Exhibit 10.1
EXECUTION VERSION
Portions of this Exhibit have been redacted because they are both (i) not material and (ii) the registrant customarily and actually treats such information as private or confidential. Information that was omitted has been noted in this document with a placeholder identified by the mark “[***]”.
Portions of this Exhibit have been redacted because they are both (i) not material and (ii) the registrant customarily and actually treats such information as private or confidential. Information that was omitted has been noted in this document with a placeholder identified by the mark “[***]”.
LICENSE AGREEMENT
between
KYMAB LIMITED
and
RALLYBIO IPE, LLC
Dated as of May 5, 2022
Exhibit 10.1
EXECUTION VERSION
TABLE OF CONTENTS
ARTICLE 1 DEFINITIONS 1
ARTICLE 2 GRANT OF RIGHTS 11
2.1 Grants 11
2.2 Retention of Rights 12
2.3 Sublicenses 12
2.4 No Implied Rights 12
2.5 Disclosure of Licensed Know-How 12
2.6 Transferred Materials 13
2.7 Technical Assistance 13
ARTICLE 3 DEVELOPMENT AND REGULATORY 13
3.1 Development 13
3.2 Development Diligence 14
3.3 Development Reports 14
3.4 Subcontracting 14
3.5 Compliance 14
3.6 Regulatory Matters 14
ARTICLE 4 COMMERCIALIZATION 14
4.1 In General 15
4.2 Commercialization Reports 15
4.3 Commercialization Diligence 15
4.4 Compliance with Applicable Law 15
4.5 Sales and Distribution 15
4.6 Subcontracting 15
ARTICLE 5 MANUFACTURE AND SUPPLY 16
5.1 In General 16
5.2 Subcontracting 16
5.3 Compliance 16
ARTICLE 6 PAYMENTS 16
6.1 Upfront Payment 16
6.2 Milestones 16
6.3 Royalties 18
6.4 Payment Dates and Reports 19
6.5 Sublicense Income; Transfer Income 19
6.6 Priority Review Voucher 19
6.7 Mode of Payment; Currency Conversion 19
6.8 Taxes 20
6.9 Interest on Late Payments 20
6.10 Financial Records 20
6.11 Audit 20
6.12 Audit Dispute 21
6.13 Confidentiality 21
ARTICLE 7 INTELLECTUAL PROPERTY 21
7.1 Ownership of Arising Know-How 21
7.2 Prosecution and Maintenance of Patents 21
7.3 Enforcement of Patents 23
7.4 Infringement Claims by Third Parties 24
7.5 Invalidity or Unenforceability Defenses or Actions 24
7.6 Third Party Licenses 25
7.7 Product Trademarks 25
ARTICLE 8 PHARMACOVIGILANCE AND SAFETY 26
8.1 Global Safety Database. 26
8.2 Pharmacovigilance Agreement 26
ARTICLE 9 Confidentiality AND Non-Disclosure 26
9.1 Confidentiality Obligations 26
9.2 Permitted Disclosures 27
9.3 Use of Name 28
9.4 Press Releases 28
9.5 Publications 29
9.6 Destruction of Confidential Information 29
ARTICLE 10 REPRESENTATIONS AND WARRANTIES 29
10.1 Mutual Representations and Warranties 29
10.2 Representations, Warranties and Covenants of Sanofi Kymab 30
10.3 Representations, Warranties and Covenants of Licensee 31
10.4 Disclaimer of Warranty 31
10.5 Additional Wavier 31
ARTICLE 11 Indemnity 32
11.1 Indemnification of Sanofi Kymab 32
-ii-
11.2 Indemnification of Licensee 32
11.3 Notice of Claim 33
11.4 Control of Defense 33
11.5 Limitation on Damages and Liability 35
11.6 Insurance 35
ARTICLE 12 Term and Termination 35
12.1 Term 35
12.2 Termination for Convenience 35
12.3 Termination of this Agreement for Material Breach 35
12.4 Termination by Sanofi Kymab for Patent Challenge 36
12.5 Termination Upon Insolvency 36
12.6 Rights in Bankruptcy 36
12.7 Consequences of Termination 37
12.8 Accrued Rights; Surviving Obligations 37
ARTICLE 13 Miscellaneous 38
13.1 Force Majeure 38
13.2 Alliance Managers 38
13.3 Export Control 38
13.4 Assignment; Change of Control 38
13.5 Severability 39
13.6 Dispute Resolution 39
13.7 Governing Law, Jurisdiction, and Venue 39
13.8 Notices 40
13.9 Entire Agreement; Amendments 41
13.10 English Language 41
13.11 Equitable Relief 41
13.12 Waiver and Non-Exclusion of Remedies 41
13.13 No Benefit to Third Parties 41
13.14 Further Assurance 42
13.15 Relationship of the Parties 42
13.16 References 42
13.17 Construction 42
13.18 Performance through Affiliates 42
13.19 Counterparts 42
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Schedules
Schedule 1.8 | Back-up Sequences |
Schedule 1.57 | Licensed Anemia Patents |
Schedule 1.58 | KY1066 Sequence |
Schedule 1.59 | Licensed Know-How |
Schedule 1.60 | Licensed Platform Patents |
Schedule 1.62 | Licensed Product Patents |
Schedule 1.75 | Baseball Arbitration for Determination of Net Sales of Combination Products |
Schedule 2.6 | Transferred Materials |
Schedule 3.1.2 | Development Plan |
Schedule 9.4 | Initial Press Release |
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LICENSE AGREEMENT
This License Agreement (this “Agreement”) is made and entered into as of May 5, 2022 (the “Effective Date”) by and between Kymab Limited, a corporation incorporated in the United Kingdom, having offices located at Bennet Building (B930), Babraham Research Campus, Cambridge, UK, CB22 3AT (“Sanofi Kymab” or “Licensor”) and Rallybio IPE LLC, a Delaware limited liability company, having offices located at 234 Church Street, Suite 1020, New Haven, CT 06510 (“Rallybio” or “Licensee”). Sanofi Kymab and Licensee are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, Sanofi Kymab controls certain property rights with respect to the Licensed Compound (as defined herein) and Licensed Products (as defined herein) in the Territory (as defined herein); and
WHEREAS, Sanofi Kymab wishes to grant to Licensee, and Licensee wishes to be granted, a license under such property rights to Exploit (as defined herein) Licensed Products in the Territory, in each case, in accordance with the terms and conditions set forth below.
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, 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:
DEFINITIONS
Unless otherwise specifically provided herein, the following terms shall have the following meanings:
1
2
3
4
5
6
[***].
[***].
Licensee’s, its Affiliates’ or its or their Sublicensees’ transfer of any Licensed Product to an Affiliate or Sublicensee shall not result in any Net Sales, unless such Licensed Product is consumed by such Affiliate or Sublicensee in the course of its commercial activities.
7
8
9
10
GRANT OF RIGHTS
11
12
DEVELOPMENT AND REGULATORY
13
COMMERCIALIZATION
14
15
MANUFACTURE AND SUPPLY
PAYMENTS
16
| Development and Regulatory Milestone Events | Development and Regulatory Milestone Payments |
1 | [***] |
$[***] |
2 | [***] | $[***] |
3 | [***] | $[***] |
4 | [***] | $[***] |
5 | [***] | $[***] |
6 | [***] | $[***] |
In the event that Licensee, its Affiliate or Sublicensee, as applicable, combines a Phase 1 Clinical Study and a Phase 2 Clinical Study into a Phase 1/2 Clinical Study, then the Development Milestone Payments payable for the Start of a Phase 2 Clinical Study shall be payable at the Start of the Phase 2 portion of such Phase 1/2 Clinical Study.
In the event that Licensee, its Affiliate or Sublicensee, as applicable, combines a Phase 2 Clinical Study and a Phase 3 Clinical Study into a Phase 2/3 Clinical Study, and the Development Milestone Payment payable for the Start of a Phase 2 Clinical Study has not been paid, then the Development Milestone Payments payable for each of the Start of a Phase 2 Clinical Study and a Phase 3 Clinical Study shall both be payable at the Start of such Phase 2/3 Clinical Study.
Nothing in this Section 6.2.1 (Development and Regulatory Milestones) shall be construed as to limit or otherwise cap any payments owed to Sanofi Kymab under any other provision of this Agreement, including without limitation Section 6.5 (Sublicense Income; Transfer Income).
With respect to Development and Regulatory Milestone Events other than those for Market Approval in a country or region, if a latter event is achieved before an earlier event, then the Development and Regulatory Milestone Payment for the earlier Development and Regulatory Milestone Event shall become due and payable upon the achievement of the next Development and Regulatory Milestone.
17
| Sales Milestone Events | Sales Milestone Payments |
A | Aggregate Net Sales of all Licensed Products in the Territory in a Calendar Year exceed [***] | [***] |
B | Aggregate Net Sales of all Licensed Products in the Territory in a Calendar Year exceed [***] | [***] |
C | Aggregate Net Sales of all Licensed Products in the Territory in a Calendar Year exceed [***] | [***] |
That portion of Net Sales of all Licensed Products in the Territory in a Calendar Year that is: | Royalty rate
|
Less than $[***] | [***] |
Equal to or greater than $[***] but less than $[***] | [***] |
Equal to or greater than $[***] | [***] |
18
19
20
INTELLECTUAL PROPERTY
21
22
23
24
25
PHARMACOVIGILANCE AND SAFETY
CONFIDENTIALITY AND Non-Disclosure
26
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.
27
28
REPRESENTATIONS AND WARRANTIES
29
30
31
Indemnity
32
33
34
Term and Termination
35
36
37
Miscellaneous
38
39
If to Licensee, to:
c/o Rallybio IPE, LLC
234 Church Street, Suite 1020
New Haven, CT 06510
Attention: General Counsel
Email: legal@rallybio.com (which does not constitute notice)
If to Sanofi Kymab, to:
c/o Sanofi
82, avenue Raspail
94250 Gentilly, France
Attention: Head of Out-Licensing Management
40
Global Alliance Management
Telephone: [***]
Email: alliance.management@sanofi.com (which does not constitute notice)
41
42
[SIGNATURE PAGE FOLLOWS]
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THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the date first written above.
KYMAB LIMITED | Rallybio IPE, LLC |
By: /s/ Gordon Tillet Name: Gordon Tillet |
By: /s/ Stephen Uden Name: Stephen Uden
|
44