Exhibit 10.1
***Text Omitted and Filed Separately with the Securities and Exchange Commission.
Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406
(1) IMMUNOCORE LIMITED
and
(2) ADAPTIMMUNE LIMITED
ASSIGNMENT AND EXCLUSIVE LICENCE
Manches LLP
9400 Garsington Road
Oxford Business Park
Oxford
OX4 2HN
Tel: 01865 722106
Fax: 01865 201012
www.manches.com
THIS AGREEMENT is made BETWEEN:
(1) IMMUNOCORE LIMITED (company number 6456207) whose registered office address is AT 57c Milton Park, Abingdon, Oxfordshire, OX14 4RX (the Immunocore); and
(2) ADAPTIMMUNE LIMITED (company number 6456741) whose registered office address is 9400 Garsington Road, Oxford Business Park, Oxford, OX4 2HN (the Adaptimmune).
BACKGROUND
A. Immunocore is a company engaged in identifying modifying, developing and commercialising products containing soluble T-Cell Receptors for use in certain applications.
B. Adaptimmune is a company engaged in identifying, modifying, developing and commercialising products containing cells that are transfected within genes encoding T-Cell Receptors for use in certain applications.
C. The Parties previously entered into an Amended and Restated Licence Agreement (2011 Agreement), which amended and restated the terms of an original licence agreement dated 1 July 2008 between Medigene Limited and Adaptimmune (2008 Agreement). This 2008 Agreement was novated to Immunocore on 1 October 2008.
D. The Parties now wish to rationalise the ownership of Intellectual Property Rights under the Prior Agreements and the licensing of such Intellectual Property Rights between the Parties.
OPERATIVE PROVISIONS
Adaptimmune Licensed Product |
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means (i) any product that contains cells that are transfected with genes encoding TCRs including any product containing cells that may also be transfected with one or more additional other molecules as well (whether transfected at the same time or by the same means as the TCRs or not); and (ii) any process, service or method including such a product and where:
(a) such product is covered by any claim of the Licensed Patents or which is generated or derived using any of the Know-How or Results; or
(b) such service, process or method is covered by a claim of any of the Licensed Patents or which requires the use of any Know-How or Results;
For the avoidance of doubt Adaptimmune Licensed Product shall not include any product, service, |
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process or method comprising or containing Soluble TCRs. |
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Affiliate |
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means, in relation to any entity, any company or legal entity in any country which Controls, is Controlled by or shares common Control with that entity. The Parties shall not be Affiliates for the purposes of this Agreement; |
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Authorised Parties |
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means Affiliates, contractors, employees, licensees (and prospective licensees), sub-licensees (and prospective sub-licensees) and potential acquirers; |
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Confidential Information |
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means (a) in relation to each PParty, all technical, financial and commercial information disclosed by that Party to the other Party in the course of or in anticipation of this Agreement, together with the terms of this Agreement; (b) all Know-How; (c) all Results. |
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Control |
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means:
(a) ownership of more than 50% of the voting share capital of the relevant entity; or
(b) the ability to direct the casting of more than 50% of the votes, exercisable at a general meeting of the relevant entity on all, or substantially all, matters; |
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Core Patent |
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means a patent or patent application designated as Core in Schedule 1; |
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Divisional |
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means any divisional patent application or continuation-in-part application claiming any of the same priority as a Full Application, Later Application, Granted Patent or Core Patent. |
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Effective Date |
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means the date of last signature to this Agreement; |
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Full Application |
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shall have the meaning given in Schedule 3; |
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Granted Patent |
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means a patent or patent application designated as Granted in Schedule 1; |
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Immunocore Licensed Product |
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means (i) any product that contains Soluble TCRs; and (ii) any process, service or method including such a product and where:
(a) such product is covered by any claim of the Licensed Patents or which is generated or derived using any of the Know-How or Results; or
(b) such service, process or method is covered by a claim of any of the Licensed Patents or which requires the use of any Know-How or Results;
For the avoidance of doubt Immunocore Licensed |
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Product shall not include any product, service process or method containing or comprising cells that are transfected with genes encoding TCRs. |
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Intellectual Property Rights |
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means patents, rights to inventions, copyright and related rights, trade marks, trade names and domain names, rights in designs, rights in computer software, database rights, rights in confidential information (including know-how as summarised in schedule 2) and any other intellectual property rights, in each case whether registered or unregistered and including all applications (or rights to apply) for, and renewals or extensions of, such rights and all similar or equivalent rights or forms of protection which subsist or will subsist now or in the future in any part of the world; |
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Know-How |
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means all confidential information (excluding the Licensed Patents) created by either Party and relating to t-cell receptors, modifications to t-cell receptors, processes for the production of products comprising t-cell receptors, products comprising t-cell receptors, whether patentable or not as at the Effective Date. Know-How shall include all know-how summarised in Schedule 2; |
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Later Application |
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shall have the meaning given in Schedule 3; |
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Licensed Patents |
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means:
(a) the patents or patent applications listed in Schedule 1;
(b) any patents granted from the patent applications listed in Schedule 1;
(c) any patents or patent applications filed in accordance with Clause 4.3 and any patents granting from such patent applications;
(d) any corresponding patents and patent applications which are based on or derive priority from or common priority with the patent applications in (a) or (b) or (c); and
(d) any continuation, continuation-in-part, division, reissue, renewal or extension of any of the patents and patent applications in (a) (d). |
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Licensed Product |
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means an Adaptimmune Licensed Product and/or an Immunocore Licensed Product. |
Market |
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means, in relation to a Licensed Product, offering to sell, lease, license or otherwise commercially exploit the Licensed Product or the sale, lease, licence, export or import, distribution, marketing or other commercial exploitation of the Licensed Product; |
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Materials |
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means the materials provided by one Party to the other Party for the performance of the Project including all constructs, libraries, derivatives, portions, improvements or components of them or obtained from them or as a result of their use but excluding Results; |
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NCI Patent |
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means (i) patent application PCT/US2007/79487; and (ii) any corresponding patents and patent applications which are based on or derive priority from or common priority with PCT/US2007/79487; and (iii) any continuation, continuation-in-part, division, reissue, renewal or extension of any of the patents and patent applications in (i) and (ii). |
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Prior Agreements |
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means the 2011 Agreement and the 2008 Agreement. |
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Project |
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means any project agreed between the Parties in relation to the development, modification, creation, adaptation, mutation or other work in relation to any TCR and as set out in a Project Schedule signed by both Parties. |
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Project Schedule |
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Shall have the meaning set out in Clause 6.1. |
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Required Countries |
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means European Union, United States of America and Canada. |
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Results |
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means all Intellectual Property Rights (excluding Licensed Patents and any Divisional filed in accordance with Clauses 4.4 and 4.5) generated or created by either Party in the performance of any Project. |
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Soluble TCRs |
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TCRs in any form (whether alone or combined with other compounds or molecules) and which when administered or supplied are not comprised within or attached to (including via transfection) any cell. |
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SUSAR |
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means a suspected, unexpected, serious adverse reaction, in relation to which notification to a competent authority is required.. |
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TCR |
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means T-cell receptor |
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Territory |
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means worldwide. |
EXECUTED AS A DEED by the authorised representatives of the Parties on the date set out above.
EXECUTED as a deed for and on behalf of |
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EXECUTED as a deed for and on behalf of |
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Name: James Noble |
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Name: James Noble |
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Position: CEO, Chairman |
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Position: CEO, Chairman |
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Signature: /s/ James Noble |
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Signature: /s/ James Noble |
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In the presence of: |
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In the presence of: |
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Name of witness: Tracey Johnson |
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Name of witness: Tracey Johnson |
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Signature of witness:
/s/ Tracey Johnson |
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Signature of witness:
/s/ Tracey Johnson |
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Address and occupation of witness:
Executive Assistant |
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Address and occupation of witness:
Executive Assistant |
SCHEDULE 1 LICENSED PATENTS
Status column is included for information only and is as at Effective Date.
Case Ref. |
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Official No. |
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Title |
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Case Status |
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Designation |
Case 14 monoclonal TCRs (P32566 / 44172.00.2008) | ||||||||||||
Case14-WO |
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WO 2003/020763 |
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Soluble T cell receptor |
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International phase complete |
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Core |
Case14-AU |
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2002321581 |
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Soluble T cell receptor |
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Granted/Registered |
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Core |
Case14-CA |
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2457652 |
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Soluble T cell receptor |
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Granted/Registered |
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Core |
Case14-CN |
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02819279.6 |
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Soluble T cell receptor |
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Granted/Registered |
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Core |
Case14-EA |
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006601 |
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Soluble T cell receptor |
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Granted/Registered |
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Core |
Case14-EP |
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1421115 |
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Soluble T cell receptor |
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EP Granted (AT, BE, CH, CZ, DE, DK, EE, ES, FI, FR, GB, GR, IE, IT, NL, PT, SE, TR) |
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Core |
Case14-HK |
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1066018 |
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Soluble T cell receptor |
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Granted/Registered |
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Core |
Case14-M |
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160359 |
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Soluble T cell receptor |
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Granted/Registered |
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Core |
Case14-IN |
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212621 |
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Soluble T cell receptor |
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Granted/Registered |
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Core |
Case14-JP |
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4317940 |
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Soluble T cell receptor |
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Granted/Registered |
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Core |
Case14-KR |
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10-0945977 |
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Soluble T cell receptor |
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Granted/Registered |
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Core |
Case14-MX |
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246738 |
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Soluble T cell receptor |
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Granted/Registered |
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Core |
Case14-NO |
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331877 |
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Soluble T cell receptor |
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Granted/Registered |
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Core |
Case14-NZ |
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531208 |
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Soluble T cell receptor |
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Granted/Registered |
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Core |
Case14-PL |
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208712 |
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Soluble T cell receptor |
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Granted/Registered |
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Core |
Case14-SG |
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102850 |
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Soluble T cell receptor |
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Granted/Registered |
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Core |
Case14-US |
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7329731 |
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Soluble T cell receptor |
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Granted/Registered |
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Core |
Case14-US1 |
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7763718 |
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Soluble T cell receptor |
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Granted/Registered |
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Core |
Case14-ZA |
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2004/1197 |
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Soluble T cell receptor |
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Granted/Registered |
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Core |
Case 18 scTCR (P53462 / 44172.00.2012) | ||||||||||||
Case18-WO |
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WO2004/033685 |
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Single chain recombinant T cell receptors |
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International phase complete |
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Core |
Case18-AU |
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2003271904
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Single chain recombinant T cell receptors |
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Granted/Registered |
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Core |
Case18-CA |
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2501870
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Single chain recombinant T cell receptors |
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Granted/Registered |
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Core |
Case18-CN |
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200380101143.1
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Single chain recombinant T cell receptors |
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Granted/Registered |
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Core |
Case18-EP |
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03753742.0
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Single chain recombinant T cell receptors |
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Under Examination |
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Core |
Case18-JP |
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4436319
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Single chain recombinant T cell receptors |
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Granted/Registered |
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Core |
Case18-IL |
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167652
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Single chain recombinant T cell receptors |
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Granted/Registered |
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Core |
Case18-IN |
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227369
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Single chain recombinant T cell receptors |
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Granted/Registered |
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Core |
Case18-NO |
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2005/2198
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Single chain recombinant T cell receptors |
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Under Examination |
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Core |
Case18-NZ |
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539225
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Single chain recombinant T cell receptors |
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Granted/Registered |
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Core |
Case18-RU |
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2355703
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Single chain recombinant T cell receptors |
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Granted/Registered |
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Core |
Case18-US |
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7569664
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Single chain recombinant T cell receptors |
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Granted/Registered |
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Core |
Case18-ZA |
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2005/02927 |
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Single chain recombinant T cell receptors |
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Granted/Registered |
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Core |
Case 19 phage display (P53469 / 44172.00.2009) | ||||||||||||
Case19-WO |
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WO2004/044004 |
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T cell receptor display |
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International phase complete |
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Core |
Case19-AU |
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2003276403 |
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T cell receptor display |
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Granted/Registered |
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Core |
Case19-AU1 |
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2010202953 |
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T cell receptor display |
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Granted/Registered |
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Core |
Case19-CA |
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2505558 |
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T cell receptor |
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Under Examination |
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Core |
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display |
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Case19-CA1 |
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TBC |
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T cell receptor display |
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Under Examination |
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Core |
Case19-CN |
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ZL200380102928.0 |
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T cell receptor display |
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Granted/Registered |
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Core |
Case19-CN1 |
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CN101935636A |
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T cell receptor display |
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Abandoned |
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Core |
Case19-EP |
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1558643 |
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T cell receptor display |
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EP Granted (AT, BE, CH, CZ, DE, DK, ES, FI, FR, GB, GR, IE, IT, NL, PT, SE, TR) |
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Core |
Case19-EP1 |
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09001469.7 |
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T cell receptor display |
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Under Examination |
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Core |
Case19-IL |
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167745 |
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T cell receptor display |
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Granted/Registered |
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Core |
Case19-IN |
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232673 |
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T cell receptor display |
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Granted/Registered |
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Core |
Case19-JP |
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4975324 |
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T cell receptor display |
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Granted/Registered |
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Core |
Case19-NO |
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20052743 |
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T cell receptor display |
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Granted/Registered |
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Core |
Case19-NZ |
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539226 |
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T cell receptor display |
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Granted/Registered |
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Core |
Case19-NZ1 |
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570811 |
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T cell receptor display |
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Granted/Registered |
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Core |
Case19-RU |
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2346004 |
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T cell receptor display |
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Granted/Registered |
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Core |
Case19-US1 |
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US 2010-0113300 A1 |
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T cell receptor display |
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Under Examination |
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Core |
Case19-ZA |
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2005/03336 |
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T cell receptor display |
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Granted/Registered |
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Core |
Case 30 CD1 binding mTCRs (P53507 / 44172.00.2013) | ||||||||||||
Case30-WO |
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WO2004/074322 |
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Modified T cell Receptor |
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International phase complete |
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Full Application |
Case30-AU |
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2003254443 |
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Modified T cell Receptor |
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Granted/Registered |
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Full Application |
Case30-CA |
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2516702 |
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Modified T cell Receptor |
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Granted/Registered |
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Full Application |
Case30-CN |
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ZL 03826014.X |
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Modified T cell Receptor |
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Granted/Registered |
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Full Application |
Case30-EP |
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1594896 |
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Modified T cell Receptor |
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Granted/Registered (DE, FR, GB) |
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Full Application |
Case30-JP |
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4478034 |
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Modified T cell Receptor |
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Granted/Registered |
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Full Application |
Case30-NZ |
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541596 |
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Modified T cell Receptor |
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Granted/Registered |
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Full Application |
Case30-US |
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7666604 |
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Modified T cell Receptor |
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Granted/Registered |
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Full Application |
Case30-ZA |
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2005/06516 |
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Modified T cell Receptor |
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Granted/Registered |
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Full Application |
Case 53 CDR2 (P53600 / 44172.00.2010) | ||||||||||||
Case53-WO |
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WO2005/114215 |
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Method of improving T cell receptors |
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International phase complete |
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Core |
Case53-AU |
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2005246073 |
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Method of improving T |
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Granted/Registered |
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Core |
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cell receptors |
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Case53-CA |
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2567349 |
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Method of improving T cell receptors |
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Granted/Registered |
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Core |
Case53-CN |
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200580015878.1 |
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Method of improving T cell receptors |
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Granted/Registered |
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Core |
Case53-EP |
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1756278 |
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Method of improving T cell receptors |
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EP Granted (CH, DE, FR, GB, IE) |
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Core |
Case53-HK |
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1105995 |
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Method of improving T cell receptors |
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Granted/Registered |
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Core |
Case53-JP |
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4972549 |
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Method of improving T cell receptors |
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Granted/Registered |
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Core |
Case53-NZ |
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550815 |
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Method of improving T cell receptors |
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Granted/Registered |
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Core |
Case53-US |
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7608410 |
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Method of improving T cell receptors |
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Granted/Registered |
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Core |
Case53-ZA |
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2006/09462 |
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Method of improving T cell receptors |
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Granted/Registered |
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Core |
Case 58 mTCR adoptive therapy (P53612 / 44172.00.2003) | ||||||||||||
Case58-WO |
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WO2006/000830 |
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Cells expressing a modified T cell receptor |
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International phase complete |
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Full Application |
Case58-EP |
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1791865 |
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Cells expressing a modified T cell receptor |
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EP Granted (AT, BE, CH, DE, DK, ES, FR, GB, IE, IT, LU, NL, SE) |
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Full Application |
Case58-JP |
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2007-518692 |
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Cells expressing a modified T cell receptor |
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Under Examination |
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Full Application |
Case58-US |
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8361794 |
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Cells expressing a modified T cell receptor |
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Granted/Registered |
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Full Application |
Case58-US1 |
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13/716817 |
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Cells expressing a modified T cell receptor |
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Under Examination |
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Full Application |
Case 74 HIV gag (P53593 / 44172.00.2007) | ||||||||||||
Case74-WO |
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WO2006/103429 |
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High affinity HIV T cell receptors |
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International phase complete |
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Full Application |
Case74-AU |
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2006228308 |
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High affinity HIV T cell receptors |
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Granted/Registered |
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Full Application |
Case74-AU1 |
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2012211503 |
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High affinity HIV T cell receptors |
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Under Examination |
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Full Application |
Case74-AU2 |
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TBC |
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High affinity HIV T cell receptors |
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Under Examination |
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Full Application |
Case74-CA |
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2602463 |
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High affinity HIV T cell receptors |
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Under Examination |
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Full Application |
Case74-CN |
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200680011470.1 |
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High affinity HIV T cell receptors |
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Under Examination |
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Full Application |
Case74-CN1 |
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201210563915.4 |
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High affinity HIV T cell receptors |
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Under Examination |
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Full Application |
Case74-EP |
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06726555.3 |
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High affinity HIV T cell receptors |
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Under Appeal |
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Full Application |
Case74-EP1 |
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10008612.3 |
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High affinity HIV T cell receptors |
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Under Examination |
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Full Application |
Case74-EP2 |
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10014971.5 |
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High affinity HIV T cell receptors |
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Under Examination |
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Full Application |
Case74-JP |
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2008-503585 |
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High affinity HIV T cell receptors |
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Under Examination |
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Full Application |
Case74-JP1 |
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2012-49174 |
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High affinity HIV T cell receptors |
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Under Examination |
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Full Application |
Case74-NZ |
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561338 |
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High affinity HIV T cell receptors |
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Granted/Registered |
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Full Application |
Case74-NZ1 |
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584523 |
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High affinity HIV T cell receptors |
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Granted/Registered |
|
|
Full Application |
Case74-US |
|
|
8378074 |
|
|
High affinity HIV T cell receptors |
|
|
Granted/Registered |
|
|
Full Application |
Case74-US1 |
|
|
11/733545 |
|
|
High affinity HIV T cell receptors |
|
|
Under Examination |
|
|
Full Application |
Case74-ZA |
|
|
2007/08037 |
|
|
High affinity HIV T cell receptors |
|
|
Granted/Registered |
|
|
Full Application |
Case 77 Melan A (P53578 / 44172.00.2006) | ||||||||||||
Case77-WO |
|
|
WO2006/129085 |
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|
High affinity Melan-A T cell receptors |
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|
International phase complete |
|
|
Full Application |
Case77-AU |
|
|
2006253941 |
|
|
High affinity Melan-A T cell receptors |
|
|
Granted/Registered |
|
|
Full Application |
Case77-CA |
|
|
2610786 |
|
|
High affinity Melan-A T cell receptors |
|
|
Under Examination |
|
|
Full Application |
Case77-CN |
|
|
ZL200680019562.4 |
|
|
High affinity Melan-A T cell receptors |
|
|
Granted/Registered |
|
|
Full Application |
Case77-EP |
|
|
06744042.0 |
|
|
High affinity |
|
|
Under Examination |
|
|
Full |
|
|
|
|
|
|
Melan-A T cell receptors |
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|
|
|
Application |
Case77-JP |
|
|
2008-514187 |
|
|
High affinity Melan-A T cell receptors |
|
|
Abandoned |
|
|
Full Application |
Case77-US |
|
|
8217144 |
|
|
High affinity Melan-A T cell receptors |
|
|
Granted/Registered |
|
|
Full Application |
Case 82 VYG Telomerase (P53589 / 44172.00.2014) | ||||||||||||
Case82-WO |
|
|
WO2006/125962 |
|
|
T cells receptors which specifically bind to VYGFVRACL-HLA-24 |
|
|
International phase complete |
|
|
Full Application |
Case82-CN |
|
|
200680018255.4 |
|
|
T cells receptors which specifically bind to VYGFVRACL-HLA-24 |
|
|
Granted/Registered |
|
|
Full Application |
Case82-EP |
|
|
1885754 |
|
|
T cells receptors which specifically bind to VYGFVRACL-HLA-24 |
|
|
Granted/Registered (DE, ES, FR, GB, IT) |
|
|
Full Application |
Case82-JP |
|
|
5149789 |
|
|
T cells receptors which specifically bind to VYGFVRACL-HLA-24 |
|
|
Granted/Registered |
|
|
Full Application |
Case82-US |
|
|
8017730 |
|
|
T cells receptors which specifically bind to VYGFVRACL-HLA-24 |
|
|
Granted/Registered |
|
|
Full Application |
Case 91 kinetic window (P53583 / 44172.00.2004) | ||||||||||||
Case91-WO |
|
|
WO2008/038002 |
|
|
T Cell Therapies |
|
|
International phase complete |
|
|
Full Application |
Case91-EP |
|
|
07823938.1 |
|
|
T Cell Therapies |
|
|
Under Examination |
|
|
Full Application |
Case91-US |
|
|
12/443078 |
|
|
T Cell Therapies |
|
|
Under Examination |
|
|
Full Application |
Case 120 alanine scanning (P56242) | ||||||||||||
Case120-GB |
|
|
1223172.6 |
|
|
*** |
|
|
Application filed |
|
|
Core |
Case 121 Improved TCR Isolation Method (P56602 / 44172.00.2018) | ||||||||||||
Case121- |
|
|
1304687.5 |
|
|
*** |
|
|
Application Filed |
|
|
Core |
*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
GB |
|
|
|
|
|
|
|
|
|
|
|
|
Case121-US |
|
|
61/788,491 |
|
|
*** |
|
|
Provisional application filed |
|
|
Core |
*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
SCHEDULE 2
know-how
know-how shall include the following:
1. |
confidential information relating to the selection of target peptide-MHCs; |
|
|
2. |
T-cell lines and clones; |
|
|
3. |
Genes encoding T-cell receptors and vectors encoding such genes; |
|
|
4. |
confidential information relating to T-cell receptor design, engineering and production by any method; |
|
|
5. |
confidential information relating to production of soluble T-cell receptors; |
|
|
6. |
confidential information relating to production of soluble T-cell receptors linked to other reagents; |
|
|
7. |
confidential information relating to the determination of the affinity and kinetic characteristics of T-cell receptors/pMHC interactions; |
|
|
8. |
confidential information relating to the transfection of cells with genes encoding T-cell receptors including transfected cell lines; |
|
|
9. |
confidential information relating to phage display-based generation and selection of high affinity T-cell receptors; |
|
|
10. |
confidential information relating to the design, conduct and interpretation of T cell assays with soluble T-cell receptors or adoptively transferred T-cell receptors in cells; |
SCHEDULE 3
PATENT PROCESS
Where any Notification is received under Clause 4.2 of this Agreement, any resulting patent or patent application will be filed, prosecuted and maintained in accordance with the following process. Performance of and decisions taken in relation to any notified invention, Provisional Application, Full Application or Later Application may be recorded and approved in accordance with the template set out in Schedule 5.
In relation to Licensed Patents filed as at the Effective Date, Schedule 3 shall apply to such patents and patent applications in accordance with the designation set out in Schedule 1.
1. Any Notification shall specify a summary of the invention in relation to which the patent application is proposed to be filed.
2. The Parties may agree not to file a patent application in relation to any Notification. If no patent application is filed then the relevant invention shall be maintained as confidential in accordance with Clause 7 of this Agreement.
3. Where the Parties do not agree to maintain the notified invention as confidential, then Immunocore shall be responsible for the filing of the patent application (Provisional Application). The Provisional Application shall be filed in the joint names of both Parties.
4. The Parties will use all reasonable endeavours to agree the contents of the Provisional Application within 3 months of original notification under paragraph 1 above (or where any Provisional Application is being filed or re-filed in accordance with paragraph 5 below, within a period of twelve (12) months from filing date of original Provisional Application). Any disagreement as to scope and content of Provisional Application shall be resolved in favour of Adaptimmune. The Provisional Application shall be filed as a minimum with the UK Intellectual Property Office.
5. Within a period of twelve (12) months from filing date of Provisional Application the Parties shall agree whether to (a) file a full patent application or applications corresponding to the Provisional Application; or (b) add additional matter to any Provisional Application; or (c) withdraw any Provisional Application and maintain the contents and invention as confidential; or (d) withdraw any Provisional Application and re-file the same application or a variation of such application. Where the Provisional Application or a variation of such application is re-filed the provisions of this Schedule 3 shall apply as if such re-filed application was the first Provisional Application. The content of any additional matter added to any Provisional Application shall be agreed by both Parties. Any disagreement as to whether or not the Provisional Application is withdrawn, a full patent application filed or the Provisional Application re-filed or the content of any Provisional Application shall be resolved in favour of Adaptimmune.
6. Where the Parties agree to file a full patent application or applications corresponding to any Provisional Application, Immunocore shall file a full patent application or applications corresponding to the Provisional Application (Full Application). Both Parties will use reasonable endeavours to agree on the contents of the Full Application. Any disagreement as to scope and content of Full Application will be resolved in favour of Adaptimmune if the Full
Application contains Adaptimmune-only mutations. If the content of the Full Application contains both Immunocore and Adaptimmune mutations, any disagreement as to scope and content of the Full Application shall be resolved in favour of Immunocore save that Immunocore shall be obliged to include all mutations or combinations of mutations in the Full Application as are requested to be included by Adaptimmune. For the avoidance of doubt, the Full Application may be identical in content to the Provisional Application.
7. The Full Application shall be filed as an application in accordance with the Patent Co-operation Treaty. The Full Application shall be filed in the joint names of both Parties. The Parties shall agree which filing strategy is appropriate in each case. In the event of any failure to agree, an application in accordance with the Patent Co-operation Treaty at the UK Intellectual Property Office shall be filed as far as possible specifying all Patent Co-operation Treaty countries.
8. Immunocore shall be responsible for the filing, prosecution and maintenance of the Full Application in accordance with the following:
a. use best endeavours to file, obtain and maintain valid patents pursuant to the Full Application so as to secure the broadest monopoly reasonably available in the countries chosen by Immunocore after consultation with Adaptimmune. Such countries shall include as a minimum the Required Countries unless otherwise agreed with Adaptimmune in writing;
b. ensure that Adaptimmune is kept fully informed, and consult with Adaptimmune in relation to all matters relating to the filing, prosecution and maintenance of the Full Application; and
c. supply Adaptimmune with copies of all correspondence to and from Patent Offices in respect of the Full Application, including copies of all documents generated in or with such correspondence.
9. Where any later filed patent application relates to the same TCR or subject matter as any previously filed Provisional Application or Full Application (Later Application), the following will apply:
a. The Parties shall use reasonable endeavours to agree on the contents of the Later Application within thirty (30) days of notification of Later Application under paragraph 1. Any disagreement as to scope and content of Later Application shall be resolved in favour of Immunocore save that Immunocore shall be obliged to include all mutations or combinations of mutations in the Later Application as are requested to be included by Adaptimmune;
b. Prior to publication of the subject matter of the earlier of the Provisional Application or Full Application, the Parties shall discuss and agree whether the Provisional Application, Full Application and any Later Application should be withdrawn and re-filed to incorporate subject matter and/or claims from all of the Provisional Application, Full Application and Later Application. The Parties agree that where any Full Application or Later Application which has been filed relates to any Adaptimmune Product in relation to which clinical trials have been started or in relation to which a clinical trial is pending, the Full Application or Later Application shall not be withdrawn and re-filed.
c. Where the Parties do not agree in relation to the withdrawal and re-filing of the Provisional Application, Full Application and any Later Application or the contents of any re-filed Later Application, Immunocore shall have the right to file the Later Application but shall be obliged to include all mutations or combinations of mutations requested to be included by
Adaptimmune. Adaptimmune shall provide all its requested mutations and combinations of mutations within fourteen (14) days of written request from Immunocore. Pending receipt of such request, Immunocore will not file the Later Application or do anything which may jeopardise the filing, prosecution or maintenance of the Later Application.
d. Where the Parties agree that the Later Application should be withdrawn, Immunocore will withdraw the Later Application prior to its publication and the contents shall be maintained as confidential in accordance with Clause 7 of this Agreement. The Provisional Application and/or Full Application shall continue to be filed, maintained and prosecuted in accordance with paragraph 7 above.
10. Where the Parties agree to withdraw any Full Application and/or Provisional Application and/or Later Application and re-file or file the Later Application, the Parties shall use reasonable endeavours to agree the subject matter of such Later Application within a period of thirty (30) business days from agreement to withdraw and re-file. Any dispute shall be resolved in favour of Immunocore save that Immunocore shall be obliged to include all mutations or combinations of mutations in the Later Application as are requested to be included by Adaptimmune within such thirty (30) day period. Once the contents of the Later Application are agreed or deemed agreed, Immunocore shall be responsible for the filing, prosecution and maintenance of the Later Application. The Later Application shall be filed in the joint names of the Parties and Immunocore shall file, prosecute and maintain such application in accordance with the following:
a. use best endeavours to file, obtain and maintain valid patents pursuant to the Later Application so as to secure the broadest monopoly reasonably available in the countries chosen by Immunocore after consultation with Adaptimmune. Such countries shall include as a minimum the Required Countries unless otherwise agreed with Adaptimmune in writing;
b. ensure that Adaptimmune is kept fully informed, and consult with Adaptimmune in relation to all matters relating to the filing, prosecution and maintenance of the Later Application; and
c. supply Adaptimmune with copies of all correspondence to and from Patent Offices in respect of the Later Application, including copies of all documents generated in or with such correspondence.
Immunocore shall not be entitled to remove any mutations or combinations of mutations from the claims of any Later Application or re-filed Later Application (or any patent, patent application, divisional or continuation of such Later Application or re-filed Later Application) without the prior written consent of Adaptimmune unless any relevant patent office has provided a final non-appealable opinion that such mutation or combination of mutations is not patentable or capable of patent protection.
11. Immunocore shall maintain Granted Patents in accordance with the following:
a. Use best endeavours to maintain valid patents pursuant to the Granted Patents to the extent valid patents have not already been granted as at the Effective Date;
b. Pay all renewal and grant fees associated with such Granted Patents in the country in which such Granted Patent has been granted as at the Effective Date or in relation to which the Granted Patent is granted subsequent to the Effective Date;
c. Ensure that Adaptimmune is kept fully informed of any substantive communications in relation to such Granted Patents including communications and payment of renewal and grant fees.
The provisions of paragraphs 1-10 of this Schedule 3 shall not apply to any Granted Patents.
12. There shall be no obligation on either Party to maintain, prosecute, seek to re-instate, reissue or otherwise re-file any Lapsed Patent (as designated in accordance with Schedule 1) and the obligations set out under Schedule 3 shall not apply to any Lapsed Patents.
13. Immunocore shall file, prosecute and maintain Core Patents in accordance with the following:
a. Use best endeavours to file, obtain and maintain valid patents pursuant to the Core Patents so as to secure the broadest monopoly reasonably available in countries chosen by Immunocore, but at a minimum including the Required Countries unless otherwise agreed in writing with Adaptimmune;
b. To the extent such Core Patents are granted in any countries as at the Effective Date, to pay all renewal and grant fees associated with such granted Core Patents in the country in which such Core Patent has been granted as at the Effective Date;
c. Ensure that Adaptimmune is kept fully informed and to the extent reasonably possible consult with Adaptimmune in relation to any substantive communications to or from any Patent Office in relation to such Core Patents.
Adaptimmune understands and accepts that subject to the obligations imposed under this paragraph 13, Immunocore has the final decision in relation to the content of the Core Patents and the content of any communications relating to such Core Patents with any Patent Office.
The provisions of paragraphs 1-10 of this Schedule 3 shall not apply to any Core Patents.
14. Adaptimmune will reimburse Immunocore, within 30 days of the date of an invoice from Immunocore, for fifty per cent (50%) of the reasonable costs (including patent agent costs), fees and charges incurred by Immunocore in the course of filing, prosecuting and maintaining the patents and patent applications in accordance with this Schedule 3 (including as relevant Granted Patents and Core Patents). Such invoice will set out an itemised list of the costs incurred by Immunocore to a level of detail reasonably satisfactory to Adaptimmune. Adaptimmune may also request copies of invoices received from third Parties including patent agent costs.
15. If, at any time during the term of this Agreement, either Party (Notifying Party) no longer wishes to prosecute, file or maintain any of the Licensed Patents, it shall provide at least thirty (30) days notice to the other Party (Recipient Party). The Recipient Party shall be entitled in its sole discretion to take over and prosecute, file and maintain any notified patent or patent application. The Recipient Party shall make such decision within thirty (30) days of receiving notice from the Notifying Party. The Notifying Party shall assign its rights in such notified patent or patent application to the Recipient Party and the Notifying Party agrees to use all reasonable endeavours to
consent to and procure the signing of all documentation required to transfer full title in the notified patent or patent application to the Recipient Party. Following assignment, the Recipient Party shall be solely responsible for controlling and paying all the costs of prosecution, filing and maintenance of the assigned patent or patent application. Following assignment the Notifying Party shall have no further interest in the invention and patent or patent application shall be removed from the definition of Licensed Patents.
16. Where Recipient Party states in writing that it does not want to take over and prosecute, file and maintain any patent or patent application notified under paragraph 15 above, Notifying Party shall be entitled to allow such patent or patent application to lapse either through non-response to any office action or through non-payment of any fees due and payable in relation to such patent or patent application or by withdrawal of such patent or patent application. Where such patent or patent application has not been published as of the date the Recipient Party states it does not want to take over the prosecution, filing and maintenance, the Notifying Party shall use reasonable efforts to procure lapse or withdrawal of the Licensed Patent prior to its publication.
17. Prior to any decision being made by Recipient Party under paragraph 15 above, Immunocore or as relevant Adaptimmune (where Adaptimmune has taken over filing, prosecution and maintenance under paragraph 20 below) shall continue to prosecute, file and maintain the relevant patent or patent application in accordance with paragraphs 8, 10, 11 and 13 above (as relevant) and shall not do anything to jeopardise the filing, prosecution and maintenance of such patent or patent application.
18. Each Party will inform the other Party promptly if it becomes aware of any opposition, revocation, re-examination, interference or other action attacking or challenging the validity of any of the Licensed Patents. Where such challenge relates solely to claims covering Adaptimmune Licensed Products, Adaptimmune shall be entitled (but not obliged) to defend any such challenge. Where such challenge relates solely to claims covering Immunocore Licensed Products, Immunocore shall be entitled (but not obliged) to defend any such challenge. Where any challenge does not relate solely to either the Immunocore Licensed Products or the Adaptimmune Licensed Products or there is any dispute as to such, then (a) Adaptimmune shall be entitled (but not obliged) to defend any such challenge in relation to Provisional or Full Applications and Immunocore agrees to assist Adaptimmune in any such defence; and (b) Immunocore shall be entitled (but not obliged) to defend any such challenge in relation to any re-filed Later Application, Later Application, Granted Patent or Core Patent and Adaptimmune agrees to assist Immunocore in such defence. Where reasonably possible each Party will act in the best interests of the other Party in defending any such challenge.
19. Each Party will inform the other Party promptly if it becomes aware of any infringement or potential infringement of any of the Licensed Patents in the Field, and the Parties will consult with each other to decide the best way to respond to such infringement. If the Parties fail to agree on a joint programme of action (and as relevant the sharing of costs in relation to such joint programme) within 14 days of notification of infringement or potential infringement then the following shall apply:
a. (i) Adaptimmune shall be entitled (but not obliged) to take action against the third Party at its sole expense for any infringement or potential infringement where such infringement or potential infringement relates to any product that contains cells that are transfected with genes encoding TCRs including any product containing cells that may also be transfected
with one or more additional other molecules as well (whether transfected at the same time or by the same means as the TCRs or not); and (ii) any process, service or method relating solely to any product that contains cells that are transfected with genes encoding TCRs, in each case excluding any infringement or potential infringement of any Core Patent;
b. Immunocore shall be entitled (but not obliged) to take action against the third Party at its sole expense for any infringement or potential infringement where such infringement or potential infringement relates to (i) any product that contains Soluble TCRs and any process, service or method relating to such a product; and (ii) any Core Patent.
c. The other Party agrees to be joined in any suit to the extent necessary to enforce such rights subject to being reimbursed and secured in a reasonable manner as to any costs, damages, expenses, or other liability and shall have the right to be separately represented by its own counsel at its own expense.
20. Should Immunocore fail to file, maintain or prosecute any patent or patent application in accordance with this Schedule 3, Adaptimmune may provide Immunocore with thirty (30) days notice of such failure. Where such failure is not corrected within the thirty (30) day notice period, Adaptimmune may serve a further written notice to take over the filing, prosecution and maintenance of such Licensed Patents. Immunocore shall provide all reasonable assistance required by Adaptimmune in relation to the transition of the filing, prosecution and maintenance of such patents and/or patent applications to Adaptimmune.
21. Where Adaptimmune takes over the filing, prosecution and maintenance of any of the patents or patent applications under paragraph 20 above, paragraph 14 shall cease to apply. Adaptimmune will file, prosecute and maintain any patents or patent applications in accordance with the obligations previously imposed on Immunocore. Immunocore will reimburse Adaptimmune, within thirty (30) days of the date of an invoice from Adaptimmune, for fifty per cent (50%) of the reasonable costs (including patent agent costs), fees and charges incurred by Adaptimmune in the course of filing, prosecuting and maintaining patent and patent applications under this Schedule 3. Such invoice will set out an itemised list of the costs incurred by the Adaptimmune to a level of detail satisfactory to the Immunocore. Immunocore may also request copies of invoices received from third Parties including patent agent costs.
22. This Schedule 3 shall apply to the filing of patents and patent applications in relation to Results, Know-How or the Licensed Patents both during the term of this Agreement and following any termination or expiry of this Agreement.
Schedule 4A
Project Schedule Template
The following information should be agreed between the Parties in relation to any Project covered by this Agreement:
Project start date |
|
[Insert start date, if known] |
|
|
|
Project ID |
|
[Insert unique Project ID] |
|
|
|
Project TCR Source |
|
[Insert details of TCR receptor or receptors source] |
|
|
|
Target |
|
[Insert detail of relevant target or targets] |
|
|
|
Project Scope |
|
[insert details of scope of project] |
MHC Allele |
|
[Insert details of MHC allele] |
Sequence of wt epitope |
|
[Insert wt sequence details] |
TRAV |
|
|
TRBV |
|
|
In-licensed |
|
[Insert indication as to whether any IP or materials have been in-licensed] |
Project Details |
|
[Insert scope of project e.g. research and determination of possible mutations in relation to listed TCRs] |
|
|
|
Project Deliverables |
|
[Insert project deliverables] |
|
|
|
Project manager assigned by Immunocore |
|
[Insert name of project manager] |
|
|
|
Project manager assigned by Adaptimmune |
|
[Insert name of project manager] |
|
|
|
Assignment of tasks and project timelines |
|
[Insert list of tasks to be completed by each Party along with timelines] |
|
|
|
|
|
|
Project Completion |
|
[Insert when project will be completed and likely end date]. |
|
|
|
Agreed to be a Project under Exclusive Licence by Immunocore |
|
Signature:
Name:
Date: |
|
|
|
|
|
|
Agreed to be a Project under Exclusive Licence by Adaptimune |
|
Signature:
Name:
Date: |
Schedule 4B
Projects agreed as at Effective Date
Unique ID |
TCR Source
|
Target
|
MHC allele
|
Sequence of wt
|
In-
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c001 |
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c003 |
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c004 |
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c005 |
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c006 |
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c007 |
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c008 |
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c009 |
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c010 |
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c011 |
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c012 |
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c013 |
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c014a |
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c014b |
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c015 |
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c021 |
*** |
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*** |
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*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
c022 |
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c023 |
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c024 |
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c025 |
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c026 |
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c028 |
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c029 |
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c30 |
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c31 |
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c32 |
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c027 |
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*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
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*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
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c084 |
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*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
|
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c085 |
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c086 |
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c088 |
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c089 |
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c090 |
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*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
SCHEDULE 5
PATENT PROCESS TEMPLATE
This template may be completed for each new patent family/ notification to record steps taken in accordance with this Agreement and, in particular, Schedule 3 of this Agreement. Should there be any conflict between any template and Schedule 3, the provisions of Schedule 3 shall supersede and override any template unless Schedule 3 is explicitly stated to be amended and such amendment is agreed to in writing by both Parties.
Immunocore agrees to use reasonable endeavours to complete this template and provide a copy to Adaptimmune following any changes or updates to this template.
Step in patent process procedure. |
Action/ decision |
Authorisation by Parties | |
|
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| |
Assigned family number:
Granted patent details when available: |
| ||
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| |
Notification of invention |
Notification made by: |
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| |
|
Notification date: |
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| |
|
Notification relates to same TCR or subject matter as previously filed application: see template for [insert application details/ family number] for further information. |
|
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| |
|
Decision to maintain invention as confidential: |
|
Agreed by Immunocore:
Signature:
Date:
Agreed by Adaptimmune
Signature:
Date: |
|
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| |
|
Decision to file patent application: |
|
Agreed by Immunocore:
Signature:
Date:
Agreed by Adaptimmune
Signature:
Date: |
|
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|
N.B. Where no agreement is reached between the Parties: patent application will be filed. | |
|
|
|
Provisional Application filed |
Provisional Application details:
Date filed:
|
Content agreed by Immunocore:
Signature:
Date:
Content agreed by Adaptimmune
Signature:
Date: |
|
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|
N.B. Any dispute as to content to be resolved in favour of Adaptimmune. | |
| ||
Provisional Application withdrawn |
Provisional Application details:
Date withdrawn: |
Agreed by Immunocore:
Signature:
Date:
Agreed by Adaptimmune
Signature:
Date: |
|
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|
|
N.B. Any dispute to be resolved in favour of Adaptimmune. | |
|
|
|
Provisional Application withdrawn and re-filed |
Provisional Application details:
Date withdrawn:
Date new provisional filed:
New Provisional Application details: |
Agreed by Immunocore:
Signature:
Date:
Agreed by Adaptimmune
Signature:
Date: |
|
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|
|
N.B. Any dispute to be resolved in favour of Adaptimmune. | |
|
|
|
Full Application filed |
Full Application details:
Date filed: |
Content agreed by Immunocore:
Signature: |
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|
Date:
Content agreed by Adaptimmune
Signature:
Date: |
|
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|
N.B. Any dispute as to content to be resolved in favour of Adaptimmune. | |
|
|
|
Later Application notified |
Notification made by: |
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|
Notification date: |
|
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|
|
|
Provisional Application to be withdrawn:
Date withdrawn:
|
Agreed by Immunocore:
Signature:
Date:
Agreed by Adaptimmune
Signature:
Date: |
|
|
|
|
Full Application to be withdrawn:
Date withdrawn: |
Agreed by Immunocore:
Signature:
Date:
Agreed by Adaptimmune
Signature:
Date: |
|
|
|
|
Later Application to be re-filed: |
Agreed by Immunocore:
Signature:
Date:
Agreed by Adaptimmune
Signature:
Date: |
|
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|
|
Later Application re-filed:
Application details: |
Content agreed by Immunocore:
Signature: |
|
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|
Date filed: |
Date:
Content agreed by Adaptimmune
Signature:
Date: |
|
|
|
|
N.B. Where no agreement on withdrawal of Provisional Application or Full Application, Immunocore can file Later Application but must include all Adaptimmune requested mutations:
Date Later Application filed:
Application details: | |
|
|
|
Responses to Official Actions/ Search Reports/ Examination reports |
Details of office action/ notification etc:
|
Response agreed by Immunocore:
Signature:
Date:
Response agreed by Adaptimmune
Signature:
Date: |
|
|
|
Changes to claim scope |
Details of changes made/ response to office action/ opposition: |
Changes agreed by Immunocore:
Signature:
Date:
Changes agreed by Adaptimmune
Signature:
Date: |
|
|
|
Notification that either Party wishes to cease being involved in prosecuting/ filing or maintaining any Licensed Patent |
Notification made by:
Notification date:
Licensed Patent(s) affected: |
Agreement by other Party to take over prosecution, filing and maintenance of Licensed Patent:
Signature:
Date: |
|
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|
|
Date title to patent transferred to Party taking over prosecution, filing and maintenance of Licensed Patent: |
|
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|
If Party is not taking over prosecution, filing and maintenance of Licensed Patent, date of lapse or withdrawal: |
|
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|