8-K: Current report filing
Published on October 12, 2017
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): October 12, 2017
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五星体育直播
(Exact name of Registrant as Specified in its Charter)
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Delaware | 听 | 001-34705听听听听听 | 听 | 71-0872999 |
(State or other jurisdiction of incorporation) |
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听 | (I.R.S. Employer Identification No.) |
200 Penobscot Drive
Redwood City, CA 94063
(Address of Principal Executive Offices) (Zip Code)
(650) 421-8100
(Registrant聮s telephone number, including area code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
鈽愄齏ritten communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
鈽愄齋oliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
鈽愄齈re-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
鈽愄齈re-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (搂230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (搂240.12产-2 of this chapter).
Emerging growth company 听鈽
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section听13(a) of the Exchange Act. 听鈽
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Item听1.01. Entry into Material Definitive Agreement.
Global Development, Option and License Agreement
On October听12, 2017 (the 聯Effective Date聰), 五星体育直播 (the 聯Company聰) entered into a Global Development, Option and License Agreement (the 聯Agreement聰) with Nestec Ltd. (聯Nestl茅 Health Science聰), and, solely for the purpose of the integration and the dispute resolution clauses of the Agreement, Nestl茅 Health Science S.A.
Pursuant to the Agreement, the Company granted to Nestl茅 Health Science, under certain of the Company聮s patent rights and know-how: (i)听an option (the 聯Option聰) to obtain an exclusive, worldwide, royalty-bearing, sublicensable license to develop and commercialize certain products (each, a 聯Product聰) based on the Company聮s therapeutic enzyme product candidates for the treatment of hyperphenylalaninemia (聯HPA聰), and (ii)听an exclusive right of first negotiation (the 聯Right of First Negotiation聰) to obtain an exclusive worldwide license to develop and commercialize any enzyme discovered by the Company for use in the field of the prevention, diagnosis, treatment and management of inborn errors of amino acid metabolism (the 聯ROFN Field聰).
Under the terms of the Agreement, upon the License Effective Date (defined below) after the Option trigger, Nestl茅 Health Science will be granted a license to any enzyme (each, a 聯Compound聰) covered by specified patent applications, other than any enzyme that has other clinically significant, specified activity against another molecule, unless that enzyme聮s specified activity against phenylalanine is ten times greater than its activity against such other molecule (in which case it is not excluded). Furthermore, the Company, its affiliates and customers generally will retain the right to use any enzyme as a biocatalyst, provided that preclinical development of such enzyme has not commenced. The first Compound to be developed under the Agreement is the Company聮s enzyme CDX-6114 (the 聯Initial Compound聰).
Under the terms of the Agreement, Nestl茅 Health Science has the sole discretion to exercise the Option after the effectiveness of an investigational new drug application filed by the Company for the study of the Initial Compound for the treatment of HPA and the completion of a Phase Ia study by the Company (the 聯Option Trigger Date聰). The effective date of the license granted in connection with the Option exercise will either be the date that Nestl茅 Health Science notifies the Company of Nestl茅 Health Science聮s exercise of the Option if Nestl茅 Health Science determines that no antitrust clearance is necessary, or the date that any antitrust clearance Nestl茅 Health Science determines is required is obtained (聯License Effective Date聰). The Option will expire 60 days after the Option Trigger Date if unexercised by Nestl茅 Health Science. If Nestl茅 Health Science exercises the Option and determines that a filing under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (聯HSR聰) is necessary in connection with the Option exercise, the Company聮s obligation to grant the license under the Option will expire if the HSR filing does not receive clearance within 180 days of filing and such delay is not attributable to any material failure on the part of the Company to cooperate in the HSR review process.
Under the terms of the Agreement, the Right of First Negotiation will expire on the earliest to occur of (i)听October听12, 2022, (ii) the date on which Nestl茅 Health Science and the Company have entered into definitive agreements pursuant to which Nestl茅 Health Science has obtained licenses under two separate enzymes in the ROFN Field, or (iii)听the expiration or termination (other than the Company聮s termination) of the Agreement. The Agreement continues in effect, unless earlier terminated, until (i)听if Nestl茅 Health Science exercises the Option, the expiration of all of Nestl茅 Health Science聮s payment obligations under the Agreement or (ii)听if Nestl茅 Health Science does not exercise the Option, the earlier of October听12, 2022 and the date on which Nestl茅 Health Science and the Company have entered into definitive agreements under which Nestl茅 Health Science has obtained licenses under two enzymes in the ROFN Field. Nestl茅 Health Science may terminate the Agreement in the event of serious safety issues related to the Compound or Product and at its convenience after the first anniversary of the Effective Date. The Company may terminate the Agreement if Nestl茅 Health Science challenges the validity or enforceability of any of the Company聮s patents covering the Compound. Either party may terminate the Agreement in the event of the other party聮s uncured material breach or insolvency.
The Agreement also sets forth the parties聮 respective obligations for development, commercialization, regulatory and manufacturing and supply activities for the Initial Compound and Product containing the Initial Compound. Prior to the earlier to occur of the Option expiration date or the License Effective Date, the Company will be generally responsible for development activities, including a Phase Ia study. Following the License Effective Date, Nestl茅 Health Science will be generally responsible for development activities. The Company聮s development activities will be governed by a development plan and overseen by a joint steering committee. The parties will establish a patent committee to discuss strategies and coordinate activities for the patents related to Initial Compound and Product containing the Initial Compound, and will jointly own all inventions and information that
result from each party聮s activities performed under the Agreement. The Agreement also contains customary representations and warranties by the parties, intellectual property protection provisions, certain indemnification rights in favor of each party and customary confidentiality provisions and limitations of liability.
Pursuant to the Agreement, Nestl茅 Health Science is obligated to pay the Company an upfront cash payment of $14听million within 30 days after Effective Date and, in the event Nestl茅 Health Science exercises the Option, $3听million within 60 days after the License Effective Date. Other potential payments from Nestl茅 Health Science to the Company under the Agreement include (i)听development and approval milestones of up to $90听million, (ii)听sales-based milestones of up to $250听million in the aggregate, which aggregate amount is achievable if net sales exceed $1听billion in a single year, and (iii)听tiered royalties, at percentages ranging from the middle single digits to low double-digits, of net sales of Product.
The foregoing description of the Agreement is qualified in its entirety by reference to the Agreement, a copy of which will be filed as an exhibit to the Company聮s Annual Report on Form 10-K for the year ending December听31, 2017.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of Section听21E of the Securities Exchange Act of 1934, as amended (the 聯Exchange Act聰). These statements include, but are not limited to, expectations regarding the Company聮s strategic collaboration with Nestl茅 Health Science. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond the Company聮s control and that could materially affect actual results. Factors that could materially affect actual results include the Company聮s dependence on its licensees and collaborators; the Company聮s dependence on a limited number of products and customers; potential adverse effects to the Company聮s business if its customers聮 products are not received well in the markets; the Company聮s ability to deploy its technology platform in new market spaces; the Company聮s dependence on key personnel; the Company聮s ability to compete may decline if it loses some of its intellectual property rights; third party claims that the Company infringes third party intellectual property rights; and the Company could face increased competition if third parties misappropriate the Company聮s biocatalysts. Additional factors that could materially affect actual results can be found in the Company聮s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March听9, 2017 and the Company聮s Quarterly Report on Form 10-Q filed听with the Securities and Exchange Commission on August听9, 2017, including under the caption 聯Risk Factors.聰 The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Item听7.01. Regulation FD Disclosure.
On October听12, 2017, the Company issued a press release announcing the Agreement. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein.
The information furnished pursuant to this Item 7.01 of this Report, including Exhibit 99.1 attached hereto, shall not be deemed 聯filed聰 for purposes of Section听18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, regardless of any general incorporation language in any such filing, unless the Company expressly sets forth in such filing that such information is to be considered 聯filed聰 or incorporated by reference therein.
Item听9.01. Financial Statements and Exhibits.
(d) Exhibits.
EXHIBIT INDEX
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听听Exhibit听No.听听听听 |
听 | 听听Description |
听听99.1 | 听 | 听听Press release, dated October听12, 2017. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: October听12, 2017
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CODEXIS, INC. | ||
By: | 听 | /s/ Gordon Sangster听听听听听听听听听听听听听听听听听听听听听听听听听听听听 听 |
Name: | 听 | Gordon Sangster |
Title: | 听 | Senior听Vice听President听and听Chief Financial Officer |