Exhibit 10.1
Certain identified information has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential. Information that was omitted has been noted in this document with a placeholder identified by the mark “[***]”.
EXCLUSIVE LICENSE AGREEMENT
between
disc medicine, inc.
and
MABWELL THERAPEUTICS, INC.
Entered into as of January 19, 2023
Table of Contents
Page | ||
1. | DEFINITIONS | 1 |
2. | DEVELOPMENT AND COMMERCIALIZATION | 19 |
2.1 | Diligence Obligations. | 19 |
2.2 | Development and Commercialization Responsibilities. | 20 |
2.3 | Development and Commercialization Costs | 21 |
2.4 | Development and Commercialization Records | 22 |
2.5 | Joint Steering Committee. | 22 |
2.6 | Alliance Managers | 25 |
3. | REGULATORY MATTERS | 25 |
3.1 | Notification of Clinical Trial Initiations | 25 |
3.2 | Regulatory Documentation and Results. | 25 |
3.3 | Recalls, Suspensions, and Withdrawals. | 27 |
3.4 | Safety Databases. | 28 |
3.5 | Adverse Event Reporting | 29 |
4. | TECHNOLOGY AND REGULATORY TRANSFER, MANUFACTURING, AND SUPPLY | 29 |
4.1 | Transfer of Licensed Know-How and Licensed Materials. | 29 |
4.2 | Transfer of Arising Know-How and Joint Improvement Know-How by Disc. | 30 |
4.3 | Transfer of Regulatory Documentation and Results | 30 |
4.4 | Supply of Licensed Antibody for Phase I Clinical Trial. | 30 |
4.5 | Manufacture and Technology Transfer and Licensed Materials. | 32 |
5. | GRANT OF RIGHTS | 32 |
5.1 | Disc Exclusive License to Licensed IP | 32 |
5.2 | Mabwell Retained Rights | 32 |
5.3 | Mabwell License to Arising IP and Joint Improvement IP | 33 |
5.4 | Disc Retained Rights | 33 |
5.5 | Rights of Reference and Right to Use Results. | 33 |
5.6 | Disc License to Licensed Materials | 34 |
5.7 | Sublicenses Under Rights of Reference | 34 |
5.8 | Sublicensees Generally | 34 |
5.9 | Exclusivity | 35 |
5.10 | No Implied Licenses | 36 |
5.11 | Restrictions on Encumbrances | 36 |
6. | PAYMENTS AND RECORDS | 36 |
6.1 | Upfront Payment | 36 |
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Table of Contents
(continued)
Page | ||
6.2 | Milestone Payments. | 36 |
6.3 | Royalties. | 39 |
6.4 | Sublicense Revenue | 41 |
6.5 | Mode of Payment; Offsets | 42 |
6.6 | Taxes. | 42 |
6.7 | Interest on Late Payments | 43 |
6.8 | Financial Records | 44 |
6.9 | Audit | 44 |
6.10 | Audit Dispute | 45 |
7. | INTELLECTUAL PROPERTY | 45 |
7.1 | Ownership of Intellectual Property. | 45 |
7.2 | Maintenance and Prosecution of Patents. | 46 |
7.3 | Enforcement and Defense of Licensed Patents and Licensed Know-How. | 48 |
7.4 | Infringement Actions by Third Parties | 50 |
7.5 | Third Party IP Rights | 50 |
8. | CONFIDENTIALITY AND NON-DISCLOSURE | 51 |
8.1 | Confidentiality and Non-Use Obligations | 51 |
8.2 | Permitted Disclosures | 52 |
8.3 | Use of Name | 53 |
8.4 | Public Announcements | 54 |
8.5 | Publications | 54 |
8.6 | Return of Confidential Information | 55 |
8.7 | Duration of Confidentiality and Non-Use Obligations | 55 |
8.8 | Privileged Communications | 55 |
8.9 | Supersession of Existing Confidential Disclosure Agreement | 55 |
9. | REPRESENTATIONS, WARRANTIES, AND COVENANTS | 56 |
9.1 | Mutual Representations and Warranties | 56 |
9.2 | Additional Representations and Warranties of Mabwell | 56 |
9.3 | Additional Representations and Warranties of Disc | 58 |
9.4 | Mutual Covenants | 59 |
9.5 | DISCLAIMER OF WARRANTIES | 59 |
9.6 | ADDITIONAL WAIVERS | 59 |
10. | INDEMNITY, LIMITATION OF LIABILITY, AND INSURANCE | 59 |
10.1 | Indemnification of Mabwell | 59 |
10.2 | Indemnification of Disc | 60 |
10.3 | Indemnification Procedures. | 60 |
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Table of Contents
(continued)
Page | ||
10.4 | Special, Indirect and Other Losses | 61 |
10.5 | Insurance | 61 |
11. | TERM AND TERMINATION | 62 |
11.1 | Term and Expiration | 62 |
11.2 | Termination. | 62 |
11.3 | Rights in Bankruptcy | 64 |
11.4 | Consequences of Termination | 64 |
11.5 | Disc Continuation in Lieu of Termination | 65 |
11.6 | Product Reversion | 65 |
11.7 | Remedies | 67 |
11.8 | Accrued Rights; Surviving Obligations | 67 |
12. | CLOSING CONDITION | 68 |
12.1 | General | 68 |
12.2 | Closing Condition | 68 |
12.3 | Disclosures Prior to Mabwell Shareholder Approval | 68 |
13. | MISCELLANEOUS | 69 |
13.1 | Force Majeure | 69 |
13.2 | Export Control | 69 |
13.3 | Assignment and Delegation | 69 |
13.4 | Severability | 69 |
13.5 | Dispute Resolution. | 70 |
13.6 | Governing Law, Jurisdiction and Service. | 71 |
13.7 | Notices. | 71 |
13.8 | Entire Agreement; Amendments | 72 |
13.9 | English Language | 73 |
13.10 | Equitable Relief | 73 |
13.11 | Waiver and Non-Exclusion of Remedies | 73 |
13.12 | No Benefit to Third Parties | 73 |
13.13 | Further Assurance | 73 |
13.14 | Relationship of the Parties | 74 |
13.15 | References | 74 |
13.16 | No Strict Construction; Interpretation | 74 |
13.17 | Counterparts | 75 |
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Schedule Listing
Schedule 1.91 | – | Licensed Materia |
Schedule 1.92 | – | Licensed Patents |
Schedule 1.110 | – | MWTX-001 |
Schedule 1.111 | – | MWTX-002 |
Schedule 1.112 | – | MWTX-003 |
Schedule 1.130 | – | Qualified Contract Manufacturers |
Schedule 2.2(b) | – | Initial Development Plan |
Schedule 4.4(a) | – | Product Specification |
Schedule 4.5(b) | – | Manufacturing Technology Transfer |
Schedule 7.2(a) | – | Core Licensed Patents |
Schedule 8.4 | – | Press Release |
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EXCLUSIVE LICENSE AGREEMENT
This Exclusive License Agreement (this “Agreement”) is made and entered into as of January 19, 2023 (the “Execution Date”) by and between Disc Medicine, Inc., a Delaware corporation having its registered address at 321 Arsenal Street, Suite 101, Watertown, MA 02472 (“Disc”), and Mabwell Therapeutics, Inc., a California corporation having its registered address at 505 Coast Boulevard South, Suite 301, La Jolla, CA 92037 (“Mabwell”). Disc and Mabwell are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
Recitals
WHEREAS, Mabwell Controls (as defined below) certain intellectual property rights with respect to Licensed Antibodies (as defined herein) and Licensed Products (as defined herein); and
WHEREAS, Mabwell wishes to grant to Disc, and Disc wishes to take, an exclusive license under such intellectual property rights to Exploit (as defined below) Licensed Antibodies and Licensed Products in the Licensed Territory (as defined below) in accordance with the terms and conditions set forth below.
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
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All discounts, allowances, credits, rebates, and other deductions set forth above shall be fairly and equitably allocated to such Licensed Product and other product(s) of Disc, its Affiliates or its Sublicensee(s) such that such Licensed Product does not bear a disproportionate portion of such deductions.
For purposes of determining Net Sales, a “sale” shall not include transfers or dispositions of a Licensed Product for pre-clinical or clinical purposes, compassionate use, humanitarian and charitable donations, indigent programs, or as samples, in each case, without charge. Disc’s transfer of any Licensed Product to a Sublicensee or a third party distributor shall not result in any Net Sales, unless such Licensed Product is consumed or sold to a Third Party by such Sublicensee or a third party distributor in the course of its commercial activities.
In the case of pharmacy incentive programs, hospital performance incentive programs, chargebacks, disease management programs, similar programs or discounts on portfolio product offerings, all rebates, discounts, and other forms of reimbursements shall be allocated among Licensed Products on the basis on which such rebates, discounts and other forms of reimbursements were actually granted or, if such basis cannot be determined, in accordance with Disc’s or its or their Sublicensees’ existing allocation method; provided that any such allocation to a Licensed Product (i) shall be done in accordance with Applicable Law, including any price reporting laws, rules, and regulations and (ii) subject to clause (i), shall be no greater than a pro rata allocation, such that the portion of each of foregoing rebates, discounts, and other forms of reimbursements shall not be included as deductions from Gross Sales hereunder in any amount greater than the proportion of the number of units of such Licensed Product sold by Disc or its Sublicensees to Third Parties hereunder compared to the number of units of all the products sold by Disc or its Sublicensees to Third Parties to which such foregoing rebate, discount, or other form of reimbursement, as applicable, are granted.
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In the event that a Licensed Product is sold in any country in the form of a Combination Product, Net Sales of such Combination Product shall be adjusted by multiplying actual Net Sales of such Combination Product in such country calculated pursuant to the foregoing definition of “Net Sales” by the fraction A/(A+B), where A is the average invoice price in such country of any Licensed Product that contains the same Licensed Antibody(ies) as such Combination Product as its sole active ingredient(s), if sold separately in such country, and B is the average invoice price in such country of each product that contains active ingredient(s) other than Licensed Antibody(ies) contained in such Combination Product as its sole active ingredient(s), if sold separately in such country. If either a Licensed Product that contains Licensed Antibody(ies) as its sole active ingredient or a product that contains any active ingredient(s) other than Licensed Antibody(ies) in the Combination Product as its sole active ingredient(s) is not sold separately in a particular country, prior to the date of the first commercial sale of such Combination Product, through the JSC or otherwise, the Parties shall negotiate in good faith and reach mutual agreement on a reasonable adjustment to Net Sales in such country that takes into account the medical contribution to the Combination Product of, and all other factors reasonably relevant to the relative value of, Licensed Antibody(ies), on the one hand, and all of the other active ingredient(s), collectively, on the other hand.
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For the avoidance of doubt, the Alliance Managers will be entitled to attend all JSC meetings.
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Development and Regulatory Milestone Event | Development and Regulatory Milestone Payment |
[***] | |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | |
[***] | [***] |
[***] | [***] |
[***] | [***] |
Total Development and Regulatory Milestone Payments: $127.5 million.
If a Development and Regulatory Milestone Event with respect to the First Indication, Second Indication or Third Indication is skipped and not been paid but a subsequent Development and Regulatory Milestone Event is achieved with respect to such Indication, then all prior Development and Regulatory Milestone Event for Licensed Product for such Indication shall be deemed achieved and shall become due and payable at the time of achievement of the subsequent Development and Regulatory Milestone Event.
As used herein, “First Indication”, “Second Indication” and “Third Indication” refer to the order of Indications for which the milestones are achieved, and do not need to be the same for each milestone. For example, “Second Indication” can be different for “Initiation of a Phase III Clinical Trial in the Second Indication in Licensed Territory” and “Obtaining Regulatory Approval in the United States for the Second Indication”.
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Commercial Milestone Event | Commercial Milestone Payment |
Upon first achieving Net Sales of Licensed Products totaling [***] in a Calendar Year. | [***] |
Upon first achieving Net Sales of Licensed Products totaling [***] in a Calendar Year. | [***] |
Upon first achieving Net Sales of Licensed Products totaling [***] in a Calendar Year. | [***] |
Upon first achieving Net Sales of Licensed Products totaling [***] in a Calendar Year. | [***] |
Upon first achieving Net Sales of Licensed Products totaling [***] in a Calendar Year. | [***] |
Upon first achieving Net Sales of Licensed Products totaling [***] in a Calendar Year. | [***] |
Total Commercial Milestone Payments: $275 million.
Portion of Net Sales in a Calendar Year | Royalty Rate on such Portion of Net Sales in such Calendar Year |
Portion of Net Sales greater than [***] and less than [***] in a Calendar Year. | [***] |
Portion of Net Sales between greater than or equal to [***] and less than [***] in a Calendar Year. | [***] |
Portion of Net Sales greater than or equal to [***] and less than [***] in a Calendar Year. | [***] |
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Portion of Net Sales greater than or equal to [***] and less than [***] in a Calendar Year. | [***] |
Portion of Net Sales greater than or equal to [***] and less than [***] in a Calendar Year. | [***] |
Portion of Net Sales greater than or equal to [***] in a Calendar Year. | [***] |
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Sublicense Revenue Tier | Percentage Due |
Sublicense Revenue under a sublicense granted [***]. | [***] |
Sublicense Revenue under a sublicense granted [***]. | [***] |
Sublicense Revenue under a sublicense granted [***]. | [***] |
Sublicense Revenue under a sublicense granted [***]. | [***] |
Sublicense Revenue under a sublicense granted [***]. | [***] |
Sublicense Revenue under a sublicense granted [***]. | [***] |
For the purpose of calculating any sums due under, or otherwise reimbursable pursuant to, this Agreement (including the calculation of Net Sales expressed in currencies other than Dollars), Disc shall convert any amount expressed in a foreign currency into Dollar equivalents upon written notice to Mabwell using its or its Sublicensee’s, as applicable, standard conversion methodology consistent with GAAP.
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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. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination and its principles are in the public domain or in the possession of the receiving Party.
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If to Disc, to:
Disc Medicine, Inc.
321 Arsenal Street, Suite 101
Watertown, MA 02472
Attn: Joanne Bryce
Facsimile: [***]
with a copy (which shall not constitute notice) to:
Goodwin Procter LLP
601 S Figueroa Street, 41st Floor
Los Angeles, CA 90017
Attention: Beni Surpin
Facsimile: [***]
If to Mabwell, to:
505 Coast Boulevard South, Suite 301
La Jolla, CA 92037
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Attn: Xin Du, Chief Executive Officer
Facsimile: [***]
with a copy (which shall not constitute notice) to:
Cooley LLP
10265 Science Center Drive
San Diego, CA 92121
Attention: Charity R. Williams
Facsimile: [***]
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[signature page follows]
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IN WITNESS WHEREOF, this Agreement is executed by the authorized representatives of the Parties as of the Execution Date.
DISC MEDICINE, INC. |
| MABWELL THERAPEUTICS, INC. | ||
By: | /s/ John Quisel |
| By: | /s/ Xin Du |
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Name: | John Quisel |
| Name: | Xin Du |
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Title: | Chief Executive Officer |
| Title: | Chief Executive Officer |
[SIGNATURE PAGE TO EXCLUSIVE LICENSE AGREEMENT]