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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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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