Exhibit 10.1
Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
COLLABORATION AND LICENSE AGREEMENT
BY AND BETWEEN
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
Binger Strasse 173, 55216 Ingelheim am Rhein
AND
Surrozen OPERATING, INC.
171 Oyster Point Blvd., Suite 400, South San Francisco, CA 94080
BI Contract No: 43105378
277004734 v2
COLLABORATION AND LICENSE AGREEMENT
This COLLABORATION AND LICENSE AGREEMENT (the “Agreement”) is effective as of 30 September 2022 (the “Effective Date”) and is entered into by and between BOEHRINGER INGELHEIM INTERNATIONAL GMBH, a corporation organized and existing under the laws of Germany, having a business address at Binger Str. 173, 55216 Ingelheim am Rhein, Germany (“BI”), and Surrozen Operating, Inc., a corporation organized and existing under the laws of Delaware, having its registered office at 171 Oyster Point Blvd. #400, South San Francisco, CA 94080 (“SU”). BI and SU are referred to individually as a “Party” and collectively as the “Parties”.
RECITALS
WHEREAS, BI is a research-based pharmaceutical company that is a member of the Boehringer Ingelheim group of companies, which group possesses expertise and resources relating to the research, development, manufacturing and marketing of pharmaceutical products;
WHEREAS, SU is a research-based biotechnology company discovering and developing drug candidates to selectively modulate the Wnt pathway with potential application across multiple disease areas, including inflammatory bowel disease, hepatitis, eye diseases, hearing loss, lung and airway diseases, and certain neurological disorders;
WHEREAS, the Parties envisage to establish a collaboration which provides BI access to a research program in Diabetic Macular Ischemia, other ophthalmology indications, and Intellectual Property (as defined below) related to Fzd4 SWAPs (Surrozen Wnt Signal Activating Protein) for tissue-specific modulation of the Wnt pathway;
WHEREAS, BI desires to obtain an exclusive license from SU to Develop and Commercialize Compounds and Products in the Field (as defined below) in the Territory (as defined below), and SU is willing to grant such a license to BI on the terms and conditions set forth herein;
WHEREAS, BI recognizes SU’s expertise in the field of SWAPs and the Parties wish to enter into a research collaboration to Develop Compounds and / or Products as further described in the Research Program.
WHEREAS, this Agreement governs the terms and conditions of the exclusive license to the Licensed Technology, the duration and scope of the rights granted, the ownership of Intellectual Property related to and/or generated under this Agreement, the collaborative Development activities with respect to Compounds such as, inter alia, the responsibilities and activities to be performed by each Party, and the consideration payments owed by BI to SU.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and for good and sufficient consideration, the sufficiency of which is acknowledged by the Parties, the Parties hereby agree as follows:
Unless specifically set forth to the contrary under this Agreement, the following terms, whether used in singular or plural form, shall have the respective meanings set forth below.
Information that is otherwise confidential and consists of a combination of information shall not be deemed to be in the public domain if individual elements of such information are in the public domain, unless the specific combination of those elements is also in the public domain. The terms of this Agreement shall be deemed the Confidential Information of both Parties. Confidential Information of a Party shall include any information disclosed by a Third Party to such Party under obligations of confidentiality pursuant to the terms of any agreements between such Third Party and such Party, provided the information otherwise meets the criteria of Confidential Information (as described above).
BI, its Affiliates and Sublicensees shall not [*] on the Product in order to [*], such that the Product would [*]. All defined deductions in this section shall be consistent with BI’s audited financial statements.
For the sake of clarity and avoidance of doubt, sales by BI, its Affiliates, or Sublicensees of a Product to Recognized Agent of such Product in a given country shall be considered a sale to a Third Party customer.
[*] shall not be included in Net Sales. [*] shall also not be part of Net Sales.
Upon any sale or other disposal of any Product that should be included in Net Sales for any consideration other than an exclusively monetary consideration on bona fide arm’s length terms, then for purposes of calculating the Net Sales under this Agreement, such Product shall be deemed to be [*] during the applicable reporting period [*] for such Product in the country in which such sale or other disposal occurred when such Product is [*]. In the event no [*] is available for the Product [*] in such country during the applicable reporting period, then such Product shall be deemed to be [*] at the [*] during the applicable reporting period [*] for such Product in all countries in which such sale or other disposal occurred when such Product is [*] (provided, however, that if such Product is not [*] in any country, then BI shall calculate in good faith [*] for the Product, [*] as are then [*] to [*] then being [*] and having [*]; provided, however, that if [*], the Parties shall [*].
In the event a Product is sold as a Combination Product or Co-Packaged Product, Net Sales of the Combination Product or Co-Packaged Product will be calculated as follows:
The [*] for such other product(s) contained in the Combination Product or Co-Packaged Product shall be calculated for each Calendar Year by [*] of such other product(s), as published by IQVIA or another mutually agreed independent source.
In the initial Calendar Year during which a Combination Product or Co-Packaged Product is sold, a forecasted [*] shall be used for the Product, other product(s), or Combination Product and/or Co-Packaged Product. Any over- or underpayment due to a difference between forecasted and actual [*] shall be paid or credited in the second royalty payment of the following Calendar Year. In the following Calendar Year the [*] of the previous Calendar Year shall apply from the second royalty payment on.
Term | Section |
Acquirer | 1.12 |
Additional Cure Period | 17.2.1 |
Alliance Manager | 7.6 |
Animal Welfare Questionnaire | 15.1.1 |
Auditor | 11.10.5 |
Bankruptcy Code | 9.9 |
BI Auditors | 11.16 |
BI Indemnitees | 16.1 |
BI Foreground IP | 9.1.3 |
Competing Program | 4.5 |
Damages | 16.1 |
Data Package | 6.1 |
Default Cure Period | 17.2.1 |
Default Notice | 17.2.1 |
Defaulting Party | 17.2.1 |
Development Milestone Event | 11.5 |
Development Milestone Payment | 11.5 |
Development Report | 3.3 |
Disclosing Party | 1.20 |
Dispute | 18.1 |
ICC | 18.2 |
Indemnified Party | 16.3 |
Indemnifying Party | 16.3 |
Indication Non-Compete Period | 4.3 |
Infringed Non-Product-Specific Patent | 9.5.4 |
Infringed Product-Specific Patent | 9.5.1 |
IP Action | 9.8.1 |
Items | 13.1 |
Joint Foreground IP | 9.1.4 |
Joint Steering Committee or JSC | 7.1 |
Material Provider | 2.3 |
Material Receiver | 2.3 |
New Mandatory Hybrid License | 9.11.2 |
New Mandatory Hybrid Technology | 9.11.2 |
New Optional Hybrid Technology | 9.11.3 |
New Optional Hybrid License | 9.11.3 |
New Specific Technology | 9.11.1 |
New Third Party Specific License | 9.11.1 |
New Third Party License | 9.11.3 |
Non-Defaulting Party | 17.2.1 |
Non-Product-Specific Patenting Activities | 9.2.4 |
Patent Term Extension | 9.4 |
Product-Specific Patenting Activities | 9.2.2 |
Program Director | 7.5 |
Provided Materials | 2.3 |
Receiving Party | 1.20 |
Regulatory Milestone Event | 11.6 |
Regulatory Milestone Payment | 11.611.6 |
Related Molecules | 1.71 |
Replacement Product | 11.9 |
Request | 18.2 |
Research Milestone Event | 11.4 |
Research Milestone Payment | 11.4 |
Research Program | 2.1 |
Royalty | 11.10.1 |
Royalty Term | 11.10.2b |
Rules | 18.2 |
Sales Milestone Event | 11.8 |
Sales Milestone Payment | 11.8 |
Selection Period | 17.1 |
SU Deliverables | 2.2 |
SU Foreground IP | 9.1.2 |
SU Indemnitees | 16.2 |
SU/Sublicensee Agreement | 5.4 |
Third Party Claim | 16.3 |
Trade Compliance Laws | 13.1 |
Any sublicense granted by BI to a Sublicensee that contains terms and conditions materially consistent with those in this Agreement shall [*] pursuant to Section [*], provided that (a) such Sublicensee [*] the applicable sublicense or any terms of this Agreement [*] and (b) within [*] of such [*] the Sublicensee requests in writing to SU to [*] that [*] terms and conditions applicable to the Licensed Technology [*] agreement between BI and Sublicensee. SU herewith agrees to [*] provided that (i) SU does not have any obligations [*] pursuant to this Agreement and (ii) SU’s rights thereunder (including to [*]) are [*] pursuant to this Agreement with respect to [*] to such Sublicensee.
The JSC shall not have the power to amend the terms of, or waive compliance with, this Agreement. Unless otherwise set forth in this Agreement, any amendments to the Research Plan must be [*] and must not lead to [*] by either Party.
The Agreement shall otherwise continue in accordance with its terms, in particular, BI shall retain all of its licenses and other rights hereunder, subject to all of its milestone and royalty payment obligations. However, if SU breaches its obligations according to subsection a. of this Article 8 and such breach constitutes a Default under Section 17.2.1, BI shall have the right to terminate this Agreement for cause in accordance with and under the conditions of Section 17.2.1.
The Party enforcing an or defending a Patent pursuant to this Section 9.5 (“Patent Enforcement”) shall keep the other Party reasonably informed of the progress of any such action, and such other Party shall have the right to participate with counsel of its own choice and at its own expense. In addition, the Parties shall assist one another and reasonably cooperate in any such action at the other Party’s reasonable request and expense (including joining as a party plaintiff to the extent necessary or so requested by the other Party). The proceeds (e.g., damages or other compensation) of any enforcement or defense action of BI under this Section 9.5 shall be for the benefit of [*]; provided, however, that any such proceeds actually received by [*] shall, after deduction of the costs and expenses actually borne by and not reimbursed to [*] with respect to such enforcement or defense action, on a Product-by-Product basis, be [*].
| Research Milestone Event | Research Milestone Payment |
1. | [*] | [*] US dollars |
2. | [*] | [*] US dollars |
| Development Milestone Event | Development Milestone Payment |
3. | [*] | [*] US dollars |
4. | [*] | [*] US dollars |
5. | [*] | [*] US dollars |
6. | [*] | [*] US dollars |
7. | [*] | [*] US dollars |
8. | [*] | [*] US dollars |
9. | [*] | [*] US dollars |
10. | [*] | [*] US dollars |
The Development Milestone Payments for [*] (Development Milestone Events [*]) shall be [*] if [*].
| Regulatory Milestone Event | Regulatory Milestone Payment |
11. | [*] | [*] US dollars |
12. | [*] | [*] US dollars |
13. | [*] | [*] US dollars |
14. | [*] | [*] US dollars |
15. | [*] | [*] US dollars |
16. | [*] | [*] US dollars |
17. | [*] | [*] US dollars |
18. | [*] | [*] US dollars |
19. | [*] | [*] US dollars |
20. | [*] | [*] US dollars |
21. | [*] | [*] US dollars |
22. | [*] | [*] US dollars |
23. | [*] | [*] US dollars |
24. | [*] | [*] US dollars |
25. | [*] | [*] US dollars |
26. | [*] | [*] US dollars |
27. | [*] | [*] US dollars |
28. | [*] | [*] US dollars |
For the avoidance of doubt, the first Product could be different for different countries or different events. The Regulatory Milestone Payments for [*] (Regulatory Milestone Events [*]) shall be [*] if [*].
BI shall pay to SU each of the following non‑refundable, non‑creditable milestone payments (each a “Sales Milestone Payment“) for the first achievement by a Product of the corresponding milestone event set forth in the table below (each a “Sales Milestone Event“):
| Sales Milestone Event (in USD) | Sales Milestone Payment |
29. | [*] | [*] US dollars |
30. | [*] | [*] US dollars |
31. | [*] | [*] US dollars |
32. | [*] | [*] US dollars |
Each Sales Milestone payment shall be paid together with the Royalty payments of the Calendar Quarter during which the Sales Milestone Event has been achieved.
Annual Net Sales in the Territory of a Product | Royalty on Net Sales |
On that portion below USD [*] | [*]% |
On that portion between USD [*] and USD [*] | [*]% |
On that portion between USD [*] and USD [*] | [*]% |
On that portion between USD [*] and USD [*] | [*]% |
On that portion higher than USD [*] | [*]% |
If to SU:
Surrozen Operating Inc.
Attn: Head of Business Development and Head of Legal
171 Oyster Point Blvd, Suite 400
South San Francisco, CA 94080
Emails: [*]
With a copy to:
Marya Postner
Cooley
3175 Hanover Street
Palo Alto, CA 94304-1130
Email: [*]
If to BI:
Boehringer Ingelheim International GmbH
Attn: Head of Transactions and Contract Management
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
E-mail: [*]
With a copy to:
Head of Corporate Legal
(Address as above)
Fax: [*]
[the remainder of this page is intentionally blank]
IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate originals by their duly authorized representatives as of the date and year first above written
Boehringer Ingelheim International GmbH
By: /s/ ppa. Detlev Mennerich
Name: Detlev Mennerich
Title: Authorized Signatory
By: /s/ ppa. Dorothee Schwall-Rudolph
Name: Dorothee Schwall-Rudolph
Title: Authorized Signatory
Surrozen OPERATING, INC.
By: /s/ Charles Williams
Name: Charles Williams
Title: Chief Financial Officer
Schedules:
Schedule 1.44: Requirements for Invoices
Schedule 1.51: Non-Exhaustive List of Licensed Technology
Schedule 1.77: Research Plan
Schedule 1.91: Side Letters
Schedule 2.3: Material Transfer Record Form
Schedule 3.3: Development Report
Schedule 5.5: Upstream License Terms and Required Information
Schedule 6.1: Technology Data Package Transfer
Schedule 6.4: Material Supply
Schedule 10.4: Press Release
Schedule 14.2: Partner Shipment Form
Schedule 15.1.1: Animal Welfare Questionnaire
Schedule 1.44
Requirements for Invoices
[*]
Schedule1.51
Non-Exhaustive List of Licensed Technology
[*]
{3 Pages Omitted}
Schedule 1.77
Research Plan
[*]
{15 Pages Omitted}
Schedule 1.91
[*]
{59 Pages Omitted}
SCHEDULE 2.3
Material Transfer Record Form
[*]
{4 Pages Omitted}
Schedule 3.3
Development Report
[*]
{6 Pages Omitted}
Schedule 5.5
Upstream License Provisions
[*]
{12 Pages Omitted}
Schedule 6.15F
Technology Data Package Transfer
[*]
© 2020 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved.
Schedule 6.4
Material Supply6F
[*]
Schedule 10.4
Press Release
[*]
{3 Pages Omitted}
Schedule 14.2
Partner Shipment Form
[*]
{3 Pages Omitted}
Schedule 15.1.1
Animal Welfare Questionnaire
[*]
{9 Pages Omitted}