Exhibit 10.26
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.
LICENSE AGREEMENT
by and between
GFB (ABC), LLC or its successor in interest
and
KARUNA THERAPEUTICS, INC.
TABLE OF CONTENTS
Page
Article I Definitions 1
Article II Grant of Rights; Exclusivity 14
Section 2.1 License Grant 14
Section 2.2 Sublicense Rights 14
Section 2.3 Affiliates and Sublicensees 14
Section 2.4 No Implied Licenses or Rights 14
Section 2.5 Section 365(n) of the Bankruptcy Code 14
Article III Technology Transfer 15
Section 3.1 Tech Transfer 15
Section 3.2 Support 15
Section 3.3 Costs 15
Article IV Development, Manufacturing, Commercialization, and Regulatory Affairs 15
Section 4.1 General 15
Section 4.2 Diligence 15
Section 4.3 Development and Commercialization Plans 15
Section 4.4 Progress Reports 16
Section 4.5 Regulatory Documentation and Regulatory Interactions 16
Article V Financial Provisions 17
Section 5.1 Upfront Fee 17
Section 5.2 Milestone Payments 17
Section 5.3 Royalty Payments 19
Section 5.4 Non-Royalty Sublicense Consideration Payments 21
Section 5.5 Financial Records 21
Section 5.6 Audits 21
Section 5.7 Tax Matters 22
Section 5.8 Foreign Derived Intangible Income Deduction 23
Section 5.9 Currency Exchange 23
Section 5.10 Late Payments 23
Section 5.11 Blocked Payments 23
Section 5.12 Prohibitions on Payments 23
Article VI Intellectual Property 24
Section 6.1 Prosecution of Patents 24
Section 6.2 Third Party Infringement 24
Section 6.3 Claimed Invalidity 25
Section 6.4 Patent Term Extensions 26
Section 6.5 Patent Marking 26
Article VII Confidentiality 26
Section 7.1 General 26
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Section 7.2 Permitted Disclosure 26
Section 7.3 Publicity; Terms of this Agreement 27
Section 7.4 Term 27
Section 7.5 Return of Confidential Information 27
Section 7.6 Vicarious Responsibility 28
Article VIII Representations and Warranties 29
Section 8.1 Mutual Representations 29
Section 8.2 Additional GFB Representations 29
Section 8.3 Covenants 31
Section 8.4 Disclaimer 31
Article IX Indemnification; Insurance 31
Section 9.1 By Karuna 31
Section 9.2 By GFB 32
Section 9.3 Indemnification Procedures 32
Section 9.4 Limitation of Liability 33
Article X Term and Termination 33
Section 10.1 Term 33
Section 10.2 Termination 33
Section 10.3 Effects of Termination 35
Section 10.4 Survival 37
Section 10.5 Other Relief 37
Article XI Miscellaneous 37
Section 11.1 Dispute Resolution 37
Section 11.2 Submission to Court for Resolution; Waiver of Jury Trial 37
Section 11.3 Governing Law 37
Section 11.4 Assignment 38
Section 11.5 Force Majeure 38
Section 11.6 Notices 38
Section 11.7 Waiver 39
Section 11.8 Severability 39
Section 11.9 Entire Agreement 39
Section 11.10 Modification 40
Section 11.11 Independent Contractor 40
Section 11.12 Interpretation; Construction 40
Section 11.13 Counterparts 40
Section 11.14 Equitable Relief 41
Section 11.15 Further Assurances 41
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TABLE OF CONTENTS
(continued)
Page
Exhibits
Exhibit A Initial Development Plan
Schedules
Schedule 1.45 GFB-887
Schedule 7.3(a) Joint Press Release
Schedule 8.2(k) Licensed Compounds and Licensed Patents
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LICENSE AGREEMENT
This License Agreement (this “Agreement”) is entered into as of January 31, 2023 (the “Effective Date”), by and between GFB (ABC), LLC, a Delaware limited liability company, or its successor in interest (collectively, “GFB”) and Karuna Therapeutics, Inc. (“Karuna”). Karuna and GFB are each referred to herein by name or as a “Party”, or, collectively, as the “Parties”.
INTRODUCTION
WHEREAS, Karuna, among other things, conducts programs to discover, develop, manufacture, and commercialize innovative therapeutic products for the treatment and prevention of diseases;
WHEREAS, on January 6, 2023, Goldfinch Bio, Inc., a Delaware corporation (“Goldfinch”) and GFB (ABC), LLC entered into a certain General Assignment by which Goldfinch assigned all of its right, interest and title to all of its assets to GFB (ABC), LLC (the “General Assignment”);
WHEREAS, in connection with the General Assignment, Goldfinch and GFB (ABC), LLC executed a certain Patent Assignment Agreement (the “Patent Assignment”) and Trademark Assignment Agreement (the “Trademark Assignment,” and, together with the Patent Assignment and General Assignment, the “Assignments”) on even date thereof. The execution of the Assignments resulted in the creation of the Goldfinch Assignment Estate (the “Assignment Estate”);
WHEREAS, on January 17, 2023, GFB (ABC), LLC initiated an assignment for the benefit of creditor proceeding in the Court of Chancery of the State of Delaware with the filing of a Verified Petition for Assignment for the Benefit of Creditors (In re Goldfinch Bio, Inc., Case No. 2023-0045) pursuant to 10 Del. C. §§7381-7387 (the “ABC Proceeding”);
WHEREAS, GFB, or its predecessor in interest, has developed the Licensed Compounds and Licensed Products (each, as defined below) and owns or Controls certain Know-How and Patents (each as defined below) related thereto; and
WHEREAS, Karuna desires to obtain, and GFB desires to grant to Karuna, an exclusive license under such Know-How and Patents to develop, manufacture, and commercialize the Licensed Compounds and Licensed Products (as defined below) in accordance with the terms and subject to conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the respective representations, warranties, covenants, and agreements contained herein, and for other valuable consideration, the receipt and adequacy of which are hereby acknowledged, GFB and Karuna hereby agree as follows:
IF " DOCVARIABLE "SWDocIDLocation" 1" = "1" " DOCPROPERTY "SWDocID" ACTIVEUS 197546146v.17" "" [***] = Certain Confidential Information Omitted
Definitions
When used in this Agreement, each of the following terms shall have the meanings set forth in this Article I:
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For clarity, GFB is not granting any license to Karuna with respect to any compound included in a Licensed Product that is not a Licensed Compound.
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There shall be no double counting in determining the foregoing deductions from gross amounts invoiced to calculate “Net Sales” hereunder. The calculations set forth in this definition shall be determined in accordance with Accounting Standards.
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If non-monetary consideration is received by a Selling Party for any Licensed Product in a relevant country, Net Sales will be [***].
Notwithstanding anything to the contrary in this definition, Net Sales will not include [***].
Net Sales shall be determined on, and only on, the first sale by a Selling Party to a non-Selling Party Third Party.
If a Licensed Product is sold as part of a Combination Product (as defined below), Net Sales will be [***].
As used in this definition of “Net Sales,” “Combination Product” means a Licensed Product that is sold for a single price with one or more additional active ingredients (whether co-formulated or co-packaged) that are not Licensed Products.
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Grant of Rights; Exclusivity
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Technology Transfer
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Development, Manufacturing, Commercialization, and Regulatory Affairs
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Financial Provisions
Milestones | Payment (in US Dollars) | |
| First Indication | Second Indication |
(i) [***] | [***] | [***] |
(ii) [***] | [***] | [***] |
(iii) [***] | [***] | [***] |
(iv) [***] | [***] | [***] |
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Milestones | Payment (in US Dollars) |
First time worldwide Annual Net Sales of such Licensed Product meet or exceed [***] | [***] |
First time worldwide Annual Net Sales of such Licensed Product meet or exceed [***] | [***] |
First time worldwide Annual Net Sales of such Licensed Product meet or exceed [***] | [***] |
First time worldwide Annual Net Sales of such Licensed Product meet or exceed [***] | [***] |
First time worldwide Annual Net Sales of such Licensed Product meet or exceed [***] | [***] |
If more than one of the milestone events under this Section 5.2(b) is first achieved in the same Calendar Quarter, then (i) only the largest of the corresponding milestone payments under this Section 5.2(b) shall be paid for such Calendar Quarter, but (ii) if any of the other (i.e., any of the lesser) milestone events that were first achieved in such Calendar Quarter is again achieved in a subsequent Calendar Quarter, then the milestone payment corresponding to such lesser milestone event shall be paid for such subsequent Calendar Quarter.
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Intellectual Property
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Confidentiality
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Notwithstanding the return or destruction of the Disclosing Party’s (and its Affiliates’) Confidential Information, the Receiving Party shall continue to be bound by its obligations of confidentiality and other obligations under this Article VII.
Representations and Warranties
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Indemnification; Insurance
in each case ((a)-(c)), except to the extent that GFB has an indemnification obligation pursuant to Section 9.2 for such Damages, as to which Damages each Party shall indemnify the other Party to the extent of such Party’s respective fault for such Damages.
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in each case ((a)-(c)), except to the extent that Karuna has an indemnification obligation pursuant to Section 9.1 for such Damages, as to which Damages each Party shall indemnify the other Party to the extent of such Party’s fault for such Damages.
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Term and Termination
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Miscellaneous
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To GFB: GFB (ABC), LLC 1738 Belmar Blvd. Belmar, NJ 07719 Attn: [***] | To Karuna: Karuna Therapeutics, Inc. 99 High Street, Floor 26, Boston, Massachusetts 02110 Attn: [***] |
With a copy, which shall not constitute notice, to: Thompson Hine LLP Telephone: [***]
| With a copy, which shall not constitute notice, to: WilmerHale 60 State Street Boston, MA 02109 Attention: [***] Telephone: [***] Facsimile: [***] |
Any such notices shall be effective upon receipt by the Party to whom it is addressed.
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.
GFB (ABC), LLC or its successor in interest
By: /s/ James E. Gansman___________
Name: James E. Gansman
Title: President
KARUNA THERAPEUTICS, INC.
By: /s/ Bill Meury__________________
Name: Bill Meury
Title: President and Chief Executive Officer
License Agreement
Signature Page
Exhibit A
Initial Development Plan
[***]
A-1
Schedule 1.45
GFB-887
[***]
7.3(a)-1
Schedule 7.3(a)
Joint Press Release
Karuna Therapeutics Announces Exclusive Global License Agreement for Goldfinch Bio’s Investigational TRPC4/5 Product Candidates
Karuna to obtain exclusive global license to develop, manufacture, and commercialize multiple TRPC4/5 candidates, including lead clinical-stage candidate GFB-887
Goldfinch Bio assignment estate to receive $15 million upfront payment and up to $520 million in potential milestone payments plus royalties for each TRPC4/5 candidate
Karuna to share details on the planned development of GFB-887 for the treatment of mood and anxiety disorders in the second half of 2023
BOSTON, Mass.– MONTH DAY, 2023 -- Karuna Therapeutics, Inc. (NASDAQ: KRTX) and GFB (ABC), LLC, assignee of the Goldfinch Bio assignment estate, today announced their entry into an exclusive license agreement under which Karuna will obtain global development, manufacturing, and commercialization rights to Goldfinch Bio’s investigational transient receptor potential canonical 4 and 5 (TRPC4/5) channel candidates, including lead clinical-stage candidate GFB-887. Karuna intends to evaluate these candidates as potential treatments for various psychiatric and neurological conditions, starting with GFB-887 for the treatment of mood and anxiety disorders. Karuna expects to share details on the planned development of GFB-887 in the second half of 2023.
“We are focused on addressing the substantial need for new and better treatments in psychiatry through identifying and developing mechanistically novel and distinct medicines,” said Bill Meury, president and chief executive officer of Karuna. “We believe that the TRPC4/5 mechanism could represent a completely novel approach to treating mood and anxiety disorders and complements our existing pipeline of differentiated potential medicines. This agreement aligns with our strategic goal to become a fully integrated neuroscience company with treatments that could offer much more than just incremental benefits to patients, and we look forward to sharing next steps for the program later this year.”
“We are incredibly excited to expand and diversify our development efforts and are encouraged about the potential of TRPC4/5 inhibitors to treat both mood and anxiety disorders based pre-clinical and clinical data demonstrating anxiolytic and antidepressant properties of these
7.3(a)-1
inhibitors,” said Steve Paul, M.D., president of research & development and chief scientific officer. “Our lead candidate in the TRPC4/5 program, GFB-887, has already demonstrated a compelling safety profile in non-clinical and clinical studies. We are fortunate to have found as advanced a clinical stage drug candidate directed against these important CNS targets and we will now study GFB-887 in various mood and anxiety disorders where there remains a significant unmet medical need for mechanistically novel medicines.”
Under the terms of the agreement, the assignment estate of Goldfinch Bio will receive a $15 million upfront payment and is eligible to receive up to $520 million in milestone payments for each licensed TRPC4/5 candidate, of which $410 million are related to regulatory approval and commercial sales milestones, as well as a flat low-single-digit royalty on any potential global net sales of each licensed product.
“GFB-887 demonstrated compelling benefits in preclinical models of mood and anxiety disorders, and we are delighted that Karuna will leverage its well-established expertise in developing medicines for psychiatric disorders to advance our TRPC4/5 candidates,” commented Anthony Johnson, M.D., president and chief executive officer of Goldfinch Bio. “I am tremendously grateful to all the patients and investigators, and Goldfinch Bio employees, advisors and investors who contributed to progressing GFB-887 and our other TRPC4/5 candidates to this point. It’s my sincere hope that these important contributions will lead to innovative new medicines for patients in need.”
Goldman Sachs & Co. LLC and Cowen served as financial advisors, and Ropes & Gray provided legal counsel to Goldfinch Bio.
About Karuna
Karuna Therapeutics is a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions. At Karuna, we understand there is a need for differentiated and more effective treatments that can help patients navigate the challenges presented by these severe and disabling disorders. Utilizing our extensive knowledge of neuroscience, we are harnessing the untapped potential of the brain in pursuit of novel pathways to develop medicines that make meaningful differences in peoples’ lives. For more information, please visit www.karunatx.com.
Karuna Therapeutics Forward Looking Statements
7.3(a)-2
This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the potential of the TRPC4/5 program, including GFB-887, to treat mood and anxiety disorders, our goals to develop and commercialize our product candidates and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our ability to generate positive clinical trial results for our product candidates and other risks inherent in clinical development, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, and other risks set forth under the heading “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2021. Our actual results could differ materially from the results described in or implied by such forward looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.
Karuna Therapeutics Contacts:
Investors:
Alexis Smith
518-338-8990
asmith@karunatx.com
Media:
Bob Josefsberg
bjosefsberg@karunatx.com
646-734-3584
Goldfinch Bio Contact:
Kyle Kuvalanka
kkuvalanka@goldfinchbio.com
7.3(a)-3
Schedule 8.2(k)
Licensed Compounds and Licensed Patents
Licensed Patents:
[***]
Licensed Compounds:
GFB-887, [***], and all other named compounds specifically or generically claimed in or Covered by any of the Patents listed above, including the following:
[***]