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As Of Filer Filing For·On·As Docs:Size Issuer Filing Agent 2/27/20 Adaptimmune Therapeutics PLC 10-K 12/31/19 118:15M Toppan Merrill Bridge/FA |
Document/Exhibit Description Pages Size
1: 10-K Annual Report HTML 1.85M
2: EX-4.4 Instrument Defining the Rights of Security Holders HTML 124K
3: EX-10.4 Material Contract HTML 468K
4: EX-10.5 Material Contract HTML 852K
5: EX-10.6 Material Contract HTML 61K
6: EX-23.1 Consent of Experts or Counsel HTML 34K
7: EX-31.1 Certification -- §302 - SOA'02 HTML 41K
8: EX-31.2 Certification -- §302 - SOA'02 HTML 41K
9: EX-32.1 Certification -- §906 - SOA'02 HTML 34K
10: EX-32.2 Certification -- §906 - SOA'02 HTML 34K
94: R1 Document and Entity Information HTML 93K
58: R2 Consolidated Balance Sheets HTML 110K
19: R3 Consolidated Balance Sheets (Parenthetical) HTML 48K
81: R4 Consolidated Statements of Operations HTML 73K
93: R5 Consolidated Statements of Operations HTML 33K
(Parenthetical)
57: R6 Consolidated Statements of Comprehensive Loss HTML 58K
18: R7 Consolidated Statements of Comprehensive Loss HTML 45K
(Parenthetical)
80: R8 Consolidated Statements of Changes in Equity HTML 88K
95: R9 Consolidated Statement of Change in Equity HTML 41K
(Parenthetical)
52: R10 Consolidated Statements of Cash Flows HTML 109K
39: R11 Consolidated Statements of Cash Flows HTML 36K
(Parenthetical)
75: R12 General HTML 37K
114: R13 Summary of Significant Accounting Policies HTML 290K
53: R14 Revenue HTML 67K
40: R15 Financial instruments HTML 102K
76: R16 Other current assets HTML 48K
115: R17 Property, plant and equipment, net HTML 53K
54: R18 Intangible assets, net HTML 47K
38: R19 Operating Leases HTML 68K
83: R20 Accrued expenses and other current liabilities HTML 53K
96: R21 Contingencies and commitments HTML 62K
55: R22 Stockholders' equity HTML 39K
16: R23 Share-based compensation HTML 235K
84: R24 Income taxes HTML 149K
97: R25 Geographic information HTML 48K
56: R26 Subsequent event HTML 36K
17: R27 Summary of Significant Accounting Policies HTML 350K
(Policies)
82: R28 Summary of Significant Accounting Policies HTML 226K
(Tables)
98: R29 Revenue (Tables) HTML 67K
118: R30 Financial instruments (Tables) HTML 96K
78: R31 Other current assets (Tables) HTML 48K
37: R32 Property, plant and equipment, net (Tables) HTML 53K
51: R33 Intangible assets, net (Tables) HTML 47K
117: R34 Operating Leases (Tables) HTML 69K
77: R35 Accrued expenses and other current liabilities HTML 49K
(Tables)
36: R36 Share-based compensation (Tables) HTML 191K
50: R37 Income taxes (Tables) HTML 151K
116: R38 Geographic information (Tables) HTML 47K
79: R39 General (Details) HTML 35K
101: R40 Summary of Significant Accounting Policies - Going HTML 74K
concern (Details)
87: R41 Summary of Significant Accounting Policies - HTML 35K
Foreign currency (Details)
27: R42 Summary of Significant Accounting Policies - HTML 36K
Accumulated other comprehensive income (Loss)
(Details)
67: R43 Summary of Significant Accounting Policies - Cash, HTML 44K
cash equivalents and restricted cash (Details)
100: R44 Summary of Significant Accounting Policies - HTML 115K
Available-for-sale debt securities (Details)
85: R45 Summary of Significant Accounting Policies - HTML 39K
Accounts receivable (Details)
26: R46 Summary of Significant Accounting Policies - HTML 42K
Property, plant and equipment (Details)
66: R47 Summary of Significant Accounting Policies - HTML 35K
Intangibles (Details)
99: R48 Summary of Significant Accounting Policies - HTML 34K
Leases (Details)
88: R49 Summary of Significant Accounting Policies - HTML 34K
Segment Reporting (Details)
69: R50 Summary of Significant Accounting Policies - HTML 40K
Revenue from contract with customers (Details)
106: R51 Summary of Significant Accounting Policies - HTML 36K
Research and Development Expenditure (Details)
48: R52 Summary of Significant Accounting Policies - HTML 34K
Retirement Benefits (Details)
34: R53 Summary of Significant Accounting Policies - Loss HTML 43K
per share (Details)
70: R54 Summary of Significant Accounting Policies - HTML 36K
Antidilutive Securities (Details)
107: R55 Summary of Significant Accounting Policies - HTML 39K
Options (Details)
49: R56 Summary of Significant Accounting Policies - New HTML 43K
accounting pronouncements (Details)
35: R57 Revenue (Details) HTML 37K
68: R58 Revenue - Revenue from contracts with customers HTML 39K
(Details)
108: R59 Revenue - Deferred revenue (Details) HTML 51K
60: R60 Financial instruments - Fair value of assets and HTML 57K
liabilities (Details)
22: R61 Financial instruments - Cash Equivalents and HTML 42K
Short-term Deposits (Details)
89: R62 Financial instruments - Collaboration and License HTML 44K
Agreement (Details)
102: R63 Financial instruments - Foreign Exchange Risk HTML 34K
(Details)
63: R64 Other current assets (Details) HTML 48K
25: R65 Property, plant and equipment, net - Schedule of HTML 53K
Property and Equipment (Details)
92: R66 Property, plant and equipment, net - Depreciation HTML 35K
Expense (Details)
105: R67 Intangible assets, net - Tabular Disclosure HTML 44K
(Details)
64: R68 Intangible assets, net - Amortization Expense HTML 35K
(Details)
21: R69 Intangible assets, net - Aggregate Amortization HTML 45K
Expense (Details)
31: R70 Operating Leases - Lease Cost (Details) HTML 47K
47: R71 Operating Leases - Maturities (Details) HTML 51K
112: R72 Accrued expenses and other current liabilities HTML 49K
(Details)
74: R73 Accrued expenses and other current liabilities - HTML 45K
Supply agreement (Details)
28: R74 Contingencies and commitments - Operating Leases HTML 48K
(Details)
44: R75 Contingencies and commitments - Capital HTML 37K
Commitments (Details)
109: R76 Contingencies and commitments - Clinical Trials HTML 49K
and Contract Manufacturing Commitments (Details)
71: R77 Contingencies and commitments - Collaborations and HTML 86K
License Agreements (Details)
33: R78 Stockholders' equity - Ordinary Shares (Details) HTML 42K
43: R79 Stockholders' equity - Underwritten public HTML 50K
offering and Registered direct offering (Details)
30: R80 Share-based compensation - Option Plans (Details) HTML 146K
46: R81 Share-based compensation - Share-based HTML 40K
Compensation Expense (Details)
111: R82 Share based compensation - Unrecognized HTML 37K
Compensation Cost (Details)
73: R83 Share-based compensation - Options (Details) HTML 43K
29: R84 Share based compensation - Option Activity HTML 91K
(Details)
45: R85 Share based compensation - Stock Options HTML 83K
Outstanding (Details)
110: R86 Share based compensation - Options Exercised HTML 44K
(Details)
72: R87 Share-based compensation - Fair Value Assumptions HTML 47K
(Details)
32: R88 Income taxes - Income before Income Taxes HTML 41K
(Details)
41: R89 Income taxes - Components of Income Tax Expense HTML 46K
(Benefit) (Details)
61: R90 Income taxes - Reconciliation of Deferred Tax HTML 67K
Assets and Liabilities (Details)
23: R91 Income taxes - Change in Valuation Allowance HTML 43K
(Details)
90: R92 Income taxes - Reconciliation of Effective Tax HTML 61K
Rate (Details)
103: R93 Income taxes - Tax Rates (Details) HTML 37K
62: R94 Income taxes - Change in Tax Rate (Details) HTML 60K
24: R95 Income taxes - Unrecognized Tax Benefits (Details) HTML 34K
91: R96 Geographic information - Operations by Geographic HTML 40K
Area - Long-lived Assets (Details)
104: R97 Geographic information - Major Customers (Details) HTML 41K
65: R98 Subsequent events (Details) HTML 49K
20: XML IDEA XML File -- Filing Summary XML 215K
59: XML XBRL Instance -- adap-20191231x10kb99908_htm XML 2.90M
86: EXCEL IDEA Workbook of Financial Reports XLSX 118K
12: EX-101.CAL XBRL Calculations -- adap-20191231_cal XML 202K
13: EX-101.DEF XBRL Definitions -- adap-20191231_def XML 694K
14: EX-101.LAB XBRL Labels -- adap-20191231_lab XML 1.63M
15: EX-101.PRE XBRL Presentations -- adap-20191231_pre XML 1.23M
11: EX-101.SCH XBRL Schema -- adap-20191231 XSD 239K
42: JSON XBRL Instance as JSON Data -- MetaLinks 407± 653K
113: ZIP XBRL Zipped Folder -- 0001558370-20-001571-xbrl Zip 665K
| adap_Ex10_6 |
Exhibit 10.6
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY [***], HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
EXECUTION VERSION
AMENDMENT NO. 1 TO COMMERCIAL DEVELOPMENT AND SUPPLY AGREEMENT and LICENSE
AGREEMENT
This Amendment No. 1 to Commercial Development and Supply Agreement (“Amendment No. 1”) effective as of 18 November, 2019 (“Amendment No. 1 Effective Date”) is entered into by and between ADAPTIMMUNE Limited, with offices at 60 Jubilee Avenue (formerly 101 Park Drive), Milton Park, Abingdon, Oxon, OX14 4RX, England (“ADAPTIMMUNE”) and Life Technologies Corporation, an Affiliate of Thermo Fisher Scientific Inc., with offices at 5781 Van Allen Way (formerly 5791), Carlsbad, California 92008 (“LIFE”). and amends the Commercial Development and Supply Agreement effective as of June 1, 2016 entered into by ADAPTIMMUNE and LIFE (“Supply Agreement”). ADAPTIMMUNE and LIFE each hereinafter a “Party” and collectively “Parties”.
WHEREAS, the Parties entered into a Commercial Development and Supply Agreement effective as of June 1, 2016 (“Supply Agreement”) and also into a License Agreement and Sublicense Agreement effective as of 19 December 2012 (together “License Agreements”);
WHEREAS the Parties now wish to amend the terms of the Supply Agreement and License Agreements as specified in this Amendment No. 1.
NOW, THEREFORE, in consideration of the mutual promises contained in this Amendment No. 1 and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
1. The following amendments shall be made to the Supply Agreement:
a. Amend definition of Development Phase Purchasing Obligation: The definition of “Development Phase Purchasing Obligation” is hereby deleted and replaced in its entirety by the following:
“The minimum purchasing obligation applicable during the Development Phase shall be as follows: [***]”
b. Amend definition of Minimum Purchasing Obligation: The definition of “Minimum Purchasing Obligation” is hereby deleted and replaced in its entirety by the following:
“The minimum purchasing obligation is defined by the Development Phase Purchasing Obligation. The minimum purchasing obligation applicable during the Commercial Phase shall be mutually agreed during the Transitional Phase with both Parties acting in good faith but shall be [***] in the Commercial Phase.”
c. Amend Appendix A Supply Terms and Conditions: The following provisions of the Supply Terms and Conditions (Appendix A) are hereby deleted and restated as follows:
i. 1A.2: “At any time after the Amendment No. 1 Effective Date, Customer may notify Life that it wishes to enter into the Commercial Phase. The Commercial
EXECUTION VERSION
Phase Notification will specify when Customer wishes the Commercial Phase to start and its forecasted orders for Products”
ii. 1.1: Clause 1.1 shall be deleted in its entirety and there shall be no requirement for Customer to exclusively purchase Customer’s needs for all CD3/CD28 magnetic bead products from Life.
iii. 1.3: Clause 1.3 will be deleted and replaced with the following: “Products will be supplied under the Limited Use Label Licenses at Exhibit E-1, E-2 and E-3. The applicable LULL shall be determined by the SKU for the relevant Product and the current Phase save that the LULL at E-3 will apply to any manufacture and supply of Customer’s cell therapy using Products from the Initial Order for treatment of sarcoma irrespective of the Phase.”
iv. 2.1: “Binding Purchase Order: Customer shall provide Life with a binding purchase order for the binding element of each rolling forecast for the amount of Products specified by Customer. For clarity, purchase orders may only be placed for Products under [***] during the [***] and [***] and may only be placed for Products under [***] during the [***]. Except for the Development Phase Purchasing Obligation, as part of any other purchase order during the Development Phase, Customer may specify [***] in relation to such order provided such [***] does not extend over a period of more than [***] from first delivery under such purchase order.”
v. 2.2: “Rolling forecast: On or before July 1 of each calendar year of this Agreement, Customer shall submit a [***] written forecast to Life, which shall specify the estimated number of vials of Products required by Customer. The [***] of such forecast will be binding on Customer. For the purposes of this Amendment, this forecasting mechanism shall commence on [***] with binding element applicable [***] and be in effect for the Term of the Supply Agreement.”
vi. 9.2: “Life shall have the right to adjust the price for the Products [***] (first commencing [***]; provided, however, that increases in the price from [***]. Life shall confirm the Price of Products applicable from commencement of the Commercial Phase during the Transitional Phase and as soon as reasonably possible after start of Transitional Phase. In confirming such Price, Life shall act reasonably and shall not [***]”
d. Amend definition of Batch. The definition of “Batch” in Appendix B is hereby deleted.
e. Amend definition of Current Manufacturing Process. The definition of “Current Manufacturing Process” in Appendix B is hereby deleted and replaced in its entirety by the following: ““Current Manufacturing Process” means the Product manufacturing process in place as at the Effective Date.”
f. Amend Appendix D. Appendix D of the Supply Agreement is amended as follows:
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SKU |
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Minimum Annual |
Single Order |
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Development Phase and Transitional Phase supply (unless otherwise agreed)
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2
EXECUTION VERSION
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43300D |
Dynabeads· CD3/CD28 |
[***] |
[***] |
[***] |
2. The following amendments shall be made to the License Agreements.
a. Change from Exclusive to Non-exclusive under the LTC-ADAPTIMMUNE License Agreement: As of the Amendment No. 1 Effective Date, clause 2.1(a) and clause 2.1(b) and shall be amended such that any reference to an exclusive license is replaced with a non-exclusive license.
b. Change to Sublicense Agreement. As of the Amendment No. 1 Effective Date clause 2.1(a) shall be amended such that any reference to an exclusive license is replaced with a non-exclusive license.
c. For the avoidance of doubt amendments under this Section include the terms of any and all Limited Use Label Licenses (“LULL(s)”), including but not limited to those LULL’s listed in Appendix E of the Supply Agreement.
d. Change to remove obligations and restrictions related to exclusivity under the LTC-ADAPTIMMUNE License Agreement: Any and all obligations and/or restrictions on LTC related to the LTC Bead and LTC Engineered T Cell Receptor products and imposing a requirement for exclusivity or exclusivity of supply on LTC, including, but not limited to, Sections 3.11 and 3.12 of the LTC-ADAPTIMMUNE License Agreement, are hereby deleted in their entirety.
e. Change to remove obligations and restrictions on LTC relating to exclusivity under the Sublicense Agreement: Any and all obligations and/or restrictions on LTC related to the LTC Bead and LTC Engineered T Cell Receptor products and imposing a requirement for exclusivity or exclusivity of supply on LTC, including, but not limited to Sections 3.10 and 3.11 of the Sublicense Agreement, are hereby deleted in their entirety.
3. Capitalized words used but not defined in this Amendment No. 1 shall have the meaning ascribed to them in the Supply Agreement.
4. This Amendment shall be governed by, and construed in accordance with, the laws which govern the Supply Agreement, and the Parties submit to the jurisdiction and dispute resolution provisions as set forth in the Supply Agreement.
5. Except as amended and supplemented herein, all terms and provisions of the Supply Agreement shall remain unchanged and in full force and effect. This Amendment shall hereafter be incorporated into and deemed part of the Agreement and any future reference to the Agreement shall include the terms and conditions of this Amendment. No alteration or amendment to this Amendment No. 1 shall be binding on any Party hereto unless reduced to writing and signed by both Parties.
6. This Amendment No. 1 may be executed (including via facsimile signatures) by the Parties in counterparts, each of which when so executed and delivered shall be deemed to be an original, but all of which shall constitute one and the same agreement, binding on the Parties as if each had signed the same document.
3
EXECUTION VERSION
IN WITNESS WHEREOF, the Parties hereto have hereby duly executed this Amendment No. 1 as of the date of last signature below. This Amendment No. 1 shall be effective as of the Amendment No. 1 Effective Date.
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Life Technologies Corporation |
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ADAPTIMMUNE Limited |
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Kate Torchilin |
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John Lunger |
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Name |
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Name |
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VP & GM of Cell Culture & Cell Therapy |
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Chief Patient Supply Officer |
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Title |
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Title |
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/s/ Kate Torchilin |
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/s/ John Lunger |
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Signature |
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Signature |
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November 23, 2019 |
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November 20, 2019 |
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4
| This ‘10-K’ Filing | Date | Other Filings | ||
|---|---|---|---|---|
 | ||||
| Filed on: | 2/27/20 | 8-K | ||
| For Period end: | 12/31/19 | |||
| 11/23/19 | 8-K | |||
| 11/20/19 | ||||
| 6/1/16 | ||||
| List all Filings | ||||
As Of Filer Filing For·On·As Docs:Size Issuer Filing Agent 3/06/24 Adaptimmune Therapeutics plc 10-K 12/31/23 131:16M Toppan Merrill Bridge/FA 4/18/23 Adaptimmune Therapeutics plc S-4/A 7:5.6M Toppan Merrill/FA 4/05/23 Adaptimmune Therapeutics plc S-4 7:4.5M Toppan Merrill/FA 3/06/23 Adaptimmune Therapeutics plc 10-K 12/31/22 117:15M Toppan Merrill Bridge/FA 3/14/22 Adaptimmune Therapeutics plc 10-K 12/31/21 109:13M Toppan Merrill Bridge/FA 2/25/21 Adaptimmune Therapeutics plc 10-K 12/31/20 112:13M Toppan Merrill Bridge/FA 8/10/20 Adaptimmune Therapeutics plc S-3ASR 8/10/20 5:1.6M Toppan Merrill/FA |