Exhibit 10.1

[*] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

AMENDMENT #4 TO

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

 

This Amendment #4 to LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
(“Amendment”), is entered into between Syndax Pharmaceuticals, Inc., a Delaware
corporation having a place of business at 35 Gatehouse Drive, Building D, Floor
3, Waltham, MA 02451 USA (“Syndax”) and Kyowa Hakko Kirin Co., Ltd., a Japanese
corporation having a place of business at 1-9-2, Otemachi, Chiyoda-ku, Tokyo
100-0004, Japan (“KHK”), effective as of May 29, 2018 (the “Amendment Effective
Date”).

 

Reference is made to that the LICENSE, DEVELOPMENT AND COMMERCIALIZATION
AGREEMENT by and between Syndax and KHK entered into as of December 19, 2014
(“Agreement”), as previously amended. As of the Amendment Effective Date, the
Agreement is hereby further amended as set forth in this Amendment. Capitalized
terms used but not defined herein shall have the meanings assigned to such terms
in the Agreement.

 

The parties agree that the following new sentences are hereby added as Section
4.4.1:

 

“4.4.1 Notwithstanding the Section 4,4 above, Syndax shall use best efforts to
ensure that a laboratory [*] at the Medical Oncology Branch, Center for Cancer
Research, National Cancer Institute (“NCI”), which has performed or is
performing analyses of blood samples from one or more Clinical Trials on
Entinostat for Syndax under the Cooperative Research and Development Agreement
#836 “Preclinical and Clinical Development of MS-275 (NSC-706995), a Histone
Deacetylase Inhibitor, as an Anti-Cancer Agent” (CRADA), will, pursuant to KHK’s
request, perform analyses of blood samples from a phase 2 study  of Entinostat
in subjects with advanced or recurrent breast cancer in Japan being conducted by
KHK (or its licensees) and provide to KHK the data developed or generated
therefrom. Unless otherwise agreed upon between Syndax and KHK, the cost of such
analyses of blood samples to be paid to NCI shall be the following:

 

 

(a)

Total cost will be USD [*] for [*] samples. If the number of samples is more
than [*] samples, additional costs will be USD [*] per sample.

 

(b)

Syndax will pay to NCI USD [*] as an initial payment upon the execution of the
amendment #13 of the CRADA with NCI. Syndax will pay to NCI the remaining
cost, USD [*] plus the additional costs for more than [*] samples (if
necessary), when NCI has completed the measurement.

 

Further, Syndax shall use best efforts to ensure that NCI will keep the
documents of the results for and on behalf of KHK at least for [*] after the end
of such blood sample analyses.

Subject to the foregoing, the cost of such work for analyses of blood samples
from the Territory Trials and document retention will be borne by KHK using the
following procedure:

Payment for such support will be [*] in connection with performing such analyses
and document retention, due on a [*]. Syndax will pay to NCI the [*] for such
work, and KHK agrees to reimburse Syndax for such cost no later than [*] after
receipt of invoice(s) detailing same.”

 

All other terms, obligations and conditions of the Agreement shall remain in
full force and effect.

 

This Amendment may be executed in one or more counterparts by the parties by a
person having authority to bind the party, each of which when executed and
delivered by facsimile, electronic transmission or by mail delivery, will be an
original and all of which shall constitute but one and the same Amendment.

--------------------------------------------------------------------------------

 

Syndax Pharmaceuticals, Inc.

 

Kyowa Hakko Kirin Co., Ltd.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

By:

 

/s/ Luke J. Albrecht

 

By:

 

/s/ Yasuo Fujii

Name:

 

Luke J. Albrecht

 

Name:

 

Yasuo Fujii

Title:

 

General Counsel

 

Title:

 

Effective Officer,

 

 

 

 

 

 

Director,

 

 

 

 

 

 

Head of Business Development

 

 

 

 

 

 

Department

Date:

 

May 29, 2018

 

Date:

 

May 28, 2018

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, is filed with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.