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SEC Filings

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

If after submission by or on behalf of Seres of the Protocol Amendment for the 3‑Arm SER‑287 Clinical Trial to the FDA, (i) the FDA provides feedback indicating that the 3‑Arm SER‑287 Clinical Trial could be used as one of the two necessary Phase III Clinical Trials for the First IBD Product for the treatment of UC (i.e. the data from the 3‑Arm SER‑287 Trial, if statistically compelling, could be used in a BLA submission as one of two such Phase III Clinical Trials) and (ii) the results of the 3‑Arm SER‑287 Clinical Trial demonstrate statistically significant efficacy with respect to the Lower Dose only to the extent that such results would make such 3‑Arm SER‑287 Clinical Trial constitute only a Phase II Clinical Trial (i.e.  two additional Phase III Clinical Trials for the First IBD Product for the treatment of UC are still required to be conducted for a BLA submission therefor), then [***] and the Development Costs of both of the Phase III Clinical Trials which are additionally required to be conducted shall be shared by Seres and NHSc pursuant to Section 4.8.1(b) of the Agreement.

h)

If after submission by or on behalf of Seres of the Protocol Amendment for the 3‑Arm SER‑287 Clinical Trial to the FDA, (i) FDA provides feedback indicating that the 3‑Arm SER‑287 Clinical Trial could be used as one of the two necessary Phase III Clinical Trials for the First IBD Product for the treatment of UC (i.e.  the data from the 3‑Arm SER‑287 Trial, if statistically compelling, could be used in a BLA submission as one of two such Phase III Clinical Trials) and (ii) the results of the 3‑Arm SER‑287 Trial do not demonstrate statistically significant efficacy of the Lower Dose, then (X) [***] and (Y) [***]

i)

[***]

j)

Notwithstanding the foregoing provisions of this Letter Agreement, if NHSc after a commercial viability assessment decides in its sole discretion to launch in the EU a First IBD Product for the treatment of UC comprised of a higher dosage strength than the Lower Dose (“Commercial Viability Determination”), then within thirty (30) days after the Commercial Viability Determination, NHSc will pay to Seres the amount calculated by determining the amount NHSc would have paid under Section 4.8 of the Agreement to support Development Costs for Clinical Trials for the First IBD Product for the treatment of UC, without taking into account the terms and conditions of this Letter Agreement, and subtracting from such amount the amount of Development Costs previously paid by NHSc for the First IBD Product for UC by operation of the terms of this Letter Agreement.

k)

The Parties acknowledge that the terms and conditions of this Letter Agreement shall be treated as the Confidential Information of both Parties, subject to Article 11 of the Agreement.

l)

Except as expressly provided in this Letter Agreement, the Agreement shall continue in full force and effect.  This Letter Agreement, and the other terms and conditions of the Agreement, constitute the entire agreement of the Parties with respect to the subject matter hereof.

m)

This Letter Agreement may be executed in counterparts, each of which shall constitute an original and all of which shall together constitute a single agreement.  This Letter Agreement may be executed and delivered electronically, including via PDF format, and upon such delivery such electronic signature will be deemed to have the same effect as if the original signature had been delivered to the other Parties.

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*** 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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