Document:

sndx-ex101_184.htm

[*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is not material and would be competitively harmful if publicly disclosed.

 

Exhibit 10.1

 

 

AMENDMENT NO. 11 TO

CLINICAL TRIAL AGREEMENT 
BETWEEN 

ECOG-ACRIN CANCER RESEARCH GROUP

AND SYNDAX PHARMACEUTICALS, INC. 

 

This Amendment No. 11 to Clinical Trial Agreement (the “Amendment” or “Amendment 11”) is entered into as of July 1, 2019 (the “Effective Date”), by and between ECOG-ACRIN Cancer Research Group, on behalf of itself and its member hospitals, institutions and physicians (the “Group,” “ECOG” or “ECOG-ACRIN”), and Syndax Pharmaceuticals, Inc. (“Company” or “Syndax”).

 

WITNESSETH:

 

WHEREAS, pursuant to the Clinical Trial Agreement dated March 14, 2014 between the parties (“Agreement”), the parties agreed to certain terms specified therein for research services related to Group’s performance of the Study; and

 

WHEREAS, the parties agree to increase the support for the Study to offset the expenses of additional areas associated with [*] as set forth herein.

 

NOW, THEREFORE, the parties hereto, intending to be legally bound hereby, agree as follows:

 

	
A.
	
The following is added to Section 1.G of the Agreement:

 

The Company will provide financial support to the Group in the amount of $106,398 to support the activities associated with [*] as set forth in Exhibit G.  The maximum financial support for the Agreement is increased from $24,831,545 by $106,398 to $24,937,943.

 

	
B.
	
Exhibit B of the Agreement is deleted in its entirety and replaced by Exhibit B attached hereto.

 

	
C.
	
Exhibit G attached hereto is hereby added as Exhibit G of the Agreement thereto.

 

D.   This Amendment constitutes the full understanding of the parties and a complete and exclusive statement of the terms of their agreement with respect to the subject matter described herein, and no terms, conditions, understanding, or agreement purporting to modify or vary the terms of this Amendment shall be binding unless made in writing and signed by the parties.

 

	
E.
	
Except to the extent amended herein, all of the terms and conditions of the Agreement remain in full force and effect.

 

	
F.
	
Capitalized terms herein that are not defined shall have the meaning ascribed to such terms in the Agreement.

 

	
G.
	
This Amendment may be executed in one or more counterparts, each of which shall be deemed an original, but all of which shall be considered one and the same instrument.

 

 

IN WITNESS WHEREOF, the parties hereto have executed this Amendment, as of the Effective Date, by proper persons duly authorized.

ECOG-ACRIN Cancer Research Group   Syndax Pharmaceuticals, Inc.

 

 

/s/ Donna Marinucci/s/ Sue Fischer
Name: Donna Marinucci Name: Sue Fischer

Title:   Executive Director Title: VP Clinical Operations

 

 

2

 

EXHIBIT B

E2112 Budget & Payment Schedule

 

	
 
	
A.
	
Budget Details

 

	
 
	
1.
	
Budget – Excluding Amendments

 

The budget for this project is $19,406,948 which is itemized as follows:

[*]

 

	
 
	
2.
	
Budget – Amendment 1

 

The budget for Amendment 1 is $1,200,000 which is itemized as follows:

[*]

 

	
 
	
3.
	
Budget – Amendment 3 

 

The budget for Amendment 3 ([*]) is $450,000 which is itemized as follows:

[*]

 

	
 
	
4.
	
Budget – Amendment 4 

 

The budget for Amendment 4 ([*]) is $7,908 which is itemized as follows:

[*]

 

The budget for Amendment 5 is $30,121 which is itemized as follows:

[*]

 

	
 
	
5.
	
Budget – Amendment 6

 

The budget for Amendment 6 is $287,438 which is itemized as follows:

[*]

Statistical services being provided through Amendment 5 is limited to [*] of [*] services plus [*] of Group [*].

 

	
 
	
6.
	
Budget – Amendment 7

 

The budget for Amendment 7 is $484,091 which is itemized as follows:

[*]

 

	
 
	
7.
	
Budget – Amendment 8

 

The budget for Amendment 8 is $1,582,064 which is itemized as follows:

[*]

 

	
 
	
9.
	
Budget – Amendment 9

3

 

 

The budget for Amendment 9 is $357,482 which is itemized as follows:

[*]

 

	
 
	
10.
	
Budget – Amendment 10

 

The budget for Amendment 10 is $177,121 which is to pay [*] provided by [*]. 

 

	
 
	
11.
	
Budget – Amendment 11

 

The budget for Amendment 11 is $106,398 which is itemized as follows:

[*]

 

	
 
	
12.
	
Invoicing and Payments

 

Company will make payments within [*] of receipt of invoices from Group according to the Payment Schedule herein. Payments will be made to as set forth in Section 1.B of the Agreement as follows:

 

ECOG Research and Education Foundation, Inc.

Agent for ECOG-ACRIN Cancer Research Group 

Attn:  Donna Marinucci

1818 Market Street, Suite 3000

Philadelphia, PA 19103

Group will send invoices to the following address: 

Sue Fischer 

Vice President, Clinical Operations 

Syndax Pharmaceuticals, Inc.

35 Gatehouse Drive, Building D, 3rd Flr

Waltham, MA 02451

 

	
 
	
B.
	
Payment Schedule – Excluding Amendments

Group will submit invoices to Company in accordance with the following Payment Schedule:

[*]

 

	
 
	
C.
	
Payment Schedule – Amendment 1

Group will submit invoices to Company in accordance with the following Payment Schedule:

[*]

 

	
 
	
D.
	
Payment Schedule – Amendment 3 ([*])

Group will submit invoices to Company in accordance with the following Payment Schedule:

[*]

 

	
 
	
E.
	
Payment Schedule – Amendment 4

Group will submit invoices to Company in accordance with the following Payment Schedule:

4

 

[*]

 

	
 
	
F.
	
Payment Schedule – Amendment 5

Group will submit invoices to Company in accordance with the following Payment Schedule:

[*]

 

	
 
	
G.
	
Payment Schedule – Amendment 6

Group will submit invoices to Company in accordance with the following Payment Schedule:

[*]

 

	
 
	
H.
	
Payment Schedule – Amendment 7

Group will submit invoices to Company in accordance with the following Payment Schedule:

[*]

 

	
 
	
I.
	
Payment Schedule – Amendment 8

Group will submit invoices to Company in accordance with the following Payment Schedule:

[*]

 

	
 
	
J.
	
Payment Schedule – Amendment 9

Group will submit invoices to Company in accordance with the following Payment Schedule:

[*]

 

	
 
	
K.
	
Payment Schedule – Amendment 10

Group will submit invoices to Company in accordance with the following Payment Schedule:

[*]

 

	
 
	
L.
	
Payment Schedule – Amendment 11

Group will submit invoices to Company in accordance with the following Payment Schedule:

[*]

5

 

EXHIBIT G

E2112 Scope of Work – Amendment 11

 

 

Protocol Title:   A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Patients with Hormone Receptor-Positive Advanced Breast Cancer

[*]

6sndx-ex102_185.htm

[*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is not material and would be competitively harmful if publicly disclosed.

 

Exhibit 10.2

 

 

AMENDMENT AGREEMENT

 

 

SYNDAX PHARMACEUTICALS INC

35 Gatehouse Drive

Building D, Floor 3

Waltham, 

Massachusetts 02451, USA

 

Attention: President

 

3rd July 2019

 

Dear Sirs

 

LICENSE AGREEMENT BETWEEN UCB BIOPHARMA SPRL (“UCB”) AND SYNDAX PHARMACEUTICALS INC (“Syndax”) DATED 1 JULY 2016 (“Agreement”)

 

We refer to the Agreement entered into by UCB and Syndax under which UCB granted Syndax certain license rights to develop and commercialize products containing UCB6352 (now referred to by Syndax as SNDX6352).

To the extent not explicitly defined herein, capitalised terms used in this Amendment Agreement (this “Amendment”) shall have the same meaning as set forth in the Agreement. Any reference to a Section shall be to a section of the Agreement, unless expressly specified otherwise. 

Background

Syndax has requested an extension of the deadline by when clinical development of the Compound [*] shall commence (as set forth in Section 6.3.2), and UCB is prepared to agree to such an extension on a one-off basis on certain terms and conditions. The Parties therefore wish to record the terms and conditions on which such extension shall be granted by UCB in the form of this Amendment in accordance with Section 12.6. 

Variation  

 

In consideration of the mutual promises set out in this Amendment, and with effect from 30th June 2019, the Parties agree to amend the Agreement as follows: 

	
 
	
1.1.
	
Section 6.3.2 shall be deleted in its entirety and replaced with the following:

“Commence clinical development of the Compound [*] from the Effective Date;”

 

	
 
	
1.2.
	
A new Section 6.8 shall be inserted after Section 6.7:

“Right to Extend. Without prejudice to Section 6.4 (Right to Terminate), the Company may request an extension of the [*] set forth in Section 6.3.2 (“[*]”), subject to the prior written consent of UCB. In the event that an extension is approved by UCB beyond the [*], interest shall be payable by the Company at the same time as, and on the full value of, [*] (as described in Section 4.2), such interest to be calculated at the rate set forth in Section 4.12 as accrued from the date of the [*] until the date of payment of such [*] by the Company.” 

Miscellaneous

This Amendment, together with the Agreement, constitutes the entire agreement between the Parties with 

respect to the subject matter contained therein, and together, supersedes and replaces any and all prior and contemporaneous understandings, arrangements and agreements, whether written or oral, with respect to the subject matter.

This Amendment Agreement constitutes Confidential Information of both Parties, governed by the terms of the Agreement.

Except as otherwise expressly stated herein, all terms and conditions of the Agreement shall remain unchanged and in full force and effect.

This Amendment may be executed in any number of counterparts and by the Parties on separate counterparts, each of which is an original but all of which together constitute one and the same instrument. Electronically executed or electronically transmitted signatures (including via fax or by email in “.pdf” format) shall have the full force and effect of original signatures.

This Amendment and any non-contractual obligations arising in connection with it shall be governed and construed in accordance with the laws of the State of New York, without regard to its conflict of law principles. 

Please acknowledge receipt of this Amendment and confirm your acceptance of its contents by signing and returning to us the enclosed duplicate of this Amendment. 

 

Yours sincerely

 

 

 

UCB BIOPHARMA SPRL

 

Signed: /s/ [*]

Name: [*]

Title: [*]

 

 

Acknowledgement and Agreement

Receipt of this Amendment is acknowledged by us and we hereby agree to the terms of the Amendment in accordance with the terms set out above.

 

For and on behalf of

SYNDAX PHARMACEUTICALS INC

Name: /s/ Luke J. Albrecht

Title: General Counsel

Date: July 9, 2019

 

2

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