Exhibit 10.1

 

Certain confidential information contained in this document, marked by [***],
has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed

 

CONFIDENTIAL FINAL

 

 

COLLABORATION AGREEMENT

 

BETWEEN

 

ADAPTIMMUNE LIMITED

 

AND

 

NOILE-IMMUNE BIOTECH INC

 

 

 

 

TABLE OF CONTENTS

 

Article     Page         ARTICLE 1  DEFINITIONS  3 ARTICLE 2  GOVERNANCE  12
ARTICLE 3  NOMINATION OF TARGETS  13 ARTICLE 4  RESEARCH PLAN  14 ARTICLE 5 
REGULATORY  16 ARTICLE 6  COMMERCIALISATION  17 ARTICLE 7  LICENSES  18 ARTICLE
8  TECHNOLOGY TRANSFER  18 ARTICLE 9  FINANCIAL TERMS  19 ARTICLE 10  PAYMENTS 
22 ARTICLE 11  INTELLECTUAL PROPERTY; OWNERSHIP  23 ARTICLE 12  CONFIDENTIALITY 
27 ARTICLE 13  PUBLICITY; PUBLICATIONS; USE OF NAME  29 ARTICLE 14 
REPRESENTATIONS  29 ARTICLE 15  INDEMNIFICATION  30 ARTICLE 16  TERM AND
TERMINATION  32 ARTICLE 17  DISPUTE RESOLUTION  35 ARTICLE 18  ANTI-BRIBERY  37
ARTICLE 19  DATA PROTECTION  37 ARTICLE 20  MISCELLANEOUS  38

 

Exhibits

 

Exhibit 1 – Research Plan

Exhibit 2 – Payments

Exhibit 3 – Data Protection

Exhibit 4 – Governance

Exhibit 5 – Noile-Immune Patents

Exhibit 6 – Press Release

 

  Page 2

 

 

COLLABORATION AGREEMENT

 

This collaboration Agreement (“Agreement”) is made and entered into on 26th
August 2019 “Effective Date”) BETWEEN

 

(A)ADAPTIMMUNE LIMITED having its principal place of business at 101 Park Drive,
Milton Park, Abingdon, Oxon, OX14 4RX, United Kingdom (“Adaptimmune”); and

 

(B)NOILE-IMMUNE BIOTECH INC having its principal place of business at
(“Noile-Immune”).

 

Noile-Immune and Adaptimmune are sometimes referred to herein individually as a
“Party” and collectively as the “Parties.”

 

BACKGROUND:

 

(A)Adaptimmune is a biotechnology company that is engaged in research and
development of TCR therapies for pharmaceutical therapy use.

 

(B)Noile-Immune is a biotechnology company that is engaged in research and
development of cancer immunotherapies for pharmaceutical therapy use.

 

(C)Noile-Immune and Adaptimmune desire to collaborate in relation to the
research and development of products that combine Adaptimmune’s TCR therapies
with Noile-Immune’s IL7/CCL19 technology.

 

(D)Following the development of product candidates, Adaptimmune will take such
candidates forward in to preclinical testing and later clinical trials and
commercialization.

 

(E)Based on the foregoing premises and the mutual covenants and obligations set
forth below, the Parties agree as follows.

 

THE PARTIES AGREE:

 

1.           DEFINITIONS

 

Capitalized terms used in this Agreement, whether used in the singular or
plural, shall have the meanings set forth below or elsewhere herein, unless
otherwise specifically indicated herein.

 

Accounting Standard means, either (a) International Financial Reporting
Standards (“IFRS”) or (b) US generally accepted accounting principles (“GAAP”),
in either case, which standards or principles (as applicable) are currently used
at the applicable time, and as consistently applied, by the applicable Party;  
  Acquiring Third Party means a Third Party (including in each case any entity
which directly or indirectly controls, is controlled by, or is under common
control with such Third Party) which, as at the date of the Change of Control,
controls or owns [***];       Adaptimmune Background IP means Background IP
Controlled by Adaptimmune or its Affiliates;     Adaptimmune Foreground IP means
any Foreground IP Controlled by Adaptimmune or its Affiliates, and as defined
further in Article 12;

 

  Page 3

 

 

Adaptimmune Licensed IP any Intellectual Property Rights Controlled by
Adaptimmune or its Affiliates (including Patents) which are necessary for the
performance of the Research Plan;     Adaptimmune Technology shall mean
technology created or developed by Adaptimmune outside of the performance of
this Agreement including [***];     Affiliate means any Person that, directly or
indirectly (through one or more intermediaries) controls, is controlled by, or
is under common control with a Party.  For purposes of this Clause, “control”
means the direct or indirect ownership of more than fifty percent (50%) of the
voting stock or other voting interests or interest in the profits of the Party;
    Agreement means this Agreement;     Alliance Manager means the individual
appointed by each Party as the principal point of contact for communication
between the Parties under this Agreement and in accordance with Exhibit 4;    
Applicable Laws means all applicable international, multi-national, national,
regional, state, provincial and local laws, rules, regulations, ordinances,
declarations, requirements, directives, guidance, policies and guidelines which
are in force during the Term and in any jurisdiction in which any Clinical Trial
or other activity under this Agreement is performed or in which any Product is
manufactured, sold or supplied to the extent in each case applicable to any
Party to this Agreement, including, as applicable to activities hereunder, the
regulations and regulatory guidance promulgated by the FDA, the Consolidated
Guidance E6 on Good Clinical Practice adopted by the International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use, as ratified by the FDA and the Clinical Trials Directive (Directive
2001/20/EC of 4th April 2001) and the respective implementing legislation, the
conditions and requirements imposed by the related ethics committee and any of
the foregoing which relate to ethical business conduct, the import or export of
goods, technical data or other items, and data protection and privacy rules, as
any of the foregoing may be amended from time to time;     [***] [***].    
Background IP means all Intellectual Property Rights Controlled by either Party
as of the Effective Date or during the Term, but excluding the Foreground IP;  
  Change of Control means with respect to a Party, (a) the sale or disposition
to an Acquiring Third Party of all or substantially all of the business or
assets of such Party to which the subject matter of this Agreement relates,
including all of or substantially all of the Licensed Intellectual Property
under which such Party has granted rights to the other Party under this
Agreement; or (b) (i) the acquisition by an Acquiring Third Party of more than
fifty percent (50%) of the issued voting shares or stock in such Party, or (ii)
the acquisition, merger or consolidation of such Party with or into an Acquiring
Third Party.  A Change of Control will not include an acquisition, merger or
consolidation or similar transaction of a Party in which the holders of the
voting shares in such Party immediately prior to such acquisition, merger,
consolidation or transaction, will beneficially own, directly or indirectly, at
least fifty percent (50%) of the voting shares in the Acquiring Third Party or
the surviving entity in such acquisition, merger, consolidation or transaction,
as the case may be, immediately after such acquisition, merger, consolidation or
transaction;

 

  Page 4

 

 

Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial, Phase
III Clinical Trial, or Phase IV Clinical Trial, as the case may be, and any
clinical studies specifically including pediatric subjects, or any other
equivalent, combined or other trial in which any Product is administered to a
human subject;     CMC means chemistry, manufacturing and control;    
Commercially Reasonable Efforts means, on a Party-by-Party basis, that level of
efforts and resources required to carry out a particular task or obligation in
an active and sustained manner, consistent with the general practice followed by
the Party in the exercise of its reasonable business discretion relating to
other pharmaceutical therapies or products owned by it, or to which it has
exclusive rights, which are of similar market potential at a similar stage in
their development or life, taking into account issues of patent coverage, safety
and efficacy, therapy profile, the competitiveness of any therapy in development
and in the marketplace, supply chain management considerations, the proprietary
position of the product or therapy, the regulatory structure involved, the
profitability of the applicable therapies (including pricing and reimbursement
status achieved), and other relevant factors, including technical, legal,
scientific and/or medical factors;     Confidential Information means
non-public, proprietary information (of whatever kind and in whatever form or
medium, including copies thereof), tangible materials or other deliverables (a)
disclosed by or on behalf of a Party in connection with this Agreement, whether
prior to or during the Term and whether disclosed orally, electronically, by
observation or in writing, or (b) created by, or on behalf of, either Party and
provided to the other Party, or created jointly by the Parties, in the course of
this Agreement; provided, that, notwithstanding the foregoing, to the extent a
Party is allocated ownership of Intellectual Property Rights embodied by or
containing a given piece of information under this Agreement in accordance with
Article 11, such information shall be deemed to be solely the Confidential
Information of such Party regardless of which Party initially disclosed or
created such information;     Control or Controlled by means the rightful
possession by a Party, whether directly or indirectly and whether by ownership,
license (other than pursuant to this Agreement) or otherwise, as of the
Effective Date or during the Term, of the right (excluding where any required
Third Party consent cannot be obtained) to grant a license, sublicense or other
right to exploit as provided herein, without violating the terms of any
agreement with any Third Party;

 

  Page 5

 

 

Covers or Covered or Covering means, with respect to a particular Patent or
Intellectual Property Right and in reference to a particular compound, process
or Product (whether alone or in combination with one or more other ingredients)
that the use, manufacture, sale, supply, import, offer for sale of such compound
or product or use of such process would infringe a valid claim of such Patent in
the absence of any license granted under this Agreement or in the case of a
patent application would infringe the claim of such patent application if such
patent application was a granted patent;       Dispute is defined in Clause
17.1;     Effective Date is defined in the Preamble;     EMA means the European
Medicines Agency and any successor thereto;     Enforcement is defined in Clause
11.5.3;     EU means the member states of the European Union and Switzerland, or
any successor entity thereto performing similar functions and for the purposes
of this Agreement shall also be deemed to include the UK;     EU Major Market
Means any one of France, Germany, UK, Italy and Spain     Exclusive License is
defined in Clause 7.2;     Exclusive Target [***];     FDA means the US Food and
Drug Administration, or any successor entity thereto performing similar
functions;     Field means TCR T-cell based immunotherapies for the treatment of
cancer;       First Commercial Sale means, with respect to a particular Product,
the first sale of such Product to a Third Party following the obtaining of
Marketing Approval for such Product in any country, excluding, however, any
shipment or invoicing or other distribution of such Product for use (a) in a
Clinical Trial, (b) on a named patient basis, (c) for compassionate use, (d)
under Treatment IND, or (e) in any non-registrational studies (e.g., an
investigator initiated trial);     Foreground IP means any Intellectual Property
Rights created in the performance of this Agreement including under any Research
Plan;     GMP means all current Good Manufacturing Practices applicable to
biopharmaceuticals in the US and/or in the European Union, as are in effect from
time to time during the Term and in each case as applicable to the activities
being carried out under this Agreement;  

 

  Page 6

 

 

GLP means all applicable current Good Laboratory Practice standards for
laboratory activities for pharmaceuticals, as set forth in the FDA’s Good
Laboratory Practice regulations as defined in 21 C.F.R. Part 58 and/or the Good
Laboratory Practice principles of the Organization for Economic Co-Operation and
Development (“OECD”), and such standards of good laboratory practice as are
required by the European Union and other organizations and governmental agencies
in countries in which the relevant activity under this Agreement is being
performed;     GxP means any of the following as applicable to this Agreement:
GLP and GMP;     HLA means a human leukocyte antigen;     HLA Type means a human
leukocyte antigen type;     IND means an investigational new drug application
filed with the FDA pursuant to 21 CFR Part 312 before the commencement of
Clinical Trials of a Product, or any comparable or equivalent filing (including
any Clinical Trial Authorization filed in the EU) with any relevant regulatory
authority in any other jurisdiction required before the commencement of any
Clinical Trial in such jurisdiction;     Indemnitee is defined in Clause 15.3;  
  Indemnitor is defined in Clause 15.3;     Infringement is defined in Clause
11.5.1;     Intellectual Property Rights means Patents, rights to discoveries,
inventions, copyrights and related rights, trademarks, trade names and domain
names, rights in designs, rights in computer software, database rights, rights
in confidential information (including know-how) 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;     Joint IP is
defined in Clause 11.1.2;     JPT is defined in Exhibit 4;     Licensed
Intellectual Property means, as applicable, the Noile-Immune Licensed IP and the
Adaptimmune Licensed IP;     Loss or Losses is defined in Clause 16.1;     MAA
or Marketing Approval Application means a BLA, sBLA, NDA, sNDA and any
equivalent thereof in the US or any other country or jurisdiction.  As used
herein: “BLA” means a Biologics License Application and amendments thereto filed
pursuant to the requirements of the FDA, as defined in 21 C.F.R. § 600 et seq.,
for FDA approval of a Product and “sBLA” means a supplemental BLA; and “NDA”
means a New Drug Application and amendments thereto filed pursuant to the
requirements of the FDA, as defined in 21 C.F.R. § 314 et seq., for FDA approval
of a Product and “sNDA” means a supplemental NDA;  

 

  Page 7

 

 

[***] [***];     Net Sales

of a Product, means the [***].

 

Net Sales will be calculated on a Product by Product and country by country
basis.

 

[***].

 

Sales of Products between the Licensee and the Licensee's Affiliates and/or
Sublicensees shall be excluded from the computation of Net Sales. 

 

The supply of Products for use (a) in a Clinical Trial; (b) on a named patient
basis; (c) for compassionate use; or (d) under Treatment IND shall be excluded
from the computation of Net Sales.

 

For Combination Products:

 

In the event of a sale of a Combination Product and where such Combination
Product is supplied for a single price, the following shall apply:

 

(i) where the Basic Product and the other active agent is sold separately in the
same country and to the extent the Average Sales Price of the Basic Product is
known or can be calculated, the Average Sales Price of the Basic Product will be
used for computation of Net Sales; and

 

(ii) where the Average Sales price of the Basic Product is not known or cannot
be calculated (for example because Basic Product and other active ingredient are
not sold and priced separately), then the Average Sales Price invoiced for such
Basic Product, to be used in the calculation of Net Sales in accordance with the
above procedure,  shall be a reasonable amount based on the relative value of
the Basic Product and the other active ingredient(s) in the Combination Product,
as mutually agreed by the Parties acting in good faith and taking into
reasonable consideration the current average sale prices for products and/or
active ingredient(s) similar to Z within the Combination Product.

 

[***].

    Noile-Immune Background IP means Background IP Controlled by Noile-Immune or
its Affiliates;     Noile-Immune Foreground IP means any Foreground IP
Controlled by Noile-Immune or its Affiliates, and as defined further in Article
11;

 

  Page 8

 

 

Noile-Immune Licensed IP means (i) any Patents (including the Noile-Immune
Patents) Controlled by Noile-Immune or its Affiliates as of the Effective Date
or during the Term and which either (a) Cover a Product or Nominated Target, or
a method related to use or manufacture thereof; or (b) which would, in the
absence of the licences under this Agreement, be infringed by the performance of
the Research Plan or manufacture, supply, development or commercialisation of
any Product; and (ii) any other Intellectual Property Rights (excluding Patents)
which are necessary for the performance of the Research Plan or are otherwise
necessary for the exploitation of any rights granted under this Agreement
(including the Exclusive License)     Noile-Immune Patents Means the Patents
listed in Exhibit 5;     Noile-Immune Technology shall mean technology created
or developed by Noile-Immune outside of the performance of this Agreement
including [***];     Nominated Target A Target which has been nominated by
Adaptimmune and such nomination has been accepted by Noile-Immune in accordance
with either Clause 3.1.1 or Clause 3.1.2 of this Agreement;     Non-Publishing
Party is defined in Clause 13.3;     Party or Parties is defined in the
Preamble;     Patent(s) means any and all patents and patent applications and
any patents issuing therefrom or claiming priority therefrom, worldwide,
together with any extensions (including patent term extensions and supplementary
protection certificates) and renewals thereof, reissues, reexaminations,
substitutions, confirmation patents, registration patents, invention
certificates, patents of addition, renewals, divisionals, continuations, and
continuations-in-part of any of the foregoing;     Person means an individual,
sole proprietorship, partnership, limited partnership, limited liability
partnership, corporation, limited liability company, business trust, joint stock
company, trust, unincorporated association, joint venture or other similar
entity or organization;     Phase I Clinical Trial means a human clinical trial,
the principal purpose of which is preliminary determination of safety of a
Product in healthy individuals or patients as described in 21 C.F.R. §312.21(a),
or similar clinical study in a country other than the US;     Phase II Clinical
Trial means a human clinical trial, the principal purpose of which is a
preliminary determination of efficacy of a Product in patients being studied as
described in 21 C.F.R. §312.21(b), or similar clinical study in a country other
than the US; provided, that, to the extent there is any ambiguity as to whether
a given human clinical trial constitutes a Phase II Clinical Trial or a “Phase
I(b)” clinical trial, such trial shall be a Phase II Clinical Trial for the
purposes of this Agreement;

 

  Page 9

 

 

Phase III Clinical Trial means a human clinical trial (including a pivotal or
registrational trial), the principal purpose of which is to demonstrate
clinically and statistically the efficacy and safety of a Product for one or
more indications in order to obtain Marketing Approval of such Product for such
indication(s), as further defined in 21 C.F.R. §312.21(c) or a similar clinical
study in a country other than the US; provided, that, to the extent there is any
ambiguity as to whether a given human clinical trial constitutes a Phase III
Clinical Trial or a “Phase II(b)” clinical trial, such trial shall be a Phase
III Clinical Trial for the purposes of this Agreement;       Product

means cell therapy within the Field and in each case comprising both “X” plus
“Y” (as combined, the “Basic Product”) and optionally “Z”, where Z may be
coformulated, engineered in, or otherwise sold together as a kit with the Basic
Product and for a single price (any such therapy which includes a Basic Product
plus Z, a “Combination Product”), where:

 

·    “X” means a TCR-engineered human T-cell developed by Adaptimmune or its
Affiliates (a “TCR-T”) in in each case direct to a Nominated Target, alone or
including one or more other moieties or excipients in such TCR-T;

 

·    “Y” means the Noile-Immune Technology or any part of the Noile-Immune
Technology including any associated excipients; and

 

·    “Z” means any other active agent or moiety owned or Controlled by
Adaptimmune or its Affiliates or Sublicensees, or to which Adaptimmune, its
Affiliates or Sublicensees has access.

    Prosecute or Prosecute and Maintain or Prosecution and Maintenance means,
with respect to a Patent, all activities associated with the preparation,
filing, prosecution and maintenance of such Patent , as well as activities
associated with re-examinations, reissues, applications for patent term
adjustments and extensions, supplementary protection certificates and the like
with respect to that Patent, together with the conduct of interferences,
derivation proceedings, pre- and post-grant proceedings, the defense of
oppositions and other similar proceedings with respect to that Patent;    
Prosecuting Party means the Party responsible for Prosecution under Clauses 11.2
and 11.3 of this Agreement;     Publishing Party is defined in Clause 13.3;

 

  Page 10

 

 

Regulatory Approval means the technical, medical and scientific licenses,
registrations, authorizations and approvals required for marketing or use of a
Product (including approvals of, BLAs, IND applications, pre- and post-
approvals, and labeling approvals and any supplements and amendments to any of
such approvals) of any national, supra-national, regional, state or local
regulatory agency, department, bureau, commission, council or other governmental
entity, necessary for the development, manufacture, distribution, marketing,
promotion, offer for sale, use, import, export or sale of a Product in a
regulatory jurisdiction.  In the US, Regulatory Approval means approval of any
Marketing Approval Application or equivalent by the FDA.  Regulatory Approval
shall include obtaining any pricing reimbursement or other pricing approval
requirement;     Regulatory Authority means the FDA, EMA, any other regulatory
authority or body with regulation or governance over the performance of any part
of the activities under this Agreement;     Research Plan means a program of
activities and work for the development of a Product directed to a Nominated
Target and covering [***];     Research Term Means a period of [***], the first
[***] starting on the Effective Date     SAE means a serious adverse effect
resulting from any Clinical Trial or administration of a Product;    
Sublicensee means a Third Party or Affiliate who has been granted a sublicense
under any license under this Agreement;     SUSAR means a suspected unexpected
serious adverse reaction resulting from any Clinical Trial or administration of
any product or therapy to a human being;     Target means the protein or
biological molecule from which an HLA-presented antigen is derived, [***];    
TCR means T-cell receptor;     Term is defined in Clause 16.1;     Third Party
means any entity other than Adaptimmune or Noile-Immune or an Affiliate of
either of them;     Third Party Claims is defined in Clause 15.1;     Third
Party Infringement Claim is defined in Clause 11.6.1;     Title 11 is defined in
Clause 16.3;     UK means the United Kingdom

 

  Page 11

 

 

US means the United States of America and its territories and possessions;    
Valid Claim means, with respect to a particular country, a claim in an unexpired
Patent within the Noile-Immune Licensed Intellectual Property in such country
that has not lapsed or been disclaimed, revoked, held unenforceable,
unpatentable or invalid by a decision of a court or other governmental agency of
competent jurisdiction, unappealable or unappealed within the time allowed for
appeal, and that has not been admitted to be invalid or unenforceable through
re-examination, re-issue, disclaimer or otherwise, or lost in an interference
proceeding; and     VAT means, in the EU, value added tax calculated in
accordance with Council Directive 2006/112/EC and, in a jurisdiction outside the
EU, any equivalent tax.

 

2.            GOVERNANCE

 

2.1 Governance Generally.         2.1.1 JSC and JPT. There will be a Joint
Steering Committee (“JSC”) set up to oversee performance of this Agreement and
the relationship between the parties. Individual Research Plan specific Joint
Project Teams (“JPTs”) will be set up to oversee performance of any Research
Plan. Further ad hoc committees may be set up as required by the Parties.      
  2.1.2 The formation, composition, decision making, duration and
characterization of the JSC and JPTs are set out further in Exhibit 4.        
2.1.3 Alliance Managers. Within thirty (30) days of the Effective Date, each
Party shall appoint an Alliance Manager to be the principal point of contact for
communications under this Agreement. The Alliance Managers shall facilitate the
flow of information and collaboration between the Parties and assist in the
resolution of potential and pending issues and potential disputes in a timely
manner to enable the JSC and JPT in each case for so long as such committee(s)
are in existence, and the Parties to reach consensus and avert escalation of
such issues or potential disputes. Either Party may replace its Alliance Manager
at any time upon prior written notice (including by email) to the other Party’s
Alliance Manager. Each Party shall ensure that its Alliance Manager is capable
of performing the obligations required of an Alliance Manager under this
Agreement.

 

3.            NOMINATION OF TARGETS

 

3.1 Nomination of Targets.      

  3.1.1 During the Research Term, Adaptimmune has the right to nominate [***]
Targets for development of Products as part of a Research Plan; provided,
however, that the first Target to be nominated shall be as pursuant to clause
3.1.3 below.         3.1.2 During the Research Term, Adaptimmune may nominate
any Target by written notice (including by e-mail) to the Noile-Immune Alliance
Manager (“Nomination”). [***].

 

  Page 12

 

 

  3.1.3 The first Target is [***] and is nominated as of the Effective Date by
Adaptimmune and such nomination is hereby accepted by Noile-Immune as of the
Effective Date.         3.1.4 The Nomination will specify the name of the Target
by Prot ID number and the HUGO gene name.         3.1.5 The date on which
nomination of any Target is accepted by Noile-Immune in accordance with the
provisions of this clause 3.1 is the Acceptance Date. The Acceptance Date for
the first Target is the Effective Date.         3.1.6 Any nomination of Targets
outside of the Research Term shall only be possible with the mutual agreement of
the Parties.       3.2 [***]             3.2.1 [***].

 

4.            RESEARCH PLAN

 

4.1 Research Plan.           4.1.1 Following acceptance of any Nomination in
accordance with Clause 3.1.2 above, the Parties will use Commercially Reasonable
Efforts to agree a Research Plan covering all development activities for
development of a Product [***] for a Product to the Nominated Target identified
in the Nomination as soon as reasonably possible.         4.1.2 The Initial
Research Plan is set out in Exhibit 1 and the start date for the Initial
Research Plan will be the Effective Date.         4.1.3 The Parties will aim to
agree each Research Plan within a maximum period of [***] months from Acceptance
Date for applicable Target and each such Research Plan will contain similar
details and requirements as that set out for the Initial Research Plan. In
particular, each Research Plan (including the Initial Research Plan) shall
include, without limitation, (i) objective criteria and milestones for the
progress of the development activities with respect to each Product and (ii)
anticipated timeline thereof. The start date for any Research Plan other than
the Initial Research Plan will be the date of agreement to the Research Plan by
the Parties unless otherwise provided in such Research Plan.       4.2
Performance of Research Plan         4.2.1 Under each Research Plan, each Party
shall use Commercially Reasonable Efforts to perform any part of the Research
Plan assigned to it, including making resources available as and when required
and supplying any product, equipment or materials as and when required and
specified under the Research Plan. Each Party will provide all data and
deliverables as required to be generated by it in accordance with the Research
Plan.         4.2.2 The Parties may supplement the terms of this Agreement upon
mutual agreement, as necessary, with terms relating to manufacture and supply,
quality and/or any other terms deemed necessary or reasonably useful by a Party
to govern the Parties’ development of any Product. The Parties will negotiate
any such supplemental terms in good faith and on a timely basis to prevent any
unreasonable delay to activities performed under the Research Plan.        
4.2.3 Each Party will discuss in good faith and agree at each stage whether any
Product proceeds to the next phase of any Research Plan. [***].

 

  Page 13

 

 

4.3 Sub-contractors. Each Party may subcontract portions of its work under the
Research Plan to (i) any Affiliate or (ii) Third Parties; provided in the case
of a Third Party, (a) there are no reasonably based objections from the other
Party regarding the use of said sub-contractor, and (b) such subcontract is in
writing and is consistent with the terms and conditions of this Agreement
including the confidentiality provisions of Article 12 and any rights granted to
such sub-contractor are restricted to only those rights necessary for
performance by such sub-contractor of the portions of work on behalf of the
sub-contracting Party. The sub-contracting Party will remain fully responsible
(at its cost) for all acts or omissions of any sub-contractor it appoints
(including any acts or omissions which result in a breach of the terms of this
Agreement) and shall ensure that each sub-contractor complies with the terms and
conditions of this Agreement. [***].     4.4 Completion of any Research Plan.
The term for a particular Research Plan shall commence on the start date for
such Research Plan and as further provided under clause 4.1. above, and shall
continue, unless earlier terminated in accordance with Article 16, until the
completion or waiver of all the tasks set out in the Research Plan, including
delivery of all data and deliverables. The final report for each Research Plan
shall include such data and research records that have been compiled [***]. For
the avoidance of doubt, nothing in this Clause 4.1 shall require either Party to
breach its obligations to any Regulatory Authority under Applicable Law and/or
its confidentiality obligations to any third party under relevant non-disclosure
agreement or other similar agreement. [***].

 

4.5 Reports and Records.         4.5.1 Progress Reports. Each Party shall keep
the other Party regularly informed of its activities (if any) under each
Research Plan and shall provide to the other Party’s representatives on the JPT
regular written summary updates at each JPT meeting. If reasonably necessary for
a Party to perform its work under a Research Plan, that Party may request that
the other Party provide more detailed information and data regarding the updates
it earlier provided, and the other Party shall promptly provide the requesting
Party with such information and data as is reasonably available and reasonably
necessary to conduct a Research Plan, and such other information as the Parties
agree. All such reports, information and data provided by a Party shall be
considered the providing Party’s Confidential Information.         4.5.2
Development Records. Each Party shall maintain records of its performance of
each, if any, Research Plan (or cause such records to be maintained) in
sufficient detail and in good scientific manner as will properly reflect all
work done and results achieved by or on behalf of such Party in the performance
of such Research Plan. All laboratory notebooks shall be maintained for no less
than [***] after creation of the relevant notebook entry. All other records
shall be maintained by each Party during the applicable Research Plan and for a
minimum of [***] thereafter. All such records of a Party shall be considered
such Party’s Confidential Information. Records shall not be destroyed by either
Party without prior written notification of such destruction being provided to
other Party, and other Party being given the opportunity to take over the
storage and responsibility for such records; provided, however, that for the
avoidance of doubt, any such records taken over by the other Party shall remain
the Confidential Information of the original Party and shall be subject to
confidentiality obligations under clause 12 under this Agreement.         4.5.3
Quality. Each Research Plan shall be performed at all times in accordance with
all Applicable Laws including as applicable requirements of GxP.

 

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4.6 Research Efforts. Each Party shall assign such scientific and technical
personnel and allocate such other resources as are reasonably necessary for
performing the activities as are assigned to it in each Research Plan and shall
perform such activities in accordance with all Applicable Laws (including GxPs)
in each case to the extent applicable to performance of the relevant Research
Plan activities by such Party, the terms and conditions of this Agreement, and
within generally accepted professional standards. Each Party shall be solely
responsible for the safety and health of its employees, consultants and
visitors, and for compliance with all Applicable Laws related to health, safety
and the environment, including providing its employees, consultants and visitors
with all required information and training concerning any potential hazards
involved in performing such activities and any precautionary measures to protect
its employees from any such hazards at its own facilities and as regards its or
its sub-contractor’s performance of the Research Plan. Each Party shall use
Commercially Reasonable Efforts to train its personnel assigned to perform
activities under this Agreement and ensure that any personnel so assigned shall
be capable of professionally and competently performing the activities assigned
to it in each Research Plan.       4.7 Audit of GXP activities. Adaptimmune may
request an on-site visit to Noile-Immune and/or its Affiliates and
Subcontractors for the purpose of conducting a quality assessment and/or quality
audit for any GXP activities performed by Noile-Immune, which visit Noile-Immune
will promptly accommodate. Adaptimmune shall be entitled to request such on-site
visit no more than once in any calendar year (except in the case of any
subsequent “for cause” audits) and any visit will be conducted to reasonably
minimize interference to the other Party’s business. All reasonable expenses
incurred for such audit shall be borne by the Party conducting such audit.    
4.8 Changes to Research Plan. The Parties acknowledge and agree that each
Research Plan will change and develop as the applicable Product progresses
through development. The JPT will be responsible for amending the Research Plan
as necessary in relation to any changes; provided that material changes to a
Party’s personnel and/or resources necessary for performance of such Research
Plan, or material changes to agreed milestones and anticipated timelines
thereof, must be mutually agreed by the Parties in writing (i.e., the JPT cannot
make such decisions).

 

5.            REGULATORY

 

5.1 Regulatory Matters.         5.1.1 As between the Parties, Adaptimmune shall
be responsible for holding and applying for any Regulatory Approvals or MAAs in
relation to the Product and for sponsoring any Clinical Trials (including
holding the IND). Adaptimmune shall have sole decision making authority in
relation to any sponsorship of any Clinical Trials or progression of any
Products through Clinical Trials and including the decision on whether to apply
for any MAAs.         5.1.2 Adaptimmune shall be primarily responsible, and act
as the sole point of contact, for communications with Regulatory Authorities in
connection with the development, commercialisation, and manufacturing of such
Product. To the extent Noile-Immune is required to provide any information or
response to a Regulatory Authority, such response will be discussed with
Adaptimmune to the extent practicable and responding Party shall provide only
such information as is necessary to comply with its legal obligations unless
otherwise mutually agreed. Noile-Immune shall copy Adaptimmune on any material
correspondence in relation to a Product (or anything which is likely to affect
the safety or regulatory approval of any Product) received from a Regulatory
Authority and where reasonably possible provide Adaptimmune an opportunity to
comment on such correspondence.         5.1.3 Notwithstanding the foregoing,
Noile-Immune shall provide such assistance as may reasonably be requested by
Adaptimmune relating to regulatory matters (including preparation and filing for
any INDs and MAAs and obtaining and maintaining Regulatory Approvals). Such
assistance will include, without limitation, a right to reference the other
Party’s DMF(s), IND(s), and other regulatory filings, and to reference and
utilize all toxicology/safety and other relevant scientific data developed by
Noile-Immune solely in connection with a Product. Noile-Immune shall provide a
letter of cross reference (or a letter of authorization) to Adaptimmune’s
regulatory filings upon request from Adaptimmune, to effectuate the provisions
of this Clause 5.1.3 or alternatively (and including where no letter of cross
reference is available) provide to Adaptimmune all relevant information in
relation to the Noile-Immune Technology as may be reasonably required by
Adaptimmune for Adaptimmune to prepare and file any documentation for any
Regulatory Approval or to respond to any Regulatory Authority.         5.1.4
Nothing in this Clause 5.1 shall require any Party to breach its obligations to
any Regulatory Authority under Applicable Law and/or its confidentiality
obligations to any third party under non-disclosure agreement or other similar
agreement.

 

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6.            COMMERCIALISATION

 

6.1 Commercialisation Generally. Adaptimmune shall use its Commercially
Reasonable Efforts to commercialise and promote any Product following its
decision to progress to filing an IND in relation to such Product. Adaptimmune
shall be primarily responsible for and shall have sole decision making authority
in relation to the commercialisation, manufacture and promotion of the Product
following filing of IND; [***].     6.2 Commercialisation Updates. Adaptimmune
shall keep Noile-Immune informed of its commercialisation of any relevant
Product and will provide [***] updates to Noile-Immune summarising progress in
the development and commercialisation of any Products in relation to which any
Research Plan has been completed.     6.3 Safety Event Reporting. Additionally,
each Party shall provide to the other Party prompt written notice of any
material safety events pertaining to any Product of which it becomes aware
including any SUSARs, SAEs or other material events which might have general
applicability to the development of any Product or the use of the Noile-Immune
Technology in patients. The Parties will agree the terms of a pharmacovigilance
agreement if reasonably required to facilitate such safety event reporting.

 

7.            LICENSES

 

7.1 Development License. Commencing on the Effective Date and continuing in full
force and effect until completion or termination of all Research Plan, each
Party hereby grants to the other Party a royalty-free, non-transferable (except
to such other Party’s agents performing the Research Plan), non-exclusive
license in the Field under such Party’s Licensed Intellectual Property solely
for the purposes of and to the extent necessary for performing the Research Plan
(collectively, the “Development License”). The Development License shall be
specific to the research and development activities and responsibilities of the
licensee Party under the Research Plan.       [***].     7.2 Exclusive License.
As from the Acceptance Date and on a Target by Target basis and country by
country basis, Noile-Immune grants to Adaptimmune a worldwide exclusive license
under Noile-Immune Licensed IP in each case to (i) make, have made, develop,
have developed use, import and have imported Products, and (ii) sell, have sold
and offer for sale Products, in each case of sub-Clauses (i) and (ii), in the
Field and directed to the corresponding Target (each, an "Exclusive License").
[***].     7.3 Sublicenses. Each Party shall have the right to sublicense the
licenses and rights granted under Clauses 7.1 and 7.2 to its Affiliates and
permitted sub-contractors (in accordance with clause 4.3) acting on its behalf.
Adaptimmune shall also have the right to sublicense the licenses and rights
granted under Clauses 7.1 and 7.2 (i) to any Third Party working in
collaboration with Adaptimmune to develop any Product and for the purposes of
such development; and (ii) to any Third Party which takes a license to any of
Adaptimmune’s rights in any Product and to the extent associated with such
license. Adaptimmune will provide prompt written notice of the grant of any
sublicense under clause 7.3(ii) to a Third Party. In each case such sublicense
must be:

 

  Page 16

 

 

  (a)      consistent with the terms and conditions of this Agreement; and      
(b)      in writing.       Each Party shall be responsible for all actions and
omissions of any Sublicensee including where such actions and omissions result
in a breach of the terms of this Agreement. Any other sub-licensing must be
prior approved in writing by the licensor Party.     7.4 No Additional Licenses.
Except as expressly provided in this Agreement, nothing in this Agreement shall
grant either Party any right, title or interest in and to the know-how, Patents
or other Intellectual Property Rights of the other Party (either expressly or by
implication or estoppel).

 

8.            TECHNOLOGY TRANSFER

 

8.1 In addition to any technology transfer contemplated by any Research Plan,
following completion of any Research Plan, Noile-Immune will:       8.1.1
reasonably assist Adaptimmune in establishing a CMC supply chain for any Product
and provide all information as may be reasonably required to enable Adaptimmune
to manufacture and supply any Product (including as relevant sequence
information, to the extent not already provided during the Research Plan),
unless by such provision of information Noile-Immune breaches its obligations to
any Regulatory Authority under Applicable Law and/or its confidentiality
obligations to any third party under non-disclosure agreement or other similar
agreement. Where any third party confidentiality obligations apply Noile-Immune
and Adaptimmune shall work together in good faith to facilitate the transfer of
any third party confidential information to Adaptimmune, including as relevant
Adaptimmune entering into confidentiality obligations direct with such third
party. Such assistance will include technical training sufficient to enable
Adaptimmune or its designated CMO to use such information and to make Products;
and         8.1.2 provide ongoing technical assistance in relation to
Adaptimmune's development and manufacturing of the Product as reasonably
requested from time to time and during the Term.         To the extent required,
the details of what technical assistance and transfer of technology will be
required from Noile-Immune will be agreed upon by the Parties as part of a
technology transfer plan to be initially prepared by Adaptimmune and approved by
the JPT. For the avoidance of doubt, nothing under this Section 8 shall
constitute or imply the assignment, conveyance or any other change of ownership
of any Intellectual Property Rights or other proprietary rights from
Noile-Immune to Adaptimmune on the basis of the technology transfer.

 

9.            FINANCIAL TERMS

 

9.1 Development Costs. Each Party will fund their own development costs and
activities unless otherwise explicitly agreed in writing. In particular each
Party will fund the completion of its activities under any Research Plan and
Adaptimmune will fund its preclinical testing and any Clinical Trials it
sponsors.     9.2 Upfront Payments. As upfront payments in relation to each
Nomination accepted by Noile-Immune pursuant to Section 3, Adaptimmune will pay
to Noile-Immune the amounts set out in Exhibit 2. Payments will be made as
provided in Exhibit 2.     9.3 Procedural Milestones. In addition to Clause 9.2,
Adaptimmune will pay to Noile-Immune the procedural milestone payments set out
in Exhibit 2 (“Procedural Milestones”) on achievement on the procedural events
set out in Exhibit 2 (“Procedural Milestone Events”). The following terms shall
apply to the payment of Procedural Milestones under this Clause 9.3.      

  Page 17

 

 

  9.3.1 Procedural Milestones shall be due only once for each Nominated Target
and shall apply in relation to the first Product directed to such Target to
achieve the Procedural Milestone Event. Should the same or additional Products
achieve the same Procedural Milestone Event more than once (for example for
multiple indications), no additional Procedural Milestones shall be payable by
Adaptimmune.         9.3.2 Procedural Milestones shall be due and payable
regardless of whether it is Adaptimmune or any Affiliate achieving such
Procedural Milestone Event or any Third Party achieving such Procedural
Milestone Event on behalf of Adaptimmune or its Affiliates.         9.3.3 If,
for any reason, a particular Procedural Milestone Event specified is achieved
with respect to a given Product without one or more preceding Procedural
Milestone Events with respect to such Product and Indication having been
achieved, then upon the achievement of such Procedural Milestone Event, both the
Procedural Milestones applicable to such achieved Procedural Milestone Event and
the Procedural Milestones applicable to such preceding unachieved Procedural
Milestone Event(s) shall be due and payable.         9.3.4 [***].         9.3.5
Where any Product within a Research Plan is replaced for any reason then
Procedural Milestones already paid in relation to the replaced Product shall not
be due and payable in relation to the replacement Product. Procedural Milestones
shall be due for the replacement Product where it reaches any Procedural
Milestone Event in relation to which a Procedural Milestone was not payable for
the replaced Product.         9.3.6 With respect to each Procedural Milestone
Event, Adaptimmune shall inform Noile-Immune within [***] days of the
achievement of such Procedural Milestone Event. Noile-Immune shall issue an
invoice for payment of the applicable Procedural Milestone and Adaptimmune shall
pay such invoice within [***] days of receipt of the relevant invoice.       9.4
Royalties.         9.4.1 Following First Commercial Sale of each Product,
Adaptimmune shall pay to Noile-Immune, on a Product by Product basis, and
subject to the terms of Clauses 9.4.2 to 9.4.5, [***] of Net Sales for any
Product based on annual worldwide Net Sales of such Product (“Royalty”).        
9.4.2 Royalties shall be payable on Net Sales of each Product in each country
during the Royalty Term and in each case where such Product is either (i)
Covered by a Valid Claim and such Valid Claim Covers the composition of matter
of the relevant Product itself, or approved use(s) for such Product, so long as
there are no other approved uses of such Product that are not Covered by such
Valid Claim; or (ii) in the absence of any Valid Claim, such Product benefits
from a period of market exclusivity granted in accordance with Applicable Laws,
including Orphan Drug Designation, and in each case for the duration of any
granted exclusivity period [***].         9.4.3 For the purposes of this Clause
9.4, a Valid Claim will not include the claims of any patent application [***].
        9.4.4 Payment Offsets. The following payment offsets will apply in
relation to the payment of any Royalty:

 

  Page 18

 

 

    (a)      [***].           (b)      Following the first commercial sale of a
Biosimilar in a country and such Biosimilar is not being commercialized by
Adaptimmune the royalties due and payable by Adaptimmune hereunder shall be
reduced [***] in such country. The reduction in Royalties under this Clause
shall only apply during the period of time that the Biosimilar is being sold by
a Third Party (excluding any Sublicensee) in such country [***]. As used herein,
“Biosimilar” means any drug or biological product that is subject to review
under an abbreviated approval pathway as a biosimilar, follow-on biologic or
generic biological product, as those terms are commonly understood under the
FD&C Act or the PHS Act and related rules and regulations, or the corresponding
or similar laws, rules and regulations of any other jurisdiction and where such
drug or biological product obtains Regulatory Approval based on, or in part on,
reference to any data or Regulatory Approval applicable to a Product hereunder.
        (3)      [***].         9.4.5 Royalty Term. The Royalty obligations set
forth in Clause 9.4.1 above will commence on a country-by-country and
Product-by-Product basis upon the First Commercial Sale of such Product in such
Country, and expire on a country-by-country and Product-by-Product basis upon
the [***] of (a) expiration of the last to expire Patent containing a Valid
Claim which Covers the composition of matter of such Product itself, or approved
use(s) for such Product so long as there are no other approved uses of such
Product that are not Covered by such Valid Claim in such country; or (b) [***].
        9.4.6 Rights Following Expiration of Royalty Term. Upon expiry of
Adaptimmune’s payment obligation hereunder with respect to a Product in a
country, the licenses in Article 7 shall be fully paid-up, irrevocable,
transferable and sublicenseable in respect of such Product in such country.    
    9.4.7 Royalty Reports. Following First Commercial Sale of a Product,
Adaptimmune shall provide a report to Noile-Immune within [***] of the end of
each calendar quarter (“Royalty Report”). The Royalty Report shall include (a)
the total Net Sales for Products to each Target worldwide; and (b) calculation
of the Royalty due to Noile-Immune. On receipt of such Royalty Report,
Noile-Immune will provide an invoice for the Royalty and Adaptimmune shall pay
such Royalty within 45 days of receipt of invoice.       9.5 Sales Milestones.
In addition to Clauses 9.2, 9.3 and 9.4, Adaptimmune will pay to Noile-Immune
the sales milestone payments set out in Exhibit 2 (“Sales Milestones”) on
achievement of the annual sales targets set out in Exhibit 2 (“Sales Milestone
Events”) in relation to the Product (or Products) for each Nominated Target. The
following terms shall apply to the payment of Sales Milestones under this Clause
9.5.         9.5.1 Sales Milestones shall be due only once for each Nominated
Target.         9.5.2 Sales Milestones shall be due and payable regardless of
whether it is Adaptimmune or any Affiliate achieving such Sales Milestone Event
or any Third Party achieving such Sales Milestone Event on behalf of Adaptimmune
or its Affiliates.         9.5.3 With respect to each Sales Milestone Event,
Adaptimmune shall inform Noile-Immune within [***] days of the achievement of
such Sales Milestone Event. Noile-Immune shall issue an invoice for payment of
the applicable Sales Milestone and Adaptimmune shall pay such invoice within
forty five (45) days of receipt of the relevant invoice.

 

  Page 19

 

 

10.            PAYMENTS

 

 

10.1 Mode of Payment.         10.1.1 All payments hereunder shall be made by
wire transfer in immediately available funds to the account listed below (or
such other account as the receiving Party shall designate before such payment is
due):           If to Noile-Immune:           [***]         10.1.2 Adaptimmune
will be responsible for any bank costs or charges associated with any transfer
of sums or reimbursement of costs including any currency conversion costs or
transfer costs.       10.2 Currency of Payments. All payments under this
Agreement shall be made in US dollars, unless otherwise expressly provided in
this Agreement. Net Sales shall be reported in US dollars irrespective of the
currency in which such sales were invoiced. Adaptimmune will make the conversion
to US dollars using the conversion rates it typically uses for its accounts and
in accordance with its application of the Accounting Standards.     10.3 Taxes.
Each Party shall comply with Applicable Laws regarding filing and reporting for
tax purposes.  Neither Party shall treat their relationship under this Agreement
as a pass through entity for tax purposes.  If any payments made by Adaptimmune
under this Agreement are subject to withholding taxes under Applicable Laws of
any state, federal, provincial or foreign government, Adaptimmune shall be
authorised to withhold such taxes as are required under such Applicable Laws,
pay such taxes to the appropriate government authority, and remit the balance
due to Noile-Immune net of such taxes.  Adaptimmune shall secure and deliver to
the other Party an official receipt for taxes paid.  The Parties will fully
cooperate with each other to enable each Party to more accurately determine its
own tax liability and to minimize such liability to the extent legally
permissible and administratively reasonable.  Each Party shall provide and make
available to the other Party any exemption certificates, resale certificates,
information regarding out of state or out of country sales or use of equipment,
materials or services, and any other information reasonably requested by the
other Party to support the provisions of this Clause 10.3, including the
appropriate organization of invoice formats and supporting documents to allow
maximization of reclamation of VAT and other transaction taxes.     10.4 Late
Payment. In relation to any undisputed amount required to be paid by Adaptimmune
hereunder which is not paid by the payment date due, Noile-Immune may charge
interest at a [***]; provided, however, that in no event will such rate exceed
the maximum legal interest rate then in effect. [***].     10.5 Records.
Adaptimmune shall keep and maintain records of its sales of Products in
sufficient detail to enable Noile-Immune to verify the accuracy of Royalties due
from Adaptimmune and pursuant to an inspection under Clause 10.6. Adaptimmune
shall keep such records for a period of [***] years from the end of the calendar
year in which the relevant Product sales were made.     10.6 Inspections.
Noile-Immune shall be entitled to appoint an independent Third Party qualified
accountant or a person possessing similar professional status and associated
with an independent accounting firm reasonably acceptable to Adaptimmune to
verify the level of Net Sales accounted for by Adaptimmune and the payment of
Royalty in accordance with this Agreement. Adaptimmune shall make its records
available as set forth in this Section. The accounting firm shall enter into
appropriate obligations with Adaptimmune to treat all information it receives
during its inspection in confidence. Such audit right shall apply [***]. The
independent Third Party shall only be entitled to report to Noile-Immune as to
whether or not the Net Sales of any Product are materially accurate. Where any
inspection identifies any shortfall in the Royalty required to Noile-Immune,
Adaptimmune shall make up such shortfall within [***] days of receiving notice
of such shortfall. Where any inspection identifies an overpayment in the
Royalties required to Noile-Immune, Adaptimmune shall be entitled to deduct the
amount of such overpayment from the next payment or payments made to
Noile-Immune. [***].

 

  Page 20

 

 

11.            INTELLECTUAL PROPERTY; OWNERSHIP

 

11.1 Disclosure; Ownership; Inventorship; Assignment and Cooperation.        
11.1.1 Disclosure. During the Term, each Party shall promptly disclose to the
other Party in writing any registerable or potentially registerable Foreground
IP (whether or not patentable) conceived or reduced to practice by or for the
disclosing Party in the course of performance of this Agreement. Disclosure will
be made via designated patent representatives for each Party.         11.1.2
Ownership. As between the Parties:           (a)       Adaptimmune shall solely
own any Foreground IP which solely relates to the Adaptimmune Technology [***]
(“Adaptimmune Foreground IP”) and Noile-Immune hereby assigns and agrees to
assign to Adaptimmune any rights it has in the Adaptimmune Foreground IP;      
    (b)       Noile-Immune shall solely own any Foreground IP which solely
relates to the Noile-Immune Technology [***] (“Noile-Immune Foreground IP”) and
Adaptimmune hereby assigns and agrees to assign to Noile-Immune any rights it
has in the Noile-Immune Foreground IP; and           (c)       The Parties shall
jointly own any Foreground IP other than that set out in clause 12.1.2 (a) and
(b) ("Joint IP").           In relation to any inventions, existence and
ownership of inventions shall be determined in accordance with the laws of the
United States. Without limiting the foregoing, each Party retains an undivided
one-half interest in and to the Joint IP (including Patents therein) and each
Party agrees to assign its rights in any Joint IP to the other Party to ensure
such joint ownership. Subject to the licenses granted in Article 7, (i) each
Party may [***], in each case of sub-clauses (i) and (ii), without accounting to
the other Party.           In the event of any dispute as to whether any
Foreground IP solely relates to either the Adaptimmune Technology or
Noile-Immune Technology under Clauses 11.1.2(a) or 11.1.2(b) and where such
dispute is not resolved by reference to senior executives in accordance with
Clause 17.1, an independent patent expert (“Patent Expert”) shall be appointed
by the Parties to resolve such dispute. The decision of the Patent Expert shall
be binding on the Parties in the absence of manifest error or fraud. The Patent
Expert shall be mutually agreed between the Parties in writing within thirty
(30) days of expiry of the 30-day resolution period in Clause 17.1. Where the
Parties cannot agree such Patent Expert, the Patent Expert shall be appointed by
the American Arbitration Association under its Supplementary Rules for the
Resolution of Patent Disputes. Any Patent Expert shall be a patent attorney and
have at least 20 years’ experience in relation to pharmaceutical or
biotechnology patent matters. The fees of the Patent Expert shall be shared
equally between the Parties and the Parties shall use reasonable efforts to
ensure resolution occurs as quickly as possible after referral to such Patent
Expert. The Parties shall reasonably cooperate with the Patent Expert, including
providing such information as may reasonably be required by the Patent Expert to
reach a decision.           Nothing in this clause shall affect or impact any
ownership of either Party in relation to such Party’s Background IP.

 

  Page 21

 

 

  11.1.3 Assignment; Cooperation. Each Party shall execute such further
documentation as may be necessary or appropriate, and provide reasonable
assistance and cooperation, to implement the provisions of this Article 11. Each
Party shall to the extent legally practicable and possible under relevant
national or local laws use Commercially Reasonable Efforts to cause all of its
employees, Affiliates and any Third Parties working pursuant to this Agreement
on its behalf, to assign (or otherwise convey rights) to such Party any Patents
and Know-How or other Foreground IP discovered, conceived or reduced to practice
by such employee, Affiliate or Third Party, and to cooperate with such Party in
connection with obtaining patent protection therefore.       11.2 Patent
Prosecution.       11.2.1 Adaptimmune Controlled Prosecution and Maintenance.  
        (a)       Adaptimmune shall, at its sole discretion and expense, have
the right (but not the obligation) to Prosecute and Maintain Patents within the
Adaptimmune Background IP.           (b)       Adaptimmune shall, at its sole
discretion and expense, have the right (but not the obligation) to Prosecute and
Maintain Patents within the Adaptimmune Foreground IP. [***]          
(c)       Adaptimmune shall, at its sole discretion and expense, have the right
(but not the obligation) to Prosecute and Maintain Patents within the joint
Foreground IP, to the extent such Patents [***]         11.2.2 Noile-Immune
Controlled Prosecution and Maintenance.           (a)       Noile-Immune shall,
at its sole discretion and expense, have the right (but not the obligation) to
Prosecute and Maintain Patents within the Noile-Immune Background IP.          
(b)       Noile-Immune shall, at its sole discretion and expense, have the right
(but not the obligation) to Prosecute and Maintain Patents within the
Noile-Immune Foreground IP. [***]       11.3 Jointly Controlled Prosecution and
Maintenance:       11.3.1 In relation to any Joint IP not Prosecuted and
Maintained by either Adaptimmune or Noile-Immune under Clauses 11.2.1 and
11.2.2, the Parties shall mutually agree upon which Party shall have the right
to Prosecute and Maintain such Patents.       11.4 [***]         11.5
Enforcement Rights for Infringement by Third Parties.       11.5.1 Notice. Each
Party shall promptly notify, in writing, the other Party upon learning of any
actual or suspected infringement of the Patents within the Noile-Immune
Background IP or any Foreground IP to the extent such actual or suspected
infringement is relevant to any Product, or, of any claim of invalidity,
unenforceability, or non-infringement of any Patents within the Noile-Immune
Background IP (to the extent relevant to any Product) or any Foreground IP (each
an “Infringement”).

 

  Page 22

 

 

  11.5.2 Enforcement Actions.           (a)        The Parties shall consult in
good faith as to potential strategies to terminate suspected or potential
Infringement. In the absence of any agreement otherwise, the Prosecuting Party
in relation to the relevant Patent or Party owning or Controlling the relevant
intellectual property right in the case of Foreground IP or Background IP shall
have the first right, but not the obligation, to seek to abate any actual or
suspected Infringement by a Third Party, or to file suit against any Third Party
for Infringement. If the Prosecuting Party or owning or Controlling Party does
not, within one hundred twenty (120) days of receipt of a notice under Clause
11.5.1, take steps to abate the Infringement, or to file suit to enforce against
such Infringement, then other Party shall have the right, but not the
obligation, to take action to enforce against such Infringement; provided that
if Prosecuting Party is diligently pursuing ongoing settlement discussions at
the end of such one hundred and twenty (120) day period then Non-Prosecuting
Party shall not be permitted to exercise such right unless such settlement
discussions cease without reaching settlement or Prosecuting Party ceases to
pursue such discussions diligently.           (b)        The non-Prosecuting
Party shall reasonably cooperate with the Party controlling any such action to
abate or enforce pursuant to this Clause 11.5.2 (as may be reasonably requested
by the controlling Party and at the controlling Party’s expense), including, if
necessary, by being joined as a party; provided that the non-controlling Party
shall be reimbursed by the controlling Party as to any costs or expenses
incurred, and shall have the right to be represented by its own counsel at its
own expense. The Party controlling any such action shall keep the other
non-Prosecuting Party updated with respect to any such action, including
providing copies of all documents received or filed in connection with any such
action.         11.5.3 Settlement. The Party controlling any such enforcement
action described in Clause 11.5.2 (a “Enforcement”), at its sole discretion, may
take reasonable actions to terminate any alleged infringement without
litigation; provided, that if any such arrangement would adversely affect the
non-controlling Party’s rights under this Agreement or impose any obligation or
requirement on the non-controlling Party, then that arrangement is subject to
the non-controlling Party’s prior written consent, which consent shall not to be
unreasonably withheld, conditioned or delayed.         11.5.4 Costs and
expenses. The Party controlling any Enforcement shall bear all of its costs and
expenses, including litigation expenses, related to such Enforcement actions.  
      11.5.5 Damages. Unless otherwise mutually agreed by the Parties in
writing, and subject to the respective indemnity obligations of the Parties set
forth in Article 15, all damages, amounts received in settlement (including
royalty, milestone or other payments), judgment or other monetary awards
recovered in Enforcement with respect to activities of the Third Party that
occurred prior to the effective date of such award shall be shared as follows:  
        (a)       first, to reimburse the controlling Party for costs and
expenses incurred under Clause 11.5.4; and           (b)       second, shall be
apportioned [***] to the controlling Party and [***] to the other
(non-controlling) Party.       11.6 Third Party Infringement Claims.      
11.6.1 Notice. In the event that a Third Party shall make any claim, give
notice, or bring any suit or other inter parties proceeding against Noile-Immune
or Adaptimmune, or any of their respective Affiliates, subcontractors or
customers, for infringement or misappropriation of any Intellectual Property
Rights with respect to the research, development, making, using, selling,
offering for sale, import or export of any Product or with respect to any
Nominated Target ("Third Party Infringement Claim"), in each case, the Party
receiving notice of a Third Party Infringement Claim shall promptly notify the
other Party in writing and provide all evidence in its possession pertaining to
the claim or suit that it is entitled to disclose.

 

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  11.6.2 Defense. The Parties shall consult as to potential strategies to defend
against any Third Party Infringement Claim, consistent with the overall goals of
this Agreement, including by being joined as a party. The Parties shall
cooperate with each other in all reasonable respects in the defense of any Third
Party Infringement Claim or raising of any counterclaim related thereto. Subject
to the respective indemnity obligations of the Parties set forth in Article 15,
(a) Adaptimmune shall be primarily responsible for defending such Third Party
Infringement Claim including selection of counsel, venue, and directing all
aspects, stages, motions, and proceedings of litigation to the extent such Third
Party Infringement Claim relates to any Product or Target or any Adaptimmune
Technology; and (b) subject to clause 11.6.2(a), Noile-Immune shall be primarily
responsible for defending such Third Party Infringement Claim including
selection of counsel, venue, and directing all aspects, stages, motions, and
proceedings of litigation to the extent such Third Party Infringement Claim
relates to the Noile-Immune Technology. If the Party with primary responsibility
does not, within one hundred twenty (120) days of receipt of a notice under
Clause 11.6.1 take steps to defend the Third Party Infringement Claim, then to
the extent that such Third Party Infringement Claim is brought against the other
Party, the other Party shall have the right, but not the obligation, to take
action to enforce or defend against such Third Party Infringement Claim;
provided that if the Party with primary responsibility is diligently pursuing
ongoing settlement discussions at the end of such one hundred and twenty (120)
day period, then other Party shall not be permitted to exercise such right
unless such settlement discussions cease without reaching settlement or such
responsible Party ceases to pursue such settlement discussions diligently. At
the controlling Party’s request and expense, the non-controlling Party shall
cooperate with the controlling Party in connection with any such defense and
counterclaim, provided that the non-controlling Party shall be reimbursed by the
controlling Party as to any reasonable and documented costs or expenses, and
shall have the right to be represented by its own counsel at its own expense.
Any counterclaim or other similar action by a Party, to the extent such action
involves any enforcement of rights under the Background IP, Foreground IP or
Joint IP, will be treated as an Enforcement subject to Clause 11.5. Nothing in
this Clause shall prevent any Party from complying with the terms of any court
order relating to or arising out of any Third Party Infringement Claim.        
11.6.3 Settlement. If any such defense under Clause 11.6.2 would adversely
affect the other Party’s rights under this Agreement or impose a financial
obligation upon the other Party or grant rights in respect, or affect the
validity or enforceability, of the other Party’s Intellectual Property Rights or
any Foreground IP, then any settlement, consent judgment or other voluntary
final disposition of such Third Party Infringement Claim shall not be entered
into without the consent of the other Party (such consent not to be unreasonably
withheld, conditioned or delayed).         11.6.4 Costs and Expenses. The Party
controlling the defense of any Third Party Infringement Claim shall bear all
costs and expenses, including litigation expenses, to defend against any Third
Party Infringement Claim.

 

12.            CONFIDENTIALITY

 

12.1 Non-use and Non-disclosure of Confidential Information. During the Term,
and for [***] years after the date of expiration or termination of this
Agreement, a Party shall (i) except to the extent permitted by this Agreement or
otherwise agreed to by the Parties in writing, keep confidential and not
disclose to any Third Party any Confidential Information of the other Party;
(ii) except in connection with activities contemplated by, the exercise of
rights permitted by or in order to further the purposes of, this Agreement or
otherwise agreed to by the Parties in writing, not use for any purpose any
Confidential Information of the other Party; and (iii) take all reasonable
precautions to protect the Confidential Information of the other Party
(including all precautions a Party employs with respect to its own confidential
information of a similar nature).      

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12.2 Exclusions Regarding Confidential Information. Notwithstanding anything set
forth in this Article 12 to the contrary, the obligations of Clause 12.1 above
shall not apply to the extent that the Party seeking the benefit of the
exclusion from the obligations set forth in Clause 12.1 (the receiving Party)
can demonstrate that the Confidential Information of the other Party:        
(a)       was already known to the receiving Party, other than under an
obligation of confidentiality, at the time of receipt by the receiving Party;  
   

    (b)       was generally available to the public or otherwise part of the
public domain at the time of its receipt by the receiving Party;          
(c)       became generally available to the public or otherwise part of the
public domain after its receipt by the receiving Party other than through any
act or omission of the receiving Party or those to whom the receiving Party
discloses in breach of this Agreement;           (d)       was received by the
receiving Party without an obligation of confidentiality from a Third Party
having the right (to the knowledge of the receiving Party) to disclose such
information without restriction;           (e)       was independently developed
by or for the receiving Party without use of or reference to the Confidential
Information of the other Party; or           (f)        was released from the
restrictions set forth in this Agreement and imposed on the receiving Party by
express prior written consent of the other Party.       12.3 Authorised
Disclosures of Confidential Information. Notwithstanding the foregoing, a
receiving Party may use and disclose the Confidential Information of the other
Party as follows:         (a)        if required by law, rule or governmental
regulation or by judicial order, including as may be required in connection with
any filings made with, or by the disclosure policies of, a major stock exchange;
provided that the receiving Party seeking to disclose the Confidential
Information of the other Party (i) uses all reasonable efforts to inform the
other Party of such requirement in writing prior to making any such disclosures
and cooperates with the other Party’s efforts to avoid or limit disclosure, or
to seek a protective order, confidential treatment or other appropriate remedy
(including redaction) and (ii) whenever possible, requests confidential
treatment of such information that is disclosed;           (b)       to the
extent such use and disclosure is reasonably required in the Prosecution and
Maintenance of a Patent within the Foreground IP in accordance with this
Agreement; provided that such proposed disclosure is provided to the other Party
in writing in advance and the other Party approves such disclosure;          
(c)        as reasonably necessary to obtain or maintain any Regulatory
Approval, including to conduct preclinical studies and Clinical Trials and for
pricing approvals, for any Products, provided, that, the disclosing Party shall
take all reasonable steps to limit disclosure of the Confidential Information
outside such Regulatory Agency and to otherwise maintain the confidentiality of
the Confidential Information;           (d)       to take any lawful action that
it deems necessary to protect its interest under, or to enforce compliance with
the terms and conditions of, this Agreement; or           (e)        to the
extent necessary, to permitted Sublicensees, vendors, consultants, agents,
attorneys, contractors and clinicians under written agreements of
confidentiality at least as restrictive as those set forth in this Agreement (or
as restrictive as reasonably possible), who have a need to know such information
in connection with such Party performing its obligations or exercising its
rights under this Agreement.

 

  Page 25

 

      12.4 Terms of this Agreement. The Parties agree that this Agreement and
the terms hereof will be considered Confidential Information of both Parties.  
  12.5 No License. As between the Parties, Confidential Information disclosed
hereunder shall remain the property of the disclosing Party. Disclosure of
Confidential Information to the other Party shall not constitute any grant,
option or license to the other Party, beyond those licenses expressly granted
under Article 7, under any patent, trade secret or other rights now or
hereinafter held by the disclosing Party.     12.6 Change of Control. In the
event of a Change of Control of a Party, such Party will adopt reasonable
procedures to [***]

 

13.            PUBLICITY; PUBLICATIONS; USE OF NAME

 

13.1 Publicity. The Parties shall agree and issue a joint press release, as set
out in Exhibit 6, concerning the execution of this Agreement on a mutually
agreed date. The text of any other press releases, public announcements or
PowerPoint presentations concerning this Agreement, the subject matter hereof,
or the research, development or commercial results of Therapies hereunder (a
“Release”) shall be addressed pursuant to Clauses 13.2 – 13.4, inclusive, as
applicable.     13.2 Releases required by Law or Regulation. Each Party may
issue any Release it is required to issue by Applicable Law (including
requirements of any law or rule imposed by the US Securities and Exchange
Commission or any securities exchange). For clarification, where any Party
reasonably believes, after consultation with outside legal counsel or General
Counsel, that any Release is required in order for it to comply with any
securities exchange requirement, including a required release of any material
information or an obligation to correct any market misstatement, such Party
shall be entitled to issue such Release in accordance with such reasonable
belief, without providing the other Party with any prior notification of such
Release.     13.3 Publications. Notwithstanding Clauses 13.2, both Parties
recognise that the publication or disclosure of papers, presentations, abstracts
or any other written or oral presentations regarding results of and other
information regarding the Products may be beneficial to both Parties, provided
that such publications or presentations are subject to reasonable controls to
protect Confidential Information, the patentability of inventions and other
commercial considerations. Accordingly, the following shall apply:       13.3.1
Any proposed paper, presentation, or other public disclosure regarding any
Product or Research Plan (“Publication”) by either Party (“Publishing Party”)
shall be provided to the other Party (“Non-Publishing Party”) for review. The
Non-Publishing Party shall review such proposed Publication within 20 days of
receipt and may comment on and/or object to any content of the proposed
Publication.         13.3.2 The Parties shall work together to resolve any
comments and objections of the Non-Publishing Party on a timely basis and
neither Party shall unreasonably withhold its consent to any proposed
Publication, save that a Non-Publishing Party may request deletion of any of its
Confidential Information from any such proposed Publication.         13.3.3 No
Publication shall be made unless the contents of such Publication are mutually
agreed between the Parties.       13.4 No Use of Names. Except as expressly
provided herein, no right, express or implied, is granted by the Agreement to
use in any manner the name of “Adaptimmune” or "Noile-Immune" or any of their
Affiliates, or any other trade name, symbol, logo or trademark of the other
Party or its Affiliates, in connection with the performance of this Agreement.

 

  Page 26

 

 

14.            REPRESENTATIONS

 

14.1 Mutual Representations and Warranties. Each Party represents and warrants
to the other Party that as of the Effective Date:       14.1.1 it is validly
organized under the laws of its jurisdiction of incorporation;         14.1.2 it
has obtained all necessary consents, approvals and authorizations of all
governmental authorities and other persons or entities required to be obtained
by it in connection with this Agreement;         14.1.3 the execution, delivery
and performance of this Agreement have been duly authorised by all necessary
corporate action on its part;         14.1.4 it has the legal right and power to
enter into this Agreement and to fully perform its obligations hereunder;      
  14.1.5 the performance of its obligations under this Agreement will not
conflict with such Party’s charter or incorporation documents or any Third Party
agreement, contract or other arrangement to which such Party is a party;        
14.1.6 it will comply with all Applicable Laws in the performance of this
Agreement;         14.1.7 it has not received any written letter threatening
infringement or alleging any infringement in relation to any Background IP which
to its actual knowledge will be required for performance of any Research Plan
and it has no actual knowledge that its Background IP infringes the rights of
any Third Party or has been misappropriated from any Third Party;         14.1.8
it will not use in the performance of this Agreement any person or personnel
(whether directly or through a subcontractor) that has been debarred or
otherwise prevented or restricted from performing any clinical research or has
been convicted of any offence related to any Clinical Trial in any jurisdiction
or otherwise prevented from performing any Clinical Trial by any Regulatory
Authority; and         14.1.9 it has the legal right and power to extend the
rights and licenses granted to the other Party hereunder.       14.2 [***].    
    14.3 Disclaimers.  EXCEPT AS OTHERWISE EXPRESSLY STATED IN THIS AGREEMENT,
NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT TO
PATENTS, KNOW-HOW, MATERIALS OR CONFIDENTIAL INFORMATION SUPPLIED BY IT TO THE
OTHER PARTY HEREUNDER, AND EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESS OR
IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE AND NON-INFRINGEMENT.  IN PARTICULAR BOTH PARTIES ACCEPT THAT, GIVEN THE
NATURE OF THE PRODUCTS BEING GENERATED UNDER THIS AGREEMENT, THERE CAN BE NO
GUARANTEE THAT ANY PRODUCT CAN BE SUCCESSFULLY GENERATED OR THAT IF GENERATED,
THE PRODUCT WILL BE CAPABLE OF OBTAINING REGULATORY APPROVAL.

 

  Page 27

 

 

15.            INDEMNIFICATION

 

15.1 Indemnification by Adaptimmune. Subject to Clause 15.3, Adaptimmune shall
indemnify, defend and hold Noile-Immune, its Affiliates and their respective
directors, officers, and employees and the successors and assigns of any of the
foregoing harmless from and against any and all liabilities, damages,
settlements, penalties, fines, costs or expenses (including reasonable
attorneys' fees and other reasonable expenses of litigation) (collectively,
“Loss” or “Losses”) to the extent arising out of or in connection with any Third
Party claims, suits, actions, demands or judgments (“Third Party Claims”)
relating to (a) the negligence or willful misconduct of Adaptimmune or its
Affiliates or any of its or their sub-contractors; and (b) any breach of
Applicable Laws by Adaptimmune or its Affiliates, Sublicensees or any of its or
their sub-contractors; and (c) any breach of the warranties under Article 14 by
Adaptimmune of its Affiliates except, in each case, to the extent caused by the
negligence or willful misconduct of Noile-Immune or its Affiliates or breach of
this Agreement by Noile-Immune or its Affiliates.     15.2 Indemnification by
Noile-Immune. Subject to Clause 15.3, Noile-Immune shall indemnify, defend and
hold Adaptimmune, its Affiliates and their respective directors, officers, and
employees and the successors and assigns of any of the foregoing harmless from
and against any and all Losses to the extent arising out of or in connection
with any Third Party Claims relating to (a) the negligence or willful misconduct
of Noile-Immune, its Sublicensees or any sub-contractor of Noile-Immune
(including its Affiliates); and (b) any breach of Applicable Laws by
Noile-Immune, its Affiliates, Sublicensees or sub-contractors; and (c) any
breach of the warranties under Article 14 by Noile-Immune of its Affiliates
except, in each case, to the extent caused by the negligence or willful
misconduct of Adaptimmune or its Affiliates or breach of this Agreement by
Adaptimmune or its Affiliates.     15.3 Procedure. If a Party intends to claim
indemnification under this Agreement (the “Indemnitee”), it shall promptly
notify the other Party (the “Indemnitor”) in writing of such alleged Loss and
the Third Party Claim. The Indemnitor shall have the right to control the
defense thereof with counsel of its choice as long as such counsel is reasonably
acceptable to Indemnitee. Any Indemnitee shall have the right to retain its own
counsel at its own expense for any reason in connection with such Third Party
Claim, provided, however, that if the Indemnitee shall have reasonably
concluded, based upon a written opinion from outside legal counsel, that there
is a conflict of interest between the Indemnitor and the Indemnitee in the
defense of such action, the Indemnitor shall pay the fees and expenses of one
law firm serving as counsel for the Indemnitee in relation to such Third Party
Claim. The Indemnitee, its employees and agents, shall reasonably cooperate with
the Indemnitor and its legal representatives in the investigation of any Third
Party Claims covered by this Agreement. The obligations of this Article 15 shall
not apply to any settlement of any Third Party Claims if such settlement is
effected without the consent of both Parties, which shall not be unreasonably
withheld or delayed. The failure to deliver written notice to the Indemnitor
within a reasonable time after the commencement of any such action, to the
extent prejudicial to its ability to defend such action, shall relieve the
Indemnitor of any obligation to the Indemnitee under this Clause 15.3. It is
understood that only Noile-Immune and Adaptimmune may claim indemnity under this
Agreement (on its own behalf or on behalf of its Indemnitees), and other
Indemnitees may not directly claim indemnity hereunder.     15.4 Insurance.    
  15.4.1 Insurance Coverage. Each Party shall obtain and maintain comprehensive
general liability insurance customary in the industry for companies of similar
size conducting similar business.         15.4.2 Evidence of Insurance. No
earlier than thirty (30) days after signing this Agreement, each Party shall
provide, upon request therefor, the other Party with its certificate of
insurance evidencing the insurance coverage set forth Clause 15.4.1.       15.5
Limitation of Damages. NEITHER PARTY HERETO WILL BE LIABLE FOR INDIRECT,
INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, OR PUNITIVE DAMAGES, INCLUDING
LOST PROFITS, ARISING FROM OR RELATING TO THIS AGREEMENT, REGARDLESS OF ANY
NOTICE OF SUCH DAMAGES, except in respect of any breach of (1) a Party’s
obligations under Article 11 or 12, or (2) indemnification obligations under
THIS Article 15 for third party claims. FOR THE AVOIDANCE OF DOUBT, NOTHING IN
THIS CLAUSE SHALL LIMIT OR EXCLUDE ANY LIABILITY TO A THIRD PARTY FOR FRAUD BY
ANY PARTY OR ANY LIABILITY ARISING AS A RESULT OF PERSONAL INJURY OR DEATH
CAUSED BY NEGLIGENCE OF ANY PARTY. NOTHING IN THIS CLAUSE 15.5 SHALL LIMIT
EITHER PARTY’S RIGHT TO PURSUE AND OBTAIN EQUITABLE RELIEF.

 

  Page 28

 

 

15.6Product Recall. Adaptimmune shall be responsible for investigating any SUSAR
or other complaint in relation to any Product. Adaptimmune shall be responsible
for carrying out any Product recall but shall keep the JSC, as relevant,
informed of the status and process for such recall including any material
correspondence with any Regulatory Authority. The costs associated with any
recall of any Product shall be borne by Adaptimmune.

 

16.            TERM AND TERMINATION

  

16.1Term. The term of this Agreement (the “Term”) shall commence on the
Effective Date and, unless sooner terminated as provided in this Article 16
shall continue in full force and effect, on a country-by-country and
Product-by-Product basis until such Product ceases being commercialized or
further developed by Adaptimmune, at which time this Agreement shall expire with
respect to such Product in such country (except for such provisions of this
Agreement as continue beyond its natural expiration). The Term shall expire on
the date this Agreement has expired in its entirety with respect to all Products
in all countries in the world.

 

16.2Termination by Either Party for Material Breach. Either Party may terminate
this Agreement (i) in its entirety, (ii) with respect to any Exclusive License
granted by such Party, (iii) with respect to a given Nominated Target, or (iv)
on a country-by-country basis, by written notice delivered to the other Party
for any material breach of this Agreement by the other Party if, in the case of
remediable breach, such material breach is not cured within [***] days [***]
after the breaching Party receives written notice of such breach from the
non-breaching Party describing such breach and demanding its cure; provided,
that if such breach is not capable of being cured within such [***]-day [***]
period, the cure period shall be extended for such amount of time that the
Parties may agree in writing is reasonably necessary to cure such breach, so
long as (1) the breaching Party is making Commercially Reasonable Efforts to do
so, and (2) the Parties agree on an extension within such [***]-day [***]
period. For clarity, this Agreement may be terminated in its entirety under this
Clause 16.2 only if the material breach affects the fundamental purpose of this
Agreement. Notwithstanding anything to the contrary herein, if the allegedly
breaching Party in good faith either disputes (a) whether a breach is material
or has occurred or (b) the alleged failure to cure or remedy such material
breach, and provides written notice of that dispute to the other Party within
the above time periods, then the matter will be addressed under the dispute
resolution provisions in Article 17 and the notifying Party may not so terminate
this Agreement until it has been determined under Article 17 that the allegedly
breaching Party is in material breach of this Agreement, and such breaching
Party further fails to cure such breach within [***]-days (or such longer period
as determined by the arbiter of such dispute resolution) after the conclusion of
that dispute resolution procedure.

 

16.3Termination by Either Party for Insolvency or Bankruptcy. Either Party may
terminate this Agreement effective ten (10) business days after delivery of
written notice to the other Party upon the liquidation, dissolution, winding-up,
insolvency, bankruptcy, or filing of any petition therefor, appointment of a
receiver, custodian or trustee, or any other similar proceeding, by or of the
other Party where such petition, appointment or similar proceeding is not
dismissed or vacated within ninety (90) calendar days. All rights and licenses
granted pursuant to this Agreement are, for purposes of Clause 365(n) of Title
11 of the United States Code or any foreign equivalents thereof (as used in this
Clause 20.3, “Title 11”), licenses of rights to “intellectual property” as
defined in Title 11. Each Party in its capacity as a licensor hereunder agrees
that, in the event of the commencement of bankruptcy proceedings by or against
such bankrupt Party under Title 11, (a) the other Party, in its capacity as a
licensee of rights under this Agreement, shall retain and may fully exercise all
of such licensed rights under this Agreement (including as provided in this
Clause 16.3) and all of its rights and elections under Title 11, and (b) the
other (licensee) Party shall be entitled to a complete duplicate of all
embodiments of such intellectual property, and such embodiments, if not already
in its possession, shall be promptly delivered to the other (licensee) Party (i)
upon any such commencement of a bankruptcy proceeding, unless the bankrupt Party
elects to continue to perform all of its obligations under this Agreement, or
(ii) if not delivered under (i), immediately upon the rejection of this
Agreement by or on behalf of the bankrupt Party.

 

  Page 29

 

  

16.4[***].

 

16.5Termination by Noile-Immune.

 

16.5.1Noile-Immune may terminate any Exclusive License granted to Adaptimmune,
on provision of 30 days written notice to Adaptimmune, in the event that [***]

 

16.5.2[***]

  

16.6Termination by either Party for Patent challenge: Either Party may terminate
any Exclusive License under which a license has been granted to the other Party
to use any of such Party’s Licensed Intellectual Property, if the other Party or
its Affiliates commences proceedings (whether before a regulatory or
administrative body or a court) anywhere in the world, or voluntarily assists
any Third Party in commencing or participating in such proceedings (whether
before a regulatory or administrative body or a court) alleging that any claim
in any Patent within such Licensed Intellectual Property that is licensed to the
other Party by such Party (including the Adaptimmune Background IP or
Noile-Immune Background IP, as applicable) is invalid, unenforceable or
otherwise not patentable, and such proceedings are not withdrawn within thirty
(30) days after receipt of a written notice to withdraw. Notwithstanding the
foregoing, a license-granting Party shall have no right to terminate any
Exclusive License pursuant to this Clause 16.6 if any proceedings are brought as
a defense (including an affirmative defense) in relation to a claim of
infringement brought against the other Party or its Affiliates.

 

16.7Accrued Rights and Obligations. Expiration or termination of this Agreement
in its entirety, or with respect to a particular Exclusive License, a given
Product, or a given country for any reason, shall not release either Party
hereto from any liability which, as of the effective date of such expiration or
termination, had already accrued to the other Party or which is attributable to
a period prior to such termination, nor preclude either Party from pursuing any
rights and remedies it may have hereunder or at law or in equity which accrued
or are based upon any event occurring prior to the effective date of such
expiration or termination.

 

16.8Effects of Termination. The effects of termination set forth in this Clause
16.8 shall apply either with respect to this Agreement in its entirety, if the
Agreement is terminated in its entirety, or only with respect to a specific
Product or Exclusive License or country, if this Agreement is only terminated
with respect to a specific Product, or Exclusive License or country, in all
cases as applicable.

 

16.8.1Termination of Licenses.

 

    (a)      Upon termination of the Agreement in its entirety by either Party,
all licenses and options granted under this Agreement shall terminate as of the
effective date of such termination save as explicitly otherwise provided to
survive termination of this Agreement. Performance of all Research Plans shall
cease as of effective date of termination.

 

    (b)      Upon termination of any Exclusive License by either Party, such
Exclusive License and any associated Development License shall terminate as of
the effective date of such termination save as explicitly otherwise provided to
survive termination of this Agreement. All other Exclusive Licenses and
Development Licenses and the remaining terms of this Agreement shall continue in
full force and effect following such termination. Performance of the Research
Plan for the Nominated Target subject to the Exclusive License shall cease as of
the effective date of termination.

 

    (c)      Upon termination of this Agreement in relation to any Product or to
any country, the Exclusive License and any Development License shall only
terminate in relation to such Product or to such country (save as explicitly
otherwise provided to survive termination) and shall otherwise remain in full
force and effect. Any Research Plan for the development of the Product subject
to termination shall cease as of the effective date of termination.

 

  Page 30

 

  

    (d)      Upon termination of this Agreement by either Party, the provisions
of Clause 3.2.1 shall cease to apply. On termination of any Exclusive License by
either Party, the provisions of Clause 3.2.1 shall cease to apply in relation to
the Nominated Target relevant to such Exclusive License.

  

16.8.2Clinical Trials. The Parties shall ensure that where termination of any
Exclusive License or this Agreement occurs during any Clinical Trial or after
the filing of any application to any Regulatory Authority for any Clinical
trial, that any such Clinical Trial shall be wound down in accordance with the
protocol for such Clinical Trial and in such a way as to minimize any patient
harm and at all times in accordance with all Applicable Laws.

 

16.8.3Return of Confidential Information. Following expiry or any early
termination of this Agreement, the Party that has Confidential Information of
the other Party shall to the extent reasonably possible destroy (at such Party’s
written request) or put beyond use all such Confidential Information in its
possession as of the effective date of expiration or termination (with the
exception of one copy of such Confidential Information, which may be retained by
the legal department of the Party that received such Confidential Information
solely for purposes of ensuring compliance with confidentiality obligations),
provided that each Party may retain and continue to use such Confidential
Information of the other Party to the extent necessary to exercise any surviving
rights, licenses or obligations under this Agreement or any obligation under
Applicable Laws. This clause shall not require return or destruction of any
Confidential Information which is held on back-up servers or archive systems,
provided such back-ups have been made as part of the routine business of a Party
and such back-ups are not accessible other than by members of the IT team at
such Party. Any retained Confidential Information will continue to be subject to
the confidentiality provisions of this Agreement.

 

16.8.4Inventory at Termination. [***]

 

16.9Survival. In addition to any provisions specified in this Agreement as
surviving under the applicable circumstances, the following provisions shall
survive: Articles 1 (to the extent required for interpretation), 5, 10 (to the
extent any ongoing payment obligations survive), 14, 15, 16, 17, and Clauses
11.1.2, 12.1 – 12.5 (inclusive), 13.2, 20.1 – 20.11. In addition to those
provisions specifically referenced in this Clause 16.9, those provisions which
by their nature are intended to survive, as well as any other provisions
necessary to interpret or implement any other surviving provisions (including,
to the extent applicable, the definitions in Article 1), shall survive.

 

17.            DISPUTE RESOLUTION

  

17.1Disputes. Adaptimmune and Noile-Immune recognize that a dispute, controversy
or claim of any nature whatsoever arising out of or relating to this Agreement,
or the breach, termination or invalidity thereof (each, a “Dispute”), may from
time to time arise during the Term. Unless otherwise specifically recited in
this Agreement (for example in relation to decision making of the JSC or JDC),
such Disputes between Adaptimmune and Noile-Immune will be resolved as set out
in this Article 17. In the event of the occurrence of such a Dispute, the
Parties shall first refer such Dispute to their respective Alliance Managers for
attempted resolution by such Alliance Managers within thirty (30) days after
such referral. If such Dispute is not resolved within such thirty (30) day
period, either Adaptimmune or Noile-Immune may, by written notice to the other,
have such Dispute referred to their respective officers designated below, or
their respective designees, for attempted resolution within thirty (30) days
after such notice is received. Such designated officers are as follows:

 

  Page 31

 

 

 For Noile-Immune – [***]     For Adaptimmune – [***]     In the event the
designated officers, or their respective designees, are not able to resolve such
Dispute, and if resolution of such Dispute is not explicitly provided for herein
through any other means, then within thirty (30) days of such other Party’s
receipt of such written notice, either Party may initiate the dispute resolution
procedures set forth in Clause 17.2.

  

17.2Arbitration.

 

17.2.1Rules. Except as otherwise expressly provided in this Agreement (including
under Clause 17.3 with respect to Patent-related matters), the Parties agree
that any Dispute not resolved internally by the Parties pursuant to Clause 17.1
shall be resolved through binding arbitration conducted by the International
Chamber of Commerce in accordance with the then prevailing Rules of Arbitration
of the International Chamber of Commerce (for purposes of this Article 17, the
“Rules”), except as specifically modified in this Agreement, applying the
substantive law specified in Clause 20.1.

 

17.2.2Arbitrators; Location. Each Party shall select one (1) arbitrator, and the
two (2) arbitrators so selected shall choose a third arbitrator. All three (3)
arbitrators shall serve as independent arbitrators and have at least ten (10)
years of (a) dispute resolution experience (including judicial experience)
and/or (b) legal or business experience in the biotech or pharmaceutical
industry. In any event, at least one (1) arbitrator shall satisfy the foregoing
experience requirement under Clause (b). If a Party fails to nominate its
arbitrator, or if the Parties’ arbitrators cannot agree on the third, the
necessary appointments shall be made in accordance with the Rules. Once
appointed by a Party, such Party shall have no ex parte communication with its
appointed arbitrator. The arbitration proceedings shall be conducted in New
York. The arbitration proceedings and all pleadings and written evidence shall
be in the English language. Any written evidence originally in another language
shall be translated into English and accompanied by the original or a true copy
thereof.

 

17.2.3Procedures; Awards. Each Party agrees to use reasonable efforts to make
all of its current employees available to the arbitrators, if reasonably needed,
and agrees that the arbitrators may determine any person as necessary. The
arbitrators shall be instructed and required to render a written, binding,
non-appealable resolution and award on each issue that clearly states the basis
upon which such resolution and award is made. The written resolution and award
shall be delivered to the Parties as expeditiously as possible, but in no event
more than ninety (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,
notwithstanding any provision of Applicable Law or of this Agreement, it will
not request, and the arbitrators shall have no authority to award, punitive or
exemplary damages against any Party. All information disclosed and generated in
the course of such arbitration proceeding shall be treated as confidential
information by each of the Parties.

 

17.2.4Costs. The prevailing Party, as determined by the arbitrators, shall be
entitled to (a) its share of fees and expenses of the arbitrators and (b) its
reasonable attorneys’ fees and associated costs and expenses. In determining
which Party “prevailed,” the arbitrators shall consider (i) the significance,
including the financial impact, of the claims prevailed upon and (ii) the scope
of claims prevailed upon, in comparison to the total scope of the claims at
issue. If the arbitrators determine that, given the scope of the arbitration,
neither Party “prevailed,” the arbitrators shall order that the Parties (1)
share equally the fees and expenses of the arbitrators and (2) bear their own
attorneys’ fees and associated costs and expenses.

 

  Page 32

 

  

17.2.5Interim Equitable Relief. Notwithstanding anything to the contrary in this
Clause 17.2, in the event that a Party reasonably requires relief on a more
expedited basis than would be possible pursuant to the procedure set forth in
this Article 17, such Party may seek a temporary injunction or other interim
equitable relief in a court of competent jurisdiction pending the ability of the
arbitrators to review the decision under this Clause 17.2. Such court shall have
no jurisdiction or ability to resolve Disputes beyond the specific issue of
temporary injunction or other interim equitable relief.

 

17.2.6Protective Orders; Arbitrability. At the request of either Party, the
arbitrators shall enter an appropriate protective order to maintain the
confidentiality of information produced or exchanged in the course of the
arbitration proceedings. The arbitrators shall have the power to decide all
questions of arbitrability.

 

17.3Subject Matter Exclusions. Notwithstanding the provisions of Clause 17.2,
any Dispute not resolved internally by the Parties pursuant to Clause 17.1 that
involves the validity or infringement of a Patent shall be brought before an
appropriate regulatory or administrative body in the country in which such
Patent is granted or applied for, and the Parties hereby consent to the
jurisdiction and venue of such courts and bodies.

 

17.4Continued Performance. Provided that this Agreement has not terminated, the
Parties agree to continue performing under this Agreement in accordance with its
provisions, pending the final resolution of any Dispute.

 

18.            ANTI-BRIBERY

  

18.1Anti-Bribery.

 

 

18.1.1“Anti-Corruption Laws” means all anti-corruption and anti-bribery laws and
regulations, including the U.S. Foreign Corrupt Practices Act of 1977, as
amended, and the United Kingdom Bribery Act 2010, as amended, and any other
applicable anti-corruption laws and laws for the prevention of fraud,
racketeering, money laundering or terrorism.

 

18.1.2“Government Official” means any person employed by or acting on behalf of
a government, government-controlled entity or public international organization;
any political party, party official or candidate; any person who holds or
performs the duties of an appointment, office or position created by custom or
convention; and any person who holds himself out to be the authorised
intermediary of any of the foregoing.

 

18.1.3The Parties agree, on behalf of themselves and their respective officers,
directors and employees, that in connection with this Agreement, it shall not
directly or indirectly pay, offer or promise to pay, or authorise the payment of
any money, or give, offer or promise to give, or authorise the giving of
anything else of value, to (i) any Government Official in order to influence
official action; (ii) any person (whether or not a Government Official) (a) to
influence such person to act in breach of a duty of good faith, impartiality or
trust, (b) to reward such person for acting improperly, or (c) where such person
would be acting improperly by receiving the money or other thing of value; (iii)
any other person while knowing or having reason to know that all or any portion
of the money or other thing of value will be paid, offered, promised or given
to, or will otherwise benefit a Government Official in order to influence
official action for or against any party in connection with the matters that are
the subject of this agreement; or (iv) any person to reward that person for
acting improperly or to induce that person to act improperly.

 

18.1.4The Parties agree, on behalf of themselves and their respective officers,
directors and employees that work in connection with this Agreement that they
shall not, directly or indirectly, solicit, receive or agree to accept any
payment of money or anything else of value in violation of the Anti-Corruption
Laws. In connection with the performance of the services hereunder, the Parties
undertake to comply with the Anti-Corruption Laws and shall not take any action
that will, or would reasonably be expected to, cause it to be in violation of
any such laws to the extent applicable to either Party.

 

  Page 33

 

 

18.1.5Each Party shall promptly provide the other Party with written notice of
(i) becoming aware of any breach or violation by the relevant Party or its
sub-contractors or its or their respective officers, directors, employees, of
any of the representation, warranty or undertaking set forth in this Clause 18.1
or (ii) upon receiving a formal notification that it is the target of a formal
investigation by any governmental authority for any breach of Anti-Corruption
Laws in connection with the performance of this Agreement.

 

19.            DATA PROTECTION

  

19.1The Parties agree to comply with all applicable national and international
laws, regulations and guidelines relating to the protection and processing of
personal data and person identifiable information and as further set out in
Exhibit 3.

 

20.            MISCELLANEOUS

 

20.1Applicable Law. This Agreement (including the arbitration provisions of
Article 18) shall be governed by and interpreted in accordance with the laws of
New York, without reference to the principles of conflicts of laws. The United
Nations Convention on Contracts for the International Sale of Goods shall not
apply to the transactions contemplated by this Agreement.

 

20.2Notices. Except as otherwise expressly provided in the Agreement, any notice
required under this Agreement shall be in writing and shall specifically refer
to this Agreement. Notices shall be sent via one of the following means and will
be effective (a) on the date of delivery, if delivered in person; or (b) on the
date of receipt, if sent by private express courier or by first class certified
mail, return receipt requested. Notices shall be sent to the other Party at the
addresses set forth below. Either Party may change its addresses for purposes of
this Clause 20.2 by sending written notice to the other Party.

 

 If to Noile-Immune:         Noile-Immune Biotech, Inc.
                                          [***]     If to Adaptimmune:
        Adaptimmune Limited
                                           [***]

 

20.3Assignment. Neither Party may assign or otherwise transfer, in whole or in
part, this Agreement without the prior written consent of the non-assigning
Party, such approval not to be unreasonably withheld, conditioned or delayed.
Notwithstanding the foregoing, either Party may assign this Agreement to (i) an
Affiliate or (ii) any purchaser of all or substantially all of the assets of
such Party that relate to the performance of this Agreement, or of all of its
capital stock, or to any successor corporation or entity resulting from any
merger or consolidation or re-organization of such party with or into such
corporation or entity, provided that the Party to which this Agreement is
assigned expressly agrees in writing to assume and be bound by all obligations
of the assigning Party under this Agreement. Subject to the foregoing, this
Agreement will benefit and bind the Parties’ successors and permitted assigns.
Any assignment not in accordance with this Clause 20.3 shall be null and void.

 

20.4Independent Contractors. The Parties hereto are independent contractors and
nothing contained in this Agreement shall be deemed or construed to create a
partnership, joint venture, employment, franchise, agency or fiduciary
relationship between the Parties.

 

  Page 34

 

 

20.5Entire Agreement. Except to the extent expressly provided herein, this
Agreement constitutes the entire agreement between the Parties relating to the
subject matter of this Agreement and supersedes all previous oral and written
communications between the Parties with respect to the subject matter of this
Agreement. Both Parties confirm that in entering into this Agreement that have
not relied on any representation or statement from the other Party that is not
explicitly stated as a warranty or representation under this Agreement. Nothing
in this Clause 20.5 shall exclude any liability for fraud or fraudulent
misrepresentation or exclude any remedy for such.

 

20.6Amendment; Waiver. Except as otherwise expressly provided herein, no
alteration of or modification to this Agreement shall be effective unless made
in writing and executed by an authorised representative of both Parties. No
course of dealing or failing of either Party to strictly enforce any term, right
or condition of this Agreement in any instance shall be construed as a general
waiver or relinquishment of such term, right or condition. The observance of any
provision of this Agreement may be waived (either generally or any given
instance and either retroactively or prospectively) only with the written
consent of the Party granting such waiver.

 

20.7Further Assurance. Each Party shall and shall use all Commercially
Reasonable Efforts to procure that any necessary Third Party shall promptly
execute and deliver such further documents and do such further acts as may be
required for the purpose of giving full effect to this Agreement.

 

20.8Severability. The Parties do not intend to violate any public policy or
statutory or common law. However, if any sentence, paragraph, section, clause or
combination or part thereof of this Agreement is in violation of any law or is
found to be otherwise unenforceable, such sentence, paragraph, section, clause
or combination or part of the same shall be deleted and the remainder of this
Agreement shall remain binding, provided that such deletion does not alter the
basic purpose and structure of this Agreement.

 

20.9No Third Party Rights. The Parties do not intend that any term of this
Agreement should be enforceable by any person who is not a Party.

 

20.10Interpretation. The captions and headings to this Agreement are for
convenience only, and are to be of no force or effect in construing or
interpreting any of the provisions of this Agreement. Unless context otherwise
clearly requires, whenever used in this Agreement: (a) the words “include” or
“including” shall be construed as incorporating “but not limited to” or “without
limitation”; (b) the words “hereof,” “herein,” “hereby” and derivative or
similar words refer to this Agreement, including the Exhibits; (c) the word
“law” or “laws” means any applicable, legally binding statute, ordinance,
resolution, regulation, code, guideline, rule, order, decree, judgment,
injunction, mandate or other legally binding requirement of a governmental
authority (including a court, tribunal, agency, legislative body or other
instrumentality of any (i) government or country or territory, (ii) any state,
province, county, city or other political subdivision thereof, or (iii) any
supranational body); (d) all references to the word “will” are interchangeable
with the word “shall” and shall be understood to be imperative or mandatory in
nature; (f) the singular shall include the plural and vice versa; and (g) the
word “or” has the inclusive meaning represented by the phrase “and/or”. All
references to days, months, quarters or years are references to calendar days,
calendar months, calendar quarters, or calendar years.

 

20.11Other Activities. The Parties acknowledge that each of them may now or in
the future engage in research, manufacturing, development or commercialisation
activities that utilize technologies similar to or involve therapies or
pharmaceutical products competitive with those contemplated by this Agreement.
Neither Party shall be prevented from using any publicly available research
results or other information (including any publicly available information of
the other Party) to the same extent as Third Parties generally are legally
permitted to do so. Each Party agrees to inform its key personnel assigned to
perform activities hereunder of the limitations on use of Confidential
Information contained in this Agreement, instruct such personnel to comply with
such restrictions, and where appropriate, impose firewalls or other appropriate
measures to minimize the potential for misuse of information. However, each
Party has limited resources, and as a result it is anticipated that personnel
assigned to activities hereunder may also participate in other activities that
may utilize technologies similar to or involve therapies or pharmaceutical
products competitive with those contemplated by this Agreement. In particular,
it is anticipated that personnel in sales, marketing, clinical and regulatory
functions, regardless of level, will participate in multiple programs and that
management personnel will by nature of their leadership positions participate in
multiple programs.

 

  Page 35

 

 

20.12Counterparts. This Agreement may be executed in two or more counterparts,
each of which will be deemed an original, but all of which together will
constitute one and the same instrument. For purposes hereof, a facsimile copy,
or email with attached pdf copy, of this Agreement, including the signature
pages hereto, will be deemed to be an original.

 

[Signature page follows – the rest of this page intentionally left blank.]

 

  Page 36

 

  

IN WITNESS WHEREOF, duly authorised representatives of the Parties have executed
this Agreement as of the Effective Date.

 

ADAPTIMMUNE LIMITED       By: /s William Bertrand       Name: William Bertrand  
    Title: Chief Operating Officer           NOILE-IMMUNE BIOTECH, INC.      
By: /s Hidenobu Ishizaki       Name: Hidenobu Ishizaki       Title: President
and CEO  

 

  Page 37

 

  

 

EXHIBIT 1 – Initial Research Plan

 

THIS PAGE AND THE FOLLOWING 5 PAGES OF THIS EXHIBIT HAVE BEEN OMITTED because
THEY ARE both (i) not material and (ii) would be competitively harmful if
publicly disclosed

 

[***]

 

 

 

 

EXHIBIT 2 – Payments

 

Upfront Payments

 

Upfront Payment for grant of Exclusive License for First Target

 

·In consideration of the grant of the Exclusive License in relation to the first
Target, Adaptimmune will pay an upfront sum of US$2.5M (two million five hundred
thousand US dollars).

 

·Payment will be due following Effective Date and within 45 days of receipt by
Adaptimmune of a valid invoice from Noile-Immune requesting payment of such
amount.

 

Upfront Payments due on acceptance of Target Nominations for [***] Targets

 

·[***]

 

·[***]

 

·[***]

 

·Payment of upfront payments for all Target Nominations other than the first
Target Nomination, shall be due following Acceptance Date and within 45 days of
receipt of a valid invoice from Noile-Immune requesting payment of such amounts.

 

Total upfront payments

 

Except for pursuant to Section 16.5.2, the total upfront payments payable by
Adaptimmune under this Exhibit 2 will not exceed [***].

 

Procedural Milestones

 

The following Procedural Milestones shall be payable by Adaptimmune to
Noile-Immune in accordance with clause 9.3 of this Agreement.

 

Procedural Milestone Event Procedural Milestone
payable for first Product
developed by
Adaptimmune to first
Target [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
[***] [***] [***] [***] [***] [***] [***]

 

·[***]

 

·[***]

 

·[***]

 

·Procedural Milestones are payable in US dollars.

 

 

 

 

Sales Milestones

 

Where the aggregate Net Sales of any Product (or Products) for a Nominated
Target equal or exceed [***] (“Sales Milestone Event”), Adaptimmune will pay a
one-time sales milestone of [***] (“Sales Milestone”) in relation to such
Nominated Target. 

 

·Sales Milestones are only paid once for any Nominated Target, for the first
time the aggregate Net Sales of all Product (or Products) for such Nominated
Target achieve the Sales Milestone Event in any Year; ·Total Sales Milestones
payable under this Agreement by Adaptimmune will not exceed [***] (i.e. one
Sales Milestone for each Nominated Target).  ·Sales Milestones are payable in US
dollars.

 

 

 

 

EXHIBIT 3 – DATA PROTECTION

 

1.1In this Exhibit:

 

(a)Adaptimmune is the Controller and Noile-Immune is the Processor; and

 

(b)the types of Personal Data and categories of Data Subject which will be
processed, the nature and purpose of that processing and the duration of that
processing are as set out below:

 

(i)Personal Data capable of identifying any of Controller’s employees,
contractors or other individuals working for or on behalf of Controller.

 

(c)Data Protection Legislation in this Exhibit refers to all applicable privacy
and data protection laws including the General Data Protection Legislation ((EU)
2016/679) (GDPR) and any applicable national implementing laws, regulations and
secondary legislation in England and Wales relating to the processing of
personal data  and the privacy of electronic communications, as amended,
replaced or updated from time to time, including the Privacy and Electronic
Communications (EC Directive) Regulations 2003 (SI 2003/2426) (Privacy
Regulations) as amended by the Privacy and Electronic Communications (EC
Directive) (Amendment) Regulations 2011 (SI 2011/1208), the Privacy and
Electronic Communications (EC Directive) (Amendment) Regulations 2015 (SI
2015/355) and the Privacy and Electronic Communications (EC Directive)
(Amendment) Regulations 2016 (SI 2016/524).

 

(d)Personal Data and Data Subject shall have the meanings given to them under
the Data Protection Legislation.

 

1.2In relation to the processing of Personal Data, Processor shall:

 

(a)only process Personal Data in accordance with the Controller's written
instructions from time to time (which may be specific instructions or standing
instructions of general application in relation to the performance of a Research
Plan or this Agreement, whether set out in this Agreement or otherwise notified
to the Processor, unless such processing is required by any law (other than
contract law) to which the Processor is subject, in which case the Processor
shall (to the extent permitted by law) inform the Controller of that legal
requirement before carrying out the processing;

 

(b)immediately notify the Controller if it considers that the Controller's
instructions are in breach of the GDPR or other EU member state laws; and

 

(c)keep a written record of all such processing activities.

 

1.3In relation to the security and confidentiality of the Personal Data,
Processor shall:

 

(a)ensure that it has in place appropriate technical and organisational measures
to ensure a level of security for the Personal Data which is appropriate to the
risks to individuals that may result from the accidental or unlawful
destruction, loss, alteration, unauthorised disclosure of, or access to the
Personal Data;

 

 

 

 

(b)in addition to the confidentiality obligations in Article 12 of this
Agreement:

 

(i)ensure that only those of the Processor's personnel who need to have access
to the Personal Data are granted access to such data and only for the purposes
of the performance of this Agreement and all of the Processor's personnel
required to access the Personal Data are informed of the confidential nature of
the Personal Data, comply with the obligations set out in this Exhibit, and are
bound by appropriate confidentiality obligations when accessing the Personal
Data; and

 

(ii)not publish, disclose or divulge any of the Personal Data to any third party
(including for the avoidance of doubt the Data Subject itself) unless directed
to do so in writing by the Controller;

 

(c)not modify, amend or alter the contents of the Personal Data unless
specifically authorised in writing by the Controller.

 

1.4If the Processor becomes aware of a Personal Data breach, it shall notify the
Controller without undue delay on becoming of aware of such a breach.

 

1.5The Processor shall notify the Controller within five Business Days upon
receiving the following:

 

(a)a request from a Data Subject to have access to that person's Personal Data;
or

 

(b)a complaint or request relating to the Controller's obligations under the
Data Protection Legislation; or

 

(c)any other communication relating directly or indirectly to the processing of
any Personal Data in connection with this Agreement.

 

1.6The Processor shall provide the Controller with full co-operation and
assistance in order to enable the Controller to comply with its obligations
under the Data Protection Legislation in relation to:

 

(a)the Controller's obligations in relation to responding to Data Subject
requests;

 

(b)the security of the Personal Data;

 

(c)notifying Personal Data breaches to the relevant supervisory authority;

 

(d)communicating personal data breaches to the Data Subject; and

 

(e)impact assessments and related consultations with supervisory authorities or
regulators.

 

1.7The Processor shall:

 

(a)make available to the Controller all information that the Controller requests
from time to time to enable the Controller to verify that the Processor is in
compliance with its obligations in this Exhibit; and

 

(b)permit the Controller or its external advisers to inspect and audit the
Processor's data processing activities and those of its agents, subsidiaries and
Sub-contractors (to the extent the Processor is reasonably able to procure such
third party access).

 

 

 

 

1.8The Processor shall not engage or authorise a sub-contractor to process the
Personal Data unless:

 

(i)it has obtained the prior written consent of the Controller (which may be
granted or withheld in the Controller's sole discretion) before transferring the
Personal Data to any Sub-Contractors in connection with the provision of the
Services; and

 

(ii)the Sub-Contractor has either entered into a direct contract with the
Controller or a contract with the Processor which incorporates the provisions
equivalent to those in this agreement in relation to confidentiality, data
protection and security

 

1.9In relation to transfers of Personal Data to areas outside the European
Economic Area (EEA) in addition to initial transfer of Personal Data from
Controller to Processor:

 

(a)the Processor shall not transfer any Personal Data outside the EEA without
the Controller's prior written consent; and

 

(b)if the Controller consents to any transfers pursuant to preceding clause, the
Processor shall ensure that the following conditions are met in relation to such
transfers:

 

(i)the Processor complies with its obligations under the Data Protection
Legislation by ensuring that there is an adequate level of protection to any
Personal Data that is transferred (including as relevant model clauses or
adoption of Privacy Shield as appropriate);

 

(ii)that there are appropriate safeguards in place in relation to that transfer;

 

(iii)that Data Subjects have enforceable rights and effective legal remedies;
and

 

(iv)that the Processor shall comply with any other reasonable instructions as
notified to it by the Controller in relation to such transfers.

 

1.10The Controller acknowledges that the Processor is reliant on the Controller
alone for direction as to the extent the Processor is entitled to use and
process the Personal Data. The Processor shall be entitled to relief from
liability in circumstances where a Data Subject makes a claim or complaint with
regards to the Processor's actions to the extent that such actions directly
result from instructions received from the Controller.

 

1.11On the expiry or termination of this Agreement, the Processor shall notify
the Controller of the Personal Data that it holds. Promptly following such
expiry or termination, and unless otherwise instructed in writing by Controller
or continued storage is required by the Processor to comply with Applicable
Laws, the Processor shall securely and permanently destroy all copies of
Personal Data in its possession or control (other than any copy transferred to
the Controller in accordance with Controller’s request).

 

1.12The Processor shall, at all times during and after the term of this
Agreement, indemnify the Controller and keep the Controller indemnified against
all losses, damages, costs or expenses and other liabilities (including legal
fees) incurred by, awarded against or agreed to be paid by the Controller
arising from any breach of the Processor's obligations under this Exhibit except
and to the extent that such liabilities have resulted directly from the
Controller's instructions.

 

 

 

 

EXHIBIT 4 – GOVERNANCE

 

1.Joint Steering Committee.

 

1.1Formation and Composition. As soon as reasonably possible and in any event
within thirty (30) days after the Effective Date, Adaptimmune and Noile-Immune
shall establish a joint steering committee (the “JSC”) to monitor and coordinate
the communication and activities of both Parties under this Agreement. The JSC
shall be composed of at least three (3) but no more than four (4)
representatives designated by each Party and in each case an equal number of
representatives from each Party. Representatives must be appropriate for the
tasks then being undertaken and the stage of development or commercialisation
applicable, in terms of their seniority, decision-making authority,
availability, function in their respective organizations, training and
experience. Each Party may replace its JSC representatives from time to time
upon written notice to the other Party; provided, however, if a Party’s JSC
representative is unable to attend a JSC meeting, such Party may designate an
alternate to attend such JSC meeting by providing notification in writing to the
other Party’s Alliance Manager and following provision of such written
notification the alternate will be entitled to perform the functions of such JSC
representative at such JSC meeting. The Alliance Managers may attend meetings of
the JSC but shall have no right to vote on any decisions of the JSC.

 

1.2JSC Responsibilities. In addition to its overall responsibility for
monitoring the activities of the Parties under this Agreement, the JSC shall, in
particular:

 

(a)work to resolve, through good faith discussions, any dispute, controversy or
claim between the Parties arising during the performance of any Research Plan
and related to the matters under the authority of the JSC;

 

(b)review and approve any material amendments to any Research Plan proposed by
the applicable JPT;

 

(c)review and approve any criteria (and amendments to such criteria) for
development of any Product under any Research Plan including criteria required
for any Product to proceed to the next phase of development under any Research
Plan;

 

(d)perform such other functions as may be agreed to by the Parties in writing
(or as specified in this Agreement.

 

Decision making for JSC. Each Party will discuss and attempt to resolve any
potential or evolving disagreement through its respective Alliance Managers
and/or the applicable JPT before it is brought before the JSC for resolution.
With respect to the responsibilities of the JSC, each Party shall have one vote
on all matters brought before the JSC. The JSC shall operate as to matters
within its responsibility by unanimous vote. Each Party shall make decisions in
good faith and shall not take any decisions which would unreasonably delay the
performance of any Research Plan. [***]

 

1.3Any JSC decisions, any decisions of the Party’s senior managers [***] under
Paragraph 1.3 above are subject to the following: (i) neither the JSC, the
senior managers [***] shall have the unilateral or overriding authority to amend
or modify, or waive a Party’s own compliance with, this Agreement including in
relation to the scope or terms of any license to Intellectual Property Rights;
and (ii) neither the JSC, the senior managers [***] will have the unilateral or
overriding authority to amend any Research Plan in a way which would materially
increase the cost for the other Party or materially increase the resources
required from the other Party.

 

 

 

  

2.Joint Development Committee.

 

2.1Formation and Composition. As soon as reasonably possible after Acceptance
Date for any Target, Adaptimmune and Noile-Immune shall establish a joint
development committee (the “JPT”) to monitor and coordinate the communication
and activities of both Parties under the applicable Research Plan for the
Nominated Target. The JPT shall be composed of at least two (2) but no more than
three (3) representatives designated by each Party and in each case an equal
number of representatives from each Party. Representatives must be appropriate
for the tasks then being undertaken and the applicable stage of research, in
terms of their seniority, decision-making authority, availability, function in
their respective organisations, training and experience. Each Party may replace
its JPT representatives from time to time upon written notice to the Alliance
Manager of the other Party; provided, however, if a Party’s JPT representative
is unable to attend a JPT meeting, such Party may designate an alternate to
attend such JPT meeting by providing notification in writing to the other
Party’s Alliance Manager and following provision of such written notification
the alternate will be entitled to perform the functions of such JPT
representative at such JPT meeting. The Alliance Managers may attend meetings of
the JPT but shall have no right to vote on any decisions of the JPT.

 

2.2JPT Responsibilities for Research Plan. The JPT shall have overall
responsibility for monitoring the activities of the Parties under this Agreement
during the applicable Research Plan. The JPT shall, in particular:

 

(a)work to resolve, through good faith discussions, any dispute, controversy or
claim related to the matters under the authority of the JPT;

 

(b)approve each Research Plan and recommend to the JSC any material changes to
the Research Plan, including updating the Research Plan;

 

(c)monitor performance of the Research Plan; and

 

(d)review any data arising from the Research Plan.

 

2.3JPT Decision Making.

 

(a)With respect to the responsibilities of the JPT, each Party shall have one
vote on all matters brought before the JPT and the JPT shall operate by
unanimous vote. If the JPT is unable to achieve a unanimous vote within thirty
(30) days of any matter being brought before the JPT, then such matter may be
referred in writing to the JSC at either Party’s discretion. Each Party shall
make decisions within the JPT in good faith and on a timely basis; provided that
any JPT decisions shall be subject to the conditions applied to JSC decisions,
as set forth in Paragraph 1.3 above.

 

2.4Ad-hoc Committees. The JSC or JPT, as appropriate, may also authorise the
setting up of sub-committees in relation to particular or specific aspects of
any Research Plan or other performance of this Agreement. Such sub-committees
shall act in the same way as the JPT and regularly report in to the relevant
JPT.

 

 

 

 

  

3.Meetings.

 

3.1JSC Meetings. The JSC shall meet at least once every six calendar months at
Adaptimmune’s facilities in Abingdon, Oxfordshire, England or at Noile-Immune’s
facilities in Tokyo, Japan, or via teleconference or otherwise, in each case as
agreed by the JSC.

 

3.2JPT Meetings. Each JPT shall meet once every calendar month at Adaptimmune’s
facilities in Abingdon, Oxfordshire, England or at Noile-Immune’s facilities in
Tokyo, Japan, or via teleconference or otherwise, in each case as agreed by the
JPT. Where possible, meetings will be held by telephone conference. Where
necessary, for example to resolve any dispute or to agree upon changes to any
Research Plan, as applicable, the JPT shall meet more frequently.

 

3.3Meeting Agendas and Minutes. Not later than thirty (30) days after each of
the JSC or JPT as applicable, are formed, the respective committees shall each
hold an organizational meeting by videoconference or teleconference to establish
their respective operating procedures, including establishment of agendas, and
preparation and approvals of minutes. The Parties shall alternate responsibility
for taking the meeting minutes; provided that Adaptimmune shall be responsible
for taking the meeting minutes at the first meeting of each committee or team.
Meeting minutes shall be sent to both Parties promptly (and in any event within
fourteen (14) days) after a meeting for review, comment and approval by each
Party. Where minutes are not approved by both Parties, the dispute shall be
resolved at the next committee or team meeting. A decision that is made at any
meeting shall be recorded in meeting minutes.

 

3.4General. Employees of each Party, other than its nominated committee or team
representatives, may attend meetings of the JSC and JPT as non-voting
participants. Each Party shall be responsible for all of its own expenses of
participating in the JSC or JPT. In addition each Party may nominate the same
individuals as representatives on multiple committees.

 

4.Dissolution.

 

4.1Dissolution of JSC. The JSC shall dissolve on termination of this Agreement
or completion of all Research Plans.

 

4.2Dissolution of JPT. The JPT shall automatically dissolve on completion of the
applicable Research Plan or, if earlier, termination of this Agreement.

 

4.3Dissolution of Ad-hoc sub-committees. Each Ad-hoc sub-committee will be
deemed dissolved by the Parties on completion of the relevant activity in
relation to which the sub-committee was set up.

 

 

 

  

Exhibit 5 – Noile-Immune Patents

 

[***]             [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
[***] [***]     [***] [***] [***] [***] [***]     [***] [***] [***] [***] [***]
[***] [***] [***] [***] [***] [***] [***]     [***] [***] [***] [***] [***]    
[***] [***] [***] [***] [***]     [***] [***] [***] [***] [***]     [***] [***]
[***] [***] [***]     [***] [***] [***] [***] [***]     [***] [***] [***] [***]
[***]     [***] [***] [***] [***] [***]     [***] [***] [***] [***] [***]    
[***] [***] [***] [***] [***]     [***] [***] [***] [***] [***]     [***] [***]
[***] [***] [***]     [***] [***] [***] [***] [***]     [***] [***] [***] [***]
[***]     [***] [***] [***] [***] [***]     [***] [***] [***] [***] [***]    
[***] [***] [***] [***] [***]     [***] [***] [***] [***] [***]     [***] [***]
[***] [***] [***]     [***] [***] [***] [***] [***]     [***] [***] [***] [***]
[***]                   [***]            

[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]    
[***] [***] [***] [***] [***]    

 

 

 

 

Exhibit 6 – Press Release

  

 

 

 

Adaptimmune and Noile-Immune Announce Agreement to Develop SPEAR T-Cell Products
expressing
IL-7 and CCL19 as a next-generation treatment for cancer patients

 

- The collaboration will develop Adaptimmune’s SPEAR T-cells in combination with
Noile-Immune’s PRIME (IL-7 and CCL19) technology to improve proliferation and
trafficking of T-cells to tackle solid tumors -

 

PHILADELPHIA and OXFORDSHIRE, United Kingdom, Aug. 27, 2019 (GLOBE NEWSWIRE) -
Adaptimmune Therapeutics plc, Philadelphia, PA, and Oxfordshire, UK
(Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, and Noile-Immune
Biotech, Inc., Tokyo, Japan, a biotechnology company focusing on the development
of innovative cancer immunotherapies, today announced that they will co-develop
next-generation SPEAR T-cell products, incorporating Noile-Immune’s PRIME
(proliferation inducing and migration enhancing) technology, based upon
co-expression of IL-7 and CCL19. The PRIME technology, which is already being
investigated for augmentation of CAR-T cell activity, will be investigated with
Adaptimmune’s SPEAR T-cells, as part of Adaptimmune’s next-generation programs.

 

“We recently started our Phase 2 trial in sarcoma called SPEARHEAD-1 as well as
the SURPASS trial, our first next-generation product clinical trial. We will
continue to develop enhanced products with the aim of increasing the efficacy
and durability of anti-tumor responses,” said Karen Miller, Adaptimmune’s Senior
Vice President of Pipeline Research. “This agreement with Noile-Immune will
enable us to generate next-generation SPEAR T-cells secreting both IL-7 and
CCL19, which may improve proliferation and trafficking of not only our
engineered SPEAR T-cells, but also the patient’s own T-cells into solid tumors.
This increased T-cell proliferation and trafficking may enhance anti-tumor
activity for cancer patients.”

 

“We are very pleased to step into co-development of next-generation T-cell
products with Adaptimmune,” said Hidenobu Ishizaki, M.D., Ph.D., President & CEO
of Noile-Immune. “This agreement is another example of our collaborations to
apply PRIME technology, which was invented by Dr. Koji Tamada, our scientific
founder, to highly innovative cell therapies, and to work with top external
scientific and clinical teams. This technology may establish more effective
cancer treatments that address the needs of patients.”

 

Under the terms of the agreement, Noile-Immune and Adaptimmune will collaborate
on preclinical development of next-generation SPEAR T-cells directed to a
limited number of T-cell targets incorporating Noile-Immune’s PRIME technology.
Adaptimmune will have exclusive rights to develop and commercialize resulting
products on a worldwide basis. Adaptimmune will make an upfront cash payment and
milestone payments to Noile-Immune of up to $312M across all programs.
Noile-Immune is also entitled to receive mid-single digit royalties on net sales
of resulting products. The companies plan to gain regulatory approval for human
testing of the first target program by 2021.

 

About Adaptimmune

Adaptimmune is a clinical-stage biopharmaceutical company focused on the
development of novel cancer immunotherapy products for cancer patients. The
Company’s unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell
platform enables the engineering of T-cells to target and destroy cancer across
multiple solid tumors. For more information, please visit
http://www.adaptimmune.com.

 

About Noile-Immune

Noile-Immune Biotech, Inc., based in Tokyo, Japan, is a biotechnology company
focused on the development and commercialization of novel cancer immunotherapy
products to eradicate cancer cells. The Company’s goal is to discover and
develop innovative cancer immunotherapies through partnerships with experts in
industry and academia, including Yamaguchi University and The National Cancer
Center (NCC) in Japan. For more information, please visit
https://www.noile-immune.com/english/home/.

  

 

 

 

Adaptimmune Forward-Looking Statements

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 Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission (SEC) on
August 1, 2019, and our other SEC filings. 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:

   

Media Relations:

Sébastien Desprez – VP, Communications and Investor Relations

T: +44 1235 430 583

M: +44 7718 453 176

Sebastien.Desprez@adaptimmune.com

  

Investor Relations:

Juli P. Miller, Ph.D. – Senior Director, Investor Relations

T: +1 215 825 9310

M: +1 215 460 8920

Juli.Miller@adaptimmune.com

 

Noile-Immune Contact:

Tsutom Tokashiki – SVP, Business

ir@noile-immune.com