of the Shares. THE PARTICIPANT SHOULD CONSULT A TAX ADVISER BEFORE EXERCISING THE OPTION OR DISPOSING OF THE SHARES.
(b)
Notwithstanding the Company’s good faith determination of the Fair Market Value of the Company’s Common Stock for purposes of determining the Exercise Price Per Share of the Option as set forth in the Notice, the taxing authorities may assert that the Fair Market Value of the Common Stock on the Date of Award was greater than the Exercise Price Per Share. If designated in the Notice as an Incentive Stock Option, the Option may fail to qualify as an Incentive Stock Option if the Exercise Price Per Share of the Option is less than the Fair Market Value of the Common Stock on the Date of Award. In addition, under Section 409A of the Code, if the Exercise Price Per Share of the Option is less than the Fair Market Value of the Common Stock on the Date of Award, the Option may be treated as a form of deferred compensation and the Participant may be subject to an acceleration of income recognition, an additional 20% tax, plus interest and possible penalties. In addition, the Company makes no
representation that the Option will comply with Section 409A of the Code and makes no undertaking to prevent Section 409A of the Code from applying to the Option or to mitigate its effects on any deferrals or payments made in respect of the Option. The Participant is encouraged to consult a tax adviser regarding the potential impact of Section 409A of the Code.
20.
Lock-Up Agreement
. The Shares are subject to the “lock-up” provisions of Section 14.18 of the Plan.
21.
Entire Agreement: Governing Law
. The Notice, the Plan and this Option Agreement constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and the Participant with respect to the subject matter hereof, and may not be modified adversely to the Participant’s interest except by means of a writing signed by the Company and the Participant. Nothing in the Notice, the Plan and this Option Agreement (except as expressly provided therein) is intended to confer any rights or remedies on any persons other than the parties. The Notice, the Plan and this Option Agreement are to be construed in accordance with and governed by the internal laws of the
State of California without giving effect to any choice of law rule that would cause the application of the laws of any jurisdiction other than the internal laws of the State of California or the rights and duties of the parties. Should any provision of the Notice, the Plan or this Option Agreement be determined to be illegal or unenforceable, such provision shall be enforced to the fullest extent allowed by law and the other provisions shall nevertheless remain effective and shall remain enforceable.
22.
Construction
. The captions used in the Notice and this Option Agreement are inserted for convenience and shall not be deemed a part of the Option for construction or interpretation. Except when otherwise indicated by the context, the singular shall include the plural and the plural shall include the singular. Use of the term “or” is not intended to be exclusive, unless the context clearly requires otherwise.
23.
Administration and Interpretation
. Any question or dispute regarding the administration or interpretation of the Notice, the Plan or this Option Agreement shall be submitted by the Participant or by the Company to the Committee. The resolution of such question or dispute by the Committee shall be final and binding on all persons.
24.
Venue
. The Company, the Participant, and the Participant’s assignees pursuant to Section 9 (the “parties”) agree that any suit, action, or proceeding arising out of or relating to the Notice, the Plan or this Option Agreement shall be brought in the United States District Court for the Northern District of California (or should such court lack jurisdiction to hear such action, suit or proceeding, in a California state court in the County of San Francisco) and that the parties shall submit to the jurisdiction of such court. The parties irrevocably waive, to the fullest extent permitted by law, any objection the party may have to the laying of venue for any such suit, action or proceeding brought in such court. If any one or more provisions of this Section 24 shall for any reason be held invalid or unenforceable, it is the specific intent of the parties that such provisions shall be modified to the minimum extent necessary to make it or its application valid and enforceable.
25.
Confidentiality
. To the extent required by applicable law, the Company shall provide to the Participant, during the period the Option is outstanding, copies of financial statements of the Company at least annually. The Participant understands and agrees that such financial statements are confidential and shall not be disclosed by the Participant, to any entity or person, for any reason, at any time, without the prior written consent of the Company, unless required by law. If disclosure of such financial statements is required by law, whether through subpoena, request for production, deposition, or otherwise, the Participant promptly shall provide written notice to Company, including copies of the subpoena, request for production, deposition, or otherwise, within five (5) business days of their receipt by the Participant and prior to any disclosure so as to provide Company an opportunity to move to quash or otherwise to oppose the disclosure. Notwithstanding the foregoing, the Participant may disclose the terms of such financial statements to his or her spouse or domestic partner, and for legitimate business reasons, to legal, financial, and tax advisors.
26.
Notices
. Any notice required or permitted hereunder shall be given in writing and shall be deemed effectively given upon personal delivery, upon deposit for delivery by an internationally recognized express mail courier service or upon deposit in the United States mail by certified mail (if the parties are within the United States), with postage and fees prepaid, addressed to the other party at its address as shown in these instruments, or to such other address as such party may designate in writing from time to time to the other party.
END OF AGREEMENT
EXHIBIT A
TIGERCAT PHARMA, INC. 2011 STOCK INCENTIVE PLAN
EXERCISE NOTICE
[COMPANY ADDRESS]
Attention: Secretary
1.
Effective as of today, ______________, ___ the undersigned (the “Participant”) hereby elects to exercise the Participant’s option to purchase ___________ shares of the Common Stock (the “Shares”) of ________________, Inc. (the “Company”) under and pursuant to the Company’s 2011Stock Incentive Plan, as amended from time to time (the “Plan”) and the [ ] Incentive [ ] Non-Qualified Stock Option Award Agreement (the “Option Agreement”) and Notice of Stock Option Award (the “Notice”) dated ______________, ________. Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Exercise Notice.
2.
Representations of the Participant
. The Participant acknowledges that the Participant has received, read and understood the Notice, the Plan and the Option Agreement and agrees to abide by and be bound by their terms and conditions.
3.
Rights as Shareholder
. Until the stock certificate evidencing such Shares is issued (as evidenced by the appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company), no right to vote or receive dividends or any other rights as a shareholder shall exist with respect to the Shares, notwithstanding the exercise of the Option. The Company shall issue (or cause to be issued) such stock certificate promptly after the Option is exercised. No adjustment will be made for a dividend or other right for which the record date is prior to the date the stock certificate is issued, except as provided in Section 10 of the Plan.
The Participant shall enjoy rights as a shareholder until such time as the Participant disposes of the Shares or the Company and/or its assignee(s) exercises its rights under Section 13 of the Plan or the Repurchase Right. Upon such exercise, the Participant shall have no further rights as a holder of the Shares so purchased except the right to receive payment for the Shares so purchased in accordance with the provisions of the Option Agreement, and the Participant shall forthwith cause the certificate(s) evidencing the Shares so purchased to be surrendered to the Company for transfer or cancellation.
4.
Delivery of Payment
. The Participant herewith delivers to the Company the full Exercise Price for the Shares.
5.
Tax Consultation
. The Participant understands that the Participant may suffer adverse tax consequences as a result of the Participant’s purchase or disposition of the Shares. The Participant represents that the Participant has consulted with any tax consultants the Participant deems advisable in connection with the purchase or disposition of the Shares and that the Participant is not relying on the Company for any tax advice.
6.
Tax Election; Taxes
. The Participant shall provide the Company with a copy of any timely filed 83(b) Election relating to the purchase of the Shares. If the Participant makes a timely 83(b) Election, the Participant shall immediately pay the Company (or the Affiliate that employs the Participant) the amount necessary to satisfy any applicable federal, state, and local income and employment tax withholding obligations. If the Participant does not make a timely 83(b) Election, the Participant shall, either at the time that the restrictions lapse under the Option Agreement and the Plan or at the time withholding is otherwise required by applicable law, pay the Company (or the Affiliate that employs the Participant) the amount necessary to satisfy any applicable federal, state, and local income and employment tax withholding obligations. In addition, the Participant agrees to satisfy all other applicable federal, state and local income and employment tax withholding obligations and herewith delivers to the Company the full amount of such obligations or has made arrangements acceptable to the Company to satisfy such obligations. In the case of an Incentive Stock Option, the Participant also agrees, as partial consideration for the designation of the Option as an Incentive Stock Option, to notify the Company in writing within thirty (30) days of any disposition of any shares acquired by exercise of the Option if such disposition occurs within two (2) years from the Grant Date or within one (1) year from the date the Shares were transferred to the Participant.
7.
Restrictive Legends
. The Participant understands and agrees that the Company shall cause the legends set forth below or legends substantially equivalent thereto, to be placed upon any certificate(s) evidencing ownership of the Shares together with any other legends that may be required by the Company or by state or federal securities laws:
THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 (THE “ACT”) OR ANY STATE SECURITIES LAWS AND MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED UNLESS AND UNTIL REGISTERED UNDER THE ACT OR, IN THE OPINION OF COUNSEL SATISFACTORY TO THE ISSUER OF THESE SECURITIES, SUCH OFFER, SALE OR TRANSFER, PLEDGE OR HYPOTHECATION IS IN COMPLIANCE THEREWITH.
THE SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO CERTAIN RESTRICTIONS ON TRANSFER, A RIGHT OF FIRST REFUSAL AND REPURCHASE RIGHTS HELD BY THE ISSUER OR ITS ASSIGNEE(S) AS SET FORTH IN THE OPTION AGREEMENT BETWEEN THE ISSUER AND THE ORIGINAL HOLDER OF THESE SHARES, A COPY OF WHICH MAY BE OBTAINED AT THE PRINCIPAL OFFICE OF THE ISSUER. SUCH TRANSFER RESTRICTIONS, RIGHT OF FIRST REFUSAL AND REPURCHASE RIGHTS ARE BINDING ON TRANSFEREES OF THESE SHARES.
THE ANTICIPATION, ALIENATION, ATTACHMENT, SALE, TRANSFER, ASSIGNMENT, PLEDGE, ENCUMBRANCE OR CHANGE OF THE SHARE OF STOCK REPRESENTED HEREBY ARE SUBJECT TO THE TERMS AND CONDITIONS (INCLUDING FORFEITURE) OF THE TIGERCAT PHARMA, INC. (THE “COMPANY”) 2011 STOCK INCENTIVE PLAN (AS THE SAME MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME), AND AN AWARD AGREEMENT ENTERED INTO BETWEEN THE REGISTERED OWNER AND THE COMPANY. COPIES OF SUCH PLAN AND AWARD AGREEMENT ARE ON FILE AT THE PRINCIPAL OFFICE OF THE COMPANY”
8.
Successors and Assigns
. The Company may assign any of its rights under this Exercise Notice to single or multiple assignees, and this agreement shall inure to the benefit of the successors and assigns of the Company. Subject to the restrictions on transfer herein set forth, this Exercise Notice shall be binding upon the Participant and his or her heirs, executors, administrators, successors and assigns.
9.
Construction
. The captions used in this Exercise Notice are inserted for convenience and shall not be deemed a part of this agreement for construction or interpretation. Except when otherwise indicated by the context, the singular shall include the plural and the plural shall include the singular. Use of the term “or” is not intended to be exclusive, unless the context clearly requires otherwise.
10.
Administration and Interpretation
. The Participant hereby agrees that any question or dispute regarding the administration or interpretation of this Exercise Notice shall be submitted by the Participant or by the Company to the Committee. The resolution of such question or dispute by the Committee shall be final and binding on all persons.
11.
Governing Law; Severability
. This Exercise Notice is to be construed in accordance with and governed by the internal laws of the State of California without giving effect to any choice of law rule that would cause the application of the laws of any jurisdiction other than the internal laws of the State of California to the rights and duties of the parties. Should any provision of this Exercise Notice be determined by a court of law to be illegal or unenforceable, such provision shall be enforced to the fullest extent allowed by law and the other provisions shall nevertheless remain effective and shall remain enforceable.
12.
Notices
. Any notice required or permitted hereunder shall be given in writing and shall be deemed effectively given upon personal delivery, upon deposit for delivery by an internationally recognized express mail courier service or upon deposit in the United States mail by certified mail (if the parties are within the United States), with postage and fees prepaid, addressed to the other party at its address as shown below beneath its signature, or to such other address as such party may designate in writing from time to time to the other party.
13.
Further Instruments
. The parties agree to execute such further instruments and to take such further action as may be reasonably necessary to carry out the purposes and intent of this agreement.
14.
Entire Agreement
. The Notice, the Plan and the Option Agreement are incorporated herein by reference and together with this Exercise Notice constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and the Participant with respect to the subject matter hereof, and may not be modified adversely to the Participant’s interest except by means of a writing signed by the Company and the Participant. Nothing in the Notice, the Plan, the Option Agreement and this Exercise Notice (except as expressly provided therein) is intended to confer any rights or remedies on any persons other than the parties.
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Submitted by:
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Accepted by:
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PARTICIPANT:
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TIGERCAT PHARMA, INC.
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By:
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Title:
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(Signature)
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Address
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Address
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[COMPANY ADDRESS]
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EXHIBIT B
TIGERCAT PHARMA, INC. 2011 STOCK INCENTIVE PLAN
INVESTMENT REPRESENTATION STATEMENT
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PARTICIPANT:
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COMPANY:
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SECURITY:
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COMMON STOCK
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AMOUNT:
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DATE:
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In connection with the purchase of the above‑listed Securities, the undersigned Participant represents to the Company the following:
(a)
Participant is aware of the Company’s business affairs and financial condition and has acquired sufficient information about the Company to reach an informed and knowledgeable decision to acquire the Securities. Participant is acquiring these Securities for investment for Participant’s own account only and not with a view to, or for resale in connection with, any “distribution” thereof within the meaning of the Securities Act of 1933, as amended (the “Securities Act”).
(b)
Participant acknowledges and understands that the Securities constitute “restricted securities” under the Securities Act and have not been registered under the Securities Act in reliance upon a specific exemption therefrom, which exemption depends upon among other things, the bona fide nature of Participant’s investment intent as expressed herein. Participant further understands that the Securities must be held indefinitely unless they are subsequently registered under the Securities Act or an exemption from such registration is available. Participant further acknowledges and understands that the Company is under no obligation to register the Securities. Participant understands that the certificate evidencing the Securities will be imprinted with a legend which prohibits the transfer of the Securities unless they are registered or such registration is not required in the opinion of counsel satisfactory to the Company.
(c)
Participant is familiar with the provisions of Rule 701 and Rule 144, each promulgated under the Securities Act, which, in substance, permit limited public resale of “restricted securities” acquired, directly or indirectly from the issuer thereof, in a non‑public offering subject to the satisfaction of certain conditions. Rule 701 provides that if the issuer qualifies under Rule 701 at the time of the grant of the Option to the Participant, the exercise will be exempt from registration under the Securities Act. In the event the Company becomes subject to the reporting requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, ninety (90) days thereafter (or such longer period as any market stand‑off agreement may require) the Securities exempt under Rule 701 may be resold, except in the case of affiliates,
such Securities may be resold subject to the satisfaction of the applicable conditions specified by Rule 144, including: (1) the availability of certain public information about the Company, (2) the amount of Securities being sold during any three month period not exceeding specified limitations, (3) the resale being made in an unsolicited “broker’s transaction,” in transactions directly with a “market maker” or “riskless principal transactions” (as said terms are defined under the Securities Exchange Act of 1934) and (4) the timely filing of a Form 144, if applicable.
In the event that the Company does not qualify under Rule 701 at the time of sale of the Securities, then the Securities may be resold in certain limited circumstances subject to the provisions of Rule 144, which may require: the availability of current public information about the Company; the resale to occur more than a specified period after the purchase and full payment (within the meaning of Rule 144) for the Securities; and, in the case of the sale of Securities by an affiliate, the satisfaction of the conditions set forth in sections (2), (3) and (4) of the paragraph immediately above.
(d)
Participant further understands that in the event all of the applicable requirements of Rule 701 or 144 are not satisfied, registration under the Securities Act, compliance with Regulation A, or some other registration exemption will be required; and that, notwithstanding the fact that Rules 144 and 701 are not exclusive, the Staff of the Securities and Exchange Commission has expressed its opinion that persons proposing to sell private placement securities other than in a registered offering and otherwise than pursuant to Rules 144 or 701 will have a substantial burden of proof in establishing that an exemption from registration is available for such offers or sales, and that such persons and their respective brokers who participate in such transactions do so at their own risk. Participant understands that no assurances can be given that any such other registration exemption will be available in such event.
(e)
Participant represents that the Participant is a resident of the state of ____________________.
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Signature of Participant:
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Date:
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EXHIBIT C
STOCK ASSIGNMENT SEPARATE FROM CERTIFICATE
[Please sign this document but do not date it. The date and information of the transferee will be completed if and when the shares are assigned.]
FOR VALUE RECEIVED, ____________________________ hereby sells, assigns and transfers unto _______________________, __________________ (____) shares of the Common Stock of _______________________, Inc., a ________________ corporation (the “Company”), standing in his name on the books of, represented by Certificate No. __ herewith, and does hereby irrevocably constitute and appoint the Secretary of the Company attorney to transfer the said stock in the books of the Company with full power of substitution.
DATED: ________________
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EXHIBIT D
ELECTION UNDER SECTION 83(b)
OF THE INTERNAL REVENUE CODE OF 1986
The undersigned taxpayer hereby elects, pursuant to the Internal Revenue Code, to include in gross income for ________ the amount of any compensation taxable in connection with the taxpayer’s receipt of the property described below:
1.
The name, address, taxpayer identification number and taxable year of the undersigned are:
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TAXPAYER’S NAME
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TAXPAYER’S SOCIAL SECURITY NO.:
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TAXABLE YEAR:
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Calendar Year
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ADDRESS:
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2.
The property which is the subject of this election is __________ shares of common stock of ______________________.
3.
The property was transferred to the undersigned on ____________, ____.
4.
The property is subject to the following restrictions: The property is subject to a repurchase right pursuant to which the issuer has the right to acquire the property at the lesser of the original purchase price or the fair market value of the property if for any reason taxpayer’s employment or service with the issuer is terminated. The issuer’s repurchase right lapses in a series of periodic installments.
5.
The fair market value of the property at the time of transfer (determined without regard to any restriction other than a restriction which by its terms will never lapse) is: $_______ per share x ________ shares = $___________.
6.
The undersigned paid $______ per share x _________ shares for the property transferred or a total of $______________.
The undersigned has submitted a copy of this statement to the person for whom the services were performed in connection with the undersigned’s receipt of the above-described property. The undersigned taxpayer is the person performing the services in connection with the transfer of said property.
The undersigned will file this election with the Internal Revenue Service office to which he or she files his annual income tax return not later than 30 days after the date of transfer of the property. Additionally, the undersigned will include a copy of the election with his income tax return for the taxable year in which the property is transferred.
The property described in the above Section 83(b) election is comprised of shares of common stock acquired pursuant to the exercise of an incentive stock option under Section 422 of the Internal Revenue Code (the “Code”). Accordingly, the purpose of this election is to have the alternative minimum taxable income attributable to the purchased shares measured by the amount by which the fair market value of such shares at the time of their transfer to the Taxpayer exceeds the purchase price paid for the shares. In the absence of this election, such alternative minimum taxable income would be measured by the spread between the fair market value of the purchased shares and the purchase price which exists on the various lapse dates in effect for the forfeiture restrictions applicable to such shares.
THIS PAGE 2 IS TO BE ATTACHED TO ANY SECTION 83(b) ELECTION FILED IN CONNECTION WITH THE EXERCISE OF AN INCENTIVE STOCK OPTION.
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the use in this Registration Statement on Form S-1 and related Prospectus dated December 28, 2017 of our report dated October 29, 2017, except for the subsequent events noted in Note 12, as to which the date is December 28, 2017, with respect to the financial statements of Menlo Therapeutics, Inc. for the years ended December 31, 2016 and 2015, and to the reference to us under the heading “Experts” in this Prospectus which is part of this Registration Statement.
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/s/ Mayer Hoffman McCann P.C.
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San Diego, California
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December 28, 2017
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