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SEC Filings

10-K
SERES THERAPEUTICS, INC. filed this Form 10-K on 03/06/2019
Entire Document
 

 

b)

Upon commencement of the 3‑Arm SER‑287 Clinical Trial (as defined below), NHSc shall pay to Seres an amount equal to forty million US dollars ($40,000,000) (the “Total Phase II/III SER‑287 Milestone Payment”) in connection with the following two milestone payments set forth in the Agreement as listed as the first and second milestone payments in the table in Section 8.2.1 of the Agreement (respectively, the “Applicable Milestone Payments”, and the “Applicable Milestone Events”):

 

Applicable Milestone Event

Applicable Milestone Payment

Commencement of a Phase II Clinical Trial, as contemplated in the Global Development Plan, in respect of the First IBD Product for UC (Induction).

$20,000,000

Commencement of a Phase III Clinical Trial, as contemplated in the Global Development Plan, in respect of the First IBD Product for UC (Induction).

$20,000,000

 

In the event the 3‑Arm SER‑287 Clinical Trial commences before December 15, 2018, NHSc will pay the Total Phase II/III SER‑287 Milestone Payment before December 31, 2018.  In the event the 3‑Arm SER‑287 Clinical Trial commences between December 16, 2018 and December 27, NHSc will use commercially reasonable efforts to pay the Total Phase II/III SER‑287 Milestone Payment before December 31, 2018.  In order to facilitate logistics of such a payment, Seres will regularly inform NHSc about the expected commencement of the 3‑Arm SER‑287 Clinical Trial.  For clarity, the Applicable Milestone Payments for the achievement of the Applicable Milestone Events set forth in this paragraph b) shall replace the first and second milestone payments that are set forth in Section 8.2.1 of the Agreement, upon Seres’s receipt of the Total Phase II/III SER‑287 Milestone Payment.

c)

Seres shall conduct a Clinical Trial with respect to the First IBD Product for the treatment of UC, which Clinical Trial will consist of three (3) arms, 67 patients per arm for a total of 201 subjects, the arms being P/P, [***] in accordance with the protocol therefor as to be approved by the JSC (the “Protocol Amendment”) (the “3‑Arm SER‑287 Clinical Trial”).  The JSC shall update the applicable Development Plan to account for the conduct of the 3‑Arm SER‑287 Clinical Trial by Seres promptly after the Letter Agreement Effective Date.  For purposes of this Letter Agreement, the treatment arm of the 3‑Arm SER‑287 Clinical Trial designed to include a [***] of the First IBD Product shall be referred to herein as the “Lower Dose”.

2

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.



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