Exhibit 10.1
CONFIDENTIAL
FOR DISCUSSION PURPOSES ONLY
EXECUTION VERSION
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
Research Collaboration and License Agreement
This Research Collaboration and License Agreement (“Agreement”) is made and entered into effective as of May 8, 2023 (the “Effective Date”), by and between TScan Therapeutics, Inc., a Delaware corporation, having its offices at 830 Winter Street, Waltham, Massachusetts 02451 (“TScan”), and Amgen Inc., a Delaware corporation, having its offices at One Amgen Center Drive, Thousand Oaks, California 91320 (“Amgen”). Unless otherwise expressly stated otherwise in the Agreement, Amgen may perform any of its responsibilities and exercise any of its rights hereunder through any of its Affiliates. TScan and Amgen each may be referred to herein individually as a “Party”, or collectively as the “Parties.”
Recitals
Whereas, TScan is a biotechnology company and has licensed and further developed a technology to perform a genome-wide screening platform to identify antigens recognized by T-cells, as further described on Exhibit 1 (the “TScan Platform”), and owns or controls certain intellectually property rights in respect of such technology;
Whereas, Amgen is a biopharmaceutical company that is engaged in, among other things, the research, development, manufacture and commercialization of pharmaceutical products;
Whereas, TScan and Amgen desire to enter into a research and development collaboration (the “Collaboration”) to use the TScan Platform to collect and process tissue samples from patients with Crohn’s disease and identify dominant immunogenic targets of regulatory versus effector CD4+ T-cells; and
Whereas, TScan desires to grant Amgen exclusive, worldwide, sublicensable licenses to develop and commercialize the product candidates created and developed during the collaboration, and Amgen desires to obtain such licenses.
Now, Therefore, in consideration of the premises and the mutual covenants and agreements herein contained, the Parties agree as follows:
When used in this Agreement, capitalized terms will have the meanings as defined below and throughout the Agreement.
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Sales among a Party and its Affiliates or Sublicensees for resale shall be excluded from the computation of Net Sales; provided, however, that the subsequent resale to a Third Party shall be included in Net Sales hereunder. Any disposal of Products for, or use of Products in, clinical or pre-clinical trials, given as free samples, or distributed at no charge to or for patients unable to purchase Product shall not be included in Net Sales. If the Product is sold for consideration other than cash, the Net Sales from such sale or transfer shall be deemed to be sold exclusively for money at the average sales price during the applicable reporting period generally achieved for such Product in the country in which such sale or other disposal occurred when such Product is sold alone and not with other products. In the event no sales price is available for the Product alone in such country during the applicable reporting period, then such Product shall be deemed to be sold exclusively for money at the arithmetic mean sales price during the applicable reporting period generally achieved for such Product in all countries in which such sale or other disposal occurred when such Product is sold alone and not with other products; provided, however, that if such Product is not sold alone in any country, then Amgen shall calculate in good faith a hypothetical market price for the Product, allocating the same proportion of costs, overhead and profit as are then allocated to all similar substances then being made and marketed by Amgen and having an ascertainable market price.
In the event the Product is sold with one or more other pharmaceutically active ingredients for a single contracted price (together, a “Multiple Product Offering”) in a given country, Net Sales in such country for such Multiple Product Offering shall be calculated by [***] where A is the ASP of the Product, if sold separately, and B is the sum of the ASPs for each of the other products in the Multiple Product Offering, if sold separately. If, on a country-by-country basis, the other products in the Multiple Product Offering are not sold separately in said country, Net Sales for the purpose of determining royalties of the Multiple Product Offering in such country shall be calculated by [***], where A is the ASP of the Product, if sold separately, and D is the ASP of the Multiple Product Offering. If neither the Product nor the other products are sold separately in a given country, the Parties shall determine Net Sales for such Multiple Product Offering in such country by mutual agreement based on [***].
Net Sales shall be calculated on an accrual basis, in a manner consistent with Amgen’s accounting policies for external reporting purposes, as consistently applied, in accordance with GAAP.
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Definition | Section |
Accounting Firm | 8.8 |
Agreement | Preamble |
Allele Substitution Period | 3.3.4 |
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Definition | Section |
Alliance Manager | 2.5 |
Amgen | Preamble |
Amgen Prosecuted Patents | 10.2.2 |
Anti-Corruption Laws | 13.5.4 |
Bankruptcy Laws | 11.11 |
CDA | 9.1 |
Collaboration | Recitals |
Commercial Milestone Term | 8.4.2 |
[***] | [***] |
Confidential Information | 9.1 |
Development Milestone Term | 8.4.1 |
Disclosing Party | 9.1 |
Disclosure Laws | 9.5 |
Disclosure Subject | 9.5 |
Dispute | 15.3.2 |
Effective Date | Preamble |
Enforcing Party | 10.6.4 |
Expansion | 3.8.3 |
Gatekeeper | 3.11.1 |
HLA Expansion | 3.3.1 |
HLA Expansion Fee | 3.3.3 |
In-Licensed IP Agreements | 10.1.110.1 |
Indemnification Claim Notice | 12.3.1 |
Indemnifying Party | 12.3.1 |
Indemnitee | 12.3.1 |
Indirect Taxes | 8.10.2 |
Invalidity Claim | 10.5.1 |
Joint Steering Committee or “JSC” | 2.1 |
Losses | 12.1 |
Materials | 5.1 |
Other Acquiror Program | 6.4.4 |
Party(ies) | Preamble |
Program | 3.1 |
Receiving Party | 9.1 |
Records | 8.8 |
Removed Allele | 3.3.4 |
Representatives | 13.5.4 |
ROFO | 3.10.1 |
ROFO Notice | 3.10.1 |
ROFO Notice Date | 3.10.1 |
ROFO Notice Period | 3.10.1 |
Royalty Patents | 8.5.2 |
Royalty Term | 8.5.2 |
Substitute Allele | 3.3.4 |
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Definition | Section |
TScan | Preamble |
Term | 11.1 |
Term Sheet | 3.10.2 |
Third Party Claims | 12.1 |
TScan Platform | Recitals |
TScan Prosecuted Patents | 10.2.1 |
UC Collaboration Agreement | 3.10.1 |
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provided that, the resolution selected by the applicable Party under clause (a) or (b) above shall not conflict with the applicable terms and conditions of this Agreement; and provided, further, that no Party may resolve any matter in a manner that (i) would be reasonably likely to result in the other Party or its Affiliates breaching this Agreement, violating Applicable Law, infringing the Intellectual Property Rights of any Third Party, or breaching any agreement pursuant to which such other Party or its Affiliates is a party
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or (ii) would result in a unilateral decision that is otherwise stated herein to require the mutual agreement or mutual consent of the Parties.
For the avoidance of doubt, any amendment or modification of this Agreement shall be subject to the requirements set forth in Section 15.5.
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Development Milestone Event | Milestone payment (in US Dollars) |
[***] | [***] |
[***] | [***] |
[***] | [***] |
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[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
Commercial Milestone Event | Milestone Payment (in US Dollars) |
Annual worldwide aggregate Net Sales of all Products in excess of [***] | [***] |
Annual worldwide aggregate Net Sales of all Products in excess of [***] | [***] |
Annual worldwide aggregate Net Sales of all Products in excess of [***] | [***] |
Annual worldwide aggregate Net Sales of all Products in excess of [***] | [***] |
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Net Sales Tier | Royalty |
With respect to any portion of annual Net Sales of Products in the Territory less than [***] | [***] of Net Sales of such Products |
With respect to any portion of annual Net Sales of Products in the Territory equal to or greater than [***] and less than [***] | [***] of Net Sales of such Products |
With respect to any portion of annual Net Sales of Products in the Territory equal to or greater than [***] and less than [***] | [***] of Net Sales of such Products |
With respect to any portion of annual Net Sales of Products in the Territory equal to or greater than [***] | [***] of Net Sales of such Products |
Amgen shall pay royalties and deliver royalty reports in accordance with Section 8.7.2 on a country‑by‑country basis. By way of example and without limitation of this Section 8.5.1, if Net Sales of Products are equal to [***], then the royalties payable for such Products, subject to adjustment as set forth in this Section 8.5, would be: [***].
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Amgen Inc.
Accounts Payable
PO Box 667
Newbury Park, CA 91319-0667
Attention: Partnership Accounting
Reference: Amgen Contract No. [***]
Email: [***]
Within [***] of Amgen’s receipt of this fully signed Agreement, Amgen will provide a purchase order number to TScan. TScan agrees to submit invoices to Amgen (on a timely basis) for all payments due hereunder. Invoices must reference Amgen’s contract number and the purchase order number. Invoices not referencing the contract number and the purchase order number will be subject to delay or rejection.
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If to TScan, to:
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TScan Therapeutics, Inc.
830 Winter Street
Waltham, Massachusetts 02451
Attn: Chief Legal Officer
with a copy (which will not constitute notice) to:
TScan Therapeutics, Inc.
880 Winter Street
Waltham, Massachusetts 02451
Attn: Chief Business Officer
If to Amgen, to:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320
Attn.: Corporate Secretary
with a copy (which will not constitute notice) to:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320
Attention: Alliance Management
Facsimile: [***]
Email: [***]
Except where notice is required to be given under this Agreement, it is understood and agreed that this Section is not intended to govern the day-to-day business communications necessary between the Parties in performing their duties, in due course, under the terms of this Agreement.
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Amgen Proprietary - Confidential
.
In Witness Whereof, the Parties have executed this Agreement by their respective authorized representatives as of the date first written above.
TScan Therapeutics, Inc.
By: /s/ Gavin MacBeath
Name: Gavin MacBeath
Title: Acting Chief Executive Officer, Chief Scientific Officer and Chief Operating Officer
Amgen Inc.
By: /s/ Robert A. Bradway
Name: Robert A. Bradway
Title: Chairman of the Board, President
and Chief Executive Officer
Amgen Proprietary – Confidential
Amgen Contract No. [***]
Amgen Proprietary - Confidential
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EXHIBIT 1
TScan Platform
[***]
Amgen Proprietary – Confidential
Amgen Contract No. [***]
Amgen Proprietary - Confidential
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EXHIBIT 2
Initial Research Work Plan
[***]
Scope of Collaboration
[***]
Objective:
[***]
Detailed Workplan:
[***]
TScan Deliverables:
[***]
Amgen Proprietary – Confidential
Amgen Contract No. [***]
Amgen Proprietary - Confidential
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EXHIBIT 3
TScan License Agreements
[***]
Amgen Proprietary – Confidential
Amgen Contract No. [***]
Amgen Proprietary - Confidential
Exhibit 4
INFORMATION SECURITY REQUIREMENTS SCHEDULE
[***]
TSCAN THERAPEUTICS, INC. |
| AMGEN INC. |
|
|
|
/s/ Gavin MacBeath |
| /s/ Robert A. Bradway |
Print Name: Gavin MacBeath |
| Print Name: Robert A. Bradway |
Title: Acting Chief Executive Officer, Chief Scientific Officer and Chief Operating Officer |
| Title: Chairman of the Board, President and Chief Executive Officer
|
Date: May 5, 2023 |
| Date: May 5, 2023 |
Amgen Proprietary – Confidential
Amgen Contract No. [***]