Document:

mcrb-ex1022_331.htm

EXHIBIT 10.22

AMENDMENT #1 TO THE COLLABORATION AND LICENSE AGREEMENT

This AMENDMENT #1 TO THE COLLABORATION AND LICENSE AGREEMENT (the "Amendment") is entered into this tenth day of August, 2016 by and between NESTEC LTD., a limited company organized and existing under the laws of Switzerland, having an office located at Avenue Nestle 55, 1800 Vevey, Switzerland ("NHSc"), and Seres Therapeutics, Inc., a corporation incorporated and existing under the laws of the State of Delaware, having an office located at 200 Sydney Street, Cambridge MA 02139, USA ("Seres"). NHSc and Seres are sometimes referred to herein as the "Parties".

WHEREAS, the Parties entered into a COLLABORATION AND LICENSE AGREEMENT dated January 9, 2016 (the "Agreement") whereby Seres granted to NHSc certain licenses under intellectual property controlled by Seres relating to a new class of medicinal microbiome products to treat and manage inflammatory bowel disease, and treat and prevent the recurrence of C. difficile infections (the "Products"), outside the US and Canada;

WHEREAS, in the course of the collaboration under the Agreement, Seres conducted a Phase 2 study for the initial C. difficile product SER-109, and recently determined that the primary endpoint of such study was not achieved;

WHEREAS, Seres has begun to gather and analyze data relating to the Phase 2 study in order to make appropriate adjustments to the SER-109 development plan, and NHSc would like to assist Seres therewith;

WHEREAS, in order to facilitate NHSc so-assisting Seres, Seres will share with NHSc highly confidential information which the Parties agree will require a higher level of confidential treatment by NHSc than is currently provided for in ARTICLE 11 of the Agreement, and hence the Parties wish to provide for such higher level of confidential treatment in accordance with this Amendment, for this currently contemplated exchange of highly confidential information, and for potential future exchanges of other highly confidential information.

NOW, THEREFORE in consideration of the foregoing and the terms below, the Parties agree to amend the Agreement by adding the following new section 11.7 (capitalized terms below not defined herein shall have the meanings set forth in the Agreement):

	
 
	
11.7
	
Special Treatment of Highly Confidential Information. A Party may from time to time be in possession of information which such party desires to disclose to the other Party under more restrictive terms than otherwise provided for in this ARTICLE 11 ("Highly Confidential Information"). In such case, the party desiring to make such disclosure ("Disclosing Party") shall notify the other Party ("Receiving Party") in writing of the general category of information proposed to be so disclosed in order to allow the Receiving Party the opportunity to agree to receive the Highly Confidential Information from the Receiving Party under the terms of this section 11.7. If the Receiving Party elects not to receive such Highly Confidential Information on such terms, the Disclosing Party may elect to either not disclose the information at all, or to disclose the information under the terms of sections 11.1 through 11.6 of this ARTICLE 11. If the Receiving Party elects to receive such Highly Confidential Information under the terms of this section 11.7, then each Party shall select no more than four (4) people agreeable to the other Party to be participants in the exchange of, and discussions concerning, Highly Confidential Information ("Section 11.7 Participants") unless, on a case by case basis, the Parties agree in writing to a number greater than four (4). The Section 11.7 Participants shall agree upon a process to exchange and discuss Highly Confidential Information, and the Parties shall arrange for the recording of minutes of such exchanges and discussions. All such minutes, and other materials such as agendas, slide presentations, Webex content, handouts, etc. used as part of such exchanges and discussions, shall be clearly marked as "Highly Confidential Information", and all such materials including the information contained therein shall be held in strict confidence by the Section 11.7 Participants, including to the exclusion of other employees, agents and Affiliates of their respective Party. Each Section 11.7 Participant will promptly notify the other Party upon becoming aware of any use or disclosure of Highly Confidential Information not permitted pursuant to this section 11.7. Sections 11.1.1 and 11.2 shall not apply to Highly Confidential Information, and sections 11.4, 11.5 and 11.6 shall apply to Highly Confidential Information.

IN WITNESS WHEREOF, the Parties have caused this Amendment to be executed by their respective duly authorized officers.

 

	
SERES THERAPEUTICS, INC.

	
 
	
 
	
 

	
By:
	
 
	
/s/ Roger J. Pomerantz, M.D.

	
 
	
 
	
 

	
Name:
	
 
	
/s/ Roger J. Pomerantz, M.D., F.A.C.P.

	
 
	
 
	
 

	
Title
	
 
	
President, CEO and Chairman

 

 

	
NESTEC LTD.

	
 
	
 
	
 

	
By:
	
 
	
/s/ Claudio Vuoni

	
 
	
 
	
 

	
Name:
	
 
	
/s/ Claudio Vuoni

	
 
	
 
	
 

	
Title
	
 
	
General Counsel NHScmcrb-ex1023_291.htm

 

		
	
CONFIDENTIAL
	
EXHIBIT 10.23

 

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

 

NESTEC LTD.

Attention:  General Counsel, Nestlè Health Science

Avenue Nestle 55

1800 Vevey

Switzerland

October 30, 2018

This letter agreement (“Letter Agreement”) sets forth the agreement between NESTEC LTD.  (“NHSc”) and Seres Therapeutics, Inc. (“Seres”) (each of NHSc and Seres, a “Party”, and together, the “Parties”), pursuant to which certain terms of the Collaboration and License Agreement between Seres and NHSc dated January 9, 2016 (the “Agreement”) will be amended and clarified with respect to the conduct of a particular clinical study of the product designated as SER‐287.

Capitalized terms used but not defined herein shall have the meanings ascribed to them in the Agreement.

Notwithstanding anything to the contrary in the Agreement (including without limitation all Development Plans thereunder), the Parties hereby agree as follows, effective as of the date of this Letter Agreement (the “Letter Agreement Effective Date”):

	
a)
	
Seres recognizes that its obligation under Section 4.1 to use Diligent Efforts to Develop Collaboration Products and obtain approval of a BLA thereon in the European Union includes an obligation to Develop Products that are commercially viable, i.e., that such obligation should take into consideration the “profit potential” of Collaboration Products per the definition of Diligent Efforts in the Agreement.  [***]

 

 

	
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. 

 

	
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. 

 

	
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.

[Signature Page Follows]

4

*** 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. 

 

To agree that this Letter Agreement accurately reflects our mutual agreement, please execute and return to me a copy of this Letter Agreement.

 

	
By:
	
/s/ Roger J. Pomerantz

	
 
	
Roger J. Pomerantz, MD, FACP

	
 
	
President, CEO and Chairman

	
 
	
Seres Therapeutics, Inc.

 

 

Agreed to this    1    day of November, 2018

 

 

	
By:
	
/s/ Claudio Kuoni

	
 
	
 

	
Printed Name:
	
Claudio Kuoni

	
 
	
 

	
Title:
	
General Counsel Nestlé Health Science

NESTEC LTD.

 

5

*** 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.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00293-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00293-of-00352.parquet"}]]