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

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 not 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 Clinical Trial, even if it shows statistically compelling efficacy, could not 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 are sufficient to allow Seres to proceed to conduct the first of the two Phase III Clinical Trials in respect of the Lower Dose, then (X) [***] and (Y) Section 4.8 and Section 4.8.1(b) of the Agreement shall continue to apply with respect to the sharing of Development Costs for both the first and second Phase III Clinical Trials to be conducted by Seres for the First IBD Product for the treatment of UC.

e)

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 not 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, even if it shows statistically compelling efficacy, could not 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) all future Development Costs to be shared by the Parties pursuant to Section 4.8 of the Agreement will be shared as between Seres and NHSc pursuant to Sections 4.8.1(b) (IBD Products) and 4.8.2(c) (C Difficile Products) of the Agreement provided that, [***]

f)

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 to allow for Seres to conduct the second of the two Phase III Clinical Trials required for Regulatory Approval of the First IBD Product for the treatment of UC, then the Development Costs of the 3‑Arm SER‑287 Clinical Trial and the second of the two Phase III Clinical Trials required for Regulatory Approval shall be shared by Seres and NHSc pursuant to Section 4.8.1(b) of the Agreement, provided that [***]

3

*** 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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