EXHIBIT 10.1
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such omitted information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.
Execution Version
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (“Agreement”), dated as of July 1, 2021 (the “Effective Date”) is entered into between Seres Therapeutics, Inc., a corporation organized and existing under the laws of Delaware, having an office located at 200 Sidney Street, Cambridge, MA 02139, USA (“Seres”) and NHSc Pharma Partners, a simple partnership within the meaning of article 530 et seq. of the Swiss Code of Obligations, having an office located at Avenue Nestlé 55, 1800 Vevey, Switzerland (“Licensee”).
BACKGROUND
A. Seres owns or controls certain patents, know-how and other intellectual property relating to the product known as SER-109;
B. Licensee has experience in marketing and distributing pharmaceutical products;
C. Under the Existing Agreement (defined below), Seres has granted to Licensee certain exclusive rights and licenses for the exploitation of SER-109 outside of the United States and Canada; and
D. Seres is now willing to grant to Licensee, and Licensee desires to obtain, certain co-exclusive rights and licenses with respect to the commercialization of SER-109 in the United States and Canada.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
DEFINITIONS
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If any cost or expense is directly attributable or reasonably allocable to more than one activity, such cost or expense shall only be counted as an Allowable Expense with respect to one of such activities.
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In the case of sale or other disposal of Collaboration Products for non-cash consideration, the gross revenue attributable to such Collaboration Product for purposes of calculating Net Sales in respect thereof shall include the fair market price of such non-cash consideration. Notwithstanding the foregoing, provision of Collaboration Products for the purpose of [***] shall not be deemed to be a sale. For clarity, any consideration received for Collaboration Products [***] shall not be included in the calculation of Net Sales.
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Net Sales shall be determined in accordance with GAAP.
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GRANT OF LICENSE
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GOVERNANCE
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DEVELOPMENT AND REGULATORY ACTIVITIES
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COMMERCIALIZATION
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For clarity, the activities in Section 5.5(a)(i)-(xi) for a Collaboration Product shall be included in the Commercialization Plan and Budget for such Collaboration Product to the extent agreed by the JCC and, in the case of the initial Commercialization Plan and Budget, consistent with Exhibit E.
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Medical Affairs Activities
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PAYMENTS
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Milestone Event | Milestone Payment |
First Regulatory Approval by the FDA for the first Collaboration Product
| $125,000,000 |
First Regulatory Approval for the first Collaboration Product in Canada
| $10,000,000 |
Sales Milestone Events | Milestone Payment |
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First Calendar Year in which annual Net Sales of Collaboration Products in the Licensed Territory equal or exceed $250,000,000 | $50,000,000 |
First Calendar Year in which annual Net Sales of Collaboration Products in the Licensed Territory equal or exceed $500,000,000 | $75,000,000 |
First Calendar Year in which annual Net Sales of Collaboration Products in the Licensed Territory equal or exceed $750,000,000 | $100,000,000 |
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provided that, for the avoidance of doubt, consistent with Section 1.155, (A) income and withholding taxes imposed on either of the Parties or their Affiliates, (B) any payments made by Licensee to Seres pursuant to Section 7.1 or 7.2 and (C) indemnification payments by a Party to the other Party or to an Indemnitee hereunder or under the Supply Agreement, will not be included in the calculation of either Party’s Party Allowable Expenses or Receipts for any Calendar Quarter.
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PAYMENTS; BOOKS AND RECORDS
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PRODUCT MANUFACTURING AND SUPPLY
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CONFIDENTIALITY
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Any combination of features or disclosures shall not be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the rightful possession of the Receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the Receiving Party. Additionally, specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the Receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the Receiving Party.
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PATENT PROSECUTION AND ENFORCEMENT
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TRADEMARKS
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TERM AND TERMINATION
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EFFECTS OF TERMINATION; RIghts in lieu of termination
Unless otherwise expressly provided, Licensee’s costs to effect a smooth termination of the Agreement pursuant to this Section 14.2(a) shall be borne by [***]; otherwise such costs shall be borne by [***] unless otherwise expressly provided.
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REPRESENTATIONS, WARRANTIES AND COVENANTS
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INDEMNIFICATION and insurance
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DISPUTE RESOLUTION
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GENERAL PROVISIONS
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To Seres: Seres Therapeutics, Inc. 200 Sidney Street Cambridge, MA 02139
Attention:
| To Licensee: NHSc Pharma Partners 55 Avenue Nestle 1800 Vevey, Switzerland Email: [***] Attention: [***] |
With a copy to (which shall Latham & Watkins LLP 200 Clarendon Street Boston, MA 02116 Attention: [***] | With a copy to (which shall Mayer Brown LLP Attention: [***] |
Any notice required or permitted to be given concerning this Agreement shall be effective upon receipt by the Party to whom it is addressed.
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[Signature Page Follows]
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.
Seres Therapeutics, Inc.
BY: /s/ Eric D. Shaff
NAME: Eric D. Shaff
TITLE: CEO
NHSc Pharma Partners
By: Société des Produits Nestlé S.A,
Its: Managing Partner
BY: [***]
NAME: [***]
TITLE: [***]
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EXHIBIT A
FTE RATES
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EXHIBIT B
LICENSED PATENTS
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EXHIBIT C
DEVELOPMENT AND REGULATORY ACTIVITY PLAN
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EXHIBIT D
PRE-LAUNCH PLAN
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EXHIBIT E
SER-109 LAUNCH PLAN AND BUDGET
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EXHIBIT F
TERMS OF SUPPLY AGREEMENT
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EXHIBIT G
PRESS RELEASE
SERES THERAPEUTICS, NESTLÉ HEALTH SCIENCE ANNOUNCE
SER-109 CO-COMMERCIALIZATION LICENSE AGREEMENT
CAMBRIDGE, Mass. and LAUSANNE, Switzerland -- July 1, 2021 -- Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, announced today that it has entered into an agreement with Nestlé Health Science to jointly commercialize SER-109, Seres’ investigational oral microbiome therapeutic for recurrent Clostridioides difficile infection (CDI), in the United States (U.S.) and Canada. If approved, SER-109 would become the first-ever FDA-approved microbiome therapeutic.
Under the terms of the agreement, Nestlé Health Science will utilize its global pharmaceutical business Aimmune Therapeutics and will assume the role of lead commercialization party. Seres will receive license payments of $175 million up front, and an additional $125 million upon FDA approval of SER-109. The agreement also includes sales target milestones which, if achieved, could total up to $225 million. Seres will be responsible for development and pre-commercialization costs in the U.S. Upon commercialization, Seres will be entitled to an amount equal to 50% of the commercial profits.
The agreement to co-commercialize SER-109 in the U.S. and Canada represents the expansion of an existing strategic collaboration between the companies. Nestlé Health Science already has commercial rights to Seres’ investigational treatments for CDI and inflammatory bowel disease outside of the U.S. and Canada, and with this expansion, Nestlé Health Science becomes Seres’ global collaborator in SER-109.
A leading cause of hospital-acquired infections in the U.S., CDI is associated with debilitating diarrhea and claims the lives of more than 20,000 Americans each year. SER-109 is comprised of purified Firmicutes spores, based on their modulatory role in the life cycle of C. difficile and disease pathogenesis. The bacterial consortium in SER-109 rapidly repopulates the microbiome in the gut to produce compositional and functional changes that are critical to a sustained clinical response.
“Nestlé Health Science has been a terrific collaborator in our quest to develop a new treatment option for patients suffering from recurrent C. difficile infection, and their support over the past few years has been critical in advancing SER-109 to address this unmet need,” Seres Therapeutics CEO, Eric Shaff, said. "We conducted a competitive process to select a collaborator for SER-109. As we prepare for potential approval and commercialization, we are
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eager to embark side-by-side on our next phase with a company that believes as fervently as we do in the potential of this transformative approach to reduce the recurrence of CDI.”
“We are excited to expand our existing collaboration with Seres Therapeutics at this pivotal time, given the promise SER-109 holds for patients trapped in the debilitating cycle of recurrent C. difficile infection,” CEO of Nestlé Health Science, Greg Behar, added. “Nestlé Health Science is focused on the fast-developing areas of gut health, food allergies and metabolic health within our global pharmaceutical business, Aimmune Therapeutics. We look forward to leveraging Aimmune’s existing, fully integrated commercial infrastructure and capability to launch this important medicine, once approved.”
Nestlé Health Science continues to make significant investments in innovation while leveraging leading-edge science. Its pharma arm, Aimmune Therapeutics, has a strong presence in the field of gastroenterology, allowing it to lead the commercialization of SER-109 while providing Seres the ability to retain a strategic role and actively participate in the launch.
SER-109 Clinical & Regulatory Milestones
Responsibility for oversight of activities to support SER-109 will be governed by a Joint Steering Committee composed of an equal number of members from each company. Seres is responsible for the manufacturing and supply of SER-109 for all geographies contemplated in the collaboration in addition to ex-North America. Seres will lead medical affairs activities pre-launch and Aimmune Therapeutics will lead commercialization and medical affairs activities post-launch.
Conference Call Information
Seres’ management team will host a conference call today, July 1, 2021, at 8:30 a.m. ET. To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 5382249. To join the live webcast, please visit the “Investors and News” section of the Seres website at www.serestherapeutics.com.
A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.
About Seres Therapeutics
Seres Therapeutics, Inc., (Nasdaq: MCRB) is a leading microbiome therapeutics company
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developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Seres’ SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic. Seres’ SER-287 program has obtained Fast Track and pediatric Orphan Drug Designations from the FDA and is being evaluated in a Phase 2b study in patients with active mild-to-moderate ulcerative colitis. Seres is evaluating SER-301 in a Phase 1b study in patients with ulcerative colitis and SER-155 in a Phase 1b study to address gastrointestinal infections, bacteremia and graft-versus-host disease. For more information, please visit www.serestherapeutics.com.
About Nestlé Health Science and Aimmune Therapeutics
Nestlé Health Science, a leader in the science of nutrition, is a globally managed business unit of Nestlé. We are committed to redefining the management of health, offering an extensive portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and supplement brands. Our extensive research network provides the foundation for products that empower healthier lives through nutrition. Headquartered in Switzerland, we have more than 7,000 employees around the world, with products available in more than 140 countries. www.nestlehealthscience.com
Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening gastrointestinal, metabolic, and food-mediated allergic conditions. www.aimmune.com
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including our development plans; the timing and results of the SER-109 safety data; the ability of our clinical trials to support approval of SER-109; the size of the market for SER-109; our ability to achieve the targets and receive any milestones payments from Nestlé Health Science; Nestlé Health Science’s obligation to share responsibility and costs for the commercialization of SER-109; and the potential benefits of our collaboration with Nestlé Health Science.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; the impact of the COVID-19 pandemic; our unproven approach to therapeutic intervention; the lengthy, expensive and uncertain process of clinical drug development; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates and develop and commercialize our product candidates, if approved; and our ability to retain key personnel and to manage our growth. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on May 4, 2021, and our other reports filed with the SEC could cause
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actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Seres Therapeutics:
PR Contact
Kristin Ainsworth
kainsworth@serestherapeutics.com
IR Contact
Carlo Tanzi, Ph.D.
ctanzi@serestherapeutics.com
Nestlé Health Sciences:
PR/IR Contact:
Jacquelyn Campo
Jacquelyn.Campo@Nestle.com
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