COLLABORATION AND EXCLUSIVE LICENSE AGREEMENT
Exhibit 10.2
Collaboration and Exclusive License Agreement
FINAL
(***) CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN EXCLUDED PURSUANT TO REGULATION S-K, ITEM 601(B)(10). SUCH EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
COLLABORATION AND EXCLUSIVE LICENSE AGREEMENT
between
ADAPTIMMUNE Limited
and
GALAPAGOS NV
Dated as of 30 May 2024
ACTIVE/130546626.2
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COLLABORATION AND EXCLUSIVE LICENSE AGREEMENT
This Collaboration and Exclusive License Agreement (“Agreement”) is effective as of 30 May 2024 (“Effective Date”) made by and between Adaptimmune Limited, having offices at 00 Xxxxxxx Xxxxxx, Xxxxxx Xxxx, Xxxxxxxx, Xxxxxxxxxxx XX00 0XX, XX (“Adaptimmune”), and Galapagos NV, having offices at Generaal De Wittelaan L11 A3, 2800 Mechelen, Belgium (“Galapagos”). Each of Galapagos and Adaptimmune may be referred to in this Agreement individually as a “Party” or together as the “Parties.”
RECITALS
WHEREAS, Galapagos is a biopharmaceutical company focusing on developing biologic treatments in oncology (amongst others);
WHEREAS, Adaptimmune is a biotechnology company that is engaged in the research and development of cell therapies, including T-cell receptor based cell therapies for pharmaceutical therapy use;
WHEREAS, Adaptimmune is currently developing the Adaptimmune Product, which contains the Licensed TCR, in the SURPASS family of Clinical Trials;
WHEREAS, the Parties desire to collaborate to develop a T-cell therapy product manufactured using the Galapagos Manufacturing Platform and containing the Licensed TCR; and
WHEREAS, Galapagos desires to obtain an exclusive option to be granted an exclusive license and other rights from Adaptimmune to Develop, Manufacture, Commercialize, and otherwise Exploit Licensed Products, and Adaptimmune agrees to grant Galapagos such an exclusive option to be granted and exclusive license and other rights in exchange for certain agreed to upfront and other payments.
NOW, THEREFORE, the Parties hereby agree as follows:
AGREEMENT
| 1.1 | “Accounting Standard” means (a) International Financial Reporting Standards or (b) GAAP, in each case ((a) or (b)), consistently applied throughout the applicable Party’s organization. |
| 1.2 | “Acquirer” has the meaning set forth in Section 1.29 (Change of Control). |
| 1.3 | “Adaptimmune” has the meaning set forth in the preamble. |
| 1.5 | “Adaptimmune CD8 IP” means the Adaptimmune CD8 Know-How and the Adaptimmune CD8 Patent Rights. |
| 1.6 | “Adaptimmune CD8 Know-How” means all Know-How Controlled by Adaptimmune or any of its Affiliates as of the Effective Date or during the Term (including all Know-How included in the |
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| Adaptimmune Background IP and Adaptimmune Platform Improvement IP, and Adaptimmune’s interest in the Know-How included in the Other Collaboration IP) that is provided or otherwise made available by or on behalf of Adaptimmune or its Affiliates to Galapagos or its Affiliates under this Agreement (as part of the Collaboration Deliverables or otherwise), and that directly relates to the Licensed Product. |
| 1.8 | “Adaptimmune Collaboration Activities” has the meaning set forth in Section 2.3.2 (Adaptimmune Collaboration Activities). |
| 1.9 | “Adaptimmune Indemnitees” has the meaning set forth in Section 15.2 (Indemnification by Galapagos). |
| 1.10 | “Adaptimmune Manufacturing IP” means the Adaptimmune Manufacturing Know-How and the Adaptimmune Manufacturing Patent Rights. |
| 1.14 | “Adaptimmune Platform Improvement IP” means any Collaboration IP that (***). |
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| 1.16 | “Adaptimmune Product Rights” has the meaning set forth in Section 4.5.2(a) (Retained Adaptimmune Product Rights). |
| 1.17 | “Adaptimmune Prosecuted Patent Rights” has the meaning set forth in Section 11.2.3 (Adaptimmune). |
| 1.18 | “Adaptimmune Step-In Right” has the meaning set forth in Section 11.2.4 (Galapagos). |
| 1.19 | “Adaptimmune Study Conduct Team” means the internal Adaptimmune working group established by Adaptimmune in accordance with its internal standard operating procedures to oversee the conduct of the Collaboration Trial. |
| 1.21 | “Agreement” has the meaning set forth in the preamble. |
| 1.22 | “Alliance Manager” has the meaning set forth in Section 6.1 (Alliance Managers). |
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| 1.25 | “Breaching Party” has the meaning set forth in Section 14.2.2 (Material Breach). |
| 1.26 | “Business Day” means a day other than a Saturday, Sunday, or a bank or other public holiday in Boston, Massachusetts, London, England, or Brussels, Belgium. |
| 1.27 | “Buyers” has the meaning set forth in Section 1.113 (Net Sales). |
| 1.30 | “Clinical Supply Agreement” has the meaning set forth in Section 9.1.3 (Clinical Supply Agreement). |
| 1.31 | “Clinical Trial” means any clinical trial in humans, including clinical trials designed to generate data to address a commitment or requirement under a Regulatory Approval. |
| 1.32 | “Collaboration” means all activities set forth in the Collaboration Plan, or otherwise arising in the performance of the Collaboration Trial, including the performance of regulatory and pre-clinical activities to enable the performance of the Collaboration Trial, and the Manufacture and supply of the Licensed TCR Vector and the Collaboration Product for the performance of the Collaboration Trial. |
| 1.33 | “Collaboration Activities” has the meaning set forth in Section 2.3.2 (Adaptimmune Collaboration Activities). |
| 1.34 | “Collaboration Deliverables” means the agreed data, materials, results, information, and other deliverables set forth in the Collaboration Plan, or otherwise arising in the performance of the Collaboration Activities. |
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| Patent Rights to a Party or any Affiliate of a Party, whether alone or jointly with the other Party or its Affiliates or its or their licensees, Sublicensees, or Subcontractors, or any persons contractually required to assign or license such Know-How and Patent Rights to the other Party or any Affiliate of the other Party, in each case, as a result of the performance of the Collaboration. |
| 1.36 | “Collaboration License” has the meaning set forth in Section 4.1 (Mutual Collaboration License Grant). |
| 1.37 | “Collaboration Period” means the period of time beginning upon the Effective Date and expiring on the date that the last Collaboration Deliverable is delivered. |
| 1.38 | “Collaboration Plan” has the meaning set forth in Section 2.2.1 (Collaboration Plan). |
| 1.40 | “Collaboration Results” means any and all data, information, materials and results generated as a result of the performance of the Collaboration, including any and all descriptions of experiments conducted as part of the Collaboration and corresponding analyses and conclusions. |
| 1.41 | “Collaboration Trial” means the Phase 1 Clinical Trial designed to assess the use of the Collaboration Product for the treatment of head and neck cancers as set forth in the Collaboration Plan. |
| 1.42 | “Collaboration Trial Data Package” means a report and data package containing the information specified in Schedule 1.42 (Collaboration Trial Data Package). |
| 1.43 | “Combination” has the meaning set forth in Section 1.113 (Net Sales). |
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| reference pricing), the likely timing of the product’s entry into the market, the patent and other proprietary position, and other relevant scientific, technical, and commercial factors. |
| 1.46 | “Confidential Information” has the meaning set forth in Section 12.1 (Confidential Information). |
| 1.47 | “Confidentiality Agreement” has the meaning set forth in Section 12.2 (Duty of Confidence). |
| 1.50 | “CREATE Act” has the meaning set forth in Section 11.1.3 (CREATE Act). |
| 1.52 | “Development Fee” has the meaning set forth in Section 10.2 (Development Fee). |
| 1.53 | “Development Milestone Event” has the meaning set forth in Section 10.4.1(a) (Development Milestone Events and Payments). |
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| 1.54 | “Development Milestone Payment” has the meaning set forth in Section 10.4.1(a) (Development Milestone Events and Payments). |
| 1.55 | “Disclosing Party” has the meaning set forth in Section 12.1 (Confidential Information). |
| 1.56 | “Dispute” has the meaning set forth in Section 16.3.1 (Disputes). |
| 1.57 | “Divisional Patent Application” has the meaning set forth in Section 11.2.5 (Divisional Patent Rights). |
| 1.58 | “Divisional Patent Rights” has the meaning set forth in Section 11.2.5 (Divisional Patent Rights). |
| 1.59 | “Dollar” means the U.S. dollar, and “$” will be interpreted accordingly. |
| 1.60 | “Effective Date” has the meaning set forth in the preamble. |
| 1.61 | “EMA” means the European Medicines Agency and any successor Governmental Authority having substantially the same function. |
| 1.62 | “Endpoint” means with respect to a Clinical Trial, the primary and secondary endpoints related to efficacy and safety that are specified in the clinical trial protocol for such Clinical Trial. |
| 1.63 | “Enforcement” has the meaning set forth in Section 11.3.3 (Settlement). |
| 1.64 | “Exclusive License” has the meaning set forth in Section 4.2.2 (Exclusive License). |
| 1.65 | “Executive Officers” means, with respect to Adaptimmune, its Chief Executive Officer, and, with respect to Galapagos, its Chief Executive Officer. |
| 1.66 | “Existing Licensed Patent Rights” means the Licensed Patent Rights existing as of the Effective Date as set out in Schedule 1.66 (Existing Licensed Patent Rights). |
| 1.68 | “FDA” means the United States Food and Drug Administration and any successor Governmental Authority having substantially the same function. |
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| similar programs or studies, in each case, where the Licensed Product is supplied without charge or at the actual manufacturing and distribution cost thereof (without any markup). |
| 1.71 | “Force Majeure” has the meaning set forth in Section 16.6 (Force Majeure). |
| 1.73 | “GAAP” means the generally accepted accounting principles in the United States, consistently applied. |
| 1.74 | “Galapagos” has the meaning set forth in the preamble. |
| 1.76 | “Galapagos Collaboration Activities” has the meaning set forth in Section 2.3.1 (Galapagos Collaboration Activities). |
| 1.77 | “Galapagos Indemnitees” has the meaning set forth in Section 15.1 (Indemnification by Adaptimmune). |
| 1.79 | “Galapagos Platform Improvement IP” means any Collaboration IP that (***). |
| 1.80 | “Galapagos Prosecuted Patent Rights” has the meaning set forth in Section 11.2.4 (Galapagos). |
| 1.81 | “Galapagos Step-In Right” has the meaning set forth in Section 11.2.3 (Adaptimmune). |
| 1.83 | “Granting Party” has the meaning set forth in Section 11.7 (Non-Controlled IP). |
| 1.85 | “Indemnified Party” has the meaning set forth in Section 15.3.1 (Notice). |
| 1.86 | “Indemnifying Party” has the meaning set forth in Section 15.3.1 (Notice). |
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| 1.87 | “Indication” means a specific disease, disorder or condition which is recognized by the applicable Regulatory Authority in a given country or jurisdiction as a disease, disorder or condition; provided, however, that, (a) with regard to oncology diseases, disorders, or conditions, an oncology disease, disorder, or condition will be considered a new Indication if it is recognized as a different type of malignancy by the applicable Regulatory Authorities; and (b) separate lines of treatment for the same disease, disorder or condition (e.g., first line, second line, combination therapy, adjuvant therapy) or patient population (e.g., treatment naïve) will not be considered separate Indications. |
| 1.88 | “Infringement” has the meaning set forth in Section 11.3.1 (Notice). |
| 1.89 | “Insolvency Event” has the meaning set forth in Section 14.2.5 (Insolvency). |
| 1.90 | “Intellectual Property” means Patent Rights, trademarks, trademark applications, and Know-How. |
| 1.91 | “IPR” has the meaning set forth in Section 1.138 (Prosecution and Maintenance). |
| 1.92 | “JPT” has the meaning set forth in Section 6.3.1 (Formation and Purpose of the JPT). |
| 1.93 | “JSC” has the meaning set forth in Section 6.2.1 (Establishment). |
| 1.94 | “Know-How” means any invention, conception, discovery, invention, creation, improvement, or modification, whether or not patentable, including processes, methods, formulas, technical information, materials (including biological and chemical materials), compositions, skills, ideas, designs, drawings, procedures, biological materials, assays, compounds, techniques, computer software and documentation, specifications, results, data (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data), know-how (including study designs and protocols), and trade secrets, in written, electronic, or any other form, including all laboratory notebooks and other written materials containing or comprising the same, as well as all intellectual property rights or other proprietary rights therein or thereto (including trade secrets) but expressly excluding Patent Rights. |
| 1.95 | “Liabilities” has the meaning set forth in Section 15.1 (Indemnification by Adaptimmune). |
| 1.96 | “Licensed IP” means the Adaptimmune CD8 Patent Rights, Adaptimmune Manufacturing Patent Rights, Adaptimmune CD8 Know-How, and Adaptimmune Manufacturing Know-How. |
| 1.97 | “Licensed Patent Rights” means the Adaptimmune CD8 Patent Rights and Adaptimmune Manufacturing Patent Rights, including the Existing Licensed Patent Rights. |
| 1.100 | “Licensed TCR Vector” means the vector encoding the Licensed TCR and referred to as (***). |
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| 1.101 | “Loan Agreement” means that certain Loan and Security Agreement between Adaptimmune Therapeutics plc (collectively with any of its affiliates that are made party to the Loan and Security Agreement) and several banks and other financial institutions or entities from time to time as party thereto and Hercules Capital, Inc. (the “Loan Agreement Agent”), dated May 14, 2024. |
| 1.102 | “Loan Agreement Agent” has the meaning set forth in Section 1.101 (Loan Agreement). |
| 1.103 | “Major European Country” means each of France, Germany, Italy, Spain, and the United Kingdom. |
| 1.105 | “Material Assumptions” means the material assumptions of the Collaboration Trial as set forth in Schedule 1.105 (Material Assumptions). |
| 1.106 | “Material Budget Increase” has the meaning set forth in Section 2.2.3 (Material Budget Increases). |
| 1.107 | “Materials Provider” has the meaning set forth in Section 4.6 (Provided Materials). |
| 1.108 | “Materials Recipient” has the meaning set forth in Section 4.6 (Provided Materials). |
| 1.109 | “Milestone Event” means any of the Development Milestone Events, the Regulatory Milestone Events, or the Sales Milestone Events, as applicable. |
| 1.110 | “Milestone Payment” means any of the Development Milestone Payments, the Regulatory Milestone Payments, or the Sales Milestone Payments, as applicable. |
In no event will any particular amount identified above be deducted more than once in calculating Net Sales (i.e., no “double counting” of deductions). All discounts, allowances, credits, rebates, and other deductions will be fairly and equitably allocated between the Licensed Product and other
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product(s) of the Seller, such that the Licensed Products do not bear a disproportionate portion of such deductions.
(***). Any sale to an independent Third Party distributor at fair market value will be deemed as end-user sale and such sales will be used for the calculation of Sales Milestone Events.
In the event a Licensed Product is sold, assigned, or transferred for consideration other than cash, the value of such non-cash consideration shall be deemed to be equal to the fair market value of the non-cash consideration as reasonably determined by Seller’s auditors from time to time. For further clarity, Net Sales of a Licensed Product will be accounted for without regard to whether such sale occurred before or after a First Commercial Sale. (***).
In the event that a Licensed Product is sold in the form of a combination incorporating the Licensed TCR with one or more other active pharmaceutical ingredients (in the same package, including as a co-formulation), (for purposes of this Section, a “Combination”), the Net Sales for such Licensed Product shall be calculated by multiplying the Net Sales for such Combination by the fraction A/(A+B), where “A” is the gross amount invoiced for such Licensed Product sold separately in a country in the same dosage as contained in the Combination, and “B” is the gross amount invoiced for such other active ingredient(s) sold separately in such country in the same dosage as contained in the Combination.
In the event that such other active pharmaceutical ingredient(s) are not sold separately in a country in the same dosage as contained in the Combination but such Licensed Product is, the Net Sales for such Licensed Product shall be calculated by multiplying the Net Sales for such Combination by the fraction A/C, where “A” is the gross amount invoiced for such Licensed Product sold separately in such country in the same dosage as contained in the Combination, and “C” is the gross amount invoiced in such country for the Combination.
In the event that such other active pharmaceutical ingredient(s) are sold separately in a country in the same dosage as contained in the Combination but such Licensed Product is not, the Net Sales for such Licensed Product shall be calculated by multiplying the Net Sales for such Combination by the fraction (C-B)/C, where “B” is the gross amount invoiced for such other active pharmaceutical ingredient(s) sold separately in such country in the same dosage as contained in the Combination, and “C” is the gross amount invoiced in cush country for the Combination.
In the event that neither such Licensed Product nor such other active pharmaceutical ingredient(s) are sold separately in a country in the same dosage as contained in the Combination, Net Sales for royalty calculations shall be based on the fair market value of the Licensed Product as contained in the Combination mutually agreed between the Parties. In the absence of such mutual agreement either Party may refer the matter to arbitration in accordance with Section 16.3 (Dispute Resolutions).
| 1.112 | “Non-Breaching Party” has the meaning set forth in Section 14.2.2 (Material Breach). |
| 1.113 | “Non-Controlled IP” has the meaning set forth in Section 11.7 (Non-Controlled IP). |
| 1.114 | “Opposition Proceeding” has the meaning set forth in Section 11.3.2 (Enforcement Actions). |
| 1.115 | “Option” has the meaning set forth in Section 3.1 (Option Grant). |
| 1.116 | “Option Exercise Date” has the meaning set forth in Section 3.2 (Option Exercise). |
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| 1.117 | “Option Exercise Fee” has the meaning set forth in Section 10.3 (Option Exercise Fee). |
| 1.118 | “Option Exercise Notice” has the meaning set forth in Section 3.2 (Option Exercise). |
| 1.119 | “Option Expiration” has the meaning set forth in Section 3.3 (Option Expiration). |
| 1.121 | “Option Term” means the period of time beginning on the Effective Date and expiring upon the earlier to occur of (a) the Option Exercise Date and (b) Option Expiration. |
| 1.122 | “Other Collaboration IP” means any Collaboration IP other than the Adaptimmune Platform Improvement IP and the Galapagos Platform Improvement IP. |
| 1.123 | “Other Collaboration Patent Right” means any Patent Right included in the Other Collaboration IP. |
| 1.124 | “Party” and “Parties” have the meaning set forth in the preamble. |
| 1.125 | “Patent Challenge” has the meaning set forth in Section 14.2.4 (Patent Challenge). |
| 1.127 | “Paying Party” has the meaning set forth in Section 10.10.2 (Tax Cooperation). |
| 1.129 | “Personal Data” has the meaning set forth in Section 13.3.6 (Data Protection). |
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| 1.134 | “Pre-Technology Transfer Activities” has the meaning set forth in Section 5.2.2 (Pre-Technology Transfer Activities). |
| 1.135 | “Pre-Technology Transfer License” has the meaning set forth in Section 4.2.1 (Pre-Technology Transfer License). |
| 1.136 | “Pre-Technology Transfer Period” means the period of time beginning upon dosing of first patient in Collaboration Trial with the Collaboration Product and expiring on the Option Exercise Date. |
| 1.138 | “Provided Materials” has the meaning set forth in Section 4.6 (Provided Materials). |
| 1.139 | “Publication” has the meaning set forth in Section 12.5 (Publication). |
| 1.140 | “Receiving Party” has the meaning set forth in Section 12.1 (Confidential Information). |
| 1.141 | “Recipient” has the meaning set forth in Section 10.10.2 (Tax Cooperation). |
| 1.143 | “Regulatory Authority” means any applicable government regulatory authority involved in granting approvals for the Exploitation of products, including the FDA and the EMA. |
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| 1.146 | “Regulatory Milestone Event” has the meaning set forth in Section 10.4.2(a) (Regulatory Milestone Events and Payments). |
| 1.147 | “Regulatory Milestone Payment” has the meaning set forth in Section 10.4.2(a) (Regulatory Milestone Events and Payments). |
| 1.148 | “Review Period” has the meaning set forth in Section 12.5 (Publication). |
| 1.149 | “Royalties” has the meaning set forth in Section 10.5.1 (Royalty Rate). |
| 1.150 | “Royalty Rate” has the meaning set forth in Section 10.5.1 (Royalty Rate). |
| 1.151 | “Royalty Report” has the meaning set forth in Section 10.5.4 (Royalty Reports; Royalty Payments). |
| 1.152 | “Royalty Term” has the meaning set forth in Section 10.5.2 (Royalty Term). |
| 1.153 | “Rules” has the meaning set forth in Section 16.3.2(a) (Rules). |
| 1.154 | “Sales Milestone Event” has the meaning set forth in Section 10.4.3(a) (Sales Milestone Events and Payments). |
| 1.155 | “Sales Milestone Payment” has the meaning set forth in Section 10.4.3(a) (Sales Milestone Events and Payments). |
| 1.156 | “Seller” has the meaning set forth in Section 1.113 (Net Sales). |
| 1.157 | “Sole Prosecuted Patent” has the meaning set forth in Section 11.2.1 (Sole IP). |
| 1.158 | “Subcontractor” means a Third Party contractor engaged by a Party to perform certain obligations or exercise certain rights of such Party under this Agreement on a fee-for-service basis. |
| 1.160 | “Tax” or “Taxes” means any form of tax or taxation, levy, duty, charge, social security charge, contribution, or withholding of whatever nature (including any related fine, penalty, surcharge or |
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| interest) imposed by, or payable to, any Governmental Authority, or any other local, state, federal or other fiscal, revenue, customs, or excise authority, body or official. |
| 1.161 | “Technology Transfer” means all activities set forth in the Technology Transfer Plan, or otherwise related thereto or in support thereof as determined in accordance with this Agreement. |
| 1.162 | “Technology Transfer Activities” has the meaning set forth in Section 5.3.1 (Technology Transfer Activities). |
| 1.163 | “Technology Transfer Deliverables” means the agreed data, materials, results, information, and other deliverables set forth in the Technology Transfer Plan, or otherwise arising in the performance of the Technology Transfer Activities. |
| 1.164 | “Technology Transfer Period” means the period of time beginning upon Option Exercise Date and expiring on the date that the last Technology Transfer Deliverable is delivered by Adaptimmune. |
| 1.165 | “Technology Transfer Plan” has the meaning set forth in Section 5.2.1 (Technology Transfer Plan). |
| 1.166 | “Term” has the meaning set forth in Section 14.1 (Term). |
| 1.167 | “Territory” means worldwide. |
| 1.168 | “Third Party” means any Person other than Galapagos, Adaptimmune, or any of their Affiliates. |
| 1.169 | “Third Party Claims” has the meaning set forth in Section 15.1 (Indemnification by Adaptimmune). |
| 1.170 | “Third Party Infringement Claim” has the meaning set forth in Section 11.4.1 (Notice). |
| 1.171 | “Tumor-Agnostic Licensed Product” means a Licensed Product that is Developed or Commercialized using a tumor-agnostic approach (i.e., to treat multiple tumors regardless of Indication). |
| 1.174 | “Working Group” has the meaning set forth in Section 6.4 (Working Groups). |
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| 2.1. | General. During the Collaboration Period, the Parties will collaborate in the performance of the Collaboration. |
| 2.2. | Collaboration Plan. |
| 2.2.3 | (***) |
| 2.3. | Collaboration Activities. |
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| Collaboration Deliverables as set forth in the Collaboration Plan or otherwise determined in accordance with this Agreement, including the preparation and delivery of the Collaboration Trial Data Package in accordance with Section 2.6.2(b) (Collaboration Trial Data Package) (collectively, the “Adaptimmune Collaboration Activities”; and together with the Galapagos Collaboration Activities, the “Collaboration Activities”). |
| 2.6. | Collaboration Records and Reports. |
| 2.6.1 | Collaboration Records. |
| 2.6.2 | Collaboration Reports. |
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| related to the progress of the Collaboration Trial to the extent such additional information is Controlled by Adaptimmune or its Affiliates. |
| 3.4. | (***) |
| 4.1. | Mutual Collaboration License Grant. Subject to the terms and conditions of this Agreement (including Section 4.5 (No Implied Licenses; Retained Rights)), during the Collaboration Period, |
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| 4.2. | License Grants to Galapagos. |
| 4.2.3 | Restrictions. (***). |
| 4.4. | Sublicensing. |
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| License) without the prior written consent of Adaptimmune, such consent not to be unreasonably withheld, conditioned or delayed. |
| 4.5. | No Implied Licenses; Retained Rights. |
| 4.5.2 | Retained Adaptimmune Product Rights. |
| (c) | Notwithstanding anything herein to the contrary in this Agreement (including the Collaboration License and Exclusive License), Adaptimmune retains the right to |
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| make the Adaptimmune Product available to patients on a compassionate use or expanded access basis for any Indication. |
| (d) | (***). |
| 5.1. | General. During the Technology Transfer Period, the Parties will collaborate in the performance of the Technology Transfer. |
| 5.2. | Pre-Technology Transfer Activities. |
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| 5.2.2 | (***). |
| 5.3. | Technology Transfer Activities. |
| 5.4. | Diligence. Each Party will perform all of its Technology Transfer Activities in accordance with the Technology Transfer Plan and otherwise in accordance with this Agreement and the Clinical Supply Agreements (if applicable), and each Party will use all reasonable efforts to perform such Technology Transfer Activities in accordance with the agreed timelines allocated for the conduct of the Technology Transfer. |
| 5.5. | Technology Transfer Costs. Unless otherwise specified in this Article 5 (Technology Transfer) (including as set forth in Section 5.3.2 (Licensed TCR Vector Following the Option Exercise Date)), each Party will perform its Technology Transfer Activities at its own cost and expense. |
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| 6.2. | Joint Steering Committee. |
| 6.2.3 | Specific Responsibilities of the JSC. The responsibilities of the JSC will be to: |
| (a) | discuss, review, and determine whether to approve any amendment to the Collaboration Plan as provided in Section 2.2.2 (Amendments to the Collaboration Plan); |
| (b) | discuss, review, and determine whether to approve any amendment to the Technology Transfer Plan; |
| (c) | discuss and determine the amount each Party will bear with respect to a Material Budget Increase; |
| (d) | share data information relating to Adaptimmune’s SURPASS family of Clinical Trials; |
| (e) | oversee the overall strategic relationship between the Parties; |
| (f) | review and discuss the Collaboration Trial Data Package; |
| (g) | review, discuss, and resolve matters of disagreement escalated to it by the JPT; and |
| (h) | perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties. |
| 6.2.4 | JSC Meetings. |
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| 6.3. | Joint Project Team. |
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| more of its JPT representatives from time to time in its sole discretion, effective upon written notice to the other Party of such change. The Parties respective Alliance Managers may also attend all JPT meetings as non-voting observers. |
| 6.3.3 | Specific Responsibilities of the JPT. The responsibilities of the JPT will be to: |
| (a) | oversee the performance of Collaboration Activities and the Technology Transfer Activities and review and discuss the progress of the Collaboration and the Technology Transfer; |
| (b) | prepare joint proposals for amendments to the Collaboration Plan to be presented to the JSC; |
| (c) | prepare joint proposals for amendments to the Technology Transfer Plan to be presented to the JSC; |
| (d) | share information relating to the Collaboration Plan and each Party’s clinical programs as relevant to the Collaboration (including for Adaptimmune, its SURPASS family of Clinical Trials); and |
| (e) | perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties. |
| 6.3.4 | JPT Meetings. |
| (a) | The JPT will meet regularly as agreed between the Parties, or otherwise on an ad-hoc basis as reasonably requested by either Party. No later than (***) Business Days prior to any regular meeting of the JPT, the Alliance Managers will jointly prepare and circulate an agenda for such meeting; provided, however, that either Party may propose additional topics to be included on such agenda, prior to such meeting so long as the other Party consents to such later additional of such agenda items. The JPT may meet in person or by means of teleconference, internet conference, videoconference, or other similar communications equipment. Each Party will bear its own travel, lodging and telecommunication expenses related to participation in and attendance at such meetings by its JPT representatives. |
| (b) | Each Party may invite non-voting observers to attend any JPT meeting; provided that any such observers who are not employees of either Party or its Affiliates may only attend with the prior written consent of the other Party, which consent will not be unreasonably withheld. All such observers will be bound by confidentiality, non-disclosure and non-use obligations similar to those contained in Article 12 (Confidentiality; Publication), or which are otherwise acceptable to both Parties. |
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| any actions proposed or decisions made by the JPT. The Parties will refrain from including any opinions or other extraneous content in such minutes. The JPT minutes will become official when approved by the JPT at the next regularly scheduled JPT meeting, it being understood that actionable items approved and directed by the JPT will commence notwithstanding the formal approval of JPT minutes. Any discrepancies or disputes with respect to the content of JPT minutes will be resolved by the Parties prior to being presented at a JPT meeting for approval. |
| 6.5. | Decision-Making. |
| 6.5.2 | Within any Working Group. If any Working Group does not reach agreement with respect to a matter within (***) Business Days after first attempting to resolve such matter, it will be elevated to the JPT, which will meet as soon as possible thereafter for discussion and resolution of the matter. |
| 6.5.3 | Within the JPT. At the JPT, each Party’s representatives will, collectively, have (***)vote in all decisions within the JPT’s purview, and the JPT will make all decisions by (***) vote; provided that in the event that the JPT does not reach agreement with respect to a matter within (***) Business Days after first attempting to resolve such matter, it will be elevated to the JSC, which will meet as soon as possible thereafter for discussion and resolution of the matter. |
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| 8.1. | Responsibility for Regulatory Approvals. |
| 8.2. | Interactions with Regulatory Authorities. |
| 8.2.2 | Galapagos Rights. Following the Option Exercise Date and subject to completion of the Technology Transfer under Section 5.3 (Technology Transfer Activities), Galapagos (or |
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| its Affiliates or other designees) will have the sole right to communicate and otherwise interact with Regulatory Authorities with respect to any Licensed Product, including with respect to preparing, obtaining and maintaining any Regulatory Approvals and other Regulatory Materials in connection therewith; provided that Adaptimmune will provide reasonable support and assistance to Galapagos as may be reasonably requested by Galapagos, in preparing, obtaining and maintaining Regulatory Approvals and other Regulatory Materials for Licensed Products. (***). |
| 8.2.3 | Safety Information Exchange. Each Party will fulfill its requirements for pharmacovigilance regulatory compliance. A mutually agreed pharmacovigilance agreement will be signed between the Parties, detailing each Party’s responsibilities. This will be done at the latest before the start of the Collaboration Trial. For the avoidance of doubt, for any pharmacovigilance matters (including in relation to safety data) the pharmacovigilance agreement shall take precedence over this Agreement. |
| 8.3. | Adaptimmune Product. For the avoidance of doubt, during the Term, Adaptimmune (or its Affiliates or other designees) will have the sole right to communicate and otherwise interact with Regulatory Authorities with respect to Adaptimmune’s Development and other Exploitation of the Adaptimmune Product. |
| 9.1. | Manufacturing and Supply of Collaboration Products. |
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| 10.1. | Upfront Payment. Within 10 Business Days following the Effective Date, Galapagos will pay Adaptimmune a non-refundable, non-creditable, one-time payment of $70,000,000. |
| 10.4. | Milestones. |
| 10.4.1 | Development Milestones. |
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(***) | (***) |
(***) | (***) |
(***) | (***) |
** (***)
| (b) | Notification of Achievement and Payment. Galapagos will notify Adaptimmune upon the first achievement of each Development Milestone Event and pay Adaptimmune the corresponding Development Milestone Payment within (***) days following such achievement by Galapagos or any of its Affiliates or Sublicensees. Each Development Milestone Payment will be payable only once on the first occurrence of the corresponding Development Milestone Event for the first Licensed Product, regardless of the number of Licensed Products that achieve such applicable Development Milestone Event. In no event will the aggregate Development Milestone Payments payable under Section 10.4.1(a) (Development Milestone Events and Payments) exceed $(***). |
| (d) | (***) |
| 10.4.2 | Regulatory Milestones. |
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| (c) | (***) |
| 10.4.3 | Sales Milestones. |
Sales Milestone Event | Milestone Payment |
(***) | (***) |
(***) | (***) |
(***) | (***) |
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| such Calendar Year, to the extent such Sales Milestone Payments have not already been paid with respect to a previous Calendar Year. |
| 10.5. | Royalties. |
Portion of Aggregate Annual Net Sales of all Licensed Products in the Territory | Royalty Rate |
(***) | (***) |
(***) | (***) |
(***) | (***) |
(***) | (***) |
| 10.5.3 | Royalty Reductions; Royalty Floor. |
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| payment under this Agreement. Upon reasonable prior notice, such records will be available during regular business hours for a period of (***) years from the end of the Calendar Year concerned for examination at Adaptimmune’s expense, and not more often than once each Calendar Year, by an independent certified public accountant selected by Adaptimmune and reasonably acceptable to Galapagos (which acceptance will not be unreasonably withheld), for the sole purpose of verifying the accuracy of the financial reports furnished by Galapagos pursuant to this Agreement. Any such auditor will not disclose Confidential Information of Galapagos, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by Galapagos or the amount of payments due under this Agreement. For clarity, the auditor will disclose the Confidential Information of Galapagos to Adaptimmune only to the extent necessary to confirm calculation of payments under this Agreement, as applicable. Adaptimmune will provide Galapagos with a copy of audit report within (***) days from its receipt of such audit report from the accountant. Any amounts shown to be owed but unpaid will be paid within (***) days from the receipt of the copy of audit report by Galapagos, plus interest (as set forth in Section 10.7 (Late Payments)) from the original due date. Any amounts shown to have been overpaid will be creditable and refunded within (***) days from the accountant’s report. Adaptimmune will bear the full cost of such audit unless such audit discloses an underpayment of the amount actually owed during the applicable Calendar Year of more than (***) of the amounts actually owed, in which case Galapagos will bear the full cost of such audit. |
| 10.8. | No Refunds. Except as expressly provided herein, all payments under this Agreement will be irrevocable, non-refundable, and non-creditable. |
| 10.10. | Taxes. |
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| 11.1. | Intellectual Property Ownership. |
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| 11.1.2 | Collaboration IP. |
| (b) | Platform Improvement IP. Adaptimmune will own all Adaptimmune Platform Improvement IP, and Galapagos will own all Galapagos Platform Improvement IP. |
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| 11.2. | Patent Prosecution. |
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| reasonable cooperation and assistance to Galapagos at Galapagos’ reasonable request and at Galapagos’ expense to transfer such ownership to Galapagos and in connection with the Prosecution and Maintenance of such transferred Adaptimmune Prosecuted Patent Rights, including making data, reports, and scientific personnel reasonably available to prepare and prosecute patent applications. In such event, however, such transferred Adaptimmune Prosecuted Patent Right will remain a Licensed Patent Right for the purposes of the definition of Valid Claim and the royalty provisions of this Agreement (subject to all other requirements set forth therein). |
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| (including the CD8 sub-unit) (each such application a “Divisional Patent Application”, and such application and all Patent Rights claiming priority thereto or issuing therefrom through the world the “Divisional Patent Rights”), as follows: |
| (a) | Prior to the Option Exercise Date, Adaptimmune will draft such Divisional Patent Application and share it with Galapagos for its comment and approval. Once Galapagos has approved such Divisional Patent Application, Adaptimmune will file the Divisional Patent Application, and on such filing the corresponding Divisional Patent Rights will constitute an Adaptimmune Prosecuted Patent Right under Section 11.2.3 (including as being subject to the Galapagos Step-In Right), save as otherwise provided in this Section 11.2.5. |
| (b) | Following the Option Exercise Date, Galapagos will, at its sole discretion and expense, have the first right (but not the obligation) to Prosecute and Maintain the Divisional Patent Rights, and the Divisional Patent Rights will constitute Galapagos Prosecuted Patent Rights (including as being subject to the Adaptimmune Step-In Right), save as otherwise provided in this Section 11.2.5 (Divisional Patent Rights). |
| 11.3. | Enforcement. |
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| 11.3.6 | Claim for Invalidity or unenforceability. To the extent that any Third Party brings a claim for the invalidity or unenforceability of any Patent Right part of the Licensed IP, the Party owning such Patent Right or if different the Party responsible for Prosecuting and Maintaining such Patent Right, shall be responsible, in its sole discretion, for defending such invalidity or unenforceability claim. The other Party shall reasonably cooperate and work with the defending Party in the defence of such claim and may appoint its own Counsel in relation to such claim at its own cost and expense. The defending Party will keep the other Party reasonably informed at all times of the progress of such claim. To the extent the claim relates to any Patent Right part of the Licensed IP and Adaptimmune chooses not to defend such claim, then each claim in the specific Patent Right that Adaptimmune declines to defend will no longer be considered a Valid Claim with respect to all Licensed Products for the purposes of this Agreement. |
| 11.4. | Third Party Infringement Claims. |
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| promptly notify the other Party of any misuse or unauthorized disclosure of the other Party’s Confidential Information. |
| 12.3.1 | was lawfully known by the Receiving Party without restriction prior to disclosure under this Agreement; |
| 12.3.2 | was lawfully disclosed to the Receiving Party by a Third Party without an obligation of confidentiality; |
| 12.3.3 | entered the public domain through means other than an unauthorized disclosure or other breach of this Agreement or the Confidentiality Agreement by the Receiving Party; or |
| 12.3.4 | was independently developed by the Receiving Party without knowledge or use of or access to Confidential Information disclosed by the Disclosing Party under this Agreement. |
Any combination of features or disclosures will not be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the rightful possession of the Receiving Party unless the combination itself and principle of operation are published or available to the general public or are otherwise in the rightful possession of the Receiving Party.
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| 12.6. | Publicity; Use of Names. |
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| 13.1. | Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that: |
| 13.1.1 | Good Standing. Each Party is duly organized, validly existing, and in good standing under the Applicable Laws of the jurisdiction of its incorporation or organization; |
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| 13.1.5 | Anti-Bribery. In entering into this Agreement, neither Party has not accepted or been offered any consideration intended to improperly influence its acceptance of this Agreement or any of the terms set out in this Agreement. |
| 13.2. | Additional Representations and Warranties of Adaptimmune. Adaptimmune hereby represents and warrants to Galapagos, as of the Effective Date, that: |
| 13.2.2 | The Existing Patent Rights are solely owned by Adaptimmune and other than the Loan Agreement are not subject to any Third Party liens or encumbrances. |
| 13.2.3 | Adaptimmune has not previously assigned, transferred, conveyed, or granted any license or other rights under Adaptimmune’s Intellectual Property that would conflict with or limit the scope of any right, option, or license granted to Galapagos hereunder. |
| 13.2.4 | (***) |
| 13.2.5 | In the development of the Licensed IP, the Licensed TCR, the Licensed TCR Vector, and the Licensed TCR Vector Manufacturing process, Adaptimmune did not misappropriate any intellectual property right or other proprietary right of any Third Party. |
| 13.3. | Covenants of Each Party. Each Party hereby covenants to the other Party beginning on the Effective Date through the remainder of the Term that: |
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| 13.3.1 | Compliance with Laws. Each Party will comply with all Applicable Laws and other legal requirements applicable to such Party in the performance of its activities under this Agreement. |
| 13.3.5 | Anti-Bribery. The Parties will not directly or indirectly, offer or pay or authorize such offer or payment of any money or other consideration to improperly influence or seek to influence any governmental official. In performing its respective obligations under this Agreement each Party will comply with all Applicable Laws relating to anti-bribery and anti-corruption. |
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| provided by the other Party solely for the purposes of this Agreement and for no other purpose. Each Party agrees to comply with the principles set out in the Applicable Laws in respect of Personal Data and will hold all Personal Data strictly confidential. Each Party will have in place appropriate technical and organizational measures to prevent any accidental or unintended processing of Personal Data provided to it by the other Party. |
| 13.4. | Additional Covenant of Adaptimmune. Adaptimmune hereby covenants to Galapagos beginning on the Effective Date through the remainder of the Term: |
| 13.4.1 | Adaptimmune will not Develop, Manufacture, Commercialize or otherwise Exploit the Adaptimmune Product other than in the exercise of the Adaptimmune Product Rights. |
| 13.4.2 | During the Collaboration Period, Adaptimmune will only use the Development Fee for the purposes of the performance of its Collaboration Activities. |
| 13.4.3 | (***)Adaptimmune will not assign, transfer, convey, or grant any license or other rights to any Third Party under the Licensed IP that would conflict with or limit the scope of any right, option, or license granted to Galapagos hereunder. |
| 14.2. | Termination. |
| 14.2.1 | For Convenience. Galapagos will have the right to terminate this Agreement in its entirety, in its discretion, upon at least 90 days’ prior written notice to Adaptimmune. |
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| finally determined that the Breaching Party committed a material breach of this Agreement or failed to cure a material breach of this Agreement, then the applicable cure period will resume and unless such alleged breach was cured during the pendency of such cure period (once resumed), this Agreement will terminate effective as of the expiration of such cure period. If, as a result of such dispute resolution proceeding, it is determined that the Breaching Party did not commit such material breach or such material breach was cured in accordance with this Section 14.2.2 (Material Breach), then no termination of this Agreement will be effective, and this Agreement will continue in full force and effect. |
| 14.2.4 | (***) |
| 14.2.6 | Full Force and Effect During Notice Period. This Agreement will remain in full force and effect until the expiration of the applicable termination notice period. |
| 14.3. | Effects of Termination. Upon any termination of this Agreement: |
| 14.3.1 | Option. If this Agreement is terminated prior to the expiration of the Option Period, then the Option will terminate. |
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| 14.3.7 | Return of assigned Patent Rights. Following termination, Adaptimmune may request the assignment back of any Patent Rights assigned to Galapagos in accordance with Section 3.4.6 and/or 11.2.3. Following such request, Galapagos will take such actions as required to formalize or otherwise perfect such assignment between the Parties and towards Third Parties (including the applicable patent offices), including in accordance with Section 16.12 (Further Assurances). |
| 15.1.1 | the breach of any obligation, representation, warranty, or covenant under this Agreement by or on behalf of Adaptimmune or any of its Affiliates; |
| 15.1.2 | the conduct of the Collaboration Trial by or on behalf of Adaptimmune or any of its Affiliates; |
| 15.1.3 | the Manufacture and supply of the Licensed TCR Vector by or on behalf of Adaptimmune; and |
| 15.1.4 | the negligence or willful misconduct of any Adaptimmune Indemnitees in the course of performing activities under this Agreement; |
except, in each case, to the extent such Liabilities arise from any Third Party Claim for which Galapagos is responsible for indemnifying Adaptimmune pursuant to Section 15.2 (Indemnification by Galapagos), as to which Liabilities each Party will indemnify the other to the extent of their respective liability.
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| 15.2.1 | the breach of any obligation, representation, warranty, or covenant under this Agreement by or on behalf of Galapagos or any of its Affiliates; |
| 15.2.3 | the Manufacture of the Collaboration Product by or on behalf of Galapagos; and |
| 15.2.4 | the negligence or willful misconduct of any Galapagos Indemnitees in the course of performing activities under this Agreement; |
except, in each case, to the extent such Liabilities arise from any Third Party Claim for which Adaptimmune is responsible for indemnifying Galapagos pursuant to Section 15.1 (Indemnification by Adaptimmune), as to which Liabilities each Party will indemnify the other to the extent of their respective liability.
| 15.3. | Indemnification Procedure. |
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| participate in all settlement conferences), but not control, at its own expense and with counsel of its choice, in the defense of any claim that has been assumed by the other Party. |
| 15.5. | Insurance. |
| 16.2. | Governing Law. This Agreement will be governed, and the respective rights of the Parties determined, according to the substantive laws of England and Wales without giving effect to any |
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| choice of law principles that would require the application of the laws of a different state. Notwithstanding the foregoing, any dispute, controversy, or claim relating to the scope, validity, enforceability, or infringement of any Intellectual Property will be submitted to a court of competent jurisdiction in the territory in which such Intellectual Property were granted or arose. |
| 16.3. | Dispute Resolution. |
| 16.3.2 | Arbitration. |
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| award is made. The written resolution and award will be delivered to the Parties as expeditiously as possible, but in no event more than 90 days after conclusion of the hearing, unless otherwise agreed by the Parties. Judgment upon such award may be entered in any competent court or application may be made to any competent court for judicial acceptance of such an award and order for enforcement. Each Party agrees that, except as permitted by Section 16.1 (Limitation of Liability), notwithstanding any provision of applicable law or of this Agreement, it will not request, and the arbitrators will have no authority to award, punitive or exemplary damages against any Party. |
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| the benefit of all rights (including all licenses and options) of such Party under this Agreement. Accordingly, in this Agreement “Galapagos” will be interpreted to mean “Galapagos or its Affiliates” and “Adaptimmune” will be interpreted to mean “Adaptimmune or its Affiliates” where necessary to give each Party’s respective Affiliates the benefit of the rights provided to the applicable Party in this Agreement; provided, however, that in any event each Party will remain responsible hereunder for all acts and omissions of its respective Affiliates and primarily responsible and liable for performance of all its obligations hereunder. |
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| for the act or failure to act of the other Party. Nothing in this Agreement, express or implied, is intended to confer on any Person other than the Parties and their Affiliates or their permitted assigns any benefit, right, or remedy. |
If to Adaptimmune:
Adaptimmune Limited
00 Xxxxxxx Xxxxxx, Xxxxxx Xxxx
Abingdon, Oxfordshire, OX14
Attention: General Counsel and COO, Adaptimmune Limited
Email: xxxxx@xxxxxxxxxxx.xxx
If to Galapagos:
2800 Mechelen
Belgium
Attention: Chief Executive Officer
With a copy (which will not constitute notice) to:
Xxxxxxxx Xx Xxxxxxxxx X00 X0
2800 Mechelen
Belgium
Attention: Legal Department
Email: (***)
and
Xxxxxxxx Xx Xxxxxxxxx X00 X0
2800 Mechelen
Belgium
Attention: Alliance Manager
Email: (***)
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[Signature Page Follows]
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IN WITNESS WHEREOF, the duly authorized representatives of the Parties hereby execute this Agreement as of the date first written above.
Galapagos NV | Adaptimmune Limited |
By: /s/ Xxxx Xxxxxxxx | By: /s/ Xxxxxx Xxxxxxxxx |
| |
Galapagos NV | |
By: /s/ Xxxx Xxxxxx | |
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Schedule 1.107
Material Assumptions
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Schedule 2.2
Collaboration Plan
ADAPTIMMUNE-GALAPAGOS Collaboration Plan
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Schedule 12.6.1
Press Release
[See next page]
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Adaptimmune Press Release
Adaptimmune and Galapagos sign clinical collaboration agreement with an option to exclusively license Adaptimmune’s TCR T-cell therapy candidate, uza-cel, in head & neck cancer and potential future solid tumor indications
| ● | Adaptimmune and Galapagos to conduct clinical proof-of-concept trial to evaluate the safety and efficacy of uza-cel (next-generation MAGE-A4 TCR T-cell therapy) produced on Galapagos’ decentralized manufacturing platform in patients with head & neck cancer |
| ● | Uza-cel has shown encouraging results in head & neck cancer with partial responses in four out of five patients to date in a Phase 1 trial using Adaptimmune’s centralized manufacturing platform |
| ● | Initial in vitro testing of uza-cel produced on Galapagos' decentralized manufacturing platform has shown encouraging data that support further clinical development |
| ● | Adaptimmune to receive initial payments of $100 million, comprising $70 million upfront and $30 million of R&D funding, option exercise fees of up to $100 million, additional development and sales milestone payments of up to a maximum of $465 million, plus tiered royalties on net sales |
| ● | Galapagos has been granted an option to exclusively license uza-cel for global development and commercialization in head & neck cancer, and potential future solid tumor cancer indications |
Adaptimmune will hold a conference call tomorrow (May 31st) at 8 a.m. EDT
(webcast link here and more details below)
Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - May 30, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), and Galapagos NV (Euronext & NASDAQ: GLPG) announced today that they have entered into a clinical collaboration agreement with an option to exclusively license Adaptimmune’s next-generation TCR T-cell therapy (uza-cel) targeting MAGE-A4 for head & neck cancer and potential future solid tumor indications, using Galapagos’ decentralized cell manufacturing platform.
Uza-cel is a next-generation clinical-stage engineered TCR T-cell therapy developed by Adaptimmune, targeting the MAGE-A4 cancer antigen expressed in various solid tumors. Uza-cel is engineered to express the CD8α co-receptor alongside the engineered TCR that targets MAGE-A4. Data indicate that co-expression of CD8α may broaden and increase the immune response against solid tumors.1
The Adaptimmune sponsored Phase 1 SURPASS trial with centrally manufactured uza-cel has shown encouraging results in head & neck cancer with an overall response rate of 80%. Initial in vitro results suggest that uza-cel, produced on Galapagos’ decentralized manufacturing platform, yields early phenotype T-cells that could improve efficacy and durability compared to uza-cel centrally manufactured on Adaptimmune’s platform.2 In addition, Galapagos’ decentralized manufacturing platform offers the potential for the delivery of fresh, fit cells with a vein-to-vein time of seven days in a patient population in which rapid access to treatment is vital.
1 Poster presentation ESMO 2021: Safety and efficacy from the SURPASS trial with ADP-A2M4CD8, a SPEAR T-cell therapy incorporating a CD8α co-receptor and an affinity optimized TCR targeting MAGE-A4, Annals of Oncology, vol. 32, suppl. 5, pp. S604-S605. Poster presentation SITC 2021: Enhancement of TCR-engineered T-cells targeting MAGE-A4 antigen by co-expression of CD8α and inhibition of AKT signaling during ex vivo T-cell expansion. SITC Annual Meeting. Nov. 10-14, 2021. Washington, DC and virtual. Xxxxx Xxxxxxx, PhD, et al.
2 Data on file
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Xxxxxx Xxxxxxxxx, Adaptimmune’s Chief Executive Officer: “Data with uza-cel from our Phase 1 SURPASS trial has demonstrated compelling early results in ovarian, bladder, and head & neck cancers. In head & neck cancer, we have seen reductions in target lesions across all five patients treated to date, and there have been four confirmed partial responses. Combining uza-cel with Galapagos’ unique decentralized manufacturing platform is a natural synergy and has the potential to deliver an even more effective TCR T-cell therapy for people with critical late-stage cancers.”
Xx. Xxxx Stoffels3, Galapagos’ Chief Executive Officer and Chairman: “We are excited to partner with Adaptimmune, a pioneer in TCR T-cell therapy, as this fully aligns with our strategic vision to advance novel cell therapies. This collaboration enables us to expand our oncology cell therapy portfolio to include treatments for solid tumors and next-generation therapies, leveraging our innovative, decentralized cell therapy manufacturing platform. For patients with head & neck cancer, an area with significant unmet medical needs, this collaboration offers the promise for faster access to a potentially transformative treatment.”
Under the terms of the agreement, Adaptimmune will receive an upfront exclusivity payment of $70 million, plus $15 million in R&D funding at signing. A further $15 million in R&D funding will follow subject to the start of dosing in the proof-of-concept trial. Adaptimmune will be responsible for the clinical proof-of-concept trial in head & neck cancer and the supply of the vector for the manufacturing of uza-cel. Galapagos will be responsible for the delivery of fresh uza-cel product for the head & neck cancer proof-of-concept trial using its innovative, decentralized cell therapy manufacturing platform.
Adaptimmune will retain the right to develop, manufacture, commercialize, and otherwise exploit uza-cel for platinum-resistant ovarian cancer (currently being developed in the SURPASS-3 trial).
Following completion of the proof-of-concept trial, Galapagos has an exclusive option to license global rights to uza-cel for a maximum of $100 million, depending on the number of indications in relation to which the option is exercised. In addition, Adaptimmune is eligible to receive development, regulatory and sales milestone payments of up $465 million, unless the agreement is terminated, and tiered royalties on net sales in the mid-single to low-double digit range.
Conference call / webcast details – 8 a.m. EDT May 31st
A live webcast and replay can be accessed at xxxxx://xxx.xxxxxxxxxxxx.xxx/00000 . Call in information is as follows: 0-000-000-0000 (US or Canada) or x0-000-000-0000. Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.
About Galapagos’ T-cell manufacturing platform
Galapagos’ decentralized, innovative T-cell manufacturing platform has the potential for the administration of fresh, fit cells within a median vein-to-vein time of seven days, greater physician control and improved patient experience. The platform consists of an end-to-end xCellit™ workflow management and monitoring software system, a decentralized, functionally closed, automated manufacturing platform for cell therapies (using Lonza’s Cocoon®) and a proprietary quality control testing and release strategy.
About Galapagos
We are a biotechnology company with operations in Europe and the US dedicated to developing transformational medicines for more years of life and quality of life. Focusing on high unmet medical
3 Throughout this press release, ‘Xx. Xxxx Xxxxxxxx’ should be read as ‘Xx. Xxxx Xxxxxxxx, acting via Xxxxxxxx IMC BV’
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needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies, and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders. For additional information, please visit xxx.xxxx.xxx or follow us on LinkedIn or X (formerly Twitter).
About Adaptimmune
Adaptimmune is a clinical-stage biopharmaceutical company focused on designing, developing, and delivering cell therapies to transform the lives of people with cancer. The Company's unique engineered T-cell receptor (TCR) platform enables the engineering of T-cells to target and destroy cancers across multiple solid tumor types.
Forward-looking statement
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Annual Report on Form 10-K filed with the Securities and Exchange Commission for the year ended 31 December, 2023, our Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.
Adaptimmune Contacts
Investor Relations
Xxxx X. Xxxxxx, Ph.D. - VP, Corporate Affairs and Investor Relations
M : x0 000 000 0000
Xxxx.Xxxxxx@xxxxxxxxxxx.xxx
Media Relations
Xxxx Xxxxx, Senior Director of Corporate Communications
M: x0 000 000 0000
Xxxx.Xxxxx@xxxxxxxxxxx.xxx
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Galapagos Press Release
Galapagos and Adaptimmune sign clinical collaboration agreement with an option to exclusively license Adaptimmune’s TCR T-cell therapy candidate, uza-cel, in head & neck cancer and potential future solid tumor indications
| ● | Uza-cel has shown encouraging results in head & neck cancer with partial responses in four out of five patients to date in a Phase 1 trial using Adaptimmune’s centralized manufacturing platform |
| ● | Initial in vitro testing of uza-cel produced on Galapagos' decentralized manufacturing platform has shown encouraging data that support further clinical development |
| ● | Adaptimmune to receive initial payments of $100 million, comprising $70 million upfront and $30 million of R&D funding, option exercise fees of up to $100 million, additional development and sales milestone payments of up to a maximum of $465 million, plus tiered royalties on net sales |
| ● | Galapagos has been granted an option to exclusively license uza-cel for global development and commercialization in head & neck cancer, and potential future solid tumor cancer indications |
Mechelen, Belgium and Philadelphia, PA, U.S. and Oxford, UK; 30 May 22:01 CET; regulated information – inside information – Galapagos NV (Euronext & NASDAQ: GLPG) and Adaptimmune Therapeutics plc (Nasdaq: ADAP) announced today that they have entered into a clinical collaboration agreement with an option to exclusively license Adaptimmune’s next-generation TCR T-cell therapy (uza-cel) targeting MAGE-A4 for head & neck cancer and potential future solid tumor indications, using Galapagos’ decentralized cell manufacturing platform.
Uza-cel is a next-generation clinical-stage engineered TCR T-cell therapy developed by Adaptimmune, targeting the MAGE-A4 cancer antigen expressed in various solid tumors. Uza-cel is engineered to express the CD8α co-receptor alongside the engineered TCR that targets MAGE-A4. Data indicate that co-expression of CD8α may broaden and increase the immune response against solid tumors.4
The Adaptimmune sponsored Phase 1 SURPASS trial with centrally manufactured uza-cel has shown encouraging results in head & neck cancer with an overall response rate of 80%. Initial in vitro results suggest that uza-cel, produced on Galapagos’ decentralized manufacturing platform, yields early phenotype T-cells that could improve efficacy and durability compared to uza-cel centrally manufactured on Adaptimmune’s platform.5 In addition, Galapagos’ decentralized manufacturing platform offers the potential for the delivery of fresh, fit cells with a vein-to-vein time of seven days in a patient population in which rapid access to treatment is vital.
4 Poster presentation ESMO 2021: Safety and efficacy from the SURPASS trial with ADP-A2M4CD8, a SPEAR T-cell therapy incorporating a CD8α co-receptor and an affinity optimized TCR targeting MAGE-A4, Annals of Oncology, vol. 32, suppl. 5, pp. S604-S605. Poster presentation SITC 2021: Enhancement of TCR-engineered T-cells targeting MAGE-A4 antigen by co-expression of CD8α and inhibition of AKT signaling during ex vivo T-cell expansion. SITC Annual Meeting. Nov. 10-14, 2021. Washington, DC and virtual. Xxxxx Xxxxxxx, PhD, et al.
5 Data on file
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Xx. Xxxx Stoffels6, Galapagos’ Chief Executive Officer and Chairman: “We are excited to partner with Adaptimmune, a pioneer in TCR T-cell therapy, as this fully aligns with our strategic vision to advance novel cell therapies. This collaboration enables us to expand our oncology cell therapy portfolio to include treatments for solid tumors and next-generation therapies, leveraging our innovative, decentralized cell therapy manufacturing platform. For patients with head & neck cancer, an area with significant unmet medical needs, this collaboration offers the promise for faster access to a potentially transformative treatment.”
Xxxxxx Xxxxxxxxx, Adaptimmune’s Chief Executive Officer: “Data with uza-cel from our Phase 1 SURPASS trial has demonstrated compelling early results in ovarian, bladder, and head & neck cancers. In head & neck cancer, we have seen reductions in target lesions across all five patients treated to date, and there have been four confirmed partial responses. Combining uza-cel with Galapagos’ unique decentralized manufacturing platform is a natural synergy and has the potential to deliver an even more effective TCR T-cell therapy for people with critical late-stage cancers.”
Under the terms of the agreement, Adaptimmune will receive an upfront exclusivity payment of $70 million, plus $15 million in R&D funding at signing. A further $15 million in R&D funding will follow subject to the start of dosing in the proof-of-concept trial. Adaptimmune will be responsible for the clinical proof-of-concept trial in head & neck cancer and the supply of the vector for the manufacturing of uza-cel. Galapagos will be responsible for the delivery of fresh uza-cel product for the head & neck cancer proof-of-concept trial using its innovative, decentralized cell therapy manufacturing platform.
Adaptimmune will retain the right to develop, manufacture, commercialize, and otherwise exploit uza-cel for platinum-resistant ovarian cancer (currently being developed in the SURPASS-3 trial).
Following completion of the proof-of-concept trial, Galapagos has an exclusive option to license global rights to uza-cel for a maximum of $100 million, depending on the number of indications in relation to which the option is exercised. In addition, Adaptimmune is eligible to receive development, regulatory and sales milestone payments of up $465 million, unless the agreement is terminated, and tiered royalties on net sales in the mid-single to low-double digit range.
About Galapagos’ T-cell manufacturing platform
Galapagos’ decentralized, innovative T-cell manufacturing platform has the potential for the administration of fresh, fit cells within a median vein-to-vein time of seven days, greater physician control and improved patient experience. The platform consists of an end-to-end xCellit™ workflow management and monitoring software system, a decentralized, functionally closed, automated manufacturing platform for cell therapies (using Lonza’s Cocoon®) and a proprietary quality control testing and release strategy.
About Galapagos
We are a biotechnology company with operations in Europe and the US dedicated to developing transformational medicines for more years of life and quality of life. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies, and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders. For additional information, please visit xxx.xxxx.xxx or follow us on LinkedIn or X
6 Throughout this press release, ‘Xx. Xxxx Xxxxxxxx’ should be read as ‘Xx. Xxxx Xxxxxxxx, acting via Xxxxxxxx IMC BV’
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(formerly Twitter).
About Adaptimmune
Adaptimmune is a clinical-stage biopharmaceutical company focused on designing, developing, and delivering cell therapies to transform the lives of people with cancer. The Company's unique engineered T-cell receptor (TCR) platform enables the engineering of T-cells to target and destroy cancers across multiple solid tumor types.
For further information, please contact:
Media inquiries: Xxxxxxxx Xxxxxx + 44 7444 000000 xxxxx@xxxx.xxx | Investor inquiries: xx@xxxx.xxx x00 000 00 00 00 |
This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).
Forward-looking statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements are often, but are not always, made through the use of words or phrases such as “anticipate,” “expect,” “plan,” “estimate,” “will,” “continue,” “aim,” “intend,” “future,” “potential,” “could,” “indicate,” “forward,” as well as similar expressions. Forward-looking statements contained in this release include, but are not limited to, statements regarding Galapagos’ collaboration with Adaptimmune, including timing for the proof-of concept trial and payments under the collaboration agreement, including milestone and royalty payments, the potential benefits of Adaptimmune’s TCR-T therapy, uza-cel, and the potential benefits of Galapagos’ decentralized T-cell manufacturing platform. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause Galapagos’ actual results to be materially different from those expressed or implied by such forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the risk that Galapagos’ expectations regarding the collaboration with Adaptimmune, including the potential benefits of such collaboration may be incorrect, the inherent uncertainties associated with competitive developments, clinical trials and product development activities and regulatory approval requirements, Galapagos' reliance on collaborations with third parties (including its collaboration partners Adaptimmune and Lonza), as well as those risks and uncertainties identified in Galapagos’ Annual Report on Form 20-F for the year ended 31 December 2023 filed with the U.S. Securities and Exchange Commission (SEC) and its subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management’s current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations, unless required by law or regulation.
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