Exhibit 10.1
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certain identified information CONTAINED IN THIS EXHIBIT, MARKED BY [***], HAS BEEN EXCLUDED FROM THIS EXHIBIT because it is both not material and is the type that the registrant treats as private or confidential.
STRATEGIC COLLABORATION AND LICENSE AGREEMENT
AMONG
ADAPTIMMUNE LIMITED,
on the one hand,
AND
GENENTECH, INC.
AND
F. Hoffmann-La Roche Ltd,
on the other hand
AS OF September 3, 2021
TABLE OF CONTENTS
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List of Schedules and Exhibits
Schedule 1.50 Excluded Targets
Schedule 1.51Existing Upstream License Agreements
Schedule 1.80Initial Collaboration Targets
Schedule 1.123Specifications
Schedule 2.10Expert Determination of [***]
Schedule 3.8Approved Subcontractors
Schedule 6.1.7Baseball-Style Arbitration
Schedule 7.6Pre-Existing License Terms
Schedule 8.3.3[***]
Schedule 10.4.1(a)No Adaptimmune Opt-In
Schedule 10.4.1(b)Adaptimmune Opt-In
Schedule 10.4.2Collaboration Personalised T-Cell Therapy Development Milestones
Schedule 14.1Press Release
Exhibit AAdaptimmune Differentiation Platform
Exhibit BResearch Plan
Exhibit CAdaptimmune Licensed Patent Rights
Exhibit DAdaptimmune Royalty Patent Rights
Exhibit EExample US Net Profit and Net Loss Calculation in Section 10.9.1
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STRATEGIC COLLABORATION AND LICENSE AGREEMENT
This Strategic Collaboration and License Agreement (“Agreement”) is made and entered into, as of September 3, 2021 (“Execution Date”), by and among Adaptimmune Limited, having its principal place of business at 60 Jubilee Avenue, Milton Park, Abingdon, Oxfordshire OX14 4RX, United Kingdom (“Adaptimmune”), on the one hand, and Genentech, Inc., a Delaware corporation, having its principal place of business at 1 DNA Way, South San Francisco, California 94080, United States (“GNE”), and F. Hoffmann-La Roche Ltd, having its principal place of business at Grenzacherstrasse 124, CH 4070 Basel, Switzerland (“Roche”), on the other hand. GNE and Adaptimmune are sometimes referred to herein individually as a “Party” and collectively as the “Parties.” The term “Party” or “Parties” shall not include Roche unless explicitly stated below.
BACKGROUND
WHEREAS, Adaptimmune is a biotechnology company that is engaged in the research and development of Cell Therapies (as defined below), including T-Cell receptor (“TCR”) based Cell Therapies (a “T-Cell Therapy”) for pharmaceutical therapy use.
WHEREAS, Adaptimmune is in the process of developing an allogeneic Manufacturing process for the generation of Allogeneic T-Cells (as defined below) from induced pluripotent stem cells.
WHEREAS, GNE is developing certain Receptors (as defined below), including TCRs and αβ Receptors (as defined below), for use in T-Cell Therapies.
WHEREAS, the Parties desire to collaborate to develop “off-the shelf” T-Cell Therapies and personalised T-Cell Therapies using αβ Receptors and αβ Allogeneic T-Cells.
WHEREAS, GNE desires to obtain an exclusive license and other rights from Adaptimmune to Research, Develop, Manufacture and Commercialize Collaboration Off-the-Shelf T-Cell Therapies and Collaboration Personalised T-Cell Therapies (each defined below), and Adaptimmune agrees to grant GNE such an exclusive license and other rights in exchange for certain agreed to upfront and other payments.
NOW THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, GNE, Roche and Adaptimmune agree as follows:
Capitalized terms used in this Agreement, whether used in the singular or plural, shall have the meanings set forth below, unless otherwise specifically indicated herein.
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[***].
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Additional Definitions
Defined Term | Section |
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“Adaptimmune” | Preamble |
Section 15.2.13 | |
Section 17.5.2 | |
Section 12.1.2 | |
Section 12.1.1 | |
Section 12.3.3 | |
Section 12.3.4 | |
Section 7.3.2(a) | |
Section 7.1.1(d) | |
Section 3.4.1 | |
Section 10.3.3 | |
Section 3.3.1 | |
“Agreement” | Preamble |
Section 2.7 | |
Section 3.5.1 | |
Section 3.5.1 | |
Section 10.3.2 | |
Section 3.8.1 | |
Section 11.7.5 | |
Section 12.2.3 | |
Section 12.1.3 | |
Section 6.1.3(b) |
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Defined Term | Section |
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Section 10.8.2 | |
Section 1.94 | |
Section 10.8.7(c) | |
Section 9.2.2 | |
“[***]” | Section 1.18 |
Section 10.3.2 | |
“[***]” | Section 8.3.3 |
“[***]” | Section 8.3.3 |
Section 7.1.1(b) | |
Section 8.3.1 | |
Section 8.3.1 | |
Section 7.1.1(c) | |
Section 8.3.2 | |
Section 8.3.2 | |
Section 3.4.2 | |
Section 1.99.2(b) | |
Section 9.2.1 | |
“control” | Section 1.18 |
Section 11.7.2 | |
Section 12.2.5 | |
Section 6.1.4 | |
Section 14.6.3 | |
Section 14.1 |
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Defined Term | Section |
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Section 10.10 | |
Section 19.1 | |
Section 12.4.3 | |
Section 9.1 | |
“Execution Date” | Preamble |
Section 2.9 | |
Section 17.6.6(c) | |
Section 1.79 | |
Section 6.1.2(a) | |
Section 9.1.2 | |
Section 9.1.2 | |
Section 1.61 | |
Section 1.61 | |
“[***]” | Section 1.18 |
“[***]” | Section 1.18 |
Section 20.7 | |
Section 1.3 | |
Section 11.6.2 | |
Section 11.6.2 | |
Section 1.64 | |
“GNE” | Preamble |
Section 17.6.6(g) | |
Section 12.1.4 |
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Defined Term | Section |
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Section 12.1.5 | |
Section 12.3.4 | |
Section 12.1.6 | |
Section 12.3.3 | |
Section 7.3.2(a) | |
Section 10.8.7(a) | |
Section 10.8.7(a) | |
Section 7.2.1(b) | |
Section 1.3 | |
Section 16.2 | |
Section 16.2 | |
Section 12.4.1 | |
Section 3.3.1 | |
Section 6.1.2(a) | |
Section 1.112 | |
Section 10.3.2(b) | |
Section 2.4.1 | |
Section 2.3 | |
Section 2.2.1 | |
Section 2.1.1 | |
[***] | Section 12.1.7 |
[***] | Section 12.1.7 |
Section 6.1.4 |
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Defined Term | Section |
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Section 16.1.1 | |
Section 1.94 | |
Section 17.6.6(d) | |
Section 11.2 | |
Section 6.1.8(d) | |
Section 1.79 | |
Section 3.6.1 | |
Section 14.6.3 | |
Section 13.5 | |
Section 17.4.2 | |
Section 17.5.1 | |
Section 17.6.6(a) | |
Section 10.4.1 | |
Section 10.4.1 | |
Section 9.1.1 | |
Section 10.5.1 | |
Section 10.5.1 | |
Section 6.1.8(d) | |
Section 17.6.6(b) | |
Section 12.4.2 | |
Section 6.1.1 | |
Section 6.1.2(a) | |
Section 6.1.8(b) |
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Defined Term | Section |
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Section 6.1.2(b) | |
Section 6.1.8(a) | |
Section 6.1.8(a) | |
Section 12.1.8 | |
Section 6.1.5 | |
“Overlapping Improvement IP” | Section 12.1.9 |
Section 12.2.3 | |
“Party” | Preamble |
Section 2.5.7(c) | |
Section 12.9 | |
“[***]” | Section 7.2.1(c) |
Section 10.4.2 | |
Section 10.4.2 | |
Section 9.1.2 | |
Section 10.5.2 | |
Section 10.5.2 | |
Section 4.6 | |
Section 8.1.1 | |
Section 8.1.2 | |
Section 4.3 | |
Section 2.2.1 | |
Section 3.6.1 | |
Section 8.1.3 |
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Defined Term | Section |
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Section 17.6.6(b) | |
“Relevant Collaboration Target IP” | Section 17.6.6(d)(i) |
Section 3.4.2 | |
Section 3.2 | |
Section 3.1 | |
Section 8.1.1 | |
Section 3.3.1 | |
Section 10.2 | |
Section 17.6.6(d)(i) | |
Section 17.6.6(b) | |
“Roche” | Preamble |
Section 19.2.1 | |
“[***]” | Section 12.1.7 |
Section 1.94 | |
Section 1.61 | |
Section 1.61 | |
Section 6.1.4 | |
Section 1.94 | |
Section 12.3.1 | |
“[***]” | Section 1.18 |
Section 3.6.2(b) | |
Section 12.9 | |
Section 2.2.3 |
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Defined Term | Section |
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Section 7.1.4(a) | |
Section 7.1.4(a) | |
Section 3.6.1 | |
Background | |
Background | |
Section 8.4 | |
Section 17.1 | |
Section 16.1.1 | |
Section 12.5.1 | |
“Third Party IP” | Section 7.3.1 |
Section 10.8.1 | |
Section 7.3.1 | |
Section 17.3 | |
Section 17.6.6(d) | |
“US-only Development Costs” | Section 6.1.4(b) |
Section 6.1.7 | |
Section 6.1.7 | |
Section 6.1.3(a) | |
Section 6.1.1 | |
Section 10.8.7(d) |
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For clarity, the restrictions set out in Section 9.1.1 (Off-the-Shelf T-Cell Therapy) or Section 9.1.2 (Personalised T-Cell Therapy) shall not prevent Adaptimmune from Researching, Developing, Manufacturing or Commercializing (a) autologous Cell Therapies save where such Cell Therapies are Directed To a Collaboration Target; (b) Cell Therapies Manufactured or Developed from an iPS Cell and comprising Receptors engineered to be Directed To Targets other than Collaboration Targets; or (c) [***].
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Event | Payment Amount |
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[***] | [***] |
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Event | Payment Amount |
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[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
Event | Payment Amount |
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[***] | [***] |
[***] | [***] |
For purposes of this Section 10.3.2 (Research Milestone Payments):
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Personalised Net Sales Milestone Event | Personalised Net Sales Milestone Payment |
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When worldwide Annual Net Sales for all Collaboration Personalised T-Cell Therapies [***] | $[***] |
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Personalised Net Sales Milestone Event | Personalised Net Sales Milestone Payment |
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When worldwide Annual Net Sales for all Collaboration Personalised T-Cell Therapies [***] | |
When worldwide Annual Net Sales for all Collaboration Personalised T-Cell Therapies [***] | |
When worldwide Annual Net Sales for all Collaboration Personalised T-Cell Therapies [***] | $[***] |
Total amount payable for achieving all Personalised Net Sales Milestone Events | $[***] |
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[***] | [***] |
Ex-US Annual Net Sales of all Collaboration Off-the-Shelf T-Cell Therapies for a Given Collaboration Target (in US Dollars; Adaptimmune Opt-In) | Royalty Rate |
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[***] | [***] |
[***] | [***] |
[***] | [***] |
Aggregate Worldwide Annual Net Sales of Collaboration Personalised T-Cell Therapies (in US Dollars) | Royalty Rate |
[***] | [***] |
[***] | [***] |
[***] | [***] |
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11.2.1.[***];
11.2.2.[***];
11.2.3.[***]
11.2.4.[***].
If GNE is reporting Net Sales for more than one Licensed Product, the foregoing information shall be reported on a Licensed Product-by-Licensed Product basis. Where no payment is due, GNE shall also deliver a report indicating such.
[***]
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For the avoidance of doubt, if any settlement results in the granting to the person or entity accused of infringement or misappropriation of a sublicense of any of the Collaboration IP from GNE with running royalties payable on post-settlement sales by the alleged infringer, such alleged infringer shall be deemed to be a Sublicensee of GNE and such royalties on post-settlement sales: (i) shall be subject to all applicable royalty obligations hereunder; and (ii) shall not be subject to this Section 12.4.5 (Damages); provided, that any upfront or event payments or the like shall be deemed monetary awards and subject to Section 12.4.5(b) (Damages). In the event the sublicense agreement includes other Intellectual Property that is not a subject of this Agreement, then unless allocation of payments to Collaboration IP is clear within agreement then GNE shall have the right, in its reasonable discretion, to apportion such upfront, event payments or royalties pro-rata between such other Intellectual Property and any of the Collaboration IP.
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except in the case of clauses (a) through (e) above, for those Losses for which Adaptimmune has an obligation to indemnify GNE pursuant to Section 16.1.2 (Indemnification of GNE), as to which Losses each Party shall indemnify the other to the extent of their respective liability for the Losses.
except, in the case of clauses (a) through (d) above, for those Losses for which GNE has an obligation to indemnify Adaptimmune pursuant to Section 16.1.1 (Indemnification of Adaptimmune), as to which Losses each Party shall indemnify the other to the extent of their respective liability for the Losses.
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If GNE determines that an HSR Filing is necessary, each Party shall, within ten (10) Business Days of the Execution Date (or such later time as may be agreed to in writing by the Parties), file with the United States Federal Trade Commission and the Antitrust Division of the United States Department of Justice, or with equivalent foreign authorities, any HSR Filing required of it under the HSR Act or applicable antitrust or competition laws of other jurisdictions with respect to the transactions contemplated hereby. The Parties shall seek expedited treatment of any HSR Filing unless otherwise agreed by the Parties in writing. Each Party will use reasonable efforts to do, or cause to be done, all things necessary or advisable to, as promptly as practicable, take all actions necessary to make the filings required of such Party or its Affiliates under the HSR Act and obtain the requisite Governmental Required Consents. The Parties shall cooperate with one another to the extent necessary in the preparation of any such HSR Filing. GNE shall be responsible for the filing fees associated with any HSR Filing. Each Party shall be responsible for all of its other own costs and expenses associated with any HSR Filing, including its own attorneys’ fees and associated costs and expenses. If the Parties make an HSR Filing under this Agreement, then this Agreement shall terminate: (i) at the election of either Party, immediately upon written notice to the other Party, if the US Federal Trade Commission or the US Department of Justice, or an equivalent foreign authority, seeks a preliminary injunction under the applicable antitrust laws against the Parties to enjoin the transactions contemplated by this Agreement; or (ii) at the election of either Party, immediately upon written notice to the other Party, in the event that the HSR Clearance Date shall not have occurred on or prior to one hundred eighty (180) days after the effective date of the HSR Filing. In the event of such termination, this Agreement shall be of no further force and effect.
For GNE – A Vice President
For Adaptimmune – Chief Executive Officer
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In the event the designated officers, or their respective designees, are not able to resolve such dispute within [***] days of such other Party’s receipt of such written notice, either Party may initiate the dispute resolution procedures set forth in Section 19.2 (Arbitration).
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If to GNE: | [***] |
with required copies (which shall not constitute notice) to:
[***]
If to Adaptimmune: | [***] |
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[Signature page follows – the rest of this page intentionally left blank.]
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IN WITNESS WHEREOF, Adaptimmune, GNE and Roche have executed this Agreement by their respective officers hereunto duly authorized, on the Execution Date.
ADAPTIMMUNE LIMITED
By: /s/ Adrian Rawcliffe
Name: Adrian Rawcliffe
Title: Director and CEO
GENENTECH, INC.
By: /s/ Edward Harrington
Name:Edward Harrington
Title: CFO
F. HOFFMANN-LA ROCHE LTD
By: /s/ Vikas Kabra By: /s/ Barbara Schroeder _________
Name: Vikas Kabra Name: Barbara Schroeder _________
Title: Global Head Transaction Excellence Title: _Authorized Signatory________
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Schedule 1.80
Initial Collaboration Targets
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Schedule 2.10
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Schedule 3.8
Approved Subcontractors
[***]
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Schedule 7.6
Pre-Existing License Terms
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Schedule 10.4.1(a)
No Adaptimmune Opt-In
Off-the-Shelf Development Milestone Event | Off-the-Shelf Development Milestone Payment (US Dollars) |
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[***] | |
[***] | [***] |
[***] | [***] |
[***] | [***] |
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[***] | [***] |
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[***] | [***] |
[***].
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Schedule 10.4.1(b)
Adaptimmune Opt-In
Off-the-Shelf Development Milestone Event | Off-the-Shelf Development Milestone Payment (US Dollars) |
[***] | |
[***] | [***] |
[***] | |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***].
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Schedule 10.4.2
Collaboration Personalised T-Cell Therapy Development Milestones
Personalised Development Milestone Event | Milestone Payment |
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[***] | |
[***] | [***] |
[***] | |
[***] | [***] |
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Adaptimmune Off-the-Shelf Royalty Patent Rights
Adaptimmune Personalised Royalty Patent Rights
Title | Country | Application no. | Filing date | Adaptimmune reference |
[***] | [***] | [***] | [***] | [***] |
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GNE | Adaptimmune | Total | |
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