|
Item 1.01.
|
Entry into a Material Definitive Agreement.
|
On October 13, 2017, Syndax Pharmaceuticals, Inc. (the
“Company”) entered into a license agreement (the “Agreement”) with Vitae Pharmaceuticals, Inc. (“Allergan”), a subsidiary of Allergan plc, under which Allergan granted to the Company a worldwide, sublicenseable,
exclusive license to a portfolio of preclinical, orally-available small molecule inhibitors of the interaction of Menin with the Mixed Lineage Leukemia (“MLL”) protein (the “Menin Assets”).
Pursuant to the Agreement, the Company will make an upfront payment of $5.0 million to Allergan, and, subject to the achievement of certain milestone
events, the Company may be required to pay Allergan up to $99 million in
one-time
development and regulatory milestone payments over the term of the Agreement. In the event that the Company or any of its
affiliates or sublicensees commercializes the Menin Assets, the Company will also be obligated to pay Allergan low single to low double-digit royalties on sales, subject to reduction in certain circumstances, as well as up to an aggregate of
$70 million in potential
one-time
sales-based milestone payments based on achievement of certain annual sales thresholds. Under certain circumstances, the Company may be required to share a percentage of
non-royalty
income from sublicensees, subject to certain deductions, with Allergan. The Company will be solely responsible for the development and commercialization of the Menin Assets.
Each party may terminate the agreement for the other party’s uncured material breach or insolvency, and the Company may terminate the agreement at will
at any time upon advance written notice to Allergan. Allergan may terminate the agreement if the Company or any of its affiliates or sublicensees institutes a legal challenge to the validity, enforceability or patentability of the licensed patent
rights. Unless terminated earlier in accordance with its terms, the agreement will continue on a
country-by-country
and
product-by-product
basis until the later of: (i) the expiration of all of the licensed patent rights in such country; (ii) the expiration of all regulatory exclusivity applicable to the product in
such country; and (iii) 10 years from the date of the first commercial sale of the product in such country.
The foregoing description of the Agreement is
only a summary and is qualified in its entirety by reference to the Agreement, a copy of which will be filed as an exhibit to the Company’s Annual Report on Form
10-K
for the year ended December 31,
2017.
A copy of the press release issued in connection with the Company’s announcement of the Agreement on October 17, 2017 is attached hereto
as Exhibit 99.1.
Cautionary Note on Forward-Looking Statements
This Current Report on Form
8-K
(the “Current Report”) contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend,” “believe” and similar
expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on the Company’s expectations and
assumptions as of the date of this Current Report. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this
Current Report include, but are not limited to, the Company’s potential payment of upfront and milestone payments and royalties. Many factors may cause differences between current expectations and actual results, including unexpected safety or
efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of
the Company’s collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause the Company’s actual
results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections
contained therein. Except as required by law, the Company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.