AND EXCHANGE COMMISSION
Washington, D.C. 20549
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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Item 1.01. Entry into Material Definitive Agreement.
Global Development, Option and License Agreement
October 12, 2017 (the Effective Date), Codexis, Inc. (the Company) entered into a Global Development, Option and License Agreement (the Agreement) with Nestec Ltd. (Nestlé Health Science),
and, solely for the purpose of the integration and the dispute resolution clauses of the Agreement, Nestlé Health Science S.A.
Pursuant to the
Agreement, the Company granted to Nestlé Health Science, under certain of the Companys patent rights and know-how: (i) an option (the Option) to obtain an exclusive, worldwide,
royalty-bearing, sublicensable license to develop and commercialize certain products (each, a Product) based on the Companys therapeutic enzyme product candidates for the treatment of hyperphenylalaninemia (HPA), and
(ii) an exclusive right of first negotiation (the Right of First Negotiation) 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 ROFN Field).
Under the terms of the Agreement, upon the
License Effective Date (defined below) after the Option trigger, Nestlé Health Science will be granted a license to any enzyme (each, a Compound) covered by specified patent applications, other than any enzyme that has other
clinically significant, specified activity against another molecule, unless that enzymes 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 Companys enzyme CDX-6114 (the Initial Compound).
Under the terms of the Agreement,
Nestlé 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 Option Trigger Date). The effective date of the license granted in connection with the Option exercise will either be the date that Nestlé Health Science notifies the Company of Nestlé
Health Sciences exercise of the Option if Nestlé Health Science determines that no antitrust clearance is necessary, or the date that any antitrust clearance Nestlé Health Science determines is required is obtained (License
Effective Date). The Option will expire 60 days after the Option Trigger Date if unexercised by Nestlé Health Science. If Nestlé Health Science exercises the Option and determines that a filing under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976 (HSR) is necessary in connection with the Option exercise, the Companys 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) October 12, 2022, (ii) the date on which Nestlé Health Science and the Company have entered into definitive agreements pursuant to which
Nestlé Health Science has obtained licenses under two separate enzymes in the ROFN Field, or (iii) the expiration or termination (other than the Companys termination) of the Agreement. The Agreement continues in effect, unless
earlier terminated, until (i) if Nestlé Health Science exercises the Option, the expiration of all of Nestlé Health Sciences payment obligations under the Agreement or (ii) if Nestlé Health Science does not
exercise the Option, the earlier of October 12, 2022 and the date on which Nestlé Health Science and the Company have entered into definitive agreements under which Nestlé Health Science has obtained licenses under two enzymes in
the ROFN Field. Nestlé 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 Nestlé Health Science challenges the validity or enforceability of any of the Companys patents covering the Compound. Either party may terminate the Agreement in the event of the other partys uncured material breach
The Agreement also sets forth the parties 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, Nestlé Health Science will be generally responsible for development activities. The Companys 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 partys 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, Nestlé Health Science is obligated to pay the Company an upfront cash payment of $14 million within 30 days after Effective Date and, in the event Nestlé Health Science exercises the Option, $3 million within 60
days after the License Effective Date. Other potential payments from Nestlé Health Science to the Company under the Agreement include (i) development and approval milestones of up to $90 million, (ii) sales-based milestones of
up to $250 million in the aggregate, which aggregate amount is achievable if net sales exceed $1 billion in a single year, and (iii) 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 Companys Annual Report on Form 10-K for the year ending December 31, 2017.
This Current Report on Form 8-K contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). These statements include, but are not limited to,
expectations regarding the Companys strategic collaboration with Nestlé 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 Companys control and that could materially affect actual results. Factors that could materially affect actual results include the Companys dependence on its licensees and collaborators; the
Companys dependence on a limited number of products and customers; potential adverse effects to the Companys business if its customers products are not received well in the markets; the Companys ability to deploy its
technology platform in new market spaces; the Companys dependence on key personnel; the Companys 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 Companys biocatalysts. Additional factors that could materially affect actual results can be found in the Companys
Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 9, 2017 and the Companys Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission on August 9, 2017, including under the caption Risk Factors. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Item 7.01. Regulation FD Disclosure.
October 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
The information furnished pursuant to this Item 7.01 of this Report, including Exhibit 99.1 attached hereto, shall not be deemed
filed for purposes of Section 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 filed or incorporated by reference therein.
Item 9.01. Financial Statements and Exhibits.
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 12, 2017
Senior Vice President and Chief